[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Notices]
[Pages 40064-40068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16514]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-R-218, CMS-10428, CMS-10441, CMS-10261, CMS-
10338, CMS-10137, CMS-10237 and CMS-10003]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS) is publishing the following summary of proposed 
collections for public comment. Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

[[Page 40065]]

    1. Type of Information Collection Request: Extension without change 
of a currently approved collection. Title of Information Collection: 
HIPAA Standards for Electronic Transactions and Supporting Regulations 
in 45 CFR Part 162. Use: This information collection request has no 
substantive changes since the last OMB approval. The adopted 
transaction standards currently in use for electronic transactions 
(Version 4010/4010a) are compatible with the ICD-9-CM adopted code set 
that is used to report diagnoses and hospital inpatient services. 
However, the ICD-10 codes cannot be used with Version 4010/4010a, 
because this version does not have a specific qualifier or indicator 
for reporting ICD-10 codes.
    Version 5010 supports the use of the ICD-10 code set by making 
available a qualifier to indicate that an ICD-10 code is being 
reported. Like ICD-9, ICD-10 codes are reported in claim and payment 
transactions, as well as eligibility inquiries and responses and 
requests for referrals and authorizations. In Version 5010, the number 
of codes required in any given transaction does not change. It is 
possible that a fewer number of codes in a given transaction may be 
necessary to report the same information reported with ICD-9 codes 
because ICD-10 codes are more specific. Form Number: CMS-R-218 (OCN: 
0938-0866). Frequency: Occasionally. Affected Public: Private Sector 
(Business or other for-profits, Not-for-profit institutions). Number of 
Respondents: 696,026. Total Annual Responses: 696,026. Total Annual 
Hours: 6,960,260. (For policy questions regarding this collection 
contact Gladys Wheeler at 410-786-0273. For all other issues call 410-
786-1326.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title: PCIP Authorization to Share Personal Health 
Information; Use: On March 23, 2010, the President signed into law H.R. 
3590, the Patient Protection and Affordable Care Act (Affordable Care 
Act), Public Law 111-148. Section 1101 of the law establishes a 
``temporary high risk health insurance pool program'' (which has been 
named the Pre-Existing Condition Insurance Plan, or PCIP) to provide 
health insurance coverage to currently uninsured individuals with pre-
existing conditions. The law authorizes HHS to carry out the program 
directly or through contracts with states or private, non-profit 
entities.
    Reapproval of this package is being requested as a result of CMS, 
in its administration of the PCIP program, serving as a covered entity 
under the Health Insurance Portability and Accountability Act (HIPAA). 
Without a valid authorization, the PCIP program is unable to disclose 
information, with respect to an applicant or enrollee, about the status 
of an application, enrollment, premium billing or claim, to individuals 
of the applicant's or enrollee's choosing. The HIPAA Authorization Form 
has been modeled after CMS' Medicare HIPAA Authorization Form (OMB 
control number 0938-0930) and is used by applicants or enrollees to 
designate someone else to communicate with PCIP about their protected 
health information (PHI).
    Unless permitted or required by law, the Health Insurance 
Portability and Accountability Act (HIPAA) Privacy Rule (Sec.  164.508) 
prohibits CMS' PCIP program (a HIPAA covered entity) from disclosing an 
individual's protected health information without a valid 
authorization. In order to be valid, an authorization must include 
specified core elements and statements.
    CMS will make available to PCIP applicants and enrollees a 
standard, valid authorization to enable beneficiaries to communicate 
with PCIP about their personal health information. This is a critical 
tool because the population the PCIP program serves is comprised of 
individuals with pre-existing conditions who may be incapacitated and 
need an advocate to help them apply for or receive benefits from the 
program. This standard authorization will simplify the process of 
requesting information disclosure for beneficiaries and minimize the 
response time for the PCIP program.
    Each individual will be asked to complete the form which will 
include providing the individual's name, PCIP account number (if 
known), date of birth, what personal health information they agree to 
share, the length of time the individual agrees their personal health 
information can be shared, the names and addresses of the third party 
the individual wants PCIP to share their personal health information 
with, and an attestation that the individual is giving PCIP permission 
to share their personal health information with the third party listed 
in the form. This completed form will be submitted to the PCIP benefits 
administrator, GEHA, which contracts with CMS.
    We estimate that it will take approximately 15 minutes per 
applicant to complete and submit a HIPAA Authorization Form to the PCIP 
program.
    The federally-run PCIP program operates in 23 states plus the 
District of Columbia and receives an average of 35,000 enrollment 
applications per year. To estimate the number of PCIP applicants and 
enrollees who may complete an authorization, we looked at the 
percentage of individuals who request an authorization in Medicare as a 
baseline. Medicare estimates 3% of its population will submit an 
authorization per year. However, since the PCIP program caters to an 
exclusive population comprised of individuals who have one or more pre-
existing conditions, we believe it is likely we could receive double 
the percentage estimated by Medicare. Accordingly, PCIP estimates 6% 
(or 2,100) of its applicants and enrollees may submit an authorization 
per year.
    Based on the above, it is estimated that up to 2,100 applicants and 
enrollees may submit an authorization annually. There is no cost to 
PCIP beneficiaries to request, complete, submit, or have the 
authorization form processed by PCIP. It should take approximately 15 
minutes for a beneficiary to complete the authorization form. 15 
minutes multiplied by 2,100 beneficiaries equals 525 hours. Form 
Number: CMS-10428 (OCN: 0938-1161); Frequency: Reporting--
Once; Affected Public: Individuals or households; Number of 
Respondents: 2,100; Total Annual Responses: 2,100; Total Annual Hours: 
525. (For policy questions regarding this collection contact Geoffrey 
Cabin at 410-786-1744. For all other issues call 410-786-1326.)
    3. Type of Information Collection Request: New collection; Title: 
Medicare Plan Finder Experiment; Use: The mission of the Centers for 
Medicare & Medicaid Services (CMS) is to ensure the provision of health 
care to its beneficiaries. Recent legislative mandates, including the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
require CMS to provide information to beneficiaries about the quality 
of the Medicare health and prescription drug plans. To provide that 
information, all Medicare health and prescription drug plans with an 
enrollment of 600 or more are required to collect and report data 
following protocols that CMS has established. CMS has also contracted 
with various organizations to develop valid and reliable quality 
measures and to consider how best to report those measures to 
beneficiaries.
    A primary vehicle for reporting quality information to 
beneficiaries is the Medicare Plan Finder, a section of the Medicare 
Web site that is intended to help beneficiaries make informed choices 
among health and prescription drug plans. The Medicare Plan Finder

