[Federal Register Volume 88, Number 103 (Tuesday, May 30, 2023)]
[Notices]
[Pages 34502-34504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10728, CMS-10834, CMS-4040, CMS-R-297 and 
CMS-2728]


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 June 29, 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.

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    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: Extension of a currently 
approved collection; Title of Information Collection: Value in Opioid 
Use Disorder Treatment Demonstration; Use: Value in Opioid Use Disorder 
Treatment (Value in Treatment) is a 4-year demonstration program 
authorized under section 1866F of the Social Security Act (Act), which 
was added by section 6042 of the Substance Use-Disorder Prevention that 
Promotes Opioid Recovery and Treatment for Patients and Communities Act 
(SUPPORT Act). The purpose of Value in Treatment, as stated in the 
statute, is to ``increase access of applicable beneficiaries to opioid 
use disorder treatment services, improve physical and mental health 
outcomes for such beneficiaries, and to the extent possible, reduce 
Medicare program expenditures.'' As required by statute, Value in 
Treatment was implemented January 1, 2021. Section 1866F(c)(1)(A)(ii) 
specifies that individuals and entities must apply for and be selected 
to participate in the Value in Treatment demonstration pursuant to an 
application and selection process established by the Secretary.
    Section 1866F(c)(2)(B)(iii) specifies that in order to receive CMF 
and performance-based incentive payments under the Value in Treatment 
program, each participant shall report data necessary to: monitor and 
evaluate the Value in Treatment program; determine if criteria are met; 
and determine the performance-based incentive payment. Form Number: 
CMS-10728 (OMB control number: 0938-1388); Frequency: Annually; 
Affected Public: Individuals and Households; Number of Respondents: 
388; Total Annual Responses: 388; Total Annual Hours: 282. (For policy 
questions regarding this collection contact Rebecca VanAmburg) at 410-
786-0524.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Requirement for Electronic Prescribing for Controlled Substances (EPCS) 
for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD 
Plan; Use: Section 2003 of the SUPPORT for Patients and Communities Act 
of 2018 requires that prescribing of a Schedule II, III, IV, and V 
controlled substance under Medicare Part D be done electronically in 
accordance with an electronic prescription drug program beginning 
January 1, 2021, subject to any exceptions, which HHS may specify. In 
the calendar year (CY) 2021 and 2022 Physician Fee Schedule (PFS) final 
rules, CMS finalized the electronic prescribing for controlled 
substances (EPCS) requirements and exceptions at 42 CFR 423.160(a)(5). 
Compliance for prescribers not in long-term care facilities begins in 
CY 2023. Compliance for prescribers in long-term care facilities begins 
in CY 2025.
    EPCS requirements do not require prescribers or pharmacies to 
submit additional data to CMS; however, CMS did finalize one exception 
that requires data collection. The EPCS exception, at Sec.  
423.160(a)(5)(iv), requires a prescriber to apply for a waiver if the 
prescriber is unable to conduct EPCS due to circumstances beyond the 
prescriber's control. This collection of information is necessary to 
provide adequate and timely exception from the EPCS requirements if the 
prescriber is unable to conduct EPCS due to circumstances beyond the 
prescriber's control. Form Number: CMS-10834 (OMB control number: 0938-
NEW); Frequency: Annually; Affected Public: Private Sector (Business or 
other for-profits, Not-for-Profit Institutions), and Public sector 
(State, Local or Tribal Governments); Number of Respondents: 100; Total 
Annual Responses: 100; Total Annual Hours: 17. (For policy questions 
regarding this collection contact Mei Zhang at (410) 786-7837).
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Request for 
Enrollment in Supplementary Medical Insurance (SMI); Use: CMS 
regulations 42 CFR 407.11 lists the CMS-4040 as the application to be 
used by individuals who are not eligible for monthly Social Security/
Railroad Retirement Board benefits or free Part A. The CMS-4040 
solicits the information that is used to determine entitlement for 
individuals who meet the requirements in section 1836 as well as the 
entitlement of the applicant or their spouses to an annuity paid by OPM 
for premium deduction purposes. The application follows the application 
questions and requirements used by SSA. This is done not only for 
consistency purposes but to comply with other Title II and Title XVIII 
requirements because eligibility to Title II benefits and free Part A 
under Title XVIII must be ruled out in order to qualify for enrollment 
in Part B only. Form Number: CMS-4040 (OMB control number: 0938-0245); 
Frequency: Once; Affected Public: Individuals or households; Number of 
Respondents: 42,011; Total Annual Responses: 42,011; Total Annual 
Hours: 10,503. (For policy questions regarding this collection contact 
Carla Patterson at 410-786-8911.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Request for 
Employment Information; Use: The form CMS-L564, also referred to as 
CMS-R-297, is used, in conjunction with form CMS-40-B, Application for 
Supplementary Medical Insurance, during an individual's special 
enrollment period (SEP). Completed by an employer, the CMS-L564 
provides proof of an applicant's employer group health coverage. The 
Social Security Administration (SSA) uses it to obtain information from 
employers regarding whether a Medicare beneficiary's coverage under a 
group health plan is based on current employment status. The form is 
available online via Medicare.gov and CMS.gov for individuals who are 
requesting the SEP to obtain and submit to their employer for 
completion. The employer must complete and sign the form, and submit it 
to the individual to accompany their enrollment or late enrollment 
penalty reduction request. The information on the completed form is 
reviewed

