[Federal Register Volume 89, Number 50 (Wednesday, March 13, 2024)]
[Notices]
[Pages 18411-18412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10279, CMS-10316 and CMS-10008]


Agency Information Collection Activities: Proposed Collection; 
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 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates 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 must be received by May 13, 2024.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    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 N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10279 Ambulatory Surgical Center Conditions for Coverage
CMS-10316 Implementation of the Medicare Prescription Drug Plan (PDP) 
and Medicare Advantage (MA) Plan Disenrollment Reasons Survey
CMS-10008 Transitional Pass-through payments related to Drugs, 
Biologicals, and Radiopharmaceuticals to determine eligibility under 
the Outpatient Prospective Payment System

    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collection

    1. Type of Information Collection Request: Reinstatement with 
changes to a previously approved collection; Title of Information 
Collection: Ambulatory Surgical Center Conditions for Coverage; Use: 
The purpose of this package is to request from the Office of Management 
and Budget (OMB) the approval to reinstate, with changes, the 
collection of

[[Page 18412]]

information. The Cfc for ASCs are regulation based on criteria 
described and codified at Sec.  42 CFR 416. The Cfc establish standards 
designed to ensure that each ASC has properly trained staff to provide 
the appropriate type and level of care for the environment of ASC 
patients.
    To determine ASC compliance with CMS standards, CMS, via the 
Secretary, authorizes States, through contracts, to survey ASC 
facilities. For Medicare purposes, certification is based on the State 
survey agency's recording of an ASC provider's compliance or non-
compliance with the health and safety Cfc as published and codified in 
42 CFR 416.40 to 485.54. The information collections aid surveyors as 
they assess ASC compliance or non-compliance.
    The previous iteration of this information collection request had a 
burden of 262,946 annual hours at an annual cost of $28,144,370. For 
this requested reinstatement, with changes, the adjusted annual hourly 
burden is 97,527 hours at a cost of $11,089,427. The reasons for this 
change, is the previous iteration of this IC assumed the development 
associated with IC-1 and IC-2 occurred frequently. We have revised this 
as development of drafts only occur on a one-time basis. Form Number: 
CMS-10279 (OMB control number: 0938-1071); Frequency: Annual; Affected 
Public: Business or other for-profit and Not-for-profit institutions; 
Number of Respondents: 6,257; Total Annual Responses: 6,257; Total 
Annual Hours: 97,527. (For policy questions regarding this collection 
contact Claudia Molinar at 410-786-8445.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Implementation of 
the Medicare Prescription Drug Plan (PDP) and Medicare Advantage (MA) 
Plan Disenrollment Reasons Survey; Use: Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) provides a requirement 
to collect and report performance data for Part D prescription drug 
plans. Specifically, the MMA under Sec. 1860D-4 (Information to 
Facilitate Enrollment) requires CMS to conduct consumer satisfaction 
surveys regarding the PDP and MA contracts pursuant to section 1860D-
4(d). Plan disenrollment is generally believed to be a broad indicator 
of beneficiary dissatisfaction with some aspect of plan services, such 
as access to care, customer service, cost of the plan, services, 
benefits provided, or quality of care.
    This data collection complements the enrollee beneficiary 
experience data collected through the Medicare Consumer Assessment of 
Healthcare Providers and Systems (Medicare CAHPS) survey by providing 
information on the reasons for disenrollment from a Medicare Advantage 
(with or without prescription drug coverage) or Prescription Drug Plan.
    The Disenrollment Survey results are an important source of 
information used by CMS to monitor contract performance and to identify 
potential problems (e.g., plans providing incorrect information to 
beneficiaries or creating access problems). CMS uses the results to 
monitor the quality of service that Medicare beneficiaries get from 
contracted plans and their providers and to understand beneficiaries' 
expectations relative to provided benefits and services for MA and 
PDPs. CMS uses information from the Disenrollment Survey to support 
quality improvement efforts of individual contracts. Form Number: CMS-
10316 (OMB control number: 0938-1113); Frequency: Yearly; Affected 
Public: Individuals and Households; Number of Respondents: 36,050; 
Total Annual Responses: 36,050; Total Annual Hours: 6,730. (For policy 
questions regarding this collection contact Beth Simon at 415-744-
3780.)
    3. 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. 2024-05291 Filed 3-12-24; 8:45 am]
BILLING CODE 4120-01-P