II 116th CONGRESS 2d Session S. 3532 IN THE SENATE OF THE UNITED STATES March 18, 2020 Mrs. Capito (for herself and Mrs. Shaheen ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend titles XVIII and XIX of the Social Security Act to provide coverage of prescription digital therapeutics for the treatment of mental health and substance use disorders under the Medicare and Medicaid programs, and for other purposes.

1. Short title This Act may be cited as the Prescription Digital Therapeutics to Support Recovery Act . 2. Coverage of prescription digital therapeutics under the Medicare program (a) Coverage as medical and other health service Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (1) in subparagraph (GG), by striking and at the end; (2) in subparagraph (HH), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new subparagraph: (II) prescription digital therapeutics as defined in subsection (kkk). . (b) Prescription digital therapeutics defined Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended by adding at the end thereof the following new subsection: (kkk) Prescription Digital Therapeutics defined (1) In general The term prescription digital therapeutic means a product, device, internet application, or other technology that— (A) is approved or cleared by the Food and Drug Administration under a relevant authority (within the meaning of paragraph (2)); (B) has an approved indication for the prevention, management, or treatment of a mental health or substance use disorder, including opioid use disorder; (C) uses behavioral treatment or modification to achieve its intended result; and (D) can only be dispensed pursuant to a prescription. (2) Relevant authority defined For purposes of paragraph (1), the term relevant authority means the following sections of the Federal Food, Drug, and Cosmetic Act: (A) Section 510(k) of such Act ( 21 U.S.C. 360(k) ). (B) Section 515 of such Act ( 21 U.S.C. 360e ). . (c) Payment for prescription digital therapeutics Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (x) Payment for prescription digital therapeutics (1) Separate payment The Secretary shall make a payment (separate from any payment that may otherwise be made under this title for a related service) in the amount established pursuant to paragraph (3) for a prescription digital therapeutic (as defined in section 1861(kkk)) that is furnished on or after January 1, 2021. (2) Payment recipient Payment under this subsection shall be made to any provider of services or supplier enrolled under this title that— (A) prescribes a prescription digital therapeutic (as defined in such subsection); (B) uses such prescription digital therapeutic as an integral part of a treatment for a related service; and (C) agrees to accept, as payment in full, after the application of any deductible or coinsurance that may be applied under this part, the amount established pursuant to paragraph (3). (3) Establishment of payment amount (A) In general The Secretary shall establish a payment methodology for a prescription digital therapeutic only in accordance with the requirements of this paragraph. (B) Development of fee schedule Within 180 days of the approval or clearance described in section 1861(kkk)(1)(A), the Secretary shall develop a proposed fee schedule for each prescription digital therapeutic so approved or cleared. In developing such fee schedule, the Secretary may use the gap filling process described on 84 Federal Register 60729 through 60742 and published on November 8, 2019. (C) Notice and comment required Upon the development of the proposed fee schedule described in subparagraph (B), the Secretary shall publish in the Federal Register such proposed fee schedule. Section 1871 shall apply to any proposed fee scheduled published pursuant to this subparagraph. (4) Rule of construction For purposes of paragraph (1), a service is related to the use of a prescription digital therapeutic if the service— (A) is an integral part of the use of the prescription digital therapeutic; (B) is necessary to achieve the full intended result of the prescription digital therapeutic; and (C) must, pursuant to the approval or clearance described in section 1861(kkk)(1)(A), be adjunctive to the use of the prescription digital therapeutic. . (d) Rule of construction; effective date (1) Rule of construction No provision of this section, or the enactment of this section, shall be construed to imply that, in the case of an item or service that meets the definition of a prescription digital therapeutic under this section for which coverage or payment under the Medicare program is already available prior to the date of the enactment of this Act may not be covered or reimbursed under such program. (2) Effective date The amendments made by this section shall apply to a prescription digital therapeutic dispensed after December 31, 2020. 3. Coverage of prescription digital therapeutics under the Medicaid program Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (1) in paragraph (29), by striking ; and and inserting a semicolon; (2) by redesignating paragraph (30) as paragraph (31); and (3) by inserting the following paragraph after paragraph (29): (30) prescription digital therapeutics (as defined in section 1861(kkk)); and .