[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Proposed Rules]
[Pages 54982-55088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23599]
[[Page 54981]]
Vol. 83
Thursday,
No. 212
November 1, 2018
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 422, 423, 438, et al.
Medicare and Medicaid Programs; Policy and Technical Changes to the
Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-
Inclusive Care for the Elderly, Medicaid Fee-for-Service, and Medicaid
Managed Care Programs for Years 2020 and 2021; Proposed Rule
Federal Register / Vol. 83 , No. 212 / Thursday, November 1, 2018 /
Proposed Rules
[[Page 54982]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 422, 423, 438, and 498
[CMS-4185-P]
RIN 0938-AT59
Medicare and Medicaid Programs; Policy and Technical Changes to
the Medicare Advantage, Medicare Prescription Drug Benefit, Program of
All-Inclusive Care for the Elderly (PACE), Medicaid Fee-for-Service,
and Medicaid Managed Care Programs for Years 2020 and 2021
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would revise the Medicare Advantage (MA)
program (Part C) regulations and Prescription Drug Benefit program
(Part D) regulations to implement certain provisions of the Bipartisan
Budget Act of 2018; improve quality and accessibility; clarify certain
program integrity policies; reduce burden on providers, MA plans, and
Part D sponsors through providing additional policy clarification; and
implement other technical changes regarding quality improvement. This
proposed rule would also revise the appeals and grievances requirements
for Medicaid managed care and MA special needs plans for dually
eligible individuals to implement certain provisions of the Bipartisan
Budget Act of 2018.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on December 31,
2018.
ADDRESSES: In commenting, please refer to file code CMS-4185-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-4185-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-4185-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Theresa Wachter, (410) 786-1157, or Cali Diehl, (410) 786-4053, MA/Part
C Issues.
Elizabeth Goldstein, (410) 786-6665, Parts C and D Quality Ratings
Issues.
Mark Smith, (410) 786-8015, Prescription Drug Plan Access to Parts A
and B Data Issues.
Vanessa Duran, (410) 786-8697, D-SNP Issues.
Frank Whelan, (410) 786-1302, Preclusion List Issues.
Jonathan Smith (410) 786-4671, or Joanne Davis, (410) 786-5127, MA RADV
Issues.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following website as soon as possible after they have been
received: http://www.regulations.gov. Follow the search instructions on
that website to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Executive Summary
A. Purpose
The primary purposes of this proposed rule are to: make revisions
to the Medicare Advantage (MA) program (Part C) and Prescription Drug
Benefit Program (Part D) regulations based on our continued experience
in the administration of the Part C and Part D programs and to
implement certain provisions of the Bipartisan Budget Act of 2018. The
proposed changes are necessary to--
Implement the Bipartisan Budget Act of 2018 provisions;
Improve program quality and accessibility;
Clarify program integrity policies; and
Implement other changes.
This proposed rule would meet the Administration's priorities to
reduce burden across the Medicare program by reducing unnecessary
regulatory complexity, and improve the regulatory framework to
facilitate development of Part C and Part D products that better meet
the individual beneficiary's healthcare needs. Because the Bipartisan
Budget Act of 2018 requires the Secretary to establish procedures, to
the extent feasible, for integration and unification of the appeals and
grievance processes for dually eligible beneficiaries who are enrolled
in Medicaid and in MA special needs plans for dually eligible
individuals, this proposed rule also includes proposals to revise the
appeals and grievances requirements for Medicaid managed care and MA
special needs plans for dually eligible individuals. We note CMS plans
to release a proposed Medicare rule in the near future to further the
President's agenda of reducing drug costs.
B. Summary of the Major Provisions
1. Requirements for Medicare Advantage Plans Offering Additional
Telehealth Benefits (Sec. Sec. 422.100, 422.135, 422.252, 422.254, and
422.264)
Section 50323 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123) created a new section 1852(m) of the Social Security Act (the
Act), which allows MA plans to provide ``additional telehealth
benefits'' to enrollees starting in plan year 2020 and treat them as
basic benefits for purposes of bid submission and payment by CMS. The
statute limits these authorized additional telehealth benefits to
services for which benefits are available under Medicare Part B, but
that are not payable under section 1834(m) of the Act and have been
identified for the applicable year as clinically appropriate to furnish
through electronic information and telecommunications technology
(section 1852(m)(2)(A)(i) of the Act). Under this proposal, MA plans
would be permitted to offer--as part of the basic benefit package--
additional telehealth benefits beyond what is currently allowable under
the original Medicare telehealth benefit. In addition, we propose to
continue authority for
[[Page 54983]]
MA plans to offer supplemental benefits (that is, benefits not covered
by original Medicare) via remote access technologies and/or
telemonitoring for those services that do not meet the requirements for
additional telehealth benefits.
Section 1852(m)(4) of the Act mandates that enrollee choice is a
priority. If an MA plan covers a Part B service as an additional
telehealth benefit, then the MA plan must also provide access to such
service through an in-person visit and not only as an additional
telehealth benefit. The enrollee must have the option whether to
receive such service through an in-person visit or as an additional
telehealth benefit. In addition, section 1852(m)(2)(A)(ii) of the Act
excludes from additional telehealth benefits any capital and
infrastructure costs and investments relating to such benefits. These
statutory provisions have guided our proposal.
We propose to establish regulatory requirements that would allow MA
plans to cover Part B benefits furnished through electronic exchange as
``additional telehealth benefits''--and as part of the basic benefits
defined in Sec. 422.101--instead of separate supplemental benefits. We
believe additional telehealth benefits would increase access to
patient-centered care by giving enrollees more control to determine
when, where, and how they access benefits. We are soliciting comments
from stakeholders on various aspects of our proposal, which would help
inform CMS's next steps related to implementing the additional
telehealth benefits.
2. Dual Eligible Special Needs Plans Provisions (Sec. Sec. 422.2,
422.60, 422.102, 422.107, 422.111, 422.560 Through 422.562, 422.566,
422.629 Through 422.634, 422.752, 438.210, 438.400, and 438.402)
Section 50311(b) of the Bipartisan Budget Act of 2018 amends
section 1859 of the Act to require integration of the Medicare and
Medicaid benefits provided to enrollees in Dual Eligible Special Needs
Plans (D-SNPs). In particular, the statute requires: (1) Development of
unified grievance and appeals processes for D-SNPs; and (2)
establishment of new standards for integration of Medicare and Medicaid
benefits for D-SNPs.
The statute specifies a number of key elements for unified D-SNP
grievance and appeals processes and grants the Secretary discretion to
determine the extent to which unification of these processes is
feasible. In particular, the unified processes must adopt the
provisions from section 1852(f) and (g) of the Act (MA grievances and
appeals) and sections 1902(a)(3) and (5), and 1932(b)(4) of the Act
(Medicaid grievances and appeals, including managed care) that are most
protective to the enrollee, take into account differences in state
Medicaid plans to the extent necessary, be easily navigable by an
enrollee, include a single written notification of all applicable
grievance and appeal rights, provide a single pathway for resolution of
a grievance or appeal, provide clear notices, employ unified timeframes
for grievances and appeals, establish requirements for how the plan
must process, track, and resolve grievances and appeals, and with
respect to benefits covered under Medicare Parts A and B and Medicaid,
incorporate existing law that provides continuation of benefits pending
appeal for items and services covered under Medicare and Medicaid. The
statute requires the Secretary to establish unified grievance and
appeals procedures by April 1, 2020 and requires D-SNP contracts with
state Medicaid agencies to use the unified procedures for 2021 and
subsequent years.
With respect to the establishment of new standards for integration
of Medicare and Medicaid benefits, the statute requires that all D-SNPs
meet certain new minimum criteria for such integration for 2021 and
subsequent years, either by covering Medicaid benefits through a
capitated payment from a state Medicaid agency or meeting a minimum set
of requirements as determined by the Secretary. The law also stipulates
that for the years 2021 through 2025, if the Secretary determines that
a D-SNP failed to meet one of these integration standards, the
Secretary may impose an enrollment sanction, which would prevent the D-
SNP from enrolling new members. In describing the ``additional minimum
set of requirements'' established by the Secretary, the statute directs
the Federally Coordinated Health Care Office in CMS to base such
standards on ``input from stakeholders.'' We intend to use this
rulemaking to solicit input from stakeholders on the implementation of
these new statutory provisions as well as to clarify definitions and
operating requirements for D-SNPs.
3. Medicare Advantage and Part D Prescription Drug Plan Quality Rating
System (Sec. Sec. 422.162(a) and 423.182(a), Sec. Sec. 422.166(a) and
423.186(a), Sec. Sec. 422.164 and 423.184, and Sec. Sec.
422.166(i)(1) and 423.186(i)(1))
In the Medicare Program; Contract Year 2019 Policy and Technical
Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-
for-Service, the Medicare Prescription Drug Benefit Programs, and the
PACE Program Final Rule (hereafter referred to as the April 2018 final
rule), CMS codified at Sec. Sec. 422.160, 422.162, 422.164, and
422.166 (83 FR 16725 through 16731) and Sec. Sec. 423.180, 423.182,
423.184, and 423.186 (83 FR 16743 through 16749) the methodology for
the Star Ratings system for the MA and Part D programs, respectively.
This was part of the Administration's effort to increase transparency
and advance notice regarding enhancements to the Part C and D Star
Ratings program. That final rule included mechanisms for the removal of
measures for specific reasons (low statistical reliability and when the
clinical guidelines associated with the specifications of measures
change such that the specifications are no longer believed to align
with positive health outcomes) but, generally, removal of a measure for
other reasons would also occur through rulemaking.
At this time, we are proposing enhancements to the cut point
methodology for non-Consumer Assessment of Healthcare Providers and
Systems (CAHPS) measures. We are also proposing substantive updates to
the specifications for a few measures for the 2022 and 2023 Star
Ratings, and rules for calculating Star Ratings in the case of extreme
and uncontrollable circumstances. Unless otherwise stated, data would
be collected and performance measured using these proposed rules and
regulations for the 2020 measurement period and the 2022 Star Ratings.
4. Preclusion List Requirements for Prescribers in Part D and
Individuals and Entities in MA, Cost Plans, and PACE (Sec. Sec.
422.222 and 423.120(c)(6))
In the April 2018 final rule, CMS removed several requirements
pertaining to MA and Part D provider and prescriber enrollment that
were to become effective on January 1, 2019. We stated in that final
rule our belief that the best means of reducing the burden of the MA
and Part D provider and prescriber enrollment requirements without
compromising our payment safeguard objectives would be to focus on
providers and prescribers that pose an elevated risk to Medicare
beneficiaries and the Trust Funds. That is, rather than require the
enrollment of MA providers and Part D prescribers regardless of the
level of risk they might pose, we would prevent payment for MA items or
services and Part D drugs that are, as applicable, furnished or
prescribed by demonstrably problematic
[[Page 54984]]
providers and prescribers. Therefore, we established in the April 2018
final rule a policy under which: (1) Such problematic parties would be
placed on a ``preclusion list''; and (2) payment for MA services and
items and Part D drugs furnished or prescribed by these individuals and
entities would be rejected or denied, as applicable. The MA and Part D
enrollment requirements, in short, were replaced with the payment-
oriented approach of the preclusion list.
This proposed rule would make several revisions and additions to
the preclusion list provisions we finalized in the April 2018 final
rule. We believe these changes would help clarify for stakeholders CMS'
expectations with respect to the preclusion list.
5. Medicare Advantage Risk Adjustment Data Validation (RADV) Provisions
(Sec. Sec. 422.300, 422.310(e), and 422.311(a))
The Medicare Advantage Risk Adjustment Data Validation (RADV)
program was implemented as the primary corrective action to reduce the
Part C improper payment rate in compliance with the Improper Payments
Information Act (IPIA) of 2002, as amended by the Improper Payments
Elimination and Recovery Act (IPERA) of 2010 and updated by the
Improper Payments Elimination and Recovery Improvement Act (IPERIA) of
2012. In this proposed rule, we would, based on longstanding case law
and best practices from HHS and other federal agencies, establish that
extrapolation may be utilized as a valid part of audit authority in
Part C, as it has been historically a normal part of auditing practice
throughout the Medicare program.
Accordingly, we are proposing the following:
To establish that CMS would use extrapolation in RADV
contract-level audits and that the extrapolation authority would apply
to the payment year 2011 contract-level audits and all subsequent
audits.
Not to apply a fee-for-service (FFS) Adjuster to audit
findings.
C. Summary of Costs and Benefits
BILLING CODE 4120-01-P
[[Page 54985]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.000
[[Page 54986]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.001
[[Page 54987]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.002
BILLING CODE 4120-01-C
II. Provisions of the Proposed Regulations
A. Implementing the Bipartisan Budget Act of 2018 Provisions
1. Requirements for Medicare Advantage Plans Offering Additional
Telehealth Benefits (Sec. Sec. 422.100, 422.135, 422.252, 422.254, and
422.264)
Technologies that enable healthcare providers to deliver care to
patients in locations remote from the providers (hereafter referred to
as ``telehealth'') are increasingly being used to complement face-to-
face patient-provider encounters. Telehealth visits among rural
Medicare beneficiaries in particular have increased more than 25
percent a year for the past decade.\1\ In MA, about 81 percent of MA
plans offer supplemental telehealth benefits in the form of remote
access technologies in 2018, an increase from 77 percent in 2017. These
statistics show that the healthcare industry has made significant
advances in technology that enable secure, reliable, real-time,
interactive communication and data transfer that were not possible in
the past. Moreover, the use of telehealth as a care delivery option for
MA enrollees may improve access to and timeliness of needed care,
increase convenience for patients, increase communication between
providers and patients, enhance care coordination, improve quality, and
reduce costs related to in-person care.\2\
---------------------------------------------------------------------------
\1\ Mehrotra, A., Jena, A., Busch, A., Souza, J., Uscher-Pines,
L., Landon, B. (2016). ``Utilization of Telemedicine Among Rural
Medicare Beneficiaries.'' JAMA, 315(18): 2015-2016.
\2\ Medicare Payment Advisory Commission (MedPAC), Report to the
Congress: Medicare Payment Policy, March 2018.
---------------------------------------------------------------------------
MA basic benefits are structured and financed based on what is
covered under Parts A and B (paid through the capitation rate by the
government) with coverage of additional items and services and more
generous cost sharing provisions financed as supplemental benefits
(paid using rebate dollars or supplemental premiums paid by enrollees).
Traditionally, MA plans have been limited in how they may deliver
telehealth services outside of the original Medicare telehealth benefit
under section 1834(m) of the the Act because of this financing
structure; only services covered by original Medicare under Parts A and
B, with actuarially equivalent cost sharing, are in the basic benefit
bid paid by the capitation rate. Section 1834(m) of the Act and Sec.
410.78 generally limit payment for telehealth services in original
Medicare by authorizing payment only for specific services provided
using an interactive audio and video telecommunications system that
permits real-time communication between a Medicare beneficiary and a
physician or certain other practitioner and by specifying
[[Page 54988]]
where the beneficiary may receive care (eligible originating sites).
Originating sites generally are limited by both geography and patient
setting. The statute grants the Secretary the authority to add to the
list of allowable telehealth services based on an established annual
process, but does not generally provide exceptions from the statutory
limitations relating to geography or patient setting. Because sections
1852(a), 1853, and 1854 of the Act limit the basic benefits covered by
the government's capitation payment to only Parts A and B services
covered under original Medicare with actuarially equivalent cost
sharing, telehealth benefits offered by MA plans in addition to those
covered by original Medicare are currently offered as supplemental
benefits and funded through the use of rebate dollars and/or
supplemental premiums paid by enrollees.
On February 9, 2018, President Trump signed the Bipartisan Budget
Act of 2018 (Pub. L. 115-123) into law. Section 50323 of the Bipartisan
Budget Act of 2018 created a new section 1852(m) of the Act, which
allows MA plans to provide ``additional telehealth benefits'' to
enrollees starting in plan year 2020 and treat them as basic benefits
(also known as ``original Medicare benefits'' or ``benefits under the
original Medicare fee-for-service program option'') for purposes of bid
submission and payment by CMS. The statute limits these authorized
``additional telehealth benefits'' to services for which benefits are
available under Medicare Part B but that are not payable under section
1834(m) of the Act and have been identified for the applicable year as
clinically appropriate to furnish through electronic information and
telecommunications technology (hereinafter referred to as ``electronic
exchange''). While MA plans have always been able to offer more
telehealth services than are currently payable under original Medicare
through supplemental benefits, this change in how such additional
telehealth benefits are financed (that is, accounted for in the
capitated payment) makes it more likely that MA plans will offer them
and that more enrollees will use the benefit.
We are proposing to add a new regulation at Sec. 422.135 to
implement the new section 1852(m) of the Act and to amend existing
regulations at Sec. Sec. 422.100, 422.252, 422.254, and 422.264.
Specifically, we propose to add a new regulation, to be codified at
Sec. 422.135, to allow MA plans to offer additional telehealth
benefits, to establish definitions applicable to this new
classification of benefits, and to enact requirements and limitations
on them. Further, we are proposing to amend Sec. 422.100(a) and (c)(1)
to include additional telehealth benefits in the definition of basic
benefits and add a cross-reference to new Sec. 422.135 to reflect how
these benefits may be provided as part of basic benefits. Finally, we
are proposing to amend the bidding regulations at Sec. Sec. 422.252,
422.254, and 422.264 to account for additional telehealth benefits in
the basic benefit bid.
Under this proposal, MA plans will be permitted to offer--as part
of the basic benefit package--additional telehealth benefits beyond
what is currently allowable under the original Medicare telehealth
benefit. According to Sec. 422.100(a), MA plans are able to offer
original Medicare telehealth benefits described in existing authority
at section 1834(m) of the Act and Sec. 414.65. We are proposing that
in addition to original Medicare telehealth benefits, MA plans would be
able (but not required) to offer additional telehealth benefits
described in this proposed rule and at section 1852(m) of the Act. In
addition, we propose to continue authority for MA plans to offer
supplemental benefits (that is, benefits not covered by original
Medicare) via remote access technologies and/or telemonitoring for
those services that do not meet the requirements for additional
telehealth benefits, such as the requirement of being covered by Part B
when provided in-person. For instance, an MA plan may offer a
videoconference dental visit to assess dental needs as a supplemental
benefit because services primarily provided for the care, treatment,
removal, or replacement of teeth or structures directly supporting
teeth are not currently covered Part B benefits and thus would not be
allowable as additional telehealth benefits.
We propose to establish regulatory requirements that would allow MA
plans to cover Part B benefits furnished through electronic exchange as
``additional telehealth benefits''--and as part of the basic benefits
defined in Sec. 422.101--instead of separate supplemental benefits. We
believe additional telehealth benefits would increase access to
patient-centered care by giving enrollees more control to determine
when, where, and how they access benefits.
Section 1852(m)(2)(A)(i) of the Act, as added by the Bipartisan
Budget Act of 2018, defines additional telehealth benefits as
services--(1) for which benefits are available under Part B, including
services for which payment is not made under section 1834(m) of the Act
due to the conditions for payment under such section; and (2) that are
identified for the applicable year as clinically appropriate to furnish
using electronic information and telecommunications technology when a
physician (as defined in section 1861(r) of the Act) or practitioner
(described in section 1842(b)(18)(C) of the Act) providing the service
is not at the same location as the plan enrollee (which we refer to as
``through electronic exchange''). In addition, section
1852(m)(2)(A)(ii) of the Act excludes from additional telehealth
benefits any capital and infrastructure costs and investments relating
to such benefits. This statutory definition of ``additional telehealth
benefits'' has guided our proposal.
We are proposing a new regulation at Sec. 422.135 to authorize and
govern the provision of additional telehealth benefits by MA
organizations, consistent with our interpretation of the new statutory
provision. First, we propose definitions for the terms ``additional
telehealth benefits'' and ``electronic exchange'' in proposed
regulation text at Sec. 422.135(a). We propose to define ``additional
telehealth benefits'' as services that meet the following: (1) Are
furnished by an MA plan for which benefits are available under Medicare
Part B but which are not payable under section 1834(m) of the Act; and
(2) have been identified by the MA plan for the applicable year as
clinically appropriate to furnish through electronic exchange. We
propose to define ``electronic exchange'' as ``electronic information
and telecommunications technology'' as this is a concise term for the
statutory description of the means used to provide the additional
telehealth benefits. We are not proposing specific regulation text that
defines or provides examples of electronic information and
telecommunications technology because the technology needed and used to
provide additional telehealth benefits will vary based on the service
being offered. Examples of electronic information and
telecommunications technology (or ``electronic exchange'') may include,
but are not limited to, the following: Secure messaging, store and
forward technologies, telephone, videoconferencing, other internet-
enabled technologies, and other evolving technologies as appropriate
for non-face-to-face communication. We believe this broad and
encompassing approach will allow for technological advances that may
develop in the future and avoid tying the authority in the proposed new
regulation to specific information formats or technologies that
[[Page 54989]]
permit non-face-to-face interactions for furnishing clinically
appropriate services.
We are not proposing specific regulation text defining ``clinically
appropriate,'' rather, we are proposing to implement the statutory
requirement for additional telehealth benefits to be provided only when
``clinically appropriate'' to align with our existing regulations for
contract provisions at Sec. 422.504(a)(3)(iii), which requires each MA
organization to agree to provide all benefits covered by Medicare ``in
a manner consistent with professionally recognized standards of health
care.'' We propose to apply the same principle to additional telehealth
benefits, as additional telehealth benefits must be treated as if they
were benefits under original Medicare per section 1852(m)(5) of the
Act.
The statute limits additional telehealth benefits to those services
that are identified for the applicable year as clinically appropriate
to furnish through electronic exchange. The statute does not specify
who or what entity identifies the services for the year. Therefore, we
are proposing to interpret this provision broadly by not ourselves
specifying the Part B services that an MA plan may offer as additional
telehealth benefits for the applicable year, but instead allowing MA
plans to independently determine which services each year are
clinically appropriate to furnish in this manner. Thus, our proposed
definition of additional telehealth benefits at Sec. 422.135(a)
provides that it is the MA plan (not CMS) that identifies the
appropriate services for the applicable year. We believe that MA plans
are in the best position to identify each year whether additional
telehealth benefits are clinically appropriate to furnish through
electronic exchange. MA plans have a vested interest in and
responsibility for staying abreast of the current professionally
recognized standards of health care, as these standards are
continuously developing with new advancements in modern medicine. As
professionally recognized standards of health care change over time and
differ from practice area to practice area, our proposal is flexible
enough to take those changes and differences into account.
Furthermore, Sec. 422.111(b)(2) requires the MA plan to annually
disclose the benefits offered under a plan, including applicable
conditions and limitations, premiums and cost sharing (such as
copayments, deductibles, and coinsurance) and any other conditions
associated with receipt or use of benefits. MA plans satisfy this
requirement through the Evidence of Coverage, or EOC, document provided
to all enrollees. This disclosure requirement would have to include
applicable additional telehealth benefit limitations. That is, any MA
plan offering additional telehealth benefits must identify the services
that can be covered as additional telehealth benefits when provided
through electronic exchange. We believe that it is through this
mechanism (the EOC) that the MA plan will identify each year which
services are clinically appropriate to furnish through electronic
exchange as additional telehealth benefits.
We solicit comment on this proposed implementation of the statute
and our reasoning. We considered whether CMS should use the list of
Medicare telehealth services payable by original Medicare under section
1834(m) of the Act as the list of services that are clinically
appropriate to be provided through electronic exchange for additional
telehealth benefits. In that circumstance, services on the list could
be considered as clinically appropriate to be provided through
electronic exchange for additional telehealth benefits without
application of the location limitations of section 1834(m) of the Act.
However, we did not believe that is the best means to take full
advantage of the flexibility that Congress has authorized for the MA
program. The list of Medicare telehealth services for which payment can
be made under section 1834(m) of the Act under the original Medicare
program includes services specifically identified by section 1834(m) of
the Act as well as other services added to the Medicare telehealth list
by CMS that meet certain criteria: (1) The services are similar to
services currently on the list such that there are similar roles and
interactions among the beneficiaries and the distant site physicians or
practitioners furnishing the services; or (2) the services are not
similar to services on the current list but are accurately described by
the corresponding code when furnished via telehealth and produce
demonstrated clinical benefit to patients when furnished using a
telecommunications system. We believe these limitations and criteria do
not apply to additional telehealth benefits under new section 1852(m)
of the Act for MA plans.
The statute requires the Secretary to solicit comment on what types
of items and services should be considered to be additional telehealth
benefits. Therefore, we are also soliciting comments on whether we
should place any limitations on what types of Part B items and services
(for example, primary care visits, routine and/or specialty
consultations, dermatological examinations, behavior health counseling,
etc.) can be additional telehealth benefits provided under this
authority.
An enrollee has the right to request additional telehealth benefits
through the organization determination process. If an enrollee is
dissatisfied with the organization determination, then the enrollee has
the right to appeal the decision. We believe these rights help ensure
access to medically necessary services, including additional telehealth
benefits offered by an MA plan as proposed in this rule. In addition,
CMS audits plan performance with respect to timeliness and clinical
appropriateness of organization determinations and appeals.
While the MA plan would make the ``clinically appropriate''
decision in terms of coverage of an additional telehealth benefit, we
note that each healthcare provider must also provide services that are
clinically appropriate. We acknowledge that not all Part B items and
services would be suitable for additional telehealth benefits because a
provider must be physically present in order to properly deliver care
in some cases (for example, hands-on examination, administering certain
medications). Behavioral health, in particular, is a prime example of a
service that could be provided remotely through MA plans' offering of
additional telehealth benefits under this proposal. The President's
Commission on Combating Drug Addiction and the Opioid Crisis recommends
telehealth as useful in the effort to combat the opioid crisis,
especially in geographically isolated regions and underserved areas
where people with opioid use disorders and other substance use
disorders may benefit from remote access to needed treatment.\3\
---------------------------------------------------------------------------
\3\ https://www.whitehouse.gov/sites/whitehouse.gov/files/images/Meeting%20Draft%20of%20Final%20Report%20-%20November%201%2C%202017.pdf.
---------------------------------------------------------------------------
We are proposing in paragraph (b) the general rule to govern how an
MA plan may offer additional telehealth benefits. Specifically, we
propose that if an MA plan chooses to furnish additional telehealth
benefits, the MA plan may treat these benefits as basic benefits
covered under the original Medicare fee-for-service program as long as
the requirements of proposed Sec. 422.135 are met. We also propose in
Sec. 422.135(b) that if the MA plan fails to comply with the
requirements of Sec. 422.135, then the MA plan may not treat the
benefits provided through electronic exchange as additional telehealth
benefits, but may
[[Page 54990]]
treat them as supplemental benefits. For example, a non-Medicare
covered service provided through electronic exchange cannot be offered
as an additional telehealth benefit because it does not comply with
Sec. 422.135, which is limited to furnishing through electronic
exchange otherwise covered Part B covered services, but it may be
offered it as a supplemental benefit.
Section 1852(m)(4) mandates that enrollee choice is a priority. If
an MA plan covers a Part B service as an additional telehealth benefit,
then the MA plan must also provide access to such service through an
in-person visit and not only as an additional telehealth benefit. We
propose to codify this statutory mandate preserving enrollee choice in
regulation text at Sec. 422.135(c)(1), which would require that the
enrollee must have the option to receive a service that the MA plan
would cover as an additional telehealth benefit either through an in-
person visit or through electronic exchange. Section 1852(m)(5) of the
Act mandates that additional telehealth benefits shall be treated as if
they were benefits under the original Medicare fee-for-service program
option. Based on the manner in which CMS currently allows differential
cost sharing under MA plans for original Medicare-covered benefits, in
proposed regulation text at Sec. 422.135(f), we propose to allow MA
plans to maintain different cost sharing for the specified Part B
service(s) furnished through an in-person visit and the specified Part
B service(s) furnished through electronic exchange. This aligns with
how CMS has traditionally interpreted section 1852(a)(1)(B)(i), (iii),
(iv), and (v) of the Act to mean that, subject to specific exceptions
in the statute and Sec. 422.100(j), basic benefits must be covered at
an actuarially equivalent level of cost sharing from a plan level (that
is, an aggregate and not enrollee level) perspective.
In proposed regulation text at Sec. 422.135(c)(2), we propose to
require MA plans to use their EOC (at a minimum) to advise enrollees
that they may receive the specified Part B service(s) either through an
in-person visit or through electronic exchange. Similarly, as we
propose at Sec. 422.135(c)(3), MA plans would have to use their
provider directory to identify any providers offering services for
additional telehealth benefits and in-person visits or offering
services exclusively for additional telehealth benefits. We believe
that these notifications in the EOC and the provider directory are
important to ensure choice, transparency, and clarity for enrollees who
might be interested in taking advantage of additional telehealth
benefits. We request comments on what impact, if any, additional
telehealth benefits should have on MA network adequacy policies.
Specifically, we will look for the degree to which additional
telehealth benefit providers should be considered in the assessment of
network adequacy (including for certain provider types and/or services
in areas with access concerns) and any potential impact on rural MA
plans, providers, and/or enrollees.
Section 1852(m)(3) of the Act requires the Secretary to specify
limitations or additional requirements for the provision or furnishing
of additional telehealth benefits, including requirements with respect
to physician or practitioner qualifications, factors necessary for the
coordination of additional telehealth benefits with other items and
services (including those furnished in-person), and other areas
identified by the Secretary. We recognize the potential for additional
telehealth benefits to support coordinated health care and increase
access to care in both rural and urban areas. We expect MA plans will
use these types of benefits to support an effective, ongoing doctor-
patient relationship and the efficient delivery of needed care.
We propose in regulation text at Sec. 422.135(c)(4) to require an
MA plan offering additional telehealth benefits to comply with the
provider selection and credentialing requirements provided in Sec.
422.204. An MA plan must have written policies and procedures for the
selection and evaluation of providers and must follow a documented
process with respect to providers and suppliers, as described in Sec.
422.204. Further, we propose that the MA plan, when providing
additional telehealth benefits, must ensure through its contract with
the provider that the provider meet and comply with applicable state
licensing requirements and other applicable laws for the state in which
the enrollee is located and receiving the service. We recognize,
however, that it is possible for a state to have specific provisions
regarding the practice of medicine using electronic exchange; our
intent is to ensure that MA network providers comply with these laws
and that MA organizations ensure compliance with such laws and only
cover additional telehealth benefits provided in compliance with such
laws. We solicit comment on whether to impose additional requirements
for qualifications of providers of additional telehealth benefits, and
if so, what those requirements should be.
In order to monitor the impact of the additional telehealth
benefits on MA plans, providers, enrollees, and the MA program as a
whole, we also propose to require MA plans to make information about
coverage of additional telehealth benefits available to CMS upon
request, per our proposed regulation text at Sec. 422.135(c)(5). We
propose that this information may include, but is not limited to,
statistics on use or cost of additional telehealth benefits, manner(s)
or method(s) of electronic exchange, evaluations of effectiveness, and
demonstration of compliance with the requirements in proposed
regulation text at Sec. 422.135. The purpose of requiring MA plans to
make such information available to CMS upon request is to determine
whether CMS should make improvements to the regulation and/or guidance
regarding additional telehealth benefits.
In proposed regulation text at Sec. 422.135(d), we propose to
require that MA plans furnishing additional telehealth benefits may
only do so using contracted providers. We believe limiting service
delivery of additional telehealth benefits to contracted providers
offers MA enrollees access to these covered services in a manner more
consistent with the statute because plans would have more control over
how and when they are furnished. Additionally, MA plans' must have
written policies and procedures for the selection and evaluation of
providers. These policies must conform with MA credentialing
requirements described in Sec. 422.204. These policies would also
provide additional oversight of providers' performance, increasing
plans' ability to provide covered services such as additional
telehealth benefits. We also propose to specify that if an MA plan
covers benefits furnished by a non-contracted provider through
electronic exchange, then those benefits may only be covered as a
supplemental benefit, not an additional telehealth benefit (that is,
not covered as a basic benefit). We request comment on whether the
contracted providers' restriction should be placed on all MA plan types
or limited only to certain plan types, such as local/regional preferred
provider organization (PPO) plans, medical savings account (MSA) plans,
and/or private fee-for-service (PFFS) plans. Currently, pursuant to
Sec. 422.4(a)(1)(v), PPO plans must provide reimbursement for all
plan-covered medically necessary services received from non-contracted
providers without prior authorization requirements. Without an
opportunity to review the qualifications of the non-contracted
[[Page 54991]]
provider and to impose limits on how only clinically appropriate
services are provided as additional telehealth benefits, PPO plans will
not be able to meet the requirements in this proposed rule. Therefore,
we are soliciting comment on whether to require just PPOs (and/or MSA
plans, PFFS plans, etc.), instead of all MA plan types, to use only
contracted providers for additional telehealth benefits.
Per section 1852(m)(2)(A)(ii) of the Act, the term ``additional
telehealth benefits'' does not include capital and infrastructure costs
and investments relating to such benefits. We propose to codify this
requirement in Sec. 422.254(b)(3)(i) as a restriction on how MA
organizations include additional telehealth benefits in their bid
submission. We believe that the statutory limit is tied only to the
cost to the government of permitting coverage of these additional
telehealth benefits as part of the bid for basic benefits. We are not
proposing specific definitions of capital and infrastructure costs or
investments related to such benefits at this time because the costs and
investments needed and used to provide additional telehealth benefits
will vary based on the individual MA plan's approach to furnishing the
benefits and the MA plan's contracts with providers. Some examples of
capital and infrastructure costs include, but are not limited to, high-
speed internet installation and service, communication platforms and
software, and video conferencing equipment. We are soliciting comments
on what other types of capital and infrastructure costs and investments
should be excluded from the bid and how CMS should operationalize this
statutory requirement in the annual bid process. We propose to provide
a more detailed list of examples in the final rule, based on feedback
received from stakeholders.
In Sec. 422.254(b)(3)(i), we propose that MA plans must exclude
any capital and infrastructure costs and investments relating to
additional telehealth benefits from their bid submission, for both
additional telehealth services offered directly by the plan sponsor and
services rendered by a third party provider. Accordingly, the projected
expenditures in the MA bid for services provided via additional
telehealth benefits must not include the corresponding capital and
infrastructure costs. Any items provided to the enrollee in the
administration of additional telehealth benefits must be directly
related to the care and treatment of the enrollee for the Part B
benefit. For example, MA plans may not provide enrollees with items
such as internet service or permanently install telecommunication
systems in an enrollee's home as part of administration of additional
telehealth benefits.
In addition to our proposal at Sec. 422.135, we also propose to
amend paragraphs (a) and (c)(1) of Sec. 422.100 to explicitly address
how additional telehealth benefits may be offered by an MA plan.
Section 1852(a)(1)(A) of the Act requires that each MA plan shall
provide enrollees benefits under the original Medicare fee-for-service
program option. As amended by the Bipartisan Budget Act of 2018,
section 1852(a)(1)(B) of the Act defines ``benefits under the original
Medicare fee-for-service program option'' to mean--subject to
subsection (m) (regarding provision of additional telehealth
benefits)--those items and services (other than hospice care or
coverage for organ acquisitions for kidney transplants) for which
benefits are available under Parts A and B to individuals entitled to
benefits under Part A and enrolled under Part B. Since this definition
is subject to the statutory provision for additional telehealth
benefits, this means that all of the same coverage and access
requirements that apply with respect to basic benefits also apply to
any additional telehealth benefits an MA plan may choose to offer.
Therefore, we propose to amend Sec. 422.100(c)(1) to include
additional telehealth benefits in the definition of basic benefits and
to cross-reference the proposed regulation at Sec. 422.135 that
provides the rules governing additional telehealth benefits. We also
propose to further clarify the regulation text in Sec. 422.100(c)(1)
to track the statutory language described earlier more closely in
addressing both kidney acquisition and hospice in the definition of
basic benefits. Finally, we propose to make corresponding technical
revisions to Sec. 422.100(a) to reference the new paragraph (c)(1) for
basic benefits (clarifying that additional telehealth benefits are
voluntary benefits for MA plans to offer--not required) and paragraph
(c)(2) for supplemental benefits (instead of Sec. 422.102 because
supplemental benefits are listed as a benefit type in (c)(2)). We also
propose a small technical correction in the last sentence of Sec.
422.100(a) to replace the reference to Sec. 422.100(g) with ``this
section'' because there are a number of provisions in Sec. 422.100--
not just paragraph (g)--that are applicable to the benefits CMS
reviews.
Additionally, we propose amendments to the bidding regulations at
Sec. Sec. 422.252, 422.254, and 422.264 to account for additional
telehealth benefits and correct the inconsistent phrasing of references
to basic benefits (for example, these regulations variously use the
terms ``original Medicare benefits,'' ``benefits under the original
Medicare program,'' ``benefits under the original Medicare FFS program
option,'' etc.). In order to make the additional telehealth benefits
part of the basic benefit bid and included in the ``monthly aggregate
bid amount'' as part of the original Medicare benefits that are the
scope of the basic benefit bid, we propose to update these various
phrases to consistently use the phrase ``basic benefits as defined in
Sec. 422.100(c)(1).'' We also propose a few minor technical
corrections to the bidding regulations. Finally, we propose a paragraph
(e) in new Sec. 422.135 to state that an MA plan that fully complies
with Sec. 422.135 may include additional telehealth benefits in its
bid for basic benefits in accordance with Sec. 422.254. This provision
means that inclusion in the bid is subject to the bidding regulations
we are also proposing to amend here.
In offering additional telehealth benefits, MA plans must comply
with existing MA rules, including, but not limited to: Access to
services at Sec. 422.112; enrollee recordkeeping at Sec. 422.118 (for
example, confidentiality, accuracy, timeliness); standards for
communications and marketing at Sec. 422.2268 (for example, inducement
prohibition); and non-discrimination at Sec. Sec. 422.100(f)(2) and
422.110(a). Further, in addition to Sec. Sec. 422.112, 422.118,
422.2268, 422.100(f)(2), and 422.110(a), MA plans must also ensure
compliance with other federal non-discrimination laws, such as Title VI
of the Civil Rights Act, section 504 of the Rehabilitation Act, and
section 1557 of the Affordable Care Act. We are not proposing specific
reference to these existing requirements in new Sec. 422.135 because
we do not believe that to be necessary. Compliance with these existing
laws is already required; we merely note, as an aide to MA
organizations, how provision of additional telehealth benefits must be
consistent with these regulations. We solicit comment on this policy
choice, specifically whether there are other existing regulations that
CMS should revise to address their application in the context of
additional telehealth benefits.
Finally, section 1852(m)(2)(B) of the Act instructs the Secretary
to solicit comments on the implementation of these additional
telehealth benefits by November 30, 2018; in addition to proposing
regulations to implement section 1852(m) of the Act, we are using this
notice of proposed rulemaking and the associated comment period to
satisfy this statutory requirement. We thank
[[Page 54992]]
commenters in advance for their input to help inform CMS's next steps
related to implementing the additional telehealth benefits.
2. Dual Eligible Special Needs Plans
Special needs plans (SNPs) are MA plans created by the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L.
108-173) that are specifically designed to provide targeted care and
limit enrollment to special needs individuals. Under the law, SNPs are
able to restrict enrollment to: (1) Institutionalized individuals, who
are defined in Sec. 422.2 as those residing or expecting to reside for
90 days or longer in a long term care facility; (2) individuals
entitled to medical assistance under a state plan under Title XIX; or
(3) other individuals with certain severe or disabling chronic
conditions who would benefit from enrollment in a SNP. As of June 2018,
the CMS website listed 297 SNP contracts with 641 SNP plans that have
at least 11 members. These figures included 190 Dual Eligible SNP
contracts (D-SNPs) with 412 D-SNP plans with at least 11 members, 49
Institutional SNP contracts (I-SNPs) with 97 I-SNP plans with at least
11 members, and 58 Chronic or Disabling Condition SNP contracts (C-
SNPs) with 132 C-SNP plans with at least 11 members. This proposed rule
would implement the provisions of the Bipartisan Budget Act of 2018
that establish new requirements for D-SNPs for the integration of
Medicare and Medicaid benefits and unification of Medicare and Medicaid
grievance and appeals procedures that would be effective in 2021. This
proposed rule would also clarify definitions and operating requirements
for D-SNPs that would take effect on the effective date of the final
rule.
a. Integration Requirements for Dual Eligible Special Needs Plans
(Sec. Sec. 422.2, 422.60, 422.102, 422.107, 422.111, and 422.752)
Beneficiaries who are dually eligible for both Medicare and
Medicaid can face significant challenges in navigating the two
programs, which include separate or overlapping benefits and
administrative processes. Fragmentation between the two programs can
result in a lack of coordination for care delivery, potentially
resulting in--(1) missed opportunities to provide appropriate, high-
quality care and improve health outcomes, and (2) ineffective care,
such as avoidable hospitalizations and a poor beneficiary experience of
care. Advancing policies and programs that integrate care for dual
eligible individuals is one way in which we seek to address such
fragmentation. Under plans that offer integrated care, dually eligible
beneficiaries receive the full array of Medicaid and Medicare benefits
through a single delivery system, thereby improving care coordination,
quality of care, beneficiary satisfaction, and reducing administrative
burden. Some studies have shown that highly integrated managed care
programs perform well on quality of care indicators and enrollee
satisfaction.\4\
---------------------------------------------------------------------------
\4\ See: Kim, H., Charlesworth, C.J., McConnell, K.J.,
Valentine, J.B., and Grabowski, DC (2017, November 15). Comparing
Care for Dual-Eligibles Across Coverage Models: Empirical Evidence
From Oregon. Retrieved from http://journals.sagepub.com/doi/abs/10.1177/1077558717740206; Anderson, W.L., Feng, Z., & Long, S.K.
(2016, March 31). Minnesota Managed Care Longitudinal Data Analysis,
prepared for the U.S. Department of Health and Human Services
Assistant Secretary for Planning and Evaluation (ASPE). Retrieved
from https://aspe.hhs.gov/report/minnesota-managed-care-longitudinal-data-analysis; Health Management Associates (2015, July
21). Value Assessment of the Senior Care Options (SCO) Program.
Retrieved from http://www.mahp.com/wp-content/uploads/2017/04/SCO-White-Paper-HMA-2015_07_20-Final.pdf; and Medicare Payment Advisory
Committee (2012, June 16). ``Care coordination programs for dual-
eligible beneficiaries.'' In June 2012 Report to Congress: Medicare
and Health Care Delivery System. Retrieved from http://www.medpac.gov/docs/default-source/reports/chapter-3-appendixes-care-coordination-programs-for-dual-eligible-beneficiaries-june-2012-report-.pdf?sfvrsn=0.
---------------------------------------------------------------------------
D-SNPs are a type of MA plan that is intended to integrate or
coordinate care for this population more effectively than standard M A
plans or Original Medicare by focusing enrollment and care management
on dually eligible individuals. As of June 2018, approximately 2.3
million dually eligible beneficiaries (one 1 of every 6 dually eligible
beneficiaries) were enrolled in 412 D-SNPs. About 170,000 dually
eligible beneficiaries are enrolled in fully integrated dual eligible
special needs plans, or FIDE SNPs (that is, where the same organization
receives capitation to cover both Medicare and Medicaid services).\5\
Several states, including Arizona, Idaho, Hawaii, Massachusetts,
Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Tennessee,
Texas, Virginia, and Wisconsin, operate Medicaid managed care programs
for dually eligible individuals in which the state requires that the
Medicaid managed care organizations serving dual eligible individuals
offer a companion D-SNP product.
---------------------------------------------------------------------------
\5\ Centers for Medicare & Medicaid Services (2018, June). SNP
Comprehensive Report. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.
---------------------------------------------------------------------------
Since the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) first authorized D-SNPs' creation,
subsequent legislation has been enacted that has extended their
authority to operate and set forth additional programmatic
requirements.
Sections 164 and 165 of the Medicare Improvements for
Patients and Providers Act (MIPPA) (Pub. L. 110-275) amended sections
1859 and 1852(a) of the Act to require D-SNPs to--
Provide each prospective enrollee, prior to enrollment,
with a comprehensive written statement that describes the benefits and
cost-sharing protections to which the beneficiary is entitled under
Medicaid and which are covered by the plan;
Contract with the state Medicaid agency to provide
benefits, or arrange for the provision of Medicaid benefits, which may
include long-term care services consistent with state policy, to which
such individual is entitled. Notwithstanding this requirement, section
164(c)(4) of MIPPA stipulated that a state is in no way obligated to
contract with a D-SNP; and
Limit the imposition of cost-sharing on full-benefit dual
eligible individuals and Qualified Medicare Beneficiaries.
Section 3205 of the Patient Protection and Affordable Care
Act (Pub. L. 111-148) revised section 1853(a)(1)(B) of the Act to
permit the Secretary to apply a frailty payment under PACE payment
rules to certain D-SNPs that are fully integrated with capitated
contracts with states for Medicaid benefits, including long-term care,
and that have similar average levels of frailty (as determined by the
Secretary) as the PACE program.
Regulations promulgated following the enactment of these laws
established provisions that:
Define at Sec. 422.2 a fully integrated special needs
plan (FIDE SNP);
Require at Sec. 422.107 all MA organizations seeking to
offer a D-SNP to enter into a contract containing a minimum set of
terms and conditions with the state Medicaid agency;
Require at Sec. 422.111(b)(2)(iii) D-SNPs to furnish,
prior to enrollment, certain benefit and cost-sharing information to
dually eligible enrollees; and
Permit at Sec. 422.308(c)(4) the application of a frailty
payment adjustment to FIDE SNPs that have a similar average level of
frailty (as determined by the Secretary) as the PACE program.\6\
---------------------------------------------------------------------------
\6\ See 73 FR 54226 (September 18, 2008) and 76 FR 21432 (April
15, 2011)
---------------------------------------------------------------------------
[[Page 54993]]
Because the current regulations establish only minimum
requirements, state Medicaid agencies may exercise authority to
establish requirements that surpass the minimum, and to that end, we
have seen states leverage their contracts with D-SNPs to limit D-SNP
enrollment to individuals who also receive Medicaid benefits through
the same organization, collect certain data from the D-SNP, and
integrate beneficiary communication materials and care management
processes to provide dual eligible enrollees a more seamless,
coordinated experience of care.\7\ CMS supports states that have an
interest in pursuing integrated care models for dual eligible
individuals, including through the use of their contracts with MA
organizations offering D-SNPs, and currently provides technical
assistance to states seeking to develop solutions tailored to their
local market conditions, beneficiary characteristics, and policy
environment.
---------------------------------------------------------------------------
\7\ Verdier, J, Kruse, A., Sweetland Lester, R., Philip, A.M., &
Chelminsky, D. (2016, November). ``State Contracting with Medicare
Advantage Dual Eligible Special Needs Plans: Issues and Options.''
Retrieved from http://www.integratedcareresourcecenter.com/PDFs/ICRC_DSNP_Issues__Options.pdf.
---------------------------------------------------------------------------
Through this proposed rule, we are establishing new requirements in
accordance with section 50311(b) of the Bipartisan Budget Act of 2018,
which amended section 1859 of the Act to require that all D-SNPs meet
certain new minimum criteria for Medicare and Medicaid integration for
2021 and subsequent years. Beyond the newly enacted amendments to the
Act, we are also using this rulemaking to add requirements and
clarifications to existing regulations to codify guidance and policy
since D-SNPs were established nearly 15 years ago and to update certain
aspects of the regulations. Under the newly enacted section
1859(f)(8)(D)(i) of the Act, the statute calls for D-SNPs, for 2021 and
subsequent years, to meet one or more of three specified requirements,
to the extent permitted under state law, for integration of benefits:
A D-SNP must, in addition to meeting the existing
requirement of contracting with the state Medicaid agency under section
1859(f)(3)(D) of the Act, coordinate long-term services and supports
(LTSS), behavioral health services, or both, by meeting an additional
minimum set of requirements for integration established by the
Secretary based on input from stakeholders. Such requirements for
integration could include: (1) Notifying the state in a timely manner
of hospitalizations, emergency room visits, and hospital or nursing
home discharges of enrollees; (2) assigning one primary care provider
for each enrollee; or (3) data sharing that benefits the coordination
of items and services under Medicare and Medicaid.
A D-SNP must either--(1) meet the requirements of a fully
integrated dual eligible special needs plan described in section
1853(a)(1)(B)(iv)(II) of the Act (other than the requirement that the
plan have similar average levels of frailty as the PACE program); or
(2) enter into a capitated contract with the state Medicaid agency to
provide LTSS, behavioral health services, or both.
The parent organization of a D-SNP that is also the parent
organization of a Medicaid managed care organization providing LTSS or
behavioral services must assume ``clinical and financial
responsibility'' for benefits provided to beneficiaries enrolled in
both the D-SNP and Medicaid managed care organization.
Section 50311(b) of the Bipartisan Budget Act of 2018 also
authorizes the Secretary, in section 1859(f)(8)(D)(ii) of the Act, to
impose an enrollment sanction on MA organizations offering a D-SNP that
fails to meet at least one of these integration standards in plan years
2021 through 2025. In the event that the Secretary imposes such a
sanction, the MA organization must submit to the Secretary a plan
describing how it will come into compliance with the integration
standards.
(1) Definitions of a ``Dual Eligible Special Needs Plan'', ``Fully
Integrated Dual Eligible Special Needs Plan'', ``Highly Integrated Dual
Eligible Special Needs Plan'', and ``Aligned Enrollment'' (Sec. 422.2)
We are proposing new definitions for the terms ``dual eligible
special needs plan,'' ``fully integrated dual eligible special needs
plan,'' ``highly integrated dual eligible special needs plan,'' and
``aligned enrollment,'' for purposes of part 422 (that is, the rules
applicable to the MA program) and this proposed rule.
Through this notice of proposed rulemaking, we propose to
consolidate statutory and regulatory references to a D-SNP and, in so
doing, clearly state in Sec. 422.2 the minimum requirements for a D-
SNP. Currently, D-SNPs are described in various sections of 42 CFR part
422, including provisions governing the definition of specialized MA
plans for special needs individuals in Sec. 422.2, the supplemental
benefit authority for D-SNPs that meet a high standard of integration
and minimum performance and quality-based standards in Sec.
422.102(e), state Medicaid agency contracting requirements in Sec.
422.107, and specific benefit disclosure requirements in Sec.
422.111(b)(2)(iii). In our proposed definition at Sec. 422.2, we
describe a dual eligible special needs plan as a type of specialized MA
plan for individuals who are eligible for Medicaid under Title XIX of
the Act that provides, as applicable, and coordinates the delivery of
Medicare and Medicaid services, including LTSS and behavioral health
services, for individuals who are eligible for such services; has a
contract with the state Medicaid agency consistent with Sec. 422.107
that meets the minimum requirements in paragraph (c) of such section;
and satisfies at least one of following integration requirements: (1)
It meets the additional state Medicaid agency contracting requirement
at proposed Sec. 422.107(d) (described in section II.A.2.a.(2)) of
this proposed rule that surpasses the minimum requirements in current
regulations at Sec. 422.107(c); (2) it is a highly integrated dual
eligible special needs plan (HIDE SNP), as described in further detail
later in this section; or (3) it is FIDE SNP. In addition, we propose
elsewhere in this proposed rule additional performance requirements for
D-SNPs that we have not incorporated into the definition; for example,
a D-SNP would provide assistance to individuals filing a grievance or
appeal for a Medicaid services in accordance with proposed Sec.
422.562(a)(5) (described in section II.A.2.b.(1) of this proposed
rule).
While we do not explicitly cite or summarize the integration
requirement at section 1859(f)(8)(D)(i)(III) of the Act in this
proposed regulatory definition, we interpret the statutory language on
assuming clinical and financial responsibility for benefits (as
discussed later in this proposed rule) to mean that such a D-SNP would
always satisfy the requirement of being a FIDE SNP or HIDE SNP. We
believe that this proposed definition identifies the minimum
requirements for an MA plan to be a D-SNP under section 1859 of the Act
as amended by the Bipartisan Budget Act of 2018, as well as clarifies
the applicability of the separate regulatory provisions that establish
these minimum standards. We solicit comment whether our proposed
definition meets these goals or should be revised to include other
regulatory provisions that establish requirements for D-SNPs.
We believe it is important to clarify through this rulemaking the
meaning of the requirement in section 1859(f)(3)(D) of the Act, which
is currently codified at Sec. 422.107(b), that the MA organization
have responsibility under the contract for providing benefits or
[[Page 54994]]
arranging for benefits to be provided for individuals entitled to
Medicaid. We have not interpreted the meaning of this statutory
language, ``arranging for benefits,'' in previous rulemaking or in
subregulatory guidance. We propose to interpret ``arranging for
benefits'' as requiring a D-SNP, at a minimum, to coordinate the
delivery of Medicare and Medicaid benefits. We propose to relocate this
requirement to our proposed D-SNP definition. While our interpretation
is consistent with the new statutory integration standards, this
clarification is based on requirements for D-SNPs that existed prior to
the enactment of the Bipartisan Budget Act of 2018 that we believe
should be strengthened. We believe coordination would encompass a wide
range of activities that a D-SNP may engage in for their dual eligible
members. For example, if a D-SNP identifies through an enrollee's
health risk assessment and/or individualized care plan, as required by
Sec. 422.101(f), functional limitations or mental health needs, the D-
SNP would verify the enrollee's eligibility for LTSS and/or behavioral
health services under Medicaid; determine how the enrollee receives
such services (through FFS Medicaid or through another Medicaid managed
care product); and make arrangements with the applicable Medicaid
program (state Medicaid agency or managed care plan) for the provision
of such services by the appropriate payer and/or provider. We recognize
that not all of a D-SNP's membership will be eligible for the full
complement of Medicaid services, particularly those who are partial-
benefit dual eligible individuals whose Medicaid eligibility is limited
to payment of their Medicare premiums, and if applicable, deductibles
and cost-sharing.\8\ However, for all enrollees who are eligible for
Medicaid services, the D-SNP must fulfill its statutory responsibility
to arrange for the provision of Medicaid benefits by facilitating a
beneficiary's meaningful access to such benefits. We believe it would
be insufficient for a D-SNP to limit its coordination activity simply
to telling a beneficiary to call or write their Medicaid managed care
plan or state agency without giving specific contact information,
giving specific coaching on the roles of the Medicaid program (that is,
the state agency or Medicaid managed care plan versus the D-SNP), and
offering additional support if needed. We solicit comment on whether
our proposed definition should be more prescriptive in identifying
which plan activities constitute coordination or whether it should
remain broadly defined as proposed.
---------------------------------------------------------------------------
\8\ Partial-benefit dual eligible programs are commonly referred
to collectively as the ``Medicare Savings Program'' (MSP). The MSP
includes 4 eligibility groups: Qualified Medicare Beneficiary
Program without other Medicaid (QMB Only) for whom Medicaid pays
their Medicare Part A premiums, if any, Medicare Part B premiums,
and to the extent consistent with the Medicaid State plan, Medicare
Part A and B deductibles, coinsurance and copays for Medicare
services provided by Medicare providers; Specified Low-Income
Medicare Beneficiary Program without other Medicaid (SLMB Only) and
Qualifying Individual (QI) Program for whom Medicaid pays the Part B
premiums; Qualified Disabled and Working Individual (QDWI) Program
for whom Medicaid pays the Part A premiums.
---------------------------------------------------------------------------
We propose revising the definition of fully integrated dual
eligible special needs plan at Sec. 422.2 to align with the proposed
definition of a D-SNP and to codify current policy. Specifically, we
propose the following:
Striking the reference to a ``CMS approved MA-PD'' plan in
the current FIDE SNP definition and paragraph (1), which refers to the
individuals eligible for enrollment in a FIDE SNP, because those
provisions duplicate elements of the new proposed definition of a D-SNP
at Sec. 422.2;
Replacing the reference to ``dual eligible beneficiaries''
with ``dual eligible individuals'' in newly redesignated paragraph (1)
to align with the terminology used in section 1935(c) of the Act;
Adding to newly redesignated paragraph (2) that a FIDE
SNP's capitated contract with a state Medicaid agency may include
specified behavioral health services, as well as replacing the term
``long-term care'' benefits with ``long-term services and supports'' to
better describe the range of such services FIDE SNPs cover in capitated
contracts with states. We also propose codifying in paragraph (2) the
current policy that the FIDE SNP's capitated contract with the state
provide coverage of nursing facility services for at least 180 days
during the plan year; \9\
---------------------------------------------------------------------------
\9\ Following the April 2, 2012 issuance of the ``Announcement
of Calendar Year (CY) 2013 Medicare Advantage Capitation Rates and
Medicare Advantage and Part D Payment Policies and Final Call
Letter,'' Chapter 16b of the Medicare Managed Care Manual was
revised to include this policy.
---------------------------------------------------------------------------
Striking references to coordination of covered Medicare
and Medicaid ``health and long-term care'' and referring more broadly
to Medicare and Medicaid services in in newly redesignated paragraph
(3); and
Replacing the reference to ``member'' materials with
``beneficiary communication materials,'' consistent with the definition
of ``communication materials'' at Sec. 422.2260.
We propose to codify a definition of highly integrated dual
eligible special needs plan (HIDE SNP) at Sec. 422.2. Under the
proposed definition, a HIDE SNP would be a type of D-SNP offered by an
MA organization that has--or whose parent organization or another
entity that is owned and controlled by its parent organization has--a
capitated contract with the Medicaid agency in the state in which the
D-SNP operates that includes coverage of LTSS, behavioral health
services, or both, consistent with state policy.
We note that all the requirements of a D-SNP would also apply to a
HIDE SNP, such as the obligation to provide, as applicable, and
coordinate Medicare and Medicaid benefits. In contrast to a FIDE SNP, a
D-SNP could satisfy the requirements of a HIDE SNP if its parent
organization offered a companion Medicaid product that covered only
LTSS or behavioral health services, or both, under a capitated
contract. Because a FIDE SNP covers comprehensive Medicaid benefits
including LTSS and behavioral health services, any FIDE SNP would also
be a HIDE SNP, but not all HIDE SNPs would qualify to be FIDE SNPs. In
defining a HIDE SNP, we chose to adopt the phrase ``consistent with
state policy'' to align with the FIDE SNP definition. We interpret this
phrase, both for FIDE SNPs and HIDE SNPs, as an important
acknowledgement of variation in how states elect to provide coverage of
LTSS or behavioral health services under their capitated contracts with
D-SNPs and Medicaid managed care plans (for example, MCOs in the case
of FIDE SNPs, and MCOs, PIHPs, and PAHPs in the case of HIDE SNPs). For
example, one state may include all Medicaid behavioral health services
in its capitated contracts, while another state may carve out a
particular service from its capitated contracts with a Medicaid managed
care plan covering behavioral health services. We interpret the phrase
``consistent with state policy'' as allowing CMS to permit certain
carve-outs where consistent with or necessary to accommodate state
policy, except for where specifically prohibited (such as for nursing
facility services in the FIDE SNP definition). As such, among the
states that have capitated contracts with D-SNPs or the D-SNPs' parent
organizations, CMS can still determine that D-SNPs meet the FIDE SNP or
HIDE SNP definition despite these types of variations allowed under
this proposal. We solicit comment on this proposed definition,
including on whether additional requirements for HIDE SNPs should be
addressed in the definition.
We also propose to establish at Sec. 422.2 a definition for the
term aligned
[[Page 54995]]
enrollment, as many of the other D-SNP proposals in this proposed rule
are based on this concept. Under our proposal, aligned enrollment
occurs when a full-benefit dual eligible individual is a member of a D-
SNP and receives coverage of Medicaid benefits from the D-SNP or from a
Medicaid managed care organization, as defined in section 1903(m) of
the Act, that is: (1) The same organization as the MA organization
offering the D-SNP; (2) its parent organization; or (3) another entity
that is owned and controlled by the D-SNP's parent organization.
Aligned enrollment, as we propose to define it, would not arise where
the MA organization or its parent organization has a contract with the
applicable state to offer a prepaid inpatient health plan (PIHP) or
prepaid ambulatory health plan (PAHP) in the state's Medicaid program.
Unlike a Medicaid MCO, these other Medicaid managed care plans cover
only specific and non-comprehensive set of services. In the event that
it is the policy of the state Medicaid agency to limit a D-SNP's
membership to individuals with aligned enrollment, we would describe
this practice as ``exclusively aligned enrollment,'' which is embedded
in the definition of ``aligned enrollment.'' For example, some states
limit D-SNP enrollment to full-benefit dual eligible individuals who
also choose to receive Medicaid benefits through the D-SNP or a
Medicaid MCO operated by the same entity (that is, by the MA
organization) or by the MA organization's parent organization. Such a
limitation would be included in the state Medicaid agency contract with
the D-SNP. Exclusively aligned enrollment is relevant to how we propose
to apply the integrated grievance and appeals requirements described in
section II.A.2.b. of this proposed rule. We solicit comment on how we
propose to define aligned enrollment given its relevance to the
category of D-SNPs to which the integrated grievance and appeals
procedures apply. We also solicit comment on whether we should consider
other types of Medicaid managed care arrangements beyond companion
Medicaid MCOs, as defined in section 1903(m) of the Act and codified at
Sec. 438.2, operated by a HIDE SNP's parent organization.
Finally, we propose in our definition of a D-SNP at Sec. 422.2 to
codify that an MA organization seeking to offer a D-SNP must satisfy
any one (or more) of the three integration requirements in section
1859(f)(3)(D)(i) of the Act. We note that the statutory language
requires that plans meet one or more statutorily identified integration
requirements to the extent permitted under state law. We interpret this
phrase as acknowledging and respecting the flexibility provided to
states under the Medicaid program while imposing on D-SNPs integration
requirements that Congress has deemed necessary. In approximately 20
states, state law does not permit enrollment of dual eligible
individuals in managed care for Medicaid services, which would
effectively preclude a D-SNP in such a state from being a HIDE SNP
(paragraph 2) or FIDE SNP (paragraph 3). Similarly, in other states,
certain Medicaid benefits, such as LTSS and behavioral health services,
are carved out of Medicaid managed care, which could similarly preclude
a D-SNP from meeting paragraphs (2) or (3) of our proposed definition
of a D-SNP. As we discuss in the context of our definitions of a FIDE
SNP and HIDE SNP, a carve-out by the state of a minimal scope of
services is permissible so long as comprehensive services are covered
under the capitated Medicaid contract. For these reasons, we propose to
interpret this statutory provision in a way that provides multiple
avenues for a MA plan to qualify as a D-SNP. However, we considered
other interpretations of this particular provision. For example, we
considered whether this phrase should mean that in states that have
Medicaid managed care programs for dual eligible individuals, all MA
organizations seeking to offer a D-SNP could do so only if they were
under contract with the state to offer a companion Medicaid managed
care plan in that state, on the grounds that such an opportunity is
permitted under state law. We solicit comments on our proposed
interpretation as well as alternatives. We also request comment on
whether and how our proposed definition could or should be revised
consistent with the interpretation we take of the statute.
These proposed definitions serve to describe different types of D-
SNPs based on the degree to which they integrate Medicaid benefits at
the plan level. FIDE SNPs that limit enrollment to full-benefit dual
eligible individuals and require (or have) exclusively aligned
enrollment across Medicare and Medicaid constitute the most extensive
level of integration, with the greatest potential for holistic and
person-centered care coordination, integrated appeals and grievances,
comprehensive beneficiary communication materials, and quality
improvement. HIDE SNPs with exclusively aligned enrollment are plans
that share much of this potential but integrate a narrower set of
Medicaid benefits than FIDE SNPs. We believe that an entity can only
truly hold ``clinical and financial responsibility'' for the provision
of Medicare and Medicaid benefits, as described at section
1859(f)(8)(D)(i)(III) of the Act, in the scenarios of exclusively
aligned enrollment. Therefore, the plans that meet this criterion would
be FIDE SNPs and HIDE SNPs that have exclusively aligned enrollment, as
these terms are defined under our proposal. By virtue of these
exclusively aligned plans' status as a FIDE SNP or HIDE SNP, they would
also satisfy the integration requirement at section
1859(f)(8)(D)(i)(II) of the Act, which we codified in paragraphs (2)
and (3) of the definition of a D-SNP at Sec. 422.2.
FIDE SNPs and HIDE SNPs where aligned enrollment is possible--but
not required--under the state contract with the D-SNP and the state's
administration of its Medicaid managed care program would constitute
another form of integration, albeit to a lesser degree. In such a D-
SNP, it is likely that some share of the D-SNP's enrollment is aligned
enrollment but not exclusively aligned enrollment. Some dual eligible
individuals enrolled in that plan may: (1) Enroll in a Medicaid managed
care plan operated by a different parent organization; or (2) receive
their Medicaid benefits through Medicaid fee-for-service. These other
choices may be a result of individual choice even when a Medicaid
managed care plan offered by the same entity (or parent organization)
as the MA D-SNP is available or may be the result of the applicable
state's decisions in administering its Medicaid program.
Under section 1859(f)(8)(D)(i) of the Act, those D-SNPs that are
neither FIDE SNPs nor HIDE SNPs must meet an additional state Medicaid
contracting requirement beginning in 2021. Our proposed definition of a
D-SNP addresses this in paragraph (1), cross-referencing the proposed
new requirement in paragraph (d) of Sec. 422.107. This new
requirement, which involves the provision of notice when an individual
who belongs to a group of high-risk dual eligible individuals has a
hospital and skilled nursing facility admission, is discussed in
section II.A.2.b.(2) of the proposed rule in greater detail. We solicit
comments on this proposal and, in particular, on alternative approaches
to classifying D-SNPs consistent with requirements of section
1859(f)(8)(D)(i) of the Act.
[[Page 54996]]
(2) Dual Eligible Special Needs Plans and Contracts With States (Sec.
422.107)
In Sec. 422.107, we propose changes to more clearly articulate the
requirements of the contract between the D-SNP and the state Medicaid
agency, while also incorporating the changes required by the Bipartisan
Budget Act of 2018. In summary, we propose to make the following
changes:
Delete language in paragraph (b) that is extraneous and
duplicative of the proposed definition of a D-SNP in Sec. 422.2;
Make clarifying edits in paragraphs (c)(1) through (c)(3),
which govern the minimum requirements of the contract between the D-SNP
and the state Medicaid agency;
Redesignate paragraph (d) as paragraph (e), which relates
to compliance dates; and
Establish a revised paragraph (d) that describes the new
minimum contracting requirement under the Bipartisan Budget Act of 2018
that the newly designated paragraph (e)(2) would make effective January
1, 2021.
