[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Rules and Regulations]
[Pages 27498-27901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09581]



[[Page 27497]]

Vol. 81

Friday,

No. 88

May 6, 2016

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 431, 433, 438, et al.





Medicaid and Children's Health Insurance Program (CHIP) Programs; 
Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions 
Related to Third Party Liability; Final Rule

  Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and 
Regulations  

[[Page 27498]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 431, 433, 438, 440, 457 and 495

[CMS-2390-F]
RIN 0938-AS25


Medicaid and Children's Health Insurance Program (CHIP) Programs; 
Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions 
Related to Third Party Liability

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule modernizes the Medicaid managed care 
regulations to reflect changes in the usage of managed care delivery 
systems. The final rule aligns, where feasible, many of the rules 
governing Medicaid managed care with those of other major sources of 
coverage, including coverage through Qualified Health Plans and 
Medicare Advantage plans; implements statutory provisions; strengthens 
actuarial soundness payment provisions to promote the accountability of 
Medicaid managed care program rates; and promotes the quality of care 
and strengthens efforts to reform delivery systems that serve Medicaid 
and CHIP beneficiaries. It also ensures appropriate beneficiary 
protections and enhances policies related to program integrity. This 
final rule also implements provisions of the Children's Health 
Insurance Program Reauthorization Act of 2009 (CHIPRA) and addresses 
third party liability for trauma codes.

DATES: Except for 42 CFR 433.15(b)(10) and Sec.  438.370, these 
regulations are effective on July 5, 2016. The amendments to Sec. Sec.  
433.15(b)(10) and 438.370, are effective May 6, 2016.
    Compliance Date: See the Compliance section of the Supplementary 
Information.

FOR FURTHER INFORMATION CONTACT: Nicole Kaufman, (410) 786-6604, 
Medicaid Managed Care Operations.
    Heather Hostetler, (410) 786-4515, Medicaid Managed Care Quality.
    Melissa Williams, (410) 786-4435, CHIP.
    Nancy Dieter, (410) 786-7219, Third Party Liability.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Medicaid Managed Care
    A. Background
    B. Summary of Proposed Provisions and Analysis of and Responses 
to Comments
    1. Alignment With Other Health Coverage Programs
    a. Marketing
    b. Appeals and Grievances
    c. Medical Loss Ratio
    2. Standard Contract Provisions
    a. CMS Review
    b. Entities Eligible for Comprehensive Risk Contracts
    c. Payment
    d. Enrollment Discrimination Prohibited
    e. Services That May Be Covered by an MCO, PIHP, or PAHP
    f. Compliance With Applicable Laws and Conflict of Interest 
Safeguards
    g. Provider-Preventable Condition Requirements
    h. Inspection and Audit of Records and Access to Facilities
    i. Physician Incentive Plans
    j. Advance Directives
    k. Subcontracts
    l. Choice of Health Professional
    m. Audited Financial Reports
    n. LTSS Contract Requirements
    o. Special Rules for Certain HIOs
    p. Additional Rules for Contracts With PCCMs and PCCM Entities
    q. Requirements for MCOs, PIHPs, or PAHPs That Provide Covered 
Outpatient Drugs
    r. Requirements for MCOs, PIHPs, or PAHPs Responsible for 
Coordinating Benefits for Dually Eligible Individuals
    s. Payments to MCOs and PIHPs for Enrollees That Are a Patient 
in an Institution for Mental Disease
    t. Recordkeeping Requirements
    3. Setting Actuarially Sound Capitation Rates for Medicaid 
Managed Care Programs
    a. Definitions
    b. Actuarial Soundness Standards
    c. Rate Development Standards
    d. Special Contract Provisions Related to Payment
    e. Rate Certification Submission
    4. Other Payment and Accountability Improvements
    a. Prohibition of Additional Payments for Services Covered Under 
MCO, PIHP, or PAHP Contracts
    b. Subcontractual Relationships and Delegation
    c. Program Integrity
    d. Sanctions
    e. Deferral and/or Disallowance of FFP for Non-compliance With 
Federal Standards
    f. Exclusion of Entities
    5. Beneficiary Protections
    a. Enrollment
    b. Disenrollment Standards and Limitations
    c. Beneficiary Support System
    d. Coverage and Authorization of Services and Continuation of 
Benefits While the MCO, PIHP, or PAHP Appeal and the State Fair 
Hearing Are Pending
    e. Continued Services to Beneficiaries and Coordination and 
Continuity of Care
    f. Advancing Health Information Exchange
    g. Managed Long-Term Services and Supports
    h. Stakeholder Engagement for MLTSS
    6. Modernize Regulatory Requirements
    a. Availability of Services, Assurances of Adequate Capacity and 
Services, and Network Adequacy Standards
    b. Quality of Care
    c. State Monitoring Standards
    d. Information Requirements
    e. Primary Care Case Management
    f. Choice of MCOs, PIHPs, PAHPs, PCCMs and PCCM Entities
    g. Non-Emergency Medicaid Transportation PAHPs
    h. State Plan Requirements
    7. Implementing Statutory Provisions
    a. Encounter Data and Health Information Systems
    b. Standards for Contracts Involving Indians, Indian Health Care 
Providers and Indian Managed Care Entities
    c. Emergency and Post-Stabilization Services
    8. Other Provisions
    a. Provider Discrimination Prohibited
    b. Enrollee Rights
    c. Provider-Enrollee Communications
    d. Liability for Payment
    e. Cost Sharing
    f. Solvency Standards
    g. Confidentiality
    h. Practice Guidelines
    9. Definitions and Technical Corrections
    a. Definitions
    b. Technical Corrections
    c. Applicability and compliance dates
II. CHIP Requirements
    A. Background
    B. Summary of Proposed Provisions and Analysis of and Responses 
to Comments
    1. Definitions
    2. Federal Financial Participation
    3. Basis, Scope, and Applicability
    4. Contracting Requirements
    5. Rate Development Standards and Medical Loss Ratio
    6. Non-Emergency Medical Transportation PAHPs
    7. Information Requirements
    8. Requirement Related to Indians, Indian Health Care Providers, 
and Indian Managed Care Entities
    9. Managed Care Enrollment, Disenrollment, and Continued 
Services to Beneficiaries
    10. Conflict of Interest Safeguards
    11. Network Adequacy Standards
    12. Enrollee Rights
    13. Provider-Enrollee Communication
    14. Marketing Activities
    15. Liability for Payment
    16. Emergency and Poststabilization Services
    17. Access Standards
    18. Structure and Operation Standards
    19. Quality Measurement and Improvement
    20. External Quality Review
    21. Grievances
    22. Sanctions
    23. Program Integrity--Conditions Necessary to Contract as an 
MCO, PAHP, or PIHP
III. Third Party Liability
    A. Background
    B. Summary of Proposed Provisions and Analysis of and Responses 
to Comments

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IV. Finding of Good Cause, Waiver of Delay in Effective Date
    V. Collection of Information Requirements
    VI. Regulatory Impact Analysis

Acronyms

    Because of the many organizations and terms to which we refer by 
acronym in this final rule, we are listing these acronyms and their 
corresponding terms in alphabetical order below:

ACO Accountable Care Organization
[the] Act Social Security Act
Affordable Care Act The Affordable Care Act of 2010 (which is the 
collective term for the Patient Protection and Affordable Care Act 
(Pub. L. 111-148) and the Health Care Education Reconciliation Act 
(Pub. L. 111-152)
ARRA American Recovery and Reinvestment Act of 2009
ASOP Actuarial Standard of Practice
BBA Balanced Budget Act of 1997
BIA Bureau of Indian Affairs
CPE Certified Public Expenditure
CFR Code of Federal Regulations
CBE Community Benefit Expenditures
CHIP Children's Health Insurance Program
CHIPRA Children's Health Insurance Program Reauthorization Act of 
2009
CMS Centers for Medicare & Medicaid Services
DUR Drug Utilization Review [program]
EQR External Quality Review
EQRO External Quality Review Organization
FFM Federally-Facilitated Marketplaces
FFP Federal Financial Participation
FFS Fee-For-Service
FMAP Federal Medical Assistance Percentage
FQHC Federally Qualified Health Center
FY Fiscal Year
HHS [U.S. Department of] Health and Human Services
HIO Health Insuring Organization
HIPAA Health Insurance Portability and Accountability Act of 1996
ICD International Classification of Diseases
IGT Intergovernmental Transfer
IHCP Indian Health Care Provider
LEP Limited English Proficiency
LTSS Long-Term Services and Supports
MA Medicare Advantage
MACPAC Medicaid and CHIP Payment and Access Commission
MMC QRS Medicaid Managed Care Quality Rating System
MCO Managed Care Organization
MFCU Medicaid Fraud Control Unit
MHPA Mental Health Parity Act of 1996
MH/SUD Mental Health/Substance Use Disorder Services
MHPAEA Mental Health Parity and Addiction Equity Act
MLTSS Managed Long-Term Services and Supports
MLR Medical Loss Ratio
MSIS Medicaid Statistical Information System
NAMD National Association of Medicaid Directors
NCQA National Committee for Quality Assurance
NEMT Non-Emergency Medical Transportation
NQF National Quality Forum
OMB Office of Management and Budget
PCCM Primary Care Case Manager
PHS Public Health Service Act
PIP Performance Improvement Project
PMPM Per-member Per-month
PAHP Pre-paid Ambulatory Health Plan
PIHP Pre-paid Inpatient Health Plan
QAPI Quality Assessment and Performance Improvement
QHP Qualified Health Plan(s)
QRS Quality Rating System
SHO State Health Official Letter
SBC Summary of Benefits and Coverage
SBM State-Based Marketplaces
SIU Special Investigation Unit
SMDL State Medicaid Director Letter
T-MSIS Transformed Medicaid Statistical Information System
TPL Third Party Liability

Compliance

    States must be in compliance with the requirements at Sec.  438.370 
and Sec.  431.15(b)(10) of this rule immediately. States must be in 
compliance with the requirements at Sec. Sec.  431.200, 431.220, 
431.244, 433.138, 438.1, 438.2, 438.3(a) through (g), 438.3(i) through 
(l), 438.3(n) through (p), 438.4(a), 438.4(b)(1), 438.4(b)(2), 
438.4(b)(5), 438.4(b)(6), 438.5(a), 438.5(g), 438.6(a), 438.6(b)(1), 
438.6(b)(2), 438.6(e), 438.7(a), 438.7(d), 438.12, 438.50, 438.52, 
438.54, 438.56 (except 438.56(d)(2)(iv)), 438.58, 438.60, 438.100, 
438.102, 438.104, 438.106, 438.108, 438.114, 438.116, 438.214, 438.224, 
438.228, 438.236, 438.310, 438.320, 438.352, 438.600, 438.602(i), 
438.610, 438.700, 438.702, 438.704, 438.706, 438.708, 438.710, 438.722, 
438.724, 438.726, 438.730, 438.802, 438.806, 438.808, 438.810, 438.812, 
438.816, 440.262, 495.332, 495.366 and 457.204 no later than the 
effective date of this rule.
    For rating periods for Medicaid managed care contracts beginning 
before July 1, 2017, States will not be held out of compliance with the 
changes adopted in the following sections so long as they comply with 
the corresponding standard(s) codified in 42 CFR part 438 contained in 
42 CFR parts 430 to 481, edition revised as of October 1, 2015: 
Sec. Sec.  438.3(h), 438.3(m), 438.3(q) through (u), 438.4(b)(7), 
438.4(b)(8), 438.5(b) through (f), 438.6(b)(3), 438.6(c) and (d), 
438.7(b), 438.7(c)(1) and (2), 438.8, 438.9, 438.10, 438.14, 
438.56(d)(2)(iv), 438.66(a) through (d), 438.70, 438.74, 438.110, 
438.208, 438.210, 438.230, 438.242, 438.330, 438.332, 438.400, 438.402, 
438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.420, 438.424, 
438.602(a), 438.602(c) through (h), 438.604, 438.606, 438.608(a), and 
438.608(c) and (d), no later than the rating period for Medicaid 
managed care contracts starting on or after July 1, 2017. States must 
comply with these requirements no later than the rating period for 
Medicaid managed care contracts starting on or after July 1, 2017.
    For rating periods for Medicaid managed care contracts beginning 
before July 1, 2018, states will not be held out of compliance with the 
changes adopted in the following sections so long as they comply with 
the corresponding standard(s) codified in 42 CFR part 438 contained in 
the 42 CFR parts 430 to 481, edition revised as of October 1, 2015: 
Sec. Sec.  438.4(b)(3), 438.4(b)(4), 438.7(c)(3), 438.62, 438.68, 
438.71, 438.206, 438.207, 438.602(b), 438.608(b), and 438.818. States 
must comply with these requirements no later than the rating period for 
Medicaid managed care contracts starting on or after July 1, 2018.
    States must be in compliance with the requirements at Sec.  
438.4(b)(9) no later than the rating period for Medicaid managed care 
contracts starting on or after July 1, 2019.
    States must be in compliance with the requirements at Sec.  
438.66(e) no later than the rating period for Medicaid managed care 
contracts starting on or after the date of the publication of CMS 
guidance.
    States must be in compliance with Sec.  438.334 no later than 3 
years from the date of a final notice published in the Federal 
Register. Until July 1, 2018, states will not be held out of compliance 
with the changes adopted in the following sections so long as they 
comply with the corresponding standard(s) codified in 42 CFR part 438 
contained in the 42 CFR parts 430 to 481, edition revised as of October 
1, 2015: Sec. Sec.  438.340, 438.350, 438.354, 438.356, 438.358, 
438.360, 438.362, and 438.364. States must begin conducting the EQR-
related activity described in Sec.  438.358(b)(1)(iv) (relating to the 
mandatory EQR-related activity of validation of network adequacy) no 
later than one year from the issuance of the associated EQR protocol. 
States may begin conducting the EQR-related activity described in Sec.  
438.358(c)(6) (relating to the optional EQR-related activity of plan 
rating) no earlier than the issuance of the associated EQR protocol.
    Except as otherwise noted, states will not be held out of 
compliance with new requirements in part 457 of this final rule until 
CHIP managed care contracts as of the state fiscal year beginning on or 
after July 1, 2018, so long as they comply with the corresponding 
standard(s) in 42 CFR part 457 contained in the 42 CFR, parts 430 to 
481, edition revised as of October 1, 2015. States must come into 
compliance

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with Sec.  457.1240(d) no later than 3 years from the date of a final 
notice published in the Federal Register. States must begin conducting 
the EQR-related activity described in Sec.  438.358(b)(1)(iv) (relating 
to the mandatory EQR-related activity of validation of network 
adequacy) which is applied to CHIP per Sec.  457.1250 no later than one 
year from the issuance of the associated EQR protocol.

I. Medicaid Managed Care

A. Background

    In 1965, amendments to the Social Security Act (the Act) 
established the Medicaid program as a joint federal and state program 
to provide medical assistance to individuals with low incomes. Under 
the Medicaid program, each state that chooses to participate in the 
program and receive federal financial participation (FFP) for program 
expenditures, establishes eligibility standards, benefits packages, and 
payment rates, and undertakes program administration in accordance with 
federal statutory and regulatory standards. The provisions of each 
state's Medicaid program are described in the state's Medicaid ``state 
plan.'' Among other responsibilities, the Centers for Medicare and 
Medicaid Services (CMS) approves state plans and monitors activities 
and expenditures for compliance with federal Medicaid laws to ensure 
that beneficiaries receive timely access to quality health care. 
(Throughout this preamble, we use the term ``beneficiaries'' to mean 
``individuals eligible for Medicaid benefits.'')
    Until the early 1990s, most Medicaid beneficiaries received 
Medicaid coverage through fee-for-service (FFS) arrangements. However, 
over time that practice has shifted and states are increasingly 
utilizing managed care arrangements to provide Medicaid coverage to 
beneficiaries. Under managed care, beneficiaries receive part or all of 
their Medicaid services from health care providers that are paid by an 
organization that is under contract with the state; the organization 
receives a monthly capitated payment for a specified benefit package 
and is responsible for the provision and coverage of services. In 1992, 
2.4 million Medicaid beneficiaries (or 8 percent of all Medicaid 
beneficiaries) accessed part or all of their Medicaid benefits through 
capitated health plans; by 1998, that number had increased fivefold to 
12.6 million (or 41 percent of all Medicaid beneficiaries). As of July 
1, 2013, more than 45.9 million (or 73.5 percent of all Medicaid 
beneficiaries) accessed part or all of their Medicaid benefits through 
Medicaid managed care.\1\ In FY 2013, approximately 4.3 million 
children enrolled in CHIP (or about 81 percent of all separate CHIP 
beneficiaries) were enrolled in managed care.
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    \1\ CMS, 2013 Medicaid Managed Care Enrollment Report, available 
at https://www.medicaid.gov/medicaid-chip-program-information/by-topics/data-and-systems/medicaid-managed-care/medicaid-managed-care-enrollment-report.html.
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    In a Medicaid managed care delivery system, through contracts with 
managed care plans, states require that the plan provide or arrange for 
a specified package of Medicaid services for enrolled beneficiaries. 
States may contract with managed care entities that offer comprehensive 
benefits, referred to as managed care organizations (MCOs). Under these 
contracts, the organization offering the managed care plan is paid a 
fixed, prospective, monthly payment for each enrolled beneficiary. This 
payment approach is referred to as ``capitation.'' Beneficiaries 
enrolled in capitated MCOs must access the Medicaid services covered 
under the state plan through the managed care plan. Alternatively, 
managed care plans can receive a capitated payment for a limited array 
of services, such as behavioral health or dental services. Such 
entities that receive a capitated payment for a limited array of 
services are referred to as ``prepaid inpatient health plans'' (PIHPs) 
or ``prepaid ambulatory health plans'' (PAHPs) depending on the scope 
of services the managed care plan provides. Finally, applicable federal 
statute recognizes primary care case managers (PCCM) as a type of 
managed care entity subject to some of the same standards as MCOs; 
states that do not pursue capitated arrangements but want to promote 
coordination and care management may contract with primary care 
providers or care management entities for primary care case management 
services to support better health outcomes and improve the quality of 
care delivered to beneficiaries, but continue to pay for covered 
benefits on a FFS basis directly to the health care provider.
    Comprehensive regulations to cover managed care delivery mechanisms 
for Medicaid were adopted in 2002 after a series of proposed and 
interim rules. Since the publication of those Medicaid managed care 
regulations in 2002, the landscape for health care delivery has 
continued to change, both within the Medicaid program and outside (in 
Medicare and the private sector market). States have continued to 
expand the use of managed care over the past decade, serving both new 
geographic areas and broader groups of Medicaid beneficiaries. In 
particular, states have expanded managed care delivery systems to 
include older adults and persons with disabilities, as well as those 
who need long-term services and supports (LTSS). In 2004, eight states 
(AZ, FL, MA, MI, MN, NY, TX, and WI) had implemented Medicaid managed 
long-term services and supports (MLTSS) programs. By January 2014, 12 
additional states had implemented MLTSS programs (CA, DE, IL, KS, NC, 
NM, OH, PA, RI, TN, VA, WA).
    States may implement a Medicaid managed care delivery system under 
four types of federal authorities:
    (1) Section 1915(a) of the Act permits states with a waiver to 
implement a voluntary managed care program by executing a contract with 
organizations that the state has procured using a competitive 
procurement process.
    (2) Through a state plan amendment that meets standards set forth 
in section 1932 of the Act, states can implement a mandatory managed 
care delivery system. This authority does not allow states to require 
beneficiaries who are dually eligible for Medicare and Medicaid (dually 
eligible), American Indians/Alaska Natives, or children with special 
health care needs to enroll in a managed care program. State plans, 
once approved, remain in effect until modified by the state.
    (3) CMS may grant a waiver under section 1915(b) of the Act, 
permitting a state to require all Medicaid beneficiaries to enroll in a 
managed care delivery system, including dually eligible beneficiaries, 
American Indians/Alaska Natives, or children with special health care 
needs. After approval, a state may operate a section 1915(b) waiver for 
up to a 2-year period (certain waivers can be operated for up to 5 
years if they include dually eligible beneficiaries) before requesting 
a renewal for an additional 2 (or 5) year period.
    (4) CMS may also authorize managed care programs as part of 
demonstration projects under section 1115(a) of the Act using waivers 
permitting the state to require all Medicaid beneficiaries to enroll in 
a managed care delivery system, including dually eligible 
beneficiaries, American Indians/Alaska Natives, and children with 
special health care needs. Under this authority, states may seek 
additional flexibility to demonstrate and evaluate innovative policy 
approaches for delivering Medicaid benefits, as well as the option to 
provide services not typically covered by Medicaid. Such flexibility is 
approvable only if the objectives of the Medicaid statute are likely to 
be met, the demonstration satisfies budget

[[Page 27501]]

neutrality requirements, and the demonstration is subject to 
evaluation.
    All of these authorities may permit states to operate their 
programs without complying with the following standards of Medicaid law 
outlined in section of 1902 of the Act:
     Statewideness [section 1902(a)(1) of the Act]: States may 
implement a managed care delivery system in specific areas of the State 
(generally counties/parishes) rather than the whole state;
     Comparability of Services [section 1902(a)(10) of the 
Act]: States may provide different benefits to beneficiaries enrolled 
in a managed care delivery system; and
     Freedom of Choice [section 1902(a)(23)(A) of the Act]: 
States may require beneficiaries to receive their Medicaid services 
only from a managed care plan or primary care provider.
    The health care delivery landscape has changed substantially, both 
within the Medicaid program and outside of it. Reflecting the 
significant role that managed care plays in the Medicaid program and 
these substantial changes, this rule modernizes the Medicaid managed 
care regulatory structure to facilitate and support delivery system 
reform initiatives to improve health care outcomes and the beneficiary 
experience while effectively managing costs. The rule also includes 
provisions that strengthen the quality of care provided to Medicaid 
beneficiaries and promote more effective use of data in overseeing 
managed care programs. In addition, this final rule revises the 
Medicaid managed care regulations to align, where appropriate, with 
requirements for other sources of coverage, strengthens actuarial 
soundness and other payment regulations to improve accountability of 
capitation rates paid in the Medicaid managed care program, and 
incorporates statutory provisions affecting Medicaid managed care 
passed since 2002. This final rule also recognizes that through managed 
care plans, state and federal taxpayer dollars are used to purchase 
covered services from providers on behalf of Medicaid enrollees, and 
adopts procedures and standards to ensure accountability and strengthen 
program integrity safeguards to ensure the appropriate stewardship of 
those funds.

B. Summary of Proposed Provisions and Analysis of and Responses to 
Comments

    In the June 1, 2015 Federal Register (80 FR 31097 through 31297), 
we published the ``Medicaid and Children's Health Insurance Program 
(CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, 
Medicaid and CHIP Comprehensive Quality Strategies, and Revisions 
Related to Third Party Liability'' proposed rule which proposed 
revisions to align many of the rules governing Medicaid managed care 
with those of other major sources of coverage, where appropriate; 
enhance the beneficiary experience; implement statutory provisions; 
strengthen actuarial soundness payment provisions and program integrity 
standards; and promote the quality of care and strengthen efforts to 
reform delivery systems that serve Medicaid and CHIP beneficiaries. We 
also proposed to require states to establish comprehensive quality 
strategies that applied to all services covered under state Medicaid 
and CHIP programs, not just those covered through an MCO or PIHP.
    In the proposed rule and in this final rule, we restated the 
entirety of part 438 and incorporated our changes into the regulation 
text due to the extensive nature of our proposals. However, for many 
sections within part 438, we did not propose, and do not finalize, 
substantive changes.
    Throughout this document, the use of the term ``managed care plan'' 
incorporates MCOs, PIHPs, and PAHPs and is used only when the provision 
under discussion applies to all three arrangements. An explicit 
reference is used in the preamble if the provision applies to PCCMs, 
PCCM entities, or only to MCOs. In addition, many of our proposals 
incorporated ``PCCM entities'' into existing regulatory provisions and 
the proposed amendments.
    Throughout this document, the term ``PAHP'' is used to mean a 
prepaid ambulatory health plan that does not exclusively provide non-
emergency medical transportation (NEMT) services. Whenever this 
document is referencing a PAHP that exclusively provides NEMT services, 
it will be specifically addressed as a ``Non-Emergency Medical 
Transportation (NEMT) PAHP.''
    We received a total of 879 timely comments from State Medicaid 
agencies, advocacy groups, health care providers and associations, 
health insurers, managed care plans, health care associations, and the 
general public. The comments ranged from general support or opposition 
to the proposed provisions to very specific questions or comments 
regarding the proposed changes. In response to the proposed rule, many 
commenters chose to raise issues that are beyond the scope of our 
proposals. In this final rule, we are not summarizing or responding to 
those comments in this document. However, we may consider whether to 
take other actions, such as revising or clarifying CMS program 
operating instructions or procedures, based on the information or 
recommendations in the comments.
    Brief summaries of each proposed provision, a summary of the public 
comments we received (with the exception of specific comments on the 
paperwork burden or the economic impact analysis), and our responses to 
the comments are provided in this final rule. Comments related to the 
paperwork burden and the impact analyses included in the proposed rule 
are addressed in the ``Collection of Information Requirements'' and 
``Regulatory Impact Analysis'' sections in this final rule. The final 
regulation text follows these analyses.
    The following summarizes comments about the proposed rule, in 
general, or regarding issues not contained in specific provisions:
    Comment: We received several comments specific to provider 
reimbursement for federally qualified health centers (FQHCs) and 
hospice providers. Many commenters submitted concerns about state-
specific programs or proposals.
    Response: While we did not propose explicit regulations in those 
areas, we acknowledge receipt of these comments and may consider the 
concerns raised therein for future guidance. We have addressed concerns 
raised by these providers when directly responsive to provisions in the 
proposed rule. In addition, we appreciate commenters alerting us to 
concerns and considerations for state-specific programs or proposals 
and have shared those comments within CMS.
I.B.1. Alignment With Other Health Coverage Programs
a. Marketing (Sec.  438.104)
    As we noted in the proposed rule in section I.B.1.a., the current 
regulation at Sec.  438.104 imposes certain limits on MCOs, PIHPs, 
PAHPs, and PCCMs in connection with marketing activities; our 2002 
final rule based these limits on section 1932(d)(2) of the Act for MCOs 
and PCCMs and extended them to PIHPs and PAHPs using our authority at 
section 1902(a)(4) of the Act. The creation of qualified health plans 
(QHPs) by the Affordable Care Act and changes in managed care delivery 
systems since the adoption of the 2002 rule are the principal reasons 
behind our proposal to revise the marketing standards applicable to 
Medicaid managed care programs. QHPs are defined in 45 CFR 155.20.
    We proposed to revise Sec.  438.104(a) as follows: (1) To amend the 
definition of

[[Page 27502]]

``marketing'' in Sec.  438.104 to specifically exclude communications 
from a QHP to Medicaid beneficiaries even if the issuer of the QHP is 
also an entity providing Medicaid managed care; (2) to amend the 
definition of ``marketing materials;'' (3) to add a definition for 
``private insurance'' to clarify that QHPs certified for participation 
in the Federally-Facilitated Marketplace (FFM) or a State-Based 
Marketplace (SBM) are excluded from the term ``private insurance'' as 
it is used in this regulation; and (4) in recognition of the wide array 
of services PCCM entities provide in some markets, to include PCCM 
entities in Sec.  438.104 as we believed it was important to extend the 
beneficiary protections afforded by this section to enrollees of PCCM 
entities. This last proposal was to revise paragraphs (a) and (b) to 
include ``or PCCM entity'' wherever the phrase ``MCO, PIHP, PAHP or 
PCCM'' appears. We did not propose significant changes to paragraph 
(b), but did propose one clarifying change to (b)(1)(v) as noted below.
    Prior to the proposed rule, we had received several questions from 
Medicaid managed care plans about the implications of current Medicaid 
marketing rules in Sec.  438.104 for their operation of QHPs. 
Specifically, stakeholders asked whether the provisions of Sec.  
438.104(b)(1)(iv) would prohibit an issuer that offers both a QHP and a 
MCO from marketing both products. The regulatory provision implements 
section 1932(d)(2)(C) of the Act, titled ``Prohibition of Tie-Ins.'' In 
issuing regulations implementing this provision in 2002, we clarified 
that we interpreted it as intended to preclude tying enrollment in the 
Medicaid plan to purchasing other types of private insurance (67 FR 
41027). Therefore, it would not apply to the issue of a possible 
alternative to the Medicaid plan, which a QHP could be if the consumer 
was determined as not Medicaid eligible or loses Medicaid eligibility. 
Section 438.104(b)(1)(iv) only prohibits the marketing of insurance 
policies that would be sold ``in conjunction with'' enrollment in the 
Medicaid plan.
    We recognized that a single legal entity could be operating 
separate lines of business, that is, a Medicaid MCO (or PIHP or PAHP) 
and a QHP. Issuers of QHPs may also contract with states to provide 
Medicaid managed care plans; in some cases the issuer might be the MCO, 
PIHP, or PAHP itself, or the entity offering the Medicaid managed care 
plan, thus providing coverage to Medicaid beneficiaries. Many Medicaid 
managed care plan contracts with states executed prior to 2014 did not 
anticipate this situation and may contain broad language that could 
unintentionally result in the application of Medicaid standards to the 
non-Medicaid lines of business offered by the single legal entity. For 
example, if a state defines the entity subject to the contract through 
reference to something shared across lines of business, such as 
licensure as an insurer, both the Medicaid MCO and QHP could be subject 
to the terms of the contract with the state. To prevent ambiguity and 
overly broad restrictions, contracts should contain specific language 
to clearly define the state's intent that the contract is specific to 
the Medicaid plan being offered by the entity. This becomes critically 
important in the case of a single legal entity operating Medicaid and 
non-Medicaid lines of business. We recommended that states and Medicaid 
managed care plans review their contracts to ensure that it clearly 
defined each party's rights and responsibilities.
    Consumers who experience periodic transitions between Medicaid and 
QHP eligibility, and families who have members who are divided between 
Medicaid and QHP coverage may prefer an issuer that offers both types 
of products. Improving coordination of care and minimizing disruption 
to care is best achieved when the consumer has sufficient information 
about coverage options when making a plan selection. We noted that our 
proposed revisions would enable more complete and effective information 
sharing and consumer education while still upholding the intent of the 
Medicaid beneficiary protections detailed in the Act. Section 438.104 
alone does not prohibit a managed care plan from providing information 
on a QHP to enrollees who could potentially enroll in a QHP as an 
alternative to the Medicaid plan due to a loss of eligibility or to 
potential enrollees who may consider the benefits of selecting an MCO, 
PIHP, PAHP, or PCCM that has a related QHP in the event of future 
eligibility changes. We proposed minimum marketing standards that a 
state would be able to build on as part of its contracts with entities 
providing Medicaid managed care.
    Finally, we had received inquiries about the use of social media 
outlets for dissemination of marketing information about Medicaid 
managed care. The definition of ``marketing'' in Sec.  438.104 includes 
``any communication from'' an entity that provides Medicaid managed 
care (including MCOs, PIHPs, PAHPs, etc.) and ``marketing materials'' 
include materials that are produced in any medium. These definitions 
are sufficiently broad to include social media and we noted in the 
proposed rule that we intended to interpret and apply Sec.  438.104 as 
applicable to communication via social media and electronic means.
    In paragraph (b)(1)(v), we proposed to clarify the regulation text 
by adding unsolicited contact by email and texting as prohibited cold-
call marketing activities. We believed this revision necessary given 
the prevalence of electronic forms of communication.
    We intended the proposed revisions to clarify, for states and 
issuers, the scope of the marketing provisions in Sec.  438.104, which 
generally are more detailed and restrictive than those imposed on QHPs 
under 45 CFR 156.225. We indicated that while we believed that the 
Medicaid managed care regulation correctly provided significant 
protections for Medicaid beneficiaries, we recognized that the 
increased prevalence in some markets of issuers offering both QHP and 
Medicaid products and sought to provide more clear and targeted 
Medicaid managed care standards with our proposed changes.
    We received the following comments in response to our proposal to 
revise Sec.  438.104.
    Comment: We received many supportive comments for the proposed 
clarification in Sec.  438.104 that QHPs, as defined in 45 CFR 155.20, 
be excluded from the definitions of marketing and private insurance, as 
used in part 438. Commenters believed this would benefit enrollees and 
potential enrollees by providing them with more comprehensive 
information and enable them to make a more informed managed care plan 
selection.
    Response: We thank the commenters for their support of the proposed 
clarification regarding the applicability of Sec.  438.104 to QHPs.
    Comment: One commenter recommended that CMS not allow the non-
benefit component of the capitation rate to include expenses associated 
with marketing by managed care plans, and only permit expenses related 
to communications that educate enrollees on services and behavioral 
changes as a permissible type of non-benefit expense.
    Response: Marketing is permitted under section 1932(d)(2) of the 
Act, subject to the parameters specified in Sec.  438.104; therefore, 
we decline to remove proposed Sec.  438.104 or to add a prohibition on 
marketing altogether. Marketing conducted in accordance with Sec.  
438.104 would be a permissible component of the non-benefit costs of 
the capitation rate.

[[Page 27503]]

    Comment: We received several comments on the definition of 
marketing in proposed Sec.  438.104(a). A few commenters requested that 
CMS clarify that a managed care plan sending information to its 
enrollees addressing only healthy behavior, covered benefits, or the 
managed care plan's network was not considered marketing. A few 
commenters requested that CMS clarify that incentives for healthy 
behaviors or receipt of services (such as baby car seats) and 
sponsorships by a managed care plan (such as sporting events) are not 
considered marketing. We also received a comment requesting that CMS 
clarify that health plans can market all of their lines of business at 
public events, even if Medicaid-enrolled individuals may be in 
attendance.
    Response: We agree that a managed care plan sending information to 
its enrollees addressing healthy behaviors, covered benefits, the 
managed care plan's network, or incentives for healthy behaviors or 
receipt of services (for example, baby car seats) would not meet the 
definition of marketing in Sec.  438.104(a). However, use of this 
information to influence an enrollment decision by a potential enrollee 
is marketing. In Sec.  438.104(a), marketing is defined as a 
communication by an MCO, PIHP, PAHP, PCCM or PCCM entity to a Medicaid 
beneficiary that is not enrolled with that MCO, PIHP, PAHP, PCCM or 
PCCM that could reasonably be interpreted to influence the beneficiary 
to change enrollment to the organization that sent the communication. 
The act of sponsorship by a managed care plan may be considered 
communication under the definition of marketing if the state determines 
that the sponsorship does not comply with Sec.  438.104 or any state 
marketing rules; managed care plans should consult with their state to 
determine the permissibility of such activity. In addition, managed 
care plans should consult their contracts and state Medicaid agency to 
determine if other provisions exist that may prohibit or limit these 
types of activity. We appreciate the opportunity to also clarify that 
providing information about a managed care plan's other lines of 
business at a public event where the Medicaid eligibility status of the 
audience is unknown also would not be prohibited by the provisions of 
Sec.  438.104. However, marketing materials at such events that are 
about the Medicaid health plan are subject to Sec.  438.104(b) and (c). 
Materials or activities that are limited to other private insurance 
that is offered by an entity that also offers the Medicaid managed care 
contract would not be within the scope of Sec.  438.104. We believe 
that at public events where a consumer approaches the managed care plan 
for information, the provisions of Sec.  438.104 do not prohibit a 
managed care plan from responding truthfully and accurately to the 
consumer's request for information. While the circumstance described in 
the comment does not appear to violate Sec.  438.104, managed care 
plans should consult their contract and the state Medicaid agency to 
ascertain if other prohibitions or limitations on these types of 
activity exist.
    Comment: A few commenters requested that CMS codify the information 
published in FAQs on Medicaid.gov in January 2015 \2\ that clarified 
that managed care plans are permitted to provide information to their 
enrollees about their redetermination of eligibility obligation.
---------------------------------------------------------------------------

    \2\ https://www.medicaid.gov/federal-policy-guidance/federal-policy-guidance.html.
---------------------------------------------------------------------------

    Response: As published in the FAQs on January 16, 2015, there is no 
provision in Sec.  438.104 specifically addressing a Medicaid managed 
care plan's outreach to enrollees for eligibility redetermination 
purposes; therefore, the permissibility of this activity depends on the 
Medicaid managed care plan's contract with the state Medicaid agency. 
Materials and information that purely educate an enrollee of that 
Medicaid managed care plan on the importance of completing the State's 
Medicaid eligibility renewal process in a timely fashion would not meet 
the federal definition of marketing. However, Medicaid managed care 
plans should consult their contracts and the state Medicaid agency to 
ascertain if other provisions exist that may prohibit or limit such 
activity. We believe that addressing this issue in the 2015 FAQs and 
again in this response is sufficient and decline to revise Sec.  
438.104.
    Comment: One commenter recommended that CMS prohibit QHP marketing 
materials from referencing Medicaid or the Medicaid managed care plan. 
Another commenter recommended that CMS exempt a Medicaid managed care 
plan that is also a QHP from all of the provisions in Sec.  438.104. 
Another commenter recommended that CMS prohibit QHPs from doing 
targeted marketing, such as to healthy populations.
    Response: We do not agree with the commenter that QHPs should be 
prohibited from referencing their Medicaid managed care plan in their 
materials. Further, this Medicaid managed care regulation is not the 
forum in which to regulate QHPs directly, as opposed to regulating the 
activities of Medicaid managed care plans that are also (or also offer) 
QHPs. We believe that the inclusion of information on a QHP and the 
Medicaid managed care plan from the same issuer could provide potential 
enrollees and enrollees with information that will enable them to make 
more informed managed care plan selections. To the comment recommending 
exemption from Sec.  438.104 when the Medicaid managed care plan is the 
QHP, that is not possible since the Medicaid managed care plan must be 
subject to Sec.  438.104 to be compliant with section 1932(d)(2) of the 
Act. Additionally, some provisions in Sec.  438.104 are critical 
beneficiary protections, such as the prohibitions on providing 
inaccurate, false or misleading information. As explained in the 
preamble, to prevent ambiguity and overly broad restrictions, contracts 
should contain specific language to clearly define the state's intent 
and address whether the contract is specific to the Medicaid plan being 
offered by the entity or imposes obligations in connection with other 
health plans offered by the same entity. This becomes critically 
important in the case of a single legal entity operating Medicaid and 
non-Medicaid lines of business. To the comment regarding QHPs targeting 
their marketing efforts, placing prohibitions on QHPs that are not the 
managed care plan is outside the scope of this rule. However, as 
discussed above in this response, if the QHP and the Medicaid managed 
care plan are the same legal entity and the managed care plan's 
contract with the state Medicaid agency is not sufficiently clear, then 
the provisions of Sec.  438.104 could be incorporated into the contract 
to apply to the QHP. As stated in the preamble to the proposed rule, we 
recommend that states and Medicaid managed care plans review their 
contracts to ensure that they clearly define each party's rights and 
responsibilities in this area.
    Comment: Several commenters recommended that Sec.  438.104(a) 
exempt all types of health care coverage from the definition of Private 
Insurance. The commenters believed that issuers should be able to 
provide information to potential enrollees and enrollees on all of the 
sources of coverage and health plan products that they offer, including 
Medicare Advantage (MA), D-SNPs, and FIDE SNPs.
    Response: We do not agree that the definition of Private Insurance 
in Sec.  438.104(a) should exempt all types of health care coverage. We 
specifically proposed, and finalized, an exemption

[[Page 27504]]

for QHPs because of the high rate of Medicaid beneficiaries that move 
between Medicaid and the Marketplace, sometimes within short periods of 
time, and QHPs are provided through the private market. In the past, we 
have received questions as to whether ``private insurance'' included 
QHPs since QHPs are provided in the private market. As discussed in the 
proposed rule (80 FR 31102), section 1932(d)(2)(C) of the Act, which is 
implemented at Sec.  438.104(b)(1)(iv), prohibits the influence of 
enrollment into a Medicaid managed care plan with the sale or offering 
of any private insurance. Since 2002, the ``offering of any private 
insurance'' has been interpreted as any other type of insurance, 
unrelated of its relationship to health insurance, such as burial 
insurance. The explicit exemption for QHPs was to avoid any confusion 
that ``private insurance'' included health insurance policies through 
the private market. Types of health care coverage, such as integrated 
D-SNPs, are public health benefit programs that are not insurance. 
Therefore, they cannot be considered ``private insurance.''
    Comment: One commenter recommended that CMS remove the definition 
of private insurance proposed in Sec.  438.104(a). The commenter 
believes it could cause confusion since QHPs have been called private 
plans in other public documents and references. One commenter stated 
that by excluding QHPs from the definition of ``private insurance,'' 
some readers may assume that CMS intended to imply that QHPs were 
considered public plans. The commenter requested that CMS clarify its 
intent to be clear that QHPs are not public plans for the purposes of 
discount cards, copayment assistance, and coupon programs.
    Response: We understand the commenter's concern but do not agree 
that the definition and use of the term ``private insurance'' in Sec.  
438.104(a) and (b)(iv) will cause confusion for other uses of the term 
in other contexts. We also do not agree that consumers will infer that 
because we excluded QHPs from the definition of private insurance in 
Sec.  438.104(a) and (b)(iv) that they are to be considered public 
plans. We do not believe our definition will have implications for 
discount cards, copayment assistance, and coupon programs. Proposed 
Sec.  438.104(a) limits the definition of ``private insurance'' to the 
context of Sec.  438.104 and we believe that disclaimer is sufficient 
to avoid confusion over the use of ``private insurance'' in other 
contexts and for other purposes.
    Comment: We received one comment pointing out that, inconsistent 
with the rest of Sec.  438.104, the definition of marketing materials 
in proposed Sec.  438.104(a) does not include ``PCCM entity'' in 
paragraph (1).
    Response: We appreciate the commenter bringing this omission to our 
attention; we are revising the definition of marketing materials to 
include the term ``PCCM entity'' in this final rule.
    Comment: One commenter suggested that CMS consider making the 
marketing regulation apply to both prospective and existing plan 
membership and allow issuers to provide information on their QHP to 
existing plan Medicaid membership, as well as individuals who may lose 
eligibility with another managed care plan.
    Response: We interpret the comment to reference an issuer that that 
is both a QHP and a Medicaid managed care plan. Regardless whether the 
state contracts with a Medicaid managed care plan (or other state 
regulation of QHPs), Sec.  438.104 as amended in this final rule does 
not prohibit a Medicaid managed care plan from including materials 
about a QHP in the Medicaid plan's marketing materials. However, such 
materials are subject to all provisions in Sec.  438.104, including 
requirements that the marketing materials be reviewed by the state 
prior to distribution and be distributed throughout the entire service 
area of the Medicaid managed care plan. Whether potential enrollees 
within the service area are enrolled in another Medicaid managed care 
plan or QHP is not relevant.
    Communication from the Medicaid managed care plan to its current 
enrollees is not within the definition of marketing in Sec.  
438.104(a); the definition is clear that marketing is communication to 
a Medicaid beneficiary who is not enrolled in that plan. Communications 
to the managed care plan's current enrollees, however, are subject to 
Sec.  438.10.
    Comment: We received a few comments suggesting that CMS require 
that plans that develop marketing materials for specific populations, 
ethnicities, and cultures be required to produce those materials in the 
prevalent non-English languages in that state.
    Response: While this suggestion may make marketing materials more 
effective, we decline to add it as a requirement in Sec.  438.104. In 
proposed Sec.  438.10(d)(4), we did specify that written materials that 
are critical to obtaining services must be translated into the 
prevalent non-English languages in the state. We do not believe 
marketing materials are critical to obtaining services.
    Comment: A few commenters recommended that the state must review 
marketing materials as proposed in Sec.  438.104(c) for accuracy of 
information, language, reading level, comprehensibility, cultural 
sensitivity and diversity; to ensure that the managed care plan does 
not target or avoid populations based on their perceived health status, 
disability, cost, or for other discriminatory reasons; and that 
materials are not misleading for a person not possessing special 
knowledge regarding health care coverage.
    Response: We agree with the suggestions offered by these commenters 
for state review of marketing materials. However, we believe accuracy 
of information, language, reading level, comprehensibility, cultural 
sensitivity and diversity, and ensuring materials are not misleading 
are already addressed in Sec.  438.104 (b)(1)(iii) and (b)(2); we 
expect that state review of marketing materials will include the full 
scope of standards in the rule and in the state contract. In 
considering the commenters' concern that managed care plans may target 
or avoid populations based on their perceived health status, cost, or 
for other discriminatory reasons, we remind commenters that all 
contracts must comply with Sec.  438.3(f)(1) regarding anti-
discrimination laws and regulations. Section 438.104 (b)(1)(ii) adds an 
additional protection by requiring that managed care plans distribute 
marketing materials to their entire service area, thus lessening the 
ability to target certain populations. We decline to revise Sec.  
438.104 in response to these comments.
    Comment: Some commenters suggested that CMS permit flexibility for 
states to determine which materials should be subject to review in 
proposed Sec.  438.104(c), particularly when using social media 
outlets. A few commenters also requested flexibility on the use of the 
Medical Care Advisory Committee as referenced in proposed Sec.  
438.104(c). We received one comment suggesting that any materials being 
sent to enrollees, including those from a QHP, be reviewed and approved 
by the state.
    Response: We do not agree that states should have flexibility to 
identify which marketing materials they must review. Section 
1932(d)(2)(A)(i)(I) of the Act requires state approval of marketing 
materials of MCOs and PCCMs, before distribution. Likewise, section 
1932 (d)(2)(A)(ii) of the Act requires consultation with a Medical Care 
Advisory Committee by the state in the

[[Page 27505]]

process of reviewing and approving such materials. We believe these 
provisions are clear about the requirements for MCOs and PCCMs and we 
have extended those requirements to PIHPs and PAHPs; we do not see a 
basis for adopting different rules for PIHPs and PAHPs in connection 
with state review.
    Comment: We also received one comment that managed care plans may 
be unclear about what they can do to coordinate benefits across 
Medicaid managed care and MA lines of business for individuals who are 
dually eligible without it being categorized as marketing.
    Response: It is unclear how activities performed for coordination 
of benefits would be confused with marketing activities, given that the 
purpose of these two types of activities is completely unrelated. The 
commenter should consult with their state for clarification.
    Comment: We received one comment that requested that CMS allow 
managed care plans to conduct marketing activities during the QHP open 
enrollment period.
    Response: We want to clarify that the provisions of proposed Sec.  
438.104 do not specify times of the year when managed care plans are 
permitted or prohibited from conduct marketing activities. Managed care 
plans are allowed to market consistent with state approval.
    Comment: We received a few comments requesting that CMS permit 
agents, brokers, and providers to conduct marketing activities for 
managed care plans.
    Response: Section 438.104(a) provides that MCO, PIHP, PAHP, PCCM or 
PCCM entity includes any of the entity's employees, network providers, 
agents, or contractors. As such, any person or entity that meets this 
definition is subject to the provisions of Sec.  438.104 and may only 
conduct marketing activities on behalf of the plan consistent with the 
requirements of Sec.  438.104, including state approval.
    After consideration of the public comments, we are adopting these 
provisions as proposed with the revision to the definition of marketing 
materials to include PCCM entities, as discussed above.
b. Appeals and Grievances (Sec. Sec.  438.228, 438.400, 438.402, 
438,404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.424, 431.200, 
431.220 and 431.244)
    We proposed several modifications to the current regulations 
governing the grievance and appeals system for Medicaid managed care to 
further align and increase uniformity between rules for Medicaid 
managed care and rules for MA managed care, private health insurance, 
and group health plans. As we noted in the preamble to the proposed 
rule, the existing differences between the rules applicable to Medicaid 
managed care and the various rules applicable to MA, private insurance, 
and group health plans concerning grievance and appeals processes 
inhibit the efficiencies that could be gained with a streamlined 
grievance and appeals process that applies across markets. A 
streamlined process would make navigating the appeals system more 
manageable for consumers who may move between coverage sources as their 
circumstances change. Our proposed changes in subpart F of part 438 
would adopt new definitions, update appeal timeframes, and align 
certain processes for appeals and grievances. We also proposed 
modifying Sec. Sec.  431.200, 431.220 and 431.244 to complement the 
changes proposed to subpart F of part 438.
    We are concerned that the different appeal and grievance processes 
for the respective programs and health coverage causes: (1) Confusion 
for beneficiaries who are transitioning between private health care 
coverage or MA coverage and Medicaid managed care; and (2) 
inefficiencies for health insurance issuers that participate in both 
the public and private sectors. We proposed to better align appeal and 
grievance procedures across these areas to provide consumers with a 
more manageable and consumer friendly appeals process and allow health 
insurers to adopt more consistent protocols across product lines.
    The grievance, organization determination, and appeal regulations 
in 42 CFR part 422, subpart M, govern grievance, organization 
determinations, and appeals procedures for MA members. The internal 
claims and appeals, and external review processes for private insurance 
and group health plans are found in 45 CFR 147.136. We referred to both 
sets of standards in reviewing current Medicaid managed care 
regulations regarding appeals and grievances. (1) Sec. Sec.  431.200, 
431.220, 431.244, subpart F, part 438, and Sec.  438.228.
    Two of our proposals concerning the grievance and appeals system 
for Medicaid managed care were for the entire subpart. First, we 
proposed to add PAHPs to the types of entities subject to the standards 
of subpart F and proposed to revise text throughout this subpart 
accordingly. Currently, subpart F only applies to MCOs and PIHPs. 
Unlike MCOs which provide comprehensive benefits, PIHPs and PAHPs 
provide a narrower benefit package. While PIHPs were included in the 
standards for a grievance system in the 2002 rule, PAHPs were excluded. 
At that time, most PAHPs were, in actuality, capitated PCCM programs 
managed by individual physicians or small group practices and, 
therefore, were not expected to have the administrative structure to 
support a grievance process. However, since then, PAHPs have evolved 
into arrangements under which entities--private companies or government 
subdivisions--manage a subset of Medicaid covered services such as 
dental, behavioral health, and home and community-based services. 
Because some PAHPs provide those medical services which typically are 
subject to medical management techniques such as prior authorization, 
we believe PAHPs should be expected to manage a grievance process, and 
therefore, proposed that they be subject to the grievance and appeals 
standards of this subpart. In adding PAHPs to subpart F, our proposal 
would also change the current process under which enrollees in a PAHP 
may seek a state fair hearing immediately following an action to deny, 
terminate, suspend, or reduce Medicaid covered services, or the denial 
of an enrollee's request to dispute a financial liability, in favor of 
having the PAHP conduct the first level of review of such actions. We 
relied on our authority at sections 1902(a)(3) and 1902(a)(4) of the 
Act to propose extending these appeal and grievance provisions to 
PAHPs.
    We note that some PAHPs receive a capitated payment to provide only 
NEMT services to Medicaid beneficiaries; for these NEMT PAHPs, an 
internal grievance and appeal system does not seem appropriate. The 
reasons for requiring PAHPs that cover medical services to adhere to 
the grievance and appeals processes in this subpart are not present for 
a PAHP solely responsible for NEMT. We proposed to distinguish NEMT 
PAHPs from PAHPs providing medical services covered under the state 
plan. Consequently, we proposed that NEMT PAHPs would not be subject to 
these internal grievance and appeal standards. Rather, beneficiaries 
receiving services from NEMT PAHPs will continue to have direct access 
to the state fair hearing process to appeal adverse benefit 
determinations, as outlined in Sec.  431.220. We requested comment on 
this approach.
    As a result of our proposal to have PAHPs generally follow the 
provisions of subpart F of part 438, we also proposed corresponding 
amendments to Sec. Sec.  431.220 and 431.244 regarding state fair 
hearing requirements, and changes

[[Page 27506]]

to Sec.  431.244 regarding hearing decisions. In Sec.  431.220(a)(5), 
we proposed to add PAHP enrollees to the list of enrollees that have 
access to a state fair hearing after an appeal has been decided in a 
manner adverse to the enrollee; and in Sec.  431.220(a)(6), we proposed 
that beneficiaries receiving services from NEMT PAHPs would continue to 
have direct access to the state fair hearing process. We proposed no 
additional changes to Sec.  431.220. In Sec.  431.244, as in part 438 
subpart F generally, in each instance where MCO or PIHP is referenced, 
we proposed to add a reference to PAHPs.
    Second, throughout subpart F, we proposed to insert ``calendar'' 
before any reference to ``day'' to remove any ambiguity as to the 
duration of timeframes. This approach is consistent with the timeframes 
specified in regulations for the MA program at 42 CFR part 422, subpart 
M.
    We did not propose any changes to Sec.  438.228 but received 
comments that require discussion of that provision in this final rule. 
We received the following comments in response to our proposals.
    Comment: Many commenters supported CMS' proposal to insert 
``calendar'' before ``day'' to remove ambiguity as to the duration of 
timeframes throughout subpart F. Many commenters also supported the CMS 
proposal to add PAHPs to the types of entities subject to the standards 
of subpart F of this part. A few commenters recommended that CMS add 
NEMT PAHPs to the types of entities subject to the standards, while a 
few commenters agreed with the CMS proposal to exclude NEMT PAHPs and 
allow beneficiaries receiving services from NEMT PAHPs to continue to 
have direct access to the state fair hearing process.
    Response: We thank commenters for their support regarding our 
proposal to insert ``calendar'' before ``day'' to remove ambiguity as 
to the duration of timeframes throughout subpart F. We also thank the 
commenters who supported our proposal to make non-NEMT PAHPs subject to 
the appeal and grievance system requirements in subpart F. For adding 
NEMT PAHPs to the types of entities subject to the same standards, we 
restate our position that it seems unreasonable and inappropriate for 
such entities to maintain an internal grievance and appeal system, as 
these entities only receive a capitated payment to provide NEMT. We 
believe that it is more efficient to allow beneficiaries who receive 
services from NEMT PAHPs to continue to have direct access to the state 
fair hearing process to appeal adverse benefit determinations.
    Comment: A few commenters recommended that CMS allow additional 
time for states and managed care plans to establish and implement their 
grievance and appeal systems to comply with the requirements for 
subpart F of this part. One commenter recommended that CMS give states 
and managed care plans 6 months to come into compliance with subpart F 
of this part. One commenter recommended that CMS give states and 
managed care plans 18 months to come into compliance with subpart F of 
this part, as the new requirements are so extensive.
    Response: We appreciate the commenters' recommendations on how much 
time CMS should allow for states and managed care plans to come into 
compliance with subpart F of this part. We believe that the changes and 
revisions throughout subpart F of this part are consistent with the 
standards in MA and the private market. We did not propose a separate, 
or longer, compliance timeframe for these revisions to the appeal and 
grievance system and do not believe that additional time is necessary. 
Therefore, we decline to give states and managed care plans an 
additional 6 months or 18 months to specifically come into compliance 
with the standards and requirements in subpart F of this part. 
Contracts starting on or after July 1, 2017, must be compliant with the 
provisions in subpart F.
    After consideration of the public comments, we are finalizing our 
proposal to add PAHPs (other than NEMT PAHPs) to the types of entities 
subject to the standards of subpart F of this part and our proposal to 
insert ``calendar'' before any reference to the ``day'' regarding 
duration of timeframes throughout subpart F of this part.
    Comment: A few commenters recommended that CMS clarify at Sec.  
438.228(a) that appeals are included as part of the state's grievance 
system.
    Response: We agree with commenters that Sec.  438.228(a) should be 
revised to clarify that each managed care plan must have a grievance 
and appeal system that meets the requirements of subpart F of this 
part. We are modifying the regulatory text, as recommended, to 
explicitly address this. We note that commenters recommended this 
change throughout subpart F of this part to clarify that a state's 
grievance system was inclusive of appeals. We have made this change 
throughout subpart F of this part as recommended.
    Comment: A few commenters recommended that CMS revise the term 
``action'' to ``adverse benefit determination'' at Sec.  438.228(b) to 
be consistent with subpart F of this part.
    Response: We clarify for commenters that Sec.  438.228(b) refers to 
the ``action'' specified under subpart E of part 431. It would not be 
appropriate to revise the term ``action,'' as this term is used in 
subpart E of part 431 and was not proposed to be changed. However, 
during our review of these public comments, we identified a needed 
revision in Sec.  431.200 to update the terminology from ``takes 
action'' to ``adverse benefit determination'' when referring to subpart 
F of part 438 of this chapter. We have revised the term ``action'' to 
``adverse benefit determination'' in subpart F of part 438 and revised 
the phrase ``takes action'' to ``adverse benefit determination'' in 
Sec.  431.200 when referring to subpart F of part 438 of this chapter.
    Comment: A few commenters recommended that CMS revise the language 
``dispose'' and ``disposition'' to ``resolve'' and ``resolution'' 
throughout subpart F of this part to be consistent when referring to 
the final resolution of an adverse benefit determination.
    Response: We agree with commenters that the terms ``dispose'' and 
``disposition'' should be revised to ``resolve'' and ``resolution'' to 
be consistent throughout subpart F of this part when referring to the 
final resolution of an adverse benefit determination. We are modifying 
the regulatory text accordingly in this final rule.
    After consideration of the public comments, we are modifying the 
regulatory text at Sec.  438.228(a) to include the term ``appeal'' when 
referencing the grievance system and to be inclusive of both grievances 
and appeals. Since commenters recommended this change throughout 
subpart F of this part, we have made this change accordingly as 
recommended. We are also replacing the terms ``dispose'' and 
``disposition'' with ``resolve'' and ``resolution'' in connection with 
an appeal and grievance throughout our finalization of subpart F of 
this part when referring to the final resolution of an adverse benefit 
determination; this ensures that the phrasing for appeals and 
grievances is consistent. Finally, we are modifying Sec.  431.200 to 
update the terminology from ``takes action'' to ``adverse benefit 
determination'' when referring to subpart F of part 438 of this 
chapter.
(2) Statutory Basis and Definitions (Sec.  438.400)
    In general, the proposed changes for Sec.  438.400 are to revise 
the definitions to provide greater clarity and to achieve alignment and 
uniformity for health

[[Page 27507]]

care coverage offered through Medicaid managed care, private insurance 
and group health plans, and MA plans. We did not propose to change the 
substance of the description of the authority and applicable statutes 
in Sec.  438.400(a) but proposed a more concise statement of the 
statutory authority.
    In Sec.  438.400(b), we proposed a few changes to the defined 
terms. First, we proposed to replace the term ``action'' with ``adverse 
benefit determination.'' The proposed definition for ``adverse benefit 
determination'' included the existing definition of ``action'' and 
revisions to include determinations based on medical necessity, 
appropriateness, health care setting, or effectiveness of a covered 
benefit in revised paragraph (b)(1). We believed this would conform to 
the term used for private insurance and group health plans and would 
lay the foundation for MCOs, PIHPs, or PAHPs to consolidate processes 
across Medicaid and private health care coverage sectors. By adopting a 
uniform term for MCO, PIHP, or PAHP enrollees and enrollees in private 
insurance and group health plans, we hoped to enable consumers to 
identify similar processes between lines of business, and be better 
able to navigate different health care coverage options more easily. 
Our proposal was also to update cross-references to other affected 
regulations, delete the term ``Medicaid'' before the word ``enrollee,'' 
and consistently replace the term ``action'' in the current regulations 
in subpart F with the term ``adverse benefit determination'' throughout 
this subpart.
    In addition to using the new term ``adverse benefit 
determination,'' we proposed to revise the definition of ``appeal'' to 
be more accurate in describing an appeal as a review by the MCO, PIHP, 
or PAHP, as opposed to the current definition which defines it as a 
request for a review. In the definition of ``grievance,'' we proposed a 
conforming change to delete the reference to ``action,'' to delete the 
part of the existing definition that references the term being used to 
mean an overall system, and to add text to clarify the scope of 
grievances.
    For clarity, we proposed to separately define ``grievance system'' 
as the processes the MCO, PIHP, or PAHP implements to handle appeals 
and grievances and collect and track information about them. By 
proposing a definition for ``grievance system,'' we intended to clarify 
that a MCO, PIHP, or PAHP must have a formal structure of policies and 
procedures to appropriately address both appeals and grievances. We 
also proposed to remove the reference to the state's fair hearing 
process from this definition as it is addressed in part 431, subpart E. 
This continued to be a significant source of confusion, even after the 
changes were made in the 2002 final rule, and these proposed changes 
were intended to add clarity.
    We received the following comments in response to our proposal to 
revise Sec.  438.400.
    Comment: A few commenters requested that CMS clarify the statutory 
authority at Sec.  438.400(a) regarding changes to the grievance and 
appeal system in general, as well as the statutory authority to align 
timeframes with MA and/or the private market.
    Response: We appreciate the opportunity to clarify the statutory 
authority summarized at Sec.  438.400(a). As noted in the authority for 
part 438 generally, section 1102 of the Act provides authority for CMS 
to adopt rules to interpret, implement, and administer the Medicaid 
program. Section 1902(a)(3) of the Act requires that a state plan 
provide an opportunity for a fair hearing to any person whose claim for 
assistance is denied or not acted upon promptly. Section 1932(b)(4) of 
the Act is the statutory authority that requires MCOs to offer an 
internal grievance and appeal system. Subpart F, as a whole and as 
finalized in this rule, implements these requirements and sets 
standards for how a Medicaid program complies with these when an MCO is 
used to provide Medicaid covered services to beneficiaries. Section 
1902(a)(4) of the Act requires that the state plan provide for methods 
of administration that the Secretary finds necessary for the proper and 
efficient operation of the plan and is the basis for extending the 
internal grievance and appeal system to PIHPs and PAHPs. We also rely 
on section 1902(a)(4) of the Act to align grievance and appeal 
timeframes with either MA and/or the private market to build 
efficiencies both inside Medicaid, including for managed care plans, 
and across public and private programs.
    Comment: Many commenters recommended changes to the definition of 
``adverse benefit determination'' at Sec.  438.400(b). Several 
commenters stated that the CMS proposal to change and expand the 
definition from ``action'' to ``adverse benefit determination'' will 
create confusion for enrollees and result in additional administrative 
burden and costs to managed care plans and states to change existing 
policies and materials. Several commenters stated that the definition 
is not broad enough and should be expanded to include more options for 
enrollees to request an appeal. Several commenters supported the 
proposed definition and applauded the effort to align the definition 
across health care markets. Several commenters specifically recommended 
that CMS revise the definition of ``adverse benefit determination'' to 
include disputes regarding an enrollee's financial liability, such as 
deductibles, copayments, coinsurance, premiums, health spending 
accounts, out-of-pocket costs, and/or other enrollee cost sharing. A 
few commenters also recommended that CMS revise the definition of 
``adverse benefit determination'' to include disputes regarding an 
enrollee's request to receive services outside of the managed care 
plan's network or an enrollee's choice of provider.
    Response: We appreciate the opportunity to consider commenters' 
recommendations regarding the definition of ``adverse benefit 
determination'' at Sec.  438.400(b). We disagree with commenters who 
believed the change from ``action'' to ``adverse benefit 
determination'' will be confusing to enrollees, as the term ``adverse 
benefit determination'' is the standard terminology used throughout the 
health care industry. We favor aligning terms across health care 
markets and programs as much as possible to support enrollees who may 
transition across health care coverage options.
    We agree with commenters that the definition should be broadened to 
include potential enrollee financial liability, as we recognize that 
state Medicaid programs have some discretion regarding cost sharing and 
there can be variations in financial requirements on enrollees. We are 
modifying the regulatory text to adopt this recommendation.
    For broadening the definition to include disputes regarding an 
enrollee's request to receive services outside of the managed care 
plan's network or an enrollee's choice of provider, we do not believe 
it is necessary to include this specifically in the definition of 
``adverse benefit determination.'' Section 438.206(b)(4), as proposed 
and as we would finalize, requires that managed care plans adequately 
and timely cover services outside of the network when the managed care 
plan's network is unable to provide such services; the definition 
already includes the denial or limited authorization for a service and 
the denial of payment for a service, which we believe adequately 
includes a denial of a request to receive covered services from an out-
of-network provider. The proposed definition also contains a provision 
for enrollees of rural areas with only one MCO to exercise their right 
to obtain services

[[Page 27508]]

outside of the managed care plan's network consistent with Sec.  
438.52(b)(2)(ii). We believe that broadening the definition of 
``adverse benefit determination'' to include additional language 
specific to out-of-network services would be duplicative.
    Comment: Many commenters recommended that CMS specifically define 
``medical necessity,'' ``appropriateness,'' ``health care setting,'' 
``effectiveness,'' and ``denial of payment for a service'' used within 
the definition of ``adverse benefit determination.'' A few commenters 
also recommended that CMS remove references to ``health care setting'' 
or revise the language to ``setting'' within the definition of 
``adverse benefit determination'' to be more inclusive of MLTSS 
programs and populations.
    Response: We appreciate the recommendations about the terms used in 
the definition for an ``adverse benefit determination.'' We disagree 
with commenters that we need to define the terms ``medical necessity,'' 
``appropriateness,'' ``health care setting,'' ``effectiveness,'' and 
``denial of payment for a service'' within that definition. We believe 
it is inappropriate for CMS to define these terms at the federal level 
when states need to define these terms when establishing and 
implementing their grievance and appeal system and procedures for their 
respective programs. That said, we do agree with commenters that the 
term ``health care setting'' may not be inclusive of MLTSS programs and 
populations; therefore, we will finalize the definition to use the term 
``setting'' only.
    Comment: A few commenters disagreed with the CMS proposal to revise 
the term ``appeal'' at Sec.  438.400(b) and instead recommended that 
CMS retain the original language ``a request for a review.'' Commenters 
stated that the current definition of ``appeal'' does not include any 
action by the enrollee.
    Response: In the preamble of the proposed rule (80 FR 31104), we 
described the deletion of the phrase ``request for review'' in terms of 
accuracy. We proposed to revise the definition of ``appeal'' to add 
accuracy by stating that an appeal is a review by the MCO, PIHP, or 
PAHP, as opposed to the current definition, which defines it as a 
request for a review. This revision is consistent with MA and the 
private market. In light of these public comments and to add clarity to 
the regulation text, we will add the term ``request'' throughout 
subpart F of part 438 when referring to ``filing'' an appeal. We will 
retain the proposed language for ``filing'' a grievance. Specifically, 
we will make this change in Sec. Sec.  438.402(c)(1)(i) and (ii), 
438.402(c)(2)(i) and (ii), 438.402(c)(3)(i) and (ii), 438.404(b)(3), 
438.404(c)(4)(i), and 438.408(c)(2)(ii). We believe this change will 
add accuracy to the regulation text as commenters requested. We will 
retain and finalize the definition of ``appeal'' as proposed.
    Comment: Several commenters recommended that CMS clarify why the 
definition of ``grievance system'' at Sec.  438.400(b) includes 
appeals, but the definition of ``grievance'' is not the same as an 
``appeal.'' Commenters stated concern that enrollees might be confused 
by the inconsistency in the language. A few commenters also recommended 
that CMS retitle subpart F of this part to include appeals.
    Response: We agree with commenters that clarification is needed to 
ensure consistency throughout subpart F of this part. Therefore, we 
agree with commenters that subpart F of this part should be retitled 
``Grievance and Appeal System'' to be inclusive of both grievances and 
appeals. We note that the longstanding title of subpart F was based on 
section 1932(b)(4) of the Act. We also agree with commenters that the 
definition ``grievance system'' should be revised to ``grievance and 
appeal system'' to be inclusive of both grievances and appeals. We are 
modifying the regulatory text in the definitions in Sec.  438.400 and 
throughout subpart F to adopt these recommendations.
    After consideration of the public comments, we are finalizing Sec.  
438.400 as proposed with several modifications. In the final definition 
of ``adverse benefit determination'' in Sec.  438.400(b), we are adding 
to the proposed text a new category that addresses potential enrollee 
financial liability; we are also modifying the definition to replace 
the term ``health care setting'' with ``setting'' to be inclusive of 
MLTSS programs and populations.
    We are also modifying the regulatory text to retitle subpart F of 
this part as ``Grievance and Appeal System'' to be inclusive of both 
grievances and appeals and revising the term ``grievance system,'' 
defined in Sec.  438.400(b) and throughout subpart F of part 438, to 
``grievance and appeal system'' to be inclusive of both grievances and 
appeals. We are also modifying the regulation text to add the term 
``request'' throughout subpart F of part 438 when referring to 
``filing'' an appeal to improve clarity and accuracy. We are finalizing 
all other provisions in Sec.  438.400 as proposed.
(3) General Requirements (Sec.  438.402)
    We proposed in paragraph (a) to add ``grievance'' in front of 
``system'' and to delete existing language that defines a system in 
deference to the proposed new definition added in Sec.  438.400. We 
also proposed to add text to clarify that subpart F does not apply to 
NEMT PAHPs.
    In paragraph (b), we proposed to revise the paragraph heading to 
``Level of appeals'' and limit MCOs, PIHP, and PAHPs to only one level 
of appeal for enrollees to exhaust the managed care plan's internal 
appeal process. Once this single level appeal process is exhausted, the 
enrollee would be able to request a state fair hearing under subpart E 
of part 431. In conjunction with this proposal, we proposed amending 
Sec.  438.402(c)(1)(i) and Sec.  438.408(f) with corresponding text 
that would have enrollees exhaust their MCO, PIHP, or PAHP appeal 
rights before seeking a state fair hearing. Our proposal was designed 
to ensure that the MCO, PIHP, or PAHP process will not be unnecessarily 
extended by having more than one level of internal review. This 
proposal was consistent with the limit on internal appeal levels 
imposed on issuers of individual market insurance under 45 CFR 
147.136(b)(3)(ii)(G) and MA organizations at Sec.  422.578, although we 
acknowledge that issuers of group market insurance and group health 
plans are not similarly limited under 45 CFR 147.136(b)(2) and 29 CFR 
2560.503-1(c)(3). We believed this proposal would not impair the 
administrative alignment we seek in this context and ensure that 
enrollees can reach the state fair hearing process within an 
appropriate time. We requested comment on this proposal.
    In paragraph (c)(1)(i), we proposed to revise this section to 
permit an enrollee to request a state fair hearing after receiving 
notice from the MCO, PIHP, or PAHP upholding the adverse benefit 
determination. We proposed in paragraph (c)(1)(ii) to remove the 
standard for the enrollee's written consent for the provider to file an 
appeal on an enrollee's behalf. The current standard is not specified 
in section 1932(b)(4) of the Act and is inconsistent with similar MA 
standards for who may request an organization determination or a 
reconsideration at Sec. Sec.  422.566(c)(1)(ii) and 422.578, so we 
believe it is not necessary.
    We proposed in paragraph (c)(2) to delete the state's option to 
select a timeframe between 20 and 90 days for enrollees to file a 
request for an appeal and proposed to revise paragraphs (c)(2)(i) and 
(ii) to set the timing

[[Page 27509]]

standards for filing grievances (at any time) and requesting appeals 
(60 calendar days), respectively. For grievances, we do not believe 
that grievances need a filing limit as they do not progress to a state 
fair hearing and thus do not need to be constrained by the coordination 
of timeframes. For appeals, we proposed paragraph (c)(2)(ii) to permit 
an enrollee or provider to request an appeal within 60 calendar days of 
receipt of the notice of an adverse benefit determination. Medicare 
beneficiaries in a MA plan and enrollees in private health care 
coverage each have 60 calendar days to request an appeal under 
regulations governing MA plans (Sec.  422.582) and private insurance 
and group health plans (45 CFR 147.136(b)(2) and (b)(3) and 29 CFR 
2560.503-1(h)(2)). By adjusting the timeframe for MCO, PIHP, or PAHP 
enrollees to request appeals to 60 calendar days from the date of 
notice of the adverse decision, our proposal would achieve alignment 
and uniformity across Medicaid managed care plans, MA organizations, 
and private insurance and group health plans, while ensuring adequate 
opportunity for beneficiaries to appeal. We note that the existing 
provisions of Sec.  438.402(b)(2)(i) were subsumed into our proposal 
for paragraphs (c)(1)(i) and (ii) while the existing provisions of 
paragraph (b)(2)(ii) would be deleted consistent with our proposal in 
Sec.  438.408(f)(1) concerning exhaustion of the MCO's, PIHP's, or 
PAHP's appeal process.
    In paragraph (c)(3), we proposed to add headings to paragraphs 
(c)(3)(i) and (c)(3)(ii) and to make non-substantive changes to the 
text setting forth the procedures by which grievances are filed or 
appeals are requested. Under our proposal, as under current law, a 
standard grievance may be filed or an appeal may be requested orally or 
in writing (which includes online), and standard appeal requests made 
orally must be followed up in writing by either the enrollee or the 
enrollee's authorized representative. Expedited appeal requests may be 
requested either way, and if done orally, the enrollee does not need to 
follow up in writing.
    We requested comment on the extent to which states and managed care 
plans are currently using or plan to implement an online system that 
can be accessed by enrollees for filing and/or status updates of 
grievances and appeals. If such systems are not in use or in 
development, we requested comment on the issues influencing the 
decision not to implement such a system and whether an online system 
for tracking the status of grievances and appeals should be required at 
the managed care plan level.
    We received the following comments in response to our proposal to 
revise Sec.  438.402.
    Comment: Many commenters supported proposed Sec.  438.402(b) which 
limits each MCO, PIHP, and PAHP to only one level of appeal for 
enrollees. Many commenters supported the goals of alignment, 
administrative simplification, and efficiency for both managed care 
plans and enrollees. Many commenters also disagreed with our proposal 
to limit managed care plans to one level of appeal and offered a number 
of recommendations. These commenters recommended that CMS allow two 
levels of appeal for managed care plans, as a second level of appeal at 
the managed care plan can generally resolve the issue before proceeding 
to state fair hearing. Several commenters recommended that CMS allow 
states to define this process, as states have procedures in place 
today.
    Response: We thank commenters for their thoughtful comments 
regarding proposed Sec.  438.402(b). We agree with the comments that 
limiting managed care plans to one level of appeal is both efficient 
and beneficial to enrollees; such a limitation allows enrollees to 
receive a more expedient resolution to their appeal and minimizes 
confusion for enrollees during the appeals process. Aligning with the 
requirements of MA and the private market will promote administrative 
simplicity. We disagree with commenters that recommended that states be 
allowed to decide whether to limit Medicaid managed care plans to one 
level of appeal or not based on their state-specific program. We 
believe it is beneficial to create a national approach that aligns with 
other health care coverage options and will allow enrollees to 
transition across public and private health care programs with similar 
requirements. This consistency will aid enrollees in understanding the 
benefits of the appeal process and how to effectively utilize it 
regardless of which type of coverage they have.
    Comment: Many commenters disagreed and offered alternative 
proposals regarding proposed Sec.  438.402(c)(1)(i), which requires 
enrollees to exhaust the one level of appeal at the managed care plan 
before requesting a state fair hearing. Many commenters recommended 
that CMS continue to allow direct access or concurrent access to the 
state fair hearing, as this is a critical beneficiary protection, 
especially for vulnerable populations with complex, chronic, and 
special health care needs. Commenters stated that vulnerable 
populations might be easily overburdened by the additional process and 
have health care needs that require an immediate review by an 
independent and impartial authority to prevent any further delays or 
barriers to care. Many commenters recommended that CMS allow state 
flexibility to ensure that current beneficiary protections in place 
today are not unnecessarily eroded. A few commenters stated that some 
states currently allow the state fair hearing in place of the managed 
care plan appeal and recommended that CMS retain this as an option.
    Several commenters also recommended that CMS allow for an optional 
and independent external medical review, which is independent of both 
the state and the managed care plan. Commenters stated that such an 
optional external review can better protect beneficiaries and reduce 
burden on state fair hearings, as these external processes have proven 
to be an effective tool in resolving appeals before reaching a state 
fair hearing. Several commenters also recommended that CMS adopt the 
deemed exhaustion requirement from the private market rules at 45 CFR 
147.136(b)(2)(ii)(F) to ensure that enrollees maintain access to a 
state fair hearing if the managed care plan does not adhere to the 
notice and timing requirements in Sec.  438.408, including specific 
timeframes for resolving standard and expedited appeals. Finally, a few 
commenters supported the provision as proposed without change and 
stated that it builds a better relationship between enrollees and their 
managed care plans.
    Response: We appreciate the many thoughtful and specific 
recommendations regarding proposed Sec.  438.402(c)(1)(i) and recognize 
the need to carefully consider the impact of the exhaustion requirement 
on enrollees. While we understand commenters' concerns and 
recommendations regarding direct access to a state fair hearing for 
vulnerable populations, we also have concerns regarding inconsistent 
and unstructured processes. We believe that a nationally consistent and 
uniform appeals process (particularly one consistent with how other 
health benefit coverage works) benefits enrollees and will better lead 
to an expedited resolution of their appeal. As we proposed, this final 
rule shortens the managed care plan resolution timeframe for standard 
appeals from 45 days to 30 calendar days and shortens the managed care 
plan resolution timeframe for expedited appeals from 3 working days to 
72 hours; we believe this will address concerns about the length of 
time an enrollee must wait

[[Page 27510]]

before accessing a state fair hearing. This final rule also lengthens 
the timeframe for enrollees to request a state fair hearing from a 
maximum of 90 days to 120 calendar days. We have aligned these 
timeframes with other public and private health care markets and 
believe this ultimately protects enrollees by establishing a national 
approach for a uniform appeals process. Therefore, CMS is not allowing 
direct access or concurrent access to the state fair hearing in this 
rule.
    We also agree with commenters that adopting the deemed exhaustion 
requirement from the private market rules at 45 CFR 
147.136(b)(2)(ii)(F) will ensure that enrollees maintain access to a 
state fair hearing if the managed care plan does not adhere to the 
notice and timing requirements in Sec.  438.408, including specific 
timeframes for resolving standard and expedited appeals. In addition, 
this will further align the rules for the grievance and appeal system 
for Medicaid managed care plans with the system for private health 
insurance; we note as well that Medicare Advantage plans are subject to 
a somewhat similar standard under Sec.  422.590(c) and (g) in that 
failure of a Medicare Advantage plan to resolve timely a 
reconsideration of an appeal decision results in the appeal being 
forwarded automatically to the next level of review. We also note that 
states would be permitted to add rules that deem exhaustion on a 
broader basis than this final rule. We are modifying the final text of 
Sec.  438.402(c) and 438.408(f) to adopt the recommendation to add a 
deemed exhaustion requirement.
    While we disagree with commenters that recommended that states be 
allowed to establish their own processes and timeframes for grievances 
and appeals that differ from the requirements of the proposed rule, we 
are persuaded by commenters' recommendations regarding an optional and 
independent external medical review. We agree with commenters that an 
optional, external medical review could better protect enrollees and be 
an effective tool in resolving appeals before reaching a state fair 
hearing. Under the rule we are finalizing here, if states want to offer 
enrollees the option of an external medical review, the review must be 
at the enrollee's option and must not be a requirement before or used 
as a deterrent to proceeding to the state fair hearing. Further, if 
states want to offer enrollees the option of an external medical 
review, the review must be independent of both the state and managed 
care plan, and the review must be offered without any cost to the 
enrollee. Finally, this final rule requires that any optional external 
medical review must not extend any of the timeframes specified in Sec.  
438.408 and must not disrupt the continuation of benefits in Sec.  
438.420. Accordingly, the regulation text in this final rule at 
Sec. Sec.  438.402(c)(1)(i)(B) and 438.408(f)(ii) adopts this 
recommendation.
    Comment: Many commenters were opposed to the proposal in Sec.  
438.402(c)(1)(ii) to remove the requirement for the provider to obtain 
the enrollee's written consent before acting on the enrollee's behalf 
in requesting an appeal. Commenters stated that enrollees have the 
right to know and give their consent before a provider acts on their 
behalf. Commenters also stated concerns regarding potential conflicts 
of interest or potential fraud, waste, and abuse if the enrollee does 
not know that a provider is requesting an appeal on their behalf. Other 
commenters stated concern that without the enrollee's written consent, 
this could result in duplicative appeals from both providers and 
enrollees. A few commenters noted that because enrollees can be held 
financially liable for services received during an appeal, enrollees 
should be informed and give their explicit written consent before a 
provider requests an appeal on their behalf. A few commenters supported 
the proposed provision and stated that obtaining the enrollee's written 
consent is an unnecessary barrier to requesting the appeal. A few 
commenters also recommended that CMS remove the state's discretion in 
recognizing and permitting the provider to act as the enrollee's 
authorized representative. Several commenters also recommended that CMS 
expand the list of authorized representatives who can request appeals 
and grievances and request state fair hearings on the enrollee's behalf 
to include legal representatives, attorneys, enrollee advocates, legal 
guardians, and other representatives authorized by the enrollee to act 
on their behalf.
    Response: We appreciate the many comments and recommendations 
regarding proposed Sec.  438.402(c)(1)(ii). Given the volume of 
comments and potential issues raised by commenters, we were persuaded 
to modify our proposal and recognize the benefit of requiring a 
provider to obtain an enrollee's written consent before requesting an 
appeal on their behalf. We were particularly persuaded by commenters 
who noted that because enrollees can be held financially liable for 
services received during an appeal, enrollees should give their 
explicit written consent before a provider requests an appeal on their 
behalf. Therefore, we will finalize the regulatory text to require that 
providers obtain the enrollee's written consent before requesting the 
appeal, consistent with the current rule.
    However, we disagree with commenters regarding the recommendation 
to remove the state's discretion to recognize the provider as an 
authorized representative of the enrollee; we believe the state should 
be permitted to make this decision when designing and implementing 
their grievance and appeal system. We note as well that the ability of 
a provider to act as an authorized representative of an enrollee could 
vary based on state law. We also did not accept commenters' 
recommendation to explicitly expand our list of authorized 
representatives. Although, in principle, we agree that legal 
representatives, beneficiary advocates, and similar parties may 
effectively serve as authorized representatives, we defer to state 
determinations regarding the design of their grievance and appeal 
system; state laws could vary regarding who the state recognizes as an 
authorized representative. Nothing in Sec.  438.402(c)(1)(ii) would 
prohibit a legally authorized representative from acting on the 
enrollee's behalf in requesting an appeal, as long as the state 
recognizes and permits such legally authorized representative to do so. 
However, in response to these comments, we will clarify that when the 
term ``enrollee'' is used throughout subpart F of this part, it 
includes providers and authorized representatives consistent with this 
paragraph, with the exception that providers cannot request 
continuation of benefits as specified in Sec.  438.420(b)(5). This 
exception applies because an enrollee may be held liable for payment 
for those continued services, as specified in Sec.  438.420(d), and we 
believe it is critical that the enrollee--or an authorized 
representative who is not a provider--initiate the request.
    Comment: A few commenters recommended that CMS add a separate 
appeals process for providers to dispute the denial of payment for 
services rendered.
    Response: We disagree with commenters that a separate appeals 
process should be added to accommodate providers who are disputing the 
denial of payment for services rendered. We believe that managed care 
plans already have internal processes and procedures for providers who 
are disputing the denial of payment for services under the

[[Page 27511]]

contract between the provider and the managed care plan. In addition, 
the only appeals process dictated by statute in section 1932(b)(4) of 
the Act involves an enrollee's challenge to the denial of coverage for 
medical assistance. We encourage providers to work with managed care 
plans to address any potential concerns or issues.
    Comment: Several commenters recommended that CMS cap the timeframe 
for enrollees to submit a grievance at Sec.  438.402(c)(2)(i). 
Commenters recommended a number of specific timeframes, including 30 
calendar days, 60 calendar days, 90 calendar days, 120 calendar days, 
180 calendar days, and 1 year. Commenters stated that without a 
timeframe to submit grievances, enrollees will be confused about how 
long they have to file a grievance, and managed care plans will expend 
additional resources to track down and revisit grievance issues that 
occurred in the past.
    Response: We appreciate commenters' concerns regarding this issue; 
however, we decline to add a timeframe cap that requires enrollees to 
file a grievance within a specific amount of time. As we previously 
noted in the proposed rule, grievances do not progress to the level of 
a state fair hearing; therefore, we find it unnecessary to include 
filing limits or constrain grievances to the coordination of 
timeframes. We understand that managed care plans may be concerned 
about revisiting grievance issues that occurred in the past, but we 
believe this is a normal part of doing business and that enrollees 
should be permitted to file a grievance at any time.
    Comment: Many commenters supported proposed Sec.  
438.402(c)(2)(ii), which requires enrollees to request an appeal within 
60 calendar days of an adverse benefit determination. Commenters stated 
that alignment in this area will create administrative efficiencies and 
be easier for enrollees transitioning across health care coverage 
options. Several commenters disagreed with the proposal and recommended 
that CMS align with the rules governing QHPs (45 CFR 147.136(b)(2)(i) 
and(3)(i), incorporating 29 CFR 2560.503-1(h)(3)(i)) to allow enrollees 
180 days to request an appeal. Other commenters recommended alternative 
timeframes, including 10 calendar days, 30 calendar days, 90 calendar 
days, and 120 calendar days. Several commenters recommended that CMS 
clarify the language regarding ``following receipt of a notification.'' 
Commenters stated concern that states, managed care plans, and 
enrollees will be confused regarding the actual date the 60 calendar 
day clock starts, as it is hard to know when enrollees will receive the 
notice.
    Response: We thank commenters for their support and recommendations 
regarding proposed Sec.  438.402(c)(2)(ii). We agree with commenters 
that alignment in this area will create administrative efficiencies and 
be easier for enrollees transitioning across health care coverage 
options. We note that the preamble in the proposed rule (80 FR 31104) 
contained inaccurate information regarding the 60-day appeal filing 
limit for QHPs and group health plans. QHPs and group health plans have 
a 180 calendar day filing limit for appeals under 45 CFR 
147.136(b)(2)(i) and (3)(i) (incorporating 29 CFR 2560.503-1(h)(3)(i)). 
However, we believe that our proposal should align with MA and use the 
filing limit for appeals at 60 calendar days. In this final rule, we 
allow 60 calendar days for enrollees to file the appeal with the 
managed care plan, and upon notice that the managed care plan is 
upholding their adverse benefit determination, the enrollee has an 
additional 120 calendar days to file for state fair hearing. We believe 
it is important for enrollees to file appeals as expediently as 
possible. We are therefore finalizing our proposal to keep the appeal 
filing deadline for the plan level appeal at 60 calendar days. This 
approach strikes the appropriate balance between aligning with other 
coverage sources while taking into account the specific features of the 
Medicaid program. Finally, we agree with commenters that the proposed 
language ``following receipt of a notification'' is ambiguous as to 
when the 60 calendar day clock starts. We clarify that the 60 calendar 
day appeal filing limit begins from the date on the adverse benefit 
determination notice. We note that it is our expectation that managed 
care plans mail out the notices on the same day that the notices are 
dated. We are finalizing the rule with modified regulatory text to 
adopt this recommendation.
    Comment: Several commenters recommended that CMS revise Sec.  
438.402(c)(3)(ii) to remove the requirement for enrollees or providers 
to follow-up an oral standard appeal with a written and signed appeal. 
Commenters stated that this requirement adds an unnecessary barrier to 
enrollees filing an appeal with the managed care plan. A few commenters 
stated that this requirement is confusing, as it is ambiguous from 
which date (the date of the oral request or of the written request) the 
resolution timeframe applies. One commenter recommended that CMS 
include language at Sec.  438.402(c)(3)(ii) to require that managed 
care plans close all oral appeals within 10 calendar days, if they have 
not received the follow-up written and signed appeal.
    Response: We understand commenters' concerns regarding the 
requirement to follow-up an oral standard appeal with a written and 
signed appeal; however, we believe that this requirement is necessary 
to ensure appropriate and accurate documentation. Consistent with Sec.  
438.406(b)(3), we clarify that the resolution timeframe begins from the 
date of the oral appeal. We also clarify that the requirement to 
follow-up with a written and signed appeal does not apply to oral 
expedited appeals. The resolution timeframe would begin from the date 
the oral expedited appeal is received by the managed care plan and no 
further written or signed appeal is required. We also disagree with the 
commenter that recommended that all oral appeals be closed within 10 
calendar days if no written or signed follow-up is received. This is 
not consistent with our general approach to allow enrollees to submit 
appeals orally and in writing. Managed care plans should treat oral 
appeals in the same manner as written appeals.
    Comment: Many commenters provided recommendations and feedback 
regarding the preamble discussion in the proposed rule (80 FR 31104) 
related to online grievance and appeal systems. Several commenters 
stated that such a system would be onerous on both enrollees and 
managed care plans, as many enrollees may not have internet access 
readily available and many managed care plans will have budgetary 
concerns in implementing such a system. Many commenters also stated 
concerns over the potential for privacy breaches and the extra 
resources that managed care plans and states would have to deploy to 
protect and secure such systems. Some commenters were highly supportive 
of such systems and recommended that CMS make online grievance and 
appeal systems a requirement on managed care plans. Several commenters 
also recommended alternative approaches, such as enrollee and provider 
portals.
    Response: We appreciate all of the comments related to online 
grievance and appeal systems. At this time, we have decided to not move 
forward with a requirement for managed care plans to implement such a 
system. We encourage states and managed care plans to think more about 
this concept and engage the stakeholder community regarding the pros 
and cons of implementing an online grievance and appeal system. We 
agree with certain commenters that

[[Page 27512]]

there may be tangible benefits for enrollees, but we also understand 
other commenters' concerns regarding both costs and privacy.
    Comment: A few commenters recommended that CMS require states and 
managed care plans to monitor the volume of appeals and grievances from 
enrollees. One commenter recommended that CMS set specific quantitative 
thresholds and benchmarks for states and managed care plans to follow. 
The commenter also recommended that CMS set specific penalties and 
sanctions for states and managed care plans with a volume of appeals 
and grievances that exceeds the quantitative threshold or benchmark.
    Response: States are required to address the performance of their 
appeal and grievance systems in the managed care program assessment 
report required at Sec.  438.66. We disagree with commenters that we 
should set a specific quantitative threshold or benchmark regarding the 
number of appeals and grievances, as we believe that this would vary 
greatly depending on the size and scope of the managed care program, 
the populations served, and the service area of each managed care plan. 
States are responsible for monitoring appeals and grievances within 
their respective programs.
    After consideration of the public comments, we are finalizing the 
regulatory text at Sec.  438.402 with some modifications from the 
proposal as discussed above. Specifically, we are finalizing Sec.  
438.402(c)(1)(i) with a deemed exhaustion requirement, similar to the 
requirement in 45 CFR 147.136(b)(2)(ii)(F), to ensure that enrollees 
maintain access to a state fair hearing if the managed care plan does 
not adhere to the notice and timing requirements in Sec.  438.408. We 
are also finalizing the regulatory text at Sec.  438.402(c)(1)(i) with 
modifications to permit states to offer an optional and independent 
external medical review within certain parameters; the external review 
must be at the enrollee's option, it must not be a requirement before 
or used as a deterrent to proceeding to the state fair hearing, it must 
be offered without any cost to the enrollee, it must not extend any of 
the timeframes specified in Sec.  438.408, and must not disrupt the 
continuation of benefits in Sec.  438.420. We are finalizing a 
modification to the regulatory text at Sec.  438.402(c)(1)(ii) to 
require that providers obtain the enrollee's written consent before 
filing an appeal and to clarify that when the term ``enrollee'' is used 
throughout subpart F of this part, it includes providers and authorized 
representatives, with the exception that providers cannot request 
continuation of benefits as specified in Sec.  438.420(b)(5). As 
explained above, this exception applies because an enrollee may be held 
liable for payment for those continued services, as specified in Sec.  
438.420(d), and we believe it is critical that the enrollee--or an 
authorized representative of the enrollee who is not a provider--
initiate the request. Finally, we are finalizing the regulatory text at 
Sec.  438.402(c)(2)(ii) with a modification to clarify that the 60 
calendar day appeal filing limit begins from the date on the adverse 
benefit determination notice. We are finalizing all other provisions in 
Sec.  438.402 as proposed.
(4) Timely and Adequate Notice of Adverse Benefit Determination (Sec.  
438.404)
    In Sec.  438.404, we proposed to revise the section heading to a 
more accurate and descriptive title, ``Timely and adequate notice of 
adverse benefit determination.'' In paragraph (a), we proposed a non-
substantive wording revision to more accurately reflect the intent that 
notices must be timely and meet the information requirements detailed 
in proposed Sec.  438.10.
    In paragraph (b), describing the minimum content of the notice, we 
proposed to delete paragraph (b)(4) (about the state option to require 
exhaustion of plan level appeal processes) to correspond to our 
proposal in Sec.  438.408(f) and redesignate the remaining paragraphs 
accordingly. In paragraph (b)(2), we proposed to clarify that the 
reason for the adverse benefit determination includes the right of the 
enrollee to be provided upon request and free of charge, reasonable 
access to and copies of all documents, records, and other information 
relevant to the enrollee's adverse benefit determination. This 
additional documentation would include information regarding medical 
necessity criteria, consistent with Sec.  438.210(a)(5)(i) as 
appropriate, and any processes, strategies, or evidentiary standards 
used in setting coverage limits. In new paragraph (b)(5), we proposed 
to replace expedited ``resolution'' with expedited ``appeal process'' 
to add consistency with wording throughout this subpart. We further 
proposed to add the phrase ``consistent with State policy'' in 
paragraph (b)(6) to be consistent with a proposed change in Sec.  
438.420(d) regarding the MCO's, PIHP's, or PAHP's ability to recoup 
from the enrollee under a final adverse decision be addressed in the 
contract and that such practices be consistent across both FFS and 
managed care delivery systems within the state. While notice of the 
possibility of recoupment under a final adverse decision is an 
important beneficiary protection, we noted that such notice may deter 
an enrollee from exercising the right to appeal. We indicated that we 
would issue guidance following publication of the rule regarding the 
model language and content of such notice to avoid dissuading enrollees 
from pursuing appeals.
    In paragraph (c), we proposed to revise paragraph (c)(4) to replace 
``extends the timeframe in accordance with . . .'' with ``meets the 
criteria set forth . . .'' to more clearly state that MCOs, PIHPs, and 
PAHPs cannot extend the timeframes without meeting the specific 
standards of Sec.  438.210(d)(1)(ii). Lastly, in paragraph (c)(6), we 
proposed to update the cross reference from Sec.  438.210(d) to Sec.  
438.210(d)(2).
    We received the following comments in response to our proposal to 
revise Sec.  438.404.
    Comment: Several commenters broadly supported the proposed 
requirements in Sec.  438.404. A few commenters recommended adding 
specific language at Sec.  438.404(a) to reference the language and 
format requirements at Sec.  438.10(d), specifically, Sec.  
438.10(d)(3) and (4). One commenter also recommended that CMS define 
``timely'' at Sec.  438.404(a).
    Response: We thank commenters for their broad support of proposed 
Sec.  438.404. The language at Sec.  438.404(a) requires that managed 
care plans give enrollees timely and adequate notice of adverse benefit 
determination in writing consistent with the requirements in Sec.  
438.10 generally; therefore, we find the recommendation to specifically 
add references for Sec.  438.10(d)(3) and (4) duplicative and 
unnecessary. We also decline to define ``timely'' at Sec.  438.404(a), 
as the requirements for timing of notices are found at Sec.  
438.404(c)(1) through (c)(6).
    Comment: Several commenters recommended revisions to Sec.  
438.404(b)(2). A few commenters recommended that CMS require managed 
care plans to specifically explain their medical necessity criteria. 
One commenter recommended that CMS require managed care plans to 
specifically explain how their medical necessity criteria is the same 
for physical health, mental health, and substance use disorders. One 
commenter recommended that CMS revise language at (b)(2) to specify 
that all ``documents and records are relevant to the specific enrollee 
appeal.'' One commenter recommended that CMS add

[[Page 27513]]

``policies and procedures'' to the language at (b)(2). A few commenters 
recommended that CMS define ``reasonable access'' and ``relevant.'' 
Finally, a few commenters recommended that CMS clarify that providers 
and authorized representatives can request access to all of the same 
information and documentation specified at (b)(2).
    Response: We understand commenters' concerns regarding medical 
necessity criteria; however, it is unclear what specific requirements 
should be imposed on managed care plans to ``explain'' their medical 
necessity criteria. We have included requirements at (b)(2) for managed 
care plans to disclose their medical necessity criteria regarding any 
adverse benefit determination and believe this to be sufficient. 
Because the adverse benefit determination notice must include the 
reasons for the determination, to the extent that the denial is based 
on a lack of medical necessity, the regulation requires that managed 
care plans explain the medical necessity criteria applied, consistent 
with Sec.  438.210(a)(5)(i) as appropriate, under the managed care 
plan's policies. Therefore, we are not adopting this recommendation.
    We also decline commenters' recommendations to add (``documents and 
records are relevant to the specific enrollee appeal'' and ``policies 
and procedures'') or define (``reasonable access'' and ``relevant'') 
terms. We find this language duplicative and unnecessary. In addition, 
we believe the standard at (b)(2) is clear that managed care plans must 
disclose all documents, records, and other information relevant to the 
enrollee's adverse benefit determination. We are not familiar with any 
existing federal standard for ``reasonable access'' or ``relevant'' 
that we can draw upon in this context. We believe that these terms are 
adequately defined and understood in common discourse. We encourage 
commenters to work with states and managed care plans when specific 
issues arise regarding an enrollee's ``reasonable access'' to 
documentation, or the ``relevance'' of such documentation. Finally, we 
restate that state laws could vary regarding who the state recognizes 
as an authorized representative. Nothing in Sec.  438.404(b)(2) would 
prohibit an authorized representative (including a provider who is 
acting on behalf of an enrollee) from requesting the same information 
and documentation specified at (b)(2), as long as the state recognizes 
and permits such legally authorized representative to do so.
    Comment: Several commenters recommended that CMS include additional 
requirements at Sec.  438.404(b)(3) to include information on 
exhausting the one level of managed care plan appeal and enrollees' 
rights to request a state fair hearing at Sec.  438.402(b) and (c).
    Response: We agree with commenters that it is important for 
enrollees to understand the totality of the grievance and appeal 
process. It would improve transparency and provide enrollees clear 
information if Sec.  438.404(b)(3) specified that the notice must 
include the enrollee's and provider's right to request an appeal of the 
managed care plan's adverse benefit determination and include 
information on exhausting the one level of managed care plan appeal and 
enrollees' rights to request a state fair hearing at Sec.  438.402(b) 
and (c). We are modifying the regulatory text to adopt this 
recommendation accordingly.
    Comment: Several commenters recommended that CMS correct a 
typographical error at Sec.  438.404(b)(6) to correct ``right to have 
benefits continue pending resolution . . .''
    Response: We thank commenters for catching this typographical 
error, and we are modifying the regulatory text accordingly.
    Comment: A few commenters provided additional recommendations for 
CMS to implement at Sec.  438.404 generally. One commenter recommended 
that CMS require Medicaid managed care plans to use the same notice 
templates already adopted in the MA context. One commenter recommended 
that CMS remove all notice requirements, as such requirements are 
administratively burdensome on managed care plans.
    Response: One of the goals of the proposed rule was alignment 
across public and private health care coverage markets; however, we do 
not believe it feasible to require Medicaid managed care plans to use 
the MA notice templates given the different nature and administrative 
structures of the programs. We have attempted to ensure that many of 
the notice requirements are similar across both MA and Medicaid. We 
also decline to remove all notice requirements. While we understand the 
commenter's concern regarding managed care plan burden, we believe this 
is a normal part of doing business in the health care market and that 
notices provide important protections for beneficiaries.
    After consideration of the public comments, we are finalizing the 
regulation text at Sec.  438.404 as proposed with two modifications. We 
are finalizing additional regulatory text at Sec.  438.404(b)(3) to 
specify that the notice must include the enrollee's and provider's 
right to request an appeal of the managed care plan's adverse benefit 
determination and include information on exhausting the one level of 
managed care plan appeal and enrollees' rights to request a state fair 
hearing at Sec.  438.402(b) and (c). We are also modifying the 
regulatory text at Sec.  438.404(b)(2) to make a technical correction 
and Sec.  438.404(b)(6) to correct a typographical error. We are 
finalizing all other sections as proposed.
(5) Handling of Grievances and Appeals (Sec.  438.406)
    In addition to language consistent with our overall proposal to 
make PAHPs subject to the grievance and appeals standards for MCOs and 
PIHPs, we proposed to reorganize Sec.  438.406 to be simpler and easier 
to follow and to revise certain procedural standards for appeals. 
Existing paragraph (a) was proposed to be revised by adding the 
existing provision in paragraph (a)(1) to paragraph (a), which 
specifies that each MCO, PIHP, and PAHP must give enrollees any 
reasonable assistance, including auxiliary aids and services upon 
request, in completing forms and taking other procedural steps. In 
paragraph (b), we proposed to revise the paragraph heading and 
redesignate existing provisions in paragraphs (a)(2) and (a)(3) as 
(b)(1) and (b)(2), respectively; we also proposed to add grievances to 
the provisions of both. MCOs, PIHPs, or PAHPs would have to send an 
acknowledgment receipt for each appeal and grievance and follow the 
limitations on individuals making decisions on grievances and appeals 
in paragraphs (b)(2)(i) and (ii). In new paragraph (b)(2)(i), we 
proposed to add that individuals who are subordinates of individuals 
involved in any previous level of review are, like the individuals who 
were involved in any previous level of review, excluded from making 
decisions on the grievance or appeal. This final proposed revision 
added assurance of independence that we believe is appropriate and is 
consistent with standards under the private market rules in 45 CFR 
147.136 that incorporate 29 CFR 2560.503-1(h)(3)(ii). Redesignated 
paragraph (b)(2)(ii) was proposed to remain unchanged from its current 
form. Consistent with the standards under the private market rules in 
45 CFR 147.136 that incorporate 29 CFR 2560.503-1(h)(2)(iv), we 
proposed to add a new paragraph (b)(2)(iii) to specify that individuals 
that make decisions on appeals and grievances take all comments, 
documents, records, and other information submitted by the

[[Page 27514]]

enrollee into account regardless of whether the information had been 
considered in the initial review. We also proposed to redesignate 
current paragraph (b)(2) as (b)(4) and add ``testimony'' in addition to 
evidence and legal and factual arguments. We also proposed to use the 
phrase ``legal and factual arguments'' to replace the phrase 
``allegations of fact or law'' in the current text for greater clarity.
    We noted that current paragraph (b)(3) required the enrollee to 
have the opportunity before and during the appeal process to examine 
the case file, medical record and any documents or records considered 
during the appeal process. We proposed to redesignate this paragraph as 
paragraph (b)(5) and to replace ``before and during'' with 
``sufficiently in advance of the resolution'', to add specificity. We 
also proposed to add ``new or additional evidence'' to the list of 
information and documents that must be available to the enrollee. The 
proposed language in paragraph (b)(5) would more closely align with the 
disclosure standards applicable to private insurance and group health 
plans in 45 CFR 147.136(b)(2)(ii)(C)(1). Existing paragraph (b)(4) was 
proposed to be redesignated as paragraph (b)(6) without change.
    We received the following comments in response to our proposal to 
revise Sec.  438.406.
    Comment: Many commenters broadly supported the revised Sec.  
438.406 that we proposed. A few commenters recommended that CMS add 
references in Sec.  438.406(a) to include that each MCO, PIHP, and PAHP 
must comply with the requirements in Sec.  438.10(d)(3) and (4).
    Response: We decline to add cross-references in Sec.  438.406(a) to 
Sec.  438.10(d)(3) and (4), as we find such text to be duplicative and 
unnecessary. Managed care plans must comply with all of the 
requirements in Sec.  438.10, and we included the appropriate 
references in Sec.  438.404 regarding notices.
    Comment: Many commenters recommended that CMS clarify at Sec.  
438.406(b)(1) how managed care plans should acknowledge the receipt of 
each grievance and appeal. Several commenters recommended that CMS add 
timeframe requirements to Sec.  438.406(b)(1), with a few commenters 
specifically recommending 3 calendar days for managed care plans to 
acknowledge receipt of each grievance and appeal.
    Response: We appreciate commenters' recommendations but believe 
that it is not necessary to set such detailed requirements in the 
regulation. We believe that such details are better set forth in the 
contracts between states and managed care plans. We encourage managed 
care plans to provide written acknowledgment of the receipt of each 
grievance and appeal as soon as possible to ensure that enrollees 
receive timely and accurate information.
    Comment: Several commenters recommended that CMS remove the 
language at Sec.  438.406(b)(2)(i) in regard to managed care plans 
ensuring that individuals who make decisions on grievances and appeals 
are individuals who were neither involved in any previous level of 
review or decision-making, nor a subordinate of any such individual. A 
few commenters found this language to be confusing and requested that 
CMS clarify the requirement. One commenter recommended that CMS define 
the meaning of ``subordinate.'' A few commenters recommended that CMS 
allow state flexibility on this issue, as states can better negotiate 
such requirements with managed care plans. One commenter stated that 
such a requirement would add administrative costs and burden on managed 
care plans, as the language requires managed care plans to conduct 
multiple levels of review with multiple individuals from separate 
departments.
    Response: We appreciate the opportunity to clarify the requirement 
at Sec.  438.406(b)(2)(i). We believe that this requirement is 
important, as it adds an additional level of beneficiary protection and 
is consistent with standards in the private market. It is not only 
reasonable but consistent with the concept of the appeal as a fair and 
impartial review of the underlying facts and situation that individuals 
reviewing and making decisions on grievances and appeals are not the 
same individuals, nor subordinates of individuals, who made the 
original adverse benefit determination; it seems unlikely that an 
individual would bring the necessary impartiality and open-mindedness 
when reviewing his or her own prior decision and analysis. Similarly, a 
subordinate may have concerns or hesitation with challenging or 
overruling a determination made by his or her supervisor that are 
unrelated to the specific facts and policies for an appeal We disagree 
with commenters that this language should be removed.
    We decline to define explicitly the term ``subordinate,'' in the 
regulation as we believe it is clear that in this context, subordinates 
are individuals who report to or are supervised by the individuals who 
made the original adverse benefit determination. We also decline to 
allow states to enforce a different standard, as we believe this 
standard is clear and should serve as a national benchmark for handling 
grievances and appeals and that states have discretion within their 
standard to develop particular approaches with their plans. Finally, 
while we understand the commenter's concern regarding managed care plan 
burden, we believe this is a normal part of doing business in the 
health care market. We further clarify that Sec.  438.406(b)(2)(i) does 
not require multiple levels of review from separate departments. The 
standard requires that individuals reviewing and making decisions about 
grievances and appeals are not the same individuals, nor subordinates 
of individuals, who made the original adverse benefit determination. 
Reviewers hearing an appeal of an adverse benefit determination may be 
from the same department (or a different department) so long as the 
necessary clinical expertise and independence standards are met and the 
reviewer takes into account the information described in Sec.  
438.406(b)(2)(iii).
    Comment: Several commenters recommended that CMS add more 
specificity at Sec.  438.406(b)(2)(ii) regarding the health care 
professionals who have the appropriate clinical expertise in treating 
the enrollee's condition or disease. A few commenters recommended that 
CMS revise the language to specify that health care professionals must 
be licensed to specifically treat the enrollee's condition or disease. 
A few commenters recommended that CMS add language for pediatric 
specialists and expertise in treating pediatric patients. Some 
commenters also recommended that CMS revise the language to 
specifically add that health care professionals must have clinical 
expertise in treating the enrollee's specific condition and disease.
    Response: We understand commenters' concerns regarding the 
appropriate clinical expertise of the individuals making decisions on 
grievances and appeals; however, we decline to adopt these specific 
recommendations. The language at Sec.  438.406(b)(2)(ii) specifies that 
individuals should have the appropriate clinical expertise as 
determined by the state. Depending on the scope of the program, the 
populations served, and the specific services or benefits in question, 
we believe this could vary greatly from appeal to appeal. We believe, 
as the current text requires, that states are in the best position to 
make these decisions about their respective programs. States are also 
in the best position to monitor a managed care

[[Page 27515]]

plan's appeals and grievances and make the necessary changes as 
appropriate when unsatisfactory patterns emerge. We note that states 
are required to address the performance of their appeal and grievance 
systems in the managed care program assessment report required at Sec.  
438.66. As discussed in section I.B.9.a. of this final rule, ``health 
care professional'' has been changed to ``individual'' in Sec.  
438.406(b)(2)(ii).
    Comment: Many commenters recommended that CMS define at Sec.  
438.406(b)(4) ``reasonable opportunity'' and ``sufficiently in 
advance'' in regard to an enrollee's right to present evidence and 
testimony and make legal and factual arguments. One commenter 
recommended that CMS remove the language ``make legal and factual 
arguments'' as enrollees are only able to make allegations of fact or 
law.
    Response: We appreciate the commenters' recommendations to add more 
specificity at Sec.  438.406(b)(4) but decline to do so, as we believe 
such specificity could have unintended consequences. We believe it 
would be operationally difficult for CMS to specify an exact timeframe 
for when a managed plan should allow an enrollee to present evidence 
and testimony. We also believe that under certain circumstances, such 
as in the case of an expedited appeal or an extension of the standard 
resolution timeframe, it would be difficult to apply an exact standard 
across all grievances and appeals. We encourage managed care plans to 
work with enrollees or an enrollee's representative to allow as much 
time as possible for enrollees to present evidence and testimony. We 
also encourage managed care plans to inform enrollees of this 
opportunity as soon as feasible to improve transparency during the 
process. We also encourage states to think about how they might set 
such standards with their managed care plans. We also disagree with the 
commenter's recommendation to remove the language ``make legal and 
factual arguments'' as we believe this language adds more clarity than 
``allegations of fact or law.'' We believe that enrollees have the 
right to make legal and factual arguments and defend their position to 
individuals who are making decisions on the outcomes of grievances and 
appeals, who will ultimately decide the validity of such legal and 
factual arguments.
    Comment: Several commenters recommended specific revisions to Sec.  
438.406(b)(5). A few commenters recommended that CMS add language to 
clarify that providers can also access this same information. One 
commenter recommended that CMS add ``or otherwise relevant'' to the 
regulatory text in regard to additional evidence. A few commenters 
recommended that CMS clarify that such information is only available 
upon request. One commenter disagreed with CMS and recommended the 
removal of the language ``new or additional evidence . . . generated by 
the MCO, PIHP, or PAHP'' as the commenter stated it is not appropriate 
for managed care plans to allow access to information or documents that 
were generated internally. A few commenters recommended that CMS 
clarify that the documents and information available at Sec.  
438.404(b)(2) are the same documents and information available at Sec.  
438.406(b)(5). Finally, one commenter recommended regulatory text 
changes to remove the phrase in parentheses and recommended the 
creation of a new sentence.
    Response: We appreciate the many thoughtful recommendations 
regarding Sec.  438.406(b)(5). We do not believe it is necessary to 
specifically add ``providers'' as we believe it is clear that ``his or 
her representative'' can include a provider. We reiterate that state 
laws could vary regarding who the state recognizes as an authorized 
representative. Nothing in Sec.  438.406(b)(5) would prohibit an 
authorized representative from requesting the same information and 
documentation specified at (b)(5), as long as the state recognizes and 
permits such legally authorized representative to do so. We also 
disagree with the commenter's recommendation to add ``or otherwise 
relevant'' to the regulatory text in regard to additional evidence. We 
believe the current text is clear that any new or additional evidence 
considered, relied upon, or generated by the MCO, PIHP, or PAHP in 
connection with the appeal of the adverse benefit determination should 
be made available for review. We also disagree that such information is 
only available upon request, as this standard does not exist in 
regulation today.
    We disagree with the commenter's recommendation to remove the 
language ``new or additional evidence . . . generated by the MCO, PIHP, 
or PAHP'' as we believe it is necessary and appropriate for managed 
care plans to make this information available to enrollees and their 
representatives to ensure a fair and impartial appeal. We clarify that 
the documents and information referenced at Sec.  438.404(b)(2) and 
Sec.  438.406(b)(5) are similar; however, it is possible that the 
enrollee's case file used for the appeal at Sec.  438.406(b)(5) could 
contain additional documents and information that were not available at 
the time of the adverse benefit determination under Sec.  
438.404(b)(2). We agree with the commenter's recommendation to 
restructure the sentence to remove the parentheses. We are modifying 
the regulatory text to adopt this recommendation accordingly.
    After consideration of the public comments, we are finalizing Sec.  
438.406 with a modification at Sec.  438.406(b)(5) to restructure the 
sentence and remove the parentheses. We are also finalizing Sec.  
438.406(b)(2)(i), as discussed more fully in section I.B.9.a. of this 
final rule, to replace the term ``health care professional'' with 
``individual.'' Finally, we are modifying Sec.  438.406(a) to add the 
language ``related to a grievance or appeal'' to improve the accuracy 
of the sentence. We are finalizing all other sections as proposed.
(6) Resolution and Notification: Grievances and Appeals (Sec. Sec.  
438.408 and 431.244(f))
    We proposed to make significant modifications to Sec.  438.408 to 
further align Medicaid managed care standards with MA and private 
insurance and group health plan standards. We proposed several 
significant modifications as explained in more detail below: (1) 
Changes in the timeframes to decide appeals and expedited appeals; (2) 
strengthen notice standards for extensions; and (3) change the 
processes for receiving a state fair hearing for enrollees of MCOs, 
PIHPs, and PAHPs. In addition, we proposed to reorganize the regulation 
for greater clarity and to add the phrase ``consistent with state 
policy'' to paragraph (e)(2)(iii) to be consistent with our proposal in 
Sec.  438.420(d).
    In Sec.  438.408(b)(2), we proposed to adjust the timeframes in 
which MCOs, PIHPs, and PAHPs would have to make a decision about an 
enrollee appeal to align with the standards applicable to a MA 
organization. Currently, MCOs and PIHPs may have up to 45 days to make 
a decision about a standard (non-expedited) appeal. In Sec.  
422.564(e), MA plans must make a decision about first level appeals in 
30 days, while Part D plans must provide a decision in 7 days under 
Sec.  423.590(a)(1). Federal regulations on the private market permit 
up to 60 days for a standard decision on an internal appeal (see Sec.  
147.136(b)(2)(i) and (b)(3), incorporating 29 CFR 2560.503-1(b)(1) for 
individual health insurance issuers and group health insurance issuers 
and plans). We proposed to shorten the timeframe for MCO, PIHP, and 
PAHP appeal decisions from 45 days to 30 calendar days, which would 
achieve alignment with MA

[[Page 27516]]

standards while still allowing adequate time for decision-making and 
response.
    In paragraph (b)(3), we proposed to adjust the Medicaid managed 
care timeframes for expedited appeals to align with standards 
applicable to MA and the private market. Currently under subpart F, 
MCOs and PIHPs have 3 working days from receipt of a request to make a 
decision in an expedited review. The MA (Sec.  422.572(a)) and private 
market regulations (29 CFR 2590.715-2719(c)(2)(xiii)) stipulate that a 
plan must make a decision within 72 hours of receiving a request for 
expedited review. We proposed to modify our expedited appeal decision 
timeframes from 3 working days to 72 hours. The change would improve 
the speed with which enrollees would receive a MCO, PIHP, or PAHP 
decision on critical issues, and align Medicaid managed care with 
Medicare and private insurance and group health plans.
    For extensions of the timeframe to resolve an appeal or grievance 
when the enrollee has not requested the extension (Sec.  
438.408(c)(2)), we proposed to strengthen the notification 
responsibilities on the MCO, PIHP, or PAHP by setting new specific 
standards and to add existing text in Sec.  438.408(c) to paragraph 
(c)(2). We proposed to add the current standards in Sec.  
438.404(c)(4)(i) and (ii) to Sec.  438.408(c)(ii) and (iii), which 
describe the standards on the MCO, PIHP, or PAHP for an extension of 
the timeframe for standard or expedited appeals for clarity and 
consistency.
    In Sec.  438.408(d)(1) and (2), we proposed to add a provision 
requiring that grievance notices (as established by the state) and 
appeal notices (as directed in the regulation) from a MCO, PIHP, or 
PAHP ensure meaningful access for people with disabilities and people 
with limited English proficiency by, at a minimum, meeting the 
standards described at Sec.  438.10.
    In Sec.  438.408(e), we proposed to add ``consistent with state 
policy'' in paragraph (e)(2)(iii) to be clear that such practices must 
be consistent across both FFS and managed care delivery systems within 
the state. This is added here to be consistent with a proposed change 
in Sec.  438.420(d) that stipulates that the MCO's, PIHP's, or PAHP's 
ability to recoup from the enrollee under a final adverse decision must 
be addressed in the contract and that such practices be consistent 
across both FFS and managed care delivery systems within the state. For 
example, if the state does not exercise the authority for recoupment 
under Sec.  431.230(b) for FFS, the same practice must be followed by 
the state's contracted MCOs, PIHPs, and PAHPs.
    In Sec.  438.408(f), we proposed to modify the Medicaid managed 
care appeals process such that an enrollee must exhaust the MCO, PIHP, 
or PAHP appeal process prior to requesting a state fair hearing. This 
would eliminate a bifurcated appeals process while aligning with MA and 
the private market regulations. Under current Medicaid rules, states 
have the discretion to decide if enrollees must complete the MCO, PIHP, 
or PAHP appeal process before requesting a state fair hearing or 
whether they can request a state fair hearing while the MCO, PIHP, or 
PAHP appeal process is still underway. Depending on the state's 
decision in this regard, this discretion has led to duplicate efforts 
by the MCO, PIHP, or PAHP and the state to address an enrollee's 
appeal. Both MA rules and regulations governing private market and 
group health plans have a member complete the plan's internal appeal 
process before seeking a second review. Our proposed change would be 
consistent with both those processes.
    Specifically, under the proposed change in paragraph (f)(1), a MCO, 
PIHP, or PAHP enrollee would have to complete the MCO, PIHP, or PAHP 
appeal process before requesting a state fair hearing. The proposed 
change would enable consumers to take advantage of the state fair 
hearing process in a consecutive manner which would lead to less 
confusion and effort on the enrollee's part and less administrative 
burden on the part of the managed care plan and the state; the use of a 
federal standard for this would eliminate variations across the country 
and lead to administrative efficiencies for the MCOs, PIHPs, and PAHPs 
that operate in multiple states. Moreover, our proposed reduction in 
the timeframes that a MCO, PIHP, or PAHP would have to take action on 
an appeal (from 45 to 30 calendar days) in Sec.  438.408(b)(2) would 
permit enrollees to reach the state fair hearing process more quickly. 
We believed that our proposal would achieve the appropriate balance 
between alignment, beneficiary protections, and administrative 
simplicity.
    We proposed in new paragraph (f)(2) to revise the timeframe for 
enrollees to request a state fair hearing to 120 calendar days. This 
proposal would extend the maximum period under the current rules and 
would give enrollees more time to gather the necessary information, 
seek assistance for the state fair hearing process and make the request 
for a state fair hearing.
    We also proposed a number of changes to Sec.  431.244, Hearing 
Decisions, that correspond to these proposed amendments to Sec.  
438.408. In Sec.  431.244, we proposed to remove paragraph (f)(1)(ii) 
which references direct access to a state fair hearing when permitted 
by the state. As that option is proposed to be deleted in Sec.  
438.408(f)(1), it should also be deleted in Sec.  431.244(f)(1). In 
Sec.  431.244(f)(2), we considered whether to modify the 3 working day 
timeframe on the state to conduct an expedited state fair hearing. In 
the interest of alignment, we examined the independent and external 
review timeframes in both MA and QHPs and found no analogous standard 
or consistency for final administrative action regarding expedited 
hearings. We therefore proposed to keep the state fair hearing 
expedited timeframe at 3 working days. We proposed to delete current 
paragraph (f)(3) as it is no longer relevant given the deletion of 
direct access to state fair hearing proposed revision to Sec.  
438.408(f)(1). We proposed no additional changes to Sec.  431.244.
    We received the following comments in response to our proposal to 
revise Sec.  438.408 and Sec.  431.244.
    Comment: Many commenters supported the proposed revisions to Sec.  
438.408 and recommended specific revisions throughout the section. A 
few commenters recommended that CMS remove the 90 calendar day 
requirement to resolve grievances at Sec.  438.408(b)(1), as some 
grievances are not resolvable, such as the rudeness of an employee or 
provider. A few commenters also recommended that CMS shorten the 90 
calendar day requirement to 60 calendar days or 30 calendar days to be 
more consistent with the timeframe for appeals at Sec.  438.408(b)(2).
    Response: We disagree with commenters that we should remove the 90 
calendar day requirement to resolve grievances. While the rudeness of 
an employee or provider might be outside of the managed care plan's 
control, the managed care plan can acknowledge the complaint, monitor 
complaints for unsatisfactory patterns, and take action as necessary. 
We also decline to shorten the 90 calendar day requirement, as the 
regulatory text already gives states the flexibility to set a timeframe 
that does not exceed 90 calendar days from the day the MCO, PIHP, or 
PAHP receives the grievance. Grievances are not as urgent as appeals, 
and they do not proceed to the state fair hearing level; therefore, we 
believe a national standard of less than 90 days is not necessary or 
beneficial.
    Comment: Many commenters recommended alternative timeframes at

[[Page 27517]]

Sec.  438.408(b)(2) for the resolution of a standard appeal. A few 
commenters recommended the CMS retain 45 calendar days, while other 
commenters recommended that CMS expand the timeframe to 60 calendar 
days. Several commenters supported the 30 calendar day requirement, and 
one commenter recommended that CMS remove the language that allows 
states to establish a timeframe less than 30 calendar days. A few 
commenters recommended that CMS remove all timeframes and allow 
complete state flexibility on the resolution timeframes for standard 
appeals.
    Response: We disagree with commenters that CMS should retain the 45 
calendar day requirement or expand the timeframe to 60 calendar days. 
We believe that it is important to align with MA in this area to build 
consistency between the two programs, and we believe that 30 calendar 
days allow for the appropriate amount of time that decision makers need 
to evaluate the standard appeal. We also believe that a timeframe of 30 
calendar days will allow enrollees to move to the state fair hearing in 
a more expedient manner, which is an important consideration in light 
of the new exhaustion requirement before a request for a state fair 
hearing can be made. We also disagree with commenters' recommendations 
to remove state flexibility to establish a timeframe that is less than 
30 calendar days, and we disagree with commenters' recommendations that 
states should be allowed greater flexibility to establish all 
resolution timeframes for standard appeals. We believe it is critical 
to strike the appropriate balance among state flexibility, national 
minimum standards, and requirements that align across different health 
care coverage options. In this context, we believe it is appropriate to 
set a national benchmark that standard appeals be resolved for 
enrollees in a set amount of time. If states find that managed care 
plans can resolve standard appeals faster than 30 calendar days, we 
believe that enrollees benefit from providing flexibility for states to 
impose tighter timeframes. We also note that managed care plans will 
have the authority to extend the timeframe beyond 30 calendar days in 
accordance with Sec.  438.408(c) when the specified requirements are 
met.
    Comment: Many commenters recommended alternative timeframes at 
Sec.  438.408(b)(3) for the resolution of an expedited appeal. Some 
commenters recommended that CMS retain the current standard of 3 
working days. Several commenters recommended that CMS revise the 
proposed 72 hour requirement to 24 hours, 1 business day, 2 business 
days, or 3 business days. A few commenters recommended that CMS remove 
the 72 hour requirement in whole and allow states to define the 
standard for their respective programs. One commenter recommended that 
CMS clarify that the 72 hour clock only starts after all medical 
documentation has been received. A few commenters supported the 72 hour 
requirement but recommended special timeframes for specific benefits. 
One commenter recommended a 24 hour requirement for expedited 
prescription appeals to ensure that there is no delay in an enrollee's 
prescription benefit. One commenter recommended a 3 business day 
requirement for all expedited LTSS appeals, as these appeals generally 
have more complex documentation and records. Most commenters that 
recommended alternative timeframes stated concern regarding the 72 hour 
requirement as being too burdensome and costly for managed care plans 
to maintain.
    Response: We appreciate the many comments that we received 
regarding this issue. We believe that 72 hours is the appropriate 
amount of time for Medicaid managed care plans to make a decision on 
expedited appeals, as this timeframe reflects the industry standard for 
expedited appeals and aligns with both MA and the private market. This 
requirement improves the speed at which enrollees receive decisions 
regarding care that may be urgently needed. For these reasons, we are 
adopting it as the national minimum standard for expedited appeals 
across all Medicaid managed care programs. States will retain the 
flexibility to set thresholds earlier than the 72 hour requirement. We 
also decline to add language to the regulatory text to clarify that the 
72 hour clock does not begin until after all medical documentation has 
been received, as in the interest of timely resolution of matters 
affecting enrollee health, we believe that managed care plans should be 
working as expediently as possible to obtain the necessary medical 
documentation to resolve the expedited appeal. We note that managed 
care plans will have the authority to extend the timeframe beyond 72 
hours in accordance with Sec.  438.408(c) when the appropriate and 
specified requirements are met. We also decline to set special 
timeframes for specific benefits, such as pharmacy and LTSS. We believe 
that expedited appeals for these benefits should also follow the 72 
hour requirement. We clarify that some commenters confused expedited 
pharmacy appeals and the 24 hour prior authorization requirement added 
at Sec.  438.3(s)(6) to comply with section 1927(d)(5) of the Act; as 
noted in section I.B.2., the prior authorization process for the 
provision of outpatient covered drugs is not an appeal but is a step 
toward the determination of whether the drug will be covered by the 
managed care plan. We understand commenters' concerns regarding 
administrative burden and costs, but we believe this is similar to the 
requirements in other markets and an expectation of doing business in 
the health care market.
    Comment: Several commenters recommended that CMS revise Sec.  
438.408(c) to remove the 14 calendar day extension for expedited 
appeals. A few commenters also recommended that CMS revise the number 
of calendar days allowed for the extension, as they found 14 calendar 
days to be too long. One commenter recommended that CMS define 
``reasonable efforts'' at Sec.  438.408(c)(2)(i). A few commenters 
recommended that CMS clarify that if the MCO, PIHP, or PAHP extends the 
timeframe, and the extension is not at the request of the enrollee, 
that the managed care plan must cover the cost of all services or 
benefits provided during that 14 calendar day period. A few commenters 
recommended that CMS consider a deemed exhaustion requirement when 
managed care plans fail to meet the timeframe of the extension.
    Response: We disagree with commenters that we should remove the 14 
calendar day extension for standard or expedited appeals. We recognize 
the need for enrollees to expediently move through the appeals process, 
but we believe there are extenuating circumstances that require the 
option of the 14 calendar day extension. Current language at Sec.  
438.408(c)(1)(i) and (ii) allows the enrollee to request the 14 
calendar day extension, or require the managed care plan to demonstrate 
the need for additional information and how the delay will be in the 
enrollee's interest. We believe it is necessary and appropriate to 
continue allowing this option, and we believe that 14 calendar days is 
enough time for both enrollees and managed care plans to gather the 
additional information that is needed to resolve the appeal.
    We decline to define ``reasonable efforts'' at Sec.  
438.408(c)(2)(i) as we do not believe it is necessary. We encourage 
managed care plans to make every effort to reach enrollees and give 
prompt oral notice of the delay. However, we have also required at 
Sec.  438.408(c)(2)(ii) that managed care plans provide enrollees 
written notice of the delay within 2 calendar days. We believe that 
this is

[[Page 27518]]

sufficient action from the managed care plan to ensure that enrollees 
know about any delay of their appeal. We decline to assign, at the 
federal level, the financial liability on the enrollee or the managed 
care plan for services furnished while the appeal is pending, including 
in the context of the 14 calendar day extension. Consistent with the 
notice requirements at Sec. Sec.  438.404(b)(6) and 438.408(e)(2)(iii), 
and the requirements specified at Sec.  438.420(d), enrollees may be 
held responsible or may be required to pay the costs of these services, 
consistent with state policy. Such requirements must be consistently 
applied within the state under both managed care and FFS, as specified 
at Sec.  438.420(d).
    Finally, consistent with our preamble discussion about Sec.  
438.402(c)(1)(i), we agree with commenters that adopting the deemed 
exhaustion requirement from the private market rules at 45 CFR 
147.136(b)(2)(ii)(F) will ensure that enrollees maintain access to a 
state fair hearing if the managed care plan does not adhere to the 
notice and timing requirements in Sec.  438.408, including specific 
timeframes for resolving standard and expedited appeals and the 14 
calendar day extension. We are finalizing the regulatory text to adopt 
this recommendation.
    Comment: A few commenters recommended that CMS clarify that the 
format of the notice at Sec.  438.408(d)(1) and (2) should specifically 
reference the requirements at Sec.  438.10(d).
    Response: The language at Sec.  438.408(d)(1) and (2) require 
managed care plans to format the notice consistent with the 
requirements in Sec.  438.10 generally; therefore, we believe that to 
specifically add references to Sec.  438.10(d) would be duplicative and 
unnecessary.
    Comment: Many commenters disagreed with our proposed exhaustion 
requirement in Sec.  438.408(f)(1) and offered alternatives. Many 
commenters recommended that CMS continue to allow direct access or 
concurrent access to the state fair hearing, as this is a critical 
beneficiary protection, especially for vulnerable populations with 
complex, chronic, and special health care needs that may be 
overburdened by the additional process and require an immediate review 
by an independent and impartial authority to prevent any further delays 
or barriers to care. Many commenters recommended that CMS allow state 
flexibility to ensure that current beneficiary protections in place 
today are not unnecessarily eroded. A few commenters stated that some 
states currently allow the state fair hearing in lieu of the managed 
care plan appeal and recommended that CMS retain this as an option. 
Several commenters also recommended that CMS allow for an optional and 
independent external medical review, which is both outside of the state 
and the managed care plan. Commenters stated that such an optional 
external review can better protect beneficiaries and reduce burden on 
state fair hearings, as these external processes have proven to be an 
effective tool in resolving appeals before reaching a state fair 
hearing. Several commenters also recommended that CMS adopt the deemed 
exhaustion requirement from the private market rules at 45 CFR 
147.136(b)(2)(ii)(F) to ensure that enrollees maintain access to a 
state fair hearing if the managed care plan does not adhere to the 
notice and timing requirements in Sec.  438.408, including specific 
timeframes for resolving standard and expedited appeals.
    Response: We thank the commenters for the many thoughtful and 
specific recommendations regarding proposed Sec.  438.408(f)(1) and 
acknowledge the need to carefully consider the impact of this 
requirement on enrollees. Consistent with our preamble discussion at 
Sec.  438.402(c)(1)(i), we understand commenters' concerns and 
recommendations regarding direct access to a state fair hearing for 
vulnerable populations; however, we decline to adopt this requirement. 
We believe that a consistent and uniform appeals process benefits 
enrollees and will better lead to an expedited resolution of their 
appeal. We have shortened the managed care plan resolution timeframe 
for standard appeals from 45 days to 30 calendar days and shortened the 
managed care plan resolution timeframe for expedited appeals from 3 
working days to 72 hours. We have also lengthened the timeframe for 
enrollees to request a state fair hearing from a maximum of 90 days to 
120 calendar days, counting from the receipt of the adverse appeal 
decision from the managed care plan. We have aligned these timeframes 
with other public and private health care markets and believe this 
ultimately protects enrollees by establishing a national framework for 
a uniform appeals process.
    We agree with commenters that adopting the deemed exhaustion 
requirement from the private market rules at 45 CFR 
147.136(b)(2)(ii)(F) will ensure that enrollees maintain access to a 
state fair hearing if the managed care plan does not adhere to the 
notice and timing requirements in Sec.  438.408, including specific 
timeframes for resolving standard and expedited appeals. As noted in 
our discussion of Sec.  438.402, we are including a deemed exhaustion 
provision in this final rule; we are finalizing text in several 
regulation sections, including Sec.  438.408(c)(3) and (f)(1)(i) to 
implement the deemed exhaustion requirement.
    In addition, we disagree with commenters that recommended that 
states be allowed to establish their own processes and timeframes for 
grievances and appeals that differ from our proposed rule, we are 
persuaded by commenters' recommendations regarding an optional and 
independent external medical review. We agree that an optional external 
medical review could better protect enrollees and be an effective tool 
in resolving appeals before reaching a state fair hearing. Therefore, 
we are finalizing this rule with provisions in several sections, 
including Sec.  438.408(f)(1)(ii), that permit a state to implement an 
external appeal process on several conditions: the review must be at 
the enrollee's option and cannot be a requirement before or used as a 
deterrent to proceeding to the state fair hearing; the review must be 
independent of both the state and managed care plan; the review must be 
offered without any cost to the enrollee; and any optional external 
medical review must not extend any of the timeframes specified in Sec.  
438.408 and must not disrupt the continuation of benefits in Sec.  
438.420.
    Comment: Many commenters disagreed with CMS and recommended 
alternative timeframes at Sec.  438.408(f)(2) for enrollees to request 
a state fair hearing. Commenters recommended that CMS not expand the 
amount of time enrollees have to file and request a state fair hearing 
up to 120 calendar days. Many commenters stated that 120 calendar days 
was too long and would expose managed care plans, states, and enrollees 
to unnecessary financial liability. Commenters also stated that the 120 
calendar days is not consistent with the 90 calendar days in Medicaid 
FFS at Sec.  431.244(f). Commenters recommended that CMS revise the 120 
calendar days to 45 calendar days, 60 calendar days, or 90 calendar 
days. Many commenters also supported the proposed 120 calendar days and 
stated that the new requirement would give enrollees extra time to 
gather the information and documentation they need before proceeding to 
the state fair hearing.
    Response: We disagree with commenters that we should shorten the 
amount of time given to enrollees to request a state fair hearing. We 
believe that 120 calendar days is the necessary and appropriate amount 
of time to give

[[Page 27519]]

enrollees the time they need to gather information and documentation 
before proceeding to the state fair hearing. We note that while the 120 
calendar day requirement may not be consistent with Medicaid FFS at 
Sec.  431.244(f), that Medicaid FFS requirement is only related to the 
first level of appeal. We also note that enrollees have 60 calendar 
days to file the appeal with the managed care plan, and upon notice 
that the managed care plan is upholding their adverse benefit 
determination, the enrollee has the additional 120 calendar days to 
file for state fair hearing. We believe it is important for enrollees 
to file appeals as expediently as possible, but that between the 
managed care plan appeal level and state fair hearing, the total 
timeframe is generally consistent with the private market.
    Comment: One commenter stated that the language ``the earlier of 
the following'' was missing in the proposed change to Sec.  
431.244(f)(1).
    Response: We clarify for the commenter that the language ``the 
earlier of the following'' was deleted in the proposed regulatory text 
to be consistent with the removal of direct access to a state fair 
hearing.
    After consideration of the public comments, we are finalizing Sec.  
438.408 of the rule with some changes from the proposed rule. As 
compared to the proposed rule, the final text at Sec. Sec.  
438.408(c)(3) and 438.408(f)(1) is modified to adopt the deemed 
exhaustion requirement from the private market rules at 45 CFR 
147.136(b)(2)(ii)(F) to ensure that enrollees maintain access to a 
state fair hearing if the managed care plan does not adhere to the 
notice and timing requirements in Sec.  438.408. The regulatory text at 
Sec.  438.408(f)(1) now contains an optional and independent external 
medical review that must be at the enrollee's option, must not be a 
requirement before or used as a deterrent to proceeding to the state 
fair hearing, must be offered without any cost to the enrollee, must 
not extend any of the timeframes specified in Sec.  438.408, and must 
not disrupt the continuation of benefits in Sec.  438.420. Consistent 
with the discussion throughout subpart F, we are replacing the term 
``dispose'' with ``resolve'' in Sec.  438.408 references to resolution 
of the appeal. We are finalizing all other sections as proposed.
(7) Expedited Resolution of Appeals (Sec.  438.410)
    In addition to the revisions to add PAHPs to the scope of this 
regulation, we proposed to revise Sec.  438.410(c)(2) to replace the 
current general language on oral and written notification with a cross 
reference to Sec.  438.408(c)(2), to more specifically identify the 
responsibilities of the MCO, PIHP, or PAHP when extending timeframes 
for resolution. We also proposed a grammatical correction to paragraph 
(b) to replace the word ``neither'' with ``not.'' We proposed no other 
changes to this section.
    We received the following comments in response to our proposal to 
revise Sec.  438.410.
    Comment: A few commenters recommended that CMS revise the language 
at Sec.  438.410(a) to include physical and mental health, as well as 
settings of care, when referring to urgent circumstances that require 
an expedited resolution.
    Response: We agree with commenters that Sec.  438.410(a) could be 
strengthened to include both physical and mental health. We are 
modifying the regulatory text to include this recommendation. However, 
we disagree with commenters that Sec.  438.410(a) should include 
additional language related to settings of care. We believe that the 
current language is clear and requires a managed care plan to maintain 
an expedited appeals process for urgent circumstances, regardless of 
the setting, when taking the time for a standard resolution could 
seriously jeopardize the enrollee's life or health (both physical and 
mental health) or ability to attain, maintain, or regain maximum 
function.
    Comment: A few commenters recommended that CMS revise the 
requirements at Sec.  438.410(b) to add sanctions and penalties for 
managed care plans that do not comply with the prohibition against 
punitive action. One commenter recommended that CMS give examples of 
punitive action.
    Response: We disagree with the commenters' recommendation to add 
sanctions and penalties at Sec.  438.410(b), as such issues are 
addressed elsewhere. Consistent with Sec.  438.700, states determine 
whether an MCO, PCCM, or PCCM entity has violated any regulations or 
requirements and whether to impose corresponding sanctions; under to 
Sec.  438.730, CMS may also impose sanctions for certain failures or 
lack of compliance by an MCO. Further, states have discretion under 
state law to develop enforcement authority and impose sanctions or take 
corrective action. We note that examples of punitive action can include 
a managed care plan's decision to terminate a provider's contract, to 
no longer assign new patients, or to reduce the provider's rates; 
however, we reiterate that the standards in subpart I apply.
    Comment: A few commenters recommended that CMS revise requirements 
at Sec.  438.410(c) to add an appeal right regarding the denial of a 
request for expedited resolution. One commenter recommended that CMS 
add direct access to the state fair hearing if the request for 
expedited resolution is denied. One commenter recommended that CMS add 
requirements to prohibit managed care plans from overriding the 
decision of a health care provider in requesting an expedited 
resolution.
    Response: We appreciate commenters' recommendations but decline to 
add such additional requirements at Sec.  438.410(c). If the request 
for expedited resolution is denied, managed care plans must transfer 
the appeal to the timeframe for standard resolutions. Additionally, 
managed care plans must follow the requirements at Sec.  438.408(c)(2), 
which requires managed care plans to give enrollees notice of their 
right to file a grievance if he or she disagrees with the managed care 
plan's decision to deny the expedited resolution request. Further, we 
do not believe that direct access to the state fair hearing is 
necessary, as the appeal will proceed through the managed care plan's 
one level of appeal, and then if necessary, the enrollee can request a 
state fair hearing if the adverse benefit determination is upheld. 
Finally, we decline to add requirements to prohibit managed care plans 
from overriding the decision of a health care provider in requesting an 
expedited resolution. Managed care plans maintain both medical 
necessity criteria and clinical standards and consult regularly with 
health care providers when making the decision to grant or deny an 
expedited resolution.
    After consideration of the public comments, we are finalizing Sec.  
438.410 as proposed with a modification to Sec.  438.410(a) to include 
both physical and mental health as discussed above.
(8) Information About the Grievance System to Providers and 
Subcontractors (Sec.  438.414)
    In addition to the change proposed throughout this subpart in 
connection with PAHPs, we proposed to update the cross reference from 
Sec.  438.10(g)(1) to Sec.  438.10(g)(2)(xi) to be consistent with our 
proposed revisions to Sec.  438.10, discussed in more detail below in 
section I.B.6.d. of this final rule.
    We received the following comments in response to our proposal to 
revise Sec.  438.414.
    Comment: A few commenters recommended that CMS add references to 
the term ``appeal'' when referencing the grievance system in Sec.  
438.414.

[[Page 27520]]

    Response: We agree with commenters that Sec.  438.414 should be 
revised to include the term ``appeal'' when referencing the grievance 
system and to be inclusive of both grievances and appeals.
    After consideration of the public comments, we are finalizing Sec.  
438.414 as proposed with a modification to include the term ``appeal'' 
when referencing the grievance system.
(9) Recordkeeping Requirements (Sec.  438.416)
    In Sec.  438.416, we proposed to modify the recordkeeping standards 
under subpart F to impose a consistent, national minimum recordkeeping 
standard. The current recordkeeping provisions do not set standards for 
the type of appeals and grievance information to be collected, and only 
stipulate that states must review that information as part of an 
overall quality strategy.
    Specifically, we proposed to redesignate the existing provisions of 
Sec.  438.416 as a new paragraph (a), adding that the state must review 
the information as part of its monitoring of managed care programs and 
to update and revise its comprehensive quality strategy. We proposed to 
add a new paragraph (b) to specifically list the information that must 
be contained in the record of each grievance and appeal: A description 
of the reason for the appeal or grievance, the date received, the date 
of each review or review meeting if applicable, the resolution at each 
level, the date of resolution, and the name of the enrollee involved. 
Finally, we proposed to add a new paragraph (c) to stipulate that the 
record be accurately maintained and made accessible to the state and 
available to CMS upon request.
    We received the following comments in response to our proposal to 
revise Sec.  438.416.
    Comment: Several commenters supported Sec.  438.416(a) and 
recommended additional requirements for CMS to include. A few 
commenters recommended that CMS require an annual report from states as 
part of their ongoing monitoring processes. A few commenters 
recommended that CMS require states to track the numbers of appeals and 
grievances and make such data available to the public. One commenter 
recommended that CMS make aggregate level appeals and grievances data 
available. One commenter also recommended that CMS require states to 
monitor and evaluate their appeals and grievances processes.
    Response: States are required to address the performance of their 
appeal and grievance systems in the managed care program assessment 
report required at Sec.  438.66 of this final rule. States are also 
required to post this program report on their state public Web site for 
public viewing. We do not believe that any additional requirements are 
needed to ensure that states are monitoring and evaluating their 
appeals and grievances processes. While we understand the commenters' 
recommendations regarding access to public and aggregate level data, 
this is not a feasible or practical requirement to add at this time. We 
do not believe that all states or managed care plans have electronic 
systems for tracking appeals and grievances that would easily be 
consumable or transferable for public viewing. While we encourage 
states and managed care plans to be transparent about their appeals and 
grievances processes, we do not believe that additional data 
requirements are appropriate at this time.
    Comment: Several commenters supported the requirements at Sec.  
438.416(b)(1) through (6). One commenter recommended that CMS make (1) 
through (6) optional for states and managed care plans, as some states 
do not need all of the information listed. One commenter recommended 
that CMS add one more requirement to capture the names of staff and 
individuals, including health care professionals, who decided the 
outcome of each appeal and grievance. The commenter stated that the 
actual names of staff may be useful in identifying and/or addressing 
patterns and trends in the grievance and appeal resolution process.
    Response: We disagree with commenters that requirements at Sec.  
438.416(b)(1) through (6) should be optional and at the state's 
discretion. We believe that all of these record requirements are needed 
to ensure accurate and thorough monitoring and evaluation of a state's 
and managed care plan's grievance and appeal system. We also decline to 
add new record requirements for states and managed care plans to 
capture the names of staff and individuals who decided the outcome of 
each appeal and grievance, as we believe this to be an operational and 
internal matter for states and managed care plans. States have the 
authority to require managed care plans to track and record additional 
appeal and grievance elements.
    After consideration of the public comments, we are finalizing Sec.  
438.416 as proposed without modification.
(10) Effectuation of Reversed Appeal Resolutions (Sec.  438.424)
    In addition to adding PAHPs to Sec.  438.424, we proposed to revise 
the current rule in paragraph (a) so that the MCO, PIHP, or PAHP must 
effectuate a reversal of an adverse benefit determination and authorize 
or provide such services no later than 72 hours from the date it 
receives notice of the adverse benefit determination being overturned. 
This is consistent with the timeframes for reversals by MA 
organizations and independent review entities in the MA program, as 
specified in Sec.  422.619 for expedited reconsidered determinations, 
when the reversal is by the MA organization or the independent review 
entity. In addition to providing consistency across these different 
managed care programs, and the increases in efficiency that we predict 
as a result of this alignment, we believe that 72 hours is sufficient 
time for an MCO, PIHP, or PAHP to authorize or provide services that an 
enrollee has successfully demonstrated are covered services. We 
solicited comment on this proposal and on our assumptions as to the 
amount of time that is necessary for an MCO, PIHP, or PAHP to authorize 
or provide services.
    We received the following comments in response to our proposal to 
revise Sec.  438.424.
    Comment: Many commenters supported Sec.  438.424(a) regarding the 
72 hour requirement for managed care plans to reverse the adverse 
benefit determination. Some commenters recommended that CMS revise the 
requirement from 72 hours to 24 hours to ensure quick access to needed 
services. Several commenters disagreed with CMS and recommended a 
longer time requirement, as 72 hours was not feasibly possible to 
reverse an adverse benefit determination. Commenters stated that the 72 
hour requirement would require more managed care plan resources and 
would increase administrative costs to states. One commenter 
recommended that CMS clarify whether the MCO, PIHP, or PAHP must 
authorize or provide the service within 72 hours. One commenter 
recommended that CMS address services that have lapsed while the appeal 
process was pending.
    Response: We appreciate the broad support at Sec.  438.424(a) but 
decline to adopt commenters' recommendations. While we encourage 
managed care plans to reverse the adverse benefit determination as 
quickly as possible and as quickly as the enrollee's health condition 
requires, we do not believe that 24 hours provides enough time for

[[Page 27521]]

managed care plans to authorize or provide the disputed service in many 
cases. We also decline to increase the timeframe, as we believe that 72 
hours is the appropriate amount of time for managed care plans to 
authorize or provide the disputed service. We also note that the 72 
hour requirement is consistent with MA requirements and should be 
familiar to most managed care plans operating across both markets. We 
understand commenters' concerns regarding administrative burden and 
costs, but we believe this is a usual part of doing business in the 
health care market. We clarify for commenters that Sec.  438.424(a) 
requires managed care plans to authorize or provide the disputed 
services promptly; therefore, the MCO, PIHP, or PAHP must, at a 
minimum, authorize the service within 72 hours. We also clarify for 
commenters that lapsed services are the same as services not furnished, 
and managed care plans should promptly authorize or provide such 
disputed services as quickly as the enrollee's health condition 
requires.
    Comment: One commenter recommended that CMS clarify at Sec.  
438.424(a) the requirement if a state or federal court orders the 
reversal of an adverse benefit determination.
    Response: We clarify for the commenter that state and federal court 
orders should be followed and recommend that managed care plans reverse 
the adverse benefit determination consistent with such state and 
federal court order and the requirements at Sec.  438.424(a) and (b).
    Comment: A few commenters recommended that CMS clarify at Sec.  
438.424(b) that enrollees are not responsible for the cost of services 
furnished while the appeal is pending, if the adverse benefit 
determination is reversed. One commenter recommended that managed care 
plans be required to pay for the cost of services and reimburse the 
state for the cost of the appeal.
    Response: We agree with commenters that enrollees should not be 
responsible for the cost of services and note that Sec.  438.424(b) 
requires the state or managed care plan to pay for the services in 
accordance with state policy and regulations. If an enrollee paid for 
such services himself or herself, the enrollee must be reimbursed. We 
decline to add requirements that managed care plans pay the state for 
the cost of the appeal, as this is a state-specific issue and should be 
addressed between the state and managed care plan.
    Comment: One commenter recommended that CMS add requirements at 
Sec.  438.424 to establish MCO, PIHP, and PAHP appeal rights regarding 
the reversal of adverse benefit determinations.
    Response: We decline to add requirements at Sec.  438.424 to 
establish MCO, PIHP, and PAHP appeal rights regarding the reversal of 
adverse benefit determinations, as this is a state-specific issue and 
should be addressed between the state and managed care plan.
    After consideration of the public comments, we are finalizing Sec.  
438.424 as proposed without modification.
c. Medical Loss Ratio (Sec. Sec.  438.4, 438.5, 438.8, and 438.74)
    In keeping with our goals of alignment with the health insurance 
market whenever appropriate and to ensure that capitation rates are 
actuarially sound, we proposed that the MLR for MCOs, PIHPs, and PAHPs 
be calculated, reported, and used in the development of actuarially 
sound capitation rates. Under section 1903(m)(2) of the Act and 
regulations based on our authority under section 1902(a)(4) of the Act, 
actuarially sound capitation rates must be utilized for MCOs, PIHPs, 
and PAHPs. Actuarial soundness requires that capitation payments cover 
reasonable, appropriate and attainable costs in providing covered 
services to enrollees in Medicaid managed care programs. A medical loss 
ratio (MLRs) is one tool that can be used to assess whether capitation 
rates are appropriately set by generally illustrating how those funds 
are spent on claims and quality improvement activities as compared to 
administrative expenses, demonstrating that adequate amounts under the 
capitation payments are spent on services for enrollees. In addition, 
MLR calculation and reporting results in responsible fiscal stewardship 
of total Medicaid expenditures by ensuring that states have sufficient 
information to understand how the capitation payments made for 
enrollees in managed care programs are expended. We proposed to 
incorporate various MLR standards in the actuarial soundness standards 
proposed in Sec. Sec.  438.4 and 438.5, and to add new Sec. Sec.  438.8 
and 438.74. The new regulation text would impose the requirement that 
MLR be calculated, reported and used in the Medicaid managed care rate 
setting context by establishing, respectively, the substantive 
standards for how MLR is calculated and reported by MCOs, PIHPs, and 
PAHPs, and state responsibilities in oversight of the MLR standards.
(1) Medical Loss Ratio as a Component of Actuarial Soundness 
(Sec. Sec.  438.4 and 438.5)
    In Sec.  438.4(b)(8), we proposed that capitation rates for MCOs, 
PIHPs, and PAHPs must be set such that, using the projected revenues 
and costs for the rate year, the MCO, PIHP, or PAHP would achieve an 
MLR of at least 85 percent, but not exceed a reasonable maximum 
threshold that would account for reasonable administrative costs. We 
proposed 85 percent as it is the industry standard for MA and large 
employers in the private health insurance market. Considering the MLR 
as part of the rate setting process would be an effective mechanism to 
ensure that program dollars are being spent on health care services, 
covered benefits, and quality improvement efforts rather than on 
potentially unnecessary administrative activities.
    We explained that it is also appropriate to consider the MLR in 
rate setting to protect against the potential for an extremely high MLR 
(for example, an MLR greater than 100 percent). When an MLR is too 
high, it means there is a possibility that the capitation rates were 
set too low, which raises concerns about enrollees' access to services, 
the quality of care, provider participation, and the continued 
viability of the Medicaid managed care plans in that market. We did not 
propose a specific upper bound for the MLR because states are better 
positioned to establish and justify a maximum MLR threshold, which 
takes into account the type of services being delivered, the state's 
administrative requirements, and the maturity of the managed care 
program.
    In Sec.  438.5(b)(5), we proposed that states must use the annual 
MLR calculation and reporting from MCOs, PIHPs, or PAHPs as part of 
developing rates for future years.
    Comments received in response to Sec. Sec.  438.4(b)(8) and 
438.5(b)(5) are addressed at section I.B.3.b and c. of this final rule.
(2) Standards for Calculating and Reporting Medical Loss Ratio (Sec.  
438.8)
    We proposed minimum standards for how the MLR must be calculated 
and the associated reports submitted to the state so that the MLR 
information used in the rate setting process is available and 
consistent.
    In paragraph (a), we proposed that states ensure through their 
contracts with any risk based MCO, PIHP, or PAHP that starts on or 
after January 1, 2017, the MCO, PIHP, or PAHP meet the standards 
proposed in Sec.  438.8. Non-risk PIHP or PAHP contracts by their 
nature

[[Page 27522]]

do not need to calculate a MLR standard since contractors are paid an 
amount equal to their incurred service costs plus an amount for 
administrative activities. We also proposed that MLR reporting years 
would start with contracts beginning on or after January 1, 2017. We 
requested comment on this timeframe.
    Paragraph (b) proposed to define terms used in this section, 
including the terms MLR reporting year and non-claims cost; several 
terms that are relevant for purposes of credibility adjustments were 
also proposed but are discussed in connection with Sec.  438.8(h). 
Regarding the MLR reporting year, we acknowledged that states vary 
their contract years and we proposed to give states the option of 
aligning their MLR reporting year with the contract year so long as the 
MLR reporting year is the same as the rating period, although states 
would not be permitted to have a MLR reporting year that is more than 
12 months. The 12 month period is consistent with how the private 
market and MA MLR is calculated. In the event the state changes the 
time period (for example, transitions from paying capitation rates on a 
state fiscal year to a calendar year), the state could choose if the 
MLR calculation would be done for two 12 month periods with some period 
of overlap. Whichever methodology the state elects, the state would 
need to clarify the decision in the actuarial certification submitted 
under Sec.  438.7 and take this overlap into account when determining 
the penalties or remittances (if any) on the MCO, PIHP, or PAHP for not 
meeting the standards developed by the state.
    Paragraph (c) addressed certain minimum standards for the use of an 
MLR if a state elects to mandate a minimum MLR for an MCO, PIHP, or 
PAHP. We acknowledged that some states have imposed MLR percentages on 
certain managed care plans that equal or exceed 85 percent and we did 
not want to prohibit that practice. Therefore, as proposed, paragraph 
(c) would permit each state, through its law, regulation, or contract 
with the MCO, PIHP, or PAHP to establish a minimum MLR that may be 
higher than 85 percent, although the method of calculating the MLR 
would have to be consistent with at least the standards in Sec.  438.8.
    Paragraphs (d), (e) and (f) proposed the basic methodology and 
components that make up the calculation of the MLR. We proposed the 
calculation of the MLR as the sum of the MCO's, PIHP's, or PAHP's 
incurred claims, expenditures on activities that improve health care 
quality, and activities specified under Sec.  438.608(a)(1) through 
(5), (7), (8) and (b) (subject to the cap in Sec.  438.8(e)(4)), 
divided by the adjusted premium revenue collected, taking into 
consideration any adjustments for the MCO's, PIHP's, or PAHP's 
enrollment (known as a credibility adjustment). Our proposal used the 
same general calculation as the one established in 45 CFR 158.221 
(private market MLR) with proposed differences as to what is included 
in the numerator and the denominator to account for differences in the 
Medicaid program and population. The proposal for MCOs, PIHPs, and 
PAHPs required calculation of the MLR over a 12-month period rather 
than the 3-year period required by 45 CFR 158.120.
    The total amount of the numerator was proposed in paragraph (e) 
which, as noted above, is equal to the sum of the incurred claims, 
expenditures on activities that improve health care quality, and, 
subject to the cap in paragraph (e)(4), activities related to proposed 
standards in Sec.  438.608(a)(1) through (5), (7), (8) and (b). 
Generally, the proposed definition of incurred claims comported with 
the private market and MA standards, with the proposed rule differing 
in several ways, such as:
     We proposed that amounts the MCO, PIHP, or PAHP receives 
from the state for purposes of stop-loss payments, risk-corridor 
payments, or retrospective risk adjustment would be deducted from 
incurred claims (proposed Sec.  438.8(e)(2)(ii)(C) and (e)(2)(iv)(A)).
     Likewise, if a MCO, PIHP, or PAHP must make payments to 
the state because of a risk-corridor or risk adjustment calculation, we 
proposed to include those amounts in incurred claims (proposed Sec.  
438.8(e)(2)(iv)(A)).
     We proposed that expenditures related to fraud prevention 
activities, as set forth in Sec.  438.608(a)(1) through (5), (7), (8) 
and (b), may be attributed to the numerator but would be limited to 0.5 
percent of MCO's, PIHP's, or PAHP's premium revenues. We also proposed 
that the expenses for fraud prevention activities described in Sec.  
438.8(e)(4) would not duplicate expenses for fraud reduction efforts 
for purposes of accounting for recoveries in the numerator under Sec.  
438.8(e)(2)(iii)(C), and the same would be true in the converse. We 
specifically requested comment on the approach to incorporating fraud 
prevention activities and the proportion of such expenditures in the 
numerator for the MLR calculation, as this proposal was unique to 
Medicaid managed care.
    We proposed that non-claims costs would be considered the same as 
they are in the private market and MA rules. We proposed in Sec.  
438.8(e)(2)(v)(A)(3) that certain amounts paid to a provider are not 
included as incurred claims; we noted an intent to use the illustrative 
list in the similar provisions at Sec.  422.2420(b)(4)(i)(C) and 45 CFR 
158.140(b)(3)(iii) to interpret and administer this aspect of our 
proposal. Incurred claims would also not include non-claims costs and 
remittances paid to the state from a previous year's MLR experience.
    In paragraph (e)(2)(iii)(A), we proposed that payments made by an 
MCO, PIHP, or PAHP to mandated solvency funds must be included as 
incurred claims, which is consistent with the private market 
regulations on market stabilization funds at 45 CFR 158.140(b)(2)(i).
    Paragraph (e)(2)(iv) would take a consistent approach with the 
private market rules at 45 CFR 158.140(b)(4)(ii) that amounts that must 
either be included in or deducted from incurred claims are net payments 
related to risk adjustment and risk corridor programs. We proposed in 
paragraph (e)(2)(v) that the following non-claims costs are excluded 
from incurred claims: Amounts paid to third party vendors for secondary 
network savings, network development, administrative fees, claims 
processing, and utilization management; and amounts paid for 
professional or administrative services. This approach is consistent 
with the expenditures that must be excluded from incurred claims under 
the private market rules at 45 CFR 158.140(b)(3).
    Proposed paragraph (e)(2)(vi) would incorporate the provision in MA 
regulations (Sec.  422.2420(b)(5)) for the reporting of incurred claims 
for a MCO, PIHP, or PAHP that is later assumed by another entity to 
avoid duplicative reporting in instances where one MCO, PIHP, or PAHP 
is assumed by another.
    We also proposed at Sec.  438.8(e)(3) that an activity that 
improves health care quality can be included in the numerator as long 
as it meets one of three standards: (1) It meets the requirements in 45 
CFR 158.150(b) (the private market MLR rule) for an activity that 
improves health care quality and is not excluded under 45 CFR 
158.150(c); (2) it is an activity specific to Medicaid managed care 
External Quality Review (EQR) activities (described in Sec.  438.358(b) 
and (c)); or (3) it is an activity related to Health Information 
Technology and meaningful use, as defined in 45 CFR 158.151 and 
excluding any costs that are deducted or excluded from incurred claims 
under paragraph (e)(2). Regarding activities related to Health 
Information

[[Page 27523]]

Technology and meaningful use, we encouraged states to support the 
adoption of certified health information technology that enables 
interoperability across providers and supports seamless care 
coordination for enrollees. In addition, we referred MCOs, PIHPs, and 
PAHPs to the Office of the National Coordinator for Health Information 
Technology's 2016 Interoperability Standards Advisory (2016 ISA) 
published on November 6, 2015 (available at https://www.healthit.gov/sites/default/files/2016-interoperability-standards-advisory-final-508.pdf), which contains a list of the best available standards and 
implementation specifications enabling priority health information 
exchange use cases.
    Because of our understanding that some managed care plans cover 
more complex populations in their Medicaid line of business than in 
their private market line(s) of business, we believed that the case 
management/care coordination standards are more intensive and costly 
for Medicaid managed care plans than in a typical private market group 
health plan. We proposed to use the definition of activities that 
improve health care quality in 45 CFR 158.150 to encompass MCO, PIHP, 
and PAHP activities related to service coordination, case management, 
and activities supporting state goals for community integration of 
individuals with more complex needs such as individuals using LTSS but 
specifically requested comment on this approach and our proposal not to 
specifically identify Medicaid-specific activities separately in the 
proposed rule. We indicated our expectation that MCOs, PIHPs, and PAHPs 
would include the cost of appropriate outreach, engagement, and service 
coordination in this category.
    Paragraph (f) proposed what would be included in the denominator 
for calculation of the MLR. Generally, the denominator is the MCO's, 
PIHP's, or PAHP's premium revenue less any expenditure for federal or 
state taxes and licensing or regulatory fees. In proposed Sec.  
438.8(f)(2), we specified what must be included in premium revenue. We 
noted our expectation that a state will have adjusted capitation 
payments appropriately for every population enrolled in the MCO, PIHP, 
or PAHP so that the capitated payment reasonably reflects the costs of 
providing the services covered under the contract for those populations 
and meets the actuarial soundness standards in Sec.  438.4 through 
Sec.  438.7. We proposed that any payments by states to managed care 
plans for one-time, specific life events of enrollees--events that do 
not receive separate payments in the private market or MA--would be 
included as premium revenue in the denominator. Typical examples of 
these are maternity ``kick-payments'' where a payment to the MCO is 
made at the time of delivery to offset the costs of prenatal, postnatal 
and labor and delivery costs for an enrollee.
    Paragraph (f)(3) proposed that taxes, licensing and regulatory fees 
be treated in the same way as they are treated in the private market 
and MA, as deductions from premium revenue. Similar to the private 
market MLR rule in 45 CFR 158.161(b), fines or penalties imposed on the 
MCO, PIHP, or PAHP would not be deducted from premium revenue and must 
be considered non-claims costs (proposed Sec.  438.8(e)(2)(v)(A)(4)). 
Consistent with MA, we proposed in paragraph (f)(3)(v) to allow 
Community Benefit Expenditures (CBE), as defined in 45 CFR 158.162(c) 
(which is analogous to the definition in Sec.  422.2420(c)(2)(iv)(A)), 
to be deducted up to the greater of 3 percent of earned premiums or the 
highest premium tax rate in the applicable state multiplied by the 
earned premium for the MCO, PIHP, or PAHP. We requested comment on this 
proposal. In proposed paragraph (f)(4), we incorporated the provision 
for MLR under MA regulations at Sec.  422.2420(c)(4) for the reporting 
of the denominator for a MCO, PIHP, or PAHP that is later assumed by 
another entity to avoid duplicative reporting in instances where one 
MCO, PIHP, or PAHP is assumed by another.
    Paragraph (g) proposed standards for allocation of expenses. MCOs, 
PIHPs, and PAHPs would use a generally accepted accounting method to 
allocate expenses to only one category, or if they are associated with 
multiple categories, pro-rate the amounts so the expenses are only 
counted once.
    We also proposed regulation text to address credibility adjustments 
after summarizing how section 2718(c) of the Public Health Service Act 
(PHS Act) addresses them and the work on credibility adjustments by the 
National Association of Insurance Commissioners (NAIC). In paragraph 
(h), we proposed to adopt the method of credibility adjustment 
described in the NAIC's model regulation on MLR and, to the extent 
possible, to follow the approach used in both the private market (45 
CFR 158.230) and MA and Medicare Part D MLR rules (Sec. Sec.  422.2440, 
423.2440). For our detailed explanation of credibility adjustments, see 
80 FR 31111-31112.
    In paragraph (i)(1), we proposed that the MLR be calculated and 
reported for the entire population enrolled in the MCO, PIHP, or PAHP 
under the contract with the state unless the state directed otherwise. 
Our proposal permitted flexibility for states to separate the MLR 
calculation by Medicaid eligibility group based on differences driven 
by the federal medical assistance percentage (FMAP) (to simplify 
accounting with the federal government), by capitation rates, or for 
legislative tracking purposes. However, while states could divide 
eligibility groups for MLR calculation and reporting purposes, we 
explained that our proposal would not allow different calculation 
standards or use of different MLR percentages for different eligibility 
groups. The state may choose any aggregation method described, but 
proposed paragraph (k)(1)(xii) stipulated that the MCO, PIHP, and PAHP 
must clearly show in their report to the state which method it used.
    We proposed in paragraph (j) minimum standards for when a state 
imposed a remittance requirement for failure to meet a minimum MLR 
established by the state. Under our proposal, an MCO, PIHP, or PAHP 
would pay a remittance to the state consistent with the state 
requirement. We encouraged states to incent MCO, PIHP, and PAHP 
performance consistent with their authority under state law. While 
states would not have to collect remittances from the MCOs, PIHPs, or 
PAHPs through this final rule, we encourage states to implement these 
types of financial contract provisions that would drive MCO, PIHP, and 
PAHP performance in accordance with the MLR standard. In section 
1.B.1.c.(3) of this final rule, we address the treatment of any federal 
share of potential remittances.
    In paragraph (k), we proposed that MCOs, PIHPs, and PAHPs would 
submit a report meeting specific content standards and in the time and 
manner established by the state; we proposed that such deadline must be 
within 12 months of the end of the MLR reporting year based on our 
belief that 12 months afforded enough time after the end of the MLR 
reporting year for the state to reconcile any incentive or withhold 
arrangements they have with the MCOs, PIHPs, and PAHPs and for the 
managed care plans to calculate the MLR accurately. We requested 
comment on whether this is an appropriate timeframe. Our proposal would 
have permitted the state to add content requirements to the mandatory 
reports.
    In paragraph (l), we proposed that MCOs, PIHPs, and PAHPs need not 
calculate or report their MLR in the first year they contract with the 
state to provide Medicaid services if the state

[[Page 27524]]

chooses to exclude that MCO, PIHP, or PAHP from the MLR calculation in 
that year. If the state chose that exclusion option, the first MLR 
reporting year for the MCO, PIHP, or PAHP would be the next MLR 
reporting year and only the experience of the MCO, PIHP, or PAHP for 
that MLR reporting year would be included. We considered whether to 
provide similar flexibility for situations where a Medicaid MCO, PIHP, 
or PAHP covers a new population (that is, the state decides to cover a 
new population of Medicaid beneficiaries in managed care), but 
determined that additional considerations did not need to be factored 
in since capitation payments and any risk mitigation strategy employed 
by the state would already be considered in the numerator and 
denominator. We requested comment on this proposal and whether we 
should further define when a managed care plan newly contracts with the 
state.
    We proposed in paragraph (m) that in any case where a state makes a 
retroactive adjustment to the rates that affect a MLR calculation for a 
reporting year, the MCO, PIHP, or PAHP would need to recalculate the 
MLR and provide a new report with the updated figures.
    In paragraph (n), we proposed that the MCO, PIHP, or PAHP provide 
an attestation when submitting the report specified under proposed 
paragraph (k) that gives an assurance that the MLR was calculated in 
accordance with the standards in this final section.
    We received the following comments in response to our proposals in 
Sec.  438.8.
    Comment: There were several commenters that supported the proposed 
implementation date of the MLR requirement by 2017, while other 
commenters recommended that implementation should be extended by at 
least a year past the proposed date to permit states and managed care 
plans adequate time to make system changes and contractual 
modifications to comply with the provisions. Another commenter 
suggested phasing in the implementation of the MLR.
    Response: We believe that with the changes to the proposed rule in 
this final rule, some systems modifications and contract terms will 
need to be updated to accurately report the MLR; however, because 
states only need to include this provision in the contracts and the 
reporting of the MLR will not actually occur until 2018, we believe 
there is adequate time for managed care plans and states to make any 
necessary systems modifications during the 2017 contract year. We also 
believe that it would not be feasible to devise a phase-in strategy 
that would be fair to all the managed care plans and states. In 
consideration of the generally applicable compliance date of contracts 
starting on or after July 1, 2017, we are finalizing the effective date 
in the proposed rule for MLR reporting requirements for contracts that 
start on or after July 1, 2017.
    Comment: We received numerous comments supporting the proposed rule 
which allows states, consumers and stakeholders the ability to review 
the MLR results, based on a consistent methodology, across managed care 
plans. Alternately, we received comments requesting that CMS allow more 
discretion to states and managed care plans as they believe that 
additional flexibility is necessary to ensure there is adequate managed 
care plan participation in states and ensure that managed care plans 
have the ability to provide services in a flexible manner to support 
the overall health of their beneficiaries. Some commenters provided 
that states should be able to implement other types of mitigation 
strategies, such as profit caps or gain sharing maximums, rather than 
an MLR.
    Response: We agree that the calculation of the MLR should be 
consistent so that there will be some level of meaningful comparison 
across states and that it should be as consistent as possible with 
other markets. Per Sec.  438.66(e)(2)(i), the MLR experience of the 
managed care plans will be included in the financial performance 
section of the annual program report that is made available on the 
state's Web site. With these rules, states may choose to require 
managed care plans to meet a specific MLR threshold that is 85 percent 
or higher and to require a remittance if a managed care plan fails to 
meet the specified MLR percentage. We believe that including additional 
flexibility beyond what is in this final rule would hinder CMS and 
other stakeholders from having an accurate picture of the Medicaid 
managed care landscape. States have the flexibility to use other risk 
mitigation strategies in addition to the MLR calculation, reporting, 
and rate development standards in this part so long as the MLR 
requirements are met.
    Comment: Several commenters supported CMS' position to allow states 
to set a MLR standard that is higher than 85 percent or even believe 
that CMS should require an MLR standard higher than 85 percent, while 
others thought states should have the ability to set an MLR lower than 
85 percent. Other commenters believed that Medicaid managed care plans 
are more similar to the individual market than the large group market 
and that the 80 percent standard applicable to individual market 
insurance should be used for Medicaid managed care plans. In addition, 
some commenters believed that certain types of managed care plans, such 
as dental only plans and other managed care plans, may be disadvantaged 
by the 85 percent standard and thought that such managed care plans 
should only be held to an 80 percent standard (consistent with the 
individual market at 45 CFR 158.210(c)) or that they should be excluded 
from the MLR standard altogether. The dental-only plans stated that the 
claims expenditures for dental-only claims is very low while they still 
have similar operating margins to managed care plans that cover much 
more expensive benefits, which makes an 85 percent MLR nearly 
impossible to meet. They also noted that dental-only plans are not 
subject to the private market MLR reporting and rebate requirements as 
they are an excepted benefit under the PHS Act, and in the interest of 
alignment, this final rule should similarly exempt dental PAHPs.
    Some commenters expressed concern about allowing states to set an 
MLR standard that is higher than 85 percent. These commenters provided 
that states currently have discretion to include expenses in either the 
numerator or the denominator and have set MLRs with those principles in 
mind; however, this final rule would remove that flexibility from 
states to develop and establish rules governing the calculation of the 
MLR. In addition, these commenters were concerned that if a state 
requires an MLR to be met that is too high, managed care plans will be 
incentivized to leave the market. These commenters recommended that CMS 
set an upper limit to a state-established MLR requirement to protect 
managed care plans from a MLR standard that is too high by requiring an 
additional payment to managed care plans if the managed care plans have 
an MLR that exceeds a state-imposed MLR standard that is greater than 
85 percent. Commenters provided that such an additional payment to the 
managed care plans would be necessary to ensure that there is adequate 
funding in every year, as managed care plans are currently able to keep 
excess funds from one year to offset future losses.
    Response: We maintain that requiring capitation rate development to 
project an 85 percent MLR is appropriate to apply to Medicaid managed 
care plans due to their similarity with large group health plans. Most 
Medicaid managed care programs are mandatory for covered populations 
which results in enrollment that is larger, more predictable, and with 
potentially less

[[Page 27525]]

adverse selection than what occurs in the individual market. Therefore, 
we are retaining the minimum target of 85 percent in the final rule for 
the projected MLR used in ratesetting. As this rule only requires the 
MCOs, PIHPs, and PAHPs to calculate and report their MLR experience and 
that the state take it into consideration while setting actuarially 
sound rates, we do not believe that dental-only or other PAHPs will be 
negatively impacted. States, when determining whether to require 
dental-only or other PAHPs to meet a specified MLR standard or be 
subject to a remittance, should take the concerns raised by the 
commenters into consideration.
    We appreciate the concern that states may have a desire to set an 
excessively ambitious MLR requirement, but we believe that states, with 
their understanding of managed care plan's historical experience and 
the unique characteristics of the state's population, are best equipped 
to determine an appropriate MLR when setting minimum MLR requirements, 
which could be above 85 percent. We encourage managed care plans to 
address concerns about state-established MLR requirement with the 
state. Note that the actuarial soundness requirements in Sec.  438.4(a) 
provide that capitation rates project the reasonable, appropriate, and 
attainable costs under the contract and are developed in accordance 
with Sec.  438.4(b).
    Comment: We received some comments that requested CMS allow for a 
process whereby the state has the ability to request an MLR that is 
lower than 85 percent if it is found that the standard would 
destabilize the market or create issues with plan choice or 
competition. They believe that this would be consistent with the 
individual market requirement at 45 CFR 158.301. We also received 
comments that suggested that CMS allow for states to set different MLRs 
for different programs and geographic areas.
    Response: We maintain that the Medicaid managed care market is most 
similar to that of group health plans or the MA market; therefore, we 
do not agree that an MLR standard lower than 85 percent is appropriate. 
As noted in our proposed rule, CMS has allowed states to impose a MLR 
standard higher than 85 percent and to also determine the level at 
which the MLR is calculated and reported (that is, at the contract 
level or by population under the contract).
    Comment: A number of commenters requested clarification as to 
whether their specific managed care plans or products would be subject 
to the MLR reporting requirements in this section. A commenter 
requested clarification as to how the MLR rules would apply to Medicaid 
managed care programs and contracts that cover a small group of 
individuals.
    Response: All Medicaid managed care plans that are an MCO, PIHP or 
PAHP, and states that contract with such managed care plans, need to 
meet the MLR-related requirements of this final rule as of the 
effective date or, if later, the compliance date. Specific requests for 
clarification as to the applicability of this final rule to a 
particular plan or product should be directed to the state or 
appropriate CMS contact. The final rule includes a credibility 
adjustment at Sec.  438.8(h) for those managed care plans with a small 
number of enrollees. Those managed care plans may have credibility 
adjustment(s) applied to the MLR calculation.
    Comment: We received a few comments requesting an explanation as to 
how this MLR provision would be applied to Medicare-Medicaid 
coordinated products approved under financial alignment demonstrations 
under section 1115A of the Act. Commenters stated that these products 
should either be exempted from this requirement or that the MLR be 
compared across both lines of business, rather than individually, due 
to the potential high amount of administrative expenditures associated 
with the Medicaid product. Commenters also suggested that the MLR 
standard be 80 percent for these products to account for that issue.
    Response: Per the requirements in this rule, all Medicaid MCOs, 
PIHPs and PAHPs need to calculate and report their MLR experience for 
Medicaid, unless an MLR covering both Medicare and Medicaid experience 
is calculated and reported consistent with the CMS requirements for an 
integrated Medicare-Medicaid product. We are available to provide state 
specific technical assistance to determine how best to calculate and 
report the MLR in these instances.
    Comment: One commenter requested that CMS clarify that this 
requirement does not apply to PACE programs.
    Response: The rules applicable to PACE are in 42 CFR part 460.
    Comment: A commenter requested that CMS simplify the definition of 
``MLR reporting year'' in Sec.  438.8(b) to reference the state's 
rating period. The commenter suggested that the MLR reporting year (as 
the 12 month period that MLR experience is calculated and reported) 
align with the 12 month rating period for which capitation rates were 
developed. The proposed definition of MLR reporting year provided that 
the 12 month period could be on a calendar, fiscal, or contract year 
basis but must ultimately be consistent with the state's rating period.
    Response: We agree with the commenter that the definition for MLR 
reporting year could be simplified through a reference to the rating 
period. We will finalize the definition of MLR reporting year as a 
period of 12 months consistent with the rating period selected by the 
State. This change does not diminish the flexibility of the state to 
define the rating period. In conjunction with that change, we will add 
a definition for ``rating period'' in Sec.  438.2. The discussion of 
that change is provided in section I.B.3.a. of this final rule.
    Comment: We received a number of comments requesting that CMS 
revise the standard for the MLR calculation to a 3-year rolling average 
basis instead of the 1-year calculation as proposed. Other commenters 
supported the proposed 1-year MLR reporting year. Supporters of the 3-
year data aggregation believe that a 3-year rolling average will allow 
anomalies in membership or other fluctuation to be averaged over time 
and provide a more accurate and predictable result of managed care plan 
performance. Although these commenters acknowledged that the 1-year 
calculation timeframe was consistent with Medicare MLR rules, they 
stated that the Medicaid MLR rules are not governed by statute to 
require a 1-year calculation period and that a 3-year period should be 
adopted.
    Response: The commenters are correct that the Medicare MLR rules 
provide for a 1-year time period. Due to the link between MLR 
experience and the development of actuarially sound capitation rates at 
Sec.  438.4(b)(8) (redesignated in the final at Sec.  438.4(b)(9)), a 
1-year time period will provide more accurate information to the states 
about the performance of their managed care plans. This way, the state 
can match the assumptions underlying the rate setting for that time 
period with the actual MLR experience to better inform rate setting in 
future periods. As we expect rate setting to be done on an annual 
basis, we do not believe a 3-year rolling average should be used for 
the Medicaid MLR calculation. Therefore, we are finalizing the rule 
with the 1-year MLR reporting year.
    Comment: Some commenters requested that CMS standardize the MLR 
reporting year on a calendar year basis. Commenters provided that 
allowing states to choose the 12 month period for the MLR reporting 
year

[[Page 27526]]

would hinder the ability to make comparisons of managed care plans' MLR 
experience across states. Additionally, MLR reporting years that are 
different than a calendar year would not be able to be based on annual, 
audited financial reporting. Another commenter requested information as 
to how CMS would compare programs when states have different benefit 
sets and enrolled populations.
    Response: We agree that a difference in the MLR reporting year and 
other variables in program design may make it challenging to compare 
managed care plan MLR experience across states. However, Sec.  
438.4(b)(8) (redesignated in the final at Sec.  438.4(b)(9)), links MLR 
to the development of actuarially sound rates and states need the 
flexibility to define the MLR reporting year for purposes of comparing 
the assumptions in the rating period to the actual experience in the 
MLR reporting year. We intend to use these reports to help us 
understand how accurate the assumptions were in the development of 
capitation rates. This evaluation may entail comparing MLR experience 
across the states, but such a comparison would not have to be for the 
same time periods and would otherwise be focused on managed care 
contracts that covered similar populations. Our primary comparison will 
be between the managed care plans' MLR experience and the assumptions 
used in the rate development for that same period within a state.
    Comment: Some commenters requested clarification of the phrase in 
Sec.  438.8(c) that read ``If a state elects . . .'' as this appears to 
imply that meeting the minimum MLR standard is optional, whereas the 
preamble to the proposed rule appeared to make the minimum MLR a 
requirement.
    Response: Under this final rule at Sec.  438.8, the calculation and 
reporting of the MLR is a requirement on the managed care plans. For 
capitation rates to be actuarially sound in accordance with Sec.  
438.4(b)(8) (redesignated in the final at Sec.  438.4(b)(9)), the 
capitation rates must be set so that the managed care plan is projected 
to meet at least an 85 percent MLR and failure to meet that MLR 
threshold (or exceeding that threshold) for a rating year must be taken 
into account in setting capitation rates for subsequent periods. 
However, this final rule in and of itself does not require managed care 
plans, as a matter of contract compliance, to meet a specific MLR.
    The regulation text noted by the commenters (``If a state elects to 
mandate a minimum MLR for its . . .'') identifies how the state may 
impose a requirement to meet a minimum MLR--not just calculate and 
report the managed care plan's MLR experience--and that such a minimum 
MLR must be at least 85 percent. We will review the MLR reports during 
the review of the annual rate certification and will inquire about 
current assumptions if it is found that the historical MLR is found to 
be below 85 percent.
    No comments were received on Sec.  438.8(d); however, we will 
finalize that section with a technical edit to remove the designation 
of paragraphs (1) and (2). The substantive regulatory text proposed at 
Sec.  438.8(d)(1) will be finalized as Sec.  438.8(d).
    Comment: One commenter requested that CMS describe what would be 
counted towards the administrative and profit categories rather than 
what would be counted towards the 85 percent in the numerator of the 
MLR calculation.
    Response: We maintain that it is best to be consistent with the 
private and Medicare markets which define the MLR as we proposed; 
therefore, we will continue to define the expenditures that can be 
counted towards the 85 percent in the numerator.
    Comment: A few commenters requested that CMS remove the term 
``medical'' from Sec.  438.8(e)(2)(i)(A) when cross-referencing the 
services defined in Sec.  438.3(e), as some of those services may not 
be medical in nature. Commenters suggested that retaining the term 
``medical'' in the definition of incurred claims would inadvertently 
exclude ancillary or other LTSS services from the numerator. In 
addition, a commenter requested clarification that, in addition to 
services included in the state plan, managed care plans be able to 
treat extra services beyond what is outlined in the state plan as 
incurred claims for purposes of the MLR calculation.
    Response: We agree that services meeting the definition of Sec.  
438.3(e) may not always be medical in nature and are removing the term 
medical from Sec.  438.8(e)(2)(i)(A). We remind commenters that all 
services, including behavioral health, acute care, pharmacy, NEMT, and 
LTSS are included in this definition. Regarding the commenter that 
questioned the treatment of services provided in addition to those 
covered under the state plan, we believe the commenter is referencing 
value-added services. We confirm that these services may be considered 
as incurred claims in the numerator for the MLR calculation.
    Comment: One commenter recommended that CMS change the term 
``reserves'' to ``liability'' in Sec.  438.8(e)(2)(i)(B) as 
``reserves'' in this context has additional meaning beyond an estimate 
of what has already occurred. In addition, the commenter recommended 
that CMS also include ``incurred but not reported'' amounts, as well as 
amounts withheld from paid claims or capitation payments which would 
make the inclusion of Sec.  438.8(e)(2)(i)(C) unnecessary. The 
commenter further stipulated that CMS should clarify that any 
remittances should not be calculated until the amounts withheld from 
network providers are either paid out or retained by the managed care 
plan.
    Response: We agree with the commenter that the use of the term 
``reserves'' in Sec.  438.8(e)(2)(i)(B) was too broad and we have 
modified the text to indicate that unpaid claims liabilities should be 
counted towards incurred claims for purposes of the MLR calculation. We 
also agree that the addition of ``incurred but not reported claims'' 
should be in this paragraph. We do not agree that the provision in 
Sec.  438.8(e)(2)(i)(C), pertaining to withholds from payments made to 
network providers, should be removed. This should remain a distinct 
category of incurred claims in consideration of the expansion of value-
based purchasing. While we agree that in best practice all of these 
payments would either be made or retained by the managed care plan 
before determining remittances, states have the flexibility to develop 
a remittance strategy and to determine whether to calculate the 
remittance before or after these payments are finalized.
    Comment: One commenter stated its understanding of Sec.  
438.8(e)(2)(i)(B) as being that incurred claims would account for 
changes in claims reserves without limitation and that such an approach 
was important for safety-net managed care plans that do not typically 
have larger parent corporations to draw funding from if claims 
expenditures are higher than expected. Another commenter specifically 
requested that certain components of claims reserves noted on the NAIC 
form, such as policy reserves, unpaid claims adjustment expenses, or 
administrative expense liability, be excluded as they are not 
applicable to Medicaid.
    Response: While we agree with the commenter that the provision does 
not specify a limit to changes in claims reserves, we believe this is 
something that states should review when looking at the MLR 
calculation. If a managed care plan is consistently making significant 
changes to claims reserves in the fourth quarter of the MLR reporting 
year, that could be an indication that the managed care plan may have 
not met the MLR standard absent those changes and may not actually need 
those

[[Page 27527]]

additional claims reserves. We do not agree that policy reserves, 
unpaid claims adjustment expenses, or administrative expense liability 
should be excluded from claims reserves. An explicit exclusion of those 
expenses could have the effect of inhibiting innovations in program 
design and, if these items are inapplicable to Medicaid as the 
commenter suggested, there would be minimal amounts reported under 
those reserve categories.
    Comment: One commenter indicated that Sec.  438.8(e)(2)(i)(D) and 
(E) provides that incurred claims include ``[c]laims that are 
recoverable for anticipated coordination of benefits'' or ``[c]laims 
payment recoveries received as a result of subrogation.'' The commenter 
noted that these provisions could be interpreted to mean that claims 
recoverable or received are to be added to the other listed items, when 
in actuality such amounts would be a deducted from incurred claims. To 
the extent that recoveries are identified and included in the overall 
estimate of claims liability, the recoveries would be included in Sec.  
438.8(e)(2)(i)(B). The commenter provided that this interpretation 
would result in only recoveries not included in the estimated liability 
to be accounted for in Sec.  438.8(e)(2)(i)(B).
    Response: The commenter is correct insofar as recoverable and 
recovered claims should be included in incurred claims as negative 
adjustments; the private market MLR rule notes that these should be 
``included'' with the expectation that issuers understand this to mean 
a negative adjustment. The same expectations apply to the Medicaid MLR 
calculation.
    Comment: One commenter requested that CMS clarify why claims that 
are recoverable for anticipated coordination of benefits (COB) and 
claims payment recoveries received as a result of subrogation are 
classified separately at Sec.  438.8(e)(2)(i)(D) and Sec.  
438.8(e)(2)(i)(E).
    Response: The private market rules at 45 CFR 158.140(a)(2) 
distinguish claims that are recoverable for anticipated coordination of 
benefits and claims payment recoveries received as a result of 
subrogation. We do not see a reason to deviate from that standard and 
have implemented it here for calculation of MLR for Medicaid managed 
care plans.
    Comment: One commenter suggested that Sec.  438.8(e)(2)(i)(H), 
which would include reserves for contingent benefits and the medical 
claim portion of lawsuits under incurred claims, was duplicative of 
Sec.  438.8(e)(2)(i)(G), which would include changes in other claims-
related reserves under incurred claims.
    Response: While we appreciate the commenter alerting us to this 
possible duplication, we think that it is helpful to specify in the 
rule that only the medical and no other portions of litigation reserves 
are allowable as an inclusion in incurred claims.
    Comment: One commenter requested that CMS change net adjustments 
for risk corridors or risk adjustment from Sec.  438.8(e)(2)(iv)(A), to 
either be deducted or included under incurred claims in the numerator, 
to the denominator. The commenter stated that this change would be more 
consistent with how premium revenues are calculated in Medicaid.
    Response: We agree with commenters that net adjustments for risk 
corridors or risk adjustment should be in the denominator, rather than 
the numerator, consistent with the MA requirements at Sec.  
422.2420(c)(1)(i). The requirements at 45 CFR 158.140(a)(4)(ii) were 
based on provisions in the Affordable Care Act that were unique to the 
risk corridor program in the private market. Therefore, we agree that 
it is appropriate to align with MA for the treatment of risk adjustment 
in the MLR calculation. To effectuate this change, the proposed text at 
Sec.  438.8(e)(2)(iv)(A) is moved to Sec.  438.8(f)(vi).
    Comment: We received a comment requesting that CMS specify at Sec.  
438.8(e)(2)(v)(A)(3) that expenditures for subcontractors' 
administrative activities need to be considered as administrative costs 
of the managed care plan and treated accordingly for purposes of the 
MLR calculation. The commenter stated that in instances where the 
subcontractor is only providing medical or LTSS services, all of their 
fee can be included in incurred claims, but in cases where they are 
providing a mix of medical or LTSS services and administrative 
activities, the managed care plan should not be able to count that 
entire expense towards incurred claims. Another commenter requested 
that CMS impose the four-part test included in CCIIO technical guidance 
when considering subcontractors' payments as incurred claims.
    Response: We agree that in cases where the amount of the payment to 
the subcontractor includes an amount for administrative activities, 
that amount should be counted as an administrative expense included in 
the MLR calculation. Section 438.8(e)(2)(v)(A)(3) excludes amounts paid 
to subcontractors for administrative activities from inclusion in 
incurred claims. We do not believe we need to impose the four-part test 
at this time, as when a managed care plan is using a subcontractor to 
deliver some of the services under the contract (which may be medical 
or LTSS services) they will count as incurred claims up to the point 
where payments are divided according to medical or LTSS services and 
administrative functions. States have the discretion to apply the four-
part test. A state's decision to use the four-part test, or to not use 
the four-part test, is consistent with the requirements for the 
calculation of the MLR in Sec.  438.8.
    Comment: One commenter requested that CMS clarify what is meant by 
``amounts paid to third party vendors for secondary network savings,'' 
as stated in Sec.  438.8(e)(2)(v)(A)(3). Another commenter believed 
that including this provision may prohibit value-based purchasing and 
requested that CMS remove it to incent state innovation in this area.
    Response: The amounts paid to third party vendors for secondary 
network savings would be payments made by one managed care plan to 
another vendor to purchase their network for use as a secondary 
network. In practice, the managed care plan purchases another managed 
care plan's network to serve as contracted, out-of-network providers so 
as to avoid single-case agreements with those providers, resulting in 
savings on out-of-network service costs. We do not believe including 
this provision would prohibit value-based purchasing or disincent 
managed care plans from entering into such arrangements; issuers in the 
private markets utilize this same business practice. Furthermore, in 
consideration of changes made to the denominator to exclude incentive 
payments from premium revenue, we believe there are adequate incentives 
for value-based purchasing within the scope of the MLR calculation.
    Comment: One commenter requested clarification as to whether 
payments to solvency funds are incurred claims. This commenter noted 
that in their state, the managed care plans may pay into the solvency 
fund at the beginning of the year, but may receive some or all of that 
money back depending on how the managed care plan performed.
    Response: To clarify the treatment of payments to and from solvency 
funds, we are finalizing the rule to move the provision of net payments 
to or receipts from solvency funds under the provision of incurred 
claims that either includes or deducts the payments or receipts related 
to solvency funds from incurred claims at Sec.  438.8(e)(2)(iv). The 
designation of this provision at Sec.  438.8(e)(2)(iv) is due to other 
modifications to proposed Sec.  438.8(e)(2)(iv)(A) relating to risk

[[Page 27528]]

adjustment and risk corridors addressed earlier in this section of the 
preamble This revision should address the instances where a managed 
care plan receives funding from the solvency fund.
    Comment: One commenter noted that Sec.  438.8(e)(2)(ii)(B) provides 
that items to be deducted from incurred claims include, ``Prescription 
drug rebates received.'' The commenter recommended that we change this 
wording to reflect rebates received and accrued. In addition to 
pharmaceutical rebates receivable and claim overpayment receivables, 
the NAIC Annual Statement also includes the following categories of 
health care receivables: loans and advances to providers, capitation 
arrangement receivables, risk sharing receivables, and other health 
care receivables. The commenter also requested clarification regarding 
whether both admitted and non-admitted health care receivables are 
included in incurred claims.
    Response: We agree that the language should be changed to reference 
rebates that have been received and accrued and will finalize the rule 
with this language included in Sec.  438.8(e)(2)(ii)(B). We also 
confirm that both admitted and non-admitted health care receivables are 
included when determining the amount of incurred claims.
    Comment: One commenter noted that Sec.  438.8(e)(2)(ii)(C) provides 
that the incurred claims in the numerator are to be reduced by ``State 
subsidies based on a stop-loss payment methodology,'' but the 
denominator does not also allow for a specific inclusion or exclusion 
based on premiums paid or received from the reinsurance provider with 
whom the managed care plan may contract. This commenter suggested some 
parameters that CMS should consider in allowing those revisions to the 
denominator.
    Response: The intention was to address these types of risk sharing 
mechanisms under Sec.  438.8(e)(2)(iv)(A) rather than Sec.  
438.8(e)(2)(ii)(C). We recognize that the language initially proposed 
was potentially limited to only risk corridors or risk adjustment 
programs and therefore we have revised this paragraph to reference risk 
sharing mechanisms broadly to encompass risk corridors, risk 
adjustment, reinsurance and stop-loss programs that are included in the 
contract with the MCO, PIHP or PAHP. We believe this change along with 
the deletion of Sec.  438.8(e)(2)(ii)(B), addresses the issue.
    Comment: One commenter noted that Sec.  438.8(e)(2)(iii)(B) 
provides that incurred claims used in the MLR calculation include, 
``The amount of incentive and bonus payments made to network 
providers.'' Commenters stated that those payments should not be 
limited to payments actually made and should include accruals for 
amounts expected to be paid.
    Response: We agree that amounts expected to be paid should also be 
included in this calculation. We encourage managed care plans and 
states to exercise caution and ensure that these payments are made 
within the 12 month period after the end of the MLR reporting year. We 
believe this should provide sufficient time for managed care plans to 
calculate incentive or bonus payments and issue such payments to 
network providers.
    Comment: Several commenters opposed including unpaid cost sharing 
amounts in the premium revenue component of the MLR denominator because 
they did not want to provide additional incentives for managed care 
plans to collect cost sharing from enrollees. Commenters did not 
believe that managed care plans should always collect the cost sharing 
amounts from the enrollees.
    Response: We believe that the incentives to collect cost sharing, 
or for managed care plans to pay providers their claim amount less the 
cost sharing that the provider should be collecting, is already an 
incentive for managed care plans based on the way actuarially sound 
rates are set. States now reduce the claims expense by cost sharing 
when determining the amount to be paid to the managed care plans. We do 
not believe that including unpaid cost sharing in the denominator would 
further incentivize managed care plans to collect those amounts. 
Further, most cost sharing in Medicaid is collected at the provider 
level at the point of service. Only in limited circumstances would we 
expect this to be a factor in the Medicaid MLR calculation due to the 
cost sharing structure.
    Comment: We received multiple comments requesting that CMS 
specifically include activities related to service coordination, case 
management and activities supporting state goals for community 
integration in the definition of quality improvement activities. 
Commenters stressed that these activities should not be excluded from 
the numerator as they believe they are important activities that the 
managed care plans should be doing for a population with complex health 
care needs. Other commenters recommended more specific definitions to 
preclude managed care plans from including general operating expenses 
under this category for the MLR calculation. Commenters recommended 
that CMS conduct or require states to implement an approval or audit 
process to make sure that the activities are actually improving the 
quality of health care.
    Response: We appreciate the need for these types of activities to 
be considered health care quality improving activities and agree that 
the types of activities described by the commenters should be included 
in the numerator. We disagree with the commenters that these activities 
should be listed explicitly in the rule. After reviewing the 
description in 45 CFR 158.150, we believe that all the activities 
described by the commenters are already included in the definition and 
do not require explicit reference in the rule outlined in Sec.  438.8. 
For example, 45 CFR 158.150(b)(2)(i)(A)(1) provides that case 
management and care coordination are explicitly included in activities 
that improve health outcomes which would encompass these activities for 
all individuals enrolled in the plan including enrollees using LTSS, or 
other enrollees with other chronic conditions. We are concerned that if 
we provide a specific list of these activities, some unique state 
programs that offer similar types of activities with a different name 
would be precluded from the category and potentially not included in 
the numerator.
    While the definition of quality improvement activities is broad, 
the requirements for accounting for general operating expenses, also 
known as non-claims costs, are not. Section 438.8(b) explicitly 
provides that non-claims costs are administrative services that are not 
expenditures on quality improving activities as defined at Sec.  
438.8(e)(3). We decline to institute an approval process for activities 
that could qualify as quality improvement activities as that would be 
inconsistent with the MA and private market MLR requirements; however, 
states are able to do so if they choose.
    Comment: Some commenters requested that CMS make clear that 
activities related to Health Improvement Technology (HIT) not be 
limited to what qualifies as ``meaningful use'' because some providers, 
such as behavioral health or LTSS providers, do not meet the 
requirements for meaningful use. These commenters also requested that 
CMS allow states to receive matching funds for efforts to help 
providers improve their HIT for those providers left out of the initial 
meaningful use program.
    Response: The private market rules at 45 CFR 158.151 allow payments 
to providers who do not qualify for the HHS meaningful use payments to 
be included in the numerator of the MLR calculation. The ability to 
claim federal

[[Page 27529]]

matching funds on HIT activities for other provider types is outside 
the scope of this rule.
    Comment: Some commenters requested that CMS expand the types of 
activities that can be counted as activities that improve health care 
quality related to wellness incentives so that managed care plans can 
count the costs associated with providing those payments to more than 
the Medicaid population. They believe that these activities are 
necessary to ensure better quality of life and care and that limiting 
the expenditures to just the Medicaid population will cause the managed 
care plans to limit the scope and eligibility of the programs and make 
them less effective.
    Some commenters requested that additional costs related to 
calculating and administering enrollee incentives for the purposes of 
improving quality be included either as an activity that improves 
health care quality or as a separate category under the numerator. 
Commenters stated that such a change should address social determinants 
of care, promoting patient engagement, and improving self-sufficiency.
    Response: We agree that wellness programs have the potential to 
positively impact the community and the Medicaid population, but we 
disagree that the cost of providing these activities to those outside 
of the Medicaid population should be included in quality improvement 
activities as part of the MLR calculation. Managed care plans that have 
other lines of business or that may be considered non-profit have other 
opportunities to include any additional expenses for wellness 
activities in the MLR calculation in accordance with the regulatory 
requirements for those respective product lines or as part of CBE. 
Therefore, we are not changing the wellness program definition to allow 
additional expenditures other than what is already included in the 
current private market rule at 45 CFR 158.150.
    We believe that only those enrollee incentive program expenses that 
meet the requirements of 45 CFR 158.150 should be counted towards the 
numerator, and would already qualify without specifying that in these 
rules. Administrative costs for incentive programs that do not meet the 
requirements under 45 CFR 158.150 cannot be included in the numerator; 
therefore, we will finalize the rule as proposed.
    Comment: One commenter requested guidance on the activities that 
increase the likelihood of desired health outcomes in 45 CFR 158.150. 
The commenter also requested that CMS remove the requirement that these 
quality improvement activities be ``grounded in evidence-based 
medicine'' on the basis that retaining it may exclude emerging quality 
improving activities.
    Response: We do not intend to publish guidance on what constitutes 
``grounded in evidence-based medicine'' specifically for Medicaid 
purposes as we believe this is a generally accepted and understood 
concept. As noted in the proposed rule, the language in 45 CFR 158.150 
is sufficiently broad to cover the range of quality improving 
activities that occur in Medicaid managed care programs.
    Comment: We received a few comments about the types of activities 
that should be considered quality improvement activities. One commenter 
requested that CMS consider accreditation activities and costs as 
activities that improve health care quality. Another commenter 
requested that CMS include provider credentialing activities as an 
activity that improves health care quality in the MLR calculation. A 
commenter requested that CMS include Medication Therapy Management 
(MTM) as an activity that improves health care quality. Several 
commenters listed specific activities performed by managed care plans 
and requested clarification as to whether those activities would be 
considered activities that improve health care quality.
    Response: We do not believe that all fees incurred by the managed 
care plan related to accreditation should be considered quality 
improvement activities. The private market rules at 45 CFR 
158.150(b)(2)(i)(A)(5) allow for accreditation fees directly associated 
with quality of care activities to be accounted for as a quality 
improvement activity in the numerator and the same standard applies to 
the Medicaid MLR calculation. Per 45 CFR 158.150, provider 
credentialing activities are specifically excluded from quality 
improvement activities. As quality improvement activities for the 
Medicaid MLR calculation incorporate 45 CFR 158.150, provider 
credentialing activities are similarly excluded. In some cases MTM may 
be considered quality management but in others it may actually be a 
service covered under the contract. If managed care plans have 
questions about inclusion of any services or additional activities they 
provide to their enrollees in the context of quality improvement 
activities, they should discuss those services or additional activities 
with the state to determine if they qualify as quality improvement 
activities, incurred claims, or administrative expenses.
    Comment: One commenter suggested that claims for the high-risk 
populations be excluded from incurred claims to reduce pricing 
volatility and provide for better predictability in the calculation of 
the MLR.
    Response: We understand that high risk populations may have more 
claims volatility but this is generally mitigated by the capitation 
payments for these individuals, as well as by any stop-loss or 
reinsurance payments. Therefore, these claims should be included as 
incurred claims in the MLR calculation.
    Comment: One commenter requested that CMS consider telehealth as 
part of incurred claims.
    Response: Telehealth is considered a method of delivery for state 
plan services and such expenditures would be included in incurred 
claims.
    Comment: One commenter requested clarification as to how a network 
provider incentive arrangement would be accounted for in the MLR 
calculation.
    Response: We believe that these types of network provider incentive 
programs, which are different than incentive arrangements for managed 
care plans described in Sec.  438.6(b)(2), can be considered in the MLR 
calculation. Specifically, the funds for payments related to network 
provider incentives are included in the managed care plan's premium 
revenue and would therefore be reported in the denominator and the 
payments made to network providers as a result of the incentive program 
would be considered incurred claims.
    Comment: One commenter requested that CMS define ``community 
integration activities'' such that those expenses could be included in 
the numerator of the MLR calculation.
    Response: We believe that some activities that could be considered 
community integration could be categorized differently within the 
numerator for purposes of the MLR calculation. For example, some 
activities may be actual non-medical state plan benefits and could be 
included as part of incurred claims whereas others may be considered 
quality improvement activities. Since the rule provides flexibility, we 
decline to establish federal parameters for the treatment of community 
integration activities and encourage states to work with their 
contracted managed care plans to determine the appropriate treatment 
for reporting the expenses of these activities in the numerator of the 
MLR calculation.
    Comment: One commenter noted the absence of a reference to ``cost

[[Page 27530]]

avoidance'' in the MLR calculation, which is the proactive process that 
managed care plans use to find other insurance coverage or sources of 
payment for enrollees' covered services and which account for managed 
care plan savings in TPL activities. The commenter requested that CMS 
modify the rule to allow for this expense to be included in incurred 
claims or in another appropriate classification within the numerator.
    Response: We decline to modify the rule to permit managed care 
plans to include their ``cost avoidance'' expenses in the calculation 
of the MLR numerator. Expenses of this nature are not an adjustment to 
an issuer's MLR calculation under 45 CFR part 158 and such expenses are 
correctly treated as a managed care plan's administrative, or non-
claims, expense.
    Comment: We received several comments that requested clarification 
as to how pass-through payments would be treated in the numerator and 
denominator for the MLR calculation and recommended that these payments 
should be deducted from both components of the calculation. Commenters 
provided that pass-through payments could include GME or supplemental 
payments to network providers that are not considered risk-based 
payments to the managed care plan as the additional pass-through 
payment built into the capitation rate is expected to be made to the 
network provider.
    Response: We agree that in the instances where the managed care 
plan is directed to pay certain amounts to specified providers in a way 
that is not tied to utilization or quality of services delivered, that 
those pass-through payments should not be counted in either the 
numerator or the denominator as they could artificially inflate the 
managed care plan's reported MLR. We are finalizing this rule to 
explicitly exclude pass-through payments, in new text in paragraphs 
Sec.  438.8(e)(2)(v)(C) and (f)(2)(i), so that such payments are not 
included in the MLR calculation. We discuss permissible pass-through 
payments in Sec.  438.6(d) and at I.B.3.d. of this final rule.
    Comment: One commenter requested that CMS clarify that the premium 
revenue used in the denominator be on a restated or adjusted basis 
rather than a reported basis.
    Response: The significance of the commenter's use of ``restated or 
adjusted basis'' is not clear. However, the basis for the premium 
revenue for purposes of determining the denominator for the MLR 
calculation may be the direct earned premium as reported on annual 
financial statements filed with state regulators or the direct earned 
premium attributable solely to coverage provided in the reporting year 
that reflects retroactive eligibility adjustments and uses the same 
run-out period as that for claims. We anticipate that the only time a 
managed care plan would use the first approach is when the MLR 
reporting year is on a calendar year basis since annual financial 
statements are based on a calendar year. If the MLR reporting year is 
not on a calendar year basis, the second approach would apply.
    Comment: Some commenters objected to the proposal at Sec.  
438.8(e)(4) that would include the cost of fraud prevention activities 
in the numerator of the MLR calculation. They stated that the program 
integrity activities referenced in Sec.  438.608(a)(1) through (5), 
(7), (8) and (b) were activities that managed care plans should be 
engaged in as part of normal business operations. Some of these 
commenters suggested that a better alternative to assuring enhanced 
program integrity would be development and implementation of additional 
performance measures that managed care plans must meet to include fraud 
prevention activities in the numerator for the MLR calculation. 
Commenters opposed to this proposal stated that Sec.  
438.8(e)(2)(iii)(C) provides sufficient financial incentive to the 
managed care plans to conduct fraud prevention activities. Commenters 
that supported the proposal requested that CMS include a similar 
provision in the private market and Medicare rules. Others stated that 
it is administratively challenging to differentiate administrative 
activities in general from others related to fraud prevention and could 
result in managed care plans attributing expenditures in excess of what 
was actually related to fraud prevention activities in the MLR 
numerator.
    Several commenters supported the proposal at Sec.  438.8(e)(4) to 
include the cost of fraud prevention activities in the numerator of the 
MLR calculation but requested that CMS further define these activities 
and recommended that such activities not be subject to a cap. 
Commenters that supported the proposal requested that CMS include a 
similar provision in the private market and Medicare rules.
    Response: In light of our recent decision not to incorporate 
expenses for fraud prevention activities in the MLR for the private 
market within the Patient Protection and Affordable Care Act; HHS 
Notice of Benefit and Payment Parameters for 2017 final rule, which 
published in the March 8, 2016 Federal Register (81 FR 12204, 12322), 
we believe that it is similarly premature for Medicaid to adopt a 
standard for incorporating fraud prevention activities in the MLR. 
Consideration of fraud prevention activities should be aligned, to the 
extent possible, across MLR programs. Therefore, we will finalize Sec.  
438.8(e)(4) with the heading ``Fraud prevention activities'' and 
specify that ``MCO, PIHP, or PAHP expenditures on activities related to 
fraud prevention as adopted for the private market at 45 CFR part 158'' 
would be incorporated into the Medicaid MLR calculation in the event 
the private market MLR regulations are amended. We will retain the 
proposed requirement in this paragraph that: ``Expenditures under this 
paragraph shall not include expenses for fraud reduction efforts in 
Sec.  438.8(e)(2)(iii)(C).''
    While expenses related to program integrity activities compliant 
with Sec.  438.608 will not be explicitly included in the MLR 
calculation at this time, we underscore the importance of those 
activities. Consistent with Sec.  438.608, contracts must require that 
managed care plans adopt and implement measures to protect the 
integrity of the Medicaid program.
    After consideration of public comments, we are finalizing Sec.  
438.8(e)(4) to incorporate standards for fraud prevention activities in 
the MLR calculation as adopted for the private market at 45 CFR part 
158.
    Comment: Some commenters requested that CMS exclude withhold and 
incentive payments from premium revenue so that managed care plans are 
not disincentivized to meet performance measures under such 
arrangements in light of potential remittance requirements within a 
state if a state-established MLR threshold is not satisfied. In 
addition, commenters requested guidance as to how the 5 percent limit 
on incentive payments relates to the MLR calculation.
    Response: We agree with the commenters that incentive payments made 
to the managed care plan in accordance with Sec.  438.6(b)(2) should 
not be included in the denominator as such payments are in addition to 
the capitation payments received under the contract. The limit on 
incentive arrangements in Sec.  438.6(b)(2) is not impacted by the 
requirements in Sec.  438.8. However, payments earned by managed care 
plans under a withhold arrangement, as specified at Sec.  438.6(b)(3), 
should be accounted for in premium revenue for purposes of the MLR 
calculation because the amount of the withhold is considered in the 
rate development process and reflected in

[[Page 27531]]

the rate certification. To that end, we are finalizing Sec.  
438.8(f)(2)(iii) to clarify that payments to the MCO, PIHP, or PAHP 
that are approved under Sec.  438.6(b)(3) are included as premium 
revenue. Amounts earned by the managed care plans under a withhold 
arrangement will be included in the denominator as premium revenue. Any 
amounts of the withhold arrangement that are not paid to the managed 
care plans would not be included as premium revenue.
    Comment: CMS received a comment that requested clarification that 
all taxes (state, city, and the Health Insurance Provider Fee) are 
deducted from the premium revenue in the denominator under Sec.  
438.8(f)(3)(iv).
    Response: We agree that all taxes applied to the managed care 
plan's premium should be deducted from premium revenue. We have 
modified the regulation text at Sec.  438.8(f)(3)(iv) to specify what 
other types of taxes in addition to state taxes may also be deducted 
from premium revenue. The Health Insurance Provider Fee is addressed at 
Sec.  438.8(f)(3)(iii) and is treated as a federal tax.
    Comment: Some commenters requested further guidance as to the 
expenditures that qualify as community benefit expenditures (CBE) and 
would therefore be subtracted from premium revenue in the denominator 
under Sec.  438.8(f)(3)(v). These commenters also requested that states 
and CMS receive stakeholder input in determining which CBE are actually 
benefiting the community.
    Response: We will not specify in the regulation which expenditures 
qualify as CBE beyond the incorporation of the definition of CBEs in 45 
CFR 158.162(c), as it may differ across state Medicaid managed care 
programs. We are available to provide technical assistance to states on 
this issue.
    Comment: One commenter stated that CBE should only be excluded from 
the denominator if the CBE is required to meet the managed care plan's 
non-profit or tax-exempt status. The commenter suggested that if CMS 
permitted CBE to be excluded from the denominator, such deductions 
should be limited to 1 percent of premium. Another commenter commended 
CMS for proposing that CBE be deducted from the denominator so that 
non-profit managed care plans would not be disadvantaged in the MLR 
calculation and they supported the proposed limit of the higher of 3 
percent or the highest premium tax rate in the applicable state.
    Response: We agree that not permitting deductions of CBE from the 
denominator would discourage managed care plans that are exempt from 
federal income taxes from participating in this market. We believe that 
the proposed cap at the higher of 3 percent or the highest premium tax 
rate in the applicable state is consistent with other markets and is an 
equitable approach across managed care plans contracted with the state. 
Therefore, we are finalizing Sec.  438.8(f)(3)(v) as proposed to permit 
the deductions of CBE from premium revenue.
    Comment: Some commenters supported CMS' proposal in Sec.  438.8(h) 
that a credibility adjustment should be applied. One commenter 
requested that CMS simplify the credibility adjustment by using 
beneficiary thresholds or by using the population enrolled as opposed 
to the current credibility factors used for private market plans and 
developed by the NAIC, as they do not believe that the NAIC methodology 
is appropriate for Medicaid.
    Response: Although we agree that populations in the Medicaid 
program as compared to the Medicare or private markets may have 
different characteristics, we maintain that the approach in the 
proposed rule will best allow smaller plans to account for their 
membership differences. In setting credibility factors by population 
such as TANF, SSI or CHIP as the commenter proposed, states are likely 
to have smaller membership of each population by managed care plan and 
would likely not achieve full credibility across the contract.
    Comment: Some commenters requested that CMS specify at Sec.  
438.8(i) that the MLR can only be calculated at the contract level and 
requested that CMS not allow states to require managed care plans to 
calculate the MLR by population. These commenters suggested that there 
are certain functions of a managed care plan that would be difficult to 
separate according to population and would complicate the calculation 
of an accurate population-specific MLR. Other commenters requested that 
if a state does require a remittance, that the managed care plan must 
only pay a remittance on the entire contract and not on specific 
populations.
    Response: While we agree that there may be some functions that are 
easier to calculate on a contract wide basis, we believe that some 
states may wish to have an MLR calculated on a population-specific 
basis and a remittance paid separately to further inform rate 
development for a specific population. In instances where the state may 
not have sufficient historical information for a population, it may be 
beneficial to have the MLR calculated separately, especially in the 
early years of operation. Considering these circumstances, states 
should retain the flexibility to choose whether the MLR is to be 
calculated, and a remittance requirement applied, on a contract-wide or 
population-specific basis.
    Comment: One commenter requested clarification as to how to 
aggregate the data if the managed care plan has more than one contract 
with the state and, if aggregation is allowed between contracts, the 
criteria by which such aggregation is conducted.
    Response: In instances where a managed care plan has more than one 
contract with the state, the state can determine how to aggregate the 
data. In Sec.  438.8(a), the MLR reporting year must be the contract 
year or rating period; therefore, any aggregation across contracts must 
use a consistent MLR reporting year. If aggregation occurs, states 
should consider any differences in the rate development for contracts 
held by the same managed care plan to determine how the MLR experience 
should be taken into account when setting capitation rates for future 
rating periods.
    Comment: One commenter requested that CMS allow aggregation of data 
for the calculation of the MLR across all Medicaid and CHIP product 
lines in the state. The commenter provided that this flexibility would 
minimize pricing volatility and reduce administrative burden on the 
managed care plans.
    Response: We do not believe that aggregating the MLR calculation 
across both Medicaid and CHIP product lines is in the best interest of 
the states or the federal government for oversight of its Medicaid and 
CHIP managed care plans. The Medicaid requirements for actuarial 
soundness do not apply to CHIP. Separate reporting of MLR experience 
for Medicaid and CHIP product lines is imperative as Sec.  438.4(b)(8) 
(redesignated in the final at Sec.  438.4(b)(9)), incorporates MLR into 
the development of actuarially sound capitation rates for Medicaid 
managed care plans.
    After consideration of public comments, we will finalize Sec.  
438.8(i) with technical edits to delete designations for paragraphs (1) 
and (2), as such designations are unnecessary.
    Comment: Several commenters urged CMS to require that a minimum MLR 
percentage be met and to require that managed care plans pay 
remittances if they fail to meet the MLR. They believed that with the 
regulations as proposed, an MLR of 85 percent appeared optional and 
that CMS would not achieve the high quality care if such requirements 
were not in place. Alternately, other commenters supported the proposal 
to allow states to

[[Page 27532]]

decide whether to require remittances. Some commenters urged CMS to 
include provisions similar to those in the Medicare Advantage and Part 
D MLR regulation, where, if over multiple years the plans are not 
meeting the MLR, the state must stop new enrollment or terminate the 
contract.
    Response: We agree that a minimum MLR with a remittance requirement 
is a reasonable and favorable approach to ensure high quality of care 
and appropriate service delivery in Medicaid managed care programs. 
However, there is no statutory basis to implement a federal mandatory 
minimum MLR or a remittance requirement in Medicaid.
    Comment: CMS received a comment requesting that we clarify that if 
a state does require a remittance under Sec.  438.8(j), it should 
require the amount of the remittance to bring the managed care plan's 
incurred claims up to the state-established MLR standard, as is done 
for the private market. Additionally, this commenter requested that CMS 
direct states, in the cases where they require a remittance, to do so 
using a lower minimum MLR standard than is used to set capitation rates 
as the MLR standard for rate setting is the average expected across all 
managed care plans. Otherwise, if a remittance was collected from each 
managed care plan that was below the 85 percent MLR standard, then the 
average MLR would actually be higher than 85 percent. Some commenters 
requested that CMS specify that when states require managed care plans 
to provide remittances, they delay the application of a remittance 
requirement until a population has been enrolled in the managed care 
program for 2 years. In addition, commenters requested that states 
consider a 3-year average when applying a remittance requirement 
instead of a single MLR reporting year. Commenters stated that these 
approaches would reduce volatility and any anomalies in the data while 
the covered population stabilizes.
    Response: This final rule does not set the methodology for 
calculating remittances. This rule requires the use of the MLR 
calculation and reporting standards set forth in Sec. Sec.  438.8 and 
438.74, requires that actuarially sound capitation rates be developed 
so that a managed care plan may achieve an MLR of at least 85 percent 
as described in Sec.  438.4(b)(8) (redesignated in the final at Sec.  
438.4(b)(9)), and requires the return to CMS of the federal 
government's share of any remittance a state collects. Because 
remittances under this final rule will be imposed under state 
authority, we believe the state is best suited to determine the 
methodology for remittances.
    Comment: We received some comments that suggested CMS require 
states that opt to impose remittances to develop plans for reinvesting 
the remittances to provide greater access to home and community-based 
services (HCBS) or investment into other public health initiatives. 
Another commenter recommended that CMS require the states and managed 
care plans to implement a tiered savings rebate program instead of 
remittances.
    Response: While we agree that investments for greater access to 
HCBS services or other public health programs are important, we have 
not proposed and do not finalize requirements on how states use the 
state share of any remittance collected from a managed care plan. Per 
the requirements in Sec.  438.74, if a state receives a remittance from 
a managed care plan, the state is required to repay the federal share 
of that remittance to CMS. We do not intend to require states to use 
the state share of that remittance for any specific purpose, although 
we urge commenters to discuss with their states the best use of the 
state share of any remittance.
    Comment: One commenter expressed concern about the lack of clarity 
in the regulation for states that currently have rebate methodologies.
    Response: We assume that when the commenter discusses rebate 
methodologies they mean remittance requirements, and is asking how CMS 
reviews or oversees such approaches across states. As part of the 
contract review, CMS will be able to note states that include a 
specific remittance requirement and will be able to monitor the 
remittances on the CMS-64 form that states use for purposes of claiming 
FFP. When states receive a remittance, they will need to specify a 
methodology to CMS as to how they determined the appropriate amount of 
the federal share that is paid back. CMS will review those 
methodologies at the time of repayment.
    Comment: A commenter requested clarification as to how to interpret 
the MLR reporting year definition in conjunction with the provision in 
Sec.  438.8(k)(1)(xi) that requires the managed care plan to reconcile 
the reported MLR experience to the audited financial report, as the two 
may not cover the same time period.
    Response: To clarify our expectations for this activity, we will 
finalize Sec.  438.8(k)(l)(xi) to change the term ``reconcile'' to 
``compare''. Although a managed care plan may not be able to completely 
reconcile the MLR experience to the dollars reported in the audited 
financial report, we believe that a comparison to the audited financial 
report should be conducted to ensure that the MLR calculation is 
accurate and valid as compared to other financial reporting. We 
acknowledge that the time period of the MLR reporting year and the 
audited financial report may differ in ways that should be taken into 
account during the comparison.
    Comment: Some commenters suggested that managed care plans would 
not be able to complete the final MLR calculation within the 12 month 
period following the MLR reporting year as proposed at Sec.  
438.8(k)(2). Commenters stated that some payments such as maternity 
case rate payments, incentive payments or pharmacy rebate payments take 
longer to finalize and may not be fully accounted for in the 12 months 
after the MLR reporting year.
    Response: We do not agree that these payments cannot be finalized 
within the 12 months following the MLR reporting year. Further, 
extending the timeframe beyond the 12 month period would be 
inconsistent with MA or the private market MLR regulations. Therefore, 
we will finalize Sec.  438.8(k)(2) as proposed without modification.
    Comment: One commenter requested that CMS clarify that the 
provision in Sec.  438.8(k)(3), regarding managed care plan reporting 
of the MLR experience only applies to third party vendors that provide 
claims adjudication for the MCO, PIHP or PAHP.
    Response: We proposed in Sec.  438.8(k)(3) that managed care plans 
must require third party vendors that provide services to enrollees to 
supply all underlying data to the managed care plan within 180 days of 
the end of the MLR reporting year or within 30 days of such data being 
requested by the managed care plan, whichever date is earlier, so that 
the managed care plan can validate that the cost allocation, as 
reported by the managed care plans on their MLR reporting form 
submitted to the state per Sec.  438.8, accurately reflects the 
breakdown of amounts paid to the vendor between incurred claims, 
activities that improve health care quality, and non-claims costs. For 
purposes of the MLR calculation, the commenter is correct that only 
vendors that provide claims adjudication activities need to supply the 
data to the managed care plan in accordance with the timeframes in 
Sec.  438.8(k)(3). The proposed regulatory text referred to third party 
vendors that provide services to enrollees rather than vendors that 
provide claims adjudication activities. We have clarified the 
regulatory text in this final rule accordingly. We encourage states and 
managed care plans to consider

[[Page 27533]]

receiving additional information from other subcontractors that perform 
utilization management and other activities, such as network 
development, for purposes of oversight, data validation, rate setting, 
and encounter data submission activities that are the responsibility of 
the state and/or managed care plan.
    Comment: We received several comments that urged CMS and states to 
provide strong oversight of the MLR provisions to ensure that the 
benefits of applying the MLR requirement are realized.
    Response: We agree with commenters that oversight of the MLR 
provision in the final rule will be necessary to ensure managed care 
plan compliance with the federal minimum standards. Oversight 
protections are built into this final rule, including CMS' review and 
approval of managed care plan contracts as well as CMS' review and 
approval of the rate certifications for consistency with Sec.  
438.4(b)(8) (redesignated in the final at Sec.  438.4(b)(9)). In 
conjunction with the review of the rate certification, we will review 
the state's summary description of the MLR reports under Sec.  
438.74(a). States may want to consider confirming managed care plans' 
compliance with Sec.  438.8(k)(1)(xi) (reconciliation of the MLR with 
the audited financial report) to ensure the amounts in the numerator 
and denominator are accurate and appropriate.
    Comment: Several commenters requested that CMS require either the 
states or the managed care plans to publicly report MLR experience. 
Other commenters requested that CMS publish the MLR calculations in a 
centralized location.
    Response: We agree that MLR experience may be important information 
for potential enrollees when selecting a managed care plan and may be 
of interest to other parties. In Sec.  438.66(e), we require that 
states develop an annual assessment on the performance of their managed 
care program(s). This assessment includes reporting on the financial 
performance of each MCO, PIHP and PAHP as required by Sec.  
438.66(e)(2)(i). To clarify that requirement, we are finalizing Sec.  
438.66(e)(2)(i) with an explicit reference to MLR experience. States 
will be required to publish the assessment annually on their Web sites. 
At this time, we do not intend to publish these annual performance 
assessments on www.Medicaid.gov, but may consider doing so in the 
future if we determine it would be beneficial to the Medicaid program.
    Comment: One commenter recommended that CMS require the MLR to be 
measured and reported by managed care plans for the first year of 
participation in a managed care program, which is contrary to the 
proposal at Sec.  438.8(l). The commenter stated that reporting of the 
MLR experience in the first year of the managed care plan's operation 
in a state should be required even though such experience would not 
have been considered in the development of the capitation rates for the 
first contract year. Alternatively, another commenter requested that 
CMS exempt managed care plans from calculating and reporting a MLR for 
the first 2 years of operation in a state's managed care program in 
order to allow the population in the managed care plan to stabilize.
    Response: We proposed in Sec.  438.8(l), and finalize here, that 
states have the discretion to exclude a newly contracted managed care 
plan from the MLR calculation and reporting requirements in Sec.  438.8 
for the first contract year. We do not agree that it should be a 
federal requirement that the MLR be calculated and reported by a 
managed care plan for the first year of operation in a state's managed 
care program. Such a requirement could cause confusion for enrollees or 
other stakeholders and lead them to believe that the managed care plan 
is not operating efficiently. There are many start up activities and 
expenses that managed care plans incur in the first year of operation 
that are not ongoing after start-up; we do not want states, enrollees, 
or other stakeholders to assume that a managed care plan is not 
operating efficiently when, in fact, administrative costs may level out 
in future years of operation. States may impose an MLR calculation and 
reporting requirement through the contract for a managed care plan's 
first year of operation, but that decision will remain at the state's 
discretion.
    While we understand that the utilization of some covered 
populations may not be completely stabilized in the second year of 
operation, the over-inflation of startup costs will be mitigated at 
that point. Therefore, we do not believe a change is necessary to 
exempt a managed care plan from calculating and reporting the MLR in 
the second year so that such experience may be taken into account when 
developing actuarially sound capitation rates in accordance with Sec.  
438.4(b)(8) (redesignated in the final at Sec.  438.4(b)(9)).
    Comment: One commenter requested that CMS specify that where a new 
population is added to the contract, the administrative costs 
associated with adding that population be excluded from the MLR 
calculation for the year prior to the new population being added. 
Additionally, a few commenters requested a modification that allows a 
managed care plan that expanded to a new geographic region to consider 
the experience of the enrollees in the new region as newer experience 
under Sec.  438.8(l) and, therefore, be permitted to exclude that 
experience in their MLR calculation and reporting.
    Response: We believe these commenters are seeking guidance and 
revision of Sec.  438.8(l). We do not believe that adding a new 
population or geographic region under the contract should exempt a 
managed care plan from the MLR calculation and reporting requirement. 
We note that other commenters expressed concern over the difficulty 
with separating administrative functions by covered population; 
therefore, we are concerned that the managed care plan may find the 
commenter's suggestion that the administrative costs associated with a 
new population be excluded from the MLR calculation administratively 
burdensome. We disagree with the premise of these comments that adding 
new covered populations or service areas will skew MLR calculation and 
reports; we believe that there are limited additional expenses in these 
situations because the managed care plan is already in operation within 
the state.
    Comment: One commenter requested that recalculations due to 
retroactive changes to capitation rates be limited to only once per MLR 
reporting year to avoid administrative burden on the managed care 
plans.
    Response: With the changes in these rules related to retroactive 
rate changes in Sec.  438.7(c)(2), we believe that the number and scope 
of retroactive changes to capitation rates will significantly decrease. 
Those changes will likely achieve the result the commenter sought and 
we are not making changes to the MLR provisions.
    Comment: We received a comment recommending that CMS form a 
workgroup of states, actuaries, and managed care plan representatives 
to work through technical corrections necessary for the MLR 
requirement.
    Response: We have addressed technical corrections in this final 
rule. In the event additional technical corrections are necessary, we 
will issue such a correction through the Federal Register.
    Comment: One commenter noted that in the preamble to the proposed 
rule, CMS did not correctly reference the appropriate CFR citation for 
the Medicare MLR rules and the sentence appeared to indicate that the 
Medicare

[[Page 27534]]

MLR rules are in 45 CFR when in fact they are in 42 CFR.
    Response: The commenter is correct that the Medicare rules for MLR 
are found at 42 CFR 422.2400 and 423.2400 and the private rules are 
found in 45 CFR part 158.
    After consideration of the public comments and for the reasons 
discussed above, we are finalizing Sec.  438.8 with the following 
changes from the proposed rule:
     Changed the definition of MLR reporting year in Sec.  
438.8(a) to reference the new definition of rating period.
     Modified definitions in Sec.  438.8(b) to insert ``MLR'' 
for ``medical loss ratio'' for consistency within Sec.  438.8.
     Modified the definition of ``non-claims costs'' in Sec.  
438.8(b) to refer to ``activities that improve health care quality'' 
for consistency with Sec.  438.8(e)(3).
     Deleted designations for paragraphs (1) and (2) from Sec.  
438.8(d).
     Removed the term ``medical'' from Sec.  438.8(e)(2)(i)(A) 
when referencing ``services meeting the requirements of Sec.  
438.3(e).''
     Revised Sec.  438.8(e)(2)(i)(B) to reference claims 
``liabilities'' instead of claims ``reserves '' and to include amounts 
incurred but not reported.
     Revised Sec.  438.8(e)(2)(ii)(A) to refer to ``network 
providers'' instead of ``health care professionals'' as we are not 
finalizing a definition for ``health care professional'' and are adding 
a definition for ``network provider.''
     Revised Sec.  438.8(e)(2)(ii)(B) to reference pharmacy 
rebates received and accrued as part of incurred claims and deleted 
``MCO, PIHP, or PAHP'' as all aspects of the MLR calculation are based 
on the expenses of the MCO, PIHP, or PAHP and a specific reference is 
not needed in this paragraph.
     Deleted Sec.  438.8(e)(2)(ii)(C) related to state 
subsidies for stop-loss payment methodologies.
     Deleted Sec.  438.8(e)(2)(iii)(A) related to payments made 
by the MCO, PIHP, or PAHP to mandated solvency funds.
     Changed Sec.  438.8(e)(2)(iii)(B), redesignated as Sec.  
438.8(e)(2)(iii)(A), to include amounts expected to be paid to network 
providers.
     To accommodate other modifications to proposed Sec.  
438.8(e)(2)(iii), the cross reference to paragraph (C) has been updated 
to paragraph (B).
     Redesignated Sec.  438.8(e)(2)(iii)(C) as Sec.  
438.8(e)(2)(iii)(B), in light of the deletion of the proposed Sec.  
438.8(e)(2)(iii)(A) related to payment by the MCO, PIHP, or PAHP to 
mandated solvency funds.
     Revised Sec.  438.8(e)(2)(iv) to include or deduct, 
respectively, net payments or receipts related to state mandated 
solvency funds. To accommodate other modifications to proposed Sec.  
438.8(e)(2)(iv), paragraphs (A) and (B) were deleted.
     Excluded amounts from the numerator for pass-through 
payments under to Sec.  438.6(d) in Sec.  438.8(e)(2)(v)(C).
     Revised Sec.  438.8(e)(4) to allow the Medicaid MLR 
numerator to include fraud prevention activities according to the 
standard that is adopted for the private market at 45 CFR part 158.
     Excluded amounts for pass-through payments made under to 
Sec.  438.6(d) from the denominator in Sec.  438.8(f)(2)(i).
     Revised Sec.  438.8(f)(2)(iii) to exclude payments 
authorized by Sec.  438.6(b)(2) from the denominator.
     Added local taxes as an item that can be deducted from 
premium revenue in Sec.  438.8(f)(3)(iv).
     Changed the treatment of risk sharing mechanisms as 
proposed at Sec.  438.8(e)(2)(iv)(A), which was revised to reference 
risk-sharing mechanisms broadly, to the denominator at Sec.  
438.8(f)(2)(vi).
     Removed designations for paragraphs (1) and (2) from Sec.  
438.8(i).
     Changed the term ``reconcile'' to ``compare'' in Sec.  
438.8(k)(1)(xi).
     Revised Sec.  438.8(k)(3) to refer to third party vendors 
that provide claims adjudication services.
(3) State Requirements (Sec.  438.74)
    We proposed minimum standards for state oversight of the MLR 
standards in Sec.  438.74. Specifically, we proposed two key standards 
related to oversight for states when implementing the MLR for 
contracted MCOs, PIHPs, and PAHPs: (1) Reporting to CMS; and (2) re-
payment and reporting of the federal share of any remittances the state 
chooses to collect from the MCOs, PIHPs, or PAHPs. Proposed paragraph 
(a) required each state to provide a summary description of the MLR 
calculations for each of the MCOs, PIHPs, and PAHPs with the rate 
certification submitted under Sec.  438.7. Proposed paragraph (b) 
applied if the state collects any remittances from the MCOs, PIHPs, or 
PAHPs for not meeting the state-specified minimum MLR standard. In such 
situations, we proposed that the state would return the federal share 
and submit a report describing the methodology for how the state 
determined the federal share. We explained that if a state decided not 
to segregate MLR reporting by population, the state would need to 
submit to CMS the methodology of how the federal share of the 
remittance was calculated that would be reviewed and approved via the 
normal CMS-64 claiming protocol.
    We received the following comments in response to our proposal to 
revise Sec.  438.74.
    Comment: Many commenters supported proposed Sec.  438.74(a)(1) and 
(2) while other commenters recommended that CMS include additional 
requirements. Several commenters recommended that CMS include 
requirements for states to submit the actual MLR reports received from 
MCOs, PIHPs, and PAHPs in addition to the summary description and that 
such information be made public. Commenters also recommended that CMS 
establish a dedicated public Web site to provide states with an MLR 
reporting template, including instructions and definitions to improve 
the uniformity of MLR data and information.
    Response: We believe that the availability of MLR information will 
help beneficiaries make more informed choices among managed care plans. 
We believe that the summary report as proposed provides enough 
information at the time of submission. If it is found that more 
information on the specific managed care plan's MLR is necessary, CMS 
may ask the state for it at the time of actuarial certification review. 
As noted previously, we believe that we have provided for adequate 
public display of the MLR information through Sec.  438.66 and expect 
the financial experience of each of the managed care plans, including 
their MLRs, to be reported annually and posted to the state's public 
Web site. We do not intend to post these on a CMS-hosted Web site at 
this time.
    Comment: A few commenters had concerns regarding proposed Sec.  
438.74(a)(1) and (2). One commenter stated that section Sec.  
438.5(b)(5) requires states to consider MLRs when developing rates, and 
as such, it is not necessary to coordinate the delivery of the MLR 
report with the actuarial certification as proposed in section Sec.  
438.74(a)(1). The commenter recommended that CMS clarify that section 
Sec.  438.74(a)(1) does not mandate consideration of a single, two-
year-old MLR report when setting current capitation rates. The 
commenter instead recommended that the MLR reports be submitted as part 
of the annual report required by section Sec.  438.66(e). One commenter 
expressed its concern that CMS would publish MLRs from all Medicaid 
managed care plans and draw conclusions about how efficiently states 
are operating their managed care programs. The commenter recommended 
that CMS should not

[[Page 27535]]

publish such information without a discussion regarding the significant 
variation across states, including for taxes and program design.
    Response: Because we will use the calculated MLR summary report in 
the review of the rate certification for actuarial capitation rates, we 
believe that a submission of the summary report is important to provide 
when submitting the actuarial certification for review and approval. 
Section 438.4(b)(8) (redesignated in the final at Sec.  438.4(b)(9)), 
requires that one criterion for the development of actuarially sound 
capitation rates is that the capitation rate be developed in such a 
manner that the managed care plan could reasonably achieve an MLR of at 
least 85 percent. The MLR summary report for each managed care plan 
under Sec.  438.74(a) is one source to be used to meet that criterion.
    We do not intend to publish the MLR experience of each managed care 
plan of each state publically at this time, but we do expect the states 
to do so as part of its public annual report as required in Sec.  
438.66(e).
    Comment: A few commenters supported proposed Sec.  438.74(b)(1) and 
(2), which would require states to reimburse CMS for the federal share 
of any MLR remittances and to submit a report on the methodology used 
to calculate the state and federal share of such remittances. A few 
commenters recommended that CMS provide further guidance regarding how 
states should develop the methodology for how the federal share of the 
remittance was calculated or recommended that CMS clarify whether 
states have the flexibility to develop this methodology independently. 
These commenters also requested guidance on the timeframe within which 
the FFP would be required to be returned to CMS after a state collected 
a remittance.
    Response: States have the flexibility to determine how to aggregate 
the data across the managed care plan contract for purposes of 
calculating the MLR. Consequently, there could be several methodologies 
used to calculate the amount of the federal share of a remittance. 
Consistent with the processes for CMS-64 reporting, the state would 
submit the methodology for determining the federal share of the 
remittance to CMS for review. States should return the federal share by 
the end of the following quarter in which the remittance was received.
    Comment: One commenter recommended that CMS take a proactive 
approach in monitoring the requirements proposed at Sec.  438.74. The 
commenter recommended that CMS be prescriptive about how states approve 
and audit managed care plan calculations and reports. The commenter 
recommended that CMS audit state criteria and data every 2 years.
    Response: As we intend to review the summary data submitted by the 
state with the actuarial certifications we believe that we will have 
sufficient ability to question the state about how they instructed 
their managed care plans to complete the calculation, as well as about 
the outcomes of these calculations. We do not intend to complete audits 
at this time, but may consider it in the future if we find it would 
benefit the program.
    After consideration of the public comments, we are finalizing Sec.  
438.74 as proposed with the following modifications:
     Inserted ``rate'' in place of ``actuarial'' in Sec.  
438.74(a) to describe the certification in Sec.  438.7 and rephrased 
the last half of the sentence to improve the accuracy of cross-
references.
     Inserted ``the amount of the'' preceding ``denominator'' 
and replace ``MLR experienced'' with ``the MLR percentage achieved'' in 
Sec.  438.74(a)(2) to improve readability.
     Inserted ``separate'' before ``report'' in Sec.  
438.74(b)(2) to clarify that, if a remittance is owed according to 
paragraph (b)(1), the state must submit a separate report from the one 
required under paragraph (a) to describe to methodology for determining 
the state and federal share of the remittance.
I.B.2. Standard Contract Provisions (Sec.  438.3)
    We proposed to add a new Sec.  438.3 to contain the standard 
provisions for MCO, PIHP, and PAHP contracts, including non-risk PIHPs 
and PAHPs, that are distinguishable from the rate setting process and 
the standard provisions that apply to PCCM and PCCM entity contracts. 
These provisions generally set forth specific elements that states must 
include in their managed care contracts, identify the contracts that 
require CMS approval, and specify which entities may hold comprehensive 
risk contracts. To improve the clarity and readability of part 438, we 
proposed that Sec.  438.3 would include the standard contract 
provisions from current Sec.  438.6 that are unrelated to standards for 
actuarial soundness and the development of actuarially sound capitation 
rates.
    We proposed that the provisions currently codified in Sec.  438.6 
as paragraphs (a) through (m) be redesignated respectively as Sec.  
438.3(a) through (l), (p) and (q), with some revisions as described 
below. These proposed paragraphs addressed standards for our review and 
approval of contracts, entities eligible for comprehensive risk 
contracts, payment, prohibition of enrollment discrimination, services 
covered under the contract, compliance with applicable laws and 
conflict of interest safeguards, provider-preventable conditions, 
inspection and audit of financial records, physician incentive plans, 
advance directives, subcontracts, choice of health professional, 
additional rules for contracts with PCCMs, and special rules for 
certain HIOs.
    a. CMS Review (Sec.  438.3(a))
    First, in Sec.  438.3(a) related to our review and approval of 
contracts, we proposed to add the regulatory flexibility for us to set 
forth procedural rules--namely timeframes and detailed processes for 
the submission of contracts for review and approval--in sub-regulatory 
materials, and added a new standard for states seeking contract 
approval prior to a specific effective date that proposed final 
contracts must be submitted to us for review no later than 90 days 
before the planned effective date of the contract. Under our proposal, 
the same timeframe would also apply to rate certifications, as proposed 
Sec.  438.7(a) incorporated the review and approval process of Sec.  
438.3(a). To the extent that the final contract submission is complete 
and satisfactory responses to questions are exchanged in a timely 
manner, we explained that we expected 90 days would be a reasonable and 
appropriate timeframe for us to conduct the necessary level of review 
of these documents to verify compliance with federal standards. Upon 
approval, we would authorize FFP concurrent with the contract effective 
date. In addition, for purposes of consistency throughout part 438, we 
proposed to remove specific references to the CMS Regional Offices and 
replace it with a general reference to CMS; we also noted our 
expectation that the role of the CMS Regional Offices would not change 
under the proposed revisions to part 438.
    We received the following comments in response to proposed Sec.  
438.3(a).
    Comment: Several commenters sought clarification or objected to the 
proposal in Sec.  438.3(a) that the state submit contracts, and rate 
certifications based on the cross-reference in Sec.  438.7(a), to CMS 
for review and approval no later than 90 days before the effective date 
of the contract if the state sought approval by the effective date of 
the contract. Some commenters were supportive of Sec.  438.3(a) and 
suggested that CMS

[[Page 27536]]

extend the timeframe from 90 days to 180 days. Many commenters were 
concerned that the provision did not require CMS to complete review and 
approval within the 90 day timeframe and recommended that such 
requirements be imposed on CMS. A few commenters raised the issue that 
this provision would require prior approval of all contract types 
including PIHPs and PAHPs when the statute requires prior approval of 
MCO contracts only. Some commenters were concerned about the capacity 
for CMS to complete the review of contracts and rate certifications 
within 90 days. In addition, a few commenters suggested timeframes for 
the regulation, ranging from 15 to 45 days, by which CMS would take 
action on the contract and alert the state to any compliance issues to 
permit states time to remedy such issues before the effective date of 
the contract, or requested that CMS adopt a process similar to that 
used for State plan amendments. Some commenters suggested that we 
remove this provision from the final rule in light of the provision at 
Sec.  438.807 that would permit partial deferral or disallowances and 
recommended that CMS continue to work with states on standard operating 
procedures for the approval of contracts and rate certifications. A few 
commenters were concerned that a requirement for the state to submit 
the rate certification at least 90 days prior to the effective date of 
the contract would result in the actuary relying on older data for rate 
setting purposes and requested that the rate certification be submitted 
at least 45 days for the effective date of the contract.
    Response: As Sec.  438.3(a) also applies to rate certifications 
under Sec.  438.7(a), we address both contract and rate submissions in 
this response to comments. Commenters have misinterpreted the intention 
and scope of the 90 day timeframe in proposed (and finalized) in Sec.  
438.3(a). The text provides that the 90 day requirement applies to 
those states that seek approval of the contract prior to its effective 
date. We are aware that some states, through application of state law 
or long-standing policies, are required to have CMS approval prior to 
the effective date of the contract, while other states do not operate 
under similar requirements and may move forward with implementing the 
contract without CMS approval at the point of the effective date. In 
the former situation, states have submitted contracts and rate 
certifications to CMS shortly before the effective date and have urged 
CMS to conduct the necessary diligent level of review within a 
constrained timeframe. This provision seeks to modify that practice. 
However, we believe that CMS approval of contracts and rate 
certifications prior to the effective date of the contract is a good 
business practice and would eliminate uncertainty and potential risk to 
the states and managed care plans that operate with unapproved 
contracts and rates. We recognize that this has not been a customary or 
usual practice and that states would have to modify their contracting 
and rate setting timeframes to submit this documentation to us 90 days 
prior to the effective date of the contract. In recognition of the 
administrative activities that would need to be modified in some 
states, we purposefully limited the requirement in Sec.  438.3(a) to 
those states that seek approval prior to the effective date of the 
contract either through state law or policy. In that context, we stated 
in the proposed rule (80 FR 31114) that 90 days is a reasonable 
timeframe for CMS to complete that task assuming that the contracts and 
rate certifications are compliant with federal requirements; we decline 
to extend it to 180 days as some commenters suggested. We have internal 
standard operating procedures and resources dedicated to the review of 
contracts and rate certifications and will continue to monitor the 
effectiveness of those procedures to ensure that we are effective 
partners in this process. Further, approval of the contract and rate 
certification is necessary prior to the payment of FFP claimed on the 
CMS-64.
    In regard to commenters' concerns as to how this provision relates 
to partial deferrals or disallowances in proposed Sec.  438.807, that 
proposal (discussed below in section I.B.4.e) was to authorize us to 
take a partial deferral or disallowance when we find non-compliance on 
specific contractual or rate setting provisions. We did not propose to 
extend Sec.  438.807 to contractual or rate setting provisions for 
which we have not completed our review; further this comment is moot in 
light of our decision with regard to Sec.  438.807, as discussed in 
detail in section I.B.4.e. We decline to establish regulatory 
timeframes for CMS to finalize or notify the state of compliance 
issues; we also decline to adopt a deemed approval approach if the 90 
days elapse without approval because this provision is not directly 
tied to the prior approval requirements in Sec.  438.806.
    We disagree with commenters that requested a 45 day timeframe for 
the submission of rate certifications to mitigate concerns about the 
actuary relying on older data for rate setting purposes to meet the 90 
day timeframe. Section 438.5(c)(2) would require states and their 
actuaries to use appropriate base data with the data being no older 
than the 3 most recent and complete years prior to the rating period. 
The additional claims data that would be used in a rate development 
process that would accommodate a 45 day timeframe for submission to 
CMS, rather than a 90 day timeframe, is not actuarially significant.
    Comment: A few commenters objected to the provision in paragraph 
(a) that CMS reserved the ability to establish the form and manner of 
contract submissions through sub-regulatory guidance rather than 
through regulation. Since the regulatory language is vague, commenters 
stated it would be difficult to determine whether the state could meet 
this requirement and that such formatting requirements may conflict 
with state procurement and contract standards.
    Response: As stated in the proposed rule (80 FR 31114), we proposed 
to reserve the flexibility set forth procedural rules--namely 
timeframes and processes for the submission of contracts for review and 
approval--in subregulatory materials. The substantive standards and 
requirements about the content of the contract and rate certifications 
are established in this final rule. We do believe that a standard 
operating procedure for the submission process would benefit all 
involved parties. We acknowledge that states and Medicaid managed care 
plans have concerns about the process and procedure for these 
submissions and intend to use a collaborative process, to the extent 
feasible, in the development and finalization of our procedures.
    Comment: A commenter requested clarification whether the contract 
submitted for CMS review must be signed and fully executed.
    Response: Under this rule, we will permit a state to submit a 
complete, non-executed contract so long as the signature pages are 
provided sufficiently ahead of time (and not accompanied by material 
changes to the contract) for CMS conduct our review.
    Comment: Some commenters requested that providers have the ability 
to issue comments on the managed care contracts before they are 
approved by CMS through a public review and comment period.
    Response: We acknowledge the valuable input that providers and 
other stakeholders have to offer to inform the development of a state's 
managed care program and that public notice and engagement requirements 
could

[[Page 27537]]

facilitate involvement of providers and stakeholders. However, the 
direct parties to the contracting process are the State and the managed 
care plans; we do not agree that it is reasonable or appropriate for us 
to institute a federal requirement for public comment on the managed 
care contracts.
    After consideration of the public comments, we are finalizing 
438.3(a) as proposed.
b. Entities Eligible for Comprehensive Risk Contracts (Sec.  438.3(b))
    We proposed to redesignate the existing provisions at Sec.  
438.6(b) to Sec.  438.3(b), without substantive change. We did not 
receive comments on Sec.  438.3(b) pertaining to entities that are 
eligible for comprehensive risk contracts and will finalize as 
proposed.
c. Payment (Sec.  438.3(c))
    In proposed Sec.  438.3(c), we restated our longstanding standard 
currently codified at Sec.  438.6(c)(2)(ii) that the final capitation 
rates for each MCO, PIHP, or PAHP must be specifically identified in 
the applicable contract submitted for our review and approval. We also 
proposed to reiterate in this paragraph that the final capitation rates 
must be based only upon services covered under the state plan and that 
the capitation rates represent a payment amount that is adequate to 
allow the MCO, PIHP, or PAHP to efficiently deliver covered services in 
a manner compliant with contractual standards.\3\
---------------------------------------------------------------------------

    \3\ We note that in Medicaid and Children's Health Insurance 
Programs; Mental Health Parity and Addiction Equity Act of 2008; the 
Application of Mental Health Parity Requirements to Coverage Offered 
by Medicaid Managed Care Organizations, the Children's Health 
Insurance Program (CHIP), and Alternative Benefit Plans final rule 
published March 30, 2016 (81 FR 18390), we clarified that certain 
additional costs could also be used to develop capitation rates. 
That provision would be codified as part of Sec.  438.6(e) and 
redesignated through this final rule as Sec.  438.3(e)).
---------------------------------------------------------------------------

    We received the following comments in response to Sec.  438.3(c).
    Comment: One commenter noted that states may cover services in 
addition to the state plan (for example, home and community based 
services) and suggested that distinguishing between State plan services 
and other waiver services for purposes of capitation payments is 
unnecessary.
    Response: We clarify here that services approved under a waiver 
(for example, sections 1915(b)(3) or 1915(c) of the Act) are considered 
State plan services and are encompassed in the reference to ``State 
plan services'' in Sec.  438.3(c). Therefore, Sec.  438.3(c) does not 
need to distinguish them.
    Comment: A couple of commenters requested clarification that Sec.  
438.3(c) and Sec.  438.3(e) were consistent with section 3.2.5 of the 
Actuarial Standard of Practice (ASOP) No. 49.
    Response: We maintain that Sec.  438.3(c) and (e) in this final 
rule are consistent with ASOP No. 49. Section 3.2.5 of ASOP No. 49 is 
entitled ``covered services'' and provides the following: ``When 
developing capitation rates under Sec.  438.6(c), the actuary should 
reflect covered services for Medicaid beneficiaries, as defined in the 
contract between the state and the MCOs, which may include cost 
effective services provided in lieu of state plan services. When 
developing capitation rates for other purposes, the actuary should 
reflect the cost of all services, including enhanced or additional 
benefits, provided to Medicaid beneficiaries.'' (emphasis added). We 
note that comments about in lieu of services are addressed below in 
connection with Sec.  438.3(e); that section as finalized is consistent 
with the section 3.2.5 of ASOP No. 49. Section 3.2.5 of ASOP No. 49 
distinguishes between developing capitation rates under Sec.  438.6(c) 
(redesignated as 438.3(c) in this final rule) and developing capitation 
rates for other purposes. An actuary may develop and set two rates--one 
that includes only the Medicaid covered services under the contract 
(for example, state plan services and in lieu of services generally), 
which is described in the first sentence, and the other could include 
services not covered by Medicaid. Only capitation payments developed in 
accordance with Sec.  438.3(c) are eligible for FFP. We also note that 
Sec.  438.3(c) also directs that capitation rates under this section be 
based upon and include services that are necessary for compliance with 
mental health parity requirements; those requirements are discussed in 
the Medicaid and Children's Health Insurance Programs; Mental Health 
Parity and Addiction Equity Act of 2008; the Application of Mental 
Health Parity Requirements to Coverage Offered by Medicaid Managed Care 
Organizations, the Children's Health Insurance Program (CHIP), and 
Alternative Benefit Plans final rule which published in the March 30, 
2016 Federal Register (81 FR 18390) (the March 30, 2016 final rule).
    Since publication of the proposed rule, we have become aware of 
instances in a couple of states where capitation payments were made for 
enrollees that were deceased and the capitation payments were not 
recouped by the state from the managed care plans. It is unclear to us 
why such capitation payments would be retained by the managed care 
plans as these once Medicaid-eligible enrollees are no longer Medicaid-
eligible after their death. It is implicit in the current rule, and we 
did not propose to change, that capitation payments are developed based 
on the services and populations that are authorized for Medicaid 
coverage under the state plan which are covered under the contract 
between the state and the managed care plan and that capitation 
payments are made for Medicaid-eligible enrollees. This would not 
include deceased individuals or individuals who are no longer Medicaid-
eligible. Therefore, we are including language in Sec.  438.3(c) to 
specify that capitation payments may only be made by the state and 
retained by the MCO, PIHP or PAHP for Medicaid-eligible enrollees. As a 
corollary of this requirement and while we assume that states and 
managed care plans already operate in such a manner, we advise states 
to have standard contract language that requires individuals that are 
no longer Medicaid-eligible to be disenrolled from the managed care 
plan.
    To effectuate the change to Sec.  438.3(c), introductory text is 
added following the ``Payment'' heading for paragraph (c) that the 
requirements apply to the final capitation rate and the receipt of 
capitation payments under the contract. A new designation for paragraph 
(1) specifies that the final capitation rate for each MCO, PIHP or PAHP 
must be (i) specifically identified in the applicable contract 
submitted for CMS review and approval and (ii) the final capitation 
rates must be based only upon services covered under the State plan and 
additional services deemed by the state to be necessary to comply with 
the parity standards of the Mental Health Parity and Addiction Equity 
Act, and represent a payment amount that is adequate to allow the MCO, 
PIHP or PAHP to efficiently deliver covered services to Medicaid-
eligible individuals in a manner compliant with contractual 
requirements. The requirements in finalized paragraphs (c)(1)(i) and 
(ii) mirror those that were proposed at Sec.  438.3(c). A new paragraph 
(2) specifies that capitation payments may only be made by the state 
and retained by the MCO, PIHP or PAHP for Medicaid-eligible enrollees 
to address the issue of retention of capitation payments for Medicaid 
enrollees that have died, or who are otherwise no longer eligible.
    After consideration of the comments, we are finalizing Sec.  
438.3(c) with a new paragraph (c)(2) to make clear that capitation 
payments may not be made by the state and retained by the managed care 
plan for Medicaid enrollees that have died, or who are

[[Page 27538]]

otherwise no longer Medicaid-eligible and with non-substantive 
revisions to clarify text.
d. Enrollment Discrimination Prohibited (Sec.  438.3(d))
    We proposed to redesignate the provisions prohibiting enrollment 
discrimination currently at Sec.  438.6(d) as new Sec.  438.3(d) and 
proposed to replace the reference to the Regional Administrator with 
``CMS''; this replacement was for consistency with other proposals to 
refer uniformly to CMS as one entity in the regulation text. We also 
proposed to add sex, sexual orientation, gender identity and disability 
as protected categories under our authority in section 1902(a)(4) of 
the Act; this proposal related to sex discrimination is discussed in 
the proposed changes in Sec.  438.3(f) below.
    We received the following comments on proposed Sec.  438.3(d).
    Comment: Several commenters supported Sec.  438.3(d)(4) which would 
prohibit enrollment discrimination against individuals eligible to 
enroll on the basis of race, color, national origin, sex, sexual 
orientation, gender identity or disability. Many commenters suggested 
that CMS include individuals in the criminal justice system to the list 
of categories for which enrollment discrimination is prohibited.
    Response: We appreciate commenters support for the inclusion of 
sex, sexual orientation, gender identity or disability as protected 
classes for purposes of prohibiting discrimination in enrollment. We 
note that our proposed rule discussed, in connection with Sec. Sec.  
438.206 and 440.262 (discussed in section I.B.6.a. below), the basis 
for inclusion of these new categories in the anti-discrimination 
standards. We believe that the obligation for the state plan to promote 
access and delivery of services without discrimination is necessary to 
assure that care and services are provided in a manner consistent with 
the best interest of beneficiaries under section 1902(a)(19) of the 
Act. Prohibiting a managed care plan from discriminating in enrollment 
on these bases is necessary to ensure access and provision of services 
in a culturally competent manner. We believe that the best interest of 
beneficiaries is appropriately met when access to managed care 
enrollment (as well as access to services themselves) is provided in a 
non-discriminatory manner; adopting these additional methods of 
administration is also necessary for the proper operation of the state 
plan under section 1902(a)(4) of the Act. However, we decline to 
include individuals in the criminal justice system to Sec.  438.3(d). 
First, neither that classification nor anything related to it are 
specified in the statutory authorities underlying this provision. 
Second, we do not believe that the same justification exists for adding 
the other categories, namely assurance of the provision of services in 
a culturally competent manner and assurance that care and services are 
provided in a manner consistent with the best interests of 
beneficiaries, applies to the category of individuals in the criminal 
justice system. We believe that the regulation as proposed and as 
finalized on this point is adequate.
    After consideration of public comment, we are finalizing Sec.  
438.3(d) as proposed.
e. Services That May Be Covered by an MCO, PIHP, or PAHP (Sec.  
438.3(e))
    The current regulation at Sec.  438.6(e) addresses the services 
that may be covered by the MCO, PIHP, or PAHP contract. We proposed to 
move that provision to Sec.  438.3(e). The existing provision also 
prohibits services that are in addition to those in the Medicaid state 
plan from being included in the capitation rate and we proposed to 
incorporate that standard in new Sec.  438.3(c).
    We received the following comments on proposed Sec.  438.3(e).
    Comment: Several commenters requested that CMS specify requirements 
for in lieu of services in regulation.
    Response: We agree that clarifying and codifying in regulation the 
requirements for the provision of in lieu of services is appropriate. 
Our proposed rule (80 FR 31116-31117) discussed the long-standing 
policy on in lieu of services; although that was in the context of our 
proposal related to payment of capitation payments for enrollees who 
spend a period of time as patients of an institution for mental 
disease, our proposal identified when in lieu of services are 
appropriate generally and several commenters raised the topic. In 
finalizing Sec.  438.3(e), we are including regulation text in a new 
paragraph (2) to identify when and which services may be covered by an 
MCO, PIHP, or PAHP in lieu of services that are explicitly part of the 
state plan. If a state authorizes the use of in lieu of services under 
the contract in accordance with Sec.  438.3(e)(2), the managed care 
plan does not have to use in lieu of services as the introductory 
language at paragraph (e)(2) specifies that the MCO, PIHP, or PAHP may 
voluntarily use in lieu of services. In addition, if the managed care 
plan wants to use the in lieu of services authorized and identified in 
the contract, an enrollee cannot be required to use the in lieu of 
service. Specifically, the new regulation imposes four criteria for in 
lieu of services under the managed care contract. First, in paragraph 
(e)(2)(i), the state would determine that the alternative service or 
setting is a medically appropriate and cost effective substitute for 
the covered service or setting under the state plan as a general 
matter. Because the in lieu of service is a substitute setting or 
service for a service or setting covered under the state plan, the 
determination must be made by the state that the in lieu of service is 
a medically appropriate and cost effective substitute as a general 
matter under the contract, rather than on an enrollee-specific basis. 
This authorization is expressed through the contract, as any contract 
that includes in lieu of services must list the approved in lieu of 
services under paragraph (e)(2)(iii). Under paragraph (e)(2)(ii), the 
enrollee cannot be required by the MCO, PIHP, or PAHP to use the 
alternative service or setting. In paragraph (e)(2)(iii), the approved 
in lieu of services are authorized and identified in the MCO, PIHP, or 
PAHP contract and are offered at the managed care plans' discretion, 
which is a corollary of paragraph (e)(2)(i). In paragraph (e)(2)(iv), 
the utilization and cost of in lieu of services are taken into account 
in developing the component of the capitation rates that represents the 
covered state plan services. This means that the base data capturing 
the cost and utilization of the in lieu of services are used in the 
rate setting process. This paragraph also specifies that this approach 
applies unless statute or regulation specifies otherwise (such as how 
Sec.  438.6(e) relating to the use of services in an IMD as an in lieu 
of service requires a different rate setting approach). Additional 
discussion of in lieu of services is in provided in response to 
comments under section I.B.2.s., regarding the provision proposed at on 
Sec.  438.3(u) (finalized and redesignated at Sec.  438.6(e)) relating 
to capitation payments for enrollees with a short term stay in an IMD.
    After consideration of public comments, we are finalizing Sec.  
438.3(e) with additional text to address requirements for the use of in 
lieu of services in managed care. First, the introductory text from 
proposed paragraph (e) is redesignated at paragraph (e)(1), without 
substantive change, and the paragraphs proposed as (e)(1) and (e)(2) 
(Reserved) are redesignated as (e)(1)(i) and (e)(1)(ii) in this final 
rule. Second, we are codifying

[[Page 27539]]

the requirements for coverage and provision of services in lieu of 
state plan services as paragraph (e)(2). In addition, we are 
redesignating and replacing provisions at Sec.  438.6(e) finalized in 
the March 30, 2016 final rule (81 FR 18390), as follows: Sec.  
438.6(e)(1) is redesignated and replaced as Sec.  438.3(e)(1)(ii) with 
the text at Sec.  438.6(e)(1)(ii), and Sec.  438.6(e)(2) and Sec.  
438.6(e)(3) (pertaining to services a managed care plan voluntarily 
provide and treatment of such services in rate setting) is redesignated 
and replaced Sec.  438.3(e)(1)(i).
f. Compliance With Applicable Laws and Conflict of Interest Safeguards 
(Sec.  438.3(f))
    We also proposed to redesignate the existing standard for 
compliance with applicable laws and conflict of interest standards from 
existing Sec.  438.6(f) to Sec.  438.3(f)(1) with the addition of a 
reference to section 1557 of the Affordable Care Act, which prohibits 
discrimination in health programs that receive federal financial 
assistance. We also proposed to add sex as a protected category for 
purposes of MCO, PIHP, PAHP, PCCM, or PCCM entity enrollment practices 
in the enrollment provisions proposed to be moved to Sec.  438.3(d)(4), 
because adding this category is consistent with the scope of section 
1557 of the Affordable Care Act. We also proposed to add sexual 
orientation and gender identity because managed care plans are 
obligated to promote access and delivery of services without 
discrimination and must ensure that care and services are provided in a 
manner consistent with the best interest of beneficiaries under section 
1902(a)(19) of the Act. We noted that the best interest of 
beneficiaries is appropriately met when access is provided in a non-
discriminatory manner; adopting these additional methods of 
administration is also necessary for the proper operation of the state 
plan under section 1902(a)(4) of the Act.
    In addition, we proposed a new standard, at Sec.  438.3(f)(2), to 
state more clearly the existing requirement that all contracts comply 
with conflict of interest safeguards (described in Sec.  438.58 and 
section 1902(a)(4)(C) of the Act).
    We received the following comments in response to proposed Sec.  
438.3(f).
    Comment: A few commenters stated that contracts with managed care 
plans must specify how the managed care plan will comply with the 
Americans with Disabilities Act (ADA) and the Olmstead vs. L.C. Supreme 
Court decision. A few commenters wanted CMS to add an explicit 
reference to the Olmstead vs. L.C. decision into the regulation, while 
other commenters recommended there should be a requirement that managed 
care plans rebalance their institutional and home and community based 
services so that individuals show a trend of moving from the 
institution to the community.
    Response: We maintain that a reference to the ADA in regulation is 
sufficient as there may be other court decisions relevant to LTSS over 
time and we believe that identifying just one decision in the 
regulation that interprets the ADA could have an unintended limiting 
effect. We support rebalancing of HCBS and deinstitutionalization of 
persons when possible and encourage states in their efforts to comply 
with Olmstead and the ADA. After consideration of the public comments, 
we are finalizing Sec.  438.3(f) as proposed.
g. Provider-Preventable Condition Requirements (Sec.  438.3(g))
    We proposed to redesignate the standards related to provider 
reporting of provider-preventable conditions currently codified in 
Sec.  438.6(f)(2)(i) to the new Sec.  438.3(g). With this 
redesignation, we proposed to limit these standards to MCOs, PIHPs, and 
PAHPs, because those are the entities for which these standards are 
applicable. We did not receive comments on the proposals related to 
reporting of provider-preventable conditions at Sec.  438.3(g) and will 
finalized as proposed.
h. Inspection and Audit of Records and Access to Facilities (Sec.  
438.3(h))
    We proposed to move the inspection and audit rights for the state 
and federal government from Sec.  438.6(g) to new Sec.  438.3(h) and to 
expand the existing standard to include access to the premises, 
physical facilities and equipment of contractors and subcontractors 
where Medicaid-related activities or work is conducted. In addition, we 
proposed to clarify that the state, CMS, and the Office of the 
Inspector General may conduct such inspections or audits at any time.
    We received the following comments in response to proposed Sec.  
438.3(h).
    Comment: Several commenters recommended that CMS specify at Sec.  
438.3(h) that audits will be coordinated to eliminate duplication and 
disruption of services and care. Commenters recommended that CMS 
include language in the final rule to identify how many inspections may 
be conducted in a contract year to minimize the frequency of 
unnecessary or duplicative audits.
    Response: We decline to adopt commenters' recommendations at Sec.  
438.3(h) as we do not believe it is appropriate to arbitrarily set a 
maximum number of audits or inspections that may be conducted in a 
contract year, particularly when audits could have different focus and 
scope. We agree with commenters that audits should be coordinated when 
possible and as appropriate but decline to modify the proposed 
regulatory text to impose that as a requirement. We believe that 
efforts to coordinate audits and inspections should be considered at an 
operational level.
    Comment: One commenter recommended that CMS require a Medicaid 
auditing project officer at Sec.  438.3(h) to closely monitor auditors 
and identify issues within the auditing process and resolve those 
issues in a timely manner. The commenter also recommended that the 
project manager should serve as a point of contact to providers and be 
readily accessible to work with providers to address any concerns that 
the provider cannot resolve directly with the auditor.
    Response: We decline to adopt the commenter's recommendation to 
require a Medicaid auditing project officer or project manager. We do 
not believe it is appropriate to include this operational consideration 
in federal regulation; rather, states could consider this as part of 
their auditing structure for state conducted audits.
    Comment: One commenter recommended that CMS clarify at Sec.  
438.3(h) that audits may not look-back to exceed 18 months after a 
claim is adjudicated. The commenter stated that this approach would 
reduce the administrative burden of research on providers.
    Response: We decline to adopt the commenter's recommendation to 
limit audits to 18 months after a claim is adjudicated. Under the False 
Claims Act at 31 U.S.C. 3731(b)(2), claims may be brought up to 10 
years after the date on which a violation is committed. For 
clarification, we are adding the right to audit of 10 years provided in 
Sec.  438.230(c)(3)(iii) to Sec.  438.3(h) so that the timeframe is 
clear for managed care plans, PCCMs, and PCCM entities in Sec.  
438.3(h), as well as for subcontractors of MCOs, PIHPs, PAHPs, and PCCM 
entities in Sec.  438.230.
    Comment: One commenter recommended that CMS define ``at any time'' 
and ``Medicaid-related activities'' at Sec.  438.3(h). One commenter 
stated concern that Sec.  438.3(h) and Sec.  438.230(c)(3)(i) do not 
align regarding audits that may occur ``at any time'' or audits that 
may occur when ``the

[[Page 27540]]

reasonable possibility of fraud is determined to exist,'' respectively. 
The commenter recommended that CMS clarify this discrepancy.
    Response: The phrase ``at any time'' in Sec.  438.3(h) means that 
the specified entities may inspect and audit records and access 
facilities of the MCO, PIHP, PAHP, PCCM, PCCM entity or subcontractors 
outside of regular business hours and such access is not conditioned on 
the reasonable possibility of fraud. The phrase ``Medicaid-related 
activities'' means any business activities related to the obligations 
under the Medicaid managed care contract. Because Sec. Sec.  438.3(h) 
and 438.230(c)(3)(i) address the inspection and audit of the managed 
care plans (and PCCM entities and PCCMs) and their subcontractors, 
respectively, we will revise Sec.  438.230(c)(3)(i) to indicate that 
audits and inspections may occur at any time.
    Comment: A few commenters recommended that CMS clarify the list of 
entities that may inspect and audit in Sec.  438.3(h). One commenter 
recommended that CMS specifically include ``State MFCU'' in the list. 
One commenter recommended that CMS include the list at Sec.  
438.230(c)(3)(i), which includes ``designees.''
    Response: We agree with commenters that Sec. Sec.  438.3(h) and 
438.230(c)(3)(i) should be consistent regarding the list of entities 
that may inspect and audit. Therefore, we will revise Sec.  438.3(h) to 
include the list at Sec.  438.230(c)(3)(i), including the Comptroller 
General and designees of the listed federal agencies and officials.
    After consideration of the public comments, we are modifying the 
regulatory text at Sec.  438.230(c)(3)(i) to indicate that audits and 
inspections may occur at any time to be consistent with Sec.  438.3(h). 
We are modifying the regulatory text at Sec.  438.3(h) to include the 
list at Sec.  438.230(c)(3)(i), including the Comptroller General and 
designees. We are also adding the right to audit for 10 years to Sec.  
438.3(h) so that the timeframe is clear and consistent for managed care 
plans, PCCMs, and PCCM entities in Sec.  438.3(h), as well as for 
subcontractors of MCOs, PIHPs, PAHPs, and PCCM entities in Sec.  
438.230. We are otherwise finalizing Sec.  438.3(h) as proposed.
i. Physician Incentive Plans (Sec.  438.3(i))
    As part of our proposal to redesignate the provisions related to 
physician incentive plans from Sec.  438.6(h) to new Sec.  438.3(i), we 
proposed to correct the outdated references to Medicare+Choice 
organizations to MA organizations.
    We received the following comments on the regulation text 
concerning physician incentive plans at Sec.  438.3(i).
    Comment: One commenter encouraged CMS to allow the development of 
incentive plans for physicians and physician groups that are aligned 
with achieving goals for improving quality and efficiency of care 
delivery.
    Response: Section 438.3(i) is based on section 1903(m)(2)(A)(x) of 
the Act, which requires physician incentive plans to comply with the 
requirements for physician incentive plans at section 1876(i)(8) of the 
Act, which have been implemented at Sec.  417.479 of this chapter for 
reasonable cost plans and made applicable to MA organizations at Sec.  
422.208 of this chapter. To ensure that the identical requirements are 
made applicable to MCOs under section 1903(m)(2)(A)(x) of the Act and 
PIHPs and PAHPs under section 1902(a)(4) of the Act, we have cross-
referenced the MA regulations. These are the only explicit limitations 
on physician incentive programs for network providers and we are 
supportive of managed care plans incentivizing providers to meet 
performance metrics that improve the quality and efficiency of care.
    After consideration of the public comments, we are finalizing Sec.  
438.3(i) as proposed.
j. Advance Directives (Sec.  438.3(j))
    We proposed to redesignate the provisions for advance directives 
currently in Sec.  438.6(i) as Sec.  438.3(j). We received the 
following comments on Sec.  438.3(j) relating to advance directives.
    Comment: Several commenters thought CMS should specify in this 
section of the regulation that there is a prohibition against coercion 
for individuals to sign an advance directive.
    Response: The purpose of this section is for states to require 
managed care plans to have policies in place for advance directives 
when the managed care plan provides for institutional, home-based 
services, and/or LTSS. An identical set of requirements are imposed on 
MA organizations under section 1852(i) of the Act (by way of cross-
reference to section 1866 of the Act) and have been implemented under 
Sec.  422.128. Our regulation, by cross-referencing Sec.  422.128, 
requires the managed care plans to have policies that include written 
information concerning the individual's rights to make decisions 
concerning medical care, to refuse or accept medical or surgical 
treatment, and to formulate advance directives; a prohibition against 
discrimination whether or not the individual chooses to execute an 
advance directive; and provision for individual and community education 
about advance directives. We believe that the regulatory language 
clearly provides for the rights of individuals to make decisions 
concerning medical care and to formulate an advance directive, and we 
are therefore not modifying Sec.  438.3(j).
    After consideration of the public comments, we are finalizing Sec.  
438.3(j) with ``as if such regulation applied directly to . . .'' in 
paragraphs (1) and (2) and ``subject to the requirements of this 
paragraph (j) . . .'' in paragraph (3) for clarification.
k. Subcontracts (Sec.  438.3(k))
    We proposed to redesignate the provisions for subcontracts 
currently at Sec.  438.6(l) as Sec.  438.3(k) and also proposed to add 
a cross-reference to Sec.  438.230 that specifies standards for 
subcontractors and delegation. We did not receive comments on Sec.  
438.3(k) and will finalize as proposed.
l. Choice of Health Professional (Sec.  438.3(l))
    We proposed to redesignate the standards for choice of health care 
professional currently at Sec.  438.6(m) at Sec.  438.3(l).
    We received the following comments on the standards for choice of 
health professional at Sec.  438.3(l). We did not propose any 
substantive change to the current rule other than this redesignation.
    Comment: One commenter supported Sec.  438.3(l) regarding the 
choice of health professional. One commenter disagreed with the 
provision and stated that the provision would limit managed care plans 
from guiding enrollees to lower-cost and higher-quality providers. The 
commenter stated that it would also be more difficult to transition 
enrollees from a provider that is exiting the program. The commenter 
further stated that CMS should prohibit enrollees from insisting on 
services delivered by a specific provider when the managed care plan 
has offered the enrollee the services of a qualified provider who is 
available to provide the needed services.
    Response: We disagree with the commenter that Sec.  438.3(l) limits 
managed care plans from guiding enrollees to lower-cost and higher-
quality providers. Section Sec.  438.3(l) requires that the contract 
must allow each enrollee to choose his or her health professional to 
the extent possible and appropriate. If a provider is exiting the 
program, it would not be possible or appropriate to allow an enrollee 
to choose that specific health professional. We also decline to 
generally prohibit

[[Page 27541]]

enrollees from insisting on services delivered by a specific network 
provider when the managed care plan has offered the enrollee the 
services of another qualified provider who is available to provide the 
needed services. We believe this statement is overly broad and could 
vary greatly depending on the contract and the services being 
requested. The 2001 proposed rule, finalized in 2002, incorporated this 
section directly from Sec.  434.29, which addressed contract 
requirements for health maintenance organizations (see 66 FR 43622).
    In addition, this section uses the term ``health professional'' 
which is not currently defined in part 438. We address our proposal 
related to adding a definition for health care professional in section 
I.B.9.a. of this final rule. We have changed the term ``health 
professional'' to ``network provider'' in this final rule to clarify 
that the choice for enrollees is within the network.
    After consideration of the public comments, we are finalizing Sec.  
438.3(l) with a modification to replace ``health professional'' with 
``network provider'' in the heading and text.
m. Audited Financial Reports (Sec.  438.3(m))
    In Sec.  438.3(m), we proposed to add a new standard that MCOs, 
PIHPs, and PAHPs submit audited financial reports on an annual basis as 
this information is a source of base data that must be used for rate 
setting purposes in proposed Sec.  438.5(c). We proposed that the 
audits of the financial data be conducted in accordance with generally 
accepted accounting principles and generally accepted auditing 
standards.
    We received the following comments on proposed Sec.  438.3(m).
    Comment: Several commenters supported Sec.  438.3(m) regarding 
annual audited financial reports. A few commenters recommended that CMS 
limit duplicative requirements for submission of such audited financial 
reports. Specifically, one commenter recommended that CMS permit 
managed care plans to submit previously audited financial reports. One 
commenter recommended that CMS align the federal requirement to provide 
audited financial reports with any state requirement to provide audited 
financial reports to state licensing authorities. One commenter 
recommended that CMS clarify whether such audited financial reports 
must be specific to the Medicaid contract.
    Response: We clarify for commenters that managed care plans must 
submit audited financial reports on an annual basis in accordance with 
generally accepted accounting principles and generally accepted 
auditing standards. Audited financial reports are a source of base data 
for purposes of rate setting at Sec.  438.5(c) and such information 
must be provided to the state for such purposes. We encourage states to 
coordinate submission deadlines or other requirements with similar 
requirements for state licensing agencies, as appropriate, to mitigate 
duplicative reporting requirements. We proposed a general standard at 
Sec.  438.3(m) to ensure that states had this information on an annual 
basis and it would be impracticable for us to attempt to align the 
federal requirement with each state's requirement to provide audited 
financial reports to state licensing authorities. We intend the 
requirement in Sec.  438.3(m) to be that the MCO, PIHP, or PAHP submit 
annual audited financial reports specific to the Medicaid contract(s), 
not to other lines of business or other plans administered or offered 
by the entity. We are adding text to the final rule to make this clear.
    Comment: One commenter recommended that CMS include regulatory text 
at Sec.  438.3(m) to prohibit states and managed care plans from using 
any audit program that bases its audited financial reports on 
extrapolation. The commenter recommended that CMS require states to 
develop standards and guidelines for managed care audits of financial 
reports that will ensure that all Medicaid audits of financial reports 
are conducted using generally accepted auditing standards and in 
accordance with state and federal law.
    Response: We decline to adopt the commenter's recommendation. We 
have already provided at Sec.  438.3(m) that audits of financial 
reports must be conducted in accordance with generally accepted 
accounting principles and generally accepted auditing standards. We 
believe that such standards are adequate for this purpose and that 
additional requirements are unnecessary.
    Comment: One commenter recommended that CMS define ``audited 
financial report'' at Sec.  438.3(m). The commenter recommended that 
CMS clarify the term and encourage state-arranged audits of program-
specific financial results. The commenter recommended that states be 
given some degree of discretion in selecting appropriate approaches to 
Medicaid financial data verification, while upholding a vigorous and 
professional methodology. The commenter also recommended that the 
emphasis on Generally Accepted Accounting Principles (GAAP) be 
tempered. The commenter stated that many costs that are completely 
acceptable and allowable under GAAP are not allowable under Federal 
Acquisition Regulations (FAR). The commenter recommended that CMS allow 
flexibility for states in this regard. The commenter stated that CMS 
can mandate GAAP as a floor for audited financial reports but should 
also recognize the significance of FAR. The commenter recommended that 
states with more rigorous methods, such as cost principles that extend 
the concepts of FAR into specifics pertaining to capitated managed 
care, should be able to continue to utilize those methods. Finally, the 
commenter recommended that CMS clarify the sufficiency of whether 
states can utilize a desk review of financial data submitted by managed 
care plans for certain limited purposes when audited financial reports 
are not yet available.
    Response: We decline to adopt a definition for ``audited financial 
report'' as these reports are part of the normal course of business 
within the health insurance industry and do not require further federal 
definition. We clarify for the commenter that nothing at Sec.  438.3(m) 
prevents the state from utilizing state-arranged audits of program-
specific financial results or selecting appropriate approaches to 
Medicaid financial data verification. We also clarify that Sec.  
438.3(m) does not preclude states from requiring managed care plans to 
apply the principles in the FAR in the auditing of financial reports. 
Generally, professional standards of practice acknowledge the effect of 
state or federal laws that may differ from the standards of practice. 
However, it is not clear to us how the FAR would directly impact the 
auditing of financial reports in this context. Finally, we clarify that 
states may utilize a desk review of financial data submitted by managed 
care plans for certain limited purposes when audited financial reports 
are not yet available with appropriate documentation.
    After consideration of the public comments, we are finalizing all 
Sec.  438.3(m) largely as proposed, with a modification to add the 
phrase ``specific to the Medicaid contract'' to clarify the scope of 
the audited financial report.
    Paragraph (n) was reserved in the proposed rule and is finalized as 
a redesignation of Sec.  438.6(n) in the March 30, 2016 final rule (81 
FR 18390).
n. LTSS Contract Requirements (Sec.  438.3(o))
    In Sec.  438.3(o), we proposed that contracts covering LTSS provide 
that services that could be authorized through a waiver under section 
1915(c) of the Act or a state plan amendment

[[Page 27542]]

through section 1915(i) or 1915(k) of the Act be delivered consistent 
with the settings standards in Sec.  441.301(c)(4).
    We received the following comments on the proposal to add Sec.  
438.3(o).
    Comment: A number of commenters supported proposed Sec.  438.3(o) 
that services that could be in a sections 1915(c), (i), or (k) of the 
Act authorized program delivered under managed care must meet the 
requirements of the home and community-based services regulation at 
Sec.  441.301(c)(4) of this chapter, although a couple commenters noted 
the challenges posed by the HCBS settings requirements in that section. 
Many commenters thought that CMS should amend Sec.  438.3(o) to include 
a transition period for settings to become compliant as is found in the 
HCBS regulation for existing programs.
    Response: We appreciate the support for this provision and 
recognize the challenges posed by the HCBS settings requirements. The 
authority for a managed care delivery system is in conjunction with the 
authorities underlying LTSS, such as programs operating under sections 
1915(c), (i), or (k) of the Act. The transition period specified in the 
HCBS final rule (79 FR 2948) for states to comply with the settings 
requirements at Sec.  441.301(c)(4) for programs existing prior to 
March 17, 2014 would similarly apply to an MLTSS program that is 
subject to this requirement under Sec.  438.3(o) as we view that 
transition period as a substantive part of Sec.  442.301(c)(4) for 
purposes of applying those standards under Sec.  438.3(o). We clarify 
that the intent of Sec.  438.3(o) was to incorporate and apply the 
settings requirements at Sec.  441.301(c)(4) (directly regulating 
Medicaid FFS) for LTSS in MLTSS programs.
    After consideration of the public comments, we are finalizing Sec.  
438.3(o) as proposed.
o. Special Rules for Certain HIOs (Sec.  438.3(p))
    We proposed to redesignate existing Sec.  438.6(j) (special rules 
for certain HIOs) as Sec.  438.3(p). As part of our proposed 
redesignation of the HIO-specific provisions from existing Sec.  
438.6(j) to new Sec.  438.3(p), we also proposed to correct a cross-
reference in that paragraph.
    We received the following comments on the HIO-specific provisions 
at Sec.  438.3(p).
    Comment: One commenter stated that Sec.  438.3(p) did not clearly 
explain when HIOs are subject to the provisions of part 438 and when 
they are exempt. The commenter stated that Title XIX of the Act only 
exempts a narrow subset of HIOs from the rules that apply to other 
capitated managed care plans. The commenter recommended that CMS 
clarify that exempt HIOs are subject to the same rules as other 
capitated managed care plans, except where exemptions specific to the 
HIO's special features apply. The commenter recommended that CMS amend 
this section to omit reference to non-exempt HIOs and instead clarify 
that exempt HIOs must meet all provisions of part 438 except those to 
which they are explicitly exempted.
    Response: This long-standing provision should be read in 
conjunction with the definition of an HIO in Sec.  438.2 and we direct 
the commenter to 67 FR 40994 for a discussion of the HIOs that are 
exempt from section 1903(m)(2)(A) of the Act. Basically, a county-
operated organization that would meet the definition of a comprehensive 
risk contract and does not meet the definition of an HIO in Sec.  438.2 
is an MCO that is subject to all provisions that apply to MCOs in this 
part.
    After consideration of the public comments, we are finalizing 
438.3(p) as proposed with a modification to correct the cross-reference 
to paragraph (b) of Sec.  438.3.
p. Additional Rules for Contracts With PCCMs and PCCM Entities (Sec.  
438.3(q) and (Sec.  438.3 (r))
    We proposed to redesignate the additional contract standards 
specific to PCCM contracts from existing Sec.  438.6(k) to new Sec.  
438.3(q) to separately identify them. In Sec.  438.3(r), we proposed to 
set standards for contracts with PCCM entities, in addition to those 
standards specified for PCCM contracts in proposed Sec.  438.3(q), 
including the submission of such contracts for our review and approval 
to ensure compliance with Sec.  438.10 (information requirements). If 
the PCCM entity contract provides for shared savings, incentive 
payments or other financial reward for improved quality outcomes, Sec.  
438.330 (performance measurement), Sec.  438.340 (managed care elements 
of comprehensive quality strategy), and Sec.  438.350 (external quality 
review) would also be applicable to the PCCM entity contract. We 
address comments on Sec.  438.3(q) and (r) at section I.B.6.e of this 
final rule.
q. Requirements for MCOs, PIHPs, or PAHPs That Provide Covered 
Outpatient Drugs (Sec.  438.3(s))
    In Sec.  438.3(s), we proposed that state Medicaid contracts with 
MCOs, PIHPs, or PAHPs meet the requirements of section 1927 of the Act 
when providing coverage of covered outpatient drugs. The proposed 
managed care standards are based primarily on section 
1903(m)(2)(A)(xiii) of the Act and we relied on our authority under 
section 1902(a)(4) of the Act to extend the section 1927 requirements 
to PIHPs and PAHPs that are contractually obligated to provide covered 
outpatient drugs. In addition, we relied on section 1902(a)(4) of the 
Act to address, for all managed care plans within the scope of this 
proposal, requirements that are outside the scope of section 
1903(m)(2)(A)(xiii) of the Act, namely the proposed requirements at 
Sec.  438.3(s)(1), (4) and (6).
    Section 2501(c)(1)(C) of the Affordable Care Act amended section 
1903(m)(2)(A) of the Act to add clause (xiii) to add certain standards 
applicable to contracts with MCOs. In the February 1, 2016 Federal 
Register (81 FR 51700, we published the ``Medicaid Program; Covered 
Outpatient Drugs'' final rule which included the definition for covered 
outpatient drugs in Sec.  447.502. We have incorporated the appropriate 
definitions in Sec.  447.502 related to covered outpatient drugs in 
part 438.3(s).
General Comments (Sec.  438.3(s))
    We received the following comments about proposed Sec.  438.3(s) 
generally.
    Comment: A few commenters requested that the states be allowed 12 
months from the effective date of the final rule to implement the 
provisions proposed in Sec.  438.3(s). The commenters specifically 
referenced the requirements to identify 340B drug utilization, 
implement the formulary and prior authorization requirements, amend 
contracts, and develop DUR programs, as tasks contributing to the need 
for an extended implementation.
    Response: As specified in the effective and compliance date 
sections of this final rule, states and managed care plans will have 
until contracts starting on or after July 1, 2017 to come into 
compliance with the provisions of Sec.  438.3(s).
    Comment: One commenter stated that the proposed rule should exclude 
hospital covered outpatient drugs from the Medicaid Drug Rebate program 
if the hospital bills Medicaid for covered outpatient drugs at no more 
than the hospital's purchasing costs per section 1927(j)(2) of the Act.
    Response: Nothing in proposed Sec.  438.3(s) changes the exemption 
found at section 1927(j)(2) of the Act from the requirements in section 
1927 of the Act. Therefore, hospitals that dispense covered outpatient 
drugs using drug formulary systems and bill the managed care plan no 
more than the hospital's purchasing costs for covered outpatient

[[Page 27543]]

drugs would not be subject to the rebate requirements of section 1927 
of the Act.
    Comment: One commenter urged CMS to require states to develop 
provisions that would not only ensure enrollee choice, but would also 
prohibit managed care plans from imposing financial incentives for the 
use of mail order pharmacy services.
    Response: We decline to implement the commenter's suggestion. While 
we agree that enrollee access and freedom of choice is essential, 
managed care plans may contract with mail order pharmacies in an effort 
to control costs and support enrollee compliance with medication 
therapies. If a managed care plan requires an enrollee to use a mail 
order pharmacy for maintenance or other appropriate medication 
therapies, that information should be in the member handbook or other 
appropriate informational materials to aid in the enrollee's choice of 
a managed care plan.
    Comment: One commenter suggested that states and managed care plans 
should properly define specialty drugs and that states should develop 
standards on how managed care plans determine which drugs are included 
on specialty drugs lists. The commenter suggested a definition of 
specialty drug, as well as what are considered to be key policy 
principles that should be followed to ensure that specialty drugs are 
properly defined and categorized. In part, the commenter indicated that 
specialty drugs should not be subject to requirements or limitations 
that would require specialty drugs to be delivered through mail order 
or a restricted network; the definition should not be based solely on 
cost and should focus on the clinical aspect of the drugs; the 
definition should require that all drugs under consideration meet the 
listed criteria before being added to a specialty drug lists; and the 
definition should ensure stakeholders have sufficient advance notice 
of, and an opportunity to review and comment on, mail order only drugs 
lists, and to receive a written explanation of the reasons for the 
limitation of where such drugs may be dispensed.
    Response: While we appreciate this comment and recognize the need 
for consistency in the use of terms within the healthcare industry, we 
believe it is beyond the scope of this final rule for CMS to adopt a 
specific definition of specialty drug or to require states to develop 
standards on how managed care plans define specialty drugs.
    Comment: A few commenters had suggestions regarding requirements 
that CMS should place on managed care plan payments to providers and 
pharmacies and pricing methodologies. One commenter stated that managed 
care plans should be required in their contracts with their pharmacies 
to clearly define drug pricing methodologies, routinely update drug 
pricing, pay pharmacies promptly, and allow pharmacies to contest 
changes in their reimbursement. The commenter believed that including 
such requirements would encourage pharmacy participation, which would 
result in increased access and options for Medicaid beneficiaries. 
Another commenter requested that CMS require states to ensure that 
provider payment rates are at levels that help to preserve enrollee 
access once the pharmacy benefit is transitioned from FFS to managed 
care plans. The commenter believed that CMS should require states to 
apply the same level of reassurance and reimbursement protections for 
all participating providers, including pharmacy providers, and that 
establishing a reimbursement rate floor for pharmacies will increase 
transparency as well as allow for fiscal stability and predictability 
of reimbursement in these private contracts. Another commenter 
indicated that CMS should require that managed care plans pay providers 
at least acquisition costs for drugs and that capitation rates be 
appropriately set.
    Response: The payment terms negotiated between a managed care plan 
and its network pharmacies are outside the scope of this final rule and 
part 438 generally. Such payment terms are negotiated as part of the 
contract between the managed care plan and its participating providers. 
Each managed care plan must ensure that its enrollees have access to 
pharmacy services when covered by the Medicaid contract and that the 
pharmacy network is consistent with the access standards for delivery 
networks at Sec.  438.206 and set by the state under Sec.  438.68. We 
strongly encourage managed care plans to consider and treat 
compensation to providers as an important element in developing and 
maintaining adequate and robust networks.
    Comment: One commenter requested that CMS urge states to develop 
rules that would require managed care plans to adequately define when a 
state Maximum Allowable Cost (MAC) list can be established; how such 
lists should be updated and provided to pharmacies; and how a pharmacy 
may challenge a particular rate decision. The commenter also provided 
specific criteria that it believes states should be required to 
consider when establishing its MAC. The commenter recommended that CMS 
require states to incorporate the criteria in their managed care 
contracts. The commenter further stated that requiring fair and 
transparent contractual terms related to pharmacy pricing would benefit 
pharmacy providers, as well as the Medicaid program.
    Response: While we appreciate this comment, the establishment of a 
state MAC is beyond the scope of this final rule.
    Comment: One commenter indicated that the overall cost to dispense 
an over-the-counter (OTC) drug is the same as a prescription drug and 
therefore, urged CMS to require states to implement adequate and fair 
dispensing fees for all managed care claims, including OTC drugs.
    Response: While we appreciate this comment, the dispensing fees 
paid by managed care plans for OTC drugs is part of the contract terms 
negotiated between the managed care plan and the pharmacy. Therefore, 
it is beyond the scope of this final rule.
    Comment: One commenter stated that CMS should encourage states to 
require managed care plans to pay all pharmacy claims in a timely 
manner. The commenter suggested that all Medicaid pharmacy claims 
should follow the current requirements under Medicare Part D which 
require that clean claims submitted electronically should be paid 
within 14 days, and all other clean claims should be paid within 30 
days. The commenter also suggested that managed care plans should be 
required to submit payment via Electronic Funds Transfer (EFT), if 
requested by provider, and at no charge to the provider. The commenter 
also stated that managed care plans should be required to pay interest 
for late payments, and have procedures in place to correct defective or 
unclean claims.
    Response: Section 1932(f) of the Act incorporates the timely claim 
payment provisions in section 1902(a)(37)(A), which are specified in 
regulation at Sec.  447.46. That regulation permits an alternative 
payment schedule if the managed care plan and provider agree. If a 
managed care plan contracts with a pharmacy benefit manager (PBM) for 
the pharmacy benefit, the provisions of section 1932(f) of the Act, 
governing prompt and timely payments by MCOs, still apply.
    Comment: One commenter expressed concern regarding the lack of 
requirements around payment file updates for physician-administered 
drugs. The commenter requested that CMS consider requiring states to 
implement a quarterly requirement to update payment files to mirror 
Medicare