[[Page 40066]]

tool contains a great deal of potentially useful information, including 
extensive data on the fixed and variable costs associated with being 
enrolled in plans, the benefits and coverage that plans offer, and the 
quality of service that plans provide, as revealed by member experience 
data, disenrollment statistics, and a variety of measures of clinical 
processes and outcomes.
    One of the key challenges that CMS has faced is how to engage 
beneficiaries with the quality information provided in the Medicare 
Plan Finder. Among the possible reasons that beneficiaries may fail to 
engage with this information are first, that several steps are required 
for a user of the Medicare Plan Finder to gain access to comparative 
plan information, and second that once the user does reach a data 
display, the amount of information presented is voluminous, and can 
seem overwhelming.
    This study will use an experimental design to assess the 
effectiveness of two potential enhancements to the Medicare Plan Finder 
tool that may help address these barriers to engagement and use of 
quality information. The purpose of this experiment is to test the 
effects of two prospective enhancements to the Medicare Plan Finder 
(MPF) Web site. We refer to these prospective enhancements as the 
``Quick Links'' home page and the ``enhanced data display.'' Form 
Number: CMS-10441 (OCN: 0938-New); Frequency: Reporting--Once; 
Affected Public: Individuals or Households; Number of Respondents: 600; 
Total Annual Responses: 600; Total Annual Hours: 252. (For policy 
questions regarding this collection contact David Miranda at 410-786-
7819. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title: Part C Medicare Advantage Reporting 
Requirements and Supporting Regulations in 42 CFR Sec.  422.516(a); 
Use: The Centers for Medicare and Medicaid Services (CMS) established 
reporting requirements for Medicare Advantage Organizations (MAOs) 
under the authority described in 42 CFR Sec.  422.516(a). It is noted 
that each MAO must have an effective procedure to develop, compile, 
evaluate, and report to CMS, to its enrollees, and to the general 
public, at the times and in the manner that CMS requires, and while 
safeguarding the confidentiality of the doctor-patient relationship, 
statistics and other information with respect to the cost of its 
operations, patterns of service utilization, availability, 
accessibility, and acceptability of its services, developments in the 
health status of its enrollees, and other matters that CMS may require.
    CMS also has oversight authority over cost plans which includes 
establishment of reporting requirements. The data requirements in this 
supporting statement are specifically relevant to the cost plan 
requirements in section 1876(c)(1)(C) of the Social Security Act which 
establishes beneficiary enrollment and appeal rights.
    CMS initiated new Part C reporting requirements with the Office of 
Management and Budget (OMB) approval of the ``Information Collection 
Request'' (ICR) under the Paperwork Reduction Act of 1995 (PRA) in 
December, 2008 (OMB 0938-New; CMS-10261). National PACE plans 
and 1833 cost plans are excluded from reporting all the new Part C 
Reporting Requirements measures. The initial ICR involved thirteen 
measures. Two of these thirteen measures have been suspended from 
reporting because the information is available elsewhere: Measurement 
10 Agent Compensation Structure and; Measurement 11 
Agent Training and Testing. One new measure was added beginning 2012: 
Enrollment and Disenrollment. The ICR Reference number is 201105-0938-
008. The OMB control number is 0938-1054.
    CMS suspended the ``Benefit Utilization'' measure in late 2011. 
Thus, calendar year 2011 benefit utilization data were not reported. 
This suspension remains in effect and will lead to a reduction in 
burden. CMS is requesting the suspension of two additional measures: 
``Procedure Frequency'' and Provider Network Adequacy.'' The 
suspensions are all due to the fact that equivalent data are already 
being collected or are available through other sources in CMS. These 
suspensions will lead to a decrease in burden. CMS is adding one 
additional data element to its ``grievances'' measure. The grievance 
measure currently has 10 reporting categories. The additional category 
will be ``CMS Issues.'' This will add a slight increase to burden for 
this measure only. Overall, the approval of this ICR will lead to an 
estimated burden reduction of 88,730 hours and $5,420,095 in costs on 
an annual basis. Form Number: CMS-10261 (OCN: 0938-1054); 
Frequency: Yearly, Quarterly; Affected Public: Private Sector--Business 
or other for-profits; Number of Respondents: 1,375; Total Annual 
Responses: 6,715; Total Annual Hours: 120,190. (For policy questions 
regarding this collection contact Terry Lied at 410-786-8973. For all 
other issues call 410-786-1326.)
    5. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Affordable Care Act Internal Claims and Appeals and External Review 
Procedures for Non-grandfathered Group Health Plans and Issuers and 
Individual Market Issuers; Use: The Patient Protection and Affordable 
Care Act, Public Law 111-148, (the Affordable Care Act) was enacted by 
President Obama on March 23, 2010. As part of the Act, Congress added 
PHS Act section 2719, which provides rules relating to internal claims 
and appeals and external review processes. On July 23, 2010, interim 
final regulations (IFR) set forth rules implementing PHS Act section 
2719 for internal claims and appeals and external review processes. 
With respect to internal claims and appeals processes for group health 
coverage, PHS Act section 2719 and paragraph (b)(2)(i) of the interim 
final regulations provide that group health plans and health insurance 
issuers offering group health insurance coverage must comply with the 
internal claims and appeals processes set forth in 29 CFR 2560.503-1 
(the DOL claims procedure regulation) and update such processes in 
accordance with standards established by the Secretary of Labor in 
paragraph (b)(2)(ii) of the regulations. The DOL claims procedure 
regulation requires an employee benefit plan to provide third-party 
notices and disclosures to participants and beneficiaries of the plan. 
In addition, paragraphs (b)(3)(ii)(C) and (b)(2)(ii)(C) of the IFR add 
an additional requirement that non-grandfathered group health plans and 
issuers of non-grandfathered health policies provide to the claimant, 
free of charge, any new or additional evidence considered, or generated 
by the plan or issuer in connection with the claim. Paragraph (b)(3)(i) 
of the IFR requires issuers offering coverage in the individual health 
insurance market to also generally comply with the DOL claims procedure 
regulation as updated by the Secretary of HHS in paragraph (b)(3)(ii) 
of the IFR for their internal claims and appeals processes.
    Furthermore, PHS Act section 2719 and the IFR provide that non-
grandfathered group health plans, issuers offering group health 
insurance coverage, and self-insured non-federal governmental plans 
(through the IFR amendment dated June 24, 2011) must comply either with 
a State external review process or a Federal external review process. 
The IFR provides a basis for determining when such plans and issuers 
must comply with an applicable

[[Page 40067]]