Section 50311(b) of the Bipartisan Budget Act of 2018 amended
section 1859(f) of the Act by creating a new paragraph (8)(D)(i)(I) to
require that the Secretary establish additional requirements for D-
SNPs' contracts with state Medicaid agencies. We address in our
preamble discussion about our proposed definition of D-SNP how this
provision requires a D-SNP to have a state Medicaid agency contract
that includes additional coordination requirements (subsection
(f)(8)(D)(i)(I) of the Act); be a FIDE SNP or HIDE SNP (subsection
(f)(8)(D)(i)(II) of the Act); or have exclusively aligned enrollment
and have its parent organization accept full clinical and financial
responsibility for all Medicare and Medicaid covered services
(subsection (f)(8)(D)(i)(III) of the Act), depending on the state's
election.
We are proposing to implement subsection (f)(8)(D)(i)(I) of the Act
itself by establishing at Sec. 422.107(d) that any D-SNP that is not a
FIDE SNP or HIDE SNP is subject to an additional contracting
requirement. Under this proposed new contract requirement, the D-SNP
would be required to notify the state Medicaid agency, or individuals
or entities designated by the state Medicaid agency, of hospital and
skilled nursing facility (SNF) admissions for at least one group of
high-risk full-benefit dual eligible individuals, as determined by the
state Medicaid agency. Our proposal would also permit the D-SNP to
authorize another entity or entities (such as a D-SNP's network
providers) to notify the state Medicaid agency and/or individuals or
entities designated by the state Medicaid agency on its behalf, with
the understanding that the D-SNP ultimately would retain responsibility
for complying with this requirement. Our intent in proposing this
notification requirement is to promote the integration of Medicare and
Medicaid benefits by establishing a minimum contracting requirement
that has the effect of increasing D-SNPs' care coordination activity
around care transitions. In such care transitions, there is a clear
need to share information among parties concerned with the
beneficiary's care and there is a risk of potential harm to the
beneficiary when effective communication and coordination do not occur.
In our experience, there are known gaps when a beneficiary migrates
from one setting where services are covered under Medicare, such as an
inpatient or SNF stays, to another setting where services such as LTSS,
including home and community based services (HCBS), that are covered
under Medicaid.\10\ This proposed provision is intended to promote
successful transitions of care into a setting of the beneficiary's
choice, and increase coordination among those involved in furnishing
and paying for primary care, acute care, LTSS, and behavioral health
services. The proposed requirement for notification is just one facet
of successful, holistic care transitions, but we believe it is an
essential catalyst for the process.
---------------------------------------------------------------------------
\10\ ``Improving Care Transitions,'' Health Affairs Health
Policy Brief, September 13, 2012. DOI: 10.1377/hpb20120913.327236.
Retrieved from https://www.healthaffairs.org/do/10.1377/hpb20120913.327236/full/; and Segal, M., Rollins, E., Hodges, K.,
and Roozeboom, M. ``Medicare-Medicaid Eligible Beneficiaries and
Potentially Avoidable Hospitalizations.'' Medicare & Medicaid
Research Review, 2014: 4 (1), p. E1-E10. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4053188/pdf/mmrr2014-004-01-b01.pdf.
---------------------------------------------------------------------------
In permitting a state Medicaid agency to specify which
subpopulations of high-risk full-benefit dual eligible individuals the
D-SNP must focus on through this effort, we are seeking to give states
flexibility to begin on the path toward greater integration on a
smaller scale and, in collaboration with the D-SNPs in their markets,
test different approaches. As processes and infrastructure mature, a
state Medicaid agency may choose through its contracts with D-SNPs to
scale up this notification to include additional data, additional
subpopulations of full-benefit dual eligible individuals, or both.
High-risk beneficiaries could include those who are receiving HCBS or
participating in a Medicaid health home program in accordance with
section 1945 of the Act. Alternatively, or in addition, the state
Medicaid agency could use claims or encounter data to target particular
groups, such as those who have a history of hospital readmissions or
who are high utilizers of acute care services, LTSS, or behavioral
health services. Under this proposal, we would give the state Medicaid
agency broad latitude to establish notification procedures and
protocols, including the recipients of the admission notifications,
timeframes by which a D-SNP must furnish this information directly or
indirectly, and how such notification would occur. We are proposing to
defer to state Medicaid agencies on the manner in which notification
occurs, that is, whether it involves an automated or manual process.
For example, in markets where there is existing infrastructure to
leverage, such as a state health information exchange, a state may
elect an approach that requires data sharing across a common platform
using industry standards, including those adopted by the Office of the
National Coordinator for Health IT in accordance with 45 CFR part 170,
subpart B. Regardless of process, the expectation is that notifications
occur timely in order to ensure prompt care coordination and effective
care transitions. To that end, we strongly encourage states to use the
most efficient notification mechanisms available, which may include the
state's health information exchange. However, we appreciate that not
every state is similarly positioned and, therefore, if a state elected
to implement this requirement on a smaller scale, targeting a small
subset of beneficiaries, a solution that does not initially require
automation may be more appropriate and pragmatic. We support state
Medicaid agencies in their efforts to adopt the policies and procedures
for this notification requirement that work best for them and D-SNPs
participating in their markets. Regardless of what approach a state
chooses to take under this proposal, our aim is to have actionable
information that enables providers and payers to facilitate seamless
care transitions for high-risk populations, that is, those full-benefit
dual eligible individuals who are among the most ill and medically
complex or who are most likely to benefit from effective interventions
(such as through the provision of LTSS and behavioral health services)
that enable them to live independently in the setting of their choice
and in a way that values their own needs and preferences.
We believe that our proposal to establish a notification
requirement for D-SNPs for high-risk individuals'
[[Page 54997]]
hospital and skilled nursing facility admissions is consistent with the
criteria we used to evaluate various options for the minimum
contracting requirements. We considered whether a proposal would--
Meaningfully improve care coordination and care
transitions, thereby improving health outcomes for dually eligible
beneficiaries;
Minimize burden on plans and states relative to the
improvements in care coordination and transitions;
Provide flexibility to state Medicaid agencies;
Enable CMS to assess compliance with minimal burden on
CMS, plans, and providers; and
Be consistent with the statutory amendments made by the
Bipartisan Budget Act of 2018.
We solicit comment on whether our proposal satisfies these criteria
to a greater extent than the more prescriptive or alternative proposals
we considered as described in further detail in this section of this
proposed rule; whether our reasoning for why our proposal is preferable
to the more prescriptive or alternative proposals is sound; whether
there are other minimum contacting requirements that we did not
consider that are superior to our proposal; and whether our proposal
provides sufficient incentives for plans and states to pursue greater
levels of integration. For example, we considered the following:
We considered proposing that notice requirements apply for
all full-benefit dual eligible individuals' hospital and SNF
admissions. We believe our proposal is preferable because it limits the
administrative burdens for states and MA organizations and focuses
efforts on high-risk beneficiaries for whom there is likely to be some
Medicaid care coordination infrastructure.
We considered proposing a minimum size for the state-
selected high-risk population. In contrast, our proposal for new Sec.
422.107(d) gives state Medicaid agencies the discretion to decide what
it means that a group of beneficiaries is at high risk and how large or
small the group(s) may be.
We considered requiring a notification for every emergency
department visit, as mentioned in section 1859(f)(8)(D)(i)(I) of the
Act. We believe our proposal is preferable because it focuses on
hospital and SNF admissions where CMS believes there is the greatest
opportunity to target interventions and improve outcomes, and during
which there is more time to initiate discharge planning than during an
emergency department visit. However, we note that a state Medicaid
agency could choose to require a notification for full-benefit dual
eligible individuals who are high utilizers of emergency departments,
where there may be opportunities to address barriers to accessing
primary care and unmet health care needs.
We considered proposing that the notification occur not
later than 48 hours after the D-SNP learns of the admission or
discharge. We opted instead to defer to the state Medicaid agency on
such matters. We believe that states may choose to use this information
for their own purposes, including program oversight; alternatively, or
in addition, a state Medicaid agency may opt to require a direct
notification between the D-SNP and Medicaid managed care organization
(MCO) or a specified Medicaid provider to allow for the timeliest
action following a care transition or other significant event.
We considered focusing on better coordination of
individual health needs assessments and mechanisms to reduce assessment
burden for enrollees. We continue to hear of scenarios where a D-SNP
enrollee is assessed separately by the D-SNP and then again by their
Medicaid MCO, even though there may be a high degree of overlap in what
each organization is assessing and ultimately what each organization is
asking of the enrollee. Because we are unclear on the scope of the
problem, we solicit comment on how pervasive this issue is and the
extent of overlap in the assessment instruments and degree of burden on
providers and beneficiaries. We welcome feedback for our consideration
in the final rule, specifically on the extent to which the requirements
that we propose do not accomplish enough or should be modified to
address this issue. For example, we seek comment on whether a
coordination obligation for D-SNPs should be adopted that could
require, for example, each D-SNP to take affirmative steps to schedule
its assessments at the same time as similar outreach is conducted by
the Medicaid managed care plan, to use a combined or aligned assessment
instrument, or take other steps that would minimize the burden on
enrollees or providers.
We considered requiring D-SNPs to identify any enrollees
who are in need of LTSS and behavioral health services and transmitting
such information to the state Medicaid agency. However, D-SNPs are
already required, at Sec. 422.101(f), to develop individualized care
plans and perform health risk assessments that identify the physical,
psychosocial, and functional needs of each SNP enrollee. We do not wish
to duplicate an existing requirement, but to the extent the current
regulation text is insufficient to accomplish this or additional
regulatory standards for identifying and sharing information are
necessary, we welcome comment on that topic.
We considered requiring D-SNPs to train plan staff and
their network providers on the availability of LTSS and behavioral
health services covered by Medicaid. While we believe that such
awareness, understanding, and training are vitally important to
delivering appropriate care to full-benefit dual eligible individuals,
we also believe that it is an intrinsic administrative function of a D-
SNP in fulfilling its responsibility to coordinate the delivery of
Medicare and Medicaid benefits and therefore potentially duplicative of
existing requirements, including the requirement to train plan staff
and network providers on the D-SNP model of care.
We considered requiring D-SNPs to solicit state input on
the plan's model of care (which is currently required and submitted to
CMS pursuant to Sec. 422.101(f)), health risk assessment instrument,
and beneficiary communication materials. However, we were disinclined
to impose such a requirement on D-SNPs that do not have exclusively
aligned enrollment. Further, in states without capitated arrangements
with D-SNPs for the provision of Medicaid services, Medicaid agencies
may not see a role for themselves in reviewing such documents, and we
did not want such a requirement to create additional burden for states.
State Medicaid Agencies, however, can choose to require that a D-SNP
provide such documents for state input through their contracts with D-
SNPs. We seek comment on whether our assumptions about state burden are
correct and whether there are compelling reasons why additional
contracting requirements in this area may be necessary.
Finally, we considered the merits of requiring D-SNPs to
share data with state Medicaid agencies or entities designated by State
Medicaid Agencies that would benefit the coordination of Medicare and
Medicaid items and services, as described in section
1859(f)(8)(D)(i)(I) of the Act, as an example for implementing that
provision. However, we ultimately decided against proposing such a
requirement here so we can further assess the operational and technical
hurdles and costs for both state Medicaid agencies and D-SNPs. Instead,
[[Page 54998]]
we are proposing to focus initially on establishing the notification
requirement for hospital and SNF admissions, which we believe will lead
to more immediate improvements in the care transitions process.
However, we solicit comment on whether there should be additional
regulatory requirements around data sharing.
We seek feedback on our notification proposal at Sec. 422.107(d),
including the ways that State Medicaid Agencies and plans would fulfill
this requirement, and the additional contracting requirements we
considered, as summarized in this section.
In addition to the new requirement for contracts between the State
and MA organization at proposed Sec. 422.107(d) for D-SNPs that are
not FIDE SNPs or HIDE SNPs, we are proposing to include additional
specifications in the regulations governing D-SNP contracts with State
Medicaid Agencies at Sec. 422.107 by amending paragraph (b) and
several provisions in paragraph (c). We do not believe that these
specifications materially alter these agreements; however, we are
proposing them in response to questions raised since the State Medicaid
agency contracting requirements were promulgated in the September 2008
interim final rule (73 FR 54226). We also believe that these changes
align with the integration requirements for D-SNPs in the Bipartisan
Budget Act of 2018.
We are proposing to modify the general rule for contracts with D-
SNPs at Sec. 422.107(b) to strike ``The MA organization retains
responsibility under the contract for providing benefits, or arranging
for benefits to be provided, for individuals entitled to receive
medical assistance under Title XIX. Such benefits may include long-term
care services consistent with state policy.'' We believe that these
sentences would no longer be necessary to describe the mandatory
content of the contract. Our proposed definition at Sec. 422.2 of ``D-
SNP'' requires the plan to provide, as applicable, and coordinate the
delivery of Medicare and Medicaid services; we believe this is
sufficient for D-SNPs to be aware of the requirement and for CMS to
enforce it.
We propose to revise the contracting requirement at Sec.
422.107(c)(1), which currently requires the contract to document the MA
organization's responsibility, including financial obligations, to
provide or arrange for Medicaid benefits to specify instead that the
contract must document the MA organization's responsibility to provide,
as applicable, and coordinate the delivery of Medicaid benefits,
including LTSS and behavioral health services, for individuals who are
eligible for such services. This proposed revision would clarify that
in some cases, the D-SNP may cover (that is, provide directly or pay
health care providers for providing) Medicaid benefits under a
capitated contract with the State Medicaid agency, but in all cases, it
must coordinate the delivery of Medicaid benefits. In addition to being
codified in our proposed revisions to Sec. 422.107(c)(1), this is
consistent with our proposed definition of ``dual eligible special
needs plan,'' which indicates that each D-SNP ``coordinates the
delivery of Medicare and Medicaid services.'' Current regulations use
the phrase ``providing benefits, or arranging for benefits to be
provided'' but do not describe what it means for D-SNPs to provide or
arrange for Medicaid benefits; we believe this proposed amendment to
impose an affirmative duty to provide benefits, as applicable, and
otherwise coordinate the delivery of benefits clarifies that D-SNPs
must play an active role in helping beneficiaries access such services
as necessary. We further believe that ``coordination'' more aptly
describes the activity in which D-SNPs are engaged with respect to a
beneficiary's Medicaid benefits. We solicit comment on whether our
proposed amendments to this section fully communicate what we intend to
require of D-SNPs or whether there are additional revisions we ought to
consider to express our intent more clearly for D-SNPs, State Medicaid
Agencies, and other stakeholders.
In Sec. 422.107(c)(2), we propose to revise the current
requirement that the contract between the D-SNP and the State Medicaid
Agency document the categories of dual eligible individuals who are
eligible to enroll in the D-SNP. This provision currently requires the
contract to specify whether the D-SNP can enroll categories of partial-
benefit dual eligible individuals or whether enrollment is limited to
full-benefit dual eligible individuals. We are proposing to revise this
requirement to specify not only the categories of eligibility but also
any additional criteria of eligibility to account for such conditions
of eligibility under Medicaid as nursing home level of care and age.
These criteria could also include a requirement for D-SNP enrollees to
enroll in a companion Medicaid plan to receive their Medicaid services.
Finally, at Sec. 422.107(c)(3), we propose that the contract
between the D-SNP and the State Medicaid Agency document the Medicaid
services the D-SNP is responsible for covering in accordance with a
capitated contract with the D-SNP directly or through a risk contract,
defined at Sec. 438.2, with the companion Medicaid managed care
organization operated by the D-SNP's parent organization. We believe
that this change, if finalized as proposed, would reduce burden on D-
SNPs to identify and document in the contract every Medicaid-covered
service. D-SNPs often submit to CMS a list of all Medicaid services in
their State Medicaid Agency contracts, even those for which the D-SNP
is not under a capitated contract and for which the D-SNP bears no
risk. Even with this change, we continue to expect D-SNPs, for purposes
of coordinating their enrollees' Medicaid benefits as required in the
proposed definition of a D-SNP in Sec. 422.2, to know and understand
all services covered in each state's approved state plan, including any
services that may be carved out and covered separately from the D-SNP.
This clarifying change would enable us to identify the particular
Medicaid services that are covered under a capitated contract for FIDE
SNPs and HIDE SNPs, and we seek comment on whether the regulatory
change fully communicates what we wish to require. We intend to issue
sub-regulatory guidance to address any changes made under this
rulemaking that impact D-SNPs contracts with State Medicaid Agencies.
(3) Conforming and Technical Changes (Sec. Sec. 422.60(g), 422.102(e),
422.107(b), and 422.111(b)(2)(iii))
We are also proposing to make conforming changes to several
sections of Part 422 that address D-SNPs by adopting consistent
terminology with respect to dual eligible individuals and creating
cross-references to the newly proposed definitions. First, at Sec.
422.60(g), which addresses CMS authority to implement passive
enrollment, we propose to use the term ``highly integrated dual
eligible special needs plan'' in place of text referring to D-SNPs that
meet a high level of integration. This is consistent with our new
proposed definition in Sec. 422.2. This technical change would not
materially change the plan types that are eligible for passive
enrollment; the existing rule simply refers to them as D-SNPs that meet
a high standard of integration under the supplemental benefit authority
at Sec. 422.102(e). Second, we also propose clarifying at Sec.
422.102(e) that not only HIDE SNPs meeting minimum quality and
performance standards are eligible to offer supplemental benefits, but
FIDE SNPs that similarly meet minimum quality and performance standards
may do so as well. While this amendment does not
[[Page 54999]]
change what has occurred in practice, we believe it clarifies the types
of plans that are eligible to offer enhanced supplemental benefits.
Third, in the general rule at Sec. 422.107(b), we are proposing to
substitute a ``special needs plan serving beneficiaries eligible for
both Medicare and Medicaid (dual-eligible)'' with ``dual eligible
special needs plan.'' Already explicit in the proposed definition of a
D-SNP is that such plans exclusively serve individuals who are eligible
for Medicaid under Title XIX of the Act, and we believe that the
language in the current regulations is extraneous. Finally, at Sec.
422.111(b)(2)(iii), which requires D-SNPs to provide written
information to dual eligible enrollees about their eligibility for
cost-sharing protections and Medicaid benefits, we propose to use the
term ``dual eligible special needs plan'' consistent with the proposed
definition.
(4) Eligibility of Partial-Benefit Dual Eligible Individuals for Dual
Eligible Special Needs Plans
We considered proposing limits on the enrollment of partial-benefit
dual eligible individuals in D-SNPs, since there are no Medicaid
services that the D-SNP is integrating or coordinating on their behalf.
We continue to question the benefit that partial-benefit dual eligible
individuals derive from their enrollment in a D-SNP relative to the
challenges associated with allowing such enrollment. For example,
allowing D-SNPs to enroll both partial- and full-benefit dual eligible
individuals significantly limits the ability of plans, CMS, and states
to simplify beneficiary communications materials. We ultimately decided
against proposing any such limits on enrollment at this time but
continue to consider this issue. We invite comments on this topic.
(5) Suspension of Enrollment for Non-Compliance With D-SNP Integration
Standards (Sec. 422.752)
Section 50311(b) of the Bipartisan Budget Act of 2018 amended
section 1859(f) of the Act by creating a new paragraph (8)(D)(ii) to
permit the Secretary, for plan years 2021 through 2025, to impose an
intermediate sanction of stopping all new enrollment into a D-SNP if
the Secretary determines that the D-SNP is failing to comply with the
integration requirements set forth in section 1859(f)(8)(D)(i) of the
Act. By establishing statutory requirements that established a minimum
level of integration of D-SNPs in section 50311 of the Bipartisan
Budget Act of 2018, we believe the goal was for all dual eligible
beneficiaries enrolled in D-SNPs to receive a greater level of
integration of Medicare and Medicaid benefits than is the case under
current regulations. Because the Bipartisan Budget Act of 2018 limited
the applicability of the Secretary's authority to impose an
intermediate sanction on plans that do not comply with the integration
requirements to plan years 2021 through 2025, we believe that the
intent of this provision is to offer an alternative to outright
contract or plan termination for D-SNPs that fail to meet the new
integration requirements during the period of 2021 through 2025. We
believe the enrollment sanction authority is a lesser penalty than a
contract or plan termination to provide time for D-SNPs to transition
to the new integration requirements without creating potentially
significant disruption to current D-SNP enrollees as a result of
outright termination. In addition to authorizing this lesser sanction,
the statute requires a corrective action plan, which we believe
strengthens our interpretation, as it illustrates a preference for
ultimate compliance by D-SNPs with the integration requirements. As
provided in section 1859(f)(8)(D)(i) of the Act, in the event that such
a sanction is imposed, the plan must submit to the Secretary (at a
time, and in a form and manner, specified by the Secretary) information
describing how the plan will come into compliance with the integration
requirements.
The statute authorizes this lesser sanction but does not require
that it be used, leaving it to our discretion whether an enrollment
sanction combined with a corrective action plan is sufficient to
achieve the goals of the statute. We believe that it would be
appropriate to impose the enrollment sanction for non-compliant D-SNPs
before initiating any contract termination or other sanction or
enforcement action. Therefore, we propose to amend Sec. 422.752 by
adding a new paragraph (d) that would require CMS to impose an
enrollment suspension when CMS finds that the plan is non-compliant
with the integration requirements during plan years 2021 through 2025,
rather than initiating outright termination. While the statute grants
the Secretary discretion to sanction plans that fail to meet the new
integration requirements, starting in 2021, by stopping all new
enrollment into such plans, our proposal would establish predictability
for states, beneficiaries, and MA organizations by requiring its
imposition for non-compliant plans in lieu of termination or other
actions. However, we stress that we interpret this proposal as leaving
discretion for CMS, if the D-SNP does not submit an acceptable
corrective action plan or fails to abide by the correction action plan,
to determine that contract termination or other action is still
possible. In addition, in the event that any harm to enrollees is
imminent, we retain authority to immediately terminate the contract. We
also propose in Sec. 422.752(d) that the suspension of enrollment
would continue in effect until CMS is satisfied that the deficiencies
that are the basis for the sanction determination have been corrected
and are not likely to recur. The procedures, remedies, and appeal
rights available to plans subject to intermediate sanctions provided in
Sec. 422.756 would apply to D-SNPs that are sanctioned under this new
authority.
b. Unified Grievance and Appeals Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed Care Plans at the Plan Level
(Sec. Sec. 422.560-562, 422.566, 422.629-634, 438.210, 438.400, and
438.402)
Section 1859(f)(8)(B) of the Act, as added by the Bipartisan Budget
Act of 2018, directs the Secretary to establish new procedures that
unify, to the extent feasible, Medicare and Medicaid grievance and
appeals procedures for D-SNPs. This new authority provides an important
opportunity to address an area of longstanding misalignment between the
Medicare and Medicaid programs. Medicare and Medicaid grievance and
appeal processes have developed independently and operate entirely
separately. Medicare's fee-for-service appeals processes (authorized
primarily under section 1869 of the Act for Part A and B claims
appeals), and MA's processes (authorized under sections 1852(f) and
1852(g) of the Act for grievance and appeal processes) are subject only
to federal regulation and oversight as part of the federally-
administered Medicare program. Medicaid grievances and appeals are
authorized under sections 1902(a)(3) and 1902(a)(5) of the Act for
Medicaid programs more generally and section 1932(b)(4) of the Act for
Medicaid managed care plans. Unlike Medicare and MA, Medicaid appeals
and grievance procedures are subject to both federal and state
regulation and are primarily subject to state oversight and
administration as part of a joint federal-state financed program.
Medicare Part D grievances and appeals are authorized under sections
1860D-4(f) and (g) of the Act and are outside the scope of our
authority to unify grievances and
[[Page 55000]]
appeals under new section 1859(f)(8)(B) of the Act; we note, however,
that D-SNPs are all required to provide Part D prescription drug
coverage pursuant to Sec. 422.2.
Both the Medicare and Medicaid grievance and appeals systems
include regulations establishing procedures for the fee-for-service
programs as well as regulations governing managed care plans, including
processes at the plan and post-plan levels for adjudicating appeals.
Medicare rules are found at 42 CFR part 405 subpart I (general) and
part 422 subpart M (Medicare Advantage); Medicaid rules are at 42 CFR
part 431 subpart E (general) and part 438 subpart F (managed care).
Regulations for the Medicare and Medicaid programs take broadly similar
approaches to managed care appeals in that both programs establish a
process for resolving a dispute at the plan level initially, followed
by an opportunity for post-plan review. However, these appeals systems
operate independently with sometimes subtle but important differences
related to notices, adjudication timeframes, availability of benefits
continuing while the appeal is pending, and levels of review.
Similarly, regulations for the Medicare and Medicaid programs take
different approaches with respect to some processes for grievances,
including filing and adjudication timeframes and the availability of an
expedited grievance process.
Although comparatively few beneficiaries file grievances or
appeals,\11\ these processes are vital safeguards to ensure that
beneficiaries' concerns and needs are met promptly. Because of Medicare
and Medicaid's misalignments in this area, beneficiaries who are dually
eligible for Medicare and Medicaid can face a confusing array of
choices when they seek to file a grievance or appeal. They may not know
whether their complaint is tied to Medicare or Medicaid, and thus may
not know where to direct their grievance. They may be uncertain if the
item or service they seek is covered by Medicare, by Medicaid, or
potentially by both programs, and thus may not know when or where to
file an appeal following the denial of a service. The issue is
particularly complicated for items and services such as home health and
certain durable medical equipment that are sometimes covered by both
programs but under different circumstances.
---------------------------------------------------------------------------
\11\ For example, in 2016, Medicare Part C plans reported 2.93
complaints (grievances) per 1,000 enrollees per month and 19.3
reconsideration requests (appeals) per 1,000 enrollees per month.
See Analysis of Calendar Year 2016 Medicare Part C Reporting
Requirements Data, available at https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/PartCDDataValidation.html.
---------------------------------------------------------------------------
This confusion for beneficiaries and for those assisting them can
result in costly and inefficient duplication of effort, as
beneficiaries may file grievances and appeals under both programs when
only one was necessary. Health plans and federal and state agencies may
incur additional burdens and costs from having to administer parallel
appeals systems. Finally, these misalignments may lead to unintended
harms in the form of delayed or denied access to needed services as
beneficiaries expend time and energy pursuing ultimately fruitless
appeals in one program when they should have been pursuing them in the
other.
We have made previous efforts to better align Medicare and Medicaid
grievances and appeals for dual eligible individuals. The success of
these prior efforts suggests to us that further alignment in this area
is feasible. Under Sec. 460.122, the Programs of All-inclusive Care
for the Elderly (PACE) include an integrated appeals system that
handles all initial appeals at the organization level. The Medicaid
managed care May 2016 final rule (81 FR 27478) took several steps to
bring Medicaid managed care grievance and appeals rules into closer
alignment with both Medicare and the private insurance market. Notable
changes for Medicaid managed care enrollees in that final rule included
requiring one single level of plan review prior to the state fair
hearing as well as aligning many timeframes for resolving grievances
and appeals.
The operation of Medicare-Medicaid Plans (MMPs) in the CMS'
Financial Alignment Initiative capitated model demonstrations has
provided us with the most extensive experience integrating grievances
and appeals for dually eligible enrollees in the managed care setting.
MMPs are responsible for covering the full range of Medicare and
Medicaid benefits and operating integrated grievance and appeals
systems. We have developed these systems in collaboration with
participating State Medicaid Agencies, using waiver authority under
section 1115A of the Act and, in some cases, section 1115 of the Act.
Development of these systems has required in-depth examination of
various aspects of Medicare and Medicaid grievance and appeals rules to
determine where misalignments exist and to decide how to resolve these
misalignments in a way that is maximally protective of beneficiaries'
rights. Our experience with MMPs suggests that, although implementing a
new system can be challenging, once in operation integrated grievance
and appeals systems can be simpler for beneficiaries to navigate than
separate systems for Medicare and Medicaid.
Under the newly enacted amendments to section 1859(f)(8)(B) of the
Act, the Secretary is required to establish, not later than April 2020
and for inclusion in contracts for D-SNPs for 2021 and subsequent
years, procedures unifying grievances and appeals procedures consistent
with several principles:
Under paragraph (8)(B)(ii), the new unified procedures
must include provisions that are most protective for the enrollee and,
to the extent feasible as determined by the Secretary, are compatible
with unified timeframes and consolidated access to external review. The
statute requires that the procedures take into account differences
under state Medicaid plans, and be easily navigable by enrollees.
Additionally, under paragraph (8)(B)(iii), the integrated
processes implemented are required to include a single written notice
that includes all relevant grievance and appeal rights; a single
pathway for resolution of covered items and services; notices written
in plain English and available in languages and formats that are
accessible to enrollees (including in non-English languages that are
prevalent in the service area of the specialized MA plan); unified
timelines for processes such as filing, acknowledging, and resolving
the appeal or grievance; and requirements for plans to process, track,
and resolve the grievances and appeals to ensure enrollees are notified
timely of decisions and can track the status of their grievance or
appeal.
Finally, under paragraph (8)(B)(iv), new grievance and
appeals procedures shall, with respect to all benefits under Medicare
Parts A and B and Medicaid subject to appeal under such procedures,
incorporate provisions under current law and implementing regulations
that provide continuation of benefits pending appeal under Title XVIII
and Title XIX. We address this statutory provision in section
II.A.2.b.(7).
Using this statutory framework, we developed the following goals to
guide development of proposals to implement the unified grievance and
appeals provisions:
Adopt provisions that are most protective of the enrollee;
Reduce burden on beneficiaries (and those assisting them),
plans, states, and providers; and
[[Page 55001]]
Maintain state flexibility and minimize disruption by
building on existing rules and policies.
These policy goals also reflect our belief that timely, efficient,
accessible, and well-functioning grievance and appeals systems are
critical to ensuring that beneficiaries have access to needed items and
services. Such systems are especially vital for dually eligible
beneficiaries who typically lack financial resources that might enable
other beneficiaries to pay out-of-pocket for needed items or services
while a dispute is pending. We welcome comments regarding these policy
goals and the extent to which the proposed regulations are consistent
with them.
Our policy goal of minimizing disruption is informed by statutory
language directing the Secretary to establish unified provisions to the
extent feasible (section 1859(f)(8)(B)(i) of the Act). Consistent with
this statutory standard, we are primarily proposing incremental changes
that are currently feasible, conform to other current law, and build
upon existing systems. As we gain further experience with unified
grievances and appeals, we may consider additional changes in the
future, consistent with our authority.
Our proposals under this notice of proposed rulemaking can be
divided into two substantively different types in addition to technical
amendments proposed. We propose to incorporate these changes into and
conform existing regulations in parts 422 and 438. First, we are
proposing to establish requirements for all D-SNPs, relative to the
role they play in assisting full-benefit dual eligible individuals, to
assist with Medicaid-related coverage issues and grievances (Sec.
422.562(a)). Second, we are also proposing new requirements in
accordance with section 1859(f)(8)(B) of the Act to create integrated
grievance and appeals systems for a limited subset of D-SNPs
(``applicable integrated plans''), identified using terms and concepts
we propose to define in amendments to Sec. 422.561, with the
integrated processes established by proposed new regulations
(Sec. Sec. 422.629-422.634). Finally, we propose a number of changes
of a technical and conforming nature to existing provisions in parts
422 and 438 (Sec. Sec. 422.560, 422.562, 422.566, 438.210, 438.400,
and 438.402).
Section 1859(f)(8)(B)(i) of the Act requires the Secretary to
establish unified grievance and appeals procedures for D-SNPs not later
than April 2020, and section 1859(f)(8)(C) of the Act requires the use
of these unified procedures in D-SNP contracts for 2021 and subsequent
years. The statute does not, however, explicitly rule out the
possibility of implementing such unified processes prior to 2021. We
interpret the statute as permitting a state to adopt unified grievance
and appeals processes for integrated D-SNPs and Medicaid plans in that
state consistent with our final regulations on this topic starting as
soon as the regulations establishing such procedures are final. Such a
state could require establishment of unified appeals and grievance
procedures consistent with CMS' regulations in its Medicaid agency
contract required under Sec. 422.107. We solicit comments on this
interpretation of the statutory implementation date requirements and
our proposal to make unified procedures available to states in this way
before 2021.
(1) Assisting With Medicaid Coverage Issues and Grievances (Sec.
422.562(a)(5))
As an incremental step towards improving all D-SNP enrollees'
experiences with accessing Medicaid benefits, and pursuing grievances
and appeals, we propose new regulation text to require all D-SNPs to
assist beneficiaries with Medicaid coverage issues and grievances,
including authorizations for or appeals related to Medicaid-related
services at Sec. 422.562 by adding a new paragraph (a)(5). These new
requirements are consistent with our existing guidance and expectations
for D-SNPs, but we are proposing regulations to define their scope and
set mandatory standards to which we can hold D-SNPs accountable.
Consistent with the statutory requirement at section 1859(f)(3)(D) of
the Act that D-SNPs arrange for their enrollee's Medicaid benefits, we
believe that all D-SNPs should assist enrollees with resolving Medicaid
coverage problems, including assistance with filing grievances,
requesting coverage, and requesting appeals. Such assistance is
consistent with the standard we are proposing as part of the definition
of a D-SNP in section II.A.2.a of this proposed rule, which states that
all D-SNPs provide a minimum level of coordination across Medicare and
Medicaid. Under our proposal, D-SNPs have a responsibility to
coordinate the delivery of Medicaid services for enrollees whether or
not the D-SNP itself contracts with the state to provide Medicaid
services. We clarify here that the requirements at 422.562(a)(5) are
additional requirements for D-SNPs, specifically related to assisting
with access to benefits, appeals and grievances. At Sec.
422.562(a)(5), we propose to supplement the obligation to provide, as
applicable, and coordinate Medicaid benefits by adding a requirement
that when a D-SNP receives an enrollee's request for services, appeal,
or grievance related to Medicaid-covered services (regardless of
whether such coverage is in Medicaid fee-for-service or a Medicaid
managed care plan, such as a Medicaid MCO, PIHP, or PAHP as defined in
Sec. 438.2), the D-SNP must provide a certain level of assistance to
the enrollee. This proposal, which we hope would result in a more
seamless process for enrollees in accessing Medicaid benefits and
pursuing grievance and appeals for D-SNP enrollees, complements how we
believe section 1859(8)(f)(B) of the Act directs us to unify D-SNP and
Medicaid appeal and grievance procedures to the extent feasible.
In new paragraph (a)(5)(i), we propose to describe the types of
assistance we would require all D-SNPs to provide to their enrollees
regarding Medicaid-related coverage issues and grievances, including
authorization of services, and appeals. We propose in paragraph
(a)(5)(i) to include assistance for all D-SNP enrollees, regardless of
the type of Medicaid coverage in which they are enrolled. While we
specifically list Medicaid fee-for-service and Medicaid managed care
plans, it is not our intention to exclude any type of Medicaid delivery
system. However, we request comment on whether there are other systems
that should be noted specifically, or if there are specific
circumstances where providing the assistance contemplated in this
section is ill-advised or infeasible.
Our proposed regulation at Sec. 422.562(a)(5)(i) includes a list
of illustrative examples, at paragraphs (5)(i)(A) through (5)(i)(C),
which we do not intend to be an exhaustive list of how a D-SNP would be
required to comply with the assistance obligation in Sec.
422.562(a)(5)(i). In paragraph (a)(5)(i)(A), we address explaining to a
D-SNP enrollee how to request Medicaid authorization and file an
appeal. Our proposed text includes examples of the type of assistance
we expect D-SNPs to provide to their enrollees when the enrollees need
information and explanations about obtaining Medicaid services. We
recognize that state Medicaid systems vary substantially, and that the
specific forms of assistance will also vary from market to market. We
do not seek to be overly prescriptive in the types of assistance a D-
SNP must provide, and our examples are not intended to be exhaustive.
We propose, in paragraphs (5)(i)(A)(1) through (5)(i)(A)(3), examples
of the types of assistance that
[[Page 55002]]
a D-SNP must offer, and upon acceptance or request, provide its
enrollees, such as specific instructions on how to contact the entity
that may cover the service (for example, the Medicaid managed care plan
or a contact in the fee-for-service system), and assistance in
obtaining and filling out forms necessary for the next steps in the
process.
In paragraph (a)(5)(i)(B), we propose that D-SNPs provide
assistance in the actual filing of grievances and appeals. Not all
enrollees would need such assistance; for many enrollees, simply
receiving information under paragraph (a)(5)(i) would be sufficient.
When a D-SNP enrollee needs assistance with the act of filing a
Medicaid grievance or appeal, their D-SNP should provide that help.
However, the D-SNP is not obligated to represent the enrollee in
Medicaid appeals. We welcome comments regarding this proposal; in
particular, we ask for comments regarding how D-SNPs that do not have
aligned enrollment would comply with this requirement when such
entities might have financial and clinical responsibility for the
disputed services, potentially presenting a conflict of interest.
In paragraph (a)(5)(i)(C),we propose that the D-SNP assist the
enrollee in obtaining documentation in support of a request for
authorization or appeal. Obtaining documents such as medical records
can be a challenge for any beneficiary, especially for those with
limited resources who may lack broadband access to receive large
documents electronically, may have unreliable mail service, may not be
able to afford printing costs, and may not have easy access to
transportation to pick up documents in person. We believe that D-SNP
care coordinators are a logical choice to help an enrollee assemble
medical documentation and may be particularly well-positioned to assist
in compiling records, as they would have insight into the types of
documentation enrollees need to support similar requests made to the D-
SNP.
The examples listed in proposed paragraph (a)(5)(i)(A) through (C)
are not intended to be an exhaustive list, but rather are to provide
some leading examples of the assistance we believe any D-SNP should
provide. Accordingly, it would not be acceptable for a D-SNP to tell an
enrollee simply to contact ``Medicaid'' in general when the enrollee
encounters a problem with his or her Medicaid coverage or is obviously
in need of assistance in figuring out how to file an appeal of a denial
of Medicaid-covered benefits. We invite comments on this proposal,
specifically whether the regulation text is clear enough that the
examples are not an exhaustive list of methods of assistance that the
D-SNP must offer its enrollees, as well as suggestions for other
examples of assistance that we should include in regulation or address
in subsequent subregulatory guidance.
In proposing these amendments to Sec. 422.562(a)(5), we recognize
that offering and providing useful, effective assistance--and therefore
compliance with this proposed requirement--may appear challenging. For
example, some D-SNPs today may have difficulty determining what type of
Medicaid coverage a member has (for example, fee-for-service vs.
managed care; which specific managed care plan the enrollees is in;
which services are carved out). Without accurate and timely information
on the enrollee's Medicaid coverage, it is difficult to effectively
help the enrollee navigate, for example, which entity to contact, and
what forms are necessary, to pursue coverage or an appeal. Full
compliance with our proposal requires that D-SNPs and states maintain
data sharing that allows D-SNPs to determine the type and source of
Medicaid coverage of their enrollees. However, we believe it is
reasonable to expect that D-SNPs, as plans focused on serving dually
eligible beneficiaries, take steps to access such information to
provide effective care coordination for dual eligible enrollees and to
implement more seamless (even if not unified) grievance and appeals
systems. Moreover, providing such assistance may further be in a D-
SNP's interest, if the enrollee's access to Medicaid-covered services
like personal care services and other HCBS prevents an otherwise
avoidable hospitalization, for example. We welcome comments on this
proposal, suggestions for additional examples of assistance, as well as
comments on challenges D-SNPs and others envision in implementing the
provisions of proposed paragraph (a)(5).
We also propose language related to enrollees accepting the offer
of assistance in proposed paragraph (a)(5)(i). We do not expect or want
D-SNPs to implement any processes that might act as barriers to
enrollees in accessing assistance nor do we want to create barriers to
D-SNPs providing such assistance; if an enrollee does not want the D-
SNP's help in resolving an issue, then the D-SNP would not be obligated
under our proposal to provide assistance against the enrollee's wishes.
At the same time, we do not intend to create any affirmative obligation
on the D-SNP to assist enrollees if they decline the offer of
assistance. Enrollees are free to decide for themselves how to navigate
their Medicaid coverage. In our proposal, the only obligation on D-SNPs
is to offer assistance, and when a request is made or an offer of
assistance is accepted, to provide it. We welcome comments on whether
the regulation text, as we have proposed it, is the best way to achieve
this goal.
In paragraph (a)(5)(ii), we propose to specify that the D-SNP's
obligation to offer assistance arises whenever the D-SNP becomes aware
of an enrollee's need for a Medicaid-covered service. Our proposal
includes text explicitly clarifying that enrollees do not need to make
a specific request to their D-SNP for assistance. We expect that D-
SNPs, as plans with expertise in serving dually eligible beneficiaries,
should be able to identify a potential Medicaid coverage issue as part
of their regular assessments and care management processes. For
example, a D-SNP may become aware that an enrollee is unsatisfied with
the personal care services she is receiving based on the work of a care
coordinator or from a call or email from the enrollee or enrollee's
family. Our proposed regulation text does not explicitly require a D-
SNP to use its care coordination or case management programs to
identify this type of issue. However, if the issue comes to the
attention of the D-SNP, we would expect the plan to offer to assist the
enrollee in resolving the coverage issue(s) or grievance given the D-
SNP's responsibility, consistent with our proposed definition of a D-
SNP at Sec. 422.2, that such a D-SNP provide, as applicable, and
coordinate the delivery of Medicare and Medicaid services for its
enrollees. We request comments on whether we should include such
explicit direction to D-SNPs in the regulation to identify issues that
an enrollee is having, or whether our proposed regulation text is
sufficiently clear that D-SNPs will understand and meet our goal of
providing assistance to an enrollee such that the enrollee can access
benefits regardless of whether the benefit is covered by Medicare or
Medicaid. We are not proposing any new requirements related to
assistance with Medicare covered services. We are also not proposing
any new requirements related to services for partial-benefit dual
eligible enrollees. Partial-benefit dual eligible enrollees do not
qualify for the full range of Medicaid services, and therefore, we do
not believe the proposed rule creates any new obligation for D-SNPs to
offer assistance for such enrollees. We welcome comments regarding the
provisions at proposed
[[Page 55003]]
Sec. 422.562(a)(5)(ii) and the need for any further clarification
limiting the scope of Sec. 422.562(a)(5) to full-benefit dual eligible
individuals.
In paragraph (a)(5)(iii), we propose to provide further detail on
the methods of assistance required by proposed paragraph (a)(5)(i). The
methods we propose in the regulation are intended to be examples of
what a D-SNP will be required to offer and provide to enrollees and
will depend, to some extent, on the needs and preferences of the
enrollee. In paragraph (a)(5)(iii)(A), we note that a D-SNP may provide
coaching to the enrollee to promote self-advocacy. Some dually eligible
enrollees are highly adept at advocating for themselves, and may
require only modest assistance--for example, a phone number or
direction to an appropriate website--or help with technical terms in
explaining why they need a specific piece of equipment. We welcome
comments on the methods of assistance and whether further detail is
needed. In paragraph (a)(5)(iii)(B) we propose to make explicit a
requirement that a D-SNP provide whatever reasonable assistance an
enrollee needs in navigating the Medicaid grievance and appeals
systems, such as assistance completing forms. We note that existing
regulations (for example, Sec. Sec. 422.111(h)(1)(iii) and 438.406(a))
address the provision of interpretation services. In the context of
grievances and appeals, Medicaid requirements also currently require
auxiliary aids and services for enrollees who have limited English
proficiency or disabilities that require accommodation (Sec.
438.406(a)).\12\ The language in this section is very similar to
obligations already required of Medicaid managed care organizations at
Sec. 438.406(a). Medicare plans also have existing obligations under
Title VI of the Civil Rights Act of 1964 to take reasonable steps to
ensure meaningful access by individuals with limited English
proficiency and under section 504 of the Rehabilitation Act to take
appropriate steps to ensure effective communication with individuals
with disabilities, including the provision of auxiliary aids and
services. We have opted not to specify the preferred technical forms of
assistance that would be required under this proposal, as the evolution
of technology and the increases in integration over time may change the
analysis of what methods of assistance are reasonable for a D-SNP to be
required to provide to its enrollees. However, because D-SNPs are
already required to provide similar assistance to their enrollees in
other circumstances, we do not anticipate that compliance with this
provision should be burdensome to plans. We welcome comments on this
matter, including whether and how our goals might be met with more
specific regulation text.
---------------------------------------------------------------------------
\12\ In addition, the Medicaid managed care regulation at Sec.
438.10(d) addresses the requirement to provide translation and
assistance in a broader context.
---------------------------------------------------------------------------
In paragraph (a)(5)(iv), we propose to require that a D-SNP provide
documentation to CMS upon request that demonstrates how the D-SNP is
providing the assistance proposed under paragraph (a)(5)(i).
In paragraph (a)(5)(v), we propose to clarify that D-SNPs are not
required to represent enrollees in Medicaid appeals. We welcome
comments regarding whether any further clarification is needed on this
issue.
(2) Statutory Basis and Scope for Unifying Grievances and Appeals
(Sec. 422.560)
In Sec. 422.560, we propose to add new paragraphs (a)(4) and
(b)(5) to address the statutory basis and scope of our proposal to
establish unified grievance and appeals processes for a subset of D-
SNPs. Specifically, we are proposing a new paragraph (a)(4) to cite
section 1859(f)(8) of the Act and provide that the procedures under
that section apply in place of otherwise applicable grievance and
appeals procedures with respect to items and services provided by
certain D-SNPs. We are also proposing to add new paragraph (b)(5) to
identify the scope of the new proposed regulations--that is,
requirements for applicable integrated plans with regard to unified
appeals and grievance procedures. The substance of these proposals is
addressed in sections II.A.2.a.(3) through (11) of this proposed rule.
(3) Definitions of ``Applicable Integrated Plan'', ``Integrated
Appeal'', ``Integrated Grievance'', ``Integrated Organization
Determination'', and ``Integrated Reconsideration,'' and General
Requirements for Applicable Integrated Plans (Sec. Sec. 422.561 and
422.629)
A central challenge to implementing unified grievance and appeals
systems for D-SNPs and the Medicaid managed care organization operated
by such plan's parent organization is the variety of enrollment
scenarios across states. There are only a limited number of D-SNPs in
which aligned enrollment, as defined in proposed Sec. 422.2, is
possible--that is, a situation when a full-benefit dual eligible
individual is enrolled in a D-SNP and receives coverage of Medicaid
benefits from the D-SNP or from a Medicaid managed care organization,
as defined in section 1903(m) of the Act, operated by the D-SNP's
parent organization or by another entity that is owned and controlled
by the D-SNP's parent organization. Even fewer D-SNPs operate in states
where that State Medicaid Agency mandates such aligned enrollment. With
exclusively aligned enrollment, all of the enrollees of the D-SNP also
receive Medicaid services through the D-SNP or an affiliated Medicaid
managed care organization operated by such plan's parent organization.
We believe it is most feasible to unify grievance and appeals systems
under exclusively aligned enrollment because one organization is
responsible for both Medicare and Medicaid coverage, albeit through
separate contracts.
The bulk of D-SNP enrollment, however, is not exclusively aligned.
In most states, the majority of D-SNP enrollees have Medicaid coverage
either through a different organization's Medicaid MCO, in a prepaid
ambulatory or inpatient health plan (PAHP or PIHP), or through a
state's Medicaid fee-for-service system. In these circumstances, the D-
SNP has no control over the Medicaid grievance and appeals processes.
Even a D-SNP that has a Medicaid managed care organization operated by
such plan's parent organization available to its enrollees, but whose
members may instead enroll in other Medicaid plans, can only unify the
procedures for Medicaid appeals and grievances of those enrollees who
are also simultaneously enrolled in the Medicaid managed care
organization operated by such plan's parent organization. We do not
believe it is feasible at this time to implement fully unified
grievance and appeals systems for D-SNPs and Medicaid managed care
plans that do not have the same enrollees or where the organizations
offering the D-SNPs and Medicaid plans are unaffiliated or even
competitors.
We propose to add definitions for new terms used in this notice of
proposed rulemaking to govern the integrated grievance and appeals
processes. In Sec. 422.561 we propose new definitions for ``applicable
integrated plan,'' which is the specific type of D-SNP and affiliated
Medicaid plan that would be governed by the new integrated grievance
and appeals regulations. In our definition of applicable integrated
plan, we propose to include only a subset of D-SNPs, that is, only FIDE
SNPs and HIDE SNPs with exclusively aligned enrollment, terms that are
defined at proposed Sec. 422.2 and described in section II.A.2.a.(1)
of this proposed rule. We propose that the
[[Page 55004]]
affiliated Medicaid plan be a Medicaid managed care organization, as
defined in section 1903(m) of the Act, that is offered by--(1) the D-
SNP with exclusively aligned enrollment; (2) the parent organization of
such D-SNP; or (3) another entity that is owned and controlled by the
parent organization of such D-SNP. Thus, our proposal for unified
grievance and appeals procedures would apply only to the enrollees of
the subset of D-SNPs that are FIDE SNPs or HIDE SNPs with exclusively
aligned enrollment and the affiliated Medicaid managed care
organizations through which such enrollees receive their Medicaid
services. As we note in our discussion of the proposed definition of
aligned enrollment in section II.A.2.a of this proposed rule, we would
not consider a D-SNP's companion Medicaid plan to be an applicable
integrated plan where it is a prepaid inpatient health plan (PIHP) or
prepaid ambulatory health plan (PAHP) in the state's Medicaid program.
We solicit comments on our proposed definition of an applicable
integrated plan and how it reflects which plans and entities would have
to use the unified grievance and appeals procedures we propose in this
rule. We also seek comment on whether limiting our proposed policies to
MCOs, rather than including PIHPs and PAHPs, is appropriate in light of
the statute and our policy goals.
The requirements for non-fully integrated D-SNPs would remain
unchanged. This means that there would be different sets of
requirements for different types of D-SNPs, and we are proposing these
new defined terms to make these separate requirements distinct. We
estimate that, currently, this subset of plans comprises a small share
of the overall D-SNP market: 37 plans in 8 states, covering
approximately 150,000 enrollees nationwide. We believe that these are
the plans for which integrated grievance and appeals processes as we
propose here are most suitable. We seek comment on our belief that
exclusively aligned enrollment provides the most feasible context for
unifying grievance and appeals systems and--recognizing that states can
organize managed care enrollment policy in a variety of ways--whether
our use of the term ``exclusively aligned enrollment'' captures the
optimal universe of managed care arrangements for such unification.
For the purpose of differentiating the terminology and procedures
within this framework, we propose to establish definitions for
``integrated organization determination,'' ``integrated appeal,''
``integrated reconsideration,'' and ``integrated grievance'' and apply
them exclusively to applicable integrated plans.
Integrated organization determinations would encompass both
Medicare organization determinations, as described in Sec. 422.566,
and adverse benefit determinations, as defined in Sec. 438.400(b);
however, these determinations would be made by applicable integrated
plans and would therefore be subject to the integrated organization
determination procedures in proposed Sec. Sec. 422.629, 422.631, and
422.634. These would be the first decisions made by the applicable
integrated plan regarding coverage, approval, or payment for a covered
service. We propose to define this term by referencing Medicare
organization determinations as described in Sec. 422.566, actions as
defined in Sec. 431.200, and adverse benefit determinations as defined
in Sec. 438.400(b) to parallel the scope of the MA, Medicaid, and
Medicaid managed care regulations, rather than by using a specific list
of decisions or actions to ensure that the applicable regulations using
this term truly unify and integrate the applicable concepts from both
the Medicare and Medicaid programs.
Similarly, integrated reconsiderations would be the appeal of the
adverse integrated organization determinations by an applicable
integrated plan with respect to the health care services the enrollee
believes he or she is entitled to receive, including delay in
providing, arranging for, or approving the health care services (such
that a delay would adversely affect the health of the enrollee), or on
any amounts the enrollee must pay for a service. Under our proposal, an
integrated reconsideration would be the same as an MA plan's
reconsideration (in Sec. 422.580) of an organization determination
(defined in Sec. 422.566) and the appeal (defined in Sec. 438.400(b))
of an adverse benefit determination. Integrated reconsiderations would
encompass both Medicare reconsiderations, as described in Sec. Sec.
422.578, 422.580, 422.582, and 422.584, and appeals, as defined for the
Medicaid managed care context in Sec. 438.400(b). However, these
determinations would be made by applicable integrated plans and
therefore subject to the integrated reconsideration procedures in
proposed Sec. 422.629 and 422.632 through 422.634.
We propose defining integrated appeals to encompass integrated
reconsiderations, and any additional post-plan level unified appeal
processes that may be implemented in the future. Our proposed
definition is similar to the definition of appeal in MA, at Sec.
422.561, which encompasses both the reconsideration level of the appeal
process, as well as additional stages of the appeals process such as
review by an independent entity, hearings before ALJs, review by the
Medicare Appeals Council and judicial review.
Additionally, we propose to define an integrated grievance as a
dispute or complaint that would be defined and covered, for grievances
filed by an enrollee in non-applicable integrated plans, under Sec.
422.564 or Sec. Sec. 438.400 through 438.416. Integrated grievances
would not include appeals procedures or QIO complaints, as described in
Sec. 422.564(b) and (c), respectively. An integrated grievance made by
an enrollee in an applicable integrated plan would be subject to the
integrated grievance procedures in Sec. Sec. 422.629 and 422.630. This
means that an integrated grievance would include a Medicare or Medicaid
complaint or dispute about the applicable integrated plan or the
enrollee's providers that is not a complaint or dispute about such
plan's coverage determination (referred to as an integrated
organization determination in this proposed rule).
Our proposed definitions for integrated grievance, integrated
organization determination, and integrated reconsideration are intended
to replicate the scope and meaning of the parallel terms in parts 422
subpart M and part 438 subpart E regarding the appeals and grievance
procedures required of, respectively, MA organizations and Medicaid
managed care plans because we are proposing that the regulations and
procedures proposed here take the place of those part 422 and part 438
procedures for applicable integrated plans. We solicit comment whether
our proposal adequately accomplishes this.
We propose at Sec. 422.629 to establish general requirements for
applicable integrated plans, as defined in Sec. 422.561. In paragraphs
(a) and (b), we propose language that sets forth the scope of the
requirements and general process that applicable integrated plans must
implement. In paragraph (a)(1), we propose to specify that the proposed
rules apply in lieu of the general requirements for MA organizations at
Sec. Sec. 422.564, 422.566(c) and (d) and 422.568-422.596, and
Medicaid managed care plans at Sec. Sec. 438.404-438.424, and
encompass integrated grievances, integrated organization
determinations, and integrated reconsiderations. In paragraph (b), we
set forth the general requirement that applicable integrated plans
create
[[Page 55005]]
integrated processes to administer these grievance and appeals
requirements.
In proposed paragraph (c), we address an overarching question about
whether a state may establish requirements that are different for the
applicable integrated plan(s) using the state Medicaid agency contract
required under Sec. 422.107. Specifically, we propose to apply the
flexibility offered to states under Medicaid regulations, which
establish a floor for enrollee protections, while also offering states
flexibility to impose more stringent requirements for timeframes and
notices so long as they are more protective of beneficiaries. States
may already have laws in effect that take advantage of this
flexibility. For example, under Sec. 438.408(b)(2), a Medicaid managed
care plan must resolve a standard appeal within a timeframe established
by the state, but not to exceed 30 calendar days. The maximum timeframe
for an MA organization to decide a standard reconsideration is also no
later than 30 calendar days (Sec. 422.590(a)(1)). Ohio Medicaid,
however, sets this timeframe for its Medicaid managed care plans at 15
days unless an extension is granted.\13\ If an integrated appeals
process under this proposal were to be implemented in Ohio, we would
allow adoption of that 15-day standard for all standard integrated
appeals. We believe that by preserving state flexibility in adopting
more stringent, beneficiary-protective requirements, we are adhering to
the direction set forth in sections 1859(f)(8)(B)(ii)(I) and (II) of
the Act for us to take into account differences in state plans under
Title XIX. Finally, in paragraph (c), we propose to codify the
opportunity for states to establish standards that differ from the
standards set forth in these regulations in its State Medicaid Agency
contract, per Sec. 422.107, with the applicable integrated plans. We
are soliciting comments on our proposed approach, and specifically how
we propose to allow state flexibilities to be incorporated into the
unified procedures for an applicable integrated plan.
---------------------------------------------------------------------------
\13\ See Ohio Administrative Code 5160-58-08.4(D)(6), available
at http://codes.ohio.gov/oac/5160-58-08.4.
---------------------------------------------------------------------------
In paragraph (d), we propose that the applicable integrated plan
provide the enrollee who is requesting the integrated reconsideration a
reasonable opportunity, in writing and in person, to present evidence
and testimony and make legal and factual arguments in support of their
appeal. On this topic, both the MA standard at Sec. 422.586 and the
Medicaid standard at Sec. 438.406(b)(4) are similar in granting this
right to the enrollee for the plan-level appeal; however, under
Medicaid regulation, this right extends to grievances, whereas in MA,
it does not. We also propose to require that applicable integrated
plans inform enrollees of the limited time available for these
opportunities in cases were the timeframe is expedited, similar to
Sec. 422.586 and Sec. 438.406(b)(4).
In paragraph (e), we propose to require applicable integrated plans
to provide reasonable assistance to the enrollee with respect
completing and submitting their integrated appeals and integrated
grievances, as well as on navigating this process. This proposal would
impose on applicable integrated plans a similar standard as applies to
Medicaid managed care plans pursuant to Sec. 438.406(a). As discussed
earlier, plans have existing obligations under Title VI of the Civil
Rights Act of 1964 and section 504 of the Rehabilitation Act, so we do
not believe that incorporating this beneficiary protection to this
context would create an unreasonable burden. Here, as also discussed
earlier in this preamble related to proposed Sec. 422.562(b)(3)(ii),
we opted not to specify the preferred technical forms of assistance, as
preferred standards can change as technology evolves.
We propose at paragraph (f) a general rule, using cross-references
to the requirements in Sec. Sec. 422.560, 422.561, 422.562, 422.566,
and 422.592 through 422.626, to specify the regulations that apply to
the applicable integrated plan for grievance and appeals processes
unless otherwise noted.
We propose at paragraph (g) to require applicable integrated plans
to send the enrollee an acknowledgement of receipt in writing for all
integrated grievances and integrated reconsiderations. Currently, the
Medicaid regulation at Sec. 438.406(b) requires acknowledgement of
grievances and appeals, and MA guidance explains the need for written
acknowledgement of oral requests for reconsideration (see Medicare
Managed Care Manual Chapter 13, section 70.2). Section
1859(f)(8)(B)(iii)(IV) of the Act, as added by section 50311(b) of the
Bipartisan Budget Act of 2018, specifically calls for unified timelines
and procedures for acknowledgement of appeals and grievances We propose
to adopt the standard currently in Sec. 438.406(b) for applicable
integrated plans, and we propose to clarify that the acknowledgement
should be in written form. We believe that this requirement is both
beneficial to enrollees and assists them in determining the status of
the grievance or appeal, and thus is in alignment with the standard in
section 1859(f)(8)(B) of the Act for the unified procedures.
In paragraph (h), we propose to adopt Medicaid's grievance and
appeals recordkeeping requirements, as required for Medicaid managed
care plans at Sec. 438.416, to require applicable integrated plans to
maintain records of integrated appeals and grievances and review them
as part of their ongoing monitoring procedures. The requirements that
we propose also align with relevant MA requirements for grievance
recordkeeping (see Sec. 422.564(g)) and are consistent with the MA
requirements for general recordkeeping (see Sec. 422.504(d)).
We propose in paragraphs (i) and (j) to incorporate similar
provisions as are imposed on Medicaid managed care plans pursuant to
Sec. Sec. 438.410(b) and 438.414 regarding relationships between the
plan and its contracted network providers. Specifically, in paragraph
(i), we propose to prohibit an applicable integrated plan from taking
any punitive action against a provider for requesting an integrated
organization determination or integrated reconsideration, similar to
the provisions in Sec. Sec. 422.570(f) and 438.410(b). We believe that
these standards would establish beneficiary protections in the context
of applicable integrated plans because the threat of punitive action
might otherwise discourage a provider from pursuing, on the enrollee's
behalf, or supporting an enrollee in pursuing, an integrated appeal for
a needed item or service. We also propose requiring, in paragraph (j),
such a plan to disclose information about its appeals and grievances
procedures at the time it enters into a contract with a provider or
subcontractor. We propose to include specific topics which must be
covered in this information to providers, and these specific topics are
the same as in existing Medicaid regulations (see Sec. 438.414, which
cites to Sec. 438.10(g)(2)(xi) for this purpose). Although there are
no specific MA regulations that impose the same requirements on D-SNPs,
Medicare regulations require that MA organizations communicate
information on medical policy and medical management procedures (see
Sec. 422.202(b)). We believe this proposed requirement aligns with the
goals of the statute in educating providers to help ensure an easily
navigable system for enrollees, where providers understand the system
and their role in it.
In paragraph (k), we propose regulatory standards controlling who
must review an integrated organization determination. The part 422 and
part
[[Page 55006]]
438 regulations each impose standards of this type but they are not
identical. In developing our proposal, we sought to combine the MA and
Medicaid managed care requirements for who must review an organization
determination. This new requirement would apply to grievances, as is
currently the case Sec. 438.406 but not in the applicable MA
regulations. In paragraph (k)(1), we propose to include the requirement
from Medicaid (Sec. 438.406(2)(iii)) that any individual who reviews
an integrated appeal or grievance must consider all information
submitted by the enrollee, regardless of whether the information was
previously made available to the plan. In paragraph (k)(2), we propose
to include the requirements for reviews of Medicaid grievances (from
Sec. 438.406(2)) for who can review a grievance to integrated
grievances. There are no requirements in Medicare for who can review a
grievance; however, we believe that ensuring that the individual who
reviews a grievance has appropriate expertise for the circumstances is
an important enrollee protection that should be applied to integrated
grievances.
In paragraph (k)(3), we propose to include the existing
requirements from MA (Sec. 422.566) for who can review an organization
determination. There are no requirements in Medicaid for who can review
a service authorization request; however, we believe that ensuring that
the individual who reviews an integrated organization determination has
appropriate expertise for the circumstances is an important enrollee
protection that should be applied to integrated organization
determination. We also propose language that, in accordance with
current MA regulations (Sec. 422.566(d)) requires that physicians or
other health care professionals who review integrated organization
determinations have an unrestricted license and be acting within the
scope of that license.
In paragraph (k)(4) we propose to combine existing MA and Medicaid
requirements for who can review a reconsideration or adverse benefit
determination since both sets of existing regulations have relevant
requirements. MA and Medicaid requirements are largely similar for
individuals who review appeals be someone who was not involved in a
previous level of review, and, in cases involving medical necessity,
someone who has appropriate clinical expertise (Sec. Sec. 422.590 and
438.406(b)(2)). These existing requirements are reflected in our
proposed requirements.
(4) Authorization for Filing Appeals (Sec. 422.629(l))
We propose at Sec. 422.629(l) to combine the MA and Medicaid
requirements, such that a treating provider or authorized
representative can file an appeal on behalf of an enrollee. Medicaid
managed care rules at Sec. 438.402(c)(1)(ii) require written
authorization from the enrollee where a physician or other authorized
representative files an appeal involving a benefit to which the
enrollee may be entitled. MA rules at Sec. 422.566(c), however, allow
a treating provider to file an appeal on behalf of an enrollee without
written authorization from the enrollee, although the provider is
required to provide notice to the beneficiary. We believe the MA
requirement is generally more beneficial to beneficiaries, as it
imposes fewer procedural requirements to filing an appeal for the
enrollee, for example, if an enrollee has factors that make signing an
authorization difficult. The Medicaid requirements, on the other hand,
may serve to mitigate the risk that a provider would file an appeal
against an enrollee's interest and without an enrollee's consent,
particularly to take advantage of the Medicaid provisions that allow a
benefit to continue while the appeal is pending, an issue we discuss in
more detail in section II.A.1.b.(7) of this preamble for proposed Sec.
422.632. We believe our proposal reduces barriers for enrollees to have
appeals filed, while also accounting for risk to enrollees by requiring
the enrollee's written consent only when there is a request for
continuation of benefits. However, we invite comments as to whether an
approach closer to Medicaid's, in which written authorization would be
required in all cases when a provider files an appeal on behalf of a
beneficiary, would be preferable.
(5) Integrated Grievances (Sec. 422.630)
At Sec. 422.630, we propose to largely parallel Medicare and
Medicaid requirements where these requirements are the same with regard
to the treatment of integrated grievances. Where MA includes a
requirement that Medicaid does not, or vice versa, or where the MA and
Medicaid regulations conflict, we propose applying the requirement that
best aligns with the principles and statutory requirements discussed in
section II.A.1.b. of this preamble. For integrated grievances, we
specifically propose:
At paragraph (a), to establish the general purpose of the
regulation, similar to Sec. 438.402(a) and Sec. 422.564(a), by
requiring that an applicable integrated plan provide meaningful
procedures for timely hearing and resolving integrated grievances filed
by an enrollee. We propose to define the scope of the required
procedures as being applicable to any grievances between the enrollee
and the plan or any entity or individual through which the applicable
integrated plan covers health care services. We propose this
requirement for the applicable integrated plan to be responsible for
ensuring timely and appropriate resolution of a grievance even if the
grievance pertains to an act or decision by one of the applicable
integrated plan's contracted providers or vendors. Our proposed
regulation text mirrors the Medicare Advantage language at Sec.
422.564(a) for this requirement. We believe that clearly ensuring that
an applicable integrated plan is ultimately responsible for resolving
all grievances related to services that it is responsible for providing
is an important enrollee protection and provides enrollees with an
easily navigable, single pathway for resolution of grievances,
consistent with sections 1859(f)(8)(B)(ii)(I) and (III) and (iii)(II)
of the Act.
At paragraph (b), to provide that an enrollee may file a
grievance at any time. The relevant Medicaid regulation (Sec.
438.402(c)(2)(i)) allows a grievance to be filed at any time, while the
MA regulation (Sec. 422.564(d)(a)) limits grievance filing to within
60 days of the event at issue. We propose to impose the standard that
is more protective of enrollees on applicable integrated plans.