[[Page 27544]]

Part B, and provide an oversight plan for monitoring these important 
updates.
    Response: While we appreciate this comment, payment file dates for 
physician-administered drugs is beyond the scope of this final rule.
    Comment: One commenter urged CMS to clarify in the final rule that 
all Medicaid managed care plans must meet MH/SUD parity requirements 
related to prescription drugs for MH/SUD conditions.
    Response: We appreciate the opportunity to clarify that all 
requirements related to MHPAEA under managed care were codified in 
subpart K of part 438 of the March 30, 2016 final rule (81 FR 18390). 
We do not believe a duplicative reference in Sec.  438.3(s) is 
necessary.
    Comment: One commenter recommended that CMS provide technical 
guidance to pharmacies, managed care plans, and other entities 
participating in care delivery that will result in all parties using a 
single, industry-standard code to identify relevant drug claims.
    Response: The comment is outside of the scope of this final rule. 
However, to respond to the commenter's request for an industry standard 
code to identify Medicaid drug rebate claims, CMS requires that states 
provide the National Drug Code when invoicing the manufacturers for 
rebates and reporting utilization to CMS as authorized under section 
1927(b)(2)(A) of the Act.
    Comment: A commenter requested that CMS clarify that the 
requirements at Sec.  438.3(s) do not apply to individuals enrolled in 
programs or plans for dually eligible beneficiaries, as these programs 
traditionally follow Medicare Part D requirements.
    Response: Medicare Part D is responsible for paying for covered 
outpatient drugs dispensed to dual eligible individuals. The 
requirements at Sec.  438.3(s) establish standards for states that 
contract with managed care plans to provide Medicaid coverage of 
covered outpatient drugs; as such, this regulation does not apply to 
covered outpatient drugs for individuals enrolled in Medicare Part D 
plans.
    Comment: Several commenters supported the inclusion of section 1927 
of the Act regarding prescription drug protections in proposed Sec.  
438.3(s), including the prior authorization timeline and that managed 
care plan contracts must cover prescription drugs consistent with 
federal Medicaid requirements. Other commenters urged CMS to simply 
reference the existing requirements under section 1927 of the Act, 
rather than adding confusion to the contract requirements around 
outpatient drugs for managed care plan enrollees.
    Response: We appreciate the support for including clarification in 
Sec.  438.3(s) around the application of the covered outpatient drug 
requirements in section 1927 of the Act to state contracts with managed 
care plans. We decided not to provide a general reference to section 
1927 of the Act to clarify exactly which drug provisions MCOs, PIHPS, 
and PAHPs must comply with.
Prescription Drug Coverage (438.3(s)(1))
    In paragraph (s)(1), we proposed that the MCO, PIHP, or PAHP must 
provide coverage of covered outpatient drugs (as defined in section 
1927(k)(2) of the Act) as specified in the contract and in a manner 
that meets the standards for coverage of such drugs imposed by section 
1927 of the Act as if such standards applied directly to the MCO, PIHP, 
or PAHP. Under the proposal, when the MCO, PIHP, or PAHP provides 
prescription drug coverage, the coverage of such drugs must meet the 
standards set forth in the definition of covered outpatient drugs at 
section 1927(k)(2) of the Act. The MCO, PIHP, or PAHP may be permitted 
to maintain its own formularies for covered outpatient drugs, but when 
there is a medical need for a covered outpatient drug that is not 
included in their formulary but that is within the scope of the 
contract, the MCO, PIHP, or PAHP must cover the covered outpatient drug 
under a prior authorization process. This proposal was based on our 
authority under section 1902(a)(4) of the Act to mandate methods of 
administration that are necessary for the efficient operation of the 
state plan. Furthermore, if an MCO, PIHP, or PAHP is not contractually 
obligated to provide coverage of a particular covered outpatient drug, 
or class of drugs, the state is required to provide the covered 
outpatient drug through FFS in a manner that is consistent with the 
standards set forth in its state plan and the requirements in section 
1927 of the Act.
    We received the following comments on proposed Sec.  438.3(s)(1).
    Comment: Several commenters asked that we remove or reframe the 
language related to outpatient drug coverage at Sec.  438.3(s)(1); the 
commenters said that existing regulation (Sec.  438.210) requires 
managed care plans to provide benefits consistent with the state plan. 
Therefore, the commenters believed that Sec.  438.3(s)(1) could be 
duplicative. The commenters were concerned that the inclusion of this 
language in the proposed regulation could inadvertently limit states' 
actions around prior authorization and off-label use of outpatient 
drugs, as well as shift costs onto the state. Commenters also indicated 
that the requirement under scope of coverage at Sec.  438.210 between 
managed care programs and FFS is sufficient to ensure members have the 
same access to benefits, including prescription drug coverage.
    Response: While the requirement at Sec.  438.210 has been in place 
for some time, we believe some states have not adequately addressed 
these requirements in their contracts with managed care plans and are 
clarifying in this regulation the specific requirements that either the 
state, or the managed care plan, must adopt to ensure the availability 
of, and access to, equivalent covered outpatient drug services 
consistent with applicable law. Therefore, we generally agree that the 
requirements of this final regulation are not necessarily new to states 
and believe that these requirements should not necessitate a major 
overhaul of their programs or managed care contracts. We further note 
that states may continue to adopt prior authorization processes 
consistent with the minimum requirements at section 1927(d)(5) of the 
Act and provide covered outpatient drugs for medically accepted 
indications as defined in section 1927(k)(6) of the Act.
    Comment: Commenters requested that CMS be very clear what a state 
is responsible for paying for versus the managed care plan, and 
requested clarification on how it is determined to be ``within the 
scope of the contract'' but not in the formulary. Commenters stated if 
a managed care plan is not contractually obligated to provide coverage 
of a particular covered outpatient drug, or class of drugs, the state 
is required to provide the covered outpatient drug through FFS in a 
manner that is consistent with the standards set forth in its state 
plan and the requirement in section 1927 of the Act. These commenters 
asked CMS to clarify if this applies only when the drug is already 
covered under Medicaid FFS, or if this means that Medicaid must cover 
every drug and, as written, it may make states responsible for FFS 
coverage of managed care covered drugs resulting in cost implications 
for the states. Commenters requested that CMS specify that a managed 
care plan's formulary may not be more restrictive than the comparable 
FFS program to avoid access disparities for individuals in FFS versus 
managed care.
    Response: It is our intent to clarify contractual obligations on 
the managed care plan for covered outpatient drugs when this benefit is 
provided by the managed care plan under the contract

[[Page 27545]]

with the state. We consider ``within the scope of the contract'' to be 
the terms negotiated between the state and the managed care plan to 
administer the covered outpatient drug benefit to enrollees. States 
must ensure that when the managed care plan provides covered outpatient 
drugs to enrollees, such services that are available under the state 
plan are available and accessible to enrollees of managed care plans 
consistent with section 1903(m)(1)(A)(i) of the Act. How such services 
are made available to enrollees (either via the contract with the 
managed care plan or directly by the state) are negotiated between the 
state and the managed care plan.
    We understand that each state may cover outpatient drugs 
differently for its managed care enrollees. For example, a state may 
contract with a managed care plan to include coverage of a limited set 
of drugs related to a specific disease state (for example, medications 
for substance abuse disorders). In these instances, the managed care 
plan should meet the coverage requirements of section 1927 of the Act 
to the extent they apply to the drugs covered by the plan within the 
scope of its contract. In other words, a managed care plan that agrees 
to provide coverage of a subset of covered outpatient drugs under the 
contract with the state would need to provide coverage of every covered 
outpatient drug included in the subset when the manufacturer of those 
drugs has entered into a rebate agreement with the Secretary. For 
example, if the managed care plan is only required in its contract to 
provide coverage of substance use disorder drugs, the managed care plan 
may choose to subject certain substance use disorder covered outpatient 
drugs to prior authorization as long as the prior authorization program 
it adopts meets the requirements in section 1927(d)(5) of the Act. 
Further, the state would be required, under section 1927 of the Act, to 
provide coverage of outpatient covered drugs that are not included in 
the managed care plan's contract and the state may meet this obligation 
through FFS or another delivery system.
    States that contract with managed care plans to cover outpatient 
drugs for the entire covered outpatient drug benefit under the state 
plan must ensure that the contract meets the standards set forth at 
Sec.  438.3(s) for all of those drugs. That is, when applicable, the 
managed care plan's contract must ensure that:
     The managed care plan's drugs are covered outpatient drugs 
in accordance with section 1927(k)(2) of the Act and meet the standards 
for coverage under section 1927 of the Act;
     The managed care plan reports drug utilization data to the 
states to enable billing for Medicaid drug rebates;
     The managed care plan has procedures in place to exclude 
utilization data for covered outpatient drugs that are subject to 340B 
discounts covered by the managed care plan;
     The managed care plan operates a drug utilization program 
that complies with the requirements of section 1927(g) of the Act, 
provides a description of the DUR activities to the state on an annual 
basis, and conducts a prior authorization program, when applicable, 
consistent with the minimum requirements set forth at section 
1927(d)(5) of the Act.
    States may allow managed care plans to use their own formulary; 
however, if the managed care plan's formulary does not include a 
covered outpatient drug that is otherwise covered by the state plan 
pursuant to section 1927 of the Act, the managed care plan must ensure 
access to the off-formulary covered outpatient drug consistent with the 
prior authorization requirements at section 1927(d)(5) of the Act. 
States may also choose to cover covered outpatient drugs not on the 
managed care plan's formulary for enrollees by providing coverage of 
such drugs under the state plan using a prior authorization program 
that meets the requirements at section 1927(d)(5) of the Act. States 
and managed care plans should address these requirements in their 
contract documents so the responsibilities of each party are clearly 
identified when administering the Medicaid covered outpatient drug 
benefit.
Managed Care Drug Utilization Data Reporting (Sec.  438.3(s)(2))
    In paragraph (s)(2), we proposed to implement section 
1903(m)(2)(A)(xiii)(III) of the Act. Specifically, we proposed that 
MCOs, PIHPs, and PAHPs report drug utilization data necessary for the 
state to submit utilization data under section 1927(b)(2) of the Act 
and within 45 calendar days after the end of each quarterly rebate 
period to ensure that MCO, PIHP, or PAHP data is included in 
utilization data submitted by states to manufacturers. We further 
proposed that such utilization information must include, at a minimum, 
information on the total number of units of each dosage form and 
strength and package size by National Drug Code of each covered 
outpatient drug dispensed or covered by the MCO, PIHP, or PAHP.
    We received the following comments on proposed Sec.  438.3(s)(2).
    Comment: Several commenters recommended that CMS set specific 
deadlines that managed care plans should meet when reporting data 
utilization associated with the requirements of section 1927(b)(1)(A) 
of the Act. One commenter recommended that managed care plans report 
drug utilization data no later than 30 calendar days after the end of 
each quarterly rebate period and include utilization information at a 
minimum, on the total number of units of each dosage form, strength, 
and package size by National Drug Code of each covered outpatient drug 
dispensed or covered by the MCO, PIHP, or PAHP. Another commenter 
disagrees with the proposed timeframe of 45 days because it may not 
give enough time for the states to review the data prior to invoicing 
drug manufacturers for rebates within each quarter. The commenter 
continued that currently in their state, managed care plans must 
provide rebate data to the state within 25 days after the date the 
claim was adjudicated. The commenter believed that by giving managed 
care plans 30 days after the end of the quarter, states would have 
adequate time to load and process the data they get from the managed 
care plans and do pre-invoice editing prior to submitting the invoices 
to manufacturers. The commenter further requested clarification in the 
rule on language that the 45 day period is the maximum the state can 
allow and that the state can require managed care plans to provide the 
data within a period of time that is less than 45 days.
    Response: In accordance with section 1927(b)(2)(A) of the Act, 
states are required to submit utilization data to manufacturers for 
rebates no later than 60 days after the end of each rebate period 
(quarter). The data submitted to manufacturers must include total 
number of units of each dosage form, strength, and package size of each 
covered outpatient drug. The 45 day requirement proposed at Sec.  
438.3(s)(2) is a maximum, and states may require their managed care 
plans to submit their drug utilization data on any time frame up to 45 
calendar days after the end of the quarterly drug rebate period, as 
long as the state meets the 60 day statutory deadline.
    Comment: One commenter supports CMS' proposal to require managed 
care plans to report drug utilization data necessary for the states to 
bill for Medicaid rebates within 45 calendar days after the end of each 
quarterly rebate period, and believed that CMS should also specify that 
managed care plans must report utilization within 45 calendar days 
after the end of the calendar quarter in which the pharmacy was 
reimbursed and that any utilization

[[Page 27546]]

for dates prior to the most recently ended calendar quarter must be 
clearly segregated and marked as a prior quarter adjustment and contain 
the date on which the pharmacy was reimbursed. The commenter believed 
imposing a 45-day time limit for submitting utilization data to the 
state will help to ensure that states submit complete quarterly 
invoices to manufacturers within 60 days after the close of the quarter 
(as section 1927(b)(2)(A) of the Act requires). This in turn will 
provide manufacturers with timely and more complete information 
regarding their Medicaid rebate liability and result in timely rebate 
payments to state Medicaid programs. Another commenter stated that 
their state's managed care contract requires weekly submission of drug 
utilization data and while the managed care contractual requirements 
are aligned with this portion of the proposed regulation, knowing that 
managed care plan utilization data is lagged, CMS should be clear in 
this final rule and explain how this would be measured (for example, 
date of service, date paid to the pharmacy or date paid by the managed 
care plan).
    Response: Section 1927(b)(1)(A) of the Act requires, in part, that 
manufacturers pay rebates on drugs dispensed to individuals enrolled in 
a MCO. Therefore, all managed care plans should report their 
utilization data to the state based upon the quarter in which the drug 
was dispensed (that is, date of service) to the enrollee, as opposed to 
the quarter in which the managed care plan paid the claim. In addition, 
just as states indicate on quarterly rebate invoices when utilization 
data reflects an earlier quarter (that is, a prior quarter adjustment), 
so should the utilization data that a managed care plan submits to the 
state for a paid claim, reflect adjustments to an earlier quarter by 
specifically referencing the earlier quarter/year date of service in 
which the drug was dispensed.
Exclusion of 340B Drug Utilization Data (Sec.  438.3(s)(3))
    In paragraph (s)(3), we proposed that the MCO, PIHP, or PAHP must 
have procedures in place to exclude utilization data for drugs subject 
to discounts under the 340B Drug Pricing Program from the utilization 
reports submitted under proposed paragraph (s)(2). Section 2501(c) of 
the Affordable Care Act modified section 1927(j)(1) of the Act to 
specify that covered outpatient drugs are not subject to the rebate 
requirements if such drugs are both subject to discounts under section 
340B of the PHS Act and dispensed by health maintenance organizations, 
including Medicaid MCOs. In accordance with section 1927(a)(5) of the 
Act, states may not seek rebates with respect to drugs provided by 
covered entities when covered outpatient drugs are purchased at 
discounted 340B prices that are provided to Medicaid beneficiaries. 
Section 1903(m)(2)(A)(xiii)(III) of the Act specifies that MCOs report 
drug utilization data necessary for the state to bill for rebates under 
section 1927(b)(2)(A) of the Act; we extend those obligations to PIHPs 
and PAHPs using our authority under section 1902(a)(4) of the Act. In 
accordance with this provision, MCOs, PIHPs and PAHPs are not 
responsible for reporting information about covered outpatient drugs if 
such drugs are subject to discounts under section 340B of the PHS Act 
and dispensed by MCOs in accordance with section 1927(j)(1) of the Act. 
Therefore, covered outpatient drugs dispensed to Medicaid enrollees 
from covered entities purchased at 340B prices, which are not subject 
to Medicaid rebates, should be excluded from managed care utilization 
reports to the state. To ensure that drug manufacturers will not be 
billed for rebates for drugs purchased and dispensed under the 340B 
Drug Pricing Program, MCOs, PIHPs, or PAHPs must have mechanisms in 
place to identify these drugs and exclude the reporting of this 
utilization data to the state to prevent duplicate discounts on these 
products. Our proposal at Sec.  438.3(s)(3) was designed to address 
this issue.
    We received the following comments on proposed Sec.  438.3(s)(3).
    Comment: Several commenters indicated their concerns regarding the 
necessity of revenue from the 340B program to continue providing needed 
care to patients of 340B covered entities. Specifically, commenters 
stated that for many 340B covered entities, including FQHCs, the 340B 
Drug Discount Program is critical to their financial stability and that 
these entities rely upon the 340B program as a revenue stream to 
provide a safety net for uninsured and underinsured patients. Several 
commenters requested that CMS add language to the preamble and Sec.  
438.3(s) to clarify that neither states nor managed care plans may 
prohibit 340B providers, including hemophilia treatment providers, who 
are in managed care networks from using 340B drugs for their patients 
nor require providers to agree not to use 340B drugs for their patients 
as a condition of participating in a managed care network. One 
commenter asked that CMS protect the right of entities to use 340B 
drugs for managed care enrollees by explicitly acknowledging it in 
Sec.  438.3(s) and by including guidelines and limits for how managed 
care plans can implement this provision.
    Response: We recognize the importance of the 340B program to all 
covered entities. However, part 438 does not address the availability 
of 340B drugs to the Medicaid population or the revenue generated for 
covered entities from the 340B program. Instead, this rule implements 
the requirements of section 1903(m)(2)(A)(xiii)(III) of the Act, which 
provides that MCOs are not responsible for reporting information about 
covered outpatient drugs that are not subject to a Medicaid rebate if 
such drugs are both subject to discounts under section 340B of the PHS 
Act and dispensed by MCOs in accordance with section 1927(j)(1) of the 
Act. The regulation as finalized here requires the contracts between 
managed care plans and states to require the plans to establish 
procedures to exclude the necessary utilization from the reports to the 
state.
    Comment: Several commenters believe that states should be 
prohibited from requiring that their managed care plans pay lower rates 
for drugs purchased by 340B covered entities than for the same drugs 
when purchased by other managed care network providers. Commenters also 
recommend that CMS prohibit managed care plans from using billing 
information obtained from 340B Medicaid claims to reduce reimbursement 
for 340B commercial claims and asked that CMS require that states have 
their managed care plans contract with 340B covered entities on the 
same terms and conditions and at rates that are not less than the rates 
paid to non-covered entities for the same services.
    Response: This regulation does not address managed care payment for 
drugs purchased by 340B covered entities but rather implements the 
requirements of section 1903(m)(2)(A)(xiii)(III) of the Act which 
provides that the MCOs are not responsible for reporting information to 
states about covered outpatient drugs that are not subject to this 
rebate standard if such drugs are both subject to discounts under 
section 340B of PHS Act and dispensed by MCOs in accordance with 
section 1927(j)(1) of the Act. We extend that protection to PIHPs and 
PAHPs using our authority under section 1902(a)(4) of the Act under 
this rule. Reimbursement by managed care plans for drugs dispensed by 
340B covered entities is negotiated between the managed care plans and 
covered

[[Page 27547]]

entities and is outside the scope of this rule.
    Comment: Several commenters made suggestions on how states and 
managed care plans should identify 340B claims. The commenters 
suggested that CMS prohibit managed care plans from requiring 340B 
covered entities to identify 340B claims as it would make it highly 
difficult or impossible for these covered entities and their contract 
pharmacies to use 340B for Medicaid managed care patients. For example, 
commenters commended CMS for not proposing that pharmacies identify 
340B claims at the point-of-sale (POS). They indicated that pharmacies 
that use a virtual 340B inventory normally do not know at the POS if a 
claim is 340B, so requiring pharmacies to identify all 340B drugs at 
POS effectively prohibits these providers from using 340B drugs for 
managed care patients. The commenters support CMS' decision to provide 
flexibility to managed care plans in developing procedures to exclude 
340B drugs from their reports but ask that CMS protect a covered 
entity's right to carve Medicaid managed care drugs in or out by 
explicitly acknowledging the right in Sec.  438.3(s). Commenters 
suggested that CMS provide guidance encouraging states and managed care 
plans to identify 340B claims retrospectively and that such reporting 
should be standardized so covered entities can comply without the need 
to develop a multitude of different methodologies.
    Other commenters suggested that assigning unique Bank 
Identification Number (BIN)/Processor Control Number (PCN)/Group 
numbers for Medicaid managed care plans will allow pharmacies to 
clearly identify and handle Medicaid managed care claims and enable 
pharmacies dispensing 340B drugs to distinguish these claims from the 
managed care commercial claims for covered drugs. In addition, 
commenters believe that the use of unique BIN/PCN/Group numbers will 
give pharmacies the capability to properly coordinate benefits in cases 
when beneficiaries have third party coverage.
    Several commenters indicated that collaboration among CMS, HRSA and 
state Medicaid Agencies will be necessary to ensure that guidance for 
plans and 340B covered entities clearly address the many potential 
challenges of operationalizing the prohibition on duplicate discounts. 
They also recommended that CMS clarify that states may require managed 
care plans to report drug claims that are subject to 340B discounts, 
outside of the utilization reports submitted under paragraph (s)(2) of 
the proposed rule.
    Several commenters expressed support for CMS' proposal requiring 
managed care plans to establish procedures to exclude 340B drugs from 
the drug utilization reports provided to the states. Commenters 
indicated that this clarification is important because of confusion 
among 340B stakeholders regarding how the 340B program operates in 
Medicaid managed care relative to Medicaid FFS. One commenter asked 
that CMS ensure that managed care plans not only take responsibility 
for identifying 340B drugs but also absorb the costs associated with 
that process. The commenter encouraged CMS to ensure that the 
methodologies managed care plans use are not overly administratively 
burdensome for providers (particularly when contracting with multiple 
plans) and that participation in, or the benefit of, the 340B program 
is not limited in the managed care environment. One commenter 
recommended that because of the complexity of 340B claims 
identification and payment--including a lack of using industry claim 
transactions to amend claims transactions--separate guidance be 
provided to help resolve the technically complex nature of 340B claim 
identification issues.
    And finally, several commenters appreciated that CMS explicitly 
stated that 340B providers are not legally responsible for protecting 
manufacturers from having to pay both a 340B discount and a Medicaid 
rebate on a managed care claim. The commenters believed that this 
interpretation is consistent with the statute, and is logical from an 
operational standpoint. Commenters requested that CMS address it 
explicitly in the regulation.
    Response: We appreciate the concerns raised by the commenters and 
recognize the importance of preventing duplicate discounts on drugs 
purchased through the 340B program and dispensed to Medicaid managed 
care plan enrollees. The commenters identified a number of mechanisms 
currently in use by the states to ensure duplicate discounts are not 
paid by manufacturers on 340B drugs.
    When states contract with managed care plans, the contracts should 
include specific language addressing which tools managed care plans can 
use to exclude 340B purchased drugs from utilization, the 
responsibility the MCO has with resolving manufacturer disputes or 
rebate invoices derived from MCOs, state's ability to access data and 
records related to the MCO's exclusion of 340B purchased drugs from 
utilization reports, and any liability the MCO may face in cases of 
unresolved manufacturer disputes of rebate invoices derived from the 
MCO's utilization. For managed care plans, in accordance with section 
1903(m)(2)(A)(xiii)(III) of the Act, MCOs should not report information 
about covered outpatient drugs to the states that are not subject to 
this rebate standard if such drugs are both subject to discounts under 
section 340B of the PHS Act and dispensed by MCOs in accordance with 
section 1927(j)(1) of the Act. We extend those reporting standards to 
PIHPs and PAHPs in this rule using our authority under section 
1902(a)(4) of the Act. Managed care plans can use several methods to 
ensure they report consistent with section 1903(m)(2)(A)(xiii)(III) of 
the Act. For example, plans could include in their contracts with their 
pharmacy providers a reference to billing instructions or processes 
that must be followed when identifying a 340 patient and dispensing a 
340B drug to a Medicaid patient. States may place certain requirements 
on plans to require that covered entities or contract pharmacies use 
specific identifiers on prescriptions so that a managed care plan 
recognizes that the claim should be billed as 340B. Managed care plans 
may issue billing instructions and can assign unique BIN/PCN/Group 
numbers for a particular Medicaid line of business and require 
pharmacies of managed care plan network providers to bill for the 340B 
drug to that specific BIN/PCN/Group. We believe that all parties 
(states, managed care plans, covered entities and pharmacies) should 
ensure that Medicaid rebates are not paid on 340B drugs and should work 
together to establish a standard process to identify 340B claims that 
is collectively effective.
    Comment: Several commenters stated that HRSA has established a 
Medicaid Exclusion File to assist states in identifying 340B claims; 
however, HRSA has also clarified that the file is to be used for FFS 
Medicaid claim identification. Further, states are now mandating use of 
the Medicaid Exclusion File for managed care claims, even though that 
was not its intended purpose.
    Commenters also suggested which entities should be responsible for 
ensuring that duplicate discounts are not paid on 340B drugs. Several 
commenters indicated that each state, not the covered entity, should be 
legally responsible under federal law for protecting manufacturers from 
having to pay both a 340B discount and a Medicaid rebate on a managed 
care claim. Commenters further indicated that it is the responsibility 
of the state and the managed care plans to have

[[Page 27548]]

internal controls including policies/procedures, monitoring, training, 
and audits to avoid duplicate discounts.
    One commenter believed that the Affordable Care Act exempted 340B 
drugs provided to Medicaid managed care enrollees from the manufacturer 
Medicaid rebate requirement to avoid the possibility of duplicate 
discounts. Given that 340B managed care drugs are not subject to 
rebates, the provisions of the 340B statute imposing liability on 
covered entities for creation of duplicate discounts do not apply when 
the underlying drug is provided through managed care plans. Rather, it 
is the responsibility of the states and managed care plans to avoid 
duplicate discounts in the managed care environment. The commenter 
stated they support CMS' proposal to confirm that it is the managed 
care plan's responsibility to avoid duplicate discounts in managed 
care.
    Finally, commenters requested that CMS and the states clearly 
identify what is considered the responsibility of the managed care plan 
and what is considered the responsibility of the state and believe it 
is important for CMS to understand that it is difficult, if not 
impossible, for managed care plans to identify such drugs unless the 
dispensing pharmacy itself identifies a drug as one for which it has 
obtained a 340B discount. Since all Medicaid managed care plans will be 
required to certify the completeness and accuracy of their reports, 
this will put these plans in the untenable position of having to 
certify to the accuracy of information which is not within the plan's 
knowledge.
    Response: All entities (states, managed care plans, and covered 
entities) play a role in ensuring Medicaid rebates are not paid on 340B 
drugs. In accordance with section 1903(m)(2)(A)(xiii)(III) of the Act, 
MCOs are not responsible for reporting information about covered 
outpatient drugs that are not subject to this rebate standard if such 
drugs are both subject to discounts under section 340B of the PHS Act 
and dispensed by MCOs in accordance with section 1927(j)(1) of the Act. 
We extend that protection to PIHPs and PAHPs using our authority under 
section 1902(a)(4) of the Act in this rule.
    We recognize that HRSA established a Medicaid Exclusion File to 
assist in identifying 340B covered entities to avoid duplicate 
discounts paid by manufacturers for FFS claims. As previously stated 
for MCO claims, states may place certain requirements on plans to 
require that covered entities use specific identifiers on prescriptions 
so a pharmacy knows that it is a 340B claim and subsequently uses 
predetermined transaction standards to bill for the 340B purchased drug 
claim. Managed care plans can assign unique BIN/PCN/Group numbers for a 
particular Medicaid line of business.
    We continue to encourage covered entities, states, and Medicaid 
managed care plans develop strategies to ensure accurate identification 
of 340B claims.
    Comment: Several commenters believed that CMS should permit 340B 
providers to report claims data directly to the state or the states' 
rebate contractor, bypassing the managed care plans, such as is 
currently done in at least one state. For example, some managed care 
plans do not possess the technical capability to handle reporting, and/
or do not have the necessary relationships with entities to develop 
successful reporting mechanisms. While this approach may not be 
appropriate for all states, commenters recommended that CMS grant 
states the flexibility to pursue the option if they deem it most 
appropriate.
    Response: Section 438.3(s)(3) requires that the managed care plans 
have procedures to exclude utilization data for covered outpatient 
drugs that are subject to discounts under the 340B drug pricing 
program. We understand that what may work in one state may not in 
another. Therefore, if a state has a process in place where the covered 
entities are required to submit managed care enrollee drug claims data 
directly to the state (or the state's claims processor) prior to the 
state invoicing the manufacturer, the requirement of the managed care 
plan to establish procedures to exclude the utilization as required by 
Sec.  438.3(s)(3) would not be applicable. Therefore, we are revising 
Sec.  438.3(s)(3) to indicate that MCOs, PIHPs or PAHPs establish 
procedures to exclude utilization data for covered outpatient drugs 
that are subject to discounts under the 340B drug pricing program from 
the reports required under paragraph (s)(2) of this section when states 
do not require submission of Medicaid managed care drug claims data 
from covered entities directly.
    Comment: One commenter stated that they believe some states are 
using their encounter files to help submit rebate utilization. Several 
commenters recommended that CMS withdraw its proposed requirement for 
the managed care plans to remove 340B claims utilization from rebate 
utilization reports, as the commenter believes these requirements could 
be extended to encounter files in some states. The commenters believe 
that this recommendation warrants additional study and stakeholder 
input as to the potential ramifications of such a requirement. Another 
commenter stated that states currently use encounter data to review 
managed care plan expenditures, set capitation rates, as well as 
perform retrospective drug utilization review (DUR) and it already 
attests to having procedures in place to make sure that 340B drugs are 
not subject to rebates.
    Response: We appreciate the comments but believe that a change to 
the proposal is not necessary. The regulation at Sec.  438.3(s)(3) 
requires the managed care contract address reporting of data about drug 
claims for a specific purpose; to facilitate invoicing for rebates 
under section 1927 of the Act. It is imperative that the state work 
with the managed care plans to establish procedures to exclude the 
utilization data for covered outpatient drugs that are subject to 
discounts under the 340B drug pricing program if the state does not 
already have a mechanism in place to exclude the drug utilization data 
associated with 340B drugs dispensed to managed care plan enrollees. 
The encounter files are not addressed in Sec.  438.3(s) and not subject 
to the terms of Sec.  438.3(s)(3).
    Comment: Several commenters encouraged CMS to standardize the 
systems and processes used by managed care plans and states to identify 
340B claims, referencing the HRSA-developed Medicaid exclusion file, 
the NCPDP (National Council for Prescription Drug Programs)-developed 
identifier, state-developed methods and other separate systems for 
identifying 340B utilization in claims generated in the outpatient 
clinic. However, the commenter emphasized that there are burdens to a 
patchwork of systems for manufacturers. Thus, commenters believed the 
entire system would operate more effectively and efficiently if all 
parties used the same source data or, in the alternative, if managed 
care plans were required to use the system established by the relevant 
state.
    Response: We do not believe it is appropriate for us to require 
states to use a particular process for identifying 340B drug claims. 
Rather, we encourage the establishment of state-specific systems and/or 
procedures that are effective at excluding 340B drug claims and 
preventing duplicate discounts. As noted earlier, there are a number of 
mechanisms managed care plans can utilize to assist states with 
identifying 340B drug claims, such as requiring pharmacies to use pre-
determined standards or identifiers to submit claims for 340B-purchased 
drugs at the point of sale or utilization of a unique BIN/PCN/

[[Page 27549]]

Group combination related to the plan's Medicaid line of business.
    Comment: One commenter requested that CMS direct states to provide 
manufacturers with access to Claim Level Detail (``CLD''), including 
detail on utilization data submitted by managed care plans so that 
manufacturers can evaluate rebate requests for 340B duplicate 
discounts. They believe that CLD would give manufacturers an important 
additional tool to investigate for non-compliant 340B utilization.
    Response: We did not propose and do not seek to finalize a 
requirement of the scope that the commenter requests. Additionally, the 
state's process for billing for rebates is beyond the scope of this 
rule.
    Comment: A commenter asks that CMS specifically address situations 
when a managed care plan (or state FFS program) requests a Medicaid 
rebate on units for which a state AIDS Drug Assistance Program (ADAP) 
has requested a 340B rebate. The commenter encourages CMS to require 
managed care plans to implement safeguards around potential ADAP 
duplicate or triplicate rebates.
    Response: We agree that safeguards should be in place to avoid 
duplicative rebates on ADAP drug claims, but we decline to impose 
additional requirements beyond our proposal. Managed care plan 
contracts starting on or after July 1, 2017, must be in compliance with 
the provisions of Sec.  438.3(s) as finalized here.
    Comment: Another commenter requested that CMS require managed care 
plans to review past utilization dating back to 2010 which was 
submitted to states and revise any such requests that contained 340B 
utilization. Current period requests for rebates in past periods of 
time (that is, outside of the standard reporting cycle) should likewise 
be appropriately evaluated for improper 340B utilization.
    Response: We will not require that managed care plans review past 
managed care drug utilization back to 2010 as part of this rule. 
However, to the extent states believe managed care utilization data 
have not been reported correctly during those time periods, states 
should work with their managed care plans to correct the data and 
establish processes with the managed care plan to ensure managed care 
plan utilization data is properly reported under this final rule.
    Comment: One commenter recommends that formulary 340B pricing rules 
need to be reassessed given the increased presence of managed care. The 
commenter explained that managed care plans may be able to negotiate 
better pricing than that afforded through historical methods. They 
further suggested an agency study of these pricing mechanisms in a 
managed care environment and adoption of regulatory changes, as 
appropriate, based on the recommendations.
    Response: We thank the commenter for the comment; however, the 
suggestion is beyond the scope of this rule. We will consider 
addressing this issue in future guidance or rulemaking, if needed.
Drug Utilization Review (DUR) Program Requirements (Sec.  438.3(s)(4))
    In paragraph (s)(4), we proposed that MCOs, PIHPs, or PAHPs that 
provide coverage of covered outpatient drugs also operate a DUR program 
that is consistent with the standards in section 1927(g) of the Act; 
this standard means that the DUR program operated by the MCO, PIHP, or 
PAHP would be compliant with section 1927(g) of the Act if it were 
operated by the state in fulfilling its obligations under section 1927 
of the Act. We clarified that this would not mean that the DUR program 
operated by the MCO, PIHP, or PAHP must be the same as that operated by 
the state, but that the MCO's, PIHP's, or PAHP's DUR program meets the 
requirements in section 1927(g) of the Act. This proposal was based on 
our authority under section 1902(a)(4) of the Act. We recognized that 
MCOs, PIHPs, and PAHPs that are contractually responsible for covered 
outpatient drugs generally conduct utilization review activities as 
these activities promote the delivery of quality care in a cost 
effective and programmatically responsible manner. We stated that 
because the MCO, PIHP, or PAHP is providing coverage for covered 
outpatient drugs as part of the state plan instead of the state 
providing that coverage through FFS, it was appropriate to extend the 
DUR responsibilities associated with such coverage to the MCO, PIHP, or 
PAHP. Section 1927(g)(1)(A) of the Act provides, in part, that states 
must provide a DUR program for covered outpatient drugs to assure that 
prescriptions: (1) Are appropriate; (2) are medically necessary; and 
(3) are not likely to result in adverse medical results. The provisions 
proposed in paragraph (s)(4) would be satisfied if the managed care 
plan's DUR program met those standards.
    We received the following comments on proposed Sec.  438.3(s)(4).
    Comment: Several commenters indicated support for the application 
of Medicaid FFS DUR activities to the Medicaid managed care 
prescription drug benefit. One commenter stated that consideration 
should be given to the reporting requirements for managed care DUR 
programs, indicating that while requiring managed care plans to be 
transparent by posting their DUR activities highlighting the 
effectiveness of their DUR programs, this full disclosure of strategies 
may create unfair competitive disadvantages (or advantages) between 
managed care entities.
    Response: We appreciate the comments in support of extending DUR 
operational and reporting requirements to the managed care prescription 
drug benefit. We will provide direction to states as to how managed 
care plans should report DUR activities, which will assist states with 
their annual DUR reporting requirements to CMS.
    Comment: A few commenters stated that DUR was an effective tool for 
quality care and program integrity, but stated the current DUR 
operations and standards under section 1927(g) of the Act are outdated 
or failed to provide enrollees with adequate protections. The commenter 
urged CMS to improve DUR requirements applied to Medicaid managed care.
    Response: We do not agree with the commenters' statements that 
current DUR standards and operations are outdated and fail to provide 
adequate protections. Section 1927(g) of the Act provides a framework 
within which the states are to operate their DUR programs. In 
accordance with the DUR requirements, states have flexibility to adopt 
new standards, such as permitting a portal for physicians to access a 
patient's prescription history before prescribing a new medication 
during electronic prescribing or implementing electronic prior 
authorization processes. Since the statute was enacted, states have 
worked to improve the scope and quality of the operation of their DUR 
programs, and their programs' oversight. In addition, we have improved 
the process by which states annually report on the operation of their 
DUR programs by: (1) Improving the questions in the Medicaid Drug 
Utilization Review Annual Report (https://www.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/downloads/dursurvey_20140617.pdf); (2) providing an electronic 
mechanism that the states use to enter their annual reports; (3) 
posting each state's Medicaid DUR Annual Report on the Medicaid.gov Web 
site; and (4) preparing and posting a comparison/summary report, which 
compiles all the states' responses on their programs' activities 
reported in the

[[Page 27550]]

Medicaid DUR Annual Report. In regard to DUR requirements for Medicaid 
managed care, CMS will provide direction to states as mentioned earlier 
in this document.
    Comment: A few commenters recommended that DUR activities should 
incorporate quality and monitoring activities such as under-utilization 
of prescription drugs which might indicate low pharmacy inventories, 
access issues, or burdensome prior authorization practices.
    Response: We appreciate these suggestions made by the commenters. 
In accordance with section 1927(g)(1)(A) of the Act, states are 
responsible for establishing a program for identifying underutilization 
of prescription drugs. In the state Medicaid DUR Annual Reports 
submitted to CMS, some states have included information on addressing 
under-utilization of prescription drugs by implementing medication 
adherence initiatives. In addition, CMS requests for states to report 
on their monitoring activities to ensure appropriate prescribing of 
several classes of prescription drugs, such as antipsychotics, 
stimulants, opioids and buprenorphine products. The Medicaid DUR Annual 
Report is unable to capture every DUR activity that states perform, but 
addresses prevalent DUR activities and helps to create standardization 
among these programs.
    Comment: One commenter noted that while CMS proposes that managed 
care plans provide DUR programs that are consistent with the federal 
standards that Medicaid agencies must meet (for example, prescribed 
drugs are appropriate, medically necessary and not likely to result in 
adverse medical results), the managed care plan may prefer to screen 
for drug therapy problems of therapeutic duplication, age/gender 
contraindications, adherence, drug-drug interactions, correctness of 
dosage or duration of therapy, and drug-allergy contraindications.
    Response: We agree that the aforementioned DUR activities are 
essential components of DUR; however, retrospective DUR activities 
listed in section 1927(g) of the Act are equally as important to 
improve recipients' quality of care. We defer to the states and if 
applicable, their MCOs, on specific DUR program requirements, as long 
as the minimum federal requirements at section 1927(g) of the Act are 
met.
    Comment: One commenter expressed concern that since requirements of 
section 1927(g) of the Act were enacted, many states and Medicaid 
managed care plans have changed the way in which their DURs operate, 
merging DUR Board activities with the activities of the Pharmacy and 
Therapeutics (P & T) Committees, and effectively changing Preferred 
Drug List or formulary development. The commenter also expressed 
concern that the cost considerations were being given priority over 
clinical effectiveness and safety. The commenter requested that CMS 
affirm that the purpose of DUR is not that of formulary development or 
cost comparison but primarily for clinical reasons.
    Response: We recognize that over time, changes have taken place in 
the manner in which Medicaid state agencies operate their prescription 
drug coverage for the day to day operation of their programs. However, 
we do not agree with the commenter that the ultimate purpose of the 
state Medicaid DUR program has changed its mission or focus. In 
accordance with section 1927(g)(1)(A) of the Act, a DUR program is to 
assure that a state's coverage of covered outpatient drugs are 
appropriate, medically necessary, and are not likely to result in 
adverse medical results. In addition, the Act states that the DUR 
programs should be designed to educate physicians and pharmacists to 
identify and reduce the frequency of patterns of fraud, abuse, gross 
overuse, or inappropriate or medically unnecessary care, among 
physicians, pharmacists, and patients, or associated with specific 
drugs or groups of drugs, as well as potential and actual severe 
adverse reactions to drugs.
    Comment: One commenter expressed concern that DUR programs will 
create barriers to treatment by undermining the clinical judgment of 
treating physicians, especially since mandatory utilization controls 
may vary from plan to plan. The commenter stated that it is important 
that managed care plans be transparent regarding their DUR activities.
    Response: We do not agree with the commenter that DUR programs will 
create barriers. The requirements of DUR programs shall be designed to 
educate physicians and pharmacists to identify and reduce the frequency 
of patterns of fraud, abuse, gross overuse, or inappropriate or 
medically unnecessary care. Section 438.3(s)(5) requires managed care 
plans to provide a detailed description of its DUR program activities 
to the state on an annual basis, which we believe will enhance the 
transparency of managed care plan DUR practices when providing 
outpatient drug coverage to their Medicaid enrollees.
    Comment: One commenter requested that CMS require that managed care 
plans coordinate with the State's DUR Board at least on a quarterly 
basis.
    Response: We appreciate the comment. We will allow each state to 
determine the terms for the managed care plan's DUR operational 
requirements and specify them in the managed care plan contract.
    Comment: One commenter requested that CMS provide further 
clarification and guidance on how states should conduct DUR with their 
managed care plans and their FFS population to minimize duplication and 
reduce administrative burden and expense. Alternatively, the commenter 
requested that CMS clarify why DUR is necessary from both parties, 
rather than have sole state oversight of managed care plan activities.
    Response: We appreciate the commenter's request for clarification. 
We are requiring that states be responsible for ensuring that managed 
care plans operate a DUR program that is consistent with the standards 
in section 1927(g) of the Act when a managed care plan is required by 
the state to provide outpatient prescription drug coverage to the 
Medicaid population enrolled in the plan. We encourage states and 
managed care plans to share ``lessons learned'' and explore options 
that will work best depending on the number and size of the managed 
care plans in the state. Some states require all managed care plans to 
adhere to the preferred drug lists (PDL) and DUR oversight that they 
conduct on their fee-for-service (FFS) population. Other states may 
allow their managed care plans to develop their own DUR programs and 
submit a report on their annual activities. CMS is not requiring that 
the states or plans follow one specific model as long as the DUR 
activities performed by the states and plans meet the minimum 
requirements of section 1927(g) of the Act.
DUR Program Annual Report to the State (Sec.  438.3(s)(5))
    In paragraph (s)(5), we proposed that the MCO, PIHP, or PAHP would 
have to provide a detailed description of its DUR program activities to 
the state on an annual basis. The purpose of the report was to ensure 
that the parameters of section 1927(g) of the Act are being met by the 
MCO's, PIHP's, or PAHP's DUR program, as proposed under paragraph 
(s)(4).
    We received the following comments on proposed Sec.  438.3(s)(5).
    Comment: Several commenters expressed support for managed care 
plan's DUR Boards posting their annual

[[Page 27551]]

reports and coordination with the state DUR Board when reporting data 
and findings to CMS. One commenter suggested that the managed care 
plan's DUR data be included in the state's annual DUR report to CMS as 
well as be included in the Medicaid Drug Utilization Review Comparison/
Summary Report that CMS produces.
    Response: We appreciate the comments and will take the suggestion 
under advisement. Since all states may not have the same managed care 
plan DUR reporting requirements, we will work with states to develop a 
mechanism that will enable all states to report in a way as to ensure 
that the data submitted is compared in an appropriate manner in the 
various reports CMS produces.
    Comment: One commenter suggested that the following language be 
added to Sec.  438.3(s)(5) after the existing text: The MCO, PIHP, 
PAHP, or PCCM entity (if applicable) shall post to its Web site the 
annual report, and provide the report to the state DURB, MCAC, and the 
consumer stakeholder committees established under Sec. Sec.  438.10 and 
438.70.
    Response: We will defer to the state as to how it will publicize 
the annual report and who the report should be disseminated to 
regarding managed care plan DUR activities.
    Comment: One commenter expressed concern that managed care plans 
might object to changing their annual report of their DUR activities, 
stating that while a managed care plan's DUR may not be identical to 
that of the state's FFS DUR, it could be just as effective as, or more 
effective, than the state's process. The commenter urged CMS to allow 
flexibility for the managed care plan's internal operations. Other 
commenters recommended that a managed care plan should be able to 
choose to implement safety interventions either through a DUR program 
or prior authorization, and that plans have the discretion to determine 
which type of intervention will better support their safety goals.
    Response: The proposed rule required that states ensure through 
their contracts with managed care plans that the plans operate a DUR 
program that complies with the requirements of section 1927(g) of the 
Act. Therefore, a managed care plan will only be required to change DUR 
activities to the extent their program does not meet the requirements 
of section 1927(g) of the Act. Prior authorization requirements are an 
important safety mechanism, but do not fulfil the full requirements of 
DUR.
    Comment: One commenter indicated that the requirement for managed 
care plans to report to the state ``in detail on an annual basis'' the 
managed care plans' DUR programs places a burden on the state to have 
additional staff to review such reports. Another commenter requested 
clarification from CMS on whether states are required to include 
managed care plan DUR in the state's annual DUR report as required by 
section 1927(g)(3)(D) of the Act.
    Response: At the present time, there is no requirement that the 
state report to CMS on the specifics of the DUR activities of its 
managed care plans. Since each state will be preparing their own 
managed care plan DUR requirements, we will consider issuing future 
guidance as to how the states include oversight of their managed care 
plans DUR in the states' annual report. The annual DUR survey, that 
states complete to fulfill the requirement of reporting to CMS, 
includes questions on the type of oversight they perform on their 
managed care plans.
Prior Authorization Process (Sec.  438.3(s)(6))
    Finally, in paragraph (s)(6), we proposed that the state stipulate 
that the MCO, PIHP, or PAHP conduct the prior authorization process for 
covered outpatient drugs in accordance with section 1927(d)(5) of the 
Act; we relied again on our authority under section 1902(a)(4) of the 
Act for this proposal. Since the MCO, PIHP, or PAHP is providing 
coverage for covered outpatient drugs as part of the state plan instead 
of the state providing that coverage through FFS, it is appropriate to 
extend the prior authorization standards associated with such coverage 
to the MCO, PIHP, or PAHP. Therefore, we proposed that the MCO, PIHP, 
or PAHP would provide a response to a request for prior authorization 
for a covered outpatient drug by telephone or other telecommunication 
device within 24 hours of the request and dispense a 72 hour supply of 
a covered outpatient drug in an emergency situation.
    We received the following comments on proposed Sec.  438.3(s)(6).
    Comment: Several commenters supported CMS' clarification that 
consumers who need access to a drug not covered by their managed care 
plan will have access to the drug via FFS Medicaid. Specifically, 
commenters recommended that the drug be available when determined to be 
medically necessary, or necessary for beneficiaries whose medical 
situation makes it inadvisable for them to take a formulary drug. A 
commenter requested clarification that rare disease patients with a 
medical need for an orphan drug and enrolled in a managed care plan 
must receive coverage of the drug under the managed care plan's prior 
authorization process; or, if the managed care plan is not 
contractually obligated to provide coverage of a particular drug under 
its contract, the state is required to provide the drug through FFS 
Medicaid (the State plan).
    Response: The managed care plan must meet the prior authorization 
requirements specified at section 1927(d)(5) of the Act and implemented 
through regulation at Sec.  438.3(s)(6) when providing covered 
outpatient drugs to its Medicaid enrolled population. If the managed 
care plan is not contractually required to cover a specific drug or 
group of drugs as part of its formulary, the state will be required to 
cover the drug for the managed care plan enrollee to the same extent it 
covers the drug for the Medicaid FFS population. If a managed care plan 
is required by its contract with the state to cover the orphan drug for 
Medicaid (that is, it is not ``carved out''), the managed care plan 
must provide coverage for the drug as part of its formulary or use a 
prior authorization process for the patient to access the drug when 
medically necessary if not on the managed care plan's formulary.
    Comment: A couple of commenters requested clarification around 
timelines for coverage of newly approved medications. One commenter 
indicated that if managed care plans are expected to comply with the 
standards in section 1927 of the Act, then CMS should indicate that 
managed care plans be given the same right to evaluate newly approved 
drugs as part of their drug utilization review process.
    Response: Consistent with the state's FFS coverage policy for newly 
approved medications, once a drug becomes approved as a covered 
outpatient drug, it becomes eligible for manufacturer rebates, and 
therefore, must be covered by managed care plans providing drug 
coverage to their Medicaid enrollees. Managed care plans still have the 
ability to maintain their own formularies as long as they make these 
newly approved drugs available using prior authorization in accordance 
with section 1927(d)(5) of the Act.
    Comment: A commenter requested that CMS provide guidance on 
establishing a prior authorization process that complies with the 
requirements of the Medicaid rebate statute. Another commenter 
requested that CMS add a new subsection to the regulation to require 
robust exceptions to allow plan enrollees to obtain non-formulary or 
off-label prescription drugs when clinically appropriate. A commenter 
also requested that CMS clarify patients' rights to obtain all

[[Page 27552]]

medically necessary medications by adding clear protections for non-
formulary medications to the regulatory text at Sec.  438.3(s)(6). 
Another commenter urged CMS and states to ensure that any standards for 
prior authorization or exceptions processes remain the responsibility 
of the Medicaid managed care plan.
    Response: It is not our intent in this final rule to dictate to 
states and managed care plans how they will establish their formularies 
or prior authorization processes. As long as the requirements of 
section 1927 of the Act are met, states and managed care plans may 
adopt different formularies and apply different utilization management 
practices (for example, apply different prior authorization 
requirements to different drugs based upon the managed care plan's 
preferred drug list or formulary). As provided in prior responses to 
comments, if the managed care plan's formulary does not provide 
coverage of a drug that is otherwise covered by the state plan for 
individuals in FFS, the managed care plan must ensure access to the 
off-formulary covered outpatient drug consistent with the prior 
authorization requirements at section 1927(d)(5) of the Act.
    Comment: A few commenters requested guidance on coverage of drugs 
for states that carve coverage out of the managed care contract. One 
commenter indicated that for some disease states, including mental 
health, there are legislative carve-outs which preclude traditional 
Medicaid programs or Medicaid managed care plans from placing coverage 
restrictions on drug products. The commenter requests that CMS clarify 
the contract requirements to ensure state carve-outs and mandates are 
maintained to preserve patient access.
    Response: We understand that some states may specifically exclude 
or ``carve-out'' from their Medicaid managed care plan contracts, 
coverage of certain covered outpatient drugs that treat specific 
disease states or chronic conditions, such as drugs specific for 
treatment of HIV. In those instances, states will continue to cover 
these drugs under their state plan and provide that coverage to the 
managed care plan enrollees consistent with the requirements of section 
1927 of the Act for covered outpatient drugs.
    Comment: One commenter suggested that all managed care plans should 
function under a standard or state-wide formulary to ensure patient 
access to needed prescription medications thus preventing a need for 
more costly care. Another commenter indicated they did not support a 
statewide formulary because plans have system-wide formularies and 
creating a different formulary for the Medicaid line of business would 
not support CMS' intent to streamline services across health systems 
and payers. Commenters noted that requiring a managed care plan to 
cover drugs that are not included on the formulary may affect a plan's 
ability to negotiate the best possible rebates. Another commenter 
indicated that it is counter to requirements in other government 
supported health programs that managed care plans be required to use a 
statewide formulary.
    Response: We are not mandating as part of this final rule that 
states include in their contracts with their managed care plans that 
managed care plans use specific or state-required formularies. While we 
understand commenters' concerns that the use of a state-required 
formulary may not be optimal for managed care plans because it may 
hinder the managed care plan's ability to negotiate additional 
discounts or rebates on drugs, we believe that very few states, if any, 
maintain formularies of their own due to the requirements in section 
1927(d)(4) of the Act. However, while there may be challenges to 
managed care plans being required to utilize a state-required 
formulary, there is nothing in statute that precludes a state from 
requiring such a formulary.
    Comment: Commenters indicated that it is important that managed 
care plan formularies satisfy all applicable formulary rules in section 
1927 of the Act, giving enrollee rights to obtain off-formulary or non-
preferred medications in ways that are simple for both the enrollee and 
their prescribing physician. Other commenters recommended that CMS 
establish standards for managed care formularies and exceptions 
processes as it has done for Medicare Part D, QHPs offered on the 
Marketplace, and the broader private health insurance market through 
the essential health benefit rules and use clinical criteria, with 
appropriate clinical experts with improved patient health as the 
primary goal. The commenter recommended that the managed care plan's 
clinical coverage should be reviewed and updated regularly with 
evidence based protocols. Another commenter indicated that a benchmark 
or a floor that ensures that the managed care plan's formulary is not 
more restrictive than the FFS prescription drug coverage is necessary. 
Commenters urged CMS to establish minimum formulary requirements to 
ensure access to care and treatment for certain enrollees, such as 
Hepatitis C virus (HCV) patients, and preclude the need for an 
individual to access the prior authorization processes.
    Response: A state and its managed care plans may continue to have 
different formularies and prior authorization programs. This final rule 
clarifies that when a state is contracting with managed care plans to 
provide covered outpatient drug coverage, the state must ensure that 
the standards of coverage imposed by section 1927 of the Act are met 
when states enroll their beneficiaries into managed care plans. This 
ensures medically necessary drugs are available to plan enrollees to 
the same extent as beneficiaries receiving Medicaid prescription drug 
benefits under the state plan while also allowing the managed care 
plans to adopt their own formularies and drug utilization management 
tools that are consistent with the requirements of section 1927 of the 
Act.
    Comment: We received several comments requesting clarification 
regarding what CMS meant at 80 FR 31115 that managed care plans may 
maintain their own formularies. Commenters stated it is not clear 
whether managed care plan formularies must comply with the formulary 
requirements in section 1927 of the Act, such as prior authorization 
requirements, or whether managed care plans would have flexibility to 
limit their drug coverage in comparison to what is required in the 
Medicaid rebate statute. The commenters requested that CMS clarify if 
managed care plans are permitted to continue to utilize tools and 
techniques to ensure patients receive the most clinically appropriate 
and cost effective medications. Another commenter requested that CMS 
clarify that permitting managed care plans to maintain their own 
formularies does not permit them to offer more limited coverage than 
that outlined in the formulary rules in section 1927 of the Act. 
Commenters requested that CMS clarify if plans and PBMs are allowed to 
negotiate with drug companies to place drugs on formularies and that 
CMS should apply the requirements in section 1927 of the Act to 
recognize the differences between FFS and managed care, permitting 
managed care plans and PBMs to negotiate with states to design 
formularies and deliver pharmacy benefits in a cost effective manner. A 
few commenters requested that CMS clarify when the state is responsible 
for providing access to non-formulary drugs. Commenters believed this 
would ensure that all drugs approved by the FDA are available when 
medically necessary. Commenters further stated that it is important 
that CMS clear up misconceptions created by 2010

[[Page 27553]]

guidance and indicate in regulation text that Medicaid managed care 
plans must comply fully with the rebate requirements, including 
formulary requirements.
    Response: As stated previously, states may allow managed care plans 
to use their own formularies, as well as their own utilization 
management tools to the extent they are consistent with the 
requirements of section 1927 of the Act. Furthermore, nothing in this 
final rule precludes a managed care plan from using PBMs to negotiate 
what is covered on a managed care plan's formulary with manufacturers. 
However, if the managed care plan's formulary or utilization management 
tools do not provide access to a medically necessary covered outpatient 
drug that is otherwise covered by the state plan for individuals in 
FFS, the managed care plan and the state must ensure access to the drug 
consistent with the prior authorization requirements at section 
1927(d)(5) of the Act. However, we do not believe a separate state 
prior authorization process is the most efficient way for managed care 
enrollees to access medically necessary drugs not on the managed care 
plan's formulary.
    Comment: Several commenters requested that CMS ensure enrollee 
access to non-preferred or non-formulary drugs when there is a medical 
need and that prior authorization and utilization management tools (for 
example, step therapy) should be based on expert medical review and not 
used to primarily deny or restrict access for people with chronic and 
complex health conditions or discourage individuals from obtaining 
care. Specifically, some commenters recommended that CMS require plans 
to adopt the same standards for prior authorization as Medicare Part D 
or provide standards for the evaluation of medical need, as well as 
suggested that the final regulation recognize that prior authorization 
is inappropriate for certain patients such as those with HIV, HCV, 
cancer, developmental disabilities, cystic fibrosis, and mental illness 
and should not discriminate against based on patient diagnosis. For a 
vulnerable population like those living with mental illness, commenters 
believed products should have very limited to no prior authorizations 
placed on them to allow providers the full set of medications to 
utilize based on the clinical needs of the patients. Commenters 
indicated that fail-first policies for branded products which are not 
supported by the FDA labeling were not appropriate for these patients. 
Commenters indicated that to meet the standards of section 1927(k)(2) 
of the Act, enrollees must be provided a medically necessary drug 
through a prior authorization process when there is a medical need for 
the covered outpatient drug.
    Response: We agree with the commenters that any prior authorization 
requirements established by the managed care plan or state that result 
in patients being unable to access covered outpatient drugs of 
manufacturers participating in the drug rebate program when such drugs 
are medically necessary is not consistent with the coverage 
requirements of section 1927 of the Act. As stated in section 1927(d) 
of the Act, states may restrict or limit coverage of covered outpatient 
drugs but only to the extent the prescribed use is not for a medically 
accepted indication as defined at section 1927(k)(6) of the Act or 
included in the list of drugs subject to restriction at section 
1927(d)(2) of the Act. In general, individuals enrolled in managed care 
plans or beneficiaries that receive covered outpatient drugs benefits 
under the state plan may not be denied access to covered outpatient 
drugs of manufacturers participating in the drug rebate program when 
such drugs are prescribed for a medically accepted indication. However, 
to determine whether the drug is prescribed for a medically accepted 
indication for the individual, the state or managed care plan may 
subject any covered outpatient drug to prior authorization as long as 
the prior authorization program meets the minimum requirements at 
section 1927(d)(5) of the Act.
    Comment: Several commenters expressed concern with the 24 hour 
prior authorization response time at section 1927(d)(5)(B) of the Act, 
as incorporated at Sec.  438.3(s)(6), and suggested that ``respond'' in 
the statutory language mean that the managed care plan must acknowledge 
the receipt of a clean prior authorization request or request 
additional information when necessary within 24 hours; or, the managed 
care plan must respond to a request within 24 hours after the receipt 
of all information necessary to make a determination. Other commenters 
suggested that the 24 hour time frame be equal to one business day 
since that would prevent the request from falling on a weekend, which 
would make it difficult to obtain necessary information from the 
prescribing provider. One commenter recommended that CMS revise the 24 
hour requirement to allow providers to ask for a reconsideration of a 
prior authorization request and provide additional information, rather 
than requiring the provider to submit a formal appeal. Commenters 
indicated that if a decision must be made and communicated within 24 
hours, they would have significant concerns with this requirement 
because it would require entire systems to change their prior 
authorization practices and could impose administrative costs that make 
achieving a minimum medical loss ratio (MLR) difficult. Other 
commenters recommended a tiered determination system--24 hours of an 
expedited request and within 72 hours for a standard request. 
Commenters questioned the necessity of such an aggressive timeframe and 
it contradicts the timeframes under Sec.  438.210(d) which requires PA 
decision are to be made within 14 calendar days for standard 
authorization decisions and 3 working days for expedited authorization 
decisions.
    Response: Section 1927(d)(5) of the Act requires, in part, that a 
prior authorization program provide a response by telephone or other 
telecommunication device within 24 hours of a request for prior 
authorization and except for the drugs listed in section 1927(d)(2) of 
the Act, provides for the dispensing of at least a 72 hour supply of a 
covered outpatient drug in an emergency situation. The statute does not 
stipulate that the response be within one business day or what the 
response should entail. However, we understand that states and managed 
care plans typically have standard information collection tools such as 
prior authorization forms that must be completed by providers to 
process prior authorizations. We believe that as long as the provider 
has completed the managed care plan's standard information collection 
for prior authorization, the state and managed care plan should have 
all the information necessary for the determination to be made within 
24 hours of the completed request. Any information collection by the 
state or managed care plan beyond what is required by the state's or 
managed care plan's standard information collection for prior 
authorization should not delay the response beyond the 24 hours of the 
completed request. Furthermore, in cases when there is an emergency 
situation and the provider cannot complete the request for prior 
authorization (for example, it is during a weekend or holiday), the 
state or plan must provide for the dispensing of a 72 hour supply of 
covered outpatient drug. We disagree with the commenter that 
implementing these timeframes would hinder the managed care plan's 
ability to meet the MLR requirements in this

[[Page 27554]]

final rule since most plans likely have a prior authorization process 
and the additional administrative expense of complying with section 
1927(d)(5) of the Act should not be significant.
    Comment: We received several comments supporting CMS' proposal to 
require managed care plans to respond to a request for prior 
authorization for a covered outpatient drug within 24 hours of the 
request and dispense a 72 hour supply of a covered outpatient drug in 
an emergency situation. Commenters indicated that a response to prior 
authorization for covered outpatient drugs within 24 hours of a 
request, and a 72 hour supply in an emergency situation, will mitigate, 
but not eliminate some of the most excessive procedural offenses 
against rare disease patients whose access to clinically important 
therapies has been delayed. The commenter believed that without clear 
regulatory protections and enforcement of these rules, it is not clear 
that patients will fully benefit from section 1927 of the Act 
protections.
    Response: We appreciate the support for the proposed requirement 
that managed care plans meet the 24 hour response time and 72 hour 
supply of covered outpatient drugs in emergency situations when 
processing prior authorization requests. We are not aware of any 
excessive procedural offenses, which we assume the commenter means 
states or managed care plans have made it extremely difficult or 
impossible for their Medicaid patients to gain access to medically 
necessary therapies, and believe the protections in statute and part of 
this final rule will not permit restricted access for managed care plan 
enrollees to covered outpatient drugs when drugs are medically 
necessary.
    Comment: Commenters urged CMS to mirror the prior authorization 
standards in Medicare Part D or MA which require a standard review be 
completed within 72 hours and an urgent request to be completed within 
24 hours, not including notification. One commenter stated that 
conducting a prior authorization within 24 hours will essentially be 
treated as expedited which is inappropriate and impacts overall 
administration costs and resources. Another commenter believed that if 
the intent of CMS is for proper alignment of all health programs, 
Medicaid should adopt a standard prescription drug prior authorization 
form much like the suggested form in MA available on CMS' Web site.
    Response: Section 1927(d)(5) of the Act sets forth the requirements 
for prior authorization of covered outpatient drugs under a Medicaid 
state plan. Therefore, adoption of a specific prior authorization form, 
similar to that used by MA organizations and Part D sponsors, under 
this final rule is not necessary given the requirements in section 
1927(d)(5) of the Act. Medicaid does not mandate the use of a standard 
prescription drug prior authorization form or methodology, as each 
managed care plan has the flexibility to establish their own prior 
authorization procedures.
    Comment: One commenter seeks clarification as to whom the managed 
care plan should send the response to the prior authorization request.
    Response: There is no federal requirement as to where the managed 
care plan should send the response regarding a prior authorization 
request. Prior authorization processes will vary, but typically the 
pharmacy or provider dispensing the drug will trigger the request for 
prior approval of a covered outpatient drug before dispensing by 
requesting that the prescribing provider complete a prior authorization 
information form and submit it to the state or managed care plan. Once 
the plan (or state) receives the completed prior authorization request, 
they will have 24 hours to respond to the pharmacy or provider 
regarding the coverage of the drug.
    Comment: One commenter requested clarification on CMS' intent in 
proposing the requirement to provide a 72 hour supply of any covered 
outpatient drug for emergency medications. Another commenter 
recommended that CMS allow managed care plans the discretion to 
determine what constitutes an emergency warranting the dispensing of a 
72 hour supply of a covered outpatient drug. The commenter believed a 
mandatory 72 hour supply requirement prevents managed care plans from 
using proven tools, such as prior authorization or step therapy, to 
manage prescription drugs for both clinical appropriateness and cost. 
Other commenters supported the dispensing a 72 hour supply of a covered 
outpatient drug in an emergency situation as it will benefit 
individuals with urgent medical needs (for example, people with 
bleeding disorders).
    Response: Section 1927(d)(5) of the Act requires, in part, the 
dispensing of at least a 72 hour supply of a covered outpatient drug in 
an emergency situation. We have not defined what constitutes an 
emergency situation in this regard, and have generally relied upon what 
the state considers an emergency situation. Section 1903(m)(1)(A)(i) of 
the Act provides that an MCO make services it provides to individuals 
eligible for benefits under this title accessible to such individuals, 
within the area served by the organization, to the same extent such 
services are made accessible to individuals eligible for medical 
assistance under the state plan (those Medicaid patients not enrolled 
with in the managed care plan). As such, the managed care plan's prior 
authorization process should permit the dispensing of a 72 hour 
emergency supply that, at a minimum, is consistent with how the state 
determines that a 72 hour emergency supply is needed. We do not agree 
that the 72 hour emergency supply requirement, which is meant to 
address emergency situations only, will prevent managed care plans from 
using utilization management tools to manage their covered outpatient 
drug coverage in non-emergency situations.
    Comment: A commenter was concerned that the proposed rule for 
coverage of drugs that are medically necessary and are reimbursed under 
the prior authorization process would provide a disincentive to cover 
anything other than drugs subject to a signed rebate agreement and are 
``required'' under the statute. All other drugs would be left to be 
reimbursed under the state FFS requirements, providing a ``back-up'' 
situation. The commenter suggested that this would discourage managed 
care plans from covering drugs that could otherwise be excludable under 
section 1927(d)(2) of the Act, such as drugs for weight loss.
    Response: Nothing in this final rule prevents states or managed 
care plans from either restricting coverage or covering in full the 
drugs listed at section 1927(d)(2) of the Act, including agents when 
used for weight loss (see section 1927(d)(2)(A) of the Act). However, 
if a state elects to provide coverage of one of the agents listed at 
section 1927(d) of the Act and include such drugs under the managed 
care contract, the managed care plans must provide coverage consistent 
with the state's approved state plan for such drugs.
    Comment: Several commenters recommended that CMS apply protections 
for the six protected classes of drugs under the Medicare Part D 
program to Medicaid managed care, including the prohibition of onerous 
prior authorization requirements. Commenters believe that the Part D 
protections are designed to mitigate the risks and complications 
associated with an interruption of therapy for certain vulnerable 
populations and should also apply to Medicaid managed care plans. 
Specifically, commenters recommended that enrollees that are currently 
taking

[[Page 27555]]

immune suppressants (for prophylaxis of organ transplant rejection), 
antidepressants, antipsychotics, anticonvulsants, antiretrovirals, or 
antineoplastic classes of drugs should not be subject to either prior 
authorization or step therapy requirements.
    Response: We do not believe it is necessary to require the Part D 
protections for the six protected classes of drugs on Medicaid managed 
care plans because the state, and the managed care plan when 
applicable, must ensure access to covered outpatient drugs consistent 
with the formulary and prior authorization requirements at section 1927 
of the Act. Unlike Part D formulary requirements, the formulary 
requirements at section 1927(d)(4)(C) of the Act include a provision 
for treatment of specific diseases or conditions for an identified 
population. This section of the statute specifies that a drug can only 
be excluded from a formulary because, based on the drug's labeling, it 
does not have a significant, clinically meaningful therapeutic 
advantage in terms of safety, effectiveness, or clinical outcome of 
such treatment for such population over other drugs included in the 
formulary and that there is a written explanation of the basis for the 
exclusion. We believe this formulary requirement ensures that 
vulnerable Medicaid populations that take drugs within the six 
protected drug classes will have access to these drugs including those 
vulnerable individuals enrolled in managed care plans. We note that if 
a covered outpatient drug is subject to prior authorization 
requirements, section 1927(d)(5) of the Act requires states to provide 
a response within 24 hours of the prior authorization request and 
dispensing of at least a 72 hour supply of a covered outpatient drug in 
emergency situations. Furthermore, section 1927(d)(4)(D) of the Act 
permits coverage of a drug excluded from the formulary, but does not 
allow for selected drugs (such as agents used to promote smoking 
cessation, barbiturates, or benzodiazepines) or classes of such drugs, 
or their medical uses, to be excluded from coverage, as stated in 
section 1927(d)(7) of the Act.
    After consideration of the public comments, we will finalize Sec.  
438.3(s) as proposed except for the following modifications:
     Revision to the introduction language of section 438.3(s) 
to make a minor correction to address a grammatical issue; and
     In response to comments about states that may currently 
have processes in place to receive drug claims data directly from 
covered entities so that states can exclude the 340B utilization data 
from their state files before invoicing manufacturers for rebates, we 
have revised Sec.  438.3(s)(3) to indicate that MCOs, PIHPs, or PAHPs 
must have procedures to exclude utilization data for covered outpatient 
drugs that are subject to discounts under the 340B drug pricing program 
from the reports required under paragraph (s)(2) of this section when 
states do not require submission of Medicaid managed care drug claims 
data from covered entities directly.
r. Requirements for MCOs, PIHPs, or PAHPs Responsible for Coordinating 
Benefits for Dually Eligible Individuals (Sec.  438.3(t))
    In Sec.  438.3(t), we proposed a new contract provision for MCO, 
PIHP, or PAHP contracts that cover Medicare-Medicaid dually eligible 
enrollees and delegate the state's responsibility for coordination of 
benefits to the managed care plan. Under our proposal, in states that 
use the automated crossover process for FFS claims, the contract would 
need to provide that the MCO, PIHP, or PAHP sign a Coordination of 
Benefits Agreement and participate in the automated crossover process 
administered by Medicare.
    We received the following comments in response to our proposal to 
add Sec.  438.3(t).
    Comment: Most commenters supported the proposed rule. Several 
commenters suggested providing states with flexibility for alternative 
arrangements. One raised concern about ensuring access to Medicare 
eligibility files. One commenter requested confirmation that managed 
care plans would be exempt from crossover fees, similar to the 
exemption for states. Another requested controls to prevent duplicate 
discounts. One commenter expressed concerns that that delegated claims 
could result in delays in payment.
    Response: We appreciate the comments in support of the rule. We are 
finalizing the rule as proposed, with the following clarifications. 
Delegating coverage of Medicare cost-sharing to managed care plans 
remains optional for states under the rule. For states that do delegate 
cost-sharing coverage, we will provide states and managed care plans 
with technical assistance as needed to enable the managed care plans to 
enter into Coordination of Benefits Agreements (COBA) to receive 
Medicare crossover claims. We understand that managed care plans will 
need some time to enter into COBAs. (Note that managed care plans will 
receive COBA crossover claims from Medicare FFS claims only). We expect 
to accommodate situations where a managed care plan may need additional 
data to set up and process a crossover claim. Currently, CMS provides 
additional data as necessary to managed care plans that have an 
existing COBA. Medicaid managed care plans will be exempt from 
crossover fees to the same extent that states are. CMS will provide 
states and managed care plans with technical assistance to prevent 
inappropriate discounts and delays in payment of claims.
    After consideration of the public comments, we are finalizing Sec.  
438.3(t) as proposed.
s. Payments to MCOs and PIHPs for Enrollees That Are a Patient in an 
Institution for Mental Disease (Sec.  438.3(u) Redesignated at Sec.  
438.6(e))
    In the proposed rule, we discussed our longstanding policy that 
managed care plans generally have had flexibility under risk contracts 
to offer alternative services or services in alternative settings in 
lieu of covered services or settings if such alternative services or 
settings are medically appropriate, cost-effective, and are on an 
optional basis for both the managed care plan and the enrollee. We 
noted, however, that legal issues are presented if the services offered 
in lieu of state plan services are furnished in an Institution for 
Mental Disease (IMD) setting, given the fact that, under subparagraph 
(B) following section 1905(a)(29) of the Act, Medicaid beneficiaries 
between ages 21 and 64 are not eligible for medical assistance (and 
thus FFP) while they are patients in an IMD. Under this broad 
exclusion, no FFP is available for the cost of services provided either 
inside or outside the IMD while the individual is a patient in the 
facility.
    Since the capitation payments are made to the MCO or PIHP for 
assuming the risk of covering Medicaid-covered services during the 
month for which the capitation payment is made, there would be no such 
risk assumed in the case of an enrollee who is a patient in an IMD for 
the entire month, as the enrollee could not, by definition, be entitled 
to any Medicaid covered benefits during that month. Thus, it would not 
be appropriate for an MCO or PIHP to receive FFP for a capitation 
payment for a month for which an enrollee is a patient in an IMD the 
entire month.
    To ensure that the use of IMD settings in lieu of covered settings 
for this care is sufficiently limited so as to not contravene 
subparagraph (B) following section 1905(a)(29) of the Act, we

[[Page 27556]]

proposed to permit FFP for a full monthly capitation payment on behalf 
of an enrollee aged 21 to 64 who is a patient in an IMD for part of 
that month to cases in which: (1) The enrollee elects such services in 
an IMD as an alternative to otherwise covered settings for such 
services; (2) the IMD is a hospital providing psychiatric or substance 
use disorder (SUD) inpatient care or a sub-acute facility providing 
psychiatric or SUD crisis residential services; and (3) the stay in the 
IMD is for no more than 15 days in that month.
    In the proposed rule (80 FR 31116), we discussed that managed care 
programs may achieve efficiency and savings compared to Medicaid FFS 
programs by managing care through numerous means, including networks of 
providers, care coordination and case management. We also acknowledged 
that inherent in transferring the risk for Medicaid coverage during a 
period means that capitation payments may be made for months during 
which no Medicaid services are used by a particular beneficiary who is 
enrolled with the managed care plan, even though the managed care plan 
is at risk for covering such costs if they are incurred. Thus, we 
believed it would be appropriate to permit states to make a monthly 
capitation payment that covers the risk of services that are eligible 
for FFP rendered during that month when the enrollee is not a patient 
in an IMD, even though the enrollee may also be a patient in an IMD 
during a portion of that same period. A corollary of our proposal was 
that capitation payments eligible for FFP may not be made if the 
specified conditions outlined in this section are not met and that, if 
a beneficiary were disenrolled for the month from the MCO or PIHP, a 
state would have to ensure that covered Medicaid services (that is, 
services under the Medicaid state plan that are medically necessary 
during any period when the beneficiary is not a patient of an IMD and 
that are incurred during the month when the beneficiary is not enrolled 
in the MCO or PIHP) are provided on a FFS basis or make other 
arrangements to assure compliance. In addition, a state could refrain 
from seeking FFP for payments made for services provided to 
beneficiaries who are patients in an IMD for a longer period during the 
month as the Medicaid exclusion does not apply where the state pays the 
full amount for services with state-only funds.
    We proposed that services rendered to a patient in an IMD may be 
considered ``in lieu of services'' covered under the state plan. As 
noted in section I.B.2.e, ``in lieu of services'' are alternative 
services or services in a setting that are not covered under the state 
plan but are medically appropriate, cost effective substitutes for 
state plan services included within the contract (for example, a 
service provided in an ambulatory surgical center or sub-acute care 
facilities, rather than an inpatient hospital). However, an MCO, PIHP 
or PAHP may not require an enrollee to use an ``in lieu of'' 
arrangement as a substitute for a state plan covered service or 
setting, but may offer and cover such services or settings as a means 
of ensuring that appropriate care is provided in a cost efficient 
manner. Accordingly, the contract may not explicitly require the MCO or 
PIHP to use IMD facilities, and must make clear that the managed care 
plan may not make the enrollee receive services at an IMD facility 
versus the setting covered under state plan. However, the contract 
could include, in its list of available Medicaid-covered services to be 
provided under the contract, services such as inpatient psychiatric 
hospital services. The MCO or PIHP could then purchase these services 
from an IMD rather than an inpatient hospital if it so chooses to make 
the covered services available.
    We proposed to limit payment of capitation rates for enrollees that 
are provided services while in an IMD (to stays of no more than 15 days 
per month and so long as the IMD is a certain type of facility) for two 
reasons. First, our proposal sought to address the specific concerns 
about ensuring access to and availability of inpatient psychiatric and 
SUD services that are covered by Medicaid; these concerns have focused 
on short-term stays. The expansion of the Medicaid program coupled with 
the overall increase in health care coverage in managed care plans in 
the Marketplace led us to expect greater demand on the limited 
inpatient resources available to provide mental health and SUD 
services. Specifically, we provided a number of statistics in the 
proposed rule, at 80 FR 31117, regarding the anticipated need for 
mental health and SUD services. We noted that states and other 
stakeholders have raised concerns that access to and availability of 
short-term inpatient psychiatric and SUD services have been compromised 
and that delays in the provision of care may occur. Managed care plans 
have an obligation to ensure access to and availability of services 
under Medicaid regulations for services not prohibited by statute and 
covered under the contract. To meet that obligation, managed care plans 
have used alternate settings, including short term crisis residential 
services, to provide appropriate medical services in lieu of Medicaid-
covered settings.
    The second reason we proposed to limit the payment of capitation 
rates for enrollees that are provided services while in an IMD is that 
we believe that subparagraph (B) following section 1905(a)(29) of the 
Act is applicable to the managed care context. Managed care plans 
should not be used to pay--under the Medicaid program--for services for 
which coverage and payment are prohibited by the Medicaid statute. If 
an enrollee were a patient in an IMD for an extended period of time, 
the likelihood that the enrollee would otherwise be incurring 
authorized Medicaid-covered expense or receiving Medicaid-covered 
services--and with it, the risk on the managed care plan of having to 
furnish covered services that is compensated by the capitation 
payment--would not exist during that extended period when the enrollee 
is a patient in the IMD. We noted that permitting capitation payments 
when an enrollee has a short-term stay in an IMD is a means of securing 
compliance with the statute by delineating parameters for these 
capitation payments, which we would otherwise exclude or prohibit to 
achieve compliance with the statutory IMD exclusion.
    Therefore, we proposed that for a month in which an enrollee is an 
IMD patient, FFP in capitation payments will only be provided if the 
enrollee receives inpatient services in an IMD for a period of no more 
than 15 days. This 15-day parameter is supported by evidence of lengths 
of stay in an IMD based on data from the Medicaid Emergency Psychiatric 
Demonstration. This preliminary evidence suggests that the average 
length of stay is 8.2 days.\4\ We proposed to define a short-term stay 
as no more than 15 days within the month covered by the capitation 
payment to account for the variability in the length of stay often 
experienced by individuals who need acute inpatient psychiatric or SUD 
services. We would expect practice patterns for the same services, 
whether delivered in an inpatient hospital or an IMD facility would be 
similar and that such patterns would be monitored by the state. We 
noted that an enrollee could have a length of stay longer than 15 days 
that covers two consecutive months where the length of stay within each 
month is less than 15 days, and, under this rule, the MCO or PIHP would 
be eligible to receive a capitation payment for that enrollee for both 
months. We requested comment on this

[[Page 27557]]

provision, general approach and methodology, or any other comments. We 
also requested comment on the proposed definition of a short-term acute 
stay in this context, including the cost of IMD services in FFS or 
managed care, the wisdom of reflecting a number as either a hard cap on 
the amount of time for which FFP would be available via the capitation 
payment, or as an articulation of the average length of stay across a 
managed care plan's enrollees that would legitimize FFP. We also 
requested comment on ways to operationalize use of an average length of 
stay in terms of capitation payment development and oversight. Finally, 
we requested comment on the percentage of enrollees that have a length 
of stay of less than 15 days for inpatient or sub-acute psychiatric 
services.
---------------------------------------------------------------------------

    \4\ http://innovation.cms.gov/Files/reports/MEPD_RTC.pdf, page 
12.
---------------------------------------------------------------------------

    For purposes of rate setting, we explained the state and its 
actuary may use the utilization of services provided to an enrollee 
while they have a short term stay as a patient in an IMD to determine 
an estimate of the utilization of state plan services, that is, 
inpatient psychiatric services or SUD services, covered for the 
enrolled population in future rate setting periods. However, we 
provided that the costs associated with the services to patients in an 
IMD may not be used when pricing covered inpatient psychiatric 
services; rather, the IMD utilization must be priced consistent with 
the cost of the same services through providers included under the 
state plan. We noted that this guidance for accounting for service 
utilization to patients in an IMD differs from rate setting guidance 
issued in December 2009 for in lieu of services in the context of home 
and community based services, see CMS, Providing Long-Term Services and 
Supports in a Managed Care Delivery System: Enrollment Authorities and 
Rate Setting Techniques (December 2009), at page 15, available at 
http://www.pasrrassist.org/sites/default/files/attachments/10-07-23/ManagedLTSS.pdf.\5\ In the context of services rendered to patients in 
an IMD, we provided that such proxy pricing is not consistent with the 
statutory prohibition on FFP for services when the enrollees is a 
patient in an IMD.
---------------------------------------------------------------------------

    \5\ In that guidance, we provided that the state may modify the 
rate setting process to account for the expected cost as well as 
utilization of in lieu of services as a proxy for the cost of 
approved state plan services in a contract.
---------------------------------------------------------------------------

    We received the following comments on proposed Sec.  438.3(u).
    Comment: Many commenters supported proposed Sec.  438.3(u) to 
permit managed care plans to receive a Medicaid capitation payment for 
enrollees with a short-term stay in an IMD during the month covered by 
that capitation payment. Commenters also supported the proposal to 
permit managed care plans to cover short[hyphen]term inpatient care in 
facilities providing psychiatric or substance use disorder services, 
notwithstanding the IMD exclusion. Commenters stated that the proposed 
rule would support individuals with mental health or substance use 
disorder conditions who need access to inpatient care. Commenters also 
stated that this provision is an important step to address access 
issues for short-term inpatient stays and provides Medicaid managed 
care plans increased flexibility to ensure access to alternative care 
settings. Many commenters recommended that CMS repeal the IMD exclusion 
in entirety.
    Response: We appreciate the commenters' support for this provision. 
As we discussed in the preamble to the proposed rule (80 FR 31116-
31118) and in response to comments herein on this provision, we 
maintain that the recognition of a managed care plan's ability to cover 
short-term inpatient stays of no more than 15 days in an IMD as an 
alternative setting in lieu of settings for inpatient services covered 
under the state plan serves an integral role in ensuring access to 
mental health and substance use disorder services in those states with 
otherwise limited inpatient bed capacity. Further, the prohibition on 
FFP for services rendered to an individual aged 21-64 who is a patient 
in an IMD is statutory, and therefore cannot be eliminated without 
Congressional action.
    Comment: We received several comments on the authority underlying 
this provision. Some commenters contended that CMS lacks statutory 
authority to issue proposed Sec.  438.3(u) because the statutory 
provision prohibiting FFP for services provided to individuals 21-64 in 
IMDs is a broad exclusion and is applicable to the managed care 
context. Commenters stated that while section 1915(b)(3) of the Act 
permits states to offer Medicaid beneficiaries additional services not 
covered under the state plan through savings generated under a managed 
care program, the capitation payments for such additional services 
include FFP and cannot pay for services for individuals 21-64 who are 
patients in an IMD. Additionally, commenters noted that Title XIX 
statutory authorities for states to implement a managed care delivery 
system identify the particular statutory provisions that may be waived 
(that is, statewideness per section 1902(a)(1) of the Act, 
comparability of services per section 1902(a)(10)(B) of the Act; and 
freedom of choice per section 1902(a)(23)(A) of the Act) and the IMD 
provision is not specified under those authorities. Therefore, these 
commenters recommended that CMS not finalize this proposal.
    Other commenters highlighted that CMS has in the past permitted 
managed care plans to provide medically appropriate, 
cost[hyphen]effective substitutes in lieu of state plan services 
included under the managed care plan contract. Commenters stated that 
this in lieu of policy originates from section 1915(a) of the Act which 
specifies that a state shall not be deemed to be out of compliance 
solely by reason of the fact that the State has entered into a contract 
with an organization which has agreed to provide care and services in 
addition to those offered under the State plan to individuals eligible 
for medical assistance. Commenters also stated that CMS has ample 
statutory authority beyond section 1915 of the Act to both permit 
managed care plans to offer coverage for services in addition to what 
is covered in a state plan and to allow for payment by the managed care 
plan for services rendered in an IMD in lieu of state plan services. 
Several commenters were supportive of the discussion of the legal 
authority for Medicaid managed care plans to provide additional 
services not covered under the state plan (80 FR 31116-31117). In 
addition, a commenter explained that the inclusion of mental health 
coverage in the benchmark benefit standard under the Affordable Care 
Act and the parity requirements under EHB/MHPAEA also lend support to 
for this proposed provision.
    Response: We appreciate the comments received in support of and in 
opposition to our described authority for this particular proposal to 
authorize under 42 CFR part 438, under conditions, payment of the 
capitation rate for a month when the enrollee is a patient of an IMD 
for no more than 15 days. We agree that subparagraph (B) following 
section 1905(a)(29) of the Act applies in the managed care context, 
which is why we do not permit FFP in capitation payments for a month in 
which the enrollee is an IMD patient for more than 15 days within the 
month. We believe this provision remains consistent with subparagraph 
(B) following section 1905(a)(29) of the Act for the following reasons. 
By establishing the length of stay in an IMD that is less than the 
period covered by the monthly capitation payment the enrollee has a 
period of time during that month in which he or she is not a

[[Page 27558]]

patient in an IMD (thus could receive Medicaid-covered services for 
which FFP is available), and, because the MCO or PIHP would bear the 
risk of paying for covered services during the period when the enrollee 
is not a patient in an IMD within the month covered by the capitation 
payment, it is appropriate for a capitation payment to be made. The 
final part of the analysis is that the MCO's or PIHP's use of the IMD 
is in accordance with a managed care plan's ability to provide in lieu 
of services. The waivers of comparability of services (section 
1902(a)(10)(B) of the Act) and statewideness (section 1902(a)(1) of the 
Act) accompany all authorities under which a managed care delivery 
system may be authorized. The waiver of comparability of services 
permits the managed care plan to provide services that are different in 
amount, duration, or scope than those under the state plan; thus, 
managed care plans may provide services that are a substitute for, 
although not identical to, state plan services. The waiver of 
statewideness permits the provision of different or substitute services 
to some beneficiaries but not all within the state Medicaid program; 
consistent with this wavier, services provided by the managed care plan 
in lieu of state plan services are not available to beneficiaries not 
enrolled in the managed care delivery system.\6\ As part of a risk 
contract and in accordance with the requirement (at section 
1903(m)(2)(A)(iii) of the Act) that capitation rates be actuarially 
sound and based on services covered under the state plan (as specified 
at Sec.  438.3(c) and Sec.  438.4 of this final rule), we have 
historically provided managed care plans the flexibility to use the 
capitation payment to provide substitute services or settings, 
including when there is no comparable service under the state plan or 
when the additional service or setting is in lieu of services or 
settings that are covered under the state plan. We have required that 
such services be medically appropriate and cost effective alternatives, 
which the enrollee agrees to receive in lieu of state plan services. So 
long as these substitute services or setting are medically appropriate, 
they provide a cost-effective means to secure the goal of the Medicaid 
program to diagnose, treat or ameliorate health or medical conditions.
---------------------------------------------------------------------------

    \6\ We note that the waiver of comparability also supports a 
managed care plan's provision of services in addition to those in 
the state plan through savings.
---------------------------------------------------------------------------

    To clarify, the state may pay for services provided to individuals 
eligible under the state plan that are enrolled in a managed care 
program who are patients in an IMD for a longer term than 15 days 
within the period covered by the capitation payment, either directly or 
through a separate arrangement without FFP. This provision does not 
prohibit the provision of services in an IMD by the state under non-
Medicaid programs beyond the specified short term stay; however, FFP 
would not be available for a capitation payment in any month in which 
the individual is a patient in an IMD for longer than 15 days. 
Moreover, since services for enrollees with longer stays would not be 
covered under the Medicaid program, any capitated payment for such 
individuals with longer stays would not be covered under the Medicaid 
program, any capitated payment for such individuals would need to be 
under a separate contract (since the costs for such individuals would 
have to be accounted for separately in setting the capitation rate and 
the capitation rate would be paid with state-only funds).
    Comment: Several commenters pointed out that the preamble discussed 
the provision of both psychiatric and SUD services. They recommended 
that CMS revise Sec.  483.3(u) to be inclusive of both psychiatric and 
SUD inpatient or sub-acute residential crisis services to be consistent 
with the preamble in the proposed rule.
    Response: We appreciate this request for clarification of the 
regulatory text and will finalize, consistent with the description of 
our proposal, this provision with references to psychiatric and 
substance use disorder treatment provided in both inpatient and sub-
acute facilities. An additional technical correction to the regulatory 
text is necessary for consistency with the proposed rule; specifically, 
the proposal and final rule are limited to enrollees aged 21 to 64. We 
will finalize this provision with a reference to enrollees aged 21 to 
64.
    Comment: Several commenters noted that the proposed rule cites the 
decrease in psychiatric hospital beds across the country as part of the 
rationale for changing the interpretation of the IMD payment exclusion 
to increase access to inpatient treatment. Commenters stated that the 
decrease in psychiatric hospital beds reflects a deliberate public 
policy shift away from the historic overreliance on psychiatric 
institutions and an increased investment in community mental health 
services that reduce the need for psychiatric hospitalization. 
Commenters noted that states have shifted resources away from 
psychiatric hospitals and toward community-based services. Other 
commenters stated that IMDs do not have the expertise, appropriate 
professional staff, or other capacity to provide short-term crisis 
services to people with serious mental illness. Commenters stated that 
most individuals would not benefit from a short-term stay in an IMD; 
rather, most individuals would be better served in the community. 
Commenters recommended that CMS not finalize this proposal so as not to 
incentivize increased admissions to psychiatric hospitals at the 
expense of developing appropriate community-based services.
    Response: While we agree that most beneficiaries would be well 
served in the community, others may need more intensive services such 
as acute inpatient psychiatric care offered by general hospitals and 
inpatient psychiatric hospitals. As part of the continuum of care for 
behavioral health conditions, some short-term psychiatric services 
delivered in inpatient settings, including those delivered in 
facilities that meet the definition of an IMD, may be medically 
necessary depending on the needs of the individual. For example, 
services provided in acute and sub-acute levels of care may be 
appropriate for individuals experiencing a psychiatric episode that 
requires emergency care. We do not intend to incentivize admissions to 
inpatient psychiatric settings for services that are not medically 
necessary and appropriate, nor incentivize lengths of stay in inpatient 
psychiatric settings that are not medically necessary and appropriate. 
We take seriously our commitment to community integration approaches 
and adherence to Olmstead provisions requiring treatment in the least 
restrictive setting available. However, we balance those points with 
the recognition that short-term inpatient stays may be necessary for 
individuals with the most acute behavioral health needs and are 
concerned that access to them may not currently be sufficient. We 
remind states and managed care plans of their obligations under the ADA 
and the Olmstead decision to provide services in the least restrictive 
setting possible and to promote community integration. Nothing in this 
final rules excuses failure to comply with these responsibilities.
    Comment: A few commenters recommended that CMS provide a non-
exclusive list of the characteristics that would enable a facility to 
qualify as a ``sub-acute facility.'' Commenters stated that, at a 
minimum, community mental health centers with inpatient beds should 
qualify as sub-acute facilities. Commenters also recommended that CMS 
provide a non-exclusive list of the characteristics of ``crisis 
residential services.'' Commenters recommended

[[Page 27559]]

that CMS clarify whether the availability of reimbursement is limited 
to crisis residential services. A few commenters also recommended that 
CMS annually publish a list of all IMD facilities within a state.
    Response: We recognize that states may have various definitions of 
sub-acute facilities and crisis residential centers. Further, these 
definitions may not have consistent characteristics across states. We 
are considering releasing sub-regulatory guidance that would provide 
information to states regarding the characteristics of sub-acute and 
crisis services that divert individuals from acute stays in inpatient 
hospitals for psychiatric and substance use disorders. However, we 
decline at this time to publish an annual list of IMD facilities within 
a state, as the value of doing so is not immediately clear.
    Comment: Several commenters recommended that CMS clearly establish 
and define in lieu of services in the final regulation. Commenters also 
recommended that CMS include explicit language in the final rule 
stating that managed care plans can provide covered behavioral health 
benefits in facilities that are considered IMDs as long as the 
requirements for in lieu of services are met, including that the 
enrollee has agreed to the substitution and the service is cost-
effective. Several commenters also recommended that CMS specify that to 
be an in lieu of service and to receive the capitated payment, the 
managed care plan must provide the enrollee meaningful choice between 
the IMD service and a community-based crisis service. Commenters also 
recommended that CMS specify that managed care plans can continue to 
receive payment for covered medical services provided to enrollees 
while they are patients in IMD facilities. One commenter recommended 
that CMS clarify whether states may contractually require managed care 
plans to make in lieu of services available to enrollees.
    Response: We appreciate commenters' recommendations to codify our 
longstanding in lieu of services policy in regulation text as generally 
applied, as well as in the IMD context. We agree that such clarity is 
appropriate and that defining the standards and parameters for ``in 
lieu of services'' will aid states and managed care plans. We will 
finalize Sec.  438.3(e)(2) to address in lieu of services as explained 
more fully below.
    First, we will finalize the substance of proposed Sec.  438.3(u), 
relating to capitation payments for enrollees with a short term stay in 
an IMD, at Sec.  438.6(e) in this final rule. The proposed rule's 
designation of this section under Sec.  438.3 ``Standard Contract 
Provisions'' could suggest that all states must provide access to 
psychiatric or SUD services through IMDs and that was not our intent. 
By moving this provision to Sec.  438.6 ``Special Contract Provisions 
Related to Payment'', it is clearer that it is at the state's option to 
authorize use by managed care plans of IMDs as an in lieu of setting 
and the requirements therein must be followed to make a capitation 
payment for such enrollees. We are finalizing this rule largely as 
proposed, with little substantive change. Provision of the capitation 
payment for enrollees who are short-term patients in an IMD under this 
rule must also comply with the requirements we are finalizing for 
managed care plan coverage of in lieu of services with one difference 
related to rate setting that is addressed below. We clarify here that 
the capitation payment that is made for enrollees that fall under this 
provision represents the full capitation for that enrollee's rate cell 
and in response to these comments have added regulation text addressing 
the in lieu of services policy generally in this final rule.
    Second, we have modified Sec.  438.3(e), which explains additional 
services (not covered under the state plan) that may be covered by an 
MCO, PIHP, or PAHP on a voluntary basis, to include a new paragraph 
(e)(2) that sets forth the criteria for a separate category of 
additional services or settings provided in lieu of state plan services 
as follows: the state determines that the alternative service or 
setting is a medically appropriate and cost effective substitute for 
the covered service or setting under the state plan; the enrollee is 
not be required by the MCO, PIHP, or PAHP to use the alternative 
service or setting; the approved in lieu of services are identified in 
the MCO, PIHP, or PAHP contract, and will be provided at the option of 
the MCO, PIHP, or PAHP; and the utilization and cost of in lieu of 
services would be taken into account in developing the component of the 
capitation rates that represents the covered state plan services. We 
also note that the regulatory standard for rate setting is different 
when using an IMD as an in lieu of setting and that distinction is 
provided in revised Sec.  438.6(e).
    As provided in response to commenters that were concerned that the 
IMD provision would counter efforts for community integration, we 
highlight that the in lieu of service or setting must be medically 
appropriate. While we agree that most beneficiaries would be well 
served in the community, others may need more intensive services such 
as acute inpatient psychiatric care offered by general hospitals and 
inpatient psychiatric hospitals. As part of the continuum of care for 
behavioral health conditions, some short-term psychiatric services 
delivered in inpatient settings, including those delivered in 
facilities that meet the definition of an IMD, may be medically 
necessary depending on the needs of the individual. These requirements 
for in lieu of services at Sec.  438.3(e)(2) must be satisfied in 
addition to the specific standards contained in the IMD provision at 
Sec.  438.6(e). Specifically, the IMD must be a facility that is a 
hospital providing psychiatric or substance use disorder inpatient care 
or a sub-acute facility providing psychiatric or SUD crisis residential 
services and the stay in the IMD is for no more than 15 days during the 
period covered by the monthly capitation payment. Further, the enrollee 
cannot be required to use the alternate setting or service; the 
enrollee must be allowed to opt for provision (and coverage) of the 
service and setting authorized in the state plan. Authorizing ``in lieu 
of'' services and settings under this final rule is not intended to 
limit enrollee choices or to require enrollees to receive inappropriate 
services. We emphasize that this is a basic element for in lieu of 
service to meet the provisions of this rule.
    Third, in Sec.  438.6(e), we add a cross-reference to the 
provisions of Sec.  438.3(e)(2) to ensure compliance with the in lieu 
of services requirements, and add with additional regulation text to 
supersede the rate development component in Sec.  438.3(e)(2)(iv). 
Specifically, we finalize regulation text for how to reflect services 
rendered in an IMD covered under this rule in the capitation rates in 
the manner we proposed (80 FR 31118); the state may use the utilization 
of services provided to an enrollee in an IMD but must price 
utilization at the cost of the same services through providers included 
under the state plan.
    Comment: A few commenters recommended that CMS clarify that, where 
state law requires the state and not the managed care plan to pay for 
care at an IMD, the managed care plan would not receive a capitation 
payment and not be expected to pay for an enrollee's care at such a 
facility.
    Response: Discussions related to the effect of state law are 
outside the scope of this final rule. We restate, however, that making 
use of the flexibility provided under Sec. Sec.  438.6(e) and 
438.3(e)(2) is optional and a state may elect to contract with an MCO 
or PIHP

[[Page 27560]]

without authorizing IMD--or any other service(s)--as an in lieu of 
service on the terms identified in this rule. In such cases involving 
IMD, the payment of the capitation rate for a month in which an 
enrollee is a patient of an IMD for any period of time is not 
consistent with this rule, and therefore not eligible for FFP.
    Comment: Several commenters specified that states using existing in 
lieu of authority to cover IMD services should be permitted to continue 
using the authority as currently authorized in approved contracts and 
waivers, that is, without the limitations discussed in the proposed 
rule. Several commenters also stated opposition to any actual or 
implied proposed limitation on the use of in lieu of services if those 
services have been determined, as demonstrated to CMS by the state and 
their actuary, to be a cost-effective substitute service that the 
member agrees to and the managed care plan willingly provides. 
Commenters stated that eliminating or limiting current in lieu of 
service flexibility would result in program disruptions, increased 
costs to states and the federal government, and potentially decreased 
access to necessary behavioral health services.
    Response: We acknowledge that current state practices vary 
regarding the use of IMDs as an in lieu of setting for covered 
inpatient mental health or substance use disorder services. This 
provision, as finalized, represents the only permissible approach for 
states to apply the in lieu of services approach for enrollees in an 
IMD given the statutory prohibition on FFP. States must be in 
compliance with these provisions for contracts starting on or after 
July 1, 2017.
    Comment: Many commenters were concerned about the length of stay of 
15 days or less for inpatient and sub-acute crisis residential 
psychiatric and substance use disorder care proposed in Sec.  438.3(u) 
for which capitated payments to managed care plans would be permitted. 
These commenters expressed concern that the selection of a 15-day 
length of stay limit appeared arbitrary, not aligned with federal 
Medicare definitions of short-term hospitalization, solely based on 
data from the Medicaid Emergency Psychiatric Demonstration which is 
limited to severe psychiatric conditions and not reflective of managed 
care, or otherwise not clinically appropriate. Many of these commenters 
recommended alternative length of stay limitations for this provision, 
including 15 days with a 7-day extension option based on medical 
necessity, 21 days, 25 days to align with the average length of stay in 
under Medicare for long-term care hospitals, and 30 days. In addition, 
many of these commenters requested CMS further explain the basis for 
proposing a 15-day length of stay limitation.
    Response: In order for a capitation payment to be made by the state 
to the MCO or PIHP for an enrollee in an IMD, this provision has to 
define a reasonable short-term length of stay in an IMD for individuals 
with an inpatient level of care need for psychiatric or SUD services. 
This is because there must be some period of time within the month 
covered by the capitation payment that the enrollee is not a patient in 
an IMD and may receive other Medicaid covered services. As explained in 
the preamble of the proposed rule, the selection of a 15-day length of 
stay was based on data from several sources. For instance, initial 
results from the Medicaid Emergency Psychiatric Demonstration 
evaluation provides data reflecting certain psychiatric stays in IMDs 
in the Medicaid population. The evidence from the Demonstration 
suggests that the average length of stay was 8.2 days.\7\ In addition, 
the proposed 15-day length of stay is supported by Market Scan Medicaid 
2013 inpatient records data for inpatient behavioral health hospital 
stays, which encompass both inpatient mental health stays and inpatient 
substance use disorder stays. This evidence suggests that the average 
length of mental health inpatient stays was 10.2 days, and that over 90 
percent of mental health inpatient stays were 15 days or shorter. This 
evidence also suggests that the average length of substance use 
disorder inpatient stays was 5.9 days, and that over 90 percent of 
inpatient substance use disorder stays were 10 days or shorter. In 
addition, claims data from 2012 show that FFS Medicare beneficiaries 
had an average length of stay of 12.8 days in inpatient psychiatric 
facilities, according to analysis by the Medicare Payment Advisory 
Commission. Based on this analysis, we are finalizing the 15-day per 
month, per admission timeframe.
---------------------------------------------------------------------------

    \7\ CMS, ``Report to Congress on the Evaluation of the Medicaid 
Emergency Psychiatric Demonstration'' (December 1, 2013), at pg. 11, 
available at https://innovation.cms.gov/Files/reports/MEPD_RTC.pdf.
---------------------------------------------------------------------------

    Comment: Many commenters were concerned that the length of stay of 
15 days or less for inpatient and sub-acute crisis residential care 
proposed in this provision is not appropriate for substance use 
disorder care in particular. Some commenters recommended that the 
proposed 15-day length of stay limit be extended (for example, to 30 
days) for substance use disorder exclusively. Other commenters 
recommended that CMS include residential substance use disorder care in 
the provision.
    Response: As explained in response to a previous comment, the 
proposed 15-day length of stay limitation for inpatient substance use 
disorder care is supported by recent Medicaid managed care inpatient 
substance use disorder stay hospital records data. We agree it is 
important to address the needs of individuals with substance use 
disorder who require longer lengths of stay in short-term, non-hospital 
based residential treatment settings. To that end, we recently issued a 
State Medicaid Director letter (SMDL) (#15-003) regarding opportunities 
to design service delivery systems for individuals with substance use 
disorder. See https://www.medicaid.gov/federal-policy-guidance/downloads/SMD15003.pdf. The letter outlined a new opportunity for 
demonstration projects approved under section 1115(a) of the Act, to 
ensure that a continuum of care is available to individuals with 
substance use disorder. In the letter, CMS describes the ability to 
receive FFP for short-term inpatient and residential substance use 
disorder treatment, including in facilities that meet the definition of 
an IMD, provided that such coverage complements broader substance use 
disorder system reforms and specific program requirements are met. The 
letter defines short-term inpatient stays as 15 days or less and 
occurring in a medically managed setting (ASAM Level 4.0), and defines 
short-term residential stays as an average of 30 days and occurring in 
a clinically managed or medically monitored setting (ASAM Levels 3.1, 
3.3, 3.5 and 3.7). Through this section 1115(a) demonstration 
opportunity, state Medicaid programs can cover short-term residential 
substance use disorder treatment beyond a 15-day length of stay.
    Comment: Some commenters raised concern that the proposed IMD 
provision that would permit the payment of capitation payments for 
enrollees with a short term stay of no more than 15 days within the 
month would violate MHPAEA as a treatment limitation. Other commenters 
asked if MHPAEA requires the use of IMDs as a setting to provide mental 
health or SUD services.
    Response: First, this provision is a payment limitation on the 
MCO's or PIHP's ability to receive a capitation payment that is 
eligible for FFP for an enrollee with a short term stay in an IMD 
rather than a treatment limitation for mental health or SUD services. 
As stated previously, under the in lieu of approach authorized under 
this

[[Page 27561]]

proposal, the alternative setting (for example, an IMD) for the short 
term stay of no more than 15 days within the month must be a medically 
appropriate substitute for covered inpatient stays under the state 
plan. If such an alternative is not appropriate for the needs of the 
enrollee, the MCO or PIHP must admit the enrollee to a general hospital 
instead of the IMD and/or provide the other covered services that are 
medically necessary and appropriate. We also point out that MHPAEA does 
not require an IMD to be used as a setting for covered mental health or 
SUD services. Rather, the provisions of MHPAEA require inpatient 
services for mental health or SUD services to be provided at a level 
consistent with coverage of medical or surgical benefits, but the 
location or setting for those services is not dictated under that 
federal law. In order for an MCO or PIHP to receive a capitation 
payment that is eligible for FFP for an enrollee with a short term stay 
in an IMD, the provisions at Sec.  438.6(e) apply. Specifically, the 
requirements for in lieu of services at Sec.  438.3(e)(2)(i) through 
(iii) must be met and, for purposes of rate setting as specified at 
Sec.  438.6(e), the state may use the utilization of services provided 
to an enrollee under this section when developing the inpatient 
psychiatric or substance use disorder component of the capitation rate, 
but must price utilization at the cost of the same services through 
providers included under the state plan.
    Comment: Some commenters raised concern that the proposed IMD 
provision could require the managed care plan to pay for as many as 30 
consecutive days at an IMD if the stay spans two months. Commenters 
recommended that CMS clarify that the managed care plan shall not be 
required to pay for care at an IMD beyond the 15th day. One commenter 
recommended that CMS clarify whether a stay that begins in one month 
and ends in the following month is viewed as a single episode or for 
the purposes of monthly capitation payments may be viewed as the number 
of inpatient days within each capitation month. Commenters also 
recommended that CMS limit the managed care plan's covered benefit to 
60 days per calendar year.
    Response: The appropriate application of the in lieu of services 
policy for use of an IMD requires the MCO or PIHP to determine if the 
enrollee has an inpatient level of care need that necessitates 
treatment for no more than 15 days. If the managed care plan (or 
physician) believes that a stay of longer than 15 days is necessary or 
anticipated for an enrollee, the use of this specific in lieu of 
service is likely not appropriate if Medicaid coverage is going to be 
continued because of the prohibition in subsection (B) following 
section 1902(a)(29) of the Act. As we explained in connection with this 
proposal (80 FR 31118), it is possible that an MCO or PIHP could 
receive two capitation payments for consecutive months if the length of 
stay could extend beyond 15 days, with no more than 15 days occurring 
during each month. For the purpose of determining whether a capitation 
payment may be made for an enrollee, the focus is the number of 
inpatient days within the period covered by the monthly capitation 
payment. We decline to accept the recommendation that the managed care 
plan's covered benefit for stays in an IMD be limited to 60 days per 
calendar year. We restate that managed care plans are not required to 
use flexibility described here. As we proposed (80 FR 31117), the 
contract may not require the managed care plan to use IMDs; the 
contract may only authorize in lieu of services that the MCO or PIHP 
may make available to enrollees FFP for capitation payments to managed 
care plans that provide coverage of services for enrollees aged 21 to 
64 that are a patient in an IMD is available only as described in this 
final rule.
    Comment: A few commenters stated that the preamble indicates that a 
state will be required to monitor beneficiary IMD lengths of stay on a 
monthly basis, and if such a stay lasts 15 days or longer in a month, 
to seek recoupment of its total capitation payment made to the managed 
care plan for that month. Commenters noted that requiring states to 
recoup capitation payments made to MCOs and PIHPs for an enrollee with 
an IMD stay that exceeds 15 days will require significant retroactive 
adjustments and create major financial uncertainty. Commenters also 
stated that such an approach would disrupt program operations. As an 
alternative to this approach, commenters recommended that CMS require 
states to have reporting requirements and appropriate compliance 
actions in their managed care plan contracts to enforce the IMD 
provision. Commenters also recommended that CMS could require a hard 
limit on the number of IMD days included in the state's monthly 
capitation payment but allow individuals to continue to be enrolled in 
care coordination in the event that an individual's stay exceeds 15 
days.
    Response: We acknowledge that this provision requires states to 
monitor the MCO's or PIHP's use of IMDs as an in lieu of service to 
ensure that capitation payments were appropriately made and that claims 
for FFP associated with those capitation payments are filed only when 
consistent with this rule. However, to ensure that the operation of 
this provision remains consistent with paragraph (B) following section 
1905(a)(29) of the Act, such oversight is necessary on the part of the 
state, and the MCO or PIHP must use sound judgment when offering the 
IMD as an alternative setting for enrollees with an inpatient level of 
care need for psychiatric or SUD treatment. The provisions in Sec.  
438.6(e) specify the federal requirements to permit capitation payments 
that are eligible for FFP to be made in this context. States have the 
flexibility under this rule and applicable state law to design contract 
terms to ensure compliance by MCOs or PIHPs with the parameters of this 
final rule for using IMDs an in lieu of service. As stated above in 
response to comments, the capitation payment that is made for enrollees 
that fall under this provision represents the full capitation rate for 
that enrollee's rate cell. If an enrollee has a length of stay for more 
than 15 days within the period covered by the monthly capitation 
payment, no capitation payment may be made for that enrollee under a 
Medicaid managed care program regulated under 42 CFR part 438. We note, 
however, that states may also pay independently for services provided 
to patients in IMDs. We emphasize that the statutory exclusion was 
designed to assure that states, rather than the federal government, 
continue to have principal responsibility for funding inpatient 
psychiatric services.
    Comment: A few commenters recommended that CMS exclude residential 
addiction treatment programs from the definition of IMD. Other 
commenters recommended that CMS exclude substance use disorders from 
the definition of ``mental disease'' for the purposes of determining if 
a treatment facility is an IMD. A few commenters recommended that CMS 
clarify that the IMD provision is not applicable to inpatient 
psychiatric hospital services for individuals under age 21 as defined 
in Sec.  440.160.
    Response: Under section 1905(i) of the Act, an Institution for 
Mental Diseases is defined as a hospital, nursing facility, or other 
institution of more than 16 beds that is primarily engaged in providing 
diagnosis, treatment, or case of persons with mental diseases, 
including medical attention, nursing care, and related services. The 
regulation at Sec.  435.1010 repeats this definition with an additional 
provision that an IMD is

[[Page 27562]]

identified by its ``overall character'' as a facility established and 
maintained primarily for the care and treatment of individuals with 
mental diseases, regardless of its licensure.
    We consider facilities treating substance use disorder (including 
addiction) to be within the definition of an ``institution for mental 
disease,'' provided the other relevant criteria are met as set forth in 
the applicable law and guidance (for example, subsection C of Section 
4390 of the State Medicaid Manual, a body of sub-regulatory guidance 
designed to provide states with policies, procedures and instructions 
for administering their Medicaid programs). The additional criteria, 
which are not intended to be exhaustive, include whether the facility 
is licensed as a psychiatric facility; the facility is accredited as a 
psychiatric facility; the facility is under the jurisdiction of the 
state's mental health authority; the facility specializes in providing 
psychiatric/psychological care and treatment; and the current need for 
institutionalization for more than 50 percent of all the patients in 
the facility results from mental diseases. To the extent that the 
substance use disorder treatment services delivered are covered by the 
Medicaid program, the services are considered medical treatment of a 
mental disease. Facilities with more than 16 beds primarily engaged in 
providing this type of treatment would most likely meet the definition 
of an IMD. CMS is available to provide additional clarification on 
these points. We also note here that Medicaid-covered services provided 
in facilities meeting qualifications of the inpatient psychiatric 
benefit for individuals under the age of 21 are eligible for 
reimbursement under section 1905(a)(16) of the Act. These services are 
an exception to the IMD exclusion, regardless of the bed size of the 
facility.
    Comment: Several commenters cited that lack of Medicaid coverage 
for acute short-term treatment services provided in facilities that are 
IMDs creates a significant barrier to accessing necessary care for 
individuals.
    Response: We understand that there are access issues for short-term 
inpatient psychiatric and SUD treatment. We attempt to address the 
access issues noted above through several strategies. In addition to 
proposing Sec.  438.6(e), we recently released an SMDL #15-003 that 
would allow states to request a section 1115(a) demonstration to 
receive federal matching funding for expenditures for individuals 
residing in IMDs to treat SUD. See http://www.medicaid.gov/federal-policy-guidance/downloads/SMD15003.pdf.
    Comment: Other commenters stated that the IMD exclusion presents a 
parity issue for Medicaid beneficiaries. Several of these commenters 
recommended that CMS should clarify how parity and the IMD exclusion 
co-exist and explicitly state that services typically provided in IMDs 
remain subject to parity. Other commenters suggested that the proposed 
15-day length of stay limit is inconsistent with parity standards and 
that that outpatient and inpatient services should be provided to 
people living with mental illness or substance use disorders in an 
equitable and non-discriminatory manner. One commenter suggested the 
15-day length of stay limit imposes a quantitative treatment limitation 
on inpatient behavioral health services that the State would be 
required to include in its analysis of compliance with proposed Sec.  
440.395.
    Response: We note that parity issues are not within the scope of 
this regulation and point commenters to the March 30, 2016 final rule 
(81 FR 18390) for a discussion of parity standards as applied to 
Medicaid, Medicaid ABPs, and CHIP managed care. Paragraph (B) following 
section 1905(a)(29) of the Act provides that FFP is not available for 
any medical assistance under Title XIX for services provided to an 
individual ages 21 to 64 who is a patient in an IMD facility. Under 
this broad exclusion, no FFP is available for the cost of services 
provided either inside or outside the IMD while the individual is a 
patient in the facility. States have the option, using state programs 
other than the Medicaid program, of providing inpatient psychiatric and 
SUD services in IMDs. This rule permits payment of capitation rates 
under the Medicaid program to MCOs and PIHPs for a month for an 
enrollee when only part of that period is spent by the enrollee as a 
patient in an IMD because the IMD is used as a substitute setting for 
otherwise covered services.
    We also note that the IMD exclusion is not a non-quantitative 
treatment limit. Treatment and the provision of covered services maybe 
furnished in a different setting consistent with applicable parity 
standards. Further, the IMD exclusion is not a mandatory standard for 
provider admission to participate in a network. In addition, the 15-day 
length of stay standard in this rule is not a quantitative treatment 
limitation on treatment. It is a rule related to the payment of FFP for 
capitation rates to MCOs and PIHPs using substitute service settings; 
medically necessary treatment of enrollees in a non-IMD setting (for 
example, in a psychiatric ward of a general hospital) may continue for 
greater than 15 days and be eligible for FFP.
    Comment: Some commenters stated that the proposed length of stay of 
15 days or less for inpatient hospital facilities or sub-acute 
facilities providing crisis residential services may result in 
increased readmissions to those facilities. Specifically, these 
commenters suggested that the 15-day length of stay limitation could 
result in disruptions in treatment by creating a financial incentive to 
discharge individuals before it is medically appropriate to do so and 
readmit those individuals in the following month to ensure managed care 
plans' continued eligibility for the receipt of capitation payments.
    Response: We share this concern about providing quality care and 
preventing unnecessary readmissions. States may consider incorporating 
provisions into their managed care contracts designed to address 
potentially undesirable financial incentives, such as prohibitions on 
paying for preventable readmissions or readmissions occurring within a 
specified timeframe. In addition, states and managed care plans should 
work to ensure successful discharges from inpatient and sub-acute 
facilities, including successful transitions to outpatient care. States 
and managed care plans may use quality measures to track readmissions, 
discharges and transitions. To that end, we may release subregulatory 
guidance recommending specific measures for this purpose.
    Comment: Several commenters recommended that CMS require IMDs 
receiving federal Medicaid reimbursement to provide data on specific 
quality measures concerning inpatient care and linkages with community 
services following discharge. Commenters recommended measures such as: 
documentation of follow[hyphen]up mental health services in the 
community within 14 days of discharge from the hospital, hospital 
readmission rates following discharge at specified intervals, arrests 
following discharge, patient experiences and satisfaction during 
hospitalization, and use of seclusion and restraints during 
hospitalization. One commenter recommended that CMS review the outcomes 
of this provision after a period of 3 years to determine whether 
Medicaid costs were reduced and if individuals were enabled to 
stabilize their mental illnesses or substance use disorders following a 
hospitalization and return to independent living in the community. One 
commenter recommended that CMS carefully monitor the use of the 15 day 
per month

[[Page 27563]]

allowance to prevent periodic inpatient care being overused or used as 
a substitute for high quality accessible community, home, and work 
based behavioral health services.
    Response: The final rule does not regulate IMDs and CMS has not 
identified authority in this rule to regulate IMDs. As discussed in the 
proposed rule (80 FR 31117), this provision is intended to provide 
states with flexibility to address concerns about ensuring access to 
and availability of short-term inpatient psychiatric and SUD services 
in Medicaid programs. We encourage states to identify and track 
relevant measures including behavioral health measures but requiring 
states to collect specific performance measures related to IMDs is not 
within the scope of this regulation. Should we elect to identify 
national performance measures under the authority of Sec.  
438.330(a)(2) of this final rule, we will take these recommendations 
into consideration during the public notice and comment process. We 
also note that we have required states, through our section 1115(a) 
demonstration authority, to collect and analyze measures that other 
states may want to use for beneficiaries with behavioral health needs 
as part of their evaluation of these services. Evaluation of the use of 
in lieu of services in this context or more broadly could be part of a 
state's quality strategy for the managed care program under Sec.  
438.340, although we decline to require such evaluation in regulation.
    Comment: A few commenters recommended that CMS allow the actual 
costs of the IMD, in the absence of inpatient hospital costs, as a 
substitute in the encounter data used to set rates. One commenter 
stated that using 15 days to project rates is too high. The commenter 
recommended that CMS require states to set rates based on 10 days and 
allow for the additional 5 days as an outlier until each state can 
analyze its data and confirm an average length of stay. A few 
commenters stated concerns regarding the refusal to allow states to 
utilize the IMD costs as a proxy in setting actuarially sound rates and 
recommended that CMS allow such an approach. A few commenters 
recommended that CMS clarify that the IMD provision is subject to the 
actuarial soundness requirements and rate development standards 
included in the proposed regulation.
    Response: Consistent with our proposal (80 FR 31118), the 
utilization of services used for rate setting (that is, both historical 
and projected utilization) should include the provision of covered 
services when such services are provided to an enrollee who is a 
patient in an IMD consistent with this rule (meaning that the terms of 
Sec.  438.6(e) are all met); however the cost of such services should 
be priced at the cost of covered inpatient settings to remain 
consistent with the statutory prohibition of FFP. States and their 
actuaries may rely on actual utilization in an IMD of inpatient 
psychiatric or substance use disorder stays when setting the capitation 
rates, so long as the utilization in an IMD does not exceed 15 days per 
month per enrollee. This provision does not require states and their 
actuaries to apply a blanket utilization assumption of 15 days. 
Utilization of inpatient psychiatric and SUD services rendered outside 
of the IMD are also taken into account when developing that component 
of the capitation rate. We emphasize that the requirements for the 
development and documentation of actuarially sound capitation rates in 
Sec. Sec.  438.4-438.7 apply to this provision; however, Sec.  438.6(e) 
sets forth the specific requirements for pricing the utilization of 
services rendered in an IMD.
    Comment: One commenter recommended that CMS include a community 
transition unit at Sec.  438.3(u). The commenter also recommended that 
CMS invest in a short-term community living skills training program to 
ensure success of community transitions for longer-term 
institutionalized consumers with learned dependency habits.
    Response: While we are unclear on the commenter's definition of 
community transition units, we recognize that inpatient diversion 
services play an important role in the treatment of individuals with 
mental health and substance use disorder service needs. However, this 
provision is solely intended to address the use of in lieu of services 
for short term care (including sub-acute crisis services) for 
individuals with inpatient level of care needs. We acknowledge the 
importance of implementing services and supports for individuals 
transitioning into community settings, but the explicit inclusion of 
community transition units would be outside the scope of this 
provision. CMS is considering releasing subregulatory guidance that 
provides greater clarity regarding sub-acute crisis services.
    Comment: One commenter recommended that CMS clarify whether the 
flexibility offered at Sec.  438.3(u) applies to Medicaid managed care 
plans that are not capitated. One commenter recommended that CMS 
clarify whether Sec.  438.3(u) would also apply to a Provider Led 
Entity in its role as a manager of Medicaid services. One commenter 
recommended that CMS allow states to extend this arrangement to the 
managed care enrollees who receive behavioral health services through a 
FFS carve-out.
    Response: We interpret the commenter to question whether the 
provision at Sec.  438.3(u) would apply to non-risk PIHPs as by 
definition, MCOs must be under comprehensive risk contracts, and non-
risk PIHPs receive a monthly capitation payment that is reconciled to 
state plan payment rates under Sec.  438.812. Section 438.6(e) is 
limited to risk-based MCOs and PIHPs; it is not applicable to FFS 
Medicaid delivery systems or non-risk delivery systems. Thus, this 
section is inapplicable to non-risk PIHPs that provide mental health or 
substance use disorder services. The use of in lieu of services only 
applies to risk contracts.
    Comment: A few commenters recommended that CMS eliminate the state 
option to allow behavioral health services to be carved out of Medicaid 
managed care benefits, as this is a barrier to treating the whole 
person and to achieving the goal of better care, healthier people, and 
lower costs. A few commenters stated that these carve-out arrangements 
create barriers to the integration of behavioral and physical health 
care and inhibit the sharing of information across care settings.
    Response: This comment is outside the scope of the proposed rule. 
However, while we concur with the commenters that integrated care 
eliminates many of the challenges posed by carving out services from a 
managed care program, we decline to prohibit such arrangements out of 
deference to the state's ability to design its Medicaid program.
    After consideration of public comments, we are finalizing the 
regulation text for this provision at Sec.  438.6(e) substantially as 
proposed, with the following modifications:
     Clarified that Sec.  438.6(e) applies to both psychiatric 
and substance use disorder services;
     Specified that the provision was limited to enrollees aged 
21-64;
     Incorporated requirements for in lieu of services in Sec.  
438.3(e)(2)(i) through (iii);
     Described the rate setting requirements for in lieu of 
services in an IMD consistent with our proposal (80 FR 31118).
t. Recordkeeping Requirements (Proposed as Sec.  438.3(v), Finalized as 
Sec.  438.3(u))
    In paragraph (v), we proposed minimum recordkeeping requirements 
for MCOs, PIHPs, PAHPs, and

[[Page 27564]]

subcontractors, as applicable, of at least 6 years for data, 
documentation and information specified in this part. Specifically, we 
proposed that MCOs, PIHPs, PAHPs, and subcontractors retain enrollee 
grievance and appeal records as specified in Sec.  438.416, base data 
as specified in Sec.  438.5(c), MLR reports as specified in Sec.  
438.8(k), and the documentation specified in Sec. Sec.  438.604, 
438.606, 438.608, and 438.610. We made this proposal under our 
authority in section 1902(a)(4) of the Act to mandate methods of 
administration that are necessary for the efficient operation of the 
state plan. We requested comment on the proposed length of record 
retention; specifically, whether 6 years is consistent with existing 
state requirements on managed care plans for record retention and 
whether we should adopt a different timeframe. We noted that MA 
requires MA organizations to retain records for a period of 10 years at 
Sec.  422.504(d).
    We received the following comments in response to proposed Sec.  
438.3(v).
    Comment: Several commenters supported the proposed recordkeeping 
requirement of 6 years at Sec.  438.3(v). One commenter stated that 6 
years is not a standard accounting practice and recommended that CMS 
adopt 7 years as the recordkeeping requirement. One commenter stated 
that CMS should align the recordkeeping requirement with Sec.  
438.230(c)(3)(iii) regarding the audit and inspection timeframe of 10 
years. Further, one commenter stated that under the False Claims Act at 
31 U.S.C. 3731(b)(2), claims may be brought up to ``10 years after the 
date on which the violation is committed.'' The commenter recommended 
that CMS require managed care plans and subcontractors to retain 
documentation for a period of 10 years for consistency with the False 
Claims Act as well as MA's record retention requirement.
    Response: We agree with commenters that the recordkeeping 
requirement at Sec.  438.3(v) should align with Sec.  
438.230(c)(3)(iii) regarding the audit and inspection timeframe of 10 
years. Further, since the 10 year timeframe would align with both the 
False Claims Act at 31 U.S.C. 3731(b)(2) and MA, we believe it is 
appropriate to align Sec.  438.3(v) with the 10 year requirement. We 
are finalizing the regulatory text to adopt this recommendation.
    After consideration of the public comments, we are modifying the 
regulatory text to revise the 6 year recordkeeping requirement to 10 
years and redesignating this paragraph at (u) to account for the move 
of proposed Sec.  438.3(u) relating to capitation payments for 
enrollees with a short term stay in an IMD to Sec.  438.6(e).
3. Setting Actuarially Sound Capitation Rates for Medicaid Managed Care 
Programs (Sec. Sec.  438.2, 438.4, 438.5, 438.6, and 438.7)
    Building on a decade of experience with states, we proposed to 
improve the effectiveness of the regulatory structure to better assure 
the fiscal integrity, transparency and beneficiary access to care under 
the Medicaid program and to promote innovation and improvement in the 
delivery of services through a comprehensive review of Medicaid managed 
care capitation rates. The overarching goal behind our proposed 
revisions to the rate setting framework (proposed in Sec. Sec.  438.4 
through 438.7) was to reach the appropriate balance of regulation and 
transparency that accommodates the federal interests as payer and 
regulator, the state interests as payer and contracting entity, the 
actuary's interest in preserving professional judgment and autonomy, 
and the overarching programmatic goals--shared by states and the 
federal government--of promoting beneficiary access to quality care, 
efficient expenditure of funds and innovation in the delivery of care. 
We also noted that requiring more consistent and transparent 
documentation of the rate setting process would allow us to conduct 
more efficient reviews of the rate certification submissions.
    Section 1903(m)(2)(A)(iii) of the Act permits federal matching 
dollars for state expenditures to a risk bearing entity for Medicaid 
services when such services are provided for the benefit of individuals 
eligible for benefits under this title in accordance with a contract 
between the state and the entity under which the prepaid payments to 
the entity are made on an actuarially sound basis and under which the 
Secretary must provide prior approval for contracts [meeting certain 
value thresholds].
    We relied on the following principles of actuarial soundness to 
inform the modernized rate setting framework in this final rule. First, 
capitation rates should be sufficient and appropriate for the 
anticipated service utilization of the populations and services covered 
under the contract and provide appropriate compensation to the managed 
care plans for reasonable non-benefit costs. Built into that principle 
is the concept that an actuarially sound rate should result in 
appropriate payments for both payers (the state and the federal 
government) and that the rate should promote program goals such as 
quality of care, improved health, community integration of enrollees 
and cost containment, where feasible. Second, an actuarial rate 
certification underlying the capitation rates should provide sufficient 
detail, documentation, and transparency of the rate setting components 
set forth in this regulation to enable another actuary to assess the 
reasonableness of the methodology and the assumptions supporting the 
development of the final capitation rate. Third, a transparent and 
uniformly applied rate review and approval process based on actuarial 
practices should ensure that both the state and the federal government 
act effectively as fiscal stewards and in the interests of beneficiary 
access to care.
a. Definitions (Sec.  438.2)
    We proposed to define ``actuary'' to incorporate standards for an 
actuary who is able to provide the certification under current law at 
Sec.  438.6(c); that is, that the individual meets the qualification 
standards set by the American Academy of Actuaries as an actuary and 
follows the practice standards established by the Actuarial Standards 
Board. We also proposed that where the regulation text refers to the 
development and certification of the capitation rates, and not the 
review or approval of those rates by CMS, the term actuary refers to 
the qualified individual acting on behalf of the state. We explained 
that an actuary who is either a member of the state's staff or a 
contractor of the state could fulfill this role so long as the 
qualification and practice standards are also met. We did not receive 
comments on the proposed definition for ``actuary'' and will finalize 
the definition as proposed without modification.
    We proposed to modify the existing definition of ``capitation 
payment'' by removing references to ``medical'' services in recognition 
of the fact that states are contracting with MCOs, PIHPs, and PAHPs for 
LTSS, which are not adequately captured in the existing definition of 
capitation payments that refers only to medical services.
    We received the following comments in response to the proposed 
modification to the definition of ``capitation payment.''
    Comment: One commenter agreed with the removal of ``medical'' to 
modify ``services'' in the definition of a capitation payment but 
suggested that CMS insert ``health care'' before ``services'' to be 
more reflective of the type and range of services that are offered 
without becoming too broad. One commenter requested confirmation that 
the definition is consistent with sections 2.3 (definition of 
capitation

[[Page 27565]]

rate) and 3.2.2 (structure of Medicaid managed care capitation rates) 
of the ASOP No. 49 and section AA.4 of the CMS Rate Setting Checklist.
    Response: We appreciate the commenter's suggestion but decline to 
add ``health care'' as that term would have a similar effect to 
retaining the term ``medical'' as a modifier of ``services. For 
example, residential or employment supports may be provided through a 
managed LTSS program and, thereby included in capitation payments, and 
those services do not fall within a generally accepted understanding of 
the term ``health care.'' The proposed definition of a capitation 
payment links services to the state plan, which would also include 
services authorized under a waiver authority (for example, section 
1915(c) of the Act), and is sufficient to address the scope of services 
represented in a capitation payment.
    The proposed rule made a minor modification to the definition of a 
capitation payment and the definition is consistent with sections 2.3 
and 3.2.2 of ASOP 49. We note that section 3.2.2 of the ASOP No. 49 
refers primarily to the development of rate cells and explains that 
capitation payments are made according to rate cell. In addition, to 
the extent any inconsistencies Section AA.4 of the CMS Ratesetting 
Checklist also addresses rate cells, we refer commenter to our response 
to comments on the definition of a ``rate cell.'' Ultimately, the 
definitions are consistent. As stated in other forums, the CMS 
Ratesetting Checklist is an internal tool for CMS' use when reviewing 
rate certifications. The applicability or need to update that tool 
based on changes in these regulations is outside the scope of this 
rule. States, their actuaries, and managed care plans should rely on 
the regulatory requirements related to rate setting in Sec. Sec.  
438.4-438.7 when developing capitation rates and sub-regulatory rate 
development guidance published by CMS (for example, 2016 Medicaid 
Managed Care Rate Development Guide).
    After consideration of the public comments, we are finalizing the 
definition of ``capitation payment'' as proposed without modification.
    We proposed to define a ``material adjustment'' as one that, in the 
objective exercise of an actuary's judgment, has a significant impact 
on the development of the capitation rate. We noted that material 
adjustments may be large in magnitude, or be developed or applied in a 
complex manner. The actuary developing the rates should use reasonable 
actuarial judgment based on generally accepted actuarial principles 
when assessing the materiality of an adjustment. We did not receive 
comments on the definition for ``material adjustment'' and will 
finalize as proposed without modification.
    We also proposed to add a definition for ``rate cells.'' The use of 
rate cells is intended to group people with more similar 
characteristics and expected health care costs together to set 
capitation rates more accurately. The rate cells should be developed in 
a manner to ensure that an enrollee is assigned to one and only one 
rate cell. That is, each enrollee should be categorized in one of the 
rate cells and no enrollee should be categorized in more than one rate 
cell.
    We received the following comments in response to our proposal to 
define ``rate cells.''
    Comment: We received several comments on the proposed definition of 
a ``rate cell'' in Sec.  438.2. One commenter suggested that the 
definition of a rate cell be broadened to accommodate a wider set of 
payment structures and that the proposed definition that an enrollee 
could only be in one rate cell did not recognize existing practices. 
For example, in some states an enrollee can be in multiple rate cells 
because states have different contracts covering different benefits. 
Some commenters provided that a state may pay the medical acute benefit 
as one rate cell and the LTSS as an add-on rate cell and suggested that 
the definition be modified to provide that an enrollee would only be in 
one rate cell for each unique set of benefits. Another commenter noted 
that the definition of rate cell does not explicitly mention 
eligibility category and requested clarification as to whether 
eligibility category was still required in the development of rate 
cells.
    Response: To address the commenters who raised the issue that 
enrollees may be in more than one rate cell in states that have 
separate managed care contracts for different benefits, we have 
modified the language that no enrollee should be categorized in more 
than one rate cell ``under the contract.'' For those states that would 
categorize an enrollee under two rate cells--one for acute medical 
services and one for LTSS--under the same contract, we have modified 
the definition to acknowledge that enrollees may be in different rate 
cells for each unique set of mutually exclusive benefits under the 
contract. We have added ``eligibility category'' to the list of 
potential criteria for grouping enrollees under a rate cell and restate 
that the list of characteristics represent the range of permissive 
groupings and does not require that each characteristic be applied to 
the development of rate cells for populations under the contract.
    Comment: One commenter requested that CMS clarify its expectation 
for development of an amount paid outside the capitated rate, for 
example delivery kick payments. The commenter requested clarification 
that these types of payments that are outside the capitation rate will 
continue to be allowed.
    Response: Kick payments are permissible under this final rule as 
such payments are capitation payments in addition to the base 
capitation payment per rate cell and are subject to the rate 
development and rate certification documentation requirements in this 
rule.
    After consideration of the public comments, we are finalizing the 
definition of ``rate cell'' to recognize that enrollees may be in 
different rate cells for each set of mutually exclusive benefits under 
the contract and to include eligibility category to the criteria for 
creating rate cells.
    Comment: One commenter suggested that CMS add a definition for a 
``rating period'' in Sec.  438.2 similar to the reference to a rating 
period in the definition of a ``MLR reporting year'' at Sec.  438.8(b). 
The commenter stated that the addition of a definition for ``rating 
period'' would avoid confusion in the regulations between the period 
for which capitation rates are being developed and the historical data 
period(s) supplying the base data in the rate development process.
    Response: We concur with the commenter that the inclusion of a 
definition for ``rating period'' would improve readability as the term 
appears in both Sec.  438.5(c)(1) relating to base data for rate 
setting purposes and in the definition of MLR reporting year in Sec.  
438.8(b). Therefore, we will finalize Sec.  438.2 to include a 
definition for ``rating period'' as ``a period of 12 months selected by 
the State for which the actuarially sound capitation rates are 
developed and documented in the rate certification submitted to CMS as 
required by Sec.  438.7(a).''
b. Actuarial Soundness Standards (Sec.  438.4)
    Consistent with the principles of actuarial soundness described 
herein, we proposed to add a new Sec.  438.4 that built upon the 
definition of actuarially sound capitation rates currently at Sec.  
438.6(c)(i) and established standards for states and their actuaries. 
In Sec.  438.4(a), we proposed to define actuarially sound capitation 
rates as rates that are projected to provide for all reasonable, 
appropriate, and attainable

[[Page 27566]]

costs under the terms of the contract and for the time period and 
population covered under the contract. We explained that the rate 
development process should be conducted and rates developed in 
accordance with the proposed standards for approval of rates in Sec.  
438.4(b). We provided that under this provision, costs that are not 
reasonable, appropriate, or attainable should not be included in the 
development of capitated rates, (see 80 FR 31119).
    We received the following comments on proposed Sec.  438.4(a).
    Comment: One commenter requested that CMS clarify that actuarial 
soundness applies not to individual components of rates (for example, 
the non-benefit component), but to the total capitation rate per rate 
cell. One commenter stated that it was unclear to what CMS would 
classify as reasonable, appropriate, and attainable costs.
    Response: Generally accepted actuarial principles and practices 
apply to each rate development standard specified in Sec.  438.5 used 
in the rate setting process, resulting in the actuary certifying that 
the capitation rate per rate cell under the contract is actuarially 
sound as defined in Sec.  438.4(a). The total capitation rate per rate 
cell must be projected to provide for all reasonable, appropriate, and 
attainable costs, while individual components of the rate cell must be 
developed in accordance with Sec.  438.5. It is unclear what additional 
clarification the commenter requests regarding ``reasonable, 
appropriate, and attainable costs,'' as actuaries have conducted their 
work based on this definition for a considerable length of time. It is 
difficult for us to provide an exhaustive list of ``reasonable, 
appropriate, and attainable costs'' as that determination is based on 
the obligations on the managed care plan under the particular contract 
and the actuary's professional judgment using generally accepted 
actuarial principles and practices.
    Comment: A commenter requested clarification as to whether the 
actuarial soundness and rate development standards in Sec. Sec.  438.4 
and 438.5, respectively, apply to Financial Alignment Demonstrations 
under section 1115A authority.
    Response: Yes, upon the effective and applicable compliance dates 
of this final rule, these requirements apply to the Medicaid portion of 
the capitation rate paid under section 1115A Financial Alignment 
demonstrations. Section III.A.2 of the Memorandum of Understanding 
(MOU) for Financial Alignment Demonstrations specifies that Medicaid 
managed care requirements under Title XIX and 42 CFR part 438 apply 
unless explicitly waived. Our consistent policy for Financial Alignment 
Demonstrations is to maintain the actuarial soundness requirements.
    After consideration of the public comments, we are finalizing Sec.  
438.4(a) as proposed.
    In Sec.  438.4(b), we proposed to set forth the standards that 
capitation rates must meet and that we would apply in the review and 
approval of actuarially sound capitation rates. In Sec.  438.4(b)(1), 
we proposed to redesignate the standard currently in Sec.  
438.6(c)(1)(i)(A) that capitation rates have been developed in 
accordance with generally accepted actuarial principles and practices. 
We also proposed in Sec.  438.4(b)(1) that capitation rates must meet 
the standards described in proposed Sec.  438.5 dedicated to rate 
development standards. We acknowledged that states may desire to 
establish minimum provider payment rates in the contract with the 
managed care plan. Because actuarially sound capitation rates must be 
based on the reasonable, appropriate, and attainable costs under the 
contract, minimum provider payment expectations included in the 
contract would necessarily be built into the relevant service 
components of the rate. However, we proposed in paragraph (b)(1) to 
prohibit different capitation rates based on the FFP associated with a 
particular population. We explained at 80 FR 31120 that different 
capitation rates based on the FFP associated with a particular 
population represented cost-shifting from the state to the federal 
government and were not based on generally accepted actuarial 
principles and practices.
    We received the following comments on the introductory language in 
Sec.  438.4(b) and paragraph (b)(1).
    Comment: One commenter suggested that Sec.  438.4(b) should be 
revised to delete ``do all of the following:'' so that paragraphs 
(b)(1) through (b)(8) read properly as complete sentences.
    Response: We appreciate the commenter's technical suggestion and 
have deleted that phrase from paragraph (b) for that reason. We note 
that each provision in paragraphs (b)(1) through (b)(8) must be met in 
order for CMS to approve capitation rates for MCOs, PIHPs, and PAHPs.
    Comment: Several commenters requested clarification that capitation 
rates, with different FFP, may still vary by projected risk, and 
associated cost differences. Commenters requested clarification that 
capitation rates may likely vary by population for numerous reasons, 
but agreed that FFP is not a permissible justification. Other 
commenters stated that the regulatory text did not take into account 
the fact that states receive 100 percent FFP for services and pay a 
special rate for services rendered to Indians by an Indian Health Care 
Provider.
    Response: We agree that additional guidance and clarification is 
appropriate for Sec.  438.4(b)(1). The practice intended to be 
prohibited in paragraph (b)(1) was variance in capitation rates per 
rate cell that was due to the different rates of FFP associated with 
the covered populations. For example, we have seen rate certifications 
that set minimum provider payment requirements or establish risk 
margins for the managed care plans only for covered populations 
eligible for higher percentages of FFP. Such practices, when not 
supported by the application of valid rate development standards, are 
not permissible under this rule. The provision would not prohibit the 
state from having different capitation rates per rate cell based on the 
projected risk of populations under the contract or based on different 
payment rates to providers that are required by federal law (for 
example, section 1932(h) of the Act). We will finalize Sec.  
438.4(b)(1) to provide that any differences among capitation rates 
according to covered populations must be based on valid rate 
development standards and not be based on the FFP associated with the 
covered populations.
    After consideration of the public comments, we are finalizing the 
introductory text of Sec.  438.4(b) without the phrase ``do all the 
following'' and are finalizing Sec.  438.4(b)(1) with additional text 
to provide that any proposed differences among capitation rates must be 
based on valid rating factors and not on network provider reimbursement 
requirements that apply only to covered populations eligible for higher 
percentages of FFP.
    In Sec.  438.4(b)(2), we proposed to redesignate the provision 
currently at Sec.  438.6(c)(1)(i)(B). We restated the standard, but the 
substance is the same: the capitation rates must be appropriate for the 
population(s) to be covered and the services provided under the managed 
care contract.
    We received the following comments on Sec.  438.4(b)(2).
    Comment: Many commenters supported Sec.  438.4(b)(2) but some were 
concerned that the standard would not account for non-clinical services 
rendered under the contract or patient complexity and socio-demographic 
considerations. Others wanted assurance that the capitation rates

[[Page 27567]]

would account for the value of new and innovative therapies.
    Response: The requirement in Sec.  438.4(b)(2) is that the 
capitation rates are appropriate for the populations covered and 
services rendered under the contract. Because capitation rates are 
based on state plan services, and developed and certified at the rate 
cell level, and that unit of measure groups populations according to 
similar characteristics, this broad requirement would accommodate non-
clinical services received by enrollees under MLTSS programs, enrollees 
with chronic conditions, or other enrollees that receive non-clinical 
services. Medical management, assessment, and other coordination 
activities required under the contract would be reflected in audited 
financial reports, which is a required source of base data in Sec.  
438.5(c)(1). If new therapies are covered under the state plan, and 
therefore, the contract, those costs would be taken into account in the 
rate development process. Patient complexity based on sociodemographic 
considerations may be addressed as part of the risk adjustment 
methodology.
    After consideration of the public comments, we are finalizing Sec.  
438.4(b)(2) as proposed.
    In Sec.  438.4(b)(3), we proposed that capitation rates be adequate 
to meet the requirements on MCOs, PIHPs, and PAHPs in Sec. Sec.  
438.206, 438.207, and 438.208, which contain the requirements for MCOs, 
PIHPs, and PAHPs to ensure availability and timely access to services, 
adequate networks, and coordination and continuity of care, 
respectively. We noted that the definition of actuarially sound 
capitation rates in proposed Sec.  438.4(a) provides that the rates 
must provide for all reasonable, appropriate, and attainable costs that 
are required under the contract. The maintenance of an adequate network 
that provides timely access to services and ensures coordination and 
continuity of care is an obligation on the managed care plans for 
ensuring access to services under the contract. In the event concerns 
in these areas arise, the review of the rate certification would 
explore whether the capitation payments, and the provider rates on 
which the capitation payments are based, are sufficient to support the 
MCO's, PIHP's, or PAHP's obligations.
    We received the following comments on Sec.  438.4(b)(3).
    Comment: Many commenters supported Sec.  438.4(b)(3) and requested 
that states be required to demonstrate that the capitation rates 
support provider payment levels that reflect a living wage. Other 
commenters requested that CMS require states, on a periodic basis, to 
study and report on how capitation rates and the subsequent managed 
care plan reimbursement to providers affect patient access and provider 
network development. Some commenters stated that the evaluation of 
access should not be based on capitation rates alone. Other commenters 
recommended that CMS review the provider reimbursement levels of the 
managed care plans in its review and approval of the rate 
certifications.
    Other commenters were opposed to proposed Sec.  438.4(b)(3) and 
stated that the actuary should not be responsible for evaluating 
network adequacy. Commenters provided that it is the state's 
responsibility to assess and ensure managed care plan compliance with 
Sec. Sec.  438.206, 438.207, and 438.208 and that the actuary should be 
able to rely on the state's assessment. Several commenters requested 
additional guidance as to how this assessment would be conducted.
    Response: We maintain that the development of actuarially sound 
capitation rates includes an evaluation as to whether the capitation 
rates are adequate to meet the requirements on MCOs, PIHPs, and PAHPs 
in Sec. Sec.  438.206, 438.207, and 438.208, as those are obligations 
specified under the managed care contract. The underlying base data, 
cost and utilization assumptions, as well as the consideration of the 
MCO's, PIHP's, or PAHP's MLR experience, inform the evaluation as to 
whether the capitation rates are sufficient to maintain provider 
networks that ensure the availability of services and support 
coordination and continuity of care.
    In response to commenters that requested an additional evaluation 
of network adequacy or that suggested that review of capitation rates 
alone was not a sufficient evaluation of network adequacy, there are 
several other requirements regarding network adequacy that are in this 
part of note. Specifically, Sec.  438.207(d) requires the state to 
provide documentation to CMS, at specified times, that managed care 
plans meet the requirements in that section and Sec.  438.206, which 
incorporates compliance with the network adequacy standards established 
by the state under Sec.  438.68. In addition, the annual program report 
in Sec.  438.66 that is publicly available requires the state to report 
on the availability and accessibility of services in managed care plan 
networks. Finally, the mandatory EQR-related activity in Sec.  
438.358(b)(1)(iv) requires validation of MCO, PIHP, and PAHP network 
adequacy during the preceding 12 months for compliance with Sec.  
438.68.
    After consideration of the public comments, we are finalizing Sec.  
438.4(b)(3) as proposed.
    In Sec.  438.4(b)(4), we proposed that capitation rates be specific 
to the payment attributable to each rate cell under the contract. We 
explained that the rates must appropriately account for the expected 
benefit costs for enrollees in each rate cell, and for a reasonable 
amount of the non-benefit costs of the plan. We further explained that 
payments from any rate cell must not be expected to cross-subsidize or 
be cross-subsidized by payments for any other rate cell. In accordance 
with the existing rule in Sec.  438.6(c)(2)(i), we proposed that all 
payments under risk contracts be actuarially sound and that the rate 
for each rate cell be developed and assessed according to generally 
accepted actuarial principles and practices. See 67 FR 40989, 40998 
(discussion of existing rule). We proposed to make this a more explicit 
standard in the new regulation text in paragraph (b)(4) to eliminate 
any potential ambiguity and to be consistent with our goal to make the 
rate setting and rate approval process more transparent. Some states 
use rate ranges as a tool that allows the submission of one actuarial 
certification but permits further negotiation with each of the MCOs, 
PIHPs, and PAHPs within the rate range. We noted that, historically, we 
have considered any capitation rate paid to a managed care plan that 
was within the certified range to be actuarially sound regardless of 
where it fell in the range. Thus, states have not had to submit 
additional documentation to CMS as long as the final payment rate was 
within the certified rate range. Additionally, we noted that states 
have used rate ranges to increase or decrease rates paid to the managed 
care plans without providing further notification to CMS or the public 
of the change or certification that the change was based on actual 
experience incurred by the MCOs, PIHPs, or PAHPs that differed in a 
material way from the actuarial assumptions and methodologies initially 
used to develop the capitation rates. We proposed to alter past 
practices moving forward such that:
     Each individual rate paid to each MCO, PIHP, or PAHP be 
certified as actuarially sound with enough detail to understand the 
specific data, assumptions, and methodologies behind that rate.
     States may still use rate ranges to gauge an appropriate 
range of payments on which to base negotiations, but states would have 
to ultimately provide certification to CMS of a specific rate for each 
rate cell, rather than a rate range.

[[Page 27568]]

    We received the following comments in response to proposed Sec.  
438.4(b)(4).
    Comment: Some commenters were supportive of the prohibition of rate 
ranges in Sec.  438.4(b)(4) as an approach that would enhance the 
transparency and integrity of the rate setting process. Several 
commenters were opposed to the proposed elimination of rate ranges as 
it would reduce state flexibility to modify capitation rates during the 
course of the contract period and would result in an administratively 
burdensome rate setting process. Some commenters stated that the 
prohibition may result in the unintended consequence of diminishing a 
state's ability to implement capitation rate adjustments that support 
critical funding to providers that serve the Medicaid population or to 
implement programmatic changes and adjust capitation rates accordingly 
without the administrative burden associated with the submission a 
revised rate certification for CMS' review and approval. As an 
alternative, commenters suggested that CMS permit the certification of 
rate ranges within a specified range, such as plus or minus 3 to 5 
percent from the midpoint. If CMS adopted this provision as proposed, 
some commenters requested that the requirement be phased in over 3 to 5 
years.
    Response: We agree with commenters who supported restrictions in 
the use of rate ranges as a way to further enhance the integrity and 
transparency of the rate setting process, and to align Medicaid policy 
more closely with actuarial practices used in setting rates for non-
Medicaid health plans. We note that the current use of rate ranges is 
unique to Medicaid managed care. Other health insurance products that 
are subject to rate review (for example, QHPs or MA plans) submit and 
justify a specific premium rate. Although the use of both a specific 
rate and a rate range is mentioned in section 3.2.1 of the Actuarial 
Standards Board's ASOP 49, this ASOP was developed to reflect the 
current practice and regulations. Requirements under law or regulation 
take precedent over the ASOP.
    We believe that once a managed care plan has entered into a 
contract with the state, any increase in funding for the contract 
should correspond with something of value in exchange for the increased 
capitation payments. Our proposal also was based on the concern that 
some states have used rate ranges to increase capitation rates paid to 
managed care plans without changing any obligations within the contract 
or certifying that the increase was based on managed care plans' actual 
expenses during the contract period in a way that differed materially 
from the actuarial assumptions and methodologies initially used to 
develop the capitation rates. While we appreciate states' need for 
flexibility, we think there is an important balance to strike between 
administrative burden related to submitting revised rate certifications 
for small programmatic changes and upholding the principle that in the 
contracting process, managed care plans are agreeing to meet 
obligations under the contract for a fixed amount. Therefore, in this 
final rule, we will not permit states to certify to a rate range in the 
rate certification required in Sec.  438.7(a). We do, however, provide 
some administrative relief as described below with respect to small 
changes in the capitation rates.
    We recognize that the use of rate ranges can provide states greater 
flexibility to effectuate programmatic changes and adjust capitation 
rates accordingly without the administrative burden associated with a 
submission of a revised rate certification for our review and approval. 
In response to comments about the administrative burden associated with 
small programmatic changes, we will permit states flexibilities moving 
forward. First, states may increase or decrease the capitation rate 
certified per rate cell as required under Sec.  438.4(b)(4) by 1.5 
percent, which results in a 3 percent range, without submitting a 
revised rate certification for CMS review and approval based on our 
general determination that fluctuation of plus or minus 1.5 percent 
does not change the actuarial soundness of a capitation rate. We have 
selected 1.5 percent as the permissible modification because that 
percentage is generally not more than the risk margin incorporated into 
most states' rate development process. Some commenters suggested that 
there should be the flexibility to raise or lower capitation rates 3 to 
5 percent without a rate certification. We do not believe that 3 to 5 
percent (resulting in a 6 to 10 percent rate range) is a reasonable 
amount. At 5 percent, the top of the range is almost 11 percent more 
than the bottom of the range. It is difficult to imagine that both of 
these capitation rates are actuarially sound, especially when the risk 
margin is almost always less than 3 percent. Therefore, we are 
providing the flexibility to raise or lower the certified capitation 
rate without a revised rate certification, but at the smaller amount of 
one percent. If the state needs to make an adjustment to the capitation 
rate per rate cell that exceeds the 1.5 percent rate range, the state 
will need to submit a new rate certification supporting that change to 
CMS for review and approval. We believe that it is reasonable for the 
capitation rate to be modified a de minimis amount and still remain 
actuarially sound.
    The ability for the state to adjust the actuarially sound 
capitation rate during the rating period within a 1.5 percent range 
will be finalized at a new paragraph (c)(3) in Sec.  438.7, which 
governs the requirements for the rate certification. Because the 
initial rate certification, and any subsequent rate certification, must 
certify to a capitation rate per rate cell, the proposed regulatory 
text at Sec.  438.4(b)(4) will be finalized without modification. If a 
state modifies the capitation rate paid under the contract within that 
1.5 percent range from the capitation rate certified in the rate 
certification, the state will need to ensure that the payment rate in 
the contract is updated with CMS, as required in Sec.  438.3(c), to 
reflect the appropriate capitation rate for purposes of claiming FFP. 
We believe that it is reasonable for the capitation rate to be modified 
a de minimis amount and still remain actuarially sound. We remind 
commenters that application of a risk adjustment methodology that was 
approved in the rate certification (Sec.  438.7(b)(5) and the 
discussion of risk adjustment in section I.B.3.e) does not require a 
revised rate certification for our review and approval. However, the 
payment term in the contract will have to be updated for the same 
reasons as discussed when adjusting the capitation rates within the one 
percent rate range.
    We believe that this approach, which requires states to certify a 
specific rate but allows states to increase or decrease the capitation 
rate certified per rate cell by 1.5 percent, provides the most clarity 
on the particular assumptions, data, and methodologies used to set 
capitation rates, and facilitates CMS' review process of rate 
certifications in accordance with the requirements for actuarial sound 
capitation rates. The approach also provides states flexibility to make 
small changes while easing the administrative burden of rate review for 
both states and CMS. There are other mechanisms in the regulation for 
states to modify capitation rates when there is a more significant 
contract change or other valid rationale for an adjustment to the 
assumptions, data, or methodologies used to develop the capitation 
rates as specified in Sec. Sec.  438.5(f) and 438.7(b)(4). In addition, 
states have other options--such as setting minimum provider payment 
requirements for a class of providers at Sec.  438.6(c)(1)(iii)--to 
ensure access to

[[Page 27569]]

specified providers. As noted in the compliance date section at the 
beginning of this final rule, states must come into compliance with 
this requirement for contracts starting on or after July 1, 2018.
    Comment: A few commenters requested clarification on the 
requirement that payments from any rate cell must not cross-subsidize 
or be cross-subsidized by payments for any other rate cell under the 
contract. A commenter requested clarification if this requirement would 
prohibit blended rate structures. One commenter was concerned that this 
requirement would limit managed care plans from enhancing the delivery 
of community-based services.
    Response: The prohibition on cross-subsidization among rate cells 
under the contract is to ensure prudent fiscal management and that the 
capitation rate for each rate cell is independently actuarially sound. 
This provision does not require there to be different assumptions for 
each rate cell and does not prevent the use of the same assumptions 
across all rate cells (such as trend or age, gender or regional 
rating). This provision would not prohibit the use of blended rate 
structures. Blended rate structures are typically used for a rate cell 
covering individuals that have an institutional level of care and may 
receive institutional or home and community based services. To address 
comments specific to the delivery of community-based services, the 
development of an actuarially sound capitation rate for a rate cell 
that covers enrollees receiving LTSS under the contract must account 
for the home and community based services under the contract. We do not 
believe that the prohibition on cross-subsidization would inhibit the 
managed care plan's ability to provide home and community based 
services. The prohibition on cross-subsidization is tied to the FMAP 
associated with individuals covered under the contract and is not a 
barrier to incentivizing the delivery of home and community based 
services. However, for clarity, we believe that the two requirements 
proposed in Sec.  438.4(b)(4) should be stated separately in the final 
rule. Therefore, we will finalize the requirement that payments from 
any rate cell must not cross-subsidize or be cross-subsidized by 
payments for any other rate cell as a new paragraph Sec.  438.4(b)(5). 
All subsequent paragraphs in Sec.  438.4(b) will be renumbered 
accordingly.
    After consideration of public comments, we are finalizing Sec.  
438.4(b)(4) as proposed but will finalize Sec.  438.7(c) with an 
additional paragraph (3) to indicate that states may adjust the 
capitation rate within a 1.5 percent range without submitting a revised 
rate certification for CMS' review and approval. This provision also 
indicates that the payment term of the contract must be updated to 
reflect such adjustment of the capitation rate to be compliant with 
Sec.  438.3(c). The requirement that payments from any rate cell must 
not cross-subsidize or by cross-subsidized by payments for any other 
rate cell will be finalized as Sec.  438.4(b)(5).
    In proposed Sec.  438.4(b)(5), we proposed to redesignate the 
standard in current Sec.  438.6(c)(1)(i)(C) that an actuary certify 
that the rate methodology and the final capitation rates are consistent 
with the standards of this part and generally applicable standards of 
actuarial practice. We provided that this would require that all 
components and adjustments of the rate be certified by the actuary. We 
also restated that for this standard to be met, the individual 
providing the certification must be within our proposed definition of 
``actuary'' in Sec.  438.2. Proposed Sec.  438.4(b)(5) also 
incorporated the requirements at Sec.  438.3(c) and (e) to reiterate 
that the development of actuarially sound capitation rates is based on 
services covered under the state plan and additional services for 
compliance with parity standards (Sec.  438.3(c)) and is not based on 
additional services that the managed care plan voluntarily provides 
(Sec.  438.3(e)(1)).
    We received the following comments in response to proposed Sec.  
438.4(b)(5).
    Comment: We received one comment requesting that CMS clarify that 
the state's actuary is not certifying the assumptions underlying the 
rates. Otherwise, this requirement violates ASOP 49 which specifies 
``the actuary is not certifying that the underlying assumptions 
supporting the certification are appropriate for an individual MCO.''
    Response: The requirement in Sec.  438.4(b)(5) is consistent with 
section 3.1 of ASOP No. 49. An actuary may still certify capitation 
rates that differ by managed care plan, in which case we would assume 
that the actuary is certifying the capitation rate per rate cell for 
each managed care plan. An actuary may still need to consider 
differences among managed care plans when certifying capitation rates 
and to determine if one set of capitation rates is appropriate for 
multiple managed care plans within the state. For example, if a state 
has two managed care plans and one managed care plan costs twice as 
much of the other (for any number of reasons), we would be concerned 
about the actuarial soundness of those capitation rates if the actuary 
certified the capitation rates for the lowest cost managed care plan or 
the average of the two managed care plans.
    Comment: One commenter noted that the definition of actuary in 
Sec.  438.2 suggests that the actuary certifying to the capitation 
rates in the rate certification submitted to CMS for review and 
approval is the actuary acting on behalf of the state rather than the 
managed care plan.
    Response: The commenter is correct that the rate certification must 
be provided by an actuary who is working on behalf of the state. We 
will not accept a rate certification certified by a managed care plan's 
actuary.
    Comment: One commenter stated that the requirement that the final 
capitation rates be certified by an actuary is unnecessarily 
restrictive.
    Response: We disagree. Actuarially sound capitation rates are 
statutory condition for FFP at section 1903(m)(2)(A)(iii) of the Act. 
The process for developing the capitation rates must be certified by an 
actuary to ensure the integrity of the rate setting process. This is a 
longstanding requirement of the statute and regulations governing 
managed care plans under 42 CFR part 438 and we do not believe it is 
wise to eliminate it.
    Comment: One commenter questioned if it was appropriate for the 
actuary preparing the rate certification to assume that the CMS 
reviewer is another actuary.
    Response: Yes, the requirements in the rate certification in Sec.  
438.7 require a level of detail and documentation so that another 
actuary can understand and evaluate the application of the rate 
standards in accordance with generally accepted actuarial principles 
and practices. Federal review of Medicaid managed care capitation rates 
will be conducted by actuaries.
    After consideration of the public comments, we are finalizing Sec.  
438.4(b)(5) as proposed with the following technical modifications: (1) 
to redesignate this provision as Sec.  438.4(b)(6); and (2) to refine 
the reference to Sec.  438.3(c) to Sec.  438.3(c)(1)(ii) (pertaining to 
the types of services that the final capitation rates must be based 
upon) as the other requirements in Sec.  438.3(c) are not subject to 
the actuary's certification.
    As proposed, Sec.  438.4(b)(6) incorporated the special contract 
provisions related to payment proposed in Sec.  438.6 if such 
provisions were applied under the contract. In Sec.  438.6, we proposed 
to address requirements

[[Page 27570]]

for risk-sharing mechanisms, incentive arrangements, withhold 
arrangements, and delivery system and provider payment initiatives 
under MCO, PIHP, or PAHP contracts. Comments received on Sec.  438.6 
and considerations for rate setting are addressed in response to 
comments received on Sec.  438.6 generally.
    We received no comments on Sec.  438.4(b)(6) itself (that is, 
separate from comments about Sec.  438.6) and we will finalize Sec.  
438.4(b)(6) as proposed but will redesignate the provision as Sec.  
438.4(b)(7). We discuss Sec.  438.6 in section I.B.3.d.
    Section 438.4(b)(7) incorporated the documentation standards for 
the rate certification proposed in Sec.  438.7. We explained that for 
us to assess the actuarial soundness of capitation rates, the data, 
methodologies, and assumptions applied by the actuary must be 
sufficiently and transparently documented. We also explained that clear 
documentation would support the goal of instituting a meaningful and 
uniformly applied rate review and approval process and would streamline 
the process for both states and CMS.
    We received no comments on Sec.  438.4(b)(7) itself (that is, 
separate from comments about Sec.  438.7) and we will finalize Sec.  
438.4(b)(7) as proposed but will redesignate the provision as paragraph 
Sec.  438.4(b)(8). We discuss Sec.  438.7 in section I.B.3.e.
    In Sec.  438.4(b)(8), we proposed to include a new standard that 
actuarially sound capitation rates for MCOs, PIHPs, and PAHPs must be 
developed so that MCOs, PIHPs, and PAHPs can reasonably achieve a 
minimum MLR of at least 85 percent, and if higher, a MLR that provides 
for reasonable administrative costs when using the calculation defined 
in proposed Sec.  438.8. We explained that states could establish 
standards that use or require a higher MLR target--for rate development 
purposes, as a minimum MLR requirement for managed care plans to meet, 
or both--but that the MLR must be calculated in accordance with Sec.  
438.8. We noted that this minimum 85 percent standard, which is 
consistent with MLR standards for both private large group plans and MA 
organizations, balances the goal of ensuring enrollees are provided 
appropriate services while also ensuring a cost effective delivery 
system. As a result of this standard, the MLR reports from MCOs, PIHPs, 
and PAHPs would be integral sources of data for rate setting. For 
instance, states that discover, through the MLR reporting under 
proposed Sec.  438.8(k), that an MCO, PIHP, or PAHP has not met an MLR 
standard of at least 85 percent would need to take this into account 
and include adjustments in future year rate development. All such 
adjustments would need to comply with all standards for adjustments in 
Sec.  438.5(f) and Sec.  438.7(b)(4).
    We received the following comments in response to our proposal at 
Sec.  438.4(b)(8).
    Comment: Several commenters were supportive of 85 percent as the 
MLR standard for rate setting purposes while others provided that 
states should be able to set their own MLR threshold. Other commenters 
requested that CMS establish an upper limit on the MLR.
    Response: In the interest of establishing a national floor for 
Medicaid managed care plan MLRs, we will not permit states to establish 
an MLR that is less than 85 percent. We decline to establish an upper 
limit on the MLR that may be imposed by the state as appropriate higher 
MLR standards may depend on the particular managed care program. 
Therefore, we will finalize the language in Sec.  438.4(b)(8) 
specifying that an MLR threshold higher than 85 percent must result in 
capitation rates that are adequate for reasonable, appropriate, and 
attainable administrative costs in accordance with Sec.  438.5(e) (a 
conforming change, discussed in the comments and responses to Sec.  
438.5(e), is made to the regulatory text of Sec.  438.5(e) for 
consistency with the definition of actuarially sound capitation rates 
under Sec.  438.4(a)). For consistency with the language used in Sec.  
438.5(e), we will strike ``necessary'' and insert ``adequate,'' and 
replace ``administrative costs'' with ``non-claim costs'' so that the 
phrase reads ``capitation rates are adequate for reasonable, 
appropriate, and attainable non-claim costs'' in the final rule at 
Sec.  438.4(b)(8).
    Comment: One commenter requested that we clarify that the actuary 
should be able to take into consideration the MLR for all managed care 
plans' experience in a geographic rating area.
    Response: Recognizing that many states do not set capitation rates 
on an individual managed care plan level, it is permissible for the 
actuary to consider the MLR experience of managed care plans in the 
same rating area in the aggregate when developing the capitation rates 
for all such managed care plans.
    Comment: A commenter noted that since the first reporting year 
would coincide with the first contract year subject to the provisions 
of the final rule, past MLR experience data would not be available to 
apply the requirement in Sec.  438.4(b)(8).
    Response: Section 438.4(b)(8) requires that capitation rates be 
developed in a way that the MCO, PIHP or PAHP would reasonably achieve 
a MLR, as calculated under Sec.  438.8, of at least 85 percent for the 
rate year. The actual MLR experience is not required to create this 
projection for the first year. However, once the MLR reports are 
received by the state from the managed care plans--see Sec.  
438.8(k)(2)--Sec.  438.74(a) requires the state to submit a summary 
description of the reports with the rate certification. The reported 
MLR experience, once available, would inform the projection required in 
Sec.  438.4(b)(8) for later rating periods.
    Comment: A commenter requested clarification that capitation rates 
must be actuarially sound if the state establishes an MLR threshold 
above 85 percent.
    Response: We clarify that capitation rates that are subject to an 
MLR threshold above 85 percent must meet the requirements for 
actuarially sound capitation rates established in this part.
    Comment: One commenter requested we clarify that the consideration 
of the MLR in the rate setting process should not create a requirement 
to raise or lower capitation rates.
    Response: We disagree with the commenter. The consideration of a 
projected MLR--based on the assumptions underlying the rate setting 
process--may result in increases or decreases to the capitation rate to 
reach a projected MLR of at least 85 percent. The consideration of the 
actual MLR experience of the contracted managed care plans may 
necessitate a modification to capitation rates for future rating 
periods. To suggest otherwise in regulation would diminish the utility 
of requiring managed care plans to calculate and report an MLR and 
require states to take that experience into account in the rate setting 
process.
    After consideration of the public comments, we are finalizing Sec.  
438.4(b)(8) with a modification to use the standard ``appropriate and 
reasonable'' to modify ``non-benefit costs'', which was inserted in 
place of ``administrative costs'', for consistency with Sec.  438.5(e). 
We will also redesignate this provision as paragraph Sec.  438.4(b)(9).
c. Rate Development Standards (Sec.  438.5)
    We proposed Sec.  438.5 as a list of required steps and standards 
for the development of actuarially sound capitation rates. We discuss 
each paragraph of Sec.  438.5 below in more detail; we received the 
following comments on proposed Sec.  438.5 generally.

[[Page 27571]]

    Comment: We received many comments of support for the proposed 
provisions in Sec.  438.5. Commenters believed that the proposed 
provisions added much needed specificity to the processes and 
procedures that will bring consistency, accountability, and 
transparency to rate setting. A few commenters stated that proposed 
Sec.  438.5 was too prescriptive and could restrict the normal 
actuarial functions and payment innovation. One commenter believed that 
CMS should align its rate development standards with NAIC.
    Response: We appreciate commenters support for the rate development 
standards in proposed Sec.  438.5. We disagree that the standards set 
forth are too prescriptive as the standards are derived from generally 
accepted actuarial principles and practices, support payment innovation 
(for example, Sec.  438.6(c)(1)), and provide clarity as to our 
expectations for the development and documentation (as specified in 
Sec.  438.7) of actuarially sound capitation rates. We decline to align 
with rate development standards published by the NAIC as we maintain 
that there are unique considerations for the development of capitation 
rates in the Medicaid program and that it is appropriate for us to set 
forth Medicaid-specific standards for the development of actuarially 
sound capitation rates that are eligible for FFP.
    Comment: Several commenters requested that the regulatory text 
throughout Sec. Sec.  438.5 and 438.7 use ``appropriate'' rather than 
``sufficient'' or ``adequate'' out of concern that the latter two terms 
were too subjective.
    Response: We disagree with commenters that the terms ``sufficient'' 
or ``adequate'' are too subjective and that the term ``appropriate'' 
should be used in their place. According to the Merriam-Webster 
dictionary (accessed online), the simple definition of ``adequate'' is 
sufficient for a specific requirement or of a quality that is good or 
acceptable. At the same source, the word ``appropriate'' is defined as 
especially suitable or compatible or fitting, which implies association 
to a particular situation. Due to these distinctions, we maintain that 
the use of ``appropriate'' in Sec.  438.5 related to rate standards is 
accurate as it describes the rate development standards for a 
particular Medicaid program. However, Sec.  438.7 describes the level 
of documentation in the rate certification to support the rate 
development standards which is not associated with the characteristics 
of a particular Medicaid program. For that reason, Sec.  438.7 will be 
finalized with use of the adverb ``adequately'' in place of 
``sufficient'' so that the phrase reads adequately described with 
enough detail.
    In Sec.  438.5(a), we proposed to establish definitions for certain 
terms used in the standards for rate development and documentation in 
the rate certification in Sec.  438.7(b). We proposed to add 
definitions for ``budget neutral,'' ``prospective risk adjustment,'' 
``retroactive risk adjustment,'' and ``risk adjustment.''
    We proposed to define ``budget neutral'' in accordance with the 
generally accepted usage of the term as applied to risk sharing 
mechanisms, as meaning no aggregate gain or loss across the total 
payments made to all managed care plans under contract with the state.
    We received the following comments on the proposed definition for 
``budget neutral.''
    Comment: We received a couple of comments on the definition of 
``budget neutral'' in Sec.  438.5(a). The commenter believed that to be 
consistent with the prospective nature of the rate development process, 
CMS should include `` . . . and does not create an expected net 
aggregate gain or loss across all payments'' to the definition for 
``budget neutral.''
    Response: The ``budget neutral'' requirement in Sec.  438.5(g) and 
as defined at Sec.  438.5(a) only applies to the application of risk 
adjustment. The distinction between prospective and retrospective risk 
adjustment is based on the data source used to develop the risk 
adjustment model. The application of the risk adjustment methodology 
cannot result in a net aggregate gain or loss across all payments. If a 
state uses prospective risk adjustment--that is, they are applying risk 
adjustment to the capitation rates initially paid and do not reconcile 
based on actual enrollment or experience--the application of the risk 
adjustment methodology is expected, but not certain, to be budget 
neutral and is consistent with the regulatory requirement. We would not 
require a state conduct a reconciliation under a prospective risk 
adjustment approach.
    However, we do believe that additional clarification to the 
definition for ``budget neutral'' is warranted in respect to the 
payments for which there can be no net aggregate gain or loss. The 
payments are the capitation payments subject to risk adjustment made to 
all managed care plans under contract for the particular managed care 
program. This clarification to reference ``managed care program'' in 
the regulatory text is to recognize that states may have more than one 
Medicaid managed care program--for example physical health and behavior 
health--and a risk adjustment applied to behavioral health contracts 
would not impact the physical health program.
    After consideration of public comments, we are finalizing the 
definition of ``budget neutral'' with modifications to clarify the 
payments considered when determining that no net gain or loss results 
from the application of the risk adjustment methodology.
    We proposed to define ``risk adjustment'' as a methodology to 
account for health status of enrollees covered under the managed care 
contract. We proposed that the definitions for ``prospective risk 
adjustment'' and ``retrospective risk adjustment'' clarify when the 
risk adjustment methodology is applied to the capitation rates under 
the contract.
    We received the following comment on the proposed definition for 
``risk adjustment.''
    Comment: We received one comment on the proposed definition for 
``risk adjustment'' at Sec.  438.5(a). The commenter suggested that for 
consistency with ASOP No. 49, the definition of ``risk adjustment'' 
should be revised to clarify that the health status of enrollees is 
determined via relative risk factors.
    Response: We agree with the commenter about the appropriate 
definition for ``risk adjustment'' and will finalize the definition for 
``risk adjustment'' in Sec.  438.5(a) with a reference to relative risk 
factors.
    After consideration of public comments, we are finalizing the 
definition of ``risk adjustment'' with additional text that specifies 
that risk adjustment determines the health status of enrollees via 
relative risk factors. In addition, we will finalize Sec.  438.5(a) 
with a technical edit to the introductory text at Sec.  438.5(a) to 
specify that the defined terms apply to Sec.  438.5 and Sec.  438.7(b).
    We did not receive comments on proposed definitions for 
``prospective risk adjustment'' or ``retrospective risk adjustment'' 
and will finalize those definitions without modification.
    In Sec.  438.5(b), we set forth the steps a state, acting through 
its actuary, would have to follow when establishing Medicaid managed 
care capitation rates. The proposed standards were based on furthering 
the goals of transparency, fiscal stewardship, and beneficiary access 
to care. We explained that setting clear standards and expectations for 
rate development would support managed care systems that can operate 
efficiently, effectively, and with a high degree of fiscal integrity.

[[Page 27572]]

    We based these steps on our understanding of how actuaries approach 
rate setting with modifications to accommodate what actuarial soundness 
should include in the context of Medicaid managed care. We solicited 
comment on whether additional or alternative steps were more 
appropriate to meet the stated goals for establishing standards for 
rate setting. While we do not require for these steps to be followed in 
the order listed in this final rule, we proposed that the rate setting 
process include each step and follow the standards for each step. 
States would have to explain why any one of the steps was not followed 
or was not applicable. The six steps included:
     Collect or develop appropriate base data from historical 
experience;
     Develop and apply appropriate and reasonable trends to 
project benefit costs in the rating period, including trends in 
utilization and prices of benefits;
     Develop appropriate and reasonable projected costs for 
non-benefit costs in the rating period as part of the capitation rate;
     Make appropriate and reasonable adjustments to the 
historical data, projected trends, or other rate components as 
necessary to establish actuarially sound rates;
     Consider historical and projected MLR of the MCO, PIHP, or 
PAHP; and
     For programs that use a risk adjustment process, select an 
appropriate risk adjustment methodology, apply it in a budget neutral 
manner, and calculate adjustments to plan payments as necessary.
    We discuss each step within Sec.  438.5(b) below and received the 
following comments on proposed Sec.  438.5(b) generally.
    Comment: We received one comment on the order of the steps proposed 
in Sec.  438.5(b). The commenter believed that the order in which they 
are presented may not align with all the variations that exist today. 
For example, Step 4 (adjustments for benefit, program and other 
changes) may be performed before trend. The commenter requested that 
CMS clarify in the regulation text if CMS anticipates requiring a 
specific order of adjustments or if states and actuaries will have 
flexibility with the capitation rate setting order of adjustments.
    Response: At 80 FR 31121 and as restated above, we do not intend 
for the steps in Sec.  438.5(b) to be followed in the order as 
presented in the regulation; however, the state would need to apply 
each step or explain why a particular step was not applicable. For 
clarity on that point, we will finalize introductory text at Sec.  
438.5(b) that acknowledges that the order of the steps in the 
regulation text is not required; specifically, we will finalize 
regulation text that requires the steps to be followed ``in an 
appropriate order.'' The actuary may use his or her judgment as to the 
order that is appropriate for the particular rate setting, but must 
complete each step or explain why the step is not applicable.
    After consideration of public comments, we are finalizing the 
introductory text in Sec.  438.5(b) with changes to clarify that the 
steps in paragraph (b) have to be performed in an appropriate order.
    We did not receive comments on proposed Sec.  438.5(b)(1), 
pertaining to the identification and development of the base 
utilization and price data as specified in paragraph (c) of this 
section, and will finalize without modification.
    We received the following comment on proposed Sec.  438.5(b)(2) 
that cross-referenced the requirements for trend in paragraph (d) of 
this section.
    Comment: We received one comment requesting clarification if 
proposed Sec.  438.5(b)(2) means that a state would have to develop 
separate trend for cost and utilization and then apply them to their 
respective components of the base rate.
    Response: We appreciate the commenter raising this point for 
clarification. The provision at Sec.  438.5(b)(2) would not require the 
development of separate trends for cost and utilization and it would be 
permissible for the actuary to apply a trend that captures both cost 
and utilization. Note that this is consistent with section 3.2.9 of 
ASOP No. 49, which provides that the actuary should include appropriate 
adjustments for trend and may consider a number of elements in 
establishing trends in utilization, unit costs, or in total.'' See 
http://www.actuarialstandardsboard.org/wp-content/uploads/2015/03/asop049_179.pdf. This provision acknowledges that the development of 
trend factors may encompass a number of considerations related to the 
actual experience of the Medicaid managed care program and that cost 
and utilization must be considered. Note that Sec.  438.7(b)(2) sets 
forth the documentation requirements for each trend.
    After consideration of public comments, we are finalizing Sec.  
438.5(b)(2) as proposed without modification.
    We received the following comments on proposed Sec.  438.5(b)(3) 
that cross-referenced the requirements for the non-benefit component of 
the capitation rate in paragraph (e) of this section.
    Comment: We received a few comments on the wording of proposed 
Sec.  438.5(b)(3). The commenters stated concern regarding the word 
``or'' since all of the components listed must be included in 
capitation rates. The commenter recommended changing ``. . . cost of 
capital; or other operational costs . . .'' to ``cost of capital; and 
other operational costs.''
    Response: We agree with the commenter and have also made a 
corresponding change to Sec.  438.5(e).
    Comment: One commenter believed that the term ``risk margin'' is a 
more appropriate term than ``profit margin'' in proposed Sec.  
438.5(b)(3). The commenter also requested clarification as to whether 
Sec.  438.5(b)(3) would require the state to include an explicit 
provision for each of the non-benefit items listed in the section or if 
it would be acceptable to combine several of the items into a single 
rating factor. For example, the provision for contribution to reserves, 
profit margin, and cost of capital could be included in risk margin.
    Response: We agree with the commenter's suggestion that ``risk 
margin'' is a more appropriate term than ``profit margin'' because 
profit could be a subset of the risk margin for the non-benefit 
component of the capitation rate. We will finalize Sec.  438.5(b)(3) 
using the term ``risk margin.'' To address the commenter's question 
about the level of documentation required for the development of the 
non-benefit component, Sec.  438.7(b)(3) provides that the development 
of the non-benefit component of the capitation rate must be adequately 
described with enough detail so that CMS or an actuary applying 
generally accepted actuarially principles and practices can identify 
each type of non-benefit expense and evaluate the reasonableness of the 
cost assumptions underlying each expense. Sections 438.5(b)(3) and (e) 
list the following types of non-benefit expenses: Administration; 
taxes, licensing and regulatory fees; contribution to reserves; risk 
margin; cost of capital; and other operational costs. While the 
documentation of the non-benefit component cannot combine all of these 
items into a single rating factor, it would be permissible for the 
actuary to document the non-benefit costs in groupings, for example: 
Administration; taxes, licensing and regulatory fees; contribution to 
reserves, risk margin, cost of capital, and other operational costs.
    After consideration of public comments, we are finalizing

[[Page 27573]]

Sec.  438.5(b)(3) with modifications. The revisions are: (1) To use 
``risk margin'' rather than ``profit margin''; and (2) to use ``and 
other operational costs'' to clarify that all listed categories of non-
benefit costs must be included in the development of actuarially sound 
capitation rates.
    We received the following comment on proposed Sec.  438.5(b)(4) 
that cross-referenced the requirements for adjustments in paragraph (f) 
of this section.
    Comment: We received a few comments on proposed Sec. Sec.  
438.5(b)(4) and 438.7(b)(4) (as the latter describes the documentation 
necessary for adjustments in the rate certification), requesting 
confirmation that all adjustments including, but not limited to, those 
in ASOP No. 49 and the CMS Rate Setting Checklist continue to be valid 
under the proposed rule as part of generally accepted actuarial 
principles and practices.
    Response: We maintain that the requirements for developing and 
documenting adjustments are consistent with the practice standards in 
ASOP No. 49. We restate that every component of the rate setting 
process is based on generally accepted actuarial principles and 
practices. As stated in other forums, the CMS Ratesetting Checklist is 
an internal tool for CMS' use when reviewing rate certifications. The 
applicability or need to update that tool based on changes in these 
regulations is outside the scope of this rule. States, their actuaries, 
and managed care plans should rely on the regulatory requirements 
related to rate setting in Sec. Sec.  438.4-438.7, and consistent with 
all other provisions in this part, when developing capitation rates and 
other formal rate development guidance published by CMS (for example, 
2016 Medicaid Managed Care Rate Development Guide available at https://www.medicaid.gov/medicaid-chip-program-information/by-topics/delivery-systems/managed-care/downloads/2016-medicaid-rate-guide.pdf).
    After consideration of public comments, we are finalizing Sec.  
438.5(b)(4) as proposed.
    We received the following comments on proposed Sec.  438.5(b)(5) 
that incorporated the requirement to take a managed care plan's past 
MLR into account.
    Comment: We received a few comments requesting clarification on how 
proposed Sec.  438.5(b)(5) can be met. Commenters stated that it is 
common practice to review the historical and emerging financial 
experience of both the individual managed care plan and for the program 
as a whole, but rarely, if ever, is a specific adjustment made in the 
capitation rate setting process to adjust for the MLR observed or 
emerging. Commenters provided that historical MLR data will not reflect 
more recent changes to programs and capitation rates that would bring 
expected experience in line with capitation rate development 
assumptions. One commenter believed that CMS will not need to consider 
historical MLR experience because of the use of the historical cost 
experience trended forward to develop revenue requirements and that 2 
years to correct any issues seems reasonable for corrections.
    Response: The requirement in Sec.  438.5(b)(5) is that the managed 
care plans' MLR experience is one of the many considerations taken into 
account in the development of actuarially sound capitation rates. An 
MLR below 85 percent, or that is substantially higher than expected, 
will likely be part of our review and we would expect the actuary to 
explain how the MLR experience was taken into account in the 
development of the capitation rates. In addition, there is specific 
information from the MLR reports, such as activities that improve 
health care quality, that could be important for future rate setting 
purposes and which would not be reflected in base data sources based on 
service delivery.
    Comment: One commenter noted that proposed Sec.  438.5(b)(5) 
referred to ``Sec.  438.4(b)(7)'' when the intended cite should be 
Sec.  438.4(b)(8).
    Response: We appreciate the commenter bringing this error to our 
attention. Section 438.4(b)(8) is the correct cross-reference and we 
will make that correction in the final rule.
    After consideration of public comments, we are finalizing Sec.  
438.5(b)(5) with a modification to correct the cross-reference to Sec.  
438.4(b)(9) for consistency with redesignation of paragraphs in Sec.  
438.4(b) discussed above.
    We received the following comments on proposed Sec.  438.5(b)(6) 
that cross-referenced the requirements for risk adjustment in paragraph 
(g) of this section.
    Comment: We received a few comments requesting that proposed Sec.  
438.5(b)(6) be revised to reflect that step 6 relating to risk 
adjustment is only applicable if the state is choosing to risk adjust 
the rates. The commenters believed this would make the provision more 
accurate since risk adjustment is not required.
    Response: We agree with the commenters' suggestion and have 
modified Sec.  438.5(b)(6) to clarify that this step is applicable if a 
risk adjustment methodology is applied.
    After consideration of public comments, we are finalizing Sec.  
438.5(b)(6) to limit application of the budget neutral requirement for 
risk adjustment to the managed care programs within a state to which 
risk adjustment is applied.
    In Sec.  438.5(c), we proposed standards for selection of 
appropriate base data. In paragraph (c)(1), we proposed that, for 
purposes of rate setting, states provide to the actuary Medicaid-
specific data such as validated encounter data, FFS data (if 
applicable), and audited financial reports for the 3 most recent years 
completed prior to the rating period under development. In Sec.  
438.5(c)(2), we proposed that the actuary exercise professional 
judgment to determine which data is appropriate after examination of 
all data sources provided by the state, setting a minimum parameter 
that such data be derived from the Medicaid population or derived from 
a similar population and adjusted as necessary to make the utilization 
and cost data comparable to the Medicaid population for which the rates 
are being developed. We proposed that the data that the actuary uses 
must be from the 3 most recent years that have been completed prior to 
the rating period for which rates are being developed. For example, for 
rate setting activities in 2016 for CY 2017, the data used must at 
least include data from calendar year 2013 and later. We noted that 
while claims may not be finalized for 2015, we would expect the actuary 
to make appropriate and reasonable judgments as to whether 2013 or 2014 
data, which would be complete, must account for a greater percentage of 
the base data set. We used a calendar year for ease of reference in the 
example, but a calendar year is interchangeable with the state's 
contracting cycle period (for example, state fiscal year). We also 
noted that there may be reasons why older data would be necessary to 
inform certain trends or historical experience containing data 
anomalies, but the primary source of utilization and price data should 
be no older than the most recently completed 3 years. Noting that 
states may not be able to meet the standard in proposed paragraph 
(c)(2) for reasons such as a need to transition into these new 
standards or for an unforeseen circumstance where data meeting the 
proposed standard is not available, we proposed an exception in the 
regulation to accommodate such circumstances. We proposed, in Sec.  
438.5(c)(3)(i) and (ii), that the state may request an exception to the

[[Page 27574]]

provision in paragraph (c)(2) that the basis of the data be no older 
than from the 3 most recent and complete years prior to the rating 
period provided that the state submits a description of why an 
exception is needed and a corrective action plan with the exception 
request that details how the problems will be resolved in no more than 
2 years after the rating period in which the deficiency was discovered, 
as proposed in Sec.  438.5(c)(3)(ii). We stated that 2 years was enough 
time for states to work with their contracted managed care plans or 
repair internal systems to correct any issues that impede the 
collection and analysis of recent data. We requested comment on this 
proposed standard and our assumption about the length of time to 
address data concerns that would prevent a state from complying with 
our proposed standard.
    We received the following comments in response to proposed Sec.  
438.5(c).
    Comment: We received many comments on the proposed provision Sec.  
438.5(c)(1) requiring the use of data from ``at least the last 3 most 
recent and complete years.'' Many commenters believed that generally 
accepted actuarial principles and practices typically would allow for 
use of only 1 to 2 years of data and that time periods greater than 
that may add prohibitive cost. Commenters recommended that, rather than 
the requirements we proposed, the base data should be determined via 
actuarial judgment, consistent with ASOP No. 49, in consultation with 
the state. We received one comment recommending that CMS limit the base 
data for developing the managed care plans' capitation rates to the 
most recent and complete 3 years prior to the rating period as older 
data may incorporate assumptions and experience that are no longer 
applicable.
    Response: The requirement in Sec.  438.5(c)(1) is that the state 
provide the actuary with the listed sources of base data for at least 
the 3 most recent and complete years prior to the rating period. As 
discussed at 80 FR 31121, we provided that the actuary would exercise 
professional judgment to determine which data is appropriate after 
examination of all data sources provided by the state. At Sec.  
438.5(c)(2), the actuary must use the most appropriate base data from 
that provided by the state and the basis of the data must be no older 
than from the 3 most recent and complete rating periods. The actuary 
would not be required to use base data from the rating period 3 years 
prior to the rating period for which capitation rates are being 
developed; however, base data from that rating period may be necessary 
to inform certain trends or historical experience containing data 
anomalies.
    Comment: We received many comments on the proposed provision in 
Sec.  438.5(c)(1) requiring the use of audited financial reports. 
Commenters recommended that the base data requirements in Sec.  
438.5(c) be expanded to include unaudited managed care plan experience 
reports. Some commenters stated that there should be options for using 
alternative CEO/CFO certified reports, or utilization of reports done 
on a statutory accounting basis because requiring GAAP audited 
financial reports will increase costs for managed care plans, which 
will result in higher costs for states and CMS, but may have only 
limited additional value. Commenters stated that states would be unable 
to take advantage of unaudited, but more recent, restated financial 
data typically collected by states 3 months after the close of each 
calendar year and that using the most recent data increases the 
relevance and reliability of assumptions underlying final payment 
rates.
    Response: We maintain that audited financial reports are an 
important source of base data for the purposes of rate setting and this 
final rule includes the annual submission of audited financial reports 
as a standard contract provision at Sec.  438.3(m). The requirement at 
Sec.  438.5(c)(1) would not prohibit the actuary from also relying on 
more recent unaudited financial reports if such information is useful 
in the rate setting process, but such data does not supplant the 
inclusion of audited financial reports. We view Sec.  438.5(c)(1) as 
setting the minimum scope of base data that must be provided to the 
state's actuaries engaged in rate setting; it does not prohibit the 
provision or use of additional data (subject to paragraphs (c)(2) and 
(c)(3)).
    Comment: We received a few comments on the use of FFS data as 
proposed in Sec.  438.5(c)(1). Commenters believed that CMS should 
modify this section to not only allow that base data may vary from the 
traditional FFS type model, but that promotes the use of alternative 
payment methods which may not fall into the proposed base data 
requirements. Another commenter stated that as managed care grows, FFS 
data becomes less available and less reliable as a benchmark for 
establishing capitation rates and may not truly reflect the health 
status of, and spending for, individuals in managed care plans.
    Other commenters requested that CMS require states to consider 
market rates in MA, CHIP, and the private market when developing the 
capitation rates.
    Response: We agree that FFS may not be the most reliable or 
relevant source of base data, especially for mature managed care 
programs. Note that at Sec.  438.5(c)(1) modifies FFS data with ``as 
appropriate'' to recognize that such data may not be a reasonable data 
source in all circumstances; however, such data would likely be 
relevant when a new population transitions to a managed care program. 
We believe that encounter data and audited financial reports would be 
appropriate sources of base data under managed care contracts that use 
value-based purchasing.
    Regarding the commenters that requested that CMS require states to 
consider market rates in other coverage options when developing 
capitation rates, it would not be appropriate for us to do so. The 
relevant base data must be based on the Medicaid population, or if such 
data is not available, the base data must be derived from a similar 
population and adjusted to make the utilization and price data 
comparable to data from the Medicaid population.
    Comment: We received many comments on the exceptions process 
proposed in Sec.  438.5(c)(3). Several commenters believed that changes 
should be made to proposed Sec.  438.5(c)(2) (as discussed above) to 
prevent states from needing exceptions. One commenter requested that 
the exception and explanation be contained within the actuarial 
certification documentation if the actuary is the originator of the 
exception request. The commenter stated that it will often be the 
opinion and request of the actuary to modify the base data used in the 
capitation rate development process. We received one comment 
recommending that proposed Sec.  438.5(c)(3) be eliminated and that no 
exceptions be permitted.
    Response: We maintain that it is appropriate to permit an 
exceptions process to the base data requirement. The request for an 
exception with a supporting explanation may be contained within the 
rate certification if the actuary is the originator of the exception 
request.
    Comment: We received several comments on proposed Sec.  
438.5(c)(3)(ii) stating that 2 years is not sufficient time for 
corrective action. One commenter believed that 2 years is generally 
insufficient for new populations and that the requirement should be 
revised to a 3-year term with an opportunity for extensions on a case-
by-case basis. One commenter recommended that more detail be added to 
Sec.  438.5(c)(3)(ii) to reflect the review, approval, and

[[Page 27575]]

monitoring processes for the corrective action plans.
    Response: We disagree that a 2 year corrective action plan is 
insufficient time to remedy base data issues. It is not clear why 
commenters suggested that compliance with the base data requirements 
for new populations would require more time. Section 438.5(c)(1) 
requires states to use validated encounter data, FFS data (as 
appropriate), and audited financial reports. Managed care plans are 
required to submit encounter data in accordance with Sec.  438.242 and 
FFP is conditioned on the state's submission of validated encounter 
data in Sec.  438.818. Audited financial reports must be submitted by 
the managed care plans on an annual basis per Sec.  438.3(m). The 
regulations would permit the state to rely on FFS data or data for 
similar populations that is adjusted to reflect the Medicaid population 
when new populations are added to a managed care program. We will 
consider providing additional detail on the review and approval of the 
exceptions process to the base data requirements in subregulatory 
guidance.
    After consideration of public comments, we are finalizing Sec.  
438.5(c) as proposed.
    Section 438.5(d) addressed standards for trend factors in setting 
rates. Specifically, we proposed that trend factors be reasonable and 
developed in accordance with generally accepted actuarial principles 
and practices. We also stipulated that trend factors be developed based 
on actual experience from the same or similar populations. We proposed 
specific standards for the documentation of trend factors in proposed 
Sec.  438.7(b)(2). We requested comment on whether we should establish 
additional parameters and standards in this area.
    Comment: We received a number of comments on proposed Sec.  
438.5(d). Most of the commenters recommended that CMS not limit or 
restrict the data and information sources used in trend development. 
The commenters acknowledged that actual experience from the Medicaid, 
or a similar population, should be the primary source of trend data and 
information, but that generally accepted actuarial practices and 
principles do not limit or restrict the data and information sources 
used in trend development. Prospective trends may, and often do, differ 
materially from historical experience trends, whether or not it is from 
the Medicaid population or a similar population. Commenters recommended 
that CMS include language in the final rule referencing other 
appropriate and relevant data, other information sources, and 
professional judgment to aid in the development of prospective trends 
to be consistent with current practices and principles. Another 
commenter suggested that some flexibility should be provided for trend 
when new, innovative payment models are being implemented. 
Additionally, if trend is always tied to actual experience, it provides 
an incentive over the long-run to use more services, or services at a 
higher cost to push trend higher.
    Response: The trend should be a projection of future costs for the 
covered population and services. It should be based on what the actuary 
expects for that covered population and historical experience is an 
important consideration. That said, we agree that it is not the only 
source the actuary may consider and there are instances when historical 
experience may not be relevant or the sole source for the development 
of trend. As proposed, Sec.  438.5(d) provided that trend must be 
developed from the Medicaid population or a similar population. We did 
not intend this requirement to prohibit the actuary from using national 
projections for other payer trends in addition to sources derived from 
the Medicaid population or similar populations.
    However, general trends unassociated with the Medicaid population 
or similar populations cannot be the sole or primary source of 
information to develop the trends. To clarify this distinction, address 
the comment, and to better reflect our intent that other sources of 
data may be used to set trend, we will finalize Sec.  438.5(d) with 
additional text. Trend must be developed primarily from actual 
experience of the Medicaid population or from a similar population. The 
trend should be a projection of future costs for the covered population 
and services. It should be based on what the actuary expects for that 
population, and historical experience is an important consideration. 
Actual experience must be one consideration for developing trend and 
the actuary must compare the experience to projected trends.
    After consideration of public comments, we are finalizing Sec.  
438.5(d) with modification to provide that trend must be developed 
primarily from actual experience of the Medicaid population or from a 
similar population.
    Paragraph (e) established standards for developing the non-benefit 
component of the capitation rate, which included expenses related to 
administration, taxes, licensing and regulatory fees, reserve 
contributions, profit margin, cost of capital, and other operational 
costs. We explained in preamble that the only non-benefit costs that 
may be recognized and used for this purpose are those associated with 
the MCO's, PIHP's, or PAHP's provision of state plan services to 
Medicaid enrollees; the proposed regulation text provided for the 
development of non-benefit costs ``consistent with Sec.  438.3(c),'' 
thus incorporating the authority to include costs related to 
administration of additional benefits necessary for compliance with 
mental health parity standards reflected in subpart K of part 438.
    We received the following comments on the non-benefit component 
rate standard proposed Sec.  438.5(e).
    Comment: Several commenters recommended that CMS consider revising 
the final rule regarding the non-benefit components of the rate to 
state that such rate component should be ``reasonable, appropriate, and 
attainable'' consistent with the definition of actuarially sound 
capitation rates.
    Response: We agree with commenters that the non-benefit expenses in 
Sec.  438.5(e) should be modified by ``reasonable, appropriate, and 
attainable'' rather than ``appropriate and reasonable'' for consistency 
with the definition of actuarially sound capitation rates in Sec.  
438.4(a). The definition of actuarially sound capitation rates explains 
that such capitation rates are a projection of all ``reasonable, 
appropriate, and attainable'' costs that are required under the terms 
of the contract and for the operation of the MCO, PIHP or PAHP for the 
time period and populations covered under the contract, and such costs 
are comprised of benefit and non-benefit components. Therefore, it is 
appropriate to use ``reasonable, appropriate, and attainable'' in Sec.  
438.5(e).
    Comment: Several commenters requested clarification that the non-
benefit component of the capitation rate is not required to be 
completed at the rate cell level; rather, it would be appropriate to 
develop these costs across the managed care program.
    Response: We clarify here that the development of the non-benefit 
component may be developed at the aggregate level and incorporated at 
the rate cell level.
    Comment: One commenter requested that CMS clarify if medical 
management could be included in the non-benefit component proposed in 
Sec.  438.5(e) while another requested if corporate overhead could be 
included. Another commenter recommended that there be consistency for 
accounting and the rate setting

[[Page 27576]]

process, and that ``non-benefit, health care related expenses'' be 
allowed separate from administration, taxes, licensing and regulatory 
fees to account for services for integrated mental health treatment 
plans (required under mental health parity), and activities that 
support health care quality and care coordination.
    Response: Each of the expenses highlighted by commenters would fall 
under the ``other operational costs'' category for the non-benefit 
component of the capitation rate.
    Comment: Several commenters requested that CMS clarify that the 
Health Insurance Provider Fee established by section 9010 of the 
Affordable Care Act would be included in this definition and to address 
the non-deductibility of that fee. Commenters recommended that the 
final rule specify that these components should be included in rates in 
a timely manner to when Medicaid managed care plans incur these costs.
    Response: The Health Insurance Providers Fee established by section 
9010 of the Affordable Care Act is a regulatory fee that should be 
accounted for in the non-benefit component of the capitation rate as 
provided at Sec.  438.5(e). Our previous guidance on the Health Insurer 
Fee issued in October 2014 acknowledged that the non-deductibility of 
the fee may be taken into account when developing the non-benefit 
component of the capitation rate. See http://www.medicaid.gov/Federal-Policy-Guidance/Downloads/FAQ-10-06-2014.pdf. That guidance also 
explained that the state could take the Health Insurer Providers Fee 
into account during the data or fee year. We decline to set forth 
explicit rules for the Health Insurance Providers Fee in this 
regulation as the existing guidance remains available.
    Comment: We received a few comments on proposed Sec.  438.5(e) in 
relation to MLR in Sec.  438.8. When Sec.  438.5(e) is viewed in 
conjunction with the MLR requirement, commenters stated that CMS' 
intent was not clear. The commenters believed that Sec.  438.5(e) was 
consistent with CMS' 2016 Rate Setting Guidance, which recommends 
developing PMPM cost estimates for many of these components. However, 
if the development of the non-benefit component of the capitation rate 
is based on reasonable, appropriate, and attainable expenses and the 
managed care plans have an MLR of less than 85 percent, commenters 
questioned whether the rate standards or the MLR standards would 
control. The commenters requested that CMS clarify the relationship 
between these requirements.
    Response: We interpret the commenters' concern to be that the 
requirement that the non-benefit component of the capitation rate is 
developed based on reasonable, appropriate, and attainable expenses 
consistent with Sec.  438.5(e) may still result in a managed care plan 
with an MLR experience of less than 85 percent. In other words, we 
believe that the commenter is asking whether the actuarial soundness of 
the capitation rate could be impacted or called into question if a 
managed care plan's MLR experience was less than 85 percent. In our 
view, actuarial soundness is a prospective process that anticipates the 
reasonable, appropriate, and attainable costs under the managed care 
contract for the rating period whereas MLR is a retrospective tool to 
assess whether capitation rates were appropriately set and to inform 
the rate setting process going forward. As provided in Sec.  
438.5(b)(5), the MLR experience of contracted managed care plans is one 
consideration among many in the development of actuarially sound 
capitation rates.
    After consideration of public comments, we are finalizing Sec.  
438.5(e) with a revision to require that non-benefit costs must be 
reasonable, appropriate, and attainable for consistency with the 
definition of actuarially sound capitation rates Sec.  438.4(a). As 
noted above, we are also finalizing Sec.  438.5(e) with three changes: 
(1) Using ``and other operational costs'' to clarify that all listed 
categories of non-benefit costs must be included in the development of 
actuarially sound capitation rates; (2) using ``risk margin'' instead 
of ``profit margin''; and (3) specifying that the non-benefit expenses 
must be associated with the provision of services identified in Sec.  
438.3(c)(1)(ii) to the populations covered under the contract in place 
of the cross-reference to Sec.  438.3(c) for increased clarity in the 
regulatory text.
    In paragraph (f), we proposed to address adjustments and explained 
that adjustments are important for rate development and may be applied 
at almost any point in the rate development process. We noted that most 
adjustments applied to Medicaid capitation rate development would 
reasonably support the development of accurate data sets for purposes 
of rate setting, address appropriate programmatic changes, the health 
status of the enrolled population, or reflect non-benefit costs. For 
additional discussion on acuity adjustments to account for the health 
status of the enrolled population, refer to the content on risk 
adjustment in section I.B.3.e of the proposed rule (80 FR 31126). We 
considered identifying specific adjustments we find permissible in the 
regulations instead of requiring additional justification, but we noted 
that such an approach might foreclose the use of reasonable 
adjustments.
    We received the following comment on proposed Sec.  438.5(f) 
relating to adjustments.
    Comment: The commenter believed that while acuity adjustments are 
invaluable for managed care plans, the acuity adjustments specified in 
this proposal would not allow for different types of adjustments. The 
commenter encouraged CMS to adopt flexibility in its definition of 
acuity adjustments to account for additional challenges, including risk 
exposure from the movement of complex populations to managed care, or 
the impact of high cost drug utilization.
    Response: The discussion of acuity adjustments in relation to risk 
adjustment was to clarify which approaches would fall under the 
respective rate development standards. Acuity adjustments fall under 
the categories of permissible adjustments specified in Sec.  438.5(f). 
In addition, we maintain that the standard in paragraph (f)--
adjustments developed in accordance with generally accepted actuarial 
principles and practices that address the development of an accurate 
base data set, address appropriate programmatic changes, and reflect 
the health status of the enrolled population--is sufficiently broad to 
permit the actuary to apply adjustments to address complex populations 
or the impact of high cost drug utilization in the development of 
actuarially sound capitation rates.
    After consideration of public comments, we are finalizing Sec.  
438.5(f) with a modification to insert the word ``reflect'' before 
``the health status of the enrolled population'' to improve clarity of 
the regulatory text.
    In paragraph (g), we proposed to set forth standards for risk 
adjustment. In general, risk adjustment is a methodology to account for 
the health status of enrollees when predicting or explaining costs of 
services covered under the contract for defined populations or for 
evaluating retrospectively the experience of MCOs, PIHPs, or PAHPs 
contracted with the state.
    We noted that states currently apply the concept of ``risk 
adjustment'' in multiple ways and for multiple purposes. In some cases, 
states may use risk adjustment as the process of

[[Page 27577]]

determining and adjusting for the differing risk between managed care 
plans. In other cases, states may use risk adjustment as the process of 
determining the relative risk of the total enrolled population compared 
to a standard population (for example, the enrolled population from a 
prior rating period). We noted that for purposes of this regulation, we 
consider the first case to be the concept of risk adjustment as 
described in Sec.  438.5(a) and Sec.  438.5(g). We consider the second 
case to be an acuity adjustment subject to the standards for 
adjustments in Sec.  438.5(f). Risk adjustment may be conducted in one 
of two ways. First, a state may use historical data to adjust future 
capitation payments. This is risk adjustment conducted on a prospective 
basis. Second, a state may perform a reconciliation and redistribution 
of funds based on the actual experience in the rating period. This is 
risk adjustment conducted on a retrospective basis. In Sec.  438.5(g), 
we proposed that risk adjustment, whether prospective or retrospective 
in nature, be budget neutral. This is a proposed redesignation and 
renaming of the standard that such mechanisms be cost neutral in the 
current Sec.  438.6(c)(1)(iii). The proposed documentation standards in 
the certification would depend on the type of risk adjustment chosen 
and were discussed in proposed Sec.  438.7(b)(4).
    We received the following comments in response to proposed Sec.  
438.5(g).
    Comment: Several commenters recommend that CMS require the 
development of risk adjustment methodologies that incorporate 
disparities and social determinants of health that contribute to 
patient complexity and disease severity. Commenters believed that 
providers that see a disproportionate share of complex/high cost 
patients are disadvantaged and undervalued when underlying, 
non[hyphen]clinical risk factors that impact patient outcomes are not 
captured.
    Response: Disparities and social determinants of health that 
contribute to patient complexity and disease severity would be 
appropriate considerations in developing the risk adjustment 
methodology. We maintain that the reference to generally accepted 
actuarial principles and practices in Sec.  438.5(g) is sufficient to 
address the application of such considerations in the risk adjustment 
methodology.
    After consideration of the public comments, we are finalizing Sec.  
438.5(g) as proposed.
d. Special Contract Provisions Related to Payment (Sec.  438.6)
    We proposed, at Sec.  438.6, contract standards related to payments 
to MCOs, PIHPs, and PAHPs, specifically, risk-sharing mechanisms, 
incentive arrangements, and withhold arrangements. This section built 
upon and proposed minor modifications to the special contract 
provisions that are currently codified at Sec.  438.6(c)(5). We 
proposed, at paragraph (a), three definitions applicable to this 
section. The definition for an ``incentive arrangement'' was unchanged 
from the definition that is currently at Sec.  438.6(c)(1)(iv).
    We proposed a definition for ``risk corridor'' with a slight 
modification from the existing definition at Sec.  438.6(c)(1)(v). The 
current definition specifies that the state and the contractor share in 
both profits and losses outside a predetermined threshold amount. 
Experience has shown that states employ risk corridors that may apply 
to only profits or losses. We therefore proposed to revise the 
definition to provide flexibility that reflects that practice.
    We also proposed to add a definition for ``withhold arrangements,'' 
which would be defined as a payment mechanism under which a portion of 
the capitation rate is paid after the MCO, PIHP, or PAHP meets targets 
specified in the contract.
    We received the following comments on proposals in Sec.  438.6(a).
    Comment: Several commenters were opposed to the proposed change in 
Sec.  438.6(a) to define risk corridors as having one-sided risk while 
others supported the proposed revision. Commenters stated that the 
rationale stated in the proposed rule at 80 FR 31114, which cited 
current state practice of one-sided risk corridors, did not 
substantiate the change. Commenters stated that the purpose of a risk 
corridor is to protect both the state and the managed care plan from 
excessive losses or profits resulting from the uncertainty of 
projecting payments and expenditures and that the proposed definition 
was inconsistent with the purpose of a risk corridor as well as with 
the application of risk corridors in the small and group markets. 
Commenters recommended that we retain the existing definition of a risk 
corridor that would account for upside and downside risk.
    Response: We agree with the commenters that a risk corridor should 
account for upside and downside risk and that our rationale for 
proposing the change to the definition was insufficient to justify a 
modification to how risk corridors should operate under Medicaid 
managed care programs. In the proposed definition, we referred to a 
``contractor'', which is not a defined term in this part, and will 
insert MCO, PIHP, and PAHP in its place. We will finalize the 
definition of a risk corridor in Sec.  438.6(a) as a risk sharing 
mechanism in which states and MCO, PIHPs, or PAHPs may share in profits 
and losses under the contract outside of a predetermined threshold 
amount.
    Comment: Several commenters requested clarification in the 
regulation that risk sharing arrangements are incentive arrangements 
and that incentive payments to FQHCs are to be held outside of the 
reconciliation process to reimburse FQHCs at the amounts required under 
the State plan.
    Response: The risk sharing arrangements, incentive arrangements, 
and withholds arrangements described in Sec.  438.6(a) and (b) are 
between the state and the MCO, PIHP or PAHP. These arrangements--and 
the requirements of Sec.  438.6(a) and (b)--do not regulate 
arrangements between the managed care plans and network providers. (See 
Sec.  438.3(i) for the regulation governing physician incentive plans, 
which are a type of incentive arrangement between managed care plans 
and providers). To directly address the commenters' request, FQHCs and 
RHCs are required by statute to be reimbursed according to 
methodologies approved under the State plan. In the event a particular 
financial incentive arrangement related to meeting specified 
performance metrics for these providers is part of the provider 
agreement with the managed care plan, those financial incentives must 
be in addition to the required reimbursement levels specified in the 
State plan.
    After consideration of public comments, we are finalizing paragraph 
(a) and its definitions with modifications. The definition of a risk 
corridor in Sec.  438.6(a) as a risk sharing mechanism that accounts 
for both profits and losses between the state and the MCO, PIHP, or 
PAHP. Section 438.6(a) also maintained the existing definition for 
incentive arrangements and proposed a definition for withhold 
arrangements. While we did not receive comments on those proposed 
definitions, we believe clarification is necessary as to the scope of 
these contractual arrangements. These arrangements are the methods by 
which the state may institute financial rewards on the MCO, PIHP, or 
PAHP for meeting performance targets specified in the contract. These 
arrangements, and the

[[Page 27578]]

associated regulatory framework in Sec.  438.6(b)(1) and (2), do not 
apply to financial arrangements between managed care plans and network 
providers to incent network provider behavior. We will finalize the 
definition of incentive arrangements in Sec.  438.6(a) with a technical 
correction to replace the term ``contractor'' with ``MCO, PIHP, or 
PAHP'' for consistency with the definition for withhold arrangements 
and to remove any ambiguity as to the entity that may be subject to 
such arrangements under the contract.
    In addition, we believe it is important to distinguish in the final 
rule between a withhold arrangement, subject to the requirements at 
Sec.  438.6(b)(3), and a penalty that a state would impose on a managed 
care plan through the contract. A withhold arrangement is tied to 
meeting performance targets specified in the contract that are designed 
to drive managed care plan performance in ways distinct from the 
general operational requirements under the contract. For example, 
states may use withhold arrangements (or incentive arrangements) for 
specified quality outcomes or for meeting a percentage of network 
providers that are paid in accordance with a value-based purchasing 
model. A penalty, on the other hand, is an amount of the capitation 
payment that is withheld unless the managed care plan satisfies an 
operational requirement under the contract and is not subject to the 
requirements at Sec.  438.6(b)(3). For example, a state may withhold a 
percentage of the capitation payment to penalize a managed care plan 
that does not submit timely enrollee encounter data. To clarify this 
distinction in the final rule, we are finalizing the definition for a 
withhold arrangement with additional text to distinguish it from a 
penalty, which is assessed for non-compliance with general operational 
contract requirements. We note that this does not provide federal 
authority for penalties (other than sanctions authorized under section 
1932(e) of the Act) and that penalties are subject to state authority 
under state law.
    In paragraph (b), we established the basic standards for programs 
that apply risk corridors or similar risk sharing arrangements, 
incentive arrangements, and withhold arrangements. In Sec.  
438.6(b)(1), we proposed to redesignate the existing standard (in 
current Sec.  438.6(c)(2)) that the contract include a description of 
any risk sharing mechanisms, such as reinsurance, risk corridors, or 
stop-loss limits, applied to the MCO, PIHP, or PAHP. The proposed 
regulation text included a non-exhaustive list of examples and we 
stated our intent to interpret and apply this regulation to any 
mechanism or arrangement that had the effect of sharing risk between 
the MCO, PIHP, or PAHP and the state. Given the new standards related 
to using, calculating, and reporting MLRs, we noted that states should 
consider the impact on the MLR when developing any risk sharing 
mechanisms. We did not receive comments on paragraph (b)(1) and will 
finalize as proposed with a modification to include the standard that 
was in the 2002 rule at Sec.  438.6(c)(5)(i) that was inadvertently 
omitted in the proposed rule specifying that risk-sharing mechanisms 
must be computed on an actuarially sound basis.
    In Sec.  438.6(b)(2), we proposed to redesignate the existing 
standards for incentive arrangements currently stated in Sec.  
438.6(c)(5)(iii), but with a slight modification. We proposed to add a 
new standard in Sec.  438.6(b)(2)(v) that incentive arrangements would 
have to be designed to support program initiatives tied to meaningful 
quality goals and performance measure outcomes. We also clarified that 
not conditioning the incentive payment on IGTs means that the managed 
care plan's receipt of the incentive is solely based on satisfactory 
performance and is not conditioned on the managed care plan's 
compliance with an IGT agreement. We requested comment as to whether 
the existing upper limit (5 percent) on the amount attributable to 
incentive arrangements is perceived as a barrier to designing 
performance initiatives and achieving desired outcomes and whether CMS 
must continue to set forth expectations for incentive arrangements 
between the state and managed care plans.
    We received the following comments on proposed Sec.  438.3(b)(2) 
relating to incentive arrangements for managed care plans.
    Comment: One commenter requested clarification that amounts earned 
by a managed care plan under an incentive arrangement are a separate 
funding stream in addition to the monthly capitation payment.
    Response: We confirm the commenter's understanding and believe that 
the nature of incentive arrangements is clearly defined in Sec.  
438.6(a).
    Comment: A few commenters asked if pay-for-performance arrangements 
would constitute an incentive arrangement and thereby be subject to the 
requirements in Sec.  438.6(b)(2). If pay-for-performance arrangements 
fell under the requirements for incentive arrangements in Sec.  
438.6(b)(2), commenters were concerned about the provisions in Sec.  
438.6(b)(2)(i) and (ii) that limit such arrangements to a fixed period 
of time and specify that these arrangements are not subject to 
automatic renewal.
    Response: We believe that pay-for-performance programs, if applied 
to the performance of managed care plans, may be an incentive 
arrangement or withhold arrangement under the regulations in Sec.  
438.6(b)(2) or (b)(3). The distinction depends on whether the financial 
reward to the managed care plan is in addition to the amounts received 
under the capitation payment or are based on payment of amounts 
withheld from the actuarially sound capitation payment. We address 
comments related to the requirements in Sec.  438.6(b)(2)(i) and (ii) 
below.
    Comment: Many commenters supported the retention of the limit on 
total compensation--capitation plus incentive arrangements--in Sec.  
438.6(b)(2) to 105 percent of the approved capitation payments 
attributable to the enrollees or services covered by the incentive 
arrangements, while other commenters recommended that the limit be 
increased to incentivize performance by managed care plans.
    Response: We believe that the limit on the amount of the incentive 
arrangement is appropriate to both incentivize performance by managed 
care plans, as well as cap federal expenditures for such arrangements 
as the amounts are in addition to the actuarially sound capitation 
rate. Since the 2002 regulations, this limitation has been in place to 
determine that the additional payments under an incentive arrangement 
remain actuarially sound. The proposed rule at Sec.  438.6(b)(2) and 80 
FR 31123 set forth the modifications to the existing requirements for 
incentive arrangements, which did not include removing the tie to 
actuarial soundness, and inadvertently did not retain that language in 
the regulatory text. We will finalize this paragraph to include the 
link to actuarial soundness.
    Comment: Several commenters were opposed to the provisions in Sec.  
438.6(b)(2)(i) and (ii) that incentive arrangements be for a fixed 
period of and not subject to automatic renewal. Commenters stated that 
managed care plans will only invest in efforts to gain incentives if 
they will be extended over several years and have confidence that the 
incentive payments will continue.
    Response: Since similar requirements would apply to withhold 
arrangements in Sec.  438.6(b)(3)(i) and (ii), we address these 
limitations and requirements in both contexts. The requirements that 
the incentive or withhold arrangements be

[[Page 27579]]

for a fixed period of time and not subject to automatic renewal are in 
place to ensure that the state evaluates managed care plan performance 
during the rating period for the contract in which the arrangement was 
in place and determines whether revised or new performance or quality 
measures or targets are appropriate for future contract years. These 
provisions ensure that these arrangements are dynamic and drive 
continual performance or quality improvement rather than reward 
performance over several contract periods that should become the 
minimum expectation over time. Therefore, we will retain these 
requirements for incentive and withhold arrangements; we clarify that 
performance is measured during the rating period under the contract in 
which the incentive or withhold arrangement is applied in paragraphs 
(b)(2)(i) and (b)(3)(i). A state could design a plan of performance for 
a managed care plan that would span more than one contract year, but 
the period of measure for specific performance measures within the 
broader plan for performance must be at the rating period level. This 
is because the payment of the incentive or withhold is based on the 
capitation rates for the rating period.
    Comment: Several commenters requested clarification on the 
provision in Sec.  438.6(b)(2)(iv) that incentive arrangements not be 
conditioned on Intergovernmental Transfers (IGTs). Commenters 
interpreted this provision as foreclosing IGTs as a financing mechanism 
for the non-federal share under managed care program, particularly in 
relation to public hospitals.
    Response: At 80 FR 31123, we clarified that not conditioning the 
incentive payment on IGTs meant that the managed care plan's receipt of 
the incentive is solely based on satisfactory performance and not 
conditioned on the managed care plan's compliance with an IGT 
agreement. The provision in the proposed rule at Sec.  438.6(b)(2)(iv) 
has existed since the final rule was issued in 2002 at Sec.  
438.6(c)(5)(iii)(D). In the 2002 final rule, we explained that the 
purpose of the prohibition was ``to prevent incentive arrangements in 
managed care contracts from being used as a funding mechanism between 
state agencies or state and county agencies.'' See 67 FR 41004. We 
proposed to keep this provision in the managed care regulations, at 80 
FR 31123, and restate here that a managed care plan's receipt of an 
incentive payment or amounts earned back under a withhold arrangement 
cannot be conditioned on the managed care plan providing an IGT to the 
state. To clarify this requirement, we will finalize this language in 
Sec.  438.6(b)(2)(iv) and (b)(3)(iv) (and will also use parallel 
language at Sec.  438.6(c)(2)(i)(E) for permissible approaches to 
provider payments) to specify that the incentive or withhold 
arrangement does not condition managed care plan participation on the 
managed care plan entering into or adhering to intergovernmental 
transfer agreements.
    Comment: Several commenters were supportive of the proposed 
addition of Sec.  438.6(b)(2)(v), which would require incentive 
arrangements (and withhold arrangements in Sec.  438.6(b)(3)(v)) to be 
designed to support program goals and performance measure outcomes. 
Some commenters recommended that the incentive or withhold arrangements 
be evaluated as part of the quality strategy in Sec.  438.340. Other 
commenters supported this provision so long as the goals or measures 
are attainable considering the populations served, the goals or 
measures provided prospectively to managed care plans prior to 
initiation of the measurement period, and the goals or measures are not 
subject to change mid-year.
    Response: We appreciate commenters support for the element in Sec.  
438.6(b)(2)(v) and (b)(3)(v). We agree with commenters that measures in 
place for managed care plans to achieve the incentive arrangement or 
earn withhold amounts should be reasonably attainable and that such 
goals or measures should be provided to managed care plans 
prospectively. As incentive or withhold arrangements are included in 
the contract between the state and the managed care plan, the process 
of negotiating the contract will address those concerns, as well as the 
concern that the goals or measures be in place for the duration of the 
contract period. While the requirement that the incentive or withhold 
arrangement be designed to support programmatic goals would suggest 
that the state link these arrangements to the quality strategy, we 
concur that an explicit reference is warranted. Therefore, we will add 
a reference to the quality strategy at Sec.  438.340, which is also 
consistent with the approach for payment and delivery system reform 
initiatives in Sec.  438.6(c)(2)(i)(C), to both Sec.  438.6(b)(2)(v) 
and (b)(3)(v).
    Comment: One commenter requested that CMS modify Sec.  
438.6(b)(2)(v) so that not all of the elements must be in place for 
incentive arrangements.
    Response: Proposed Sec.  438.6(b)(2)(v) provided that incentive 
arrangements must be ``necessary for the specified activities, targets, 
performance measures, and quality-based outcomes that support program 
initiatives.'' We agree with the commenter that, as written, the 
provision would require that an incentive arrangement address each of 
the elements to comply with paragraph (b)(2)(v). This was not our 
intention; rather, the text should be read as a list of different 
approaches to measuring the performance of the managed care plans 
subject to the incentive arrangement. Therefore, we will replace 
``and'' with ``or'' in that paragraph. As this is also a requirement 
for withhold arrangements in Sec.  438.6(b)(3)(v), we will modify that 
text as well. We do emphasize, however, that each element in paragraphs 
(b)(2)(i) through (v) must be met for an incentive arrangement (or, in 
connection with paragraph (b)(3)(i) through (v), a withhold 
arrangement) to be compliant with this final rule.
    After consideration of public comments, we are finalizing Sec.  
438.6(b)(2) with the following modifications: (1) In paragraph (b)(2), 
to reinsert the longstanding requirement that payments under incentive 
arrangements may not exceed 105 percent of the approved capitation rate 
``since such total payments will not be considered to be actuarially 
sound; (2) in paragraph (b)(2)(i), to add text to clarify that the 
arrangement is for a fixed period of time and performance is measured 
during the rating period under the contract in which the arrangement is 
applied; (3) in paragraph (b)(2)(iv), to add text to clarify how 
participation cannot be conditioned on entering into or complying with 
an IGT; and (4) in paragraph (b)(2)(v), to insert ``or'' in place of 
``and'' to insert a reference to the state's quality strategy at Sec.  
438.340. We are finalizing identical technical modifications in 
paragraphs Sec.  438.6(b)(3)(i), (iv) and (v).
    In paragraph (b)(3), we proposed that the capitation rate under the 
contract with the MCO, PIHP, or PAHP, minus any portion of the withhold 
amount that is not reasonably achievable, must be certified as 
actuarially sound. As an example, if the contract permits the state to 
hold back 3 percent of the final capitation rate under the contract, or 
3 percent from a particular rate cell of the capitation rate under the 
contract, the actuary must determine the portion of the withhold that 
is reasonably achievable. We requested comment on how an actuary would 
conduct such an assessment to inform future guidance in this area. If 
the actuary determines that only two thirds of the withhold is 
reasonably achievable (that is, 2 percent of the final contract 
capitation rate), the

[[Page 27580]]

capitation rate, minus the portion that is not reasonably achievable 
(that is, 1 percent of the final capitation rate), must be actuarially 
sound. The total amount of the withhold, achievable or not, must be 
reasonable and take into account an MCO's, PIHP's, or PAHP's capital 
reserves and financial operating needs for expected medical and 
administrative costs. We provided that when determining the 
reasonableness of the amount of the withhold, the actuary should also 
consider the cash flow requirements and financial operating needs of 
the MCOs, PIHPs, and PAHPs, taking into account such factors as the 
size and characteristics of the populations covered under the contract. 
In addition, we explained that the reasonableness of the amount of the 
withhold should also reflect an MCO's, PIHP's, or PAHP's capital 
reserves as measured by risk-based capital levels or other appropriate 
measures (for example, months of claims reserve) and ability of those 
reserves to address expected financial needs. The data, assumptions, 
and methodologies used to determine the portion of the withhold that is 
reasonably achievable must be included in the documentation for rate 
certification specified under Sec.  438.7(b). We noted that the 
proposed terms for the design of the withhold arrangement mirror the 
terms for incentive arrangements minus the upper limit, as the rate 
received by the MCO, PIHP, or PAHP absent the portion of withhold 
amount that is not reasonably achievable must be certified as 
actuarially sound.
    The proposed rule was designed to ensure that any withhold 
arrangements meet the following goals: (1) The withhold arrangement 
does not provide an opportunity for MCOs, PIHPs, or PAHPs to receive 
more than the actuarially certified capitation rate; (2) the withhold 
arrangement provides MCOs, PIHPs, and PAHPs an opportunity to 
reasonably achieve an amount of the withhold, such that if the state 
had set the capitation rate at the actual amount paid after accounting 
for the effect of the withhold, it would be certifiable as actuarially 
sound; and (3) the actuarial soundness of the capitation rates after 
consideration of the withhold arrangement is assessed at an aggregate 
level, across all contracted MCOs, PIHPs, or PAHPs, rather than at the 
level of an individual managed care plan. A withhold arrangement is 
applied at the contract level rather than at the rate cell level as 
there is not a practical way to accomplish the latter. For example, a 
withhold arrangement may be described as 2 percent under the contract, 
which would encompass all rate cells under the contract, rather than 
calculating and deducting the amount to be withheld per individual rate 
cell to reach 2 percent under the withhold arrangement. We welcomed 
comment on appropriate approaches to evaluating the reasonableness of 
these arrangements and the extent to which the withholds are reasonably 
achievable and solicited comment on whether our proposed regulation 
text sufficiently accomplished our stated goals.
    We received the following comments in response to proposals at 
Sec.  438.3(b)(3) relating to withhold arrangements for managed care 
plans.
    Comment: Several commenters supported the inclusion of withhold 
arrangements at Sec.  438.6(a) and (b)(3), while some commenters 
recommended that CMS only permit incentive arrangements. A few 
commenters questioned the utility of withhold arrangements to drive 
managed care plan performance when the capitation payment received by 
the managed care plan is actuarially sound.
    Response: From our experience in reviewing managed care contracts 
and rate certifications, it is clear that withhold arrangements 
represent the predominant approach to incentivizing managed care plan 
performance. For that reason we decline to prohibit such arrangements 
and maintain that regulation is appropriate in this area. We maintain, 
and state practice supports this conclusion, that withhold arrangements 
can incentivize managed care plan performance even though the monthly 
capitation payment received by the managed care plan absent the amount 
of the withhold is actuarially sound.
    Comment: A commenter suggested that states should have the 
flexibility to reward high performing managed care plans with a bonus 
payment in addition to the receipt of the withhold amount and that such 
funds would come from managed care plans that did not meet the metrics 
under the withhold arrangement. The commenter stated that this approach 
should be permissible and would be budget neutral.
    Response: Such an arrangement would have to meet the requirements 
for both withhold and incentive arrangements under Sec.  438.6(b)(2) 
and (b)(3), respectively. Incentive and withhold arrangements are 
specific to a MCO's, PIHP's, or PAHP's performance according to the 
specific metrics under the contract. The commenter stated that any 
bonus payments could be made from unearned amounts from withhold 
arrangements under the contract from managed care plans that did not 
fully meet the specified metrics of the withhold arrangement. Unearned 
amounts under a withhold arrangement do not create a residual pool of 
money to be distributed to other managed care plans operating within a 
state. If the state wanted to provide a bonus payment in addition to 
the amount paid under a withhold arrangement, that bonus payment would 
have to meet the requirements of an incentive arrangement at Sec.  
438.6(b)(2).
    Comment: A commenter requested that CMS clarify how an unearned 
portion of the withhold should be treated by states.
    Response: The withhold amount is not paid to the managed care plans 
until the conditions for payment are met by the managed care plan. 
Therefore, the state claims FFP for the amount of the withhold through 
the CMS-64 only if a managed care plan has satisfied the conditions for 
payment under the withhold arrangement and the amount has been paid to 
the managed care plan. If a managed care plan does not earn some or all 
of the withhold amount, no federal or state dollars are expended for 
those amounts.
    Comment: In response to the request for comment as to how an 
actuary would evaluate the amount of the withhold that was reasonably 
achievable, a commenter provided the following steps: review the 
language and criteria for earning the withhold for prior contract 
years; review the language and criteria for earning back the withhold 
for the rate period; assess differences between the prior year and the 
rate period; review the amounts earned by the managed care plans in 
prior years; and based on the above, extrapolate and use actuarial 
judgment to determine the achievable amount.
    Response: We believe that in many circumstances the approach 
described would be a reasonable methodology. However, it is not the 
only viable and reasonable approach. We do not believe that it is 
necessary to have a prior year of experience for the specific MCO, PIHP 
or PAHP to make such an assessment. Other data sources may also be 
appropriate. For example, the experience from other health insurance 
coverage may be an appropriate data source.
    Comment: We received several comments on the proposed ``reasonably 
achievable'' standard for withhold arrangements at Sec.  438.6(b)(3). 
Many commenters stated that the ``reasonably achievable'' standard was 
vague and too subjective. A few commenters recommended that CMS clarify 
that the actuary may rely on the state's assessment of what portion of 
the

[[Page 27581]]

withhold is or is not reasonably achievable, as it is outside the scope 
of the actuary's expertise to independently assess the reasonableness 
of the withhold amount in relation to performance expectations for each 
managed care plan. Other commenters suggested a modified standard in 
Sec.  438.6(b)(3) that the capitation rate minus any portion of the 
withhold that is not reasonably achievable by a managed care plan given 
the non-benefit load must be actuarially sound. Another commenter 
requested that CMS clarify that the need to take into account the 
managed care plan's financial operating needs be done at the broader 
level of the managed care program, rather than at the level of 
individual managed care plans, as a state should not have to forego 
applying a withhold arrangement for the managed care program overall if 
a particular managed care plan was not operating as efficiently in the 
financial sense as other managed care plans in the program.
    Many commenters suggested alternatives to the ``reasonably 
achievable'' standard for withhold arrangements. Several commenters 
recommended that a limitation of 5 percent similar to incentive 
arrangements at Sec.  438.6(b)(2) be placed on withhold arrangement, 
because without such a limitation, the capitation rates actually 
received by managed care plans if they do not earn back the withhold 
amount would not be actuarially sound. Another commenter suggested that 
the amount of the withhold be considered exempt from the actuarial 
soundness requirement so long as the amount met a CMS defined limit, 
similar to the 5 percent cap used for incentive arrangements. Other 
commenters suggested that CMS limit the withhold arrangement to no more 
than the profit percentage assumed in the rate setting process. Some 
commenters suggested that the entire amount of the withhold be excluded 
from the actuarially sound capitation rate to ensure that the amount 
received by the managed care plans remained actuarially sound absent 
receipt of funds for meeting specified performance metrics.
    Response: We thank the commenters for their feedback in this area. 
We disagree that the ``reasonably achievable'' standard is vague or 
unnecessarily subjective. A withhold is intended to incentivize a 
managed care plan to achieve, or partially achieve, articulated 
performance metrics. Depending on the selected performance metrics and 
the structure of the withhold, it may be easy or difficult to achieve 
some, or all, of the withhold. To not consider the amount of the 
withhold toward the assessment of actuarially sound capitation rates 
would significantly limit states' ability to use withholds because the 
withhold would not count toward an actuarially sound capitation rate 
(and thus not be eligible for FFP) even as managed care plans earn some 
or all of the withhold.
    Similarly, we considered counting all of the withhold amount toward 
the assessment of actuarially sound capitation rates. However, this 
approach created a risk that a managed care plan would not actually be 
paid an actuarially sound capitation rate because managed care plans 
frequently do not earn the full withhold amount. If the capitation 
rates were determined to be actuarially sound on the assumption that 
the managed care plans would earn all of the withhold, then it is 
possible that the capitation rates would not remain actuarially sound 
if a managed care plan did not meet the performance metrics. This 
situation would put the enrollee at risk.
    This provision is intended to strike a balance between the approach 
of counting all of the withhold toward actuarially sound capitation 
rates and the approach of counting none of the withhold toward 
actuarially sound capitation rates. We agree that determining the 
amount of the withhold that is reasonably achievable requires the 
actuary to exercise judgment. There may be a number of methods that 
could be used to make the determination. Historical experience may be 
relied upon as many states track managed care plans' performance on 
various quality measures over a number of years. It may also be 
possible to look at the experience in other states and estimate how 
that experience is applicable. It is also possible that there may be 
managed care plan industry metrics or metrics from other health 
insurance coverage types that could be used as a comparison. If neither 
the state, nor actuary, can provide any evidence or information that 
managed care plans can expect to earn some or all of withhold, the 
appropriate course would be to take the most cautious approach and 
assume that none of the withhold is reasonably achievable.
    States use a variety of withhold arrangements today. Setting 
arbitrary limits for withhold such as the expected profit margin could 
interfere with states' current approaches. Therefore, we decline to use 
these approaches to limit the amount of the withhold.
    Comment: Several commenters offered suggestions on how states 
should operationalize the ``reasonably achievable'' standard for 
withhold arrangements. For example, commenters recommended that states 
be required to have one full year of managed care plan reporting on the 
specific performance metrics prior to implementing any withholds. 
During the one year reporting period, the state would function as if 
the withhold was in place so that the managed care plans would 
anticipate the financial impact of nonperformance and have time to 
develop improvement strategies prior to incurring financial 
consequences.
    Other commenters supported the provision in Sec.  438.7(b)(6), and 
at 80 FR 31259, that a description of withhold arrangements (and other 
special contract provisions described in Sec.  438.6) be included in 
the rate certification, but requested that states should have to share 
the information supporting the withhold amount with managed care plans. 
Another commenter asked for clarification under Sec.  438.7(b)(6) as to 
the scope of the data, assumptions, and methodologies used to determine 
the portion of the withhold that is reasonably achievable to be 
documented in the rate certification. The commenter questioned if the 
intention was for the state to include something other than the 
metrics, methods and assumptions for those metrics, and if so, raised 
concern about the administrative burden the level of documentation 
would create.
    Response: As provided in response to a previous comment, there may 
be a number of methods that could be used to make the determination 
that a portion (or all) of a withhold amount is reasonably achievable. 
There may be historical experience that can be used. For example, many 
states track managed care plans' performance on various quality 
measures over a number of years. It may also be possible to look at the 
experience in other states and estimate how that experience is 
applicable. It is also possible that there may be managed care plan 
industry metrics or metrics from other health insurance coverage types 
that could be used as a comparison. If neither the state, nor actuary, 
can provide any evidence or information that managed care plans can 
expect to earn some or all of withhold, the appropriate course would be 
to take the most cautious approach and assume that none of the withhold 
is reasonably achievable.
    Given the states have many different performance metrics, there may 
be a variety of appropriate assumptions, data, and methodologies for 
assessing the amount of the withhold that is reasonably achievable. We 
clarify that the scope of the assumptions, data, and methodologies for 
determining the

[[Page 27582]]

amount of the withhold should include the basis for determining that 
some or all of the withhold is achievable and that information would be 
included in the rate certification. Such documentation would include 
any data, historical experience, other states' experiences, industry 
data, or other relevant information.
    After consideration of public comments, we are finalizing Sec.  
438.6(b)(3)(i), (iv) and (v) with the same modifications noted above 
for Sec.  438.6(b)(2)(i), (iv) and (v).
    We proposed to redesignate the standard at the existing Sec.  
438.6(c)(5)(v), related to adjustments to actuarially sound capitation 
rates to account for graduate medical education (GME) payments 
authorized under the state plan, at Sec.  438.6(b)(4) without any 
changes to the substantive standard.
    We received the following comments on proposed Sec.  438.6(b)(4).
    Comment: Several commenters objected to the requirement at Sec.  
438.6(b)(4) that if the state directly makes payments to network 
providers for graduate medical education (GME) costs under an approved 
State plan, the actuarially sound capitation payments must be adjusted 
to account for those GME payments.
    Response: This provision was redesignated in the proposed rule from 
the current regulation at Sec.  438.6(c)(5)(v) and is linked to the 
provision in Sec.  438.60 that permits states to make GME payments 
directly to network providers. Based on the comments received, it is 
clear that states were not consistently applying this provision. We 
agree that for states that make direct GME payments to providers, it is 
not necessary for the state for develop actuarially sound capitation 
rates prior to excluding GME payments.
    After consideration of public comments, we are not finalizing 
proposed Sec.  438.6(b)(4) (which has the effect of removing the 
provision currently codified at Sec.  438.6(c)(5)(v)) in this final 
rule but clarify here that if states require managed care plans to 
provide GME payments to providers, such costs must be included in the 
development of actuarially sound capitation rates. We will also remove 
the reference to Sec.  438.6(c)(5)(v) in Sec.  438.60 to be consistent 
with our decision not to finalize Sec.  438.6(b)(4).
    We proposed to add a new provision to Sec.  438.6(c) to codify what 
we believe was a longstanding policy on the extent to which a state may 
direct the MCO's, PIHP's or PAHP's expenditures under a risk contract. 
Existing standards in Sec.  438.6(c)(4) (proposed to be redesignated as 
Sec.  438.3(c)) limit the capitation rate paid to MCOs, PIHPs, or PAHPs 
to the cost of state plan services covered under the contract and 
associated administrative costs to provide those services to Medicaid 
eligible individuals. Furthermore, under existing standards at Sec.  
438.60, the state must ensure that additional payments are not made to 
a provider for a service covered under the contract other than payment 
to the MCO, PIHP or PAHP with specific exceptions. Current CMS policy 
has interpreted these regulations to mean that the contract with the 
MCO, PIHP or PAHP defines the comprehensive cost for the delivery of 
services under the contract, and that the MCO, PIHP or PAHP, as risk-
bearing organizations, maintain the ability to fully utilize the 
payment under that contract for the delivery of services. Therefore, in 
Sec.  438.6(c)(1), we proposed the general rule that the state may not 
direct the MCO's, PIHP's, or PAHP's expenditures under the contract, 
subject to specific exceptions proposed in paragraphs (c)(1)(i) through 
(iii).
    In the proposed rule, we noted the federal and state interest in 
strengthening delivery systems to improve access, quality, and 
efficiency throughout the health care system and in the Medicaid 
program. In support of this interest, we encouraged states that elect 
to use managed care plans in Medicaid to leverage them to assist the 
states in achieving their overall objectives for delivery system and 
payment reform and performance improvements. Consistent with this 
interest, we established a goal of empowering states to be able, at 
their discretion, to incentivize and retain certain types of providers 
to participate in the delivery of care to Medicaid beneficiaries under 
a managed care arrangement. We proposed in paragraphs (c)(1)(i) through 
(c)(1)(iii) the ways that a state may set parameters on how 
expenditures under the contract are made by the MCO, PIHP, or PAHP, 
other mechanisms would be prohibited.
    Paragraph (c)(1)(i) proposed that states may specify in the 
contract that managed care plans adopt value-based purchasing models 
for provider reimbursement. In this approach, the contract between the 
state and the managed care plan would set forth methodologies or 
approaches to provider reimbursement that prioritize achieving 
improvements in access, quality, and/or health outcomes rather than 
merely financing the provision of services. Implementing this 
flexibility in regulation would assure that these regulations promote 
paying for quality or health outcomes rather than the volume of 
services, which is consistent with broader HHS goals, as discussed in 
more detail in the proposed rule at 80 FR 31124.
    In paragraph (c)(1)(ii), we proposed that states have the 
flexibility to require managed care plan participation in broad-ranging 
delivery system reform or performance improvement initiatives. This 
approach would permit states to specify in the contract that MCOs, 
PIHPs, or PAHPs participate in multi-payer or Medicaid-specific 
initiatives, such as patient-centered medical homes, efforts to reduce 
the number of low birth weight babies, broad-based provider health 
information exchange projects, and other specific delivery system 
reform projects to improve access to services, among others. We 
acknowledge that, despite the discussion at 80 FR 31124 about the 
ability to engage managed care plans in Medicaid-specific initiatives, 
we unintentionally omitted these initiatives from the proposed 
regulatory text at Sec.  438.6(c)(1)(ii). Under our proposal, states 
could use the managed care plan payments as a tool to incentivize 
providers to participate in particular initiatives that operate 
according to state-established and uniform conditions for participation 
and eligibility for additional payments. The capitation rates to the 
managed care plans would reflect an amount for incentive payments to 
providers for meeting performance targets but the managed care plans 
would retain control over the amount and frequency of payments. We 
noted that this approach balances the need to have a managed care plan 
participate in a multi-payer or community-wide initiative, while giving 
the managed care plan a measure of control to participate as an equal 
collaborator with other payers and participants. We also clarified that 
because funds associated with delivery system reform or performance 
initiatives are part of the capitation payment, any unspent funds 
remain with the MCO, PIHP, or PAHP. We also stated our belief that the 
overall regulatory approach to identify mechanisms that permit states 
to direct MCO, PHIP, or PAHP expenditures was designed to ensure that 
payments associated with a reform initiative are also tied to the 
relative value of the initiative as demonstrated through the 
utilization of services or quality outcomes. As an example of a 
delivery system reform initiative, we provided that states could make 
available incentive payments for the use of technology that supports 
interoperable health information exchange by network providers that 
were not eligible for EHR

[[Page 27583]]

incentive payments under the HITECH Act (for example, long-term/post-
acute care, behavioral health, and home and community based providers).
    We proposed in paragraph (c)(1)(iii) to permit states to require 
certain payment levels for MCOs, PIHPs and PAHPs to support two state 
practices critical to ensuring timely access to high-quality, 
integrated care, specifically: (1) setting minimum reimbursement 
standards or fee schedules for providers that deliver a particular 
covered service; and (2) raising provider rates in an effort to enhance 
the accessibility or quality of covered services. For example, some 
states have opted to voluntarily pay primary care providers at Medicare 
reimbursement rates beyond CYs 2013-2014, which was the time period 
required for such payment levels under section 1202 of the Affordable 
Care Act. Because actuarially sound capitation rates are based on all 
reasonable, appropriate and attainable costs (see section I.B.3.b. of 
the final rule), the contractual expectation that primary care 
providers would be paid at least according to Medicare reimbursement 
levels must be accounted for in pricing the primary care component of 
the capitation rate. These amounts would be subject to the same 
actuarial adjustments as the service component of the rate and would be 
built into the final contract rate certified by the actuary. Under the 
contract, the state would direct the MCO, PIHP, or PAHP to adopt a fee 
schedule created by the state for services rendered by that class of 
providers. As proposed, paragraph (c)(1)(iii)(A) would permit states to 
direct payment levels for all providers of a particular service as 
contemplated in this scenario.
    In paragraph (c)(1)(iii)(B), we noted the state could specify a 
uniform dollar or percentage increase for all providers that provide a 
particular service under the contract. This option would have the state 
treat all providers of the services equally and would not permit the 
state to direct the MCO, PIHP, or PAHP to reimburse specific providers 
specific amounts at specified intervals. We noted that this option 
would help ensure that additional funding is directed toward enhancing 
services and ensuring access rather than benefitting particular 
providers. It would also support the standard that total reimbursement 
to a provider is based on utilization and the quality of services 
delivered. Finally, we also noted that this option would be consistent 
with and build upon the existing standard that the capitation rate 
reflects the costs of services under the contract. Under both 
approaches in (c)(1)(iii), the MCO, PIHP or PAHP could negotiate higher 
payment amounts to network providers under their specific network 
provider agreements.
    Sections 438.6(c)(2)(i) and (ii) set forth proposed approval 
criteria for approaches under paragraphs (c)(1)(i) through (iii) to 
ensure that the arrangement is consistent with the specific provisions 
of this section. To ensure that state direction of expenditures 
promotes delivery system or provider payment initiatives, we expected 
that states would, as part of the federal approval process, demonstrate 
that such arrangements are based on utilization and the delivery of 
high-quality services, as specified in paragraph (c)(2)(i)(A). Our 
review would also ensure that state directed expenditures support the 
delivery of covered services. Consequently, we expected that states 
would demonstrate that all providers of the service are being treated 
equally, including both public and private providers, as specified in 
paragraph (c)(2)(i)(B). In proposed paragraph (c)(2)(i)(C) and (D), we 
linked approval of the arrangement to supporting at least one of the 
objectives in the comprehensive quality strategy in Sec.  438.340 and 
that the state would implement an evaluation plan to measure how the 
arrangement supports that objective. This would enable us and states to 
demonstrate that these arrangements are effective in achieving their 
goals. In proposed paragraph (c)(2)(i)(E), to promote the extent to 
which these arrangements support proactive efforts to improve care 
delivery and reduce costs, we would prohibit conditioning provider 
participation in these arrangements on intergovernmental transfer 
agreements. Finally, in proposed paragraph (c)(2)(i)(F), because we 
sought to evaluate and measure the impact of these reforms, such 
agreements would not be renewed automatically.
    Under proposed paragraph (c)(2)(ii), we specified that any contract 
arrangement that directs expenditures made by the MCO, PIHP, or PAHP 
under paragraphs (c)(1)(i) or (c)(1)(ii) for delivery system or 
provider payment initiatives would use a common set of performance 
measures across all payers and providers. Having a set of common 
performance measures would be critical to evaluate the degree to which 
multi-payer efforts or Medicaid-specific initiatives achieve the stated 
goals of the collaboration. We sought comment on the proposed general 
standard, and the three exceptions, providing a state the ability to 
direct MCO's, PIHP's, or PAHP's expenditures. Specifically, we sought 
comment on the extent to which the three exceptions were adequate to 
support efforts to improve population health and better care at lower 
cost, while maintaining MCO's, PIHP's or PAHP's ability to fully 
utilize the payment under that contract for the delivery of services to 
which that value was assigned.
    We received the following comments in response to proposed Sec.  
438.6(c).
    Comment: Many commenters supported proposed Sec.  438.6(c)(1)(i) 
and (ii) as broad approaches to support value-based purchasing and 
delivery system reform. Specifically, commenters supported mechanisms 
to advance patient-centered quality outcomes, value-based purchasing 
models, multi-payer delivery system reforms, performance improvement 
initiatives, and other promising delivery system reforms that could 
improve care for Medicaid enrollees. A few commenters that supported 
Sec.  438.6(c)(1) recommended that CMS include regulatory text for 
specific models of care. A few commenters recommended that CMS provide 
regulatory support for Medicaid Accountable Care Organizations (ACOs) 
and other community-based health care models, health homes, patient-
centered medical homes, bundled payments, and episodes of care. Other 
commenters recommended that CMS include specific financial incentives 
to encourage states to begin implementing value-based purchasing and 
begin transitioning their health care delivery systems from volume to 
value. A few commenters recommended against CMS pursuing value-based 
purchasing. One commenter stated that according to a recent 
Congressional testimony by MedPAC, there is little to no evidence that 
value-based purchasing programs actually produce savings. One commenter 
recommended that CMS implement value-based purchasing gradually to 
ensure that such delivery system models actually produce results and 
savings.
    Response: As proposed and finalized here, Sec.  438.3(c)(1)(i) is 
intended to permit states to require their MCOs, PIHPs or PAHPs to use 
value-based purchasing methods for provider reimbursement as an 
exception to the general rule specified in paragraph (c)(1) regarding 
state direction of managed care plan expenditures under the contract. 
It is not a requirement that states do so although we encourage states 
to engage their managed care plans, the provider community, and other 
stakeholders to consider arrangements that would be appropriate for 
their Medicaid programs. We recognize that the evaluation of the

[[Page 27584]]

efficacy of value-based purchasing methods is ongoing and that several 
models are either in place or under consideration by states. Value-
based purchasing is also a priority for the Department as discussed at 
80 FR 31124. We decline to implement specific financial incentives for 
states to undertake value-based purchasing initiatives as such 
financial incentives would require specific federal statutory funding 
authority. States have the flexibility to use incentive or withhold 
arrangements as specified in Sec.  438.6(b)(2) and (3) to encourage 
managed care plans to adopt such payment models.
    Comment: Several commenters recommended that CMS include specific 
protections under Sec.  438.6(c)(1)(i) for patients with special health 
care needs or high cost conditions for states and managed care plans to 
monitor how new payment models ensure access to quality care. A few 
commenters recommended that CMS add protections for vulnerable 
populations accessing innovative therapies that might initially drive 
costs up but could ultimately improve a patient's outcomes in the long-
term. A few commenters recommended that CMS include regulatory language 
that would protect dual eligible enrollees, frail seniors, enrollees 
with behavioral health needs, enrollees with disabilities under the age 
of 65, and enrollees receiving LTSS from inadvertently being impacted 
by value-based purchasing models.
    Response: States have the flexibility to determine which services 
would be reimbursed through value-based purchasing models as such 
models may not be appropriate for all services and populations covered 
under the contract. Regardless of the reimbursement models used by the 
contracted managed care plans, all enrollee protections for access and 
availability of care in part 438 apply. Therefore, we do not believe it 
is necessary to specify additional protections in relation to value-
based purchasing models.
    Comment: Several commenters recommended that CMS include specific 
stakeholder engagement and public notice requirements at Sec.  438.6(c) 
before states implement delivery system reform initiatives under Sec.  
438.6(c)(1)(ii). Several commenters recommended that CMS include 
specific transparency requirements and seek stakeholder feedback on 
value-based payment arrangements that the state intends to include in 
managed care plan contracts under Sec.  438.6(c)(1)(i).
    Response: We decline to add such requirements to Sec.  438.6(c); we 
believe that these concerns are adequately addressed by other 
disclosure and stakeholder involvement requirements. Public notice 
requirements apply to waiver and state plan authorities for managed 
care programs. In addition, such delivery reform initiatives would be 
appropriately discussed at the state's Medical Care Advisory Committee 
(MCAC), which is required under Sec.  431.12, or at a Member Advisory 
Committee, which is required under Sec.  438.110, if such initiatives 
involved the MLTSS program. In addition, such performance or quality 
measures would be included in the state's annual program report at 
Sec.  438.66(e)(2)(vii), which is made available on the state's Web 
site and shared with the MCAC at Sec.  438.66(e)(3).
    We received the following comments in response to the example of 
incentive payments to network providers for EHR adoption that are not 
eligible for incentives under the HITECH Act.
    Comment: Many commenters supported regulatory flexibility for 
states to make available incentive payments for the use of technology 
that supports interoperable health information exchange by network 
providers that were not eligible for EHR incentive payments under the 
HITECH Act. Commenters stated that by allowing and offering EHR 
incentives to a wider range of health care programs and providers, CMS 
enables the delivery of coordinated care and seamless information 
sharing across the health care continuum. Several commenters 
recommended that CMS provide guidance to states and other contracting 
entities suggesting that state-based EHR incentive programs must 
leverage ONC certification criteria for data exchange so that the same 
standards and methods of data transfer are used for state-incented EHR 
programs as are used for the Meaningful Use program. Commenters 
recommended that CMS clarify and finalize this provision to ensure 
states can efficiently and effectively take advantage of these 
incentive payments.
    Response: We appreciate commenters support for the example (at 80 
FR 31124) of how proposed Sec.  438.6(c)(1)(iii) would permit states to 
incent EHR adoption by providers that were not eligible for incentives 
under the HITECH Act. The discussion in the preamble provided 
suggestions for states to consider for broad ranging delivery system 
reform or performance improvement initiatives and did not result in a 
new regulatory framework for states that desired to establish a state-
incented EHR program for providers. That being said, states that 
desired to create such an initiative would benefit from taking the 
existing ONC certification criteria for data exchange into account to 
support an EHR system that was consistent with systems for providers 
covered under the HITECH Act.
    Comment: A few commenters recommended that CMS include requirements 
at Sec.  438.6(c) to support team-based care in any delivery system 
reform initiative under Sec.  438.6(c)(1)(ii). Specifically, commenters 
recommended that CMS include language that would support advanced 
practice registered nurses (APRNs) and certified registered nurse 
anesthetists (CRNAs) in state delivery system reform efforts. A few 
commenters recommended that CMS specify managed care plan provider 
reimbursement levels for community pharmacists in regulation.
    Response: Each state's Medicaid managed care program is unique and 
the states are best positioned, in collaboration with managed care 
plans and stakeholders, to design delivery system reform efforts. 
Therefore, we decline to specify particular initiatives through 
regulation.
    Comment: A few commenters stated concern that the regulatory 
language at paragraphs Sec.  438.6(c)(1)(i) through (iii) could be 
misinterpreted as a complete list of the permissible limitations states 
can impose on managed care plan expenditures. Commenters stated that 
this overlooks the fact that the state's contract must direct the 
managed care plans expenditures to the extent that such expenditures 
are mandated under the statute and related regulations. Commenters 
provided that one example of this type of requirement is payment levels 
for federally-qualified health centers. Commenters recommended that CMS 
modify the text in paragraph (c)(1) to acknowledge payments that may be 
required under statute.
    Response: We have modified the statement of the general rule at 
Sec.  438.6(c)(1) to include exceptions for specific provisions of 
Title XIX, or a regulation implementing a Title XIX provision related 
to payments to providers that is applicable to managed care programs.
    Comment: We received comments both for and against our proposal at 
Sec.  438.6(c)(1)(iii) regarding state establishment of minimum 
reimbursement requirements for network providers. Several commenters 
did not support proposed Sec.  438.6(c)(1)(iii)(A) and (B) regarding a 
minimum fee schedule for all providers that provide a particular 
service under the managed care contract or a uniform dollar or 
percentage increase for all

[[Page 27585]]

providers that provide a particular service under the managed care 
contract. Commenters stated that the proposed regulatory language 
conflicts with the overarching construct of managed care under which 
the payer does not dictate how managed care plans must use the 
capitated payment to fulfill the requirements specified in the 
contract. Commenters stated that minimum fee schedule requirements 
interfered with managed care plan provider rate negotiations and that 
provisions requiring minimum payment rates for providers could stifle 
innovation by inserting the state into managed care plan-provider 
relationships. Commenters recommended that CMS withdraw these 
requirements as they remove the managed care plan's ability to 
effectively manage utilization costs and raise concerns about the 
ability of managed care plans to measure quality improvements in 
providing services through the issuance of uniform rates. Other 
commenters were concerned that these proposed provisions would 
eliminate providers' abilities to negotiate higher provider payment 
rates with managed care plans if states are allowed to set standard fee 
schedules.
    Several commenters supported proposed Sec.  438.6(c)(1)(iii)(A) and 
(B) but recommended that CMS include additional requirements. Some 
commenters requested clarification as to the parameters for a minimum 
fee schedule. Several commenters recommended that CMS set a national 
floor for minimum provider fee schedules for all managed care plans at 
the Medicare reimbursement rate to improve access to care for all 
Medicaid managed care enrollees. One commenter recommended that CMS 
require states to include the methods and procedures related to rates 
that the state mandates that a managed care plan pay to a provider in 
the state's Medicaid state plan, and that CMS review and approve such 
methods and rates to ensure adequate access to care. A few commenters 
recommended that CMS require any minimum fee schedule to reflect an 
adequate living wage for health care providers sufficient to live in 
the communities they serve. One commenter recommended that CMS expand 
the requirement to allow states to establish both minimum and maximum 
fee schedules for all providers that provide a particular service under 
the managed care contract.
    Response: As proposed and finalized here, Sec.  438.6(c)(1)(iii)(A) 
and (B) is intended to permit--not mandate--states to require their 
contracted managed care plans reimburse providers that provide a 
particular service in accordance with a minimum fee schedule or at a 
uniform dollar or percentage increase as an exception to the general 
rule specified in paragraph (c)(1) regarding state direction of managed 
care plan expenditures under the contract. It is not a requirement that 
states do so. We restate that these provisions would permit the state 
to specify a minimum payment threshold and would not prohibit the 
managed care plans from negotiating higher provider rates. To clarify 
the parameters for the state in setting a fee schedule for particular 
network providers under the contract, we will add a new paragraph 
(c)(1)(iii)(C) to specify that states could include a maximum fee 
schedule in the managed care plan contract, so long as the managed care 
plan retains the ability to reasonably manage risk and have discretion 
in accomplishing the goals of the contract. An example of a maximum fee 
schedule that would satisfy this requirement is that the managed care 
plan could pay no more than a specified percentage of a benchmark rate, 
such as Medicare or commercial rates. The use of minimum or maximum fee 
schedule or uniform increases ensures that provider payment initiatives 
are tied to the utilization and delivery of particular services under 
the contract. In the event the state used these provisions under the 
contract, the minimum payment expectations would be taken into account 
in the rate development process. However, for consistency with changes 
in the final rule at Sec.  438.6(c)(2)(i)(B), described in response to 
comments on that provision below, we will finalize Sec.  
438.6(c)(1)(iii)(A) and (B) without the proposed requirement that the 
minimum fee schedule or uniform dollar or percentage increase in 
provider payments apply to all providers that provide a particular 
service under the contract.
    We cannot establish a national floor for network provider payments 
without explicit statutory authority. We decline to specify that any 
minimum fee schedule reflect a living wage for the providers subject to 
such a fee schedule. In addition, we decline to incorporate such 
minimum provider payment amounts in the State plan as the State plan 
only governs FFS provider payments.
    Comment: A few commenters did not support the proposed regulatory 
language at Sec.  438.6(c)(2). Commenters stated that the regulatory 
language unfairly restricted the state's policy making authority, was 
unduly burdensome, and did not provide any meaningful evaluation 
criteria to enhance CMS's approval beyond the approval process for the 
plan as a whole. Commenters recommended that as an alternative to the 
pre-approval process, CMS require states to sufficiently document and 
support directed payment programs within the rate development and 
contract approval process.
    Response: We disagree with commenters that the provisions in Sec.  
438.6(c)(2) are unduly burdensome and inhibit state policy goals. This 
section does not require an approval separate from the contract and 
rate certification because approval of these initiatives would be part 
of this review. In light of comments received on specific provisions 
within Sec.  438.6(c)(2), we are finalizing that section with some 
modifications as described below.
    Comment: Many commenters recommended that CMS include requirements 
at Sec.  438.6(c)(2) to ensure that states have conducted readiness 
reviews to ensure providers are ready for delivery system reform and 
have the ability to successfully participate in delivery system reform 
initiatives before implementation. Commenters also recommended that CMS 
include requirements that protect providers at risk for managed care 
plan performance for quality and efficiency objectives that rest solely 
within the control of managed care plan administrators. Commenters 
recommended that CMS prohibit plans from passing risk to providers 
resulting from state withhold and incentive arrangements. One commenter 
recommended that CMS clarify that managed care plans are only required 
to make a best effort to encourage providers to participate in delivery 
system reform.
    Response: We appreciate that success of value-based purchasing 
models or other delivery system reforms are predicated on the readiness 
of affected parties--namely, managed care plans and affected 
providers--to undertake the operational and other considerations to 
implement and sustain these approaches. Section 438.66(d)(4) sets forth 
the broad categories of a managed care plan's operations that are 
subject to evaluation during a readiness review. While we believe that 
operations, service delivery, and financial management are sufficiently 
broad to capture value-based purchasing or other delivery system 
reforms under the contract, we acknowledged in the proposed rule, at 80 
FR 31158, that states have the flexibility to evaluate additional 
aspects of the managed care plan during the readiness review. 
Considering the resources necessary to implement, oversee, and achieve

[[Page 27586]]

meaningful delivery system reform, we encourage states to assess the 
readiness of managed care plans to partner in those efforts.
    Comment: Several commenters recommended that CMS include 
requirements that states may not require FQHCs to assume risk for 
services beyond primary and preventive care as a prerequisite for 
obtaining a managed care provider agreement. Commenters provided that 
FQHCs are prohibited from using section 330 funding for any services 
outside their scope, which is typically limited to primary and 
preventive care and requested a new paragraph in Sec.  438.6(c)(2)(i) 
to acknowledge that FQHCs cannot be required to assume risk for 
additional services as a condition for obtaining a managed care 
provider agreement.
    Response: The determination to apply value-based purchasing models, 
delivery system reform initiatives, or performance improvement 
initiatives to a particular provider type must take into account 
statutorily mandated payment levels or methodologies, as well as 
additional considerations such as conditions for grant funding from 
other federal agencies. We recognize that provider types in addition to 
FQHCs may have similar concerns; therefore, it would not be appropriate 
to specify one provider type, as the commenter recommended, to the 
exclusion of others in the regulation. However, depending on a 
provider's particular treatment under Title XIX, we clarify here that 
value-based purchasing methodologies or other performance initiatives 
may not interfere with federal statutory mandates, including payment 
methodologies.
    Comment: Several commenters did not support proposed Sec.  
438.6(c)(2)(i)(B) which requires states to direct expenditures equally 
for all public and private providers providing the same service under 
the contract. Commenters recommended that states be permitted to direct 
payments to certain provider types within a service classification 
without having to include all providers of that same service under a 
singular payment initiative. Commenters also recommended that states 
not be held to unreasonable uniformity requirements when pursuing next 
generation, value-based payment initiatives, because these programs are 
designed to target only certain providers within a category. Many 
commenters recommended that CMS clarify and allow states to direct 
payment amounts for certain services to providers of differing types, 
specialties, and settings.
    Response: We agree with commenters that the proposal at Sec.  
438.6(c)(2)(i)(B), which would have required states to direct 
expenditures under the approach selected at Sec.  438.6(c)(1)(i) 
through (iii) to all public and private providers providing the same 
service under the contract, was unnecessarily restrictive and could 
have inhibited a state's policy goals for the Medicaid program. 
Therefore, we will finalize this section to specify that the 
expenditures are directed equally, and using the same terms of 
performance, for a class of providers providing the service under the 
contract. This modification will permit states to limit a fee schedule, 
value-based purchasing arrangement, or delivery system reform or 
performance improvement initiative to public hospitals, teaching 
hospitals, or other classification of providers. Similarly, we have 
modified Sec.  438.6(c)(2)(ii)(A) to remove the requirement that 
participation in value-based purchasing initiatives, delivery system 
reform, or performance improvement initiatives be made available to 
both public and private providers subject to the initiative and are 
replacing it with a requirement that such initiatives be available to a 
class of providers.
    Comment: Several commenters did not support proposed Sec.  
438.6(c)(2)(i)(E) which would prohibit states from conditioning 
provider participation in a delivery system reform initiative based on 
intergovernmental transfer agreements. Some commenters requested that 
CMS permit flexibility on proposed limits or restrictions regarding 
intergovernmental transfers while others stated that the proposal 
should be withdrawn entirely. Other commenters requested further 
clarification on the extent to which the prohibition against 
conditioning provider participation on intergovernmental transfer 
arrangements would restrict increased capitation payment programs where 
the non-federal share component is based entirely on voluntary local 
contributions.
    Response: Section 438.6(c)(2)(i)(E) means that the network 
provider's participation in a contract arrangement under paragraphs 
(c)(1)(i) through (c)(1)(iii) cannot be conditioned on the network 
provider entering into or adhering to an IGT agreement. The approaches 
in Sec.  438.6(c)(1)(i) through (iii) are permissible ways under the 
managed care contract to set minimum payment requirements or 
reimbursement models or to incent quality outcomes. These approaches 
recognize the role of the provider in the delivery of services rather 
than as a source of the non-federal share. Therefore, it is imperative 
that provider eligibility to receive payments under these provisions 
can only be conditioned on the delivery of services in the instances of 
minimum provider fee schedules or value based purchasing models or the 
achievement of specified performance measures. We will finalize Sec.  
438.6(c)(2)(i)(E) to clarify that the network provider's participation 
in the contract arrangements at paragraphs (c)(1)(i) through (iii) is 
not conditioned on the network provider entering or adhering to an IGT 
agreement; this change is discussed in more detail in connection with 
Sec.  438.6(b)(2)(i) through (v) and (b)(3)(i) through (v) above.
    Comment: One commenter recommended that CMS revise proposed Sec.  
438.6(c)(2)(i)(F) from ``not to be renewed automatically'' to ``may not 
be renewed automatically'' so that the phrase makes a complete sentence 
when paired with the lead-in phrase.
    Response: We appreciate the commenters suggestion and will finalize 
Sec.  438.6(c)(2)(i)(F) with that change.
    Comment: Many commenters stated concerns regarding proposed Sec.  
438.6(c)(2)(ii)(A) and (B) regarding performance measures. Several 
commenters recommended that CMS provide flexibility when it comes to 
managed care plan requirements of performance measurement for 
providers. Commenters stated that there is too much variation in 
provider setting, specialty, and patient population characteristics to 
require all providers to focus on the same performance measures. One 
commenter recommended that CMS require the quality performance measures 
utilized in the Medicaid quality rating system (QRS) to provide the 
foundation for the performance measurement approach used to define 
health outcomes. Other commenters recommended that CMS prescribe 
specific performance measures in tracking value, such as those related 
to preventable admissions, spending per patient, emergency room visits, 
and adverse inpatient events. Commenters also recommended the 
utilization of patient reported measures (PRM), which can support 
understanding of how patients do over time and to assess care 
performance. Some commenters recommended specific performance measures 
for MLTSS programs. One commenter recommended that managed care plan 
contracts include performance incentives and penalties tied to 
achieving change in the integration and coordination of services across 
systems and improving population health.
    Response: We appreciate commenters' suggestions for the types of 
performance measures that should be part of a state's delivery system 
reform efforts; however, we decline to specify particular

[[Page 27587]]

measures or approaches in regulation to provide states with appropriate 
flexibility to target initiatives that meet the needs of their specific 
Medicaid programs.
    Comment: Many commenters disagreed with proposed Sec.  
438.6(c)(2)(ii)(D) which prohibits the state from recouping any unspent 
funds allocated for delivery system or provider payment initiatives 
from the managed care plan. Commenters recommended that the final rule 
permit states to share in the savings with managed care plans, with the 
terms for doing so specified in the negotiated agreement. Several 
commenters recommended that unspent funds be reinvested with high-
quality providers or returned to the state Medicaid program to reinvest 
in other delivery system reform initiatives.
    Response: Managed care plans receive risk-based capitation payments 
to carry out the obligations under the contract. Section 438.6(c) 
establishes parameters by which the state can direct expenditures under 
the contract. As funds associated with delivery system reform or 
performance initiatives are part of the risk-based capitation payment, 
any unspent funds remain with the MCO, PIHP, or PAHP.
    Comment: Several commenters recommended that CMS provide a clear 
regulatory path for value-based or delivery system reform payments to 
be considered in rate setting. Commenters recommended that CMS provide 
a linkage between proposed Sec. Sec.  438.5 and 438.6(c) to clarify 
that payments made under a value-based purchasing model, where 
improvements in population health driven by managed care plans and 
their providers reduced the volume of encounters, can be considered as 
an allowable component of rate development. Some commenters stated that 
implementing delivery system reforms has administrative cost 
implications, including data analysis, program design and monitoring, 
and contract development activities. Commenters stated that these costs 
need to be considered in actuarial soundness analyses and included in 
the administrative component of the capitation rate. Commenters also 
recommended that managed care plans not be penalized in any MLR 
calculations as a result of having to spend additional administrative 
dollars to undertake these activities.
    Response: Section 438.7(b)(6) requires that the rate certification 
describe any special contract providers related to payment in Sec.  
438.6(c). In addition, Sec.  438.5(e) pertaining to the non-benefit 
component of the capitation rate development includes other operational 
costs, which could accommodate administrative expenses incurred in the 
operation of delivery reform efforts under the contract. The MLR 
calculation standards finalized in this rule for the numerator at Sec.  
438.8(e)(3)(i), relating to activities that improve health care 
quality, encompass value-based purchasing or other delivery system 
reforms; therefore, we do not believe that there is a concern about 
penalizing managed care plans in the MLR calculation in this context. 
Section Sec.  438.8(e)(3)(i) incorporates 45 CFR 158.150(b) and that 
provision sets forth criteria for activities that improve health care 
quality in a manner that would accommodate such approaches. Therefore, 
we do not believe additional specificity is necessary in regulation.
    Comment: Many commenters disagreed with proposed Sec.  438.6(c)(1) 
and specified that limiting state direction of payments under the 
managed care plan contract has never been a longstanding policy of CMS 
before this proposed rule. Several commenters stated that there is no 
federal statute prohibiting a state from directing the expenditures of 
an MCO, PIHP, or PAHP and recommended that CMS remove the language at 
Sec.  438.6(c)(1). Many commenters recommended that CMS allow 
flexibility for delivery system reform programs to reflect state and 
local realities, allowing states and managed care plans to design 
quality and value-based purchasing efforts to target providers and 
direct payments to drive overall improvement in care delivery and 
access to care. Other commenters stated that CMS' characterization in 
the proposed rule was inaccurate given that CMS has approved managed 
care plan arrangements that involve requirements for managed care plans 
to make minimum payments for designated providers.
    Many commenters stated specific concerns regarding proposed Sec.  
438.6(c)(1) and stated that the regulatory language creates inequality 
in the use of supplemental payments in managed care compared to FFS 
programs. Commenters stated that by making it more difficult for states 
to use supplemental payments in managed care, it would dis-incentivize 
the use of the managed care delivery model. Commenters stated that the 
proposed regulatory language would limit the full functionality of 
Medicaid managed care in driving quality and value for Medicaid 
beneficiaries. Commenters stated that CMS' regulatory approach would 
inhibit state flexibility to produce the next generation of 
transformative innovations and that the proposed new restrictions could 
create the potential for a major destabilization of state health care 
delivery systems. Commenters recommended that rather than restricting 
the use of supplemental payments in broad and inappropriate ways, CMS 
should pursue alternative approaches to promote transparency around 
these payments. Commenters stated that such an approach would help the 
agency achieve its policy goals while ensuring the policy is not a 
barrier to the use of Medicaid managed care or other innovation.
    Many commenters recommended that CMS modify the proposed language 
to provide additional flexibility for states to direct expenditures to 
promote access to services for safety-net providers and tailor payment 
models, for specific class of provider type. Commenters recommended 
that CMS include a fourth exception (to be codified at a new Sec.  
438.6(c)(1)(iv)) to allow states to direct managed care payments to 
promote access to and retain certain types of safety-net providers, 
including public hospitals and public health systems to ensure that 
Medicaid can retain essential community providers. Many commenters 
stated that the proposed language would destabilize their safety-net 
provider systems and block states from targeting additional Medicaid 
support to providers with the largest Medicaid patient populations and 
acknowledging the role and extra burden these safety-net providers bear 
and their inability to subsidize low reimbursement rates.
    Response: We agree with commenters that it is critical for states 
to have flexibility in using their Medicaid managed care programs to 
drive value for beneficiaries through improved quality, better care 
coordination, and reduced costs. We also agree with commenters that the 
regulatory approach should not serve as a barrier to innovation and to 
transformative payment approaches. However, we believe that the 
statutory requirement that capitation payments to managed care plans be 
actuarially sound requires that payments under the managed care 
contract align with the provision of services to beneficiaries covered 
under the contract. Aligning provider payments with the provision of 
services through managed care contracts is also necessary to support 
improved care delivery and transformative innovation. In our review of 
managed care capitation rates, we have found pass-through payments 
being directed to specific providers that are generally not directly 
linked to delivered services or the outcomes of those services. These 
pass-through payments are not

[[Page 27588]]

consistent with actuarially sound rates and do not tie provider 
payments with the provision of services.
    For purposes of this final rule, we define pass-through payments at 
Sec.  438.6(a) as any amount required by the state to be added to the 
contracted payment rates between the MCO, PIHP, or PAHP and hospitals, 
physicians, or nursing facilities that is not for the following 
purposes: A specific service or benefit covered under the contract and 
provided to a specific enrollee; a provider payment methodology 
permitted under Sec.  438.6(c)(1)(i) through (c)(1)(iii) for services 
and enrollees covered under the contract; a subcapitated payment 
arrangement for a specific set of services and enrollees covered under 
the contract; GME payments; or FQHC or RHC wrap around payments. This 
definition is consistent with the definition for pass-through payments 
in CMS' 2016 Medicaid Managed Care Rate Guidance.
    Accordingly, our final rule phases out the ability of states to use 
pass-through payments by allowing states to direct MCO, PIHP and PAHP 
expenditures only based on the utilization, delivery of services to 
enrollees covered under the contract, or the quality and outcomes of 
services. However, because we recognize that pass-through payments are 
often an important revenue source for safety-net providers and some 
commenters requested a delayed implementation of the provision at Sec.  
438.6(c), the final rule will allow transition periods for pass-through 
payments to hospitals, physicians and nursing facilities to enable 
affected providers, states, and managed care plans to transition pass-
through payments into payments tied to services covered under the 
contract, value-based payment structures, or delivery system reform 
initiatives without undermining access for the beneficiaries they 
serve.
    To clearly address the issues raised by commenters, it is helpful 
to clarify the statutory and regulatory differences between provider 
payments under FFS and managed care programs. In the case of FFS, 
section 1902(a)(30)(A) of the Act requires that payment for care and 
services under an approved state plan be consistent with efficiency, 
economy, and quality of care. Regulations implementing section 
1902(a)(30)(A) of the Act permit states considerable flexibility in 
structuring FFS rates, but impose aggregate upper payment limits (UPLs) 
on rates for certain types of services or provider types. For 
institutional providers, these UPLs are generally based on Medicare 
payment methodologies. Additionally, these UPLs determine the maximum 
amount of federal funding, or FFP, that is available for services 
through these institutional providers. Many states have used the 
flexibility under FFS to structure rates to include both base payment 
rates and supplemental rates, with the supplemental rates in some cases 
reflecting individual provider circumstances, such as the volume of 
uncompensated care. Since aggregate supplemental payments, when added 
to the aggregate base payments, cannot exceed the UPL, the supplemental 
payments are sometimes tied directly to the UPL calculation.
    To draw down the federal share of an expenditure for a provider 
payment, including expenditures for supplemental payments, states must 
document an expenditure that includes a non-federal share. Supplemental 
payments are typically funded by intergovernmental transfers (IGTs) 
from local governments, by certified public expenditures (CPEs) from 
public providers, or by provider taxes, all of which are permissible 
sources of the nonfederal share of Medicaid spending. As states have 
faced budget pressures, states have sought various approaches to 
maintain existing Medicaid coverage and to avoid reducing benefits for 
beneficiaries. One approach used to address these challenges has been 
to increase supplemental payments funded through IGTs, CPEs and 
provider taxes. Over time, these supplemental payments have become an 
important and significant revenue stream to certain provider types.
    The increase in supplemental payments is frequently associated with 
lower base payment rates to providers. In fact, in some situations 
supplemental payment revenues exceed revenues from the Medicaid base 
rates.\8\ Paying lower base rates raises questions about whether 
provider rates are sufficient to ensure quality of and access to care, 
and whether adding or increasing supplemental payments to these lower 
base rates is sufficient to maintain access and quality across all 
providers. Moreover, in some cases these supplemental payment 
mechanisms are contingent on some providers' ability and willingness to 
provide the nonfederal share through intergovernmental transfers or 
certified public expenditures rather than on the providers' provision 
of services or the efficiency or quality of those services. In 
reviewing supplemental payments, we often find it difficult to 
demonstrate their linkage to services, utilization, quality, or 
outcomes.
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    \8\ MACPAC, ``MACfacts Key Findings on Medicaid and CHIP: 
Medical UPL Supplemental Payments'' (Nov 2012), available at https://www.macpac.gov/wp-content/uploads/2015/01/MACFacts-UPL-Payments_2012-11.pdf.
---------------------------------------------------------------------------

    In contrast to FFS, section 1903(m)(2)(A)(iii) of the Act provides 
the requirements for the payment for care and services under managed 
care. Section 1903(m)(2)(A)(iii) of the Act requires contracts between 
states and MCOs to provide capitation payments for services and 
associated administrative costs that are actuarially sound. The 
underlying concept of managed care and actuarial soundness is that the 
state is transferring the risk of providing services to the MCO and is 
paying the MCO an amount that is reasonable, appropriate, and 
attainable compared to the costs associated with providing the services 
in a free market. Inherent in the transfer of risk to the MCO is the 
concept that the MCO has both the ability and the responsibility to 
utilize the funding under that contract to manage the contractual 
requirements for the delivery of services. Further, unlike FFS, which 
uses maximum aggregate caps to limit the amount of FFP available, 
managed care limits the amount of FFP to the actuarially sound 
capitation rate paid to the managed care plan, which is based on the 
amount of funding that is reasonable and appropriate for the managed 
care plan to deliver the services covered under the contract. We also 
note here that the actuarial soundness requirements apply statutorily 
to MCOs under section 1903(m)(2)(A)(ii) of the Act and were extended to 
PIHPs and PAHPs under our authority in section 1902(a)(4) of the Act in 
the 2002 final rule.
    Because the capitation payment that states make to a managed care 
plan is expected to cover all reasonable, appropriate, and attainable 
costs associated with providing the services under the contract, the 
statutory provision for managed care payment does not anticipate a 
supplemental payment mechanism. Managed care plans are expected to 
utilize capitation payments made under a contract to cover all 
reasonable, appropriate and attainable costs associated with providing 
the services under the contract. We do not believe that section 
1903(m)(2)(A)(ii) of the Act permits managed care payments that are not 
directly related to the delivery of services under the contract, 
because it requires actuarially sound payments for the provision of 
services and associated administrative obligations under the managed 
care contract.
    We disagree with the assertion of commenters that limiting state 
direction of payments under the managed care plan contract has not been 
a federal policy before the proposed rule. As

[[Page 27589]]

discussed at 80 FR 31123, Sec.  438.6(c)(4) (redesignated at Sec.  
438.3(c) in this final rule) limits the capitation rate paid to MCOs, 
PIHPs, or PAHPs to the cost of state plan services covered under the 
contract and associated administrative costs to provide those services 
to Medicaid eligible individuals. Furthermore, under Sec.  438.60, the 
state must ensure that additional payments are not made to a provider 
for a service covered under the contract other than payment to the MCO, 
PIHP or PAHP with specific exceptions. We have interpreted these 
regulations to mean that the contract with the MCO, PIHP or PAHP 
defines the comprehensive cost for the delivery of services under the 
contract, and that MCOs, PIHPs or PAHPs, as risk-bearing organizations, 
maintain the ability and responsibility to fully utilize the payment 
under that contract for the delivery of services.
    Current managed care regulations at Sec.  438.60 expressly prohibit 
the state from making a payment to a provider for services available 
under the contract between the state and the managed care plan. As a 
matter of policy, we have interpreted Sec.  438.60 to mean that states 
are also prohibited from making a supplemental payment to a provider 
through a managed care plan, which is referred to as a ``pass-through'' 
payment, as discussed earlier.
    The rationale for this policy interpretation is that the payment to 
the managed care plan is for the provision of services under the 
contract, in which the managed care plan is responsible for negotiating 
contracts with providers. If the state is making a pass-through payment 
by requiring a managed care plan to pay network providers in a manner 
that is not related to the delivery of services, this situation is no 
different than the state making a payment outside of the contract 
directly to providers. Put another way, the pass-through payment 
requirements do not align payment to the managed care plan or providers 
with the provision of services.
    Despite CMS' interpretation of Sec.  438.60, a number of states 
have integrated some form of pass-through payments into their managed 
care contracts for hospitals, nursing facilities, and physicians. In 
general, the size and number of the pass-through payments for hospitals 
has been more significant than for nursing facilities and physicians. 
There are multiple reasons that states have implemented pass-through 
payments into their managed care contracts. Commonly, states that have 
moved from FFS to managed care have sought to ensure a consistent 
payment stream for certain critical safety-net hospitals and providers 
and to avoid disrupting existing IGT, CPE, and provider tax mechanisms 
associated with the supplemental payments.
    The amount of the pass-through payment often represent a 
significant portion of the overall capitation rate under the contract. 
We have seen supplemental payments that have represented 25 percent, or 
more, of the overall contract and 50 percent of individual rate cells. 
The rationale for these pass-through payments in the development of the 
capitation rates is often not transparent and it is not clear what the 
relationship of these pass-through payments is to the requirement for 
actuarially sound rates. Additionally, not directly connecting provider 
payments to the delivery of services also compromises the ability of 
managed care plans to manage their contractual responsibilities for the 
delivery of services.
    We are concerned that pass-through payments may limit a managed 
care plan's ability to effectively use value-based purchasing 
strategies and implement quality initiatives. As in FFS, the existence 
of pass-through payments may affect the amount that a managed care plan 
is willing or able to pay for the delivery of services through its base 
rates or fee schedule. In addition, pass-through payments make it more 
difficult to implement quality initiatives or to direct beneficiaries' 
utilization of services to higher quality providers because a portion 
of the capitation rate under the contract is independent of the 
services delivered. Put another way, when the fee schedule for services 
is set below the normal market, or negotiated, rate to account for 
pass-through payments, moving utilization to higher quality providers 
can be difficult because there may not be adequate funding available to 
incentivize the provider to accept the increased utilization. In 
addition, when pass-through payments guarantee a portion of a 
provider's payment and divorces the payment from service delivery, it 
is more challenging for managed care plans to negotiate provider 
contracts with incentives focused on outcomes and managing individuals' 
overall care.
    We understand that many states are interested in directing efforts 
through contracts with MCOs, PIHPs, or PAHPs to improve and integrate 
care, enhance quality, and reduce costs. Some states have also had an 
interest in using their Medicaid program, which is often one of the 
largest payers in a state, to promote market-wide delivery and payment 
changes in collaboration with other insurers in the state. We have 
clarified elsewhere in our response to comments that Sec.  438.6(c) 
provides explicit mechanisms to support innovative efforts to transform 
care delivery and payment. Section 438.6(c)(1)(i) allows states to 
contractually require managed care plans to adopt value-based 
purchasing approaches for provider reimbursement. In addition, section 
438.6(c)(1)(ii) allows states to require managed care plan 
participation in multi-payer, market-wide delivery system reform, or 
Medicaid-specific delivery system reform or performance improvement 
initiatives. Finally, Sec.  438.6(c)(1)(iii) allows states to specify 
minimum and maximum provider fee schedules. The provisions of Sec.  
438.6(c) provide significant flexibility for states to use their 
Medicaid managed care program to implement initiatives to improve and 
integrate care, enhance quality, and reduce costs. However, Sec.  
438.6(c)(2)(i)(A) and (B) maintains our approach in the proposed rule 
to require that the payment arrangements be based on the utilization, 
delivery of services, and performance under the contract. As a whole, 
Sec.  438.6(c) maintains the MCO's, PIHP's, or PAHP's ability to fully 
utilize the payment under that contract for the delivery and quality of 
services by limiting states' ability to require payments that are not 
directly associated with services delivered to enrollees covered under 
the contract.
    While we do not believe that pass-through payments are consistent 
with actuarially sound rates and do not align provider payments with 
the provision of services, we also acknowledge pass-through payments 
have served as critical source of support for safety net providers who 
provide care to Medicaid beneficiaries. We also share commenters 
concerns that an abrupt end to pass-through payments could create 
significant disruptions for some safety-net providers who serve 
Medicaid managed care enrollees. As such, we are retaining our proposal 
to transition pass-through payments into value-based payment 
structures, delivery system reform initiatives, or payments tied to 
services under the contract as provided in Sec.  438.6(c)(1)(i) through 
(iii).
    We recognize the challenges associated with transitioning pass-
through payments into payments for the delivery of services covered 
under the contract to enrollees or value-based payment structures for 
such services. The transition from one payment structure to another 
requires robust provider and stakeholder engagement, agreement on 
approaches to care delivery and payment, establishing systems for 
measuring outcomes and

[[Page 27590]]

quality, planning, and evaluating the potential impact of change on 
Medicaid financing mechanisms. Many states and state Medicaid programs 
are actively working through many of these issues as part of efforts to 
move toward value-based purchasing, but the process often takes 
substantial time and attention. We recognize that implementing value-
based payment structures, other delivery system reform initiatives and 
working through these transition issues, including ensuring adequate 
base rates, is central to both delivery system reform and to 
strengthening access, quality and efficiency in the Medicaid program. 
Ensuring that actuarially sound capitation rates include adequate 
provider payments is one of the reasons that Sec.  438.4(b)(3) requires 
an evaluation of the adequacy of the capitation rates to meet the 
requirements on MCOs, PIHPs, and PAHPs in Sec. Sec.  438.206, 438.207, 
and 438.208 for the availability of services and support coordination 
and continuity of care. We also note that Sec.  438.6(c)(2)(i)(B), 
which permits any of the approaches in Sec.  438.6(c)(1)(i) through 
(iii) to be directed toward specific classes of providers, is a tool 
through which states and managed care plans can support payment rates 
that are directly tied to services.
    In an effort to provide a smooth transition for network providers, 
to support access for the beneficiaries they serve, and to provide 
states and managed care plans with adequate time to design and 
implement payment systems that link provider reimbursement with 
services covered under the contract or associated quality outcomes, we 
will finalize this rule with a new Sec.  438.6(d) that provides for 
transition periods related to pass-through payments for specified 
providers. The rule provides a 10-year transition period for hospitals, 
subject to limitations on the amount of pass-through payments in Sec.  
438.6(d)(2) through (3). After July 1, 2027, states will not be 
permitted to require pass-through payments for hospitals under a MCO, 
PIHP, or PAHP contract. The rule also provides a 5-year transition 
period for pass-through payments to physicians and nursing facilities. 
After July 1, 2022, states will not be permitted to require pass-
through payments for physicians and nursing facilities under a MCO, 
PIHP, or PAHP contract. After July 1, 2022, for physicians and nursing 
facilities, and after July 1, 2027 for hospitals, only the approaches 
in Sec.  438.6(c)(1)(i) through (iii) will be permitted mechanisms for 
states to direct the MCO's, PIHP's or PAHP's expenditures under the 
contract. This transition period provides states, network providers, 
and managed care plans time and flexibility to integrate pass-through 
payment arrangements into different payment structures, including 
enhanced fee schedules or the other approaches consistent with Sec.  
438.6(c)(1)(i) through (c)(1)(iii) under actuarially sound capitation 
rates.
    Section 438.6(d) sets forth the time frames and requirements for 
transitioning pass-through payments to payment structures linked to 
delivered services for hospitals, physicians, and nursing facilities. 
We have created transition periods for the payment structures for the 
three provider types acknowledged in Sec.  438.6(d), because these are 
the primary provider types to which states make UPL and other 
supplemental payments under state plan authority, which states have 
typically sought to continue making as pass-through payments under 
managed care programs.
    It is important to note that Sec.  438.6(d) provides different 
periods for hospitals versus nursing facilities and physicians. States 
are also required to phase down hospital pass-through payments, but do 
not have the same requirement for physicians and nursing facilities. 
This distinction in the treatment of hospitals versus physicians and 
nursing facilities under Sec.  438.6(d) is based on the difference in 
number and dollar amount of pass-through payments to these different 
provider types under managed care today. Pass-through payments to 
hospitals are significantly larger than the pass-through payments to 
physicians and nursing facilities. We recognize that states and 
hospitals may use a variety of payment approaches to link payments to 
services and outcomes. Understanding that it will take significant time 
to design and implement alternative approaches consistent with the 
final rule and the amount of funding involved, we provided a longer 
time period to transition pass-through payments to hospitals. We also 
provide for a phased transition with annual milestones. Having these 
milestones is particularly important for hospital payments where states 
may use multiple approaches to achieving the goal of complying with the 
final rule.
    We believe that states will be able to more easily transition pass-
through payments to physicians and nursing facilities to payment 
structures linked to services covered under the contract. Consequently, 
we have provided a shorter time period for eliminating pass-through 
payments to physicians and nursing facilities, but have also not 
required a prescribed phase down for these payments, although states 
have the option to phase down these payments if they prefer. The 
distinction between hospitals and nursing facilities and physicians is 
also based on the comments from stakeholders during the public comment 
period to the proposed rule. We received many comments on the 
disruptive nature to hospitals and beneficiary access if such pass-
through arrangements were abruptly eliminated. Similar concerns were 
not raised with respect to payments to physicians and nursing 
facilities.
    To determine the total amount of pass-through payments to hospitals 
that may be included in the MCO, PIHP or PAHP contracts in any given 
contract year under the final rule, a state must calculate a base 
amount and then reduce the base amount by the schedule provided in 
Sec.  438.6(d)(3). The base amount is defined at Sec.  438.6(a) as the 
amount available for pass-through payments to hospitals in a given 
contract year subject to the schedule for the reduction of the base 
amount in paragraph (d)(3). For contracts beginning on or after July 1, 
2017, a state would be able to make pass-through payments for hospitals 
under the contract up to the full ``base amount'' as defined in Sec.  
438.6(a).
    The portion of the base amount calculated in Sec.  438.6(d)(2)(i) 
is analogous to performing UPL calculations under a FFS delivery 
system, using payments from managed care plans for Medicaid managed 
care hospital services in place of the state's payments for FFS 
hospital services under the state plan. The portion of the base amount 
calculated in Sec.  438.6(d)(2)(ii) takes into account hospital 
services and populations included in managed care during the rating 
period that includes pass-through payments which were in FFS 2 years 
prior. This timeframe and use of 2-year old data is in place so that 
the state has complete utilization data for the service type that would 
be subject to pass-through payments. We point out that the base amount 
includes both inpatient and outpatient hospital services. Therefore, 
the calculation of the base amount in Sec.  438.6(d)(2) is calculated 
using a four-step process:
     Step One: Identify the hospital services that will be 
provided for the populations under managed care contracts in the time 
period for which the base amount of pass-through payments is being 
calculated.
     Step Two: For the hospital services identified in Step One 
that were provided to the relevant populations under managed care 
contracts for the 12-month period immediately 2 years

[[Page 27591]]

prior to the time period for which the base amount for pass-through 
payments is being calculated, compare reasonable estimates of the 
aggregate difference between: (a) The amount Medicare would have paid 
for those hospital services as utilized under the MCO, PIHP, or PAHP 
contracts 2 years prior; and (b) the amount MCOs, PIHPs, or PAHPs paid 
(not including pass through payments) for those hospital services 
utilized under the MCO, PIHP, or PAHP contracts for the 12-month period 
immediately 2 years prior.
     Step Three: For the hospital services identified in Step 
One that were provided to the relevant populations under FFS during the 
2 years immediately prior to the time period for which the base amount 
is being calculated, compare actual or reasonable estimates of the 
aggregate difference between: (a) The amount Medicare FFS would have 
paid for those hospital services as utilized under FFS two years prior; 
and (b) the amount the state paid under FFS (not including supplemental 
payments) for those hospital services utilized 2 years prior. This step 
is in place to acknowledge situations where hospital services may not 
have been covered for some populations during the period for which the 
base amount of pass-through payments is calculated.
     Step Four: Sum the reasonable estimates of the aggregate 
differences calculated in Step Two and Step Three.
    As an example, for contracts starting on July 1, 2017, the base 
amount is derived for the hospital services and the populations that 
will be included in the July 1, 2017 managed care contracts. For those 
hospital services and populations, the difference between what Medicare 
FFS would have paid for the hospital services utilized in 2015 (under 
Medicaid managed care and/or Medicaid FFS, as appropriate) and the 
actual Medicaid payments for the hospital services utilized in 2015 
(under managed care and/or FFS, as appropriate) represents the base 
amount. This method for establishing the base amount, which uses the 
aggregate difference between Medicaid and Medicare reimbursement for 
actual hospital utilization, is directly analogous to the calculations 
of a hospital UPL payment under Medicaid FFS and is, therefore, a 
familiar exercise for many states.
    Building on the similarity to the FFS hospital UPL calculations, in 
Sec.  438.6(d)(2)(iv), we permit states to make reasonable estimates of 
the aggregate differences in Steps Two and Three in accordance with the 
hospital upper payment limit requirements under 42 CFR part 447 and 
described in CMS' hospital UPL guidance, available at https://www.medicaid.gov/medicaid-chip-program-information/by-topics/financing-and-reimbursement/accountability-guidance.html.
    Section 438.6(d)(2)(iii) establishes that the base amount is 
calculated by the state on an annual basis and is recalculated 
annually. This annual recalculation is done to account for various 
factors which impact hospital service utilization over time such as 
changes in enrollment, fee schedules, and service mix.
    The schedule for the phased reduction of the base amount of pass-
through payments to hospitals is specified at Sec.  438.6(d)(3). As 
mentioned above, for contracts beginning on or after July 1, 2017, the 
state may require pass-through payments to hospitals under the contract 
up to the base amount. For subsequent contract years (contracts 
beginning on or after July 1, 2018 through contracts beginning on or 
after July 1, 2026), the available amount of pass-through payments 
decreases by 10 percentage points per year. To illustrate, for 
contracts beginning on or after July 1, 2018, 90 percent of the base 
amount is available to be included as pass-through payments under the 
contract. Per this schedule, contracts beginning on or after July 1, 
2026, can include 10 percent of the base amount as pass-through 
payments. For contracts starting on or after July 1, 2027, no pass-
through payments are permitted. In addition, this schedule applies 
regardless of when a state elects to include pass-through payments. If 
a state elected to include pass-through payments starting for contracts 
on or after July 1, 2018, rather than 2017, the amount available for 
pass-through payments is 90 percent of the base amount. We note that 
nothing in this paragraph would prohibit a state from eliminating pass-
through payments to hospitals before contracts starting on or after 
July 1, 2027. However, we provided for a phased reduction in the 
percentage of the base amount that can be used for pass-through 
payments, anticipating that a phased transition would support the 
development of stronger payment approaches while mitigating any 
disruption to states and providers.
    Section 438.6(d)(4) specifies that the calculation of the base 
amount must be included in the rate certification required under Sec.  
438.7. The documentation must include the following: A description of 
the data, methodologies, and assumptions used to calculate the base 
amount; each calculated component of the base amount in Sec.  
438.6(d)(2)(i) through (ii); and the calculation of the applicable 
percentage of the base amount available for pass-through payments under 
the schedule in paragraph (d)(3). These additional documentation 
requirements only apply when the contract with the state requires MCOs, 
PIHPs or PAHPs to make pass-through payments and the state is relying 
on Sec.  438.6(d) rather than an exception identified in Sec.  438.6(c) 
to direct the MCO's, PIHP's or PAHP's expenditures.
    At Sec.  438.6(d)(5), for contracts starting on or after July 1, 
2017, pass-through payments would be permitted for physicians and 
nursing facilities at any amount; this means that pass-through payments 
for physicians and nursing facilities are not subject to the base 
amount calculation at paragraph (d)(2) or the schedule for pass-through 
payments at paragraph (d)(3) that are applicable to hospitals. However, 
the transition period for pass-through payments to physicians and 
nursing facilities is shorter than that provided for hospitals. Pass-
through payments for physicians and nursing facilities are permitted 
for a total of 5 years ending with contracts that begin on or after 
July 1, 2022. This transition period for pass-through payments to 
physicians and nursing facilities is in place to provide states maximum 
flexibility over the 5 year period that such payments may be made under 
managed care contracts. Again, the rationale for the shorter transition 
timeframe is based on our understanding that these payments are 
generally smaller than the pass-through payments attributable to 
hospitals and, therefore, the process of tying the payments more 
directly to services will be less disruptive. States could elect to 
take an approach that incrementally phases down the amount of pass-
through payments to these provider types or to eliminate pass-through 
payments immediately or a period less than 5 years.
    Therefore, after consideration of the public comments, we are 
finalizing the proposals at Sec.  438.6(c) with the following 
modifications:
     Clarified the statutory and regulatory requirements under 
Title XIX, as applicable to managed care programs, that would be 
exceptions to the general rule at Sec.  438.6(c)(1).
     Modified Sec. Sec.  438.3(c)(1)(iii)(A) and (B) to remove 
the proposed requirement that a minimum fee schedule or uniform dollar 
or percentage increase in provider payments apply to all providers that 
provide a particular service under the contract and made a technical 
modification to insert ``network'' before ``providers'' in each of 
these paragraphs.

