[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Notices]
[Pages 76946-76947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26743]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10191 and CMS-10305]


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

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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: The 
necessity and utility of the proposed information collection for the 
proper performance of the agency's functions; the accuracy of the 
estimated burden; ways to enhance the quality, utility, and clarity of 
the information to be collected; and the use of automated collection 
techniques or other forms of information technology to

[[Page 76947]]

minimize the information collection burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by December 5, 2016.

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) 395-5806 OR, Email: 
[email protected].
    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: 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: Revision of a currently 
approved collection; Title of Information Collection: Medicare Parts C 
and D Program Audit Protocols and Data Requests; Use: Under the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
and implementing regulations at 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 CMS to 
develop an audit strategy to ensure we continue to obtain meaningful 
audit results. As a result, CMS' audit strategy reflected a move to a 
more targeted, data-driven and risk-based audit approach. We focused on 
high-risk areas that have the greatest potential for beneficiary harm.
    To maximize resources, CMS will focus on assisting the industry to 
improve their operations to ensure beneficiaries receive access to 
care. One way to accomplish this is CMS will develop an annual audit 
strategy which describes how sponsors will be selected for audit and 
the areas that will be audited. CMS has developed several audit 
protocols and these are posted to the CMS Web site each year for use by 
sponsors to prepare for their audit. Currently CMS utilizes the 
following 7 protocols to audit sponsor performance: Formulary 
Administration (FA), Coverage Determinations, Appeals & Grievances 
(CDAG), Organization Determination, Appeals and Grievances (ODAG), 
Special Needs Model of Care (SNPMOC) (only administered on 
organizations who operate SNPs), Compliance Program Effectiveness 
(CPE), Medication Therapy Management (MTM) and Provider Network 
Accuracy (PNA). The data collected is detailed in each of these 
protocols and the exact fields are located in the record layouts, at 
the end of each protocol. In addition, questionnaires are distributed 
as part of our CDAG, ODAG and CPE audits. These questionnaires are also 
included in this package.
    As part of a robust audit process, CMS also requires sponsors who 
have been audited and found to have deficiencies to undergo a 
validation audit to ensure correction. The validation audit utilizes 
the same audit protocols, but only tests the elements where 
deficiencies were found, as opposed to re-administering the entire 
audit. Finally, to assist in improving the audit process, CMS sends 
sponsors a link to a survey (Appendix D) at the end of each audit to 
complete in order to obtain the sponsors' feedback. The sponsor is not 
required to complete the survey. Form Number: CMS-10191 (OMB control 
number: 0938-1000); Frequency: Yearly; Affected Public: Private Sector 
(business or other for-profit and not-for-profit institutions); Number 
of Respondents: 40; Total Annual Responses: 40; Total Annual Hours: 
13,640. (For policy questions regarding this collection contact Dawn 
Johnson at 410-786-3159.)
    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 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.)

    Dated: November 1, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-26743 Filed 11-3-16; 8:45 am]
 BILLING CODE 4120-01-P