Notice2021-19012
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 2, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 168 (Thursday, September 2, 2021)</title>
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[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49332-49333]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html</a>
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
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