[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49332-49333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10241 and CMS-10174]


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

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
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 (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 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 on the collection(s) of information must be received by 
the OMB desk officer by October 4, 2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

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: Survey of Retail 
Prices; Use: This information collection request provides for a survey 
of the average acquisition costs of all covered outpatient drugs 
purchased by retail community pharmacies. CMS may contract with a 
vendor to conduct monthly surveys of retail prices for covered 
outpatient drugs. Such prices

[[Page 49333]]

represent a nationwide average of consumer purchase prices, net of 
discounts and rebates. The contractor shall provide notification when a 
drug product becomes generally available and that the contract include 
such terms and conditions as the Secretary shall specify, including a 
requirement that the vendor monitor the marketplace. CMS has developed 
a National Average Drug Acquisition Cost (NADAC) for states to consider 
when developing reimbursement methodology. The NADAC is a pricing 
benchmark that is based on the national average costs that pharmacies 
pay to acquire Medicaid covered outpatient drugs. This pricing 
benchmark is based on drug acquisition costs collected directly from 
pharmacies through a nationwide survey process. This survey is 
conducted on a monthly basis to ensure that the NADAC reference file 
remains current and up-to-date. Form Number: CMS-10241 (OMB control 
number 0938-1041); Frequency: Monthly; Affected Public: Private sector 
(Business or other for-profits); Number of Respondents: 72,000; Total 
Annual Responses: 72,000; Total Annual Hours: 36,000. (For policy 
questions regarding this collection contact: Lisa Shochet at 410-786-
5445.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Collection of 
Prescription Drug Event Data From Contracted Part D Providers for 
Payment; Use: The PDE data is used in the Payment Reconciliation System 
to perform the annual Part D payment reconciliation, any PDE data 
within the Coverage Gap Phase of the Part D benefit is used for 
invoicing in the CGDP, and the data are part of the report provided to 
the Secretary of the Treasury for Section 9008.
    CMS has used PDE data to create summarized dashboards and tools, 
including the Medicare Part D Drug Spending Dashboard & Data, the Part 
D Manufacturer Rebate Summary Report, and the Medicare Part D Opioid 
Prescribing Mapping Tool. The data are also used in the Medicare 
Trustees Report. Due to the market sensitive nature of PDE data, 
external uses of the data are subject to significant limitations. 
However, CMS does analyze the data on a regular basis to determine drug 
cost and utilization patterns in order to inform programmatic patterns 
and to develop informed policy in the Part D program.
    The information users will be Pharmacy Benefit Managers (PBMs), 
third party administrators and pharmacies, and the PDPs, MA-PDs, 
Fallbacks and other plans that offer coverage of outpatient 
prescription drugs under the Medicare Part D benefit to Medicare 
beneficiaries. The statutorily required data is used primarily for 
payment and is used for claim validation as well as for other 
legislated functions such as quality monitoring, program integrity and 
oversight. Form Number: CMS-10174 (OMB control number: 0938-0982); 
Frequency: Yearly; Affected Public: Businesses or other for-profits, 
Not-for-profit institutions; Number of Respondents: 739; Total Annual 
Responses: 1,499,238,090; Total Annual Hours: 2,998. (For policy 
questions regarding this collection contact Ivan Iveljic at 410-786-
3312.)

    Dated: August 30, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-19012 Filed 9-1-21; 8:45 am]
BILLING CODE 4120-01-P