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[Federal Register Volume 78, Number 138 (Thursday, July 18, 2013)]
[Notices]
[Pages 42957-42959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17317]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10062, CMS-10146, CMS-10191, CMS-10308, CMS-R-
43 and CMS-10453]

Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the 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.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by August 19, 2013:

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974, or Email: OIRA_submission@omb.eop.gov .
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Collection of Diagnostic Data from Medicare Advantage 
Organizations for Risk

[[Page 42958]]

Adjusted Payments; Use: In the Balanced Budget Act of 1997 (BBA), 
Congress created the Medicare+Choice (M+C or Part C) program in order 
to expand the types of private entities eligible to contract with 
Medicare and to address some perceived flaws in the risk-contracting 
program. Congress subsequently refined the M+C program through the 
Balanced Budget Refinement Act of 1999 (BBRA) and the Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 
(BIPA). Most recently, under the Medicare Prescription Drug Benefit, 
Improvement and Modernization Act of 2003 (MMA), Congress restructured 
the M+C program into the Medicare Advantage (MA) program and added an 
outpatient prescription drug benefit, Part D.
    The BBA of 1997 and later legislation required CMS to adjust per-
beneficiary capitation payments with a risk adjustment methodology 
using diagnoses to measure relative risk due to health status instead 
of just demographic characteristics such as age, sex, and Medicaid 
eligibility. Risk adjustment using diagnoses provides more accurate 
payments for MA organizations, with higher payments for enrollees at 
risk for being sicker, and lower payments for enrollees predicted to be 
healthier.
    The MMA also instituted a bidding system in Parts C and D with a 
significant role for risk adjustment. Thus, independent of enrollment 
and payment, risk adjustment now plays a significant role simply 
because it is central to the bidding process. Under the MMA, risk 
adjustment is used to standardize bids. Plans bid on the average 
beneficiary, referred to as a ``standardized'' bid for a beneficiary 
with a 1.0 risk score. This enables comparison of Part C and D bids 
against a baseline (average) standard, even though every plan will have 
different enrollee characteristics and benefit packages and will 
therefore have different costs.
    Previously, we received PRA clearance to collect inpatient and 
outpatient data for Part C using the CMS-HCC model. Currently, we are 
seeking to renew that OMB approval and also clearance for changes in 
data collection in order to fulfill new mandates under the MMA. Form 
Number: CMS-10062 (OCN: 0938-0838); Frequency: Quarterly; Affected 
Public: Private Sector (business or other for-profit and not-for-profit 
institutions); Number of Respondents: 766; Total Annual Responses: 
830,000; Total Annual Hours: 40,650; (For policy questions regarding 
this collection contact Michael Massimini at 410-786-1566.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection;
    Title of Information Collection: Notice of Denial of Medicare 
Prescription Drug Coverage; Use: Section 1860D-4(g)(1) of the Social 
Security Act, requires that Part D plan sponsors who deny prescription 
drug coverage must provide a written notice of the denial to the 
enrollee. The written notice must include a statement, in 
understandable language, of the reasons for the denial and a 
description of the appeals process. The Part D denial notice has been 
revised for clarity and includes new optional language for Part D plan 
sponsors to use when explaining their denial rationale. Specifically, 
we added optional language in the denial rationale section of the 
notice to allow plans to populate text explaining that a drug denied 