[[Page 27592]]

     Added a new Sec.  438.6(c)(1)(iii)(C) to specify that 
states can include a maximum fee schedule in managed care plan 
contracts, so long as the managed care plan retains the ability to 
reasonably manage risk and have discretion in accomplishing the goals 
of the contract.
     Clarified Sec.  438.6(c)(2) that expenditures under Sec.  
438.6(c)(1)(i) through (iiii) must be developed in accordance with 
Sec. Sec.  438.4, 438.5, and generally accepted principles and 
practices.
     Changed Sec. Sec.  438.6(c)(2)(i)(B) and 
438.6(c)(2)(ii)(A) to permit states to direct expenditures or make 
participation in value-based purchasing, delivery system reform, or 
performance improvement initiatives to a class of providers rather than 
to all public and private providers under the contract.
     Revised Sec.  438.6(c)(2)(i)(E) to clarify that the 
network provider's participation in a contract arrangement under 
paragraphs (c)(1)(i) through (c)(1)(iii) is not conditioned on the 
network provider entering or adhering to an IGT agreement.
    In addition, we are finalizing Sec.  438.6 with a new paragraph (d) 
to define pass-through payments, to permit pass-through payments to 
hospitals subject to a specific calculation and schedule so that the 
availability of pass-through payments for hospitals under managed care 
contracts ceases for contracts starting on or after July 1, 2027. This 
new paragraph permits pass-through payments for physicians and nursing 
facilities for contracts starting on or after July 1, 2017 through 
contracts starting on or after July 1, 2021.
    At 80 FR 31125, we stated our belief that the regulations in part 
438 were not a barrier to the operation of programs that promote 
wellness among beneficiaries by Medicaid managed care plans. We advised 
states and managed care plans that undertake efforts to reward 
beneficiary health care decisions and behaviors through inexpensive 
gifts or services to consult OIG guidance for compliance with section 
1128A(a)(5) of the Act. See, for example, OIG, Special Advisory 
Bulletin: Offering Gifts and Other Inducements to Beneficiaries (August 
2002), available at http://oig.hhs.gov/fraud/docs/alertsandbulletins/SABGiftsandInducements.pdf.
    We received the following comments on the preamble discussion on 
wellness initiatives.
    Comment: Several commenters supported the preamble language in the 
proposed rule at 80 FR 31125 to promote wellness among beneficiaries by 
managed care plans and recommended that CMS add regulatory language to 
support wellness initiatives. Commenters also recommended that CMS 
clarify section 1128A(a)(5) of the Act and the OIG guidance bulletin by 
discussing more completely the scope and applicability related to 
wellness incentives. Several commenters recommended that CMS develop a 
more flexible policy for the promotion of Medicaid wellness programs by 
aligning its rewards and incentives policy for Medicaid managed care 
with that of MA at Sec.  422.134 in the interest of treating enrollees 
of both programs similarly and ensuring that the incentives are 
sufficient in the Medicaid population to motivate healthy behavior.
    Response: The discussion of enrollee wellness incentives offered by 
managed care plans at 80 FR 31125 clarified that part 438 did not 
prohibit such arrangements but that such arrangements should be 
developed in consultation with the OIG's Special Advisory Bulletin or 
through an opinion from the OIG. In light of the ongoing evaluation of 
the Medicaid Incentives for the Prevention of Chronic Diseases (MIPCD) 
program authorized under section 4108 of the Affordable Care Act, we 
believe it is prudent to consider additional guidance in this area that 
is informed by the lessons learned under that program. We are not 
adopting a final rule that would incorporate reward and incentive 
authority for Medicaid managed care that is similar to authority for MA 
organizations under Sec.  422.134.
e. Rate Certification Submission (Sec.  438.7)
    In new Sec.  438.7, we proposed the content of the rate 
certification that is submitted by the state for CMS review and 
approval. This section is distinguished from the rate development 
standards in Sec.  438.5 in that it focuses on documentation of rate 
development as opposed to the actual steps taken by states and 
actuaries to develop capitation rates. This section includes a new 
proposal that states receive CMS' approval of the rate certification in 
addition to the contract, as provided in Sec.  438.3(a). The rate 
certification is part of the procedural mechanism for CMS to ensure 
that the capitated rates payable to MCOs, PIHPs, and PAHPs are 
actuarially sound as specified in section 1903(m)(2)(A)(iii) of the 
Act. We proposed that rate certifications in Sec.  438.7(a) follow the 
same procedures as for contract submissions through a cross-reference 
to Sec.  438.3(a). Our proposal therefore included the regulatory 
flexibility to set forth timeframes and more detailed processes for the 
submission of the rate certification review and approval process in 
subregulatory guidance, which is in addition to the specific proposed 
standard that states seeking contract and rate approval prior to an 
anticipated effective date should submit such contracts and rate 
certifications to us no later than 90 days before anticipated effective 
date. We believe that review and approval of the rate certification 
separate from the approval of a contract is an integral step to work 
with states to ensure appropriate rates under these programs and to 
modernize our oversight of Medicaid managed care rate setting 
practices. In addition, we provided that this approach will streamline 
the approval process as the rate certification supports the payment 
terms in the contract. We explained that section 1903(m)(2)(A)(iii) 
authorizes us to stipulate review and approval of both the contract and 
the rate certification for MCOs as the contract must include the 
payment rates, which are developed via the rate certification. 
Consistent with existing standards for our review and approval for PIHP 
and PAHP contract in Sec.  438.6(a) (redesignated as Sec.  438.3(a) in 
this final rule), we proposed to extend the review and approval 
standards for the rate certification for PIHPs and PAHPs under our 
authority under section 1902(a)(4) of the Act. Under our proposal, the 
rate certification would describe and provide the necessary 
documentation and evidence that the rates were developed consistent 
with generally accepted actuarial principles and practices and 
applicable regulatory standards. In the event that the certification 
and the contract are submitted to us at different times, we noted in 
the proposed rule that we would approve the rate certification prior to 
approval of the contract but that FFP for the program would be 
contingent upon approval of the contract. Our statutory authority to 
oversee the Medicaid program and to ensure that capitation rates are 
actuarially sound, which in turn helps states and managed care plans to 
improve access to and quality of care for Medicaid beneficiaries, would 
be met by review of the documentation we proposed to require.
    We received the following comments on proposed Sec.  438.7 
generally.
    Comment: We received many comments of support for the proposed 
provisions in Sec.  438.7. Commenters supported the increased oversight 
and transparency of the rate certification process, the amount and 
scope of documentation required to be submitted, and the active review 
and approval role of CMS. We also received one comment stating that the 
proposed rule is far too prescriptive in the level

[[Page 27593]]

of detail required for CMS review and approval of rates. This commenter 
believed that CMS should respect the work of the actuaries rather than 
checking each and every calculation they perform.
    Response: We appreciate commenters' support for the provisions of 
Sec.  438.7 and disagree that the requirements for the documentation in 
the rate certification submitted for CMS' review is overly 
prescriptive. In our view, the requirements proposed and finalized at 
Sec.  438.7 reflect a level of detail and documentation in the rate 
certification that is supported by generally accepted actuarial 
standards and practices. It is not CMS' intent to check or verify every 
calculation that is performed to develop the rate certification; 
rather, the standards in Sec.  438.7 support a level of documentation 
and detail that enable CMS to understand the actions that were taken by 
the actuary when developing the capitation rates.
    Comment: Consistent with comments on the use of the terms 
``sufficient'' or ``adequate'' in Sec.  438.5, we also received 
comments about the subjectivity of the term ``adequate'' to describe 
the level of documentation throughout Sec.  438.7
    Response: According to the Merriam-Webster dictionary (accessed 
online), the simple definition of ``adequate'' is sufficient for a 
specific requirement or of a quality that is good or acceptable. 
Section 438.7 describes the level of documentation in the rate 
certification to support the rate development standards which is not 
associated with the characteristics of a particular Medicaid program. 
For that reason, Sec.  438.7 will be finalized with use of the adverb 
``adequately'' throughout so that it is clear that information must be 
adequately documented with enough detail.
    We received the following comments on proposed Sec.  438.7(a).
    Comment: We received many comments on proposed Sec.  438.7(a) 
regarding the submission of the certification 90 days in advance of the 
rates' effective date. A few commenters supported this provision while 
most believed 90 days was too long. Commenters suggested 30-45 days as 
a more appropriate time frame. Commenters believed that such an early 
submission would result in states using data that is less timely, which 
raises concerns with accuracy of developed rates. Commenters explained 
that actuaries at the state level generally take 60 days or more to 
conduct their analysis and establish rates. For states to meet the 
proposed 90 day state submission deadline, the data used for rates will 
be almost 6 months old by the time of the contract effective date, at a 
minimum. The commenters stated that the 90 day time frame would limit 
the State's ability to capture the latest policy and budget changes in 
the rate development process.
    Response: As described in response to similar comments to Sec.  
438.3(a), we disagree with commenters that requested a 45 day timeframe 
for the submission of rate certifications to mitigate concerns of the 
actuary relying on older data for rate setting purposes to meet the 90 
day timeframe. Section 438.5(c)(2) would require states and their 
actuaries to use appropriate base data with the basis of the data being 
no older than the 3 most recent and complete years prior to the rating 
period. The additional claims data that would be used in a rate 
development process that would accommodate a 45 day timeframe for 
submission to CMS, rather than a 90 day timeframe, is not actuarially 
significant.
    Comment: We received many comments on the release of the 
information in the state's submission to the managed care plans and the 
public. Commenters believed Sec.  438.7(a) should be revised to require 
states to share the information, methodologies, assumptions, procedures 
and data used in the development of the capitation rates. Some 
commenters believed this should be done at the same time as the 
submission is made to CMS, while others suggested release before 
submitting to CMS or after CMS approval but before implementation.
    Response: As provided in response to comments on Sec.  438.3(a), we 
acknowledge the valuable input that providers and other stakeholders 
have to offer to inform the development of a state's managed care 
program and there are public notice and engagement requirements to 
facilitate that process. However, the direct parties to the contracting 
process are the state and the managed care plans. We do not believe it 
would be reasonable to institute a federal requirement that would 
permit public comment or review of the rate certification. Similarly, 
we decline to require states to share the information, methodologies, 
assumptions, procedures and data used in the development of the 
capitation rates. Such requests could be made by the managed care plans 
of the states during the contract negotiation phase.
    Comment: We received several comments requesting that CMS add a 
provision to Sec.  438.7(a) for an appeal process of the actuarial 
soundness of capitation rates for managed care plans to utilize. One 
commenter believed managed care plans should be able to appeal an 
agency determination of actuarial soundness based on additional 
information that was not reflected in the development of the capitation 
rates. Another commenter suggested a process for managed care plans to 
bring concerns about the actuarial soundness of the methodology and its 
implementation to CMS for review and possible adjustment.
    Response: The actuarial soundness requirement in section 
1903(m)(2)(A)(iii) of the Act is met by our determination that 
capitation are actuarially sound and eligible for FFP; it is not a 
mechanism for CMS to be an arbiter of payment disputes between the 
state and managed care plans. Managed care plans have the option of not 
contracting with states if they believe the capitation rates are too 
low to reflect the populations, services, and other obligations under 
the contract. To help ensure that the rate setting process results in 
actuarially sound capitation rates, managed care plans have every 
incentive to provide complete and accurate base data to the state. That 
being said, we are available to meet with managed care plans informally 
during the review of capitation rates to hear and consider their 
concerns. Further, our approval of the capitation rates is a final 
administrative action.
    Comment: We received a few comments requesting that CMS guarantee 
the confidentiality of any proprietary managed care plan data that 
states submit to CMS.
    Response: To the extent applicable, the Freedom of Information Act 
(FOIA) and the Trade Secrets Act protect the confidentiality of 
proprietary information submitted to the federal government. However, 
applicable confidentiality requirements do not restrict the authority 
of the Office of the Inspector General to access records under the 
Inspector General Act of 1978,
    Comment: We received one comment requesting clarification on 
whether a community rating model is still an available rating model.
    Response: We interpret this comment to mean that the community 
rating model would not differentiate capitation rates by age or 
potentially other factors. The concept is not necessarily relevant in 
Medicaid where enrollees typically do not pay a premium. It is not 
clear what advantage a state would have in using community rating when 
the amount the state pays is presumably the same whether age or 
community rating is used.
    After consideration of public comments, we are finalizing Sec.  
438.7(a) as proposed.

[[Page 27594]]

    Section 438.7(b) sets forth the content that must be in the rate 
certification to initiate the CMS review process. In paragraph (b)(1), 
the certification would describe the base data. The rate certification 
would describe how the actuary used professional judgment to determine 
which data was appropriate after examination of all data sources and 
the data sources used, as well as reasons if the other data sources 
provided to the actuary were not used in the rate development process.
    We did not receive comments on Sec.  438.7(b)(1) and will finalize 
as proposed.
    In paragraph (b)(2), we proposed specific documentation standards 
for trend. We proposed that the rate certification be detailed enough 
so that CMS or an actuary can understand and evaluate the development 
and reasonableness of the trend and any meaningful differences among 
trend factors applied across rate cells, populations, or services. 
Comments relating to trend were addressed in response to comments 
received on Sec.  438.5(d), we did not receive comments specific to 
Sec.  438.7(b)(2). We are finalizing Sec.  438.7(b)(2) as proposed.
    In paragraph (b)(3), we proposed that the basis for determining the 
non-benefit component of the rate must be included in the actuarial 
certification with enough detail so we or an actuary can understand 
each type of non-benefit expense and evaluate the reasonableness of 
each cost assumption underlying each non-benefit expense.
    We received the following comments on proposed Sec.  438.7(b)(3).
    Comment: We received a few comments on proposed Sec.  438.7(b)(3). 
One commenter requested clarification on whether documentation is 
needed on each element if a state breaks down the general 
administrative component into assumptions regarding marketing, medical 
management, rent, corporate overhead, cost of equipment, depreciation, 
etc. but excludes certain expenses such as lobbying, political 
contributions, and management cost in excess of actual cost. Another 
commenter suggested that Sec.  438.7(b)(3) be revised to indicate that 
the non-benefit component may be developed in as much detail as 
identified in the proposed rule or in an aggregated way such that the 
total administrative and underwriting gain components are reasonable, 
appropriate, and attainable.
    Response: We addressed a similar comment in response to Sec.  
438.5(b)(3) and (e). Section 438.7(b)(3) provides that the development 
of the non-benefit component of the capitation rate must be adequately 
described so that CMS or an actuary applying generally accepted 
actuarially principles and practices can identify each type of non-
benefit expense and evaluate the reasonableness of the cost assumptions 
underlying each expense. Sections 438.5(b)(3) and (e), as finalized, 
list the following types of non-benefit expenses: Administration; 
taxes, licensing and regulatory fees; contribution to reserves; risk 
margin; cost of capital; and other operational costs. While the 
documentation of the non-benefit component cannot combine all of these 
items into a single rating factor, it would be permissible for the 
actuary to document the non-benefit costs according to the following 
groupings: administration; taxes, licensing and regulatory fees; 
contribution to reserves, risk margin, cost of capital, and other 
operational costs. Section 438.7(b)(3) has been modified to clarify the 
documentation requirements for non-benefit costs by cross-referencing 
Sec.  438.5(e).
    After consideration of public comments, we are finalizing Sec.  
438.7(b)(3) with the clarification that non-benefit costs may not be 
documented as a single rating factor but may be documented according to 
the types of non-benefit costs listed in the section.
    In paragraphs (b)(4)(i) through (iii), we proposed standards for 
transparency in the rate certification on how the material adjustments 
were developed and the reasonableness of the adjustment for the 
population, the cost impacts of each material adjustment and where in 
the rate development process the adjustment was applied. We understand 
there may be multiple adjustments applied in the rate setting process, 
ranging from minor adjustments (which on their own do not impact the 
overall rate by a material amount), to material adjustments (which may 
be much greater in scope and magnitude). Therefore, we proposed that 
states only provide information on the development of and cost impact 
for each of the material adjustments. Adjustments that do not meet this 
threshold (``non-material adjustments''), may be aggregated and only 
the cost impact of that aggregated bundle would need to be shown in the 
certification as set forth in paragraph (b)(4)(ii). In Sec.  
438.7(b)(4)(iv), we proposed that the actuarial certification include a 
list of all the non-material adjustments used in rate development, but 
that specifics of each non-material adjustment would not need to be 
identified. We noted that as we gain experience in reviewing 
adjustments consistent with these standards and further consult with 
states, we may issue guidance on what we believe to be material and 
non-material adjustments, but until that time, we would expect the 
actuary to exercise reasonable judgment and good faith when 
characterizing or treating an adjustment as material or non-material.
    We received the following comments in response to proposed Sec.  
438.7(b)(4).
    Comment: We received one comment stating that, absent a formal CMS 
definition of materiality, Sec.  438.7(b)(4) should permit materiality 
to be determined by each certifying actuary and documented in the 
certification. For proposed Sec.  438.7(b)(4)(iv), a commenter 
requested clarification on what is meant by ``a list of all non-
material adjustments used in the rate development process'' and 
clarification on the benefit of listing adjustments that were not 
deemed material. The commenter questioned if this was intended to 
address only those adjustments that were included in the development of 
the capitation rates or all of the adjustments that were considered in 
the rate development process.
    Response: As we stated in the proposed rule, at 80 FR 31126, and 
restated above, as we gain experience in reviewing adjustments 
consistent with these standards and further consult with states, we may 
issue guidance on what we believe to be material and non-material 
adjustments. Until that time, we expect the actuary to exercise 
reasonable judgment and good faith when characterizing or treating an 
adjustment as material or non-material. Regarding the commenter's 
question on the intent of Sec.  438.7(b)(4)(iv), the list of all non-
material adjustments encompasses non-material adjustments actually 
applied in the rate development process. The distinction between non-
material and material adjustments and the requirement that both be 
documented in the rate certification permits us, in our review and 
approval of the rate certification, to document changes in the state's 
Medicaid program, knowing that the actuary addressed them and deemed 
them non-material (for example, if a new small benefit was added to the 
contract). Note that we may determine in the review of the rate 
certification that something the actuary deemed non-material is 
actually material and seek to discuss it with the state.
    Comment: One commenter believed that when a state applies an 
efficiency factor to the proposed rate, the state's rate certification 
submission should include documentation supporting the assumptions 
behind the efficiency factor and that they should be determined by

[[Page 27595]]

the actuary to be reasonably achievable, fully transparent, and 
required milestones be disclosed on a prospective basis.
    Response: We concur with the commenter and believe the statement is 
consistent with the final rule.
    After consideration of public comments, we are finalizing Sec.  
438.7(b)(4) as proposed.
    In paragraph (b)(5), we proposed to establish documentation 
standards in the certification for prospective and retrospective risk 
adjustment. In paragraph (b)(5)(i), we proposed that the rate 
certification should include sufficient detail of the prospective risk 
adjustment methodology for our review because the methodology is an 
integral part of the rate development process. To evaluate the 
appropriateness of the prospective risk adjustment methodology, we 
proposed that the following specific pieces of information be included 
in the rate certification: The model selected and data used by the 
state; the method for calculating the relative risk factors and the 
reasonableness and appropriateness of the method in measuring the risk 
of the respective populations; the magnitude of the adjustment on the 
capitation rate for each MCO, PIHP, or PAHP; and an assessment of the 
predictive value of the methodology compared to prior rating periods, 
and any concerns the actuary may have with the risk adjustment process.
    Retrospective risk adjustment methodologies are calculated and 
applied after the rates are certified; however, we proposed in Sec.  
438.7(b)(5)(ii) that the certification must document who is calculating 
the risk adjustment; the timing and frequency of the risk adjustment; 
the model and the data to be used and any adjustments to them; and any 
concerns the actuary may have with the risk adjustment process. For 
either approach to risk adjustment, our proposal required adjustment to 
be budget neutral under Sec.  438.5(b)(6).
    We proposed that use of the risk adjustment model as a method to 
retrospectively increase or decrease the total payments across all 
Medicaid managed care plans based on the overall health status or risk 
of the population would not be permitted. Such retrospective increases 
or decreases in the total payments would not meet the standard in Sec.  
438.5(g) that the risk adjustment methodology be developed in a budget 
neutral manner. We believe that an adjustment applied to the total 
payments across all managed care plans to account for significant 
uncertainty about the health status or risk of a population is an 
acuity adjustment, which is a permissible adjustment under Sec.  
438.5(f), but would need to be documented under paragraph (b)(4) of 
this section regarding adjustments. While retrospective acuity 
adjustments may be permissible, they are intended solely as a mechanism 
to account for differences between assumed and actual health status 
when there is significant uncertainty about the health status or risk 
of a population, such as: (1) New populations coming into the Medicaid 
program; or (2) a Medicaid population that is moving from FFS to 
managed care when enrollment is voluntary and there may be concerns 
about adverse selection. In the latter case, there may be significant 
uncertainty about the health status of which individuals would remain 
in FFS versus move to managed care; although this uncertainty is 
expected to decrease as the program matures.
    We received the following comments in response to proposed Sec.  
438.7(b)(5).
    Comment: We received one comment recommending that CMS not require 
recertification of the capitation rates through submission of revised 
rate certification when capitation rates change (after the base rates 
have been certified) as a result of the application of risk adjustment. 
The commenter contends that recertification on each risk adjustment 
would represent a significant, and costly change from current practice. 
Another commenter believed that requiring recertification would 
represent a significant change from current practice in that the rate 
certification is for the base capitation rates and the documentation of 
risk adjustment certifies that it is being applied on a budget neutral 
basis. Another commenter requested clarification on whether it will now 
be a requirement that the actuary include this as a part of the 
actuarial certification documentation even though risk adjustment can 
be calculated and applied to the certified base rates by the state or 
outside vendors.
    Response: We appreciate the opportunity to clarify these issues. 
First, the state would not need to submit a revised rate certification 
for the capitation rates that have been modified through the risk 
adjustment methodology if the risk adjustment methodology was approved 
in the initial rate certification. The state would need to submit an 
update to the capitation rates under the contract consistent with Sec.  
438.3(c) to ensure that CMS has the appropriate capitation rates for 
purposes of reconciling the CMS-64. That process would not necessarily 
require a formal contract amendment and we encourage states to include 
the payment terms in the contract (as required in Sec.  438.3(c)) as an 
appendix to the contract for ease of updating the information. We will 
finalize Sec.  438.7(b)(5) with a new paragraph (iii) to clarify that a 
new rate certification is not required for the capitation rates to 
which the risk adjustment methodology was applied. Second, Sec.  
438.7(b)(5) requires the rate certification to adequately describe the 
risk adjustment methodology with enough detail in Sec. Sec.  
438.7(b)(5)(i) or 438.7(b)(5)(ii) for CMS to review and approve the 
methodology.
    Comment: We received a few comments on proposed Sec.  438.7(b)(5) 
stating that CMS should review the adequacy of the risk adjustment 
methodology, including a review of information such as the documented 
R-squared value for the proposed methodology. Any state-specific 
adjustments to an established methodology (that is, credibility 
factors) should be thoroughly explained and subject to the transparency 
requirements. Another commenter requested clarification as to whether 
the documentation required for prospective risk adjustment includes the 
magnitude of the adjustment per managed care plan. The commenter stated 
that this information is not available at the same time as the rate 
development report and would delay submission of the rate development 
package if risk score results (not just the methodology) need to be 
completed.
    Response: The risk adjustment methodology, whether prospective or 
retrospective, must be documented in the rate certification submitted 
for our review and approval as specified in Sec.  438.7(b)(5). The 
level of documentation required by the rule includes adjustments to the 
model (see Sec.  438.7(b)(5)(i)(B) and (b)(5)(ii)(B)). In regard to the 
second comment, Sec.  438.7(b)(5)(i)(D) specifies that the magnitude of 
the adjustment on the capitation rate is to be documented per MCO, 
PIHP, or PAHP. We do not understand the commenter's concern that this 
requirement would delay submission of the rate certification. If the 
risk adjustment is applied prospectively, the results, including both 
the methodology and risk scores, should be known prior to the start of 
the contract. If the risk adjustment is applied retrospectively, the 
state would report this along with the changes to the capitation rates.
    Comment: We received one comment requesting clarification on the 
assessment of the predictive value of the risk adjustment methodology 
compared

[[Page 27596]]

to prior rating periods required in proposed Sec.  438.7(b)(5)(i)(E). 
The commenter believed that for most programs, this will be additional 
administrative effort going forward and that this issue may be better 
addressed via reliance upon ASOP No. 45, which specifically covers the 
topic of risk adjustment, and the CMS Ratesetting Checklist AA.5.4 
which indicates use of ``generally accepted diagnosis groupers.''
    Response: In a prospective risk adjustment model--where enrollee 
and/or managed care plan data from a prior year is used--it is 
important to establish how well these models perform. Therefore, we are 
finalizing as proposed the requirement at Sec.  438.7(b)(5)(i)(E) that 
the rate certification include an assessment of the predictive values 
of the methodology compared to prior rating periods.
    Comment: We received one comment on proposed Sec.  
438.7(b)(5)(i)(F) which requests identifying any concerns the actuary 
has with the risk adjustment process. The commenter stated that 
actuaries do not choose or develop the individual risk adjustment 
factors in many of the states in which capitation rates are set. The 
actual derivation, cost weights, etc. are typically considered 
proprietary by either an outside vendor or perhaps even a state. To 
include ``concerns'' from the certifying actuary that does not have 
that detailed knowledge about the risk adjustment process or a way to 
validate it without undue cost burden is a challenge to request. The 
commenter suggested that Sec.  438.7(b)(5)(i)(F) be revised to ``Where 
the certifying actuary is responsible for the development of the risk 
adjustment process, provide any concerns the actuary has with the risk 
adjustment process.''
    Response: The actuary does not necessarily have to evaluate the 
risk adjustment methodology under this final rule, but if the actuary 
does, then the actuary will need to specify if there is a concern. 
However, we note that it would be of concern to us if the risk 
adjustment is conducted by someone not qualified to do so.
    After consideration of public comments, we are adding a new 
paragraph (iii) to Sec.  438.7(b)(5) to clarify that a revised rate 
certification is not required for capitation rates that change due to 
application of an approved risk adjustment methodology. Consistent with 
other technical corrections to Sec.  438.7 discussed above, the phrase 
``sufficient detail'' was struck and replaced with ``enough detail.''
    In Sec.  438.7(b)(6), we proposed that the rate certification 
include a description of any of the special contract provisions related 
to payment in Sec.  438.6, such as risk sharing mechanisms and 
incentive or withhold arrangements. We did not receive comments on 
Sec.  438.7(b)(6) and are finalizing that provision as proposed.
    In paragraph (c), we proposed the rate certification standards for 
rates paid under risk contracts. In paragraph (c)(1), we acknowledge 
that states may pay different capitation rates to different managed 
care plans; for example, some states already account for differences in 
final capitation rates paid to contracted managed care plans through 
risk adjustment. States that choose to pay different rates to managed 
care plans (for factors such as differing administrative assumptions, 
service area adjustments or other non-risk adjustment methodologies) 
will need to provide documentation for the different assumptions used 
in the development of each of the individual rates paid to each plan. 
While such variations are permissible, we reminded states as reflected 
and strengthened in this final rule, that all payment rates must be 
actuarially sound under existing law.
    We received the following comments on Sec.  438.7(c)(1).
    Comment: We received several comments on the certification of the 
final rate paid as proposed in Sec.  438.7(c)(1). A few commenters 
requested clarification on whether a capitation rate is considered to 
be ``independently developed'' if it is a rate that is selected from 
within an actuarially sound rate range that may be used to select or 
negotiate rates for multiple managed care plans. One commenter 
requested clarification on whether CMS will require actuarial 
certification of both the rate range(s) used in the RFP and a second 
certification for the actual rate. Another commenter requested 
clarification on whether CMS requires an explanation of why a 
particular rate within the range is selected, even if the selection is 
based on negotiation with the managed care plan. Under Sec.  
438.7(c)(1), the actuary is required to certify the final capitation 
rate paid under each risk contract, not the average rate. The entire 
development of the capitation rates does not necessarily need to be 
different for each managed care plan operating in the state, as some 
components of rate development may be the same for all managed care 
plans in a given managed care program.
    Response: We clarify here that the actuary must certify to 
actuarially sound capitation rates per rate cell, but the actuary may 
provide a rate range to the state for purposes of contract negotiation. 
This is consistent with and permissible under the ``independently 
developed'' requirement in Sec.  438.7(c)(1). The rate certification 
submitted under Sec.  438.7(a) is to the actuarially sound capitation 
rates per rate cell; this final rule does not require development or 
submission to CMS of a rate certification for a rate range that may be 
used in a RFP to contract with managed care plans. The rate 
certification required under Sec.  438.7 does not need to include an 
explanation of how the capitation rate was selected from a rate range 
used during contract negotiations because the rate certification must 
address the specific capitation rate assigned to each rate cell.
    Comment: We received one comment requesting clarification as to 
what may be conflicting requirements in Sec. Sec.  438.5(b)(5), 
438.7(c)(1) and ASOP No. 49. The commenter requested that CMS confirm 
that the application of the MLR results for an individual MCO, PIHP, or 
PAHP--as required by Sec.  438.5(b)(5)--to an average capitation rate 
for a specific population in a specific geographical service area would 
not trigger the requirement under Sec.  438.7(c)(1) that rates must be 
``independently developed.'' The commenter also stated that in addition 
to the MLR, the actuary may also apply other managed care plan specific 
factors to a single, average capitation rate established for a specific 
population in a specific geographic area, such as risk adjustment and 
components of the rate that are competitively bid (such as 
administrative costs). The commenter requested that CMS confirm that 
the application of these factors to an average rate would not trigger 
the requirement under Sec.  438.7(c)(1) that rates be independently 
developed for each managed care plan.
    Response: We do not find the commenter's scenarios to be in 
conflict with Sec.  438.7(c)(1). Section 438.7(c)(1) requires the 
actuary to certify the final rate paid under each risk contract 
regardless of the MLR results. Under Sec.  438.5(b)(5), the actuary 
must consider the managed care plan's past MLR when setting the final 
capitation rates paid under each risk contract. The actuary must 
consider whether or not Sec.  438.7(c)(1) requires them to 
independently develop capitation rates for each MCO, PIHP, or PAHP. 
This does not mean that the entire development of the rates necessarily 
needs to be different for each MCO, PIHP, or PAHP, as some components 
of rate development may be the same for all MCOs, PIHPs, or PAHPs in a 
given program. The actuary may consider whether or not an average rate 
would be appropriate for all MCOs, PIHPs, or

[[Page 27597]]

PAHPs in a given program, so long as the rate certification is provided 
for each final capitation rate.
    After consideration of public comment, we are finalizing the 
introductory text in Sec.  438.7(c) as proposed with two technical 
modifications: (1) To insert ``per rate cell'' preceding ``under each 
risk contract''; and (2) to insert the word ``capitation'' after 
``specific.'' We are finalizing Sec.  438.7(c)(1) as proposed by 
replacing ``the'' following the phrase ``so long as'' with the word 
``each''; and to insert the word ``capitation'' before ``rate.''
    In Sec.  438.7(c)(2), we proposed to establish parameters for 
retroactive adjustments to capitation rates paid under the risk 
contract. Specifically, we proposed that the state submit a revised 
rate certification (and contract amendment) that describes the specific 
rationale, data, assumptions, and methodologies of the adjustment in 
sufficient detail to understand and evaluate the proffered retroactive 
adjustments to the payment rate. All such adjustments are also subject 
to federal timely filing standards for FFP.
    Comment: One comment recommended that if the state determines a 
retroactive rate adjustment is necessary, CMS should require the state 
to provide supporting information to justify the need for a rate 
adjustment.
    Response: That is the requirement at Sec.  438.7(c)(2).
    After consideration of public comments, we are finalizing Sec.  
438.7(c)(2) as proposed with a technical correction to insert ``claim'' 
so that the regulatory reference is to ``Federal timely claim filing 
requirements'' and to insert ``enough'' in place of ``sufficient.'' As 
discussed in section I.B.3.b of this final rule, we will finalize Sec.  
438.7(c) with a new paragraph (3) to reflect the state's ability to 
modify the certified capitation rate per rate within a 1.5 percent 
range without submitting a revised rate certification. This provision 
also specifies that the payment term under the contract must updated as 
required under Sec.  438.3(c).
    In paragraph (d), we proposed to require states to include 
additional information in the rate certification if pertinent to our 
approval of the contract rates and to identify whether that additional 
information, which may supplement the rate certification, is proffered 
by the state, the actuary, or another party. This proposal was to set 
forth our expectations and set parameters for consistent and 
transparent documentation of the rate setting process so that we 
conduct more efficient reviews of the rate certification submissions 
and to expedite the approval process.
    We received the following comments on proposed Sec.  438.7(d).
    Comment: We received one comment on proposed 438.7(d) requesting 
additional detail on what additional information CMS could reasonably 
require, given that the documentation requirements in Sec.  438.7 as a 
whole would appear to cover all information necessary for approval.
    Response: Section 438.7(d) permits CMS to request additional 
information, such as data books, rate setting information from past 
rating periods, or other relevant information, to inform the review of 
the rate certification and make the determination that the capitation 
rates are actuarially sound.
    After consideration of public comments, we are finalizing Sec.  
438.7(d) as proposed.
    We proposed to remove the standard currently at Sec.  
438.6(c)(4)(iii) that states document the projected expenditures under 
the proposed contract compared to the prior year's contract, or with 
FFS if the managed care program is new. We do not believe that this 
information is integral to the review of the rate certification or 
contract; further, such information can be reasonably calculated by CMS 
if necessary. We did not receive comments on this proposal and will 
finalize this rule without the requirement that states document the 
projected expenditures under the contract compared with the prior 
year's contract or with FFS.
4. Other Payment and Accountability Improvements
a. Prohibition of Additional Payments for Services Covered Under MCO, 
PIHP, or PAHP Contracts (Sec.  438.60)
    We proposed a new heading for Sec.  438.60 and to make minor 
revisions to the regulatory text to clarify the intent of the 
prohibition of additional payments to network providers that are 
contracted with an MCO, PIHP or PAHP. The original heading of Sec.  
438.60 was ``Limit on payments to other providers;'' we believe that 
heading was potentially ambiguous or confusing when paired with the 
regulatory text as it could be read to treat an MCO, PIHP, or PAHP as a 
provider. We proposed to revise the section heading as ``Prohibition of 
additional payments for services covered under MCO, PIHP, or PAHP 
contracts'' to make clear that the capitation payments are to be 
inclusive of all service and associated administrative costs under such 
contracts. In addition, we proposed to refine overly broad references 
to Title XIX of the Act and this title of the CFR to clarify that such 
payments are permitted only when statute and regulation specifically 
stipulate that the state make those payments directly to a provider. We 
explained that the exception to this standard has always been limited 
to cases where other law (statutory or regulatory) explicitly directs 
the state to make the additional payment to the health care provider 
and propose to strengthen the language accordingly. Finally, we 
proposed to update the cross-reference for GME payments from its 
current location at Sec.  438.6(c)(5)(v) to Sec.  438.6(b)(4) to 
reflect the proposed restructuring of Sec.  438.6.
    We received the following comments in response to our proposal to 
revise Sec.  438.60.
    Comment: Several commenters objected to the requirement at Sec.  
438.6(b)(4) that if the state directly makes payments to network 
providers for graduate medical education (GME) costs under an approved 
State plan, the actuarially sound capitation payments must be adjusted 
to account for those GME payments. A cross-reference to Sec.  
438.6(b)(4) is in Sec.  438.60, which conditioned the state's direct 
payment of GME payments to providers covered under the managed care 
contract on compliance with the adjustment to capitation rates to 
account for such payments.
    Response: Section 438.6(b)(4) pertaining to the adjustment to the 
capitation rates to account for GME payments was redesignated in the 
proposed rule from Sec.  438.6(c)(5)(v) and is linked to the provision 
in Sec.  438.60 that permits states to make GME payments directly to 
network providers. Based on the comments received, it is clear that 
states were not consistently applying this provision. We agree that for 
states that make direct GME payments to providers, it is not necessary 
for the state for develop actuarially sound capitation rates prior to 
excluding GME payments or to include GME payments that are made 
directly by the state to eligible providers in the development of the 
capitation rates. Therefore, we are finalizing Sec.  438.60 without the 
cross-reference to Sec.  438.6(b)(4) and have deleted that provision 
from Sec.  438.6(b). State payment of GME directly to network providers 
is an exception to the general prohibition in Sec.  438.60 for state 
payments to network providers for services covered under the MCO, PIHP, 
or PAHP contract. In addition, we will clarify at Sec.  438.60 that GME 
payments made directly by the state to eligible network providers must 
be consistent with the state plan.

[[Page 27598]]

    Comment: We received several comments on the intersection between 
Sec.  438.60 and supplemental or pass-through payments to network 
providers.
    Response: The discussion of supplemental or pass-through payments 
is provided in section I.B.3.d of this rule that involves special 
contract provisions related to payment and proposed Sec.  438.6(c).
    After consideration of the public comments, we are finalizing Sec.  
438.60 with two modifications: (1) without the cross-reference to Sec.  
438.6(b)(4) or the requirement to adjust capitation payments when the 
state directly makes GME payments to eligible network providers; and 
(2) with the addition of a requirement that the state payment of GME be 
consistent with the state plan.
b. Subcontractual Relationships and Delegation (Sec.  438.230)
    We proposed to replace the current standards in Sec.  438.230 with 
clearer standards for MCOs, PIHPs, or PAHPs that enter into 
subcontractual relationships and delegate responsibilities under the 
contract with the state. These proposed standards were modeled on the 
MA standards relating to MA organization relationships with first tier, 
downstream, and related entities at Sec.  422.504(i).
    In paragraph (a), we proposed to more clearly state when Sec.  
438.230 would apply by adding language specifying that the standards of 
this section would apply to all contracts and written arrangements that 
a MCO, PIHP, or PAHP has with any individual or entity that relates 
directly or indirectly to the performance of the MCO's, PIHP's, or 
PAHP's obligations under the contract with the state.
    In new paragraph (b)(1), we proposed that regardless of any 
relationship that a MCO, PIHP, or PAHP may have, it alone is 
accountable for complying with all terms of the contract with the 
state. While this is not a new standard, we explained that this 
revision to the text more clearly stated our intent. We proposed in new 
paragraph (b)(2) to specify that all contracts and written arrangements 
comply with the provisions of paragraph (c).
    Existing paragraphs (b)(2)(i) (requiring the contract to specify 
the delegated activities, obligations, and responsibilities) and 
(b)(2)(ii) (providing for revocation of any delegation) would be 
redesignated as (c)(1)(i) and (c)(1)(iii) but would otherwise remain 
substantively the same with revisions for clarity. In paragraph 
(c)(1)(ii), we proposed to add that the individual or entity accepting 
the delegation agrees to perform the activities in compliance with the 
MCO's, PIHP's, or PAHP's contract with the state. In paragraph (c)(2), 
we proposed a general standard that the entity or individual performing 
the delegated activities must comply with all applicable Medicaid laws, 
regulations, subregulatory guidance, and contract provisions. Lastly, 
in paragraphs (c)(3)(i) through (iv), we proposed that the entity or 
individual performing the delegated activities must agree to grant the 
state, CMS, HHS OIG, or the Comptroller General the right to audit, 
evaluate, and inspect any books, contracts, computer or other 
electronic systems that pertain to services performed or determinations 
of amounts payable; make available for audit, evaluation, or 
inspection, its premises, physical facilities, equipment and records; 
preserve the rights under (c)(3)(i) for 10 years from completion; and 
grant the state, CMS, HHS OIG, or the Comptroller General the right to 
audit, evaluate, and inspect at any time if the reasonable possibility 
of fraud is determined to exist by any of these entities.
    We received the following comments in response to our proposal to 
revise Sec.  438.230.
    Comment: Many commenters supported proposed Sec.  438.230 and 
stated that the provisions will strengthen program integrity efforts 
for subcontractors of managed care plans. A few commenters recommended 
additional clarification at Sec.  438.230(a) and (b). A few commenters 
recommended that CMS add language to clarify that such requirements 
only apply to applicable services and activities that are delegated to 
meet the obligations under the managed care plan's contract with the 
state. One commenter recommended that CMS clarify whether the intent 
and scope of Sec.  438.230(a) and (b) are related to program integrity 
standards or specific vendor IT requirements. A few commenters 
recommended that CMS either define ``relates indirectly'' or remove the 
language from the regulatory text, as it is unclear as written. One 
commenter stated that the language ``relates indirectly to the 
performance'' indicates that cafeteria vendors or real estate 
contractors would also need to meet the requirements specified at Sec.  
438.230.
    Response: We thank commenters for their support and agree that the 
provisions at Sec.  438.230 will strengthen program integrity efforts 
for subcontractors of managed care plans. Section 438.230 applies to 
all contracts and written agreements between managed care plans and 
individuals or entities that directly or indirectly relate to the 
performance of the managed care plan's obligations under its contract 
with the state. In other words, if managed care plans subcontract or 
delegate any of their obligations, services, or activities under their 
contract with the state, Sec.  438.230 applies. In reviewing these 
public comments and considering a managed care plan's subcontracted or 
delegated obligations, services, or activities, we realized that PCCM 
entities should have been included throughout Sec.  438.230, as PCCM 
entities may contract with a fiscal intermediary or other 
administrative organization to conduct requirements under their 
contract with the state. Therefore, we will modify the regulatory text 
throughout Sec.  438.230 to add and include PCCM entities in this 
regulation. We note that it is unlikely that cafeteria vendors or real 
estate contractors would directly or indirectly relate to the 
performance of the managed care plan's obligations under its contract 
with the state. We therefore decline to revise the proposed regulatory 
language, as we believe our intent is clear that the focus is on the 
obligations of the managed care plan under the contract with the state 
and when those obligations are subcontracted or delegated. We also 
clarify for the commenter that the intent and scope of Sec.  438.230(a) 
and (b) are related to program integrity standards and not specific 
vendor IT requirements; however, we clarify that this regulation would 
apply to all IT subcontractors if they are performing work that is 
governed by the managed care plan's contract with the state or these 
regulations.
    Comment: A few commenters recommended that CMS impose requirements 
for related entities who share common ownership, board membership, or 
subsidiary status. One commenter recommended that CMS clarify whether 
states need to review ownership and control disclosures for all 
subcontractors of managed care plans, or only those subcontractors that 
perform services and activities applicable to the requirements under 
the contract with the state. One commenter recommended that CMS exempt 
managed care plans' network providers, as these requirements are 
unworkable for network providers. One commenter recommended that CMS 
exempt small vendors who are performing services and activities for a 
minimal amount of money.
    Response: We decline to add specific requirements for ownership and 
control disclosures at Sec.  438.230(a) and (b), as these requirements 
are found at

[[Page 27599]]

Sec.  438.602(c) Sec.  438.608(c) of this part. We clarify for 
commenters that states must review ownership and control disclosures 
for all subcontractors of managed care plans that perform services and 
activities applicable to the requirements under the contract with the 
state. We decline to add an exemption for small vendors who are 
performing services and activities on behalf of the managed care plan 
for a minimal amount of money, as these recommendations are 
inconsistent with our general approach to strengthen program integrity 
efforts for all subcontractors of managed care plans. It is critical 
for CMS and states to continue strengthening program integrity 
activities that protect beneficiaries and promote better stewardship of 
state and federal funds and resources.
    However, in light of public comments received on this provision and 
others, we believe it is important to distinguish network providers 
from subcontractors as the responsibilities on both, as well as the 
responsibilities on managed care plans in relation to both, are 
different throughout this part. Therefore, we will finalize this rule 
with a new definition for ``subcontractor'' in Sec.  438.2 as an 
individual or entity that has a contract with an MCO, PIHP, PAHP, or 
PCCM entity that relates directly or indirectly to the performance of 
the MCO's, PIHP's, PAHP's, or PCCM entity's obligations under its 
contract with the State. A network provider is not a subcontractor by 
virtue of the network provider agreement. Similarly, we will finalize 
the definition of a ``network provider'' at Sec.  438.2 to clarify that 
a network provider is not a subcontractor when acting as a network 
provider; the network provider agreement with the managed care plan 
does not create a subcontractor relationship for purposes of this rule. 
Since the definition of a subcontractor includes ``an individual or 
entity'' we will finalize Sec.  438.230(a), (b)(1) and (2), (c)(1) 
introductory text, (c)(1)(ii) and (iii), (c)(2), (c)(3) introductory 
text, and (c)(3)(i) through (iv) with ``subcontractor'' in place of 
``individual or entity.''
    Comment: A few commenters recommended that CMS fix the 
typographical error at Sec.  438.230(b)(2) to include commas between 
``MCO's PIHP's or PAHP's.''
    Response: We are modifying the regulatory text at Sec.  
438.230(b)(2) to include commas in the referenced phrase.
    Comment: A few commenters recommended that CMS add standards at 
Sec.  438.230(c)(1) to require managed care plans to submit a list of 
all subcontractors to the state for review. One commenter recommended 
that CMS define ``not performed satisfactorily'' at Sec.  
438.230(c)(1)(iii).
    Response: We decline to add standards at Sec.  438.230(c)(1) to 
require managed care plans to submit a list of all subcontractors to 
the state for review. Consistent with the requirements at Sec.  
438.230, states and managed care plans must ensure that the contract 
between them addresses certain requirements that must be present in any 
contract or written arrangement between the plan and the plan's 
subcontractor or delegate. It would not be appropriate to broaden this 
requirement to require, as a matter of federal law, the managed care 
plan to seek state approval of all subcontracting or delegation 
arrangements. States that wish to have this additional level of 
information and involvement in the arrangements the managed care plan 
has with subcontractors or delegates may impose such requirements 
consistent with state law. We also decline to define ``not performed 
satisfactorily'' at Sec.  438.230(c)(1)(iii), as this standard should 
be established and defined under the contract between the state and 
managed care plan.
    Comment: Several commenters recommended that CMS revise the 
requirements at Sec.  438.230(c)(2). A few commenters recommended that 
CMS add the term ``relevant'' before ``laws and regulations.'' A few 
commenters recommended that CMS clarify that the term ``applicable'' 
only applies to ``laws and regulations.'' A few commenters recommended 
that CMS add the phrase ``to the extent applicable'' before ``laws and 
regulations.'' A few commenters recommended that CMS remove 
``subregulatory guidance'' or clarify that only ``relevant 
subregulatory guidance'' applies.
    Response: We are modifying the regulatory text at Sec.  
438.230(c)(2) to clarify for commenters that the individual or entity 
agrees to comply with all applicable Medicaid laws and regulations, 
including applicable subregulatory guidance and contract provisions. We 
believe this modification will clarify our intent for subcontractors.
    Comment: Several commenters recommended that CMS revise the 
requirements at Sec.  438.230(c)(3). One commenter recommended that CMS 
add oversight requirements for states. A few commenters recommended 
that CMS define ``reasonable possibility of fraud'' at Sec.  
438.230(c)(3)(i). One commenter recommended that CMS remove 
``reasonable possibility of fraud'' as all contracts already contain 
audit rights for state and federal government officials. One commenter 
recommended that CMS add ``or similar risk'' after ``reasonable 
possibility of fraud'' at Sec.  438.230(c)(3)(i) to be consistent with 
Sec.  438.230(c)(3)(iv). A few commenters recommended that CMS add 
``waste or abuse'' after ``reasonable possibility of fraud'' to be 
consistent with industry standards. One commenter recommended that CMS 
clarify that Sec.  438.230(c)(3) only applies to delegated services and 
activities under the managed care plan's contract with the state. 
Finally, several commenters recommended that CMS revise the right to 
audit requirement and timeframe of 10 years at Sec.  438.230(c)(3)(iii) 
to be consistent with the recordkeeping requirement and timeframe of 6 
years at Sec.  438.3(v). A few commenters recommended that the right to 
audit requirement and timeframe of 10 years be reduced to 5 years to 
relieve recordkeeping burden.
    Response: We clarify for commenters that Sec.  438.230(c) applies 
to all contracts and written agreements between managed care plans and 
individuals or entities that directly or indirectly relate to the 
performance of the managed care plan's obligations under its contract 
with the state. In other words, if managed care plans subcontract or 
delegate any of their obligations, services, or activities under their 
contract with the state, Sec.  438.230(a) through (c) applies. We 
appreciate the recommendation to add oversight requirements for states, 
but note that such requirements are found throughout part 438, and 
specifically at Sec.  438.3 for standard contract requirements and 
subpart H of this part for program integrity safeguards. For 
consistency with the inspection and audit provisions at Sec.  438.3(h), 
we have deleted from Sec.  438.230(c)(3)(i) the language conditioning 
the inspection or audit rights of subcontractors to instances where the 
reasonable possibility of fraud exists. Due to changes in Sec.  
438.3(u) relating to record keeping requirements to change the 
retention period from 6 years to 10 years, we are retaining the 10 year 
audit period in paragraph (c)(3)(iii), which is consistent with Sec.  
438.3(h) as finalized in this rule.
    After consideration of the public comments, we are modifying the 
regulatory text at Sec.  438.230(b)(2) to include commas as necessary. 
As we will finalize this rule with a definition for ``subcontractor,'' 
that term replaces references to ``individual or entity'' throughout 
Sec.  438.230. We are also modifying the regulatory text at Sec.  
438.230(c)(2) to clarify for commenters that the subcontractor agrees 
to comply

[[Page 27600]]

with all applicable Medicaid laws and regulations, including applicable 
sub-regulatory guidance and contract provisions. For consistency with 
the inspection and audit provisions at Sec.  438.3(h), we are deleting 
the regulatory language conditioning the inspection or audit rights of 
subcontractors to instances where the reasonable possibility of fraud 
exists from Sec.  438.230(c)(3)(i). To clarify the contract that is 
referenced in Sec.  438.230(c)(3)(i), we have inserted ``MCO's, PIHP's, 
or PAHP's'' before ``contract.'' In addition, we will finalize 
paragraphs (c)(3)(i) and (c)(3)(ii) to include the same list of items 
that are subject to audit, evaluation, and inspection. Finally, we will 
add and include PCCM entities throughout Sec.  438.230 as they may 
contract with a fiscal intermediary or other administrative 
organization to conduct requirements under the contract with the state. 
We are finalizing all other sections as proposed.
c. Program Integrity (Sec. Sec.  438.600, 438.602, 438.604, 438.606, 
438.608, and 438.610)
    We proposed several changes to the program integrity provisions in 
subpart H that were intended to address two types of program integrity 
risks that were of particular concern: fraud committed by Medicaid 
managed care plans and fraud by network providers. The provisions of 
the proposed rule were intended to address both of these types of risk, 
as well as tighten standards for MCO, PIHP, PAHP, PCCM, and PCCM entity 
submission of certified data, information, and documentation that is 
critical to program integrity oversight by state and federal agencies. 
At 80 FR 31127-31128, we discussed a number of laws that passed since 
2002 that impacted program integrity as well as relevant OIG reports 
that identified potential program integrity vulnerabilities in Medicaid 
managed care programs. We proposed to modify the title of subpart H to 
``Additional Program Integrity Safeguards'' from the current title 
``Certifications and Program Integrity'' to recognize that various 
program integrity standards, such as those relating to audited 
financial data, MLR, and subcontractual relationships, among others, 
were proposed to be added throughout this part. In addition, we 
proposed to add entirely new provisions and amend existing provisions 
to address program integrity risks that are addressed in detail below.
(1) Statutory Basis (Sec.  438.600)
    In Sec.  438.600, we proposed to add to the existing list of 
statutory provisions related to program integrity that support our 
proposed changes to this subpart. Our proposal included the following 
statutory provisions: sections 1128, 1128J(d), 1902(a)(4), 1902(a)(19), 
1902(a)(27), 1902(a)(68), 1902(a)(77), 1902(a)(80), 1902(kk)(7), 
1903(i), 1903(m), and 1932(d)(1) of the Act. In the description of 
section 1932(d)(1) of the Act in Sec.  438.600, we proposed to remove 
the term ``excluded'' and replace it with ``debarred'' to reflect the 
statutory standard. As a general matter, we relied on section 
1902(a)(4) of the Act when standards in this subpart were proposed to 
extend beyond MCOs to PIHPs, PAHPs, PCCMs, and PCCM entities.
    We received the following comments in response to our proposal to 
revise Sec.  438.600.
    Comment: A few commenters objected to the deletion of the basic 
rule in the existing Sec.  438.602 that would require MCO, PIHP, PAHP 
and PCCM compliance with the certification, program integrity and 
prohibited affiliation requirements of this subpart as a condition for 
payment as the proposed rule modified that section to include state 
responsibilities for program integrity. A commenter also requested that 
the general rule be a condition for state and federal funds.
    Response: We appreciate commenters raising this point as the 
deletion of the general rule was not intended. Therefore, we have 
modified the title and text of Sec.  438.600 to include both the 
statutory basis and basic rule, as was provided under Sec.  438.602 
prior to the proposed rule, with the addition of PCCM entities and 
specific references to Sec. Sec.  438.604, 438.606, 438.608 and 
438.610. The statutory basis has been redesignated as paragraph (a) 
with each statutory provision in numerical order and the basic rule is 
designated as paragraph (b). As part 438 sets forth the requirements 
for the expenditure of federal funds for a Medicaid managed care 
program, we decline to extend the basic rule to be a condition on the 
expenditure of state funds under the contract.
    Comment: One commenter requested that CMS provide a definition of 
the term ``debarred'' as it appears in Sec.  438.600(a)(l2).
    Response: The term ``debarred'' is used in statute at section 
1932(d)(1) of the Act and has been and continues to be used in Sec.  
438.610. It is one means by which an individual or entity is excluded 
from participation in the Medicaid program. We do not believe a 
separate regulatory definition is necessary for the term.
    After consideration of the public comments, we are finalizing Sec.  
438.600 with a statement of the basic rule and have redesignated the 
paragraphs accordingly. We have also made a technical correction to 
Sec.  438.600(a)(6) to specify that section 1902(a)(68) of the Act 
applies to entities that receive or make annual payments of at least $5 
million for consistency with the statutory language, as the proposed 
rule only specified entities that receive such amounts on an annual 
basis.
(2) State Responsibilities (Sec.  438.602)
    We proposed to replace Sec.  438.602 in its entirety. The intent of 
the revisions to Sec.  438.602 was to contain all state 
responsibilities associated with program integrity in one section. 
Proposed paragraph (a) set forth the state's monitoring standards for 
contractor compliance with provisions in this subpart and Sec.  438.230 
(subcontractual relationships and delegation) and Sec.  438.808 
(excluded entities). We did not receive comments on the proposed 
revisions to Sec.  438.602(a) and will finalize that provision as 
proposed.
    In Sec.  438.602(b), we proposed that states must enroll all 
network providers of MCOs, PIHPs, and PAHPs that are not otherwise 
enrolled with the state to provide services to FFS Medicaid 
beneficiaries. Such enrollment would include all applicable screening 
and disclosure standards under part 455, subparts B and E and ensure 
that all providers that order, refer or furnish services under the 
state plan or waiver are appropriately screened and enrolled. We also 
proposed that this standard would apply to PCCMs and PCCM entities, to 
the extent that the PCCM is not otherwise enrolled with the state to 
provide services to FFS Medicaid beneficiaries. In addition, we 
provided that the proposed extension of the screening and enrollment 
requirement to network providers would not obligate the network 
provider to also render services to FFS beneficiaries.
    We requested comment on this approach; in particular, we sought 
feedback on any barriers to rapid network development that this 
approach might create by limiting the ability of MCOs, PIHPs, or PAHPs 
to contract with providers until the results of the state's screening 
and enrollment process are complete. We also explained that this 
proposal did not alter the MCO's, PIHP's, or PAHP's responsibility 
under Sec.  438.214(c) to operate a provider selection process that 
does not discriminate against providers that serve high-risk 
populations or that specialize in costly treatments or the state's 
responsibility to monitor the

[[Page 27601]]

implementation of provider selection policies in Sec.  438.214(a).
    We received the following comments in response to our proposal at 
Sec.  438.602(b).
    Comment: Several commenters requested clarification on Sec.  
438.602(b) that would extend the screening and enrollment disclosures 
of part 455, subparts B and E to network providers that order, refer or 
furnish services covered under the managed care contract. Many 
commenters cited the administrative burden for network providers to 
complete the enrollment process as applied to FFS providers, the 
administrative and financial burden on the state to conduct the 
process, and potential adverse impacts on network development. Some 
commenters suggested that imposing this requirement would deter 
provider participation in managed care networks. Commenters also cited 
that managed care plans have provider credentialing processes in their 
contracts and such processes should be used rather than requiring 
network providers to enroll with the State Medicaid agency. A number of 
commenters requested clarification as to the meaning of ``enrollment'' 
in this context and how network providers attest that they are 
participating in the Medicaid program if they do not sign a similar 
agreement with the state.
    In light of these concerns, some commenters requested that CMS 
remove this provision altogether while others requested clarification 
in the final rule that states would be permitted to delegate the 
screening and enrollment processes to managed care plans or another 
third party. Other commenters suggested the imposition of timeframes 
for the state to complete the screening and enrollment process to 
mitigate delays in network development. Another suggestion to mitigate 
delays in network development was to permit managed care plans to enter 
into provisional provider agreements pending the outcome of the 
screening and enrollment process. If a provider failed the screen, the 
managed care plan would be obligated to terminate the provider 
agreement immediately or within 30 days and provide notice to impacted 
enrollees. Some commenters suggested that the screening and enrollment 
provisions only apply to new providers that negotiate provider 
agreements with managed care plans after this provision would become 
effective.
    Other commenters were supportive of the provision as a way to 
reduce administrative costs by centralizing the screening, enrollment, 
and revalidation of network provider eligibility but encouraged CMS to 
provide guidance on how the state could reduce administrative and 
financial burden. Some commenters requested that CMS require states to 
share a list of screened providers with the managed care plans on at a 
least a monthly basis. Many commenters questioned the date that states 
would have to be in compliance with the screening and enrollment 
provision for network providers.
    Response: After reviewing the comments received on Sec.  
438.602(b), it may be helpful to clarify the meaning of terms used in 
this provision in relation to similar activities elsewhere in this 
part. First, screening is governed by 42 CFR part 455, subparts B and 
E, which requires that Medicaid providers that order, refer or provide 
services under the state plan undergo certain screening procedures 
according to the applicable risk level for their provider type. In 
addition, providers must disclose information on ownership and control. 
The verification of a provider's licensure under these screening 
requirements overlaps with the credentialing standards in Sec.  438.214 
discussed below. Generally speaking, as the screening process is tied 
to enrollment, Sec.  455.414 requires states to revalidate the 
enrollment of providers at least every 5 years.
    Second, the credentialing process involves the activities taken by 
the state or the managed care plan to verify the education, training, 
liability record, and practice history of providers. This step 
represents the level of scrutiny necessary to ensure that the provider 
is qualified to perform the services that they seek to be paid to 
perform. There is undoubtedly some overlap between the screening and 
credentialing processes. Section 438.214 requires the managed care plan 
to follow the state's credentialing and recredentialing policies. Under 
managed care programs, managed care plans primarily conduct the 
credentialing process as part of executing network provider agreements 
with providers to become part of the managed care plan's network.
    Finally, the screening, disclosures, and credentialing processes 
described above are the precursor to a provider being ``enrolled'' as a 
Medicaid provider with the State Medicaid agency. Under FFS programs, 
upon enrollment, the provider is loaded into the claim adjudication 
system as an approved provider and able to receive payment through 
Electronic Funds Transfer (EFT). We recognize that the proposed rule 
could have been clearer in describing what ``enrollment'' means for 
network providers; however, Sec.  438.602(b) makes clear that the 
``enrollment'' of network providers will not obligate those providers 
to participate in the FFS delivery system. Section 1902(a)(27) of the 
Act requires the state plan to provide for agreements with every person 
or institution providing services under the State plan under which such 
person or institution agrees to keep such records as are necessary 
fully to disclose the extent of the services provided under the State 
plan, and to furnish the State agency or the Secretary with such 
information, regarding any payments claimed by such person or 
institution for providing services under the State plan. Execution of 
the provider agreement with the state and satisfaction of the 
applicable screening requirements results in the provider being 
enrolled as required under 42 CFR part 455. In the regulations 
implementing a provision in section 6402 of the Affordable Care Act, 
requiring inclusion of a National Provider Identifier (NPI) on all 
applications to enroll in Medicare or Medicaid, we noted that there is 
no Federally required enrollment application, although all Medicaid 
providers are required to enter into a provider agreement with the 
State as a condition of participating in the program under section 
1902(a)(27) of the Act. See 77 FR 25284, 25285 (April 27, 2012). 
Accordingly, CMS interpreted the statutory reference to an ``enrollment 
application'' to refer to the provider agreement with the state in the 
Medicaid context. To streamline the execution of the provider 
agreements required for enrollment of network providers, states may, if 
they wish, establish a separate category of provider agreement just for 
network providers, but we note that the required screening must still 
be conducted for such providers. In addition, managed care plans may 
make the state's provider agreement form available to their network 
providers to expedite the process. We reiterate that the network 
provider's execution of the provider agreement with the state does not 
obligate that provider to participate in the FFS delivery system.
    We recognize the changes in administrative procedures and resources 
that may be necessary to carry out the screening and enrollment of 
network providers but believe that the additional burden imposed by 
such changes is outweighed by the benefit of the additional safeguards 
these activities bring to ensure the quality of and access to care for 
Medicaid beneficiaries, as well as to support effective stewardship of 
public resources. We also note that a

[[Page 27602]]

number of states already conduct these activities in relation to 
network providers. In addition, we would anticipate that a significant 
number of current network providers will not need to be screened due to 
existing participation in Medicaid or Medicare FFS (because states, per 
existing regulation, can rely on Medicare screening for Medicaid 
purposes).
    We acknowledge here that states may require a third party, such as 
contracted managed care plans or a fiscal intermediary, to conduct the 
functions in Sec.  438.602(b) but we do so with some cautionary 
statements. We recognize existing arrangements in many states that 
extended the provisions of part 455, subparts B and E to network 
providers before this final rule, as well as the desire of other 
states, that have not already extended these requirements to network 
providers, to rely on their contracted managed care plans or a fiscal 
intermediary to facilitate compliance with these provisions of the 
final rule. We are concerned about quality control, consistency among 
the managed care plans or a fiscal intermediary in conducting these 
activities, and duplicative efforts with respect to network providers 
that participate in several managed care plans. We are also concerned 
about the ability of managed care plans or a fiscal intermediary to 
conduct all of the functions required in subpart E of 42 CFR part 455, 
including on-site visits and fingerprint-based criminal background 
checks for high-risk providers. As with any state function that is 
contracted out for performance, the state must maintain oversight of 
the activity. Some state functions, such as entering into provider 
agreements under Sec.  431.107, cannot be contracted out for 
performance. The state is not required to contract with a third party 
for the activities in Sec.  438.602(b).
    To mitigate concerns about delays in network development, we are 
adding a new paragraph (b)(2) that the MCO, PIHP, or PAHP may execute 
network provider agreements pending the outcome of the screening 
process of up to 120 days, but upon notification from the state that a 
provider's enrollment has been denied or terminated, or the expiration 
of the one 120 day period without enrollment of the provider, the 
managed care plan must terminate such network provider immediately and 
notify affected enrollees that the provider is no longer participating 
in the network. States must be in compliance with these provisions by 
the rating period for managed care contracts starting on or after July 
1, 2018, for all network providers. The 120 day timeframe is intended 
to encourage the state's expedient completion of the screening and 
enrollment process.
    Comment: A few commenters requested that CMS clarify in regulation 
that managed care plans would be insulated from any penalties if they 
detrimentally relied on the state's screening for a network provider 
that is later found to have been excluded or sanctioned.
    Response: We appreciate the commenters' concerns but the creations 
of a blanket protection for managed care plans that detrimentally 
relied on the state's screen of a network provider would be contrary to 
some of the prohibited affiliation requirements at Sec.  438.610 that 
do not premise liability on a ``knowing'' requirement. We refer 
commenters to the discussion of comments received on Sec.  438.610 
below.
    Comment: Several commenters were concerned about the potential 
application of the screening and enrollment provisions to providers of 
self-directed services under section 1915(k) of the Act and requested 
that such providers be exempt from these requirements.
    Response: We decline to adopt the commenters' recommendation. The 
requirements at 42 CFR part 455, subparts B and E are applicable to all 
provider types eligible to enroll as participating providers in the 
state's Medicaid program as it is integral to the integrity of the 
Medicaid program that all providers that order, refer or furnish 
services to Medicaid beneficiaries are appropriately screened and 
enrolled. For provider types that exist in both Medicare and Medicaid, 
states must use the same (or higher) level of screening assigned by 
Medicare. For Medicaid-only provider types such as those participating 
under a section 1915(k) waiver program, the state must assign the 
provider types to a risk level and conduct the level of screening 
associated with that risk level as described at Sec.  455.450.
    Comment: Some commenters requested that CMS permit an exemption 
from the screening and enrollment provisions for out-of-network 
providers under single case agreements or for providers rendering 
emergency services.
    Response: Out-of-network providers under single case agreements are 
not network providers and, therefore, are not subject to Sec.  
438.602(b). Emergency room physicians are only subject to Sec.  
438.602(b) to the extent that they meet the definition of a network 
provider in Sec.  438.2.
    Commenter: A few commenters requested clarification that a managed 
care plan could deny a provider participation in the network that 
passed the screening and enrollment requirements but failed the managed 
care plan's credentialing process. In addition, some commenters 
requested clarification that the managed care plan can terminate a 
provider agreement independent of the outcome of the state's screening 
and enrollment process.
    Response: This provision does not prevent the managed care plan 
from declining to enter into a network provider agreement with a 
provider that was otherwise screened and enrolled but did not meet the 
managed care plan's credentialing criteria. Similarly, this provision 
does not change the managed care plan's ability to terminate a provider 
agreement without cause.
    After consideration of public comments, we are finalizing Sec.  
438.602(b) as proposed and with a new paragraph (b)(2) to explain that 
managed care plans may execute network provider agreements pending the 
outcome of the screening process but upon notification from the state 
that a network provider cannot be enrolled, must terminate such 
agreement and notify affected enrollees.
    In paragraph (c), we proposed that the state must review the 
ownership and control disclosures submitted by the MCO, PIHP, PAHP, 
PCCM, or PCCM entity, and any subcontractors, in accordance with 42 CFR 
part 455, subpart B.
    We received the following comments in response to our proposal at 
Sec.  438.602(c).
    Comment: A few commenters requested that the state be permitted to 
delegate the requirements in Sec.  438.602(c), particularly for 
subcontractors. Many commenters suggested that it would be prudent and 
administratively efficient, for states to have a common entry point to 
streamline acceptance and review of the required information on 
disclosures. Another commenter asked that subcontractors not be 
included in Sec.  438.602(c) or, alternatively, be limited to 
subcontractors delegated for direct medical services or claims payment.
    Response: Section 438.602(c) governs the review of ownership and 
control disclosures required of managed care plans and subcontractors. 
We agree that a centralized portal would streamline the disclosure 
process and we encourage states to consider such approaches. 
Subcontractors, as they take on responsibility from the managed care 
plan, are appropriately subject to these requirements.

[[Page 27603]]

    After consideration of public comments, we are finalizing Sec.  
438.602(c) with a technical modification to refer to Sec.  438.608(c) 
rather than subpart B of part 455 of this chapter, as Sec.  438.608(c) 
incorporates the disclosure requirements in Sec.  455.104.
    In paragraph (d), we proposed that states must conduct federal 
database checks, consistent with the standards in Sec.  455.436, to 
confirm the identity of, and determine the exclusion and debarment 
status of, the MCO, PIHP, PAHP, PCCM, or PCCM entity, any 
subcontractor, any person with an ownership or control interest, or any 
agent or managing employee at the time of entering into the contract 
and no less frequently than monthly thereafter. If a state determines 
that a party subject to the federal database checks has been excluded 
from Medicaid participation, it must promptly notify the MCO, PIHP, 
PAHP, PCCM, or PCCM entity and take action consistent with Sec.  
438.610(c).
    We received the following comments in response to our proposal at 
Sec.  438.602(d).
    Comment: Several commenters requested that the rule be modified to 
allow use of the National Practitioner Data Bank (NPDB) to check for 
exclusion information. Other commenters recommended that the National 
Provider Identifier (NPI) should be a required element in the 
applicable federal databases.
    Response: Section 438.602(d) incorporates the federal databases 
that must be routinely checked consistent with Sec.  455.436. The NPDB 
is not among the specified databases, and checking the NPDB is not a 
substitute for checking the databases specified in Sec.  455.436. Use 
of the NPI in all applicable federal databases is outside the scope of 
this final rule. As indicated in the discussion above regarding Sec.  
438.602(b) and the required screening of network providers, states may 
require a third party, including managed care plans, to check the 
federal databases for network providers, to the extent managed care 
plans can access the required databases. In contrast, states may not 
permit managed care plans to conduct the database checks required 
pursuant to Sec.  438.602(d) for contracted managed care plans or their 
subcontractors. After consideration of public comments, we are 
finalizing Sec.  438.602(d) as proposed with a technical correction to 
add the National Plan and Provider Enumeration System (NPPES) in the 
list of databases in Sec.  455.436.
    In paragraph (e), we proposed that the state must periodically, but 
no less frequently than once every 3 years, conduct, or contract for 
the conduct of, an independent audit of the accuracy, truthfulness, and 
completeness of the encounter and financial data submitted by, or on 
behalf of, each MCO, PIHP, and PAHP.
    We received the following comments in response to our proposal at 
Sec.  438.602(e).
    Comment: One commenter requested that the audit of encounter data 
and financial reports occur annually rather than once every 3 years 
because of the importance of this information to the rate setting 
process. Another commenter requested that we expand the periodic audit 
requirement to other aspects of the managed care program in this part. 
Another commenter requested clarification that the EQR optional 
activity at Sec.  438.358(c)(1) could satisfy this requirement.
    Response: While we agree that encounter data and financial reports 
are integral to the rate setting process and are required sources of 
base data at Sec.  438.5(c), there are other requirements relating to 
the accuracy of encounter data (Sec.  438.242 and Sec.  438.818) and 
financial reports (Sec.  438.3(m)) that impose more frequent validation 
or audit requirements. The optional EQR activity at Sec.  438.358(c)(1) 
would satisfy the periodic audit requirement for encounter data but 
there is not a similar activity for the EQR to similarly audit 
financial reports. The evaluation of other elements of the managed care 
program are addressed elsewhere in this part and Sec.  438.602(e) is 
limited to the auditing requirements for program integrity related 
provisions and we decline to add additional program elements to this 
audit requirement.
    After consideration of public comments, we are finalizing Sec.  
438.602(e) as proposed.
    In paragraph (f), we proposed to incorporate the requirement for 
states to receive and investigate information from whistleblowers. We 
did not receive comments on Sec.  438.602(f) and will finalize as 
proposed.
    In paragraph (g), we proposed that each state must post on its Web 
site or otherwise make available, the MCO, PIHP, PAHP, or PCCM entity 
contract, the data submitted to the state under Sec.  438.604, and the 
results of any audits conducted under paragraph (e) of this section. We 
proposed to add PCCM entity contracts to this standard as we proposed 
in Sec.  438.3(r) that such contracts be submitted for our review and 
approval.
    We received the following comments in response to our proposal at 
Sec.  438.602(g).
    Comment: Many commenters supported the transparency requirements at 
Sec.  438.602(g) and recommended that states be required to put all the 
specified information on their Web sites. On the other hand, several 
commenters, while supporting overall efforts at transparency, stated 
that the list of information that would be on the Web site or made 
available upon request was overly burdensome and may cause concerns 
about the confidentiality of proprietary and enrollee information as 
well as general privacy concerns for the individuals that submit 
ownership and control disclosures. Commenters provided that the 
reporting requirements, as proposed, would not create meaningful 
transparency for the public as an insurmountable quantity of 
information keeps individuals from accessing the most pertinent and 
useful information.
    Response: We agree that the proposed rule was overly broad in the 
types of information that would need to be on the state's Web site or 
made available upon request. Accordingly, we are modifying Sec.  
438.602(g) to narrow the information that must be made publicly 
available on the state's Web site as follows: the MCO, PIHP, PAHP or 
PCCM entity contract; data required by Sec.  438.604(a)(5); the name 
and title of individuals included in Sec.  438.604(a)(6); and the 
results of any audits under paragraph (e). We will not finalize the 
requirement that certain other types of information must be available 
upon request as any such requests would be handled through the state's 
relevant sunshine or freedom of information laws. We also added ``as 
required in Sec.  438.10(c)(3)'' after ``Web site'' for clarity.
    After consideration of public comments, we are finalizing Sec.  
438.602(g) with modification of the types of information that must be 
provided on the state's Web site.
    In paragraph (h), we proposed that states have conflict of interest 
safeguards in place consistent with Sec.  438.58. We did not receive 
comments on Sec.  438.602(h) and are finalizing as proposed.
    In paragraph (i), we proposed that the state must ensure, 
consistent with section 1902(a)(80) of the Act, that the MCO, PIHP, 
PAHP, PCCM, or PCCM entity is not located outside of the United States 
and that no payments are made for services or items to any entity or 
financial institution outside of the U.S. We interpreted this payment 
prohibition to mean that no such payments made by an MCO, PIHP, or PAHP 
to an entity or financial institution located outside of the U.S.

[[Page 27604]]

are considered in the development of actuarially sound capitation 
rates.
    We received the following comments in response to our proposal at 
Sec.  438.602(i).
    Comment: One commenter requested confirmation as part of the final 
rule that the SMDL #10-026, issued in December 2010, remains in effect 
and that the guidance and final rule would permit managed care plans to 
undertake the same administrative tasks permitted by CMS. Another 
commenter requested clarification on the proposed requirement that no 
claims paid by a managed care plan to a subcontractor located outside 
the United States are to be considered in the development of 
actuarially sound capitation rates. For example, a managed care plan 
may subcontract with a vendor that employs an overseas company for IT 
or other operational services. The commenter stated that, in this case, 
the prohibition on services provided under the state plan should not 
apply to downstream contracts for administrative services. In addition, 
at least one state contract requires a managed care plan to cover 
emergency admissions in border countries. In this case, the managed 
care plan should not be penalized if coverage is required under the 
contract. Finally, managed care plans should be allowed to utilize out-
of-country services in some limited circumstances; for example, a U.S. 
licensed and credentialed physician who happens to be out of the 
country but is an employee of a U.S.-based telemedicine company.
    Response: The SMDL #10-026 that provided guidance on section 
1902(a)(80) of the Act remains in effect; the SMDL is available at 
http://www.medicaid.gov/Federal-Policy-Guidance/downloads/SMD10026.pdf. 
The intent of Sec.  438.602(i) was to extend that statutory limitation 
to medical assistance provided by contracted managed care plans. As was 
provided in the SMDL 10-026, the phrase ``items or services provided 
under the State plan or under a waiver'' refers to medical assistance 
for which the state claims federal funding under section 1902(a) of the 
Act. Tasks that support the administration of the Medicaid state plan 
that may require payments to financial institutions located outside of 
the U.S. are not prohibited under this statute. For example, payments 
for outsourcing information processing, call centers related to 
enrollment, or claims adjudication are not prohibited under this 
statute. The SMDL 10-026 clearly specifies that section 1902(a)(80) of 
the Act prohibits payments to telemedicine providers located outside of 
the U.S. Section 1902(a)(80) of the Act does not permit FFP for 
emergency services rendered outside of the U.S.
    After consideration of public comments, we are finalizing Sec.  
438.602(i) as proposed.
(3) Data, Information, and Documentation That Must be Submitted (Sec.  
438.604) and Source, Content, and Timing of Certification (Sec.  
438.606)
    We proposed to modify existing standards regarding submission and 
certification of data by managed care plans, PCCMs and PCCM entities to 
the state which currently exist in Sec. Sec.  438.604 and 438.606. We 
proposed to revise Sec.  438.604(a) and (b) to specify the data, 
information and documentation that must be submitted by each MCO, PIHP, 
PAHP, PCCM, or PCCM entity to the state, including encounter data and 
other data generated by the managed care plan for purposes of rate 
setting; data on which the state determined that the entity met the MLR 
standards; data to ensure solvency standards are met; data to ensure 
availability and accessibility of services; disclosure information as 
described at 42 CFR part 455, subpart B; the annual report on 
recoveries of overpayments as proposed in Sec.  438.608(d)(3); and any 
other data related to the performance of the entity's obligations as 
specified by the state or the Secretary.
    Comments received on proposed Sec.  438.604 were primarily related 
to the transparency requirements in Sec.  438.602(g). Those comments 
were addressed in response to comments on Sec.  438.602(g) above. 
Therefore, we are finalizing Sec.  438.604 as proposed.
    Section Sec.  438.606 stipulated that MCOs, PIHPs, PAHPs, PCCMs, 
and PCCM entities must certify the data, information and documentation 
specified in Sec.  438.604. We proposed to expand the certification 
requirement to documentation and information, as well as data and 
proposed to cross-reference the submission standards in Sec.  438.604 
to identify the scope of the certification requirement. In Sec.  
438.606(a), we proposed to eliminate the option for a MCO's, PIHP's, 
PAHP's, PCCM's, or PCCM entity's executive leadership to delegate the 
certification.
    We received the following comments in response to Sec.  438.606(a).
    Comment: Several commenters stated that not permitting 
certification by an individual with delegated authority from the CEO or 
CFO would be administratively burdensome, particularly for the 
certification of data, information, and documentation that is provided 
in the regular course of business.
    Response: Although we stated in the proposed rule that we believed 
that in these critical program areas, the CEO or CFO must be personally 
responsible for the accuracy, completeness, and truthfulness of the 
reported data, documentation or information, upon further 
consideration, we agree with commenters that the proposed requirement 
was overly restrictive and potentially disruptive to a managed care 
plan's daily operations. An individual that has the authority to sign 
on a CEO's or CFO's behalf, and who reports directly to those 
individuals, binds the CEO or CFO to the attestations made through the 
signature, which arrives at the desired result of the certification 
process.
    After consideration of public comments, we are modifying Sec.  
438.606(a) to permit an individual who reports directly to the managed 
care plan's CEO or CFO with delegated authority to sign for the CEO or 
CFO, so that the CEO or CFO remains ultimately responsible for the 
certification, to be the source of the certification required in this 
section. We are also modifying this paragraph with grammatical changes 
to insert semi-colons where appropriate.
    In Sec.  438.606(b), we proposed to include documentation or 
information after the existing reference to data for consistency with 
the addition of such terms in Sec.  438.604 and Sec.  438.606 and to 
specify that the certification attests that the MCO, PIHP, PAHP, PCCM, 
or PCCM entity has conducted a reasonably diligent review of the data, 
documentation, and information in Sec.  438.604(a) and (b), and that 
such data, documentation, and information is accurate, complete, and 
truthful. We proposed this modification to the certification to clarify 
that the attesting individual has an affirmative obligation to ensure 
that a reasonably diligent review has been conducted and that the 
information being certified is accurate, complete, and truthful. We 
requested comment on the proposed certification language.
    We received the following comments on Sec.  438.606(b).
    Comment: Several commenters requested clarification as to what the 
revised certification standard would require and stated that CMS has 
long recognized that the ``best information, knowledge, and belief'' as 
a reasonable and appropriate standard for certifications. A commenter 
noted that none of the certification requirements in the MA and Part D 
programs, including for reporting overpayments, specify that the 
certification is based on a ``reasonably diligent'' review, as

[[Page 27605]]

provided at Sec.  438.606(b). Commenters stated that adding this new 
standard for Medicaid data submissions would create an inappropriate 
degree of ambiguity for those certifying data to CMS and diverge from 
the standards in place for MA and Part D programs.
    Response: We agree with commenters that the existing certification 
language for data submissions under MA and Part D does not explicitly 
reference a ``reasonable diligence'' standard under the MA and Part D 
overpayment regulation at Sec.  422.326. To be consistent across 
programs, we will maintain the existing ``best information, knowledge, 
and belief'' language for certifications by managed care plans in Sec.  
438.606. However, we restate here our well-established expectation that 
any certifications by a managed care plan cannot be based on a blind or 
careless acceptance of information, including data critical to payment 
determinations, but must be informed. For indications of our historical 
views on the matter, we urge the commenters to look at our comments 
regarding the certifications in 2001 to the part 438 rule (66 FR 6228, 
6357 (Jan. 19, 2001)) and in 2000 to the similar rule for Medicare Part 
C (65 FR 40170, 40268 (June 29, 2000)). We note that the emphasis on 
program and payment integrity throughout part 438 aligns with our 
expectations for certifications to be based on a reasonably diligent 
review of the accuracy, completeness, and truthfulness of the data, 
documentation, and information. As one example, under Sec.  438.608(a), 
we require states, through their contracts with each MCO, PIHP, or 
PAHP, to ensure the managed care plans and their subcontractors 
maintain a compliance program that has procedures for routine 
monitoring and auditing of compliance risks and requires the entities 
to have arrangements or procedures for prompt reporting of all 
overpayments identified or recovered.
    After consideration of public comments, we are finalizing Sec.  
438.606(b) to include the best information, knowledge, and belief 
language for certifications by managed care plans.
    In paragraph (c), we proposed to maintain the existing standard 
that the certification is provided concurrently with the submission of 
the data, documentation or information specified in Sec.  438.604. We 
did not receive comments on Sec.  438.606(c) and are finalizing as 
proposed.
(4) Program Integrity Requirements Under the Contract (Sec.  438.608)
    Current Sec.  438.608 specifies the elements that must be included 
in a MCO's and PIHP's program integrity/compliance program and 
administrative procedures to detect and prevent fraud, waste and abuse. 
We proposed to expand those standards to PAHPs and subcontractors to 
the extent that the subcontractor is delegated responsibility by the 
MCO, PIHP, or PAHP for coverage of services and payment of claims under 
the contract between the state and the MCO, PIHP, or PAHP.
    We received the following general comments on Sec.  438.608(a).
    Comment: A commenter recommended removing the language requiring 
subcontractors of MCOs, PIHPs, and PAHPs to be subject to provisions of 
Sec.  438.608 and instead require MCOs, PIHPs, and PAHPs to maintain 
effective and reasonable oversight of subcontractors.
    Response: We disagree. It is imperative that subcontractors that 
take on responsibilities of the MCO, PIHP, and PAHP under the contract 
and have the same program integrity structure as the MCOs, PIHP, or 
PAHP. At Sec.  438.230(b)(1), the final rule requires MCOs, PIHPs, and 
PAHPs to oversee the activity of subcontractors and specifies that the 
MCO, PIHP, and PAHP retains ultimate responsibility for the obligations 
under the contract. This regulatory structure is important to the 
integrity of the Medicaid program, especially in states that rely on 
heavily sub-delegated arrangements.
    Comment: One commenter provided that the state should be required 
to issue guidance related to all program integrity activities 
undertaken by managed care plans, the managed care plans should be 
required to demonstrate validity and accuracy of any planned program 
integrity project based on sampling or data mining before it is 
implemented, and the state should coordinate program integrity 
activities by the managed care plans on issues likely to be in common.
    Response: We appreciate the commenter's recommendations but decline 
to require such activities in the regulation. Section 438.66 includes 
program integrity as an area for ongoing monitoring by the state and 
the ability of the managed care plan to comply with the program 
integrity requirements is a required element of the readiness review.
    Comment: Some commenters requested that CMS engage a stakeholder 
workgroup before expanding program integrity requirements.
    Response: The requirements in subpart H in this final rule were 
informed by the public comments received and we will finalize these 
provisions, with some modifications, as described herein. We will not 
create a stakeholder workgroup before finalizing these provisions.
    Comment: A commenter asked how these rules would impact those 
provider organizations that are looking to become stand-alone, risk-
bearing managed care plans or are adopting different partnership models 
with managed care plans.
    Response: If the provider organization or collaborative model would 
meet the definition of an MCO, PIHP, or PAHP, the requirements of this 
part would apply.
    We proposed the following changes to Sec.  438.608:
     Establishment of written policies, procedures, and 
standards of conduct that articulate the organization's commitment to 
comply with all applicable requirements and standards under the 
contract, and all applicable Federal and state requirements (proposed 
to redesignate Sec.  438.608(b)(1) as Sec.  438.608(a)(1)(i)). We did 
not receive comments on Sec.  438.608(a)(1)(i) and will finalize the 
provision as proposed.
     Direct reporting by the Compliance Officer to both the CEO 
and board of directors of the MCO, PIHP, or PAHP, which is consistent 
with MA requirements at Sec.  422.503(b)(4)(vi)(B)(2); the designation 
of compliance officer that is accountable to senior management is at 
current Sec.  438.608(b)(2) (proposed Sec.  438.608(a)(1)(ii)). We 
received the following comments on proposed Sec.  438.608(a)(1)(ii).
    Comment: A few commenters were supportive of the proposed change to 
align with the MA standard for Compliance Officers, while a few others 
through that the requirements were too prescriptive. A commenter 
recommended that a Compliance Officer should be able to report to 
another executive level position for supervisory purposes as long as 
the job description clearly provides for direct reporting in terms of 
compliance activities to the CEO and board of directors on a regular 
basis.
    Response: We appreciate the supportive comments and agree that it 
is appropriate to align with MA. The commenters' recommendation that 
the Compliance Officer be able to report to another executive level 
position for supervisory purposes as described the summary of comments 
is permissible under this provision.

[[Page 27606]]

    After consideration of public comments, we are finalizing Sec.  
438.608(a)(1)(ii) as proposed.
     Establishment of a Regulatory Compliance Committee on the 
Board of Directors and at the senior management level charged with 
oversight of the compliance program for consistency with MA 
requirements at Sec.  422.502(b)(4)(vi)(B). We received the following 
comments on proposed Sec.  438.608(a)(1)(iii).
    Comment: A commenter requested clarification that the managed care 
plan has the authority to determine the composition of the Regulatory 
Compliance Committee; for example, the number of board meetings, 
frequency of meetings, etc.
    Response: The federal standard permits the managed care plans such 
discretion. States may add additional requirements through the 
contract.
    After consideration of public comments, we are finalizing Sec.  
438.608(a)(1)(iii) as proposed.
     Establishment of a system for training and education for 
the Compliance Officer, the organization's senior management, and the 
organization's employees for the federal and state standards and 
requirements under the contract for consistency with MA organization 
requirements at Sec.  422.503(b)(4)(vi)(C). We did not receive comments 
on proposed Sec.  438.608(a)(1)(iv) and are finalizing as proposed.
     Establishment of a system for effective communication 
between the compliance officer and the organization's employees 
(proposed to redesignate Sec.  438.608(a)(4) as Sec.  
438.608(a)(1)(v)). We did not receive comments on Sec.  
438.608(a)(1)(v) and are finalizing as proposed.
     Enforcement of standards through well-publicized 
disciplinary guidelines (proposed to redesignate Sec.  438.608(b)(5) as 
Sec.  438.608(a)(1)(vi)). We did not receive comments on Sec.  
438.608(a)(1)(vi) and are finalizing as proposed.
     Establishment and implementation of procedures and a 
system with dedicated staff for routine internal monitoring and 
auditing of compliance risks, prompt response to compliance issues as 
they are raised, investigation of potential compliance problems as 
identified in the course of self-evaluation and audits, correction of 
such problems promptly and thoroughly (or coordination of suspected 
criminal acts with law enforcement agencies) to reduce the potential 
for recurrence, and ongoing compliance with the requirements under the 
contract; the provision for internal monitoring and auditing and prompt 
response to detected offenses is at current Sec.  438.608(b)(6) and (7) 
(proposed Sec.  438.608(a)(1)(vii)).
    We received the comments on Sec.  438.608(a)(1)(vii):
    Comment: A few commenters requested clarification as to the measure 
of ``prompt'' as related to responding to compliance issues.
    Response: We decline to set forth a specific definition for 
``prompt'' in the regulation and note that the use of ``prompt'' was in 
Sec.  438.608(b)(7) in the 2002 final rule--pertaining to the response 
of the managed care plan to detected offenses and for the development 
of corrective action initiatives--and that section informed the 
development of Sec.  438.608(a)(1)(vii). We defer to states to set 
forth specific parameters for a measure of ``promptness'' in the 
managed care contracts. This response applies to comments similarly 
requesting clarification on the use of ``prompt'' elsewhere in this 
subpart.
    Comment: A few commenters requested clarification of ``dedicated 
staff'' in this paragraph.
    Response: The term ``dedicated staff'' means that the job 
description includes the activities in Sec.  438.608.
    After consideration of public comments, we are finalizing Sec.  
438.608(a)(1)(vii) as proposed.
     Mandatory reporting to the state or law enforcement of 
improper payments identified or recovered, specifying the improper 
payments due to potential fraud. We received the following comments on 
proposed Sec.  438.608(a)(2).
    Comment: One commenter requested that CMS give states the explicit 
authority to articulate additional expectations for defining and 
reporting on fraud and improper payments. State should be permitted, 
but not required, to define improper payments in the context of state 
program integrity efforts. Another commenter suggested that states 
should be able to specify additional staffing requirements for the 
managed care plan.
    Response: As stated in response to comments for other provisions in 
this final rule, states have the flexibility to establish standards 
that are more restrictive than the requirements of this part through 
the contract.
    Comment: Many commenters requested clarification on the definition 
of ``potential fraud'' used in this provision and others in this 
subpart. Another commenter suggested that the reporting requirement 
only apply to ``actual fraud.''
    Response: Fraud is defined in Sec.  455.2 and for purposes of 
identifying improper payments identified or recovered relating to 
``potential fraud'' in this section, that is conduct that the managed 
care plan believes to be fraud as defined in Sec.  455.2. We note that 
a managed care plans cannot, themselves, determine whether something 
meets the legal definition of fraud. That determination must be made by 
law enforcement and the courts. Thus, we disagree that the reporting 
requirement should be limited to actual fraud.
    For clarity in this part, we will add a definition for ``fraud'' in 
Sec.  438.2 that incorporates the definition found in Sec.  455.2.
    Upon review of this provision, as proposed, we identified two areas 
within the provision that require modification to clarify the 
regulatory standard. First, the use of the term ``improper payments'' 
in the proposed provision could have been interpreted to incorporate 
Payment Error Rate Measurement (PERM) requirements, and that was not 
our intention. Our intention for Sec.  438.608(a)(2) is that managed 
care plans promptly report overpayments to the state that are 
identified or recovered and, in that reporting, to specify the 
overpayments due to potential fraud. Second, overpayments must be 
reported to the state and it is not necessary that the managed care 
plan instead, or in addition to, report this information to law 
enforcement as proposed. Note that Sec.  438.608(a)(7) separately 
requires managed care plans to refer any potential fraud, waste, or 
abuse to the state Medicaid program integrity unit or any potential 
fraud directly to the state MFCU.
    After consideration of public comments, we are finalizing Sec.  
438.608(a)(2) with the following modifications: (1) Replacing 
``improper payments'' with ``overpayments''; and (2) deletion of law 
enforcement. In addition, to clarify the definition of ``fraud'' 
applicable in this paragraph and elsewhere in this part, we will 
finalize the rule with a cross-reference in Sec.  438.2 to the 
definition of ``fraud'' in Sec.  455.2.
     Mandatory reporting to the state of information received 
by managed care plans about changes in an enrollee's circumstances that 
may affect the enrollee's eligibility. We received the following 
comments on proposed Sec.  438.608(a)(3).
    Comment: Several commenters objected to Sec.  438.608(a)(3)(i) and 
(a)(3)(ii) because reporting on each piece of returned mail would be 
administratively burdensome and costly, and returned mail does not 
necessarily mean that the enrollee is no longer eligible for Medicaid. 
In addition,

[[Page 27607]]

the managed care plan would not likely be aware of changes in an 
enrollee's income. Another commenter suggested that the provision was 
of little value because the state's MMIS is the ultimate system of 
record.
    Response: We agree with the commenters that the value of reporting 
returned mail is outweighed by the administrative burden and that 
managed care plans would have little to no expectation of receiving 
information on the enrollee's income that could be of value to the 
state, and thus, returned mail would not be sufficient to trigger the 
reporting requirements under Sec.  438.608(a)(3)(i) or (ii). We believe 
that the managed care plans have more direct communication with 
enrollees than the state and can serve as valuable sources of 
information relevant to the enrollee's eligibility for Medicaid.
    After consideration of public comments, we are finalizing Sec.  
438.608(a)(3) so that managed care plans would notify the state of 
changes in the enrollee's residence and death.
     Mandatory reporting to the state of information received 
by the managed care plan about changes in a provider's circumstances 
that may affect the provider's participation in the managed care 
program. Such changes in circumstances would include the termination of 
the network agreement with the managed care plan.
    We received the following comment on proposed Sec.  438.608(a)(4).
    Comment: One commenter suggested that changes in provider 
eligibility reported to the state should mirror the existing Medicare 
requirement for provider reporting to the Medicare Administrative 
Contractors (MAC).
    Response: Provider reporting to the MACs applies to providers that 
participate in Medicare Parts A and B. The intention of Sec.  
438.608(a)(4) is for managed care plans to alert the state of changes 
in a network provider's circumstances that may impact the network 
provider's participation in the state's Medicaid managed care program. 
States may incorporate additional reporting requirements for network 
providers through the managed care contracts.
    After consideration of public comments, we are finalizing Sec.  
438.608(a)(4) as proposed.
     Verification by sampling or other methods, whether 
services that were represented to have been delivered by network 
providers were actually received. We received the following comments on 
proposed Sec.  438.608(a)(5).
    Comment: Some commenters requested that CMS or the states provide 
clear and consistent guidance to managed care plans on the methods they 
can use to verify the delivery of services by network providers. 
Another commenter was opposed to any requirement for the use of 
Explanation of Benefits (EOBs) as a means to detect fraud and abuse 
given the extremely limited return; however, if verification is 
required, sampling that is limited in scope and easy to administer 
would be supported.
    Response: We prefer to leave to state discretion the sampling 
method or other methods used to verify that services represented to 
have been delivered to enrollees were actually provided to the managed 
care contract.
    After consideration of public comments, we are finalizing Sec.  
438.608(a)(5) as proposed.
     Establishment of written policies related to the Federal 
False Claims Act, including information about rights of employees to be 
protected as whistleblowers at proposed Sec.  438.608(a)(6). We did not 
receive comments on Sec.  438.608(a)(6) and will finalize with a minor 
grammatical change so that this provision reads correctly from the 
introductory language in paragraph (a).
     Mandatory referral of any potential fraud, waste, or abuse 
that the MCO, PIHP, or PAHP identifies to the State Medicaid program 
integrity unit or any potential fraud directly to the State Medicaid 
Fraud Control Unit (proposed Sec.  438.608(a)(7)). We explained that 
states that have a MFCU may choose, as part of their contracts with 
MCOs, PIHPs, or PAHPs, to stipulate that suspected provider fraud be 
referred only to the MFCU, to both the MFCU and to the Medicaid program 
integrity unit, or only to the Medicaid program integrity unit. For 
those matters referred to the Medicaid program integrity unit, 42 CFR 
part 455 provides that the unit must conduct a preliminary 
investigation and cooperate with the MFCU in determining whether there 
is a credible allegation of fraud. For those MCOs, PIHPs, and PAHPs 
with their own Special Investigation Unit (SIU) to investigate 
suspected provider fraud, the program integrity unit should assess the 
adequacy of the preliminary investigation conducted by those units and 
seek to avoid the duplication and delay of their own preliminary 
investigation.
    We received the following comments on Sec.  438.608(a)(7).
    Comment: A few commenters suggested that managed care plans should 
be required to refer fraud, waste and abuse to the Medicaid program 
integrity unit and states should have the option to also require 
simultaneous reporting to the state's MFCU. Another commenter wanted 
CMS to require managed care plans to coordinate with the MFCU.
    Response: Section 438.608(a)(7) requires managed care plans to 
refer any potential fraud, waste, or abuse to the state Medicaid 
program integrity unit or any potential fraud directly to the state 
MFCU. Section 455.21 specifies the level of cooperation between the 
state and the MFCU and does not require managed care plans to 
coordinate directly with the MFCUs. The contract would specify if the 
state wanted the managed care plan to refer potential fraud to the 
MFCU.
    Comment: A few commenters requested clarification on the meaning of 
``abuse'' in this paragraph.
    Response: The definition of ``abuse'' in Sec.  455.2 applies here 
and to any use of the term within this part. To clarify the meaning of 
``abuse'' in this paragraph and elsewhere in this part, we will 
finalize the rule with a cross-reference in Sec.  438.2 to the 
definition of ``abuse'' in Sec.  455.2.
    After consideration of public comments, we are finalizing Sec.  
438.608(a)(7) as proposed.
     Provision for the MCO's, PIHP's, or PAHP's suspension of 
payments to a network provider for which the state determines there is 
a credible allegation of fraud in accordance with Sec.  455.23 
(proposed Sec.  438.608(a)(8)). Under Sec.  455.23, which implements 
section 1903(i)(2)(C) of the Act, the state must suspend payments to an 
individual or entity against which there is a pending investigation or 
a credible allegation of fraud against the individual or entity, unless 
the state determines that there is good cause not to suspend such 
payments. Under our authority in sections 1903(i)(2)(C) and 1902(a)(4) 
of the Act, we proposed to require that the state make provision for 
the MCO, PIHP, or PAHP to suspend payment to a network provider when 
the state determines there is a credible allegation of fraud against 
that network provider, unless the state determines there is good cause 
for not suspending such payments pending the investigation. Under this 
provision, the responsibility of MCOs, PIHPs, and PAHPs is limited to 
promptly suspending payments at the direction of the state until 
notified by the state that the investigation has concluded.
    We received the following comments on proposed Sec.  438.608(a)(8).
    Comment: Several commenters requested clarification as to what 
would constitute a credible allegation of fraud. Other commenters 
provided that states must ensure that managed care plans are

[[Page 27608]]

notified of credible allegations of fraud and the need to suspend 
payment in a timely manner. Another commenter requested that states be 
required to notify the managed care plan in writing. A commenter 
suggested that CMS address the impact of suspension of payments to a 
provider on access to care.
    Response: ``Credible allegation of fraud'' is defined at Sec.  
455.2 for purposes of the payment suspension requirement. Section 
455.23 specifies written notification requirements and timeframes for 
such notification applicable to the state when notifying FFS providers 
of a payment suspension. These same requirements are applicable for 
purposes of notifying the managed care plans that payments to a network 
provider should be suspended under Sec.  438.608(a)(8). For additional 
information on Sec.  455.23, consult the CPI-CMCS Informational 
Bulletin CPI-B 11-4, available at https://downloads.cms.gov/cmsgov/archived-downloads/CMCSBulletins/downloads/payment-suspensions-info-bulletin-3-25-2011.pdf. We acknowledge that suspension of payments may, 
in some instances, impact access to care, but note that, in certain 
circumstances, Sec.  455.23(e) permits the state to determine that good 
cause exists not to suspend payments despite a credible allegation of 
fraud. Section 455.23(e)(4) expressly permits such a determination 
where beneficiary access to covered items or services would be 
jeopardized.
    After consideration of public comments, we are finalizing Sec.  
438.608(a)(8) as proposed.
    Section 438.608(b) incorporated the provider screening and 
enrollment standards in Sec.  438.602(b). Comments on this proposal 
were addressed in response to comments on Sec.  438.602(b). We are 
finalizing Sec.  438.608(b) as proposed.
    In paragraph (c) of Sec.  438.608, we proposed additional 
expectations for performance by managed care plans that the state must 
include in their contracts, including:
     Requiring MCOs, PIHPs, and PAHPs to disclose in writing 
any prohibited affiliation outlined in Sec.  438.610 (proposed 
paragraph (c)(1));
     Requiring written disclosures of information on control 
and ownership under Sec.  455.104 (proposed paragraph (c)(2)); and
     Requiring MCOs, PIHPs, and PAHPs to report to the state 
within 60 calendar days of when they identify receipt of payments in 
excess of the capitation rate or other payments established in the 
contract (proposed paragraph (c)(3)).
    We requested comment on whether we should establish timeframes for 
the written disclosures on control and ownership at proposed paragraph 
(c)(2).
    We did not receive comments on Sec.  438.608(c)(1) or (c)(2) and 
will finalize those provisions as proposed.
    We received the following comments on proposed Sec.  438.608(c)(3).
    Comment: A commenter requested clarification that proposed 
paragraph (c)(3) that would require managed care plans to report to the 
state within 60 calendar days of when they identify receipt of payments 
in excess of the capitation rate or other payments established in the 
contract would not satisfy the managed care plans' obligations under 
section 1128J(d) of the Act:
    Response: The reporting obligation in this paragraph pertains to 
one type of overpayment--capitation payments or other payments (such as 
a kick payment or similar arrangement) that are due to calculation 
errors in excess of the amounts specified in the managed care 
contract--under section 1128J(d) of the Act.
    Comment: Some commenters requested that CMS align with the MA 
approach for reporting of overpayments where a specific timeframe is 
not specified. A commenter stated that 60 days seemed too short 
considering the nature of payments. Another commenter stated that it 
needed to be clear that a determination that an overpayment exists 
before the obligation to report and refund is triggered in paragraph 
(c)(3).
    Response: As discussed in response to the previous comment, the 
payments at issue in paragraph (c)(3) are a subset of the overpayments 
defined under section 1128J(d) of the Act. The overpayments at issue in 
this rule include those that occur when the managed care plan 
identified capitation payments or other payments in excess of the 
amounts specified in its contract with the state, (for example, when 
the state incorrectly calculates the capitation payments or other 
payments due to a managed care plan). We do not consider any comments 
received on the 60 day timeframe as responsive to the extent they were 
based on an assumption that the payments at issue in this section were 
overpayments made to providers.
    After consideration of comments received, we are finalizing Sec.  
438.608(c)(3) as proposed.
    In Sec.  438.608(d)(1), we proposed that MCO, PIHP, and PAHP 
contracts specify that recoveries of overpayments made by the MCO, 
PIHP, or PAHP to providers that were excluded from Medicaid 
participation or that were due to fraud, waste or abuse were to be 
retained by the MCO, PIHP, or PAHP. We explained that because these 
overpayments represent state and federal Medicaid funds that were paid 
to the excluded or fraudulent providers by the MCO, PIHP, or PAHP, 
states are then expected to take such recoveries into account in the 
development of future actuarially sound capitation rates as proposed in 
Sec.  438.608(d)(4). The proposal in Sec.  438.608(d)(1) would not 
prohibit the federal government or states from retaining the 
appropriate share of recoveries of overpayments due to their own audits 
and investigation. We solicited comment on this proposal to allow MCOs, 
PIHPs, and PAHPs to retain overpayment recoveries of payments made to 
providers that were excluded from Medicaid participation or that were 
due to fraud, waste or abuse that were made by the managed care plan, 
while also allowing the federal government and states retain 
overpayment recoveries they make. We also requested comment on 
alternative approaches to determining when a recovery may be retained 
by an MCO, PIHP, or PAHP. Specifically, whether we should instead 
impose a timeframe between 6 months to 1 year for which the MCO, PIHP, 
or PAHP may act to initiate the recovery process and retain such 
recovered overpayments. We further proposed that, consistent with that 
contractual language, the state collect reports from each MCO, PIHP, or 
PAHP about recoveries of overpayments in proposed Sec.  438.608(d)(3).
    To aid in the creation and submission of such reports in proposed 
paragraph (d)(3), in paragraph (d)(2) we proposed a standard that the 
MCO, PIHP, or PAHP must have a mechanism in place for providers to 
report the receipt of overpayments and to return such overpayments to 
the MCO, PIHP, or PAHP within 60 calendar days after the overpayment 
was identified. For clarity, in proposed (d)(5) we define the term 
``overpayment.''
    We received the following comments in response to our proposal to 
add Sec.  438.608(d).
    Comment: Some commenters were supportive of the proposal at Sec.  
438.608(d)(1) that managed care plans would be able to retain 
recoveries of overpayments that the plans identified while others 
expressed opposition to such a requirement. Some suggested that states 
should retain complete flexibility to devise ways to incentivize 
managed care plans to identify such overpayments that would differ from 
the proposed rule.
    Some commenters recommended that the window for the managed care 
plan to identify, recover, and retain such

[[Page 27609]]

overpayments be limited to 6 months or one year from the point of 
identification by the managed care plan or from the initiation of the 
recovery. Another commenter suggested that no timeframe be imposed 
since the process to initiate, investigate and recover overpayments can 
be time-consuming and the managed care plan must honor a provider's due 
process and appeal rights.
    Some commenters recommended that overpayments made to excluded 
providers, as proposed at Sec.  438.608(d)(1)(i), should not be 
permitted to be retained as the managed care plan never should have 
made a payment to an excluded provider. A few commenters wanted it to 
be clarified that all overpayments identified by the MFCU or under a 
False Claims Act case should be fully retained by the state.
    Response: We believe that the ability of managed care plans to 
retain overpayments that they identified and recovered is a reasonable 
mechanism to incentivize managed care plans to oversee the billing 
practices of network providers. The goal of the proposal was to 
incentivize managed care plans to undertake monitoring on a proactive 
basis to determine if fraud, waste or abuse exists within the provider 
network. Based on this goal, states should consider ways to properly 
incent proactive identification and recovery of overpayments by the 
contracted managed care plans. For example, timeframes for the managed 
care plan to retain recoveries should not be open ended, as such an 
approach may not properly incentivize managed care plans to take swift 
action when such overpayments are identified.
    However, in light of comments received on this proposal and after 
further consideration, it is clear that a number of states have long-
standing procedures in place for the treatment of overpayments 
recovered by managed care plans that differ from the approach in the 
proposed rule. It also became clear to us that implementing this 
provision as proposed may result in ambiguity as to when an overpayment 
was identified for purposes of entitlement to the recovery. Therefore, 
we will not finalize Sec.  438.608(d) as proposed and instead finalize 
a requirement that permits states flexibility to set forth an approach 
to overpayment recoveries in the managed care plan contracts. As 
provided in a new paragraph Sec.  438.608(d)(1)(i), the state will need 
to address in its contracts the retention policies for the treatment of 
recoveries of all overpayments from the MCO, PIHP, or PAHP, and in 
particular, the policy for recoveries of overpayments due to fraud, 
waste, or abuse. A new paragraph (d)(1)(ii) provides that the contract 
must specify the process, timeframes, and documentation required of the 
managed care plans for reporting the recovery of all overpayments. 
Finally, a new paragraph (d)(1)(iii) requires that the contract specify 
the process, timeframes, and documentation required for the payment of 
recoveries of overpayments to the state if the managed care plan is not 
permitted to retain some or all of the recoveries. We believe that this 
revised approach respects current approaches that are working well 
within a Medicaid managed care program, but it also requires states to 
have policies in place for the treatment of managed care plan 
recoveries of overpayments.
    States must ensure that contract provisions implementing Sec.  
438.608(d)(1) are consistent with other requirements under federal law 
and this part. For example, Sec.  438.608(d)(2) requires network 
providers to return overpayments to MCOs, PIHPs, and PAHPs within 60 
days once the overpayment is identified. We may provide additional 
guidance regarding Sec.  438.608(d)(1) to ensure that states 
incorporate appropriate requirements into their overpayment retention 
contract provisions. Although states have the flexibility to implement 
overpayment retention contract provisions, the policies in the contract 
would not prohibit the federal government from retaining the 
appropriate share of recoveries of overpayments due to their own audits 
and investigations.
    After consideration of public comments, we are finalizing Sec.  
438.608(d)(1) to require states to have policies in place for the 
treatment of overpayment recoveries and to specify that policies 
implemented pursuant to this provision do not apply to the retention of 
recoveries made under the False Claims Act or through other 
investigations.
    Comment: A few commenters stated that the 60 day timeframe in Sec.  
438.608(d)(2) for network providers to return an overpayment to the 
managed care plan was unrealistic and potentially burdensome on small 
providers.
    Response: Section 438.608(d)(2) incorporates the statutory 
timeframe for the return of overpayments under section 1128J(d) of the 
Act.
    Comment: A commenter recommended that CMS implement the same look-
back period of 5 years that the agency already has in place with the 
Zone Program Integrity Contractors (ZPICs) for the Medicare program.
    Response: The link the commenter makes between this provision and 
the work of ZPICs is not clear; therefore, we consider this comment to 
be beyond the scope of this rule.
    After consideration of public comments, we are finalizing Sec.  
438.608(d)(2) as proposed. We did not receive comments on paragraph 
(d)(3) and will finalize as proposed. We did not receive comments on 
paragraph (d)(4) but, for consistency with the final provisions in 
Sec.  438.608(d)(1), we will finalize this paragraph as proposed and 
with an additional requirement that the information and documentation 
collected pursuant to paragraph (d)(1) must be used by the state for 
purposes of setting actuarially sound capitation rates.
    We received the following comment on proposed Sec.  438.608(d)(5).
    Comment: A commenter stated that the definition of an overpayment 
in Sec.  438.608(d)(5) was confusing and should be clarified or 
deleted.
    Response: The definition of an ``overpayment'' in Sec.  438.608(d) 
is modeled after the statutory language in section 1128J(d) of the Act 
and for consistency with the provision at Sec.  438.608(c)(3), we will 
finalize the definition of overpayments to include any payments to a 
managed care plan by a state to which the managed care plan was not 
entitled under the Act.
    After consideration of public comments, we will finalize the 
definition of an ``overpayment,'' as proposed and with a modification 
to reflect a state's payments to managed care plans to which the plans 
are not entitled, in the general definition section at Sec.  438.2, 
rather than in Sec.  438.608(d), as the term appears in multiple 
sections of this part.
(5) Prohibited Affiliations (Sec.  438.610)
    We proposed to revise the title of Sec.  438.610 from ``Prohibited 
affiliations with individuals debarred by federal agencies'' to 
``Prohibited affiliations.'' This proposed change was in recognition of 
the addition of individuals or entities excluded from Medicaid 
participation under section 1128 of the Act. In paragraph (a), which 
provided the general standards under this section, we added PCCM and 
PCCM entities through our authority for the proper and efficient 
administration of the state plan in section 1902(a)(4) of the Act.
    In paragraphs (a)(1) and (a)(2) that specify the types of knowing 
relationships in section 1932(d)(1)(C) of the Act, we proposed to 
clarify that these relationships may be with individuals or entities 
that meet those

[[Page 27610]]

criteria. The existing language referred only to individuals and the 
proposed edits were consistent with the definition of ``persons'' in 
the Federal Acquisition Regulation and the Nonprocurement Common Rule. 
In addition, we proposed to add paragraph (b) to include individuals or 
entities excluded from Medicaid participation under section 1128 or 
1128A of the Act in the list of prohibited relationships by the MCO, 
PIHP, PAHP, PCCM, or PCCM entity, as specified in section 1902(p)(2) of 
the Act. We noted that, in the case of excluded individuals and 
entities, the prohibition applies whether or not the relationship is 
known to the MCO, PIHP, PAHP, PCCM, or PCCM entity.
    We proposed to redesignate paragraph (b) that specified the 
relationships that are prohibited as paragraph (c) to accommodate the 
proposed inclusion of individuals or entities excluded from 
participation under section 1128 of the Act. In addition, we proposed 
to add subcontractors of the MCO, PIHP, PAHP, PCCM, or PCCM entity as 
described in Sec.  438.230 to the types of prohibited relationships in 
paragraph (c)(3). In paragraph (c)(4), we proposed to add network 
providers to clarify that they fall under the employment or other 
consulting arrangement for items and services under the contract 
between the state and the managed care plan.
    Due to the proposed restructuring of paragraphs within this 
section, we redesignated paragraph (c) as paragraph (d) without change, 
with the exception of the following modifications. In paragraph (d)(3), 
we proposed to clarify that the reasons for continuation of a managed 
care plan's agreement with a prohibited individual or entity must be 
compelling despite the prohibited affiliation. In addition, we proposed 
a new paragraph (d)(4) to clarify that this section does not limit or 
affect any remedies available to the federal government under sections 
1128, 1128A or 1128B of the Act. Finally, we proposed to redesignate 
paragraph (d) as paragraph (e) without change.
    We received the following comments in response to our proposal to 
revise Sec.  438.610.
    Comment: A few commenters stated that managed care plans, PCCMs, 
and PCCM entities should only be responsible for prohibited 
affiliations that they know about. Another writer commented that 
managed care plans, PCCMs, and PCCM entities should be responsible for 
all affiliations whether known or not, because otherwise it would be 
unclear who was responsible for reimbursing payment.
    Response: As described in the proposed rule at 80 FR 31131, Sec.  
438.610 addresses two different statutory requirements. Paragraphs 
(a)(1) and (a)(2) address section 1932(d)(1)(A) of the Act and that 
statutory provision includes a knowledge requirement. Paragraph (b) 
incorporates section 1902(p)(2) of the Act and that statutory provision 
does not have a knowledge requirement. Therefore, we do not have the 
ability to modify those requirements through regulation.
    Comment: A commenter asked whether the state had to report to the 
Secretary if a prohibited provider affiliation became known after the 
provider had already been enrolled.
    Response: Yes, the state reporting requirement is not limited to 
pre-enrollment knowledge of prohibited provider affiliations.
    Comment: A commenter stated that CMS should clarify that any 
consequences noted in this section would apply in addition to 
consequences for failure to comply with a condition of payment.
    Response: As proposed, Sec.  438.610(d)(4) stated that nothing in 
this section must be construed to limit or otherwise effect any 
remedies available to the U.S. under sections 1128, 1128A, or 1128B of 
the Act, and thus makes it clear that this section does not supersede 
other remedies for inappropriate payment to prohibited affiliates.
    After consideration of the public comments, we are finalizing Sec.  
438.610 as proposed.
d. Sanctions (Sec. Sec.  438.700, 438.702, 438.704, 438.706, 438.708, 
438.722, and 438.730)
    Throughout subpart I pertaining to sanctions, we proposed to extend 
standards applicable to PCCMs to PCCM entities, as we proposed to 
recognize PCCM entities as a type of PCCM as defined in section 
1905(t)(2) of the Act and referenced in section 1932(a)(1)(B)(ii) of 
the Act. The discussion of the proposed recognition and application of 
standards in this part to PCCM entities is described in section 
I.B.6.e. of this final rule. Therefore, we proposed to add PCCM 
entities to Sec.  438.700(a), (c), and (d)(2); Sec.  438.704(a); Sec.  
438.708; and Sec.  438.722.
    In Sec.  438.700(a), we proposed to clarify that the intermediate 
sanctions specified in Sec.  438.702 ``may'' be used by the state, 
rather than providing that these ``must'' be the sanctions that the 
state establishes. The current regulation could be interpreted to mean 
that the specific intermediate sanctions enumerated must be used by the 
state, even though section 1932(e)(1) of the Act only stipulates that 
intermediate sanctions be in place for the specified violations, and 
that such intermediate sanctions may include those specified in section 
1932(e)(2) of the Act and set forth in Sec.  438.702. The standard in 
section 1932(e)(1) of the Act that is a condition for having or 
renewing a MCO contract is only that there be intermediate sanctions in 
place.
    In Sec.  438.700(c), we proposed to delete PIHPs and PAHPs from the 
state's determination that unapproved or misleading marketing materials 
have been distributed as provided for in the last sentence of section 
1932(e)(1) of the Act. In the 2002 final rule, we included PIHPs and 
PAHPs in the regulation text implementing this sentence but have 
determined that the statutory provision, by its terms, only applies to 
a ``managed care entity.'' While a PCCM may be both a managed care 
entity and a PAHP, if it is paid on a risk basis, it would only be 
subject to this provision based on its status as a ``managed care 
entity'' under section 1932 of the Act, rather than its status as a 
PAHP. In this paragraph, we proposed to add PCCM entities consistent 
with the discussion of PCCM entities in the opening paragraph of this 
section of this final rule, and with the fact that the definition of 
managed care entity includes a PCCM.
    In Sec.  438.702(a)(4), we proposed to delete the phrase ``after 
the effective date of the sanction,'' and insert ``after the date the 
Secretary or the State notifies the MCO or PCCM of a determination of a 
violation of any standard under sections 1903(m) or 1932 of the Act.'' 
The proposed language is identical to the statutory standard in section 
1932(e)(2)(D) of the Act; we believed that the current language did not 
fully reflect the statutory directive.
    In Sec.  438.706, we proposed a change to correct an inconsistency. 
Currently, Sec.  438.706 discusses special rules for temporary 
management and, in paragraph (a), we reference ``onsite survey, 
enrollee complaints, financial audits, or any other means'' as 
acceptable ways to determine if an MCO must be subjected to temporary 
management. However, this language is inconsistent with language at 
Sec.  438.700(a) that references ``onsite surveys, enrollee or other 
complaints, financial status, or any other source'' as a means to 
determine imposable sanctions. We proposed to correct this 
inconsistency by revising Sec.  438.706(a) to incorporate the language 
of Sec.  438.700(a).
    In Sec.  438.724(a), we proposed to delete the reference to 
``Regional Office,'' consistent with proposed changes in Sec.  438.3(a) 
and Sec.  438.7(a).

[[Page 27611]]

    We also proposed changes to update terms. For instance, Sec.  
438.730 currently addresses sanctions imposed by CMS on MCOs and 
paragraphs (e)(1) and (e)(2) use the term ``HMO.'' The Balanced Budget 
Act of 1997 (BBA) replaced the term ``Health Maintenance Organization 
(HMO)'' with ``Managed Care Organization (MCO).'' We proposed to 
correct these obsolete references to HMO in paragraphs (e)(1) and (2) 
by replacing the term with ``MCO.'' In addition, current Sec.  438.730 
uses ``State agency'' or ``agency,'' which is inconsistent with 
references to the state in subpart H as well as our proposal to create 
a uniform definition for ``state'' in Sec.  438.2. We therefore 
proposed revisions to address this.
    We also proposed to correct several inaccurate cross-references to 
other provisions of the regulations text. In Sec.  438.730(f)(1), the 
reference to ``paragraph (b)'' would be revised to reference 
``paragraph (c).'' In Sec.  438.730(f)(2)(i) and (ii), the reference to 
``(d)(2)(ii)'' would be revised to reference ``(d)(2)'' and the 
reference to ``(c)(1)(ii)'' would be revised to reference 
``(d)(1)(ii).'' Finally, in Sec.  438.730(g)(1), the reference to 
``paragraph (c)(1)(i)'' would be revised to reference ``paragraph 
(c)(1).''
    We received the following comments in response to our proposal to 
revise Sec. Sec.  438.700, 438.702, 438.704, 438.706, 438.708, 438.722, 
and 438.730.
    Comment: A few commenters objected to the proposed change in Sec.  
438.700(a) to permit states the option to establish intermediate 
sanctions for MCOs and requested clarification as to whether the 
intermediate sanctions in Sec.  438.702 represent an exclusive list of 
sanctions for states to consider for conduct specified in Sec.  
438.700(b) through (d). A commenter also stated that the imposition of 
intermediate sanctions should be required. A commenter also noted that 
the proposed change to replace ``must'' with ``may'' in Sec.  
438.700(a) that was discussed in the preamble of the proposed rule at 
80 FR 31132 did not appear in the regulatory text.
    Response: The basis for imposition of sanctions in Sec.  438.700 is 
based on section 1932(e)(1) of the Act that states that a state may not 
enter into or renew a contract under section 1903(m) unless the State 
has established intermediate sanctions, which may include any of the 
types (set forth in Sec.  438.702). The plain language of section 
1932(e)(1) of the Act requires states to have intermediate sanctions in 
place before entering into or renewing a contract with an MCO and we 
will retain the use of ``must'' in reference to states having 
intermediate sanctions in place for MCOs. However, the statute does not 
require that the state have the specific intermediate sanctions that 
are listed in section 1932(e)(2) of the Act and repeated in regulation 
at Sec.  438.702; the statute provides that a state's intermediate 
sanctions ``may include'' sanctions of the type listed in section 
1932(e)(2) of the Act. We direct the commenter to the parenthetical in 
Sec.  438.702(a), which is new text proposed in our proposed rule and 
finalized here; that parenthetical does not appear in the current 
regulation text at Sec.  438.700(a) and provides states with the 
flexibility as to the intermediate sanctions that are adopted. To be 
consistent with the statute, we will retain the parenthetical in Sec.  
438.700(a) that the intermediate sanctions that must be in place for a 
state to contract with MCOs (and may be in place for the state to 
contract with PCCMs or PCCM entities) may include those specified in 
Sec.  438.702 to reflect the statutory requirement in section 
1932(e)(1) of the Act.
    Regarding comments whether the state has the option to impose 
intermediate sanctions upon a determination that an MCO, PCCM, or PCCM 
entity acted or failed to act as specified in Sec.  438.700(b) through 
(d), section 1932(e)(1) and (2) of the Act clearly permits state 
flexibility as to the decision to impose a sanction and as to the 
appropriate sanction. The state, as the direct contractor with the MCO, 
PCCM, or PCCM entity, is in the best position to determine if the 
imposition of intermediate sanctions is warranted. If a state 
determines that the imposition of intermediate sanctions is 
appropriate, it may select from the options in Sec.  438.702 or use 
others in place through the contract with the MCO, PCCM, or PCCM 
entity. We note that Sec.  438.702(b) specifies that states retain the 
authority to impose additional sanctions for the areas of noncompliance 
in Sec.  438.700, as well as additional areas of noncompliance. For the 
most part, the state has the discretion to choose which of these 
intermediate sanctions to use. However, the state is required to have 
authority to appoint temporary management under section 1932(e)(2)(B) 
of the Act, and to permit individuals to terminate without cause under 
section 1932(e)(2)(C) of the Act. This is because section 1932(e)(3) of 
the Act requires the state to impose at least those two sanctions if an 
MCO repeatedly fails to meet the requirements of section 1903(m) or 
1932 of the Act. This requirement is specified at Sec.  438.706(b).
    Comment: A commenter suggested that since Sec.  438.700(a) provides 
that a state may impose intermediate sanctions if it makes any of the 
determinations specified in paragraphs (b) through (d), the use of 
``whether'' in those paragraphs is confusing and does not clearly link 
a determination of wrongdoing with the option of imposing an 
intermediate sanction. The commenter suggested replacing ``whether'' 
with ``that'' in the relevant paragraphs of Sec.  438.700.
    Response: We agree with the commenter's suggestion to clarify the 
language in Sec.  438.700(b) through (d) by replacing ``whether'' with 
``that'' to clarify the intent of the section.
    Comment: A commenter asked for clarification if the proposed 
deletion of PIHPs and PAHPs from Sec.  438.700(c) for violations of 
marketing rules in Sec.  438.104 meant that such violations by PIHPs or 
PAHPs could be subject to intermediate sanctions.
    Response: States may cover PIHPs and PAHPs under their own sanction 
laws and we encourage them to do so whenever they believe necessary.
    Comment: A commenter supported the proposed change in Sec.  
438.702(a)(4) that the suspension of new enrollment applies ``after the 
date the MCO is notified of a determination of violation'' to match the 
statutory standard in section 1932(e)(2)(D) of the Act.
    Response: We appreciate the commenter's support for this proposed 
change and are finalizing without further modification.
    Comment: A commenter asked for clarification as to the meaning of 
``each determination'' in Sec.  438.704 to determine the total amount 
of the civil monetary penalty. The commenter asked if the phrase should 
be interpreted to mean ``each individual'' case or if ``several 
individual cases reviewed at the same time'' would constitute a single 
determination.
    Response: We appreciate the commenter's request for clarification 
of ``each determination'' and conclude that the phrase, which is 
incorporated in regulation from section 1932(e)(2)(A) of the Act, means 
each individual case that supports the state's finding of an MCO's, 
PCCM's, or PCCM entity's act or failure to act under Sec.  438.700(b) 
through (d).
    Comment: One commenter stated that the amounts for civil monetary 
penalties in Sec.  438.704 should be left to the states to determine 
and another commenter recommended that the amounts for civil monetary 
penalties be increased.
    Response: The specific limits for civil monetary penalties in Sec.  
438.704(b) and (c) are set forth in section 1932(e)(2)(A) of the Act 
and cannot be altered without statutory modification. Under Sec.  
438.704(a), if a state imposes civil monetary penalties as provided 
under

[[Page 27612]]

S438.702(a)(1), the maximum amount of the civil monetary penalties per 
type of violation are set forth in paragraphs (b) and (c).
    Comment: A commenter requested that CMS define the term 
``egregious'' in Sec.  438.706(a)(1) relating to the state's 
discretionary imposition of temporary management of an MCO.
    Response: We decline to explicitly define ``egregious'' in this 
context because it is a substantive determination by the state whether 
the MCO's conduct merits the imposition of temporary management. We did 
identify a necessary technical correction in Sec.  438.706(a). The 
reference to the intermediate sanction in Sec.  438.702(a)(3) has been 
corrected to Sec.  438.702(a)(2).
    Comment: A commenter suggested that the notice process for 
temporary management of an MCO in Sec.  438.706 was unnecessary because 
states generally have laws and regulatory processes for regulatory 
management of an MCO.
    Response: The notice requirement in Sec.  438.706(b) pertains to 
notifying enrollees of their right to terminate enrollment without 
cause as provided in Sec.  438.702(a)(3) rather than a notification 
process to the MCO. We believe that such notification to enrollees is 
reasonable and necessary to provide enrollees with the opportunity to 
make decisions that are in their best interests.
    Comment: A commenter suggested that the notice and appeal process 
for sanction or termination of an MCO in Sec.  438.710 was duplicative 
of existing state laws and regulatory processes for such actions and 
should be modified or removed.
    Response: The provision in Sec.  438.710(a) for written notice of 
the imposition of an intermediate sanction to the affected entity 
containing the basis and nature of the sanction and any other appeal 
rights that the state elects to provide is based on section 1932(e)(5) 
of the Act and cannot be modified by regulation. We note that Sec.  
438.710(a)(2) provides states the discretion whether additional hearing 
or appeal rights are provided to the affected entity. The requirement 
in Sec.  438.710(b) for a pre-termination hearing is similarly 
specified in statute at section 1932(e)(4) of the Act and cannot be 
modified by regulation.
    Comment: One commenter believed that Sec.  438.726, which requires 
the state plan to include a plan for monitoring violations that involve 
the actions and failures to implement the provisions of this part, was 
burdensome as it would require an amendment for every modification to 
an approach that should be dynamic.
    Response: We disagree. The state plan page for Sec.  438.726 
requires high level information verifying that the state has a 
monitoring plan in place for the actions or inactions by MCOs, PCCMs 
and PCCM entities in Sec.  438.700, specifying a threshold to be met 
before an MCO is considered to have repeatedly committed violations of 
section 1903(m) of the Act, and thus, be subject to the imposition of 
temporary management, and confirms compliance with Sec.  438.726(b). 
Specific detail on the monitoring plan or detail on additional types of 
intermediate sanctions is not required and the state is under no 
obligation to update the state plan page to reflect such practices.
    Comment: One commenter requested that CMS clarify in Sec.  438.730 
(that is, sanction of an MCO by CMS), which entity (the state or CMS) 
the MCO would submit a request for an extension in paragraph (c)(3) and 
which entity (the state or CMS) would make a determination as to the 
credibility of the MCO's request for an extension in paragraph 
(c)(3)(i).
    Response: We appreciate the commenter's request for clarification. 
Paragraph (c) provides that the state's determination becomes CMS' 
determination under paragraph (b)(2) if the state takes the actions 
specified in that paragraph. Therefore, the MCO would submit the 
request for an extension to the state and the state would determine 
whether to grant the 15-day extension based on the state's 
determination that the MCO provided a credible explanation for 
additional time. The extension would ultimately be granted by the state 
if CMS, upon receipt of the request for an extension before the 
expiration of the initial 15-day period, determines that the MCO's 
conduct does not pose a threat to an enrollee's health or safety. We 
believe this is clear from the regulatory text and will rely on this 
explanation as the requested clarification.
    After consideration of the public comments, we are finalizing Sec.  
438.700 with the modifications to replace ``whether'' with ``that'' in 
paragraphs (b), (c) and (d) as described above but otherwise as 
proposed. We are finalizing, as proposed, Sec. Sec.  438.702, 438.704, 
438.706, 438.708, 438.710, 438.722, 438.724, 438.726 and 438.730; in 
Sec.  438.704(b), Sec.  438.706(a), and Sec.  438.730(a) we are also 
finalizing minor technical corrections to cross-referenced cites.
e. Deferral and/or Disallowance of FFP for Non-Compliance With Federal 
Standards (Sec.  438.807)
    We proposed to add a new Sec.  438.807 to specify that we may defer 
and/or disallow FFP for expenditures under a MCO contract identified in 
section 1903(m)(2)(A) of the Act when the state's contract, as 
submitted for our approval or as administered, is non-compliant with 
standards therein, with section 1932 of the Act, or with the provisions 
of 42 CFR part 438 implementing such standards. These standards include 
whether final capitation rates, as specified in the contract and 
detailed in the rate certification, are consistent with the standards 
of actuarial soundness proposed in Sec. Sec.  438.4 through 438.7. The 
proposed process for issuance of a deferral or a disallowance is the 
same as the process identified in Sec. Sec.  430.40 and 430.42, 
respectively.
    Section 1903(m)(2)(A) of the Act specifies that if the requirements 
set forth in paragraphs (i) through (xiii) therein are not satisfied, 
no FFP is authorized for expenditures incurred by the state for 
services under a prepaid capitation or other risk-based contract under 
which the payment is for inpatient hospital services and any other 
service described in paragraphs (2), (3), (4), (5), or (7) of section 
1905(a) of the Act, or for the provision of any three or more of the 
services described in such paragraphs. We have previously interpreted 
this to mean that if the state fails to comply with any of the listed 
conditions, there could be no FFP at all for payments under the 
contract, even for amounts associated with services for which there was 
full compliance with all requirements of section 1903(m)(2)(A) of the 
Act. This interpretation has resulted in a potential penalty that in 
some cases appears to be out of proportion to the nature of the 
violation, under which FFP would be withheld for payment amounts 
representing services which are in compliance.
    We proposed to interpret section 1903(m)(2)(A) of the Act that the 
enumerated services are for purposes of defining the minimum scope of 
covered services under a comprehensive risk, or MCO, contract. We 
proposed that deferrals and/or disallowances of FFP can be targeted to 
all services under the MCO contract even if not listed explicitly in 
section 1903(m)(2)(A) of the Act, rather than FFP in the full payment 
amount made under the contract. Specifically, we proposed in Sec.  
438.807 to interpret section 1903(m)(2)(A) of the Act to condition

[[Page 27613]]

FFP in contract payment amounts on a service by service basis, so that, 
for example, if the violation involved the payment amount associated 
with coverage of inpatient hospital costs and that is the only portion 
of the payment amount that is not actuarially sound, then FFP in only 
that portion of the payment would be deferred or disallowed. We argued 
that this approach was supported as the language reads no payment shall 
be made under this title to a State with respect to expenditures 
incurred by it for payment for services provided by any entity as 
placing emphasis on ``payment for services provided by any entity'' 
without regard to what the services are, so long as the minimum scope 
of covered services for a MCO contract is satisfied. Under the 
proposal, we would have deferred and/or disallowed partial FFP under 
the contract associated with only a particular service category if a 
violation involves only that category of services and not the delivery 
of services generally.
    We received the following comments in response to our proposal to 
add Sec.  438.807.
    Comment: Many commenters supported proposed Sec.  438.807 and 
recommended additional clarification. One commenter recommended that 
CMS clarify whether it retains the authority to withhold all FFP due to 
non-compliance, or if CMS is only able to withhold FFP on a service by 
service basis. One commenter recommended that CMS use such authority to 
penalize managed care plans that do not meet the network adequacy and 
access to care standards.
    One commenter stated that none of the requirements listed in 
section 1903(m)(2)(A) of the Act support CMS' approach in Sec.  
438.807. The commenter stated that section 1903(m)(2)(A)(iii) of the 
Act contains the requirement that capitation rates be actuarially 
sound, and this concept does not allow CMS to isolate and remove 
portions of capitation rates to be paid for individual services, 
without affecting the certification of the rate as adequate to meet the 
needs of contracting plans. The commenter also stated that the 
remaining federal Medicaid managed care requirements in section 
1903(m)(2)(A) of the Act are established as obligations imposed on 
states for inclusion in their contracts with Medicaid plans, not as 
requirements applicable to individual services. The commenter stated 
that it is unclear when and under what basis, CMS would be able to 
conclude that a violation involves only a particular category of 
service. Other commenters opposed to Sec.  438.807 stated that CMS' 
approach to defer or disallow FFP for targeted services is incongruent 
with the operation of Medicaid managed care programs and inconsistent 
with a comprehensive full-risk managed care contract and capitated 
payment model.
    Response: After consideration of public comments and 
reconsideration of the statutory text, we have determined that section 
1903(m)(2)(A) of the Act does not permit us the flexibility to take 
partial deferral or disallowance of FFP under the contract as proposed. 
Therefore, we will not finalize proposed Sec.  438.807.
    We are not finalizing Sec.  438.807.
f. Exclusion of Entities (Sec.  438.808)
    Current Sec.  438.808 implements the requirements of section 
1902(p)(2) of the Act with respect to MCOs. Section 1902(p) of the Act 
enforces exclusions from federal health care programs by prohibiting 
FFP for medical assistance to MCOs and entities furnishing services 
under a waiver approved under section 1915(b)(1) of the Act if the MCOs 
or entities that have a contractual or other relationships with 
excluded entities or individuals. We proposed to clarify that PIHPs, 
PAHPs, PCCMs or PCCM entities that have contracts with the state under 
a section 1915(b)(1) waiver would also be subject to Sec.  438.808, 
which implements the requirements in section 1902(p)(2) of the Act for 
the types of organizations or entities with which the state must not 
contract in order for the state to receive federal payments for medical 
assistance. Section 1902(p)(2) of the Act similarly provides that an 
entity furnishing services under a waiver approved under section 
1915(b)(1) of the Act must meet the exclusion parameters identified in 
section 1902(p)(2)(A), (B) and (C) of the Act in order for the state to 
receive FFP. The regulation, at Sec.  438.808(b), lists the entities 
that must be excluded. There is no requirement in the statute that MCO 
contracts be tied to a specific managed care authority so we proposed 
that all MCO contracts under any authority be subject to this 
provision.
    We received the following comments in response to our proposal to 
revise Sec.  438.808.
    Comment: One commenter supported the addition of PIHPs, PAHPs, 
PCCMs, and PCCM entities that operate under a waiver approved under 
section 1915(b)(1) of the Act.
    Response: We appreciate the comment as the proposed change is 
consistent with section 1902(p)(2) of the Act.
    Comment: One commenter pointed out that Sec.  438.808(b)(2) does 
not reference individuals or entities that are excluded from 
participation in any federal health care program under section 1128 or 
1128A of the Act as set forth in Sec.  438.610(b).
    Response: We appreciate the commenter's identification of this 
omission. Section 438.808 is based on section 1902(p)(2) of the Act and 
includes individuals or entities excluded from participation under 
sections 1128 or 1128A of the Act; therefore Sec.  438.808(b)(2) and 
(b)(3)(i) and (ii) should also include a reference to Sec.  438.610(b). 
The distinction between individuals or entities in Sec.  438.610(a) and 
(b) is for purposes of distinguishing whether the ``knowingly'' 
standard applies.
    After consideration of the public comments, we are finalizing this 
section as proposed with a modification to include appropriate 
references to Sec.  438.610(b).
5. Beneficiary Protections
a. Enrollment (Sec.  438.54)
    In this section, we addressed a gap in the current managed care 
regulations regarding the enrollment process. Other than the default 
enrollment standards currently in Sec.  438.50(e) and (f) for MCOs and 
PCCMs, there have been no federal regulations governing enrollment of 
beneficiaries into Medicaid managed care programs. In the absence of 
specific federal regulatory provisions, states have used a number of 
different approaches to enrolling beneficiaries into voluntary and 
mandatory managed care programs. The variation in proposed processes 
revealed a need for guidance to ensure an appropriate, minimum level of 
beneficiary protection and consistency across programs. In this 
section, we proposed basic federal standards for enrollment while 
continuing to permit state flexibility in designing enrollment 
processes for Medicaid managed care programs.
    Among states currently operating voluntary Medicaid managed care 
programs, which allow each beneficiary to choose to receive services 
through either a managed care or FFS delivery system, states have 
generally used a passive enrollment process to assign a beneficiary to 
a managed care plan immediately upon being determined eligible. 
Typically, the beneficiary is provided a period of time to elect to 
opt-out of enrollment from the state-assigned managed care plan and 
select a different managed care plan or elect to opt-out of managed 
care completely and, instead, receive services through a FFS delivery 
system. If the beneficiary does not make an affirmative choice, the

[[Page 27614]]

beneficiary remains enrolled in the state-assigned managed care plan 
during the period of Medicaid eligibility and enrollment. Our 
experience shows the rate of potential enrollees that opt-out is 
generally very low.
    In a mandatory Medicaid managed care program, states require 
beneficiaries to receive Medicaid benefits from managed care plans. 
Under section 1932(a)(4)(A)(ii)(I) of the Act, beneficiaries in a 
mandatory managed care program have the right to change plans without 
cause within 90 days of enrolling in the plan and every 12 months; 
enrollees may also change plans for cause at any time. When the 
beneficiary does not actively select a managed care plan in the 
timeframe permitted by the state, states have generally used the 
default assignment process to assign individuals into plans. Section 
1932(a)(4)(D) of the Act and current implementing regulations at Sec.  
438.50(f) outline the process that states must follow to implement 
default enrollment (also commonly known as auto-assignment) in a 
mandatory managed care program.
    In both voluntary and mandatory managed care programs, we suggested 
that beneficiaries are best served when they affirmatively exercise 
their right to make a choice of delivery system or plan enrollment. We 
noted that this involves both an active exercise of choice and 
requisite time and information to make an informed choice. Further, 
given the sensitive nature of this transition from FFS to managed care 
or from one managed care system to a new managed care system and the 
often complex medical, physical and/or cognitive needs of Medicaid 
beneficiaries, we indicated that enrollment processes should be 
structured to ensure that the beneficiary has an opportunity to make an 
informed choice of a managed care plan and that state processes support 
a seamless transition for an enrollee into managed care.
    Our goal of alignment prompted us to consider how enrollment is 
conducted in the private market and in other public programs. In the 
proposed rule, we noted that MA is a voluntary managed care program, in 
which beneficiaries actively select the MA organization during the 
annual open enrollment period with limited exceptions for passive 
enrollment. To promote integration of care for dually eligible 
(Medicare and Medicaid) beneficiaries in a section 1115A demonstration, 
CMS' Medicare-Medicaid Coordination Office (MMCO) is using a form of 
passive enrollment. That enrollment process generally requires 
notifying dually eligible individuals that they can select a Medicare 
plan 2 months before they would be enrolled in the plan. If no active 
choice is made, enrollment into the plan identified through the passive 
process takes effect.
    We also noted that enrollment into a QHP in either the FFM or SBM 
requires an active selection of a plan, and in some cases premium 
payment. The online application for the FFM at Healthcare.gov provides 
the option to select a QHP at the time of application. If a QHP is not 
selected at the time of application, the FFM single, streamlined 
application requires follow-up by the individual to complete enrollment 
into a QHP. A few states with mandatory Medicaid managed care programs 
require applicants to select a Medicaid managed care plan at the time 
of application. While this approach aligns the processes for Medicaid, 
CHIP and QHPs, it also eliminates the traditional approach of providing 
a post-eligibility determination choice period to select a managed care 
plan for Medicaid beneficiaries already eligible for FFS coverage.
    We proposed a new Sec.  438.54 to apply a consistent standard for 
all managed care enrollment processes. At the same time, we proposed to 
move and revise, as noted below, the existing provisions in Sec.  
438.50(e) and (f) to our new Sec.  438.54. Under these proposed 
changes, states would implement enrollment processes subject to a set 
of enrollment standards that are consistent with section 1932(a)(4) of 
the Act and that promote high quality managed care programs. The goals 
of this approach were to promote accurate and timely information to 
beneficiaries about their managed care options; to enable and encourage 
active beneficiary choice periods for enrollment; and to ensure the 
state's ability to conduct intelligent default enrollments into a 
managed care plan when necessary.
    Through the changes discussed below, we proposed to set broad 
parameters for a state's enrollment process rather than dictate 
specific elements. In paragraph Sec.  438.54(a), we proposed to clarify 
that the provisions of this section apply to all authorities under 
which a state may enroll beneficiaries into a managed care delivery 
system to ensure a broad and consistent application. We noted that this 
includes voluntary managed care programs under section 1915(a) of the 
Act, as well as mandatory or voluntary programs under sections 1932(a), 
1915(b) or 1115(a) of the Act.
    We proposed in paragraph (b) that the state have an enrollment 
system for both voluntary and mandatory managed care programs, and 
proposed definitions for those programs in, respectively, paragraphs 
(b)(1) and (b)(2). These proposals supported clarity and consistency.
    Proposed paragraph (c) specified the standards for programs using a 
voluntary managed care program. In paragraph(c)(1), we proposed that 
the state may use either an enrollment system that provides the 
beneficiary time to make an affirmative election to receive services 
through a managed care or FFS delivery system or a passive enrollment 
process. We proposed to define a passive enrollment process as one in 
which the State selects a MCO, PIHP, PAHP, PCCM, or PCCM entity for a 
potential enrollee but provides a period of time for the potential 
enrollee to decline the managed care plan selection before enrollment 
became effective. Using either option, the state would have had to 
comply with the standards proposed in paragraphs (c)(2) through (c)(8).
    In paragraph (d), we proposed to set forth standards for enrollment 
systems for mandatory managed care programs. In paragraph (d)(1), we 
proposed that such a system must meet certain standards, listed in 
proposed paragraphs (d)(2) through (d)(7). We discussed the remaining 
proposals for paragraphs (c) and (d) together below as these proposed 
standards were substantially similar.
    In paragraph (c)(2) and (d)(2), we proposed a specific enrollment 
standard applicable to both voluntary and mandatory managed care 
programs that all states must provide a period of time of at least 14 
calendar days of FFS coverage for potential enrollees to make an active 
choice of their managed care plan. We explained that the minimum 14-
calendar day period would have had to occur between the date that the 
notice specified in paragraph (c)(3) and (d)(3) is sent and the date on 
which the enrollee becomes covered under the applicable managed care 
entity.
    We proposed to clarify in paragraph (c)(2)(i), that if the state 
does not use a passive enrollment process and the potential enrollee 
does not make a choice, then the potential enrollee would have been 
enrolled into a managed care plan selected by the state's default 
process when the choice period has ended. We did not propose that 
states must use FFS as the default enrollment when using a voluntary 
managed care program; rather FFS enrollment could be limited to those 
beneficiaries that affirmatively selected FFS. In proposed paragraph 
(c)(2)(ii), we clarified that if the state used a passive

[[Page 27615]]

enrollment process and the potential enrollee does not make a choice, 
then the potential enrollee is enrolled into the managed care plan 
selected by the state's passive enrollment process when the choice 
period has ended. In the mandatory program, the minimum 14-day period 
would have to occur before any default enrollment process is used. We 
did not propose any passive enrollment mechanism for mandatory managed 
care programs because the default enrollment mechanism would provide 
the same measure of administrative flexibility.
    We acknowledged that states may want to effectuate plan enrollment 
in mandatory programs as soon as possible after the eligibility 
determination. Our proposal would have required those states to provide 
a period of FFS coverage for beneficiaries between their date of 
eligibility and their date of managed care enrollment. To minimize any 
further delay in managed care enrollment, we proposed to allow states 
to operationalize the 14-day active choice period by advising 
beneficiaries of the managed care plan they would be enrolled into 
through the default process if they do not make an active choice of 
managed care plan in that 14-day period. According to this process, 
states would complete the default enrollment process outlined in Sec.  
438.54(d)(5) prior to beginning the notice and education process 
described in paragraph (d)(3) with beneficiaries, and ensure that 
adequate and appropriate information is provided to beneficiaries 
regarding the implications of not making an active managed care plan 
selection. This proposal would also have enabled beneficiaries to 
override default enrollments by exercising their ability to make an 
active choice of a managed care plan.
    We requested comment on the impact of this new standard on managed 
care program costs and operations, as well as the operational 
flexibility we proposed to relieve beneficiaries of the burden of 
receiving too many mailings, which can create confusion, before making 
the default enrollment permitted in Sec.  438.54. We also invited 
comment on whether a 14-day period is necessary, provides sufficient 
time for beneficiaries to make an election, or whether a longer minimum 
period, such as 30 days or 45 days, should be adopted.
    All beneficiaries, regardless of whether enrollment is mandatory or 
voluntary, must be given the information, education, and opportunity to 
participate actively in their choice of managed care plan. Paragraphs 
(c)(3) and (d)(3) proposed that states develop informational notices to 
clearly explain to the potential enrollee the implications of not 
actively making the decisions available to them and allowing the 
passive or default enrollment to take effect. Proposed paragraphs 
(c)(3)(i) and (d)(3)(i) provided that the notices comply with Sec.  
438.10 and proposed paragraphs (c)(3)(ii) and (d)(3)(ii) provided that 
the notices have a postmark or electronic date stamp that is at least 3 
calendar days prior to the first day of the 14-day choice period. We 
believed these proposed provisions established reasonable time for 
either postal delivery or the potential enrollee to read the electronic 
communication and still have 14 days to make an active selection.
    Priority for enrollment into a managed care plan is currently in 
Sec.  438.50(e); however, for better organization, we proposed to 
delete the text from Sec.  438.50 and proposed it as paragraphs (c)(4) 
and (d)(4). No other changes were proposed to this text regarding 
priority for enrollment.
    We proposed in paragraphs (c)(5) and (d)(5) that states assign 
potential enrollees to a qualified MCO, PIHP, PAHP, PCCM, or PCCM 
entity. This concept is currently addressed in Sec.  438.50(f)(2) but 
only to the extent of excluding those MCOs and PCCMs that are subject 
to the intermediate sanction in Sec.  438.702(a)(4). In proposed 
(c)(5)(i) and (d)(5)(i), we proposed to exclude MCOs, PIHPs, PAHPs, 
PCCMs, or PCCM entities subject to sanction under Sec.  438.702(a)(4) 
and to add paragraphs (c)(5)(ii) and (d)(5)(ii) to ensure that a MCO, 
PIHP, PAHP, PCCM, or PCCM entity has the capacity for new enrollments 
as a condition of being qualified to accept assigned enrollments.
    In proposed paragraphs (c)(6) and (d)(6), we addressed standards 
that are currently reflected in Sec.  438.50(f) which provides that 
states have a default enrollment process for assigning a MCO or PCCM 
when the potential enrollee does not make an active managed care plan 
selection. Section 1932(a)(4)(D) of the Act provides that a state 
conduct such enrollments in a manner that takes existing provider-
individual relationships into consideration, and if that approach is 
not possible, to equitably distribute individuals among the 
participating managed care plans. While the 2002 final rule strictly 
interpreted the provisions of section 1932(a)(4)(D) of the Act 
regarding default enrollment to apply only to enrollment that occurred 
under state plan authority in section 1932(a) of the Act, we noted our 
belief that the enrollment processes currently specified in Sec.  
438.50(e) and (f) should not be limited only to entities subject to 
section 1932(a)(4)(D) of the Act. Allowing potential enrollees 
sufficient time to make informed decisions about their managed care 
plan is an important protection that should not exclude potential 
enrollees of PIHPs and PAHP, as well all those subject to voluntary 
programs that utilize a passive process. Therefore, we proposed to make 
these provisions applicable to all managed care authorities and to both 
passive and default enrollment processes. We proposed adding existing 
text from Sec.  438.50(f)(2) through (f)(4) in paragraphs (c)(6) and 
(d)(6). While Sec.  438.50(f) currently only applies to default 
enrollment in mandatory managed care programs, we stated that enrollees 
in voluntary programs that utilize a passive enrollment process should 
also benefit from being assigned to a plan based on existing provider 
relationships or other criteria relevant to beneficiary experience. 
Therefore, we proposed to add standards in paragraph (c)(6) for 
voluntary programs that mirrored the standards for mandatory programs 
using default enrollments.
    In paragraphs (c)(7) and (d)(7), we proposed to include provisions 
from existing Sec.  438.50(f)(2) that provide that if a state cannot 
preserve existing provider-beneficiary relationships and relationships 
with providers that traditionally serve Medicaid, then enrollees must 
be equitably distributed. Paragraphs (c)(7)(i) and (d)(7)(i) proposed a 
standard that states may not arbitrarily exclude a MCO, PIHP, PAHP, 
PCCM, or PCCM entity from the assignment process. We proposed 
interpreting ``equitable distribution'' in section 
1932(a)(4)(D)(ii)(II) of the Act to mean not only that the criteria 
applied to make default enrollments are fair and reasonable for 
enrollees and plans, but that the pool of contractors eligible to 
receive default enrollments is not based on arbitrary criteria. We also 
proposed to allow the flexibility to use additional criteria related to 
the beneficiary when making default assignments, such as the geographic 
location of the beneficiary, enrollment preferences of family members, 
previous plan assignment of the beneficiary, quality assurance and 
improvement performance, procurement evaluation elements, and other 
reasonable criteria that support the goal of the Medicaid program, 
should be provided for in the regulation. We proposed that such 
criteria be part of an equitable distribution by ensuring fair 
treatment for enrollees and managed care plans.
    For voluntary programs only that use passive enrollment, paragraph 
(c)(8)

[[Page 27616]]

proposed that states send confirmation notices to enrollees of their 
plan selection that contain information explaining the enrollee's right 
to disenroll from that MCO, PIHP, PAHP, PCCM, or PCCM entity within 90 
days. We noted that many states use a voluntary model when first 
starting to introduce managed care, which means the beneficiaries are 
not as familiar with the limitations of managed care plan enrollment; 
we believed that the additional confirmation notice would help limit 
unintended plan selections before they take effect.
    We received the following comments in response to our proposal to 
add a new Sec.  438.54 with these provisions.
    Comment: Many commenters supported the enrollment provisions 
proposed in Sec.  438.54. Commenters supported having all enrollment 
information in one section and the increased information provided on 
topics previously not addressed in part 438, such as mandatory and 
voluntary enrollment.
    Response: We thank the commenters for their support of the 
organization and clarity of the proposed Sec.  438.54 and of the 
proposal to provide increased direction and details on critical 
enrollment processes and policies.
    Comment: A few commenters recommended that when potential enrollees 
are provided the opportunity to make an active choice of a managed care 
plan (in both voluntary and mandatory programs) and do not make a 
choice, that the enrollees should be automatically placed in the FFS 
delivery system. We also received a few comments recommending that 
passive enrollment, default assignment, and mandatory enrollment be 
prohibited. These commenters believed that all potential enrollees 
should only be enrolled into a managed care plan after making an active 
choice.
    Response: We decline to make these changes. Mandatory enrollment- 
for specified populations- and default enrollment are permitted 
statutorily in sections 1932(a)(1)(A), 1915(b), 1932(a)(4)(D) of the 
Act. Passive enrollment, while not statutorily defined, is an 
enrollment mechanism used to more quickly provide the additional 
benefits, provider network, and care coordination services generally 
only available through managed care. Passive enrollment processes have 
been used successfully in many states. Additionally, states using a 
passive enrollment process must still fulfill the intent of a voluntary 
program by offering enrollees time to elect to remain in managed care 
or to move to the state's FFS delivery model. In addition, if the 
enrollee elects to remain in managed care, the enrollee has at least 90 
days from the date of enrollment in the managed care plan, as provided 
in Sec.  438.56(c)(2)(i), to decide whether to remain in the assigned 
plan or to select a different managed care plan. Enrollees can also 
avail themselves of the for-cause reasons specified in Sec.  438.56 
after the 90 day period has ended. We believe there are adequate 
protections in place in programs using passive enrollment to warrant 
their continuation.
    Comment: A few commenters recommended that CMS mandate exemptions 
from mandatory managed care plan enrollment for enrollees in a current 
course of care and enrollees with complex conditions such as pregnancy. 
The commenters believed mandating these types of enrollees into managed 
care could be disruptive and harmful.
    Response: We do not believe that mandating such an exemption from 
mandatory enrollment is necessary or within our authority. Section 
1932(a) of the Act provides for the exclusion of certain populations 
(certain children with special health care needs, Medicare recipients, 
and Indians) from mandatory enrollment, unless permitted under another 
authority, as discussed in section I.A. of this rule. Beyond these 
exclusions, states have flexibility to design the parameters of their 
managed care programs for mandatory or voluntary enrollment and nothing 
in the final Sec.  438.54 would diminish that flexibility. We believe 
that pregnant enrollees or enrollees with chronic and/or complex 
conditions benefit from the care coordination and additional benefits 
that may be provided through a managed care plan. The provisions of 
this final rule that establish requirements for care coordination and 
continuity of care were designed to promote a smooth transition into 
managed care for beneficiaries with complex health care needs. 
Currently, states have the ability to include this type of exemption 
into their programs and nothing in Sec.  438.54 would diminish that 
flexibility.
    Comment: We received many comments on the proposed 14 day FFS 
choice period in Sec. Sec.  438.54(c)(2) and 438.54(d)(2). Many 
commenters supported this proposed provision as they believe that time 
to make an informed choice is important, particularly for potential 
enrollees with special health care needs or receiving LTSS. Most 
commenters who supported a choice period recommended that the period be 
30 days or longer.
    We also received many comments opposed to the 14 day FFS choice 
period. These commenters believed that putting potential enrollees in 
FFS would be confusing for enrollees and providers; result in 
disruptions of care when FFS providers did not also participate in 
managed care plan networks; and delay enrollees' access to the 
increased benefits, provider network, case management and care 
coordination that come through managed care enrollment. Further, many 
commenters stated that the delay in enrollment under the proposal would 
negatively impact potential enrollees in need of care coordination, 
such as pregnant women, newborns, and individuals recently released 
from incarceration. Several commenters pointed out that due to low or 
no enrollment in their FFS programs over time, implementing a FFS 
period for all new potential enrollees would be difficult, if not 
impossible, for several states. Some commenters stated that these 
challenges would be particularly significant for states with State-
based Marketplaces (SBMs) that were designed to determine eligibility 
for multiple products and facilitate up-front managed care plan 
selection. Commenters also believed that a mandated FFS choice period 
was unnecessary given the 90 day opportunity to change managed care 
plans without cause afforded all enrollees in Sec.  438.56(c)(2)(i), 
the ability to disenroll for cause as specified in Sec.  
438.56(d)(2)(iv), and the accessibility of choice counseling and other 
information through the beneficiary support system proposed in Sec.  
438.71. Lastly, commenters recommended that CMS to leave the decision 
of whether to include a choice period to the states and not mandate a 
one-size-fits-all approach.
    Response: We appreciate the range of comments received on this 
proposed provision. After careful consideration, we have decided not to 
finalize this provision in Sec.  438.54 for voluntary or mandatory 
managed care programs. We agree that there should not be mandated 
barriers in place to timely access to the benefits of managed care, in 
particular, provider networks, care coordination and case management. 
The proposal for a 14 day FFS period prior to managed care enrollment 
did not adequately consider potential disruptions in care and delays in 
accessing care coordination for vulnerable populations such as pregnant 
women, newborns, and individuals released from incarceration. In 
addition, we acknowledge that the proposal was incompatible with the 
direction of state Medicaid programs to effectuate enrollment at the 
point of the eligibility

[[Page 27617]]

determination or soon thereafter. We understand the concerns regarding 
insufficient numbers of providers under FFS in many states and the 
significant difficulty and challenge for states to rebuild FFS programs 
to accommodate the proposed 14 day period. As many commenters stated, 
the 90 day without cause disenrollment window afforded to all enrollees 
in connection with their initial managed care enrollment, serves as a 
choice period. We believe that potential enrollees and enrollees will 
have easier access to information given the provisions in Sec.  438.10 
that require member handbooks, provider directories, and drug 
formularies be publicly available; such information will assist 
enrollees in making an active enrollment choice. We appreciate the 
commenters' recognition of the value of the new for-cause disenrollment 
reason in Sec.  438.56(d)(2)(iv) related to residential, institutional, 
or employment supports for enrollees using LTSS; discussion of this 
provision can be found in section I.B.5.b. We also appreciate the 
support for the beneficiary support system proposed in Sec.  438.71 and 
expect states to implement their beneficiary support systems so that 
they are easily accessible, well publicized, and that they fully 
educate potential enrollees and enrollees on their enrollment and 
disenrollment opportunities and limitations. Additional discussion of 
Sec.  438.71 can be found in I.B.5.c. We clarify that nothing in the 
final Sec.  438.54 prevents or discourages states from providing a 
choice period for some or all populations, if the state believes that 
this option is best suited to the state's programmatic circumstances 
and the needs of the beneficiaries. We believe that continuing the 
flexibility of allowing states to decide whether to include a choice 
period in their program is the best approach. The final regulation text 
at paragraphs (c)(1) and (2) and (d)(2) do not include the 14-day 
choice period; Sec.  438.54, as finalized, will permit states to make 
passive enrollments effective upon eligibility determination, subject 
to the enrollees' right to opt-out or elect a different managed care 
plan. The elimination of the 14-day choice period also necessitated 
revisions to paragraph (d)(2) to clarify enrollment process options 
available to states with mandatory programs; specifically, paragraph 
(d)(2)(i) addresses states that choose to not use a passive enrollment 
process and paragraph (d)(2)(ii) addresses states that choose to use a 
passive enrollment process.
    Comment: One commenter requested clarification on the 
permissibility of using a passive enrollment process as described in 
proposed Sec.  438.54(c)(2)(ii) for a program with only one PCCM 
entity.
    Response: We appreciate the opportunity to clarify that Sec.  
438.54(c)(2)(ii) is applicable to PCCM programs and remind the 
commenter that provisions for programs with single PCCM entities are 
included in proposed Sec.  438.52, specifically, that choice is at the 
PCCM level as with PCCM programs.
    Comment: We received many supportive comments about the 
informational notices proposed in Sec. Sec.  438.54(c)(3) and 
438.54(d)(3). Commenters recommended that the informational notices 
proposed in Sec. Sec.  438.54(c)(3) and 438.54(d)(3) should be written 
at a 6th grade reading level to improve readability and add consistency 
among states; include the contact information for the state's 
beneficiary support system; be consumer tested; be developed by CMS 
rather than the state; and include detailed explanations of the 
implications of selecting a managed care plan given possible lock-in 
enrollment periods and limited for cause disenrollment provisions. We 
also received a few comments recommending that enrollment and 
disenrollment forms be included with the notice.
    Response: We appreciate these comments and agree that adding the 
contact information for the beneficiary support system would be a 
useful addition. We also agree that the informational notices should 
contain a comprehensive explanation of any lock-in enrollment periods, 
as well as, the 90 day without cause disenrollment opportunity and all 
for cause disenrollment reasons in Sec.  438.56. Since, in some cases, 
this notice will be the last one from the state to the enrollee until 
their eligibility redetermination or their annual right to change 
plans, it is critical that this notice be as complete, clear, factual, 
and easy to understand as possible. We are finalizing paragraphs (c)(3) 
and (d)(3) to reflect requirements for when the notice must be sent to 
the enrollee, contact information for the beneficiary support system, 
the length of the enrollment period, and disenrollment rights. In 
paragraphs (c)(3) and (d)(3) in this final rule, we specify new 
requirements for the notices which states a timeframe for sending the 
notices; the implications to the potential enrollee of exercising each 
of the options available; the managed care plans available for 
selection; the process for making the selection know to the state; the 
length of the enrollment period and all disenrollment rights; and 
information on how to contact the beneficiary support system.
    Given the tremendous variation among managed care programs, we 
believe each state, rather than CMS, is in the best position to draft 
these notices. We acknowledge that states and managed care plans 
appreciate the importance of producing easily understood materials and 
have traditionally utilized reading level tools and standards to 
facilitate the production of effective materials. We also believe that 
education and demographic differences across states necessitate 
flexibility and we encourage states to ensure that it, and its managed 
care plans, are producing materials in a grade level that is most 
appropriate for their population. We decline to revise the final rule 
to reflect these recommendations. Given that most enrollment and 
disenrollment is done electronically or by phone, we do not believe 
there is a need to mandate a requirement for including forms with the 
notice; however, states are free to do so if it supports their 
enrollment processes.
    Comment: A few commenters recommended that passive and default 
enrollment be prohibited from managed care plans that do not cover some 
services due to moral or religious objections. We received a few 
comments requesting that CMS add states' ability to suspend passive and 
default enrollment for poorly performing plans. We received one comment 
that states should publish the logic or criteria used to make passive 
and/or default plan assignments.
    Response: We thank commenters for their suggestions but decline to 
add them to Sec.  438.54. These are all options available to the state 
but we do not agree that specifically addressing them in Sec.  438.54 
is necessary. For a managed care plan that does not provide a covered 
service based on moral or religious objections, there are notification 
requirements that it must comply with in Sec.  438.10. This section 
also contains requirements for the state to provide information on how 
and where to obtain the otherwise covered service.
    Comment: One commenter requested clarification on the meaning of 
``qualified'' as used in proposed Sec.  438.54(c)(5) and (d)(5).
    Response: The criteria for ``qualified'' were proposed, and are 
finalized without substantive change, in Sec.  438.54(c)(5)(i) and (ii) 
and (d)(5)(i) and (ii); we made one editorial change to

[[Page 27618]]

add the word ``and'' for additional clarity. The regulation text 
requires two criteria to be met for a MCO, PIHP, PAHP, PCCM or PCCM 
entity to be qualified: (1) Not being subject to the intermediate 
sanction described in Sec.  438.702(a)(4) and (2) Having capacity to 
enroll beneficiaries. We believe both criteria are clear and require no 
further explanation.
    Comment: A few commenters recommended that CMS clarify that 
specialists and hospitals should be considered when a state determines 
an ``existing provider-beneficiary relationship'' in proposed Sec.  
438.54(c)(6)(i) and Sec.  438.54(d)(6)(i). Some other commenters 
recommended that states try to preserve as many existing provider-
beneficiary relationships as possible for an enrollee that utilizes 
multiple services with different providers.
    Response: We understand the commenters' concerns but do not believe 
it is necessary to add reference to specialists or hospitals to the 
text proposed in Sec.  438.54(c)(6)(i) and Sec.  438.54(d)(6)(i) (to be 
finalized in paragraphs (c)(6)(i) and (d)(7)(i) respectively). As 
proposed the relevant text states an existing provider-beneficiary 
relationship is one in which the provider was the main source of 
Medicaid services for the beneficiary during the previous year. 
However, we agree that states should attempt to preserve as many 
existing provider-beneficiary relationships as possible for an enrollee 
and encourage states to review their passive and default algorithms to 
achieve that goal. To clarify this, we are finalizing paragraphs 
(c)(6)(i) and (d)(7)(i) to state in which the provider was a main 
source. This permits complete flexibility to include any provider who 
is a main source of Medicaid services.
    Comment: One commenter recommended that states should be required 
to consult with their managed care plans when determining how to 
equitably distribute enrollees as proposed in Sec. Sec.  
438.54(c)(7)(i) and 438.54(d)(7)(i).
    Response: States are free to consult with their contracted managed 
care plans as they deem appropriate for designing their method for 
equitably distributing enrollees. We do not agree that it should be a 
requirement and, therefore, we decline to revise Sec. Sec.  
438.54(c)(7)(i) and 438.54(d)(7)(i) (to be finalized as Sec.  
438.54(d)(8)(i)).
    Comment: Some commenters suggested criteria that states should have 
to consider in their passive and default enrollment processes in 
addition to those proposed in Sec. Sec.  438.54(c)(7)(ii) and 
438.54(d)(7)(ii). Suggestions included providers serving sub-
populations; languages spoken; and coverage of needed medications. One 
commenter requested clarification on the inclusion of ``accessibility 
of provider offices for people with disabilities (when appropriate)'' 
proposed in the criteria for passive enrollment in Sec.  
438.54(c)(7)(ii) but not in the proposed criteria for default 
assignment in Sec.  438.54(d)(7)(ii).
    Response: The additional criteria suggested by commenters could add 
value to the passive and default enrollment processes and we encourage 
states to utilize additional criteria as they deem appropriate. We 
included other reasonable criteria that support the objectives of the 
managed care program to encourage the use of additional appropriate 
criteria to refine the passive or default enrollment algorithm. 
Therefore, we decline to add the suggested criteria to the final 
regulation text. We appreciate the commenter alerting us to the 
omission in the proposed criteria for default assignment in proposed 
Sec.  438.54(d)(7)(ii); the language ``accessibility of provider 
offices for people with disabilities (when appropriate)'' should have 
been included in both proposed paragraphs. That omission will be 
corrected in the final text at Sec.  438.54(d)(8)(ii).
    Comment: A few commenters recommended extending the confirmation 
notices proposed for voluntary programs that use passive enrollment in 
Sec.  438.54(c)(8) to mandatory programs that utilize passive 
enrollment. Commenters believed that enrollees in mandatory programs 
would benefit from receiving a notice confirming which managed care 
plan they had been enrolled in. Commenters believed this was true even 
if the enrollee made an active plan selection.
    Response: We understand the commenters' recommendation and believe 
the provision as proposed may not have clearly conveyed our intent. In 
a voluntary program that uses passive enrollment, enrollees must first 
decide whether to remain in the managed care delivery system or be 
moved to the FFS delivery system. This is the decision that the notice 
in Sec.  438.54(c)(8) is intended to confirm (that is, that the 
enrollee has failed to elect FFS coverage). We are finalizing paragraph 
(c)(8) with additional text to make the purpose of the notice and the 
deadline for issuing it clearer. As the enrollee in a mandatory managed 
care program is only choosing among managed care plans and does not 
have the option to elect FFS coverage, we believe that it is not 
necessary to require this notice in a mandatory managed care program 
subject to Sec.  438.54(d).
    After consideration of the public comments, we are finalizing Sec.  
438.54 with revisions as follows:
     Paragraph (b), we are finalizing revised introductory text 
to clarify that an enrollment system is required for both voluntary and 
mandatory managed care programs;
     Paragraph (c)(1), we are finalizing text to permit a state 
to provide an enrollment choice period or to use a passive enrollment 
process without mandating a period of FFS coverage, for reasons 
discussed in the comments above;
     Paragraph (c)(2), we are finalizing the regulation text 
without reference to the proposed 14-day choice period with FFS 
coverage (as discussed above) and with minor editorial changes to 
preserve the flow and meaning of the text;
     Paragraphs (c)(3), we are finalizing additional 
requirements for the notice from the state to potential enrollees to 
provide more complete information;
     Paragraphs (c)(5)(i), we are adding ``; and'' to indicate 
that the requirements in both paragraphs must be applied;
     Paragraph (c)(8), we are finalizing revised text to more 
clearly explain the content of the final notice required for voluntary 
programs that use a passive enrollment process and to clarify the 
deadline for that notice;
     Paragraph (d)(2), we are finalizing the regulation text 
without reference to the proposed 14-day choice period with FFS 
coverage (as explained above) and with new text to clarify the 
enrollment process options available in mandatory programs, including 
passive enrollment;
     Paragraph (d)(3), we are finalizing additional 
requirements for the notice from the state to potential enrollees to 
provide more complete information;
     Paragraph (d)(5), we are finalizing the regulation text 
without reference to the proposed 14-day choice period (as explained 
above) and with ``; and'' between paragraphs (i) and (ii) to indicate 
that the requirements in both paragraphs must be applied;
     Paragraph (d)(6), we are finalizing text that clarifies 
requirements for enrollee assignment using a passive enrollment process 
in a mandatory program;
     Paragraph (d)(7) (redesignated from (d)(6)), we are 
revising ``. . . the main source . . .'' to ``. . . a main source . . 
.'' to clarify that multiple existing relationships should be 
maintained in both passive and default enrollment processes if possible 
and making non-substantive revisions to the text to

[[Page 27619]]

acknowledge use of a passive and a default enrollment process;
     Paragraph (d)(8) (redesignated from (d)(7)), we are 
finalizing a conforming change to recognize the redesignation of (d)(7) 
and in paragraph (ii), to include a reference to accessibility for 
disabled enrollees.
b. Disenrollment Standards and Limitations (Sec.  438.56)
    In the proposed rule, we proposed to retain the majority of the 
regulation text currently in Sec.  438.56, with four substantive 
exceptions:
     We proposed, as discussed in more detail in section 
I.B.5.e. of this final rule, to add references to ``PCCM entity'' as 
applicable;
     We proposed to revise the text in paragraph (c)(2)(i) 
concerning the start of the statutorily mandated 90-day period during 
which an enrollee may disenroll without cause;
     We proposed to explicitly provide that a state may accept, 
at its option, either oral or written requests for disenrollment; and
     We proposed in (d)(2)(iv) to specify an additional cause 
for disenrollment. We also proposed grammatical and clarifying 
corrections to the regulation text.
    In our proposal, paragraphs (a) through (c)(1) were unchanged from 
the current rule except for the addition of PCCM entity. In paragraph 
(c)(2)(i), we proposed to modify our approach to an enrollee's 90-day 
without cause disenrollment period. Section 1932(a)(4)(A) of the Act 
specifies that a state plan must permit disenrollment without cause 
from a managed care entity during the first 90 days of enrollment under 
mandatory managed care programs. As part of the 2002 final rule, we 
exercised authority under section 1902(a)(4) of the Act to extend this 
standard to state plans with voluntary managed care programs and to 
PIHPs and PAHPs (whether voluntary or mandatory). As finalized in 2002, 
we interpreted the clause ``90 days following the date of the 
beneficiary's initial enrollment'' to mean enrollment with a particular 
MCO, PIHP, PAHP, or PCCM and to allow an enrollee to disenroll from a 
MCO, PIHP, PAHP, or PCCM every 90 days until he or she had exhausted 
all contracted MCO, PIHP, PAHP, or PCCM options for which he or she is 
eligible. As noted in the preamble to the proposed rule, we believe 
that this provision has been applied in an inconsistent manner, and 
that such an approach is disruptive to the goals of establishing 
enrollee-provider relationships that support a coordinated delivery 
system and contribute to medical and administrative inefficiencies. 
Therefore, we proposed in paragraph (c)(2)(i) to revise the regulation 
to limit the 90-day without cause disenrollment period to the first 90 
days of an enrollee's initial enrollment into any MCO, PIHP, PAHP, or 
PCCM offered through the state plan; therefore, an enrollee would have 
only one 90-day without cause disenrollment opportunity per enrollment 
period. We explained that the revised approach is consistent with our 
interpretation of the intent of section 1932(a)(4)(A)(ii) of the Act, 
represents current practice in some states, and supports efficiency 
under the Medicaid program. We proposed no changes to paragraphs 
(c)(2)(ii) through (iv).
    We proposed to add the phrase ``as required by the state'' to Sec.  
438.56(d)(1) to clarify that this section of the regulation was 
intended to give states the flexibility to accept disenrollment 
requests either orally, or in written form, or both ways if the state 
so desires. We expressed our intent to interpret ``written request'' 
for purposes of this regulation to include online transactions or 
requests conducted with an electronic signature. A state could also 
accept requests orally, but require written confirmation of the oral 
request. Under our proposal, the state's standard for the form of 
disenrollment requests would have to be clearly communicated to 
enrollees to take advantage of this flexibility.
    In paragraph (d)(2)(iv), we proposed to add a new cause for 
disenrollment: the exit of a residential, institutional, or employment 
supports provider from an enrollee's MCO, PIHP, or PAHP network. We 
noted that provider network changes can have a significant impact on 
those enrolled in MLTSS programs, since such providers are typically 
integral to residential and work services and supports. Therefore, if 
the state does not permit participants enrolled in MLTSS to switch 
managed care plans (or disenroll to FFS), at any time, we proposed that 
states must permit enrollees to disenroll and switch to another managed 
care plan or FFS when the termination of a provider from their MLTSS 
network would result in a disruption in their residence or employment. 
We proposed to codify this additional cause for disenrollment as Sec.  
438.56(d)(2)(iv) and to redesignate the existing text at that paragraph 
to (d)(2)(v). In paragraph (d)(3), we proposed to add text to clarify 
that disenrollment requests that the MCO, PIHP, PAHP, PCCM, or PCCM 
entity does not approve would have to be referred to the state for 
review. This would not change the meaning but we believed it would 
improve the readability of the sentence. The existing text was 
otherwise retained in paragraph (d)(5), except to add PCCM entities to 
its scope as discussed elsewhere. We also proposed two minor 
grammatical corrections to paragraph (d) of this section. In current 
paragraph (d)(1)(ii), the term ``PIHP'' is in its singular form, but 
must be changed to plural to conform to other terms in the paragraph. 
We also proposed to use the possessive form for MCO, PIHP, and PAHP 
where applicable.
    In paragraph (e)(1), we proposed changes for clarification. 
Currently in paragraph (e)(1) of this section, the timeframe for a 
state to process a disenrollment request is intended to apply to 
enrollee requests for disenrollment. The timeframe applies regardless 
of whether the enrollee submits the request- directly to the state or 
to the MCO, PIHP, PAHP, PCCM, or PCCM entity (if permitted by its 
contract with the state.) However, Sec.  438.56(d)(1)(ii) permits 
states to allow MCOs, PIHPs, PAHPs, and PCCMS to process disenrollment 
requests. Additionally, in these instances, the managed care plan can 
approve the request, but it cannot actually disapprove the request. 
Instead, per Sec.  438.56(d)(3), it must forward the request to the 
state. In these instances, the timeframe for the state to process a 
disenrollment request referred by the plan is the same as if the 
enrollee had submitted it directly to the state. To clarify this 
intent, in paragraph (e)(1), we proposed to insert the term 
``requests'' after the term ``enrollee'' and replaced the term 
``files'' with ``refers.'' No changes were proposed in paragraphs (f) 
and (g).
    We received the following comments in response to our proposal to 
revise Sec.  438.56.
    Comment: Many commenters supported the proposed provision to limit 
disenrollment during the initial 90 days of managed care plan 
enrollment in Sec.  438.56(c)(2)(i). Commenters believed limiting this 
disenrollment option to one 90 day period during the initial enrollment 
period would promote continuity and facilitate plans' coordination 
efforts. We also received many supportive comments for the additional 
for cause disenrollment reason for enrollees using LTSS in Sec.  
438.56(d)(2)(iv). Commenters believed that it is appropriate to include 
this reason given the nature of the services that enrollees receive 
from these types of providers.
    Response: We thank the commenters for their support of our 
proposals in Sec.  438.56 to limit enrollees to only one

[[Page 27620]]

90 day disenrollment opportunity and the new for cause reason for 
enrollees using LTSS.
    Comment: A few commenters requested that CMS not use the word 
``disenrollment'' when referencing a change among managed care plans in 
proposed Sec.  438.56. Commenters believed ``disenrollment'' more 
appropriately described the process of losing eligibility for managed 
care or Medicaid completely, rather than merely changing from one 
managed care plan to another. One commenter suggesting that the right 
to change managed care plans at least every 12 months be called ``open 
enrollment.''
    Response: We understand the commenters' suggestions but decline to 
adopt a different word in Sec.  438.56. The term ``disenroll'' is 
consistent, and we believe clear, in relation to the uses of 
``enrollee'' and ``enroll'' as used throughout part 438. We understand 
the commenter's suggested use of ``open enrollment'' given the common 
use of that term in the Marketplace and private group market; however, 
we decline to adopt that term in part 438. States are free to adopt 
that terminology if they choose to but we do not believe it is 
appropriate to mandate its use.
    Comment: One commenter stated that Sec.  438.56(b) should be 
removed because managed care plans should not have the ability to 
request disenrollment of an enrollee under any circumstances. Another 
commenter believed that before a state approves a managed care plan's 
request for disenrollment of an enrollee, the managed care plan should 
have to demonstrate why it is unable to provide the needed services and 
how many times they performed outreach to the enrollee to resolve the 
issue.
    Response: We do not agree with the first commenter. This provision 
was included in the final rule in 2002 and it provides a reasonable 
mechanism for managed care plans to have available to them in unusual 
circumstances when it is unable to properly serve an enrollee. We agree 
with the second commenter to the extent that states should have an 
appropriate review process for disenrollment requests from a managed 
care plan. Section 438.56(b)(3) requires the contract to specify the 
method by which the managed care plan, PCCM, or PCCM entity assures the 
state that it does not request disenrollment for prohibited reasons, 
which are listed in paragraph (b)(2) (that is, change in enrollee's 
health status, an enrollee's utilization of services, or an enrollee's 
uncooperative behavior resulting from special needs). Such requests 
should be a rare occurrence that are duly scrutinized by the state to 
avoid disruptions in care. The commenter's suggestion that the managed 
care plan must demonstrate why it cannot provide needed services and 
document the failed attempts at a resolution of the issue may not be 
applicable in every circumstance where a managed care plan would 
request disenrollment of an enrollee. Therefore, we decline to require 
such justifications on the part of the managed care plans.
    Comment: Some commenters recommended that CMS include additional 
prohibited reasons for a managed care plan to request disenrollment. 
Those suggestions included enrollee's race, color, national origin, 
disability, age, sex, gender identity, sexual orientation, mental 
health condition, disability, need for language services, and need for 
long term care services. Commenters believed proposed Sec.  
438.56(b)(2) needed additional specificity to prevent inappropriate 
requests for disenrollment. One commenter also requested that CMS 
clarify that enrollment in long-term care is not disenrollment from 
acute care due to health status.
    Response: We understand the commenters' concerns but believe that 
all of the suggestions are already addressed in part 438. Race, color, 
national origin, disability, age, and sex, are addressed in proposed 
Sec.  438.3(f)(1), which applies to all provisions of every managed 
care contract; further, Sec.  438.206(c)(2) (discussed in section 
I.B.6.a), requires managed care plans to provide access to services in 
a culturally competent manner to all enrollees, regardless of limited 
English proficiency, sexual orientation, gender identity, and gender. 
It is not necessary to duplicate these restrictions on plan conduct in 
Sec.  438.56(b)(2). Behavioral health conditions and disability status 
are already clearly addressed in several of the prohibited reasons 
listed in proposed Sec.  438.56(b)(2), including adverse change in the 
enrollee's health status, or because of the enrollee's utilization of 
medical services, diminished mental capacity.'' We are unclear what 
clarification is being requested in the comment that ``enrollment in 
Long Term Care is not disenrollment from acute care due to health 
status'' since an ``adverse change in health condition'' is already 
list in proposed Sec.  438.56(b)(2) as a reason when a managed care 
plan cannot request disenrollment.
    Comment: We received suggestions for a new section that would list 
conditions when a state must disenroll an enrollee from their assigned 
managed care plan. These suggestions included the following: An 
enrollee's Medicaid eligibility is terminated; the state did not assign 
the enrollee to the managed care plan requested or assigned due to 
incorrect information provided by the state or due to prohibited 
marketing practices; request for disenrollment is due to plan merger; 
change of place of residence to outside the plan's service area; 
anytime an enrollee requests disenrollment outside of a restricted 
disenrollment period; for a reason in Sec.  438.56(d)(2); and when the 
enrollee is ineligible for managed care enrollment as defined in Sec.  
438.54.
    Response: We believe states currently disenroll enrollees when 
Medicaid eligibility is terminated and as specified in the provisions 
of proposed Sec.  438.56(d)(2). We believe that states have mechanisms 
to appropriately address cases when there is evidence of a compliance 
violation or processing error; such mechanisms should provide for 
disenrollment when warranted. The suggestion that all disenrollment 
requests made outside of a restricted disenrollment period is addressed 
in proposed Sec.  438.56(c)(2)(i) with the provision of a 90 
disenrollment period and in Sec.  438.56(c)(2)(ii) with the provision 
of an annual disenrollment opportunity. During those times, enrollees 
do not need a for cause reason to change plans. We do not believe 
additional ``no cause'' disenrollment opportunities should be mandated; 
however, states have the flexibility to provide additional 
opportunities if they desire. A change in residence outside the managed 
care plan's service area is already addressed in Sec.  438.56(d)(2)(i). 
We do not agree that plan merger should necessitate automatic 
disenrollment; we believe the provision of disenrollment rights as the 
result of a merger should be decided based on the specific 
circumstances of the merger. For example, if the merger does not reduce 
the provider network or benefits available to the enrollee, forced 
disenrollment may cause unnecessary disruption and confusion. We 
support flexibility to allow states to determine the most appropriate 
procedures for addressing mergers as well as their ability to offer 
enrollees the option of changing plans if they believe that is the best 
approach. We are not adopting additional regulation text in Sec.  
438.56(c) or (d) in response to these comments.
    Comment: We received one suggestion that disenrollment reasons 
should be made public and submitted to CMS so it can be determined if 
certain managed care plans are not meeting performance standards. 
Another commenter believed that states should make disenrollment 
reasons known to

[[Page 27621]]

the managed care plans for their use in improving their performance.
    Response: We understand the importance of analyzing disenrollment 
data for insight about managed care plan performance, real and 
perceived. We encourage states to share that information with their 
managed care plans as it can be a valuable source of opportunities for 
performance improvement. We believe that part 438 includes sufficient 
requirements for states and managed care plans for making information 
available to the public and for reporting to CMS. We do not believe 
revisions are needed to Sec.  438.56 in response to these comments.
    Comment: One commenter believed that proposed regulation at Sec.  
438.56 would bar the beneficiary from changing MCOs without showing 
good cause during the 90-day disenrollment period in proposed Sec.  
438.56(c)(2)(i).
    Response: We appreciate the opportunity to clarify that Sec.  
438.56(c)(2)(i) does not limit the enrollee's right to disenroll 
provided in section 1932(a)(4)(A) of the Act, which provides for 
disenrollment without cause from a managed care entity during the first 
90 days of enrollment under a mandatory managed care program. In the 
2002 final rule and again in this final rule, we extend this 
disenrollment right to all types of managed care plans, not only MCOs 
and PCCMs.
    Comment: We received one comment requesting clarification if a 
state can offer a ``no cause'' period longer than 90 days.
    Response: We appreciate the opportunity to clarify that states do 
have flexibility to extend the period beyond 90 days, but they cannot 
provide less than 90 days.
    Comment: We received many comments on our clarification of 
``initial enrollment'' in proposed Sec.  438.56(c)(2)(i). Many 
commenters were supportive of limiting enrollees to only one 90 day 
period; these commenters believed this supported better care 
coordination and transition planning. Conversely, many other commenters 
were opposed to the limitation and believed that enrollees may need 
more than the first 90 days to determine if there are access or network 
issues that necessitate a plan change.
    Response: We appreciate all of the comments on this provision. 
After consideration of the revision to Sec.  438.54 to remove the 
proposed 14 day choice period, we believe it is prudent not to finalize 
the proposed revision in Sec.  438.56(c)(2)(i) limiting enrollees to 
only one 90-day without cause disenrollment opportunity for each 
initial managed care plan enrollment. While we agree with some 
commenters that multiple no cause disenrollment opportunities can be 
disruptive to transition and coordination efforts, we believe not 
finalizing the limitation of one 90-day period is appropriate given the 
removal of the mandatory FFS choice period for managed care plan 
selection. We want to clarify that the 90-day disenrollment opportunity 
is driven by an enrollee's initial enrollment into each managed care 
plan, not by the enrollment period itself. Additionally, for 
readability and clarity, we are adding text to clarify that the 90-day 
disenrollment period begins after an initial enrollment into a specific 
managed care plan or the date the State sends the notice about 
enrollment into that specific plan. Section 438.56(c)(2)(i) will be 
finalized to state that during the 90 days following the date of the 
beneficiary's initial enrollment into the specific MCO, PIHP, PAHP, 
PCCM, or PCCM entity, or during the 90 days following the date the 
State sends the beneficiary notice of that enrollment, whichever is 
later.
    Comment: We received several comments asking that CMS require 
alignment between an enrollee's eligibility redetermination and their 
annual right to change managed care plans. We also received a few 
comments asking that CMS clarify that ``. . . 12 months thereafter.'' 
in proposed Sec.  438.56(c)(2)(ii) begins on the first day of 
enrollment in the managed care plan, rather than from the end of the 90 
day period.
    Response: Aligning an enrollee's eligibility redetermination and 
their right to change managed care plans is a common method that states 
utilize; however, given the variation in states' programs and how they 
implement the change of managed care plan process (under to Sec.  
438.56(c)(2)(ii) and their redetermination process, it may not always 
be feasible. As such, we decline to revise Sec.  438.56 and will 
continue to leave the timing of these processes to a state's 
discretion. This regulation does not impose a requirement that the two 
events occur at the same time.
    We appreciate the opportunity to clarify ``12 months thereafter.'' 
A state can use either the first day of enrollment in the managed care 
plan or the end of the 90 day period to begin the 12 month period so 
long as the enrollee is provided at least one opportunity to change 
their managed care plan without cause within 12 months from the 
selected date. We understand the commenters' issue that the result of 
using the end of the 90-day period is that the enrollee is in the 
managed care plan for a minimum of 15 months. However, during that 
time, the enrollee will have had at least 2 opportunities to disenroll 
without cause: the first opportunity being the initial 90 days and the 
second being within the 12 months beginning on the 91st day.
    Comment: We received one comment requesting that CMS confirm that 
states can offer disenrollment more than once every 12 months.
    Response: We appreciate the opportunity to clarify that Sec.  
438.56(c)(2)(ii) requires a without cause disenrollment opportunity at 
least once every 12 months. This provides flexibility for states to 
offer more than one disenrollment opportunity during a 12 month period.
    Comment: One commenter recommended that proposed Sec.  438.56(d)(1) 
require that oral disenrollment requests be followed up in writing. 
Another commenter recommended that states be required to allow oral 
requests.
    Response: We believe specifying the method for enrollees to request 
disenrollment is best left to the states' discretion, given the wide 
variation in program design and the frequency of disenrollment 
opportunities permitted.
    Comment: One commenter requested that CMS require enrollees to 
exhaust their grievance and appeal rights prior to the state approving 
their disenrollment request. The commenter believed that would provide 
the managed care plan the opportunity to resolve the issue and prevent 
the disruption associated with disenrollment.
    Response: We believe states are in the best position to determine 
the best process for disenrollment based on their program design and 
covered populations. We acknowledge that the grievance system processes 
may eliminate an enrollee's desire to disenroll by resolving the issue 
that led to the disenrollment request, which we agree is beneficial for 
continuity and quality of care. However, we believe that states should 
have the flexibility to decide whether the grievance process is 
beneficial for enrollees requesting disenrollment. In terms of the 
commenter's suggestion that enrollee's be required to exhaust the 
appeals process before a for cause disenrollment would be processed, we 
decline to modify the text since the situations addressed in the for-
cause reasons for disenrollment in Sec.  438.56(d)(2) may not be 
remedied through the appeals process as those situations would not 
constitute an adverse benefit determination, as defined in Sec.  
438.400.
    Comment: Some commenters requested that CMS develop an

[[Page 27622]]

expedited disenrollment process. These commenters' suggestions included 
expedited disenrollment for American Indian or Alaska Native enrollees, 
enrollees that are in foster care or adoption assistance, enrollees 
that have a complex condition, enrollees in a section 1915(c) or 
1915(i) waiver program, or enrollees that have experienced a breakdown 
in the patient-physician relationship.
    Response: We do not agree that a separate process is needed to 
address these situations. States have the ability to effectuate 
disenrollment requests as quickly as they deem necessary; Sec.  
438.56(e)(i), as proposed and as finalized, states that regardless of 
the procedures followed, the effective date of an approved 
disenrollment must be no later than the first day of the second month 
following the month in which the enrollee requests disenrollment or the 
MCO, PIHP, PAHP, PCCM or PCCM entity refers the request to the State. 
This allows states complete flexibility to effectuate disenrollments in 
shorter timeframes based on the enrollee's circumstances. Additionally, 
other enrollee protections exist in part 438 to ensure that enrollees 
receive the services they need. For example, Sec.  438.206(b)(4) allows 
coverage of out of network providers if the necessary services are not 
available within the network. We decline to revise Sec.  438.56 to 
include an expedited process.
    Comment: Many commenters suggested additional for cause 
disenrollment reasons in proposed Sec.  438.56(d)(2). Suggestions 
included if an enrollee's primary care provider, regularly utilized 
provider, home health, home care aid, medical home, integrated health 
system, or ACO, nursing home, or in home helper leaves the network; a 
family member is in a different managed care plan; a PACE organization 
becomes available; and poor quality case management.
    Response: We appreciate the wide variety of suggestions on this 
provision. However, we believe Sec.  438.56(d)(2)(i) through (v) is 
sufficient as a minimum list of for cause disenrollment reasons. States 
are free to offer, and we encourage states to consider, additional for 
cause reasons as they deem appropriate for their programs and 
enrollees.
    Comment: One commenter recommended that states be required to 
perform adequate network monitoring in an attempt to reduce 
disenrollments. One commenter believed that managed care plans should 
do more transition planning and not just disenroll enrollees.
    Response: We agree that state monitoring of network adequacy may 
help reduce some disenrollment requests and believe that appropriate 
monitoring mechanisms are included in Sec.  438.66 and Sec.  438.207, 
discussed elsewhere in this final rule. We also agree that robust 
transition planning can also help reduce disenrollment requests. We 
encourage states and managed care plans to consider this when 
developing their transitions plans as required in proposed in Sec.  
438.62(b).
    Comment: We received one comment requesting that CMS define 
``employment, residential, and institutional supports provider'' as 
used in Sec.  438.56(d)(2)(iv).
    Response: Employment, residential, and institutional supports is a 
broad category of services defined by each state in the design of its 
program. Further, we review the services proposed as part of a state's 
statutory authority request that authorizes such services. Appropriate 
detail on the scope of covered services should be included in each 
managed care plan contract. Given the variation that may exist among 
states' use of these terms, we decline to add definitions to the final 
regulation.
    Comment: We received many comments on the proposed disenrollment 
reason for enrollees receiving LTSS in Sec.  438.56(d)(2)(iv). Many of 
them were supportive but some commenters had concerns. A few commenters 
believed that managed care plans should be allowed the opportunity to 
negotiate single case agreements with the departing provider prior to 
approval of the disenrollment request. Other commenters were concerned 
that the automatic approval of these requests may be detrimental to the 
enrollee if the provider is being terminated for quality of care 
issues. One commenter suggested that CMS adopt two criteria for states 
approving these disenrollment requests: The MCO, PIHP, or PAHP cannot 
reach a mutually agreeable agreement with the provider to maintain 
continuity of coverage on an out-of-network basis; and a change in 
residential, institutional or employment supports provider would 
constitute a significant hardship to the enrollee. One commenter 
requested clarification on if the disenrollment process allows 
enrollees to return to FFS or only to change managed care plans.
    Response: We thank the commenters for their supportive comments. We 
also appreciate the comments that raise the concern of disruption to 
the enrollee's ability to retain their residence, employment, or 
institutional provider. In the preamble at 80 FR 31136, we provided: 
``Therefore, if the state does not permit participants enrolled in 
MLTSS to switch managed care plans (or disenroll to FFS), at any time, 
states must permit enrollees to disenroll and switch to another managed 
care plan or FFS when the termination of a provider from their MLTSS 
network would result in a disruption in their residence or 
employment.'' However, proposed Sec.  438.56(d)(2)(iv) did not 
accurately reflect that a disruption in the enrollee's place of 
residence or employment was critical to approving the for-cause 
disenrollment in this context. To correct this omission, we will 
finalize Sec.  438.56(d)(2)(iv) with text to reflect that the enrollee 
must experience a disruption in their residence or employment to 
utilize this disenrollment reason. As stated in the 2013 MLTSS 
guidance, there must be a heightened level of intervention by the state 
in instances where a participant's residence and services are linked, 
and therefore where the loss of the provider also means that the 
participant might lose employment and/or have to move out of his or her 
current residence to maintain services.
    We believe that permitting the managed care plan to attempt to 
negotiate with a provider to either not terminate their contract or to 
continue seeing certain enrollees on an out-of-network/limited 
participation basis should be part of the managed care plan's provider 
termination process, rather than the enrollee's disenrollment process. 
If a state elects to accommodate the managed care plan's attempt to 
permit the provider to continue seeing individual enrollees on an out-
of-network basis in their disenrollment process, we remind states and 
managed care plans of the timeframe for disenrollment determinations in 
Sec.  438.56(e) and expect states and managed care plans to adhere to 
them in a manner that does not disadvantage the enrollee. Any efforts 
by the managed care plan to use a single case agreement with a provider 
to maintain an enrollee's ability to access the provider must be 
concluded within the timeframes for disenrollment determinations in 
Sec.  438.56(e). Otherwise, the disenrollment request must be 
processed.
    Comment: We received a few comments recommending that a new 
requirement be added in proposed Sec.  438.56(e) to require states to 
send notices to enrollees confirming their disenrollment within 5 days 
of processing the request. We also received a comment on proposed Sec.  
438.56(e)(1) requesting that ``. . . or the MCO, PIHP, PAHP, PCCM or 
PCCM entity refers the

[[Page 27623]]

request to the State'' be deleted. The commenter believed the timeframe 
for approving a disenrollment request should always be from the date 
the enrollee requests it. We received one comment stating that the 
effective date deadline in paragraph (e)(1) (``. . . be no later than 
the first day of the second month following the month in which the 
enrollee requests disenrollment or the MCO, PIHP, PAHP, PCCM or PCCM 
entity refers the request to the State'') was too long and recommending 
that the effective date for the disenrollment be sooner.
    Response: Given the variation in disenrollment processes among 
states, we decline to require a confirmation notice in Sec.  438.56(e). 
When enrolled in a new managed care plan, the enrollee receives an 
identification card and other information from the new managed care 
plan, which clearly conveys to the enrollee that their disenrollment 
from the previous managed care plan has occurred. Receiving a notice of 
disenrollment could be confusing for the enrollee; therefore, we 
decline to mandate it. However, states are free to send notices if they 
believe it would be a benefit to their enrollees, particularly given 
the increased flexibility provided in this rule for the use of 
electronic communications. We also decline to delete ``. . . or the 
MCO, PIHP, PAHP, PCCM or PCCM entity refers the request to the State'' 
because many states do not permit their managed care plans to be 
involved in the disenrollment process. We are confident that the states 
that do permit managed care plan participation, have processes, 
including time frames, that provide the state with adequate processing 
time to meet the requirement in Sec.  438.56(e)(1). We take this 
opportunity to clarify that Sec.  438.56(e)(1) sets the outside limit 
for the effective date of the disenrollment, which permits states to 
effectuate the disenrollment at any time prior to the first day of the 
second month.
    Comment: One commenter recommended that disenrollment information 
be provided at the time of the application for Medicaid eligibility and 
enrollment.
    Response: Section 438.54 (c)(3) and (d)(3), as proposed and 
finalized, require the provision of disenrollment information at the 
time of enrollment. Additionally, Sec.  438.10(e)(2)(i) includes the 
requirement that notice to potential enrollees must include the 
disenrollment information described in Sec.  438.56. It is outside the 
scope of this rule to make requirements for the information provided at 
the time of application for Medicaid eligibility in general.
    Comment: We received one comment suggesting that CMS add a 
requirement that the notice required in Sec.  438.56(f) must include 
information on enrollee's disenrollment rights provided in Sec.  
438.56(c)(2).
    Response: We agree that Sec.  438.56(f) could be clearer. 
Therefore, we have finalized Sec.  438.56(f) to require that the notice 
include an explanation of all of the enrollee's disenrollment rights as 
specified in this section.
    Comment: We received one comment requesting that proposed Sec.  
438.56 (g) permit automatic reenrollment after longer than 2 months of 
ineligibility.
    Response: Section 1903(m)(2)(H) of the Act specifies a re-
enrollment window of 2 months and implicitly authorizes a shorter time 
period but not a longer one.
    After consideration of the public comments, we are adopting Sec.  
438.56 as proposed with four substantive revisions. First, in 
paragraph(c)(2)(i), we are revising ``. . . enrollment into a . . .'' 
to ``. . . enrollment into the . . .'' to clarify that more than one 90 
day disenrollment period is permitted and adding ``during the 90 days 
following'' before ``the date the State sends . . . .'' for added 
clarity. Second, in paragraph (d)(2)(iv), we are finalizing with text 
that was described in the preamble but erroneously omitted from the 
proposed regulation text that addressed MLTSS enrollees experiencing a 
disruption to residence or employment. Third, in paragraph (f)(1), we 
are finalizing an additional requirement to include information on all 
disenrollment opportunities in the required notice. Fourth, although 
not proposed, we are also removing ``health'' in paragraph (d)(2)(v) in 
the final rule to consistently reflect a less acute care approach and 
be more inclusive of enrollees receiving LTSS. This change is 
consistent with proposals (and final regulation text) throughout the 
rule to acknowledge the managed care programs increasingly include LTSS 
and that requirements for managed care plans generally apply to LTSS as 
well as health care services provided by the plan. Finally, we are 
making technical corrections throughout Sec.  438.56 to add commas as 
applicable when referencing groups of managed care plan types.
c. Beneficiary Support System (Sec. Sec.  438.2, 438.71, 438.810, 
438.816)
    Although the existing regulation at Sec.  438.10 acknowledges the 
importance of information and disclosure in helping the beneficiary 
choose a managed care plan, we recognized in the proposed rule that 
some beneficiaries may need additional assistance when evaluating their 
choices. This additional assistance includes having access to 
personalized assistance--whether by phone, internet, or in person--to 
help beneficiaries understand the materials provided, answer questions 
about options available, and facilitate enrollment with a particular 
managed care plan or provider.
    We proposed a new Sec.  438.71, entitled Beneficiary Support 
System, to require this additional assistance to potential enrollees 
and enrollees.
    Proposed paragraph (a) established the requirement that a state 
develop and implement a beneficiary support system to provide support 
before and after managed care enrollment. Paragraph (b) proposed four 
minimum functions for a beneficiary support system: Paragraph (b)(1)(i) 
would make choice counseling available to all beneficiaries; paragraph 
(b)(1)(ii) would require training of plans and network providers on the 
type and availability of community based resources and supports; 
paragraph (b)(1)(iii) would require assistance to all beneficiaries in 
understanding managed care; and paragraph (b)(1)(iv) would add 
assistance for enrollees who receive or desire to receive LTSS. In 
paragraph (b)(2), we proposed that the system be available to the 
beneficiaries in multiple ways including phone, internet, in-person, 
and via auxiliary aids and services when requested.
    We proposed at Sec.  438.71(c)(1) that states provide choice 
counseling services for any potential enrollee (that is, prior to first 
enrollment in managed care) or to managed care enrollees when they have 
the opportunity or requirement to change enrollment under Sec.  
438.56(b) and (c). States have the flexibility to decide who can 
provide choice counseling; however, in paragraph (c)(2), we proposed 
that any individual or entity providing choice counseling services 
would be an enrollment broker under our regulations, and therefore, 
must meet the independence and conflict of interest standards of Sec.  
438.810 to provide those services. We noted that some entities may 
receive federal grant funding distinct from Medicaid funding that may 
require those entities, such as FQHCs or Ryan White providers, to 
conduct activities similar to those that would fall under the 
definition of choice counseling; if those entities do not have a 
memorandum of agreement or contract with the state to provide choice 
counseling on the state's behalf, such entities would not be required 
to adhere to the conflict of interest standards in Sec.  438.810 under 
our proposal at Sec.  438.71(c)(2). While not discussed, we note here 
that such

[[Page 27624]]

separate obligation to provide services similar to choice counseling 
services would not satisfy the state's obligation under Sec.  
438.71(a). We noted that this was not an exhaustive list of federal 
grantees and was provided for illustrative purposes. We also requested 
comment on whether entities that provide non-Medicaid federally-
financed protections to beneficiaries that includes representation at 
hearings should be allowed to also contract with the state to provide 
choice counseling as long as appropriate firewalls are in place; we 
proposed in paragraph (e)(3)(i) a firewall requirement for such 
entities to represent enrollees receiving LTSS from the managed care 
entity.
    Under proposed paragraph (d), the beneficiary support system would 
provide training to MCO, PIHP, and PAHP staff and network providers on 
community based resources and supports that can be linked with covered 
benefits. As noted in the following responses to public comments, we 
are not finalizing proposed paragraph (d); therefore, the paragraphs 
following proposed paragraph (d) have been redesignated accordingly.
    In proposed paragraph (e) (finalized as paragraph (d)), we proposed 
four elements for a beneficiary support system specific to 
beneficiaries who use, or desire to use, LTSS: (1) An access point for 
complaints and concerns about enrollment, access to covered services, 
and other related matters; (2) education on enrollees' grievance and 
appeal rights, the state fair hearing process, enrollee rights and 
responsibilities, and additional resources; (3) assistance (without 
representation), upon request, in navigating the grievance and appeal 
process and appealing adverse benefit determinations made by a plan to 
a state fair hearing; and (4) review and oversight of LTSS program data 
to assist the state Medicaid Agency on identification and resolution of 
systemic issues. Proposed paragraph (e)(1) (finalized as (d)(1)) 
applies to enrollees of MCOs, PIHPs, PAHPs, PCCMS, and PCCM entities 
while (e)(2) through (e)(4) (finalized as (d)(2) through (d)(4)) apply 
only to MCOs, PIHPs, and PAHPs since they reference the grievance and 
appeal process which PCCMs are not required to have.
    We acknowledged that states may include many of these services 
already within their Medicaid program and indicated our intent that our 
proposed regulation does not require that states develop a new system 
of delivering all the functions proposed in Sec.  438.71(e) (finalized 
as Sec.  438.71(d)) for MLTSS. Under our proposal, states would be 
permitted to draw upon and expand, if necessary, those existing 
resources to meet the standards proposed in this section.
    We noted in the preamble of the proposed rule that the proposed 
scope of services for LTSS beneficiary supports may include what has 
been traditionally considered ``ombudsman'' services; however, rules 
concerning Medicaid-reimbursable expenditures remain in place, so we 
cautioned that not all ombudsman activities traditionally found in a 
Long-Term Care Ombudsman office may be eligible for Medicaid payment 
under this proposal. We issued an informational bulletin on June 18, 
2013, entitled ``Medicaid Administrative Funding Available for Long-
Term Care Ombudsman Expenditures,'' that provided guidance on this 
issue. The informational bulletin is available at http://www.medicaid.gov/Federal-Policy-Guidance/downloads/CIB-06-18-2013.pdf.
    We also proposed to move the definition of choice counseling to 
Sec.  438.2, which was previously defined in Sec.  438.810, and to 
revise the definition to the provision of information and services 
designed to assist beneficiaries in making enrollment decisions, 
including answering questions and identifying factors to consider when 
choosing among managed care plans and primary care providers. We 
proposed to clarify in the revised definition that choice counseling 
does not include making recommendations for or against enrollment into 
a specific MCO, PIHP, or PAHP. Further, we proposed in Sec.  438.810 to 
include PCCM entities in the regulatory text when other managed care 
plans were mentioned, and we proposed to add electronic methods of 
communication as a means through which enrollment activities could be 
conducted in the definition of ``enrollment activities'' in Sec.  
438.810(a).
    Finally, we proposed a new section Sec.  438.816 that would impose 
conditions that must be met for the state to claim FFP for the LTSS-
specific beneficiary support system activities proposed in Sec.  
438.71(e) (and finalized as paragraph (d)). We modeled this standard, 
in part, on current rules for claiming FFP for administrative services 
and, in part, on the current rules for enrollment broker services. We 
proposed, consistent with our current policy, that beneficiary support 
services for MLTSS enrollees be eligible for administrative match 
subject to certain standards. Specifically, in paragraph (a), we 
proposed that costs must be supported by an allocation methodology that 
appears in the state's Public Assistance Cost Allocation Plan; in 
paragraph (b) that the costs do not duplicate payment for activities 
that are already being offered or should be provided by other entities 
or paid by other programs; in paragraph (c) that the person or entity 
providing the service must meet independence and conflict of interest 
provisions applicable to enrollment brokers in Sec.  438.810(b); and in 
paragraph (d) that the initial contract or agreement for services in 
this section be reviewed and approved by CMS.
    We received the following comments in response to our proposals at 
Sec. Sec.  438.2, 438.71, 438.810, and 438.816.
    Comment: Many commenters supported the provisions at Sec.  438.71 
and provided several examples for how a beneficiary support system 
would play an integral role in a state's Medicaid managed care program, 
including supports for complex populations and individuals receiving 
LTSS.
    Response: We thank commenters for their support and agree that a 
beneficiary support system will play an integral role in a state's 
Medicaid managed care program, including supports for complex 
populations and individuals receiving LTSS. We maintain that the 
resources provided by the beneficiary support system will benefit all 
covered populations in navigating the managed care delivery system.
    Comment: Several commenters had concerns regarding the provisions 
at Sec.  438.71 generally. For example, a few commenters believed that 
states with mature managed care programs did not need to provide this 
type of support for potential enrollees and enrollees. Other commenters 
specified that states have developed their own systems and that Sec.  
438.71 would undermine current state systems or add unnecessary and 
administratively burdensome requirements. One commenter stated that 
some beneficiaries may not be interested in the resources and 
information provided by the beneficiary support system. One commenter 
recommended that CMS only outline key principles of beneficiary 
engagement and not require the development of a beneficiary support 
system.
    Response: We maintain that states must make available an 
independent resource to aid potential enrollees in selecting a managed 
care plan and to assist enrollees in navigating the managed care 
delivery system. We understand that some states may have established 
arrangements to provide some or all of the resources specified in the 
beneficiary support system and remind commenters that states need not 
develop a new system if the current

[[Page 27625]]

system meets the standards specified at Sec.  438.71. The elements of 
the beneficiary support system specified in Sec.  438.71 are the 
benchmark for the provision of independent information and supports for 
Medicaid enrollees that must be applied across all Medicaid managed 
care programs. States are permitted to draw upon and expand their 
current beneficiary support systems as necessary and applicable in 
order to meet this new standard. We also recognize that not all 
potential enrollees or enrollees will need or want to engage with the 
beneficiary support system, but this is not a compelling reason to 
eliminate the system altogether or fail to make those services 
available to enrollees and potential enrollees who do want them.
    Comment: Several commenters had concerns with Sec.  438.71(a) 
regarding the availability of resources for states to operate 
beneficiary support systems. One commenter recommended that CMS clarify 
if beneficiary support and enrollment broker services are eligible for 
the enhanced match of 75 percent under section 1903(a)(2) of the Act. 
Several commenters stated that the beneficiary support system would 
create a significant administrative and financial burden for states. 
One commenter was concerned that beneficiaries might be charged for the 
system, and another commenter suggested that managed care plans might 
be assessed fees for states to develop and operate these systems. Other 
commenters recommended that certain requirements be scaled back to make 
the system more affordable and less onerous on states. One commenter 
stated that the beneficiary support system should make greater use of 
existing resources, such as State Health Insurance Assistance Programs 
(SHIPs) to reduce costs. Other commenters had concerns about CMS' 
capacity to oversee and ensure that beneficiary support systems are 
adequately funded and meet the standards specified in the regulation.
    Response: We understand commenters' concerns regarding the 
potential financial burden of maintaining the beneficiary support 
system and remind commenters that Medicaid administrative funding, as 
outlined at Sec.  438.810 and Sec.  438.816, is available to states. We 
clarify that beneficiary support and enrollment broker services are not 
eligible for the enhanced match of 75 percent under section 1903(a)(2) 
of the Act but are eligible at the administrative match rate. The 
commenter's concern regarding beneficiary financial liability for 
accessing the beneficiary support system is unfounded and prohibited as 
beneficiary financial liability is limited to services covered under 
the state plan or to premiums as permitted under 42 CFR part 447. We 
agree with commenters and encourage states to use existing resources 
and systems as feasible, including various community organizations and 
resources that otherwise meet the standards in this final rule. With 
respect to CMS capacity and oversight, we will provide appropriate 
oversight consistent with other aspects of the Medicaid managed care 
program.
    Comment: Several commenters recommended that CMS strengthen overall 
state monitoring, evaluation, and oversight of the beneficiary support 
system. A few commenters recommended that CMS revise the requirement at 
proposed Sec.  438.71(e)(4) (finalized as paragraph (d)(4)) for the 
beneficiary support system's review and oversight of LTSS program data 
to all program data, including specific grievance, complaint, and 
appeal data. Other commenters recommended that CMS require states to 
analyze and publicly report on the performance of their beneficiary 
support systems. A few commenters recommended that CMS require 
beneficiary survey data and feedback as part of the beneficiary support 
system's functions. Commenters also recommended that CMS require the 
LTSS advisory committee to be involved in the review of program data 
and all aspects of the beneficiary support system. One commenter 
recommended that CMS provide technical assistance in the identification 
and review of systemic issues identified through the beneficiary 
support system. Finally, one commenter recommended that CMS develop 
accountability measures to ensure that each state develops and 
maintains a competent and effective beneficiary support system.
    Response: We appreciate commenters' thorough recommendations. Many 
of the commenters' recommendations related to state monitoring and 
oversight are addressed in Sec.  438.66. We agree with commenters that 
the activities of the beneficiary support system should be included in 
state monitoring and believe that the reference at Sec.  438.66(b)(4) 
to customer services is sufficient to include the beneficiary support 
system maintained under Sec.  438.71; to make this clearer, we are 
finalizing additional regulatory text to explicitly include the 
beneficiary support system in that category (see section I.B.6.c.). We 
also agree with commenters that states should include information on 
and an assessment of the state's beneficiary support system in the 
managed care program assessment report required at Sec.  438.66(e). We 
believe it is important to not only report on the activities of the 
beneficiary support system, but to also assess the performance of the 
beneficiary support system to drive continual improvements. Therefore, 
as discussed in section I.B.6.c. we are finalizing regulatory text to 
include the beneficiary support system as a required element of this 
report at Sec.  438.66(e)(2)(ix) to ensure that it is addressed. Many 
of the commenters' other recommendations, including data on grievances 
and appeals and beneficiary survey data and feedback, are also included 
at Sec.  438.66. We have also required that states provide the managed 
care program assessment report to the LTSS stakeholder group at Sec.  
438.66(e)(3)(iii), and we require that states post the report publicly 
on their Web site at Sec.  438.66(e)(3)(i). Finally, we agree with 
commenters that we should provide technical assistance in the 
identification and review of systemic issues identified through the 
beneficiary support system and believe that this will be done as a 
regular part of our review and oversight of the program. Therefore, we 
do not believe it is necessary to include any additional regulatory 
requirements at Sec.  438.71 regarding state monitoring, evaluation, or 
oversight of the beneficiary support system, or about CMS technical 
assistance.
    Comment: Several commenters recommended that CMS require that 
managed care plans have input into the design and implementation of the 
state beneficiary support system.
    Response: Managed care plans may be effective partners for states 
when designing and implementing the beneficiary support system. 
However, due to the functions of the beneficiary support system, it 
must remain independent from the managed care plans. We encourage 
states to consider the best methods for engaging and incorporating 
feedback from managed care plans and a variety of other stakeholders as 
states develop and implement their beneficiary support systems.
    Comment: Several commenters recommended that CMS add caregivers to 
Sec.  438.71(b)(2) since, for enrollees with complex health needs, it 
is often the caregiver that is selecting the managed care plan for 
enrollment. One commenter stated that the 2013 MLTSS guidance included 
references to caregivers in the context of choice counseling and 
recommended the same language be incorporated into the regulatory text.

[[Page 27626]]

    Response: Section Sec.  438.71(b)(2) provides that the beneficiary 
support system ``must perform outreach to beneficiaries and/or 
authorized representatives.'' The term ``authorized representatives'' 
has more limited applicability than ``caregiver,'' which could include 
individuals who are not in a decision making role on behalf of the 
beneficiary. While we do not intend to minimize the significant role of 
caregivers in supporting individuals with special health care needs, 
expanding the scope of Sec.  438.71 beyond authorized representatives 
could result in unintended consequences for the beneficiary. Therefore, 
we decline to adopt commenters' recommendations to revise the 
regulatory text, but we encourage states to consider the critical 
importance of caregivers in supporting enrollees as they develop 
education, outreach, and support strategies.
    Comment: Several commenters recommended that CMS clarify the 
outreach requirement at Sec.  438.71(b)(2), which requires that the 
beneficiary support system must perform outreach to beneficiaries and/
or authorized representatives and be accessible in multiple ways 
including phone, Internet, in-person, and via auxiliary aids and 
services when requested. Commenters supported the provision but 
recommended that CMS provide additional specificity regarding the scope 
of the outreach requirement. Other commenters recommended that CMS add 
stronger language about cultural and linguistic competence and outreach 
for those with limited English proficiency and/or cognitive 
disabilities. Finally, one commenter recommended additional protections 
regarding beneficiary privacy when outreach is conducted using the 
telephone or Internet.
    Response: We understand commenters' concerns regarding the general 
outreach requirement at Sec.  438.71(b)(2) but decline to add 
specificity in the regulatory text, as we do not believe it is 
necessary to prescribe such requirements for states or their 
beneficiary support systems. We expect that beneficiary support systems 
will utilize a variety of tools and mechanisms to reach enrollees and 
believe that such methods will vary. We expect that states will work 
with beneficiary support systems to provide outreach as part of the 
process in assisting beneficiaries with managed care plan selection and 
as a way to educate enrollees on the managed care delivery system more 
generally. We also expect states to use beneficiary support systems as 
a tool to ensure that enrollees fully understand their enrollment and 
disenrollment options, especially during the enrollment and 
disenrollment timeframes specified in Sec. Sec.  438.54 and 438.56. We 
agree with commenters that states should consider cultural and 
linguistic competence and outreach for those with limited English 
proficiency and/or cognitive disabilities as appropriate. The 
regulatory text includes auxiliary aids and services when requested. We 
decline to include additional specific requirements in the regulatory 
text but encourage states to consider these elements when designing and 
implementing their beneficiary support systems. Finally, states are 
required to comply with Sec.  438.224 regarding confidentiality and to 
safeguard protected beneficiary information in the conduct of any 
outreach activities.
    Comment: Several commenters supported the choice counseling 
provision at Sec.  438.71(c) but recommended that CMS provide greater 
specificity in the final regulation, while several other commenters 
recommended that CMS provide greater flexibility. Several commenters 
recommended that CMS explicitly require choice counselors to disclose 
all options to the beneficiary, including services not funded through 
Medicaid and services for those dually eligible for Medicare and 
Medicaid. Several commenters recommended that CMS include the following 
four principles for choice counseling in the regulation: Comprehensive, 
Competent, Conflict-Free, and Continuous/Timely. One commenter stated 
that the information provided by the beneficiary support system should 
encompass medical, LTSS, and a wide range of other services, such that 
it would constitute a ``one stop shop'' for Medicaid enrollees.
    Response: As defined in Sec.  438.2, choice counseling is related 
to managed care plan enrollment; therefore, we decline to accept 
commenters' recommendations in this area. States can choose to expand 
the scope and types of resources available under the beneficiary 
support system as appropriate.
    Comment: A few commenters recommended that CMS require choice 
counseling at Sec.  438.71(c) to include managed care plan performance 
data to assist the beneficiary in making an enrollment choice.
    Response: We agree with commenters that transparency of quality 
data is important for both potential enrollees and current enrollees of 
managed care plans. At Sec.  438.334, states are required to develop 
and publish a Medicaid managed care quality rating system (MMC QRS) for 
managed care plans in the state. Additionally, at current Sec.  
438.364(b)(2), states are required to make available the EQR technical 
reports upon request. In particular, the quality ratings in particular 
will be a helpful tool for potential enrollees and enrollees. We 
encourage states to include such information in the materials provided 
to choice counselors, but we decline to add this specific requirement 
to the duties of the beneficiary support system when such quality data 
will be readily available on the state's Web site.
    Comment: One commenter recommended that the beneficiary support 
system perform the same roles as an ombudsman program. One commenter 
recommended that CMS clarify the oversight role of the beneficiary 
support system to ensure that there is no duplication of effort with 
other oversight functions. Other commenters stated concerns regarding 
oversight and the potential for conflict of interest when a legal 
entity is providing guidance to beneficiaries related to grievances, 
complaints, and hearings, and is also responsible for reviewing the 
program data referenced in proposed Sec.  438.71(e)(4) (finalized as 
paragraph (d)(4)).
    Response: We intentionally chose to differentiate the beneficiary 
support system at Sec.  438.71 from long-term care ombudsman programs. 
Consistent with the preamble of the proposed rule at 80 FR 31137, we 
also note that not all traditional ombudsman activities may be eligible 
for Medicaid funding. Further, states are responsible for oversight of 
their respective Medicaid programs and use a variety of entities and 
tools to assist in that effort. The beneficiary support system will be 
one of a number of such tools but ultimately the state has oversight 
responsibility. The review of program data that is included at proposed 
Sec.  438.71(e)(4) (finalized as paragraph (d)(4)) is designed to 
provide states with information to be used for oversight and monitoring 
of their MLTSS programs; however, we clarify that the beneficiary 
support system will not be providing direct oversight of any such MLTSS 
program.
    Comment: One commenter recommended that CMS expand the 
responsibility of the beneficiary support system to include 
facilitating Medicaid enrollment. One commenter recommended that CMS 
require an established relationship between the beneficiary support 
system and the care coordination programs within each managed care 
plan, particularly during beneficiary transitions between managed care 
plans.

[[Page 27627]]

    Response: We clarify for the commenter that the beneficiary support 
system includes facilitating enrollment for managed care plans, which 
is consistent with our definition of choice counseling under Sec.  
438.2 and our general approach throughout Sec.  438.71. We note the 
definition of choice counseling under Sec.  438.2 is defined as the 
provision of information and services designed to assist beneficiaries 
in making enrollment decisions; it includes answering questions and 
identifying factors to consider when choosing among managed care plans 
and primary care providers. Choice counseling does not include making 
recommendations for or against enrollment into a specific MCO, PIHP, or 
PAHP. The beneficiary support system is intended to provide 
personalized assistance and assist beneficiaries in making enrollment 
decisions with regard to managed care plans. This additional assistance 
includes facilitating enrollment by helping beneficiaries understand 
materials and answering questions about available options. We decline 
to mandate that the beneficiary support system be part of a state's 
transition of care policy in Sec.  438.62 because the coordination of 
services during the transition period occurs between the state and the 
managed care plan or between managed care plans. Those entities will 
have the most relevant information and processes in place to 
communicate with one another to ensure that services are continued in 
accordance with the state's transition of care policy and the 
enrollee's needs.
    Comment: One commenter recommended that CMS revise the language at 
Sec.  438.71(c) to only require that choice counseling be made 
available to beneficiaries, not provided, since some beneficiaries will 
not be interested in such services.
    Response: We agree that not all beneficiaries will want to access 
choice counseling or beneficiary support system services in general, 
but we do not agree that modifying the language at Sec.  438.71(c) is 
necessary. We expect choice counseling to be available to all potential 
enrollees and enrollees who disenroll from a managed care plan, even if 
some enrollees ultimately do not seek such assistance. The beneficiary 
support system should make an effort to reach and support all 
beneficiaries in such situations.
    Comment: One commenter recommended that CMS add timeliness 
standards for the beneficiary support system and recommended that CMS 
include a requirement for beneficiary support system services to be 
available outside of regular business hours.
    Response: We agree with the commenter that timeliness in providing 
beneficiary support system services is important; however, we disagree 
that such prescriptive standards should be included in the regulation. 
We believe that states should consider such standards when developing 
and implementing their beneficiary support systems. States are in the 
best position to understand the unique characteristics of their 
programs and populations and should consider timeliness and 
availability standards as appropriate.
    Comment: Several commenters recommended that CMS clarify whether 
the beneficiary support system functions (for example, choice 
counseling and an access point for complaints) can be provided by 
different entities, or if CMS is requiring that all functions be 
performed by the same entity. Some commenters stated that additional 
beneficiary protections could result from the state choosing different 
entities for each function. One commenter recommended that states be 
provided with the flexibility to delegate certain aspects of the 
beneficiary support system to particular entities and not have one 
single beneficiary support system entity. Several commenters 
recommended that CMS allow states to build the beneficiary support 
system from existing programs and multiple entities that perform 
similar functions, such as the functions of Area Agencies on Aging, 
Marketplace Navigators, SHIPs, FQHCs, long-term care ombudsmen 
programs, and others. One commenter stated that CMS should explicitly 
separate choice counseling from the other beneficiary support 
functions.
    Response: We clarify for commenters that nothing in the regulation 
at Sec.  438.71 prohibits states from using different entities for 
different functions of the beneficiary support system, so long as the 
requirements of independence and freedom from conflicts of interest are 
met as incorporated into Sec.  438.71(c)(2). We believe that many 
states will choose multiple entities when developing and implementing 
their beneficiary support system and agree that there could be 
additional beneficiary protections realized if states choose this 
approach; however, we believe that states are in the best position to 
determine which beneficiary support system arrangements are most 
beneficial to their respective programs and populations and the unique 
structures of their health care and social service delivery systems.
    We remind commenters that states need not develop a new system if 
current structures meet all of the standards specified at Sec.  438.71. 
We maintain that the elements of the beneficiary support system 
specified represent the benchmark for the provision of independent 
information and supports for Medicaid enrollees that must be applied 
across all Medicaid managed care programs. States are permitted to draw 
upon and expand their current beneficiary support systems as necessary 
and applicable. We also encourage states to consider these programs and 
resources and to consult with a variety of stakeholders as they develop 
and implement their beneficiary support systems. However, the 
beneficiary support system should be built in a manner to ensure that 
the state can maintain appropriate oversight of the system and ensure 
ease of access for beneficiaries when accessing the system.
    We do not agree that choice counseling should be distinct from the 
beneficiary support system because choice counseling is an important 
form of beneficiary support. The state may select a distinct entity to 
provide choice counseling, subject to requirements in Sec.  
438.71(c)(2), from other entities that provide other elements of the 
beneficiary support system.
    Comment: Many commenters provided comments regarding the 
requirements at Sec.  438.71(c)(2) related to the independence and 
freedom from conflict of interest standards. Many commenters supported 
these proposed provisions and recommended that CMS preserve strong 
conflict of interest standards in the final rule, including prohibiting 
entities with a financial interest, such as a provider, in a managed 
care plan from also serving as either a choice counselor or a 
beneficiary support system entity. However, other commenters disagreed 
and stated that having a financial interest in a managed care plan 
should not disqualify entities from also providing choice counseling or 
other functions under the beneficiary support system. Several 
commenters that currently provide services similar to choice counseling 
supported through non-Medicaid federal grant funding stated it would be 
difficult to meet the Medicaid conflict of interest standards to 
provide Medicaid choice counseling under this rule.
    Response: We reiterate our position from the proposed rule at 80 FR 
31137 that any individual or entity providing choice counseling 
services on behalf of the state (which would be necessary to fulfill 
the requirements of this rule) is

[[Page 27628]]

considered an enrollment broker under our regulations, and therefore, 
must meet the independence and conflict of interest standards at Sec.  
438.810 to provide such services. We understand that the term 
``enrollment broker'' may have a different meaning in other programs, 
and we clarify that the requirements for independence and conflict of 
interest for enrollment brokers under Medicaid are specified in section 
1903(b)(4) of the Act. This means the entity cannot have a financial 
relationship with any managed care plan which operates in the state 
where the entity is providing choice counseling, which would also 
include the entity's participation with the managed care plan as a 
network provider. We also clarify that entities receiving non-Medicaid 
federal grant funding are not within the scope of this rule and 
therefore may continue to perform such activities as long as such 
entities are not performing these activities under a memorandum of 
agreement or contract with the state to provide choice counseling on 
the state's behalf. We believe that having a financial relationship or 
interest with a managed care plan can present the appearance of bias, 
even with safeguards in place. Therefore, we decline to make revisions 
to the regulation in this area. We note that our regulation at Sec.  
438.71(c)(3) does not provide otherwise and reflects a policy 
(described in more detail below) that is specific to states entering 
into agreements with entities that provide representation to Medicaid 
enrollees at hearings under non-Medicaid funding.
    Comment: Several commenters recommended that community-based 
organizations, Indian health care providers, and other representatives 
within the Indian Health System be exempt from the requirements at 
Sec.  438.71(c)(2) to be considered an enrollment broker if providing 
choice counseling services. Several commenters also noted that 
Marketplace Navigators are not required to meet such standards.
    Response: We reiterate our position that any individual or entity 
providing choice counseling services is considered an enrollment broker 
under our regulations that implement section 1903(b)(4) of the Act, and 
therefore, must meet the independence and conflict of interest 
standards at Sec.  438.810 to provide such services. This means the 
entity cannot have a financial relationship with any managed care plan 
which operates in the state where the entity is providing choice 
counseling. This includes participating with the managed care plan as a 
network provider. We also clarify that entities, including Indian 
Health providers and the Indian Health System, receiving non-Medicaid 
federal grant funding (distinct from Medicaid funding) may continue to 
perform such activities as long as such entities are not performing 
these activities under a memorandum of agreement or contract with the 
state to provide Medicaid choice counseling on the state's behalf. 
While we understand that Marketplace Navigators have different conflict 
of interest standards, it is not our intention to adopt the Marketplace 
Navigator program's conflict of interest standards for the beneficiary 
support system; the statutory basis and the specific standards for 
these programs are different.
    Comment: Several commenters stated that some governmental entities, 
typically counties, also serve as the managed care plan and provide 
choice counseling services. Some commenters recommended that CMS 
prohibit governmental entities from serving as both the managed care 
plan and the beneficiary support system, including choice counseling. 
Several commenters recommended that the beneficiary support system be 
fully independent of any state and/or local government, regardless of 
whether the state or county serves as the managed care plan. Other 
commenters recommended that CMS allow governmental entities to serve in 
both capacities as the managed care plan and the beneficiary support 
system, including choice counseling.
    Response: If a governmental entity is operating as the managed care 
plan, the conflict of interest requirements at Sec.  438.71(c)(2) and 
Sec.  438.810(b)(1) and (2) apply if the state seeks to use that entity 
to provide the choice counseling services required under this rule. 
Governmental entities that operate as the managed care plan would not 
be permitted to provide choice counseling to fulfill Sec.  438.71(c), 
as this is incompatible with the conflict of interest and independence 
standards.
    Comment: One commenter recommended that CMS clarify whether managed 
care plans can provide beneficiary support system activities, excluding 
choice counseling.
    Response: The beneficiary support system is designed to operate 
outside of the managed care plan and is not intended to replace the 
current resources that exist within managed care plans for 
beneficiaries to get information and assistance, including customer 
service. In fact, we expect the beneficiary support system to educate 
beneficiaries about managed care plan processes and resources and 
redirect them to the managed care plan when applicable. We also 
clarify, as the commenter noted, that it is impossible under statute 
and regulation for managed care plans to provide choice counseling, as 
this is incompatible with the conflict of interest and independence 
standards. We also believe that it is impossible for managed care plans 
to provide the LTSS-specific activities at proposed Sec.  438.71(e) 
(finalized as paragraph (d)). The beneficiary support system functions 
at proposed Sec.  438.71(e) (finalized as paragraph (d)) are intended 
to specifically assist beneficiaries with complex health needs who 
currently utilize or desire to receive LTSS. The beneficiary support 
system should serve as a general access point for complaints and 
concerns as described at proposed Sec.  438.71(e)(1) (finalized as 
paragraph (d)(1)), so that beneficiary support systems can educate 
enrollees and refer their concerns to the appropriate entities. This 
function is not intended to replace or act in lieu of the grievance and 
appeal process detailed at subpart F of 42 CFR part 438. Beneficiary 
support systems are intended to provide additional education and 
assistance in navigating the grievance and appeal process, including 
information on how to file a grievance or appeal with the managed care 
plan. Beneficiary support systems can also refer enrollees to sources 
of legal representation as appropriate. Therefore, we clarify for the 
commenter that it is not appropriate for any managed care plan to 
provide any of the beneficiary support system activities as specified 
at Sec.  438.71.
    Comment: Many commenters recommended revisions at Sec. Sec.  
438.71(d) and 438.71(b)(1)(ii) regarding the requirement for the 
beneficiary support system to provide training to MCOs, PIHPs, PAHPs, 
PCCMs, PCCM entities, and network providers on community-based 
resources and supports that can be linked with covered benefits. 
Several commenters supported the proposed provision but did not believe 
that the requirements went far enough; several commenters recommended 
that specific training for beneficiaries also be required. A few 
commenters also recommended that CMS require training for specific 
staff positions at managed care plans, such as care coordinators and 
those responsible for conducting person-centered planning. One 
commenter recommended that CMS require training for all new managed 
care plan staff and recommended annual training requirements. One 
commenter recommended that CMS require managed care plans to use the

[[Page 27629]]

SHIP training standards. Other commenters recommended that CMS require 
managed care plans to partner with or fund specific community-based 
organizations, such as Area Agencies on Aging.
    Several commenters also recommended that CMS require training to be 
linked to the goals in the person-centered plan and require training on 
the independent living and recovery philosophies.
    However, several other commenters also stated that the requirements 
of the beneficiary support system to train network providers went too 
far and recommended that the provision be removed, as beneficiary 
support system individuals and entities are not qualified to train 
network providers. Several commenters also stated that some managed 
care plans are opposed to the training requirements and recommended 
that training for managed care plans remain optional. A few commenters 
stated that the requirement to train managed care plans was overly 
burdensome.
    Response: After review of the comments and careful consideration, 
we believe that it is not appropriate to require the beneficiary 
support system to provide training to MCOs, PIHPs, PAHPs, PCCMs, PCCM 
entities, and network providers. Just as it is the responsibility of 
managed care plans to train their own staff, most managed care plans 
also have established training programs for network providers. We 
encourage managed care plans to include training related to the 
community-based support systems used by individuals with complex and 
special health care needs, including individuals using or needing LTSS. 
We also encourage managed care plans to work with their network 
providers regarding the best methods of accessing and coordinating the 
resources that are available to support beneficiaries in achieving 
better health outcomes. We also clarify that states have the 
flexibility to add specific training elements to their beneficiary 
support systems as appropriate in addition to the minimum standards in 
this regulation. We believe that states are in the best position to 
determine whether specific training elements are needed given their 
unique delivery systems to health care and social services and the 
needs of their covered populations. We are therefore not finalizing the 
regulatory text proposed at Sec.  438.71(b)(1)(ii) and Sec.  438.71(d); 
in this final rule, we redesignate the paragraphs following those 
proposed provisions accordingly.
    Comment: Several commenters stated that CMS should require the 
specific beneficiary support elements at proposed Sec.  438.71(e) (and 
finalized at Sec.  438.71(d)) to be available for all beneficiaries and 
not just those receiving LTSS. A few commenters recommended that the 
entire content of proposed (e) (finalized as paragraph (d)) should be 
moved to (b), while other commenters recommended that only those 
elements related to complaints, grievances, and appeals should be 
available to all beneficiaries.
    Response: The additional elements specified at proposed Sec.  
438.71(e) (and finalized at Sec.  438.71(d)) are intended to provide 
specific protections and safeguards for enrollees who use or desire to 
use LTSS. Enrollees using LTSS generally have more complex health needs 
than traditional managed care enrollees, and we believe LTSS enrollees 
would benefit most from these additional beneficiary support elements. 
We also recognize that states are increasingly looking to managed care 
delivery systems to support these complex populations, and we believe 
these additional elements are particularly beneficial in assisting 
enrollees who may be transitioning from a traditional LTSS program to 
an MLTSS program. The protections proposed at Sec.  438.71(e) 
(finalized as paragraph (d)) were intentionally focused on enrollees 
using LTSS, and we do not believe it is necessary to require these 
additional elements for all beneficiaries. However, we note that states 
have the flexibility to establish these additional elements for all 
populations in their respective programs as they deem appropriate.
    Comment: Several commenters stated concerns regarding possible 
beneficiary confusion surrounding the grievance and appeal process and 
the role of the beneficiary support system at proposed Sec.  438.71(e) 
(finalized as paragraph (d)). Commenters recommended that CMS clarify 
how the access point for complaints and concerns at proposed Sec.  
438.71(e)(1) (finalized as paragraph (d)(1)) would function and what 
relationship it has to the grievance and appeal process detailed at 
subpart F of this part. One commenter stated the importance of 
educating LTSS beneficiaries to the process of filing complaints, 
grievances, and appeals. Several commenters recommended that CMS 
require beneficiary support systems to establish networks and systems 
to ensure that representation at state fair hearings is available to 
LTSS beneficiaries.
    Response: The beneficiary support system is designed to operate 
outside of the managed care plan and is not intended to replace the 
current resources that exist within managed care plans for 
beneficiaries to access information and assistance, including customer 
service. In fact, we expect the beneficiary support system to educate 
beneficiaries about managed care plan processes and resources and 
redirect them to the managed care plan when applicable. The beneficiary 
support system functions at proposed Sec.  438.71(e) (finalized as 
paragraph (d)) are intended to specifically assist beneficiaries with 
complex health needs who currently utilize or desire to receive LTSS. 
This function is not intended to replace or act in lieu of the 
grievance and appeal process detailed at subpart F of 42 CFR part 438. 
We also clarify that beneficiary support systems are intended to 
provide additional education and assistance in navigating the grievance 
and appeal process, including information on how to file a grievance or 
appeal with the managed care plan; beneficiary support systems can 
refer enrollees to sources of legal representation as appropriate.
    Comment: Several commenters disagreed with the provision at 
proposed Sec.  438.71(e)(3) (finalized as paragraph (d)(3)) that 
prohibits the beneficiary support system from also representing the 
beneficiary during the grievance, appeal, and state fair hearing 
processes. Commenters stated that beneficiary support systems should be 
permitted to provide representation.
    Several commenters believed that entities that receive non-Medicaid 
funding to represent beneficiaries at hearings should also be permitted 
to provide choice counseling within the beneficiary support system with 
adequate firewalls in place as proposed at Sec.  438.71(e)(3)(i). Other 
commenters believed that such firewalls should not be permitted and 
recommended that such entities not be permitted to serve in both 
capacities for it is possible, even with firewalls in place, for an 
advocacy group that represents beneficiaries in the appeals and State 
fair hearing processes to have strong formed opinions about managed 
care plans that could cloud their impartiality in the provision of 
choice counseling services and result in inadvertent steering toward or 
away from a particular managed care plan.
    Response: The beneficiary support system is eligible for federal 
financial support as part of the Medicaid program as specified in 
Sec. Sec.  438.810 and 438.816 and legal representation is not among 
the activities eligible for FFP. Direct case advocacy for Medicaid 
beneficiaries under the Long Term Care Ombudsman Program is eligible 
for

[[Page 27630]]

Medicaid administrative funding as discussed at 80 FR 31137.
    We proposed at Sec.  438.71(e)(3)(i) a provision to permit a state 
to engage, for the purposes of providing choice counseling as required 
under this final rule at Sec.  438.71(a), an entity that receives non-
Medicaid funding to represent beneficiaries at hearings only if the 
state requires firewalls to ensure that the requirements for the 
provision of choice counseling are met and only in the context of LTSS-
specific activities. We are finalizing a similar provision at paragraph 
(c)(3) to permit such engagement in connection with firewalls for the 
provision of choice counseling generally.
    In response to comments received on this proposal, we believe that 
an entity that provides legal representation at hearings should 
generally not be permitted to also provide choice counseling on the 
state's behalf, unless the appropriate firewalls have been put in place 
to ensure that the entity can meet the requirements for choice 
counseling--namely, to provide the required information and assistance 
in an unbiased manner. We do not believe it is necessary to prohibit 
states from utilizing such entities for the provision of choice 
counseling under these conditions, and we will leave such decisions to 
the state's discretion. We are finalizing the firewall provision for 
entities that provide legal representation to provide choice counseling 
at paragraph (c)(3) to provide that this flexibility is directly 
related to choice counseling and not limited to LTSS-specific 
activities. Note that the provision of choice counseling makes the 
entity an enrollment broker and the memorandum of understanding or 
contract is subject to CMS review and approval per Sec.  438.810(b)(3); 
the independence and freedom of conflict of interest protections also 
apply. Therefore, we will finalize Sec.  438.71 with the substance of 
proposed paragraph (e)(3)(i) and finalized at paragraph (c)(3).
    Comment: Many commenters supported the provisions at Sec.  438.810 
regarding federal expenditures for enrollment broker services. One 
commenter recommended that CMS remove choice counseling from the 
definition of an enrollment broker at Sec.  438.810(a). One commenter 
recommended that CMS revise the term ``enrollment broker'' and use 
consumer friendly terminology to refer to persons who perform choice 
counseling or enrollment services. One commenter recommended that CMS 
clarify that enrollment activities and enrollment services include 
activities and services ``before and after enrollment'' into a managed 
care plan because the beneficiary support system is available to 
individuals before and after enrollment into a managed care plan.
    Response: We do not agree with commenters that we should separate 
choice counseling from the definition of enrollment broker. Consistent 
with our requirements at Sec.  438.71 and the existing rule at current 
Sec.  438.810, we clarify that any individual or entity providing 
choice counseling services on behalf of the state is considered an 
enrollment broker under our regulations, and therefore, must meet the 
independence and conflict of interest standards of Sec.  438.810 to 
provide those services. As noted in the proposed rule (80 FR 31137), we 
understand that some entities may receive federal grant funding 
(distinct from Medicaid funding) that may require those entities, such 
as FQHCs, Ryan White providers, or grantees (and sub-grantees) of the 
Title V Maternal and Child Health Block Grant, to conduct activities 
similar to those that would fall under the definition of choice 
counseling. We note here that such separate obligation to provide 
services similar to choice counseling services would not satisfy the 
state's obligation under Sec.  438.71(a). We also note that this is not 
an exhaustive list of federal grantees and is provided for illustrative 
purposes. If those entities do not have a memorandum of agreement or 
contract with the state to provide choice counseling on the state's 
behalf, such entities would not be required to adhere to the conflict 
of interest and independence standards in Sec.  438.810. We also note 
that some entities, such as FQHC look-alikes, as a condition of their 
federal designation, may be required to conduct activities similar to 
those that would fall under the definition of choice counseling. If 
those entities do not have a memorandum of agreement or contract with 
the state to provide choice counseling on the state's behalf, such 
entities would also not be required to adhere to the conflict of 
interest and independence standards in Sec.  438.810. The rule 
finalized here at Sec. Sec.  438.71 and 438.810 applies when the state 
engages--under a contract, memorandum of understanding, or other 
written agreement--an entity to provide these services in order to 
fulfill the state's obligations under Sec.  438.71(a) or claims FFP for 
the payment of those services under Sec.  438.810 or section 1903(b)(4) 
of the Act.
    We decline to revise the term ``enrollment broker'' as the statute 
uses this term in section 1903(b)(4) of the Act. We also clarify for 
the commenter that enrollment activities and enrollment services would 
include all activities and services consistent with the definitions at 
Sec.  438.810(a), including activities and services both before and 
after enrollment as applicable. The beneficiary support system offers 
resources and supports beyond the resources provided by an enrollment 
broker subject to Sec.  438.810. Therefore, it would not be appropriate 
to extend the definition of ``enrollment services'' or ``enrollment 
activities'' to include all functions of the beneficiary support system 
at Sec.  438.71.
    Comment: Many commenters supported the provisions at Sec.  
438.810(b)(1) and (2) regarding the conditions that enrollment brokers 
must meet. One commenter recommended that instead of the prescriptive 
independence and freedom from conflict of interest requirements at 
Sec.  438.810(b)(1) and (2), CMS allow state flexibility to determine 
any inherent bias during the state selection process. One commenter 
also recommended that CMS revise the freedom from conflict of interest 
requirements to include only the financial interests of direct or 
indirect ownership of the managed care plan.
    Response: We are bound by the statutory provision on enrollment 
brokers at section 1903(b)(4) of the Act. Sections 1903(b)(4)(A) and 
(B) of the Act specifically prohibit the availability of FFP for 
enrollment brokers who are not independent and free from conflict of 
interest. Therefore, we decline to adopt commenters' recommendations to 
either allow state flexibility to determine any inherent bias during 
the state selection process or to revise the freedom from conflict of 
interest requirements to include only the financial interests of direct 
or indirect ownership of the managed care plan. We believe that the 
language in section 1903(b)(4) of the Act, as reflected in Sec.  
438.810, is very specific about limitations as to who can serve as an 
enrollment broker. A broker is either independent of ``any'' managed 
care plan and of ``any health care providers'' that provide services in 
the state, or it is not. Similarly, a broker either does or does not 
have an owner, employee, consultant or other contract with a person who 
(1) has a direct or indirect interest in a managed care plan or 
provider, or (2) has been excluded, debarred, or subject to civil money 
penalties.
    Comment: One commenter recommended that CMS include requirements at 
Sec.  438.810 to require the use of evaluation tools and assessments to 
ensure that enrollment brokers are not engaging in self-referral or 
referrals

[[Page 27631]]

to organizations with whom they have a contracted interest.
    Response: We do not agree with the commenter that such a specific 
recommendation should be included in the regulatory text at Sec.  
438.810. We believe the current regulatory text is very specific and 
reflective of the statutory language at section 1903(b)(4) of the Act. 
While we encourage the use of evaluation tools and assessments to 
ensure that enrollment brokers are not engaging in self-referral or 
referral to organizations with whom they have an interest, as the 
existence of such arrangements would violate the conflict of interest 
provisions, states are in the best position to determine the exact 
tools and methods at their disposal to monitor the compliance of 
enrollment brokers.
    Comment: Many commenters supported Sec.  438.816 to permit FFP for 
the services outlined at proposed Sec.  438.71(e) (finalized as 
paragraph (d)). One commenter opposed the proposed provision and 
recommended state flexibility regarding the requirements at proposed 
Sec.  438.71(e) (finalized as paragraph (d)). One commenter recommended 
that CMS clarify whether the FFP match rate would be at the 
administrative match rate or the service match rate. One commenter 
recommended that CMS strike ``independent consumer support services'' 
in the section title and replace with ``the beneficiary support 
system,'' to be consistent with proposed Sec.  438.71(e).
    Response: We thank commenters for their support at Sec.  438.816. 
We decline to remove this provision, as proposed Sec.  438.71(e) 
(finalized as paragraph (d)) is not an optional requirement for states; 
therefore, it is necessary to include the applicable FFP for 
appropriate state expenditures that meet the conditions listed at (a) 
through (d) of Sec.  438.816. We clarify for commenters that the FFP 
match rate would be at the administrative match rate and not the 
service match rate. We agree with the commenter that striking 
``independent consumer support services'' in the section title and 
replacing with ``the beneficiary support system,'' to be consistent 
with proposed Sec.  438.71 is appropriate and are modifying the 
regulatory text to adopt this recommendation.
    Comment: One commenter recommended that CMS clarify the requirement 
at Sec.  438.816(a) regarding the state's approved Public Assistance 
Cost Allocation Plan in Sec.  433.34 of this chapter.
    Response: We clarify that a state plan under Title XIX of the Act 
must provide that the single or appropriate state agency will have an 
approved cost allocation plan on file with CMS in accordance with the 
requirements contained in subpart E of 45 CFR part 95. Consistent with 
the requirements at Sec.  95.505, a cost allocation plan means a 
narrative description of the procedures that the state agency will use 
in identifying, measuring, and allocating all state agency costs 
incurred in support of all programs administered or supervised by the 
state agency.
    After consideration of the public comments, we are not finalizing 
the regulatory text proposed at Sec.  438.71(b)(1)(ii) and (d). We are 
finalizing the remainder of the proposed rule at Sec.  438.71 with 
modifications. First, we are redesignating proposed paragraph (e) as 
Sec.  438.71(d). We are finalizing the firewall provision for entities 
that provide legal representation to provide choice counseling at 
paragraph (c)(3) to provide that this flexibility is directly related 
to choice counseling and not limited to LTSS-specific activities. We 
are also modifying the regulatory text at Sec.  438.816 to strike 
``independent consumer support services'' in the section title and 
replace with ``the beneficiary support system,'' to be consistent with 
proposed Sec.  438.71. We are finalizing the definition of ``choice 
counseling'' at Sec.  438.2 as proposed. We are finalizing Sec. Sec.  
438.810 and 438.816 largely as proposed, with grammatical corrections 
to the punctuation in Sec.  438.810(b)(1)(iii) and a revision of the 
heading at Sec.  438.816.
d. Coverage and Authorization of Services and Continuation of Benefits 
While the MCO, PIHP, or PAHP Appeal and the State Fair Hearing are 
Pending (Sec. Sec.  438.210 and 438.420)
    We grouped our discussion of proposals for Sec. Sec.  438.210 and 
438.420 because they address related benefit issues about the receipt 
and provision of covered services. Section 438.210 establishes 
standards for authorization periods set by managed care plans and Sec.  
438.420 addresses the duration of continued benefits pending appeal 
resolution. Although the current regulation at Sec.  438.210 addresses 
MCOs, PIHPs, and PAHPs, the current regulation at Sec.  438.420 
addresses only MCOs and PIHPs. We proposed to add PAHPs to the subpart 
F appeal and grievance regulations as discussed in the Appeals and 
Grievance section of the proposed rule (I.B.1.b.).
    Under existing regulations, continuation of benefits during an 
appeal is tied to coverage and authorization decisions made by the MCO, 
PIHP, or PAHP. As more managed care programs include enrollees with 
ongoing and chronic care needs, including LTSS, we believe it is 
important that authorization periods for such services reflect the 
ongoing need for these services to avoid disruptions in care.
    While we recognized that MCOs, PIHPs, and PAHPs have flexibility in 
applying utilization management controls for covered services, 
exercising that flexibility could result in the inappropriate 
curtailment of necessary services, particularly for those requiring on-
going and chronic care services, including LTSS. We acknowledged that 
our current standards reflect an acute care model of health care 
delivery and do not speak to the appropriate medical management of 
individuals with ongoing or chronic conditions, or the authorization of 
home and community based services that maximize opportunities for 
individuals to have access to the benefits of community living and the 
opportunity to receive services in the most integrated setting. 
Therefore, we proposed to modernize the language in Sec.  438.210 
governing the coverage and authorization of services and establish 
standards for states to ensure through the managed care contract that 
MCOs, PIHPs, and PAHPs employ utilization management strategies that 
adequately support individuals with ongoing or chronic conditions or 
who require LTSS.
    As background, the foundation of coverage and authorization of 
services is that services in Medicaid must be sufficient in amount, 
duration, or scope to reasonably be expected to achieve the purpose for 
which the services are furnished, and services must not be arbitrarily 
denied or reduced because of the diagnosis or condition of the 
enrollee. Our proposal was to permit an MCO, PIHP, or PAHP to place 
appropriate limits on a service on the basis of criteria applied under 
the state plan, such as medical necessity or for the purpose of 
utilization control, provided that the services furnished can 
reasonably achieve their purpose. This is the same standard applied to 
a state's coverage decisions under the state plan. See Sec.  440.230. 
We proposed to reflect this by revising pertinent text in Sec.  
438.210(a)(3)(1) to delete ``be expected to'' as it is used relative to 
services reasonably achieving their results and align with the FFS 
standard in Sec.  440.230.
    We proposed no changes to Sec.  438.210(a)(1) and (2).
    We proposed that existing paragraph (a)(3)(iii) be redesignated as 
(a)(4) and existing paragraphs (a)(3)(iii)(A) and (B)

[[Page 27632]]

be redesignated without change as paragraphs (a)(4)(i) and (ii), with 
new paragraphs added at (a)(4)(ii)(A), (B) and (C). In paragraph 
(a)(4)(ii)(A), we proposed text to incorporate the proposed revisions 
in paragraph (a)(3)(i) deleting the phrase ``to be expected to'' as it 
is used relative to services reasonably achieving their purpose in 
stating a limit on how utilization controls may be used. We also 
proposed to add two new conditions on when and how an MCO, PIHP, or 
PAHP may impose utilization controls. First, we proposed in paragraph 
(a)(4)(ii)(B) that the state must ensure, through its contracts, that 
service authorization standards are appropriate for and do not 
disadvantage those individuals that have ongoing chronic conditions or 
need LTSS. The proposal would require that clinical services that 
support individuals with ongoing or chronic conditions, as well as LTSS 
would be authorized in a manner that reflects the beneficiary's 
continual need for such services and supports. As this would be a 
contractual standard for managed care programs that cover both medical 
and LTSS, we stated our expectation that states monitor MCO, PIHP, and 
PAHP compliance with setting reasonable authorization periods, and also 
proposed a requirement for monitoring utilization management in our 
proposed revisions to Sec.  438.66(b)(8). Second, we proposed that 
utilization controls may not interfere with the enrollee's freedom to 
choose a method of family planning. Specifically, we proposed that 
utilization controls are permissible so long as family planning 
services are provided in a manner that protects the enrollee's freedom 
to choose the method of family planning to be used consistent with 
Sec.  441.20. We proposed this language under to our authority under 
section 1902(a)(4) of the Act; our proposal was intended to ensure that 
all beneficiaries, whether receiving family planning services through 
FFS or managed care, have the same freedom to choose the method of 
family planning to be used. This proposal would not alter the state's 
ability under FFS or a managed care plan's ability to apply medical 
necessity criteria for an individual's request for family planning 
services but prohibited utilization controls that would interfere with 
an enrollee's freedom to choose the method of family planning. We 
requested comment on this proposal.
    We proposed that existing paragraph (a)(4) be redesignated as 
(a)(5) and paragraph (a)(5)(i) remained unchanged. In paragraph 
(a)(5)(ii), we proposed to revise the criteria for defining medically 
necessary services by adding that such criteria must meet the 
requirements for providing the early and periodic screening and 
diagnosis and treatment (EPSDT) benefit beneficiaries under age 21. We 
believed this addition was necessary to ensure that managed care plans 
that provide the EPSDT benefit use definitions of medical necessity 
that comply with federal EPSDT laws. In paragraph (a)(5)(iii)(A), we 
proposed to revise the criteria for defining medically necessary 
services by replacing ``health impairments'' with ``an enrollee's 
disease, condition, or disorder that results in health impairment and/
or disability'' because the change more accurately reflected our intent 
than the existing text. In paragraph (a)(5)(iii)(A) through (C), we 
proposed grammatical revisions to accommodate a proposed new paragraph 
(a)(5)(iii)(D) that would add an LTSS focus by requiring that medically 
necessary services address the opportunity for an enrollee to have 
access to the benefits of community living.
    In paragraph (b), we proposed to add specificity related to LTSS 
services. No changes were proposed for (b)(1) and (2)(i); however, in 
(b)(2)(ii) we proposed to add ``for medical services'' to address 
requests for non-LTSS, and in paragraph (b)(2)(iii), we proposed to add 
a standard that MCOs, PIHPs, and PAHPs authorize LTSS based on an 
enrollee's current needs assessment and consistent with the person-
centered service plan. In paragraph (b)(3), we proposed to change the 
text from ``treating the enrollee's condition or disease'' to 
``addressing medical, behavioral health, or long term services and 
supports needs.''
    We proposed the changes in paragraph (c) to add ``PAHP'' to the 
standards of this paragraph and to revise ``notice of adverse action'' 
to ``notice of adverse benefit determination.'' In paragraph (c), we 
also proposed to correct the heading to reflect the change from 
``action'' to ``adverse benefit determination.'' As discussed in 
section I.B.1.b. of this final rule, we proposed to add PAHPs to 
subpart F and replace ``action'' with ``adverse benefit determination'' 
throughout 42 CFR part 438.
    We also proposed to remove the provision that referenced notices to 
providers of adverse benefit determinations need not be in writing as 
an exception to Sec.  438.404. Provider notices are not currently 
addressed in Sec.  438.404, thus this reference is erroneous.
    The only change proposed to paragraph (d)(1) was to delete 
``health'' to use the more comprehensive term ``condition''.
    We proposed in Sec.  438.210(d)(2)(i) and (ii) to change the 
timeframe for MCOs, PIHPs, and PAHPs to make expedited authorization 
determinations within 72 hours, rather than the current standard of 3 
working days, after receipt of the request for the service to align 
expedited authorization determination timeframes with the expedited 
managed care plan level of appeal in proposed Sec.  438.408(b)(3). We 
discuss in section I.B.1.b. of this final rule how these proposed 
timelines align with the MA and private market standards for expedited 
appeals. We did not propose any revisions to Sec.  438.210(e).
    In section Sec.  438.420, we proposed conforming revisions, 
consistent with other proposals throughout subpart F: specifically, to 
change ``action'' to ``adverse benefit determination,'' to add PAHPs to 
standards currently applicable only to MCOs and PIHPs, and to specify 
all time limits expressed in days as calendar days. To address the 
limit on enrollee's access to benefits pending resolution of an appeal, 
we also proposed to eliminate the link between the duration of 
continued benefits pending appeal and the original service 
authorization period. Thus, we proposed to delete existing Sec.  
438.420(c)(4) that permits MCOs and PIHPs to discontinue coverage of 
services pending appeal when the time period or service limits of a 
previously authorized service has been met. The removal of this 
paragraph would mean that an enrollee must continue to receive benefits 
without interruption, if the enrollee elects to continue benefits, 
through the conclusion of the appeal and state fair hearing process if 
the enrollee appeals an MCO's, PIHP's, or PAHP's adverse benefit 
determination. This change would apply to all authorized services 
covered by the MCO, PIHP, or PAHP. We indicated that this proposal 
represented a critical enrollee protection given the nature and 
frequency of many ongoing services, particularly for enrollees 
receiving LTSS.
    In addition, in Sec.  438.420(d), we proposed that the MCO's, 
PIHP's, or PAHP's ability to recoup the cost of such continued benefits 
from the beneficiary under a final adverse decision be addressed in the 
contract and that such practices be consistent across both FFS and 
managed care delivery systems within the state. Under both managed care 
and FFS, the right to continuation of benefits is not exercised without 
potential financial risk to the beneficiary for payment for services 
provided if the final decision is adverse

[[Page 27633]]

to the beneficiary. Rather, the decision to hold the beneficiary 
financially liable for such services is left to the state under Sec.  
431.230(b) and that decision would be applied equally to FFS and 
managed care programs. For example, if the state does not exercise the 
authority for recoupment under Sec.  431.230(b) for FFS, the same 
practice must be followed by the state's contracted MCOs, PIHPs, and 
PAHPs. We requested comments on the proposed revisions to Sec. Sec.  
438.210 and 438.420.
    We received the following comments in response to our proposal to 
revise Sec.  438.210.
    Comment: Many commenters supported the proposed revisions to Sec.  
438.210. Commenters believed that proposed Sec.  438.210 added needed 
specificity and clarity. Commenters were particularly supportive of the 
addition to LTSS throughout.
    Response: We thank the commenters for their support.
    Comment: One commenter recommended that CMS address the prohibition 
on discrimination under section 1557 of the Affordable Care Act in 
Sec.  438.210. The commenter believed that most services that are not 
covered or authorized for transgender persons are already covered for 
cisgender persons.
    Response: As required in Sec.  438.3(f)(1), all managed care 
contracts must comply with all applicable federal and state laws and 
regulations including Title VI of the Civil Rights Act of 1964; Title 
IX of the Education Amendments of 1972 (regarding education programs 
and activities); the Age Discrimination Act of 1975; the Rehabilitation 
Act of 1973; the Americans with Disabilities Act of 1990 as amended; 
and section 1557 of the Patient Protection and Affordable Care Act. We 
do not believe revisions are necessary in the final rule to further 
address the prohibition on discrimination.
    Comment: One commenter recommended that ``health'' be inserted in 
front of ``condition'' in proposed Sec.  438.210(a)(5)(ii) and another 
commenter provided the same recommendation for proposed Sec.  
438.210(a)(5)(iii)(A). The commenters believed the removal of the word 
``health'' made ``condition'' overly broad.
    Response: We understand the commenters' concern but decline to add 
``health'' to ``condition'' in those provisions. We specifically 
proposed this change to acknowledge the increasing inclusion of the 
LTSS population in managed care and the non-medical nature of many of 
their needs and services.
    Comment: A few commenters requested that court ordered services be 
considered as medically necessary.
    Response: We decline to add compliance with court orders as an 
exception in Sec.  438.210 as this section applies to the managed care 
plan's coverage and authorization of services in the normal course of 
business. The managed care plan's compliance with court orders is a 
matter to be addressed through the contract or through consultation 
with legal counsel.
    Comment: One commenter recommended that proposed Sec.  
438.210(a)(2)(i) be amended to require that states that offer self-
direction in their FFS LTSS programs are expected to continue them 
under MLTSS.
    Response: There are enrollee protections in Sec.  438.210(a) 
regarding the amount, duration, and scope of services. Additionally, as 
part of the stakeholder engagement process in Sec.  438.70, states 
should consider the impact of altering the types of services available 
to enrollees under a MLTSS program. However, states have the 
flexibility to design a MLTSS program and it may differ from the 
program that was operated under FFS. Including self-direction in a 
MLTSS program remains a state decision.
    Comment: One commenter suggested that there should no limits 
permitted on amount, duration, and scope as proposed in Sec.  
438.210(a)(1).
    Response: Proposed Sec.  438.210(a)(2) provides that services 
identified in paragraph (a)(1) of this section be furnished in an 
amount, duration, and scope that is no less than the amount, duration, 
and scope for the same services furnished to beneficiaries under FFS 
Medicaid. We believe this is an appropriate limitation, but are 
clarifying that any limits must be consistent with the approved state 
plan and Sec.  440.230 and decline to completely remove the managed 
care plans' ability to define the amount, duration, and scope of 
covered services.
    Comment: A few commenters recommended that CMS set national 
utilization management standards and/or authorization criteria for 
managed care plans in proposed Sec.  438.210(a) and (b). The commenters 
believed this would add consistency among states and eliminate the use 
of standards and criteria based on a managed care plan's other line of 
business, such as the private market.
    Response: We do not believe it appropriate for us to set the 
utilization management standards and/or authorization criteria for 
managed care plans. The provisions in Sec.  438.210(a) and (b) do 
provide a sufficient level of detail and will provide adequate 
consistency across states. We believe states and managed care plans 
have the expertise and experience to develop the specific standards and 
criteria that best meet the needs of their program.
    Comment: We received several comments recommending that managed 
care plans be required to regularly review, update, and publish their 
utilization management criteria. Commenters believed this would ensure 
that the most current industry information is used to make decisions 
and that, making this information public would be beneficial to 
providers and those assisting beneficiaries.
    Response: We agree that utilization management policies and 
procedures should be regularly reviewed and updated. However, we 
believe this is already occurring and that no specific requirement for 
this is needed in Sec.  438.210. We are confident that managed care 
plans appreciate the importance of keeping the information used in 
their utilization management activities as current as possible and take 
appropriate steps to maintain it. The extent to which utilization 
management policies and procedures are routinely published is a 
decision best made by the managed care plan or addressed by the state 
in the contract.
    Comment: A few commenters recommended that the proposed provisions 
relative to utilization management be removed as managed care plans 
have the experience and expertise needed to develop and implement 
utilization management processes without additional federal 
requirements.
    Response: We believe that the proposed provisions set an 
appropriate level of detail while still preserving the managed care 
plans' ability to utilize its expertise to operate and manage its 
business. States choose to contract with managed care plans to improve 
and expand their programs as well as enable the program to provide 
additional services, benefits, and provider networks to their 
beneficiaries. We believe that Sec.  438.210, with the proposed changes 
and as finalized here, provides consistency and clarity on program 
expectations without being an impediment to effective and efficient 
managed care plan operations.
    Comment: We received a few comments recommending that CMS add a 
reference to parity standards in proposed Sec.  438.210 since it 
establishes a relationship between authorizations and utilization 
management used for medical benefits and those used for behavioral 
health and substance use disorder.

[[Page 27634]]

    Response: We do not agree that a reference to parity standards are 
necessary in Sec.  438.210. The implementing regulations for mental 
health parity are addressed in the March 30, 2016 final rule (81 FR 
18390) and will be codified in a new subpart K in part 438 when 
effective. Subpart K will address authorizations and utilization 
management relative to compliance with MHPAEA.
    Comment: We received several comments on proposed Sec.  
438.210(a)(4) that recommended that CMS specify that managed care plans 
may not use utilization control criteria that require an enrollee to 
show improvement to continue receiving services; require managed care 
plans to prioritize safe and effective treatments, and deliver care in 
a manner that is the least intrusive and restrictive, consistent with 
the level of care that is clinically appropriate for enrollees; and 
require managed care plans to consider individual factors, including 
tolerance for side effects, differences in treatment types, and the 
patient's ability to adhere to the recommended treatment regimen during 
the utilization review process.
    Response: We do not agree that we should specify utilization 
control criteria Sec.  438.210 to the level of detail requested. We 
believe managed care plans try to apply service authorizations 
appropriately based on enrollee needs; further, when the enrollee 
believes there have been inappropriate changes made to the level of 
services, the enrollee has the benefit of the grievance and appeal 
system. We encourage managed care plans to consider including 
prioritizing safe and effective treatments, delivering care in a manner 
that is medically appropriate while the least intrusive and 
restrictive, and individual factors (including tolerance for side 
effects, differences in treatment types, and the patient's ability to 
adhere to the recommended treatment regimen) in the development and 
implementation of their authorization policies and procedures.
    Comment: We received one comment that recommended changing the word 
``reflects'' to ``meets'' in Sec.  438.210(a)(4)(ii)(B) which currently 
states that the services supporting individuals with ongoing or chronic 
conditions or who require LTSS are authorized in a manner that reflects 
the enrollee's ongoing need for such services and supports.
    Response: We appreciate the commenter's suggestion but do not 
believe ``meets'' clarifies or strengthens the provision. We are 
retaining ``reflects'' in the final rule.
    Comment: We received one comment requesting that ``as permitted in 
the covered services list'' be added to proposed Sec.  
438.210(a)(4)(ii)(B).
    Response: We do not believe that a revision is necessary. We did 
not intend to imply in proposed Sec.  438.210(a)(4)(ii)(B) that a 
managed care plan was expected to provide services outside the scope of 
services specified by the state in the managed care plan's contract. 
This is true of all provisions in part 438, unless superseded by state 
or federal law.
    Comment: Some commenters recommended that proposed Sec.  
438.210(a)(4)(ii)(C) be revised to further clarify that the managed 
care plan cannot impose limitations on family planning services.
    Response: The intention of Sec.  438.210(a)(4)(ii)(C) was to ensure 
that the provision of family planning services was consistent between 
FFS and managed care delivery systems and the incorporation of Sec.  
441.20 in this paragraph would accomplish that goal. The plain language 
of Sec.  441.20 means that for medically necessary and utilization-
appropriate services, the state cannot preclude individuals from having 
a choice of the method of family planning services. The state or 
managed care plan cannot dictate that a particular method be used first 
or impose a prior authorization requirement that involves anything 
other than the determination that the method is medically necessary and 
utilization-appropriate. Other types of prior authorization or 
utilization management policies would effectively deprive the 
beneficiary or enrollee of free choice of equally appropriate 
treatments.
    Comment: Some commenters that recommended modification to proposed 
Sec.  438.210(a)(5)(i) to clarify that medical necessity definitions 
should be no more restrictive than the FFS definition in terms of 
either quantitative or non-quantitative treatment limits.
    Response: We agree with commenters. The regulation already requires 
that medical necessity definitions be no more restrictive than state 
law, the state plan, and other state policies and procedures for the 
Medicaid program; this necessarily includes the extent to which medical 
necessity definitions contain limits on coverage. Further, the 
longstanding requirement for MCOs, PIHPs, and PAHPs to cover services 
under the contract in an amount, duration and scope that is no less 
than the amount, duration and scope for the services under the state 
plan would apply as well to such limits. Therefore, we will add 
``quantitative and non-quantitative treatment limits'' to the final 
text in Sec.  438.210(a)(5)(i).
    Comment: We received many comments in support of our proposed 
addition of Sec.  438.210(a)(5)(ii) addressing EPSDT requirements for 
enrollees under 21 years of age. We also received comments recommending 
that ``chronic'' be removed as it is not included in the definition in 
section 1905(r)(5) of the Act and ``defects'' be removed as it is 
considered by some to be a poor choice of words. One commenter 
suggested that CMS clarify that EPSDT requires coverage for services 
even though they may otherwise not be covered, while another commenter 
suggested that CMS clarify that when services not covered by the 
managed care plan's contract need to be covered, the state is 
responsible for coverage of the services. Some commenters recommended 
that CMS remove the reference to EPSDT proposed in Sec.  
438.210(a)(5)(ii) as part of the definition of medical necessity to 
safeguard against unintended consequences and that the reference could 
be interpreted to apply the requirements of EPSDT to enrollees over 21 
years of age, as well as be interpreted to mean that medical necessity 
criteria could not be applied to EPSDT.
    Response: In considering the diversity of the comments received on 
this provision, we realized that the proposed reference to EPSDT in 
Sec.  438.210(a)(5)(ii) was not clear. Implying that medical necessity 
criteria could not be applied to EPSDT services or that EPSDT 
requirements should be applied to adult enrollees was not our intent. 
To correct this, we are moving the reference to EPSDT from Sec.  
438.210(a)(5)(ii) and are adding text to Sec.  438.210(a)(2) which 
addresses coverage for children more broadly as part of the requirement 
that managed care plan coverage be no less than the amount, duration, 
and scope of coverage under the state plan for covered services; we are 
finalizing new text that states enrollees under the age of 21, as set 
forth in subpart B of part 441 of this chapter at the end of the 
paragraph. We believe these revisions will facilitate consistent 
understanding of this provision. Questions regarding the managed care 
plan's responsibility for coverage of services not covered by the 
contract, should be directed to the state for clarification as that is 
outside the scope of this rule. We are redesignating the paragraphs at 
Sec.  438.210(a)(5)(i)-(ii) to reflect this change as well.
    Comment: We received one comment recommending that compliance with 
state periodicity schedules for screenings and assessments should be

[[Page 27635]]

identified as part of ``the extent to which the managed care entity 
covers services,'' proposed in Sec.  438.210(a)(5)(iii)(A).
    Response: States and managed care plans are welcome to include 
references to compliance with state periodicity schedules within their 
definition of medically necessary services as they deem appropriate and 
necessary. We decline to add a reference to the final policy of 
proposed Sec.  438.210(a)(5)(iii)(A), which we are redesignating as 
Sec.  438.210(a)(5)(ii)(A).
    Comment: We received several comments on proposed Sec.  
438.210(a)(5)(iii)(D) related to the opportunity for an enrollee 
receiving long term services and supports to have access to the 
benefits of community living. Commenters believed this provision could 
be strengthened by references to person centered goals and living in 
the setting of their choice. Other commenters believed there was 
ambiguity in the word ``opportunity.''
    Response: We agree that this provision could be strengthened and 
will be making some revisions; however, we will be retaining 
``opportunity'' as LTSS also includes institutional care and we believe 
``opportunity'' appropriately signals the need to provide access to 
home and community based services (HCBS) without requiring it for those 
who need institutional care. We are finalizing Sec.  
438.210(a)(5)(ii)(D) to state that the opportunity for an enrollee 
receiving LTSS to have access to the benefits of community living, 
achieve person-centered goals, and live and work in the setting of 
their choice. We believe this final text adequately captures the goals 
of LTSS as they should be used to make medical necessity 
determinations.
    Comment: One commenter suggested CMS require the inclusion of 
community providers in the development of the managed care plan's 
definition of ``medically necessary services'' and another commenter 
recommended that CMS require managed care plans to include a quality of 
life principle in their definition.
    Response: We agree with both commenters that the input of community 
providers or other stakeholders in the managed care plan's development 
of medical necessity criteria could be of value, as well as the 
addition of a quality of life component; however this level of 
specificity is not warranted in this regulation. We decline to add that 
to the regulation text we are finalizing at Sec.  438.210(a)(5).
    Comment: We received many comments on proposed Sec.  438.210(b). 
One commenter believed that authorization requirements should not be a 
burden on providers; another believed the prescriber of treatment 
should determine the purpose of the service, rather than the managed 
care plan's staff; another believed authorization staff at the managed 
care plan should be available 24/7; another believed that authorization 
staff should be available to discuss decisions by phone; another 
believed managed care plans should have to use the same authorization 
criteria as the state; and another commenter believed that managed care 
plans should be prohibited from using criteria used in private market 
insurance and group health plans.
    Response: We appreciate the commenters' concerns that an 
appropriate balance among many factors (physician independence in 
exercising medical judgment, enrollee access to services, 
administrative responsibilities of the plan, etc.) must be struck when 
authorizing services, but decline to include the recommended changes in 
the final rule at Sec.  438.210(b). We encourage managed care plans to 
consider the burden on and input from providers and the prescribers 
when developing their authorization processes. States and managed care 
plans should consider the feasibility of extended hours for 
authorization staff, as well as the sharing of authorization criteria. 
Managed care plans utilize many sources of information when developing 
their authorization policies and we believe that the criteria and 
processes currently used to make authorization decisions for the 
Medicaid population are appropriately evaluated and determined 
appropriate prior to use.
    Comment: A few commenters recommended the inclusion of a new Sec.  
438.210(b)(3) addressing ``reauthorizations.'' The commenters suggested 
regulation text related to the timing of authorization requests and 
requirements on providers for submitting requests for authorization.
    Response: It is unclear what situations the commenters are 
referencing when they address ``reauthorizations'' as the term is not 
used in part 438. We believe the commenters may be referencing a 
request for authorization of the same services that have previously 
been authorized for an enrollee. However, a request for additional 
services beyond the termination date of an authorization is not a 
reauthorization of a benefit, it is a new request for authorization of 
services. For a more complete explanation of continuation of benefits, 
we direct the commenters to the discussion of Sec.  438.420 below.
    Comment: We received one comment recommending that CMS issue a 
clear and detailed process for notice to providers and all members of 
the care team for authorization decisions in Sec.  438.210(c). Another 
commenter requested that CMS provide clarity on the appropriate methods 
for notification of authorization decisions to providers.
    Response: We decline to specify this level of detail in Sec.  
438.210(c). We believe that managed care plans already have 
notification methods included in their policies and utilize them daily. 
We encourage providers to collaborate with the managed care plans to 
determine the most efficient and effective communication methods. Upon 
review of the proposed text at Sec.  438.210(c), however, we noticed 
that punctuation is missing and that a technical correction is 
necessary; we are finalizing the last sentence as, ``For MCOs, PIHPs, 
and PAHPs, the enrollee's notice must meet the requirements of Sec.  
438.404.''
    Comment: Some commenters suggested changes to the notification 
timeframes for standard and expedited authorizations as proposed in 
Sec.  438.210(d)(1) and (2). Some commenters supported the change from 
3 working days to 72 hours for expedited authorizations, while others 
believed the proposed deadline would be difficult, if not impossible, 
to meet. A few commenters suggested alternative time frames such as 1 
day for standard authorizations and 1 hour for expedited 
authorizations; another commenter suggested 3 business days for 
standard authorizations and 24 hours for expedited authorizations. One 
commenter suggested 24 hours from receipt of all necessary information 
for expedited requests. One commenter recommended that a cross 
reference to Sec.  438.3(s)(6) be added since that also addresses an 
authorization time frame for covered outpatient drugs.
    Response: We appreciate the comments on our proposed timeframes in 
Sec.  438.210(d)(1) and (2). While we understand that transitioning 
from 3 business days to 72 hours may be difficult, we believe that it 
not only is in the best interest of the enrollees, but that many 
managed care plans will recognize efficiencies if they also provide MA 
and/or private market coverage. The 72 hour timeframe for expedited 
authorizations is the prevailing standard in those markets for 
expedited determinations and appeals and we do not see a compelling 
reason to treat Medicaid managed care plans differently. In addition, 
we decline to modify the timeframe for standard authorizations. We 
agree with the commenter that adding a reference to

[[Page 27636]]

the timeframes for responding to authorization requests reflected in 
Sec.  438.3(s)(6) would make Sec.  438.210(d) more complete. 
Accordingly, we will add a new paragraph (d)(3) with a reference to the 
timeframe for responding to prior authorization requests for covered 
outpatient drugs in section 1927(d)(5)(A) of the Act.
    Comment: One commenter requested that CMS clarify that enrollees 
need not request that an authorization decision be handled as 
expedited.
    Response: We agree that an enrollee is not responsible for 
requesting expedited handling of an authorization request, but maintain 
that Sec.  438.210(d)(2)(i) is sufficiently clear as it references the 
ability of the provider to indicate the need for an expedited 
authorization or the MCO, PIHP, or PAHP to make such determinations. We 
expect that the need for an expedited determination would be reflected 
in the records used to make an authorization determination.
    We received the following comments in response to our proposal to 
revise Sec.  438.420.
    Comment: We received many comments in support of the deletion of 
paragraph (c)(4) in proposed Sec.  438.420. The commenters believed 
that requiring services to be continued during an appeal and/or state 
fair hearing was a critical enrollee protection particularly for 
enrollees receiving services for chronic conditions or LTSS.
    Response: We thank the commenters for their support for the 
proposed deletion of paragraph (c)(4).
    Comment: One commenter requested that CMS include the contents for 
the notice of adverse benefit determination in Sec.  438.420(a)(i).
    Response: The content requirements for a notice of adverse benefit 
determination is contained in Sec.  438.404(b)(6), as proposed and 
finalized. We believe that is the appropriate location for that 
information and decline to repeat it in Sec.  438.420.
    Comment: A few commenters recommended that a managed care plan's 
ability to recoup the cost of services be eliminated if the managed 
care plan did not provide the notice of adverse benefit determination 
in the appropriate non-English language for enrollees that are limited 
English proficient or in the appropriate format to meet the needs of an 
enrollee with a disability.
    Response: We understand the commenter's concern that notices for 
enrollees be understandable but believe we have adequately addressed 
this in Sec.  438.10(d)(3) based on comments and revisions to that 
section. Proposed Sec.  438.10(d)(3) is revised to add denial and 
termination notices to the list of documents that must be made 
available in prevalent non-English languages, as well as in alternative 
formats. We believe there is an additional protection in Sec.  
438.10(d)(3) since we added critical to obtaining services in this 
final rule; (see section I.B.6.d.) we believe that any notice to an 
enrollee concerning a denial, termination, reduction, or suspension of 
services is critical. We remind managed care plans that any necessary 
translation or alternative formats must be completed in a manner that 
does not impede the enrollee's ability, or reduce the enrollee's time, 
to request continuation of benefits in order to comply with Sec.  
438.10.
    Comment: A few commenters requested clarification on the guidance 
provided in the preamble for part 438 when finalized in 2002 (67 FR 
41058) that addressed the difference between continuing benefits of a 
previously authorized service and a new request for the same service. 
Some commenters believed the proposed Sec.  438.420 was implying that 
CMS was taking a different position on the question of whether the 
expiration of a previously authorized course of treatment constitutes a 
``termination'' of that course of treatment.
    Response: We appreciate the opportunity to clarify that it was not 
our intention to imply a new meaning to ``termination'' in proposed 
Sec.  438.420. Consistent with the 2002 preamble, the request for days 
or services (whether the same or different) in addition to the original 
authorization should be treated by the MCO, PIHP, or PAHP as a new 
request for service authorization; denials or limitations, if issued, 
must be provided in accordance with Sec.  438.404. If additional days 
or services were not authorized, ending treatment as provided in the 
original authorization would not constitute a termination triggering 
the right to continued benefits. For purposes of the continuation of 
benefits under this regulation, however, the removal of paragraph 
(c)(4) means that an enrollee must continue to receive benefits without 
interruption, if elected by the enrollee, through the conclusion of the 
SFH process if the enrollee appeals an MCO's, PIHP's, or PAHP's adverse 
benefit determination.
    Comment: One commenter recommended that a provision be added to 
require states to develop an effective and consistent process for 
notifying the managed care plan when one of their enrollees has 
requested a state fair hearing. The commenter believes that without 
this, managed care plans may inadvertently allow authorizations to 
lapse simply because they were unaware that the enrollee had filed for 
a state fair hearing.
    Response: We agree with the commenter's concern and encourage all 
states to review their policies and procedures for notifying their 
managed care plans of a request for a state fair hearing and ensure 
that they are appropriately implemented in a manner that does not cause 
a disruption in the enrollee's care. However, we do not believe that 
revisions to our proposal are necessary.
    Comment: A few commenters recommended that CMS add ``course of 
treatment or'' to Sec.  438.420(b)(3) before ``services.''
    Response: We believe that a course of treatment is made up of 
individual services; therefore, adding it to Sec.  438.420(b)(3) before 
``services'' does not change or enhance the meaning. We decline to make 
this suggested revision. However, for consistency, we will revise Sec.  
438.420(b)(2) to use ``previously authorized services'' in place of 
``previously authorized course of treatment.''
    Comment: Some commenters recommended that proposed Sec.  
438.420(b)(4), which provides that one of the conditions for 
continuation of benefits is that the original authorization period has 
not expired, be deleted. These commenters did not believe that 
enrollees should have to request continuation of benefits prior to the 
end of the original authorization period, particularly given that 
enrollees sometimes miss that deadline simply because the managed care 
plan did not provide the notice as far in advance as required. Some 
commenters also believed that the removal of existing paragraph (c)(4) 
related to the duration of continuation of benefits makes proposed 
paragraph (b)(4) unnecessary.
    Response: We believe that revisions to Sec.  438.420 are warranted 
to make our intent clearer. As the revisions impact paragraphs (a) and 
(b) of this section, we will address the interactions among these 
requirements and modifications in detail. First, the defined term 
``timely filing'' (paragraph (a)) is used in (b)(1) as part of one of 
the conditions to be met for the managed care plan to continue the 
benefits; paragraph (b)(1) provides that the enrollee or the provider 
must ``file the appeal timely.'' The plain language in (b)(1) regarding 
the reference to ``timely,'' would impose a deadline on the enrollee's 
filing of the request for an appeal; however, the deadline described in 
Sec.  438.420(a) is inconsistent with the deadline for requesting an 
appeal established in Sec.  438.402(c)(2)(ii) (60 calendar days

[[Page 27637]]

from the date on the adverse benefit determination notice).
    We did not intend for Sec.  438.420(a) or (b) to truncate the 
period of time for the enrollee to request an appeal of the adverse 
benefit determination under Sec.  438.402(c)(2)(ii). To correct this 
error, we have modified Sec.  438.420(a) to replace ``timely'' with 
``timely files'' and specify that ``timely files'' means ``files for 
continuation of benefits on or before. . . .'' This revision will 
clarify that all requirements related to the availability and the 
duration of continuation of benefits are contained in Sec.  438.420.
    We are also finalizing a revision to the deadline in this 
definition. As proposed, the deadline was the later of: (1) 10 calendar 
days of the MCO, PIHP or PAHP mailing the notice of adverse benefit 
determination or (2) the intended effective date of the plan's adverse 
benefit determination. In the final rule, we will replace the term 
``mailing'' with ``sending'' to recognize that electronic communication 
methods, subject to Sec.  438.10, may be used. Taken together, the 
revisions to Sec.  438.420(a) mean that if the managed care plan did 
not meet its obligation to send the notice of the adverse benefit 
determination 10 calendar days before the termination or reduction of 
previously authorized services, the enrollee has longer than the 
original authorization period to timely file a request for continuation 
of benefits. To illustrate, the enrollee's original authorization 
period expires on the 30th day of the month and the managed care plan 
mails the notice of the adverse benefit determination on the 29th day 
of the month. The enrollee would have until the 9th day of the 
following month, which exceeds the period of the original authorization 
period, to timely file a request for continuation of benefits. Lastly, 
to recognize the use of electronic communication methods, the word 
``mailing'' has been replaced with ``sending.''
    In paragraph (b)(1), we will add text to the regulation to clarify 
that the enrollee must file the request for appeal timely by adding a 
cross-reference to Sec.  438.402(c)(ii) to incorporate the timeframe 
for the enrollee's or provider's request for an appeal. We are also 
finalizing slightly different text in Sec.  438.420(b)(1) regarding who 
files the appeal to be consistent with our finalization of Sec.  
438.404 (see section I.B.1.b). The continuation of benefits is 
intrinsically linked to the appeals process so we believe that any 
continuation of benefits pending appeal of a termination, suspension or 
reduction of previously authorized benefits must be conditioned on a 
timely request for an appeal. We acknowledge that an enrollee may 
request an appeal after the enrollee requests continuation of benefits 
due to the variation in timeframes; actual continuation of benefits is 
conditioned; however, on the filing of the appeal consistent with the 
timing requirements in Sec.  438.402. We encourage managed care plans 
to specify in their notice of the adverse benefit determination that 
both the appeal and request for continuation of benefits may be filed 
concurrently. Paragraphs (b)(2) and (b)(3) are being finalized 
substantively the same as proposed, with the replacement of the term 
``course of treatment'' with ``services'' in (b)(2); these paragraphs 
require that the appeal involve termination, suspension, or reduction 
of a previously authorized services ordered by an authorized provider.
    Paragraph (b)(4) proposed that, as another condition for an 
enrollee to receive continuation of benefits, the original period 
covered by the original authorization has not expired. We believe it is 
important to have this requirement as the enrollee must have been 
entitled under the previous authorization to receive the benefit to 
receive continuation of benefits. However, we will finalize this 
paragraph with on modification to delete the word ``original'' 
preceding ``period'' as that word is not necessary to convey the intent 
of the provision. Whether the first or a latter authorization is in 
effect is itself immaterial so long as an authorization for the 
services that is subject to the adverse benefit determination has not 
expired or lapsed at the time of the enrollee's timely filing of a 
request for continuation of benefits.
    Lastly, we modify paragraph (b)(5) to incorporate the ``timely 
files'' standard in paragraph (a) and replaced the word ``extension'' 
with ``continuation'' for consistent use of terms. We are finalizing 
paragraph (b)(5) with these modifications to make clear that the 
enrollee must request continuation of benefits in a timely manner.
    Comment: A few commenters suggested that enrollees should not have 
to request continuation of benefits because services should 
automatically be continued with the filing of an appeal or State fair 
hearing about the termination, suspension or reduction of a previously 
authorized service. We also received a few comments suggesting that 
providers should be added to proposed Sec.  438.420(b)(5) and, thereby, 
permitted to request continuation of benefits on the enrollee's behalf.
    Response: We do not agree that continuation of benefits should be 
automatic or that the provider should automatically be able to request 
continuation on the enrollees' behalf. Because an enrollee may be held 
liable for payment for those continued services, as specified in Sec.  
438.420(d), we believe it is critical that the enrollee--or an 
authorized representative of the enrollee who is not a provider--
initiate the request.
    Comment: We received several comments requesting that CMS clarify 
that managed care plans should not be required to continue benefits 
beyond state established quantitative limits.
    Response: We decline to revise the rule to address this situation. 
Managed care plans need to address this question to their state and the 
processes for handling such cases should be stipulated in the managed 
care plan's contract.
    Comment: Many commenters supported the removal of existing Sec.  
438.420(c)(4). A few commenters were opposed to the deletion because 
they believed it could allow the costs of the continued benefits to 
grow quickly and for an undetermined amount of time, which would not be 
in the enrollee's nor the managed care plan's best interest.
    Response: We appreciate the supportive comments and understand 
those in opposition to our proposed removal of existing Sec.  
438.420(c)(4). However, we believe that allowing enrollees to receive 
on-going services during an appeal or state fair hearing about the 
early termination or reduction of those services is an important 
protection for enrollees. Additionally, because the process includes 
the active participation of the enrollee (that is, the enrollee can 
elect the extent and duration of the services that they wish to 
continue receiving), the enrollee has some ability to control the 
amount of liability they are willing to assume. As such, we believe it 
is appropriate to finalize the amendment to Sec.  438.420 without the 
text that currently appears in paragraph (c)(4).
    Comment: We received many comments on proposed Sec.  438.420(d). 
Several commenters were opposed to enrollees being held liable for the 
cost of the services if the final decision was adverse to the enrollee. 
A few commenters suggested that proposed Sec.  438.420(d) include 
exemptions for enrollees unable to pay or if the enrollee received 
EPSDT services. One commenter suggested that enrollees only be held 
liable for those services continued during a state fair hearing.

