[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42710-42711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15564]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10260, CMS-10305 and CMS-10622]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates 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 must be received by August 29, 2016.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send 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) that are 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.
    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 [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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

SUPPLEMENTARY INFORMATION: 

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10260 Medicare Advantage and Prescription Drug Program: Final 
Marketing Provisions in 42 CFR 422.111(a)(3) and 423.128(a)(3)
CMS-10305 Medicare Part C and Part D Data Validation (42 CFR 422.516(g) 
and 423.514(g))
CMS-10622 Evaluation of the CMS Quality Improvement Organizations: 
Reducing Healthcare-Acquired Conditions in Nursing Homes

    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage and Prescription Drug Program: Final Marketing Provisions in 
42 CFR 422.111(a)(3) and 423.128(a)(3); Use: We require that Medicare 
Advantage (MA) organizations and Part D sponsors use standardized 
documents to satisfy disclosure requirements mandated by section 1851 
(d)(3)(A) of the Social Security Act (Act) and 42 CFR 422.111(b) for MA 
organizations, and section 1860D-1(c) of the Act and 42 CFR 
423.128(a)(3) for Part D sponsors. The regulatory provisions require 
that MA organizations and Part D sponsors disclose plan information, 
including: Service area, benefits, access, grievance and appeals 
procedures, and quality improvement and quality assurance requirements 
by September 30th of each year. The MA organizations and Part D 
sponsors use the information to comply with the disclosure 
requirements. We will use the approved standardized documents to ensure 
that correct information is disclosed to current and potential 
enrollees.
    For 2017, CMS has a total of nine standardized ANOC/EOC documents: 
Health Maintenance Organization, Cost, Dual Eligible Special Needs, 
Medicare Medical Savings Account, Private-Fee-For-Service, Preferred 
Provider Organizations, Preferred Provider Organization with 
Prescription Drugs, Health Maintenance Organization with Prescription 
Drug, and Prescription Drug. These standardized documents will be used 
by MA organizations and Part D sponsors for the 2018 contract year.
    In revising the standardized ANOC/EOCs for contract year 2018, we 
did not add to or remove any section from the prior contract year ANOC/
EOC models. MA organizations and Part D sponsors are still required to 
use the standardized language in the ANOC/EOC models and to send this 
document to current members at least 15 days prior to the start of the 
annual enrollment period or by September 30, 2017 for the 2018 
enrollment season, based on 42 CFR 422.111(a) (3) and 423.128(a)(3). 
Form Number: CMS-10260 (OMB control number: 0938-1051); Frequency: 
Yearly; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 805; Total Annual Responses: 805; 
Total Annual Hours: 9,660. (For policy questions regarding this 
collection contact Gladys Valentin at 410-786-1620.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part C 
and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)); Use: 
Organizations contracted to offer

