Notice2023-22791
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
October 16, 2023
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 88 Issue 198 (Monday, October 16, 2023)</title>
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[Federal Register Volume 88, Number 198 (Monday, October 16, 2023)]
[Notices]
[Pages 71367-71368]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</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 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
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