[[Page 27638]]

    Response: We understand the commenters' opinions on this provision; 
however, this provision has been included in part 438 since it was 
finalized in 2002, as well as in part 431 since 1979. It is outside the 
scope of this rule to mandate exemptions for certain populations or 
limit its applicability to just services provided during the state fair 
hearing.
    Comment: We received several comments suggesting that states 
provide, or require the managed care plan to provide, manageable 
repayment plans. We received a few comments recommending that states be 
required to ensure that managed care plans do not take any punitive or 
negative actions against enrollees from whom they are attempting to 
recoup payment. One commenter believed states should monitor managed 
care plans to ensure that excessive or abusive recoupment practices are 
not utilized.
    Response: While we agree with commenters' concerns generally, we 
decline to include language in the regulation because we believe that 
the standards for the process of recoupment should remain with the 
states. We agree with commenters that manageable repayment plans are a 
reasonable way to implement this provision and encourage states and 
managed care plans to consider it. We also agree that states should 
have monitoring mechanisms in place to ensure that their managed care 
plans are not taking punitive or negative actions against enrollees nor 
engaging in excessive or abusive recoupment practices. Monitoring 
complaints received through the state's beneficiary support system, as 
well as grievance reports from the managed care plans would be one such 
mechanism.
    Comment: One commenter recommended that CMS set standards for 
recoupment activity by managed care plans as permitted in proposed 
Sec.  438.420(d).
    Response: The states have the option to determine whether to permit 
recoupment in their managed care programs if they also take recoupments 
under FFS; therefore, we believe developing the necessary policies and 
procedures should also remain with the states and decline to adopt 
regulation text as recommended by the commenter.
    Comment: We received some comments on the language ``Such practices 
must be consistently applied within the State under managed care and 
FFS delivery systems'' in proposed Sec.  438.420(d). Some commenters 
believed this sentence should be deleted while others requested 
clarification on the definition and scope of ``practices'' and 
``consistently.''
    Response: We agree that language could be clearer. In the final 
rule, we are combining ``consistent with state's usual policy on 
recoveries under Sec.  431.230(b)'' and ``as specified in the MCO's, 
PIHP's, or PAHP's contract'' and moving these phrases earlier in the 
first sentence to make the provision easier to understand. The last two 
sentences proposed in paragraph (d) are not being finalized since the 
first sentence now captures the substance of those sentences.
    Comment: A few commenters requested that CMS clarify that managed 
care plans permitted to pursue recoupment must only pursue recovery 
from the enrollee, not the provider. Some commenters believed it was 
inappropriate retract funds from the provider simply because it was 
easier.
    Response: As explained in the previous comment, Sec.  438.420(d) is 
being finalized to read that managed care plans may, if permitted in 
their contract with the state, pursue recovery ``consistent . . . with 
Sec.  431.230(b)'', and Sec.  431.230(b) clearly states ``. . . the 
agency may institute recovery procedures against the applicant or 
beneficiary to recoup the cost of any services furnished the 
beneficiary, to the extent they were furnished solely by reason of this 
section.'' We believe these provisions are sufficiently clear and 
decline to revise Sec.  438.420(d).
    Comment: We received a few comments stating that the costs of 
pursuing recoupment and the amount likely to actually be recouped 
should be taken into consideration during the rate setting process.
    Response: This is a reasonable adjustment for actuaries to consider 
during the rate setting process. As Sec.  438.5(f) establishes general 
standards for adjustment, we decline to explicitly reference the 
treatment of recoupments in the rate setting process.
    Comment: One commenter recommend that CMS create a new section in 
part 431 to require that that the state fair hearing be reviewed de 
novo to ensure the fairness of that process. The commenter believed 
that under Goldberg v. Kelly, 397 U.S. 254 (1970), a constitutionally 
impartial hearing will not occur until the individual reached the state 
fair hearing level of appeal. To ensure this fairness, the state fair 
hearing needs to occur de novo.
    Response: We decline to add a new section specifying the level of 
review for the state fair hearing as that is addressed in Sec.  
431.233. That section permits a beneficiary to request a de novo review 
but does not require that standard of review as a default. This is 
consistent with the holding of Goldberg v. Kelly, 397 U.S. 254 (1970).
    After consideration of the public comments, we are finalizing Sec.  
438.210 substantially as proposed with a few modifications. In 
paragraph (a)(2), we are including a cross-reference to the coverage 
standards in part 440 for beneficiaries under age 21. In Sec.  
438.210(a)(5)(i), we are finalizing as proposed except for the addition 
of quantitative and non-quantitative treatment limits. In Sec.  
438.210(a)(5)(ii), we are deleting the proposed text and redesignating 
paragraph (iii) as (ii); in Sec.  438.210(a)(5)(ii)(D), we are 
modifying to include the opportunity for enrollees receiving LTSS to 
achieve person-centered goals and live and work in the setting of their 
choice. In Sec.  438.210(b)(3), we are revising to use individual 
instead of health care professional since the definition of health care 
professional is not being finalized. In paragraph (c), we are 
finalizing the text with technical corrections. In Sec.  438.210(d)(3), 
we are finalizing text for the timing standard applicable to 
authorizations of covered outpatient drug authorizations as described 
in section 1927(d)(5)(A) of the Act.
    After consideration of public comments, we are finalizing Sec.  
438.420 substantially as proposed with several modifications. In Sec.  
438.420(a), we are correcting ``Definitions'' to ``Definition,'' using 
``timely files,'' and clarifying the definition; in Sec.  
438.420(a)(i), we are replacing the term ``mailing'' with ``sending'' 
to recognize the use of electronic communication methods. In Sec.  
438.420(b)(1), we are also finalizing slightly different text regarding 
who files the appeal, consistent with our finalization of Sec.  
438.404, to prohibit a provider from filing the request for 
continuation of benefits. In Sec.  438.420(b)(2), we are replacing 
``course of treatment'' with ``services.'' In Sec.  438.420(b)(4), we 
are not finalizing ``original'' before ``period'' for clarity. In Sec.  
438.420(b)(5), we are finalizing minor text revisions for clarity. We 
are also finalizing grammatical changes in (b)(1) through (4) to 
clarify that the all of the conditions must be met. In Sec.  
438.420(c)(1), we are adding a reference to state fair hearing for 
consistency with rest of section. In Sec.  438.420(d), we are 
finalizing more succinct wording for clarity and not finalizing 
specific policies about the content of the managed care plan contract.

[[Page 27639]]

e. Continued Services to Beneficiaries and Coordination and Continuity 
of Care (Sec. Sec.  438.62, 438.208)
    To ensure consistent continuity of care and coordination of 
services for beneficiaries, we proposed revisions to Sec. Sec.  438.62 
and 438.208.
    The existing regulatory framework for coordination of care focuses 
on three elements: (1) All enrollees must have an ongoing source of 
primary care; (2) a person or entity will coordinate the care provided 
by the MCO, PIHP, or PAHP; and (3) additional assessments and treatment 
plans are in place for individuals identified by the state as having 
special health care needs. In 2002, when the current regulations were 
finalized, the use of managed care for delivery of LTSS or providing 
medical services to more complex populations was not prevalent and, 
therefore, not substantially reflected in the regulations.
    The proposed changes sought to align the Medicaid managed care 
framework with other public and private programs and improve 
coordination and continuity of care. To that end, we proposed to: set 
standards for transition plans when a beneficiary moves into a new MCO, 
PIHP, or PAHP; expand beyond the emphasis on primary care when 
considering care coordination; strengthen the role of the assigned care 
coordinator; ensure more accurate and timely data gathering and 
sharing; and include enrollees with LTSS needs in the identification, 
assessment and service planning processes. The proposals were to modify 
sections Sec. Sec.  438.62 and 438.208.
(1) Transition Between Medicaid Delivery Systems (Sec.  438.62)
    Our only explicit transition of care standards included in current 
Medicaid managed care regulations (codified at Sec.  438.52) focus on 
when a beneficiary is mandated into a single MCO, PIHP or PAHP in a 
rural area. As stated in our preamble, we believed there should be 
transition of care standards for all Medicaid beneficiaries 
transitioning from one delivery system to another within Medicaid (even 
MCO to MCO), and not just rural area enrollees.
    We proposed no changes to paragraph (a) other than to add PCCM 
entity as discussed elsewhere in this rule. We proposed to add a 
standard to Sec.  438.62(b) which would require that states have a 
transition of care policy in place for individuals moving to managed 
care from FFS, or from one MCO, PIHP, PAHP, PCCM, or PCCM entity to 
another when an enrollee without continued services would experience 
serious detriment to their health or put them at risk of 
hospitalization or institutionalization. Under this proposal, states 
would define the transition policy, as long as it met the standards 
proposed in paragraph (b)(1), and would have the flexibility to 
identify the enrollees for which the MCOs, PIHPs, PAHPs, PCCMs, or PCCM 
entities would need to provide transition activities. Paragraph (b)(1) 
proposed that state transition policies include: Permitting the 
enrollee to continue to receive the services they are currently 
receiving from their current provider for a specified period of time in 
paragraph (b)(1)(i); referring the enrollee to an appropriate 
participating provider in paragraph (b)(1)(ii); assuring that the state 
or MCO, PIHP, or PAHP comply with requests for historical utilization 
data in paragraph (b)(1)(iii); and assuring that the enrollee's new 
provider is able to obtain appropriate medical records in paragraph 
(b)(1)(iv). References to ``services'' mean services covered under the 
contract, which would include prescription drugs if the managed care 
plan is obligated to provide such services under the contract. We also 
proposed, at paragraph (b)(1)(v), that additional procedures for the 
transition plan may be specified by the Secretary as necessary to 
ensure continued access to services for an enrollee to prevent serious 
detriment to the enrollee's health or to reduce the risk of 
hospitalization or institutionalization.
    In paragraph (b)(2), we proposed that states include a requirement 
for a transition of care policy meeting the standards in the regulation 
(and the state transition policy) in their MCO, PIHP, and PAHP 
contracts. We proposed to interpret the regulation text in a way to 
provide flexibility for states to decide whether to apply the state 
developed policy consistently to their MCOs, PIHPs, and PAHPs, or 
whether to permit the managed care plans to have different policies, as 
long as the state's minimum standards are met. We believed this 
approach would achieve an appropriate balance between assuring ongoing 
care for individuals who have significant needs while permitting states 
flexibility to determine how best to implement these transitions. At a 
minimum, the proposed regulation would also require the transition 
policies to be included in the state's comprehensive quality strategy, 
be publicly available, and included in information provided to 
potential enrollees.
    We received the following comments in response to our proposal to 
revise Sec.  438.62.
    Comment: We received many comments in support of our proposed 
expansion of Sec.  438.62. Commenters believed the additional detail in 
this section is needed and will ensure that enrollees will have better 
access to continued services during time of transition.
    Response: We thank the commenters for their support of the 
additional detail. While we will be making some revisions in the final 
rule, we have retained the proposed structure and much of the proposed 
text of Sec.  438.62.
    Comment: We received a few comments that recommended CMS remove 
much of the proposed text to be less prescriptive in the final rule. 
These commenters believed that the states were in the best position to 
design their transition of care policies and procedures.
    Response: We believe some level of specificity in this section is 
necessary to establish minimal requirements across all states to 
protect beneficiaries as they transition across health care options. We 
believe the requirements strike a balance between assuring minimal 
protections for enrollees and consistency and state flexibility.
    Comment: We received many comments for additional situations that 
would trigger the use of the transition of care policy proposed in 
Sec.  438.62(b). In addition to the proposed situations of enrollees 
transitioning from FFS to managed care and between managed care plans, 
commenters suggested adding transitions from managed care to FFS, from 
(or to) the Marketplace or private insurance; from (or to) Medicare; 
when an enrollee's provider leaves the network; upon release from 
incarceration, and when significant changes are made to the delivery 
system. Commenters believed that enrollees would benefit from 
transition planning when any of these occurred.
    Response: We agree that many of these suggestions present good 
transition situations for states and managed care plans to consider 
including in their policies; however, we decline to include them in the 
final rule in part due to limits on the scope of this rule and concerns 
about the practicality of the suggested requirements. For most of these 
suggestions, the requirement for transition planning would be one 
sided. Part 438 cannot impose requirements on the Marketplace QHPs, 
private insurance, or Medicare. These other, non-Medicaid entities 
would be under no obligation to cooperate or provide information to the 
Medicaid program or managed care plans within Medicaid. We encourage 
states and plans to attempt transition planning in the

[[Page 27640]]

suggested situations but do not believe it would be appropriate to 
mandate it in Sec.  438.62(b).
    When significant delivery system changes are being made, we believe 
that states and managed care plans are already performing transition 
planning. Since states are required to notify and sometimes obtain 
approval from CMS for significant delivery system changes, we receive 
information on their transition planning efforts and have the 
opportunity to review and provide feedback. Providers leaving a network 
may warrant providing transition services for enrollees; however, these 
situations frequently do not. Therefore, we leave the decision of 
determining when a network change warrants transition services to the 
state.
    Comment: One commenter suggested that states and managed care plans 
obtain stakeholder input when developing their transition policies to 
ensure that they are comprehensive and represent all populations and 
their needs.
    Response: We agree that stakeholders may provide valuable input 
into the development of states' and managed care plans' transition 
policies and encourage states and managed care plans to utilize 
stakeholder input as appropriate. We decline, however, to require the 
inclusion of stakeholder input in the final rule.
    Comment: We received some comments on proposed Sec.  438.62(b) 
requiring transition of care policies to ensure continued access to 
services, specifically suggestions for additions to the language ``when 
an enrollee, in the absence of continued services, would suffer serious 
detriment to their health or be at risk of hospitalization or 
institutionalization.'' Some commenters recommended adding the 
following triggers for requiring transition of care: when an enrollee 
is completing a course of treatment; has a scheduled procedure within 
60 days of the transition; is receiving care for a terminal illness; is 
receiving pregnancy or post-partum care; or the state determines that 
other circumstances warrant continued access. A few commenters 
recommended deleting the language altogether as they believed it was 
too limiting because transition planning could prevent gaps in 
treatment or ensure that an enrollee has appropriate access to time-
sensitive services in other situations.
    Response: We appreciate the comments on this provision but conclude 
that most of the suggested additions are adequately captured in the 
proposed standard for when the regulation requires continued access to 
services. Additionally, the standard in Sec.  438.62(b), as proposed 
and as finalized, is a minimum; states and Medicaid managed care plans 
have latitude to add to their policies as they deem appropriate. As to 
specifying no criteria at all in Sec.  438.62(b), we do not believe 
that is prudent. While we agree that there may be additional enrollees 
that may benefit from transition planning, we believe it is best to set 
minimum standards and permit states and managed care plans to expand 
from that minimum. This approach gives states and plans flexibility to 
customize their policies to meet the needs of their program and covered 
populations. Therefore, we will be finalizing this provision as 
proposed.
    Comment: A few commenters recommend that CMS specify in proposed 
Sec.  438.62(b)(1)(i) that ``providers'' includes providers such as 
pharmacies, transportation, and ancillary services.
    Response: The use of the term ``providers'' in Sec.  
438.62(b)(1)(i), as proposed and finalized, is intended to be as broad 
as possible and allow the inclusion of any necessary provider types. As 
such, we decline to add specific provider types to this provision.
    Comment: We received many comments on ``period of time'' as used in 
proposed Sec.  438.62(b)(1)(i) relating to continued access to services 
from current providers. Some commenters believed CMS should define the 
length of the period for continued services while others recommended 
specific lengths of time ranging from 30 days to one year. A few 
commenters recommended requiring the length of the period for enrollees 
in a nursing or assisted living facility be indefinite. Some commenters 
recommended including the duration of the enrollee's course of 
treatment or scheduled procedure including any necessary follow-up 
appointments, or--in the case of a pregnant or post- partum enrollee--
until 60 days post-partum, or--in the case of an enrollee with a 
terminal illness--for the duration of the illness, or--in the case that 
the state identifies other circumstances that warrant continued 
access--for a period of time identified by the state, if that provider 
is not in the MCO, PIHP or PAHP network. A few commenters recommended 
that transition plans for enrollees receiving LTSS should continue 
until the enrollee's service plan is due for re-evaluation or the 
enrollee's condition changes. Some commenters believed that defining 
the length of the period of time should not be left to state 
discretion. One commenter suggested that plans be required to notify 
enrollees before the end of the transition period to confirm 
understanding.
    Response: We urge states and managed care plans to ensure that the 
period of time for continued access (to a provider who is no longer in-
network) is appropriate for the circumstances of the applicable 
enrollee when developing transition plans under this regulation. 
However, given the variation in the amount of time needed to safely 
transition an enrollee under different circumstances, specifying a time 
frame in Sec.  438.62(b)(1)(i) would not be the best approach. We agree 
that a reminder notification to the enrollee may be helpful in some 
circumstances and encourage states and plans to consider this option.
    Comment: A few commenters recommended that Sec.  438.62(b)(1)(i) be 
revised to include access to all services and providers the enrollee 
had access to previously while a few commenters recommended that access 
to services and providers should be limited to only those that, without 
transition accommodations, would actually cause serious detriment to 
the enrollee's health or place the enrollee at risk of hospitalization 
or institutionalization.
    Response: We understand the commenters' concerns and clarify that 
paragraph (b)(1)(i) should be read as a complete sentence so that 
``current provider'' is associated with the access to services. It was 
not our intent to imply that providing an enrollee time to make a 
transition was the same as allowing the enrollee unfettered access to 
their previous network of providers. To the comment on limiting 
transition services to only those enrollees that, without transition 
accommodations, would actually suffer serious detriment to their health 
or place the enrollee at risk of hospitalization or 
institutionalization, we note that the regulation text sets that as the 
minimum standard in paragraph (b) generally by identifying the 
enrollees for whom the transition of care policy must apply. The 
regulation sets a minimum requirement and states and plans have the 
flexibility to include additional enrollees and/or qualifying criteria.
    Comment: We received a few comments on the sharing of data in 
proposed Sec.  438.62(b)(1)(iii) and the difficulties inherent in this 
provision. Commenters believe issues around confidentiality, 
particularly given regulations at 42 CFR part 2, Confidentiality of 
Alcohol and Drug Abuse Patient Records, make compliance with this 
provision difficult. Several commenters recommended that CMS confer 
with the Office of the

[[Page 27641]]

National Coordinator for Health IT (ONC) on ensuring consistency with 
their work on interoperability standards. Another commenter recommended 
CMS encourage the adoption of standards such as requiring the use of 
standardized transport, message and content formats for required 
reporting, and aligning expectations for these standards as specified 
in the ONC Interoperability Standards Advisory.
    Response: We acknowledge the challenges around data sharing and 
note that the proposal, and the final rule at Sec.  438.62(b)(1)(iii), 
require that the sharing of information be in compliance with Federal 
and State law. We support the work of ONC and endorse the use of ONC's 
Roadmap and the 2015 Interoperability Standards Advisory in achieving 
compliant data sharing while meeting the goals of these provisions. We 
do not believe that this final rule is the appropriate forum for 
changes to other regulatory frameworks for protecting patient data and 
privacy.
    Comment: A few commenters suggested that CMS remove proposed Sec.  
438.62(b)(1)(v) that reads ``Any other necessary procedures as 
specified by the Secretary to ensure continued access to services to 
prevent serious detriment to the enrollee's health or reduce the risk 
of hospitalization or institutionalization.'' The commenters believed 
any criteria should be specified in the rule and, if additional 
provisions are added later, they should be added through a process that 
permits public comment.
    Response: We understand the commenters' concerns but find it 
prudent to finalize the proposed text to provide the ability to reflect 
industry or practice changes and best practices that may warrant 
specific inclusion at a later time; we believe that the standard 
reflected in the regulation (necessary to ``ensure continued access to 
service to prevent serious detriment to the enrollee's health or reduce 
the risk of hospitalization or institutionalization'') effectively 
limits the scope of any additional procedures identified by the 
Secretary at a later date. Only by applying this standard and making 
the affirmative determination that additional procedures are necessary 
for this purpose may the Secretary (through CMS) adopt additional 
procedures for the transition of care policies. Further, the regulation 
does not prohibit us from using rulemaking or soliciting public comment 
in identifying such additional procedures.
    After consideration of the public comments, we are finalizing Sec.  
483.62 as proposed with two modifications. In paragraph (a), we are 
adding a comma between ``PCCM'' and ``or.'' In paragraph (b)(3), we are 
finalizing the regulation text without the word ``comprehensive'' 
modifying the term ``quality strategy'' to be more consistent with how 
this final rule generally refers to the quality strategy required under 
Sec.  438.340.
(2) Applicability of Care Coordination (Sec.  438.208(a))
    The current regulation at Sec.  438.208(a) requires the State to 
ensure through its contracts, that each MCO, PIHP, and PAHP meet 
specific coordination and continuity of care standards outlined in 
paragraphs (b) and (c), with two exceptions. We proposed technical 
changes to the exceptions for MCOs, PIHPs, and PAHPs serving dually 
eligible individuals. We proposed no changes to paragraph (a)(1). We 
proposed to delete paragraph (a)(2)(i) as it is redundant to language 
proposed in paragraph (b)(1); however, doing this necessitates 
incorporating the existing provisions in paragraph (a)(2)(ii) into 
(a)(2). We proposed minor technical corrections in Sec.  
438.208(a)(3)(i) to replace the outdated reference to ``Medicare+Choice 
plan'' with ``MA organization.'' Additionally, in Sec.  
438.208(a)(3)(ii), we proposed that the decision to grant an exception 
to a MCO serving dually eligible individuals would be based on the 
needs of the population served rather than on what services are covered 
under the contract.
    We received the following comments in response to our proposal to 
revise Sec.  438.208(a).
    Comment: We received one comment on proposed Sec.  438.208(a)(2) 
regarding the exception permitted for PIHPs and PAHPs from the 
treatment plan requirements proposed in Sec.  438.208(c)(3). The 
commenter believed that this provision should be narrowed to only allow 
exceptions in appropriate and limited circumstances.
    Response: The proposed text in Sec.  438.208(a)(2) limits the 
exceptions a state may grant for identifying, assessing, and producing 
a treatment plan for an individual with special health needs. We 
believe the language, based on the scope of the entity's services, and 
on the way the State has organized the delivery of managed care 
services, provides sufficient parameters for state decision making 
while still affording latitude to account for the characteristics of 
the variety in state programs.
    Comment: We received a few comments requesting clarification of 
proposed Sec.  438.208(a)(3)(ii) regarding the exception for MCOs that 
serve dually eligible enrollees. The commenters believed this provision 
as proposed was overly broad and unclear. Another commenter questioned 
whether this provision would allow a state to permit an MCO covering 
LTSS to assign a primary care provider to the enrollee while acute 
medical care was covered by Medicare as the primary payer.
    Response: We proposed the change in Sec.  438.208(a)(3)(ii) because 
the provisions in Sec.  438.208(c) are by their nature, driven by the 
needs of the population. The need for an assessment and treatment/
service plan should be determined by the needs of the enrollees, not by 
how covered services are defined in a contract. In regard to the 
question whether the state would permit an MCO covering LTSS to assign 
a primary care provider to the dually eligible enrollee when acute 
medical care was covered by Medicare, the exception proposed in Sec.  
438.208(a)(3)(ii) only addresses exceptions relative to the provisions 
proposed in Sec.  438.208(c) (which are applicable to enrollees who 
require LTSS or have special health care needs). The commenter should 
consult with their state for clarification regarding primary care 
provider assignment in that circumstance.
    After consideration of the public comments, we are finalizing Sec.  
438.208(a) as proposed, with a modification to include a cross-
reference to the definition of ``Medicare Advantage Organization'' in 
Sec.  422.2.
(3) Care Coordination Activities (Sec.  438.208(b))
    As noted in the preamble to the proposed rule, the Agency for 
Healthcare Research and Quality (AHRQ) defines care coordination as 
``deliberately organizing patient care activities and sharing 
information among all of the participants concerned with a patient's 
care to achieve safer and more effective care. This means that the 
patient's needs and preferences are known ahead of time and 
communicated at the right time to the right people, and that this 
information is used to provide safe, appropriate, and effective care to 
the patient.'' \9\ Although we believe most MCOs, PIHPs, and PAHPs are 
already doing these activities, we proposed to update our regulations 
to align with the governing policies of the MA program and the 
Marketplaces. We also proposed several modifications to Sec.  
438.208(b) and (b)(1): (1) To revise the language in paragraph (b)(1) 
from services ``furnished to'' enrollees, to services ``accessed by''

[[Page 27642]]

enrollees, to more adequately describe the entire range of services 
covered by the regulations; (2) to remove references to ``primary'' to 
ensure each enrollee receives access to an ongoing source of care 
appropriate to their needs, regardless of whether the service provider 
is considered a primary care provider; and (3) to remove the words 
``health care'' to explicitly recognize that MCOs, PIHPs, and PAHPs may 
coordinate not only health care services but a full range of community 
based support services to provide services in the most integrated 
setting to enrollees.
---------------------------------------------------------------------------

    \9\ AHRQ Web site: http://www.ahrq.gov/professionals/prevention-chronic-care/improve/coordination/index.html.
---------------------------------------------------------------------------

    We proposed to expand the standards in paragraph (b)(2) so that 
care coordination activities by MCOs, PIHPs, and PAHPs involve 
coordination between care settings in paragraph (b)(2)(i) and 
coordination with services provided outside of the MCO, PIHP or PAHP, 
including with another MCO, PIHP, or PAHP in paragraph (b)(2)(ii) and 
FFS Medicaid in paragraph (b)(2)(iii).
    We also noted in the preamble that we believe that managed care 
plans must ensure that appropriate information is available to, shared 
with, and maintained by all providers and the MCO, PIHP, or PAHP that 
is coordinating the care. Therefore, we proposed, under our authority 
at section 1902(a)(4) of the Act, to add standards in new paragraphs 
(b)(3) and (b)(5) that each MCO, PIHP and PAHP make their best effort 
to complete an initial health risk assessment within 90 days of the 
effective date of enrollment for all new enrollees and that all 
providers maintain and share an enrollee health record according to 
MCO, PIHP, or PAHP standards. We also proposed to remove the phrase 
``with special health care needs'' from existing paragraph (b)(3) 
(proposed to be redesignated at (b)(4)) and change the word ``its'' to 
``any'' in that same paragraph to broaden the standard for sharing 
assessment results to avoid duplication of services. The standard of an 
initial health assessment is explicit in the MA regulations in Sec.  
422.112(b)(4)(i), so we believed these changes established consistent 
standards for MCOs participating in Medicare and Medicaid, thereby 
easing administrative burden. Finally, in the redesignated paragraph 
(b)(4) regarding the sharing of the results of an enrollee's need 
assessment with another MCO, PIHP, or PAHP that serves the enrollee, we 
proposed to add the state as a recipient of that information if the 
state (through FFS) provides coverage of some services to an enrollee, 
such as behavioral health or pharmacy coverage. In addition, we 
proposed that existing paragraph (b)(4) be moved without change to 
paragraph (b)(6).
    We received the following comments in response to our proposal to 
revise Sec.  438.208(b).
    Comment: We received many comments expressing strong support for 
the proposed revisions in this section. Commenters believed our 
proposed revisions better reflect the reality of the current managed 
care environment by acknowledging LTSS and removing the previous focus 
on medical needs and services. Commenters were particularly supportive 
of the expanded detail proposed for coordination requirements in Sec.  
438.208(b)(2) and health risk assessments in Sec.  438.208(b)(3).
    Response: We thank the commenters for their support and agree that 
the revisions to Sec.  438.208(b), as proposed and finalized, will 
provide stronger protections and improve the care experience for 
managed care enrollees across the spectrum of services that may be 
covered under the contract.
    Comment: We received a few comments recommending that CMS remove 
its proposed revisions to Sec.  438.208 and leave coordination and 
continuity to the states' discretion. Another commenter stated that the 
proposed provisions should be less prescriptive to permit greater state 
flexibility.
    Response: Given the changes in Medicaid managed care programs since 
42 CFR part 438 was finalized in 2002 and the more complex populations 
being enrolled, additional specificity in this section is appropriate. 
We attempted to strike the appropriate balance and believe Sec.  
438.208(b), as proposed and finalized here, still leaves ample 
flexibility to the states.
    Comment: We received a few comments on proposed Sec.  438.208(b). 
Commenters recommended that state and managed care plan coordination 
policies be made publicly available along with instructions for how 
enrollees may request coordination services. A few other commenters 
recommended that states and managed care plans ensure that their 
subcontractors are also aware of their coordination policies and how to 
access coordination services for an enrollee. A few commenters 
suggested that the states should act as a repository for data needed 
for coordination activities since they have both FFS data and encounter 
data.
    Response: We appreciate the commenters' recommendation and states 
are welcome to make their coordination policies publicly available if 
they so choose. We agree that states and managed care plans should 
educate their enrollees and all subcontractors on the process and the 
contact information for accessing care coordination. This is especially 
important for providers since they may recognize the need for 
coordination more quickly than the enrollee. Maintaining a central 
repository of data is an innovative idea but is likely not feasible in 
most states without a significant investment of time and resources. We 
encourage states and plans to collaborate on the feasibility and 
usefulness of such a database or other tools to facilitate data needs 
related to care coordination.
    Comment: We received comments supporting proposed Sec.  
438.208(b)(1) that would require each enrollee receiving care 
coordination to have a designated person or entity responsible for 
their care coordination. A few commenters suggested that enrollees be 
notified of the name and contact information for their designated 
person or entity.
    Response: We agree that enrollees who are assigned a care 
coordinator should know how to contact the coordinator for questions or 
issues about their coordination plan. Managed care plans must implement 
procedures to ensure that this information is provided to enrollees in 
a timely manner; therefore, we will revise Sec.  438.208(b)(1) to 
reflect this requirement.
    Comment: We received many comments on proposed Sec.  438.208(b)(2). 
One commenter recommended that if care coordination is not provided or 
not provided in a person-centered way, the enrollee should be able to 
request an appeal.
    Response: If an enrollee has a concern about the delivery of 
coordination of care, they should contact their managed care plan and 
file a grievance. Doing so will not only bring resolution for that 
enrollee but provide valuable information to the managed care plan 
alerting it to possible systemic issues. Issues about the quality of 
care coordination would not be eligible to be appealed as quality 
issues do not meet the definition of adverse benefit determination. 
Coordination of care is not itself a separate covered service but a 
means of how services are assessed and furnished to enrollees.
    Comment: We received many comments in response to our request for 
comment on including an additional standard relating to community or 
social support services in paragraph Sec.  438.208(b)(2). The commenter 
suggested that this provision could include linking enrollees to 
services through organizations such as Protection and Advocacy 
organizations, Legal Aid, Aging and Disability Resources Centers, 
Centers for

[[Page 27643]]

Independent Living, Area Agencies on Aging, or United Way 311 lines. We 
received overwhelming support for the proposal to add the additional 
standard.
    Response: We thank the commenters for their support of this 
proposal. We will finalize an additional provision at Sec.  
438.208(b)(2)(iv) that includes services the enrollee receives from 
community and social support providers.
    Comment: Some commenters recommended that behavioral health, 
substance use disorder, pharmacy, durable medical equipment, and all 
ancillary services be specifically identified in proposed Sec.  
438.208(b)(2). Commenters believed these types of services are 
frequently overlooked by managed care plans in their care coordination 
efforts.
    Response: We decline to modify the regulation text as recommended 
here. As proposed and finalized in this rule, Sec.  438.208(b)(2)(i) 
through (iv) addresses services received by the enrollee in all 
settings of care and from, another MCO, PIHP, PAHP, or FFS Medicaid, or 
community and social support providers. These categories are 
sufficiently broad to capture all of the specific services suggested by 
commenters.
    Comment: We received some comments recommending that Sec.  
438.208(b)(2) include specific situations when care coordination may be 
beneficial. Commenters' recommendations included transitions from 
managed care to FFS, from or to the Marketplace or private insurance; 
from or to Medicare; when an enrollee's provider leaves the network; 
upon release from incarceration, and when significant changes are made 
to the delivery system. Commenters stated that they believe managed 
care plans often miss these types of opportunities to provide care 
coordination.
    Response: We appreciate the commenters' recommendations and 
encourage managed care plans to consider them in the development and 
implementation of their care coordination policies. However, we decline 
to revise the regulation text to explicitly refer to these situations.
    Comment: One commenter recommended that Sec.  438.208(b)(2) include 
an exemption for managed care plans that attempt care coordination but 
cannot complete it due to a needed health or medical record that is not 
available or provided by the holding entity.
    Response: We understand the commenter's concern but believe the 
inability to obtain a record is a common occurrence and managed care 
plans should train staff on appropriate steps to take to address it. We 
decline to revise Sec.  438.208(b)(2) to provide such an exemption.
    Comment: We received many comments on the initial health risk 
assessment of enrollee needs proposed in Sec.  438.208(b)(3). The most 
common comment was that use of ``assessment'' in this paragraph seemed 
inconsistent with the way the term was used in Sec.  438.208(c)(2). 
Commenters suggested that requirement in Sec.  438.208(b)(3) be called 
a ``health risk screening'' to avoid confusion. The commenters believed 
that term more accurately reflected CMS' intention. A few commenters 
appeared to interpret this provision as requiring a visit with a 
primary care provider. We also received a few comments that states 
should act as a repository for all of the data collected and forward 
the data to the appropriate managed care plan(s) upon enrollment. 
Commenters believed having the state be responsible for sharing the 
data among plans would make the process much easier and consistent 
given that all contracted managed care plans already have data sharing 
agreements and interfaces established with the state.
    Response: We thank the commenters for their suggestions and agree 
that proposed Sec.  438.208(b)(3) was unclear given our use of 
``assessment'' in Sec.  438.208(c)(2). We agree that ``screening'' 
better describes our intended meaning and have made this change in the 
final rule. We take this opportunity to clarify that our intent in 
Sec.  438.208(b)(3) was for the managed care plan to administer a 
survey type instrument to gather health needs related information from 
each enrollee, not to have enrollees receive a PCP visit within the 
initial 90 days.
    We appreciate the suggestion that the state act as a repository for 
all of the data collected and assume responsibility for facilitating 
sharing of the data but decline to include that in the final rule. 
States are not prohibited from taking that approach but we do not 
believe it should be a requirement. We are finalizing Sec.  
438.208(b)(3) to reflect ``screening,'' as well as rearranging some of 
the text for better grammatical flow.
    Comment: A few commenters recommended that CMS design the tool to 
be used in Sec.  438.208(b)(3) to facilitate consistency. One commenter 
requested clarification as to whether this task could be contracted to 
an outside entity. One commenter recommended that CMS establish 
measureable goals to assess the completion rate within the required 
time frame. One commenter recommended that the assessment proposed in 
Sec.  438.208(b)(3) be required to be completed through a home visit.
    Response: We understand the commenter's concern about consistency 
but decline to produce the tool to be used in Sec.  438.208(b)(3). We 
believe states should have flexibility for this given the differences 
in program design, covered populations, and benefits. In response to 
the question of subcontracting this function to another entity, we 
clarify that there is no prohibition on delegating this task but remind 
managed care plans that any subcontracting agreement must meet the 
requirements of Sec.  438.230, including adequate provisions for 
protected and timely data sharing. While we agree that establishing 
completion goals and measuring against them is an effective monitoring 
tool, we decline to set such standards. The states are better 
positioned to develop and implement such criteria. Home visits are an 
option available to managed care plans, or their designee, but we leave 
this approach as an option for states and decline to include it as a 
requirement.
    Comment: Many commenters sought clarification on our use of ``best 
effort'' in proposed Sec.  438.208(b)(3) for completion of the health 
risk screening. Some commenters believed it was too vague and that 
managed care plans should be required to complete the assessment. A few 
commenters recommended that CMS define ``best effort'' by specifying 
the number and type of attempts that must be made by the plan. One 
commenter suggested removing ``including subsequent attempts.'' A few 
commenters suggested that enrollees be required to cooperate in 
completing these assessments while other commenters believed that 
states need to provide more accurate contact information for enrollees.
    Response: We understand the commenters' concerns about the 
flexibility in the proposed ``best effort'' standard and the challenges 
inherent in contacting enrollees. However, it is the challenges in 
contacting enrollees and obtaining their cooperation to complete the 
screening that makes the flexibility of a ``best effort'' standard 
necessary. We believe that managed care plans and states understand the 
value of the information obtained during these early screenings and 
will make appropriate efforts to complete them. We do not believe 
mandating specific number and/or type of attempts would make the 
requirement more productive, given the wide range of issues that 
managed care plans encounter when trying to complete the screening. We 
also acknowledge that maintaining accurate contact information has its 
challenges, but are hopeful that the flexibility provided elsewhere in 
this final rule for

[[Page 27644]]

the use of electronic communication and to subcontract the health risk 
screening will reduce these issues. We understand that completing an 
initial health risk screening is not without its challenges and, 
therefore, believe that the flexibility permitted in the provision 
strikes an appropriate balance.
    Comment: We received some comments on the 90 day time frame for 
completion of the health risk screening proposed in Sec.  
438.208(b)(3). Commenters offered suggestions ranging from 30 days to 
120 days while some recommended an exemption for times when there are 
large influxes of enrollees in a short period of time. Some commenters 
recommended that enrollees be prioritized based on known risks with 
those screenings done sooner. Others recommended that screenings only 
be completed on known high-risk enrollees while others suggested that 
screenings not be required for enrollees that would be getting an 
assessment under the provisions proposed in Sec.  438.208(b).
    Response: While we understand commenters' statements that having 
the information from the screening sooner will benefit the enrollee and 
managed care plan, we believe the requirement must include a reasonable 
time frame for completing the screenings. As discussed in the response 
to other comments, there are challenges to completing these screenings. 
Given these challenges, we believe that it may not be feasible for a 
managed care plan to complete the process in 30 days. Similarly, we 
believe that extending the time frame could erode the benefits 
completing the screening and acting on the information. We believe 90 
days is an appropriate timeframe and strikes a balance between these 
competing concerns. We understand that when there is a large influx of 
enrollees at once or in a short period of time, even 90 days may not be 
sufficient. We believe that ``best effort'' provides flexibility for 
unusual circumstances and encourage managed care plans to continue 
outreach to new enrollees to attempt completion even if the 90 day 
period has ended.
    For the commenters that suggested prioritizing enrollees and 
excluding those being assessed under Sec.  438.208(c), we are unclear 
on what information the managed care plan would use to determine that a 
new enrollee is high risk or would be eligible for the assessment in 
Sec.  438.208(c). Managed care plans may be able to identify some of 
these types of enrollees (perhaps through eligibility codes), but it 
does not appear that the information necessary to accurately determine 
high risk enrollees or those in need of LTSS or with special health 
care needs would be consistently or reliably available at the time of 
enrollment. We do not believe it is appropriate to completely exclude 
enrollees from the health risk screening simply based on their 
eligibility for an assessment in Sec.  438.208(c). While we are not 
expressly prohibiting prioritization for the health risk screening, we 
urge plans to be careful in its application and to ensure that 
resources are appropriately utilized to attempt screening completion 
for all enrollees within the specified timeframe.
    Comment: A few commenters requested that CMS clarify that a plan's 
inability to reach an enrollee to complete the health risk screening or 
the enrollee's refusal to participate in the health risk screening 
cannot be used as grounds for disenrollment or reduced benefits. 
Another commenter recommended that managed care plans use community 
resources when they are having difficulty contacting an enrollee as 
these resources often have other information or in person resources 
available. The commenter believes this is particularly useful for 
homeless enrollees or those with behavioral health or substance use 
disorders.
    Response: We understand the commenters' concern and take this 
opportunity to remind states and managed care plans that the inability 
to reach an enrollee to complete the screening or if the enrollee will 
not participate in the screening cannot be used as grounds for 
disenrollment, reduced benefits, or any other negative or punitive 
action by the state or managed care plan. Disenrollments requested by 
the managed care plan are regulated at Sec.  438.56, finalized 
elsewhere in this rule. We agree with the commenter's suggestion to use 
community resources, when appropriate, to assist with hard to reach 
enrollees. We encourage plans to consider whether utilizing community 
resources would be helpful as drawing on such resources would support 
the ``best effort'' standard set forth Sec.  438.208(b)(3).
    Comment: We received a few comments recommending that all screening 
tools used to comply with proposed Sec.  438.208(b)(3) contain elements 
addressing social determinants of health. The commenters believed these 
elements can provide valuable information that would provide the 
managed care plan with a more comprehensive and accurate profile of the 
enrollee's needs.
    Response: We encourage managed care plans to include elements 
addressing social determinants of health in their health risk screening 
tool as they deem appropriate but decline to specify that such elements 
must be included as part of the health risk screening to satisfy 
federal requirements.
    Comment: We received some comments on proposed Sec.  438.208(b)(5) 
regarding the sharing of health records. One commenter asked CMS to 
clarify the meaning of ``health record.'' Several commenters requested 
that CMS specifically identify which providers and how much of the 
health record was intended in this proposed provision. One commenter 
recommended that providers be required to share health records with the 
state and managed care plan. Lastly, a few commenters expressed concern 
that compliance with this provision is hampered by stringent 
confidentiality laws and the number of providers that do not utilize 
electronic health records.
    Response: We proposed the term ``health record'' as opposed to 
``medical record'' to recognize the inclusion of services not 
traditionally considered medical in nature, such as LTSS. Although we 
are not defining the term, in general, a health record is any 
information that relates to the past, present, or future physical 
health, mental health or condition of an individual or the past, 
present, or future provision of services to an individual. As to 
specifically defining which providers and the quantity of information 
to share, we believe managed care plans have extensive experience in 
this area and are capable of using their judgment and clinical 
expertise to determine how much and with whom they share all or part of 
the health record. While we understand the challenges of obtaining 
health records, placing requirements directly on service providers is 
outside the scope of this rule. For providers in FFS or managed care 
networks, access to health records should be addressed in the 
provider's agreement. Lastly, we understand that the use of electronic 
health records is not consistent across the health care industry. 
Managed care plans will have to use whatever methods they find 
necessary to successfully and securely exchange information with 
providers. We also acknowledge the complex laws and regulations on 
privacy and data sharing and the impact they have on compliance with 
requirements to share enrollee information. We expect states and 
managed care plans to comply with all applicable laws and regulations.
    After consideration of the public comments we are finalizing 
paragraph (b) of Sec.  438.208 with modifications. In

[[Page 27645]]

Sec.  438.208(b)(1), we are finalizing new text to require that 
enrollees be provided the contact information for their care 
coordinator; in Sec.  438.208(b)(2)(iv), we are adding text to require 
coordination with community and social support providers; and in Sec.  
438.208(b)(3), we are changing ``assessment'' to ``screening'' and 
revising the sentence for better grammatical flow. We will also 
finalize punctuation and grammatical changes to the various 
subparagraphs in paragraph (b) to preserve readability and clarity.
(4) Long-Term Services and Supports (Sec.  438.208(c))
    As we stated in the preamble to the proposed rule, the current 
Medicaid managed care regulations were written at a time when a managed 
care delivery system was not frequently utilized for LTSS. With states 
using managed care to deliver covered services to populations with more 
complex needs, care coordination that is appropriate for individuals 
using LTSS becomes an important component of managed care.
    We proposed changes in paragraph (c)(1) of Sec.  438.208 to add 
enrollees who need LTSS to the populations for which the state must 
have mechanisms to identify these enrollees to the MCO, PIHP, or PAHP. 
We proposed a change to paragraph (c)(1)(i) to reflect that the 
mechanisms required in paragraph (c)(1) must be included in the state's 
comprehensive quality strategy as defined in proposed Sec.  438.340. We 
also proposed that states may use their staff, their enrollment 
brokers, and the MCOs, PIHPs, and PAHPs as part of these identification 
mechanisms. There were no changes proposed to paragraph (c)(1)(ii). 
Other changes we proposed to paragraph (c) included:
     Amending paragraph (c)(2) so that assessments for both 
individuals in need of LTSS as well as those with special health care 
needs are comprehensive and are conducted by appropriate providers or 
LTSS service coordinators having qualifications specified by the state 
or the MCO, PIHP, or PAHP. We believe this to be a critical standard to 
avoid insufficient service or treatment plans or a disruption in 
services to enrollees.
     Amending paragraph (c)(3) to clarify that treatment plans 
would also be considered service plans and that they are developed for 
individuals needing LTSS in addition to individuals with special health 
care needs.
     Amending paragraph (c)(3)(i) to propose that treatment or 
service plans are developed by an individual meeting the managed care 
plan or state's service coordination provider standards in consultation 
with other providers caring for the enrollee. This change was intended 
to permit a MCO, PIHP, or PAHP to use internal staff for service 
coordination, even though those staff would not be considered providers 
and, thus, not permitted to perform assessments under current 
regulation.
     Adding new standards under paragraphs (c)(3)(ii) to 
require that treatment or service plans developed for those in need of 
LTSS conform with the person centered planning standards found in Sec.  
441.301(c)(1) and (2). This proposal is consistent with the HCBS final 
rule released in 2014 (CMS-2249 and CMS-2296).
     Redesignating current paragraphs (c)(3)(ii) and (iii) 
without change as paragraphs (c)(3)(iii) and (iv). Proposed a new 
standard under paragraph (c)(3)(v) that service and treatment plans be 
reviewed and revised upon reassessment of the enrollee's functional 
needs, at least every 12 months, when the enrollee's circumstances or 
needs change significantly, or at the request of the enrollee.
    No changes were proposed for paragraph (c)(4).
    We received the following comments in response to our proposal to 
revise Sec.  438.208(c).
    Comment: We received several comments supporting proposed Sec.  
438.208(c)(1) requiring states to identify enrollees who need LTSS or 
have special health care needs. Many commenters suggested that CMS 
should use greater specificity in the definition of person with special 
health care needs, including adding a provision to specify that special 
health care needs includes children, children with SED, and adults with 
SMI or SUD. One commenter stated that, in identifying those with 
special health care needs, some enrollees may not have higher costs, 
but merely need more care coordination.
    Response: We thank the commenters for their support of the 
provision requiring states to identify enrollees who need LTSS or 
special health care needs. We believe there is merit in leaving the 
definition of special health care needs in proposed Sec.  438.208(c)(1) 
to the discretion of the states and decline to modify the regulation to 
specify the scope of special health care needs. There is no universal 
definition of special health care needs, and attempting to define it in 
the regulation could result in the inadvertent exclusion of some 
populations that a state may consider as having special health care 
needs. We believe that leaving special health care needs undefined 
allows states to tailor their systems to reflect the particular needs 
of their populations and increase the likelihood of covering the 
largest number of people who need the additional protections that the 
provisions in this section offer.
    Comment: One commenter expressed concern about the identification 
of enrollees with special health care needs after enrollment, and 
stated that the regulation should specify the actor responsible for 
identifying these enrollees.
    Response: We agree with the commenter that the identification of 
enrollees with special health care needs should not just occur at the 
point of enrollment. Although the state's identification would occur at 
the time of enrollment, Sec.  438.208(c)(1)(ii) allows for the state to 
subcontract the identification of individuals with special health care 
needs to the managed care plans. The regulation at Sec.  438.208(c)(1) 
does not specify that the identification of enrollees with special 
health care needs should only occur at the time of enrollment and we 
expects that states and managed care plans will have ongoing mechanisms 
to identify these individuals as their needs change throughout their 
period of eligibility. We decline to modify Sec.  438.208(c)(1).
    Comment: One commenter recommended that CMS remove 
``comprehensively assess each Medicaid enrollee . . . as needing LTSS . 
. .'' in Sec.  438.208(c)(2) and limit the requirement to assessing 
just the need for LTSS. The commenter believed states should be 
permitted to define the type and frequency of care coordination for 
their MLTSS enrollees since care coordination standards vary among 
states. However, a number of other commenters stated that there should 
be greater specificity from CMS. Several commenters recommended that 
CMS should develop a uniform assessment tool, along with guidelines and 
processes to be used across all states. These commenters clarified that 
a uniform tool would facilitate the collection of high quality data, as 
well as improve service delivery. Several other commenters stated that 
CMS should require that such standardized assessment tools be developed 
with input from community-based LTSS providers.
    Response: We believe that the requirement in the regulation to 
comprehensively assess enrollees who need LTSS is an essential 
protection, and should not be revised or narrowed. We recognize that 
care coordination protocols vary because of the diversity in the 
design, benefits, and populations covered in Medicaid and LTSS

[[Page 27646]]

programs. However, we believe that a comprehensive assessment is 
appropriate and that the enrollee, providers and managed care plan 
benefit when an individual's total care needs are known and 
coordinated. We decline to remove or revise ``comprehensively'' in 
Sec.  438.208(c)(2).
    We supports states' efforts in the development of standardized 
assessment instruments and processes; however, we decline to require a 
uniform assessment tool or establish criteria for such a tool in this 
regulation.
    Comment: Several commenters provided specific recommendations for 
the content of the assessments in proposed Sec.  438.208(c)(2). Several 
commenters believed that the assessment should include both medical and 
non-medical/functional needs as well as the need for housing, while 
another commenter stated that the assessment should include the need 
for occupational therapy. Several commenters recommended that the 
assessment should address the needs of children aging out of the 
pediatric medical system into the adult system to assist families in 
managing their child's ongoing health needs. Another commenter stated 
that the assessment should be comprehensive enough to capture both 
physical and behavioral health needs, as well as the needs of those 
with cognitive disabilities. A commenter suggested that the assessment 
only apply to enrollees in need of LTSS.
    Response: We appreciate the suggestions on the content of the 
assessment but decline to specify such content in the final rule. We 
believe the word ``comprehensively'' in proposed Sec.  438.208(c)(2) is 
sufficient to describe our expectations for states and managed care 
plans regarding the content of such assessments. We do not agree with 
commenters who requested that the requirement (which exists in current 
Sec.  438.208(c)(2) for special health care needs enrollees) only apply 
to enrollees in need of LTSS. The purpose of the assessment is to 
determine the appropriate course of treatment or regular care 
monitoring for enrollees with special health care needs, as defined by 
the state, and for enrollees in need of LTSS. A comprehensive 
assessment could include criteria such as physical health, behavioral 
health, and non-medical needs, the needs of those transitioning between 
provider specialties (for example, pediatric to adult medicine), and 
ancillary services. While these may be relevant criteria for 
consideration, the scope of the assessment should reflect the state's 
definition of enrollees with special health care needs and the nature 
of the enrolled population that require LTSS.
    Comment: Some commenters suggested that the assessment should 
address caregiver needs along with their capacity to do so and their 
need for training prior to delivering care. Several commenters noted 
that this would be consistent with language at Sec.  441.720(a)(4) that 
provides ``if unpaid caregivers are required to implement any elements 
of the person-centered service plan, a caregiver assessment (must be 
conducted)''.
    Response: We agree that ascertaining caregiver capacity before 
including their services in a treatment or service plan is important to 
ensure that the enrollee's needs can be met; however we believe that 
requiring a caregiver assessment is outside the scope of this 
regulation and inconsistent with the principle of allowing states 
utilizing managed care to develop their own assessment standards.
    Comment: We received a number of comments on proposed Sec.  
438.208(c)(2) regarding the use of appropriate health care 
professionals or individuals meeting LTSS service coordination 
requirements set by the state or the managed care plan to conduct the 
assessment. Some commenters supported the provision as written; 
however, a number of commenters stated that having the MCO, PIHP or 
PAHP or their employees conduct the assessment represented a conflict 
of interest, and recommended that proposed Sec.  438.208(c)(2) be 
revised to reflect that the assessment should be independent of the 
managed care plan and not conducted by managed care plan staff. A 
commenter noted that assessments often are used by managed care plans 
as a tool to limit services or establish enrollee budgets. Further, 
several commenters noted that the assessment should be fully `conflict-
free', and that the person conducting the assessment be neither a 
managed care plan employee nor a provider of services. Finally, one 
commenter referenced language in CMS 2013 MLTSS Guidance that 
prohibited managed care plan involvement in functional assessments used 
for eligibility determinations, and asked CMS to clarify how that was 
different from the assessment in proposed Sec.  438.208(c)(2).
    Response: We do not agree that MCOs, PIHPs, and PAHPs should be 
prohibited from conducting assessments on their own enrollees. In fact, 
such assessments are a critical component of care management systems 
that managed care plans rely on to monitor the health needs and 
outcomes of their enrollees. States have the flexibility to contract 
with an independent assessment entity but such arrangements are not 
required under this regulation. Additionally, while we agree that 
assessments are often used by managed care plans to establish the 
medical necessity for services, the same is true of home and community 
based providers in FFS, where assessments often determine the need for 
services as well as the budget.
    We appreciate the opportunity to clarify how the assessment 
referenced in the 2013 MLTSS Guidance is different than the assessment 
proposed in Sec.  428.208(c)(2). The 2013 MLTSS Guidance prohibited 
managed care plan involvement in functional assessments conducted prior 
to enrollment for the purpose of determining initial eligibility for 
services. The assessments in Sec.  428.208(c)(2) are conducted by 
managed care plans after enrollment and are assessments of their own 
enrollees. We do not perceive the same conflict of interest in having 
MCOs, PIHPs and PAHPs assess individuals already enrolled in their 
plans to determine the appropriate care to be provided by the plan.
    Comment: Several commenters stated that CMS should require that 
those who conduct assessments have specific training and extensive 
experience with LTSS, and that they include specific professionals, 
such as registered nurses, social workers, behavioral health 
counselors, community health workers, and other similarly credentialed 
professionals. One commenter suggested that CMS modify the language in 
Sec.  428.208(c)(2) to clarify that a state can use an enrollment 
broker for both the identification and assessment functions.
    Response: We do not believe additional specificity regarding the 
credentials of persons that can conduct assessments is warranted since 
it is the responsibility of the state to develop the standards. 
However, we restate that Sec.  438.208(c)(2) requires that the 
assessment process use appropriate provider or individuals meeting LTSS 
service coordination requirements. We are also correcting the 
regulation text at Sec.  438.208(c)(2) to use ``provider'' in place of 
the proposed use of ``health care professional'' for reasons discussed 
in section I.B.9.a. of this final rule.
    Comment: One commenter expressed concern for the cost of conducting 
assessments and stated that rates should consider the cost of training 
assessors to properly administer an assessment tool.
    Response: We agree that the cost of conducting assessments and 
training assessors is a legitimate administrative cost for the non-
benefit component of

[[Page 27647]]

the capitation rate for plans with these responsibilities.
    Comment: Several commenters recommended that systems be in place to 
protect those who are assessed incorrectly and are in danger of losing 
services. A few commenters stated that CMS should create adequate 
appeal mechanisms that apply to the assessment process.
    Response: We believe that adequate safeguards already exist at 42 
CFR part 438, subpart F for appeals where the assessment results in a 
reduction or denial of services, or a grievance when the enrollee 
believes that the assessment does not adequately reflect functional 
need. Therefore, we believe that no change in Sec.  428.208 is 
necessary.
    Comment: The regulation at Sec.  438.208(c)(3) requires MCOs, PIHPs 
and PAHPs to develop treatment or service plans, if the state requires 
it, for enrollees who require LTSS or those with special health care 
needs who are determined through the assessment to need a course of 
treatment or regular care monitoring. A number of commenters stated 
that this requirement should be mandatory, not optional. Other 
commenters believed that it should be mandatory for all MCOs, PIHPs and 
PAHPs, not based on whether the state requires it only for those who 
require LTSS. Another commenter stated that limiting the scope to only 
those identified by the state potentially excludes those with complex 
care needs.
    Response: We agree with commenters that treatment or service plans 
are critical for those needing LTSS and may be appropriate for 
individuals with special health care needs. Requiring treatment or 
service plans for individuals needing LTSS is also consistent with the 
preamble discussion at 80 FR 31143. Therefore, we are finalizing Sec.  
438.208(c)(3) to reflect that treatment or service plans are required 
for enrollees using LTSS but at the state's discretion for individuals 
with special health care needs. We are also adding text to clarify that 
treatment/service plans for enrollees using LTSS must meet paragraphs 
(b)(i) through (v), while treatment/service plans for enrollees with 
special health care needs must meet paragraphs (b)(iii) through (v).
    Comment: Several commenters stated that the use of the terms 
`treatment' and `service' plans in proposed Sec.  438.208(c)(3) was 
confusing. One stated that the term `service plan' or `care plan' 
should be used exclusively instead. Another stated that the word 
`treatment' applied to the overall health of the individual and the 
term `care plan' made more sense.
    Response: In using both terms in proposed Sec.  438.208(c)(3), we 
intended to incorporate the terminology most widely used for 
individuals needing LTSS or those with special health care needs. In 
reality, there may be other terms in use as well, particularly in 
programs that focus on specific populations. To list them all in the 
regulation would be not be feasible or appropriate. Further, while some 
treatment/service plans are clearly related to `treatment', for example 
for those with complex or rare medical conditions, in other cases or 
for some populations the word `care' or `treatment' is objectionable, 
as it implies a medical model that may not be applicable for those 
needing long term support to live independently. For that reason, we 
believe it is appropriate to use both terms, and decline to revise 
Sec.  438.208(c)(3) as recommended by the commenter.
    Comment: We received a number of comments stating that the MCO, 
PIHP or PAHP should not develop the treatment or service plan proposed 
in Sec.  438.208(c)(3)(i), as that would present a conflict of 
interest. Several commenters recommended adding the word `independent' 
to the text describing the individual developing the treatment or 
service plan. We also received a comment stating that Sec.  
438.208(c)(3)(i) should not provide that the treatment/service plan be 
developed by the enrollee's provider as that does not comply with Sec.  
441.301(c)(1)(vi).
    Response: The language in Sec.  438.208(c)(3)(i) is intended to 
address a wide variety of situations for individuals with needs ranging 
from medical conditions that require additional monitoring to those 
with extensive support needs, such as LTSS. We believe that managed 
care plans appreciate the importance of complete and thorough 
treatment/service plans and states have sufficient experience to ensure 
that appropriate levels of oversight and review are in place to 
evaluate compliance with the requirements in Sec.  438.208(c)(3)(i). 
Therefore, we decline to require that the treatment or service plan be 
developed independently of the MCO, PIHP or PAHP.
    We agree with the last comment that, as drafted, the reference to 
the enrollee's provider in proposed Sec.  438.208(c)(3)(i) was 
inconsistent with the regulation governing home and community based 
services generally in Sec.  441.301. To correct this, we are finalizing 
paragraph (c)(3)(i) without the text ``the enrollee's provider;'' we 
rely on the reference to Sec.  441.301(c)(1) in Sec.  438.208(c)(3)(ii) 
to address a provider's level of involvement. As a conforming change, 
we are finalizing (c)(3)(i) without ``other'' in the phrase ``in 
consultation with any. . . .''
    Comment: Some commenters stated that the individual and his or her 
caregiver should be able to choose who develops the treatment or 
service plan, including the individual him/herself.
    Response: Section Sec.  438.208(c)(3) provides that the MCO, PIHP, 
or PAHP produce a treatment or service plan. Paragraph (c)(3)(ii) 
provides that the process for developing the treatment or service plan 
is conducted in a person-centered manner consistent with Sec.  
441.301(c)(1) and (2), which requires that the person-centered planning 
process will be led by the individual where possible. We do not believe 
that modification to the regulatory text is necessary.
    Comment: One commenter recommended that the person conducting the 
treatment or service plan should be licensed and credentialed; another 
recommended that the person should have expertise in the enrollee's 
special condition, and several stated that it is critical that someone 
who is involved in caring for the individual is also involved in the 
development of the treatment or service plan. One commenter suggested 
that the person creating the treatment or service plan should have 
training in the person-centered planning process. Another commenter 
asked if existing MCO, PIHP or PAHP staff would be grandfathered in and 
asked CMS to clarify who was responsible to pay the costs to train them 
in person-centered planning and if it was a Medicaid reimbursable cost.
    Response: Regarding the credentials of those developing the 
treatment or service plans, Sec.  438.208(c)(3)(ii) provides that it be 
developed by a person trained in person-centered planning using a 
person-centered process as defined in Sec.  441.301(c)(1) and (2). We 
believe it is unnecessary to provide greater specificity in Sec.  
438.208(c)(3)(ii) about the credentials or training of the person 
developing the treatment or service plan. Training staff on the person-
centered planning process is a legitimate administrative cost for the 
non-benefit component of the capitation rate for plans with these 
responsibilities.
    Comment: We received a few comments regarding person centered 
planning requirements. One commenter thought the requirement would 
limit the ability of managed care plans to conduct utilization 
management. Another

[[Page 27648]]

commenter thought service providers should do the person-centered 
planning, and not the managed care plans. Finally a commenter thought 
the regulation should specify a requirement for person-centered care.
    Response: We believe that person-centered planning is the 
foundation of effective long term services and supports. Because LTSS 
support an individual to engage in their daily life activities, the 
enrollee should be the leader in identifying key goals and desired 
outcomes of the service plan. This does not mean that an enrollee 
automatically is, or should be, approved for every requested service 
and support; rather, that the enrollee's goals are the basis for the 
types of services and supports approved. The managed care plans must 
apply the criteria set forth by the state for approval or denial of 
services as noted in Sec.  438.208(c)(3)(iv). Service planning 
functions rest with the enrollee and the managed care plan, or other 
entity the state designates as is outlined in Sec.  438.208 and must be 
implemented consistent with in Sec.  441.301(c)(1-2).
    Comment: The regulation at Sec.  438.208(c)(3)(ii) requires that 
treatment or service plans are developed using the process and plan as 
defined in Sec.  441.301(c)(1) and (2) for LTSS treatment or service 
plans. Several commenters supported this proposed provision, but others 
believed that greater clarity was needed to reinforce that the process 
to be used by a managed care plan must be consistent with Sec.  
441.301(c)(1) and (2). Another commenter stated that the reference was 
unnecessary and suggested that it be deleted.
    Response: We believe it is important that states use the process 
and plan in Sec.  441.301(c)(1) and (2) for LTSS because the service 
and treatment plans developed under Sec.  438.208 should also be 
consistent with standards for a person-centered process. The provisions 
in Sec.  441.301(c)(1) and (2) include important details about the 
process and plan that help to ensure thorough and consistent results. 
We do not believe it is necessary to add additional detail in Sec.  
438.208(c)(3)(ii).
    Comment: We received a number of comments regarding the content of 
the treatment or service plan and the various processes and protocols 
related to it. One commenter suggested that treatment or service plans 
should be developed from the health risk assessments that are required 
under Sec.  438.208(b)(3) of this regulation. Another commenter stated 
that the treatment or service plan should include documentation of 
referrals to other providers, and evidence that such referrals were 
effective. One commenter suggested that the requirements of the 2013 
MLTSS guidance should be incorporated in this regulation. Several 
commenters mentioned the importance of addressing transitions in the 
treatment or service plan, including for those transitioning from 
pediatric to adult health care, and those with behavioral health needs. 
A few commenters stated that the treatment or service plan should 
describe how LTSS is coordinated with other community services and 
physical and behavioral health services. One commenter suggested that 
the enrollee should approve the treatment or service plan. Finally, a 
commenter suggested that protocols for care coordination be made 
publicly available and specified in the MCO, PIHP or PAHP contract.
    Response: We do not agree that the treatment/service plan required 
by Sec.  438.208(c)(3) should be developed from the health risk 
assessment proposed in Sec.  438.208(b)(3). As explained elsewhere in 
these responses, the health risk assessment is not expected to collect 
or be based on the same level of detail as the assessment in Sec.  
438.208(c)(2), and therefore, would be inappropriate as the sole source 
of information for the development of a treatment/service plan. We 
believe that the standards in Sec.  441.301(c)(1) and (2) are 
sufficient to address referrals, transitions, and coordination with 
other services and are consistent with the 2013 MLTSS guidance. In 
regard to the comment about the enrollee approving the treatment or 
service plan, Sec.  441.301(c)(2)(ix), which is incorporated by 
reference in Sec.  438.208(c), specifies that the individual provides 
written informed consent to the treatment or services plan. We believe 
that no revisions are needed inSec.  438.208(b)(3).
    Comment: One commenter recommended that states and MCOs, PIHPs and 
PAHPs be required, in the planning process, to address the needs of 
family caregivers. In particular, they stated that family caregivers 
should not be included in the treatment or service plan if they have 
not agreed to provide services; that a family caregiver assessment 
should be conducted consistent with the section 1915(i) language and 
that the family caregiver should be directed to supports to help reduce 
caregiver burden.
    Response: We agree that family caregivers are usually a critical 
component of LTSS, and that, if they are part of the service plan, the 
caregiver must be capable of, and willing to, provide the services just 
as any provider of services. We agree the needs and abilities of the 
informal network of caregivers supporting individuals are an important 
component of the treatment or service plan and encourage states to give 
these issues appropriate consideration. However, we believe this is 
outside the scope of part 438 and that no revisions are needed to Sec.  
438.208(c).
    Comment: We received many supportive comments for proposed Sec.  
438.208(c)(3)(v) which requires that treatment or service plans be 
reviewed and revised upon reassessment of functional need, at least 
every 12 months, or when the enrollee's circumstances or needs change 
significantly, or at the request of the enrollee per Sec.  
441.301(c)(3). We received one comment suggesting this provision only 
require treatment/service plans to be updated instead every 3 years, 
since that was less burdensome to providers and plans and more 
appropriate for enrollees.
    Response: We believe that the standards in proposed Sec.  
438.208(c)(3)(v) are necessary to ensure that the needs of enrollees 
with special health care needs or needing LTSS are addressed in a 
timely manner, and are modified when the enrollee's needs change. We 
disagree with the 3-year time frame because that period is too long to 
it would not keep the plan useful and meaningful. We decline to make 
changes to Sec.  438.208(c)(3)(v).
    Comment: One commenter stated that all providers under contract 
with the managed care plan should be required to follow the treatment 
or service plan.
    Response: It is the responsibility of the MCO, PIHP or PAHP to 
ensure that its contracted providers are providing care to enrollees in 
a manner consistent with the enrollee's treatment or service plan, as 
well as with all applicable standards and protocols of the managed care 
plan. We believe managed care plans understand this responsibility and 
do not believe modification to Sec.  438.208(c)(3) is necessary.
    Comment: Several commenters supported proposed Sec.  438.208(c)(4) 
regarding direct access to specialists. One commenter recommended 
requiring managed care plans to use standing referrals, and stated that 
a strong care planning system should result in standing referrals for 
those who need them.
    Response: We thank the commenters for their support and will retain 
the language in Sec.  438.208(c)(4) as proposed with one minor 
revision. Standing referrals are one approach to ensure direct access 
to specialists but we decline to specify the exact process for how a 
managed care plan should meet

[[Page 27649]]

its obligations under Sec.  438.208(c)(4). We are finalizing the 
regulation text at Sec.  438.208(c)(4) to use ``network provider'' in 
place of the proposed use of ``health care professional'' for reasons 
discussed in section I.B.9.a. of this final rule.
    After consideration of the public comments, in Sec.  438.208(c)(2) 
and (c)(3)(i), we are finalizing a change to ``provider'' in place of 
the proposed use of ``health care professional'' for reasons discussed 
in section I.B.9.a. of this final rule; in Sec.  438.208(c)(3), we are 
finalizing the provision to clarify the populations for which 
treatment/service plans are required and added ``;'' and ``and'' as 
appropriate between (3)(i) through (v); in Sec.  438.208(c)(3)(i), we 
are removing ``enrollee's provider;'' and ``other; ''and in Sec.  
438.208(c)(4), we revised ``health care professional'' to ``network 
provider'' for accuracy of intent.
f. Advancing Health Information Exchange
    As explained in the preamble to the proposed rule, health 
information technology (health IT) and the electronic exchange of 
health information are important tools for achieving the care 
coordination objectives proposed in Sec.  438.62, Sec.  438.208, and 
other parts of this final rule. The Department supports the principle 
that all individuals, their families, their healthcare and social 
service providers, and payers should have consistent and timely access 
to health information in a standardized format that can be securely 
exchanged among the patient, providers, and others involved in the 
individual's care (HHS August 2013 Statement, ``Principles and 
Strategies for Accelerating Health Information Exchange.'') Further, 
the Department is committed to accelerating health information exchange 
(HIE) through the use of health IT across the broader care continuum 
and across payers. Health IT that facilitates the secure, efficient and 
effective sharing and use of health-related information when and where 
it is needed is an important contributor to improving health outcomes, 
improving health care quality and lowering health care costs. Health IT 
can help health care providers recommend treatments that are better 
tailored to an individual's preferences, genetics, and concurrent 
treatments. In addition, it can help individuals make better treatment 
decisions and health-impacting decisions outside of the care delivery 
system.
    On October 6, 2015, the Office of the National Coordinator for 
Health Information Technology (ONC) published the final ``Connecting 
Health and Care for the Nation: A Shared Nationwide Interoperability 
Roadmap'' (available at https://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-version-1.0.pdf). This final 
roadmap focuses on how interoperable health IT can enable better health 
and wellness for all Americans, regardless of where they live, learn, 
work and play.
    In addition, ONC released the final version of the ``2016 
Interoperability Standards Advisory'' (available at https://www.healthit.gov/standards-advisory/2016). This final 2016 
Interoperability Standards Advisory is focused on clinical health IT 
interoperability and is published at https://www.healthit.gov/sites/default/files/2016-interoperability-standards-advisory-final-508.pdf. 
Updates to the final 2016 advisory's substance and structure reflect 
input obtained from the public at large throughout 2015 and the HIT 
Standards Committee. This final document contains a list of the best 
available standards and implementation specifications to enable 
priority HIE functions. Providers, payers, and vendors are encouraged 
to take these ``best available standards'' into account as they 
implement interoperable HIE across the continuum of care, including 
care settings such as behavioral health, long-term and post-acute care, 
and community service providers (for example, home and community-based 
service providers).
    In the proposed rule, we encouraged states, MCOs, PIHPs, PAHPs, 
PCCMs, PCCM entities, and other stakeholders to utilize HIE and 
certified health IT to effectively and efficiently help providers 
improve internal care delivery practices, support management of care 
across the continuum, enable the reporting of electronically specified 
clinical quality measures (eCQMs), and improve efficiencies and reduce 
unnecessary costs. We welcomed comment on how we might reinforce 
standards through future rulemaking or guidance to states and plans as 
standards become more mature and adoption of certified health IT 
increases.
    We received the following comments in response to this discussion.
    Comment: Many commenters supported the preamble discussion in the 
proposed rule at 80 FR 31141 regarding health information exchange. A 
few commenters recommended that CMS broaden the HITECH Act to include 
additional provider types to facilitate greater health information 
exchange. A few commenters also recommended that CMS modify the 
electronic health record (EHR) Incentive Programs.
    Response: We do not have the statutory authority to broaden the 
HITECH Act to include additional incentives for provider types nor do 
we have the statutory authority to modify the EHR Incentive Programs.
    Comment: Many commenters recommended that CMS include HIE adoption 
standards and requirements within states' managed care contracts. One 
commenter recommended that CMS require states' managed care contracts 
to leverage ONC certification. Several commenters recommended that CMS 
permit a 90/10 federal match for HIE activities within states' managed 
care contracts. Several commenters recommended that CMS allow 
expenditures for EHRs and HIE activities within states' managed care 
contracts. One commenter recommended that CMS require states to develop 
plans within their managed care contracts to address connectivity to 
the broader health information system, especially for LTSS providers.
    Response: Consistent with our discussion in the proposed rule at 80 
FR 31124 and regarding Sec.  438.6(c)(1)(ii), states have the 
flexibility to require managed care plan participation in broad-ranging 
delivery system reform or performance improvement initiatives, such as 
broad-based provider health information exchange projects. Broad-based 
provider HIE projects were provided only as an example; we do not 
believe it is appropriate for us to require or mandate this option, as 
states may have various options or paths to increase EHR and HIE 
adoption outside of their managed care contracts. If a state 
incorporated such a project in the managed care contract, the regular 
federal match applied to actuarially sound capitation payments would 
apply. Finally, any delivery system or provider payment initiative 
pursued under the managed care contract would be subject to a federal 
review and approval process as specified in Sec.  438.6(c)(2).
    Comment: Several commenters recommended that CMS consider sub-
regulatory guidance after the final rule is published to address health 
information exchange. A few commenters recommended that CMS release 
guidance to encourage a uniform national standard for all HIE 
activities, including uniform standards for all state and public health 
agencies. A few commenters recommended that CMS convene a stakeholder 
group to inform states and future HIE development activities. A few 
commenters recommended that CMS and ONC partner to provide state 
resources, tools, and guidance to assist providers in

[[Page 27650]]

better understanding the technical requirements for certified EHR 
technology (CEHRT). One commenter recommended that CMS release guidance 
that is consistent with ONC's Interoperability Roadmap and the draft 
Interoperability Standards Advisory. Finally, one commenter recommended 
that CMS release guidance on the use of clinical decision support (CDS) 
and appropriate use criteria (AUC) to assist states and providers 
achieve health IT goals and improve quality.
    Response: We appreciate commenters' concerns and recommendations 
regarding additional CMS guidance related to HIE. As discussed in the 
preamble of the proposed rule at 80 FR 31141, we believe that health 
information technology and the electronic exchange of health 
information are important tools for achieving improved population 
health. We agree with commenters that CMS, the Department, and ONC 
should continue to convene stakeholders, partner together, and support 
and release guidance consistent with the Interoperability Roadmap and 
ONC's annual Interoperability Standards Advisories.
    As this section of the preamble provided a discussion of ONC's 
Interoperability Roadmap and Interoperability Standards Advisory and 
did not result in regulation, there is no regulatory section to 
finalize in this rule.
g. Managed Long-Term Services and Supports (Sec. Sec.  438.2, 438.3, 
438.70, 438.71, 438.214, 438.330, 438.816)
    Managed long term services and supports (MLTSS) refers to an 
arrangement between state Medicaid programs and MCOs, PIHPs or PAHPs 
through which the MCO, PIHP, or PAHP receives a capitated payment for 
providing long-term services and supports (LTSS). MLTSS programs have 
grown significantly over the past decade and are expected to increase 
even more in the coming years. Recognizing this significant shift in 
delivery system design, we developed ten key principles inherent in a 
strong MLTSS program. These principles were released on May 21, 2013, 
in guidance \10\ for states using a section 1915(b) waiver or section 
1115(a) demonstration to implement a MLTSS program. We proposed in this 
rule to revise the Medicaid managed care regulations to ensure that all 
MLTSS programs, regardless of underlying authority, operate in 
accordance with these elements. Our proposal for amendments throughout 
part 438 incorporated and reflected these elements; proposals and 
regulations specific to MLTSS were discussed in the proposed rule in 
section I.B.5. Some of the changes we proposed--while prompted by MLTSS 
considerations--applied broadly to all beneficiaries, and so have been 
applied to all managed care programs.
---------------------------------------------------------------------------

    \10\ http://www.medicaid.gov/medicaid-chip-program-information/by-topics/delivery-systems/downloads/1115-and-1915b-mltss-guidance.pdf.
---------------------------------------------------------------------------

(1) Defining Long-Term Services and Supports
    We proposed to add a definition of Long-term services and supports 
(LTSS) to Sec.  438.2 for purposes of applying the rules in part 438 of 
this chapter; however, the definition will not be applicable to any 
other part of title 42 of the CFR. Our proposal defined LTSS as 
``services and supports provided to beneficiaries of all ages who have 
functional limitations and/or chronic illnesses that have the primary 
purpose of supporting the ability of the beneficiary to live or work in 
the setting of their choice, which may include the individual's home, a 
provider-owned or controlled residential setting, a nursing facility, 
or other institutional setting.'' We intended for community based 
services within the scope of this definition to be largely non-medical 
in nature and focused on functionally supporting people living in the 
community. Examples of what we would consider community based LTSS 
include Home- and Community-Based Services (HCBS) delivered through a 
section 1915(c) waiver, section 1915(i), or section 1915(k) state plan 
amendments, as well as personal care services otherwise authorized 
under the state plan. We note that individuals with chronic illness 
that may receive LTSS include individuals with mental health conditions 
and substance use disorders.
    We noted that we considered defining LTSS in a way that references 
specific services in title 42 such as HCBS and Nursing Facility 
services (defined in part 440), but determined that would be too 
limiting and not allow for future innovation in what services are 
considered LTSS. We requested comment on the proposed definition and 
whether it is appropriate in scope.
    We received the following comments in response to our proposal to 
add a definition of long-term services and supports to Sec.  438.2.
    Comment: Several commenters believed the definition for LTSS as 
proposed in Sec.  438.2 was satisfactory. However, the majority of 
commenters wrote that one or more of the definitional elements should 
be modified. One writer stated that there should be no definition given 
at all. A number of commenters suggested that the definition as 
proposed is too broad and would thus obligate states to broaden their 
LTSS coverage. A couple of commenters said that the definition should 
be based on a nursing facility level of care, while another suggested 
limiting the definition to requirements under section 1902(a) of the 
Act.
    Response: We clarify that the definition in this section is not 
intended to describe minimum service requirements for LTSS in states; 
rather, it defines the scope of supports and settings that would be 
covered by the regulatory requirements for managed LTSS programs. 
Managed care enrollees who have a functional limitation or chronic 
illness and receive any service that falls within the LTSS definition 
will be expected to have available a beneficiary support system and the 
other protections defined in this regulation for people using managed 
LTSS. The actual LTSS available to a beneficiary continues to be 
defined by the state in applications to CMS and the contracts with 
managed care plans. Because most states have LTSS programs that have 
less stringent and/or different criteria than nursing facility level of 
care and include a more expansive scope than section 1902(a) services, 
we believe such modifications to the definition to limit it based on 
those parameters would be too restrictive.
    Comment: Many commenters suggested additions or alternatives to the 
definition of the beneficiary who may be considered to be eligible for 
LTSS. Most suggested additions to the text ``has a functional 
limitation and/or chronic illness'' as proposed in Sec.  438.2. Several 
commenters recommended the addition of ``and family or informal 
caregivers'', several suggested ``or cognitive impairments'' be added, 
a few suggested adding ``people with disabilities'', one commenter 
suggested ``physical and behavioral disabilities'', and a few 
commenters suggested that people with ``social determinant challenges'' 
be added. Additionally, one commenter suggested that ``chronic 
illness'' be changed to ``chronic condition'' to more accurately 
reflect disabilities such as brain injuries that have multiple 
components.
    Response: We thank commenters for so many thoughtful suggestions 
for the definition of LTSS. We note that the definition of LTSS does 
not establish eligibility criteria for enrollees to receive LTSS; those 
eligibility criteria are established in the state plan and related 
state documents, including the

[[Page 27651]]

contracts with the managed care plan that furnishes or covers LTSS. The 
reference in the definition of LTSS is to establish the scope of the 
benefits and services that are LTSS.
    Further, in the International Classification of Functioning, 
Disability and Health (2001), the World Health Organization defines 
functional limitation as any health problem that prevents a person from 
completing a range of tasks, whether simple or complex, see http://www.cdc.gov/ncbddd/disabilityandhealth/types.html. Functional 
impairment encompasses any type of disability--physical, cognitive, 
intellectual or behavioral--as is intended in the LTSS definition. We 
agree that family and caregivers are often inextricably linked to the 
beneficiaries, but services and supports provided for caregivers are, 
from the perspective of the Medicaid agency or managed care entity, on 
behalf of the individual with the functional limitation or chronic 
illness. Social determinant challenges, while likely to exacerbate the 
effects of functional limitations or chronic illness, are common 
amongst Medicaid beneficiaries, not just those using LTSS. As to the 
comment to change ``chronic illnesses'' to chronic conditions,'' we 
believe that, in combination with functional impairments, chronic 
illnesses is more common terminology that may be more descriptive of 
the health care considerations inherent in a LTSS model. After much 
careful consideration, we have decided to retain the reference to 
people receiving MLTSS in the definition of LTSS as beneficiaries of 
all ages who have functional limitations and/or chronic illnesses.
    Comment: Several commenters recommended that CMS change the 
definition to include how LTSS should be planned and delivered. 
Specifically, a few commented that CMS should add person-centered 
planning in the definition, and a few others suggested that the 
definition should specify the preference by individuals for home and 
community-based services. One commenter stated that CMS prohibit states 
from limiting congregate settings in the definition. Additionally 
several commenters requested that the definition specify that 
individuals must participate in the community to the fullest extent 
possible. One commenter wanted CMS to add ``as appropriate'' to 
institutional placement.
    Response: Person-centered planning is addressed in Sec.  
438.208(c)(3)(ii) of the proposed and final rule; this final rule 
requires the MCO, PIHP, or PAHP to follow the person-centered planning 
process found in home and community-based regulations at Sec.  
441.301(c)(1) and (2). The home and community-based services (HCBS) 
page on Medicaid.gov provides detailed information on what this person-
centered requirement entails, see http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Long-Term-Services-and-Supports/Home-and-Community-Based-Services/Home-and-Community-Based-Services.html.
    Section 438.3(o), as proposed and finalized, also requires the HCBS 
regulation at Sec.  441.301(c)(4) to be followed for all HCBS settings 
where the services could be in a sections 1915(c), 1915(i), or 1915(k) 
of the Act program. The HCBS settings requirements describe how HCBS 
settings must offer community integration opportunities. Additionally, 
Sec.  438.3(f)(1), as proposed and finalized, requires all contracts to 
comply with the ADA, which describes the rights of people with 
disabilities including institutionalization issues. Because of these 
provisions, and because the LTSS definition is only intended to 
describe the scope to which the proposed rule managed LTSS regulations 
apply (rather than to create the substantive requirements that will 
apply to the provision of LTSS), we have decided not to adopt these 
requested changes to the definition.
    Comment: Many commenters recommended that CMS include specific 
services in the LTSS definition. The suggested services recommended by 
one or two commenters were orthotics, prosthetics, durable medical 
equipment, services that may prevent disability, medical supports such 
as medical adult day services and private duty nursing, community 
activities and supportive housing. Many commenters also suggested that 
there not be specific services included in the definition because it 
could serve to limit the scope of what would be considered LTSS. A few 
commenters suggested that CMS define the duration that services must be 
needed to qualify as LTSS.
    Response: We agree with the commenters who thought adding 
individual services in the definition could serve to limit the scope of 
what is covered by the LTSS provisions. We have therefore decided not 
to amend the LTSS definition to include any specific services. 
Additionally, because the duration of need to be LTSS is a state 
decision to be addressed in submissions to CMS and contracts with 
managed care plans, we decline to include such specificity in the LTSS 
definition in the final rule.
    Comment: The majority of commenters stated that the portion of the 
LTSS definition that reads ``have the primary purpose of supporting the 
ability of the beneficiary to live or work in the setting of their 
choice, which may include the individual's home, a provider-owned or 
controlled residential setting, a nursing facility or other 
institutional setting'' is confusing and/or misleading because it 
implies that the listed settings are the only ones where an individual 
may work. Many commenters suggested that the settings listed include an 
individual's workplace to clarify that a person may work somewhere 
other than a private home, residential or institutional setting. 
Another commenter recommended that ``shared living'' should be added as 
another setting.
    Response: We agree with the commenters who recommended that the 
settings listed should be expanded to include worksites so there are 
not unintended misinterpretations on where individuals may be supported 
to work. However, we believe that shared living arrangements would fall 
into the category of either a provider owned and controlled setting or 
an individual's home in which the individual has some form of tenancy 
agreement, so we do not agree that shared living as a setting for LTSS 
needs to be added to the definition. Therefore, we are modifying this 
section of the LTSS definition to include a worksite in the list of 
settings where an individual may be supported.
    After consideration of the public comments and for reasons outlined 
above, we are modifying the LTSS definition to state that long term 
services and supports (LTSS) means services and supports provided to 
beneficiaries of all ages who have functional limitations and/or 
chronic illnesses that have the primary purpose of supporting the 
ability of the beneficiary to live or work in the setting of their 
choice, which may include the individual's home, a worksite, a 
provider-owned or controlled residential setting, a nursing facility, 
or other institutional setting.
(2) Codifying MLTSS Guidance
    The principles in CMS' May 2013 guidance were developed after 
extensive review of numerous published findings, interviews with states 
as to lessons learned in the start-up and implementation of MLTSS 
programs, and recommendations from our HHS partners and other external 
stakeholders. The 10 elements identified in our 2013 guidance and used 
as the basis for our proposed regulation are:
    (1) Adequate Planning.
    (2) Stakeholder Engagement.

[[Page 27652]]

    (3) Enhanced Provision of Home and Community Based Services.
    (4) Alignment of Payment Structures and Goals.
    (5) Support for Beneficiaries.
    (6) Person-centered Processes.
    (7) Comprehensive, Integrated Service Package.
    (8) Qualified Providers.
    (9) Participant Protections.
    (10) Quality.
    In the preamble to the proposed rule, we described how we have 
incorporated these elements into the proposed rule. As noted 
previously, the elements were incorporated in proposed changes 
throughout this part, and we reference those sections of this final 
rule where the associated proposals are further discussed. In this 
section, we summarize the LTSS specific proposals and finalized 
regulations in the context of the ten elements of our guidance and 
explain how, together, they strengthen MLTSS programs. We requested 
comment on the incorporation of these elements in the proposed rule.
    Element 1: Adequate Planning: We believe the most effective MLTSS 
systems are the result of a thoughtful and deliberative planning 
process with a clear vision for the program. Thoughtful planning in the 
development of MLTSS programs helps to ensure a smooth transition for 
persons with LTSS needs as they transition from FFS to managed care 
delivery systems. We proposed to incorporate this element in the 
existing regulatory structure as follows:
     Amending Sec.  438.66 to propose that there is appropriate 
state monitoring and accountability of the program that includes 
readiness reviews. While this standard applies broadly to all managed 
care programs and is discussed in section I.B.6.c. of the proposed 
rule, LTSS, as a covered service under the contract, would be included 
in this review to the same extent as all other covered services.
     Amending Sec.  438.10 to propose additional standards for 
enrollee and potential enrollee materials, including information on 
transition of care, who to contact for support and other standards for 
provider directories. The specific proposed changes to Sec.  438.10 are 
discussed in the Information standards section of the proposed rule in 
section I.B.6.d. While LTSS is not specifically referenced, states 
(under Sec.  438.10(e)) and managed care plans (under Sec.  438.10(g) 
and (h)) would provide information on all covered benefits and provider 
directory information under our proposal.
    Element 2: Stakeholder Engagement: Successful MLTSS programs have 
developed a structure for engaging stakeholders regularly in the 
ongoing monitoring and oversight of the MLTSS program. Educated 
stakeholders, including beneficiaries, providers, and advocacy groups, 
inform decisions as to what works and what does not in the managed care 
system, allowing the state to design systems that are responsive to the 
needs of stakeholders and to address any implementation issues 
discovered early in the process. While Medicaid already has a standard 
for a Medical Care Advisory Committee (MCAC) outlined in Sec.  431.12 
and while in some states this forum has proved to be a useful venue for 
actionable feedback regarding a state's managed care program, we 
acknowledged that the MCAC in other states may not provide the 
opportunity to receive meaningful input from MLTSS stakeholders. Our 
proposed provisions for gathering stakeholder input are discussed in 
more detail in section I.B.5.h. of this final rule.
    Element 3: Provision of Home and Community Based Services: All 
MLTSS programs must be implemented consistent with the Americans with 
Disabilities Act (ADA) and the Supreme Court's Olmstead v. L.C., 527 
U.S. 581 (1999), decision. Accordingly, we proposed to be codified at 
Sec.  438.3(o), that all contracts with MCOs, PIHPs, and PAHPs comply 
with all applicable federal and state laws including the ADA under our 
current regulations. That proposal and the associated final rule 
provision is discussed in section I.B.2. of this final rule.
    Element 4: Alignment of Payment Structures and Goals: Payment to 
MCOs, PIHPs, and PAHPs should support the goals of MLTSS programs to 
improve the health of populations, support the beneficiary's experience 
of care, support community integration of enrollees, and reduce costs. 
We incorporated this element into our proposed rule under Sec.  438.66 
by proposing that states include MLTSS program elements in the annual 
program summary report. This proposal and how it is finalized is 
discussed in section I.B.6.c. of this final rule.
    Element 5: Support for Beneficiaries: Support and education, 
including enrollment and disenrollment assistance and advocacy support 
services, are critical for all beneficiaries in a MLTSS program. As 
discussed in more detail in section I.B.5.c of this final rule, we 
proposed to incorporate this element in Sec.  438.71, which would have 
states provide a beneficiary support system, including choice 
counseling services. While applicable to all managed care programs, the 
proposed changes to Sec.  438.71 would provide assistance to those with 
complex needs, such as those receiving LTSS, who would benefit most 
from these activities. As proposed in Sec.  438.71, states would 
incorporate four beneficiary support functions for all individuals 
using, or expressing a desire to use, LTSS within a managed care 
program:
     Provide an access point for complaints and concerns 
pertaining to the MCO, PIHP, PAHP, PCCM, or PCCM entity on the 
enrollment process, access to services, and other related matters 
(Sec.  438.71(e)(1)) (finalized as paragraph (d)(1));
     Educate beneficiaries on the grievance and appeal process, 
the state fair hearing process, enrollee rights and responsibilities, 
as well as resources outside of the MCO, PIHP or PAHP (Sec.  
438.71(e)(2)) (finalized as paragraph (d)(2));
     Assist in navigating the grievance and appeal process for 
MCOs, PIHPs and PAHPs or state fair hearing excluding providing 
representation (Sec.  438.71(e)(3)) (finalized as paragraph (d)(3)); 
and
     Review and oversight of LTSS program data to assist the 
state Medicaid Agency on identification, remediation, and resolution of 
systemic issues (Sec.  438.71(e)(4)) (finalized as paragraph (d)(4)).
    We also incorporated this element by proposing and finalizing a new 
for cause reason for disenrollment for enrollees receiving LTSS in 
Sec.  438.56(d)(2)(iv), which is discussed in section I.B.5.b. of this 
final rule. The proposal was based on recognition that provider network 
changes can have a significant impact on those enrolled in MLTSS 
programs, since some providers are integral to residential and 
employment services and supports. Therefore, if the state does not 
permit participants enrolled in MLTSS to switch managed care plans (or 
disenroll to FFS), at any time, states should permit MLTSS enrollees to 
disenroll and switch to another MCO, PIHP, PAHP, or FFS when the 
termination of a provider from their MLTSS network would result in a 
disruption in the enrollee's use of that provider. Under this proposal, 
an enrollee would be permitted to change their MCO, PIHP, or PAHP if 
their residential, institutional, or employment supports provider 
terminates their participation with the enrollee's current MCO, PIHP, 
or PAHP.
    Finally, as discussed at I.B.5.c., we proposed and finalized a new 
Sec.  438.816 that would describe the conditions that must be met for 
the state to claim FFP for the LTSS-specific beneficiary support system 
activities proposed in

[[Page 27653]]

Sec.  438.71(e) (and finalized as paragraph (d)). We modeled this 
standard, in part, on current rules for administrative services 
claiming and, in part, on the current rules for enrollment broker 
services. We proposed, consistent with our current policy, that 
beneficiary support services for MLTSS enrollees be eligible for 
administrative match subject to certain standards. Specifically, in 
paragraph (a), we proposed that costs must be supported by an 
allocation methodology that appears in the state's Public Assistance 
Cost Allocation Plan; in paragraph (b) that the costs do not duplicate 
payment for activities that are already being offered or should be 
provided by other entities or paid by other programs; in paragraph (c) 
that the person or entity providing the service must meet independence 
and conflict of interest provisions applicable to enrollment brokers in 
Sec.  438.810(b); and in paragraph (d) that the initial contract or 
agreement for services in this section be reviewed and approved by CMS.
    We noted in the preamble of the proposed rule that the proposed 
scope of services for LTSS beneficiary supports may include what has 
been traditionally considered ``ombudsman'' services; however, rules 
concerning Medicaid-reimbursable expenditures remain in place, so we 
cautioned that not all ombudsman activities traditionally found in a 
Long-Term Care Ombudsman office may be eligible for Medicaid payment 
under this proposal. We issued an informational bulletin on June 18, 
2013, entitled ``Medicaid Administrative Funding Available for Long-
Term Care Ombudsman Expenditures,'' that provided guidance on this 
issue. The informational bulletin is available at http://www.medicaid.gov/Federal-Policy-Guidance/downloads/CIB-06-18-2013.pdf.
    Element 6: Person Centered Process: Ensuring that beneficiaries' 
medical and non-medical needs are met and that they have the quality of 
life and level of independence they desire within a MLTSS program 
starts with person-centered processes including comprehensive needs 
assessments and service planning policies. We proposed to incorporate 
this element through proposed changes to Sec.  438.208(c) requiring 
identification, assessment, and treatment/service planning for 
individuals receiving LTSS who are enrolled in a MCO, PIHP or PAHP. 
This proposal, which is discussed and finalized in section I.B.5.e. of 
this final rule, would have an overall effect of shifting from a 
strictly medical, acute care focus to one that addresses all covered 
services.
    Element 7: Comprehensive, Integrated Service Package: In instances 
in which a state managed care program divides services between 
contracts or delivery systems, it is important that there is robust 
coordination and referral by the managed care plan to ensure that the 
beneficiary's service plan, which may include LTSS, is comprehensive 
and person-centered. We proposed to incorporate this element by 
proposing to expand Sec.  438.208(b)(2), so that MCOs, PIHPs, and PAHPs 
coordinate an enrollee's care between settings of care, with services 
received from another MCO, PIHP, or PAHP, and with services received 
from FFS. This proposal is discussed more fully and finalized in 
section I.B.5.e. of this final rule.
    Element 8: Qualified Providers: As with traditional managed care 
programs, MCOs, PIHPs, and PAHPs in a MLTSS program must have an 
adequate network of qualified providers to meet the needs of their 
enrollees. While current credentialing and network adequacy systems 
have been developed based on an acute and primary care service delivery 
model, managed care networks also meet the needs of MLTSS 
beneficiaries, including adequate capacity and expertise to provide 
access to services that support community integration, such as 
employment supports, and the provision of training and technical 
assistance to providers. We proposed the following changes to 
incorporate this element:
     Amending Sec.  438.68(b)(2) to propose that states 
establish time and distance standards specifically for MLTSS programs. 
This proposal addressed time and distance standards for LTSS provider 
types in which the enrollee must travel to the provider and the use of 
standards other than time and distance for LTSS provider types that 
travel to the enrollee to deliver the service. We believe it is 
important to recognize that standards must reflect the high utilization 
of services outside of the traditional medical office setting by 
enrollees using LTSS. Other changes to Sec.  438.68 are discussed in 
section I.B.6.a. of this final rule.
     Amending Sec.  438.206(c)(3) to propose that MCOs, PIHP, 
and PAHPs ensure that network providers have capabilities to ensure 
physical access, accommodations, and accessible equipment for enrollees 
with physical and mental disabilities. Given the high number of 
enrollees with a disability receiving some LTSS, we believed this to be 
an important factor when evaluating qualified providers in a MLTSS 
program. Other changes to Sec.  438.206 are discussed in section 
I.B.6.a. of this final rule.
     Amending Sec.  438.207(b)(1) to propose that MCOs, PIHPs, 
or PAHPs submit documentation to the state to demonstrate that it 
complies with offering the full range of preventive, primary care, 
specialty care, and LTSS services adequate for the anticipated number 
of enrollees. Under this proposal, the state would review the submitted 
documentation and certify its adequacy in paragraph (d) of this 
section. These changes are discussed in section I.B.6.a. of this final 
rule.
     Amending Sec.  438.214(b)(1) to propose that each state 
establish a credentialing and re-credentialing policy that addresses 
all the providers, including LTSS providers, covered in their managed 
care program regardless of the type of service provided by such 
providers. We proposed this to emphasize the importance of a 
credentialing and re-credentialing policy for all provider types for 
the services covered under the contracts. We also proposed that each 
MCO, PIHP, and PAHP must follow the state policy but did not propose to 
prohibit additional policies at the state or managed care plan level. 
These proposals, comments, and responses to the proposal, and the 
provisions of the final rule on this are discussed below in this 
section.
    Elements 9 and 10: Participant Protections and Quality: Participant 
health and welfare is an important tenet in a program providing LTSS. 
We incorporated these two elements by proposing to add a contract 
standard in Sec.  438.330(b)(6) that MCOs, PIHPs, and PAHPs participate 
in state efforts to prevent, detect, and remediate all critical 
incidents. We intended this standard to be interpreted to apply to 
incidents that adversely impact enrollee health and welfare and the 
achievement of quality outcomes described in the person centered plan. 
Under this proposal, states would specify the MCO, PIHP, or PAHP's 
roles and responsibilities related to these activities in the MCOs, 
PIHPs, and PAHP's contract.
    We noted in the proposed rule our belief that a quality system for 
MLTSS is fundamentally the same as a quality system for a state's 
entire managed care program, but should include MLTSS-specific quality 
elements. We specifically proposed Sec.  438.330(b)(5) to address 
specific MLTSS quality considerations. Under proposed paragraph (b)(5), 
the MCO, PIHP, or PAHP would have mechanisms to assess the quality and 
appropriateness of care provided to LTSS enrollees including between 
settings of care and as compared to the enrollee's service plan.

[[Page 27654]]

In addition, under Sec.  438.330(c)(1)(iii), we proposed that the state 
includes the results of any rebalancing efforts by the MCO, PIHP, or 
PAHP for individuals using LTSS in its annual program review. These 
provisions related to Sec.  438.330 are discussed in more detail in 
section I.B.6.b. of this final rule.
    These ten elements were the basis for many of our proposals related 
to LTSS provided through a managed care delivery system. We solicited 
comment on the extent to which our proposals--those discussed 
specifically above and the other LTSS-specific provisions in this final 
rule--successfully incorporate the elements.
    We received comments in response to our proposals; comments 
specific to proposals and finalized provisions discussed in more detail 
in other sections can be located in the section noted after each 
citation: Sec. Sec.  438.2 (definitions at I.B.5.g), 438.3 (standard 
contract provisions at I.B.2), 438.10 (information requirements at 
I.B.6.d), 438.66 (state monitoring standards at I.B.6.c), 438.68 
(network adequacy standards at I.B.6.a), 438.70 (stakeholder engagement 
for MLTSS at I.B.5.h), 438.71 (beneficiary support system at I.B.5.c), 
438.206 (availability of services at I.B.6.a), 438.207 (assurances of 
adequate capacity and services at I.B.6.a), and 438.816 (beneficiary 
support system at I.B.5.c). We discuss our proposals, comments, and 
responses, and finalized provisions related to Sec.  438.214 here.
    We received the following comments in response to our proposal in 
Sec.  438.214.
    Comment: We received several comments recommending that CMS require 
states to permit, and ideally require, managed care plans to delegate 
credentialing of clinicians to FQHCs who undergo the Federal Torts 
Claims Act credentialing process. Commenters generally stated that such 
delegation is not inconsistent with the requirement to establish a 
``uniform credentialing and recredentialing policy'' under paragraph 
Sec.  438.214(b)(1).
    Response: Decisions on the permissibility and extent of delegated 
credentialing rest with the states. We do not believe it is appropriate 
or necessary for that to be specified in Sec.  438.214, because we 
maintain that states are in the best position to understand and 
articulate standards for their states. States are in the best position 
to address the nuance of the scopes of practice, disciplinary board, 
and availability of information for other credentialing criteria.
    Comment: A few commenters requested that Sec.  438.214(c) include a 
reference to section 1557 of the Affordable Care Act.
    Response: We appreciate the opportunity to clarify that, as 
provided in Sec.  438.3(f)(1), all Medicaid managed care plan contracts 
must comply with all applicable federal and state laws and regulations 
including Title VI of the Civil Rights Act of 1964; Title IX of the 
Education Amendments of 1972 (regarding education programs and 
activities); the Age Discrimination Act of 1975; the Rehabilitation Act 
of 1973; the Americans with Disabilities Act of 1990 as amended; and 
section 1557 of the Patient Protection and Affordable Care Act. Under 
these identified statutes and their implementing regulations, managed 
care plans are prohibited from discriminating against providers (for 
example, rejecting a provider's participation in a plan's network) on 
the basis of the provider's race, color, national origin, disability, 
age, or sex. The department's 1557 guidance and the final 1557 
regulation provide more information on what constitutes sex 
discrimination. See www.hhs.gov/ocr. Other laws, such as state laws, 
that prohibit discrimination may also be applicable to manage care 
plans.
    Comment: We received some comments on the language ``uniform 
credentialing and recredentialing policy'' in proposed Sec.  
438.214(b). The commenters believed that this provision, if applied to 
all providers, is unnecessarily burdensome and fails to acknowledge the 
unique nature of different types of providers, particularly when 
considering LTSS services or services provided by non-licensed 
providers. One commenter believed that unlicensed provider types must 
be credentialed and that setting training requirements might be a 
method of addressing this issue, while ensuring that LTSS consumers are 
served by qualified providers. One commenter recommended that CMS 
require that governance, leadership, and financial viability be 
included in LTSS credentialing policies. Another commenter recommended 
that states should have discretion in determining the categories of 
LTSS providers that should be credentialed when alternative methods of 
assuring quality care and beneficiary protection may be sufficient.
    Response: We appreciate the opportunity to clarify our intent in 
proposed Sec.  438.214(b). Our use of ``uniform'' was not intended to 
convey that credentialing policies and procedures had to be identical 
for all provider specialties and types. That would be unrealistic and 
inappropriate. Our intent was to convey that credentialing and 
recredentialing policies need to be consistently developed and applied 
to ensure accurate and equitable outcomes, to prevent discriminatory 
practices, and enable managed care plans to build and maintain networks 
that meet the needs of their enrollees. We acknowledge and agree that 
credentialing policies must be tailored by provider type or specialty 
to appropriately reflect criteria such as education, training, 
experience, and/or licensure or certification.
    Given the challenges of determining common criteria among certain 
types of LTSS providers, selecting appropriate criteria becomes even 
more important. As one commenter suggested, training may be a method to 
help address this for some LTSS providers. Lastly, we interpret the 
comment requesting that the state have discretion to determine which 
types of LTSS providers to credential to mean that states want to be 
able to have no credentialing or evaluation process at all for certain 
LTSS providers when alternative methods of assuring quality care and 
beneficiary protection may be sufficient. If that interpretation is 
correct, then we restate that LTSS providers, regardless of the type of 
service provided, must undergo the credentialing and recredentialing 
process. We note that the criteria for credentialing may differ based 
on the type of LTSS provider.
    In a self-directed model, there may be individual credentialing 
based on beneficiary-defined parameters, along with certain state-wide 
criteria such as passing a criminal background and fraud check, and/or 
being of age to perform the work. When an individual specifies self-
directed provider enrollment criteria, the state must have or delegate 
to the managed care entities a process by which the provider 
credentials are verified, and that safety monitoring and appropriate 
payment oversight occurs. This usually occurs through a financial 
management services entity qualified to perform payroll and other 
actions on behalf of the self-directing individual. We do not agree 
that assurances of quality of care or other beneficiary protections 
would be sufficient unless used in a well-structured self-direction 
program as a post review process where beneficiary risk and mitigation 
has been worked through at initiation of services in a person-centered 
planning process.
    Comment: We received one comment suggesting that states have a 
centralized credentialing approach throughout the state, particularly 
for anesthesiologists, radiologists, pathologists, emergency room 
physicians, per diem, and locum tenens providers, and facilities.

[[Page 27655]]

    Response: The decision to operate a centralized credentialing 
approach is a state decision and currently permitted at Sec.  
438.214(a); we do not believe that additional text in the regulation at 
Sec.  438.214 is necessary to permit this.
    Comment: One commenter recommended that CMS require that licensing 
be instituted in all states. The commenter believed that certain states 
do not require that all LTSS providers--such as home care agencies 
providing personal care services--be licensed, and thus prevents 
appropriate credentialing.
    Response: Section 438.214 only sets forth the minimum federal 
requirements for provider selection. We believe the decision to require 
or mandate licensure requirements for specific LTSS providers should be 
at the state's discretion. Therefore, we decline to add additional text 
in the regulation.
    Comment: A few commenters recommended that any credentialing 
requirements that apply to network providers of managed care plans be 
equally applied to FFS programs to promote consistent beneficiary 
rights across the Medicaid program.
    Response: Mandating credentialing requirements in the context of 
FFS programs is outside the scope of this rule.
    Comment: We received a few comments recommending that CMS establish 
a time frame for managed care plans to act on credentialing 
applications and require that, once a provider is credentialed, the 
managed care plan should consider them as a participating provider and 
pay any claims for services back to the date of the provider's 
credentialing application to the managed care plan. Another commenter 
recommended that CMS require managed care plans to publicly report (on 
the state Web site) the average length of time each managed care plan 
takes to process credentialing applications, starting from the date 
that a complete application package is received.
    Response: We believe that setting specific timeframes for 
credentialing processes, disclosure of processing times, and any 
payment requirements are decisions best made by each state, which may 
choose to leave such decisions regarding network composition and the 
business relationship between plans and providers to the MCOs, PIHPs 
and PAHPs. We decline to revise Sec.  438.214 as recommend by these 
comments.
    Comment: One commenter suggested that managed care plans get input 
on the development of their LTSS credentialing policies from LTSS 
providers.
    Response: We agree that getting input from LTSS providers could be 
a valuable source of information and encourage states and managed care 
plans to consider it. However, we decline to make this a requirement in 
this final rule.
    Comment: We received a few comments that recommend that managed 
care plans must ensure that their credentialing process is developed in 
a way that does not ``medicalize'' LTSS or unintentionally impede HCBS 
providers from participating in the system of care.
    Response: We agree that managed care plans need to develop their 
credentialing policies and procedures consider the unique features and 
nature of LTSS, which is different than the feature applicable acute 
care. This is consistent with our intent throughout this rule and we 
encourage states and plans to review existing policies and procedures 
to ensure that they reflect this perspective. We believe that the 
regulation text is sufficient that different standards are appropriate 
for different types of providers and do not plan to finalize additional 
text on this point.
    Comment: We received one comment suggesting that CMS add pediatric 
nurse practitioners and other licensed providers and facilities that 
meet the standard for accreditation to the list of providers in 
proposed Sec.  438.214(b).
    Response: The list in Sec.  438.214(b)(1) is a minimum and states 
are free to add provider types as they deem appropriate. We decline to 
revise Sec.  438.214 as recommended in this comment.
    Although not proposed, we are making two technical corrections in 
Sec.  438.214. In paragraphs (a), (b)(2), and (c), we are adding 
``network'' before ``provider'' for accuracy given that these 
paragraphs address topics applicable only to network providers, that 
is, contracts, credentialing, and provider selection. In paragraph 
(b)(2), we are deleting ``who have signed contracts with the MCO, PIHP, 
or PAHP'' to remove the redundancy that phrase adds given the 
definition of ``network provider'' in Sec.  438.2.
    After consideration of public comments, we are finalizing Sec.  
438.214 as proposed without modification.
h. Stakeholder and Member Engagement in LTSS (Sec.  438.70 and Sec.  
438.110)
    Since stakeholder and member engagement plays a critical role in 
the success of a MLTSS program, we proposed that states and managed 
care plans must have appropriate minimum mechanisms in place to 
accomplish this in a new Sec.  438.70 regarding the state's creation 
and maintenance of a stakeholder group so that opinions of 
beneficiaries, providers, and other stakeholders are solicited and 
addressed during the design, implementation, and oversight of the MLTSS 
program. We proposed that states set the composition of the stakeholder 
group and the frequency of meetings to ensure meaningful stakeholder 
engagement. Our proposal specifically uses a ``sufficiency'' standard 
rather than setting quantitative parameters for the composition of the 
group or the frequency of meetings to permit states a significant 
degree of flexibility. We requested comments on the overall approach 
for these changes, as well as on the composition of the stakeholder 
group, stakeholder group responsibilities, and approach to meeting 
frequency for both states and managed care plans.
    In concert with the new Sec.  438.70, we also proposed a new Sec.  
438.110. While the stakeholder group proposed in Sec.  438.70 is 
maintained by the state, we believe that each MCO, PIHP, and PAHP 
should also establish a regular process to solicit direct input on the 
enrollees' experiences. Therefore, in Sec.  438.110(a), we proposed 
that for any MCO, PIHP, or PAHP contract that includes LTSS, the MCO, 
PIHP, or PAHP must establish and maintain a member advisory committee. 
Paragraph (b) proposed that the member advisory committee include a 
reasonably representative sample of the covered LTSS populations. We 
included PAHPs in this standard, because we understand there are some 
PAHPs in operation that cover LTSS. We have combined our discussion of 
the requirements in Sec. Sec.  438.70 and 438.110 throughout this 
section; therefore we use the terms stakeholders and members 
interchangeably when referring to the general requirements for a state 
to establish and maintain a state stakeholder group in Sec.  438.70 and 
for the MCO, PIHP, or PAHP to establish and maintain a member advisory 
committee in Sec.  438.110.
    We received the following comments in response to our proposal to 
add a new Sec. Sec.  438.70 and 438.110.
    Comment: One commenter recommended there should be no state level 
stakeholder engagement and that all stakeholder engagement should be 
through managed care plans, although many other commenters wrote in 
support of stakeholder engagement at the state level. Many commenters 
suggested that CMS define ``stakeholder'', the term ``meaningful 
input'', the number of stakeholders that should be represented, the 
frequency at which the stakeholders meet with the

[[Page 27656]]

state and/or the roles of stakeholders who are engaged at the state 
level regarding the managed care program.
    Response: We are appreciative of the many comments supporting 
stakeholder involvement. We also appreciate the suggestions to define 
several terms used in this section and the recommendations to set more 
specific requirements, but we decline to do so. We believe that the 
critical stakeholders would be those who are directly affected by the 
managed care program, and so would vary from state to state. 
Beneficiaries and providers are already specified in this section, and 
additional stakeholders may include beneficiary family members or 
representatives, caregivers, advocates, regional and tribal 
representation, specific ethnic populations or representatives of other 
groups deemed by the state to be sufficient to allow for meaningful 
engagement. We would anticipate that the frequency of meetings would 
vary based on the age and stability of the program. A program being 
developed and/or modified significantly may need monthly or more 
frequent meetings, while a program that has been running for a number 
of years may be well-served through quarterly or semi-annual meetings. 
The number of stakeholders is also rightly a variable for several 
reasons, such as the size and scope of the MLTSS program. Questions 
that would trigger different types of stakeholder input could include 
whether the program is very large and run statewide, or more local, and 
what types of LTSS are offered, and what types of individuals are 
served by the plans--elders, people with disabilities, and/or people 
with certain types of disabilities. Meaningful stakeholder input would 
be defined by whether the major constituency groups in a given state 
affected by the LTSS program have the ongoing forum to express program 
issues and concerns. We believe it would be impossible for us to create 
definitions and more specific standards that would be appropriate for 
all MLTSS programs in every state and decline to do so in this 
regulation.
    Comment: Many commenters recommended that CMS identify which 
particular providers, constituents, or stakeholders must be included in 
the state stakeholder group or member advisory committee. Specifically, 
at least one commenter each thought CMS should require consumer 
advocacy groups/disability support agencies, home-based providers, 
rehabilitation professionals (Physical, Occupational or Speech 
therapists), state Olmstead committee representation, Area Agencies on 
Aging, hospice providers, healthcare professionals (pharmacist, nurse, 
physician), Pacific Islanders, Native Americans, people with 
disabilities, people with severe mental health issues, staff from the 
Beneficiary Support System (see Sec.  438.71), family members, at least 
one of each provider type, and managed care plan representatives. One 
commenter thought that one statewide committee representing everyone 
would be too large, another thought managed care entity representatives 
should be limited, and yet another that there should be a minimum 
required number of beneficiaries.
    Response: We agree that any of these suggested participants may be 
appropriate candidates for the state stakeholder group or member 
advisory committee, but believe the actual composition of the group 
that includes those most affected by a given state program is best 
determined by the state. We agree that family members or other 
individuals that represent enrollees are always a critical stakeholder 
component. Therefore, we are adding representatives of beneficiaries or 
enrollees to the list of individuals who should be part of the state 
stakeholder group and to the managed care plan member advisory 
committee in Sec. Sec.  438.70 and 438.110, as finalized here. We 
caution that there is also a need to include beneficiaries on these 
committees who can represent themselves as they may have somewhat 
different priorities than family members in regard to LTSS. This is why 
we are leaving beneficiaries and individuals that represent enrollees 
as two different categories of participants. We believe that both 
states and managed care plans are in the position to best determine how 
many of each type of stakeholder will best represent those most 
affected by the managed LTSS programs, and that both states and managed 
care plans need to have flexibility to determine the mix and number of 
stakeholders and members in the respective groups.
    Comment: A few commenters thought CMS should require public comment 
on any proposed managed care program or program amendment, while a few 
commenters requested ongoing general stakeholder input outside of a 
committee structure. One commenter recommended that stakeholders should 
have approval authority over state programmatic decisions, where 
several commenters thought the states should respond on a Web site to 
all public comments.
    Response: Although we encourage states to maintain strong 
communications with stakeholders even beyond the requirements of this 
regulation, we believe the stakeholder engagement process required here 
along with the managed care plan member advisory committees (at Sec.  
438.110), Beneficiary Support System (Sec.  438.71), Quality 
Measurement and Reporting (42 CFR part 438 subpart E), Grievance and 
Appeal systems (42 CFR part 438 subpart F) and the reporting 
requirements for each of these requirements is sufficient to ensure 
that stakeholder concerns are identified and addressed. Most new 
managed LTSS programs already must go through a public comment period 
either through the section 1115(a) demonstration process, or by virtue 
of having a concurrent section 1915(c) home and community based 
services submission. Where states have the responsibility for the 
operation of Medicaid programs within federal guidelines, it would not 
be appropriate or within our jurisdiction to mandate that stakeholders 
have the authority to override those decisions.
    Comment: A commenter recommended that CMS provide training to the 
stakeholder group. A few commenters suggested that stakeholders should 
be given advance notification of any new information prior to the 
committee meetings, and a few suggested that the stakeholders should 
review and advise on quality measures and results. One commenter 
thought the stakeholder process should be in place prior to contract 
finalization with the managed care plans, and another thought there 
should be a federal stakeholder process. One commenter asked that 
members be mandated to attend, and several others thought the 
regulation should require states to provide supports for individuals to 
participate such as transportation or personal care assistance. 
Finally, several commenters thought there should be a stakeholder 
engagement evaluation conducted by states to measure effectiveness or a 
type of financial incentive arrangement for managed care plans that 
excel at stakeholder engagement.
    Response: We agree that the stakeholder community should be 
informed about the program the state is proposing to provide meaningful 
input. However, we believe this is implicit in Sec.  438.70 that 
stakeholder views must be solicited. We are not aware of any 
stakeholder process in a state where individuals were asked to give 
opinions without first being given a description of the program to be 
discussed. We also agree that it is desirable to have information 
shared ahead of a meeting, but understand that sometimes the state 
itself does not have advance notice. We believe a requirement for 
advance notice

[[Page 27657]]

on items may result in a state being unable to share time sensitive 
items that have little turnaround time, so we decline to amend the 
regulation in this manner.
    We concur that individuals must be offered accommodations to 
participate in stakeholder engagement activities. This could include 
telephonic meetings, use of computer messaging, interpreter services, 
or other means identified by participants that may be necessary to 
participate. The ADA requires reasonable accommodations for persons 
with disabilities, so we do not believe the need for accommodations 
should be specified here as well. In regard to stakeholder engagement 
performance reviews or payment incentives, we are not aware of 
evidence-based standards upon which such an evaluation or payment could 
be based. We are, therefore, not adding an evaluation component to 
stakeholder engagement at this time.
    Comment: Many commenters supported Sec.  438.110(a) requiring 
managed care plans to establish and maintain a member advisory 
committee when LTSS are covered under a risk contract. Several 
commenters recommended that CMS provide additional specificity 
regarding this requirement. Commenters recommended that CMS add 
requirements for member advisory committee operations, 
responsibilities, transparency requirements, public notice 
requirements, and committee meeting frequency standards. Specifically, 
commenters recommended that CMS add specificity for member advisory 
committee participation in program policy development, program 
administration, program oversight, quality activities, appeals and 
grievances reporting, data from member and provider satisfaction 
surveys, and periodic program updates. A few commenters recommended 
that member advisory committees be required to meet at least quarterly. 
One commenter also recommended that CMS remove the requirement 
triggering Sec.  438.110 that LTSS be covered under a risk contract 
through an MCO, PIHP, or PAHP, as PCCM entities are evolving to cover 
LTSS and should not be exempt from the member advisory committee 
requirement. One commenter did not support Sec.  438.110(a) and 
recommended that CMS remove the requirement in entirety, as states and 
managed care plans should be given flexibility to determine the most 
effective process for member input.
    Response: We thank commenters for their support and thorough 
recommendations for Sec.  438.110(a). While we understand commenters' 
concerns regarding the lack of specificity in the requirement for 
managed care plans to establish and maintain a member advisory 
committee, we believe that states and managed care plans should work 
with their stakeholder communities to establish the most effective and 
efficient process for member engagement. We therefore decline to add 
commenters' detailed requirements to the regulatory text, as we believe 
that such requirements are overly prescriptive and would not allow the 
appropriate level of flexibility to design the stakeholder engagement 
process for LTSS programs. We note that states can establish such 
detailed requirements in their contracts with managed care plans.
    We also decline to remove the requirement that LTSS be covered 
under a risk contract through an MCO, PIHP, or PAHP as a condition for 
the requirements in Sec.  438.110 to apply, as we do not believe that 
PCCM entities are directly providing LTSS and are instead focused 
solely on care coordination activities and arranging for the provision 
of services outside of the PCCM entity. While we do not believe that it 
would be appropriate for such PCCM entities to be required to establish 
and maintain a member advisory committee, we encourage states to 
consider how their PCCM entities operate in determining whether to 
impose a stakeholder engagement or member advisory committee 
requirement in the state contract. Finally, we decline to remove Sec.  
438.110(a) in entirety, as we disagree with the commenter that states 
and managed care plans should be given discretion on whether to 
establish and maintain a member advisory committee. We believe that the 
establishment and maintenance of a member advisory committee is a 
critical beneficiary protection to ensure that enrollees' feedback is 
heard and included as appropriate when those enrollees are receiving 
LTSS services.
    Comment: Several commenters recommended that CMS add specificity at 
Sec.  438.110(b) regarding committee composition. Commenters 
recommended that CMS add requirements for managed care plans to include 
consumers, enrollees, family members, service providers, and advocates. 
Several commenters recommended that CMS define ``LTSS populations'' and 
``reasonably representative.'' Other commenters recommended that CMS 
include specific thresholds for committee composition, such as 50 
percent of committee members must be consumers and enrollees. One 
commenter recommended that CMS add the phrase ``or other individuals 
representing those enrollees'' after ``LTSS populations.''
    Response: Consistent with our approach at Sec.  438.110(a), we 
believe that states and managed care plans should work with their 
stakeholder communities to establish the most effective and efficient 
process for member engagement and therefore we decline to implement 
commenters' detailed recommendations, as we believe that such 
requirements are overly prescriptive and would not allow the 
appropriate level of flexibility for LTSS programs. However, we agree 
with the commenter that the phrase ``or other individuals representing 
those enrollees'' after ``LTSS populations'' should be added to the 
regulatory text, as we believe it would be beneficial to include 
individuals who represent LTSS enrollees. We are modifying the 
regulatory text to adopt this recommendation.
    Comment: A few commenters recommended that CMS establish broader 
requirements for a statewide managed care advisory committee or board. 
One commenter also recommended that CMS include requirements for states 
to establish consumer advisory committees. One commenter recommended 
that CMS include requirements for states to establish pediatric 
advisory committees, especially for children with special health care 
needs.
    Response: While we understand commenters' concerns regarding 
stakeholder feedback and appropriate representation, we believe these 
recommendations are duplicative of the requirement at Sec.  431.12 of 
this chapter, requiring states to establish and maintain a Medical Care 
Advisory Committee. This committee is required to include 
representatives who are familiar with the medical needs of low-income 
population groups and with the resources available and required for 
their care. The committee is also required to include members of 
consumer groups, including Medicaid beneficiaries and consumer 
organizations. We therefore decline to accept commenters' 
recommendations to establish broader requirements for more managed care 
advisory committees; we are finalizing only the two specific committees 
that were proposed.
    Comment: A few commenters recommended that CMS establish 
requirements to support enrollees who participate on member advisory 
committees. Specifically, commenters recommended that CMS require

[[Page 27658]]

managed care plans to support and facilitate enrollee participation, 
including transportation, interpreter services, personal care, 
compensation, and other enrollee supports that will encourage 
participation.
    Response: While we encourage states and managed care plans to 
establish mechanisms, where appropriate and feasible, to support 
enrollees who participate on member advisory committees, we decline to 
adopt commenters' specific recommendations to require that managed care 
plans provide transportation, interpreter services, personal care, 
compensation, and other enrollee supports that encourage participation. 
We believe that states and managed care plans should work with their 
stakeholder communities to establish the most effective and efficient 
process for member engagement, including the best methods for 
encouraging and supporting enrollee participation on member advisory 
committees.
    After consideration of the public comments, we are finalizing 
Sec. Sec.  438.70 and 438.110 as proposed with a revision to include 
other individuals that represent beneficiaries or enrollees to the list 
of individuals included in the committees required by the two 
regulations.
6. Modernize Regulatory Standards
a. Availability of Services, Assurances of Adequate Capacity and 
Services, and Network Adequacy Standards (Sec. Sec.  438.206, 438.207, 
438.68, 440.262)
    As indicated in I.B.6.a of the proposed rule, assessment of the 
network adequacy of contracted MCOs, PIHPs, and PAHPs is a primary 
component of our determination of a state's readiness to implement and 
sustain managed care programs. We proposed a new regulation section and 
revisions to existing regulations to establish minimum standards in 
this area. The proposed changes had the goal of maintaining state 
flexibility while modernizing the current regulatory framework to 
reflect the maturity and prevalence of Medicaid managed care delivery 
systems, promoting processes for ensuring access to care, and aligning, 
where feasible, with other private and public health care coverage 
programs. To that end, we proposed to set standards to ensure ongoing 
state assessment and certification of MCO, PIHP, and PAHP networks, set 
threshold standards for the establishment of network adequacy measures 
for a specified set of providers, establish criteria for developing 
network adequacy standards for MLTSS programs, and ensure the 
transparency of network adequacy standards. These proposed changes 
would create a new Sec.  438.68 specific to the development of network 
adequacy standards for medical services and LTSS and modify Sec. Sec.  
438.206 and 438.207.
    (1) Requirements for the Network Adequacy Standards set by the 
State for a Specified Set of Providers (Sec.  438.68)
    Our current regulatory framework provides states with significant 
flexibility to determine whether an MCO, PIHP, or PAHP adequately makes 
services accessible and available to enrollees under the managed care 
contract. Because our existing regulations were developed at a time 
when managed care for the delivery of LTSS was extremely limited and 
involved only a handful of programs limited in geographic scope, we 
proposed to amend the existing regulations to establish standards for 
states to follow in the development of Medicaid managed care network 
adequacy standards that address medical services, behavioral health 
services, and LTSS. In accordance with our underlying goal to align 
Medicaid managed care standards with other public programs where 
appropriate, we analyzed the network adequacy standards applicable 
under the Marketplace and the MA program to inform our proposed rule. 
In section I.B.6.a of the proposed rule, we provided a short summary of 
the standards utilized by these programs.
    Similar to the rules finalized for Marketplaces and QHPs, the 
existing network adequacy standards for Medicaid managed care do not 
include detailed and specific time and distance standards or provider 
to enrollee ratios but deferred to each state to develop specific 
standards; the current regulations rely heavily on attestations and 
certifications from states, with supporting documentation, about the 
adequacy of the network. Consistent with the primary role of states in 
Medicaid, our proposal kept to this general approach. Therefore, we 
proposed to add a new Sec.  438.68 that would stipulate that the state 
must establish, at a minimum, network adequacy standards for specified 
provider types.
    Proposed paragraph (a) specified that a state that contracts with 
an MCO, PIHP, or PAHP must develop network adequacy standards that 
satisfy the minimum parameters in Sec.  438.68. This proposed provision 
is the counterpart to our proposal at Sec.  438.206 that the state 
ensures that enrollees of MCOs, PIHPs, and PAHPs have access to all 
services covered under the state plan in a manner that is consistent 
with the state-set standards for access and availability. These 
proposals would apply to contracts that cover medical services, 
behavioral health services, and LTSS; the standards for LTSS proposed 
in paragraphs (b)(2) and (c)(2) are described in the MLTSS-specific 
discussion at the end of this section.
    Proposed paragraph (b)(1) would stipulate that states must 
establish time and distance standards for the following network 
provider types: Primary care (adult and pediatric); OB/GYN; behavioral 
health; specialist (adult and pediatric); hospital; pharmacy; pediatric 
dental; and additional provider types when it promotes the objectives 
of the Medicaid program for the provider type to be subject to such 
time and distance standards. We intended that this proposal be 
applicable only to the services covered under the MCO, PIHP, or PAHP 
contract(s). We proposed that states, at a minimum, establish time and 
distance standards as such standards are currently common in the 
private market and many state Medicaid managed care programs; further, 
we believe time and distance standards present a more accurate measure 
of the enrollee's ability to have timely access to covered services 
than provider-to-enrollee ratios. We requested comment on whether we 
should propose a different national type of measure for states to 
further define, such as provider-to-enrollee ratios, or whether we 
should permit states the flexibility to select and define the type of 
measure for the network's adequacy of the specified provider types. 
Additionally, we requested comment on whether we should define the 
actual measures to be used by states such that we would set the time 
and distance or provider-to-enrollee ratio standard per provider type, 
per county, or other appropriate geographic basis.
    Given the large number of pediatric Medicaid enrollees, we noted 
that it is important for states and plans to specifically include 
pediatric primary, specialty, and dental providers in their network 
adequacy standards. Network adequacy is often assessed without regard 
to practice age limitations, which can mask critical shortages and 
increase the need for out-of-network authorizations and coordination. 
We requested comment on whether standards for behavioral health 
providers should distinguish between adult and pediatric providers. We 
considered adding family planning providers to the list of providers 
that would be subject to time and distance standards but declined to do 
so because section 1902(a)(23) of the Act guarantees freedom of choice 
of family planning

[[Page 27659]]

providers and providers of family planning services would include 
physicians and OB/GYNs. We requested comment on this approach.
    Appreciating that provider networks can vary between geographic 
areas of a state and states have different geographic areas covered 
under managed care contracts, as proposed in paragraph (b)(3), states 
would have to establish time and distance standards for specified 
provider types that reflect the geographic scope of the Medicaid 
managed care program. Our proposal would permit states to vary those 
standards in different geographic areas to account for the number of 
providers practicing in a particular area. Our proposal would not limit 
states to only the mandatory time and distance standards but also would 
have states consider additional elements when developing network 
adequacy standards.
    Proposed paragraph (c)(1) specifies the minimum factors a state 
must consider in developing network adequacy standards; most of the 
elements proposed here are currently part of Sec.  438.206(b)(1) as 
considerations for MCOs, PIHPs, and PAHPs in developing their managed 
care networks. These are: Anticipated Medicaid enrollment; expected 
utilization of services; taking into account the characteristics and 
health needs of the covered population; number and types of health care 
professionals needed to provide covered services; number of network 
providers that are not accepting new Medicaid patients; and the 
geographic location and accessibility of the providers and enrollees.
    Disparities in access to care related to demographic factors such 
as race, ethnicity, language, or disability status are, in part, a 
function of the availability of the accessible providers who are 
willing to provide care and are competent in meeting the needs of 
populations in medically underserved communities. Additionally, new 
enrollees in Medicaid managed care, including those who are dually 
eligible for Medicare and Medicaid, may present with multiple chronic 
conditions and need the services of multiple specialists. Absent an 
adjustment for new populations enrolled in a state's Medicaid managed 
care program, existing plan networks may be inadequate to meet new 
enrollees' needs.
    Accordingly, we proposed changes to the required factors that we 
proposed to move from current Sec.  438.206(b)(1). We proposed to make 
existing Sec.  438.206(b)(1)(ii) into separate factors that the state 
must consider: Expected utilization and the characteristics and health 
needs of the covered population; these are codified as Sec.  
438.68(c)(1)(ii) and (iii) and use substantially the same language as 
in the current regulation. Similarly, we proposed two separate factors, 
to be codified at Sec.  438.68(c)(1)(vi) and (viii), in place of the 
current Sec.  438.206(b)(1)(v), which are geographic location and 
accessibility. Although we proposed to use the same language regarding 
geographic considerations, we proposed in Sec.  438.68(c)(1)(viii) that 
each state must also consider the ability of providers to ensure 
physical access, accommodations, and accessible equipment available for 
Medicaid enrollees with physical or mental disabilities, with proposed 
additional standards that the accommodations be reasonable and that the 
ability of providers to ensure culturally competent communication be 
considered as well. Also, we proposed to add a new element, at proposed 
paragraph (c)(1)(vii), so that states must also consider the ability of 
network providers to communicate with limited English proficient (LEP) 
enrollees in their preferred language when the state is developing time 
and distance access standards.
    In effect, our proposal was that the states develop standards by 
which to review the provider networks used in Medicaid managed care, 
which should ensure that these elements are also taken into 
consideration by MCOs, PIHPs, and PAHPs that maintain and monitor the 
provider networks. We intended that compliance with our proposal would 
be best met if states looked to standards established by the insurance 
regulator (for example, Department of Insurance, or similar agency 
within the state) for private market insurance, and the standards set 
under the MA program, as well as historical patterns of Medicaid 
utilization--including utilization specific to sub-populations that may 
be more relevant to the Medicaid program than in private or Medicare 
markets--to inform the standards the state establishes for Medicaid 
managed care programs under Sec.  438.68. While we did not propose to 
dictate the particular time and distance standards or set a 
quantitative minimum to be adopted by a state, we noted our intent to 
assess the reasonableness of the particular standard adopted by a state 
under our proposed Sec.  438.68 within the context of other existing 
standards should the need for such evaluation of the state's 
performance arise.
    We recognized that situations may arise where a MCO, PIHP, or PAHP 
may need an exception to the state established provider network 
standards. A number of states currently permit exceptions, and have a 
process for seeking exceptions, under the state standards imposed on a 
managed care entity under existing Sec. Sec.  438.206 and 438.207. 
Therefore, proposed Sec.  438.68(d) provides that, to the extent a 
state permits an exception to any of the provider network standards, 
the standard by which an exception would be evaluated must be specified 
in the contract and must be based, at a minimum, on the number of 
health care professionals in that specialty practicing in the service 
area. Under our proposal, the state would monitor enrollee access to 
providers in managed care networks that operate under an exception and 
report its findings to us as part of its annual managed care program 
monitoring report provided under proposed Sec.  438.66. We invited 
comment on our proposal related to exceptions a state may grant to its 
network adequacy standards established by the state for Medicaid MCOs, 
PIHPs, or PAHPs.
    Finally, in proposed paragraph (e), to promote transparency and 
public input for these managed care network adequacy standards, we 
proposed that states would have to publish the network adequacy 
standards developed in accordance with Sec.  438.68 on the Medicaid 
managed care Web site under Sec.  438.10. In addition, states would 
have to make these standards available at no cost, upon request, to 
individuals with disabilities through alternate formats and using 
auxiliary aids and services.
    We received the following comments in response to our proposal to 
add a new Sec.  438.68 that would stipulate that the state must 
establish, at a minimum, network adequacy standards for specified 
provider types.
    Comment: Many commenters supported proposed Sec.  438.68(b)(1) that 
would require states to develop network adequacy standards for a 
distinct set of provider types and categories, including (i) adult and 
pediatric primary care; (ii) OB/GYN; (iii) behavioral health; (iv) 
adult and pediatric specialist; (v) hospital; (vi) pharmacy; (vii) 
pediatric dental; and (viii) additional provider types when it promotes 
the objectives of the Medicaid program, as determined by CMS. Many 
commenters specifically recommended additional provider types and 
categories for CMS to include at Sec.  438.68(b)(1). In total, 
commenters recommended more than 30 additional provider types and 
categories. One commenter recommended that CMS remove the language at

[[Page 27660]]

Sec.  438.68(b)(1)(viii) pertaining to ``additional provider types when 
it promotes the objectives of the Medicaid program, as determined by 
CMS'' because the language is too broad. Finally, in response to our 
request for comment to add family planning providers to the list of 
providers that would be subject to time and distance standards, several 
commenters recommended that CMS finalize the regulation with family 
planning providers included in the network adequacy standards.
    Response: We thank commenters for their support of proposed Sec.  
438.68(b)(1). We decline to list additional provider types and 
categories as commenters recommended. We believe that the proposed list 
strikes the appropriate balance of ensuring access to care and state 
flexibility. States have the authority to add additional provider types 
to their network adequacy standards to reflect the intricacies of their 
Medicaid programs. We also decline to remove the proposed language at 
Sec.  438.68(b)(1)(viii). We believe this flexibility is important to 
address future national provider workforce shortages and future network 
adequacy standards. If we apply this flexibility and the regulation 
standard to identify additional provider types for which a state should 
establish time and distance standards, we intend to solicit public 
input. Consistent with both our rationale as described in the proposed 
rule (80 FR 31145) and as described above, we decline to add family 
planning providers to the list of providers that would be subject to 
time and distance standards in Sec.  438.68; however, in light of these 
public comments and additional comments received in Sec.  438.206, we 
have provided additional discussion on the availability of family 
planning services at I.B.6.a.3.
    Comment: Several commenters recommended that CMS add the full range 
of pediatric providers to the provider-specific network adequacy 
standards at Sec.  438.68(b)(1). Specifically, commenters recommended 
that CMS add pediatric specialty pharmacies, pediatric specialty 
hospitals, pediatric medical subspecialists, pediatric surgical 
specialists, and pediatric dental specialists. One commenter 
recommended that CMS add age categories to the specific list of 
provider types. One commenter also recommended that CMS define 
``pediatric dental'' at Sec.  438.68(b)(1)(vii).
    Response: We understand the concerns underlying the recommendation 
to develop the full range of pediatric network adequacy standards; 
however, we decline to add these specialty providers to the list. While 
we understand the need to ensure access to care for pediatric 
populations, we believe it would be difficult for states to set an 
appropriate standard for these specialty providers. States can use the 
``specialist'' category to define pediatric specialists and 
subspecialists for which the state believes it is appropriate to set 
specific network adequacy standards. We also decline to add age 
categories to the specific list of provider types. We believe this 
would be difficult for states to operationalize and present additional 
barriers for states in setting appropriate and meaningful network 
adequacy standards. We also decline to define ``pediatric dental'' at 
Sec.  438.68(b)(1)(vii). We do not believe it is necessary to define 
this provider type category at the federal level, as we believe that 
states understand which dental providers provide services to their 
pediatric populations.
    Comment: Several commenters recommended that CMS add requirements 
at Sec.  438.68(b)(1) for states to specifically set network adequacy 
standards for provider types and specialists for which the state has a 
known workforce shortage.
    Response: We appreciate the recommendation to add requirements for 
states to specifically set network adequacy standards for provider 
types and specialists for which the state has a known workforce 
shortage; however, we decline to add such requirements. We believe it 
is inappropriate to add federal requirements on such a state-specific 
issue. States will be in the best position to make this decision and 
add network adequacy standards as appropriate. Our regulation on this 
point--the obligation of the state to establish time and distance 
standards--establishes the minimum that a state must do; states are 
able, and encouraged, to set additional standards consistent with the 
needs of their programs.
    Comment: Several commenters recommended that CMS add requirements 
at Sec.  438.68(b)(1) for states to set network adequacy standards for 
essential community providers (ECPs). One commenter also recommended 
that CMS add requirements for states to set network adequacy standards 
for all providers that provide essential health benefits (EHBs).
    Response: The Affordable Care Act created an ECP requirement for 
QHPs to ensure that those specific private plans were providing 
adequate access to care for low-income and medically underserved 
individuals and populations, who were likely to be enrolled in QHPs 
upon gaining access to coverage and in light of the federal financial 
assistance for those plans. The Medicaid program has a long history 
with ECPs, and we believe that most Medicaid managed care plans 
contract with ECPs on a regular basis. In addition, Medicaid has 
different statutory authorities that treat some ECPs differently than 
the private market, which drives variations in provider network supply 
and demand. Therefore, we find the requirement to add specific access 
standards for ECPs in the Medicaid program to be duplicative and 
unnecessary. We also decline to add all providers that provide EHBs. We 
believe this requirement is unnecessary, as the current list of 
provider types includes providers that would render such services.
    Comment: Several commenters recommended that CMS include both 
``adult and pediatric'' behavioral health at Sec.  438.68(b)(1)(iii) to 
account for varying standards in care, provider training, access to 
care issues, and population dynamics. One commenter recommended that 
CMS not include both ``adult and pediatric'' behavioral health, as it 
would be challenging for states to set meaningful standards.
    Response: We agree with commenters that it is important to include 
both adult and pediatric behavioral health in a state's network 
adequacy standards. This is consistent with the requirement of separate 
pediatric providers associated with physical health. We are modifying 
the regulatory text at Sec.  438.68(b)(1)(iii) to adopt this 
recommendation.
    Comment: Many commenters recommended that CMS clarify that the 
``behavioral health'' provider type/category at Sec.  438.68(b)(1)(iii) 
includes both mental health (MH) and substance use disorder (SUD) 
providers.
    Response: We agree with commenters that our language at Sec.  
438.68(b)(1)(iii) could be strengthened to specify that ``behavioral 
health'' includes both MH and SUD provider types. We are modifying the 
regulatory text to adopt this recommendation and clarify that 
behavioral health includes both MH and SUD in Sec.  438.68(b)(1)(iii).
    Comment: Many commenters recommended that CMS define the 
``specialist'' category at Sec.  438.68(b)(1)(iv). Several commenters 
recommended specific specialists for CMS to add. A few commenters 
recommended that CMS delete this language in its entirety, as the 
category would be too broad and unmanageable for states to set 
appropriate and meaningful network adequacy standards. One commenter 
recommended that CMS clarify that

[[Page 27661]]

states only set network adequacy standards for high-volume specialists. 
A few commenters recommended that CMS clarify that states can define 
the ``specialist'' category and set network adequacy standards that are 
appropriate at the state level.
    Response: We agree with commenters that states should define this 
category and set network adequacy standards that are appropriate at the 
state level. We believe that allowing states to define the 
``specialist'' category better reflects the needs of their respective 
programs, and we believe it would be inappropriate for CMS to define 
this standard at the federal level. We also believe that states are in 
the best position to engage a variety of stakeholders when defining the 
``specialist'' category and setting appropriate network adequacy 
standards for such defined ``specialist'' providers. We specifically 
encourage states to be transparent in this process.
    Comment: A few commenters recommended that CMS remove ``pharmacy'' 
at Sec.  438.68(b)(1)(vi) as a provider type. Commenters stated that 
managed care plans and states should have the flexibility to work with 
their pharmacy benefit managers (PBMs) to define pharmacy networks.
    Response: We thank commenters for their recommendation but decline 
to remove ``pharmacy'' at Sec.  438.68(b)(1)(vi). We understand the 
need for managed care plans and states to have flexibility, but we 
believe that access to pharmacies is a critical aspect of care for many 
beneficiaries. Some beneficiaries have limited access to 
transportation, and we believe it is important to have network adequacy 
standards to ensure appropriate access to care in this area.
    Comment: Many commenters supported proposed Sec.  438.68(b)(1), 
requiring states to develop time and distance standards for specific 
provider types. While many commenters supported time and distance 
standards, many other commenters did not believe that proposed Sec.  
438.68(b)(1) went far enough. Many commenters recommended that CMS 
include other network adequacy standards in addition to time and 
distance. Commenters recommended that CMS add provider to enrollee 
ratios, appointment and office wait times, beneficiary complaint 
tracking, and other network adequacy standards. Several commenters 
recommended that CMS not include a proposal for states to develop time 
and distance standards and instead allow states to adopt alternative 
network adequacy standards that are more appropriate for the scope of 
their program and populations covered. A few commenters also 
recommended that states be allowed to adopt ``reasonable access'' 
standards similar to those in the state and federal marketplaces.
    Response: We thank commenters for their support of proposed Sec.  
438.68(b)(1). We decline to add additional network adequacy standards 
in addition to time and distance. We believe that the regulation 
strikes the appropriate balance among the goals of avoiding overly 
prescriptive federal requirements, ensuring standards that ensure 
access to care, and permitting state flexibility. States will have the 
authority to add additional network adequacy standards if they choose. 
Many states have additional network adequacy standards, such as 
provider to enrollee ratios, and timely access standards such as 
appointment and office wait times. This proposed provision will still 
allow states to establish those network adequacy standards in their 
managed care contracts. It is for these same reasons that we decline to 
remove time and distance standards as a requirement in Sec.  
438.68(b)(1) or allow states to only adopt a ``reasonable access'' 
standard similar to the state and federal Marketplaces. While we 
understand the need for states to have adequate flexibility, we also 
believe that the flexibility must be subject to some national 
requirements; requiring that states establish and use time and distance 
standards is a minimal way for us to ensure access to care for Medicaid 
managed care beneficiaries.
    Comment: Many commenters recommended that CMS set quantitative time 
and distance standards in Sec.  438.68(b)(1). Several commenters also 
recommended that CMS set quantitative standards for provider to 
enrollee ratios, appointment and office wait times, and other 
quantitative standards. Several commenters recommended that CMS adopt 
MA's quantitative standards or set quantitative standards that are as 
stringent as MA. One commenter stated concern regarding the possibility 
of redundancies and duplications between Medicare and Medicaid network 
adequacy standards, if the managed care plan is serving dually eligible 
enrollees.
    Response: We appreciate the recommendations regarding proposed 
Sec.  438.68(b)(1); however, we decline to adopt quantitative standards 
for time and distance, provider to enrollee ratios, appointment and 
office wait times, or other quantitative standards. We believe that 
states should be allowed to set appropriate and meaningful quantitative 
standards for their respective programs. We also believe that states 
are in the best position to set specific quantitative standards that 
reflect the scope of their programs, the populations served, and the 
unique demographics and characteristics of each state. As many 
commenters stated, it is crucial for CMS to strike an appropriate 
balance between prescriptive federal standards and state flexibility. 
We also decline to adopt MA's network adequacy standards or 
quantitative standards that are as stringent as MA. Consistent with our 
role in the Medicaid managed care context compared to our role in the 
MA context, we do not believe it is appropriate to prescribe MA's 
network adequacy standards on state programs. Additionally, given the 
differences in the Medicaid and MA populations, it is unclear if such 
standards would be appropriate. Finally, it is unclear to us how the 
network adequacy standards finalized in this rule would be redundant or 
duplicative of Medicare standards. If a managed care plan operates in 
both Medicare and Medicaid markets and is serving dually eligible 
enrollees, Medicare's network adequacy standards would apply.
    Comment: A few commenters recommended that CMS add requirements at 
Sec.  438.68(b)(1) for states to specifically track the percentage of 
care provided out-of-network and set specific quantitative limits. A 
few commenters also recommended that CMS add additional requirements 
for states to set specific benchmarks for HEDIS measures as a proxy 
measure for network adequacy.
    Response: We thank commenters for the recommendation to add these 
requirements at Sec.  438.68(b)(1); however, we decline to do so. While 
we believe that such standards could be beneficial, it would be 
inappropriate to set a national requirement in these areas. States will 
have the flexibility to innovate in these areas and add network 
adequacy requirements as appropriate for their respective programs. We 
believe it is best to not be overly prescriptive regarding specific 
quantitative network adequacy standards and give states the flexibility 
to build upon the required time and distance standards as they deem 
appropriate and meaningful for their programs and populations.
    Comment: Many commenters recommended that CMS clarify that states 
can vary their time and distance standards by provider type. Several 
commenters also recommended that CMS clarify that states can implement 
additional network adequacy standards in addition to the time and 
distance standards required at Sec.  438.68(b)(1).

[[Page 27662]]

    Response: We clarify that states are not required to set the same 
network adequacy standards across all provider types and can vary such 
standards based on appropriate state benchmarks. We also clarify that 
states will have the authority to add additional network adequacy 
standards if they choose in addition to the required time and distance 
standards.
    Comment: A few commenters recommended that CMS allow for 
alternative network adequacy standards when beneficiaries are enrolled 
in integrated care models.
    Response: The network adequacy requirements at Sec.  438.68(b)(1) 
require that states establish, at a minimum, time and distance 
standards for MCOs, PIHPs, and PAHPs. States operating integrated care 
models that do not fall into one of those arrangements would not be 
bound by this section or 42 CFR part 438 generally.
    Comment: Several commenters recommended that CMS clarify that 
states should set specific quantitative time and distance standards for 
both adult and pediatric populations to meet the requirements at Sec.  
438.68(b)(1).
    Response: States must develop quantitative time and distance 
standards for both adult and pediatric provider types under Sec.  
438.68(b)(1)(i), (iii), and (iv). States must also develop quantitative 
time and distance standards for pediatric dental providers under Sec.  
438.68(b)(1)(vii).
    Comment: Several commenters recommended that CMS include 
requirements at Sec.  438.68(b)(1) to include secret shopper standards 
and benchmarks. A few commenters also recommended that CMS require 
specific patient satisfaction standards.
    Response: We thank commenters for the recommendation to add these 
requirements to Sec.  438.68(b)(1); however, we decline to do so. While 
secret shopper and patient satisfaction standards may be beneficial, we 
are unclear if such standards and requirements are an appropriate and 
meaningful national standard monitoring for network adequacy across all 
states and populations. We believe that such standards should be 
considered at the state level and would encourage states to continue 
exploring innovative and meaningful standards that ensure access to 
care for Medicaid beneficiaries.
    Comment: One commenter recommended that CMS include public notice 
and public comment requirements at Sec.  438.68(b)(1). The commenter 
recommended that CMS ensure that states are transparent when setting 
their specific network adequacy standards, including quantitative time 
and distance standards.
    Response: We believe that transparency is critical to Medicaid 
beneficiaries and proposed in Sec.  438.68(e) that states publish their 
network adequacy standards on a public Web site. We also encourage 
states to include appropriate and meaningful stakeholder engagement and 
feedback when setting their network adequacy standards. States should 
be using their already established public notice and public comment 
mechanisms and processes when promulgating future rules and 
requirements to comply with these standards.
    Comment: A few commenters recommended that CMS adopt TRICARE 
network adequacy standards, particularly at Sec.  438.68(b)(1)(vi), for 
pharmacy providers.
    Response: We appreciate the recommendation to adopt TRICARE network 
adequacy standards at Sec.  438.68(b)(1)(vi); however we decline to 
adopt this recommendation. We believe it is unclear if such standards 
would be appropriate for the Medicaid managed care program, given the 
differences between the TRICARE and Medicaid populations. We reiterate 
that states will have the authority and flexibility to set the specific 
quantitative time and distance standards for the list of provider types 
at Sec.  438.68(b)(1)(i) through (vii).
    Comment: Many commenters supported Sec.  438.68(b)(3) that would 
require states to establish network adequacy standards for all 
geographic areas covered by the managed care program or contract. 
Several commenters also supported permitting states to have varying 
network adequacy standards for the same provider type based on 
geographic areas. A few commenters recommended that CMS clarify this 
language and define specific criteria for standards that vary based on 
geographic area. A few commenters did not support permitting states to 
vary their network adequacy standards based on geographic areas, as 
this flexibility would allow states to set different standards in rural 
areas and might disadvantage beneficiaries living in rural communities. 
Finally, several commenters recommended that CMS clarify that states 
have the flexibility to set varying network adequacy standards across 
rural and urban population centers.
    Response: We thank commenters for the support and recommendations 
regarding Sec.  438.68(b)(3). We clarify that states do have the 
flexibility to set varying network adequacy standards across rural and 
urban population centers, because this is the same as allowing states 
to have varying network adequacy standards for the same provider type 
based on geographic areas. States are not required to set the same 
network adequacy standards across all provider types for the entire 
state and can vary such standards based on appropriate state 
benchmarks. We decline to define specific criteria for network adequacy 
standards that vary based on geographic area, as we believe this would 
be inappropriate for CMS to define at a federal level. States are in 
the best position to define these criteria, as they have a unique 
understanding of their state's communities and geography. We also 
disagree with commenters that believe this flexibility will 
disadvantage beneficiaries living in rural communities. We believe it 
is appropriate for states to retain this flexibility, as states can set 
appropriate network adequacy standards that account for a rural 
community's population demographics and service needs.
    Comment: Many commenters supported Sec.  438.68(c)(1), requiring 
that states consider a minimum list of elements when developing their 
network adequacy standards. Many commenters specifically supported 
Sec.  438.68(c)(1)(vii) and (viii), requiring that states consider LEP 
enrollees, physical access, reasonable accommodations, cultural 
competency, and accessibility for enrollees with physical or mental 
disabilities. Several commenters requested that CMS include specific 
standards and thresholds for states to include, such as ensuring that 
network adequacy standards consider the top 15 languages of enrollees 
in a particular area, or ensuring that network adequacy standards 
consider any language that is spoken or written by at least 5 percent 
of enrollees (or at least 500 enrollees). A few commenters recommended 
that CMS remove the LEP and access language at Sec.  438.68(c)(1)(vii) 
and (viii), concerned that such requirements would be harmful and 
burdensome to smaller providers.
    Response: We thank commenters for the support and recommendations 
regarding Sec.  438.68(c)(1)(vii) and (viii). We believe that states 
should consider LEP enrollees, physical access, reasonable 
accommodations, cultural competency, and accessibility for enrollees 
with physical or mental disabilities when developing their network 
adequacy standards. We also encourage states to work with a variety of 
stakeholders to ensure that such standards are adequate to ensure 
access to care for Medicaid's vulnerable populations. We do decline to 
set

[[Page 27663]]

specific standards and thresholds in this area, as we believe it is 
most appropriate for states to assess their populations and set 
thresholds and standards accordingly. We also decline to remove such 
elements from what states must consider when developing access and 
adequacy standards, as we believe it is important to set a national 
framework that guides states in the development of common network 
adequacy standards.
    Comment: Many commenters supported Sec.  438.68(c)(1)(iii) and (vi) 
requiring states to consider the characteristics and health care needs 
of specific populations and the means of transportation ordinarily used 
by enrollees when setting their network adequacy standards. However, 
many commenters did not believe that CMS went far enough in prescribing 
these elements. Commenters recommended that CMS include specific 
criteria for enrollees that use public transportation. Other commenters 
recommended that CMS include specific criteria for enrollees with 
complex or chronic health conditions, such as children and special 
populations with special health care needs.
    Response: We thank commenters for the support and recommendations 
regarding Sec.  438.68(c)(1)(iii) and (vi). We believe it is important 
for states to consider these criteria when setting their network 
adequacy standards. We also restate our belief that it is important for 
states to work with their stakeholder community. We decline to set 
additional specific standards and thresholds that states must consider, 
as we believe it is inappropriate to prescribe a national benchmark 
when states are in the best position to understand the unique needs of 
their populations and can best set criteria and standards that are most 
meaningful to their respective programs. We instead have adopted a 
general national framework that we believe will guide states in the 
development of network adequacy standards that strengthen access to 
care for all Medicaid populations.
    Comment: Several commenters recommended that CMS include specific 
criteria at Sec.  438.68(c)(1) regarding provider panels, provider 
capacity, and the capacity of providers to provide both emergency and 
non-emergency care to enrollees.
    Response: We thank commenters for the recommendations at Sec.  
438.68(c)(1) to ensure that CMS has included criteria for network 
adequacy that is inclusive of provider panels, provider capacity, and 
the capacity of providers to provide both emergency and non-emergency 
care to enrollees. For provider panels and general provider capacity, 
we believe these elements are captured at Sec.  438.68(c)(1)(i), (ii), 
(iv), and (v). We have included elements specific to the anticipated 
Medicaid enrollment, expected utilization of services, the numbers and 
types of network providers, and the number of network providers not 
accepting new Medicaid patients. We believe these elements are 
inclusive of the commenters' recommendations and require states to 
consider and analyze provider panels and general provider capacity. For 
the capacity of network providers to provide both emergency and non-
emergency care to enrollees, we believe this recommendation is included 
at Sec.  438.68(c)(1)(iv) specifically. States must not only consider 
the numbers and types of network providers, but they must also consider 
their training, experience, and specialization. We believe this element 
will ensure that provider networks are capable of providing both 
emergency and non-emergency care.
    Comment: Many commenters recommended that CMS strengthen the 
language at Sec.  438.68(c)(1) and change the word ``consider'' to 
``factor'' or ``utilize.'' Commenters stated that they were concerned 
that the current language would not require states to demonstrate and 
support that they considered all of the elements when developing their 
network adequacy standards.
    Response: We believe that the current language is clear that states 
must consider, at a minimum, the elements listed in the regulation text 
when developing their network adequacy standards. We encourage states 
to be thorough in their approach when developing network adequacy 
standards. We also encourage states to work with a variety of 
stakeholders as they develop their network adequacy standards to ensure 
that such standards are representative of the program and populations 
at large.
    Comment: Several commenters recommended that CMS add elements at 
Sec.  438.68(c)(1) to include triage lines or screening systems, as 
well as the use of telemedicine, e-visits, and/or other evolving and 
innovative technological solutions. Commenters stated that such 
elements could impact the needs of enrollees in particular areas.
    Response: We agree with commenters that such services and 
technological solutions could impact the needs of enrollees in a 
particular area and could change the manner and extent to which other 
network providers are needed and utilized. We encourage states to 
consider how current and future technological solutions could impact 
their network adequacy standards. Therefore, we agree with adding these 
criteria to the list of elements that states should consider when 
developing network adequacy standards. We are modifying the regulatory 
text to adopt this recommendation at Sec.  438.68(c)(1)(ix).
    Comment: Many commenters supported proposed Sec.  438.68(d)(1), 
allowing states to provide an exception to any of the provider-specific 
network standards. A few commenters recommended that CMS be more 
prescriptive in this area and structure a detailed process for states 
to follow. A few commenters recommended that CMS make clear that states 
have full flexibility in designing and implementing exceptions 
criteria. Other commenters recommended that CMS not allow any 
exceptions under paragraph (d)(1) and remove the language in its 
entirety. Several commenters recommended that CMS strengthen the 
language to make clear that states are only permitted to grant 
exceptions in rare circumstances, such as when a managed care plan 
cannot possibly meet the network adequacy standard, or the standard is 
in regard to a rare medical condition. One commenter also recommended 
that CMS not allow exceptions to provider-specific network standards 
and instead enforce that states must allow such services on a FFS 
basis.
    Response: We thank commenters for their support and recommendations 
for proposed Sec.  438.68(d)(1). We believe that it is important for 
states to retain flexibility in this area, as states are in the best 
position to understand the unique provider characteristics and 
demographics in their respective programs. We also agree with 
commenters that exceptions should not be permitted lightly, and that 
states should only grant exceptions in rare circumstances. This is why 
we proposed Sec.  438.68(d)(2), which requires states to monitor access 
to care for any provider types that are permitted an exception, and 
that states must include their findings in the managed care program 
assessment report required at Sec.  438.66. We decline commenters' 
recommendations to never allow states to permit an exception, as we 
believe this is unrealistic. We cannot predict future provider 
workforce shortages and should not penalize states and managed care 
plans by removing their flexibility to seek and permit reasonable and 
appropriate provider-specific network exceptions. Finally, we also 
decline the recommendation to require that states must allow for 
services to be provided

[[Page 27664]]

through FFS rather than allow for any provider-specific exceptions. It 
is unclear to us that these concepts are related. Managed care plans 
are already required to offer services out-of-network, if they cannot 
provide covered services within the network.
    Comment: One commenter recommended that CMS add exemption criteria 
at Sec.  438.68(d)(1) for any managed care plan that has achieved and 
met accreditation standards for network adequacy.
    Response: We thank commenters for the recommendation at Sec.  
438.68(d)(1); however, we decline to add exemption criteria for any 
managed care plan that has achieved and met accreditation standards for 
network adequacy. We believe that this would be a broad exemption to 
Sec.  438.68 in whole, and we believe that is not consistent with our 
general approach in requiring network adequacy standards and ensuring 
access to care. Since it is impossible for us to account for all of the 
exact standards and thresholds that might lead a managed care plan to 
gain accreditation for network adequacy, we find it appropriate for 
states to require accredited managed care plans to also meet the 
network adequacy standards at Sec.  438.68.
    Comment: One commenter recommended that CMS add specific exceptions 
criteria at Sec.  438.68(d)(1) for MLTSS programs and providers.
    Response: We believe that the current language and criteria at 
Sec.  438.68(d)(1) is inclusive and sufficient for both non-MLTSS and 
MLTSS programs. We believe that the process that a state would follow 
to permit an exception would be the same for all programs and 
contracts.
    Comment: A few commenters recommended that CMS specifically approve 
all exceptions at Sec.  438.68(d)(1) before allowing states to permit 
the provider-specific network exception. A few commenters also 
recommended that CMS require strict documentation from the state to 
support the exception.
    Response: We understand that commenters are concerned with access 
to care, and CMS is committed to improving access to care through 
several mechanisms and processes, including network adequacy standards. 
This is why we proposed Sec.  438.68(d)(2), which requires states to 
monitor access to care for any provider types that are permitted an 
exception, and that states must include their findings in the managed 
care program assessment report required at Sec.  438.66. We believe 
that this is the appropriate mechanism and process for CMS to review 
and monitor both state-specific and provider-specific exceptions. 
Therefore, we decline to modify the regulation text as recommended by 
the commenters here.
    Comment: Many commenters supported proposed Sec.  438.68(e) 
requiring states to publish their network adequacy standards on the 
state public Web site. Several commenters also recommended that CMS 
publish these standards on a federal platform, such as Healthcare.gov 
or Medicaid.gov.
    Response: We thank commenters for their support and recommendations 
at Sec.  438.68(e). We do not believe that it is necessary for CMS to 
also post a state's network adequacy standards on Healthcare.gov or 
Medicaid.gov, as states are required to post their network adequacy 
standards on their own state public Web site. We believe this is more 
effective in facilitating discussions with the stakeholder community in 
that state.
    Comment: A few commenters recommended that CMS specifically approve 
a state's network adequacy standards at Sec.  438.68(e) and that CMS 
should publish a review of the state's network adequacy standards on 
the CMS public Web site for public comment.
    Response: Consistent with our general approach throughout Sec.  
438.68, we do not believe it is necessary for CMS to actively approve a 
state's network adequacy standards and publish our review on the CMS 
Web site. Throughout Sec.  438.68, we have provided an overarching 
federal framework for network adequacy standards that we hope will 
guide states toward the development of common network adequacy 
standards that improve access to care for all Medicaid beneficiaries. 
However, it is not our intention to prescribe exact quantitative 
standards or set a national floor for such standards, as we believe 
this approach to be overly prescriptive and does not allow for 
appropriate and meaningful state flexibility in their respective 
programs. We therefore decline to adopt the commenters' 
recommendations, as we do not believe it is possible for CMS to 
actively approve a state's network adequacy standards without 
prescriptive metrics. Instead, we encourage states to include 
appropriate and meaningful stakeholder engagement and feedback when 
setting their network adequacy standards, and we believe that requiring 
states to publish such standards on their state public Web site will 
enhance and improve transparency.
(2) Criteria for Developing Network Adequacy Standards for MLTSS 
Programs (Sec.  438.68(b)(2) and (c)(2))
    In the proposed rule, we proposed minimum standards for how states 
adopt network adequacy standards to ensure the availability of critical 
services and supports for beneficiaries as more of them transition to 
MLTSS programs. We noted that, unlike medical and behavioral health 
services, there are no commonly used access standards for LTSS in the 
private market or in Medicare, as LTSS are primarily covered through 
Medicaid. Further, as states have begun to deliver LTSS through managed 
care, they have created standards for their individual programs, which 
vary widely. Likewise, the level of oversight by the state that is 
necessary to enforce network adequacy standards for LTSS provided 
through managed care contracts varies, ranging from a minimal level of 
effort to an in-depth review of service plan authorizations compared to 
actual claims experience.
    We noted that LTSS can also be delivered in a person's home, a 
provider's office, in various community locations, such as places of 
employment or recreation, or in an institution. In Sec.  438.68(b)(2), 
we proposed that states would set standards that encompass time and 
distance and other measures of access when delivering LTSS through 
their managed care plans, noting that the type of standard that the 
state would adopt under our proposal depends on whether the enrollee or 
the provider must travel to provide the services. While we did not 
specify a specific set of providers in our LTSS-specific proposal, we 
indicated that we expect the state to consider all LTSS delivered 
through managed care when developing the standards which may include, 
but are not limited to, institutional, community-based, residential, 
and employment supports providers, depending on the program. Proposed 
paragraph (c)(2) set forth the elements that states would have to 
consider when developing standards for LTSS in a managed care program. 
Under our proposal, when developing time and distance standards, states 
would consider the same elements as when setting medical services 
network standards and also consider strategies to ensure the health and 
welfare of enrollees using LTSS and to support community integration of 
individuals receiving LTSS. We noted that LTSS enrollees may have 
different needs than those enrollees only using acute, primary, and 
behavioral health services. For example, assessing network

[[Page 27665]]

adequacy for individuals receiving LTSS in their place of residence may 
be based on enrollee-to-provider ratios. Additionally, the ability of 
the enrollee to choose a provider is a key protection that must be 
considered when developing network standards for MLTSS so we proposed 
to include that here. We also noted that supporting health and welfare 
and choice of provider are important tenets already in place in the 
LTSS FFS system and MLTSS should maintain those protections. Finally, 
our proposal included a substantive standard which we would apply to 
determine if states must include other considerations under Sec.  
438.68(c)(2)(iv).
    We received the following comments in response to our proposal to 
add new Sec.  438.68(b)(2) and (c)(2).
    Comment: One commenter thought states should have full discretion 
and there should not be any defined network adequacy standards for 
MLTSS; all other commenters recommended the adoption of some form of 
standards for LTSS. Many commenters stated that time and distance 
standards were appropriate for LTSS services where the individual must 
travel to a provider, although a few commenters added that beneficiary 
disability and transportation considerations need to factor in to the 
time and distance standards. Several commenters thought CMS should 
establish how much time and what distance the states must adopt as the 
standard, and several others commented that CMS should set a baseline 
requirement upon which states could develop their full network adequacy 
standards. One commenter thought CMS should convene a technical expert 
panel to establish national network adequacy standards for LTSS; a 
couple of commenters asked for a workgroup to study the issue; and one 
other proposed that residential providers would not need to have time 
and distance network adequacy standards.
    Response: We thank commenters for their support for the use of time 
and distance standards for LTSS services where the member travels to 
the provider for services. Section 438.68(c)(2) specifies 
considerations that must be taken into account in establishing LTSS 
network adequacy standards including other considerations that are in 
the best interest of the enrollees who need LTSS. We believe this 
language is sufficiently broad to ensure consideration of the needs of 
the LTSS population. Although we had requested further comment in the 
area of network adequacy standards for LTSS, no respondent provided 
specific time or distance standards that have been used or that have 
proven adequate to assure network adequacy. For these reasons, we 
continue to believe that, at this time, the best strategy is for states 
to develop their own time and distance standards for LTSS provider 
types to which a beneficiary travels, based on the state's unique 
service, beneficiary and geographic considerations.
    Comment: Several commenters addressed network adequacy standards 
for LTSS providers that travel to the individual's home. A couple of 
commenters suggested that provider ratios were not a satisfactory 
measure, while others recommended using direct care provider ratios to 
LTSS beneficiary service plan hours. Additionally, a few commenters 
recommended adopting time and distance standards even when the provider 
travels to the member. A few commenters addressed network adequacy 
standards for LTSS where providers travel to the enrollee and there was 
no clear consensus for one type of measure over another.
    Response: We believe that the few number of comments and lack of 
consensus regarding the measure of network adequacy for services when a 
provider travels to the enrollee confirm our position that states 
should establish standards based on their unique mix of services and 
characteristics and evaluate and amend these standards, as appropriate. 
A ratio of direct provider capacity to treatment or service plan hours 
may inform the development of network adequacy standards, but there are 
circumstances, such as self-directed services, where this analysis may 
not be possible. Therefore, we are finalizing our standards in 
paragraph (b)(2) as proposed in this final rule.
    Comment: Some commenters suggested that there are multiple entities 
that should be involved in establishing network adequacy standards for 
LTSS. A few commenters believed that states, managed care plans, and 
counties should work together to develop standards; another commenter 
thought providers should participate in establishing standards; and a 
number of commenters thought beneficiaries should participate in 
establishing the network adequacy standards.
    Response: We support the inclusion of stakeholders in the 
development of network adequacy standards at the state level but 
decline to specify the nature the development process in regulation 
beyond what is required by Sec.  438.68(c) in this final rule. As each 
state is responsible for assuring that their managed care Medicaid 
beneficiaries have access to covered and necessary services at Sec.  
438.207, we believe the state must be the entity responsible for 
establishing the network adequacy standards. Per Sec.  438.68(e), the 
network adequacy standards will be available on the state's Web site.
    Comment: Several commenters requested that beneficiary choice of 
LTSS provider be factored into network adequacy standards. A couple of 
commenters thought LTSS network adequacy standards should consider wait 
times, provider availability in a region, and the provider type. 
Several commenters pointed out that LTSS provider credentialing 
standards are important to consider; some commenters stated that 
incentives be provided to managed care plans who meet the state LTSS 
network adequacy standards; and one commenter suggested that 
beneficiaries should have access to out of network LTSS providers 
whenever timely access is denied. One commenter suggested that managed 
care plans should be required to provide recruitment and retention 
bonuses to LTSS providers. One commenter believed that there are not 
enough LTSS providers available in general to meet demand. A number of 
commenters recommended that states should be required to report to CMS 
on enrollee outcomes after LTSS network adequacy standards have been 
implemented. A few commenters suggested that periodic audits should be 
conducted by states and provided to the public on network adequacy.
    Response: We appreciate the commenters' concerns and thank 
commenters for the many suggestions. We agree with the commenters that 
beneficiary choice of provider be factored into network adequacy 
standards. Enrollee choice of provider is a factor for consideration in 
Sec.  438.68(c)(2)(ii). We believe that the language is sufficient to 
require states to consider enrollee choice, without being overly 
prescriptive on how it should be considered.
    CMS also agrees with commenters that timely access and availability 
of services is critical for all enrollees and especially for enrollees 
needing LTSS. Section 438.207(d) requires managed care plans to 
document and provide assurance that they are meeting the state's 
requirements for the availability of services as set forth in Sec.  
438.206. States are required to review this documentation and submit an 
assurance to CMS that managed care plans are meeting the state's 
requirements for the availability of services. We decline to add 
requirements because states need flexibility to tailor their program to 
the populations served and the benefits provided.

[[Page 27666]]

    We also decline to require additional reporting on the network 
adequacy requirements. Section 438.207(d) requires that documentation 
and analysis be submitted to CMS. Likewise, Sec.  438.66(e)(2)(vi) 
requires states to report on the availability and accessibility of 
services in the annual report. We believe that these two requirements 
provide an appropriate balance between CMS oversight role, public 
transparency, and administrative burden on states.
    Comment: Several commenters thought there should be separate 
network adequacy standards for pediatric LTSS providers, and several 
thought geographical considerations must be taken into account.
    Response: We agree that if pediatric LTSS providers offer necessary 
services that an adult LTSS provider cannot appropriately provide, 
states should consider the most appropriate way to address these 
providers in the network adequacy standards. However, we decline to 
include any specific type of LTSS provider in the regulations. We 
believe that states are in the best position to determine the providers 
to include to best meet the needs of the LTSS program. We agree with 
the commenters that geographical considerations are an important 
consideration in developing network adequacy standards. As proposed and 
finalized here, Sec.  438.68(c)(1)(vi) requires states to consider 
geographic factors and Sec.  438.68(b)(3) permits states to vary 
standards for the same provider type based on geographical area. We 
believe that these sections address the commenters' concerns.
    After consideration of the public comments, we are modifying the 
regulatory text at Sec.  438.68(b)(1)(iii) to include both ``adult and 
pediatric'' behavioral health. We are also modifying the regulatory 
text at Sec.  438.68(b)(1)(iii) to clarify that the ``behavioral 
health'' provider type/category includes both mental health (MH) and 
substance use disorder (SUD) providers. We are finalizing the 
regulation text at paragraphs (c)(1)(vi) through (viii) to use 
``network provider'' in place of the proposed use of ``health care 
professionals'' for reasons discussed in section I.B.9.a. of this final 
rule. We are modifying the regulatory text at Sec.  438.68(c)(1)(ix) to 
include triage lines or screening systems, as well as the use of 
telemedicine, e-visits, and/or other evolving and innovative 
technological solutions, as criteria that states should consider when 
setting their network adequacy standards and, to account for this 
additional text in the final rule, are modifying paragraph (c)(2)(i) to 
refer to paragraphs (c)(1)(i) through (ix). We are finalizing all other 
paragraphs in Sec.  438.68 as proposed.
(3) Availability of Services (Sec.  438.206 and Sec.  440.262)
    Currently, in Sec.  438.206, states must ensure that all services 
covered under the state plan are available and accessible to enrollees 
of MCOs, PIHPs, and PAHPs. Throughout Sec.  438.206, we proposed to use 
the terms ``network provider'' and ``provider'' as applicable to be 
consistent with the proposed new definitions of these terms (see 
section I.B.9. of this final rule) and to provide greater clarity to 
our regulations. We consider such changes largely technical in nature.
    We also proposed to revise paragraph (a), which currently sets 
forth the basic rule for the availability of services, to add a new 
sentence such that states must ensure that MCO, PIHP, and PAHP provider 
networks for services covered under the MCO, PIHP, or PAHP contract 
meet the state's network adequacy standards established under proposed 
Sec.  438.68. In addition, we also proposed to clarify that services 
are to be made available and accessible in a timely manner. The 
timeliness standard is currently in paragraph (b)(4), pertaining to 
access to out-of-network providers, and in paragraph (c)(1); we 
indicated that we believe it is appropriate to incorporate timeliness 
into the general rule for availability of services in paragraph (a).
    In paragraph (b), we proposed substantive changes only to (b)(1) 
and (b)(5). We proposed to move the second sentence of (b)(1) and the 
provisions at existing paragraphs (b)(1)(i) through (b)(1)(v) to the 
new Sec.  438.68(c) so that all regulatory standards related to the 
measurement of adequate MCO, PIHP, and PAHP provider networks are 
contained in one section. We proposed to add text to (b)(1) to clarify 
that the sufficiency and adequacy of the provider network and access to 
services is for all enrollees, including those with limited English 
proficiency and physical or mental disabilities. We proposed to amend 
paragraph (b)(5) to include PAHPs in the payment standard for covered 
services that are provided out-of-network. We stated that this 
represents a technical correction as the preamble for the 2002 final 
rule refers to PAHPs (67 FR 41038) and we believe PAHPs were 
inadvertently excluded from the final regulatory text.
    We did not propose any substantive changes to existing paragraph 
(c)(1) but proposed changes to improve the readability and clarity of 
the regulation text. We also clarified our intent to interpret and 
apply the provisions in paragraph (c)(1) as requiring states to set 
standards for timely access to all state plan services covered under 
the managed care contract. For purposes of setting timely access 
standards, state plan services may be reasonably classified as routine, 
urgent, or emergency care. We noted that for access standards to be 
effective, states will need to have mechanisms in place for ensuring 
that those standards are being met by the managed care plan networks. 
We considered requiring a mix of approaches, such as conducting 
enrollee surveys, reviewing encounter data, calculating and reporting 
of HEDIS measures related to access, implementing secret shopper 
efforts, and a systematic evaluation of consumer service calls. We 
requested comment on approaches to measuring enrollee's timely access 
to covered services and to evaluating whether managed care plan 
networks are compliant with such standards. We also requested comment 
on the value of requiring some or all of these mechanisms for ensuring 
that access standards are being met.
    In paragraph (c)(2), we proposed to add to the standards to ensure 
that MCOs, PIHPs, and PAHPs participate in states' efforts to promote 
access in a culturally competent manner to all enrollees. This includes 
those with limited English proficiency, diverse cultural and ethnic 
background, disabilities, and regardless of an enrollee's gender, 
sexual orientation, or gender identity. We also proposed to add a 
corresponding standard in a new Sec.  440.262 so that the state would 
similarly ensure cultural competence and non-discrimination in access 
to services under FFS. We believe that the obligation for the state 
plan to promote access and delivery of services without discrimination 
is necessary to assure that care and services are provided in a manner 
consistent with the best interest of beneficiaries under section 
1902(a)(19) of the Act. We noted that the best interest of 
beneficiaries is appropriately met when access is provided in a non-
discriminatory manner; adopting these additional methods of 
administration is also necessary for the proper operation of the state 
plan under section 1902(a)(4) of the Act.
    We proposed to add a new paragraph (c)(3) to emphasize the 
importance of network providers having the capabilities to ensure 
physical access, accommodations, and accessible equipment for the 
furnishing of services to Medicaid enrollees with physical or mental 
disabilities. We noted that this proposal was mirrored in proposed

[[Page 27667]]

Sec.  438.68(c)(1)(vii) relating to considerations for developing 
network adequacy standards.
    We received the following comments in response to our proposal to 
revise Sec.  438.206 and add new Sec.  440.262.
    Comment: Many commenters supported Sec.  438.206(a). A few 
commenters recommended additional regulatory text to clarify that 
specific state plan services must be made available by managed care 
plans.
    Response: We thank commenters for their support of Sec.  
438.206(a). We disagree with commenters that we should add regulatory 
text to clarify that specific state plan services must be made 
available by managed care plans. We believe the current regulatory text 
is clear that all services covered under the state plan must be 
available and accessible to enrollees of managed care plans. States are 
free to design the methods of delivery of those services to eligible 
beneficiaries.
    Comment: Many commenters supported Sec.  438.206(b)(1). Several 
commenters recommended that CMS include specific references to 
Sec. Sec.  438.2 and 438.3 regarding contract requirements. Several 
commenters also recommended that CMS include a specific reference to 
Sec.  438.68(c) regarding network adequacy standards.
    Response: We disagree with commenters that we should include 
specific references at Sec.  438.206(b)(1) to include Sec. Sec.  438.2, 
438.3, and 438.68(c), as we find these references to be duplicative and 
unnecessary. All managed care contracts must comply with the standard 
contract requirements at Sec.  438.3. We proposed in Sec.  438.206(a) 
that all services covered under the managed care contract must meet the 
standards developed by the state in accordance with Sec.  438.68. It is 
unclear why commenters have recommended that we include a reference to 
Sec.  438.2, as this is in the definitions section of part 438; we 
therefore decline to add such a reference, as the definitions apply to 
all sections contained in this part.
    Comment: Many commenters recommended revisions or clarifications at 
Sec.  438.206(b)(2) regarding direct access to a women's health 
specialist. Many commenters recommended that CMS clarify that this 
requirement also applies to adolescent women who are under the age of 
18 but still require the services of a women's health specialist. Many 
commenters recommended that CMS remove the language ``routine and 
preventive'' as they believe that managed care plans use this language 
to exclude direct access to specialty health care services for women. 
Many commenters also recommended that CMS add language to clarify that 
specialty health care services for women are included in the direct 
access requirement. Several commenters recommended that CMS define 
``routine and preventive'' health care services for women, and a few 
commenters recommended that CMS list all women's routine and preventive 
health care services that are included in the direct access 
requirement. Several commenters recommended that CMS add language to 
clarify that if either the managed care plan or provider has religious 
objections to specific health care services for women, such health care 
services must be allowed out of network and without cost to the 
enrollee. Finally, many commenters recommended that CMS add regulatory 
text to clarify that direct access for all family planning providers 
(both in and out of network), services, and supplies must be allowed 
for all enrollees, regardless of age, sex, or gender, if such enrollees 
can be considered to be sexually active, consistent with the 
requirements at sections 1902(a)(23) and 1905(a)(4)(C) of the Act.
    Response: We appreciate commenters' recommendations at Sec.  
438.206(b)(2). A managed care plan is required to provide female 
enrollees with direct access to a women's health specialist within the 
network for routine and preventive health care services. This includes 
initial and follow-up visits for services unique to women such as 
prenatal care, mammograms, pap smears, and for services to treat 
genitourinary conditions such as vaginal and urinary tract infections 
and sexually transmitted diseases. Further, we use the term ``female 
enrollees'' to include minor females. We believe that if there is a 
medical need to see a women's health specialist, there should be no 
impediment based on the age of the enrolled female. However, we 
disagree with commenters that regulatory text revisions are necessary 
and instead believe that our clarification above is sufficient to 
remove any further ambiguity regarding the age of a female enrollee and 
the context of ``routine and preventive'' health care services for 
women.
    We also disagree with commenters that we should add language 
regarding out of network access to care for services not provided by a 
managed care plan due to religious objections. Within part 438, we have 
included references for religious objections at Sec.  
438.10(e)(2)(v)(C), Sec.  438.10(g)(2)(ii)(A) and (B), and Sec.  
438.100(b)(2)(iii). Consistent with the context of the regulatory text, 
Sec.  438.206(b)(2) is related to the availability of services within 
the managed care plan's delivery network. It is not appropriate to add 
regulatory text to address all circumstances that could warrant out of 
network care or services, including religious objections.
    Comment: In addition to comments regarding the availability of 
family planning services, we also received comments in response to our 
request for comment in Sec.  438.68 as to whether family planning 
should be included in the network adequacy provisions. The comments 
received on family planning indicate that, while network adequacy 
standards may not be needed due to enrollees' ability to access 
services out of network, some clarification on states' and managed care 
plans' responsibility for ensuring the availability of these services 
would be helpful.
    Response: We agree with commenters that the statutory protections 
for family planning services should be reflected in part 438 
regulations. We included, in the proposed rule and this final rule, the 
references for family planning services and supplies being available at 
Sec. Sec.  438.10(g)(2)(vii) and 438.210(a)(4)(ii)(C) to be consistent 
with the statutory requirements in sections 1902(a)(23)(B) and 
1905(a)(4)(C) of the Act. We are also finalizing additional text in 
section 438.10(g)(2)(vii) to specify that enrollees cannot be required 
to obtain a referral prior to choosing their family planning provider.
    In Sec.  438.206, we have added a new paragraph (b)(7) that 
requires states to include a contract provision in all MCO, PIHP, and 
PAHP contracts requiring the managed care plan to demonstrate that it 
has sufficient providers for family planning services in network to 
provide timely access. Despite the ability of enrollees to access 
family planning services out of network without a referral, we agree 
with commenters that it is important for managed care plans to be able 
to provide sufficient timely access to these services within the 
network as well. Use of network providers facilitates claims payment, 
helps enrollees locate providers more easily, and improves care 
coordination. While the ability to choose a family planning provider 
from outside a managed care plan's network is an important beneficiary 
option, we do not believe it negates the managed care plan's 
responsibility to ensure timely access within its network. For these 
reasons, we are finalizing new paragraph (b)(7).
    Comment: Several commenters supported Sec.  438.206(b)(3). One 
commenter recommended that CMS add the term ``timely'' to ensure that 
second opinions are obtained in a timely

[[Page 27668]]

manner. One commenter recommended that CMS add ``internists'' as 
specific health care professionals that could be consulted when a 
second opinion is needed.
    Response: We agree with commenters that timely access to a second 
opinion is important to ensure timely access to care; however, we 
decline to add the term ``timely'' at Sec.  438.206(b)(3), as timely 
access is considered at Sec.  438.206(c)(1). We further decline to add 
``internists'' as specific network providers that could be consulted 
when a second opinion is needed, as it is not consistent with the 
general approach of the regulatory text to allow a second opinion from 
any qualified network provider. We are finalizing the regulation text 
at Sec.  438.206(b)(3) to use ``network provider'' in place of the 
proposed use of ``health care professional'' for reasons discussed in 
section I.B.9.a. of this final rule.
    Comment: Many commenters recommended revisions or clarifications at 
Sec.  438.206(b)(4) regarding out of network services and benefits for 
enrollees. Many commenters recommended that CMS specifically include 
language to clarify that if the provider network is unable to provide 
necessary specialty services or specialty care, managed care plans must 
cover such services out of network. A few commenters also recommended 
that CMS add specific language for out of network services for rare 
conditions and provider shortages. One commenter recommended that CMS 
allow direct access to HIV specialists. Many commenters recommended 
that CMS add the term ``timely'' and specifically reference the time 
and distance standards at Sec.  438.68 and the assurances of adequate 
capacity and services at Sec.  438.207(b) and (c). One commenter 
recommended that CMS add requirements to ensure that if managed care 
plans must arrange for out of network services, the managed care plan 
must cover the cost of the care and must provide transportation for the 
enrollee. One commenter recommended that CMS clarify that Sec.  
438.206(b)(4) does not require states to offer out of network benefits 
unless the managed care plan does not have contracted providers to meet 
the needs of enrolled populations, and the provision does not negate 
internal processes that must be followed by enrollees to obtain 
approval for out of network services.
    Response: We appreciate the thoroughness of commenters' 
recommendations at Sec.  438.206(b)(4). While we understand commenters' 
concerns regarding specialty services and care, rare conditions, 
provider shortages, and direct access to HIV specialists, we decline to 
add these specific circumstances to the regulatory text, as we believe 
such text would be duplicative and unnecessary. The current text 
requires managed care plans to adequately and timely cover services out 
of network for enrollees if their current provider networks are unable 
to provide the necessary services covered under the contract. We 
believe this text is inclusive of specialty services and all other 
circumstances when the provider network is unable to provide the 
necessary services needed for enrollees. We also decline to add 
specific references to Sec.  438.68 and Sec.  438.207(b) and (c), as we 
believe it is duplicative and unnecessary. We have already included the 
appropriate reference to Sec.  438.68 at Sec.  438.206(a). We decline 
to add the term ``timely,'' as timely access is required at Sec.  
438.206(c)(1). We also decline to add requirements that managed care 
plans must cover the cost of transportation, as NEMT is generally a 
covered benefit provided to enrollees, either through the managed care 
plan, or through other arrangements provided by the state. We also 
clarify that consistent with Sec.  438.206(b)(5), the cost to the 
enrollee for out of network services can be no greater than if the 
services were furnished within the network. Finally, we clarify for the 
commenter that out of network benefits are only required when the 
provider network is unable to provide the necessary services covered 
under the contract. We also note that the provisions at Sec.  
438.206(b)(4) do not negate internal state or managed care plan 
processes for enrollees to obtain approval for out of network services.
    Comment: Several commenters recommended that CMS add requirements 
at Sec.  438.206(b)(5) to set payment parameters for out of network 
providers. A few commenters recommended that CMS require managed care 
plans to pay FFS rates to out of network providers. One commenter 
recommended that CMS allow states to set a specific percentage of FFS 
that managed care plans must pay out of network providers. One 
commenter recommended that CMS allow states to incentivize single 
source contracts between managed care plans and out of network 
specialists.
    Response: We decline to adopt commenters' recommendations at Sec.  
438.206(b)(5), as we believe the issue of payment for out of network 
providers is between managed care plans and health care providers. Our 
regulation only requires that the cost to the enrollee is no greater 
than it would be if the services were furnished within the network. The 
regulations in this part do not prohibit single source agreements, also 
known as single case agreements, between managed care plans and out of 
network providers and we acknowledge that such arrangements may be 
necessary for the managed care plan to meet its obligations under the 
contract.
    Comment: Many commenters supported Sec.  438.206(c)(1)(i) but 
recommended that CMS add more specificity regarding the exact 
quantitative standards for timely access to care that states and 
managed care plans must implement and comply with. Many commenters 
recommended that CMS add specific quantitative standards for provider 
surveys, enrollee surveys, audits of encounter data, secret shopper 
efforts, appointment wait times, and the time and distance standards 
specified in Sec.  438.68. Several commenters recommended that states 
retain flexibility regarding access to care standards for their 
respective programs, as states need to consider state-specific 
complexities, such as the populations enrolled, scope of the program, 
state-specific private market standards, and geography. A few 
commenters recommended that CMS require states to ensure their rates 
are adequate to provide timely access to care. One commenter 
recommended that CMS require separate access to care standards for 
primary care and specialty providers. One commenter also recommended 
that CMS require states to confer with clinicians and other providers 
with clinical expertise on appropriate state standards.
    Response: We thank commenters for the variety of comments and 
recommendations on Sec.  438.206(c)(1)(i) to ensure timely access to 
care for enrollees; however, we decline to adopt specific quantitative 
standards for provider surveys, enrollee surveys, audits of encounter 
data, secret shopper efforts, appointment wait times, the time and 
distance standards specified in Sec.  438.68, or other quantitative 
standards. We believe that states should be allowed to set appropriate 
and meaningful quantitative standards for their respective programs. We 
also believe that states are in the best position to set specific 
quantitative standards that reflect the scope of their programs, the 
populations served, and the unique demographics and characteristics of 
each state. As many commenters stated, it is crucial for CMS to strike 
an appropriate balance between federal requirements and state 
flexibility. We also decline to add specific requirements for states to 
ensure their rates are adequate to provide timely access to care, as 
this requirement is already specified at

[[Page 27669]]

Sec.  438.4(b)(3) related to actuarial soundness. We also decline to 
add requirements for separate access to care standards for primary care 
and specialty providers, as we believe this is appropriately specified 
in the network adequacy standards at Sec.  438.68. Finally, while we 
encourage states and managed care plans to engage their stakeholder 
communities regarding specific and appropriate timely access to care 
standards, we decline to add requirements for states to specifically 
confer with clinicians and other providers with clinical expertise on 
appropriate state standards, as we believe that states confer with 
clinicians and other providers on a regular basis through the Medical 
Care Advisory Committee required at Sec.  431.12 of this chapter.
    Comment: A few commenters recommended that CMS clarify that the 
requirement at Sec.  438.206(c)(1)(iii) making services available 24 
hours a day, 7 days a week, when medically necessary, is related to 
emergency and inpatient services.
    Response: We agree with commenters that emergency and inpatient 
services are examples of care that should be available 24 hours a day, 
7 days a week. We note that states may specify additional medically 
necessary services under their contract with the managed care plan that 
should be available 24 hours a day, 7 days a week.
    Comment: Many commenters supported Sec.  438.206(c)(1)(iv) but 
recommended that CMS add more specificity regarding the exact 
mechanisms that managed care plans must establish to ensure timely 
access to care. Many commenters recommended that CMS require direct 
measurement of standards to test access to care. Many commenters 
recommended that CMS require mechanisms such as phone surveys with 
enrollees, secret shopper efforts, network provider audits, and CAHP 
surveys. A few commenters also recommended that CMS require such 
mechanisms to be performed by an independent third party to ensure 
accurate and unbiased results.
    Response: We appreciate the variety of comments and recommendations 
at Sec.  438.206(c)(1)(iv) to ensure appropriate mechanisms are in 
place; however, we decline to adopt such specific mechanisms for 
managed care plans to establish, such as phone surveys with enrollees, 
secret shopper efforts, network provider audits, and CAHP surveys. 
While we agree that the mechanisms suggested by commenters could be 
beneficial in measuring and ensuring timely access to care, we believe 
that as an initial measure states and managed care plans should work 
together to establish and implement appropriate and meaningful 
mechanisms for their respective programs. We also agree with commenters 
that such mechanisms could be performed by an independent third party 
and would encourage states and managed care plans to consider such 
arrangements. This is consistent with the approach that we have taken 
in other recently issued regulations (80 FR 67576) that discuss methods 
that states must take to assure access to care in their FFS systems. In 
addition, we issued a request for information (RFI) that will further 
inform our policies for access across the Medicaid program (including 
FFS and managed care delivery systems). See https://www.federalregister.gov/articles/2015/11/02/2015-27696/medicaid-program-request-for-information-rfi-data-metrics-and-alternative-processes-for-access-to. Based on the responses to the RFI and other 
efforts underway at CMS, we may, in the future, advance a national core 
set of access to care measures and thresholds or goals for access in 
the Medicaid program. If a core set of access measures were to be 
established, the process would be coordinated with the existing process 
of updating the child and adult core set of quality measures.
    Comment: A few commenters recommended that CMS require annual 
reports or an annual certification at Sec.  438.206(c)(1)(v) to ensure 
that managed care plans are monitoring network providers regularly.
    Response: While we appreciate the recommendation to include annual 
reports or an annual certification at Sec.  438.206(c)(1)(v), we do not 
believe it is necessary. Managed care plans are required to submit 
network adequacy documentation to the state on at least an annual basis 
at Sec.  438.207(c)(2). We believe that this requirement is sufficient 
to ensure that managed care plans are monitoring network providers 
regularly. Additionally, we note that Sec.  438.66(e)(2)(vi) requires 
states to report on their assessment of the accessibility and 
availability of services.
    Comment: Many commenters supported Sec.  438.206(c)(2) regarding 
access and cultural considerations. A few commenters recommended that 
CMS add specific requirements and standards, as the proposed text is 
ambiguous and hard to enforce. A few commenters also recommended 
specific language to ensure that services related to language access 
are provided to all potential enrollees and enrollees who are LEP.
    Response: We appreciate the support and recommendations regarding 
Sec.  438.206(c)(2) but decline to adopt these specific 
recommendations. We believe the language is clear that each managed 
care plan must participate in the state's efforts to promote the 
delivery of services in a culturally competent manner to all enrollees. 
States will have the authority to set specific requirements for managed 
care plans as appropriate.
    Comment: Several commenters recommended revisions to Sec.  
438.206(c)(3) regarding accessibility considerations. One commenter 
recommended adding the phrase ``age appropriate'' before physical 
access. Other commenters recommended adding ``programmatic access,'' 
``policy modifications,'' and ``effective communication.'' One 
commenter recommended revising ``accommodations'' to ``reasonable 
accommodations'' to be consistent with Sec.  438.68(c)(1)(viii). A few 
other commenters recommended that CMS remove the language, as providers 
must comply with the ADA, which is more comprehensive. One commenter 
recommended that CMS reference both the ADA and section 504 of the 
Rehabilitation Act. A few commenters recommended that CMS add specific 
requirements and standards regarding accessibility. Another commenter 
recommended that CMS require managed care plans to survey enrollees 
regarding provider accessibility. One commenter recommended that 
managed care plans add accessibility information to their provider 
directories.
    Response: We appreciate the support and recommendations regarding 
Sec.  438.206(c)(3). We decline to adopt the phrase ``age appropriate'' 
as we believe this is unnecessary. The current text requires that each 
managed care plan must ensure that network providers provide physical 
access for all enrollees with physical or mental disabilities. We 
believe this includes enrollees of all ages. We also decline to adopt 
``programmatic access,'' ``policy modifications,'' and ``effective 
communication,'' as we believe the current regulatory text provides the 
appropriate level of accessibility for enrollees with physical or 
mental disabilities. We agree with the commenter to revise 
``accommodations'' to ``reasonable accommodations'' to be consistent 
with the language at Sec.  438.68(c)(1)(viii). We are modifying the 
regulatory text to adopt this recommendation. We disagree with 
commenters that we should delete the regulatory language, as we believe 
it is appropriate to emphasize the importance of network providers 
having the capabilities to ensure physical

[[Page 27670]]

access, reasonable accommodations, and accessible equipment for the 
furnishing of services to enrollees with physical or mental 
disabilities. We also decline to reference the ADA or section 504 of 
the Rehabilitation Act specifically, as we believe this is addressed in 
Sec.  438.3(f), and providers are already required to comply with the 
ADA and section 504 of the Rehabilitation Act, as appropriate. In 
addition, we do not believe we should add specific requirements and 
standards regarding accessibility or require managed care plans to 
survey enrollees regarding provider accessibility. States will have the 
authority to set specific requirements for managed care plans as 
appropriate. Finally, we note that the requirements regarding 
accessibility and provider directories is at Sec.  438.10(h)(1)(viii); 
therefore, we decline to add such requirements here.
    Comment: A few commenters supported the addition of methods at 
Sec.  440.262 to promote access and delivery of services in a 
culturally competent manner to all beneficiaries across both Medicaid 
managed care and FFS. One commenter recommended that CMS clarify the 
specific standards against which state methods to ensure culturally 
competent access to care will be reviewed and recommended that CMS work 
with states and other stakeholders to develop appropriate review 
criteria.
    Response: We encourage states to work with their stakeholder 
community to develop methods and promote access and delivery of 
services in a culturally competent manner to all beneficiaries. We 
decline to add specific standards at Sec.  440.262, as we agree with 
commenters that we should work further with states and other 
stakeholders to develop appropriate methods and standards and review 
criteria.
    After consideration of the public comments, we are adding new 
regulatory text at Sec.  438.206(b)(7) to require a managed care plan 
to demonstrate that its network has family planning providers 
sufficient to ensure timely access to family planning services. We are 
modifying the regulatory text at Sec.  438.206(c)(3) to revise 
``accommodations'' to ``reasonable accommodations'' to be consistent 
with the language at Sec.  438.68(c)(1)(viii). We are finalizing the 
regulation text at Sec.  438.206(b)(3) to use ``network provider'' in 
place of the proposed use of ``health care professional'' for reasons 
discussed in section I.B.9.a. of this final rule. We are finalizing all 
other provisions in Sec. Sec.  438.206 and 440.262 as proposed.
(4) Assurances of Adequate Capacity and Services (Sec.  438.207)
    Currently in Sec.  438.207(a), states have to ensure, through the 
contracts and submission of assurances and documentation from managed 
care entities, that the managed care plans have the capacity to serve 
the expected enrollment in accordance with state-set standards for 
access to care. In addition, under current Sec.  438.207(b), the 
specified documentation must demonstrate the adequacy of the range of 
covered services and the provider network. We proposed to keep the 
existing regulation text in paragraphs (a) and (b) substantially the 
same, but proposed a minor amendment to specify in paragraph (b)(1) 
that supporting documentation must also address LTSS. This change is 
consistent with our broader proposal to incorporate LTSS throughout 
part 438, where applicable.
    Under current Sec.  438.207, states, through their contracts, must 
stipulate that MCOs, PIHPs, and PAHPs submit documentation that their 
network is sufficient in number, mix, and geographic distribution to 
meet, in accordance with state-set standards, the needs of anticipated 
enrollees. We proposed to amend Sec.  438.207(c) so that managed care 
plans have to submit documentation and the state has to certify the 
adequacy of the provider networks on at least an annual basis. We 
requested comment on the appropriate timeframe for submission and 
review of network certification materials.
    We also proposed to redesignate the regulation text currently at 
Sec.  438.207(c)(2) as (c)(3), which stipulates submission of 
documentation of adequate networks when there has been a significant 
change in the managed care plan's operations that would affect capacity 
and services. We proposed that a significant change in the composition 
of a MCO, PIHP, or PAHP's network itself would also trigger a 
submission of documentation to be codified in Sec.  438.207(c)(3)(i). 
For example, we noted a significant change in the composition of the 
provider network would occur when the only participating hospital 
terminates the network provider agreement, or similarly, when a 
hospital that provides tertiary or trauma care exits a managed care 
plan network. We also proposed minor edits to introductory text in 
paragraph (c)(3) to improve the readability of the paragraph.
    In paragraph (d) of Sec.  438.207, addressing the obligation of the 
state to review documentation from the MCO, PIHP, or PAHP and submit an 
assurance to us that the managed care plan meets the state's standards 
for access to services, we proposed to add an explicit standard that 
the submission include documentation of the analysis supporting the 
certification of the network for each contracted MCO, PIHP, or PAHP. We 
indicated that this is appropriate because it would demonstrate to us 
how the state evaluates plan compliance with state standards and that 
the state's assurance is supported by the data. In addition, we 
proposed to replace the word ``certify'' with ``submit an assurance of 
compliance'' to more clearly describe the responsibility of the state 
under paragraph (d). We did not propose any revision to Sec.  
438.207(e), which establishes our right to inspect the documentation 
provided under Sec.  438.207. We requested comments on the overall 
approach to Sec.  438.207.
    We received the following comments in response to our proposal to 
revise Sec.  438.207.
    Comment: A few commenters recommended that CMS add a reference to 
Sec.  438.68 at Sec.  438.207(a) to be consistent with Sec.  438.206(a) 
and other sections throughout part 438. One commenter also recommended 
that CMS add a reference to Sec.  438.206(c)(1).
    Response: We agree with commenters that Sec.  438.207(a) could be 
clarified with additional references to the specific access to care 
standards at Sec. Sec.  438.68 and 438.206(c)(1). We are modifying the 
regulatory text to adopt this recommendation.
    Comment: Many commenters recommended specific revisions at Sec.  
438.207(b)(1) and (2) related to the documentation requirements to 
support that each managed care plan is offering an appropriate range of 
preventive, primary care, specialty services, and LTSS (if appropriate) 
and maintaining a network of providers that is sufficient in number, 
mix, and geographic distribution to meet the needs of the anticipated 
number of enrollees in the service area. Many commenters recommended 
that CMS set specific quantitative standards regarding the sufficient 
number of specific provider types and categories that each managed care 
plan must include in their documentation. Specifically, commenters 
recommended that CMS include specific data submission requirements when 
submitting the specified supporting documentation. A few other 
commenters recommended that CMS include specific documentation 
requirements for pediatric and specialty providers, including 
specialists that treat rare and highly specialized health conditions. A 
few commenters recommended that

[[Page 27671]]

CMS specify the types of analyses that managed care plans should be 
conducting and submitting to the states. One commenter recommended that 
CMS require that states compare managed care plan documentation 
submissions to the provider directories of each managed care plan to 
ensure compliance. A few commenters recommended that CMS specify LTSS 
requirements in more detail and be specific about the kinds of 
documentation states should be allowed to accept to ensure an adequate 
number and mix of LTSS providers. Several commenters also recommended 
that CMS include specific requirements for stakeholder engagement, 
especially for LTSS programs and providers.
    Response: We thank commenters for the comments and recommendations 
at Sec.  438.207(b)(1) and (2) but decline to adopt commenters' 
recommendations regarding specific quantitative thresholds or the 
specific and sufficient number of provider types and categories that 
each managed care plan must include in their documentation. Consistent 
with our approach at both Sec.  438.68 regarding time and distance 
network adequacy standards and Sec.  438.206(c)(1) regarding state 
established timely access to care standards, we are not setting 
specific quantitative standards or thresholds for Medicaid managed care 
programs. We believe that states should set appropriate and meaningful 
quantitative standards for their respective programs and that they are 
in the best position to set specific quantitative standards that 
reflect the scope of their programs, the populations served, and the 
unique demographics and characteristics of each state. As many 
commenters stated, it is crucial for CMS to strike an appropriate 
balance between federal requirements and state flexibility. We are 
finalizing the rule that we think does that.
    We decline to add specific documentation requirements for pediatric 
and specialty providers, as we believe this is appropriately specified 
in the network adequacy standards at Sec.  438.68. We also decline to 
set specific data submission requirements or set specific requirements 
regarding the types of analyses that managed care plans should be 
submitting to states. These recommendations are too prescriptive and 
would not provide states the flexibility to specify the types of 
analyses and the format of such analyses for their respective programs. 
We believe it is appropriate to require supporting documentation as an 
overarching federal framework but decline to set prescriptive 
requirements on the kinds or format of such documentation. We also 
decline to require states to compare managed care plan documentation 
submissions to provider directories. While this might be a beneficial 
exercise, it may not be the most appropriate method for states to 
verify compliance. States should be allowed flexibility in the methods 
they utilize to verify the documentation and ensure that managed care 
plans are meeting all of the requirements at Sec.  438.207(b)(1) and 
(2).
    Finally, we thank commenters for the recommendations regarding more 
specificity related to LTSS programs and providers. Consistent with our 
approach at Sec.  438.68, we decline to include specific requirements 
regarding the numbers and types of LTSS providers to ensure an adequate 
mix. We believe that states are in the best position to determine the 
exact requirements, depending on the scope of their LTSS programs and 
the populations served. We also note that at Sec.  438.70, states must 
ensure the views of beneficiaries, providers, and other stakeholders 
are solicited and addressed during the design, implementation, and 
oversight of a state's managed LTSS program. This includes the 
supporting documentation requirements at Sec.  438.207(b)(1) and (2). 
We encourage states and managed care plans to engage their stakeholder 
communities regarding specific and appropriate timely access to care 
standards and supporting documentation requirements.
    Comment: Many commenters supported Sec.  438.207(c)(2) regarding 
the annual requirement for managed care plans to submit the supporting 
documentation to states related to the network adequacy and timely 
access to care standards specified at Sec.  438.207(b)(1) and (2). Many 
commenters also disagreed with the annual requirement, as they found 
such a requirement to be burdensome on both managed care plans and 
states and found the requirement to be duplicative of existing EQR 
requirements. Many commenters recommended that CMS revise the annual 
requirement to once every 3 years. Other commenters recommended that 
CMS remove the annual requirement in its entirety. A few commenters 
recommended that CMS revise the annual requirement to quarterly to 
ensure a greater level of compliance between states and managed care 
plans. Several commenters supported the annual requirement but 
recommended that the annual requirement include independent 
verification by a third party. Finally, several commenters also 
recommended that CMS include requirements for states to conduct annual 
reviews of the data to ensure compliance.
    Response: We thank commenters for the thoroughness of their 
recommendations regarding Sec.  438.207(c)(2) and the annual 
requirement for managed care plans to submit supporting documentation 
to states regarding network adequacy and access to care. We understand 
commenters' concerns regarding burden and costs on both managed care 
plans and states. However, we believe that the annual requirement 
should remain in place to ensure the highest level of access to care 
for enrollees. Network adequacy and access to care have increasingly 
become important aspects of the health care market and industry. We 
believe it is reasonable to expect that managed care plans evaluate 
their provider networks and ensure access to care for all enrollees on 
at least an annual basis. Therefore, we decline to adopt commenters' 
recommendations to revise the requirement or remove it in its entirety. 
While we appreciate commenters' recommendations to ensure that all 
supporting documentation is verified by an independent third party and 
that states should conduct annual reviews of the data to ensure 
compliance, we believe that states should be allowed flexibility in the 
methods they use to verify the documentation and ensure that managed 
care plans are meeting all of the requirements at Sec.  438.207(b)(1) 
and (2).
    Comment: Many commenters supported Sec.  438.207(c)(3)(i) and (ii) 
regarding documentation requirements at any time there has been a 
significant change in the managed care plan's operations that would 
affect the adequacy of capacity and services. Several commenters 
recommended that CMS define ``significant change'' to add further 
specificity. Several commenters recommended that CMS also clarify that 
such documentation should be required within 10 working days of a 
``significant change.''
    Response: We understand commenters' concerns regarding the 
definition of ``significant change'' and the recommendation to set 
timeframe parameters around the requirement of submitting documentation 
to coincide with the occurrence of a ``significant change.'' However, 
as we proposed, we believe that states should define ``significant 
change'' for their respective programs. In Sec.  438.207(c)(3), states 
must include, at a minimum, significant changes related to the managed 
care plan's services, benefits, geographic service area, composition of 
or payments to the provider network, and

[[Page 27672]]

any enrollment of new populations in the managed care plan. We also 
decline to adopt the specific recommendation to clarify that 
documentation should be required within 10 working days of a 
``significant change.'' We encourage managed care plans to submit and 
for states to require documentation as soon as feasible after a 
significant change has occurred to ensure that access to care is not 
compromised for enrollees. We also encourage states and managed care 
plans to consider the impact of such significant changes and ensure 
that documentation timeframes are commensurate with the level and 
impact of changes on enrollees.
    Comment: Many commenters supported Sec.  438.207(d) regarding the 
state's review and certification to CMS that managed care plans meet 
requirements for availability and accessibility of services. Several 
commenters recommended that CMS include a specific reference to Sec.  
438.68 related to the state's network adequacy standards. Many 
commenters also recommended that CMS add requirements for the 
documentation and certification of such documentation to be made public 
and posted on the state's Medicaid Web site.
    Response: We agree with commenters that Sec.  438.207(d) could be 
strengthened with an additional reference to the network adequacy 
standards at Sec.  438.68 as well as a reference to Sec.  438.206. We 
are modifying the regulatory text to adopt this recommendation. 
However, we decline to add requirements for the documentation and 
certification of such documentation to be made public and posted on the 
state's Medicaid Web site, as Sec.  438.66(e)(3)(i) already addresses 
public disclosure of information related to networks and access. States 
must include information regarding the performance of both their 
network adequacy standards and the availability and accessibility of 
services at Sec.  438.66(b)(11) in their managed care program 
assessment report. We believe this is the most appropriate place for 
this requirement.
    After consideration of the public comments, we are modifying the 
regulatory text at Sec.  438.207(a) to add references to Sec. Sec.  
438.68 and 438.206(c)(1) to be consistent with Sec.  438.206(a) and 
other sections throughout part 438. We are also modifying the 
regulatory text at Sec.  438.207(d) to include a specific reference to 
Sec.  438.68 to be consistent with the reference to Sec.  438.206. We 
are finalizing all other sections as proposed.
b. Quality of Care (Subparts D and E of Part 438)
    Section 1932(c) of the Act establishes quality assurance standards 
for Medicaid managed care programs, specifically, a quality assessment 
and improvement strategy and an external independent review of 
contracting MCOs. Regulations at 42 CFR part 438, subparts D (Quality 
Assessment and Performance Improvement) and E (External Quality Review) 
implement this statutory provision; subpart D became effective on 
August 13, 2002 (67 FR 40989) and subpart E became effective on March 
25, 2003 (68 FR 3586). Based on the authority under section 1902(a)(4) 
of the Act, we included capitated entities in addition to MCOs, within 
the scope of the regulatory requirements. The existing regulations 
describe quality standards for all states contracting with MCOs, PIHPs, 
and in some cases PAHPs, for the delivery of Medicaid services to 
beneficiaries. This final rule modifies these standards.
    Approaches to assessing quality, access, and timeliness of care 
have evolved significantly over the past 10 years. At the federal 
level, CHIPRA, the American Recovery and Reinvestment Act (ARRA), the 
Affordable Care Act, the National Quality Strategy, and the CMS Quality 
Strategy all build on one another to decrease burdens, improve 
alignment, and encourage innovative approaches to quality measurement 
and improvement, among other activities. States also have expanded the 
use of managed care for the delivery of primary care, acute care, 
behavioral health services, and LTSS to Medicaid beneficiaries, and the 
proposed regulation reflected that development. Throughout the proposed 
rule, we proposed changes to maximize the opportunity to improve health 
outcomes over the lifetime of individuals. Specifically, we proposed to 
strengthen quality measurement and improvement efforts in managed care 
by focusing on the following three principles:
    (1) Transparency: Public reporting of information on quality of 
care is a widely recognized tool for driving improvements in care 
across settings. A key component in designing health care quality 
transparency initiatives is the use of meaningful and reliable data 
that is comparable across managed care plans, providers, and programs. 
The regulatory changes proposed are intended to improve transparency 
with the goal of increasing both state and managed care plan 
accountability in the quality of care provided to Medicaid 
beneficiaries. Transparency will help stakeholders (including 
beneficiaries) to engage in informed advocacy, compare the performance 
of providers and managed care plans, and make informed managed care 
plan choices.
    (2) Alignment with other systems of care: Integrating the 
approaches to quality measurement and improvement across different 
programs will result in a more streamlined system for states, managed 
care plans, stakeholders, and beneficiaries. Many managed care plans 
offer options in more than one program type, and beneficiaries may 
transition between programs as their circumstances change. Coordination 
of quality measurement and improvement across different programs can 
result in economies of scale and increase the effectiveness of quality 
improvement efforts in each program. The proposed regulation therefore 
sought to achieve alignment with the quality measurement and 
improvement standards applied to Medicare Advantage organizations and 
QHPs in the Marketplace.
    (3) Consumer and Stakeholder Engagement: Consumer and stakeholder 
engagement is particularly important when designing an approach to 
measuring quality for Medicaid managed care, including programs 
delivering LTSS. Providing consumers with information about their 
managed care plan is one tool for engaging them in health care 
decision-making; another is soliciting consumer participation in the 
development of state strategies for improving care and quality of life. 
The regulatory changes proposed sought to strengthen the role of 
consumers in health care decision-making through use of new tools to 
enhance active engagement.
    We received the following comments in response to our proposed 
quality principles.
    Comment: Many commenters expressed support for the principles of 
transparency, alignment with other systems of care, and consumer and 
stakeholder engagement underpinning the quality revisions. One 
commenter recommended that CMS add a fourth principle focused on 
improved consumer experience of care.
    Response: We thank the commenters for their support. While the 
principles identified were used in the development of the proposed rule 
and therefore cannot be altered, we agree that improving consumer 
experience of care is important and is supported by adherence to the 
other three principles. In particular, we believe that the increased 
availability of quality information (under Sec. Sec.  438.334 and 
438.364), the availability of the quality strategy online (per Sec.  
438.340), and the

[[Page 27673]]

application of EQR to PAHPs and select PCCM entities (described in 
Sec.  438.310(c)(2)), in addition to MCOs and PIHPs will support an 
improved consumer experience of care.
(1) Proposed Revisions of Subpart D
(a) Subpart D Title and Subheadings
    As discussed in the proposed revisions to subpart E below, we 
proposed that sections related to the quality strategy currently found 
in subpart D be moved to subpart E. We proposed to make minor 
conforming changes to subpart D and to change the name from ``Quality 
Assessment and Performance Improvement'' to ``MCO, PIHP, and PAHP 
Standards.'' We believe this change more accurately describes the 
remaining sections of subpart D, which address MCO, PIHP, and PAHP 
activities, some of which are measured as part of the state quality 
strategy. Additionally, we proposed to remove the subheadings found in 
subpart D to be consistent with the remaining subparts in part 438. 
These subheadings would no longer be necessary because the section 
titles discuss what types of standards are found in subpart D.
    We did not receive any comments in response to our proposal to 
revise subpart D title and subheadings, and therefore, are finalizing 
as proposed.
(b) Removal of Sec. Sec.  438.200, 438.202, 438.218, and 438.226
    As discussed in section I.B.6.b(1)(a) of the proposed rule, the 
proposed consolidation of all quality-related standards under subpart E 
would render Sec.  438.200, which describes the quality-centric scope 
of subpart D, unnecessary. We thus proposed to remove Sec.  438.200 in 
its entirety.
    We proposed to remove Sec.  438.202, due to the standards we 
proposed in the new part 431, subpart I.
    We proposed to remove Sec.  438.218, which incorporates enrollee 
information requirements in Sec.  438.10 into the state's quality 
strategy. Proposed changes to both enrollee information requirements at 
Sec.  438.10 and the elements of a state's comprehensive quality 
strategy at Sec.  438.340 would render Sec.  438.218 duplicative and 
unnecessary.
    Similarly, we proposed to remove Sec.  438.226, which incorporates 
the enrollment and disenrollment standards in Sec.  438.56 into the 
state's comprehensive quality strategy. Because we proposed deleting 
these elements from inclusion in a state's comprehensive quality 
strategy (see Sec.  438.340), it would render Sec.  438.226 
unnecessary.
    We did not receive any comments in response to our proposal to 
remove Sec. Sec.  438.200, 438.202, 438.218, and 438.226. While we are 
withdrawing our proposal for a new subpart I of part 431 requiring a 
new comprehensive quality strategy that would have applied across all 
delivery models (see discussions in section b.(2)(f) below), it is 
still appropriate to remove Sec.  438.202 due to revisions to Sec.  
438.340 in the final rule. Therefore, we are finalizing these removals 
as proposed.
(2) Proposed Revisions of Subpart E
(a) Scope (Sec.  438.310)
    This section explains the basis, scope, and applicability of 
subpart E, which provides details on the EQR process for MCOs and 
PIHPs. Generally, subpart E covers the selection of EQR reviewers, 
their qualifications, types of EQR-related activities, the availability 
of EQR results, and the circumstances in which EQR may use the results 
from a Medicare or private accreditation review. Because we proposed to 
move and revise the existing standards related to both the managed care 
quality strategy and the QAPI program from subpart D to subpart E, we 
proposed in paragraph (a) to include section 1932(c)(1) of the Act as 
part of the statutory basis for the quality strategy provisions. In 
addition, we proposed to include section 1902(a)(19) of the Act as part 
of the statutory basis, which maintains that each state provide such 
safeguards as may be necessary to assure that eligibility for care and 
services under the plan will be determined, and such care and services 
will be provided, in a manner consistent with simplicity of 
administration and the best interests of the recipients. We believe 
this authority would be applicable to both existing provisions of the 
regulation and some of our proposed changes.
    Under the existing quality provisions, states contracting with MCOs 
and PIHPs must draft and implement a quality strategy and all MCOs and 
PIHPs must undergo an annual EQR. As states expand their use of managed 
care for other services or populations, it is increasingly important to 
develop a comprehensive approach to measuring and improving quality. 
Because some PAHPs might provide dental or behavioral health services, 
we proposed that states address such plans in the state's comprehensive 
quality strategy, with performance results publicly available in the 
EQR technical reports. Therefore, we proposed to rely on the authority 
of section 1902(a)(4) of the Act to apply the quality standards of 
section 1932(c) of the Act to PAHPs and PIHPs. Throughout subpart E, as 
well as in Sec.  438.310, we proposed the addition of ``PAHPs'' as 
necessary to reflect this proposal. Some PAHPs function as brokers of 
non-emergency medical transportation (NEMT), so much of subparts D and 
E would not apply to these NEMT PAHPs. The provisions that apply to 
NEMT PAHPs were identified in the proposed changes to Sec.  438.9.
    We also proposed to delete the specific reference to health 
insuring organizations (HIOs), throughout subpart E because with the 
exception of those HIOs that are expressly exempt by statutory law, 
HIOs under the proposed rule would be treated in the same manner as an 
MCO. We proposed in Sec.  438.310(b) to identify the scope of subpart 
E, including specifications for a process to ensure review and approval 
of managed care plans, quality ratings, the quality strategy, and EQRs. 
In paragraph (c)(1), we proposed that these specifications apply to 
MCOs (including non-exempt HIOs), PIHPs, and PAHPs. Finally, we 
proposed in Sec.  438.310(c)(2) to address the elements related to 
quality assessment and improvement for states contracting with PCCM 
entities. Specifically, we proposed that states assess the performance 
of PCCM entities consistent with Sec.  438.3(r); such assessment would 
include a review of at least the mechanisms to detect under- and over-
utilization of services, performance measures, and program review (by 
reference to specific provisions proposed at Sec.  438.330).
    We received the following comments in response to our proposal to 
revise Sec.  438.310.
    Comment: We received several comments in support of the proposal to 
require states to assess the performance of PCCM entities consistent 
with Sec.  438.3(r).
    Response: We thank the commenters for their support and are 
retaining this requirement in the final rule. However, to improve 
clarity, we are revising the regulation text in Sec.  438.310(c)(2) in 
the final regulation to include the description of the types of PCCM 
entities Sec.  438.330(b)(2), (b)(3), (c), and (e), Sec.  438.340, and 
Sec.  438.350 apply to, and revising Sec.  438.3(r) to cross-reference 
Sec.  438.310(c)(2).
    Comment: One commenter asked for guidance as to how to apply the 
quality requirements described in Sec.  438.3(r) to a PCCM entity that 
only provides case management services. Additionally, the commenter 
asked if CMS will require an EQR of PCCM entities.
    Response: Only PCCM entities that meet the conditions specified in 
proposed Sec.  438.3(r) and finalized in Sec.  438.310(c)(2) (that is, 
PCCM entities

[[Page 27674]]

whose contract provides for shared savings, incentive payments or other 
financial reward for improved quality outcomes) are subject to the 
requirements set forth in Sec. Sec.  438.330(b)(2), (b)(3), (c) and 
(e), Sec.  438.340 and Sec.  438.350. This means that under the final 
rule, PCCM entities (described in Sec.  438.310(c)(2)) will be required 
to undergo an annual EQR (see section I.B.6.b(h) below for additional 
discussion of EQR, including its application to some PCCM entities). If 
the contract does not contain such financial incentives, compliance 
with these provisions is not required under the regulations; however, 
the regulations do not preclude states from opting to apply similar 
requirements to other PCCMs or PCCM entities at their discretion.
    Comment: Several commenters supported the proposal to apply the 
quality standards of section 1932(c) of the Act to PAHPs and PIHPs. 
Most of those commenters noted that as PAHPs have expanded to provide a 
broader array of services, they should be subject to the quality 
standards required of other managed care programs.
    Response: We thank the commenters for their support and are 
finalizing the addition of PAHPs as proposed. We note that these 
quality provisions have applied to PIHPs since the original EQR final 
rule was issued in 2003, and will continue to apply to PIHPs under this 
final rule.
    Comment: One commenter expressed concern with the application of 
the quality standards to dental PAHPs and urged CMS to consider 
exempting dental PAHPs from the proposed rule.
    Response: We are not accepting the comment, as we do not believe 
dental PAHPs are sufficiently different from other limited benefit 
PAHPs to warrant exemptions in part or in whole from 42 CFR part 438 
subpart E.
    Comment: One commenter believed that NEMT PAHPs should be held to 
the same federal quality standards under subpart E as other PAHPs since 
they provide a critical service to beneficiaries as the gateway to 
access needed care.
    Response: While we agree that the services provided by NEMT PAHPs 
are critical to beneficiaries, we believe that NEMT PAHPs are 
sufficiently different from PAHPs that provide medical services and 
LTSS to warrant an exemption from subpart E.
    Comment: A few commenters requested that CMS cross-reference Sec.  
438.14 to ensure the quality assessment activities in part 438 subpart 
E address compliance with provisions relating to managed care contracts 
involving Indians, IHCPs and IMCEs.
    Response: We agree that a state's oversight practices should 
address all populations within its Medicaid managed care program, 
including Indians; however we disagree that part 438 subpart E broadly 
applies to Sec.  438.14. Section 438.14 addresses network and payment 
requirements for managed care plans that serve Indians and contract 
with Indian health care providers; compliance with these provisions 
generally is outside of the scope of 438 subpart E. The one exception 
is Sec.  438.358(b)(1)(iv), which requires network adequacy validation 
as part of the EQR process. We therefore are adding a cross reference 
to Sec.  438.14(b)(1) (relating to network adequacy for managed care 
plans serving Indians) in Sec.  438.358(b)(1)(iv).
    After consideration of the public comments, we are finalizing this 
section with modification to clarify the application of part 438 
subpart E to select PCCM entities. Specifically, we are modifying Sec.  
438.3(r) to cross-reference Sec.  438.310(c)(2), which we are modifying 
to describe the types of PCCM entities subject to subpart E (those 
whose contract with the state provide shared savings, incentive 
payments or other financial reward for improved quality outcomes) and 
to correctly state that Sec.  438.330(b)(2), (b)(3), (c), (e), Sec.  
438.340, and Sec.  438.350 apply to these PCCM entities. We are 
revising Sec.  438.310(b)(5) to address PCCM entities, consistent with 
our revision to Sec.  438.310(c)(2). We are making corresponding 
changes in Sec. Sec.  438.320, 438.330, 438.340, and 438.350 to reflect 
their application to these PCCM entities. Note that other sections of 
the regulation cross-referenced in Sec.  438.350 also apply to PCCM 
entities described in Sec.  438.310(c)(2) under the revisions made in 
the final regulation. We are also making a technical modification to 
paragraph (c)(1) to remove the reference to HIOs; by default, HIOs 
which are not expressly exempt under statute will be subject to the 
standards that apply to an MCO, consistent with section 1903(m)(2)(A) 
of the Act.
(b) Definitions (Sec.  438.320)
    This section of the current regulations defines terms related to 
the EQR process, including EQR, EQRO, financial relationship, quality, 
and validation. We did not propose to change the definitions for EQR, 
financial relationship, and validation, other than the addition of 
``PAHP'' as necessary. Because the EQR process involves an analysis and 
evaluation of the quality, timeliness, and access to services that a 
managed care plan furnishes, we proposed adding a definition for 
access, as it pertains to EQR, by referring to the timely provision of 
services in accordance with the network adequacy standards proposed in 
Sec.  438.68 and availability of services standards in Sec.  438.206.
    We proposed revising the definition of ``external quality review 
organization'' (EQRO) to clarify that an entity must also hold an 
active contract with a state to perform EQR or EQR-related activities 
to be considered an EQRO. Therefore, an entity itself would not be 
considered an EQRO if it has not yet entered into an EQRO arrangement 
with a state even if it meets all qualifications for entering into such 
a contract.
    We also proposed to modify the definition of ``quality'' as it 
pertains to EQR to reflect that professional knowledge must be 
evidence-based and supported by current science. Consistent with the 
revised definition, states and their plans will be expected to stay up-
to-date on the latest scientific findings and translate those findings 
into effective practices, as many states and plans already attempt to 
do. We also proposed to modify the definition of quality by including 
performance measure trends and performance improvement outcomes (which, 
for individuals receiving MLTSS, could include considerations around 
quality of life).
    We received the following comments in response to our proposal to 
revise Sec.  438.320.
    Comment: A few commenters recommended that CMS use terminology and 
requirements for Medicaid that are similar to those used for Medicare/
MA. The commenters believed doing so would promote efficiency.
    Response: While we agree with and support alignment between 
Medicaid and Medicare, including MA, and we took into account Medicare 
terminology to the extent possible, the definitions for the QAPI 
program and EQR in this rulemaking reflect unique requirements for 
Medicaid managed care. Therefore, the definitions presented here are 
specific to the Medicaid program.
    Comment: Several commenters supported the proposed definition of 
access. Most commenters also recommended that the definition should 
cross-reference the care coordination provisions of Sec.  438.208 
because adequate care coordination and protections for moving between 
providers are important components of access to care, particularly for 
individuals who require LTSS.

[[Page 27675]]

    Response: We disagree with the recommendation to cross-reference 
the care coordination provisions in Sec.  438.208 in the definition of 
access, which we are finalizing as proposed, except for minor revisions 
for clarity. The rules to ensure care coordination and continuity of 
services for all managed care plan beneficiaries are explicit in Sec.  
438.208. We believe that a plan's standards for network adequacy (Sec.  
438.68, which requires the state to develop and enforce network 
adequacy standards) and accessibility (Sec.  438.206, which requires 
that all covered services be available and accessible to beneficiaries 
in a timely manner), along with the requirement that the results of EQR 
(per Sec.  438.364) include an assessment of the quality, timeliness, 
and access to health care services, are sufficient to ensure that a 
state will measure whether care is coordinated to achieve the best 
outcomes.
    Comment: Several commenters expressed concern that the proposed 
definitions of ``external quality review'' and ``quality'' include the 
phrase ``health care services'' or ``health outcomes,'' which are 
clinically focused and do not reflect LTSS. Several commenters 
recommended that the definitions should reflect a broad understanding 
of health and well-being, including function, quality of life, and 
ability to independently live and engage in community life. One 
commenter referenced CMS guidance from 2012 that applied EQR protocols 
to LTSS. Commenters recommended striking descriptive adjectives that 
reflect solely health and clinical outcomes, such as striking ``health 
care'' prior to ``services'', and to instead use the term ``covered 
services'' to reflect all services that an MCO, PIHP, PAHP or their 
contractors furnish to Medicaid beneficiaries. Commenters also 
recommended alternatively adding a definition of ``health care 
services'' that is broad and includes all services covered under the 
managed care contract, including LTSS, if covered. Some commenters 
recommended adding a definition of ``outcome'' to include ``changes in 
patient health, functional status, quality of life, goal achievement, 
or ability to live and engage in community life that result from health 
care or supportive services.''
    Response: Other than to include PAHPs within the scope of an EQR, 
we did not propose revisions to the definition of ``external quality 
review'' in the proposed rule and are finalizing only the revisions 
proposed. We are accepting the recommendation to replace the reference 
to ``desired health outcomes'' in the definition of quality with 
``desired outcomes'' to be more inclusive of LTSS. We agree with the 
commenter that the EQR should examine the full range of services 
provided by a managed care plan, and that LTSS are included within the 
scope of services subject to EQR. We also are adding a definition of 
``health care services'' in Sec.  438.320 of the final rule to mean all 
Medicaid services provided by an MCO, PIHP, or PAHP under contract with 
the State Medicaid agency in any setting, including but not limited to 
medical care, behavioral health care, and LTSS. We note that this is 
consistent with our 2012 guidance on the application of EQR protocols 
to managed long-term services and supports (MLTSS) (available at http://www.medicaid.gov/medicaid-chip-program-information/by-topics/delivery-systems/downloads/cmcs-eqr-protocols.pdf). We also agree with the 
inclusion of a comprehensive definition of ``outcomes'' in Sec.  
438.320. Rather than adopting the definition proposed by commenters, we 
are adopting the definition included in the 2012 guidance cited above. 
Finally, we did propose to delete ``health'' before ``services'' in 
reference to ``the provision of services'' that are consistent with 
current professional evidenced-based knowledge in paragraph (2) of the 
definition of quality in proposed Sec.  438.320, which we retain in the 
final rule. We also finalize the other proposed revisions to the 
definition of ``quality'' in Sec.  438.320.
    Comment: A few commenters expressed concern that the proposed 
definition of EQRO applies only to entities that have contracts with 
states as the EQRO. They stated that this might prevent other entities 
from becoming an EQRO and could have an unintended impact of limiting 
the market to existing EQROs, even if they do not have adequate 
competence in LTSS. One commenter noted that limiting the market to 
EQROs that have contracts with states could over time lead the EQRO 
market to become overpriced, with insufficient capacity, and without 
incentive for innovation and investment. Another commenter requested 
that CMS reconsider including competence in LTSS in the definition.
    Response: In proposing to clarify the definition of ``external 
quality review organization,'' we did not intend to limit the field of 
potential EQROs to those holding contracts with states today. We agree 
that such a limitation could have a negative impact. To ensure that the 
definition is not inadvertently interpreted to limit the pool of 
entities with which states can contract in the future to entities with 
EQR contracts in effect today, we are not finalizing the proposed 
revision. However, we disagree with the suggestion that LTSS competence 
be specifically included in the definition of an entity that qualifies 
to be an EQRO. Section 438.354(b) addresses the competence requirements 
for an EQRO that include having the clinical and nonclinical skills 
necessary to carry out EQR or EQR-related activities; we believe that 
the description is broad enough to cover the range of services a 
managed care plan might cover, including LTSS, and therefore are not 
accepting the suggestion.
    Comment: Another commenter suggested that an EQRO-like and/or QIO-
like entity with requisite competence and independence should always be 
deemed acceptable as an EQRO applicant as a state is evaluating and 
determining an organization to serve as their EQRO.
    Response: We agree that an EQRO-like and/or QIO-like entity with 
the requisite competence and independence would be an acceptable EQRO 
applicant. However, not every EQRO-like or QIO-like entity necessarily 
meets the requirements in Sec.  438.354, and only such entities that do 
so, as determined by state review, may be awarded an EQR contract with 
a state. It is the responsibility of a state to review an entity's bid 
to determine if the entity meets the requirements in Sec.  438.354.
    Comment: With regard to the proposed definition of quality, one 
commenter recommended that CMS remove the term ``positive trends'' from 
the reference to performance measures and outcomes because there may 
not always be positive trends. Another commenter requested guidance on 
how states may ensure that the provision of services is consistent with 
``current professional evidence-based knowledge.'' The commenter 
questioned whether measures from a reputable standard-setting entity 
will be assumed to meet the requirement. The commenter also requested 
guidance on what would be required in instances in which the Medicaid 
agency and its EQRO use metrics developed by other entities.
    Response: We reexamined our proposed definition for quality and 
while we believe that the consideration of trends is important (as the 
directions and size of trends may offer valuable information about 
performance), performance measurement trends alone do not increase the 
likelihood of desired outcomes for a plan's enrollees. The intent of 
performance improvement

[[Page 27676]]

projects (PIPs) is to improve the quality of care provided to 
enrollees; therefore, while the results of these projects do not 
necessarily increase the likelihood of improved outcomes, the use of 
PIPs does. Similarly, the term ``clinically significant results'' 
focuses on the potential outcomes, rather than the PIP. Therefore we 
are revising the third part of the quality definition to remove the 
reference to positive trends in performance measures but leave the 
reference to interventions for performance improvement, though without 
the ``clinically significant results'' modifier. We will provide 
further guidance in EQR protocols regarding how states can ensure that 
the provision of services is consistent with ``current professional 
evidence-based knowledge'' and how this may affect measure selection.
    Comment: Several commenters expressed concern that the use of the 
word ``review'' in the definition of ``validation'' could be construed 
to preclude the creation of new data as part of the validation process, 
such as through a secret shopper or beneficiary survey to validate a 
plan's network adequacy. They recommended adding a reference to 
``direct testing'' to the definition after the word ``review'' and to 
include a definition of direct testing, as it pertains to EQR, to mean 
the proactive testing of managed care plans' compliance with state 
standards and requirements, including the accuracy of information 
maintained and reported by managed care plans. Commenters suggested 
examples of direct testing to include: making direct calls to network 
providers to determine availability and accessibility; conducting 
systematic evaluations of consumer service calls; and comparing 
encounter data against a statistically valid sample of individual 
medical records. Alternatively, a commenter recommended requiring 
direct testing in the EQR protocols.
    Response: We did not propose revisions to the definition of 
``validation'' and are not making any revisions in this final rule. We 
disagree with the need to revise the current definition of validation, 
which is broad enough to encompass a variety of techniques, including 
direct testing. The specifics of each EQR-related activity, such as 
those suggested by commenters, are appropriate for the EQR protocols, 
not the definition of validation in the regulation. We also disagree 
with the need for a definition of direct testing. This section provides 
definitions for terms within 438 subpart E; the term direct testing is 
not used in this subpart.
    Comment: One commenter requested that CMS include a definition of 
``performance improvement project.''
    Response: We disagree with the need to define ``performance 
improvement project'' in Sec.  438.320. The expectations for PIPs are 
set forth in Sec.  438.330(d) of the final rule.
    After consideration of the public comments, we are modifying the 
regulatory text at Sec.  438.320 to: (1) incorporate a definition for 
health care services and outcomes which are based on the definitions 
for these terms included in our 2012 guidance on the application of EQR 
to MLTSS; (2) modify the definition for quality to remove the reference 
to positive trends in performance measures and to clinical significant 
results; and (3) revert to the current definition for EQRO to ensure 
that the definition does not inadvertently limit the market to entities 
with EQR contracts in effect today. As discussed in section 
I.B.6.b(2)(a) of this preamble, we are modifying the definitions for 
EQR and quality to reflect that PCCM entities (described in Sec.  
438.310(c)(2)) must undergo an annual EQR.
(c) Quality Assessment and Performance Improvement Program (Sec.  
438.330, Formerly Sec.  438.240)
    We proposed to recodify the standards related to a QAPI program, 
previously described in Sec.  438.240, at Sec.  438.330. In Sec.  
438.330(a)(1) we proposed incorporating PAHPs for the reasons mentioned 
previously in this preamble. We proposed including the word 
``comprehensive'' to signal that states should consider all populations 
and services covered by managed care when developing QAPI standards for 
their contracted managed care plans. In Sec.  438.330(a)(2), we 
proposed to revise the existing regulatory language at Sec.  
438.240(a)(2) to permit us, in consultation with states and other 
stakeholders, to specify performance measures and topics for PIPs for 
inclusion alongside state-specified measures and topics in state 
contracts with their MCOs, PIHPs, and PAHPs. We proposed to add that we 
would also establish a methodology for quality ratings, which is 
discussed in more detail below in connection with proposed Sec.  
438.334. We proposed this would be accomplished after notice and public 
comment to ensure that states, beneficiaries, and other stakeholders 
had the opportunity to provide input during the measure selection 
process. We proposed, in Sec.  438.330(a)(2)(ii), to adopt a mechanism 
to permit an exemption from the nationally identified PIP topics and 
metrics for states that request one. We considered which criteria might 
be appropriate for the exemption process and invited comment on 
instances in which an exemption may be appropriate.
    In paragraph (b), we proposed to recodify and reorganize the 
substance of existing Sec.  438.240(b) consistent with our proposal to 
move all quality program provisions to subpart E. In paragraph (b)(1), 
we proposed moving the description of what PIPs are designed to achieve 
to paragraph (d) to describe all PIP-specific details in one place. In 
paragraph (b)(2), we proposed to modify the existing language from 
``submit performance measurement data'' to ``collect and submit 
performance measurement data.''
    We proposed in paragraph (b)(5) that MCOs, PIHPs, and PAHPs have 
specialized mechanisms to assess the quality and appropriateness of 
care furnished to enrollees receiving LTSS. This would include an 
assessment of the care that individuals receive when transitioning to 
different service settings, such as residential to community (or vice 
versa) or residential to hospital (or vice versa). We encouraged states 
to consider including language in their MCO, PIHP, and PAHP contracts 
that incorporates the use of surveys to assess the experience of 
beneficiaries receiving LTSS as a key component of the plan's LTSS 
assessment process. We solicited comment on the current use of such 
surveys and how they might best be used to improve the delivery of LTSS 
to beneficiaries and improve their experience of care. We also proposed 
that MCOs, PIHPs, and PAHPs compare the services that an individual 
receiving LTSS has obtained with those that were in the individual's 
LTSS treatment plan. Lastly, we proposed in paragraph (b)(6) that MCOs, 
PIHP, and PAHPs participate in efforts by the state to prevent, detect, 
and remediate critical incidents, based on applicable standards on the 
state for home and community based waiver programs.
    In paragraph (c)(1), we proposed to delete the reference to Sec.  
438.204(c), as we proposed removing this from the managed care elements 
for inclusion in a state's comprehensive quality strategy, as described 
in the proposed Sec.  438.340 (currently Sec.  438.204); our other 
proposed revisions to paragraphs (c)(1) through (c)(3) were to conform 
it to the remainder of our proposal and to incorporate PAHPs.
    We proposed the addition of paragraph (c)(4), to require that MCOs, 
PIHPs, and PAHPs that provide LTSS include, in addition to other 
performance measures under paragraphs

[[Page 27677]]

(c)(1) through (c)(3), LTSS-specific performance measures that examine, 
at a minimum, beneficiaries' quality of life and a plan's rebalancing 
and community integration outcomes. We expected these measures would 
support and align with a plan's QAPI program function, as proposed in 
paragraph (b)(5). States whose MLTSS programs include a self-direction 
option should consider including measures specific to self-direction 
under this paragraph.
    To streamline quality improvement standards for plans exclusively 
serving dual eligible beneficiaries, we proposed the option in 
paragraph (d)(3) for states to substitute an MA plan's quality 
improvement project conducted under Sec.  422.152(d) in the place of a 
Medicaid PIP. Finally, under proposed Sec.  438.330(e), states would 
continue annually to review the impact and effectiveness of each MCO's, 
PIHP's, and PAHP's quality assessment and improvement program. We also 
proposed that the state incorporate the results of any LTSS balancing 
efforts (community integration) at the managed care plan level into 
this program review. We requested comment on our approach to Sec.  
438.330.
    We received the following comments in response to our proposal to 
revise Sec.  438.330.
    Comment: Commenters supported retaining the standard from Sec.  
438.240, now outlined in Sec.  438.330(a)(1), that each MCO, PIHP, and 
PAHP establish and implement an ongoing comprehensive QAPI program for 
the services it furnishes to its enrollees.
    Response: We thank the commenters for taking the time to express 
their support and are retaining the standard outlined in Sec.  
438.330(a)(1) that each MCO, PIHP, and PAHP establish and implement an 
ongoing comprehensive QAPI program for the services it furnishes to its 
enrollees.
    Comment: CMS received many comments related to the proposed 
revisions in Sec.  438.330(a)(2). Many commenters supported the 
specification of a standardized set of performance measures and topics 
for PIPs for inclusion alongside state-specified measures and topics in 
state contracts with their MCOs, PIHPs, and PAHPs. Commenters noted 
that a common set of measures can enable comparison across states; 
better demonstrate trends; help establish national quality benchmarks; 
help CMS establish and monitor national priorities for health care 
improvement; and help spur innovation and sharing of best practices. 
Other commenters noted that standardizing the quality measures could 
help alleviate reporting burden (administratively and financially) for 
multi-state plans and allow plans as well as national health care 
organizations to focus resources on reducing wide variations and health 
disparities across states.
    Other commenters suggested that CMS recommend, but not require, 
specific performance measures and PIP topics. Some urged CMS to allow 
states to select a minimum number of measures from a required menu of 
measures issued by CMS in consultation with states and other 
stakeholders. The same menu approach was also suggested for PIPs. Other 
commenters recommended that CMS develop a set of minimum required 
measures from a larger menu of measures and allow for state-identified 
optional measures beyond the core. Other commenters expressed concern 
that states will require both their own and CMS' required measures and 
projects, which could result in burdening plans and providers. They 
therefore suggested that CMS require states to implement the CMS-
specified measures and projects or allow the state to propose an 
alternate set of measures and projects, subject to CMS approval. Some 
recommended that CMS identify high priority topics for PIPs, and offer 
technical assistance to states and plans around the implementation of 
these given topics.
    Response: We thank the commenters for their recommendations. We 
have flexibility under proposed Sec.  438.330(a)(2) to adopt the range 
of policies suggested by commenters, including identification of a 
common set of national QAPI performance measures and/or PIP topics for 
inclusion in state contracts with MCOs, PIHPs, PAHPs, and in the case 
of performance measures, PCCM entities (described in Sec.  
438.310(c)(2)). Should we elect to identify national performance 
measures and/or PIP topics for QAPI, we will provide additional 
guidance to states. We are finalizing this paragraph as it pertains to 
the potential identification of a common set of national QAPI 
performance measures and/or PIP topics with minor modifications for 
clarity. We note that in the final rule, this paragraph addresses only 
the selection of a common set of national QAPI performance measures 
and/or PIP topics; public engagement related to the QRS is addressed in 
Sec.  438.334 of the final rule.
    Comment: Several commenters expressed concern about the proposal in 
Sec.  438.330(a)(2) that CMS would specify performance measures, a 
methodology for calculating quality ratings, and topics with 
performance indicators for PIPs in state contracts with MCOs, PIHPs, 
and PAHPs, and recommended that states retain their current 
flexibility. Commenters expressed concern about the financial, 
administrative, measure collection, and reporting burden that this 
requirement could create for states, managed care plans, and providers. 
Some commenters expressed that their state's quality improvement system 
is working well and do not support the addition of quality metrics that 
may not align with the needs of the state. Others claimed that 
performance measures and PIPs are most effective when they are tailored 
to the unique issues and challenges in a specific state. One commenter 
opposed the CMS-specified measures and PIPs until more guidance is 
provided on the exemption process.
    Response: We appreciate the importance of state flexibility in 
meeting the needs of each state. However, we also recognize the 
potential value of specifying a common set of national QAPI performance 
measures and PIPs across states in the future, provided that there is a 
robust process for public input from states and other stakeholders in 
the identification of any such standards, as provided under proposed 
Sec.  438.330(a)(2) and finalized in this rulemaking. Further, 
regardless of the identification of any national performance measures 
or PIPs, states retain flexibility to select performance measures and/
or PIP topics in addition to those identified by CMS which meet the 
specific needs of the state (see Sec.  438.330(c) of the final rule).
    Comment: Commenters asked how often new performance improvement 
topics and measures will be identified as part of the specification of 
national QAPI measures and PIP topics, and how this process will 
influence the length of time that each PIP is implemented. Another 
commenter recommended that the implementation of the measures should be 
applied on a prospective basis to ensure all stakeholders have adequate 
lead time to fully understand the measure specifications, data 
collection methodology, and reporting strategy.
    Response: In section V.C.20 of the preamble (relating to the 
collection of information for Sec.  438.330), we estimate that CMS 
might identify national QAPI performance measures and/or PIP topics 
once every 3 years, but this is an estimate and no firm timeline 
exists. We agree that states will need adequate lead time prior to 
implementation. Should we pursue identification of national performance 
measures and/or PIP topics, we will use the public notice and comment 
process finalized in Sec.  438.330(a)(2) to consult with states and 
other stakeholders. For any nationally identified PIP topics, the

[[Page 27678]]

performance measures will be identified through a multi-stakeholder 
process similar to what occurs with the Core Set of Children's Health 
Care Quality Measures for Medicaid and CHIP (Child Core Set) and Core 
Set of Adult Health Care Quality Measures for Medicaid (Adult Core 
Set), collectively referred to as the CMS Child and Adult Core Measure 
Sets for Medicaid and CHIP. Details related to the implementation 
timeline would accompany any guidance relating to identified national 
performance measures and/or PIP topics.
    Comment: Another commenter sought clarification on whether the 
proposed rule relates to establishing national PIP topics only, or if 
the rule means that CMS might establish specific interventions to be 
implemented nationwide.
    Response: For a nationally identified PIP topic area, we expect 
that specific interventions will be chosen by the state or managed care 
plan.
    Comment: Commenters generally supported including a public notice 
and comment process in Sec.  438.330(a)(2), which would entail 
consultation with states and other stakeholders.
    Some commenters sought clarification related to the process. 
Commenters recommended that CMS describe in the regulation the process 
they will use for soliciting public comments, which should include an 
outreach and education component, a minimum comment period and minimum 
time periods for such comment periods, and requirements to include 
responses to public comments in subsequent drafts. Some commenters 
noted that the comment period should be a minimum of 60 days.
    Several commenters noted specific stakeholders and stakeholder 
groups that should be engaged, including states; patients and their 
families; consumer, LTSS, family caregiver, and health equity groups; 
MCOs, PIHPs, and PAHPs, including integrated Medicare-Medicaid Plans 
(MMPs) and dual eligible special needs plans (D-SNPs); the Aging 
Network sponsored by the Older Americans Act; and groups run by people 
with disabilities across multiple disability categories. Several 
commenters also suggested establishing a quality task force with 
balanced and meaningful representation from various advocates, Medicaid 
beneficiaries, and their families to increase stakeholders' awareness 
and expertise for future revisions of and additions to the core 
measures set. This could be achieved through regular required 
consultations with the state MCACs and, as applicable, LTSS stakeholder 
advisory groups. One commenter recommended that states be required to 
have a component of the public notice and comment process that is 
specific to children's health. Commenters also recommended that future 
notice and comment include discussions on setting improvement targets, 
in addition to focusing on selecting metrics.
    Finally, commenters requested additional information related to the 
public notice and comment process for the MMC QRS.
    Response: In Sec.  438.330(a)(2), we proposed ``a public notice and 
comment process'' to ensure that states, beneficiaries, and other 
stakeholders had the opportunity to provide input should we choose to 
specify national QAPI performance measures and improvement projects. To 
ensure broad participation, if we exercise the authority under Sec.  
438.330(a)(2), we will publish a public notice in the Federal Register.
    As discussed in section I.B.6.b(2)(e) of this preamble, we are 
finalizing the public engagement process for the MMC QRS in Sec.  
438.334, rather than in Sec.  438.330(a)(2) as was proposed. Please see 
section I.B.6.b(2)(e) below for additional discussion of the MMC QRS 
public engagement process.
    Comment: Several commenters recommended that Sec.  438.330 be 
revised to require states to engage in a public comment process during 
their managed care contract development activities, noting that 
stakeholders must have the opportunity to evaluate and comment on the 
state's proposed quality improvement plan, as well as individual 
managed care plans' proposed activities to meet quality improvement 
requirements.
    Response: We decline the suggestion to require states to engage in 
a public process regarding QAPI during the managed care contract 
development process under Sec.  438.330. The required elements for a 
state's quality strategy, finalized at Sec.  438.340(b), must address 
the state's plans for performance measurement and PIPs in QAPI; this 
document, per Sec.  438.340(c), is subject to a public engagement 
process, and thus will afford the public an opportunity to comment on 
the state's quality improvement plans.
    Comment: Several commenters recommended that the final rule provide 
more detail on the federal process for stakeholder engagement and 
public input specifically for identifying federal standards for the 
Medicaid and CHIP managed care quality rating system, so that 
stakeholder engagement is not ``lost in the planning process.'' Other 
commenters recommended that the process be rigorous, and the final rule 
should enumerate expected outcomes of the process. Several commenters 
also recommended that CMS model this process after the transparency and 
public engagement requirements for the section 1115(a) demonstration 
approval process.
    Several commenters requested that CMS include a consensus-building 
working group to support the identification of federal standards for 
the MMC QRS. Commenters made various recommendations for participants 
in the work-group or in the stakeholder engagement process including 
plans, state officials, advocacy groups and coalition groups, consumer 
advocates or other stakeholders. Some commenters additionally 
recommended that CMS should include a transparent, public application 
process for identifying working group members. One commenter requested 
that CMS define ``meaningful input,'' and clearly describe how many and 
which organizations will participate, how often they should meet, and 
what their roles should be.
    One commenter recommended that the states should be the primary 
partners in the development of a MMC QRS(Sec.  438.334) because states 
are the only ``equity stakeholder'' and have critical experience that 
should inform the practicality and utility of such systems as they 
understand the fundamental differences between programs and 
populations. The commenter believed that this would be imperative if 
CMS does not provide clear guidance for states to develop and use their 
own system.
    Response: We thank the commenters for their input. We are removing 
the reference to the MMC QRS methodology from Sec.  438.330(a)(2) and 
adding language to Sec.  438.334 to address the public notice and 
comment process for developing federal standards for the MMC QRS.
    Comment: Several commenters supported allowing states to select 
additional measures beyond those in the CMS-specified set to report, as 
described in Sec.  438.330(a)(2)(i) of the proposed rule. One commenter 
noted that this is particularly important for states that contract with 
MCOs offering FIDE SNPs and D-SNPs. Another commenter offered specific 
criteria states should use when selecting additional measures, 
specifically whether the measures: (1) Are endorsed by a multi-
stakeholder, evidence-based quality organization; (2) reflect higher 
performance in helping to achieve patient-centered outcomes; (3) are 
based on evidence-based processes or

[[Page 27679]]

outcomes; and (4) are aligned across multiple care settings and 
providers. One commenter recommended that CMS specify in regulation how 
states must engage with stakeholders and incorporate public comment 
into plans and assessments as it relates to Sec.  438.330(a)(2)(i) of 
the proposed rule.
    Response: We thank the commenters for taking the time to express 
their support. Regardless of whether CMS identifies a common set of 
national QAPI performance measures and PIP topics pursuant to Sec.  
438.330(a)(2), states are required to identify performance measures and 
PIPs which their contracted MCOs, PIHPs, PAHPs, and in the case of 
performance measures, PCCM entities (described in Sec.  438.310(c)(2)), 
must include in each plan's QAPI program. This requirement, and its 
inherent flexibility for states to identify performance measures and 
PIPs which go beyond those which may be specified by CMS, was expressed 
in proposed Sec.  438.330(a)(2)(i). Under the final rule, we have 
codified this requirement in Sec.  438.330(c) and (d) and therefore 
have removed Sec.  438.330(a)(2)(i) as its presence would be redundant 
in light of the revisions to Sec.  438.330(c) and (d) of the final 
rule. We encourage states to engage a broad range of stakeholders in 
the selection of additional measures and projects but do not believe it 
is appropriate to further regulate that process.
    Comment: Commenters requested that CMS support measure alignment 
and harmonization, including alignment across Medicaid managed care and 
FFS, with other markets (for example, Medicare, MA, QHPs in the 
Marketplace), and among payers in a state, and rely on existing 
national endorsed measures, measure sets, and other federal measurement 
frameworks (for example, National Quality Strategy) and initiatives 
(for example, Meaningful Use) when identifying the common set of 
national QAPI performance measures. A commenter noted that CMS should 
provide sufficient flexibility to allow states to align measures with 
other payers, as appropriate. Other commenters noted that any measures 
should take into account the resulting implications on providers and 
ensure that they take into account unique provider types and 
populations.
    Several commenters recommended that all national QAPI measures be 
endorsed by the National Quality Forum (NQF). Several commenters 
recommended using the Measure Applications Partnership convened by NQF 
as part of the measure selection and measure gap identification 
process; selecting quality metrics that are developed by national 
standard-setters, such as the National Committee for Quality Assurance 
(NCQA), including HEDIS measures; and aligning with the 15 improvement 
areas identified in the Institute of Medicine's Vital Signs: Core 
Metrics for Health and Health Care Progress report. Other commenters 
recommended the greater integration and adoption of the CMS Child and 
Adult Core Measure Sets for Medicaid and CHIP and the lessons learned 
from the Pediatric Quality Measures Program. Commenters also encouraged 
the adoption of measures that are common to both providers and plans.
    To help alleviate measure collection and reporting burden, another 
commenter recommended harmonizing physician-related measures with 
existing programs such as the Physician Quality Reporting System or the 
NCQA Patient Centered Medical Home standards and streamlining reporting 
and utilization standardized reporting tools and metrics. Another 
commenter encouraged CMS to support HIV measure reporting alignment, 
consistent with the HIV Care Continuum Initiative. They recommended 
using the HIV Medicine Association's compilation of existing quality 
measures as a guide.
    Another commenter suggested CMS consider a comprehensive review of 
both Medicare and Medicaid measures applied to integrated programs 
serving dually eligible beneficiaries and of issues that are of unique 
importance to producing quality outcomes for these populations. Lastly, 
one commenter also recommended that CMS strive to align not only the 
measures used for evaluating quality in Medicare and Medicaid, but also 
their timelines for reporting the data underlying those measures.
    Response: We appreciate the importance of measure harmonization and 
alignment and the need to minimize measurement burden as much as 
possible; these are considerations in all of our performance 
measurement activities. Should we elect to identify national 
performance measures under the authority of Sec.  438.330(a)(2) of the 
final regulation, we will take these recommendations into consideration 
during the public notice and comment process.
    Comment: Several commenters noted the need for measures that are 
sensitive to the differences in populations served. Commenters noted 
the need to consider risk adjustment and/or stratification of the 
national QAPI performance measures to account for patient acuity, 
frailty, and/or socio-demographics. Another commenter recommended that 
CMS seek comment on risk adjustment factors and methodologies specific 
to the Medicaid population. One commenter noted that any set of 
measures should include comparable patient characteristics (that is, 
apples to apples comparison) and recommend that CMS construct pediatric 
age subcategories that at least separates individuals 18 years and 
under into a category apart from the adult population. One commenter 
sought a specific methodology for U.S. territories that would take into 
account factors that influence quality metrics.
    Response: We thank the commenters for their recommendations and 
will take these considerations into account during the public notice 
and comment process should we elect to identify national performance 
measures per Sec.  438.330(a)(2) of the final regulation. Note that 
standards for risk adjustment are provided in Sec. Sec.  438.5(g) and 
438.7(b)(5).
    Comment: One commenter noted that the proposed rule did not specify 
that quality reporting, measurement, and oversight should be conducted 
specifically on a managed care plan's Medicaid line of business. The 
commenter requested that CMS clarify in the regulations that any 
quality monitoring be evaluated specifically on a plan's Medicaid 
network(s) and not on non-Medicaid networks or the networks used by 
some or all of their other products (such as those in Medicare 
Advantage, Marketplace, and the private market).
    Response: Section 438.1(b) of the final rule identifies the scope 
of part 438, which applies to the provision of Medicaid services 
through MCOs, PIHPs, PAHPs, PCCMs and PCCM entities. Therefore, the 
quality provisions in part 438 subpart E apply to Medicaid services 
provided via managed care plans, as described therein. The PIPs and 
performance measures, in Sec.  438.330(b)(1) and (b)(2) respectively, 
must be specific to a managed care plan's Medicaid beneficiaries 
(including dual eligibles, if served by that plan). While a managed 
care plan could use the same intervention across its lines of business 
to drive improvement, and the same measures across its lines of 
business to assess performance, those reported to the state and in turn 
included in the annual EQR must be specific to the Medicaid managed 
care population and must be consistent with the requirements under the 
Medicaid regulations.
    Comment: Several commenters sought clarification on how the state-
selected performance measures and PIP topics described in Sec.  
438.330(a)(2)(i) of the

[[Page 27680]]

proposed rule relate to the state-selected measures specific to the 
proposed comprehensive quality strategy requirements in proposed Sec.  
431.502(b)(2). Commenters sought clarification on whether the national 
measures selected under QAPI would apply in the Medicaid FFS context, 
given that the comprehensive quality strategy in the proposed new 
subpart I of part 431 would apply statewide across delivery systems.
    Response: We thank the commenters for their questions. 
Preliminarily, we note that we are withdrawing our proposal for a 
comprehensive quality strategy as under part 431 subpart I of the 
proposed rule (see section I.B.6.b.(2)(f) below). Section 438.330 
applies specifically to Medicaid managed care plans. Medicaid FFS is 
not required to participate in a QAPI program, although states may 
elect to integrate their quality improvement efforts across delivery 
systems.
    Comment: Commenters requested that CMS consider various principles 
as well as important populations and topic areas as part of the design 
of the QAPI program, specifically when selecting the national QAPI 
performance measure and PIP topics. Specific principles that commenters 
recommended CMS consider when selecting performance measures include 
focusing on inclusive, high-value measures that are useful in national 
comparisons and also actionable for quality improvement, and limiting 
the number of required performance measures and PIPs. Commenters also 
recommended incorporation of principles specific to pediatric 
populations, including replacing less impactful measures with validated 
measures coming out of the PQMP and other relevant sources and ensuring 
a pipeline of much needed pediatric quality of care and outcomes 
(health and cost) measures.
    Commenters recommended several populations that require 
consideration, for example, pediatric populations, including children 
with complex conditions; Native Americans and Alaska Natives; persons 
with degenerative conditions, such as Alzheimer's Disease or dementia; 
persons with HIV/AIDS; and persons with serious mental illness or 
substance use disorders.
    Commenters offered a range of measurement topics for CMS to 
consider when selecting the national QAPI performance measures, 
including but not limited: to measures focused on access to care, and 
certain subpopulations' access to medically necessary treatment for 
specified conditions; measures that address health care disparities; 
meaningful outcomes of clinical care; patient-and caregiver-reported 
measures of outcomes; care experience and functional status; over-and 
under-utilization; person-centeredness; consumer's individual 
preferences and goals; patient activation scores or other similar 
measurements; quality outcomes beyond medical ones, specifically 
quality of life; screening; prevention and disease management for 
dental caries in children (specifically the measure set developed by 
the Dental Quality Alliance); behavioral health care; medication 
adherence; preventable events, including ambulatory-sensitive 
admissions, readmissions, preventable ER visits and hospital 
complications; effective management of HIV, in addition to routine HIV 
screening and viral load suppression; screening for exposure to 
intimate partner violence among pregnant woman; health and coordination 
across the continuum (specifically NQF-endorsed measures); social 
determinants of health care (specifically IOM metrics); and care 
coordination for the chronically ill.
    Commenters also offered PIP topics for CMS to consider, including 
but not limited to improving population health; reducing adverse drug 
events, particularly in high-risk populations and high-risk therapeutic 
classes; and utilization of childbirth education. Commenters noted that 
CMS should choose PIPs that are broadly applicable to all states, are 
clearly important issues for improvement, can be aligned with other 
payers, and can have an impact.
    Response: We thank the commenters for their input and will take 
these considerations into account as a part of the public notice and 
comment process should we elect to identify national performance 
measures and/or PIP topics per Sec.  438.330(a)(2) of the final 
regulation.
    Comment: One commenter encouraged CMS to apply the same measures 
used to assess dental PAHPs to MCOs that include dental services. Other 
commenters supported not requiring dental PAHPS to report the national 
QAPI performance measures in recognition that there are unique dental 
quality measures and that ``medical'' quality measures are not workable 
for dental plans.
    Response: We thank the commenters for their input. Should we 
utilize the authority under Sec.  438.330(a)(2) of the final 
regulation, CMS will work with stakeholder groups through a public 
engagement process to ensure requirements issued for plans are 
appropriate. We do not intend to require specialized plans to report 
measures outside their specialized area. In the case of an MCO which 
provides dental services, if we were to identify dental performance 
measures we would require the MCO to report on those dental measures, 
along with any identified medical measures. Our intent is to apply 
measures to managed care plans which are appropriate to the services 
provided by the plan.
    Comment: Several commenters urged HHS to ensure that states develop 
quality measurement programs with the capacity to evaluate health 
disparities and take the necessary steps to eliminate them. One 
commenter recommended that CMS require states to ensure, through their 
contracts with managed care entities, that managed care entities 
collect and submit performance data related to clinical outcomes for 
specified subpopulations and annually report to the state on health 
outcomes for subpopulations and minorities. Another commenter 
recommended that CMS improve data collection and reporting by requiring 
states in contracts with plans to include data stratified by race, 
ethnicity, primary language, gender identity and sexual orientation for 
measuring success. They recommended that CMS reinforce the data 
collection requirements under section 4302 of the Affordable Care Act 
by offering a financial incentive for improved data collection, and 
require plans to use the NQF consensus measures to assess cultural 
competency and language services. Another commenter recommended adding 
sexual orientation and gender identity to the list of areas that the 
Affordable Care Act requires any federally conducted or supported 
health care or public health programs, activities or surveys to collect 
and report data on.
    Response: We thank the commenters for their input. As documented in 
a November 2014 Report to Congress on Improving the Identification of 
Health Care Disparities in Medicaid and CHIP, HHS has made progress in 
addressing health care disparities in Medicaid and CHIP by updating 
data-collection systems and tools; stratifying performance measures by 
demographic characteristics; developing new measures specific to 
populations of interest; and promoting data sharing, collaboration, and 
analyses. To improve upon these efforts, the report recommends 
improving upon the quality of health care disparities data across 
delivery systems, and the completeness of health care disparities data 
collection in managed care. We are committed to these efforts in 
partnership with states and other

[[Page 27681]]

stakeholders; to this end, under this final rule states will have to 
require their plans to address health disparities in their Medicaid 
managed care quality strategies consistent with Sec.  438.340(b)(6) of 
the final rule.
    Comment: One commenter sought clarification related to the data 
collection and submission process for the national QAPI performance 
measures. They noted the importance of reporting data consistently and 
recommended that the expectations for the quality of data submitted 
should be strengthened. Another commenter noted that metric collection 
should complement current reporting pathways, and leverage existing 
information technology and clinical decision support systems.
    Response: We thank the commenters for their input. CMS recognizes 
the importance of collecting data consistently and is working to ensure 
that quality data is collected.
    Comment: Some commenters supported the process outlined in proposed 
Sec.  438.330(a)(2)(ii) that would allow for states to request an 
exemption from nationally identified performance measures and PIP 
topics. Commenters noted the mechanism for exemption would allow states 
to tailor their quality assessment processes to their specific 
populations, and allow states to innovate and respond to their unique 
aspects of their program.
    Response: We thank the commenters for taking the time to express 
their support. We are finalizing this provision as proposed with non-
substantive revisions for clarity. It can be found in Sec.  
438.330(a)(2) of the final regulation.
    Comment: Many commenters provided input on the examples of 
exemptions outlined in the preamble, and offered additional 
recommendations or clarification. Many commenters agreed that states 
should be exempt from reporting measures that are not applicable to the 
population enrolled in Medicaid managed care in their state or that 
relate to the quality of a service not covered by or relevant to the 
managed care contract.
    Some commenters urged CMS to limit the reasons for which a state 
could seek an exemption. While commenters recognize that flexibility 
would let states meet their own needs, it could lead to less alignment 
between states and potentially minimize transparency and stakeholder 
engagement efforts. Commenters suggested that CMS provide strict 
guidance to states regarding the removal of state-specific measures 
that overlap or conflict with the standard set of measures issued by 
CMS. Some commenters recommended enumerating a set of specific reasons 
that would justify a state obtaining an exception and some encouraged 
CMS to allow states to receive exemptions only if the measure is not 
applicable to the covered population or if the measure is only relevant 
to a service or services not covered in the MCO contract. Others 
recommended that states with an exemption should still be required to 
gather data and report on quality metrics. One commenter recommended 
that the exemption process include specific pediatric components. 
Commenters also suggested setting time limits on how long an exemption 
could last without review and some commenters recommended establishing 
a 2-year time limit for exemptions.
    Several commenters agreed with exempting states if the number of 
enrollees is too small to calculate a measure. One commenter suggested 
that exemptions within states be allowed for plans that serve specialty 
populations (for example, recipients with HIV/AIDS, or dual eligibles) 
that may not have sufficient numbers of eligible members for the 
required PIP topic indicators. Another commenter recommended that CMS 
specify in regulation or sub-regulatory guidance how small a measure 
population must be to not be meaningful. The commenter recommended that 
a minimum of 30 enrollees is a sufficient size to be valuable and 
meaningful.
    Some commenters recommended allowing a state to seek an exemption 
if the state already meets and exceeds a performance threshold. Other 
commenters disagreed with allowing a state to seek an exemption if it 
surpasses a performance threshold for multiple years. They stated that 
thresholds are not always accurate measures of quality for states, 
especially for subpopulations, and granting such an exemption could 
allow for deterioration in performance after the exemption is granted. 
Several commenters noted that performance in the 90th percentile for 
more than 3 years, as suggested in the preamble, would not be 
attainable for even the highest performing plans. They also noted that 
for many measures, such as certain vaccinations or the frequency of 
``never events,'' a threshold of 90 percent would not be considered 
successful. Commenters stated that allowing for an exemption may 
undermine HHS' broader efforts to identify and reduce health 
disparities across key demographic groups. If CMS permits exemptions 
based on sustained achievement, the thresholds must be appropriate for 
each measure and states should have to prove that no significant 
disparities exist for key demographic groups prior to receiving a time-
limited exemption.
    Some commenters noted that CMS did not explicitly identify examples 
of exemptions that would apply to the federally-identified PIP topics 
in the preamble and request that a clear exemption process be 
established for PIPs as well. Other commenters recommend that states be 
permitted, on an ongoing basis, to put forward a justification for 
other cases where an exemption would be warranted.
    Response: We thank the commenters for their recommendations. While 
we are committed to ensuring robust performance measures are 
implemented in all states, we cannot anticipate all of the 
circumstances which may justify an exemption for a national performance 
measure or PIP topic. Therefore, we believe it is important to retain 
flexibility in the regulations and are finalizing proposed Sec.  
438.330(a)(2)(ii) with non-substantive revisions for clarity. This 
provision is now codified as part of Sec.  438.330(a)(2) in the final 
regulation.
    Comment: One commenter sought clarification as to whether a state 
could request an exemption for some, but not all, of the plans in the 
state (that is, only exempting those plans in their state that perform 
consistently well). This commenter suggested that CMS develop a state-
dedicated technical assistance process, through which states could show 
what they have in place for various measures, PIPs, and processes, and 
receive guidance on how closely they match what CMS proposes.
    Response: We thank the commenters for their input. We plan to issue 
future guidance, after consultation with states and stakeholders, 
related to the exemption process for performance measures and PIPs 
pursuant to Sec.  438.330(a)(2) of the final regulation.
    Comment: A few commenters made suggestions intended to ensure MCOs 
deliver high-quality, high-value care to patients and achieve contract 
goals in a fiscally responsible manner. One commenter urged that 
managed care entities be required to: Establish mechanisms to 
incorporate feedback from enrollees and providers; monitor and evaluate 
high-volume and high-risk services and the care of acute and chronic 
conditions; evaluate the continuity and coordination of care that 
enrollees receive; have mechanisms to detect both underutilization and 
overutilization of services; use systematic data collection of 
performance and patient results, provide interpretation of these data 
to their practitioners, and make needed changes indicated by the data; 
and make

[[Page 27682]]

available information on quality and outcomes measures to facilitate 
beneficiary comparison and choice of health coverage options. Another 
commenter encouraged CMS to detail the variety of opportunities for 
states to utilize mobile healthcare tools to improve their care 
coordination efforts for Medicaid recipients with major mental health 
and addiction disorders.
    Response: We thank the commenters for their recommendations. We 
note that some of the recommendations already are incorporated into the 
final rule. Sections 438.330(b)(1) and (2) require performance 
measurement and PIPs; Sec.  438.330(b)(3) requires QAPI to include 
mechanisms to detect underutilization and overutilization of services; 
and Sec.  438.330(b)(4) requires mechanisms to assess the quality and 
appropriateness of care provided to enrollees with special health care 
needs. While we decline to incorporate the commenters' other 
suggestions into the final rule, we encourage commenters to work with 
CMS and states through future public engagement processes.
    Comment: One commenter noted their support for requiring PCCM 
entities to establish and maintain mechanisms to detect over- and 
under-utilization of services under Sec.  438.330(b)(3) because such 
mechanisms can be important in detecting misuse, identifying access 
barriers, and evaluating network adequacy. Another commenter asked for 
clarification regarding the application of proposed Sec.  438.330(b)(3) 
to PCCM entities, specifically if the mechanisms to detect 
underutilization and overutilization of services refers to case 
management services or medical services, or if the focus will be 
determined at the state level.
    Response: Section 438.330(b)(3) requires comprehensive QAPI 
programs to include mechanisms to detect underutilization and 
overutilization of services. The services referenced include medical 
services only, not case management services. This means that PCCM 
entities (described in Sec.  438.310(c)(2)) that are subject to Sec.  
438.330(b)(3) and are responsible for managing the care of their 
beneficiaries must assess whether beneficiaries are receiving timely 
access to appropriate medical services.
    Comment: One commenter suggested that quality review of 
overutilization of services under Sec.  438.330(b)(3) should include 
the ``Choosing Wisely'' components.
    Response: We do not believe that it is appropriate to identify 
specific requirements for the overutilization review process used by 
managed care plans in the regulations and are not doing so in this 
rulemaking.
    Comment: One commenter noted their support for Sec.  438.330(b)(6) 
but expressed concern that there is no national standard for the 
definition of the term ``critical incidents.'' They recommended that 
CMS adopt a definition from MA or NCQA, if available.
    Response: We thank the commenter for their support. Per Sec.  
438.330(b)(5)(ii) in the final rule, MCOs, PIHPs, or PAHPs providing 
LTSS should at a minimum base their efforts to prevent, detect, and 
remediate critical incidents (consistent with assuring beneficiary 
health and welfare per Sec. Sec.  441.302 and 441.730(a)) on the 
requirements on the state for home and community-based waiver programs 
per Sec.  441.302(h).
    Comment: One commenter sought clarification related to the phrase 
``reasonable time period'' (in proposed Sec.  438.330(d)(2)) for 
completion of a PIP.
    Response: We thank the commenter for their question. Proposed Sec.  
438.330(d)(2) is finalized at Sec.  438.330(d)(3), with revision. Per 
section Sec.  438.330(d)(3) of the final rule, the state must require 
each MCO, PIHP, and PAHP to report the status and results of each 
project to the state as requested, but not less than once per year. CMS 
intends to release future guidance in its EQR protocols (see Sec.  
438.352) to support states in their efforts to implement and report on 
the effectiveness of PIPs.
    Comment: Several commenters supported the option in proposed Sec.  
438.330(d)(3) for states to substitute an MA plan's quality improvement 
project conducted under Sec.  422.152(d) in the place of a Medicaid 
PIP. Commenters noted that this alignment is beneficial for dual 
eligibles and the entities that offer FIDE SNPs and D-SNPs, and creates 
streamlined efficiencies for issuers and providers, which will 
contribute to consistent care.
    Response: We thank the commenters for taking the time to express 
their support. We are finalizing proposed Sec.  438.330(d)(3) with non-
substantive revisions for clarity. This provision can be found at Sec.  
438.330(d)(4) of the final regulation.
    Comment: Some commenters expressed concern that allowing MCOs, 
PIHPs, and PAHPs serving only dual eligibles to substitute MA 
organizational quality improvement projects will reduce the likelihood 
of LTSS related PIPs. One commenter opposed this provision, stating 
that MA does not typically cover LTSS, so this could lead to excluding 
LTSS from improvement projects. Commenters recommend that plans 
substituting MA quality improvement projects should ensure that LTSS 
related PIPs are included based upon input from a member advisory 
committee.
    Response: First, we note that the decision to substitute an MA QIP 
for a Medicaid PIP for a plan serving exclusively dual eligibles lies 
with the state, not with the managed care plan. Thus, it is the state, 
not the plan, that will determine if this option best will serve its 
dual eligible beneficiaries. Second, election to use an MA QIP for a 
plan serving only dual eligibles does not relieve states of their 
responsibility to require plans to conduct PIPs that involve both 
clinical and nonclinical areas, which could include LTSS, under Sec.  
438.330(d) as finalized in this rulemaking. Further, plans providing 
LTSS services will be required, per Sec.  438.330(c)(1)(ii) of the 
final rule, to measure LTSS performance. We believe that these measures 
will drive plans to engage in efforts to improve the quality of care 
for LTSS services.
    Comment: Several commenters sought clarification related to the 
option in proposed Sec.  438.330(d)(3) (re-codified as Sec.  
438.330(d)(4) in this final rule). One commenter noted the need for 
timely and complete Medicare data and recommended that CMS make timely 
and complete data on Medicare utilization available to states to aid 
quality projects relating to dual-eligible populations. Making this 
data available to EQROs would provide an immediate, likely cost-
effective benefit to both Medicaid and Medicare. Another commenter 
noted that some Medicaid D-SNPs may not exclusively serve dually-
eligible individuals. They recommended that states with plans that are 
D-SNPs and also serving other Medicaid beneficiaries be able to use a 
MA quality improvement project in place of a Medicaid PIP. Another 
commenter recommended that CMS establish standards across states rather 
than allowing states to choose which PIPs are adhered to by MCOs 
exclusively serving the dual eligible population.
    Response: We believe that all populations served by a plan should 
receive the benefit of PIPs. Therefore, we are not accepting the 
recommendation to apply the option now codified at Sec.  438.330(d)(4) 
to plans that serve Medicaid beneficiaries who are not dually eligible 
for Medicare, even if they serve a significant number of dually-
eligible beneficiaries. However, nothing in this rule prevents a plan 
that serves a significant number of dual eligibles from focusing on the 
same topic for both a QIP and PIP, nor

[[Page 27683]]

from using the same interventions for a QIP and PIP, provided that the 
PIP and associated interventions meet the requirements set forth in the 
regulation.
    Comment: CMS received many comments related to the revisions in 
proposed Sec.  438.330(b)(5), relating to the assessment of quality and 
appropriateness of care to enrollees in LTSS in the QAPI program. Many 
commenters supported the inclusion of LTSS in state QAPI programs and 
the identification of mechanisms to assess the quality and 
appropriateness of care furnished to enrollees using LTSS. One 
commenter opposed including LTSS in the state QAPI program for managed 
care noting that enrollees using LTSS have different care needs, thus 
necessitating different efforts to measure the adequacy, 
appropriateness, and success of LTSS programs.
    Response: We thank the commenters for their support. We note that 
under the proposed rule the inclusion of LTSS in the QAPI program would 
expand the program review from a single focus on acute care services, 
making it more comprehensive and valuable. We believe that performance 
measurement activities for LTSS that are similar to those for other 
managed care systems are appropriate and important to ensuring that 
efforts to drive improvements in the quality and appropriateness of 
care in LTSS are comparable to those related to other care and 
services. Additionally, quality measurement and improvement tools for 
LTSS are now underway within and across multiple HHS agencies and 
components. As a result, we are finalizing proposed Sec.  438.330(b)(5) 
(redesignated at Sec.  438.330(b)(5)(i) in the final regulation) with 
minor non-substantive revisions for clarity.
    Comment: One commenter supported requirements to ensure that 
mechanisms are in effect to have managed care plans compare service and 
supports that an individual is receiving relative to the individual's 
LTSS treatment or service plan and suggested requirements for reporting 
frequency and public reporting under proposed Sec.  438.330(b)(5).
    Response: We appreciate support in proposed Sec.  438.330(b)(5) for 
the requirement that states ensure that plans assess the services an 
individual is receiving as compared to the services identified in the 
individual's LTSS treatment or service plan. We are retaining this 
provision at Sec.  438.330(b)(5)(i) of the final rule. We are not 
adding any reporting requirements to Sec.  438.330(b)(5); such 
requirements were addressed in proposed Sec.  438.330(c), under which 
each MCO, PIHP, PAHP, or PCCM entity (as described in Sec.  
438.310(c)(2)) is required annually to measure and report to the state 
annually its performance using standard measures.
    Comment: A few commenters recommended that states be allowed to 
determine the process to assess the quality and access to care in LTSS. 
One commenter stated that this would allow states to align LTSS quality 
activities with other quality initiatives which are already in place in 
the state.
    Response: We thank the commenters for their concern and 
recommendations. We believe that the proposed rule provides a broad 
framework for states to utilize in assessing the quality and 
appropriateness of care in LTSS, and that this framework allows states 
the flexibility to align their quality initiatives (where appropriate), 
strengthen quality efforts, and prevent duplication of effort.
    Comment: Several commenters recommended that CMS require states to 
include measures specific to self-direction when an MLTSS program 
includes self-direction per proposed Sec.  438.330(b)(5). A couple of 
commenters cited HHS guidance identifying potential concerns and 
opportunities related to self-direction as states expand Medicaid 
managed care.
    Response: We thank the commenters for their input. While we 
encourage states where MLTSS programs include a self-direction option 
to consider including measures specific to self-directed service 
delivery, CMS currently gives states the flexibility to identify 
specific measures to monitor performance. As such, we decline to make 
such measures a requirement for QAPI.
    Comment: Several commenters specifically stated that they supported 
the revisions in proposed Sec.  438.330(c)(4) regarding additional 
quality and performance measurement activities required for LTSS.
    Response: We thank the commenters for their support. We are 
finalizing proposed Sec.  438.330(c)(4) with non-substantive revisions 
for clarity. This provision can be found in Sec.  438.330(c)(1)(ii) of 
the final regulation.
    Comment: CMS received many comments related to proposed Sec.  
438.330(c)(4). Many commenters suggested additional required 
performance measures, in addition to those outlined for assessing LTSS. 
Several commenters suggested that the required performance measures 
also include care coordination, the needs assessment process, and self-
direction in states that implement this option. Several other 
commenters recommended that required performance measurement activities 
for LTSS also include additional specific clinical areas such as: 
Quality of life, transfer of care, person-centered elements, and 
rebalancing and community integration activities. Several other 
commenters recommended that non-medical measures be added to the list 
of required measures including: Adequacy of the direct care workforce; 
consumer grievances and appeals; number of cases of neglect or abuse; 
number of cases involving a denial or reduction in services; and 
achievement of equality of opportunity, independent living, economic 
self-sufficiency and full participation as defined in the ADA.
    Response: We appreciate the commenters concerns and input, and 
thank the commenters for the suggestions regarding required performance 
measurement activities and areas of measurement. We are finalizing 
Sec.  438.330(c)(4) as Sec.  438.330(c)(1)(ii) of the final regulation. 
While the state must identify performance measures relating to quality 
of life, rebalancing and community integration activities for 
individuals receiving LTSS, the state may elect to identify additional 
LTSS-focused areas of measurement for MCOs, PIHPs, or PAHPs providing 
LTSS services. CMS will also take these considerations into account as 
part of the public notice and comment process per Sec.  438.330(a)(2) 
of the final regulation should we elect to identify national 
performance measures under this authority. Additionally, we note that 
the Department of Health and Human Services, including CMS, is working 
with the NQF to further performance measurement activities in the areas 
of home and community-based services, person and family-centered care, 
dual eligible beneficiaries, and other areas that impact Medicaid MLTSS 
enrollees.
    Comment: Several commenters supported the requirements outlined in 
Sec.  438.330(c)(4), which they noted would help advance better and 
more comprehensive metrics for LTSS, but believed that there is a need 
for further development of performance measures in the area of LTSS. A 
few commenters recommended that quality measurement activities be 
developed to evaluate the needs and utilization patterns in LTSS for 
persons with behavioral health needs as well as metrics appropriate for 
persons with physical, intellectual and other disabilities. 
Additionally, several commenters supported the use of interim measures 
until an adequate number of validated measures are available. One 
commenter noted that the

[[Page 27684]]

use of interim measures will help support the quality and availability 
of LTSS, pending formal validation of additional LTSS measures. These 
commenters also recommended that CMS build out or adopt measures that 
already are in development through a national consensus-based approach 
and ensure that any LTSS measure used for Medicaid is both feasible and 
replicable.
    Several commenters recommended that LTSS performance measurement 
activities be developed and implemented in alignment with other CMS 
quality initiatives. One commenter recommended that efforts should 
align with MA, private market, and Medicaid requirements and quality 
measurements, and that organizations who care for dual eligibles be 
subjected to same quality measures as MA, such that comprehensive care 
is coordinated and administrative burden is lessened.
    Several commenters requested a delay or flexibility in the 
implementation of performance measurement and assessment activities 
until appropriate quality metrics for LTSS are developed and endorsed. 
One commenter stated that national quality and performance measurement 
for LTSS is not as well-developed as it is for medical services and 
noted reservations about the robustness, validity, and reliability of 
LTSS measures at this time. A couple of commenters requested that the 
agency delay the implementation of this requirement until national 
accrediting bodies and other stakeholders are able to establish a 
meaningful set of quality measures for use. One commenter stated 
concerns that managed care plans will not be able to meet the QAPI 
program regulations because of the lack of robust and comprehensive 
LTSS quality measures and performance assessment tools.
    Response: We thank the commenters for their feedback and concerns 
regarding the status of measure development in LTSS and for 
recommendations regarding the use of interim measures and areas for 
future measure development. To better understand the landscape in 
quality measurement for LTSS and HCBS, HHS and CMS have been working 
with contractors, state and other federal partners, and external 
stakeholders on several measurement initiatives:
     Risk- and reliability-adjustment models for three 
composite measures for HCBS after identifying potentially avoidable 
hospital admissions as an important quality measurement domain for 
individuals receiving HCBS.
     The NQF convened a multi-stakeholder group in 2014 to 
conduct a measure gap analysis and develop recommendations for 
performance measurement to address person- and family-centered care. 
Specific recommendations focused on patient-centered communications; 
shared decision making; the concordance of care plans with individual 
preferences, values, and goals; and measures based on patient-reported 
outcomes. NQF's Measure Applications Partnership (MAP) also convened a 
time-limited task force in 2014, drawn from the membership of the MAP 
Coordinating Committee and four advisory workgroups, to identify a 
family of measures focused on person- and family-centered care. 
Families of measures are sets of related available measures and measure 
gaps that span programs, care settings, levels of analysis, and 
populations.
     NQF is currently working on a similar effort to address 
the gaps in HCBS measures through a multi-stakeholder process to 
consider the definition of home and community-based services (for the 
purposes of this project), develop a conceptual framework using domains 
for measurement, and make recommendations for HCBS measurement 
development.
     The Experience of Care (EoC) Survey elicits feedback on 
beneficiaries' experience with the services they receive in Medicaid 
community-based LTSS programs. In addition to the survey, the 
electronic Long-Term Services & Supports (eLTSS) Initiative is an 
Office of the National Coordinator for Health Information Technology 
(ONC)-CMS partnership focused on identifying and harmonizing electronic 
standards that can enable the creation, exchange and re-use of 
interoperable service plans for use by providers of both health care 
and home and community-based services, payers, and beneficiaries. Both 
of these initiatives are driven by the requirements of the CMS Testing 
Experience and Functional Tools (TEFT) Planning and Demonstration Grant 
Program funded by the Affordable Care Act.
     The Medicare-Medicaid Coordination Office is working 
across CMS to further efforts related to LTSS measure development and 
endorsement.
    We agree with aligning with existing programs and measurements when 
possible for ease of measurement and burden reduction, and we will 
continue to look for opportunities for alignment and burden reduction.
    We may issue additional information on LTSS performance measurement 
through subregulatory guidance.
    Comment: Several commenters recommended that a beneficiary survey 
be a required element in the QAPI to assess the quality and 
appropriateness of care furnished to enrollees using LTSS. 
Additionally, several commenters recommended that family caregivers (if 
applicable) should also be surveyed, especially when the plan of care 
depends on the involvement of a family caregiver. Suggestions for a 
specific beneficiary survey to use or domains to include in a 
beneficiary survey were provided by several commenters. One commenter 
recommended that, when implementing a beneficiary survey, states find 
ways to be inclusive in assessing care experience to ensure those with 
intellectual disabilities or other cognitive impairment, language, or 
cultural barriers are included, while ensuring that the results remain 
statistically reliable. Another commenter noted concern about the 
potential to use the results from a survey of beneficiary experience to 
impose payment penalties or sanctions on physicians.
    Response: We thank the commenters for their recommendations and 
feedback on the current use of beneficiary surveys. Based on the 
current status of performance measurement for LTSS, we do not believe 
that it is the appropriate time to require a beneficiary survey; 
however, we would like to encourage states to explore with their 
stakeholders how to best utilize surveys (such as the HCBS Experience 
of Care Survey or the Nationwide Adult Medicaid CAHPS survey) to 
improve the delivery of LTSS to beneficiaries and to improve their 
experience of care. We anticipate that beneficiary surveys may be used 
as we move forward with the Medicaid and CHIP managed care quality 
rating system (MMC QRS) under Sec.  438.334.
    Comment: A couple of commenters requested a minor language 
modification related to the use of the term ``treatment plan'' citing 
that this term is often used in a medical context and does not fully 
capture the scope and person-centered nature of LTSS. Commenters 
suggested assessing the provision of LTSS services either in the 
beneficiary's person-centered service plan or in the individual care 
plan that may accompany the treatment plan.
    Response: We thank the commenters for their recommendations. We 
recognize that the term treatment plan is a general medical term which 
in the context of LTSS should include information regarding the 
services that the beneficiary is receiving through LTSS and should be 
inclusive of their person-centered service plan or individual care plan 
as appropriate.
    Comment: One commenter requested further clarification on what

[[Page 27685]]

