S4094-118

1. Short title This Act may be cited as the Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies Act or the PREVENT DIABETES Act.

2. Medicare Diabetes Prevention Program Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended— in subsection (s)(2), by adding at the end the following new subparagraph: diabetes prevention program services (as defined in subsection (nnn)); by adding at the end the following new subsection: The term diabetes prevention program services means structured behavioral health change sessions that— are furnished to an eligible individual described in paragraph (2) by a diabetes prevention program supplier for the purpose of preventing or delaying the onset of type II diabetes; follow a CDC-approved curriculum; and are furnished on or after January 1, 2025. An eligible individual described in this paragraph is an individual that— is entitled to benefits under part A and is enrolled under part B; has no previous diagnosis of diabetes (other than gestational diabetes); does not have end-stage renal disease; and meets additional medical criteria specified by the Secretary. There shall be no limitation on the number of times an eligible individual may enroll in the diabetes prevention program. Section 1862(a)(1) of the Social Security Act (42 U.S.C. 1395y(a)(1)) is amended— in subparagraph (O), by striking and at the end; in subparagraph (P), by striking the semicolon at the end and inserting , and; and by adding at the end the following new subparagraph: in the case of diabetes prevention program services (as defined in section 1861(nnn)(1)), which are furnished to an individual who is not an eligible individual (as defined in section 1861(nnn)(2)); Section 1866 of the Social Security Act (42 U.S.C. 1395cc) is amended by adding at the end the following new subsection: In this subsection, the term diabetes prevention program supplier means an entity that— is recognized under the Centers for Disease Control and Prevention Diabetes Prevention Recognition Program and offers a program through an allowable Diabetes Prevention Recognition Program delivery mode including in-person, online, distance learning, combination, and other synchronous and asynchronous modalities as determined by the Secretary; is enrolled under the diabetes prevention program in accordance with paragraph (2); and meets the requirements described in paragraph (2)(B). An entity seeking to enroll as a diabetes prevention program supplier under this section shall submit to the Secretary an application for enrollment at such time and in such manner as specified by the Secretary. Such application must meet all elements as specified by the Secretary. Each diabetes prevention program supplier shall maintain— administrative requirements as outlined by the Secretary; active enrollment as a diabetes prevention program supplier under subsection (j); and at least one administrative location. Each diabetes prevention program supplier shall maintain documentation in accordance with standards specified by the Secretary. Each diabetes prevention program supplier shall maintain information as specified by the Secretary and submit it to the Secretary in the form and manner specified by the Secretary. Each diabetes prevention program supplier shall allow the Secretary, or any person or organization designated by the Secretary, to conduct inspections of any administrative location of a diabetes prevention program supplier, or of any eligible setting in which diabetes prevention program services are furnished, as well as review all documentation and records maintained by such supplier for purposes of the diabetes prevention program. The Secretary may terminate the enrollment of a diabetes prevention program supplier for purposes of participation in the diabetes prevention program if such supplier— fails to meet the requirements described in subparagraph (B); improperly denies services to an eligible individual (as defined in section 1861(nnn)(2)), including a denial on the basis of an eligible individual’s weight, health status, or achievement of performance goals; or fails to comply with additional standards established by the Secretary. In this subsection, the term administrative location means a physical location in which a diabetes prevention program supplier is the primary operator of such location or the location from which the diabetes prevention program supplier’s business is run in the case of an online or combination program, and where in-person diabetes prevention program services may or may not be furnished. Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended— by striking and (HH) and inserting (HH); and in subparagraph (HH), by striking the semicolon at the end and inserting the following: , and (II) with respect to diabetes prevention program services furnished on or after January 1, 2025, as described in section 1861(nnn), the amount paid shall be equal to 100 percent of the payment amount established in the payment structure described in section 1834(aa);. Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following subsection: The Secretary shall establish an appropriate payment structure under which the Secretary shall make payments to a diabetes prevention program supplier for diabetes prevention program services furnished to an eligible individual (as defined in section 1861(nnn)(2)). The Secretary shall update the payment structure under this subsection annually by the percentage increase in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the preceding year. A diabetes prevention program supplier may terminate the participation of an individual participating in the diabetes prevention program if the individual is no longer an eligible individual (as defined in section 1862(nnn)(2)). In the case of a diabetes prevention program supplier that terminates the participation of an individual participating in the diabetes prevention program, such supplier shall maintain records supporting such termination, including the date of the termination, the reason for the termination, the details of any incidents leading to such termination, any remediation efforts taken by such supplier, and any final actions taken by such supplier. Except as specified otherwise in this Act, the Secretary shall extend the standards of the Medicare Diabetes Prevention Program Expanded Model (in effect as of the date of enactment of the PREVENT DIABETES Act) to govern the diabetes prevention program. In this subsection, the term diabetes prevention program means the payment structure described in this subsection. (KK)diabetes prevention program services (as defined in subsection (nnn));; and (nnn)Diabetes prevention program services(1)In generalThe term diabetes prevention program services means structured behavioral health change sessions that—(A)are furnished to an eligible individual described in paragraph (2) by a diabetes prevention program supplier for the purpose of preventing or delaying the onset of type II diabetes;(B)follow a CDC-approved curriculum; and(C)are furnished on or after January 1, 2025.