At paragraph (c), to allow grievances orally or in
writing, in alignment with Medicare and Medicaid requirements, while
allowing for integrated grievances related to Medicaid benefits to be
filed with the state, in states that have processes in place in
accordance with Sec. 438.402(c)(3). We propose to include current
state processes, where they exist, for enrollees to file grievances
with the state that relate to Medicaid benefits. The option for a state
to accept grievances currently exists in the Medicaid regulations (see
Sec. 438.402(c)(3)). We believe that this is an important protection
for enrollees and, in proposing requirements that are most protective
to the enrollee and take into account differences in state plans, we
are proposing to leave this option for filing grievances open to
enrollees, if it is otherwise an option in the state's Medicaid
program.
At paragraph (d), we propose to largely parallel the
Medicare Advantage requirements (at Sec. 422.564(f)) for when an
enrollee can file an expedited
[[Page 55007]]
grievance because we find them a protection for beneficiaries. Medicare
Advantage regulations require that plans provide for expedited
grievances in cases when: (1) A plan extends the timeframe for
resolving an organization determination or reconsideration, or (2) the
grievance involves a refusal to grant an enrollee's request for an
expedited organization determination or reconsideration (Sec.
422.564(f)). The Medicaid managed care regulations do not include a
federal provision for expedited grievances.
At paragraph (e)(1), to parallel Medicare Advantage's 30-
day timeframe for resolving the grievance and Medicare Advantage's
requirements for how the applicable integrated plan must respond to
grievances, depending on how the grievance is received and the basis
upon which the enrollee filed the grievance; again we find the Medicare
Advantage provision to be more protective of enrollees. Medicaid
requires plans to resolve grievances within 90 days (Sec.
438.408(b)(1)), while Medicare Advantage regulations require that plans
resolve them within 30 days (Sec. 422.564(e)). Medicare Advantage
regulations address the issue of how a managed care plan must respond
to grievances depending on how the grievance was received and the issue
in dispute (Sec. 422.564(e)(3)). Medicaid leaves requirements for
responding to grievances to the state to determine, provided that the
requirements set by the state meet, at a minimum, the requirements
described at Sec. 438.10 (Sec. 438.408(d)(1)).
At paragraph (e)(2), to include a provision permitting the
applicable integrated plan to extend the time period in which a
determination on an integrated grievance must be issued to the
enrollee. We propose this provision to parallel Medicare Advantage
(Sec. 422.564(e)(2)) and Medicaid managed care (Sec. 438.408(c)(1))
requirements that extend the grievance resolution timeframe by up to 14
days. We also propose to adopt a combination of the Medicare Advantage
and Medicaid managed care requirements for how an applicable integrated
plan must notify an enrollee of an extension. MA regulations require
that the MA plan immediately notify the enrollee in writing of the
reason for the delay (Sec. 422.564(e)(2)), while Medicaid managed care
requires notice within 2 calendar days (Sec. 438.408(c)(2)). We have
combined those requirements in our proposal here, such that applicable
integrated plans must notify enrollees immediately, but no later than
within 2 calendar days, which we believe to be in line with the
principles identified in section 1859(f)(8)(B)(iii) of the Act for
timely, clear notification for enrollees.
We invite comments on these topics, specifically whether the
proposed regulation text accurately incorporates the standards from the
underlying part 422 or part 438 regulation that are more beneficial to
the enrollee.
For each of these issues, we propose to adopt the requirement that
is most protective for enrollees and that ensures timely, clear, and
understandable resolution and notification. We propose to give
enrollees the most flexibility in filing a grievance by not putting any
limits on when it can be filed and providing clear guidance to ensure
enrollees can support their cases with relevant information. We also
propose timeframes that ensure plans resolve the grievance quickly and
provide clear notice to enrollees of the resolution. We solicit comment
on whether we have adequately captured all relevant enrollee
protections here.
(6) Integrated Organization Determinations (Sec. 422.631)
In proposed Sec. 422.631, we describe the procedures applicable
integrated plans would follow in making an integrated organization
determinations. In paragraph (a), we propose that, as part of a unified
process, all requests for benefits covered by applicable integrated
plans must be subject to the same integrated organization determination
process.
In paragraph (b), we propose to adopt the MA provisions at Sec.
422.568(a) allowing an enrollee to request an integrated organization
determination either orally in writing, but requiring requests for
payment to be made in writing. The Medicaid managed care regulations do
not include specific rules in this area.
In paragraph (c), we propose to articulate the standard for making
an expedited organization determination. Both MA (at Sec. 422.570(c))
and Medicaid (at Sec. 438.210(d)(2)) have similar standards for an
expedited organization determination, and we propose to reflect the
standards of both programs. This proposed provision tracks existing MA
regulation language more closely than the Medicaid language with
respect to who can make the request (proposed paragraph (c)(1)), and
how it should be considered and decided (proposed paragraph (c)(3)),
though we believe the MA and Medicaid requirements are functionally the
same. At paragraph (c)(2), we propose to include the more specific
language from the MA regulations at Sec. 422.570(b)(1) that the
request to expedite the appeal can be made orally or in writing. We
invite comments regarding alternative phrasing.
In paragraph (d), we propose rules regarding timeframes and notices
when resolving integrated coverage determinations. In paragraph (d)(1),
we propose to require that an applicable integrated plan send a written
integrated notice when the organization determination (standard or
expedited) is adverse to the enrollee. We propose to include text
specifically identifying as adverse determinations requiring a notice
any decision to authorize a service or item in an amount, duration, or
scope that is less than the amount requested or previously requested or
authorized for an ongoing course of treatment. We also propose to
include text specifying, consistent with Medicaid managed care
requirements (Sec. 438.404(c)(5)), that the applicable integrated plan
must send an integrated determination notice when it fails to make a
timely decision, since such a failure constitutes an adverse decision,
and that the enrollee may then request an integrated reconsideration.
The proposed notice would include information about the determination,
as well as information about the enrollee's appeal rights for both
Medicare and Medicaid covered benefits. Though integrating information
on Medicare and Medicaid appeal rights would be a new requirement if
this proposed requirement is finalized, we propose content requirements
for the notice that generally largely align with current requirements
in Medicaid (Sec. 438.404(b)) and MA (Sec. 422.572(e)). We also
propose that the notice be written in plain language and available in a
language and format that is accessible to the enrollee consistent with
1859(f)((8)(B)(iii)(III) of the Act.
In paragraph (d)(2), we propose timelines for sending this notice
that largely align with both existing Medicare and Medicaid
requirements. We propose, in paragraph (d)(2)(i)(A), to require that
applicable integrated plans send a notice of an integrated organization
determination at least 10 days before the date of action if a
previously authorized benefit is being reduced, suspended or
terminated, as is currently required for Medicaid managed care plans
under Sec. 438.404(c), with some exceptions in accordance with
Sec. Sec. 431.213 and 431.214. Exceptions under Sec. 431.213 include
circumstances where the enrollee cannot, or does not wish to, be
reached--for example, there exists factual information confirming the
enrollee's death or the enrollee is no longer eligible for services, or
if the State Medicaid Agency determines that
[[Page 55008]]
the beneficiary has been accepted for Medicaid services in another
jurisdiction. Exceptions under Sec. 431.214 allow for less advance
notice to the enrollee in cases of probable fraud. This standard for
the timing of these notices (within 10 days subject to specific
exceptions) is adopted from Medicaid and aligns with the timing for
enrollees to request (under Sec. 438.420) continuation of a previously
authorized benefit while the integrated reconsideration is pending
because it gives the enrollee enough time, upon receiving the notice,
to request that the benefit continue without a potential gap in the
benefit. We propose, in paragraph (d)(2)(i)(B), to require that
applicable integrated plans send the notice as expeditiously as the
enrollee's health condition requires but no later than 14 calendar days
from receipt of the request for a standard integrated organization
determination, and propose to permit extensions, in proposed paragraph
(d)(2)(ii), in circumstances that largely parallel those that exist in
Medicare and Medicaid currently. In paragraph (d)(2)(iii), we propose
requirements for notice in cases of extension which largely parallel
current MA and Medicaid requirements at Sec. 422.572(b)(2) and Sec.
438.404(c)(4)(i), respectively. Both MA and Medicaid currently require
that the health plan notify the enrollee of the delay and the right to
file a grievance. Section 422.631(d)(2)(iii)(A) as proposed largely
parallels Sec. 422.572(b)(2), which provides more specific direction
on timing of the notice. We are proposing to apply the MA requirement
that the enrollee be notified of the right to file an expedited
grievance in these instances. We also propose in paragraph
(d)(2)(iii)(B) regulatory text controlling when the notice of the
determination must be sent in cases where the applicable integrated
plan takes an extension.
In paragraph (d)(2)(iv)(A), we propose the deadline for issuing
notice of expedited integrated organization determinations. Both MA and
Medicaid require expedited organization determinations (or adverse
actions) within 72 hours of the request, with the possibility of
extending that timeframe by 14 calendar days. We propose, at paragraph
(d)(2)(iv)(B), to mirror the MA requirements (Sec. 422.570(d)), with
required procedures when an applicable integrated plan denies a request
for expediting an organization determination. In paragraph
(d)(2)(iv)(C) we propose to include requirements, which parallel MA
requirements (Sec. 422.572(d)), for applicable integrated plans when
obtaining necessary information from noncontract providers. These
requirements specify that the applicable integrated plan must reach out
to a noncontract provider within 24 hours of the initial request for an
expedited integrated organization determination. Though Medicaid
managed care regulations to not contain a similar requirement, Medicaid
managed care plans currently must resolve expedited appeals under the
same timeframes and, therefore, should already be reaching out to
providers for information necessary to process expedited appeals in a
similarly timely manner.
(7) Continuation of Benefits Pending Appeal (Sec. 422.632)
Section 50311(b) of the Bipartisan Budget Act of 2018 amended
section 1859(f) of the Act by creating a new paragraph (8)(B)(iv)
requiring that the unified appeals procedures we develop with respect
to all benefits under Medicare Parts A and B and Title XIX that are
subject to appeal under such unified procedures incorporate provisions
under current law and implementing regulations that provide
continuation of benefits pending appeal under Titles XVIII and XIX. We
interpret this provision as requiring CMS to apply continuation of
benefits to all Medicare Parts A and B and Medicaid benefits under our
proposed unified appeals processes. The statutory language ``with
respect to all benefits under parts A and B and title XIX subject to
appeal under such procedures'' modifies the verb ``incorporate.''
Therefore, we interpret the provision as requiring CMS to incorporate
statutory and regulatory provisions for continuation of benefits into
the unified appeal procedures for all Parts A and B benefits, and not
only those benefits that are already permitted to be continued under
current law (Medicaid benefits and limited Medicare benefits, as
described in more detail later in this section of the proposed rule).
We considered current laws and implementing regulations related to
continuation of benefits under Medicare and Medicaid and found that
Medicare's continuation of benefits provisions are of limited
relevance, but that there are significant Medicaid provisions that must
be incorporated in our integrated standards. Continuation of benefits
exists in very limited circumstances in Medicare currently. A Medicare
beneficiary can receive an extension of inpatient hospital stays when
the beneficiary appeals a notice of discharge to the Quality
Improvement Organization (QIO) under Sec. Sec. 405.1205 through
405.1208 and Sec. Sec. 422.620 and 422.622. We do not propose any
changes to the existing QIO process, as its specialized nature does not
lend itself readily to expansion to other services such as those
covered by Medicaid.
Medicaid's continuation of benefits provisions are considerably
more comprehensive, and we propose to incorporate them into this
unified appeals process. These Medicaid rules, found in Sec. Sec.
431.230 and 431.231 (general) and Sec. 438.420 (managed care), are
grounded in constitutional due process principles articulated in
Goldberg v. Kelly, 397 U.S. 254 (1970), that recognize the importance
of allowing people with limited financial resources to challenge a
decision prior to the decision taking effect. Under Sec. 438.420, a
Medicaid managed care plan is required, upon request of the enrollee,
to cover certain Medicaid benefits while an appeal is pending, provided
that: (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.
We also note that continuation of benefits has been included as
part of the integrated appeals process in the Financial Alignment
Initiative demonstrations, under processes that largely parallel what
we are proposing in these regulations. We request comment on our
interpretation of the statutory requirements related to continuation of
benefits pending appeal.
Accordingly, we propose that the existing standards for
continuation of benefits at Sec. 438.420 apply to applicable
integrated plans for Medicare benefits under Parts A and B and Medicaid
benefits in our proposed integrated appeals requirements at Sec.
422.632. Under our proposal, as is applicable to Medicaid managed care
plans currently, if an applicable integrated plan decides to stop (as a
termination or suspension) or reduce a benefit that the enrollee is
currently authorized to receive, the enrollee could request that the
benefit continue to be provided at the currently authorized level while
the enrollee's appeal is pending through the integrated
reconsideration. The enrollee would be required to make a timely
request for the continuation, as further detailed below.
We anticipate that this provision will simplify the appeals process
for both
[[Page 55009]]
plans and beneficiaries, as it will be unnecessary to determine which
ongoing benefits are subject to continuation pending appeal. This has
been our experience in the Financial Alignment Initiative
demonstrations. In addition, as we note in the Regulatory Impact
Analysis, relatively few Medicare benefits are continuing in nature,
and we therefore do not anticipate a significant financial cost related
to the implementation of this provision by applicable integrated plans.
We propose, at paragraph (a), a definition for ``timely files.''
This definition would mirror the definition at Sec. 438.420(a), with
minor revisions to make the text applicable to applicable integrated
plans instead Medicaid managed care plans.
We propose, at paragraph (b), to require a previously authorized
service covered under Medicaid or Medicare Part A or Part B, excluding
supplemental benefits as defined at Sec. 422.103, to be continued
pending an appeal of a termination of those services. We propose to
require that the continuation of these services as a covered benefit
would be conditioned on the same five criteria listed in Sec. 438.420
being met.
We propose, at paragraph (c), to require that an applicable
integrated plan continue such services pending issuance of the
integrated reconsideration. We note that for Medicaid managed care
plans that are not applicable integrated plans, continuation of these
services after the integrated reconsideration and pending resolution of
the state fair hearing is controlled by Sec. 438.420(c). Our proposal
for continuation of services pending appeal would provide a unified,
consistent rule for Medicaid and Medicare Part A and Part B benefits,
excluding supplemental benefits defined in Sec. 422.103, for the
duration of the unified appeals process proposed here for all plan
level appeals. Proposed Sec. 422.632(c)(2) therefore provides that
continuation of services ends when the applicable integrated plan
issues an adverse integrated reconsideration. If the applicable
integrated plan finds in favor of the enrollee, benefits would continue
in accordance with the favorable integrated reconsideration. In
proposed Sec. 422.632(c)(3), we propose requirements for Medicaid-
covered benefits to continue after the applicable integrated plan
issues an adverse integrated reconsideration, mirroring the
requirements currently in Medicaid managed care regulations (see Sec.
438.420(c)(2)). The enrollee must make the request and file for a state
fair hearing within 10 calendar days after the applicable integrated
plan sends the notice of the integrated reconsideration. We also
propose to mirror requirements from Sec. 438.420 for how long
Medicaid-covered benefits must continue by requiring that the benefits
continue until the enrollee withdraws the request for the state fair
hearing or until the state fair hearing decision is issued.
We considered alternative approaches to implementing benefits
pending appeal, and we believe integrating through the plan-level
reconsideration stage of the appeal process is the most feasible
approach at this time. The right for a Medicaid beneficiary to have
Medicaid benefits continue through a state fair hearing, which is the
second level of appeal for an enrollee, would not be impacted by this
proposal. The process that we propose for an enrollee's benefits to
continue during the state fair hearing process mirrors the current
process under Medicaid regulations at Sec. 438.420.
In proposed paragraph (d), we address whether an applicable
integrated plan can seek recovery for the costs of services provided
while an appeal is pending. Medicaid regulations allow states to
determine whether or not a plan, or the state, can seek recovery for
the costs of services provided pending appeal (Sec. 431.230(b)). If a
state permits such recovery under managed care, plans must inform
enrollees of this possibility (Sec. 438.420(d)). As noted in the
preamble to the 2016 final Medicaid managed care rule, such notices can
have the effect of deterring enrollees from exercising the right to
appeal.\14\ Moreover, Medicare's provision allowing benefits to
continue is limited, as noted earlier, to an extension of inpatient
hospital stays when the beneficiary appeals a notice of discharge to
the Quality Improvement Organization (QIO) under Sec. Sec. 405.1205
through 405.1208, and 422.620 and 422.622.\15\ Finally, in a number of
our Financial Alignment Initiative demonstrations, we and our state
partners have explicitly declined to allow MMPs to recover of the costs
of services provided pending appeal. Neither MMPs nor states have noted
any adverse impact on the costs of services provided pending appeal.
Therefore, in paragraph (d), we propose to prohibit recovery of the
costs of services provided pending the integrated reconsideration and,
for Medicaid-covered benefits, any state fair hearing, to the extent
that services were continued solely under Sec. 422.632, for all
applicable integrated plans and state agencies.
---------------------------------------------------------------------------
\14\ 81 FR 27512 (May 6, 2016).
\15\ We note that while regulations at 42 CFR 405.1200 through
405.1204 and 422.624 and 422.626 address appeal rights for Medicare
beneficiaries related to terminations of certain facility services
and potential continuation of services pending those appeals, those
regulations generally require the beneficiary to pay for services
received after the date and time designated on the termination
notice him or herself unless the beneficiary prevails on the appeal.
As an individual always has the right to choose to receive non-
covered services when bearing financial responsibility for those
services, we believe these scenarios are not truly continuations of
benefits pending appeal as the services might not be covered.
---------------------------------------------------------------------------
We considered several alternatives to this approach. We considered
proposing to use the same rule as Sec. 438.420(d) and applying it to
all services provided pending appeal by applicable integrated plans.
Under this alternative, a state's Medicaid recoupment policy would also
apply to Medicare benefits provided by an applicable integrated plan
pending appeal. However, there is no recoupment provision under
Medicare that parallels the recoupment process under Medicaid managed
care. As we noted earlier, continuation of services without imposing
financial liability on the enrollee in Medicare exists in the narrow
circumstances related to extension of inpatient hospital stays when the
beneficiary appeals a notice of discharge to the Quality Improvement
Organization (QIO). If an enrollee files a timely request for QIO
review of the discharge, the enrollee is not responsible for the costs
of the hospital services during the QIO review, even if the QIO
ultimately finds that the hospital stay should not be continued (Sec.
422.422(f)). Developing a recoupment policy in Medicare, and
communicating it to enrollees, could become administratively complex
while offering little benefit to enrollees or plans, considering the
limited financial resources of dually eligible enrollees.
We also considered adopting the Medicaid rule at Sec. 438.420(d)
only for services provided under Title XIX--that is, Medicaid-covered
services. This approach would preserve state flexibility, but it would
risk creating administrative complexity for plans and confusion for
enrollees, as it would necessitate differentiating between services for
which financial recovery was possible and those for which it was not.
We invite comments on our proposed approach to prohibit the recovery of
the costs of services provided pending appeal, our considered
alternatives, and any other possible approaches.
[[Page 55010]]
(8) Integrated Reconsiderations (Sec. 422.633)
In proposed Sec. 422.633, we lay out our proposed provisions for
an integrated reconsideration process for applicable integrated plans.
As with other provisions, we compared relevant Medicare and Medicaid
provisions, and where they differ, we chose to adopt the policy that is
most protective of the beneficiary.
In paragraph (a), we propose that applicable integrated plans may
only have one plan level of appeal. This provision is consistent with
Sec. 438.402(b), which prohibits more than one plan level of appeals,
and Sec. 422.590, which permits only one internal reconsideration
before an adverse decision is subject to review by the independent
review entity.
In paragraph (b), we propose to adopt a rule similar to Sec.
438.402(c)(1)(i)(B) regarding the permissibility of external medical
reviews: Medicaid managed care plan enrollees may be offered an
opportunity to elect external medical review under a state external
review process. Under our proposal, the ability to elect external
medical review would apply only to Medicaid covered services that are
the subject of an adverse integrated reconsideration issued by an
applicable integrated plan because D-SNPs, like all MA plans, are not
subject to state external review procedures.\16\
---------------------------------------------------------------------------
\16\ Section 1856(b)(3) of the Act preempts state regulation of
Medicare Advantage plans.
---------------------------------------------------------------------------
In paragraph (c), we propose a right for each enrollee, and their
representatives, to review the medical records in the enrollee's case
file, consistent with the protection for Medicaid enrollees under Sec.
438.406(b)(5). We believe that this protection for Medicaid enrollees
in a managed care plan is appropriate for dually eligible enrollees and
should apply to applicable integrated plans. In particular, we propose
adopting Medicaid's provision prohibiting plans from charging for
copies of records, as we believe the policy applicable for MA plans,
which permits plans to charge beneficiaries reasonable copying fees, is
inappropriate and less protective of dual eligible individuals, who
typically have limited income. We invite comments on this proposal.
In paragraph (d)(1), we propose timelines for filing for a standard
integrated reconsideration that, consistent with both MA (at Sec.
422.582(b)) and Medicaid managed care (at Sec. 438.402(c)(2)(ii))
regulations, would require that an integrated reconsideration be filed
within 60 days of the date of the denial notice. We propose, in
paragraph (d)(2), that oral inquiries seeking to make an integrated
reconsideration be treated as integrated reconsiderations; this is
generally consistent with Sec. 438.406(b)(3), which we find to be the
more protective of enrollees than the MA provision at Sec. 422.582(a)
which gives MA plans discretion in deciding to accept oral requests for
reconsideration. We believe that applying the Medicaid rule to
applicable integrated plans is appropriate because initiating an
integrated reconsideration orally may be the easiest way for enrollees
to start the integrated reconsideration process quickly, and timely
filing can be especially important to ensure aid continues pending the
integrated reconsideration resolution under proposed Sec. 422.632. We
are not proposing to include the language in Sec. 438.406(b)(3)
requiring beneficiaries to provide written confirmation of oral
requests because such a requirement would be inconsistent with MA
policy that directs plans that do accept oral requests for
reconsideration to provide written confirmation to the beneficiary (see
Medicare Managed Care Manual Chapter 13, section 70.2). We propose, in
paragraph (d)(3), to include current requirements from MA (at Sec.
422.582(c)) that allow for extending the timeframe for an enrollee, or
a physician acting on behalf of an enrollee, to file a late
reconsideration. As in MA, we propose to allow late filing when a party
to the integrated organization determination or a physician acting on
behalf of the enrollee can show good cause for the extension and makes
the request in writing. We find that this is an important beneficiary
protection that should be applied to our proposed integrated process.
In paragraph (e), we propose to address procedures for filing
expedited integrated reconsiderations. Both MA (at Sec. 422.584) and
Medicaid (at Sec. 438.408(b)(3)) regulations permit filing of
expedited appeals. The MA regulation provides greater detail regarding
how plans are to consider requests for expedited reconsiderations. The
proposed language in paragraphs (e)(1), and (e)(2) aligns with Sec.
422.584 in permitting the enrollee or health care provider to file a
written or oral request for an expedited reconsideration. The proposed
language in paragraph (e)(3) aligns with Sec. 422.584 in setting the
standard that the applicable integrated plan must use in deciding
whether to expedite the integrated reconsideration. We invite comments
regarding whether additional specificity or harmonizing between
Medicare and Medicaid's requirements is needed in this area.
In paragraph (e)(4), we propose notice requirements related to
requests for expedited integrated reconsiderations. We propose
requirements that parallel Medicaid managed care requirements for
notice to the enrollee when the request for an expedited integrated
reconsideration is denied (Sec. 438.410(c)(2))--specifically, that the
plan must give prompt oral notice and written notice within 2 calendar
days and transfer the matter to the standard timeframe for making an
integrated reconsideration (that is, the timeframe specified in
paragraph (f)(1)). The MA requirements for notice, when an enrollee's
request for an expedited integrated reconsideration is denied, are for
the plan to provide prompt oral notice and, subsequently, written
notice within 3 calendar days (Sec. 422.584(d)(2)). We find that the
Medicaid managed care requirements are more protective for enrollees by
requiring faster notification when the request to expedite is denied.
We propose to apply the MA requirements for what applicable integrated
plans must include in the written notice to enrollees when the request
to expedite the integrated reconsideration is denied (Sec.
422.584(d)(2)). The MA requirements for the contents of this notice are
more extensive than the Medicaid managed care requirements (Sec.
438.410(c)(2)). We find the additional content requirements to be more
protective of enrollees by providing them more information on options,
and also helping to make the process more navigable for enrollees.
In paragraph (e)(5) we propose to include requirements, which
mirror MA requirements (Sec. 422.590(d)(3)), for applicable integrated
plans when obtaining necessary information from noncontract providers.
These requirements specify that the applicable integrated plan must
reach out to a noncontract provider within 24 hours of the initial
request for an expedited integrated reconsideration. Though Medicaid
managed care regulations do not contain a similar requirement, Medicaid
managed care plans currently must resolve expedited appeals under the
same timeframes and, therefore, should already be reaching out to
providers for information necessary to process expedited appeals in a
similarly timely manner.
In paragraph (f), we propose timelines and procedures for resolving
an integrated reconsideration request. We propose specific requirements
for applicable integrated plans. Both MA (at Sec. 422.590(a)) and
Medicaid (at Sec. 438.408(b)(2)) require resolution of
[[Page 55011]]
pre-service standard appeal requests within 30 calendar days. We
propose the same rule in paragraph (f)(1), with the addition of a
provision mirroring Sec. 422.590(a)(2), that the integrated
reconsideration decision be issued as expeditiously as the enrollee's
health requires but no later than 30 calendar days from the date the
applicable integrated plan receives the request for the integrated
reconsideration.
However, MA and Medicaid managed care differ in the timeframes
within which plans must resolve post-service appeals (that is, appeals
related to payment requests). Medicaid regulations at Sec.
438.408(b)(2) do not distinguish between pre-service and post-service
appeals--all appeals must be resolved within 30 calendar days. In
contrast, while MA regulations require that plans resolve standard
reconsiderations within 30 calendar days for pre-service appeals, plans
have 60 days to resolve post-service denials of payment. Although we do
not believe the volume of appeals for payment is high for individuals
dually eligible for Medicare and Medicaid, it is more protective for
enrollees to have all integrated reconsiderations resolved in 30
calendar days, particularly given what may be significant financial
needs for the individual. Similarly, we are not proposing to
incorporate into the unified appeals process MA's regulation that
expedited organization determinations are not required in post-service
payment cases. Again, we do not believe the volume of post-service
cases that otherwise qualify under the requirements for an expedited
integrated organization determination would be high, so we do not
expect this to be a burden to D-SNPs that would be required to comply
with unified appeals requirements we propose here. There may be
circumstances in which an enrollee's financial need is particularly
pressing. Accordingly, in Sec. 422.633(f)(1), we propose to require
that all integrated reconsiderations be resolved within 30 calendar
days of receipt similar to the Medicaid managed care regulations. We
considered applying the approach taken in the MA regulations that gives
MA plans more time to resolve post-service payment cases so that plans
can prioritize cases where an enrollee is waiting for a service to
start or an item to be provided. However, given the financial
circumstances of enrollees in applicable integrated plans, we propose
requiring the same resolution timeframe for all integrated
reconsideration to ensure prompt repayment. We invite comments on this
proposal--both on the overall 30 calendar day period and on permitting
expedited post-service integrated reconsideration--as we recognize this
would constitute a change to current D-SNP operations.
In paragraph (f)(2), we propose to establish the timeframes for
expedited reconsiderations. Both MA (at Sec. 422.590(d)(1)) and
Medicaid (at Sec. 438.408(b)(3)) allow 72 hours for resolution of an
expedited reconsideration or appeal. We propose to adopt the same rule
for integrated reconsiderations. We also propose to apply the Medicaid
managed care requirement (at Sec. 438.408(d)(2)(ii)) by requiring that
applicable integrated plans make reasonable efforts to give enrollees
oral notice of the resolution in expedited cases, in addition to
sending the written notice within 72 hours of receipt of the request.
In paragraph (f)(3)(i), we propose criteria for an applicable
integrated plan to extend the timeframe for resolving either a standard
or expedited reconsideration. MA (at Sec. 422.590(e)) and Medicaid (at
Sec. 438.408(c)) have similar rules, both allowing 14-day extensions
upon request of the enrollee (or the enrollee's representative) and
when the plan can demonstrate an extension is in the enrollee's
interest. We propose to adopt a similar standard here, generally using
the standard in Sec. 438.408(c) that the plan must show that the
extension is in the enrollee's interest and that the information is
necessary. We also propose to use the MA standard that the timeframe
may be extended if there is a need for additional information and there
is a reasonable likelihood that receipt of such information would lead
to approval of the request, as this standard is more protective of the
enrollee. Using this standard, an applicable integrated plan would be
prohibited from extending the deadline for its integrated
reconsideration in order to gather information to justify continuing
its original denial of coverage. We request comments regarding whether
additional specificity is needed.
In paragraph (f)(3)(ii), we propose requirements for the notice
that applicable integrated plans must send to enrollees when the plan
extends the timeframe for making its determination, in accordance with
the requirements in this paragraph. We propose to require that the
applicable integrated plan make reasonable efforts to give the enrollee
prompt oral notice and give the enrollee written notice within 2
calendar days. These requirements align with current Medicaid managed
care regulations at Sec. 438.408(c)(2). The MA regulation requires
that the plan notify the enrollee in writing as expeditiously as the
enrollee's health condition requires, but no later than the expiration
of the extension period (Sec. 422.590(e)(2)). We find the Medicaid
managed care requirements to be more protective to enrollees since they
are likely to provide faster notice to the enrollee of the
determination. We also propose that the notice of the extension include
the reason for the delay and inform the enrollee of the right to file
an expedited grievance if the enrollee disagrees with the decision to
extend the timeframe. Both Medicaid managed care and MA require similar
information. However, only MA requires information on an expedited
grievance process, since only MA includes an expedited grievance
process. Since we are proposing to include an expedited grievance
process, we are proposing to require information about that process in
this notice.
In paragraph (f)(4), we propose requirements for providing
appellants with notices regarding the resolution of reconsiderations.
We propose to require that applicable integrated plans send notices
within the resolution timeframes established in this section for all
integrated reconsideration determinations. Medicaid managed care
regulations require notices of all determinations. MA regulations will
no longer, effective for the 2019 plan year, require MA plans to send
written determinations in cases where the determination is fully or
partially unfavorable to the enrollee because MA enrollees will still
receive a notice from the independent entity once the MA plan forwards
the case for fully or partially unfavorable determinations (see 83 FR
16634 through 16635). We believe that requiring applicable integrated
plans to send notices for all integrated reconsideration determinations
is in line with the principles identified in section 1859(f)(8)(B) of
the Act for a unified process, and timely, clear notification for
enrollees. We also propose to include language requiring that the
notice be written in plain language and available in a language and
format that is accessible to the enrollee consistent with section
1859(8)(B)(iii)(III) of the Act. We also propose, in paragraphs
(f)(4)(i) and (ii), to adopt the standards similar to those governing
the content of a notice found in Sec. 438.408(e)--namely, that the
plan must provide a notice of the integrated reconsideration for an
adverse decision that includes the reason for the decision and the date
of completion. We propose in paragraph (f)(4)(ii)(A) that, for
integrated notices not resolved wholly in the enrollee's favor, the
notice include an explanation
[[Page 55012]]
of the next level of appeal under both Medicare and Medicaid, and what
steps the enrollee must take to further pursue the appeal. Our
expectation is that the integrated notice will enable the enrollee to
understand which program covers the benefit at issue. We also propose
in paragraph (f)(4)(ii)(B) that the notice include specific information
about the ability to request continuation of Medicaid-covered benefits
pending appeal.
(9) Effect (Sec. 422.634)
We propose, at Sec. 422.634(a), to use the same standard as in
existing MA and Medicaid regulations related to a plan's failure to
made a timely determination. If an applicable integrated plan fails to
make a timely determination at any point in the appeals process (for an
integrated organizational determination or an integrated
reconsideration), that failure would constitute an adverse
determination, such that the enrollee could move forward with the next
level of appeal procedures (see Sec. Sec. 438.400(b)((b),
438.402(c)(1)(i)(A), 438.408(c)(3), 422.568(f), and 422.572(f)).
We propose, at Sec. 422.634(b), to establish the next steps in the
appeals process if the enrollee receives an adverse decision from the
applicable integrated plan on the integrated reconsideration. For cases
involving Medicare benefits, we propose, for applicable integrated
plans at Sec. 422.634(b)(1)(i), the same processes as currently exist
in MA at Sec. 422.590(a)(2) and (d)(4) for forwarding the case file
and timing. In Sec. 422.634(b)(1)(ii) and (iii), we propose to mirror
the MA regulations (Sec. 422.590(a)(2) and (d)(3)) with requirements
for applicable integrated plans to forward the case file to the
independent entity.
At Sec. 422.634(b)(2), we propose that for cases involving
Medicaid benefits, the enrollee may initiate a state fair hearing no
later than 120 calendar days from the date of the applicable integrated
plan's notice of resolution. This proposal would, in effect, impose the
same process on appeals from integrated reconsiderations related to
Medicaid coverage as applies under Sec. 438.408(f)(2) and (3). We also
propose to include the requirement that a provider who has not already
obtained the written consent of an enrollee must do so before filing a
request for a state fair hearing, in accordance with existing Medicaid
requirements, since our proposed regulations would only apply new
processes and requirements through the integrated reconsideration.
We also propose to parallel, at proposed Sec. 422.634(c), MA
regulation language at Sec. 422.576 clarifying that determinations are
binding on all parties unless the case is appealed to the next
applicable level of appeal. We also propose to specify that this means
that, in the event that an enrollee pursues an appeal in multiple
forums simultaneously (for example, files for an external state medical
review and an integrated reconsideration with the applicable integrated
plan, and the integrated reconsideration decision is not in the
enrollee's favor but the external state medical review decision is), an
applicable integrated plan would be bound by, and must implement,
decisions favorable to the enrollee from state fair hearings, external
medical reviews, and independent review entities (IRE).
We propose, at Sec. 422.634(d), to parallel Medicaid requirements,
from Sec. 438.424(a), detailing how quickly services must be put in to
place for an enrollee after he or she receives a favorable decision on
an integrated reconsideration or state fair hearing. We propose to
include the current Medicaid managed care requirement that, if a
decision is favorable to the enrollee, the applicable integrated plan
must authorize or provide the disputed benefit as expeditiously as the
enrollee's health condition requires but no later than 72 hours from
the date it receives notice reversing the determination. MA's rule for
effectuation of a standard organization determination at Sec.
422.618(a) also requires effectuation as expeditiously as the
enrollee's health requires, but allows a maximum of 30 days. We believe
the shorter, 72-hour maximum is more protective of the needs of dually
eligible beneficiaries. We also note that a 72-hour effectuation period
is the same as Medicare's timeframe for an expedited determination at
Sec. 422.619(a), so that plans should be accustomed to effectuating
decisions under this timeframe. Finally, we also propose in this
paragraph to maintain the same effectuation timelines for reversals by
the Medicare independent review entity as apply to other MA plans.
We propose, at Sec. 422.634(e), for Medicaid-covered benefits, to
parallel Medicaid requirements from Sec. 438.424(b) governing how
services that were continued during the appeal must be paid for, if the
final determination in the case is a decision to deny authorization of
the services. For Medicare-covered services, we propose that the
applicable integrated plan will cover the cost of the benefit.
(10) Unifying Medicare and Medicaid Appeals Subsequent to Integrated
Reconsideration
The new section 1859(f)(8)(B)(ii) of the Act directs us to include,
to the extent we determine feasible, consolidated access to external
review under an integrated process. We interpret ``external review'' in
this statutory provision as meaning review outside the plan, including
by a government agency or its designee. For MA, this includes the
independent review entity (IRE) and ALJ review described in Sec. Sec.
422.592 through 422.602. For Medicaid, this includes the state fair
hearing process described in Part 431 Subpart E, as well as any
additional external review offered under state law.
A unified and integrated appeals process subsequent to a plan
decision could be significantly simpler for beneficiaries to navigate,
as they would not have to determine whether they should be pursuing a
Medicare appeal, a Medicaid appeal, or both. Such a process could
reduce burden for plans, states, and the federal government by reducing
the number of duplicative appeals. However, unifying D-SNP and Medicaid
appeals subsequent to the reconsideration level also presents
considerable challenges. Currently, once a D-SNP or Medicaid managed
care plan makes a final decision on an appeal, the federally-
administered Medicare and state-administered Medicaid appeals processes
are entirely separate. Although they have some common principles, such
as ensuring access to an independent administrative hearing, they
differ in many respects. Specific differences include:
Reconsideration by an independent entity: Section
1852(g)(4) of the Act, which is implemented in MA rules at Sec. Sec.
422.592 through 422.596, requires that all adverse plan appeal
decisions be reviewed by an independent entity. Under the regulations,
this review is on the record and happens automatically for Part C
claims, as the MA plan is required to forward any adverse
reconsideration to the IRE. This IRE review takes place before a
beneficiary can request an administrative hearing before an
administrative law judge but, because each adverse reconsidered
determination is automatically forwarded to the IRE, the enrollee is
not required to initiate these reviews. In the Medicaid managed care
context, there is no federal regulation or statute that similarly
requires a review by an external entity before access to a governmental
review; pursuant to Sec. Sec. 438.402(c)(1)(i)(B) and
[[Page 55013]]
438.408(f)(1)(ii), a state may make a voluntary external medical review
process available to enrollees in a Medicaid managed care plan so long
as the process does not interfere with enrollees' right to proceed to a
state fair hearing.
Immediate access to an administrative hearing: The
applicable Medicaid managed care program regulations (Sec. Sec.
438.402(c)(1)(i)(B) and 438.408(f)) specify that any external review
cannot be required before allowing a beneficiary to proceed to the
state fair hearing, so that the state fair hearing process is available
immediately following the Medicaid managed care plan's appeal
determination if the enrollee elects.
Amount in controversy: Section 1852(g)(5) of the Act
requires that an amount in controversy be met for a hearing before the
Secretary on appeal and for judicial review. In 2018, those thresholds
are $160 for an Administrative Law Judge hearing and $1,600 for
judicial review.\17\ Medicaid has no similar provision.
---------------------------------------------------------------------------
\17\ 82 FR 45592 (September 29, 2017).
---------------------------------------------------------------------------
Reviewing agency and subsequent review: Medicaid program
rules at Part 431 Subpart E (which are not limited to Medicaid managed
care plans but also control appeals in the Medicaid fee-for-service
context) require that beneficiaries always have the right to request a
hearing before the state agency for a review of a denial of service
(Sec. 431.205(b)(1)) or for a reduction, termination, or reason
described at Sec. 431.220(a). Medicaid hearings are held by the state
Medicaid agency or, in limited circumstances, its designee. Subsequent
review procedures vary based on state law. Section 1852(g)(5) of the
Act provides that a MA enrollee is entitled, if the amount in
controversy threshold is met, to a hearing before the Secretary to the
same extent as is provided in section 205(b) of the Act. The MA
regulations (at Sec. Sec. 422.562(b)(4)(iv)-(vi) and (d), and
Sec. Sec. 422.600 through 422.616) implement this requirement by
providing for appeals to be made to the Office of Medicare Hearings and
Appeals and Medicare Appeals Council using substantially the same
procedures and processes used for appeals of claims denials under Part
A and Part B of Medicare.
Timelines and procedural rules: Medicaid's procedural
rules on matters such as timelines and location of a hearing vary by
state and may differ from the rules applicable to MA. For example,
Medicaid rules at Sec. 431.224 allow for expedited fair hearing
hearings under certain circumstances, whereas there is no equivalent
expedited hearing process at the Medicare ALJ level for Part C/MA
appeals.
In addition, our authority to unify appeals procedures under
Medicare and Medicaid and to provide consolidated access to external
review under section 1859(f)(8)(B) of the Act cannot be used to
diminish any appeal rights under Medicare or Medicaid. In the context
of establishing the unified procedures for appeals and grievances, the
statute provides authority to waive only section 1852(g)(1)(B) of the
Act (which imposes certain notice requirements for MA organizations)
and directs unification--rather than amendment or elimination--of
procedures under sections 1852(f), 1852(g), 1902(a)(3), 1902(a)(5), and
1932(b)(4) of the Act. In many ways, those statutory provisions do not
direct specific procedures but provide some measure of discretion in
effectuating appeal rights. But where those statutory provisions are
specific, we generally do not have authority under section
1859(f)(8)(B) of the Act to waive the specific requirements in
establishing unified procedures and processes. In addition to the
statutory differences we have already outlined earlier, section
1852(g)(5) of the Act providing Medicare beneficiaries with an
opportunity for a hearing before the Secretary, and the analogous
provision at section 1902(a)(3) of the Act providing Medicaid
beneficiaries with a hearing before the state Medicaid agency, are
rights that must be met and present challenges in establishing a
consolidated, unified, post-plan appeals process. We believe that a
state-level unified appeals process to adjudicate both Medicare and
Medicaid claims would satisfy section 1902(a)(3) of the Act in
providing Medicaid beneficiaries with access to a state fair hearing.
However, to comply with section 1852(g)(5) of the Act, such a system
would need to include a pathway for a federal review of Medicare
claims, in a manner that provides a hearing before the Secretary.
Conversely, a federal-level unified appeals process would satisfy
section 1852(g)(5) of the Act but would need to include a pathway for
an enrollee to elect additional state agency review of Medicaid claims.
Finally, we believe as a practical matter that any entity adjudicating
cases in a unified process outside its traditional jurisdiction (that
is, a state entity reviewing Medicare claims or a federal entity
reviewing Medicaid claims) should be subject to some additional review
to ensure that its decisions were consistent with the applicable law
(that is, federal Medicare and state Medicaid criteria for benefits
coverage).
Based on these complexities, we believe it is not feasible to
propose a unified post-plan appeals process (that is, adjudication of
appeal subsequent to an applicable integrated plan's integrated
reconsideration of an initial adverse determination) at this time.
Instead we ask for comments on viable paths forward given the
constraints presented by the statutory mandates for the MA and Medicaid
appeals processes and our experience gained through demonstrations. We
hope to propose the establishment of a unified post-plan appeals
process in a future rulemaking, based on comments from this request for
information and additional experience. We discuss our experiences and
key areas for comment below.
Our sole experience with a unified appeals process subsequent to
the plan's final reconsideration of an initial benefit denial operates
under demonstration authority at the state level through a partnership
between CMS and the state of New York as part of the Financial
Alignment Initiative capitated model demonstrations. The New York
Financial Alignment Initiative demonstration, called Fully Integrated
Duals Advantage (FIDA), includes a fully integrated appeals process for
appeals from Medicare-Medicaid Plans (MMPs) authorized under section
1115A waiver authority.\18\ We note that this model was established
under demonstration authority prior to enactment of section
1859(f)(B)(8) of the Act, and some aspects of the model may not be
fully consistent with the provisions of Titles XVIII and XIX as they
would operate under a unified process implemented under the new
statute. In the FIDA integrated process, all adverse decisions by FIDA
MMPs, regardless of amount in controversy, are automatically forwarded
to a specialized unit of the New York administrative hearing agency
that conducts state Medicaid fair hearings. This specialized unit has
staff trained in both Medicare and Medicaid coverage rules, schedules
each denial for a hearing, and applies both Medicare and Medicaid
coverage criteria in reviewing the decision. Decisions affirming an
MMP's denial may be appealed to the federal Departmental Appeals
Board's Medicare Appeals Council, thereby ensuring an
[[Page 55014]]
opportunity for federal review of Medicare claims.
---------------------------------------------------------------------------
\18\ Section 2.13 of the FIDA contract, available at https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/FinancialAlignmentInitiative/Downloads/NYFIDAContract01012018.pdf.
---------------------------------------------------------------------------
Our experience with the New York FIDA unified appeals process
suggests that any procedures we establish for a unified post-plan
appeals process should be available as an option for states to
implement in partnership with CMS, rather than a nationwide
requirement. The New York FIDA experience has taught us that operating
a unified process requires considerable commitment, planning, and
coordination by both CMS and the state Medicaid agency, as well as from
other agencies that are part of the administrative hearing and review
process for Medicare and Medicaid (in this case, the New York state
hearing agency and the federal Departmental Appeals Board (DAB)).
Although models other than the New York FIDA model are feasible, any
unified adjudication entity for D-SNP appeals subsequent to the plan's
reconsideration would need to administer its own procedures and be
familiar with the substance of both Medicare and state-specific
Medicaid coverage rules. Given the resources and commitment needed, we
anticipate that only a limited number of states would wish to pursue a
unified system with CMS for appeals processes following the decisions
by applicable integrated plans. In addition, based on our experience
with the Financial Alignment Initiative demonstrations in other states,
we believe an appeals system that is integrated at the plan level but
which diverges subsequently can also be effective at ensuring
appropriate review of plan decisions. Therefore, we believe that
mandating a unified process subsequent to reconsideration for all
states would be unwise and likely infeasible.
We also believe that any post-plan appeals process should be
limited to appeals of decisions made by applicable integrated plans as
we propose to define them in Sec. 422.561. We believe the integrated
organization determination and integrated reconsideration processes we
propose in Sec. Sec. 422.631 and 422.633 lend themselves to an
integrated post-plan appeals process much more than a system that
attempts to integrate appeals made by separate MA and Medicaid managed
care plans.
Any regulation to establish a post-plan unified appeals process
would need to address the following misalignments in particular:
Harmonizing the Medicare Advantage requirement
for an external independent review with Medicaid's prohibition on
additional levels of administrative review between a plan decision and
a state fair hearing: The approaches to post-plan review do not align
neatly across Medicare Advantage and Medicaid managed care. Section
1852(g)(4) of the Act (governing Medicare Advantage appeals processes)
requires that CMS contract with an independent external entity to
conduct an external review of all adverse reconsiderations. CMS has
implemented this provision at Sec. 422.592 by requiring an automatic
referral of adverse plan reconsiderations to the IRE for an
administrative review. In the appeals structure for Medicaid managed
care plans, a plan's adverse action is not reviewed automatically, but
beneficiaries may request a fair hearing before the state Medicaid
agency (or, in limited cases, its designee) immediately following a
plan's decision, under procedures described in Part 431 Subpart E.
Requiring an additional level of external review for all integrated
appeals prior to allowing a state fair hearing would be inconsistent
with Medicaid policy, as we have only permitted establishment of
external medical reviews for Medicaid managed care plans if such
reviews do not impede access to a state fair hearing (see, for example,
Sec. 438.408(f)(1)(ii) and discussion at 81 FR 27518 (May 6, 2016)).
We are concerned that having a requirement for external review of all
adverse integrated reconsiderations before access to the state fair
hearing would impede dually eligible beneficiaries' timely access to a
fair hearing. However, allowing beneficiaries to proceed directly to a
governmental hearing to address Medicare-related issues without prior
external review could be inconsistent with the MA statutory requirement
for independent, external review. Furthermore, if the review, be it
external or by state fair hearing, were not automatic, then an adverse
reconsideration might not be reviewed at all, which would be
inconsistent with protection provided by the automatic referral in
Sec. 422.592. We do not believe either a purely Medicare-based or
Medicaid-based procedure is desirable in a unified post-plan appeals
process.
We have considered one approach that could accommodate these
constraints. Under this potential approach, a state entity with
expertise in both Medicare and Medicaid coverage rules would review all
adverse integrated reconsiderations issued by the plan. This entity
would conduct its review in the form of an automatic state fair hearing
consistent with Medicaid hearing procedures (such as the opportunity to
present evidence), as is done in the New York FIDA demonstration. The
automatic fair hearing would also constitute the independent external
review required by section 1852(g)(4) of the Act. In order to comply
with the statute, CMS and the state entity would have to enter into a
contract to perform the independent review. Following this state fair
hearing, appeals regarding Medicare-related issues would be subject to
additional appeal rights, but as we discuss below, operationalizing
those rights presents challenges as well.
We invite comments on the feasibility and desirability of this
approach. We are particularly interested in whether there are
instructive analogous examples of state-federal contracting that
successfully demonstrate states performing a task subject to federal
oversight. We also seek input regarding any advantages and
disadvantages to providing the automatic review in the form of a state
fair hearing. Finally, we welcome suggestions for alternative models
that could harmonize the MA and Medicaid managed care requirements
while maintaining compliance with all statutory provisions.
Preserving the right to hearing before the
Secretary: Section 1852(g)(5) of the Act requires the opportunity for
Medicare beneficiaries to have a hearing before the Secretary when an
amount in controversy threshold is met. In order to preserve that
right, a unified process would need to allow a beneficiary whose appeal
is unsuccessful at the independent review level to request a hearing
before the Secretary (presumably through the Office of Medicare
Hearings and Appeals (OMHA)) when an appeal involves a Medicare item or
service (meaning a Part A benefit, Part B benefit, or supplemental
benefit offered under the Medicare Advantage contract) meeting the
amount in controversy threshold. But this appeal level would not be
available for appeals of Medicaid-based cases or for Medicare cases not
meeting the amount in controversy. In effect, this would mean
beneficiaries would need to split their cases into separate Medicare
and Medicaid pathways if they wished to seek a hearing before the
Secretary for their Medicare claims meeting the amount in controversy.
In addition, it would essentially create the possibility for two
hearings: First an automatic integrated independent review and fair
hearing at a state-level integrated entity, followed by an optional
Medicare-only hearing at OMHA for Medicare matters meeting the amount
in controversy threshold. Although such a process could be
[[Page 55015]]
operationalized, we believe it might also be confusing to beneficiaries
and inconsistent with the goal of a simpler unified appeals process. We
therefore seek comments how best to preserve beneficiaries' rights
under section 1852(g)(5) of the Act and simultaneously establish a
unified process.
Pathways for subsequent review: We seek input on
the related question of how to structure other forms of subsequent
review for a unified post-plan appeal. Any unified procedure must
preserve both state-specific avenues for further review of Medicaid-
related fair hearing decisions (for example, additional administrative
review and state court review) and ensure that Medicare-related
decisions are reviewable consistent with section 1852(g)(5) of the Act
(for example, review by the Medicare Appeals Council and federal
judicial review under certain circumstances). We believe that
maintaining all these routes of appeal would mean that a unified case
would eventually have to be separated into Medicaid and Medicare
components, which could be difficult for beneficiaries and plans to
navigate. We invite comments regarding how to approach this problem. We
are considering providing state Medicaid agencies with the authority to
delegate review of a state fair hearing decision to a federal entity
(at state option and only with the federal entity's consent) in order
to keep the unified appeal together. This is the approach in the New
York FIDA demonstration, where the Medicare Appeals Council can review
Medicaid aspects of a FIDA decision. Such an approach may be
technically feasible, but we seek input regarding the advantages and
disadvantages of such a delegation.
Specificity of rulemaking: Depending on the
resolution of these issues in developing a unified post-plan appeals
process, additional federal rulemaking is likely to be necessary to
amend or create exceptions to the current MA requirements for IRE
review and the governmental administrative appeals process (see
Sec. Sec. 422.592 through 422.619). In addition to statutory
requirements for rulemaking (for example, the Administrative Procedure
Act and section 1871 of the Act), it would also be necessary to ensure
that all stakeholders have an opportunity to review and comment on the
proposal. However, establishing a specific process in federal
regulation constrains our ability to accommodate state-specific
flexibility. Some flexibility is possible: For example, timelines for
review by an independent entity are not established by Medicare
regulation. Timelines for a unified independent review and fair hearing
could therefore also vary by state to reflect state-specific fair
hearing rules. But any substantial variation that affected appeal
rights for MA (specifically D-SNP) enrollees might be subject to
additional federal rulemaking. For example, a model that would limit
unified post-plan appeals to only certain benefits (for example,
services like home health and durable medical equipment where Medicare
and Medicaid have differing coverage rules), would be subject to
additional rulemaking. We seek comment regarding what aspects of a
unified post-plan appeals process would necessitate state-specific
flexibility, including discussion of whether any of those aspects would
implicate rights under MA statute or would otherwise necessitate
additional federal rulemaking.
In summary, we believe that establishment of a unified post-plan
appeals process may be feasible in the future if we can address these
issues, and we believe that such a process could offer benefits to
beneficiaries, plans, states, and the federal government. We welcome
feedback from all stakeholders on the issues raised earlier, as well as
any others pertaining to a post-plan appeals process.
(11) Conforming Changes to Medicare Managed Care Regulations and
Medicaid Fair Hearing Regulations (Sec. 422.562, Sec. 422.566, Sec.
438.210, Sec. 438.400, and Sec. 438.402)
We propose a number of changes to Medicaid managed care, Medicaid
fair hearing, and Medicaid single state agency regulations to conform
with our proposed unified grievance and appeals provisions. Following
is a summary of these proposed changes.
In Sec. 422.562(a)(1)(i) and (b), we propose to add cross
references to the proposed integrated grievance and appeals regulations
along with new text describing how the provisions proposed in this rule
for applicable integrated plans would apply in place of existing
regulations.
In Sec. 422.566, we propose to add additional language to
paragraph (a) to establish that the procedures we propose in this rule
governing integrated organization determinations and integrated
reconsiderations at proposed Sec. 422.629 through Sec. 422.634 apply
to applicable integrated plans in lieu of the procedures at Sec. Sec.
422.568, 422.570, and 422.572.
In Sec. 438.210(c) and (d), we propose to add cross
references to the proposed integrated grievance and appeals regulations
along with new text describing how the provisions proposed in this rule
for applicable integrated plans would apply in place of existing
regulations to determinations affecting dually eligible individuals who
are also enrolled in a D-SNP with exclusively aligned enrollment, as
those terms are defined in Sec. 422.2. In Sec. 438.210(f), we propose
to make these Medicaid changes applicable to applicable integrated
plans no later than January 1, 2021, but, consistent with our
discussion earlier on the effective dates of our proposed unified
appeals and grievance procedures overall, we would not preclude states
from applying them sooner.
In Sec. 438.400, we propose adding a new paragraph (a)(4)
to include the statutory basis for the proposed integration regulations
(section 1859(f)(8) of the Act). We also propose to amend Sec.
438.400(c) to clarify that these Medicaid changes apply to applicable
integrated plans no later than January 1, 2021, but, consistent with
our discussion earlier on the effective dates of this rule overall, we
would not preclude states from applying them sooner.
In Sec. 438.402, we propose amending paragraph (a) to
allow a Medicaid managed care plan operating as part of an applicable
integrated plan to the grievance and appeal requirements laid out in
Sec. Sec. 422.629 through 422.634 in lieu of the normally applicable
Medicaid managed care requirements.
3. Proposal for Prescription Drug Plan Sponsors' Access to Medicare
Parts A and B Claims Data Extracts (Sec. 423.153)
a. Background
This proposed rule sets forth the manner in which CMS proposes to
implement section 50354 of the Bipartisan Budget Act of 2018 (BBA),
Public Law 115-123, enacted on February 9, 2018. Section 50354 amends
section 1860D-4(c) of the Social Security Act by adding a new paragraph
(6) entitled ``Providing Prescription Drug Plans with Parts A and B
Claims Data to Promote the Appropriate Use of Medications and Improve
Health Outcomes''. Specifically, section 1860D-4(c)(6)(A), as added by
section 50354 of the BBA, provides that the Secretary shall establish a
process under which the sponsor of a Prescription Drug Plan (PDP) that
provides prescription drug benefits under Medicare Part D may request,
beginning in plan year 2020, that the Secretary provide on a periodic
basis and in an electronic format standardized extracts of Medicare
claims data about its plan
[[Page 55016]]
enrollees. Such extracts would contain a subset of Medicare Parts A and
B claims data as determined by the Secretary. In defining the specific
data elements and time frames for the Parts A and B claims data
included in such extracts, hereinafter referred to as ``Medicare claims
data,'' the Secretary is instructed, at section 1860D-(4)(c)(6)(D) of
the Social Security Act, to include data ``as current as practicable.''
Section 1860D-4(c)(6)(B), as added by section 50354 of the BBA,
further specifies that PDP sponsors receiving such Medicare claims data
for their corresponding PDP plan enrollees may use the data for: (i)
Optimizing therapeutic outcomes through improved medication use; (ii)
improving care coordination so as to prevent adverse healthcare
outcomes, such as preventable emergency department visits and hospital
readmissions; and (iii) for any other purposes determined appropriate
by the Secretary. Finally, section 1860D-4(c)(6)(C) states that the PDP
sponsor may not use the data: (i) To inform coverage determinations
under Part D; (ii) to conduct retroactive reviews of medically accepted
conditions; (iii) to facilitate enrollment changes to a different PDP
or a MA-PD plan offered by the same parent organization; (iv) to inform
marketing of benefits; and (v) for any other purpose the Secretary
determines is necessary to include in order to protect the identity of
individuals entitled to or enrolled in Medicare, and to protect the
security of personal health information.
b. Provisions of the Proposed Rule
To implement the new statutory provision at section 1860D-4(c)(6),
as added by section 50354 of the BBA, we propose to add a new paragraph
(g) at Sec. 423.153. Throughout this discussion of our proposed
approach, we identify options and alternatives to the policies we
propose. We strongly encourage comments on our proposed approach, as
well as any alternatives.
c. Purposes and Limitations on the Use of Data
Section 1860D-4(c)(6)(B) of the Act expressly permits the use of
Medicare claims data for two specified purposes: (1) To optimize
therapeutic outcomes through improved medication use and (2) to improve
care coordination so as to prevent adverse health outcomes. In
addition, section 1860D-4(c)(6)(B)(iii) provides that the Secretary can
determine if there are other appropriate purposes for which the data
may be used.
Therefore, consistent with the statute, we propose at Sec.
423.153(g)(3), that PDP sponsors would be permitted to use Medicare
claims data to optimize therapeutic outcomes through improved
medication use, and to improve care coordination so as to prevent
adverse health outcomes. In addition, we propose to permit PDP sponsors
to use Medicare claims data for the purposes described in the first or
second paragraph of ``health care operations'' under 45 CFR 164.501, or
that qualify as ``fraud and abuse detection or compliance activities''
under 45 CFR 164.506(c)(4). We also propose to permit disclosures that
qualify as a ``required by law'' disclosure as defined at 45 CFR
164.103. We believe these uses should encompass the full range of
activities for which the PDP sponsors will need Medicare claims data.
However, we request comments on whether there are any additional
purposes for which PDP sponsors should be permitted to use Medicare
claims data provided under this subsection.
Section 1860D-4(c)(6)(C) of the Act places specific limitations on
how Medicare claims data provided to the PDP sponsors may be used and
also permits the Secretary to determine if any additional limitations
should be imposed to protect the identity of individuals entitled to,
or enrolled for, benefits under Medicare and to protect the security of
personal health information. Therefore, consistent with these statutory
limitations, at Sec. 423.153(g)(4), we propose that PDP sponsors must
not use Medicare claims data provided by CMS under this subsection for
any of the following purposes: (i) To inform coverage determinations
under Part D; (ii) To conduct retroactive reviews of medically accepted
indications determinations; (iii) To facilitate enrollment changes to a
different prescription drug plan or an MA-PD plan offered by the same
parent organization; and/or (iv) to inform marketing of benefits.
Section 1860D-4(c)(6)(C)(v) of the Act provides that the Secretary
may place additional limitations on the use of Medicare claims data as
necessary to protect the identity of individuals entitled to, or
enrolled for, benefits under Part D, and to protect the security of
personal health information. CMS is committed to ensuring beneficiary-
level data is protected by strict privacy and security requirements.
Therefore, at Sec. 423.153(g)(4)(v), we also propose to require that
the PDP sponsor contractually bind its Contractors that it anticipates
giving access to Medicare claims data, and any other potential
downstream data recipients, to the terms and conditions imposed on the
PDP Sponsor under the proposed provision at Sec. 423.153(g). In
addition, we propose at Sec. 423.153(g)(4)(vi) that CMS may refuse to
make future releases of Medicare claims data to the PDP sponsor if it
makes a determination or has a reasonable belief that unauthorized
uses, reuses, or disclosures have taken place.
We believe that PDP sponsors are business associates receiving
Medicare claims data on behalf of the PDP, a health plan and HIPAA
covered entity. We also believe that Medicare claims data provided to
PDP sponsors under Sec. 423.153(g) is protected health information
(PHI). As a business associate, the PDP sponsor is required to comply
with the HIPAA Rules, including Privacy, Security and Breach
Notification requirements for PHI. Therefore, we do not propose any
additional limitations on the PDP sponsors' use of the Medicare claims
data. However, we request comments on whether there are any additional
limitations that should be placed on Medicare claims data provided
under Sec. 423.153(g). To ensure that the PDP sponsors understand the
purposes for which the Medicare claims data may be used and the
limitations on its use, we propose at Sec. 423.153(g)(5)) to require
that, as a condition of receiving the requested data, the PDP sponsor
must attest that it will adhere to the permitted uses and limitations
on the use of the Medicare claims data in paragraphs (3) and (4) of
Sec. 423.153(g). We propose to require this attestation as a means of
ensuring an understanding of, and compliance with, the terms and
conditions of data access. We believe that our proposal to require PDP
sponsors to attest that they will comply with these requirements is
necessary to ensure the protection of the identities of Medicare
beneficiaries and the security of the Medicare claims data. We request
comments on our proposal to require PDP sponsors to submit an
attestation and on the specific requirements that should be included in
that attestation.
d. Data Request
Section 1860D-4(c)(6)(A) of the Act provides that the Secretary
shall establish a process under which a PDP sponsor of a prescription
drug plan may submit a request for the Secretary to provide the sponsor
with standardized extracts of Medicare claims data for its enrollees.
Therefore, we propose at Sec. 423.153(g)(1) to establish a process by
which a PDP sponsor may submit a request to CMS to receive standardized
extracts of Medicare claims data for its enrollees. We propose to
accept data requests on an ongoing basis beginning
[[Page 55017]]
January 1, 2020. We propose to require that such data requests must be
submitted in a form and manner specified by CMS. Consistent with the
discretion accorded to the Secretary under section 1860D-4(c)(6)(D) of
the Act, we propose not to allow PDP sponsors to request data for
subsets of their enrolled beneficiary populations. We propose allowing
requests to be submitted without an end date, such that the request,
once reviewed for completeness and approved, will remain in effect
until one or more of the following occur: The PDP sponsor notifies CMS
that it no longer wants to receive Medicare claims data, CMS cancels
access to Medicare claims data when a PDP sponsor leaves the Part D
program, or CMS concludes or has a reasonable belief, at its sole
discretion, that the PDP sponsor has used, reused or disclosed the
Medicare claims data in a manner that violates the requirements of
section 1860D-4(c)(6) and Sec. 425.153(g) of the Act. Upon receipt of
the request from the PDP sponsor and the PDP's execution of an
attestation discussed earlier, and review for completeness and approval
of the application by CMS or its contractor, we propose that the PDP
sponsor would be provided access to Medicare claims data. We note that
access to Medicare claims data will be further subject to all other
applicable laws, including, but not limited to, the part 2 regulations
governing access to certain substance abuse records (42 CFR part 2).
d. Data Extract Content
To develop a proposed data set to include in the standardized
extracts of Medicare claims data, we first considered what Medicare
claims data PDP sponsors might require if they were to undertake the
activities expressly permitted by section 1860D-4(c)(6)(B) of the Act.
In doing so, we attempted to limit the data set to the minimum data
that we believe PDP sponsors would need to carry out those statutory
activities and the additional activities we are proposing to permit
under Sec. 423.153(g)(3). That is, we sought to establish data access
limits that would comport with the HIPAA Privacy Rule's minimum
necessary concept at 45 CFR 164.502(b) and 164.514(d), and CMS' policy-
driven data release policies.
We believe that data from all seven claim types, including
inpatient, outpatient, carrier, durable medical equipment, hospice,
home health, and skilled nursing facility data, would be required to
carry out the permitted uses of the data under section 1860D-4(c)(6)(B)
and the proposed provision at Sec. 423.153(g)(3). We believe that
information on all Parts A and B services provided to a patient, as
well as the dates on which those services were furnished, would provide
a more complete picture of a patient's health care services and support
care coordination and quality improvement activities. In addition, this
claims information would provide insight into the services or
procedures that resulted in a patient receiving a certain prescription
drug, and the particular care setting in which the drug was prescribed,
which will assist PDP sponsors in promoting the appropriate use of
medication and improving health outcomes for their enrollees.
We also considered the types of data elements that other entities
request when they ask for data to conduct care coordination and quality
improvement work. For example, we looked at the data elements requested
by entities participating in the CMS Oncology Care Model (OCM). OCM
aims to provide higher quality, more highly coordinated oncology care
at the same or lower cost to Medicare. Because Section 1860D-4(c)(6)
focuses on providing Medicare claims data to promote the appropriate
use of medications and improve health outcomes, we propose to initially
include the following Medicare Parts A and B claims data elements
(fields) in the standardized extract: An enrollee identifier, diagnosis
and procedure codes (for example, ICD-10 diagnosis and Healthcare
Common Procedure Coding System (HCPCS) codes); dates of service; place
of service; provider numbers (for example, NPI); and claim processing
and linking identifiers/codes (for example, claim ID, and claim type
code). CMS will continue to evaluate the data elements provided to PDP
sponsors to determine if data elements should be added or removed based
on the information needed to carry out the permitted uses of the data.
In making decisions about adding data elements to the standardized
extracts, CMS will consider whether the additional data elements
support the purposes for which the data can be used. Any proposed
changes would be established through rulemaking.
We next considered the beneficiary population for which we should
draw the identified data elements, and what time span of data would
best serve PDP sponsors while honoring the requirement at section
1860D-4(c)(6)(D) of the Act that the data should be as current as
practicable. Taking into account the purpose for which Medicare claims
data is being provided, namely to support the appropriate use of
medications and improve health outcomes, we believe that only the most
current data is relevant. Therefore, because only the most timely data
is needed for care coordination purposes, we propose at Sec.
423.153(g)(2) to draw the standardized extracts of Medicare claims data
for items and services furnished under Medicare Parts A and B to
beneficiaries who are enrolled in a Part D plan offered by the Part D
sponsor at the time of the disclosure. We anticipate that Medicare
claims data would be provided at least quarterly with approximately a 3
month lag from the last day of the last month of the prior quarter. In
addition, we anticipate it can take up to two months to process and
ship the data extracts from the date the quarterly data is available.