``assessment of care between care settings'' means as it relates to 
LTSS.
    Response: In the preamble to the proposed rule, we defined this as 
an assessment of the care that individuals receive when transitioning 
to different service settings, such as residential to community (or 
vice versa) or residential to hospital (or vice versa), or hospital to 
nursing home (or vice versa). Among other CMS activities on this topic, 
we are testing new tools to collect and share information on the 
functional status of individuals through the TEFT Demonstration Grant 
Program. CMS is also engaged in the implementation of the IMPACT Act of 
2014, which requires reporting of standardized assessment data in 
Medicare with regard to quality measures, resources use, and other 
measures--using common standards and definitions--to facilitate 
coordinated care and person-centered goals.
    After consideration of the public comments, we are finalizing this 
section with modification. We are removing reference to the MMC QRS 
methodology from Sec.  438.330 (a)(2) and will address the public 
notice and comment process for the MMC QRS methodology in Sec.  438.334 
of the final rule. We have struck proposed Sec.  438.330(a)(2)(i) as 
this is now addressed in paragraphs (c) and (d) of this section. In 
light of this, we have combined proposed Sec.  438.330(a)(2)(ii) with 
Sec.  438.330(a)(2) in the final rule. We have made non-substantive 
revisions throughout Sec.  438.330 to improve clarity. This includes 
adding paragraph (a)(3) to more clearly reflect which components of 
this section apply to PCCM entities described in Sec.  438.310(c)(2) of 
the final rule. Finally, we are correcting a typographical error in 
paragraph (d)(1) so that it correctly references paragraph (a)(2) of 
this section.
(d) State Review and Approval of MCOs, PIHPs, and PAHPs (New Sec.  
438.332)
    Under proposed Sec.  438.332, as a condition of contracting with a 
state to provide Medicaid benefits, MCOs, PIHPs, and PAHPs must undergo 
a performance review. These options were proposed in Sec.  438.332(a) 
and (b). In paragraph (a), we proposed that the state would review and 
approve based on standards that are at least as stringent as those used 
by the accreditation organizations that are recognized by CMS in MA or 
the Marketplace. We proposed that states would review and reissue 
approval of each MCO, PIHP, and PAHP at least once every 3 years. We 
also proposed that MCOs, PIHPs, and PAHPs maintain performance with 
state standards at the level necessary for approval for as long as they 
participate in the state's managed care program.
    Under proposed paragraph (b), a state could rely on accreditation 
by one of the CMS-recognized private accrediting entities to deem one 
or more plans compliant with the review and approval standard proposed 
in paragraph (a). In paragraph (c), we proposed that states make the 
final approval status of each MCO, PIHP, and PAHP, publicly available 
on the state's Medicaid Web site. For additional discussion of proposed 
Sec.  438.332, see section I.B.6.b.1.d of the June 1, 2015 proposed 
rule.
    We received the following comments on proposed Sec.  438.332.
    Comment: Numerous comments were submitted regarding options 
available to states for managed care plan review and approval. Some 
commenters supported adding a state review process, others opposed. 
Most commenters--even those supporting the concept--recommended changes 
to the proposed provision.
    While several commenters supported allowing private accreditation 
received by Marketplace and Medicare plans to satisfy the Medicaid 
review process, many expressed concern that current private 
accreditation processes do not reflect the needs of vulnerable Medicaid 
beneficiaries--for example, children, pregnant women, individuals with 
special health care needs, or those receiving LTSS. A few commenters 
recommended that states only be permitted to accept accreditation 
specifically of the Medicaid managed care business line of an MCO, PIHP 
or PAHP. Other commenters supported state flexibility in determining 
the review and approval process, including use of existing state review 
processes. Several commenters requested that CMS clarify or identify 
the accrediting bodies recognized for MA and Marketplace plans that 
would also apply to Medicaid plans.
    Several commenters expressed concern about the administrative 
burden and potential cost related to accreditation and/or a state 
review and approval process. Several commenters were concerned, in 
particular, that the proposed state review process would be duplicative 
of current EQR processes which are already required; some requested 
clarification on how state review and approval would differ from EQR 
and whether it would replace elements of EQR. Another commenter asked 
if stringent EQRs would satisfy the new state review and approval 
requirement for new plans. Others questioned the federal capacity to 
oversee a robust accreditation or review process for Medicaid plans. 
Some of these commenters were concerned that a review process which 
lacked adequate resources at the state and federal level would 
undermine other measures aimed at improving quality and transparency 
for Medicaid beneficiaries.
    Several commenters also were concerned that state review standards 
should include meaningful public stakeholder input. Several commenters 
noted, in particular, the importance of input from stakeholders 
knowledgeable about managed care long-term services and supports 
(MLTSS), behavioral health, child health care, and specialty plans. 
These commenters believed it critical that the final regulations 
specify measures to ensure robust stakeholder input. Several commenters 
also recommended full transparency of review standards, including 
private accreditation standards deemed by states through the review and 
approval process, and that these be available to the public at no cost 
or for a nominal fee.
    Several commenters requested clarification on the timeline 
available for states to implement the review and approval process. One 
commenter recommended piloting the process first. A few commenters 
recommended a timeframe that allows for state procurement processes to 
be implemented, while several commenters requested the process be 
phased-in to accommodate costs and administrative burden. One commenter 
recommended the state review include a managed care plan readiness 
assessment. Another commenter recommended CMS adopt the approach for 
QHP accreditation (45 CFR 155.1045 and 156.275), which allows states to 
establish the timeline for plans to become accredited.
    Response: We thank the commenters for the many thoughtful and 
specific recommendations regarding the potential impact of this 
requirement. After carefully considering the comments, we agree that 
the information to be obtained through the proposed state review and 
approval process is duplicative of other quality initiatives, such as 
existing EQR-related activities, validated data submitted through T-
MSIS, and the proposed MMC QRS. We also share commenters' concerns that 
private accreditation may not adequately reflect elements of quality of 
care that are key to vulnerable populations disproportionately 
represented in the Medicaid program. The resources required by states 
and CMS to implement this new requirement, including potentially 
requiring some states to develop their own accreditation standards and 
process, seem disproportionate to the

[[Page 27686]]

value that would be yielded. Therefore, to minimize administrative 
burden and enable states and CMS to focus more resources on the EQR and 
QRS processes, we have decided not to finalize the state review and 
approval provisions at proposed Sec.  438.332(a) and (b). Note that 
this decision does not affect existing state authority to require 
accreditation of plans with which they contract. Indeed, CMS continues 
to view the accreditation process as a valuable tool for promoting the 
quality of care, and encourage states to use it as a tool.
    We are retaining the requirement proposed at Sec.  438.332(c), with 
revision, that states post the accreditation status of their Medicaid 
plans. This is consistent with the goals of maximizing the transparency 
of information on a plan's quality of care, and aligning with the 
availability of information for consumers in the Marketplace and 
Medicare. Because not all Medicaid plans may have received private 
accreditation, we are revising Sec.  438.332 in the final rule to 
provide at paragraph (a) that states must confirm the accreditation 
status of the contracting MCOs, PIHPs, and PAHPs at least once per 
year. Under Sec.  438.332(b) of the final rule, states must require 
their contracted managed care plans to authorize the release of the 
most recent accreditation review to the state. Finally, paragraph (c) 
requires that states post and update the accreditation status of their 
managed care plans on their Web sites at least annually.
    While we are not finalizing a requirement to establish a new state 
review process, we agree that input from all stakeholders, including 
those representing individuals needing LTSS, is essential to states' 
quality improvement efforts. The stakeholder engagement process 
required under Sec.  438.70 along with the managed care plan member 
advisory committees (at Sec.  438.110), beneficiary support system 
(Sec.  438.71), quality measurement and reporting (part 438 subpart E), 
grievance and appeal system (part 438 subpart F) and the reporting 
requirements for each of these requirements, all contribute to a 
framework which ensures that stakeholder concerns are identified and 
addressed. In addition, regardless of operating authority (for example, 
section 1915(c) or section 1115(a) of the Act), states generally must 
go through a robust public notice and comment period to launch a new 
managed LTSS program. We are revising Sec.  438.332 to require only 
that states confirm and publically post the accreditation status of 
each contracted MCO, PIHP and PAHP. This information must be updated 
annually on the State's Web site.
    Comment: Several commenters supported availability of state 
approval information on the state's Medicaid Web site. One commenter 
requested that CMS ``explicitly include a requirement in regulatory 
language that information made available on the Web site must include 
whether approval is based on state review or private accreditation, 
level of accreditation, expiration of accreditation, and which approved 
private accreditation entity a plan is accredited by.''
    Response: As noted above, we are retaining the requirement to 
confirm and publicly post accreditation status. Under Sec.  438.332(c) 
of the final rule, states must post the name of the accrediting entity 
as well as the accreditation program and level for each plan, or that 
the plan has not been accredited.
    After consideration of the public comments, we are modifying the 
regulatory text at Sec.  438.332 to: (1) Remove the requirement to 
implement a state review and approval process involving standards at 
least as stringent as the standards used by a private accreditation 
entity recognized by CMS; (2) revise the state review process to 
include review of accreditation status of each MCO, PIHP, and PAHP when 
entering into a contract with the state and on an annual basis 
thereafter; and (3) revise the type of information available on the 
State's Medicaid Web site to include the accreditation status of each 
contracted MCO, PIHP and PAHP and accrediting entity when applicable. 
We are also revising the title of this section to ``State review of the 
accreditation status of MCOs, PIHPs, and PAHPs'' to reflect the content 
of this section in the final rule.
(e) Medicaid Managed Care Quality Rating System (New Sec.  438.334)
    This new section proposed minimum standards that all states 
contracting with MCOs, PIHPs, and PAHPs would use in developing and 
implementing a MMC QRS in order to increase transparency regarding 
Medicaid managed care plan performance, increase consumer and 
stakeholder engagement, and enable beneficiaries to consider quality 
when choosing a managed care plan. For more discussion of the 
development of the MMC QRS proposal, see section I.B.6.b.1.e of the 
proposed rule at 80 FR 31098.
    We proposed in Sec.  438.334(a) that states establish a rating 
system that includes specific factors outlined in the proposed 
regulation. We also proposed that the MMC QRS would utilize the same 
three summary indicators that are currently used to frame the 
Marketplace quality rating system (clinical quality management; member 
experience; and plan efficiency, affordability, and management). We 
proposed that the state's MMC QRS would measure and report on 
performance data collected from each MCO, PIHP, and PAHP on a 
standardized set of measures to be determined by CMS, through a public 
notice and comment process. Further, the measures would be categorized 
within the components proposed in paragraph (a)(2), and states would be 
able to adopt additional measures.
    Under proposed paragraph (b) each state would apply a methodology, 
established by CMS under proposed Sec.  438.330(a)(2), to the 
performance measures described in proposed paragraph Sec.  
438.334(a)(3) to determine the quality rating or ratings for each MCO, 
PIHP, and PAHP serving Medicaid beneficiaries in the state. We proposed 
in paragraph (c) that, subject to CMS approval, states may elect to use 
an alternative or preexisting MMC QRS in place of the MMC QRS developed 
per paragraphs (a) and (b). To avoid duplication of effort, in 
paragraph (d), we proposed providing states with the option to default 
to the MA Five-Star Rating system for those plans that serve only 
beneficiaries enrolled in both Medicare and Medicaid. Finally, in 
paragraph (e), we proposed that states prominently display the quality 
rating given by the state to each MCO, PIHP or PAHP online in a manner 
that complies with the language and format standards of Sec.  
438.10(d).
    We received the following comments on proposed Sec.  438.334.
    Comment: Many commenters supported the creation of a MMC QRS, 
including several commenters that believed aligning the MMC QRS with 
the rating systems used for other coverage types will help individuals 
transitioning to and from other sources of coverage to better 
understand the quality of the plans to which they have access. A few 
commenters believed CMS should follow the Marketplace QRS rather than 
create another rating system that could cause confusion.
    Response: We appreciate the commenters' support for the MMC QRS. We 
are finalizing this requirement with modification, as described below. 
We recognize there is benefit to alignment when appropriate and expect 
to align on the major summary indicators of the Marketplace QRS; 
however, since Medicaid and the Marketplace differ in the population 
groups covered and the services provided, the specific quality measures 
within each summary

[[Page 27687]]

indicator that comprise the MMC QRS may differ from those in the 
Marketplace QRS. For example, Medicaid covers a larger populations of 
children and pregnant women than are enrolled in the Marketplace. As 
such, the MMC QRS summary indicator for clinical care will need to 
include a more robust set of measures to assess care for these 
populations than are included in the Marketplace QRS. Therefore, while 
we are not adopting in whole the Marketplace QRS, the final regulations 
at Sec.  438.334(b) provide that the MMC QRS developed by CMS will 
align with the summary indicators used for of the Marketplace quality 
rating system.
    Comment: Many commenters did not support using the MA Five-Star 
Rating system as an appropriate model for Medicaid managed care plans. 
Commenters believed that the MA Five-Star Rating system does not 
account for the differences in the Medicare and Medicaid populations in 
terms of socioeconomic risk factors, the higher occurrence of 
comorbidities in dual eligible beneficiaries, and the need for LTSS. A 
few also expressed concern that the MA Five-Star Rating system was 
designed primarily to serve adults age 65 and older and persons with 
disabilities; and therefore, would not adequately reflect Medicaid 
managed care plans' success in serving persons with special health care 
needs that are not in the Medicare population. Others requested that 
states opting to use the MA Five-Star Rating system require plans to 
report on LTSS measures as well. One commenter questioned if MCOs 
offering D-SNPs in combination with Medicaid services will be subject 
to both a MA Five-Star Rating and a second MMC QRS rating.
    Response: After careful consideration of the comments and concerns 
received, we are not finalizing the proposed option for states to 
default to the MA Five-Star Rating system for those plans that serve 
dual eligible beneficiaries only. We will coordinate with other CMS 
components operating quality ratings systems in order to develop 
performance measures appropriate for enrollees needing LTSS, children, 
dual eligible beneficiaries, persons with special health care needs, 
and individuals with low socioeconomic status, as well as adjustments 
to the methodologies to account for these populations and measures.
    Comment: Several commenters recommended that FFS programs and other 
emerging delivery systems be subject to the MMC QRS to ensure high-
quality coverage for all Medicaid beneficiaries regardless of delivery 
system and to create comparable data for use by state policymakers. One 
commenter noted a recent study in Missouri that compared the state's 
managed care and FFS programs.
    Response: Performance measurement in the Medicaid FFS setting is in 
an earlier stage of development than exists for managed care. To obtain 
information on quality of care in FFS, CMS currently asks states to 
collect and report data on the CMS Child and Adult Core Measure Sets 
for Medicaid and CHIP for both FFS and managed care. However, we 
believe that application of methodologies developed for quality rating 
systems in managed care to FFS would be premature at this time.
    Comment: One commenter asked that CMS consider LTSS performance 
measures as a separate summary indicator.
    Response: We intend to utilize a robust public engagement process. 
In addition, Sec.  348.334(b) of the final rule provides for a period 
of public notice and opportunity to comment during the development of 
the MMC QRS by CMS. We will consider such comments during that public 
engagement and notice and comment process.
    Comment: Many commenters believed that CMS should allow states to 
adopt alternative MMC QRS to account for the variability of Medicaid 
programs, geographic variation, and medically diverse populations. 
Several commenters wanted minimum core parameters or key content areas 
included, while a few commenters believed CMS should establish a list/
toolkit of existing and ``well respected'' standard performance 
measures, from which states would then be able to select measures that 
most closely align with their needs, and require that all states use 
roughly the same methodology for calculating rating scores to build 
consistency across programs.
    Some commenters recommended that states be required to demonstrate 
a substantial state-specific purpose to utilize an alternative MMC QRS 
contingent upon CMS approval. One commenter believed that CMS should 
consider the following for justification: (1) Holding managed care 
plans more accountable for areas of quality outlined as priorities for 
improvement within a state's comprehensive quality strategy; or (2) 
giving greater weight to certain measures of greater importance to the 
quality of care for a particular population in that state. Some 
commenters also requested that the general public have an opportunity 
to view and provide comment on the states' justifications and requests.
    A few commenters recommended that states be given broad latitude on 
the development, implementation, and timing of the MMC QRS to assure 
that it recognizes local needs and successes. They also recommended 
that CMS partner with states to outline the criteria for approval of 
alternative MMC QRS following promulgation of the final rule. One 
commenter noted that the alternative MMC QRS would give states the 
ability to leverage quality improvement by adopting developmental and 
innovative measures that are unlikely to appear in a national core 
measure set.
    Response: We believe that the regulations requiring CMS approval of 
an alternative MMC QRS should retain sufficient flexibility to enable 
states to tailor an alternative system which meets the unique needs of 
the state, including the potential use of developmental measures, and 
are finalizing Sec.  438.334(c) with revision. We will allow states to 
adopt an alternative MMC QRS upon approval by CMS, provided that the 
ratings generated by the alternative MMC QRS yield substantially 
comparable information regarding MCO, PIHP, and PAHP performance to 
that yielded by the CMS-developed MMC QRS. Changes to approved 
alternative MMC QRS will also require CMS approval.
    Comment: A few commenters believe that in order to ensure a fair 
and accurate evaluation of quality, it is essential that performance 
measures are weighted consistently across the program. They asked that 
states not be given the option to modify the standard weights or 
definitions assigned to a measure to ensure a fair and accurate 
evaluation of quality because alternate systems could be less robust 
than federal standards, to the detriment of consumers. They believed 
that ``fixed weights'' would provide a transparent, unbiased view 
across State managed care programs. Several commenters also expressed 
concern that allowing alternate MMC QRS programs without federal 
prioritization and consolidation of quality measures will add 
administrative waste in the healthcare system.
    Response: We interpret the commenters' terminology of ``fixed 
weights'' as a standard calculation methodology utilized for all states 
in order to allow consistent comparison of plans across states. We 
appreciate the commenters' concerns about the use of consistent weights 
or an alternative MMC QRS methodology. The methodology for the MMC QRS 
will be defined in consultation with experts and with a public 
engagement process

[[Page 27688]]

and a public comment period. However, we believe it is important to 
provide states with an option to tailor the MMC QRS, including measures 
and methodology, to the quality assessment needs of the state. We note 
that states cannot utilize an alternative MMC QRS under Sec.  
438.334(c) of the final rule without prior CMS approval and note that 
any alternative MMC QRS must yield information regarding MCO, PIHP, and 
PAHP performance which is substantially comparable to that yielded by 
the MMC QRS developed by CMS. Generally, this means that the measures 
and methodology a state chooses should result in a QRS that utilizes 
comparable information to that which will be included in the finalized 
CMS-developed QRS. We expect to issue final guidance on alternative QRS 
and comparability following the public notice and stakeholder 
engagement process.
    Comment: A few commenters requested that CMS delay implementation 
of the MMC QRS until more guidance is given. Other commenters were in 
support of the proposed 3-5 year timeline for implementation.
    Response: States will not be required to implement a MMC QRS until 
3 years after CMS issues guidance specifying the measures and 
methodologies for the MMC QRS, which in turn first requires 
consultation with states and other stakeholders and a public notice in 
the Federal Register with opportunity to comment. We anticipate 
releasing guidance specifying the measures and methodologies for the 
MMC QRS in 2018, which would result in states implementing a MMC QRS in 
2021 (within 3 years after issuance of the guidance). To formalize this 
timeframe, the regulations at Sec.  438.334(a)(3) provides that states 
must implement such MMC QRS within 3 years of a final notice published 
in the Federal Register. This timeframe is designed to provide 
sufficient time for CMS to develop and for states to implement a robust 
MMC QRS.
    Comment: One commenter believes there are limitations to utilizing 
a national model or national data in states where there may be few data 
points for percentile distributions. Additionally, the commenter noted 
that national data does not allow consumers to compare their state 
level options meaningfully.
    Response: We are not proposing that states define their percentile 
distributions based on aggregated data across states. Rather each 
state's MMC QRS will use state level data that will provide comparisons 
across plans within a state.
    Comment: One commenter requested that CMS consider the impact of 
the MMC QRS in areas where only one managed care plan is available. The 
commenter believed that in the instance where there is not choice of a 
managed care plan, a MMC QRS could deter Medicaid enrollment. Another 
commenter requested that CMS not require a MMC QRS in a state where 
only one managed care plan operates.
    Response: We believe that a MMC QRS has benefits beyond managed 
care plan choice. Public reporting of quality ratings in regions with 
only one plan allows for informed consumers and stakeholders and thus, 
robust public awareness and discussion about managed care plan 
performance. It also can provide incentive for the managed care plan to 
improve the quality of care or for the state to consider securing a 
contract with a different managed care plan.
    Comment: A few commenters asked CMS to gather data from states to 
evaluate the robustness of a MMC QRS within a reasonable time after 
implementation.
    Response: We will periodically review the CMS-developed MMC QRS to 
determine the need for modification and to ensure continuing alignment 
with the Marketplace QRS. CMS will evaluate the robustness of each 
alternative MMC QRS prior to approving it for use to ensure that it 
yields information regarding MCO, PIHP and PAHP performance which is 
substantially comparable to the information yielded by the CMS 
developed MMC QRS. We will consider additional possibilities for 
evaluation during the MMC QRS post implementation period, however, it 
is premature to develop such a plan at this time.
    Comment: A few commenters recommended that CMS seek input through 
robust stakeholder engagement using a consensus-building approach that 
involves the public, managed care plans, state officials, advocacy 
groups and other stakeholders, and that decisions about the measure 
selection and rating systems should be made in a transparent and open 
process with an opportunity for public comment. A few commenters 
requested that CMS use a public comment process similar to the 
requirements for section 1115(a) demonstration projects. Several 
commenters requested that the public comment process be explained in 
detail in the final rule.
    Several also requested that CMS only approve an alternative system 
after states include evidence of consultation with stakeholders. Other 
stakeholders asked that CMS develop a rollout strategy to ensure 
vetting of measures and alternative MMC QRS programs are comparable 
across states.
    Response: We appreciate the need for an open public comment 
process. We will utilize a process similar to that used by CMS in the 
development of the Marketplace QRS, which included multiple stakeholder 
listening sessions. We also will publish the proposed methodology and 
quality measures framework in a Federal Register notice that will 
include opportunity for public comments. Information about the 
Marketplace QRS can be found at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Health-Insurance-Marketplace-Quality-Initiatives.html.
    We will also require that states requesting to adopt an alternative 
MMC QRS, or to modify an approved alternative MMC QRS, provide an 
opportunity for public comment of at least 30-days and obtain the input 
of the state's Medicaid Medical Care Advisory Committee established 
under Sec.  431.12. Under Sec.  438.334(c) of the final rule, CMS 
expects that requests for alternative MMC QRS will document the public 
comment process utilized by the State including discussion of the 
issues raised by the Medical Care Advisory Committee and the public. 
The request must also document any policy revisions or modifications 
made in response to the comments and rationale for comments not 
accepted.
    Comment: One commenter recommended CMS adopt the Marketplace 
standard for posting of QRS results and that CMS decline to post the 
results of the MMC QRS while they are being tested and validated.
    Response: We will consider this request as we move forward with MMC 
QRS development and look forward to additional input regarding public 
display during the public engagement process.
    Comment: A few commenters requested that CMS address the needs and 
vulnerabilities of Medicaid beneficiaries by identifying and 
acknowledging impacts of social determinants of health, such as lower 
health literacy, socioeconomic risk factors, and higher occurrence of 
comorbidities in the Medicaid population, on the quality ratings 
achieved by managed care plans. The commenters suggested we develop a 
risk stratification based on populations served, building on the work 
of the NQF and Measure Applications Partnership on core measure sets 
for adult and child

[[Page 27689]]

beneficiaries and risk adjustment for socio-demographic factors.
    Response: We will consider such comments during the public 
engagement and notice and comment process that will be utilized for the 
development of the MMC QRS, which we anticipate will reflect risk 
stratification and other methodological adjustments for socioeconomic 
risk factors and other social determinants of health. We also note that 
CMS recently announced a new demonstration model, Accountable Health 
Communities, to develop approaches to the issues raised.
    Comment: Several commenters offered suggestions for CMS to consider 
when choosing measures for the MMC QRS, including managed care plan 
performance related to access to care; managed care plan 
administration, claims processing and appeals processing; cultural 
competency and accommodation of people with disabilities at the 
provider and managed care plan level; and transportation. Commenters 
also suggested creating separate summary indicators, ratings, or 
separate reporting programs for certain subpopulations such as 
children, including children with complex medical needs, pregnant 
women, individuals needing behavioral health services and individuals 
needing LTSS. Several commenters recommended that a rating system 
should address all populations being served, as well as the care 
provided within the managed care plan.
    Response: We will consider such input on quality reporting measures 
and requirements as part of the public engagement and public notice and 
comment process. The approach to measurement may differ depending on 
whether certain services that may apply to specific subpopulations are 
included in a MCO or if they are provided in a PIHP or PAHP (for 
example, one which provides only dental or behavioral health services). 
We anticipate releasing guidance in 2018 following the public 
engagement and notice and comment process.
    We note that in states with PIHPs or PAHPs for behavioral health or 
other specialty services, the comprehensive managed care plans and the 
PIHPs and PAHPs are subject to both the MMC QRS and the requirements 
for the QAPI Program (Sec.  438.330). States, comprehensive plans and 
behavioral health PAHPs can draw from the behavioral quality measures 
in the Child and Adult Core Sets for Medicaid and CHIP for their QAPI 
program.
    Comment: One commenter requested timely and comprehensive revision 
of managed care plan contracts to reflect the financial burden 
associated with a MMC QRS.
    Response: We interpret this comment as a request that the 
development of capitation rates take into account the administrative 
costs for managed care plans associated with the MMC QRS. As discussed 
in section V.C.22 of the preamble, we do not expect the MMC QRS to pose 
an additional burden for managed care plans; instead, we expect states 
will rely on information already provided by the managed care plans to 
develop the quality ratings (for example, performance measures required 
for QAPI per Sec.  438.330(c)). Given this, we do not anticipate that 
the MMC QRS would necessitate a change in capitation rates.
    Comment: One commenter requested that the data already being 
reported by managed care plans, including claims and administrative 
data, be leveraged where possible to reduce burden. A few commenters 
asked CMS to consider data collection; system capabilities; format; and 
content of MMC QRS reports; and to utilize education and outreach.
    Response: We agree that available data should be utilized when 
possible to reduce burden. We will consider data collection, systems, 
reports, refinement, education, and evaluation as we develop the final 
guidance for the MMC QRS and would expect to take into consideration 
similar concerns in reviewing a state's request for approval of an 
alternative MMC QRS. We look forward to additional input through the 
future public engagement process.
    Comment: A few commenters noted that only one dental measure is 
currently being considered for the Marketplace QRS and encouraged CMS 
not only to set a standard for quality rating for dental services that 
can be extended to MCOs and dental PAHPs in the future, but also to 
emphasize oral health preventive services covered by Medicaid's EPSDT 
benefit package for children. One commenter suggested that CMS allow 
states to continue implementation of dental-specific quality 
improvement programs until such time as appropriate accreditation, 
quality ratings systems and dental-specific survey tools are developed 
with dental industry stakeholders. The commenter stated that states do 
not generally extend accreditation or QRS standards to managed dental 
contracts or services contractors that administer these programs.
    Response: We appreciate the commenters' concerns about quality 
measurement and improvement efforts related to dental services. Through 
the public engagement and MMC QRS development process, we will seek 
input from HHS partners, stakeholders and other experts, on the 
specific measures that should be considered for dental services. The 
approach to measurement and improvement may differ depending on whether 
dental services are included in a comprehensive managed care plan or if 
they are provided in a dental-specific managed care plan (such as a 
dental PAHP). We anticipate releasing guidance in 2018 following the 
public engagement and notice and comment process.
    We fully support the continuation of dental-specific quality 
improvement projects and have developed guidance for managed care 
dental PIPs. Section Sec.  438.334 does not impact the PIPs required 
under Sec.  438.330(d) and therefore has no bearing on the ability of a 
state or managed care plan to conduct a PIP relating to oral health.
    Comment: A few commenters encouraged CMS to use and continuously 
test simple, straightforward language to display MMC QRS ratings for 
consumers. Commenters noted that Medicaid enrollees have varied levels 
of education and literacy and that it is important for language, 
definitions, and scoring of the MMC QRS to be easily understood.
    Response: We appreciate the need to employ plain language and to 
ensure accessibility for LEP individuals both in the development of a 
MMC QRS as well as in displaying the data after collection. Section 
Sec.  438.334(e) of the final rule requires states to prominently 
display the quality rating given to each managed care plan on the state 
Web site in a manner that complies with the standards in Sec.  
438.10(d), which requires taking into consideration the special needs 
of enrollees or potential enrollees with disabilities or limited 
English proficiency. We look forward to additional public engagement 
regarding beneficiary communication during the public notice and 
comment process required under Sec.  438.334(b) of the final rule.
    Comment: One commenter agreed that it is important that measures 
reflect current priorities and practices; however, they believed that 
updating measures every 2 to 3 years is too frequent, because system 
development and implementation of new or additional measures is 
resource intensive and does not allow adequate time to measure trends 
in managed care plan performance or results of improvement efforts. The 
commenter stated that continual changes to measures also limit the 
comprehensive development, implementation, and

[[Page 27690]]

effectiveness of interventions. Another commenter asked that CMS 
consider a 2 to 3 year measure development/change process to avoid 
retrospective changes in weighting star thresholds.
    Response: We did not propose, and are not finalizing, a specified 
timeframe for updating performance measures, but will consider these 
comments as a part of the public engagement and notice and comment 
process we will use to develop final guidance.
    Comment: One commenter asked CMS to ensure that all quality metrics 
have been tested and have performance expectations appropriate for 
managed care plans. Additionally the commenter asked that all quality 
metrics, incentives, or withholding of payments should reflect value-
based purchasing concepts. The commenter recommended such methodologies 
be provided to the managed care plan prior to the effective period of 
the contract. Another commenter suggested that CMS replace the 
development of a MMC QRS with a measure of the degree of provider 
engagement in value-based purchasing. One commenter requested that CMS 
ensure that the MMC QRS not duplicate current quality incentive 
programs already in place at state or federal levels.
    Response: We did not propose any value-based purchasing programs, 
quality incentives, or withholds of payments related to the MMC QRS.
    Comment: One commenter requested that CMS align measures and 
reporting cycles with already existing programs when available. Other 
commenters suggested CMS align with the HEDIS[supreg] measurement 
cycle.
    Response: We agree with aligning with existing programs/measurement 
cycles when possible. We are finalizing our proposal to align the MMC 
QRS components with those used in the Marketplace QRS. We will continue 
to consider opportunities for alignment and burden reduction in the 
development of the MMC QRS.
    Comment: A few commenters supported a phased in option so that all 
three summary indicators do not have to be initially considered but 
would be phased in by the end of a set period of time. This approach is 
proposed to ensure that stakeholders are given adequate lead time to 
fully understand the measure specifications, data collection 
methodology and reporting strategy.
    Response: As discussed above, states will not be required to 
implement a MMC QRS until 3 years after CMS issues guidance specifying 
the measures and methodologies for the MMC QRS, which in turn first 
requires consultation with states and other stakeholders through a 
public notice in the Federal Register and opportunity to comment. This 
timeframe is designed to provide sufficient time for CMS to develop and 
for states to implement a robust MMC QRS.
    Comment: While most commenters supported alignment with the summary 
indicators utilized by the Marketplace QRS, several commenters 
suggested that CMS replace the term ``affordability'' with 
``efficiency'' because affordability may be viewed as meaning a ``lower 
capitated rate or lower out of pocket expenses.'' Other commenters 
simply believed the term affordability would be confusing.
    Response: We appreciate the commenters support for alignment with 
the Marketplace QRS summary indicators. In order to maintain ongoing 
alignment with any future revisions to the Marketplace QRS summary 
indicators, in the final rule we are replacing the names of the current 
Marketplace QRS summary indicators (clinical quality management, member 
experience, and plan efficiency, affordability, and management) with a 
cross-reference to the Marketplace QRS regulation at 45 CFR 156.1120. 
This will allow the MMC QRS to adapt to changes in the Marketplace QRS 
and allow for ongoing alignment. We understand commenters' concerns 
regarding the potential for confusion around the term affordability, 
however, we have eliminated reference to this term in the regulation 
text.
    Comment: A few commenters believed that while a MMC QRS can 
encourage transparency and even strengthen the oversight process, a 
poorly designed or executed MMC QRS could result in beneficiaries with 
inaccurate or untimely information.
    Response: We agree with the commenters and look forward to 
additional input from stakeholders throughout the public engagement and 
notice and comment process.
    Comment: One commenter emphasized the importance of member surveys 
accounting for the significant cultural and language diversity among 
Medicaid beneficiaries as well as the number of children and 
underserved populations enrolled in Medicaid.
    Response: We agree that the diversity of the populations served by 
Medicaid can present challenges in conducting member experience 
surveys. CMS, through the multi-stakeholder engagement process for the 
development of the MMC QRS, will solicit feedback on survey methods 
that are effective in reaching the diverse populations served by 
Medicaid.
    Comment: One commenter asked CMS to publish results more than once 
annually allowing for a more 'real time' availability of information.
    Response: CMS will consider such comments during the stakeholder 
engagement and public notice and comment process that will be utilized 
for the development of the MMC QRS.
    Comment: One commenter asked if CMS intends to provide enhanced FFP 
for MMC QRS-related activities since the development and implementation 
of the MMC QRS is expected to require significant administrative 
resources from states.
    Response: Under Sec.  438.358(c)(6) of the final rule, assistance 
with the quality rating of MCOs, PIHPs, and PAHPs is an optional EQR-
related activity. As such, consistent with Sec.  438.370(a) of the 
final rule, expenditures for an EQRO's assistance with the quality 
rating required under Sec.  438.334 with respect to a MCO are eligible 
for the 75 percent match rate. Consistent with Sec.  438.370(b), 
expenses associated with quality rating of a PIHP or PAHP are eligible 
for the regular administrative match rate (50 percent), regardless of 
whether the activities are performed by the state, an EQRO, or another 
contractor or state agent.
    After consideration of the public comments, we are finalizing with 
modification our proposal that states contracting with MCOs, PIHPs, and 
PAHPs develop and implement a MMC QRS. Section 438.334(a) requires 
states contracting with MCOs, PIHPs, or PAHPs to adopt either the MMC 
QRS developed by CMS or an alternative MMC QRS, and implement such MMC 
QRS within three years of the date of a final notice published in the 
Federal Register. Section 438.334(b) has been redesignated as paragraph 
(d) and revised to describe the collection of data from each MCO, PIHP 
and PAHP to issue a quality rating and to specify that the state must 
issue a quality rating annually for each contracted MCO, PIHP, and 
PAHP. New paragraph (b) provides for CMS to develop a MMC QRS, through 
public notice and comment that aligns with the summary indicators of 
the Marketplace QRS developed per 45 CFR 156.1120. Section 438.334(c) 
has been revised to affirm that states may adopt an alternative MMC 
QRS, contingent upon CMS approval, that utilizes different performance 
measures and/or applies a different methodology from that described in 
paragraph (b), provided that the ratings generated by the alternative 
MMC QRS yield information regarding MCO, PIHP, and PAHP performance 
which is substantially

[[Page 27691]]

comparable to that yielded by the MMC QRS. We have also modified 
paragraph (c) to include requirements for a state public engagement 
process prior to submitting a proposal for, or modification to, an 
alternative MMC QRS and requirements for applications to CMS for 
approval of alternative MMC QRS. We have removed proposed paragraph 
(d), which would provide an option for states to elect to rely on the 
MA Five-Star Rating for MCOs, PIHPs, and PAHPs serving exclusively dual 
eligible beneficiaries.
(f) Comprehensive State Quality Strategy (New Sec. Sec.  431.500, 
431.502, 431.504, 431.506, and 438.340)
    Under the existing regulations at Sec.  438.202(a), states 
contracting with MCOs or PIHPs have been required to maintain a written 
strategy for assessing and improving the quality of services offered by 
all MCOs and PIHPs. We proposed adding a new subpart I to part 431 that 
would require a comprehensive quality strategy (CQS) that applied to 
services provided through all delivery systems, including a FFS 
delivery system, not just those provided through an MCO or PIHP. We 
also proposed additional CQS elements which would apply to states that 
contract with an MCO, PIHP, PAHP, or PCCM entity (described in proposed 
Sec.  438.3(r)) to deliver Medicaid services.
(1) Basis and Scope (New Sec.  431.500)
    We proposed that each state be required to have a comprehensive 
quality strategy to address and support efforts to strengthen quality 
in a state's Medicaid managed care program (inclusive of MLTSS 
programs, where applicable), as well as other types of delivery systems 
for Medicaid services. In proposed Sec.  431.500(a) we described the 
statutory basis of the proposed new subpart I, including the authority 
to adopt standards for a quality strategy established in section 
1932(c) of the Act for MCOs, and in section 1902(a)(4) of the Act for 
PIHPs. We relied as well on section 1902(a)(4) of the Act because 
development of a comprehensive quality strategy for all service 
delivery systems would promote efficient and proper administration of 
the state plan. We also proposed to rely on section 1902(a)(6) of the 
Act, for purposes of the proposed reporting requirement; section 
1902(a)(19) of the Act; and section 1902(a)(22) of the Act.
    In paragraph (b), we proposed that the scope of this new section 
establish parameters for states to develop a comprehensive quality 
strategy to monitor the delivery of quality health care to Medicaid 
beneficiaries. This would include states contracting with MCOs, PIHPs, 
or PAHPs, those utilizing a PCCM arrangement, and those that deliver 
services through FFS. We solicited comments on our proposal for a 
comprehensive quality strategy.
    We received the following comments on proposed Sec.  431.500.
    Comment: One commenter noted that, as recognized by CMS in its 
revised interpretation of the EQR matching rate, provisions in section 
1932(c) of the Act regarding quality are specific to MCOs with a 
contract subject to the requirements in section 1903(m) of the Act. In 
light of this, the commenter requested that the comprehensive quality 
strategy be made optional and that the state retain the discretion in 
determining elements of the comprehensive quality strategy including 
the ability to have the strategy apply to its managed care program 
only.
    Response: We disagree with the commenter's view that the fact that 
section 1932(c) of the Act applies only to MCOs means quality 
requirements cannot be imposed on other managed care entities, such as 
PIHPs and PAHPs, or for other delivery systems. As noted above, section 
1902(a)(4) of the Act allows for such methods of administration as are 
found by the Secretary to be necessary for the proper and efficient 
operation of the Medicaid State plan. Based upon this authority, the 
current regulations already apply quality provisions set forth in in 
section 1932(c) of the Act to PIHPs. We believe that this authority 
also authorizes the Secretary to require states to draft and implement 
a comprehensive quality strategy addressing all Medicaid delivery 
systems utilized in the state. However, as discussed in section 
I.B.6.b(2)(f)(2) of the preamble below, we are not finalizing the 
proposed provisions in part 431, subpart I. We are finalizing the 
extension of the managed care quality strategy to states contract with 
PAHPs and PCCM entities (as described in Sec.  438.310(c)(2) of this 
final rule); see discussion in section I.B.6.b(2)(f)(5) of the preamble 
below.
(2) State Comprehensive Quality Strategy (New Sec.  431.502)
    The current regulations at Sec.  438.202(a) identify 
responsibilities for the managed care quality strategy for states 
contracting with MCOs and PIHPs. Proposed Sec.  431.502(a) set forth a 
general rule requiring a comprehensive quality strategy in all states 
addressing all Medicaid delivery systems.
    In paragraph (b)(1), we proposed that the strategy include the 
state's goals and objectives for continuous quality improvement, which 
would be required to be measurable and take into consideration the 
health status of all Medicaid-covered populations in the state. Under 
the proposal states would be required to take into account a variety of 
data (such as population health status, service utilization and 
expenditure information, quality of life issues, quality metrics, etc.) 
when developing such goals. In paragraph (b)(2), we proposed that 
states be required to identify the specific quality metrics and 
performance targets that they plan to use to measure performance and 
improvement, which would be linked to the goals identified in paragraph 
(b)(1). Further, we proposed that states be required annually to 
publish these quality metrics and performance standards on their Web 
site.
    We received the following comments on proposed Sec.  431.502.
    Comment: Many commenters expressed support for the proposed 
comprehensive quality strategy requirements, specifically the extension 
of the comprehensive quality strategy requirements beyond managed care 
to include Medicaid FFS, which they believed would help to: (1) Improve 
the health of the broader Medicaid population by encompassing all 
Medicaid services regardless of delivery system; (2) advance state 
efforts to measure and improve the quality of care provided to children 
and adults in Medicaid; (3) improve monitoring and oversight of FFS 
delivery systems, which one commenter noted still serves more than a 
quarter of Medicaid beneficiaries, including those who are often the 
most vulnerable beneficiaries with significant health care needs; (4) 
promote transparency and quality of care; and (5) avoid the risk of 
creating standards that vary by delivery system. One commenter believed 
that a CQS would support comparisons of quality of care across 
different delivery models. Another commenter supported measuring 
quality of care in an effort to achieve optimal outcomes and publicly 
reporting performance results in an understandable way. Another 
believed that the evaluation of a CQS would supply invaluable data in 
states that are newly transitioning to managed care as well as in 
states that are moving more populations into managed care.
    A few commenters expressed support for the proposed CQS but were 
concerned that requiring every state to develop a strategy, including 
its own quality standards, and its own list of measures would add a 
potentially heavy burden for states, increase the number of measures 
and disparate activities, and diminish the likelihood that quality

[[Page 27692]]

efforts would result in improved outcomes. Several commenters noted 
that while flexibility would let states design their activities to meet 
their own needs, it would also mean that there would be little, or no, 
alignment between states. A few commenters recommended that having a 
single common set of topics and related measures from which to choose 
would lead to a more unified approach to measurement and greater 
opportunities for collaborative improvement work. One commenter 
expressed concern that, if state-established goals and objectives are 
not strictly aligned with CMS and/or NCQA accreditation standards, the 
result could be duplicative or misaligned requirements. While 
understanding of the need for state flexibility, this commenter 
recommended CMS establish parameters to avoid this outcome.
    Other commenters did not support the proposed comprehensive quality 
strategy. Some of these commenters pointed to the challenges of 
incorporating a small or shrinking FFS population into a comprehensive 
quality strategy. One commenter noted that the populations served by 
FFS often are small and disparate, which would make it difficult for a 
state to develop an effective strategy. Others noted that the 
populations in FFS may be eligible for a limited set of benefits (such 
as family planning services) or may be eligible for a limited period of 
time (for example, medically needy beneficiaries eligible only during 
part of a budget period after meeting a spenddown amount in accordance 
with Sec.  435.831, or individuals prior to initial enrollment in a 
managed care plan). Some commenters pointed out that many performance 
measures and performance improvement programs may not apply to FFS 
beneficiaries, or may prove impractical to collect based on the limited 
sample size or the poor fit between the measure and the population. One 
commenter sought guidance on how a state should incorporate goals and 
objectives relating to a shrinking FFS population.
    One commenter recommended allowing states with more than 80 percent 
of their Medicaid beneficiaries in managed care to be exempted from any 
requirement to develop a comprehensive quality strategy, while another 
recommended that states be provided an option to include FFS delivery 
systems in their quality strategy, but not be required to do so. This 
commenter noted that a voluntary approach would allow each state to 
direct limited resources to quality activities which the state 
determines will have the most impact and which are best suited to meet 
future program growth. Another commenter believed that the inclusion of 
a very small population of FFS beneficiaries would detract from a 
state's ability to focus on measuring the quality of care provided to 
enrollees in managed care.
    A few commenters noted that states, which currently do not 
generally have in place performance measurement or improvement 
activities for the FFS population, would have to invest additional 
resources to meet the comprehensive quality strategy requirement. One 
of these commenters believed that this change would push states to 
reconsider the use of FFS. Another believed that to include the FFS 
population in the comprehensive quality strategy, states essentially 
would have to develop an organizational structure and staff similar to 
that of an accredited MCO. While one commenter believed that its state 
could include FFS in the overall quality strategy with existing staff 
and resources (other than implementing a consumer survey and 
performance improvement plan), several commenters believed that states 
would need time and resources to build a solid structure to achieve 
quality measurement and improvement in FFS. These commenters 
recommended that CMS provide support to states in building the 
requisite capacity, including an enhanced match for all quality 
activities and sufficient lead time to prepare for the development and 
implementation of a comprehensive quality strategy. Another commenter 
noted that a comprehensive quality strategy will require extensive 
review and updating by CMS, which may be difficult to maintain.
    One commenter expressed general opposition to the proposed 
comprehensive quality strategy, noting that the variety of changes 
proposed, including the expansion to additional managed care programs, 
additional elements to be included in the CQS, and the requirement to 
update the plan every 3 years instead of every 5 years, would require 
significantly more work than what is presently required.
    Two commenters requested clarification regarding the application of 
the comprehensive quality strategy to FFS beneficiaries and certain 
small populations (such as dual eligibles).
    Response: We appreciate the commenters' thorough consideration of 
this proposal. While most commenters believe that a comprehensive 
quality strategy could offer valuable information about, and promote 
improvements in, the quality of care provided by state Medicaid 
programs, specifically regarding the beneficiaries served by FFS, we 
recognize that the proposed requirement could pose significant 
logistical and resource challenges for states, many of which may lack 
the infrastructure and expertise necessary to develop and implement a 
quality strategy that addresses quality of care for beneficiaries in 
FFS, which is different from the strategies appropriate for managed 
care. We also appreciate that shrinking FFS populations and FFS 
populations that receive a limited benefit package pose challenges to 
the development and implementation of a comprehensive quality strategy 
addressing all delivery system models.
    After considering the entirety of the comments regarding the 
proposed comprehensive quality strategy, we are convinced that the time 
and resources required to develop and implement a comprehensive quality 
strategy would be higher than we estimated in the proposed rule, and 
could hamper other state quality efforts. Therefore, we are withdrawing 
proposed subpart I of part 431 in its entirety. We will, however, 
retain the requirement for a managed care quality strategy, described 
in Sec.  438.340 of the final rule (see discussion in section 
I.B.6.b(2)(f)(5) below). We are retaining the requirement in Sec.  
438.340 of the final rule that states contracting with MCOs, PIHPs, and 
PAHPs, as defined in Sec.  438.2, or with a PCCM entity described in 
Sec.  438.310(c)(2) of the final rule (describing PCCM entities with 
shared savings or other financial incentives tied to improved quality 
outcomes)--will be required to draft and implement a quality strategy 
consistent with Sec.  438.340. Since we are retaining the requirement 
for a managed care quality strategy applicable to multiple managed care 
contractual arrangements in Sec.  438.340, we are revising Sec.  
438.310 in the final rule to reflect the basis and scope for this 
broader applicability of the Medicaid managed care quality strategy.
    We strongly encourage states to report on the CMS Child and Adult 
Core Measure Sets for Medicaid and CHIP, and to explore other ways to 
measure, improve, and report on the quality of care in FFS. States 
interested in expanding the scope of their quality improvement efforts 
to FFS beneficiaries may wish to consult our November 22, 2013 SHO 
letter, Quality Considerations for Medicaid and CHIP Programs (SHO #13-
007, available at http://www.medicaid.gov/Federal-Policy-Guidance/downloads/SHO-13-007.pdf) as well as the preamble to the proposed rule 
(80 CFR 31098).

[[Page 27693]]

    Comment: One commenter noted that CMS requires development of a 
quality strategy in section 1915(b) and 1915(c) waivers, and in all 
section 1115(a) demonstrations. This commenter agreed that states 
should have quality strategies in place, but advocated for 
consolidation of the separate and independent quality-related 
requirements that relate to the different federal program authorities. 
The commenter believed that although a comprehensive quality strategy 
has the potential for added efficiency, CMS's history of expanding the 
scope of state reporting on quality measures has not been accompanied 
by an effort to consolidate and streamline requirements across the 
various federal authorities.
    Response: We appreciate the commenter's concern about the 
interaction of the various quality requirements required by different 
Medicaid statutory authorities. The quality strategies required under 
other authorities (including sections 1915(c) and 1115(a) of the Act) 
are outside the scope of this rulemaking. Managed care authorized under 
section 1915(b) waivers are subject to the requirements of part 438, 
including the quality strategy requirements, unless explicitly waived. 
As also discussed, we are withdrawing the proposed requirement for a 
mandatory comprehensive quality strategy covering FFS delivery systems.
    Comment: One commenter recommended that CMS also develop a national 
comprehensive quality strategy that states could default to in the 
absence of their own or if their strategy had not been updated in more 
than 3 years.
    Response: We have developed and updated a robust Quality Strategy, 
which is aligned with the HHS National Quality Strategy, and we 
encourage states to align their quality strategies with ours and the 
HHS National Quality Strategy (as appropriate). We do not believe it 
would be appropriate for states to have the option to default to a 
national quality strategy, given that section 1932(c)(1) of the Act 
explicitly requires states to develop and implement their own quality 
strategy for Medicaid MCOs contracting with the state. Therefore, we 
reject the commenter's recommendation.
    Comment: Two commenters recommended that the elements of a 
comprehensive quality strategy incorporate the three aims of the 
National Quality Strategy, including the specific recommendation that 
the list of minimum requirements for the comprehensive quality strategy 
would include at least four of the six priorities and four or more of 
the nine levers of the National Quality Strategy.
    Response: We appreciate the commenters' support for the National 
Quality Strategy. While we are withdrawing the proposed comprehensive 
quality strategy, we encourage states to consider how their quality 
programs can align with the National and CMS Quality Strategies, and 
how the concepts in these strategies can support state activities and 
initiatives. While we are continuing the requirement for a Medicaid 
managed care quality strategy in Sec.  438.340, we decline the 
commenters' recommendation to require states' specifically include 
components of the National and CMS Quality Strategies. The national 
documents are designed to address a broad array of public health and 
coverage programs; state Medicaid managed care quality strategies are 
much more specific documents which must focus on each state's unique 
managed care program(s), populations, and benefits. We do not believe 
it would be appropriate to place a requirement as described by the 
commenters on states given the unique and specific nature of a state 
Medicaid managed care quality strategy.
    Comment: One commenter stated that there should be transition of 
care standards for all Medicaid beneficiaries transitioning between 
Medicaid delivery systems, and that this should be included in the 
quality strategy.
    Response: Section 438.62(b)(3) as proposed would require that 
states describe their transition of care policy in their comprehensive 
quality strategies. While we are withdrawing the proposal for a 
comprehensive quality strategy in part 431, subpart I to include FFS 
delivery systems, we are adding a cross reference to Sec.  438.62(b)(3) 
in Sec.  438.340 of the final rule to retain the requirement to include 
a transition of care policy in the managed care quality strategy under 
the final rule.
    Comment: A number of commenters recommended additional elements for 
comprehensive quality strategies, such as: (1) Identification and 
reduction of preventable events, including adverse drug events; (2) 
drug utilization review; (3) advanced care planning; (4) examination of 
payment rates and health care worker wages as they relate to quality 
and access; (5) for LTSS, consideration of the need for workforce 
training and incentives to have a career in health care and LTSS (for 
example, wages and benefits, and conditions of work); (6) adoption of 
the principles set forth in the finalized HCBS regulation for MLTSS; 
(7) person-centered planning and service delivery, including person-
centered goals and activities; (8) pediatric quality improvement; and 
(9) consideration of all populations served by Medicaid when reviewing 
network adequacy and availability of service standards.
    Response: We thank the commenters for their recommended additions 
to the elements of a proposed comprehensive quality strategy. As we are 
withdrawing our proposal for a comprehensive quality strategy, but 
retaining the requirement for a managed care quality strategy in Sec.  
438.340, we will respond to these suggestions in that context. Many of 
the recommended additions are addressed elsewhere in this rule or in 
other existing Medicaid regulations, including: Sec.  438.3(g) 
(relating to provider-preventable conditions); Sec.  438.3(s) (relating 
to drug utilization review); Sec. Sec.  438.3(o), 438.70, 438.71, 
438.208, 438.214, and 438.816 (relating to MLTSS and person-centered 
planning); and proposed Sec.  438.358(b)(3) and (b)(4) (relating to 
validation of network adequacy and availability of services). While we 
agree that the workforce plays an important role in the availability 
and quality of services, we do not believe that workforce-related 
assessments and efforts represent an appropriate mandatory element for 
each state's quality strategy. Regarding children's health, by 
requiring that the state consider the health status of all populations 
served by its managed care plans, the quality strategy necessarily 
encompasses pediatric quality improvement. Finally, we note that while 
Sec.  438.340 establishes the minimum standards for a quality strategy, 
states may include additional items at their discretion. Stakeholders 
also can use the state's public engagement process to recommend 
additional, state-specific elements for the quality strategy.
    Comment: A number of commenters expressed support for the 
requirement that a comprehensive quality strategy's goals and 
objectives be measurable, noting that some states' current goals and 
objectives lack metrics to demonstrate measurable results. Several of 
these commenters noted the benefit of measurable goals and objectives 
specifically for FFS as a way to help improve monitoring and oversight.
    Response: We appreciate the commenters' support. We believe that it 
is important for states to be able to measure and assess their progress 
towards defined quality goals in an objective manner. While we are 
withdrawing the proposed comprehensive quality strategy, which would 
have addressed services

[[Page 27694]]

delivered FFS, we continue to encourage state efforts to measure and 
improve quality of care for services furnished by FFS providers.
    Comment: Regarding the reference in proposed Sec.  431.502(b)(1) to 
``all populations,'' a number of commenters suggested that CMS 
explicitly identify key populations served by Medicaid, including: (1) 
People with disabilities and older adults; (2) children, with 
particular attention to those with special health care needs; (3) 
pregnant women; and (4) relevant population segments from the ``Bridges 
to Health'' model \11\ article. Commenters believed that specifying 
broad population segments would help to ensure that no major population 
segment is overlooked in comprehensive quality strategies. A few also 
noted that quality measurement and performance improvement strategies 
differ for children and adults, for pregnant women compared to the 
general adult population, and for healthy children compared to children 
with special health care needs.
---------------------------------------------------------------------------

    \11\ Bell, KM., Jencks, SF., Kambric, RT., Lynn, J., & Straube 
BM. (2007, June). Using population segmentation to provide better 
health care for all: the ``Bridges to Health'' model. The Milbank 
Quarterly. Retrieved 21 July 2015, from http://www.ncbi.nlm.nih.gov/pubmed/17517112.
---------------------------------------------------------------------------

    Response: As noted, we are withdrawing the proposal for a 
comprehensive quality strategy that includes FFS delivery systems. 
While we share the commenters' belief that all populations enrolled in 
managed care must be considered in a state's quality strategy, we do 
not believe it would be appropriate to highlight certain populations or 
population segments in the regulations and not others, particularly 
given that the populations enrolled in managed care vary from state to 
state. Section 438.340 of the final rule incorporates the requirement 
that a state's goals and objectives for its managed care program must 
consider the health status of all populations served by the state's 
managed care plans. The language is intentionally flexible to 
accommodate differences between the managed care populations in 
different states. We agree that performance measurement and improvement 
approaches may differ by population, and encourage states to take these 
differences into consideration when developing or revising a quality 
strategy.
    Comment: A number of commenters recommended that CMS ensure that 
``health status'' is understood broadly to include: Mental health, with 
a specific focus placed on what mental health comprises; functional 
status; quality of life in the community; and an individual's well-
being. One commenter noted that if we are to improve health, reduce 
disparities, and curb costs, we must look more broadly at health and 
well-being. Another noted that historically, mental health has not been 
treated as part of overall health due to stigma, and noted that it is 
important for CMS to do all it can to ensure the outdated paradigms of 
treating mental health separately from overall health is changed. 
Several commenters recommended CMS modify proposed Sec.  438.340(b)(2) 
to read, ``The State's goals and objectives for continuous quality 
improvement, which must be measurable and take into consideration the 
health status and quality of life of all populations served by the 
Medicaid program.''
    Response: We thank the commenters for this opportunity to clarify 
the meaning of health status. We believe that health status includes 
physical health, behavioral health (which we broadly define to include 
mental health and substance use disorders (SUDs), including use of 
tobacco, alcohol, and other drugs), and functional status. We note that 
while a state must take into consideration the health status of all 
populations served by its managed care plans when developing its goals 
and objectives, the goals and objectives identified in states' quality 
strategies are not required to address all facets of health status. For 
example, a state may identify several different needs based on the 
health status of its populations, but then elect to set goals for only 
some of those needs. States will need to describe the rationale for 
their choices in the quality strategy.
    Comment: A few commenters recommended that comprehensive quality 
strategy efforts should specifically include a pediatric quality 
strategy that is appropriate for all sub-populations of children, 
including children with medical complexity. They, along with other 
commenters, stated that CMS should require states to specifically 
consider pediatric quality improvement in any comprehensive quality 
strategy and use a range of pediatric measures that capture the needs 
of all subpopulations of children, including children with medical 
complexity. Some commenters recommended that performance measurement 
address all subpopulations of children, including children with special 
health care needs. Another commenter noted that children's health care 
presents distinctive challenges for quality measurement, and that any 
effort to measure quality of care should take into account the unique 
features of pediatric health care and recognize the importance of 
pediatric development, dependency, demographics, and disparities. One 
commenter stated that this rulemaking presents an opportunity for CMS 
to focus on health child development and the needs of children with 
special health care needs.
    Response: We appreciate the commenters' support for the delivery of 
quality care to children, including those with special health care 
needs. Managed care plays an important role in the delivery of services 
to children. As noted above, we do not believe it is appropriate to 
identify specific populations in the regulations for inclusion in 
states' quality strategies. Rather, the language in Sec.  438.340 is 
broad, and requires that states' quality strategies take into 
consideration the health status of all populations served by managed 
care, including children. Should we elect to identify a common set of 
national QAPI performance measures or PIPs, under the authority of 
Sec.  438.330(a)(2), we will consider ones that focus on children. 
Therefore, we decline to require the quality strategy include 
additional child-specific components, or to require states to create a 
child-specific quality strategy.
    Comment: A number of commenters recommended either performance 
measurement topics or specific performance measures for inclusion in 
comprehensive quality strategies, including: (1) Timeliness of access 
to providers both within and outside of a plan's network; (2) person-
centered planning and service goals; (3) rebalancing and Olmstead 
planning goals and objectives; (4) workforce issues; (5) 
subpopulations' access to care in other delivery systems, and elements 
that take into account the needs of especially vulnerable patient 
populations; (6) alignment of metrics with Medicare ACO programs, 
specifically the Medicare Shared Savings Program (Shared Savings 
Program) and Pioneer ACO program, where applicable; (7) HIV-specific 
quality and outcome measures; (8) a combination of process and outcome 
measures; (9) children's quality measures; (10) pregnant women exposed 
to intimate partner violence; and (11) metrics related to quality of 
life.
    Response: We appreciate the commenters' recommendations for 
performance measurement topics and specific performance measures. 
Should we elect to identify a common set of national QAPI performance 
measures or PIPs, we will use the notice and comment period described 
in Sec.  438.330(a)(2); performance measure identified through this 
process will be

[[Page 27695]]

incorporated into a state's quality strategy per Sec.  438.340(b)(3). 
We will consider these recommendations during that process, and 
encourage commenters to participate in potential future subregulatory 
guidance processes.
    Comment: Several commenters supported the requirement that states 
publish a selection of quality metrics and performance outcomes at 
least annually on the state's Medicaid Web site, but recommended that 
the regulation be strengthened by also requiring: (1) Public reporting 
of comparative quality information on state Web sites in a user-
friendly format and following established practices for health 
literacy; (2) quality standards and measurements on states' Web sites; 
and (3) states to publish all quality metrics and performance outcomes 
at least annually. These commenters also recommended that CMS should: 
(1) Provide clearer guidance to states to ensure consistent and timely 
availability of performance measurement data, which is necessary to 
promote broad discussion among state policy makers, advocates, and 
consumers; and (2) encourage states to publish quality ``scorecards'' 
that report both statewide and MCO-specific performance results on 
various quality measures.
    Response: We thank the commenters for their support and 
recommendations. There are several places in the proposed rule where we 
addressed the public availability of data on quality of care: (1) The 
quality strategy will include the state's quality metrics and 
performance targets for its managed care plans (proposed Sec.  
438.340(b)(1), finalized at Sec.  438.340(b)(3)(i)); (2) the annual EQR 
technical reports (proposed and finalized at Sec.  438.364) will 
include information from the mandatory EQR-related activity of network 
adequacy validation (finalized at Sec.  438.358(b)(1)(iv)); and (3) 
while not identical to a quality scorecard, states will be required to 
operate a MMC QRS for their managed care plans (Sec.  438.334).
    We encourage states to report comparative quality information in a 
user-friendly format and in accordance with health literacy practices 
required by the state or identified in the state's quality strategy.
    Through our work on the CMS Child and Adult Core Measure Sets for 
Medicaid and CHIP, we actively engage with and provide guidance to 
states to support the collection, analysis, and reporting of these 
performance measures. While we may issue additional guidance in the 
future, we believe that the guidance provided through such direct 
technical support to individual states is the most useful approach.
    Finally, while we encourage states to report on all of the 
performance measures identified in their quality strategies on an 
annual basis, we understand that this may not be feasible and thus 
provide states with the flexibility to identify which measures and 
outcomes they will report on annually. We note that states will report 
publicly on all the measures and outcomes in the quality strategy at 
least once every 3 years in accordance with the evaluation of the 
effectiveness of the quality strategy (proposed Sec.  431.504(b)(1), 
finalized at Sec.  438.340(c)(2)(i) and (ii)).
    Comment: One commenter recommended that CMS require plans to 
achieve minimum performance levels in all CMS Child and Adult Core 
Measure Sets for Medicaid and CHIP to advance the quality and value of 
programs.
    Response: We disagree with the commenter's recommendation. While we 
have an important oversight responsibility for Medicaid managed care 
plans, we do not believe it would be appropriate to establish national 
minimum performance levels. Performance is influenced by many factors, 
including population demographic characteristics and availability of 
health care providers; a national minimum would not account for state 
variation in these and other factors. It is the states that have a 
direct relationship with the managed care plans, and it is the 
contracts between the state and managed care plans that provide states 
with leverage to set minimum performance levels and to incentivize 
managed care plan performance, as many already do.
    Comment: A few commenters suggested ways to improve the CMS Child 
Core Set measures. They recommended that CMS replace less impactful 
measures with validated measures coming out of the Pediatric Quality 
Measures Program and other sources relevant to the populations served, 
and that CMS ensure there is a pathway for much needed pediatric 
quality of care and outcomes measures.
    Response: We appreciate commenters' support for the CMS Child Core 
Set measures. The development and maintenance of the CMS Child Core Set 
measures is outside the scope of this regulation. We encourage 
interested parties to learn more about the Measure Applications 
Partnerships (MAP), a multi-stakeholder partnership HHS uses to 
identify measures for federal health programs, managed by the NQF. 
Additional information on the MAP can be found online at http://www.qualityforum.org/setting_priorities/partnership/measure_applications_partnership.aspx.
    Comment: A number of commenters encouraged us to use this rule-
making as an opportunity to achieve greater integration and use of the 
CMS Child Core Set and the lessons learned from the Pediatric Quality 
Measures Program. Commenters also recommended that CMS require that 
states either include the CMS Child and Adult Core Measure Sets for 
Medicaid and CHIP, including the clinical and the non-clinical 
measures, in their quality improvement programs or use them as a basis 
for selecting metrics. Several commenters recommended that CMS move 
away from voluntary reporting to require a minimum subset of the CMS 
Child and Adult Core Measure Sets for Medicaid and CHIP.
    Response: We appreciate the support from commenters for the CMS 
Child and Adult Core Measure Sets for Medicaid and CHIP. We believe 
that the use of the measure sets over the last few years has been 
beneficial for both CMS and for states. We do not have the authority to 
mandate the use of the CMS Child and Adult Core Measure Sets for 
Medicaid and CHIP. However, we do strongly encourage states to use 
these measure sets as a starting point for their own measure selection 
process. We do not believe it would be appropriate to limit states to 
selecting measures only from the CMS Child and Adult Core Measure Sets 
for Medicaid and CHIP, as there are other nationally validated or 
endorsed measures which may be appropriate for a state's quality 
efforts. We anticipate that, should we elect to identify national 
performance measures under the authority in Sec.  438.330(a)(2), these 
would include measures from the CMS Child and Adult Core Measure Sets 
for Medicaid and CHIP. We will continue to work with states to improve 
collection and reporting of the CMS Child and Adult Core Measure Sets 
for Medicaid and CHIP.
    Comment: One commenter recommended that CMS require states to 
collect and analyze some measures from the CMS Child and Adult Core 
Measure Sets for Medicaid and CHIP annually, while allowing other 
measures to be collected and analyzed on a less frequent basis.
    Response: Adjusting the reporting timeframe for the CMS Child and 
Adult Core Measure Sets for Medicaid and CHIP is outside the scope of 
this rule. We also note that, unless required as a national QAPI 
measure under Sec.  438.330(a)(2), state reporting on the CMS Child and 
Adult Core Measure Sets for Medicaid and CHIP remains

[[Page 27696]]

voluntary. As such, while we encourage states to report on all CMS 
Child Core Set and CMS Adult Core Set measures annually, states have 
the discretion to report on one or more of the measures on a less than 
annual basis.
    Comment: A few commenters noted that, while it is important and 
useful to receive public input on which topics should be pursued in 
large scale improvement activities and which measures should be used to 
track improvement, hospitals and other health care organizations 
already respond to a vast disparate array of mandates and requests for 
data and participation in quality improvement activities. The result is 
a resource intensive effort that leads to confusion and undermines the 
production of robust information on actual performance improvements. 
Several commenters recommended that CMS direct Medicaid programs to 
adopt the set of improvement areas identified in the Institute of 
Medicine's Vital Signs report. The commenters recommended that having a 
single common set of topics and related measures from which to choose 
will lead to a more unified approach to measurement and greater 
opportunities for collaborative improvement work.
    One commenter stated that the process for states to include 
additional quality measures is not clear. The commenter submitted that 
physicians are already overburdened with multiple quality reporting 
systems that use different measures and methodologies. The commenter 
recommended that CMS ensure standardization and harmonization of 
quality measures and methodologies across reporting programs to reduce 
administrative burdens and simplify compliance.
    Response: We appreciate the effort hospitals, providers, and other 
health care organizations make to measure and improve the quality of 
care. We support efforts to align quality measurement and improvement 
efforts, as we strive to publicly report on the CMS Child and Adult 
Core Measure Sets for Medicaid and CHIP, which are identified annually 
based on recommendations of the multi-stakeholder NQF MAP. We encourage 
hospitals, other providers and health care organizations, consumer 
groups, and other stakeholders to comment on the managed care quality 
strategy proposed in their states to ensure that the strategy developed 
reflects the variety of perspectives of parties affected by the 
Medicaid program and promotes harmonization of quality measures and 
methodologies across reporting programs. As noted above, we believe it 
is important that states have flexibility to identify the performance 
measures and improvement topics most appropriate for their Medicaid 
programs. Therefore, we will retain the state flexibility afforded 
under the final rule for states in developing their managed care 
quality strategy at Sec.  438.340.
    Comment: One commenter stated that state reporting on a 
standardized set of metrics and performance outcomes to both CMS and 
the public would facilitate the transition to value-based purchasing, 
and enable accurate comparisons of quality performance across plans. 
The commenter noted the importance of ensuring alignment between the 
standards to which both states and their contracted managed care plans 
are held.
    Response: We appreciate the commenter's support for the use of 
standardized measures and value-based purchasing. We agree that this 
would support performance comparisons across plans. We believe that, in 
regards to the Medicaid managed care requirements, this rule does align 
to the extent possible the standards to which states and plans are 
subject.
    Comment: One commenter recommended that instead of allowing states 
to develop their own metrics for a comprehensive quality strategy, 
states should be required to rely on the metrics used in the MMC QRS to 
be established by CMS per Sec.  438.334(b).
    Response: While we support alignment between quality efforts, we 
decline the commenter's recommendation, as states need flexibility to 
select metrics appropriate to the goals, objectives, and initiatives it 
has identified for its Medicaid managed care program. Further, while 
both the MMC QRS under Sec.  438.334 and the managed care quality 
strategy under Sec.  438.340 require performance measurement, they have 
a different purpose, and thus different performance measures may be 
appropriate.
    Comment: A number of commenters recommended that CMS require that 
states' quality strategies include a plan to assess, address, and 
reduce health disparities in the state. They stated that addressing 
health disparities should be a top priority in quality measurement and 
improvement and recommended that quality measures be reported 
stratified by such demographic factors as age; race; ethnicity; sex; 
primary language; population; region or geography; MCO or other managed 
care plan provider; disability status; or other risk factors to the 
extent possible to identify populations that continue to be at risk of 
adverse outcomes. Some commenters suggested that states also should 
collect and evaluate data stratified by sexual orientation, gender 
identity, and health status. Two commenters recommended that states 
track quality data and outcomes on persons with mental illness and 
substance use disorders that cycle through the criminal justice system, 
state psychiatric hospitals, and Medicaid. Another commenter 
recommended that reducing disparities in access should address both 
health services and LTSS.
    Commenters recommended that stratifying quality data by the key 
factors called for in the Affordable Care Act would sharpen quality 
improvement interventions, identify groups that continue to be left 
behind, and provide critical information on whether managed care is 
helping to resolve the longstanding inequities in our health care 
system. They noted that HHS has produced reports with recommendations 
on how to improve data collection for health disparities in Medicaid 
and CHIP, and that support from the Adult Medicaid Quality Grants 
Program helped states build their capacity to collect and report data 
stratified by key demographic categories. One commenter recommended 
that states include the metrics developed by the Agency for Healthcare 
Research and Quality (AHRQ) for its Quality and Disparities Report, or 
another established institution, to track health disparities.
    One commenter cited section 1311(g) of the Affordable Care Act, 
which requires insurers to have an incentive program to, among other 
things, reduce health and health care disparities, and noted that 
requiring the comprehensive quality strategy to address disparities 
would assure that consumers in the Medicaid program who might be victim 
of such disparities receive no less attention than their counterparts 
in the Marketplaces. Other commenters noted that the Affordable Care 
Act requires any federally conducted or supported health care or public 
health program, activity or survey to collect and report data 
stratified by race, ethnicity, sex, primary language, geography, and 
disability status to the extent practicable. Commenters noted that 
while HHS has moved to implement this mandate for national Medicaid 
population health surveys and to incorporate it into Medicaid claims 
data based updates, states have just begun to address the issue of 
health disparities in quality measurement in Medicaid managed care.
    Some commenters recommended inclusion of additional language in 
Sec.  438.340 to ensure that the state's

[[Page 27697]]

quality strategy include a ``plan to identify, evaluate and reduce 
health disparities through its quality improvement strategy, including 
efforts to expand the collection and reporting of performance data 
stratified by race, ethnicity, sex, primary language, geography and 
disability status and actions taken to reduce health care 
disparities.''
    Response: We agree that it is important for states, and their 
managed care plans, to work to reduce health disparities for their 
beneficiaries and are adding an element to the quality strategy 
required under Sec.  438.340 to require that states' quality strategies 
address health disparities based on race, ethnicity, sex, primary 
language, and disability status, consistent with the factors identified 
in section 3101(a)(1)(A) and (B) of the Public Health Services Act, as 
amended by section 4302 of the Affordable Care Act, as recommended by 
commenters, as well as by age, which we believe is important given the 
populations served by Medicaid. We understand that states may face 
significant challenges in collecting data and analyzing disparities 
based on these factors, and therefore decline to include the other 
factors recommended by commenters, which are beyond our legal authority 
to require states to collect and analyze. We note that in the proposed 
rule we inadvertently omitted a requirement at former Sec.  
438.204(b)(2) that states provide certain specified demographic 
information to managed care plans about their Medicaid enrollees at the 
time of enrollment. We are retaining this provision in Sec.  
438.340(b)(6) of the final rule.
    In response to these comments, we are: (1) Retaining the 
requirements in proposed Sec.  431.502(a) at Sec.  438.340(a) of the 
final rule, with modification to specify that it applies to all 
Medicaid services provided by the MCO, PIHP, PAHP, or PCCM entity 
(described in Sec.  438.310(c)(2)); (2) retaining the requirements from 
proposed Sec.  431.502(b) within Sec.  438.340(b) of the final rule, 
with non-substantive revisions for clarity; (3) adding a new element at 
Sec.  438.340(b)(3)(i) of the final rule to describe quality metrics 
and performance targets used to measure performance; (4) adding a 
reference to the description of a state's transition of care policy 
consistent with Sec.  438.62(b)(3) at Sec.  438.340(b)(5); and (5) 
adding an element focused on identifying, evaluating, and reducing 
health disparities based on age, race, ethnicity, sex, primary 
language, and disability status, to the extent practicable, as Sec.  
438.340(b)(6). We also are retaining at Sec.  438.340(b)(6) a 
requirement formerly at Sec.  438.204(b)(2) requiring states provide 
specified demographic information to MCOs, PIHPs, and PAHPs for each 
Medicaid enrollee at the time of enrollment. See section 
I.B.6.b(2)(f)(5) for additional discussion of Sec.  438.340 of the 
final rule. (3) Comprehensive quality strategy development, evaluation, 
and revision (new Sec.  431.504)
    In Sec.  431.504, we proposed to extend the current regulations at 
Sec.  438.202(b), (d) and (e) (relating to states' responsibility to 
obtain public input into the state quality strategy, to evaluate the 
effectiveness of the strategy, and to submit the strategy to CMS for 
review) to the comprehensive quality strategy which would have been 
required under the proposed rule, as opposed to applying specifically 
to the quality strategy required for states contracting with managed 
care plans. We also proposed modest revision of the current regulation 
as follows.
    We proposed at Sec.  431.504(a) to add the State Medical Care 
Advisory Committee and tribes (through tribal consultation), as 
appropriate, to the existing list of persons and entities from which 
the state would obtain input when developing the quality strategy, and 
that this input be obtained prior to submitting the comprehensive 
quality strategy to CMS, to ensure that stakeholder concerns have been 
taken into consideration at an early phase in the quality strategy 
development process.
    In paragraph (b), we proposed to revise the existing requirement in 
Sec.  438.202(d) that states review and update their strategy ``as 
needed'' but with a requirement to do so at least once every 3 years. 
We encouraged states to view the comprehensive quality strategy as a 
living document, which should be updated on a regular basis to account 
for changes in population, delivery systems, emerging information 
system technology, and benefit design. We also proposed to improve 
clarity by using ``review and update'' instead of ``conduct reviews . . 
. and update'' in the regulation text.
    We proposed moving the evaluation of the effectiveness of the 
quality strategy into a new paragraph (b)(1) and, in paragraph (b)(2), 
we proposed that states make the results and findings of this 
effectiveness evaluation publicly available on the state's Medicaid Web 
site. The language from the current Sec.  438.202(e)(2) relating to the 
submission of regular reports on the implementation and effectiveness 
of the strategy also was included in proposed Sec.  431.504(b)(1) and 
(b)(2). We proposed that states post these on their Medicaid Web site, 
rather than submitting such reports to CMS as required under the 
current regulation.
    In paragraph (c)(1), we proposed revision of the existing language 
in Sec.  438.202(e)(1) that the state submit a copy of its initial 
strategy to CMS to clarify that submission is for the purposes of 
receiving CMS comment and feedback before adopting the comprehensive 
quality strategy in final. In paragraph (c)(2), we proposed that states 
submit a copy of the revised strategy whenever significant changes are 
made. We also proposed that states include their definition of 
``significant changes'' within the body of the quality strategy. 
Finally, in paragraph (d), we proposed that states make their final 
comprehensive quality strategy available on the state's Medicaid Web 
site.
    We received the following comments in response to proposed Sec.  
431.504.
    Comment: Many commenters offered general support for the 
comprehensive quality strategy processes proposed under Sec.  431.504. 
One commenter expressed support for allowing states flexibility to 
provide updates to the quality strategy when there are major 
programmatic changes (that is, changes affect a significant portion of 
the covered population or major changes in payment methodology), and to 
require that they do so at least once every 3 years.
    Response: We appreciate commenters' support for the proposed 
comprehensive quality strategy development, evaluation, and revision 
standards. While we are withdrawing the proposal for a comprehensive 
quality strategy, we are retaining this proposed provision for states' 
managed care quality strategies in Sec.  438.340, with minor 
modification (see section I.B.6.b(2)(f)(5) for additional discussion of 
Sec.  438.340 of the final rule).
    Comment: A number of commenters expressed general support for CMS' 
efforts to integrate MCAC and tribes into the quality strategy process, 
and recommended the identification of additional specific organizations 
or stakeholder groups, including: Dental Quality Alliance (DQA), as a 
part of the development of any quality strategy that includes the 
delivery of dental services in Medicaid; health care workers; managed 
care plans; the LTSS community; key disability advocacy organizations; 
physicians; individuals in nursing facilities waiting for community 
transitions; and local multi-payer, multi-stakeholder Regional Health 
Improvement Collaboratives (RHICs). One commenter recommended that CMS 
direct states to create

[[Page 27698]]

mechanisms to facilitate more robust and ongoing engagement with direct 
care workers who provide Medicaid-funded services to help set and 
achieve state quality goals, especially in the area of LTSS.
    Response: We appreciate the commenters' interest in ensuring that 
states obtain input from a variety of interested parties in the 
development of a quality strategy but are declining the specific 
suggestions. The proposed rule would have required states to obtain the 
input of the MCAC, beneficiaries, and other stakeholders as 
appropriate. As noted, we are not finalizing our proposal to require 
development of a comprehensive quality strategy in all states to 
address all delivery systems, including FFS, and we believe the 
proposed language is appropriately flexible and necessary to reflect 
the broad range of stakeholders that may need to be included in the 
public consultation process, depending upon the populations served in 
the state's Medicaid managed care program, the benefits offered by the 
plans, and the quality initiatives in the state. The current language 
is broad enough to include the various entities identified by the 
commenters, but does not require that states include specific 
organizations or interests, which may or may not be appropriate in a 
given state, as long as the full range of interests and perspectives is 
represented. We are retaining the public engagement requirement from 
proposed Sec.  431.504(a) in Sec.  438.340(c)(1), with clarification 
that states must consult with tribes, in accordance with the state's 
tribal consultation policy, if the state enrolls Indians in its MCOs, 
PIHPs, or PAHPs.
    Comment: Many commenters recommended that CMS provide further 
details about the public engagement process, including whether states 
must or are encouraged to: (1) Provide adequate notice of a public 
comment period, including prominently on the state Web site; (2) 
conduct well-publicized public hearings to educate stakeholders on the 
details of the proposed comprehensive quality strategy and give them 
the opportunity to provide direct feedback; (3) post a detailed and 
comprehensive draft comprehensive quality strategy for comment for at 
least 30 days; (4) accept public comments via in multiple modalities, 
including electronically, by phone and through the mail; and (5) submit 
to CMS a detailed response to stakeholder comments collected, including 
reasons for altering or not altering the draft in response to those 
comments.
    Other recommendations for additional guidance include requiring 
states: (1) To conduct statewide meetings of stakeholders that include 
representation from the breadth of affected individuals (for example, 
individuals with disabilities, LTSS consumers and their family 
caregivers, people with limited English proficiency, and 
representatives from the LGBT community); (2) to make their quality 
strategy available on the state Medicaid Web site for public comment 
and review; (3) to establish and publicize a Web site that facilitates 
public comment on and recommendations for the quality strategy; (4) to 
adopt the National Council on Disability's guidance to states on 
stakeholder involvement. One commenter recommended that CMS set a 
minimum comment period of 60 days for comprehensive quality strategy 
creation and revisions.
    Finally, many commenters recommended that the comprehensive quality 
strategy undergo a public comment process that meets the same 
requirements as the public notice and comment process for the section 
1115(a) demonstration projects.
    Response: While we appreciate the commenters' interest in 
clarification of the process states should use to solicit input from 
MCAC, beneficiaries, and other stakeholders, we believe it best to 
leave this process to state discretion, particularly in light of our 
decision not to finalize a requirement that states develop a proposed 
comprehensive quality strategy addressing delivery systems other than 
managed care and states' historic experience soliciting public input 
into managed care quality strategies. We expect states to utilize their 
Medicaid Web site, as well as any other state standard practices, when 
soliciting public comment on their Medicaid managed care quality 
strategy. We do not believe that the extensive public notice process 
utilized for section 1115 demonstrations is appropriate for developing 
or updating quality strategies, which must be fully compliant with 
federal law and regulations, while section 1115(a) demonstrations 
involve the use of waivers and/or expenditure authorities to operate a 
state's Medicaid program in a manner that deviates from what is 
normally allowable under statute in order to test innovation.
    Comment: One commenter expressed concern regarding the amount of 
time required to coordinate with a state's waiver programs, managed 
care plans, advisory committees, and CMS for effective feedback and 
implementation.
    Response: We appreciate the commenter's interest in ensuring 
sufficient time is allowed for effective feedback and implementation. 
We understand that this effort will involve time and resources from a 
state, which is part of why we are establishing a 3-year lifecycle for 
state quality strategies. The proposed language differs very little 
from the language in the existing regulations, issued in 2003, adding 
only MCAC and tribal consultation in accordance with the State's Tribal 
consultation policy, as appropriate, to the existing public input 
process, and requiring additional public input before revising an 
existing quality strategy. We do not believe that this process will 
pose a significant additional burden on states.
    Comment: Two commenters recommended that the review and update of 
the quality strategy should include data on waitlists, including the 
numbers of individuals that received services in home and community 
settings of choice and numbers of individuals that moved into a more 
restrictive setting while waiting for their choice of home and 
community setting, numbers of people locating the housing they wanted, 
numbers of people that learned about the community they want to live 
in, numbers that learned to use public transit, the effectiveness and 
impacts of waiting list strategies and policies, and other items 
related to person-centered planning and the services utilized while 
individuals were on waiting lists.
    Response: This final rule does not alter quality strategy or 
monitoring requirements for Medicaid home and community based services 
waivers and state plan amendments. Sections 1915(c), (i), and (k) have 
unique quality assurance and oversight processes. Given this, we 
decline to accept this recommendation, but encourage states to consider 
if any of the data identified by commenters would be useful to the 
states' programs. We agree that it is important for states to monitor 
and assess the delivery of LTSS; at Sec.  438.340(b)(9) we are 
finalizing a cross-reference to Sec.  438.208(c)(1) of this part, which 
requires states to implement mechanisms to identify persons in need of 
LTSS or with special health care needs.
    Comment: A few commenters recommended that states review and update 
their comprehensive quality strategies more frequently (either annually 
or no less often than once every 2 years) rather than once every 3 
years. One commenter urged that each state's quality strategy be 
reviewed, updated, opened for input and comment annually, because in 
the commenter's view a 3 year cycle is too long.

[[Page 27699]]

    Response: We appreciate the recommendation from the commenters. We 
are sensitive to the balance between maintaining an up-to-date quality 
strategy and the investment necessary to develop and implement a 
strategy. It is also important to allow sufficient time to determine if 
the strategy had the desired effect. We believe that a 3-year life 
cycle for a quality strategy strikes the appropriate balance. We note 
that states may elect to revise their quality strategy more frequently.
    Comment: One commenter recommended that CMS permit states to align 
the timing for updates to their quality strategy with changes in the 
National Quality Strategy and the CMS Quality Strategy. The commenter 
recommended that CMS identify opportunities to do this, and if 
necessary, provide flexibility around the 3-year update requirement.
    Response: We appreciate the commenter's support for alignment 
between state comprehensive quality strategies and the National and CMS 
Quality Strategies. While we encourage states to align their managed 
care quality strategies with the National and CMS Quality Strategies, 
alignment may not always be the most appropriate approach to support 
state-targeted quality efforts, and therefore alignment is not required 
under the final rule. States do have flexibility to update their 
strategies more frequently than the once every 3 years specified under 
the rule, which would allow states to pursue alignment with national 
quality strategy efforts, including CMS quality efforts.
    Comment: A few commenters recommended CMS must approve a state's 
quality strategy before it can be adopted as final.
    Response: Proposed Sec.  431.504(c) and (d), which are now 
redesignated to Sec.  438.340(c)(3) and (d) of the final rule, require 
states to submit an initial quality strategy to CMS for comment and 
feedback prior to finalizing the strategy, and to make the final 
quality strategy available on the state's Web site required under Sec.  
438.10(c)(3). We do not believe it is feasible for us to review and 
approve all aspects of every state's strategy prior to implementation. 
However, state quality strategies must conform to the regulations, and 
are subject to oversight and implementation of corrective measures if 
they are not compliant. We will provide technical assistance to a state 
when a managed care quality strategy does not fulfill a regulatory 
requirement, so that the state can come into compliance.
    Comment: Another commenter requested that CMS ensure it has 
sufficient resources to conduct an adequate and thorough review of 
state quality strategies. The commenter believed that appropriate 
review of these strategies by CMS is important for achieving long-term 
quality goals of the Medicaid and CHIP programs.
    Response: We appreciate the commenter's support for the important 
role of CMS review in quality improvement and oversight activities for 
Medicaid and CHIP. We believe that any concerns about the adequacy of 
our capacity to provide meaningful comment and review of states' 
quality strategies should be alleviated by the withdrawal of the 
proposed comprehensive quality strategy and the finalization of only 
the managed care quality strategy requirements. We believe that we have 
sufficient capacity to review states' managed care quality strategies, 
as we currently do under existing regulations.
    Comment: A few commenters stated that CMS should require states to 
post their comprehensive quality strategy on the state Medicaid Web 
site no later than 10 days after submission to CMS.
    Response: We thank the commenters for this recommendation; however, 
we are not adopting it. The version of the quality strategy submitted 
to us by a state to CMS represents an interim document. While we 
encourage states to post this version of the quality strategy to their 
Web sites, as a means of updating the public on the status of the 
development of the quality strategy, we do not believe it would be 
appropriate for us to require the state to post it. We do require 
states to post the final quality strategy online.
    Comment: A commenter requested clarification regarding the nature 
of the evaluation of the effectiveness of the quality strategy. The 
commenter asked whether it is intended to be a formal evaluation plan 
that quantifies the progress and outcomes of programs described in the 
quality strategy, or a reevaluation of the effectiveness of the 
programs prior to revision of the quality strategy. The commenter also 
requested clarification of the structure of the required report and the 
need for an external evaluator.
    Response: We appreciate the commenter's interest in the quality 
strategy evaluation. Under current regulations, states are required to 
submit regular reports on the implementation and effectiveness of their 
quality strategy. Historically, this has not always occurred on a 
consistent or regular basis, or in a transparent manner. The final rule 
provides for a standalone report focusing on the progress states have 
made in reaching goals and objectives identified in their quality 
strategy. This would include an analysis of how the identified 
performance measures and PIPs contributed, or did not contribute, to 
the state's progress. We defer to states to determine whether the 
analysis required is best conducted by an internal or external 
evaluator.
    Comment: One commenter recommended CMS clarify the meaning of 
``update'' in proposed Sec.  431.504(b). The commenter recommended that 
CMS clarify whether the term refers to adjusting to different quality 
initiatives or modifying current quality initiatives.
    Response: We appreciate this opportunity to clarify this 
requirement, finalized at Sec.  438.340(c)(2). At least once every 3 
years, a state must examine their quality strategy, evaluate the 
effectiveness of that strategy, and use that information, combined with 
feedback from the state's EQRO per Sec.  438.364(a)(4), to update its 
quality strategy to better drive improvement over the next 3 years. In 
some cases, this may mean identifying new goals and objectives or new 
quality initiatives to supplement or replace existing initiatives, 
while in other cases a state may make small adjustments to ongoing 
efforts. As the exact nature of the update will be dependent on the 
unique circumstances in a state and the findings of its quality 
strategy evaluation efforts, we decline to modify the regulatory text 
to more specifically define ``update.'' However, we are adding Sec.  
438.340(c)(2)(iii) to clarify that the update should take into 
consideration any recommendations offered by the state's contract EQRO 
under Sec.  438.364(a)(4).
    Comment: Several commenters recommended that CMS further define 
``significant changes'' which would trigger a revision of the quality 
strategy. Another commenter recommended CMS clarify whether or not 
adjusting state targets for performance measures on an annual basis 
would be considered a significant change or not.
    Response: We appreciate the need to understand what would 
constitute a ``significant change.'' Consistent with the language in 
the proposed rule, we believe this is best determined by the state; 
however, in recognition of the importance of this definition and 
consistent with our proposal, we are finalizing our proposal to require 
the state to include its definition for a ``significant change'' in the 
quality strategy (see Sec.  438.340(b)(11) of the final rule).
    Comment: One commenter stated that updates to the comprehensive 
quality strategy should not automatically trigger an evaluation of the 
document's

[[Page 27700]]

effectiveness or stakeholder consultation, as would be the case under 
proposed Sec.  431.504(b). To ensure that states can treat their 
strategy as a ``living document,'' the commenter recommended CMS 
clarify that not all updates will trigger a review of the strategy's 
effectiveness or the extensive stakeholder consultation envisioned 
under the proposed rule.
    Response: We agree with the commenter that not all changes would 
trigger an evaluation of the effectiveness of the quality strategy or 
the solicitation of public input. The effectiveness evaluation must 
occur once every 3 years; it is not triggered solely by a revision to 
the quality strategy. The solicitation of public input is triggered by 
the once every 3 year update and by revisions due to significant 
changes as defined in a state's quality strategy. As we are withdrawing 
the proposal for a comprehensive quality strategy, but retaining the 
requirement for a managed care quality strategy, we will adjust this 
language in Sec.  438.340 to reflect this policy.
    Comment: One commenter recommended that the comprehensive quality 
strategy be posted on the state's Web site and urged CMS to require an 
annual publication and an archive of previous iterations of the state's 
quality strategy on the state Web site.
    Response: We thank the commenter for supporting the posting of the 
comprehensive quality strategy on a state's Medicaid Web site. We 
retain this requirement for the managed care quality strategies under 
Sec.  438.340(d) of the final rule. While we understand the interest 
and potential usefulness of an online archive of previous quality 
strategies, it may be administratively burdensome to require states to 
post and maintain these documents online. We believe posting the most 
current state managed care quality strategy online ensures access and 
transparency for the public, and decline the commenters' 
recommendation.
    Comment: One commenter recommended that CMS pick 2 or 3 states to 
serve as a pilot project, to determine if the comprehensive quality 
strategy and its costs result in any actual benefit.
    Response: We appreciate the commenter's recommendation. While we 
are withdrawing the proposed comprehensive quality strategy, and do not 
intend to create a pilot program, states can elect to create a 
comprehensive quality strategy. Such a strategy also may be required 
under a section 1115(a) demonstration.
    Comment: A few commenters recommended allowing states between 2 and 
5 years to develop a comprehensive quality strategy as envisioned in 
the proposed rule. Commenters recommended that CMS collaborate with 
states and/or medical directors to: (1) Support implementation of the 
comprehensive quality strategy; (2) develop a framework; (3) develop 
policies and procedures to support the comprehensive quality strategy; 
and (4) provide an adequate phase-in for the development and deployment 
of the comprehensive quality strategy. One commenter recommended that 
CMS provide adequate technical assistance to achieve the desired 
results.
    Response: We appreciate the concern for adequate support and time 
for states to implement a comprehensive quality strategy. We are 
withdrawing the proposal for a comprehensive quality strategy, and 
therefore believe that existing resources will be sufficient to assist 
states in future revisions of their managed care quality strategies. 
Given that we are retaining the managed care quality strategy, which 
exists under current regulations, we believe that a state must come 
into compliance with the revised quality strategy provisions no later 
than July 1, 2018.
    We are moving the requirements in proposed Sec.  431.504 to Sec.  
438.340(c) and (d) to reflect the retention of only the managed care 
quality strategy in the final rule, with revisions discussed above and 
for clarity.
(4) Applicability to Medicaid Managed Care Programs (New Sec.  431.506)
    To reduce the burden on states contracting with managed care 
entities and to ensure that the comprehensive quality strategy 
addresses all populations, we proposed to cross-reference the elements 
of the managed care quality strategy applicable to states that contract 
with MCOs, PIHPs, PAHPs, and certain PCCM entities to deliver Medicaid 
services. Under proposed Sec.  431.506, states contracting with one of 
these managed care entities would be able to create a managed care 
quality strategy by incorporating the part 438 elements into the 
larger, comprehensive quality strategy.
    We received the following comments in response to our proposed 
Sec.  431.506.
    Comment: Several commenters expressed support for this section, 
specifically: (1) The application to managed care programs as defined 
in Sec.  438.2 to include the full range of applicable waivers; (2) 
incorporating the managed care quality strategy elements into the 
larger comprehensive quality strategy and CMS' offer of technical 
assistance; and (3) the ability to compare performance across delivery 
systems.
    Response: We thank the commenters for expressing support for the 
inclusion of the managed care quality strategies in the comprehensive 
quality strategy. Consistent with our decision to withdraw the 
requirements for a comprehensive quality strategy, we are withdrawing 
this section.
    After consideration of the public comments on part 431 subpart I, 
we are striking this proposed section, consistent with our decision to 
withdraw the proposed requirement for a comprehensive quality strategy. 
Since this paragraph only cross-referenced Sec.  438.340 but did not 
include any additional requirements for a comprehensive or managed care 
quality strategy, none of this language will be retained in Sec.  
438.340 in the final rule.
(g) Managed Care Elements of State Comprehensive Quality Strategies 
(New Sec.  438.340, Formerly Sec.  438.204)
    Section 438.204 of the current regulations identifies the minimum 
elements of a managed care state quality strategy, including: (1) MCO 
and PIHP contract provisions that incorporate the standards in existing 
part 438 subpart D; (2) procedures for assessing the quality and 
appropriateness of care and services furnished to all enrollees under 
the contract; providing information about the race, ethnicity and 
language of beneficiaries to MCOs and PIHPs at the time of enrollment; 
and regular monitoring and evaluation of MCO and PIHP compliance with 
the standards in subpart D; (3) specification of any national 
performance measures identified by CMS; (4) arrangements for annual, 
external independent reviews of quality outcomes, and timeliness of, 
and access to, services provided by each MCO and PIHP; (5) appropriate 
use of intermediate sanctions for MCOs; (6) an information system 
sufficient to support initial and ongoing operation and review of the 
state's quality strategy; and (7) standards, at least as stringent as 
those under the applicable subpart D of the regulations.
    Consistent with our proposal in part 431 subpart I, we proposed to 
title this section ``managed care elements of the state comprehensive 
quality strategy''. We also proposed to extend the quality strategy 
requirements to states contracting with PAHPs. Consistent with the 
current structure of Sec.  438.204 (that is, a list of the elements 
required in a quality strategy), we proposed to move the quality 
strategy elements specific to managed care to proposed Sec.  438.340 
(those applicable to managed care and FFS were moved to proposed

[[Page 27701]]

Sec.  438.502). We also proposed to remove some of the existing quality 
strategy elements.
    In paragraph (a), we proposed that states include in their 
comprehensive quality strategy the network adequacy and availability of 
service standards and examples of evidence-based clinical practice 
guidelines that its managed care plans follow. We proposed that the 
content of existing Sec.  438.204(b)(1) was captured in proposed part 
431 subpart I. We proposed deleting reference to the information 
previously found in Sec. Sec.  438.204(b)(2) and (b)(3).
    In Sec.  438.340(b), we proposed that the state's goals and 
objectives developed under proposed Sec.  431.502(b)(i) incorporate a 
description of quality metrics and performance targets that the state 
will use to assess Medicaid managed care quality, including any 
performance measures required by the state in accordance with proposed 
Sec.  438.330(c) and any PIPs required by the state in accordance with 
proposed Sec.  438.330(d). Proposed Sec.  438.340(b) would replace 
Sec.  438.204(c) of the current regulations. We proposed redesignating 
current Sec.  438.204(d) and (e) at Sec.  438.340(c) and (d), 
respectively, and to expand the external review element in proposed 
Sec.  438.340(c) to PAHP contracts as well. We proposed to eliminate 
the text previously found in Sec.  438.204(g) as redundant with 
proposed Sec.  438.340(a). Finally, in paragraph (e), we proposed that 
states address how they would assess the performance and quality 
outcomes achieved by each PCCM entity, to conform to other changes made 
in this part.
    We received the following comments in response to proposed Sec.  
438.340.
    Comment: Several commenters expressed broad support for the 
proposed comprehensive quality strategy requirements and the managed 
care elements of the comprehensive quality strategy.
    Response: We appreciate the commenters support for the managed care 
quality strategy elements. We retain these items in this final rule.
    Comment: One commenter asked whether CMS will provide states with a 
reporting template for the comprehensive quality strategy. Another 
commenter referenced guidance that CMS provided to states last year in 
the form of questions to assure that each state submitted appropriate 
required information. This commenter recommended that CMS continue this 
standardized format, as it will be easier for CMS to review and easier 
for states to compare their answers with answers from other states. 
Several commenters requested that CMS clarify the relationship between 
the state-chosen quality metrics described in Sec.  431.502(b)(2) and 
the state-selected metrics described in Sec.  438.330(a)(2). They were 
not clear as to whether or how metrics selected in the CMS public 
comment process described in Sec.  438.330(a)(2) would apply to 
Medicaid FFS in a state.
    Response: We appreciate the support for our previous technical 
assistance to states regarding the managed care quality strategy. While 
we do not intend to release a template for the quality strategy, we 
plan to issue a revised quality strategy toolkit which will assist 
states in complying with the quality strategy standards in Sec.  
438.340. Because we are withdrawing the proposed comprehensive quality 
strategy, there is no need to reconcile how the measures identified 
under the authority of proposed Sec.  438.330(a)(2) would apply to FFS 
in a state. However, while we are withdrawing proposed Sec.  431.502, 
we do retain the requirement in proposed Sec.  431.502(b)(2) (relating 
to specific quality metrics and performance targets, including those to 
be posted on the state's Web site) in Sec.  438.340(b)(4) of the final 
rule. Should we elect to identify any performance measures under Sec.  
438.330(a)(2), states must require those measures be included in their 
plans' QAPI programs, and in turn must be reflected in the state's 
quality strategy. Under Sec.  438.340(b)(3)(i), if CMS identifies 
measures under Sec.  438.330(a)(2), a state could rely on the measures 
identified by CMS under Sec.  438.330(a)(2) or use a mix of nationally 
identified and state-selected metrics.
    Comment: Two commenters expressed concern that CMS did not propose 
to include in Sec.  438.340 the current provision under Sec.  
438.204(b)(2) that requires states to identify for plans the race, 
ethnicity, and primary language spoken by Medicaid beneficiaries. One 
commenter stated that removing the current reporting requirement for 
states to provide plans with relevant identifying information will 
impact the provision of culturally competent care to Medicaid 
beneficiaries because immediate knowledge of a person's race, 
ethnicity, and primary language are especially important for case 
managers who are coordinating care and identifying appropriate 
physicians for beneficiaries. Another commenter believes that the 
provision is necessary for quality improvement activities aimed at 
reducing health disparities. The commenter said that states should be 
required to collect this information at the time of enrollment and 
share it with the MCOs. The commenters recommended that CMS include the 
requirement in current Sec.  438.204(b)(2) in the final rule.
    Response: We agree with the commenters that information about a 
beneficiary's race, ethnicity, and primary language are important to 
ensuring appropriate care and services for beneficiaries. In response 
to the comments, under Sec.  438.340(b)(6) of the final rule, states 
will be required to include in their quality strategy a plan to address 
health disparities on the basis of age, race, ethnicity, sex, primary 
language, and disability status. We also agree with commenters that the 
current communication requirement is an important element; therefore, 
we are also including at Sec.  438.340(b)(6) of the final rule the 
current requirement that states provide key demographic information to 
the MCO, PIHP, or PAHP for each of their Medicaid enrollees at the time 
of enrollment.
    Comment: With regard to proposed paragraph Sec.  438.340(a), one 
commenter stated concern that proposed Sec.  438.340 includes a focus 
on adherence to clinical guidelines, which may not best serve 
individual patients whose situations require more individualized care. 
The commenter urged CMS not to rely on adherence to treatment 
guidelines as a measure of quality for all patients.
    Response: We appreciate this opportunity to clarify the reference 
to clinical practice guidelines in proposed Sec.  438.340(a) (finalized 
at Sec.  438.340(b)(1)). Each state's quality strategy is required to 
include examples of these guidelines, but does not require adherence to 
these guidelines. We did not propose and do not intend to rely on 
adherence to clinical practice guidelines as a measure of quality for 
all beneficiaries for exactly the reason presented by the commenter.
    Comment: Several commenters agreed with CMS that network adequacy 
and availability of service standards are useful quality measures, and 
expressed support for including these access metrics. A few commenters 
encouraged CMS to require that states must consider all populations 
served by Medicaid when reviewing network adequacy and availability of 
service standards.
    Response: We appreciate the commenters' support for the inclusion 
of network adequacy and availability of services standards in the 
quality strategy. Section 438.68(c) of the final regulation requires 
that states take into consideration a number of factors in developing 
their network adequacy standards, including anticipated

[[Page 27702]]

enrollment, characteristics and health care needs of specific Medicaid 
populations enrolled in managed care plans. The availability of 
services standards in Sec.  438.206 require that states ensure that 
their managed care plans maintain a network of providers sufficient to 
meet the need for all covered services under the contract for all 
enrollees, including persons with disabilities. We believe that this 
language is sufficient to ensure that all populations are addressed in 
these standards, which are then incorporated into the quality strategy.
    Comment: One commenter encouraged CMS to have similar quality 
improvement requirements for Medicaid and Medicare.
    Response: As a part of the development of the proposed rule, we 
compared the quality improvement requirements for Medicaid with those 
of Medicare. We believe that we have aligned these standards as much as 
possible considering the distinct and different natures of these 
programs.
    Comment: Several commenters expressed support for proposed Sec.  
438.340(b). One commenter encouraged CMCS to be thoughtful and balanced 
in the selection of quality measures to ensure actual quality 
improvement and reduce unintended consequences. One commenter 
recommended that CMS include measures and steps being taken to keep 
people in their communities in the least restrictive environment 
possible. Another commenter recommended that CMS also include CMS Child 
Core Set measures, and recommended that all measures be properly vetted 
by providers and payers and endorsed by an independent entity such as 
the NQF. The commenter believes these actions would encourage and 
foster clear expectations, more precise specifications and 
accountability.
    Response: We thank the commenters for their support of proposed 
Sec.  438.340(b) (Sec.  438.340(b)(2) in the final rule). While the 
identification of specific performance measures is outside of the scope 
of this rulemaking, Sec.  438.330(a)(2) provides for a public notice 
and comment process through which we can engage states and other 
stakeholders in the identification of national performance measures and 
PIP topics, which would be incorporated into a state's managed care 
quality strategy in accordance with Sec.  438.340(b)(2).
    Comment: Two commenters suggested that we remove the requirement in 
proposed Sec.  438.340(b)(2) that states include in their quality 
strategy interventions that they propose to achieve improvement. The 
commenters believe that states should proposed broad PIP topics, but 
not specific interventions, which instead should be based on a barrier 
analysis conducted by each managed care plan.
    Response: We understand that states today take a variety of 
approaches to the PIPs conducted by their managed care plans, ranging 
from leaving the determination up to the plan to specifying topics, 
interventions, and metrics. We did not intend to limit this flexibility 
through this language, and proposed Sec.  438.340(b)(2) does not 
require that states prescribe specific interventions. Rather, proposed 
Sec.  438.340(b)(2), finalized without substantive revision at Sec.  
438.340(b)(3)(ii), requires only that states include a description in 
their quality strategies of any interventions that the state elects to 
require, if any. If a state does not specify any specific 
interventions, Sec.  438.340(b)(2) only requires the state to describe 
the PIPs to be implemented in accordance with Sec.  438.330(d).
    Comment: One commenter suggested that there may be misalignment 
between the date of the quality strategy and the interventions, ``which 
by necessity should be additive and/or refreshed over time and perhaps 
before the quality strategy is updated.''
    Response: We do not agree with the comment. The quality strategy is 
not a static document, but must be updated at least once every 3 years 
and whenever a ``significant change'' is made. To the extent to which 
new strategies emerge or a given strategy is no longer appropriate for 
a state, we would expect the state to update its strategy accordingly.
    Comment: One commenter requested that CMS cross-reference Sec.  
438.350 in Sec.  438.340(c) to make clear that Sec.  438.340(c) is 
specifically referring to EQR and does not establish an additional 
requirement which must be included in a state's quality strategy.
    Response: We have added the requested cross-reference.
    Comment: One commenter expressed ``qualified'' support for the 
proposed inclusion of appropriate use of intermediate sanctions in 
proposed Sec.  438.340(d).
    Response: This element of the managed care quality strategy exists 
under current regulations in Sec.  438.204(e). We appreciate the 
commenter's support for this item, which we will retain without 
medication in this final rule.
    After consideration of the public comments, we are finalizing this 
section as proposed, with the following modifications: (1) The 
inclusion of language from proposed Sec. Sec.  431.502 and 431.504 with 
modification as discussed in sections I.B.6.b(f)(2) and (3) of this 
preamble; (2) renumbering of paragraphs to address the addition of the 
language from proposed Sec. Sec.  431.502 and 431.504; (3) modifying 
Sec.  438.340(b)(6) to retain the requirement, previously at Sec.  
438.204(b)(2), that states provide plans with specific demographic 
information about enrollees; (4) adding a cross-reference to Sec.  
438.350 to paragraph (b)(4) (paragraph (c) in the proposed rule); and 
(5) adding cross-references to other sections in part 438 which 
identify information that must be included in a state's quality 
strategy. We are also revising the title of this section to ``Managed 
care State quality strategy'' to reflect the content of this section in 
the final rule.
(h) External Quality Review (Sec.  438.350)
    In Sec.  438.350, we proposed to modify the title of the section 
that identifies the state's responsibilities related to EQR to clarify 
that these responsibilities are specific to the EQR process. In 
addition to proposing the application of EQR to PAHPs, consistent with 
our proposal discussed in Sec.  438.310, we proposed a minor 
restructuring of Sec.  438.350 and a few substantive changes. We 
proposed to redesignate existing paragraphs (a) through (f) as (a)(1) 
through (a)(6). In paragraph (a)(3), we proposed that information from 
Medicare or private accreditation reviews is a permissible source of 
information for use in the EQR, in addition to information gathered 
from the EQR-related activities as described in Sec.  438.358. We also 
proposed clarification in (a)(4) that the information gathered from 
each EQR-related activity is for use in the EQR and resulting EQR 
technical report. Finally, in paragraph (b), we proposed to add that if 
a state chooses to perform an EQR on a PCCM entity, the standards laid 
out in paragraphs (a)(2) through (6) would apply.
    We received the following comments in response to our proposal to 
revise Sec.  438.350.
    Comment: Several commenters offered general support for the changes 
under 438.350.
    Response: We appreciate the commenters' support for the proposed 
revisions to this section, which we are finalizing with some revisions, 
discussed below.
    Comment: One commenter supported use of information from Medicare 
or private accreditation review as a source of information for use in 
the EQR.

[[Page 27703]]

    Response: We are retaining this flexibility in Sec.  438.350(a)(3) 
of the final rule, consistent with section 1932(c)(2)(B) of the Act, 
which we are finalizing as proposed except for a non-substantive 
revision discussed below.
    Comment: A few commenters requested that CMS take action in the 
regulations to more clearly eliminate and/or reduce the overlap that is 
inherent in the new quality assurance requirements of the proposed 
rules and the existing EQR requirements, to promote the efficient use 
of resources.
    Response: We appreciate commenters' concern regarding overlap 
between the new and existing EQR requirements and believe we accounted 
for this in aligning quality related activities in the managed care 
quality strategy components, the MMC QRS, and expanded use of 
accreditation information in EQR. Specifically, consistent with section 
1932(c)(2)(B) of the Act, Sec.  438.360 of the final rule provides 
states with the option to use information from either a private 
accreditation or Medicare review in place of information which would 
otherwise be generated by the activities required under Sec.  438.358. 
Consistent with section 1932(c)(2)(C) of the Act, Sec.  438.362 of the 
final rule provides states with the option to exempt MCOs from EQR 
activities under specific circumstances. Beyond these areas, we believe 
that the quality requirements, while interrelated, are distinct and 
each are necessary to ensure appropriate and thorough oversight and 
monitoring of quality, access and timeliness of care for beneficiaries 
enrolled in Medicaid managed care plan.
    Comment: A few commenters stated that CMS should not force states 
to outsource quality review to another vendor which may diffuse 
oversight and accountability. One commenter noted that as the primary 
payer, the state has a vested interest in high-quality health care and 
should be able to conduct reviews of its contracted vendors using 
standards established by CMS.
    Response: We share the commenter's view that states have an 
interest in the provision of high quality care; but disagree with the 
characterization of the EQR process. Section 1932(c)(2) of the Act 
requires the annual external independent review conducted by a 
qualified independent entity. CMS is bound by statute to require states 
to contract with an EQRO to conduct the annual EQR as an independent 
review of the quality of the care provided; therefore we reject this 
comment. We note that under Sec. Sec.  438.356(a)(2) and 438.358(a)(1) 
of the final rule states enjoy considerable flexibility regarding the 
entities that can conduct the EQR-related activities described in Sec.  
438.358(b) and (c), which provide the data used for the annual EQR.
    Comment: A commenter recommended that PCCMs and other FFS providers 
be evaluated on similar metrics to the extent practicable to permit 
comparison among and between models providing Medicaid benefits. 
Several commenters recommended that CMS amend paragraph (b) of this 
section to stipulate that a PCCM entity be required to undergo EQR if 
it has a state contract that provides for shared savings, incentive 
payments or other financial reward for improved quality outcomes, with 
the option for exemption when states provide written evidence that EQR 
would be inappropriate. One commenter noted disagreement with the 
proposed language which allows states to have sole discretion over 
whether EQR should be required for such PCCM entities. The commenters 
recommend that the regulation should presume that PCCM entities with a 
financial stake in quality outcomes would be subject to EQR.
    Response: While we appreciate the commenter's interest in allowing 
comparison among and between care delivery models, we disagree that FFS 
providers should be subject to an EQR. The EQR assesses a Medicaid 
managed care plan; it is not designed or intended to evaluate the 
quality of care offered by individual providers. Similarly, while we do 
not agree that EQR activities generally are appropriate for PCCMs, we 
do agree that it is appropriate for the PCCM entities described in 
Sec.  438.3(r) of the proposed rule and Sec.  438.310(c)(2) of the 
final rule, specifically, PCCM entities whose contract with the state 
provides for shared savings, incentive payments or other financial 
reward for improved quality outcomes.
    Proposed Sec.  438.3(r) required that PCCM entities whose contract 
with the state provides for shared savings, incentive payments or other 
financial reward for improved quality outcomes be subject to EQR under 
this section. While the language in proposed Sec.  438.350(b), and its 
associated preamble, described EQR as an option for these PCCM 
entities, this was an error. Consistent with proposed Sec.  438.3(r), 
we intend that EQR of these PCCM entities be mandatory, with no 
flexibility for states to opt out of this requirement. Therefore, in 
the final rule we are striking proposed Sec.  438.350(b) and adding a 
reference to PCCM entities (described in Sec.  438.310(c)(2)) to the 
introductory text for Sec.  438.350 to require the annual EQR of select 
PCCM entities, which were described in Sec.  438.3(r) of the proposed 
rule but are now described in Sec.  438.310(c)(2) of the final rule.
    We are also revising Sec.  438.358(b) to clearly identify which 
mandatory EQR-related activities apply to PCCM entities (described in 
Sec.  438.310(c)(2)). Specifically, we are redesignating proposed 
paragraph (b) as (b)(1) and proposed paragraphs (b)(1) through (b)(4) 
as paragraphs (b)(1)(i) through (b)(1)(iv). We are also adding a new 
paragraph (b)(2), which specifies that performance measure validation 
(in paragraph (b)(1)(ii) of the final rule) and the compliance review 
(in paragraph (b)(1)(iii) of the final rule) must be conducted on PCCM 
entities (described in Sec.  438.310(c)(2)). PCCM entities (described 
in Sec.  438.310(c)(2)) are not subject to the PIP validation activity 
(paragraph (b)(1)(i) of the final rule) as they are not required to 
conduct PIPs. PCCM entities (described in Sec.  438.310(c)(2)) are not 
subject to the validation of network adequacy activity (paragraph 
(b)(1)(iv) of the final rule) as they are not subject to the network 
adequacy standards identified in Sec.  438.68.
    Comment: A few commenters recommended that CMS revise paragraph 
(a)(3) of this section to read: ``The information used to carry out the 
review must be obtained from the EQR-related activities described in 
Sec.  438.358 or, if applicable, from a Medicare or private 
accreditation review as described in Sec.  438.360.''
    Response: We believe that the recommended revision does not alter 
the intent of this paragraph but may increase clarity; therefore, we 
accept the recommended revision.
    Comment: A commenter stated that quality assurance that addresses 
the six characteristics of high performance care, (that is, safe, 
effective, efficient, personalized, timely and equitable), not only 
quality monitoring, needs to be in place. The commenter noted that 
several of these characteristics can only be assessed by querying 
patients and families; therefore, the commenters recommended that MCOs 
should be required to measure patient experience directly.
    Response: We appreciate the commenter's interest in requiring 
direct measurement of a beneficiary's experience toward the aims of 
high performance care. We anticipate that states will be required to 
measure beneficiary experience of care for the MMC QRS under Sec.  
438.334 of the final rule. EQR also includes, as an optional activity 
described in Sec.  438.358(c)(2), the administration or validation of 
consumer or provider surveys of quality of care, and some states 
utilize the

[[Page 27704]]

Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) 
survey as a part of their performance measurement programs. We believe 
these provisions relating to measurement of patient experience are 
sufficient and are not revising Sec.  438.350 in response to the 
comment.
    Comment: A commenter recommended CMS add a component to the EQR 
that would review state requirements, similar to the process defined 
for MCOs at Sec.  438.350. The commenter states that requiring and 
making publicly available the results of any such review will promote 
transparency and accountability.
    Response: We believe the commenter is requesting that states 
undergo an EQR, similar to the one conducted by an EQRO on an MCO. 
However, we disagree with this suggestion. Section 1932(c)(2) of the 
Act establishes the requirement for an annual external independent 
review of an MCO; we are responsible for overseeing a state's 
compliance with the requirements of the Medicaid program. CMS provides 
oversight of states' Medicaid managed care programs through the 
contract and rate certification review and approval processes. We also 
provide quality oversight through several existing and new activities, 
including: (1) Quality strategy review, consistent with final rule 
Sec.  438.340(c)(1)(iv); (2) review of the annual EQR technical reports 
published by states under Sec.  438.364(c); (3) review of EQRO 
contracts under Sec.  438.370(c); and (4) through our work with states 
on the collection and reporting of the CMS Child and Adult Core Measure 
Sets for Medicaid and CHIP. Given our role in oversight of state 
Medicaid programs, we decline the commenter's recommendation, and make 
no changes to this section.
    Comment: A commenter recommended CMS consider sanctions for poor 
performing plans based on EQR, poor performance reflected in the 
state's quality plan measures, HEDIS measures and/or member survey 
responses.
    Response: While section 1932(e) of the Act, as effectuated by part 
438 subpart I, requires that states contracting under section 1903(m) 
of the Act have authority to utilize intermediate sanctions to address 
managed care plan noncompliance, we have parallel authority under 
section 1903(m)(5) of the Act to impose intermediate sanctions and 
civil money penalties. While the regulations provide that such 
sanctions generally would be imposed when recommended by the state, we 
retain the authority to do so under Sec.  438.730(g)(1). We would be 
open to exercising this authority where determined appropriate in a 
case where we determine the state has not acted where it should have 
concerning an MCO not complying with the EQR process.
    After consideration of the public comments, and to clarify the 
application of this section to PCCM entities described in Sec.  
438.310(c)(2) of the final rule, we are: (1) Deleting paragraph (b) and 
instead adding PCCM entity described in Sec.  438.310(c)(2) to the list 
of impacted entities throughout this section; (2) not finalizing the 
proposed restructuring of section (a); and (3) revising final rule 
paragraph (c) of this section to clarify that the information used to 
carry out the annual EQR must be obtained from the EQR-related 
activities or, if applicable, from a Medicare or private accreditation 
review. This revision clarifies that the EQR of PCCM entities whose 
contract with the state provides for shared savings, incentive payments 
or other financial reward for improved quality outcomes (consistent 
with Sec.  438.3(r) of the proposed rule and Sec.  438.310(c)(2) of the 
final rule) is mandatory.
(i) External Quality Review Protocols (Sec.  438.352)
    We did not propose any changes to Sec.  438.352. This section sets 
forth the parameters for the EQR protocols. Protocols are detailed 
instructions from CMS for personnel to follow when performing the EQR-
related activities. Protocols must specify: (1) The data to be 
gathered; (2) the source of the data; (3) the activities and steps to 
be followed in collecting the data to promote its accuracy, validity, 
and reliability; (4) the proposed methods for valid analysis and 
interpretation of the data; and (5) all instructions, guidelines, 
worksheets and any other documents or tools necessary for implementing 
the protocol. Under section 1932(c)(2)(A)(iii) of the Act, the 
Secretary, in coordination with the National Governors' Association, 
contracts with an independent quality review organization to develop 
such protocols.
    We received the following comments on Sec.  438.352.
    Comment: Two commenters supported the unaltered continuation of 
this section. One commenter requested that CMS specify which entity 
develops the protocol: the state; the state's contractor; CMS; or CMS's 
contractor. The commenter suggested noting in the regulation that CMS 
will obtain input from states prior to finalizing the protocols. 
Another commenter suggested that if states are required to use these 
protocols, CMS should make this requirement explicit in Sec.  438.350 
or Sec.  438.352.
    Response: We did not propose revisions to Sec.  438.352, which is 
finalized as published in the proposed rule, except to make one small 
technical revision for clarity, noted below. However, we note that, in 
accordance with section 1932(c)(2)(A)(iii) of the Act, the Secretary, 
in coordination with the National Governors' Association (NGA), 
contracts with an independent quality review organization to develop 
the protocols. This process ensures state involvement in the EQR 
protocol development process. The Secretary is responsible under the 
statute for issuing the protocols; we are revising the introductory 
language in Sec.  438.352 of the final rule to clarify that the 
protocols are issued by the Secretary but are developed by the 
Secretary in coordination with NGA. We also note that the requirement 
that states use the EQR protocols is stated in Sec.  438.350(e), as 
finalized in this rulemaking, which provides that information provided 
to the EQRO for EQR must be obtained through methods consistent with 
the EQR protocols established under Sec.  438.352. We are also revising 
Sec.  438.350(e) to clarify that the Secretary issues the EQR 
protocols.
    After consideration of the public comments, we are making a 
technical correction to this section to clarify that the Secretary 
develops the protocols in consultation with NGA and that the protocols 
are issued by the Secretary.
(j) Qualifications of External Quality Review Organizations (Sec.  
438.354)
    We proposed two modifications to Sec.  438.354, which sets forth 
the competence and independence standards that an entity must meet to 
qualify as an EQRO. First, we proposed additional text, consistent with 
our overall proposal, to expand EQR to PAHPs. Second, in paragraph 
(c)(3)(iv), we proposed that an accrediting body may not also serve as 
an EQRO for a managed care plan it has accredited within the previous 3 
years. This is due to our proposal that an EQRO be allowed to use the 
results of an accreditation review to perform the final EQR analyses; 
the financial relationship between a managed care plan and its 
accrediting body should not influence the results of the EQR (or the 
information that is included in the resulting EQR technical report). We 
also proposed a corresponding redesignation of existing paragraph 
(c)(3)(iv) to (c)(3)(v).

[[Page 27705]]

    We received the following comments in response to our proposal to 
revise Sec.  438.354.
    Comment: A few commenters expressed general support for these 
proposals.
    Response: We thank the commenters for their support and are 
finalizing the proposed revisions to Sec.  438.354 with some 
modifications, discussed below.
    Comment: A few commenters recommended adding language to the 
independence protections at Sec.  438.354(c) to ensure that an 
organization with ties to an MCO, PIHP, or PAHP may not qualify as an 
EQRO to review competitors in the same service area. Other commenters 
recommended that the independence provision also list controlling 
relationships with PCCM entities as a disqualifying factor for EQROs, 
and suggest that similar additions may also be appropriate for other 
EQR sections. One commenter opposed allowing accrediting bodies to 
serve as EQROs, and stated that there was inherent possible conflict in 
having one sector both define the metrics of MCO quality and the same 
sector validating its quality results.
    Response: We agree that an EQRO with ties to an MCO, PIHP, or PAHP 
should not be permitted to review competitors of said MCO, PIHP, or 
PAHP that operate in the same service area, as this could undermine the 
fact or appearance of independence and impartiality. We are revising 
paragraph (c)(3)(i), redesignated as paragraph (c)(2)(i) in the final 
rule, of this section to reflect this recommendation, with the 
modification of state instead of service area. We preliminarily note 
that we inadvertently neglected to add PCCM entities (described in 
Sec.  438.310(c)(2) of the final rule) to the regulation text at 
proposed Sec.  438.354(c). We agree with the commenters that EQROs 
selected to review a PCCM entity must meet the same independence 
requirements as EQROs reviewing an MCO, PIHP, or PAHP; this was our 
intent under the proposed rule. We are therefore correcting this 
oversight throughout Sec.  438.354(c) of the final regulation, as the 
qualifications for EQROs apply equally to the entities reviewing a PCCM 
entity (described in Sec.  438.310(c)(2)) in accordance with Sec.  
438.350 of the final rule.
    Regarding the concerns about an accrediting body serving as an 
EQRO, we share the commenter's interest in ensuring impartiality, 
though we are uncertain what is meant by the statement that the 
accrediting body sector ``define[s] the metrics of MCO quality.'' 
Section 1932(c)(2)(iii) of the Act requires CMS to contract with an 
independent quality review organization, such as NCQA, to develop these 
protocols; however, consistent with Sec.  438.352, the EQR protocols 
are to be developed by the Secretary in coordination with the National 
Governor's Association. These protocols are ultimately issued by the 
Secretary, not by an accrediting body. Second, to ensure independence, 
proposed paragraph (c)(3)(iv) would require that the EQRO have not, 
within the previous 3 years, conducted an accreditation review of any 
MCO, PIHP, or PAHP contracted by the state. We believe that these 
provisions ensure that the same entity is not developing the EQR 
protocols and conducting EQR for plans it has accredited. We believe 
this sufficiently addresses the commenter's concern, and are finalizing 
paragraph (c)(3)(iv) as paragraph (c)(2)(iv) with nonsubstantive edits.
    Comment: A few commenters recommended adding the phrase ``or 
expected'' to paragraph (c)(3)(v) of the proposed rule, so that 
paragraph would require that an EQRO not have a present, or known or 
expected future, direct or indirect financial relationship with an MCO.
    Response: We did not propose revisions to the current regulation 
text at Sec.  438.354(c)(iv), redesignated at Sec.  438.354(c)(v) in 
this rulemaking and are not making any changes in the final rule. We 
also disagree with the addition of ``expected'' to the description of 
financial relationships. The current regulation already prohibits use 
of entities with a known future financial relationship with a managed 
care plan from serving as an EQRO. Introduction of the word 
``expected'' would serve to infuse an element of speculation and 
uncertainty that we do not believe could be clearly defined, applied, 
or enforced.
    After consideration of the public comments, we are adding PCCM 
entity described in Sec.  438.310(c)(2) to the list of managed care 
plans in Sec.  438.354(c) and adding a provision that an EQRO with ties 
to an MCO, PIHP, PAHP or PCCM entity (described in Sec.  438.310(c)(2)) 
cannot qualify to review competitors of its MCO, PIHP, PAHP, or PCCM 
entity operating in the same state. We are also making a technical 
clarification to paragraph (c), which does not alter the meaning of the 
rule, by redesignating proposed paragraphs (c)(1) and (c)(2) as 
paragraphs (c)(1)(i) and (c)(1)(ii), respectively. This redesignation 
necessitates the redesignation of paragraph (c)(3) as (c)(2).
(k) State Contract Options for External Quality Review (Sec.  438.356)
    Our proposed revisions to Sec.  438.356 would provide additional 
clarification to the existing EQRO contracting process. We proposed 
changing the title of this section to clarify that it is specific to 
EQR contracting. In paragraph (a)(2), we proposed adding that other 
entities, in addition to or instead of an EQRO (such as the state or 
its agent that is not an MCO, PIHP, or PAHP) may conduct the EQR-
related activities to comport with this same flexibility afforded to 
states in Sec.  438.358. In paragraph (e), we proposed the addition of 
a cross-reference to paragraph (a), with the addition of ``with an 
EQRO'' to make clear that the contract subject to the open, competitive 
process is the state's contract with the EQRO. We also, in paragraph 
(e), proposed to update the cross-reference to the part of 45 CFR that 
governs grants to state governments from part 74 to part 75, to reflect 
changes that occurred after the existing regulations were finalized.
    We received the following comments in response to our proposal to 
revise Sec.  438.356.
    Comment: One commenter offered general support for the proposed 
revisions in Sec.  438.356.
    Response: We appreciate the commenter's support.
    Comment: Two commenters supported the addition that other entities, 
in addition to or instead of any EQRO, may conduct EQR-related 
activities as set forth in Sec.  438.356(a)(2). One commenter noted 
that this flexibility is critical so that states can tailor their EQR 
processes to accommodate the differing structure of state Medicaid 
programs and their capacity needs.
    Response: We appreciate the commenters support for this provision, 
which is actually a clarification of existing policy regarding the 
entities able to conduct the EQR-related activities described in Sec.  
438.358. As discussed in the proposed rule, Sec.  438.358(a) provides 
that other entities (specifically the state or its agent that is not an 
MCO or PIHP) were already able to conduct the EQR-related activities 
described in Sec.  438.358(b) through (d). Therefore, the revision of 
Sec.  438.356(a)(2) does not represent a change in policy but instead 
ensures that this existing flexibility is described clearly and 
consistently in the regulation. It is important to note that EQR-
related activities conducted by a non-EQRO on any managed care plan are 
only eligible for the 50 percent match rate described in Sec.  
438.370(b).

[[Page 27706]]

    Comment: One commenter appreciated the additional flexibility in 
allowing other entities instead of an EQRO to conduct EQR-related 
activities, but also cautioned against potential conflicts of interest 
that may arise.
    Response: We appreciate the commenter's concern. It is important to 
note that while other entities may conduct the EQR-related activities, 
and that these entities are not subject to the competence and 
independence requirements of an EQRO (described in Sec.  438.354), the 
EQR-related activities produce information used in the annual EQR. The 
EQR may only be conducted by a qualified EQRO, and only a qualified 
EQRO may produce EQR results. This ensures that an independent and 
competent EQRO reviews the information produced by EQR-related 
activities (regardless of the entity that conducts the activities) and 
evaluates the quality, timeliness, and access to the care furnished by 
the managed care plan.
    Comment: One commenter noted that the proposed revisions in Sec.  
438.356 would provide more options for EQR contracting with the 
exception of the EQR Technical Report which must be done by an EQRO.
    Response: We disagree that the proposed revisions in Sec.  438.356 
provide more options for EQR contracting. The proposed revisions to 
Sec.  438.356(a)(2) do not represent a change in policy, but instead 
reflect the flexibility that already exists in Sec.  438.358(a). We 
agree that this flexibility does not extend to the EQR technical 
report. To ensure that the EQR technical report reflects an independent 
analysis of the quality, timeliness, and access to the care furnished 
by the managed care plan, only a qualified EQRO may produce an annual 
EQR technical report.
    Comment: One commenter noted that some states have contracted with 
the same EQRO for an extended period of time without a rebid of the 
contract. The commenter recommended that CMS specify in Sec.  
438.356(e) that contracts should be rebid at a regular interval.
    Response: We did not propose changes to paragraph (e) to require 
rebidding and are not making such a revision in the final rule. We 
believe that there may be both advantages and disadvantages to a state 
retaining the same EQRO for an extended period with or without a 
rebidding process. Provided that the entity is qualified and 
independent, we believe that it is appropriate for states to retain the 
degree of flexibility afforded under the current regulations to engage 
or to not engage in a rebidding process.
    Comment: Several commenters supported the proposed revisions and 
specifically mentioned their support for the requirement that states 
follow an open, competitive procurement process. Commenters noted that 
45 CFR part 75 requires that requests for proposals (RFPs) be 
publicized, but does not specify that states post RFPs on the state 
Medicaid Web site. Commenters recommended that the public should have a 
role in providing input on the RFPs. Some commenters requested that CMS 
specify in Sec.  438.356(e) that notwithstanding state law, the state 
agency shall post its RFPs on the state Web site and provide a 
reasonable public comment period prior to beginning the bidding 
process. Some commented that the public comment period should be at 
least 30 days prior to beginning the bidding process.
    Response: We appreciate commenters support for the proposed 
revision, and specifically for the open and competitive procurement 
process. We disagree with requiring states to post RFPs online for 
public comment prior to the bidding process, which we believe would be 
inconsistent with general contracting practices.
    After consideration of the public comments, we are finalizing this 
section as proposed.
(l) Activities Related to External Quality Review (Sec.  438.358)
    This section sets forth the activities that produce information 
that the EQRO must use to conduct the EQR, to draw conclusions 
regarding access, timeliness, and quality of services provided by 
managed care plans, and to draft the final EQR technical report. Under 
the 2003 final rule, there were three mandatory and five optional EQR-
related activities. The three mandatory EQR-related activities are: (1) 
Validation of performance improvement projects; (2) validation of 
performance measures; and (3) determination of compliance with the 
standards set forth in subpart D. The five optional activities are: (1) 
Validation of encounter data; (2) administration or validation of 
surveys; (3) calculation of additional performance measures; (4) 
conduct of additional PIPs; and (5) conduct focused studies of quality 
of care. Under paragraph (d) of this section, EQROs are permitted to 
provide technical assistance if the state directs. We proposed several 
changes to this section, including the addition of text to be 
consistent with our proposal to extend EQR to PAHPs.
    We proposed separating the current paragraph (a) into two 
paragraphs, the first of which would retain the language in the current 
general rule. Our proposed paragraph (a)(2) would clarify that the 
information resulting from the performance of the EQR-related 
activities will be used in accordance with Sec.  438.350(a)(3) to 
complete the EQR. In paragraph (b), we proposed minor technical changes 
to make clear that the mandatory activities will be performed for each 
MCO, PIHP, and PAHP. In paragraphs (b)(1) and (b)(2), we included 
reference to the proposed CMS-identified measures and PIPs, which may 
be developed by CMS, in consultation with the states and other 
stakeholders, through the public process as described in the proposed 
Sec.  438.330(a)(2). In paragraph (b)(3), we proposed that the 
mandatory compliance review would consist of an evaluation of the MCO, 
PIHP, and PAHP standards proposed in subpart D, and because we proposed 
moving the QAPI program standards to subpart E (as described in the 
proposed Sec.  438.330), we reference that section as well. This does 
not propose any significant change from what comprises the current 
compliance review activity.
    We proposed the addition of a new mandatory EQR-related activity in 
paragraph (b)(4), the analysis of which would be included in the annual 
EQR technical report in accordance with Sec.  438.364. This proposed 
EQR-related activity would validate MCO, PIHP, or PAHP network adequacy 
during the preceding 12 months to comply with the state standards 
developed in accordance with Sec.  438.68. An assessment of compliance 
with Sec.  438.206 (availability of services) would occur as part of 
the mandatory compliance review described in Sec.  438.358(b)(3); 
however, because the methods that are frequently used to do so are 
limited to the review of policies and procedures and onsite interviews 
of personnel, we proposed that this EQR-related activity would go 
beyond the compliance activity by directly evaluating and validating 
network adequacy on an annual basis. While the specifics of this 
activity would be identified in a new EQR protocol, we envision the 
inclusion of steps such as measurement of how effectively a plan is 
meeting a state's specific access standards (for example, time and 
distance standards), direct testing to determine the accuracy of 
network information maintained by managed care plans, and telephone 
calls to providers that either assess compliance with a specific 
standard, such as wait times for appointments, or assess the accuracy 
of provider information, such as whether a provider is participating in 
a plan.

[[Page 27707]]

    Finally, in paragraph (d), we proposed a minor technical change by 
clarifying that technical assistance may be provided by the EQRO to 
assist managed care plans in conducting activities that would produce 
information for the resulting EQR technical report.
    We received the following comments in response to our proposal to 
revise Sec.  438.358.
    Comment: Many commenters expressed general support for the changes 
under Sec.  438.358; a few commenters expressed strong support.
    Response: We thank the commenters for their support for this 
section as proposed, and note that we are finalizing this section with 
modification, as described below.
    Comment: A commenter stated that the identification by CMS of 
national performance measures and PIPs would be additional work for the 
contracting managed care plans, the state, and its EQRO.
    Response: We appreciate the commenter's concerns about the possible 
burden associated with the identification by CMS of national 
performance measures and PIP topics. We note that CMS has the authority 
today to identify and require these items, but to date has not chosen 
to exercise this authority. Under Sec.  438.330(a)(2), if we elect to 
identify these items, we will utilize a public notice and comment 
process and engage states and stakeholders in the selection of these 
national performance measures and PIP topics; therefore, states, plans, 
and EQROs will have an opportunity to make recommendations regarding 
the measures and topics, which should reduce the additional burden 
these items will impose, as well as time to collect data and report on 
such measures.
    Comment: A few commenters requested that CMS amend Sec.  438.358(b) 
to include PCCMs.
    Response: We agree that a technical correction would clarify the 
application of EQR-related activities under this section to certain 
PCCM entities (described in Sec.  438.310(c)(2) of the final rule). 
Consistent with revisions to Sec. Sec.  438.310(c)(2) and 438.350 of 
the final rule, we are modifying Sec.  438.358 to reflect the 
requirement that PCCM entities described in Sec.  438.310(c)(2) must 
undergo an annual EQR, which requires the information generated by the 
activities under this section. Specifically, we are renumbering 
paragraphs (b)(1) to (b)(4) as paragraphs (b)(1)(i) to (b)(1)(iv), and 
adding a new paragraph (b)(2) to specify that PCCM entities (described 
in Sec.  438.310(c)(2)) must undergo the EQR-related activities 
described in paragraphs (b)(1)(ii) (validation of performance measures) 
and (b)(1)(iii) (compliance review).
    Comment: Many commenters raised questions about or proposed 
methodologies for how to conduct the validation of network adequacy, 
including: (a) Direct test standards; (b) validation based on the 
managed care plan's submission required under Sec.  438.207; and (c) 
surveys of beneficiaries as part of the validation of network adequacy. 
One commenter requested clarification on how network adequacy will be 
assessed in situations where access to services and providers is less 
available overall, particularly for linguistic and physical access.
    Response: We thank the commenters for their questions and 
suggestions. The methodology for each EQR-related activity will be 
contained in an EQR protocol, which will be developed in accordance 
with Sec.  438.352 in a process that is outside of this rulemaking. 
Therefore, we will not include methodological details recommended by 
commenters in regulation.
    Comment: Several commenters requested that CMS not adopt the 
proposed network adequacy validation activity. A few commenters 
believed it was duplicative of the accreditation process. One commenter 
recommended that CMS delete the new mandatory activity because it is 
already covered as part of the EQR compliance reviews and state 
monitoring requirements described in Sec.  438.66(b)(10).
    Response: We understand commenters' concerns. Network adequacy 
validation is a key quality oversight and monitoring activity. The 
proposed rule differs from the current accreditation review and/or the 
EQR compliance review in that it would require direct annual assessment 
of network adequacy for compliance with state network standards, versus 
the policy and procedure reviews, site visits, and interviews that 
occur once every 3 years under accreditation surveys or EQR. The 
methodology for this new activity will be defined in a forthcoming EQR 
protocol issued under Sec.  438.352. Finally, as an annual EQR-related 
activity, the data produced will be included in a state's annual EQR 
technical report, which will increase the accessibility of this 
information. Since we do not believe this would be duplicative of 
existing quality efforts, this new mandatory activity will remain in 
the final rule.
    Comment: A few commenters stated that the creation of a new 
mandatory activity for validating network adequacy would not be 
necessary for states with existing managed care delivery models, and 
would be unnecessary, duplicative and an administrative burden for MCOs 
and states experienced in managed care. One noted that this activity 
would be unnecessary in states with regular network oversight, and 
recommends that this mandate not apply to states that perform regular 
network oversight, and that it be written more broadly to allow for 
existing oversight mechanisms rather than prescribing the use of the 
EQRO.
    Response: We understand the commenters' concern and interest in 
avoiding duplication of activities. States will have an opportunity for 
input on the protocol that is developed for this activity. The activity 
will supplement, but not duplicate, existing state oversight 
activities. Consistent with Sec.  438.358(a), states may conduct the 
EQR-related activities; if the state conducts its validation consistent 
with the forthcoming new EQR protocol, then that information can be 
used for the annual EQR. We believe it is important to continue with 
the existing mandatory compliance review activity that includes managed 
care plan network adequacy assessment from a policy and operations 
perspective so that states have a nationally accepted standard that 
plans meet at a minimum. To reduce duplication of effort, states can 
provide information from an accreditation review (in place of 
information generated by the EQR-related activities in Sec.  438.358 
provided that the information is comparable as discussed in Sec.  
438.360) to EQROs for the annual EQR process. States that have existing 
network adequacy review methodologies in place will have the 
opportunity to demonstrate how they are consistent with EQR protocols, 
and will be able to submit recommendations through the public comment 
process in the development of the new EQR protocol. The new activity 
will also be eligible for 75 percent administrative match per Sec.  
438.370. Therefore, we reject the commenters' view that this activity 
would create significant administrative burden for the state, but 
acknowledge a phased-in approach should be considered for implementing 
the new activity most effectively.
    Comment: A commenter was concerned about loopholes that can distort 
information on the adequacy of a MCO provider network. The commenter 
suggested that CMS require surveys be conducted by the MCO to determine 
the status of their provider networks.
    Response: We appreciate the commenter's concern. We understand that 
network development and

[[Page 27708]]

maintenance are important activities for managed care plans, and that 
gaps and challenges exist in measuring the adequacy of a provider 
network. As discussed earlier, details of the network adequacy 
validation methodology will be provided in a forthcoming EQR protocol, 
the development of which is outside the scope of this regulation. There 
will be an opportunity for public feedback during the development of 
the EQR protocols.
    Comment: A few commenters recommended that CMS not require the 
validation of network adequacy be an annual activity.
    Response: We disagree with the commenters' recommendation. We 
believe that one way this activity distinguishes itself from other 
network monitoring activities is its annual nature. Network changes can 
occur at any point in time and a less frequent cycle would provide less 
timely and useful information for action by a managed care plan or a 
state.
    Comment: A commenter noted annual reviews--while helpful--are 
always retrospective and should only be a supplement rather than a 
replacement for routine monthly network adequacy analyses.
    Response: We appreciate the commenter's observation about the 
timing of the EQR process. By adding a mandatory EQR-related activity 
for network adequacy validation, we are neither recommending nor 
requiring alteration of a state's existing network oversight processes. 
Instead, annual network validation is a tool that can help to improve 
oversight of managed care plan networks, and make that information more 
accessible to the public. We see this activity working in harmony with 
other monitoring activities to help ensure beneficiaries have timely 
access to high quality services.
    Comment: A commenter noted that states will need time to adjust 
their EQRO contracts to reflect the new required mandatory activity.
    Response: We understand that states will require time to adjust 
their EQRO contracts. This new activity will phase in after the release 
of the EQR protocol for the validation of network adequacy, which will 
provide states with time to do so. Depending on a state's reporting 
cycle, we expect that all states contracting with MCOs, PIHPs, and 
PAHPs will conduct and report on this activity within 2 years of the 
release of the EQR protocol.
    Comment: A commenter stated that the addition of a new, mandatory 
EQR-related activity would increase its EQRO budget to include this 
additional work. However, the commenter also stated that the additional 
burden to the state for the new validation activity would be offset by 
use of deeming requirements which would reduce necessity for the 
compliance review and performance measure validation, two existing EQR-
related activities.
    Response: We understand that, for states that elect to have their 
EQRO conduct the validation of network adequacy EQR-related activity, 
this will increase the cost of the EQRO contract. We note that in this 
situation, the network adequacy validation of MCOs, PIHPs, and PAHPs 
would be eligible for the 75 percent match rate under Sec.  438.370(a).
    Comment: A few commenters noted that while they are in favor of 
requiring states to validate quality information reported by MCO, PIHP, 
or PAHPs, they recommend that CMS develop stronger oversight to ensure 
that states are validating data and not simply relying on independently 
reported quality metrics.
    Response: We appreciate the commenters' concern about the 
importance of validated performance measure data. One of the mandatory 
EQR-related activities is the validation of performance measures, 
described in proposed paragraph Sec.  438.358(b)(2) and finalized as 
Sec.  438.358(b)(1)(ii). This activity must be conducted in a manner 
consistent with the protocols established under Sec.  438.352, and we 
believe that it is reasonable to allow states the flexibility in 
paragraph (a)(1) of this section to either conduct this EQR-related 
activity themselves, or to have an agent that is not an MCO, PIHP, 
PAHP, or PCCM entity (described in Sec.  438.310(c)(2)), or an EQRO 
conduct the activity.
    Comment: Multiple commenters requested the creation of additional 
new EQR-related activities: (a) Full review and accounting of 
grievances and appeals; (b) requiring states or EQROs to collect data 
directly from enrollees, in the form of focus groups or beneficiary 
surveys; and (c) a review and analysis of home care provider and other 
direct care workers' wage adequacy, opportunities for training and 
skill development, and their role in potential plan quality 
improvement.
    Response: We understand the value of information on grievances and 
appeals, beneficiary surveys, and on home care providers and other 
direct care workers; however, disagree with adding the requested items 
as mandatory EQR-related activities. States are required under Sec.  
438.66(b)(2) to have a monitoring system in place for oversight of 
managed care plans' appeal and grievance systems. States are also 
required to use information from member grievance and appeals logs to 
improve performance of their managed care plans (Sec.  438.66(c)(2)). 
We allow, as an optional EQR-related activity in paragraph (c)(2) of 
this section, the administration or validation of consumer or provider 
surveys of quality of care. Beneficiary surveys are a component of the 
current QHP QRS; in Sec.  438.334(a) we propose to align the MMC QRS 
with the QHP QRS components. Finally, under current regulations and 
under Sec.  438.358(c)(5) of this final rule, states have the 
flexibility, as an optional EQR-related activity, to elect to conduct a 
focus study related to home care providers, other direct care workers, 
or grievances and appeals. As such, states have an EQR mechanism for 
these types of analyses if they determine such an analysis would be 
appropriate for the state's program.
    Comment: A commenter recommended that CMS add a general provision 
in which states could propose optional EQR activities that could 
qualify for enhanced match for CMS review and approval that align with 
its quality strategy.
    Response: We appreciate the commenter's request for state 
flexibility; however, we do not have the authority to provide enhanced 
match for state-specific activities. The 75 percent match rate 
authorized by section 1903(a)(3)(C)(ii) of the Act applies to 
independent external reviews conducted under section 1932(c)(2) of the 
Act, which further requires, in paragraph (2)(A)(iii), the use of 
protocols developed by the Secretary. Therefore, states can only claim 
the 75 percent match under Sec.  438.370 for EQR-related activities 
described in Sec.  438.358 conducted by an EQRO consistent with the 
protocols issued per Sec.  438.352. Additional optional EQR-related 
activities not identified in Sec.  438.358 would not have an associated 
EQR protocol under Sec.  438.352, and therefore, could not be eligible 
for the 75 percent match. Therefore, we reject this recommendation.
    Comment: A commenter stated that CMS should strengthen the 
requirements of the EQR program, including requiring provider input and 
verification of provider issues in trying to assist members as they 
move through the system.
    Response: We believe this final rule strengthens the requirements 
of the EQR, which will improve the quality of, timeliness of, and 
access to care for Medicaid beneficiaries. We appreciate the role that 
providers offer in assisting beneficiaries to navigate the system and

[[Page 27709]]

in providing quality care to beneficiaries, however, we decline to add 
an EQR-related activity focused on the role of providers. However, we 
will consider this recommendation with all other public comments during 
the next revision to the EQR protocols under Sec.  438.352.
    After consideration of the public comments, we are finalizing this 
section as proposed, with several technical revisions: (1) We are 
modifying Sec.  438.358 to reflect that states require an annual EQR 
for PCCM entities described in Sec.  438.310(c)(2), consistent with 
Sec.  438.350 in the final rule; (2) we are clarifying in (a)(2) that 
the information produced by the EQR-related activities must be used in 
the annual EQR under Sec.  438.350, and that the information produced 
by the activities must at a minimum include the elements described in 
Sec.  438.364(a)(1)(i) through (iv); and (3) we are modifying (b)(4) of 
this section to reflect that the network adequacy validation should 
examine compliance with the requirements set forth in Sec.  438.14(b), 
which addresses network requirements for managed care plan contracts 
involving Indians, Indian health care providers (IHCPs), and Indian 
managed care entities (IMCEs).
(m) Non-Duplication of Mandatory Activities (Sec.  438.360)
    This section is based on section 1932(c)(2)(B) of the Act, which 
provides the option for states to exempt MCOs from EQR-related 
activities that would duplicate activities conducted as a part of a 
Medicare review conducted of an MA plan or a private accreditation 
survey. In 68 FR 3586 (published January 24, 2003), to avoid 
duplication of work, states were given the option of using information 
about contracted MCOs or PIHPs obtained from a Medicare or private 
accreditation review to provide information which would otherwise be 
gathered from performing the mandatory EQR-related compliance review, 
but not for the validation of performance measures or PIPs. In 
addition, for MCOs or PIHPs that exclusively serve dual eligible 
beneficiaries, states may use information obtained from the Medicare 
program in place of information otherwise gathered from performing the 
mandatory EQR-related activities of validating performance measures and 
validating PIPs.
    We proposed giving states the option to rely on information 
obtained from a review performed by Medicare or a private accrediting 
entity to support performing the three existing mandatory EQR-related 
activities: (1) The validation of PIPs; (2) the validation of 
performance measures; and (3) the compliance review. For further 
discussion of this proposed change, see section I.b.6.b.2.m of the June 
1, 2015 proposed rule (80 FR 31098).
    We proposed in paragraph (a) that the state may use information 
about an MCO, PIHP, or PAHP obtained from a Medicare or private 
accreditation review within the past 3 years to support collection of 
information that would be obtained by completing one or more of the 
three existing EQR-related mandatory activities. We did not propose 
extending this option for non-duplication to the fourth, newly proposed 
EQR-related mandatory activity for validation of network adequacy, as 
neither we nor private industry have enough experience to know how well 
it would line up with current accreditation standards.
    Because of our proposal to extend the non-duplication option to 
three mandatory activities, we proposed to combine and streamline the 
content in the current Sec.  438.360(b) and (c), as it would no longer 
be necessary to separately address plans serving only dual eligibles. 
In paragraph (b)(1), we proposed clarifying that the Medicare or 
private accreditation review standards must be substantially comparable 
to the standards for the three EQR-related activities to be eligible 
for non-duplication. Finally, we retain that states identify whether 
they opt to deem portions of any of the EQR-related activities under 
this option, and include the reasons for doing so, in the comprehensive 
quality strategy. This redesignated the previous Sec.  438.360(b)(4) 
and (c)(4) to paragraph (c).
    We received the following comments in response to our proposal to 
revise Sec.  438.360.
    Comment: Multiple commenters expressed support for the expansion of 
nonduplication to the mandatory EQR-related activities of validation of 
PIPs (proposed Sec.  438.358(b)(1)) and performance measures (proposed 
Sec.  438.358(b)(2)). They indicated that this would improve efficiency 
and alignment, reduce redundancies, generate financial and time 
savings, and reduce the overall administrative burden on plans and 
states.
    A number of other commenters expressed opposition to the expansion 
of nonduplication to either the mandatory EQR-related activities of 
validation of PIPs (proposed Sec.  438.358(b)(1)), performance measures 
(proposed Sec.  438.358(b)(2)), or both. Concerns that were submitted 
include: (1) Use of proprietary private standards in EQR that can't be 
publicly compared to the CMS EQR Protocols; (2) questions about the 
independence of validation tests from private accreditors when 
accreditation survey or a HEDIS audit paid for by the plan could 
represent a potential conflict of interest; and (3) a potential for 
increased time lag in use of information from private accreditation 
within the previous 3 years, in lieu of mandatory EQR activities under 
EQR to validate performance measures and PIPs annually.
    Several commenters recommended that CMS revert to the current 
nonduplication provision, with the added requirement that information 
from an authorized private accreditor used in lieu of an EQR-related 
activity must come from entities that meet the independence and 
competency standards in Sec.  438.354, except Sec.  
438.354(c)(3)(iv)(which relates to accreditation).
    Response: We thank the commenters for their careful consideration 
of the proposed expansion of nonduplication to the validation of 
performance measures and PIPs. Section 1932(c)(2)(B) of the Act 
provides states the option to not conduct EQR-related activities which 
would be duplicative of review activities conducted as a part of the 
accreditation process or Medicare external review. This applies even if 
private accreditation standards are not publicly available and even 
when the information is generated by an accreditation review paid for 
by a Medicaid managed care plan. We note that paragraph (c) of this 
section requires a state to document its rationale for the use of the 
nonduplication provision in its quality strategy, and that the quality 
strategy, consistent with Sec.  438.340, is a public document; this 
affords the public an opportunity to review and comment on the state's 
determination and rationale. It also provides a forum for the public to 
comment on any impartiality concerns.
    Paragraph (b)(1) of the proposed rule, finalized as paragraph 
(a)(2) of this section, requires that for the state to rely on 
information from a Medicare review or private accreditation, the 
standards for that review must be comparable to the standards for the 
EQR-related activities, consistent with the EQR protocols issued per 
Sec.  438.352. We intend to provide guidance on comparability for the 
mandatory EQR-related activities in Sec.  438.358 (b)(1) to (b)(3) 
through future EQR protocols required under Sec.  438.352. This will 
address concerns raised relating to the transparency, timeliness and 
independence of accreditation results, and how the information from an

[[Page 27710]]

accreditation review may be used in the annual EQR.
    Finally, Sec.  438.358(a)(1) of the final rule allows a state, its 
agent that is not an MCO, PIHP, or PAHP, or an EQRO to conduct the 
mandatory and optional EQR-related activities. This allows an entity 
that does not meet the independence and competency standards in Sec.  
438.354 to conduct these activities. Given this flexibility, we do not 
believe the standards in Sec.  438.354 should apply to accreditation 
entities whose information is used under this section. Furthermore, 
section 1932(c)(2)(B) of the Act refers to accreditation by a private 
independent entity such as those described in section 1852(e)(4) of the 
Act; we do not believe we have the authority to impose additional 
restrictions based on the standards in Sec.  438.354.
    We are finalizing this section with revision to clarify that 
nonduplication is to be used at the state's discretion and consistent 
with guidance issued by the Secretary under Sec.  438.352.
    Comment: Several commenters noted that it is unclear if the 
accreditation referred to in this section would be specific to a plan's 
Medicaid line of business. Concern was raised as to how the validations 
of PIPs and performance measures applied to a population covered in the 
private market can be considered duplicative of validation of these 
measures for a Medicaid-specific population. Several commenters noted 
that in the previous rule-making that finalized the current 
regulations, HHS justified excluding these activities from the non-
duplication provision because the private accreditation review often 
encompasses an MCO or PIHP's private market line of business. HHS 
stated that the population served by private market insurance is 
dissimilar to the population served by Medicaid, and that EQR should 
only evaluate performance measures and PIPs specific to the Medicaid 
population. The commenters stated that it is not clear what has changed 
to justify this proposed policy change.
    Response: We thank commenters for noting historical reference to 
why use of private accreditation standards were not previously included 
for validation of performance measures and PIPs. Since publication of 
the 2003 final rule, at least two private accrediting entities have 
made available standards specific to the Medicaid line of business. We 
will issue guidance to states regarding the comparability of 
accreditation information to the information generated by the mandatory 
EQR-related activities in Sec.  438.358(b)(1)(i) through (b)(1)(iii) 
through future EQR protocols issued per Sec.  438.352. If the 
information generated by the accreditation review is not comparable to 
the information generated by an EQR-related activity, then the state 
must ensure that activity is applied to the managed care plan. 
Nonduplication provides a mechanism to reduce administrative burden to 
managed care plans and states while still ensuring relevant information 
is available to EQROs for the annual EQR. We are finalizing this 
section with modification to clarify that nonduplication is to be used 
at the state's discretion and consistent with guidance issued by the 
Secretary under Sec.  438.352.
    Comment: A number of commenters expressed concern over the 
interaction between the state review and approval process (including 
the use of accreditation) and nonduplication. These commenters believe 
that: (1) Private accreditation should not be allowed to be substituted 
for EQR-related activities; (2) states should not be allowed to deem 
plan compliance with EQR based on accreditation; and (3) accreditation 
should not undermine or effectively replace independent EQR or other 
quality assurance efforts. Several expressed concern that 
nonduplication weakens the EQR process. Other commenters stated that 
the expansion of nonduplication appears to directly contradict and 
undermine other proposed changes intended to strengthen the EQR 
process.
    Response: As discussed in section I.B.6.b.(2)(d) of the preamble, 
we are withdrawing the proposed state review and approval process in 
Sec.  438.332 (though we are retaining this section to require the 
availability of information regarding the accreditation status of a 
managed care plan). States currently have flexibility to require 
managed care plans to be accredited or not, and this flexibility will 
remain. Section 1932(c)(2)(B) of the Act grants states the option to 
not duplicate, through EQR-related activities, activities that are 
conducted as a part of an accreditation process or Medicare review. The 
expansion of nonduplication to the mandatory EQR-related activities of 
validation of PIPs (Sec.  438.358(b)(1)(i)) and performance measures 
(Sec.  438.358(b)(1)(ii)) for all Medicaid managed care MCOs, PIHPs, 
and PAHPs, not just those serving only dual eligibles, will provide 
additional flexibility to states to reduce administrative burden. We do 
not believe it undermines changes which strengthen the EQR process as 
information from a private accreditation review may only be used if it 
is comparable to the information generated by an EQR-related activity; 
if it is not comparable, the activity must occur.
    Comment: One commenter expressed concern that the use of 
nonduplication could pose a challenge to an EQRO's ability to conduct 
an effective performance analysis of a managed care plan.
    Response: We disagree. States which exercise the nonduplication 
option are required under Sec.  438.360(b) of the final rule to ensure 
that the information obtained from the accrediting organization in lieu 
of conducting the EQR-related activity is provided to the EQRO and 
included in the analysis and report required under Sec.  438.364.
    Comment: One commenter recommended that CMS allow states to deem 
accreditation as sufficient for state quality purposes, which would 
reduce the burden on plans and states, avoid duplication of effort, and 
avoid measure fatigue. Another encouraged CMS to streamline EQR by 
allowing NCQA accreditation to demonstrate EQR compliance when the 
requirements are similar. This approach would reduce the burden on 
states and plans.
    Response: We agree with the commenter on aligning quality 
measurement and improvement opportunities and reducing burden to states 
and managed care plans where appropriate. However, private 
accreditation does not cover the full range of quality activities 
required under the regulations. Therefore, we disagree that 
accreditation alone should be sufficient to deem a plan fully compliant 
with all quality regulations. For example, per Sec.  438.364(a)(3) of 
the final rule, EQROs will need to provide recommendations for 
improving the quality of health care services furnished by each MCO, 
PIHP, or PAHP, as well as for how the state can target goals and 
objectives in the quality strategy to better support improvement in the 
quality, timeliness, and access to health care services furnished to 
Medicaid beneficiaries. Under Sec.  438.364(a)(5), the EQRO is tasked 
with providing an assessment of the degree to which each MCO, PIHP, or 
PAHP has addressed the recommendations made by the EQRO during the 
previous year's EQR. These activities, which are specific to Medicaid 
managed care plans under the regulations, are not accounted for in 
private accreditation survey processes at this time.
    Comment: A few commenters requested CMS create a process to review 
and formally recognize accreditation standards as they map to EQR 
requirements, or to work with states to develop a managed care plan 
checklist which could be used to deem

[[Page 27711]]

compliance. Several commenters requested clarification of how states 
will apply the ``substantially comparable'' standard in Sec.  
438.360(b)(1).
    Response: Given the number of accreditation standards available, 
and the frequency with which they may change, we do not believe a 
crosswalk would be the most efficient means of supporting 
nonduplication. Instead, we intend to provide guidance to states on 
comparability for the mandatory EQR-related activities in Sec.  438.358 
(b)(1) to (b)(3) through future EQR protocols required under Sec.  
438.352. States will continue to have flexibility within that guidance 
to determine which activities are duplicative. Technical assistance 
will be available to states through the quality strategy, which will, 
under Sec.  438.360(c) of the final rule, identify the state's use of 
nonduplication and the related rationale. We believe the EQR protocols 
are the best vehicle to provide comparability guidance, given that such 
guidance must be specific to the details in each protocol, and thus 
should be revised any time the protocols undergo revision. We are 
revising this section to reflect that the standards of the Medicare or 
accreditation review must be comparable (rather than substantially 
comparable) to those enumerated in the EQR protocols. We believe it is 
appropriate to remove the qualifier ``substantially'' in light of the 
future comparability guidance.
    Comment: One commenter requested additional information regarding 
which type of Medicare review would be acceptable to replace the EQR 
mandatory activities and the names of the private accreditation 
agencies that are certified to do a comparable review of activities.
    Response: The comparability guidance to be included in forthcoming 
EQR protocols issued per Sec.  438.352 will be applicable to both 
Medicare reviews and private accreditation. While CMS may recognize 
accrediting agencies for accreditation of QHPs in the Marketplace and 
for MA organizations (Sec.  422.157), there is no similar provision in 
the statute providing for us to formally recognize accrediting entities 
for Medicaid managed care plans. Therefore, we intend to issue 
comparability guidance for the mandatory EQR-related activities in 
Sec.  438.358 (b)(1) to (b)(3) through future EQR protocols required 
under Sec.  438.352 which would be applicable to multiple accreditation 
standards.
    Comment: A few commenters requested clarification of what would 
happen if a state requires other performance measures that are not part 
of HEDIS, and recommended that if states require LTSS or any other non-
HEDIS measures, the state should be responsible for contracting with an 
EQRO to separately validate all the required non-HEDIS measures. Some 
commenters expressed concern that accreditation data may not include 
information related to LTSS. Relatedly, a few commenters requested 
guidance on how to address areas where Medicaid quality standards and 
accreditation standards do not overlap.
    Response: We appreciate this opportunity to clarify the application 
of the nonduplication provision. Information from a Medicare or 
accreditation review can be used in place of information generated by 
the EQR-related activity when the standards for the reviews are 
comparable to the standards for the EQR-related activity. If the 
standards are not comparable, then the EQR-related activity must occur. 
A state that chooses to utilize nonduplication and forwards information 
from an accreditation review to a contracted EQRO for the annual EQR 
must ensure the completion of any EQR-related activities (or components 
of those activities) which are not addressed by the information from 
the accreditation review. Therefore, if an accreditation review did not 
validate LTSS or other non-HEDIS measures required by the state under 
Sec.  438.330(b)(2) of this subpart, this EQR-related activity would 
need to be completed for these measures.
    Comment: One commenter requested clarification of how 
nonduplication will occur in light of any CMS-specific performance 
measures required under Sec.  438.330(a)(2). The measures accreditation 
entities use to examine performance might not align with the measures 
that are required by CMS; how would this lack of alignment be handled 
under the nonduplication option?
    Response: If there is a part of an EQR-related activity whose 
standards are not comparable to the standards of a Medicare or 
accreditation review, the state is required to complete that part of 
the EQR-related activity. In the scenario provided, if the measures 
identified by CMS per Sec.  438.330(a)(2) were not included in the 
accreditation review, then the state would be required to conduct the 
performance measure validation activity (Sec.  438.358(b)(1)(ii)) for 
these measures.
    Comment: One commenter believed that it is important to retain 
flexibility for MCO products serving sub-populations to select non-
standard measures that apply to the population being served.
    Response: This section would not limit the ability of a managed 
care plan serving sub-populations to select non-standard measures that 
are specific to the population served. However, we note that the plan 
would still be subject to measurement standards required by CMS and the 
state.
    Comment: A few commenters recommended that CMS allow nonduplication 
for the new EQR-related activity of network adequacy validation 
(proposed Sec.  438.358(b)(4)) for plans that are already accredited 
with a CMS-recognized accreditation body such as NCQA. Another 
commenter supported and applauded CMS for not extending nonduplication 
to the new network adequacy validation EQR-related activity.
    Response: Nonduplication can only be used in situations in which 
the standards for the Medicare or accreditation review are comparable 
to the standards for the EQR-related activity established through the 
EQR protocols. Since the EQR protocol for the new network adequacy 
validation activity (proposed, Sec.  438.358(b)(4), finalized as Sec.  
438.358(b)(1)(iv)) is pending and its standards are undefined, we 
decline the recommendation to allow nonduplication for the new EQR-
related activity.
    Comment: Several commenters recommended that, to avoid duplicative 
efforts and requirements, CMS should explore other opportunities for 
deeming based on accreditation. They recommend exploring opportunities 
for deeming: Within the proposed rule; within state oversight, 
management, and report requirements; and between federal programs. 
Alternatively, they suggested that CMS should require states to work 
with plans to identify duplication based on accreditation and then work 
towards a process for deeming.
    Response: We appreciate commenters' interest in reducing 
duplicative efforts. However, the authority for states to rely on 
private accreditation for quality-related provisions under section 
1932(c)(2)(B) of the Act is limited to mandatory EQR-related 
activities.
    Comment: Commenters recommended that CMS map each of the quality 
requirements and program monitoring activities under this rule to 
ensure plans are only required to be reviewed once for the same 
requirement or activity.
    Response: We have reviewed the quality requirements and program 
monitoring activities under this rule and believe that, while they may 
be interrelated, they are not duplicative.
    Comment: One commenter recommend that, in cases where a state uses 
information from an accreditation

[[Page 27712]]

review in place of information generated by the compliance review in 
proposed Sec.  438.358(b)(3), CMS should require the state to conduct 
additional direct testing of some aspect of a managed care plan's 
compliance each year.
    Response: We appreciate the commenter's interest in the use of 
direct testing as a means of supplementing the information from a 
Medicare or accreditation review used, under this section, in place of 
the EQR-related review of a managed care plan's compliance (finalized 
at Sec.  438.358(b)(1)(iii)). However, the intent of the nonduplication 
provision is to decrease duplication of effort when activities are 
comparable; requiring a state that utilizes nonduplication to conduct 
additional compliance review work as compared to a state that conducts 
the EQR-related activity appears to undermine the statutory intent. 
Therefore, we decline the commenter's recommendation.
    Comment: One commenter requested clarification regarding the use of 
nonduplication; the proposed rule states it is optional, but it is 
unclear if this will remain optional or become highly recommended or 
required.
    Response: The nonduplication provision is optional for states. 
Under section 1932(c)(2)(B) of the Act, states must be permitted to 
rely information from a Medicare or private accreditation review, but 
whether or not to exercise the option is left to each state.
    Comment: One commenter supported the expansion of nonduplication 
for the validation of performance measures, but expressed concern about 
the use of nonduplication for PIP validation if the PIP does not align 
with a state's approach and selected topics.
    Response: Section 438.358(b)(1)(i) of the final rule requires 
validation of the PIPs required under Sec.  438.330(b)(1). If the 
project(s) validated as a part of the accreditation review do not fully 
align with those required under Sec.  438.330(b)(1), then the 
accreditation review would not be comparable to the EQR-related 
activity finalized at Sec.  438.358(b)(1)(i), and the state would be 
required to ensure the completion of this activity.
    Comment: One commenter expressed concern regarding duplication 
between annual state Medicaid network adequacy assessment and the 
annual EQR-related activity of network adequacy validation for MCOs 
operating in combination with FIDESNPs and D-SNPs and exclusively 
serving dually eligible beneficiaries.
    Response: While the details of the validation of network adequacy 
EQR-related activity will be determined through the EQR protocol 
process, we intend this activity to be distinct from other network 
monitoring activities which may be undertaken by the state. In the 
event that the state's network monitoring activities closely align with 
the EQR protocol for the network adequacy validation activity, we note 
that a state, its agent that is not an MCO, PIHP, or PAHP, or an EQRO 
are all eligible entities to conduct the mandatory EQR-related 
activities.
    Comment: A few commenters sought clarification of the permitted 
time for using accreditation information and the allowable time period 
for collecting PIP and performance measure data.
    Response: Nonduplication is an option for states when the standards 
of the Medicare or private accrediting entity review used to obtain the 
data are comparable to the standards for the EQR-related activity, as 
described in the associated EQR protocol. This comparability would 
apply to timeframes, as well as processes. Therefore, if the only 
information available from a Medicare or accreditation review was 2 or 
more years old, it would not be comparable to the information generated 
by the performance of an annual EQR-related activity.
    Comment: One commenter asked if CMS intends to update the EQR 
protocols to incorporate data from a Medicare or private accrediting 
entity review.
    Response: We do not intend to update the EQR protocols to 
incorporate data from a Medicare or private accrediting entity review. 
The EQR protocols are developed for the EQR-related activities in Sec.  
438.358 independently of Medicare or accreditation review standards. 
For nonduplication to be an option for a state, the Medicare or 
accreditation review standards must be comparable to the EQR protocols, 
not vice versa. States have flexibility to then define within their 
managed care quality strategy which comparable standards are selected 
for nonduplication and the justification for selecting those standards. 
We intend to provide guidance on comparability for the mandatory EQR-
related activities in Sec.  438.358(b)(1) to (b)(3) through future EQR 
protocols required under Sec.  438.352.
    Comment: One commenter requested clarification on the guidelines 
provided in the proposed rule to ensure the alternative review 
mechanism is valid and reliable.
    Response: While CMS is responsible for determining the validity and 
reliability of the Medicare or accreditation review, the standards for 
these reviews are set outside of the Medicaid program. We will issue 
guidance in the EQR protocols to address when such reviews may be 
considered comparable to the EQR-related activity.
    Comment: One commenter agreed with the use of NCQA accredited plans 
that already use HEDIS measures.
    Response: We do not intend to promote or require that states 
contract with NCQA accredited plans that already use HEDIS measures. 
Rather, we used NCQA accredited plans in the proposed rule as an 
example of a situation in which a plan's performance measures may have 
already been validated as a part of the accreditation process. States 
have flexibility to determine which, if any, accreditation to require 
of managed care plans, and maintain flexibility in choosing if 
accreditation information will be used as part of the EQR process.
    After consideration of the public comments we are finalizing this 
section with modification to clarify that nonduplication must operate 
consistent with guidance issued by the Secretary under Sec.  438.352. 
We are also reorganizing this section so that the general rule, 
including qualifying conditions, is finalized as paragraph (a) and 
paragraph (b) contains the requirement that if a state uses information 
from a Medicare or accreditation review to support an EQR-related 
activity, this information must be provided to the EQRO. Paragraph (c) 
is revised to reflect that the state's use of and rationale for 
nonduplication must be included in the managed care quality strategy, 
in light of the withdrawal of the proposed comprehensive quality 
strategy.
(n) Exemption From External Quality Review (Sec.  438.362)
    This section is based on section 1932(c)(2)(C) of the Act, which 
provides that a state may exempt a MCO from undergoing an EQR if the 
MCO has a current Medicare contract under part C of Title XVIII or 
under section 1876 of the Act, and, for at least 2 years, has had in 
effect a Medicaid contract under section 1903(m) of the Act. We 
proposed the removal of PIHPs, as they are not entities that fall under 
section 1903(m) of the Act. We also proposed to update the phrase 
``Medicare+Choice'' to ``Medicare Advantage'' (MA).
    We received the following comments in response to our proposal to 
revise Sec.  438.362.
    Comment: Two commenters agree with allowing a state to exempt a MCO 
from undergoing an EQR if the MCO has a current Medicare contract. One 
commenter also supported the

[[Page 27713]]

requirement that the MCO must have a Medicaid contract in effect for at 
least 2 years, and noted that this requirement is already in place.
    Response: We thank the commenters for their support of these 
provisions, which implement section 1932(c)(2)(C) of the Act.
    Comment: Several commenters supported the proposal to limit 
exemptions to MCOs.
    Response: We appreciate commenters' support; we are finalizing this 
provision such that its application is limited to MCOs as proposed.
    Comment: One commenter disagreed with allowing MCOs to be exempt 
from the EQR process. The commenter notes that EQR has been an asset 
for the state when reviewing MCO policies and procedures, and would 
likely continue to use EQR even if the requirement for it were removed. 
Another commenter requested that CMS not allow more than two 
consecutive exemption periods for a MCO. The commenter notes that this 
recommendation will balance the goal of aligning requirements across MA 
and Medicaid managed care while ensuring that the specific health care 
needs of the Medicaid managed care population are met.
    Response: Section 1932(c)(2)(C) of the Act allows states to deem 
compliance with EQR for certain plans with a Medicare contract under 
section 1876 of the Act or MA (Medicare Part C). Neither the statute 
nor Sec.  438.362 requires states to exempt plans from EQR; this is 
provided only as an option for states. It is up to the state, not a 
managed care plan or CMS, to determine whether or not to exempt a plan 
from EQR. The state has discretion to require all their managed care 
plans to undergo EQR, even those that appear eligible for an exemption 
under this section. Although we did not propose to limit the duration 
of a plan's exemption from EQR, a state may elect to set such a limit. 
We recognize the importance of understanding which plans states have 
exempted from EQR, and for how long the plan has been exempt, and we 
encourage states to post this information on their Web site. We will 
consider proposing in future rulemaking, to require that states do so.
    Comment: One commenter asked CMS to clarify whether a state may 
exempt an MCO from undergoing an EQR if the MCO has a current Medicare 
contract in a different state.
    Response: No, a state may not exempt an MCO from undergoing an EQR 
if the MCO's current Medicare contract is in a different state. Per 
paragraph (a)(2) of this section, one of the criteria that must be 
satisfied for a state to exempt a MCO from EQR is that the MCO's 
current Medicare contract and its current Medicaid contract must cover 
all or part of the same geographic area within the state.
    Comment: One commenter asked CMS to clarify who determines if an 
MCO is performing acceptably with regard to the quality, timeliness, 
and access to health care services the MCO provides to Medicaid 
beneficiaries, and what review standards are used for this 
determination.
    Response: The state determines if a specific MCO is performing 
acceptably, using standards established by the state. Given that the 
EQR examines the quality, timeliness, and access to health care 
services provided by an MCO, the state should examine EQR data to 
determine if the MCO has performed acceptably during the most recent 2 
consecutive years.
    Comment: One commenter opposed the removal of the exemption option 
for PIHPs.
    Response: Section 1932(c)(2)(C) of the Act limits the exemption 
option to Medicaid MCOs that have a current Medicare contract under 
part C of Title XVIII or under section 1876 of the Act and has had a 
contract in effect under section 1903(m) of the Act for at least the 
last 2 years. By its own terms, this language does not apply to PIHP 
contracts, which are not under section 1903(m) of the Act. While we 
could elect to use the authority under section 1902(a)(4) of the Act to 
expand this option to PIHPs (as it did in the 2003 final rule) and 
PAHPs, these delivery systems are unique to Medicaid and do not exist 
under either Medicare Part C or under section 1876; therefore, there is 
not a scenario under which either PIHPs or PAHPs would be eligible for 
an exemption.
    After consideration of the public comments, we are finalizing this 
section with minor wording revisions.
(o) External Quality Review Results (Sec.  438.364)
    This section sets forth the information, or final deliverables, 
that annually result from the EQR. We proposed several changes to this 
regulation to assist CMS and the states in meaningfully assessing the 
performance of each managed care plan. For more discussion, see section 
I.B.6.b.2.o of the June 1, 2015 proposed rule. Previously, the EQR 
activities in Sec.  438.358(b)(1) and (2) only refer to validation of 
the data. While we continue to believe that data validation is 
important and should remain a core function of the EQR process, a 
statement of validation alone is insufficient to provide insight into 
plan performance on quality, timeliness, and access to care. Therefore, 
under Sec.  438.364(a)(1) we proposed that each EQR technical report 
include performance measurement data for any collected performance 
measures and implemented PIPs (in accordance with each EQR activity 
conducted in accordance with Sec.  438.358(b)(1) and (2)).
    In paragraph (a)(3), we proposed the inclusion of recommendations 
for how states can target the goals and objectives in the comprehensive 
quality strategy to better support improvement in the quality, 
timeliness, and access to health care services furnished to Medicaid 
beneficiaries. In paragraph (a)(4), we proposed deleting the language 
that allows the state alone to decide the appropriate methodology of 
comparative information about managed care plans, as we believe this 
should be a determination made by the state in conjunction with CMS 
(via the Protocols, as described in Sec.  438.352).
    In paragraph (b)(1), we proposed that states contract with a 
qualified EQRO to produce the final EQR technical report (that is, we 
clarified that there is no other entity which may produce the EQR 
technical report) and we proposed that this report be completed and 
available for public consumption no later than April 30th of each year. 
We also proposed that states may not substantively revise the content 
of the final EQR technical report without evidence of error or 
omission, or upon requesting an exception from CMS.
    Paragraph (b)(2) proposed that states maintain the most recent copy 
of the EQR technical report on the state's Medicaid Web site, proposed 
under Sec.  438.10(c)(3). We also proposed to separate out the existing 
language for states to make the information available in alternative 
formats for persons with disabilities in a new paragraph (b)(3). As 
part of this proposal, we replace the phrase ``sensory impairments'' 
with ``disabilities''.
    We received the following comments in response to our proposal to 
revise Sec.  438.364.
    Comment: Many commenters generally agreed with the proposed changes 
to this section of the rule.
    Response: We appreciate the support for the proposed revisions and 
note that we are finalizing this section with modifications, as 
described below.
    Comment: A few commenters requested clarification on the April 30th 
technical report production date. One commenter requested the option to 
produce a report 90 days following the end of a contract year, and 
another

[[Page 27714]]

commenter suggested alignment with the HEDIS measure audit and 
reporting timeframes.
    Response: The April 30th deadline will align with the timeframe 
needed for the annual reporting of managed care data by the Secretary 
each September 30th as prescribed by section 401 of the Children's 
Health Insurance Program Reauthorization Act (CHIPRA) of 2009 (Pub. L. 
111-3) and section 2701 of the Affordable Care Act. The EQR technical 
reports must be published on the state's Medicaid Web site by this 
date, annually. We note that this timeframe is consistent with current 
subregulatory guidance, and do not believe this will require 
significant modification of existing state practices. However, states 
are responsible for establishing timeframes in their EQRO contracts 
which allow the states to meet this reporting deadline.
    Comment: A commenter requested that states be required to share a 
draft EQR technical report with the managed care plans prior to 
finalization, and that the EQRO should be required to give 
consideration to plan comments. If the EQRO does not agree to amend the 
report based on managed care plan comments, then the plan comments 
should be included as a mandatory addendum to the report. This would 
align with the procedures used by federal audit agencies such as the 
HHS OIG and the GAO.
    Response: The EQR technical report is a tool to assist state 
oversight of managed care plans. Given this, we believe it is 
appropriate to defer to the states as to if and when to share the draft 
EQR technical report with managed care plans, and preserve this 
flexibility in the final rule. We note that the EQR technical report 
represents the independent analysis of a state's managed care plan(s) 
by a qualified EQRO. Under this final rule, states may not 
substantively revise the content of the final EQR technical report 
without evidence of error or omission. Given this, we do not believe it 
would be appropriate to require EQROs to include comments from managed 
care plans as an addendum to the EQR technical report, and decline this 
recommendation. However, we note that the final rule is sufficiently 
flexible to allow a state to take up the commenter's recommendations if 
it chooses to do so.
    Comment: A commenter recommended that states be allowed to revise 
the final EQR technical reports.
    Response: We believe that states should only revise the final EQR 
technical report when there is evidence of error or omission. 
Information provided to the EQRO in accordance with Sec.  438.350(a)(2) 
is obtained through methods consistent with the protocols established 
under Sec.  438.352. Unless inaccuracies are identified in the reports, 
we believe these reports should not be edited by the state prior to 
publication since they represent an independent assessment of the 
quality, timeliness, and access to care provided by the managed care 
plans. In the case of inaccurate information, states can and should 
work with the EQRO per Sec.  438.364(b) to ensure presentation of 
accurate information prior to publication. We note that the preamble to 
the proposed rule, but not the associated regulation text, said that 
states wishing to make additional revisions to their EQR technical 
reports (other than those due to error or omission) could seek an 
exception from CMS. This statement was inaccurate; we do not intend to 
develop an exception process. Under Sec.  438.364(b) the final rule, 
states may not substantively revise the content of the EQR technical 
report without evidence of error or omission.
    Comment: A few commenters recommended CMS require plans to maintain 
an archive of past EQR technical reports on their Medicaid Web site; 
some recommended this archive contain the reports from at least the 
previous 5 years.
    Response: While we encourage states to maintain an online archive 
of prior year EQR technical reports, in the final rule we are only 
requiring states to post their new EQR technical reports by April 30th 
of each year. We encourage interested parties to view the reports 
annually. We also note that states must keep these reports consistent 
with state record-keeping policies and consistent with Sec.  
431.17(b)(2) and (c).
    Comment: Several commenters recommended that CMS broaden the 
transparency requirements related to EQR technical reports. One 
commenter requested transparency for any information that would be 
useful to stakeholders including, but not limited to quality standards 
and measurements. Another commenter requested more robust reporting of 
quality measures. A few commenters recommended the final rule add a 
requirement that EQR technical reports account for all violations 
identified by the state or EQRO during the compliance review and detail 
corrective actions taken. One commenter recommended CMS should support 
states in complying with this requirement through technical assistance 
and resources.
    Response: We believe that the transparency of information 
provisions related to the quality and delivery of services to 
beneficiaries through a managed care delivery system provided under the 
proposed regulations, and finalized in this rulemaking, provide the 
information which is critical to ensuring plan accountability and 
enabling consumers to make informed decisions about their health care, 
without imposing undue administrative burden on states. Specific to EQR 
results, Sec.  438.364(a)(2)(iii) of the final rule requires that EQR 
technical reports include the validated performance measurement data 
for any performance measures or PIPs finalized under Sec.  
438.358(b)(1)(i) and (ii). Section 438.364(b)(2) of the proposed rule, 
finalized as Sec.  438.364(c)(2)(i), requires that EQR technical 
reports be posted on the state's Web site by April 30th of each year. 
Under the proposed rule, and finalized in this rule-making, the annual 
EQR technical report will include information from the new EQR-related 
activity of network adequacy validations (finalized as Sec.  
438.358(b)(1)(iv)).
    There are additional provisions intended to improve transparency 
outside of the EQR process being finalized with this rulemaking, 
including a requirement that states operate a Web site (Sec.  
438.10(b)(3)) which will include, at a minimum: The enrollee handbook 
(Sec.  438.10(g)); the provider directory (Sec.  438.10(h)); network 
adequacy standards (Sec.  438.68(e)); plan accreditation status (Sec.  
438.332 of the final rule); quality ratings for managed care plans 
(Sec.  438.334); managed care quality strategies (Sec.  438.340); and 
EQR technical reports (Sec.  438.364(c)). We believe that these items 
will ensure that the public has access to a state's quality standards, 
more robust quality measurement data, and information on network 
adequacy.
    Regarding the recommendation that EQR technical reports include 
information concerning violations uncovered during the compliance 
review and any corrective actions taken, we note that in accordance 
with section 1932(c)(2)(A)(iii) of the Act, the Secretary, in 
consultation with the National Governors' Association (NGA), will 
contract with an independent quality review organization to develop and 
revise protocols to guide states and EQROs in conducting EQR. We will 
include a review of public comments to CMS-2350-P, including this 
section, in the next EQR protocol review and revision process, at which 
time we will consider this recommendation. We are therefore finalizing 
this section as proposed, with modifications described below.
    Comment: A commenter recommended that states should retain the sole 
authority to determine the

[[Page 27715]]

methodology for comparative information about plans in the EQR 
technical report (Sec.  438.364(a)(4)) because the commenter believes 
states are in the best position to understand these variations across 
their managed care program and draw any meaningful comparisons between 
plans.
    Response: We agree that states are in the best position to 
understand the variations across their managed care program(s) and have 
discretion in establishing standards for performance beyond the minimum 
standards identified in the final rule. However, to assure a consistent 
approach to comparing plans, CMS, working in conjunction with the NGA 
as prescribed in section 1932(c)(2)(A)(iii) of the Act, will develop 
protocols for the methodology. CMS will assess options for state 
flexibility in comparative reporting during the EQR protocol review and 
revision that will follow this rulemaking. We are revising proposed 
Sec.  438.364(a)(4), redesignated at paragraph (a)(5) in the final 
rule, to reflect that the methodology for plan comparison will be 
included in the EQR protocols developed in accordance with Sec.  
438.352.
    Comment: A commenter stated they are concerned that only requiring 
plans to make the ``findings on access and quality of care'' available 
on request to interested parties, including enrollees/prospective 
enrollees, participating providers, and beneficiary advocacy groups 
does not provide adequate transparency.
    Response: We agree with this commenter that only requiring plans to 
make the findings on access and quality of care available on request 
would be insufficient. However, proposed Sec.  438.364(b) also requires 
states to post the most recent annual EQR technical report(s) on the 
state's Web site no later than April 30th of each year. Additionally, 
individuals can request this information from the state, and the state 
shall make the information available upon request, including in 
alternative formats for persons with disabilities. We are finalizing 
these requirements as Sec.  438.364(c)(2).
    Comment: A commenter opposed the proposed changes to Sec.  438.364, 
believing that they were redundant with state requirements to post the 
state's quality improvement strategy on its Web site, including 
evaluation results for both performance measures and PIPs. In addition, 
the commenter stated stakeholders and consumers are far more likely to 
access the state quality strategy than the technical report.
    Response: The commenter has misinterpreted the proposed rule. While 
the quality strategy and EQR both will be publicly posted online, each 
serve a distinct purpose. The state quality strategy will set forth a 
blueprint for state goals, objectives, and quality measurement 
approaches to improve care delivery and health outcomes for Medicaid 
beneficiaries; the EQR technical report(s) provide analysis and public 
reporting of quality, timeliness, and access to care for contracted 
MCOs, PIHPs, PAHPs, and PCCM entities described in Sec.  438.310(c)(2).
    After consideration of the public comments, we are finalizing this 
section with modification to reflect the application of EQR per Sec.  
438.350 to PCCM entities described in Sec.  438.310(c)(2) and with 
nonsubstantive modification to improve clarity.
(p) Federal Financial Participation (Sec.  438.370)
    This section sets forth the matching rates for expenditures for 
EQR, including the production of EQR results and the conduct of EQR-
related activities when performed by a qualified EQRO or other entity. 
In the proposed rule, we proposed to revise the regulations to reflect 
the fact that the enhanced 75 percent EQR match rate provided for under 
section 1903(a)(3)(C)(ii) of the Act is only authorized for reviews 
conducted under section 1932(c)(2) of the Act. Section 1932(c)(2) of 
the Act provides that each contract under section 1903(m) with a 
Medicaid MCO must provide for EQR conducted by a qualified independent 
entity. PIHPs do not have contracts under section 1903(m) of the Act. 
Thus, the statute does not provide a basis for paying the 75 percent 
match rate for EQR conducted in connection with these entities.
    In the 2003 final rule, we used the authority of section 1902(a)(4) 
of the Act to extend EQR to PIHPs. We determined that, because we were 
extending the performance of EQR under section 1932(c)(2) of the Act to 
PIHPs, such review could be considered to be performed ``under'' 
section 1932(c)(2) of the Act, even though it was not ``required'' by 
section 1932(c)(2) of the Act itself for purposes of qualifying for the 
enhanced federal match rate of 75 percent. In re-examining this issue 
in connection with this rulemaking, we believe that, in context, 
``under section 1932(c)(2),'' as used in section 1903(a)(3)(C)(ii) of 
the Act, means review performed ``under to'' that provision, (that is, 
review required by that provision). Because that provision by its clear 
terms provides for and requires review only for MCOs that contract 
under section 1903(m) of the Act, we proposed in paragraph (a) that 
only EQR or EQR-related activities performed by EQROs for MCOs with 
contracts under section 1903(m) of the Act are eligible for the 75 
percent match.
    In paragraph (b), we proposed clarifying that EQR and EQR-related 
activities performed on entities other than MCOs (including PIHPs, 
PAHPs, primary care case management arrangements, or other types of 
integrated care models) would be eligible for a 50 percent 
administrative match, regardless of what type of entity performs the 
review (that is, the state, its agent that is not an MCO, PIHP, or 
PAHP, or an EQRO).
    Finally, in paragraph (c), we proposed that states submit their 
EQRO contracts to CMS prior to claiming the 75 percent match. Although 
section 1932(c)(2) of the Act does not require review and approval by 
CMS of EQRO contracts, we believe the reason for doing so remains the 
same as it is today--to allow CMS to determine if the EQRO contract 
complies with the EQR-related provisions of this rule (for example, by 
confirming that contracting entities meet the standards set forth in 
Sec.  438.354 for qualified EQROs), and, if so, which activities under 
the contract are eligible for the 75 percent match.
    We received the following comments in response to our proposal to 
revise Sec.  438.370.
    Comment: Several commenters disagreed with CMS' statutory 
interpretation and recommended that CMS continue to allow PIHPs to be 
eligible for the 75 percent FFP match rate. Commenters stated that the 
extension of enhanced FFP match rate for PIHPs has been uncontroversial 
for more than a decade, and that CMS used authority under section 
1902(a)(4) of the Act elsewhere in the proposed regulation to implement 
methods of administration necessary for the proper and efficient 
operation of the plan.
    One commenter stated that what the commenter called our ``narrow 
reading'' of section 1903(a)(3)(C)(ii) of the Act to only include those 
contracts ``required'' by section 1932(c)(2) of the Act, is not 
compelled by the statute, but is ``an arbitrary change of policy.'' The 
commenter stated that EQR of PIHPs could be construed to be provided 
for under section 1932(c)(2) of the Act because this section requires 
each contract ``under section 1903(m)'' with a Medicaid MCO to provide 
for annual external independent review, and while PIHPs do not enter 
into contracts that are subject to the contract requirements in section 
1903(m)(2)(A) of the Act, they likely do meet the broad definition of

[[Page 27716]]

``MCO'' in section 1903(m)(1) of the Act, and their contracts thus 
could be considered to be ``contracts under section 1903(m)'' for 
purposes of review being deemed to be under section 1932(c)(2) of the 
Act, and thus for purposes of the availability of a 75 percent match 
rate under section 1903(a)(3)(C)(ii) of the Act. The commenter went on 
to state that, while PIHPs are not required to comply with the 
requirements in section 1903(m)(2)(A) of the Act that apply to 
comprehensive risk contracts as defined in that section, the commenter 
erroneously believed that PIHPs would be subject to the reporting 
requirements in section 1903(m)(4) of the Act and to the sanctions 
under section 1903(m)(5) of the Act, and they thus in this sense also 
would be contracts ``under section 1903(m).'' The commenter correctly 
noted that CMS, through its regulations, applies all the same EQR 
requirements for PIHPs as for the entities designated as MCOs in its 
regulations but erroneously stated that CMS' authority to apply these 
requirements was derived from the authority provided in section 1903(m) 
and 1932(c)(2) of the Act. The commenter stated that CMS, in the 
commenter's view, lacks authority to not apply those requirements to 
PIHPs that do not meet the statutory definition of an MCO. The 
commenter recommended that CMS clarify that the enhanced matching rate 
for EQR is available to both the entities it designates by regulation 
as MCOs and PIHPs, under the authority specified in sections 
1932(c)(2), 1903(m) and 1903(a)(3)(C)(ii) of the Act.
    Others stated on fairness grounds that all entities subject to EQR, 
including PIHPs, PAHPs and PCCM entities, should be eligible for the 75 
percent FFP match rate. These commenters noted that it appears 
contradictory to expand EQR to PAHPs and PCCM entities while not 
providing the enhanced FFP match rate for EQR review of these entities. 
Two commenters recommended that CMS either apply the 75 percent match 
rate for all entities subject to EQR or eliminate the requirement to 
review PIHPs and the proposed requirement to review PAHPs in the same 
manner. Commenters noted that the implications of this proposed policy 
change would be substantial and stated that an enhanced match rate 
would support States in conducting the variety of new quality 
requirements proposed in this regulation.
    Response: While we believe that EQR review of PIHPs and PAHPs is an 
important part of states' quality oversight and improvement programs, 
after reviewing the comments and the legal rationale, we continue to 
believe that the 75 percent matching rate under section 
1903(a)(3)(C)(ii) of the Act can only reasonably be interpreted to be 
authorized in the case of review of an MCO that has a contract that 
complies with the requirements in section 1903(m)(2)(A) of the Act. 
While it is true that PIHPs would likely technically meet the 
definition of MCO in section 1903(m)(1) of the Act, this does not make 
a PIHP contract a ``contract under'' section 1903(m) of the Act. 
Meeting the definition of MCO is only one of the several requirements 
that applies to a section 1903(m) of the Act contract (see section 
1903(m)(2)(A)(i) of the Act). Contracts with PIHPs are not in any sense 
entered into ``under'' section 1903(m) of the Act, but as noted above, 
and in the preamble to the 2003 rule extending the EQR requirement to 
PIHPs, under regulations implementing authority in section 1902(a)(4) 
of the Act. As noted above, it is also incorrect that PIHPs are subject 
to the requirements in section 1903(m)(4) and (5) of the Act, because 
paragraph (m)(4) applies only to an MCO, which we have always defined 
in regulations as an entity subject to section 1903(m)(2)(A) 
requirements, and paragraph (m)(5) only applies to a contract ``under 
this section'' (that is, subject to the requirements in section 
1903(m)(2)(A) of the Act).
    Comment: Several commenters stated that CMS should provide the 75 
percent match rate for EQR activities of FFS Medicaid, in addition to 
all managed care programs. One commenter noted that this would align 
with other quality requirements in the proposed regulation that 
encompass all Medicaid delivery systems.
    Response: The 75 percent match rates authorized in section 
1903(a)(3)(C)(ii) of the Act applies only to the independent external 
reviews conducted under section 1932(c)(2) of the Act, which does not 
address reviews of FFS delivery systems. Further, we are not requiring 
states to conduct EQRs of FFS delivery systems under the final rule. We 
note that we are not requiring any specific quality assurance or 
improvement activities for FFS under this final rule, as we are 
withdrawing the proposed comprehensive quality strategy (Sec. Sec.  
431.500-431.506 of the proposed rule). Accordingly, costs associated 
with a voluntary EQR of FFS delivery systems will be matched at the 
regular 50 percent administrative match.
    Comment: One commenter requested that CMS clarify which EQR 
activities will be eligible for the matching funds.
    Response: All EQR-related activities described in Sec.  438.358 are 
eligible for the 75 percent match rate provided that they are conducted 
on an MCO by an EQRO which satisfies the requirements of Sec.  438.354. 
The production of the EQR technical report, as described in Sec.  
438.364, for the EQR of MCOs is also eligible for the 75 percent match 
rate described in Sec.  438.370(a). EQR-related activities conducted on 
entities other than MCOs, or by an entity which does not satisfy the 
requirements of Sec.  438.354 are eligible for the 50 percent match 
rate described in Sec.  438.370(b).
    Comment: One commenter requested that CMS clarify the FMAP rate for 
EQR and EQR-related activities performed on PCCM entities.
    Response: The EQR (including EQR-related activities and the 
production of EQR results) of PCCM entities (described in Sec.  
438.310(c)(2)) is eligible for the 50 percent match rate described in 
Sec.  438.370(b).
    Comment: Given the proposed requirement to develop a comprehensive 
quality strategy for all Medicaid beneficiaries, one commenter 
recommended that the same FFP that is provided for EQRO activities 
should be applied to quality management reviews for populations outside 
of managed care.
    Response: Per section 1903(a)(3)(C)(ii) of the Act, only 
independent external reviews conducted under section 1932(c)(2) of the 
Act are eligible for the 75 percent match rate; the quality strategy is 
not a component of the independent EQR. Quality strategy expenditures 
are eligible for the 50 percent administrative match rate.
    Comment: One commenter recommended that prior to finalizing the 
regulations regarding EQR, CMS should solicit input from all states 
regarding this regulatory provision.
    Response: We agree that CMS should solicit input from states 
regarding this statutory provision, and have done so through the 
Federal Register notice and public comment period. The proposed rule 
was published in the Federal Register on June 1, 2015; the public 
comment period closed on July 27, 2015.
    Comment: One commenter noted CMS' proposal that states submit their 
EQRO contracts to CMS prior to claiming the 75 percent match and 
commented that they already do this.
    Response: We understand and appreciate that many states already 
work closely with CMS regarding their EQRO contracts, and submit these 
contracts to CMS for review prior to claiming the 75 percent match 
rate. While the current regulation text does not expressly require CMS 
approval of these contracts, EQRO contracts have

[[Page 27717]]

been subject to CMS review under the authority of the Secretary to 
ensure compliance with the statute, to determine if they satisfy the 
requirements for the 75 percent match rate. This addition of Sec.  
438.370(c) will formalize the EQRO contract review process, in a manner 
consistent with current policy and practice.
    After consideration of the public comments, we are finalizing this 
section without modification. In addition, we are making a technical 
conforming change to Sec.  433.15(b)(10) to cross-reference Sec.  
438.370(a) of this chapter (75 percent) and Sec.  438.370(b) (50 
percent).
c. State Monitoring Standards (Sec.  438.66)
    In the proposed rule, we relied on the authority in section 
1902(a)(4) of the Act to establish methods of administration for the 
proper and effective operation of the state plan to strengthen our 
state monitoring standards at Sec.  438.66, noting that many of these 
practices are already employed by states. We also proposed a minor 
change in the title of this regulation section to clarify that the 
monitoring required here is a state activity.
    In paragraph (a), we proposed that the state have a monitoring 
system for all of its managed care programs, using the term monitoring 
to include oversight responsibilities. In paragraph (b), we proposed 
that the state's monitoring system address, at a minimum, specific 
aspects of the managed care program that include: Administration and 
management; appeal and grievance systems; claims management; enrollee 
materials and customer services; finance, including MLR reporting; 
information systems, including encounter data reporting; marketing; 
medical management, including utilization management; program 
integrity; provider network management; quality improvement; the 
delivery of LTSS; and other items of the contract as appropriate. We 
noted that research has highlighted these program areas as critical for 
state success.
    In Sec.  438.66(c), we proposed that states use data collected from 
its monitoring activities to improve the performance of its managed 
care program. While we expect that many states already take this 
approach, our proposal would set out a baseline standard for all 
managed care programs. We also provided a list of activities for which 
data should be used for performance improvement. This list encompassed 
the areas that we believe are fundamental to every managed care program 
and for which data is readily available. We did not propose an 
exhaustive list in Sec.  438.66(c) of the performance areas about which 
data may be used in improvement efforts to provide flexibility for the 
state to collect and use additional data they find useful and pertinent 
for its program.
    In Sec.  438.66(d), we proposed to establish a new standard for 
states to conduct readiness reviews of MCOs, PIHPs, PAHPs and PCCM 
entities prior to the effective date of new or modified managed care 
programs, although experience has shown that states employ this 
practice today. As proposed in paragraph (d)(1)(i) through (v), 
readiness reviews would have to be conducted: Prior to the start of a 
new managed care program; when a new contractor enters an existing 
program; or, when the state adds new benefits, populations or 
geographic areas to the scope of its contracted managed care plans. We 
proposed in paragraph (d)(2)(i) and (ii) that these readiness reviews 
would have to commence at least 3 months before the state implements 
any of those program changes, so that states ensure that critical MCO 
functions are operational far enough in advance for successful 
implementation. In paragraph (d)(2)(iii), we proposed that the results 
of those readiness reviews would have to be submitted to us to enable 
us to determine if the contract or contract amendment is approved, 
which would permit both CMS and the state to review the findings, 
discuss any possible issues, and arrive at a mutual understanding of 
expectations. In paragraph (d)(3), we proposed that the readiness 
reviews would consist of both a desk review of documents and an on-site 
visit that includes (at a minimum) interviews with staff and leadership 
that manage key operational areas. We did not propose to define the key 
operational areas but noted that we plan to rely on states to 
reasonably identify those areas in light of the areas which are 
identified in proposed paragraph (d)(4). Finally, we proposed in 
paragraph (d)(4) to require four broad areas for inclusion in the 
readiness review and outline subcomponents within each area. The broad 
areas include: (1) Operations and administration; (2) service delivery; 
(3) financial management; and (4) systems management.
    We noted that these standards reflect our current guidance. For 
example, our guidance for MLTSS programs under section 1915(b) waivers 
and section 1115(a) demonstration projects set forth MCO readiness to 
implement LTSS as a key element under adequate planning; likewise under 
Special Terms and Conditions for new or expanding managed care programs 
under these waiver and demonstration authorities, states conduct 
readiness reviews of their contracted managed care plans. Additionally, 
managed care plans participating in the Capitated Financial Alignment 
Demonstration have to undergo an extensive readiness review process 
before the enrollment of dual-eligible beneficiaries will be permitted.
    Finally, to address the fragmented program information we currently 
receive about states' managed care programs and to help improve our 
oversight efforts, we proposed in Sec.  438.66(e) that states provide 
an annual program assessment report to us. In this proposal, states 
would have to submit these to us no later than 150 days after the end 
of the managed care plan's period of performance. We requested comment 
on whether 150 days is enough time after the end of a program year for 
the state to provide the type of information we proposed. In paragraph 
(e)(1), we proposed flexibility for states which already have to 
provide an annual report under section 1115(a) demonstrations to submit 
that report for this purpose if the information in the annual report is 
duplicative of the information specified here.
    In proposed paragraph (e)(2), we identified the areas on which 
information and an assessment would have to be submitted by the state 
in the report. We proposed that the report include information about, 
and assessments of eight specific areas of the managed care program 
detailed in paragraph (e)(2). We took the opportunity to emphasize that 
states providing LTSS through managed care plans would also have to 
include areas specific to MLTSS in this assessment noting these could 
include alignment of payment rates and incentives/penalties with the 
goals of the program, any activities the managed care plans have 
undertaken to further the state's rebalancing efforts, and the 
satisfaction of enrollees with their service planners. In paragraph 
(e)(3), we also proposed that this annual program assessment would have 
to be posted publicly and provided to the Medical Care Advisory 
Committee and, if applicable the LTSS stakeholder group specified in 
Sec.  438.70.
    We received the following comments in response to our proposal to 
revise Sec.  438.66.
    Comment: Many commenters supported the new standards for a state's 
monitoring system at Sec.  438.66(b). Several commenters noted that CMS 
will need to release sub-regulatory guidance following the final rule 
to further assist states with implementing the new areas of state 
monitoring. Several commenters also recommended that CMS provide 
ongoing technical

[[Page 27718]]

assistance to states regarding the new areas for state monitoring to 
ensure the highest level of quality care for enrollees.
    Response: We thank commenters for their support of Sec.  438.66(b). 
We understand commenters' concerns regarding additional CMS guidance 
and will be available to offer states technical assistance regarding 
any of the new areas of state monitoring and performance. After the 
publication of the final rule, we will assess the appropriate areas 
where additional CMS subregulatory guidance may be needed.
    Comment: Many commenters supported the areas of state monitoring 
identified at Sec.  438.66(b)(1) through (14) but recommended 
additional areas. In total, commenters recommended more than 20 new 
areas of monitoring that states should be required to address in the 
monitoring system, such as state monitoring related to specific areas 
of access to care or state monitoring related to specific types of 
care.
    Response: We appreciate the thoroughness of commenters' 
recommendations regarding areas for state monitoring. However, we 
decline to add additional mandatory areas of monitoring for states to 
address in their state's monitoring system. We believe that the current 
list at Sec.  438.66(b)(1) through (14) is comprehensive and includes 
areas related to provider network management and availability and 
accessibility of services. We also believe that the current standard at 
Sec.  438.66(b)(14) is clear that all other provisions of the contract, 
as appropriate, should be included in the state's monitoring system. We 
also note that states will have the ability to expand their monitoring 
systems beyond the current list specified to account for state-specific 
issues. Therefore, we do not believe it is necessary to add new areas 
to the list at Sec.  438.66(b).
    Comment: A few commenters stated that the new requirements at Sec.  
438.66(b) were too burdensome on states and included duplicative 
reporting areas. Commenters recommended that CMS remove Sec.  438.66(b) 
or reduce the number of areas that require state monitoring.
    Response: We disagree with commenters and decline to remove Sec.  
438.66(b) from the regulatory text. We believe that states should have 
robust and comprehensive state monitoring systems that are inclusive of 
the requirements found at Sec.  438.66(b)(1) through (14). The areas 
specified in Sec.  438.66(b) represent the minimum core aspects of a 
managed care program that a state needs to monitor both as the direct 
contractor with the managed care plan and the agency charged with 
administering the Medicaid program.
    Comment: Many commenters recommended that CMS include specific 
requirements at Sec.  438.66(b) for states to monitor provider rates 
and the timeliness and accuracy of paid claims.
    Response: We believe that state monitoring of the timeliness and 
accuracy of paid claims is included at Sec.  438.66(b)(3) related to 
claims management. We decline to add specific state monitoring 
requirements regarding provider rates in this section, as this does not 
fit our general approach at Sec.  438.66(b). We have included the 
adequacy of provider rates in the requirements at Sec.  438.4(b)(3) for 
actuarial soundness.
    Comment: Several commenters recommended that CMS include at Sec.  
438.66(b)(4) specific state monitoring requirements regarding the 
activities of the beneficiary support system described at Sec.  438.71.
    Response: We agree with commenters that we should clarify that the 
activities of the beneficiary support system are included at Sec.  
438.66(b)(4), as we believe that these activities are an extension of 
enrollee customer service. We believe this clarification to the 
regulatory text is important since the beneficiary support system at 
Sec.  438.71 is a new requirement, and we want to ensure that states 
include its performance in the state's monitoring system. To be 
consistent with the addition at paragraph (b)(4), we will also include 
the performance of the beneficiary support system at Sec.  
438.66(c)(11) to ensure that the state is using the data collected to 
improve the effectiveness and performance of the beneficiary support 
system appropriately. We are modifying the regulatory text to adopt 
this recommendation accordingly.
    Comment: Several commenters recommended that CMS include at Sec.  
438.66(b)(10) specific state monitoring requirements regarding the 
provider directories described at Sec.  438.10(h).
    Response: We agree with commenters that we should clarify that 
provider directories are included at Sec.  438.66(b)(10), as we believe 
that provider directories are an extension of provider network 
management. We believe this clarification to the regulatory text is 
important since the provider directory requirements at Sec.  438.10(h) 
are new, and we want to ensure that states include these new 
requirements in the state's monitoring system. We are modifying the 
regulatory text to adopt this recommendation.
    Comment: Many commenters recommended that CMS include at Sec.  
438.66(b)(11) specific state monitoring requirements regarding the 
network adequacy standards described at Sec.  438.68. Several 
commenters also recommended that CMS include specific references to 
Sec.  438.206 and Sec.  438.207 regarding availability and 
accessibility.
    Response: We agree with commenters that Sec.  438.66(b)(11) should 
be clarified by adding network adequacy standards, as we believe these 
standards are an extension of the availability and accessibility 
requirements already listed. We believe this clarification to the 
regulatory text is important since the network adequacy standards at 
Sec.  438.68 are new, and we want to ensure that states include these 
new standards in the state's monitoring system. We are modifying the 
regulatory text to adopt this recommendation. However, we decline to 
include specific references to Sec. Sec.  438.206 and 438.207, as such 
references are unnecessary and not consistent with the format of this 
section. We believe it is clear that the requirement to monitor the 
availability and accessibility of services is inclusive of the 
requirements at Sec. Sec.  438.206 and 438.207.
    Comment: Several commenters recommended that CMS include more 
specificity at Sec.  438.66(b)(13) regarding LTSS programs.
    Response: We disagree with commenters that additional specificity 
is needed at Sec.  438.66(b)(13) regarding LTSS programs. We have 
provided a comprehensive mandatory list of state monitoring areas at 
paragraphs (b)(1) through (12), that we believe apply to both LTSS and 
non-LTSS programs. We give states the flexibility to include additional 
areas of state monitoring specific to LTSS programs at paragraph 
(b)(13), as appropriate. We believe this flexibility should be retained 
to accommodate the varying scopes of LTSS programs and populations 
served.
    Comment: Several commenters recommended that CMS include specific 
requirements for states to provide quarterly updates to provider, 
consumer, or other stakeholder groups. Several commenters recommended 
that CMS include requirements for states to involve their Medical Care 
Advisory Committee or the LTSS stakeholder group described at Sec.  
438.70 in their state monitoring systems. Other commenters recommended 
that CMS require states to post public notice regarding their state 
monitoring systems. Commenters also recommended that CMS include a 
public comment period for state monitoring systems.
    Response: We require states to deliver their managed care program 
assessment

[[Page 27719]]

reports to both the Medical Care Advisory Committee and the LTSS 
stakeholder group at Sec.  438.66(e)(3)(ii) and (iii). We believe this 
meets commenters' recommendations to involve such groups in the state 
monitoring process. We decline to add requirements that states update 
these groups on a quarterly basis, as we find this recommendation to be 
too prescriptive. While we encourage states to include and update such 
stakeholder groups as often as feasible, this standard should 
ultimately be left to state discretion. We also decline to add specific 
public notice and public comment requirements, as it is unclear to us 
why this would be beneficial. States are required to monitor all 
provisions of their contracts, as appropriate. These state monitoring 
requirements do not require specific public notice or public comment 
periods, as the final report described at Sec.  438.66(e) will be 
public and posted on the state Medicaid Web site, as specified at Sec.  
438.66(e)(3)(i).
    Comment: One commenter recommended that CMS include a specific 
requirement for states to maintain a minimum ratio of state staff to 
enrollees to strengthen contract oversight and state monitoring.
    Response: We disagree with the commenter and decline to adopt a 
requirement for states to maintain a minimum ratio of state staff to 
enrollees. We find this recommendation to be overly prescriptive, as 
states need the flexibility to monitor their programs in the most 
efficient and effective manner. States must weigh a variety of internal 
and operational considerations when determining the appropriate number 
of state staff dedicated to state monitoring and contract oversight.
    Comment: Several commenters recommended that CMS add specific 
standards under each state monitoring area to ensure that states are 
implementing meaningful and effective state monitoring systems. One 
commenter recommended that CMS add more specificity regarding PCCM 
entity requirements, as PCCM entities do not perform activities related 
to all of the areas listed at Sec.  438.66(b).
    Response: We disagree with commenters and decline to add specific 
standards under each state monitoring area listed in paragraph (b), as 
we believe this would be overly prescriptive and not appropriate. While 
we believe in requiring states to implement and maintain a state 
monitoring system, states should retain the flexibility to determine 
the specific performance standards that are most meaningful and 
appropriate for their respective programs. We also decline to add 
specificity regarding PCCM entities, as we included the appropriate 
regulatory text at Sec.  438.66(b) to specify that state systems must 
address all aspects of the managed care program, including the 
performance of each PCCM entity (if applicable) in at least the areas 
listed. If PCCM entities do not perform activities related to all of 
the areas listed, we would not expect the state to include such areas 
in their managed care state monitoring system.
    Comment: Several commenters recommended that CMS include 
requirements at Sec.  438.66(c) for states to provide the data 
collected from its monitoring activities to the Medical Care Advisory 
Committee and LTSS stakeholder group described at Sec.  438.70 on a 
quarterly basis. A few commenters also recommended that states collect 
data from stakeholder groups to improve performance. A few commenters 
recommended that CMS include requirements to collect data from the 
state DUR board and specific DUR activities. A few commenters also 
recommended that CMS clarify that all data collected from a state's 
monitoring activities should be posted publicly to improve 
transparency.
    Response: We disagree with commenters that CMS should include 
requirements at Sec.  438.66(c) for states to provide the data 
collected from state monitoring activities to the Medical Care Advisory 
Committee or the LTSS stakeholder group on a quarterly basis. We 
already require states to deliver their annual managed care program 
assessment reports to both the Medical Care Advisory Committee and the 
LTSS stakeholder group at Sec.  438.66(e)(3)(ii) and (iii). We believe 
this is the appropriate requirement, and states will have the authority 
to provide additional data updates as feasible. We also decline to add 
requirements for states to collect data from stakeholder groups; if the 
state wants to collect qualitative data from such groups, they have the 
option to do so, under state law. In addition, we do not believe we 
need to include requirements for states to collect data from their DUR 
board and DUR activities, as we believe this is already appropriately 
included at Sec.  438.66(b)(8). States have the ability to use DUR data 
as appropriate and meaningful to improve the performance of their 
managed care programs. We also disagree with commenters that all data 
collected should be posted publicly. While we believe in transparency, 
not all data collected would be appropriate for public posting. Instead 
in this final rule, we have required that states post their final 
managed care program assessment report described at Sec.  438.66(e) on 
the state Medicaid Web site for public access, as specified at Sec.  
438.66(e)(3)(i).
    Comment: One commenter recommended that CMS remove Sec.  
438.66(c)(2) and (3) regarding member grievance and appeal logs and 
provider complaint and appeal logs, as it is not appropriate for 
managed care plans to provide these logs to the state. The commenter 
recommended that CMS include summary data instead.
    Response: We disagree with the commenter that member grievance and 
appeal logs and provider complaint and appeal logs should be withheld 
from the state. We believe that states should require these logs as 
part of their state monitoring system. We do not believe that summary 
data is a sufficient substitute for the actual logs, as there may be 
additional details available to the state in the logs that is not 
present in the summary data to support sufficient oversight of the 
managed care plans. We further believe that member grievance and appeal 
logs and provider complaint and appeal logs can provide states with 
valuable information about potential problems that would warrant 
additional investigation. We are aware that many states use the various 
logs to identify potential problems with network adequacy, timely 
access to care, gaps in care coordination, and ineffective utilization 
management. The other advantage of these logs is that they serve as a 
real-time feedback system for monitoring program activity. We encourage 
states and managed care plans to collaborate in making the member 
grievance and appeal logs and provider complaint and appeal logs as 
useful as possible for early identification of potential problems, 
including ensuring that data collected is structured to facilitate 
review and analysis.
    Comment: Several commenters recommended additional requirements for 
CMS to include that would require states to use data collected from 
monitoring activities at Sec.  438.66(c), including provider 
satisfaction surveys, direct testing of network adequacy standards, 
assessments related to care experience, and specific LTSS outcomes, 
such as quality of life indicators.
    Response: We appreciate commenters' recommendations at Sec.  
438.66(c). We agree with commenters that provider satisfaction surveys 
could be included and are modifying the regulatory text to add ``or 
provider'' after ``enrollee'' at Sec.  438.66(c)(5) so that states use 
data collected from the results of any enrollee or provider 
satisfaction survey.

[[Page 27720]]

While we decline to include direct testing of network adequacy 
standards in Sec.  438.66(c), we note that we are finalizing the 
mandatory EQR-related activity of network adequacy validation at Sec.  
438.358(b)(1)(iv) of this rule. While the specifics of this activity 
will be identified in a new EQR protocol, this activity will provide 
additional review of a state's network adequacy standards. States have 
the flexibility to conduct direct testing or other appropriate methods 
to monitor network adequacy. To the extent that states are assessing 
network adequacy and availability of care using direct testing methods, 
we anticipate that the results of such testing would be included in the 
annual report, which addresses the availability and accessibility of 
covered services. We believe that assessments related to care 
experience is adequately included at Sec.  438.66(c)(5) regarding 
enrollee satisfaction surveys. We also decline to add specific LTSS 
outcomes, such as quality of life indicators, as we believe this should 
be left to state discretion depending on the scope of the LTSS program 
and the populations served.
    Comment: Many commenters raised concerns and points in opposition 
to proposed Sec.  438.66(d)(1) related to the requirement for states to 
assess the readiness of each managed care plan and recommended that CMS 
make appropriate revisions to reduce uncertainty, excessive state 
burden, and excessive costs. Specifically, many commenters found the 
criteria listed at paragraphs (d)(1)(i) through (v) to be excessively 
burdensome on states and recommended that CMS consider the scope of 
changes in a managed care program before requiring a comprehensive 
readiness review. Many commenters stated that minor and frequent 
program changes are common, such as minor eligibility or benefits 
changes, and recommended that CMS revise the readiness review 
requirements to accommodate such minor program changes. Several 
commenters also recommended that CMS remove the new geographic 
requirement at paragraph (d)(1)(v), as it is also common for managed 
care plans to add a county to their service area, and such a change 
should not trigger a comprehensive readiness review. In addition, many 
commenters recommended that states be allowed the flexibility to 
determine the frequency of the readiness review, the events that would 
trigger a readiness review, and the exact timing of such readiness 
reviews.
    Several commenters also suggested that CMS remove these 
requirements entirely, as states should determine the best approach 
regarding readiness reviews without federal intervention. Several 
commenters recommended that CMS allow an exemption for mature managed 
care programs and only enforce paragraph (d)(1) on new managed care 
programs. A few commenters recommended that CMS phase in the readiness 
review requirements to ensure states have the budget and staff to 
accommodate the new federal standards. Finally, a few commenters 
supported paragraph (d)(1) as proposed and stated that such standards 
would prevent states from fast tracking the implementation of managed 
care programs without ensuring a comprehensive review process.
    Response: We appreciate the commenters' concerns and 
recommendations and agree that CMS should reconsider Sec.  438.66(d)(1) 
as currently proposed. While we disagree with commenters that we should 
remove paragraph (d)(1) in its entirety, we agree that paragraph 
(d)(1)(iv) and (v) should be removed from the regulatory text to reduce 
burden and allow state flexibility to consider whether the addition of 
new benefits or the expansion of coverage to new geographic areas 
should trigger a comprehensive readiness review. We agree with 
commenters that such program changes may be minor or infrequent and 
that states are in the best position to determine the impact and scope 
of such changes. We are modifying the regulatory text to adopt these 
recommendations.
    However, we believe that paragraphs (d)(1)(i) through (iii) should 
be finalized as proposed, as we believe it is necessary for states to 
assess the readiness of each managed care plan when the state is 
implementing a new managed care program, when the managed care plan has 
not previously contracted with the state, or when the managed care plan 
will be providing or arranging for the provision of covered benefits to 
new eligibility groups. We believe that all three of these scenarios 
represent major changes to a state's Medicaid program and believe that 
states should assess the readiness of each managed care plan 
accordingly. We clarify here that new eligibility groups does not 
include minor changes in program eligibility as a result of ongoing 
program maintenance. The intent of paragraph (d)(1)(iii) is to trigger 
a comprehensive readiness review when a new and distinct eligibility 
group is being added to the managed care plan. We decline to adopt 
commenters' recommendation to add an exemption from paragraph (d)(1) 
for mature managed care programs, as we do not believe that such an 
exemption would be appropriate given the removal of paragraphs 
(d)(1)(iv) and (v).
    Comment: Many commenters recommended revisions at Sec.  
438.66(d)(2)(i) regarding the timeframe for the readiness review to be 
conducted at least 3 months prior to the implementation date. Several 
commenters recommended that CMS allow state flexibility on the 
appropriate amount of time needed to complete a readiness review prior 
to the change described at paragraph (d)(1). Another commenter 
recommended that CMS revise the 3-month requirement to 15 working days. 
One commenter recommended that CMS revise the 3-month requirement to 3 
weeks. A few other commenters recommended that CMS revise the 3-month 
requirement to 180 calendar days. Several other commenters recommended 
that CMS clarify whether the readiness review has to be completed or 
started 3 months prior to the change described at paragraph (d)(1). One 
commenter recommended that CMS establish an exceptions process for the 
3-month timeframe when extenuating circumstances occur, such as the 
withdrawal of a managed care plan.
    Response: We appreciate the opportunity to clarify the requirement 
at Sec.  438.66(d)(2)(i). We clarify that the state must start the 
readiness review at least 3 months prior to the effective date of the 
event described at paragraph (d)(1). However, there is no requirement 
that the readiness review be completed 3 months prior to the event 
described at paragraph (d)(1). We encourage states to complete the 
readiness review as soon as feasible but recognize the challenge of 
completing all elements of the readiness review, especially onsite 
reviews. States must ensure that the readiness review is completed in 
sufficient time to resolve or mitigate problems identified through the 
readiness review to ensure smooth implementation as described at 
paragraph (d)(2)(ii). We decline all commenters' recommendations to 
either lengthen or shorten the 3-month timeframe, as we believe it is 
the appropriate amount of time for states to begin their readiness 
review activities. While we decline to add an exceptions process for 
extenuating circumstances, we are available to provide technical 
assistance and intend to work closely with states when such 
circumstances occur, such as the withdrawal of a managed care plan.
    Comment: Many commenters disagreed with Sec.  438.66(d)(2)(iii) 
regarding the readiness review submission to CMS for CMS to make a

[[Page 27721]]

determination regarding the contract or contract amendment approval 
under Sec.  438.3. Commenters recommended that CMS remove the readiness 
review contingency for contract approval, as many commenters stated 
concerns regarding CMS delays and CMS capacity to review and approve 
such readiness reviews. One commenter recommended that CMS specify the 
exact readiness review documentation needed by CMS to approve the 
contract. Several commenters recommended that CMS add timeframes 
regarding CMS approval. Specifically, several commenters recommended 
that CMS approve such readiness reviews within 30 calendar days of 
receipt. One commenter recommended that CMS revise the reference from 
Sec.  438.3 to Sec.  438.3(a) to add more specificity.
    Response: We appreciate the thoroughness of commenters' 
recommendations but decline to revise the requirements at Sec.  
438.66(d)(2)(iii). While we understand commenters' concerns regarding 
the timing of contract approval, we believe that the CMS review of 
state readiness review documentation will assist us with approving the 
contract or contract amendment. We decline to specify the exact 
readiness review documentation needed, as this could vary greatly 
depending on the event described at Sec.  438.66(d)(1). We also decline 
to add timeframe requirements for CMS review and approval of state 
readiness review documentation. The readiness of managed care plans to 
meet the assurances required under the contract and federal regulations 
are an integral source of information to support approval of the 
contract. The provisions at Sec.  438.66(d)(2)(i) through (iii) require 
the state to start this process in a sufficient amount of time for the 
state to have sufficient assurances from the plan, and thereby, provide 
sufficient assurances to CMS that the contractors are able to meet 
their obligations under the contract. Finally, we agree with the 
commenter that we should revise the reference from Sec.  438.3 to Sec.  
438.3(a) to add more specificity regarding contract approval. We are 
modifying the regulatory text to adopt this recommendation.
    Comment: Several commenters recommended that CMS revise Sec.  
438.66(d)(3) to add more specificity regarding onsite reviews. Several 
commenters recommended that CMS require states to interview advocacy 
groups, stakeholder groups, and consumers when conducting onsite 
reviews. A few commenters recommended that onsite reviews be made 
optional to reduce administrative burden on both states and managed 
care plans.
    Response: We disagree with commenters that we should add a 
requirement at Sec.  438.66(d)(3) to require states to interview 
advocacy groups, stakeholder groups, and consumers when conducting 
onsite reviews. It is not entirely clear to us what value this would 
add regarding the readiness of managed care plans. While we encourage 
both states and managed care plans to work with and involve advocacy 
groups, stakeholder groups, and consumers when designing and 
implementing their managed care programs, we do not believe that we 
should add a requirement for states to interview such groups as part of 
the onsite readiness review. We have reevaluated the requirement for 
onsite reviews and have determined that onsite reviews for events 
described at paragraph (d)(1)(iii), regarding new eligibility groups, 
should be optional and at the state's discretion. However, we believe 
that onsite reviews should remain a requirement for events described at 
paragraphs (d)(1)(i) and (ii), when the state is implementing a new 
managed care program or when the managed care plan has not previously 
contracted with the state. We are modifying the regulatory text to 
adopt this recommendation.
    Comment: Many commenters recommended that CMS allow states complete 
discretion at Sec.  438.66(d)(4) to decide which criteria a state's 
readiness review should include, or states should only be required to 
include the criteria that are directly impacted by the change described 
at paragraphs (d)(1). A few commenters recommended that CMS include 
requirements for states to review the operations of the managed care 
plan's DUR board and the member advisory committee. One commenter also 
recommended that CMS include requirements for states to review the 
managed care plan's claims processing system.
    Response: We appreciate commenters' recommendations but disagree 
that Sec.  438.66(d)(4) should be left only to state discretion. While 
we believe that states will have the expertise to appropriately review 
each area specified at Sec.  438.66(d)(4), we believe it is necessary 
for states to review, at a minimum, the areas specified to ensure the 
managed care plan is adequately prepared to meet the requirements and 
obligations specified in the contract. If a managed care plan is unable 
to perform any of the activities described in Sec.  438.66(d)(4), there 
is a high likelihood that beneficiaries will not be able to receive the 
benefits and services to which they are entitled. Ensuring that managed 
care plans are capable of meeting their obligations under the contract 
is not only good contract management; it is an essential component of 
protecting beneficiaries. We also decline to add specific requirements 
for states to review the operations of the managed care plan's DUR 
board and member advisory committee, as we believe such requirements 
are included at paragraph (d)(4)(i) for the member advisory committee 
and paragraph (d)(4)(ii) for the DUR board. Finally, we note that the 
review of a managed care plan's claims processing system is included at 
paragraph (d)(4)(iv).
    Comment: A few commenters recommended that CMS include requirements 
at Sec.  438.66(d) to include specific readiness review areas for LTSS 
programs, including state LTSS experience, alignment of rates and goals 
for the program, rebalancing efforts, and satisfaction of enrollees.
    Response: We have included specific state monitoring requirements 
for LTSS programs at Sec.  438.66(b)(13) and (c)(12). However, we do 
not believe it is necessary to include specific LTSS readiness review 
areas, as the current requirements specified at Sec.  438.66(d) would 
apply to both LTSS and non-LTSS managed care programs. Many of the 
examples listed by commenters would be appropriately assessed at 
paragraphs (d)(4)(i) and (ii) regarding the operations, administration, 
and service delivery areas of the readiness review. We believe that 
states can appropriately tailor readiness review requirements at Sec.  
438.66(d) for managed LTSS programs and populations, as needed.
    Comment: Many commenters opposed the requirement at Sec.  
438.66(e)(1) for states to submit a report on each managed care plan 
150 days after each contract year. Several commenters recommended that 
CMS eliminate the report at paragraph (e)(1) in its entirety. 
Commenters stated that the report is duplicative of other CMS required 
reporting and would be very burdensome on states to prepare. One 
commenter recommended that CMS allow dashboard reporting instead of the 
annual report. Many commenters stated that 150 days was not enough time 
to prepare each report and recommended that CMS allow more time. 
Commenters recommended 180 days and 8 months as alternative timeframes. 
A few commenters recommended that CMS shorten the timeframe. Commenters 
recommended 30 days, 90 days, and 120 days as alternative proposals. 
Finally, one commenter recommended that CMS

[[Page 27722]]

reconsider the proposal for the reports to be an annual requirement and 
instead recommended that each report be completed once every 5 years.
    Response: We disagree with commenters that we should eliminate the 
report at Sec.  438.66(e)(1) in its entirety, as we believe the report 
will provide valuable and timely information on and an assessment of 
the operation of the managed care program in each state. We also 
believe that the annual report will improve transparency for consumers, 
providers, and other stakeholders interested in the operations of the 
managed care program. The contracts with managed care plans under the 
managed care program are some of the largest (financially) and most 
complex relationships for a state. We believe that the level of 
oversight required under this annual report is consistent with 
expectations for a business relationship of this scope and complexity. 
We note, as specified at final paragraph (e)(1)(ii) (proposed at 
paragraph (e)(1)), that annual reports submitted under the authority of 
section 1115(a) of the Act will be deemed to satisfy the annual report 
requirement. We also decline to allow dashboard reporting instead of an 
annual report, as it is unclear to us what dashboard reporting 
includes. To provide a consistent format across all programs, we 
believe the annual report is an appropriate requirement. To respond to 
commenters concerned about the amount of state burden to prepare and 
develop this report and to better clarify the timing of the 
requirements under this paragraph, we are finalizing regulatory text at 
paragraph (e)(1)(i) to include language that specifies that the initial 
report will be due after the contract year following the release of CMS 
guidance on the content and form of the report.
    We agree with commenters' concerns that 150 days might not be 
enough time to collect the necessary data and produce the report on 
each managed care plan. Therefore, we will adopt commenters' 
recommendation to lengthen the amount of time states have to submit the 
annual managed care program assessment report to CMS from 150 days to 
180 calendar days. We believe that by lengthening the amount of time 
states have to prepare each report, states will have access to cleaner, 
more accurate, and more complete data. We are modifying the regulatory 
text to adopt this recommendation. Finally, we decline to revise the 
annual report requirement in favor of a report submitted once every 5 
years. This recommendation is not consistent with our general approach 
to improve state monitoring requirements, nor is it consistent with the 
approach of CMS to generally require an annual report at the end of 
each program or contract year.
    Comment: Many commenters recommended revisions at Sec.  
438.66(e)(2) regarding the areas of the managed care program assessment 
report. Several commenters recommended that CMS shorten the list at 
paragraphs (i) through (ix) to reduce state burden. Several commenters 
recommended that CMS lengthen the list to include all areas listed at 
Sec.  438.66(b) and (c). One commenter specifically recommended that 
CMS remove paragraph (e)(2)(ii) related to including encounter data 
reporting by each managed care plan. The commenter stated that 
paragraph (e)(2)(ii) seemed to violate HIPAA regulations. Other 
commenters recommended that CMS include an assessment of the state's 
network adequacy standards, the beneficiary support system, and 
structures for engagement of consumers, providers, advocates, and other 
stakeholders.
    Response: We disagree with commenters that we should shorten the 
list of areas that states must include in their annual managed care 
program assessment report for each managed care plan at Sec.  
438.66(e)(2). We carefully balanced all areas listed at Sec.  438.66(b) 
and (c) and included what we believe to be the most appropriate and 
meaningful areas to include in an annual report. We also decline to 
remove paragraph (e)(2)(ii) regarding reporting of encounter data, as 
we disagree that this requirement violates any HIPAA regulations. We 
clarify that states must provide information on and an assessment of 
the operation of the managed care program on the areas listed at 
paragraph (e)(2). It is not our intention to require the publication of 
actual encounter data; rather, it is the intent of paragraph (e)(2)(ii) 
that states assess each managed care plan's performance in this area. 
As stated elsewhere, we believe that encounter data are the basis for 
any number of required activities, including rate setting, risk 
adjustment, quality measurement, value-based purchasing, program 
integrity, and policy development. CMS and states have engaged in many 
efforts to improve the quality, timeliness, and use of encounter data. 
This portion of the annual report provides the opportunity to report on 
the status of those evolving efforts.
    We agree with commenters that states should include information on 
and an assessment of the state's beneficiary support system. We believe 
this is important to not only report on the activities of the 
beneficiary support system, but we also believe that including the 
beneficiary support system will enhance and improve performance over 
time. To be consistent with our preamble discussion and regulatory text 
revisions at Sec.  438.66(b)(4) and paragraph (c)(11), we are modifying 
the regulatory text at paragraph (e)(2) to include the beneficiary 
support system. We will designate the beneficiary support system at 
paragraph (e)(2)(ix) and move the current regulatory text at paragraph 
(e)(2)(ix) related to LTSS to paragraph (e)(2)(x).
    Finally, we will clarify the current regulatory text at paragraph 
(e)(2)(vi) and include network adequacy standards, as we agree with 
commenters that network adequacy standards are an extension of the 
availability and accessibility of covered services. We are modifying 
the regulatory text to adopt this recommendation. We decline to add 
specific requirements for states to include structures for engagement 
of consumers, providers, advocates, and other stakeholders, as we find 
this to be a duplicative requirement. We have included requirements 
throughout part 438 to include stakeholder engagement, such as the LTSS 
stakeholder group required at Sec.  438.70, the managed care plan's 
member advisory committee at Sec.  438.110, and the requirement listed 
at Sec.  438.66(e)(3) for states to provide the annual managed care 
program assessment report for each managed care plan to both the 
Medical Care Advisory Committee and the LTSS stakeholder group. We 
believe that structures for engagement of consumers, providers, 
advocates, and other stakeholders are appropriately included throughout 
part 438.
    Comment: Many commenters supported and recommended revisions at 
Sec.  438.66(e)(3). One commenter recommended that CMS remove the 
requirement to post the annual managed care program assessment report 
on the state's Medicaid Web site at Sec.  438.66(e)(3)(i), as the 
information contained in the report would not promote or improve 
enrollee choice and could be misconstrued. Several commenters 
recommended that the annual report be posted for public comment before 
submission to CMS. A few commenters recommended that managed care plans 
be allowed to review the report before being posted on the state's 
Medicaid Web site. Finally, a few commenters recommended that the 
annual report be provided to the Medical Care Advisory Committee at 
paragraph (e)(3)(ii) and the LTSS stakeholder group at paragraph 
(e)(3)(iii)

[[Page 27723]]

before being posted on the state's Medicaid Web site.
    Response: We disagree with the commenter that we should remove the 
requirement at Sec.  438.66(e)(3)(i) to require the state to post the 
annual managed care program assessment report on the state's Medicaid 
Web site. We believe that the annual report should be posted publicly 
to improve transparency and allow enrollees, providers, and other 
stakeholders to assess the information contained in each managed care 
report. We clarify for commenters that the requirements at paragraph 
(e)(3) do not prohibit a state from posting the annual report for 
public comment. We encourage states to work with enrollees, providers, 
and other stakeholders to ensure that the report is meaningful and 
inclusive of stakeholder feedback. We also clarify for commenters that 
the requirements at paragraph (e)(3) do not prohibit a state from 
allowing the managed care plan to review the report before public 
posting. We expect that states and managed care plans will need to work 
together to ensure that each report is accurate and complete. Finally, 
we clarify for commenters that the requirements at paragraph (e)(3) do 
not prescribe the order of events in posting the annual report on the 
state's Medicaid Web site and providing the annual report to the 
Medical Care Advisory Committee and LTSS stakeholder group. We clarify 
here that states may provide the report to stakeholder groups prior to 
posting the report on the state's Medicaid Web site but it is not a 
requirement under this section.
    After consideration of the public comments, we are modifying the 
regulatory text at Sec.  438.66(b)(4) and Sec.  438.66(c)(11) to 
include the activities and performance of the beneficiary support 
system in a state's monitoring system. We are also modifying the 
regulatory text at Sec.  438.66(e)(2) to include the beneficiary 
support system in the state's annual managed care program assessment 
report. We will designate the beneficiary support system at Sec.  
438.66(e)(2)(ix) and move the regulatory text at Sec.  438.66(b)(10) to 
include specific state monitoring requirements regarding provider 
directories. We are also modifying the regulatory text at Sec.  
438.66(b)(11) and Sec.  438.66(e)(2)(vi) to clarify and include 
specific state monitoring requirements regarding network adequacy 
standards and to clarify that network adequacy standards must be 
included in the state's annual managed care program assessment report. 
We are modifying the regulatory text at Sec.  438.66(c)(5) to add ``or 
provider'' after enrollee to clarify that states should use data 
collected from the results of any enrollee or provider satisfaction 
survey.
    We are modifying the regulatory text to remove Sec.  
438.66(d)(1)(iv) and (v) to reduce burden and allow state flexibility 
to consider whether the addition of new benefits or the expansion of 
coverage to new geographic areas should trigger a comprehensive 
readiness review. In addition, we are modifying the regulatory text at 
Sec.  438.66(d)(2)(iii) to revise the reference from Sec.  438.3 to 
Sec.  438.3(a) to add more specificity regarding contract approval. We 
are also modifying the regulatory text at Sec.  438.66(d)(3) to make 
onsite reviews for events described at Sec.  438.66(d)(1)(iii), 
regarding new eligibility groups, optional and at the state's 
discretion. We are also modifying the regulatory text at Sec.  
438.66(d)(1)(iii) to correct a typo and change the word ``provisions'' 
to ``provision.''
    Finally, we are modifying the regulatory text at Sec.  438.66(e)(1) 
to lengthen the amount of time states have to submit the annual managed 
care program assessment report to CMS from 150 days to 180 calendar 
days. We are also finalizing regulatory text at Sec.  438.66(e)(1)(i) 
to include language that specifies that the initial report will be due 
after the contract year following the release of CMS guidance on the 
content and form of the report. We will also finalize at Sec.  
438.66(e)(1)(ii) the regulatory language proposed at paragraph (e)(1) 
that specifies that annual reports submitted under the authority of 
section 1115(a) of the Act will be deemed to satisfy the annual report 
requirement. We are also finalizing a technical correction at paragraph 
(e)(2) for clarification regarding the areas of the program report. We 
are finalizing all other sections as proposed.
d. Information Requirements (Sec.  438.10)
    In the preamble to the proposed rule, we described our concerns 
that current Sec.  438.10 pertaining to information standards is not 
sufficiently clear or direct and does not reflect current technology 
advances that provide access to information more quickly and less 
expensively. For that reason, we proposed to replace the entire 
existing regulation section with a more organized and clear set of 
standards for beneficiary information. Electronic communications are 
becoming typical, and we proposed to explicitly permit both states and 
managed care plans to make beneficiary information available in 
electronic form, subject to certain standards. We noted that electronic 
information needs to be disseminated in a manner compliant with Section 
504 of the Rehabilitation Act. In addition, we indicated that providing 
for electronic information delivery would further our goal of aligning 
Medicaid managed care beneficiary information dissemination practices 
with those of the private insurance market. We also proposed to remove 
the distinctions among MCO, PIHP and PAHP information requirements. We 
proposed that regardless of the scope of the managed care plan's 
benefits, the information that should be provided to potential 
enrollees and enrollees is the same for all types of plans.
    We also proposed to move the current definitions in paragraph (a) 
to Sec.  438.2 because those terms (``potential enrollee'' and 
``enrollee'') are used throughout this part. We noted the differences 
in these definitions: ``potential enrollee'' refers to a beneficiary 
that has been determined eligible for Medicaid but is not yet enrolled 
in a managed care plan, while ``enrollee'' refers to a beneficiary who 
is a member of a specific MCO, PIHP, PAHP, PCCM or PCCM entity. In 
proposed paragraph (a), we revised the definition of ``prevalent'' and 
added a definition of ``readily accessible'' for use in this section. 
The term ``prevalent'' is currently defined in Sec.  438.10(c)(1); we 
proposed to amend the current definition of ``prevalent'' to clarify 
that the non-English languages that are relevant are those spoken by a 
significant number or percentage of potential enrollees and enrollees 
in the state that are LEP, consistent with standards used by the Office 
for Civil Rights in enforcing anti-discrimination provisions related to 
individuals with limited English proficiency.
    We proposed to add a definition of ``readily accessible'' to 
clarify parameters for the provision of electronic information. We 
noted that states, MCOs, PIHP, PAHPs, and PCCM entities should consult 
the latest section 508 guidelines issued by the U.S. Access Board or 
W3C's Web Content Accessibility Guidelines (WCAG) 2.0 AA (see http://www.access-board.gov/sec508/guide/index.htm and http://www.w3.org/TR/WCAG20/ for additional information.)
    In paragraph (b), we clarified that the standards in this section 
apply to all managed care programs regardless of authority because the 
distinctions among managed care programs that operate under the state 
plan and waivers or demonstration projects are immaterial for purposes 
of beneficiary educational materials that are provided in a managed 
care program. We noted that this section incorporates those

[[Page 27724]]

statutory standards of section 1932(a)(5)(B) through (D) of the Act and 
expands upon them to encompass additional information for all 
beneficiaries based on our authority under section 1902(a)(4) of the 
Act to adopt standards and standards that are necessary for the proper 
and efficient operation of the state plan.
    In proposed paragraph (c), we specified basic standards for 
information in managed care programs. Several of the standards (that 
is, paragraphs (c)(1) through (c)(6)) were proposed to be applicable to 
the state as part of its responsibility for ensuring delivery of 
critical program information to beneficiaries. Paragraphs (c)(1), 
(c)(6) and (c)(7) were proposed to apply to MCOs, PIHPs, PAHPs, and 
PCCM entities; however, PCCMs would need to comply only with paragraph 
(c)(1).
    In paragraph (c)(1), we proposed the fundamental standard that each 
state, enrollment broker, MCO, PIHP, PAHP, PCCM and PCCM entity provide 
all information in an easily understood and readily accessible manner 
and format. Such manner and formats include the use of TTY/TDY and 
American Sign Language interpreters. The proposed regulation is similar 
to the current regulation at Sec.  438.10(b)(1) but would also include 
PCCM entities consistent with the provisions discussed in section 
I.B.6.e. of this final rule. Except for PIHPs and PAHPs, this language 
implemented the statutory provision in section 1932(a)(5)(A) of the Act 
for all enrollment, informational and instructional materials. We 
relied on section 1902(a)(4) of the Act authority to extend such 
standards on PIHPs, PAHPs, and PCCMs for the proper and efficient 
operation of the State plan to ensure that enrollees and potential 
enrollees receive information in a form and manner that they can 
understand. In paragraph (c)(2), we proposed that states must use the 
beneficiary support system proposed under Sec.  438.71 to provide 
education and choice counseling to all beneficiaries. We proposed in 
paragraph (c)(3) that states would need to operate a Web site for 
information about the state's managed care program and could link to 
the Web sites of managed care plans for some of the information. We 
noted that all states already operate a Web site and that this proposal 
would merely codify existing practices. In paragraph (c)(4), states 
would be required to develop standardized managed care definitions and 
terminology, and model enrollee handbooks and notices for use by its 
contracted managed care plans. The suggested list of definitions and 
terminology had been adapted from the standards for a uniform glossary 
that private market insurers must include as part of their summary of 
benefits and coverage (SBC) in 45 CFR part 147. We proposed in 
paragraph (c)(5), that states would need to ensure, through their 
managed care contracts, that MCOs, PIHPs, PAHPs, and PCCM entities 
provide the information outlined in this section.
    In proposed paragraph (c)(6), we identified the standards for 
providing information electronically. Specifically, electronic 
information would have to be compliant with language, formatting, and 
accessibility standards; be in a prominent place on the state's, MCO's, 
PIHP's, PAHP's, or PCCM entity's Web site; and be able to be retained 
and printed. Additionally, all information would be made available to 
enrollees and potential enrollees in paper format upon request at no 
cost and provided within 5 calendar days. We noted that these standards 
are consistent with those for QHPs operating in the Marketplace; thus, 
we believed that by finalizing them we further our goal of alignment 
across insurance affordability programs.
    In proposed paragraph (d), we addressed federal standards for the 
language and format used for beneficiary information, and largely 
carries over existing standards from current paragraph (c). However, we 
proposed to add three new standards, which we believed were important 
beneficiary standards and recognize the cultural and linguistic 
diversity of Medicaid beneficiaries. The first two changes, proposed in 
paragraph (d)(2) and (d)(3), would have materials for potential 
enrollees disseminated by the state, as well as enrollee materials 
disseminated by MCOs, PIHPs, PAHPs or PCCM entities, to be available in 
prevalent languages and include taglines in each prevalent non-English 
language and large print explaining the availability of written 
materials in those languages as well as oral interpretation in 
understanding the materials. We also proposed, based on guidance from 
the American Printing House for the Blind, Inc., that large print must 
be no smaller than 18 point font. We also proposed in paragraph (d)(3) 
that written materials must also be made available in alternative 
formats and auxiliary aids and services must be made available upon 
request of the potential enrollee and enrollee at no cost. The third 
change we proposed was in paragraph (d)(3)(i), where we listed the 
`materials' which each MCO, PIHP, PAHP or PCCM entity would have to 
make available in each prevalent non-English language in its service 
area under our proposal. To determine the types of materials to which 
this standard should apply, we consulted guidance provided by HHS 
regarding access to programs and services for persons with LEP. See 
section I.B.6.d of the proposed rule for discussion of this topic. We 
proposed that provider directories, enrollee handbooks, appeal and 
grievance notices and other notices that are critical to obtaining 
services be considered vital documents, and therefore would have to be 
made available in each prevalent non-English language in its service 
area. The current standard for oral interpretation services would 
remain mostly unchanged in paragraphs (d)(4) except for adding a 
clarification that interpretive services include the use of auxiliary 
aids (such as TTY/TDY) and American Sign Language. Currently, under 
paragraphs (b)(5)(i) and (ii), states have to notify enrollees of the 
availability of interpretation and translation services and how to 
access them. We proposed to add a new paragraph (d)(5)(ii) clarifying 
that potential enrollees and enrollees must be also be notified that 
auxiliary aids and services are available upon request and at no cost 
for enrollees with disabilities. This proposed addition would clarify 
that interpretive services are not limited to LEP potential enrollees 
and enrollees. We proposed to redesignate current paragraph (d)(5)(ii) 
as (d)(5)(iii).
    We proposed in paragraph (d)(6) to establish a standard that the 
availability of alternative formats for beneficiary materials must 
include a large print tagline and information on how to request 
auxiliary aids and services, including the provision of materials in 
alternative formats. Auxiliary aids would include but are not limited 
to the use of TTY/TDY and American Sign Language interpreters. We also 
proposed, based on guidance from the American Printing House for the 
Blind, Inc., that large print must be no smaller than 18 point font.
    In paragraph (e), we proposed the information that must be provided 
to potential enrollees. We proposed in paragraph (e)(1) to provide 
flexibility to the states to provide this information in paper or 
electronic format to ease the administrative burden and cost of mailing 
paper materials to potential enrollees. Proposed paragraphs (e)(1)(i) 
and (ii) would maintain current timeframes for the provision of the 
information.
    In paragraphs (e)(2)(i) through (x), we proposed a minimum list of 
topics that the state would need to provide in the information sent to 
potential enrollees including disenrollment rights, basic

[[Page 27725]]

features of managed care, populations excluded from enrollment, service 
area of each manage care plan, covered benefits, provider directory 
information, cost sharing, network adequacy standards, care 
coordination services available, and quality indicators for each MCO, 
PIHP, PAHP, and PCCM entity.
    The next paragraphs of proposed Sec.  438.10 focused exclusively on 
information standards for managed care plan enrollees--that is, once 
they have selected and enrolled in a managed care plan. Paragraph (f) 
proposed general standards for both the state and managed care plans 
regarding enrollee information; paragraph (g) proposed the minimum 
content of enrollee handbooks; and paragraph (h) proposed the minimum 
content of provider directories. The products of the standards proposed 
in these paragraphs would provide enrollees with a substantial and 
valuable source of information on most aspects of how to access care 
and fully utilize the benefits of their managed care enrollment.
    Proposed paragraph (f) set forth basic standards applicable to 
information that must be disclosed to enrollees of MCOs, PIHPs, PAHPs, 
and PCCMs. In proposed Sec.  438.10(f)(1), we proposed to redesignate 
an existing regulatory standard in current Sec.  438.10(f)(5); that 
standard is that the managed care plan must make a good faith effort to 
provide notice of the termination of a contracted (that is, in-network) 
provider to each affected enrollee within 15 days of receipt or 
issuance of the termination notice. For purpose of these standards, an 
affected enrollee is one who received his or her primary care from the 
provider or was seen on a regular basis by the provider. In paragraph 
(f)(2), we proposed to redesignate an existing regulatory standard in 
current Sec.  438.10(f)(1); the state must notify all enrollees of 
their right to disenroll and clearly explain the process for doing so 
and, if enrollment is restricted for 90 days or more, provide this 
notice at least 60 calendar days in advance of each enrollment period. 
We proposed to add ``calendar'' before ``days'' to eliminate potential 
ambiguity. Lastly, in proposed paragraph (f)(3), MCOs, PIHPs, PAHPs, 
and, when appropriate, PCCM entities, would have to provide, upon 
request, copies of any physician incentive plans in place as specified 
in Sec.  438.3(i).
    The regulatory standards proposed in paragraphs (g), (h), and (i) 
address enrollee handbooks, provider directories, and formularies 
because we believe these are foundational tools to help enrollees 
utilize the benefits and services available to them from their managed 
care plan. We declined to propose regulatory standards for other types 
of plan-enrollee communications, recognizing that those decisions are 
best made at the state level based on the maturity and structure of 
each state's managed care program.
    Proposed paragraph (g) outlined minimum content standards for the 
enrollee handbook; we attempted to align with private market insurance 
standards by reflecting similarities to the SBC in both content and 
appearance. In paragraph (g)(1), each MCO, PIHP, PAHP or PCCM entity 
would have to provide an enrollee handbook to each enrollee within a 
reasonable time after receiving the enrollment notice from the state. 
While the information proposed to be included in the handbook (in 
proposed paragraph (g)(2)), which already exists in current Sec.  
438.10), we noted that it is currently not well organized or all in one 
section for easy reference. Proposed paragraph (g)(2) listed all of the 
existing elements in one paragraph for easy reference. Taken together, 
these elements would be referred to as a ``handbook'' consistent with 
how the term is typically used in Medicaid managed care. While some 
minor grammatical revisions have been made for clarity, we noted that 
the elements remained the same as in current regulation. We also 
proposed to correct a reference in Sec.  438.100(b)(2)(iii) to ``Sec.  
438.10(f)(6)(xii),'' which was redesignated as ``Sec.  
438.10(g)(2)(ii)(A) and (B).
    Paragraph (g)(3) proposed to clarify the circumstances under which 
the MCO, PIHP, PAHP, or PCCM entity would be considered to have 
provided the information in paragraph (g)(2). We proposed mail, email 
if enrollee consent was obtained, Web site with paper and electronic 
notification, auxiliary aids and services at no cost (upon request), 
and any other method that can reasonably be expected to result in the 
enrollee receiving the information. We proposed this last method to 
provide flexibility for communication methods not commonly used, such 
as alternative communication devices for persons with disabilities, and 
other technological advances in communication not yet widely available. 
In proposed paragraph (g)(4) we affirmed the current standard that 
enrollees be notified 30 days in advance of any significant change to 
any of the information in paragraph (g). Consistent with other proposed 
revisions throughout Sec.  438.10, we proposed to delete the standard 
that this notice be written and let the provisions of paragraphs (c) 
and (d) control regarding the standards for the use of written and 
electronic communications. Proposed paragraph (h) specified the minimum 
content standards for provider directories. We noted that the content 
and accuracy of provider directories have long been an issue of 
contention between states, managed care plans and stakeholders and that 
the move to electronic provision of this document should improve the 
accuracy of the information. We also noted that even web-based provider 
directories can be out of date quickly without accurate information 
from participating providers to the managed care plans.
    Paragraphs (h)(1)(i) through (viii) proposed all of the elements 
that exist currently in Sec.  438.10(f)(6)(i) but expanded on them in 
four key ways. In addition to name, address, telephone number, and open 
panel status, we proposed to add four additional elements: A provider's 
group/site affiliation; Web site URL (if available); the provider's 
cultural and linguistic capabilities; and the accessibility of the 
provider's office to enrollees with physical disabilities. Paragraphs 
(h)(2)(i) through (v) proposed five provider types that would have to 
be included in the directory, if applicable under the contract: 
Physicians; hospitals; pharmacies; behavioral health; and LTSS. In 
paragraph (h)(3), we proposed that paper provider directories must be 
updated at least monthly and electronic directories within 3 business 
days of receiving updated provider information. Lastly, to align 
managed care with both QHPs and MA, in paragraph (h)(4), we proposed 
that provider directories be made available on the MCO's, PIHP's, 
PAHP's, or if applicable, PCCM entity's Web site. The current rule for 
MA plans (Sec.  422.111(h)) requires such plans to post provider 
directories online. Additionally, in a recent final rule (80 FR 10873), 
HHS finalized a requirement for QHPs in a federally facilitated 
Marketplace to post provider directories in a machine readable format 
specified by the Secretary. Therefore, to improve transparency and 
provide an opportunity for third party aggregating of information, we 
proposed that MCOs, PIHPs, PAHPs, and if applicable, PCCM entities, 
must post provider directories on their Web sites in a machine readable 
file and format specified by the Secretary.
    We also proposed a new paragraph (i), Information for all enrollees 
of MCOs, PIHPs, PAHPs, and PCCM entities--Formulary. This proposed 
paragraph would have MCOs, PIHPs, PAHPs, and PCCM entities provide 
their medication formularies electronically or on paper, if requested. 
Under paragraphs (i)(1) and

[[Page 27726]]

(i)(2), the formulary must display all covered medications, both 
generic and brand name, and have the tier of each medication. We 
proposed this paragraph because understanding how medications are 
covered by the managed care plan is important information for 
enrollees, particularly for those with chronic conditions or on-going 
needs. Additionally, we proposed that formulary drug lists be made 
available on the MCO's, PIHP's, PAHP's, or if applicable, PCCM entity's 
Web site in a machine readable file and format as specified by the 
Secretary for the same reasons discussed in the proposed rule in 
connection with provider directories. Machine readable files with 
formulary drug lists would provide the opportunity for third parties to 
create resources that aggregate information on different plans. We 
noted this would increase transparency by allowing software developers 
to access this information and create innovative and informative tools 
to help enrollees better understand formulary drug lists across 
specific plans.
    We received the following comments in response to our proposal to 
revise Sec.  438.10.
    Comment: We received many comments supporting the reorganization of 
Sec.  438.10. Commenters believed the proposed Information Requirements 
section was easier to use, more comprehensive, and added needed 
consistency on many covered topics. Commenters were particularly 
supportive of the new proposed sections on enrollee handbooks, provider 
directories, and formularies and believed they will provide critically 
needed information for potential enrollees and enrollees.
    Response: We appreciate the supportive comments and will finalize 
Sec.  438.10 with the organizational structure proposed.
    Comment: We received a few comments requesting that CMS define LEP 
consistent with the definition by the Office for Civil Rights' Guidance 
to Federal Financial Assistance Recipients Regarding Title VI 
Prohibition Against National Origin Discrimination Affecting Limited 
English Proficient Persons, 68 FR 47311 (Aug. 8, 2003).
    Response: We agree and will add to Sec.  438.10(a) the definition 
for LEP published by HHS Office for Civil Rights to Sec.  438.10(a), in 
the Guidance to Federal Financial Assistance Recipients Regarding Title 
VI Prohibition Against National Origin Discrimination Affecting Limited 
English Proficient Persons, 68 FR 47311, 47313 (Aug. 8, 2003).
    Comment: We received many comments on the proposed definition of 
``prevalent'' in Sec.  438.10(a) for the purpose of determining the 
non-English languages for written materials that require translation. 
Some commenters wanted specific thresholds for states to use when 
determining which non-English languages should be represented when 
translating vital documents. Other commenters did not want CMS to adopt 
specific thresholds as existing guidance (for example, HHS Guidance to 
Federal Financial Assistance Recipients Regarding Title VI Prohibition 
Against National Origin Discrimination Affecting Limited English 
Proficient Persons 68 FR 47311 (Aug. 8, 2003) and Executive Order 
13166, ``Improving Access to Services for Persons with Limited English 
Proficiency'') provides sufficient information on how states can 
determine the most appropriate non-English languages spoken in their 
state. Other commenters believed the proposed definition was confusing 
since there are currently no specific published standards by the Office 
of Civil Rights.
    Response: We agree with commenters that existing guidance provides 
a solid foundation and that the reference to standards by the Office of 
Civil Rights was unclear. That reference is not being finalized and 
this regulation will be interpreted consistently with other regulations 
on similar or the same topic. We believe that states, with their 
experience in setting their own thresholds in this area, are capable of 
applying the regulation standard that is being finalized in a 
reasonable and responsible manner.
    Comment: A few commenters suggested that the proposed definition of 
``readily accessible'' in Sec.  438.10(a) could be improved by 
including W3C's Web Content Accessibility Guidelines (WCAG) 2.0 AA and 
Section 504 of the Rehabilitation Act.
    Response: We agree with the commenters and are finalizing the 
definition of ``readily accessible'' as meaning compliance with modern 
accessibility standards. Examples of such standards include Section 504 
of the Rehabilitation Act and W3C's Web Content Accessibility 
Guidelines (WCAG) 2.0 AA and successor versions. The regulation text, 
by using the phrase ``modern accessibility standards'' is designed to 
flexibly adapt with changes and updates to accessibility.
    Comment: A few commenters suggested we clarify ``easily 
understood'' in Sec.  438.10(c) by including a specific grade reading 
level. The commenters believed that all states should use the same 
grade level for consistency.
    Response: We understand that selecting a grade level is a common 
component of states' methodologies for determining if a document can be 
easily understood by the intended audience. We believe using a specific 
grade level is a reasonable approach but acknowledge that there is 
variation among states as to which level is most appropriate. 
Therefore, we decline to add a specific grade level in the final rule, 
leaving that decision to the state.
    Comment: We received many comments supporting the requirement for 
states to have Web sites dedicated to managed care and the specified 
information to be included. We received a comment suggesting that 
proposed Sec.  438.10(c)(3) be reorganized for more appropriate 
grammatical flow, as well as a suggestion that a reference to proposed 
Sec.  438.66(e) be added to make Sec.  438.10(c)(3) a more complete 
list of items that states must post on their Web site. We also received 
several comments recommending that the Web site proposed in Sec.  
438.10(c)(3) be available to the public and not limited to potential 
enrollees or enrollees only. The commenters believe that the 
information could be very valuable to others such as those assisting 
beneficiaries. Lastly, we received a few comments recommending that we 
add a timeframe by which states must update the information on their 
Web sites to ensure that the sites were maintained in a timely fashion.
    Response: We appreciate the supportive comments; we agree that 
Sec.  438.10(c)(3) could be clearer and that the information required 
in this paragraph is appropriate for public viewing. We are modifying 
Sec.  438.10(c)(3) in the final rule to include a reference to Sec.  
438.10(i) which was erroneously omitted in the proposed rule. We are 
not finalizing the references to Sec. Sec.  438.68(e), 438.364(b)(2), 
and 438.602(g) to remove unnecessary cross references; those 
regulations are clear in imposing the requirement that identified 
information be posted on the Web site required under Sec.  438.10(c). 
We are also not finalizing ``(b)(2)'' in ``Sec.  438.364(b)(2)'' as the 
availability of information requirement will be finalized at Sec.  
438.364(c). Minor revisions have been made to improve grammatical flow. 
As to the suggestion for adding a timeframe, we do not believe one is 
necessary. We believe our intent is clear that we expect states to 
maintain their Web sites as accurately as possible. Given that most, if 
not all, states already maintain Web sites that contain some of the 
required information and will likely utilize links directly to the 
managed care plan rather

[[Page 27727]]

than uploading documents for much of the information, we believe that 
attempting to identify an attainable and reasonable time frame that 
would be applicable for all of the required information would not be 
possible. We believe utilizing links directly to the managed care 
plans' Web site will be the most efficient way to provide access to the 
current version of certain required documents.
    Comment: Several commenters recommended that CMS provide the 
definitions for the terms proposed in Sec.  438.10(c)(4)(i), as well as 
model enrollee handbooks and member notices proposed in paragraph 
(c)(4)(ii). Some commenters suggested included adding ``habilitation 
services and devices,'' ``rehabilitation services and devices,'' 
``orthotics and prosthetics,'' ``behavioral health services,'' 
``continuity of care,'' ``care coordination,'' and ``health risk 
assessment'' to the list in Sec.  438.10(c)(4)(i). Commenters believed 
this would result in consistent practices across the states.
    Response: We appreciate these suggestions and clarify that the list 
of terms in Sec.  438.10(c)(4)(i) is a minimum and states should add 
any additional terms they consider appropriate. We are adding ``and 
devices'' to ``habilitation services'' and ``rehabilitation services'' 
in the final rule for consistency with terminology used for essential 
health benefits. While we understand that having CMS provide standard 
definitions and model handbooks and notices would provide some 
consistency, we believe that there is sufficient variation between 
states' program design, covered benefits, and localized use of 
terminology to warrant leaving this responsibility with the states.
    Comment: One commenter requested that CMS clarify if the model 
handbooks proposed may be customized by the managed care plans. Another 
commenter questioned if the state would provide the model handbook 
translated into the prevalent languages.
    Response: Managed care plans should work with the states in which 
they contract for clarification on the level of customization permitted 
and translation of the model handbook. We do not believe that such 
specificity is necessary in Sec.  438.10.
    Comment: We received many comments recommending that enrollees be 
required to affirmatively elect to receive electronic communications, 
or ``opt-in,'' while other commenters believed enrollees should not 
have to affirmatively elect to receive electronic communications, or 
``opt-out.''
    Response: We understand the commenters' recommendations regarding 
the use of electronic communications. However, we do not believe that 
requiring every enrollee to actively elect to receive electronic 
communications would be feasible or necessary. When an email address is 
provided by the enrollee, we believe it is reasonable for the states 
and/or managed care plans to use it for contacting the enrollee unless 
the enrollee requests not to receive communications at that email 
address. An enrollee's request to receive information on paper and/or 
in a prevalent language should be noted in the enrollee's record so 
that future distribution of information is handled consistent with the 
enrollee's preference.
    Comment: A few commenters suggested that the time frame of 5 
calendar days in Sec.  438.10(c)(6)(v) for providing information 
requested on paper was not feasible due to the steps involved in 
printing on-demand, storing printed materials offsite, and producing 
alternative formats. Suggestions for alternatives ranged from 5 
business days to 10 calendar days.
    Response: We understand the concerns raised by the commenters and 
believe that 5 business days, rather than 5 calendar days, will provide 
sufficient additional time for mailing the materials while still 
fulfilling the beneficiary's request in a timely manner. Therefore, we 
are finalizing Sec.  438.10(c)(6)(v) with a timeframe of 5 business 
days.
    Comment: We received a few comments that suggested that Sec.  
438.10(c)(7) should be revised to reference each MCO, PIHP, PAHP, and 
PCCM entity having a system, rather than a mechanism, to help enrollees 
and potential enrollees understand the requirements and benefits of the 
managed care plan or PCCM entity. They believed the term ``system'' 
more appropriately described the intent of this paragraph.
    Response: We do not agree that ``system'' would be more appropriate 
as it may imply more infrastructure than is intended. We do, however, 
concede that ``a mechanism'' is probably too limiting as managed care 
plans utilize many ways to assist enrollees in understanding the 
requirements and benefits of the plan. Therefore, we will finalize 
Sec.  438.10(c)(7) making mechanism plural.
    Comment: A few commenters suggested that the provision in Sec.  
438.10(d)(2) to ``make available oral and written information in each 
prevalent non-English language'' was unclear due to the requirement in 
paragraph (d)(3)(ii) that stated oral interpretation services must be 
provided for all languages, not just prevalent non-English languages. 
Some commenters also suggested that we add ``competent'' each time oral 
interpretation or written translation is addressed.
    Response: We agree with the commenter that Sec.  438.10(d)(2) could 
be clearer and are modifying Sec.  438.10(d)(2) to add ``in all 
languages'' after oral interpretation; we are also revising paragraph 
(d)(2) to finalize it to require ``oral interpretation'' and ``written 
translation'' be available in the applicable languages so that the 
requirement is clearer. We believe these changes more accurately refer 
to the language assistance available to LEP enrollees. We also 
corrected ``written information'' to ``written translation'' in Sec.  
438.10(d)(5)(i). While we agree that only competent interpreters and 
translators should be utilized, we do not believe it is necessary to 
add it throughout part 438 nor to list specific criteria for 
determining competence. It is implicit in the regulation requirement 
that the provision of oral interpretation and written translation serve 
their purpose; that is only possible if the services are competently 
provided. Incompetent translation or interpretation services will not 
satisfy the regulation requirement. Information is available on 
determining competence of interpreters and translators in the HHS 
Guidance to Federal Financial Assistance Recipients Regarding Title VI 
Prohibition Against National Origin Discrimination Affecting Limited 
English Proficient Persons as well as at www.lep.gov.
    Comment: Commenters were very supportive of the proposed inclusion 
of requiring taglines on written materials. We received many comments 
recommending that the proposed requirement in Sec.  438.10(d)(2) for 
taglines in written materials for potential enrollees to be revised to 
require 15 taglines for consistency with QHP requirements.
    Response: We appreciate the commenters' suggestion to adopt the QHP 
standard of 15 taglines; however, we decline to revise Sec.  438.10 to 
adopt such a requirement. We believe that the experience of states and 
managed care plans in determining the prevalent languages within the 
state, as well as utilization data of interpreter and translation 
services by their enrollees, will result in a determination of the 
appropriate number of taglines. We encourage states and managed care 
plans to assess the language needs in their state and add taglines in 
additional languages beyond the languages

[[Page 27728]]

determined as prevalent. We also believe states and managed care plans 
should collaborate with their state-based exchanges and the QHPs in 
their market to determine if sharing taglines could be an effective 
option. Additionally, to reduce duplication, the requirement for 
including taglines on written materials that are critical to obtaining 
services proposed in paragraph (d)(3)(i) has been added to paragraph 
(d)(3) and we are not designating separate paragraphs as (d)(3)(i) and 
(ii).
    Comment: We received many comments suggesting that we add denial 
and termination notices to the list of written materials in Sec.  
438.10(d)(3) and paragraph (d)(3) must be made available in prevalent 
languages and include taglines. Commenters believed that while there 
are many documents that are important to fully utilize a managed care 
program, denial and termination notices are critical enough to warrant 
being specifically mentioned. One commenter suggested that the list in 
Sec.  438.10(d)(3) and (d)(3)(i) specify each document that should be 
considered critical.
    Response: We agree with the commenters on the importance of denial 
and termination notices and are finalizing Sec.  438.10(d)(3) to 
include denial and termination notices in the list of specifically 
identified documents that are subject to the translation requirements. 
We do not believe that the lists in Sec.  438.10(d)(3) can be made 
exhaustive in regulation as each state and managed care plan produces 
different types of documents, so we emphasize here that each state must 
exercise due diligence in determining which documents are critical to 
obtaining services.
    Comment: We received a few comments recommending that CMS require 
that all materials for potential enrollees and enrollees be consumer 
tested prior to use. The commenters believe this would improve 
comprehension and understanding of the materials.
    Response: We agree that consumer testing is a valuable tool 
available to states and managed care plans and encourage them to 
utilize it. States and managed care plans have extensive experience 
producing written materials for their populations and some already use 
consumer testing on their written materials; therefore, we do not 
believe adding a new provision on this issue is necessary.
    Comment: Some commenters recommended that the notices to potential 
enrollees more clearly explain the opportunity enrollees have to change 
plans during the initial 90 days without cause. Commenters believed 
this information was often not clearly or prominently included in 
notices.
    Response: We agree that the opportunity to disenroll from an 
enrollee's current managed care plan without cause during the initial 
90 days of enrollment is an important right and states need to be 
diligent about including the information in a clear way in appropriate 
notices. Notices should already explain this disenrollment right under 
current Sec.  438.56(f). We take this opportunity to remind states of 
the provisions in Sec.  438.56 and encourage them to review their 
notices to ensure that a full and clear explanation of this right and 
easy to follow instructions for exercising it if the enrollee so 
chooses, are included.
    Comment: We received some comments recommending that the notices to 
potential enrollees more clearly explain the length of the enrollment 
period, since disenrollment rights can be limited to for cause reasons 
during this period. Commenters believed states were not consistently 
explaining the significance of this period to enrollees.
    Response: We agree that enrollees need to understand the length of 
the enrollment period and what opportunities for disenrollment will be 
available to them during that period. To address this, we are modifying 
Sec.  438.10(e)(2)(iii) in the final rule to require that the length of 
the enrollment period and that all disenrollment opportunities be 
described in the informational notices.
    Comment: A few commenters recommended that Sec.  438.10(e)(2)(vi) 
be revised to include the managed care plan's formulary in addition to 
the provider directory. Commenters believe reviewing a managed care 
plan's formulary is an important component of the plan selection 
process and potential enrollees should not have to request this 
information separately.
    Response: We understand the commenters' concern and agree. 
Therefore, we are revising Sec.  438.10(e)(2)(vi) in the final rule to 
include the formulary.
    Comment: We received numerous comments recommending that CMS define 
``regular basis'' as used in Sec.  438.10(f)(1) for notice to enrollees 
of a terminated provider. Some commenters suggested that enrollees who 
had received services from a provider within the last 12 months should 
be notified of the provider's termination from the network. They were 
especially concerned that ``regular basis'' may not capture female 
enrollees that only see an OB/GYN once a year for preventive services.
    Response: We understand the commenters' concern. However, we 
believe that providers frequently notify their patients of changes in 
their network status; we do not believe that an additional level of 
specificity is necessary in this provision. We encourage plans and 
states to consider the frequency of services provided by a particular 
provider in identifying the enrollees who see that provider on a 
regular basis.
    Comment: A few commenters recommended that CMS add a 5 day time 
limit for sending out handbooks as referenced in Sec.  438.10(g)(1). 
Commenters believe the current provision for sending handbooks ``within 
a reasonable time after receiving notice of the beneficiary's 
enrollment'' is too vague.
    Response: We understand the commenters' concern and believe that 
states and managed care plans understand the importance of getting the 
handbook to enrollees in a timely fashion since all parties benefit 
from enrollees having the information they need. There is nothing in 
Sec.  438.10 that prevents a state from imposing a specific timeline on 
their managed care plans. Additionally, we believe with the use of 
electronic communications proposed elsewhere in Sec.  438.10, the 
distribution of information will occur very quickly, oftentimes on the 
same day. We believe the option to specify a timeframe is best left to 
the states and will finalize Sec.  438.10(g)(1) as proposed.
    Comment: We received numerous suggestions for additional types of 
information that could be added to Sec.  438.10(g)(2). Suggestions 
primarily included adding specific benefits and how to access them, 
with one commenter suggesting adding the provisions specific to Indian 
enrollees. A few commenters recommended additional text for Sec.  
438.10(g)(2)(vii) to add clarity about the freedom of choice allowed 
for family planning services and devices.
    Response: We appreciate the suggested topics to enhance Sec.  
438.10(g)(2) but found most of them duplicative of an existing 
provision. Paragraph (g)(2) states that this information must include 
at a minimum. We expect states to comprehensively represent each of the 
required topics plus any others that they believe would enhance an 
enrollee's understanding of how to effectively use the program. To make 
this clear for family planning, we have added that managed care plan 
handbooks must include an explanation that enrollees do

[[Page 27729]]

not need a referral before choosing a family planning provider.
    Comment: Commenters generally supported the proposal to strengthen 
provider directory requirements proposed in Sec.  438.10(h) and agreed 
that provider data needs to be as accurate as possible to be useful. 
Commenters recommended a different timeframe for updates than the 3 
business days from receipt as proposed in Sec.  438.10(h)(3). Many 
commenters explained that information included in the directory is 
obtained from numerous sources and must be validated prior to 
acceptance, thus making the 3 business day time frame impossible. Many 
commenters suggested aligning with Marketplace and MA requirements and 
require monthly updates.
    Additionally, many commenters expressed confusion over the 
provision of paper directories; specifically, whether we were proposing 
in Sec.  438.10(h)(3) that they be sent routinely or only upon request. 
Commenters also explained that using the same data source file for the 
electronic and paper directories would be more efficient but would 
require the same updating timeframe for electronic and paper formats. 
One commenter proposed that printing on demand from the on-line 
directory be deemed acceptable.
    Response: We appreciate the information provided by the commenters 
and agree that consistency with guidance applicable to QHPs and MA 
would be the most prudent approach. While this extends the timeframe 
originally proposed for electronic directories, we believe supporting 
accuracy is more productive than retaining an unrealistic timeframe. We 
encourage managed care plans to work to shorten the monthly timeframe 
while maintaining their directories as accurately as possible.
    Regarding questions about paper directories, we clarify that paper 
directories need only be provided upon request and that we encourage 
plans to find efficient ways to provide accurate directories within the 
required time frames. We encourage innovative methods such as single 
data source files or printing the on-line directory to provide accurate 
paper directories within the required timeframe to enrollees that 
request them. To adopt these revisions and clarifications, we will be 
finalizing Sec.  438.10(h)(3) to reflect that paper directories are 
only upon request and that paper directories must be updated monthly 
and electronic provider directories must be updated within 30 calendar 
days after the receipt of updated provider information.
    Comment: Several commenters suggested additional information for 
inclusion in the list of information in the provider directory proposed 
in Sec.  438.10(h)(1). Suggestions included provider gender; 
subspecialties/areas of practice; hospital privileges; age limitations; 
hours of operation; expected period of open or closed panel status; 
utilization management criteria; and provider-tiering and associated 
cost sharing differentials. Commenters believed this information would 
make the directory more comprehensive and useful.
    Response: We appreciate these suggestions and believe many of them 
could provide useful information. We consider the list proposed in 
Sec.  438.10(h) a minimum and encourage states and plans to consider 
the suggested additions and include them as appropriate and feasible.
    Comment: We received several comments on the proposed provision in 
Sec.  438.10(h)(1)(viii) requiring information on the accessibility of 
provider offices for people with physical disabilities. Some commenters 
wanted the proposed requirement expanded to include more information, 
other commenters wanted the proposed requirement narrowed to include 
less information about internal accessibility, and some believed the 
state should be required to obtain the information either through 
licensing or the screening requirement proposed in Sec.  438.602. Many 
commenters clarified that information about internal office 
accommodations is not collected on most credentialing applications nor 
via any other uniform mechanism. Commenters also expressed concerns 
about legal liability issues around reporting an office's accessibility 
features.
    Response: We understand the various commenters' concerns about the 
challenges of collecting this information but continue to believe that 
providing accessibility information is critical, particularly as the 
number of managed LTSS programs increases. To provide more flexibility 
for how the information is displayed in the directory, we have revised 
Sec.  438.10(h)(1)(viii) from ``is accessible'' to ``has 
accommodations.'' We believe this is broad enough for states to 
consider all of the possible accommodations including wide entries, 
wheelchair access, accessible exam tables and rooms, lifts, scales, 
bathrooms, grab bars, or other equipment. We expect states and managed 
care plans to present the information in the directory with sufficient 
specificity to be useful to readers.
    Comment: We received numerous comments suggesting additional 
provider types for inclusion in Sec.  438.10(h)(2). We received one 
comment requesting clarification on the appropriateness of including 
personal care aids and providers who frequently do not have a business 
phone or address.
    Response: We appreciate the suggestions and clarify that the list 
in Sec.  438.10(h)(2) is a minimum; states and managed care plans 
should collaborate on any additional provider types to be included. 
States and plans should design the directory to be of maximum use for 
their program's enrollees and expand the list in Sec.  438.10(h)(2) as 
appropriate. For LTSS providers, we appreciate the sensitive nature of 
the services provided by certain types of LTSS providers and the lack 
of formal business information associated to them. We use the term 
``LTSS providers'' broadly in Sec.  438.10(h)(2) and expect states and 
plans to exercise judgment when determining whether to include certain 
LTSS provider types in the directory. To make this clear, we are adding 
``as appropriate'' after ``LTSS provider'' in the final rule.
    Comment: One commenter requested clarification on whether links 
could be used rather than including the networks of large 
subcontractors, such as pharmacy benefit managers.
    Response: We appreciate the opportunity to clarify that no 
provision in Sec.  438.10(h) would prohibit using links for large 
subcontracted networks in the on-line directory. However, a mechanism 
will have to be in place to provide the linked information in paper 
directories.
    Comment: We received several comments on proposed Sec.  438.10(h) 
including: Penalizing plans if there were errors in the directories 
because providers often fail to notify the plan of changes; the 
administrative burden and costs associated with strengthened provider 
directory requirements; requiring that managed care plans honor what is 
listed in the provider directory even if it erroneous; that plans, 
states, and CMS be required to monitor data for accuracy; that plans be 
held to a 97 percent accuracy rate; that plans exclude from the 
directory any providers that cannot be contacted; that plans verify 
data with providers monthly; and that plans be required to have 
mechanisms for enrollees to report inaccurate data.
    Response: We thank the commenters for their suggestions but decline 
to adopt these suggestions in the final rule. We understand the concern 
about managed care plans being held

[[Page 27730]]

accountable for errors in directories beyond their control and 
encourage managed care plans to work with their providers to ensure 
that their directories are as current and accurate as possible. We 
encourage managed care plans to facilitate multiple methods for 
providers to submit data changes and for enrollees to report 
inaccuracies. We urge states and managed care plans to develop 
innovative mechanisms to audit and verify the accuracy of their data 
and facilitate easy means for enrollees to report inaccurate data. 
Similarly, we understand the concern underlying the comments that 
managed care plans should honor what is listed in their directories 
even if there are errors as enrollees rely on directories to access 
providers and needed services; and we encourage that practice. We 
understand that there may be some administrative burden associated with 
maintaining accurate and timely directories, but believe it is 
necessary for enrollees to be fully informed about provider networks. 
We also believe that enrollees reasonably expect their managed care 
plan to make available an accurate provider directory, especially when 
the enrollee is expected to take action based on the information 
supplied by the managed care plan.
    Comment: We received many comments about the proposal in Sec.  
438.10(h)(4) requiring directories to be available in a machine 
readable format. Some commenters supported the provision that the 
format be specified by the Secretary and many recommended aligning with 
the format selected by the Marketplace. Other commenters suggested 
allowing states to select the format, a few suggested removing the 
requirement completely, and a few expressed concern over CMS providing 
sufficient implementation time for this provision.
    Response: We appreciate the comments on this proposed provision and 
understand the commenters' concerns. Aligning with the Marketplace and 
providing sufficient implementation time will be given serious 
consideration given the complexity of this proposed provision. We 
anticipate issuing clarifying guidance on this provision when 
additional details on machine readable formats become available.
    Comment: Many commenters expressed support for proposed Sec.  
438.10(i) as they believe having formulary information is critical to 
enrollees. We received some comments recommending that a specific time 
frame be established for updating the electronic formulary proposed in 
Sec.  438.10(i). Commenters believed a timeframe was necessary to 
ensure that managed care plans maintained and updated the information 
in a timely fashion.
    Response: We agree with the commenters that having accurate 
information is critical for enrollees; however, revisions to a 
formulary are often contingent on the actions of a state and/or managed 
care plan's pharmaceutical and therapeutics committee. As such, there 
is great variation in the timing of revisions. We do not believe that 
we can effectively select a specific time frame that would accommodate 
such variation. Therefore, we are finalizing Sec.  438.10(i) as 
proposed.
    Comment: A few commenters suggested that pre-authorization criteria 
and the exception process for non-formulary drugs be included in the 
formulary proposed in Sec.  438.10(i). Commenters believed this 
information would be useful to enrollees.
    Response: We do not agree that including this information in the 
formulary would be helpful to most enrollees given the large volume of 
information and its highly technical nature. Additionally, formularies 
can be lengthy and adding a large amount of additional information that 
is not valuable to most readers does not seem beneficial. We 
acknowledge that states are free to include the pre-authorization 
criteria if they choose to, along with any other information they 
believe useful to the enrollee, but we do not believe adding it as a 
requirement to Sec.  438.10(i) is necessary.
    Comment: Some commenters suggested that information on the process 
for obtaining an emergency supply of a drug be required in Sec.  
438.10(i). A few commenters asked CMS to require plans to identify both 
the level of cost sharing for drugs in each tier for coverage as well 
as the actual cost the patient will incur for each drug.
    Response: While we agree that this information may be useful to 
enrollees, we believe that information on the process for obtaining an 
emergency supply and cost sharing should already be in the enrollee 
handbook. While we do not believe we need to mandate the inclusion of 
such information in the formulary, states are free to include this 
information at their discretion.
    Comment: A few commenters suggested that a managed care plan be 
required to notify its enrollees if it removes a drug from its 
formulary.
    Response: Given the wide variation in formulary management 
practices, we decline to mandate notification to enrollees for the 
removal of each drug. However, states and managed care plans are free 
to require and implement, respectively, such notification if they so 
choose.
    Comment: One commenter requested that CMS revise Sec.  
438.102(b)(2) to incorporate Sec.  438.10(g)(2)(ii)(B) that requires 
the managed care plan to inform enrollees through the enrollee handbook 
on how to obtain information from the state for accessing covered 
services that the managed care plan does not cover due to moral or 
religious reasons.
    Response: We agree that Sec.  438.102(b)(2) could be more 
consistent with Sec.  438.10(g)(2)(ii)(B) and with the underlying 
statutory requirements (section 1932(b)(3) of the Act); we are 
modifying as appropriate. Additionally, we are correcting an error in 
Sec.  438.102(b)(1)(ii)(A) and (b)(2) by removing the term ``potential 
enrollees.'' The term ``potential enrollee'' should not be included in 
these paragraphs as Sec.  438.102(b) addresses information that must be 
provided by the managed care plan. Information to potential enrollees 
is generally a state responsibility under Sec.  438.10, which we 
discussed as part of our proposal; we are making this change to ensure 
that part 438, as finalized here, is internally consistent on this 
point.
    After consideration of the public comments, we are finalizing Sec.  
438.10 as proposed with the following revisions:
     In Sec.  438.10(a), added a definition of ``limited 
English proficient''; and removed ``consistent with standards [used by 
OCR]'' from the definition of ``prevalent''; and supplemented the 
examples of ``modern accessibility standards'' in the definition of 
``readily accessible''.
     In Sec.  438.10(c)(3), added a cross reference to Sec.  
438.10(i); removed references to Sec. Sec.  438.68(e), 438.364(b)(2), 
and 438.602; and revised the text to improve its readability.
     In Sec.  438.10(c)(4)(i), added ``and devices'' after 
``habilitation services'' and ``rehabilitation services''.
     In Sec.  438.10(c)(4)(ii), changed ``member'' to 
``enrollee'' in front of ``handbook'' for consistency as ``member'' is 
not defined in this part. This correction was made throughout part 438.
     In Sec.  438.10(c)(6)(ii), used the phrase ``applicable 
entity's'' to refer to the State, MCO, PIHP, PAHP, PCCM or PCCM entity 
regulated by paragraph (c)(6).
     In Sec.  438.10(c)(6)(v), removed ``State, MCO, PIHP, 
PAHP, or PCCM entity'' as it was duplicative of the list in paragraph 
(c)(6); moved ``is informed'' for grammatical flow; used ``applicable

[[Page 27731]]

entity'' to refer to the applicable regulated entity; and changed ``5 
calendar days'' to ``5 business days'' for mailing information 
requested on paper.
    In Sec.  438.10(d)(2), added ``interpretation'' after 
``oral'' and ``translation'' after ``written'' for clarity.
     In Sec.  438.10(d)(3), added ``denial and termination 
notices'' to the list of documents that must be translated upon 
request; and rearranged some parts of the paragraph to improve 
readability.
     In Sec.  438.10(d)(5)(i), revised ``written information'' 
to ``written translation'' for accuracy and consistency.
     In Sec.  438.10(d)(5)(iii), replaced ``those services'' 
with a specific cross references for better clarity.
     In Sec.  438.10(e)(1)(i), added ``managed care'' to 
references to voluntary and mandatory programs for clarity.
     In Sec.  438.10(e)(2), added ``all of'' to clarify that 
items (i) through (x) are required.
     In Sec.  438.10(e)(2)(iii), added requirement that notices 
to potential enrollees must include information on the length of the 
enrollment period and all disenrollment opportunities available to 
them.
     In Sec.  438.10(e)(2)(vi), added ``and formulary'' and 
``and (i)'' to information that must be provided to potential 
enrollees.
     In Sec.  438.10(g)(2) replaced ``member'' with 
``enrollee'' and in paragraph (ii)(A), added `by the MCO, PIHP, PAHP, 
or PCCM entity'' at the end of the sentence for clarity.
     In Sec.  438.10(g)(2)(ii)(B), replaced ``those services'' 
with a specific cross reference for better clarity.
     In Sec.  438.10(g)(2)(vii), added a requirement that 
freedom of choice of family planning providers be included in the 
handbook.
     In Sec.  438.10(g)(2)(xi)(E), and (h)(1)(viii), made 
revisions for grammatical flow.
     In Sec.  438.10(h)(1)(vii), changed ``spoken'' to 
``offered'' to recognize sign language and added a reference to 
cultural competence training to add consistency to the way the 
information is presented in the provider directory.
     In Sec.  438.10(h)(1)(viii), changed ``is accessible'' to 
``has reasonable accommodations'' for clarity.
     In Sec.  438.10(h)(2)(v), added ``as appropriate'' after 
``LTSS providers'' to acknowledge that certain types of providers may 
not be suitable for display in a provider directory.
    After consideration of public comment, we are amending Sec.  
438.102(b)(2) to be consistent with Sec.  438.10(g)(2)(ii)(B) and the 
underlying statutory requirements.
e. Primary Care Case Management (Sec. Sec.  438.2, 438.3, 438.330, 
438.340, and 438.350)
    PCCM services have a unique status in the Medicaid program. PCCM 
services are considered a state-plan covered benefit through section 
1905(a)(25) of the Act. Section 1905(t) of the Act defines PCCM 
services, the providers that may furnish them, and the standards for a 
PCCM contract--one of which is that the state's contract with the PCCM 
complies with applicable sections of 1932 of the Act (the managed care 
rules in the statute). A PCCM, as defined in section 1905(t)(2) of the 
Act, is considered a managed care entity under section 
1932(a)(1)(B)(ii)of the Act. Current regulatory standards in part 438 
have minimal standards that PCCM programs have to meet; they generally 
mirror the statutory standards specified in section 1932 of the Act.
    Current regulations reflect the prevailing PCCM program design that 
existed in 1998. At that time, virtually all PCCM programs were 
intended to layer a `gatekeeper' model on top of states' FFS programs. 
Each primary care provider who acted as a PCCM was paid a small monthly 
fee (typically less than $5.00) per beneficiary in recognition of the 
provision of PCCM services, in addition to any direct service payment 
the provider might also receive from the state, to coordinate access to 
primary care services and manage referrals to specialty care for 
Medicaid beneficiaries. The Medicaid provider was not held accountable 
for quality or health outcomes for that enrollee. We believe the 
current regulatory structure still works reasonably well for these 
`gatekeeper' PCCM programs, which generally are very small and remain 
exclusively focused on individual primary care providers.
    Over the past 8 years, however, states have determined that they 
need additional tools to better manage utilization of Medicaid 
services. In the proposed rule in section I.B.6.e, we discussed the 
history of the PCCM model, noting the evolution of PCCM entities and 
the fact that there current regulations in part 438 do not explicitly 
address them. We noted that typically, a more robust PMPM fee has been 
paid to these entities, depending upon the scope of activities under 
the contract; however, these payments are not considered risk-based 
capitation payments subject to the actuarial soundness standards of 
Sec.  438.4 through Sec.  438.7 because the entities are not 
responsible for the provision of medical services under the state plan. 
Rather, the state continues to pay for medical services on a FFS basis. 
As these PMPM fees are not subject to the actuarial soundness 
standards, federal review and approval of these payments has been 
limited. Therefore, we proposed to adopt a term for these more 
intensive care case management entities: PCCM entities. Our proposed 
term reflects our view that these entities are PCCMs subject to the 
statutory minimum standards for PCCMs but by distinguishing these 
entities from the traditional PCCM model--one based on the use of 
individual providers to act as gatekeepers--we proposed to exercise our 
authority under section 1902(a)(4) of the Act to adopt additional 
standards for those PCCM entities that provide more intensive case 
management and care coordination, measure performance outcomes and 
quality improvement activities, and receive higher reimbursement.
    We proposed to also distinguish the PCCM programs that are 
considered managed care, and therefore, subject to the specified 
standards of part 438, from other health care delivery systems, such as 
integrated care models, patient-centered medical homes, and ACOs, which 
would remain outside the purview of the regulatory changes to part 438 
we proposed. We also noted that SMDLs issued in 2012 outlined new 
flexibilities for states to implement integrated care models that fall 
on the spectrum between unmanaged FFS and full-risk managed care. SMDL 
#12-002, available at http://www.medicaid.gov/Federal-Policy-Guidance/downloads/SMD-12-002.pdf, specifically highlighted that primary care 
case management is a state plan service, which does not necessarily 
have to be a managed care delivery system.
    Notwithstanding the guidance in those SMDLs, we noted that states 
continue to seek clarification on the attributes of a PCCM program that 
make it ``managed care'' and they perceive that there are additional 
burdens if the program is considered a managed care program. We 
clarified in the proposed rule that states may operate PCCM programs--
under the rubric of integrated care models, ACOs or other similar 
terms--without triggering the standards of part 438 (which include 
additional contractual obligations) as long as enrollees' freedom of 
choice is not constrained and any willing and qualified provider can 
participate--that is, where traditional FFS rules for provider 
participation remain in place. For such programs that use FFS provider 
participation, only the statutory standards in section 1905(t) of the 
Act that apply to PCCM contracts will apply, and not our further

[[Page 27732]]

interpretations and applications of the provisions of section 1932 of 
the Act. We requested comment on this proposal and our underlying 
analysis; further, we requested comment on whether we should consider 
further rulemaking to better explain these differences.
    Specifically, we proposed in Sec.  438.2 to update definitions for 
primary care case management and PCCM. We proposed to modify the 
existing definition in Sec.  438.2 for a ``primary care case management 
system'' as a system under which a state contracts either with an 
individual (PCCM) to provide case management services or when a state 
contracts with an entity to furnish case management services or a 
defined set of functions that go beyond case management services. We 
also proposed to remove the reference to an ``entity'' under the 
existing definition of ``primary care case manager'' as an ``entity'' 
that provides primary care case management services is defined in the 
proposed new definition of ``PCCM entity'' that would permit a broader 
scope of functions to be provided than those focused on primary care 
case management services; these include such activities as intensive 
case management, development of enrollee care plans, execution of 
contracts and/or oversight responsibilities for the activities of FFS 
providers, provision of payments to FFS providers, enrollee outreach 
and education, operation of a customer service call center, provider 
profiling and quality improvement and measurement, coordination with 
behavioral health providers, and coordination with LTSS providers. We 
believe these functions are included in the range of functions that 
current PCCM programs cover.
    We also proposed throughout the proposed and final rule and in the 
revisions to part 438, to include a reference to a PCCM entity wherever 
there was an existing standard on PCCMs. We also identified those 
standards that only apply to PCCM entities when they undertake certain 
responsibilities on behalf of the state. We proposed to move Sec.  
438.3(k) to Sec.  438.3(q) which implements the statutory provisions in 
section 1905(t) of the Act for PCCM contracts.
    In addition, we proposed a new Sec.  438.3(r) to have states obtain 
our approval of PCCM entity contracts. This proposed paragraph also 
specifies new standards that we propose elsewhere in this rule. For 
PCCM entities that have the same administrative responsibilities and 
financial incentives as MCOs, PIHPs, and PAHPs, states which hold their 
PCCM entities accountable for provider behavior and quality outcomes 
would have to monitor and evaluate the performance of their networks 
accordingly. We noted that those PCCM entity contracts which provide 
for shared savings or other payment incentives--the same financial 
incentives that managed care plans have--should be held to higher 
standards in terms of enrollee information and quality improvement.
    We also proposed changes to the following sections to effectuate 
these new standards related to PCCM entities that were also discussed 
in proposed Sec.  438.3(r) in section I.B.2. of the proposed rule: 
Sec. Sec.  438.10; 438.330; 438.340; and 438.350. However, we did not 
propose to subject traditional PCCMs to these standards because PCCMs 
are not responsible for the activities that PCCM entities are 
responsible for under our proposed framework. In Sec.  438.10, we 
proposed to treat PCCM entities like MCOs, PIHPs and PAHPs in areas 
including oral and written translation standards; general and 
miscellaneous enrollee information standards; and enrollee handbook and 
provider directory content standards. In Sec. Sec.  438.330, 438.340 
and 438.350, we proposed small modifications in each section, as 
follows, to propose new standards for PCCM entities:
     In Sec.  438.330, we proposed that states assess the 
performance of each PCCM entity to detect over- and underutilization of 
services; measure performance using standard measures; and conduct a 
program review.
     In Sec.  438.340, we proposed that the state's quality 
strategy, consistent with the guidance provided in SMDL #13-007, 
describe how the state is assessing the performance and quality 
outcomes achieved by each PCCM entity.
     In Sec.  438.350, we proposed, based on inquiries received 
by states with PCCM entities, that the state may have their EQRO 
perform an EQR of each PCCM entity. Since EQRs of MCOs, PIHPs, and 
PAHPs focus on the operation of the managed care plan, we believe that 
applying similar review principles to PCCM entities is reasonable and 
appropriate.
    We received the following comments in response to our proposal to 
revise Sec. Sec.  438.2, 438.3, 438.330, 438.340, and 438.350.
    Comment: Many commenters supported the distinction between PCCMs 
and PCCM entities at Sec.  438.2. Several commenters recommended that 
CMS clarify whether the definition of a PCCM entity includes ACOs, 
integrated care models, or patient-centered medical home (PCMH) 
programs. Commenters also recommended that CMS clarify whether the 
regulations throughout part 438 apply to ACOs, integrated care models, 
or PCMH programs. A few commenters recommended that CMS define ACOs for 
both the Medicare and Medicaid programs. One commenter recommended that 
CMS establish and define a new entity that delivers comprehensive 
specialty services across the whole state, or a specific and defined 
geographic region.
    Response: We clarify that the definition of PCCM entity does not 
include ACOs, integrated care models, or PCMH programs. As discussed in 
the proposed rule (80 FR 31163), states operating ACOs, integrated care 
models, or PCMH programs are outside of the purview of Medicaid managed 
care and are not bound by 42 CFR part 438. We decline to define ACOs 
for both the Medicare and Medicaid programs, as this is not within the 
scope of this rule. We also decline to establish and define a new 
entity that delivers comprehensive specialty services across the whole 
state, or a specific and defined geographic region. If an organization 
is providing comprehensive services under a risk contract across the 
whole state, or a specific and defined geographic region, it must meet 
the requirements at section 1903(m) of the Act, and the organization is 
a MCO. If an organization is providing a more limited set of specialty 
benefits or services under a contract with the state and on the basis 
of risk-based, capitation payments that do not use state plan payment 
rates, such an organization is a PAHP. We are available to provide 
technical assistance to states to determine the appropriate regulatory 
framework for models under consideration.
    Comment: A few commenters recommended that CMS modify the 
definition of PCCM at Sec.  438.2 to include a clinical nurse 
specialist (CNS), a registered nurse (RN), and other licensed 
practitioners, including occupational therapists (OT) and a broader 
range of primary care providers.
    Response: We decline to accept commenters' recommendations to 
include a CNS, a RN, and other licensed practitioners, including OT and 
a broader range of primary care providers in the definition of PCCM, as 
we lack the statutory authority to do so. Section 1905(t)(2) of the Act 
defines ``PCCM'' and that definition is limited to a physician, a 
physician group practice, or an entity employing or having other 
arrangements with physicians, or at state option, a nurse practitioner, 
a certified nurse-midwife, or a physician assistant.

