[Federal Register Volume 89, Number 102 (Friday, May 24, 2024)]
[Notices]
[Pages 45898-45899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11397]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10185 and CMS-10008]


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

[[Page 45899]]

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 June 24, 2024.

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: Medicare Part D 
Reporting Requirements; Use: Section 1860D-12(b)(3)(D) of the Act 
provides broad authority for the Secretary to add terms to the 
contracts with Part D sponsors, including terms that require the 
sponsor to provide the Secretary with information as the Secretary may 
find necessary and appropriate. Pursuant to our statutory authority, we 
codified these information collection requirements for Part D sponsors 
in regulation at 42 CFR 423.514(a).
    Data collected via the Medicare Part D reporting requirements will 
be an integral resource for oversight, monitoring, compliance, and 
auditing activities necessary to ensure quality provision of the 
Medicare Prescription Drug Benefit to beneficiaries. For all reporting 
sections (Enrollment and Disenrollment, Medication Therapy Management 
(MTM) Programs, Grievances, Improving Drug Utilization Review Controls, 
Coverage Determinations and Redeterminations, and Employer/Union 
Sponsored Sponsors, and Medicare Prescription Payment Plan), data are 
reported electronically to CMS. The data collected via the MTM and 
Grievances reporting sections are used in the Medicare Part C and D 
Star Ratings and Display Measures. The other reporting sections' data 
are analyzed for program oversight to ensure the availability, 
accessibility, and acceptability of sponsors' services, such as 
coverage determinations and appeals processes, and opioid safety edits 
at the time of dispensing. Form Number: CMS-10185 (OMB Control Number: 
0938-0992); Frequency: Yearly; Affected Public: Business or other for-
profits; Number of Respondents: 1,019; Number of Responses: 14,325; 
Total Annual Hours: 23,094. (For policy questions regarding this 
collection contact Abigale Sanft at 410-786-6068.)
    2. Type of Information Collection Request: Extension currently 
approved collection; Title of Information Collection: Transitional Pass 
through payments related to Drugs, Biologicals, and 
Radiopharmaceuticals to determine eligibility under the Outpatient 
Prospective Payment System; Use: Section 1833(t)(6)(D)(i) of the Act 
sets the payment rate for pass-through eligible drugs and biologicals 
(assuming that no pro rata reduction in pass-through payment is 
necessary) as the amount determined under section 1842(o) of the Act. 
Section 303(c) of Public Law 108-173 amended Title XVIII of the Act by 
adding new section 1847A. This new section establishes the use of the 
average sales price (ASP) methodology for payment for drugs and 
biologicals described in section 1842(o)(1)(C) of the Act furnished on 
or after January 1, 2005. Therefore, as we stated in the November 15, 
2004 Federal Register (69 FR 65776), in CY 2005, we will pay under the 
OPPS for drugs, biologicals and radiopharmaceuticals with pass-through 
status consistent with the provisions of section 1842(o) of the Act as 
amended by Public Law 108-173 at a rate that is equivalent to the 
payment these drugs and biologicals will receive in the physician 
office setting, and established in accordance with the methodology 
described in the CY 2005 Physician Fee Schedule final rule.
    Interested parties such as hospitals, pharmaceutical companies, and 
physicians will apply for transitional pass-through payment for drugs, 
biologicals, and radiopharmaceuticals used with services covered under 
the hospital OPPS. After we receive all requested information, we will 
evaluate the information to determine if the criteria for making a 
transitional pass-through payment are met and if an interim healthcare 
common procedure coding system (HCPCS) code for a new drug, biological, 
or radiopharmaceutical is necessary. We will advise the applicant of 
our decision and update the hospital OPPS during its next scheduled 
quarterly update to reflect any newly approved drug, biological, or 
radiopharmaceutical. Based on experience gained in processing 
transitional pass-through and new technology applications, we have 
reworded some of the statements for clarity and have more clearly 
requested information in a format that will allow us to determine if 
the drug, biological, or radiopharmaceutical meets the cost 
significance test, as well as to estimate the associated pass-through 
payment amount. In addition, we have also eliminated the requirement 
for applicants to obtain a national Level II HCPCS code prior to 
seeking transitional pass-through payment eligibility or provide us 
with a copy of their application for a national HCPCS code, as we had 
originally required in the April 7, 2000, final rule. Form Number: CMS-
10008 (OMB control number: 0938-0802); Frequency: Once; Affected 
Public: Private Sector, Business or other for-profit and Not-for-profit 
institutions; Number of Respondents: 35; Total Annual Responses: 35; 
Total Annual Hours: 560. (For policy questions regarding this 
collection contact Andrew Wang at 410-786-8233.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-11397 Filed 5-23-24; 8:45 am]
BILLING CODE 4120-01-P