Therefore, we propose that the first standardized data extract would be
available to PDP sponsors no earlier than August 15, 2020, which would
include, at a minimum, data for the period beginning January 1, 2020,
and ending on March 1, 2020. In addition, given the permitted uses of
the data, we propose to use a standard format to deliver the resulting
data to each PDP sponsor with standard format extracts, meaning that
CMS would not customize the extracts for a PDP sponsor. We propose to
make these standardized data extracts available to eligible PDP
sponsors at least quarterly, as described earlier, but only on a
specified release date that would be applicable to all eligible PDP
Sponsors. That is, we propose that newly eligible PDP sponsors would
not have an opportunity to request standardized data extracts generated
retroactively after the passing of the release date for a given
release. Therefore, if a PDP sponsor submits a request, is approved to
receive data, and executes its attestation after the release of a set
of data extracts (for example, after the release date for Quarter 1
2020), we anticipate that the newly eligible PDP Sponsor would not
receive data until the next standardized data extract is available (for
example, the release date for Quarter 2 of 2020).
We believe that these standardized data extracts would provide PDP
sponsors with the minimum data necessary to carry out the permitted
uses specified in section 1860D-4(c)(6)(B) of the Act and as proposed
at Sec. 423.153(g)(3). We seek comments about the proposed frequency
and contents of the standardized data extracts.
[[Page 55018]]
B. Improving Program Quality and Accessibility
1. Medicare Advantage and Part D Prescription Drug Plan Quality Rating
System (Sec. Sec. 422.162(a) and 423.182(a), Sec. Sec. 422.166(a) and
423.186(a), Sec. Sec. 422.164 and 423.184, and Sec. Sec.
422.166(i)(1) and 423.186(i)(1))
a. Introduction
Earlier this year, in the April 2018 final rule, CMS codified at
Sec. Sec. 422.160, 422.162, 422.164, and 422.166 (83 FR 16725 through
83 FR 16731) and Sec. Sec. 423.180, 423.182, 423.184, and 423.186 (83
FR 16743 through 83 FR 16749) the methodology for the Star Ratings
system for the MA and Part D programs, respectively. This was part of
the Administration's effort to increase transparency and advance notice
regarding enhancements to the Part C and D Star Ratings program. Going
forward CMS must propose through rulemaking any changes to the
methodology for calculating the ratings, the addition of new measures,
and substantive measure changes. The April 2018 final rule included
mechanisms for the removal of measures for specific reasons (low
statistical reliability and when the clinical guidelines associated
with the specifications of measures change such that the specifications
are no longer believed to align with positive health outcomes) but,
generally, removal of a measure for other reasons would also occur
through rulemaking.
Commenters to last year's Notice of Proposed Rulemaking (NPRM)
expressed overall support for the use of the hierarchical clustering
algorithm which is the methodology used for determining the non-
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
measure-specific cut points. The cut points are used to separate a
measure-specific distribution of scores into distinct, non-overlapping
groups, or star categories. However, the majority of commenters also
recommended some enhancements be made to the proposed clustering
methodology to capture the attributes that they consider important.
Commenters expressed a strong preference for cut points that are
stable, predictable, and free from undue influence of outliers.
Further, some commenters expressed a preference for caps to limit the
amount of movement in cut points from year to year. CMS did not
finalize any changes in last year's rule to the clustering algorithm
for the determination of the non-CAHPS cut points for the conversion of
measure scores to measure-level Star Ratings to allow the necessary
time to simulate and examine the feasibility and impact of the
suggestions provided in response to the proposed rule. In addition, CMS
evaluated the degree to which the simulations captured the desired
attributes identified by the commenters.
At this time, we are proposing enhancements to the cut point
methodology for non-CAHPS measures. We are also proposing substantive
updates to the specifications for 2 measures for the 2022 Star Ratings
and substantive updates to the specifications for 1 measure for the
2023 Star Ratings. We are also proposing rules for calculating Star
Ratings in the case of extreme and uncontrollable circumstances. Unless
otherwise stated, data would be collected and performance would be
measured as described in these proposed rules and regulations for the
2020 measurement period; the associated quality Star Ratings would be
released prior to the annual election period held in late 2021 for the
2022 contract year and would be used to assign Quality Bonus Payment
ratings for the 2023 payment year. Because of the timing of the release
and use in conjunction with the annual coordinated election period,
these would be the ``2022 Star Ratings.''
b. Definitions
We propose to add the following definitions for the respective
subparts in part 422 and part 423, in paragraph (a) of Sec. Sec.
422.162 and 423.182, respectively. These proposed new definitions are
relevant for our proposed policies and are used in that context.
Absolute percentage cap is a cap applied to non-CAHPS
measures that are on a 0 to 100 scale that restricts movement of the
current year's measure-threshold-specific cut point to no more than the
stated percentage as compared to the prior year's cut point.
Cut point cap is a restriction on the change in the amount
of movement a measure-threshold-specific cut point can make as compared
to the prior year's measure-threshold-specific cut point. A cut point
cap can restrict upward movement, downward movement, or both.
Guardrail is a bidirectional cap that restricts both
upward and downward movement of a measure-threshold-specific cut point
for the current year's measure-level Star Ratings as compared to the
prior year's measure-threshold-specific cut point.
Mean resampling refers to a technique where measure-
specific scores for the current year's Star Ratings are randomly
separated into 10 equal-sized groups. The hierarchical clustering
algorithm is done 10 times, each time leaving one of the 10 groups out.
The method results in 10 sets of measure-specific cut points. The mean
cut point for each threshold per measure is calculated using the 10
values.
By leaving out one of the 10 groups for each run, 9 of the 10
groups which is 90 percent of the applicable measure scores are used
for each run of the clustering algorithm.
Restricted range is the difference between the maximum and
minimum measure score values using the prior year measure scores
excluding outer fence outliers (first quartile -3 * Interquartile Range
(IQR) and third quartile + 3 * IQR).\19\
---------------------------------------------------------------------------
\19\ The first quartile is median of the lower half of the data,
or in other words the value in the data once arranged in numerical
order that divides the lower half into two equal parts. The third
quartile is the median of the upper half of the data.
---------------------------------------------------------------------------
We propose to specify in the definition the criteria used to
identify the values that correspond to the outer fences which are used
to identify extreme outliers in the data. Outer fence outliers use
established statistical criteria for the determination of the boundary
values that correspond to the outer fences. The outer fences are the
boundary values for an outer fence outlier such that any measure score
that either exceeds the value of the upper outer fence (third quartile
+ 3*IQR) or that is less than the lower outer fence (first quartile -3
* IQR) is classified as an outer fence outlier and excluded from the
determination of the value of the restricted range cap.
Restricted range cap is a cap applied to non-CAHPS
measures that restricts movement of the current year's measure-
threshold-specific cut point to no more than the stated percentage of
the restricted range of a measure calculated using the prior year's
measure score distribution.
We welcome comments on these definitions.
c. Measure-Level Star Ratings (Sec. Sec. 422.166(a), 423.186(a))
At Sec. Sec. 422.166(a) and 423.186(a) we codified the methodology
for calculating Star Ratings at the measure level. The methodology for
non-CAHPS measures employs a hierarchical clustering algorithm to
identify the gaps that exist within the distribution of the measure-
specific scores to create groups (clusters) that are then used to
identify the cut points. The Star Ratings categories are designed such
that the scores in the same Star Ratings category are as similar as
possible and the scores in different Star Ratings categories are as
different as possible. The current methodology uses only data that
[[Page 55019]]
correspond to the measurement period of the data used for the current
Star Ratings program. The cut points, as implemented now, are
responsive to changes in performances from one year to the next.
Changes in the measure-level specific cut points across a Star Ratings
year reflect lower or higher measure performance than the prior year,
as well as shifts in the distribution of the scores.
In the April 2018 final rule, CMS detailed the goals of the Star
Ratings program. The overarching goals of the Star Ratings program and
the specific sub-goals of setting cut points serve as the rationale for
any proposed changes.
The Star Ratings display quality information on Medicare Plan
Finder to help beneficiaries, families, and caregivers make informed
choices by being able to consider a plan's quality, cost, and coverage;
to provide information for public accountability; to incentivize
quality improvement; to provide information to oversee and monitor
quality; and to accurately measure and calculate scores and stars to
reflect true performance. In addition, pursuant to section 1853(o) of
the Act and the Medicare Program; Changes to the Medicare Advantage and
the Medicare Prescription Drug Benefit Programs for Contract Year 2012
and Other Changes Final Rule (76 FR 21485 through 21489), the Star
Ratings are also used to assign Quality Bonus Payments as provided in
Sec. 422.558(d).
To separate a distribution of measure scores into distinct groups
or star categories, a set of values must be identified to separate one
group from another group. The set of values that break the distribution
of the scores into non-overlapping groups is referred to as a set of
cut points. The primary goal of any cut point methodology is to
disaggregate the distribution of scores into discrete categories such
that each grouping accurately reflects true performance.
The current MA Star Ratings methodology converts measure-specific
scores to measure-level Star Ratings so as to categorize the most
similar scores within the same measure-level Star Rating while
maximizing the differences across measure-level Star Ratings. To best
serve their purpose, the Star Ratings categories must capture
meaningful differences in quality across the Star Ratings scale and
minimize the risk of misclassification. For example, it would be
considered a misclassification if a ``true'' 4-star contract were
scored as a 3-star contract, or vice versa, or if nearly-identical
contracts in different measure-level star categories were mistakenly
identified. CMS currently employs hierarchical clustering to identify
the cut points for non-CAHPS measures to ensure that the measure-level
Star Ratings accurately reflect true performance and provide a signal
of quality and performance on Medicare Plan Finder to empower
beneficiaries, families, and caregivers to make informed choices about
plans that would best align with their priorities.
We solicited comments regarding the approach to convert non-CAHPS
measure scores to measure-level Star Ratings (82 FR 56397 through
56399). We requested stakeholders to provide input on the desirable
attributes of cut points and recommendations to achieve the suggested
characteristics. In addition, we requested that commenters either
suggest alternative cut point methodologies or provide feedback on
several options detailed in the regulation such as setting the cut
points by using a moving average, using the mean of the 2 or 3 most
recent years of data, or restricting the size of the change in the cut
points from 1 year to the next.
The commenters identified several desirable attributes for the cut
points that included stability, predictability, attenuation of the
influence of outliers, restricted movement of the cut points from 1
year to the next, and either pre-announced cut points before the plan
preview period or pre-determined cut points before the start of the
measurement period. In the April 2018 final rule (83 FR 16567), we
expressed appreciation for our stakeholders' feedback and stated our
intent to use it to guide the development of an enhanced methodology.
So as not to implement a methodology that may inordinately increase the
risk of misclassification, CMS has analyzed and simulated alternative
options to assess the impact of any enhancements on the Star Ratings
program and assess the degree to which the alternative methodology
captures the desirable attributes that were identified by stakeholders.
While CMS balances the request of stakeholders to increase
predictability and stability of the cut points from year to year, the
goals of the Star Ratings program, the integrity of the methodology,
and the intent of the cut point methodology remain the same. The intent
of the cut point methodology is still to accurately measure true
performance. We intend our proposal to serve these goals and solicit
comment on whether we have met our objective in this respect.
A Technical Expert Panel (TEP), comprised of representatives across
various stakeholder groups, convened on May 31, 2018 to provide
feedback to CMS's Star Ratings contractor (currently RAND Corporation)
on the Star Ratings framework, topic areas, methodology, and
operational measures. Information about the current members of the TEP
can be found at https://www.rand.org/content/dam/rand/pubs/conf_proceedings/CF300/CF391/RAND_CF391.members.pdf. One topic
discussed was possible enhancements to the clustering methodology used
to convert non-CAHPS measure scores to measure-level Star Ratings. The
TEP provided input on the importance of the cut point attributes of
predictability and stability. To increase the level of predictability,
several TEP members discussed the use of caps. Further, the TEP
suggested that the influence of outliers should be addressed in the
methodology. While some TEP members spoke to the utility of pre-
announced thresholds to allow contracts to make decisions, other TEP
members stated that there are real risks in doing so. After reviewing
the data that would need to be employed for pre-announced cut points
along with the measure score and cut point trends, TEP members were
concerned about using older data to predict cut points. For example,
high performers may stop their focus on particular measures if they
knew in advance that they would receive a 5-star rating. Likewise,
contracts whose measure performance would not reach high Star Ratings
may stop working on achieving a goal perceived to be unattainable. Some
of the TEP members requested that CMS, in addition to addressing
outliers, establish guardrails so cut points do not fluctuate too much
from year to year. Additional information about the TEP can be found at
http://www.rand.org/star-ratings-analyses.
CMS has examined numerous alternative methodologies to minimize the
influence of outliers, to restrict the upward or downward movement of
cut points from one year to the next, and to simulate prediction models
to allow either limited advance notice or full advance notice of cut
points prior to the measurement period. As part of our analyses, we
have analyzed trends in performance across the Star Ratings measures.
The ability to announce cut points before (full advance notice) or
during (partial advance notice) the measurement period requires the use
of modeling and older data to project the cut points, as well as the
need for an alternative methodology for new measures introduced to the
Star Ratings program. Modeling is challenging given differences in the
performance trends over time across the Star Ratings measures, thus a
single approach for
[[Page 55020]]
predicting all future performance does not accurately reflect
performance for all measures.
Using prediction models to establish future cut points may have
unintended consequences and misalign with the underlying goals of the
Star Ratings program and sub-goals of setting cut points. Predicting
future cut points using older data can lead to both over or under-
estimations of performance which results in a distorted signal of the
Star Ratings. Over projections in the cut points will result in higher
cut points and lower measure-level Star Ratings. Conversely, under
projections can lead to lower cut points and higher measure-level Star
Ratings. The risk of misclassification is heightened when the accuracy
of the projected cut points is diminished. The use of older data for
setting cut points does not allow the Star Ratings to be responsive to
changes in performance in the current year. Furthermore, setting cut
points in advance of the measurement year may lead to MA organizations
and Part D sponsors not focusing on certain areas once they achieve a
set threshold, eliminating incentives for improvement.
For example, CMS provided incentives for eligible providers to
adopt certified Electronic Health Records (EHRs) and report quality
measures under the Meaningful Use (MU) initiative. There were large
gains in performance for a subset of Star Ratings measures that were
enabled through the EHR, a structural change among health care
providers in the delivery of care. Further, an examination of
performance over time of EHR-enabled measures indicates a decrease in
variability of measure scores with contract performance converging
toward greater uniformity. Modeling future performance using past
performance would fail to capture the large gains in performance in the
EHR-enabled measures, which would have resulted in cut points that were
artificially low and measure-level Star Ratings that were higher than
true performance.
Pre-announced cut points for other subsets of measures in the Star
Ratings would present different challenges as compared to EHR-enabled
measures. Performance on new measures typically has more room to
improve, and large year-to-year gains are possible and desirable from a
quality improvement perspective. Projecting cut points using older data
from periods of rapid improvement would artificially inflate future cut
points which would cause artificially low measure-level Star Ratings.
Measures that demonstrate very slow, consistent growth over time could
have projected cut points that are artificially high. The further the
projection is in advance of the measurement period, the larger the
potential for unintended consequences. In addition, there exists the
possibility of external factors, other than structural, that are
unanticipated and unforeseen that could impact the distribution of
scores for which modeling would not capture.
Some of the challenges of full or partial advance notice include
all of the following:
Older data often do not accurately reflect current
performance.
The trend in average performance is not always linear.
External or structural factors may occur that can lead to
substantial changes from period to period rather than steady slow year-
over-year improvement.
Larger gains in performance year to year exist for
relatively new measures, compared to more established measures.
The rate of change is less likely to be linear at lower
threshold levels where contracts have greater opportunities for
improvement.
Decreasing variation in measure scores reflects greater
improvements in performance for lower versus higher-performing
contracts--contract performance is converging over time toward greater
uniformity.
These challenges are critical to consider because if we modify the
current methodology to predict (or set) cut points using older data and
a single model across all measures, we risk causing unintended
consequences such as significantly diminishing incentives for
improvement or having the Star Ratings misaligned with changes in
performance that may be due to external or structural factors.
Based on stakeholder feedback and analyses of the data, we propose
two enhancements to the current hierarchical clustering methodology
that is used to set cut points for non-CAHPS measure stars in
Sec. Sec. 422.166(a)(2)(i) and 423.186(a)(2)(i). The first proposed
enhancement is mean resampling. With mean resampling, measure-specific
scores for the current year's Star Ratings are randomly separated into
10 equal-sized groups. The hierarchical clustering algorithm is done 10
times, each time leaving one of the 10 groups out. The method results
in 10 sets of measure-specific cut points. The mean cut point for each
threshold per measure is calculated using the 10 values. Mean
resampling reduces the sensitivity of the clustering algorithm to
outliers and reduces the random variation that contributes to
fluctuations in cut points and, therefore, improves the stability of
the cut points over time. Mean resampling uses the most recent year's
data for the determination of the cut points; thus, it does not require
assumptions for predicting cut points over time and it continues to
provide incentives for improvement in measure scores. The drawback of
mean resampling alone is that it does not restrict the movement of the
cut points, so the attribute of predictability is not fully captured
with this methodology.
To increase the predictability of the cut points, we also propose a
second enhancement to the clustering algorithm: A guardrail for
measures that have been in the Part C and D Star Ratings program for
more than 3 years. The proposed guardrail of 5 percent would be a bi-
directional cap that restricts movement both above and below the prior
year's cut points. A 5 percent cap restricts the movement of a cut
point by imposing a rule for the maximum allowable movement per measure
threshold; thus, it allows a degree of predictability. The trade-off
for the predictability provided by bi-directional caps is the inability
to fully keep pace with changes in performance across the industry.
While cut points that change less than the cap would be unbiased and
keep pace with changes in the measure score trends, changes in overall
performance that are greater than the cap would not be reflected in the
new cut points. A cap on upward movement may inflate the measure-level
Star Ratings if true gains in performance improvements cannot be fully
incorporated in the current year's ratings. Conversely, a cap on
downward movement may decrease the measure-level Star Ratings since the
ratings would not be adjusted fully for downward shifts in performance.
A measure-threshold-specific cap can be set multiple ways and the
methodology may differ based on whether the measure is scored on a 0 to
100 scale or an alternative scale. For measures on a 0 to 100 scale,
the cap can restrict the movement of the measure cut points from one
year to the next by a fixed percentage, such as an absolute 5
percentage point cap. For measures not on a 0 to 100 scale, the cap can
be determined for each measure by using a percentage of the measure's
score distribution or a subset of the distribution, such as 5 percent
of the range of the prior year scores without outer fence outliers,
referred to as a restricted range cap. Alternatively, a restricted
range cap can be used for all measures, regardless of scale, using a
cap based on the range of the prior year scores without outliers. We
propose an absolute 5 percentage point cap for all
[[Page 55021]]
measures scored on a 0 to 100 scale and 5 percent of the restricted
range for all measures not on a 0 to 100 scale, but we are also
considering alternatives to the 5 percent cap, such as using 3 percent;
we believe that any cap larger than 5 percent would not provide the
predictability requested by stakeholders that we are trying to
incorporate. While smaller caps provide more predictability, it is more
likely that the cut points will not keep pace with changes in measure
scores in the industry as the cap size gets smaller, and may require
future larger one-time adjustments to reset the measure cut points.
Therefore, we are not sure that a smaller cap, even at a 3 percent
threshold, would meet our programmatic needs and goals of providing
accurate pictures of the underlying performance of each contract and
its comparison to other contracts. We are proposing 5 percent because
the use of the cap allows predictability of the cut points from year to
year, but also balances the desire to continue to create incentives for
contracts to focus on the quality of care of their enrollees and strive
to improve performance. If the cut points are not keeping pace with the
changes in the scores over time, CMS may need to propose in the future
how to periodically adjust the cut points to account for significant
changes in industry performance.
In summary, we propose to modify Sec. Sec. 422.166(a)(2)(i) and
423.186(a)(2)(i) to add mean resampling to the current clustering
algorithm to attenuate the effect of outliers, and measure-specific
caps in both directions to provide guardrails so that the measure-
threshold-specific cut points do not increase or decrease more than the
cap from one year to the next. We propose a 5 percentage point absolute
cap for measures on a 0 to 100 scale and a 5 percent restricted range
cap ((0.05) * (maximum value-minimum value), where the maximum and
minimum values are calculated using the prior year's measure score
distributions excluding outer fence outliers). For any new measures
that have been in the Part C and D Star Rating program for 3 years or
less, we propose to use the hierarchal clustering methodology with mean
resampling for the first 3 years in the program in order to not cap the
initial increases in performance that are seen for new measures. We
welcome comments on this proposal, including comments on the percentage
used for the cap, whether the cap should be an absolute percentage
difference for measures on a 0 to 100 scale, whether the cap should be
a percent of the range of prior year scores without outliers for all
measures or for the subset of measures not on a 0 to 100 scale, whether
the cap should be in both the upward and downward directions, and
alternative methods to account for outliers.
d. Updating Measures (Sec. Sec. 422.164, 423.184)
In the April 2018 final rule (83 FR 16537), CMS stated that due to
the regular updates and revisions made to measures, CMS would not
codify a list of measures and specifications in regulation text; CMS
adopted a final list of measures for the contract year 2019 measurement
period and indicated how changes to that list--additions, updates,
removals--would be done in the future, using the Advance Notice and
Rate Announcement under section 1853(b) of the Act or rulemaking. The
regulations at Sec. Sec. 422.164 and 423.184 specify the criteria and
procedure for adding, updating, and removing measures for the Star
Ratings program. CMS lists the measures used for the Star Ratings each
year in the Technical Notes or similar guidance document with
publication of the Star Ratings. In this rule, CMS is proposing measure
changes to the Star Ratings program for performance periods beginning
on or after January 1, 2020 and performance periods beginning on or
after January 1, 2021. For new measures and substantive updates to
existing measures, as described at Sec. Sec. 422.164(c) and (d)(2),
and Sec. Sec. 423.184(c) and (d)(2), CMS will initially announce and
solicit comment through the process described for changes in and
adoption of payment and risk adjustment policies in section 1853(b) of
the Act and subsequently propose these measures through rulemaking to
be added to the Star Ratings program. Proposals here for substantive
updates have been discussed in prior Call Letters (contract years 2018
and 2019). We will continue the process of announcing our intent with
regard to measure updates in future Call Letters. Any measures with
substantive updates must be on the display page for at least 2 years
before use in the Star Ratings program. For new measures and measures
with substantive updates, as described at Sec. Sec. 422.166(e)(2) and
423.186(e)(2), the measure will receive a weight of 1 for the first
year in the Star Ratings program. In the subsequent years, the measure
will be assigned the weight associated with its category.
(1) Proposed Measure Updates
(a) Controlling High Blood Pressure (Part C)
Due to the release of new hypertension treatment guidelines from
the American College of Cardiology and American Heart Association,\20\
NCQA has implemented updates to the Controlling High Blood Pressure
measure for HEDIS 2019. NCQA has revised the blood pressure target to
<140/90 mmHg. NCQA has also made some structural changes to the measure
that included allowing two outpatient encounters to identify the
denominator and removing the medical record confirmation for
hypertension, allowing the use of telehealth services for one of the
outpatient encounters in the denominator, adding an administrative
approach that utilizes CPT category II codes for the numerator, and
allowing remote monitoring device readings for the numerator. Given the
change to the blood pressure target and our rules for moving measures
with substantive changes to the display page, this measure will be
moved to the display page for the 2020 and 2021 Star Ratings. We
propose to return this measure as a measure with substantive updates by
the measure steward (NCQA) to the 2022 Star Ratings using data from the
2020 measurement year with, as required by Sec. 422.164(d)(2) and
Sec. 422.166(e)(2), a weight of 1 for the first year and a weight of 3
thereafter.
---------------------------------------------------------------------------
\20\ See Whelton P.K., Carey R.M., Aronow W.S., et al. (2018).
Guideline for the prevention, detection, evaluation, and management
of high blood pressure in adults: A report of the American College
of Cardiology/American Heart Association Task Force on Clinical
Practice Guidelines. Journal of the American College of Cardiology.
71(19): e127-e248. Available at http://www.onlinejacc.org/content/71/19/e127?_ga=2.143510773.1362500146.1536262802-126396490.1536262802.
---------------------------------------------------------------------------
(b) MPF Price Accuracy (Part D)
Continued evaluation of sponsors' pricing data used by
beneficiaries is important; therefore, we propose to make enhancements
to the MPF Price Accuracy measure to better measure the reliability of
a contract's MPF advertised prices. In accordance with Sec.
423.184(d)(2), the substantively updated measure would be a display
measure for 2020 and 2021 and we are proposing to use it in the 2022
Star Ratings in place of the existing MPF Price Accuracy measure, which
will remain in the Star Ratings until that replacement under Sec.
423.184(d)(2). The proposed update would measure the magnitude of
difference, as well as the frequency of price differences. We propose
to implement the following changes for this measure:
[[Page 55022]]
Factor both how much and how often prescription drug event
(PDE) prices exceeded the prices reflected on the MPF by calculating a
contract's measure score as the mean of the contract's Price Accuracy
and Claim Percentage scores, based on the indexes in this rule:
++ The Price Accuracy index compares point-of-sale PDE prices to
plan-reported MPF prices and determines the magnitude of differences
found. Using each PDE's date of service, the price displayed on MPF is
compared to the PDE price. The Price Accuracy index is computed as:
(Total amount that PDE is higher than MPF + Total PDE cost)/(Total PDE
cost)
++ The Claim Percentage index measures the percentage of all PDEs
that meet the inclusion criteria with a total PDE cost higher than
total MPF cost to determine the frequency of differences found. The
Claim Percentage index is computed as:
(Total number of claims where PDE is higher than MPF)/(Total number of
claims)
++ The best possible Price Accuracy index is 1 and the best
possible Claim Percentage index is 0. This indicates that a plan did
not have PDE prices greater than MPF prices.
++ A contract's measure score is computed as:
--Price Accuracy Score = 100 - ((Price Accuracy Index - 1) * 100)
--Claim Percentage Score = (1 - Claim Percentage Index) * 100
--Measure Score = (0.5 * Price Accuracy Score) + (0.5 * Claim
Percentage Score)
Increase the claims included in the measure:
++ Expand the days' supply of claims included from 30 days to
include claims with fills of 28-34, 60-62, or 90-100 days.
++ Identify additional retail claims using the PDE-reported
Pharmacy Service Type code. Claims for pharmacies that are listed as
retail in the MPF Pharmacy Cost file and also have a pharmacy service
type on the PDE of either Community/Retail or Managed Care Organization
(MCO) will be included.
Round a drug's MPF cost to 2 decimal places for comparison
to its PDE cost. Post-rounding, the PDE cost must exceed the MPF cost
by at least one cent ($0.01) in order to be counted towards the
accuracy score (previously, a PDE cost which exceeded the MPF cost by
$0.005 was counted). A contract may submit an MPF unit cost up to 5
digits, but PDE cost is always specified to 2 decimal places.
Under our proposed update, PDEs priced lower than the MPF display
pricing will continue to be ignored and will not have an impact on the
measure score or rating. Only price increases are counted in the
numerator for this measure. We propose to add this updated measure to
the 2022 Star Ratings based on the 2020 measurement year with a weight
of 1.
(3) Plan All-Cause Readmissions (Part C)
NCQA is modifying the Plan All-Cause Readmissions measure for HEDIS
2020 (measurement year 2019). The measure assesses the percentage of
hospital discharges resulting in unplanned readmissions within 30 days
of discharge. The changes made by NCQA are: Adding observation stays as
hospital discharges and readmissions in the denominator and the
numerator; and removing individuals with high frequency
hospitalizations. These changes were implemented by the measure steward
(NCQA) based on the rise in observation stays to ensure the measure
better reflects patient discharge and readmission volumes. Removing
individuals with high frequency hospitalizations from the measure
calculation allows the readmissions rates not to be skewed by this
population. To date, CMS has only included the 65+ age group in the
Plan All-Cause Readmissions measure. CMS is proposing to combine the
18-64 and 65+ age groups as the updated measure specifications are
adopted and to use NCQA's new recommendation of 150 as the minimum
denominator. Given the substantive nature of the proposed updates for
this measure, it would be moved to display for the 2021 and 2022 Star
Ratings under our proposal and Sec. 422.164(d)(2). We propose to
return this measure as a measure with substantive updates by the
measure steward (NCQA) to the 2023 Star Ratings using data from the
2021 measurement year with, as required by Sec. 422.164(d)(2) and
Sec. 422.166(e)(2), a weight of 1 for the first year and a weight of 3
thereafter.
(4) Improvement Measures (Parts C and D)
The process for identifying eligible measures to be included in the
improvement measure scores is specified as a series of steps at
Sec. Sec. 422.164(f)(1) and 423.184(f)(1). As part of the first step,
the measures eligible to be included in the Part C and D improvement
measures are identified. Only measures that have a numeric score for
each of the 2 years examined are included. We propose to add an
additional rule at Sec. Sec. 422.164(f)(1)(iv) and 423.184(f)(1)(iv)
that would exclude any measure that receives a measure-level Star
Rating reduction for data integrity concerns for either the current or
prior year from the improvement measure(s). The proposed new standard
would ensure that the numeric scores for each of the 2 years are
unbiased. If a measure's measure-level Star Rating receives a reduction
for data integrity concerns in either of the 2 years, the measure would
not be eligible to be included in the improvement measure(s) for that
contract.
Table 1: Proposed Additions and Updates to Individual Star Rating
Measures
The measure descriptions listed in the tables are high-level
summaries. The Star Ratings measure specifications supporting document,
Medicare Part C & D Star Ratings Technical Notes, provides detailed
specifications for each measure. Detailed specifications include, where
appropriate, the identification of a measure's: (1) Numerator, (2)
denominator, (3) calculation, (4) time frame, (5) case-mix adjustment,
and (6) exclusions. The Technical Notes document is updated annually.
In addition, where appropriate, the Data Source descriptions listed in
this table reference the technical manuals of the measure stewards. The
annual Star Ratings are produced in the fall of the prior year to
assist beneficiaries in choosing their health and drug plan during the
annual open enrollment. For example, Star Ratings for the year 2022 are
produced in the fall of 2021.
1. If a measurement period is listed as `the calendar year 2 years
prior to the Star Ratings year' and the Star Ratings year is 2022, the
measurement period is referencing the January 1, 2020 to December 31,
2020 period.
2. For CAHPS, HOS, and HEDIS/HOS measures, the measurement period
is listed as `most recent data submitted for the survey of enrollees.'
See measure stewards' technical manuals, as referenced in Data Source
column, for the specific measurement periods of the most recent data
submitted.
BILLING CODE 4120-01-P
[[Page 55023]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.003
[[Page 55024]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.004
BILLING CODE 4120-01-C
[[Page 55025]]
(5) Data Integrity
At Sec. Sec. 422.164(g)(1)(iii) and 423.184(g)(1)(ii), CMS
codified a policy to make scaled reductions to the Star Ratings for a
contract's Part C or Part D appeals measures because the relevant
Independent Review Entity (IRE) data are not complete based on the
Timeliness Monitoring Project (TMP) or audit information. The reduction
is applied to the measure-level Star Ratings for the applicable appeals
measures. We propose adding an additional regulatory provision at
Sec. Sec. 422.164(g)(1)(iii)(O) and 423.184(g)(1)(ii)(M) that would
assign a 1-star rating to the applicable appeals measure(s) if a
contract fails to submit TMP data for CMS's review to ensure the
completeness of their IRE data. We believe it is appropriate to assume
that there is an issue related to the performance when the MA
organization or Part D plan sponsor has refused to provide information
for the purposes of our oversight of the compliance with the appeals
requirements. Our proposal to modify measure-specific ratings due to
data integrity issues is separate from any CMS compliance or
enforcement actions related to a sponsor's deficiencies; these rating
reductions are necessary to avoid falsely assigning a high star to a
contract, especially when the MA organization or Part D sponsor has
refused to submit data for us to evaluate performance in this area and
to ensure that the data submitted to the IRE are complete.
(6) Review of Sponsors' Data
At Sec. Sec. 422.164(h)(1) and 423.184(h)(1), CMS proposes to
codify a policy regarding the deadlines for an MA organization or Part
D plan sponsor to request CMS or the IRE to review a contract's appeals
or CMS to review a contract's Complaints Tracking Module (CTM) data.
For example, information regarding the Part C and Part D appeals
process is available to MA organizations and is updated daily on the
IRE website. Additionally, sponsors can access the Part D Appeals
Reports under the Performance Metrics pages in HPMS. To allow enough
time for the IRE to make any necessary changes to ensure the accuracy
of a contract's measure score, we are proposing that requests for CMS
or the IRE to review contract data must be received no later than June
30 of the following year in order to have time to use accurate
information in the Star Ratings calculations (for example, changes to
contract year 2018 appeals data must be made by June 30, 2019 for the
2020 Star Ratings). Reopenings are not taken into account under this
proposed deadline for corrections to the IRE data. When the decision is
evaluated for purposes of the appeals measures, if a reopening occurs
and is decided prior to May 1, the revised determination is used in
place of the original reconsidered determination. If the revised
determination occurs on or after May 1, the original reconsidered
determination is used.
Similarly, we propose that any requests for adjustments following
CMS's CTM Standard Operating Procedures for the complaints measures be
made by June 30 of the following year in order for the changes to be
reflected in a contract's Star Ratings data (for example, changes to
contract year 2018 complaints data must be made by June 30, 2019 for
the 2020 Star Ratings).
e. Extreme and Uncontrollable Circumstances
Extreme and uncontrollable circumstances such as natural disasters
can directly affect Medicare beneficiaries and providers, as well as
the Parts C and D organizations that provide them with important
medical care and prescription drug coverage. These circumstances may
negatively affect the underlying operational and clinical systems that
CMS relies on for accurate performance measurement in the Star Ratings
program, all without fault on the part of the MA organization or Part D
plan sponsor. We propose to adjust the Star Ratings to take into
account the effects of extreme and uncontrollable circumstances that
occurred during the performance or measurement period. CMS is also
concerned that certain natural disasters and emergencies may interfere
in plans' abilities to provide services for their enrollees. In this
rule, we describe proposed policies for identifying affected contracts
and adjusting the Star Ratings measures. These policies are largely the
same as those described in the 2019 final Call Letter, with the
substantive exception of eliminating the difference-in-differences
adjustment for survey data. The difference-in-differences adjustment
showed no consistent, negative impact of extreme and uncontrollable
circumstances on the 2019 Star Ratings; therefore, we are eliminating
this adjustment to simplify the methodology for calculating Star
Ratings in cases of extreme and uncontrollable circumstances. We
propose to codify a series of special rules for calculation of the Star
Ratings of certain contracts in certain extreme and uncontrollable
circumstances in paragraph (i) of Sec. Sec. 422.166 and 423.186.
We propose that the adjustments be tailored to the specific areas
experiencing the extreme and uncontrollable circumstance in order to
avoid over-adjustment or adjustments that are unnecessary. Health and
drug plans can serve enrollees across large geographic areas, and thus
they may not be impacted in the same manner as healthcare providers
such as hospitals or medical centers in specific physical locations. To
ensure that the Star Ratings adjustments focus on the specific
geographic areas that experienced the greatest adverse effects from the
extreme and uncontrollable circumstance and are not applied to areas
sustaining little or no adverse effects, our proposal is to target the
adjustments to specific contracts and to further specify and limit the
adjustments.
(1) Identification of Affected Contracts
In paragraph (i)(1) of Sec. Sec. 422.166 and 423.186, we propose
to identify MA and Part D contracts affected by extreme and
uncontrollable circumstances during the performance or measurement
period that may have affected their performance on Star Ratings
measures or their ability to collect the necessary measure-level data.
These ``affected contracts'' would be the contracts eligible for the
adjustments specified in this proposed rule to take into account the
effects of the extreme and uncontrollable circumstances. For an MA or
Part D contract to be considered an affected contract under our
proposal, the contract would need to meet all of the following
criteria:
The contract's service area is within an ``emergency
area'' during an ``emergency period'' as defined in Section 1135(g) of
the Act.
The contract's service area is within a county, parish,
U.S. territory or tribal area designated in a major disaster
declaration under the Stafford Act and the Secretary exercised
authority under section 1135 of the Act based on the same triggering
event(s).
A certain minimum percentage (25 percent for measure star
adjustments or 60 percent for exclusion from cut point and Reward
Factor calculations) of the enrollees under the contract must reside in
a Federal Emergency Management Agency (FEMA)-designated Individual
Assistance area at the time of the extreme and uncontrollable
circumstance.
We propose to identify an area as having experienced extreme and
uncontrollable circumstances if it is within an ``emergency area'' and
``emergency period'' as defined in section 1135(g) of the Act, and also
is
[[Page 55026]]
within a county, parish, U.S. territory or tribal government designated
in a major disaster declaration under the Stafford Act, and the
Secretary exercised authority under section 1135 of the Act based on
the same triggering event(s) (https://www.phe.gov/emergency/news/healthactions/section1135/Pages/default.aspx). Major disaster areas are
identified and can be located on FEMA's website at https://www.fema.gov/disasters. To ensure the policy is applied to those
contracts most likely to have experienced the greatest adverse effects,
we propose to narrow it to apply to contracts with a certain minimum
percentage of enrollees residing in an area declared as an Individual
Assistance area because of the disaster declaration. Individual
Assistance includes assistance to individuals and households, crisis
counseling, disaster case management, disaster unemployment assistance,
disaster legal services, and the disaster Supplemental Nutrition
Assistance Program. We focus on enrollees residing in counties eligible
for Individual Assistance because of a major disaster, because most
Star Ratings measures are based on services provided directly to
beneficiaries in their local area. Health and drug plans can serve
enrollees across large geographic areas, and thus they may not be
impacted in the same manner as healthcare providers such as hospitals
or medical centers in specific physical locations. Therefore, we
believe adjustments to the Star Ratings are most appropriately targeted
to contracts serving beneficiaries who were eligible for individual and
household assistance because of the disaster declaration.
For adjustments, at least 25 percent or 60 percent of the enrollees
under the contract must reside in Individual Assistance areas
identified because of the extreme and uncontrollable circumstances.
This ensures that the adjustments are limited to contracts that we
believe may have experienced a real impact from the extreme and
uncontrollable circumstance in terms of operations or ability to serve
enrollees. In calculations for the 2019 Star Ratings, we observed that
contracts tend to have either very few enrollees impacted or most of
their enrollees impacted due to the nature of contracts either covering
a broad region or a localized area. If 1 out of 4 enrollees was
impacted during the period of the year when the disaster hit, we
believe there is a small chance that scores may have been impacted. The
selection of the exclusion of numeric measures scores from contracts
with 60 percent or more enrollees impacted from the determination of
the cut points is conservative in case scores are impacted in contracts
where a clear majority or all of the enrollees are impacted. Using the
Individual Assistance major disaster declaration as a requirement for
the extreme and uncontrollable event policy also ensures that the
policy applies only when the event is extreme, meriting the use of
special adjustments to the Star Ratings.
We propose that contracts that do not meet the definition of an
``affected contract'' would not be eligible for any adjustments based
on the occurrence of the extreme and uncontrollable circumstances.
However, meeting the criteria to be an affected contract is not
sufficient for all the adjustments we propose.
(2) CAHPS Adjustments
For CAHPS, we propose two different types of special rules for
affected contracts: exemption from having to administer the CAHPS
survey or adjustments to the Star Ratings on the CAHPS measures if the
affected contract must administer the CAHPS survey. CAHPS measures are
based on a survey conducted early in the year in which the Star Ratings
are released that is, the year before the year to which the Star
Ratings are applicable. For example, the CAHPS survey in early 2019
will be used for the 2020 Star Ratings, which are released in late
2019, before the annual coordinated election period for 2020.
We propose at Sec. Sec. 422.166(i)(2)(i) and 423.186(i)(2)(i),
that an MA and Prescription Drug Plan contract, even if it is an
affected contract, must administer the CAHPS survey unless the contract
demonstrates to CMS that the required sample for the CAHPS survey
cannot be contacted because a substantial number of the contract's
enrollees are displaced due to a FEMA-designated disaster in the prior
calendar year and requests and receives a CMS approved exception. We
believe that displacement of a substantial number of the contract's
enrollees would make it practically impossible to contact the required
sample for the CAHPS survey. For an affected contract that receives the
exemption from administering the CAHPS survey, we propose at
422.166(i)(2)(iii) and 423.186(i)(2)(iii) that the affected contract
would receive the prior year's CAHPS measure stars (and corresponding
measure scores).
For other affected contracts, we propose an adjustment to the CAHPS
scores and Star Ratings based on the administered survey and the
percentage of enrollees in the affected contract that reside in FEMA-
designated Individual Assistance areas at the time of the extreme and
uncontrollable circumstance. We propose that affected contracts with at
least 25 percent of enrollees residing in Individual Assistance areas
at the time of the extreme and uncontrollable circumstance would
receive the higher of the previous year's Star Rating or the current
year's Star Rating (and corresponding measure score) for each CAHPS
measure (including the annual flu vaccine measure). For example, for
the 2022 Star Ratings for affected contracts, we would take the higher
of the 2021 Star Ratings or the 2022 Star Ratings for each CAHPS
measure. The affected contract would receive the CAHPS measure score
for the corresponding Star Rating year chosen. We propose the 25
percent threshold to avoid including contracts with very few enrollees
impacted. The measure-level scores for contracts with very few
enrollees impacted should not be adversely affected by these extreme
and uncontrollable circumstances. If a small percentage of enrollees
were impacted by an extreme and uncontrollable circumstance, it should
not have a significant impact on measure scores.
(3) HOS Adjustments
For the HOS survey, we propose to follow similar procedures as
CAHPS but due to the follow-up component of HOS, the adjustment would
be to the Star Ratings for the year after the completion of the follow-
up HOS survey that is administered 2 years after the baseline HOS
survey. For example, the 2022 Star Ratings are based on data collected
from April through June 2020 and reflect experiences over the past 12
months. The data collected in 2021 will be used for the 2023 Star
Ratings, so responses may reflect the impact of 2020 extreme and
uncontrollable circumstances and thus, those circumstances may have an
impact on the 2023 Star Ratings.
As described at proposed Sec. 422.166(i)(3)(i), an MA contract,
even if it is an affected contract, must administer the HOS surveys the
year after the extreme and uncontrollable circumstance unless the
contract demonstrates to CMS that the required sample cannot be
contacted because a substantial number of the contract's enrollees are
displaced due to a FEMA-designated disaster during the measurement
period and requests and receives a CMS approved exception. For an
affected contract that receives the exemption from administering the
HOS survey, we propose at paragraph (i)(3)(iii) that the affected
contract would receive the prior year's HOS and
[[Page 55027]]
HEDIS-HOS measure stars (and corresponding measure scores).
We propose at Sec. 422.166(i)(3)(iv) that the affected contracts
with at least 25 percent of enrollees residing in Individual Assistance
areas at the time of the extreme and uncontrollable circumstance would
receive the higher of the previous year's Star Rating or current year's
Star Rating for each HOS and HEDIS-HOS measure (and corresponding
measure score) for the Star Ratings 3 years after the eligible extreme
and uncontrollable circumstance. As an example, for the 2023 Star
Ratings for contracts affected by an extreme and uncontrollable
circumstance in 2020, we would take the higher of the 2022 or 2023 Star
Ratings and corresponding measure score for each HOS and HEDIS-HOS
measure.
(4) HEDIS Adjustments
For HEDIS, we propose that an MA contract, even if an affected
contract, would be required to report HEDIS data to CMS unless the
contract demonstrates to CMS an inability to obtain both administrative
and medical record data required for HEDIS measures due to a FEMA-
designated disaster in the prior calendar year and requests and
receives a CMS approved exception. All contracts in FEMA-designated
disaster areas can work with NCQA to request modifications to the
samples for measures that require medical record review. For affected
contracts that have service areas with at least 25 percent of enrollees
in a FEMA-designated Individual Assistance area at the time of the
extreme and uncontrollable circumstance, we propose to take the higher
of the previous year's Star Rating or current year's Star Rating (and
corresponding measure score) for each HEDIS measure. For example, for
the 2022 Star Ratings for affected contracts we would take the higher
of the 2021 or 2022 Star Ratings for each HEDIS measure.
(5) New Measure Adjustments
At proposed Sec. Sec. 422.166(i)(5) and 423.186(i)(3), we propose
to implement a hold harmless provision for new Star Ratings measures if
the inclusion of all applicable new measure(s) brings down the summary
and/or overall rating. That is, for affected contracts with at least 25
percent of enrollees in a FEMA-designated Individual Assistance area at
the time of the extreme and uncontrollable circumstance, all the new
measures would be excluded from the calculation of the summary and/or
overall rating if their inclusion brings a contract's summary (or in
the case of MA-PD contracts, the overall) rating down.
(6) Other Star Ratings Measure Adjustments
For all other measures for affected contracts with at least 25
percent of enrollees in a FEMA-designated Individual Assistance area at
the time of the extreme and uncontrollable circumstance (that occurs
during the measurement or performance period), we propose to take the
higher of the previous or current year's measure Star Rating (and then
use the corresponding measure score), as described at proposed
Sec. Sec. 422.166(i)(6) and 423.186(i)(4). For example, for the 2022
Star Ratings for affected contracts, we would take the higher of the
2021 or 2022 Star Ratings. We propose to exclude from this adjustment
policy the Part C Call Center--Foreign Language Interpreter and TTY
Availability and Part D Call Center--Foreign Language Interpreter and
TTY Availability measures, except for extreme and uncontrollable
circumstances where there are continuing communications issues related
to loss of electricity and damage to infrastructure during the call
center study. These measures and the underlying performance are
completely in the plan's control; we believe therefore that there
should generally be no impact from the declaration of an extreme and
uncontrollable circumstance on plan performance in these areas.
(7) Exclusion From Improvement Measures
Contracts must have data for at least half of the measures \21\
used to calculate the Part C or Part D improvement measures to be
eligible to receive a rating in each improvement measure. For affected
contracts that revert back to the data underlying the previous year's
Star Rating for a particular measure, we propose that measure would be
excluded from both the count of measures (for the determination of
whether the contract has at least half of the measures needed to
calculate the relevant improvement measure) and the applicable
improvement measures for the current and next year's Star Ratings as
stated at proposed Sec. Sec. 422.166(i)(7) and 423.186(i)(5). That is,
we would follow our usual rule where to receive a Star Rating in the
improvement measures, a contract must have measure scores for both
years in at least half of the required measures used to calculate the
Part C improvement or Part D improvement measures. The use of the data
from the previous year's Star Ratings means that there is no measure
score from the current year's Star Ratings, so the usual rule would
eliminate the measure from consideration. As an example, for affected
contracts that revert back to the 2021 Star Ratings data for a
particular measure for the 2022 Star Ratings, we would exclude that
measure from the count of measures and applicable improvement measures
for the 2022 and 2023 Star Ratings.
---------------------------------------------------------------------------
\21\ See Sec. Sec. 422.164(f) and 423.184(f) for more
information on Part C and Part D improvement measures.
---------------------------------------------------------------------------
(8) Missing Data
Except in cases where an exception was granted as described
earlier, we propose that for all measures eligible for the extreme and
uncontrollable circumstance adjustment, if an affected contract has
missing data in either the current or previous year (for example,
because of a biased rate or the contract is too new or too small), the
final measure rating would come from the current year as described at
proposed Sec. Sec. 422.166(i)(8) and 423.186(i)(6). For example, if a
contract affected by an eligible 2020 extreme and uncontrollable
circumstance was not granted an exception for data collection and does
not have sufficient data to receive a measure-level 2022 Star Rating,
it would not receive a numeric rating for that measure for the 2022
Star Ratings regardless of whether it received a numeric rating in the
previous year. Similarly, if an affected contract has missing measure
data in the previous year but received a numeric rating in the current
year, it would receive the current year's rating for its final measure
rating. In both cases, the measure would be excluded from the
contract's improvement score(s) following our usual rules.
(9) Cut Points for Non-CAHPS Measures
Currently, the Star Rating for each non-CAHPS measure is determined
by applying a clustering algorithm to the measures' numeric value
scores from all contracts required to submit the measure. The cut
points are derived from this clustering algorithm. At proposed
Sec. Sec. 422.166(i)(9) and 423.186(i)(7), we propose to exclude from
this clustering algorithm the numeric values for affected contracts
with 60 percent or more of their enrollees in the FEMA-designated
Individual Assistance area at the time of the extreme and
uncontrollable circumstance. These contracts would be excluded to
ensure that any impact of the extreme and uncontrollable circumstance
on their measure-level
[[Page 55028]]
scores would not have an impact on the cut points for other contracts.
However, these cut points calculated for all other non-affected
contracts would be used to assess these affected contracts' measure
Star Ratings. We would compare the affected contract's previous year's
measure Star Ratings to the current year's measure Star Ratings to
determine which is higher, and therefore used for the affected
contract's Star Ratings calculations, as previously discussed. For
example, for the 2022 Star Ratings we would compare the 2021 and 2022
measure Star Ratings for affected contracts.
Reward Factor. Similarly, at proposed Sec. Sec. 422.166(i)(10) and
423.186(i)(8), we propose that affected contracts with 60 percent or
more of their enrollees impacted would also be excluded from the
determination of the performance summary and variance thresholds for
the Reward Factor. However, these contracts would still be eligible for
the Reward Factor based on the mean and variance calculations of other
contracts.
In conclusion, we are proposing a new set of rules regarding
adjusting the calculation of Star Ratings for the Parts C and D
organizations who are impacted by extreme and uncontrollable
circumstances to be codified at paragraphs Sec. Sec. 422.166(i) and
423.186(i).
2. Improving Clarity of the Exceptions Timeframes for Part D Drugs
(Sec. Sec. 423.568, 423.570, and 423.572)
In this proposed rule we are proposing a change to Part D
adjudication timeframes related to exception requests in cases where a
prescribing physician's or other prescriber's supporting statement has
not been received by the plan sponsor. We are proposing to limit the
amount of time an exception request can be held open in a pending
status while the Part D plan sponsor attempts to obtain the prescribing
physician's or other prescriber's supporting statement. Section 1860D-
4(g)(2) of the Act prescribes that in the case of a drug plan that
provides for tiered cost-sharing for drugs on a formulary and provides
for lower cost-sharing for preferred drugs on a formulary, a Part D
enrollee may request an exception to the tiered cost-sharing. Under
such an exception, a non-preferred drug could be covered under the
terms applicable for preferred drugs if the prescribing physician
determines that the preferred drug for treatment of the same condition
either would not be as effective for the enrollee or would have adverse
effects or both. Part D plan sponsors are required to have an
exceptions process consistent with guidelines established by the
Secretary. These guidelines are set forth at Sec. 423.578 and permit
an enrollee to request an exception to a plan's tiered cost-sharing, an
exception for an off-formulary drug, and an exception to a utilization
management requirement. Given the language in section 1860D-4(g)(2) of
the Act referencing the determination of the prescribing physician that
the preferred drug for treating the enrollee's condition would not be
as effective, would have adverse effects, or both, the prescriber's
supporting statement is a key component to the regulations governing
the exceptions process. A plan sponsor's exceptions criteria must
include a description of the criteria the plan sponsor uses to evaluate
the prescribing physician's or other prescriber's statement. Due to the
importance of the prescriber's supporting statement in the exceptions
process, the adjudication timeframes for a coverage determination that
involves an exception request do not begin until the prescribing
physician's or other prescriber's supporting statement is received by
the Part D plan. For example, Sec. 423.568(b) states the Part D plan
sponsor must notify the enrollee (and the prescribing physician or
other prescriber involved, as appropriate) of its determination as
expeditiously as the enrollee's health condition requires, but no later
than 72 hours after receipt of the request, or, for an exception
request, the physician's or other prescriber's supporting statement.
Under current guidance, plans are instructed not to keep an exception
request open indefinitely and are instructed to apply a reasonableness
standard for holding the request open pending receipt of the
prescriber's supporting statement. Chapter 18 of the Medicare
Prescription Drug Manual instructs that if the plan does not receive
the physician's or other prescriber's supporting statement within a
reasonable period of time, the plan should make its determination based
on whatever evidence exists.
We have received feedback from plan sponsors and other stakeholders
that there should be more certainty in the timeframe applied to the
exceptions process. We are seeking to balance the importance of the
plan receiving the prescriber's supporting statement so that a thorough
decision may be made on the request and having a standard maximum time
for notifying an enrollee of an exception request decision. We believe
greater certainty in the exceptions process will be beneficial to
enrollees and plans. Establishing a fixed period in which the plan must
render a decision on an exception request may also have the effect of
more timely submission of supporting statements by prescribers once
they become familiar with the fixed timeframe in which plans must issue
a decision on an exception request. To that end, we are proposing to
amend Sec. Sec. 423.568(b), 423.570(d)(1) and 423.572(a) to state
that, for an exception request, the plan must notify the enrollee (and
the prescribing physician or other prescriber involved, as appropriate)
of its decision no later than 72 hours (or 24 hours in the case of an
expedited decision) of receipt of the prescriber's supporting statement
or 14 calendar days after receipt of the request, whichever occurs
first. Consistent with existing regulations, the plan sponsor must
notify the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of its decision on an exception request no
later than 72 hours (or 24 hours in the case of an expedited decision)
after receiving the prescriber's supporting statement. We are not
proposing a change to the existing timeframes for issuing decisions,
except that we are proposing an outside limit to the timeframe to
address instances in which a prescriber's supporting statement is not
timely received. The proposed change limits the timeframe for notifying
the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of the decision to no later than 14 calendar
days following receipt of the request. In other words, in cases where
the plan does not receive a prescriber supporting statement (or does
not receive it timely) it must notify the enrollee (and prescriber, as
appropriate) of its decision no later than 14 calendar days from the
receipt of the request. For example, if the plan sponsor receives the
prescriber's supporting statement late in the adjudication time period
(for example, on the 12th day), the plan sponsor would still be
required to notify the enrollee of its decision no later than 14
calendar days from the receipt of the request. We understand that a
supporting statement that is received late in the adjudication time
period may mean the plan sponsor has less time to conduct its review,
but we believe this circumstance is mitigated by the value in having
greater certainty in the process by establishing a maximum timeframe
for notifying the enrollee of the plan sponsor's decision. If the plan
sponsor does not have clinical support to approve the exception
request, the plan will issue the standardized denial notice and explain
in specificity the reason for the denial, the documentation needed to
approve coverage of the
[[Page 55029]]
requested drug, and the enrollee's right to request an appeal. We
believe this proposed approach affords the plan sponsor a reasonable
period of time to obtain the prescriber's supporting statement while
establishing greater certainty in the time period in which the enrollee
will receive a decision on an exception request. If the enrollee is
dissatisfied with the decision, the enrollee has the right to request
an appeal. We invite comments on this proposal.
C. Clarifying Program Integrity Policies
1. Preclusion List Requirements for Prescribers in Part D and
Individuals and Entities in MA, Cost Plans, and PACE
a. Background
In the April 2018 final rule, we removed several requirements
pertaining to MA and Part D provider and prescriber enrollment. One
requirement, outlined in Sec. 423.120(c)(6), stated that for a
prescription to be eligible for coverage under the Medicare Part D
program, the prescriber must have: (1) An approved enrollment record in
the Medicare fee-for-service program; or (2) a valid opt-out affidavit
on file with a Part A/Part B Medicare Administrative Contractor (A/B
MAC). A second requirement, outlined in Sec. 422.222, stated that
providers that furnish health care items or services to a Medicare
enrollee who receives his or her Medicare benefit through an MA
organization must be enrolled in Medicare and be in an approved status
no later than January 1, 2019. (The removal of these requirements had
been proposed in a proposed rule that appeared in the Federal Register
on November 28, 2017, titled ``Medicare Program; Contract Year 2019
Policy and Technical Changes to the Medicare Advantage, Medicare Cost
Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit
Programs, and the PACE Program'' (82 FR 56336) (hereafter referred to
as the November 2017 proposed rule)).
The overall purpose of Medicare provider enrollment is to prevent
fraud, waste, and abuse, and to protect Medicare beneficiaries, by
allowing CMS to carefully screen all providers and suppliers
(especially those that potentially pose an elevated risk to Medicare)
to confirm that they are qualified to furnish, order, certify, refer,
or prescribe Medicare items, services, or drugs. The previously
mentioned Part D and MA enrollment provisions would have supplemented
our longstanding requirements, outlined in 42 CFR part 424, subpart P
that all providers and suppliers that furnish Part A or B Medicare
items or services enroll in Medicare.
During our preparations to implement the Part D and MA enrollment
provisions by the January 1, 2019 effective date, several provider
organizations expressed concerns about our forthcoming requirements.
Regarding Part D, stakeholders expressed concerns that (1) most
prescribers pose no risk to the Medicare program, (2) certain types of
physicians and eligible professionals prescribe Part D drugs only very
infrequently, and (3) the burden to the prescriber community would
outweigh the program integrity benefits of the Part D enrollment
requirement. Regarding MA, some stakeholders were concerned about the
burden of having to enroll in Medicare, particularly considering that
health care providers in MA organization networks that would have to
enroll in Medicare must also undergo credentialing by their respective
health plans. While enrolling such prescribers and providers gives
Medicare a greater degree of scrutiny in determining a prescriber's or
provider's qualifications, we noted in the April 2018 final rule that
the perceived burden associated with this process could cause some
prescribers and providers not to enroll in Medicare, thus possibly
leading to access to care issues if such providers left MA networks as
a result. As of early 2018, approximately 420,000 Part D prescribers
and 120,000 MA providers remained unenrolled in Medicare.
Given these concerns, we stated in the April 2018 final rule our
belief that the best means of reducing the burden of the Part D and MA
enrollment requirements without compromising our payment safeguard
objectives would be to focus on prescribers and providers that pose an
elevated risk to Medicare beneficiaries and the Trust Funds. That is,
rather than require the enrollment of Part D prescribers and MA
providers regardless of the level of risk they might pose, we would
prohibit payment for Part D drugs and MA items or services that are, as
applicable, prescribed or furnished by demonstrably problematic
prescribers and providers. Therefore, we established in the April 2018
final rule a policy under which: (1) Such problematic parties would be
placed on a ``preclusion list''; and (2) payment for Part D drugs and
MA services and items prescribed or furnished by these individuals and
entities would be rejected or denied, as applicable.
For purposes of this proposed rule, the most pertinent policies we
finalized in the April 16, 2018 rule included the following:
In Sec. 423.100 (for Part D) and Sec. 422.2 (for MA), we
stated that the term ``preclusion list'' means a CMS-compiled list of,
as applicable, prescribers and providers that:
++ Meet all of the following requirements:
++ The individual or entity is currently revoked from the Medicare
program under Sec. 424.535.
++ The individual or entity is currently under a reenrollment bar
under Sec. 424.535(c).
++ CMS determines that the underlying conduct that led to the
revocation is detrimental to the best interests of the Medicare
program. In making this determination under this paragraph, CMS
considers the following factors:
--The seriousness of the conduct underlying the individual's or
entity's revocation.
--The degree to which the individual's or entity's conduct could affect
the integrity of the Part D or MA program.
--Any other evidence that CMS deems relevant to its determination; or
++ Meet both of the following requirements:
++ The individual or entity has engaged in behavior for which CMS
could have revoked the individual or entity to the extent applicable if
they had been enrolled in Medicare.
++ CMS determines that underlying conduct that led to the
revocation is detrimental to the best interests of the Medicare
program. In making this determination under this paragraph, CMS
considers the following factors:
--The seriousness of the conduct underlying the individual's or
entity's revocation.
--The degree to which the individual's or entity's conduct could affect
the integrity of the Part D or MA program.
--Any other evidence that CMS deems relevant to its determination.
We revised and added various provisions in 42 CFR part
498, subpart A, that permitted individuals and entities to appeal their
inclusion on the preclusion list. Specifically:
++ We added a new paragraph (20) to Sec. 498.3(b) stating that a
CMS determination to include an individual or entity on the preclusion
list constitutes an initial determination.
++ In Sec. 498.5, we added a new paragraph (n) containing the
following provisions:
--In paragraph (n)(1), we stated that any individual or entity
dissatisfied with an initial determination or revised initial
determination that they are to be included on the preclusion list may
request a reconsideration in accordance with Sec. 498.22(a).
[[Page 55030]]
--In paragraph (n)(2), we stated that if CMS or the individual or
entity under paragraph (n)(1) is dissatisfied with a reconsidered
determination under paragraph (n)(1), or a revised reconsidered
determination under Sec. 498.30, CMS or the individual or entity is
entitled to a hearing before an administrative law judge (ALJ).
--In paragraph (n)(3), we stated that if CMS or the individual or
entity under paragraph (n)(2) is dissatisfied with a hearing decision
as described in paragraph (n)(2), CMS or the individual or entity may
request review by the Departmental Appeals Board (DAB) and the
individual or entity may seek judicial review of the DAB's decision.
In Sec. 423.120(c)(6)(v) (for Part D) and Sec.
422.222(a)(2) (for MA), we stated that CMS would send written notice to
the individual or entity via letter of their inclusion on the
preclusion list. The notice would contain the reason for said inclusion
and would inform the individual or entity of their appeal rights. We
further stated that the affected party could appeal their inclusion on
the preclusion list in accordance with Part 498.
We stated in Sec. 423.120(c)(6)(iv)(A) that a Part D
sponsor or its Pharmacy Benefit Manager (PBM) must not reject a
pharmacy claim or request for reimbursement for a Part D drug unless
the sponsor has provided the written notice to the beneficiary
described in Sec. 423.120(c)(6)(iv)(B). Under paragraph (iv)(B), the
Part D sponsor or its PBM must:
++ Provide an advance written notice to any beneficiary who has
received a prescription from a prescriber on the preclusion list as
soon as possible but to ensure that the beneficiary receives the notice
no later than 30 days after the publication of the most recent
preclusion list; and
++ Ensure that reasonable efforts are made to notify the prescriber
of a beneficiary who was sent a notice under paragraph (iv)(B).
We stated in the preamble to the April 2018 final rule
that individuals and entities would only be placed on the preclusion
list upon exhausting their first level of appeal.
In the preamble to the previously mentioned November 2017
proposed rule (82 FR 56446), we stated that if a beneficiary's access
to a service, item, or drug is denied because of the application of the
preclusion list to his or her prescriber or provider, the beneficiary
would be permitted to appeal alleged errors in applying the preclusion
list. However, in the April 2018 final rule (83 FR 16660), we stated
that if payment is denied because the prescriber or provider is on the
preclusion list, the beneficiary would not have the right to appeal.
We stated in April 2018 final rule (83 FR 16642) that an
unenrolled individual or entity would remain on the preclusion list for
the same length of time as the reenrollment bar that we could have
imposed on the individual or entity had they been enrolled in Medicare
and then revoked.
In addition, we stated that the preclusion list provisions in the
April 2018 final rule (83 FR 16440) were to become effective on January
1, 2019.
b. Proposed Changes
For reasons stated in this section III.C.1.b. of this proposed
rule, we propose to make changes to several of the preclusion list
policies outlined in the April 2018 final rule.
(1) Appeals Process for Individuals and Entities on the Preclusion List
Similar to individuals and entities that are placed on the
preclusion list, providers and suppliers whose Medicare enrollment is
revoked for one or more of the revocation reasons described in Sec.
424.535 (for example, the provider submitted false information to
Medicare, has engaged in abusive prescribing of Part D drugs, or is
excluded by the Office of Inspector General (OIG)) may appeal such
revocation under Sec. 498.5(l). Under Sec. 498.22(b)(3), the provider
or supplier has 60 days from receipt of the notice of revocation from
CMS or its contractor to request a reconsideration, which is considered
the first level of appeal. CMS has 90 days to render its
reconsideration decision and to notify the provider or supplier
thereof.
As already mentioned, under Sec. 423.100 (for Part D) and Sec.
422.2 (for MA), an individual or entity may be placed on the preclusion
list if their Medicare enrollment is revoked, the individual or entity
is currently under a reenrollment bar, and CMS determines that the
underlying conduct that led to the revocation is detrimental to the
best interests of the Medicare program. Having stated in the April 2018
final rule (83 FR 16662) that individuals and entities would only be
placed on the preclusion list upon exhausting their first level of
appeal, we are concerned that there could be a very lengthy delay
before the individual or entity is actually placed on said list. This
is because the individual or entity, under existing regulations, would
be able to first appeal their revocation and, if unsuccessful, could
next appeal their placement on the preclusion list because of the
revocation. Consider the following example:
A provider receives a revocation notice on March 1.
The provider has until April 30 (or 60 days) to file a
request for reconsideration.
CMS has until July 29 (or 90 days) to render its
reconsideration decision.
CMS sends notice of its denial of the provider's
reconsideration on July 29, at which point the revoked provider has
until September 28 (or 60 days from the date of the notice) to now
request a reconsideration of its inclusion on the preclusion list.
The provider requests a reconsideration of its inclusion
on the preclusion list on September 28.
CMS has until December 27 (or 90 days) to render its
reconsideration decision.
CMS sends notice of its denial of the provider's
reconsideration on December 27.
With the first level of appeal completed, the provider is
placed on the preclusion list.
The end result of this process is that it could take up to nearly 9
months before a provider is placed on the preclusion list, meaning
that, for instance, a prescriber who was revoked for a felony
conviction could continue to prescribe covered Part D drugs for an
extended period before placement on the preclusion list results in a
prohibition against payment by a Part C plan, Medicare cost plan, Part
D plan, or PACE organization to the prescriber (for any health care
services furnished) for the prescribed drug. This is inconsistent with
the principal goal of the preclusion list, which is to prevent payment
for Part D drugs or MA services or items prescribed or furnished, as
applicable, by problematic parties. Such a lengthy delay could place
Medicare beneficiaries and the Trust Funds at risk.