[[Page 27733]]

    Comment: Many commenters supported the distinction between PCCM and 
PCCM entity contract requirements at Sec.  438.3(q) and (r). A few 
commenters recommended that CMS clarify the additional requirements for 
PCCM entity contracts that provide incentive payments or other 
financial rewards for improved quality outcomes. One commenter 
recommended that CMS clarify the difference between program level PCCM 
entity incentive payments and PCCM entity individual primary care 
physician incentive payments.
    Response: We clarify for commenters that consistent with proposed 
Sec.  438.3(r), if the state's contract with the PCCM entity provides 
for shared savings, incentive payments, or other financial rewards for 
improved quality outcomes, the state must comply with the requirements 
at Sec.  438.330(b)(2), (b)(3), (c), and (e), Sec.  438.340, and Sec.  
438.350. As discussed in the proposed rule (80 FR 31164), states 
pursuing models that rely on measurable quality improvements as the 
basis for validation of payment must articulate a quality strategy that 
describes the state's overall goals and interventions. It is unclear to 
us why the commenter views program level PCCM entity incentive payments 
and PCCM entity individual primary care physician incentive payments 
differently. Generally, PCCM entity incentive payments are shared among 
individual primary care physicians within the PCCM entity and can vary 
based on individual primary care physician performance. Such terms 
would be specified in the contract between the PCCM entity and 
individual primary care physicians and would not be appropriate for us 
to clarify in regulation.
    After consideration of the public comments, we are finalizing all 
sections discussing PCCMs and PCCM entities as proposed.
f. Choice of MCOs, PIHPs, PAHPs, PCCMs, and PCCM Entities (Sec.  
438.52)
    As noted in our proposed rule in section I.B.6.f., one of the key 
principles in federal statute and regulations is that enrollees--to the 
maximum extent possible--have a choice of more than one managed care 
plan. Section 1932(a)(3) of the Act requires that choice be an element 
of a mandatory managed care program for MCOs and PCCMs. In the 2002 
final rule at current Sec.  438.52, an application of that standard 
exists for PIHPs and PAHPs.
    We proposed modifications to Sec.  438.52(a) to clarify current 
standards regarding the choice of two entities. Under the current 
regulation, states must give enrollees a choice of at least two MCOs, 
PIHPs, PAHPs, or PCCMs if enrollment with such an entity is required to 
receive Medicaid benefits. In paragraph (a)(1), we proposed to remove 
the reference to PCCM and provide that states that enroll beneficiaries 
in an MCO, PIHP or PAHP must give those beneficiaries a choice of at 
least two MCOs, PIHPs or PAHPs. As background, in the proposed rule, we 
proposed to separate PCCMs that are an individual physician (or 
physician assistant or certified nurse mid-wife) or a physician group 
practice from an entity or organization that employs such providers and 
performs services on the state's behalf in addition to basic primary 
case management services. That proposal underlies the proposed 
amendments here for how the statutory choice standards would be 
implemented for PCCMs and PCCM entities. In paragraph (a)(2), we 
proposed that in a primary care case management system, as currently 
defined in Sec.  438.2, beneficiaries must be permitted to choose from 
at least two PCCMs employed by or contracted with the state. In 
paragraph (a)(3), we proposed that beneficiaries who must enroll in a 
PCCM entity may be limited to one PCCM entity, but beneficiaries must 
be permitted to choose from at least two PCCMs employed by or 
contracted with the PCCM entity.
    We received the following comments on proposed Sec.  438.52(a).
    Comment: A few commenters supported Sec.  438.52(a) as proposed, 
while other commenters recommended that CMS revise the requirements at 
paragraphs (a)(1) and (3). A few commenters recommended that CMS 
exclude PIHPs and PAHPs from the requirement at paragraph (a)(1) for a 
state to offer enrollees a choice of at least two managed care plans. 
Commenters stated that PIHPs and PAHPs provide a very narrow scope of 
services and should therefore be exempt from the choice requirement. A 
few commenters also recommended at paragraph (a)(1) that CMS allow the 
option for a single statewide MCO. A few commenters recommended that 
CMS require choice for PCCM entities at paragraph (a)(3) consistent 
with the requirement to offer choice for MCOs, PIHPs, and PAHPs at 
paragraph (a)(1). Commenters stated that PCCM entities and PCCM entity 
operations take on similar characteristics of MCOs, and therefore CMS 
should treat PCCM entities more like MCOs than traditional PCCMs for 
enrollee choice.
    Response: We thank commenters for their support and recommendations 
at Sec.  438.52(a) but decline to adopt commenters' recommendations. 
Section 1932(a)(3)(A) of the Act requires states to permit an 
individual to choose a managed care entity from not less than two such 
entities for both MCOs and PCCMs. This statutory directive means that 
enrollees must have choice between at least two MCOs, as specified in 
paragraph (a)(1), and between at least two PCCMs, as specified in 
paragraph (a)(2). Consistent with our authority at section 1902(a)(4) 
of the Act, we included PIHPs and PAHPs in this choice requirement, see 
67 FR 41020. Therefore, we decline to allow states to implement a 
single statewide MCO in a mandatory enrollment program, as this is 
statutorily prohibited. In addition, we disagree with commenters and 
decline to adopt recommendations to exclude PIHPs and PAHPs from the 
choice requirement. By definition, PIHPs and PAHPs cover a more limited 
set of services than MCOs but still limit enrollees to a network of 
providers to obtain those services. We maintain that enrollee choice is 
important for PIHPs and PAHPs.
    While we understand commenters' concerns regarding choice for PCCM 
entities, that is, that choice would be operationalized at the PCCM 
level as is the case for PCCMs, we decline to require choice at the 
PCCM entity level. While PCCM entities and MCOs may share similar 
characteristics, such as quality improvement activities for providers, 
the operation of a customer service call center, or claims processing, 
we believe that PCCM entities are fundamentally different in that they 
are focused solely on care coordination activities and arranging for 
the provision of services outside of the PCCM entity. In other words, 
enrollees are not bound by a provider network to obtain services that 
the PCCM under the PCCM entity may coordinate with as those services 
are rendered FFS. We also believe that PCCM entity models vary greatly 
by state, and we recognize that a blanket choice requirement at the 
PCCM entity level could be disruptive to mature and successful programs 
already in operation.
    Comment: Several commenters recommended that CMS include at Sec.  
438.52(a) the requirement that at least one managed care plan must 
provide the full range of reproductive health services covered in the 
State plan, to the extent that such reproductive health services fall 
within the scope of the services covered under the managed care plan's 
contract.
    Response: We appreciate commenters' recommendations to include this 
requirement but decline to do so, as we believe it is duplicative and

[[Page 27734]]

unnecessary. Consistent with Sec.  438.206(a), each state must ensure 
that all services covered under the State plan, including the full 
range of reproductive health services covered in the State plan, are 
available and accessible to enrollees of managed care plans. Further, 
consistent with Sec.  438.206(b)(4), if the managed care plan's network 
is unable to provide necessary services covered under the contract to a 
particular enrollee, the managed care plan must adequately and timely 
cover these services out of network.
    After consideration of public comments, we are finalizing Sec.  
438.52(a) as proposed without modification.
    Section 1932(a)(3)(B) of the Act provides an exception to the 
standard that an enrollee have the choice of at least two MCOs, or 
PCCMs, if applicable, for states with rural areas. This exception is 
reflected in the current regulations at Sec.  438.52(b), wherein the 
exception to choice was extended to PIHPs and PAHPs. We proposed two 
significant changes to the implementation of the rural area exception. 
First, as a consequence of our proposal to change the implementation of 
the enrollee choice standards, we proposed to eliminate the rural 
exception for PCCMs.
    We proposed to change the definition of a rural area for purposes 
of the state option to contract with one MCO, PIHP, PAHP, or PCCM under 
mandatory Medicaid managed care programs. The current definition of a 
rural area at Sec.  438.52(b)(3) is any area other than an ``urban'' 
area as specified in the Office of Management and Budget's (OMB) 
delineation of Metropolitan Statistical Areas (hereinafter OMB 
Bulletin). We noted that the OMB Bulletin produces geographic 
distinctions focused on a core population center that has a high degree 
of social and economic integration with adjacent territories as 
measured by commuting ties, which can include less densely populated 
areas within a Metropolitan Statistical Area (MSA). Further, OMB has 
consistently warned against the non-statistical use of the delineations 
within the OMB Bulletin, noting that: ``Metropolitan and Micropolitan 
Statistical Area Standards do not produce an urban-rural 
classification, and confusion of these concepts can lead to 
difficulties in program implementation [for programs that rely on such 
distinctions].'' See for example 75 FR 37236 (June 28, 2010).
    Because we have encountered a number of states seeking to contract 
with one MCO, PIHP, PAHP, or PCCM system in sparsely populated counties 
that are classified as part of an MSA that cannot meet the current 
regulatory definition for a rural area, we proposed changes to this 
standard.
    We proposed to adopt Medicare's county-based classifications to set 
network adequacy standards under the MA program. As noted in the 
proposed rule, Medicare establishes population and density parameters 
based on approaches taken by the Census Bureau in defining ``urbanized 
areas'' and OMB's delineation of ``metropolitan'' and ``micropolitan'' 
areas. These parameters are then used to set nationwide county 
designations as ``large metro,'' ``metro,'' ``micro,'' ``rural,'' or 
``Counties with Extreme Access Considerations (CEAC).'' The county 
designations are published annually in the MA Health Services Delivery 
(HSD) Reference file, which is accessible at the MA Applications page 
at http://www.cms.gov/Medicare/Medicare-Advantage/MedicareAdvantageApps/index.html?redirect=/MedicareAdvantageApps/. We 
proposed that a county with a designation other than large metro or 
metro would fall under the definition of a rural area for purposes of 
the rural exception to choice. We believe that the Medicare county 
designations would be easy for states to research and for us to confirm 
a county's classification as rural. In addition, we believe that a 
number of states that were barred from exercising the rural exception 
to choice under the existing standard would see greater flexibility 
with the proposed change. We believe that the modification to the 
definition of a ``rural'' area for purposes of exercising the exception 
to choice of managed care plans addresses past challenges faced by some 
states. However, consistent with the key principle in favor of managed 
care plan choice outlined earlier, we continue to encourage the 
provision of such choice to beneficiaries where feasible.
    We noted that we considered adopting the geographic distinctions 
used by the Office of Rural Health Policy (ORHP) within the Health 
Resources and Services Administration (HRSA) for purposes of 
determining a provider's eligibility for grant funding available 
through that agency. ORHP's definition of a rural area identifies lower 
population counties or census tracts within a county that otherwise 
fall under OMB's delineation of MSAs. Census tracts are defined at the 
zip code rather than county level, so it is possible for a county to 
include multiple census tracts of different population densities. If we 
were to adopt ORHP's approach, we would need to establish a review 
standard for a county that as a whole did not qualify as rural and 
states would have the burden of researching the nature and scope of the 
census tracts to meet the standard.
    We received the following comments in response to our proposal to 
revise Sec.  438.52(b).
    Comment: Several commenters supported the rural exception provided 
at Sec.  438.52(b)(1), which allows a state to limit a rural resident 
to a single managed care plan consistent with section 1932(a)(3)(B) of 
the Act. A few commenters opposed Sec.  438.52(b)(1) and stated that 
the needs of rural areas should be balanced with adequate enrollee 
choice. A few commenters recommended that CMS waive mandatory managed 
care requirements or require states to provide a FFS option for rural 
residents that are limited to a single managed care plan. A few 
commenters also recommended that CMS include specific network adequacy 
and timely access to care requirements for states that limit rural 
residents to a single managed care plan.
    Response: We decline to adopt commenters' recommendations as they 
are not consistent with the requirements at section 1932(a)(3)(B) of 
the Act, which permits states the option to limit a rural resident to a 
single MCO if states comply with the requirements we have codified at 
Sec.  438.52(b)(2). Through our authority under section 1902(a)(4) of 
the Act, we extended the rural exception to PIHPs and PAHPs. We also 
decline to waive mandatory managed care requirements or require states 
to provide a FFS option for rural residents that are limited to a 
single managed care plan, as section 1932(a)(3)(B) of the Act 
explicitly references managed care programs with mandatory enrollment. 
Finally, we decline to add specific network adequacy and timely access 
to care requirements for states that limit rural residents to a single 
managed care plan, as such requirements are already applied broadly for 
all states and managed care plans at Sec.  438.68 and Sec.  
438.206(c)(1).
    Comment: Several commenters provided recommendations for revisions 
at Sec.  438.52(b)(2). One commenter recommended that CMS permit states 
to waive the requirement for choice of primary care providers at Sec.  
438.52(b)(2)(i). One commenter opposed Sec.  438.52(b)(2)(ii)(B)(1) 
regarding the requirement that a provider be given the opportunity to 
become a participating provider under the same requirements for 
participation in the managed care plan's network as other network 
providers of that type. The commenter stated that managed care plans 
must be given absolute discretion to manage their provider

[[Page 27735]]

networks and exclude providers as appropriate.
    A few commenters recommended that the requirements at paragraph 
Sec.  438.52(b)(2)(ii)(C) regarding moral or religious objections be 
included broadly for all enrollees and not be limited only to enrollees 
of rural areas that have been limited to a single managed care plan. 
Finally, several commenters recommended that CMS include requirements 
at Sec.  438.52(b)(2)(ii) to specify that the single managed care plan 
must provide the full range of reproductive health services covered in 
the State Plan and recommended that CMS include specific references to 
Sec.  438.62 regarding continued services to enrollees and Sec.  
438.206(a) regarding access to State plan services.
    Response: We decline the commenter's recommendation at Sec.  
438.52(b)(2)(i) to waive the requirement for choice of primary care 
providers, as this is not consistent with the statutory language at 
section 1932(a)(3)(B)(i) of the Act, which requires states limiting a 
rural resident to a single MCO to offer the individual the choice of 
not less than two physicians or case managers. We also decline to 
remove Sec.  438.52(b)(2)(ii)(B)(1) and clarify for the commenter that 
such requirements do not limit the managed care plan's discretion to 
manage their provider networks and exclude providers as appropriate. 
The regulatory text at Sec.  438.52(b)(2)(ii)(B)(1) and (2) provide 
that such providers must meet all of the same requirements for 
participation in the managed care plan's network as other network 
providers of that type and if the provider does not meet the necessary 
requirements to join the managed care plan's network, the enrollee can 
be transitioned to a participating provider within 60 calendar days 
after being given an opportunity to select a provider who participates 
in the managed care plan's network.
    We remind commenters that paragraph Sec.  438.52(b)(2)(ii)(C) 
related to moral or religious objections is not limited to enrollees of 
rural areas that have been limited to a single managed care plan. 
Within part 438, we have included the appropriate references for moral 
and religious objections at Sec. Sec.  438.10(e)(2)(v)(C), 
438.10(g)(2)(ii)(A) and (B), and 438.100(b)(2)(iii) for all enrollees 
of managed care plans. We did not accept the suggestion to add 
requirements at Sec.  438.52(b)(2)(ii) to specify that the single 
managed care plan must provide the full range of reproductive health 
services covered in the State plan or include specific references to 
Sec.  438.62 regarding continued services to enrollees or Sec.  
438.206(a) regarding access to State plan services, as we find these 
recommendations to be duplicative of existing requirements. The 
requirements at Sec. Sec.  438.62 and 438.206(a) are applicable for all 
enrollees of managed care plans; therefore, specific references are not 
required at Sec.  438.52(b)(2)(ii). Consistent with Sec.  438.206(a), 
each state must ensure that all services covered under the State Plan, 
including the full range of reproductive health services covered in the 
State Plan, are available and accessible to enrollees of managed care 
plans. Further, consistent with Sec.  438.206(b)(4), if the managed 
care plan's network is unable to provide necessary services covered 
under the contract, to a particular enrollee, the managed care plan 
must adequately and timely cover these services out of network for the 
enrollee.
    Comment: Many commenters supported Sec.  438.52(b)(3) regarding the 
definition and criteria of rural area. A few commenters recommended 
that CMS allow states the option to use the definition and criteria of 
rural area that best meets the state's specific needs and 
circumstances. Other commenters recommended that CMS retain OMB's 
definition and criteria of rural area. A few commenters recommended 
that states be allowed to use the rural distinctions used by the ORHP 
within HRSA. One commenter recommended that CMS include specific 
criteria for managed care plans in metro areas that serve small and 
complex populations. The commenter recommended that CMS include such 
areas in the definition and criteria of rural area for purposes of 
granting a rural exception and allowing the state to limit those 
enrollees to one single managed care plan. Several commenters 
recommended that CMS add requirements at Sec.  438.52(b)(3) to ensure 
that states utilizing the rural exception have demonstrated that no 
additional managed care plans will serve the specific rural area. 
Finally, one commenter recommended that CMS clarify that if more than 
one managed care plan is currently serving a rural area, the state 
cannot implement a rural exception until the end of the next contract 
end date.
    Response: We decline to revise the definition and criteria of rural 
area at Sec.  438.52(b)(3), as we believe the Medicare county-based 
classifications better reflect our intent for the provision and permits 
more flexibility for states pursuing the rural exception. We also 
decline commenters' recommendations to give states the option of which 
rural area definition to use, or to allow states the option to still 
utilize the OMB criteria or the rural distinctions used by the ORHP 
within HRSA. As discussed in the preamble to the proposed rule at 80 FR 
31165, we considered ORHP's approach but concluded that applying the 
census tract unit of measure, which is determined at the zip code 
level, would be difficult to apply in this context as the usual unit of 
measure for managed care service areas is county-based.
    We believe that a consistent approach is necessary to ensure that 
the rural exception is applied uniformly across all managed care 
programs and populations. We disagree with the commenter that we should 
add specific criteria for managed care plans in metro areas that serve 
small and complex populations and include such areas in the definition 
and criteria of rural area for purposes of granting a rural exception 
and allowing the state to limit those enrollees to one single managed 
care plan. This recommendation is not consistent with the language in 
section 1932(a)(3)(B) of the Act, which provides the exception for an 
individual residing in a rural area. The recommendation is also not 
consistent with the requirement in section 1932 of the Act that states 
are expected to maintain enrollee choice in non-rural areas regardless 
of the populations served. We also decline to add requirements at Sec.  
438.52(b)(3) to ensure that states utilizing the rural exception have 
demonstrated that no additional managed care plans will serve the 
specific rural area. This recommendation is operational in nature, and 
we believe it is unnecessary to include in the regulatory text. 
Finally, we note and clarify that if multiple managed care plans are 
currently being offered in a rural area, it is our expectation that 
states continue to allow choice. It would not be appropriate for states 
to pursue the rural exception if multiple managed care plans meet the 
state's requirements and are willing to serve in specific rural areas.
    After consideration of the public comments, we are finalizing Sec.  
438.52(b) as proposed with a modification with the correct reference to 
``County with Extreme Access Considerations'' in the regulatory text at 
paragraph (b)(3).
    We did not receive comments on proposed Sec.  438.52(c) and (d) and 
will finalize those provisions as proposed without modification.
g. Non-Emergency Medicaid Transportation PAHPs (Sec.  438.9)
    As states' managed care programs have matured, states have used 
PAHPs for a broader scope of services than was initially considered 
when the Medicaid managed care rules were finalized in

[[Page 27736]]

2002. With that in consideration, we proposed additional provisions 
throughout part 438 to address PAHPs providing medical services (as 
currently defined in Sec.  438.2) which were discussed throughout the 
proposed rule. However, we noted that we understand that states may 
also use a PAHP structure to deliver only NEMT services when they are 
not using the state plan brokerage option authorized through section 
1902 of the Act or providing NEMT through Medicaid FFS or as an 
administrative activity. We also noted that we did not believe that 
states and PAHPs providing only NEMT services should have to comply 
with the full scope of PAHP provisions included in part 438. Therefore, 
we proposed to amend the existing Sec.  438.8 to include only the 
specific provisions applicable to NEMT PAHPs.
    First, we proposed to change the section number of Sec.  438.8 to 
Sec.  438.9 because of additional sections added to the beginning of 
the subpart. Second, in an effort to avoid duplicative information, we 
proposed to delete the existing language in paragraphs (a) and (b) as 
all the PIHP and PAHP provisions listed in the existing paragraphs are 
specified throughout the regulatory text of part 438 and, therefore, it 
was unnecessary to include a separate section listing the standards 
applicable to PIHPs and PAHPs. We proposed a new paragraph (a) which 
defines an NEMT PAHP as an entity that provides only NEMT services to 
enrollees under contract with the state on a pre-paid capitated basis 
or other payment arrangement that does not use state plan payment 
rates. If a state chooses to use a PAHP to provide NEMT services along 
with any other ambulatory medical service, that PAHP would then be 
considered a traditional PAHP as defined in Sec.  438.2 and all the 
PAHP provisions throughout part 438 would apply. Lastly, in paragraph 
(b), we list the specific provisions in part 438 that would apply to 
NEMT PAHPs in the same way they apply to any other PAHP. The provisions 
that apply include contracting provisions, actuarial soundness 
standards, information standards, anti-discrimination provisions, 
certain state responsibility provisions, certain enrollee rights and 
responsibilities, certain PAHP standards, enrollee right to fair 
hearings, and certain program integrity standards.
    We received the following comments in response to our proposal to 
revise Sec.  438.8 to include only the specific provisions applicable 
to NEMT PAHPs and to change the section number from Sec.  438.8 to 
Sec.  438.9.
    Comment: A few commenters recommended that CMS require NEMT PAHPs 
to comply with all of the same requirements as PAHPs throughout part 
438. A few commenters specifically recommended that CMS require NEMT 
PAHPs to comply with the grievance and appeal requirements in subpart F 
of this part. A few commenters recommended that CMS reevaluate the new 
requirements proposed for NEMT PAHPs, as the new requirements will 
limit providers and drive up costs with little benefit to Medicaid 
enrollees.
    Response: We carefully considered the requirements for both NEMT 
PAHPs and PAHPs throughout part 438. We believe that the proposed list 
at Sec.  438.9(b) achieves the appropriate balance of enrollee 
protections and administrative efficiency for states and NEMT PAHPs. We 
maintain that an internal grievance and appeal system does not seem 
appropriate given the scope of NEMT PAHP contracts. Enrollees receiving 
services from NEMT PAHPs will continue to have direct access to the 
state fair hearing process to appeal adverse benefit determinations.
    Comment: A few commenters recommended that CMS include a 
requirement for audited financial reports at Sec.  438.9(b)(1).
    Response: We clarify for commenters that audited financial reports 
are included at Sec.  438.3(m) as a standard contract requirement. 
Section 438.9(b)(1) requires NEMT PAHPs to comply with all contract 
provisions in Sec.  438.3, including the audited financial reports at 
Sec.  438.3(m), except for the specific provisions in Sec.  438.3 
listed in Sec.  438.9(b)(1). For clarity, we will finalize paragraph 
(b)(1) with specific references to the provisions in Sec.  438.3 that 
do not apply to NEMT PAHP contracts.
    Comment: One commenter recommended that CMS clarify whether states 
must comply with the NEMT PAHP requirement at Sec.  438.9(b)(5) related 
to the state's responsibilities in Sec.  438.56 regarding 
disenrollment.
    Response: We clarify that Sec.  438.9(b)(5) related to the state's 
responsibilities in Sec.  438.56 regarding disenrollment would only 
apply to NEMT PAHPs if the state allows enrollee disenrollment from the 
NEMT PAHP. We note that consistent with section 1915(b)(4) of the Act, 
many states selectively contract with one NEMT PAHP, or broker, per 
geographic region and would not be required to comply with Sec.  
438.56.
    Comment: Some commenters recommended that Sec.  438.9(b) be amended 
to make the Indian specific provisions in Sec.  438.14 applicable to 
NEMT PAHPs.
    Response: We appreciate the commenters observation and have added 
the provisions of Sec.  438.14 to Sec.  438.9(b) in a new paragraph 
(b)(10).
    Comment: We received one comment recommending that NEMT PAHPs be 
added in proposed Sec.  438.818. The commenter believed that since NEMT 
PAHPs were included in proposed Sec.  438.242, they should also be 
included in proposed Sec.  438.818.
    Response: We agree and acknowledge that not including a reference 
to Sec.  438.818 in the proposed Sec.  438.9 was an oversight. Proposed 
Sec.  438.9(b)(5) has been revised accordingly.
    After consideration of the public comments, we are finalizing Sec.  
438.9 as proposed with the addition of specific references to Sec.  
438.3 in Sec.  438.9(b)(1), Sec.  438.818 in Sec.  438.9(b)(5), and the 
addition of the provisions of Sec.  438.14 in Sec.  438.9(b)(10).
h. State Plan Requirements (Sec.  438.50)
    Section 438.50 governs state plan requirements for programs with 
mandatory managed care enrollment and currently has a reference to 
``managed care entities.'' Although defined in the statute, ``managed 
care entities'' is an undefined term in the regulation. Because this 
provision only applies to MCOs and PCCMs as referenced later in Sec.  
438.50, we proposed to replace the term ``managed care entities'' with 
``MCOs, PCCMs, or PCCM entities, as applicable.''
    In addition, we proposed to delete paragraphs (e) and (f), which 
addressed priority and default enrollments for managed care programs 
operated under section 1932(a) of the Act. These processes, along with 
other general standards for enrollment, that are applicable to all 
authorities for managed care programs are provided in the proposed new 
Sec.  438.54.
    We received the following comments in response to our proposal to 
revise Sec.  438.50.
    Comment: One commenter recommended that CMS modify proposed Sec.  
438.50(b)(4), pertaining to the public process in both the design and 
implementation of a managed care program under section 1932(a) of the 
Act, to set specific standards to include the perspectives of families 
and, in particular, families of children with special health care 
needs. Specifically, the commenter stated that states should be 
required to consult with pediatricians, pediatric medical 
subspecialists, and pediatric surgical specialists in the public 
process when

[[Page 27737]]

such populations are covered under the managed care program.
    Response: We agree that states should engage with appropriate 
stakeholder groups for public input in the design, implementation, and 
on-going monitoring of their managed care programs, but to anticipate 
every appropriate stakeholder for the populations covered under a 
managed care program in regulation is not feasible. We encourage states 
to review the covered populations and benefits in their programs and 
ensure that their stakeholder engagement is sufficiently robust. We 
decline to revise this provision.
    Comment: One commenter requested clarification as to why CMS 
excluded PIHPs and PAHPs from proposed Sec.  438.50 and encouraged CMS 
to require that states not be allowed to require enrollment in PIHPs or 
PAHPs.
    Response: Section 438.50, as proposed and finalized here, 
implements section 1932(a) of the Act, which only addresses MCOs and 
PCCMs. PIHPs and PAHPs cannot be utilized for programs authorized using 
section 1932(a) authority. We clarify that Sec.  438.52 permits 
mandatory enrollment into PIHPs or PAHPs.
    Comment: We received one comment recommending that as non-MCO 
entities provide an increasing number of services comparable to MCOs, 
(for example, ACOs), CMS should require these entities to operate on a 
level playing field with existing market participants for requirements 
such as network requirements, actuarial soundness, solvency and 
reserves, and quality improvement. The commenter believes it helps 
reduce administrative barriers to ensure that families and individuals 
have the most seamless possible transition between coverage types.
    Response: We decline to revise this provision to address ACOs. We 
believe we have addressed this issue by including PCCM entities in 
Sec.  438.50 and many other sections of this rule. Additionally, we 
added PAHPs to many provisions of the regulation where the PAHPs had 
previously been excluded. We believe this creates a more consistent 
application of the provisions and increases transparency, 
accountability, and beneficiary protections. ACOs or other integrated 
care models that do not meet the definition of a MCO, PIHP, PAHP, PCCM, 
or PCCM entity is not governed by 42 CFR part 438.
    After consideration of the public comments, we are finalizing Sec.  
438.50 as proposed without modification.
7. Implementing Statutory Provisions
a. Encounter Data and Health Information Systems (Sec. Sec.  438.2, 
438.242 and 438.818)
    As explained in the proposed rule at I.B.7.a, sections 6402(c)(3) 
and 6504(b)(1) of the Affordable Care Act reorganize, amend, and add to 
sections 1903(i)(25) and 1903(m)(2)(A)(xi) of the Act by adding 
provisions related to routine reporting of encounter data as a 
condition for receiving federal matching payments for medical 
assistance. Section 1903(i)(25) of the Act mandates that, effective 
March 23, 2010, federal matching payments to the states must not be 
made for individuals for whom the state does not report enrollee 
encounter data to us. Further, section 1903(m)(2)(A)(xi) of the Act 
specifies that an MCO must report ``patient encounter data'' for 
contract years after January 1, 2010, to the state in a timeframe and 
level of detail specified by the Secretary. We noted in the proposed 
rule that the data that must be collected and reported under these 
provisions is the same, but the population of covered by section 
1903(i)(25) of the Act, compared to the population covered by section 
1903(m)(2)(A)(xi) of the Act, included enrollees of PIHPs and PAHPs.
    Since effective monitoring of all programs from which enrollees 
receive services is a critical function, we proposed to expand the 
contract standards that apply the provisions of section 
1903(m)(2)(A)(xi) of the Act to PIHPs and PAHPs by utilizing authority 
under section 1902(a)(4) of the Act to ensure the proper and efficient 
operation of the state plan by ensuring provision to the state of 
information that the state must provide to CMS.
    We proposed to add the following:
     A definition of enrollee encounter data in Sec.  438.2;
     Additional MCO, PIHP, and PAHP contract standards defining 
enrollee encounter data submission and maintenance standards;
     Clarifications to better align the basic elements of a 
health information system with the Affordable Care Act; and
     Standards on the state to report accurate, complete, and 
timely enrollee encounter data to us as a condition for receiving 
federal matching payments on its MCO, PIHP, and PAHP contract 
expenditures.
    In Sec.  438.2, we proposed to define enrollee encounter data as 
the information relating to the receipt of any item(s) or service(s) by 
an enrollee under a contract between a state and a MCO, PIHP, or PAHP 
that is subject to the standards of Sec. Sec.  438.242 and 438.818.
    We proposed to revise Sec.  438.242 to clarify and align the basic 
elements of a MCO, PIHP, or PAHP health information system with the 
Affordable Care Act. The size and scope of today's Medicaid programs 
need robust, timely, and accurate data to ensure the highest financial 
and program performance, support policy analyses, and maintain ongoing 
improvement that enables data-driven decision making. In August 2013, 
we released SMDL #13-004 that issued guidance to states on the 
Transformed Medicaid Statistical Information System (T-MSIS) http://www.medicaid.gov/Federal-Policy-Guidance/Downloads/SMD-13-004.pdf. We 
also indicated that we intended to review whether managed care entities 
provide timely and accurate encounter data to facilitate the transition 
to T-MSIS. Future guidance and revisions to the CMS EQR protocols will 
reflect this ongoing effort. In paragraph (a), we proposed, relying on 
section 1902(a)(4) of the Act, to include PAHPs in the existing 
requirement for managed care plans to maintain a health information 
system meeting certain standards. This aligns with our other proposals 
to extend existing standards throughout this part to PAHPs because the 
services they provide are important and they must be held as fully 
accountable as MCOs and PIHPs; enrollees of PAHPs must be afforded the 
same protections as MCO and PIHP enrollees. Additionally, we proposed 
to change the reference to having sufficient data to achieve the 
objectives of ``this subpart'' to ``this part'' to emphasize the 
critical role data plays in achieving the objectives throughout part 
438. We also proposed making this same change in paragraph (b)(4) 
(redesignated from (b)(3)).
    In Sec.  438.242(b)(1), we proposed a specific reference to the new 
standard in section 6504(a) of the Affordable Care Act, which would 
mandate that state claims processing and retrieval systems be able to 
submit data elements to us deemed necessary for Medicaid program 
integrity, oversight, and improvement. Existing paragraphs (b)(1) 
through (b)(3) were proposed to be redesignated, respectively, as 
paragraphs (b)(2) through (b)(4); in paragraph (b)(2), we also proposed 
to add ``all'' to clearly indicate that data collected by the state 
would have to include all services furnished to an enrollee. For 
similar reasons, we proposed to add ``including capitated providers'' 
in paragraph (b)(3)(i) as this is currently a data weakness for many 
states, MCOs, PIHPs, and PAHPs. Utilization data from capitated 
providers is frequently less

[[Page 27738]]

robust, or in some cases non-existent. This data is equally as 
important as the data from providers paid on a FFS basis and must be 
incorporated and utilized in all MCO, PIHP, and PAHP functions.
    We proposed a new Sec.  438.242(c) to add standards for enrollee 
encounter data that would have to be incorporated in all MCO, PIHP, and 
PAHP contracts. Contracts would have to specify that enrollee encounter 
data must: Include rendering provider information; include all 
information that the state is required to produce under Sec.  438.818; 
and be submitted to the state in a format consistent with the industry 
standard ASC X12N 835, ASC X12N 837, and NCPDP formatting. In paragraph 
(c)(2), we also proposed that MCOs, PIHPs, and PAHPs submit data at a 
level of detail to be specified by CMS. To retain flexibility to adapt 
to changes in coding and payment practices over time, we anticipate 
issuing guidance in the future. At a minimum, we expect the initial 
guidance to address standards for MCOs', PIHPs', and PAHPs' submissions 
to the state: Enrollee and provider identifying information; service, 
procedure and diagnosis codes; allowed/paid, enrollee responsibility, 
and third party liability amounts; and service, claim submission, 
adjudication, and payment dates.
    We proposed to add a new Sec.  438.818 entitled Enrollee Encounter 
Data to implement the standard for enrollee encounter data reporting by 
the state to CMS. We proposed that federal matching payments would not 
be available for states that do not meet established data submission 
benchmarks for accuracy, completeness, and timeliness. Timeliness and 
frequency of reporting encounter data is a key issue in terms of 
alignment between the managed care delivery system and the FFS Medicaid 
delivery system. We released guidance in 2013 \12\ that clarified the 
data elements, reporting structure for, and frequency of enrollee 
encounter data in the Medicaid Statistical Information System (MSIS). 
States must submit data monthly for all FFS and managed care services 
as required by section 1903(r) of the Act.
---------------------------------------------------------------------------

    \12\ http://www.medicaid.gov/Federal-Policy-Guidance/Downloads/SMD-13-004.pdf.
---------------------------------------------------------------------------

    In addition to receipt of data in a timely manner, we noted that 
receipt of data that is accurate and complete is integral to our 
administration and oversight of state Medicaid programs. This means 
that encounter data submitted to us must represent all services 
received by an enrollee regardless of payment methodology, including 
services sub-capitated by a MCO, PIHP, or PAHP to a provider. In 
proposed Sec.  438.818(a), we restated the statutory provision 
prohibiting FFP unless the state meets the standards for submitting 
sufficient and timely encounter data. Proposed paragraph (a)(1) would 
require that the submission of encounter data be compliant with current 
HIPAA security and privacy standards and in the format needed by the 
MSIS or any successor format. MSIS and T-MSIS are the repositories of 
all encounter data for the Medicaid program and although submission of 
data to MSIS has been a standard for years, states have not always 
invested the resources needed to ensure the quality of the submissions. 
We proposed these changes to support efforts currently underway to 
improve the accuracy, timeliness, and completeness of submissions. We 
proposed in paragraph (a)(2) that the state validate enrollee encounter 
data before each submission to us. States may use various methods to 
ensure the accuracy and completeness of the encounter data, including 
the protocol defining the optional EQR activity for Encounter Data 
Validation.\13\ We expect that if a state chooses a different method, 
it would ensure that there is sufficient analytic rigor in the chosen 
method.
---------------------------------------------------------------------------

    \13\ https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Quality-of-Care/Quality-of-Care-External-Quality-Review.html.
---------------------------------------------------------------------------

    We proposed Sec.  438.818(a)(3) to reinforce the importance of 
complying with all MSIS encounter data reporting standards as a 
condition for receipt of FFP and noted that encounter data is just one 
piece of a complete MSIS submission. To maximize our ability to fully 
integrate and utilize all MSIS data for comprehensive analysis and 
oversight, we emphasized that encounter data needs to be fully 
compliant.
    In Sec.  438.818(b) and (c), we proposed to review each encounter 
data submission for accuracy and potentially defer or disallow payment 
to a state if it is determined that the enrollee encounter data set is 
not complete, accurate, and timely. If, after review of an encounter 
data submission, we determine that it does not comply with established 
criteria, we proposed to provide the state with a reasonable 
opportunity to make the submission compliant. Further, if the state is 
unable to make the submission compliant within the time allowed, we 
proposed to defer and/or disallow FFP for the MCO, PIHP, or PAHP 
contract in question. We interpreted the statute as providing for a 
per-enrollee disallowance for a failure to report enrollee encounter 
data. We believe it is more accurate to calculate the deferral and/or 
disallowance amount based on the enrollee and the specific service type 
of the non-compliant data. Using this methodology, only the portion of 
the capitation payment attributable to that enrollee for the service 
type of the non-compliant data would be considered for deferral and/or 
disallowance under sections 1903(i)(25) and (m)(2)(A)(xi) of the Act. 
For example, if the non-compliant encounter data is for inpatient 
hospital services, then only the inpatient hospital portion of the 
capitation payment for that enrollee would be subject to deferral and/
or disallowance. We proposed that any reduction in FFP would be 
effectuated through the processes outlined in Sec.  430.40 and Sec.  
430.42. In Sec.  438.818(d), we proposed that within 90 calendar days 
of the effective date of the final regulation, states would have to 
submit to us a detailed plan of their procedures to ensure that 
complete and accurate data are being submitted timely. We indicated our 
intention to work with the states to develop a comprehensive and 
workable procedure and would review and approve the states' plans for 
compliance.
    We received the following comments in response to our proposal to 
revise Sec. Sec.  438.2, 438.242 and 438.818.
    Comment: Some commenters expressed support for proposed Sec.  
438.242. Commenters believed it added important detail on the 
responsibilities of the MCOs, PIHPs, and PAHPs to submit complete 
encounter data to the state.
    Response: We thank the commenters for their support.
    Comment: We received one comment requesting that proposed Sec.  
438.242(b)(2) be amended to include a requirement that a managed care 
plan's system be capable of collecting, reporting and analyzing data 
stratified by race, ethnicity, sex, primary language, gender identity, 
sexual orientation, geography and disability status.
    Response: Most of the data elements suggested by the commenter are 
not required to be provided by Medicaid applicants. Section 435.907(e) 
of this chapter provides that the state may only require information 
relevant to an eligibility determination. Section 438.242(c)(3) 
requires managed care plans to submit all of the data that the state is 
required to report to CMS under Sec.  438.818 and there are fields in 
TSIS for race, ethnicity, sex, and disability status, if supplied by 
the applicant. However, it is not appropriate to mandate submission of 
data elements that the state may not have a way to

[[Page 27739]]

collect unless volunteered by the applicant.
    Comment: One commenter requested that CMS add ``in all 
circumstances, without exception'' to ``Collection and maintenance of 
sufficient enrollee encounter data to identify the provider who 
delivers any item(s) or service(s) to enrollees'' as proposed in Sec.  
438.242(c)(1) to emphasize the importance of submitting the rendering 
provider data.
    Response: While we agree that submitting this data is required, we 
do not believe it is necessary to add additional emphasis to Sec.  
438.242(c)(1). We believe the proposed provisions in Sec.  438.242(c) 
are sufficiently clear to convey that all managed care plan contracts 
must provide for the submission of this data.
    Comment: A few commenters stated that data is not always available 
to managed care plans because providers do not supply it. The commenter 
stated that this issue is particularly acute with providers that are 
paid an all-inclusive or bundled rate and providers paid on a capitated 
basis.
    Response: We understand the commenters' concern, particularly for 
providers paid via capitation by the managed care plans; we added a 
specific reference to this in proposed Sec.  438.242(b)(3)(i). We do 
not have the ability to place requirements directly on providers in 
part 438. However, managed care plans have the ability to, and should, 
address the issue through their contracts with providers to ensure that 
the plan meets its obligations under the contract terms required by 
Sec.  438.242.
    Comment: A few commenters requested clarification on ``frequency 
and level of detail'' in proposed Sec.  438.242(c)(2). Some commenters 
requested that CMS specify the data elements required for encounter 
data submissions. One commenter suggested we include the five EPSDT 
screening elements, while another commenter suggested adding number of 
hours worked, travel time, and overtime for home care workers.
    Response: We thank the commenters for the opportunity to clarify 
this issue. Encounter data is critical for states to be able to 
effectively and efficiently operate their managed care programs and to 
report to CMS. The encounter data are the basis for any number of 
required or voluntary activities, including rate setting, risk 
adjustment, quality measurement, value-based purchasing, program 
integrity, and policy development. We have engaged in many efforts with 
states to improve the quality, timeliness, and use of encounter data. 
The data elements required in a state's submission to MSIS/T-MSIS are 
already defined and states are aware of the required elements. These 
data elements form the minimum requirement that States must collect 
from managed care plans under proposed Sec.  438.242(c)(3) to ensure 
compliance with Sec.  438.818.
    However, Sec.  438.242(c)(2) implements section 1903(m)(2)(a)(xi) 
of the Act, which we believe was intended to broadly support program 
integrity, program oversight, and administration before expending 
federal dollars. As proposed, Sec.  438.242(c)(2) did not include 
specific elements to ensure that we have the ability to respond 
appropriately to new and emerging program integrity concerns, new 
methods of fraud waste and abuse, and changing oversight concerns. We 
believe that this flexibility is particularly important as new, more 
complex and vulnerable populations transition to managed care and as 
more federal Medicaid funding is flowing through managed care programs.
    Additionally, we recognize that states need additional and 
different data elements, beyond the minimum required for submission 
under Sec.  438.818, for other program activities (for example, rate 
setting, risk adjustment, quality measurement, and value-based 
purchasing). To make the flexibility we intended clearer and to provide 
the parameters and substantive standards for identification of the 
frequency and level of detail for these information submissions, we 
will revise Sec.  438.242(c)(2) to state that this information must be 
specified by CMS and the state based on program administration, 
oversight and program integrity needs. For this reason, we decline to 
add a specific set of data elements to Sec.  438.242(c)(2).
    For EPSDT screenings, we are not aware of any reason why they would 
not be included in the encounter data submission to the state, if they 
are reported by the provider to the managed care plan. We note that 
there are no fields in T-MSIS for number of hours worked, travel time, 
and overtime for home care workers so the state would not be required 
to submit that data to MSIS/T-MSIS. Consequently, these data would not 
be covered by Sec.  438.242(c)(3). The managed care plan, by contract, 
may be required to submit that data to the state; managed care plans 
should consult their contract and the state to determine the reporting 
requirements for that information, if appropriate. We note that Sec.  
438.242, as finalized in this rule, imposes a minimum requirement that 
the state must include and ensure through its contracts with managed 
care plans; states may impose additional requirements to serve state 
needs.
    Comment: A few commenters suggested that CMS not require pricing 
information on encounter data, particularly when the provider is paid 
on a capitated basis.
    Response: We appreciate the complexity of attaching pricing 
information to encounters from capitated providers, but states need to 
work with their managed care plans to establish a methodology for 
consistent submission of these types of encounters. Encounters from 
capitated providers are too frequently not collected by states despite 
the fact that they often represent a high volume of services rendered. 
Including the paid amount on encounter data provides important 
information to the state and CMS and enables multiple types of useful 
analysis not previously available. Additionally, this information is 
increasingly more important as CMS and states apply more data-driven, 
analytic methods to value-based purchasing efforts and rate 
development. Per service pricing information may not be available when 
providers are paid on a capitated basis but at least the amount of the 
capitation payment should be available.
    Comment: One commenter suggested that states share the required 
data elements and validation process for encounter data with managed 
care plans and their subcontractors so they can ensure that the data 
they submit will meet the requirements.
    Response: We agree that sharing information on the state's 
validation activities could be helpful and encourage states and managed 
care plans to collaborate on the most effective way to disseminate the 
information.
    Comment: One commenter suggested that states be able to use a 
proprietary file format if the ASC 12N X835 did not supply sufficient 
information to managed care plans on the state's adjudication of 
encounter data.
    Response: We thank the commenters for the opportunity to clarify 
the requirements in Sec.  438.242(c)(4). We believe that the accuracy, 
timeliness, and consistency of encounter data will improve, if states 
and managed care plans use standards that have been developed and are 
maintained by Standard Setting Organizations (as defined at 45 CFR 
160.103). The use of common standards for the submission of an 
encounter also facilitates the development of guidance and third party 
tools to support the submission, processing and auditing of encounter 
data. We also believe that the accuracy,

[[Page 27740]]

timeliness, consistency, and efficiency of encounter data submissions 
can be best achieved by linking the requirements to similar 
requirements on providers and managed care plans for routine business 
transactions, such as electronic claim submission and electronic 
remittance advice.
    The standards identified in Sec.  438.242(c)(4) have been developed 
and are maintained through Standards Setting Organizations. We would 
also note that there has been significant work to make these standards 
applicable to encounter data reporting. The ANSI ASC X12 has 
specifically developed the Post Adjudicated Claims Data Reporting 
standard for purposes of reporting encounter data. These standards were 
developed with broad support from the payer and provider community. 
Additionally, many states have modified definitions of data elements in 
the ASC X12N 837 standard while maintaining the formatting for purposes 
of submitting encounter data. This approach has allowed states to 
collect all necessary claim and remittance data from managed care 
plans. Although we believe that using a single standard such as the 
Post Adjudicated Claims Data Reporting is preferable, using the general 
formats identified in Sec.  438.242(c)(4) will facilitate managed care 
plans and states moving toward greater standardization.
    Managed care plans, providers, and states are required to use the 
HIPAA compliant versions of the standards identified in Sec.  
438.242(c)(4) for routine electronic business transactions. Because the 
standards are used for routine and necessary business transactions, the 
standard code sets needed to make the standards workable are also 
routinely updated. We believe that the more closely the encounter data 
requirements align with other existing business transactions, the 
easier it will be to collect high-quality encounter data.
    We take this opportunity to clarify that Sec.  438.242(c)(4) 
requires the use of a standard format. It does not require the use of a 
specific transaction (for example, a HIPAA compliant Health care claims 
or equivalent encounter information transaction). If states are using 
the standard format and modifying the definitions of particular data 
elements within the format, CMS would find this consistent with the 
requirements in Sec.  438.242(c)(4). Many states have been able to use 
the standard formats to collect adjudicated data, therefore we decline 
to allow the use of proprietary formats.
    Comment: Many commenters recommended that CMS supply standardized 
formats for encounter data submissions to the state and to CMS. We 
received one comment suggesting that CMS require managed care plans' 
network providers to also submit additional information using the ASC 
12N X275 format (Additional Information to Support a Health Care Claim 
or Encounter).
    Response: We proposed, and finalized in this rule, specific 
standardized formats for managed care plans to use in proposed Sec.  
438.242(c)(4). We believe that the development and maintenance of the 
standard formats would be best accomplished through an appropriate 
Standard Setting Organization with the broad input of all impacted 
parties. The use of a Standard Setting Organization would also allow 
for the development of standards that would be applicable to a wider 
set of plan business needs beyond Medicaid. The standardized formats 
required for states to submit encounter data to CMS is dictated by 
MSIS/T-MSIS and has been repeatedly communicated to states. We 
encourage managed care plans and providers to use standard, electronic 
transaction to the greatest extent possible. However, dictating the use 
of particular electronic business transactions between managed care 
plans and providers is outside the scope of this regulation.
    Comment: We received some comments expressing support for proposed 
Sec.  438.818. Commenters believed it added important detail on the 
responsibilities of the state to supply high quality data to CMS.
    Response: We thank the commenters for their support of Sec.  
438.818.
    Comment: Several commenters recommended that states make encounter 
data available to stakeholder groups, advisory groups, and the public.
    Response: We are not finalizing a requirement for encounter data to 
be made public. While we proposed in Sec.  438.602(g)(2) that states 
would make all data submitted under proposed Sec.  438.604, including 
encounter data, available upon request or on the state's Web site, we 
have decided not to require that encounter data be made publicly 
available in the final rule. After consideration of comments received 
on the proposed provisions of Sec.  438.602(g)(2), we believe that the 
proposed rule was overly broad in the types of information that would 
need to be on the state's Web site or made available upon request. We 
are finalizing section Sec.  438.602(g) specifying the minimum list of 
the types of information to be made publicly available on the state's 
Web site and are not specifying information that must be available upon 
request.
    Comment: Some commenters recommended that CMS provide more 
resources and/or funding to states to implement the proposed provisions 
in Sec.  438.818. Commenters believed the provisions would require a 
significant amount of resources and expertise that some states will 
have problems accessing.
    Response: We understand the commenter's concerns; however, the 
proposed provisions in Sec.  438.818 are not substantially new in terms 
of state responsibility. Section 4753 of the Balanced Budget Act of 
1997, adding section 1903(r) of the Act, required states to have 
mechanized information retrieval systems that provided for electronic 
transmission of encounter data consistent with MSIS. Proposed Sec.  
438.818 simply adds provisions for implementing section 1903(i)(25) of 
the Act. We have been providing technical assistance to states on 
encounter data submission to MSIS/T-MSIS for many years. Despite this, 
some states have not or could not make the investment of resources 
previously to comply with MSIS/T-MSIS requirements; as proposed and 
finalized, Sec.  438.818 will require them to make that investment. We 
are obligated to implement the statutory requirements in section 
1903(i)(25) of the Act to condition FFP on the provision of this data 
by the state; we believe that states' administration of their managed 
care programs will benefit in numerous ways from receiving more timely, 
accurate, and complete encounter data.
    Comment: One commenter noted that as managed care plan contracting 
moves to a more value-based approach, one incentive for providers to 
participate is to limit the amount of reporting and submissions. The 
commenter recommended that CMS engage with states and managed care 
plans about the tension between encounter data submission and value-
based purchasing.
    Response: We assume that these comments are applicable to both 
Sec. Sec.  438.242 and 438.818 Value-based purchasing, which is 
frequently focused on outcomes, may require additional alternative 
types of data and the use of different methods to document the 
provision of services and evaluate the quality of services. In many 
circumstances, value-based purchasing has required more extensive data 
exchanges between providers and managed care plans to ensure the 
distribution of adequate information about an enrollee's care. Value-
based purchasing may, overtime, require the health care community to 
develop different methods and systems for documenting the provision of 
services

[[Page 27741]]

than the claims-based approach used today. We will work with 
stakeholders to monitor the information needs associated with value-
based purchasing; however, the predominant method for documenting the 
provision of health care services today is the use of claims data. We 
note that Sec.  438.242(c)(2) permits changes in the frequency and 
level of data when necessary for program administration, oversight and 
program integrity, not necessarily to support transitions to different 
purchasing models if data other than encounter data is collected. 
States that transition to other purchasing models should be careful to 
assure that their contracts with managed care plans support the states' 
needs for data.
    Comment: One commenter suggested that any assessment of 
``sufficient and timely'' encounter data as proposed in Sec.  
438.818(a) should also provide consideration for value based purchasing 
initiatives and how states can document expenditures for value and 
outcomes that may not be captured in encounter data.
    Response: We understand the commenter's concern and agree that 
certain outcomes, particularly a reduction in undesirable services (for 
example, readmissions), may not be readily apparent in encounter data. 
However, we believe that complete encounter data can demonstrate these 
improvements through analysis, making compliance with the proposed 
provisions even more critical. Better, more complex, analysis requires 
more complete, timely, and accurate data.
    Comment: One commenter stated that burdensome reporting 
requirements could cause some health care providers to not contract 
with managed care plans and affect network adequacy.
    Response: We are unclear why the commenter believes the proposed 
requirements in either Sec. Sec.  438.242 or 438.818 would pose an 
unreasonable burden on providers. The data required is no more than 
required on a claim in a standardized format, which most other health 
insurance issuers require for all product lines. We acknowledge that 
there is more variation in billing practices for LTSS providers, but 
many states with managed LTSS programs have developed policies to 
address consistent code sets and standards for their use.
    Comment: We received several comments requesting clarification of 
terms used in proposed Sec.  438.818. Commenters questioned the meaning 
of ``validate'' and ``completeness'' in proposed Sec.  438.818(a)(2).
    Response: We thank the commenter for the opportunity to clarify 
this requirement. The requirement in in Sec.  438.818(a)(2) was 
intended to capture two different types of validation. First, it was 
intended to require states to review and confirm that the information 
that the state received from managed care plans under Sec.  438.242(c) 
was complete and accurate. That is, the encounter data supplied to the 
state under Sec.  438.242(c) was a true representation of the encounter 
data held by the managed care plan after the adjudication of all 
providers claims, for all services, for all enrollees under the managed 
care plan's contract with the state. We agree that this validation 
requirement could be clearer and we are finalizing a new paragraph 
Sec.  438.242(d), which states the State shall review and validate that 
the encounter data collected, maintained, and submitted to the State by 
the MCO, PIHP, or PAHP, meets the requirements of this section. The 
State shall have procedures and quality assurance protocols to ensure 
that enrollee encounter data submitted under paragraph (c) is a 
complete and accurate representation of the services provided to the 
enrollees under the contract between the State and the MCO, PIHP, or 
PAHP.
    The second type of validation intended under Sec.  438.818(a)(2) 
was to require states to validate the data to CMS through MSIS/T-MSIS 
as complete and accurate. Submission of encounter data by managed care 
plans to the state consistent with the requirements in Sec.  438.242 
enables the state to submit data to CMS that is complete and accurate; 
under these regulations, states are responsible for reviewing the data 
and making sure that the regulation standards are met before submitting 
the data to CMS. Section 438.818 also requires that states submit all 
of the data elements required by MSIS/T-MSIS, for all of the services, 
for all of the enrollees enrolled in the states' managed care plans. We 
will clarify these requirements by modifying Sec.  438.818(a)(2) to 
state that states must ensure that enrollee encounter data is validated 
for accuracy and completeness as required under Sec.  438.242 before 
submitting data to CMS. States shall also validate that the data 
submitted to CMS is a complete and accurate representation of the 
information submitted to the State by the MCOs, PIHPs, or PAHPs.
    In finalizing Sec.  438.242(d) and Sec.  438.818(a)(2), we 
eliminated the text, ``States may use the EQR activity required in 
Sec.  438.358 for the validation of encounter data to meet this 
requirement.'' We eliminated this language for two reasons. First, the 
validation of encounter data is an optional activity under Sec.  
438.358 and it is not a required activity. Second, the use of an EQR to 
validate the encounter data reported by a managed care plan can be an 
important component of states' procedures and quality assurance 
protocols to ensure that enrollee encounter data submitted is a 
complete and accurate representation of the services. However, an 
annual validation alone is probably not adequate. Many states have been 
developing procedures and protocols to ensure that their data is 
complete and accurate, including evaluating the value of submitted 
claims against the managed care plan's general ledger, random sampling 
of claims within managed care plans' systems, and other types of 
reconciliation. States have found that performing validation activity 
on a monthly or quarterly basis has improved the data collection 
efforts. We support and encourage states' efforts to improve encounter 
data. CMS anticipates continuing to work with states and to publish 
guidance and best practices based on states' experiences.
    Comment: We received several comments requesting clarification of 
other terms used in proposed Sec.  438.818. Commenters questioned the 
meaning of ``fully comply'' in proposed Sec.  438.818(a)(3), 
``compliance issues'' in Sec.  438.818(c) and ``reasonable 
opportunity'' as used in the preamble for Sec.  438.818(c).
    Response: We do not intend a unique meaning to ``fully comply'' in 
proposed Sec.  438.818(a)(3) with the caveat that we acknowledge that 
states are currently in varying stages of compliance with MSIS/T-MSIS 
requirements and are working with CMS to document any deficiencies. For 
those states, ``fully'' will be considered to be within the parameters 
approved by CMS at the time of submission. ``Reasonable opportunity'' 
was used in the preamble in reference to proposed Sec.  438.818(c) 
where we proposed, if, after review of an encounter data submission, we 
determine that it does not comply with established criteria, we propose 
to provide the State with a reasonable opportunity to make the 
submission compliant. States currently receive feedback from CMS on 
their MSIS/T-MSIS submissions and are expected to correct any noted 
deficiencies and resubmit corrected data. As the final rule is 
implemented, additional guidance will be provided clarifying additional 
details. ``Compliance issues'' simply refers back to Sec.  438.818(b) 
which states CMS will assess a State's submission to determine if it 
complies with current criteria for accuracy and completeness; 
``compliance issues'' would be anything that causes us to

[[Page 27742]]

determine that the submission is not compliant with current criteria 
for accuracy and completeness.
    Comment: We received a few comments raising the issue of the 
expense of data validation. Commenters believed that CMS should provide 
additional funding to states for validation activities; allow the 
enhanced FFP rate of 75 percent apply to any vendor that performs data 
validation; and allow managed care plans to have policies and 
procedures for ensuring accuracy and completeness and only require that 
EQROs review those policies and procedures.
    Response: We understand the commenters' concerns regarding the 
expense of data validation. However, we believe that States should 
generally already be taking steps to ensure the accuracy and 
completeness of encounter data. The ability to collect accurate, 
timely, and complete encounter data is critical to the effective 
operation of a managed care program. We are aware that many states have 
been devoting resources and efforts to improve their data collection 
efforts. CMS supports these efforts and is available for technical 
assistance. We acknowledge that the validation processes used by states 
need to accommodate the monthly submission schedule for T-MSIS. Given 
that MSIS/T-MSIS submissions are subject to deferral or disallowance of 
FFP under section 1903 of the Act, we do not believe that a policy 
review alone is sufficient. The enhanced FFP rate of 75 percent in 
section 1903(a)(3)(C)(ii) of the Act is only designated for work 
performed by an EQR in reviewing MCO performance (see Sec.  438.370). 
We do not have the authority to extend that provision to other entity.
    Comment: We received one comment requesting clarification on 
whether the validation for accuracy and completeness had to be 
performed by an entity outside of the state Medicaid agency.
    Response: It was not our intent to imply that the validation for 
accuracy and completeness under Sec.  438.242(d) and Sec.  438.818 had 
to be done outside of the state Medicaid agency. States can perform 
their own data validation for accuracy and completeness if they choose.
    Comment: We received some comments requesting that CMS specify the 
standards states should use to determine accuracy and completeness of 
encounter data. One commenter recommended that CMS work with states to 
determine mutually agreeable standards. One commenter believed that 
standards for accuracy and completeness should be customized by state 
to account for programmatic differences. One commenter requested 
clarification on whether the three tiers of edits applied by T-MSIS 
would meet CMS' expectations for quality, accuracy, and completeness.
    Response: We understand the commenters' request for more 
specificity on this important provision. However, we do not believe CMS 
should set specific standards for accuracy and completeness under Sec.  
438.242(d).We believe states understand the importance of encounter 
data and will set sufficiently stringent standards under Sec.  
438.242(d) to complete successful MSIS/T-MSIS submissions, as well as 
to fulfill other programmatic data needs. For MSIS/T-MSIS submissions, 
deferrals and/or disallowances will be based on the results of 
evaluative processes to assess timeliness, accuracy, and completeness 
including but not limited to system edits. If it is determined that 
additional guidance on the evaluative processes or edits is needed 
after the release of this final rule, we will provide it.
    Comment: We received one comment requesting that CMS prohibit 
states from applying FFS claims edits to encounter data and to require 
states to report how many encounter records they deny based on those 
edits.
    Response: We understand the commenter's concern and agree that some 
FFS claims edits may not be appropriate to apply to encounter data and 
encourage states to review the edits that it applies to encounter data 
to ensure that they are appropriate. However, we decline to add that 
level of specificity to Sec.  438.242 or require denial rate reporting 
in Sec.  438.818.
    Comments: We received many comments suggesting the amount of time 
states and managed care plans will need to comply with proposed 
Sec. Sec.  438.242 and 438.818. Suggestion ranged from 1 to 5 years, 
while other commenters recommended a ``phased in'' approach.
    Response: We understand the commenters' concerns but maintain that 
states have historically been required to collect encounter data under 
Sec.  438.242. This final rule provides greater detail and 
clarification on this requirement. Similarly, we believe that 
sufficient time has been allowed for states to come into compliance 
with MSIS/T-MSIS submissions. States have been working with us to 
comply with TMSIS requirements utilizing established design and testing 
processes. As such, we acknowledge that the submission of an 
implementation plan by the state as proposed in Sec.  438.818(d) may 
not be a productive mechanism given states' current progress in 
achieving milestones toward full production status. To date, some 
states have completed sufficient testing and have already moved into 
the production phase of TMSIS submissions. Therefore, to help states 
keep their IT resources focused on full TMSIS compliance and eliminate 
unnecessary burden, we will not finalize Sec.  438.818(d) and, instead, 
continue to utilize established processes.
    Comment: We received several comments on the difficulty of 
collecting encounter data on LTSS due to the lack of standardized 
coding. Some commenters recommended that CMS create codes for states to 
use while others suggested that states be exempt from proposed 
Sec. Sec.  438.242 and 438.818 for MLTSS programs. One commenter 
recommended that states have flexibility in how they are required to 
submit data for non-state plan services and services that are more 
administrative. The commenter believed data on those types of services 
are dissimilar enough to the traditional types of encounter data 
reported that additional flexibility was warranted.
    Response: We understand there are some challenges with standardized 
coding for certain services, particularly for LTSS. However, we do not 
create billing codes; rather, we endorse the use of industry 
established codes, which we believe exist for the majority of covered 
services. Additionally, T-MSIS allows for each state to maintain a list 
of non-standard codes used in their data; codes submitted and on the 
state's approved list will not generate an error when submitted to T-
MSIS. We do not believe that exempting states with MLTSS plans from 
submitting any encounter data is an appropriate solution. The 
requirements in Sec.  438.242, as proposed and finalized here, provide 
states the flexibility to work with managed care plans and providers of 
LTSS services to ensure that claims submitted to managed care plans and 
encounter data submitted to the state meets the needs of the program. 
States need to understand the types of services and amount of services 
provided to individuals receiving LTSS, just as with any other Medicaid 
service. The text in Sec.  438.242 provides states the ability to 
collect the data consistent with their needs. Therefore, we decline to 
make the recommended modifications.
    Comment: We received numerous comments on requesting clarification 
on ``sufficient and timely'' in proposed Sec.  438.818(a). Some 
commenters suggested that states should be able to define it for 
themselves while many

[[Page 27743]]

commenters stated that the expectation should never be for 100 percent 
compliance.
    Response: We do not believe it would be appropriate for each state 
to set its own standard for submission of encounter data. We believe 
since all encounter data submitted by states is stored in MSIS/T-MSIS, 
it is more appropriate that the criteria be consistent to the extent 
possible. States will be notified as additional implementation details 
become available. To avoid ambiguity and clarify our intent, we will 
remove ``sufficient and timely;'' we do not want imply that our goal 
for T-MSIS is less than 100% compliance or that timeliness is the only 
criteria for encounter data.
    Comment: A few commenters requested clarification on the process 
that CMS will use for submission and review of encounter data under 
Sec.  438.818.
    Response: The processes for submission and review of encounter data 
under Sec.  438.818 are already established in the procedures for MSIS/
T-MSIS. We did not intend to imply there would be separate or different 
processes as result of this rule. If there are changes in MSIS/T-MSIS 
procedures, states will be notified.
    Comment: We received several comments on the challenges that states 
face in submitting data to MSIS, such as changing data dictionary 
values and formats. Commenters believe that CMS should not assume that 
having problems completing a successful MSIS submission indicates poor 
quality encounter data. Some commenters also believed that any 
deferrals or disallowances should be based on the actual quality of the 
data, not the state's ability to complete a successful MSIS submission.
    Response: We understand the commenters' concerns. We agree that 
states' effort to collect complete and accurate data from managed care 
plans is distinct from their MSIS/T-MSIS submissions. However, we are 
limited in our ability to accept and/or evaluate encounter data outside 
of MSIS/T-MSIS. We acknowledge that challenges exist in submitting to 
MSIS/T-MSIS and we continue to utilize states' experiences to determine 
needed enhancements to these systems. Additional details of the 
deferral and disallowance processes will be shared with states as they 
become available.
    Comment: We received one comment suggesting that submission of 
encounter data not be required more frequently than quarterly.
    Response: We do not agree that a revision of that nature is 
appropriate for either Sec.  438.242 or Sec.  438.818. As states 
operate their managed care program and pursue delivery system reforms, 
timely and accurate data is increasingly critical. Thorough and useful 
program monitoring should utilize the most current data available. As 
such, we believe a monthly schedule for T-MSIS, as currently exists, is 
appropriate. We also believe that most states are already collecting 
encounter data from managed care plans monthly or more frequently.
    Comment: We received one comment recommending that CMS rely on 
financial analysis rather than encounter data.
    Response: We do not agree with the commenter that financial 
analysis alone is sufficient. We acknowledge that financial analysis is 
an excellent tool for evaluating encounter data and encourage all 
states to utilize it, but we do not consider it a suitable replacement 
for the submission of encounter data.
    Comment: We received one comment requesting that CMS provide 
greater clarity on when deferral is appropriate, when a disallowance is 
appropriate, and when either may be appropriate as they are applied in 
proposed Sec.  438.818(c).
    Response: A reduction in FFP warranted by a state's failure to 
comply with Sec.  438.818 would be effectuated through the processes 
outlined in Sec.  430.40 and Sec.  430.42 and we are finalizing Sec.  
438.818(c) with additional language to make that clear. Additional 
details on the specific standards to be used to determine the necessity 
for a deferral or disallowance will be provided through sub-regulatory 
guidance.
    Comment: We received several comments recommending that any measure 
of accuracy and completeness by CMS as proposed in Sec.  438.818(b) be 
done at the aggregate level only, not at the individual record level. 
Commenters believed that CMS must recognize some of the inherent 
challenges with encounter data that will be unique to certain programs, 
such as MLTSS.
    Response: We do not agree that evaluation should be done only at 
the aggregate level. We acknowledge the challenges in collecting 
certain types of data consistently, particularly in MLTSS programs, but 
believe that analysis at the individual record level is the most 
appropriate and necessary to fulfill statutory intent in section 
1903(i)(25) of the Act, which provides that payment of FFP shall not be 
made with respect to any amounts expended for medical assistance for 
individuals for whom the State does not report enrollee encounter data 
(as defined by the Secretary) to the MSIS in a timely manner (as 
determined by the Secretary). This requirement also applies to payments 
for assistance for beneficiaries in Medicaid FFS and enrollees in a 
Medicaid managed care plan.
    Comment: We received many comments on the deferrals and 
disallowances provisions proposed in Sec.  438.818(c). Some commenters 
suggested that CMS should delay imposing a deferral and/or disallowance 
for a specified period of time; suggestions ranged from 2-5 years. A 
few commenters suggested removing proposed Sec.  438.818(c) completely; 
others suggested replacing it with CMS providing additional technical 
assistance for non-compliant submissions; and one commenter suggested 
that deferrals and disallowances not be taken if the enrollee did not 
receive any services. One commenter believed that payment should not be 
retracted from the managed care plans when a deferral and/or 
disallowance are taken as a result of an error by the state.
    Response: We appreciate the comments received on this important 
provision and remind commenters that this provision was added to 
implement section 1903(i)(25) of the Act. We understand the 
significance of this provision and states will be provided adequate 
advance notification as more details of the implementation process 
become available. To the comment regarding enrollees that have not 
received services, and thus, have no encounter data to report, it was 
never our intent to penalize a state for not submitting data that does 
not exist due to the enrollee not receiving services. Processes to 
accommodate this will be addressed in the implementation process. The 
retraction of capitation to a managed care plan as a result of a 
deferral and/or disallowance of FFP is outside the scope of this rule 
and should be addressed by the state in its managed care plan 
contracts.
    Comment: We received one comment recommending that CMS specify the 
standards and processes it will utilize to determine deferrals and 
disallowances so that the information can be added to the managed care 
plans' contract.
    Response: States will be provided adequate advance notification as 
more details of the implementation process become available. States are 
free to include the information in their managed care plan contracts as 
they deem appropriate.
    After consideration of the public comments, we are adopting 
Sec. Sec.  438.242 and 438.818 as proposed, with the

[[Page 27744]]

following changes. In Sec.  438.242(b)(4), we removed ``as required in 
this part'' to make our intention clearer that all collected data must 
be available to the state and CMS. In Sec.  438.242(c)(2), text was 
added to clarify and establish the standards and parameters for 
identifying the frequency and level of data. In Sec.  438.242(d), we 
are finalizing different regulation text to require state review and 
validation of all collected encounter data. In Sec.  438.818(a)(2), we 
are finalizing different regulation text to clarify that the validation 
required in Sec.  438.242(d) must be completed before the data is 
submitted to CMS and that states must validate that the data submitted 
to CMS is a complete and accurate representation of the data submitted 
to the state. In Sec.  438.818(c), clarifying language addressing 
deferrals and disallowances was added. The proposed text in Sec.  
438.818(d) is not being finalized, as explained above.
b. Standards for Contracts Involving Indians, Indian Health Care 
Providers and Indian Managed Care Entities (Sec.  438.14)
    This section implements section 5006(d) of the American 
Reinvestment and Recovery Act of 2009, which created section 1932(h) of 
the Act governing the treatment of Indians, Indian health care 
providers and Indian managed care entities, participating in Medicaid 
managed care programs. We had previously provided guidance on this 
statutory provision in a SMDL on January 22, 2010 (SMDL #10-001, ARRA 
#6) http://www.medicaid.gov/Federal-Policy-Guidance/downloads/SMD10001.PDF. To ensure the proper and efficient operation of the state 
plan, we proposed to expand the standards that apply the provisions of 
section 1932(h) of the Act to PIHPs and PAHPs through the authority 
under section 1902(a)(4) of the Act.
    We proposed in paragraph (a) to define the following terms: 
``Indian,'' ``Indian health care provider (IHCP),'' and ``Indian 
managed care entity (IMCE)'' consistent with statutory and existing 
regulatory definitions with minor modifications to extend the 
definitions, as applicable, to PIHPs and PAHPs.
    In paragraph (b), we proposed that each MCO, PIHP, PAHP, PCCM, and 
PCCM entity's contract had to comply with the provisions of (b)(1) 
through (5):
     In (b)(1), we proposed that each MCO, PIHP, PAHP, and PCCM 
entity's contract must demonstrate sufficient IHCPs in the managed care 
network and that Indian enrollees be able to obtain services from them;
     In (b)(2), we proposed that IHCPs be paid for covered 
services provided to Indian enrollees who are eligible to receive 
services from such providers whether the IHCP participates in the 
managed care network or not;
     In (b)(3), we proposed to permit any Indian who is 
enrolled in a non-Indian MCO, PIHP, PAHP, PCCM, or PCCM entity and 
eligible to receive services from a participating IHCP to choose that 
IHCP as his or her primary care provider, as long as that provider has 
capacity to provide the services;
     In (b)(4), we proposed to permit Indian enrollees to 
obtain services covered under the MCO's, PIHP's, PAHP's, or PCCM 
entity's contract, from out-of-network IHCPs; and
     In (b)(5), we proposed that in any state where timely 
access to covered services cannot be ensured due to few or no IHCPs, a 
MCO, PIHP, PAHP, and PCCM would be considered to have met the standard 
for adequacy of IHCP providers if either Indian enrollees are permitted 
to access out-of-state IHCPs, or the state deems the lack of IHCP 
providers to justify good cause for an Indian's disenrollment from both 
the MCO, PIHP, PAHP, or PCCM entity and the state's managed care 
program in accordance with Sec.  438.56(c).
    Proposed Sec.  438.14(c) outlined payment standards to implement 
section 1932(h) of the Act. Paragraph (c)(1) specified that when an 
IHCP is enrolled in Medicaid as a FQHC but is not a participating 
provider with a MCO, PIHP, PAHP, or PCCM entity, it must be paid FQHC 
payment rates, including any supplemental payment due from the state. 
Where the IHCPs is not enrolled in Medicaid as a FQHC, paragraph (c)(2) 
would have the MCO, PIHP, PAHP, or PCCM entity payment be the same 
payment as it would receive using a FFS payment methodology under the 
state plan or the applicable encounter rate published annually in the 
Federal Register by the Indian Health Service, regardless of its 
contracting status with the MCO, PIHP or PAHP. Paragraph (c)(3) 
proposed that when the amount a IHCP receives is less than the amount 
required in paragraph (c)(2), the state must make a supplemental 
payment to the IHCP to make up the difference between the amount paid 
by the managed care plan and the amount required in paragraph (c)(2).
    Paragraph (d) would implement the statutory provision permitting an 
IMCE to restrict its enrollment to Indians in the same manner as Indian 
Health Programs may restrict the delivery of services to Indians, 
without being in violation of the standards in Sec.  438.3(d).
    This proposed rule has tribal implications and is therefore, 
subject to the CMS Tribal Consultation Policy (December 2015) http://www.cms.gov/Outreach-and-Education/American-Indian-Alaska-Native/AIAN/Downloads/CMSTribalconsultationpolicy2015.pdf. Consistent with this 
policy, after the proposed rule was published on June 1, 2015, CMS 
issued a Dear Tribal Leader Letter soliciting advice and input from 
tribes and held a second All Tribes Call on June 25 to present an 
overview of the rule and the tribal specific provisions. On July 15, 
2015, CMS attended the Tribal Technical Advisory Group meeting to 
discuss the proposed rule provisions and solicit tribal advice and 
input.
    We solicited comment on the overall approach to this provision, 
including as to whether these proposals are adequate to ensure that 
Indian enrollees have timely and integrated access to covered services 
consistent with section 5006 of the ARRA. We solicited comment on how 
to facilitate a coordinated approach for care for Indian enrollees who 
receive services from a non-participating IHCP and who need Medicaid 
covered services through a referral to a specialty provider. Also, we 
solicited comment on the potential barriers to contracting with managed 
care plans for IHCPs and what technical assistance and resources should 
be made available to states, managed care plans, and IHCPs to 
facilitate these relationships.
    We received the following comments in response to our proposal to 
revise Sec.  438.14.
    Comment: A few commenters expressed concern that meaningful tribal 
consultation had not occurred given that the proposed rule has tribal 
implications and is subject to the CMS Tribal Consultation Policy. 
Commenters believed that it was critical that CMS work directly with 
the TTAG and other tribal entities to ensure that the final rule 
reflects suggestions received through that engagement about minimizing 
any disruption to services for individual AI/ANs or tribes as a whole. 
Commenters believed the All Tribes' Calls conducted prior to release of 
the proposed rule did not constitute acceptable tribal consultation, 
particularly for a proposed rule that affects tribal interests. 
Commenters recommended that CMS should ensure that the tribal community 
be given further opportunity to consult, review, and respond to 
provisions in the proposed rule before publication of the final rule.
    Response: We complied with its Tribal Consultation Policy (Policy) 
in

[[Page 27745]]

the development of this proposed rule. We held an All Tribes' Call on 
May 7, 2014, prior to development of the proposed rule to obtain advice 
and input on Tribal issues surrounding Medicaid managed care, 
consistent with the Policy. In an effort to preserve the federal 
government's deliberative process privilege, however, CMS does not 
consult with outside parties, including tribes, on the specifics of a 
proposed rule. Nevertheless, prior to the publication of the proposed 
rule, CMS staff attended the February 2015 TTAG face-to-face meeting to 
solicit advice and input on Medicaid managed care issues in general and 
to understand the tribal implications. After the proposed rule was 
published on June 1, 2015, CMS issued a Dear Tribal Leader Letter 
soliciting advice and input from tribes and held a second All Tribes 
Call on June 25, 2015, to present an overview of the rule and the 
tribal specific provisions. We considered the tribal comments that were 
submitted to the proposed rule consistent with the process identified 
in the proposed rule in the Federal Register (80 FR 31098). The All 
Tribes Calls were intended to provide information and answer questions 
to facilitate the formal submission of comments to the proposed rule. 
In addition, on July 15, 2015, we attended the TTAG meeting to discuss 
the proposed rule provisions and solicit tribal advice and input.
    Comment: Several commenters requested that CMS clarify that section 
1932(a)(2)(C) of the Act (adding section 1932(h) of the Act), which 
does not permit mandatory enrollment of Indians in a managed care 
program, cannot be waived through a section 1915(b) or 1115(a) 
demonstration waiver. The Balanced Budget Act (BBA) of 1997 allowed 
states to impose mandatory managed care programs through a State plan 
amendment, but Congress specifically prohibited states from mandating 
Indians into managed care through section 1932(a)(2)(C) of the Act. 
Commenters believed that CMS has interpreted the Indian managed care 
protections in section 1932(a)(2)(C) of the Act too narrowly by 
applying them only to managed care programs authorized under section 
1932(a) of the Act. The commenters believe that interpretation in not 
consistent with Congressional intent, which they believe was to exclude 
Indians from mandatory enrollment into managed care under all 
authorities. Other commenters were supportive of CMS' past practice of 
not permitting mandatory enrollment of Indians into managed care under 
section 1115(a) demonstrations and referred to that practice as not 
permitting a waiver of section 1932(a)(2)(C) of the Act.
    Response: We appreciate the opportunity to clarify the scope of 
section 1932(a)(2)(C) of the Act pertaining to enrollment of Indians 
into Medicaid managed care programs and the relation of that provision 
to other authorities for Medicaid managed care programs. Section 
1932(a)(1) of the Act provides the ability for states to operate a 
mandatory Medicaid managed care program under the state plan subject to 
special rules at section 1932(a)(2) of the Act, and the Indian 
enrollment provisions are found at section 1932(a)(2)(C) of the Act. 
That paragraph explicitly provides that a state may not require under 
paragraph (1)--that is, section 1932(a)(1) of the Act--the enrollment 
of an individual who is an Indian unless the managed care entity 
contracted with the state is the Indian Health Service, an Indian 
health program operated by an Indian tribe or tribal organization under 
the Indian Self-Determination Act, or an urban Indian health program 
operated under Title V of the Indian Health Care Improvement Act. 
Because section 1932(a)(2)(C) of the Act refers to the state option to 
authorize a Medicaid managed care program under section 1932(a) 
authority, the prohibition on mandatory enrollment of Indians into a 
Medicaid managed care program can only be read as limited to that 
authority.
    Many states use section 1115(a) demonstration authority to operate 
Medicaid managed care programs. For managed care programs operated 
under either section 1915(b) or 1115(a) authorities, tribal 
consultation must be conducted in accordance with the approved Tribal 
Consultation state plan, and as approval of waivers is at the 
discretion of the Secretary, we verify that the required processes were 
followed to solicit robust tribal input before determining whether to 
permit states to mandatorily enroll Indians into managed care. We take 
this opportunity to address the statement by commenters that past 
practice under section 1115(a) demonstrations was a decision not to 
waive section 1932(a)(2)(C) of the Act. That is not correct. Section 
1115(a) of the Act authorizes the Secretary to waive provisions of 
section 1902 of the Act and grant expenditures of FFP under section 
1903 of the Act. As discussed above, section 1932(a)(2)(C) of the Act 
applies only to managed care programs operated under section 1932(a) of 
the Act. Any past decisions not to permit mandatory enrollment of 
Indians into managed care under section 1115(a) demonstration authority 
was the result of negotiations with those specific states and tribes. 
We decline to formalize any past practice related to Indian enrollment 
into managed care under section 1115(a) demonstrations in this 
regulation.
    However, in light of the significant comments received on the 
differences across managed care authorities and the parameters for 
mandatory enrollment of Indians, we intend to develop sub-regulatory 
guidance on mandatory enrollment of Indians under section 1932(a), 
1915(b), and 1115(a) authorities through the tribal consultation 
process.
    Comment: Several commenters were supportive of codifying the 
protections in section 1932(h) of the Act, as added by section 5006(d) 
of ARRA at proposed Sec.  438.14. However, commenters stated that these 
statutory protections were designed to supplement, not replace the 
protections from mandatory enrollment in section 1932(a)(2)(C) of the 
Act, and remain important for American Indians and Alaska Natives who 
are enrolled in managed care and continue to receive services from an 
IHCP.
    Response: We appreciate the comments in support of Sec.  438.14 
generally. The provisions of Sec.  438.14, as finalized here, will 
apply to managed care programs regardless of the authority used by the 
state to operate its Medicaid managed care program. As described above, 
the prohibition on mandatory enrollment for Indians only applies to 
managed care programs operated under section 1932(a) of the Act. We did 
not receive comments on paragraph (a) that would define ``Indian,'' 
``Indian health care provider (IHCP),'' and ``Indian managed care 
entity (IMCE)'' consistent with statutory and existing regulatory 
definitions and will finalize those definitions as proposed. Upon 
review of proposed Sec.  438.14, we identified a number of paragraphs 
that incorrectly included PCCMs or did not include PCCM entities. To 
correct this error, we will strike ``PCCM'' from Sec.  438.14(b), 
(b)(2)(i), (b)(5), and (c)(3), and include a reference to PCCM 
``entity'' in paragraphs (b) and (b)(5) in the final rule. These 
corrections have been made to more accurately reflect the obligations 
of PCCMs and PCCM entities. For example, it excludes PCCMs from network 
adequacy, rate negotiation, and claim payment provisions since PCCMs do 
not perform those functions. We believe that implementing these 
requirements for PCCM entities, which may have networks of providers or 
process claims, meet the statutory requirements in section 1932(h) of 
the Act that impose

[[Page 27746]]

these access and payment standards on PCCMs generally.
    Comment: Many commenters recommended that CMS strengthen Sec.  
438.14(b) by requiring oversight and enforcement of states and 
contracted managed care plans to ensure compliance with the Indian-
specific requirements. Commenters also stated that managed care plans 
are not abiding by the cost sharing prohibitions for Indians under 
Sec.  447.56. In addition, commenters recommended that CMS must require 
that managed care plans actively and regularly provide verification to 
CMS that they are in compliance with Sec.  438.14. Some commenters also 
suggested that the quality assessment activities required under subpart 
E of part 438 address compliance with the Indian-specific provisions in 
Sec.  438.14.
    Response: As proposed and finalized, the regulatory language in 
Sec.  438.14 imposes on the state the responsibility to oversee the 
compliance of their contracted managed care plans with the provisions 
of Sec.  438.14, which must be incorporated into the contract between 
the state and the managed care plan. Because the state is the direct 
contractor with the managed care plans, we believe it is not 
appropriate to require managed care plans to directly verify compliance 
with Sec.  438.14 with CMS; this division of responsibility is 
consistent with how Medicaid operates. Regarding comments about managed 
care plans failure to adhere to the cost sharing protections for 
Indians at Sec.  447.56, we note that Sec.  438.108 incorporates the 
cost sharing provisions in Sec. Sec.  447.50 through 448.82 of this 
chapter as a contractual requirement. In the event managed care plans 
are inappropriately assessing cost sharing on Indian enrollees, such 
non-compliance must be brought to the attention of the states as a 
contract compliance issue to be remedied.
    In reference to comments about including Sec.  438.14 under subpart 
E, we interpret those comments as equating the requirements in relation 
to quality assessment in subpart E with a state's general oversight of 
the provisions in 42 CFR part 438. The quality assessment activities in 
Sec.  438.330 are developed by the state and under this rule CMS may 
specify performance measures and performance improvement initiatives 
through a public notice and comment process. There are many provisions 
in subpart E related to performance improvement initiatives that would 
impact all populations covered under a managed care contract. Due to 
the scope of subpart E, it is not appropriate or necessary to include a 
cross-reference to the contractual requirements in Sec.  438.14.
    Comment: Several commenters suggested that in order for managed 
care plans and PCCM entities, to the extent the PCCM entity has a 
provider network, to meet the requirement at Sec.  438.14(b)(1) that 
there be ``sufficient'' IHCPs in the networks, the regulations should 
be amended to require the managed care plans or PCCM entities to 
demonstrate sufficiency by offering network provider agreements using 
an Indian Managed Care Addendum to all IHCPs in their service area who 
request one. Commenters also requested clarification as to how CMS will 
determine that the IHCP network is sufficient to satisfy Sec.  
438.14(b).
    Commenters responded affirmatively to CMS' request for comment as 
to whether there should be a contract addendum for IHCP participation 
in Medicaid managed care networks similar to those created for QHPs and 
Medicare Part D plans and recommended that its use by Medicaid managed 
care plans be required rather than optional. Several commenters stated 
that managed care plans use non-negotiable network provider agreements 
that require IHCPs to waive their federal rights under the Indian 
Health Care Improvement Act and other laws and apply licensing and 
provider certification requirements on IHCPs that are also inconsistent 
with the Indian Health Care Improvement Act.
    Response: We decline to require managed care plans to offer a 
network provider agreement to all IHCPs as we believe we lack clear and 
specific statutory authority to mandate such a requirement at the 
federal level. The standard in Sec.  438.14(b)(1) for the sufficiency 
of IHCPs in a managed care network must consider the anticipated Indian 
enrollment and the capacity of network IHCPs to meet the needs of that 
population. States would have the flexibility to specify in the managed 
care contract that the managed care plans must offer a provider 
agreement to all IHCPs in the service area or establish other measures 
of network adequacy similar to Sec.  438.68 or other appropriate 
measures. We decline to set specific standards for sufficiency of IHCPs 
in managed care plan networks since Sec.  438.14(b)(4) provides that 
Indian enrollees have the ability to receive care from out-of-network 
IHCPs. This is a consistent with our position in response to comments 
that we specify standards for family planning providers in Sec.  438.68 
due to the ability to receive such services from out-of-network family 
planning providers.
    Notwithstanding out-of-network access, Sec.  438.14(b) does require 
that managed care plans and PCCM entities, as appropriate, demonstrate 
that there are a sufficient number of IHCPs in the network unless there 
are no or too few IHCPs to ensure timely access to services for Indian 
enrollees. We appreciate the engagement and the work of the TTAG to 
date to develop a draft Indian Managed Care Addendum and we are 
committed to finalizing that addendum through subregulatory guidance to 
offer to managed care plans on a voluntary basis, to facilitate the 
network status of IHCPs. Because we do not have explicit statutory 
authority to require the use of an addendum by managed care plans for 
the provider agreements with IHCPs, we will follow an approach similar 
to QHPs operating under the FFM. CMS issued a Dear Tribal Leader Letter 
that introduced the QHP Addendum for IHCPs to facilitate QHP 
contracting with tribes, Urban Indian Health programs, and IHS 
providers, and specified that use of the addendum was encouraged by 
QHPs and providers but, ultimately, the addendum was optional, see 
http://www.ihs.gov/newsroom/includes/themes/newihstheme/display_objects/documents/IndianHealthEssentialCommunityProviders_Final.pdf. We recognize that 
some states have required the use of an addendum through Medicaid 
managed care contracts and we encourage states to do so to facilitate 
provider agreements with IHCPs and to ensure that managed care programs 
meet the needs of Indian enrollees.
    Comment: We received several comments in support of Sec.  
438.14(b)(5)(i) that would permit an Indian enrollee who is located in 
a state with few or no IHCPs to access services from out of state 
IHCPs, as well as the provision that the state could consider the 
presence of few or no IHCPs as a for cause reason to disenroll from the 
managed care program at Sec.  438.14(b)(5)(ii). However, some 
commenters recommended that Sec.  438.14(b)(5) should only be in effect 
if the managed care plan's service area has no IHCPs, rather than 
``few'' as proposed. In addition, commenters requested clarification as 
to the options available to an Indian were he or she to disenroll from 
the managed care program under Sec.  438.14(b)(5)(ii).
    Response: Section 438.14(b)(4) sets forth the procedures for 
demonstrating adequate access which we are directed to establish under 
the last sentence of section 1932(h)(2)(A)(ii) of the Act, and permits 
Indian enrollees to obtain covered services from an out-of-network IHCP 
from whom the enrollee is otherwise eligible to receive services.

[[Page 27747]]

Due to this flexibility for enrollees to see out-of-network IHCPs, we 
decline to apply the operation of the disenrollment right in paragraph 
(b)(5)(ii) only to instances where no IHCPs are in the managed care 
plan's service area. In cases where the state deems the presence of few 
or no IHCPs as a for cause disenrollment reason for Indian enrollees 
from the managed care program, a FFS delivery system would have to be 
maintained by the state to provide Medicaid covered services. Because 
Indian enrollees may see out-of-network IHCPs under Sec.  438.14(b)(4) 
and out-of-state IHCPs under paragraph (b)(5)(i), we do not anticipate 
that states will choose to utilize the provision for disenrollment 
specified in paragraph (b)(5)(ii) with significant frequency; 
regardless, we believe it is important to include it as an option in 
the final rule. However, we anticipate that the use of the Indian 
Managed Care Addendum will facilitate the inclusion of IHCPs in managed 
care networks and reduce the instances of reliance on paragraph (b)(5). 
We will finalize paragraph (b)(5) as proposed.
    Comment: We received several comments stating that managed care 
plans auto-assign beneficiaries to particular primary care providers in 
a manner that is inconsistent with the right of Indians to choose an 
IHCP that is participating the managed care plan's network as their 
primary health care provider in section 1932(h)(1) of the Act and as 
proposed at Sec.  438.14(b)(3). The administrative burden associated 
with correcting these issues is extremely timely and expensive, costing 
CMS, the states, and Tribes valuable resources and ultimately affecting 
the quality and timely care that a patient receives.
    Response: We agree with commenters that, to the extent possible, 
managed care plans should support the intent of section 1932(h)(1) of 
the Act and Sec.  438.14(b)(3) when auto-assigning Indians to primary 
care physicians. Managed care plans should review their auto-assignment 
algorithm to ensure that appropriate logic is included to accomplish 
the most appropriate PCP assignment. Additionally, managed care plans 
should ensure that information on the process for changing primary care 
providers is easily accessible and, at a minimum, in the enrollee 
handbook and on the managed care plan's Web site.
    Comment: We received several comments supporting the payment 
provisions in Sec.  438.14(b)(2) and (c)(2). However, commenters 
believed proposed Sec.  438.14(c)(2) should be clearer in indicating 
which rate--the State plan or the published encounter rate--the IHCP is 
entitled to receive. Commenters explained that in most cases, the state 
plan should provide for payment to IHCPs at the encounter rate, 
although there may be exceptions. Commenters believed this section 
should be revised to clarify that IHCPs should have the right to 
payment at either the rate set out in the state plan or the encounter 
rate, whichever is higher.
    Response: Proposed Sec.  438.14(c)(2) explains that the IHCP is to 
be paid under the reimbursement methodology outlined in the state plan 
when the IHCP is not an FQHC (and therefore not entitled to FQHC 
payment rates). We agree Sec.  438.14(c)(2) is not clear as proposed; 
therefore, we will amend Sec.  438.14(c)(2) to specify that the IHCP is 
entitled to receive the encounter rate published in the Federal 
Register annually by the Indian Health Service, or in the absence of a 
published encounter rate, the amount the IHCP would receive if the 
services were provided under the State plan's FFS payment methodology. 
We believe this revision more clearly reflects the requirements from 
section 1932(h)(2)(C)(ii) of the Act. Additionally, consistent with 
section 1932(h)(2)(C)(ii) of the Act, paragraph (c)(3) provides for the 
state to pay the difference should the managed care plan pay less than 
the required amount. As these payments from the state to a provider are 
required by the statute, they fall under the exception to the general 
rule in Sec.  438.60 (otherwise prohibiting state payments directly or 
indirectly to health care providers for services covered by a managed 
care contract).
    Comment: Some commenters noted that the provisions of section 
1932(h) of the Act, as added by section 5006(d) of ARRA, which were 
proposed at paragraph (c)(3), require the state to make a supplemental 
payment to IHCPs when the amount negotiated or received by the IHCP 
from the managed care plan is less than the amount required under the 
encounter rate or the state plan; these commenters stated that such 
supplemental payment requirements from the state result in payment 
delays for the reconciliation amounts. Commenters noted that some 
states are considering requiring the managed care plans to pay at the 
required encounter or state plan rates to reduce delays in full 
reimbursement to IHCPs.
    Response: We acknowledge that the provisions of Sec.  438.14(c)(3) 
do not prohibit the state from requiring managed care plans to 
reimburse IHCPs at the specified encounter or state plan rate as the 
regulatory language specifies that the state must make a supplemental 
payment to IHCPs if the amount received by the IHCP from the managed 
care plan is less than the amount required under paragraph (c)(2). This 
is consistent with section 1932(h)(2)(C)(i)(II) of the Act which 
stipulates that the state must pay, in a timely manner, the difference 
between the amount paid by the managed care plan and the amount owed to 
the IHCP under the state plan. States would have the option to build 
the required reimbursement levels into the capitation rates and require 
managed care plans to reimburse IHCPs at those rates through the 
managed care contract. All FQHC payment rules under section 1902(bb) of 
the Act apply in the context of IHCPs that are designated as FQHCs and 
this statutory provision is accommodated by the exception to the 
general rule on state direction of managed care plan expenditures at 
Sec.  438.6(c)(1). In addition, the non-FQHC IHCP payment requirements 
at section 1932(h)(2)(C)(ii) of the Act are similarly accommodated by 
Sec.  438.6(c)(1)(iii) because the state is permitted to set minimum 
(for example, the state plan rate) or maximum fee schedules (see 
discussion of Sec.  438.6(c)(1)(iii) in section I.B.3.d) for a specific 
class of providers (for example, IHCPs).
    Comment: Some commenters believed that the care coordination 
standards and prior authorization requirements at the managed care plan 
level are inconsistent with how IHCPs coordinate care, both within the 
system of IHCPs and with outside providers. Commenters expressed 
concern that this can result in a managed care plan paying twice for 
the same service. For example, an out-of-network IHCP is reimbursed for 
providing primary care services to an Indian enrollee, but the Indian 
enrollee is also required to see a network primary care provider to 
obtain a referral for specialty care, which results in another payment 
by the managed care plan for a duplicative primary care visit. 
Commenters recommended that the final rule require managed care plans 
to waive the requirements for referrals and prior authorizations from a 
network primary care provider if the enrollee receives his or her 
primary care through an out-of-network IHCP who adheres to the managed 
care plan's referral processes.
    Response: We understand the commenters' concern and agree that 
duplicative services and payments should be avoided if possible. Thus, 
under our authority in section 1902(a)(4) of the Act, we have added a 
new requirement at Sec.  438.14(b)(6) to clarify that MCO, PIHPs, and 
PAHPs must permit an out-of-network IHCP to

[[Page 27748]]

refer an Indian to a network provider. This provision prohibits the 
managed care plan from requiring the Indian to receive the referral 
from an in-network primary care provider under those circumstances. The 
goal, as evidenced by our commitment to issue an Indian Managed Care 
Addendum, is to create an environment for provider contracting 
arrangements between managed care plans and IHCPs that is cognizant of 
the federal protections afforded these providers while integrating 
IHCPs into managed care networks to ensure that Indian enrollees have 
access to a comprehensive and integrated service package.
    Comment: One commenter raised the issue of difficulties encountered 
by states in conducting mandatory licensure reviews of facilities on 
reservations.
    Response: We appreciate this comment but licensure reviews for 
facilities on reservations are outside the scope of this rule. It is 
our understanding that most states require an attestation by IHS or 
tribal facilities that licensure standards are met and thus, review by 
the state survey agencies is not necessary.
    Comment: A few commenters recommended that CMS exempt American 
Indians/Alaska Natives (AI/ANs) from all Medicaid estate recovery 
requirements, or include in the draft regulations additional 
requirements for providing information and counseling about Medicaid 
estate recovery to AI/ANs, during the Medicaid application process. The 
commenters suggested providing detailed written information about 
estate recovery requirements and exemptions currently available to AI/
ANs, providing counseling to the AI/AN to determine types of ownership 
subject to estate recovery, identifying the status of the applicant's 
ownership interest as exempt or not exempt from estate recovery, 
explaining how an estate recovery claim is calculated for a beneficiary 
enrolled in Medicaid managed care, obtaining the non-exempt AI/AN's 
written consent for estate recovery, and providing an annual summary of 
accrued costs to the beneficiary.
    Response: This comment is outside the scope of this rule. We note 
that the statutory authority for Medicaid estate recovery is separate 
and distinct from the authority for Medicaid managed care, and that 
estate recovery applies to Medicaid beneficiaries age 55 and over, or 
permanently institutionalized, whether they are enrolled in a Medicaid 
MCO or not. We also note that the commenters' concerns and 
recommendations have been shared with CMS by the Tribal Technical 
Advisory Group (TTAG) and other concerned parties, and we are currently 
reviewing them.
    After consideration of the public comments, we are finalizing with 
the following revisions. Technical corrections to punctuation and text 
(including deletions of unnecessary citations) have been made in 
paragraph (a). The heading of paragraph (b) has been made more accurate 
by adding ``and coverage.'' Additionally, throughout paragraphs (b) and 
(c) as appropriate, ``and'' was replaced with ``or'' in the lists of 
managed care plan types to be clear that an enrollee in any of the 
listed types of plans has the listed rights. Corrections related to 
references to a PCCM and/or PCCM entity have been made in paragraphs 
(b), (b)(2)(i), (b)(4), (b)(5), and (c)(3) to reflect the various 
activities and functions of each. We are also finalizing a new 
paragraph (b)(6) which permits IHCPs to refer Indians to network 
providers. Minor grammatical corrections have been made in paragraphs 
(c)(1) and (c)(3). Revisions for clarification to the applicable 
payment rates have been made in paragraph (c)(2). A citation has been 
added to paragraph (d) to clarify the definition of ``Indian Health 
Program.''
c. Emergency and Post-Stabilization Services (Sec.  438.114)
    We proposed to revise portions of Sec.  438.114 to make technical 
corrections to the existing regulations. We did not propose any changes 
to paragraph (a), (d), and (f).
    We proposed to correct an error in the current regulations at 
paragraph (b) by removing paragraph (b)(2) which refers to PCCMs with a 
risk contract. This provision is inconsistent with the rest of our 
managed care regulatory structure, in that a PCCM which accepts risk 
for medical services--including the emergency services referenced in 
this section--would be considered either a PAHP or PIHP (depending on 
the scope of medical services at risk). Because a PCCM would never be 
responsible for coverage and payment of emergency services, we proposed 
to remove that reference from paragraph (b). A state will always be 
responsible for coverage and payment of emergency services if it 
operates a PCCM program, which is reflected in the proposed revisions 
to paragraph (b)(2), where we proposed to move the existing text in 
paragraph (b)(3) with the addition of ``PCCM entities.''
    In paragraph (c)(1), we proposed to add PCCM entity to each 
reference to ``MCO, PIHP, PAHP, or PCCM'' for consistency with changes 
discussed in I.B.6.e of the proposed rule. In paragraph (c)(2), we 
proposed to redesignate paragraph (c)(2)(i) as (c)(2) and delete 
paragraph (c)(2)(ii) for the same reason as the proposal for paragraph 
(b).
    Currently in paragraph (e), MCOs, PIHPs, and PAHPs must follow MA 
guidelines when covering post-stabilization services and be paid in 
accordance with Medicare guidelines. However, payment for post-
stabilization services to Medicaid enrollees is governed by Medicaid 
and State rules. We corrected this misleading provision by proposing 
language that ensures that hospitals providing post-stabilization 
services receive payment consistent with federal and state Medicaid 
payment standards, not based on Medicare rates. The resulting language 
would apply MA coverage guidelines to MCOs, PIHPs and PAHPs but 
Medicaid payment standards for covered post-stabilization services.
    We received the following comments in response to our proposal to 
revise Sec.  438.114.
    Comment: Several commenters recommended that CMS clarify the 
coverage and payment rules at Sec.  438.114(c) and (d). Several 
commenters recommended that CMS clarify that only emergency department 
physicians can determine if an emergency medical condition or non-
emergency condition is present, not the MCO, PIHP, PAHP, or state. 
Commenters also recommended that CMS require MCOs, PIHPs, PAHPs, and 
the state to provide payment for both the medical screening and 
evaluation and the emergency services, regardless of provider network 
status. One commenter recommended that CMS require the prohibition and 
elimination of all triage payments. Several commenters recommended that 
CMS reinforce the prudent layperson (PLP) requirements of the BBA of 
1997 and clarify for MCOs, PIHPs, PAHPs, and states that limiting 
coverage and payment for emergency services based on approved lists of 
emergency diagnosis codes is prohibited. Several commenters stated that 
MCOs, PIHPs, PAHPs, and states are denying coverage and payment of 
emergency services when the final diagnosis on the claim is not on the 
approved list of emergency diagnosis codes. One commenter recommended 
that CMS remove the prohibition to use an approved list of emergency 
diagnosis codes to assess the appropriate use of emergency services. 
The commenter stated that many states and managed care plans rely on 
such

[[Page 27749]]

code lists to determine appropriate payment levels for emergency room 
use.
    Response: We decline to add explicit text that only emergency 
department physicians can determine if an emergency medical condition 
or non-emergency condition is present. Managed care plans and states 
maintain both medical necessity criteria and clinical standards and 
consult regularly with health care providers. We also decline to add 
coverage and payment requirements for the medical screening and 
evaluation. Consistent with Sec.  438.114(c)(1)(i), managed care plans 
and states must cover and pay for emergency services regardless of 
whether the provider that furnishes the services has a contract. We 
also decline to prohibit and eliminate all triage payments. States and 
managed care plans have discretion to pay and cover medical screenings 
and evaluations for non-emergent conditions, including triage payments. 
We note that EMTALA requires screening for emergency medical conditions 
but does not specify or require payment for that screening.
    Regarding the PLP requirements of the BBA of 1997 and the use of 
approved lists of emergency diagnosis codes, we remind commenters that 
consistent with our discussion in the 2002 managed care final rule at 
67 FR 41028-41031, we prohibit the use of codes (either symptoms or 
final diagnosis) for denying claims because we believe there is no way 
a list can capture every scenario that could indicate an emergency 
medical condition under the BBA provisions. Section 1932(b)(2)(B) of 
the Act defines emergency services as covered inpatient or outpatient 
services that are furnished by a provider qualified to furnish these 
services under Medicaid that are needed to evaluate or stabilize an 
``emergency medical condition.'' An ``emergency medical condition'' is 
in turn defined in section 1932(b)(2)(C) of the Act as a medical 
condition manifesting itself by acute symptoms of sufficient severity 
(including severe pain) that a prudent layperson, who possesses an 
average knowledge of health and medicine, could reasonably expect the 
absence of immediate medical attention to result in placing the health 
of the individual (or for a pregnant woman, the health of the woman or 
her unborn child) in serious jeopardy, serious impairment to body 
functions, or serious dysfunction of any bodily organ or part. While 
this standard encompasses clinical emergencies, it also clearly 
requires managed care plans and states to base coverage decisions for 
emergency services on the apparent severity of the symptoms at the time 
of presentation, and to cover examinations when the presenting symptoms 
are of sufficient severity to constitute an emergency medical condition 
in the judgment of a prudent layperson. The final determination of 
coverage and payment must be made taking into account the presenting 
symptoms rather than the final diagnosis. The purpose of this rule is 
to ensure that enrollees have unfettered access to health care for 
emergency medical conditions, and that providers of emergency services 
receive payment for those claims meeting that definition without having 
to navigate through unreasonable administrative burdens. We note that 
managed care plans have a responsibility to reach out to enrollees and 
provide and manage care such that enrollees do not use the emergency 
room in place of primary care.
    Comment: One commenter recommended that CMS add standards at Sec.  
438.114(c)(1)(ii) to require that payment is not denied when an 
enrollee has not been able to obtain non-emergency services in a timely 
manner.
    Response: We decline to accept the commenter's recommendation, as 
managed care plans must ensure timely access to care consistent with 
the requirements at Sec.  438.206(c)(1). It is not appropriate to 
require coverage and payment of non-emergent conditions in an emergency 
setting when managed care plans are responsible for providing timely 
access to care in the appropriate setting.
    Comment: A few commenters recommended that CMS continue to require 
the payment of post-stabilization care services at Sec.  438.114(e) at 
the Medicare rate and not the Medicaid rate. One commenter recommended 
that CMS add ``applicable state Medicaid laws and regulations'' after 
``Title XIX of the Act and the States.''
    Response: The provision at Sec.  438.114(e) was never intended to 
require payment for post-stabilization care services at the Medicare 
rate. We only intended to require coverage of post-stabilization care 
services in accordance with the provisions at Sec.  422.113(c) of this 
chapter but not to mandate a payment rate using Medicare standards. 
Consistent with section 1932(b)(2)(D) of the Act, payment for post-
stabilization care services is required in accordance with Title XIX of 
the Act. We also decline to add ``applicable state Medicaid laws and 
regulations'' after ``Title XIX of the Act and the States,'' as we 
believe it is duplicative and does not flow with the existing 
regulatory text.
    After consideration of the public comments, we are finalizing Sec.  
438.114 as proposed without modification.
8. Other Provisions
    We received comments on sections that were not discussed in the 
preamble of the proposed rule. In these instances, the proposed rule 
restated the current regulation text without change. We have included 
those sections, along with the comments and responses, below.
a. Provider Discrimination Prohibited (Sec.  438.12)
    Comment: One commenter recommended that managed care plans have on-
going monthly monitoring processes to ensure compliance with state and 
federal provider nondiscrimination contract provisions.
    Response: As for all contractual provisions, states and managed 
care plans should have monitoring mechanisms to ensure on-going 
compliance. We note that in accordance with Sec.  438.66(b)(10), states 
must have a monitoring system that addresses provider network 
management, which includes compliance with all state and federal 
provider nondiscrimination contract provisions. We encourage all states 
and managed care plans to ensure that the appropriate processes are in 
place to meet this requirement.
    Comment: We received one comment recommending that CMS clarify that 
Sec.  438.12(a)(1) applies both to states and managed care plans. The 
commenter also requested that CMS clarify that excluding a provider 
entirely from the network is not the only prohibited form of 
discrimination; actions such as inferior reimbursement are also 
prohibited.
    Response: We believe the commenter is requesting that CMS apply the 
provisions of Sec.  438.12 to state FFS providers, which is outside the 
scope of this rule. The text of Sec.  438.12(a)(1) is adequate to 
prohibit discrimination for provider participation, reimbursement, and 
indemnification as it specifies that an MCO, PIHP, or PAHP may not 
discriminate in the participation, reimbursement, or indemnification of 
any provider who is acting within the scope of his or her license or 
certification under applicable State law, solely on the basis of that 
license or certification. The text is significantly similar to the 
statutory provision it implements, which is section 1932(b)(7) of the 
Act, in identifying the scope of the anti-discrimination mandate.
    Comment: One commenter recommended that CMS specify a time frame 
for managed care plans to send

[[Page 27750]]

the notice to providers required in proposed Sec.  438.12(a)(1).
    Response: We do not believe that level of detail is necessary in 
Sec.  438.12(a)(1). States can address that in the managed care plan 
contract or state laws that address credentialing. We decline to amend 
Sec.  438.12(a)(1) in response to this comment.
    Comment: A few commenters recommended that CMS amend Sec.  438.12 
to prohibit a managed care plan from discriminating against an 
otherwise qualified health care provider on the basis that the provider 
furnishes certain services under their scope of practice, on the basis 
of the patients they serve, or on the basis of the professional 
activity or advocacy they conduct separately from their contractual 
relationship with the managed care plan. Another commenter recommended 
that managed care plans be prohibited from refusing to contract with 
providers because the provider offers services to which the managed 
care plan objects. This commenter believed that CMS should clarify that 
Medicaid managed care plans may not prohibit contracted providers from 
prescribing or providing services or treatments that are covered under 
the contract. Another commenter recommended that CMS include a list of 
the activities that are prohibited. Likewise, CMS should require that 
agreements between Medicaid managed care plans and participating 
providers reinforce this standard.
    Response: We believe that the commenters' references to 
discrimination ``on the basis that the provider furnishes certain 
services under their scope of practice, on the basis of the patients 
they serve, on the basis of the professional activity or advocacy they 
conduct'' or ``services that the managed care plan objects to'' meant 
that the activities and services triggering the discriminatory 
treatment are services and activities within the scope of the 
provider's licensure. As such, this is already addressed in proposed 
Sec.  438.12(a)(1), which clearly indicates that a managed care plan 
may not discriminate against a provider solely for providing services 
within their scope of licensure. The text in Sec.  438.12(a)(1) is 
significantly similar to the specific statutory provision it 
implements, section 1932(b)(7) of the Act, in identifying the scope of 
the anti-discrimination mandate.
    We disagree with the commenter that Medicaid managed care plans 
must allow contracted providers to prescribe or provide all services 
covered under the contract that are within the provider's scope of 
licensure. We reiterate that Sec.  438.12 does not force managed care 
plans to contract with every provider for every covered service. 
Section 438.12(b) explicitly limits the effect of the prohibitions in 
paragraph (a) and does not prohibit flexibility in reimbursements or 
prohibit plans from establishing measures to maintain quality and 
control costs. Therefore, managed care plans can contract for less than 
the full scope of services available from a provider and/or for less 
than the full scope of services covered in the managed care plan's 
contract with the state. It is outside the scope of part 438 to mandate 
specific provisions in the contract between a managed care plan and its 
providers. We believe Sec.  438.12 is sufficiently broad to address 
many forms of discrimination but cannot include an exhaustive list of 
all possible types of, or basis for, discrimination. We decline to 
amend Sec.  438.12 in response to these comments.
    Comment: One commenter requested that CMS clarify that managed care 
plans are prohibited from discriminating against providers on the basis 
of their race, color, or national origin, language, disability, age, 
sex, gender identity, or sexual orientation.
    Response: We appreciate the opportunity to clarify that, as 
provided in Sec.  438.3(f)(1), all Medicaid managed care plan contracts 
must comply with all applicable federal and state laws and regulations 
including Title VI of the Civil Rights Act of 1964; Title IX of the 
Education Amendments of 1972 (regarding education programs and 
activities); the Age Discrimination Act of 1975; the Rehabilitation Act 
of 1973; the Americans with Disabilities Act of 1990 as amended; and 
section 1557 of the Patient Protection and Affordable Care Act. Under 
these identified statutes and their implementing regulations, managed 
care plans are prohibited from discriminating against providers (for 
example, rejecting a provider's participation in a plan's network) on 
the basis of the provider's race, color, national origin, disability, 
age, or sex. The Department's 1557 guidance and the final 1557 
regulation provide more information on what constitutes sex 
discrimination. See www.hhs.gov/ocr. Other laws, such as state laws, 
that prohibit discrimination may also be applicable to manage care 
plans.
    Comment: We received one comment requesting that CMS specify that 
written notice requirements apply to providers seeking to be included 
in a managed care plan network and those that are terminated from a 
plan network.
    Response: The proposed text in Sec.  438.12(a) is sufficiently 
clear in addressing existing and prospective providers and a revision 
to address terminated providers is not necessary.
    After consideration of the public comments, we are not amending 
Sec.  438.12 in response to these comments. Please refer to section 
I.B.9.a of this final rule for discussion of a change to Sec.  
438.12(a)(2) related to defined terms.
b. Enrollee Rights (Sec.  438.100)
    Comment: We received one comment asking CMS to clarify how an 
enrollee can address issues with a managed care plan regarding ADA 
accommodation or modification.
    Response: We appreciate the opportunity to clarify that enrollees 
can avail themselves of the grievance system in a managed care plan 
(see Sec.  438.400) to request an accommodation or question the failure 
to provide an accommodation. If that does not adequately address the 
concern, then the enrollee should contact the state Medicaid agency or 
the HHS Office for Civil Rights.
    Comment: We received one comment regarding Sec.  438.100(b)(2)(iii) 
stating that while the state can include this provision in an MCO 
contract that an enrollee has this right, it has no mechanism to 
enforce this provision of the proposed rule or to guarantee to CMS that 
the regulation is followed by providers. The commenter believed that 
discussions about treatment options and alternatives should be 
occurring between the enrollee and his provider, and it is up to 
providers to discuss treatment options with their patients without 
interference from the state or the managed care plan.
    Response: We agree that discussions about treatment options and 
alternatives should occur between the enrollee and their provider and 
that the primary responsibility for discussing treatment options and 
alternatives rests with the provider. We appreciate the opportunity to 
provide guidance on this provision. We note that providers are 
generally under contract with the managed care plan, and the plan can 
include contract terms with network providers to specifically include 
Sec.  438.100(b)(2)(iii). Also, when a managed care plan makes a 
coverage determination about treatment, Sec.  438.100(b)(2)(iii) would 
apply. This provision was included in the 2002 final rule to reiterate 
the state's and managed care plan's responsibility to ensure that they 
support this right and do not have policies, procedures, or contractual 
provisions that infringe or impede it. This provision is a complement 
of Sec.  438.102(a) about how managed care plans cannot prohibit 
providers from acting within the lawful scope of their practice in 
providing

[[Page 27751]]

counseling or referral services to a patient who is an enrollee but 
also provides necessary protections to enrollees by requiring states to 
ensure that information is adequately provided to enrollees in a manner 
appropriate to their ability to understand and their condition.
    Comment: Several commenters recommended that CMS address an 
enrollee's right to indicate an alternative address for confidential or 
sensitive information. The commenters believed managed care plans 
should be required to notify enrollees of this option and how to 
exercise it.
    Response: 45 CFR 164.522(b) requires health care providers and 
health plans to accommodate reasonable requests to receive 
communications by alternative means or at alternative locations. As 
such, all Medicaid managed care plans (and most health care providers) 
should already be in compliance as part of their compliance with HIPAA 
Privacy Rule compliance.
    Comment: We received a few comments recommending that proposed 
Sec.  438.100(d) should be consistent with Sec.  438.3(f)(1), which 
provides a more complete list of enrollee protections.
    Response: Revisions have been made to Sec.  438.100(d) to include 
all laws referenced in Sec.  438.3(f)(1).
    After consideration of the public comments, Sec.  438.100 will be 
finalized as proposed except for an amendment to Sec.  438.100(d) for 
consistency with Sec.  438.3(f)(1).
c. Provider-Enrollee Communications (Sec.  438.102)
    Comment: One commenter recommended that CMS require states and 
managed care plans to provide all enrollees the ability to redirect 
communications to an alternate physical or electronic address in Sec.  
438.102.
    Response: 45 CFR 164.522(b) requires health care providers and 
managed care plans to accommodate reasonable requests to receive 
communications by alternative means or at alternative locations. As 
such, all Medicaid managed care plans (and most health care providers) 
should already be in compliance as part of their compliance with HIPAA 
Privacy Rule compliance.
    Comment: We received one comment recommending that managed care 
plans not be allowed to exclude any benefit covered under the state's 
Medicaid managed care program from their coverage, including benefits 
that the managed care plan objects to on moral or religious grounds. 
The commenter believed that since states identify the benefits to be 
covered by the contract as part of the procurement process, selected 
managed care plans should not be able to later decide to discontinue 
covering a service.
    Response: Section 1932(b)(3)(B) of the Act provides that a managed 
care plan is not obligated to furnish or pay for a particular 
counseling or referral services if (1) the managed care plan objects to 
the provision of that counseling or referral service on moral or 
religious grounds, and (2) provides information to the state, 
prospective enrollees, and to current enrollees with 90 days after 
adopting the policy for objections of any particular service. 
Therefore, we cannot remove the ability of a managed care plan to 
object to the coverage of referral or counseling services provided by 
health care professionals as described in section 1932(b)(3)(A) of the 
Act on moral or religious grounds through regulation. We decline to 
modify this section to address the commenter's suggestion.
    After consideration of the public comments, we are amending Sec.  
438.102(b)(2) to be more consistent with Sec.  438.10(g)(2)(ii)(B); see 
section I.B.6.d. for discussion of this revision.
d. Liability for Payment (Sec.  438.106)
    Comment: A few commenters recommended that CMS add a new provision 
at Sec.  438.106 to prohibit managed care plans from charging 
enrollees, or holding enrollees liable for payment, for out of network 
family planning services and supplies.
    Response: We decline to adopt commenters' recommendations to add a 
new provision at Sec.  438.106 to prohibit managed care plans from 
charging enrollees, or holding enrollees liable for payment, for out of 
network family planning services and supplies. Consistent with the 
current language at Sec.  438.106, Medicaid enrollees are not held 
liable for covered services provided to the enrollee consistent with 
paragraphs (b)(1) and (2), including covered family planning services 
and supplies. We do not believe it is necessary to specify any covered 
service in this provision, as the current language is inclusive of all 
covered services.
    After consideration of the public comments, we are not amending 
Sec.  438.106.
e. Cost Sharing (Sec.  438.108)
    Comment: A few commenters recommended that CMS add a new provision 
at Sec.  438.108 to include the provisions of section 2713 of the 
Affordable Care Act that prohibit cost sharing for preventive health 
services.
    Response: Section 2713 of the Affordable Care Act applies to group 
health plans and health insurance issuers offering group or individual 
health insurance coverage and does not generally impose a requirement 
on Medicaid; therefore, we decline to adopt commenters' recommendations 
to add a new provision at Sec.  438.108. However, we encourage states 
and managed care plans to adopt such practices and provide for no cost 
sharing for preventive health services, and we note that section 
4106(b) of the Affordable Care Act established a one percentage point 
increase in the FMAP effective January 1, 2013, to be applied to 
expenditures by states that cover, without cost sharing, preventive 
health services that are assigned a grade of A or B by the United 
States Preventive Services Task Force (USPSTF) and approved vaccines 
and their administration, recommended by the Advisory Committee on 
Immunization Practices (ACIP).
    We also note that effective January 1, 2014, the Affordable Care 
Act requires that Alternative Benefit Plans (ABPs) for beneficiaries, 
including individuals in the new adult eligibility group (that is, 
section 1902(a)(10)(A)(i)(VIII)) of the Act, cover preventive health 
services described in section 2713 of the Affordable Care Act as part 
of the set of Essential Health Benefits (EHBs). The preventive health 
services in section 2713 include the preventive health services 
authorized for increased match under section 4106 of the Affordable 
Care Act.
    After consideration of the public comments, we are not amending 
Sec.  438.108.
f. Solvency Standards (Sec.  438.116)
    Comment: One commenter recommended that CMS must take further steps 
to ensure that network providers are held harmless when managed care 
plans go bankrupt. The commenter suggested the provision of federal 
financing to guarantee the payment of bad debts to providers or 
mandating that managed care plans contribute to a funding pool to cover 
such debts.
    Response: Section 438.116 is based on sections 1903(m)(1) and 
1932(b)(6) of the Act, which requires certain types of MCOs to provide 
assurances to the state that its provision against the risk of 
insolvency is adequate to protect enrollees from financial liability, 
including the debts of the organization, should the managed care plan 
become insolvent; we extended the regulation to PIHPs and PAHPs, as 
well as MCOs under our authority at section 1902(a)(4) of the Act in 
the 2002 final rule. In addition, Sec.  438.116(b) provides that, in

[[Page 27752]]

general, MCOs and PIHPs must meet the solvency standards established by 
the state for private HMOs, or be licensed or certified by the state as 
a risk-bearing entity. Solvency standards for the business of insurance 
are under the state's purview and section 1903(m)(1) of the Act 
requires that enrollees not incur financial liability in the event a 
managed care plan becomes insolvent. Any hold harmless protections for 
network providers should be addressed in the contract between the state 
and the managed care plan to reflect state rather than federal laws, or 
in the contracts between the providers and the managed care plan. For 
these reasons, we decline to mandate that managed care plans maintain a 
reserve to anticipate network provider claims in the event of 
insolvency. In addition, under section 1903(m)(2)(A)(iii) of the Act, 
federal funding for managed care programs is limited to the FFP 
attributable to actuarially sound capitation rates and would not extend 
to the additional federal financing suggested by the commenter.
    After consideration of the public comment, we are not amending 
Sec.  438.116.
g. Confidentiality (Sec.  438.224)
    Comment: Several commenters recommended that CMS strengthen the 
language at Sec.  438.224 to add confidentiality requirements for 
enrollees receiving sensitive and confidential services. Several 
commenters also recommended that CMS add language to protect the 
confidentiality of enrollee medical records, all aspects of enrollee 
coverage and care, and specific communications with health care 
providers. Commenters also recommended that CMS include a requirement 
for managed care plans to inform enrollees of their right to specify an 
alternative mailing address. A few commenters recommended that CMS 
include specific confidentiality requirements for family planning 
services and supplies. One commenter recommended that CMS add a 
reference to include 42 CFR part 2 regarding the confidentiality of 
alcohol and drug abuse patient records. One commenter recommended that 
CMS clarify that states are only required to take appropriate contract 
action and make appropriate referrals for patterns of non-compliance 
with potential privacy violations.
    Response: We believe that the regulatory text provides for the 
appropriate information and references to ensure that all managed care 
contracts comply with the applicable privacy requirements. Section 
438.224, as a whole, is intended to ensure that managed care plans have 
procedures to protect the confidentiality of all enrollees, regardless 
of which services they receive, and includes communications between 
enrollees and providers. We also decline to add specific references to 
42 CFR part 2, as we believe that the reference is unnecessary to 
include given the general context of the current provision. The 
requirements at Sec.  438.224 do not preempt other state or federal 
confidentiality laws and regulations that apply and are more protective 
of enrollee privacy. We also decline to include a requirement for 
managed care plans to inform enrollees of their right to add an 
alternative mailing address, as 45 CFR 164.522(b) requires providers 
and plans to accommodate reasonable requests to receive communications 
by alternative means or at alternative locations. Finally, we clarify 
for the commenter that states should take appropriate contract action 
and make appropriate referrals for patterns of non-compliance with 
potential privacy violations.
    After consideration of the public comments, we are not amending 
Sec.  438.224.
h. Practice Guidelines (Sec.  438.236)
    Comment: A few commenters recommended that CMS include standards at 
Sec.  438.236(b)(1) to require that all practice guidelines be based on 
valid and reliable clinical evidence and be peer reviewed and 
published. One commenter recommended that CMS require practice 
guidelines to be based on valid and reliable clinical evidence when 
available, and otherwise allow a consensus of health care professionals 
in the particular field. One commenter recommended that CMS clearly 
define practice guidelines. One commenter recommended that CMS require 
post-approval adverse event data in adopting practice guidelines 
related to medication therapy.
    Response: We do not agree with commenters that Sec.  438.236(b)(1) 
should be revised to require that all practice guidelines be peer 
reviewed and published. While we encourage managed care plans to 
include peer reviewed and published clinical evidence in the 
development of practice guidelines as feasible, we are also aware that 
clinical practice guidelines are not always available for all areas of 
clinical practice. We note that managed care plans should adopt 
practice guidelines that are based on valid and reliable clinical 
evidence or a consensus of health care professionals in the particular 
field under the existing rule at Sec.  438.236(b)(1).
    We decline to define practice guidelines, as we do not believe it 
is necessary to do so. Practice guidelines are developed by a variety 
of organizations in a variety of areas and are widely available for use 
by health care professionals. Practice guidelines assist health care 
professionals to apply the best evidence-based practice to clinical 
care. We therefore see no compelling reason for CMS to specifically 
define practice guidelines. We also decline to require review or use of 
post-approval adverse event data in adopting practice guidelines 
related to medication therapy, as we do not agree that such specificity 
is needed in the context of the regulatory language. This regulation 
has never specified the kinds of practice guidelines managed care plans 
must adopt but rather establishes criteria to be used by managed care 
plans in adopting guidelines. We also note that the scope of services 
in the managed care plan contract will determine the areas in which 
practice guidelines are appropriate.
    Comment: One commenter recommended that CMS clarify at Sec.  
438.236(c) that only general clinical practice guidelines will be made 
available to the public, as licensed and proprietary clinical criteria 
should not be available publicly unless such criteria is relevant to a 
specific treatment or service and is specifically requested by the 
enrollee, or the enrollee's health care provider, with appropriate 
notice of disclosure of confidential and proprietary information. One 
commenter recommended that CMS require all practice guidelines to be 
published publicly on each managed care plan's Web site.
    Response: We understand the commenter's concern regarding licensed 
and proprietary clinical criteria. We remind the commenter that Sec.  
438.236(c) requires each managed care plan to disseminate practice 
guidelines to all affected providers, and upon request, to enrollees 
and potential enrollees. We do not expect managed care plans to 
disseminate all of their practice guidelines widely (such as through 
public posting on a Web site), but we do expect that managed care plans 
make specific practice guidelines available to the applicable network 
providers (or out-of-network providers to whom the plan refers 
enrollees for covered services) for which such practice guidelines 
apply. We believe this is consistent with the general concept of having 
practice guidelines and assisting health care professionals to apply 
the

[[Page 27753]]

best evidence-based practice to clinical care. We maintain that Sec.  
438.236(c) is an appropriate minimum standard for the dissemination of 
practice guidelines to affected providers, potential enrollees, and 
enrollees; therefore, we decline to require that practice guidelines be 
published on each managed care plan's Web site.
    Comment: One commenter recommended that CMS include requirements at 
Sec.  438.236(d) for managed care plans to provide the applicable 
practice guidelines in all prior authorization denials to the 
requesting health care provider and the enrollee.
    Response: We do not agree with commenters that Sec.  438.236(d) 
should be revised to require managed care plans to provide the 
applicable practice guideline with all prior authorization denials to 
the requesting health care providers and enrollees. The managed care 
plan's denial of a prior authorization request may be based on coverage 
criteria other than the practice guidelines; therefore it is not 
appropriate to require the inclusion of practice guidelines with 
denials of prior authorization requests. In addition, this 
recommendation is duplicative of existing requirements at Sec.  
438.236(c) that the managed care plan provide practice guidelines to 
affected providers and the content of the managed care plan's notice of 
an adverse benefit determination at Sec.  438.404(b)(2).
    After consideration of the public comments, we are not amending 
Sec.  438.236.
9. Definitions and Technical Corrections
a. Definitions
    We proposed to redesignate and add several definitions to Sec.  
438.2 in connection with changes we proposed to specific sections and 
subparts. In addition, we proposed several modifications and additions 
to Sec.  438.2 to address terms used throughout this part. In Sec.  
438.2 we proposed to modify existing definitions for ``comprehensive 
risk contract,'' ``health care professional,'' ``health insuring 
organization,'' ``managed care organization,'' ``nonrisk contract,'' 
``prepaid ambulatory health plan,'' ``prepaid inpatient health plan,'' 
and ``risk contract.'' In addition, we proposed to add definitions for 
``managed care program,'' ``network provider,'' and ``state,'' which 
are terms used with some frequency in part 438 but are not currently 
defined.
    For the existing definition of a ``comprehensive risk contract'' we 
proposed to add that the contract is ``between the State and an MCO'' 
to make clear that only MCOs can have comprehensive risk contracts and 
to identify the parties to the contract.
    We received the following comments in response to the proposed 
changes to the definition of ``comprehensive risk contract.''
    Comment: A few commenters requested revisions to the definition for 
a comprehensive risk contract; specifically, commenters requested the 
addition of freestanding birth centers or LTSS to the list of services 
that could be covered by an MCO contract. Another commenter requested 
clarification if the revised definition to clarify that a comprehensive 
risk contract is between the state and an MCO has any impact on the 
contractual relationship the state has with PIHPs or PAHPs.
    Response: We decline to add additional types of services to the 
definition of a comprehensive risk contract because the services 
covered under a comprehensive risk contract with a MCO are specified in 
statute at section 1903(m)(2)(A) of the Act. The revision to the 
definition of a comprehensive risk contract was merely to clarify the 
parties to the arrangement. Since we use the term ``risk contract'' to 
apply to all types of those contracts and do not use a term specific to 
a limited or non-comprehensive contract with a PIHP or PAHP, we clarify 
here for the commenter that for states that contract with PIHPs and 
PAHPs, the parties to the contract would be the state and the PIHP or 
PAHP.
    After consideration of comments, we are finalizing the definition 
of ``comprehensive risk contract'' as proposed.
    We proposed to revise the definition for ``health care 
professional'' to include language from the statutory definition that 
the physician's or provider's services are covered under the contract 
and to clarify that providers of services other than medical services, 
such as LTSS, would be included in this definition. We also proposed to 
delete the list of professionals in section 1932(b)(3)(C) of the Act 
from our regulatory definition of ``health care professional'' because 
the list was not intended to be exclusive and inclusion of this list in 
the regulatory definition does not clarify our intent for this 
definition. We requested comment on this approach.
    We received the following comments on the definitions and use of 
``health care professional'' and ``provider.''
    Comment: Several commenters were supportive of the proposed 
modification to the definition of ``health care professional'' that 
would remove the list of specific provider types from section 
1932(b)(C)(3) of the Act and clarify that the term encompasses any 
provider whose services are covered under a managed care contract. 
Another commenter recommended that CMS clarify in the definition that 
such health care professionals must be appropriately credentialed. 
Other commenters suggested that CMS explicitly acknowledge behavioral 
health providers that are certified but not licensed, nurse 
practitioners, and providers of LTSS in the definition. Another 
commenter recommended that the definition be based on the work done by 
the individual, rather than their degree or title. We also received 
comments questioning our use of the term ``provider'' but not defining 
it in this part.
    Response: In consideration of these comments, we have decided not 
to retain ``health care professional'' and instead, simplify our usage 
of terminology and use ``provider'' and ``network provider'' in part 
438, except in Sec.  438.210(b)(3), where we finalize the regulation 
with the term ``individual.'' We believe that the existing definition 
of ``provider'' in Sec.  400.203 generally addresses our intent in the 
term ``health care professional.'' Based on Sec.  400.203, we will 
define ``provider'' as ``any individual or entity that is engaged in 
the delivery of services, or ordering or referring for those services, 
and is legally authorized to do so by the state in which it delivers 
the services'' for purposes of part 438. This definition is broad 
enough to address all services under the contract without the need to 
maintain a specific list of specialties and is not based on title or 
degree. We have chosen not to incorporate the term ``health care 
services'' in the definition of ``provider'' for consistency with our 
efforts throughout part 438 to reflect the broader range of services 
covered in managed care, including LTSS. We believe this new definition 
clarifies our intent while enhancing consistency with other parts.
    To the comment that recommended that a reference to 
``credentialing'' be added, we appreciate the opportunity to clarify. 
Credentialing is included in the process of being a network provider 
and we are retaining ``network provider'' in this part. Therefore, 
there is no need to add a reference to credentialing to any other 
definition.
    Comment: We received a comment requesting that CMS clarify whether 
or not the applicable definition of the term ``provider'' is the same 
as defined in Sec.  400.203.
    Response: We appreciate the opportunity to clarify the use of

[[Page 27754]]

``provider'' within part 438. As explained in the response to comments 
above on ``health care professional,'' we will be adopting ``provider'' 
and define it as ``any individual or entity that is engaged in the 
delivery of services, or ordering or referring for those services, and 
is legally authorized to do so by the State in which it delivers the 
services.'' We will add this to Sec.  438.2 and use the term, as 
appropriate, throughout part 438.
    Comment: The definition for ``health care professional'' should not 
include providers of all services other than medical services. In these 
proposed regulations, a health care professional can render coverage 
and medical necessity decisions, as in Sec.  438.210. 
Non[hyphen]medical, unlicensed persons and paraprofessionals, such as 
providers of personal care services and NEMT providers, cannot render 
these types of decisions.
    Response: We appreciate the opportunity to clarify Sec.  438.210. 
The reference to ``health care professional'' in Sec.  438.210(b)(3) 
was not intended to reference an in-or-out of network provider, but 
rather an employee or contractor of the managed care plan that renders 
authorization decision for the managed care plan. To make our intent 
clearer, we will replace ``health care professional'' with 
``individual'' in Sec.  438.210(b)(3). We believe that states and plans 
make every effort to select individuals with appropriate expertise and 
training for authorization decision making functions and that the use 
of ``individual'' reflects that flexibility. Additionally, paragraph 
(b)(3) sets a minimum standard; states are free to include additional 
specificity through the managed care plan contract.
    Therefore, we have added a definition for ``provider'' in Sec.  
438.2 and are not finalizing the definition of ``health care 
professional.'' As a result of this, we are replacing proposed uses of 
``health care professional'' throughout part 438 with the terms 
``provider,'' ``network provider,'' or ``individual'' (specifically in 
Sec.  438.210) as appropriate.
    In the existing definition of a ``health insuring organization,'' 
we proposed to correct a technical error to the citation to the Omnibus 
Budget Reconciliation Act of 1985 from ``section 9517(e)(3)'' to 
``section 9517(c)(3)'' and update the reference to statutes that have 
since amended the HIO-related provisions established in the 1985 
statute. We did not receive comments on the definition of an HIO and 
will finalize as proposed.
    In the existing definition of a ``managed care organization'' we 
proposed to clarify, consistent with section 1903(m) of the Act that 
the Secretary determines if the conditions specified are met by an 
entity seeking to qualify for a comprehensive risk contract. The 
existing language does not identify who makes such a determination. We 
did not receive comments on the definition for a ``managed care 
organization'' and will finalize as proposed.
    In the proposed definition of a ``nonrisk contract,'' we proposed 
language to clarify that such a contract is between the state and a 
PIHP or PAHP. This proposed revision was consistent with the proposed 
change to identify the parties subject to a ``comprehensive risk 
contract.'' We proposed to remove ``medical'' as the modifier for 
``services'' in the definitions for ``prepaid ambulatory health plan'' 
and ``prepaid inpatient health plan'' because managed care plans may 
cover non-medical services such as LTSS. We also proposed to remove 
``agency'' that follows ``state'' consistent with our proposal to add a 
definition for ``state'' as meaning the single state agency as 
specified in Sec.  431.10. We did not receive comments on the proposals 
related to the definitions for ``nonrisk contract,'' ``comprehensive 
risk contract,'' ``prepaid ambulatory health plan,'' ``prepaid 
inpatient health plan,' and ``state,'' and will finalize as proposed.
    In the existing definition of a ``risk contract,'' we proposed to 
clarify that such a contract is between the state and MCO, PIHP or 
PAHP. This proposed revision is consistent with the proposed change to 
identify the parties subject to a ``comprehensive risk contract.'' We 
did not receive comments on the proposed modification to the definition 
of a ``risk contract'' and will finalize as proposed.
    We proposed to add a definition for the phrase ``managed care 
program,'' which is currently used in several sections of this part. We 
proposed this term to mean a managed care delivery system operated by a 
state as authorized under sections 1915(a) or (b), 1932(a), or 1115(a) 
of the Act. We did not receive comments on the proposed addition of a 
definition for a ``managed care program'' and will finalize as 
proposed.
    We proposed to add a definition for ``network provider.'' We 
intended this term to include all types of providers, either as an 
individual or through a group, and entities that order, refer, or 
render covered Medicaid services as a result of the state's arrangement 
with an MCO, PIHP, or PAHP. We also proposed to insert ``network 
provider'' in place of ``affiliated provider'' as used in this part for 
consistency in use of terminology. We received the following comments 
on the definition of ``network provider.''
    Comment: A few commenters noted that the proposed definition of 
``network provider'' includes any provider that receives funding 
directly or indirectly, which would include out-of-network providers, 
and that including non-participating providers as network providers 
also has unintended consequences, such as including all non-
participating providers in the MCOs provider directory. The commenters 
suggested that CMS define network provider to include only those 
providers under contract, and in specific areas, add reference to non-
participating providers where the intent is to include them.
    Response: We agree with the commenter as it was not our intention 
to include non-participating (or out-of-network) providers under the 
definition of ``network provider.''
    After consideration of public comments, we are finalizing the 
definition of ``network provider'' to clearly reflect that this term 
only applies to a provider that has a provider agreement with a managed 
care plan or a subcontractor of the managed care plan. To avoid any 
ambiguity, it is important to add subcontractor of a managed care plan 
because providers that have a provider agreement with a subcontractor 
of a managed care plan to order, refer, or render covered services are 
receiving Medicaid funding indirectly by virtue of the state's contract 
with the managed care plan. Additionally, we are removing ``health care 
professional'' from this definition and replacing it with ``provider'' 
as discussed above in section I.B.9.a. In addition, we will replace the 
word ``contract'' with ``provider agreement'' and delete ``managed care 
plan'', as that term is not defined, and insert ``MCO, PIHP, or PAHP.''
    We received the following comments to add or modify other 
definitions in Sec.  438.2.
    Comment: A few commenters recommended that CMS add a definition for 
ACO under 42 CFR part 438.
    Response: As discussed in the proposed rule at 80 FR 31163, states 
contracting with ACOs under the Medicaid program are outside of the 
purview of this final rule and are not bound by 42 CFR part 438. We 
decline to define ACOs for Medicaid programs as this is not within the 
scope of this rule.
    Comment: A few commenters recommended adding a definition for 
preventive health services, including but not limited to the health 
services

[[Page 27755]]

with a grade of A or B from the United States Preventive Services Task 
Force (USPSTF), in the general definitions of the proposed rule to 
harmonize it with the requirements of the Affordable Care Act.
    Response: The provisions related to preventive health services in 
the Affordable Care Act do not specifically apply to Medicaid managed 
care, and therefore, we do not believe it is appropriate to include a 
definition for preventive health services in part 438. See also our 
discussion in I.B.8.e.
    Comment: One commenter supported the addition of the services of 
``other licensed practitioners'' to the definition of ``primary care.'' 
As the health care system evolves and primary care services are 
provided by different types of health care professionals, the commenter 
stated that it is necessary that the Medicaid managed care system be 
modernized to reflect this reality.
    Response: We appreciate the commenter's support of the revision to 
the definition of ``primary care'' at Sec.  438.2. We acknowledge here 
that we neglected to describe this proposed change in the preamble but 
included in the proposed regulation text at 80 FR 31255. We originally 
proposed this revision for the reasons identified by the commenter.
    After consideration of the public comments, we are finalizing the 
definition of ``primary care'' as proposed without modification.
    Comment: One commenter noted that the terms ``enrollee'' and 
``beneficiary'' appear to be used interchangeably in the proposed rule 
and asked for clarification as to whether these terms are synonymous.
    Response: We appreciate the opportunity to clarify the meaning of 
these terms. An ``enrollee'' is a Medicaid beneficiary that is enrolled 
in a managed care plan. The term is used in the regulatory context when 
an individual's enrollment into a managed care plan affords certain 
rights or obligations. Generally speaking for purposes of this rule, 
``beneficiary'' is a Medicaid eligible individual that is not enrolled 
with a managed care plan but is also used in the managed care context 
to address individuals that are potential enrollees or enrollees. For 
example, the Beneficiary Support System is available to both potential 
enrollees and enrollees but the usage of both terms in the title of 
that system would unnecessarily complicate the title.
    Comment: One commenter recommended that CMS adopt the following 
definition of ``telemedicine'': ``Telemedicine or Telehealth'' means 
covered health care services provided to a covered person from a health 
care professional who is at a site other than where the covered person 
is located using telecommunications technology.''
    Response: We appreciate the commenter's suggestion but decline to 
add a definition for ``telemedicine'' because, while we have included 
telemedicine in Sec.  438.68(c)(1)(ix), we believe that the term has a 
generally accepted definition that is sufficient for purposes of that 
regulation.
b. Technical Corrections
    We proposed to correct a limited number of technical and 
typographical errors identified in the June 14, 2002 final rule and the 
October 25, 2002 correcting amendment, as well as those identified 
through our review of the existing regulations in part 438.
     We proposed to update the cross-reference to cost-sharing 
rules in Sec.  438.108 to reflect recent revisions to part 447.
     For purposes of consistency throughout part 438, we 
proposed to remove specific references to our Regional Office in Sec.  
438.806(a)(1) and replace it with a general reference to CMS. This 
proposed change does not represent a modification in the role of the 
Regional Offices; rather, we would prefer to establish workflow 
processes in sub-regulatory guidance rather than in regulation.
     We proposed to delete Sec.  438.804 related the primary 
care provider payment increase under section 1202 of the Affordable 
Care Act as that provision expired at the close of CY 2014.
    We did not receive comments on the proposed technical corrections 
and will finalize those changes as proposed.
c. Applicability and Compliance Dates
    To clarify the applicability and compliance dates of various 
sections in this final rule, we are also finalizing new regulations 
text, consistent with the statement on applicability and compliance in 
the Effective Dates and Supplementary Information of this rule, in the 
following sections: Sec. Sec.  438.3(v), 438.10(j), 438.62(c), 
438.66(f), 438.206(d), 438.207(f), 438.208(d), 438.210(f), 438.230(c), 
438.242(e), 438.310(d), 438.400(c) and 438.600(c). We are also changing 
the name of Sec. Sec.  438.400 and 438.600 to account for the addition 
of regulation text on applicability and compliance dates for those 
provisions.

II. CHIP Requirements

A. Background

    ARRA, CHIPRA and the Affordable Care Act made applicable to CHIP 
several Medicaid managed care provisions in section 1932 of the Act, 
including section 1932(a)(4), Process for Enrollment and Termination 
and Change of Enrollment; section 1932(a)(5), Provision of Information; 
section 1932(b), Beneficiary Protections; 1932(c), Quality Assurance 
Standards; section 1932(d), Protections Against Fraud and Abuse; and 
section 1932(e), Sanctions for Noncompliance. In addition, the 
Affordable Care Act made applicable to CHIP and sections 1902(a)(77) 
and 1902(kk) of the Act related to provider and supplier screening, 
oversight, and reporting.
    This rule implements these statutory provisions and builds on 
initial guidance on the implementation of section 403 of CHIPRA 
(section 2103(f) of the Act) provided in State Health Official (SHO) 
letters 09-008 and 09-013, issued on August 31, 2009 and October 21, 
2009, respectively and codifies our policies. (SHO #09-008 is available 
at http://downloads.cms.gov/cmsgov/archived-downloads/SMDL/downloads/SHO083109a.pdf. SHO #09-013 is available at http://www.medicaid.gov/Federal-Policy-Guidance/downloads/SHO102109.pdf.) The SHO letters 
explained that the requirements of section 2103(f) of the Act, as 
amended by section 403 of CHIPRA effective July 1, 2009, apply to all 
CHIP managed care contracts. The provisions in this final rule both 
reflect and supersede this earlier guidance.
    Our overarching goal for these regulations is to align CHIP managed 
care standards with those of the Marketplace and Medicaid where 
practical to ensure consistency across programs. As discussed in 
section I of the preamble, in this final rule, we are revising existing 
Medicaid regulations in order to modernize managed care contracting and 
service delivery while improving health care outcomes and beneficiary 
experience in a cost effective manner. To the extent appropriate, the 
final regulations for CHIP are aligned with the revisions made for 
Medicaid.
    We recognize that CHIP has historically had few regulations related 
to managed care. To that end, we proposed to apply the requirements of 
section 2103(f) of the Act in a manner that is consistent with the goal 
of aligning CHIP managed care with Marketplace and Medicaid managed 
care rules, without imposing any additional requirements. We similarly 
address provisions of section 1932 of the Act applicable to CHIP under 
section 2107(e)(1)M) of the Act, and certain program integrity 
authorities applicable to CHIP under section 2107(e)(1)(D) of the Act 
with the goal of

[[Page 27756]]

alignment between programs without imposing significant new burdens on 
CHIP. Thus, the scope of the CHIP regulations is narrower than the 
revisions and amendments to the Medicaid managed care regulations. Most 
of the proposed CHIP regulatory changes are limited in scope to those 
areas specified in statute and, to the extent possible, those changes 
that will align the program with Medicaid and Marketplace regulations.

B. Summary of Proposed Provisions and Analysis of and Responses to 
Comments

    In the June 1, 2015 proposed rule (80 FR 31169 through 31175), we 
proposed to implement provisions of the Children's Health Insurance 
Program Reauthorization Act of 2009 (CHIPRA) related to managed care.
    We proposed adding a new subpart L to part 457 related to CHIP 
managed care plans. Most of the proposed regulations in this subpart 
are new, however we also proposed to move portions of Sec.  457.940 and 
Sec.  457.950 and all of Sec.  457.955 from subpart I to the new 
subpart. This was to ensure that all information related to managed 
care would be contained in one subpart. We proposed to make revisions 
to Sec.  457.204 related to FFP. In addition, we proposed to revise 
Sec.  457.760 related to Strategic Planning, Reporting, and Evaluation.
    Below we summarize the proposed provisions related to CHIP, as well 
as the public comments we received, and our responses to the comments. 
Comments related to the paperwork burden and the impact analyses are 
addressed in the ``Collection of Information Requirements'' and 
``Regulatory Impact Analysis'' sections in this final rule.
1. Definitions (Sec. Sec.  457.10, 457.902)
    We proposed to move the definitions of ``fee-for-service entity'' 
and ``actuarially sound principles'' in Sec.  457.902 to Sec.  457.10, 
to delete Sec.  457.902 and to add new definitions of various terms 
used elsewhere in the proposed regulations for CHIP, including 
comprehensive risk contract, EQR, EQR organization, MCO, prepaid 
ambulatory health plan, prepaid inpatient health plan, primary care 
case management, primary care case management entity, PCCM, and risk 
contract.
    Comment: One commenter requested that we add freestanding birth 
centers and doula and other community health worker agencies to the 
definition of a comprehensive risk contract in Sec.  457.10
    Response: We decline to add additional types of services to the 
definition of a comprehensive risk contract in order to maintain 
alignment between the definition of a comprehensive risk contract in 
CHIP with the definition in Medicaid. Discussion of the Medicaid 
definition of comprehensive risk contract can be found in section 
I.B.9.a of this preamble.
    We have added definitions for ``federally qualified HMO'' and 
``provider'' to further align with the Medicaid regulatory language and 
made revisions to the definition of ``managed care organization'' to 
remove references to advanced directives as there are very few adults 
in CHIP and very few children need an advanced directive. After 
consideration of the public comments, we are finalizing Sec. Sec.  
457.10 and 457.902 as proposed with these stated additions and 
revisions.
2. Federal Financial Participation (Sec.  457.204)
    We proposed to revise Sec.  457.204(a) to expand the regulatory 
statement of when we may withhold FFP to make clear that non-compliance 
can be based on a finding by the CMS Administrator that the state plan 
or state practice is in substantial non-compliance with the regulations 
in part 457 that implement Title XXI of the Act. In addition, we 
proposed to explicitly provide that substantial non-compliance 
includes, but is not limited to, failure to comply with requirements 
that significantly affect federal or state oversight or state 
reporting.
    We received the following comments in response to our proposal to 
revise Sec.  457.204.
    Comment: Several commenters encouraged CMS to withhold FFP when a 
CHIP managed care entity is in substantial non-compliance with the 
state plan.
    Response: Federal regulations do not directly regulate the CHIP 
managed care entities with which states contract. The regulations set 
out requirements and standards for States, including contracting 
standards and oversight responsibilities for the MCOs, PIHPs, PAHPs, 
PCCMs, and PCCM entities participating in the state's CHIP. The revised 
language of Sec.  457.204 would authorize compliance actions when a 
state fails to comply with its oversight responsibilities under these 
regulations with respect to a managed care contract.
    To streamline Sec.  457.204 and make clear that compliance includes 
meeting requirements for state oversight, we are moving the definition 
of substantial noncompliance, which we proposed to include in 
paragraphs (a)(1) and (a)(2) to a separate (a)(3). After consideration 
of the public comments, we are making no additional changes to Sec.  
457.204.
3. Basis, Scope, and Applicability (Sec.  457.1200)
    In Sec.  457.1200, we described the statutory basis and scope of 
proposed subpart L. Specifically, we proposed to implement the 
requirements expressly set forth in section 2103(f)(3) of the Act, as 
added by section 403 of CHIPRA, which applies sections 1932(a)(4), 
1932(a)(5), 1932(b), 1932(c), 1932(d), and 1932(e) of the Act to CHIP; 
section 2107(e)(1)(M) of the Act, as added by section 5006 of the 
American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5, ARRA), 
which applies sections 1932(a)(2)(C) and 1932(h) of the Act, relating 
to protections for American Indians, to CHIP. We also proposed to 
implement statutory provisions related to program integrity, 
specifically sections 2107(b) and 2107(e)(2)(C) through (E) of the Act. 
Finally, the proposed regulations also rely on section 2101(a) of the 
Act, which provides that the purpose of Title XXI is to provide funds 
to states to enable them to initiate and expand the provision of child 
health assistance to uninsured, low-income children in an effective and 
efficient manner.
    Comment: Commenters were supportive of the scope of the regulations 
and did not make any suggested revisions
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing Sec.  
457.1200 as proposed.
4. Contracting Requirements (Sec. Sec.  457.950, 457.1201)
    Previously, all CHIP contracting requirements, including managed 
care contracting requirements, were included in Sec.  457.950. We 
proposed to move some provisions of Sec.  457.950 related to managed 
care into new Sec.  457.1201 and to eliminate others. We also proposed 
new contracting standards in Sec.  457.1201. In some cases, we proposed 
CHIP-specific contracting requirements; in other cases, we proposed to 
adopt the Medicaid standards in Sec.  438.3. The proposed CHIP-specific 
provisions at Sec.  457.1201(a) would have states submit CHIP managed 
care contracts in accordance with standards that will be specified by 
the Secretary. We did not propose to condition FFP on CMS' prior 
approval of CHIP managed care contracts. This would have diverged from 
the proposed Medicaid regulations at Sec. Sec.  438.3 and 438.806, 
providing increased flexibility for states under CHIP while still 
retaining a role for federal oversight.
    Although we did not propose to adopt Medicaid rules related to rate 
review,

[[Page 27757]]

the proposed Sec.  457.1201(a) requires that CHIP contracts submitted 
to CMS include the rate that will be paid to the managed care entity.
    There are several standards at Sec.  438.3 that we did not propose 
to adopt in CHIP, either because we do not have clear authority or 
because we wished to maintain flexibility, or because they are not 
appropriate for the CHIP population.
    We received the following comments on the proposed revisions to 
Sec.  457.950 and on proposed new Sec.  457.1201.
    Comment: Several commenters expressed support for the alignment of 
Medicaid and CHIP contract provisions as proposed. Other commenters 
recommended that CMS apply additional Medicaid provisions to CHIP. 
Specifically, commenters suggested that CMS fully align CHIP with the 
Medicaid contracting rules in proposed Sec.  438.3(q)(4) through 
(q)(5)(related to contracting with PCCMs) and Sec.  438.3(r) (related 
to contracting with PCCM entities).
    Response: We agree with commenters that the contracting rules in 
proposed Sec.  438.3(q)(4) through (q)(5) should apply to CHIP. In 
Sec.  457.1201(l), we proposed to adopt the standards in Sec.  
438.3(q)(1) through (q)(3). The proposed rule omitted the cross 
reference to the standards in paragraphs (q)(4), which specifies that 
the contract must prohibit discrimination in enrollment, disenrollment, 
and reenrollment based on the beneficiary's health status or need for 
health care services, and (q)(5), which provides that enrollees have 
the right to disenroll in accordance with Sec.  438.56(c). This was an 
oversight, and we are including cross references to all of 438.3(q) in 
the final rule. Note that existing regulations at Sec.  457.480 already 
prohibit states from imposing any exclusion for covered services for 
pre-existing conditions, and Sec.  438.56(c) also is applied to CHIP 
via cross reference at Sec.  457.1212 of the final rule. Section 
438.3(r) provides that contracts with PCCM entities that provide for 
shared savings must comply with Sec.  438.330(b)(2), (b)(3), (c), and 
(e), Sec.  438.340, and Sec.  438.350. These provisions are 
incorporated into the final regulations for CHIP via cross-reference at 
Sec.  457.1240(b), (e), and (f). Rather than cross-referencing to Sec.  
438.3(r), in proposed Sec.  457.1201(m), re-designated at Sec.  
457.1201(n) of the final rule, provides that, if contracts with PCCM 
entities provide for shared savings, incentive payments or other 
rewards for quality outcomes, the contracts must comply with Sec.  
457.1240(b), (e), and (f).
    Comment: Commenters also requested that CMS adopt for CHIP proposed 
Sec.  438.3(e) (related to services that may be covered), Sec.  
438.3(g) (related to provider-preventable conditions), and Sec.  
438.3(s)(1), (4), (5) and (6) (related to outpatient drugs) because 
they believe that these provisions would provide valuable information 
about program operations. In particular, commenters expressed concern 
that exclusion of Sec.  438.3(e) could be interpreted as prohibiting 
CHIP enrollees from receiving services that an MCO voluntarily 
provides. The commenters request clarification that CHIP enrollees will 
be able, at the state's option, to receive services voluntarily 
provided by MCOs. They recommended adopting Sec.  438.3(e) to give 
states the option to require continuation of voluntarily provided 
services.
    Response: We agree with commenters that MCOs are not precluded from 
providing additional services, and that the terms of Sec.  438.3(e) are 
equally applicable to CHIP; we did not intend to imply that CHIP 
enrollees would be prohibited from receiving services that an MCO 
provides voluntarily. While we do not believe that it is necessary to 
expressly allow MCOs, PIHPs, and PAHPs to provide services that are not 
required under the state plan, we agree that it is confusing to have a 
stated standard in Medicaid and omit it in CHIP. In addition, Sec.  
438.3(e) provides clarity to states about what may be included in the 
capitation rate.
    However, we do not agree with commenters that we should adopt the 
standards in Sec.  438.3(g) and Sec.  438.3(s)(1), (4), (5) and (6). 
Section 438.3(g) refers to Sec.  447.26, which prohibits payment for 
provider-preventable conditions as required by section 2702 of the 
Affordable Care Act. Section 2702 of the Affordable Care Act does not 
apply to CHIP and we did not propose to exercise rulemaking authority 
to make it applicable to CHIP. While we encourage states to apply a 
prohibition on payments for provider-preventable conditions, we are not 
requiring it at this time. Similarly, Sec.  438.3(s)(1), (4), and (5) 
refer to standards related to outpatient drugs in section 1927 of the 
Act. Section 1927 of the Act does not apply to CHIP, we did not propose 
to make it applicable, and we are not imposing these standards to CHIP 
managed care entities at this time.
    Comment: One commenter expressed concern that the proposed 
standards for LTSS as outlined in Sec.  438.3(o) and the standards for 
enrollees who are patients in an IMD proposed at Sec.  438.3(t) 
(finalized elsewhere in this final rule at Sec.  438.6(e)) are not 
included in this section. The commenter recommends that CMS apply the 
standards proposed for Medicaid to CHIP so enrollees with special 
health care needs who do not meet the SSI criteria for disability can 
benefit from these services.
    Response: We do not agree that adopting these standards in CHIP is 
appropriate. Section 438.3(o) requires that home and community based 
services which are provided by a Medicaid MCO, PIHP or PAHP that could 
be authorized under sections 1915(c), 1915(i), or 1915(k) of the Act be 
delivered in a setting which satisfies the requirements of Sec.  
441.301. There are no comparable statutory or regulatory provisions 
relating to provision of home and community based services for children 
eligible for a separate CHIP. Similarly, the IMD provision finalized at 
Sec.  438.6(e) sets out standards for capitation payments to MCOs and 
PIHPs for enrollees with a short-term stay in an IMD. The exclusion of 
FFP for care provided to patients in an IMD in paragraph (B) following 
section 1905(a)(29) of the Act and Sec.  435.1010 of the Medicaid 
regulations does not apply to CHIP (while status as a patient in an IMD 
is relevant to an eligibility determination, there is no preclusion of 
coverage for IMD or other services for an individual who has been 
determined eligible).
    Comment: Several commenters requested that CMS provide sub-
regulatory guidance to states to ensure compliance with new 
requirements.
    Response: We intend to provide guidance to states regarding the new 
regulations.
    Comment: Some commenters expressed support for CMS' approach to 
contract review for CHIP, which would not condition FFP on prior 
approval of contracts. One commenter acknowledged that CHIP may need to 
be treated differently than Medicaid due to statutory constraints and 
difference in program structure. However, several commenters 
recommended that CMS follow Medicaid by conditioning FFP on timely 
submission and prior approval of contracts. In addition, several 
commenters suggested that CMS coordinate the timing of submissions with 
the Medicaid review and submission schedule, specifically requesting 
that CMS require submission 90 days prior to the effective date of 
contracts. In addition, several commenters requested that CMS allow a 
single contract review process for states with separate and combination 
CHIP programs.
    In contrast, some commenters expressed concern that the proposed 
contract submission requirements could cause administrative burden for 
states. One commenter stated that if the

[[Page 27758]]

provisions are adopted as proposed, CMS should only apply the 
submission requirements to future contracts rather than to the renewals 
of current contracts.
    Response: We appreciate the comments on this topic. We believe 
having states submit the contracts, including the capitation rates, but 
not conditioning FFP on prior approval, strikes the appropriate balance 
for CHIP. As we discussed in the proposed regulation, we believe this 
approach, over time, will give CMS and the public important information 
about the administration of CHIP. Once we have learned more, we may 
consider adopting additional standards (including conditioning FFP on 
prior approval of contracts) or providing guidance on best practices 
for managed care contracting. We intend to specify standards for 
submission of the contracts in sub regulatory guidance.
    Comment: A few commenters expressed concern that the requirement at 
proposed Sec.  457.1201(j) that CHIP plans submit annual audited 
financial reports may increase costs for the plans. Commenters 
requested clarification in Sec.  457.1201(j) that audited financial 
reports are not required to be specific to the Medicaid and/or CHIP 
experience only. Several commenters recommended that CMS accept 
submission of alternative CEO/CFO assured or certified reports.
    Response: Proposed Sec.  457.1201(j), finalized at Sec.  
457.1201(k) of this final rule, requires the MCO, PIHP, or PAHP submit 
annual audited financial reports specific to the CHIP contract(s). 
Submission of alternative certified reports is not permitted under the 
regulation. We disagree that audited financial reports, which will help 
to ensure states that plans are operating in accordance with federal 
requirements, will impose undue costs on plans.
    Comment: One commenter stated that audits of MCOs, PIHPs, and PAHPs 
should be conducted in compliance with the generally accepted auditing 
standards as opposed to the generally accepted auditing principles.
    Response: We agree that managed care plans must submit audited 
financial reports on an annual basis in accordance with generally 
accepted accounting principles as well as generally accepted auditing 
standards. As finalized, Sec.  457.1201(k) cross-references Sec.  
438.3(m), which requires both standards.
    Comment: Several commenters stated that the record retention and 
audit standards were unclear and suggested that that CMS clarify and 
align recordkeeping and audit standards so that Medicaid managed care 
plans clearly understand their obligations. One commenter supported the 
6-year minimum recordkeeping requirement, but recommended that CMS 
adjust the audit and inspection timeline so that Medicaid managed care 
plans maintain records that may be required in an audit or inspection. 
Some commenters recommended that CMS align the timeframes for records 
retention across the regulation by extending the records retention 
requirements proposed at Sec.  457.1201(p) (finalized at Sec.  
457.1201(q)) for MCOs, PIHPs and PAHPs to a period of no less than 10 
years.
    Response: We agree with commenters that the recordkeeping 
requirements should align throughout the regulation. Medicaid is 
updating the record retention requirement in Sec.  438.3 to 10 years to 
align with Sec.  438.230(c)(3)(iii), the False Claims Act at 31 U.S.C. 
3731(b)(2), and MA. Therefore, we believe it is appropriate to align 
Sec.  457.1201 with the 10 year requirement. We are modifying the 
regulatory text to adopt this recommendation.
    After consideration of the public comments, we are:
     Revising paragraph (h) (redesignated as paragraph (i)).
     Revising paragraph (j) (redesignated as paragraph (k)).
     Clarifying the cross-references in paragraph (n) related 
to additional rules for contracts with PCCM entities; and
     Modifying the record retention standard in Sec.  
457.1201(q).
    To streamline the regulatory language and better align with the 
requirements set forth in Medicaid, we also are:
     Making minor editorial revisions to paragraphs (a), (b), 
and (c);
     Adding paragraph (e), related to services that may be 
covered by an MCO, PIHP, or PAHP;
     Redesignating the paragraphs following paragraph (e);
     Updating the cross-references in paragraph (f) (related to 
additional rules for contracts with PCCMs; and
     Updating the paragraphs of Sec.  457.1201 to cross-
reference the Medicaid definitions in Sec.  438.3 in order to 
streamline the regulation text where appropriate.
    Other than redesignation, we are finalizing paragraphs (o) and (p) 
as proposed.
5. Rate Development Standards and Medical Loss Ratio (Sec. Sec.  
457.940, 457.1203, 457.1205)
    Currently, regulations related to CHIP managed care rate setting 
are in Sec.  457.940(b)(2), (c), and (e). We proposed to move those 
standards to new Sec.  457.1203. The standards would remain 
substantively unchanged, although we proposed to change the term 
``principles of actuarial soundness'' to ``actuarially sound 
principles,'' to match the term defined in Sec.  457.902, which we 
proposed to move to Sec.  457.10. We did not propose to change or move 
the standards unrelated to managed care rate setting in Sec.  
457.940(a), (b)(1), and (d). In addition, to align with the private 
market and the Medicaid managed care proposal at Sec.  438.4(b)(9) 
(related to medical loss ratio)), we proposed at Sec.  457.1203(c) to 
adopt an MLR calculation and reporting requirement in CHIP and to 
require rates to be developed to meet a target MLR. We believe MLR 
calculation and reporting are important tools to ensure that the CHIP 
program is administered in an effective and efficient manner in 
accordance with section 2101(a) of the Act. We also proposed to align 
with the Medicaid proposed regulations at Sec.  438.8 and Sec.  438.74 
at Sec.  457.1203(c) in relation to MLR standards and state oversight.
    We did not propose to adopt any of the other Medicaid standards 
related to rate development (Sec.  438.5), contract provisions related 
to payment (Sec.  438.6), or rate certification (Sec.  438.7).
    We received the following comments in response to our proposal to 
revise Sec.  457.940, and add Sec.  457.1203 and Sec.  457.1205.
    Comment: Many commenters supported the adoption of a minimum MLR in 
CHIP, and some supported the application of the MLR standards for 
Medicaid described in Sec.  438.4(b)(9) and Sec.  438.74. However, 
several commenters expressed a preference for using an 80 percent 
minimum MLR for CHIP, rather than the 85 percent minimum CMS proposed. 
They stated that at least one state currently uses an 80 percent 
minimum MLR in CHIP, while several states use an 85 percent minimum MLR 
in Medicaid. A few commenters suggested that we allow states to ask for 
an MLR adjustment to the minimum MLR for CHIP.
    Response: We appreciate commenters' support of adopting an MLR 
calculation and reporting requirement in CHIP and use of MLR reporting 
and projections as part of the rate setting process. We clarify, 
however, that this rule does not impose a minimum MLR requirement on 
CHIP (or Medicaid) managed care plans. Rather, the rule requires that 
rates be developed in a manner to meet a target MLR; a plan's failure 
to meet that target MLR does not result in violation of these 
regulations. The imposition of any penalty or consequence for failing 
to meet a specific minimum MLR is a

[[Page 27759]]

matter of state law and policy. MLR data reported by plans may also be 
used by states in establishing rates in subsequent contracts.
    We disagree with commenters that we should use a lower MLR as the 
target MLR used in rate development for CHIP. The 85 percent standard 
is consistent with both the Medicaid standard in Sec.  438.4(b)(9) and 
the large group private insurance market standard in 45 CFR 158.210. 
Some commenters suggested that because CHIP plans tend to have 
comparable administrative costs to Medicaid, but cover children with, 
on average, lower medical costs, the resulting medical to overall cost 
ratio is lower. We disagree that this will significantly affect rate 
development using a target MLR of 85 percent MLR. We believe that the 
same standard is an appropriate target MLR for CHIP plans, as most CHIP 
plans are large enough to distribute fixed administrative costs such 
that a comparable MLR can be achieved. Smaller plans may take advantage 
of the credibility adjustment in Sec.  438.8(h), effectively lowering 
their reported MLR. For similar reasons, we decline to allow states to 
ask for an MLR adjustment. We note that while 45 CFR 158.301 allows 
states to request an MLR adjustment, the adjustment is only for plans 
sold on the private individual insurance market. It is not applicable 
to either the large group or small group market, which are more 
comparable to CHIP. As noted, states are not required to take contract 
or enforcement action against a CHIP managed care plan if the plan 
reports an MLR which is less than 85 percent; that information can and 
should be considered in rate-setting for future years, as it may 
indicate that adjustments in capitation rates are necessary to meet the 
85 percent MLR target.
    Comment: Several commenters encouraged us to apply additional 
Medicaid provisions related to the establishment of capitation rates 
and other payment standards and methodologies for MCOs, PIHPs and PAHPs 
to CHIP, including all of Sec. Sec.  438.4, 438.5, 438.6, and 438.7. 
Commenters stated that, even without a statutory mandate to meet 
particular actuarial soundness requirements, CHIP rates should be 
actuarially sound and rates should be calculated according to widely 
accepted principles of actuarial science.
    Response: We agree that states must develop payment rates for MCOs, 
PIHPs, and PAHPs for CHIP using actuarially sound principles, as 
required under Sec.  457.1203(a) of the final rule. However, Title XXI 
does not provide the same specificity about rate development standards 
as Title XIX, and while we agree that we have authority under section 
2101 of the Act to establish additional standards, we have determined 
it would not be appropriate to impose all of the Medicaid rate-setting 
standards on separate CHIPs at this time including those cited by 
commenters. Per Sec.  457.1201 of the final rule, states are required 
to include payment rates in their managed care contracts submitted to 
CMS. As we gain additional experience with rate setting in CHIP, we may 
consider developing additional standards for CHIP in the future.
    Comment: One commenter asked CMS to clarify in Sec.  457.1203 that 
states have flexibility to implement and test reimbursement 
methodologies that pay for outcomes.
    Response: States have discretion under the regulations to 
incentivize and retain certain types of providers to participate in the 
delivery of care to CHIP beneficiaries, including under a managed care 
arrangement, and including use of outcome or value-based purchasing 
models. Managed care plans are a key partner in achieving the goals of 
improved population health and better care at lower cost, and we 
encourage states to partner with their managed care plans to achieve 
delivery system and payment reform and performance improvements. We 
agree with the commenter that the proposed regulation text was unclear 
and have clarified in Sec.  457.1203(a) that implementing value-based 
purchasing models for provider reimbursement is one mechanism states 
can use to enroll efficient and high quality providers.
    Comment: One commenter asked us to require in Sec.  457.1205 that 
states submit a summary description of the MLR reports received from 
the MCOs, PIHPs and PAHPs along with the actuarial certification.
    Response: We agree with the commenter that state submissions to CMS 
should include some information about the MLR, and that the language in 
proposed Sec.  457.1205 related to submission of the summary 
descriptions of the MLR reports was unclear. We intended to propose 
that states submit a summary description of the MLR reports, just as 
Medicaid agencies are required to do under Sec.  438.8(k), while 
acknowledging that the reports would not be submitted with the 
actuarial certifications described in Sec.  438.7 because such 
certifications are not required in CHIP. We are revising the language, 
finalized at Sec.  457.1203(e) of the final rule, to better reflect our 
intent.
    Comment: Many commenters referred us to their comments on proposed 
Sec.  438.4(b)(8) (related to developing rates to meet the minimum MLR 
and redesignated in this rule at Sec.  438.4(b)(9)) and Sec.  438.74 
(related to state oversight of the MLR) or made comments similar to 
those that were made on those regulations.
    Response: We refer commenters to the preamble discussion of Sec.  
438.4(b)(9) and Sec.  438.74 above for a more complete discussion of 
the comments we received on these provisions and our responses, which 
apply equally to CHIP.
    After consideration of the public comments, we are finalizing 
proposed Sec. Sec.  457.1203 and 457.1205 with modifications. First, we 
are moving the substance of the provisions of proposed Sec.  457.1205 
to Sec.  457.1203(e) and (f), and renaming this section ``Rate 
development standards and medical loss ratio'' to streamline the 
regulation text. In Sec.  457.1203, we are modifying the text in 
paragraph (a) to expressly provide that implementing value-based 
purchasing models for provider reimbursement is permitted. In paragraph 
(b), we are including the word ``or'' to clarify that a state may 
establish higher rates to assure sufficient provider participation or 
provider access or to enroll certain other providers. We are 
streamlining the text in paragraph (c). The language proposed in Sec.  
457.1205(a) (redesignated to Sec.  457.1203(e)) is revised to clarify 
that states must submit summary MLR reports but that these reports are 
not required to be submitted with the actuarial certification required 
for Medicaid described in Sec.  438.7.
6. Non-Emergency Medical Transportation PAHPs (Sec.  457.1206)
    States may use a PAHP structure to deliver NEMT services in CHIP, 
as is done in some states in Medicaid. As such, we proposed to adopt 
the Medicaid approach to regulating NEMT PAHPs, pursuant to which only 
certain provisions of the regulations would apply. However, under the 
proposed rule, if a state chooses to use a PAHP to provide NEMT 
services along with other ambulatory medical services, the PAHP is 
considered a traditional PAHP, as defined in Sec.  457.10, and all the 
PAHP provisions throughout subpart L of this part applicable to PAHPs 
generally would apply.
    At Sec.  457.1206, we proposed largely to mirror the terms of Sec.  
438.9, which sets out the standards that apply to PAHPs that provide 
only NEMT services in Medicaid, with two exceptions. First, proposed 
Sec.  457.1206 did not include standards related to advance directives 
or LTSS. Second, instead of requiring actuarial soundness, as is 
required

[[Page 27760]]

under Sec.  438.9(b)(2) by reference to Sec.  438.4, we proposed to 
require that NEMT PAHPs in CHIP follow the standards in Sec.  457.1203 
related to rate development.
    We received the following comments in response to proposed Sec.  
457.1206.
    Comment: Commenters noted that we did not propose to apply the 
advance directive and LTSS provisions in Sec.  438.9(b)(1)(ii)-(iii) 
(which cross references to Sec.  438.3(j) and Sec.  438.3(o)), and 
suggested that we reconsider. While they understand that these 
provisions may have limited applicability to the CHIP population, they 
believe there are some CHIP beneficiaries for whom these provisions 
would apply. In particular, they stated that children over age 18 and 
pregnant women would benefit from the advance directive provision and 
children with special health care needs would benefit from the LTSS 
provisions.
    Response: We do not agree that these standards should apply to 
CHIP. We believe that the advance directives provisions described in 
Sec.  438.3(j) and Sec.  422.128 would create a significant burden on 
states and MCOs, PIHPs, and PAHPs in the CHIP context, with 
correspondingly little benefit for beneficiaries, as there are very few 
adult beneficiaries in CHIP and very few children need an advance 
directive. As we explained in section II.A.4 of the preamble for the 
proposed rule, we do not believe the LTSS standards described in Sec.  
438.3(o) are appropriate for CHIP. Section 438.3(o) requires that home 
and community based services authorized for Medicaid beneficiaries 
under sections 1915(c), 1915(i), or 1915(k) of the Act which are 
provided by a Medicaid MCO, PIHP, or PAHP be delivered in a setting 
which satisfies the requirements of Sec.  441.301. There are no 
comparable statutory provisions relating to provision of home and 
community based services for children eligible for a separate CHIP.
    Comment: Commenters noted that there were several places that 
proposed Sec.  457.1206 deviated from Sec.  438.9. In particular, 
commenters noted that:
     Sec.  457.1206(b)(1)(ii) excluded audited financial 
reports, while there was no similar exclusion in Sec.  438.9 for NEMT 
PAHPs in Medicaid;
     Sec.  457.1206(b)(7) was not fully aligned with Sec.  
438.9(b)(7); and
     Sec.  457.1206 did not contain a reference to 
confidentiality provisions.
    They also noted a technical error in Sec.  457.1206(b)(1), in which 
they said we inadvertently referred to Sec.  457.1202 rather than Sec.  
457.1201.
    Response: We intended to align Sec.  457.1206 with all provisions 
in Sec.  438.9, with the exception of the standards related to advance 
directives and LTSS, discussed above. The confidentiality provisions in 
existing Sec.  457.1110 apply broadly to any entity that contracts with 
the state, including NEMT PAHPs, therefore we did not need to 
explicitly include a cross-reference to Sec.  457.1110 in Sec.  
457.1206. In addition to the discrepancies noted by commenters, we note 
that proposed Sec.  457.1206(b)(9) (related to the prohibition against 
affiliation with individuals debarred or excluded by federal agencies) 
was inadvertently broader than proposed Sec.  438.9(b)(9), in that 
Sec.  457.1206(b)(9) cross referenced to Sec.  457.1285 rather than to 
Sec.  438.610 (which is cross referenced in Sec.  438.9(b)(9)), and 
applied to CHIP via the cross reference to all of part 438 subpart H in 
Sec.  457.1285. In response to comments, we are finalizing the 
regulation text at Sec.  457.1206 with the following changes:
     In Sec.  457.1206(b)(1), we removed the exclusion for 
audited financial reports.
     We corrected the cross reference in Sec.  457.1206(b)(7) 
to Sec.  457.1233(a), (b), and (d);
    We also made the following technical corrections:
     In Sec.  457.1206(b)(1), we corrected the cross reference 
to Sec.  457.1201 and clarified that the standards related to physician 
incentive plans is located in Sec.  457.1201(h) and the standards 
related to mental health parity are in Sec.  457.1201(l);
     In Sec.  457.1206(b)(2), we removed the proposed cross 
reference to the rate development standards in Sec.  457.1203 because a 
similar cross reference to the Medicaid rate development standards in 
Sec.  438.5 was not included Sec.  438.9. Our intent was to align Sec.  
457.1206 with Sec.  438.9;
     We redesignated the paragraphs following paragraph (b)(2) 
to account for the change in paragraph (b)(2);
     In Sec.  457.1206(b)(8) we corrected the cross reference 
to Sec.  438.610, as cross referenced by Sec.  457.1285; and
     In Sec.  457.1206(b)(9), we added text and a cross 
reference to Sec.  457.1209 (relating to requirements for contacts 
involving Indians, Indian Health Care Providers, and Indian managed 
care entities) to maintain alignment with Medicaid regulations, which 
have added a similar cross reference to Sec.  438.14 in Sec.  438.9 of 
the final rule.
    Comment: Commenters noted that CMS included a cross reference to a 
new provision against provider discrimination in Sec.  457.1206(b)(4), 
but that we neglected to include a provision cross referencing to Sec.  
438.12 (the Medicaid provision against provider discrimination) in the 
regulatory text but cross-referenced Sec.  457.1208, which is about 
provisions related to Indians, IHCPs and IMCEs. They believed that CMS 
intended to fully align these provisions, and they recommended that HHS 
add a new provision to subpart L of part 457 for provider 
discrimination generally, and apply that new provision for NEMT PAHPs 
at Sec.  457.1206(b)(4).
    Response: Commenters are correct that we intended to incorporate 
anti-discrimination provisions in Sec.  438.12 into part 457, subpart 
L, and that the cross reference in Sec.  457.1206(b) to Sec.  457.1208 
as relating to provider non-discrimination requirements was an error as 
proposed Sec.  457.1208 referenced managed care contracts involving 
Indians, Indian Health Care Providers, and Indian Managed Care 
Entities. We are finalizing a new Sec.  457.1208 to address the 
incorporated protections regarding provider non-discrimination and we 
have redesignated proposed Sec.  457.1208 (relating to requirements for 
managed care contracts involving Indians, Indian Health Care Providers, 
and Indian Managed Care Entities) as Sec.  457.1209, and included a 
cross reference to both Sec.  457.1208 and Sec.  457.1209 in Sec.  
457.1206(b) of the final rule as applicable to NEMT PAHPs.
    After consideration of the public comments, we are finalizing Sec.  
457.1206 substantially as proposed with revisions to paragraph (b) to 
improve the sentence flow, to correct cross-references, and to add new 
text to include cross references to apply to NEMT PAHPS both 
requirements for managed care contracts involving Indians, Indian 
Health Care Providers, and Indian Managed Care Entities. We are not 
finalizing the exclusion of the contract requirement for the NEMT PAHP 
to submit audited financial reports and the requirement that the rates 
for NEMT PAHP be developed pursuant to Sec.  457.1203.
7. Information Requirements (Sec.  457.1207)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the provision of information standards at section 
1932(a)(5) of the Act apply to CHIP managed care programs. As such, we 
proposed to align CHIP with Medicaid information standards at Sec.  
438.10, which effectuate section 1932(a)(5) of the Act. We proposed 
adding Sec.  457.1207, which provides that states must require CHIP 
MCOs, PAHPs, PIHPs, PCCMs, and PCCM entities to provide enrollment 
notices, informational materials and instructional materials relating 
to enrollees and potential enrollees in the

[[Page 27761]]

same manner and subject to the same standards as provided in Sec.  
438.10. Including the cross reference to Medicaid managed care 
information standards supports CMS' goal to align and maximize 
coordination between insurance affordability programs. The proposed 
revisions include a more structured and coherent set of state and 
managed care plan standards for beneficiary information, and permit the 
availability of beneficiary information in electronic form.
    We received the following comments in response to our proposal to 
add Sec.  457.1207.
    Comment: Commenters supported adopting the Medicaid information 
requirements in CHIP. They did not have specific comments on the CHIP 
proposed regulation; they referred us to their comments on the Medicaid 
proposal.
    Response: We appreciate the support of this proposal. Because Sec.  
457.1207 cross-references the Medicaid regulation, it by reference 
incorporates all of the comments received on the Medicaid provision.
    After consideration of the public comments, we are finalizing Sec.  
457.1207 as proposed with minor wordsmithing revisions.
8. Requirement Related to Indians, Indian Health Care Providers, and 
Indian Managed Care Entities (Sec.  457.1209)
    Section 2107(e)(1)(M) of the Act, as added by section 5006 of ARRA, 
specifies that the provisions related to managed care contracts that 
involve Indians, Indian health care providers (IHCP), and Indian 
managed care entities (IMCE) at sections 1932(a)(2)(C) and 1932(h) of 
the Act apply to CHIP. As such, we proposed to align CHIP with Medicaid 
when MCOs, PIHPs, PAHPs, PCCMs, or PCCM entities enroll Indians and to 
incorporate the requirements at Sec.  438.14, which effectuate sections 
1932(a)(2)(C) and 1932(h) of the Act into the CHIP regulations at Sec.  
457.1208.
    We received the following comments on proposed Sec.  457.1208, 
redesignated at Sec.  457.1209 in the final rule.
    Comment: Commenters supported adopting the Medicaid information 
requirements in CHIP. They did not have specific comments on the CHIP 
proposed regulation; they referred us to their comments on the Medicaid 
proposal.
    Response: We appreciate the support of this proposal and refer 
readers to the responses to comments received on proposed Sec.  438.14.
    After consideration of the public comments, we are finalizing Sec.  
457.1208 as proposed but redesignated at Sec.  457.1209 with minor 
wordsmithing revisions.
9. Managed Care Enrollment (Sec.  457.1210)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the section 1932(a)(4) of the Act (relating to 
enrollment and disenrollment protections) applies to CHIP managed care 
programs. We proposed adding Sec.  457.1210 to implement section 
1932(a)(4)(C) and (D) of the Act (related to enrollment protections) 
for CHIP. We proposed adding Sec.  457.1212 to implement section 
1932(a)(4)(A) and (B) (related to disenrollment protections) for CHIP. 
Further discussion of Sec.  457.1212 is below.
    We did not propose to adopt in CHIP the full Medicaid enrollment 
provision for mandatory managed care enrollment in Sec.  438.54, which 
as proposed, required states to give potential enrollees a set period 
to choose a plan and required them to use a default enrollment process 
when individuals did not actively choose a plan. We did not propose the 
application of the choice or default enrollment provisions to CHIP 
because there is no requirement under Title XXI that states offer more 
than one managed care plan in CHIP. In addition, Title XXI provides 
states with flexibility in establishing the enrollment start date for 
CHIP, such that some states do not consider a child enrolled in CHIP 
until the family has actively selected a managed care plan and paid the 
applicable premium.
    Instead of adopting Sec.  438.54, we proposed standards in Sec.  
457.1210 for states that elect to use a default enrollment process. The 
standards were similar, but not identical, to those proposed for the 
default enrollment process established for Medicaid in Sec.  438.54(d).
    We received the following comments in response to our proposal to 
add Sec.  457.1210.
    Comment: Most commenters supported our approach. Many stated that 
adopting the Medicaid approach would delay coverage for CHIP 
beneficiaries by requiring a choice period, particularly in states that 
use prospective enrollment. However, one commenter suggested adopting 
the portion of the Medicaid provision that requires a choice period.
    Response: We appreciate the comments we received on this proposed 
provision. As noted above, we have decided to remove the choice period 
for Medicaid from the final regulation, and we are not adopting a 
choice period in CHIP. We agree with commenters that, in states that 
use prospective enrollment in CHIP, a choice period could result in a 
delay of coverage.
    Comment: One commenter encouraged us to adopt a default enrollment 
process in CHIP, which does not require a choice of more than one plan. 
Another commenter thought we proposed to require a default enrollment 
process, which the commenter opposed. Many others agreed with our 
proposed approach, indicating that the statute was ambiguous about 
whether a default enrollment process is required, and noting that such 
a process would be difficult to implement in CHIP.
    Response: We appreciate the comments on this topic. As we noted in 
the proposed regulation, we do not believe requiring a default 
enrollment process is appropriate for CHIP. Under this final rule, 
states would be permitted to use a default enrollment process, but are 
not required to do so. Some states use prospective enrollment, so 
children are not enrolled in the program until they have selected a 
managed care plan and, if applicable, paid a premium. Requiring a 
default enrollment process would disrupt this practice, which is 
permitted under the statute for CHIP.
    Comment: One commenter encouraged us to adopt the Medicaid 
provisions at Sec. Sec.  438.54(c)(3) and 438.54(d)(3), which requires 
that states provide informational notices to potential enrollees that 
explain the process for enrolling in an MCO, PIHP, PAHP, PCCM, or PCCM 
entity.
    Response: We appreciate these suggestions. We agree that states 
should provide thorough informational notices to potential enrollees, 
because in some cases, this notice will be the last one from the state 
to the enrollee until their eligibility redetermination or their annual 
right to change plans. It is critical that this notice be as complete, 
clear, factual, and easy to understand as possible. Plain language 
notices that are accessible to individuals with limited English 
proficiency and individuals living with disabilities is also critical, 
consistent with our standards for eligibility notices in Sec.  457.340. 
Therefore, we are adding a new paragraph (c) in Sec.  457.1210 of the 
final rule to include standards similar to those in Sec.  438.54(c)(3) 
and (d)(3).
    Comment: Several commenters suggested that we collect additional 
information about CHIP enrollment processes, to understand more fully 
the range of enrollment processes in the states.

[[Page 27762]]

    Response: We agree that it would be helpful to have additional 
information about CHIP enrollment processes and will consider the best 
way to collect such information and share best practices with states.
    Comment: One commenter asked us to make the list of additional 
criteria that states may consider to conduct default enrollment 
process, a requirement that states must take into consideration when 
conducting default enrollment processes in CHIP.
    Response: We included these optional criteria because we agree they 
could add value to a default enrollment processes and encourage states 
to utilize them as appropriate. However, inasmuch as states are not 
required to implement a default enrollment process, we believe that 
states should have the flexibility to determine when the criteria are 
both appropriate for their population and feasible for the state.
    Comment: One commenter noted a technical error in the proposed 
regulation. In proposed Sec.  457.1210(a)(1), the commenter noted that 
the text read ``To be a qualified, the MCO . . .'' when it should have 
read ``To be qualified, the MCO . . .''
    Response: We have made this correction.
    After consideration of the public comments, we are finalizing Sec.  
457.1210 with revisions. We are revising paragraph (a)(1) of this 
section to make a technical correction, revising the heading of the 
section, and adding paragraph (c) to clarify the information states 
should provide to beneficiaries about the enrollment process. We are 
not finalizing the proposal that states must ``seek to preserve 
existing provider-beneficiary relationships and relationships with 
providers that have traditionally served CHIP beneficiaries'' because a 
default enrollment process is not a requirement in CHIP, and instead 
provide states with flexibilities to use a variety of mechanisms, 
including previous encounter data and contacting enrollees, as a means 
to maintain provider-enrollee relationships. Additionally, as we are 
not requiring a default enrollment process in CHIP, we are finalizing 
an exception to the requirement that the state must evenly distribute 
beneficiaries equitably among contracted managed care plans. Also, we 
are simplifying the language at Sec.  457.1210(a)(3) which is finalized 
at Sec.  457.1210(a)(1)(iii).
10. Disenrollment (Sec.  457.1212)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the enrollment provision at section 1932(a)(4) of the 
Act applies to CHIP managed care programs. We proposed adding Sec.  
457.1212, which implements section 1932(a)(4)(A) and (B) of the Act for 
CHIP. The proposed regulation provided that states must follow, and 
ensure MCOs, PAHPs, PIHPs, PCCMs, and PCCM entities follow, the 
Medicaid disenrollment standards provided at Sec.  438.56. Section 403 
of CHIPRA did not apply the choice of managed care entity (MCE) 
standard in section 1932(a)(3) of the Act; therefore, separate CHIPs do 
not need to offer an alternative plan or delivery system option at the 
time of enrollment. However, because section 1932(a)(4) of the Act 
gives individuals the right to disenroll from their MCE while still 
remaining eligible to receive benefits, the state must contract with at 
least two MCEs, or contract with one MCE and operate an alternate 
delivery system, such as FFS, to provide CHIP benefits to those who 
have disenrolled from the state's contracted MCE. The state could also 
contract with some, or all, of the state's existing Medicaid provider 
network.
    We received the following comments in response to our proposal to 
add Sec.  457.1212.
    Comment: Commenters supported adopting the Medicaid disenrollment 
standards in CHIP.
    Response: We appreciate the support of this proposal.
    Comment: One commenter suggested that we adopt additional bases for 
disenrollment, including when an enrollee's provider leaves the 
network.
    Response: We believe our regulations at Sec.  457.1212 adequately 
provides the necessary minimum bases for disenrollment, as we are 
retaining alignment with Medicaid regulations at Sec.  438.56, which we 
believe includes the key provisions for permitting disenrollment. 
States have flexibility to permit disenrollment in other circumstances 
as they deem appropriate. We refer commenters to section I.B.5.b. of 
this final rule for additional discussion relating to Sec.  438.56.
    Comment: In proposed Sec.  457.1212, we noted that references to 
fair hearings in Sec.  457.56 should be read to refer to reviews as 
described in subpart K of part 457. One commenter encouraged us to have 
a single fair hearings process for both Medicaid and CHIP.
    Response: States have the flexibility to use the Medicaid fair 
hearings process for CHIP. However, since CHIP is not an entitlement 
program and does not confer the same due process protections as those 
that attach to Medicaid, we are not requiring states to use the 
Medicaid fair hearings process. If a state chooses to use a single 
process, it would need to comply with the Medicaid fair hearings 
regulations in part 431, subpart E and part 438, subpart F.
    After consideration of the public comments, we are finalizing Sec.  
457.1212 substantively as proposed but with minor wordsmithing 
revisions for clarity.
11. Conflict of Interest Safeguards (Sec.  457.1214)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the conflict of interest provisions at section 
1932(d)(3) of the Act apply to CHIP managed care programs. We proposed 
adding Sec.  457.1214, which provides that states have safeguards 
against conflict of interest in accordance with the terms of Sec.  
438.58.
    We received the following comments in response to our proposal to 
add Sec.  457.1214.
    Comment: Commenters supported adopting the Medicaid conflict of 
interest safeguards in CHIP. They did not have specific comments on the 
CHIP proposed regulation; they referred us to their comments on the 
Medicaid proposal.
    Response: We appreciate the support of this proposal and refer 
readers to the responses to comments received on proposed Sec.  438.58.
    After consideration of the public comments, we are finalizing Sec.  
457.1214 substantively as proposed but with minor revisions for 
clarity.
12. Continued Services to Enrollees (Sec.  457.1216)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the enrollment provision at section 1932(a)(4) of the 
Act applies to CHIP managed care programs. This provision is described 
above in the discussion of the Medicaid provision at Sec.  438.62. 
Related to change in enrollment, we proposed adding Sec.  457.1216, 
which provides that states must follow the Medicaid standards related 
to continued services to enrollees at Sec.  438.62.
    We received the following comments in response to our proposal to 
add Sec.  457.1216.
    Comment: Commenters did not have specific comments on the CHIP 
proposed regulation; they referred us to their comments on the Medicaid 
proposal.
    Response: We refer readers to the responses to comments received on 
proposed Sec.  438.62.

[[Page 27763]]

    After consideration of the public comments, we are finalizing Sec.  
457.1216 substantively as proposed with minor revisions for clarity.
13. Network Adequacy Standards (Sec.  457.1218)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the provisions at section 1932(a)(5) of the Act, 
requiring that MCEs assure adequate capacity to serve expected 
enrollment, apply to CHIP managed care programs. As such, we proposed 
to align CHIP with Medicaid network adequacy standards at Sec.  438.68, 
which effectuate section 1932(a)(5) of the Act. We proposed adding 
Sec.  457.1218, which provides that states have network adequacy 
standards and ensure that MCOs, PIHPs, and PAHPs meet such standards in 
accordance with the terms of Sec.  438.68. We solicited comment on 
whether we should include additional standards for additional types of 
pediatric providers, for example children's hospitals or child and 
adolescent behavioral health providers.
    We received the following comments in response to our proposal to 
add Sec.  457.1218.
    Comment: Several commenters supported the addition of network 
adequacy standards for CHIP at Sec.  457.1218 and their alignment with 
Medicaid at Sec.  438.68. Specifically, commenters applauded the 
additional pediatric-focused network adequacy requirements that CMS 
included for Medicaid and CHIP, such as pediatric primary care, 
specialty care, and dental standards.
    One commenter suggested that CMS amend Sec.  457.1218 by deleting 
the second sentence for additional requirements for pediatric 
specialists and dentists, as that requirement is already captured in 
Sec.  438.68. Other commenters asked us to further clarify the second 
sentence to say that CHIP covers comprehensive services.
    Many commenters responded to CMS' request for comments regarding 
whether states should require network adequacy standards for additional 
types of pediatric providers. Commenters recommended that CMS include 
standards for mental health and substance use providers, optometrists, 
developmental specialists, pediatric hospitals, as well as other 
pediatric subspecialists. One commenter recommended that networks 
should include providers that are capable of providing treatment in 
particular settings. Another commenter suggested that CMS apply 
standards based on adequate access to specialists rather than provider 
type. In contrast, some commenters stated that it was not necessary for 
CMS to include network adequacy standards for additional types of 
pediatric providers in CHIP.
    Response: We are removing the second sentence in proposed Sec.  
457.1218, because we agree with commenters that it is redundant with 
the Medicaid standards in Sec.  438.68(b) and could create confusion 
about the types of services states must provide in CHIP. After further 
consideration of the proposed policy and comments, we decline to list 
additional provider types and categories as commenters recommended. We 
are not requiring states to add children's hospitals as a network 
provider, as there is not a parallel requirement in Medicaid and the 
limited availability of children's hospitals may affect plan 
participation. We encourage states and plans to include children's 
hospitals in their provider networks whenever possible. Furthermore, we 
believe that the provider types listed in Sec.  438.68 (which includes 
certain pediatric providers) strikes the appropriate balance of 
ensuring access to care and state flexibility. However, note that we 
have added pediatric behavioral health specialists at Sec.  438.68(b) 
of the final rule as one of the provider types for which states must 
develop standards for Medicaid managed care plans, which also applies 
to CHIP managed care plans by cross-reference. In addition, states have 
the authority to add additional provider types to their network 
adequacy standards to meet the needs of their CHIP programs and 
enrollees.
    Comment: One commenter requested clarification of what flexibility 
will be provided to states with workforce shortages in pediatric 
specialties.
    Response: Under Sec.  438.68 of the regulation, applied to CHIP by 
cross reference at Sec.  457.1218, states have the flexibility to 
define network adequacy standards. The standards can reflect known 
workforce shortages, if determined appropriate by the state. We believe 
that states will be in the best position to determine the 
appropriateness of incorporating workforce shortages into their network 
adequacy standards.
    Comment: Many commenters referred us to their comments on the 
proposed regulation at Sec.  438.68 or made comments similar to those 
that were made on that regulation.
    Response: We refer commenters to the preamble discussion of Sec.  
438.68 above for a more complete discussion of the comments we received 
on these provisions.
    After consideration of the public comments, we are deleting the 
second sentence of proposed Sec.  457.1218, making minor revisions to 
improve the clarity of the text, but otherwise finalizing as proposed.
14. Enrollee Rights (Sec.  457.1220)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the enrollee rights provisions at section 
1932(a)(5)(B)(ii) of the Act apply to CHIP managed care programs. As 
such, we proposed to align CHIP with Medicaid enrollee rights 
provisions at Sec.  438.100, which effectuate section 1932(a)(5)(B)(ii) 
of the Act. We proposed adding Sec.  457.1220, which provides that 
states must ensure that MCOs, PAHPs, PIHPs, PCCMs, and PCCM entities 
follow the enrollee rights standards in accordance with the terms of 
Sec.  438.100.
    We received the following comments in response to our proposal to 
add Sec.  457.1220.
    Comment: We received only one comment on this provision, which 
supported adopting Sec.  438.100 in CHIP.
    Response: We thank the commenter for their support.
    After consideration of the public comments, we are finalizing Sec.  
457.1220 substantively as proposed, with minor revisions for clarity.
15. Provider-Enrollee Communication (Sec.  457.1222)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the enrollee rights provisions at section 1932(b)(3) of 
the Act apply to CHIP managed care programs. As such, we proposed to 
align CHIP with Medicaid's enrollee rights protections of 
communications between providers and enrollees at Sec.  438.102, which 
effectuate section 1932(b)(3) of the Act. We proposed adding Sec.  
457.1222, which provides that states must ensure that MCOs, PAHPs, and 
PIHPs protect communications between providers and enrollees in 
accordance with the terms of Sec.  438.102.
    We received the following comments in response to our proposal to 
add Sec.  457.1222.
    Comment: We received only one comment on this provision, which 
supported adopting Sec.  438.102 in CHIP.
    Response: We thank the commenter for their support.
    After consideration of the public comments, we are finalizing Sec.  
457.1222 substantively as proposed, with minor revisions for clarity.
16. Marketing Activities (Sec.  457.1224)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the restrictions on

[[Page 27764]]

marketing at section 1932(d)(2) of the Act apply to CHIP managed care 
programs. As such, we proposed to align CHIP with Medicaid standards 
related to marketing at Sec.  438.104, which effectuate section 
1932(d)(2) of the Act. We proposed adding Sec.  457.1224, which 
provides that states must ensure that MCOs, PAHPs, PIHPs, PCCMs, and 
PCCM entities follow the standards of Sec.  438.104. The proposed 
definition of marketing in Sec.  438.104(a), as adopted by cross-
reference in Sec.  457.1224, excludes the communication to a CHIP 
beneficiary from the issuer of a QHP. Therefore, a QHP issuer that also 
operates a CHIP managed care plan would not be prohibited from 
contacting a family with CHIP eligible children about QHP coverage. 
Indeed, we recognize that there may be benefit to the family from being 
informed about the availability of coverage through the Marketplace and 
selecting an issuer who offers both types of products.
    We solicited comment on whether our proposed approach was 
appropriate, or whether we should take an alternate approach, for 
example by following the QHP marketing regulations at 45 CFR 156.225 or 
adopting a subset of the Medicaid regulations. We also specifically 
solicited comment on our proposal to apply to CHIP the standard at 
Sec.  438.104(c) that, in reviewing marketing materials, the state must 
consult with the Medical Care Advisory Committee or an advisory 
committee with similar membership.
    We received the following comments in response to our proposal to 
add Sec.  457.1224.
    Comment: Most commenters expressed support for adopting the 
Medicaid marketing standards in CHIP, although several asked for 
clarifications or modifications. Several commenters opposed the 
provision in Sec.  457.1224 that would permit QHP issuers to market QHP 
plans to families of CHIP-eligible children, and recommend that CMS 
change this standard. Similarly, some commenters expressed concern that 
exclusion of QHPs from the definition of private insurance would allow 
QHPs with Medicaid and CHIP enrollment information to target current 
enrollees without abiding by the marketing safeguards. In contrast, 
some commenters supported the proposed marketing rules allowing 
Medicaid and CHIP MCOs to provide QHP information to beneficiaries.
    Response: We specifically excluded communications by QHPs from the 
definition of marketing because of the high rate of CHIP and Medicaid 
beneficiaries that move between those programs and the Marketplace, and 
the number of parents of CHIP children who are QHP eligible. We believe 
the exclusion of QHPs from the definition of marketing will facilitate 
coverage and provide enrollees with information that will enable them 
to make more informed managed care plan selections.
    Comment: One commenter requested that CMS specifically address and 
permit states to allow licensed agents and brokers to have an active 
role in marketing CHIP managed care products in Sec.  457.1224.
    Response: Section 438.104(a) provides that the terms ``MCO, PIHP, 
PAHP, PCCM or PCCM entity'' include any of the entity's employees, 
network providers, agents, or contractors. Licensed agents and brokers 
which are serving as an agent or contractor of a plan can engage in 
marketing activities on the plan's behalf, subject to the provisions of 
Sec.  438.104, incorporated into the CHIP regulations by cross 
reference at Sec.  457.1224.
    Comment: Several commenters opposed CMS's proposal to apply Sec.  
438.104(c) to CHIP and recommended that consultation with the Medical 
Care Advisory Committee be left to the discretion of the state.
    Response: We appreciate commenters' input on this topic. We agree 
that CHIP should have flexibility in this area, given that the Medical 
Care Advisory Committee was created under Title XIX as an advisory 
committee specific to Medicaid. CHIP does not require a similar 
advisory body. We are finalizing Sec.  457.1224 with text to exclude 
the requirement in Sec.  438.104(c) from Sec.  457.1224 in the final 
regulation, although we encourage states to consult with their Medical 
Care Advisory Committee in reviewing CHIP plans' marketing materials, 
as we believe that this Advisory Committee has expertise which would be 
valuable for CHIP, as well as Medicaid.
    Comment: Many commenters referred us to their comments on the 
proposed regulation at Sec.  438.104 or made comments similar to those 
that were made on that regulation.
    Response: We refer commenters to the preamble discussion of Sec.  
438.104 above for a more complete discussion of the comments we 
received on these provisions.
    After consideration of the public comments, we are finalizing Sec.  
457.1224 as proposed, except that we are excluding the standards in 
Sec.  438.104(c) for CHIP and making minor revisions for clarity.
17. Liability for Payment (Sec.  457.1226)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the protections for enrollees against liability for 
payment at section 1932(b)(6) of the Act apply to CHIP managed care 
programs. As such, we proposed to align CHIP with Medicaid liability 
protections at Sec.  438.106, which effectuate section 1932(b)(6) of 
the Act. We proposed adding Sec.  457.1226, which provides that states 
must ensure that MCOs, PAHPs, and PIHPs do not hold enrollees liable 
for services or debts of the MCO, PAHP, and PIHP in accordance with the 
terms of Sec.  438.106.
    We received the following comments in response to our proposal to 
add Sec.  457.1226.
    Comment: We received one comment on this provision, seeking to 
reconcile Sec.  457.1226 with proposed Sec.  438.420(d).
    Response: CHIP regulations do not incorporate Sec.  438.420, so 
there is no need to reconcile Sec.  457.1226 and Sec.  438.420(d).
    After consideration of the public comments, we are finalizing Sec.  
457.1226 substantively as proposed but with minor revisions for 
clarity.
18. Emergency and Poststabilization Services (Sec.  457.1228)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the requirement that MCEs provide emergency and 
poststabilization services at section 1932(b)(2) of the Act applies to 
CHIP managed care programs. As such, we proposed to align CHIP with the 
Medicaid emergency and poststabilization services standard at Sec.  
438.114, which effectuates section 1932(b)(2) of the Act. We proposed 
adding Sec.  457.1228, which provides that states must ensure that 
MCOs, PAHPs, and PIHPs make emergency and poststabilization services 
available, and that the state make emergency and poststabilization 
services available to enrollees of PCCMs and PCCM entities, in 
accordance with the terms of Sec.  438.114.
    Comment: We received only one comment on this provision, which 
supported adopting Sec.  438.114 in CHIP.
    Response: We thank the commenter for their support.
    After consideration of the public comments, we are finalizing Sec.  
457.1228 substantively as proposed, but with minor revisions for 
clarity.
19. Access Standards (Sec.  457.1230)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the quality assurance standards at section 1932(c) of 
the Act apply to CHIP managed care programs. Section 1932(c)(1) of the 
Act requires states that contract with MCOs to

[[Page 27765]]

develop and implement a quality assessment and improvement strategy 
that addresses standards related to access, which we interpret as 
including standards related to the availability of services, 
coordination and continuity of care, and coverage and authorization of 
services. As such, we proposed to align CHIP with Medicaid access 
standards at Sec. Sec.  438.206, 438.207, 438.208, and 438.210, which 
implement section 1932(c)(1) of the Act.
    We proposed adding Sec.  457.1230(a), which provides that states 
must require CHIP MCOs, PAHPs, and PIHPs to ensure that covered 
services are available and accessible to enrollees in accordance with 
the terms of Sec.  438.206. At Sec.  457.1230(b), we proposed that 
states must ensure that CHIP MCOs, PAHPs, and PIHPs have adequate 
capacity to serve expected enrollees in accordance with the terms of 
Sec.  438.207. At Sec.  457.1230(c), we proposed that states must 
ensure that CHIP MCOs, PAHPs, and PIHPs comply with the coordination 
and continuity of care standards in accordance with the terms of Sec.  
438.208.
    Finally, at Sec.  457.1230(d), we proposed that states must ensure 
that CHIP MCOs, PAHPs, and PIHPs comply with some of the coverage and 
authorization of services standards in accordance with the terms of 
Sec.  438.210. There are several paragraphs of Sec.  438.210 that we 
did not propose to apply to CHIP managed care, including the standards 
related to medically necessary services in Sec.  438.210(a)(5), because 
CHIP does not need to use the same medical necessity standard as 
Medicaid, and states are not required to provide EPSDT benefits in 
CHIP. In addition, we did not propose to adopt the time frames for 
decisions in Sec.  438.210(d). Instead, we proposed to follow the time 
frames described in Sec.  457.1160. We also solicited comment on 
whether we should create an exception for Sec.  438.210(b)(2)(iii) 
(related to authorizing LTSS based on an enrollee's current needs 
assessment and consistent with the person-centered service plan), since 
LTSS is not a required service and few separate CHIP programs provide 
this service. We made a technical error in Sec.  457.1230(d)(2) of the 
proposed regulation. We stated that CHIP should follow the notice of 
adverse benefit determination requirements of Sec.  457.1260, rather 
than those of Sec.  438.210(c). However, both Sec.  457.1260(c) and 
Sec.  438.210(c) require that notices of adverse benefit determinations 
to meet the standards of Sec.  438.404. Therefore, the exception we 
made in Sec.  457.1230(d)(2) is not necessary, and we have removed it.
    We received the following comments in response to our proposal to 
add Sec.  457.1230.
    Comment: Commenters supported adopting the Medicaid availability of 
services standards in Sec.  438.206 for CHIP. They did not have 
specific comments on the CHIP proposed regulation; they referred us to 
their comments on the Medicaid proposal.
    Response: We appreciate the support of this proposal and refer 
readers to the responses to comments received on proposed Sec.  
438.206.
    Comment: Commenters supported adopting the Medicaid assurances of 
adequate capacity and services at Sec.  438.207 in CHIP at Sec.  
457.1230(b). One commenter suggested that CMS add a stipulation to 
Sec.  457.1230(b) that entities should be able to document their 
ability to provide access to pediatric specialty providers.
    Response: Sections 438.68, 438.206, and 438.207 of the final rule, 
which are applied to CHIP via cross-reference per Sec. Sec.  457.1218, 
457.1230(a) and 457.1230(b) require states and MCOs, PIHPs, and PAHPs 
to demonstrate access to pediatric specialists. Section 438.68, applied 
to CHIP via cross reference at Sec.  457.1218, requires states to 
develop network adequacy standards for pediatric specialists, among 
other types of providers. Section 438.206(a), incorporated by cross-
reference at Sec.  457.1230(a) in CHIP, requires states to ensure that 
each MCO, PIHP, and PAHP has provider networks that meet the standards 
in Sec.  438.68. Section 438.207(d), incorporated by cross-reference at 
Sec.  457.1230(b) requires states ensure that each MCO, PIHP, and PAHP 
meets the state's standard for availability of services in Sec.  
438.206. We do not believe that additional regulation text requiring 
application of access standards to pediatric specialists is necessary.
    Comment: Several commenters supported the addition of Sec.  
457.1230(c) related to continuity and coordination of care standards. 
However, one commenter stated that the coordination of care standards 
at Sec.  438.208 should not apply to CHIP because care coordination is 
not a covered service in many CHIP plans.
    Response: We disagree that the standards in Sec.  438.208 should 
not apply to CHIP. While states are not required to cover care 
coordination as a specific benefit under CHIP, facilitating 
coordination and continuity of care are a fundamental component of a 
managed care delivery system. If states choose to provide CHIP services 
through managed care, the standards in Sec.  438.208 will apply.
    Comment: Several commenters expressed support for the omission of 
standards related to medically necessary services at Sec.  
438.210(a)(5). However, one commenter suggested that CMS add language 
to this subsection to give states discretion to use the standard in 
Sec.  438.210(a)(5) and another commenter recommended that CMS follow 
the EPSDT federal guidance for medical necessity as a minimum standard.
    Response: We are maintaining the exception to Sec.  438.210(a)(5) 
for CHIP. While medical necessity is essentially an individualized 
medical determination, we do not require states to use the same medical 
necessity standard for a separate child health program as the standard 
adopted either for Medicaid beneficiaries generally, or the medical 
necessity standard applied for the EPSDT benefit per section 1905(r)(5) 
of the Act. States have the flexibility to adopt the same standard for 
both programs, and states have the flexibility under the regulation to 
apply EPSDT standards to CHIP; specific regulatory authority is not 
needed.
    Comment: Several commenters suggested that we should not create an 
exemption from the timeliness standards in Sec.  438.210(d) for CHIP. 
They stated that this would create a significant inconsistency with 
Medicaid, as CHIP MCOs, PIHPs, and PAHPs would have 90 days to make 
coverage decisions, while Medicaid decisions must be made within 14 
days.
    Response: We agree with commenters that the timeframes for coverage 
decisions made by Medicaid and CHIP managed care plans should align. We 
now believe our deference to the timeframes in Sec.  457.1160 for CHIP 
in the proposed rule was misplaced. Section 457.1160 relates to reviews 
of eligibility and health services matters conducted by the State 
agency. Section 438.210(d), in contrast, relates to coverage 
authorization decisions made by managed care plans. We are removing the 
exception to Sec.  438.210(d) from Sec.  457.1230(d). Under the final 
rule, MCOs, PIHPs and PAHPs in CHIP will be held to the same timeframes 
for making coverage decision as are applied to MCOs, PIHPs and PAHPs in 
Medicaid.
    Comment: CMS sought comment regarding whether CHIP should be 
exempted from the standard in Sec.  438.210(b)(2)(iii) relating to 
authorizing LTSS. Several commenters recommended that CMS adopt the 
standard for CHIP to benefit children with chronic conditions and other 
special health care needs. Other commenters supported creating an

[[Page 27766]]

exception because states are not required to cover any LTSS under CHIP.
    Response: We agree with the commenters who stated that CHIP Sec.  
438.210(b)(2)(iii) should not be applied to CHIP, as states are not 
required to cover LTSS under CHIP, and many states do not do so. States 
that choose to cover LTSS will have flexibility to determine the role 
the MCOs and other entities have in authorizing LTSS.
    After consideration of the public comments, we are finalizing Sec.  
457.1230 substantially as proposed, except that we are removing Sec.  
457.1230(d)(2) and (d)(3) from the exceptions and adding paragraph 
(b)(2)(iii) to the exceptions, for reasons described in the responses 
to comments. We are also finalizing minor revisions to the text to 
improve its clarity.
20. Structure and Operation Standards (Sec.  457.1233)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that section 1932(c)(1) of the Act, relating to developing 
and implementing a quality and assessment improvement strategy, 
including access standards, examination of care and service delivery, 
and monitoring procedures applies to CHIP. Sections 438.214 (related to 
provider selection), 438.230 (related to subcontractual relationships 
and delegation), 438.236 (related to practice guidelines), and 438.242 
(related to health information systems) effectuate section 1932(c)(1) 
of the Act. We proposed adding Sec.  457.1233 to align CHIP with 
Medicaid standards in Sec. Sec.  438.214, 438.230, 438.236, and 
438.242. Section Sec.  438.224 (relating to confidentiality) also 
implements section 1931(c)(1) of the Act. However, we did not propose 
that CHIP align with the Medicaid confidentiality provision as set 
forth in Sec.  438.224 because there is an existing confidentiality 
requirement at Sec.  457.1110, which is similar to the standard in 
Sec.  438.224.
    Comment: Several commenters expressed support for the alignment of 
CHIP with Medicaid structure and operation standards as proposed.
    Response: We thank commenters for their support.
    Comment: One commenter suggested that CMS make several revisions to 
Sec.  438.230 related to subcontractual relationships and delegation 
that should also directly to CHIP at Sec.  457.1233.
    Response: We address this comment in section I.B.4.b. of this final 
rule, relating to Sec.  438.230.
    Comment: Several commenters supported the reliance on existing CHIP 
standards at Sec.  457.1110 related to confidentiality requirements. 
However, some commenters stated that they did not identify a provision 
in subpart L of part 457 which would apply this confidentiality 
provision to managed care.
    Response: We agree with commenters that subpart L should include a 
cross reference to Sec.  457.1110. We have added a cross reference in 
Sec.  457.1233(e) related to confidentiality requirements.
    After consideration of the public comments, we are adding a cross 
reference to Sec.  457.1110 in a new paragraph (e), and otherwise 
finalizing Sec.  457.1233 as proposed.
21. Quality Measurement and Improvement (Sec.  457.1240, Sec.  457.700, 
Sec.  457.760)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that section 1932(c) of the Act applies to CHIP managed care 
programs. As such, we proposed (with minor exceptions) to align CHIP 
with Medicaid quality measurement and improvement standards at 
Sec. Sec.  438.330, 438.332, 438.334, and 438.340, which implement 
section 1932(c) of the Act. We proposed adding Sec.  457.1240(a), which 
describes the scope of the quality measurement and improvement 
standards. At Sec.  457.1240(b), we proposed that states must ensure 
that CHIP MCOs, PIHPs and PAHPs have an ongoing comprehensive QAPI 
program for the services they furnish to enrollees as set forth in 
Sec.  438.330. At Sec.  457.1240(c), we proposed that states must 
review and approve the performance of each MCO, PIHP, and PAHP in 
accordance with the requirements set forth in Sec.  438.332. At Sec.  
457.1240(d), we proposed that states must collect data and apply the 
methodology established under the process described in Sec.  
438.330(a)(2) to determine a Managed Care rating or ratings for each 
CHIP MCO, PIHP, and PAHP in accordance with the standards set forth in 
Sec.  438.334. At Sec.  457.1240(e), we proposed to adopt the elements 
of the state comprehensive quality strategy related to managed care set 
forth in Sec.  438.340. Finally, at Sec.  457.760, we proposed that 
states must incorporate CHIP into their state comprehensive quality 
strategy that establishes the minimum standards inclusive of all 
delivery systems as set forth in Sec.  431 subpart I.
    We received the following comments in response to our proposal to 
add Sec.  457.760 and Sec.  457.1240.
    Comment: Several commenters supported including CHIP in the state 
comprehensive quality strategy. Commenters made suggestions for 
additions or clarifications to the comprehensive quality strategy to 
reflect the CHIP population and children in general.
    Response: We appreciate the support for this provision and 
suggestions to improve it. However, because we are not finalizing the 
comprehensive quality strategy in subpart I of part 431 (see discussion 
in section I.B.6.c of this rule), we are not finalizing the CHIP 
component of the comprehensive quality strategy in Sec.  457.760 or the 
related changes to the basis, scope, and applicability provision in 
Sec.  457.700. The parts of proposed subpart I of part 431 
(specifically, of proposed Sec.  431.502) which are included in Sec.  
438.340 of the final regulation are also included in the final rule for 
CHIP via the cross reference to Sec.  438.340 in Sec.  457.1240(e).
    Comment: Commenters noted that we indicated in the preamble that we 
were adopting Sec.  438.310 in CHIP, but it was not cross-referenced in 
the regulatory text. They encouraged us to add the cross-reference in 
Sec.  457.1240.
    Response: We decline to cross-reference to Sec.  438.310 in Sec.  
457.1240 because we believe that Sec. Sec.  438.310(a) and 438.310(b) 
simply describe the statutory basis and scope of the quality 
measurement and improvement regulations in detail.
    Comment: One commenter suggested that we should not adopt Sec.  
438.340 in CHIP, or limit the number of PIPs to the number that would 
produce the most value.
    Response: We are maintaining this provision in the final rule. We 
believe a robust QAPI program supports managed care plans' efforts to 
assess and improve the quality of care provided to enrollees, and that 
the annual review of a plan's QAPI can assist the state in plan 
oversight and is important component for CHIPs. The performance 
measures and PIPs conducted under QAPI provide valuable information 
which is validated and independently evaluated during the annual EQR 
process. This section is critical for states' ability to assess the 
quality of care provided by MCOs, PIHPs, and PAHPs, and CMS's ability 
to oversee states and managed care entities through EQR reports. States 
are in the best position to determine the number of PIPs appropriate 
for their managed care plans. Therefore, under Sec. Sec.  438.330 and 
457.1240(b) of the final rule, states have flexibility to identify the 
appropriate number of PIPs, as long as the PIPs identified include any 
which may be specified by CMS under Sec.  438.330(a)(2).
    Comment: Several commenters expressed concern that states would be 
required to create separate quality

[[Page 27767]]

strategies for Medicaid and CHIP. The commenters suggested that 
separate quality strategies would be duplicative and burdensome to 
states, providers, MCOs, and EQROs.
    Response: States may create a single, combined quality strategy for 
Medicaid and CHIP. Because CHIP has adopted most, but not all, of the 
Medicaid regulations, states using a combined quality strategy would 
need to comply with all of the Medicaid regulations. If a state opts to 
create combined quality strategies for Medicaid and CHIP, it will be 
critical that it choose measures and PIPs that focus on pediatric care.
    Comment: One commenter noted that in states where the CHIP benefits 
differ from Medicaid, the resources required to separately measure and 
report data on CHIP may be substantial. The commenter recommended that 
CMS encourage states to account for the additional administrative 
resources that will be needed to accomplish the regulatory standards in 
capitation payments.
    Response: We agree with the commenter that states should accurately 
account for the cost of conducting quality activities in the capitation 
payment to MCOs, PIHPs, and PAHPs.
    Comment: Several commenters referred us to their comments on the 
Medicaid quality measurement and improvement proposals in Sec. Sec.  
438.310 through 438.340.
    Response: We refer readers to the responses to comments received on 
proposed Sec. Sec.  438.310 through 438.340.
    After consideration of the public comments, we are not finalizing 
the changes to Sec.  457.700, and are not adding Sec.  457.760. We are 
finalizing Sec.  457.1240, with the following revisions:
     We are clarifying that the standards set forth in 
paragraphs (b) and (e) apply to risk-bearing PCCM entities by adding a 
reference to PCCM entities to paragraph (a) and are adding paragraph 
(f) to describe the subset of PCCM entities to which paragraphs (b) and 
(e) apply. In the proposed regulation, these requirements were 
described in Sec.  457.1201(m), which specified the quality measurement 
and improvement standards that applied to PCCM entities, but they were 
not included in Sec.  457.1240. In addition, we are revising paragraphs 
(b) and (e) to specify which paragraphs of Sec.  438.330 and Sec.  
438.340 apply to PCCM entities. We are also correcting the cross-
reference to Sec.  438.330(d)(4), related to standards for plans that 
serve dual eligibles.
     We are removing the reference to Sec.  438.330(a)(2) from 
paragraph (d), to align with changes to Sec.  438.330.
     We are revising paragraph (c) to align with the changes 
made to Sec.  438.332.
    As discussed in section I.B.6.c of the preamble for Sec.  438.334 
above, we are not finalizing the proposed option for states to default 
to the MA Five-Star Rating system for those plans that serve dual 
eligible beneficiaries only, therefore all of the managed care quality 
rating system requirements in Sec.  438.334 are incorporated here to 
apply to CHIP. The regulation text has been updated to reflect this 
change.
     Updating paragraph (e) to reflect the changes to the 
quality strategy.
     Finally, we are finalizing a new paragraph (f) to explain 
how and when these standards apply to PCCM entities in CHIP.
22. External Quality Review (Sec.  457.1250)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the EQR standards at section 1932(c) of the Act apply to 
CHIP managed care programs. Section 1932(c)(2) of the Act requires 
external independent review of managed care activities. As such, we 
proposed to align CHIP with Medicaid EQR standards at Sec.  438.350, 
which effectuate section 1932(c)(2) of the Act. At Sec.  457.1250(a), 
we proposed that each state that contracts with MCOs, PIHPs or PAHPs 
follow all applicable EQR standards as set forth in Sec. Sec.  438.350, 
438.352, 438.354, 438.356, 438.358, and 438.364. We did not propose to 
adopt provisions related to plans serving dual eligible populations, 
because CHIP has a very limited number of dual eligibles. We note that 
the cost of CHIP quality activities (including EQR) represents an 
administrative expense, subject to the 10 percent limit on 
administrative expenditures permitted for non-primary services as set 
forth in section 2105(a) and (c) of the Act.
    Proposed Sec.  457.1250(b), outlined the provisions that do not 
apply to the CHIP EQR process for states contracting with MCOs, PIHPs 
or PAHPs, including the nonduplication of mandatory activities at Sec.  
438.360 and the exemption from EQR at Sec.  438.362. We also proposed 
allowing states to amend current EQR contracts for Medicaid to add 
CHIP.
    We received the following comments in response to our proposal to 
add Sec.  457.1250.
    Comment: Several commenters suggested that quality activities 
should not be subject to the 10 percent administrative limit. They 
suggested that treating quality activities as a primary expenditure 
under Sec.  457.618 (which would result in their exemption from the 
administrative limit) was consistent with the treatment of quality-
related activities under the MLR. In the MLR, quality-related 
activities are part of the numerator, suggesting that they are more 
closely linked to claims than to administrative expenses. One commenter 
requested that if CMS applied the 10 percent limit to quality 
activities, we allow ``look alike'' CHIP programs to prorate EQRO 
activities based on the Medicaid/CHIP population ratio in the state.
    Response: Section 2105(a) and (c) limit CHIP expenditures that are 
not for health benefits to 10 percent of the state's total computable 
expenditures on health benefits (referred to as the 10 percent 
administrative limit). Quality activities do not fall into the 
definition health benefits, and therefore are subject to this limit. In 
terms of prorating EQRO activities based on the ratio of Medicaid and 
CHIP populations in the state, allocation of joint costs appears to be 
required by cost allocation principles. Thus, we are open to discussing 
the suggested allocation method, or other reasonable allocation methods 
with states.
    Comment: One commenter requested that CMS allow for the non-
duplication of mandatory activities in Sec.  438.360 when CHIP plans 
also participate in Medicaid and are accredited already by a national 
accrediting organization.
    Response: We agree with the commenter that states should be 
permitted to use information from private accreditation reviews that 
support Medicaid EQR activities if the conditions for non-duplication 
set forth in Sec.  438.360 are met, and we are incorporating this 
option for CHIP by cross reference at Sec.  457.1250(a). For states to 
exercise this option under Sec.  438.360, the state is required to 
identify in its quality strategy the EQR activities for which it has 
exercised the option, and explain the rationale for the State's 
determination that the private accreditation activity is comparable to 
the EQR activities identified. We are not permitting Medicare 
accreditation to substitute for EQR activities for CHIP, however, as 
very few children are covered under Medicare and therefore the findings 
from a Medicare accreditation would not be relevant for children.
    Comment: Several commenters referred us to their comments on the 
Medicaid EQR proposals in Sec. Sec.  438.350, 438.352, 438.354, 
438.356, 438.358, and 438.364.
    Response: We refer readers to the responses to comments received on 
proposed Sec. Sec.  438.350, 438.352, 438.354, 438.356, 438.358, and 
438.364.

[[Page 27768]]

    After consideration of the public comments, we are finalizing Sec.  
457.1250 with the following revisions
     We are incorporating the option for states to use 
information from private accreditation reviews in paragraph (a) and 
adding text to address PCCM entities;
     We are deleting paragraph (b)(1), because we believe it is 
unnecessary to state which provisions of part 438, subpart E do not 
apply to CHIP. If they are not listed in paragraph (a), they do not 
apply.
     We are redesignating paragraph (b)(2) as paragraph (b) and 
deleting the clause ``provided that the existing contract meets the 
requirements in Sec.  438.356.'' This language is unnecessary because 
all Medicaid contracts must meet the requirements of Sec.  438.356, 
which is not being changed through this rulemaking.
23. Grievances (Sec.  457.1260)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies section 1932(b)(4) of the Act, relating to grievances, 
applies to CHIP managed care programs. As such, we proposed generally 
to align CHIP with the Medicaid grievance and appeals sections in 
subpart F of part 438, which implement section 1932(b)(4) of the Act. 
We proposed adding Sec.  457.1260, which provides that states must 
ensure that MCOs, PAHPs, and PIHPs comply with subpart F of part 438, 
with one exception. Specifically, we did not propose to adopt Sec.  
438.420, which requires continuation of benefits pending appeal. 
Proposed Sec.  457.1260 also provides that references to fair hearings 
in subpart F of part 438 should be read as references to reviews as 
described in subpart K of part 457.
    We received the following comments in response to our proposal to 
add Sec.  457.1260.
    Comment: Nearly all commenters were supportive of applying the 
Medicaid appeal and grievance provisions to CHIP. Many commenters 
suggested that CMS also apply to CHIP the standards in Sec.  438.420, 
which require MCOs, PIHPs, and PAHP to continue benefits until the 
resolution of an appeal or state fair hearing. Commenters noted that 
excluding Sec.  438.420 from CHIP would allow managed care entities to 
deny provision of medical services to CHIP enrollees pending an appeal. 
In addition, one commenter stated that a pre-termination hearing is a 
basic due process right for a government benefit program. In contrast, 
some commenters recognized that while benefits pending appeal would be 
valuable to CHIP enrollees, the nature of the CHIP program merits 
different treatment.
    Response: We agree with the commenters who believe that the 
standards in Sec.  438.420 should not be applied to CHIP. The right to 
benefits pending the outcome of a grievance or appeal does not derive 
from section 1932(b)(4), but from the constitutional due process 
protections afforded to beneficiaries of an entitlement program, under 
Goldberg v. Kelly, 397 U.S. 254 (1970) and its progeny, including 
provision of benefits to beneficiaries who are being terminated from or 
denied coverage pending appeal. Unlike Medicaid, CHIP is not an 
entitlement program. Therefore, we do not believe that it appropriate 
to apply this requirement to CHIP.
    Comment: One commenter recommended that CMS evaluate whether the 
managed care plans and ombudsman appeals processes in states with 
separate CHIP programs sufficiently address the access and quality 
barriers faced by children and pregnant women.
    Response: We appreciate the suggestion and will consider such an 
evaluation in the future.
    Comment: Two commenters asked whether states could continue 
benefits for Title XXI enrollees in the same manner they do for Title 
XIX enrollees, at state option.
    Response: States currently have, and will continue to have the 
option to continue benefits pending appeal.
    Comment: One commenter encouraged CMS to give CHIP contractors the 
option to offer grievance and appeals processes consistent with the 
regulations at 45 CFR 147.136, which applies to Marketplace plans 
stating that this would benefit families who have children on CHIP and 
other family members in QHPs.
    Response: We believe that maximizing alignment between the CHIP and 
Medicaid managed care grievances and appeals regulations is most 
important, and the final CHIP regulations reflect that goal. Wherever 
possible, we also have sought to align the grievances and appeals 
procedures across different health coverage, so the Medicaid and CHIP 
regulations also largely align with regulations for QHPs at 45 CFR 
147.136 and Medicare Advantage regulations in 42 CFR part 422, subpart 
M. When the regulations for Medicaid and/or CHIP do not align with the 
regulations governing plans participating in other programs or markets, 
we have made a determination that a different policy is required or 
appropriate and states must ensure that the CHIP plans with which they 
contract comply with the terms of the CHIP regulations.
    After consideration of the public comments, we are finalizing Sec.  
457.1260 substantively as proposed but with minor revisions for 
clarity.
24. Sanctions (Sec.  457.1270)
    Section 2103(f)(3) of the Act, as amended by section 403 of CHIPRA, 
specifies that the sanctions provisions at section 1932(e) of the Act 
apply to CHIP managed care programs. As such, we proposed to align CHIP 
with the Medicaid sanctions sections at subpart I of part 438, which 
effectuate section 1932(e) of the Act. We proposed adding Sec.  
457.1270, which provides that states must ensure that MCOs, PAHPs, and 
PIHPs comply with the Medicaid sanctions.in accordance with the terms 
of subpart I of part 438.
    We received the following comment in response to our proposal to 
add Sec.  457.1270.
    Comment: One commenter supported adopting the Medicaid sanctions 
standards in subpart I of part 438.
    Response: We appreciate the support of this proposal.
    After consideration of the public comments, we are finalizing Sec.  
457.1270 substantively as proposed, with minor revisions for clarity.
25. Program Integrity--Conditions Necessary To Contract as an MCO, 
PAHP, or PIHP (Sec. Sec.  457.955, 457.1280, and 457.1285)
    Section 2107 of the Act includes several program integrity 
standards, including sections 2107(b), 2107(e)(1)(D), and 2107(e)(2) of 
the Act. We proposed to effectuate those standards by adopting many of 
the Medicaid program integrity standards in CHIP. In addition, we 
proposed to maintain but relocate the current CHIP regulations related 
to managed care program integrity.
    We proposed to redesignate all of Sec.  457.955 as Sec.  457.1280. 
Section Sec.  457.955 was located in the general CHIP program integrity 
subpart I. Because the section specifies conditions necessary for 
entities to contract as an MCO, PAHP, PIHP, we proposed to move it to 
the new subpart L. We proposed several minor changes to the regulation 
text: (1) To update references to MCE to MCO, PAHP, or PIHP; (2) to add 
at paragraph (b)(1) that MCOs, PAHPs, and PIHPs must comply with 
applicable state and Federal statutes and regulations, in addition to 
complying with state and Federal standards; and (3) to add at paragraph 
(b)(3) that there must be mechanisms for MCOs, PAHPs,

[[Page 27769]]

and PIHPs to report providers to the state.
    We also proposed to adopt nearly all of the of the Medicaid program 
integrity standards. In Sec.  457.1285, we proposed to adopt subpart H 
of part 438, with the exception of Sec.  438.604(a)(2), which does not 
apply because we did not propose to adopt in CHIP all of the Medicaid 
actuarial soundness requirements.
    We received the following comments in response to our proposal to 
redesignate Sec.  457.955 as new Sec.  457.1280 and to newly proposed 
Sec.  457.1285.
    Comment: Several commenters expressed support for the alignment of 
the CHIP managed care program integrity standards at Sec.  457.1280 and 
Sec.  457.1285.
    Response: We appreciate the support.
    Comment: Some commenters noted that the instructions for the 
redesignation of Sec.  457.955 at Sec.  457.1280 and revision of newly 
designated Sec.  457.1280, erroneously refer to subpart K instead of 
subpart L.
    Response: We agree that references to subpart K should be to 
subpart L.
    Comment: One commenter expressed concern that the proposed 
provision at Sec.  457.1280(d) related to the ability of States to 
inspect, evaluate and audit MCOs, PIHPs and PAHPs could limit broader 
existing contractual arrangements. The commenter noted that some states 
currently require all subcontracts to include a provision allowing the 
State and federal governments to audit. Therefore, the commenter 
suggested that CMS refrain from creating a new ``reasonable possibility 
of fraud'' standard related to the right to audit. The commenter 
recommended that CMS revise the language at Sec.  457.1280(b)(3) to end 
after ``at any time,'' eliminating the phrase ``as necessary, in 
instances where the State determines that there is a reasonable 
possibility of fraudulent and abusive activity.''
    Response: We did not propose to modify the current regulations at 
Sec.  457.955(d) which we proposed to redesignate at Sec.  457.1280(d) 
and are not revising this paragraph in the final rule. We disagree with 
the commenter's view that Sec.  457.1280(d) is too limiting. Both Sec.  
457.1201(g) and Sec.  457.1233(b) (incorporating, by cross-reference 
Sec.  438.208(c)(3)) of the final rule) give states and other oversight 
bodies a broad right to inspect the records and facilities of MCOs, 
PAHPs, PIHPs, PCCMs and PCCM entities and their subcontractors. Under 
proposed Sec.  457.1280(d), states have the latitude to conduct an 
inspection at any time there is a suspicion of possible fraud or abuse; 
as such we have revised the regulation text to read that the State may 
inspect, evaluate, and audit MCOs, PIHPs, and PAHPs at any time, where 
the state determines that there is a reasonable possibility of 
``fraudulent or abusive activity'' rather than ``fraudulent and abusive 
activity.'' Additionally, States are responsible for exercising general 
oversight over plans' compliance with their contracts and adherence to 
federal and state laws, regulations and policies, not only when fraud 
or abuse is suspected.
    Comment: Several commenters expressed support for the application 
of subpart H of part 438 to CHIP at Sec.  457.1285. In contrast, some 
commenters expressed concern about adopting some of the standards in 
subpart H, particularly Sec.  438.602(b) related to screening and 
enrolling providers, Sec.  438.602(c) related to state review of 
ownership and control disclosures submitted by subcontractors, Sec.  
438.602(d) related to performance of federal database checks, and Sec.  
438.602(e) related to periodic audits of contractors to be conducted 
not less than every 3 years. The commenter suggested that the NAIC 
standard of not less than every 5 years was more appropriate for CHIP.
    Response: We decline to exempt states from the oversight 
responsibilities of managed care plans set forth in Sec.  438.602(b) 
through (e). We note that the standards in Sec.  438.602(b) through (d) 
already apply to CHIP through Sec.  457.935 and Sec.  457.990. Section 
457.935 applies to CHIP part 455, subpart B, which includes the 
ownership and control disclosures. Section 457.990 applies to CHIP part 
455, subpart E, which includes the screen and enroll and federal data 
base check standards. In addition, because a major goal of this 
regulation is alignment between Medicaid and CHIP, we decline to adopt 
the NAIC standard for periodic audits rather than the Medicaid 
standard.
    After consideration of the public comments, we are finalizing Sec.  
457.1280 as proposed, except that we are removing the final clause from 
Sec.  457.1280(d) and specifying that states may inspect, evaluate, and 
audit MCOs, PIHPs, and PAHPs at any time, when a state determines there 
is a reasonable possibility of fraudulent ``or'' abusive activity as 
discussed in the comments above. We are also finalizing Sec.  457.1285 
as proposed.

III. Third Party Liability

A. Background

    Medicaid is the payer of last resort. This means that other 
available resources--known as third party liability, or TPL--must be 
used before Medicaid pays for services received by a Medicaid-eligible 
individual. Title XIX of the Act requires state Medicaid programs to 
identify and seek payment from liable third parties, before billing 
Medicaid. Specifically, section 1902(a)(25)(A) of the Act requires that 
states take all reasonable measures to ascertain legal liability of 
third parties to pay for care and services available under the plan. 
That provision further specifies that a third party is any individual, 
entity, or program that is or may be liable to pay all or part of the 
expenditures for medical assistance furnished under a state plan.
    Examples of liable third parties include private insurance 
companies through employment-related or privately purchased health 
insurance; casualty coverage resulting from an accidental injury; 
payment received directly from an individual who has voluntarily 
accepted or been assigned legal responsibility for the health care of 
one or more Medicaid recipients; fraternal groups, unions, or state 
workers' compensation commissions; and medical support provided by a 
parent under a court or administrative order. Section 1902(a)(25)(A)(i) 
of the Act specifies that the state plan must provide for the 
collection of sufficient information to enable the state to pursue 
claims against third parties.
    To support identification of TPL, and under the authority of in 
section 1902(a)(25)(A) of the Act, we issued regulations at Sec.  
433.138 in 1987 that established requirements for state Medicaid 
agencies to obtain information via data matching with the state workers 
compensation files or state motor vehicle accident reports. 
Additionally, we required states to identify all paid claims indicative 
of trauma as identified by diagnosis codes found in ICD-9-CM, 800 
through 999, except 994.6.
    Section 433.138(e) specifically references the use and application 
of the ICD-9-CM medical coding system to assist in identifying liable 
third parties as primary payers before Medicaid. By 1990, however, we 
realized it had been too prescriptive to require states to review all 
ICD-9-CM trauma codes, and amended Sec.  433.138 to allow states to 
submit waiver requests to cease editing codes proven to be unproductive 
in identifying liable third parties. States have over 25 years of 
experience identifying trauma codes indicating the likelihood of third 
party liability, which contributes to payment of Medicaid expenses.
    In 1990, the World Health Organization (WHO) approved the 
International Classification of Diseases,

[[Page 27770]]

10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, 
including the Official ICD-10-CM Guidelines for Coding and Reporting, 
and the International Classification of Diseases, 10th Revision, 
Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure 
coding, including the Official ICD-10-PCS Guidelines for Coding and 
Reporting (collectively, ICD-10). In 2009, the Secretary adopted ICD-10 
as the Health Insurance Portability and Accountability Act of 1996 
(HIPAA) standard code set to replace ICD-9-CM with an October 1, 2013 
compliance date. The compliance date was delayed until October 1, 2014 
and again until October 1, 2015 in subsequent rules. All HIPAA covered 
entities are now required to use ICD-10 to code claims with dates of 
service on or after the ICD-10 compliance date of October 1, 2015

B. Summary of Proposed Provisions and Analysis of and Responses to 
Comments

    In the June 1, 2015 proposed rule (80 FR 31175 through 31176), we 
proposed to address third party liability for trauma codes. Brief 
summaries of each proposed provision, a summary of the public comments 
we received (with the exception of specific comments on the paperwork 
burden or the economic impact analysis), and our responses to the 
comments are as follows. Comments related to the paperwork burden and 
the impact analyses are addressed in the ``Collection of Information 
Requirements'' and ``Regulatory Impact Analysis'' sections in this 
final rule.
    Section 433.138(e), requiring the use of ICD-9-CM coding, had to be 
amended to account for the implementation of ICD-10 coding for health 
services provided on or after October 1, 2015. We considered ways to 
best achieve this, keeping in mind that states bear the responsibility 
for interpreting and applying the increased number of new ICD-10 codes 
and that state Medicaid programs need greater discretionary authority 
in developing trauma code edits to best identify liable third parties 
and achieve the highest TPL return from their efforts. We reviewed 
previous regulatory amendments, which demonstrated a progression from 
explicit federally-prescribed requirements to less prescriptive 
approaches that, while maintaining the federal designation of trauma 
codes subject to review, allowed states to propose waivers of editing 
for trauma codes that were not cost-effective to pursue.
    This regulation was last amended in 1995 to remove trauma code-
specific waiver authority from Sec.  433.138(e) and add Sec.  
433.138(l), establishing the possibility of waiver of non-statutory 
requirements in Sec. Sec.  433.138 and 433.139, including Sec.  
433.138(e), permitting states to request adjustments to any of several 
non-statutory requirements, including the code editing requirements, if 
they determined the activity to not be cost-effective. Section 
433.138(l) specified that an activity would not be cost-effective if 
the cost of the required activity exceeded the TPL recoupment and the 
required activity accomplishes, at the same or at a higher cost, the 
same objective as another activity that is being performed by the 
state.
    The background information in the preamble for the regulatory 
amendment published in the July 10, 1995 Federal Register (60 FR 35498 
through 35503) affirmed that we had been prescriptive in the initial 
1987 regulations for trauma code editing, explaining that TPL was then 
in its ``infancy'' and there was concern that states were not 
identifying instances of traumatic injury for which a liable third 
party might exist. By 1995, when the last amendment to the trauma code 
was proposed, we acknowledged that states had other means of 
identifying potential TPL for trauma cases, including federally-
required data matches with state motor vehicle administration accident 
files and with state worker's compensation files, and that the majority 
of states have aggressive and comprehensive TPL programs. It has been 
almost 20 years since we last amended the regulations for trauma code 
editing. States' information technology systems have greatly improved 
to support refined procedures to identify instances where a Medicaid 
beneficiary's traumatic injury may result in a liable third party.
    The proposed revision amendment to Sec.  433.138(e), which would 
remove references to ICD-9-CM, offered an opportunity to make a 
substantive change to this regulation while affirming the continued 
responsibility of state Medicaid programs to identify trauma-related 
claims to determine TPL and ensure that state Medicaid programs remain 
secondary payers. Therefore, we proposed to replace the reference to a 
specific coding system with a general description of the types of 
medical diagnoses indicative of trauma for which states are expected to 
edit claims. This revision did not propose that any state change its 
current trauma code editing process with regard to codes that the state 
has identified as not yielding third party recoveries and that CMS has 
agreed the state may discontinue editing. In Sec.  433.138(e)(1), we 
proposed to remove the reference to the ICD-9-CM code range 800 through 
999 that defined the codes that were indicative of traumatic injury. 
The ICD-9-CM coding system has now been replaced by the ICD-10 coding 
system, which had an October 1, 2015 compliance date.
    We proposed to retain the regulatory references to complete trauma 
code editing and the state's ability to request a waiver of these 
requirements to adjust the trauma code editing process beyond the scope 
allowed by these changes to Sec.  433.138(e).
    We also proposed to remove Sec.  433.138(e)(2), as the regulation 
specifically refers to exclusion of the ICD-9-CM code for motion 
sickness for consistency with the proposal to remove all references to 
ICD-9-CM-specific coding in this section. The deletion of paragraph 
(e)(2) of Sec.  433.138 would eliminate the necessity to identify the 
remaining regulatory text as Sec.  433.138(e)(1), so we proposed to 
delete paragraph (e)(1).
    We received the following comments in response to our proposal to 
revise Sec.  433.138.
    Comment: Several commenters supported the removal of a specific 
diagnostic coding system for trauma code editing to identify TPL. Most 
commenters agreed that states have expertise in this area and can 
perform effective and efficient trauma code editing. One commenter 
added that this change allows for non-regulatory/statutory adjustments 
to accommodate future changes to new diagnostic coding systems.
    Response: We thank commenters for their support.
    Comment: A few commenters requested clarification if states would 
be required to obtain a waiver from CMS to discontinue review of each 
diagnostic code indicative of trauma.
    Response: We are not requiring states to obtain a waiver to 
discontinue the review of trauma codes that states determine are not 
cost-effective. We are available to provide technical assistance to 
states.
    Comment: A few commenters requested clarification on the TPL rights 
of managed care plans, including requiring third parties to treat a 
managed care plan as if it were the state Medicaid agency with regard 
to sharing information to identify Medicaid beneficiaries with third 
party coverage; accepting the state's assignment to the managed care 
plan of the right to third party payments, including the right to 
recover overpayments; and refraining from denying payment of claims for 
procedural reasons.

[[Page 27771]]

    Response: The requested clarifications are outside the scope of the 
trauma code editing regulation, but we note that CMS published guidance 
in 2012 on Medicaid.gov affirming that a managed care plan should be 
treated as if it were the state Medicaid program when the state has 
delegated responsibility and authority to perform TPL functions to the 
managed care plan. We also note that states have wide latitude in 
deciding what, if any, required Medicaid coordination of benefits/TPL 
functions they will delegate to the managed care plans, and third 
parties may request confirmation from the state of the delegation of 
authority.
    Comment: One commenter requested that the final rule include CMS 
facilitation of multi-payer collaboration tools to assist coordination 
of benefits by all payers, including Medicare and TRICARE. The 
commenter also requested alignment of timely filing limits across 
Medicare and TRICARE, and more consistency among state claims filing 
limits.
    Response: These requests are outside the scope of the trauma code 
editing regulation, however we note that federal law requires states to 
have laws that establish a claims filing period for the state Medicaid 
program of not less than 3 years. It is up to each state to determine 
if a longer period is appropriate for its Medicaid program.
    Comment: One commenter requested that CMS limit managed care plans' 
``look-back'' period to recoup payments from providers of pharmacy 
services to no more than 18 months when a beneficiary's third party 
coverage is identified after the managed care plan has paid for the 
service. The commenter also requested that CMS approve a new method for 
managed care plans to obtain third party payment for pharmacy services 
in this circumstance. The commenter suggested that managed care plans 
be allowed to use the Medicaid pharmacy subrogation transaction (45 CFR 
162.1901) currently used by state Medicaid programs to submit claims.
    Response: The requested clarifications are outside the scope of the 
trauma code editing regulation.
    Comment: One commenter requested that CMS require states to 
implement systems and procedures that protect the confidentiality of a 
Medicaid beneficiary who has refused to provide information about third 
party resources to support Medicaid's coordination of benefits with 
third parties, under the ``good-cause exception'' to this requirement. 
The requested protection would extend to use of means such as 
electronic records and databases to identify and bill third parties. 
The commenter also requested that states ensure that managed care plans 
are informed of the good-cause exception. The commenter noted that 
federal statute and regulation already exists to require exemption from 
the required identification of third party resources when there is good 
cause.
    Response: The requested clarifications are outside the scope of the 
trauma code editing regulation, but we note that federal statute and 
regulation allow a beneficiary to request an exemption for good cause, 
as the commenter indicates.
    After consideration of the public comments, we are finalizing Sec.  
433.138(e) as proposed.

IV. Finding of Good Cause; Waiver of Delay in Effective Date

    Under 5 U.S.C. 553(d) of the Administrative Procedure Act (APA), 
there is a mandatory minimum 30-day delay in effective date after 
issuance or publication of a rule. This 30-day delay in the effective 
date can be waived, however, if an agency finds for good cause that the 
delay is impracticable, unnecessary or contrary to the public interest, 
and the agency incorporates a statement of the finding and its reasons 
in the rule issued. Under 5 U.S.C. 801 et seq., the Congressional 
Review Act also mandates a 60-day delay in effective date of major 
rules. However, this statute also provides an exception for the 
mandatory delay when the agency finds good cause. 5 U.S.C. 808(2). The 
rules finalized here at Sec. Sec.  433.15(b)(10) and 438.370, regarding 
the amount of federal financial participation available for the cost of 
external quality review and related activities performed in connection 
with managed care plans that are not Medicaid managed care 
organizations (MCOs), are effective immediately based on a finding that 
it is contrary to the public interest to delay the effective date of 
these provisions.
    These regulations governing the amount of federal financial 
participation are based on section 1903(a)(3)(C)(ii) and 1903(a)(7) of 
the Act. Section 1903(a)(3)(C)(ii) of the Act provides a 75 percent 
rate for federal financial participation for costs ``attributable to 
the performance of independent external reviews conducted under section 
1932(c)(2)'' while section 1903(a)(7) of the Act provides a 50 percent 
rate for federal financial participation for costs of the 
administration of the state plan. Section 1932(c)(2) of the Act 
requires external quality review of MCOs and refers specifically both 
to MCOs and contracts under section 1903(m) of the Act, which, in turn, 
authorizes MCO contracts. Neither section 1903(a)(3)(C)(ii) of the Act 
nor section 1932(c)(2) of the Act mention or require additional review 
of non-MCO contracts, such as contracts with pre-paid inpatient health 
plans (PIHPs), pre-paid ambulatory health plans (PAHPs), or primary 
care case managers (PCCMs or PCCM entities). Therefore, the cost of 
external quality review of these non-MCO contracts is eligible only for 
the 50 percent match rate authorized by section 1903(a)(7) of the Act. 
Payment of an amount in excess of what is authorized under section 
1903(a)(7) of the Act is beyond our authority and could constitute an 
improper payment. Having recognized the limits of section 
1903(a)(3)(C)(ii) of the Act and the applicability of section 
1903(a)(7) of the Act--and the 50 percent match rate--to the cost of 
external quality review of non-MCO contracts, we lack authority to 
continue paying federal financial participation at the higher rate. 
Continuing to make payment in unauthorized amounts is contrary to the 
public interest. Therefore, we find that there is good cause to waive 
the requirement for a delay in the effective date of the rules 
finalized here at Sec. Sec.  433.15(b)(10) and 438.370.

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
publish a 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval.
    To fairly evaluate whether an information collection should be 
approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit 
comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be 
collected.
     Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    Our June 1, 2015 proposed rule (80 FR 31098) solicited public 
comment on each of the section 3506(c)(2)(A)-required issues for the 
following information collection requirements (ICRs) in this final 
rule. PRA-related comments were received and are summarized below along 
with our response. The comments addressed

[[Page 27772]]

requirements/burden proposed under part 438.

A. Background

    The burden associated with the requirements under part 438 is the 
time and effort it will take each of the Medicaid programs to comply 
with this rule's requirements. More specifically, this rule revises the 
Medicaid managed care regulations to implement statutory provisions, 
strengthens actuarial soundness and other payment regulations improving 
accountability of rates paid in the Medicaid managed care program, 
implements changes supporting alignment with other public and insurance 
affordability programs, strengthens beneficiary protections, and 
modernizes the regulations recognizing changes in usage of managed care 
delivery systems since the release of the part 438 final rule in 2002.
    Section 433.138(e)(1) makes a technical correction addressing state 
Medicaid agencies' review of claims with trauma codes, to identify 
instances where third party liability (TPL) may exist for expenditures 
for medical assistance covered under the state plan. The correction 
will remove references to the International Classification of Disease, 
9th edition, Clinical Modification Volume 1 (ICD-9-CM) by replacing the 
references with a general description of the types of medical diagnoses 
indicative of trauma. States must use the International Classification 
of Disease that they are using at the time of claims processing. There 
is no additional cost to the state related to the changes to Sec.  
433.138(e) since the changes do not require any action by the state, if 
the state wishes to continue editing for the same types of traumatic 
injuries currently identified with ICD-9-CM codes after the conversion 
of the claims processing system to ICD-10 codes. Further, since trauma 
code editing is based on current MMIS claims processing, revisions to 
accommodate the coding system change from ICD-9-CM to ICD-10 are 
already in progress as a required adjustment of each state's MMIS. This 
final rule allows states to make adjustments to certain TPL activities 
without preparing a formal waiver request to seek CMS's permission. 
There is no requirement for a state to make such adjustments.
    The June 1, 2015 proposed rule (80 FR 31098) included a proposed 
part 431 subpart I, which laid out the requirements for the proposed 
comprehensive quality strategy, which would have applied to all 
services covered under state Medicaid programs, not just those covered 
through an MCO or PIHP. The burden associated with proposed Sec. Sec.  
431.502 and 431.504 was captured in ICRs 1 and 2 of the proposed rule. 
Based upon comments received in response to the proposed rule, we have 
withdrawn the proposal for a comprehensive quality strategy that 
applied to Medicaid services delivered by FFS and managed care (see 
discussion in section I.B.6.b(2)(f)). We are retaining the requirement 
in Sec.  438.340 of the final rule for a quality strategy that 
addresses services delivered by MCOs, PIHPs, PAHPs, and PCCM entities 
described in Sec.  438.310(c)(2) of the final rule. As appropriate, 
burden estimates from proposed part 431 subpart I are moved to the 
burden estimate for Sec.  438.340 of the final rule, with revisions 
based on the application to only managed care.
    We have added a new subpart L to part 457, which contains the 
regulations related to CHIP managed care plans. While most of the 
requirements in this subpart are new, we have also moved portions of 
Sec.  457.950 and all of Sec.  457.955 from subpart I to the new 
subpart L. This will ensure that all related information is contained 
in one subpart.
    Burden estimates for Part 438 utilized enrollment, managed care 
plan, and state data for CY 2012 from the MSIS. Enrollment data was 
trended forward as appropriate for certain estimates utilizing a 3.3 
percent annual growth rate as determined by the Office of the Actuary. 
The enrollment data reflected 31,827,858 enrollees in MCOs, 12,116,645 
enrollees in PIHPs, 1,0985,021 enrollees in PAHPs, and 7,775,297 
enrollees in PCCMs, for a total of 62,704,821 managed care enrollees. 
This includes duplicative counts when enrollees are enrolled in 
multiple managed care plans concurrently. This data also showed 36 
states that contract with 335 MCOs, 20 states that contract with 176 
PIHPs, 12 states that contract with 41 PAHPs, 18 states that contract 
with 20 non-emergency transportation PAHPs, 25 states with 25 PCCM and 
9 PCCM entities, and 16 states that contract with one or more managed 
care plan for MLTSS. Many states contract with more than one entity; 
however, we de-duplicated to determine that 40 states contract with 
MCOs, PIHPs, and/or PAHPs; and 42 states contract with MCOs, PIHPs, 
PAHPs, and/or PCCMs.

B. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2014 National Occupational Employment and Wage 
Estimates for all salary estimates (www.bls.gov/oes/current/oes_nat.htm). Table 1 presents the mean hourly wage, the cost of fringe 
benefits (calculated at 100 percent of salary), and the adjusted hourly 
wage.

[[Page 27773]]

[GRAPHIC] [TIFF OMITTED] TR06MY16.000

    As indicated, we are adjusting our employee hourly wage estimates 
by a factor of 100 percent. This is necessarily a rough adjustment, 
both ecause fringe benefits and overhead costs vary significantly from 
employer to employer, and because methods of estimating these costs 
vary widely from study to study. Nonetheless, there is no practical 
alternative and we believe that doubling the hourly wage to estimate 
total cost is a reasonably accurate estimation method.

C. Information Collection Requirements (ICRs)

1. ICRs Regarding Standard Contract Requirements (Sec. Sec.  438.3, 
438.10(c)(5), 438.14(b), 438.110(a), 438.210(b)(2)(iii), 438.242(c), 
438.402 and 438.608)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.3 contains a list of provisions that must be included 
in MCO, PIHP, PAHP, HIO, and/or PCCM contracts. While the burden 
associated with the implementation and operation of the contracts is 
set out when warranted under the appropriate CFR section, the following 
burden estimate addresses the effort to amend existing contracts. The 
estimate also includes the burden for additional contract amendments 
are required under:
     Sec.  438.10(c)(5) requires specific information to be 
provided to enrollees.
     Sec.  438.14(b) specifies requirements for Indian 
enrollees and providers.
     Sec.  438.110(a) requires the establishment and 
maintenance of member advisory committees.
     Sec.  438.210(b)(2)(iii) requires LTSS to be authorized 
consistent with the enrollee's needs assessment and person centered 
plan.
     Sec.  438.242(c) requires specific provisions for 
encounter data.
     Sec.  438.608 requires administrative and management 
arrangements and procedures to detect and prevent fraud, waste, and 
abuse.
    We estimate a one-time state burden of 6 hr at $64.46/hr for a 
business operations specialist to amend all contracts. In aggregate, we 
estimate 3,636 hr (335 MCO + 176 PIHP + 61 PAHP + 34 PCCM contracts x 6 
hr) and $234,376.56 (3,636 hr x $64.46/hr).
    We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires.
2. ICRs Regarding Rate Standards (Sec.  438.5)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.5 describes the development and documentation of 
capitation rates paid to risk-based MCOs, PIHPs and PAHPs. Generally, 
we require: The use of appropriate base data; the application of trends 
that have

[[Page 27774]]

a basis in actual experience; a comprehensive description of the 
development of the non-benefit component of the rate; descriptions of 
the adjustments applied to the base data, rate, or trends; actuarial 
certification of the final contract rates paid to the plans; and a 
description of budget neutral risk adjustment methodologies.
    We believe that the requirements related to the use appropriate 
base data and the adequate description of rate setting standards, such 
as trend, the non-benefit component, adjustments, and risk adjustment, 
are already required as part of actuarial standards of practice and 
accounted for in Sec.  438.7. We clarified that risk adjustment should 
be done in a budget neutral manner, but the manner in which risk 
adjustment is applied should not create additional burden on the state.
    In Sec.  438.5(g), the certification of final contract rates places 
additional burden on the states. We estimate that most states currently 
certify a range as compared to the actual contract rate paid to the 
managed care plan. Therefore, out of the total 70 certifications 
submitted to CMS from 39 states, the process underlying 50 
certifications will need to be modified.
    We estimate it will take approximately 10 hr at $92.44/hr for an 
actuary and 1 hr at $140.80/hr for a general and operations manager to 
comply with this requirement. In aggregate, we estimate an annual state 
burden of 550 hr (50 certifications x 11 hr) and $53,260 [50 
certifications x ((10 hr x $92.44/hr) + (1 hr x $140.80/hr))].
3. ICRs Regarding Rate Certification Submission (Sec.  438.7)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.7 describes the submission and documentation 
requirements for all managed care actuarial rate certifications. The 
certification will be reviewed and approved by CMS concurrently with 
the corresponding contract(s). Section 438.7(b) details CMS' 
expectations for documentation in the rate certifications. We believe 
these requirements are consistent with actuarial standards of practice 
and previous Medicaid managed care rules.
    While the 2002 final rule (under Sec.  438.6(c)) set out the burden 
per contract (15,872 hr based on 32 hr per plan), experience has shown 
that states do not submit certifications per plan. We believe a better 
estimation of the burden is associated with the development of the rate 
certification. In this regard, we estimate it takes 230 hr to develop 
each certification, consisting of 100 hr (at $92.44/hr) for an actuary, 
10 hr (at $140.80/hr) for a general and operations manager, 50 hr (at 
$78.32/hr) for a computer programmer, 50 hr (at $64.46/hr) for a 
business operations specialist, and 20 hr (at $36.54/hr) for an office 
and administrative support worker.
    The revised burden of 228 hours is based on a total of 16,100 hr 
(230 hr x 70 certifications) which is an increase of 228 hr (16,100 hr-
15,872 hr) for all 70 certifications due to the new regulatory 
requirements, adjusted to 3.3 hr per certification (228 hr/70 
certifications). In aggregate, we estimate an annual state burden of 
$18,948.57 [70 certifications x ((1.5 hr x $92.44/hr) + (0.13 hr x 
$140.80/hr) + (0.73 hr x $78.32/hr) + (0.73 hr x $64.46/hr) + (0.26 hr 
x $36.54/hr))]. (Prorating the time of the actuary, general operations 
manager, computer programmer, business operations specialist, and 
office and administrative support worker across the 3.3 hr per 
certification.)#
4. ICRs Regarding Minimum Medical Loss Ratio (Sec.  438.8)
    While one PRA-related public comment was received with regard to 
our proposed requirements and burden estimates, we have considered the 
comment and are adopting the proposed provisions/estimates without 
change. See below for our finalized estimates along with a summary of 
the comment and our response.
    Section 438.8(c) requires that MCOs, PIHPs, and PAHPs report to the 
state annually their total expenditures on all claims and non-claims 
related activities, premium revenue, the calculated MLR, and, if 
applicable, any remittance owed.
    We estimate the total number of MLR reports that MCOs, PIHPs, and 
PAHPs are required to submit to states amount to 572 contracts. While 
the number of contracts includes 549 credible contracts and 23 non-
credible contracts, all MCOs, PIHPs, and PAHPs will need to report the 
information required under Sec.  438.8 regardless of their credibility 
status.
    We estimate a one-time private sector burden of 168 hr for the 
initial administration activities. We estimate that 60 percent of the 
time will be completed by a computer programmer (101 hr at $78.32/hr), 
30 percent will be completed by a business operations specialist (50 hr 
at $64.46/hr), and 10 percent will be completed by a general and 
operations manager (17 hr at $140.80/hr). This amounts to $13,526.92 
((101 hr x $78.32) + (50 hr x $64.46) + (17 hr x $140.80)) per report 
or $7,737,398.24 (572 x $13,526.92) for 572 MCOs, PIHPs, and PAHPs in 
2017 (the one-time burden). We are annualizing the one-time development 
since we do not anticipate any additional burden after the 3-year 
approval period expires.
    In subsequent years, since the programming and processes 
established in 2017 will continue to be used, the burden will decrease 
from 168 hr to approximately 53 hr. Using the same proportions of labor 
allotment, we estimate an annual private sector burden of $4,241.60 per 
report and a total of $2,426,195.20 [572 contracts x $4,241.60 ((32 hr 
x $78.32/hr) + (16 hr x $64.46/hr) + (5 hr x $140.80/hr)]. We expect 
that states will permit MCOs, PIHPs, and PAHPs to submit the report 
electronically. Since the submission time is included in our reporting 
estimate, we are not setting out the burden for submitting the report.
    We received the following comment:
    Comment: We received one comment on the burden estimate for 
proposed Sec.  438.8: ``MCOs report to the state annually their total 
expenditures on all claims and non-claims related activities, premium 
revenue, MLR and remittance owed. $2,185,050.56 [568 contracts x 
$3,846.92 ((32 hr x $73.60/hr) + (16 hr x $53.32/hr)]. The commenter 
believed that this number should account for MCO time and expense 
required to complete financial reporting and encounter data submission 
and believed the estimate only reflected the financial reporting.
    Response: The hours reflected in the estimate are for the 
calculation and reporting requirements proposed in Sec.  438.8(c). The 
estimates quoted in the comment are for continuation of reporting in 
2017 and beyond. The estimates in the COI for 2016 included 115 
additional hours for initial process development and programming. Hours 
for submitting encounter data are not included as that is a requirement 
under existing Sec.  438.242 and the COI only reflects changes in hours 
based on proposed changes. To the extent changes were proposed in Sec.  
438.242, hours were appropriately reflected for that section. We 
decline to revise this estimate.
5. ICRs Regarding Information Requirements (Sec.  438.10)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.

[[Page 27775]]

    Section 438.10(c)(3) requires states to operate a Web site that 
provides the information required in Sec.  438.10(f). Since states 
already have Web sites for their Medicaid programs and most also 
include information about their managed care program, most states will 
only have to make minor revisions to their existing Web site.
    We estimate 6 hr at $78.32/hr for a computer programmer to make the 
initial changes. In aggregate, we estimate a one-time state burden of 
252 hr (42 states x 6 hr) and $19,736.64 (252 hr x $78.32/hr). We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. We also 
estimate 3 hr for a computer programmer to periodically add or update 
documents and links on the site. In subsequent years, we estimate an 
annual state burden of 126 hr (42 states x 3 hr) and $9,868.32 (126 hr 
x $78.32/hr).
    Section 438.10(c)(4)(i) recommends that states develop definitions 
for commonly used terms to enhance consistency of the information 
provided to enrollees. We estimate it will take 6 hr at $64.46/hr for a 
business operations specialist to develop these definitions. In 
aggregate, we estimate a one-time state burden of 252 hr (42 states x 6 
hr) and $16,243.92 (252 hr x $64.46/hr). We are annualizing the one-
time development since we do not anticipate any additional burden after 
the 3-year approval period expires.
    Section 438.10(c)(4)(ii) recommends that states create model 
enrollee handbooks and notices. Since many states already provide model 
handbooks and notices to their entities, we estimate 20 states may need 
to take action to comply with this provision. We estimate it will take 
20 hr at $64.46/hr for a business operations specialist to create these 
documents. We also estimate 2 hr per year for a business operations 
specialist to revise these documents, if needed. In aggregate, we 
estimate a one-time state burden of 400 hr (20 states x 20 hr) and 
$25,784 (400 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires. In subsequent years we estimate an 
annual burden of 40 hr (20 states x 2 hr) and $2,578.40 (40 hr x 
$64.46/hr).
    Section 438.10(d)(2)(i) requires that states add taglines to all 
printed materials for potential enrollees explaining the availability 
of translation and interpreter services as well as the phone number for 
choice counseling assistance. As the prevalent languages within a state 
do not change frequently, we are not estimating the burden for the rare 
updates that will be needed to update these taglines. We estimate it 
will take 2 hr at $64.46/hr for a business operations specialist to 
create the taglines and another 4 hr to revise all document originals. 
In aggregate, we estimate a one-time state burden of 252 hr (42 states 
x 6 hr) and $16,243.92 (252 hr x $64.46/hr). We are annualizing the 
one-time development since we do not anticipate any additional burden 
after the 3-year approval period expires.
    Section 438.10(e)(1) clarifies that states can provide required 
information in paper or electronic format. As this is an existing 
requirement, the only burden change we estimate is adding two new 
pieces of information generated in Sec.  438.68 (network adequacy 
standards) and Sec.  438.330 (quality and performance indicators). We 
estimate 1 hr at $64.46/hr for a business operations specialist to 
update or revise existing materials and 1 min at $30.92/hr for a mail 
clerk to mail the materials to 5 percent of the enrollees that are new 
(3,135,242). In aggregate, we estimate a one-time state burden of 42 hr 
(42 states x 1 hr) and $2,707.32 (42 hr x 64.46/hr) to update/revise 
existing materials. We are annualizing the one-time development since 
we do not anticipate any additional burden after the 3-year approval 
period expires. The currently approved burden estimates 5 min per 
mailing for 65,000 total hour. By updating the enrollment count from 
the current burden estimate to 2,069,259 (62,704,821 total enrollees x 
.033 growth rate) and reducing the time from 5 min to 1 min (to 
acknowledge automated mailing processes), we estimate the annual state 
burden for mailing as -30,512 hr (34,488 hr - 65,000 hr) and -
$943,431.04 (-30,512 hr x $30.92/hr).
    Section 438.10(g)(1) requires that MCOs, PIHPs, PAHPs, and PCCMs 
provide an enrollee handbook. Since Sec.  438.10(g) has always required 
the provision of this information (although it did not specifically 
call it a ``handbook''), we believe only new managed care entities will 
need to create this document. Given the requirement in Sec.  
438.10(c)(4)(ii) for the state to provide a model template for the 
handbook, the burden on a new entity will be greatly reduced.
    For existing entities that already have a method for distributing 
the information, we believe that 100 entities will need to modify their 
handbook to comply with a new model provided by the state. We estimate 
that 100 entities rely on a business operations specialist to spend 4 
hr at $64.46/hr to update their handbook. Once revised, the handbooks 
need to be sent to enrollees. We estimate 1 min by a mail clerk at 
$32.23/hr to send handbooks to 10,659,819 enrollees (17 percent of 
62,704,821 total enrollment). To update the handbook, we estimate a 
one-time private sector burden of 400 hr (100 entities x 4 hr) and 
$25,784 (400 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires. To send the handbook to existing 
enrollees in the 100 entities, we estimate a one-time private sector 
burden of 178,019 hr (10,659,819 enrollees x 1 min) and $5,504,346.78 
(178,019 hr x $30.92/hr). We are annualizing the one-time development 
since we do not anticipate any additional burden after the 3-year 
approval period expires.
    With regard to new enrollees, they must receive a handbook within a 
reasonable time after receiving notice of the beneficiary's enrollment. 
We assume a 3.3 percent enrollee growth rate thus 2,069,259 enrollees 
(3.3% percent of 62,704,821) will need to receive a handbook each year. 
We estimate 1 min by a mail clerk at $30.92/hr to mail the handbook or 
34,557 hr (2,069,259 enrollees x 1 min). The currently approved burden 
estimates 5 min per mailing for 390,000 enrollees or 32,500 total hour. 
Updating the enrollment figure and reducing the time from 5 min to 1 
min (to acknowledge current automated mailing processes), the annual 
private sector burden is increased by 2,057 hr (34,557 hr - 32,500 hr) 
and $63,602.44 (2,057 hr x $30.92/hr).
    Since all of the 335 MCO + 176 PIHP + 61 PAHP + 9 PCCM entities 
will need to keep their handbook up to date, we estimate it will take 1 
hr at $64.46/hr for a business operations specialist to update the 
document. While the updates are necessary when program changes occur, 
we estimate 1 hr since each change may only take a few minutes to make. 
In aggregate, we estimate an annual private sector burden of 581 hr 
(335 MCO + 176 PIHP + 61 PAHP + 9 PCCM entities x 1 hr) and $37,451.26 
(581 hr x $64.46/hr).
    Section 438.10(h) requires that all MCO, PIHP, PAHP, and PCCM 
entities make a provider directory available in electronic form, and on 
paper upon request. Producing a provider directory is a longstanding 
requirement in Sec.  438.10 and in the private health insurance market. 
Given the time sensitive nature of provider information and the high 
error rate in printed directories, most provider information is now 
obtained via the Internet or by calling a customer service 
representative. In this regard, the only

[[Page 27776]]

new burden is the time for a computer programmer to add a few 
additional fields of data, including the provider Web site addresses, 
additional disability accommodations, and adding behavioral and long-
term services and support providers.
    We estimate that it takes approximately 1 hr at $78.325/hr for a 
computer programmer to update the existing directory. Updates after the 
creation of the original program will be put on a production schedule 
as part of usual business operations and would not generate any 
additional burden. In aggregate, we estimate a one-time private sector 
burden of 581 hr (335 MCO + 176 PIHP + 61 PAHP + 9 PCCM entities x 1 
hr) and $45,503.92 (581 hr x $78.32/hr). We are annualizing the one-
time development since we do not anticipate any additional burden after 
the 3-year approval period expires.
6. ICRs Regarding Requirements That Apply to MCO, PIHP, PAHP, and PCCM 
Contracts Involving Indians, Indian Health Care Providers, and Indian 
Managed Care Entities (Sec.  438.14)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.14(c) requires states to make supplemental payments to 
Indian providers if the MCO, PIHP, PAHP, and PCCM entity does not pay 
at least the amount paid to Indian providers under the FFS program. 
There are approximately 31 states with 463 managed care entities with 
Indian providers. This type of payment arrangement typically involves 
the managed care entity sending a report to the state that then 
calculates and pays the amount owed to the Indian health care provider.
    We estimate it takes 1 hr at $78.32/hr for a private sector 
computer programmer to create the claims report and approximately 12 hr 
at $64.46/hr for a state business operations specialist to process the 
payments. We estimate that approximately 25 of the 31 states will need 
to use this type of arrangement; the remaining six require the managed 
care plan to pay the full amount due to the IHCP and no supplemental is 
needed. In aggregate, we estimate a one-time private sector burden of 
463 hr (463 entities x 1 hr) and $36,262.16 (463 hr x $78.32/hr). We 
are annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. We also 
estimate an annual state burden of 300 hr (25 states x 12 hr) and 
$19,338 (300 hr x $64.46/hr).
    After the MCO, PIHP, PAHP, and PCCM report is created, it will most 
likely run automatically at designated times and sent electronically to 
the state as the normal course of business operations; therefore, no 
additional private sector burden is estimated after the first year. 
(Note: this process is not necessary when the MCO, PIHP, PAHP, or PCCM 
entity pays the IHCP at least the full amount owed under this 
regulation.)
7. ICRs Regarding Managed Care Enrollment (Sec.  438.54)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with revisions and minor 
adjustments to hourly rates. No comments were received.
    Section 438.54(c)(3) and (d)(3) requires states to notify the 
potential enrollee of the implications of not making an active choice 
during the allotted choice period. This information should be included 
in the notice of eligibility determination (or annual redetermination) 
required under Sec.  445.912, thus no additional burden is estimated 
here.
    Section 438.54(c)(8) requires states to send a notice to enrollees 
in voluntary programs that utilize a passive enrollment process 
confirming their managed care enrollment when the enrollee's initial 
opportunity to select a delivery system has ended. We assume 15 states 
will continue using a passive enrollment process, with a total of 
22,394,579 enrollees. Assuming that 5 percent of these will be new each 
year, and of those, approximately 75 percent will not take action 
within the allotted time and will remain enrolled in the managed care 
plan passively assigned by the state (22,394,579 x 0.05 x 0.75 = 
839,797) we estimate 1 min per notification by a mail clerk at $30.92/
hr. In aggregate, we estimate an annual state burden of 9,350 hours 
(839,797 enrollees x 1 min) and $433,640.94 (14,025 hr x $30.92/hr).
    In Sec.  438.54(c)(2), our proposed rule had set out requirements 
and burden which would have required states having voluntary programs 
that use a passive enrollment process to provide a 14 day choice period 
before enrolling the potential enrollee into a managed care plan. To 
accommodate the 14 day choice period, we estimated that 15 states would 
have to alter the programming of their passive enrollment algorithm to 
delay the enrollment in a managed care plan until the enrollee makes a 
plan selection or the 14 day period expires. This burden estimate has 
been deleted because the 14 day choice period is not being finalized. 
This is discussed in section I.B.5.a.
8. ICRs Regarding Continued Services to Beneficiaries (Sec.  438.62)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.62(b)(1) requires states to have a transition of care 
policy for all beneficiaries moving from FFS Medicaid into a MCO, PIHP, 
PAHP or PCCM, or when an enrollee is moving from one MCO, PIHP, PAHP, 
or PCCM to another and that enrollee experiences a serious detriment to 
health or be at risk of hospitalization or institutionalization without 
continued access to services. As states are currently required to 
ensure services for enrollees during plan transitions, they have a 
policy but it may need to be revised to accommodate the requirements 
and to include transitions from FFS. We estimate it will take 42 states 
5 hours at $64.46/hr for a state business operations specialist to 
revise their policies and procedures and 4 hr at $78.32/hr for a 
computer programmer to create a program to compile and send the data. 
In aggregate, we estimate a one-time state burden of 378 hr (42 states 
-9 hr) and $26,694.36 (210 hr (42 x 5) -$64.46/hr + 168 hr (42 x 4) x 
$78.32/hr). We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires. We are not estimating additional burden for the routine 
running of these reports since they will be put into a normal 
production schedule.
    Section 438.62(b)(2) requires that MCOs, PIHPs, PAHPs, and PCCMs 
implement their own transition of care policy that meets the 
requirements of Sec.  438.62(b)(1). Under current requirements and as 
part of usual and customary business practice for all managed care 
plans, the MCOs, PIHPs, PAHPs, or PCCMs already exchange data with each 
other for this purpose. To revise their existing policies to reflect 
the standards in (b)(1), we estimate 1 hr at $64.46 for a business 
operations specialist. To develop computer programs to receive and 
store FFS data, we estimate 4 hr at $78.32/hr for a computer 
programmer. We are not estimating additional burden for the routine 
running of these reports since they will likely be put into a 
production schedule. In aggregate, we estimate a

[[Page 27777]]

one-time private sector burden of 586 hr (335 MCOs + 176 PIHPs + 41 
PAHPs, and 34 PCCMs x 1 hr) and $37,773.56 (586 hr x $64.46/hr) and 
2,344 hr (586 x 4 hr) and $183,582.08 (2,272 hr x $78.32/hr). We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires.
    For transitions, we estimate 10 min (per request) at $66.92/hr for 
a registered nurse to access the stored data and take appropriate 
action. We also estimate that approximately 0.05 percent of 6,274,080 
new enrollees (313,704) may meet the state defined criteria for serious 
detriment to health and/or risk of hospitalization or 
institutionalization. In aggregate, we estimate an annual private 
sector burden of 52,294 hr (313,704 enrollees x 10 min) and 
$3,499,545.05 (52,294 hr x $66.92/hr).
9. ICRs Regarding State Monitoring Procedures (Sec.  438.66)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.66(a) and (b) requires states with MCO, PIHP, PAHP, or 
PCCM programs to have a monitoring system including at least the 13 
areas specified in paragraph (b). While having a monitoring system is a 
usual and customary business process for all of the state Medicaid 
agencies, including all 13 areas will require most states to make at 
least some revisions to their existing processes and policies. We 
estimate 8 hr at $64.46/hr for a business operations specialist to 
expand or revise existing policies and procedures. In aggregate, we 
estimate a one-time state burden of 336 hr (42 states x 8 hr) and 
$21,658.56 (336 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
    Section 438.66(c) requires states with MCO, PIHP, PAHP, or PCCM 
programs to utilize data gathered from its monitoring activities in 12 
required areas to improve the program's performance. While all states 
currently utilize data for program improvement to some degree, 
incorporating all 12 areas will likely require some revisions to 
existing policies and procedures. We estimate a one-time state burden 
of 20 hr at $64.46/hr for a business operations specialist to revise 
existing or to create new policies and procedures for utilizing the 
collected data. In aggregate, we estimate 840 hr (42 states x 20 hr) 
and $54,146.40 (840 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
    Section 438.66(d)(1) through (3) requires that states include a 
desk review of documents and an on-site review for all readiness 
reviews when certain events occur. For preparation and execution of the 
readiness review, we estimate 5 hr (at $140.80/hr) for a general and 
operations manager, 30 hr (at $64.46/hr) for a business operations 
specialist, and 5 hr (at $78.32/hr) for a computer programmer. The time 
and staff types are estimated for a new program or new entity review 
and may vary downward when the review is triggered by one of the other 
events listed in (d)(1). Given the varying likelihood of the 3 events 
listed in (d)(1), we will use an average estimate of 20 states per year 
having one of the triggering events. In aggregate, we estimate an 
annual state burden of 800 hr (20 states x 40 hr) and $60,588 [20 
states x ((5 x $140.80/hr) +(30 x $64.46/hr) + (5 x $78.32/hr))].
    For MCO, PIHP, PAHP, or PCCM preparation and execution, we estimate 
5 hr (at $140.80/hr) for a general and operations manager, 30 hr (at 
$64.46/hr) for a business operations specialist, and 5 hr (at $78.32/
hr) for a computer programmer. In aggregate, we estimate an annual 
private sector burden of 800 hr (20 entities x 40 hr) and $60,588 [20 
entities x ((5 x $140.80/hr) + (30 x $64.46/hr) + (5 x $78.32/hr))].
    Section 438.66(e)(1) and (2) requires that states submit an annual 
program assessment report to CMS covering the topics listed in Sec.  
438.66(e)(2). The data collected for Sec.  438.66(b) and the 
utilization of the data in Sec.  438.66(c) will be used to compile this 
report. We estimate an annual state burden of 6 hr at $64.46/hr for a 
business operations specialist to compile and submit this report to 
CMS. In aggregate, we estimate an annual state burden of 252 hr (42 
states x 6 hr) and $16,243.92 (252 hr x $64.46/hr).
10. ICRs Regarding Network Adequacy (Sec.  438.68)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.68(a) requires that states set network adequacy 
standards that each MCO, PIHP and PAHP must follow. Section 438.68(b) 
and (c) would require that states set standards which must include time 
and distance standards for specific provider types and must develop 
network standards for LTSS if the MCO, PIHP or PAHP has those benefits 
covered through their contract.
    We estimate states will spend 10 hr in the first year developing 
the network adequacy standards for the specific provider types found in 
Sec.  438.68(b)(1). While 40 states have contracted with at least one 
MCO, PIHP or PAHP, we believe that 20 will need to develop the 
standards and 20 already have a network adequacy standard in place. 
After the network standards have been established, we estimate that the 
maintenance of the network standards will occur only periodically as 
needs dictate; therefore, we do not estimate additional burden for 
states after the first year.
    To develop network standards meeting the specific provider types 
found in Sec.  438.68(b)(1), we estimate a one-time state burden of 10 
hr at $64.46/hr for a business operations specialist. In aggregate, we 
estimate 200 hr (20 states x 10 hr) and $12,892 (200 hr x $64.46/hr). 
We are annualizing the one-time development since we do not anticipate 
any additional burden after the 3-year approval period expires.
    To develop LTSS standards, we estimate a one-time state burden of 
10 additional hr at $64.46/hr for a business operations specialist to 
develop those standards. In aggregate, we estimate 160 hr (16 states 
with MLTSS programs x 10 hr) and $10,313.60 (160 hr x $64.46/hr). We 
are annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires.
    Section 438.68(d) requires that states develop an exceptions 
process for use by MCOs, PIHPs, and PAHPs unable to meet the network 
standards established in Sec.  438.68(a). We estimate a one-time state 
burden of 3 hr at $64.46/hr for a business operations specialist to 
design an exceptions process for states to use to evaluate requests 
from MCOs, PIHP, and PAHPs for exceptions to the network standards. 
With a total of 40 states contracting with at least one MCO, PIHP or 
PAHP, we estimate a one-time aggregate state burden of 120 hr (40 
states x 3 hr) and $7,735.20 (120 hr x $64.46). We are annualizing the 
one-time development since we do not anticipate any additional burden 
after the 3-year approval period expires.
    The exception process should not be used very often as MCOs, PIHPs, 
and PAHPs meeting the established standards is critical to enrollee 
access to care. As such, after the exceptions process is established, 
we estimate that the occasional use of it will not generate

[[Page 27778]]

any measurable burden after the first year.
    States' review and reporting on exceptions granted through the 
process developed in Sec.  438.68(d) is estimated under Sec.  438.66 so 
we do not estimate any additional burden for this requirement.
11. ICRs Regarding Stakeholder Engagement When LTSS Is Delivered 
Through a Managed Care Program (Sec.  438.70)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.70(c) requires that states continue to solicit and 
address public input for oversight purposes. Existing MLTSS programs 
already meet this requirement and we estimate no more than 14 new 
programs will be established by states.
    We estimate an annual state burden of 4 hr at $64.46/hr for a 
business operations specialist to perform this task. In aggregate, we 
estimate 56 hr (14 states x 4 hr) and $3,609.76 (152 hr x $64.46/hr).
12. ICRs Regarding Beneficiary Support System (Sec.  438.71)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with revision and minor adjustments 
to hourly rates. Two comments were received.
    Section 438.71(a) requires that state develop and implement a 
system for support to beneficiaries before and after enrollment in a 
MCO, PIHP, PAHP, or PCCM. This will most likely be accomplished via a 
call center including staff having email capability--internal to the 
state or subcontracted--that will assist beneficiaries with questions. 
As most state Medicaid programs already provide this service, we 
estimate only 20 states may need to take action to address this 
requirement.
    A state has multiple ways to implement this provision; it could 
procure a vendor for this function, amend an existing contract (for 
example, enrollment broker), or add staff or train existing internal 
call center, outreach, or ombudsman staff. We offer a burden here for 
procuring a new contractor or establishing a new call center, although 
we do not believe these are the options that most states will elect. We 
include a 150 hour burden here as an average for the more costly 
options available to states- procuring a new vendor or creating a call 
center. The one-time state burden would consist of 125 hr (at $64.46/
hr) for a business operations specialist, and 25 hr (at $140.80/hr) for 
a general and operations manager. In aggregate, we estimate 3,000 hr 
(20 states x 150 hr) and $231,550 [20 states x ((125 hr x $64.46/hr) + 
(25 hr x $140.80/hr))]. We acknowledge that there may be on-going 
burden associated with this provision; however, given the multiple 
options for implementing it, we are unable to estimate that burden at 
this time.
    Section 438.71(b) requires that the system include choice 
counseling for enrollees, outreach for enrollees, and education and 
problem resolution for services, coverage, and access to LTSS. This 
system must be accessible in multiple ways including at a minimum, by 
telephone and email. Some in-person assistance may need to be provided 
in certain circumstances. Most states will likely use the call center 
created in Sec.  438.71(a) to handle the majority of these 
responsibilities and use existing community-based outreach/education 
and ombudsman staff, whether state employees or contractors, for the 
occasional in person request. The use of existing staff will add no 
additional burden as it is part of standard operating costs for 
operating a Medicaid program.
    In Sec.  438.71(d), our proposed rule had set out requirements and 
burden which would have required that states develop training materials 
for provider education on MLTSS. That requirement is not being 
finalized, as discussed in I.B.5.c.
    We received the following comments:
    Comment: We received a few comments expressing concern that the 
beneficiary support systems will not be funded adequately to be 
effective. CMS estimates one-time expenditures of 150 hours to create a 
call center and 3 hours to create provider education materials, plus 
one hour annually for those same materials (see 80 FR at 31182). The 
commenters disagreed that states would use call centers and existing 
ombudsman program and, therefore, would incur more expense than 
estimated. Commenters believed that an effective beneficiary support 
network would require time and resources that far exceed the current 
estimates.
    Response: We are unclear why the commenters believe our estimates 
are low. Many states already have call centers and/or use enrollment 
brokers to perform many of the functions proposed in Sec.  438.71. 
While some states may need to amend their existing contracts or provide 
additional staff training, we believe that most already have the 
foundation for the beneficiary support system between existing state, 
contractual, and ombudsman resources.
    Comment: One commenter believed that CMS vastly underestimated the 
amount of time it takes to develop training and education materials and 
to keep those materials updated for the proposed provisions in Sec.  
438.71(b)(1)(ii) and (d) in a continuously changing health care 
environment.
    Response: Based on comments received to proposed provisions in 
Sec.  438.71(b)(1)(ii) and (d), we will not be finalizing those 
paragraphs. See section I.B.5.c. for additional detail.
13. ICRs Regarding Member Advisory Committee (Sec.  438.110)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.110(a) requires that each MCO, PIHP, and PAHP establish 
and maintain a member advisory board if the LTSS population is covered 
under the contract. We estimate an annual private sector burden of 6 hr 
at $64.46/hr for a business operations specialist to maintain the 
operation of the committee (hold meetings, distribute materials to 
members, and maintain minutes) for up to 14 new programs. Existing 
programs already meet this requirement and we estimate no more than 14 
new programs will be established by states. In aggregate, we estimate 
84 hr (14 states x 6 hr) and $5,414.64 (84hr x $64.46/hr).
14. ICRs Regarding Assurances of Adequate Capacity and Services (Sec.  
438.207)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.207(c) requires that the documentation required in 
Sec.  438.207(b) be submitted to the state at least annually. As the 
MCOs, PIHPs, and PAHPs will already run and review these reports 
periodically to monitor their networks as part of normal network 
management functions and as part of the provisions of Sec.  438.68, the 
only additional burden would possibly be (if the state doesn't already 
require this at least annually) for the MCOs, PIHPs, and PAHPs to 
revise their policy to reflect an annual submission. We estimate a one-
time private sector burden of 1 hr at $64.46/hr for a business 
operations specialist to revise the policy, if needed. We are 
annualizing the one-time development

[[Page 27779]]

since we do not anticipate any additional burden after the 3-year 
approval period expires.
    In aggregate, we estimate 552 hr (335 MCOs + 176 PIHPs + 41 PAHPs x 
1 hr) and $35,581.92 (552 hr x $64.46/hr) for policy revision. We also 
estimate an annual private sector burden of 2 hr to compile and submit 
the information necessary to meet the requirements in Sec.  438.207(b) 
through (d). For compilation and submission, we estimate 1,104 hr (335 
MCOs + 176 PIHPs + 41 PAHPs x 2 hr) and $71,163.84 (1,104 hr x $64.46/
hr).
15. ICRs Regarding Coordination and Continuity of Care (Sec.  438.208)
    While one PRA-related public comment was received with regard to 
our proposed requirements and burden estimates, we have considered the 
comment and are adopting the proposed provisions/estimates without 
change. See below for our finalized provisions/estimates along with a 
summary of the comment and our response.
    Section 438.208(b)(2)(iii) requires that MCOs, PIHPs and PAHPs 
coordinate service delivery with the services the enrollee receives in 
the FFS program (carved out services). This involves using data from 
the state to perform the needed coordination activities. The exchange 
of data and the reports needed to perform the coordination activity is 
addressed in the requirements in Sec.  438.62(b)(2). Since only a small 
percentage of enrollees receive carved out services and need assistance 
with coordination, we estimate 5 percent of all MCO, PIHP, and PAHP 
enrollees (2,331,626 of 46,632,522 MCO, PIHP, and PAHP enrollees) will 
be affected. We estimate an ongoing private sector burden of 10 min 
(per enrollee) at $51.54/hr for a healthcare social worker to perform 
the care coordination activities. In aggregate, we estimate 457,838 hr 
(2,331,626 enrollees x 10 min) and $23,596,970.52 (457,746 hr x $51.54/
hr).
    Section 438.208(b)(3) requires that a MCO, PIHP or PAHP make its 
best effort to conduct an initial assessment of each new enrollee's 
needs within 90 days of the enrollment. We believe that most MCOs and 
PIHPs already meet this requirement and only 25 percent of the MCOs and 
PIHPs (84 MCOs + 44 PIHPs) will need to alter their processes; however, 
we do not believe this to be as common a practice among PAHPs and 
assume that all 41 non-NEMT PAHPs will need to add this assessment to 
their initial enrollment functions. We estimate a one-time private 
sector burden of 3 hr at $64.46/hr for a business operations specialist 
to revise their policies and procedures. In aggregate, we estimate 507 
hr [(84 MCOs + 44 PIHPs + 41 PAHPs) x 3 hr] and $32,681.22 (507 hr x 
$64.46/hr). While PRA-related public comments were received with regard 
to our proposed requirements and burden estimates, we have considered 
the comments and are adopting the proposed provisions/estimates without 
change. See below for our finalized provisions/estimates along with a 
summary of the comments and our response.
    We estimate that in a given year, only 5 percent (726,143) of 25 
percent of MCO and PIHP (10,703,220) and all (3,819,643 non-NEMT) PAHP 
enrollees are new to a managed care plan. We estimate an annual private 
sector burden of 10 min (on average) at $35.86/hr for a customer 
service representative to complete the screening. In aggregate, we 
estimate 121,023 hr (726,143 enrollees x 10 min) and $4,320,550 
(121,023 hr x $35.86/hr).
    Section 438.208(b)(4) requires that MCOs, PIHPs, and PAHPs share 
with other MCOs, PIHPs, and PAHPs serving the enrollee the results of 
its identification and assessment of any enrollee with special health 
care needs so that those activities are not duplicated. The burden 
associated with this requirement is the time it takes each MCO, PIHP or 
PAHP to disclose information on new enrollees to the MCO, PIHP or PAHP 
providing a carved out service. This would most likely be accomplished 
by developing a report to collect the data and electronically posting 
the completed report for the other MCO, PIHP, or PAHP to retrieve.
    We estimate a one-time burden of 4 hr at $78.32/hr for a computer 
programmer to develop the report. In aggregate, we estimate 2,272 hr 
(335 MCOs + 176 PIHPs + 41 PAHPs x 4 hr) and $177,943.04 (2,272 hr x 
$78.32/hr). However, while the currently approved burden sets out 45 
min per enrollee and 464,782 annual hours, to provide more accurate 
estimates we are adjusting the burden by using one-time per plan 
estimates and recognizing the use of automated reporting. In aggregate, 
we estimate a one-time private sector burden of -462,510 hr (2,272 hr - 
464,782 hr) and -$36,223,783.20 (-462,510 hr x $78.32/hr). While a PRA-
related public comment was received with regard to our proposed 
requirements and burden estimates, we have considered the comments and 
are adopting the proposed provisions/estimates without change. See 
below for our finalized provisions/estimates along with a summary of 
the comments and our response. Once put on a production schedule, no 
additional staff time will be needed, thus no additional burden is 
estimated.
    Section 438.208(c)(2) and (3) currently require that MCOs, PIHPs 
and PAHPs complete an assessment and treatment plan for all enrollees 
that have special health care needs; this rule adds ``enrollees who 
require LTSS'' to this section. These assessments and treatment plans 
should be performed by providers or MCO, PIHP or PAHP staff that meet 
the qualifications required by the state. We believe the burden 
associated with this requirement is the time it takes to gather the 
information during the assessment. (Treatment plans are generally 
developed while the assessment occurs so we are not estimating any 
additional time beyond the time of the assessment.) We believe that 
only enrollees in MCOs and PIHPs will require this level of assessment 
as most PAHPs provide limited benefit packages that do not typically 
warrant a separate treatment plan.
    While this is an existing requirement, we estimate an additional 1 
percent of the total enrollment of 42,812,879 in MCOs and PIHPs 
(42,812,879 x .01 = 428,128) given the surge in enrollment into managed 
care of enrollees utilizing LTSS. We estimate an annual private sector 
burden of 1 hr (on average) at $66.92/hr for a registered nurse to 
complete the assessment and treatment planning. In aggregate, we 
estimate an additional 428,128 hr (428,128 enrollees x 1 hr) and 
$28,650,325.76 (428,128 hr x $66.92/hr).
    Section 438.208(c)(3)(v) requires that treatment plans be updated 
at least annually or upon request. We estimate a one-time private 
sector burden of 1 hr at $64.46/hr for a business operations specialist 
to revise policies and procedures to reflect a compliant time frame. In 
aggregate, we estimate 552 hr (335 MCOs + 176 PIHPs + 41 PAHPs x 1 hr) 
and $35,581.92 (552 hr x $64.46/hr).
    We received the following comment:
    Comment: One commenter believed the COI estimate for proposed Sec.  
438.208(b)(2) of 10 minutes at a social worker's rate is low and should 
be 20-30 minutes at a nurse's rate.
    Response: We disagree with the commenter that the burden estimate 
is low. There is great variation in the processes used by states and 
managed care plans to accommodate transition periods. Many provide a 
period of time for all new enrollees to maintain existing provider 
relationships while locating a participating provider. Many also give 
automatic transition periods based on the enrollee's course of 
treatment. For example, many managed care plans automatically authorize

[[Page 27780]]

pregnant women to remain with their existing provider through their 
postpartum visit. These types of mechanisms reduce the average amount 
of time and the type of managed care plan staff needed per enrollee. As 
such, we believe our estimate is a reasonably representative average. 
We decline to revise our estimate.
16. ICRs Regarding Coverage and Authorization of Services (Sec.  
438.210)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.210(a)(4)(ii)(B) requires that MCOs, PIHPs, and PAHPs 
authorize services for enrollees with chronic conditions or receiving 
LTSS in a way that reflects the on-going nature of the service. While 
we expect this to already be occurring, we also expect that most MCOs, 
PIHPs, and PAHPs will review their policies and procedures to ensure 
compliance. We estimate a one-time private sector burden of 20 hr at 
$66.92/hr for a registered nurse to review and revise, if necessary, 
authorization policies and procedures. In aggregate, we estimate 11,440 
hr (335 MCOs + 176 PIHPs + 61 PAHPs x 20 hr) and $765,564.80 (11,440 x 
$66.92/hr). We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires.
    Section 438.210(c) currently requires that each contract provide 
for the MCO or PIHP to notify the requesting provider of a service 
authorization request denial, and give the enrollee written notice of 
any decision by the MCO, PIHP, or PAHP to deny a service authorization 
request, or to authorize a service in an amount, duration, or scope 
that is less than requested. In this final rule, PAHPs are be added to 
this requirement.
    The burden associated with sending adverse benefit determination 
notices is included in Sec.  438.404. While we believe PAHPs already 
provide notification of denials, we expect they may need to be revised 
to be compliant with Sec.  438.404. We estimate a one-time public 
sector burden of 1 hr at $64.46/hr for a business operations specialist 
to revise the template. In aggregate, we estimate 61 hr (61 PAHPs x 1 
hr) and $3,932.06 (61 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
17. ICRs Regarding Subcontractual Relationships and Delegation (Sec.  
438.230)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change, except for the 
minor adjustments to hourly rates. No comments were received.
    Section 438.230 would require additional provisions in MCO, PIHP, 
or PAHP subcontracts, other than agreements with network providers. We 
estimate a one-time private sector burden of 3 hr at $64.46/hr for a 
business operations analyst to amend appropriate contracts. In 
aggregate, we estimate 1,716 hr (335 MCO + 176 PIHPs + 61 PAHPs x 3 hr) 
and $110,613.36 (1,716 x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
18. ICRs Regarding Health Information Systems (Sec.  438.242)
    While one PRA-related public comment was received with regard to 
our proposed requirements and burden estimates, we have considered the 
comment and are adopting the proposed provisions/estimates without 
change. See below for our finalized provisions/estimates along with a 
summary of the comment and our response.
    Section 438.242(b) and (c) currently requires MCOs and PIHPs to 
collect and submit to the state enrollee encounter data. This rule adds 
non-NEMT PAHPs to the requirement. We estimate a one-time private 
sector burden of 20 hr at $78.32/hr for a computer programmer to 
extract this data from a PAHP's system and report it to the state. In 
aggregate, we estimate 820 hr (41 PAHPs x 20 hr) and $64,222.40 (820 hr 
x $78.32/hr). After creation, these reports would be set to run and 
sent to the state at on a production schedule. We are annualizing the 
one-time development since we do not anticipate any additional burden 
after the 3-year approval period expires.
    We received the following comment on this collection of information 
estimate:
    Comment: We received one comment on the COI burden estimate in 
Sec.  438.242: ``MCOs collect and submit to the state enrollee 
encounter data. 820 hr (41 PAHPs x 20 hr) and $60,352 (820 hr x $73.60/
hr).'' The commenter believed CMS is drastically under valuing the time 
and expense it takes to build this capability within complex systems.
    Response: We disagree that the estimated hours undervalue the time 
necessary given that the majority of encounter data is sent to a 
managed care plan in a standardized format (most often the ASC X12N 
837) which is also the format that Sec.  438.242 requires that the 
managed care plan utilize when submitting the same data to the state. 
The use of standardized formats was included in Sec.  438.242 to, among 
other reasons, minimize the amount of programming time and 
customization needed and permit managed care plans to maximize the 
efficiencies of submitting encounter data in the same format in which 
it receives most claim data. Additionally, Sec.  438.242 has required 
managed care plans to submit encounter data to the state since part 438 
was finalized in 2002; we do not believe the changes proposed here will 
require managed care plans in most states to make an unreasonable 
amount of programming changes. We decline to revise this estimate.
19. ICRs Regarding Basis, Scope, and Applicability (Sec.  438.310)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.310(c)(2) applies Sec.  438.330(b)(2), (b)(3), (c), and 
(e), Sec.  438.340(e) and Sec.  438.350 to states whose contracts with 
PCCM entities include shared savings, incentive payments, or other 
financial reward for the PCCM entity for improved quality outcomes. 
This will affect a specific subset of approximately 9 PCCM entities and 
5 states.
    We estimate a one-time state burden of 2 hr at $64.46/hr for a 
business operations specialist to address the performance assessment of 
PCCM entities described in Sec.  438.310(c)(2) by revising a state's 
policies and procedures. We are annualizing the one-time development 
since we do not anticipate any additional burden after the 3-year 
approval period expires. In aggregate, we estimate 10 hr (5 states x 2 
hr) and $644.60 (10 hr x $64.46/hr), annualized to 3.3 hr and $214.87.
    20. ICRs Regarding Quality Assessment and Performance Improvement 
Program (Sec.  438.330, formerly Sec.  438.240)
    While one PRA-related public comment was received with regard to 
our proposed requirements and burden estimates for this section, we 
have considered the comment and are adopting the proposed provisions/
estimates without change except for the minor adjustments to hourly 
rates. See below for our finalized provisions/

[[Page 27781]]

estimates along with a summary of the comments and our response.
    Section 438.330(a)(2) specifies the process CMS will use if it 
elects to specify a common set of national QAPI performance measures 
and PIP topics, which will include a public notice and comment process. 
Assuming that we do use this process to identify QAPI performance 
measures and PIP topics at least once every 3 years, the burden for 
states will be altered. Some may experience a decrease in the time 
spent selecting performance measures and PIP topics while others might 
experience a slight increase in the form of programming their MMIS 
systems to account for the specified performance measures and PIP 
topics.
    We estimate a state burden of 10 hr (every 3 years) at $78.32/hr 
for a computer programmer to make the MMIS programming changes. In 
aggregate, we estimate an annualized burden of 133.3 hr [(40 states x 
10 hr)/3 years] and $10,440.06 (133.3 hr x $78.32/hr). We cannot 
estimate the amount of possible decrease in burden as we have no way to 
know the average amount of time a state expended on selecting 
performance measures or PIP topics and how this might change based on 
this revision.
    Section 438.330(a)(2) also will allow states to apply for an 
exemption from the CMS-specified QAPI performance measures and PIP 
topics established under Sec.  438.330(a)(2). While we have no data on 
how many states will take advantage of this option, given that the 
performance measures and PIP topics under Sec.  438.330(a)(2) will be 
identified through a public notice and comment process, we estimate 
that approximately 11 states will ask for an exemption every 3 years. 
We estimate a state burden of 1 hr (every 3 years) at $64.46/hr for a 
business operations specialist to comply with the exemption process. In 
aggregate, we estimate an annualized burden of 3.7 hr [(11 states x 1 
hr)/3 years] and $238.50 (3.7 hr x $64.46/hr).
    Proposed Sec.  438.330(a)(2)(ii) would allow states to select 
performance measures and PIPs in addition to those specified by CMS 
under Sec.  438.330(a)(2)). Since this requirement exists under Sec.  
438.330(c) of the final rule, we are not finalizing proposed Sec.  
438.330(a)(2)(ii). This has no impact on the burden as compared to the 
proposed rule.
    Section 438.330(a)(3) identifies the regulatory components of Sec.  
438.330 that apply to the QAPI of a PCCM entity described in Sec.  
438.310(c)(2). The burden associated with these regulatory components 
in regards to PCCM entities in Sec. Sec.  438.330(b)(3), (c), and (e) 
is described below.
    Section 438.330(b)(3) clarifies that MCOs, PIHPs, and PAHPs will 
have an approach to evaluate and address findings regarding the 
underutilization and overutilization of services. Because utilization 
review in managed care has become commonplace in the private, Medicare, 
and Medicaid settings, we do not believe that this regulatory provision 
imposes any new burden on MCOs, PIHPs, or PAHPs. However, in accordance 
with Sec.  438.310(c)(2), PCCM entities (we estimate there are 9 total) 
will now be subject to this operational component.
    We recognize that PCCM entities may not currently have in place 
mechanisms to assess and address underutilization and overutilization 
of services in accordance with Sec.  438.330(b)(3). We estimate a one-
time private sector burden of 10 hr at $64.46/hr for a business 
operations specialist to establish the policies and procedures. We are 
annualizing the one-time development burden since we do not anticipate 
any additional development burden after the 3-year approval period 
expires. In aggregate, we estimate 90 hr (9 PCCM entities x 10 hr) and 
$5,801.4 (90 hr x $64.46/hr), annualized to 30 hr and $1933.8, for the 
establishment of policies and procedures. We also estimate an ongoing 
annual burden of 10 hr to evaluate and address the findings. In 
aggregate, we estimate 90 hr (9 PCCM entities x 10 hr) and $5801.4 (90 
hr x $64.46/hr) for program maintenance.
    Section 438.330(c) addresses QAPI performance measurement. Section 
438.330(c)(1) requires that the state identify standard performance 
measures for their managed care plans, including LTSS measures if 
appropriate. These must include any performance measures specified by 
CMS under Sec.  438.330(a)(2). We believe that it is standard practice 
for states to identify performance measures for their contracted 
managed care plans; therefore there is no burden associated with this 
paragraph.
    Section 438.330(c)(2) requires each MCO, PIHP, PAHP, and PCCM 
entity (described in Sec.  438.310(c)(2)) to annually measure its 
performance using the standard measures specified by the state in Sec.  
438.330(c)(1) and to report on its performance to the state. We assume 
that each of the 335 MCOs and 176 PIHPs will report on three 
performance measures to the state. The use of performance measures is 
commonplace in private, Medicare, and Medicaid managed care markets; 
therefore we believe that MCOs and PIHPs already collect performance 
measures.
    For MCOs (335) and PIHPs (176), we estimate an annual private 
sector burden of 0.1 hr at $64.46/hr for a business operations 
specialist to report on a single performance measure to the state. In 
aggregate, we estimate 153.3 hr (511 MCOs and PIHPs x 3 performance 
measures x 0.1 hr) and $9,881.72 (153.3 hr x $64.46/hr).
    We recognize that PAHPs and PCCM entities (described in Sec.  
438.310(c)(2)) may not currently engage in performance measurement as 
described in Sec.  438.330(c)(2). We estimate that each PCCM entity and 
each PAHP will report to the state on 3 performance measures annually. 
For the 41 PAHPs and 9 PCCM entities, we estimate an annual private 
sector burden of 4 hr (per measure) at $64.46/hr for a business 
operations specialist to collect, calculate, and submit each 
performance measure to the state. In aggregate, we estimate 600 hr (51 
PAHPs and PCCMs x 3 performance measures x 4 hr) and $38,676 (600 hr x 
$64.46/hr).
    Section 438.330(c)(2) also requires each MCO, PIHP, PAHP, and PCCM 
entity (described in Sec.  438.310(c)(2)) providing LTSS to annually 
measure its performance using the standard measures specified by the 
state in Sec.  438.330(c)(1)(ii) and to report on its performance to 
the state. Section 438.330(c)(1)(ii) requires states to identify 
standard performance measures in two LTSS-specific categories for 
managed care plans that provide LTSS. Assuming that each of the 179 
MLTSS plans will report on at least one measure per category and a 
burden of 4 hr (per measure) at $64.46/hr for a business operations 
specialist to collect, calculate, and submit each LTSS performance 
measure to the state, we estimate an aggregated annual private sector 
burden of 1,432 hr (179 MLTSS plans x 2 performance measures x 4 hr) 
and $92,306.72 (1,432 hr x $64.46/hr).
    Under Sec.  438.330(d)(1) through (3), states must ensure that each 
MCO, PIHP, and PAHP has an ongoing program of PIPs, designed to achieve 
sustainable improvement, which the managed care plan will report on to 
the state as requested, but at least once per year. We assume that each 
MCO and PIHP will conduct at least 3 PIPs in any given year. We further 
expect that states would request the status and results of each 
entity's PIPs annually. The currently approved burden under this 
control number estimates that each of the 539 MCOs and PIHPs conducts 3 
PIPs, for a burden of 12,936 hr (539 MCOs and PIHPs x 3 PIPs x 8 hr). 
However, this figure overestimates the number of MCOs and PIHPs. 
Therefore, we estimate an annual private sector burden of 8 hr at 
$64.46/hr for a business operations specialist to report

[[Page 27782]]

on each PIP. In aggregate, we estimate 12,264 hr (511 MCOs and PIHPs x 
8 hr x 3 PIPs) and $790,537.44 (12,264 hr x $64.46/hr).
    We assume that each PAHP will conduct at least one PIP each year, 
and that states will request the status and results of each PAHP's PIP 
annually. We estimate a one-time private sector burden of 2 hr at 
$64.46/hr for a business operations specialist to develop policies and 
procedures. We are annualizing the one-time development burden since we 
do not anticipate any additional burden after the 3-year approval 
period expires. In aggregate, we estimate 82 hr (41 PAHPs x 2 hr) and 
$5,285.72 (82 hr x $64.46/hr), annualized to 27.3 hr and $1,761.91. We 
also estimate an annual private sector burden of 8 hr to prepare a PIP 
report. In aggregate, we estimate 328 hr (41 PAHPs x 1 PIP x 8 hr) and 
$21,142.88 (328 hr x $64.46/hr).
    Section 438.330(e)(1) requires the state to review the impact and 
effectiveness of each MCO's, PIHPs, and PAHP's QAPI at least annually. 
States must also review the QAPI of each PCCM entity (described in 
Sec.  438.310(c)(2)). We estimate an annual state burden of 15 hr at 
$64.46/hr for a business operations specialist to assess the 
performance of a single PCCM entity (described in Sec.  438.310(c)(2)). 
In aggregate, we estimate 135 hours (9 PCCM entities x 15 hr) and 
$8702.1 (135 hr x $64.46/hr).
    Under section 438.330(e)(1)(ii), states will include outcomes and 
trended results of each MCO, PIHP, and PAHP's PIPs in the state's 
annual review of QAPI programs. We estimate a one-time state burden of 
0.5 hr at $64.46/hr for a business operations specialist to modify 
policies and procedures for the 40 states with MCOs, PIHPs and PAHPs. 
We are annualizing the one-time development since we do not anticipate 
any additional burden after the 3-year approval period expires. In 
aggregate, we estimate 20 hr (40 states x 0.5 hr) and $1,289.20 (20 hr 
x $64.46/hr), annualized to 6.7 hr and $429.73. We also estimate an 
annual state burden of 1 hr to conduct the additional annual review of 
the outcomes and trended results for each of the 552 MCOs, PIHPs, and 
PAHPs (335 MCOs, 176 PIHPs, 41 PAHPs). In aggregate, we estimate 552 hr 
(552 MCOs, PIHPs, and PAHPs x 1 hr) and $35,581.92 (552 hr x $64.46/
hr).
    Section 438.330(e)(1)(iii) is a new program component, related to 
Sec.  438.330(b)(5), which will require a state (in its annual review) 
to assess the results of any efforts to support state goals to promote 
community integration of beneficiaries using LTSS in place at the MCO, 
PIHP, or PAHP. We estimate that the 16 states with MLTSS plans will 
need to modify their policies and procedures regarding the annual 
review of QAPI programs in their managed care entities. We estimate a 
one-time state burden of 0.5 hr at $64.46/hr for a business operations 
specialist to modify the state's policies and procedures. We are 
annualizing the one-time development burden since we do not anticipate 
any additional burden after the 3-year approval period expires. In 
aggregate, we estimate 8 hr (16 states x 0.5 hr) and $515.68 (8 hr x 
$64.46/hr), annualized to 2.7 hr and $171.89. We also estimate an 
annual burden of 1 hr for the assessment of rebalancing efforts of each 
of the 179 MLTSS plans. In aggregate, we estimate 179 hr (179 MLTSS 
plans x 1 hr) and $11,538.34 (179 hr x $64.46/hr) for the assessment.
    We received the following comments regarding the proposed ICRs 
regarding QAPI program:
    Comment: One commenter noted that the proposed changes to QAPI 
(along with the proposed changes to EQR and the proposed CQS) drove the 
new burden associated with the proposed quality revisions. The 
commenter believed that the cost estimates for these changes seemed 
understated, and that state might not be able to successfully bear this 
burden without consideration of a temporary enhanced match or other 
funding.
    Response: While the commenter believed that the QAPI estimates were 
understated, it is not clear to us in what respect that is the case. We 
developed the estimates for QAPI based off of established estimates for 
MCOs and PIHPs for this topic. We note that these are estimates, and 
actual states practices and implementation may cause actual experience 
to be more, less, or the same as these estimates. Without clearer 
direction as to where our estimate is lacking, we decline to revise the 
QAPI burden estimates.
21. ICRs Regarding State Review of the Accreditation Status of MCOs, 
PIHPs, and PAHPs (Sec.  438.332)
    Under Sec.  438.332 of the proposed rule, titled ``State Review and 
Approval of MCOs, PIHPs, and PAHPs,'' we proposed that states would 
review and approve MCO, PIHP, and PAHP performance, at least once every 
3 years, in accordance with standards at least as strict as those used 
by a private accrediting entity that is approved or recognized by CMS 
under the existing Marketplace and MA programs, as a condition of 
contracting with the state. We also proposed to grant states the option 
of allowing MCOs, PIHPs, and PAHPs to meet this standard by presenting 
proof of accreditation by a private accrediting entity recognized by 
CMS. MCOs, PIHPs, and PAHPs would have been required to maintain state 
approval for the duration of participation in the Medicaid program. 
State approval of MCOs, PIHPs, and PAHPs would have been renewed every 
3 years.
    As discussed in section I.B.6.b(2)(e) of this rule, in response to 
public comments also discussed in that section, we are not finalizing 
our proposal to require states to review and approve MCO, PIHP, and 
PAHP performance; instead, we are finalizing Sec.  438.332 with 
modification to require states to confirm the accreditation status 
(accredited or not) of each contracted MCO, PIHP, and PAHP annually. As 
a part of this revision, we are finalizing proposed Sec.  438.332(c), 
with modification, to require this information to be posted online each 
year. Therefore we are deleting the burden estimate associated with 
proposed Sec. Sec.  438.332(a) and (b) and replacing it with the burden 
associated with states annually confirming the accreditation status of 
contract MCOs, PIHPs, and PAHPs and posting this information online.
    Under Sec.  438.332(a), states must confirm the accreditation 
status of contracted MCOs, PIHPs, and PAHPs once a year. We estimate an 
annual state burden of 0.25 hr at $64.46/hr for a business operations 
specialist to review the accreditation status of each of the estimated 
552 MCOs, PIHPs, and PAHPs. In aggregate, we estimate an annual burden 
of 138 hr (0.25 hr x 552 MCOs, PIHPs, and PAHPs) and $8,895.48 (138 hr 
x $64.46/hr).
    Section 438.332(b) describes the information MCOs, PIHPs, and PAHPs 
must authorize the private accrediting entity to release to the state 
regarding the plan's accreditation status. We believe that states will 
need to amend their MCO, PIHP, and PAHP contracts to reflect this 
requirement, and estimate a one-time burden of 0.25 hr per contract 
amendment. We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires. In aggregate, we estimate a one-time burden of 138 hr (0.25 hr 
x 552 MCOs, PIHPs, and PAHPs) and $8,895.48 (138 hr x $64.46/hr), 
annualized to 46 hr and $2,965.16.
    Under Sec.  438.332(c), states will document the accreditation 
status of each contracted MCO, PIHP, and PAHP on the state's Web site, 
and will update this information at least annually. The burden is 
included in Sec.  438.10.