State external review process and when they must comply with the 
Federal external review process. Plans and issuers that are required to 
participate in the Federal external review process must have 
electronically elected either the HHS-administered process or the 
private accredited IRO process as of January 1, 2012, or, in the 
future, at such time as the plans and issuers use the Federal external 
review process. Plans and issuers must notify HHS as soon as possible 
if any of the above information changes at any time after it is first 
submitted. The election requirements associated with this ICR are 
articulated through guidance published June 22, 2011 at http://cciio.cms.gov/resources/files/hhs_srg_elections_06222011.pdf. The 
election requirements are necessary for the Federal external review 
process to provide an independent external review as requested by 
claimants. Form Number: CMS-10338 (OCN: 0938-1099); Frequency: 
Occasionally; Affected Public: State, Local, Tribal Governments; 
Business or other for-profit; Not-for-profit institutions; Number of 
Respondents: 46,773; Number of Responses: 218,657,161; Total Annual 
Hours: 930,267. For policy questions regarding this collection, contact 
Colin McVeigh at (301) 492-4263. For all other issues call (410) 786-
1326.
    6. Type of Information Collection Request: Revision of a currently 
approved collection; Title: Application for New and Expanding Medicare 
Prescription Drug Plans and Medicare Advantage Prescription Drug (MA-
PD), including Cost Plans and Employer Group Waiver Plans; Use: The 
Medicare Prescription Drug Benefit program was established by section 
101 of the Medicare Prescription Drug, Improvement, and Modernization 
Act of 2003 (MMA) and is codified in section 1860D of the Social 
Security Act (the Act). Section 101 of the MMA amended Title XVIII of 
the Social Security Act by redesignating Part D as Part E and inserting 
a new Part D, which establishes the voluntary Prescription Drug Benefit 
Program (``Part D''). The MMA was amended on July 15, 2008 by the 
enactment of the Medicare Improvements for Patients and Providers Act 
of 2008 (MIPPA), on March 23, 2010 by the enactment of the Patient 
Protection and Affordable Care Act and on March 30, 2010 by the 
enactment the Health Care and Education Reconciliation Act of 2010 
(collectively the Affordable Care Act).
    Coverage for the prescription drug benefit is provided through 
contracted prescription drug plans (PDPs) or through Medicare Advantage 
(MA) plans that offer integrated prescription drug and health care 
coverage (MA-PD plans). Cost Plans that are regulated under Section 
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP) 
may also provide a Part D benefit. Organizations wishing to provide 
services under the Prescription Drug Benefit Program must complete an 
application, negotiate rates, and receive final approval from CMS. 
Existing Part D Sponsors may also expand their contracted service area 
by completing the Service Area Expansion (SAE) application.
    Collection of this information is mandated in Part D of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA) in Subpart 3. The application requirements are codified in 
Subpart K of 42 CFR 423 entitled ``Application Procedures and Contracts 
with PDP Sponsors.''
    Effective January 1, 2006, the Part D program established an 
optional prescription drug benefit for individuals who are entitled to 
Medicare Part A or enrolled in Part B. In general, coverage for the 
prescription drug benefit is provided through PDPs that offer drug-only 
coverage, or through MA organizations that offer integrated 
prescription drug and health care coverage (MA-PD plans). PDPs must 
