[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.
[[Page 34503]]
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