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Medicare Part C and Part D benefits are required to report data to us 
on a variety of measures. For the data to be useful for monitoring and 
performance measurement, the data must be reliable, valid, complete, 
and comparable among sponsoring organizations. To meet this goal, we 
have developed reporting standards and data validation specifications 
with respect to the Part C and Part D reporting requirements. These 
standards provide a review process for Medicare Advantage 
Organizations, Cost Plans, and Part D sponsors to use to conduct data 
validation checks on their reported Part C and Part D data.
    The FDCF is revised for the 2017 and 2018 DV collection periods by 
changing the scoring of six standards from a binary scale to a five-
point Likert-type scale. This change is expected to improve the 
precision of the data validation scores by increasing overall variation 
in total scores among the MAOs and PDPs. The revision is not expected 
to alter resource requirements, since the assessment by DV contractors 
in scoring standards will continue to be based on the percentage of 
records that meet the standards. Form Number: CMS-10305 (OMB control 
number: 0938-1115); Frequency: Yearly; Affected Public: Private 
sector--Business or other for-profits; Number of Respondents: 639; 
Total Annual Responses: 639; Total Annual Hours: 209,271. (For policy 
questions regarding this collection contact Terry Lied at 410-786-
8973.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Evaluation of the 
CMS Quality Improvement Organizations: Reducing Healthcare-Acquired 
Conditions in Nursing Homes; Use: As mandated by Sections 1152-1154 of 
the Social Security Act, CMS directs the QIO program, one of the 
largest federal programs dedicated to improving health quality for 
Medicare beneficiaries. In the 11th SOW, CMS restructured the QIO 
program to funded Quality Innovation Networks (QIN)-QIOs, Beneficiary 
and Family-Centered Care (BFCC) organizations, National Coordinating 
Centers (NCCs), Program Collaboration Centers (PCCs), and the Strategic 
Innovation Engine (SIE). In the current SOW, 14 QIN-QIOs coordinate the 
work of 53 QIOs nationwide including all 50 states and other U.S. 
territories.
    CMS evaluates the quality and effectiveness of the QIO program as 
authorized in Part B of Title XI of the Social Security Act. CMS 
created the Independent Evaluation Center (IEC) to provide CMS and its 
stakeholders with an independent and objective program evaluation of 
the 11th SOW. Evaluation activities will focus on analyzing how well 
the QIO program is achieving the three aims of better care, better 
health, and lower cost as well as the effectiveness of the new QIO 
program structure. One of the QIN-QIOs' tasks to achieve these three 
aims is to support participating nursing homes in their efforts to 
improve quality of care and health outcomes among residents. According 
to the 2013 CMS Nursing Home Data Compendium, more than 15,000 nursing 
homes participated in Medicare and Medicaid programs with more than 1.4 
million beneficiaries resided in U.S. nursing homes. These residents 
and their families rely on nursing homes to provide reliable, safe, 
high quality care. However, cognitive and functional impairments, pain, 
incontinence, antipsychotic drug use, and healthcare associated 
conditions (HAC), such as pressure ulcers and falls, remain areas of 
concern.
    This information collection is to provide data to assess QIN-QIOs 
efforts aimed at addressing these HACs in nursing homes. QIN-QIOs are 
responsible for recruiting nursing homes to participate in the program. 
We will conduct an annual survey of administrators of nursing homes 
participating in the QIN-QIO program (intervention group) and 
administrators at nursing homes that are not participating in the QIN-
QIO program (comparison group). Our proposed survey assesses progress 
towards the goals of the QIN-QIO SOW, including activities and 
strategies to increase mobility among residents, reduce infections, 
reduce use of inappropriate antipsychotic medication among long-term 
stay residents.
    We plan to conduct qualitative interviews with nursing home 
administrators. This interview will supplement the Nursing Home Survey 
and provide more in-depth contextual information about the QIN-QIO 
program implementation within at nursing homes, including: (i) Their 
experience with, and perceived success of QIN-QIO collaboratives; (ii) 
their satisfaction with the QIN-QIO Collaborative and QIO support; 
(iii) perceived value and impact of QIO program; and (iv) drivers and 
barriers to QIN-QIO involvement and success.
    Information from QIO leadership and/or state/territory task leads 
will be collected by interviews and focus groups. Interviews with 
Nursing Home Task leaders at the QIN and QIO will be conducted in-
person during site visits and/or over the phone. We will conduct focus 
groups with QIO-level Directors during the annual CMS Quality 
conference. The purpose of the interviews and focus groups is to 
examine: (i) QIO processes for recruiting nursing homes, peer coaches, 
and beneficiaries to participate in the program; (ii) strengths and 
challenges of QIN-QIO activities related to nursing homes; (iii) 
partnership and coordination with other QIN-QIO tasks; and (iv) overall 
lessons learned. We will also conduct qualitative interviews with 
nursing home peer coaches. Form Number: CMS-10622 (OMB control number: 
0938-NEW); Frequency: Annually; Affected Public: Business or other for-
profits and Not-for Profits institutions; Number of Respondents: 856; 
Total Annual Responses: 856; Total Annual Hours: 242. (For policy 
questions regarding this collection contact Robert Kambic at 410-786-
1515.)

    Dated: June 27, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-15564 Filed 6-29-16; 8:45 am]
 BILLING CODE 4120-01-P