We believe that an appropriate balance can be found between
preserving a prescriber's or provider's appeal rights and ensuring that
problematic parties are placed on the preclusion list as soon as
feasible. To facilitate this objective, we propose several regulatory
changes that would consolidate the revocation and preclusion list
appeals processes so that they run concurrently, rather than
consecutively. This means, in effect, that if a prescriber or provider
is to be placed on the preclusion list in conjunction with a revocation
under Sec. 424.535, no more than 5 months would expire before the
preclusion list inclusion occurs. Though we recognize
[[Page 55031]]
that 5 months is not an inconsiderable length of time, it would be
preferable to the previously referenced 9-month period while still
ensuring that affected prescribers and providers have an opportunity to
be heard.
The specific regulatory revisions we propose regarding this issue
are as follows:
In Sec. 423.120(c)(6)(v), we propose to:
++ Consolidate the existing version of paragraph (v) into a revised
Sec. 423.120(c)(6)(v)(A).
++ Establish a new Sec. 423.120(c)(6)(v)(B) stating that in
situations where the prescriber's inclusion on the preclusion list is
based on a contemporaneous Medicare revocation under Sec. 424.535:
--The notice described in paragraph (c)(6)(v)(A) must also include
notice of the revocation, the reason(s) for the revocation, and a
description of the prescriber's appeal rights concerning the
revocation.
--The appeals of the prescriber's inclusion on the preclusion list and
the prescriber's revocation shall be filed jointly by the prescriber
and, as applicable, considered jointly by CMS under 42 CFR part 498.
In Sec. 422.222(a)(2), we propose to do the following:
++ Move the existing version of this paragraph into a new Sec.
422.222(a)(2)(i).
++ Establish a new Sec. 422.222(a)(2)(ii) stating that in
situations where the individual's or entity's inclusion on the
preclusion list is based on a contemporaneous Medicare revocation under
Sec. 424.535:
--The notice described in paragraph (a)(2)(i) must also include notice
of the revocation, the reason(s) for the revocation, and a description
of the individual's or entity's appeal rights concerning the
revocation.
--The appeals of the individual's or entity's inclusion on the
preclusion list and the individual's or entity's revocation shall be
filed jointly by the individual or entity and, as applicable,
considered jointly by CMS under 42 CFR part 498.
In Sec. 498.5(n)(1), we propose to do the following:
++ Move the existing version of this paragraph to a new Sec.
498.5(n)(1)(i).
++ Establish a new Sec. 498.5(n)(1)(ii)(A) stating that in
situations where the individual's or entity's inclusion on the
preclusion list is based on a Medicare revocation under Sec. 424.535
and the individual or entity receives contemporaneous notice of both
actions, the individual or entity may request a joint reconsideration
of both the preclusion list inclusion and the revocation in accordance
with Sec. 498.22(a).
++ Establish a new Sec. 498.5(n)(1)(ii)(B) stating that the
individual or entity may not submit separate reconsideration requests
under paragraph (ii)(A) for inclusion on the preclusion list or a
revocation if the individual or entity received contemporaneous notice
of both actions.
We believe these changes would clarify our expectations and the
program procedures concerning the filing of appeals when a party's
placement on the preclusion list is based on a Medicare revocation. We
also stress that our proposed appeals consolidation would not affect
appeals of OIG exclusions, which are handled through a separate process
outlined in the applicable OIG regulations.
(2) Timing of Addition to the Preclusion List
Although, as mentioned previously, we stated in the April 2018
final rule (83 FR 16662) that prescribers and providers would only be
placed on the preclusion list upon exhausting their first level of
appeal, we did not include this language in the regulatory text. We
propose to do so in this proposed rule to reiterate our position on
this important issue. We believe that fairness warrants that the
affected prescriber or provider have an opportunity to be heard before
being included on the preclusion list. Therefore, we propose in new
Sec. 423.120(c)(6)(v)(C)(1) (for Part D) and new Sec.
422.222(a)(3)(i) (for MA) that, respectively, a prescriber or provider
would only be included on the preclusion list after the expiration of
either of the following:
If the prescriber or provider does not file a
reconsideration request under Sec. 498.5(n)(1), the prescriber or
provider will be added to the preclusion list upon the expiration of
the 60-day period in which the prescriber or provider may request a
reconsideration.
If the prescriber or provider files a reconsideration
request under Sec. 498.5(n)(1), the prescriber or provider will be
added to the preclusion list effective on the date on which CMS, if
applicable, denies the prescriber's or provider's reconsideration.\22\
---------------------------------------------------------------------------
\22\ In the April 2018 final rule, we adopted cross-references
in 42 CFR parts 417 and 460 to Part 422 so that our MA preclusion
list provisions in that rule would also apply to, respectively, cost
plans (Part 417) and PACE organizations (Part 460). Consistent with
said cross-references, our MA preclusion list provisions in this
proposed rule would similarly apply to cost plans and PACE
organizations.
---------------------------------------------------------------------------
However, we also believe that an exception to these proposed
policies is necessary for preclusion list inclusions that are based on
an OIG exclusion. This is because section 1862(e) of the Act (42 U.S.C.
1395y(e)) is clear that no federal health care program payment may be
made for any items or services furnished by an excluded individual or
entity, or directed or prescribed by an excluded physician. We believe
that a failure to add an excluded provider or prescriber to the
preclusion list until the expiration of the applicable time periods in
Sec. 423.120(c)(6)(v)(C)(1) (for Part D) and Sec. 422.222(a)(3)(i)
(for MA) would be inconsistent with section 1862(e) of the Act.
Accordingly, we propose in new Sec. 423.120(c)(6)(v)(C)(2) (for Part
D) and Sec. 422.222(a)(3)(ii) (for MA) that an excluded prescriber or
provider would be added to the preclusion list effective on the date of
the exclusion.
(3) Effective Date
We propose that, with one exception, the preclusion list regulatory
revisions and additions addressed in this proposed rule would become
applicable to MA organizations (and cost plans and PACE organizations
by virtue of cross-references in parts 417 and 460 to the MA part 422
regulation) and Part D plans on January 1, 2020. Considering the need
to ensure that stakeholders have as much time as possible to prepare
for these revisions and additions, we believe that a January 1, 2020
effective date is appropriate. However, we also propose that the
effective date of our previously mentioned consolidated appeals
provisions in Sec. Sec. 423.120(c)(6)(v), 422.222(a)(2), and Sec.
498.5(n)(1) would be 60 days after their publication in a final rule.
As discussed in section C.1.b.(1) above, it is important that
problematic providers be placed on the preclusion list as soon as
possible; for this reason, we believe it would be inconsistent with
CMS' program integrity objectives to wait until January 1, 2020 to
implement our consolidated appeals provisions. We also solicit public
comments on whether some or all of our other proposed preclusion list
provisions discussed in this section III.C.1. of this proposed rule
should become effective and applicable beginning 60 days after the
publication date of this proposed rule.
We note that the January 1, 2019 preclusion list effective date
identified in the April 2018 final rule remains in place, and the
preclusion list provisions finalized in that rule will continue to be
implemented on January 1, 2019.
[[Page 55032]]
(4) Claim Denials and Beneficiary Notification
We stated in the April 2018 final rule (83 FR 16440) that, upon
CMS' publication of the first preclusion list, once a prescriber or
provider is added to such initial list after the completion of their
first level of appeal, claims would not be impacted for a 90-day period
thereafter (82 FR 16667). We explained that this 90-day period would
include--(1) a 30-day period for the plans and MA organizations to
intake the preclusion list data; and (2) a 60-day period in which the
plan or MA organization would (a) notify the beneficiary of the
prescriber's or provider's preclusion and (b) work to transition the
beneficiary to a new prescriber or provider. Once this 90-day period
expires, claim denials would commence.
The purpose of this policy was to give Part D plans and MA
organizations additional time immediately following the January 1, 2019
effective date to accustom themselves to the preclusion list process
and file layout. We also believed that beneficiaries should be given
advance notice that, as applicable, certain Part D drugs and MA
services and items they receive as patients of the precluded prescriber
or provider would no longer be covered as of the expiration of the 90-
day period. However, we emphasized that all subsequent updates to the
preclusion list, that is, all updates after the release of the initial
preclusion list--would not require the expiration of a 90-day period
before claims were denied. There were two reasons for this. First, we
did not believe that the plans and MA organizations would need the
aforementioned 30-day period any longer, for they would have become
better acclimated to the operational aspects of the preclusion list
process. Second, since most of the parties included on the initial
preclusion list would remain on it in subsequent updates and,
accordingly, affected beneficiaries would already have received notice
of their prescriber's or provider's appearance on the initial
preclusion list, we did not believe that repeated, monthly notices to
beneficiaries thereafter would be warranted. As such, for subsequent
preclusion list updates, claim denials would begin effective upon the
date the prescriber or provider was included on the preclusion list,
which, as indicated previously, would be that specified in revised
Sec. 423.120(c)(6)(v) and new Sec. 422.222(a)(3).
Upon further consideration, we are concerned that beneficiaries
whose prescribers and providers are added to subsequent updates to the
preclusion list would not receive any notice of those additions nor of
the consequences of placement of such providers and prescribers on the
preclusion list. This could greatly impede the ability of enrollees to
obtain needed services, items, or drugs for an extended period of time;
indeed, by the time a beneficiary learns of his or her prescriber's or
provider's inclusion on the preclusion list (through, for instance,
receipt of a claim denial) and he or she thereafter manages to find a
new prescriber or provider, many months could elapse. We believe that
such situations must be avoided and, to that end, that the previously
mentioned notification requirement and delayed denial of claims for the
initial preclusion list should apply to each subsequent update as well.
Accordingly, we propose that claim denials for preclusion list updates,
beginning in 2020, would occur consistent with the following timeframes
listed below (although we would recommend that plans implement these
timeframes for any updates to the preclusion list posted in 2019
subsequent to the initial preclusion list):
Upon the posting of the updated preclusion list, the Part
D sponsor or MA organization would be required to send notice to the
beneficiary that his or her prescriber or provider has been added to
preclusion list within 30 days of the posting of the updated preclusion
list. We believe a 30-day period is necessary to allow the plans to
carefully review the preclusion list updates to identify new or removed
prescribers or providers, make any applicable operational adjustments,
and send notices to beneficiaries whose prescribers or providers are
now on the preclusion list.
Beginning 60 days after sending the beneficiary notice(s)
described in the previous paragraph, the plan sponsor or MA
organization would deny the prescriber's or provider's prescriptions or
claims. This 60-day period would give beneficiaries time to locate
another prescriber or provider from whom they can receive Part D
prescriptions or MA services and items.
With these timeframes, therefore, a total period of 60 to 90 days
(depending chiefly on when the beneficiary notification is sent) would
elapse between the date on which the preclusion list update is posted
and the date on which claims denials would begin. We recognize that
applying this 60- to 90-day period to subsequent updates (rather than
exclusively to the initially posted list) could result in a precluded
prescriber or provider being permitted to continue treating Part D and
MA beneficiaries for several months without their Part D prescriptions
or MA claims being denied. However, we believe that the prevention of
potentially serious dangers to the health and safety of Medicare
beneficiaries that could ensue if they are without crucial medications
for an extended period must take precedence.
Although, as already mentioned, we discussed the delayed claim
denial period in the April 2018 final rule (83 FR 16441), we did not
incorporate this policy into the regulatory text. Further, while Sec.
423.120(c)(6) contains certain provisions regarding preclusion list
beneficiary notification, there are no such concomitant provisions for
MA in Sec. 422.222. Thus, we propose to make the following revisions
and additions, as applicable, to Sec. 423.120(c)(6) and Sec. 422.222
in this proposed rule in order to incorporate our beneficiary
notification proposals:
Section 422.222 would be revised as follows:
++ Existing paragraph (a)(1) would be moved to a new paragraph
(a)(1)(i) that would state: ``Except as provided in paragraph
(a)(1)(ii) of this section, an MA organization must not make payment
for a health care item or service furnished by an individual or entity
that is included on the preclusion list, defined in Sec. 422.2.''
++ New paragraph (a)(1)(ii) would state: ``With respect to MA
providers that have been added to an updated preclusion list, the MA
organization must do all of the following:''
++ New paragraph (a)(1)(ii)(A) would state: ``No later than 30 days
after the posting of this updated preclusion list, must provide an
advance written notice to any beneficiary who has received an MA
service or item from the individual or entity added to the preclusion
list in this update.''
++ New paragraph (a)(1)(ii)(B) would state: ``Must ensure that
reasonable efforts are made to notify the individual or entity
described in paragraph (a)(1)(ii) of this section of a beneficiary who
was sent a notice under paragraph (a)(1)(ii)(A) of this section; and''
++ New paragraph (a)(1)(ii)(C) would state: ``Must not deny payment
for a service or item furnished by the newly added individual or
entity, solely on the ground that they have been included in the
updated preclusion list, in the 60-day period after the date it sent
the notice described in paragraph (a)(1)(ii)(A) of this section.''
Under the MA regulation at 42 CFR 422.224, MA organizations are
prohibited from paying individuals and entities that are on the CMS
preclusion
[[Page 55033]]
list. We understand that this language includes both contracted and
non-contracted parties; therefore, this prohibition against paying
precluded individuals and entities would include contracted and non-
contracted parties for purposes of the provisions in Sec.
422.222(a)(1), for we believe it is necessary to ensure that the scope
of the payment prohibition in the latter section aligns with that
already established in Sec. 422.224. Further, we believe that applying
this requirement to both contracted and non-contracted parties better
safeguards our beneficiaries while also increasing consistency by
aligning with the OIG exclusion process, which is also applied to both
contracted and non-contracted parties.
Consistent with our proposed changes to Sec. 422.222(a)(1), we
propose to delete the existing structure of Sec. 423.120(c)(6)(iv),
which we cited previously, and replace it with the following:
++ A new opening paragraph of (c)(6)(iv) would state:
``With respect to Part D prescribers that have been added to an
updated preclusion list, the Part D plan sponsor must do all of the
following:''
++ Revised paragraph (c)(6)(iv)(A) would state: ``Subject to all
other Part D rules and plan coverage requirements, and no later than 30
days after the posting of this updated preclusion list, must provide an
advance written notice to any beneficiary who has received a Part D
drug prescribed by a prescriber added to the preclusion list in this
update.''
++ Revised paragraph (c)(6)(iv)(B) would state: ``Must ensure that
reasonable efforts are made to notify the prescriber described in
paragraph (c)(6)(iv) of this section of a beneficiary who was sent a
notice under paragraph (c)(6)(iv)(A) of this section; and''
++ New paragraph (c)(6)(iv)(C) would state: ``Must not reject a
pharmacy claim or deny beneficiary request for reimbursement for a Part
D drug prescribed by the prescriber, solely on the ground that they
have been included in the updated preclusion list, in the 60-day period
after the date it sent the notice described in paragraph (c)(6)(iv)(A)
of this section.''
For providers and prescribers that are both on the preclusion list
and excluded by the OIG, the aforementioned beneficiary notification
process would not be intended to replace or supplant any existing OIG
processes for notifying beneficiaries of excluded providers or
prescribers.
(5) Beneficiary Appeals
We mentioned earlier that in the preamble to the April 2018 final
rule, we stated that if payment is denied because the prescriber or
provider is on the preclusion list, the affected beneficiary would not
have the right to appeal that denial. However, we did not include
accompanying regulatory text in the final rule. To remedy this, we
propose to add new Sec. 423.120(c)(6)(viii) and Sec. 422.222(a)(4)
stating that payment denials based upon, respectively, a prescriber's
or provider's inclusion on the preclusion list are not appealable by
beneficiaries.
(6) Felony Convictions
We proposed in the November 2017 proposed rule to keep unenrolled
prescribers and providers on the preclusion list for the same length of
time as the reenrollment bar that we could have imposed on the
prescriber or provider had they been enrolled and then revoked. While
this policy was finalized in the April 2018 final rule, it was not
included in the regulatory text. Given this, we propose several
regulatory revisions.
First, we propose to revise the definitions of ``preclusion list''
in Sec. Sec. 423.100 and 422.2. The current definitions contain two
general categories of parties that could be included on the preclusion
list--(1) prescribers and providers that are currently revoked from
Medicare and are under a reenrollment bar; and (2) prescribers and
providers that have engaged in behavior for which CMS could have
revoked the prescriber or provider to the extent applicable had they
been enrolled in Medicare. Although these two categories encompass
felony convictions, we believe that the severity of felonious behavior
warrants the establishment of a third category that is specific to
felony convictions. Therefore, we propose to remove felony convictions
from the scope of the first two categories, with the new third category
covering prescribers and providers--regardless of whether they are or
were enrolled in Medicare--that have been convicted of a felony under
federal or state law within the previous 10 years that CMS deems
detrimental to the best interests of the Medicare program; we note that
this language is consistent with that in the current version of Sec.
424.535(a)(3), which permits CMS to revoke a provider's or supplier's
enrollment based on a federal or state felony conviction within the
past 10 years. Recognizing, however, that the facts of each case are
different and must be judged on their own merits, we propose that CMS
would first consider the following factors before determining whether a
prescriber's or provider's inclusion on the preclusion list is
warranted under our new proposed third category for felony convictions:
(1) The severity of the offense; (2) when the offense occurred; and (3)
any other information that CMS deems relevant to its determination. We
also acknowledge that with the expansion of the number of preclusion
list categories from two to three, we must, and propose to, add an
``or'' to the regulatory text immediately after the second category in
the preclusion list definitions. This would clarify that a prescriber
or provider need only come within the purview of one of the three
categories to be included on the preclusion list.
Second, we propose to establish new Sec. Sec. 423.120(c)(6)(vii)
and 422.222(a)(5) that would codify, clarify, and expand upon the
previously mentioned policy concerning the length of a prescriber's or
provider's inclusion on the preclusion list:
In Sec. Sec. 423.120(c)(6)(vii)(A) and 422.222(a)(5)(i),
we propose that, except as provided in Sec. Sec. 423.120(c)(6)(vii)(C)
and (D) and 422.222(a)(5)(iii) and (iv), revoked prescribers and
providers, respectively, would be included on the preclusion list for
the same length of time as the prescriber's or provider's reenrollment
bar. This would be consistent with our intended, though uncodified,
policy in the April 2018 final rule (83 FR 16441).
In Sec. Sec. 423.120(c)(6)(vii)(B) and 422.222(a)(5)(ii),
we propose that, except as provided in Sec. Sec. 423.120(c)(6)(vii)(C)
and (D) and 422.222(a)(5)(iii) and (iv), unenrolled prescribers and
providers, respectively, would be included on the preclusion list for
the same length of time as the reenrollment bar that we could have
imposed on the prescriber or provider had they been enrolled and then
revoked. This would codify the previously mentioned policy concerning
the period of time that unenrolled providers and suppliers would remain
on the preclusion list.
In Sec. Sec. 423.120(c)(6)(vii)(C) and
422.222(a)(5)(iii), we propose that, except as provided in Sec. Sec.
423.120(c)(6)(vii)(D) and 422.222(a)(5)(iv), prescribers and
providers--regardless of whether they are or were enrolled in
Medicare--that are included on the preclusion list because of a felony
conviction will remain on the preclusion list for a 10-year period,
beginning on the date of the felony conviction, unless CMS determines
that a shorter time length of
[[Page 55034]]
time is warranted. Factors that we would consider in making such a
determination would be: (1) The severity of the offense; (2) when the
offense occurred; and (3) any other information that CMS deems relevant
to its determination.
We believe that the seriousness of certain types of felonious
behavior could, in some cases, warrant the prescriber's or provider's
inclusion on the preclusion list for a very lengthy period of time.
Indeed, we recognized this in a proposed rule published in the Federal
Register on March 1, 2016 titled ``Medicare, Medicaid, and Children's
Health Insurance Programs; Program Integrity Enhancements to the
Provider Enrollment Process'' (81 FR 10720). We proposed in this
proposed rule to extend the maximum reenrollment bar under Sec.
424.535(c) from 3 years to 10 years so that the Medicare program, the
Medicare Trust Funds, and beneficiaries could be protected from
providers that engaged in especially egregious activities, including
felonies. To ensure such protections, we believe that a maximum 10-year
preclusion list period for felony convictions is justified. Conversely,
because certain felonies may not warrant a 10-year inclusion on the
preclusion list, we believe that certain factors, as already described,
should be weighed in determining the applicable timeframe.
We emphasize that because our proposed preclusion list period for
felonious prescribers and providers would begin on the date of the
conviction, such parties may be included on the preclusion list for
less than 10 years even if CMS imposes the full 10-year period. To
illustrate, assume that a physician is convicted of a felony on January
2, 2020. CMS imposes a 10-year preclusion list period, and he is added
to the preclusion list on June 2, 2020. Because the 10-year period
commences on the date of the conviction (January 2, 2020), the
physician would only be on the preclusion list for 9 years and 6
months.
The OIG in many cases excludes providers and prescribers for a
period that is longer than the period permitted for a reenrollment bar
under Sec. 424.535(c). As discussed previously, section 1862(e) of the
Act is clear that no federal health care program payment may be made
for any items or services furnished by an excluded individual or
entity, or directed or prescribed by an excluded physician. We believe
that CMS should keep an excluded provider or prescriber on the
preclusion list at least until the provider or prescriber has been
reinstated by the OIG in order to be consistent with section 1862(e) of
the Act. Consequently, we propose in new Sec. 423.120(c)(6)(vii)(D)
and 422.222(a)(5)(iv) that in cases where a prescriber or provider is
excluded by the OIG, the prescriber or provider remains on the
preclusion list until the expiration of the CMS-imposed preclusion list
period or reinstatement by the OIG, whichever occurs later.
(7) Beneficiary Liability
During the notice and comment period for the November 2017 proposed
rule (82 FR 16664), we received a comment recommending that in CMS'
implementation of the preclusion list, the beneficiary should be held
harmless unless the beneficiary engaged in fraudulent activity. We
interpreted this comment to be, in the context of MA, that the
beneficiary should not be held financially liable if the MA provider
that furnished to him or her the service or item in question is on the
preclusion list. We generally agreed with this, noting in our response
to said comment:
The contract provisions required between the MA plan and a
network provider in accordance with Sec. 422.504(g)(1)(iii) are
binding on providers. Such agreements specify that Qualified Medicare
Beneficiary (QMB) programs must not be charged cost sharing when the
state is responsible for paying such amounts under the Medicaid
program.
Section 422.504(g) contains broader beneficiary protection
requirements for MA organizations. This includes a requirement that the
plan must indemnify the beneficiary from any fees that are the legal
obligation of the MA organization for services furnished by providers
that do not contract, or that have not otherwise entered into an
agreement, with the MA organization, to provide services to the
organization's enrollees.
Section 422.504 outlines provisions that a contract between an MA
organization and CMS must contain. Paragraph (g) thereof outlines
requirements to which the MA organization must agree; under paragraph
(g)(1), each MA organization must adopt and maintain arrangements
satisfactory to CMS to protect its enrollees from incurring liability
(for example, as a result of an organization's insolvency or other
financial difficulties) for payment of any fees that are the legal
obligation of the MA organization. To implement our overall position as
it pertains to the preclusion list, we believe that a specific addition
to Sec. 422.504(g)(1) is necessary. Consistent with our existing
authority under section 1857(e)(1) of the Act, we thus propose to add a
new paragraph (g)(1)(iv) to Sec. 422.504 under which the MA
organization agrees that the enrollee must not have any financial
liability for services or items furnished to the enrollee by an MA
contracted individual or entity on the preclusion list, as defined in
Sec. 422.2 and as described in Sec. 422.222. We acknowledge that the
effect of this provision would be limited to providers under contract
with the MA organization, for we believe this is consistent with the
general applicability and scope of Sec. 422.504 and the ability of the
MA organization to control or impose requirements on the health care
providers that furnish covered services and items to enrollees.
Nonetheless, we believe that proposed paragraph (g)(1)(iv) would help
financially protect beneficiaries from problematic providers as well as
codify the previously mentioned position we expressed in the preamble
of the April 2018 final rule (83 FR 16646) but did not address in the
regulatory text.
(8) Technical Correction Concerning the Term ``Individual'' (Sec.
423.120(c)(6))
We also propose to make technical changes to Sec.
423.120(c)(6)(i), (ii), (iii), and (vi). These paragraphs state as
follows, respectively:
Except as provided in paragraph (c)(6)(iv) of this
section, a Part D sponsor must reject, or must require its PBM to
reject, a pharmacy claim for a Part D drug if the individual who
prescribed the drug is included on the preclusion list, defined in
Sec. 423.100.
Except as provided in paragraph (c)(6)(iv) of this
section, a Part D sponsor must deny, or must require its PBM to deny, a
request for reimbursement from a Medicare beneficiary if the request
pertains to a Part D drug that was prescribed by an individual who is
identified by name in the request and who is included on the preclusion
list, defined in Sec. 423.100.
A Part D plan sponsor may not submit a prescription drug
event (PDE) record to CMS unless it includes on the PDE record the
active and valid individual NPI of the prescriber of the drug, and the
prescriber is not included on the preclusion list, defined in Sec.
423.100, for the date of service.
CMS has the discretion not to include a particular
individual on (or if warranted, remove the individual from) the
preclusion list should it determine that exceptional circumstances
exist regarding beneficiary access to prescriptions.
Because some states permit pharmacies to prescribe medications, we
believe that the use of the term ``individual'' in paragraphs (i),
(ii), (iii), and (vi) is too restrictive. We therefore
[[Page 55035]]
propose in paragraphs (i), (ii), and (vi) to change this term to
``prescriber'' so as to clarify that the prescriber need not be an
individual. In a similar vein, we propose:
In Sec. 423.120(c)(6)(iii) to change the phrase
``individual NPI of the prescriber'' to ``NPI of the prescriber'', and
In paragraph (2)(i) of the definition of ``preclusion
list'' in Sec. 423.100 (and as reflected in our previously discussed
proposal to revise this paragraph (see section II.C.1.b.6. of this
proposed rule)) to change the phrase ``he or she'' to ``prescriber.''
(9) Proposed Provisions
Given the foregoing, we propose the following changes:
We would revise the definition of ``preclusion list'' in
Sec. 422.2 as follows:
++ Paragraph (1)(i) of the definition would be changed from ``the
individual or entity is currently revoked from Medicare under Sec.
424.535'' to ``the individual or entity is currently revoked from
Medicare for a reason other than that stated in Sec. 424.535(a)(3) of
this chapter.''
++ Paragraph (2)(i) of the definition would be changed from ``the
individual or entity has engaged in behavior for which CMS could have
revoked the individual or entity to the extent applicable had they been
enrolled in Medicare'' to ``the individual or entity has engaged in
behavior, other than that described in Sec. 424.535(a)(3) of this
chapter, for which CMS could have revoked the individual or entity to
the extent applicable had they been enrolled in Medicare.''
++ We would add the word ``or'' to the end of paragraph (2)(ii)(C)
of the definition.
++ New paragraph (3) would read as follows: ``The individual or
entity, regardless of whether they are or were enrolled in Medicare,
has been convicted of a felony under federal or state law within the
previous 10 years that CMS deems detrimental to the best interests of
the Medicare program. Factors that CMS considers in making such a
determination under this paragraph are: (1) The severity of the
offense; (2) when the offense occurred; and (3) any other information
that CMS deems relevant to its determination.''
We would revise Sec. 422.222 such that it would read as
follows:
++ Existing paragraph (a)(1) would be moved to a new paragraph
(a)(1)(i) that would state: ``Except as provided in paragraph
(a)(1)(ii) of this section, an MA organization must not make payment
for a health care item or service furnished by an individual or entity
that is included on the preclusion list, defined in Sec. 422.2.''
++ New paragraph (a)(1)(ii) would state: ``With respect to MA
providers that have been added to an updated preclusion list, the MA
organization must do all of the following:''
++ New paragraph (a)(1)(ii)(A) would state: ``No later than 30 days
after the posting of this updated preclusion list, must provide an
advance written notice to any beneficiary who has received an MA
service or item from the individual or entity added to the preclusion
list in this update;''
++ New paragraph (a)(1)(ii)(B) would state: ``Must ensure that
reasonable efforts are made to notify the individual or entity
described in paragraph (a)(1)(ii) of this section of a beneficiary who
was sent a notice under paragraph (a)(1)(ii)(A) of this section; and
++ New paragraph (a)(1)(ii)(C) would state: ``Must not deny payment
for a service or item furnished by the newly added individual or
entity, solely on the ground that they have been included in the
updated preclusion list, in the 60-day period after the date it sent
the notice described in paragraph (a)(1)(ii)(A) of this section.''
++ In new Sec. 422.222(a)(2)(i), we propose to incorporate therein
the current version of Sec. 422.222(a)(2).
++ New Sec. 422.222(a)(2)(ii) would state: ``If the individual's
or entity's inclusion on the preclusion list is based on a
contemporaneous Medicare revocation under Sec. 424.535 of this
chapter:''.
++ New Sec. 422.222(a)(2)(ii)(A) would state: ``The notice
described in paragraph (a)(2)(i) of this section must also include
notice of the revocation, the reason(s) for the revocation, and a
description of the individual's or entity's appeal rights concerning
the revocation.''
++ New Sec. 422.222(a)(2)(ii)(B) would state: ``The appeals of the
individual's or entity's inclusion on the preclusion list and the
individual's or entity's revocation shall be filed jointly by the
individual or entity and, as applicable, considered jointly by CMS
under 42 CFR part 498 of this chapter.
++ New Sec. 422.222(a)(3)(i) would state: ``Except as provided in
paragraph (3)(ii), an individual or entity will only be included on the
preclusion list after the expiration of either of the following:''.
++ New Sec. 422.222(a)(3)(i)(A) would state: ``If the individual
or entity does not file a reconsideration request under Sec.
498.5(n)(1) of this chapter, the individual or entity will be added to
the preclusion list upon the expiration of the 60-day period in which
the individual or entity may request a reconsideration; or''.
++ New Sec. 422.222(a)(3)(i)(B) would state: ``If the individual
or entity files a reconsideration request under Sec. 498.5(n)(1) of
this chapter, the individual or entity will be added to the preclusion
list effective on the date on which CMS, if applicable, denies the
individual's or entity's reconsideration..''
++ New Sec. 422.222(a)(3)(ii) would state: ``An OIG excluded
individual or entity is added to the preclusion list effective on the
date of the exclusion.
++ New Sec. 422.222(a)(4) would state: ``Payment denials based
upon an individual's or entity's inclusion on the preclusion list are
not appealable by beneficiaries.''
++ New Sec. 422.222(a)(5)(i) would state: ``Except as provided in
paragraphs (a)(5)(iii) and (iv) of this section, an individual or
entity that is revoked under Sec. 424.535 of this chapter will be
included on the preclusion list for the same length of time as the
individual's or entity's reenrollment bar.''
++ New Sec. 422.222(a)(5)(ii) would state: ``Except as provided in
paragraphs (a)(5)(iii) and (iv) of this section, an individual or
entity that is not enrolled in Medicare will be included on the
preclusion list for the same length of time as the reenrollment bar
that CMS could have imposed on the individual or entity had they been
enrolled and then revoked.''
++ New Sec. 422.222(a)(5)(iii) would state: ``Except as provided
in paragraph (a)(5)(iv) of this section, an individual or entity,
regardless of whether they are or were enrolled in Medicare, that is
included on the preclusion list because of a felony conviction will
remain on the preclusion list for a 10-year period, beginning on the
date of the felony conviction, unless CMS determines that a shorter
time length of time is warranted. Factors that CMS considers in making
such a determination are: (A) The severity of the offense; (B) when the
offense occurred; and (C) any other information that CMS deems relevant
to its determination.''
++ New Sec. 422.222(a)(5)(iv) would state: ``In cases where an
individual or entity is excluded by the OIG, the individual or entity
shall remain on the preclusion list until the expiration of the CMS-
imposed preclusion list period or reinstatement by the OIG, whichever
occurs later. ''
New Sec. 422.504(g)(1)(iv) would state that the MA
organization agrees that the enrollee shall not have any financial
liability for services or items furnished to the enrollee by an MA
contracted individual or entity on the preclusion
[[Page 55036]]
list, as defined in Sec. 422.2 and as described in Sec. 422.222.
We would revise the definition of ``preclusion list'' in
Sec. 423.100 as follows:
++ Revised paragraph (1)(i) of the definition would state: ``The
prescriber is currently revoked from Medicare for a reason other than
that stated in Sec. 424.535(a)(3) of this chapter.''
++ Revised paragraph (2)(i) of the definition would state: ``The
prescriber has engaged in behavior, other than that described in Sec.
424.535(a)(3) of this chapter, for which CMS could have revoked the
prescriber to the extent applicable had the prescriber been enrolled in
Medicare.''
++ We would add the word ``or'' to the end of paragraph (2)(ii)(C)
of the definition.
++ New paragraph (3) would state: ``The prescriber, regardless of
whether the prescriber is or was enrolled in Medicare, has been
convicted of a felony under federal or state law within the previous 10
years that CMS deems detrimental to the best interests of the Medicare
program. Factors that CMS considers in making such a determination
under this paragraph are: (i) The severity of the offense; (ii) when
the offense occurred; and (iii) any other information that CMS deems
relevant to its determination.''
We would revise Sec. 423.120(c)(6) as follows:
++ In paragraphs (c)(6)(i), (ii), and (vi), we would change the
term ``individual'' to ``prescriber.''
++ In paragraph (iii), we would change the phrase ``individual NPI
of the prescriber'' to ``NPI of the prescriber''.
++ A new opening paragraph of (c)(6)(iv) would state: ``With
respect to Part D prescribers that have been added to an updated
preclusion list, the Part D plan sponsor must do all of the
following:''
++ Revised paragraph (c)(6)(iv)(A) would state: ``Subject to all
other Part D rules and plan coverage requirements, and no later than 30
days after the posting of this updated preclusion list, must provide an
advance written notice to any beneficiary who has received a Part D
drug prescribed by a prescriber added to the preclusion list in this
update;''
++ Revised paragraph (c)(6)(iv)(B) would state: ``Must ensure that
reasonable efforts are made to notify the prescriber described in
paragraph (c)(6)(iv) of this section of a beneficiary who was sent a
notice under paragraph (c)(6)(iv)(A) of this section; and''
++ New paragraph (c)(6)(iv)(C) would state: ``Must not reject a
pharmacy claim or deny a beneficiary request for reimbursement for a
Part D drug prescribed by the prescriber, solely on the ground that
they have been included in the updated preclusion list, in the 60-day
period after the date it sent the notice described in paragraph
(c)(6)(iv)(A) of this section.''
++ New Sec. 423.120(c)(6)(v)(A) would state: ``CMS sends written
notice to the prescriber via letter of their inclusion on the
preclusion list. The notice must contain the reason for the inclusion
on the preclusion list and inform the prescriber of their appeal
rights. A prescriber may appeal their inclusion on the preclusion list
under this section in accordance with part 498 of this chapter.''
++ New Sec. 423.120(c)(6)(v)(B) would state: ``If the prescriber's
inclusion on the preclusion list is based on a contemporaneous Medicare
revocation under Sec. 424.535 of this chapter:''.
++ New Sec. 423.120(c)(6)(v)(B)(1) would state: ``The notice
described in paragraph (c)(6)(v)(A) of this section must also include
notice of the revocation, the reason(s) for the revocation, and a
description of the prescriber's appeal rights concerning the
revocation.''
++ New Sec. 423.120(c)(6)(v)(B)(2) would state: ``The appeals of
the prescriber's inclusion on the preclusion list and the prescriber's
revocation shall be filed jointly by the prescriber and, as applicable,
considered jointly by CMS under part 498 of this chapter.''
++ New Sec. 423.120(c)(6)(v)(C)(1) would state: ``Except as
provided in paragraph (c)(6)(v)(C)(2), a prescriber will only be
included on the preclusion list after the expiration of either of the
following:''.
++ New Sec. 423.120(c)(6)(v)(C)(1)(i) would state: ``If the
prescriber does not file a reconsideration request under Sec.
498.5(n)(1) of this chapter, the prescriber will be added to the
preclusion list upon the expiration of the 60-day period in which the
prescriber may request a reconsideration; or''.
++ New Sec. 423.120(c)(6)(v)(C)(1)(ii) would state: ``If the
prescriber files a reconsideration request under Sec. 498.5(n)(1) of
this chapter, the prescriber will be added to the preclusion list
effective on the date on which CMS, if applicable, denies the
prescriber's reconsideration.
++ New Sec. 423.120(c)(6)(v)(C)(2) would state: ``An OIG excluded
prescriber is added to the preclusion list effective on the date of the
exclusion.''
++ New Sec. 423.120(c)(6)(vii)(A) would state: ``Except as
provided in paragraphs (c)(6)(vii)(C) and (D) of this section, a
prescriber who is revoked under Sec. 424.535 of this chapter will be
included on the preclusion list for the same length of time as the
prescriber's reenrollment bar.''
++ New Sec. 423.120(c)(6)(vii)(B) would state: ``Except as
provided in paragraphs (c)(6)(vii)(C) and (D) of this section, a
prescriber who is not enrolled in Medicare will be included on the
preclusion list for the same length of time as the reenrollment bar
that CMS could have imposed on the prescriber had the prescriber been
enrolled and then revoked.''
++ Section 423.120(c)(6)(vii)(C) would state: ``Except as provided
in paragraph (c)(6)(vii)(D) of this section, a prescriber, regardless
of whether the prescriber is or was enrolled in Medicare, that is
included on the preclusion list because of a felony conviction will
remain on the preclusion list for a 10-year period, beginning on the
date of the felony conviction, unless CMS determines that a shorter
length of time is warranted. Factors that CMS considers in making such
a determination are: (1) The severity of the offense; (2) when the
offense occurred; and (3) any other information that CMS deems relevant
to its determination.''
++ Section 423.120(c)(6)(vii)(D) would state: ``In cases where a
prescriber is excluded by the OIG, the prescriber shall remain on the
preclusion list until the expiration of the CMS-imposed preclusion list
period or reinstatement by the OIG, whichever occurs later.
++ New paragraph (c)(6)(viii) would state: ``Payment denials under
paragraph (c)(6) that are based upon the prescriber's inclusion on the
preclusion list are not appealable by beneficiaries.''
We propose to revise 42 CFR part 498 as follows:
++ New Sec. 498.5(n)(1)(i) would state: ``Any individual or entity
that is dissatisfied with an initial determination or revised initial
determination that they are to be included on the preclusion list (as
defined in Sec. 422.2 or Sec. 423.100 of this chapter) may request a
reconsideration in accordance with Sec. 498.22(a).''
++ New Sec. 498.5(n)(1)(ii)(A) would state: ``If the individual's
or entity's inclusion on the preclusion list is based on a Medicare
revocation under Sec. 424.535 of this chapter and the individual or
entity receives contemporaneous notice of both actions, the individual
or entity may request a joint reconsideration of both the preclusion
list inclusion and the revocation in accordance with Sec. 498.22(a).''
[[Page 55037]]
++ New Sec. 498.5(n)(1)(ii)(B) would state: ``The individual or
entity may not submit separate reconsideration requests under paragraph
(n)(1)(ii)(A) of this section for inclusion on the preclusion list or a
revocation if the individual or entity received contemporaneous notice
of both actions.''
2. Medicare Advantage Risk Adjustment Data Validation Provisions
(Sec. Sec. 422.300, 422.310(e), and 422.311(a))
a. Background
Subpart G of the MA regulations at part 422 describes how payment
is made to MA organizations. These payment principles are based on
sections 1853, 1854, and 1858 of the Act. Subpart G also sets forth the
requirements for making payments to MA organizations offering local and
regional MA plans, including calculation of MA capitation rates.
Section 1853(a)(3) of the Act requires that we risk adjust our
payments to MA organizations. Risk adjustment strengthens the Medicare
program by ensuring that accurate payments are made to MA organizations
based on the health status plus demographic characteristics of their
enrolled beneficiaries and ensures that MA organizations are paid
appropriately for their plan enrollees (that is, less for healthier
enrollees expected to incur lower health care costs and more for less
healthy enrollees expected to incur higher health care costs). Accurate
payments to MA organizations also help ensure that providers are paid
appropriately for the services they provide to MA beneficiaries. In
general, the current risk adjustment methodology relies on enrollee
diagnoses and encounters, as specified by the International
Classification of Disease, currently the Tenth Revision Clinical
Modification guidelines (ICD-10-CM), to prospectively adjust capitation
payments for a given enrollee based on the health status of the
enrollee. Diagnosis codes determine the risk scores, which in turn
determine the risk-adjusted payments. As a result, MA organizations and
providers must focus attention on complete, truthful, and accurate
diagnosis reporting according to the official ICD-10-CM coding
guidelines.
As the ICD-10-CM guidelines emphasize, ``accurate coding cannot be
achieved'' without ``consistent, complete documentation in the medical
record.'' Diagnoses submitted for payment by MA organizations must be
supported by medical record documentation. This requirement has been in
place since the beginning of the MA program. It has been explained in
every edition of the Medicare Managed Care Manual, with which MA
organizations agree to comply as a condition of their participation.
(See the 2013 Medicare Managed Care Manual, Sec. 40; 2004 Medicare
Managed Care Manual, Sec. 111.1, Ex. 30 & Sec. 111.4; 2001 Medicare
Managed Care Manual, Sec. 110.4.) It has also been emphasized in
numerous trainings provided to MA organizations and their
subcontractors.
The diagnosis data submitted by MA organizations must conform to
all relevant national standards. (See 42 CFR 422.310(d)(1).) As
discussed earlier, the Clinical Modification of the International
Classification of Disease, published by the federal government, is the
chief national standard for diagnosis coding. It is the coding system
on which MA risk adjustment is run. Medical record documentation is a
core principle of the ICD-10-CM diagnosis coding system and was equally
central to the Ninth Revision (ICD-9-CM), which preceded it. A federal
court of appeals has recognized the requirement of medical record
documentation for diagnosis codes submitted for payment by MA
organizations. United States ex rel. Swoben v. United Health Ins. Co.,
848 F.3d 1161, 1168, 1176 (9th Cir. 2016). When MA organizations
certify that their diagnosis codes are ``accurate'' and ``truthful'' to
the ``best knowledge, information, and belief'' of the certifying
individual, the existence of adequate medical record documentation is
one important standard by which accuracy and truthfulness are measured
(42 CFR 422.504(l)(1)). As we have previously explained, our ``risk
adjustment methodology provides that a specific amount be paid if an
enrollee has a particular condition'' (75 FR 19745). The medical record
documentation requirement is ``designed to ensure that the enrollee in
fact has th[e] condition'' for which an MA organization is requesting
payment under the risk adjustment model (75 FR 19745).
The current risk adjustment model employed in adjusting MA plan
payments is known as the CMS Hierarchical Condition Category (CMS-HCC)
model. It functions by categorizing ICD-10-CM codes into disease groups
called Hierarchical Condition Categories, or HCCs. Each HCC includes
diagnosis codes that are related clinically and have similar cost
implications. The CMS-HCC model is recalibrated approximately every 2
years to reflect newer treatment and coding patterns in Medicare FFS.
This recalibration is made through the annual advance notice of
methodological changes authorized by 42 U.S.C. 1395w-23(b)(2). Since
2007, when a demographic data-only payment method was completely
phased-out for MA plans, 100 percent of payment has been risk-adjusted.
The statute continues to provide us the authority to add to, modify, or
substitute for risk adjustment factors if the changes will improve the
determination of actuarial equivalence.
b. Risk Adjustment Data Validation Initiatives
MA enrollee HCCs are assigned based on data submitted to us by MA
organizations via the Risk Adjustment Payment System (RAPS) and
Encounter Data System (EDS). The HCCs contribute to an enrollee's risk
score, which is used to adjust a base payment rate. Essentially, the
higher the risk score for an enrollee, the higher the expected health
care cost for the enrollee. The HCC data that MA organizations submit
to CMS via the RAPS and EDS systems is self-reported by the MA
organization and does not go through a validation review before being
incorporated into a given beneficiary's risk-profile. Since there is an
incentive for MA organizations to potentially over-report diagnoses so
that they can increase their payment, the Department audits plan-
submitted diagnosis data a few years later to ensure they are supported
by medical record documentation.
Verifiable medical record documentation is key to accurate payment
and successful data validation. We annually select MA organizations for
risk adjustment data validation (RADV) audits.\23\ RADV audits are
intended to confirm the presence of risk adjustment conditions (that
is, diagnoses that map to HCCs) as reported by MA organizations for
their enrollees and confirmed via medical record documentation. RADV
audits occur after the final risk adjustment data submission deadline
for the MA contract year. The audits validate the HCC data submitted by
MA organizations by reviewing hospital inpatient, hospital outpatient,
and physician/practitioner provider medical records. The focus of this
medical record review activity is on diagnoses related to the
enrollee's HCC profile. Risk adjustment discrepancies are identified
when the enrollee's HCCs used for payment (based upon MA organization-
submitted data) differ from the HCCs assigned based on the medical
record, pursuant to the RADV audit
[[Page 55038]]
process. Risk adjustment discrepancies can be aggregated to determine
an overall level of payment error. In turn, payment error for a sample
of contract enrollees can be extrapolated to calculate a contract-level
payment error estimate. Although we have the authority to extrapolate
from a statistically valid sample to calculate a contract-level audit
recovery, we have not yet done so.
---------------------------------------------------------------------------
\23\ Any changes to the CMS-HCC payment model are published in
the annual payment notice.
---------------------------------------------------------------------------
From 1999 until 2003, our payment validation activity for the MA
program had both an educational and audit focus and was intended to
improve the accuracy of the risk adjustment data that was being
submitted to CMS for payment. Payment adjustments were limited to
enrollee-level adjustments for those enrollees sampled in the payment
validation audit. At the time, only 10 percent of the MA payment amount
was risk adjusted. As a result, payment recovery amounts for the small
number of plans audited was very small. Since payment year 2004 was the
first year for which MA payments were based on the current HCC risk
adjustment model, we considered payment years 2004 through 2006 as
pilot years for the purpose of RADV and no payment recovery activity
occurred.
Payment recovery resumed for payment year 2007, when we audited 37
MA contracts and recouped $13.7 million. Payment adjustments were again
limited to enrollee-level adjustments for those enrollees sampled in
the payment validation audit. (Although we suggested that we would make
contract-level payment adjustments for the payment year 2007 audits, we
did not ultimately do so.) In the course of that audit process, as in
previous years, we reviewed medical record documentation provided by
each audited MA organization to substantiate conditions reported by the
organization for beneficiaries in each audit sample. After CMS'
findings were reported to each MA organization, any organization that
disagreed with CMS' determinations could challenge them through a
three-stage administrative process established by regulation in 2010.
(See 42 CFR 422.311). This dispute and appeals process is currently
ongoing.
No payment validation audits were conducted for payment years 2008,
2009, or 2010. In those years, we were considering the development of a
methodology for calculating payment adjustments based on statistical
RADV MA contract-level payment error audit findings. The development of
contract-level RADV audits would enable us to make contract-level
payment adjustments rather than simply adjusting payments for specific
enrollees from an audit sample, as we had done previously.
On December 20, 2010, we proposed a methodology on the CMS website
for selecting a statistically-valid sample of enrollees from each
audited MA contract and extrapolating from the results of that sample
audit to calculate a contract-level payment adjustment. We invited
public comment on this proposed methodology, and received more than 500
comments, which we carefully reviewed. On February 24, 2012, we
published what we described as the final methodology for RADV contract-
level payment error calculation.\24\ That methodology described
sampling techniques and the statistical calculation to be used to
extrapolate from the sample selected. In brief, up to 201 enrollees
from each audited MA contract would be selected according to certain
criteria, including their continuous enrollment in the contract for the
entire data collection year and January of the payment year; their lack
of end-stage renal disease (ESRD) status and hospice status for that
entire period; their enrollment in Medicare Part B coverage for the
entire data collection year; and their submission of at least one
diagnosis during the data collection year leading to at least one CMS-
HCC assignment in the payment year. The RADV-eligible enrollees would
be ranked by risk score and then divided into three equal strata. An
equal number of enrollees would then be randomly selected from each
stratum (67 enrollees per stratum in the case of an audit of 201
enrollees). After medical records were reviewed, payment errors would
be calculated for each selected enrollee based on the number of months
the person was enrolled in the selected MA contract (and was not in
ESRD or hospice status) during the payment year. A payment error rate
for each stratum would be calculated, and then an overall payment error
rate for the audited contract, computed at a ninety-nine percent
confidence interval. We stated that this methodology would be applied
to the next round of RADV audits, which would be conducted on payment
year 2011. Audits for payment years 2011, 2012, and 2013 have been
conducted according to this methodology, at a total cost of
approximately $150 million to the agency, but have not yet been
finalized. These audits are in addition to RADV and related MA audits
conducted by the Office of Inspector General, which are conducted
pursuant to OIG's independent authorities at sections 2(1) and 4(a)(1)
of the Inspector General Act.
---------------------------------------------------------------------------
\24\ Notice of Final Payment Error Calculation Methodology for
Part C Medicare Advantage Risk Adjustment Data Validation Contract-
Level Audits, available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/recovery-audit-program-parts-c-and-d/Other-Content-Types/RADV-Docs/RADV-Methodology.pdf.
---------------------------------------------------------------------------
We also stated in 2012 that, after using this methodology to
calculate a preliminary payment recovery amount, we would apply a FFS
Adjuster as an offset before finalizing the audit recovery. The FFS
Adjuster was intended to account for any effect of erroneous diagnosis
codes in the data from Medicare Parts A and B (often referred to as
``Fee-For-Service'' Medicare) that are used to calibrate the MA risk
adjustment model. We stated that the FFS Adjuster would calculate a
permissible level of payment error (for example, a percentage of the
total payments made on an MA contract in a given year) and limit RADV
audit recovery to payment errors above that level. The FFS Adjuster was
never intended to set a permissible rate for the submission of
erroneous diagnosis codes. We stated that the FFS Adjuster would be
calculated based on a RADV-like review of records submitted to support
the Medicare Part A and B diagnosis codes. That review is now complete,
and will be discussed later.
c. Discussion of Proposals
(1) Extrapolation
The Secretary intends to recover overpayments based on extrapolated
audit findings through the use of statistically valid random sampling
techniques. Although we described our February 2012 publication as the
final methodology to be used to calculate contract-level RADV audit
recoveries for payment year 2011, it has never been implemented. As we
stated earlier, audits for payment years 2011, 2012, and 2013 have been
conducted according to this methodology, but contract-level recoveries
have not yet been sought. We are now providing additional notice and
again welcoming public input on the agency's methodology for
calculating a contract-level payment error in RADV audits, including
the sample sizes used in these contract-level audits. CMS is not
required to set forth the methodology for calculating an extrapolated
payment error through regulatory provisions (it does not do so in Parts
A and B, where Medicare Administrative Contractors (MACs) may use any
statistically valid sampling and extrapolation methodology they
determine to be appropriate), however, in the interest of transparency,
we are updating
[[Page 55039]]
stakeholders on our plans to use various sampling and extrapolation
methodologies in RADV audits, as CMS deems appropriate.\25\ All audits
will be based on statistically valid sampling and extrapolation
methodologies.
---------------------------------------------------------------------------
\25\ The Office of the Inspector General, which is required by
law to conduct audits and follow generally accepted government
auditing standards, does not seek comment on its methodology for
risk adjustment audit work that may lead to overpayment recoveries
from MA organizations.
---------------------------------------------------------------------------
In addition to the contract-level methodology described earlier, we
have identified other potential methodologies for sampling and
extrapolation, which would calculate improper payments made on the
audited MA contract for a particular sub-cohort or sub-cohorts in a
given payment year, and the agency may also use such a methodology to
calculate improper payments made to the audited MA contract. For
example, a sub-cohort could be the enrollees for whom a particular HCC
or one of a related set of HCCs (such as the three diabetes HCCs) was
reported. After choosing an MA contract and a sub-cohort or sub-cohorts
to audit, we would select a statistically significant sample of
enrollees for the sub-cohort or sub-cohorts. After reviewing the
medical records of those enrollees, we would use statistical
extrapolation to calculate and recoup the improper payments made to the
audited MA contract for covering enrollees for the sub-cohort or sub-
cohorts in that payment year. We would use the same statistical
calculation for this sub-cohort-level extrapolation as we do for the
contract-level extrapolation (although we welcome comment as to whether
to stratify the sample population for the sub-cohort audits, as we
currently anticipate doing for the contract-level audits).
We believe that, because any sub-cohort is necessarily a subset of
the enrollees covered through a particular MA contract, we could often
use a much smaller sample size to calculate a statistically significant
extrapolated recovery for a sub-cohort than would be required to
calculate a contract-level recovery (up to 201 enrollees, according to
our anticipated contract-level methodology). This smaller sample size
would allow us to spread our audit resources across a wider range of MA
contracts, while still generating statistically significant recoveries.
This sub-cohort-based audit methodology would allow us to focus on
cohorts of enrollees that appear to raise programmatic concerns.
We invite comment on both the contract-level audit methodology
published in February 2012, and our proposal for an extrapolated audit
methodology based on sub-cohorts of enrollees. We also seek comment on
whether there are particular situations in which one methodology may be
preferable to the other, and whether the agency should revise the
contract-level audits that have been conducted but not finalized for
payment years 2011, 2012, and 2013. Neither proposed methodology is
meant to displace our longstanding authority to audit the medical
records of particular enrollees who we believe may be associated with
improper payments or to use any statistically valid audit
methodology.\26\
---------------------------------------------------------------------------
\26\ We may begin to conduct RADV audits for payment years 2014
and 2015 before this proposal is finalized, pursuant to our
longstanding authority to review the medical records of any MA
enrollee and recoup any improper payments identified. Although we
would design these audits so that the individuals selected would
form a statistically significant sample that would support an
extrapolated recovery, we would not seek to recover on an
extrapolated basis until the rule is final. At the very least, these
audits would support enrollee-level recoveries.
---------------------------------------------------------------------------
If we finalize one or more sampling and extrapolation methodologies
through this rulemaking, we would make any future changes to that
methodology (or those methodologies) through the Health Plan Management
System.
We are also considering whether to explicitly expand the MA
organizations' RADV appeal rights, particularly in light of the
upcoming auditing and recoveries in the MA program. One option would be
to permit appeal of the RADV payment error calculation methodology used
in a RADV audit similar to practices in the Part A and Part B space of
Medicare FFS. We invite comments on this matter.
(2) Application to Payment Year 2011 and Subsequent Years
We intend to apply the finalized RADV payment error methodology or
methodologies to payment year 2011, and all subsequent years. (However,
we do not expect to use a sub-cohort-based methodology, if finalized,
for any payment year before 2014). Section 1871(e)(1)(A) of the Act
authorizes retroactive application of rules where ``(i) such
retroactive application is necessary to comply with statutory
requirements; or (ii) failure to apply the change would be contrary to
the public interest.'' We are considering whether application of the
finalized methodology or methodologies to payment year 2011, and all
subsequent years, would require the exercise of this statutory
authority to engage in retroactive rulemaking. We invite comment on the
subject.
In any case, we believe that failure to apply the finalized RADV
payment error methodology or methodologies to those payment years would
be contrary to the public interest. The public has a substantial
interest in the recoupment of millions of dollars of public money
improperly paid to private insurers. The public also has a significant
interest in providing incentives for those insurers to claim only
proper payments in the future, which would be promoted by the
recoupment of funds improperly paid in the past. Given the amount of
improper payments identified under the MA program (estimated to be
$14.35 billion in FY 2017,\27\ the $650 million in recovered improper
payments represents, if this policy was finalized, 3 years improper
payment for 30 plans), the interest in determining an accurate recovery
amount for each audited MA plan, and the importance of protecting the
overall integrity of the program, we believe that it is in the public
interest for CMS to apply the RADV payment error methodology or
methodologies adopted through this rulemaking to payment year 2011 and
all subsequent years. In applying this methodology (or these
methodologies) to those payment years, CMS would be acting in
compliance with the IPERIA statute \28\ as
[[Page 55040]]
well as its own fiduciary responsibility to recover funds due and owing
to the Medicare Trust Funds. We note also that our February 2012
publication put MA organizations on notice that CMS expected to
calculate a contract-level payment error for payment year 2011 and
beyond by extrapolating from its review of a statistically valid sample
of enrollees, and that (as explained earlier) MA organizations have
never been entitled to receive or retain payments associated with HCCs
that cannot be validated by medical records. Application of the
finalized RADV payment error methodology or methodologies to payment
year 2011 and all subsequent years therefore would not upset any
settled interest.
---------------------------------------------------------------------------
\27\ CMS has historically reported high levels of payment error
in the Part C program. The Part C error rate has ranged between 11
percent and 9 percent between fiscal years (FY) 2011 and 2014,
respectively. In FY 2017, the reported Part C error rate was 8.31
percent or $14.35 billion.
\28\ Improper Payments Elimination and Recovery Improvement Act
of 2012 (IPERIA, Pub. L. 112-248). The RADV program is a corrective
audit activity developed by CMS to address provisions included in
the IPIA of 2002, as amended by the IPERA of 2010, and further
amended by IPERIA. These statutes require that government agencies
annually estimate and report improper payments. RADV audits were
initiated because Part C payment error was out of compliance with
IPIA. The IPERIA requires the Office of Management and Budget (OMB)
to annually identify agencies for greater levels of oversight and
review, and with that agency ``establish annual targets and semi-
annual or quarterly actions for reducing improper payments
associated with each high-priority program.'' In November 2009,
Executive Order (E.O.) 13520 was signed in an effort to reduce
improper payments by increasing transparency in government and
holding agencies accountable for reducing improper payments. In
March 2010, OMB issued guidance for agencies regarding the
implementation of E.O. 13520 entitled Part III to OMB Circular A-
123, Appendix C (Appendix C). Appendix C outlines the
responsibilities of agencies, determines the programs subject to
E.O. 13520, defines supplemental measures and targets for high
priority programs, and establishes reporting requirements under E.O.
13520 and procedures to identify entities with outstanding payments.
One of those remedies is payment recapture audits, a requirement
that any program that expends at least $1 million must implement
payment recapture audits. A recovery audit, or payment recapture
audit, is a review process designed to identify erroneous payments.
Additionally, it is a corrective control activity designed to
identify and recapture erroneous payments, and, as such, is a
management function and responsibility.
---------------------------------------------------------------------------
If the finalized contract-level audit methodology differs from the
one we published in February 2012, we will also consider whether to
apply the new contract-level payment error methodology to payment years
2011, 2012, and 2013, or to only apply it to payment year 2014 and
subsequent years, and to finalize the audits for those earlier payment
years according to the methodology published in February 2012. We
invite comment on this subject, as well. In any event, and however
audits for prior years are ultimately handled, we believe that it is
vitally important for the health of the MA program to have extrapolated
recoveries available for future audit years.
(3) Implementation
This proposal would announce CMS' intention to recover improper
payments based on extrapolation of payment error from RADV audit
samples to MA organization specified populations. CMS would calculate
and recover improper payments based on extrapolation methodologies. MA
organizations would be required to remit extrapolated recovery amounts
from audit findings as calculated by CMS through its payment system,
Medicare Advantage and Prescription Drug system (MARx). MARx is the CMS
system that makes monthly payments and payment adjustments to the MA
organizations and Part D sponsors. Overpayment recoveries of all types
are considered payment adjustments which are done as offsets to the
plans' monthly payments. RADV recovery amounts are included in this
category. In the month the plan has been notified that the recovery
amount will be offset, the MARx system makes an offset to the plans
monthly payment equal to the amount of the recovery amount. In the
event the recovery amount exceeds the payment in 1 month, the recovery
will be spread across adjustments for multiple months until the full
amount is recovered. CMS may likewise require MA organizations to remit
such recovery amounts based upon audit findings by OIG.
(4) Recoupment of Improper Payments in Part C
Improper payments identified by CMS outside of the RADV audit
process or self-identified by the MA organization that are not returned
in accordance with Sec. Sec. 422.330, and are identified and/or
estimated through extrapolation or other estimation methodologies as a
result of CMS audits will be recovered following CMS audit processes
including payment offset. We propose that MA organizations be required
to remit funds that CMS calculates as improper payments through the
extrapolated RADV audit findings in accordance with Sec. Sec.
422.310(e). RADV audit results can be appealed by MA organizations
using the regulatory administrative appeals process outlined in Sec.
422.311.
(5) FFS Adjuster
After our 2012 RADV publication, we conducted an extensive study
regarding the presence and impact of diagnosis error in FFS claims
data. Our study suggests that errors in FFS claims data do not have any
systematic effect on the risk scores calculated by the CMS-HCC risk
adjustment model, and therefore do not have any systematic effect on
the payments made to MA organizations.\29\
---------------------------------------------------------------------------
\29\ We are aware of the district court's recent ruling in
United HealthCare Insurance Co. v. Azar, No. 16-cv-157 (D.D.C.
September 7, 2018), and the government is reviewing that decision
and considering its response. In any event, that ruling was made on
the basis of the administrative record before the court, which did
not include the results of our study.
---------------------------------------------------------------------------
The study began by auditing 8,630 outpatient claims paid through
Medicare Part B in a given year. We reviewed the medical records
associated with each claim (a small subset of the medical records
associated with each beneficiary) to determine whether the diagnosis
associated with the claim was supported by medical record
documentation. A discrepancy rate for each CMS-HCC was then calculated.
For example, the data set contained 484 claims submitted with a
diagnosis of chronic obstructive pulmonary disease, which is CMS-HCC
108. Of those diagnoses, 388 were supported by medical record
documentation, and 96 were not, for a discrepancy rate of 19.8 percent.
To account for the fact that the data set contained extremely small
samples of many CMS-HCCs--for example, one diagnosis of extensive third
degree burns and two diagnoses of severe head injury--we calculated a
high, low, and baseline discrepancy rate. Each CMS-HCC was assigned one
of these three mean discrepancy rates depending on its relationship to
the bassline discrepancy rate: CMS-HCCs with a discrepancy rate
significantly higher than the baseline were assigned to the high
category, and those with a discrepancy rate significantly lower than
the baseline were assigned to the low category. All other CMS-HCCs were
assigned the baseline discrepancy rate. These rates were 46.2 percent,
33.8 percent, and 20.9 percent.
In a given year, multiple claims are submitted for Medicare Part B
services received by a given beneficiary and associated with a given
diagnosis. For example, an average beneficiary with metastatic cancer
or acute leukemia, which is CMS-HCC 7, has seven claims associated with
that diagnosis. Because we were interested in determining whether a
given beneficiary had a documented diagnosis in a given year, and not
whether any particular claim was associated with medical record
documentation, we used the claim-level discrepancy rates described
above to calculate beneficiary-level discrepancy rates.\30\
---------------------------------------------------------------------------
\30\ For example, metastatic cancer or acute leukemia was
assigned the baseline discrepancy rate of 33.8%. We therefore
reasoned that each of the seven claims associated with the average
beneficiary for whom such a diagnosis was reported had a 66.2%
chance of being supported by medical record documentation, and only
one instance of medical record support was necessary to make the
diagnosis valid for that year. If each beneficiary with such a
reported diagnosis has 7 claims associated with that diagnosis, and
each claim has a 66.2% chance of being supported by medical record
documentation, then 99.95% of all beneficiaries will have at least
one instance of medical record support, and only 0.05% of
beneficiaries will lack any medical record documentation of their
reported diagnosis.
---------------------------------------------------------------------------
After calculating this beneficiary-level discrepancy rate for each
HCC, we ran fifty simulations in which we removed diagnoses from a data
set of more than 1.4 million Medicare Part A and B beneficiaries at the
beneficiary-level discrepancy rate.\31\ After removing diagnoses at the
indicated rates, we used each simulated ``corrected'' data set to
recalibrate the CMS-HCC risk adjustment model, applied the recalibrated
risk coefficients to a data set of MA beneficiaries, and compared their
original risk scores to the risk
[[Page 55041]]
scores calculated with the recalibrated model. We found that the
difference between the risk scores was very small, and that the
recalibrated risk scores tended to be slightly lower than the original
risk scores. Therefore, we concluded that diagnosis error in FFS claims
data does not lead to systematic payment error in the MA program.
---------------------------------------------------------------------------
\31\ For metastatic cancer and acute leukemia, 1 in 2,000
diagnoses was removed (corresponding to an error rate of 0.05%).
---------------------------------------------------------------------------
An executive summary of the findings and a technical appendix
describing the data and methodology can be found at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-Risk-Adjustment-Data-Validation-Program/Resources.html.
Because it appears that diagnosis error in FFS claims data does not
lead to systematic payment error in the MA program, we propose not to
include an FFS Adjuster in any final RADV payment error methodology.
Moreover, even if we had found that diagnosis error in FFS claims
data led to systematic payment error in the MA program, we no longer
believe that a RADV-specific payment adjustment would be appropriate.
RADV audits are used to recover payments based on diagnoses that are
not supported by medical record documentation, which thus should not
have been reported to CMS. If a payment has been made to an MA
organization based on a diagnosis code that is not supported by medical
record documentation, that entire payment is in error and should be
recovered in full, because the payment standard has not been met, and
the MA organization is not entitled to any payment for that diagnosis.
RADV audits do not address issues with the accuracy of payments based
on diagnosis codes that are supported by medical record documentation.
Consequently, an adjustment to RADV recoveries to remedy payment
accuracy concerns is inappropriate. For this reason, we believe that it
would not be appropriate to correct any systematic payment error in the
MA program through a payment adjustment that was only applied to
audited contracts. Doing so would introduce inequities between audited
and unaudited plans, by only correcting the payments made to audited
plans.
Because our study suggests that diagnosis error in FFS claims data
does not lead to systematic payment error in the MA program and because
we believe it would be inequitable to correct any systematic errors in
the payments made to audited plans only, we would not include an FFS
Adjuster in any RADV extrapolated audit methodology. We welcome public
comments on this study.
d. Proposed Changes
In this section, we discuss the proposed changes to the regulation
in Parts 422 and 423 governing the MA Program. We are proposing to
apply extrapolation to plan year audits for payment year 2011 forward.
The following is a summary of the proposed changes included in this
proposed revision:
We propose to revise Sec. 422.300 to include ``collection of
improper payments.''
We propose to amend Sec. 422.310(e) Validation of risk adjustment
data, to apply extrapolation to plan year audits for payment year 2011
forward.
We propose to amend Sec. 422.310(e) Validation of risk adjustment
data, by adding a requirement to set forth the provision for MA
organizations to remit improper payments based on RADV audits and
established in accordance with stated methodology, in a manner
specified by CMS.