offer a basic drug benefit. Medicare Advantage Coordinated Care Plans 
(MA-CCPs) must offer either a basic benefit or may offer broader 
coverage for no additional cost. Medicare Advantage Private Fee for 
Service Plans (MA-PFFS) may choose to offer a Part D benefit. Cost 
Plans that are regulated under Section 1876 of the Social Security Act, 
and Employer Group Plans may also provide a Part D benefit. If any of 
the contracting organizations meet basic requirements, they may also 
offer supplemental benefits through enhanced alternative coverage for 
an additional premium.
    Applicants may offer either a PDP or MA-PD plan with a service area 
covering the Nation (i.e., offering a plan in every region) or covering 
a limited number of regions. MA-PD and Cost Plan applicants may offer 
local plans.
    There are 34 PDP regions and 26 MA regions in which PDPs or 
regional MA-PDs may be offered respectively. The MMA requires that each 
region have at least two Medicare prescription drug plans from which to 
choose, and at least one of those must be a PDP. Requirements for 
contracting with Part D Sponsors are defined in Part 423 of 42 CFR.
    This clearance request is for the information collected to ensure 
applicant compliance with CMS requirements and to gather data used to 
support determination of contract awards. Form Number: CMS-10137 (OCN: 
0938-0936); Frequency: Yearly; Affected Public: Private Sector--
Business or other for-profits and Not-for-profit institutions; Number 
of Respondents: 241; Total Annual Responses: 241; Total Annual Hours: 
2,132. (For policy questions regarding this collection contact Linda 
Anders at 410-786-0459. For all other issues call 410-786-1326.)
    7. Type of Information Collection Request: Revision of a currently 
approved collection. Title of Information Collection: Part C Medicare 
Advantage and 1876 Cost Plan Expansion Application; Use: Collection of 
this information is mandated in Part C of the Medicare Prescription 
Drug, Improvement and Modernization Act of 2003 (MMA) in Subpart K of 
42 CFR 422 entitled ``Contracts with Medicare Advantage 
Organizations.'' In addition, the Medicare Improvements for Patients 
and Providers Act of 2008 (MIPPA) amended titles XVII and XIX of the 
Social Security Act to improve the Medicare program.
    In general, coverage for the prescription drug benefit is provided 
through prescription drug plans (PDPs) that offer drug-only coverage or 
through Medicare Advantage (MA) organizations that offer integrated 
prescription drug and health care products (MA-PD plans). PDPs must 
offer a basic drug benefit. Medicare Advantage Coordinated Care Plans 
(MA-CCPs) either must offer a basic benefit or may offer broader 
coverage for no additional cost. Medicare Advantage Private Fee for 
Service Plans (MA-PFFS) may choose to offer enrollees a Part D benefit. 
Employer Group Plans may also provide Part D benefits. If any of the 
contracting organizations meet basic requirements, they may also offer 
supplemental benefits through enhanced alternative coverage for an 
additional premium.
    Organizations wishing to provide healthcare services under MA and/
or MA-PD plans must complete an application, file a bid, and receive 
final approval from CMS. Existing MA plans may request to expand their 
contracted service area by completing the Service Area Expansion (SAE) 
application. Applicants may offer a local MA plan in a county, a 
portion of a county (i.e., a partial county) or multiple counties. 
Applicants may offer a MA regional plan in one or more of the 26 MA 
regions.
    This clearance request is for the information collected to ensure