[[Page 34504]]

manually by SSA. Form Number: CMS-R-297 (OMB control number: 0938-
0787); Frequency: Once; Affected Public: Individuals or households, 
Business or other for-profits, Not-for-profit institutions; Number of 
Respondents: 676,526; Total Annual Responses: 676,526; Total Annual 
Hours: 56,355. (For policy questions regarding this collection contact 
Carla Patterson at 410-786-8911.)
    5. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: End Stage Renal Disease Medical Evidence Report Medicare 
Entitlement and/or Patient Registration; Use: Section 226A (2) of the 
Social Security Act specifically states that a person must be 
``medically determined to have end stage renal disease. . . .'' 
Similarly, Section 188(a) of the law states ``The benefits provided by 
parts A and B of this title shall include benefits for individuals who 
have been determined to have end stage renal disease as provided in 
Section 226A''. The End Stage Renal Disease (ESRD) Medical Evidence 
(CMS-2728) is completed for all ESRD patients either by the first 
treatment facility or by a Medicare-approved ESRD facility when it is 
determined by a physician that the patient's condition has reached that 
stage of renal impairment that a regular course of kidney dialysis or a 
kidney transplant is necessary to maintain life.
    The data reported on the CMS-2728 is used by the Federal 
Government, ESRD Networks, treatment facilities, researchers and others 
to monitor and assess the quality and type of care provided to end 
stage renal disease beneficiaries. The data collection captures the 
specific medical information required to determine the Medicare medical 
eligibility of End Stage Renal Disease claimants. It also collects data 
for research and policy on this population.
    The three main data systems available for evaluating the ESRD 
program and for monitoring epidemiology, access, and quality and 
reimbursement effects on quality are: (1) The United States Renal Data 
System (USRDS) provides basic data on patterns of incidence of ESRD in 
the United States. The USRDS database is intended to be used for 
biomedical research by investigators throughout the United States and 
abroad. The USRDS data is intended to supplement (and not replace) 
public use files produced by CMS. (2) United Network for Organ Sharing 
(UNOS) focus is on organ donation, transplantation and educational 
activities. (3) The ESRD Program Management and Medical System (PMMIS), 
maintained by CMS, provide the foundation data for the USRDS. This 
system, as required by Public Law 95-292, section C(1)(A), is designed 
to serve the needs of the Department of Health and Human Services in 
support of program analysis, policy development, and epidemiological 
research.
    The ESRD PMMIS includes information on both Medicare and non-
Medicare ESRD patients and on Medicare approved ESRD hospitals and 
dialysis facilities. The methods of ESRD data collection (e.g., use of 
same forms, sharing of analysis) by CMS, UNOS, and USRDS have all 
agreed on a common data collection process that will provide needed 
additional information on the ESRD population.
    Subsequent to publishing the 60-day Federal Register notice on 
December 15, 2022 (87 FR 76625), questions were added to the form and 
other were clarified. Form Number: CMS-2728 (OMB control number: 0938-
0046); Frequency: Yearly; Affected Public: Private Sector (Business or 
other for-profits, Not-for-Profit Institutions); Number of Respondents: 
7,828; Total Annual Responses: 138,000; Total Annual Hours: 138,000. 
(For policy questions regarding this collection contact Lisa Rees at 
(816) 426-6353).

    Dated: May 24, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-11403 Filed 5-26-23; 8:45 am]
BILLING CODE 4120-01-P