[[Page 27783]]

22. ICRs Regarding Medicaid Managed Care Quality Rating System (Sec.  
438.334)
    We received comments that expressed concern that we had 
underestimated the burden associated with the proposed MMC QRS. While 
no specific alternative estimates were provided, we increased the hour 
estimates associated with this ICR to respond to commenters' concerns. 
We have also made minor adjustments to hourly rates. Additional detail 
about this comment and our response may be found at the end of this 
section.
    We received a number of comments on the MMC QRS proposal. In 
response to these comments, and to improve clarity, we restructured 
this section. Under the final rule, Sec.  438.334(a) provides the 
general rule that states must operate a MMC QRS, as did proposed Sec.  
438.334(a)(1). Section 438.334(b) of the final rule describes the CMS-
developed MMC QRS, which was previously described in proposed Sec.  
438.334(a)(2) and (3). Section 438.334(c) of the final rule describes 
the option for states to operate, contingent on CMS approval, an 
alternative MMC QRS, which was described in Sec.  438.334(c) of the 
proposed rule. In the final rule, Sec.  438.334(c) provides additional 
detail regarding the public engagement process required for an 
alternative MMC QRS. The requirement for states to collect data from 
MCOs, PIHPs, and PAHPs each year and to use that data to generate a 
quality rating for the plan is finalized at Sec.  438.334(d), and was 
proposed at Sec.  438.334(b). Finally, Sec.  438.334(e) of the final 
rule, as in the proposed rule, requires states to post the quality 
ratings online. In response to public comments regarding proposed Sec.  
438.334(d), we are not finalizing our proposal to allow states to elect 
to utilize the MA Five-Star rating for MCOs, PIHPs, or PAHPs and 
therefore are deleting the burden associated with that proposal. See 
section I.B.6.b(2)(e) for additional discussion of this restructuring 
and other revisions made in response to public comments.
    Section 438.334(a) requires each state that contracts with an MCO, 
PIHP or PAHP to adopt a MMC QRS to generate plan ratings annually. 
States must either adopt the quality rating system developed by CMS in 
accordance with Sec.  438.334(b) or an alternative MMC QRS in 
accordance with Sec.  438.334(c). We assume each state will create a 
single MMC QRS for all of the state's contracted MCOs, PIHPs, and 
PAHPs. We are aware of 8 states that currently operate a quality rating 
system or quality report card for the state's Medicaid managed care 
program; we assume that these states may want to continue to use their 
existing system given the investments already made in these systems. We 
also assume that a couple of states may determine that a state-specific 
approach is most suitable for them. Therefore, we estimate that of the 
40 states that contract with MCOs, PIHPs, and PAHPs, 30 states will 
elect to adopt the MMC QRS developed by CMS in accordance with Sec.  
438.334(b), while the reminder (10 states) will elect to utilize an 
alternative MMC QRS in accordance with Sec.  438.334(c). We further 
estimate that 75 percent (414) of MCOs, PIHPs, and PAHPs operate in 
these 30 states. We assume that, given the robust public engagement 
process CMS will use to develop the MMC QRS in accordance with Sec.  
438.334(b), states electing to adopt the CMS-developed MMC QRS will not 
need to conduct additional public engagement and will require less time 
to develop their MMC QRS as compared to states which elect to adopt an 
alternative MMC QRS consistent with Sec.  438.334(c).
    Therefore, for states adopting the CMS-developed MMC QRS under 
Sec.  438.334(b), we estimate the state burden for the development and 
implementation of the MMC QRS as 200 hr at $64.46/hr for a business 
operations specialist, 100 hr at $78.32/hr for a computer programmer, 
and 30 hr at $140.80/hr for a general and operations manager. We are 
annualizing the one-time development burden since we do not anticipate 
any additional burden after the 3-year approval period expires. In 
aggregate, we estimate a one-time state burden of 9,900 hr (30 states x 
330 hr) and $748,440 [30 states x ((200 hr x $64.46/hr) + (100 hr x 
$78.32/hr) + (30 hr x $140.80/hr)], annualized to 3,300 hr and 
$249,480, for the development of states' MMC QRS consistent with 
438.334(b).
    The burden is more variable for states seeking CMS approval for the 
adoption of an alternative MMC QRS per Sec.  438.334(c). A state may 
submit an existing MMC QRS, may submit a modified version of an 
existing MMC QRS, or may develop a new MMC QRS. We assume that the 
burden for each of these options will vary by state and will be lowest 
for states that submit an existing MMC QRS for CMS approval and highest 
for states that develop a new MMC QRS. For the purposes of this 
estimate, we assume a standard burden across all states for the 
development of an alternative MMC QRS. We believe that the average 
alternative MMC QRS burden will exceed the burden to adopt the CMS-
developed MMC QRS, and will require public engagement by the state. 
Therefore, we estimate the average state burden for the development and 
implementation of an alternative MMC QRS as 800 hr at $64.46/hr for a 
business operations specialist, 400 hr at $78.32/hr for a computer 
programmer, and 120 hr at $140.80/hr for a general and operations 
manager. We estimate an additional 20 hr at $36.54/hr for an office and 
administrative support worker for the public engagement process and an 
additional 50 hr at $64.46/hr for a business operations specialist to 
review and incorporate public feedback. We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires. In aggregate, we estimate a one-time 
state burden of 13,900 hr (10 states x 1,390 hr) and $1,037,458 [10 
states x ((800 hr x $64.46/hr) + (400 hr x $78.32/hr) + (120 hr x 
$140.80/hr) + (20 hr x $36.54/hr) + (50 hr x $64.46/hr))], annualized 
to 4,633.3 hr and $345,819.33, for the development of states' 
alternative MMC QRS consistent with Sec.  438.334(c).
    To elect the option under Sec.  438.334(c) to use an alternative 
MMC QRS, a state will submit a request to CMS and must receive written 
CMS approval. We estimate a one-time state burden of 20 hr at $64.46/hr 
for a business operations specialist to seek and receive approval from 
CMS for the state's Medicaid managed care alternative quality rating 
system. We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires. In aggregate, we estimate 200 hr (10 states x 20 hr) and 
$12,892 (200 hr x $64.46/hr), annualized to 66.7 hr and $4,297.33.
    Section 438.334(c)(3) outlines the process for a state to make 
changes to an approved alternative MMC QRS. We estimate that it will 
require 5 hr at $36.54/hr for an office and administrative support 
worker and 25 hr at $64.46/hr for a business operations specialist to 
complete the public comment process, and an additional 5 hr at $64.46/
hr from a business operations specialist to seek and receive approval 
from CMS for the change. While we have no data to estimate how 
frequently a state may elect to alter an approved alternative MMC QRS, 
we estimate that CMS will revise the MMC QRS under Sec.  438.334(b) on 
average approximately once every three years. We assume that states 
will revise their alternative QRS on a similar frequency (once every 
three years) to ensure that the alternative QRS continues to yield 
substantially comparable information regarding MCO, PIHP, and PAHP 
performance, and apply this assumption here. Therefore, we estimate an 
aggregate annualized burden of 116.7 hr

[[Page 27784]]

[(10 states x 35 hr)/3 years] and $7,055 [(10 states x ((5 hr x $36.54/
hr) + (30 x $64.46/hr)))/3 years].
    Under Sec.  438.334(d), each state will collect information from 
its MCOs, PIHPs, and PAHPs to calculate and then issue a quality rating 
each year. We expect that states will rely on information and data 
already provided to them by their MCOs, PIHPs, and PAHPs; therefore, we 
do not expect this data collection to pose an additional burden on the 
private sector. However, each year states will rate each MCO, PIHP, or 
PAHP with which they contract. We estimate 40 hr at $64.46/hr for a 
business operations specialist for a state to rate a MCO, PIHP, or 
PAHP. We believe this burden will be similar for states regardless of 
if they adopt the CMS-developed MMC QRS consistent with Sec.  
438.334(b) or the alternative MMC QRS consistent with Sec.  438.334(c). 
In aggregate, we estimate an annual state burden of 22,080 hr (552 
MCOs, PIHPs, and PAHPs x 40 hr) and $1,423,276.80 (22,080 hr x $64.46/
hr).
    Section 438.334(e) requires states to prominently display quality 
rating information for plans on the state Web site described in Sec.  
438.10. The burden associated with this process is captured in Sec.  
438.10.
    We received the following comments regarding the proposed ICRs 
regarding the MMC QRS:
    Comment: One commenter stated that the estimate for the creation of 
the MMC QRS was not realistic and was extremely understated. This 
commenter did not believe that the estimate adequately addressed the 
administrative burden for creating a rating system, and disagreed with 
the assumption that all of the data required for a MMC QRS is readily 
available in a useable format. Another commenter noted that a state 
ratings system will incur costs related to design, development, 
training, and implementation.
    Response: CMS did not have experience on which to base the 
estimated burden for the MMC QRS. Therefore, we give deference to the 
commenters' concerns, and we increased the estimated hours associated 
with each component of the MMC QRS burden in the final rule. We also 
note that this estimate takes into account the technical assistance 
available to states from CMS, both in the form of a CMS-developed MMC 
QRS available for adoption (and guidance, in the case of alternative 
QRS) and to support the development of alternative MMC QRS.
23. ICRs Regarding Managed Care State Quality Strategy (Sec.  438.340, 
formerly Sec.  438.204)
    In part 431 subpart I and Sec.  438.340, we proposed that states 
would maintain a written comprehensive quality strategy that applied to 
services provided through all delivery systems, including FFS and 
managed care. Proposed part 431 subpart I described the general rule 
for the CQS, the CQS elements, the development and revision process, 
and connected the CQS to the managed care quality strategy elements in 
proposed Sec.  438.340, which would apply to states contracting with 
MCOs, PIHPs, PAHPs, and some PCCM entities. Based on public comment, we 
are not finalizing the requirement for a CQS as described in proposed 
part 431 subpart I. However, we are continuing to require a managed 
care quality strategy (which applies to states contracting with MCOs, 
PIHPs, PAHPs, and PCCM entities described in Sec.  438.310(c)(2)), and 
are redesignating sections from proposed part 431 subpart I into Sec.  
438.340 of the final rule. The general rule for the managed care 
quality strategy is redesignated at Sec.  438.340(a) and is a revised 
version of the general rule from proposed Sec.  431.502(a). Section 
438.340(b) of the final rule describes the required elements of the 
managed care quality strategy, and combines the language from proposed 
Sec. Sec.  431.502(b) and 438.340. It also contains additional 
revisions to reflect cross-references from other sections and responses 
to public comment. This includes the addition of an element focused on 
the state's plan to identify, evaluate, and reduce health disparities, 
which incorporates the requirement previously located at Sec.  
438.204(b)(2) that states provide certain demographic information to 
MCOs and PIHPs at the time of enrollment. Proposed Sec.  431.504 is 
finalized as Sec.  438.340(c) with revisions to reflect the more 
limited scope (to Medicaid managed care) and for clarity. Proposed 
Sec.  431.504(d) is finalized as Sec.  438.340(d) with minor revisions. 
For additional discussion of these revisions, please see section 
I.B.6.b(2)(f).
    While a PRA-related public comment was received with regard to our 
proposed requirements and burden estimates, we have considered the 
comment and are not revising our burden estimates in response to these 
PRA-related comment. However, our finalized burden estimates for Sec.  
438.340 have been revised to reflect the finalized version of this 
section (which takes into account non-PRA-related comments), and minor 
adjustments to hourly rates. See below for our finalized provisions/
estimates along with a summary of the comments and our response.
    Previous regulations at Sec.  438.204(b)(2) described a quality 
strategy element, specifically that states contracting with MCOs and/or 
PIHPs identify the race, ethnicity, and primary language spoken of each 
Medicaid enrollee, and report this information to MCOs and PIHPs upon 
enrollment into a plan. While we had inadvertently proposed to delete 
this quality strategy element, under the final rule we are retaining 
this element and incorporating it into Sec.  438.340(b)(6), which 
requires states to include a plan to identify, evaluate, and reduce 
health disparities in the managed care quality strategy. Therefore, 
under the final rule there is a burden on states to provide the 
identified demographic data (age, race, ethnicity, sex, primary 
language, and disability status) to MCOs, PIHPs, and PAHPs. The burden 
associated with previous regulations at Sec.  438.204(b)(2) was 
estimated at 80 hr per state (for 15 states) to complete the 
programming necessary to collect and report on the race, ethnicity, and 
primary language spoken, for an aggregate burden of 1,200 hr (15 states 
x 80 hr) (note that the previous burden did not include an associated 
hourly wage). We are replacing that burden with a new estimate to 
account for the additional demographic information which states must 
provide to MCOs, PIHPs, and PAHPs under Sec.  438.340(b)(6). Assuming 
that the estimated 40 states that contract with MCOs, PIHPs, and PAHPs 
provide demographic information electronically to these plans once each 
year, we estimate a burden for the reporting of these six demographic 
factors to MCOs, PIHPs, and PAHPs of 130 hr, half at $64.46/hr for a 
business operations analyst and half at $36.54/hr for an office and 
administrative support worker. In aggregate, we estimate an ongoing 
annual state burden of 5,200 hr (130 hr x 40 states) and $262,600 [40 
states x ((65 hr x $64.46/hr) + (65 hr x $36.54/hr))].
    In accordance with Sec.  438.340(c)(2), states will review and 
revise their quality strategies as needed, but no less frequently than 
once every 3 years. While the 37 states that contract with MCOs and/or 
PIHPs currently revise their quality strategies periodically, 
approximately half of those states (18) revise their quality strategies 
less frequently than proposed. We estimate a burden for the revision of 
a quality strategy of, once every 3 years, 25 hr at $64.46/hr for a 
business operations analyst to review and revise the comprehensive 
quality strategy, 2 hr at $36.54/hr for an office and administrative 
support worker to

[[Page 27785]]

publicize the strategy, 5 hr at $64.46/hr for a business operations 
specialist to review and incorporate public comments, and 1 hr at 
$36.54/hr for an office and administrative support worker to submit the 
revised quality strategy to CMS. In aggregate, we estimate an ongoing 
annualized state burden of 198 hr [(18 states x (33 hr)/3 years] and 
$12,260.52 [(18 states x ((30 hr x $64.46/hr) + (3 hr x $36.54/hr)))/3 
years].
    The revision of a quality strategy will be a new process for the 
estimated three states with only PAHPs and the estimated two states 
with only PCCM entities. We estimate that those states need 0.5 hr at 
$64.46/hr for a business operations specialist to revise their policies 
and procedures. We are annualizing the one-time development burden 
since we do not anticipate any additional development burden after the 
3-year approval period expires. In aggregate, we estimate a one-time 
state burden of 2.5 hr (5 states x 0.5 hr) and $161.15 (2.5 hr x 
$64.46/hr), annualized to 0.8 hr and $53.72, to update policies and 
procedures.
    We assume that it will be less burdensome to revise an existing 
quality strategy than to draft an initial strategy. Therefore, we 
estimate an ongoing burden for the quality strategy revision process 
for states with only PAHPs and PCCM entities, once every 3 years, of 25 
hr at $64.46/hr for a business operations analyst to review and revise 
the comprehensive quality strategy, 2 hr at $36.54/hr for an office and 
administrative support worker to publicize the strategy, 5 hr at 
$64.46/hr for a business operations specialist to review and 
incorporate public comments, and 1 hr at $36.54/hr for an office and 
administrative support worker to submit the revised quality strategy to 
CMS. In aggregate, we estimate an ongoing annualized state burden of 55 
hr [(5 states x (33 hr)/3 years] and $3,405.70 [(5 states x ((30 hr x 
$64.46/hr) + (3 hr x $36.54/hr)))/3 years].
    Consistent with Sec.  438.340(c)(2), the review of the quality 
strategy will include an effectiveness evaluation conducted within the 
previous 3 years. We estimate the burden of this evaluation at 40 hr at 
$64.46/hr for a business operations specialist once every 3 years for 
all 42 states that contract with MCOs, PIHPs, PAHPs, and/or PCCM 
entities (described in Sec.  438.310(c)(2)). The currently approved 
burden estimates for creating and submitting an implementation and 
effectiveness report to CMS for the 37 states with MCOs and/or PIHPs 
takes 40 hr per state once every 3 years, for an annualized burden of 
493.3 hr [(37 states x 40hr)/3]; therefore, the only new burden is 
associated with the estimated 3 states with only PAHPs and the 
estimated 2 states with only PCCM entities. Therefore, we estimate a 
net ongoing annualized burden of 66.7 hr [((42 states x 40 hr) - (37 
states x 40 hr))/3 years] and $4,299.48 (66.7 hr x $64.46/hr) to 
evaluate the effectiveness of a quality strategy.
    Section Sec.  438.340(c)(2)(ii) requires states to post the managed 
care quality strategy effectiveness evaluation on the state's Medicaid 
Web site. In the proposed rule we stated that while this standard was 
subject to the PRA, we believed that the associated burden was exempt 
from the PRA in accordance with 5 CFR 1320.3(b)(2). We believed that 
the time, effort, and financial resources necessary to comply with the 
aforementioned standards would be incurred by persons during the normal 
course of their activities and, therefore, should be considered a usual 
and customary business practice. Upon further consideration, however, 
we determined that states today do not necessarily post the quality 
strategy effectiveness evaluation online. Therefore, we estimate that 
posting the quality strategy effectiveness evaluation online will 
require 0.25 hr at $64.46 from a business operations specialist once 
every 3 years. In aggregate, we estimate an ongoing annualized burden 
of 3.5 hr [(42 states x 0.25 hr)/3 years] and $225.61 (3.5 hr x $64.46/
hr).
    As described in Sec.  438.340(c)(3), states will submit to CMS a 
copy of the initial quality strategy and any subsequent revisions. The 
burden associated with this standard has been incorporated into burden 
estimates for initial and revised quality strategies. As this will be a 
new standard for the estimated 3 states with only PAHPs and the 
estimated 2 states with only PCCM entities, we believe that these 
states will need to modify their policies and procedures to incorporate 
this action. We estimate a burden of 0.5 hr at $64.46/hr for a business 
operations specialist. We are annualizing the one-time development 
burden since we do not anticipate any additional development burden 
after the 3-year approval period expires. In aggregate, we estimate a 
one-time state burden of 2.5 hr (5 states x 0.5 hr) and $161.15 (2.5 hr 
x $64.46/hr), annualized to 0.8 hr and $53.72.
    Section 438.340(d) requires states to post the final quality 
strategy to their Medicaid Web sites. In the proposed rule, we stated 
that while this standard is subject to the PRA, we believed that the 
associated burden was exempt from the PRA in accordance with 5 CFR 
1320.3(b)(2). We believed that the time, effort, and financial 
resources necessary to comply with the aforementioned standards would 
be incurred by persons during the normal course of their activities 
and, therefore, should be considered a usual and customary business 
practice. Upon further consideration, however, we determined that 
states today do not necessarily post the final quality strategy online, 
though some do. Therefore, we estimate that posting the final quality 
strategy online will require 0.25 hr at $64.46 from a business 
operations specialist once every 3 years. In aggregate, we estimate an 
ongoing annualized burden of 3.5 hr [(42 states x 0.25 hr)/3 years] and 
$225.61 (3.5 hr x $64.46/hr).
    We received the following comments regarding the proposed ICRs 
regarding the managed care State quality strategy:
    Comment: One commenter noted that the proposed CQS (along with the 
proposed changes to QAPI and EQR) drove the new burden associated with 
the proposed quality revisions. The commenter believed that the costs 
estimates for this proposal seemed understated, and that state might 
not be able to successfully bear this burden without consideration of a 
temporary enhanced match or other funding.
    Response: We are withdrawing the proposed Part 431, Subpart I, but 
retaining the requirement for a managed care quality strategy, 
described in Sec.  438.340 of the final rule. With this change, we 
moved the burden associated with the proposed new Part 431, Subpart I 
to Sec.  438.340, where it largely replaced the burden associated with 
proposed Sec.  438.340. Given that we will not apply the QS 
requirements to FFS delivery systems, we do not believe the burden is 
understated and decline to revise the estimate.
24. ICRs Regarding External Quality Review (Sec.  438.350)
    While the proposed rule expanded EQR to PAHPs (it already applied 
to MCOs and PIHPs), we did not develop a burden estimate for Sec.  
438.350, though we did for other EQR provisions. Upon further 
consideration, and in light of the clarification in 438.310(c)(2) that 
certain PCCM entities will be required to undergo an annual EQR, we 
have determined it necessary to develop a burden for the amendment of 
EQRO contracts in states with MCOs and PIHPs which we assume will amend 
existing EQRO contracts to include PAHPs and PCCM entities.
    We estimate that there are 12 states that contract with PAHPs (of 
which 3 states contract with only PAHPs) and 5 states that contract 
with PCCM entities

[[Page 27786]]

which will be required to undergo an annual EQR (of which 2 states 
contract only with PCCM entities). Therefore, we estimate that there 
are 17 states that contract with PAHPs or PCCM entities in addition to 
MCOs and PIHPs which will amend their existing EQRO contracts. We 
estimate a one-time burden of 1 hr at $64.46/hr for a business 
operations specialist to amend the EQRO contract. We are annualizing 
the one-time development burden since we do not anticipate any 
additional development burden after the 3-year approval period expires. 
In aggregate, we estimate a one-time state burden of 17 hr (17 states x 
1 hr) and $1,095.82 (17 hr x $64.46/hr), annualized to 5.7 hr and 
$365.27.
25. ICRs Regarding Activities Related to External Quality Review (Sec.  
438.358)
    Proposed Sec.  438.3(r) stated that PCCM entities whose contract 
with the state provides for shared savings, incentive payments or other 
financial reward for improved quality outcomes would be subject to EQR. 
However, proposed Sec.  438.350(b) and its associated preamble, 
inaccurately described EQR as optional for these PCCM entities (see 
section I.B.6.b(2)(h) for additional discussion). In the final rule, we 
clarified that EQR of PCCM entities (described in Sec.  438.310(c)(2) 
of the final rule) are required to undergo an annual EQR. Therefore, we 
are revising this ICR to include the burden associated with conducting 
the EQR-related activities on PCCM entities (described in Sec.  
438.310(c)(2) of the final rule). Additionally, in response to public 
comments, we are finalizing an optional EQR-related activity at Sec.  
438.358(c)(6) of the final rule which can assist states with the 
quality rating of MCOs, PIHPs, and PAHPs (for additional discussion, 
see section I.B.6.b(2)(e)).
    While a PRA-related public comment was received with regard to our 
proposed requirements and burden estimates, we have considered the 
comment and are not modifying this estimate in response to the comment. 
However, we are revising this ICR to reflect the changes described 
above and minor adjustments to hourly rates. See below for our 
finalized provisions/estimates along with a summary of the comment and 
our response.
    Section 438.358 addresses the EQR-related activities. Per Sec.  
438.358(a)(1), the EQR-related activities described in paragraphs (b) 
and (c) of this section may be conducted by the state, its agent that 
is not an MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)), or an EQRO; we describe the burden assuming that the 
state conducts these activities, though we believe the burdens will be 
similar regardless of who conducts each activity.
    The burden associated with the mandatory EQR-related activities 
described in Sec.  438.358(b)(1) is the time and effort for a state to 
conduct and document the findings of the four mandatory activities: (1) 
The annual validation of PIPs conducted by the MCO, PIHP, or PAHP, (2) 
the annual validation of performance measures calculated by the MCO, 
PIHP, or PAHP, (3) a review of MCO, PIHP, or PAHP compliance with 
structural and operational standards, performed once every 3 years; and 
(4) validation of MCO, PIHP, or PAHP network adequacy during the 
preceding 12 months. Each of the activities will be conducted on the 
552 MCOs, PIHPs, and PAHPs that we estimate provide Medicaid services.
    The types of services provided by MCOs, PIHPs, and PAHPs, and the 
number of PIPs conducted and performance measures calculated will vary. 
The previously approved burden under control number 0938-0786 (CMS-R-
305) for these three activities assumed that each of the then-estimated 
458 MCOs and PIHPs validate one PIP by a professional at $63/hr for 65 
hr, validate one performance measure by a professional at $63/hr for 53 
hr, and complete an annual a compliance review by a professional at 
$63/hr for 361 hr. The previously approved annual burden was 219,382 hr 
(479 hr x 458 MCOs and PIHPs) and $13,821,066 (219,382 hr x $63/hr). 
However, based on recent experience (for MCOs and PIHPs), we estimate 
that each MCO or PIHP will conduct 3 PIPs, each PAHP will conduct 1 
PIP, and that each MCO, PIHP, or PAHP will calculate 3 performance 
measures. Furthermore, using the time estimates developed for MCOs and 
PIHPs for the previously approved burden estimates under control number 
0938-0786 (CMS-R-305) (and assuming that the same time estimates will 
also apply to PAHPs), we estimate it will take an average of 65 hr/PIP 
validation, 53 hr/performance measure validation, and 361 hr/compliance 
review (occurs once every 3 years) for a business operations 
specialist, at $64.46/hr, to conduct the mandatory EQR activities. For 
MCOs and PIHPS, we estimate an annual state burden of 242,367.3 hr (511 
MCOs and PIHPs x [(65 hr x 3 PIPs) + (53 hr x 3 performance measures) + 
(361 hr/3 year)]) and $15,622,996.16 (242,367.3 hr x $64.46/hr) for the 
first three mandatory EQR-related activities. This estimate replaces 
the previous burden; the net change in annual state burden for MCOs and 
PIHPs is 22,985.3 hr (242,367.3 hr-219,382 hr) and $1,801,930.16 
($15,622,996.16 - $13,821,066).
    For PAHPs, we estimate an aggregate annual state burden of 14,116.3 
hr (41 PAHPs x 344.3 hr [(65 hr x 1 PIPs) + (53 hr x 3 performance 
measures) + (361 hr/3 years)]) and $909,936.70 (14,116.3 hr x $64.46/
hr) for the first three mandatory EQR-related activities.
    The fourth mandatory EQR-related activity described in Sec.  
438.358(b)(1)(iv) requires the validation of MCO, PIHP, and PAHP 
network adequacy during the preceding 12 months. States will conduct 
this activity for each MCO, PIHP, and PAHP. Given that this is a new 
activity, we do not have historic data on which to base an hourly 
burden estimate for the network validation process. We estimate that it 
will take less time than the validation of a PIP but more time than the 
validation of a performance measure. Therefore, we estimate an annual 
state burden of 60 hr at $64.46/hr for a business operations specialist 
to support the validation of network adequacy activity. In aggregate, 
we estimate 33,120 hr (552 MCOs, PIHPs, and PAHPs x 60 hr) and 
$2,134,915.20 (33,120 hr x $64.46/hr) for the validation of network 
adequacy activity.
    Section 438.358(b)(2) describes the mandatory EQR-related 
activities which must be conducted for each PCCM entity (described in 
Sec.  438.310(c)(2)), specifically the activities described in Sec.  
438.358(b)(1)(ii) and (iii). Given that we do not have data to estimate 
the time required for each of these activities for these PCCM entities, 
we rely on the time per activity estimates used for MCOs, PIHPs, and 
PAHPs; we assume the validation of one performance measure per PCCM 
entity (described in Sec.  438.310(c)(2)). Therefore, we estimate an 
annual state burden of 1,560 hr (9 PCCM entities x 173.3 hr [(53 hr x 1 
performance measure) + (361 hr/3 years)]) and $100,557.60 (1,560 hr x 
$64.46/hr) for the mandatory EQR-related activities for PCCM entities 
(described in Sec.  438.310(c)(2)).
    The burden associated with Sec.  438.358(b)(1) also includes the 
time for an MCO, PIHP, or PAHP to prepare the information necessary for 
the state to conduct the mandatory EQR-related activities. We estimate 
that it will take each MCO, PIHP, or PAHP 200 hr to prepare the 
documentation for these four activities, half (100 hr) at $64.46/hr by 
a business operations specialist and half (100 hr) at $36.54/hr by an 
office and administrative support worker. The burden associated with 
Sec.  438.358(b)(2) also includes the time

[[Page 27787]]

for a PCCM entity (described in Sec.  438.310(c)(2)) to prepare the 
information necessary for the state to conduct the mandatory EQR-
related activities. Given the estimate of 200 hr for an MCO, PIHP, or 
PAHP, and that there are only 2 mandatory EQR-related activities for 
PCCM entities (described in Sec.  438.310(c)(2)), we estimate it will 
take 100 hr to prepare the documentation for these 2 activities, half 
(50 hr) at $64.46/hr by a business operations specialist and half (50 
hr) at $36.54/hr by an office an administrative support worker. In 
aggregate, we estimate an annual private sector burden of 111,300 hr 
[(552 MCOs, PIHPs, and PAHPs x 200 hr) + (9 PCCM entities x 100 hr)] 
and $5,620,650 [(55,650 hr x $64.46/hr) + (55,650 hr x $36.54/hr)]. The 
previously approved burden under control number 0938-0786 (CMS-R-305) 
estimated 160 hr per MCO or PIHP to prepare the information for the 
three existing mandatory EQR-related activities (finalized as Sec.  
438.358(b)(1)(i) through (iii)), half by a professional at $63/hr and 
half by clerical staff at $12/hr. The previously approved burden for 
information preparation is 73,280 hr (438 MCOs and PIHPs x 160 hr) and 
$2,748,000 [(36,640 hr x $63/hr) + (36,640 hr x $12/hr)]. When 
comparing the previously approved burden against this final rule's 
revised burden, we estimate a change in burden of 38,020 hr (111,300 
hr-73,280 hr) and $2,872,650 ($5,620,650 - $2,748,000) for the 
preparation of information for the mandatory EQR-related activities 
described in Sec.  438.358(b)(1) and (b)(2). We note that in the 
proposed rule, Table 2 identified the net burden associated with the 
time for an MCO, PIHP, or PAHP to prepare the information necessary for 
the state to conduct the mandatory EQR-related activities in proposed 
Sec.  438.358(b)(1). In this final rule, Table 2a shows the revised 
burden for this activity.
    Section 438.358(c) describes the six optional EQR-related 
activities: (1) Validation of client level data (such as claims and 
encounters); (2) administration or validation of consumer or provider 
surveys; (3) calculation of performance measures; (4) conduct of PIPs; 
(5) conduct of focused studies; and (6) assist with the quality rating 
of MCOs, PIHPs, and PAHPs consistent with Sec.  438.334. As with the 
mandatory activities described in Sec.  438.358(b), these activities 
may be conducted by the state, its agent that is not an MCO, PIHP, or 
PAHP, or an EQRO, but for the purposes of this burden estimate we 
assume that the state conducts the activities.
    We have no data to estimate the hours associated with how long it 
will take to conduct the optional EQR activities. Without that 
information, our best guess is that it will take 350 hr to validate 
client level data and 50 hr to validate consumer or provider surveys. 
We estimate it will take three times as long to calculate performance 
measures (159 hr) as it takes on average to validate and three times as 
long to conduct PIPs and focused studies (195) as it takes on average 
to validate PIPs. We also estimate that it will take three times as 
long to administer a consumer or provider survey than it takes to 
validate a survey (150 hr).
    The previously approved burden under control number 0938-0786 (CMS-
R-305) uses state-reported data from 2001 to estimate that states will: 
(1) Validate the encounter data of 69 percent (316) of MCOs and PIHPs; 
(2) administer or validate consumer or provider surveys of 43 percent 
(197) of MCOs and PIHPs; (3) calculate performance measures of 29 
percent (133) of MCOs and PIHPs; (4) conduct PIPs of 38 percent (174) 
of MCOs and PIHPs; and (5) conduct focused studies of 76 percent (348) 
of MCOs and PIHPs. Using the hourly estimates (above) for each task and 
assuming the work is completed by a professional at $63/hr (the job 
title and wage used in the previously approved burden under control 
number 0938-0786 (CMS-R-305)), CMS-R-305 previously estimated a total 
burden of 240,759 hr and $15,167,817. However, based on our review of 
EQR technical report submissions since the original promulgation of 
these regulations, we have observed that many states do not conduct the 
optional EQR-related activities as frequently as assumed in our 
original estimates. While the exact states and number vary from year to 
year, we have not observed participation at the level observed in 2001 
state-reported data.
    Therefore, we revise our estimate and assume that each year 10 
percent (51) of MCOs and PIHPs will be subject to each of the optional 
EQR-related activities. Regarding the administration or validation of 
consumer or provider surveys, we assume that half of the MCOs and PIHPs 
(25) will administer surveys while half (26) will validate surveys. We 
also estimate that a mix of professionals will work on each optional 
EQR-related activity: 20 Percent by a general and operations manager 
($140.80/hr); 25 percent by a computer programmer ($78.32/hr); and 55 
percent by a business operations specialist ($64.46/hr). For the 
purposes of this estimate, we assume that the 10 percent of affected 
MCOs and PIHPs operate within 10 percent of states that contract with 
MCOs and PIHPs (4 states). We understand that this estimate may not 
reflect the number of states that require these optional EQR-related 
activities, and that there is variation in the number of plans that 
operate within a given state.
    To validate client level data, we estimate 17,850 hr (51 MCOs and 
PIHPs x 350 hr) and $1,484,995.05 [(17,850 hr x 20 percent x $140.80/
hr) + (17,850 hr x 25 percent x $78.32/hr) + (17,850 hr x 55 percent x 
$64.46/hr)]. To administer consumer or provider surveys, we estimate 
3,750 hr (25 MCOs and PIHPs x 150 hr) and $311,973.75 [(3,750 hr x 20 
percent x $140.80/hr) + (3,750 hr x 25 percent x $78.32/hr) + (3,750 hr 
x 55 percent x $64.46/hr)]. To validate consumer or provider surveys, 
we estimate 1,300 hr (26 MCOs and PIHPs x 50 hr) and $108,150.90 
[(1,300 hr x 20 percent x $140.80/hr) + (1,300 hr x 25 percent x 
$78.32/hr) + (1,300 hr x 55 percent x $64.46/hr)]. To calculate 
performance measures, we estimate 8,109 hr (51 MCOs and PIHPs x 159 hr) 
and $674,612.04 [(8,109 hr x 20 percent x $140.80/hr) + (8,109 hr x 25 
percent x $78.32/hr) + (8,109 hr x 55 percent x $64.46/hr)]. To conduct 
PIPs, we estimate 9,945 hr (51 MCOs and PIHPs x 195 hr) and $827,354.39 
[(9,945 hr x 20 percent x $140.80/hr) + (9,945 hr x 25 percent x 
$78.32/hr) + (9,945 hr x 55 percent x $64.46/hr)]. To conduct focused 
studies, we estimate 9,945 hr (51 MCOs and PIHPs x 195 hr) and 
$827.354.39 [(9,945 hr x 20 percent x $140.80/hr) + (9,945 hr x 25 
percent x $78.32/hr) + (9,945 hr x 55 percent x $64.46/hr)]. In 
aggregate, the annual state burden for optional EQR-related activities 
for MCOs and PIHPs is 50,899 hr (17,850 hr + 3,750 hr + 1,300 hr + 
8,109 hr + 9,945 hr + 9,945 hr) and $4,234,440.51 [(50,899 hr x 20 
percent x $140.80/hr) + (50,899 hr x 25 percent x $78.32/hr) + (50,899 
hr x 55 percent x $64.46/hr)].
    The optional EQR-related activities described in Sec.  438.358(c) 
may also be conducted on PAHPs and PCCM entities (described in Sec.  
438.310(c)(2)). Since neither PAHPs or PCCM entities (described in 
Sec.  438.310(c)(2)) have historically been subject to EQR, we do not 
have any data on which to base an estimate regarding how states will 
apply the optional EQR-related activities to these delivery systems. 
Therefore, we will apply the time, wage, and participation estimates 
developed for MCOs and PIHPs to PAHPs and PCCM entities (described in 
Sec.  438.310(c)(2)). To validate client level data, we estimate 2,100 
hr (6 PAHPs and PCCM

[[Page 27788]]

entities x 350 hr) and $174,705.30 [(2,100 hr x 20 percent x $140.80/
hr) + (2,100 hr x 25 percent x $78.32/hr) + (2,100 hr x 55 percent x 
$64.46/hr)]. To administer consumer or provider surveys, we estimate 
450 hr (3 PAHPs and PCCM entities x 150 hr) and $21,981 [(450 hr x 20 
percent x $140.80/hr) + (450 hr x 25 percent x $78.32/hr) + (450 hr x 
55 percent x $64.46/hr)]. To validate consumer or provider surveys, we 
estimate 150 hr (3 PAHPs and PCCM entities x 50 hr) and $12,478.95 
[(150 hr x 20 percent x $140.80/hr) + (150 hr x 25 percent x $78.32/hr) 
+ (150 hr x 55 percent x $64.46/hr)]. To calculate performance 
measures, we estimate 954 hr (6 PAHPs and PCCM entities x 159 hr) and 
$79,366.12 [(954 hr x 20 percent x $140.80/hr) + (954 hr x 25 percent x 
$78.32/hr) + (954 hr x 55 percent x $64.46/hr)]. To conduct PIPs, we 
estimate 1,170 hr (6 PAHPs and PCCM entities x 195 hr) and $97,335.81 
[(1,170 hr x 20 percent x $140.80/hr) + (1,170 hr x 25 percent x 
$78.32/hr) + (1,170 hr x 55 percent x $64.46/hr)]. To conduct focused 
studies, we estimate 1,170 hr (6 PAHPs and PCCM entities x 195 hr) and 
$97,335.81 [(1,170 hr x 20 percent x $140.80/hr) + (1,170 hr x 25 
percent x $78.32/hr) + (1,170 hr x 55 percent x $64.46/hr)]. In 
aggregate, the total annual state burden for optional EQR-related 
activities for PAHPs and PCCM entities (described in Sec.  
438.310(c)(2)) is 5,994 hr (2,100 hr + 450 hr + 150 hr + 954 hr + 1,170 
hr + 1,170 hr) and $498,658.84 [(5,994 hr x 20 percent x $140.80/hr) + 
(5,994 hr x 25 percent x $78.32/hr) + (5,994 hr x 55 percent x $64.46/
hr)].
    Section 438.358(c)(6) allows a state to contract with an EQRO to 
support the quality rating of MCOs, PIHPs, and PAHPs consistent with 
Sec.  438.334. We do not believe that the effort required to rate a 
plan changes based on which entity (state or EQRO) develops the plan 
rating. Therefore, we believe that any burden associated with this 
optional EQR-related activity will only offset the burden associated 
with Sec.  438.334(d).
    We received the following comments regarding the proposed ICRs 
regarding the activities related to EQR:
    Comment: One commenter noted that the proposed changes to EQR 
(along with the proposed changes to QAPI and the proposed CQS) drove 
the new burden associated with the proposed quality revisions. The 
commenter believed that the cost estimates for these changes seemed 
understated, and that state might not be able to successfully bear this 
burden without consideration of a temporary enhanced match or other 
funding.
    Response: While the commenter believed that the EQR estimates were 
understated, it is not clear to us in what respect that is the case. We 
developed the EQR estimates based off of established estimates for MCOs 
and PIHPs for this topic and our experience via EQR technical report 
submissions. We note that these are estimates, and actual states 
practices and implementation may cause actual experience to be more, 
less or the same as these estimates. Without clearer direction as to 
where our estimate is lacking, we decline to revise the EQR burden 
estimates. We also note that there is an enhanced 75 percent match rate 
available for EQR and EQR-related activities conducted by an EQRO on an 
MCO (see Sec.  438.370); we lack statutory authority to provide any 
additional enhanced match rate or other financial support for EQR and 
EQR-related activities.
26. ICRs Regarding Nonduplication of Mandatory Activities (Sec.  
438.360)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.360(a) grants states the option to use the information 
obtained from a Medicare or private accreditation review of an MCO, 
PIHP, or PAHP in place of information otherwise generated from the 
three mandatory activities specified in Sec.  438.358(b)(1)(i) through 
(iii). Specifically, this section allows states to apply the non-
duplication option to all MCOs, PIHPs, and PAHPs and it allows states 
to apply the non-duplication option to the validation of performance 
measures, the validation of PIPs, and to the compliance review. Section 
438.360(c) requires states to address the use of non-duplication as an 
element of the quality strategy.
    Section 438.360(b) describes when a state may elect to use 
information from a Medicaid or private accreditation review in place of 
information that would otherwise be generated by the mandatory EQR-
related activities in Sec.  438.358(b)(1)(i) through (iii). The burden 
associated with non-duplication is the time and effort for an MCO, 
PIHP, or PAHP to disclose the reports, findings, and other results of 
the Medicare or private accreditation review to the state agency.
    While states could elect to allow all 552 MCOs, PIHPs, and PAHPs to 
substitute information from a Medicare or private accreditation review 
for the three mandatory EQR-related activities specified at Sec.  
438.358(b)(1)(i) through (iii), in practice we find that states utilize 
this option infrequently. Therefore, we estimate that states will apply 
the non-duplication option to 10 percent (55) of MCOs (33), PIHPs (18), 
and PAHPs (4). The currently approved burden under control number 0938-
0786 (CMS-R-305)) estimates that 336 MCOs and/or PIHPs take advantage 
of the nonduplication provision, requiring 8 hr at $37.50/hr per MCO or 
PIHP to disclose the necessary information to the state, for a total 
currently approved burden of 2,688 hr (336 MCOs and PIHPs x 8 hr) and 
$100,800 (2,688 hr x $37.50/hr). Since this appears to be an 
overestimate of the burden for MCOs and PIHPs, we estimate a revised 
annual private sector burden of 2 hr at $64.46/hr for a business 
operations specialist and 6 hr at $36.54/hr for an office and 
administrative support worker to disclose the necessary documentation 
to the state each year for a single MCO or PIHP. In aggregate, we 
estimate a private sector burden of 408 hr (51 MCOs and PIHPs x 8 hr) 
and $17,756.16 [(51 MCOs and PIHPs x (2 hr x $64.46/hr) + (6 hr x 
$36.54/hr)]. Under this rule, states may apply the nonduplication 
provisions to PAHPs. In aggregate, we estimate 32 hr (4 PAHPs x 8 hr) 
and $1,392.64 [4 PAHPs x (2 hr x $64.46/hr) + (6 hr x $36.54/hr)].
    The process in Sec.  438.360(b) includes the provision of all of 
the reports, findings, and other results of the Medicare or private 
accreditation review to the appropriate EQRO by the state agency. The 
currently approved burden under control number 0938-0786 (CMS-R-305) 
estimates that sharing the reports, findings, and results with EQROs 
for 336 MCOs and PIHPs will take states 8 hr at $37.50/hr per plan, for 
a total burden of 2,688 hr (336 MCOs x 8 hr) and $100,800 (2,688 hr x 
$37.50/hr). However, we estimate it will take, on average, 2 hr at 
$36.54/hr for an office and administrative support worker to disclose 
the necessary documentation to the appropriate EQRO. This represents a 
decrease in the estimated hourly burden for this task, as we believe 
that the use of electronic tracking and transmission tools has 
significantly decreased the hourly burden associated with state staff 
forwarding the documentation to the EQRO. In aggregate, we estimate an 
annual state burden of 110 hr (55 MCOs, PIHPs, and PAHPs x 2 hr) and 
$4,019.40 (110 hr x $36.54/hr) to forward non-duplication-related 
documentation to the EQROs.
    Assuming that states will apply the non-duplication provision to 10 
percent of MCOs, PIHPs, and PAHPs, we

[[Page 27789]]

estimate that this provision will offset the burden associated with 
Sec.  438.358(b)(1)(i) through (iii) for 51 MCOs and PIHPs, and 4 PAHPs 
(since these activities will no longer be necessary for these 55 
plans). Consistent with the estimates used in Sec.  438.358(b)(1)(i) 
through (iii), we estimate an aggregated state offset of -25,566.50 hr 
[(-51 MCOs and PIHPs x 474.3 hr) + (-4 PAHPs x 344.3 hr)] and -
$1,648,016.59 (-25,566.50 hr x $64.46).
    Additionally, the MCOs, PIHPs, and PAHPs subject to non-duplication 
will not have to prepare the documentation necessary for the three 
mandatory EQR-related activities. Based on the assumption in Sec.  
438.358(b)(1) that an MCO, PIHP, or PAHP will need 200 hr to prepare 
the documentation for the four mandatory activities, we estimate that 
it will take 150 hr to prepare the documentation for the three 
activities subject to non-duplication, half (100 hr) at $64.46/hr by a 
business operations specialist and half (100 hr) at $36.54/hr by an 
office and administrative support worker. In aggregate, we estimate a 
decrease in annual private sector burden of -8,250 hr (-55 MCOs, PIHPs, 
and PAHPs x 150 hr) and -$416,625 [(-4,125 hr x $64.46/hr) + (-4,125 x 
$36.54)].
27. ICRs Regarding Exemption From External Quality Review (Sec.  
438.362)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.362 reflects that PIHPs cannot be exempted from EQR, as 
they do not qualify as a MA Organization under part C of Title XVII of 
the Act or under section 1876 of the Act, and they do not qualify as an 
MCO under section 1903(m) of the Act. This led to a decrease in our 
estimate of the number of plans that might be exempt from the EQR 
process.
    Under Sec.  438.362, exempted MCOs have to provide (annually) to 
the state agency the most recent Medicare review findings reported to 
the MCO by CMS or its agent. Of the approximately 335 MCOs, we estimate 
that approximately half (168) might provide Medicare services in 
addition to Medicaid services. Of these 168 MCOs that might potentially 
provide Medicare services in addition to Medicaid services, we further 
estimate that state agencies will allow approximately 10 percent (17) 
of the MCOs to be exempt from the EQR process.
    We estimate an annual private sector burden of 8 hr (2 hr at 
$64.46/hr for a business operations specialist and 6 hr at $36.54/hr 
for an office and administrative support worker) for an MCO to prepare 
and submit the necessary documentation to the state agency. In 
aggregate, we estimate 136 hr (17 MCOs x 8 hr) and $5,918.72 (17 MCOs x 
[(2 hr x $64.46/hr) + (6 hr x $36.54/hr)]). The previously approved 
burden under control number 0938-0786 (CMS-R-305) estimated that states 
would allow 10 percent (20) of the 202 MCOs (which might provide 
Medicare services in addition to Medicaid services) to be exempt from 
the EQR process, and that it would take each MCO approximately 8 hr at 
$37.50/hr to prepare the necessary materials for a total burden of 160 
hr (20 MCOs x 8 hr) and $6,000 (160 hr x $37.50/hr). Therefore, we 
estimate a change in burden of -24 hr (136 hr -160 hr) and -$81.28 
($5,918.72-$6,000). We note that in the proposed rule, Table 2 
identified the net burden associated with Sec.  438.362; in this final 
rule, Table 2a shows the revised burden for this section.
28. ICRs Regarding External Quality Review Results (Sec.  438.364)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates and to reflect the mandatory application of 
EQR to PCCM entities described in Sec.  438.310(c)(2), which increases 
the estimated number of states impact by this section to 42. No 
comments were received.
    Section 438.364(a) describes the information that will be included 
in the annual detailed technical report that is the product of the EQR. 
Section 438.364(a)(1)(iii) specifies that the EQR technical report 
includes baseline and outcomes data regarding PIPs and performance 
measures. Many states already provide much of this information in their 
final EQR technical report. The burden of compiling this data for MCOs, 
PIHPs, PAHPs, and select PCCM entities is captured in Sec.  438.358. 
Under Sec.  438.364(a)(3), EQR technical reports will include 
recommendations on how the state can use the goals and objectives of 
its managed care quality strategy to support improvement in the 
quality, timeliness, and access to care for beneficiaries. We believe 
that states will amend their EQRO contracts to address the changes to 
Sec.  438.364(a). We estimate a one-time state burden of 0.5 hr at 
$64.46/hr for a business operations specialist to amend the EQRO 
contract in the estimated 37 states with existing EQRO contracts. We 
are annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. In 
aggregate, we estimate 18.5 hr (37 states x 0.5 hr) and $1,192.51 (18.5 
hr x $64.46/hr), annualized to 6.2 hr and $397.50. We believe that the 
5 states that contract only with PAHPs and PCCM entities will 
incorporate this section into their initial EQRO contracts, and 
therefore we do not believe there is an EQRO amendment burden 
associated with the changes to this section for those 5 states.
    Section 438.364(b)(1) clarifies that the EQRO will produce and 
submit to the state an annual EQR technical report, and that states may 
not substantively revise the report without evidence of error or 
omission. This is consistent with existing policy and should not pose a 
burden on the states or the private sector. The April 30th deadline for 
the finalization and submission of EQR technical reports is consistent 
with existing subregulatory guidance.
    While we do not anticipate that these changes would pose a 
significant burden on states or the private sector, we estimate that 
this provision may necessitate a change in a state's EQRO contract for 
approximately 10 states. In this regard, we estimate a one-time state 
burden of 0.5 hr at $64.46/hr for a business operations specialist to 
modify the EQRO contract. We are annualizing the one-time development 
since we do not anticipate any additional burden after the 3-year 
approval period expires. In aggregate, we estimate 5 hr (10 states x 
0.5 hr) and $322.30 (5 hr x $64.46/hr), annualized to 1.7 hr and 
$107.43.
    Under Sec.  438.364(c)(ii), each state agency will provide copies 
of technical reports, upon request, to interested parties such as 
participating health care providers, enrollees and potential enrollees 
of the MCO, PIHP, or PAHP, beneficiary advocacy groups, and members of 
the general public. States will also make the most recent EQR technical 
report publicly available on the state's Web site, the burden for which 
is included in Sec.  438.10.
    We believe that by making these reports available online, states 
will be able to significantly decrease the burden associated with 
responding to requests from the public for this information, as it will 
already be easily accessible. The burden associated with section is the 
time and effort for a state agency to furnish copies of a given 
technical report to interested parties. The currently approved burden 
under control number 0938-0786 (CMS-R-

[[Page 27790]]

305) estimates a burden of 91,600 hr and $1,099,200. This assumed 329 
MCOs and 129 PIHPs (for a total of 458), 25 requests per MCO or PIHP, 
and 8 hr to respond to each request by staff at $12/hr. In light of 
recent technological changes described in this section of this final 
rule, we estimate an annual state burden of 5 min (on average) at 
$36.54/hr for an office and administrative support worker to disclose 
the reports (per request), and that a state will receive five requests 
per MCO, PIHP, PAHP, or PCCM entity (described in Sec.  438.310(c)(2)) 
per year. In aggregate, we estimate 233.7 hr [(561 MCOs, PIHPs, PAHPs, 
and PCCM entities x 5 requests x 5 min)/60 min] and $8,539.40 (233.7 hr 
x $36.54/hr). Overall, we estimate a change in burden of -91,366.3 hr 
(233.7 hr-91,600 hr) and -$1,090,660.6 ($8,539.40-$1,099,200). We note 
that in the proposed rule, Table 2 identified the net burden associated 
with proposed Sec.  438.364(b)(2); in this final rule, Table 2a shows 
the revised burden for Sec.  438.364(c)(ii).
29. ICRs Regarding Federal Financial Participation (Sec.  438.370)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.370(c) will require states to submit their EQRO 
contracts to CMS for review and approval prior to claiming FFP at the 
75 percent rate. Since most states already consult with CMS regarding 
EQRO contracts, we estimate only 12 states will need to amend their 
policies and procedures to comply with this process. We estimate a one-
time state burden of 0.5 hr at $64.46/hr for a business operations 
specialist to amend their state's policies and procedures. We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. In 
aggregate, we estimate 6 hr (12 states x 0.5 hr) and $386.76 (6 hr x 
$64.46/hr), annualized to 2.0 hr and $128.92.
    The 12 states which do not currently work with CMS on their EQRO 
contracts will need to submit the EQRO contracts to CMS for review and 
approval if they plan to claim the enhanced 75 percent federal match. 
We estimate a one-time state burden of 0.25 hr at $36.54/hr for an 
office and administrative support worker to submit the EQRO contract to 
CMS. We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires. In aggregate, we estimate 3 hr (12 states x 0.25 hr) and 
$109.62 (3 hr x $36.54/hr), annualized to 1.0 hr and $36.54.
30. ICRs Regarding Statutory Basis and Definitions (Sec.  438.400)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.400(b) replaces ``action'' with ``adverse benefit 
determination'' and revises the definition. It also revises the 
definitions of ``appeal'' and ``grievance'' and add a definition for 
``grievance system.'' In response, states, MCOs and PIHPs need to 
update any documents where these terms are used. (PAHPs will use these 
updated definitions when they develop their systems in Sec.  438.402.)
    We estimate a one-time private sector burden of 5 hr at $64.46/hr 
for a business operations specialist to amend all associated documents 
to the new nomenclature and definitions. In aggregate, we estimate 
2,555 hr (335 MCO + 176 PIHP x 5 hr) and $164,695.30 (2,555 hr x 
$64.46/hr). We also estimate a one-time state burden for states of 200 
hr (40 states x 5 hr) and $12,892 (200 hr x $64.46/hr) to make similar 
revisions. We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires.
31. ICRs Regarding General Requirements for Grievance System (Sec.  
438.402)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.402(a) adds non-NEMT PAHPs to the existing requirement 
for MCOs and PIHPs to have a grievance system. There are 41 PAHPs that 
will need to have their contract amended. The burden for revising their 
contract is included in Sec.  438.3.
    To set up a grievance system, we estimate it takes 100 hr (10 hr at 
$140.80/hr for a general and operations manager, 75 hr at $64.46/hr for 
a business operations specialist, and 15 hr at $78.32/hr for a computer 
programmer) for each PAHP. In aggregate, we estimate a one-time private 
sector burden of 4,100 hr (41 PAHPs x 100 hr) and $304,109.30 [41 PAHPs 
x ((10 hr x $140.80/hr) + (75 hr x $64.46/hr) + (15 hr x $78.32/hr))]. 
We are annualizing the one-time development since we do not anticipate 
any additional burden after the 3-year approval period expires.
    We further estimate that the average PAHP only receives 10 
grievances per month due to their limited benefit package and will only 
require 3 hr at $64.46/hr for a business operations specialist to 
process and handle grievances and adverse benefit determinations. In 
aggregate, we estimate an annual private sector burden of 14,760 hr (41 
PAHPs x 10 grievances x 3 hr x 12 months) and $951,429.60 (14,760 hr x 
$64.46/hr).
    Section 438.402(b) limits MCOs, PIHPs, and PAHPs to one level of 
appeal for enrollees. This will likely eliminate a substantial amount 
of burden from those that currently have more than one, but we are 
unable to estimate that amount since we do not know how many levels 
each managed care plan currently utilizes. We requested comment from 
managed care plans to help us estimate the savings from this provision. 
We received no comments and will finalize this section with no 
estimated cost savings.
32. ICRs Regarding Timely and Adequate Notice of Adverse Benefit 
Determination (Sec.  438.404)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.404(a) adds PAHPs as an entity that must give the 
enrollee timely written notice. It also sets forth the requirements of 
that notice. Consistent with the requirements for MCOs and PIHPs, PAHPs 
must give the enrollee timely written notice if it intends to: deny, 
limit, reduce, or terminate a service; deny payment; deny the request 
of an enrollee in a rural area with one plan to go out of network to 
obtain a service; or fails to furnish, arrange, provide, or pay for a 
service in a timely manner.
    We estimate an annual private sector burden of 1 min at $30.92/hr 
for a mail clerk to send this notification. We also estimate that 2 
percent (240,000) of the 12 million PAHP enrollees will receive one 
notice of adverse benefit determination per year from a PAHP. In 
aggregate, we estimate an annual state burden of 4,000 hr (240,000 
enrollees x 1 min) and $123,927.36 (4,000 hr x $30.92/hr).
33. ICRs Regarding Resolution and Notification: Grievances and Appeals 
(Sec.  438.408)
    The following requirements and burden estimates were set out in the

[[Page 27791]]

proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.408(b) changes the time frame for appeal resolution 
from 45 days to 30 days. For MCOs, PIHPs, and PAHPs that have Medicare 
and/or QHP lines of business, this reflects a reduction in burden as 
this aligns Medicaid time frames with Medicare and QHP. For MCOs, 
PIHPs, and PAHPs that do not have Medicare and/or QHP lines of 
business, and whose state has an existing time frame longer than 30 
days, they will need to revise their policies and procedures. Of the 
568 MCOs, PIHPs, and PAHP, we assumed at least 50 percent offered 
either a Medicare or QHP product line. Of that, we then assumed that 
some plans already had 30 day timeframes. Of those plans remaining, we 
believed 200 to be a reasonable estimate. Among the 200 MCOs, PIHPs, 
and PAHPs, we estimate a one-time private sector burden of 1 hr at 
$64.46/hr for a business operations specialist. In aggregate, we 
estimate 200 hr (200 MCOs, PIHPs, and PAHPs x 1 hr) and $12,892 (200 hr 
x $64.46). We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires.
34. ICRs Regarding Recordkeeping Requirements (Sec.  438.416)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    This section adds PAHPs to the requirement to maintain records of 
grievances and appeals. We estimate that approximately 240,000 
enrollees (2 percent) of the approximately 12 million PAHP enrollees 
file a grievance or appeal with their PAHP. As the required elements 
will be stored and tracked electronically, we estimate 1 min per 
grievance and appeal at $36.54/hr for an office and administrative 
support worker to maintain each grievance and appeals record. In 
aggregate, we estimate an annual private sector burden of 4,000 hr 
(240,000 grievances x 1 min) and $146,452.32 (4,000 hr x $36.54/hr).
    Maintaining records for grievances and appeals has always been 
required for MCOs and PIHPs. However, this rule requires specific data 
so a few MCOs and PIHPs (10 percent 335 MCOs + 176 PIHPs) may have to 
revise their policies and systems to record the required information. 
We estimate 3 hr at $78.32 for a computer programmer to make necessary 
changes. We estimate a one-time private sector burden of 153 hr (51 
MCOs and PIHPs x 3 hr) and $11,982.96 (153 hr x $78.32/hr). We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. As the 
required elements will be stored and tracked electronically, we 
estimate 1 min per grievance and appeal at $36.54/hr for an office and 
administrative support worker to maintain each grievance and appeals 
record. In aggregate, we estimate an annual private sector burden of 
14,299 hr (856,257 grievances (.02 x 4,394,450 (.10 x 43,944,503 MCO 
and PIHP enrollees) x 1 min) and $522,503.43 (14,299 hr x $36.54/hr).
35. ICRs Regarding Continuation of Benefits While the MCO, PIHP, or 
PAHP Appeal and the State Fair Hearing are Pending. (Sec.  438.420)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.420(c)(4) removes the time period or service limit of a 
previously authorized service has been met as a criteria for defining 
the duration of continued benefits and adds ``PAHP'' as a conforming 
change to Sec.  438.400. This action requires that MCOs and PIHPs 
revise current policies and procedures to reflect having only 3 
criteria instead of 4. PAHPs would incorporate the options in Sec.  
438.420(c)(1) through (3) when developing their system under Sec.  
438.402 and thus the elimination of Sec.  438.420 (c)(4) would have no 
impact on PAHPs.
    For MCOs and PIHPs, we estimate a one-time private sector burden of 
4 hr at $64.46/hr for a business operations specialist to revise 
current policies and procedures. In aggregate, we estimate 2,044 hr 
(335 MCOs + 176 PIHPs x 4 hr) and $131,756.24 (2,044 hr x $64.46/hr).
    Section 438.420(d) adds PAHPs to the list of entities that can 
recover costs if the adverse determination is upheld. PAHPs are 
required to include the policies and procedures necessary to recover 
costs when developing their system under Sec.  438.402 and thus will 
not incur additional burden.
36. ICRs Regarding State Responsibilities (Sec.  438.602)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.602(a) details state responsibilities for monitoring 
MCO, PIHP, PAHP, PCCM or PCCM's compliance with Sec. Sec.  438.604, 
438.606, 438.608, 438.610, 438.230, and 438.808. As all of these 
sections are existing requirements, the only new burden is for states 
to update their policies and procedures, if necessary, to reflect 
revised regulatory text. We estimate a one-time state burden of 6 hr at 
$64.46/hr for a business operations specialist to create and/or revise 
their policies. In aggregate, we estimate 252 hr (42 states x 6 hr) and 
$16,243.92 (252 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
    Section 438.602(b) requires states to screen and enroll MCO, PIHP, 
PAHP, PCCM and PCCM entity providers in accordance with 42 CFR part 
455, subparts B and E. Given that states already comply with these 
subparts for their FFS programs, the necessary processes and procedures 
have already been implemented. Additionally, since some states require 
their managed care plan providers to enroll with FFS, the overlap that 
occurs in many states due to provider market conditions, and the 
exemption from this requirement for Medicare approved providers, we 
believe the pool of managed care providers that will have to be newly 
screened and enrolled by the states is small. We expect the MCOs, 
PIHPs, and PAHPs will need to create data files to submit new provider 
applications to the state for the screening and enrollment processes. 
As PCCMs and PCCM entities are already FFS providers, there would be no 
additional burden on them or the state. As such, we estimate a one-time 
private sector burden of 6 hr at $78.32/hr for a computer programmer to 
create the necessary programs to send provider applications/data to the 
state. We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires. In aggregate, we estimate 3,432 hr (335 MCOs + 176 PIHPs + 61 
PAHPs x 6 hr) and $268,794.24 (3,432 hr x $78.32/hr). Once created, the 
report will likely be put on a production schedule and generate no 
additional burden.
    Section 438.602(e) requires states to conduct or contract for 
audits of MCO, PIHP, and PAHP encounter and financial data once every 3 
years. As validation of encounter data is also required in Sec.  
438.818(a), we assume no additional burden. For the financial audits, 
states could use internal staff or an existing contractual resource, 
such as their actuarial firm. For internal staff,

[[Page 27792]]

we estimate an annual state burden of 20 hr at $66.38/hr for an 
accountant. In aggregate, we estimate 3,680 hr (335 MCOs + 176 PIHPs + 
41 PAHPs x 20 hr)/3) and $244,278.40 (3,680 hr x $66.38/hr).
    Section 438.602(g) requires states to post the MCO's, PIHP's, and 
PAHP's contracts, data from Sec.  438.604, and audits from Sec.  
438.602(e) on their Web site. As most of these activities will only 
occur no more frequently than annually, we estimate an annual state 
burden of 1 hr at $78.32/hr for a computer programmer to post the 
documents. In aggregate, we estimate 40 hr (40 states x 1 hr) and 
$3,132.80 (40 hr x $78.32/hr).
37. ICRs Regarding Program Integrity Requirements (Sec.  438.608)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.608(a) requires that MCOs, PIHPs, and PAHPs to have 
administrative and management arrangements or procedures which are 
designed to guard against fraud and abuse. The arrangements or 
procedures must include a compliance program as set forth under Sec.  
438.608(a)(1), provisions for reporting under Sec.  438.608(a)(2), 
provisions for notification under Sec.  438.608(a)(3), provisions for 
verification methods under Sec.  438.608(a)(4), and provisions for 
written policies under Sec.  438.608(a)(5).
    The compliance program under Sec.  438.608(a)(1), must include: 
Written policies, procedures, and standards of conduct that articulate 
the organization's commitment to comply with all applicable federal and 
state standards and requirements under the contract; the designation of 
a Compliance Officer; the establishment of a Regulatory Compliance 
Committee on the Board of Directors; effective training and education 
for the organization's management and its employees; and provisions for 
internal monitoring and a prompt and effective response to 
noncompliance with the requirements under the contract.
    While Sec.  438.608(a)(1) is an existing regulation, we expect all 
MCOs, PIHPs, and PAHPs review their policies and procedures to ensure 
that all of the above listed items are addressed. We estimate a one-
time private sector burden of 2 hr at $64.46/hr for a business 
operations specialist to review and (if necessary) revise their 
policies and procedures. In aggregate, we estimate 1,104 hr (335 MCOs + 
176 PIHPs + 41 PAHPs x 2 hr) and $71,163.84 (1,104 hr x $64.46/hr). We 
are annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. Section 
438.608(a)(2) and (3) requires the reporting of overpayments and 
enrollee fraud. As these would be done via an email from the MCO, PIHP, 
or PAHP to the state and do not occur very often, we estimate an annual 
private sector burden of 2 hr at $64.46/hr for a business operations 
specialist. In aggregate, we estimate 1,104 hr (335 MCOs + 176 PIHPs + 
41 PAHPs x 2 hr) and $71,163.84 (1,104 hr x $64.46/hr).
    Section 438.608(a)(4) requires that the MCO, PIHP, or PAHP use a 
sampling methodology to verify receipt of services. Given that this is 
already required of all states in their FFS programs, many states 
already require their MCOs, PIHPs, and PAHPs to do this. Additionally, 
many managed care plans perform this as part of usual and customary 
business practice. Therefore, we estimate only approximately 200 MCOs, 
PIHPs, or PAHPs may need to implement this as a new procedure. As this 
typically involves mailing a letter or sending an email to the 
enrollee, we estimate that 200 MCOs, PIHPs, or PAHPs will mail to 100 
enrollees each. We estimate an annual private sector burden of 1 min at 
$30.92/hr for a mail clerk to send each letter. In aggregate, we 
estimate 333 hr (20,000 letters x 1 min/letter) and $10,327.28 (333 hr 
x $30.92/hr). This estimate will be significantly reduced as the use of 
email increases.
    Section 438.608(b) reiterates the requirement in Sec.  438.602(b) 
whereby the burden is stated in section V.C.36. of this final rule.
    Section 438.608(c) and (d) requires that states include in all MCO, 
PIHP, and PAHP contracts, the process for the disclosure and treatment 
of certain types of recoveries and reporting of such activity. While 
the burden to amend the contracts is included in Sec.  438.3, we 
estimate a one-time private sector burden of 1 hr at $78.32/hr for a 
computer programmer to create the report. In aggregate, we estimate 552 
hr (335 MCOs + 176 PIHPs + 41 PAHPs x 1 hr) and $43,232.64 (552 hr x 
$78.32/hr). Once developed, the report will be put on a production 
schedule and add no additional burden.
38. ICRs Regarding Disenrollment During Termination Hearing Process 
(Sec.  438.722)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    After a state has notified an MCO, PIHP, PAHP or PCCM of its 
intention to terminate its contract, Sec.  438.722(a) provides that the 
state may give the entity's enrollees written notice of the state's 
intent to terminate its contract. States already have the authority to 
terminate contracts according to state law and some have previously 
already opted to provide written notice to MCO and PCCM enrollees when 
exercising this authority.
    We estimate that no more than 12 states may terminate 1 contract 
per year. We also estimate an annual state burden of 1 hr at $64.46/hr 
for a business operations specialist to prepare the notice. In 
aggregate, we estimate a one-time state burden of 12 hr (12 states x 1 
hr) and $773.52 (12 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
    To send the notice, we estimate 1 min (per beneficiary) at $30.92/
hr for a mail clerk. We estimate an aggregate annual state burden of 
18,075 hr (12 states x 90,378 enrollees/60 mins per hour) and 
$560,015.35 (18,075 hr x $30.92/hr).
39. ICRs Regarding Enrollee Encounter Data (Sec.  438.818)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 438.818(a)(2) requires that the encounter data be validated 
prior to its submission. States can perform this validation activity 
themselves, contract it to a vendor, or contract it to their EQRO. In 
this regard, a state already using EQRO to validate its data at an 
appropriate frequency will incur no additional burden. Since 
approximately 10 states already use their EQRO to validate their data, 
only 27 states that use a MCO and/or PIHP may need to take action to 
meet this requirement. The method selected by the state will determine 
the amount of burden incurred. We assume an equal distribution of 
states selecting each method, thus 9 states per method.
    A state using EQRO to validate data on less than an appropriate 
frequency may need to amend their EQRO contract. In this case, we 
estimate 1 hr at $64.46/hr for a business operations specialist. In 
aggregate, we estimate a one-time state burden of 9 hr (9 states x 1 
hr) and $580.14 (9 hr x $64.46/hr). We are annualizing the one-time

[[Page 27793]]

development since we do not anticipate any additional burden after the 
3-year approval period expires.
    A state electing to perform validation internally needs to develop 
processes and policies to support implementation. In this case, we 
estimate 10 hr at $64.46/hr for a business operations specialist to 
develop policy and 100 hr at $78.32/hr for a computer programmer to 
develop, test, and automate the validation processes. In aggregate, we 
estimate a one-time state burden of 990 hr (9 states x 110 hr) and 
$76,289.40 [9 states x((10 hr x $64.46/hr) + (100 hr x $78.32hr))].
    For a state electing to procure a vendor, given the wide variance 
in state procurement processes, our burden is conservatively estimated 
at 150 hr for writing a proposal request, evaluating proposals, and 
implementing the selected proposal. We estimate 125 hr at $64.46/hr for 
a business operations specialist to participate in the writing, 
evaluating, and implementing, and 25 hr at $140.80/hr for a general and 
operations manager to participate in the writing, evaluating, and 
implementing. In aggregate, we estimate an annual state burden of 1,350 
hr [9 states x (150 hr)] and $104,197.50 [9 states x ((125 hr x $64.46/
hr) + (25 hr x $140.80/hr))].
    CHIP Information Collection Requirements (ICRs): We have updated 
enrollment estimates based on updated information obtained from the 
Statistical Enrollment Data System (SEDS) from December 2015. 
Additionally, we revised our estimate that there are 62 plans that 
states use to contract with CHIP separately from their Medicaid 
programs as a result of discussions with states since the publication 
of the NPRM. As of December 2015, there are 25 states with 
approximately 2.3 million children enrolled in managed care in separate 
CHIP programs. CMS estimates that there are 62 entities that contract 
with CHIP separately from their Medicaid contracts, including 
approximately 55 MCOs and PIHPs, 3 PAHPs, and 4 PCCMs. Wage data has 
been updated to reflect data from the U.S. Bureau of Labor Statistics' 
May 2014 National Occupational Employment and Wage Estimates for all 
salary estimates (www.bls.gov/oes/current/oes_nat.htm).
40. ICRs Regarding Standard Contract Requirements (Sec. Sec.  457.1201, 
457.1205, 457.1207, 457.1208, 457.1210, 457.1212, 457.1218, 457.1220, 
457.1222, 457.1224, 457.1226, 457.1228, 457.1230, 457.1233, 457.1240, 
457.1250, 457.1260, 457.1270, and 457.1285)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with the following changes: As 
stated above, we have updated the projected enrollment of children in 
managed care in CHIP (to approximately 2.3 million children) with 
updated enrollment numbers obtained from the SEDS, as well as updated 
the number of states and plans with managed care upon further 
information gathering from states (to 62 entities that contract with 
CHIP separately from their Medicaid contracts, including approximately 
55 MCOs and PIHPs, 3 PAHPs, and 4 PCCMs). We have also made minor 
adjustments to the hourly rates. No comments were received. Section 
457.1201 contains a list of standard requirements that must be included 
in MCO, PIHP, PAHP, and PCCM contracts. The following burden estimate 
addresses the effort to amend such contracts in addition to the 
contract amendments associated with Sec. Sec.  457.1203, 457.1207, 
457.1208, 457.1209, 457.1210, 457.1212, 457.1218, 457.1220, 457.1222, 
457.1224, 457.1226, 457.1228, 457.1230, 457.1233, 457.1240, 457.1250, 
457.1260, 457.1270, and 457.1285. We estimate a one-time state burden 
of 6 hr at $64.46/hr for a business operations specialist to amend all 
contracts associated with the aforementioned requirements. In 
aggregate, we estimate 372 hr (62 contracts x 6 hr) and $23,979.12 (372 
hr x $64.46/hr). We are annualizing the one-time development since we 
do not anticipate any additional burden after the 3-year approval 
period expires.
41. ICRs Regarding Rate Development Standards and Medical Loss Ratio 
(Sec.  457.1203 (and Former Sec.  457.1205))
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to account for 
the number of contracts and to provide for minor adjustments to hourly 
rates. No comments were received.
    Section 457.1203 (which has been modified in this final rule to 
include the requirements proposed at Sec.  457.1205) applies the 
requirements of Sec.  438.8 to CHIP. Section 438.8(c) requires that 
MCOs, PIHPs, and PAHPs report to the state annually their total 
expenditures on all claims and non-claims related activities, premium 
revenue, the calculated MLR, and, if applicable under other authority, 
any remittance owed.
    We estimate the total number of MLR reports that MCOs, PIHPs, and 
PAHPs will be required to submit to the state will amount to 58 
reports. We estimate a one-time burden of 168 hr for the initial 
administration activities. In the first year, we estimate that 60 
percent of the time will be completed by a computer programmer (101 hr 
at $78.32/hr), 30 percent will be completed by a business operations 
specialist (50 hr at $64.46/hr), and 10 percent will be completed by a 
general and operations manager (17 hr at $140.80/hr). The first year 
burden amounts to 168 hr and $13,526.92 ((101 hr x $78.32) + (50 hr x 
$64.46) + (17 hr x $140.80)) per report or, in aggregate, 9,744 hr (58 
reports x 168 hr) and $784,561.36 (58 x $13,526.92).
    In subsequent years, since the programming and processes 
established in year 1 will continue to be used, the burden will be 
decrease from 168 hr to an ongoing burden of approximately 53 hr. Using 
the same proportions of labor allotment, we estimate 53 hr and 
$4,261.73 ((31.8 hr x $78.32) + (15.9 hr x $64.46) + (5.3 hr x 
$140.80)) per report and a total of 3,074 hr (53 hr x 58 reports) and 
$247,180.34 (58 reports x $4,261.73). We expect states to permit MCOs 
and PIHPs to submit the report electronically. Since the submission 
time is included in our reporting estimate, we are not setting out the 
burden for submitting the report.
42. ICRs Regarding Non-emergency Medical Transportation PAHPs (Sec.  
457.1206)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change except for the minor 
adjustments to hourly rates. No comments were received.
    Section 457.1206 provides a list of standard requirements that must 
be included in NEMT PAHP contracts. The following burden estimate 
addresses the effort to amend such contracts in addition to the 
contract amendments associated with Sec. Sec.  457.1203, 457.1207, 
457.1208, 457.1209, 457.1212, 457.1214, 457.1216, 457.1220, 457.1222, 
457.1224, 457.1226, 457.1230, and 457.1233. We estimate a one-time 
state burden of 4 hr at $64.46/hr for a business operations specialist 
to amend all contracts associated with the aforementioned requirements. 
In aggregate, we estimate 12 hr (3 contracts x 4 hr) and $773.52 (12 hr 
x $64.46/hr). We are annualizing the one-time development since we do 
not anticipate any additional burden after the 3-year approval period 
expires.
43. ICRs Regarding Information Requirements (Sec.  457.1207)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with the minor adjustments to 
hourly rates and a lower estimate as to the number of states affected 
by this

[[Page 27794]]

provision as we have reviewed information from the SEDS since the 
publication of the proposed rule and reduced the estimate as a result. 
No comments were received.
    Section 457.1207 applies the requirements of Sec.  438.10 to CHIP. 
Section 438.10(c)(1) requires that states with separate CHIPs with 
managed care (25) to provide enrollment notices, informational 
materials, and instructional materials in an easily understood format. 
We anticipate that most states already do this and will only have to 
make minor revisions. We estimate an annual burden of 4 hr at $64.46/hr 
for a business operations specialist to make these revisions. In 
aggregate, we estimate 100 hr (25 states x 4 hr) and $6,446 (100 hr x 
$64.46/hr).
    Section 438.10(c)(3) requires that states operate a Web site which 
provides the information set out under Sec.  438.10(f). Since all 
states already have Web sites for their Medicaid programs and most also 
include information about their managed care program, most states will 
probably only have to make minor revisions to their existing Web site. 
We estimate a one-time state burden of 6 hr at $78.32/hr for a computer 
programmer to make the initial changes. In aggregate, we estimate 150 
hr (25 states x 6 hr) and $11,748 (150 hr x $78.32/hr). We also 
estimate an annual burden of 3 hr at $78.32/hr for a computer 
programmer to periodically add or update documents and links on the Web 
site. In aggregate, we estimate 75 hr (25 states x 3 hr) and $5,874 (75 
hr x $78.32/hr).
    Section 438.10(c)(4)(i) recommends that states develop definitions 
for commonly used terms to enhance consistency of the information 
provided to enrollees. We estimate a one-time state burden of 6 hr at 
$64.46/hr for a business operations specialist to develop these 
definitions. In aggregate, we estimate 150 hr (25 states x 6 hr) and 
$9,669 (150 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
    Section 438.10(c)(4)(ii) recommends that states create model 
enrollee handbooks and notices. Since many states already provide model 
handbooks and notices to their entities, we estimate that 15 states may 
need to take action to comply with this provision. We estimate a one-
time state burden of 40 hr at $64.46/hr for a business operations 
specialist to create these documents. In aggregate, we estimate 600 hr 
(15 states x 40 hr) and $38,676.00 (600 hr x $64.46/hr). We also 
estimate an annual state burden of 2 hr at $64.46/hr for a business 
operations specialist to maintain these documents. In aggregate, we 
estimate 30 hr (15 states x 2 hr) and $1,933.80 (30 hr x $64.46/hr).
    Section 438.10(d)(1) requires that states identify prevalent non-
English languages spoken in each managed care entity's service area. 
Given that states must already determine the prevalent non-English 
languages spoken in their entire Medicaid service area based on the 
policy guidance ``Enforcement of Title VI of the Civil Rights Act of 
1964--National Origin Discrimination Against Persons With Limited 
English Proficiency'' from the U.S. Department of Justice, we believe 
that dividing the information by plan service area requires only 
minimal IT programming. More specifically, we estimate a one-time state 
burden of 4 hr at $78.32/hr for a computer programmer to create these 
reports. We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires. In aggregate, we estimate 100 hr (25 states x 4 hr) and $7,832 
(100 hr x $78.32/hr) to create these reports. We estimate no additional 
burden for the running of these reports as they will be put into a 
production schedule, and putting a report into production adds no 
additional burden.
    Section 438.10(d)(2)(i) requires that states add taglines to all 
printed materials for potential enrollees explaining the availability 
of translation and interpreter services as well as the phone number for 
choice counseling assistance. We estimate a one-time state burden of 2 
hr at $64.46/hr for a business operations specialist to create the 
taglines and another 4 hr to revise all document originals. In 
aggregate, we estimate 150 hr (25 states x 6 hr) and $9,669 (150 hr x 
$64.46/hr). As the prevalent languages within a state do not change 
frequently, we are not estimating burden for the rare updates that will 
be needed to these taglines.
    Section 438.10(e)(1) clarifies that states can provide required 
information in paper or electronic format. As the amount and type of 
information that can be provided electronically will vary greatly among 
the states due to enrollee access and knowledge of electronic 
communication methods, it is not possible to estimate with any accuracy 
the amount that will be able to be converted from written to electronic 
format. Therefore, we will use estimates for all written materials 
knowing that some of this burden will be alleviated as the states are 
gradually able to convert to electronic communication methods. In this 
regard, we estimate a one-time state burden of 40 hr at $64.46/hr for a 
business operations specialist to create the materials. We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. Many states 
already provide similar information to potential enrollees, so we 
anticipate that only 15 states will need to create these materials. We 
also estimate 1 min at $36.54/hr for an office and administrative 
support worker to mail the materials annually. For existing states, we 
estimate 1 hr at $64.46/hr for a business operations specialist to 
update or revise existing materials and 1 min at $36.54/hr for an 
office and administrative support worker to mail the materials to 5 
percent of the enrollees that are new (115,000 enrollees). In 
aggregate, we estimate a one-time state burden of 600 hr (15 states x 
40 hr) and $38,676.00 (600 hr x $64.46/hr) to create materials. We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. We estimate 
a one-time state burden of 25 hr (25 states x 1 hr) and $1,611.50 (25 
hr x $64.46/hr) to update or revise existing materials. We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. The state 
will also need to mail the materials. We estimate an ongoing burden of 
1,916.67 hr (115,000 enrollees x 1 min) and $59,263.44 (1,916.67 hr x 
$36.54/hr) to mail materials.
    Although Sec.  438.10(g)(1) and (2) require the provision of an 
enrollee handbook, Medicaid regulations have always required the 
provision of this information (although it did not specifically call it 
a ``handbook'') so we do not anticipate that all entities will need to 
create a new handbook. Additionally, given the requirement in Sec.  
438.10(c)(4)(ii) (which is adopted in CHIP through Sec.  457.1207) for 
the state to provide a model template for the handbook, the burden on 
an entity is greatly reduced. We estimate approximately 5 new managed 
care entities per year using 10 hr at $64.46/hr for a business 
operations specialist to create a handbook using their state's model 
template. In aggregate, we estimate 50 hr (5 entities x 10 hr) and 
$3,223.00 (50 hr x $64.46/hr). For existing MCOs, PIHPs, PAHPs, and 
PCCMs that already have a method for distributing the information, we 
believe that 20 entities will need to modify their existing handbook to 
comply with a new model provided by the state. We also estimate a one-
time private sector burden of 4 hr at $64.46/hr for a business 
operations specialist to update

[[Page 27795]]

their entity's handbook. Once revised, we estimate 1 min at $36.54/hr 
for an office and administrative support worker to send these handbooks 
to 1,150,000 enrollees (50 percent of total enrollment). In aggregate, 
we estimate 80 hr (20 entities x 4 hr) and $5,156.80 (80 hr x $64.46/
hr) to update handbooks. To send the updated handbooks, we estimate 
19,166.67 hr (1,150,000 enrollees x 1 min) and $698,523.12 (19,166.67 
hr x $36.54/hr).
    All new enrollees must receive a handbook within a reasonable time 
after receiving notice of the beneficiary's enrollment. We assume a 5 
percent enrollee growth rate thus 115,000 enrollees (5 percent of 
2,300,000) will need to receive a handbook each year. (Existing 
enrollees typically do not receive a new handbook annually unless 
significant changes have occurred so this estimate is for new 
beneficiaries only.) We estimate a private sector state burden of 1 min 
at $36.54/hr for an office and administrative support worker to mail 
the handbook. In aggregate, we estimate 1,916.67 hr (115,000 enrollees 
x 1 min) and $70,035.12 (1,916.67 hr x $36.54/hr) to send handbooks to 
new enrollees.
    All entities will need to keep their handbook up to date. In this 
regard, we estimate an annual private sector burden of 1 hr at $64.46/
hr for a business operations specialist to update the handbook. While 
the updates need to be made as program changes occur, we estimate 1 hr 
since each change may only take a few minutes to make. In aggregate, we 
estimate 62 hr (62 entities x 1 hr) and $3,996.52 (62 hr x $64.46/hr).
    Section 438.10(h) requires that MCOs, PIHPs, PAHPs, and PCCMs make 
a provider directory available in paper or electronic form. Producing a 
provider directory is a longstanding Medicaid requirement in Sec.  
438.10, as well in the private health insurance market. Additionally, 
given the time sensitive nature of provider information and the 
notorious high error rate in printed directories, most provider 
information is now obtained via Web site or by calling the customer 
service unit. Thus, the only new burden estimated is the time for a 
computer programmer to add a few additional fields of data as 
appropriate, specifically, provider Web site addresses, additional 
disability accommodations, and adding behavioral and long-term services 
and support providers. We estimate a one-time private sector burden of 
1 hr at $78.32/hr for a computer programmer to update the existing 
directory. In aggregate, we estimate 62 hr (62 entities x 1 hr) and 
$4,855.84 (62 hr x $78.32/hr). Updates after creation of the original 
program will be put on a production schedule, which generates no 
additional burden.
44. ICRs Regarding Requirements That Apply to MCO, PIHP, PAHP, and PCCM 
Contracts Involving Indians, Indian Health Care Providers, and Indian 
Managed Care Entities (Sec.  457.1209)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with revisions to reduce the 
estimate of states affected, as well as minor revisions to reflect 
updated wage data. No comments were received.
    Section 457.1209 (incorrectly listed as Sec.  457.1208 in the 
proposed rule) applies the requirements of Sec.  438.14 to CHIP. 
Section 438.14(c) requires states to make supplemental payments to 
Indian providers if the managed care entity does not pay at least the 
amount paid to Indian providers under the FFS program. There are 
approximately 18 states with separate CHIPs that have federally 
recognized tribes. We do not know how many managed care entities have 
Indian providers, but estimate that it is approximately 40 entities. 
This type of payment arrangement typically involves the managed care 
entity sending a report to the state, which then calculates and pays 
the amount owed to the Indian health care provider. We estimate it will 
take 1 hr at $78.32/hr for a computer programmer to create the claims 
report and approximately 12 hr at $64.46/hr for a state business 
operations specialist to process the payments. We estimate that 
approximately 18 states will need to use this type of arrangement. In 
aggregate, we estimate a one-time private sector burden of 40 hr (40 
entities x 1 hr) and $3,132.80 (40 hr x $78.32/hr). We are annualizing 
the one-time development since we do not anticipate any additional 
burden after the 3-year approval period expires. We also estimate an 
ongoing state burden of 216 hr (18 states x 12 hr) and $13,923.36 (216 
hr x $64.46/hr).
    After the MCO, PIHP, PAHP, and PCCM report is created, it will most 
likely run automatically at designated times and sent electronically to 
the state as the normal course of business operations; therefore, no 
additional burden is estimated after the first year.
    (Note: This process is not necessary when the MCO, PIHP, PAHP, or 
PCCM entity pays the IHCP at least the full amount owed under this 
regulation.)
45. ICRs Regarding Managed Care Enrollment (Sec.  457.1210)
    This burden estimate has been revised because of the additions to 
the regulation in Sec.  457.1210(c), which are discussed in section 
II.B.9.
    Section 457.1210(a) requires states to establish a process for 
prioritizing individuals for enrollment into managed care plans. 
Establishing a default enrollment process requires policy changes and 
require the state to send notices to enrollees once they have been 
enrolled in a plan. We estimate that states will need to use the 
default enrollment process specified in Sec.  457.1210(a) for 5 percent 
of enrollees (115,000), and that it will take 1 min at $36.54/hr for an 
office and administrative support worker to send the notice. In 
aggregate, we estimate 1,916.67 hr (115,000 beneficiaries x 1 min) and 
$70,035.12 (1,916.67 hr x $36.54/hr) to send the notices.
    Section 457.1210(c) requires states to send a notice to potential 
enrollees. We believe some states already send such notices, so that 
only 15 states will have to develop new notices. We estimate that it 
will take 4 hr at $64.46/hr for a business operations specialist to 
create the notice. We estimate a one-time burden of 60 hr (4 hr x 15 
states) and $3,867.60 (60 hr x $64.46) to develop the notice. We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires.
    In addition, we estimate that states would need to send notices to 
5 percent of enrollees (115,000) who would be new to managed care each 
year. We estimate it would take 1 min/enrollee 1 min at $36.54/hr for 
an office and administrative support worker to mail each notice. We 
estimate a total annual burden of 1,916.67 hr (115,000 beneficiaries x 
1 min) and $70,035.12 (1,916.67 hr x $36.54/hr) to send the notices.
46. ICRs Regarding Disenrollment (Sec.  457.1212)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to reflect 
updated wage data. No comments were received.
    Section 457.1212 applies the requirements of Sec.  438.56 to CHIP. 
To disenroll, Sec.  438.56(d)(1) requires that the beneficiary (or his 
or her representative) submit an oral or written request to the state 
agency (or its agent) or to the MCO, PIHP, PAHP, or PCCM, where 
permitted. We estimate that 5 percent of MCO, PIHP, PAHP, and PCCM 
enrollees will request that they be disenrolled from an MCO, PIHP, 
PAHP, or PCCM each year. We also estimate approximately one-fourth of 
the enrollees will choose a written rather than an oral request.

[[Page 27796]]

    We estimate an ongoing burden of 10 min for an enrollee to generate 
a written disenrollment request and 3 min per oral request. In 
aggregate, we estimate an annual burden (written requests) of 4,791.67 
hr (28,750 enrollees x 10 min) and 4,312.5 hr (86,250 enrollees x 3 
min) for oral requests.
47. ICRs Regarding Conflict of Interest Safeguards (Sec.  457.1214)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to reflect 
updated wage data. No comments were received.
    Section 457.1214 applies the requirements of Sec.  438.58 to CHIP. 
Section 438.58 requires that states have in place safeguards against 
conflict of interest for employees or agents of the state who have 
responsibilities relating to the MCO, PIHP, or PAHP. We anticipate that 
most states already have such safeguards in place, and only 5 states 
will need to develop new standards to comply with this provision. We 
estimate a one-time state burden of 10 hr at $64.46/hr for a business 
operations specialist to develop those standards. In aggregate, we 
estimate 50 hr (5 states x 10 hr) and $3,223.00 (50 hr x $64.46/hr). We 
are annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires.
48. ICRs Regarding Continued Services to Beneficiaries (Sec.  457.1216)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with revisions to reduce the 
estimate of states affected, as well as minor revisions to reflect 
updated wage data. No comments were received.
    Section 457.1216 applies the requirements of Sec.  438.62 to CHIP. 
Section 438.62(b)(1) requires that states have a transition of care 
policy for all beneficiaries moving from FFS CHIP into a MCO, PIHP, 
PAHP or PCCM, or when an enrollee is moving from one MCO, PIHP, PAHP, 
or PCCM to another and that enrollee would experience a serious 
detriment to health or be at risk of hospitalization or 
institutionalization without continued access to services. We estimate 
a one-time state burden of 10 hr at $64.46/hr for a business operations 
specialist to develop the transition of care policy. In aggregate, we 
estimate 250 hr (25 states x 10 hr) and $16,115 (250 hr x $64.46/hr). 
We are annualizing the one-time development since we do not anticipate 
any additional burden after the 3-year approval period expires.
    Section 438.62(b)(2) requires that MCOs, PIHPs, PAHPs, or PCCMs 
implement their own transition of care policy that meets the 
requirements of Sec.  438.62(b)(1). We estimate it will take 4 hr at 
$78.32/hr for a computer programmer to create the program that gathers 
and sends the FFS data to the MCOs, PIHPs, PAHPs, or PCCMs. We also 
estimate each MCO, PIHP, PAHP, or PCCM will use 4 hr of a computer 
programmer time to create programs to receive and store data as well as 
gather and send data to other plans. We are not estimating additional 
ongoing burden for the routine running of these reports as they will be 
put into a production schedule. In aggregate, we estimate a one-time 
state burden of 100 hr (25 states x 4 hr) and $7,832 (100 hr x $78.32/
hr) to create the program that gathers and sends the FFS data to the 
MCOs, PIHPs, PAHPs, or PCCMs. We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires. We also estimate a one-time private 
sector burden of 248 hr (62 MCOs, PIHPs, PAHPs, or PCCMs x 4 hr) and 
$19,423.36 (248 hr x $78.32/hr) to create programs to receive and store 
data as well as gather and send data to other plans. We are annualizing 
the one-time development since we do not anticipate any additional 
burden after the 3-year approval period expires.
    Once a MCO, PIHP, PAHP, or PCCM receives a request or identifies a 
need to arrange for the transition of services, we estimate a 
registered nurse at the managed care plan may need 10 min, on average, 
to access the stored information and take appropriate action. We 
believe that an average of 25,000 beneficiaries will transition into 
managed care each year from FFS and 5,000 may switch between plans that 
meet the state defined standards to qualify for the transition of care 
policy. In aggregate, we estimate an annual for private sector burden 
of 5,000 hr (30,000 beneficiaries x 10 min) and $334,600.00 (5,000 hr x 
$66.92/hr).
49. ICRs Regarding Network Adequacy Standards (Sec.  457.1218)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to reflect 
updated wage data. No comments were received.
    Section 457.1218 applies the requirements of Sec.  438.68 to CHIP. 
Section 438.68(a) requires that states set network adequacy standards 
that each MCO, PIHP and PAHP must follow. Section 438.68(b) and (c) 
require that states set standards that must include time and distance 
standards for specific provider types and network standards for LTSS 
(if the MCO, PIHP or PAHP has those benefits covered through their 
contract).
    We believe some states already comply with these requirements and 
that only 12 states will need to develop the standards. We estimate a 
one-time first year burden of 15 hr at $64.46/hr for a business 
operations specialist to develop network standards meeting the specific 
provider types found in Sec.  438.68(b)(1). In aggregate, we estimate 
180 hr (12 states x 15 hr) and $11,602.80 (180 hr x 64.46/hr). We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires.
    Very few states include LTSS in CHIP, therefore we estimate only 5 
states will need to develop related standards. We estimate a one-time 
burden of 10 additional hr at $64.46/hr for a business operations 
specialist to develop those standards. In aggregate, we estimate 50 hr 
(5 states x 10 hr) and $3,223.00 (50 hr x $64.46/hr) for the 
development of LTSS standards. After network standards are established, 
we estimate that the maintenance of the network standards will be part 
of usual and customary business practices and therefore, we do not 
estimate any burden for states after the first year.
    Section 438.68(d) requires that states: (1) Develop an exceptions 
process for plans unable to meet the state's standards; and (2) review 
network performance for any MCO, PIHP or PAHP to which the state 
provides an exception. We estimate a one-time state burden of 3 hr at 
$64.46/hr for a business operations specialist to establish an 
exceptions process. In aggregate, we estimate 75 hr (25 states x 3 hr) 
and $4,834.50 (75 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
    The exception process should not be used very often as MCOs, PIHPs, 
and PAHPs meeting the established standards is critical to enrollee 
access to care. As such, after the exceptions process is established, 
we estimate that the occasional use of it will not generate any 
measurable burden after the first year.
50. ICRs Regarding Enrollee Rights (Sec.  457.1220)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to reflect 
updated wage data. No comments were received.

[[Page 27797]]

    Section 457.1220 applies the requirements of Sec.  438.100 to CHIP. 
We do not anticipate a burden associated with implementing this section 
because the requirements to provide enrollees with treatment options 
and alternatives, allow enrollees to participate in decisions regarding 
health care, ensure that enrollees are free from restraint or 
seclusion, are standard practice in the field. The burden associated 
with providing information in accordance with 45 CFR 164.524 and 
164.526 is accounted for in the collection of information associated 
with those regulations. The burden associated with modifying contracts 
to comply with this regulation are accounted for under Sec.  457.1202.
51. ICRs Regarding Provider-Enrollee Communication (Sec.  457.1222)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to update the 
wage data. No comments were received.
    Section 457.1222 applies the requirements of Sec.  438.102 to CHIP. 
Section 438.102(a)(2) provides that MCOs, PIHPs, and PAHPs are not 
required to cover, furnish, or pay for a particular counseling or 
referral service if the MCO, PIHP, or PAHP objects to the provision of 
that service on moral or religious grounds and that written information 
on these policies is available to: (1) Prospective enrollees, before 
and during enrollment; and (2) current enrollees, within 90 days after 
adopting the policy for any particular service.
    We believe the burden for providing written notice to current 
enrollees within 90 days of adopting the policy for a specific service, 
will affect no more than 3 MCOs or PIHPs annually since it will apply 
only to the services they discontinue providing on moral or religious 
grounds during the contract period. PAHPs are excluded from this 
estimate because they generally do not provide services that are 
affected by this provision.
    We estimate that each of the 3 MCOs or PIHPs will have such a 
policy change only once annually. We estimate that it will take 1 hr at 
$64.46/hr for a business operations analyst to update the policies. In 
aggregate, we estimate 3 hr (3 MCOs/PIHPs x 1 hr) and $193.38 (3 hr x 
$64.46/hr). We further estimate that it will take 4 hr at $64.46/hr for 
a business operations specialist to create the notice and 1 min at 
$36.54/hr for an office and administrative support worker to mail each 
notice. With an average MCO/PIHP enrollment of 78,000 enrollees, we 
estimate a total annual burden of 12 hr (3 MCOs/PIHPs x 4 hr/notice) 
and $773.52 (12 hr x $64.46/hr) to create the notice. To mail the 
notice we estimate 3,900 hr (3 MCOs/PIHPs x 78,000 enrollees x 1 min/
notice) and $142,506.00 (3,900 hr x $36.54/hr).
52. ICRs Regarding Marketing Activities (Sec.  457.1224)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to update the 
wage data. No comments were received.
    Section 457.1224 applies the requirements of Sec.  438.104 to CHIP. 
Section 438.104(c) requires that the state review marketing materials 
submitted by managed care entities. We believe that each entity will 
revise its materials once every 3 years. We estimate a state burden of 
3 hr at $64.46/hr for a business operations specialist to review an 
entity's materials. In aggregate, we estimate an annual state burden of 
75 hr [3 hr x 25 entities (one third of the total entities)] and 
$4,834.50 (75 hr x $64.46/hr).
    We estimate that 5 entities may need to revise and submit updated 
materials. We estimate a private sector burden of 2 hr at $64.46/hr for 
a business operations specialist to update and submit the materials. In 
aggregate, we estimate a one-time burden of 10 hr (5 entities x 2 hr) 
and $644.60 (10 hr x $64.46).
53. ICRs Regarding Access Standards (Sec.  457.1230)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with revisions to the wage data and 
updated estimates on the number of plans. No comments were received.
    Section 457.1230 applies the requirements of Sec. Sec.  438.206, 
438.207, 438.208, and 438.210 to CHIP. Section 438.206(c)(3), adopted 
in CHIP through Sec.  457.1230(a), requires that MCOs, PIHPs, and PAHPs 
ensure that providers assure access, accommodations, and equipment for 
enrollees with physical and/or mental disabilities. We believe that 
MCOs, PIHPs, and PAHPs will need to review and revise (possibly) their 
policies and procedures for network management to ensure compliance 
with this requirement.
    We estimate a one-time private sector burden of 3 hr at $64.46/hr 
for a business operations specialist to review and revise their network 
management policies and procedures. In aggregate, we estimate 174 hr 
(58 MCO/PIHP/PAHPs x 3 hr) and $11,216.04 (174 hr x $64.46/hr). We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires.
    Section 438.207(b), adopted in CHIP through Sec.  457.1230(b) would 
require that each MCO, PIHP, and PAHP (where applicable) submit 
documentation to the state, in a format specified by the state, to 
demonstrate that it: (1) Complies with specified requirements, and (2) 
has the capacity to serve the expected enrollment in its service area 
in accordance with the state's standards for access to care. Section 
438.207(c) would require that the documentation be submitted to the 
state at least annually, at the time the MCO, PIHP, or PAHP enters into 
a contract with the state, and at any time there has been a significant 
change (as defined both by the state) in the MCO, PIHP, or PAHP's 
operations that would affect adequate capacity and services.
    We estimate an annual private sector burden of 20 hr at $64.46/hr 
for a business operations specialist to compile the information 
necessary to meet this requirement. In aggregate, we estimate 1,160 hr 
(58 entities x 20 hr) and $74,773.60 (1,160 hr x $64.46/hr).
    After reviewing the documentation, Sec.  438.207(d), adopted in 
CHIP through Sec.  457.1230(b), would require that the state certify 
(to CMS) that the entity has complied with the state's requirements 
regarding the availability of services, as set forth at Sec.  438.68. 
We estimate an annual state burden of 1 hr/contract at $64.46/hr for a 
business operations specialist to review documentation and submit the 
certification to CMS. In aggregate, we estimate 58 hr (58 entities x 1 
hr) and $3,738.68 (59 hr x $64.46/hr).
    Section 438.208(b)(2)(iii) through Sec.  457.1230(c), requires that 
MCOs, PIHPs and PAHPs coordinate service delivery with the services the 
enrollee receives in the FFS program (carved out services). This would 
involve using data from the state to perform the needed coordination 
activities. Since only a small percentage of enrollees receive carved 
out services and need assistance with coordination, we estimate 2 
percent of all MCO, PIHP, and PAHP enrollees (64,000) will be affected.
    We estimate an annual private sector burden of 10 min/enrollee at 
$51.54/hr for a healthcare social worker. In aggregate, we estimate 
10,666 hr (64,000 enrollees x 10 min) and $589,440 (10,666 hr x $55.26/
hr).
    Section 438.208(b)(3), adopted in CHIP through Sec.  457.1230(c), 
would require that an MCO, PIHP or PAHP make its best effort to conduct 
an initial assessment of each new enrollee's needs within 90 days of 
the enrollment. We believe that most MCOs and PIHPs

[[Page 27798]]

already meet this requirement and only 25 percent of the MCOs and PIHPs 
(14) would need to alter their processes; however, we do not believe 
this to be as common a practice among PAHPs and assume that all 3 PAHPs 
will be need to add this assessment to their initial enrollment 
functions. We estimate a one-time private sector burden of 3 hr at 
$64.46/hr for a business operations specialist to revise their policies 
and procedures. In aggregate, we estimate 51 hr [(14 MCOs and PIHPs + 3 
PAHPs) x 3 hr] and $3,287.46 (51 hr x $64.46/hr). We are annualizing 
the one-time development since we do not anticipate any additional 
burden after the 3-year approval period expires.
    We estimate that in a given year, approximately 10 percent of all 
enrollees are new to a managed care plan. Thus, 230,000 enrollees would 
be considered new and in need of an initial assessment. As PAHPs are 
typically a single entity within the state, we estimate that only 5 
percent of their enrollees (10,000 enrollees) would need an initial 
assessment. In general, we believe these assessments will take 10 min 
on average to complete by Call Center staff at $36.54/hr. In aggregate, 
we estimate an annual private sector burden of 38,333 hr (230,000 
enrollees x 10 min) and $1,400,700 (38,333 hr x $36.54/hr).
    Section 438.208(b)(4), adopted in CHIP through Sec.  457.1230(c), 
requires that MCOs, PIHPs, and PAHPs share with other MCOs, PIHPs, and 
PAHPs serving the enrollee the results of its identification and 
assessment of any enrollee with special health care needs so that those 
activities need not be duplicated. The burden associated with this 
requirement is the time it takes each MCO, PIHP or PAHP to disclose 
information on enrollees with special health care needs to the MCO, 
PIHP or PAHP providing a carved out service. This would most likely be 
accomplished by developing a report to collect the data and sending 
that report to the other MCO, PIHP, or PAHP.
    We estimate a one-time private sector burden of 4 hr at $78.32/hr 
for a computer programmer to develop the report. In aggregate, we 
estimate of 232 hr (58 MCOs, PIHP, and PAHPs x 4 hr) and $18,170.24 
(232 hr x $78.32/hr). We are annualizing the one-time development since 
we do not anticipate any additional burden after the 3-year approval 
period expires. Once put into production on a schedule, no additional 
staff time would be needed, thus no additional burden is estimated.
    Section 438.208(c)(2) and (3), adopted in CHIP through Sec.  
457.1230(c), requires that the MCOs, PIHPs and PAHPs complete a 
comprehensive assessment and treatment plan for all enrollees that have 
special health care needs. The assessments and treatment plans should 
be completed by providers or MCO, PIHP or PAHP staff that meet the 
qualifications specified by the state. We believe the burden associated 
with this requirement is the time it takes to gather the information 
during the assessment. (Treatment plans are generally developed while 
the assessment occurs so we are not estimating any additional time 
beyond the time of the assessment.) We believe that only enrollees in 
MCOs and PIHPs will require this level of assessment as most PAHPs 
provide limited benefit packages that do not typically warrant a 
separate treatment plan.
    We estimate that 1 percent of the total enrollment of 2,300,000 
(23,000) are enrolled in either a MCO, PIHP or both, and would qualify 
as an individual with special health care needs. The time needed for 
the assessment and for treatment planning will, on average, take 1 hr 
at $66.92/hr for a registered nurse to complete. In aggregate, we 
estimate an annual private sector burden of 23,000 hr (23,000 enrollees 
x 1 hr) and $1,539,160 (23,000 hr x $66.92/hr).Section 438.210(c), 
adopted in CHIP through Sec.  457.1230(d), requires that each contract 
provide that the MCO, PIHP, or PAHP notify the requesting provider, and 
give the enrollee written notice of any decision by the MCO, PIHP, or 
PAHP to deny a service authorization request, or to authorize a service 
in an amount, duration, or scope that is less than requested.
    We estimate an annual private sector burden of 30 min at $66.92/hr 
for a registered nurse to generate the notice. We estimate that each of 
58 MCOs, PIHPs and PAHPs will process 20 denials/service reductions per 
1,000 members. This is our best estimate based on the data available in 
the SEDS, conversations with states and observations of trends in 
Medicaid and the commercial market. With average enrollment of 78,000, 
each entity is estimated to process a total of 1,560 denials and 
service reductions annually. In aggregate, we estimate 45,240 hr (58 
entities x 1,560 denials or service reductions/entity x 30 min) and $3, 
027,460.80 (45,240 hr x $66.92/hr).
54. ICRs Regarding Structure and Operation Standards (Sec.  457.1233)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with revisions to update the wage 
data and amend the estimates on the number of plans affected. No 
comments were received. Although we added paragraph Sec.  457.1233(d) 
in response to comments (as discussed in section II.B.20), it 
references an existing CHIP requirement, and will not create additional 
burden.
    Section 457.1233 applies the requirements of Sec. Sec.  438.214, 
438.230, 438.236, and 438.242 to CHIP. Section 438.214 requires that 
MCOs, PIHPs, and PAHPs have policies for the selection and retention of 
providers. As described in section V.C.54. of this final rule, we 
believe that the requirements in Sec.  438.214 are part of the usual 
course of business and will not add additional burden onto entities 
because the entities will have policies for selecting and retaining 
providers even in the absence of these regulations.
    Section 438.230, adopted in CHIP through Sec.  457.1233(b), 
requires that MCOs, PIHPs, and PAHPs oversee subcontractors and 
specifies the subcontracted activities. We estimate 3 hr at $64.46/hr 
for a business operations analyst to amend appropriate contracts. We 
estimate a one-time private sector burden of 174 hr (58 MCOs, PIHPs, 
and PAHPs x 3 hr) and $11,216.04 (174 hr x $64.46). We are annualizing 
the one-time development since we do not anticipate any additional 
burden after the 3-year approval period expires.
    Section 438.236(c), adopted in CHIP through Sec.  457.1233(c), 
requires that each MCO, PIHP, and PAHP disseminate guidelines to its 
affected providers and, upon request, to enrollees and potential 
enrollees. The burden associated with this requirement is the time 
required to disseminate the guidelines, usually by posting on their Web 
site. This is typically done annually. We estimate an annual private 
sector burden of 2 hr at $64.46/hr for a business operations 
specialist. In aggregate, we estimate 116 hr (58 entities x 2 hr) and 
$7, 477.36 (116 hr x $64.46/hr). In Sec.  438.242(b)(2), adopted in 
CHIP through Sec.  457.1233(b), the state is required to stipulate that 
each MCO and PIHP collect data on enrollee and provider characteristics 
(as specified by the state) and on services furnished to enrollees 
(through an encounter data system or other such methods as may be 
specified by the state). We estimate a one-time private sector burden 
of 20 hr at $78.32/hr for a computer programmer to extract this data 
from an entity's system and report to the state. In aggregate, we 
estimate 1,100 hr (55 entities x 20 hr) and $86,152 (1,100 hr x $78.32/
hr). We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires. After the initial

[[Page 27799]]

creation, the reports will be set to run and sent to the state at 
specified times as part of a production schedule.
55. ICRs Regarding Quality Measurement and Improvement (Sec.  457.1240)
    No comments were received on the burden estimates in the proposed 
rule. However, we are revising the burden estimates in response to the 
changes to the regulation discussed in II.B.21.
    Section 457.1240 applies the requirements of Sec. Sec.  438.330, 
438.332, 438.334, and 438.340 to CHIP. Section 438.330(a)(2), adopted 
in CHIP through Sec.  457.1240(b), specifies the process CMS will use 
if it elects to specify national QAPI and PIP topics, which will 
include a public notice and comment process. Assuming that we do use 
this process to identify performance measures and PIP topics at least 
once every 3 years, the burden for states will be altered. Some may 
experience a decrease in the time spent selecting performance measures 
and PIP topics while others might experience a slight increase in the 
form of programming their MMIS systems to account for the specified 
performance measures and PIP topics.
    We estimate that MMIS programming changes requires 10 hr (every 3 
years) at $78.32/hr for a computer programmer. In aggregate, we 
estimate an ongoing annualized state burden of 83 hr [(25 states x 10 
hr)/3 years] and $6,500.56 (83 hr x 78.32/hr). We cannot estimate the 
amount of possible decrease in burden as we have no way to know the 
average amount of time a state expended on selecting performance 
measures or PIP topics and how this might change based on this 
revision. Section 438.330(a)(2)(i) allows states to apply for an 
exemption from the CMS-required performance measure and PIP topic 
requirements established under Sec.  438.330(a)(2). While we have no 
data on how many states would take advantage of this option, given that 
the performance measures and PIP topics under Sec.  438.330(a)(2) would 
be identified through a public notice and comment process, we estimate 
that 2 states would ask for an exemption every 3 years. We estimate 
that the exemption process would require 1 hr at $64.46/hr for a 
business operations specialist. In aggregate, we estimate an ongoing 
annualized state burden of 0.67 hr [(2 states x 1 hr)/3 years] and 
$42.54 (0.67 hr x $64.46/hr).
    Section 438.330(a)(2)(ii), adopted in CHIP through Sec.  
457.1240(b), allows states to select performance measures and PIPs in 
addition to those specified by CMS under Sec.  438.330(a)(2). Since 
this language continues the flexibility available to states today, we 
do not believe this creates any change in burden for states or the 
private sector.
    Section 438.330(b)(3) clarifies that MCOs, PIHPs, and PAHPs must 
have an approach to evaluate and address findings regarding the 
underutilization and overutilization of services. Because utilization 
review in managed care has become commonplace in the private, Medicare, 
and Medicaid settings, we do not believe that this regulatory provision 
imposes any new burden on MCOs, PIHPs, or PAHPs.
    In accordance with Sec.  438.310(c)(2), some PCCM entities (we 
estimate 3) will now be subject to the requirements of Sec.  
438.330(b)(3). We estimate a one-time private sector burden of 10 hr at 
$64.46/hr for a business operations specialist to establish the 
policies and procedures. In aggregate, we estimate 30 hr (3 PCCMs x 10 
hr) and $1,933.80 (30 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires. We also estimate an ongoing burden of 
10 hr to evaluate and address the findings. In aggregate, we estimate 
an annual burden of 30 hr (3 PCCMs x 10 hr) and $1,933.80 (30 hr x 
$64.46/hr) for program maintenance.
    Section 438.330(c) addresses QAPI performance measurement. Section 
438.330(c)(1), adopted in CHIP through Sec.  457.1240(b), requires the 
state to identify standard performance measures for their managed care 
plans, including LTSS measures if appropriate. We believe that it is 
standard practice for states to identify performance measures for their 
contracted managed care plans; therefore there is no burden associated 
with this paragraph.
    Section 438.310(c)(2), adopted in CHIP through Sec.  457.1240(b), 
requires each MCO, PIHP, PAHP, and PCCM entity (described in Sec.  
438.310(c)(2)) to annually measure its performance using the standard 
measures specified by the state in paragraph (c)(1) and to report on 
its performance to the state. We assume that each of the MCOs and PIHPs 
would report on three performance measures to the state. The use of 
performance measures is commonplace in private, Medicare, and Medicaid 
managed care markets; therefore we believe that MCOs and PIHPs already 
collect performance measures.
    We recognize that PAHPs and PCCM entities (described in Sec.  
438.310(c)(2)) may not currently engage in performance measurement as 
described in Sec.  438.330(c)(2), and estimate that 7 entities might be 
impacted. We estimate that, in any given year, each PCCM entity and 
each PAHP would report to the state on 3 performance measures. We 
estimate an annual private sector burden of 4 hr per measure at $64.46/
hr for a business operations specialist to prepare a report for each 
performance measure. In aggregate, we estimate 84 hr [(3 PAHPs + 4 
PCCMs) x 3 performance measures x 4 hr] and $5,414.64 (84 hr x $64.46/
hr).
    Section 438.330(c)(1)(ii) requires states to identify standard 
performance measures in two LTSS-specific categories for managed care 
plans that provide LTSS. We do not know of any states that have an LTSS 
plan in CHIP, so there is no burden associated with the proposed 
provision.
    In Sec.  438.330(d), adopted in CHIP through Sec.  457.1240(b), 
states must ensure that each MCO, PIHP and PAHP have an ongoing program 
of PIPs, designed to achieve sustainable improvement, which the managed 
care plan will report on to the state as requested, but at least once 
per year. We assume that each MCO and PIHP will conduct at least 3 PIPs 
and each of the 3 PAHPs would conduct at least 1 PIP. We further expect 
that states will request the status and results of each entity's PIPs 
annually. Given that PAHPs may not currently conduct PIPs, we estimate 
a one-time private sector burden of 2 hr at $64.46/hr for a business 
operations specialist to develop policies and procedures, for an 
aggregate burden of 6 hr (3 PAHPs x 2 hr) and $386.76 (6 hr x 64.46/
hr). We are annualizing the one-time development since we do not 
anticipate any additional burden after the 3-year approval period 
expires. We estimate an annual burden of 8 hr to prepare a report on 
each PIP. In aggregate, we estimate 1,344hr [((55 MCOs and PIHPs x 3 
PIPs) + (3 PAHPs x 1 PIP)) x 8 hr] and $86,634.24 (1,344hr x $64.46/hr) 
to prepare the report.
    Per Sec.  438.310(c)(2), PCCM entities specified are also subject 
to the requirements in Sec.  438.330(e) through Sec.  457.1240(b). We 
estimate an annual state burden of 15 hr at $64.46/hr for a business 
operations specialist to assess the performance of a single Sec.  
438.3(r) PCCM entity. In aggregate, we estimate 45 hours (3 PCCM 
entities x 15 hr) and $2,900.70 (45 hr x $64.46/hr).
    Section 438.330(e)(1)(ii), adopted in CHIP through Sec.  
457.1240(b), requires that states include outcomes and trended results 
of each MCO, PIHP, and PAHP's PIPs in the state's annual review of QAPI 
programs. We estimate a one-time state burden of 0.5 hr at $64.46/hr 
for a business operations specialist to modify the state's policies and 
procedures. We are annualizing the one-

[[Page 27800]]

time development since we do not anticipate any additional burden after 
the 3-year approval period expires. In aggregate, we estimate 12.5 hr 
(25 states x 0.5 hr) and $805.75 (12.5 hr x 64.46/hr). We also estimate 
an annual burden of 1 hr for the additional review. In aggregate, we 
estimate 25 hr (25 states x 1 hr) and $1,611.5 (25 hr x $64.46/hr).
    Section 438.330(e)(1)(iii) sets out a new requirement, related to 
Sec.  438.330(b)(5), requiring that the state must assess the 
rebalancing effort results for LTSS in its annual review. We do not 
know of any states that have an LTSS plan in CHIP, so there is no 
burden associated with the proposed provision.
    Under Sec.  438.332(a), adopted in CHIP through Sec.  457.1240(c), 
states must confirm the accreditation status of contracted MCOs, PIHPs, 
and PAHPs once a year. We estimate an annual state burden of 0.25 hr at 
$64.46/hr for a business operations specialist to review the 
accreditation status of each of the estimated 58 MCOs, PIHPs, and 
PAHPs. In aggregate, we estimate an annual burden of 14.5 hr (0.25 hr x 
58 MCOs, PIHPs, and PAHPs) and $934.67 (14.5 hr x $64.46/hr).
    Section 438.332(b), adopted in CHIP through Sec.  457.1240(c), 
describes the information MCOs, PIHPs, and PAHPs must authorize the 
private accrediting entity to release to the state regarding the plan's 
accreditation status. We believe that states will need to amend their 
MCO, PIHP, and PAHP contracts to reflect this requirement, and estimate 
a one-time burden of 0.25 hr per contract amendment. In aggregate, we 
estimate a one-time burden of 15.5 hr (0.25 hr x 58 MCOs, PIHPs, and 
PAHPs) and $934.67 (14.5 hr x 64.46/hr). We are annualizing the one-
time development since we do not anticipate any additional burden after 
the 3-year approval period expires.
    Under Sec.  438.332(c), adopted in CHIP through Sec.  457.1240(c), 
states will document the accreditation status of each contracted MCO, 
PIHP, and PAHP on the state's Web site, and will update this 
information at least annually. The burden is included in Sec.  
457.1207.
    Section 438.334, adopted in CHIP through Sec.  457.1240(d), 
requires each state that contracts with an MCO, PIHP, or PAHP to adopt 
a quality ratings system to generate plan ratings annually. States must 
either adopt the quality rating system developed by CMS in accordance 
with Sec.  438.334(b) or an alternative quality rating system in 
accordance with Sec.  438.334(c).
    We assume that states will utilize the same system and processes 
developed for CHIP managed care plans as was developed for Medicaid 
managed care plans. Using the assumptions developed for Sec.  438.332, 
we estimate that 17 states (with 46 MCOs, PIHPs, and PAHPs) will elect 
to adopt the quality rating system developed by CMS in accordance with 
Sec.  438.334(b), while the remainder (8 states with 16 MCOs, PIHPs, 
and PAHPs) will elect to use an alternative quality rating system in 
accordance with Sec.  438.334(c). We assume that, given the robust 
public engagement process CMS will use to develop the QRS in accordance 
with Sec.  438.334(b), states electing to adopt the CMS-developed QRS 
will not need to conduct additional public engagement and will require 
less time to develop their QRS as compared to states which elect to 
adopt an alternative QRS consistent with Sec.  438.334(c).
    Therefore, for states adopting the CMS-developed QRS under Sec.  
438.334(b), we estimate the state burden for the development and 
implementation of the QRS as 200 hr at $64.46/hr for a business 
operations specialist, 100 hr at $78.32/hr for a computer programmer, 
and 30 hr at $140.80/hr for a general and operations manager. In 
aggregate, we estimate a one-time state burden of 5,610 hr (17 states x 
330 hr) and $424,116 [17 states x ((200 hr x $64.46/hr) + (100 hr x 
$78.32/hr) + (30 hr x $140.80/hr)] for the development of a state's 
quality rating system consistent with 438.334(b). We are annualizing 
the one-time development since we do not anticipate any additional 
burden after the 3-year approval period expires.
    The burden is more variable for states seeking CMS approval for the 
adoption of an alternative QRS per Sec.  438.334(c). A state may submit 
an existing QRS, may submit a modified version of an existing QRS, or 
may develop a new QRS. We assume that the burden for each of these 
options would vary by state; therefore, we estimate an average burden 
for the development of an alternative QRS. We believe that the average 
alternative QRS burden will exceed the burden to adopt the CMS-
developed QRS, and will require public engagement by the state. 
Therefore, we estimate the average state burden for the development and 
implementation of an alternative QRS as 800 hr at $64.46/hr for a 
business operations specialist, 400 hr at $78.32/hr for a computer 
programmer, and 120 hr at $140.80/hr for a general and operations 
manager. We estimate an additional 20 hr at $36.54/hr for an office and 
administrative support worker for the public engagement process and an 
additional 50 hr at $64.46/hr for a business operations specialist to 
review and incorporate public feedback. In aggregate, we estimate a 
one-time state burden of 11,120 hr (8 states x 1,390 hr) and 
$829,966.40 [8 states x ((800 hr x $64.46/hr) + (400 hr x $78.32/hr) + 
(120 hr x $140.80/hr) + (20 hr x $36.54/hr) + (50 hr x $64.46/hr))] for 
the development of a state's alternative quality rating system 
consistent with Sec.  438.334(c). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
    To elect the option under Sec.  438.334(c) to use an alternative 
QRS, a state will submit a request to CMS and must receive written CMS 
approval. We estimate a one-time state burden of 20 hr at $64.46/hr for 
a business operations specialist to seek and receive approval from CMS 
for the state's alternative quality rating system. In aggregate, we 
estimate 160 hr (8 states x 20 hr) and $10,313.60 (160 hr x $64.46/hr). 
We are annualizing the one-time development since we do not anticipate 
any additional burden after the 3-year approval period expires.
    Section 438.334(c)(3) outlines the process for a state to make 
changes to an approved alternative QRS. We estimate that it will 
require 5 hr at $36.54/hr for an office and administrative support 
worker and 25 hr at $64.46/hr for a business operations specialist to 
complete the public comment process, and an additional 5 hr at $64.46/
hr from a business operations specialist to seek and receive approval 
from CMS for the change. While we have no data to estimate how 
frequently a state may elect to alter an approved alternative QRS, we 
estimate that CMS will revise the QRS under Sec.  438.334(b) on average 
approximately once every 3 years. We assume that states will revise 
their alternative QRS on a similar frequency to ensure that the 
alternative QRS continues to yield substantially comparable information 
regarding MCO, PIHP, and PAHP performance, and apply this assumption 
here. Therefore, we estimate an aggregate annualized burden of 93 hr 
[(8 states x 35 hr)/3 years] and $5,644 [(8 states x (5 hr x $36.54/hr) 
+ (30 x $64.46/hr))/3 years]. Under Sec.  438.334(d), each state will 
collect information from its MCOs, PIHPs, and PAHPs to calculate and 
then issue a quality rating each year. We expect that states will rely 
on information and data already provided to them by their MCOs, PIHPs, 
and PAHPs; therefore, we do not expect this data collection to pose an 
additional burden on the private sector. However, each year states will 
rate each MCO, PIHP, or PAHP with which they contract. We estimate 40 
hr at $64.46/hr for a business operations specialist

[[Page 27801]]

for a state to rate a MCO, PIHP, or PAHP. We believe this burden will 
be similar for states regardless of if they adopt the CMS-developed QRS 
consistent with Sec.  438.334(b) or the alternative QRS consistent with 
Sec.  438.334(c).In aggregate, we estimate an annual state burden of 
2,320 hr (58 MCOs, PIHPs, and PAHPs x 40 hr) and $149,547.20 (2,320 hr 
x $64.46/hr).
    Section 438.340, adopted in CHIP through Sec.  457.1240(e), 
requires states to have a quality strategy for managed care. In 
accordance with Sec.  438.340(c)(2), states will review and revise 
their quality strategies as needed, but no less frequently than once 
every 3 years. While the 25 states that contract with MCOs and/or PIHPs 
currently revise their quality strategies periodically, approximately 
half of those states (13) revise their quality strategies less 
frequently than proposed. We estimate a burden for the revision of a 
quality strategy of, once every 3 years, 25 hr at $64.46/hr for a 
business operations analyst to review and revise the comprehensive 
quality strategy, 2 hr at $36.54/hr for an office and administrative 
support worker to publicize the strategy, 5 hr at $64.46/hr for a 
business operations specialist to review and incorporate public 
comments, and 1 hr at $36.54/hr for an office and administrative 
support worker to submit the revised quality strategy to CMS. In 
aggregate, we estimate an ongoing annualized state burden of 143 hr 
[(13 states x 33 hr)/3 years] and $8,854.82 [(13 states x (30 hr x 
$64.46/hr) + (3 hr x $36.54/hr))/3 years].
    The revision of a quality strategy will be a new process for the 
estimated three states with only PAHPs and the estimated two states 
with only PCCM entities. We estimate that those states need 0.5 hr at 
$64.46/hr for a business operations specialist to revise their policies 
and procedures. In aggregate, we estimate a one-time state burden of 
2.5 hr (5 states x 0.5 hr) and $161.15 (2.5 hr x $64.46/hr) to update 
policies and procedures. We are annualizing the one-time development 
since we do not anticipate any additional burden after the 3-year 
approval period expires.
    We assume that it will be less burdensome to revise an existing 
quality strategy than to draft an initial strategy. Therefore, we 
estimate a burden for the quality strategy revision process, once every 
3 years, of 25 hr at $64.46/hr for a business operations analyst to 
review and revise the comprehensive quality strategy, 2 hr at $36.54/hr 
for an office and administrative support worker to publicize the 
strategy, 5 hr at $64.46/hr for a business operations specialist to 
review and incorporate public comments, and 1 hr at $36.54/hr for an 
office and administrative support worker to submit the revised quality 
strategy to CMS. In aggregate, we estimate an ongoing annualized state 
burden of 55 hr [(5 states x (33 hr)/3 years] and $3,405.70 [(5 states 
x ((30 hr x $64.46/hr) + (3 hr x $36.54/hr))/3 years].
    Consistent with Sec.  438.340(c)(2), the review of the quality 
strategy will include an effectiveness evaluation conducted within the 
previous 3 years. We estimate the burden of this evaluation at 40 hr at 
$64.46/hr for a business operations specialist once every 3 years for 
all 25 states that contract with MCOs, PIHPs, PAHPs, and/or PCCM 
entities (described in Sec.  438.310(c)(2)). We estimate an annualized 
burden of 333 hr [(25 states x 40 hr)/3 years] and $21,486.67 (333 hr x 
$64.46/hr) to evaluate the effectiveness of a quality strategy.
    States will post the effectiveness evaluation on the state's 
Medicaid Web site under Sec.  438.340(c)(2)(iii). In the proposed rule 
we states that while this standard was subject to the PRA, we believed 
that the associated burden is exempt from the PRA in accordance with 5 
CFR 1320.3(b)(2). We believed that the time, effort, and financial 
resources necessary to comply with the aforementioned standards will be 
incurred by persons during the normal course of their activities and, 
therefore, should be considered a usual and customary business 
practice. Upon further consideration, however, we determined that 
states today do not necessarily post the quality strategy effectiveness 
evaluation online. Therefore, we estimate that posting the quality 
strategy effectiveness evaluation online will require 0.25 hr at $64.46 
from a business operations specialist once every 3 years. In aggregate, 
we estimate an ongoing annualized burden of 3.5 hr [(42 states x 0.25 
hr)/3 years] and $225.61 (3.5 hr x $64.46/hr).
    As described in Sec.  438.340(c)(3), states will submit to CMS a 
copy of the initial quality strategy and any subsequent revisions. The 
burden associated with this standard has been incorporated into burden 
estimates for initial and revised quality strategies. As this will be a 
new standard for the estimated 3 states with only PAHPs and the 
estimated 2 states with only PCCM entities, we believe that these 
states will need to modify their policies and procedures to incorporate 
this action. We estimate a burden of 0.5 hr $64.46/hr for a business 
operations specialist. In aggregate, we estimate a one-time state 
burden of 2.5 hr (5 states x 0.5 hr) and $161.15 (2.5 hr x $64.46/hr). 
We are annualizing the one-time development since we do not anticipate 
any additional burden after the 3-year approval period expires.
    Finally, Sec.  438.340(d) requires states to post the final quality 
strategy to their Medicaid Web sites. In the proposed rule, we stated 
that while this standard was subject to the PRA, we believed that the 
associated burden is exempt from the PRA in accordance with 5 CFR 
1320.3(b)(2). We believed that the time, effort, and financial 
resources necessary to comply with the aforementioned standards will be 
incurred by persons during the normal course of their activities and, 
therefore, should be considered a usual and customary business 
practice. Upon further consideration, however, we determined that 
states today do not necessarily post the final quality strategy online, 
though some do. Therefore, we estimate that posting the final quality 
strategy online will require 0.25 hr at $64.46 from a business 
operations specialist once every 3 years. In aggregate, we estimate an 
ongoing annualized burden of 3.5 hr [(42 states x 0.25 hr)/3 years] and 
$225.61 (3.5 hr x $64.46/hr).
56. ICRs Regarding External Quality Review (Sec.  457.1250)
    No comments were received on the burden estimates in the proposed 
rule. However, we are revising the burden estimates in response to the 
changes to the regulation discussed in II.B.22.
    Section 457.1250 applies the requirements of Sec. Sec.  438.350, 
438.352, 438.354, 438.356, 438.358, and 438.364 to CHIP. Section 
438.350, adopted in CHIP through Sec.  457.1250(a), requires that 
states include CHIP in their EQR. We anticipate that most states 
includes CHIP in their Medicaid contract with the EQRO and that the 
burden for adding CHIP will be included in the burden for adding PAHPs 
to the EQRO contract. We anticipate that 5 states may contract 
separately for CHIP EQR services and that this requires states to 
procure a new vendor.
    Section 438.358, adopted in CHIP through Sec.  457.1250(a), 
addresses the EQR-related activities. Per Sec.  438.358(a)(1) of this 
section, the EQR-related activities described in paragraphs (b) and (c) 
of this section may be conducted by the state, its agent that is not an 
MCO, PIHP, PAHP, or PCCM entity (described in Sec.  438.310(c)(2)), or 
an EQRO; we describe the burden assuming that the state conducts these 
activities, though we believe the burdens will be similar regardless of 
who conducts each activity.

[[Page 27802]]

    The burden associated with the mandatory EQR-related activities 
described in Sec.  438.358(b)(1) of this section is the time for a 
state to conduct and document the findings of the four mandatory 
activities: (1) The annual validation of PIPs conducted by the MCO/
PIHP/PAHP; (2) the annual validation of performance measures calculated 
by the MCO/PIHP/PAHP; (3) once every 3 years, a review of MCO/PIHP/PAHP 
compliance with structural and operational standards; and (4) 
validation of MCO, PIHP, and PAHP network adequacy. Each of these 
activities will be conducted on the 5 MCOs/PIHPs/PAHPs that are 
currently providing CHIP services separately from Medicaid.
    The types of services provided by these managed care entities, the 
number of PIPs conducted, and the performance measures calculated will 
vary. We assume that each MCO/PIHP will conduct at least 3 PIPs, each 
PAHP will conduct at least 1 PIP, and that each MCO/PIHP/PAHP will 
calculate at least 3 performance measures.
    For a business operations specialist to conduct the mandatory EQR 
activities at $64.46/hr, we estimate an annual state burden of 65 hr 
(PIP validation), 53 hr (performance measure validation), 361 hr 
(compliance review; occurs once every 3 years), and 60 hr (validation 
of network adequacy activity). In aggregate, we estimate 2,671.67hr (5 
x [(65 hr x 3 PIPs) + (53 hr x 3 performance measures) + (361 hr/3) + 
60 hr]) and $142,453.27 (2,372 hr x $64.46/hr).
    In Sec.  438.358(b), the burden will include the time for an MCO/
PIHP/PAHP to prepare the information necessary for the state to conduct 
the three mandatory activities. We estimate that it will take each MCO/
PIHP/PAHP 160 hr to prepare the documentation for these activities. We 
estimate that one-half of the time will be for preparing the 
information which will be performed by a business operations specialist 
at $64.46/hr while the other half will be performed by office and 
administrative support worker at $36.54/hr. In aggregate, we estimate a 
private sector burden of 800 hr (5 states x 160 hr) and $40,400.00 [(5 
states x 80 hr x $64.46/hr) + (5 states x 80 hr x $36.54/hr).
    The fourth mandatory EQR-related activity described in Sec.  
438.358(b)(1)(iv) requires the validation of MCO, PIHP, and PAHP 
network adequacy during the preceding 12 months. States will conduct 
this activity for each MCO, PIHP, and PAHP. Given that this is a new 
activity, we do not have historic data on which to base an hourly 
burden estimate for the network validation process. We estimate that it 
will take less time than the validation of a PIP but more time than the 
validation of a performance measure. Therefore, we estimate an annual 
state burden of 60 hr at $64.46/hr for a business operations specialist 
to support the validation of network adequacy activity. In aggregate, 
we estimate 3,480hr (58 MCOs, PIHPs, and PAHPs x 60 hr) and $224,320.80 
(3,480 hr x $64.46/hr) for the validation of network adequacy activity.
    Section 438.358(b)(2) describes the mandatory EQR-related 
activities which must be conducted for each PCCM entity (described in 
Sec.  438.310(c)(2)), specifically the activities described in 
paragraphs (b)(1)(ii) and (b)(1)(iii) of this section. Given that we do 
not have data to estimate the time required for each of these 
activities for these PCCM entities, we rely on the time per activity 
estimates used for MCOs, PIHPs, and PAHPs; we assume the validation of 
one performance measure per PCCM entity (described in Sec.  
438.310(c)(2)). Therefore, we estimate an annual state burden of 693.2 
hr (4 PCCM entities x 173.3 hr [(53 hr x 1 performance measure) + (361 
hr/3 years)]) and $33,512.75 (693.2 hr x $64.46/hr) for the mandatory 
EQR-related activities for PCCM entities (described in Sec.  
438.310(c)(2)). The burden associated with Sec.  438.358(b)(1) also 
includes the time for an MCO, PIHP, or PAHP to prepare the information 
necessary for the state to conduct the mandatory EQR-related 
activities. We estimate that it will take each MCO, PIHP, or PAHP 200 
hr to prepare the documentation for these four activities, half (100 
hr) at $64.46/hr by a business operations specialist and half (100 hr) 
at $36.54/hr by an office and administrative support worker. The burden 
associated with Sec.  438.358(b)(2) also includes the time for a PCCM 
entity (described in Sec.  438.310(c)(2)) to prepare the information 
necessary for the state to conduct the mandatory EQR-related 
activities. Given the estimate of 200 hr for an MCO, PIHP, or PAHP, and 
that there are only 2 mandatory EQR-related activities for PCCM 
entities (described in Sec.  438.310(c)(2)), we estimate it will take 
100 hr to prepare the documentation for these 2 activities, half (50 
hr) at $64.46/hr by a business operations specialist and half (50 hr) 
at $36.54/hr by an office an administrative support worker. In 
aggregate, we estimate an annual private sector burden of 12,000 hr 
[(58 MCOs, PIHPs, and PAHPs x 200 hr) + (3 PCCM entities x 100 hr)] and 
$641,350 [(6,000 hr x $64.46/hr) + (6,000 hr x $36.54/hr)].
    Section 438.358(c), adopted in CHIP through Sec.  457.1250(a), 
describes optional EQR-related activities. The number of MCOs/PIHPs 
engaged in optional EQR-related activities will vary. We estimate 48 
MCOs/PIHPs will be engaged in validation of client encounter data 
through a state contract with an EQR; 30 MCOs/PIHPs will be engaged in 
validation of consumer or provider surveys through a state contract 
with an EQR; 26 MCOs/PIHPs will be engaged in performance improvement 
projects (PIPs) conducted by an EQR; 20 MCO/PIHPs will be engaged in 
calculating performance measures through a state contract with an EQR; 
and 52 MCOs/PIHPs will be engaged in conducting focused studies. For 
the optional EQR activities, we have no data to estimate how long it 
will take to conduct these activities. We, therefore, estimate that it 
will take 350 hr to validate client level data and 50 hr to validate 
consumer or provider surveys. We estimate it will take three times as 
long to calculate performance measures as it takes on average to 
validate (159 hr) and three times as long to conduct PIPs and focused 
studies as it takes on average to validate PIPs (195 hr) (see 
discussion at IV.C.25). We also estimate that it will take three times 
as long to administer a consumer or provider survey than it takes to 
validate a survey (60 hr).
    For a business operations specialist $64.46/hr, we estimate: (1) 
16,800 hr (350 hr x 48 MCOs/PIHPs) and $1,082,928.00 (16,800hr x 
$64.46/hr) to validate client level data; (2) 1500 hr (50 hr x 30 MCOs/
PIHPs) and $96,690.00 (1500 hr x 64.46/hr) to validate consumer or 
provider surveys; (3) 3,180 hr (159 hr x 20 MCOs/PIHPs) and $204,982.80 
(3,180 hr x $64.46/hr) to calculate performance measures; (4) 5,070 hr 
(195 hr x 26 MCOs/PIHPs) and $326,812.20 (5,070 hr x $64.46/hr) to 
conduct PIPs; and (5) 8,268 hr (159 hr x 52 MCOs/PIHPs) and $532,955.28 
(8,268 hr x $64.46/hr) to conduct focused studies. In aggregate, we 
estimate 34,818 hr and $1,856,495.76 for the optional EQR-related 
activities.
    The optional EQR-related activities described in Sec.  438.358(c) 
may also be conducted on PAHPs and PCCM entities (described in Sec.  
438.310(c)(2)). Since neither PAHPs or PCCM entities (described in 
Sec.  438.310(c)(2)) have historically been subject to EQR, we do not 
have any data on which to base an estimate regarding how states will 
apply the optional EQR-related activities to these delivery systems. 
Section 438.358(c)(6) allows a state to contract with an EQRO to 
support the quality rating of MCOs, PIHPs, and PAHPs consistent with 
Sec.  438.334. We do not believe that the effort required to rate a

[[Page 27803]]

plan changes based on which entity (state or EQRO) develops the plan 
rating. Therefore, we believe that any burden associated with this 
optional EQR-related activity will only offset the burden associated 
with Sec.  438.334(d).
    Section 438.364(a), adopted in CHIP through Sec.  457.1250(a), 
describes the information that will be included in the annual detailed 
technical report that is the product of the EQR. Section 
438.364(a)(1)(iii) specifies that the EQR technical report includes 
baseline and outcomes data regarding PIPs and performance measures. 
Many states already provide much of this information in their final EQR 
technical report. The burden of compiling this data for MCOs, PIHPs, 
and PAHPs is captured in Sec.  438.358. Under Sec.  438.364(a)(3), EQR 
technical reports will include recommendations on how the state can use 
the goals and objectives of its comprehensive quality strategy to 
support improvement in the quality, timeliness, and access to care for 
beneficiaries. We believe that states will amend their EQRO contracts 
to address the changes to Sec.  438.364(a). We estimate a one-time 
state burden of 0.5 hr at $64.46/hr for a business operations 
specialist to amend the EQRO contract. In aggregate, we estimate 12.5 
hr (25 states x 0.5 hr) and $805.75 (12.5 hr x $64.46/hr). We are 
annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires.
    Section 438.364(c)(1), adopted in CHIP through Sec.  457.1250(a), 
clarifies that the EQRO will produce and finalize the annual EQR-
technical report and that states may not substantively revise the 
report without evidence of error or omission. The April 30th deadline 
for the finalization and submission of EQR technical reports is 
consistent with existing Medicaid sub-regulatory guidance.
    While we do not anticipate that these changes will pose a 
significant burden on states or the private sector, we estimate that 
this provision may necessitate a change in a state's EQRO contract for 
approximately 5 states. In this regard, we estimate a one-time state 
burden of 0.5 hr at $64.46/hr for a business operations specialist to 
modify the EQRO contract. In aggregate, we estimate 2.5 hr (5 states x 
0.5 hr) and $161.15 (2.5 hr x $64.46/hr). We are annualizing the one-
time development since we do not anticipate any additional burden after 
the 3-year approval period expires.
    Section 438.364(c)(2)(ii), adopted in CHIP through Sec.  
457.1250(a), requires that each state agency provide copies of 
technical reports, upon request, to interested parties such as 
participating health care providers, enrollees and potential enrollees 
of the MCO/PIHP/PAHP, beneficiary advocacy groups, and members of the 
general public. States will also be required to make the most recent 
EQR technical report publicly available in a manner specified by CMS. 
This will likely be accomplished by posting to the state's Web site, 
the burden for which is included in Sec.  457.1206.
    We believe that by making these reports available online, states 
will be able to significantly decrease the burden associated with 
responding to requests from the public for this information, as it will 
already be easily accessible. The burden associated with this 
requirement is the time for a state agency to disclose copies of a 
given technical report to interested parties.
    We estimate an annual state burden of 5 min at $36.54/hr for office 
and administrative support worker to disclose the required information 
per request. We also estimate that each state will receive 5 requests 
per MCO/PIHP/PAHP per year. In aggregate, we estimate 24.1 hr (58 MCOs/
PIHPs/PAHPs x 5 requests x 5 min) and $880.61 (24.1 hr x $36.54/hr).
57. ICRs Regarding Grievances (Sec.  457.1260)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to update the 
wage estimates and to reduce the number of states affected based on 
updated information obtained from SEDS. No comments were received.
    Section 457.1260 applies subpart F of part 438 to CHIP. We 
anticipate that most states currently follow the Medicaid grievance 
procedures, so we adopt the burden associated with the proposed changes 
to the Medicaid regulation.
    Section 438.400(b), adopted in CHIP through Sec.  457.1260, updates 
the definition of ``Action'' to ``Adverse benefit determination,'' 
clarify ``appeal'' and ``grievance,'' and add the definition of 
``grievance system.'' We estimate a one-time state burden of 5 hr at 
$64.46/hr for a business operations specialist to amend all relevant 
documents to the new nomenclature and definitions. In aggregate, we 
estimate 165 hr (5 hr x 25 states) and $8,057.50 (125 hr x $64.46/hr). 
We are annualizing the one-time development since we do not anticipate 
any additional burden after the 3-year approval period expires.
    Aligning the definition of ``adverse benefit determination'' to 
include medical necessity, appropriateness, health care setting, or 
effectiveness requires that plans provide additional hearing resources 
to actions previously not included. We estimate 3 hr at $64.46/hr for a 
business operations specialist and expect that each plan will provide 3 
additional hearings per month (36 per year). In aggregate, we estimate 
an annual private sector burden of 6,264 hr (58 MCOs, PIHPs, and PAHPs 
x 36 hearings x 3 hr) and $403,777.44 (6,264 hr x $64.46/hr). Section 
438.402, adopted in CHIP through Sec.  457.1260, specifies the general 
requirements associated with the grievance system. More specifically, 
Sec.  438.402: (1) Requires MCOs, PIHPs, and PAHPs to have a grievance 
system; (2) sets out general requirements for the system; (3) 
establishes filing requirements; and (4) provides that grievances and 
appeals may be filed either orally or in writing. The proposed 
provisions apply to 58 entities. The burden for revising the contracts 
for these entities is included in Sec.  457.1201.
    With regard to setting up a grievance system, we estimate it will 
take 100 hr (10 hr at $140.80/hr for a general and operations manager, 
75 hr at $64.46/hr for a business operations specialist, and 15 hr at 
$78.32/hr for a computer programmer) for each entity. We estimate that 
the entities will receive 400 grievances per month. We estimate it will 
take a business operations specialist 30 min to process and handle each 
grievance and adverse benefit determinations.
    We estimate a one-time private sector burden of 5,800 hr and 
$430,203.40 [58 MCOs, PIHPs, and PAHPs x ((10 x $140.80/hr) + (75 x 
$64.46/hr) + (15 x $78.32/hr)). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires. We also estimate an ongoing annual 
burden of 139,200 hr [58 MCOs, PIHPs, and PAHPs x 400 grievances/month 
x 12 months x 0.5 hr/grievance] and $8,972,832.00 (139,200 hr x $64.46/
hr) for processing each grievance and adverse benefit determination.
    Section 438.404(a), adopted in CHIP through Sec.  457.1260, adds 
PAHPs as an entity that must give the enrollee timely written notice 
and sets forth the requirements of that notice. More specifically, the 
enrollee must be provided timely written notice if an MCO, PIHP, or 
PAHP intends to: (1) Deny, limit, reduce, or terminate a service; (2) 
deny payment; (3) deny the request of an enrollee in a rural area with 
one plan to go out of network to obtain a service; or (4) fails to 
furnish, arrange, provide, or pay for a service in a timely manner.

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    We estimate an annual private sector burden of 1 min at $36.54/hr 
for an office and administrative support worker to provide written 
notice of the MCO, PIHP, or PAHP's intended action. We estimate that 5 
percent (115,000) of the approximately 2.3 million MCO, PIHP, or PAHP 
enrollees will receive one notice of intended action per year from 
their MCO, PIHP, or PAHP. In aggregate, we estimate 1,916.67 hr 
(115,000 x 1 min) and $70,035 (1,916.67 hr x $36.54/hr).
    In Sec.  438.416, adopted in CHIP through Sec.  457.1260, the state 
must require that MCOs, PIHPs and PAHPs maintain records of grievances 
and appeals. We estimate that approximately 23,000 enrollees (1 
percent) of the approximately 2.3 million MCO and PIHP enrollees file a 
grievance or appeal with their MCO or PIHP. We estimate an annual 
private sector burden of 1 min (per request) at $36.54/hr for an office 
and administrative support worker to record and track grievances. In 
aggregate, we estimate 383 hr (23,000 grievances x 1 min) and $14,007 
(383 hr x $36.54/hr).
58. ICRs Regarding Sanctions (Sec.  457.1270)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to update the 
wage data. No comments were received.
    Section 457.1270 applies subpart I of part 438 to CHIP. In Sec.  
438.722(a) adopted in CHIP through Sec.  457.1270, states are provided 
the option to give MCO, PIHP, PAHP, or PCCM enrollees written notice of 
the state's intent to terminate its MCO, PIHP, PAHP, or PCCM contract. 
Notice may be provided after the state has notified the entity of its 
intention to terminate their contract.
    States already have the authority to terminate MCO, PIHP, PAHP or 
PCCM contracts according to state law and have been providing written 
notice to the MCO, PIHP, PAHP or PCCM enrollees. While it is not 
possible to gather an exact figure, we estimate that 8 states may 
terminate 1 contract per year.
    We estimate an annual state burden of 1 hr at $64.46/hr for a 
business operations specialist to prepare the notice to enrollees. In 
aggregate, we estimate 8 hr (1 hr x 8 states x 1 contract/yr.) and 
$426.56 (8 hr x $64.46/hr). We also estimate 1 hr at $64.46/hr for a 
business operations specialist to prepare the notice. In aggregate, we 
estimate an annual state burden of 8 hr (8 states x 1 hr) and $515.68 
(8 hr x $64.46/hr). To send the notice, we estimate an average 
enrollment of 30,000 beneficiaries and 1 min (per beneficiary) at 
$30.92/hr for a mail clerk. In aggregate we estimate 500 hr (30,000 
beneficiaries x 1 min) and $15,840.00 (500 hr x $30.92/hr).
    Section 438.724, adopted in CHIP through Sec.  457.1270, requires 
that the state give the CMS Regional Office written notice whenever it 
imposes or lifts a sanction. The notice must specify the affected MCO, 
PIHP, PAHP, or PCCM, the kind of sanction, and the reason for the 
state's decision to impose or lift a sanction.
    We anticipate that no more than 15 states will impose or lift a 
sanction each year and that it will take 30 min at $64.46/hr for a 
business operations specialist to give the regional office notice. In 
aggregate, we estimate an annual burden of 7.5 hr (15 states x 30 min) 
and $483.45 (7.5 hr x $64.46/hr).
59. ICRs Regarding Conditions Necessary To Contract as an MCO, PIHP, or 
PAHP (Sec.  457.1280)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted without change. No comments were 
received. The requirements in this section have not changed, rather 
they have been redesignated from another section of part 457, so we do 
not estimate any additional burden.
60. ICRs Regarding Program Integrity Safeguards (Sec.  457.1285)
    The following requirements and burden estimates were set out in the 
proposed rule and are being adopted with minor revisions to update the 
wage data and to revise the number of states affected based on updated 
information from the SEDS. No comments were received.
    Section 457.1285 applies most of subpart H of part 438 to CHIP. 
Section 438.602(a), adopted in CHIP through Sec.  457.1285, details 
state responsibilities for monitoring MCO, PIHP, PAHP, PCCM or PCCM's 
compliance with other sections of part 438, screening and enrollment of 
providers, reviewing ownership and control information, performing 
periodic audits, investigating based on whistleblower information, and 
imposing sanctions as appropriate. States will need to revise their 
policies and implement these activities, as needed.
    We estimate 50 hr at $64.46/hr for a business operations specialist 
to create and/or revise their policies for the activities set out under 
Sec.  438.602(a). In aggregate, we estimate a one-time state burden of 
1,250 hr (25 states x 50 hr) and $80,575.00 (1,250 hr x $64.46/hr). We 
are annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires.
    Section 438.602(b), adopted in CHIP through Sec.  457.1285, 
requires states to screen and enrollee MCO, PIHP, PAHP, PCCM and PCCM 
entity providers in accordance with 42 CFR part 455, subparts B and E. 
States are already required to screen and enroll providers in both FFS 
and managed care in their CHIP programs through Sec.  457.990, so there 
is no additional burden associated with this requirement.
    Section 438.602(e), adopted in CHIP through Sec.  457.1285, 
requires states to conduct or contract for audits of MCO, PIHP, and 
PAHP encounter and financial data once every 3 years. Some states 
already use their EQRO to validate data. If they conduct this task at 
an appropriate frequency, it will incur no additional burden. We 
estimate 12 states already use their EQRO to validate their data, so 
only 21 states may need to take action to meet this requirement. The 
method selected by the state will determine the amount of burden 
incurred. We assume an equal distribution of states selecting each 
method, thus 7 states per method.
    A state using EQRO to validate data on less than an appropriate 
frequency may need to amend their EQRO contract. In this case, we 
estimate 1 hr at $64.46/hr for a business operations specialist. In 
aggregate, we estimate a one-time state burden of 7 hr (7 states x 1 
hr) and $451.22 (7 hr x $64.46/hr). We are annualizing the one-time 
development since we do not anticipate any additional burden after the 
3-year approval period expires.
    A state electing to perform validation internally must develop 
processes and policies to support implementation. In this case, we 
estimate 10 hr at $64.46/hr for a business operations specialist to 
develop policy and 100 hr at $78.32/hr for a computer programmer to 
develop, test, and automate the validation processes. In aggregate, we 
estimate a one-time state burden of 770 hr (7 states x 110 hr) and 
$59,336.20 [7 states x ((10 hr x $64.46/hr) + (100 hr x $78.32/hr))]. 
We are annualizing the one-time development since we do not anticipate 
any additional burden after the 3-year approval period expires.
    For a state electing to procure a vendor, given the wide variance 
in state procurement processes, our burden is conservatively estimated 
at 150 hr for writing a proposal request, evaluating proposals, and 
implementing the selected proposal. We estimate 125 hr at $64.46/hr for 
a business operations specialist to participate in the writing, 
evaluating, and implementing, and 25

[[Page 27805]]

hr at $140.80/hr for a general and operations manager to participate in 
the writing, evaluating, and implementing. In aggregate, we estimate an 
annual state burden of 1,050 hr [7 states x (150 hr)] and $81,042.50 [7 
states x ((125 hr x $64.46/hr) + (25 hr x $140.80/hr))].
    Section 438.602(g), adopted in CHIP through Sec.  457.1285, 
requires states to post the MCO's, PIHP's, and PAHP's contracts, data 
from Sec.  438.604, and audits from Sec.  438.602(e) on their Web site. 
As most of these activities will only occur no more frequently than 
annually, we estimate an annual state burden of 1 hr at $78.32/hr for a 
computer programmer to post the documents. In aggregate, we estimate 25 
hr (25 states x 1 hr) and $1,958 (25 hr x $78.32/hr).
    Section 438.608(a), adopted in CHIP through Sec.  457.1285, 
requires that MCOs, PIHPs, and PAHPs have administrative and management 
arrangements or procedures that are designed to guard against fraud and 
abuse. The arrangements or procedures must include a compliance program 
as set forth under Sec.  438.608(a)(1), provisions for reporting under 
Sec.  438.608(a)(2), provisions for notification under Sec.  
438.608(a)(3), provisions for verification methods under Sec.  
438.608(a)(4), and provisions for written policies under Sec.  
438.608(a)(5).
    The compliance program must include: Written policies, procedures, 
and standards of conduct that articulate the organization's commitment 
to comply with all applicable federal and state standards and 
requirements under the contract; the designation of a Compliance 
Officer; the establishment of a Regulatory Compliance Committee on the 
Board of Directors; effective training and education for the 
organization's management and its employees; and provisions for 
internal monitoring and a prompt and effective response to 
noncompliance with the requirements under the contract.
    We estimate that reviewing their policies and procedures to ensure 
that all of the above listed items are addressed. We estimate this will 
require 5 hr at $64.46/hr for a business operations specialist to 
review and (if necessary) revise their policies and procedures. In 
aggregate, we estimate a one-time private sector burden of 290 hr (58 
MCOs, PIHPs, and PAHPs x 5 hr) and $18,693.40 (290 hr x $64.46/hr). We 
are annualizing the one-time development since we do not anticipate any 
additional burden after the 3-year approval period expires. Section 
438.608(a)(2) and (3), adopted in CHIP through Sec.  457.1285, require 
reporting of overpayments and enrollee fraud. As these will be done via 
an email from the MCO, PIHP, or PAHP to the state and do not occur very 
often, we estimate only 2 hr per year by a business operations 
specialist at $64.46/hr. We estimate an annual burden of 116 hr (58 
MCOs, PIHPs, and PAHPs x 2 hr) and $7, 77.36 (116 hr x $64.46/hr).
    Section 438.608(a)(4), adopted in CHIP through Sec.  457.1285, 
requires the MCO, PIHP, or PAHP to use a sampling methodology to verify 
receipt of services. This typically involves mailing a letter or 
sending an email to the enrollee, we estimate 25 states mail to 100 
enrollees each (25 x 100 = 2,500 mailings) taking 1 min at $30.92/hr 
for a mail clerk. We estimate a total annual aggregate burden for 
private sector of 42 hr (2,500 mailings x 1 min) and $1,298.64 (42 hr x 
$30.92/hr). This burden will be significantly reduced as the use of 
email increases.
    Section 438.608(c) and (d), adopted in CHIP through Sec.  457.1285, 
requires states to include in all MCO, PIHP, and PAHP contracts, the 
process for the disclosure and treatment of certain types of recoveries 
and reporting of such activity. The burden to amend the contracts is 
included in Sec.  457.1201. We estimate the burden to comply with the 
reporting to include 1 hr at $78.32/hr for a computer programmer to 
create the report. In aggregate, we estimate a one-time private sector 
burden of 58 hr (58 MCOs, PIHPs, and PAHPs x 1 hr) and $4,542.56 (58 hr 
x $78.32/hr). We are annualizing the one-time development since we do 
not anticipate any additional burden after the 3-year approval period 
expires. Once developed, the report will be put on a production 
schedule and add no additional burden.

D. Summary of Requirements and Burden Estimates

    Tables 2a, 2b, and 2c set out our annual burden estimates. While 
the annual burden estimates (under Frequency) are unchanged, the one-
time estimates have been annualized by dividing the one-time hour and 
cost figures by 3 to account for OMB's 3-year approval period.
    The burden associated with this final rule is divided amongst four 
Paperwork Reduction Act (PRA) packages. We are finalizing the four 
proposed PRA packages, with some modification. Under our proposal, CMS-
10108 would continue to contain all of part 438, except for those 
provisions related to EQR (Sec. Sec.  438.350, 438.352, 438.354, 
438.356, 438.358, 438.360, 438.362, 438.364, and 438.370), which would 
remain in the separate CMS-R-305. With this final rule, OMB Control 
#0938-0920, CMS-10108 will contain all of part 438 except for subpart 
E, which will be contained in OMB Control #0938-0786, CMS-R-305 and OMB 
Control #0938-New, CMS-10553. Since our original final rule in 2003, 
the provisions related to EQR (Sec. Sec.  438.350, 438.352, 438.354, 
438.356, 438.358, 438.360, 438.362, 438.364, and 438.370) have been 
contained in a separate PRA package (CMS-R-305). We believe this 
continues to be appropriate, given the EQR protocols, which are also 
associated with CMS-R-305, are modified on a different schedule from 
other pieces of this rule. Therefore we will finalize EQR (Sec. Sec.  
438.350, 438.352, 438.354, 438.356, 438.358, 438.360, 438.362, 438.364, 
and 438.370) in OMB Control #0938-0786, CMS-R-305 as proposed.
    We believe that pulling the non-EQR quality provisions (Sec. Sec.  
438.310, 438.320, 438.330, 438.332, 438.334, and 438.340) out of CMS-
10108 will make the impact of any future burden revisions and 
associated subregulatory guidance on these provisions easier to 
describe and present to the public for consideration. As described in 
this rulemaking, some non-EQR provisions of subpart E will have 
associated subregulatory guidance, specifically the Medicaid and CHIP 
QRS (Sec.  438.334) and potentially QAPI (Sec.  438.330; if CMS elects 
to identify a common set of national QAPI performance measures and PIP 
topics). Given this, and based on our experience with a standalone PRA 
package for EQR, we believe that placing the provisions in a separate 
package will allow any burden changes associated with future guidance 
to more clearly be presented to the public. We previously proposed that 
the burden for proposed part 431 subpart I would be contained in a new 
PRA package (OMB Control# 0938-New, CMS-10553); as we are withdrawing 
proposed part 431 subpart I, CMS-10553 will instead contain the non-EQR 
subpart E provisions (Sec. Sec.  438.310, 438.320, 438.330, 438.332, 
438.334, and 438.340). We do not believe this revision will have any 
negative impacts on the public, as it should serve only to make it 
easier to assess the impact of future subregulatory guidance.
    We proposed that the CHIP managed care regulation burden be in a 
new PRA package, CMS-10554; we are finalizing the CHIP burden in this 
package as proposed.

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E. Exempt ICRs

    No comments were received on these burden estimates.
1. Administrative Actions
    While the requirements under Sec. Sec.  431.220(a)(5) and (6), 
431.220(b), 438.710(b)(2), 438.730(b), and 457.1270(a), (b), and (c) 
are subject to the PRA, since the information collection requirements 
are associated with an administrative action (5 CFR 1320.4(a)(2) and 
(c)), they are exempt from the requirements of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.)
    Section 431.220(a)(5) and (6) would add PAHP enrollees as eligible 
for a state fair hearing as permitted in subpart B of 42 CFR part 438. 
Section 431.220(b) prescribes procedures for an opportunity for a 
hearing if the state agency or non-emergency transportation PAHP takes 
action to suspend, terminate, or reduce services, or an MCO, PIHP or 
PAHP takes action under subpart.
    Before imposing any of the sanctions specified in subpart I, Sec.  
438.710(a) would require that the state give the affected MCO, PIHP, 
PAHP or PCCM written notice that explains the basis and nature of the 
sanction. Section 438.710(b)(2) states that before terminating an 
MCO's, PIHP's, PAHP's or PCCM's contract, the state would be required 
to: (1) Give the MCO or PCCM written notice of its intent to terminate, 
the reason for termination, the time and place of the hearing; (2) give 
the entity written notice (after the hearing) of the decision affirming 
or reversing the proposed termination of the contract and, for an 
affirming decision, the effective date of termination; and (3) give 
enrollees of the MCO or PCCM notice (for an affirming decision) of the 
termination and information, consistent with Sec.  438.10, on their 
options for receiving Medicaid services following the effective date of 
termination.
    Section 438.730(b) would require that if CMS accepts a state 
agency's recommendation for a sanction, the state agency would be 
required to give the MCO written notice of the proposed sanction. 
Section 438.730(c) would require that if the MCO submits a timely 
response to the notice of sanction, the state agency must give the MCO 
a concise written decision setting forth the factual and legal basis 
for the decision. If CMS reverses the state's decision, the state must 
send a copy to the MCO.
    Section 457.1270 would apply subpart I (Sanctions) of part 438 to 
CHIP. Within subpart I, Sec.  438.710(a) would require that the state 
provide the affected entity with timely written notice of the basis of 
the sanction. Section 438.710(b) would require that the state provide 
an entity a pre-termination hearing. If CMS accepts a state agency's 
recommendation for a sanction, Sec.  438.730(b) would require that the 
agency provide the MCO, PIHP or PAHP written notice of the proposed 
sanction. If the MCO submits a timely response to the notice of 
sanction, Sec.  438.730(c) would require that the state agency provide 
the MCO, PIHP or PAHP with a concise written decision setting forth the 
factual and legal basis for the decision. If we reverse the state's 
decision, the state must send a copy to the affected MCO, PIHP or PAHP.
2. Fewer Than 10 Respondents
    While the requirements under Sec. Sec.  438.8(m), 438.70(a), 
438.102(a)(2), 438.340(a), 438.350, 438.360(c), 438.724, and 438.818(d) 
are subject to the PRA, in each instance we estimate fewer than 10 
respondents. Consequently, the information collection requirements are 
exempt (5 CFR 1320.3(c)) from the requirements of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    Section 438.8(m) would require the MCO, PIHP, or PAHP to 
recalculate its MLR for any year in which a retroactive capitation 
change is made. In our experience working with states on rate setting, 
retroactive adjustments are not a common practice; therefore, we 
estimate that no more than three plans per year may have to recalculate 
their MLR.
    Section 438.70(a) would require that states have a process to 
solicit and address viewpoints from beneficiaries, providers, and other 
stakeholders as part of the design, implementation, and oversight of 
the managed LTSS program. Based on our experience approving MLTSS 
programs and the number of states that have not yet implemented, we 
estimate no more than 3 states per year would elect to move to a 
managed LTSS program.
    Section 438.102(a)(2) specifies that MCOs, PIHPs, and PAHPs are not 
required to cover, furnish, or pay for a particular counseling or 
referral service if the MCO, PIHP, or PAHP objects to the provision of 
that service on moral or

[[Page 27829]]

religious grounds; and that written information on these policies is 
made available to: Prospective enrollees, before and during enrollment; 
and current enrollees, within 90 days after adopting the policy for an 
any particular service. Based on our experience reviewing and approving 
plan contracts, we believe the burden associated with this requirement 
affects no more than 3 MCOs or PIHPs annually since it applies only to 
the services they discontinue providing on moral or religious grounds 
during the contract period, which varies in length and can be as short 
as one year. PAHPs are excluded from this estimate because they 
generally do not provide services that would be affected by this 
provision.
    Section 438.340(a) requires each state that contracts with an MCO, 
PIHP, PAHP, or PCCM entity (described in Sec.  438.310(c)(2)) to write 
and implement a quality strategy. We estimate that there are three 
states that contract only with PAHPs and two states that contract only 
with PCCM entities (described in Sec.  438.310(c)(2)), and thus do not 
already have a quality strategy (the other states with PAHPs and PCCM 
entities (described in Sec.  438.310(c)(2)) also contract with MCOs 
and/or PIHPs, and thus, already have an initial quality strategy). We 
estimate that these five states will draft an initial quality strategy.
    Section 438.350 adds PAHPs and PCCM entities (described in Sec.  
438.310(c)(2)) to the EQR process. We estimate that there are three 
states with PAHPs and two states with PCCM entities (described in Sec.  
438.310(c)(2)) that do not currently have an EQRO contract and will 
need to enter into a contract with an EQRO.
    Section 438.360(c) requires states to document, in the quality 
strategy required at Sec.  438.340, which mandatory EQR-related 
activities it will apply the non-duplication provisions to, and why it 
believes these activities are duplicative. Given that this is already 
standard practice for the 37 states that currently contract with MCOs 
and/or PIHPs, only the three states that contract only with PAHPs and 
the two states that contract only with PCCM entities (described in 
Sec.  438.310(c)(2)) will have to revise their policies and procedures 
to include this in their quality strategy.
    Section 438.724 would require that the state provide written notice 
to their CMS Regional Office whenever it imposes or lifts a sanction on 
a PCCM or PCCM entity. Given the limited scope of benefits provided by 
a PCCM or PCCM entity and the Regional offices' experience, we 
anticipate that no more than 3 states may impose or lift a sanction on 
a PCCM or PCCM entity in any year.
    Section 438.818(d) would have required states new to managed care 
and not previously submitting encounter data to MSIS to submit an 
Implementation plan. There are currently only 8 states that do not use 
MCOs thus these would be the only states that may have to submit an 
Implementation plan should they adopt managed care in the future. This 
estimate is no longer needed as this provision is not being finalized.
3. Usual and Customary Business Practices
    Section 433.138(e)(1) would make a technical correction addressing 
state Medicaid agencies' review of claims with trauma codes, to 
identify instances where third party liability (TPL) may exist for 
expenditures for medical assistance covered under the state plan. The 
correction would remove references to the International Classification 
of Disease, 9th edition, Clinical Modification Volume 1 (ICD-9-CM) by 
replacing the references with a general description of the types of 
medical diagnoses indicative of trauma. States would use the 
International Classification of Disease that they are using at the time 
of claims processing. There is no additional cost to the state related 
to the proposed changes to Sec.  433.138(e) because the proposed 
changes do not require any action by the state, if the state wishes to 
retain their usual and customary editing for the same types of 
traumatic injuries currently identified with ICD-9-CM.
    While the requirements under Sec. Sec.  438.10(c)(7), 
438.208(b)(2), 438.208(b)(5), 438.210(b), 438.214, 438.360(c), 
438.406(b)(5), 438.408(b)(2) and (3), 438.408(f)(1) and (2), and 
438.416(b) and (c) are subject to the PRA, we believe the associated 
burden is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). We 
believe that the time, effort, and financial resources necessary to 
comply with the aforementioned requirements would be incurred by 
persons during the normal course of their activities and, therefore, 
should be considered usual and customary business practices.
    Section 438.10(c)(7) would add PAHPs and PCCMs to the managed care 
entities that must have mechanisms in place to help enrollees and 
potential enrollees understand the requirements and benefits of managed 
care. These practices are customarily performed to maintain and improve 
market share.
    Section 438.208(b)(2) would require that MCOs, PIHPs and PAHPs 
coordinate an enrollee's care between settings or with services 
received through a different MCO, PIHP, PAHP and FFS. Section 
438.208(b)(2)(i) would require discharge planning which has been a long 
standing industry practice since managed care plans consistently 
require authorization for all inpatient and facility care. Coordination 
of care, including discharge planning, is fundamental to managed care 
and is not unique to Medicaid. It is customarily performed by all 
managed care insurers, particularly for high-risk or high-cost 
populations.
    Section 438.208(b)(5) would require providers to maintain a record 
according to medical industry accepted professional standards. Record 
maintenance is customarily performed as a condition of licensure.
    Section 438.210(b) would require contracts with MCOs, PIHPs, or 
PAHPs and its subcontractors to have written policies and procedures 
for the processing of requests for initial and continuing 
authorizations of services. The burden associated with this requirement 
is the time required to develop the policies and procedures which is 
standard industry practice for managed care plans. Building and 
maintaining a network is fundamental to managed care and is not unique 
to Medicaid. It is customarily performed by all managed care insurers.
    In Sec.  438.214, each state must ensure, through its contracts, 
that each MCO, PIHP, or PAHP implements written policies and procedures 
for the selection and retention of providers. Since all managed care 
programs utilize provider networks, this is industry standard practice.
    Section 438.406(b)(5) would modify the language for evidence 
standards for appeals to mirror the private market evidence standards. 
This aligns the text with private market requirements but does not 
alter the meaning. Based on our experience approving managed care plan 
contracts, most insurers offer more than one line of business, and 
therefore we believe this will make Medicaid consistent with usual and 
customary business practices.
    Section 438.408(b)(2) would change the timeframe an entity has to 
reach a determination from 45 days to 30 days to align with Medicare. 
Most insurers offer more than one line of business, and therefore we 
believe this timeframe will allow MCOs, PIHPs, and PAHPs to be 
consistent with their usual and customary business practices and reduce 
their burden. Section 438.408(b)(3) would change the timeframe an 
entity has to reach a determination in an expedited appeal from 3 days 
to 72 hr to align with

[[Page 27830]]

Medicare and the private market. Based on our experience approving plan 
contracts, most insurers offer more than one line of business, and 
therefore we believe this timeframe will make Medicaid consistent with 
usual and customary business practices.
    Section 438.408(f)(1) and (2) would require that an enrollee 
exhaust the appeals process before proceeding to the state fair hearing 
process, and change the timeframe in which a beneficiary must request a 
state fair hearing to 120 days. MCOs, PIHPs, and PAHPs would no longer 
have to maintain an appeal and a fair hearing simultaneously which will 
decrease administrative burdens. The changing of the timeframe to 
request a state fair hearing from ``not less than 20 or in excess of 90 
days'' to 120 days aligns with the private market. Based on our 
experience approving plan contracts, most insurers offer more than one 
line of business, and therefore we believe aligning these timeframes 
will make Medicaid consistent with their usual and customary business 
practices.
    Section 438.416(b) and (c) would set forth a standard for the 
minimum types of information an entity must record during the appeals 
process and how that information must be stored. This standard aligns 
with the standards in the private market. Based on our experience 
approving plan contracts, most insurers offer more than one line of 
business, and therefore, we believe aligning record keeping standards 
will make Medicaid consistent with usual and customary business 
practices.
    Comment: We received one comment on the COI burden estimate in 
Sec.  438.818(a)(2): ``Encounter data be validated prior to its 
submission. 1,350 hr [9 states x (150 hr)] and $88,722 [9 states x 
((125 hr x $53.32/hr) + (25 hr x $127.72/hr) The commenter believed CMS 
drastically undervalued the maintenance, reconciliation, modification, 
and monitoring it takes to accurately submit this data, besides ongoing 
license fees.
    Response: This estimate was one of three addressed in the COI as 
possible implementation options for Sec.  438.818(a)(2) and offers an 
estimate for procuring a non-EQRO vendor for the data validation. We 
disagree that the estimate under values the effort required given the 
wide variation in state procurement processes. Additionally, we believe 
most states electing to utilize an outside vendor for this activity 
will opt to use their EQRO vendor as those expenses receive 75 percent 
FFP. Additionally, all states contracting with managed care plans 
should currently be collecting and validating encounter data. Depending 
on how robust those validation methods are currently, some states may 
not need to alter their processes based on proposed Sec.  
438.818(a)(2). We decline to revise this estimate.

VI. Regulatory Impact Analysis

A. Statement of Need

    This final rule modernizes the Medicaid managed care regulations 
recognizing changes in the usage of managed care delivery systems since 
the release of the final rule in 2002. As Medicaid managed care 
programs have developed and matured in the intervening years, states 
have taken various approaches to implementing part 438. This has 
resulted in inconsistencies and, in some cases, less than optimal 
results. To improve consistency and adopt policies and practices from 
states that have proven the most successful, we are finalizing 
revisions to strengthen beneficiary protections, support alignment with 
rules governing managed care in other public and private sector 
programs, strengthen actuarial soundness and the accountability of 
rates paid in the Medicaid managed care program, and implement 
statutory provisions issued since 2002.
    According to the 2014 Actuarial Report on the Financial Outlook for 
Medicaid, total Medicaid outlays in federal FY 2013 exceeded $457 
billion; $265 billion, or 58 percent represented federal spending, and 
$192 billion, or 42 percent represented state spending.\14\ States have 
continued to expand the use of managed care in the past decade, not 
only to new geographic areas but to more complex populations, including 
seniors, persons with disabilities, and those who need LTSS. Today, the 
predominant form of managed care in Medicaid is capitated risk-based 
arrangements--similar in structure to some arrangements in the private 
insurance market. Coordination and alignment with the private insurance 
market will improve operational efficiencies for states and managed 
care plans and improve the experience of care for individuals moving 
between insurance coverage options. Total Medicaid managed care 
spending (federal and state) exceeded $132 billion in 2013,\15\ with 
expenditures rising annually as new beneficiaries and programs move 
into a managed care delivery system. It is CMS' responsibility to 
ensure that these dollars are spent wisely, and that there is adequate 
funding to support the delivery of required services to beneficiaries 
and to avoid wasting state and federal tax dollars.
---------------------------------------------------------------------------

    \14\ http://www.medicaid.gov/medicaid-chip-program-information/by-topics/financing-and-reimbursement/downloads/medicaid-actuarial-report-2014.pdf.
    \15\ CMS, Financial Management Report--Base Payments, 2013.
---------------------------------------------------------------------------

    Additionally, the prevalence of MLTSS being delivered through a 
risk-based capitated system has increased from fewer than 8 programs in 
2004 to 20 programs in 2014. Beneficiaries using MLTSS are among the 
most vulnerable and often require enhanced protections to assure health 
and welfare. This regulation codifies these necessary beneficiary 
protections in MLTSS. The changes finalized for rate setting, MLR, 
encounter data, and reporting, will support and reflect the increased 
efforts of states and managed care plans to provide more comprehensive, 
coordinated, and effective care while achieving better health outcomes.
    The Congress established CHIP in 1997 through the passage of the 
Balanced Budget Act (BBA) and reauthorized it in 2009 with the passage 
of the CHIPRA. Since CHIP was established, participation has grown 
steadily, and the rate of uninsured children has been reduced by half. 
The most recent data indicate that more than 87 percent of eligible 
children are enrolled in CHIP or Medicaid. Managed care has always been 
a large part of CHIP, because the program was established in an era of 
increased use of managed care in all health care sectors and the 
flexibility granted to states in administering the program. Many states 
enroll all or nearly all of their CHIP population in managed care 
plans. At the same time, CHIP has historically had few regulations 
related to the use of managed care.
    When the Congress reauthorized CHIP in 2009 in section 403 of 
CHIPRA, it applied a number of the Medicaid managed care provisions in 
section 1932 of the Act to CHIP. In response, we released two State 
Health Official (SHO) letters 09-008 and 09-013, issued on August 31, 
2009 and October 21, 2009, respectively, which provided initial 
guidance on the implementation of section 403 of CHIPRA. (SHO #09-008 
is available at http://downloads.cms.gov/cmsgov/archived-downloads/SMDL/downloads/SHO083109a.pdf. SHO #09-013 is available at http://www.medicaid.gov/Federal-Policy-Guidance/downloads/SHO102109.pdf.) This 
final rule builds on that guidance. Where practical, the rule aligns 
CHIP managed care standards with those of the Marketplace and Medicaid, 
ensuring consistency across programs. Consistency has the benefit of 
creating efficiencies for both

[[Page 27831]]

plans and beneficiaries, including operational efficiencies for plans 
from using similar rules and smoother transitions between programs for 
beneficiaries.
    The BBA established quality standards for Medicaid managed care 
programs: A quality assessment and improvement strategy; and an 
external, independent review. While these standards initially applied 
only to MCOs, the application of several of them has spread to PIHPs 
(via the regulations at part 438, subparts D (Quality Assessment and 
Performance Improvement, effective on August 13, 2002 (67 FR 40989)) 
and E (External Quality Review, effective on March 25, 2003 (68 FR 
3586)) and to CHIP managed care programs (per the CHIPRA).
    Under this final rule, we restructure the quality provisions of 
part 438 into a single subpart, subpart E, and apply these provisions 
to states contracting with MCOs, PIHPs, PAHPs, and PCCM entities 
(described in Sec.  438.310(c)(2)). States that utilize one or more of 
these four managed care delivery systems will require their plans to 
operate a QAPI program, will themselves operate a managed care quality 
strategy, and will contract with a qualified EQR organization to 
conduct an annual EQR. States will report publicly on the accreditation 
status of their contract MCOs, PIHPs, and PAHPs; states will also issue 
an annual quality rating for each of these plans using the state's 
Medicaid manage care quality rating system. The changes finalized in 
this rule-making will further align Medicaid with other healthcare 
programs, specifically Medicare and the Marketplace. The improvements 
to Medicaid and CHIP managed care quality finalized in this rule give 
states additional tools to evaluate and improve the care received by 
beneficiaries.
    For all of these reasons, the current regulatory framework is no 
longer the most appropriate or efficient to achieve program goals. We 
believe that it is necessary to modernize the Medicaid and CHIP managed 
care regulations to support health care delivery system reform, improve 
population health outcomes, and improve the beneficiary experience in a 
cost effective and consistent manner in all states.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the 
Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), 
Executive Order 13132 on Federalism (August 4, 1999) and the 
Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). We estimate that this rule is ``economically significant'' as 
measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we have prepared a RIA 
that to the best of our ability presents the costs and benefits of this 
rule. The numbers presented in this RIA are rounded depending on the 
level of precision in the data used to generate them. Specifically, all 
COI costs are rounded to $0.1 million while transfers are rounded to 
the nearest $100 million. This difference also allows us to display the 
smaller numbers in the COI costs, which would reflect zero if rounded 
to the nearest $100 million.
    All burden estimates in this final rule utilized 2012 data 
submitted by states to the MSIS. That data reflected almost 63,000,000 
beneficiaries enrolled in 606 MCOs, PIHPs, PAHPs, or PCCMs in 42 states 
(335 MCOs, 176 PIHPs, 41 PAHPs, 20 NEMT PAHPs, 25 PCCMs, and 9 PCCM 
entities). For CHIP, burden estimates utilized 2015 data submitted by 
states to the SEDS. We estimate that there are 62 plans that states use 
to contract with CHIP separately from their Medicaid programs as a 
result of discussions with states since the publication of the proposed 
rule. Utilizing SEDS data available as of December 2015, there are 25 
states with approximately 2.3 million children enrolled in managed care 
in separate CHIP programs.
    Tables 3 and 4 show the overall estimates of the financial impact 
of this final rule. These tables and analyses use administrative burden 
estimates from the Paperwork Reduction Act documentation as well as any 
other quantifiable and qualitative benefits and costs when available. 
Table 3 divides the overall cost estimates into federal costs, state 
costs, and private sector costs with high and low estimates as 
appropriate. Table 4 divides the overall transfer estimates into 
federal and state transfers with high and low estimates as appropriate. 
Utilizing burden estimates from section V of this final rule (COI) and 
estimated transfers, federal, state, and private sector costs and 
transfers were derived by applying the appropriate FMAP to the 
corresponding burdens in section V of this final rule. For the 
revisions in part 438, we apply a weighted FMAP of 58.44 percent 
(weighted for enrollment) to estimate the federal share of private 
sector costs. This is done to account for private sector costs that are 
passed to the federal government through the managed care capitation 
rates. For part 457, we apply an enhanced FMAP of 93.9 for 2016 through 
2019 and an enhanced FMAP of 71.5 for 2020 for both state and private 
sector costs. These represent the average CHIP FMAP in the respective 
years under current law. Federal CHIP funding is capped and is 
currently appropriated through 2017; therefore, federal CHIP 
expenditures will not exceed the total allotments described in section 
2104(a) of the Act.
    Table 3 separates the overall costs by part 438, which represents 
Medicaid managed care and part 457, which represents CHIP. As shown in 
Table 3, the total projected cost associated with this final rule is a 
cumulative $91.7 million in the first year for revisions to part 438, 
and a cumulative $22.1 million in the first year for revisions to part 
457, for a total cost of a cumulative $113.8 million for all revisions 
in the first year. Table 4 represents the overall transfer estimates 
for part 438 only, as part 457 has no estimated transfers. As shown in 
Table 4, the total estimated

[[Page 27832]]

transfers associated with this final rule are $0 in the first year.
    The COI costs estimated for some of the provisions are based on the 
number of enrollees. As such, as enrollment grows each year, the cost 
for these provisions will grow accordingly. For this analysis, we used 
the projected average enrollment growth rate for Medicaid of 3.3 
percent \16\ for Medicaid managed care enrollment to trend cost 
burdens. Recognizing the success that states have had enrolling 
eligible children in CHIP (more than 87 percent of eligible children 
enrolled in CHIP or Medicaid) \17\ and the current prevalence of 
managed care in the program, we used a 3 percent growth rate for CHIP 
managed care enrollment. The burdens estimated for the quality 
components (part 438 subpart E) are not associated with enrollment, and 
therefore, do not display any variable costs.
---------------------------------------------------------------------------

    \16\ http://www.medicaid.gov/medicaid-chip-program-information/by-topics/financing-and-reimbursement/downloads/medicaid-actuarial-report-2013.pdf.
    \17\ Genevieve M. Kenney, Nathaniel Anderson, Victoria Lynch. 
Medicaid/CHIP Participation Rates Among Children: An Update. 
September 2013. Available at http://www.urban.org/sites/default/files/alfresco/publication-pdfs/412901-Medicaid-CHIP-Participation-Rates-Among-Children-An-Update.pdf.
---------------------------------------------------------------------------

    This RIA includes the administrative costs (wage and labor) related 
to implementing and operating a Medicaid managed care delivery system, 
as well as non-administrative benefit and cost estimates when 
available. The burden estimates presented in section V of this final 
rule provide the detail supporting the summary COI burden estimates 
presented in this RIA.
[GRAPHIC] [TIFF OMITTED] TR06MY16.023


[[Page 27833]]


[GRAPHIC] [TIFF OMITTED] TR06MY16.024

    All state Medicaid programs receive a federal matching rate of at 
least 50 percent for administrative expenses and 50 to 73 percent 
(determined individually by state) for covered service expenses, with 
exceptions for certain services and eligibility groups. State CHIP 
programs receive a higher federal funding rate, ranging from 88 to 100 
percent for 2016 through 2019 and ranging from 65 to 82 percent for 
2020; states receive the same federal funding rate for administrative 
expenses, but they are capped at 10 percent of a state's total CHIP 
expenditures. The Medicaid managed care plans are paid actuarially 
sound capitation rates to cover the costs of fulfilling their 
obligations under their contract. These rates are included in the 
expenditures by the state and subsequently submitted to CMS for federal 
matching payments at the state's assigned rate. This is reflected in 
Table 3 in the ``Private Sector'' row. State expenditures for EQR and 
EQR-related activities performed by EQROs for MCOs with contracts under 
section 1903(m) of the Act are eligible for a federal matching rate of 
75 percent; EQR on other types of managed care entities or EQR-related 
activities conducted by non-EQROs are eligible for a 50 percent federal 
matching rate. CHIP EQR activities are considered administrative 
activities, which receive the CHIP federal funding rate, and count 
towards the administrative cap.
    Table 5 shows the estimate of the impact for the COI costs of this 
final rule, divided into fixed and variable costs. Fixed costs are 
those which do not change with the number of enrollees while variable 
costs change with the number of enrollees.
[GRAPHIC] [TIFF OMITTED] TR06MY16.025


[[Page 27834]]


1. Cost Estimates by Guiding Principles
    The principles discussed below guided the policy development and 
changes made in the final rule. These guiding principles and finalized 
regulatory changes support the coordination and integration of health 
care, promote effective forms of information sharing, and require 
transparency on cost and quality information to support greater overall 
accountability in the Medicaid and CHIP programs. Detailed COI burden 
estimates can be found in section V of this final rule. This section 
details the significant COI costs and transfers related to benefits and 
costs associated with this final rule.
2. Setting Actuarially Sound Rates and Other Payment and Accountability 
Improvements
    This guiding principle seeks to provide more data, analytical 
rigor, documentation, and transparency in the managed care rate setting 
process and includes setting actuarially sound capitation rates and 
program integrity. The estimated first-year COI costs associated with 
the provisions under this guiding principle account for a cumulative $1 
million of the total estimated first-year burden for the revisions to 
part 438 and part 457 (detailed burden estimates can be found in the 
COI section of this final rule at sections IV.C.2 and IV.C.3 for rates 
and IV.C.36 and IV.C.37 for program integrity).
    The final rule also contains requirements related to setting 
actuarially sound capitation rates in sections Sec.  438.4 through 
Sec.  438.7. Many of these requirements will codify current policy on 
developing capitation rates for Medicaid managed care plans. Other 
requirements set standards for actuaries developing the capitation 
rates, specify requirements for data and information that must be 
included in the actuarial certification of the rates, and describe the 
CMS process for reviewing and approving the rates. As such, we believe 
that many of these provisions are unlikely to have a direct effect on 
the actual capitation rates or future Medicaid expenditures. To the 
extent that these new standards or requirements do have an effect on 
capitation rates or Medicaid expenditures, we believe this could lead 
to increases in some cases and decreases in other cases in the 
capitation payment rates and Medicaid expenditures.
    We believe that the combination of the new finalized requirements 
related to actuarial soundness and to no longer allow states to certify 
rate ranges and to require states to certify specific capitation rates 
may have some financial impact. Currently, 40 states and the District 
of Columbia have at least one managed care program as part of their 
Medicaid program. Of these, 26 states and the District of Columbia 
currently certify rate ranges instead of rates for at least one managed 
care program in the state (Arkansas; California; Colorado; Delaware; 
District of Columbia; Georgia; Idaho; Indiana; Iowa; Kansas; Kentucky; 
Louisiana; Maryland; Massachusetts; Minnesota; Missouri; Nebraska; New 
Mexico; New York; North Carolina; North Dakota; Oregon; Pennsylvania; 
Tennessee; Utah; Virginia; and West Virginia). The certified rate 
ranges in many cases can be large. Based on our review of the most 
recent actuarial certifications in states that use rate ranges, the 
width of the rate range is 10 percent or smaller in 14 states (that is, 
the low end and the high end of the range are within 5 percent of the 
midpoint of the range), but in some states the ranges may be as wide as 
30 percent (that is, the low end and the high end are within 15 percent 
of the midpoint of the range). In addition, most states tend to set the 
contracted capitation payment rates toward the lower end of the rate 
range.
    For states that currently use relatively narrower rate ranges 
(which we would generally define as 10 percent or less), we believe 
that the states will be able to meet the requirements and reasonably 
set rates that will be equivalent to those at the low end of the rate 
ranges (if the states were still able to certify a rate range). For 
states with relatively wider rate ranges (those that are greater than 
10 percent), we believe that these states may not be able to set rates 
equivalent to the current low end of the rate range. In general, our 
opinion is that in cases where the rates would be more than 5 percent 
below the midpoint of the rate ranges it will be more difficult for a 
state to certify that rate as actuarially sound (and at the same time 
meet all of the other actuarial soundness requirements).
    To estimate the high end of the range of the potential financial 
impact, we assumed that in states that had rate ranges wider than 10 
percent and set rates at the low end of the rate range, that future 
Medicaid MCO, PIHP, and PAHP premiums would increase 2.5 percent (that 
is, roughly the average across all states of how much the low end of 
the rate range would need to increase to bring the width of the rate 
range to about 10 percent). We also included states for which the rate 
certification provided no information about the actual contracted 
capitation payment rates. For states with wide rate ranges but that 
paid rates at different points within the rate ranges, we assumed that 
the rates would increase by 1.25 percent (that is, half of the increase 
in rates for states that paid at the low end of the rate range). We 
assumed no impact on states with relatively narrower rate ranges (10 
percent or less).
    The newly finalized requirements related to actuarial soundness and 
to no longer allow states to certify rate ranges and to require states 
to certify specific capitation rates are estimated to increased 
projected Medicaid managed care expenditures by $3.7 billion from 2016 
to 2020, or about 0.3 percent overall of about $1.4 trillion in 
projected Medicaid expenditures on MCOs, PIHPs, and PAHPs over the 5-
year period. These estimates will be an increase of about 1.5 percent 
in costs in states assumed to be affected by this change. We believe 
that these estimates are a reasonable upper bound on the projected 
effect of the final rule.
    In addition, we believe that there may be cases where these changes 
would reduce capitation rates and Medicaid expenditures. In particular, 
there are some states that make significant retroactive changes to the 
contracted rates at or after the end of the rating period. We do not 
believe that these changes are made to reflect changes in the 
underlying assumptions used to develop the rates (for example, the 
utilization of services, the prices of services, or the health status 
of the enrollee), but rather believe that they are used to provide 
additional reimbursements to the plans or to some providers. We believe 
that the requirements for actuarial soundness and certifying the 
specific capitation rates would limit these types of changes and may 
result in some reduction in Medicaid expenditures.
    To estimate the high end of the range of the potential financial 
impact, we assumed that in states that we are aware of that make these 
types of changes to the capitation rates, an amount equal to 50 percent 
of the difference between paying MCOs, PIHPs, and PAHPs at the low end 
and the high end of the rate ranges would not be paid to the plans. 
Limiting these changes by states decreased projected Medicaid managed 
care expenditures by $8.7 billion from 2016 to 2020, or about 0.6 
percent of about $1.4 trillion in projected expenditures on MCOs, 
PIHPs, and PAHPs over those 5 years. We believe that these estimates 
are a reasonable upper bound on the projected effect of the final 
requirements.

[[Page 27835]]

    Thus, we believe that the effects of these finalized Medicaid 
managed care actuarial soundness requirements and the requirement to 
certify the capitation rates could increase expenditures as much as 
$3.7 billion from 2016 to 2020 and could decrease expenditures as much 
as $8.7 billion from 2016 to 2020. We believe that these estimates 
reflect reasonable upper and lower bounds on the potential effect of 
these changes in the final regulation. Assuming that these changes in 
the regulation go into effect mid-way through 2016, we estimate that 
the changes related to actuarial soundness requirements and certifying 
the capitation rates would have the following effects shown in Table 6.
[GRAPHIC] [TIFF OMITTED] TR06MY16.026

    It is possible that the impacts could be more or less than 
estimated here. More or fewer states may need to adjust capitation 
rates than we have assumed here. In particular, it is possible that 
states with relatively narrower ranges may decide that the capitation 
rates would still need to be higher than what would have been the low 
end of the rate range previously. States that use rate ranges as wide 
as 10 percent may still be affected by these changes. In addition, 
states may adjust their capitation rates to a greater or lesser extent 
than we have assumed here. While we believe that the final changes 
related to rate setting may be more likely to affect states that 
currently use relatively wide rate ranges, it is also possible that 
this may affect other states, including those that do not use rate 
ranges at all.
    In addition, for states that historically have made significant 
changes to capitation rates within the rate ranges at the end or after 
the end of the rating period, those states may adjust their rate 
setting approaches as well. The payments might be closer to or farther 
from the final payments than we have estimated. Finally, these 
projections rely on the data, assumptions, and methodology used to 
develop the President's FY 2017 Budget projections for Medicaid. 
Changes in enrollment, health care costs, and the use of managed care 
plans within Medicaid may differ from these projections and may lead to 
greater or lesser Medicaid MCO, PIHP, and PAHP expenditures.
    We received the following comment on the RIA.
    Comment: We received one comment on Table 6. The commenter believed 
that codifying the current policy on developing capitation rates for 
Medicaid managed care plans and requiring states to certify individual 
rates will be a significant overall burden to both states and MCOs. The 
commenter encouraged CMS to simplify its approach and eliminate any 
duplication of review and requirements and believed the burden will 
increase the time for review by the state and the state's consulting 
actuaries each year. The commenter also believed this proposal may 
increase the data requirements. The commenter stated it was difficult 
to estimate the burden without the details of what this change will 
impact.
    Response: The projected financial effects estimated in Table 6 were 
based on information gathered from existing state contracts and rate 
documentation submitted in the previous 2 years. We agree that the 
effects of the final rule will vary by state depending on the state's 
current processes but we believe the estimates accurately reflect the 
most current information available. We decline to revise this estimate.
3. Program Integrity
    Another aspect of this rule that we evaluated under this principle 
was enhancements to program integrity. We believe that many of these 
program integrity activities are currently being performed by states 
and MCOs, PIHPs, and PAHPs. For program integrity activities that would 
be new or expanded under the final rule, there is very limited 
information on the effect that program integrity activities in general 
have on Medicaid expenditures. The total estimated burden on states and 
managed care plans to implement the finalized provisions is $471,691.30 
(detailed in the Collection of Information). The lack of information is 
especially true for specific program integrity activities. While we 
believe these new activities may lead to some additional recoveries 
from plans, providers, or other individuals and may also deter entities 
from committing fraud or violating program requirements, it is 
difficult to determine the financial impacts of these activities and we 
believe that any financial impact is unknown. Therefore, we are not 
estimating the financial impact on future Medicaid expenditures.

[[Page 27836]]

4. Alignment With Other Insurers
    This guiding principle seeks to align Medicaid and CHIP managed 
care requirements with the Marketplace or MA to better streamline the 
beneficiary experience and to reduce operational burdens on health 
plans across publicly-funded programs and the private market. This 
guiding principle covers the regulatory topics of marketing, appeals 
and grievances, MLR, and standard contract provisions. As shown in 
Table 7, the COI costs associated with the provisions under this 
principle account for a cumulative $6.9 million in the first year for 
the revisions to part 438.
[GRAPHIC] [TIFF OMITTED] TR06MY16.027

    Similarly, as shown in Table 8, the COI costs associated with 
implementing the provisions under this principle account for a 
cumulative $10.1 million in the first year for the revisions to part 
457.

[[Page 27837]]

[GRAPHIC] [TIFF OMITTED] TR06MY16.028

5. Medical Loss Ratio
    As an increasing and more diverse set of Medicaid services are 
being delivered through managed care, good measurement systems are 
increasingly important to ensure that Medicaid funding is used 
prudently and that capitation rates are sufficiently based on the 
expenses associated with services. The implementation of MLR-related 
requirements are an integral part of the overall financial 
accountability aspects of the proposal and would align Medicaid and 
CHIP with the private health insurance market, as well as with MA. MLR 
reporting is a valuable tool to ensure that capitation rates for MCOs, 
PIHPs, and PAHPs are actuarially sound and adequately based on 
reasonable expenditures for covered services. Acknowledging that basis 
for an MLR requirement, there are four benefits to having a common 
national standard for the calculation, reporting and use of MLR: (1) It 
will provide greater transparency for the use of Medicaid funding; (2) 
it will allow comparisons across states and facilitate better rate 
setting; (3) it will facilitate better comparisons to MLRs in MA and 
the private health market; and (4) it will reduce the administrative 
burden on managed care plans by providing a consistent approach to 
ensuring financial accountability for plans with multiple product lines 
and/or operating in multiple states. The final provisions in Sec. Sec.  
438.4, 438.5, 438.8, 457.1203 and 457.1205 require MCOs, PIHPs, and 
PAHPs to calculate, report, and use a MLR in the development of 
capitation rates. The estimated first-year COI cost for the provisions 
in part 438 is a cumulative $5 million (detailed burden estimates can 
be found in the COI section of this final rule at section V.C.4 for 
MLR). The total estimated first-year COI cost associated with 
implementing the final MLR provisions of part 457 is a cumulative $0.5 
million.
    We finalized standards that require the states to calculate and 
report the MLRs for Medicaid MCOs, PIHPs, and PAHPs in Sec.  438.4 and 
Sec.  438.5, and to add new Sec.  438.8 and Sec.  438.74, as well as 
incorporate an MLR assumption in the rate setting process. These 
changes, however, do not require that states assess any financial 
penalties on MCOs, PIHPs, and PAHPs that do not meet a minimum MLR. We 
encourage states to adopt minimum MLRs (of at least 85 percent) or to 
develop similar financial arrangements to incentivize better plan 
performance; however, as states are already permitted to implement a 
minimum MLR or similar standards and some choose not to do so, we 
believe that this rule is unlikely to encourage more states to do so 
and therefore is unlikely to have any direct financial impact on 
Medicaid expenditures for MCOs, PIHPs, and PAHPs. Despite this, we 
believe that there is the potential for some financial impact when 
considering the MLR requirements and the actuarial soundness standards 
requirements.
    We do not collect data or information on the MLRs of Medicaid MCOs, 
PIHPs, and PAHPs, nor do we collect the data or information necessary 
to calculate the

[[Page 27838]]

loss ratios. Milliman has published a series of annual research papers 
that review Medicaid MCO performance, including data on MLRs. We have 
reviewed the most recent research papers covering 2011, 2012, and 2013 
for the potential impact of the final regulation on managed care plans' 
MLRs (``Medicaid Risk-Based Managed Care: Analysis of Financial Results 
for 2011,'' Palmer and Pettit, July 2012; ``Medicaid Risk-Based Managed 
Care: Analysis of Financial Results for 2012,'' Palmer and Pettit, June 
2013; ``Medicaid Risk-Based Managed Care: Analysis of Financial Results 
for 2013,'' Palmer and Pettit, June 2014; and ``Medicaid Risk-Based 
Managed Care: Analysis of Financial Results for 2014,'' Pettit and 
Palmer, June 2015). These studies provide an analysis of Medicaid 
managed care plans, including loss ratios, covering 35 states and 
territories, including the District of Columbia and Puerto Rico, and up 
to 182 managed care plans.
    From 2011 to 2014, the mean MLR varied between 85.5 percent and 
87.9 percent, with an average of 86.7 percent over the 4-year period 
(weighted by the number of plans reporting each year). A significant 
percentage of plans experienced loss ratios below the 85-percent target 
noted in this final rule. In each year, 10 percent of plans experienced 
loss ratios below 77.4 percent to 79.4 percent, and 25 percent of plans 
experienced loss ratios below 81.8 percent to 83.6 percent. Thus, we 
would expect a substantial number of plans would likely not meet a 
minimum loss ratio of 85 percent each year.
    We fit a normal distribution to the MLRs based on the average loss 
ratios at each percentile shown in the Milliman reports (10th, 25th, 
50th, 75th, and 90th) for 2011, 2012, 2013, and 2014. This suggested 
that between 37 percent and 39 percent of plans would have loss ratios 
equal to or less than 85 percent over this period. Assuming that the 
distribution of loss ratios is not affected by the size of the MCO or 
the MCO's total revenue (in general, the Milliman reports did not 
suggest any apparent correlation), we calculate that if all states 
enforced a minimum MLR of 85 percent and if MCOs with smaller loss 
ratios had to return revenue such that the effective loss ratio would 
be equal to 85 percent, then managed care plans would, on average, 
return 1.5 percent to 1.9 percent of total revenue. To the extent that 
smaller MCOs, PIHPs, and PAHPs would receive a credibility adjustment, 
which would effectively lower the minimum MLR standard for those plans; 
we estimated that the impact of the credibility adjustment would be 
less than 0.1 percent, and have not made adjustments to the estimates 
to account for the relatively smaller impact of the credibility 
adjustment.
    In 2013, the sum of MCO, PIHP, and PAHP payments was $132 billion 
(CMS, Financial Management Report--Base Payments); \18\ therefore, we 
estimate that if a minimum MLR had been enforced for each MCO, PIHP or 
PAHP in all states in 2013, between $2.0 billion and $2.5 billion would 
have been returned by MCOs, PIHPs, and PAHPs to the federal government 
and the states in that year.
---------------------------------------------------------------------------

    \18\ CMS, CMS-64 (Financial Management Report)--Base Payments, 
2013. https://www.medicaid.gov/medicaid-chip-program-information/by-topics/financing-and-reimbursement/expenditure-reports-mbes-cbes.html.
---------------------------------------------------------------------------

    As of 2013, we found, based on an internal review, that of the 12 
states that had minimum MLR requirements, 6 states did not enforce any 
financial penalties, and 2 of the 6 states that did enforce penalties 
had minimum MLRs of less than 85 percent. The 6 states that did enforce 
financial penalties accounted for about 13 percent of Medicaid MCO, 
PIHP, and PAHP expenditures in 2014.
    There is significant variation in the standards currently in place, 
as states may have different methods of calculating MLRs (for example, 
which medical expenses and losses are included, and whether they make 
certain adjustments to plans' revenues) and different minimum MLRs 
(although all such minimums are between 80 percent and 88 percent). In 
addition, many states that implemented the eligibility expansion under 
the Affordable Care Act to all adults up to age 65 with household 
incomes of 138 percent or less included a minimum MLR requirement or a 
similar risk-sharing arrangement in its contracts with MCOs, PIHPs, and 
PAHPs for 2014. These current requirements and standards may have some 
effect on the potential impact of the final changes.
    For the purpose of illustrating the potential impact of these 
changes in the regulation, we have developed estimates assuming that 
all states would require a minimum MLR. If all states implemented the 
85 percent minimum MLR requirement that is required by the final rule, 
we estimate that the federal government would collect about $7 billion 
to $9 billion between 2018 and 2020 and the states would collect about 
$4 billion to $5 billion over the 3-year period. This calculation also 
accounts for states that already have a minimum loss ratio requirement 
in place by excluding any effect on states that currently enforce 
remittances for plans with MLRs below 85 percent and including only a 
partial impact from states that currently enforce remittances on plans 
with MLRs at lower minimum MLR. These estimated amounts would account 
for about 1.3 percent to 1.7 percent of projected MCO, PIHP, and PAHP 
expenditures.
    We assume that this rule would not lead more states to implement an 
enforceable, minimum MLR; we therefore conclude that there would be no 
direct significant financial impact of the MLR provisions of the final 
rule on MCOs, PIHPs, and PAHPs. For the 2 states that currently enforce 
penalties at a lower minimum MLR, the estimated effect would be less 
than 0.1 percent of total MCO, PIHP, and PAHP payments if they 
increased the minimum MLR to 85 percent. (It is also possible those 
states may choose to eliminate any MLR penalty, in which case total 
payments may slightly increase instead.)
    Considering the final MLR requirements and changes to the 
requirements for actuarial soundness in Sec.  438.4(b)(9) that require 
rates to be developed in such a way that the MCO, PIHP, or PAHP would 
reasonably achieve an MLR of at least 85 percent for the rate year, we 
believe it is possible that collecting and reporting MLRs for each MCO, 
PIHP, or PAHP and additional oversight of the rate setting process may 
lead states in the future to make adjustments to how they set 
capitation rates. For example, if this additional information led a 
state to realize that the loss ratios for the MCOs, PIHPs, or PAHPs 
were consistently higher or lower than expected, the state may adjust 
future rates lower or higher. We believe that there may be cases that 
lead to rate increases and other cases that lead to rate decreases 
relative to what the rates otherwise would have been.
    As the states have the discretion to determine whether or not to 
require a remittance if plans do not meet the minimum MLR, it is 
possible that actual savings due to the MLR provisions of the 
regulation would be less than the estimated savings if remittances were 
required from all plans. Requiring reporting of the MLR and the actuary 
to consider those results in developing rates is expected to have some 
impact, which are described in the following section of this analysis.
    Using a similar methodology as described previously to estimate the 
potential impact if all states were to require a minimum MLR of 85 
percent, we have estimated what the effects of reporting the MLR and 
the other actuarial soundness requirements would

[[Page 27839]]

be on Medicaid payments for MCOs, PIHPs, and PAHPs. Instead of 
calculating the amount of payments that would be returned if a minimum 
MLR of 85 percent was required, we have measured the amount of payments 
that would be returned for plans with MLRs below 82 percent (allowing 
for a 3 percent random variation from the 85 percent MLR target), and 
assumed that the indirect effects of these changes would be equal to 50 
percent of that amount. We have assumed for plans with MLRs somewhat 
below 85 percent (which we defined here to be between 82 and 85 
percent) that the states may not need to make significant adjustments 
to rate setting. For plans with MLRs further below 85 percent (82 
percent or less), we assumed that these changes would likely lead to 
decreases in future rates and payments below what would have otherwise 
occurred; however, we also assumed that the rates and payments would 
still have been adjusted by the states, as they would have a financial 
incentive to control managed care plan costs. The percentage of all 
MCO, PIHP, and PAHP payments that would be paid from the plans to the 
federal government and the states for plans under these assumptions is 
estimated to be between 0.35 and 0.6 percent; or about $6 billion to 
$11 billion of 2014 Medicaid managed care plan payments.
    Similarly, we calculated the amount of additional payments that 
would need to be made for plans with high MLRs, which we assumed to be 
95 percent or greater. In these cases, we believe that the plans may 
have a higher likelihood of experiencing a loss. A report on Medicaid 
managed care administrative costs found that 10 percent of plans had 
administrative cost ratios (net of taxes) of 6.1 percent or less 
(``Medicaid Risk-Based Managed Care: Analysis of Administrative Costs 
for 2014,'' Palmer, Pettit, and McCulla, June 2015.) Thus, for the vast 
majority of plans, an MLR of 95 percent or more would likely imply a 
loss in that year for the managed care plan. The Milliman reports found 
that between 2011 and 2014, 25 percent of all managed care plans had 
MLRs above 90.0 to 91.9 percent and 10 percent of plans had MLRs above 
96.4 to 97.3 percent. We believe that in these cases, the states may 
adjust future capitation rates and payments to be higher than they 
otherwise would have been and further assumed that these adjustments 
would equal 50 percent of the difference between a MLR of 95 percent 
and the actual MLR. We estimated that the percentage of all MCO, PIHP, 
and PAHP payments would be increased by between 0.1 and 0.2 percent due 
to these changes or about $2 billion to $4 billion of 2014 Medicaid 
managed care plan payments.
    The net effect of these changes is estimated to be a decrease in 
MCO, PIHP, and PAHP payments of about 0.2 to 0.3 percent. Between 2018 
and 2020, a 0.3 percent decrease in MCO, PIHP, and PAHP expenditures is 
projected to be a reduction of $1.3 billion in federal expenditures and 
of $0.7 billion in state expenditures. We believe that this is a 
reasonable lower bound of the effect of the final changes. We believe 
that a reasonable upper bound of these estimates would be $0, assuming 
that the changes resulted in no financial impact. These estimates are 
shown in Table 9.
[GRAPHIC] [TIFF OMITTED] TR06MY16.029

    There is a significant amount of uncertainty in these estimates 
beyond whether or not states would elect to implement an enforceable 
minimum MLR requirement. States and managed care plans may also adjust 
their behavior as a result of the minimum MLR requirements; for 
example, states may set capitation payment rates differently to target 
certain loss ratios, and managed care plans may make changes to the way 
they manage health care costs and utilization for their enrollees. 
These changes may lead to differences in future expenditures for MCO, 
PIHP, and PAHP expenditures, and thus, the actual experience may differ 
from our estimates.
    In addition, it is not clear that the reports we relied on measure 
the MLR the same way as is finalized in the regulation. To the extent 
that there are differences, the actual range and distribution of MLRs 
among MCOs, PIHPs, and PAHPs that would be measured under the final 
rule may be different than as shown in the studies (for example, if 
there are expenditures that would be considered medical losses under 
the final regulation but were not considered medical losses in the 
Milliman studies). This could lead to the actual effects of the MLR and

[[Page 27840]]

actuarial soundness requirements being different than estimated here. 
In addition, it is possible that the effects of the final actuarial 
soundness and certification requirements may capture some of the same 
effects as estimated here; however, we have not made any adjustments to 
reflect any potential interaction between the two sets of changes.
    Moreover, the extent and effectiveness of CMS' and states' efforts 
to adjust future capitation rates to target certain MLRs are difficult 
to predict. How CMS and the states respond to these changes would 
likely have a large bearing on the effect that these sections of the 
regulation have on future Medicaid expenditures. Finally, these 
projections rely on the data, assumptions, and methodology used to 
develop the President's FY 2017 Budget projections for Medicaid. 
Changes in enrollment, health care costs, and the use of managed care 
plans within Medicaid may differ from these projections and may lead to 
greater or lesser Medicaid MCO, PIHP, and PAHP expenditures.
6. Appeals and Grievances
    Final changes to the appeals and grievances provisions in 
Sec. Sec.  438.400 through 438.416 and Sec.  457.1260 focus on creating 
state and health plan processes that are consistent across product 
lines (that is, MA, Medicaid, CHIP, and QHPs). Medicaid currently 
differs from MA organizations and QHPs in several key ways and these 
differences hinder a streamlined grievance and appeals process across 
the public and private managed care sectors, and creates unnecessary 
administrative complexity for health issuers participating across 
product lines. Our finalized revisions will allow enrollees to better 
understand the grievance and appeals processes and receive a resolution 
of their grievances and appeals more quickly. We believe this will be a 
tremendous benefit to families that have some family members eligible 
for Medicaid and other family members eligible for marketplace 
coverage; enrollees that change between Medicaid and the QHPs due to 
life changes that affect eligibility; and enrollees that are dually 
eligible for Medicaid and Medicare. We believe consistency and quicker 
resolution of issues will not only make the enrollee more comfortable 
using the grievance and appeal systems, but also more confident that 
there is benefit in utilizing them when needed. Health issuers have 
indicated that alignment of these provisions would reduce operational 
burden for those that operate across product lines and in different 
states as it would enable them to create and implement one set of 
uniform processes and procedures. A significant portion of the burden 
associated with this principle is the result of the final rule that 
Medicaid non-NEMT PAHPs comply with the same standards as MCOs and 
PIHPs. This will require non-NEMT PAHPs to develop compliant grievance 
and appeals systems, which will generate some one-time burdens, but we 
believe it is important for enrollees to have an avenue within these 
entities to raise and receive resolution to their grievances and 
appeals. The total estimated first-year COI costs for requiring 
Medicaid non-NEMT PAHPs to meet the same standards as MCOs and PIHPs 
and provide due process to beneficiaries through provisions in part 438 
is a cumulative $1.9 million (detailed burden estimates can be found in 
the COI section of this final rule at sections IV.C.30 through IV.C.35 
for appeals and grievances). We finalized most of the Medicaid 
grievance regulations to CHIP MCOs, PIHPs, and PAHPs. The total 
estimated first-year COI costs associated with implementing the 
grievance provisions of part 457 under this principle is a cumulative 
$9.6 million.
7. Allowing Payment for Institution of Mental Disease for Inpatient 
Psychiatric Services as an In Lieu of Service
    To develop estimates of the impact of the change in policy 
regarding institutions of mental disease (IMDs), OACT reviewed 2010 
data from the Medicaid Analytic eXtract (MAX). Fee-for-service and 
managed care encounter data were reviewed where the place of service 
was an inpatient psychiatric facility, which is expected to reflect IMD 
claims and encounters. Data was reviewed by state and by age of the 
enrollee.
    Using the FFS data for persons ages 22-64,\19\ OACT calculated the 
average inpatient psychiatric facility cost per enrollee, the average 
cost per claim, and the average cost per unit for each state. These 
three averages were then multiplied by the number of enrollees in 
managed care with an inpatient psychiatric facility encounter, the 
number of encounters in managed care, and the number of units in 
managed care, respectively, to impute the costs of these services in 
managed care.
---------------------------------------------------------------------------

    \19\ Data was used for individuals aged 22-64 to remove 
utilization for individuals that were age 20 when services began, 
and therefore, would not be subject to the statutory prohibition of 
FFP for patients in an IMD aged 21-64.
---------------------------------------------------------------------------

    OACT compared the number of enrollees ages 22-64 with an inpatient 
psychiatric facility encounter to the total number of enrollees ages 
22-64. States in which 0.1 percent or more of the Medicaid enrollees 
had an inpatient psychiatric facility encounter in managed care were 
considered likely to be using IMDs as an in lieu of service provider; 
there were 17 states that met this criteria in 2010. (There were 
another 9 states that reported a smaller percentage of enrollees with 
these encounters that could potentially be using IMDs as an in lieu of 
service provider.) This accounted for an estimated $6.0 million in 
expenditures in 2010.
    For these 17 states, the ratio of estimated managed care costs for 
inpatient psychiatric facility services to total expenditures for 
enrollees ages 22-64 was calculated for each state and an overall 
average. The average ratio was 0.009 percent (with the highest ratio 
among these 17 states being 0.029 percent). This represents the average 
percentage of Medicaid expenditures for enrollees that are for 
inpatient psychiatric facility services through managed care. OACT 
assumed that this represents the extent to which IMD services are used 
in managed care in states that do use IMDs as an in lieu of service 
provider.
    To calculate the impact of the policy, OACT multiplied this ratio 
(0.009 percent) by the total amount of expenditures for adult enrollees 
and enrollees with disabilities (which includes adults ages 22-64). 
This total represented the amount of expenditures if all states used 
this option to the same extent that states currently using it have 
done. In 2010, this would have increased expenditures for inpatient 
psychiatric facility services for adults ages 22-64 through managed 
care from $6.0 million to $17.9 million, or an increase of $11.9 
million.
    These amounts were then projected forward using historical data 
from 2010 through 2014 and the projections of enrollment and 
expenditures in the President's FY 2017 Budget, with the assumption 
that this change would be effective for contracts starting July 1, 2017 
or later.

[[Page 27841]]

[GRAPHIC] [TIFF OMITTED] TR06MY16.030

    This estimate is subject to significant uncertainty, and more so 
than other estimates given the limitations with the data. While we 
believe that this represents a reasonable estimate of potential 
impacts, given the lack of clarity about how states allow IMD services 
to be used as in lieu of services currently makes it more difficult to 
assess the impact of this section of the regulation. As these are 
services not allowed for adults under Medicaid, it is not clear how 
accurate the data is (under FFS or managed care), which contributes to 
the uncertainty regarding these estimates. Some of the expenditures in 
the data may be for non-IMD providers; similarly, expenditures for IMDs 
could be reported elsewhere in the data (for example, as other types of 
facilities). In addition, it is not clear how many current IMD stays 
exceed 15 days; we have assumed that none of the IMD stays in the data 
exceed 15 days. More or fewer states may be using IMDs as an in lieu of 
service provider than in 2010, or states may be using this to a greater 
or lesser extent than in 2010. This estimate assumes that states do not 
use IMDs more widely than in the past; however, it is possible that 
they may use IMDs more widely than we are aware of. This estimate also 
does not account for reductions in other expenditures (either directly, 
with IMD services replacing inpatient hospital services, or indirectly, 
with the use of IMD services potentially preventing other utilization 
in the future).
8. Beneficiary Protections
    This guiding principle seeks to protect beneficiaries from harm and 
encompasses regulatory provisions related to enrollment and 
disenrollment; beneficiary support system; continuation of benefits 
pending appeal; authorization of services; continued services and 
coordination of care; managed LTSS; and stakeholder engagement. As the 
use of managed care to deliver Medicaid benefits has grown, so has the 
inclusion of more vulnerable populations into managed care. These new 
populations include persons with disabilities, individuals with 
behavioral health needs, and beneficiaries needing LTSS. The unique 
needs and vulnerability of these newer populations heightens the need 
for added beneficiary protections and thus, contributed to the final 
revisions to the regulations. These protections are expected to benefit 
all Medicaid beneficiaries.
    As shown in Table 11, the COI costs associated with the provisions 
under this principle account for a cumulative $50.4 million in the 
first year for the revisions to part 438 (detailed burden estimates can 
be found in the COI section of this final rule at sections IV.C.8 and 
IV.C.15 for coordination/continuity of care and IV.C.16 for 
authorization of services).

[[Page 27842]]

[GRAPHIC] [TIFF OMITTED] TR06MY16.031

    Similarly, as shown in Table 12, the COI costs associated with 
implementing the provisions under this principle account for a 
cumulative $7 million in the first year for the revisions to part 457.

[[Page 27843]]

[GRAPHIC] [TIFF OMITTED] TR06MY16.032

9. Coordination and Continuity of Care
    The provisions for coordination and continuity of care are in Sec.  
438.62 and Sec.  438.208. Under current regulations, these sections 
focus only on primary and acute medical care, which may not be 
appropriate or consistent with the needs of people with disabilities, 
frail elders, and other LTSS populations. These populations rely 
heavily on less traditional services, such as support services for 
work, community activity access, and assistance with activities of 
daily living. For example, people with dementia may prefer and be able 
to live in the community with personal care assistance, memory aids, 
and alerting systems, but may not be able to identify and notify a care 
coordinator in situations of neglect or abuse. A young adult with an 
intellectual disability may be able to work with supports in place, but 
be at risk of harm if transportation falls through or a support worker 
does not show up for a scheduled time. These populations often require 
heightened levels of monitoring and oversight by the care coordinator 
to ensure that they are able to fully access the services and supports 
needed to thrive in the community and to be sure that risks of harm or 
abuse are mitigated. Additionally, some providers of LTSS are 
unaccustomed to working with managed care plans and care coordinators 
can be the bridge to establishing and building a productive

[[Page 27844]]

relationship with these providers to best meet enrollees' needs.
    The final regulations address these enhanced care coordination 
needs by finalizing provisions to strengthen the role of care 
coordinators who help beneficiaries transition from providers and 
services available through their current delivery system to providers 
and services available through a managed care plan. Care coordinators 
can help enrollees with finding specialty providers, understanding how 
the managed care program works, setting appointments, verifying 
delivery of services, and reminding enrollees of their appointments. 
The final regulations have been strengthened to ensure that individuals 
with LTSS needs complete an accurate and timely person-centered 
assessment and service planning process with more frequent monitoring 
to assist beneficiaries in fully utilizing services. The changes to 
these provisions are designed to enable people with disabilities and 
LTSS enrollees to live, work, and participate in the setting of their 
choice more safely, effectively, and with fewer lapses in care. 
Additionally, we enhanced existing requirements for coordination and 
continuity of care when enrollees move between managed care plans or 
programs. While this has always been a requirement in part 438, we are 
aware of gaps in some states' and managed care plans' implementation 
for the LTSS population.
    Behavioral health, substance use disorders, and institutional 
services are the most common services that managed care enrollees 
receive through FFS; coordinating these services with the managed care 
services is crucial to comprehensive care management. Enrollees 
receiving behavioral health or substance use treatment on a frequent, 
sometimes daily, basis are at high risk for emergency department visits 
or setbacks to their recovery if they experience a disruption in their 
services. The added protections provided by the finalized changes will 
ensure that enrollees, particularly those with complex health needs, 
experience smoother transitions, have fewer incidents of abuse or 
neglect, are able to retain the ability to live in their communities, 
and have fewer emergency department visits or admissions. For enrollees 
receiving on-going care and LTSS, lapses in care can trigger acute 
events and even be life threatening. Putting additional protections in 
place to prevent such occurrences is critical to enrollees' health 
outcomes. Care coordinators can help enrollees in these situations with 
finding appropriate providers, understanding how the managed care 
program works, setting appointments, and ensuring that appropriate 
authorizations are in the system to facilitate claims payment.
    While we believe that the benefits of care coordination have a 
significant positive impact on the quality of life, consumer 
experience, and health outcomes for enrollees, we acknowledge that the 
activities that would bring about these positive impacts will likely 
generate costs. From an administrative perspective, the provisions in 
Sec. Sec.  438.62 and 438.208 have an estimated first-year COI cost of 
$49.8 million (detailed burden estimates can be found in the COI 
section of this final rule at sections IV.C.8 and IV.C.15, 
respectively). In general, we expect that most of the activities that 
would be required under the regulation are already being provided in 
some form by the state Medicaid program or by their MCOs, PIHPs, and 
PAHPs. We anticipate little to no new impacts in practice or in 
expenditures on activities already occurring with existing populations 
and benefits. However, we believe there is a greater likelihood that 
the finalized changes in the regulation specific to MLTSS could lead to 
new or additional care coordination expenditures. There are currently 
20 states that use MLTSS. Unfortunately, there is very limited data 
available to determine the potential impact of this section of the 
final regulation. We do not collect consistent or validated cost data 
on Medicaid managed care encounters or administrative costs and, 
therefore, it is not possible to determine the amount of new 
expenditures for MCOs, PIHPs, and PAHPs to provide particular services 
or to serve particular enrollees. In any managed care program, we would 
generally expect care coordination expenditures to be a notable portion 
of MCO, PIHP, and PAHP administrative costs. Milliman has published 
studies \20\ on the financial performance of Medicaid managed care 
plans that contains data on administrative costs for plans. These 
studies provide an analysis of Medicaid managed care plans covering 35 
states and territories, including the District of Columbia and Puerto 
Rico, and up to 167 managed care plans. According to these studies, the 
average ratio of administrative expenditures to plan revenues ranged 
from 11.4 percent to 12.3 percent between 2011 and 2014, or about $20.0 
billion to $21.6 billion of 2014 Medicaid managed care plan payments. 
We believe that care coordination costs would likely be some fraction 
of that percentage, but are not able to determine the specific 
proportion. Given that administrative costs may cover a range of 
activities including adjudicating and paying claims, developing and 
maintaining provider networks, assisting consumers, and other general 
business operations, we believe that it is most likely that care 
coordination costs are between 1 and 3 percent of plan revenue.
---------------------------------------------------------------------------

    \20\ ``Medicaid Risk-Based Managed Care: Analysis of Financial 
Results for 2011,'' Palmer and Pettit, July 2012; ``Medicaid Risk-
Based Managed Care: Analysis of Financial Results for 2012,'' Palmer 
and Pettit, June 2013; ``Medicaid Risk-Based Managed Care: Analysis 
of Financial Results for 2013,'' Palmer and Pettit, June 2014; and 
``Medicaid Risk-Based Managed Care: Analysis of Financial Results 
for 2014,'' Palmer, Pettit, and McCulla.
---------------------------------------------------------------------------

    Unfortunately, there is also little data or research available on 
the amount of care coordination expenditures provided by MCOs, PIHPs, 
or PAHPs and the effectiveness of care coordination. Some studies have 
found that care coordination may lead to reductions in preventable 
inpatient readmissions and costs related to screening, testing, and 
evaluation. Studies \21\ of transitional care models have found that 
they may reduce hospital readmissions while other demonstrations have 
found that care coordination has had some success in reducing 
hospitalizations and specialist visits).\22\ There are other studies 
\23\ that have shown that care coordination may not have a significant 
effect on health care expenditures; for example, a study of one 
Medicare demonstration \24\ showed that most care coordination programs 
did not have a significant effect on the costs or the quality of care, 
and even successful programs were not able to achieve savings large 
enough to offset care coordination costs.
---------------------------------------------------------------------------

    \21\ (''Estimated Federal Savings Associated with Care 
Coordination Models for Medicare-Medicaid Dual Eligibles,'' Thorpe 
2011.
    \22\ (``Effects of Primary Care Coordination on Public Hospital 
Patients,'' Schillinger, Bibbins-Domingo, Vranizan, Bacchetti, Luce, 
and Bindman, Journal of General Internal Medicine, December 2001.
    \23\ (``Effects of Care Coordination on Hospitalization, Quality 
of Care, and Health Care Expenditures Among Medicare 
Beneficiaries,'' Peikes, Chen, Schore, and Brown, The Journal of the 
American Medical Association, February 2009; ``Six Features of 
Medicare Coordinated Care Demonstration Programs That Cut Hospital 
Readmissions of High-Risk Patients,'' Brown, Peikes, Peterson, 
Schore, and Razafindrakoto, Health Affairs, June 2012.
    \24\ (``Effects of Care Coordination on Hospitalization, Quality 
of Care, and Health Care Expenditures Among Medicare 
Beneficiaries,'' Peikes, Chen, Schore, and Brown, The Journal of the 
American Medical Association, February 2009.
---------------------------------------------------------------------------

    It should be noted that these studies, and most other studies 
available, have examined the effects of care coordination on 
hospitalizations and

[[Page 27845]]

utilization of physician services on general Medicaid and/or Medicare 
populations; we are not aware of any studies or research that focuses 
specifically on the impact of care coordination on beneficiaries who 
are using LTSS. Many Medicaid enrollees receiving LTSS are also 
enrolled in Medicare, and for those enrollees Medicare is typically the 
primary payer for hospital and physician services. Thus, to the extent 
care coordination for Medicaid enrollees receiving long-term care 
services is effective, it is possible that there may be financial 
impacts to Medicare (and in some cases these impacts may be greater for 
Medicare than Medicaid).
    While we do not collect the amount of managed care capitation 
payments or expenditures in such a way that the amount paid for managed 
long-term care services can be determined, we estimate about 38 percent 
of total Medicaid managed care expenditures were provided for aged and 
disabled enrollees in 2013 ($50 billion of $132 billion), and we expect 
a significant amount of those expenditures covered acute care services. 
Thus, the potential amount of expenditures on LTSS under Medicaid 
managed care programs is expected to be relatively small compared to 
the rest of the program. We believe that enrollees will benefit from 
increased care coordination activity; however, at this time, we believe 
a reasonable estimate of the financial impact of the changes to care 
coordination requirements under the regulation is that there would be a 
net impact of $0. We believe that the expected increase in care 
coordination costs is likely to be small and that the effect of those 
activities on overall health benefit expenditures would be limited. The 
effect on overall expenditures would vary significantly depending on 
how successfully the managed care plans implement and/or enhance their 
current coordination efforts. We expect that provisions finalized in 
this rule related to setting actuarially sound rates, performance 
reporting, and encounter data reporting would enable more robust 
analysis of the effects of care coordination and transition efforts on 
expenditures in the future.
    We finalized some of the Medicaid beneficiary protections to CHIP, 
specifically the requirements in Sec.  438.62, Sec.  438.208, and Sec.  
438.210. We believe these protections will ensure that enrollees, 
particularly those with complex health needs, experience smoother 
transitions, and have fewer emergency department visits or admissions. 
The final provisions in Sec. Sec.  438.62, 438.208, and 438.210 
associated with implementing the beneficiary protection provisions of 
part 457 have an estimated first-year COI cost of a cumulative $7 
million.
10. Modernizing Regulatory Requirements
    This guiding principle seeks to incorporate the numerous 
advancements in state activities, managed care plan practices, and 
federal oversight interests since part 438 was finalized in 2002, with 
the exception of subpart E which was finalized in 2003. This guiding 
principle covers the regulatory topics of network adequacy and 
accessibility of services; quality measurement and improvement; state 
monitoring standards; information standards; primary care case 
management; choice of managed care plans; non-emergency transportation; 
and state plan standards. As shown in Table 13, the COI costs 
associated with the provisions under this principle account for a 
cumulative $31.4 million in the first year for the revisions to part 
438 (detailed burden estimates can be found in the COI section of this 
final rule at section V.C.5 for information standards and sections 
IV.C.19 through IV.C.29 for quality framework).

[[Page 27846]]

[GRAPHIC] [TIFF OMITTED] TR06MY16.033

    Similarly, as shown in Table 14, the COI costs associated with 
implementing the provisions under this principle account for a 
cumulative $4.6 million in the first year for the revisions to part 
457.

[[Page 27847]]

[GRAPHIC] [TIFF OMITTED] TR06MY16.034

    The provision of information to potential enrollees by the state 
and to enrollees by the managed care plans has always been a 
requirement in Sec.  438.10. However, we have finalized changes to this 
section to better organize and clarify the standards for states and 
managed care plans. These changes are necessary, and important, since 
the information provided to potential and current enrollees is critical 
in aiding them to make informed decisions when selecting a managed care 
plan and to sufficiently understand the managed care program to 
maximize the benefits and rights available to them. For example, 
without information presented in an easily understood way, an enrollee 
may choose a managed care plan that does not have their existing 
providers in the network, which may force the enrollee to change their 
providers. This is particularly challenging for enrollees with 
disabilities or receiving LTSS, because these individuals often receive 
services that assist with activities of daily living in their home. 
Disruption in services from their usual providers can cause numerous 
problems and may prevent them from living safely and effectively in 
their chosen setting.
    We finalized changes to the content and delivery methods for 
notices, handbooks, formularies, and provider directories to facilitate 
the dissemination of timely and complete information that potential 
enrollees and enrollees need. Current Sec.  438.10 pertaining to 
information requirements do not reflect current technology advances 
that enable states and managed care plans to provide access to 
information more quickly, accurately, and less expensively. As more

[[Page 27848]]

consumers understand and rely on electronic information, not revising 
this section and continuing to mandate that all information be provided 
by mailing paper would be unrealistic, unnecessarily costly, and not in 
the beneficiaries' or managed care plans' best interest. Many states 
and managed care plans have been providing required information in both 
electronic and paper form for several years; the final rule will 
eliminate this duplication. Since the transition to electronic 
communication will be gradual and at varying rates, we expect the 
burden for providing the information required in Sec.  438.10 to 
diminish over time. The provisions in Sec.  438.10 have an estimated 
first-year COI cost of a cumulative $0.6 million (detailed burden 
estimates can be found in the COI section of this final rule at section 
V.C.5 for information standards). As required by section 2103(f)(3) of 
the Act, added by section 403 of CHIPRA, and consistent with the 
requirements of section 2101(a) to provide coverage in an effective and 
efficient manner, we also propose to apply the standards of Sec.  
438.10 to CHIP in Sec.  457.1207. The total estimated first-year COI 
costs associated with implementing the information requirements in part 
457 is a cumulative $0.3 million.
11. Quality Measurement and Improvement
    There are several items that drive the new burden associated with 
the finalized quality provisions. Given that some PAHPs may provide 
clinical services, such as dental or behavioral health services, we 
will apply the quality standards in part 438 subpart E to PAHPs. This 
will ensure that they are subject to the same approach to measuring and 
improving quality as are MCOs and PIHPs, which will allow for better 
oversight and accountability. We will also apply select provisions of 
part 438 subpart E (specifically, Sec.  438.330(b)(2), (b)(3), (c), and 
(e), Sec.  438.340, and Sec.  438.350) to PCCM entities whose contracts 
with the state provide for shared savings, incentive payments or other 
financial reward for the PCCM entity for improved quality outcomes. 
This will ensure appropriate oversight of PCCM entities whose 
compensation is tied to quality improvement. The QAPI program 
provisions at Sec.  438.330 reflect the expansion of managed care to 
LTSS. By specifically addressing LTSS within their QAPI program, MCOs, 
PIHPs, and PAHPs will have tools that can be used to provide 
accountability for the care provided to this vulnerable population. The 
new mandatory EQR-related activity (validation of network adequacy) and 
the state review of the accreditation status of MCOs, PIHPs, and PAHPs 
will also support state oversight of managed care plans, and help to 
ensure that consumers have access to high-quality plans. Similarly, 
state-based MMC QRSs for MCOs, PIHPs, and PAHPs will assist consumers 
in identifying the plan that best meets their needs. States contracting 
with MCOs or PIHPs currently maintain a written strategy for assessing 
and improving the quality of managed care services offered by all MCOs 
and PIHPs. Under the final rule, we have expanded the requirement in 
Sec.  438.340 for a quality strategy to states contracting with PAHPs 
and PCCM entities described in Sec.  438.310(c)(2). The total estimated 
first-year COI costs associated with the finalized modifications to the 
managed care quality components of the regulations is a cumulative 
$30.6 million (detailed burden estimates can be found in the COI 
section of this final rule at section V.C.19 through V.C.29 for quality 
framework).
    As required by section 2101(f)(3) of the Act, added by section 403 
of CHIPRA, and consistent with the requirements of section 2101(a) of 
the Act to provide coverage in an effective and efficient manner, we 
also propose to apply the quality standards of 438 subpart E and 431 
subpart I to CHIP in Sec. Sec.  457.760, 457.1240, and 457.1250. The 
total estimated first-year COI costs associated with implementing the 
quality standards in part 457 is a cumulative $4.2 million.
    The final regulation makes a number of changes related to Medicaid 
quality of care, primarily for Medicaid managed care programs, 
including requirements for state managed care quality strategies, QAPI 
programs, MMC QRSs, state review of the accreditation status of 
contracted Medicaid managed care plans, and EQRs. While these changes 
are expected to lead to improvements in the quality of care delivered 
by states and Medicaid managed care plans, it is difficult to determine 
whether or not these changes would have any financial impacts on 
Medicaid expenditures. We would expect some activities would be 
unlikely to have a financial impact (such as the posting online of the 
accreditation status of Medicaid managed care plans per Sec.  438.332), 
while other activities may lead to some small increases or decreases in 
expenditures. For example, some activities may require managed care 
plans to increase expenditures to improve the quality of care and meet 
certain quality standards associated with some of the changes in the 
regulation, while other activities may improve the quality of care and 
lead to a net decrease in benefit expenditures. We believe that it is 
not possible to estimate the potential financial impacts of these 
changes and believe that any impacts on net Medicaid expenditures would 
be negligible. While we invited comment on possible ways to quantify 
the costs and/or benefits associated with these proposed provisions, no 
comments were received on this topic.
12. Network Adequacy
    We finalized Sec.  438.68 to establish minimum standards in the 
area of network adequacy. This section aims to maintain state 
flexibility while modernizing the current regulatory framework to 
reflect the maturity and prevalence of Medicaid managed care delivery 
systems, promote processes for ensuring access to care, and align, 
where feasible, with other private and public health care coverage 
programs. Therefore, we finalized standards to ensure ongoing state 
assessment and certification of MCO, PIHP, and PAHP networks, set 
threshold standards for the establishment of network adequacy measures 
for a specified set of providers, establish criteria for developing 
network adequacy standards for MLTSS programs, and ensure the 
transparency of network adequacy standards. As many states currently 
have some network standards in place, we estimate only a small 
administrative burden to states to implement these provisions.
    In general, we would expect strengthening network adequacy 
standards could increase expenditures, as some plans may need to add 
more providers to in their networks and, in doing so, may need to 
increase provider reimbursement rates. In addition, adding more 
providers to plan networks could potentially lead to more use of health 
care services among the providers added, whether primary care 
physicians, specialists, or other providers. However, the changes in 
the regulation are limited and only include requirements about setting 
and reporting network adequacy standards. The final regulation does not 
establish network adequacy standards. Thus, while a state may need to 
adapt its network adequacy standards to include criteria specified in 
the regulation or to provide additional reports and information about 
those standards, we do not assume that these changes would necessitate 
significant changes to the standards currently in place in states.

[[Page 27849]]

13. Implementing Statutory Provisions
    This guiding principle seeks to implement the statutory provisions 
impacting Medicaid and CHIP managed care that have passed since the 
Balanced Budget Act of 1997 (BBA). This principle covers the regulatory 
topics of incorporating provisions for encounter data and health 
information systems requirements established in the Affordable Care Act 
and requirements for contracts involving Indians established in the 
American Recovery and Reinvestment Act (ARRA). The total estimated 
first-year COI costs associated to the provisions under this principle 
account for a cumulative $0.1 million (provisions in Sec. Sec.  438.14, 
438.242, and 438.818) (detailed COI burden estimates can be found in 
the COI section of this final rule at sections IV.C.18 and IV.C.39 for 
encounter data and health information systems and IV.C.6 for contracts 
involving Indians). No additional quantifiable benefits or costs were 
identified for these provisions.
14. Other Provisions
    Changes in Subpart F of part 438 that include references to part 
431 require minor changes to Sec.  431.220 and Sec.  431.244. Without 
these changes, the sections would be inconsistent with the changes in 
part 438. There is no burden associated with this change as it is a 
technical correction and any related burden is included in Sec.  
438.408(f).
    In Sec.  433.138, technical corrections remove an obsolete 
reference to ``ICD-9'' and replace it with text that does not alter the 
meaning or need to be updated as newer versions of the International 
Classification of Diseases are published in the future. There is no 
burden associated with this change as states are not mandated to make 
any changes to their policies or procedures as a result of this revised 
text.

C. Anticipated Effects

    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, we estimate that 
some PAHPs, PCCMs, and PCCM entities are likely to be small entities as 
that term is used in the RFA. For purposes of the RFA, we estimate that 
most MCOs and PIHPs are not small entities as that term is used in the 
RFA. For purposes of the RFA and according to the Small Business 
Administration (SBA) and the Table of Small Business Size 
Standards,\25\ small entities include small businesses in the health 
care sector that are direct health and medical insurance issuers with 
average annual receipts of less than $38.5 million and offices of 
physicians or health practitioners with average annual receipts of less 
than $11 million. For purposes of the RFA, individuals and state 
governments are not included in the definition of a small entity.
---------------------------------------------------------------------------

    \25\ Small Business Administration (SBA), https://www.sba.gov/contracting/getting-started-contractor/make-sure-you-meet-sba-size-standards/summary-size-standards-industry-sector.
---------------------------------------------------------------------------

    As of 2012, there are 335 MCOs, 176 PIHPs, 41 PAHPs, 20 NEMT PAHPs, 
25 PCCMs, and 9 PCCM entities participating in the Medicaid managed 
care program. We estimate that there are an additional 62 entities that 
serve only CHIPs, including approximately 55 MCOs and PIHPs, 3 PAHPs, 
and 4 PCCMs. We believe that only a few of these entities qualify as 
small entities. Research on publicly available records for the entities 
allowed us to determine the approximate counts presented. Specifically, 
for the managed care entities participating in Medicaid managed care 
programs, we believe that 10 to 20 PAHPs, 8 to 15 PCCMs, and 2 to 5 
PCCM entities are likely to be small entities. For the managed care 
entities that serve only CHIP, we believe that 2 to 4 PCCMs and PAHPs 
are likely to be small entities. We believe that the remaining MCOs and 
PIHPs have average annual receipts from Medicaid and CHIP contracts and 
other business interests in excess of $38.5 million. In analyzing the 
scope of the impact of these regulations on small entities, we examined 
the United States Census Bureau's Statistics of U.S. Businesses for 
2012. According to the 2012 data, there are 4,506 direct health and 
medical insurance issuers with less than 20 employees and 156,408 
offices of physicians or health practitioners with less than 20 
employees. For purposes of the RFA, we believe that we are impacting 
less than 1 percent of the small entities that we have identified.
    The primary impact on small entities will be through the standards 
placed on PAHPs, PCCMs, and PCCM entities through the following 
requirements: (1) Adding PCCMs and PCCM entities, where appropriate, to 
the information standards in Sec. Sec.  438.10 and 457.1207 regarding 
enrollee handbooks, provider directories, and formularies; (2) adding 
PAHPs, PCCMs, and PCCM entities in Sec.  438.62 to implement their own 
transition of care policies and PAHPs in Sec.  438.208 to perform 
initial assessments and care coordination activities and applying these 
standards to CHIP in Sec. Sec.  457.1216 and 457.1230(c); (3) adding 
PAHPs in Sec.  438.242 to collect data on enrollee and provider 
characteristics and on services furnished to enrollees through an 
encounter data system or other such methods and applying these 
standards to CHIP in Sec.  457.1230(d); (4) adding PCCM entities to the 
QAPI program standards in Sec.  438.330 and applying these standards to 
CHIP in Sec.  457.1240; (5) adding PAHPs in Sec.  438.350 to the list 
of affected entities regarding the EQR process and applying these 
standards to CHIP in Sec.  457.1250; and (6) adding PAHPs to the types 
of entities subject to the standards of subpart F to establish a 
grievances and appeals system and process and applying these standards 
to CHIP in Sec.  457.1260. We do not believe that the remaining impacts 
or burdens of the provisions of this final rule are great on the small 
entities that we have identified.
    For purposes of the RFA, all cost estimates were derived from the 
Collection of Information calculations in section V. of this final 
rule. The estimated costs associated with the impacts on small entities 
listed above are primarily attributable to the transition of care 
policies for PAHPs, PCCMs, and PCCM entities, initial assessments and 
care coordination activities for PAHPs, and the establishment of a 
grievances and appeals system and process for PAHPs. Due to the small 
number of small entities participating in CHIP managed care which we 
believe will be affected, the Secretary has determined that the 
regulations in part 457 of this rulemaking will not have a significant 
economic impact on a substantial number of small entities. With respect 
to Medicaid, the transition of care policies, initial assessments, and 
care coordination activities for PAHPs account for approximately $2.4 
million of the cumulative $4.5 million annual impact on the 41 PAHPs 
(detailed burden estimates can be found in the COI section of this 
final rule at sections IV.C.8 and IV.C.15 for coordination/continuity 
of care). The establishment of a grievances and appeals system and 
process accounts for approximately $1.1 million of the cumulative $4.5 
million annual impact on the 41 PAHPs (detailed burden estimates can be 
found in the COI section of this final rule at sections IV.C.30 through 
IV.C.35 for grievances and appeals). The total estimated annual burden 
per PAHP is less than $0.1 million, or less than 1 percent of the $38.5 
million threshold. The transition of care policies for PCCMs and PCCM 
entities account for approximately $0.4 million of the cumulative $0.6 
million annual impact

[[Page 27850]]

on the 34 PCCMs and PCCM entities (detailed burden estimates can be 
found in the COI section of this final rule at sections IV.C.8 and 
IV.C.15 for coordination/continuity of care). The total estimated 
annual burden per PCCM or PCCM entity is less than $0.1 million, or 
less than 1 percent of the $11 million threshold.
    These small entities must meet certain standards as identified in 
the provisions of this final rule; however, we believe these are 
consistent with the nature of their business in contracting with state 
governments for the provision of services to Medicaid and CHIP managed 
care enrollees. Therefore, based on the estimates in the COI (section V 
of this final rule), we have determined, and the Secretary certifies, 
that this final rule will not have a significant economic impact on a 
substantial number of small entities. In the proposed rule, we invited 
comment on our proposed analysis of the impact on small entities and on 
possible alternatives to provisions of the proposed rule that would 
reduce burden on small entities. We received no comments and are 
finalizing our analysis as proposed in this final rule.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis for any rule that may have a significant 
impact on the operations of a substantial number of small rural 
hospitals. This analysis must conform to the provisions of section 604 
of the RFA. For purposes of section 1102(b) of the Act, we define a 
small rural hospital as a hospital that is located outside a 
Metropolitan Statistical Area and has fewer than 100 beds.
    We do not anticipate that the provisions in this final rule will 
have a substantial economic impact on most hospitals, including small 
rural hospitals. Provisions include some new standards for State 
governments, MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities but no direct 
requirements on individual hospitals. The impact on individual 
hospitals will vary according to each hospital's current and future 
contractual relationships with MCOs, PIHPs, PAHPs, PCCMs, and PCCM 
entities, but any additional burden on small rural hospitals should be 
negligible. In the proposed rule, we invited comment on our proposed 
analysis of the impact on small rural hospitals regarding the 
provisions of the proposed rule. We received no comments.
    We are not preparing analysis for either the RFA or section 1102(b) 
of the Act because we have determined, and the Secretary certifies, 
that this final rule will not have a significant economic impact on a 
substantial number of small entities or a significant impact on the 
operations of a substantial number of small rural hospitals in 
comparison to total revenues of these entities.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2015, that 
is approximately $144 million. This final rule does not contain any 
federal mandate costs resulting from (A) imposing enforceable duties on 
state, local, or tribal governments, or on the private sector, or (B) 
increasing the stringency of conditions in, or decreasing the funding 
of, State, local, or tribal governments under entitlement programs. We 
have determined that this final rule does not impose any mandates on 
state, local, or tribal governments, or the private sector that will 
result in an annual expenditure of $144 million or more.
    We received the following comment on section 202 of the UMRA:
    Comment: One commenter stated that the proposed rule was 
potentially a significant unfunded mandate and recommended that CMS 
withdraw the rule.
    Response: The commenter did not provide any data or evidence to 
further this claim or demonstrate the applicability of UMRA; therefore, 
we retain our position that this final rule does not impose any 
mandates on state, local, or tribal governments, or the private sector 
that will result in an annual expenditure of $144 million or more.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a final rule that imposes substantial 
direct requirement costs on state and local governments, preempts state 
law, or otherwise has Federalism implications. We believe this final 
regulation gives states appropriate flexibility regarding managed care 
standards (for example, setting network adequacy standards, setting 
credentialing standards, EQR activities), while also aligning Medicaid 
and CHIP managed care standards with those for plans in the Marketplace 
and MA to better streamline the beneficiary experience and to reduce 
administrative and operational burdens on states and health plans 
across publicly-funded programs and the private market. We have 
determined that this final rule would not significantly affect states' 
rights, roles, and responsibilities.
1. Effects on Other Providers
    The providers directly affected by the provisions of this rule are 
the MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities under contract to a 
state Medicaid or CHIP agency. As detailed in the sections above, the 
effect of the final rule varies by entity type and amount of burden. 
Setting actuarially sound rates and MLR are the areas with the largest 
impact on the managed care plans. We believe that many of the final 
rate setting provisions are unlikely to have a direct effect on the 
actual capitation rates or future Medicaid expenditures. To the extent 
that these new standards or requirements do have an effect on 
capitation rates or Medicaid expenditures, we believe that generally it 
is likely that this could lead to increases in some cases and decreases 
in other cases in the capitation payment rates and Medicaid 
expenditures. The sum of the estimated financial impacts of these 
changes could increase expenditures as much as $3.7 billion from 2016 
to 2020, and could decrease expenditures as much as $8.7 billion from 
2016 to 2020.
    The regulation finalizes new requirements that would require the 
states to calculate and report the MLRs for Medicaid MCOs, PIHPs, and 
PAHPs in Sec.  438.4 and Sec.  438.5, and to add new Sec.  438.8 and 
Sec.  438.74. These changes, however, do not require that states assess 
any financial penalties on MCOs, PIHPs, and PAHPs that do not meet a 
minimum MLR. The net effect of these changes is estimated to range from 
zero impact to a decrease in MCO, PIHP, and PAHP payments of about 0.2 
to 0.3 percent. Between 2018 and 2020, a 0.3-percent decrease in MCO, 
PIHP, and PAHP expenditures is projected to be a reduction of $1.3 
billion in federal expenditures and of $0.7 billion in state 
expenditures.
    Many other changes in this final rule will have small COI costs for 
MCOs, PIHPs, and PAHPs; however, they are negligible. All COI costs are 
described in section V. of this final rule.
2. Effects on the Medicare and Medicaid Programs
    This final rule may have some positive effect on Medicare, but that 
effect is not quantifiable. Sections 438.62 and 438.208 finalize 
enhanced care planning, transition, and coordination activities. Many 
of these activities will affect dually eligible enrollees. If, as 
expected, those efforts generate savings from more efficient and 
appropriate use of services, then

[[Page 27851]]

Medicare as the primary payer may recognize some benefit.
    The provisions of final part 438 will apply to all states using a 
managed care delivery system for the Medicaid program. Federal matching 
rates are discussed more fully in section VI.B, Overall Impact. This 
final rule will help states fulfill the goals and mission of the 
Medicaid program through better oversight and accountability of their 
programs and will enable them to detect deficiencies and implement 
corrective action more quickly and consistently.

D. Alternatives Considered

    One alternative considered was leaving part 438 as it is today. 
While it has been the guiding regulation for Medicaid managed care 
since its finalization in 2002, many questions and issues have arisen 
in the intervening 13 years due to the current version's lack of 
clarity or detail in some areas. The final revisions to the topics of 
rate setting and enrollment are good examples of this. With no guidance 
in these areas, states have created various standards, leading to 
inconsistency and, in some cases, less than optimal program 
performance. Additionally, many issues have arisen from the evolution 
of managed care in the last 12 years that have rendered parts of parts 
438 nearly obsolete. For example, the existing version gives little 
acknowledgement to the use of electronic means of communication and no 
recognition to the recently created health care coverage options 
offered through the federal and state marketplaces. This creates gaps 
that leave states and managed care plans with unclear, non-existent, or 
confusing guidance and standards for program operation. We believe that 
with consistent standards and clearly defined flexibilities for states, 
programs can develop in ways that not only transform the healthcare 
delivery system and fulfill the mission of the Medicaid program, but 
can improve the health and wellness of Medicaid enrollees. For these 
reasons, we believe that leaving part 438 as it is now is not a viable 
option.
    Another option was to align completely with standards applicable to 
plans in Medicare and/or the Marketplace. Given the high rate of cross 
program participation among the managed care plans in some states, we 
believe it is important to allow managed care plans to take advantage 
of operational efficiencies by aligning part 438 with Medicare and the 
private insurance market wherever possible by creating and implementing 
uniform policies and procedures. Alignment also adds consistency and 
ease of understanding for enrollees as they move between healthcare 
coverage programs as their life circumstances change. For each 
regulatory area where a comparable Medicare or Marketplace practice or 
policy existed, staff evaluated the information against existing 
Medicaid regulations. When differences were identified, they were 
evaluated to determine the benefits and drawbacks to adopting and the 
degree of impact the change would have on the Medicaid population, 
which is often significantly different from Medicare and the 
Marketplace populations. Additionally, as Medicaid is a federal-state 
partnership, we wanted to preserve the flexibility historically 
provided to states in the design and administration of their programs. 
As such, complete alignment was only an option in some provisions, 
while partial alignment was selected in others to recognize and 
accommodate the unique aspects of the Medicaid program.
    We received no public comments on the alternatives considered 
above.
    Regarding quality measurement and improvement (part 438 subpart E), 
two alternatives were considered: (1) Leaving the language as it exists 
today; and (2) expanding the application of the quality strategy from 
Medicaid and CHIP managed care to include services provided FFS. While 
our regulatory language has remained unchanged since 2002, there have 
been significant improvements regarding quality measurement and 
improvement for Medicaid. Under the authority of CHIPRA and the 
Affordable Care Act, we have developed and issued a set of performance 
measures to assess the quality of care received by adults and children 
in the Medicaid and CHIP programs. The National Quality Strategy and 
CMS Quality Strategy now offer national guidance regarding how we move 
forward as a nation to offer better health care, improved 
affordability, and support healthy people and healthy communities. At a 
state level, Medicaid managed care programs have undergone shifts both 
in terms of populations and benefits since 2002. Given these changes, 
we believe that is it necessary and appropriate to revise our 
regulatory language to address needs of the Medicaid programs both 
today and into the future.
    While the role of managed care in both Medicaid has grown since 
2002, we cannot forget that many individuals still receive care through 
a FFS delivery model, and that certain services are still provided FFS 
to individuals otherwise enrolled in managed care programs. We believe 
that, regardless of delivery system, it is important for states to 
measure performance to develop a plan to strengthen and improve the 
quality of care. This led us to propose the expansion of the quality 
strategy to include services delivered FFS. However, the comments 
received highlighted the potential challenges and burden associated 
with this proposal. While we continue to encourage states to measure 
and improve quality for services provided FFS, we understand that 
mandating a comprehensive quality strategy may not be the most 
appropriate approach at this time. Therefore, we determined that the 
most appropriate course of action would be to revise the Medicaid and 
CHIP managed care quality regulations to apply to states contracting 
with MCOs, PIHPs, PAHPs, and select PCCM entities.
    For CHIP, we considered two alternatives: (1) Not regulating; or 
(2) adopting additional Medicaid requirements. CHIPRA applied several 
of the Medicaid managed care standards to CHIP. In response, we 
released two SHOs conveying those requirements to states, but have not 
provided additional guidance. As a result, states do not have clear 
understanding of the expectations of the federal requirements for CHIP 
managed care, and CMS does not have needed information about state 
oversight of managed care plans. Therefore, we determined that 
regulations were appropriate. When deciding whether to adopt all of the 
Medicaid regulations, or only the subset finalized in this regulation, 
we have worked to balance the need for information about state 
oversight of CHIP managed care plans against the administrative burden 
of complying with the final regulations. To that end, we only apply the 
rules that are most important for aligning CHIP managed care with 
Marketplace and Medicaid managed care rules. The scope of the CHIP 
regulations is narrower than the revisions and amendments to the 
Medicaid managed care regulations as discussed throughout section II of 
this final rule.

E. Accounting Statement and Table

    The estimates that appear in the Transfers section of Table 15 
combine both cost savings and transfers between members of society. To 
the extent that the final rule changes provision of medical care, the 
impacts represent cost savings. Otherwise, the rule's impacts represent 
transfers to the federal and state governments from MCOs, PIHPs and 
PAHPs.

[[Page 27852]]

[GRAPHIC] [TIFF OMITTED] TR06MY16.035

List of Subjects

42 CFR Part 431

    Grant programs-health, Health facilities, Medicaid, Privacy, 
Reporting and recordkeeping requirements.

42 CFR Part 433

    Administrative practice and procedure, Child support, Claims, Grant 
programs-health, Medicaid, Reporting and recordkeeping requirements.

42 CFR Part 438

    Grant programs-health, Medicaid, Reporting and recordkeeping 
requirements.

42 CFR Part 440

    Grant programs-health, Medicaid.

42 CFR Part 457

    Administrative practice and procedure, Grant programs-health, 
Health insurance, Reporting and recordkeeping requirements.

42 CFR Part 495

    Administrative practice and procedure, Electronic health records, 
Health facilities, Health professions, Health maintenance organizations 
(HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 431--STATE ORGANIZATION AND GENERAL ADMINISTRATION

0
1. The authority citation for part 431 continues to read as follows:

    Authority: Sec. 1102 of the Social Security Act, (42 U.S.C. 
1302).


0
2. Section 431.200 is amended by revising paragraph (b) to read as 
follows:


Sec.  431.200  Basis and scope.

* * * * *
    (b) Prescribes procedures for an opportunity for a hearing if the 
State agency or non-emergency transportation PAHP (as defined in Sec.  
438.9(a) of this chapter) takes action, as stated in this subpart, to 
suspend, terminate, or reduce services, or of an adverse benefit 
determination by an MCO, PIHP or

[[Page 27853]]

PAHP under subpart F of part 438 of this chapter; and
* * * * *

0
3. Section 431.220 is amended by revising paragraphs (a)(5) and (6) to 
read as follows:


Sec.  431.220  When a hearing is required.

    (a) * * *
    (5) Any MCO, PIHP, or PAHP enrollee who is entitled to a hearing 
under subpart F of part 438 of this chapter.
    (6) Any enrollee in a non-emergency medical transportation PAHP (as 
that term is defined in Sec.  438.9 of this chapter) who has an action 
as stated in this subpart.
* * * * *

0
4. Section 431.244 is amended by--
0
a. Revising paragraphs (f)(1) and (f)(2) introductory text.
0
b. Removing paragraph (f)(3).
    The revisions read as follows:


Sec.  431.244  Hearing decisions.

* * * * *
    (f) * * *
    (1) Ordinarily, within 90 days from the date the enrollee filed an 
MCO, PIHP, or PAHP appeal, not including the number of days the 
enrollee took to subsequently file for a State fair hearing.
    (2) As expeditiously as the enrollee's health condition requires, 
but no later than 3 working days after the agency receives, from the 
MCO, PIHP, or PAHP, the case file and information for any appeal of a 
denial of a service that, as indicated by the MCO, PIHP, or PAHP--
* * * * *

PART 433--STATE FISCAL ADMINISTRATION

0
5. The authority citation for part 433 continues to read as follows:

    Authority: Sec. 1102 of the Social Security Act, (42 U.S.C. 
1302).

0
6. Effective May 6, 2016, Sec.  433.15 is amended by revising paragraph 
(b)(10) to read as follows:


Sec.  433.15  Rates of FFP for administration.

* * * * *
    (b) * * *
    (10) Funds expended for the performance of external quality review 
or the related activities described in Sec.  438.358 of this chapter 
consistent with Sec.  438.370(a) of this chapter: 75 percent; 
consistent with Sec.  438.370(b): 50 percent.

0
7. Section 433.138 is amended by revising paragraph (e) to read as 
follows:


Sec.  433.138  Identifying liable third parties.

* * * * *
    (e) Diagnosis and trauma code edits. Except as specified under 
paragraph (l) of this section, the agency must take action to identify 
those paid claims for Medicaid beneficiaries that contain diagnosis 
codes that are indicative of trauma, or injury, poisoning, and other 
consequences of external causes, for the purpose of determining the 
legal liability of third parties so that the agency may process claims 
under the third party liability payment procedures specified in Sec.  
433.139(b) through (f).
* * * * *

PART 438--MANAGED CARE

0
8. The authority citation for part 438 continues to read as follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).


0
9. Effective May 6, 2016, Sec.  438.370 is revised to read as follows:


Sec.  438.370  Federal financial participation (FFP).

    (a) FFP at the 75 percent rate is available in expenditures for EQR 
(including the production of EQR results) and the EQR-related 
activities set forth in Sec.  438.358 performed on MCOs and conducted 
by EQROs and their subcontractors.
    (b) FFP at the 50 percent rate is available in expenditures for 
EQR-related activities conducted by any entity that does not qualify as 
an EQRO, and for EQR (including the production of EQR results) and EQR-
related activities performed by an EQRO on entities other than MCOs.
    (c) Prior to claiming FFP at the 75 percent rate in accordance with 
paragraph (a) of this section, the State must submit each EQRO contract 
to CMS for review and approval.

0
10. Effective July 5, 2016, subparts A through J are revised to read as 
follows:

Subpart A--General Provisions
Sec.
438.1 Basis and scope.
438.2 Definitions.
438.3 Standard contract requirements.
438.4 Actuarial soundness.
438.5 Rate development standards.
438.6 Special contract provisions related to payment.
438.7 Rate certification submission.
438.8 Medical loss ratio (MLR) standards.
438.9 Provisions that apply to non-emergency medical transportation 
PAHPs.
438.10 Information requirements.
438.12 Provider discrimination prohibited.
438.14 Requirements that apply to MCO, PIHP, PAHP, PCCM, and PCCM 
entity contracts involving Indians, Indian health care providers 
(IHCPs), and Indian managed care entities (IMCEs).
Subpart B--State Responsibilities
438.50 State Plan requirements.
438.52 Choice of MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities.
438.54 Managed care enrollment.
438.56 Disenrollment: Requirements and limitations.
438.58 Conflict of interest safeguards.
438.60 Prohibition of additional payments for services covered under 
MCO, PIHP or PAHP contracts.
438.62 Continued services to enrollees.
438.66 State monitoring requirements.
438.68 Network adequacy standards.
438.70 Stakeholder engagement when LTSS is delivered through a 
managed care program.
438.71 Beneficiary support system.
438.74 State oversight of the minimum MLR requirement.
Subpart C--Enrollee Rights and Protections
438.100 Enrollee rights.
438.102 Provider-enrollee communications.
438.104 Marketing activities.
438.106 Liability for payment.
438.108 Cost sharing.
438.110 Member advisory committee.
438.114 Emergency and poststabilization services.
438.116 Solvency standards.
Subpart D--MCO, PIHP and PAHP standards
438.206 Availability of services.
438.207 Assurance of adequate capacity and services.
438.208 Coordination and continuity of care.
438.210 Coverage and authorization of services.
438.214 Provider selection.
438.224 Confidentiality.
438.228 Grievance and appeal systems.
438.230 Subcontractual relationships and delegation.
438.236 Practice guidelines.
438.242 Health information systems.
Subpart E--Quality Measurement and Improvement; External Quality Review
438.310 Basis, scope, and applicability.
438.320 Definitions.
438.330 Quality assessment and performance improvement program.
438.332 State review of the accreditation status of MCOs, PIHPs and 
PAHPs.
438.334 Medicaid managed care quality rating system.
438.340 Managed care State quality strategy.
438.350 External quality review.
438.352 External quality review protocols.
438.354 Qualifications of external quality review organizations.
438.356 State contract options for external quality review.
438.358 Activities related to external quality review.
438.360 Nonduplication of mandatory activities with Medicare or 
accreditation review.
438.362 Exemption from external quality review.
438.364 External quality review results.
438.370 Federal financial participation (FFP).

[[Page 27854]]

Subpart F--Grievance and Appeal System
438.400 Statutory basis, definitions, and applicability.
438.402 General requirements.
438.404 Timely and adequate notice of adverse benefit determination.
438.406 Handling of grievances and appeals.
438.408 Resolution and notification: Grievances and appeals.
438.410 Expedited resolution of appeals.
438.414 Information about the grievance and appeal system to 
providers and subcontractors.
438.416 Recordkeeping requirements.
438.420 Continuation of benefits while the MCO, PIHP, or PAHP appeal 
and the State fair hearing are pending.
438.424 Effectuation of reversed appeal resolutions.
Subpart G--[Reserved]
Subpart H--Additional Program Integrity Safeguards
438.600 Statutory basis, basic rule, and applicability.
438.602 State responsibilities.
438.604 Data, information, and documentation that must be submitted.
438.606 Source, content, and timing of certification.
438.608 Program integrity requirements under the contract.
438.610 Prohibited affiliations.
Subpart I--Sanctions
438.700 Basis for imposition of sanctions.
438.702 Types of intermediate sanctions.
438.704 Amounts of civil money penalties.
438.706 Special rules for temporary management.
438.708 Termination of an MCO, PCCM, or PCCM entity contract.
438.710 Notice of sanction and pre-termination hearing.
438.722 Disenrollment during termination hearing process.
438.724 Notice to CMS.
438.726 State plan requirement.
438.730 Sanction by CMS: Special rules for MCOs.
Subpart J--Conditions for Federal Financial Participation (FFP)
438.802 Basic requirements.
438.806 Prior approval.
438.808 Exclusion of entities.
438.810 Expenditures for enrollment broker services.
438.812 Costs under risk and nonrisk contracts.
438.816 Expenditures for the beneficiary support system for 
enrollees using LTSS.
438.818 Enrollee encounter data.

Subpart A--General Provisions


Sec.  438.1  Basis and scope.

    (a) Statutory basis. This part is based on the following statutory 
sections:
    (1) Section 1902(a)(4) of the Act requires that States provide for 
methods of administration that the Secretary finds necessary for proper 
and efficient operation of the State plan. The application of the 
requirements of this part to PIHPs and PAHPs that do not meet the 
statutory definition of an MCO or a PCCM is under the authority in 
section 1902(a)(4) of the Act.
    (2) Section 1903(i)(25) of the Act prohibits payment to a State 
unless a State provides enrollee encounter data required by CMS.
    (3) Section 1903(m) of the Act contains requirements that apply to 
comprehensive risk contracts.
    (4) Section 1903(m)(2)(H) of the Act provides that an enrollee who 
loses Medicaid eligibility for not more than 2 months may be enrolled 
in the succeeding month in the same MCO or PCCM if that MCO or PCCM 
still has a contract with the State.
    (5) Section 1905(t) of the Act contains requirements that apply to 
PCCMs.
    (6) Section 1932 of the Act--
    (i) Provides that, with specified exceptions, a State may require 
Medicaid beneficiaries to enroll in MCOs or PCCMs.
    (ii) Establishes the rules that MCOs, PCCMs, the State, and the 
contracts between the State and those entities must meet, including 
compliance with requirements in sections 1903(m) and 1905(t) of the Act 
that are implemented in this part.
    (iii) Establishes protections for enrollees of MCOs and PCCMs.
    (iv) Requires States to develop a quality assessment and 
performance improvement strategy.
    (v) Specifies certain prohibitions aimed at the prevention of fraud 
and abuse.
    (vi) Provides that a State may not enter into contracts with MCOs 
unless it has established intermediate sanctions that it may impose on 
an MCO that fails to comply with specified requirements.
    (vii) Specifies rules for Indian enrollees, Indian health care 
providers, and Indian managed care entities.
    (viii) Makes other minor changes in the Medicaid program.
    (b) Scope. This part sets forth requirements, prohibitions, and 
procedures for the provision of Medicaid services through MCOs, PIHPs, 
PAHPs, PCCMs and PCCM entities. Requirements vary depending on the type 
of entity and on the authority under which the State contracts with the 
entity. Provisions that apply only when the contract is under a 
mandatory managed care program authorized by section 1932(a)(1)(A) of 
the Act are identified as such.


Sec.  438.2  Definitions.

    As used in this part--
    Abuse means as the term is defined in Sec.  455.2 of this chapter.
    Actuary means an individual who meets the qualification standards 
established by the American Academy of Actuaries for an actuary and 
follows the practice standards established by the Actuarial Standards 
Board. In this part, Actuary refers to an individual who is acting on 
behalf of the State when used in reference to the development and 
certification of capitation rates.
    Capitation payment means a payment the State makes periodically to 
a contractor on behalf of each beneficiary enrolled under a contract 
and based on the actuarially sound capitation rate for the provision of 
services under the State plan. The State makes the payment regardless 
of whether the particular beneficiary receives services during the 
period covered by the payment.
    Choice counseling means the provision of information and services 
designed to assist beneficiaries in making enrollment decisions; it 
includes answering questions and identifying factors to consider when 
choosing among managed care plans and primary care providers. Choice 
counseling does not include making recommendations for or against 
enrollment into a specific MCO, PIHP, or PAHP.
    Comprehensive risk contract means a risk contract between the State 
and an MCO that covers comprehensive services, that is, inpatient 
hospital services and any of the following services, or any three or 
more of the following services:
    (1) Outpatient hospital services.
    (2) Rural health clinic services.
    (3) Federally Qualified Health Center (FQHC) services.
    (4) Other laboratory and X-ray services.
    (5) Nursing facility (NF) services.
    (6) Early and periodic screening, diagnostic, and treatment (EPSDT) 
services.
    (7) Family planning services.
    (8) Physician services.
    (9) Home health services.
    Enrollee means a Medicaid beneficiary who is currently enrolled in 
an MCO, PIHP, PAHP, PCCM, or PCCM entity in a given managed care 
program.
    Enrollee encounter data means the information relating to the 
receipt of any item(s) or service(s) by an enrollee under a contract 
between a State and a MCO, PIHP, or PAHP that is subject to the 
requirements of Sec. Sec.  438.242 and 438.818.
    Federally qualified HMO means an HMO that CMS has determined is a 
qualified HMO under section 1310(d) of the PHS Act.
    Fraud means as the term is defined in Sec.  455.2 of this chapter.

