On December 1 2020, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2021 Physician Fee Schedule (PFS) final rule, which revises certain MDPP policies during the remainder of the COVID-19 Public Health Emergency (PHE) and any future applicable 1135 waiver event.
We will determine whether an 1135 waiver event could disrupt in-person MDPP services based on whether MDPP suppliers are unable to conduct in-person classes or MDPP beneficiaries are unable to attend in-person classes, for reasons related to health, safety, or site availability or suitability. Health and safety reasons may include avoiding the transmission of contagious diseases, compliance with laws and regulations during an 1135 waiver event, or the physical safety of MDPP beneficiaries or MDPP coaches during an 1135 waiver event. If we determine that an 1135 waiver event may disrupt in-person services, we will notify all impacted MDPP suppliers of the applicable 1135 waiver event via email and other means as appropriate.
MDPP Once Per Lifetime Set of Services
We are also finalizing a revision to the March 31, 2020 COVID-19 IFC in which we temporarily permitted certain beneficiaries to obtain the set of MDPP services more than once per lifetime, waive the 5 percent weight loss eligibility requirements, and allow certain MDPP suppliers to either pause the delivery of MDPP services or deliver virtual MDPP sessions on a temporary basis. In this final rule, we established an Emergency Policy that applies more broadly, improves the current flexibilities for the COVID-19 PHE, and provides MDPP suppliers and MDPP beneficiaries with flexibilities to address any future applicable 1135 waiver event. The flexibilities apply effective January 1, 2021 to the remainder of the COVID-19 PHE and all future applicable 1135 waiver events.
We have also amended the MDPP regulations to provide for certain flexibilities during an applicable 1135 waiver event, including:
- Allowing MDPP suppliers to either deliver MDPP services virtually or suspend in-person MDPP services and resume MDPP services at a later date.
- Allowing MDPP beneficiaries who begin the set of MDPP services virtually, or who change from in-person MDPP services to virtual during the PHE for COVID-19 or an applicable 1135 waiver event, to continue the MDPP set of services virtually, even after the PHE or 1135 waiver event has concluded.
- Permitting certain MDPP beneficiaries to obtain the set of MDPP services more than once per lifetime. We will allow a suspension in service due to an applicable 1135 waiver event and we will provide flexibilities that allow MDPP beneficiaries to maintain eligibility for MDPP services despite a break in service.
- Adding virtual weight measurement methods and allowing MDPP beneficiaries to self-report their weights by submitting a time and date-stamped photo or video of their home scale with their current weight measurement. In addition, MDPP beneficiary can use online video technology such as video chatting or video conferencing with an MDPP coach.
- Extending the flexibilities finalized in the March 31st COVID-19 IFC to all beneficiaries who were receiving MDPP services as of March 31, 2020, instead of March 1, 2020.
Virtual Make-up and Regular Sessions
We have finalized that the limit placed on the number of virtual make-up sessions described at § 410.79 will not apply during the remainder of the COVID-19 PHE, or during any future applicable 1135 waiver event for MDPP suppliers to provide MDPP services virtually, so long as the virtual services are furnished in a manner that is consistent with the CDC Diabetes Prevention Recognition Program standards for virtual sessions, follow the CDC-approved DPP curriculum requirements, and the supplier has an in-person DPRP organizational code. We amended the regulations to clarify that all sessions, including the first core session, may be offered virtually, not as “virtual make-up sessions,” but as a virtual class consistent with the in-person class curriculum, during the remainder of the COVID-19 PHE and any future applicable 1135 waiver event. We also finalized that MDPP beneficiaries will be allowed to continue the MDPP set of services virtually, even after the COVID-19 PHE or applicable 1135 waiver event has concluded.
The MDPP expanded model was originally intended to provide primarily in-person MDPP services and does not include a “virtual only” option. Virtual delivery of MDPP services are allowable during the COVID-19 PHE and future applicable 1135 waiver events to ensure continuity of services when in-person classes are not safe or feasible. We do not believe it is appropriate to permit virtual-only MDPP suppliers to furnish MDPP services when the Emergency Policy is in effect. Given the difficulty of predicting when the COVID-19 PHE or any applicable 1135 waiver event will end, MDPP suppliers must remain prepared to resume delivery of MDPP services in-person when the Emergency Policy is no longer in effect. Permitting virtual-only MDPP suppliers to furnish MDPP services during the COVID-19 PHE or an applicable 1135 waiver event could disrupt the provision of services to MDPP beneficiaries who want to return to in-person services when MDPP services resume on an in-person basis.