We propose to amend Sec. 422.311, the RADV audit dispute and
appeal process section, by adding language to clarify that recovery of
improper payments from MA organizations will be conducted according to
the Secretary's payment error extrapolation and recovery methodologies
and that CMS will apply extrapolation to plan year audits for payment
year 2011 forward.
D. Implementing Other Changes
1. Clarification Regarding Accreditation for Quality Improvement
Programs
Section 1852(e) of the Act requires each MA organization to have an
ongoing quality improvement program to improve the quality of care
provided to its enrollees and establishes the requirements for the
quality improvement programs. Section 1852(e) (4) of the Act requires
the Secretary to deem that an MA Organization has met all of the
requirements for any one out of the six program areas listed in section
1852(e)(4)(B) of the Act if the MA Organization is accredited in that
area by an accrediting organization that has been approved by CMS and
that uses the same (or stricter) standards than CMS uses to evaluate
compliance with the applicable requirements. Section 1852(e)(4)(B)(i)
of the Act references the quality improvement programs in section
1852(e) of the Act. Thus, an MA Organization could be deemed to meet
CMS' requirements related to quality improvement programs by a CMS-
approved accrediting organization.
Section 722(a) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (the MMA) revised the quality improvement
program requirements in the Act. Section 1852(e) of the Act was revised
by adding a new clause ``(2) Chronic Care Improvement Programs'' and
renumbering the existing clauses accordingly (that is, existing clause
``(2) Data'' became ``(3) Data''). Section 722(a) of the MMA also
revised section 1852(e)(4)(B)(i) of the Act. Prior to the MMA, section
1852(e)(4)(B)(i) of the Act indicated that the requirements in clauses
(e)(1) (general requirements for quality improvement programs) and
(e)(2) (the collection, analysis, and reporting of data related to
quality improvement programs) could be deemed. Consistent with the
changes made to section 1852(e) of the Act described earlier, section
722(a) of the MMA amended section 1852(e)(4)(B)(i) of the Act to
provide, ``(i) Paragraphs (1) through (3) of this subsection (relating
to quality improvement programs).'' However, the printed and online
versions of section 1852(e)(4)(B)(i) of the Act continue to cross-
reference clauses (e)(1) and (e)(2) erroneously. Therefore, we are
clarifying in this proposed rule that the requirements in section
1852(e)(3) of the Act and the subsections of Sec. 422.152 related to
section 1852(e)(3) of the Act may be deemed.
2. Delete the Reference to Quality Improvement Projects in Sec.
422.156(b)(1)
Section 1852(e) of the Act requires each MAO to have an ongoing
Quality Improvement (QI) Program for the purpose of improving the
quality of care provided to its enrollees. Our regulations at Sec.
422.152 outline the QI Program requirements MA Organizations. Section
422.152(a)(3) requires each MA Organization to conduct quality
improvement projects (QIPs) for its enrollees, and Sec. 422.152(d)
establishes the requirements for the QIPs. Effective January 1, 2019,
CMS eliminated the requirements for QIPs in Sec. Sec. 422.152(a)(3)
and 422.152(d) in the April 2018 final rule (83 FR 16440). However, the
reference to QIPs was not deleted in Sec. 422.156(b)(1), which says
QIPs are exempt from the process for deeming compliance based on
accreditation. Therefore, we are proposing a technical correction in
this rule that would delete the phrase ``the quality improvement
projects (QIPs) and'' from Sec. 422.156(b)(1).
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et
seq.), we are required to provide 60-day notice in the Federal Register
and solicit public comment before a collection of
[[Page 55042]]
information requirement is submitted to the Office of Management and
Budget (OMB) for review and approval. In order to fairly evaluate
whether an information collection should be approved by OMB, section
3506(c)(2)(A) of the PRA 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 estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
In this proposed rule, we are soliciting public comment on each of
these issues for the following sections of this rule that contain
proposed ``collection of information'' requirements as defined under 5
CFR 1320.3 of the PRA's implementing regulations.
A. Wage Data
To derive average costs for the private sector, we used data from
the U.S. Bureau of Labor Statistics' (BLS's) May 2017 National
Occupational Employment and Wage Estimates for all salary estimates
(http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 2
presents the mean hourly wage, the cost of fringe benefits and overhead
(calculated at 100 percent of salary), and the adjusted hourly wage.
[GRAPHIC] [TIFF OMITTED] TP01NO18.005
As indicated, we are adjusting our employee hourly wage estimates
by a factor of 100 percent. This is necessarily a rough adjustment,
both because fringe benefits and overhead costs vary significantly from
employer to employer, and because methods of estimating these costs
vary widely from study to study. We believe that doubling the hourly
wage to estimate total cost is a reasonably accurate estimation method.
B. Proposed Information Collection Requirements (ICRs)
1. ICRs Regarding the Requirements for Medicare Advantage Plans
Offering Additional Telehealth Benefits (Sec. Sec. 422.100, 422.135,
422.252, 422.254, and 422.264)
Proposed revisions to the Evidence of Coverage (EOC) model to take
into account the new type of benefit will be submitted to OMB for
approval under control number 0938-1051 (CMS-10260).
As described in section II.A.1. of this proposed rule, section
50323 of the Bipartisan Budget Act of 2018 allows MA plans to provide
``additional telehealth benefits'' to enrollees starting in plan year
2020 and treat them as basic benefits for purposes of bid submission
and payment by CMS. In this rule, we propose to codify requirements at
Sec. 422.135, which would authorize and set standards for MA plans to
offer additional telehealth benefits.
More specifically, MA plans would be required to advise enrollees
that they may receive the specified Part B service(s) either through an
in-person visit or through electronic exchange. This notification would
appear in the EOC document, which is already required and provided in
model form by CMS to MA plans. There is a one-time cost for CMS to
formulate the required template notification language in our EOC model
for all plans to adopt without edit. Since CMS's burden to revise the
model is outside the scope of the PRA, the federal cost estimate is
scored in section IV.C.1. of this proposed rule. The revised template,
however, is subject to the PRA and will be submitted to OMB for their
review and approval.
MA plans would also be required to use their provider directory to
identify any providers offering services for additional telehealth
benefits and in-person visits or offering services exclusively for
additional telehealth benefits. Like the EOC, the provider directory is
already required and provided in model form by CMS, with MA plans
obligated to and responsible for populating the document with the
relevant information about the providers in the MA plan's contracted
network. It is difficult to assess the additional burden associated
with this requirement because the provider directory model already
requires plans whose providers may have restrictions on access to
include a notation next to the provider's listing indicating such
restrictions. We are unsure what, if any, additional burden may be
associated with this new data field and we seek information that may
inform the burden.
Finally, MA plans would be required to make information about
coverage of additional telehealth benefits available to CMS upon
request. We do not anticipate requesting this information from more
than 9 MA plans in a given year because historically we have not
received a large number of complaints about coverage of benefits that
might warrant us requesting information from many plans. However, we
would like to reserve the right to ask for this information if
necessary. Since we estimate fewer than ten respondents, the
information collection requirement is exempt (5 CFR 1320.3(c)) from the
requirements of the PRA.
2. ICRs Regarding Integration Requirements for Dual Eligible Special
Needs Plans (Sec. Sec. 422.2, 422.60, 422.102, 422.107, 422.111, and
422.752)
The following proposed requirements and burden will be submitted to
OMB for approval under control number 0938-0753 (CMS-R-267).
As described in section II.A.2.a. of this proposed rule, we propose
to establish new requirements in accordance with amendments to section
1859(f)(8) of the Act (made by section 50311(b) of the Bipartisan
Budget Act of 2018), which stipulates that all dual eligible special
needs plans (D-SNPs) meet certain new minimum criteria for Medicare and
Medicaid integration for 2021 and subsequent years. We also propose to
codify the various forms of integrated care provided by D-SNPs that
have evolved since their establishment nearly 15 years ago.
[[Page 55043]]
In Sec. 422.107(d), we propose that any D-SNP that is not a fully
integrated dual eligible special needs plan (FIDE SNP) or a highly
integrated dual eligible special needs plan (HIDE SNP), as defined in
proposed Sec. 422.2, would be subject to an additional contracting
requirement. Under the additional contracting requirement, the D-SNP
would notify the state Medicaid agency and/or individuals or entities
designated by the state Medicaid agency of hospital and skilled nursing
facility (SNF) admissions for at least one group of high-risk full-
benefit dual eligible individuals, as determined by the state Medicaid
agency.
We also propose modifications to existing requirements for the
contract between states and D-SNPs at Sec. 422.107(b) and (c). These
modifications would include requirements that D-SNPs: Document their
responsibility to provide, as applicable, or coordinate the delivery of
Medicaid benefits; specify the categories and criteria for dual
eligible individuals to be enrolled in the plan; and specify the
Medicaid benefits covered by the MA organization offering the D-SNP or
under a risk contract with a Medicaid managed care organization offered
by the D-SNP's parent organization or another entity that is owned and
controlled by its parent organization.
The primary burden arising from the proposals would consist of the
following:
Burden to the state to--
++ Execute D-SNP contract modifications; and
++ Set the terms of the notification, including its method, timing,
and scope, and for some states, receive a notification from D-SNPs
about enrollees' hospital and SNF admissions.
Burden to the D-SNP to--
++ Execute a contract modification with the state Medicaid agency;
++ Notify the state Medicaid agency or its designee(s) about
enrollees' hospital and SNF admissions.
a. Burden to States
(1) Contract Modifications With D-SNPs (Sec. 422.107)
For the initial year, we expect it would take 24 hours at $136.44/
hr for a lawyer to update the state Medicaid agency's contract with
every D-SNP in its market. Since half of the cost would be offset by
federal financial participation for Medicaid administrative activities,
we have adjusted our estimates for state agencies by 50 percent. Given
the market penetration of D-SNPs in certain states relative to others,
we recognize that this estimate reflects an average cost across all
states and territories with D-SNPs. We expect that the state Medicaid
agency would establish a uniform requirement for all D-SNPs operating
in their market. As of June 2018, there were 42 states, plus the
District of Columbia and one territory (Puerto Rico), in which D-SNPs
were available to MA enrollees. In aggregate, we estimate a one-time
first year burden of 1,056 hours (44 respondents * 24 hr/response) at a
cost of $72,040 (1,056 hr * $136.44/hr * 0.50).
While we recognize that, over time, states could modify this
contract term, for example, by expanding the population of full-benefit
dual eligible individuals to whom this notification applies, we do not
believe that such a contract change would have a material impact on
time and effort and, therefore, would already be accounted for in the
burden estimate for the overall contract that the state Medicaid agency
has with each D-SNP.
Given the lack of material impact and the uncertainty involved in
estimating state behavior, we are estimating a minimum of zero burden
in subsequent years on plans. The maximum burden would be the estimated
first year cost. However, we believe the maximum estimate is unlikely
to be accurate since we expect any changes to contracting requirements
to be iterative compared to the first year update. We solicit public
comment on our assumptions and whether there are reasonable ways of
modeling state behavior.
(2) Notification (Sec. 422.107(d))
To address differences among the states in available
infrastructure, population sizes, and mix of enrollees, this rule
proposes broad flexibility identifying the groups for which the state
Medicaid agency wishes to be notified and how the notification should
take place. Flexibilities include: (1) Consideration of certain groups
who experience hospital and SNF admissions; (2) protocols and
timeframes for the notification; (3) data sharing and automated or
manual notifications; and (4) use of a stratified approach over several
years starting at a small scale and increasing to a larger scale. We
would also allow states to determine whether to receive notifications
directly from D-SNPs or to require that D-SNPs notify a state designee
such as a Medicaid managed care organization, section 1915(c) waiver
case management entity, area agency on aging, or other organization.
Some states, using a rich infrastructure and a well-developed
automated system, may fulfill this requirement with minimal burden,
while states with less developed or no infrastructure or automated
systems may incur greater burden. Furthermore, the burden, especially
to those states starting on a small scale, may differ significantly
from year to year. Because of the flexibilities provided in this
proposed rule, we expect states to choose strategies that are within
their budget and best fit their existing or already-planned
capabilities. We would expect any state choosing to receive
notification itself of such admissions to claim federal financial
participation under Medicaid for that administrative activity.
As of June 2018, there were 42 states, plus the District of
Columbia and one territory (Puerto Rico), in which D-SNPs were
available to MA enrollees. We estimate that there are nine states and
territories with D-SNPs that all are expected to qualify as either FIDE
SNPs or HIDE SNPs--Arizona, Florida, Hawaii, Idaho, Massachusetts,
Minnesota, New Jersey, New Mexico, and Puerto Rico. We do not expect
these states to establish a notification system under this proposal. We
estimate that nine additional states that primarily use managed care
for long-term services and supports (LTSS) (Michigan, North Carolina,
New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, and Virginia)
would delegate receipt of this information to their Medicaid managed
care organizations. We further estimate that approximately half of the
remaining 26 states--that is, 13 states--would build an automated
system for receiving notification of hospital and SNF admissions
consistent with this proposed rule.
We estimate that, on average, this work could be accomplished in a
month with one programmer and one business analyst to define
requirements. Accordingly, we estimate a one-time burden of 2,080 hours
(13 states * 40 hr per week * 4 weeks) per worker. Since half of the
cost would be offset by 50 percent federal financial participation for
Medicaid administrative activities, we estimate a cost of $85,176
(2,080 hr * $81.90/hr * 0.50) for a programmer and a cost of $71,843
(2,080 hr * $69.08/hr * 0.50) for a business analyst. In aggregate, we
estimate a burden of 4,160 hours (2,080 hr for a programmer + 2,080 hr
for a business analyst) at a cost of $157,019 ($85,176 for a programmer
+ $71,843 for a business analyst) for the update.
Because of the possible wide variability in states' approaches in
implementing this requirement, we solicit comment on and any other
suggestions for modeling state
[[Page 55044]]
approaches and costs related to this provision. In addition, we believe
that we have no reasonable way of estimating or illustrating burden in
later years. The expected behavior among states is unknown relative to
how often they will modify their notification mechanisms. Given the
uncertainty involved in estimating state behavior, we are estimating a
minimum of zero burden in future years on plans. The maximum burden
would be the estimated first-year cost. However, we believe the maximum
estimate is unlikely to be accurate since it would involve developing
an automated notification system from the beginning rather than
modifying an existing system. We solicit public comment on our
assumptions.
b. Burden on Plans
(1) Contract Modifications With State Medicaid Agencies (Sec. 422.107)
For the initial year, we expect it would take 8 hours at $136.44/hr
for a lawyer to update their plan's contract with the state Medicaid
agency. Since states are identifying the high-risk populations for
which they wish to be notified, it is reasonable to project that every
D-SNP contract would negotiate one contract modification with the state
Medicaid agency. There are 190 D-SNP contracts as of June 2018, of
which 37 contracts, or 12.7 percent (about one-eighth), are FIDE
SNPs.\32\ We do not have a precise count of D-SNPs that will likely
meet the proposed definition of a HIDE SNP. We assume another 12.7
percent of the 190 D-SNP contracts would be HIDE SNP contracts. Since
the notification requirements are only applicable to D-SNPs that are
not FIDE SNPs or HIDE SNPs, we expect that the number of contracts
needing modification is 190 D-SNP contracts, less 37 FIDE SNP
contracts, less 37 HIDE SNP contracts, or 116 D-SNP contracts. In
aggregate, we estimate a one-time first year burden of 928 hours (116
D-SNPs * 8 hr) at a cost of $126,616 (928 hr * $136.44/hr).
---------------------------------------------------------------------------
\32\ Centers for Medicare & Medicaid Services (2018, June). SNP
Comprehensive Report. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.
---------------------------------------------------------------------------
We believe that we have no reasonable way of estimating or
illustrating burden in later years. The expected behavior among states
is unknown relative to how often they will modify their contracts with
D-SNPs on this particular matter. For example, state Medicaid agencies
may remain satisfied with the initial year selection of high-risk
groups and see no reason to modify their contracts in later years. In
contrast, other state Medicaid agencies may seek to expand the
notification requirement to encompass additional groups of high-risk
dually eligible individuals and may therefore modify their contracts on
this basis.
Given the uncertainty involved in estimating state behavior, we are
estimating a minimum of zero burden in subsequent years on plans. The
maximum burden would be the first year costs. However, we believe this
estimate is unlikely to be accurate given our expectation that
contractual changes after the first year would be iterative at most. We
solicit public comment on our assumptions and whether there are
reasonable ways of modeling state behavior.
(2) Notifications to State Medicaid Agencies or Their Designees (Sec.
422.107(d))
We have noted previously the broad flexibility in notification
options for states. We also note that MA organizations are already
required to have systems that are sufficient to organize, implement,
control, and evaluate financial and marketing activities, the
furnishing of services, the quality improvement program, and the
administrative and management aspects of the organization (Sec.
422.503(b)(4)(ii)). Independent of the state Medicaid agency's
selection of high-risk populations, protocols, and notification
schedules, an MA organization's most likely method of sharing this
notification would be through the use of an automated system that could
identify enrollees with criteria stipulated by the states and issue
electronic alerts to specified entities. We do not believe that this
work is very complex. Therefore, we estimate it could be accomplished
in a month with one programmer and one business analyst to define
requirements. The burden would be at the contract, not the plan, level
and, as noted in section II.A.2.a. of this proposed rule, we estimate
116 affected D-SNP contracts. Accordingly, we estimate a first year
burden of 18,560 hours (116 contracts * 40 hr * 4 weeks) per worker.
The cost for programming would be $1,520,064 (18,560 hr * $81.90/hr)
for a programmer and $1,282,125 (18,560 hr * $69.08/hr) for a business
analyst. In aggregate, we estimate a burden of 37,120 hours (18,560 hr
for a programmer + 18,560 hr for a business analyst) at a cost of
$2,802,189 ($1,520,064 + $1,282,125).
Table 3 summarizes the burden of this provision.
[GRAPHIC] [TIFF OMITTED] TP01NO18.006
[[Page 55045]]
As indicated earlier, depending on each state's capacity, this
initial year burden may suffice for several years or may change
annually if states expand and change their criteria annually.
Consequently, we are only estimating the initial year burden. The
second and third year burden could therefore range between $0 and the
full $3.1 million cost estimated for the first year. We are estimating,
for years 2 and 3, a minimum of zero burden (the lower end of the
range) because it is our understanding that most states and plans would
not incur programming or contract related burden in years 2 and 3. We
acknowledge that some states and plans may incur such burden. However,
we have no reliable way to estimate the burden currently. We seek
public input to help us confirm whether our zero burden estimate for
years 2 and 3 is reasonable.
3. ICRs Regarding Unified Grievance and Appeals Procedures for Dual
Eligible Special Needs Plans and Medicaid Managed Care Plans at the
Plan Level (Sec. Sec. 422.560 Through 422.562, 422.566, 422.629
Through 422.634, 438.210, 438.400, and 438.402)
As described in section II.A.2.b. of this rule, we propose to
establish, for inclusion in contracts for applicable integrated plans
as defined in proposed Sec. 422.2 no later than 2021, procedures
unifying Medicare and Medicaid grievances and appeals procedures in
accordance with the newly enacted amendments to section 1859(f) of the
Act. We also propose to establish new regulations to require all dual
eligible special needs plans (D-SNPs) to assist beneficiaries with
Medicaid coverage issues and grievances at Sec. 422.562(a)(5). The
proposed requirements and burden will be submitted to OMB for approval
under control number 0938-0753 (CMS-R-267).
As of June 2018, the CMS website listed 190 D-SNP contracts with
412 D-SNP plans that have at least 11 members. The universe of D-SNPs
to which our proposed unified grievance and appeals procedures would
apply is comprised of D-SNPs that are either fully integrated dual
eligible special needs plans (FIDE SNPs) or highly integrated dual
eligible special needs plans (HIDE SNPs) with exclusively aligned
enrollment--that is, where all of the plan's membership receives
Medicare and Medicaid benefits from the same organization. Currently,
exclusively aligned enrollment occurs in only eight states: Florida,
Idaho, Massachusetts, Minnesota, New Jersey, New York, Tennessee, and
Wisconsin. Currently, there are only 37 D-SNPs operating under 34
contracts with 150,000 enrollees that could be classified as FIDE SNPs
or HIDE SNPs which operate in states with exclusively aligned
enrollment. The 150,000 enrollment figure for contract year 2018 is
projected to grow to 172,000 (150,000 * 1.145) \33\ enrollees by 2021,
the first year that compliance with these provisions would be required.
While unifying grievance and appeals provisions would necessitate
states with exclusively aligned enrollment policies to modify their
Medicaid managed care plan contracts to incorporate the new
requirements, it would impose this burden on fewer than 10 states and
would not impose additional burden for plans from a contracting
standpoint, thereby falling below the threshold for PRA purposes.
---------------------------------------------------------------------------
\33\ Table IV.C1, ``Private Health Enrollment'' in 2018 Trustee
Report, accessible at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/TR2018.pdf.
---------------------------------------------------------------------------
We believe that our proposed requirements related to integrated
organization determinations and integrated grievances should not be
altogether unfamiliar to applicable integrated plans because, in
general terms, we have proposed to adopt whichever of the current MA D-
SNP or Medicaid managed care plan contract requirements under parts 422
and 438, respectively, was more protective of the rights of the
beneficiary and/or provided the most state flexibility, consistent with
the statutory requirements of section 1859(f)(8) of the Act.
Furthermore, we believe that by unifying Medicare and Medicaid
integrated organization determination and grievance requirements for
applicable integrated plans (that is, FIDE SNPs and HIDE SNPs with
exclusively aligned enrollment), we are ultimately reducing the level
of burden on these organizations.
The burden associated with the implementation of our proposed
integrated organization determination and integrated grievance
procedures is summarized in section IV.B.3.a. of this proposed rule. As
detailed in IV.B.3.b. of this proposed rule, the PRA exempts the
information collection activities undertaken to administer our proposed
unified appeals procedures. As detailed in IV.B.3.c. of this proposed
rule, we believe the requirements for all D-SNPs to assist enrollees
with Medicaid coverage issues and grievances in proposed Sec.
422.562(a)(5) is also exempt from the PRA.
a. Integrated Organization Determinations and Integrated Grievances
(Sec. Sec. 422.629, 422.630, and 422.631)
Section 422.631 would require each applicable integrated plan to
issue one integrated organization determination, so that all requests
for benefits covered by applicable integrated plans would be subject to
the same integrated organization determination process. In Sec.
422.631(d)(1), we would require that an applicable integrated plan send
an integrated notice when the organization determination is adverse to
the enrollee. The proposed notice would include information about the
determination, as well as information about the enrollee's appeal
rights for both Medicare and Medicaid covered benefits. Though
integrating information on Medicare and Medicaid appeal rights would be
a new requirement, we note that requirements for a notice and the
content of the notice largely align with current requirements in
Medicaid (Sec. 438.404(b)) and MA (Sec. 422.572(e)). We believe that
this proposed provision would have minimal impact on plans based on our
understanding of how plans that would meet the definition of an
applicable integrated plan under the proposed rule currently handle
coverage determinations for full-benefit dual eligible individuals
receiving Medicare and Medicaid services through the plan. Currently if
such a plan were to deny or only partially cover a Medicaid service
never covered by Medicare (like a personal care attendant or a clear
request for Medicaid coverage), it would only issue a Medicaid denial
(one notice). Under this proposed rule, it would do the same (that is,
issue one notice). On the other hand, if the plan denied a service that
is covered under either Medicare or Medicaid, such as home health
services, we believe that the plan in most, if not all, states would
issue an integrated determination notice that includes information
about the application of Medicare and Medicaid coverage criteria to the
requested service and how to appeal under both Medicare and Medicaid
(one notice). This proposed rule would codify this practice for
applicable integrated plans.
Also under current law, if the plan covered a service such as
durable medical equipment or home health services under Medicaid, but
denied the service under Medicare's rules, it would issue a Medicare
denial even though the service was actually covered by the plan based
on its Medicaid contract. Under this proposed rule, a plan covering
both Medicare and Medicaid benefits would no longer need to issue a
notice in this
[[Page 55046]]
situation. We do not have data to estimate the number of instances in
which D-SNPs currently issue denial notices related to overlap
services; therefore, we are unable to estimate the reduction in plan
burden resulting from our proposed unified appeals requirements.
However, we solicit feedback on the burden imposed on integrated plans
by having to send such a Medicare denial notice when the service is
covered by the plan under Medicaid rules. We are developing an
integrated denial notice for use by applicable integrated plans. This
form, and its associated requirements and burden, will be submitted to
OMB for approval separately from this proposed rule once it is
developed.
We estimate negligible impacts on information collection activities
involved in unifying grievances associated with our proposed provisions
at Sec. 422.630, as detailed later in this section. Under Sec.
422.630(b), applicable integrated plans would be required to accept
grievances filed at any time consistent with the Medicaid standard at
Sec. 438.402(c)(2)(i). This change would have the net effect of
permitting enrollees to file a grievance for a Medicare-covered service
outside of the current 60-day timely filing standard, as measured from
the date of the event or incident that precipitated the grievance. The
provision would effectively eliminate the timely filing period for
Medicare-related grievances. We do not expect this proposal to increase
the volume of grievances that an applicable integrated plan would be
responsible for handling since we believe that the timeframes for
filing Medicare grievances were designed to be consistent with current
practice and were set in place only to eliminate complaint outliers.
Furthermore, as detailed later in this section, even a four-fold
increase in grievance volume would still have a negligible aggregate
burden because of the small number of contracts in states that
currently require exclusively aligned enrollment.
Under Sec. 422.630(c), enrollees of applicable integrated plans
could file integrated grievances with the plan orally or in writing, in
alignment with current Medicare and Medicaid requirements, or with the
state, in states that have existing processes for accepting Medicaid
grievances in place in accordance with Sec. 438.402(c)(3). Because
this proposed provision simply extends an existing avenue for filing
grievances, in states where it exists, for enrollees to file Medicaid
benefits grievances with the state, we do not expect this proposal to
increase the volume of grievances that either states or applicable
plans would be responsible for handling.
Section 422.630(d) would permit an enrollee to file an expedited
grievance, which is available under current law for Medicare-covered,
but not Medicaid-covered, benefits. We estimate that the availability
of an expedited grievance for Medicaid benefits would have a negligible
impact on information collection activities because applicable
integrated plans would already have procedures in place to handle
expedited grievances for Medicare-covered services, which could be
leveraged for Medicaid-covered services. Furthermore, the availability
of the expedited resolution pathway (where under current law there is
only one resolution pathway for Medicaid-covered services) would have
no impact on the volume of grievances.
Section 422.630(e)(1) would require that an applicable integrated
plan resolve a standard (non-expedited) grievance within 30 days
consistent with the MA standard; under Medicaid, the timeframe is
established by the state but may not exceed 90 calendar days from day
the plan receives the grievance. We estimate that this change in
timeframe would have a negligible impact on information collection
activities because applicable integrated plans already have business
processes in place to comply with a 30-day timeframe under MA.
Section 422.630(e)(2) would require the applicable integrated plan,
when extending the grievance resolution timeframe, to make reasonable
efforts to notify the enrollee orally and send written notice of the
reasons for the delay within 2 calendar days. We do not believe that
this provision would have more than a negligible impact on plans since
this proposal adopts MA requirements for how an applicable integrated
plan must notify an enrollee of an extension and the Medicaid managed
care requirement for the timeliness standard. Thus, applicable
integrated plans would already have business processes in place to
comply with these requirements.
Although we do not estimate cost impacts for applicable integrated
plans related to information collection activities involved in unifying
grievances associated with our proposed provisions at Sec. 422.630,
some of the individual provisions in Sec. Sec. 422.630 and 422.631
would necessitate operational and systems changes on the part of
applicable integrated plans, and others would result in savings to
applicable integrated plans. We estimate both the burden and savings
associated with changes to policies and procedures, record maintenance,
grievance notice consolidations, and savings for our proposed
integrated organization determination procedures at Sec. 422.631 and
integrated grievance procedures at Sec. 422.630.
(1) Updates to Policies and Procedures
There would be an initial one-time burden for plans to update their
policies and procedures to reflect the proposed new integrated
organization determination and grievance procedures. Under Sec. Sec.
422.630 and 422.631, we estimate it would take 8 hours at $69.08/hr for
a business operations specialist to revise current policies and
procedures. In aggregate, we estimate a one-time burden of 272 hours (8
hr * 34 contracts) at a cost of $18,790 (272 hr * $69.08/hr).
While there might be some update burden in future years, we
consider this unlikely and, even if it were to occur, it would not be
on the same magnitude as in the first year. We are therefore estimating
a zero burden for years 2 and 3, though we acknowledge the unlikely
possibility that costs could be as high as in year 1--that is, $18,790.
(2) Record Maintenance
D-SNPs, like other MA plans, are currently required to maintain
records for grievances (Sec. 422.504(d)). However, Sec. 422.629(h)
would require the maintenance of specific data elements, consisting of
a general description of the reason for the integrated grievance; the
date of receipt; the date of each review or, if applicable, the review
meeting; the resolution at each level of the integrated grievance, if
applicable; the date of resolution at each level, if applicable; and
the name of the enrollee for whom the integrated grievance was filed.
There would be an initial one-time burden for plans to revise their
systems for record-keeping related to integrated grievances. We
anticipate this task would take a programmer 3 hours at $81.90/hr.
Three hours is consistent with the per-response time estimated in the
recent Medicaid Managed Care May 2016 final rule (81 FR 27498). In
aggregate, we estimate a one-time burden of 102 hours (3 hr * 34
contracts) at a cost of $8,354 (102 hr * $81.90/hr).
(3) Grievance Notice Consolidation
Section 422.630(e) would require that applicable integrated plans
issue a notice upon resolution of the integrated grievance, unless the
grievance was made orally and the enrollee did not request a written
response. We assume in our analysis that plans issue two separate
Medicare and Medicaid
[[Page 55047]]
grievance resolution notices under current practice when a grievance is
made in writing, whereas under this proposal they would issue one
consolidated notice. To calculate savings, we must add the cost of
notification and the cost of grievance review.
(4) Cost of Notification
To calculate the savings due to Medicare and Medicaid notice
consolidation, we utilize the following figures: (1) The number of
enrollees in the exclusively aligned plans in contract year 2021, which
is 172,000; (2) the time of notification using either a standard notice
or a copy of the decision prepared by the reviewer (traditionally such
a routine notification is estimated as 1 minute per notification (1/60
of an hour)); (3) the hourly wage for a business operations specialist;
and (4) the percent of total enrollees expected to file a grievance
(the recent Medicaid Managed Care May 2016 final rule (81 FR 27498)
estimates a 2 percent filing rate, while the burden under OMB control
number 0938-0753 (CMS-R-267) estimates 6.8 percent (17 percent of
enrollees that are dissatisfied * 40 percent of dissatisfied enrollees
who file a grievance)).
For purposes of specificity, we assume the average of these two
estimates, 4.4 percent (\1/2\ * [6.8 percent + 2 percent]) represents
the percent of enrollees filing a grievance with the integrated plan.
Therefore, we estimate the annual savings due to notifications as 126
hours (1 minute * 172,000 enrollees * 0.044) at a cost of $8,704 (126
hours * $69.08/hr). The aggregate savings for years 2 and 3 are 252
hours (1 minute x 172,000 enrollees * 0.044 * 2 years) at a cost of
$17,408 (252 hours * $69.08 * 2 years).
(5) Cost of Grievance Review
We assume the review will be done by a business operations
specialist. Based on the Medicaid Managed Care May 2016 final rule (81
FR 21498), we assume the average grievance takes 30 minutes for a
business operations specialist to resolve. Thus, the aggregate annual
savings for review is 3,784 hours (172,000 enrollees * 0.044 * 0.5 hr)
at a cost of $261,399 (3,784 hr * $69.08/hr). We estimate the aggregate
savings for years 2 and 3 to be 7,568 hours (172,000 enrollees * 0.044
x 0.5 hr * 2 years) at a cost of $522,797, (3,784 hr * $69.08/hr * 2
years).
(6) Storage
The cost of storage is not expected to change under Sec.
422.629(h)(3) since D-SNPs are currently required to store records
(Sec. 422.504(d)), and the provision would not impose any new or
revised storage requirements or burden.
b. Unified Appeals Procedures (Sec. Sec. 422.629, 422.633, and
422.634)
The implementing regulations of the PRA at 5 CFR 1320.4 exclude
information collection activities during the conduct of a civil action
to which the United States or any official or agency thereof is a
party, or during the conduct of an administrative action,
investigation, or audit involving an agency against specific
individuals or entities. We conclude that a beneficiary's appeal of an
adverse integrated coverage determination as proposed in this rule, and
the subsequent information collection activities necessitated by that
integrated appeal--for example, acknowledgement of integrated
reconsiderations at Sec. 422.629(g), recordkeeping related to
integrated appeals at Sec. 422.629(h), and notification of the
applicable integrated plan's integrated reconsideration determination
at Sec. 422.633(f)(4)--are exempt from the PRA on the basis that an
appeal is submitted in response to an administrative action against a
specific individual. Therefore, this exemption would cover any
information collection activities undertaken after the integrated
organization determination by an applicable integrated plan.
c. Assisting With Medicaid Coverage Issues and Grievances (Sec.
422.562(a)(5))
We did not calculate the burden of the requirement for all D-SNPs
to assist enrollees with the filing of their grievance or appeal as
required in proposed Sec. 422.562(a)(5), as we are assuming that
providing assistance is a usual and customary business practice that is
exempt from the PRA (5 CFR 1320.3(b)(2)).
d. Summary
The burden associated with the individual components of our
proposed provisions for unified grievance and appeals procedures for
applicable integrated plans, as well as aggregate cost, are summarized
in Table 4A.
[GRAPHIC] [TIFF OMITTED] TP01NO18.007
4. ICRs Regarding Proposal for Prescription Drug Plan Sponsors' Access
to Medicare Parts A and B Claims Data Extracts (Sec. 423.153)
As described in section II.A.3. of this proposed rule, section
50354 of the Bipartisan Budget Act of 2018 requires the establishment
of a process under which the sponsor of a PDP that provides
prescription drug benefits under Medicare Part D may request, beginning
in plan year 2020, that the Secretary provide on a periodic basis and
in an electronic format standardized extracts of Medicare Parts A and B
claims data about its plan enrollees. In this rule we propose to add a
new Sec. 423.153(g) to implement the process for requesting this data.
More specifically, in order to receive this data, PDP plans would
be required to request the data and complete an attestation. We have
not finalized the operational aspects of this provision. Therefore,
this segment of the rule does not constitute a means for notice and
comment as referenced in 5 CFR 1320.8(d)(3) and CMS will seek a comment
through separate Federal
[[Page 55048]]
Register notices per the Paperwork Reduction Act.
5. ICRs Regarding Medicare Advantage and Part D Prescription Drug Plan
Quality Rating System (Sec. Sec. 422.162(a) and 423.182(a), Sec. Sec.
422.166(a) and 423.186(a), Sec. Sec. 422.164 and 423.184, and
Sec. Sec. 422.166(i)(1) and 423.186(i)(1))
As described in section III.B.1. of this proposed rule, we are
proposing measure updates for the 2022 and 2023 Star Ratings,
enhancements to the cut point methodology for non-CAHPS measures, and a
policy for calculating the Part C and D Star Ratings when extreme and
uncontrollable circumstances occur. The proposed provisions would not
change any respondent requirements or burden pertaining to any of CMS's
Star Ratings-related PRA packages, including: OMB control number 0938-
0732 for CAHPS (CMS-R-246), OMB control number 0938-0701 for HOS (CMS-
10203), OMB control number 0938-1028 for HEDIS (CMS-10219), OMB control
number 0938-1054 for Part C Reporting Requirements (CMS-10261), and OMB
control number 0938-0992 for Part D Reporting Requirements (CMS-10185).
Since the proposed provisions would not impose any new or revised
information collection requirements (that is, reporting recordkeeping,
or third-party disclosure requirements) or burden, we are not making
changes under any of the aforementioned control numbers.
6. ICRs Regarding Improving Clarity of the Exceptions Timeframes for
Part D Drugs (Sec. Sec. 423.568, 423.570, and 423.572)
The proposed provisions would not impose any new or revised
information collection requirements (that is, reporting, recordkeeping,
or third-party disclosure requirements) or burden. Consequently, the
provisions are not subject to the PRA.
7. ICRs Regarding Preclusion List Requirements for Prescribers in Part
D and Individuals and Entities in MA, Cost Plans, and PACE (Sec. Sec.
422.222 and 423.120(c)(6))
As described in section III.C.1. of this proposed rule, the
proposed provisions would not involve activities for plan sponsors and
MA organizations outside of those described in the April 2018 final
rule. The proposed provisions are, generally speaking, clarifications
of intended policy and would not impose any new or revised information
collection requirements (that is, reporting, recordkeeping, or third-
party disclosure requirements) or burden. Consequently, the provisions
are not subject to the PRA.
8. ICRs Regarding Medicare Advantage Risk Adjustment Data Validation
Provisions (Sec. Sec. 422.300, 422.310(e), and 422.311(a))
As described in section III.C.2. of this proposed rule, we are
proposing that extrapolation may be utilized as a valid part of audit
authority in Part C, as it has been historically a normal part of
auditing practice throughout the Medicare program. We are also
proposing that this extrapolation authority be applied to the payment
year 2011 RADV contract-level audits and all subsequent audits to
reduce the Part C improper payment rate. Additionally, we are proposing
not to apply a FFS Adjuster to audit findings.
The proposed provisions would not impose any new or revised
information collection requirements (that is, reporting, recordkeeping,
or third-party disclosure requirements) or burden since the utilization
of extrapolation will not affect the existing process for MA
organizations submitting medical record documentation pursuant to RADV
audits. Consequently, the provisions are not subject to the PRA.
C. Summary of Proposed Information Collection Requirements and Burden
BILLING CODE 4120-01-P
[[Page 55049]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.008
BILLING CODE 4120-01-C
[[Page 55050]]
D. Submission of PRA-Related Comments
We have submitted a copy of this proposed rule to the Office of
Management and Budget (OMB) for its review of the rule's information
collection and recordkeeping requirements. These requirements are not
effective until they have been approved by OMB.
To obtain copies of the supporting statement and any related forms
for the proposed collections previously discussed, please visit CMS's
website at: https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or call the Reports
Clearance Office at (410) 786-1326.
We invite public comments on these proposed information collection
requirements. If you wish to comment, please submit your comments
electronically as specified in the ADDRESSES section of this proposed
rule and identify the rule (CMS-4185-P) and where applicable the ICR's
CFR citation, CMS ID number, and OMB control number.
See the DATES and ADDRESSES sections of this proposed rule for
further information.
IV. Regulatory Impact Analysis
A. Statement of Need
This rule proposes to implement specific provisions of the
Bipartisan Budget Act of 2018 related to additional telehealth
benefits, MA dual eligible special needs plans (D-SNPs), and Part D
sponsors' access to Medicare claims data. The rule also proposes to
improve quality and accessibility; clarify certain program integrity
policies; reduce burden on providers, MA organizations, and Part D
sponsors through providing additional policy clarification; and
implement other technical changes regarding quality improvement.
Although satisfaction with the MA and Part D programs remains high,
these proposals are responsive to input we received from stakeholders
while administering the programs, as well as through our requests for
comment. CMS decided to modify the MA and Part D Prescription Drug Plan
Quality Rating System in response to comments from the proposed rule
entitled Medicare Program; Contract Year 2019 Policy and Technical
Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-
for-Service, The Medicare Prescription Drug Benefit Programs, and the
PACE program (November 28, 2017, 82 FR 56336).
In this proposed rule, we are proposing policies to continue to
drive affordable private plan options for Medicare beneficiaries that
meet their unique healthcare needs, such as through supporting
innovation in telehealth among MA plans to provide more options and
additional benefits for MA enrollees. These proposed provisions align
with the Administration's focus on the interests and needs of
beneficiaries, providers, MA plans, and Part D sponsors.
B. Overall Impact
We examined the impact of this proposed 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 Social
Security Act (the Act), section 202 of the Unfunded Mandates Reform Act
of 1995 (UMRA) (March 22, 1995; Pub. L. 104-4), Executive Order 13132
on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C.
804(2)), and Executive Order 13771 on Reducing Regulation and
Controlling Regulatory Costs (January 30, 2017).
The RFA, as amended, requires agencies to analyze options for
regulatory relief of small businesses, if a rule has a significant
impact on a substantial number of small entities. For purposes of the
RFA, small entities include small businesses, nonprofit organizations,
and small governmental jurisdictions.
This proposed rule affects MA plans and Part D sponsors (NAICS
category 524114) with a minimum threshold for small business size of
$38.5 million (http://www.sba.gov/content/small-business-size-standards). This proposed rule additionally affects hospitals (NAICS
subsector 622) and a variety of provider categories, including
physicians and specialists (NAICS subsector 621).
To clarify the flow of payments between these entities and the
federal government, note that MA organizations submit bids (that is,
proposed plan designs and projections of the revenue needed to provide
those benefits, divided into three categories--basic benefits,
supplemental benefits, and Part D drug benefits) in June 2019 for
operation in contract year 2020. These bids project payments to
hospitals, providers, and staff as well as the cost of administration
and profits. These bids in turn determine the payments from the
Medicare Trust Fund to the MA organizations that pay providers and
other stakeholders for their provision of covered benefits to
enrollees. Consequently, our analysis will focus on MA organizations.
There are various types of Medicare health plans, including MA
plans, Part D sponsors, demonstrations, section 1876 cost plans,
prescription drug plans (PDPs), and Program of All-Inclusive Care for
the Elderly (PACE) plans. Forty-three percent of all Medicare health
plan organizations are not-for-profit, and 31 percent of all MA plans
and Part D sponsors are not-for-profit. (These figures were determined
by examining records from the most recent year for which we have
complete data, 2016.)
There are varieties of ways to assess whether MA organizations meet
the $38.5 million threshold for small businesses. The assessment can be
done by examining net worth, net income, cash flow from operations, and
projected claims as indicated in their bids. Using projected monetary
requirements and projected enrollment for 2018 from submitted bids, 32
percent of the MA organizations fell below the $38.5 million threshold
for small businesses. Additionally, an analysis of 2016 data--the most
recent year for which we have actual data on MA organization net
worth--shows that 32 percent of all MA organizations fall below the
minimum threshold for small businesses.
If a proposed rule may have a significant impact on a substantial
number of small entities, the proposed rule must discuss steps taken,
including alternatives, to minimize burden on small entities. While a
significant number (more than 5 percent) of not-for-profit
organizations and small businesses are affected by this proposed rule,
the impact is not significant. To assess impact, we use the data in
Tables 18 A and B, which show that the raw (not discounted) net effect
of this proposed rule over 10 years is $20.8 million. Comparing this
number to the total monetary amounts projected to be needed just for
2020, based on plan submitted bids, we find that the impact of this
rule is significantly below the 3 to 5 percent threshold for
significant impact. Had we compared the 2020 impact of the proposed
rule to projected 2020 monetary need, the impact would be still less.
Consequently, the Secretary has determined that this proposed rule
will not have a significant economic impact on a substantial number of
small entities, and we have met the requirements of the RFA. In
addition, section 1102(b) of the Act requires us to prepare a
regulatory analysis for any final rule under title XVIII, title XIX, or
Part B of Title XI of the Act that may have significant impact on the
[[Page 55051]]
operations of a substantial number of small rural hospitals. We are not
preparing an analysis for section 1102(b) of the Act because the
Secretary certifies that this proposed rule will not have a significant
impact on the operations of a substantial number of small rural
hospitals.
Section 202 of 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 2018, that threshold is approximately $150
million. This proposed rule is not anticipated to have an effect on
state, local, or tribal governments, in the aggregate, or on the
private sector of $150 million or more.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule that imposes
substantial direct requirement costs on state and local governments,
preempts state law, or otherwise has federalism implications. Since
this proposed rule does not impose any substantial costs on state or
local governments, the requirements of Executive Order 13132 are not
applicable.
If regulations impose administrative costs on reviewers, such as
the time needed to read and interpret this proposed rule, then we
should estimate the cost associated with regulatory review. There are
currently 750 MA contracts (which also includes PDPs), 50 State
Medicaid Agencies, and 200 Medicaid Managed Care Organizations (1,000
reviewers total). We assume each entity will have one designated staff
member who will review the entire rule. Other assumptions are possible
and will be reviewed after the calculations.
Using the wage information from the Bureau of Labor Statistics
(BLS) for medical and health service managers (code 11-9111), we
estimate that the cost of reviewing this rule is $107.38 per hour,
including fringe benefits and overhead costs (http://www.bls.gov/oes/current/oes_nat.htm). Assuming an average reading speed, we estimate
that it will take approximately 12.5 hours for each person to review
this proposed rule. For each entity that reviews the rule, the
estimated cost is therefore, $1,342 (12.5 hours * $107.38). Therefore,
we estimate that the total cost of reviewing this regulation is
$1,342,000 ($1,342 * 1000 reviewers).
Note that this analysis assumed one reader per contract. Some
alternatives include assuming one reader per parent entity. Using
parent organizations instead of contracts would reduce the number of
reviewers to approximately 500 (assuming approximately 250 parent
organizations), and this would cut the total cost of reviewing in half.
However, we believe it is likely that reviewing will be performed by
contract. The argument for this is that a parent organization might
have local reviewers; even if that parent organization has several
contracts that might have a reader for each distinct geographic region,
to be on the lookout for effects of provisions specific to that region.
In accordance with the provisions of Executive Order 12866, this
rule was reviewed by the Office of Management and Budget (OMB).
C. Anticipated Effects
1. Requirements for Medicare Advantage Plans Offering Additional
Telehealth Benefits (Sec. Sec. 422.100, 422.135, 422.252, 422.254, and
422.264)
As stated in the preamble, section 50323 of the Bipartisan Budget
Act of 2018 allows MA plans to provide ``additional telehealth
benefits'' to enrollees starting in plan year 2020 and treat them as
basic benefits for purposes of bid submission and payment by CMS. We
propose to codify requirements at Sec. 422.135, which would authorize
and set standards for MA plans to offer additional telehealth benefits.
The proposed regulation has the following impacts.
There are two primary aspects of the proposed additional telehealth
provision that could affect the cost and utilization of MA basic
benefits, with a corresponding impact on Medicare program expenditures.
The most direct effect is the reclassification of certain telehealth
services covered by MA plans pre-Bipartisan Budget Act of 2018 from
supplemental benefits to basic benefits. This change will lead to
higher basic benefit bids, as the cost of additional telehealth
benefits will be included in the development of the basic benefit bid.
The impact on the basic benefit bid may be muted due to the exclusion
of capital and infrastructure costs and investments related to
additional telehealth benefits from the bid.
Prior to estimating the impact on the bid, we point out several
other sources of impact. Many studies have argued that telehealth will
increase utilization of medical services by making them more
accessible. However, the increased utilization could lead to increased
savings or cost. The increased utilization could lead to significant
savings due to prevention of future illness. Alternatively, the
increased utilization could lead to increased costs if enrollees start
seeing doctors for complaints on which they did not traditionally seek
medical advice. We cite below studies for each possibility.
Additionally, if there are increased telehealth visits, providers may
request increased face-to-face visits to protect themselves from
liability.
Consequently, there are four potential impacts of this provision,
which we discuss in more detail later in this section. The four areas
are as follows:
Impact on the Medicare Trust Fund
Savings for Enrollees due to Decreased Travel Time to
Providers
Savings from Illness Prevention due to Increased Access to
Services
Increased Costs if Unnecessary Medical Visits Increase
Because of the wide variability in potential impact, we solicit
comments on best practices in telehealth and the resulting savings.
a. Impact on the Medicare Trust Fund
Superficially, there appears to be no program change since the
provision simply reclassifies certain benefits as basic instead of
supplemental. Thus, the same benefits are provided. However, a closer
look at the language and assumptions of the provision show that, while
collectively additional telehealth benefits will yield a negligible
change in program spending, there is a small transfer of costs (0.002
percent of the MA baseline) from enrollees to the Medicare Trust Fund,
associated with reclassifying these benefits from supplemental to basic
benefits. Supplemental benefits are generally paid with rebates while
basic benefits are paid by a capitation rate, calculated with reference
to the bid. For the plans to provide benefits through rebates requires
additional funding since the amount of rebates provided by the Medicare
Trust Fund averages only $0.66 on the dollar. Thus, the effect of this
provision is that either the enrollee pays a lower supplemental premium
or receives richer supplemental benefits. In either case, the enrollee
saves and the Medicare Trust Fund incurs a cost. It follows that this
provision creates a transfer from enrollees to the Medicare Trust Fund.
After accounting for infrastructure costs, and backing out the Part B
premium, the extra cost to the Medicare Trust Fund is projected to be
$80 million over 10 years. The calculations for the first 10 annual
estimates are presented in Table 6 of this rule and discussed in the
narrative.
In order to estimate the 10-year impact (2020 through 2029) of the
proposed additional telehealth benefits provision on the Medicare Trust
Fund, we considered the following six factors.
[[Page 55052]]
We first estimated the costs of additional telehealth
benefits that are to be transferred from supplemental benefits to basic
benefits. Using the 2019 submitted bid information, we estimated that
$0.09 per member per month (pmpm) would be transferred. We computed
$0.09 by examining and averaging the largest organizations' telehealth
benefits, particularly under the category ``Web and Phone Based
Technology.'' The reason for basing estimates on the largest
organizations is that only the largest organizations included the
category ``Web and Phone Based Technology'' as a separate line item in
their bids. The other organizations had multiple, non-telehealth
benefits, in the same line as the telehealth benefits, and so we were
not able to distinguish the costs between telehealth and non-telehealth
for the smaller organizations. Information from the 2018 Medicare
Trustees Report \34\ shows that the applicable medical-inflation trend
that should be applied to the $0.09 pmpm is 5.2 percent per year; the
average trend can be derived from information in Table IV.C3 of this
report.
---------------------------------------------------------------------------
\34\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/TR2018.pdf.
---------------------------------------------------------------------------
We applied the pmpm amounts to the projected MA enrollment
for the years 2020 through 2029. The source of the projected MA
enrollment is Table IV.C1 of the 2018 Medicare Trustees Report.
We assumed that 15 percent of the additional telehealth
benefits would be considered capital and infrastructure expenses. As
discussed in the preamble, these expenses are excluded from the
Medicare Trust Fund payments for additional telehealth benefits. We
obtained the 15 percent assumption by subtracting the 85 percent
required Medical Loss Ratio (MLR) from 100 percent. We used the MLR as
a proxy for the medical share of provider payments.
We applied the average rebate percentage of 66 percent,
which is based on the expected submitted bid information, including
expected enrollment and expected average Star Ratings.
We applied a factor of 86 percent to the calculation,
which represents the exclusion or the backing out of the Part B
premium.
However, per OMB guidance, ordinary inflation should be
carved out of estimates, while medical inflation, which outpaces
ordinary inflation (as well as enrollment growth), may be retained. The
source of the ordinary inflation is Table IV.D1 of the 2018 Medicare
Trustees Report. It is 2.6 percent per year for each of the years 2020
through 2029.
Combining these six factors, we calculated the net costs to the
Medicare Trust Fund to be $6.1 million in 2020, $6.5 million in 2021,
$6.9 million in 2022, $7.3 million in 2023, and $7.7 million in 2024.
We calculated the net costs to the Medicare Trust Fund for years 2025
through 2029 to be $8.2 million, $8.5 million, $9.0 million, $9.5
million, and $9.9 million, respectively. The calculations of impact for
2020 through 2029 are summarized in Table 6. The total cost for all 10
years is found in the right-most column of Table 6, titled ``Net
Costs.''
BILLING CODE 4120-01-P
[[Page 55053]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.009
BILLING CODE 4120-01-C
[[Page 55054]]
b. Savings for Enrollees Due to Decreased Travel Time to Providers
Additional telehealth benefits will save enrollees the cost of
traveling to providers. Currently, original Medicare telehealth
benefits are used to bring healthcare services to MA enrollees,
including those in rural locations. Stakeholders have informed CMS that
MA enrollees like the use of telehealth services to reduce travel times
and have greater access to providers that may not otherwise be
available.
The analysis assumes a replacement of some face-to-face provider
visits with telehealth visits and no additional increase in overall
provider visits. Although, as discussed later in this section, there
are studies suggesting the possibility of increased provider visits due
to ease of access of telehealth, these studies are mainly theoretical
and furthermore suggest methods to curb the unwanted increase in
visits; it might therefore, be very reasonable to assume that there is
no increase. Another important point to bear in mind is that increased
telemonitoring does not cost the enrollee extra time. Once a system is
set up to electronically transfer medical measurements, the enrollee
does not have to spend extra time for this transmission. A provider
will only intervene if a medical measurement indicates the possibility
of an adverse medical event. However, in such a case, the expected
adverse medical event might be resolvable with a phone call or
medication adjustment and is less costly time-wise than an actual face-
to-face provider visit.
An additional concern with this estimation is that it does not take
into account that the current MA program already has certain telehealth
benefits, such as phone hotlines and telemonitoring. Therefore, it is
not accurate to estimate the effect of telehealth in general without
differentiating the former allowance of telehealth and the new
allowances afforded by this provision.
We believe that the primary driver of telehealth savings is not the
authority under the law to use it, but rather, increased availability
of telehealth technology and implementation. For example, although
current MA guidelines allow some telehealth services as supplemental
benefits, only the largest plans have provided specific, line item data
on it in their bid submissions.
Another example, illustrating that availability, not authority
under the law, is the primary driver of telehealth savings, is found in
national usage of telehealth. Although telehealth has always been
allowed by commercial plans, it is rapidly increasing now because of
increased availability and ease of implementation. Studies continually
point to the growth potential for using telehealth; these studies
emphasize that telehealth is not being used where it could be and that
the issues are feasibility and availability.\35\
---------------------------------------------------------------------------
\35\ See https://www.ncbi.nlm.nih.gov/pubmed/23406075. Also see
Harry Wang, Director Health and Mobile Product Research, Parks
Associates ``Virtual Health Care will revolutionize the Industry If
we let it'', Forbes, 2014, accessible at https://www.forbes.com/sites/ciocentral/2014/04/03/virtual-health-care-visits-will-revolutionize-the-industry-if-we-let-it/#4ee9a9e97c25.
---------------------------------------------------------------------------
Thus, allowing plans to offer additional telehealth benefits, or
reclassify their current supplemental telehealth benefits as basic
benefits, would not, by itself, increase telehealth usage. Rather, the
increased telehealth usage comes when telehealth technologies are
readily available and easy to implement. The goal of this provision is
to foster an atmosphere where both commercial and MA plans will be
equally interested in the increasingly accessible technology and seek
to incorporate it in their offerings.
In summary, we acknowledge the possibility that the estimates
below, assuming no increase in provider visits and not taking into
account current telehealth practices, may have elements of
overestimation. Because of our uncertainties, we invite industry
comments on our analysis.
To estimate the impact on enrollee travel time, we need four
estimates:
Average travel time and average travel distance per visit:
While it is difficult to estimate the savings in reduced travel time
quantitatively, since distances from enrollees to providers vary
significantly, to estimate the travel time to providers we use a former
CMS standard that providers should be located within 30 minutes or 30
miles of each enrollee. While this standard has since been replaced by
a more sophisticated measurement of access, we can use it as a proxy.
The former CMS standard was used because it is formulated simply in
terms of time (one-half hour) and miles (30 miles) and does not
differentiate among provider types. The current standards for access
involve sophisticated algorithms, which involve more than two
parameters (time and mileage), and additionally differ by geographic
location and provider types. Therefore, the current standards were not
suitable. We therefore assume that the midpoint, 15 minutes or 0.25
hour, represents the typical travel time to providers per enrollee
visit.\36\ We similarly believe that 15 miles (one-half of 30 miles) is
the average travel distance per provider visit. We note the group of
individual respondents varies widely from working and nonworking
individuals and by respondent age, location, years of employment, and
educational attainment. CMS estimates cost per hour for enrollees using
the occupational title ``All Occupations'' (occupation code 00-0000)
from the BLS, with a mean wage of $24.34/hour. Thus, the net savings
per enrollee per telehealth visit to providers would be $17.57 ($24.34
hourly wage * 0.25 minutes travel time * 2 (round trip) + 15 miles * 2
(round trip) * 18 cents a mile (cost of gasoline for medical
transportation \37\)). This is summarized in Table 7.
---------------------------------------------------------------------------
\36\ This would result in 30 minutes (2 * 15 minutes) roundtrip.
The following article using independent sources estimates 37
minutes, which is close to our estimate: https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.1130.
\37\ https://www.irs.gov/newsroom/standard-mileage-rates-for-2018-up-from-rates-for-2017.
---------------------------------------------------------------------------
Average number of visits per enrollee: The Center for
Disease Control (CDC) estimates that in 2014, 65-year-olds and older
average 5.89 visits per person.\38\
---------------------------------------------------------------------------
\38\ https://www.cdc.gov/nchs/products/databriefs/db292.htm.
---------------------------------------------------------------------------
Number of MA enrollees: Table IV.C1 of the 2018 Medicare
Trustees Report provides the projected MA enrollment.
Percent, per year, of provider visits that are telehealth:
Ideally, we would like an estimate on the number of total visits and
telehealth visits for 65-year-olds. However, these data are not
available. Therefore, we use the best available proportions. We proceed
as follows.
The CDC website cited above estimates 885 million provider visits
in 2014. This is an aggregate number over all age groups; the 885
million was not broken out further by age group.
Absent information on the proportion of telehealth visits among
total visits by 65-year-olds to providers, we use general averages
(across all age groups) with the understanding that some accuracy is
lost. The Statista website suggests 22 million telehealth visits in
2014.\39\ This implies that 2.49 percent (22/885) of all physician
visits were for telehealth.
---------------------------------------------------------------------------
\39\ https://www.statista.com/statistics/820756/number-of-telehealth-visits-in-us/.
---------------------------------------------------------------------------
Inferring growth rates from the numbers on the Statista website,
the projected low and high growth rate for telehealth services is 1.089
percent and 1.22 percent respectively. Other
[[Page 55055]]
websites give similar ranges. For example, in three places Becker gives
three estimates for telehealth growth rates of 14.3 percent, 16.5
percent, and 27.5 percent.\40\ Because of this variability, we use the
lower estimate for projected telehealth growth, which is about 1.089
percent. These numbers can be used to estimate the proportion of
provider visits that will be telehealth in future years. For example,
in 2015, we assume 1.089 (growth rate) * 2.49 percent (proportion of
provider visits that are telehealth in 2014) = 2.71 percent of provider
visits will be telehealth visits.
---------------------------------------------------------------------------
\40\ See https://www.beckershospitalreview.com/healthcare-information-technology/telemedicine-to-attract-7m-patient-users-by-2018-12-statistics-on-the-thriving-market.html; https://www.beckershospitalreview.com/telehealth/global-telemedicine-market-to-experience-16-5-annual-growth-rate-through-2023.html; https://www.beckershospitalreview.com/healthcare-information-technology/the-growth-of-telehealth-20-things-to-know.html.
---------------------------------------------------------------------------
Multiplying these four numbers together--average savings per visit
($17.57) * visits per enrollee (5.89) * number of MA enrollees *
percent of provider visits that are telehealth (2.49 percent * 1.089
per year)--we arrive at a conservative estimate of $60 million, growing
to $100 million in 2024, and $170 million in 2029. Had we used the
higher projected visits, we would have obtained $60 million, growing to
$540 million. The results are summarized in Table 8.
We emphasize that these results have a tendency toward
underestimation for the following reasons:
We have only estimated the impact on physician visits and
have not taken into account telehealth surgery and telemonitoring.
We have assumed an 8.9 percent growth rate.
We have applied the growth rate in telehealth for all age
groups to the 65 and older population.
On the other hand, we have not carved out current MA telehealth
utilization (an overestimating effect). However, we believe this is a
good starting point for estimation of savings to enrollees. In other
words, the use of the 2.49 percent estimate, above, would be reasonable
if MA enrollees currently have negligible access to telehealth and
then, as a result of this proposed rule, begin using telehealth at a
rate similar to the national average. However, there is presently some
telehealth coverage in MA, so the preceding method most likely yields a
substantial overestimate of the impact of the telehealth provision, and
thus the results are used for illustrative purposes only. As such, we
welcome comments, especially from groups that have data relevant to 65-
year-olds, on the rule-induced incremental use of telehealth.
These illustrative estimates do not reflect the possible effect of
increased unnecessary medical visits, that is, medical visits made
because of the ease of access of telehealth in situations when
enrollees normally would not seek medical care. We discuss our
rationale in section IV.C.1.d. of this proposed rule.
BILLING CODE 4120-01-P
[[Page 55056]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.010
BILLING CODE 4120-01-C
c. Savings From Illness Prevention Due to Increased Access to Services
Telehealth savings due to increased prevention may arise from
easier access to services. The additional telehealth benefits to be
included in the MA basic benefit bid stem from the Bipartisan Budget
Act of 2018 amendment of section 1852 of the Act. These services will
likely represent a mix of replacement of pre-Bipartisan Budget Act of
2018 face-to-face encounters and additional services. We believe that
increased coverage of the additional telehealth benefits will generally
result in an aggregate reduction in use of emergency room visits and
inpatient admissions because the relative increased ease of receiving
healthcare services should improve health outcomes and reduce avoidable
utilization that results from untreated conditions exacerbating
illness. Several studies predict that telehealth can significantly
reduce illness through prevention. We mention four areas: (1)
Healthcare management; (2) medication therapy management (MTM); (3)
transitional care programs; and (4) post-hours telemonitoring.
(1) Healthcare Management
Telehealth has been shown to increase efficiency through better
healthcare management.\41\ MA enrollees who choose telehealth are
better able to manage their conditions through the use of technology
for treatment plan management and medication management. Treatment
often involves changes to the patient's lifestyle, such as weight
management, smoking cessation, and dietary changes. Using technology to
conduct lifestyle counseling remotely makes it more likely that the
provider and patient will work collaboratively on the treatment plan.
---------------------------------------------------------------------------
\41\ Armaignac, Donna Lee, Saxena, Anshul, Rubens, Muni, Valle,
Carlos, Williams, Lisa-Mae, Veledar, Emir, and Gidel, Louis (2018).
``Impact of Telemedicine on Mortality, Length of Stay, and Cost
Among Patients in Progressive Care Units: Experience From a Large
Healthcare System.'' Critical Care Medicine, 46(5): 728-735.
---------------------------------------------------------------------------
(2) Medication Therapy Management (MTM) \42\
---------------------------------------------------------------------------
\42\ Our current MA program allows telemonitoring, hospital
readmission prevention programs, and post-discharge in home
medication reconciliation.
---------------------------------------------------------------------------
Additionally, telehealth can help significantly with patients who
need multiple medications. Remote medication management can reduce the
multiple patient visits often necessary to get the appropriate mix of
medications. One recent meta-study on MTM summarizes seven studies,
showing that using comprehensive medication reviews (the principle
driver of MTM savings) reduced hospitalizations, readmissions, drugs,
and mortality.\43\
---------------------------------------------------------------------------
\43\ Evan A. DeZeeuw, PharmD; Ashley M. Coleman, PharmD; and
Milap C. Nahata, PharmD, MS, ``Impact of Telephonic Comprehensive
Medication Reviews on Patient Outcomes,'' Am J Manag Care.
2018;24(2):e54-e58.
---------------------------------------------------------------------------
[[Page 55057]]
(3) Transitional Care Programs
Telehealth has been used to provide transitional care for
discharged hospital patients. One study found a savings of $1,333 per
beneficiary, half of which was due to reduced inpatient follow-up
care.\44\
---------------------------------------------------------------------------
\44\ Keith Kranker, Ph.D.; Linda M. Barterian, MPP; Rumin
Sarwar, MS; G. Greg Peterson, Ph.D.; Boyd Gilman, Ph.D.; Laura Blue,
Ph.D.; Kate Allison Stewart, Ph.D.; Sheila D. Hoag, MA; Timothy J.
Day, MSHP; and Lorenzo Moreno, Ph.D. ``Rural Hospital Transitional
Care Program Reduces Medicare Spending,'' Am J Manag Care.
2018;24(5):256-260.
---------------------------------------------------------------------------
(4) Post-Hours Telemonitoring
A study reviewing after-hours telemedicine (in which a nurse would
transmit data about patients with a change in condition) reported
savings of $4,000 per skilled nursing facility bed, which translates
into savings of $5 million against a cost of $1 million for
implementing the program.\45\
---------------------------------------------------------------------------
\45\ David Chess, MD; John J. Whitman, MBA; Diane Croll, DNP;
and Richard Stefanacci, DO ``Impact of After-Hours Telemedicine on
Hospitalizations in a Skilled Nursing Facility,'' The Amer. J. of
Manage Care, 24(8), 2018, e54-e56.
---------------------------------------------------------------------------
d. Increased Costs if Unnecessary Medical Visits Increase
There are two primary concerns regarding telehealth savings.\46\
The first concern is that the direct-to-consumer telehealth visits are
more likely to result in follow-up appointments, testing, or
prescriptions. Compared to similar visits to other settings, direct-to-
consumer telehealth could increase spending (by MA plans, providers,
the government, and/or patients). For example, given liability
concerns, direct-to-consumer telehealth physicians may be more likely
to recommend that patients have a subsequent in-person visit with a
provider. Therefore, although the telehealth visit is less costly, the
per-episode cost of a direct-to-consumer telehealth visit could be
greater than that of a visit in other settings.
---------------------------------------------------------------------------
\46\ J. Scott Ashwood, Ateev Mehrotra, David Cowling, and Lori
Uscher-Pines, ``Direct-To-Consumer Telehealth May Increase Access To
Care But Does Not Decrease Spending,'' Health Affairs, Vol. 36, No.
3: Delivery System Innovation, accessible at https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.1130.
---------------------------------------------------------------------------
The second concern is that the convenience of direct-to-consumer
telehealth may drive many patients to seek care for an illness when
they would not have sought care if telehealth had not been available.
Instead of saving money by substitution (that is, replacing more
expensive visits to physician offices or emergency departments),
direct-to-consumer telehealth may increase spending by new utilization
(that is, increasing the total number of patient visits).
