Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

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

# AGENCY:

Centers for Medicare & Medicaid Services, Health and Human 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 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                           ( print 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