[[Page 27855]]

    Health insuring organization (HIO) means a county operated entity, 
that in exchange for capitation payments, covers services for 
beneficiaries--
    (1) Through payments to, or arrangements with, providers;
    (2) Under a comprehensive risk contract with the State; and
    (3) Meets the following criteria--
    (i) First became operational prior to January 1, 1986; or
    (ii) Is described in section 9517(c)(3) of the Omnibus Budget 
Reconciliation Act of 1985 (as amended by section 4734 of the Omnibus 
Budget Reconciliation Act of 1990 and section 205 of the Medicare 
Improvements for Patients and Providers Act of 2008).
    Long-term services and supports (LTSS) means services and supports 
provided to beneficiaries of all ages who have functional limitations 
and/or chronic illnesses that have the primary purpose of supporting 
the ability of the beneficiary to live or work in the setting of their 
choice, which may include the individual's home, a worksite, a 
provider-owned or controlled residential setting, a nursing facility, 
or other institutional setting.
    Managed care organization (MCO) means an entity that has, or is 
seeking to qualify for, a comprehensive risk contract under this part, 
and that is--
    (1) A Federally qualified HMO that meets the advance directives 
requirements of subpart I of part 489 of this chapter; or
    (2) Any public or private entity that meets the advance directives 
requirements and is determined by the Secretary to also meet the 
following conditions:
    (i) Makes the services it provides to its Medicaid enrollees as 
accessible (in terms of timeliness, amount, duration, and scope) as 
those services are to other Medicaid beneficiaries within the area 
served by the entity.
    (ii) Meets the solvency standards of Sec.  438.116.
    Managed care program means a managed care delivery system operated 
by a State as authorized under sections 1915(a), 1915(b), 1932(a), or 
1115(a) of the Act.
    Material adjustment means an adjustment that, using reasonable 
actuarial judgment, has a significant impact on the development of the 
capitation payment such that its omission or misstatement could impact 
a determination whether the development of the capitation rate is 
consistent with generally accepted actuarial principles and practices.
    Network provider means any provider, group of providers, or entity 
that has a network provider agreement with a MCO, PIHP, or PAHP, or a 
subcontractor, and receives Medicaid funding directly or indirectly to 
order, refer or render covered services as a result of the state's 
contract with an MCO, PIHP, or PAHP. A network provider is not a 
subcontractor by virtue of the network provider agreement.
    Nonrisk contract means a contract between the State and a PIHP or 
PAHP under which the contractor--
    (1) Is not at financial risk for changes in utilization or for 
costs incurred under the contract that do not exceed the upper payment 
limits specified in Sec.  447.362 of this chapter; and
    (2) May be reimbursed by the State at the end of the contract 
period on the basis of the incurred costs, subject to the specified 
limits.
    Overpayment means any payment made to a network provider by a MCO, 
PIHP, or PAHP to which the network provider is not entitled to under 
Title XIX of the Act or any payment to a MCO, PIHP, or PAHP by a State 
to which the MCO, PIHP, or PAHP is not entitled to under Title XIX of 
the Act.
    Potential enrollee means a Medicaid beneficiary who is subject to 
mandatory enrollment or may voluntarily elect to enroll in a given MCO, 
PIHP, PAHP, PCCM or PCCM entity, but is not yet an enrollee of a 
specific MCO, PIHP, PAHP, PCCM, or PCCM entity.
    Prepaid ambulatory health plan (PAHP) means an entity that--
    (1) Provides services to enrollees under contract with the State, 
and on the basis of capitation payments, or other payment arrangements 
that do not use State plan payment rates.
    (2) Does not provide or arrange for, and is not otherwise 
responsible for the provision of any inpatient hospital or 
institutional services for its enrollees; and
    (3) Does not have a comprehensive risk contract.
    Prepaid inpatient health plan (PIHP) means an entity that--
    (1) Provides services to enrollees under contract with the State, 
and on the basis of capitation payments, or other payment arrangements 
that do not use State plan payment rates.
    (2) Provides, arranges for, or otherwise has responsibility for the 
provision of any inpatient hospital or institutional services for its 
enrollees; and
    (3) Does not have a comprehensive risk contract.
    Primary care means all health care services and laboratory services 
customarily furnished by or through a general practitioner, family 
physician, internal medicine physician, obstetrician/gynecologist, 
pediatrician, or other licensed practitioner as authorized by the State 
Medicaid program, to the extent the furnishing of those services is 
legally authorized in the State in which the practitioner furnishes 
them.
    Primary care case management means a system under which:
    (1) A primary care case manager (PCCM) contracts with the State to 
furnish case management services (which include the location, 
coordination and monitoring of primary health care services) to 
Medicaid beneficiaries; or
    (2) A PCCM entity contracts with the State to provide a defined set 
of functions.
    Primary care case management entity (PCCM entity) means an 
organization that provides any of the following functions, in addition 
to primary care case management services, for the State:
    (1) Provision of intensive telephonic or face-to-face case 
management, including operation of a nurse triage advice line.
    (2) Development of enrollee care plans.
    (3) Execution of contracts with and/or oversight responsibilities 
for the activities of FFS providers in the FFS program.
    (4) Provision of payments to FFS providers on behalf of the State.
    (5) Provision of enrollee outreach and education activities.
    (6) Operation of a customer service call center.
    (7) Review of provider claims, utilization and practice patterns to 
conduct provider profiling and/or practice improvement.
    (8) Implementation of quality improvement activities including 
administering enrollee satisfaction surveys or collecting data 
necessary for performance measurement of providers.
    (9) Coordination with behavioral health systems/providers.
    (10) Coordination with long-term services and supports systems/
providers.
    Primary care case manager (PCCM) means a physician, a physician 
group practice or, at State option, any of the following:
    (1) A physician assistant.
    (2) A nurse practitioner.
    (3) A certified nurse-midwife.
    Provider means any individual or entity that is engaged in the 
delivery of services, or ordering or referring for those services, and 
is legally authorized to do so by the State in which it delivers the 
services.
    Rate cell means a set of mutually exclusive categories of enrollees 
that is defined by one or more characteristics

[[Page 27856]]

for the purpose of determining the capitation rate and making a 
capitation payment; such characteristics may include age, gender, 
eligibility category, and region or geographic area. Each enrollee 
should be categorized in one of the rate cells for each unique set of 
mutually exclusive benefits under the contract.
    Rating period means a period of 12 months selected by the State for 
which the actuarially sound capitation rates are developed and 
documented in the rate certification submitted to CMS as required by 
Sec.  438.7(a).
    Risk contract means a contract between the State an MCO, PIHP or 
PAHP under which the contractor--
    (1) Assumes risk for the cost of the services covered under the 
contract; and
    (2) Incurs loss if the cost of furnishing the services exceeds the 
payments under the contract.
    Subcontractor means an individual or entity that has a contract 
with an MCO, PIHP, PAHP, or PCCM entity that relates directly or 
indirectly to the performance of the MCO's, PIHP's, PAHP's, or PCCM 
entity's obligations under its contract with the State. A network 
provider is not a subcontractor by virtue of the network provider 
agreement with the MCO, PIHP, or PAHP.
    State means the Single State agency as specified in Sec.  431.10 of 
this chapter.


Sec.  438.3  Standard contract requirements.

    (a) CMS review. The CMS must review and approve all MCO, PIHP, and 
PAHP contracts, including those risk and nonrisk contracts that, on the 
basis of their value, are not subject to the prior approval requirement 
in Sec.  438.806. Proposed final contracts must be submitted in the 
form and manner established by CMS. For States seeking approval of 
contracts prior to a specific effective date, proposed final contracts 
must be submitted to CMS for review no later than 90 days prior to the 
effective date of the contract.
    (b) Entities eligible for comprehensive risk contracts. A State may 
enter into a comprehensive risk contract only with the following:
    (1) An MCO.
    (2) The entities identified in section 1903(m)(2)(B)(i), (ii), and 
(iii) of the Act.
    (3) Community, Migrant, and Appalachian Health Centers identified 
in section 1903(m)(2)(G) of the Act. Unless they qualify for a total 
exemption under section 1903(m)(2)(B) of the Act, these entities are 
subject to the regulations governing MCOs under this part.
    (4) An HIO that arranges for services and became operational before 
January 1986.
    (5) An HIO described in section 9517(c)(3) of the Omnibus Budget 
Reconciliation Act of 1985 (as amended by section 4734(2) of the 
Omnibus Budget Reconciliation Act of 1990).
    (c) Payment. The following requirements apply to the final 
capitation rate and the receipt of capitation payments under the 
contract:
    (1) The final capitation rate for each MCO, PIHP or PAHP must be:
    (i) Specifically identified in the applicable contract submitted 
for CMS review and approval.
    (ii) The final capitation rates must be based only upon services 
covered under the State plan and additional services deemed by the 
State to be necessary to comply with the requirements of subpart K of 
this part (applying parity standards from the Mental Health Parity and 
Addiction Equity Act), and represent a payment amount that is adequate 
to allow the MCO, PIHP or PAHP to efficiently deliver covered services 
to Medicaid-eligible individuals in a manner compliant with contractual 
requirements.
    (2) Capitation payments may only be made by the State and retained 
by the MCO, PIHP or PAHP for Medicaid-eligible enrollees.
    (d) Enrollment discrimination prohibited. Contracts with MCOs, 
PIHPs, PAHPs, PCCMs and PCCM entities must provide as follows:
    (1) The MCO, PIHP, PAHP, PCCM or PCCM entity accepts individuals 
eligible for enrollment in the order in which they apply without 
restriction (unless authorized by CMS), up to the limits set under the 
contract.
    (2) Enrollment is voluntary, except in the case of mandatory 
enrollment programs that meet the conditions set forth in Sec.  
438.50(a).
    (3) The MCO, PIHP, PAHP, PCCM or PCCM entity will not, on the basis 
of health status or need for health care services, discriminate against 
individuals eligible to enroll.
    (4) The MCO, PIHP, PAHP, PCCM or PCCM entity will not discriminate 
against individuals eligible to enroll on the basis of race, color, 
national origin, sex, sexual orientation, gender identity, or 
disability and will not use any policy or practice that has the effect 
of discriminating on the basis of race, color, or national origin, sex, 
sexual orientation gender identity, or disability.
    (e) Services that may be covered by an MCO, PIHP, or PAHP. (1) An 
MCO, PIHP, or PAHP may cover, for enrollees, services that are in 
addition to those covered under the State plan as follows:
    (i) Any services that the MCO, PIHP or PAHP voluntarily agree to 
provide, although the cost of these services cannot be included when 
determining the payment rates under paragraph (c) of this section.
    (ii) Any services necessary for compliance by the MCO, PIHP, or 
PAHP with the requirements of subpart K of this part and only to the 
extent such services are necessary for the MCO, PIHP, or PAHP to comply 
with Sec.  438.910.
    (2) An MCO, PIHP, or PAHP may cover, for enrollees, services or 
settings that are in lieu of services or settings covered under the 
State plan as follows:
    (i) The State determines that the alternative service or setting is 
a medically appropriate and cost effective substitute for the covered 
service or setting under the State plan;
    (ii) The enrollee is not required by the MCO, PIHP, or PAHP to use 
the alternative service or setting;
    (iii) The approved in lieu of services are authorized and 
identified in the MCO, PIHP, or PAHP contract, and will be offered to 
enrollees at the option of the MCO, PIHP, or PAHP; and
    (iv) The utilization and actual cost of in lieu of services is 
taken into account in developing the component of the capitation rates 
that represents the covered State plan services, unless a statute or 
regulation explicitly requires otherwise.
    (f) Compliance with applicable laws and conflict of interest 
safeguards. All contracts with MCOs, PIHPs, PAHPs, PCCMs and PCCM 
entities must:
    (1) Comply with all applicable Federal and State laws and 
regulations including Title VI of the Civil Rights Act of 1964; Title 
IX of the Education Amendments of 1972 (regarding education programs 
and activities); the Age Discrimination Act of 1975; the Rehabilitation 
Act of 1973; the Americans with Disabilities Act of 1990 as amended; 
and section 1557 of the Patient Protection and Affordable Care Act.
    (2) Comply with the conflict of interest safeguards described in 
Sec.  438.58 and with the prohibitions described in section 
1902(a)(4)(C) of the Act applicable to contracting officers, employees, 
or independent contractors.
    (g) Provider-preventable condition requirements. All contracts with 
MCOs, PIHPs and PAHPs must comply with the requirements mandating 
provider identification of provider-preventable conditions as a 
condition of payment, as well as the prohibition against payment for 
provider-preventable conditions as set forth in Sec.  434.6(a)(12) and 
Sec.  447.26 of this chapter. MCOs, PIHPs, and PAHPs, must report all 
identified provider-

[[Page 27857]]

preventable conditions in a form and frequency as specified by the 
State.
    (h) Inspection and audit of records and access to facilities. All 
contracts must provide that the State, CMS, the Office of the Inspector 
General, the Comptroller General, and their designees may, at any time, 
inspect and audit any records or documents of the MCO, PIHP, PAHP, PCCM 
or PCCM entity, or its subcontractors, and may, at any time, inspect 
the premises, physical facilities, and equipment where Medicaid-related 
activities or work is conducted. The right to audit under this section 
exists for 10 years from the final date of the contract period or from 
the date of completion of any audit, whichever is later.
    (i) Physician incentive plans. (1) MCO, PIHP, and PAHP contracts 
must provide for compliance with the requirements set forth in 
Sec. Sec.  422.208 and 422.210 of this chapter.
    (2) In applying the provisions of Sec. Sec.  422.208 and 422.210 of 
this chapter, references to ``MA organization,'' ``CMS,'' and 
``Medicare beneficiaries'' must be read as references to ``MCO, PIHP, 
or PAHP,'' ``State,'' and ``Medicaid beneficiaries,'' respectively.
    (j) Advance directives. (1) All MCO and PIHP contracts must provide 
for compliance with the requirements of Sec.  422.128 of this chapter 
for maintaining written policies and procedures for advance directives, 
as if such regulation applied directly to MCOs and PIHPs.
    (2) All PAHP contracts must provide for compliance with the 
requirements of Sec.  422.128 of this chapter for maintaining written 
policies and procedures for advance directives as if such regulation 
applied directly to PAHPs if the PAHP includes, in its network, any of 
those providers listed in Sec.  489.102(a) of this chapter.
    (3) The MCO, PIHP, or PAHP subject to the requirements of this 
paragraph (j) must provide adult enrollees with written information on 
advance directives policies, and include a description of applicable 
State law.
    (4) The information must reflect changes in State law as soon as 
possible, but no later than 90 days after the effective date of the 
change.
    (k) Subcontracts. All subcontracts must fulfill the requirements of 
this part for the service or activity delegated under the subcontract 
in accordance with Sec.  438.230.
    (l) Choice of network provider. The contract must allow each 
enrollee to choose his or her network provider to the extent possible 
and appropriate.
    (m) Audited financial reports. The contract must require MCOs, 
PIHPs, and PAHPs to submit audited financial reports specific to the 
Medicaid contract on an annual basis. The audit must be conducted in 
accordance with generally accepted accounting principles and generally 
accepted auditing standards.
    (n) Parity in mental health and substance use disorder benefits. 
(1) All MCO contracts, and any PIHP and PAHP contracts providing 
services to MCO enrollees, must provide for services to be delivered in 
compliance with the requirements of subpart K of this part insofar as 
those requirements are applicable.
    (2) Any State providing any services to MCO enrollees using a 
delivery system other than the MCO delivery system must provide 
documentation of how the requirements of subpart K of this part are met 
with the submission of the MCO contract for review and approval under 
paragraph (a) of this section.
    (o) LTSS contract requirements. Any contract with an MCO, PIHP or 
PAHP that includes LTSS as a covered benefit must require that any 
services covered under the contract that could be authorized through a 
waiver under section 1915(c) of the Act or a State plan amendment 
authorized through sections 1915(i) or 1915(k) of the Act be delivered 
in settings consistent with Sec.  441.301(c)(4) of this chapter.
    (p) Special rules for certain HIOs. Contracts with HIOs that began 
operating on or after January 1, 1986, and that the statute does not 
explicitly exempt from requirements in section 1903(m) of the Act, are 
subject to all the requirements of this part that apply to MCOs and 
contracts with MCOs. These HIOs may enter into comprehensive risk 
contracts only if they meet the criteria of paragraph (b) of this 
section.
    (q) Additional rules for contracts with PCCMs. A PCCM contract must 
meet the following requirements:
    (1) Provide for reasonable and adequate hours of operation, 
including 24-hour availability of information, referral, and treatment 
for emergency medical conditions.
    (2) Restrict enrollment to beneficiaries who reside sufficiently 
near one of the PCCM's delivery sites to reach that site within a 
reasonable time using available and affordable modes of transportation.
    (3) Provide for arrangements with, or referrals to, sufficient 
numbers of physicians and other practitioners to ensure that services 
under the contract can be furnished to enrollees promptly and without 
compromise to quality of care.
    (4) Prohibit discrimination in enrollment, disenrollment, and re-
enrollment, based on the beneficiary's health status or need for health 
care services.
    (5) Provide that enrollees have the right to disenroll in 
accordance with Sec.  438.56(c).
    (r) Additional rules for contracts with PCCM entities. In addition 
to the requirements in paragraph (q) of this section, States must 
submit PCCM entity contracts to CMS for review and approval to ensure 
compliance with the provisions of this paragraph (r); Sec.  438.10; and 
Sec.  438.310(c)(2).
    (s) Requirements for MCOs, PIHPs, or PAHPs that provide covered 
outpatient drugs. Contracts that obligate MCOs, PIHPs or PAHPs to 
provide coverage of covered outpatient drugs must include the following 
requirements:
    (1) The MCO, PIHP or PAHP provides coverage of covered outpatient 
drugs as defined in section 1927(k)(2) of the Act, that meets the 
standards for such coverage imposed by section 1927 of the Act as if 
such standards applied directly to the MCO, PIHP, or PAHP.
    (2) The MCO, PIHP, or PAHP reports drug utilization data that is 
necessary for States to bill manufacturers for rebates in accordance 
with section 1927(b)(1)(A) of the Act no later than 45 calendar days 
after the end of each quarterly rebate period. Such utilization 
information must include, at a minimum, information on the total number 
of units of each dosage form, strength, and package size by National 
Drug Code of each covered outpatient drug dispensed or covered by the 
MCO, PIHP, or PAHP.
    (3) The MCO, PIHP or PAHP establishes procedures to exclude 
utilization data for covered outpatient drugs that are subject to 
discounts under the 340B drug pricing program from the reports required 
under paragraph (s)(2) of this section when states do not require 
submission of managed care drug claims data from covered entities 
directly.
    (4) The MCO, PIHP or PAHP must operate a drug utilization review 
program that complies with the requirements described in section 
1927(g) of the Act and 42 CFR part 456, subpart K, as if such 
requirement applied to the MCO, PIHP, or PAHP instead of the State.
    (5) The MCO, PIHP or PAHP must provide a detailed description of 
its drug utilization review program activities to the State on an 
annual basis.
    (6) The MCO, PIHP or PAHP must conduct a prior authorization 
program that complies with the requirements of section 1927(d)(5) of 
the Act, as if such requirements applied to the MCO, PIHP, or PAHP 
instead of the State.

[[Page 27858]]

    (t) Requirements for MCOs, PIHPs, or PAHPs responsible for 
coordinating benefits for dually eligible individuals. In a State that 
enters into a Coordination of Benefits Agreement with Medicare for FFS, 
an MCO, PIHP, or PAHP contract that includes responsibility for 
coordination of benefits for individuals dually eligible for Medicaid 
and Medicare must require the MCO, PIHP, or PAHP to enter into a 
Coordination of Benefits Agreement with Medicare and participate in the 
automated claims crossover process.
    (u) Recordkeeping requirements. MCOs, PIHPs, and PAHPs must retain, 
and require subcontractors to retain, as applicable, the following 
information: enrollee grievance and appeal records in Sec.  438.416, 
base data in Sec.  438.5(c), MLR reports in Sec.  438.8(k), and the 
data, information, and documentation specified in Sec. Sec.  438.604, 
438.606, 438.608, and 438.610 for a period of no less than 10 years.
    (v) Applicability date. Sections 438.3(h) and (q) apply to the 
rating period for contracts with MCOs, PIHPs, PAHPs, PCCMs, and PCCM 
entities beginning on or after July 1, 2017. Until that applicability 
date, states are required to continue to comply with Sec.  438.6(g) and 
(k) contained in the 42 CFR, parts 430 to 481, edition revised as of 
October 1, 2015.


Sec.  438.4  Actuarial soundness.

    (a) Actuarially sound capitation rates defined. Actuarially sound 
capitation rates are projected to provide for all reasonable, 
appropriate, and attainable costs that are required under the terms of 
the contract and for the operation of the MCO, PIHP, or PAHP for the 
time period and the population covered under the terms of the contract, 
and such capitation rates are developed in accordance with the 
requirements in paragraph (b) of this section.
    (b) CMS review and approval of actuarially sound capitation rates. 
Capitation rates for MCOs, PIHPs, and PAHPs must be reviewed and 
approved by CMS as actuarially sound. To be approved by CMS, capitation 
rates must:
    (1) Have been developed in accordance with standards specified in 
Sec.  438.5 and generally accepted actuarial principles and practices. 
Any proposed differences among capitation rates according to covered 
populations must be based on valid rate development standards and not 
based on the rate of Federal financial participation associated with 
the covered populations.
    (2) Be appropriate for the populations to be covered and the 
services to be furnished under the contract.
    (3) Be adequate to meet the requirements on MCOs, PIHPs, and PAHPs 
in Sec. Sec.  438.206, 438.207, and 438.208.
    (4) Be specific to payments for each rate cell under the contract.
    (5) Payments from any rate cell must not cross-subsidize or be 
cross-subsidized by payments for any other rate cell.
    (6) Be certified by an actuary as meeting the applicable 
requirements of this part, including that the rates have been developed 
in accordance with the requirements specified in Sec.  438.3(c)(1)(ii) 
and (e).
    (7) Meet any applicable special contract provisions as specified in 
Sec.  438.6.
    (8) Be provided to CMS in a format and within a timeframe that 
meets requirements in Sec.  438.7.
    (9) Be developed in such a way that the MCO, PIHP, or PAHP would 
reasonably achieve a medical loss ratio standard, as calculated under 
Sec.  438.8, of at least 85 percent for the rate year. The capitation 
rates may be developed in such a way that the MCO, PIHP, or PAHP would 
reasonably achieve a medical loss ratio standard greater than 85 
percent, as calculated under Sec.  438.8, as long as the capitation 
rates are adequate for reasonable, appropriate, and attainable non-
benefit costs.


Sec.  438.5  Rate development standards.

    (a) Definitions. As used in this section and Sec.  438.7(b), the 
following terms have the indicated meanings:
    Budget neutral means a standard for any risk sharing mechanism that 
recognizes both higher and lower expected costs among contracted MCOs, 
PIHPs, or PAHPs under a managed care program and does not create a net 
aggregate gain or loss across all payments under that managed care 
program.
    Prospective risk adjustment means a methodology to account for 
anticipated variation in risk levels among contracted MCOs, PIHPs, or 
PAHPs that is derived from historical experience of the contracted 
MCOs, PIHPs, or PAHPs and applied to rates for the rating period for 
which the certification is submitted.
    Retrospective risk adjustment means a methodology to account for 
variation in risk levels among contracted MCOs, PIHPs, or PAHPs that is 
derived from experience concurrent with the rating period of the 
contracted MCOs, PIHPs, or PAHPs subject to the adjustment and 
calculated at the expiration of the rating period.
    Risk adjustment is a methodology to account for the health status 
of enrollees via relative risk factors when predicting or explaining 
costs of services covered under the contract for defined populations or 
for evaluating retrospectively the experience of MCOs, PIHPs, or PAHPs 
contracted with the State.
    (b) Process and requirements for setting actuarially sound 
capitation rates. In setting actuarially sound capitation rates, the 
State must follow the steps below, in an appropriate order, in 
accordance with this section, or explain why they are not applicable:
    (1) Consistent with paragraph (c) of this section, identify and 
develop the base utilization and price data.
    (2) Consistent with paragraph (d) of this section, develop and 
apply trend factors, including cost and utilization, to base data that 
are developed from actual experience of the Medicaid population or a 
similar population in accordance with generally accepted actuarial 
practices and principles.
    (3) Consistent with paragraph (e) of this section, develop the non-
benefit component of the rate to account for reasonable expenses 
related to MCO, PIHP, or PAHP administration; taxes; licensing and 
regulatory fees; contribution to reserves; risk margin; cost of 
capital; and other operational costs associated with the MCO's, PIHP's, 
or PAHP's provision of State plan services to Medicaid enrollees.
    (4) Consistent with paragraph (f) of this section, make appropriate 
and reasonable adjustments to account for changes to the base data, 
programmatic changes, non-benefit components, and any other adjustment 
necessary to establish actuarially sound rates.
    (5) Take into account the MCO's, PIHP's, or PAHP's past medical 
loss ratio, as calculated and reported under Sec.  438.8, in the 
development of the capitation rates, and consider the projected medical 
loss ratio in accordance with Sec.  438.4(b)(9).
    (6) Consistent with paragraph (g) of this section, if risk 
adjustment is applied, select a risk adjustment methodology that uses 
generally accepted models and apply it in a budget neutral manner 
across all MCOs, PIHPs, or PAHPs in the program to calculate 
adjustments to the payments as necessary.
    (c) Base data. (1) States must provide all the validated encounter 
data, FFS data (as appropriate), and audited financial reports (as 
defined in Sec.  438.3(m)) that demonstrate experience for the 
populations to be served by the MCO, PIHP, or PAHP to the actuary 
developing the capitation rates for at least the three most recent and 
complete years prior to the rating period.

[[Page 27859]]

    (2) States and their actuaries must use the most appropriate data, 
with the basis of the data being no older than from the 3 most recent 
and complete years prior to the rating period, for setting capitation 
rates. Such base data must be derived from the Medicaid population, or, 
if data on the Medicaid population is not available, derived from a 
similar population and adjusted to make the utilization and price data 
comparable to data from the Medicaid population. Data must be in 
accordance with actuarial standards for data quality and an explanation 
of why that specific data is used must be provided in the rate 
certification.
    (3) Exception. (i) States that are unable to base their rates on 
data meeting the qualifications in paragraph (c)(2) of this section 
that the basis of the data be no older than from the 3 most recent and 
complete years prior to the rating period may request approval for an 
exception; the request must describe why an exception is necessary and 
describe the actions the state intends to take to come into compliance 
with those requirements.
    (ii) States that request an exception from the base data standards 
established in this section must set forth a corrective action plan to 
come into compliance with the base data standards no later than 2 years 
from the rating period for which the deficiency was identified.
    (d) Trend. Each trend must be reasonable and developed in 
accordance with generally accepted actuarial principles and practices. 
Trend must be developed primarily from actual experience of the 
Medicaid population or from a similar population.
    (e) Non-benefit component of the rate. The development of the non-
benefit component of the rate must include reasonable, appropriate, and 
attainable expenses related to MCO, PIHP, or PAHP administration, 
taxes, licensing and regulatory fees, contribution to reserves, risk 
margin, cost of capital, and other operational costs associated with 
the provision of services identified in Sec.  438.3(c)(1)(ii) to the 
populations covered under the contract.
    (f) Adjustments. Each adjustment must reasonably support the 
development of an accurate base data set for purposes of rate setting, 
address appropriate programmatic changes, reflect the health status of 
the enrolled population, or reflect non-benefit costs, and be developed 
in accordance with generally accepted actuarial principles and 
practices.
    (g) Risk adjustment. Prospective or retrospective risk adjustment 
methodologies must be developed in a budget neutral manner consistent 
with generally accepted actuarial principles and practices.


Sec.  438.6  Special contract provisions related to payment.

    (a) Definitions. As used in this part, the following terms have the 
indicated meanings:
    Base amount is the starting amount, calculated according to 
paragraph (d)(2) of this section, available for pass-through payments 
to hospitals in a given contract year subject to the schedule in 
paragraph (d)(3) of this section.
    Incentive arrangement means any payment mechanism under which a 
MCO, PIHP, or PAHP may receive additional funds over and above the 
capitation rates it was paid for meeting targets specified in the 
contract.
    Pass-through payment is any amount required by the State to be 
added to the contracted payment rates, and considered in calculating 
the actuarially sound capitation rate, between the MCO, PIHP, or PAHP 
and hospitals, physicians, or nursing facilities that is not for the 
following purposes: A specific service or benefit provided to a 
specific enrollee covered under the contract; a provider payment 
methodology permitted under paragraphs (c)(1)(i) through (iii) of this 
section for services and enrollees covered under the contract; a 
subcapitated payment arrangement for a specific set of services and 
enrollees covered under the contract; GME payments; or FQHC or RHC wrap 
around payments.
    Risk corridor means a risk sharing mechanism in which States and 
MCOs, PIHPs, or PAHPs may share in profits and losses under the 
contract outside of a predetermined threshold amount.
    Withhold arrangement means any payment mechanism under which a 
portion of a capitation rate is withheld from an MCO, PIHP, or PAHP and 
a portion of or all of the withheld amount will be paid to the MCO, 
PIHP, or PAHP for meeting targets specified in the contract. The 
targets for a withhold arrangement are distinct from general 
operational requirements under the contract. Arrangements that withhold 
a portion of a capitation rate for noncompliance with general 
operational requirements are a penalty and not a withhold arrangement.
    (b) Basic requirements. (1) If used in the payment arrangement 
between the State and the MCO, PIHP, or PAHP, all applicable risk-
sharing mechanisms, such as reinsurance, risk corridors, or stop-loss 
limits, must be described in the contract, and must be developed in 
accordance with Sec.  438.4, the rate development standards in Sec.  
438.5, and generally accepted actuarial principles and practices.
    (2) Contracts with incentive arrangements may not provide for 
payment in excess of 105 percent of the approved capitation payments 
attributable to the enrollees or services covered by the incentive 
arrangement, since such total payments will not be considered to be 
actuarially sound. For all incentive arrangements, the contract must 
provide that the arrangement is--
    (i) For a fixed period of time and performance is measured during 
the rating period under the contract in which the incentive arrangement 
is applied.
    (ii) Not to be renewed automatically.
    (iii) Made available to both public and private contractors under 
the same terms of performance.
    (iv) Does not condition MCO, PIHP, or PAHP participation in the 
incentive arrangement on the MCO, PIHP, or PAHP entering into or 
adhering to intergovernmental transfer agreements.
    (v) Necessary for the specified activities, targets, performance 
measures, or quality-based outcomes that support program initiatives as 
specified in the State's quality strategy at Sec.  438.340.
    (3) Contracts that provide for a withhold arrangement must ensure 
that the capitation payment minus any portion of the withhold that is 
not reasonably achievable is actuarially sound as determined by an 
actuary. The total amount of the withhold, achievable or not, must be 
reasonable and take into consideration the MCO's, PIHP's or PAHP's 
financial operating needs accounting for the size and characteristics 
of the populations covered under the contract, as well as the MCO's, 
PIHP's or PAHP's capital reserves as measured by the risk-based capital 
level, months of claims reserve, or other appropriate measure of 
reserves. The data, assumptions, and methodologies used to determine 
the portion of the withhold that is reasonably achievable must be 
submitted as part of the documentation required under Sec.  
438.7(b)(6). For all withhold arrangements, the contract must provide 
that the arrangement is--
    (i) For a fixed period of time and performance is measured during 
the rating period under the contract in which the withhold arrangement 
is applied.
    (ii) Not to be renewed automatically.
    (iii) Made available to both public and private contractors under 
the same terms of performance.

[[Page 27860]]

    (iv) Does not condition MCO, PIHP, or PAHP participation in the 
withhold arrangement on the MCO, PIHP, or PAHP entering into or 
adhering to intergovernmental transfer agreements.
    (v) Necessary for the specified activities, targets, performance 
measures, or quality-based outcomes that support program initiatives as 
specified in the State's quality strategy under Sec.  438.340.
    (c) Delivery system and provider payment initiatives under MCO, 
PIHP, or PAHP contracts--(1) General rule. Except as specified in this 
paragraph (c), in paragraph (d) of this section, in a specific 
provision of Title XIX, or in another regulation implementing a Title 
XIX provision related to payments to providers, that is applicable to 
managed care programs, the State may not direct the MCO's, PIHP's or 
PAHP's expenditures under the contract.
    (i) The State may require the MCO, PIHP or PAHP to implement value-
based purchasing models for provider reimbursement, such as pay for 
performance arrangements, bundled payments, or other service payment 
models intended to recognize value or outcomes over volume of services.
    (ii) The State may require MCOs, PIHPs, or PAHPs to participate in 
a multi-payer or Medicaid-specific delivery system reform or 
performance improvement initiative.
    (iii) The State may require the MCO, PIHP or PAHP to:
    (A) Adopt a minimum fee schedule for network providers that provide 
a particular service under the contract; or
    (B) Provide a uniform dollar or percentage increase for network 
providers that provide a particular service under the contract.
    (C) Adopt a maximum fee schedule for network providers that provide 
a particular service under the contract, so long as the MCO, PIHP, or 
PAHP retains the ability to reasonably manage risk and has discretion 
in accomplishing the goals of the contract.
    (2) Process for approval. (i) All contract arrangements that direct 
the MCO's, PIHP's or PAHP's expenditures under paragraphs (c)(1)(i) 
through (iii) of this section must be developed in accordance with 
Sec.  438.4, the standards specified in Sec.  438.5, generally accepted 
principles and practices, and have written approval prior to 
implementation. To obtain written approval, a state must demonstrate, 
in writing, that the arrangement--
    (A) Is based on the utilization and delivery of services;
    (B) Directs expenditures equally, and using the same terms of 
performance, for a class of providers providing the service under the 
contract;
    (C) Expects to advance at least one of the goals and objectives in 
the quality strategy in Sec.  438.340;
    (D) Has an evaluation plan that measures the degree to which the 
arrangement advances at least one of the goals and objectives in the 
quality strategy in Sec.  438.340;
    (E) Does not condition network provider participation in contract 
arrangements under paragraphs (c)(1)(i) through (iii) of this section 
on the network provider entering into or adhering to intergovernmental 
transfer agreements; and
    (F) May not be renewed automatically.
    (ii) Any contract arrangements that direct the MCO's, PIHP's or 
PAHP's expenditures under paragraphs (c)(1)(i) or (c)(1)(ii) of this 
section must also demonstrate, in writing, that the arrangement--
    (A) Must make participation in the value-based purchasing 
initiative, delivery system reform or performance improvement 
initiative available, using the same terms of performance, to a class 
of providers providing services under the contract related to the 
reform or improvement initiative;
    (B) Must use a common set of performance measures across all of the 
payers and providers;
    (C) May not set the amount or frequency of the expenditures; and
    (D) Does not allow the State to recoup any unspent funds allocated 
for these arrangements from the MCO, PIHP, or PAHP.
    (d) Pass-through payments under MCO, PIHP, and PAHP contracts. (1) 
States may require MCOs, PIHPs, and PAHPs to make pass-through payments 
(as defined in paragraph (a) of this section) to network providers that 
are hospitals, physicians, and nursing facilities under the contract 
subject to the requirements of this paragraph (d). States may not 
require MCOs, PIHPs, and PAHPs to make pass-through payments other than 
those permitted under this paragraph.
    (2) Calculation of the base amount. The base amount of pass-through 
payments is the sum of the results of paragraphs (d)(2)(i) and (ii) of 
this section.
    (i) For inpatient and outpatient hospital services that will be 
provided to eligible populations through the MCO, PIHP, or PAHP 
contracts for the rating period that includes pass-through payments and 
that were provided to the eligible populations under MCO, PIHP, or PAHP 
contracts two years prior to the rating period, the State must 
determine reasonable estimates of the aggregate difference between:
    (A) The amount Medicare FFS would have paid for those inpatient and 
outpatient hospital services utilized by the eligible populations under 
the MCO, PIHP, or PAHP contracts for the 12-month period immediately 
two years prior to the rating period that will include pass-through 
payments; and
    (B) The amount the MCOs, PIHPs, or PAHPs paid (not including pass 
through payments) for those inpatient and outpatient hospital services 
utilized by the eligible populations under MCO, PIHP, or PAHP contracts 
for the 12-month period immediately 2 years prior to the rating period 
that will include pass-through payments.
    (ii) For inpatient and outpatient hospital services that will be 
provided to eligible populations through the MCO, PIHP, or PAHP 
contracts for the rating period that includes pass-through payments and 
that were provided to the eligible populations under Medicaid FFS for 
the 12-month period immediately 2 years prior to the rating period, the 
State must determine reasonable estimates of the aggregate difference 
between:
    (A) The amount Medicare FFS would have paid for those inpatient and 
outpatient hospital services utilized by the eligible populations under 
Medicaid FFS for the 12-month period immediately 2 years prior to the 
rating period that will include pass-through payments; and
    (B) The amount the State paid under Medicaid FFS (not including 
pass through payments) for those inpatient and outpatient hospital 
services utilized by the eligible populations for the 12-month period 
immediately 2 years prior to the rating period that will include pass-
through payments.
    (iii) The base amount must be calculated on an annual basis and is 
recalculated annually.
    (iv) States may calculate reasonable estimates of the aggregate 
differences in paragraphs (d)(2)(i) and (ii) of this section in 
accordance with the upper payment limit requirements in 42 CFR part 
447.
    (3) Schedule for the reduction of the base amount of pass-through 
payments for hospitals under the MCO, PIHP, or PAHP contract. Pass-
through payments for hospitals may be required under the contract but 
must be phased out no longer than on the 10-year schedule, beginning 
with contracts that start on or after July 1, 2017. Pass-through 
payments may not exceed a percentage of the base amount, beginning with 
100 percent for contracts starting on or after July 1, 2017, and 
decreasing by 10

[[Page 27861]]

percentage points each successive year. For contracts beginning on or 
after July 1, 2027, the State cannot require pass-through payments for 
hospitals under a MCO, PIHP, or PAHP contract.
    (4) Documentation of the base amount for pass-through payments to 
hospitals. All contract arrangements that direct pass-through payments 
under the MCO's, PIHP's or PAHP's contract for hospitals must document 
the calculation of the base amount in the rate certification required 
in Sec.  438.7. The documentation must include the following:
    (i) The data, methodologies, and assumptions used to calculate the 
base amount;
    (ii) The aggregate amounts calculated for paragraphs (d)(2)(i)(A), 
(d)(2)(i)(B), (d)(2)(ii)(A), (d)(2)(ii)(B) of this section; and
    (iii) The calculation of the applicable percentage of the base 
amount available for pass-through payments under the schedule in 
paragraph (d)(3) of this section.
    (5) Pass-through payments to physicians or nursing facilities. For 
contracts starting on or after July 1, 2017 through contracts beginning 
on or after July 1, 2021, the State may require pass-through payments 
to physicians and nursing facilities under the MCO, PIHP, or PAHP 
contract. For contracts beginning on or after July 1, 2022, the State 
cannot require pass-through payments for physicians or nursing 
facilities under a MCO, PIHP, or PAHP contract.
    (e) Payments to MCOs and PIHPs for enrollees that are a patient in 
an institution for mental disease. The State may make a monthly 
capitation payment to an MCO or PIHP for an enrollee aged 21-64 
receiving inpatient treatment in an Institution for Mental Diseases, as 
defined in Sec.  435.1010 of this chapter, so long as the facility is a 
hospital providing psychiatric or substance use disorder inpatient care 
or a sub-acute facility providing psychiatric or substance use disorder 
crisis residential services, and length of stay in the IMD is for a 
short term stay of no more than 15 days during the period of the 
monthly capitation payment. The provision of inpatient psychiatric or 
substance use disorder treatment in an IMD must meet the requirements 
for in lieu of services at Sec.  438.3(e)(2)(i) through (iii). For 
purposes of rate setting, the state may use the utilization of services 
provided to an enrollee under this section when developing the 
inpatient psychiatric or substance use disorder component of the 
capitation rate, but must price utilization at the cost of the same 
services through providers included under the State plan.


Sec.  438.7  Rate certification submission.

    (a) CMS review and approval of the rate certification. States must 
submit to CMS for review and approval, all MCO, PIHP, and PAHP rate 
certifications concurrent with the review and approval process for 
contracts as specified in Sec.  438.3(a).
    (b) Documentation. The rate certification must contain the 
following information:
    (1) Base data. A description of the base data used in the rate 
setting process (including the base data requested by the actuary, the 
base data that was provided by the State, and an explanation of why any 
base data requested was not provided by the State) and of how the 
actuary determined which base data set was appropriate to use for the 
rating period.
    (2) Trend. Each trend factor, including trend factors for changes 
in the utilization and price of services, applied to develop the 
capitation rates must be adequately described with enough detail so CMS 
or an actuary applying generally accepted actuarial principles and 
practices can understand and evaluate the following:
    (i) The calculation of each trend used for the rating period and 
the reasonableness of the trend for the enrolled population.
    (ii) Any meaningful difference in how a trend differs between the 
rate cells, service categories, or eligibility categories.
    (3) Non-benefit component of the rate. The development of the non-
benefit component of the rate must be adequately described with enough 
detail so CMS or an actuary applying generally accepted actuarial 
principles and practices can identify each type of non-benefit expense 
that is included in the rate and evaluate the reasonableness of the 
cost assumptions underlying each expense. The actuary may document the 
non-benefit costs according to the types of non-benefit costs under 
Sec.  438.5(e).
    (4) Adjustments. All adjustments used to develop the capitation 
rates must be adequately described with enough detail so that CMS, or 
an actuary applying generally accepted actuarial principles and 
practices, can understand and evaluate all of the following:
    (i) How each material adjustment was developed and the 
reasonableness of the material adjustment for the enrolled population.
    (ii) The cost impact of each material adjustment and the aggregate 
cost impact of non-material adjustments.
    (iii) Where in the rate setting process the adjustment was applied.
    (iv) A list of all non-material adjustments used in the rate 
development process.
    (5) Risk adjustment. (i) All prospective risk adjustment 
methodologies must be adequately described with enough detail so that 
CMS or an actuary applying generally accepted actuarial principles and 
practices can understand and evaluate the following:
    (A) The data, and any adjustments to that data, to be used to 
calculate the adjustment.
    (B) The model, and any adjustments to that model, to be used to 
calculate the adjustment.
    (C) The method for calculating the relative risk factors and the 
reasonableness and appropriateness of the method in measuring the risk 
factors of the respective populations.
    (D) The magnitude of the adjustment on the capitation rate per MCO, 
PIHP, or PAHP.
    (E) An assessment of the predictive value of the methodology 
compared to prior rating periods.
    (F) Any concerns the actuary has with the risk adjustment process.
    (ii) All retrospective risk adjustment methodologies must be 
adequately described with enough detail so that CMS or an actuary 
applying generally accepted actuarial principles and practices can 
understand and evaluate the following:
    (A) The party calculating the risk adjustment.
    (B) The data, and any adjustments to that data, to be used to 
calculate the adjustment.
    (C) The model, and any adjustments to that model, to be used to 
calculate the adjustment.
    (D) The timing and frequency of the application of the risk 
adjustment.
    (E) Any concerns the actuary has with the risk adjustment process.
    (iii) Application of an approved risk adjustment methodology to 
capitation rates does not require a revised rate certification because 
payment of capitation rates as modified by the approved risk adjustment 
methodology must be within the scope of the original rate 
certification. The State must provide to CMS the payment terms updated 
by the application of the risk adjustment methodology consistent with 
Sec.  438.3(c).
    (6) Special contract provisions. A description of any of the 
special contract provisions related to payment in Sec.  438.6 that are 
applied in the contract.
    (c) Rates paid under risk contracts. The State, through its 
actuary, must

[[Page 27862]]

certify the final capitation rate paid per rate cell under each risk 
contract and document the underlying data, assumptions and 
methodologies supporting that specific capitation rate.
    (1) The State may pay each MCO, PIHP or PAHP a capitation rate 
under the contract that is different than the capitation rate paid to 
another MCO, PIHP or PAHP, so long as each capitation rate per rate 
cell that is paid is independently developed and set in accordance with 
this part.
    (2) If the State determines that a retroactive adjustment to the 
capitation rate is necessary, the retroactive adjustment must be 
supported by a rationale for the adjustment and the data, assumptions 
and methodologies used to develop the magnitude of the adjustment must 
be adequately described with enough detail to allow CMS or an actuary 
to determine the reasonableness of the adjustment. These retroactive 
adjustments must be certified by an actuary in a revised rate 
certification and submitted as a contract amendment to be approved by 
CMS. All such adjustments are also subject to Federal timely claim 
filing requirements.
    (3) The State may increase or decrease the capitation rate per rate 
cell, as required in paragraph (c) of this section and Sec.  
438.4(b)(4), up to 1.5 percent without submitting a revised rate 
certification, as required under paragraph (a) of this section. Such 
changes of the capitation rate within the permissible 1.5 percent range 
must be consistent with a modification of the contract as required in 
Sec.  438.3(c).
    (d) Provision of additional information. The State must, upon CMS' 
request, provide additional information, whether part of the rate 
certification or additional supplemental materials, if CMS determines 
that information is pertinent to the approval of the certification 
under this part. The State must identify whether the information 
provided in addition to the rate certification is proffered by the 
State, the actuary, or another party.


Sec.  438.8  Medical loss ratio (MLR) standards.

    (a) Basic rule. The State must ensure, through its contracts 
starting on or after July 1, 2017, that each MCO, PIHP, and PAHP 
calculate and report a MLR in accordance with this section. For multi-
year contracts that do not start in 2017, the State must require the 
MCO, PIHP, or PAHP to calculate and report a MLR for the rating period 
that begins in 2017.
    (b) Definitions. As used in this section, the following terms have 
the indicated meanings:
    Credibility adjustment means an adjustment to the MLR for a 
partially credible MCO, PIHP, or PAHP to account for a difference 
between the actual and target MLRs that may be due to random 
statistical variation.
    Full credibility means a standard for which the experience of an 
MCO, PIHP, or PAHP is determined to be sufficient for the calculation 
of a MLR with a minimal chance that the difference between the actual 
and target medical loss ratio is not statistically significant. An MCO, 
PIHP, or PAHP that is assigned full credibility (or is fully credible) 
will not receive a credibility adjustment to its MLR.
    Member months mean the number of months an enrollee or a group of 
enrollees is covered by an MCO, PIHP, or PAHP over a specified time 
period, such as a year.
    MLR reporting year means a period of 12 months consistent with the 
rating period selected by the State.
    No credibility means a standard for which the experience of an MCO, 
PIHP, or PAHP is determined to be insufficient for the calculation of a 
MLR. An MCO, PIHP, or PAHP that is assigned no credibility (or is non-
credible) will not be measured against any MLR requirements.
    Non-claims costs means those expenses for administrative services 
that are not: Incurred claims (as defined in paragraph (e)(2) of this 
section); expenditures on activities that improve health care quality 
(as defined in paragraph (e)(3) of this section); or licensing and 
regulatory fees, or Federal and State taxes (as defined in paragraph 
(f)(2) of this section).
    Partial credibility means a standard for which the experience of an 
MCO, PIHP, or PAHP is determined to be sufficient for the calculation 
of a MLR but with a non-negligible chance that the difference between 
the actual and target medical loss ratios is statistically significant. 
An MCO, PIHP, or PAHP that is assigned partial credibility (or is 
partially credible) will receive a credibility adjustment to its MLR.
    (c) MLR requirement. If a State elects to mandate a minimum MLR for 
its MCOs, PIHPs, or PAHPs, that minimum MLR must be equal to or higher 
than 85 percent (the standard used for projecting actuarial soundness 
under Sec.  438.4(b)) and the MLR must be calculated and reported for 
each MLR reporting year by the MCO, PIHP, or PAHP, consistent with this 
section.
    (d) Calculation of the MLR. The MLR experienced for each MCO, PIHP, 
or PAHP in a MLR reporting year is the ratio of the numerator (as 
defined in paragraph (e) of this section) to the denominator (as 
defined in paragraph (f) of this section). A MLR may be increased by a 
credibility adjustment, in accordance with paragraph (h) of this 
section.
    (e) Numerator--(1) Required elements. The numerator of an MCO's, 
PIHP's, or PAHP's MLR for a MLR reporting year is the sum of the MCO's, 
PIHP's, or PAHP's incurred claims (as defined in (e)(2) of this 
section); the MCO's, PIHP's, or PAHP's expenditures for activities that 
improve health care quality (as defined in paragraph (e)(3) of this 
section); and fraud reduction activities (as defined in paragraph 
(e)(4) of this section).
    (2) Incurred claims. (i) Incurred claims must include the 
following:
    (A) Direct claims that the MCO, PIHP, or PAHP paid to providers 
(including under capitated contracts with network providers) for 
services or supplies covered under the contract and services meeting 
the requirements of Sec.  438.3(e) provided to enrollees.
    (B) Unpaid claims liabilities for the MLR reporting year, including 
claims reported that are in the process of being adjusted or claims 
incurred but not reported.
    (C) Withholds from payments made to network providers.
    (D) Claims that are recoverable for anticipated coordination of 
benefits.
    (E) Claims payments recoveries received as a result of subrogation.
    (F) Incurred but not reported claims based on past experience, and 
modified to reflect current conditions, such as changes in exposure or 
claim frequency or severity.
    (G) Changes in other claims-related reserves.
    (H) Reserves for contingent benefits and the medical claim portion 
of lawsuits.
    (ii) Amounts that must be deducted from incurred claims include the 
following:
    (A) Overpayment recoveries received from network providers.
    (B) Prescription drug rebates received and accrued.
    (iii) Expenditures that must be included in incurred claims include 
the following:
    (A) The amount of incentive and bonus payments made, or expected to 
be made, to network providers.
    (B) The amount of claims payments recovered through fraud reduction 
efforts, not to exceed the amount of fraud reduction expenses. The 
amount of fraud reduction expenses must not include activities 
specified in paragraph (e)(4) of this section.
    (iv) Amounts that must either be included in or deducted from 
incurred

[[Page 27863]]

claims include, respectively, net payments or receipts related to State 
mandated solvency funds.
    (v) Amounts that must be excluded from incurred claims:
    (A) Non-claims costs, as defined in paragraph (b) of this section, 
which include the following:
    (1) Amounts paid to third party vendors for secondary network 
savings.
    (2) Amounts paid to third party vendors for network development, 
administrative fees, claims processing, and utilization management.
    (3) Amounts paid, including amounts paid to a provider, for 
professional or administrative services that do not represent 
compensation or reimbursement for State plan services or services 
meeting the definition in Sec.  438.3(e) and provided to an enrollee.
    (4) Fines and penalties assessed by regulatory authorities.
    (B) Amounts paid to the State as remittance under paragraph (j) of 
this section.
    (C) Amounts paid to network providers under to Sec.  438.6(d).
    (vi) Incurred claims paid by one MCO, PIHP, or PAHP that is later 
assumed by another entity must be reported by the assuming MCO, PIHP, 
or PAHP for the entire MLR reporting year and no incurred claims for 
that MLR reporting year may be reported by the ceding MCO, PIHP, or 
PAHP.
    (3) Activities that improve health care quality. Activities that 
improve health care quality must be in one of the following categories:
    (i) An MCO, PIHP, or PAHP activity that meets the requirements of 
45 CFR 158.150(b) and is not excluded under 45 CFR 158.150(c).
    (ii) An MCO, PIHP, or PAHP activity related to any EQR-related 
activity as described in Sec.  438.358(b) and (c).
    (iii) Any MCO, PIHP, or PAHP expenditure that is related to Health 
Information Technology and meaningful use, meets the requirements 
placed on issuers found in 45 CFR 158.151, and is not considered 
incurred claims, as defined in paragraph (e)(2) of this section.
    (4) Fraud prevention activities. MCO, PIHP, or PAHP expenditures on 
activities related to fraud prevention as adopted for the private 
market at 45 CFR part 158. Expenditures under this paragraph must not 
include expenses for fraud reduction efforts in paragraph 
(e)(2)(iii)(B) of this section.
    (f) Denominator--(1) Required elements. The denominator of an 
MCO's, PIHP's, or PAHP's MLR for a MLR reporting year must equal the 
adjusted premium revenue. The adjusted premium revenue is the MCO's, 
PIHP's, or PAHP's premium revenue (as defined in paragraph (f)(2) of 
this section) minus the MCO's, PIHP's, or PAHP's Federal, State, and 
local taxes and licensing and regulatory fees (as defined in paragraph 
(f)(3) of this section) and is aggregated in accordance with paragraph 
(i) of this section.
    (2) Premium revenue. Premium revenue includes the following for the 
MLR reporting year:
    (i) State capitation payments, developed in accordance with Sec.  
438.4, to the MCO, PIHP, or PAHP for all enrollees under a risk 
contract approved under Sec.  438.3(a), excluding payments made under 
to Sec.  438.6(d).
    (ii) State-developed one time payments, for specific life events of 
enrollees.
    (iii) Other payments to the MCO, PIHP, or PAHP approved under Sec.  
438.6(b)(3).
    (iv) Unpaid cost-sharing amounts that the MCO, PIHP, or PAHP could 
have collected from enrollees under the contract, except those amounts 
the MCO, PIHP, or PAHP can show it made a reasonable, but unsuccessful, 
effort to collect.
    (v) All changes to unearned premium reserves.
    (vi) Net payments or receipts related to risk sharing mechanisms 
developed in accordance with Sec.  438.5 or Sec.  438.6.
    (3) Federal, State, and local taxes and licensing and regulatory 
fees. Taxes, licensing and regulatory fees for the MLR reporting year 
include:
    (i) Statutory assessments to defray the operating expenses of any 
State or Federal department.
    (ii) Examination fees in lieu of premium taxes as specified by 
State law.
    (iii) Federal taxes and assessments allocated to MCOs, PIHPs, and 
PAHPs, excluding Federal income taxes on investment income and capital 
gains and Federal employment taxes.
    (iv) State and local taxes and assessments including:
    (A) Any industry-wide (or subset) assessments (other than 
surcharges on specific claims) paid to the State or locality directly.
    (B) Guaranty fund assessments.
    (C) Assessments of State or locality industrial boards or other 
boards for operating expenses or for benefits to sick employed persons 
in connection with disability benefit laws or similar taxes levied by 
States.
    (D) State or locality income, excise, and business taxes other than 
premium taxes and State employment and similar taxes and assessments.
    (E) State or locality premium taxes plus State or locality taxes 
based on reserves, if in lieu of premium taxes.
    (v) Payments made by an MCO, PIHP, or PAHP that are otherwise 
exempt from Federal income taxes, for community benefit expenditures as 
defined in 45 CFR 158.162(c), limited to the highest of either:
    (A) Three percent of earned premium; or
    (B) The highest premium tax rate in the State for which the report 
is being submitted, multiplied by the MCO's, PIHP's, or PAHP's earned 
premium in the State.
    (4) Denominator when MCO, PIHP, or PAHP is assumed. The total 
amount of the denominator for a MCO, PIHP, or PAHP which is later 
assumed by another entity must be reported by the assuming MCO, PIHP, 
or PAHP for the entire MLR reporting year and no amount under this 
paragraph for that year may be reported by the ceding MCO, PIHP, or 
PAHP.
    (g) Allocation of expense--(1) General requirements. (i) Each 
expense must be included under only one type of expense, unless a 
portion of the expense fits under the definition of, or criteria for, 
one type of expense and the remainder fits into a different type of 
expense, in which case the expense must be pro-rated between types of 
expenses.
    (ii) Expenditures that benefit multiple contracts or populations, 
or contracts other than those being reported, must be reported on a pro 
rata basis.
    (2) Methods used to allocate expenses. (i) Allocation to each 
category must be based on a generally accepted accounting method that 
is expected to yield the most accurate results.
    (ii) Shared expenses, including expenses under the terms of a 
management contract, must be apportioned pro rata to the contract 
incurring the expense.
    (iii) Expenses that relate solely to the operation of a reporting 
entity, such as personnel costs associated with the adjusting and 
paying of claims, must be borne solely by the reporting entity and are 
not to be apportioned to the other entities.
    (h) Credibility adjustment. (1) A MCO, PIHP, or PAHP may add a 
credibility adjustment to a calculated MLR if the MLR reporting year 
experience is partially credible. The credibility adjustment is added 
to the reported MLR calculation before calculating any remittances, if 
required by the State as described in paragraph (j) of this section.
    (2) A MCO, PIHP, or PAHP may not add a credibility adjustment to a 
calculated MLR if the MLR reporting year experience is fully credible.

[[Page 27864]]

    (3) If a MCO's, PIHP's, or PAHP's experience is non-credible, it is 
presumed to meet or exceed the MLR calculation standards in this 
section.
    (4) On an annual basis, CMS will publish base credibility factors 
for MCOs, PIHPs, and PAHPs that are developed according to the 
following methodology:
    (i) CMS will use the most recently available and complete managed 
care encounter data or FFS claims data, and enrollment data, reported 
by the states to CMS. This data may cover more than 1 year of 
experience.
    (ii) CMS will calculate the credibility adjustment so that a MCO, 
PIHP, or PAHP receiving a capitation payment that is estimated to have 
a medical loss ratio of 85 percent would be expected to experience a 
loss ratio less than 85 percent 1 out of every 4 years, or 25 percent 
of the time.
    (iii) The minimum number of member months necessary for a MCO's, 
PIHP's, or PAHP's medical loss ratio to be determined at least 
partially credible will be set so that the credibility adjustment would 
not exceed 10 percent for any partially credible MCO, PIHP, or PAHP. 
Any MCO, PIHP, or PAHP with enrollment less than this number of member 
months will be determined non-credible.
    (iv) The minimum number of member months necessary for an MCO's, 
PIHP's, or PAHP's medical loss ratio to be determined fully credible 
will be set so that the minimum credibility adjustment for any 
partially credible MCO, PIHP, or PAHP would be greater than 1 percent. 
Any MCO, PIHP, or PAHP with enrollment greater than this number of 
member months will be determined to be fully credible.
    (v) A MCO, PIHP, or PAHP with a number of enrollee member months 
between the levels established for non-credible and fully credible 
plans will be deemed partially credible, and CMS will develop 
adjustments, using linear interpolation, based on the number of 
enrollee member months.
    (vi) CMS may adjust the number of enrollee member months necessary 
for a MCO's, PIHP's, or PAHP's experience to be non-credible, partially 
credible, or fully credible so that the standards are rounded for the 
purposes of administrative simplification. The number of member months 
will be rounded to 1,000 or a different degree of rounding as 
appropriate to ensure that the credibility thresholds are consistent 
with the objectives of this regulation.
    (i) Aggregation of data. MCOs, PIHPs, or PAHPs will aggregate data 
for all Medicaid eligibility groups covered under the contract with the 
State unless the State requires separate reporting and a separate MLR 
calculation for specific populations.
    (j) Remittance to the State if specific MLR is not met. If required 
by the State, a MCO, PIHP, or PAHP must provide a remittance for an MLR 
reporting year if the MLR for that MLR reporting year does not meet the 
minimum MLR standard of 85 percent or higher if set by the State as 
described in paragraph (c) of this section.
    (k) Reporting requirements. (1) The State, through its contracts, 
must require each MCO, PIHP, or PAHP to submit a report to the State 
that includes at least the following information for each MLR reporting 
year:
    (i) Total incurred claims.
    (ii) Expenditures on quality improving activities.
    (iii) Expenditures related to activities compliant with Sec.  
438.608(a)(1) through (5), (7), (8) and (b).
    (iv) Non-claims costs.
    (v) Premium revenue.
    (vi) Taxes, licensing and regulatory fees.
    (vii) Methodology(ies) for allocation of expenditures.
    (viii) Any credibility adjustment applied.
    (ix) The calculated MLR.
    (x) Any remittance owed to the State, if applicable.
    (xi) A comparison of the information reported in this paragraph 
with the audited financial report required under Sec.  438.3(m).
    (xii) A description of the aggregation method used under paragraph 
(i) of this section.
    (xiii) The number of member months.
    (2) A MCO, PIHP, or PAHP must submit the report required in 
paragraph (k)(1) of this section in a timeframe and manner determined 
by the State, which must be within 12 months of the end of the MLR 
reporting year.
    (3) MCOs, PIHPs, or PAHPs must require any third party vendor 
providing claims adjudication activities to provide all underlying data 
associated with MLR reporting to that MCO, PIHP, or PAHP within 180 
days of the end of the MLR reporting year or within 30 days of being 
requested by the MCO, PIHP, or PAHP, whichever comes sooner, regardless 
of current contractual limitations, to calculate and validate the 
accuracy of MLR reporting.
    (l) Newer experience. A State, in its discretion, may exclude a 
MCO, PIHP, or PAHP that is newly contracted with the State from the 
requirements in this section for the first year of the MCO's, PIHP's, 
or PAHP's operation. Such MCOs, PIHPs, or PAHPs must be required to 
comply with the requirements in this section during the next MLR 
reporting year in which the MCO, PIHP, or PAHP is in business with the 
State, even if the first year was not a full 12 months.
    (m) Recalculation of MLR. In any instance where a State makes a 
retroactive change to the capitation payments for a MLR reporting year 
where the report has already been submitted to the State, the MCO, 
PIHP, or PAHP must re-calculate the MLR for all MLR reporting years 
affected by the change and submit a new report meeting the requirements 
in paragraph (k) of this section.
    (n) Attestation. MCOs, PIHPs, and PAHPs must attest to the accuracy 
of the calculation of the MLR in accordance with requirements of this 
section when submitting the report required under paragraph (k) of this 
section.


Sec.  438.9  Provisions that apply to non-emergency medical 
transportation PAHPs.

    (a) For purposes of this section, Non-Emergency Medical 
Transportation (NEMT) PAHP means an entity that provides only NEMT 
services to enrollees under contract with the State, and on the basis 
of prepaid capitation payments, or other payment arrangements that do 
not use State plan payment rates.
    (b) Unless listed in this paragraph (b), a requirement of this part 
does not apply to NEMT PAHPs, NEMT PAHP contracts, or States in 
connection with a NEMT PAHP. The following requirements and options 
apply to NEMT PAHPs, NEMT PAHP contracts, and States in connection with 
NEMT PAHPs, to the same extent that they apply to PAHPs, PAHP 
contracts, and States in connection with PAHPs.
    (1) All contract provisions in Sec.  438.3 except requirements for:
    (i) Physician incentive plans at Sec.  438.3(i).
    (ii) Advance directives at Sec.  438.3(j).
    (iii) LTSS requirements at Sec.  438.3(o).
    (iv) MHPAEA at Sec.  438.3(n).
    (2) The actuarial soundness requirements in Sec.  438.4.
    (3) The information requirements in Sec.  438.10.
    (4) The provision against provider discrimination in Sec.  438.12.
    (5) The State responsibility provisions in Sec. Sec.  438.56, 
438.58, 438.60, 438.62(a), and 438.818.
    (6) The provisions on enrollee rights and protections in subpart C 
of this part except for Sec. Sec.  438.110 and 438.114.
    (7) The PAHP standards in Sec. Sec.  438.206(b)(1), 438.210, 
438.214, 438.224, 438.230, and 438.242.
    (8) An enrollee's right to a State fair hearing under subpart E of 
part 431 of this chapter.

[[Page 27865]]

    (9) Prohibitions against affiliations with individuals debarred or 
excluded by Federal agencies in Sec.  438.610.
    (10) Requirements relating to contracts involving Indians, Indian 
Health Care Providers, and Indian managed care entities in Sec.  
438.14.


Sec.  438.10  Information requirements.

    (a) Definitions. As used in this section, the following terms have 
the indicated meanings:
    Limited English proficient (LEP) means potential enrollees and 
enrollees who do not speak English as their primary language and who 
have a limited ability to read, write, speak, or understand English may 
be LEP and may be eligible to receive language assistance for a 
particular type of service, benefit, or encounter.
    Prevalent means a non-English language determined to be spoken by a 
significant number or percentage of potential enrollees and enrollees 
that are limited English proficient.
    Readily accessible means electronic information and services which 
comply with modern accessibility standards such as section 508 
guidelines, section 504 of the Rehabilitation Act, and W3C's Web 
Content Accessibility Guidelines (WCAG) 2.0 AA and successor versions.
    (b) Applicability. The provisions of this section apply to all 
managed care programs which operate under any authority in the Act.
    (c) Basic rules. (1) Each State, enrollment broker, MCO, PIHP, 
PAHP, PCCM, and PCCM entity must provide all required information in 
this section to enrollees and potential enrollees in a manner and 
format that may be easily understood and is readily accessible by such 
enrollees and potential enrollees.
    (2) The State must utilize its beneficiary support system required 
in Sec.  438.71.
    (3) The State must operate a Web site that provides the content, 
either directly or by linking to individual MCO, PIHP, PAHP, or PCCM 
entity Web sites, specified in paragraphs (g), (h), and (i) of this 
section.
    (4) For consistency in the information provided to enrollees, the 
State must develop and require each MCO, PIHP, PAHP and PCCM entity to 
use:
    (i) Definitions for managed care terminology, including appeal, co-
payment, durable medical equipment, emergency medical condition, 
emergency medical transportation, emergency room care, emergency 
services, excluded services, grievance, habilitation services and 
devices, health insurance, home health care, hospice services, 
hospitalization, hospital outpatient care, medically necessary, 
network, non-participating provider, physician services, plan, 
preauthorization, participating provider, premium, prescription drug 
coverage, prescription drugs, primary care physician, primary care 
provider, provider, rehabilitation services and devices, skilled 
nursing care, specialist, and urgent care; and
    (ii) Model enrollee handbooks and enrollee notices.
    (5) The State must ensure, through its contracts, that each MCO, 
PIHP, PAHP and PCCM entity provides the required information in this 
section to each enrollee.
    (6) Enrollee information required in this section may not be 
provided electronically by the State, MCO, PIHP, PAHP, PCCM, or PCCM 
entity unless all of the following are met:
    (i) The format is readily accessible;
    (ii) The information is placed in a location on the State, MCO's, 
PIHP's, PAHP's, or PCCM's, or PCCM entity's Web site that is prominent 
and readily accessible;
    (iii) The information is provided in an electronic form which can 
be electronically retained and printed;
    (iv) The information is consistent with the content and language 
requirements of this section; and
    (v) The enrollee is informed that the information is available in 
paper form without charge upon request and provides it upon request 
within 5 business days.
    (7) Each MCO, PIHP, PAHP, and PCCM entity must have in place 
mechanisms to help enrollees and potential enrollees understand the 
requirements and benefits of the plan.
    (d) Language and format. The State must:
    (1) Establish a methodology for identifying the prevalent non-
English languages spoken by enrollees and potential enrollees 
throughout the State, and in each MCO, PIHP, PAHP, or PCCM entity 
service area.
    (2) Make oral interpretation available in all languages and written 
translation available in each prevalent non-English language. All 
written materials for potential enrollees must include taglines in the 
prevalent non-English languages in the State, as well as large print, 
explaining the availability of written translations or oral 
interpretation to understand the information provided and the toll-free 
telephone number of the entity providing choice counseling services as 
required by Sec.  438.71(a). Large print means printed in a font size 
no smaller than 18 point.
    (3) Require each MCO, PIHP, PAHP, and PCCM entity to make its 
written materials that are critical to obtaining services, including, 
at a minimum, provider directories, enrollee handbooks, appeal and 
grievance notices, and denial and termination notices, available in the 
prevalent non-English languages in its particular service area. Written 
materials must also be made available in alternative formats upon 
request of the potential enrollee or enrollee at no cost. Auxiliary 
aids and services must also be made available upon request of the 
potential enrollee or enrollee at no cost. Written materials must 
include taglines in the prevalent non-English languages in the state, 
as well as large print, explaining the availability of written 
translation or oral interpretation to understand the information 
provided and the toll-free and TTY/TDY telephone number of the MCO's, 
PIHP's, PAHP's or PCCM entity's member/customer service unit. Large 
print means printed in a font size no smaller than 18 point.
    (4) Make interpretation services available to each potential 
enrollee and require each MCO, PIHP, PAHP, and PCCM entity to make 
those services available free of charge to each enrollee. This includes 
oral interpretation and the use of auxiliary aids such as TTY/TDY and 
American Sign Language. Oral interpretation requirements apply to all 
non-English languages, not just those that the State identifies as 
prevalent.
    (5) Notify potential enrollees, and require each MCO, PIHP, PAHP, 
and PCCM entity to notify its enrollees--
    (i) That oral interpretation is available for any language and 
written translation is available in prevalent languages;
    (ii) That auxiliary aids and services are available upon request 
and at no cost for enrollees with disabilities; and
    (iii) How to access the services in paragraphs (d)(5)(i) and (ii) 
of this section.
    (6) Provide, and require MCOs, PIHPs, PAHPs, PCCMs, and PCCM 
entities to provide, all written materials for potential enrollees and 
enrollees consistent with the following:
    (i) Use easily understood language and format.
    (ii) Use a font size no smaller than 12 point.
    (iii) Be available in alternative formats and through the provision 
of auxiliary aids and services in an appropriate manner that takes into 
consideration the special needs of enrollees or potential enrollees 
with disabilities or limited English proficiency.
    (iv) Include a large print tagline and information on how to 
request auxiliary aids and services, including the

[[Page 27866]]

provision of the materials in alternative formats. Large print means 
printed in a font size no smaller than 18 point.
    (e) Information for potential enrollees. (1) The State or its 
contracted representative must provide the information specified in 
paragraph (e)(2) of this section to each potential enrollee, either in 
paper or electronic form as follows:
    (i) At the time the potential enrollee first becomes eligible to 
enroll in a voluntary managed care program, or is first required to 
enroll in a mandatory managed care program; and
    (ii) Within a timeframe that enables the potential enrollee to use 
the information in choosing among available MCOs, PIHPs, PAHPs, PCCMs, 
or PCCM entities.
    (2) The information for potential enrollees must include, at a 
minimum, all of the following:
    (i) Information about the potential enrollee's right to disenroll 
consistent with the requirements of Sec.  438.56 and which explains 
clearly the process for exercising this disenrollment right, as well as 
the alternatives available to the potential enrollee based on their 
specific circumstance;
    (ii) The basic features of managed care;
    (iii) Which populations are excluded from enrollment, subject to 
mandatory enrollment, or free to enroll voluntarily in the program. For 
mandatory and voluntary populations, the length of the enrollment 
period and all disenrollment opportunities available to the enrollee 
must also be specified;
    (iv) The service area covered by each MCO, PIHP, PAHP, PCCM, or 
PCCM entity;
    (v) Covered benefits including:
    (A) Which benefits are provided by the MCO, PIHP, or PAHP; and
    (B) Which, if any, benefits are provided directly by the State.
    (C) For a counseling or referral service that the MCO, PIHP, or 
PAHP does not cover because of moral or religious objections, the State 
must provide information about where and how to obtain the service;
    (vi) The provider directory and formulary information required in 
paragraphs (h) and (i) of this section;
    (vii) Any cost-sharing that will be imposed by the MCO, PIHP, PAHP, 
PCCM, or PCCM entity consistent with those set forth in the State plan;
    (viii) The requirements for each MCO, PIHP or PAHP to provide 
adequate access to covered services, including the network adequacy 
standards established in Sec.  438.68;
    (ix) The MCO, PIHP, PAHP, PCCM and PCCM entity's responsibilities 
for coordination of enrollee care; and
    (x) To the extent available, quality and performance indicators for 
each MCO, PIHP, PAHP and PCCM entity, including enrollee satisfaction.
    (f) Information for all enrollees of MCOs, PIHPs, PAHPs, and PCCM 
entities: General requirements. (1) The MCO, PIHP, PAHP and, when 
appropriate, the PCCM entity, must make a good faith effort to give 
written notice of termination of a contracted provider, within 15 
calendar days after receipt or issuance of the termination notice, to 
each enrollee who received his or her primary care from, or was seen on 
a regular basis by, the terminated provider.
    (2) The State must notify all enrollees of their right to disenroll 
consistent with the requirements of Sec.  438.56 at least annually. 
Such notification must clearly explain the process for exercising this 
disenrollment right, as well as the alternatives available to the 
enrollee based on their specific circumstance. For States that choose 
to restrict disenrollment for periods of 90 days or more, States must 
send the notice no less than 60 calendar days before the start of each 
enrollment period.
    (3) The MCO, PIHP, PAHP and, when appropriate, the PCCM entity must 
make available, upon request, any physician incentive plans in place as 
set forth in Sec.  438.3(i).
    (g) Information for enrollees of MCOs, PIHPs, PAHPs and PCCM 
entities--Enrollee handbook. (1) Each MCO, PIHP, PAHP and PCCM entity 
must provide each enrollee an enrollee handbook, within a reasonable 
time after receiving notice of the beneficiary's enrollment, which 
serves a similar function as the summary of benefits and coverage 
described in 45 CFR 147.200(a).
    (2) The content of the enrollee handbook must include information 
that enables the enrollee to understand how to effectively use the 
managed care program. This information must include at a minimum:
    (i) Benefits provided by the MCO, PIHP, PAHP or PCCM entity.
    (ii) How and where to access any benefits provided by the State, 
including any cost sharing, and how transportation is provided.
    (A) In the case of a counseling or referral service that the MCO, 
PIHP, PAHP, or PCCM entity does not cover because of moral or religious 
objections, the MCO, PIHP, PAHP, or PCCM entity must inform enrollees 
that the service is not covered by the MCO, PIHP, PAHP, or PCCM entity.
    (B) The MCO, PIHP, PAHP, or PCCM entity must inform enrollees how 
they can obtain information from the State about how to access the 
services described in paragraph (g)(2)(i)(A) of this section.
    (iii) The amount, duration, and scope of benefits available under 
the contract in sufficient detail to ensure that enrollees understand 
the benefits to which they are entitled.
    (iv) Procedures for obtaining benefits, including any requirements 
for service authorizations and/or referrals for specialty care and for 
other benefits not furnished by the enrollee's primary care provider.
    (v) The extent to which, and how, after-hours and emergency 
coverage are provided, including:
    (A) What constitutes an emergency medical condition and emergency 
services.
    (B) The fact that prior authorization is not required for emergency 
services.
    (C) The fact that, subject to the provisions of this section, the 
enrollee has a right to use any hospital or other setting for emergency 
care.
    (vi) Any restrictions on the enrollee's freedom of choice among 
network providers.
    (vii) The extent to which, and how, enrollees may obtain benefits, 
including family planning services and supplies from out-of-network 
providers. This includes an explanation that the MCO, PIHP, or PAHP 
cannot require an enrollee to obtain a referral before choosing a 
family planning provider.
    (viii) Cost sharing, if any is imposed under the State plan.
    (ix) Enrollee rights and responsibilities, including the elements 
specified in Sec.  438.100.
    (x) The process of selecting and changing the enrollee's primary 
care provider.
    (xi) Grievance, appeal, and fair hearing procedures and timeframes, 
consistent with subpart F of this part, in a State-developed or State-
approved description. Such information must include:
    (A) The right to file grievances and appeals.
    (B) The requirements and timeframes for filing a grievance or 
appeal.
    (C) The availability of assistance in the filing process.
    (D) The right to request a State fair hearing after the MCO, PIHP 
or PAHP has made a determination on an enrollee's appeal which is 
adverse to the enrollee.
    (E) The fact that, when requested by the enrollee, benefits that 
the MCO, PIHP, or PAHP seeks to reduce or terminate will continue if 
the enrollee files an appeal or a request for State fair hearing within 
the timeframes specified for filing, and that the enrollee may,

[[Page 27867]]

consistent with state policy, be required to pay the cost of services 
furnished while the appeal or state fair hearing is pending if the 
final decision is adverse to the enrollee.
    (xii) How to exercise an advance directive, as set forth in Sec.  
438.3(j). For PAHPs, information must be provided only to the extent 
that the PAHP includes any of the providers described in Sec.  
489.102(a) of this chapter.
    (xiii) How to access auxiliary aids and services, including 
additional information in in alternative formats or languages.
    (xiv) The toll-free telephone number for member services, medical 
management, and any other unit providing services directly to 
enrollees.
    (xv) Information on how to report suspected fraud or abuse;
    (xvi) Any other content required by the State.
    (3) Information required by this paragraph to be provided by a MCO, 
PIHP, PAHP or PCCM entity will be considered to be provided if the MCO, 
PIHP, PAHP or PCCM entity:
    (i) Mails a printed copy of the information to the enrollee's 
mailing address;
    (ii) Provides the information by email after obtaining the 
enrollee's agreement to receive the information by email;
    (iii) Posts the information on the Web site of the MCO, PIHP, PAHP 
or PCCM entity and advises the enrollee in paper or electronic form 
that the information is available on the Internet and includes the 
applicable Internet address, provided that enrollees with disabilities 
who cannot access this information online are provided auxiliary aids 
and services upon request at no cost; or
    (iv) Provides the information by any other method that can 
reasonably be expected to result in the enrollee receiving that 
information.
    (4) The MCO, PIHP, PAHP, or PCCM entity must give each enrollee 
notice of any change that the State defines as significant in the 
information specified in this paragraph (g), at least 30 days before 
the intended effective date of the change.
    (h) Information for all enrollees of MCOs, PIHPs, PAHPs, and PCCM 
entities--Provider Directory. (1) Each MCO, PIHP, PAHP, and when 
appropriate, the PCCM entity, must make available in paper form upon 
request and electronic form, the following information about its 
network providers:
    (i) The provider's name as well as any group affiliation.
    (ii) Street address(es).
    (iii) Telephone number(s).
    (iv) Web site URL, as appropriate.
    (v) Specialty, as appropriate.
    (vi) Whether the provider will accept new enrollees.
    (vii) The provider's cultural and linguistic capabilities, 
including languages (including American Sign Language) offered by the 
provider or a skilled medical interpreter at the provider's office, and 
whether the provider has completed cultural competence training.
    (viii) Whether the provider's office/facility has accommodations 
for people with physical disabilities, including offices, exam room(s) 
and equipment.
    (2) The provider directory must include the information in 
paragraph (h)(1) of this section for each of the following provider 
types covered under the contract:
    (i) Physicians, including specialists;
    (ii) Hospitals;
    (iii) Pharmacies;
    (iv) Behavioral health providers; and
    (v) LTSS providers, as appropriate.
    (3) Information included in a paper provider directory must be 
updated at least monthly and electronic provider directories must be 
updated no later than 30 calendar days after the MCO, PIHP, PAHP or 
PCCM entity receives updated provider information.
    (4) Provider directories must be made available on the MCO's, 
PIHP's, PAHP's, or, if applicable, PCCM entity's Web site in a machine 
readable file and format as specified by the Secretary.
    (i) Information for all enrollees of MCOs, PIHPs, PAHPs, and PCCM 
entities: Formulary. Each MCO, PIHP, PAHP, and when appropriate, PCCM 
entity, must make available in electronic or paper form, the following 
information about its formulary:
    (1) Which medications are covered (both generic and name brand).
    (2) What tier each medication is on.
    (3) Formulary drug lists must be made available on the MCO's, 
PIHP's, PAHP's, or, if applicable, PCCM entity's Web site in a machine 
readable file and format as specified by the Secretary.
    (j) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities 
beginning on or after July 1, 2017. Until that applicability date, 
states are required to continue to comply with Sec.  438.10 contained 
in the 42 CFR parts 430 to 481, edition revised as of October 1, 2015.


Sec.  438.12  Provider discrimination prohibited.

    (a) General rules. (1) An MCO, PIHP, or PAHP may not discriminate 
in the participation, reimbursement, or indemnification of any provider 
who is acting within the scope of his or her license or certification 
under applicable State law, solely on the basis of that license or 
certification. If an MCO, PIHP, or PAHP declines to include individual 
or groups of providers in its provider network, it must give the 
affected providers written notice of the reason for its decision.
    (2) In all contracts with network providers, an MCO, PIHP, or PAHP 
must comply with the requirements specified in Sec.  438.214.
    (b) Construction. Paragraph (a) of this section may not be 
construed to--
    (1) Require the MCO, PIHP, or PAHP to contract with providers 
beyond the number necessary to meet the needs of its enrollees;
    (2) Preclude the MCO, PIHP, or PAHP from using different 
reimbursement amounts for different specialties or for different 
practitioners in the same specialty; or
    (3) Preclude the MCO, PIHP, or PAHP from establishing measures that 
are designed to maintain quality of services and control costs and are 
consistent with its responsibilities to enrollees.


Sec.  438.14  Requirements that apply to MCO, PIHP, PAHP, PCCM, and 
PCCM entity contracts involving Indians, Indian health care providers 
(IHCPs), and Indian managed care entities (IMCEs).

    (a) Definitions. As used in this section, the following terms have 
the indicated meanings:
    Indian means any individual defined at 25 U.S.C. 1603(13), 
1603(28), or 1679(a), or who has been determined eligible as an Indian, 
under 42 CFR 136.12. This means the individual:
    (i) Is a member of a Federally recognized Indian tribe;
    (ii) Resides in an urban center and meets one or more of the four 
criteria:
    (A) Is a member of a tribe, band, or other organized group of 
Indians, including those tribes, bands, or groups terminated since 1940 
and those recognized now or in the future by the State in which they 
reside, or who is a descendant, in the first or second degree, of any 
such member;
    (B) Is an Eskimo or Aleut or other Alaska Native;
    (C) Is considered by the Secretary of the Interior to be an Indian 
for any purpose; or
    (D) Is determined to be an Indian under regulations issued by the 
Secretary;
    (iii) Is considered by the Secretary of the Interior to be an 
Indian for any purpose; or
    (iv) Is considered by the Secretary of Health and Human Services to 
be an Indian for purposes of eligibility for Indian health care 
services, including as

[[Page 27868]]

a California Indian, Eskimo, Aleut, or other Alaska Native.
    Indian health care provider (IHCP) means a health care program 
operated by the Indian Health Service (IHS) or by an Indian Tribe, 
Tribal Organization, or Urban Indian Organization (otherwise known as 
an I/T/U) as those terms are defined in section 4 of the Indian Health 
Care Improvement Act (25 U.S.C. 1603).
    Indian managed care entity (IMCE) means a MCO, PIHP, PAHP, PCCM, or 
PCCM entity that is controlled (within the meaning of the last sentence 
of section 1903(m)(1)(C) of the Act) by the Indian Health Service, a 
Tribe, Tribal Organization, or Urban Indian Organization, or a 
consortium, which may be composed of one or more Tribes, Tribal 
Organizations, or Urban Indian Organizations, and which also may 
include the Service.
    (b) Network and coverage requirements. All contracts between a 
State and a MCO, PIHP, PAHP, and PCCM entity, to the extent that the 
PCCM entity has a provider network, which enroll Indians must:
    (1) Require the MCO, PIHP, PAHP, or PCCM entity to demonstrate that 
there are sufficient IHCPs participating in the provider network of the 
MCO, PIHP, PAHP, or PCCM entity to ensure timely access to services 
available under the contract from such providers for Indian enrollees 
who are eligible to receive services.
    (2) Require that IHCPs, whether participating or not, be paid for 
covered services provided to Indian enrollees who are eligible to 
receive services from such providers as follows:
    (i) At a rate negotiated between the MCO, PIHP, PAHP, or PCCM 
entity, and the IHCP, or
    (ii) In the absence of a negotiated rate, at a rate not less than 
the level and amount of payment that the MCO, PIHP, PAHP, or PCCM 
entity would make for the services to a participating provider which is 
not an IHCP; and
    (iii) Make payment to all IHCPs in its network in a timely manner 
as required for payments to practitioners in individual or group 
practices under 42 CFR 447.45 and 447.46.
    (3) Permit any Indian who is enrolled in a MCO, PIHP, PAHP, PCCM or 
PCCM entity that is not an IMCE and eligible to receive services from a 
IHCP primary care provider participating as a network provider, to 
choose that IHCP as his or her primary care provider, as long as that 
provider has capacity to provide the services.
    (4) Permit Indian enrollees to obtain services covered under the 
contract between the State and the MCO, PIHP, PAHP, or PCCM entity from 
out-of-network IHCPs from whom the enrollee is otherwise eligible to 
receive such services.
    (5) In a State where timely access to covered services cannot be 
ensured due to few or no IHCPs, an MCO, PIHP, PAHP and PCCM entity will 
be considered to have met the requirement in paragraph (b)(1) of this 
section if--
    (i) Indian enrollees are permitted by the MCO, PIHP, PAHP, or PCCM 
entity to access out-of-State IHCPs; or
    (ii) If this circumstance is deemed to be good cause for 
disenrollment from both the MCO, PIHP, PAHP, or PCCM entity and the 
State's managed care program in accordance with Sec.  438.56(c).
    (6) MCOs, PIHPs, PAHPs, and PCCM entities, to the extent the PCCM 
entity has a provider network, must permit an out-of-network IHCP to 
refer an Indian enrollee to a network provider.
    (c) Payment requirements. (1) When an IHCP is enrolled in Medicaid 
as a FQHC but not a participating provider of the MCO, PIHP, PAHP or 
PCCM entity, it must be paid an amount equal to the amount the MCO, 
PIHP, PAHP, or PCCM entity would pay a FQHC that is a network provider 
but is not an IHCP, including any supplemental payment from the State 
to make up the difference between the amount the MCO, PIHP, PAHP or 
PCCM entity pays and what the IHCP FQHC would have received under FFS.
    (2) When an IHCP is not enrolled in Medicaid as a FQHC, regardless 
of whether it participates in the network of an MCO, PIHP, PAHP and 
PCCM entity or not, it has the right to receive its applicable 
encounter rate published annually in the Federal Register by the Indian 
Health Service, or in the absence of a published encounter rate, the 
amount it would receive if the services were provided under the State 
plan's FFS payment methodology.
    (3) When the amount a IHCP receives from a MCO, PIHP, PAHP, or PCCM 
entity is less than the amount required by paragraph (c)(2) of this 
section, the State must make a supplemental payment to the IHCP to make 
up the difference between the amount the MCO, PIHP, PAHP, or PCCM 
entity pays and the amount the IHCP would have received under FFS or 
the applicable encounter rate.
    (d) Enrollment in IMCEs. An IMCE may restrict its enrollment to 
Indians in the same manner as Indian Health Programs, as defined in 25 
U.S.C. 1603(12), may restrict the delivery of services to Indians, 
without being in violation of the requirements in Sec.  438.3(d).

Subpart B--State Responsibilities


Sec.  438.50  State Plan requirements.

    (a) General rule. A State plan that requires Medicaid beneficiaries 
to enroll in MCOs, PCCMs, or PCCM entities must comply with the 
provisions of this section, except when the State imposes the 
requirement--
    (1) As part of a demonstration project under section 1115(a) of the 
Act; or
    (2) Under a waiver granted under section 1915(b) of the Act.
    (b) State plan information. The plan must specify--
    (1) The types of entities with which the State contracts.
    (2) The payment method it uses (for example, whether FFS or 
capitation).
    (3) Whether it contracts on a comprehensive risk basis.
    (4) The process the State uses to involve the public in both design 
and initial implementation of the managed care program and the methods 
it uses to ensure ongoing public involvement once the State plan has 
been implemented.
    (c) State plan assurances. The plan must provide assurances that 
the State meets applicable requirements of the following statute and 
regulations:
    (1) Section 1903(m) of the Act, for MCOs and MCO contracts.
    (2) Section 1905(t) of the Act, for PCCMs and PCCM or PCCM entity 
contracts.
    (3) Section 1932(a)(1)(A) of the Act, for the State's option to 
limit freedom of choice by requiring beneficiaries to receive their 
benefits through managed care entities.
    (4) This part, for MCOs, PCCMs, and PCCM entities.
    (5) Part 434 of this chapter, for all contracts.
    (6) Section 438.4, for payments under any risk contracts, and Sec.  
447.362 of this chapter for payments under any nonrisk contracts.
    (d) Limitations on enrollment. The State must provide assurances 
that, in implementing the State plan managed care option, it will not 
require the following groups to enroll in an MCO, PCCM or PCCM entity:
    (1) Beneficiaries who are also eligible for Medicare.
    (2) Indians as defined in Sec.  438.14(a), except as permitted 
under Sec.  438.14(d).
    (3) Children under 19 years of age who are:
    (i) Eligible for SSI under Title XVI;
    (ii) Eligible under section 1902(e)(3) of the Act;
    (iii) In foster care or other out-of-home placement;
    (iv) Receiving foster care or adoption assistance; or

[[Page 27869]]

    (v) Receiving services through a family-centered, community-based, 
coordinated care system that receives grant funds under section 
501(a)(1)(D) of Title V, and is defined by the State in terms of either 
program participation or special health care needs.


Sec.  438.52  Choice of MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities.

    (a) General rule. Except as specified in paragraphs (b) and (c) of 
this section, a State that requires Medicaid beneficiaries to:
    (1) Enroll in an MCO, PIHP, or PAHP, must give those beneficiaries 
a choice of at least two MCOs, PIHPs, or PAHPs.
    (2) Enroll in a primary care case management system, must give 
those beneficiaries a choice from at least two primary care case 
managers employed or contracted with the State.
    (3) Enroll in a PCCM entity, may limit a beneficiary to a single 
PCCM entity. Beneficiaries must be permitted to choose from at least 
two primary care case managers employed by or contracted with the PCCM 
entity.
    (b) Exception for rural area residents. (1) Under any managed care 
program authorized by any of the following, and subject to the 
requirements of paragraph (b)(2) of this section, a State may limit a 
rural area resident to a single MCO, PIHP, or PAHP:
    (i) A State plan amendment under section 1932(a) of the Act.
    (ii) A waiver under section 1115(a) of the Act.
    (iii) A waiver under section 1915(b) of the Act.
    (2) To comply with this paragraph (b), a State, must permit the 
beneficiary--
    (i) To choose from at least two primary care providers; and
    (ii) To obtain services from any other provider under any of the 
following circumstances:
    (A) The service or type of provider (in terms of training, 
experience, and specialization) is not available within the MCO, PIHP, 
or PAHP network.
    (B) The provider is not part of the network, but is the main source 
of a service to the beneficiary, provided that--
    (1) The provider is given the opportunity to become a participating 
provider under the same requirements for participation in the MCO, 
PIHP, or PAHP network as other network providers of that type.
    (2) If the provider chooses not to join the network, or does not 
meet the necessary qualification requirements to join, the enrollee 
will be transitioned to a participating provider within 60 calendar 
days (after being given an opportunity to select a provider who 
participates).
    (C) The only plan or provider available to the beneficiary does 
not, because of moral or religious objections, provide the service the 
enrollee seeks.
    (D) The beneficiary's primary care provider or other provider 
determines that the beneficiary needs related services that would 
subject the beneficiary to unnecessary risk if received separately (for 
example, a cesarean section and a tubal ligation) and not all of the 
related services are available within the network.
    (E) The State determines that other circumstances warrant out-of-
network treatment.
    (3) As used in this paragraph (b), ``rural area'' is any county 
designated as ``micro,'' ``rural,'' or ``County with Extreme Access 
Considerations (CEAC)'' in the Medicare Advantage Health Services 
Delivery (HSD) Reference file for the applicable calendar year.
    (c) Exception for certain health insuring organizations (HIOs). The 
State may limit beneficiaries to a single HIO if--
    (1) The HIO is one of those described in section 1932(a)(3)(C) of 
the Act; and
    (2) The beneficiary who enrolls in the HIO has a choice of at least 
two primary care providers within the entity.
    (d) Limitations on changes between primary care providers. For an 
enrollee of a single MCO, PIHP, PAHP, or HIO under paragraph (b) or (c) 
of this section, any limitation the State imposes on his or her freedom 
to change between primary care providers may be no more restrictive 
than the limitations on disenrollment under Sec.  438.56(c).


Sec.  438.54  Managed care enrollment.

    (a) Applicability. The provisions of this section apply to all 
Medicaid managed care programs which operate under any authority in the 
Act.
    (b) General rule. The State must have an enrollment system for its 
managed care programs, voluntary and mandatory, as appropriate.
    (1) Voluntary managed care programs are those where one or more 
groups of beneficiaries as enumerated in section of 1905(a) of the Act 
have the option to either enroll in a MCO, PIHP, PAHP, PCCM or PCCM 
entity, or remain enrolled in FFS to receive Medicaid covered benefits.
    (2) Mandatory managed care programs are those where one or more 
groups of beneficiaries as enumerated in section 1905(a) of the Act 
must enroll in a MCO, PIHP, PAHP, PCCM or PCCM entity to receive 
covered Medicaid benefits.
    (c) Voluntary managed care programs. (1) States that have a 
voluntary managed care program must have an enrollment system that:
    (i) Provides an enrollment choice period during which potential 
enrollees may make an active choice of delivery system and, if needed, 
choice of an MCO, PIHP, PAHP, PCCM or PCCM entity before enrollment is 
effectuated; or
    (ii) Employs a passive enrollment process in which the State 
enrolls the potential enrollee into a MCO, PIHP, PAHP, PCCM or PCCM 
entity and simultaneously provides a period of time for the enrollee to 
make an active choice of delivery system and, if needed, to maintain 
enrollment in the MCO, PIHP, PAHP, PCCM or PCCM entity passively 
assigned or to select a different MCO, PIHP, PAHP, PCCM or PCCM entity.
    (2) A State must provide potential enrollees the opportunity to 
actively elect to receive covered services through the managed care or 
FFS delivery system. If the potential enrollee elects to receive 
covered services through the managed care delivery system, the 
potential enrollee must then also select a MCO, PIHP, PAHP, PCCM, or 
PCCM entity.
    (i) If the State does not use a passive enrollment process and the 
potential enrollee does not make an active choice during the period 
allowed by the state, then the potential enrollee will continue to 
receive covered services through the FFS delivery system.
    (ii) If the State uses a passive enrollment process, the potential 
enrollee must select either to accept the MCO, PIHP, PAHP, PCCM, or 
PCCM entity selected for them by the State's passive enrollment 
process, select a different MCO, PIHP, PAHP, PCCM, or PCCM entity, or 
elect to receive covered services through the FFS delivery system. If 
the potential enrollee does not make an active choice during the time 
allowed by the state, the potential enrollee will remain enrolled with 
the MCO, PIHP, PAHP, PCCM, or PCCM entity selected by the passive 
enrollment process.
    (3) The State must provide informational notices to each potential 
enrollee at the time the potential enrollee first becomes eligible to 
enroll in a managed care program and within a timeframe that enables 
the potential enrollee to use the information in choosing among 
available delivery system and/or managed care plan options. The notices 
must:
    (i) Clearly explain (as relevant to the State's managed care 
program) the implications to the potential enrollee of: not making an 
active choice between managed care and FFS; selecting a different MCO, 
PIHP, PAHP, PCCM or PCCM entity; and accepting the MCO,

[[Page 27870]]

PIHP, PAHP, PCCM, or PCCM entity selected by the State;
    (ii) Identify the MCOs, PIHPs, PAHPs, PCCMs or PCCM entities 
available to the potential enrollee should they elect the managed care 
delivery system;
    (iii) Provide clear instructions for how to make known to the State 
the enrollee's selection of the FFS delivery system or a MCO, PIHP, 
PAHP, PCCM or PCCM entity;
    (iv) Provide a comprehensive explanation of the length of the 
enrollment period, the 90 day without cause disenrollment period, and 
all other disenrollment options as specified in Sec.  438.56;
    (v) Include the contact information for the beneficiary support 
system in Sec.  438.71; and
    (vi) Comply with the information requirements in Sec.  438.10.
    (4) The State's enrollment system must provide that beneficiaries 
already enrolled in an MCO, PIHP, PAHP, PCCM or PCCM entity are given 
priority to continue that enrollment if the MCO, PIHP, PAHP, PCCM or 
PCCM entity does not have the capacity to accept all those seeking 
enrollment under the program.
    (5) If a State elects to use a passive enrollment process, the 
process must assign beneficiaries to a qualified MCO, PIHP, PAHP, PCCM 
or PCCM entity. To be a qualified MCO, PIHP, PAHP, PCCM or PCCM entity, 
it must:
    (i) Not be subject to the intermediate sanction described in Sec.  
438.702(a)(4); and
    (ii) Have capacity to enroll beneficiaries.
    (6) A passive enrollment process must seek to preserve existing 
provider-beneficiary relationships and relationships with providers 
that have traditionally served Medicaid beneficiaries.
    (i) An ``existing provider-beneficiary relationship'' is one in 
which the provider was a main source of Medicaid services for the 
beneficiary during the previous year. This may be established through 
State records of previous managed care enrollment or FFS experience, 
encounter data, or through contact with the beneficiary.
    (ii) A provider is considered to have ``traditionally served'' 
Medicaid beneficiaries if it has experience in serving the Medicaid 
population.
    (7) If the approach in paragraph (c)(6) of this section is not 
possible, the State must distribute the beneficiaries equitably among 
the MCOs, PIHPs, PAHPs, PCCMs and PCCM entities.
    (i) The State may not arbitrarily exclude any MCO, PIHP, PAHP, 
PCCM, or PCCM entity from being considered.
    (ii) The State may consider additional criteria to conduct the 
passive enrollment process, including the enrollment preferences of 
family members, previous plan assignment of the beneficiary, quality 
assurance and improvement performance, procurement evaluation elements, 
accessibility of provider offices for people with disabilities (when 
appropriate), and other reasonable criteria that support the objectives 
of the managed care program.
    (8) If a passive enrollment process is used and the enrollee does 
not elect to be enrolled into the FFS delivery system, the State must 
send a notice to the enrollee:
    (i) Confirming that the enrollee's time to elect to enroll in the 
FFS delivery system has ended and that the enrollee will remain 
enrolled in the managed care delivery system for the remainder of the 
enrollment period unless one of the disenrollment reasons specified in 
Sec.  438.56 applies.
    (ii) Clearly and fully explaining the enrollee's right, and process 
to follow, to disenroll from the passively assigned MCO, PIHP, PAHP, 
PCCM or PCCM entity and select a different MCO, PIHP, PAHP, PCCM or 
PCCM entity within 90 days from the effective date of the enrollment or 
for any reason specified in Sec.  438.56(d)(2).
    (iii) Within 5 calendar days of the end of the time allowed for 
making the delivery system selection.
    (d) Mandatory managed care programs. (1) States must have an 
enrollment system for a mandatory managed care program that includes 
the elements specified in paragraphs (d)(2) through (8) of this 
section.
    (2) The State's enrollment system must implement enrollment in a 
MCO, PIHP, PAHP, PCCM, or PCCM entity as follows:
    (i) If the State does not use a passive enrollment process and the 
potential enrollee does not make an active choice of a MCO, PIHP, PAHP, 
PCCM, or PCCM entity during the period allowed by the State, the 
potential enrollee will be enrolled into a MCO, PIHP, PAHP, PCCM, or 
PCCM entity selected by the State's default process.
    (ii) If the State uses a passive enrollment process, the potential 
enrollee must either accept the MCO, PIHP, PAHP, PCCM, or PCCM entity 
selected by the State's passive enrollment process or select a 
different MCO, PIHP, PAHP, PCCM, or PCCM entity. If the potential 
enrollee does not make an active choice during the time allowed by the 
State, the MCO, PIHP, PAHP, PCCM, or PCCM entity selected by the 
passive enrollment process will remain effective.
    (3) A State must provide informational notices to each potential 
enrollee at the time the potential enrollee first becomes eligible to 
enroll in a managed care program and within a timeframe that enables 
the potential enrollee to use the information in choosing among 
available managed care plans. The notices must:
    (i) Include the MCOs, PIHPs, PAHPs, PCCMs, or PCCM entities 
available to the potential enrollee;
    (ii) Provide clear instructions for how to make known to the State 
the enrollee's selection of a MCO, PIHP, PAHP, PCCM, or PCCM entity;
    (iii) Clearly explain the implications to the potential enrollee of 
not making an active choice of an MCO, PIHP, PAHP, PCCM or PCCM entity 
as well as the implications of making an active choice of an MCO, PIHP, 
PAHP, PCCM or PCCM entity;
    (iv) Provide a comprehensive explanation of the length of the 
enrollment period, the 90 day without cause disenrollment period, and 
all other disenrollment options as specified in Sec.  438.56;
    (v) Include the contact information for the beneficiary support 
system in Sec.  438.71; and
    (vi) Comply with the information requirements in Sec.  438.10.
    (4) Priority for enrollment. The State's enrollment system must 
provide that beneficiaries already enrolled in an MCO, PIHP, PAHP, PCCM 
or PCCM entity are given priority to continue that enrollment if the 
MCO, PIHP, PAHP, PCCM or PCCM entity does not have the capacity to 
accept all those seeking enrollment under the program.
    (5) Enrollment by default. For potential enrollees that do not 
select an MCO, PIHP, PAHP, PCCM or PCCM entities during the period 
allowed by the state, the State must have a default enrollment process 
for assigning those beneficiaries to qualified MCOs, PIHPs, PAHPs, 
PCCMs and PCCM entities. To be a qualified MCO, PIHP, PAHP, PCCM or 
PCCM entity, it must:
    (i) Not be subject to the intermediate sanction described in Sec.  
438.702(a)(4); and
    (ii) Have capacity to enroll beneficiaries.
    (6) Passive enrollment. For States that use a passive enrollment 
process, the process must assign potential enrollees to qualified MCOs, 
PIHPs, PAHPs, PCCMs and PCCM entities. To be a qualified MCO, PIHP, 
PAHP, PCCM or PCCM entity, it must:

[[Page 27871]]

    (i) Not be subject to the intermediate sanction described in Sec.  
438.702(a)(4); and
    (ii) Have capacity to enroll beneficiaries.
    (7) The passive and default enrollment processes must seek to 
preserve existing provider-beneficiary relationships and relationships 
with providers that have traditionally served Medicaid beneficiaries.
    (i) An ``existing provider-beneficiary relationship'' is one in 
which the provider was a main source of Medicaid services for the 
beneficiary during the previous year. This may be established through 
State records of previous managed care enrollment or FFS experience, 
encounter data, or through contact with the beneficiary.
    (ii) A provider is considered to have ``traditionally served'' 
Medicaid beneficiaries if it has experience in serving the Medicaid 
population.
    (8) If the approach in paragraph (d)(7) of this section is not 
possible, the State must distribute the beneficiaries equitably among 
the MCOs, PIHPs, PAHPs, PCCMs and PCCM entities available to enroll 
them.
    (i) The State may not arbitrarily exclude any MCO, PIHP, PAHP, PCCM 
or PCCM entity from being considered; and
    (ii) The State may consider additional criteria to conduct the 
default enrollment process, including the enrollment preferences of 
family members, previous plan assignment of the beneficiary, quality 
assurance and improvement performance, procurement evaluation elements, 
accessibility of provider offices for people with disabilities (when 
appropriate), and other reasonable criteria related to a beneficiary's 
experience with the Medicaid program.


Sec.  438.56  Disenrollment: Requirements and limitations.

    (a) Applicability. The provisions of this section apply to all 
managed care programs whether enrollment is mandatory or voluntary and 
whether the contract is with an MCO, PIHP, PAHP, PCCM, or PCCM entity.
    (b) Disenrollment requested by the MCO, PIHP, PAHP, PCCM, or PCCM 
entity. All MCO, PIHP, PAHP, PCCM and PCCM entity contracts must:
    (1) Specify the reasons for which the MCO, PIHP, PAHP, PCCM, or 
PCCM entity may request disenrollment of an enrollee.
    (2) Provide that the MCO, PIHP, PAHP, PCCM, or PCCM entity may not 
request disenrollment because of an adverse change in the enrollee's 
health status, or because of the enrollee's utilization of medical 
services, diminished mental capacity, or uncooperative or disruptive 
behavior resulting from his or her special needs (except when his or 
her continued enrollment in the MCO, PIHP, PAHP, PCCM or PCCM entity 
seriously impairs the entity's ability to furnish services to either 
this particular enrollee or other enrollees).
    (3) Specify the methods by which the MCO, PIHP, PAHP, PCCM, or PCCM 
entity assures the agency that it does not request disenrollment for 
reasons other than those permitted under the contract.
    (c) Disenrollment requested by the enrollee. If the State chooses 
to limit disenrollment, its MCO, PIHP, PAHP, PCCM, and PCCM entity 
contracts must provide that a beneficiary may request disenrollment as 
follows:
    (1) For cause, at any time.
    (2) Without cause, at the following times:
    (i) During the 90 days following the date of the beneficiary's 
initial enrollment into the MCO, PIHP, PAHP, PCCM, or PCCM entity, or 
during the 90 days following the date the State sends the beneficiary 
notice of that enrollment, whichever is later.
    (ii) At least once every 12 months thereafter.
    (iii) Upon automatic reenrollment under paragraph (g) of this 
section, if the temporary loss of Medicaid eligibility has caused the 
beneficiary to miss the annual disenrollment opportunity.
    (iv) When the State imposes the intermediate sanction specified in 
Sec.  438.702(a)(4).
    (d) Procedures for disenrollment--(1) Request for disenrollment. 
The beneficiary (or his or her representative) must submit an oral or 
written request, as required by the State--
    (i) To the State (or its agent); or
    (ii) To the MCO, PIHP, PAHP, PCCM, or PCCM entity, if the State 
permits MCOs, PIHP, PAHPs, PCCMs, and PCCM entities to process 
disenrollment requests.
    (2) Cause for disenrollment. The following are cause for 
disenrollment:
    (i) The enrollee moves out of the MCO's, PIHP's, PAHP's, PCCM's, or 
PCCM entity's service area.
    (ii) The plan does not, because of moral or religious objections, 
cover the service the enrollee seeks.
    (iii) The enrollee needs related services (for example, a cesarean 
section and a tubal ligation) to be performed at the same time; not all 
related services are available within the provider network; and the 
enrollee's primary care provider or another provider determines that 
receiving the services separately would subject the enrollee to 
unnecessary risk.
    (iv) For enrollees that use MLTSS, the enrollee would have to 
change their residential, institutional, or employment supports 
provider based on that provider's change in status from an in-network 
to an out-of-network provider with the MCO, PIHP, or PAHP and, as a 
result, would experience a disruption in their residence or employment.
    (v) Other reasons, including poor quality of care, lack of access 
to services covered under the contract, or lack of access to providers 
experienced in dealing with the enrollee's care needs.
    (3) MCO, PIHP, PAHP, PCCM, or PCCM entity action on request. (i) 
When the MCO's, PIHP's, PAHP's, PCCM's, or PCCM entity's contract with 
the State permits the MCO, PIHP, PAHP, PCCM, or PCCM entity to process 
disenrollment requests, the MCO, PIHP, PAHP, PCCM, or PCCM entity may 
either approve a request for disenrollment by or on behalf of an 
enrollee or the MCO, PIHP, PAHP, PCCM, or PCCM entity must refer the 
request to the State.
    (ii) If the MCO, PIHP, PAHP, PCCM, PCCM entity, or State agency 
(whichever is responsible) fails to make a disenrollment determination 
so that the beneficiary can be disenrolled within the timeframes 
specified in paragraph (e)(1) of this section, the disenrollment is 
considered approved.
    (4) State agency action on request. For a request received directly 
from the beneficiary, or one referred by the MCO, PIHP, PAHP, PCCM, or 
PCCM entity, the State agency must take action to approve or disapprove 
the request based on the following:
    (i) Reasons cited in the request.
    (ii) Information provided by the MCO, PIHP, PAHP, PCCM, or PCCM 
entity at the agency's request.
    (iii) Any of the reasons specified in paragraph (d)(2) of this 
section.
    (5) Use of the MCO's, PIHP's, PAHP's, PCCM's, or PCCMs entity's 
grievance procedures. (i) The State agency may require that the 
enrollee seek redress through the MCO's, PIHP's, PAHP's, PCCM's, or 
PCCM entity's grievance system before making a determination on the 
enrollee's request.
    (ii) The grievance process, if used, must be completed in time to 
permit the disenrollment (if approved) to be effective in accordance 
with the timeframe specified in paragraph (e)(1) of this section.
    (iii) If, as a result of the grievance process, the MCO, PIHP, 
PAHP, PCCM, or PCCM entity approves the disenrollment, the State agency 
is not required to make a determination in

[[Page 27872]]

accordance with paragraph (d)(4) of this section.
    (e) Timeframe for disenrollment determinations. (1) Regardless of 
the procedures followed, the effective date of an approved 
disenrollment must be no later than the first day of the second month 
following the month in which the enrollee requests disenrollment or the 
MCO, PIHP, PAHP, PCCM, or PCCM entity refers the request to the State.
    (2) If the MCO, PIHP, PAHP, PCCM, PCCM entity, or the State agency 
(whichever is responsible) fails to make the determination within the 
timeframes specified in paragraph (e)(1) of this section, the 
disenrollment is considered approved for the effective date that would 
have been established had the State or MCO, PIHP, PAHP, PCCM, PCCM 
entity complied with paragraph (e)(1) of this section.
    (f) Notice and appeals. A State that restricts disenrollment under 
this section must take the following actions:
    (1) Provide that enrollees and their representatives are given 
written notice of disenrollment rights at least 60 days before the 
start of each enrollment period. The notice must include an explanation 
of all of the enrollee's disenrollment rights as specified in this 
section.
    (2) Ensure timely access to State fair hearing for any enrollee 
dissatisfied with a State agency determination that there is not good 
cause for disenrollment.
    (g) Automatic reenrollment: Contract requirement. If the State plan 
so specifies, the contract must provide for automatic reenrollment of a 
beneficiary who is disenrolled solely because he or she loses Medicaid 
eligibility for a period of 2 months or less.


Sec.  438.58  Conflict of interest safeguards.

    As a condition for contracting with MCOs, PIHPs, or PAHPs, a State 
must have in effect safeguards against conflict of interest on the part 
of State and local officers and employees and agents of the State who 
have responsibilities relating to the MCO, PIHP, or PAHP contracts or 
the enrollment processes specified in Sec.  438.54(b). These safeguards 
must be at least as effective as the safeguards specified in section 27 
of the Office of Federal Procurement Policy Act (41 U.S.C. 423).


Sec.  438.60  Prohibition of additional payments for services covered 
under MCO, PIHP or PAHP contracts.

    The State agency must ensure that no payment is made to a network 
provider other than by the MCO, PIHP, or PAHP for services covered 
under the contract between the State and the MCO, PIHP, or PAHP, except 
when these payments are specifically required to be made by the State 
in Title XIX of the Act, in 42 CFR chapter IV, or when the State agency 
makes direct payments to network providers for graduate medical 
education costs approved under the State plan.


Sec.  438.62  Continued services to enrollees.

    (a) The State agency must arrange for Medicaid services to be 
provided without delay to any Medicaid enrollee of an MCO, PIHP, PAHP, 
PCCM, or PCCM entity the contract of which is terminated and for any 
Medicaid enrollee who is disenrolled from an MCO, PIHP, PAHP, PCCM, or 
PCCM entity for any reason other than ineligibility for Medicaid.
    (b) The State must have in effect a transition of care policy to 
ensure continued access to services during a transition from FFS to a 
MCO, PIHP, PAHP, PCCM or PCCM entity or transition from one MCO, PIHP, 
PAHP, PCCM or PCCM entity to another when an enrollee, in the absence 
of continued services, would suffer serious detriment to their health 
or be at risk of hospitalization or institutionalization.
    (1) The transition of care policy must include the following:
    (i) The enrollee has access to services consistent with the access 
they previously had, and is permitted to retain their current provider 
for a period of time if that provider is not in the MCO, PIHP or PAHP 
network.
    (ii) The enrollee is referred to appropriate providers of services 
that are in the network.
    (iii) The State, in the case of FFS, PCCM, or PCCM entity, or the 
MCO, PIHP or PAHP that was previously serving the enrollee, fully and 
timely complies with requests for historical utilization data from the 
new MCO, PIHP, PAHP, PCCM, or PCCM entity in compliance with Federal 
and State law.
    (iv) Consistent with Federal and State law, the enrollee's new 
provider(s) are able to obtain copies of the enrollee's medical 
records, as appropriate.
    (v) Any other necessary procedures as specified by the Secretary to 
ensure continued access to services to prevent serious detriment to the 
enrollee's health or reduce the risk of hospitalization or 
institutionalization.
    (2) The State must require by contract that MCOs, PIHPs, and PAHPs 
implement a transition of care policy consistent with the requirements 
in paragraph (b)(1) of this section and at least meets the State 
defined transition of care policy.
    (3) The State must make its transition of care policy publicly 
available and provide instructions to enrollees and potential enrollees 
on how to access continued services upon transition. At a minimum, the 
transition of care policy must be described in the quality strategy, 
under Sec.  438.340, and explained to individuals in the materials to 
enrollees and potential enrollees, in accordance with Sec.  438.10.
    (c) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities 
beginning on or after July 1, 2018. Until that applicability date, 
states are required to continue to comply with Sec.  438.62 contained 
in the 42 CFR parts 430 to 481, edition revised as of October 1, 2015.


Sec.  438.66  State monitoring requirements.

    (a) General requirement. The State agency must have in effect a 
monitoring system for all managed care programs.
    (b) The State's system must address all aspects of the managed care 
program, including the performance of each MCO, PIHP, PAHP, and PCCM 
entity (if applicable) in at least the following areas:
    (1) Administration and management.
    (2) Appeal and grievance systems.
    (3) Claims management.
    (4) Enrollee materials and customer services, including the 
activities of the beneficiary support system.
    (5) Finance, including medical loss ratio reporting.
    (6) Information systems, including encounter data reporting.
    (7) Marketing.
    (8) Medical management, including utilization management and case 
management.
    (9) Program integrity.
    (10) Provider network management, including provider directory 
standards.
    (11) Availability and accessibility of services, including network 
adequacy standards.
    (12) Quality improvement.
    (13) Areas related to the delivery of LTSS not otherwise included 
in paragraphs (b)(1) through (12) of this section as applicable to the 
managed care program.
    (14) All other provisions of the contract, as appropriate.
    (c) The State must use data collected from its monitoring 
activities to improve the performance of its managed care program, 
including at a minimum:
    (1) Enrollment and disenrollment trends in each MCO, PIHP, or PAHP.
    (2) Member grievance and appeal logs.
    (3) Provider complaint and appeal logs.
    (4) Findings from the State's External Quality Review process.

[[Page 27873]]

    (5) Results from any enrollee or provider satisfaction survey 
conducted by the State or MCO, PIHP, or PAHP.
    (6) Performance on required quality measures.
    (7) Medical management committee reports and minutes.
    (8) The annual quality improvement plan for each MCO, PIHP, PAHP, 
or PCCM entity.
    (9) Audited financial and encounter data submitted by each MCO, 
PIHP, or PAHP.
    (10) The medical loss ratio summary reports required by Sec.  
438.8.
    (11) Customer service performance data submitted by each MCO, PIHP, 
or PAHP and performance data submitted by the beneficiary support 
system.
    (12) Any other data related to the provision of LTSS not otherwise 
included in paragraphs (c)(1) through (11) of this section as 
applicable to the managed care program.
    (d)(1) The State must assess the readiness of each MCO, PIHP, PAHP 
or PCCM entity with which it contracts as follows:
    (i) Prior to the State implementing a managed care program, whether 
the program is voluntary or mandatory.
    (ii) When the specific MCO, PIHP, PAHP, or PCCM entity has not 
previously contracted with the State.
    (iii) When any MCO, PIHP, PAHP, or PCCM entity currently 
contracting with the State will provide or arrange for the provision of 
covered benefits to new eligibility groups.
    (2) The State must conduct a readiness review of each MCO, PIHP, 
PAHP, or PCCM entity with which it contracts as follows:
    (i) Started at least 3 months prior to the effective date of the 
events described in paragraph (d)(1) of this section.
    (ii) Completed in sufficient time to ensure smooth implementation 
of an event described in paragraph (d)(1) of this section.
    (iii) Submitted to CMS for CMS to make a determination that the 
contract or contract amendment associated with an event described in 
paragraph (d)(1) of this section is approved under Sec.  438.3(a).
    (3) Readiness reviews described in paragraphs (d)(1)(i) and (ii) of 
this section must include both a desk review of documents and on-site 
reviews of each MCO, PIHP, PAHP, or PCCM entity. Readiness reviews 
described in paragraph (d)(1)(iii) of this section must include a desk 
review of documents and may, at the State's option, include an on-site 
review. On-site reviews must include interviews with MCO, PIHP, PAHP, 
or PCCM entity staff and leadership that manage key operational areas.
    (4) A State's readiness review must assess the ability and capacity 
of the MCO, PIHP, PAHP, and PCCM entity (if applicable) to perform 
satisfactorily for the following areas:
    (i) Operations/Administration, including--
    (A) Administrative staffing and resources.
    (B) Delegation and oversight of MCO, PIHP, PAHP or PCCM entity 
responsibilities.
    (C) Enrollee and provider communications.
    (D) Grievance and appeals.
    (E) Member services and outreach.
    (F) Provider Network Management.
    (G) Program Integrity/Compliance.
    (ii) Service delivery, including--
    (A) Case management/care coordination/service planning.
    (B) Quality improvement.
    (C) Utilization review.
    (iii) Financial management, including--
    (A) Financial reporting and monitoring.
    (B) Financial solvency.
    (iv) Systems management, including--
    (A) Claims management.
    (B) Encounter data and enrollment information management.
    (e)(1) The State must submit to CMS no later than 180 days after 
each contract year, a report on each managed care program administered 
by the State, regardless of the authority under which the program 
operates.
    (i) The initial report will be due after the contract year 
following the release of CMS guidance on the content and form of the 
report.
    (ii) For States that operate their managed care program under 
section 1115(a) of the Act authority, submission of an annual report 
that may be required by the Special Terms and Conditions of the section 
1115(a) demonstration program will be deemed to satisfy the requirement 
of this paragraph (e)(1) provided that the report includes the 
information specified in paragraph (e)(2) of this section.
    (2) The program report must provide information on and an 
assessment of the operation of the managed care program on, at a 
minimum, the following areas:
    (i) Financial performance of each MCO, PIHP, and PAHP, including 
MLR experience.
    (ii) Encounter data reporting by each MCO, PIHP, or PAHP.
    (iii) Enrollment and service area expansion (if applicable) of each 
MCO, PIHP, PAHP, and PCCM entity.
    (iv) Modifications to, and implementation of, MCO, PIHP, or PAHP 
benefits covered under the contract with the State.
    (v) Grievance, appeals, and State fair hearings for the managed 
care program.
    (vi) Availability and accessibility of covered services within the 
MCO, PIHP, or PAHP contracts, including network adequacy standards.
    (vii) Evaluation of MCO, PIHP, or PAHP performance on quality 
measures, including as applicable, consumer report card, surveys, or 
other reasonable measures of performance.
    (viii) Results of any sanctions or corrective action plans imposed 
by the State or other formal or informal intervention with a contracted 
MCO, PIHP, PAHP, or PCCM entity to improve performance.
    (ix) Activities and performance of the beneficiary support system.
    (x) Any other factors in the delivery of LTSS not otherwise 
addressed in (e)(2)(i)-(ix) of this section as applicable.
    (3) The program report required in this section must be:
    (i) Posted on the Web site required under Sec.  438.10(c)(3).
    (ii) Provided to the Medical Care Advisory Committee, required 
under Sec.  431.12 of this chapter.
    (iii) Provided to the stakeholder consultation group specified in 
Sec.  438.70, to the extent that the managed care program includes 
LTSS.
    (f) Applicability. States will not be held out of compliance with 
the requirements of paragraphs (a) through (d) of this section prior to 
the rating period for contracts starting on or after July 1, 2017, so 
long as they comply with the corresponding standard(s) codified in 42 
CFR 438.66 contained in the 42 CFR, parts 430 to 481, edition revised 
as of October 1, 2015.


Sec.  438.68  Network adequacy standards.

    (a) General rule. A State that contracts with an MCO, PIHP or PAHP 
to deliver Medicaid services must develop and enforce network adequacy 
standards consistent with this section.
    (b) Provider-specific network adequacy standards. (1) At a minimum, 
a State must develop time and distance standards for the following 
provider types, if covered under the contract:
    (i) Primary care, adult and pediatric.
    (ii) OB/GYN.
    (iii) Behavioral health (mental health and substance use disorder), 
adult and pediatric.
    (iv) Specialist, adult and pediatric.
    (v) Hospital.
    (vi) Pharmacy.
    (vii) Pediatric dental.
    (viii) Additional provider types when it promotes the objectives of 
the Medicaid program, as determined by CMS, for the provider type to be 
subject to time and distance access standards.

[[Page 27874]]

    (2) LTSS. States with MCO, PIHP or PAHP contracts which cover LTSS 
must develop:
    (i) Time and distance standards for LTSS provider types in which an 
enrollee must travel to the provider to receive services; and
    (ii) Network adequacy standards other than time and distance 
standards for LTSS provider types that travel to the enrollee to 
deliver services.
    (3) Scope of network adequacy standards. Network standards 
established in accordance with paragraphs (b)(1) and (2) of this 
section must include all geographic areas covered by the managed care 
program or, if applicable, the contract between the State and the MCO, 
PIHP or PAHP. States are permitted to have varying standards for the 
same provider type based on geographic areas.
    (c) Development of network adequacy standards. (1) States 
developing network adequacy standards consistent with paragraph (b)(1) 
of this section must consider, at a minimum, the following elements:
    (i) The anticipated Medicaid enrollment.
    (ii) The expected utilization of services.
    (iii) The characteristics and health care needs of specific 
Medicaid populations covered in the MCO, PIHP, and PAHP contract.
    (iv) The numbers and types (in terms of training, experience, and 
specialization) of network providers required to furnish the contracted 
Medicaid services.
    (v) The numbers of network providers who are not accepting new 
Medicaid patients.
    (vi) The geographic location of network providers and Medicaid 
enrollees, considering distance, travel time, the means of 
transportation ordinarily used by Medicaid enrollees.
    (vii) The ability of network providers to communicate with limited 
English proficient enrollees in their preferred language.
    (viii) The ability of network providers to ensure physical access, 
reasonable accommodations, culturally competent communications, and 
accessible equipment for Medicaid enrollees with physical or mental 
disabilities.
    (ix) The availability of triage lines or screening systems, as well 
as the use of telemedicine, e-visits, and/or other evolving and 
innovative technological solutions.
    (2) States developing standards consistent with paragraph (b)(2) of 
this section must consider the following:
    (i) All elements in paragraphs (c)(1)(i) through (ix) of this 
section.
    (ii) Elements that would support an enrollee's choice of provider.
    (iii) Strategies that would ensure the health and welfare of the 
enrollee and support community integration of the enrollee.
    (iv) Other considerations that are in the best interest of the 
enrollees that need LTSS.
    (d) Exceptions process. (1) To the extent the State permits an 
exception to any of the provider-specific network standards developed 
under this section, the standard by which the exception will be 
evaluated and approved must be:
    (i) Specified in the MCO, PIHP or PAHP contract.
    (ii) Based, at a minimum, on the number of providers in that 
specialty practicing in the MCO, PIHP, or PAHP service area.
    (2) States that grant an exception in accordance with paragraph 
(d)(1) of this section to a MCO, PIHP or PAHP must monitor enrollee 
access to that provider type on an ongoing basis and include the 
findings to CMS in the managed care program assessment report required 
under Sec.  438.66.
    (e) Publication of network adequacy standards. States must publish 
the standards developed in accordance with paragraphs (b)(1) and (2) of 
this section on the Web site required by Sec.  438.10. Upon request, 
network adequacy standards must also be made available at no cost to 
enrollees with disabilities in alternate formats or through the 
provision of auxiliary aids and services.


Sec.  438.70  Stakeholder engagement when LTSS is delivered through a 
managed care program.

    The State must ensure the views of beneficiaries, individuals 
representing beneficiaries, providers, and other stakeholders are 
solicited and addressed during the design, implementation, and 
oversight of a State's managed LTSS program. The composition of the 
stakeholder group and frequency of meetings must be sufficient to 
ensure meaningful stakeholder engagement.


Sec.  438.71  Beneficiary support system.

    (a) General requirement. The State must develop and implement a 
beneficiary support system that provides support to beneficiaries both 
prior to and after enrollment in a MCO, PIHP, PAHP, PCCM or PCCM 
entity.
    (b) Elements of the support system. (1) A State beneficiary support 
system must include at a minimum:
    (i) Choice counseling for all beneficiaries.
    (ii) Assistance for enrollees in understanding managed care.
    (iii) Assistance as specified for enrollees who use, or express a 
desire to receive, LTSS in paragraph (d) of this section.
    (2) The beneficiary support system must perform outreach to 
beneficiaries and/or authorized representatives and be accessible in 
multiple ways including phone, Internet, in-person, and via auxiliary 
aids and services when requested.
    (c) Choice counseling. (1) Choice counseling, as defined in Sec.  
438.2, must be provided to all potential enrollees and enrollees who 
disenroll from a MCO, PIHP, PAHP, PCCM or PCCM entity for reasons 
specified in Sec.  438.56(b) and (c).
    (2) If an individual or entity provides choice counseling on the 
State's behalf under a memorandum of agreement or contract, it is 
considered an enrollment broker as defined in Sec.  438.810(a) and must 
meet the independence and freedom from conflict of interest standards 
in Sec.  438.810(b)(1) and (2).
    (3) An entity that receives non-Medicaid funding to represent 
beneficiaries at hearings may provide choice counseling on behalf of 
the State so long as the State requires firewalls to ensure that the 
requirements for the provision of choice counseling are met.
    (d) Functions specific to LTSS activities. At a minimum, the 
beneficiary support system must provide the following support to 
enrollees who use, or express a desire to receive, LTSS:
    (1) An access point for complaints and concerns about MCO, PIHP, 
PAHP, PCCM, and PCCM entity enrollment, access to covered services, and 
other related matters.
    (2) Education on enrollees' grievance and appeal rights within the 
MCO, PIHP or PAHP; the State fair hearing process; enrollee rights and 
responsibilities; and additional resources outside of the MCO, PIHP or 
PAHP.
    (3) Assistance, upon request, in navigating the grievance and 
appeal process within the MCO, PIHP or PAHP, as well as appealing 
adverse benefit determinations by the MCO, PIHP, or PAHP to a State 
fair hearing. The system may not provide representation to the enrollee 
at a State fair hearing but may refer enrollees to sources of legal 
representation.
    (4) Review and oversight of LTSS program data to provide guidance 
to the State Medicaid Agency on identification, remediation and 
resolution of systemic issues.


Sec.  438.74  State oversight of the minimum MLR requirement.

    (a) State reporting requirement. (1) The State must annually submit 
to CMS a summary description of the report(s)

[[Page 27875]]

received from the MCO(s), PIHP(s), and PAHP(s) under contract with the 
State, according to Sec.  438.8(k), with the rate certification 
required in Sec.  438.7.
    (2) The summary description must include, at a minimum, the amount 
of the numerator, the amount of the denominator, the MLR percentage 
achieved, the number of member months, and any remittances owed by each 
MCO, PIHP, or PAHP for that MLR reporting year.
    (b) Repayment of Federal share of remittances. (1) If a State 
requires a MCO, PIHP, or PAHP to pay remittances through the contract 
for not meeting the minimum MLR required by the State, the State must 
reimburse CMS for an amount equal to the Federal share of the 
remittance, taking into account applicable differences in the Federal 
matching rate.
    (2) If a remittance is owed according to paragraph (b)(1) of this 
section, the State must submit a separate report describing the 
methodology used to determine the State and Federal share of the 
remittance with the report required in paragraph (a) of this section.

Subpart C--Enrollee Rights and Protections


Sec.  438.100  Enrollee rights.

    (a) General rule. The State must ensure that:
    (1) Each MCO, PIHP, PAHP, PCCM and PCCM entity has written policies 
regarding the enrollee rights specified in this section; and
    (2) Each MCO, PIHP, PAHP, PCCM and PCCM entity complies with any 
applicable Federal and State laws that pertain to enrollee rights, and 
ensures that its employees and contracted providers observe and protect 
those rights.
    (b) Specific rights--(1) Basic requirement. The State must ensure 
that each managed care enrollee is guaranteed the rights as specified 
in paragraphs (b)(2) and (3) of this section.
    (2) An enrollee of an MCO, PIHP, PAHP, PCCM, or PCCM entity has the 
following rights: The right to--
    (i) Receive information in accordance with Sec.  438.10.
    (ii) Be treated with respect and with due consideration for his or 
her dignity and privacy.
    (iii) Receive information on available treatment options and 
alternatives, presented in a manner appropriate to the enrollee's 
condition and ability to understand. (The information requirements for 
services that are not covered under the contract because of moral or 
religious objections are set forth in Sec.  438.10(g)(2)(ii)(A) and 
(B).)
    (iv) Participate in decisions regarding his or her health care, 
including the right to refuse treatment.
    (v) Be free from any form of restraint or seclusion used as a means 
of coercion, discipline, convenience or retaliation, as specified in 
other Federal regulations on the use of restraints and seclusion.
    (vi) If the privacy rule, as set forth in 45 CFR parts 160 and 164 
subparts A and E, applies, request and receive a copy of his or her 
medical records, and request that they be amended or corrected, as 
specified in 45 CFR 164.524 and 164.526.
    (3) An enrollee of an MCO, PIHP, or PAHP (consistent with the scope 
of the PAHP's contracted services) has the right to be furnished health 
care services in accordance with Sec. Sec.  438.206 through 438.210.
    (c) Free exercise of rights. The State must ensure that each 
enrollee is free to exercise his or her rights, and that the exercise 
of those rights does not adversely affect the way the MCO, PIHP, PAHP, 
PCCM or PCCM entity and its network providers or the State agency treat 
the enrollee.
    (d) Compliance with other Federal and State laws. The State must 
ensure that each MCO, PIHP, PAHP, PCCM and PCCM entity complies with 
any other applicable Federal and State laws (including: Title VI of the 
Civil Rights Act of 1964 as implemented by regulations at 45 CFR part 
80; the Age Discrimination Act of 1975 as implemented by regulations at 
45 CFR part 91; the Rehabilitation Act of 1973; Title IX of the 
Education Amendments of 1972 (regarding education programs and 
activities); Titles II and III of the Americans with Disabilities Act; 
and section 1557 of the Patient Protection and Affordable Care Act.


Sec.  438.102  Provider-enrollee communications.

    (a) General rules. (1) An MCO, PIHP, or PAHP may not prohibit, or 
otherwise restrict, a provider acting within the lawful scope of 
practice, from advising or advocating on behalf of an enrollee who is 
his or her patient, for the following:
    (i) The enrollee's health status, medical care, or treatment 
options, including any alternative treatment that may be self-
administered.
    (ii) Any information the enrollee needs to decide among all 
relevant treatment options.
    (iii) The risks, benefits, and consequences of treatment or non-
treatment.
    (iv) The enrollee's right to participate in decisions regarding his 
or her health care, including the right to refuse treatment, and to 
express preferences about future treatment decisions.
    (2) Subject to the information requirements of paragraph (b) of 
this section, an MCO, PIHP, or PAHP that would otherwise be required to 
provide, reimburse for, or provide coverage of, a counseling or 
referral service because of the requirement in paragraph (a)(1) of this 
section is not required to do so if the MCO, PIHP, or PAHP objects to 
the service on moral or religious grounds.
    (b) Information requirements: MCO, PIHP, and PAHP responsibility. 
(1)(i) An MCO, PIHP, or PAHP that elects the option provided in 
paragraph (a)(2) of this section must furnish information about the 
services it does not cover as follows:
    (A) To the State--
    (1) With its application for a Medicaid contract.
    (2) Whenever it adopts the policy during the term of the contract.
    (B) Consistent with the provisions of Sec.  438.10, to enrollees, 
within 90 days after adopting the policy for any particular service.
    (ii) Although this timeframe would be sufficient to entitle the 
MCO, PIHP, or PAHP to the option provided in paragraph (a)(2) of this 
section, the overriding rule in Sec.  438.10(g)(4) requires the State, 
its contracted representative, or MCO, PIHP, or PAHP to furnish the 
information at least 30 days before the effective date of the policy.
    (2) As specified in Sec.  438.10(g)(2)(ii)(A) and (B), the MCOs, 
PIHPs, and PAHPs must inform enrollees how they can obtain information 
from the State about how to access the service excluded under paragraph 
(a)(2) of this section.
    (c) Information requirements: State responsibility. For each 
service excluded by an MCO, PIHP, or PAHP under paragraph (a)(2) of 
this section, the State must provide information on how and where to 
obtain the service, as specified in Sec.  438.10.
    (d) Sanction. An MCO that violates the prohibition of paragraph 
(a)(1) of this section is subject to intermediate sanctions under 
subpart I of this part.


Sec.  438.104  Marketing activities.

    (a) Definitions. As used in this section, the following terms have 
the indicated meanings:
    Cold-call marketing means any unsolicited personal contact by the 
MCO, PIHP, PAHP, PCCM or PCCM entity with a potential enrollee for the 
purpose of marketing as defined in this paragraph (a).
    Marketing means any communication, from an MCO, PIHP, PAHP, PCCM or 
PCCM entity to a Medicaid beneficiary

[[Page 27876]]

who is not enrolled in that entity, that can reasonably be interpreted 
as intended to influence the beneficiary to enroll in that particular 
MCO's, PIHP's, PAHP's, PCCM's or PCCM entity's Medicaid product, or 
either to not enroll in or to disenroll from another MCO's, PIHP's, 
PAHP's, PCCM's or PCCM entity's Medicaid product. Marketing does not 
include communication to a Medicaid beneficiary from the issuer of a 
qualified health plan, as defined in 45 CFR 155.20, about the qualified 
health plan.
    Marketing materials means materials that--
    (i) Are produced in any medium, by or on behalf of an MCO, PIHP, 
PAHP, PCCM, or PCCM entity; and
    (ii) Can reasonably be interpreted as intended to market the MCO, 
PIHP, PAHP, PCCM, or PCCM entity to potential enrollees.
    MCO, PIHP, PAHP, PCCM or PCCM entity include any of the entity's 
employees, network providers, agents, or contractors.
    Private insurance does not include a qualified health plan, as 
defined in 45 CFR 155.20.
    (b) Contract requirements. Each contract with an MCO, PIHP, PAHP, 
PCCM, or PCCM entity must comply with the following requirements:
    (1) Provide that the entity--
    (i) Does not distribute any marketing materials without first 
obtaining State approval.
    (ii) Distributes the materials to its entire service area as 
indicated in the contract.
    (iii) Complies with the information requirements of Sec.  438.10 to 
ensure that, before enrolling, the beneficiary receives, from the 
entity or the State, the accurate oral and written information he or 
she needs to make an informed decision on whether to enroll.
    (iv) Does not seek to influence enrollment in conjunction with the 
sale or offering of any private insurance.
    (v) Does not, directly or indirectly, engage in door-to-door, 
telephone, email, texting, or other cold-call marketing activities.
    (2) Specify the methods by which the entity ensures the State 
agency that marketing, including plans and materials, is accurate and 
does not mislead, confuse, or defraud the beneficiaries or the State 
agency. Statements that will be considered inaccurate, false, or 
misleading include, but are not limited to, any assertion or statement 
(whether written or oral) that--
    (i) The beneficiary must enroll in the MCO, PIHP, PAHP, PCCM or 
PCCM entity to obtain benefits or to not lose benefits; or
    (ii) The MCO, PIHP, PAHP, PCCM or PCCM entity is endorsed by CMS, 
the Federal or State government, or similar entity.
    (c) State agency review. In reviewing the marketing materials 
submitted by the entity, the State must consult with the Medical Care 
Advisory Committee established under Sec.  431.12 of this chapter or an 
advisory committee with similar membership.


Sec.  438.106  Liability for payment.

    Each MCO, PIHP, and PAHP must provide that its Medicaid enrollees 
are not held liable for any of the following:
    (a) The MCO's, PIHP's, or PAHP's debts, in the event of the 
entity's insolvency.
    (b) Covered services provided to the enrollee, for which--
    (1) The State does not pay the MCO, PIHP, or PAHP; or
    (2) The State, or the MCO, PIHP, or PAHP does not pay the 
individual or health care provider that furnished the services under a 
contractual, referral, or other arrangement.
    (c) Payments for covered services furnished under a contract, 
referral, or other arrangement, to the extent that those payments are 
in excess of the amount that the enrollee would owe if the MCO, PIHP, 
or PAHP covered the services directly.


Sec.  438.108  Cost sharing.

    The contract must provide that any cost sharing imposed on Medicaid 
enrollees is in accordance with Sec. Sec.  447.50 through 447.82 of 
this chapter.


Sec.  438.110  Member advisory committee.

    (a) General rule. When LTSS are covered under a risk contract 
between a State and an MCO, PIHP, or PAHP, the contract must provide 
that each MCO, PIHP or PAHP establish and maintain a member advisory 
committee.
    (b) Committee composition. The committee required in paragraph (a) 
of this section must include at least a reasonably representative 
sample of the LTSS populations, or other individuals representing those 
enrollees, covered under the contract with the MCO, PIHP, or PAHP.


Sec.  438.114  Emergency and poststabilization services.

    (a) Definitions. As used in this section--
    Emergency medical condition means a medical condition manifesting 
itself by acute symptoms of sufficient severity (including severe pain) 
that a prudent layperson, who possesses an average knowledge of health 
and medicine, could reasonably expect the absence of immediate medical 
attention to result in the following:
    (i) Placing the health of the individual (or, for a pregnant woman, 
the health of the woman or her unborn child) in serious jeopardy.
    (ii) Serious impairment to bodily functions.
    (iii) Serious dysfunction of any bodily organ or part.
    Emergency services means covered inpatient and outpatient services 
that are as follows:
    (i) Furnished by a provider that is qualified to furnish these 
services under this Title.
    (ii) Needed to evaluate or stabilize an emergency medical 
condition.
    Poststabilization care services means covered services, related to 
an emergency medical condition that are provided after an enrollee is 
stabilized to maintain the stabilized condition, or, under the 
circumstances described in paragraph (e) of this section, to improve or 
resolve the enrollee's condition.
    (b) Coverage and payment: General rule. The following entities are 
responsible for coverage and payment of emergency services and 
poststabilization care services.
    (1) The MCO, PIHP, or PAHP.
    (2) The State, for managed care programs that contract with PCCMs 
or PCCM entities
    (c) Coverage and payment: Emergency services. (1) The entities 
identified in paragraph (b) of this section--
    (i) Must cover and pay for emergency services regardless of whether 
the provider that furnishes the services has a contract with the MCO, 
PIHP, PAHP, PCCM or PCCM entity; and
    (ii) May not deny payment for treatment obtained under either of 
the following circumstances:
    (A) An enrollee had an emergency medical condition, including cases 
in which the absence of immediate medical attention would not have had 
the outcomes specified in paragraphs (1), (2), and (3) of the 
definition of emergency medical condition in paragraph (a) of this 
section.
    (B) A representative of the MCO, PIHP, PAHP, PCCM, or PCCM entity 
instructs the enrollee to seek emergency services.
    (2) A PCCM or PCCM entity must allow enrollees to obtain emergency 
services outside the primary care case management system regardless of 
whether the case manager referred the enrollee to the provider that 
furnishes the services.
    (d) Additional rules for emergency services. (1) The entities 
specified in paragraph (b) of this section may not--

[[Page 27877]]

    (i) Limit what constitutes an emergency medical condition with 
reference to paragraph (a) of this section, on the basis of lists of 
diagnoses or symptoms; and
    (ii) Refuse to cover emergency services based on the emergency room 
provider, hospital, or fiscal agent not notifying the enrollee's 
primary care provider, MCO, PIHP, PAHP or applicable State entity of 
the enrollee's screening and treatment within 10 calendar days of 
presentation for emergency services.
    (2) An enrollee who has an emergency medical condition may not be 
held liable for payment of subsequent screening and treatment needed to 
diagnose the specific condition or stabilize the patient.
    (3) The attending emergency physician, or the provider actually 
treating the enrollee, is responsible for determining when the enrollee 
is sufficiently stabilized for transfer or discharge, and that 
determination is binding on the entities identified in paragraph (b) of 
this section as responsible for coverage and payment.
    (e) Coverage and payment: Poststabilization care services. 
Poststabilization care services are covered and paid for in accordance 
with provisions set forth at Sec.  422.113(c) of this chapter. In 
applying those provisions, reference to ``MA organization'' and 
``financially responsible'' must be read as reference to the entities 
responsible for Medicaid payment, as specified in paragraph (b) of this 
section, and payment rules governed by Title XIX of the Act and the 
States.
    (f) Applicability to PIHPs and PAHPs. To the extent that services 
required to treat an emergency medical condition fall within the scope 
of the services for which the PIHP or PAHP is responsible, the rules 
under this section apply.


Sec.  438.116  Solvency standards.

    (a) Requirement for assurances. (1) Each MCO, PIHP, and PAHP that 
is not a Federally qualified HMO (as defined in section 1310 of the 
Public Health Service Act) must provide assurances satisfactory to the 
State showing that its provision against the risk of insolvency is 
adequate to ensure that its Medicaid enrollees will not be liable for 
the MCO's, PIHP's, or PAHP's debts if the entity becomes insolvent.
    (2) Federally qualified HMOs, as defined in section 1310 of the 
Public Health Service Act, are exempt from this requirement.
    (b) Other requirements--(1) General rule. Except as provided in 
paragraph (b)(2) of this section, an MCO or PIHP, must meet the 
solvency standards established by the State for private health 
maintenance organizations, or be licensed or certified by the State as 
a risk-bearing entity.
    (2) Exception. Paragraph (b)(1) of this section does not apply to 
an MCO or PIHP that meets any of the following conditions:
    (i) Does not provide both inpatient hospital services and physician 
services.
    (ii) Is a public entity.
    (iii) Is (or is controlled by) one or more Federally qualified 
health centers and meets the solvency standards established by the 
State for those centers.
    (iv) Has its solvency guaranteed by the State.

Subpart D--MCO, PIHP and PAHP Standards


Sec.  438.206  Availability of services.

    (a) Basic rule. Each State must ensure that all services covered 
under the State plan are available and accessible to enrollees of MCOs, 
PIHPs, and PAHPs in a timely manner. The State must also ensure that 
MCO, PIHP and PAHP provider networks for services covered under the 
contract meet the standards developed by the State in accordance with 
Sec.  438.68.
    (b) Delivery network. The State must ensure, through its contracts, 
that each MCO, PIHP and PAHP, consistent with the scope of its 
contracted services, meets the following requirements:
    (1) Maintains and monitors a network of appropriate providers that 
is supported by written agreements and is sufficient to provide 
adequate access to all services covered under the contract for all 
enrollees, including those with limited English proficiency or physical 
or mental disabilities.
    (2) Provides female enrollees with direct access to a women's 
health specialist within the provider network for covered care 
necessary to provide women's routine and preventive health care 
services. This is in addition to the enrollee's designated source of 
primary care if that source is not a women's health specialist.
    (3) Provides for a second opinion from a network provider, or 
arranges for the enrollee to obtain one outside the network, at no cost 
to the enrollee.
    (4) If the provider network is unable to provide necessary 
services, covered under the contract, to a particular enrollee, the 
MCO, PIHP, or PAHP must adequately and timely cover these services out 
of network for the enrollee, for as long as the MCO, PIHP, or PAHP's 
provider network is unable to provide them.
    (5) Requires out-of-network providers to coordinate with the MCO, 
PIHP, or PAHP for payment and ensures the cost to the enrollee is no 
greater than it would be if the services were furnished within the 
network.
    (6) Demonstrates that its network providers are credentialed as 
required by Sec.  438.214.
    (7) Demonstrates that its network includes sufficient family 
planning providers to ensure timely access to covered services.
    (c) Furnishing of services. The State must ensure that each 
contract with a MCO, PIHP, and PAHP complies with the following 
requirements.
    (1) Timely access. Each MCO, PIHP, and PAHP must do the following:
    (i) Meet and require its network providers to meet State standards 
for timely access to care and services, taking into account the urgency 
of the need for services.
    (ii) Ensure that the network providers offer hours of operation 
that are no less than the hours of operation offered to commercial 
enrollees or comparable to Medicaid FFS, if the provider serves only 
Medicaid enrollees.
    (iii) Make services included in the contract available 24 hours a 
day, 7 days a week, when medically necessary.
    (iv) Establish mechanisms to ensure compliance by network 
providers.
    (v) Monitor network providers regularly to determine compliance.
    (vi) Take corrective action if there is a failure to comply by a 
network provider.
    (2) Access and cultural considerations. Each MCO, PIHP, and PAHP 
participates in the State's efforts to promote the delivery of services 
in a culturally competent manner to all enrollees, including those with 
limited English proficiency and diverse cultural and ethnic 
backgrounds, disabilities, and regardless of gender, sexual orientation 
or gender identity.
    (3) Accessibility considerations. Each MCO, PIHP, and PAHP must 
ensure that network providers provide physical access, reasonable 
accommodations, and accessible equipment for Medicaid enrollees with 
physical or mental disabilities.
    (d) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, and PAHPs beginning on or after July 1, 
2018. Until that applicability date, states are required to continue to 
comply with Sec.  438.206 contained in the 42 CFR parts 430 to 481, 
edition revised as of October 1, 2015.

[[Page 27878]]

Sec.  438.207  Assurances of adequate capacity and services.

    (a) Basic rule. The State must ensure, through its contracts, that 
each MCO, PIHP, and PAHP gives assurances to the State and provides 
supporting documentation that demonstrates that it has the capacity to 
serve the expected enrollment in its service area in accordance with 
the State's standards for access to care under this part, including the 
standards at Sec.  438.68 and Sec.  438.206(c)(1).
    (b) Nature of supporting documentation. Each MCO, PIHP, and PAHP 
must submit documentation to the State, in a format specified by the 
State, to demonstrate that it complies with the following requirements:
    (1) Offers an appropriate range of preventive, primary care, 
specialty services, and LTSS that is adequate for the anticipated 
number of enrollees for the service area.
    (2) Maintains a network of providers that is sufficient in number, 
mix, and geographic distribution to meet the needs of the anticipated 
number of enrollees in the service area.
    (c) Timing of documentation. Each MCO, PIHP, and PAHP must submit 
the documentation described in paragraph (b) of this section as 
specified by the State, but no less frequently than the following:
    (1) At the time it enters into a contract with the State.
    (2) On an annual basis.
    (3) At any time there has been a significant change (as defined by 
the State) in the MCO's, PIHP's, or PAHP's operations that would affect 
the adequacy of capacity and services, including--
    (i) Changes in MCO, PIHP, or PAHP services, benefits, geographic 
service area, composition of or payments to its provider network; or
    (ii) Enrollment of a new population in the MCO, PIHP, or PAHP.
    (d) State review and certification to CMS. After the State reviews 
the documentation submitted by the MCO, PIHP, or PAHP, the State must 
submit an assurance of compliance to CMS that the MCO, PIHP, or PAHP 
meets the State's requirements for availability of services, as set 
forth in Sec.  438.68 and Sec.  438.206. The submission to CMS must 
include documentation of an analysis that supports the assurance of the 
adequacy of the network for each contracted MCO, PIHP or PAHP related 
to its provider network.
    (e) CMS' right to inspect documentation. The State must make 
available to CMS, upon request, all documentation collected by the 
State from the MCO, PIHP, or PAHP.
    (f) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, and PAHPs beginning on or after July 1, 
2018. Until that applicability date, states are required to continue to 
comply with Sec.  438.207 contained in the 42 CFR parts 430 to 481, 
edition revised as of October 1, 2015.


Sec.  438.208  Coordination and continuity of care.

    (a) Basic requirement--(1) General rule. Except as specified in 
paragraphs (a)(2) and (3) of this section, the State must ensure 
through its contracts, that each MCO, PIHP, and PAHP complies with the 
requirements of this section.
    (2) PIHP and PAHP exception. For PIHPs and PAHPs, the State 
determines, based on the scope of the entity's services, and on the way 
the State has organized the delivery of managed care services, whether 
a particular PIHP or PAHP is required to implement mechanisms for 
identifying, assessing, and producing a treatment plan for an 
individual with special health care needs, as specified in paragraph 
(c) of this section.
    (3) Exception for MCOs that serve dually eligible enrollees. (i) 
For each MCO that serves enrollees who are also enrolled in and receive 
Medicare benefits from a Medicare Advantage Organization (as defined in 
Sec.  422.2 of this chapter), the State determines to what extent the 
MCO must meet the identification, assessment, and treatment planning 
provisions of paragraph (c) of this section for dually eligible 
individuals.
    (ii) The State bases its determination on the needs of the 
population it requires the MCO to serve.
    (b) Care and coordination of services for all MCO, PIHP, and PAHP 
enrollees. Each MCO, PIHP, and PAHP must implement procedures to 
deliver care to and coordinate services for all MCO, PIHP, and PAHP 
enrollees. These procedures must meet State requirements and must do 
the following:
    (1) Ensure that each enrollee has an ongoing source of care 
appropriate to his or her needs and a person or entity formally 
designated as primarily responsible for coordinating the services 
accessed by the enrollee. The enrollee must be provided information on 
how to contact their designated person or entity;
    (2) Coordinate the services the MCO, PIHP, or PAHP furnishes to the 
enrollee:
    (i) Between settings of care, including appropriate discharge 
planning for short term and long-term hospital and institutional stays;
    (ii) With the services the enrollee receives from any other MCO, 
PIHP, or PAHP;
    (iii) With the services the enrollee receives in FFS Medicaid; and
    (iv) With the services the enrollee receives from community and 
social support providers.
    (3) Provide that the MCO, PIHP or PAHP makes a best effort to 
conduct an initial screening of each enrollee's needs, within 90 days 
of the effective date of enrollment for all new enrollees, including 
subsequent attempts if the initial attempt to contact the enrollee is 
unsuccessful;
    (4) Share with the State or other MCOs, PIHPs, and PAHPs serving 
the enrollee the results of any identification and assessment of that 
enrollee's needs to prevent duplication of those activities;
    (5) Ensure that each provider furnishing services to enrollees 
maintains and shares, as appropriate, an enrollee health record in 
accordance with professional standards; and
    (6) Ensure that in the process of coordinating care, each 
enrollee's privacy is protected in accordance with the privacy 
requirements in 45 CFR parts 160 and 164 subparts A and E, to the 
extent that they are applicable.
    (c) Additional services for enrollees with special health care 
needs or who need LTSS--(1) Identification. The State must implement 
mechanisms to identify persons who need LTSS or persons with special 
health care needs to MCOs, PIHPs and PAHPs, as those persons are 
defined by the State. These identification mechanisms--
    (i) Must be specified in the State's quality strategy under Sec.  
438.340.
    (ii) May use State staff, the State's enrollment broker, or the 
State's MCOs, PIHPs and PAHPs.
    (2) Assessment. Each MCO, PIHP, and PAHP must implement mechanisms 
to comprehensively assess each Medicaid enrollee identified by the 
State (through the mechanism specified in paragraph (c)(1) of this 
section) and identified to the MCO, PIHP, and PAHP by the State as 
needing LTSS or having special health care needs to identify any 
ongoing special conditions of the enrollee that require a course of 
treatment or regular care monitoring. The assessment mechanisms must 
use appropriate providers or individuals meeting LTSS service 
coordination requirements of the State or the MCO, PIHP, or PAHP as 
appropriate.
    (3) Treatment/service plans. MCOs, PIHPs, or PAHPs must produce a 
treatment or service plan meeting the criteria in paragraphs (c)(3)(i) 
through (v) of this section for enrollees who

[[Page 27879]]

require LTSS and, if the State requires, must produce a treatment or 
service plan meeting the criteria in paragraphs (c)(3)(iii) through (v) 
of this section for enrollees with special health care needs that are 
determined through assessment to need a course of treatment or regular 
care monitoring. The treatment or service plan must be:
    (i) Developed by an individual meeting LTSS service coordination 
requirements with enrollee participation, and in consultation with any 
providers caring for the enrollee;
    (ii) Developed by a person trained in person-centered planning 
using a person-centered process and plan as defined in Sec.  
441.301(c)(1) and (2) of this chapter for LTSS treatment or service 
plans;
    (iii) Approved by the MCO, PIHP, or PAHP in a timely manner, if 
this approval is required by the MCO, PIHP, or PAHP;
    (iv) In accordance with any applicable State quality assurance and 
utilization review standards; and
    (v) Reviewed and revised upon reassessment of functional need, at 
least every 12 months, or when the enrollee's circumstances or needs 
change significantly, or at the request of the enrollee per Sec.  
441.301(c)(3) of this chapter.
    (4) Direct access to specialists. For enrollees with special health 
care needs determined through an assessment (consistent with paragraph 
(c)(2) of this section) to need a course of treatment or regular care 
monitoring, each MCO, PIHP, and PAHP must have a mechanism in place to 
allow enrollees to directly access a specialist (for example, through a 
standing referral or an approved number of visits) as appropriate for 
the enrollee's condition and identified needs.
    (d) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, and PAHPs beginning on or after July 1, 
2017. Until that applicability date, states are required to continue to 
comply with Sec.  438.208 contained in the 42 CFR parts 430 to 481, 
edition revised as of October 1, 2015.


Sec.  438.210  Coverage and authorization of services.

    (a) Coverage. Each contract between a State and an MCO, PIHP, or 
PAHP must do the following:
    (1) Identify, define, and specify the amount, duration, and scope 
of each service that the MCO, PIHP, or PAHP is required to offer.
    (2) Require that the services identified in paragraph (a)(1) of 
this section be furnished in an amount, duration, and scope that is no 
less than the amount, duration, and scope for the same services 
furnished to beneficiaries under FFS Medicaid, as set forth in Sec.  
440.230 of this chapter, and for enrollees under the age of 21, as set 
forth in subpart B of part 440 of this chapter.
    (3) Provide that the MCO, PIHP, or PAHP--
    (i) Must ensure that the services are sufficient in amount, 
duration, or scope to reasonably achieve the purpose for which the 
services are furnished.
    (ii) May not arbitrarily deny or reduce the amount, duration, or 
scope of a required service solely because of diagnosis, type of 
illness, or condition of the beneficiary.
    (4) Permit an MCO, PIHP, or PAHP to place appropriate limits on a 
service--
    (i) On the basis of criteria applied under the State plan, such as 
medical necessity; or
    (ii) For the purpose of utilization control, provided that--
    (A) The services furnished can reasonably achieve their purpose, as 
required in paragraph (a)(3)(i) of this section;
    (B) The services supporting individuals with ongoing or chronic 
conditions or who require long-term services and supports are 
authorized in a manner that reflects the enrollee's ongoing need for 
such services and supports; and
    (C) Family planning services are provided in a manner that protects 
and enables the enrollee's freedom to choose the method of family 
planning to be used consistent with Sec.  441.20 of this chapter.
    (5) Specify what constitutes ``medically necessary services'' in a 
manner that--
    (i) Is no more restrictive than that used in the State Medicaid 
program, including quantitative and non-quantitative treatment limits, 
as indicated in State statutes and regulations, the State Plan, and 
other State policy and procedures; and
    (ii) Addresses the extent to which the MCO, PIHP, or PAHP is 
responsible for covering services that address:
    (A) The prevention, diagnosis, and treatment of an enrollee's 
disease, condition, and/or disorder that results in health impairments 
and/or disability.
    (B) The ability for an enrollee to achieve age-appropriate growth 
and development.
    (C) The ability for an enrollee to attain, maintain, or regain 
functional capacity.
    (D) The opportunity for an enrollee receiving long-term services 
and supports to have access to the benefits of community living, to 
achieve person-centered goals, and live and work in the setting of 
their choice.
    (b) Authorization of services. For the processing of requests for 
initial and continuing authorizations of services, each contract must 
require--
    (1) That the MCO, PIHP, or PAHP and its subcontractors have in 
place, and follow, written policies and procedures.
    (2) That the MCO, PIHP, or PAHP--
    (i) Have in effect mechanisms to ensure consistent application of 
review criteria for authorization decisions.
    (ii) Consult with the requesting provider for medical services when 
appropriate.
    (iii) Authorize LTSS based on an enrollee's current needs 
assessment and consistent with the person-centered service plan.
    (3) That any decision to deny a service authorization request or to 
authorize a service in an amount, duration, or scope that is less than 
requested, be made by an individual who has appropriate expertise in 
addressing the enrollee's medical, behavioral health, or long-term 
services and supports needs.
    (c) Notice of adverse benefit determination. Each contract must 
provide for the MCO, PIHP, or PAHP to notify the requesting provider, 
and give the enrollee written notice of any decision by the MCO, PIHP, 
or PAHP to deny a service authorization request, or to authorize a 
service in an amount, duration, or scope that is less than requested. 
For MCOs, PIHPs, and PAHPs, the enrollee's notice must meet the 
requirements of Sec.  438.404.
    (d) Timeframe for decisions. Each MCO, PIHP, or PAHP contract must 
provide for the following decisions and notices:
    (1) Standard authorization decisions. For standard authorization 
decisions, provide notice as expeditiously as the enrollee's condition 
requires and within State-established timeframes that may not exceed 14 
calendar days following receipt of the request for service, with a 
possible extension of up to 14 additional calendar days, if--
    (i) The enrollee, or the provider, requests extension; or
    (ii) The MCO, PIHP, or PAHP justifies (to the State agency upon 
request) a need for additional information and how the extension is in 
the enrollee's interest.
    (2) Expedited authorization decisions. (i) For cases in which a 
provider indicates, or the MCO, PIHP, or PAHP determines, that 
following the standard timeframe could seriously jeopardize the 
enrollee's life or health or ability to attain, maintain, or regain 
maximum function, the MCO, PIHP, or PAHP must

[[Page 27880]]

make an expedited authorization decision and provide notice as 
expeditiously as the enrollee's health condition requires and no later 
than 72 hours after receipt of the request for service.
    (ii) The MCO, PIHP, or PAHP may extend the 72 hour time period by 
up to 14 calendar days if the enrollee requests an extension, or if the 
MCO, PIHP, or PAHP justifies (to the State agency upon request) a need 
for additional information and how the extension is in the enrollee's 
interest.
    (3) Covered outpatient drug decisions. For all covered outpatient 
drug authorization decisions, provide notice as described in section 
1927(d)(5)(A) of the Act.
    (e) Compensation for utilization management activities. Each 
contract between a State and MCO, PIHP, or PAHP must provide that, 
consistent with Sec.  438.3(i), and Sec.  422.208 of this chapter, 
compensation to individuals or entities that conduct utilization 
management activities is not structured so as to provide incentives for 
the individual or entity to deny, limit, or discontinue medically 
necessary services to any enrollee.
    (f) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, and PAHPs beginning on or after July 1, 
2017. Until that applicability date, states are required to continue to 
comply with Sec.  438.210 contained in the 42 CFR parts 430 to 481, 
edition revised as of October 1, 2015.


Sec.  438.214  Provider selection.

    (a) General rules. The State must ensure, through its contracts, 
that each MCO, PIHP, or PAHP implements written policies and procedures 
for selection and retention of network providers and that those 
policies and procedures, at a minimum, meet the requirements of this 
section.
    (b) Credentialing and recredentialing requirements. (1) Each State 
must establish a uniform credentialing and recredentialing policy that 
addresses acute, primary, behavioral, substance use disorders, and LTSS 
providers, as appropriate, and requires each MCO, PIHP and PAHP to 
follow those policies.
    (2) Each MCO, PIHP, and PAHP must follow a documented process for 
credentialing and recredentialing of network providers.
    (c) Nondiscrimination. MCO, PIHP, and PAHP network provider 
selection policies and procedures, consistent with Sec.  438.12, must 
not discriminate against particular providers that serve high-risk 
populations or specialize in conditions that require costly treatment.
    (d) Excluded providers. (1) MCOs, PIHPs, and PAHPs may not employ 
or contract with providers excluded from participation in Federal 
health care programs under either section 1128 or section 1128A of the 
Act.
    (e) State requirements. Each MCO, PIHP, and PAHP must comply with 
any additional requirements established by the State.


Sec.  438.224  Confidentiality.

    The State must ensure, through its contracts, that (consistent with 
subpart F of part 431 of this chapter), for medical records and any 
other health and enrollment information that identifies a particular 
enrollee, each MCO, PIHP, and PAHP uses and discloses such individually 
identifiable health information in accordance with the privacy 
requirements in 45 CFR parts 160 and 164, subparts A and E, to the 
extent that these requirements are applicable.


Sec.  438.228  Grievance and appeal systems.

    (a) The State must ensure, through its contracts, that each MCO, 
PIHP, and PAHP has in effect a grievance and appeal system that meets 
the requirements of subpart F of this part.
    (b) If the State delegates to the MCO, PIHP, or PAHP responsibility 
for notice of action under subpart E of part 431 of this chapter, the 
State must conduct random reviews of each delegated MCO, PIHP, or PAHP 
and its providers and subcontractors to ensure that they are notifying 
enrollees in a timely manner.


Sec.  438.230  Subcontractual relationships and delegation.

    (a) Applicability. The requirements of this section apply to any 
contract or written arrangement that an MCO, PIHP, PAHP, or PCCM entity 
has with any subcontractor.
    (b) General rule. The State must ensure, through its contracts with 
MCOs, PIHPs, PAHPs, and PCCM entities that--
    (1) Notwithstanding any relationship(s) that the MCO, PIHP, PAHP, 
or PCCM entity may have with any subcontractor, the MCO, PIHP, PAHP, or 
PCCM entity maintains ultimate responsibility for adhering to and 
otherwise fully complying with all terms and conditions of its contract 
with the State; and
    (2) All contracts or written arrangements between the MCO, PIHP, 
PAHP, or PCCM entity and any subcontractor must meet the requirements 
of paragraph (c) of this section.
    (c) Each contract or written arrangement described in paragraph 
(b)(2) of this section must specify that:
    (1) If any of the MCO's, PIHP's, PAHP's, or PCCM entity's 
activities or obligations under its contract with the State are 
delegated to a subcontractor--
    (i) The delegated activities or obligations, and related reporting 
responsibilities, are specified in the contract or written agreement.
    (ii) The subcontractor agrees to perform the delegated activities 
and reporting responsibilities specified in compliance with the MCO's, 
PIHP's, PAHP's, or PCCM entity's contract obligations.
    (iii) The contract or written arrangement must either provide for 
revocation of the delegation of activities or obligations, or specify 
other remedies in instances where the State or the MCO, PIHP, PAHP, or 
PCCM entity determine that the subcontractor has not performed 
satisfactorily.
    (2) The subcontractor agrees to comply with all applicable Medicaid 
laws, regulations, including applicable subregulatory guidance and 
contract provisions;
    (3) The subcontractor agrees that--
    (i) The State, CMS, the HHS Inspector General, the Comptroller 
General, or their designees have the right to audit, evaluate, and 
inspect any books, records, contracts, computer or other electronic 
systems of the subcontractor, or of the subcontractor's contractor, 
that pertain to any aspect of services and activities performed, or 
determination of amounts payable under the MCO's, PIHP's, or PAHP's 
contract with the State.
    (ii) The subcontractor will make available, for purposes of an 
audit, evaluation, or inspection under paragraph (c)(3)(i) of this 
section, its premises, physical facilities, equipment, books, records, 
contracts, computer or other electronic systems relating to its 
Medicaid enrollees.
    (iii) The right to audit under paragraph (c)(3)(i) of this section 
will exist through 10 years from the final date of the contract period 
or from the date of completion of any audit, whichever is later.
    (iv) If the State, CMS, or the HHS Inspector General determines 
that there is a reasonable possibility of fraud or similar risk, the 
State, CMS, or the HHS Inspector General may inspect, evaluate, and 
audit the subcontractor at any time.
    (d) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, PAHPs, and PCCM entities beginning on 
or after July 1, 2017. Until that applicability date, states are 
required to continue to comply with Sec.  438.230 contained in the 42 
CFR parts 430 to 481, edition revised as of October 1, 2015.

[[Page 27881]]

Sec.  438.236  Practice guidelines.

    (a) Basic rule. The State must ensure, through its contracts, that 
each MCO, PIHP, and PAHP meets the requirements of this section.
    (b) Adoption of practice guidelines. Each MCO and, when applicable, 
each PIHP and PAHP adopts practice guidelines that meet the following 
requirements:
    (1) Are based on valid and reliable clinical evidence or a 
consensus of providers in the particular field.
    (2) Consider the needs of the MCO's, PIHP's, or PAHP's enrollees.
    (3) Are adopted in consultation with contracting health care 
professionals.
    (4) Are reviewed and updated periodically as appropriate.
    (c) Dissemination of guidelines. Each MCO, PIHP, and PAHP 
disseminates the guidelines to all affected providers and, upon 
request, to enrollees and potential enrollees.
    (d) Application of guidelines. Decisions for utilization 
management, enrollee education, coverage of services, and other areas 
to which the guidelines apply are consistent with the guidelines.


Sec.  438.242  Health information systems.

    (a) General rule. The State must ensure, through its contracts that 
each MCO, PIHP, and PAHP maintains a health information system that 
collects, analyzes, integrates, and reports data and can achieve the 
objectives of this part. The systems must provide information on areas 
including, but not limited to, utilization, claims, grievances and 
appeals, and disenrollments for other than loss of Medicaid 
eligibility.
    (b) Basic elements of a health information system. The State must 
require, at a minimum, that each MCO, PIHP, and PAHP comply with the 
following:
    (1) Section 6504(a) of the Affordable Care Act, which requires that 
State claims processing and retrieval systems are able to collect data 
elements necessary to enable the mechanized claims processing and 
information retrieval systems in operation by the State to meet the 
requirements of section 1903(r)(1)(F) of the Act.
    (2) Collect data on enrollee and provider characteristics as 
specified by the State, and on all services furnished to enrollees 
through an encounter data system or other methods as may be specified 
by the State.
    (3) Ensure that data received from providers is accurate and 
complete by--
    (i) Verifying the accuracy and timeliness of reported data, 
including data from network providers the MCO, PIHP, or PAHP is 
compensating on the basis of capitation payments.
    (ii) Screening the data for completeness, logic, and consistency.
    (iii) Collecting data from providers in standardized formats to the 
extent feasible and appropriate, including secure information exchanges 
and technologies utilized for State Medicaid quality improvement and 
care coordination efforts.
    (4) Make all collected data available to the State and upon request 
to CMS.
    (c) Enrollee encounter data. Contracts between a State and a MCO, 
PIHP, or PAHP must provide for:
    (1) Collection and maintenance of sufficient enrollee encounter 
data to identify the provider who delivers any item(s) or service(s) to 
enrollees.
    (2) Submission of enrollee encounter data to the State at a 
frequency and level of detail to be specified by CMS and the State, 
based on program administration, oversight, and program integrity 
needs.
    (3) Submission of all enrollee encounter data that the State is 
required to report to CMS under Sec.  438.818.
    (4) Specifications for submitting encounter data to the State in 
standardized ASC X12N 837 and NCPDP formats, and the ASC X12N 835 
format as appropriate.
    (d) State review and validation of encounter data. The State must 
review and validate that the encounter data collected, maintained, and 
submitted to the State by the MCO, PIHP, or PAHP, meets the 
requirements of this section. The State must have procedures and 
quality assurance protocols to ensure that enrollee encounter data 
submitted under paragraph (c) of this section is a complete and 
accurate representation of the services provided to the enrollees under 
the contract between the State and the MCO, PIHP, or PAHP.
    (e) Applicability date. This section applies to the rating period 
for contracts with MCOs, PIHPs, PAHPs, and PCCM entities beginning on 
or after July 1, 2017. Until that applicability date, states are 
required to continue to comply with Sec.  438.242 contained in the 42 
CFR parts 430 to 481, edition revised as of October 1, 2015.

Subpart E--Quality Measurement and Improvement; External Quality 
Review


Sec.  438.310  Basis, scope, and applicability.

    (a) Statutory basis. This subpart is based on sections 1932(c), 
1903(a)(3)(C)(ii), 1902(a)(4), and 1902(a)(19) of the Act.
    (b) Scope. This subpart sets forth:
    (1) Specifications for a quality assessment and performance 
improvement program that States must require each contracting MCO, 
PIHP, and PAHP to implement and maintain.
    (2) Requirements for the State review of the accreditation status 
of all contracting MCOs, PIHPs, and PAHPs.
    (3) Specifications for a Medicaid managed care quality rating 
system for all States contracting with MCOs, PIHPs, and PAHPs.
    (4) Specifications for a Medicaid managed care quality strategy 
that States contracting with MCOs, PIHPs, PAHPs, and PCCM entities 
(described in paragraph (c)(2) of this section) must implement to 
ensure the delivery of quality health care.
    (5) Requirements for annual external quality reviews of each 
contracting MCO, PIHP, PAHP and PCCM entity (described in paragraph 
(c)(2) of this section) including--
    (i) Criteria that States must use in selecting entities to perform 
the reviews.
    (ii) Specifications for the activities related to external quality 
review.
    (iii) Circumstances under which external quality review may use the 
results of Medicare quality reviews or private accreditation reviews.
    (iv) Requirements for making the results of the reviews publicly 
available.
    (c) Applicability. (1) The provisions of this subpart apply to 
States contracting with MCOs, PIHPs, and PAHPs for the delivery of 
services covered under Medicaid.
    (2) The provisions of Sec.  438.330(b)(2), (b)(3), (c), and (e), 
Sec.  438.340, and Sec.  438.350 apply to States contracting with PCCM 
entities whose contracts with the State provide for shared savings, 
incentive payments or other financial reward for the PCCM entity for 
improved quality outcomes.
    (d) Applicability dates. States will not be held out of compliance 
with the following requirements of this subpart prior to the dates 
noted below so long as they comply with the corresponding standard(s) 
in 42 CFR part 438 contained in the 42 CFR parts 430 to 481, edition 
revised as of October 1, 2015:
    (1) States must comply with Sec.  438.330 and Sec.  438.332 no 
later than the rating period for contracts beginning on or after July 
1, 2017.
    (2) States must comply with Sec.  438.340, Sec.  438.350, Sec.  
438.354, Sec.  438.356, Sec.  438.358, Sec.  438.360, Sec.  438.362, 
and Sec.  438.364 no later than July 1, 2018.


Sec.  438.320  Definitions.

    As used in this subpart--
    Access, as it pertains to external quality review, means the timely 
use of services to achieve optimal outcomes, as evidenced by managed 
care plans

[[Page 27882]]

successfully demonstrating and reporting on outcome information for the 
availability and timeliness elements defined under Sec.  438.68 
(Network adequacy standards) and Sec.  438.206 (Availability of 
services).
    EQR stands for external quality review.
    EQRO stands for external quality review organization.
    External quality review means the analysis and evaluation by an 
EQRO, of aggregated information on quality, timeliness, and access to 
the health care services that an MCO, PIHP, PAHP, or PCCM entity 
(described in Sec.  438.310(c)(2)), or their contractors furnish to 
Medicaid beneficiaries.
    External quality review organization means an organization that 
meets the competence and independence requirements set forth in Sec.  
438.354, and performs external quality review, other EQR-related 
activities as set forth in Sec.  438.358, or both.
    Financial relationship means--
    (1) A direct or indirect ownership or investment interest 
(including an option or nonvested interest) in any entity. This direct 
or indirect interest may be in the form of equity, debt, or other 
means, and includes any indirect ownership or investment interest no 
matter how many levels removed from a direct interest; or
    (2) A compensation arrangement with an entity.
    Health care services means all Medicaid services provided by an 
MCO, PIHP, or PAHP under contract with the State Medicaid agency in any 
setting, including but not limited to medical care, behavioral health 
care, and long-term services and supports.
    Outcomes means changes in patient health, functional status, 
satisfaction or goal achievement that result from health care or 
supportive services.
    Quality, as it pertains to external quality review, means the 
degree to which an MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)) increases the likelihood of desired outcomes of its 
enrollees through:
    (1) Its structural and operational characteristics.
    (2) The provision of services that are consistent with current 
professional, evidenced-based-knowledge.
    (3) Interventions for performance improvement.
    Validation means the review of information, data, and procedures to 
determine the extent to which they are accurate, reliable, free from 
bias, and in accord with standards for data collection and analysis.


Sec.  438.330  Quality assessment and performance improvement program.

    (a) General rules. (1) The State must require, through its 
contracts, that each MCO, PIHP, and PAHP establish and implement an 
ongoing comprehensive quality assessment and performance improvement 
program for the services it furnishes to its enrollees that includes 
the elements identified in paragraph (b) of this section.
    (2) After consulting with States and other stakeholders and 
providing public notice and opportunity to comment, CMS may specify 
performance measures and PIPs, which must be included in the standard 
measures identified and PIPs required by the State in accordance with 
paragraphs (c) and (d) of this section. A State may request an 
exemption from including the performance measures or PIPs established 
under paragraph (a)(2) of this section, by submitting a written request 
to CMS explaining the basis for such request.
    (3) The State must require, through its contracts, that each PCCM 
entity described in Sec.  438.310(c)(2) establish and implement an 
ongoing comprehensive quality assessment and performance improvement 
program for the services it furnishes to its enrollees which 
incorporates, at a minimum, paragraphs (b)(2) and (3) of this section 
and the performance measures identified by the State per paragraph (c) 
of this section.
    (b) Basic elements of quality assessment and performance 
improvement programs. The comprehensive quality assessment and 
performance improvement program described in paragraph (a) of this 
section must include at least the following elements:
    (1) Performance improvement projects in accordance with paragraph 
(d) of this section.
    (2) Collection and submission of performance measurement data in 
accordance with paragraph (c) of this section.
    (3) Mechanisms to detect both underutilization and overutilization 
of services.
    (4) Mechanisms to assess the quality and appropriateness of care 
furnished to enrollees with special health care needs, as defined by 
the State in the quality strategy under Sec.  438.340.
    (5) For MCOs, PIHPs, or PAHPs providing long-term services and 
supports:
    (i) Mechanisms to assess the quality and appropriateness of care 
furnished to enrollees using long-term services and supports, including 
assessment of care between care settings and a comparison of services 
and supports received with those set forth in the enrollee's treatment/
service plan, if applicable; and
    (ii) Participate in efforts by the State to prevent, detect, and 
remediate critical incidents (consistent with assuring beneficiary 
health and welfare per Sec. Sec.  441.302 and 441.730(a) of this 
chapter) that are based, at a minimum, on the requirements on the State 
for home and community-based waiver programs per Sec.  441.302(h) of 
this chapter.
    (c) Performance measurement. The State must--
    (1)(i) Identify standard performance measures, including those 
performance measures that may be specified by CMS under paragraph 
(a)(2) of this section, relating to the performance of MCOs, PIHPs, and 
PAHPs; and
    (ii) In addition to the measures specified in paragraph (c)(1)(i) 
of this section, in the case of an MCO, PIHP, or PAHP providing long-
term services and supports, identify standard performance measures 
relating to quality of life, rebalancing, and community integration 
activities for individuals receiving long-term services and supports.
    (2) Require that each MCO, PIHP, and PAHP annually--
    (i) Measure and report to the State on its performance, using the 
standard measures required by the State in paragraph (c)(1) of this 
section;
    (ii) Submit to the State data, specified by the State, which 
enables the State to calculate the MCO's, PIHP's, or PAHP's performance 
using the standard measures identified by the State under paragraph 
(c)(1) of this section; or
    (iii) Perform a combination of the activities described in 
paragraphs (c)(2)(i) and (ii) of this section.
    (d) Performance improvement projects. (1) The State must require 
that MCOs, PIHPs, and PAHPs conduct performance improvement projects, 
including any performance improvement projects required by CMS in 
accordance with paragraph (a)(2) of this section, that focus on both 
clinical and nonclinical areas.
    (2) Each performance improvement project must be designed to 
achieve significant improvement, sustained over time, in health 
outcomes and enrollee satisfaction, and must include the following 
elements:
    (i) Measurement of performance using objective quality indicators.
    (ii) Implementation of interventions to achieve improvement in the 
access to and quality of care.
    (iii) Evaluation of the effectiveness of the interventions based on 
the performance measures in paragraph (d)(2)(i) of this section.

[[Page 27883]]

    (iv) Planning and initiation of activities for increasing or 
sustaining improvement.
    (3) The State must require each MCO, PIHP, and PAHP to report the 
status and results of each project conducted per paragraph (d)(1) of 
this section to the State as requested, but not less than once per 
year.
    (4) The State may permit an MCO, PIHP, or PAHP exclusively serving 
dual eligibles to substitute an MA Organization quality improvement 
project conducted under Sec.  422.152(d) of this chapter for one or 
more of the performance improvement projects otherwise required under 
this section.
    (e) Program review by the State. (1) The State must review, at 
least annually, the impact and effectiveness of the quality assessment 
and performance improvement program of each MCO, PIHP, PAHP, and PCCM 
entity described in Sec.  438.310(c)(2). The review must include--
    (i) The MCO's, PIHP's, PAHP's, and PCCM entity's performance on the 
measures on which it is required to report.
    (ii) The outcomes and trended results of each MCO's, PIHP's, and 
PAHP's performance improvement projects.
    (iii) The results of any efforts by the MCO, PIHP, or PAHP to 
support community integration for enrollees using long-term services 
and supports.
    (2) The State may require that an MCO, PIHP, PAHP, or PCCM entity 
described in Sec.  438.310(c)(2) develop a process to evaluate the 
impact and effectiveness of its own quality assessment and performance 
improvement program.


Sec.  438.332  State review of the accreditation status of MCOs, PIHPs, 
and PAHPs.

    (a) The State must require, through its contracts, that each MCO, 
PIHP, and PAHP inform the State whether it has been accredited by a 
private independent accrediting entity.
    (b) The State must require, through its contracts, that each MCO, 
PIHP, and PAHP that has received accreditation by a private independent 
accrediting entity must authorize the private independent accrediting 
entity to provide the State a copy of its most recent accreditation 
review, including:
    (1) Accreditation status, survey type, and level (as applicable);
    (2) Accreditation results, including recommended actions or 
improvements, corrective action plans, and summaries of findings; and
    (3) Expiration date of the accreditation.
    (c) The State must--
    (1) Make the accreditation status for each contracted MCO, PIHP, 
and PAHP available on the Web site required under Sec.  438.10(c)(3), 
including whether each MCO, PIHP, and PAHP has been accredited and, if 
applicable, the name of the accrediting entity, accreditation program, 
and accreditation level; and
    (2) Update this information at least annually.


Sec.  438.334  Medicaid managed care quality rating system.

    (a) General rule. Each State contracting with an MCO, PIHP or PAHP 
to furnish services to Medicaid beneficiaries must--
    (1) Adopt the Medicaid managed care quality rating system developed 
by CMS in accordance with paragraph (b) of this section; or
    (2) Adopt an alternative Medicaid managed care quality rating 
system in accordance with paragraph (c) of this section.
    (3) Implement such Medicaid managed care quality rating system 
within 3 years of the date of a final notice published in the Federal 
Register.
    (b) Quality rating system. CMS, in consultation with States and 
other stakeholders and after providing public notice and opportunity to 
comment, will identify performance measures and a methodology for a 
Medicaid managed care quality rating system that aligns with the 
summary indicators of the qualified health plan quality rating system 
developed per 45 CFR 156.1120.
    (c) Alternative quality rating system. (1) A State may submit a 
request to CMS for approval to use an alternative Medicaid managed care 
quality rating system that utilizes different performance measures or 
applies a different methodology from that described in paragraph (b) of 
this section provided that--
    (i) The ratings generated by the alternative Medicaid managed care 
quality rating system yield information regarding MCO, PIHP, and PAHP 
performance which is substantially comparable to that yielded by the 
Medicaid managed care quality rating system described in paragraph (b) 
of this section; and,
    (ii) The state receive CMS approval prior to implementing an 
alternative quality rating system or modifications to an approved 
alternative Medicaid managed care quality rating system.
    (2) Prior to submitting a request for, or modification of, an 
alternative Medicaid managed care quality rating system to CMS, the 
State must--
    (i) Obtain input from the State's Medical Care Advisory Committee 
established under Sec.  431.12 of this chapter; and
    (ii) Provide an opportunity for public comment of at least 30 days 
on the proposed alternative Medicaid managed care quality rating system 
or modification.
    (3) The State must document in the request to CMS the public 
comment process utilized by the State including discussion of the 
issues raised by the Medical Care Advisory Committee and the public. 
The request must document any policy revisions or modifications made in 
response to the comments and rationale for comments not accepted.
    (d) Quality ratings. Each year, the State must collect data from 
each MCO, PIHP, and PAHP with which it contracts and issue an annual 
quality rating for each MCO, PIHP, and PAHP based on the data 
collected, using the Medicaid managed care quality rating system 
adopted under this section.
    (e) Availability of information. The State must prominently display 
the quality rating given by the State to each MCO, PIHP, or PAHP under 
paragraph (d) of this section on the Web site required under Sec.  
438.10(c)(3) in a manner that complies with the standards in Sec.  
438.10(d).


Sec.  438.340  Managed care State quality strategy.

    (a) General rule. Each State contracting with an MCO, PIHP, or PAHP 
as defined in Sec.  438.2 or with a PCCM entity as described in Sec.  
438.310(c)(2) must draft and implement a written quality strategy for 
assessing and improving the quality of health care and services 
furnished by the MCO, PIHP, PAHP or PCCM entity.
    (b) Elements of the State quality strategy. At a minimum, the 
State's quality strategy must include the following:
    (1) The State-defined network adequacy and availability of services 
standards for MCOs, PIHPs, and PAHPs required by Sec. Sec.  438.68 and 
438.206 and examples of evidence-based clinical practice guidelines the 
State requires in accordance with Sec.  438.236.
    (2) The State's goals and objectives for continuous quality 
improvement which must be measurable and take into consideration the 
health status of all populations in the State served by the MCO, PIHP, 
and PAHP.
    (3) A description of--
    (i) The quality metrics and performance targets to be used in 
measuring the performance and improvement of each MCO, PIHP, and PAHP 
with which the State contracts, including but not limited to, the 
performance measures reported in accordance with Sec.  438.330(c). The 
State must identify which quality measures

[[Page 27884]]

and performance outcomes the State will publish at least annually on 
the Web site required under Sec.  438.10(c)(3); and
    (ii) The performance improvement projects to be implemented in 
accordance with Sec.  438.330(d), including a description of any 
interventions the State proposes to improve access, quality, or 
timeliness of care for beneficiaries enrolled in an MCO, PIHP, or PAHP.
    (4) Arrangements for annual, external independent reviews, in 
accordance with Sec.  438.350, of the quality outcomes and timeliness 
of, and access to, the services covered under each MCO, PIHP, PAHP, and 
PCCM entity (described in Sec.  438.310(c)(2)) contract.
    (5) A description of the State's transition of care policy required 
under Sec.  438.62(b)(3).
    (6) The State's plan to identify, evaluate, and reduce, to the 
extent practicable, health disparities based on age, race, ethnicity, 
sex, primary language, and disability status. States must identify this 
demographic information for each Medicaid enrollee and provide it to 
the MCO, PIHP or PAHP at the time of enrollment. For purposes of this 
paragraph (b)(6), ``disability status'' means whether the individual 
qualified for Medicaid on the basis of a disability.
    (7) For MCOs, appropriate use of intermediate sanctions that, at a 
minimum, meet the requirements of subpart I of this part.
    (8) A description of how the State will assess the performance and 
quality outcomes achieved by each PCCM entity described in Sec.  
438.310(c)(2).
    (9) The mechanisms implemented by the State to comply with Sec.  
438.208(c)(1) (relating to the identification of persons who need long-
term services and supports or persons with special health care needs).
    (10) The information required under Sec.  438.360(c) (relating to 
nonduplication of EQR activities); and
    (11) The State's definition of a ``significant change'' for the 
purposes of paragraph (c)(3)(ii) of this section.
    (c) Development, evaluation, and revision. In drafting or revising 
its quality strategy, the State must:
    (1) Make the strategy available for public comment before 
submitting the strategy to CMS for review, including:
    (i) Obtaining input from the Medical Care Advisory Committee 
(established by Sec.  431.12 of this chapter), beneficiaries, and other 
stakeholders.
    (ii) If the State enrolls Indians in the MCO, PIHP, or PAHP, 
consulting with Tribes in accordance with the State's Tribal 
consultation policy.
    (2) Review and update the quality strategy as needed, but no less 
than once every 3 years.
    (i) This review must include an evaluation of the effectiveness of 
the quality strategy conducted within the previous 3 years.
    (ii) The State must make the results of the review available on the 
Web site required under Sec.  438.10(c)(3).
    (iii) Updates to the quality strategy must take into consideration 
the recommendations provided pursuant to Sec.  438.364(a)(4).
    (3) Submit to CMS the following:
    (i) A copy of the initial strategy for CMS comment and feedback 
prior to adopting it in final.
    (ii) A copy of the revised strategy whenever significant changes, 
as defined in the state's quality strategy per paragraph (b)(11) of 
this section, are made to the document, or whenever significant changes 
occur within the State's Medicaid program.
    (d) Availability. The State must make the final quality strategy 
available on the Web site required under Sec.  438.10(c)(3).


Sec.  438.350  External quality review.

    Each State that contracts with MCOs, PIHPs, or PAHPs, or with PCCM 
entities (described in Sec.  438.310(c)(2)) must ensure that--
    (a) Except as provided in Sec.  438.362, a qualified EQRO performs 
an annual EQR for each such contracting MCO, PIHP, PAHP or PCCM entity 
(described in Sec.  438.310(c)(2)).
    (b) The EQRO has sufficient information to use in performing the 
review.
    (c) The information used to carry out the review must be obtained 
from the EQR-related activities described in Sec.  438.358 or, if 
applicable, from a Medicare or private accreditation review as 
described in Sec.  438.360.
    (d) For each EQR-related activity, the information gathered for use 
in the EQR must include the elements described in Sec.  
438.364(a)(1)(i) through (iv).
    (e) The information provided to the EQRO in accordance with 
paragraph (b) of this section is obtained through methods consistent 
with the protocols established by the Secretary in accordance with 
Sec.  438.352.
    (f) The results of the reviews are made available as specified in 
Sec.  438.364.


Sec.  438.352  External quality review protocols.

    The Secretary, in coordination with the National Governor's 
Association, must develop protocols for the external quality reviews 
required under this subpart. Each protocol issued by the Secretary must 
specify--
    (a) The data to be gathered;
    (b) The sources of the data;
    (c) The activities and steps to be followed in collecting the data 
to promote its accuracy, validity, and reliability;
    (d) The proposed method or methods for validly analyzing and 
interpreting the data once obtained; and
    (e) Instructions, guidelines, worksheets, and other documents or 
tools necessary for implementing the protocol.


Sec.  438.354  Qualifications of external quality review organizations.

    (a) General rule. The State must ensure that an EQRO meets the 
requirements of this section.
    (b) Competence. The EQRO must have at a minimum the following:
    (1) Staff with demonstrated experience and knowledge of--
    (i) Medicaid beneficiaries, policies, data systems, and processes;
    (ii) Managed care delivery systems, organizations, and financing;
    (iii) Quality assessment and improvement methods; and
    (iv) Research design and methodology, including statistical 
analysis.
    (2) Sufficient physical, technological, and financial resources to 
conduct EQR or EQR-related activities.
    (3) Other clinical and nonclinical skills necessary to carry out 
EQR or EQR-related activities and to oversee the work of any 
subcontractors.
    (c) Independence. The EQRO and its subcontractors must be 
independent from the State Medicaid agency and from the MCOs, PIHPs, 
PAHPs, or PCCM entities (described in Sec.  438.310(c)(2)) that they 
review. To qualify as ``independent''--
    (1) If a State agency, department, university, or other State 
entity:
    (i) May not have Medicaid purchasing or managed care licensing 
authority; and
    (ii) Must be governed by a Board or similar body the majority of 
whose members are not government employees.
    (2) An EQRO may not:
    (i) Review any MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)), or a competitor operating in the State, over which the 
EQRO exerts control or which exerts control over the EQRO (as used in 
this paragraph, ``control'' has the meaning given the term in 48 CFR 
19.101) through--
    (A) Stock ownership;
    (B) Stock options and convertible debentures;
    (C) Voting trusts;

[[Page 27885]]

    (D) Common management, including interlocking management; and
    (E) Contractual relationships.
    (ii) Deliver any health care services to Medicaid beneficiaries;
    (iii) Conduct, on the State's behalf, ongoing Medicaid managed care 
program operations related to oversight of the quality of MCO, PIHP, 
PAHP, or PCCM entity (described in Sec.  438.310(c)(2)) services, 
except for the related activities specified in Sec.  438.358;
    (iv) Review any MCO, PIHP, PAHP or PCCM entity (described in Sec.  
438.310(c)(2)) for which it is conducting or has conducted an 
accreditation review within the previous 3 years; or
    (v) Have a present, or known future, direct or indirect financial 
relationship with an MCO, PIHP, PAHP, or PCCM entity (described in 
Sec.  438.310(c)(2)) that it will review as an EQRO.


Sec.  438.356  State contract options for external quality review.

    (a) The State--
    (1) Must contract with one EQRO to conduct either EQR alone or EQR 
and other EQR-related activities.
    (2) May contract with additional EQROs or other entities to conduct 
EQR-related activities as set forth in Sec.  438.358.
    (b) Each EQRO must meet the competence requirements as specified in 
Sec.  438.354(b).
    (c) Each EQRO is permitted to use subcontractors. The EQRO is 
accountable for, and must oversee, all subcontractor functions.
    (d) Each EQRO and its subcontractors performing EQR or EQR-related 
activities must meet the requirements for independence, as specified in 
Sec.  438.354(c).
    (e) For each contract with an EQRO described in paragraph (a) of 
this section, the State must follow an open, competitive procurement 
process that is in accordance with State law and regulations. In 
addition, the State must comply with 45 CFR part 75 as it applies to 
State procurement of Medicaid services.


Sec.  438.358  Activities related to external quality review.

    (a) General rule. (1) The State, its agent that is not an MCO, 
PIHP, PAHP, or PCCM entity (described in Sec.  438.310(c)(2)), or an 
EQRO may perform the mandatory and optional EQR-related activities in 
this section.
    (2) The data obtained from the mandatory and optional EQR-related 
activities in this section must be used for the annual EQR in Sec.  
438.350 and must include, at a minimum, the elements in Sec.  
438.364(a)(i) through (iv).
    (b) Mandatory activities. (1) For each MCO, PIHP, or PAHP the 
following EQR-related activities must be performed:
    (i) Validation of performance improvement projects required in 
accordance with Sec.  438.330(b)(1) that were underway during the 
preceding 12 months.
    (ii) Validation of MCO, PIHP, or PAHP performance measures required 
in accordance with Sec.  438.330(b)(2) or MCO, PIHP, or PAHP 
performance measures calculated by the State during the preceding 12 
months.
    (iii) A review, conducted within the previous 3-year period, to 
determine the MCO's, PIHP's, or PAHP's compliance with the standards 
set forth in subpart D of this part and the quality assessment and 
performance improvement requirements described in Sec.  438.330.
    (iv) Validation of MCO, PIHP, or PAHP network adequacy during the 
preceding 12 months to comply with requirements set forth in Sec.  
438.68 and, if the State enrolls Indians in the MCO, PIHP, or PAHP, 
Sec.  438.14(b)(1).
    (2) For each PCCM entity (described in Sec.  438.310(c)(2)), the 
EQR-related activities in paragraphs (b)(1)(ii) and (iii) of this 
section must be performed.
    (c) Optional activities. For each MCO, PIHP, PAHP, and PCCM entity 
(described in Sec.  438.310(c)(2)), the following activities may be 
performed by using information derived during the preceding 12 months:
    (1) Validation of encounter data reported by an MCO, PIHP, PAHP, or 
PCCM entity (described in Sec.  438.310(c)(2)).
    (2) Administration or validation of consumer or provider surveys of 
quality of care.
    (3) Calculation of performance measures in addition to those 
reported by an MCO, PIHP, PAHP, or PCCM entity (described in Sec.  
438.310(c)(2)) and validated by an EQRO in accordance with (b)(2) of 
this section.
    (4) Conduct of performance improvement projects in addition to 
those conducted by an MCO, PIHP, PAHP, or PCCM entity (described in 
Sec.  438.310(c)(2)) and validated by an EQRO in accordance with (b)(1) 
of this section.
    (5) Conduct of studies on quality that focus on a particular aspect 
of clinical or nonclinical services at a point in time.
    (6) Assist with the quality rating of MCOs, PIHPs, and PAHPs 
consistent with Sec.  438.334.
    (d) Technical assistance. The EQRO may, at the State's direction, 
provide technical guidance to groups of MCOs, PIHPs, PAHPs, or PCCM 
entities (described in Sec.  438.310(c)(2)) to assist them in 
conducting activities related to the mandatory and optional activities 
described in this section that provide information for the EQR and the 
resulting EQR technical report.


Sec.  438.360  Nonduplication of mandatory activities with Medicare or 
accreditation review.

    (a) General rule. Consistent with guidance issued by the Secretary 
under Sec.  438.352, to avoid duplication the State may use information 
from a Medicare or private accreditation review of an MCO, PIHP, or 
PAHP to provide information for the annual EQR (described in Sec.  
438.350) instead of conducting one or more of the EQR activities 
described in Sec.  438.358(b)(1)(i) through (iii) (relating to the 
validation of performance improvement projects, validation of 
performance measures, and compliance review) if the following 
conditions are met:
    (1) The MCO, PIHP, or PAHP is in compliance with the applicable 
Medicare Advantage standards established by CMS, as determined by CMS 
or its contractor for Medicare, or has obtained accreditation from a 
private accrediting organization recognized by CMS as applying 
standards at least as stringent as Medicare under the procedures in 
Sec.  422.158 of this chapter;
    (2) The Medicare or private accreditation review standards are 
comparable to standards established through the EQR protocols (Sec.  
438.352) for the EQR activities described in Sec.  438.358(b)(1)(i) 
through (iii); and
    (3) The MCO, PIHP, or PAHP provides to the State all the reports, 
findings, and other results of the Medicare or private accreditation 
review activities applicable to the standards for the EQR activities.
    (b) External quality review report. If the State uses information 
from a Medicare or private accreditation review in accordance with 
paragraph (a) of this section, the State must ensure that all such 
information is furnished to the EQRO for analysis and inclusion in the 
report described in Sec.  438.364(a).
    (c) Quality strategy. The State must identify in its quality 
strategy under Sec.  438.340 the EQR activities for which it has 
exercised the option described in this section, and explain the 
rationale for the State's determination that the Medicare review or 
private accreditation activity is comparable to such EQR activities, 
consistent with paragraph (a)(2) of this section.

[[Page 27886]]

Sec.  438.362  Exemption from external quality review.

    (a) Basis for exemption. The State may exempt an MCO from EQR if 
the following conditions are met:
    (1) The MCO has a current Medicare contract under part C of Title 
XVIII or under section 1876 of the Act, and a current Medicaid contract 
under section 1903(m) of the Act.
    (2) The two contracts cover all or part of the same geographic area 
within the State.
    (3) The Medicaid contract has been in effect for at least 2 
consecutive years before the effective date of the exemption and during 
those 2 years the MCO has been subject to EQR under this part, and 
found to be performing acceptably for the quality, timeliness, and 
access to health care services it provides to Medicaid beneficiaries.
    (b) Information on exempted MCOs. When the State exercises this 
option, the State must obtain either of the following:
    (1) Information on Medicare review findings. Each year, the State 
must obtain from each MCO that it exempts from EQR the most recent 
Medicare review findings reported on the MCO including--
    (i) All data, correspondence, information, and findings pertaining 
to the MCO's compliance with Medicare standards for access, quality 
assessment and performance improvement, health services, or delegation 
of these activities.
    (ii) All measures of the MCO's performance.
    (iii) The findings and results of all performance improvement 
projects pertaining to Medicare enrollees.
    (2) Medicare information from a private, national accrediting 
organization that CMS approves and recognizes for Medicare Advantage 
Organization deeming. (i) If an exempted MCO has been reviewed by a 
private accrediting organization, the State must require the MCO to 
provide the State with a copy of all findings pertaining to its most 
recent accreditation review if that review has been used for either of 
the following purposes:
    (A) To fulfill certain requirements for Medicare external review 
under subpart D of part 422 of this chapter.
    (B) To deem compliance with Medicare requirements, as provided in 
Sec.  422.156 of this chapter.
    (ii) These findings must include, but need not be limited to, 
accreditation review results of evaluation of compliance with 
individual accreditation standards, noted deficiencies, corrective 
action plans, and summaries of unmet accreditation requirements.


Sec.  438.364  External quality review results.

    (a) Information that must be produced. The State must ensure that 
the EQR results in an annual detailed technical report that summarizes 
findings on access and quality of care, including:
    (1) A description of the manner in which the data from all 
activities conducted in accordance with Sec.  438.358 were aggregated 
and analyzed, and conclusions were drawn as to the quality, timeliness, 
and access to the care furnished by the MCO, PIHP, PAHP, or PCCM entity 
(described in Sec.  438.310(c)(2)).
    (2) For each EQR-related activity conducted in accordance with 
Sec.  438.358:
    (i) Objectives;
    (ii) Technical methods of data collection and analysis;
    (iii) Description of data obtained, including validated performance 
measurement data for each activity conducted in accordance with Sec.  
438.358(b)(1)(i) and (ii); and
    (iv) Conclusions drawn from the data.
    (3) An assessment of each MCO's, PIHP's, PAHP's, or PCCM entity's 
(described in Sec.  438.310(c)(2)) strengths and weaknesses for the 
quality, timeliness, and access to health care services furnished to 
Medicaid beneficiaries.
    (4) Recommendations for improving the quality of health care 
services furnished by each MCO, PIHP, PAHP, or PCCM entity (described 
in Sec.  438.310(c)(2)) including how the State can target goals and 
objectives in the quality strategy, under Sec.  438.340, to better 
support improvement in the quality, timeliness, and access to health 
care services furnished to Medicaid beneficiaries.
    (5) Methodologically appropriate, comparative information about all 
MCOs, PIHPs, PAHPs, and PCCM entities (described in Sec.  
438.310(c)(2)), consistent with guidance included in the EQR protocols 
issued in accordance with Sec.  438.352(e).
    (6) An assessment of the degree to which each MCO, PIHP, PAHP, or 
PCCM entity (described in Sec.  438.310(c)(2)) has addressed 
effectively the recommendations for quality improvement made by the 
EQRO during the previous year's EQR.
    (b) Revision. States may not substantively revise the content of 
the final EQR technical report without evidence of error or omission.
    (c) Availability of information. (1) The State must contract with a 
qualified EQRO to produce and submit to the State an annual EQR 
technical report in accordance with paragraph (a) of this section. The 
State must finalize the annual technical report by April 30th of each 
year.
    (2) The State must--
    (i) Post the most recent copy of the annual EQR technical report on 
the Web site required under Sec.  438.10(c)(3) by April 30th of each 
year.
    (ii) Provide printed or electronic copies of the information 
specified in paragraph (a) of this section, upon request, to interested 
parties such as participating health care providers, enrollees and 
potential enrollees of the MCO, PIHP, PAHP, or PCCM entity (described 
in Sec.  438.310(c)(2)), beneficiary advocacy groups, and members of 
the general public.
    (3) The State must make the information specified in paragraph (a) 
of this section available in alternative formats for persons with 
disabilities, when requested.
    (d) Safeguarding patient identity. The information released under 
paragraph (b) of this section may not disclose the identity or other 
protected health information of any patient.


Sec.  438.370  Federal financial participation (FFP).

    (a) FFP at the 75 percent rate is available in expenditures for EQR 
(including the production of EQR results) and the EQR-related 
activities set forth in Sec.  438.358 performed on MCOs and conducted 
by EQROs and their subcontractors.
    (b) FFP at the 50 percent rate is available in expenditures for 
EQR-related activities conducted by any entity that does not qualify as 
an EQRO, and for EQR (including the production of EQR results) and EQR-
related activities performed by an EQRO on entities other than MCOs.
    (c) Prior to claiming FFP at the 75 percent rate in accordance with 
paragraph (a) of this section, the State must submit each EQRO contract 
to CMS for review and approval.

Subpart F--Grievance and Appeal System


Sec.  438.400  Statutory basis, definitions, and applicability.

    (a) Statutory basis. This subpart is based on the following 
statutory sections:
    (1) Section 1902(a)(3) of the Act requires that a State plan 
provide an opportunity for a fair hearing to any person whose claim for 
assistance is denied or not acted upon promptly.
    (2) Section 1902(a)(4) of the Act requires that the State plan 
provide for

[[Page 27887]]

methods of administration that the Secretary finds necessary for the 
proper and efficient operation of the plan.
    (3) Section 1932(b)(4) of the Act requires Medicaid managed care 
organizations to establish internal grievance procedures under which 
Medicaid enrollees, or providers acting on their behalf, may challenge 
the denial of coverage of, or payment for, medical assistance.
    (b) Definitions. As used in this subpart, the following terms have 
the indicated meanings:
    Adverse benefit determination means, in the case of an MCO, PIHP, 
or PAHP, any of the following:
    (1) The denial or limited authorization of a requested service, 
including determinations based on the type or level of service, 
requirements for medical necessity, appropriateness, setting, or 
effectiveness of a covered benefit.
    (2) The reduction, suspension, or termination of a previously 
authorized service.
    (3) The denial, in whole or in part, of payment for a service.
    (4) The failure to provide services in a timely manner, as defined 
by the State.
    (5) The failure of an MCO, PIHP, or PAHP to act within the 
timeframes provided in Sec.  438.408(b)(1) and (2) regarding the 
standard resolution of grievances and appeals.
    (6) For a resident of a rural area with only one MCO, the denial of 
an enrollee's request to exercise his or her right, under Sec.  
438.52(b)(2)(ii), to obtain services outside the network.
    (7) The denial of an enrollee's request to dispute a financial 
liability, including cost sharing, copayments, premiums, deductibles, 
coinsurance, and other enrollee financial liabilities.
    Appeal means a review by an MCO, PIHP, or PAHP of an adverse 
benefit determination.
    Grievance means an expression of dissatisfaction about any matter 
other than an adverse benefit determination. Grievances may include, 
but are not limited to, the quality of care or services provided, and 
aspects of interpersonal relationships such as rudeness of a provider 
or employee, or failure to respect the enrollee's rights regardless of 
whether remedial action is requested. Grievance includes an enrollee's 
right to dispute an extension of time proposed by the MCO, PIHP or PAHP 
to make an authorization decision.
    Grievance and appeal system means the processes the MCO, PIHP, or 
PAHP implements to handle appeals of an adverse benefit determination 
and grievances, as well as the processes to collect and track 
information about them.
    State fair hearing means the process set forth in subpart E of part 
431 of this chapter.
    (c) Applicability. This subpart applies to the rating period for 
contracts with MCOs, PIHPs, and PAHPs beginning on or after July 1, 
2017. Until that applicability date, states, MCOs, PIHPs, and PAHPs are 
required to continue to comply with subpart F contained in the 42 CFR 
parts 430 to 481, edition revised as of October 1, 2015.


Sec.  438.402  General requirements.

    (a) The grievance and appeal system. Each MCO, PIHP, and PAHP must 
have a grievance and appeal system in place for enrollees. Non-
emergency medical transportation PAHPs, as defined in Sec.  438.9, are 
not subject to this subpart F.
    (b) Level of appeals. Each MCO, PIHP, and PAHP may have only one 
level of appeal for enrollees.
    (c) Filing requirements--(1) Authority to file. (i) An enrollee may 
file a grievance and request an appeal with the MCO, PIHP, or PAHP. An 
enrollee may request a State fair hearing after receiving notice under 
Sec.  438.408 that the adverse benefit determination is upheld.
    (A) Deemed exhaustion of appeals processes. In the case of an MCO, 
PIHP, or PAHP that fails to adhere to the notice and timing 
requirements in Sec.  438.408, the enrollee is deemed to have exhausted 
the MCO's, PIHP's, or PAHP's appeals process. The enrollee may initiate 
a State fair hearing.
    (B) External medical review. The State may offer and arrange for an 
external medical review if the following conditions are met.
    (1) The review must be at the enrollee's option and must not be 
required before or used as a deterrent to proceeding to the State fair 
hearing.
    (2) The review must be independent of both the State and MCO, PIHP, 
or PAHP.
    (3) The review must be offered without any cost to the enrollee.
    (4) The review must not extend any of the timeframes specified in 
Sec.  438.408 and must not disrupt the continuation of benefits in 
Sec.  438.420.
    (ii) If State law permits and with the written consent of the 
enrollee, a provider or an authorized representative may request an 
appeal or file a grievance, or request a State fair hearing, on behalf 
of an enrollee. When the term ``enrollee'' is used throughout subpart F 
of this part, it includes providers and authorized representatives 
consistent with this paragraph, with the exception that providers 
cannot request continuation of benefits as specified in Sec.  
438.420(b)(5).
    (2) Timing--(i) Grievance. An enrollee may file a grievance with 
the MCO, PIHP, or PAHP at any time.
    (ii) Appeal. Following receipt of a notification of an adverse 
benefit determination by an MCO, PIHP, or PAHP, an enrollee has 60 
calendar days from the date on the adverse benefit determination notice 
in which to file a request for an appeal to the managed care plan.
    (3) Procedures--(i) Grievance. The enrollee may file a grievance 
either orally or in writing and, as determined by the State, either 
with the State or with the MCO, PIHP, or PAHP.
    (ii) Appeal. The enrollee may request an appeal either orally or in 
writing. Further, unless the enrollee requests an expedited resolution, 
an oral appeal must be followed by a written, signed appeal.


Sec.  438.404  Timely and adequate notice of adverse benefit 
determination.

    (a) Notice. The MCO, PIHP, or PAHP must give enrollees timely and 
adequate notice of an adverse benefit determination in writing 
consistent with the requirements below and in Sec.  438.10.
    (b) Content of notice. The notice must explain the following:
    (1) The adverse benefit determination the MCO, PIHP, or PAHP has 
made or intends to make.
    (2) The reasons for the adverse benefit determination, including 
the right of the enrollee to be provided upon request and free of 
charge, reasonable access to and copies of all documents, records, and 
other information relevant to the enrollee's adverse benefit 
determination. Such information includes medical necessity criteria, 
and any processes, strategies, or evidentiary standards used in setting 
coverage limits.
    (3) The enrollee's right to request an appeal of the MCO's, PIHP's, 
or PAHP's adverse benefit determination, including information on 
exhausting the MCO's, PIHP's, or PAHP's one level of appeal described 
at Sec.  438.402(b) and the right to request a State fair hearing 
consistent with Sec.  438.402(c).
    (4) The procedures for exercising the rights specified in this 
paragraph (b).
    (5) The circumstances under which an appeal process can be 
expedited and how to request it.
    (6) The enrollee's right to have benefits continue pending 
resolution of the appeal, how to request that benefits be continued, 
and the circumstances, consistent with state policy, under which the 
enrollee may be required to pay the costs of these services.

[[Page 27888]]

    (c) Timing of notice. The MCO, PIHP, or PAHP must mail the notice 
within the following timeframes:
    (1) For termination, suspension, or reduction of previously 
authorized Medicaid-covered services, within the timeframes specified 
in Sec. Sec.  431.211, 431.213, and 431.214 of this chapter.
    (2) For denial of payment, at the time of any action affecting the 
claim.
    (3) For standard service authorization decisions that deny or limit 
services, within the timeframe specified in Sec.  438.210(d)(1).
    (4) If the MCO, PIHP, or PAHP meets the criteria set forth for 
extending the timeframe for standard service authorization decisions 
consistent with Sec.  438.210(d)(1)(ii), it must--
    (i) Give the enrollee written notice of the reason for the decision 
to extend the timeframe and inform the enrollee of the right to file a 
grievance if he or she disagrees with that decision; and
    (ii) Issue and carry out its determination as expeditiously as the 
enrollee's health condition requires and no later than the date the 
extension expires.
    (5) For service authorization decisions not reached within the 
timeframes specified in Sec.  438.210(d) (which constitutes a denial 
and is thus an adverse benefit determination), on the date that the 
timeframes expire.
    (6) For expedited service authorization decisions, within the 
timeframes specified in Sec.  438.210(d)(2).


Sec.  438.406  Handling of grievances and appeals.

    (a) General requirements. In handling grievances and appeals, each 
MCO, PIHP, and PAHP must give enrollees any reasonable assistance in 
completing forms and taking other procedural steps related to a 
grievance or appeal. This includes, but is not limited to, auxiliary 
aids and services upon request, such as providing interpreter services 
and toll-free numbers that have adequate TTY/TTD and interpreter 
capability.
    (b) Special requirements. An MCO's, PIHP's or PAHP's process for 
handling enrollee grievances and appeals of adverse benefit 
determinations must:
    (1) Acknowledge receipt of each grievance and appeal.
    (2) Ensure that the individuals who make decisions on grievances 
and appeals are individuals--
    (i) Who were neither involved in any previous level of review or 
decision-making nor a subordinate of any such individual.
    (ii) Who, if deciding any of the following, are individuals who 
have the appropriate clinical expertise, as determined by the State, in 
treating the enrollee's condition or disease.
    (A) An appeal of a denial that is based on lack of medical 
necessity.
    (B) A grievance regarding denial of expedited resolution of an 
appeal.
    (C) A grievance or appeal that involves clinical issues.
    (iii) Who take into account all comments, documents, records, and 
other information submitted by the enrollee or their representative 
without regard to whether such information was submitted or considered 
in the initial adverse benefit determination.
    (3) Provide that oral inquiries seeking to appeal an adverse 
benefit determination are treated as appeals (to establish the earliest 
possible filing date for the appeal) and must be confirmed in writing, 
unless the enrollee or the provider requests expedited resolution.
    (4) Provide the enrollee a reasonable opportunity, in person and in 
writing, to present evidence and testimony and make legal and factual 
arguments. The MCO, PIHP, or PAHP must inform the enrollee of the 
limited time available for this sufficiently in advance of the 
resolution timeframe for appeals as specified in Sec.  438.408(b) and 
(c) in the case of expedited resolution.
    (5) Provide the enrollee and his or her representative the 
enrollee's case file, including medical records, other documents and 
records, and any new or additional evidence considered, relied upon, or 
generated by the MCO, PIHP or PAHP (or at the direction of the MCO, 
PIHP or PAHP) in connection with the appeal of the adverse benefit 
determination. This information must be provided free of charge and 
sufficiently in advance of the resolution timeframe for appeals as 
specified in Sec.  438.408(b) and (c).
    (6) Include, as parties to the appeal--
    (i) The enrollee and his or her representative; or
    (ii) The legal representative of a deceased enrollee's estate.


Sec.  438.408  Resolution and notification: Grievances and appeals.

    (a) Basic rule. Each MCO, PIHP, or PAHP must resolve each grievance 
and appeal, and provide notice, as expeditiously as the enrollee's 
health condition requires, within State-established timeframes that may 
not exceed the timeframes specified in this section.
    (b) Specific timeframes--(1) Standard resolution of grievances. For 
standard resolution of a grievance and notice to the affected parties, 
the timeframe is established by the State but may not exceed 90 
calendar days from the day the MCO, PIHP, or PAHP receives the 
grievance.
    (2) Standard resolution of appeals. For standard resolution of an 
appeal and notice to the affected parties, the State must establish a 
timeframe that is no longer than 30 calendar days from the day the MCO, 
PIHP, or PAHP receives the appeal. This timeframe may be extended under 
paragraph (c) of this section.
    (3) Expedited resolution of appeals. For expedited resolution of an 
appeal and notice to affected parties, the State must establish a 
timeframe that is no longer than 72 hours after the MCO, PIHP, or PAHP 
receives the appeal. This timeframe may be extended under paragraph (c) 
of this section.
    (c) Extension of timeframes. (1) The MCO, PIHP, or PAHP may extend 
the timeframes from paragraph (b) of this section by up to 14 calendar 
days if--
    (i) The enrollee requests the extension; or
    (ii) The MCO, PIHP, or PAHP shows (to the satisfaction of the State 
agency, upon its request) that there is need for additional information 
and how the delay is in the enrollee's interest.
    (2) Requirements following extension. If the MCO, PIHP, or PAHP 
extends the timeframes not at the request of the enrollee, it must 
complete all of the following:
    (i) Make reasonable efforts to give the enrollee prompt oral notice 
of the delay.
    (ii) Within 2 calendar days give the enrollee written notice of the 
reason for the decision to extend the timeframe and inform the enrollee 
of the right to file a grievance if he or she disagrees with that 
decision.
    (iii) Resolve the appeal as expeditiously as the enrollee's health 
condition requires and no later than the date the extension expires.
    (3) Deemed exhaustion of appeals processes. In the case of an MCO, 
PIHP, or PAHP that fails to adhere to the notice and timing 
requirements in this section, the enrollee is deemed to have exhausted 
the MCO's, PIHP's, or PAHP's appeals process. The enrollee may initiate 
a State fair hearing.
    (d) Format of notice--(1) Grievances. The State must establish the 
method that an MCO, PIHP, and PAHP will use to notify an enrollee of 
the resolution of a grievance and ensure that such methods meet, at a 
minimum, the standards described at Sec.  438.10.
    (2) Appeals. (i) For all appeals, the MCO, PIHP, or PAHP must 
provide written notice of resolution in a format and language that, at 
a minimum, meet the standards described at Sec.  438.10.
    (ii) For notice of an expedited resolution, the MCO, PIHP, or PAHP 
must also make reasonable efforts to provide oral notice.

[[Page 27889]]

    (e) Content of notice of appeal resolution. The written notice of 
the resolution must include the following:
    (1) The results of the resolution process and the date it was 
completed.
    (2) For appeals not resolved wholly in favor of the enrollees--
    (i) The right to request a State fair hearing, and how to do so.
    (ii) The right to request and receive benefits while the hearing is 
pending, and how to make the request.
    (iii) That the enrollee may, consistent with state policy, be held 
liable for the cost of those benefits if the hearing decision upholds 
the MCO's, PIHP's, or PAHP's adverse benefit determination.
    (f) Requirements for State fair hearings--(1) Availability. An 
enrollee may request a State fair hearing only after receiving notice 
that the MCO, PIHP, or PAHP is upholding the adverse benefit 
determination.
    (i) Deemed exhaustion of appeals processes. In the case of an MCO, 
PIHP, or PAHP that fails to adhere to the notice and timing 
requirements in Sec.  438.408, the enrollee is deemed to have exhausted 
the MCO's, PIHP's, or PAHP's appeals process. The enrollee may initiate 
a State fair hearing.
    (ii) External medical review. The State may offer and arrange for 
an external medical review if the following conditions are met.
    (A) The review must be at the enrollee's option and must not be 
required before or used as a deterrent to proceeding to the State fair 
hearing.
    (B) The review must be independent of both the State and MCO, PIHP, 
or PAHP.
    (C) The review must be offered without any cost to the enrollee.
    (D) The review must not extend any of the timeframes specified in 
Sec.  438.408 and must not disrupt the continuation of benefits in 
Sec.  438.420.
    (2) State fair hearing. The enrollee must request a State fair 
hearing no later than 120 calendar days from the date of the MCO's, 
PIHP's, or PAHP's notice of resolution.
    (3) Parties. The parties to the State fair hearing include the MCO, 
PIHP, or PAHP, as well as the enrollee and his or her representative or 
the representative of a deceased enrollee's estate.


Sec.  438.410  Expedited resolution of appeals.

    (a) General rule. Each MCO, PIHP, and PAHP must establish and 
maintain an expedited review process for appeals, when the MCO, PIHP, 
or PAHP determines (for a request from the enrollee) or the provider 
indicates (in making the request on the enrollee's behalf or supporting 
the enrollee's request) that taking the time for a standard resolution 
could seriously jeopardize the enrollee's life, physical or mental 
health, or ability to attain, maintain, or regain maximum function.
    (b) Punitive action. The MCO, PIHP, or PAHP must ensure that 
punitive action is not taken against a provider who requests an 
expedited resolution or supports an enrollee's appeal.
    (c) Action following denial of a request for expedited resolution. 
If the MCO, PIHP, or PAHP denies a request for expedited resolution of 
an appeal, it must--
    (1) Transfer the appeal to the timeframe for standard resolution in 
accordance with Sec.  438.408(b)(2).
    (2) Follow the requirements in Sec.  438.408(c)(2).


Sec.  438.414  Information about the grievance and appeal system to 
providers and subcontractors.

    The MCO, PIHP, or PAHP must provide information specified in Sec.  
438.10(g)(2)(xi) about the grievance and appeal system to all providers 
and subcontractors at the time they enter into a contract.


Sec.  438.416  Recordkeeping requirements.

    (a) The State must require MCOs, PIHPs, and PAHPs to maintain 
records of grievances and appeals and must review the information as 
part of its ongoing monitoring procedures, as well as for updates and 
revisions to the State quality strategy.
    (b) The record of each grievance or appeal must contain, at a 
minimum, all of the following information:
    (1) A general description of the reason for the appeal or 
grievance.
    (2) The date received.
    (3) The date of each review or, if applicable, review meeting.
    (4) Resolution at each level of the appeal or grievance, if 
applicable.
    (5) Date of resolution at each level, if applicable.
    (6) Name of the covered person for whom the appeal or grievance was 
filed.
    (c) The record must be accurately maintained in a manner accessible 
to the state and available upon request to CMS.


Sec.  438.420  Continuation of benefits while the MCO, PIHP, or PAHP 
appeal and the State fair hearing are pending.

    (a) Definition. As used in this section--
    Timely files means files for continuation of benefits on or before 
the later of the following:
    (i) Within 10 calendar days of the MCO, PIHP, or PAHP sending the 
notice of adverse benefit determination.
    (ii) The intended effective date of the MCO's, PIHP's, or PAHP's 
proposed adverse benefit determination.
    (b) Continuation of benefits. The MCO, PIHP, or PAHP must continue 
the enrollee's benefits if all of the following occur:
    (1) The enrollee files the request for an appeal timely in 
accordance with Sec.  438.402(c)(1)(ii) and (c)(2)(ii);
    (2) The appeal involves the termination, suspension, or reduction 
of previously authorized services;
    (3) The services were ordered by an authorized provider;
    (4) The period covered by the original authorization has not 
expired; and
    (5) The enrollee timely files for continuation of benefits.
    (c) Duration of continued or reinstated benefits. If, at the 
enrollee's request, the MCO, PIHP, or PAHP continues or reinstates the 
enrollee's benefits while the appeal or state fair hearing is pending, 
the benefits must be continued until one of following occurs:
    (1) The enrollee withdraws the appeal or request for state fair 
hearing.
    (2) The enrollee fails to request a state fair hearing and 
continuation of benefits within 10 calendar days after the MCO, PIHP, 
or PAHP sends the notice of an adverse resolution to the enrollee's 
appeal under Sec.  438.408(d)(2).
    (3) A State fair hearing office issues a hearing decision adverse 
to the enrollee.
    (d) Enrollee responsibility for services furnished while the appeal 
or state fair hearing is pending. If the final resolution of the appeal 
or state fair hearing is adverse to the enrollee, that is, upholds the 
MCO's, PIHP's, or PAHP's adverse benefit determination, the MCO, PIHP, 
or PAHP may, consistent with the state's usual policy on recoveries 
under Sec.  431.230(b) of this chapter and as specified in the MCO's, 
PIHP's, or PAHP's contract, recover the cost of services furnished to 
the enrollee while the appeal and state fair hearing was pending, to 
the extent that they were furnished solely because of the requirements 
of this section.


Sec.  438.424  Effectuation of reversed appeal resolutions.

    (a) Services not furnished while the appeal is pending. If the MCO, 
PIHP, or PAHP, or the State fair hearing officer reverses a decision to 
deny, limit, or delay services that were not furnished while the appeal 
was pending, the MCO, PIHP, or PAHP must authorize or provide the 
disputed services promptly and as expeditiously as the enrollee's 
health condition requires but no later than 72 hours from the date it 
receives notice reversing the determination.
    (b) Services furnished while the appeal is pending. If the MCO, 
PIHP, or PAHP, or the State fair hearing officer reverses a decision to 
deny

[[Page 27890]]

authorization of services, and the enrollee received the disputed 
services while the appeal was pending, the MCO, PIHP, or PAHP, or the 
State must pay for those services, in accordance with State policy and 
regulations.

Subpart G--[Reserved]

Subpart H--Additional Program Integrity Safeguards


Sec.  438.600  Statutory basis, basic rule, and applicability.

    (a) Statutory basis. This subpart is based on the following 
statutory sections:
    (1) Section 1128 of the Act provides for the exclusion of certain 
individuals and entities from participation in the Medicaid program.
    (2) Section 1128J(d) of the Act requires that persons who have 
received an overpayment under Medicaid report and return the 
overpayment within 60 days after the date on which the overpayment was 
identified.
    (3) Section 1902(a)(4) of the Act requires that the State plan 
provide for methods of administration that the Secretary finds 
necessary for the proper and efficient operation of the plan.
    (4) Section 1902(a)(19) of the Act requires that the State plan 
provide the safeguards necessary to ensure that eligibility is 
determined and services are provided in a manner consistent with 
simplicity of administration and the best interests of the 
beneficiaries.
    (5) Section 1902(a)(27) of the Act requires States to enroll 
persons or institutions that provide services under the State plan.
    (6) Section 1902(a)(68) of the Act requires that any entity that 
receives or makes annual payments under the State plan of at least 
$5,000,000 must establish certain minimum written policies relating to 
the Federal False Claims Act.
    (7) Section 1902(a)(77) of the Act requires that States comply with 
provider and supplier screening, oversight, and reporting requirements 
described in section 1902(kk)(1) of the Act.
    (8) Section 1902(a)(80) of the Act prohibits payments for items or 
services provided under the State plan or under a waiver to any 
financial institution or entity located outside of the United States.
    (9) Section 1902(kk)(7) of the Act requires States to enroll 
physicians or other professionals that order or refer services under 
the State plan.
    (10) Section 1903(i) of the Act prohibits FFP for amounts expended 
by MCOs or PCCMs for providers excluded by Medicare, Medicaid, or CHIP, 
except for emergency services.
    (11) Section 1903(m) of the Act establishes conditions for payments 
to the State for contracts with MCOs.
    (12) Section 1932(d)(1) of the Act prohibits MCOs and PCCMs from 
knowingly having certain types of relationships with individuals and 
entities debarred under Federal regulations from participating in 
specified activities, or with affiliates of those individuals.
    (b) Basic rule. As a condition for receiving payment under a 
Medicaid managed care program, an MCO, PIHP, PAHP, PCCM or PCCM entity 
must comply with the requirements in Sec. Sec.  438.604, 438.606, 
438.608 and 438.610, as applicable.
    (c) Applicability. States will not be held out compliance with the 
following requirements of this subpart prior to the dates noted below 
so long as they comply with the corresponding standard(s) in 42 CFR 
part 438 contained in the CFR, parts 430 to 481, edition revised as of 
October 1, 2015:
    (1) States must comply with Sec. Sec.  438.602(a), 438.602(c) 
through (h), 438.604, 438.606, 438.608(a), and 438.608(c) and (d), no 
later than the rating period for contracts starting on or after July 1, 
2017.
    (2) States must comply with Sec.  438.602(b) and Sec.  438.608(b) 
no later than the rating period for contracts beginning on or after 
July 1, 2018.


Sec.  438.602  State responsibilities.

    (a) Monitoring contractor compliance. Consistent with Sec.  438.66, 
the State must monitor the MCO's, PIHP's, PAHP's, PCCM's or PCCM 
entity's compliance, as applicable, with Sec. Sec.  438.604, 438.606, 
438.608, 438.610, 438.230, and 438.808.
    (b) Screening and enrollment and revalidation of providers. (1) The 
State must screen and enroll, and periodically revalidate, all network 
providers of MCOs, PIHPs, and PAHPs, in accordance with the 
requirements of part 455, subparts B and E of this chapter. This 
requirement extends to PCCMs and PCCM entities to the extent the 
primary care case manager is not otherwise enrolled with the State to 
provide services to FFS beneficiaries. This provision does not require 
the network provider to render services to FFS beneficiaries.
    (2) MCOs, PIHPs, and PAHPs may execute network provider agreements 
pending the outcome of the process in paragraph (b)(1) of this section 
of up to 120 days, but must terminate a network provider immediately 
upon notification from the State that the network provider cannot be 
enrolled, or the expiration of one 120 day period without enrollment of 
the provider, and notify affected enrollees.
    (c) Ownership and control information. The State must review the 
ownership and control disclosures submitted by the MCO, PIHP, PAHP, 
PCCM or PCCM entity, and any subcontractors as required in Sec.  
438.608(c).
    (d) Federal database checks. Consistent with the requirements at 
Sec.  455.436 of this chapter, the State must confirm the identity and 
determine the exclusion status of the MCO, PIHP, PAHP, PCCM or PCCM 
entity, any subcontractor, as well as any person with an ownership or 
control interest, or who is an agent or managing employee of the MCO, 
PIHP, PAHP, PCCM or PCCM entity through routine checks of Federal 
databases. This includes the Social Security Administration's Death 
Master File, the National Plan and Provider Enumeration System (NPPES), 
the List of Excluded Individuals/Entities (LEIE), the System for Award 
Management (SAM), and any other databases as the State or Secretary may 
prescribe. These databases must be consulted upon contracting and no 
less frequently than monthly thereafter. If the State finds a party 
that is excluded, it must promptly notify the MCO, PIHP, PAHP, PCCM, or 
PCCM entity and take action consistent with Sec.  438.610(c).
    (e) Periodic audits. The State must periodically, but no less 
frequently than once every 3 years, conduct, or contract for the 
conduct of, an independent audit of the accuracy, truthfulness, and 
completeness of the encounter and financial data submitted by, or on 
behalf of, each MCO, PIHP or PAHP.
    (f) Whistleblowers. The State must receive and investigate 
information from whistleblowers relating to the integrity of the MCO, 
PIHP, PAHP, PCCM, or PCCM entity, subcontractors, or network providers 
receiving Federal funds under this part.
    (g) Transparency. The State must post on its Web site, as required 
in Sec.  438.10(c)(3), the following documents and reports:
    (1) The MCO, PIHP, PAHP, or PCCM entity contract.
    (2) The data at Sec.  438.604(a)(5).
    (3) The name and title of individuals included in Sec.  
438.604(a)(6).
    (4) The results of any audits under paragraph (e) of this section.
    (h) Contracting integrity. The State must have in place conflict of 
interest safeguards described in Sec.  438.58 and must comply with the 
requirement described in section 1902(a)(4)(C) of the Act applicable to 
contracting officers, employees, or independent contractors.

[[Page 27891]]

    (i) Entities located outside of the U.S. The State must ensure that 
the MCO, PIHP, PAHP, PCCM, or PCCM entity with which the State 
contracts under this part is not located outside of the United States 
and that no claims paid by an MCO, PIHP, or PAHP to a network provider, 
out-of-network provider, subcontractor or financial institution located 
outside of the U.S. are considered in the development of actuarially 
sound capitation rates.


Sec.  438.604  Data, information, and documentation that must be 
submitted.

    (a) Specified data, information, and documentation. The State must 
require any MCO, PIHP, PAHP, PCCM or PCCM entity to submit to the State 
the following data:
    (1) Encounter data in the form and manner described in Sec.  
438.818.
    (2) Data on the basis of which the State certifies the actuarial 
soundness of capitation rates to an MCO, PIHP or PAHP under Sec.  
438.3, including base data described in Sec.  438.5(c) that is 
generated by the MCO, PIHP or PAHP.
    (3) Data on the basis of which the State determines the compliance 
of the MCO, PIHP, or PAHP with the medical loss ratio requirement 
described in Sec.  438.8.
    (4) Data on the basis of which the State determines that the MCO, 
PIHP or PAHP has made adequate provision against the risk of insolvency 
as required under Sec.  438.116.
    (5) Documentation described in Sec.  438.207(b) on which the State 
bases its certification that the MCO, PIHP or PAHP has complied with 
the State's requirements for availability and accessibility of 
services, including the adequacy of the provider network, as set forth 
in Sec.  438.206.
    (6) Information on ownership and control described in Sec.  455.104 
of this chapter from MCOs, PIHPs, PAHPs, PCCMs, PCCM entities, and 
subcontractors as governed by Sec.  438.230.
    (7) The annual report of overpayment recoveries as required in 
Sec.  438.608(d)(3).
    (b) Additional data, documentation, or information. In addition to 
the data, documentation, or information specified in paragraph (a) of 
this section, an MCO, PIHP, PAHP, PCCM or PCCM entity must submit any 
other data, documentation, or information relating to the performance 
of the entity's obligations under this part required by the State or 
the Secretary.


Sec.  438.606  Source, content, and timing of certification.

    (a) Source of certification. For the data, documentation, or 
information specified in Sec.  438.604, the State must require that the 
data, documentation or information the MCO, PIHP, PAHP, PCCM or PCCM 
entity submits to the State be certified by either the MCO's, PIHP's, 
PAHP's, PCCM's, or PCCM entity's Chief Executive Officer; Chief 
Financial Officer; or an individual who reports directly to the Chief 
Executive Officer or Chief Financial Officer with delegated authority 
to sign for the Chief Executive Officer or Chief Financial Officer so 
that the Chief Executive Officer or Chief Financial Officer is 
ultimately responsible for the certification.
    (b) Content of certification. The certification provided by the 
individual in paragraph (a) of this section must attest that, based on 
best information, knowledge, and belief, the data, documentation, and 
information specified in Sec.  438.604 is accurate, complete, and 
truthful.
    (c) Timing of certification. The State must require the MCO, PIHP, 
PAHP, PCCM, or PCCM entity to submit the certification concurrently 
with the submission of the data, documentation, or information required 
in Sec.  438.604(a) and (b).


Sec.  438.608  Program integrity requirements under the contract.

    (a) Administrative and management arrangements or procedures to 
detect and prevent fraud, waste and abuse. The State, through its 
contract with the MCO, PIHP or PAHP, must require that the MCO, PIHP, 
or PAHP, or subcontractor to the extent that the subcontractor is 
delegated responsibility by the MCO, PIHP, or PAHP for coverage of 
services and payment of claims under the contract between the State and 
the MCO, PIHP, or PAHP, implement and maintain arrangements or 
procedures that are designed to detect and prevent fraud, waste, and 
abuse. The arrangements or procedures must include the following:
    (1) A compliance program that includes, at a minimum, all of the 
following elements:
    (i) Written policies, procedures, and standards of conduct that 
articulate the organization's commitment to comply with all applicable 
requirements and standards under the contract, and all applicable 
Federal and State requirements.
    (ii) The designation of a Compliance Officer who is responsible for 
developing and implementing policies, procedures, and practices 
designed to ensure compliance with the requirements of the contract and 
who reports directly to the Chief Executive Officer and the board of 
directors.
    (iii) The establishment of a Regulatory Compliance Committee on the 
Board of Directors and at the senior management level charged with 
overseeing the organization's compliance program and its compliance 
with the requirements under the contract.
    (iv) A system for training and education for the Compliance 
Officer, the organization's senior management, and the organization's 
employees for the Federal and State standards and requirements under 
the contract.
    (v) Effective lines of communication between the compliance officer 
and the organization's employees.
    (vi) Enforcement of standards through well-publicized disciplinary 
guidelines.
    (vii) Establishment and implementation of procedures and a system 
with dedicated staff for routine internal monitoring and auditing of 
compliance risks, prompt response to compliance issues as they are 
raised, investigation of potential compliance problems as identified in 
the course of self-evaluation and audits, correction of such problems 
promptly and thoroughly (or coordination of suspected criminal acts 
with law enforcement agencies) to reduce the potential for recurrence, 
and ongoing compliance with the requirements under the contract.
    (2) Provision for prompt reporting of all overpayments identified 
or recovered, specifying the overpayments due to potential fraud, to 
the State.
    (3) Provision for prompt notification to the State when it receives 
information about changes in an enrollee's circumstances that may 
affect the enrollee's eligibility including all of the following:
    (i) Changes in the enrollee's residence;
    (ii) The death of an enrollee.
    (4) Provision for notification to the State when it receives 
information about a change in a network provider's circumstances that 
may affect the network provider's eligibility to participate in the 
managed care program, including the termination of the provider 
agreement with the MCO, PIHP or PAHP.
    (5) Provision for a method to verify, by sampling or other methods, 
whether services that have been represented to have been delivered by 
network providers were received by enrollees and the application of 
such verification processes on a regular basis.
    (6) In the case of MCOs, PIHPs, or PAHPs that make or receive 
annual payments under the contract of at least $5,000,000, provision 
for written policies for all employees of the entity, and of any 
contractor or agent, that provide detailed information about the

[[Page 27892]]

False Claims Act and other Federal and State laws described in section 
1902(a)(68) of the Act, including information about rights of employees 
to be protected as whistleblowers.
    (7) Provision for the prompt referral of any potential fraud, 
waste, or abuse that the MCO, PIHP, or PAHP identifies to the State 
Medicaid program integrity unit or any potential fraud directly to the 
State Medicaid Fraud Control Unit.
    (8) Provision for the MCO's, PIHP's, or PAHP's suspension of 
payments to a network provider for which the State determines there is 
a credible allegation of fraud in accordance with Sec.  455.23 of this 
chapter.
    (b) Provider screening and enrollment requirements. The State, 
through its contracts with a MCO, PIHP, PAHP, PCCM, or PCCM entity must 
ensure that all network providers are enrolled with the State as 
Medicaid providers consistent with the provider disclosure, screening 
and enrollment requirements of part 455, subparts B and E of this 
chapter. This provision does not require the network provider to render 
services to FFS beneficiaries.
    (c) Disclosures. The State must ensure, through its contracts, that 
each MCO, PIHP, PAHP, PCCM, PCCM entity, and any subcontractors:
    (1) Provides written disclosure of any prohibited affiliation under 
Sec.  438.610.
    (2) Provides written disclosures of information on ownership and 
control required under Sec.  455.104 of this chapter.
    (3) Reports to the State within 60 calendar days when it has 
identified the capitation payments or other payments in excess of 
amounts specified in the contract.
    (d) Treatment of recoveries made by the MCO, PIHP or PAHP of 
overpayments to providers. (1) Contracts with a MCO, PIHP, or PAHP must 
specify:
    (i) The retention policies for the treatment of recoveries of all 
overpayments from the MCO, PIHP, or PAHP to a provider, including 
specifically the retention policies for the treatment of recoveries of 
overpayments due to fraud, waste, or abuse.
    (ii) The process, timeframes, and documentation required for 
reporting the recovery of all overpayments.
    (iii) The process, timeframes, and documentation required for 
payment of recoveries of overpayments to the State in situations where 
the MCO, PIHP, or PAHP is not permitted to retain some or all of the 
recoveries of overpayments.
    (iv) This provision does not apply to any amount of a recovery to 
be retained under False Claims Act cases or through other 
investigations.
    (2) Each MCO, PIHP, or PAHP requires and has a mechanism for a 
network provider to report to the MCO, PIHP or PAHP when it has 
received an overpayment, to return the overpayment to the MCO, PIHP or 
PAHP within 60 calendar days after the date on which the overpayment 
was identified, and to notify the MCO, PIHP or PAHP in writing of the 
reason for the overpayment.
    (3) Each MCO, PIHP, or PAHP must report annually to the State on 
their recoveries of overpayments.
    (4) The State must use the results of the information and 
documentation collected in paragraph (d)(1) of this section and the 
report in paragraph (d)(3) of this section for setting actuarially 
sound capitation rates for each MCO, PIHP, or PAHP consistent with the 
requirements in Sec.  438.4.


Sec.  438.610  Prohibited affiliations.

    (a) An MCO, PIHP, PAHP, PCCM, or PCCM entity may not knowingly have 
a relationship of the type described in paragraph (c) of this section 
with the following:
    (1) An individual or entity that is debarred, suspended, or 
otherwise excluded from participating in procurement activities under 
the Federal Acquisition Regulation or from participating in 
nonprocurement activities under regulations issued under Executive 
Order No. 12549 or under guidelines implementing Executive Order No. 
12549.
    (2) An individual or entity who is an affiliate, as defined in the 
Federal Acquisition Regulation at 48 CFR 2.101, of a person described 
in paragraph (a)(1) of this section.
    (b) An MCO, PIHP, PAHP, PCCM, or PCCM entity may not have a 
relationship with an individual or entity that is excluded from 
participation in any Federal health care program under section 1128 or 
1128A of the Act.
    (c) The relationships described in paragraph (a) of this section, 
are as follows:
    (1) A director, officer, or partner of the MCO, PIHP, PAHP, PCCM. 
or PCCM entity.
    (2) A subcontractor of the MCO, PIHP, PAHP, PCCM, or PCCM entity, 
as governed by Sec.  438.230.
    (3) A person with beneficial ownership of 5 percent or more of the 
MCO's, PIHP's, PAHP's, PCCM's, or PCCM entity's equity.
    (4) A network provider or person with an employment, consulting or 
other arrangement with the MCO, PIHP, PAHP, PCCM, or PCCM entity for 
the provision of items and services that are significant and material 
to the MCO's, PIHP's, PAHP's, PCCM's, or PCCM entity's obligations 
under its contract with the State.
    (d) If a State finds that an MCO, PIHP, PAHP, PCCM, or PCCM entity 
is not in compliance with paragraphs (a) and (b) of this section, the 
State:
    (1) Must notify the Secretary of the noncompliance.
    (2) May continue an existing agreement with the MCO, PIHP, PAHP, 
PCCM, or PCCM entity unless the Secretary directs otherwise.
    (3) May not renew or otherwise extend the duration of an existing 
agreement with the MCO, PIHP, PAHP, PCCM, or PCCM entity unless the 
Secretary provides to the State and to Congress a written statement 
describing compelling reasons that exist for renewing or extending the 
agreement despite the prohibited affiliations.
    (4) Nothing in this section must be construed to limit or otherwise 
affect any remedies available to the U.S. under sections 1128, 1128A or 
1128B of the Act.
    (e) Consultation with the Inspector General. Any action by the 
Secretary described in paragraphs (d)(2) or (3) of this section is 
taken in consultation with the Inspector General.

Subpart I--Sanctions


Sec.  438.700  Basis for imposition of sanctions.

    (a) Each State that contracts with an MCO must, and each State that 
contracts with a PCCM or PCCM entity may, establish intermediate 
sanctions (which may include those specified in Sec.  438.702) that it 
may impose if it makes any of the determinations specified in 
paragraphs (b) through (d) of this section. The State may base its 
determinations on findings from onsite surveys, enrollee or other 
complaints, financial status, or any other source.
    (b) A State determines that an MCO acts or fails to act as follows:
    (1) Fails substantially to provide medically necessary services 
that the MCO is required to provide, under law or under its contract 
with the State, to an enrollee covered under the contract.
    (2) Imposes on enrollees premiums or charges that are in excess of 
the premiums or charges permitted under the Medicaid program.
    (3) Acts to discriminate among enrollees on the basis of their 
health status or need for health care services. This includes 
termination of enrollment or refusal to reenroll a beneficiary, except 
as permitted under the Medicaid program, or any practice that would 
reasonably be expected to discourage enrollment by beneficiaries whose

[[Page 27893]]

medical condition or history indicates probable need for substantial 
future medical services.
    (4) Misrepresents or falsifies information that it furnishes to CMS 
or to the State.
    (5) Misrepresents or falsifies information that it furnishes to an 
enrollee, potential enrollee, or health care provider.
    (6) Fails to comply with the requirements for physician incentive 
plans, as set forth (for Medicare) in Sec. Sec.  422.208 and 422.210 of 
this chapter.
    (c) A State determines that an MCO, PCCM or PCCM entity has 
distributed directly, or indirectly through any agent or independent 
contractor, marketing materials that have not been approved by the 
State or that contain false or materially misleading information.
    (d) A State determines that--
    (1) An MCO has violated any of the other requirements of sections 
1903(m) or 1932 of the Act, or any implementing regulations.
    (2) A PCCM or PCCM entity has violated any of the other applicable 
requirements of sections 1932 or 1905(t)(3) of the Act, or any 
implementing regulations.
    (3) For any of the violations under paragraphs (d)(1) and (2) of 
this section, only the sanctions specified in Sec.  438.702(a)(3), (4), 
and (5) may be imposed.


Sec.  438.702  Types of intermediate sanctions.

    (a) The types of intermediate sanctions that a State may impose 
under this subpart include the following:
    (1) Civil money penalties in the amounts specified in Sec.  
438.704.
    (2) Appointment of temporary management for an MCO as provided in 
Sec.  438.706.
    (3) Granting enrollees the right to terminate enrollment without 
cause and notifying the affected enrollees of their right to disenroll.
    (4) Suspension of all new enrollment, including default enrollment, 
after the date the Secretary or the State notifies the MCO of a 
determination of a violation of any requirement under sections 1903(m) 
or 1932 of the Act.
    (5) Suspension of payment for beneficiaries enrolled after the 
effective date of the sanction and until CMS or the State is satisfied 
that the reason for imposition of the sanction no longer exists and is 
not likely to recur.
    (b) State agencies retain authority to impose additional sanctions 
under State statutes or State regulations that address areas of 
noncompliance specified in Sec.  438.700, as well as additional areas 
of noncompliance. Nothing in this subpart prevents State agencies from 
exercising that authority.


Sec.  438.704  Amounts of civil money penalties.

    (a) General rule. If the State imposes civil monetary penalties as 
provided under Sec.  438.702(a)(1), the maximum civil money penalty the 
State may impose varies depending on the nature of the MCO's, PCCM or 
PCCM entity's action or failure to act, as provided in this section.
    (b) Specific limits. (1) The limit is $25,000 for each 
determination under Sec.  438.700(b)(1), (5), (6), and (c).
    (2) The limit is $100,000 for each determination under Sec.  
438.700(b)(3) or (4).
    (3) The limit is $15,000 for each beneficiary the State determines 
was not enrolled because of a discriminatory practice under Sec.  
438.700(b)(3). (This is subject to the overall limit of $100,000 under 
paragraph (b)(2) of this section).
    (c) Specific amount. For premiums or charges in excess of the 
amounts permitted under the Medicaid program, the maximum amount of the 
penalty is $25,000 or double the amount of the excess charges, 
whichever is greater. The State must deduct from the penalty the amount 
of overcharge and return it to the affected enrollees.


Sec.  438.706  Special rules for temporary management.

    (a) Optional imposition of sanction. If the State imposes temporary 
management under Sec.  438.702(a)(2), the State may do so only if it 
finds (through onsite surveys, enrollee or other complaints, financial 
status, or any other source) any of the following:
    (1) There is continued egregious behavior by the MCO, including but 
not limited to behavior that is described in Sec.  438.700, or that is 
contrary to any requirements of sections 1903(m) and 1932 of the Act.
    (2) There is substantial risk to enrollees' health.
    (3) The sanction is necessary to ensure the health of the MCO's 
enrollees--
    (i) While improvements are made to remedy violations under Sec.  
438.700.
    (ii) Until there is an orderly termination or reorganization of the 
MCO.
    (b) Required imposition of sanction. The State must impose 
temporary management (regardless of any other sanction that may be 
imposed) if it finds that an MCO has repeatedly failed to meet 
substantive requirements in sections 1903(m) or 1932 of the Act, or 
this subpart. The State must also grant enrollees the right to 
terminate enrollment without cause, as described in Sec.  
438.702(a)(3), and must notify the affected enrollees of their right to 
terminate enrollment.
    (c) Hearing. The State may not delay imposition of temporary 
management to provide a hearing before imposing this sanction.
    (d) Duration of sanction. The State may not terminate temporary 
management until it determines that the MCO can ensure that the 
sanctioned behavior will not recur.


Sec.  438.708  Termination of an MCO, PCCM or PCCM entity contract.

    A State has the authority to terminate an MCO, PCCM or PCCM entity 
contract and enroll that entity's enrollees in other MCOs, PCCMs or 
PCCM entities, or provide their Medicaid benefits through other options 
included in the State plan, if the State determines that the MCO, PCCM 
or PCCM entity has failed to do either of the following:
    (a) Carry out the substantive terms of its contract.
    (b) Meet applicable requirements in sections 1932, 1903(m), and 
1905(t) of the Act.


Sec.  438.710  Notice of sanction and pre-termination hearing.

    (a) Notice of sanction. Except as provided in Sec.  438.706(c), 
before imposing any of the intermediate sanctions specified in this 
subpart, the State must give the affected entity timely written notice 
that explains the following:
    (1) The basis and nature of the sanction.
    (2) Any other appeal rights that the State elects to provide.
    (b) Pre-termination hearing--(1) General rule. Before terminating 
an MCO, PCCM or PCCM entity contract under Sec.  438.708, the State 
must provide the entity a pre-termination hearing.
    (2) Procedures. The State must do all of the following:
    (i) Give the MCO, PCCM or PCCM entity written notice of its intent 
to terminate, the reason for termination, and the time and place of the 
hearing.
    (ii) After the hearing, give the entity written notice of the 
decision affirming or reversing the proposed termination of the 
contract and, for an affirming decision, the effective date of 
termination.
    (iii) For an affirming decision, give enrollees of the MCO, PCCM or 
PCCM entity notice of the termination and information, consistent with 
Sec.  438.10, on their options for receiving Medicaid services 
following the effective date of termination.


Sec.  438.722  Disenrollment during termination hearing process.

    After a State notifies an MCO, PCCM or PCCM entity that it intends 
to

[[Page 27894]]

terminate the contract, the State may do the following:
    (a) Give the entity's enrollees written notice of the State's 
intent to terminate the contract.
    (b) Allow enrollees to disenroll immediately without cause.


Sec.  438.724  Notice to CMS.

    (a) The State must give CMS written notice whenever it imposes or 
lifts a sanction for one of the violations listed in Sec.  438.700.
    (b) The notice must adhere to all of the following requirements:
    (1) Be given no later than 30 days after the State imposes or lifts 
a sanction.
    (2) Specify the affected MCO, the kind of sanction, and the reason 
for the State's decision to impose or lift a sanction.


Sec.  438.726  State plan requirement.

    (a) The State plan must include a plan to monitor for violations 
that involve the actions and failures to act specified in this part and 
to implement the provisions of this part.
    (b) A contract with an MCO must provide that payments provided for 
under the contract will be denied for new enrollees when, and for so 
long as, payment for those enrollees is denied by CMS under Sec.  
438.730(e).


Sec.  438.730  Sanction by CMS: Special rules for MCOs.

    (a) Basis for sanction. A State may recommend that CMS impose the 
denial of payment sanction specified in paragraph (e) of this section 
on an MCO with a contract under this part if the agency determines that 
the MCO acts or fails to act as specified in Sec.  438.700(b)(1) 
through (6).
    (b) Effect of an agency determination. (1) The State's 
determination becomes CMS' determination for purposes of section 
1903(m)(5)(A) of the Act unless CMS reverses or modifies it within 15 
days.
    (2) When the State decides to recommend imposing the sanction 
described in paragraph (e) of this section, this recommendation becomes 
CMS' decision, for purposes of section 1903(m)(5)(B)(ii) of the Act, 
unless CMS rejects this recommendation within 15 days.
    (c) Notice of sanction. If the State's determination becomes CMS' 
determination under paragraph (b)(2) of this section, the State takes 
all of the following actions:
    (1) Gives the MCO written notice of the nature and basis of the 
proposed sanction.
    (2) Allows the MCO 15 days from the date it receives the notice to 
provide evidence that it has not acted or failed to act in the manner 
that is the basis for the recommended sanction.
    (3) May extend the initial 15-day period for an additional 15 days 
if--
    (i) The MCO submits a written request that includes a credible 
explanation of why it needs additional time.
    (ii) The request is received by CMS before the end of the initial 
period.
    (iii) CMS has not determined that the MCO's conduct poses a threat 
to an enrollee's health or safety.
    (d) Informal reconsideration. (1) If the MCO submits a timely 
response to the notice of sanction, the State--
    (i) Conducts an informal reconsideration that includes review of 
the evidence by a State agency official who did not participate in the 
original recommendation.
    (ii) Gives the MCO a concise written decision setting forth the 
factual and legal basis for the decision.
    (iii) Forwards the decision to CMS.
    (2) The State's decision under paragraph (d)(1)(ii) of this section 
becomes CMS' decision unless CMS reverses or modifies the decision 
within 15 days from date of receipt by CMS.
    (3) If CMS reverses or modifies the State decision, the agency 
sends the MCO a copy of CMS' decision.
    (e) Denial of payment. (1) CMS, based upon the recommendation of 
the agency, may deny payment to the State for new enrollees of the MCO 
under section 1903(m)(5)(B)(ii) of the Act in the following situations:
    (i) If a CMS determination that an MCO has acted or failed to act, 
as described in paragraphs (b)(1) through (6) of Sec.  438.700, is 
affirmed on review under paragraph (d) of this section.
    (ii) If the CMS determination is not timely contested by the MCO 
under paragraph (c) of this section.
    (2) Under Sec.  438.726(b), CMS' denial of payment for new 
enrollees automatically results in a denial of agency payments to the 
MCO for the same enrollees. (A new enrollee is an enrollee that applies 
for enrollment after the effective date in paragraph (f)(1) of this 
section.)
    (f) Effective date of sanction. (1) If the MCO does not seek 
reconsideration, a sanction is effective 15 days after the date the MCO 
is notified under paragraph (c) of this section of the decision to 
impose the sanction.
    (2) If the MCO seeks reconsideration, the following rules apply:
    (i) Except as specified in paragraph (d)(2) of this section, the 
sanction is effective on the date specified in CMS' reconsideration 
notice.
    (ii) If CMS, in consultation with the State, determines that the 
MCO's conduct poses a serious threat to an enrollee's health or safety, 
the sanction may be made effective earlier than the date of the 
agency's reconsideration decision under paragraph (d)(1)(ii) of this 
section.
    (g) CMS' role. (1) CMS retains the right to independently perform 
the functions assigned to the State under paragraphs (a) through (d) of 
this section.
    (2) At the same time that the State sends notice to the MCO under 
paragraph (c)(1) of this section, CMS forwards a copy of the notice to 
the OIG.
    (3) CMS conveys the determination described in paragraph (b) of 
this section to the OIG for consideration of possible imposition of 
civil money penalties under section 1903(m)(5)(A) of the Act and part 
1003 of this title. In accordance with the provisions of part 1003, the 
OIG may impose civil money penalties on the MCO in addition to, or in 
place of, the sanctions that may be imposed under this section.

Subpart J--Conditions for Federal Financial Participation (FFP)


Sec.  438.802  Basic requirements.

    FFP is available in expenditures for payments under an MCO contract 
only for the periods during which the contract--
    (a) Meets the requirements of this part; and
    (b) Is in effect.


Sec.  438.806  Prior approval.

    (a) Comprehensive risk contracts. FFP is available under a 
comprehensive risk contract only if all of the following apply:
    (1) CMS has confirmed that the contractor meets the definition of 
an MCO or is one of the entities described in paragraphs (b)(2) through 
(5) of Sec.  438.3.
    (2) The contract meets all the requirements of section 
1903(m)(2)(A) of the Act, the applicable requirements of section 1932 
of the Act, and the provisions of this part.
    (b) MCO contracts. Prior approval by CMS is a condition for FFP 
under any MCO contract that extends for less than one full year or that 
has a value equal to, or greater than, the following threshold amounts:
    (1) For 1998, the threshold is $1,000,000.
    (2) For subsequent years, the amount is increased by the percentage 
increase in the consumer price index for all urban consumers.
    (c) FFP is not available in an MCO contract that does not have 
prior approval from CMS under paragraph (b) of this section.

[[Page 27895]]

Sec.  438.808  Exclusion of entities.

    (a) General rule. FFP is available in payments under MCO contracts 
or PIHP, PAHP, PCCM, or PCCM entity contracts under a section 
1915(b)(1) of the Act waiver only if the State excludes from the 
contracts any entities described in paragraph (b) of this section.
    (b) Entities that must be excluded. (1) An entity that could be 
excluded under section 1128(b)(8) of the Act as being controlled by a 
sanctioned individual.
    (2) An entity that has a substantial contractual relationship as 
defined in Sec.  431.55(h)(3) of this chapter, either directly or 
indirectly, with an individual convicted of certain crimes as described 
in section 1128(b)(8)(B) of the Act or an individual described in Sec.  
438.610(a) and (b).
    (3) An entity that employs or contracts, directly or indirectly, 
for the furnishing of health care, utilization review, medical social 
work, or administrative services, with one of the following:
    (i) Any individual or entity described in Sec.  438.610(a) and (b).
    (ii) Any individual or entity that would provide those services 
through an individual or entity described in Sec.  438.610(a) and (b).


Sec.  438.810  Expenditures for enrollment broker services.

    (a) Definitions. As used in this section--
    Enrollment activities means activities such as distributing, 
collecting, and processing enrollment materials and taking enrollments 
by phone, in person, or through electronic methods of communication.
    Enrollment broker means an individual or entity that performs 
choice counseling or enrollment activities, or both.
    Enrollment services means choice counseling, or enrollment 
activities, or both.
    (b) Conditions that enrollment brokers must meet. State 
expenditures for the use of enrollment brokers are considered necessary 
for the proper and efficient operation of the State plan and thus 
eligible for FFP only if the broker and its subcontractors meet the 
following conditions:
    (1) Independence. The broker and its subcontractors are independent 
of any MCO, PIHP, PAHP, PCCM, PCCM entity or other health care provider 
in the State in which they provide enrollment services. A broker or 
subcontractor is not considered ``independent'' if it--
    (i) Is an MCO, PIHP, PAHP, PCCM, PCCM entity or other health care 
provider in the State;
    (ii) Is owned or controlled by an MCO, PIHP, PAHP, PCCM, PCCM 
entity or other health care provider in the State; or
    (iii) Owns or controls an MCO, PIHP, PAHP, PCCM, PCCM entity, or 
other health care provider in the State.
    (2) Freedom from conflict of interest. The broker and its 
subcontractor are free from conflict of interest. A broker or 
subcontractor is not considered free from conflict of interest if any 
person who is the owner, employee, or consultant of the broker or 
subcontractor or has any contract with them--
    (i) Has any direct or indirect financial interest in any entity or 
health care provider that furnishes services in the State in which the 
broker or subcontractor provides enrollment services;
    (ii) Has been excluded from participation under Title XVIII or XIX 
of the Act;
    (iii) Has been debarred by any Federal agency; or
    (iv) Has been, or is now, subject to civil money penalties under 
the Act.
    (3) Approval. The initial contract or memorandum of agreement (MOA) 
for services performed by the broker has been reviewed and approved by 
CMS.


Sec.  438.812  Costs under risk and nonrisk contracts.

    (a) Under a risk contract, the total amount the State agency pays 
for carrying out the contract provisions is a medical assistance cost.
    (b) Under a nonrisk contract--
    (1) The amount the State agency pays for the furnishing of medical 
services to eligible beneficiaries is a medical assistance cost; and
    (2) The amount the State agency pays for the contractor's 
performance of other functions is an administrative cost.


Sec.  438.816  Expenditures for the beneficiary support system for 
enrollees using LTSS.

    State expenditures for the person or entity providing the services 
outlined in Sec.  438.71(d) are considered necessary for the proper and 
efficient operation of the State plan and thus eligible for FFP only if 
all of the following conditions are met:
    (a) Costs must be supported by an allocation methodology that 
appears in the State's approved Public Assistance Cost Allocation Plan 
in Sec.  433.34 of this chapter.
    (b) The costs do not duplicate payment for activities that are 
already being offered or should be provided by other entities or paid 
by other programs.
    (c) The person or entity providing the services must meet the 
requirements in Sec.  438.810(b)(1) and (2).
    (d) The initial contract or MOA for services performed has been 
reviewed and approved by CMS.


Sec.  438.818  Enrollee encounter data.

    (a) FFP is available for expenditures under an MCO, PIHP, or PAHP 
contract only if the State meets the following conditions for providing 
enrollee encounter data to CMS:
    (1) Enrollee encounter data reports must comply with the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) security 
and privacy standards and be submitted in the format required by the 
Medicaid Statistical Information System or format required by any 
successor system to the Medicaid Statistical Information System.
    (2) States must ensure that enrollee encounter data is validated 
for accuracy and completeness as required under Sec.  438.242 before 
submitting data to CMS. States must also validate that the data 
submitted to CMS is a complete and accurate representation of the 
information submitted to the State by the MCOs, PIHPs, and PAHPs.
    (3) States must cooperate with CMS to fully comply with all 
encounter data reporting requirements of the Medicaid Statistical 
Information System or any successor system.
    (b) CMS will assess a State's submission to determine if it 
complies with current criteria for accuracy and completeness.
    (c) If, after being notified of compliance issues under paragraph 
(b) of this section the State is unable to make a data submission 
compliant, CMS will take appropriate steps to defer and/or disallow FFP 
on all or part of an MCO, PIHP, or PAHP contract in a manner based on 
the enrollee and specific service type of the noncompliant data. Any 
deferral and/or disallowance of FFP will be effectuated utilizing the 
processes specified in Sec. Sec.  430.40 and 430.42 of this chapter.

PART 440--SERVICES: GENERAL PROVISIONS

0
11. The authority citation for part 440 continues to read as follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).


0
12. Section 440.262 is added to read as follows:


Sec.  440.262  Access and cultural considerations.

    The State must have methods to promote access and delivery of 
services in a culturally competent manner to all beneficiaries, 
including those with limited English proficiency, diverse

[[Page 27896]]

cultural and ethnic backgrounds, disabilities, and regardless of 
gender, sexual orientation or gender identity. These methods must 
ensure that beneficiaries have access to covered services that are 
delivered in a manner that meet their unique needs.

PART 457--ALLOTMENTS AND GRANTS TO STATES

0
13. The authority citation for part 457 continues to read as follows:

    Authority:  Section 1102 of the Social Security Act (42 U.S.C. 
1302).


0
14. Section 457.10 is amended by:
0
a. Adding the definitions of ``actuarially sound principles'', 
``comprehensive risk contract'', ``external quality review'', and 
``external quality review organization'' in alphabetical order.
0
b. Revising the definition of ``fee-for-service entity''.
0
c. Adding the definitions of ``managed care organization'', ``prepaid 
ambulatory health plan'', ``prepaid inpatient health plan'', ``primary 
care case management'', ``primary care case management entity'', 
``primary care case manager'', ``provider'', and ``risk contract'' in 
alphabetical order.
    The additions and revision read as follows:


Sec.  457.10  Definitions and use of terms.

* * * * *
    Actuarially sound principles means generally accepted actuarial 
principles and practices that are applied to determine aggregate 
utilization patterns, are appropriate for the population and services 
to be covered, and have been certified by actuaries who meet the 
qualification standards established by the Actuarial Standards Board.
* * * * *
    Comprehensive risk contract means a risk contract between the State 
and an MCO that covers comprehensive services, that is, inpatient 
hospital services and any of the following services, or any three or 
more of the following services:
    (1) Outpatient hospital services.
    (2) Rural health clinic services.
    (3) Federally Qualified Health Center (FQHC) services.
    (4) Other laboratory and X-ray services.
    (5) Nursing facility (NF) services.
    (6) Early and periodic screening, diagnostic, and treatment (EPSDT) 
services.
    (7) Family planning services.
    (8) Physician services.
    (9) Home health services.
* * * * *
    External quality review (EQR) means the analysis and evaluation by 
an EQRO, of aggregated information on quality, timeliness, and access 
to the health care services that an MCO, PIHP, or PAHP, or their 
contractors furnish to CHIP beneficiaries.
    External quality review organization (EQRO) means an organization 
that meets the competence and independence requirements set forth in 
Sec.  438.354 of this chapter, and holds a contract with a State to 
perform external quality review, other EQR-related activities as set 
forth in Sec.  438.358 of this chapter, or both.
* * * * *
    Fee-for-service entity means any individual or entity that 
furnishes services under the program on a fee-for-service basis, 
including health insurance services.
* * * * *
    Federally qualified HMO means an HMO that CMS has determined is a 
qualified HMO under section 2791(b)(3) of the Public Health Service 
Act.
    Managed care organization (MCO) means an entity that has, or is 
seeking to qualify for, a comprehensive risk contract under this part, 
and that is--
    (1) A Federally qualified HMO that meets the requirements of 
subpart I of part 489 of this chapter; or
    (2) Makes the services it provides to its CHIP enrollees as 
accessible (in terms of timeliness, amount, duration, and scope) as 
those services are to other CHIP beneficiaries within the area served 
by the entity and
    (3) Meets the solvency standards of Sec.  438.116 of this chapter.
* * * * *
    Prepaid ambulatory health plan (PAHP) means an entity that--
    (1) Provides services to enrollees under contract with the State, 
and on the basis of prepaid capitation payments, or other payment 
arrangements that do not use State plan payment rates.
    (2) Does not provide or arrange for, and is not otherwise 
responsible for the provision of any inpatient hospital or 
institutional services for its enrollees.
    (3) Does not have a comprehensive risk contract.
    Prepaid inpatient health plan (PIHP) means an entity that--
    (1) Provides services to enrollees under contract with the State, 
and on the basis of prepaid capitation payments, or other payment 
arrangements that do not use State plan payment rates.
    (2) Provides, arranges for, or otherwise has responsibility for the 
provision of any inpatient hospital or institutional services for its 
enrollees.
    (3) Does not have a comprehensive risk contract.
* * * * *
    Primary care case management means a system under which:
    (1) A PCCM contracts with the State to furnish case management 
services (which include the location, coordination and monitoring of 
primary health care services) to CHIP beneficiaries; or
    (2) A PCCM entity contracts with the State to provide a defined set 
of functions to CHIP beneficiaries.
    Primary care case management entity (PCCM entity) means an 
organization that provides any of the following functions, in addition 
to primary care case management services, for the State:
    (1) Provision of intensive telephonic or face-to-face case 
management, including operation of a nurse triage advice line.
    (2) Development of enrollee care plans.
    (3) Execution of contracts with and/or oversight responsibilities 
for the activities of fee-for-service providers in the fee-for-service 
program.
    (4) Provision of payments to fee-for-service providers on behalf of 
the State.
    (5) Provision of enrollee outreach and education activities.
    (6) Operation of a customer service call center.
    (7) Review of provider claims, utilization and practice patterns to 
conduct provider profiling and/or practice improvement.
    (8) Implementation of quality improvement activities including 
administering enrollee satisfaction surveys or collecting data 
necessary for performance measurement of providers.
    (9) Coordination with behavioral health systems/providers.
    (10) Coordination with long-term services and supports systems/
providers.
    Primary care case manager (PCCM) means a physician, a physician 
group practice or, at State option, any of the following in addition to 
primary care case management services:
    (1) A physician assistant.
    (2) A nurse practitioner.
    (3) A certified nurse-midwife.
* * * * *
    Provider means any individual or entity that is engaged in the 
delivery of services, or ordering or referring for those services, and 
is legally authorized to do so by the State in which it delivers the 
services.
* * * * *
    Risk contract means a contract under which the contractor--
    (1) Assumes risk for the cost of the services covered under the 
contract.

[[Page 27897]]

    (2) Incurs loss if the cost of furnishing the services exceeds the 
payments under the contract.
* * * * *

0
15. Section 457.204 is amended by revising paragraph (a) to read as 
follows:


Sec.  457.204  Withholding of payment for failure to comply with 
Federal requirements.

    (a) Basis for withholding. CMS withholds payments to the State, in 
whole or in part, only if, after giving the State notice, a reasonable 
opportunity for correction, and an opportunity for a hearing, the 
Administrator finds--
    (1) That the State plan is in substantial noncompliance with the 
requirements of Title XXI of the Act or the regulations in this part; 
or
    (2) That the State is conducting its program in substantial 
noncompliance with either the State plan or the requirements of Title 
XXI of the Act or the regulations in this part. (Hearings are generally 
not called until a reasonable effort has been made to resolve the 
issues through conferences and discussions. These efforts may be 
continued even if a date and place have been set for the hearing.)
    (3) For purposes of this paragraph (a), substantial non-compliance 
includes, but is not limited to, failure to comply with requirements 
that significantly affect federal or state oversight or state 
reporting.
* * * * *


Sec.  457.902  [Removed]

0
16. Section 457.902 is removed.
0
17. Section 457.940 is revised to read as follows:


Sec.  457.940  Procurement standards.

    (a) A State must submit to CMS a written assurance that Title XXI 
services will be provided in an effective and efficient manner. The 
State must submit the assurance--
    (1) With the initial State plan; or
    (2) For States with approved plans, with the first request to amend 
the approved plan.
    (b) A State must provide for free and open competition, to the 
maximum extent practical, in the bidding of all procurement contracts 
for coverage or other services in accordance with the procurement 
requirements of 45 CFR part 75, as applicable.
    (c) All contracts under this part must include provisions that 
define a sound and complete procurement contract, as required by 45 CFR 
part 75, as applicable.

0
18. Section 457.950 is amended by revising paragraph (a) to read as 
follows:


Sec.  457.950  Contract and payment requirements including 
certification of payment-related information.

    (a) MCOs, PAHPs, PIHPs, PCCMs, and PCCM entities. The contract 
requirements for MCOs, PAHPs, PIHPs, PCCMs, and PCCM entities are 
provided in Sec.  457.1201.
* * * * *

0
19. Subpart L is added to part 457 to read as follows:

Subpart L--Managed Care

General Provisions

Sec.
457.1200 Basis, scope, and applicability.
457.1201 Standard contract requirements.
457.1203 Rate development standards and medical loss ratio.
457.1206 Non-emergency medical transportation PAHPs.
457.1207 Information requirements.
457.1208 Provider discrimination prohibited.
457.1209 Requirements that apply to MCO, PIHP, PAHP, PCCM, and PCCM 
entity contracts involving Indians, Indian health care provider 
(IHCP), and Indian managed care entities (IMCE).

State Responsibilities

457.1210 Enrollment process.
457.1212 Disenrollment.
457.1214 Conflict of interest safeguards.
457.1216 Continued services to enrollees.
457.1218 Network adequacy standards.

Enrollee Rights and Protections

457.1220 Enrollee rights.
457.1222 Provider-enrollee communication.
457.1224 Marketing activities.
457.1226 Liability for payment.
457.1228 Emergency and poststabilization services.

MCO, PIHP, and PAHP Standards

457.1230 Access standards.
457.1233 Structure and operation standards.

Quality Measurement and Improvement; External Quality Review

457.1240 Quality measurement and improvement.
457.1250 External quality review.

Grievance System

457.1260 Grievance system.

Sanctions

457.1270 Sanctions.

Subpart L--Managed Care

General Provisions


Sec.  457.1200  Basis, scope, and applicability.

    (a) Statutory basis. This subpart implements the following sections 
of the Act:
    (1) Section 2101(a) of the Act, which provides that the purpose of 
Title XXI is to provide funds to States to enable them to initiate and 
expand the provision of child health assistance to uninsured, low-
income children in an effective and efficient manner.
    (2) Section 2103(f)(3) and 2107(e)(1)(M) of the Act, which apply 
certain provisions of Title XIX related to Medicaid managed care to 
CHIP.
    (3) Sections 2107(b) and 2107(e)(2) of the Act, which relate to 
program integrity.
    (b) Scope. This subpart sets forth requirements for the provision 
of services through MCOs, PIHPs, PAHPs, and PCCM entities, as defined 
in Sec.  457.10.
    (c) Applicability. The requirements of this subpart apply to child 
health assistance provided under a separate child health program 
operating a managed care delivery system. Regulations relating to 
managed care that are applicable to a Medicaid expansion program are 
found at part 438 of this chapter.


Sec.  457.1201  Standard contract requirements.

    (a) CMS review. The State must submit all MCO, PAHP, PIHP, PCCM, 
and PCCM entity contracts for review in the form and manner established 
by CMS.
    (b) Entities eligible for comprehensive risk contracts. The State 
may enter into a comprehensive risk contract only with the entities 
specified in Sec.  438.3(b)(1) through (3) of this chapter.
    (c) Payment. The final capitation rates for all MCO, PIHP or PAHP 
contracts must be identified and developed, and payment must be made in 
accordance with Sec.  438.3(c) of this chapter, except that the 
requirement for preapproval of contracts does not apply, and contract 
rates must be submitted to CMS upon request of the Secretary.
    (d) Enrollment discrimination prohibited. Contracts with MCOs, 
PAHPs, PIHPs, PCCMs and PCCM entities must comply with prohibitions on 
enrollment discrimination in accordance with Sec.  438.3(d) of this 
chapter, except that Sec.  438.3(d)(2) of this chapter (related to 
voluntary enrollment) does not apply.
    (e) Services that may be covered by an MCO, PIHP, or PAHP. An MCO, 
PIHP, or PAHP may cover, for enrollees, services that are not covered 
under the State plan in accordance with Sec.  438.3(e) of this chapter.
    (f) Compliance with applicable laws and conflict of interest 
safeguards. Contracts with MCOs, PAHPs, PIHPs, PCCMs or PCCM entities 
must comply with Federal laws and regulations in accordance with Sec.  
438.3(f) of this chapter.

[[Page 27898]]

    (g) Inspection and audit of records and access to facilities. 
Contracts with MCOs, PIHPs, PAHPs, PCCMs or PCCM entities must allow 
for the inspection and audit of records and access to facilities in 
accordance with Sec.  438.3(h) of this chapter.
    (h) Physician incentive plans. If a contract with an MCO, PAHP, or 
PIHP provides for a physician incentive plan, it must comply with Sec.  
438.3(i) of this chapter (which cross references Sec. Sec.  422.208 and 
422.210 of this chapter).
    (i) Subcontractual relationships and delegations. The state must 
ensure, through its contracts with MCOs, PIHPs, and PAHPs, that any 
contract or written agreement that the MCO, PIHP, or PAHP has with any 
individual or entity that relates directly or indirectly to the 
performance of the MCOs, PIHPs, or PAHPs obligations under its contract 
comply with Sec.  457.1233(b) (which cross references Sec.  438.230 of 
this chapter).
    (j) Choice of network provider. The contract must allow each 
enrollee to choose his or her network provider in accordance with Sec.  
438.3(l) of this chapter.
    (k) Audited financial reports. Contracts with MCOs, PAHPs, and 
PIHPs must comply with the requirements for submission of audited 
financial reports in Sec.  438.3(m) of this chapter.
    (l) Parity in mental health and substance use disorder benefits. 
Contracts with MCOs, PAHPs, and PIHPs must comply with the requirements 
of Sec.  438.3(n).
    (m) Additional rules for contracts with PCCMs. Contracts with PCCMs 
must comply with the requirements of Sec.  438.3(q) of this chapter, 
except that the right to disenroll is in accordance with Sec.  
457.1212.
    (n) Additional rules for contracts with PCCM entities. (1) States 
must submit PCCM entity contracts to CMS for review.
    (2) Contracts with PCCMs must comply with the requirements of 
paragraph (o) of this section; Sec.  457.1207; Sec.  457.1240(b) 
(cross-referencing Sec.  438.330(b)(3), (c), and (e) of this chapter); 
Sec.  457.1240(e) (cross-referencing Sec.  438.340 of this chapter); 
and Sec.  457.1250(a) (cross-referencing Sec.  438.350 of this 
chapter).
    (o) Attestations. Contracts with MCO, PAHP, PIHP, PCCM or PCCM 
entities must include an attestation to the accuracy, completeness, and 
truthfulness of claims and payment data, under penalty of perjury.
    (p) Guarantee not to avoid costs. Contracts with an MCO, PAHP, 
PIHP, PCCM or PCCM entities must include a guarantee that the MCO, 
PAHP, PIHP, PCCM or PCCM entity will not avoid costs for services 
covered in its contract by referring enrollees to publicly supported 
health care resources.
    (q) Recordkeeping requirements. Contracts with MCOs, PIHPs, and 
PAHPs, must comply with the recordkeeping requirements of Sec.  
438.3(u) of this chapter.


Sec.  457.1203  Rate development standards and medical loss ratio.

    (a) A state must use payment rates based on public or private 
payment rates for comparable services for comparable populations, 
consistent with actuarially sound principles as defined at Sec.  
457.10. This requirement for using actuarially sound principles to 
develop payment rates does not prohibit a state from (implementing 
value-based purchasing models for provider reimbursement, such as pay 
for performance arrangements, bundled payments, or other service 
payment models intended to recognize value or outcomes over volume of 
services; such alternate payment models should be developed using 
actuarially sound principles to the extent applicable.
    (b) A State may establish higher rates than permitted under 
paragraph (a) of this section if such rates are necessary to ensure 
sufficient provider participation or provider access or to enroll 
providers who demonstrate exceptional efficiency or quality in the 
provision of services.
    (c) The rates must be designed to reasonably achieve a medical loss 
ratio standard, calculated in accordance with the provisions of Sec.  
438.8 of this chapter, that--
    (1) Is equal to at least 85 percent for the rate year; and
    (2) Provides for reasonable administrative costs.
    (d) The State must provide to CMS, if requested, a description of 
the manner in which rates were developed in accordance with the 
requirements of paragraphs (a), (b), or (c) of this section.
    (e) The state must comply with the requirements related to medical 
loss ratios in accordance with the terms of Sec.  438.74 of this 
chapter, except that the description of the reports received from the 
MCOs PIHPs and PAHPs under to Sec.  438.8(k) of this chapter will be 
submitted independently, and not with the actuarial certification 
described in Sec.  438.7 of this chapter.
    (f) The state must ensure, through its contracts, that each MCO, 
PIHP, and PAHP complies with the requirements Sec.  438.8 of this 
chapter.


Sec.  457.1206  Non-emergency medical transportation PAHPs.

    (a) For purposes of this section Non-Emergency Medical 
Transportation (NEMT) Prepaid Ambulatory Health Plan (PAHP) means an 
entity that provides only NEMT services to enrollees under contract 
with the State, and on the basis of prepaid capitation payments, or 
other payment arrangements that do not use State plan payment rates.
    (b) The following requirements and options apply to NEMT PAHPs, 
NEMT PAHP contracts, and States in connection with NEMT PAHPs, to the 
same extent that they apply to PAHPs, PAHP contracts, and States in 
connection with PAHPs.
    (1) All contract provisions in Sec.  457.1201 except those set 
forth in Sec.  457.1201(h) (related to physician incentive plans) Sec.  
457.1201(l) (related to mental health parity).
    (2) The information requirements in Sec.  457.1207.
    (3) The provision against provider discrimination in Sec.  
457.1208.
    (4) The State responsibility provisions in Sec. Sec.  457.1212 and 
457.1214, and Sec.  438.62(a) of this chapter, as cross-referenced in 
Sec.  457.1216.
    (5) The provisions on enrollee rights and protections in Sec. Sec.  
457.1220, 457.1222, 457.1224, and 457.1226.
    (6) The PAHP standards in Sec.  438.206(b)(1) of this chapter, as 
cross-referenced by Sec. Sec.  457.1230(a), 457.1230(d), and 
457.1233(a), (b) and (d).
    (7) An enrollee's right to a State review under subpart K of this 
part.
    (8) Prohibitions against affiliations with individuals debarred or 
excluded by Federal agencies in Sec.  438.610 of this chapter, as cross 
referenced by Sec.  457.1285.
    (9) Requirements relating to contracts involving Indians, Indian 
Health Care Providers, and Indian managed care entities in Sec.  
457.1209.


Sec.  457.1207  Information requirements.

    The State must provide, or ensure its contracted MCO, PAHP, PIHP, 
PCCM and PCCM entities provide, all enrollment notices, informational 
materials, and instructional materials related to enrollees and 
potential enrollees in accordance with the terms of Sec.  438.10 of 
this chapter.


Sec.  457.1208  Provider discrimination prohibited.

    The state must ensure through its contracts that each MCO, PIHP, 
and PAHP follow the requirements related to the prohibition on provider 
discrimination in Sec.  438.12 of this chapter.

[[Page 27899]]

Sec.  457.1209  Requirements that apply to MCO, PIHP, PAHP, PCCM, and 
PCCM entity contracts involving Indians, Indian health care provider 
(IHCP), and Indian managed care entities (IMCE).

    The State must follow, and ensure through its contracts, that each 
MCO, PIHP, PAHP, PCCM, and PCCM entity follows, the requirements 
related to Indians, IHCPs, and IMCEs in accordance with the terms of 
Sec.  438.14 of this chapter.

State Responsibilities


Sec.  457.1210  Enrollment process.

    (a) Default enrollment process. (1) If a state uses a default 
enrollment process to assign beneficiaries to a MCO, PIHP, PAHP, PCCM, 
or PCCM entity, the process must:
    (i) Assign beneficiaries to a qualified MCO, PIHP, PAHP, PCCM or 
PCCM entity. To be qualified, the MCO, PIHP, PAHP, PCCM or PCCM entity 
must:
    (A) Not be subject to the intermediate sanction described in Sec.  
438.702(a)(4) of this chapter.
    (B) Have capacity to enroll beneficiaries.
    (ii) Maximize continuation of existing provider-beneficiary 
relationships. An ``existing provider-beneficiary relationship'' is one 
in which the provider was the main source of CHIP services for the 
beneficiary during the previous year. This may be established through 
State records of previous managed care enrollment or fee-for-service 
experience, encounter data, or through contact with the beneficiary.
    (iii) If the approach in paragraph (a)(1)(ii) of this section is 
not possible, the State must distribute the beneficiaries equitably 
among the MCOs, PIHPs, PAHPs, PCCMs and PCCM entities. The State may 
not arbitrarily exclude any MCO, PIHP, PAHP, PCCM or PCCM entity from 
being considered.
    (2) The State may consider additional reasonable criteria to 
conduct the default enrollment process, including the previous plan 
assignment of the beneficiary, quality assurance and improvement 
performance, procurement evaluation elements, accessibility of provider 
offices for people with disabilities (when appropriate), and other 
reasonable criteria that support the objectives of the managed care 
program.
    (3) The State must send a confirmation of the enrollee's managed 
care enrollment to the enrollee within 5 calendar days of the date such 
enrollment is processed by the State. The confirmation must clearly 
explain the enrollee's right to disenroll within 90 days from the 
effective date of the enrollment.
    (b) Priority for enrollment. The state must have an enrollment 
system under which beneficiaries already enrolled in an MCO, PIHP, 
PAHP, PCCM, or PCCM entity are given priority to continue that 
enrollment if the MCO, PIHP, PAHP, PCCM, or PCCM entity does not have 
the capacity to accept all those seeking enrollment under the program.
    (c) Informational notices. A State must provide an informational 
notice to each potential enrollee who may enroll in an MCO, PIHP, PAHP, 
PCCM, or PCCM entity. Such notice must:
    (1) Include the MCOs, PIHPs, PAHPs, PCCMs, or PCCM entities 
available to the potential enrollee;
    (2) Explains how to select an MCO, PIHP, PAHP, PCCM, or PCCM 
entity;
    (3) Explain the implications of making or not making an active 
choice of an MCO, PIHP, PAHP, PCCM or PCCM entity;
    (4) Explains the length of the enrollment period as well as the 
disenrollment policies in Sec.  457.1212; and
    (5) Comply with the information requirements in Sec.  457.1207 and 
accessibility standards established under Sec.  457.340.


Sec.  457.1212  Disenrollment.

    The State must comply with and ensure, through its contracts, that 
each MCO, PAHP, PIHP, PCCM and PCCM entity complies with the 
disenrollment requirements in accordance with the terms of Sec.  438.56 
of this chapter, except that references to fair hearings should be read 
to refer to reviews as described in subpart K of this part.


Sec.  457.1214  Conflict of interest safeguards.

    The State must have in effect safeguards against conflict of 
interest in accordance with the terms of Sec.  438.58 of this chapter.


Sec.  457.1216  Continued services to enrollees.

    The State must follow the requirements related to continued 
services to enrollees in accordance with the terms of Sec.  438.62 of 
this chapter.


Sec.  457.1218  Network adequacy standards.

    The State must develop network adequacy standards in accordance 
with the terms of Sec.  438.68 of this chapter, and, ensure through its 
contracts, that each MCO, PAHP, and PIHP meets such standards.

Enrollee Rights and Protections


Sec.  457.1220  Enrollee rights.

    The State must ensure, through its contracts, that each MCO, PIHP, 
PAHP, PCCM, and PCCM entity follow the enrollee rights requirements in 
accordance with the terms of Sec.  438.100 of this chapter.


Sec.  457.1222  Provider-enrollee communication.

    The State must ensure, through its contracts, that each MCO, PIHP, 
and PAHP protects communications between providers and enrollees in 
accordance with the terms of Sec.  438.102 of this chapter.


Sec.  457.1224  Marketing activities.

    The State must ensure, through its contracts, that each MCO, PIHP, 
PAHP, PCCM, and PCCM entity follows the requirements related to 
marketing activities in accordance with the terms of Sec.  438.104 of 
this chapter, except Sec.  438.104(c) of this chapter related to state 
agency review does not apply.


Sec.  457.1226  Liability for payment.

    The State must ensure, through its contracts, that enrollees of 
MCOs, PIHPs, and PAHPs are not held liable for services or debts of the 
MCO, PIHP, or PAHPs in accordance with the terms of Sec.  438.106 of 
this chapter.


Sec.  457.1228  Emergency and poststabilization services.

    The State must ensure that emergency services, as defined in Sec.  
457.10 of this chapter, are available and accessible to enrollees in 
accordance with the terms of Sec.  438.114 of this chapter.

MCO, PIHP, and PAHP Standards


Sec.  457.1230  Access standards.

    (a) Availability of services. The State must ensure that the 
services are available and accessible to enrollees in accordance with 
the terms of Sec.  438.206 of this chapter.
    (b) Assurances of adequate capacity and services. The State must 
ensure, through its contracts, that each MCO, PIHP and PAHP has 
adequate capacity to serve the expected enrollment in accordance with 
the terms of Sec.  438.207 of this chapter.
    (c) Coordination and continuity of care. The State must ensure, 
through its contracts, that each MCO, PIHP and PAHP complies with the 
coordination and continuity of care requirements in accordance with the 
terms of Sec.  438.208 of this chapter.
    (d) Coverage and authorization of services. The State must ensure, 
through its contracts, that each MCO, PIHP or PAHP complies with the 
coverage and authorization of services requirements in accordance with 
the terms of Sec.  438.210 of this chapter, except that the following 
do not apply: Sec.  438.210(a)(5)

[[Page 27900]]

of this chapter (related to medical necessity standard); and Sec.  
438.210(b)(2)(iii) of this chapter (related to authorizing LTSS).


Sec.  457.1233  Structure and operation standards.

    (a) Provider selection. The State must ensure, through its 
contracts, that each MCO, PIHP or PAHP complies with the provider 
selection requirements as provided in Sec.  438.214 of this chapter.
    (b) Subcontractual relationships and delegation. The State must 
ensure, through its contracts, that each MCO, PIHP and PAHP complies 
with the subcontractual relationships and delegation requirements as 
provided in Sec.  438.230 of this chapter.
    (c) Practice guidelines. The state must ensure, through its 
contracts, that each MCO and, when applicable, each PIHP and PAHP, 
complies with the practice guidelines requirements as provided in Sec.  
438.236 of this chapter.
    (d) Health information systems. The State must ensure, through its 
contracts, that each MCO, PIHP, and PAHP complies with the health 
information systems requirements as provided in Sec.  438.242 of this 
chapter.
    (e) Privacy protections. The state must ensure, through its 
contracts, that each MCO, PIHP, and PAHP complies with the privacy 
protections as provided in Sec.  457.1110.

Quality Measurement and Improvement; External Quality Review


Sec.  457.1240  Quality measurement and improvement.

    (a) Scope. This section sets forth requirements related to quality 
assessment and performance improvement that the State must meet in 
contracting with an MCO, PIHP, PAHP, or certain PCCM entities.
    (b) Quality assessment and performance improvement program. The 
State must require, through its contracts, that each MCO, PIHP, and 
PAHP must establish and implement an ongoing comprehensive quality 
assessment and performance improvement program for the services it 
furnishes to its enrollees as provided in Sec.  438.330 of this 
chapter, except that the terms of Sec.  438.330(d)(4) of this chapter 
(related to dual eligibles) do not apply. In the case of a contract 
with a PCCM entity described in paragraph (f) of this section, Sec.  
438.330(b)(3), (c), and (e) of this chapter apply.
    (c) State review of the accreditation status of MCOs, PIHPs, and 
PAHPs. The State must review the accreditation status of each MCO, 
PIHP, and PAHP in accordance with the requirements as set forth in 
Sec.  438.332 of this chapter.
    (d) Managed care quality rating system. The State must determine a 
quality rating or ratings for each MCO, PIHP, and PAHP in accordance 
with the requirements set forth in Sec.  438.334 of this chapter.
    (e) Managed care quality strategy. The State must draft and 
implement a written quality strategy for assessing and improving the 
quality of health care and services furnished CHIP enrollees as 
described in Sec.  438.340 of this chapter. In the case of a contract 
with a PCCM entity described in paragraph (f) of this section, Sec.  
438.340 (e) of this chapter apply.
    (f) Applicability to PPCM entities. For purposes of paragraphs (b) 
and (e) of this section and Sec.  457.1250(a), a PCCM entity described 
in this paragraph is a PCCM entity whose contract with the State 
provides for shared savings, incentive payments or other financial 
reward for improved quality outcomes.


Sec.  457.1250  External quality review.

    (a) Each State that contracts with MCOs, PIHPs, or PAHPs must 
follow all applicable external quality review requirements as set forth 
in Sec. Sec.  438.350, 438.352, 438.354, 438.356, 438.358, 438.360 
(only with respect to nonduplication of EQR activities with private 
accreditation) and 438.364 of this chapter. In the case of a contract 
with a PCCM entity described in Sec.  457.1240(f), Sec.  438.350 of 
this chapter applies.
    (b) A State may amend an existing EQRO contract to include the 
performance of EQR-related activities and/or EQR in accordance with 
paragraph (a) of this section.

Grievance System


Sec.  457.1260  Grievance system.

    The State must ensure that its contracted MCOs, PIHPs, and PAHPs 
comply with the grievance and appeals requirements and procedures in 
accordance with the terms of subpart F of part 438 of this chapter, 
except that the terms of Sec.  438.420 of this chapter do not apply and 
that references to fair hearings should be read to refer to reviews as 
described in subpart K of this part.

Sanctions


Sec.  457.1270  Sanctions.

    The State must comply, and ensure that its contracted MCOs comply, 
with the sanctions requirements in accordance with the terms of subpart 
I of part 438 of this chapter.


Sec.  457.955  [Redesignated as Sec.  457.1280]

0
20. Section 457.955 is redesignated as Sec.  457.1280 and transferred 
from subpart I to subpart L.
0
21. Newly redesignated Sec.  457.1280 is amended by revising the 
section heading and paragraphs (a), (b)(1), (b)(2), (b)(3), and (d) to 
read as follows:


Sec.  457.1280  Conditions necessary to contract as an MCO, PAHP, or 
PIHP.

    (a) The State must assure that any entity seeking to contract as an 
MCO, PAHP, or PIHP under a separate child health program has 
administrative and management arrangements or procedures designed to 
safeguard against fraud and abuse.
    (b) * * *
    (1) Enforce MCO, PAHP, and PIHP compliance with all applicable 
Federal and State statutes, regulations, and standards.
    (2) Prohibit MCOs, PAHPs, and PIHPs from conducting any unsolicited 
personal contact with a potential enrollee by an employee or agent of 
the MCO, PAHP, or PIHP for the purpose of influencing the individual to 
enroll with the entity.
    (3) Include a mechanism for MCOs, PAHPs, and PIHPs to report to the 
State, to CMS, or to the Office of Inspector General (OIG) as 
appropriate, information on violations of law by subcontractors, 
providers, or enrollees of an MCO, PAHP, or PIHP and other individuals.
* * * * *
    (d) The State may inspect, evaluate, and audit MCOs, PIHPs, and 
PAHPs at any time, as necessary, in instances where the State 
determines that there is a reasonable possibility of fraudulent or 
abusive activity.

0
22. Section 457.1285 is added to subpart L to read as follows:


Sec.  457.1285  Program integrity safeguards.

    The state must comply with the program integrity safeguards in 
accordance with the terms of subpart H of part 438, except that the 
terms of Sec.  438.604(a)(2) of this chapter do not apply.

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
23. The authority citation for part 495 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

[[Page 27901]]

Sec.  495.332  [Amended]

0
24. In Sec.  495.332, amend paragraph (d)(2) by removing the reference 
``Sec.  438.6(v)(5)(iii)'' and adding in its place the reference 
``Sec.  438.6(b)(2)''.


Sec.  495.366  [Amended]

0
25. In Sec.  495.366, amend paragraph (e)(7) by removing the reference 
``Sec.  438.6(c)(5)(iii)'' and adding in its place the reference 
``Sec.  438.6(b)(2)''.

    Dated: March 9, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 19, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-09581 Filed 4-25-16; 4:15 pm]
 BILLING CODE 4120-01-P