To document these concerns, the Health Affairs article cited above
presents a study on commercial health plan enrollees with specific
illnesses. The study showed an increase of $45 per year per telehealth
user. The authors acknowledge that a key attraction of telehealth for
commercial health plans and employers is the potential savings involved
in replacing physician office and emergency department visits with less
expensive virtual visits; however, increased convenience may tap into
unmet demand for health care, and new utilization may increase overall
healthcare spending.
The article acknowledges various limitations of the study: (1) It
applies to commercial health plan enrollees; (2) only one telehealth
company in California was used; (3) the users had a low telehealth
usage, and study results could differ if telehealth becomes more
popular; and (4) only one medical condition was studied (which is
frequently dealt with by telehealth).
The article also mentions various approaches that could be used to
reduce extra costs, for example, increasing cost sharing to prevent
indiscriminate use of telehealth on conditions that one would not
ordinarily see a provider.
In conclusion, although telehealth has a significant potential to
produce savings, this potential is counterbalanced by several factors,
which might reduce these savings or produce increased costs for MA
plans, providers, the government, and/or patients (such as increased
in-person visits and increased utilization patterns). Additionally,
several telehealth services--telemonitoring and remote access
technologies (including web/phone based hotlines)--are allowed under
current guidelines; many MA plans already offer these services as
supplemental benefits.
As regards to the illustrative calculation of a $6 to $10 million
transfer from enrollee to government and a savings to enrollees of $60
to $100 million per year, arising from reduced travel times, we now
summarize the simplifying assumptions below.
First, the transfer from enrollee to government reflects an
assumption that the same number of services will occur, but their
classification will change from supplemental to basic. This simplifying
assumption is certainly contradicted by the expected growth rate in
telemonitoring. However, we have argued above that increased use of
telemonitoring will result in significant healthcare savings due to
prevention of future illnesses. Therefore, a $6 to $10 million estimate
of cost per year may be outweighed by healthcare savings.
Second, the savings of $60 to $100 million per year arising from
reduced travel time to providers reflects several simplifying
assumptions such as applying proportions of telehealth services of
provider visits in the general population to the aged population and
ignoring the current extent of telehealth services in MA plans.
Thirdly, we have disregarded the possible cost impact of telehealth
arising from enrollees indiscriminately using telehealth for provider
services in situations where provider assistance was not previously
sought. As noted previously, this negative effect was found in one
commercial provider on a population with a very low telehealth usage.
Furthermore, there are possible methods to prevent indiscriminate use
of telehealth services. The majority of the articles we cited and
reviewed previously were very positive about health savings and did not
mention increased costs. Therefore, we determined the best approach is
to assume the increased costs from telehealth will not arise.
Fourth, we ignore the current usage of telehealth by MA plans who
may furnish telehealth as a supplemental benefit. Our primary reason
for ignoring this is the lack of adequate data. Other reasons for
ignoring this are that only large plans have listed supplemental
telehealth as a line-item in their bid documentation, and articles
generally show that even where allowed (such as in commercial plans)
telehealth is not used to its full potential.
In light of the information provided previously, all our estimates
of impact should be seen as reasonable first attempts at estimation
with the intent to solicit comments from the industry on their
experiences and whether such assumptions are warranted or should lead
to modifications in our estimates.
There is one additional negligible cost, mentioned in section
III.B.1. of this proposed rule, which arises from the proposed
provision at Sec. 422.135(c)(2) requiring that MA plans advise
enrollees that they may receive the specified Part B service(s) either
through an in-person visit or through electronic exchange. This
notification would appear in the Evidence of Coverage (EOC) document,
which is already required and provided in model form by CMS to MA
plans. There is a one-time cost for CMS staff to formulate the required
template notification language in our EOC model for all plans to adopt
without edit.
We estimate it would take a CMS Central Office staff person 1 hour
to
[[Page 55058]]
produce language for such a model. The typical Central Office employee
is at the GS-13 level. The 2018 wages for the Baltimore area, available
at https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2018/AK_h.pdf, indicate an approximate hourly wage of
$50 (with the Step 3 hourly wage being slightly below and the Step 4
hourly wage being slightly above). We further allow 100 percent for
fringe benefits and overhead costs. Thus, the expected burden to the
federal government is a negligible cost of $100 (1 hour * $50 wage per
hour * 2).
2. Integration Requirements for Dual Eligible Special Needs Plans
(Sec. Sec. 422.2, 422.60, 422.102, 422.107, 422.111, and 422.752)
As stated in the preamble, starting in 2021, section 50311(b) of
the Bipartisan Budget Act of 2018 establishes new Medicare and Medicaid
integration standards for MA organizations seeking to offer D-SNPs and
enrollment sanctions for those MA organizations that fail to comply
with the new standards. We propose to add a revised definition for ``D-
SNP'' at Sec. 422.2 and establish at Sec. 422.107 revisions to the
existing minimum state Medicaid agency contracting requirement for D-
SNPs other than FIDE SNPs and HIDE SNPs, which are also defined at
Sec. 422.2.
As noted in the preamble, many of the changes we are proposing
would unify and streamline existing requirements, which should reduce
burden and are therefore not expected to have impact. For example:
Passive enrollment: The reference to the proposed
definition of a HIDE SNP at Sec. 422.2 would not materially change the
plan types that are eligible for passive enrollment; rather, the
existing rule simply refers to them as the D-SNPs that meet a high
standard of integration under the supplemental benefit authority at
Sec. 422.102(e).
Enhanced Supplemental Benefits: We also propose clarifying
at Sec. 422.102(e) that not only are HIDE SNPs that meet minimum
quality and performance standards eligible to offer supplemental
benefits, but FIDE SNPs that similarly meet minimum quality and
performance standards may do so as well. While this amendment does not
change what has occurred in practice, we believe it clarifies the types
of plans that are eligible to offer enhanced supplemental benefits.
Additional costs were presented in the Collection of Information
(COI) section of this proposed rule. However, the COI made an
assumption which must be modified for purposes of this Regulatory
Impact Analysis (RIA) section: The cost to State Medicaid agencies for
updating their contracts was reduced by 50 percent reflecting the
Federal administrative matching rate for state Medicaid agency
expenditures. This is correct for the COI since federal costs are never
listed in the COI. However, for the purposes of the RIA section they
should be listed. More specifically, the total cost should be listed as
a true cost (that is payment for services and goods) to the state
agencies, half of which is transferred to the federal government. The
simplest way to describe the impact of this provision is simply to redo
the summarizing table in the COI section. The assumptions and sources
underlying the numbers in this table have been presented in the COI
section. This is presented in Table 9.
Table 9 notes which numbers are true savings or costs and which
numbers or parts of estimates are transfers. Since the impacts are for
services such as updating manuals or updating software, the cost and
savings impact are true costs or savings (which in some cases reflect a
transfer to the federal government). Table 9 also notes who bears the
cost (states or MA plans). As can be seen, the aggregate cost of this
provision is a first year cost of $3.4 million, $0.2 million of which
are transfers between the Federal government and states. As noted in
the section, although additional updates may be necessary in future
years, we are scoring this as $0 as a best estimate given uncertainty
regarding the need for additional changes by states and plans after the
first year.
[GRAPHIC] [TIFF OMITTED] TP01NO18.011
[[Page 55059]]
3. Unified Grievance and Appeals Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed Care Plans at the Plan Level
(Sec. Sec. 422.560-562, 422.566, 422.629-634, 438.210, 438.400, and
438.402)
Proposed changes to the appeals and grievances provisions at
Sec. Sec. 422.629 through 422.634 focus on creating MA and Medicaid
appeal and grievances processes that are unified for D-SNPs that also
have comprehensive Medicaid managed care contracts (or are the
subsidiary of a parent organization or share a parent organization with
the entity with a comprehensive Medicaid managed care contract). The
proposal addresses appeals at the plan level. Currently, Medicaid and
MA appeals and grievance processes differ in several key ways. These
differences hinder a streamlined grievance and appeals process across
Medicare and Medicaid managed care sectors and create unnecessary
administrative complexity for plans that cover dual eligible
individuals for both Medicare and Medicaid services. Our proposed
revisions would allow enrollees in a D-SNP that is also a Medicaid
managed care plan through which the enrollees get Medicaid coverage to
better understand the grievance and appeals processes and generally
receive a resolution of their grievances and appeals more quickly.
There are six areas where this provision will have an impact.
Certain Medicare Parts A and B benefits that the D-SNP has
tried to terminate would be provided during the pendency of the
integrated appeal at the plan level. This is estimated in detail below.
The cost to the Medicare Trust Fund and beneficiaries (in the form of
cost sharing) is $0.4 million in 2021 and $0.5 million in 2022-2024,
growing modestly due to expected enrollment growth, to $0.6 or $0.7
million in the next few years.
Applicable integrated plans' grievance policies and
procedures and grievance notices would be updated. As discussed in the
Collection of Information section, there would be a one-time first year
cost of $18,790 for updates of applicable integrated plans' policies
and procedures on grievances and an annual savings of $270,103
reflecting savings from Medicare and Medicaid grievance consolidation).
Thus, there would be an annual savings of $0.3 million.
Notice templates for the unified appeals for use by
applicable integrated plans would be created by CMS, which is estimated
to be a one-time negligible cost of about $1,000 for the work of
Federal employees.
Subregulatory guidance on integrated grievance and appeals
would be developed by CMS staff, which is estimated to be a one-time
negligible cost of about $2,000.
Applicable integrated plans' appeals policies and
procedures and appeals notices would be updated to comply with the
unified appeals requirements, which is estimated to be a one-time
negligible cost of $9,395 (4 hours per contract * 34 contracts *
$69.08, the hourly wage of a business operations specialist).
Enrollees of applicable integrated plans who wish to
receive a copy of their appeal case file would request that plans send
it to them at plan expense, which we estimate to cost about $38,637
annually.
The aggregate cost of this provision is $0.2 million a year.
Industry would save $0.3 million each year in reduced services because
grievances in Medicare and Medicaid are unified. However, this $0.3
million savings would be offset by an increase in cost of $0.5 million
reflecting increased services. The $0.5 million cost (as well as the
0.3 million savings) are ultimately borne by the Medicare Trust Fund in
the form of payments and beneficiaries in the form of increased cost-
sharing.
We present details on these six areas in the sections that follow.
a. Furnishing Medicare Parts A and B Services During the Pendency Of
Appeals
One of the provisions related to appeals integration may marginally
impact the ways MA sponsors bid for their D-SNPs, which could
marginally impact Medicare spending. We propose that the existing
standards for continuation of benefits at Sec. 438.420 apply to
applicable integrated plans for Medicare benefits under Parts A and B
and Medicaid benefits in our proposed integrated appeals requirements
at Sec. 422.632. Under our proposal, and as is applicable to Medicaid
managed care plans currently, if an applicable integrated plan decides
to stop or reduce a benefit that the enrollee is currently authorized
to receive, the enrollee could request that the benefit continue to be
provided at the currently authorized level while the enrollee's appeal
is pending through the integrated reconsideration. Currently, MA plans
in general are not required to provide benefits pending appeal, whereas
in Medicaid it has been a long-standing feature.
It is our expectation that the new integrated appeals provisions
will result in an increase in expenditures by applicable integrated
plans for Medicare covered services because they will be required to
continue coverage for services during the pendency of the
reconsideration request, or first-level appeal under our proposal.
The estimate of impact of this continuation is based on calendar
year (CY) 2016 appeal metrics, which are then trended to CY 2021.
The assumptions, sources and calculations are summarized in Tables
G5 and G6 in this rule and further clarified as follows.
The first step in this estimation is to determine the number of
applicable reconsiderations per 1,000 beneficiaries enrolled in
integrated plans affected by this provision. Given the similarity of
population characteristics, the reconsideration experience for the
Medicare-Medicaid Plans (MMPs) participating in the Financial Alignment
Initiative was used as a proxy for the applicable integrated plans. In
2016, MMP enrollees were impacted by 1,232 reconsiderations for
services which were resolved adversely or partially favorably to the
beneficiary. The corresponding MMP enrollment in 2016 was 368,841,
which implies a rate of 3.3 applicable reconsiderations per 1,000 in
2016.
Then we projected D-SNP enrollment impacted by the unified
procedures to grow from 150,000 in 2018 to 172,000 (150,000 * 1.145) in
2021 based on the estimated enrollment growth for all D-SNPs during the
period of 14.5 percent. Applying the MMP appeal rate of 3.3 per 1,000
to the projected 2021 enrollment in applicable integrated plans of
172,000 results in an estimated 568 (172,000 * 3.3/1,000) service
reconsiderations for the applicable integrated plans in 2020.
The next step is to determine the average level of benefit subject
to the appeals. Table 1 in the report Medicare Part C QIC
Reconsideration Data for 2016 \47\ contains data on the number and
benefit amounts by service category for the second level appeals filed
in 2016. Analysis of these data resulted in an estimated per-appeal
benefit value of $737 for 2016. The determination of this value took
into account that some services would not be subject to the regulatory
extension of coverage due to the existence of immediate review rights
(inpatient hospital, skilled nursing facility, and home health), other
benefits would likely have been rendered already (emergency room, and
ambulance), and other services are not
[[Page 55060]]
covered as a D-SNP basic benefit (hospice and non-Medicare benefits).
Accounting for 19.5 percent inflation in per-capita Medicare spending
between 2016 and 2021, and carving out the 13.38 percent consumer price
index inflation in years 2016--2020 inclusive, results in an estimated
per-appeal benefit value of $774 (that is, $737 * 1.195/1.1338) for
2021.
---------------------------------------------------------------------------
\47\ https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/IRE.html.
---------------------------------------------------------------------------
Taking the product of the number of applicable integrated plan
service reconsiderations in 2021 (568) and average benefit value in
2021 ($774) yields an estimated cost in 2021 of $439,632 (that is, 568
* $774) due to an increase in Medicare expenditures stemming from the
unified appeals procedures for applicable integrated plans. We believe
that this figure represents an upper bound of the cost given that not
all applicable services will be rendered during the extended period of
benefit continuation being proposed in this regulation. These
calculations are summarized in Table 10.
Using the 2021 estimates as a basis, estimates for 2021 through
2029 are presented in Table 11. The following assumptions were used in
creating Table 11:
As described earlier in this section, the numbers in the
row for 2021 come from Table 10.
The projected FIDE SNP enrollment for 2022 through 2029
was obtained by multiplying the estimated 2021 FIDE SNP enrollment of
172,000, using SNP enrollment growth factors inferred from Table IV.C1
in the 2018 Trustees Report.
The projected cost per appeal for 2022 through 2029 was
obtained by first multiplying the estimated 2021 cost per appeal of
$774 by FFS per capita growth rates obtained from internal
documentation for the Table of FFS USPCC, non-ESRD estimates in
attachment II of the 2019 Rate Announcement and Call Letter (https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf).
The results are summarized in Table 11. As can be seen, there is an
estimated true cost (reflecting purchase of goods and services) of $0.4
million in 2021 and $0.5 million in 2022 through 2024. Eighty-six
percent of this cost is transferred from the plans to the Medicare
Trust Fund. The remainder of this cost is born by beneficiary cost
sharing. The cost of appeals between 2025 and 2029 is $0.5 to 0.6
million for the Medicare Trust Fund and $0.1 million for beneficiaries.
BILLING CODE 4120-01-P
[[Page 55061]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.012
[[Page 55062]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.013
b. Updating Plan Grievance Policies and Procedures and Consolidation of
Plan Notifications
As detailed in the Collection of Information section of this
proposed rule, there are only 34 contracts representing 37 D-SNPs that
we currently believe would be classified as a HIDE SNP or FIDE SNP and
operate in states that have policies requiring exclusively aligned
enrollment across MA and Medicaid managed care plans. The analysis
presented in the Collection of Information section for unified
grievance and appeals estimates initial one-time cost of $18,790 and
$8,374 and annual savings, due to reduction of notifications, of
$270,103. Thus, the annual savings is $0.2 million in the first year
and $0.3 million annually thereafter.
c. Creation of New Grievance and Appeal Notice Templates
When MA plans send out notifications to enrollees, they usually
have the option to use templates created by CMS. To address the
proposed new unified grievance and appeal procedures, CMS Central
Office staff must create new notice templates. We estimate that three
new notice templates must be created. We estimate each new template
will require 3 hours of work by a GS level 13, step 5 (GS-13-5),
employee. The 2018 hourly wages for a GS-13-5 Federal employee is
$52.66.\48\ We allow 100 percent for Fringe Benefits and overtime. Thus
the expected one-time negligible initial cost is $1,000 (actually, $948
= 3 templates * 3 hours per template * $52.66 hourly wage * 2 for
overtime and fringe benefits).
---------------------------------------------------------------------------
\48\ https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2018/DCB_h.pdf.
---------------------------------------------------------------------------
d. Subregulatory Guidance in CMS Manuals on the New Grievance and
Appeals Procedures
The CMS manuals present comprehensive sub-regulatory guidance on
regulatory matters. Since these unified grievance and appeals
procedures are new, we estimate it would require 20 hours to develop
subregulatory guidance to be published in the CMS Medicare managed care
manual. Thus we expect a negligible one-time cost of $2,000 (actually
$2,106 = 20 hours of work * $52.66, hourly wage for a GS-13-5 * 2 for
overtime and fringe benefits).
e. Updating Applicable Integrated Plan Appeals Policies and Procedures
Applicable integrated plans' internal appeals policies and
procedures must be updated to comply with the unified appeals
requirements. In terms of updates, we see no reason to differentiate
between the work required for grievances and appeals. Using our
estimate for grievance procedures, we estimate for appeals an initial
one-time negligible cost of $9,395 (that is, 4 hours per contract * 34
contracts * $69.08, the hourly wage of a business operations specialist
including 100 percent for fringe benefits and overhead).
f. Sending Appeal Files to Enrollees Who Request Them
Medicaid managed care regulations currently require plans to send,
for free, appeal case files to enrollees who appeal while, in contrast,
MA regulations require sending such files at a reasonable cost. Our
proposal would require the applicable integrated plans to send such
files for free. To estimate this cost, we must first estimate the cost
of sending such a file.
Livanta,\49\ a Quality Improvement Organization, estimates the cost
per case file as $40-$100. This can be justified independently with a
stricter range as follows: Assuming a typical case file has 100 pages,
it would weigh about 1 pound at 6 pages per ounce. The cost of mailing
a 1-pound case file by FedEx (to assure security) is $10. The cost of
photocopying 100 pages at a minimum rate of $0.05 per page is $5. The
$0.05 per page is likely to be an overestimate for plans that own their
own photocopying equipment. Thus, the total cost of photocopying and
mailing would be about $15. We assume a correspondence clerk, BLS
occupation code 43-4021,\50\ would take 1 hour of work, at $36.64 per
hour (including 100 percent for overtime and fringe benefits) to
retrieve the file, photocopy it, and prepare it for mailing. Thus we
estimate the total cost at $36.64 + $10 + $5 = $51.64.
---------------------------------------------------------------------------
\49\ https://bfccqioareal.com/recordrequests.html.
\50\ https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------
We need further estimates to complete the calculation. We assume
43.5 total appeals (favorable and unfavorable) per 1000.\51\ Based on
our experience, we assume that 10 percent of all appeals would require
a file sent. Finally, as indicated in the Collection of Information
section, there are 37 D-SNPS in 34 contracts with 150,000 enrollees in
2018 projected to grow to 172,000 enrollees in 2021. Thus we estimate
the total annual cost of mailing files to enrollees as $38,637 (that
is, 172,000 enrollees * 4.35 percent appeals
[[Page 55063]]
* 10 percent requesting files * $51.64 cost).
---------------------------------------------------------------------------
\51\ https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/PartCDDataValidation.html.
---------------------------------------------------------------------------
In conclusion, the primary driver of costs of this provision are
the effects on the Medicare Trust Fund and beneficiary cost sharing
presented in Tables G5 and G6. These costs are offset by annual savings
of $0.3 million due to unification of grievance procedures. Other costs
are considered negligible (below a $50,000 threshold for E.O. 13773
accounting). A summary by year is presented in Table 12.
[GRAPHIC] [TIFF OMITTED] TP01NO18.014
We note that these costs and savings are true costs and savings
since they reflect payment for additional or fewer economic resources
(reduced notifications and increased appeals). The increased appeals
costs are a cost to MA plans, which transfer this cost to enrollees and
the Medicare Trust Fund (the government).
4. Proposal for Prescription Drug Plan Sponsors' Access to Medicare
Parts A and B Claims Data Extracts (Sec. 423.153)
As described in section II.A.3. of this proposed rule, section
50354 of the Bipartisan Budget Act of 2018 requires the establishment
of a process under which the sponsor of a PDP that provides
prescription drug benefits under Medicare Part D may request, beginning
in plan year 2020, that the Secretary provide on a periodic basis and
in an electronic format standardized extracts of Medicare claims data
about its plan enrollees. In this rule we propose to add a new Sec.
423.153(g) to implement the process for requesting these data.
To estimate the impact we require a model of operationalizing this
provision, without however committing to a particular operationalizing
process. We outline a process which--
Meets all regulatory requirements; and
Requires as little burden as possible to make and grant
requests.
We solicit comments from stakeholders on this proposed
operationalization.
Electronic request and transfer are superior (have less burden)
than paper processes. We could therefore add functionalities to the CMS
HPMS system (or other CMS systems) which would allow the following
functions:
Request of claims data for the current and future quarters
for enrollees of the PDP requesting the data.
Request to no longer receive data.
Attestation that all regulatory requirements will be
complied with. The attestation would be in the form of a screen listing
all regulatory requirements; the authorized PDP HPMS user would have to
electronically attest by clicking a button.
Such a process would combine request and attestation. The receipt of
the submission would verify completeness of request. Furthermore, there
would be no burden in request (under 1 minute of work).
The HPMS contractors estimate that this would be a one-time update
costing approximately $200,000.
Besides requesting the data, data must be transmitted to the
requesting sponsor. Ideally, data would be transmitted electronically
but we do not yet have such an API. Instead, we would treat requested
data like data requested for research. Typically, such data is
downloaded onto hard drives and mailed to requestors.
The data could come from the Chronic Condition Warehouse (CCW). We
asked our contractors the cost of downloading quarterly such data and
sending it out. The cost varies by sponsor size. Currently, based on
CMS public data, there are 63 PDP sponsors. Their size and the
quarterly cost per sponsor of providing them with data, should they
request it, is summarized in Table 13.
[[Page 55064]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.015
To complete the annual impact analysis we need an estimate of
proportions for each plan size that would request data. For example, we
are certain that the 1 PDP sponsor with over 5 million enrollees will
request data. Thus the annual burden for that plan size is 1 * 4
quarters X $26,500 per quarter = $106,000. Similarly, if we assume that
all six PDP sponsors with enrollments between 1 and 5 million would
request data then the annual burden is 6 sponsors * 4 quarters *
$17,500 per quarter per sponsor = $420,000. If we assume that only
three-quarters of these six sponsors request data then the annual
burden would be 0.75 * $420,000 = $315,000. In the absence of any other
basis for the decision, it is reasonable to assume that the proportion
goes down as the size goes down. In the absence of data, we could use a
descent of simple fractions (1, three-fourths, one-half, one-fourth).
Note, that 50 percent of plans with under 100,000 enrollees have under
10,000 enrollees. It is very unlikely that such plans would have the
resources to use the data. Thus an assumption that only 50 percent of
plans under 100,000 request data is reasonable. However, we consider
multiple scenarios. Table 14 presents for a variety of scenarios of
proportions and their total impact. The average of the five scenarios
is $1.5 million while the median is $1.3 million. The range of impacts
is $0.8 million-$2.9 million. For purposes of E.O. 13771 accounting we
are listing the impact as $1.5 million annually, with a $0.2 million
one-time cost in the first year. We do not trend this estimate by year
since the number of PDP sponsors has remained at 63 since 2015.
[GRAPHIC] [TIFF OMITTED] TP01NO18.016
BILLING CODE 4120-01-C
We do not anticipate any further burden. It is most likely that the
PDP sponsor would exclusively use the data. In the event that
downstream entities are shared any data they are already bound in their
contracts by all Medicare regulations including the regulations of this
provision. Even if there would be a need to modify contracts to address
the regulatory requirements of using such data, it would require at
most one hour of work of a GS-12 or GS-13 staff member and one hour of
review by a GS-15. A total of 2 hours of work by Federal employees
would have a burden significantly less than $1,000. Hence, we are not
further scoring this negligible impact.
5. Medicare Advantage and Part D Prescription Drug Plan Quality Rating
System (Sec. Sec. 422.162(a) and 423.182(a), Sec. Sec. 422.166(a) and
423.186(a), Sec. Sec. 422.164 and 423.184, and Sec. Sec.
422.166(i)(1) and 423.186(i)(1))
We are proposing some measure specification updates. These type of
changes are routine and do not have an impact on the highest ratings of
contracts (that is, overall rating for MA-PDs, Part C summary rating
for MA-only contracts, and Part D summary rating for stand-alone
prescription drug plans). Hence, there will be no, or negligible,
impact on the Medicare Trust Fund.
We are also proposing some adjustments for disasters. The proposed
policy would make adjustments to take into account the potential impact
on contracts when there are extreme and uncontrollable circumstances
affecting them. This policy is in response to the multiple disasters in
2017 and 2018, including several hurricanes and wildfires. We are
proposing a policy to permit an adjustment to Star Ratings when extreme
and uncontrollable circumstances occur during the performance period or
measurement period for MA and Part D plans.
We are also proposing enhancements to the current methodology to
set Star Ratings cut points. The intent of the changes is to increase
the stability and predictability of cut points from year to year. This
proposal is consistent with the CMS goal to increase transparency. We
believe this provision would also have minimal impact on the highest
ratings of contracts. Specifically, simulations of the proposal using
the 2018 Star Ratings show that the QBP
[[Page 55065]]
ratings overall would increase for less than 1 percent of MA enrollees.
6. Improving Clarity of the Exceptions Timeframes for Part D Drugs
(Sec. Sec. 423.568, 423.570, and 423.572)
We are proposing to limit the amount of time an exception request
can be held open to 14 calendar days, meaning that there will be an
outside limit to how long the request is in a pending status while the
Part D plan sponsor attempts to obtain the prescribing physician's or
other prescriber's supporting statement. Under current manual guidance,
plan sponsors are instructed that an exception request should only be
held open for a reasonable period of time if a supporting statement is
needed. We believe that no more than 14 calendar days is a reasonable
period of time to have an exception request open and this proposal
seeks to codify that standard. We do not expect this proposal to have
any new impact on the number of pending appeals or pose a potential
burden to plan sponsors, as we expect plans are already making and
notifying enrollees of decisions on exception requests under a similar
reasonable timeframe. Based on findings from plan sponsor audits, this
proposed timeframe is generally consistent with how plans sponsors have
operationalized the current standard that cases only be held open for a
reasonable period of time pending receipt of a prescriber's supporting
statement. Therefore, we do not expect that plan sponsors would need to
hire more staff or adjust their operations in a manner that would
affect costs. Consequently, we expect the impact of this proposed
requirement to be negligible.
7. Preclusion List Requirements for Prescribers in Part D and
Individuals and Entities in MA, Cost Plans, and PACE (Sec. Sec.
422.222 and 423.120(c)(6))
We do not anticipate any additional cost or savings associated with
our proposed preclusion list provisions. As we indicated in section
III. of this proposed rule, the proposed provisions would not involve
activities for plan sponsors and MA organizations outside of those
described in the April 2018 final rule. Our proposed provisions are,
generally speaking, clarifications of our intended policy and do not
constitute new requirements. Hence, the expected impact is negligible.
8. Medicare Advantage Risk Adjustment Data Validation Provisions
(Sec. Sec. 422.300, 422.310(e), and 422.311(a))
a. Proposals
This proposed rule would create regulations to govern the
collection of extrapolated audit findings. As CMS develops its approach
to statistical sampling and extrapolation, it is taking account of the
recommendations of the 2016 General Accounting Office (GAO) report on
CMS audit practices.\52\ For example, CMS has been randomly selecting
30 plans for audit based on factors unrelated to payment error. In
recent years, only half of those audited plans have had findings; the
other half have had no net findings of improper payments. The GAO has
recommended that CMS select plans that historically have high error
rates either from the National audits as published in the Report of the
Chief Financial Officer or from prior CMS audits. This recommendation
would probably increase the number of findings, and hence the amount
collected through the audits. CMS has accepted all GAO findings and
intends to develop its sampling and extrapolation methodology
consistent with them.
---------------------------------------------------------------------------
\52\ https://www.gao.gov/products/GAO-16-76.
---------------------------------------------------------------------------
To clarify in more detail how the proposed rules would impact the
recovery audit process we note the following facts:
RADV recovery for payment years 2011, 2012, and 2013
included 30 MA contracts per payment year. For each contract, 200
enrollees have been selected. The aggregate cost to the government for
each audit is $54 million.
National audits are for the purpose of payment error
measurement in the Part C program. A nationally representative sample
of 600 enrollees are selected from approximately 200 plans. Each plan
contributes between 1 to 15 enrollees with many plans contributing
under 10 enrollees. The annual cost to the government of a national
audit is between $6 to 10 million. No recovery is made through the
national audits.
Findings from the national and contract-level audits will
be used to predict beneficiaries at most risk for improper payment. CMS
will use these estimates to target plans at most risk for improper
payment for RADV audit.
By better targeting audits to improper payment, CMS
expects any sentinel effect of RADV to continue to reduce the
historical Part C error rate.
b. Expected Impact of These Provisions
While we cannot fully estimate the quantitative impact of this
provision, we can clearly identify certain components of impact. We
start with some basic facts mentioned in the preceding narrative.
With extrapolated audit findings, we would realize a
positive ROI. The cost per year for a RADV audit is $54 million. Non-
extrapolated recoveries would result in a $10 to 15 million collection
per audit.
Extrapolating audit findings does not increase the cost
burden on the plan. The cost to the plan of complying with a RADV audit
is neither the subject of nor affected by this provision. This
provision addresses recovering extrapolated or non-extrapolated audit
findings. While extrapolation does increase the level of the audit
recovery, because returning improper payments is not a cost, the
decision to extrapolate does not impact the cost to the plan.
The audits for payment years 2011, 2012, and 2013 suggest
that audited MA contracts received $650 million in of improper payments
in those 3 years.
This $650 million would be a transfer from the government
to insurers since money paid for human coding error which CMS paid the
contracts to pay their providers is no longer being done, meaning that
the contracts must take responsibility for the improper provider
payments.
These audits cover 3 years, with 30 contracts audited each
year.
Roughly half the contracts each year had no net findings
of improper payments.
Using these data we can conclude as follows:
The audits for payment years 2011, 2012, and 2013 suggest
that audited MA contracts were responsible for $650 million of improper
payments in those 3 years.
$650 million divided by 3 audit years is $217 million per
audit year.
$217 million per audit year divided by 15 contracts with
audit findings per year is $14.5 million per contract with audit
findings per year.
If GAO recommendations are adopted which would facilitate
focusing on contracts with expected findings, and the level of audit
findings holds constant, then $14.5 million per contract with audit
findings per year times 30 contract with audit findings per year would
produce $435 million in audit collections per year.
This level of recovery would produce $381 million in
aggregate savings per year (that is, $435 million - $54 million, since
the cost of audits would remain at $54 million).
This numerical bulleted argument is summarized in Table 15.
It might seem natural to trend the $381 million based on non-
inflation factors. The following considerations argue against trending.
Therefore, we are leaving the estimate of dollar savings
[[Page 55066]]
to the Medicare Trust Fund at $381 million per year at each year for
the next 10 years with an additional $650 million the first year. A 10-
year table is presented in Table 16. The arguments against trending are
the following:
The error rate of improper payments per year, as indicated
in the reports of the Chief Financial Officer have been declining and
are likely to continue to decline. Importantly, although we have about
10 years of data we have insufficient data to extrapolate since
performance error is rarely linear. Thus trending would involve non-
linear functions and would require more data.
The aggregate amount paid to contracts is increasing due
to enrollment growth. The Office of the Actuary at CMS annually
publishes a Trustee Report which contains projected enrollment.\53\
---------------------------------------------------------------------------
\53\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/index.html.
---------------------------------------------------------------------------
The $381 million is based on current error rates and
enrollment growth. But we have already indicated that 50 percent of
contracts audited had no net audit findings. We have already indicated
that acceptance of GAO recommendations would facilitate targeting
contracts with higher rates and have therefore assumed there would be
findings in all 30 contracts audited.
For these reasons, we are leaving the annual estimate as a dollar
savings to the Medicare Trust Fund of $381 million for 2021 and future
years, and a dollar savings of $1.03 billion to the Medicare Trust Fund
in 2020 ($381 million savings per year plus an estimated $650 million
in audit recoveries for payment years 2011 through 2013). All other
things being equal, the increase in enrollment will cause the nominal
dollars in error to increase. The historical decline in the error rate
may or may not offset the increase due to increasing enrollment making
a projection difficult. For this reason we hold the estimate of $381
million constant in the projection.
A table of collection for 10 years is summarized in Table 16.
BILLING CODE 4120-01-P
[[Page 55067]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.017
BILLING CODE 4120-01-C
The estimated 10-year dollar savings to the Medicare Trust Fund
could be $4.5 billion ($381 million per year * 10 years + initial $650
million recovery).
The savings come from recovered inaccurate payments of $381 million
a year by the Medicare Trust Fund to plans. This money is a reduction
in spending of the Medicare Trust Fund (to the plans); there will be no
money transferred to enrollees. We expect that ultimately this
provision could incentivize plans to submit more accurate risk-
adjustment data.
The intent of this rule is to continue the sentinel effect on the
reduction of the Part C error rate. The decline in the Part C error
rate has correlated with the announcement of the agencies intent to use
extrapolated recoveries on payment years 2011 through 2013. We believe
that forgoing the extrapolation on those audits would diminish the
agency's credibility going forward and consequently reduce the sentinel
effect. The dollar savings to the Medicare Trust Fund are presented in
Table 16. In any case, RADV audits will still continue.
[[Page 55068]]
D. Alternatives Considered
1. Requirements for Medicare Advantage Plans Offering Additional
Telehealth Benefits (Sec. Sec. 422.100, 422.135, 422.252, 422.254, and
422.264)
Section 1852(m)(2)(A)(i) of the Act, as added by the Bipartisan
Budget Act of 2018, defines additional telehealth benefits as services
that are identified for the applicable year as clinically appropriate
to furnish using electronic information and telecommunications
technology when a physician (as defined in section 1861(r) of the Act)
or practitioner (described in section 1842(b)(18)(C) of the Act)
providing the service is not at the same location as the plan enrollee
(which we refer to as ``through electronic exchange''). We considered
various alternative definitions of ``clinically appropriate'' but
decided not to propose specific regulation text defining the term. We
are proposing to implement the statutory requirement for additional
telehealth benefits to be provided only when ``clinically appropriate''
to align with existing CMS rules for contract provisions at Sec.
422.504(a)(3)(iii), which requires each MA organization to agree to
provide all benefits covered by Medicare ``in a manner consistent with
professionally recognized standards of health care.''
The statute does not specify who or what entity identifies the
services for the year. We considered various alternatives, including
retaining the authority as an agency to specify what services are
clinically appropriate to furnish each year. MA plans could have been
required to comply with an annual list of clinically appropriate
services identified by CMS. However, we rejected this alternative as
too restrictive; we believe MA plans are in the best position and it is
in their own interest to stay abreast of professional standards
necessary to determine which services are clinically appropriate. Thus,
we are proposing to interpret this provision broadly by not specifying
the Part B services that an MA plan may offer as additional telehealth
benefits for the applicable year, but instead allowing MA plans to
independently determine which services each year are clinically
appropriate to furnish in this manner. Our proposed definition of
additional telehealth benefits at Sec. 422.135(a) provides that it is
the MA plan (not CMS) that identifies the appropriate services for the
applicable year.
We also considered alternatives to implement how telehealth
benefits are provided through ``electronic exchange.'' CMS considered
defining the specific means of ``electronic exchange.'' However, we
decided to define ``electronic exchange'' at Sec. 422.135(a) as
``electronic information and telecommunications technology,'' as the
former is a concise term for the latter, which is the statutory
description of the means used to provide the additional telehealth
benefits. We are not proposing specific regulation text that defines or
provides examples of electronic information and telecommunications
technology. We considered providing a complete list of means of
providing electronic information and telecommunications technology.
Although we provided examples of electronic information and
telecommunications technology in the preamble, we did not provide a
comprehensive list because the technology needed and used to provide
additional telehealth benefits will vary based on the service being
offered. We believe this broad approach will avoid tying the authority
in the proposed new regulation to specific information formats or
technologies that permit non-face-to-face interactions for furnishing
clinically appropriate services.
2. Integration Requirements for Dual Eligible Special Needs Plans
(Sec. Sec. 422.2, 422.60, 422.102, 422.107, 422.111, and 422.752)
We propose to require D-SNPs that--(1) do not meet the HIDE SNP or
FIDE SNP integration standard; and (2) do not have a parent
organization assuming clinical and financial responsibility for
Medicare and Medicaid benefits to notify the state Medicaid agency or
its designee when a high-risk full-benefit dual eligible enrollee has a
hospital or skilled nursing facility admission. We considered several
alternatives to this proposal, as explained in section II.A.2.a.(2). of
this rule, including examples provided in the Bipartisan Budget Act of
2018: Notifying the state in a timely manner of enrollees' emergency
room visits and hospital or nursing Home discharges; assigning each
enrollee a primary care provider; and data sharing that benefits the
coordination of items and services under Medicare and Medicaid.
However, we believe our proposal is preferable to the alternatives when
considering the degree to which it meets our criteria of--(1)
meaningfully improving care coordination and care transitions and
health outcomes for dually eligible beneficiaries; (2) minimizing
burden on plans and states relative to the improvements in care
coordination and transitions; (3) providing flexibility to state
Medicaid agencies; (4) enabling CMS to assess compliance with minimal
burden on CMS, plans, and providers; and (5) adhering to the letter and
spirit of the Bipartisan Budget Act of 2018. However, we soliciting
comment on these alternatives.
3. Unified Grievance and Appeals Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed Care Plans at the Plan Level
(Sec. Sec. 422.560, 422.562, 422.566, 422.629 through 422.634,
438.210, 438.400, and 438.402)
We propose to create unified grievance and appeals procedures for
certain D-SNPs (FIDE SNPs and HIDE SNPs) with exclusively aligned
enrollment, which we propose defining as occurring when such a D-SNP
limits enrollment to full-benefit dual eligible individuals whose
Medicaid benefits are covered by the D-SNP itself, or by a Medicaid
managed care organization that is the same organization, the D-SNP's
parent organization, or another entity that is owned and controlled by
the D-SNP's parent organization. Because most D-SNP enrollees are not
enrolled in D-SNPs with exclusively aligned enrollment, we considered
the feasibility of broadening the scope of these unified procedures to
apply to more D-SNPs--that is, to D-SNPs without exclusively aligned
enrollment. However, in most states, the majority of D-SNP enrollees
have Medicaid coverage either through a different organization's
Medicaid MCO, in a prepaid ambulatory or inpatient health plan (PAHP or
PIHP), or through a state's Medicaid fee-for-service system. In these
circumstances, the D-SNP has no control over the Medicaid grievance and
appeals process. Even a D-SNP that has a Medicaid managed care
organization operated by such plan's parent organization available to
its enrollees, but whose members may instead enroll in other Medicaid
plans, can only unify the procedures for Medicaid appeals and
grievances of those enrollees who are also simultaneously enrolled in
the Medicaid managed care organization controlled by such plan's parent
organization. Therefore, we do not believe that it is feasible at this
time to implement fully unified grievance and appeals systems for D-
SNPs and Medicaid managed care plans that do not have the same
enrollees or where the organizations offering the D-SNPs and Medicaid
plans are unaffiliated or even competitors.
E. Accounting Statement and Table
The following table summarizes costs, savings, and transfers by
provision.
As required by OMB Circular A-4 (available at https://
[[Page 55069]]
obamawhitehouse.archives.gov/omb/circulars_a004_a-4/), in Table 17, we
have prepared an accounting statement showing the savings and transfers
associated with the provisions of this proposed rule for calendar years
2020 through 2029. Table 17 is based on Tables 18A and B which lists
savings, costs, and transfers by provision.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP01NO18.018
The following Table 18 summarizes savings, costs, and transfers by
provision and formed a basis for the accounting table. For reasons of
space, Table 18 is broken into Table 18A (2020 through 2024) and Table
18B (2025 through 2029). In these tables savings are indicated as
negative numbers in columns marked savings while costs are indicated as
positive numbers in columns marked costs. Transfers may be negative or
positive with negative numbers indicating savings to the Medicare Trust
Fund and positive numbers indicating costs to the Medicare Trust Fund.
All numbers are in millions. The row ``aggregate total by year'' gives
the total of costs and savings for that year but does not include
transfers. Tables 18A and B form the basis for Table 16 and for the
calculation to the infinite horizon discounted to 2016 and mentioned in
the conclusion.
[[Page 55070]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.019
[[Page 55071]]
[GRAPHIC] [TIFF OMITTED] TP01NO18.020
BILLING CODE 4120-01-C
[[Page 55072]]
F. Conclusion
As indicated in Table 17, we estimate that this proposed rule
generates net annualized cost of approximately $2 million per year over
2020 through 2029. As discussed in the narrative of this Regulatory
Impact Section, the Medicare Trust Fund is expected, over the next 10
years, to have an aggregate reduction in dollars spent of $4.5 billion
arising from recovery of incorrect payments to plans.
G. Reducing Regulation and Controlling Regulatory Costs
The Department believes that this proposed rule, if finalized, is
considered a deregulatory action under Executive Order 13771. The
Department estimates that this rule generates $1.5 million in
annualized costs at a 7-percent discount rate, discounted relative to
2016, over a perpetualtime horizon.
List of Subjects
42 CFR Part 422
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Medicare, Penalties, Privacy, and
Reporting and recordkeeping requirements.
42 CFR Part 423
Administrative practice and procedure, Emergency medical services,
Health facilities, Health maintenance organizations (HMO), Health
professionals, Medicare, Penalties, Privacy, and Reporting and
recordkeeping requirements.
42 CFR Part 438
Grant programs--health, Medicaid, Reporting and recordkeeping
requirements.
42 CFR Part 498
Administrative practice and procedure, Health facilities, Health
professions, Medicare, and Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend CFR chapter IV as set forth
below:
PART 422--MEDICARE ADVANTAGE PROGRAM
0
1. The authority citation for part 422 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Section 422.2 is amended--
0
a. By adding definitions of ``Aligned enrollment'' and ``Dual eligible
special needs plan'' in alphabetical order;
0
b. By revising the definition of ``Fully integrated dual eligible
special needs plan'';
0
c. By adding the definition of ``Highly integrated dual eligible
special needs plan'' in alphabetical order; and
0
d. In the definition of ``Preclusion list'' by revising the
introductory text and paragraphs (1)(i), (2)(i), (2)(ii)(C) and adding
paragraph (3).
The additions and revisions read as follows:
Sec. 422.2 Definitions.
* * * * *
Aligned enrollment refers to the enrollment in a dual eligible
special needs plan of full-benefit dual eligible individuals whose
Medicaid benefits are covered by such plan or by a Medicaid managed
care organization, as defined in section 1903(m) of the Act, that is
the same organization, its parent organization, or another entity that
is owned and controlled by its parent organization. When State policy
limits a dual eligible special needs plan's membership to individuals
with aligned enrollment, this condition is referred to as exclusively
aligned enrollment.
* * * * *
Dual eligible special needs plan or D-SNP means a specialized MA
plan for special needs individuals who are entitled to medical
assistance under a State plan under XIX of the Act that provides, as
applicable, and coordinates the delivery of Medicare and Medicaid
services, including long-term services and supports and behavioral
health services, for individuals who are eligible for such services.
Such a plan must have a contract with the State Medicaid agency
consistent with Sec. 422.107 that meets the minimum requirements in
Sec. 422.107(c); and, beginning January 1, 2021, must satisfy one or
more of the following criteria for the integration of Medicare and
Medicaid benefits:
(1) Meets the additional requirement specified in Sec. 422.107(d)
in its contract with the State Medicaid agency;
(2) Is a highly integrated dual eligible special needs plan; or
(3) Is a fully integrated dual eligible special needs plan.
* * * * *
Fully integrated dual eligible special needs plan means a dual
eligible special needs plan--
(1) That provides dual eligible individuals access to Medicare and
Medicaid benefits under a single entity that holds both an MA contract
with CMS and a Medicaid managed care organization contract under
section 1903(m) of the Act with the applicable State;
(2) Whose capitated contract with the State Medicaid agency
includes coverage of specified primary care, acute care, behavioral
health, and long-term services and supports, consistent with State
policy, and provides coverage of nursing facility services for a period
of at least 180 days during the plan year;
(3) That coordinates the delivery of covered Medicare and Medicaid
services using aligned care management and specialty care network
methods for high-risk beneficiaries; and
(4) That employs policies and procedures approved by CMS and the
State to coordinate or integrate beneficiary communication materials,
enrollment, communications, grievance and appeals, and quality
improvement.
* * * * *
Highly integrated dual eligible special needs plan means a dual
eligible special needs plan offered by an MA organization that also
has, or whose parent organization or another entity that is owned and
controlled by its parent organization has, a capitated contract with
the Medicaid agency in the State in which the dual eligible special
needs plan operates that includes coverage of long-term services and
supports, behavioral health services, or both, consistent with State
policy.
* * * * *
Preclusion list means a CMS compiled list of individuals and
entities that--
(1) * * *
(i) The individual or entity is currently revoked from Medicare for
a reason other than that stated in Sec. 424.535(a)(3) of this chapter.
* * * * *
(2) * * *
(i) The individual or entity has engaged in behavior, other than
that described in Sec. 424.535(a)(3) of this chapter, for which CMS
could have revoked the individual or entity to the extent applicable
had they been enrolled in Medicare.
(ii) * * *
(C) Any other evidence that CMS deems relevant to its
determination; or
(3) The individual or entity, regardless of whether they are or
were enrolled in Medicare, has been convicted of a felony under federal
or state law within the previous 10 years that CMS deems detrimental to
the best interests of the Medicare program. Factors that CMS considers
in making such a determination under this paragraph (3) are:
(i) The severity of the offense;
(ii) When the offense occurred; and
(iii) Any other information that CMS deems relevant to its
determination.
* * * * *
[[Page 55073]]
0
3. Section 422.60 is amended by revising paragraph (g)(2)(i) to read as
follows:
Sec. 422.60 Election process.
* * * * *
(g) * * *
(2) * * *
(i) Operate as a fully integrated dual eligible special needs plan
or highly integrated dual eligible special needs plan.
* * * * *
0
4. Section 422.100 is amended by revising paragraphs (a) and (c)(1) to
read as follows:
Sec. 422.100 General requirements.
(a) Basic rule. Subject to the conditions and limitations set forth
in this subpart, an MA organization offering an MA plan must provide
enrollees in that plan with coverage of the basic benefits described in
paragraph (c)(1) of this section (except that additional telehealth
benefits may be, but are not required to be, offered by the MA plan)
and, to the extent applicable, supplemental benefits as described in
paragraph (c)(2) of this section, by furnishing the benefits directly
or through arrangements, or by paying for the benefits. CMS reviews
these benefits subject to the requirements of this section and the
requirements in subpart G of this part.
* * * * *
(c) * * *
(1) Basic benefits are all items and services (other than hospice
care or coverage for organ acquisitions for kidney transplants) for
which benefits are available under parts A and B of Medicare, including
additional telehealth benefits offered consistent with the requirements
at Sec. 422.135.
* * * * *
0
5. Section 422.102 is amended by revising paragraph (e) introductory
text to read as follows:
Sec. 422.102 Supplemental benefits.
* * * * *
(e) Supplemental benefits for certain dual eligible special needs
plans. Subject to CMS approval, fully integrated dual eligible special
needs plans and highly integrated dual eligible special needs plans
that meet minimum performance and quality-based standards may offer
additional supplemental benefits, consistent with the requirements of
this part, where CMS finds that the offering of such benefits could
better integrate care for the dual eligible population provided that
the special needs plan--
* * * * *
0
6. Section 422.107 is amended by--
0
a. Revising the section heading;
0
b. In paragraph (a) by removing the term ``dual-eligible'' and adding
in its place the term ``dual eligible'';
0
c. By revising paragraphs (b) and (c)(1), (2), and (3);
0
d. By redesignating paragraph (d) as paragraph (e);
0
e. By adding a new paragraph (d); and
0
f. By adding paragraph (e)(2).
The revisions and additions read as follows:
Sec. 422.107 Special needs plans and dual eligibles: Contract with
State Medicaid Agency.
* * * * *
(b) General rule. MA organizations seeking to offer a dual eligible
special needs plan must have a contract consistent with this section
with the State Medicaid agency.
(c) * * *
(1) The MA organization's responsibility to provide, as applicable,
and coordinate the delivery of Medicaid benefits, including long-term
services and supports and behavioral health services, for individuals
who are eligible for such services.
(2) The category(ies) and criteria for eligibility for dual
eligible individuals to be enrolled under the SNP, including as
described in the Act at sections 1902(a), 1902(f), 1902(p), and 1905.
(3) The Medicaid benefits covered by the MA organization offering
the SNP under a capitated contract with the State Medicaid agency or
covered for the SNP's enrollees under a risk contract as defined in
Sec. 438.2 of this chapter with a Medicaid managed care organization,
as defined in section 1903(m) of the Act, offered by the SNP's parent
organization or another entity that is owned and controlled by its
parent organization.
* * * * *
(d) Additional minimum contract requirement. For any dual eligible
special needs plan that is not a fully integrated or highly integrated
dual eligible special needs plan, the contract must also stipulate
that, for the purpose of coordinating Medicare and Medicaid-covered
services between settings of care, the SNP will notify or authorize
another entity or entities to notify the State Medicaid agency and/or
individuals or entities designated by the State Medicaid agency of
hospital and skilled nursing facility admissions for at least one group
of high-risk full-benefit dual eligible individuals, identified by the
State Medicaid agency. The State Medicaid agency must establish the
timeframe(s) and method(s) by which notice is provided. In the event
that a SNP authorizes another entity or entities to perform this
notification, the SNP must retain responsibility for complying with
this requirement.
(e) * * *
(2) MA organizations offering a dual eligible SNP must comply with
paragraph (d) of this section beginning January 1, 2021.
* * * * *
0
7. Section 422.111 is amended by revising paragraph (b)(2)(iii) to read
as follows:
Sec. 422.111 Disclosure requirements.
* * * * *
(b) * * *
(2) * * *
(iii) By a dual eligible special needs plan, prior to enrollment,
for each prospective enrollee, a comprehensive written statement
describing cost sharing protections and benefits that the individual is
entitled to under title XVIII and the State Medicaid program under
title XIX.
* * * * *
0
8. Section 422.135 is added to subpart C to read as follows:
Sec. 422.135 Additional telehealth benefits.
(a) Definitions. For purposes of this section, the following
definitions apply:
Additional telehealth benefits means services that meet the
following:
(1) Are furnished by an MA plan for which benefits are available
under Medicare Part B but which are not payable under section 1834(m)
of the Act; and
(2) Have been identified by the MA plan for the applicable year as
clinically appropriate to furnish through electronic exchange.
Electronic exchange means electronic information and
telecommunications technology.
(b) General rule. An MA plan may treat additional telehealth
benefits as basic benefits covered under the original Medicare fee-for-
service program for purposes of this part 422 provided that the
requirements of this section are met. If the MA plan fails to comply
with the requirements of this section, then the MA plan may not treat
the benefits provided through electronic exchange as additional
telehealth benefits, but may treat them as supplemental benefits as
described in Sec. 422.102, subject to CMS approval.
(c) Requirements. An MA plan furnishing additional telehealth
benefits must:
(1) Furnish in-person access to the specified Part B service(s) at
the election of the enrollee.
(2) Advise each enrollee, at a minimum in the MA plan's Evidence of
Coverage required at Sec. 422.111(b), that
[[Page 55074]]
the enrollee may receive the specified Part B service(s) through an in-
person visit or through electronic exchange.
(3) Identify, in the MA plan's provider directory required at Sec.
422.111(b)(3)(i), any providers offering services for additional
telehealth benefits and in-person visits or offering services
exclusively for additional telehealth benefits.
(4) Comply with the provider selection and credentialing
requirements provided in Sec. 422.204, and, when providing additional
telehealth benefits, ensure through its contract with the provider that
the provider meet and comply with applicable state licensing
requirements and other applicable laws for the state in which the
enrollee is located and receiving the service.
(5) Make information about coverage of additional telehealth
benefits available to CMS upon request. Information may include, but is
not limited to, statistics on use or cost, manner(s) or method of
electronic exchange, evaluations of effectiveness, and demonstration of
compliance with the requirements of this section.
(d) Requirement to use contracted providers. An MA plan furnishing
additional telehealth benefits may only do so using contracted
providers. Coverage of benefits furnished by a non-contracted provider
through electronic exchange may only be covered as a supplemental
benefit.
(e) Bidding. An MA plan that fully complies with this section may
include additional telehealth benefits in its bid for basic benefits in
accordance with Sec. 422.254.
(f) Cost sharing. MA plans offering additional telehealth benefits
may maintain different cost sharing for the specified Part B service(s)
furnished through an in-person visit and the specified Part B
service(s) furnished through electronic exchange.
Sec. 422.156 [Amended]
0
9. Section 422.156 is amended in paragraph (b)(1) by removing the
phrase ``the quality improvement projects (QIPs) and''.
0
10. Section 422.162 is amended in paragraph (a) by adding the
definitions of ``Absolute percentage cap'', ``Cut point cap'',
``Guardrail'', ``Mean resampling'', ``Restricted range'', and
``Restricted range cap'' in alphabetical order to read as follows:
Sec. 422.162 Medicare Advantage Quality Rating System.
(a) * * *
Absolute percentage cap is a cap applied to non-CAHPS measures that
are on a 0 to 100 scale that restricts movement of the current year's
measure-threshold-specific cut point to no more than the stated
percentage as compared to the prior year's cut point.
* * * * *
Cut point cap is a restriction on the change in the amount of
movement a measure-threshold-specific cut point can make as compared to
the prior year's measure-threshold-specific cut point. A cut point cap
can restrict upward movement, downward movement, or both.
* * * * *
Guardrail is a bidirectional cap that restricts both upward and
downward movement of a measure-threshold-specific cut point for the
current year's measure-level Star Ratings as compared to the prior
year's measure-threshold-specific cut point.
* * * * *
Mean resampling refers to a technique where measure-specific scores
for the current year's Star Ratings are randomly separated into 10
equal-sized groups. The hierarchal clustering algorithm is done 10
times, each time leaving one of the 10 groups out. The method results
in 10 sets of measure-specific cut points. The mean cut point for each
threshold per measure is calculated using the 10 values.
* * * * *
Restricted range is the difference between the maximum and minimum
measure score values using the prior year measure scores excluding
outer fence outliers (first quartile -3*Interquartile Range (IQR) and
third quartile + 3*IQR).
Restricted range cap is a cap applied to non-CAHPS measures that
restricts movement of the current year's measure-threshold-specific cut
point to no more than the stated percentage of the restricted range of
a measure calculated using the prior year's measure score distribution.
* * * * *
0
11. Section 422.164 is amended by adding paragraphs (f)(1)(v),
(g)(1)(iii)(O), and (h) to read as follows:
Sec. 422.164 Adding, updating, and removing measures.
* * * * *
(f) * * *
(1) * * *
(v) CMS will exclude any measure that receives a measure-level Star
Rating reduction for data integrity concerns for either the current or
prior year from the improvement measure(s).
* * * * *
(g) * * *
(1) * * *
(iii) * * *
(O) CMS will reduce a measure rating to 1 star for the applicable
appeals measure(s) if a contract fails to submit Timeliness Monitoring
Project data for CMS's review to ensure the completeness of the
contract's IRE data.
* * * * *
(h) Review of sponsors' data. (1) A request for CMS or the IRE to
review a contract's appeals data must be received no later than June 30
of the following year.
(2) A request for CMS to review a contract's Complaints Tracking
Module (CTM) data must be received no later than June 30 of the
following year.
0
12. Section 422.166 is amended by revising paragraph (a)(2)(i) and
adding paragraph (i) to read as follows:
Sec. 422.166 Calculation of Star Ratings.
(a) * * *
(2) * * *
(i) The method maximizes differences across the star categories and
minimizes the differences within star categories using mean resampling
with the hierarchal clustering of the current year's data, and a
guardrail so that the measure-threshold-specific cut points for non-
CAHPS measures do not increase or decrease more than the value of the
cap from one year to the next. The cap is equal to 5 percentage points
for measures having a 0 to 100 scale (absolute percentage cap) or 5
percent of the restricted range for measures not having a 0 to 100
scale (restricted range cap). New measures that have been in the Part C
and D Star Rating program for three years or less use the hierarchal
clustering methodology with mean resampling with no guardrail for the
first three years in the program.
* * * * *
(i) Extreme and uncontrollable circumstances. In the event of
extreme and uncontrollable circumstances that may negatively impact
operational and clinical systems and contracts' abilities to conduct
surveys needed for accurate performance measurement, CMS will calculate
the Star Ratings as specified in paragraphs (i)(2) through (10) of this
section for each contract that is an affected contract during the
performance period for the applicable measures.
(1) Identification of affected contracts. A contract that meets all
of the following criteria is an affected contract:
(i) The contract's service area is within an ``emergency area''
during an ``emergency period'' as defined in section 1135(g) of the
Act.
(ii) The contract's service area is within a county, parish, U.S.
territory or
[[Page 55075]]
tribal area designated in a major disaster declaration under the
Stafford Act and the Secretary exercised authority under section 1135
of the Act based on the same triggering event(s).
(iii) As specified in paragraphs (i)(2) through (10) of this
section, a certain minimum percentage (25 percent or 60 percent) of the
enrollees under the contract must reside in a Federal Emergency
Management Agency (FEMA)-designated Individual Assistance area at the
time of the extreme and uncontrollable circumstance.
(2) CAHPS adjustments. (i) A contract, even if an affected
contract, must administer the CAHPS survey unless exempt under
paragraph (i)(2)(ii) of this section.
(ii) An affected contract will be exempt from administering the
CAHPS survey if the contract completes both of the following:
(A) Demonstrates to CMS that the required sample for the survey
cannot be contacted because a substantial number of the contract's
enrollees are displaced due to the FEMA-designated disaster identified
in paragraph (i)(1)(iii) of this section in the prior calendar year.
(B) Requests and receives a CMS approved exception.
(iii) An affected contract with an exception defined in paragraph
(i)(2)(ii) of this section will receive the contract's CAHPS measure
stars and corresponding measure scores from the prior year.
(iv) For an affected contract with at least 25 percent of enrollees
in FEMA-designated Individual Assistance areas at the time of the
extreme and uncontrollable circumstance, the contract will receive the
higher of the previous year's Star Rating or the current year's Star
Rating (and corresponding measure score) for each CAHPS measure.
(3) HOS adjustments. (i) An affected contract must administer the
HOS survey unless exempt under paragraph (i)(3)(ii) of this section.
(ii) An affected contract will be exempt from administering the HOS
survey if the contract completes the following:
(A) Demonstrates to CMS that the required sample for the survey
cannot be contacted because a substantial number of the contract's
enrollees are displaced due to the FEMA-designated disaster identified
in (i)(1)(iii) of this section during the measurement period.
(B) Requests and receives a CMS approved exception.
(iii) Affected contracts with an exception defined in paragraph
(i)(3)(ii) of this section will receive the prior year's HOS and
Healthcare Effectiveness Data and Information Set (HEDIS)-HOS measure
stars and corresponding measure scores.
(iv) For an affected contract with at least 25 percent of enrollees
in FEMA-designated Individual Assistance areas at the time of the
extreme and uncontrollable circumstance, the affected contract will
receive the higher of the previous year's Star Rating or the current
year's Star Rating (and corresponding measure score) for each HOS and
HEDIS-HOS measure.
(4) HEDIS adjustments. (i) An affected contract must report HEDIS
data unless exempted under paragraph (i)(4)(ii) of this section.
(ii) An affected contract will be exempt from reporting HEDIS data
if the contract completes the following:
(A) Demonstrates an inability to obtain both administrative and
medical record data that are required for reporting HEDIS measures due
to a FEMA-designated disaster in the prior calendar year.
(B) Requests and receives a CMS approved exception.
(iii) Affected contracts with an exception defined in paragraph
(i)(4)(ii) of this section will receive the prior year's HEDIS measure
stars and corresponding measure scores.
(iv) Affected contracts that do not have an exception defined in
paragraph (i)(4)(ii) of this section may contact National Committee for
Quality Assurance (NCQA) to request modifications to the samples for
measures that require medical record review.
(v) For an affected contract with at least 25 percent of enrollees
in FEMA-designated Individual Assistance areas at the time of the
extreme and uncontrollable circumstance, the affected contract will
receive the higher of the previous year's Star Rating or the current
year's Star Rating (and corresponding measure score) for each HEDIS
measure.
(5) New measure adjustments. For affected contracts with at least
25 percent of enrollees in a FEMA-designated Individual Assistance area
at the time of the extreme and uncontrollable circumstance, CMS will
apply a hold harmless provision by comparing the result of the
contract's summary and/or overall rating with and without including all
of the applicable new measures. If the ``with'' result is lower than
the ``without'' result, then CMS will use the ``without'' result as the
final rating.
(6) Other Star Ratings measure adjustments. (i) For all other
measures except those measures identified in this paragraph (i)(6)(ii)
of this section, affected contracts with at least 25 percent of
enrollees in a FEMA-designated Individual Assistance area at the time
of the extreme and uncontrollable circumstance will receive the higher
of the previous or current year's measure Star Rating and then use the
corresponding measure score.
(ii) CMS will not adjust the scores or Star Ratings for the
following measures, unless the exception in paragraph (i)(6)(iii) of
this section applies.
(A) Part C Call Center--Foreign Language Interpreter and TTY
Availability.
(B) Part D Call Center--Foreign Language Interpreter and TTY
Availability.
(iii) CMS will adjust the measures listed in paragraph (i)(6)(ii)
of this section using the adjustments listed in paragraph (i)(6)(i) of
this section for contracts affected by extreme and uncontrollable
circumstances where there are continuing communications issues related
to loss of electricity and damage to infrastructure during the call
center study.
(7) Exclusion from improvement measures. Any measure that reverts
back to the data underlying the previous year's Star Rating due to the
adjustments made in paragraph (i) of this section will be excluded from
both the count of measures and the applicable improvement measures for
the current and next year's Star Ratings for the affected contract.
(8) Missing data. For an affected contract that has missing data in
the current or previous year, the final measure rating will come from
the current year unless any of the exceptions described in paragraphs
(i)(2)(ii), (i)(3)(ii), and (i)(4)(ii) of this section apply.
(9) Cut points for non-CAHPS measures. (i) CMS will exclude the
numeric values for affected contracts with 60 percent or more of their
enrollees in the FEMA-designated Individual Assistance area at the time
of the extreme and uncontrollable circumstance from the clustering
algorithms described in paragraph (a)(2) of this section.
(ii) The cut points calculated as described in paragraph (i)(9)(i)
of this section will be used to assess all affected contracts' measure
Star Ratings.
(10) Reward Factor. (i) CMS will exclude the numeric values for
affected contracts with 60 percent or more of their enrollees in the
FEMA-designated Individual Assistance area at the time of the extreme
and uncontrollable circumstance from the determination of
[[Page 55076]]
the performance summary and variance thresholds for the Reward Factor
described in paragraph (f)(1) of this section.
(ii) All affected contracts will be eligible for the Reward Factor
based on the calculations described in paragraph (i)(10)(i) of this
section.
0
13. Section 422.222 is amended by revising paragraph (a) to read as
follows:
Sec. 422.222 Preclusion list.
(a)(1)(i) Except as provided in paragraph (a)(1)(ii) of this
section, an MA organization must not make payment for a health care
item or service furnished by an individual or entity that is included
on the preclusion list, defined in Sec. 422.2.
(ii) With respect to MA providers that have been added to an
updated preclusion list, the MA organization must do all of the
following:
(A) No later than 30 days after the posting of this updated
preclusion list, must provide an advance written notice to any
beneficiary who has received an MA service or item from the individual
or entity added to the preclusion list in this update;
(B) Must ensure that reasonable efforts are made to notify the
individual or entity described in paragraph (a)(1)(ii) of this section
of a beneficiary who was sent a notice under paragraph (a)(1)(ii)(A) of
this section; and
(C) Must not deny payment for a service or item furnished by the
newly added individual or entity, solely on the ground that they have
been included in the updated preclusion list, in the 60-day period
after the date it sent the notice described in paragraph (a)(1)(ii)(A)
of this section.
(2)(i) CMS sends written notice to the individual or entity via
letter of their inclusion on the preclusion list. The notice must
contain the reason for the inclusion and inform the individual or
entity of their appeal rights. An individual or entity may appeal their
inclusion on the preclusion list, defined in Sec. 422.2, in accordance
with part 498 of this chapter.
(ii) If the individual's or entity's inclusion on the preclusion
list is based on a contemporaneous Medicare revocation under Sec.
424.535 of this chapter:
(A) The notice described in paragraph (a)(2)(i) of this section
must also include notice of the revocation, the reason(s) for the
revocation, and a description of the individual's or entity's appeal
rights concerning the revocation.
(B) The appeals of the individual's or entity's inclusion on the
preclusion list and the individual's or entity's revocation shall be
filed jointly by the individual or entity and, as applicable,
considered jointly by CMS under part 498 of this chapter.
(3)(i) Except as provided in paragraph (a)(3)(ii) of this section,
an individual or entity will only be included on the preclusion list
after the expiration of either of the following:
(A) If the individual or entity does not file a reconsideration
request under Sec. 498.5(n)(1) of this chapter, the individual or
entity will be added to the preclusion list upon the expiration of the
60-day period in which the individual or entity may request a
reconsideration; or
(B) If the individual or entity files a reconsideration request
under Sec. 498.5(n)(1) of this chapter, the individual or entity will
be added to the preclusion list effective on the date on which CMS, if
applicable, denies the individual's or entity's reconsideration.
(ii) An OIG excluded individual or entity is added to the
preclusion list effective on the date of the exclusion.