[[Page 40068]]

applicant compliance with CMS requirements and to gather data used to 
support determination of contract awards. Form Number: CMS-10237 (OCN 
0938-0935). Frequency: Yearly. Affected Public: Private Sector 
(Business or other for-profits, Not-for-profit institutions). Number of 
Respondents: 566. Total Annual Responses: 566. Total Annual Hours: 
22,955. (For policy questions regarding this collection contact Barbara 
Gullick at 410-786-0563. For all other issues call 410-786-1326.)
    8. Type of Information Collection Request: Revision of a currently 
approved collection. Title of Information Collection: Notice of Denial 
of Medical Coverage (or Payment); Use: Section 1852(g)(1)(B) of the 
Social Security Act (SSA) requires Medicare health plans to provide 
enrollees with a written notice in understandable language that 
explains the plan's reasons for denying a request for a service or 
payment for a service the enrollee has already received. The written 
notice must also include a description of the applicable appeals 
processes. Regulatory authority for this notice is set forth in Subpart 
M of Part 422 at 42 CFR 422.568, 422.572, 417.600(b), and 417.840.
    Section 1932 of the Social Security Act (SSA) sets forth 
requirements for Medicaid managed care plans, including beneficiary 
protections related to appealing a denial of coverage or payment. The 
Medicaid managed care appeals regulations are set forth in Subpart F of 
Part 438 of Title 42 of the CFR. Rules on the content of the written 
denial notice can be found at 42 CFR Sec.  438.404.
    This notice combines the existing Notice of Denial of Medicare 
Coverage with the Notice of Denial of Payment and includes optional 
language to be used in cases where a Medicare health plan enrollee also 
receives full Medicaid benefits that are being managed by the Medicare 
health plan. Form Number: CMS-10003 (OCN: 0938-0829). Frequency: 
Occasionally. Affected Public: Private Sector (Business or other for-
profits, Not-for-profit institutions). Number of Respondents: 665. 
Total Annual Responses: 6,960,410. Total Annual Hours: 1,159,604. (For 
policy questions regarding this collection contact Gladys Wheeler at 
410-786-0273. For all other issues call 410-786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, 
or Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected], or call 
the Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by September 4, 2012:
    1. Electronically. You may submit your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number ------------------, Room C4-26-05, 7500 Security 
Boulevard, Baltimore, Maryland 21244-1850.

    Dated: June 29, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-16514 Filed 7-5-12; 8:45 am]
BILLING CODE 4120-01-P