We finalized the provision that these virtual sessions may be furnished to achieve both attendance and weight-loss goals in the event that a qualifying weight measurement was obtained by one of the methods described in the rule. We also finalized that an MDPP supplier may offer to an MDPP beneficiary: 16 virtual sessions offered weekly during the core session period; 6 virtual sessions offered monthly during the core maintenance session interval periods; and 12 virtual sessions offered monthly during the ongoing maintenance session interval periods. MDPP suppliers may only furnish a maximum of one regularly scheduled session virtually and a maximum of one virtual make-up session per week to an MDPP beneficiary. This rule increases the number of allowable virtual core sessions from 15 to 16. This change is due to the added flexibility to allow MDPP suppliers to obtain weight measurements remotely (as described below) and to deliver the first core session virtually.
Under these temporary flexibilities, the requirement for in-person attendance at the first core-session does not apply. During the remainder of the COVID-19 PHE and any future applicable 1135 waiver event, MDPP suppliers may obtain weight measurements from MDPP beneficiaries through the following methods: (1) in-person, when the weight measurement can be obtained safely and in compliance with any and all applicable laws and regulations; (2) via digital technology, such as scales that transmit weights securely via wireless or cellular transmission (commonly referred to as “Bluetooth™ enabled”); or (3) self-reported weight measurements from a MDPP beneficiary’s own at-home digital scale. Self-reported weights must be submitted via video or photo by the MDPP beneficiary to the MDPP supplier. The video or photo must clearly document the weight of the MDPP beneficiary as it appears on his/her digital scale on the date associated with the billable MDPP session. Weight measurements can also be obtained by using synchronous, online video technology such as video chatting or video conferencing with an MDPP coach, where the coach can clearly observe the self-recorded weight of the MDPP beneficiary.
Weight Loss Requirements and Eligibility for Ongoing Maintenance Sessions
Because of the temporary flexibilities for weight loss measurements described above, we have finalized that the waiver of the minimum weight loss requirements for beneficiary eligibility in the ongoing maintenance session intervals described in § 410.14(g)(3)(iv) of the March 31, 2020 COVID-19 IFC (85 FR 19230) be ended prospectively. Effective January 1, 2021, the 5 percent weight loss eligibility waiver described in § 410.14(g)(3)(iv) will end for MDPP beneficiaries starting after this date. However, the 5 percent weight loss eligibility waiver will remain in effect for MDPP beneficiaries who were receiving the set of MDPP services prior to January 1, 2021. MDPP beneficiaries who were receiving MDPP services prior to January 1, 2021 are not required to meet or maintain a 5 percent weight loss to maintain eligibility for the ongoing maintenance year and may resume or restart services without meeting the 5 percent weight loss requirement. However, MDPP beneficiaries who start the set of MDPP services on or after January 1, 2021 will be required to meet and maintain the 5 percent weight loss goal to be eligible for the ongoing maintenance year described in § 410.79 (c)(1)(ii)(B) and (iii)(B).
Beneficiary Engagement Incentives
The disruption to MDPP services caused by an applicable 1135 waiver event may cause an MDPP supplier not to have contact with an MDPP beneficiary for more than 90 consecutive calendar days. We are proposed amendments to the definition of “engagement incentive period” to further qualify when the period ends in the case of the COVID-19 PHE or an applicable 1135 waiver event. After further consideration, we are not finalizing the proposed changes to paragraph (iii) of the definition of engagement incentive period. That provision will continue to specify that the engagement incentive period will end if the MDPP supplier has not had direct contact with the MDPP beneficiary, whether in person, by telephone, or via other telecommunications technology, for more than 90 consecutive calendar days during the MDPP services period. Under this provision, the engagement incentive period will not end with respect to an MDPP beneficiary who begins to receive MDPP services virtually within 90 days after the occurrence of an 1135 waiver event that CMS determines is likely to disrupt the furnishing of in-person MDPP services.
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