[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Rules and Regulations]
[Pages 27413-27414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 410

[CMS-5539-N]
RIN 0938-


Medicare Program; Extending the Medicare Diabetes Prevention 
Program's (MDPP) Expanded Model Emergency Policy Through CY 2023

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Policy extension.

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SUMMARY: This document is to alert Medicare Diabetes Prevention Program 
(MDPP) expanded model suppliers and interested parties that although 
current MDPP flexibilities permitted pursuant to regulations issued 
during the Public Health Emergency (PHE) for COVID-19 are scheduled to 
expire on May 11, 2023, we are specifying an effective date, for 
purposes of the regulations of December 31, 2023, through which in-
person delivery of MDPP services can be suspended. This extended 
effective date applies for all MDPP suppliers to allow additional time 
to resume in-person services. MDPP suppliers may use all of or part of 
this period to extend the flexibilities described in the regulations. 
This document provides information to MDPP suppliers regarding the 
extension of the ability to suspend in-person services as the PHE for 
COVID-19 concludes.

DATES: Effective on May 2, 2023, the PHE flexibilities described under 
42 CFR 410.79(e) are extended through 11:59 p.m. EST on December 31, 
2023.

FOR FURTHER INFORMATION CONTACT: Mollie Howerton, (410) 786-5395, and 
Karen Abraham-Burrell, (410) 786-4789.

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 28, 2020, the Centers for Medicare & Medicaid Services 
(CMS) issued the Calendar Year (CY) 2021 Physician Fee Schedule (PFS) 
final rule (85 FR 84472), which modified certain Medicare Diabetes 
Prevention Program (MDPP) policies for the remainder of the COVID-19 
Public Health Emergency (PHE), as well as during any future 1135 waiver 
event that we determine may disrupt in-person MDPP services (an 
``applicable 1135 waiver event''). Accordingly, under the amended 
regulation at 42 CFR 410.79(e)(3)(v), MDPP suppliers have been 
permitted to suspend in-person delivery of the set of MDPP services 
during the PHE and are required to resume in-person services either 
upon the end of the PHE or upon an effective date specified by CMS. The 
term ``set of MDPP services'' is defined at Sec.  410.79(b) to mean the 
series of MDPP sessions, composed of core sessions and core maintenance 
sessions offered over the course of the MDPP services period. Under 
Sec.  410.79(c)(iv), weight measurements used to determine the 
achievement or maintenance of the required minimum weight loss must be 
taken during an ``MDPP session,'' which is defined at Sec.  410.79(b) 
to mean a core session or a core maintenance session.
    The MDPP regulations provide for the following flexibilities during 
the PHE or an applicable 1135 waiver event:
     Alternatives to the requirement for in-person weight 
measurement (Sec.  410.79(e)(3)(iii)). Section 410.79(e)(3)(iii) 
permits an MDPP supplier to obtain weight measurements for MDPP 
beneficiaries for the baseline weight and any weight loss-based 
performance achievement goals in the following manner: (1) via digital 
technology, such as scales that transmit weights securely via wireless 
or cellular transmission; or (2) via self-reported weight measurements 
from the at-home digital scale of the MDPP beneficiary. We stated that 
self-reported weights must be obtained during live, synchronous online 
video technology, such as video chatting or video conferencing, wherein 
the MDPP coach observes the beneficiary weighing themselves and views 
the weight indicated on the at-home digital scale. Alternatively, the 
MDPP beneficiary may self-report their weight by submitting to the MDPP 
supplier a date-stamped photo or video recording of the beneficiary's 
weight, with the beneficiary visible in their home. The photo or video 
must clearly document the weight of the MDPP beneficiary as it appears 
on the digital scale on the date associated with the billable MDPP 
session. This flexibility allows suppliers to bill for participants 
achieving weight loss performance goals.
     Elimination of the maximum number of virtual services 
(Sec.  410.79(e)(3)(iv)). The virtual session limits described in Sec.  
410.79 (d)(2), and (d)(3)(i) and (ii) do not apply, and MDPP suppliers 
may provide all MDPP sessions virtually during the PHE as defined in 42 
CFR 400.200 or applicable 1135 waiver event. Under this provision, MDPP 
suppliers are permitted to provide MDPP services virtually during the 
PHE, as long as the virtual services are furnished in a manner that is 
consistent with the CDC Diabetes Prevention Recognition