(4) Payment denials based upon an individual's or entity's
inclusion on the preclusion list are not appealable by beneficiaries.
(5)(i) Except as provided in paragraphs (a)(5)(iii) and (iv) of
this section, an individual or entity that is revoked under Sec.
424.535 of this chapter will be included on the preclusion list for the
same length of time as the individual's or entity's reenrollment bar.
(ii) Except as provided in paragraphs (a)(5)(iii) and (iv) of this
section, an individual or entity that is not enrolled in Medicare will
be included on the preclusion list for the same length of time as the
reenrollment bar that CMS could have imposed on the individual or
entity had they been enrolled and then revoked.
(iii) Except as provided in paragraph (a)(5)(iv) of this section,
an individual or entity, regardless of whether they are or were
enrolled in Medicare, that is included on the preclusion list because
of a felony conviction will remain on the preclusion list for a 10-year
period, beginning on the date of the felony conviction, unless CMS
determines that a shorter length of time is warranted. Factors that CMS
considers in making such a determination are:
(A) The severity of the offense.
(B) When the offense occurred.
(C) Any other information that CMS deems relevant to its
determination.
(iv) In cases where an individual or entity is excluded by the OIG,
the individual or entity shall remain on the preclusion list until the
expiration of the CMS-imposed preclusion list period or reinstatement
by the OIG, whichever occurs later.
* * * * *
0
14. Section 422.252 is amended by revising the definition of ``MA
monthly basic beneficiary premium'', ``MA monthly MSA premium'',
``Monthly aggregate bid amount'', ``Plan basic cost sharing'', and
``Unadjusted MA statutory non-drug monthly bid amount'' to read as
follows:
Sec. 422.252 Terminology.
* * * * *
MA monthly basic beneficiary premium means the premium amount (if
any) an MA plan (except an MSA plan) charges an enrollee for basic
benefits as defined in Sec. 422.100(c)(1), and is calculated as
described at Sec. 422.262.
MA monthly MSA premium means the amount of the plan premium for
coverage of basic benefits as defined in Sec. 422.100(c)(1) through an
MSA plan, as set forth at Sec. 422.254(e).
* * * * *
Monthly aggregate bid amount means the total monthly plan bid
amount for coverage of an MA eligible beneficiary with a nationally
average risk profile for the factors described in Sec. 422.308(c), and
this amount is comprised of the following:
(1) The unadjusted MA statutory non-drug monthly bid amount for
coverage of basic benefits as defined in Sec. 422.100(c)(1);
(2) The amount for coverage of basic prescription drug benefits
under Part D (if any); and
(3) The amount for provision of supplemental health care benefits
(if any).
* * * * *
Plan basic cost sharing means cost sharing that would be charged by
a plan for basic benefits as defined in Sec. 422.100(c)(1) before any
reductions resulting from mandatory supplemental benefits.
* * * * *
Unadjusted MA statutory non-drug monthly bid amount means a plan's
estimate of its average monthly required revenue to provide coverage of
basic benefits as defined in Sec. 422.100(c)(1) to an MA eligible
beneficiary with a nationally average risk profile for the risk factors
CMS applies to payment calculations as set forth at Sec. 422.308(c).
0
15. Section 422.254 is amended by--
0
a. Revising paragraph (b)(1)(i);
0
b. Adding paragraph (b)(3)(i);
0
c. Reserving paragraph (b)(3)(ii); and
0
d. Revising paragraphs (b)(4), (c)(3)(i), and (e)(2).
The revisions and addition read as follows:
[[Page 55077]]
Sec. 422.254 Submission of bids.
* * * * *
(b) * * *
(1) * * *
(i) The unadjusted MA statutory non-drug monthly bid amount, which
is the MA plan's estimated average monthly required revenue for
providing basic benefits as defined in Sec. 422.100(c)(1).
* * * * *
(3) * * *
(i) MA plans offering additional telehealth benefits as defined in
Sec. 422.135(a) must exclude any capital and infrastructure costs and
investments relating to such benefits from their bid submission.
(ii) [Reserved]
(4) The bid amount is for plan payments only but must be based on
plan assumptions about the amount of revenue required from enrollee
cost-sharing. The estimate of plan cost-sharing for the unadjusted MA
statutory non-drug monthly bid amount for coverage of basic benefits as
defined in Sec. 422.100(c)(1) must reflect the requirement that the
level of cost sharing MA plans charge to enrollees must be actuarially
equivalent to the level of cost sharing (deductible, copayments, or
coinsurance) charged to beneficiaries under the original Medicare fee-
for-service program option. The actuarially equivalent level of cost
sharing reflected in a regional plan's unadjusted MA statutory non-drug
monthly bid amount does not include cost sharing for out-of-network
Medicare benefits, as described at Sec. 422.101(d).
* * * * *
(c) * * *
(3) * * *
(i) The provision of basic benefits as defined in Sec.
422.100(c)(1);
* * * * *
(e) * * *
(2) The amount of the MA monthly MSA premium for basic benefits (as
defined in Sec. 422.252);
* * * * *
0
16. Section 422.264 is amended by revising paragraph (a) to read as
follows:
Sec. 422.264 Calculation of savings.
(a) Computation of risk adjusted bids and benchmarks--(1) The risk
adjusted MA statutory non-drug monthly bid amount is the unadjusted MA
statutory non-drug monthly bid amount (defined at Sec.
422.254(b)(1)(i)), adjusted using the factors described in paragraph
(c) of this section for local plans and paragraph (e) of this section
for regional plans.
(2) The risk adjusted MA area-specific non-drug monthly benchmark
amount is the unadjusted benchmark amount for coverage of basic
benefits defined in Sec. 422.100(c)(1) by a local MA plan, adjusted
using the factors described in paragraph (c) of this section.
(3) The risk adjusted MA region-specific non-drug monthly benchmark
amount is the unadjusted benchmark amount for coverage of basic
benefits defined in Sec. 422.100(c)(1) by a regional MA plan, adjusted
using the factors described in paragraph (e) of this section.
* * * * *
0
17. Section 422.300 is revised to read as follows:
Sec. 422.300 Basis and scope.
This subpart is based on 42 U.S.C. 1106, 1128j(d), 1852, 1853,
1854, and 1858. It sets forth the rules for making payments to MA
organizations offering local and regional MA policies, including
calculation of MA capitation rates and benchmarks, conditions under
which payment is based on plan bids, adjustments to capitation rates
(including risk adjustment), collection of risk adjustment data,
conditions for use and disclosure of risk adjustment data, collection
of improper payments and other payment rules. See Sec. 422.458 for
rules on risk sharing payments to MA regional organizations.
0
18. Section 422.310 is amended by revising paragraph (e) to read as
follows:
Sec. 422.310 Risk adjustment data.
* * * * *
(e) Validation of risk adjustment data. MA organizations and their
providers and practitioners will be required to submit a sample of
medical records for the validation of risk adjustment data, as required
by CMS. There may be penalties for submission of false data. MA
organizations must remit improper payments based on RADV audits and
established in accordance with stated methodology, in a manner
specified by CMS. For RADV audits, CMS may extrapolate RADV Contract-
Level audit findings to Payment Year 2011 forward.
* * * * *
0
19. Section 422.311 is amended by revising paragraph (a) to read as
follows:
Sec. 422.311 RADV audit dispute and appeal processes.
(a) Risk adjustment data validation (RADV) audits. In accordance
with Sec. Sec. 422.2 and 422.310(e), the Secretary annually conducts
RADV audits to ensure risk adjusted payment integrity and accuracy.
Recovery of improper payments from MA organizations will be conducted
according to the Secretary's payment error extrapolation and recovery
methodologies. CMS will apply extrapolation to plan year audits for
payment year 2011 forward.
* * * * *
0
20. Section 422.504 is amended by adding paragraph (g)(1)(iv) to read
as follows:
Sec. 422.504 Contract provisions.
* * * * *
(g) * * *
(1) * * *
(iv) The enrollee shall not have any financial liability for
services or items furnished to the enrollee by an MA contracted
individual or entity on the preclusion list, as defined in Sec. 422.2
and as described in Sec. 422.222.
* * * * *
0
21. Section 422.560 is amended by adding paragraphs (a)(4) and (b)(5)
to read as follows:
Sec. 422.560 Basis and scope.
(a) * * *
(4) Section 1859(f)(8) of the Act provides for, to the extent
feasible, unifying grievances and appeals procedures under sections
1852(f), 1852(g), 1902(a)(3), 1902(a)(5), and 1932(b)(4) of the Act for
Medicare and Medicaid covered items and services provided by
specialized MA plans for special needs individuals described in
subsection 1859(b)(6)(B)(ii) of the Act for individuals who are
eligible under titles XVIII and XIX. Procedures established under
section 1859(f)(8) of the Act apply in place of otherwise applicable
grievances and appeals procedures with respect to Medicare and Medicaid
covered items and services provided by applicable integrated plans.
(b) * * *
(5) Requirements for applicable integrated plans with respect to
procedures for integrated grievances, integrated organization
determinations, and integrated reconsiderations.
* * * * *
0
22. Section 422.561 is amended by adding definitions of ``Applicable
integrated plans'', ``Integrated appeal'', ``Integrated grievance'',
``Integrated organization determination'', and ``Integrated
reconsideration'' in alphabetical order to read as follows:
Sec. 422.561 Definitions.
* * * * *
Applicable integrated plan means:
(1) A fully integrated dual eligible special needs plan with
exclusively aligned enrollment or a highly integrated dual eligible
special needs plan with exclusively aligned enrollment, and
(2) The Medicaid managed care organization, as defined in section
[[Page 55078]]
1903(m) of the Act, through which such dual eligible special needs
plan, its parent organization, or another entity that is owned and
controlled by its parent organization covers Medicaid services for
dually eligible individuals enrolled in such dual eligible special
needs plan and such Medicaid managed care organization.
* * * * *
Integrated appeal means any of the procedures that deal with, or
result from, adverse integrated organization determinations by an
applicable integrated plan on the health care services the enrollee
believes he or she is entitled to receive, including delay in
providing, arranging for, or approving the health care services (such
that a delay would adversely affect the health of the enrollee), or on
any amounts the enrollee must pay for a service. Integrated appeals
cover procedures that would otherwise be defined and covered, for non-
applicable integrated plans, as an appeal defined in Sec. 422.561 or
the procedures required for appeals pursuant to Sec. Sec. 438.400
through 438.424 of this chapter. Such procedures include integrated
reconsiderations.
Integrated grievance means a dispute or compliant that would be
defined and covered, for grievances filed by an enrollee in non-
applicable integrated plans, under Sec. 422.564 or Sec. Sec. 438.400
through 438.416 of this chapter. Integrated grievances do not include
appeals procedures and QIO complaints, as described in Sec. 422.564(b)
and (c). An integrated grievance made by an enrollee in an applicable
integrated plan is subject to the integrated grievance procedures in
Sec. Sec. 422.629 and 422.630.
Integrated organization determination means an organization
determination that would otherwise be defined and covered, for a non-
applicable integrated plan, as organizational determinations under
Sec. 422.566 and an adverse benefit determination under Sec.
438.400(b) and Sec. 431.201 (definition of action) of this chapter. An
integrated organization determination is made by an applicable
integrated plan and is subject to the integrated organization
determination procedures in Sec. Sec. 422.629, 422.631, and 422.634.
Integrated reconsideration means a reconsideration that would
otherwise be defined and covered, for a non-applicable integrated plan,
as a reconsideration under Sec. 422.580 and appeal under Sec.
438.400(b) of this chapter. An integrated reconsideration is made by an
applicable integrated plan and is subject to the integrated
reconsideration procedures in Sec. Sec. 422.629 and 422.632 through
422.634.
* * * * *
0
23. Section 422.562 is amended by--
0
a. Revising paragraph (a)(1)(i);
0
b. By adding paragraph (a)(5); and
0
c. By revising paragraph (b).
The revisions and addition read as follows:
Sec. 422.562 General provisions.
(a) * * *
(1) * * *
(i) A grievance procedure as described in Sec. 422.564 or Sec.
422.630 as applicable, for addressing issues that do not involve
organization determinations;
* * * * *
(5) An MA organization that offers a dual eligible special needs
plan has the following additional responsibilities--
(i) The dual eligible special needs plan must offer to assist an
enrollee in that dual eligible special needs plan with obtaining
Medicaid covered services and resolving grievances, including
requesting authorization of Medicaid services, as applicable, and
navigating Medicaid appeals and grievances in connection with the
enrollee's own Medicaid coverage, regardless of whether such coverage
is in Medicaid fee-for-service or a Medicaid managed care plan, such as
a Medicaid MCO, PIHP, or PAHP as defined in Sec. 438.2 of this
chapter. If the enrollee accepts the offer of assistance, the plan must
provide the assistance. Examples of such assistance include:
(A) Explaining to an enrollee how to make a request for Medicaid
authorization of a service and how to file appeal following an adverse
benefit determination, such as:
(1) Assisting the enrollee in identifying the enrollee's specific
Medicaid managed care plan or fee-for-service point of contact;
(2) Providing specific instructions for contacting the appropriate
agency in a fee-for-service setting or for contacting the enrollee's
Medicaid managed care plan, regardless of whether the Medicaid managed
care plan is affiliated with the enrollee's dual eligible special needs
plan; and
(3) Assisting the enrollee in making contact with the enrollee's
fee-for-service contact or Medicaid managed care plan.
(B) Assisting a beneficiary in filing a Medicaid grievance or a
Medicaid appeal.
(C) Assisting an enrollee in obtaining documentation to support a
request for authorization of Medicaid services or a Medicaid appeal.
(ii) The dual eligible special needs plan must offer to provide the
assistance described in paragraph (a)(5)(i) of this section whenever it
becomes aware of an enrollee's need for a Medicaid-covered service.
Offering such assistance is not dependent on an enrollee's specific
request.
(iii) The dual eligible special needs plan must offer to provide
and actually provide assistance as required by paragraph (a)(5)(i) of
this section using multiple methods.
(A) When an enrollee accepts the offer of assistance described in
paragraph (a)(5)(i) of this section, the dual eligible special needs
plan may coach the enrollee on how to self-advocate.
(B) The dual eligible special needs plan must also provide an
enrollee reasonable assistance in completing forms and taking
procedural steps related to grievances and appeals, including when
assisting with Medicaid appeals.
(iv) The dual eligible special needs plan must, upon request from
CMS, provide documentation demonstrating its compliance with this
paragraph (a)(5).
(v) The obligation to provide assistance under paragraph (a)(5)(i)
of this section does not create an obligation for a dual eligible
special needs plan to represent an enrollee in a Medicaid appeal.
(b) Rights of MA enrollees. In accordance with the provisions of
this subpart, enrollees have the following rights:
(1) The right to have grievances between the enrollee and the MA
organization heard and resolved, as described in Sec. Sec. 422.564 or
422.630, as applicable.
(2) The right to a timely organization determination, as provided
under Sec. Sec. 422.566 or 422.631, as applicable.
(3) The right to request an expedited organization determination,
as provided under Sec. Sec. 422.570 or 422.631(e), as applicable.
(4) If dissatisfied with any part of an organization determination,
the following appeal rights:
(i) The right to a reconsideration of the adverse organization
determination by the MA organization, as provided under Sec. Sec.
422.578 or 422.633, as applicable.
(ii) The right to request an expedited reconsideration, as provided
under Sec. Sec. 422.584 or 422.633(f), as applicable.
(iii) If, as a result of a reconsideration, an MA organization
affirms, in whole or in part, its adverse organization determination,
the right to an automatic reconsidered determination made by an
independent, outside entity contracted by CMS, as provided in Sec.
422.592.
* * * * *
[[Page 55079]]
0
24. Section 422.566 is amended by revising paragraph (a) to read as
follows:
Sec. 422.566 Organization determinations.
(a) Responsibilities of the MA organization. Each MA organization
must have a procedure for making timely organization determinations (in
accordance with the requirements of this subpart) regarding the
benefits an enrollee is entitled to receive under an MA plan, including
basic benefits as described under Sec. 422.100(c)(1) and mandatory and
optional supplemental benefits as described under Sec. 422.102, and
the amount, if any, that the enrollee is required to pay for a health
service. The MA organization must have a standard procedure for making
determinations, in accordance with Sec. 422.568, and an expedited
procedure for situations in which applying the standard procedure could
seriously jeopardize the enrollee's life, health, or ability to regain
maximum function, in accordance with Sec. Sec. 422.570 and 422.572;
for an applicable integrated plan, the MA organization must comply with
Sec. Sec. 422.629 through 422.634 in lieu of Sec. Sec. 422.566(c) and
(d), 422.568, 422.570 and 422.572 with regard to the procedures for
making determinations, including integrated organization determinations
and integrated reconsiderations, on a standard and expedited basis.
* * * * *
0
25. Section 422.629, 422.630, 422.631, 422.632, 422.633, and 422.634
are added to Subpart M under the center heading, ``Requirements
Applicable to Certain Integrated Dual Eligible Special Needs Plans'' to
read as follows:
Subpart M--Grievances, Organization Determinations and Appeals
* * * * *
Requirements Applicable to Certain Integrated Dual Eligible Special
Needs Plans
Sec.
422.629 General requirements for applicable integrated plans.
422.630 Integrated grievances.
422.631 Integrated organization determinations.
422.632 Continuation of benefits while the applicable integrated
plan reconsideration is pending.
422.633 Integrated reconsideration.
422.634 Effect.
Requirements Applicable to Certain Integrated Dual Eligible Special
Needs Plans
Sec. 422.629 General requirements for applicable integrated plans.
(a) Scope. The provisions in this section and in Sec. Sec. 422.630
through 422.634 set forth requirements for unified appeals and
grievance processes with which applicable integrated plans must comply.
(1) These provisions apply to an applicable integrated plan in lieu
of Sec. Sec. 422.564, 422.566(c) and (d), and 422.568 through 422.590
and Sec. Sec. 438.404 through 438.424 of this chapter.
(b) General process. An applicable integrated plan must create
integrated processes for enrollees for integrated grievances and for
integrated organization determinations, and for integrated
reconsiderations.
(c) State flexibilities. A State may, at its discretion, implement
standards for timeframes or notice requirements that are more
protective for the enrollee than required by this section and
Sec. Sec. 422.630 through 422.634. The contract under Sec. 422.107
must include any standards that differ from the standards set forth in
this section.
(d) Evidence. The applicable integrated plan must provide the
enrollee a reasonable opportunity, in person and in writing, to present
evidence and testimony and make legal and factual arguments for
integrated grievances, integrated reconsiderations. The applicable
integrated plan must inform the enrollee of the limited time available
for presenting evidence sufficiently in advance of the resolution
timeframe for appeals as specified in this section if the case is being
considered under an expedited timeframe for the integrated grievance or
integrated reconsideration.
(e) Assistance. In addition to the requirements in Sec.
422.562(a)(5), the applicable integrated plan must provide an enrollee
reasonable assistance in completing forms and taking other procedural
steps related to integrated grievances and integrated appeals.
(f) Applicable requirements. The requirements in Sec. Sec.
422.560, 422.561, 422.562, 422.566, and 422.592 through 422.626 apply
to an applicable integrated plan unless otherwise provided in this
section or in Sec. Sec. 422.630 through 422.634.
(g) Acknowledgement. The applicable integrated plan must send to
the enrollee written acknowledgement of integrated grievances and
integrated reconsiderations upon receiving the request.
(h) Recordkeeping. (1) The applicable integrated plan must maintain
records of integrated grievances and integrated appeals. Each
applicable integrated plan that is a Medicaid managed care organization
must review the Medicaid-related information as part of its ongoing
monitoring procedures, as well as for updates and revisions to the
State quality strategy.
(2) The record of each integrated grievance or integrated appeal
must contain, at a minimum:
(i) A general description of the reason for the integrated appeal
or integrated grievance.
(ii) The date of receipt.
(iii) The date of each review or, if applicable, review meeting.
(iv) Resolution at each level of the integrated appeal or
integrated grievance, if applicable.
(v) Date of resolution at each level, if applicable.
(vi) Name of the enrollee for whom the integrated appeal or
integrated grievance was filed.
(vii) Date the applicable integrated plan notified the enrollee of
the resolution.
(3) The record of each integrated grievance or integrated appeal
must be accurately maintained in a manner accessible to the State and
available upon request to CMS.
(i) Prohibition on punitive action. Each applicable integrated plan
must ensure that no punitive action is taken against a provider that
requests an integrated organization determination or integrated
reconsideration, or supports an enrollee's request for these actions.
(j) Information to providers and subcontractors. The applicable
integrated plan must provide information about the integrated grievance
and integrated appeal system to all providers and subcontractors at the
time they enter into a contract including, at minimum, information on
integrated grievance, integrated reconsideration, and fair hearing
procedures and timeframes as applicable. Such information must include:
(1) The right to file an integrated grievance and integrated
reconsideration.
(2) The requirements and timeframes for filing an integrated
grievance or integrated reconsideration.
(3) The availability of assistance in the filing process.
(k) Review decision-making requirement--(1) General rules.
Individuals making decisions on integrated appeals and grievances must
take into account all comments, documents, records, and other
[[Page 55080]]
information submitted by the enrollee or their representative without
regard to whether such information was submitted or considered in the
initial adverse integrated organization determination.
(2) Integrated grievances. Individuals making decisions on
integrated grievances must be individuals who:
(i) Were neither involved in any previous level of review or
decision-making nor a subordinate of any such individual.
(ii) If deciding any of the following, have the appropriate
clinical expertise in treating the enrollee's condition or disease:
(A) A grievance regarding denial of expedited resolution of an
appeal.
(B) A grievance that involves clinical issues.
(3) Integrated organization determinations. If the applicable
integrated plan expects to issue a partially or fully adverse medical
necessity (or any substantively equivalent term used to describe the
concept of medical necessity) decision based on the initial review of
the request, the integrated organization determination must be reviewed
by a physician or other appropriate health care professional with
sufficient medical and other expertise, including knowledge of Medicare
and Medicaid coverage criteria, before the applicable integrated plan
issues the integrated organization determination. Any physician or
other health care professional who reviews an integrated organization
determination must have a current and unrestricted license to practice
within the scope of his or her profession.
(4) Integrated reconsideration determinations. Individuals making
an integrated reconsideration determination must be individuals who:
(i) Were neither involved in any previous level of review or
decision-making nor a subordinate of any such individual.
(ii) If deciding an appeal of a denial that is based on lack of
medical necessity (or any substantively equivalent term used to
describe the concept of medical necessity), are a physician or other
appropriate health care professional who have the appropriate clinical
expertise, in treating the enrollee's condition or disease, and
knowledge of Medicare coverage criteria, before the MA organization
issues the organization determination decision.
(l) Parties. (1) The individuals or entity who can request an
integrated grievance and integrated organization determination and
integrated reconsideration are:
(i) The enrollee or his or her representative;
(ii) An assignee of the enrollee (that is, a physician or other
provider who has furnished or intends to furnish a service to the
enrollee and formally agrees to waive any right to payment from the
enrollee for that service), or any other provider or entity (other than
the applicable integrated plan) who has an appealable interest in the
proceeding. If the provider is requesting an integrated reconsideration
on behalf of an enrollee, the provider must provide notice to the
enrollee. If the provider or authorized representative requests that
the benefits continue while the appeal is pending, pursuant to Sec.
422.632 and consistent with state law, the provider or authorized
representative must obtain the written consent of the enrollee to
request the appeal on behalf of the enrollee; or
(iii) The legal representative of a deceased enrollee's estate.
(2) When the term ``enrollee'' is used throughout this section, it
includes providers that file a request and authorized representatives
consistent with this paragraph, unless otherwise specified.
(3) The parties who can request an expedited integrated
organization determination are--
(i) The enrollee (including his or her representative); or
(ii) A provider.
Sec. 422.630 Integrated grievances.
(a) General rule. In lieu of complying with Sec. 422.564, and the
grievance requirements of Sec. Sec. 438.402, 438.406, 438.408,
438.414, and 438.416 of this chapter, each applicable integrated plan
must comply with this section. Each applicable integrated plan must
provide meaningful procedures for timely hearing and resolving
integrated grievances between enrollees and the applicable integrated
plan or any other entity or individual through which the applicable
integrated plan provides health care services.
(b) Timing. An enrollee may file an integrated grievance at any
time with the applicable integrated plan.
(c) Filing. An enrollee may file an integrated grievance orally or
in writing with the applicable integrated plan, or with the State for
an integrated grievance related to a Medicaid benefit, if the State has
a process for accepting Medicaid grievances.
(d) Expedited grievances. An applicable integrated plan must
respond to an enrollee's grievance within 24 hours if:
(1) The complaint involves the applicable integrated plan's
decision to invoke an extension relating to an integrated organization
determination or integrated reconsideration.
(2) The complaint involves the applicable integrated plan's refusal
to grant an enrollee's request for an expedited organization
determination under Sec. 422.631 or integrated reconsideration under
Sec. 422.633.
(e) Resolution and notice. (1) The applicable integrated plan must
resolve standard integrated grievances as expeditiously as the case
requires, based on the enrollee's health status, but no later than 30
calendar days from the date it receives the integrated grievance.
(i) All integrated grievances submitted in writing must be
responded to in writing.
(ii) Integrated grievances submitted orally may be responded to
either orally or in writing, unless the enrollee requests a written
response.
(iii) All integrated grievances related to quality of care,
regardless of how the integrated grievance is filed, must be responded
to in writing. The response must include a description of the
enrollee's right to file a written complaint with the QIO with regard
to Medicare covered services. For any complaint submitted to a QIO, the
applicable integrated plan must cooperate with the QIO in resolving the
complaint.
(2) The timeframe for resolving the integrated grievance may be
extended by 14 calendar days if the enrollee requests an extension or
if the applicable integrated plan justifies the need for additional
information and documents how the delay is in the interest of the
enrollee. When the applicable integrated plan extends the timeframe, it
must:
(i) Make reasonable efforts to promptly notify the enrollee orally
of the reasons for the delay, and
(ii) Send written notice to the enrollee of the reasons for the
delay immediately, but no later than within 2 calendar days. This
notice must explain the right to file an integrated grievance if the
enrollee disagrees with the decision to delay.
Sec. 422.631 Integrated organization determinations.
(a) General rule. An applicable integrated plan must adopt and
implement a process for enrollees to request that the plan make an
integrated organization determination. The process for requesting that
the applicable integrated plan make an integrated organization
determination must be the same for all covered benefits.
[[Page 55081]]
(b) Requests. The enrollee, or a provider on behalf of an enrollee,
may request an integrated organization determination orally or in
writing, except for requests for payment, which must be in writing
(unless the applicable integrated plan or entity responsible for making
the determination has implemented a voluntary policy of accepting
verbal payment requests).
(c) Expedited integrated organization determinations. (1) An
enrollee, or a provider on behalf of an enrollee, may request an
expedited integrated organization determination.
(2) The request can be oral or in writing.
(3) The applicable integrated plan must complete an expedited
integrated organization determination when the applicable integrated
plan determines (based on a request from the enrollee or on its own) 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.
(d) Timeframes and notice--(1) Integrated organization
determination notice. The applicable integrated plan must send an
enrollee a written notice of any adverse decision on an integrated
organization determination (including a determination to authorize a
service or item in an amount, duration, or scope that is less than the
amount previously requested or authorized for an ongoing course of
treatment) within the timeframes set forth in this section. For an
integrated organization determination not reached within the timeframes
specified in this section (which constitutes a denial and is thus an
adverse decision), the applicable integrated plan must send a notice on
the date that the timeframes expire. Such notice must describe all
applicable Medicare and Medicaid appeal rights. Integrated organization
determination notices must be written in plain language, be available
in a language and format that is accessible to the enrollee, and
explain:
(i) The applicable integrated plan's determination;
(ii) The date the determination was made;
(iii) The date the determination will take effect;
(iv) The reasons for the determination;
(v) The enrollee's right to file an integrated reconsideration and
the ability for someone else to file an appeal on the enrollee's
behalf;
(vi) Procedures for exercising enrollee's rights to an integrated
reconsideration;
(vii) Circumstances under which expedited resolution is available
and how to request it; and
(viii) If applicable, the enrollee's rights to have benefits
continue pending the resolution of the integrated appeal process.
(2) Timing of notice--(i) Standard integrated organization
determinations. (A) The applicable integrated plan must send a notice
of its integrated organization determination at least 10 days before
the date of action (that is, before the date on which a termination,
suspension, or reduction becomes effective), in cases where a
previously approved service is being reduced, suspended, or terminated,
except in circumstances where an exception is permitted under
Sec. Sec. 431.213 and 431.214 of this chapter.
(B) For other integrated organization determinations that are not
expedited integrated organization determinations, the applicable
integrated plan must send a notice of its integrated organization
determination as expeditiously as the enrollee's health condition
requires, but no later than 14 calendar days from when it receives the
request for the integrated organization determination.
(ii) Extensions. The applicable integrated plan may extend the
timeframe for a standard or expedited integrated organization
determination by up to 14 calendar days if:
(A) The enrollee or provider requests the extension; or
(B) The applicable integrated plan can show that:
(1) The extension is in the enrollee's interest; and
(2) There is need for additional information and there is a
reasonable likelihood that receipt of such information would lead to
approval of the request, if received.
(iii) Notices in cases of extension. (A) When the applicable
integrated plan extends the timeframe, it must notify the enrollee in
writing of the reasons for the delay as expeditiously as the enrollee's
health condition requires but no later than upon expiration of the
extension, and inform the enrollee of the right to file an expedited
integrated grievance if he or she disagrees with the applicable
integrated plan's decision to grant an extension.
(B) If the applicable integrated plan extends the timeframe for
making its integrated organization determination, it must send the
notice of its determination as expeditiously as the enrollee's health
condition requires and no later than the date the extension expires.
(iv) Expedited integrated organization determinations. (A) The
applicable integrated plan must provide notice of its expedited
integrated organization determination as expeditiously as the
enrollee's health condition requires, but no later than 72 hours after
receiving the request.
(B) If the applicable integrated plan denies the request for an
expedited integrated organization determination, it must:
(1) Automatically transfer a request to the standard timeframe and
make the determination within the 14-day timeframe established in this
paragraph for a standard integrated organization determination. The 14-
day period begins with the day the applicable integrated plan receives
the request for expedited integrated organization determination.
(2) Give the enrollee prompt oral notice of the denial and transfer
and subsequently deliver, within 3 calendar days, a written letter
that--
(i) Explains that the applicable integrated plan will process the
request using the 14-day timeframe for standard integrated organization
determinations;
(ii) Informs the enrollee of the right to file an expedited
integrated grievance if he or she disagrees with the applicable
integrated plan's decision not to expedite;
(iii) Informs the enrollee of the right to resubmit a request for
an expedited integrated organization determination with any physician's
support; and
(iv) Provides instructions about the integrated grievance process
and its timeframes.
(C) If the applicable integrated plan must receive medical
information from noncontract providers, the applicable integrated plan
must request the necessary information from the noncontract provider
within 24 hours of the initial request for an expedited integrated
organization determination. Noncontract providers must make reasonable
and diligent efforts to expeditiously gather and forward all necessary
information to assist the applicable integrated plan in meeting the
required timeframe. Regardless of whether the applicable integrated
plan must request information from noncontract providers, the
applicable integrated plan is responsible for meeting the timeframe and
notice requirements of this section.
[[Page 55082]]
Sec. 422.632 Continuation of benefits while the applicable
integrated plan reconsideration is pending.
(a) Definition. As used in this section, timely files means files
for continuation of benefits on or before the later of the following:
(1) Within 10 calendar days of the applicable integrated plan
sending the notice of adverse integrated organization determination.
(2) The intended effective date of the applicable integrated plan's
proposed adverse integrated organization determination.
(b) Continuation of benefits. The applicable integrated plan must
continue the enrollee's benefits under Parts A and B of title XVIII and
title XIX if all of the following occur:
(1) The enrollee files the request for an integrated appeal timely
in accordance with Sec. 422.633(e);
(2) The integrated 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 applicable integrated plan continues or
reinstates the enrollee's benefits, as described in paragraph (b) of
this section, while the integrated reconsideration is pending, the
benefits must be continued until:
(1) The enrollee withdraws the request for an integrated
reconsideration;
(2) The applicable integrated plan issues an integrated
reconsideration that is unfavorable to the enrollee related to the
benefit that has been continued;
(3) For an appeal involving Medicaid benefits:
(i) The enrollee fails to file a request for a State fair hearing
and continuation of benefits, within 10 calendar days after the
applicable integrated plan sends the notice of the integrated
reconsideration;
(ii) The enrollee withdraws the appeal or request for a State fair
hearing;
(iii) A State fair hearing office issues a hearing decision adverse
to the enrollee.
(d) Recovery of costs. In the event the appeal or State fair
hearing is adverse to the enrollee, the applicable integrated plan or
State agency may not pursue recovery for services provided, to the
extent that the services were furnished solely under of the
requirements of this section.
Sec. 422.633 Integrated reconsideration.
(a) General rule. An applicable integrated plan may only have one
level of integrated reconsideration for an enrollee.
(b) External medical reviews. If a State has established an
external medical review process, the requirements of Sec.
438.402(c)(1)(i)(B) of this chapter apply to each applicable integrated
plan that is a Medicaid managed care organization, as defined in
section 1903 of the Act.
(c) Case file. Upon request of the enrollee or his or her
representative, the applicable integrated plan must 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
applicable integrated plan (or at the direction of the applicable
integrated plan) in connection with the appeal of the integrated
organization determination. This information must be provided free of
charge and sufficiently in advance of the resolution timeframe for
appeals as specified in this section.
(d) Timing. (1) An enrollee has 60 calendar days from the date on
the adverse organization determination notice to file a request for an
integrated reconsideration with the applicable integrated plan.
(2) Oral inquires seeking to appeal an adverse integrated
organization determination must be treated as a request for an
integrated reconsideration (to establish the earliest possible filing
date for the appeal).
(3) Extending the time for filing a request--(i) General rule. If a
party or physician acting on behalf of an enrollee shows good cause,
the applicable integrated plan may extend the timeframe for filing a
request for an integrated reconsideration.
(ii) How to request an extension of timeframe. If the 60-day period
in which to file a request for an integrated reconsideration has
expired, a party to the integrated organization determination or a
physician acting on behalf of an enrollee may file a request for
integrated reconsideration with the applicable integrated plan. The
request for integrated reconsideration and to extend the timeframe
must--
(A) Be in writing; and
(B) State why the request for integrated reconsideration was not
filed on time.
(e) Expedited integrated reconsiderations. (1) An enrollee may
request, or a provider may request on behalf of an enrollee, an
expedited review of the integrated reconsideration.
(2) The request can be oral or in writing.
(3) The applicable integrated plan must grant the request to
expedite the integrated reconsideration when it 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.
(4) If an applicable integrated plan denies an enrollee's request
for an expedited integrated reconsideration, it must automatically
transfer a request to the standard timeframe and make the determination
within the 30-day timeframe established in paragraph (f)(1) of this
section for a standard integrated reconsideration. The 30-day period
begins with the day the applicable integrated plan receives the request
for expedited integrated reconsideration. The applicable integrated
plan must give the enrollee prompt oral notice of the decision, and
give the enrollee written notice within 2 calendar days. The written
notice must:
(i) Include the reason for the denial;
(ii) Inform the enrollee of the right to file a grievance if the
enrollee disagrees with the decision not to expedite, including
timeframes and procedures for filing a grievance; and
(iii) Inform the enrollee of the right to resubmit a request for an
expedited determination with any physician's support.
(5) If the applicable integrated plan must receive medical
information from noncontract providers, the applicable integrated plan
must request the necessary information from the noncontract provider
within 24 hours of the initial request for an expedited integrated
reconsideration. Noncontract providers must make reasonable and
diligent efforts to expeditiously gather and forward all necessary
information to assist the applicable integrated plan in meeting the
required timeframe. Regardless of whether the applicable integrated
plan must request information from noncontract providers, the
applicable integrated plan is responsible for meeting the timeframe and
notice requirements of this section.
(f) Resolution and notification. The applicable integrated plan
must make integrated reconsidered determinations as expeditiously as
the enrollee's health condition requires but no later than the
timeframes established in this section.
(1) Standard integrated reconsiderations. The applicable
[[Page 55083]]
integrated plan must resolve integrated reconsiderations within 30
calendar days of receipt of the request or as expeditiously as the
enrollee's health condition requires for the integrated
reconsideration. This timeframe may be extended as described in
paragraph (f)(3) of this section.
(2) Expedited integrated reconsiderations. The applicable
integrated plan must resolve expedited integrated reconsiderations
within 72 hours of receipt of the request or as expeditiously as the
enrollee's health condition requires for the integrated
reconsideration. This timeframe may be extended as described in
paragraph (f)(3) of this section. The applicable integrated plan must
make reasonable efforts to provide prompt oral notice of the expedited
resolution to the enrollee.
(3) Extensions. (i) The applicable integrated plan may extend the
timeframe for resolving integrated reconsiderations by 14 calendar days
if:
(A) The enrollee requests the extension; or
(B) The applicable integrated plan can show that:
(1) The extension is in the enrollee's interest; and
(2) There is need for additional information and there is a
reasonable likelihood that receipt of such information would lead to
approval of the request, if received.
(ii) If the applicable integrated plan extends the timeframe for
resolving the integrated reconsideration, it must make reasonable
efforts to give the enrollee prompt oral notice of the delay, and give
the enrollee written notice within 2 calendar days. The notice must
include the reason for the delay, and inform the enrollee of the right
to file an expedited grievance if he or she disagrees with the decision
to grant an extension.
(4) Notice of resolution. The applicable integrated plan must send
a notice to enrollees that includes the integrated reconsidered
determination, within the resolution timeframes set forth in this
section. The notice of determination must be written in plain language
and available in a language and format that is accessible to the
enrollee, and must explain:
(i) The resolution of and basis for the integrated reconsideration
and the date it was completed.
(ii) For integrated reconsiderations not resolved wholly in favor
of the enrollee:
(A) An explanation of the next level of appeal available under the
Medicare and Medicaid programs, and what steps the enrollee must take
to pursue the next level of appeal under each program; and
(B) The right to request and receive Medicaid-covered benefits
while the next level of appeal is pending, if applicable.
Sec. 422.634 Effect.
(a) Failure of the applicable integrated plan to send timely notice
of a determination. If the applicable integrated plan fails to adhere
to the notice and timing for an integrated organization determination
or integrated reconsideration, this failure constitutes an adverse
determination for the enrollee. For an integrated organization
determination, this means that the enrollee may request an integrated
reconsideration (to the next applicable level in the appeal process).
For integrated reconsiderations of Medicare benefits, this means the
applicable integrated plan must forward the case to the independent
review entity, in accordance with the timeframes under paragraph (b) of
this section and Sec. 422.592. For integrated reconsiderations of
Medicaid benefits, this means that an enrollee or other party may file
for a State fair hearing, or if applicable, a State external medical
review in accordance with Sec. 438.402(c) of this chapter.
(b) Adverse integrated reconsiderations. (1) Subject to paragraph
(b)(2) of this section, when the applicable integrated plan affirms, in
whole or in part, its adverse integrated organization determination
involving a Medicare benefit:
(i) The issues that remain in dispute must be reviewed and resolved
by an independent, outside entity that contracts with CMS, in
accordance with Sec. 422.592 and Sec. Sec. 422.594 through 422.619;
and
(ii) For standard integrated reconsiderations, the applicable
integrated plan must prepare a written explanation and send the case
file to the independent review entity contracted by CMS, as
expeditiously as the enrollee's health condition requires, but no later
than 30 calendar days from the date it receives the request (or no
later than the expiration of an extension described in Sec.
422.633(f)(3)). The applicable integrated plan must make reasonable and
diligent efforts to assist in gathering and forwarding information to
the independent entity.
(iii) For expedited integrated reconsiderations, the applicable
integrated plan must prepare a written explanation and send the case
file to the independent review entity contracted by CMS as
expeditiously as the enrollee's health condition requires, but no later
than within 24 hours of its affirmation (or no later than the
expiration of an extension described in Sec. 422.633(f)(3)). The
applicable integrated plan must make reasonable and diligent efforts to
assist in gathering and forwarding information to the independent
entity.
(2) When the applicable integrated plan affirms, in whole or in
part, its adverse integrated organization determination involving a
Medicaid benefit, the enrollee or other party (that is not the
applicable integrated plan) may initiate a State fair hearing no later
than 120 calendar days from the date of the applicable integrated
plan's notice of resolution. If a provider is filing for a State fair
hearing on behalf of the enrollee as permitted by State law, the
provider will need the written consent of the enrollee, if he or she
has not already obtained such consent.
(c) Final determination. The reconsidered determination of the
applicable integrated plan is binding on all parties unless it is
appealed to the next applicable level. In the event that the enrollee
pursues the appeal in multiple forums and receives conflicting
decisions, the applicable integrated plan is bound by, and must act in
accordance with, decisions favorable to the enrollee.
(d) Services not furnished while the appeal is pending. If an
applicable integrated plan, or a State fair hearing with regard to a
Medicaid benefit, reverses a decision to deny, limit, or delay services
that were not furnished while the appeal was pending, the applicable
integrated plan 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. Reversals by the Part C independent review
entity, an administrative law judge or attorney adjudicator at the
Office of Medicare Hearings and Appeals, or the Medicare Appeals
Council must be effectuated under same timelines applicable to other MA
plans as specified in Sec. Sec. 422.618 and 422.619.
(e) Services furnished while the appeal is pending. If the
applicable integrated plan or the State fair hearing officer reverses a
decision to deny, limit, or delay Medicaid-covered benefits, and the
enrollee received the disputed services while the integrated
reconsideration was pending, the applicable integrated plan or the
State must pay for those services, in accordance with State policy and
regulations. If the applicable integrated plan reverses a decision to
deny, limit, or delay Medicare-covered benefits, and the enrollee
received the disputed services while the integrated reconsideration was
pending, the
[[Page 55084]]
applicable integrated plan must pay for those services.
0
26. Section 422.752 is amended by adding paragraph (d) to read as
follows:
Sec. 422.752 Basis for imposing intermediate sanctions and civil
money penalties.
* * * * *
(d) Special rule for non-compliant dual eligible special needs
plans. Notwithstanding any other provision of this section, CMS must
impose during plan years 2021 through 2025 intermediate sanctions
specified at Sec. 422.750(a) on an MA organization with a contract to
operate a dual eligible special needs plan if CMS determines that the
dual eligible special needs plan fails to comply with at least one of
the criteria for the integration of Medicare and Medicaid benefits
provided in the definition of a dual eligible special needs plan at
Sec. 422.2. If CMS imposes such an intermediate sanction, the MA
organization must submit to CMS a corrective action plan in a form,
manner, and timeframe established by CMS. The procedures outlined in
Sec. 422.756 apply to the imposition of the intermediate sanction
under this provision.
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
0
27. The authority citation for part 423 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, and
1395hh.
0
28. Section 423.100 is amended in the definition of ``Preclusion list''
by revising paragraphs (1)(i), (2)(i), (2)(ii)(C) and adding paragraph
(3) to read as follows:
Sec. 423.100 Definitions.
* * * * *
Preclusion list * * *
(1) * * *
(i) The prescriber is currently revoked from Medicare for a reason
other than that stated in Sec. 424.535(a)(3) of this chapter.
* * * * *
(2) * * *
(i) The prescriber has engaged in behavior, other than that
described in Sec. 424.535(a)(3) of this chapter, for which CMS could
have revoked the prescriber to the extent applicable had the prescriber
been enrolled in Medicare.
* * * * *
(ii) * * *
(C) Any other evidence that CMS deems relevant to its
determination; or
(3) The prescriber, regardless of whether the prescriber is or was
enrolled in Medicare, has been convicted of a felony under federal or
state law within the previous 10 years that CMS deems detrimental to
the best interests of the Medicare program. Factors that CMS considers
in making such a determination under this paragraph are:
(i) The severity of the offense;
(ii) When the offense occurred; and
(iii) Any other information that CMS deems relevant to its
determination.
* * * * *
0
29. Section 423.120 is amended by--
0
a. Revising paragraphs (c)(6)(i) through (v) and (c)(6)(vi)
introductory text; and
0
b. Adding paragraphs (c)(6)(vii) and (viii).
The revisions and additions read as follows:
Sec. 423.120 Access to covered Part D drugs.
* * * * *
(c) * * *
(6)(i) Except as provided in paragraph (c)(6)(iv) of this section,
a Part D sponsor must reject, or must require its PBM to reject, a
pharmacy claim for a Part D drug if the prescriber who prescribed the
drug is included on the preclusion list, defined in Sec. 423.100.
(ii) Except as provided in paragraph (c)(6)(iv) of this section, a
Part D sponsor must deny, or must require its PBM to deny, a request
for reimbursement from a Medicare beneficiary if the request pertains
to a Part D drug that was prescribed by a prescriber who is identified
by name in the request and who is included on the preclusion list,
defined in Sec. 423.100.
(iii) A Part D plan sponsor may not submit a prescription drug
event (PDE) record to CMS unless it includes on the PDE record the
active and valid NPI of the prescriber of the drug, and the prescriber
is not included on the preclusion list, defined in Sec. 423.100, for
the date of service.
(iv) With respect to Part D prescribers that have been added to an
updated preclusion list, the Part D plan sponsor must do all of the
following:
(A) Subject to all other Part D rules and plan coverage
requirements, and no later than 30 days after the posting of this
updated preclusion list, must provide an advance written notice to any
beneficiary who has received a Part D drug prescribed by a prescriber
added to the preclusion list in this update;
(B) Must ensure that reasonable efforts are made to notify the
prescriber described in paragraph (c)(6)(iv) of this section of a
beneficiary who was sent a notice under paragraph (c)(6)(iv)(A) of this
section; and
(C) Must not reject a pharmacy claim or deny a beneficiary request
for reimbursement for a Part D drug prescribed by the prescriber,
solely on the ground that they have been included in the updated
preclusion list, in the 60-day period after the date it sent the notice
described in paragraph (c)(6)(iv)(A) of this section.
(v)(A) CMS sends written notice to the prescriber via letter of
their inclusion on the preclusion list. The notice must contain the
reason for the inclusion on the preclusion list and inform the
prescriber of their appeal rights. A prescriber may appeal their
inclusion on the preclusion list under this section in accordance with
part 498 of this chapter.
(B) If the prescriber's inclusion on the preclusion list is based
on a contemporaneous Medicare revocation under Sec. 424.535 of this
chapter:
(1) The notice described in paragraph (c)(6)(v)(A) of this section
must also include notice of the revocation, the reason(s) for the
revocation, and a description of the prescriber's appeal rights
concerning the revocation.
(2) The appeals of the prescriber's inclusion on the preclusion
list and the prescriber's revocation shall be filed jointly by the
prescriber and, as applicable, considered jointly by CMS under part 498
of this chapter.
(C)(1) Except as provided in paragraph (c)(6)(v)(C)(2) of this
section, a prescriber will only be included on the preclusion list
after the expiration of either of the following:
(i) If the prescriber does not file a reconsideration request under
Sec. 498.5(n)(1) of this chapter, the prescriber will be added to the
preclusion list upon the expiration of the 60-day period in which the
prescriber may request a reconsideration.
(ii) If the prescriber files a reconsideration request under Sec.
498.5(n)(1) of this chapter, the prescriber will be added to the
preclusion list effective on the date on which CMS, if applicable,
denies the prescriber's reconsideration.
(2) An OIG excluded prescriber is added to the preclusion list
effective on the date of the exclusion.
(vi) CMS has the discretion not to include a particular prescriber
on (or, if warranted, remove the prescriber from) the preclusion list
should it determine that exceptional circumstances exist regarding
beneficiary access to prescriptions. In making a determination as to
whether such circumstances exist, CMS takes into account--
* * * * *
(vii)(A) Except as provided in paragraphs (c)(6)(vii)(C) and (D) of
this
[[Page 55085]]
section, a prescriber who is revoked under Sec. 424.535 of this
chapter will be included on the preclusion list for the same length of
time as the prescriber's reenrollment bar.
(B) Except as provided in paragraphs (c)(6)(vii)(C) and (D) of this
section, a prescriber who is not enrolled in Medicare will be included
on the preclusion list for the same length of time as the reenrollment
bar that CMS could have imposed on the prescriber had the prescriber
been enrolled and then revoked.
(C) Except as provided in paragraph (c)(6)(vii)(D) of this section,
a prescriber, regardless of whether the prescriber is or was enrolled
in Medicare, that is included on the preclusion list because of a
felony conviction will remain on the preclusion list for a 10-year
period, beginning on the date of the felony conviction, unless CMS
determines that a shorter length of time is warranted. Factors that CMS
considers in making such a determination are--
(1) The severity of the offense;
(2) When the offense occurred; and
(3) Any other information that CMS deems relevant to its
determination.
(D) In cases where a prescriber is excluded by the OIG, the
prescriber must remain on the preclusion list until the expiration of
the CMS-imposed preclusion list period or reinstatement by the OIG,
whichever occurs later.
(viii) Payment denials under paragraph (c)(6) of this section that
are based upon the prescriber's inclusion on the preclusion list are
not appealable by beneficiaries.
* * * * *
0
30. Section 423.153 is amended by revising the section heading and
adding paragraph (g) to read as follows:
Sec. 423.153 Prescription drug plan sponsors' access to Medicare
Parts A and B claims data extracts.
* * * * *
(g) Parts A and B claims data extracts--(1) General rule. (i)
Beginning in plan year 2020, a PDP sponsor may submit a request to CMS
for the data described in paragraph (g)(2) of this section about
enrollees in its prescription drug plans.
(ii) CMS will make the data requested in paragraph (g)(1)(i) of
this section available to eligible PDP sponsors, in accordance with all
applicable laws. The data will be provided at least quarterly on a
specified release date, and in an electronic format to be determined by
CMS.
(iii) If CMS determines or has a reasonable belief that the PDP
sponsor has violated the requirements of this paragraph (g) or that
unauthorized uses, reuses, or disclosures of the Medicare claims data
have taken place, at CMS' sole discretion, the PDP sponsor may be
denied further access to the data described in paragraph (g)(2) of this
section.
(2) Data described. The data that may be requested under paragraph
(g)(1) of this section are standardized extracts of claims data under
Medicare parts A and B for items and services furnished under such
parts to beneficiaries who are enrolled in a plan offered by the PDP
sponsor at the time of the disclosure.
(3) Purposes. A PDP sponsor must comply with all laws that may be
applicable to data received under this provision, including state and
federal privacy and security laws, and, furthermore subject to the
limitations in paragraph (g)(4) of this section may only use or
disclose the data provided by CMS under paragraph (g)(1) of this
section for the following purposes:
(i) To optimize therapeutic outcomes through improved medication
use, as such phrase is used in paragraph (d)(1)(i) of this section.
(ii) To improve care coordination so as to prevent adverse health
outcomes, such as preventable emergency department visits and hospital
readmissions.
(iii) For activities falling under paragraph (1) of the definition
of ``health care operations'' under 45 CFR 164.501.
(iv) For activities falling under paragraph (2) of the definition
of ``health care operations'' under 45 CFR 164.501.
(v) For ``fraud and abuse detection or compliance activities''
under 45 CFR 164.506(c)(4)(ii).
(vi) For disclosures that qualify as ``required by law''
disclosures at 45 CFR 164.103.
(4) Limitations. A PDP sponsor must comply with the following
requirements regarding the data provided by CMS under this paragraph
(g):
(i) The PDP sponsor will not use the data to inform coverage
determinations under Part D;
(ii) The PDP sponsor will not use the data to conduct retroactive
reviews of medically accepted indications determinations;
(iii) The PDP sponsor will not use the data to facilitate
enrollment changes to a different prescription drug plan or an MA-PD
plan offered by the same parent organization;
(iv) The PDP sponsor will not use the data to inform marketing of
benefits.
(v) The PDP sponsor will contractually bind its contractors that
have access to the Medicare claims data, and any other potential
downstream data recipients, to the terms and conditions imposed on the
PDP Sponsor under this paragraph (g).
(5) Ensuring the privacy and security of data. As a condition of
receiving the requested data, the PDP sponsor must attest that it will
adhere to the permitted uses and limitations on the use of the Medicare
claims data listed in paragraphs (g)(3) and (4) of this section.
0
31. Section 423.182 is amended in paragraph (a) by adding the
definitions of ``Absolute percentage cap'', ``Cut point cap'',
``Guardrail'', ``Mean resampling'', ``Restricted range'', and
``Restricted range cap'' in alphabetical order to read as follows:
Sec. 423.182 Part D Prescription Drug Plan Quality Rating System.
(a) * * *
Absolute percentage cap is a cap applied to non-CAHPS measures that
are on a 0 to 100 scale that restricts movement of the current year's
measure-threshold-specific cut point to no more than the stated
percentage as compared to the prior year's cut point.
* * * * *
Cut point cap is a restriction on the change in the amount of
movement a measure-threshold-specific cut point can make as compared to
the prior year's measure-threshold-specific cut point. A cut point cap
can restrict upward movement, downward movement, or both.
* * * * *
Guardrail is a bidirectional cap that restricts both upward and
downward movement of a measure-threshold-specific cut point for the
current year's measure-level Star Ratings as compared to the prior
year's measure-threshold-specific cut point.
* * * * *
Mean resampling refers to a technique where measure-specific scores
for the current year's Star Ratings are randomly separated into 10
equal-sized groups. The hierarchal clustering algorithm is done 10
times, each time leaving one of the 10 groups out. The method results
in 10 sets of measure-specific cut points. The mean cut point for each
threshold per measure is calculated using the 10 values.
* * * * *
Restricted range is the difference between the maximum and minimum
measure score values using the prior year measure scores excluding
outer fence outliers (first quartile -3 * Interquartile Range (IQR) and
third quartile + 3 * IQR).
Restricted range cap is a cap applied to non-CAHPS measures that
restricts movement of the current year's
[[Page 55086]]
measure-threshold-specific cut point to no more than the stated
percentage of the restricted range of a measure calculated using the
prior year's measure score distribution.
* * * * *
0
32. Section 423.184 is amended by adding paragraphs (f)(1)(iv),
(g)(1)(ii)(M), and (h) to read as follows:
Sec. 423.184 Adding, updating, and removing measures.
* * * * *
(f) * * *
(1) * * *
(iv) CMS will exclude any measure that receives a measure-level
Star Rating reduction for data integrity concerns for either the
current or prior year from the improvement measure(s).
* * * * *
(g) * * *
(1) * * *
(ii) * * *
(M) CMS will reduce a measure rating to 1 star for the applicable
appeals measure(s) if a contract fails to submit Timeliness Monitoring
Project data for CMS's review to ensure the completeness of the
contract's IRE data.
* * * * *
(h) Review of sponsors' data. (1) A request for CMS or the IRE to
review a contract's appeals data must be received no later than June 30
of the following year.
(2) A request for CMS to review a contract's Complaints Tracking
Module (CTM) data must be received no later than June 30 of the
following year.
0
33. Section 423.186 is amended by revising paragraph (a)(2)(i) and
adding paragraph (i) to read as follows:
Sec. 423.186 Calculation of Star Ratings.
(a) * * *
(2) * * *
(i) The method maximizes differences across the star categories and
minimizes the differences within star categories using mean resampling
with the hierarchal clustering of the current year's data, and a
guardrail so that the measure-threshold-specific cut points for non-
CAHPS measures do not increase or decrease more than the value of the
cap from one year to the next. The cap is equal to 5 percentage points
for measures having a 0 to 100 scale (absolute percentage cap) or 5
percent of the restricted range for measures not having a 0 to 100
scale (restricted range cap). New measures that have been in the Part C
and D Star Rating program for three years or less use the hierarchal
clustering methodology with mean resampling with no guardrail for the
first three years in the program.
* * * * *
(i) Extreme and uncontrollable circumstances. In the event of
extreme and uncontrollable circumstances that may negatively impact
operational and clinical systems and contracts' abilities to conduct
surveys needed for accurate performance measurement, CMS will calculate
the Star Ratings as specified in paragraphs (i)(2) through (8) of this
section for each contract that is an affected contract during the
performance period for the applicable measures.
(1) Identification of affected contracts. A contract that meets all
of the following criteria is an affected contract:
(i) The contract's service area is within an ``emergency area''
during an ``emergency period'' as defined in section 1135(g) of the
Act.
(ii) The contract's service area is within a county, parish, U.S.
territory or tribal area designated in a major disaster declaration
under the Stafford Act and the Secretary exercised authority under
section 1135 of the Act based on the same triggering event(s).
(iii) As specified in paragraphs (i)(2) through (8) of this
section, a certain minimum percentage (25 percent or 60 percent) of the
enrollees under the contract must reside in a Federal Emergency
Management Agency (FEMA)-designated Individual Assistance area at the
time of the extreme and uncontrollable circumstance.
(2) CAHPS adjustments. (i) A contract, even if an affected
contract, must administer the CAHPS survey unless exempt under
paragraph (i)(2)(ii) of this section.
(ii) An affected contract will be exempt from administering the
CAHPS survey if the contract completes both of the following:
(A) Demonstrates to CMS that the required sample for the survey
cannot be contacted because a substantial number of the contract's
enrollees are displaced due to the FEMA-designated disaster identified
in paragraph (i)(1)(iii) of this section in the prior calendar year.
(B) Requests and receives a CMS approved exception.
(iii) An affected contract with an exception defined in paragraph
(i)(2)(ii) of this section will receive the contract's CAHPS measure
stars and corresponding measure scores from the prior year.
(iv) For an affected contract with at least 25 percent of enrollees
in FEMA-designated Individual Assistance areas at the time of the
extreme and uncontrollable circumstance, the contract will receive the
higher of the previous year's Star Rating or the current year's Star
Rating (and corresponding measure score) for each CAHPS measure.
(3) New measure adjustments. For affected contracts with at least
25 percent of enrollees in a FEMA-designated Individual Assistance area
at the time of the extreme and uncontrollable circumstance, CMS will
apply a hold harmless provision by comparing the result of the
contract's summary and/or overall rating with and without including all
of the applicable new measures. If the ``with'' result is lower than
the ``without'' result, then CMS will use the ``without'' result as the
final rating.
(4) Other Star Ratings measure adjustments. (i) For all other Part
D measures except those measures identified in this paragraph
(i)(4)(ii) of this section, affected contracts with at least 25 percent
of enrollees in a FEMA-designated Individual Assistance area at the
time of the extreme and uncontrollable circumstance will receive the
higher of the previous or current year's measure Star Rating and then
use the corresponding measure score.
(ii) CMS will not adjust the scores of the Star Ratings for the
Part D Call Center--Foreign Language Interpreter and TTY Availability
measure, unless the exception listed in paragraph (i)(4)(iii) of this
section applies.
(iii) CMS will adjust the measure listed in paragraph (i)(4)(ii) of
this section using the adjustments listed in paragraph (i)(4)(i) of
this section for contracts affected by extreme and uncontrollable
circumstances where there are continuing communications issues related
to loss of electricity and damage to infrastructure during the call
center study.
(5) Exclusion from improvement measures. Any measure that reverts
back to the data underlying the previous year's Star Rating due to the
adjustments made in paragraph (i) of this section will be excluded from
both the count of measures and the applicable improvement measures for
the current and next year's Star Ratings for the affected contract.
(6) Missing data. For an affected contract that has missing data in
the current or previous year, the final measure rating will come from
the current year unless an exception described in paragraph (i)(2)(ii)
of this section applies.
(7) Cut points for non-CAHPS measures. (i) CMS will exclude the
numeric values for affected contracts with 60 percent or more of their
enrollees in the FEMA-designated Individual Assistance area at the time
of the extreme and uncontrollable
[[Page 55087]]
circumstance from the clustering algorithms described in paragraph
(a)(2) of this section.
(ii) The cut points calculated as described in paragraph (i)(7)(i)
of this section will be used to assess all affected contracts' measure
Star Ratings.
(8) Reward factor. (i) CMS will exclude the numeric values for
affected contracts with 60 percent or more of their enrollees in the
FEMA-designated Individual Assistance area at the time of the extreme
and uncontrollable circumstance from the determination of the
performance summary and variance thresholds for the reward factor
described in paragraph (f)(1) of this section.
(ii) All affected contracts will be eligible for the reward factor
based on the calculations described in paragraph (i)(8)(i) of this
section.
0
34. Section 423.568 is amended by revising paragraph (b) to read as
follows:
Sec. 423.568 Standard timeframe and notice requirements for coverage
determinations.
* * * * *
(b) Timeframe for requests for drug benefits. When a party makes a
request for a drug benefit, the Part D plan sponsor must notify the
enrollee (and the prescribing physician or other prescriber involved,
as appropriate) of its determination as expeditiously as the enrollee's
health condition requires, but no later than 72 hours after receipt of
the request. For an exceptions request, the Part D plan sponsor must
notify the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of its determination as expeditiously as the
enrollee's health condition requires, but no later than 72 hours after
receipt of the physician's or other prescriber's supporting statement
or 14 calendar days after receipt of the request, whichever occurs
first.
* * * * *
0
35. Section 423.570 is amended by revising paragraph (d)(1) to read as
follows:
Sec. 423.570 Expediting certain coverage determinations.
* * * * *
(d) * * *
(1) Make the determination within the 72-hour timeframe established
in Sec. 423.568(b) for a standard determination. The 72-hour period
begins on the day the Part D plan sponsor receives the request for
expedited determination. For an exceptions request, the Part D plan
sponsor must notify the enrollee (and the prescribing physician or
other prescriber involved, as appropriate) of its determination as
expeditiously as the enrollee's health condition requires, but no later
than 72 hours after receipt of the physician's or other prescriber's
supporting statement or 14 calendar days after receipt of the request,
whichever occurs first.
* * * * *
0
36. Section 423.572 is amended by revising paragraph (a) to read as
follows:
Sec. 423.572 Timeframes and notice requirements for expedited
coverage determinations.
(a) Timeframe for determination and notification. Except as
provided in paragraph (b) of this section, a Part D plan sponsor that
approves a request for expedited determination must make its
determination and notify the enrollee (and the prescribing physician or
other prescriber involved, as appropriate) of its decision, whether
adverse or favorable, as expeditiously as the enrollee's health
condition requires, but no later than 24 hours after receiving the
request. For an exceptions request, the Part D plan sponsor must notify
the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of its determination as expeditiously as the
enrollee's health condition requires, but no later than 24 hours after
receipt of the physician's or other prescriber's supporting statement
or 14 calendar days after receipt of the request, whichever occurs
first.
* * * * *
PART 438--MANAGED CARE
0
37. The authority for part 438 is revised to read as follows:
Authority: 42 U.S.C. 1302.
0
38. Section 438.210 is amended by--
0
a. Revising paragraphs (c) and (d) introductory text;
0
b. Adding paragraph (d)(4); and
0
c. Revising paragraph (f).
The addition and revisions read as follows:
Sec. 438.210 Coverage and authorization of services.
* * * * *
(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. For Medicaid contracts with an
applicable integrated plan, as defined in Sec. 422.561 of this
chapter, in lieu of the provisions in this paragraph governing notices
of adverse benefit determinations, the provisions set forth in
Sec. Sec. 422.629 through 422.634 of this chapter apply to
determinations affecting dually eligible individuals who are also
enrolled in a dual eligible special needs plan with exclusively aligned
enrollment, as defined in Sec. 422.2 of this chapter.
(d) Timeframe for decisions. Each MCO, PIHP, or PAHP contract must
provide for the following decisions and notices:
* * * * *
(4) For Medicaid contracts with an applicable integrated plan, as
defined in Sec. 422.561 of this chapter, timelines for decisions and
notices must be compliant with the provisions set forth in in
Sec. Sec. 422.629 through 422.634 of this chapter in lieu of
Sec. Sec. 438.404 through 438.424.
* * * * *
(f) Applicability date. (1) Subject to paragraph (f)(2) of this
section, 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.
(2) Provisions in this section affecting applicable integrated
plans, as defined in Sec. 422.561 of this chapter, are applicable no
later than January 1, 2021.
0
39. Section 438.400 is amended by adding paragraph (a)(4) and revising
paragraph (c) to read as follows:
Sec. 438.400 Statutory basis, definitions, and applicability.
(a) * * *
(4) Section 1859(f)(8)(B) of the Act requires that the Secretary,
to the extent feasible, establish procedures unifying grievances and
appeals procedures under sections 1852(f), 1852(g), 1902(a)(3),
1902(a)(5), and 1932(b)(4) of the Act for items and services provided,
by specialized MA plans for special needs individuals described in
section 1859(b)(6)(B)(ii), under Titles XVIII and XIX of the Act.
* * * * *
(c) Applicability. (1) Subject to paragraph (c)(2) of this section,
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.
(2) Provisions in this section affecting applicable integrated
plans, as defined
[[Page 55088]]
in Sec. 422.561 of this chapter, are applicable no later than January
1, 2021.
0
40. Section 438.402 is amended by revising paragraph (a) to read as
follows:
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. An applicable integrated plan as defined
in Sec. 422.561 of this chapter is not subject to this subpart F, and
is instead subject to the requirements of Sec. Sec. 422.629 through
422.634 of this chapter.
* * * * *
PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT
AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE
MEDICAID PROGRAM
0
41. The authority for part 498 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7j, and 1395hh.
0
42. Section 498.5 is amended by revising paragraph (n)(1) to read as
follows:
Sec. 498.5 Appeal rights.
* * * * *
(n) * * *
(1)(i) Any individual or entity that is dissatisfied with an
initial determination or revised initial determination that they are to
be included on the preclusion list (as defined in Sec. 422.2 or Sec.
423.100 of this chapter) may request a reconsideration in accordance
with Sec. 498.22(a).
(ii)(A) If the individual's or entity's inclusion on the preclusion
list is based on a Medicare revocation under Sec. 424.535 of this
chapter and the individual or entity receives contemporaneous notice of
both actions, the individual or entity may request a joint
reconsideration of both the preclusion list inclusion and the
revocation in accordance with Sec. 498.22(a).
(B) The individual or entity may not submit separate
reconsideration requests under paragraph (n)(1)(ii)(A) of this section
for inclusion on the preclusion list or a revocation if the individual
or entity received contemporaneous notice of both actions.
* * * * *
Dated: October 17, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: October 18, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-23599 Filed 10-26-18; 4:15 pm]
BILLING CODE 4120-01-P