under Part D may be (or is) covered under a different benefit, such as 
Part B. The instructions have also been changed to guide plans on when 
to use this optional text. We solicit feedback on this new addition as 
well as other situations where another benefit may cover a drug (i.e. 
employer group benefits) and what changes to the denial notice may be 
helpful in addressing those situations. We also seek comment regarding 
the potential viability and usefulness of developing a combined notice 
for Part C and Part D, which would allow MA-PD plans that deny a drug 
under Part D to simultaneously issue an approval letter under Part B. 
Form Number: CMS-10146 (OCN: 0938-0976); Frequency: Occasionally; 
Affected Public: Private sector (business or other for-profits); Number 
of Respondents: 596; Total Annual Responses: 1,497,929; Total Annual 
Hours: 374,482; (For policy questions regarding this collection contact 
Caroline Baker at 410-786-0116.)
    3. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Medicare Parts C and D Universal Audit Guide; Use: Under 
the Medicare Prescription Drug, Improvement, and Modernization Act of 
2003 and implementing regulations under 42 CFR parts 422 and 423, 
Medicare Part D plan sponsors and Medicare Advantage organizations are 
required to comply with all Medicare Parts C and D program 
requirements. In 2010 the explosive growth of these sponsoring 
organizations forced us to develop an audit strategy to ensure we 
continue to obtain meaningful audit results. As a result, our audit 
strategy reflected a move to a more targeted, data-driven and risk-
based audit approach that focused on high-risk areas having the 
greatest potential for beneficiary harm.
    To accomplish this we have combined all Part C and Part D audit 
elements into one universal guide which will also promote consistency, 
effectiveness and reduce financial and time burdens for both CMS and 
Medicare-contracting entities. The combined Medicare Part C & D 
Universal Audit Guide received OMB approval in 2010. The Health Plan 
Management System (HPMS) is the current conduit by which organizations 
submit many sources of audit materials such as bids and other ongoing 
updates to us. Please note the guide is very comprehensive in that it 
describes all areas that could be audited. Due to limited resources, we 
are unable to audit all areas for any particular sponsor. Some areas 
could be monitored by the account manager, etc. Other areas could be 
the audited in the program audits.
    To maximize resources, we will focus on assisting the industry to 
improve their operations to ensure beneficiaries receive access to 
care. We will accomplish this by developing an annual audit strategy 
which describes how sponsors will be selected for audit and the areas 
that will be audited. The audit strategy will be shared with the 
industry via the CMS Web site, HPMS memo, the Part C & D user call, and 
other conferences. Once the audit areas are defined, we will design 
audit protocols describing in detail the focus of the audit, the data 
required for the audit, etc. The Engagement Letter and Protocols will 
be sent to all sponsors selected for audit 4 weeks prior to starting 
the audit. In addition, the protocols will be released to the industry 
at the beginning of each calendar year via the same manner as the audit 
strategy. To assist in improving the audit process, we send the plan 
sponsors a survey at the end of each audit to complete in order to 
obtain the sponsors feedback. The sponsor is not required to complete 
the survey. The supporting materials for this information collection 
request have been revised since the 60-day Federal Register notice 
published on February 28, 2013 (78 FR 4412). Form Number: CMS-10191 
(OCN: 0938-1000); Frequency: Yearly; Affected Public: Private Sector 
(business or other for-profit and not-for-profit institutions); Number 
of Respondents: 195; Total Annual Responses: 195; Total Annual Hours: 
24,180. (For policy questions regarding this collection contact Tracey 
Roberts at 410-786-8643.)

