[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3532 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 3532

  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.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prescription Digital Therapeutics to 
Support Recovery Act''.

SEC. 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.

SEC. 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''.
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