[Federal Register Volume 84, Number 193 (Friday, October 4, 2019)]
[Notices]
[Pages 53156-53157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-262 and CMS-10662]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

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 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 minimize the information collection 
burden.

DATES: Comments must be received by December 3, 2019.

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' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    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: William N. Parham at (410) 786-4669.

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-R-262 Contract Year 2021 Plan Benefit Package (PBP) Software and 
Formulary Submission

[[Page 53157]]

CMS-10662 Administrative Simplification HIPAA Compliance Review

    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 with change of 
a currently approved collection; Title of Information Collection: 
Contract Year 2021 Plan Benefit Package (PBP) Software and Formulary 
Submission; Use: Under the Medicare Modernization Act (MMA), Medicare 
Advantage (MA) and Prescription Drug Plan (PDP) organizations are 
required to submit plan benefit packages for all Medicare beneficiaries 
residing in their service area. The plan benefit package submission 
consists of the Plan Benefit Package (PBP) software, formulary file, 
and supporting documentation, as necessary. MA and PDP organizations 
use the PBP software to describe their organization's plan benefit 
packages, including information on premiums, cost sharing, 
authorization rules, and supplemental benefits. They also generate a 
formulary to describe their list of drugs, including information on 
prior authorization, step therapy, tiering, and quantity limits.
    CMS requires that MA and PDP organizations submit a completed PBP 
and formulary as part of the annual bidding process. During this 
process, organizations prepare their proposed plan benefit packages for 
the upcoming contract year and submit them to CMS for review and 
approval. CMS uses this data to review and approve the benefit packages 
that the plans will offer to Medicare beneficiaries. This allows CMS to 
review the benefit packages in a consistent way across all submitted 
bids during with incredibly tight timeframes. This data is also used to 
populate data on Medicare Plan Finder, which allows beneficiaries to 
access and compare Medicare Advantage and Prescription Drug plans. Form 
Number: CMS-R-262 (OMB control number: 0938-0763); Frequency: Yearly; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 672; Total Annual Responses: 7,264; Total Annual Hours: 
67,368. (For policy questions regarding this collection contact Kristy 
L. Holtje at 410-786-2209.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Administrative Simplification HIPAA Compliance Review; Use: The 
authority for administering and enforcing compliance with the 
Administrative Simplification non-privacy Health Insurance Portability 
and Accountability Act (HIPAA) rules has been delegated to the Centers 
for Medicare & Medicaid Services (CMS). (68 FR 60694 Part F, October 
23, 2003) 45 CFR 160.308 states, ``that the Secretary may conduct 
compliance reviews to determine whether covered entities are complying 
with the applicable administrative simplification provisions.'' These 
reviews are conducted at the discretion of the Secretary. Title 45 CFR 
160.310 requires that a covered entity provide records and compliance 
reports to the Secretary in cooperation with a compliance review. Title 
45 CFR 160.310 provides that a covered entity must permit HHS, or its 
delegated entity, access during normal business hours to its 
facilities, books, records, and other information, and other 
information necessary to determine compliance, but also provides that 
if the Secretary determines that ``exigent circumstances exist, such as 
when documents may be hidden or destroyed,'' the covered entity must 
permit access at any time without notice.
    The purpose of this collection is to retrieve information necessary 
to conduct a compliance review as described in CMS-0014-N (68 FR 
60694). These forms will be submitted to the Centers for Medicare & 
Medicaid Services (CMS), Program Management National Standards Group, 
from entities covered by HIPAA Administrative Simplification 
regulations. This collection is not applicable to HIPAA Privacy and 
Security Rules. Form Number: CMS-10662 (OMB control number: 0938-New); 
Frequency: Occasionally; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 10; Total Annual Responses: 10; 
Total Annual Hours: 425. (For policy questions regarding this 
collection contact Cecily Austin at 410-786-0895.)

    Dated: October 1, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-21687 Filed 10-3-19; 8:45 am]
 BILLING CODE 4120-01-P