[[Page 27414]]

Program (DPRP) standards for virtual sessions, the curriculum furnished 
during the virtual sessions addresses the same curriculum topics as the 
CDC-approved National Diabetes Prevention Program (National DPP) 
curriculum, the supplier has an in-person DPRP organizational code, and 
other requirements specified at Sec.  410.79(e)(3)(iv) are satisfied. 
For more information on the MDPP flexibilities allowed during the PHE, 
please see https://www.cms.gov/files/document/participants-medicare-diabetes-prevention-program-cms-flexibilities-fight-covid-19.pdf.
    For purposes of Sec.  410.79(e)(3)(v), we are specifying an 
effective date of December 31, 2023, through which MDPP suppliers may 
suspend in-person delivery of the set of MDPP services. We recognize 
that extending the suspension of in-person delivery of the set of MDPP 
services would not be useful without also extending the PHE 
flexibilities permitted under Sec.  410.79(e)(3)(iii) (regarding use of 
alternative methods for obtaining weight measurements during virtual 
services) and Sec.  410.79(e)(3)(iv) (regarding elimination of the 
maximum number of virtual services). Therefore, we are extending the 
PHE flexibilities at Sec.  410.79(e)(3)(iii), and (iv), to ensure that 
MDPP suppliers can continue delivering the set of MDPP services on a 
virtual basis, including all core and core maintenance sessions as well 
as the collection of body weight measurements.
    Given the 3-year duration of the COVID-19 PHE, we anticipate that 
MDPP suppliers will need time following the end of the COVID-19 PHE to 
resume in-person services for reasons that may include securing an 
available physical location that meets organizational and beneficiary 
needs, recruiting coaches, educating new and existing beneficiaries 
about in-person sessions, and adjusting messaging regarding the 
delivery modality of MDPP. Based on feedback from MDPP suppliers, 
interested parties, CDC DPRP and National Diabetes Prevention Program 
staff, we anticipate that MDPP suppliers may require at least 6 
additional months to adequately prepare to resume in-person services 
from an operational perspective as well as allow time for us to 
consider doing additional rulemaking. Therefore, we will allow MDPP 
suppliers to utilize the period covering May 12, 2023, through December 
31, 2023, to resume in-person services through the use of all or part 
of this period to extend the flexibilities described in Sec.  
410.79(e), to allow for an orderly transition of the flexibilities 
enabled by the PHE for COVID-19.

II. Provisions of This Document

    We established and implemented policies for MDPP in response to the 
COVID-19 PHE to support our goals of ensuring beneficiary access to 
necessary services and maintenance of these services. Although we 
previously informed MDPP suppliers and interested parties that they 
must be prepared to resume in-person services following the end of the 
PHE, MDPP suppliers may continue to utilize the MDPP flexibilities 
allowed under Sec.  410.79(e) through December 31, 2023, to maintain 
the continuity of services for both suppliers and beneficiaries as the 
public transitions out of the COVID-19 PHE. Under Sec.  
410.79(e)(3)(v), we allowed MDPP suppliers to suspend the in-person 
delivery of MDPP when necessary due to an applicable 1135 waiver event, 
and subsequently resume in-person services either upon the end date of 
the 1135 waiver event emergency period or an effective date specified 
by us. Given the 3-year duration of the PHE, we anticipate that MDPP 
suppliers will need additional time to resume in-person services due to 
reasons such as possible site inactivity, supplier inactivity, or 
challenges regarding in-person beneficiary recruitment. MDPP suppliers 
may use this period to continue the flexibilities described under Sec.  
410.79(e), in recognition of the variable effects of the PHE for COVID-
19 on both MDPP suppliers and Medicare beneficiaries.
    The Administrator of the CMS, Chiquita Brooks-LaSure, having 
reviewed and approved this document, authorizes Evell J. Barco Holland, 
who is the Federal Register Liaison, to electronically sign this 
document for purposes of publication in the Federal Register.

    Dated: April 26, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-09188 Filed 4-28-23; 4:15 pm]
BILLING CODE 4120-01-P