[Federal Register Volume 88, Number 198 (Monday, October 16, 2023)]
[Notices]
[Pages 71367-71368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10241 and CMS-10717]


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 November 15, 2023.

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, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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 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 includes 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: Robert Giles at 667-290-8626.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare Part C 
and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring 
Project (TMP) Protocols; 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. CMS' annual audit plan ensures that we 
evaluate sponsoring organizations' compliance with these requirements 
by conducting program audits that focus on high-risk areas that have 
the greatest potential for beneficiary harm. As such, CMS has developed 
the following audit protocols for use by sponsoring organizations to 
prepare for their audit:

<bullet> Compliance Program Effectiveness (CPE)
<bullet> Part D Formulary and Benefit Administration (FA)
<bullet> Part D Coverage Determinations, Appeals, and Grievances (CDAG)

[[Page 71368]]

<bullet> Part C Organization Determinations, Appeals, and Grievances 
(ODAG)
<bullet> Special Needs Plans Care Coordination (SNPCC)

    CMS generally conducts program audits at the parent organization 
level in an effort to reduce burden and, for routine audits, subjects 
each sponsoring organization to all applicable program area protocols. 
For example, if a sponsoring organization does not offer a special 
needs plan, or an accrediting organization has deemed a special needs 
plan compliant with CMS regulations and standards, CMS would not apply 
the SNPCC protocol. Likewise, CMS would not apply the ODAG audit 
protocol to an organization that offers only a standalone prescription 
drug plan since that organization does not offer the MA benefit. 
Conversely, ad hoc audits resulting from referral may be limited in 
scope and, therefore, all program area protocols may not be applied.
    The information gathered during this program audit will be used by 
the Medicare Parts C and D Oversight and Enforcement Group (MOEG) 
within the Center for Medicare (CM) and CMS Regional Offices to assess 
sponsoring organizations' compliance with Medicare program 
requirements. If outliers or other data anomalies are detected, 
Regional Offices will work in collaboration with MOEG and other 
divisions within CMS for follow-up and resolution. Additionally, MA and 
Part D organizations will receive the audit results and will be 
required to implement corrective action to correct any identified 
deficiencies. Form Number: CMS-10717 (OMB control number: 0938-1395); 
Frequency: Yearly; Affected Public: Private Sector, State, Local, or 
Tribal Governments, Federal Government, Business or other for-profits, 
Not-for-Profit Institutions; Number of Respondents: 182; Total Annual 
Responses: 182; Total Annual Hours: 36,444. (For policy questions 
regarding this collection contact Matthew Guerand, at 303-844-7120.)

    Dated: October 11, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-22791 Filed 10-13-23; 8:45 am]
BILLING CODE 4120-01-P