[Page S4872]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2561. Mrs. CAPITO submitted an amendment intended to be proposed 
to amendment SA 2499 proposed by Mr. McConnell to the bill S. 178, to 
condemn gross human rights violations of ethnic Turkic Muslims in 
Xinjiang, and calling for an end to arbitrary detention, torture, and 
harassment of these communities inside and outside China; which was 
ordered to lie on the table; as follows:

        At the appropriate place, insert the following:

     SEC. __. 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.

     SEC. __. 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''.
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