(2)Eligible individual describedAn eligible individual described in this paragraph is an individual that—(A)is entitled to benefits under part A and is enrolled under part B;(B)has no previous diagnosis of diabetes (other than gestational diabetes);(C)does not have end-stage renal disease; and(D)meets additional medical criteria specified by the Secretary.(3)No lifetime limit on participationThere shall be no limitation on the number of times an eligible individual may enroll in the diabetes prevention program.. (Q)in the case of diabetes prevention program services (as defined in section 1861(nnn)(1)), which are furnished to an individual who is not an eligible individual (as defined in section 1861(nnn)(2));. (l)Diabetes prevention program suppliers(1)Diabetes prevention program supplierIn this subsection, the term diabetes prevention program supplier means an entity that—(A)is recognized under the Centers for Disease Control and Prevention Diabetes Prevention Recognition Program and offers a program through an allowable Diabetes Prevention Recognition Program delivery mode including in-person, online, distance learning, combination, and other synchronous and asynchronous modalities as determined by the Secretary;(B)is enrolled under the diabetes prevention program in accordance with paragraph (2); and(C)meets the requirements described in paragraph (2)(B).(2)Enrollment in diabetes prevention program(A)ApplicationAn entity seeking to enroll as a diabetes prevention program supplier under this section shall submit to the Secretary an application for enrollment at such time and in such manner as specified by the Secretary. Such application must meet all elements as specified by the Secretary.(B)Requirements(i)Administrative requirementsEach diabetes prevention program supplier shall maintain—(I)administrative requirements as outlined by the Secretary;(II)active enrollment as a diabetes prevention program supplier under subsection (j); and(III)at least one administrative location.(ii)Documentation; data submission(I)DocumentationEach diabetes prevention program supplier shall maintain documentation in accordance with standards specified by the Secretary.(II)Data submissionEach diabetes prevention program supplier shall maintain information as specified by the Secretary and submit it to the Secretary in the form and manner specified by the Secretary.(iii)Inspection and review requirementsEach diabetes prevention program supplier shall allow the Secretary, or any person or organization designated by the Secretary, to conduct inspections of any administrative location of a diabetes prevention program supplier, or of any eligible setting in which diabetes prevention program services are furnished, as well as review all documentation and records maintained by such supplier for purposes of the diabetes prevention program.(C)Diabetes prevention program supplier terminationThe Secretary may terminate the enrollment of a diabetes prevention program supplier for purposes of participation in the diabetes prevention program if such supplier—(i)fails to meet the requirements described in subparagraph (B);(ii)improperly denies services to an eligible individual (as defined in section 1861(nnn)(2)), including a denial on the basis of an eligible individual’s weight, health status, or achievement of performance goals; or(iii)fails to comply with additional standards established by the Secretary.(3)Administrative location definedIn this subsection, the term administrative location means a physical location in which a diabetes prevention program supplier is the primary operator of such location or the location from which the diabetes prevention program supplier’s business is run in the case of an online or combination program, and where in-person diabetes prevention program services may or may not be furnished.. (aa)Payment for diabetes prevention program services(1)In generalThe Secretary shall establish an appropriate payment structure under which the Secretary shall make payments to a diabetes prevention program supplier for diabetes prevention program services furnished to an eligible individual (as defined in section 1861(nnn)(2)).(2)Annual updateThe Secretary shall update the payment structure under this subsection annually by the percentage increase in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the preceding year.(3)Termination of participation(A)In generalA diabetes prevention program supplier may terminate the participation of an individual participating in the diabetes prevention program if the individual is no longer an eligible individual (as defined in section 1862(nnn)(2)).(B)Documentation supporting terminationIn the case of a diabetes prevention program supplier that terminates the participation of an individual participating in the diabetes prevention program, such supplier shall maintain records supporting such termination, including the date of the termination, the reason for the termination, the details of any incidents leading to such termination, any remediation efforts taken by such supplier, and any final actions taken by such supplier.(4)Continuation of medicare diabetes prevention program expanded model standardsExcept as specified otherwise in this Act, the Secretary shall extend the standards of the Medicare Diabetes Prevention Program Expanded Model (in effect as of the date of enactment of the PREVENT DIABETES Act) to govern the diabetes prevention program.(5)Diabetes prevention programIn this subsection, the term diabetes prevention program means the payment structure described in this subsection..

3. Sunset of MDPP Expanded Model No payment shall be made for services furnished under the Medicare Diabetes Prevention Program Expanded Model conducted under section 1115A of the Social Security Act (42 U.S.C. 1315a) after January 1, 2025.

4. Update to regulations Not later than November 30, 2024, the Secretary of Health and Human Services shall update the regulations in sections 410.79, 414.84, 424.200, and 424.205 of title 42, Code of Federal Regulations, and any other relevant regulations, in accordance with sections 2 and 3 of this Act.

5. Report Not later than January 1, 2028, the Secretary of Health and Human Services shall submit to Congress a report on the diabetes prevention program. Such report shall include a description of the impact of such program on— participation of eligible individuals and diabetes prevention program suppliers in the diabetes prevention program as compared to the Medicare Diabetes Prevention Program Expanded Model; weight loss among eligible individuals; health outcomes of eligible individuals; and diagnoses and costs relating to type 2 diabetes for eligible individuals who have received diabetes prevention plan services versus those who have not.