[[Page 42959]]

    4. Type of Information Collection Request: Revision of a currently 
approved collection. Title of Information Collection: Parts C and D 
Complaints Resolution Performance Measures. Use: We seek to conduct a 
survey as part of the Part C and D Complaints Resolution Performance 
Measure project. The purpose of the project is to develop and support 
implementation of internal monitoring tools for the Medicare Advantage 
(Part C) and Prescription Drug (Part D) program that represents, from 
the beneficiary's perspective, the way in which plans handle 
complaints. The data collection is necessary because a survey is the 
only way to collect information about the resolution process from the 
beneficiary's perspective. Currently, there is no other data source 
that collects such information for Part C and Part D Medicare plans. 
Form Number: CMS-10308 (OCN: 0938-1107); Frequency: Yearly; Affected 
Public: Individuals or households; Number of Respondents: 18,210; Total 
Annual Responses: 18,210; Total Annual Hours: 3,035. (For policy 
questions regarding this collection contact Carolyn Scott at 410-786-
1190.)
    5. Type of Information Collection Request: Reinstatement with 
change of a currently approved collection; Title of Information 
Collection: Conditions of Coverage for Portable X-ray Suppliers and 
Supporting Regulations; Use: The requirements contained in this 
information collection request are classified as conditions of 
participation or conditions for coverage. These conditions are based on 
a provision specified in law relating to diagnostic X-ray tests 
``furnished in a place of residence used as the patient's home,'' and 
are designed to ensure that each supplier has a properly trained staff 
to provide the appropriate type and level of care, as well as, a safe 
physical environment for patients. We use these conditions to certify 
suppliers of portable X-ray services wishing to participate in the 
Medicare program. This is standard medical practice and is necessary in 
order to help to ensure the well-being, safety and quality professional 
medical treatment accountability for each patient. Form Number: CMS-R-
43 (OCN: 0938-0338); Frequency: Yearly; Affected Public: Business or 
other for-profit and Not-for-profit institutions; Number of 
Respondents: 578; Total Annual Responses: 578; Total Annual Hours: 948. 
(For policy questions regarding this collections contact Alesia 
Hovatter at 410-786-6861.)
    6. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: The 
Medicare Advantage and Prescription Drug Program: Part C Explanation of 
Benefits CFR 422.111(b)(12); Use: We are requesting OMB approval for 
the information collection requirements referenced in the April 15, 
2011 final rule revising the Medicare Advantage (MA) and Part D 
programs for calendar year 2012 (77 FR 21432-21577). The rule revised 
the MA disclosure requirements in 42 CFR 422.111(b) by adding the 
authority for CMS to require MA organizations to furnish a written 
explanation of benefits directly to enrollees, in a manner we specify 
and in a form easily understandable to enrollees, when benefits are 
provided under Part 422. The collection instrument that requires OMB 
approval concerns the disclosure requirements in paragraph 42 CFR 
422.111(b)(12).
    In order to provide all Medicare Advantage enrollees with 
consistent, clear, useful information about their medical claims, we 
established a requirement, in the April 2011 final rule, that MA 
organizations furnish directly to enrollees, in the manner specified by 
CMS and in a form easily understandable to such enrollees, a written 
explanation of benefits, when benefits are provided under Part 422. We 
finalized this policy based on the public comments and input we have 
received from beneficiaries, advocacy organizations, health plans and 
industry organizations. This EOB will help ensure that people in the 
Medicare Advantage program receive clear, timely information, as do 
people receiving the Medicare MSN and the Part D EOB, so that they may 
make confident, informed decisions about their healthcare options.
    We stated that we would develop a model EOB for Part C benefits 
modeled after the EOB currently required for Part D enrollees at Sec.  
423.128(e). After publication of the final rule in April 2011, we 
engaged MA organizations, industry and advocacy groups and 
beneficiaries in listening sessions to gather ideas and feedback. We 
developed models based on that input, as well as the newly redesigned 
and consumer tested Medicare Summary Notice and the Part D EOB. We have 
tested models through a small pilot program with a volunteer MA 
organization in CY 2012. In designing our model EOB, we considered 
language and design from Medicare MSN, integration of Part C and Part D 
EOBs, level of detail, and frequency of EOB dissemination as part of 
this process.
    We sought additional public comments on the model EOBs that we 
developed through a Health Plan Management System (HPMS) memo release 
with a 30 day comment period. Our goal was to implement a model Part C 
EOB document in mid-year 2013 based on this process, and to require all 
MA organizations to periodically send an EOB to enrollees for Part C 
benefits in future years. This customized information would supplement 
general plan information in the annual notice of change (ANOC) and 
evidence of coverage (EOC) documents as well as enhance the currently 
available information through tools such as Medicare Options Compare 
(MOC) and the Medicare Prescription Drug Plan Finder (MPDPF), which 
provide general information about plan costs. Based on public comments 
we received on the HPMS memo and November 26, 2012 Federal Register 
notice (77 FR 70445) and the revisions we made to the initial templates 
and guidance, we are extending the timeline for implementation to 
April, 2014. We intend for the Part C EOB to provide personal 
information to beneficiaries that would help them understand their 
current utilization, keep track of their out-of-pocket expenses, and to 
consider using other tools and resources, including MOC and MPDPF, to 
determine whether to select a new plan.
    As a result of comments received during the 60-day comment period 
associated with the November 26, 2012, Federal Register notice (77 FR 
70445), we revised the collection request. Specifically, we shortened 
the templates by removing two sections. One section was deemed to 
include information that was not needed and information from the second 
section was incorporated into other sections. We clarified and 
streamlined the presentation of the information and modified some of 
the language to be more beneficiary-friendly. Form Number: CMS-10453 
(OCN: 0938-New); Frequency: On occasion; Affected Public: Private 
Sector--Business or other for-profits; Number of Respondents: 564; 
Number of Responses: 2,256; Total Annual Hours: 101,520. (For policy 
questions regarding this collection contact Chris McClintick at 410-
786-4682.)

    Dated: July 15, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-17317 Filed 7-17-13; 8:45 am]
BILLING CODE 4120-01-P
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