Title: Access to Prescription Digital Therapeutics Act of 2022
Policy area: Health

Summary:
Access to Prescription Digital Therapeutics Act of 2022
This bill provides for Medicare and Medicaid coverage of prescription digital therapeutics (i.e., software applications that are used to prevent, manage, or treat medical conditions). The Centers for Medicare & Medicaid Services must establish a Medicare payment methodology for payments to manufacturers that takes into account certain factors (e.g., ongoing use); manufacturers must report specified information about private payors, subject to civil penalties.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3791 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 3791

To amend titles XVIII and XIX of the Social Security Act to provide for 
 coverage of prescription digital therapeutics under such titles, and 
                          for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

               March 10 (legislative day, March 7), 2022

  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 for 
 coverage of prescription digital therapeutics under such titles, 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 ``Access to Prescription Digital 
Therapeutics Act of 2022''.

SEC. 2. COVERAGE AND PAYMENT OF PRESCRIPTION DIGITAL THERAPEUTICS UNDER 
              THE MEDICARE PROGRAM.

    (a) Prescription Digital Therapeutic Defined.--Section 1861 of the 
Social Security Act (42 U.S.C. 1395x) is amended by adding at the end 
the following new subsection:
    ``(lll) Prescription Digital Therapeutic.--The term `prescription 
digital therapeutic' means a product, device, internet application, or 
other technology that--
            ``(1) is cleared or approved under section 510(k), 
        513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act;
            ``(2) has a cleared or approved indication for the 
        prevention, management, or treatment of a medical disease, 
        condition, or disorder;
            ``(3) primarily uses software to achieve its intended 
        result; and
            ``(4) is a device that is exempt from section 502(f)(1) of 
        the Federal Food, Drug, and Cosmetic Act under section 801.109 
        of title 21 of the Code of Federal Regulations (or any 
        successor regulation).''.
    (b) 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 furnished on or 
        after January 1, 2023;''.
    (c) Requirements for Prescription Digital Therapeutics Under 
Medicare.--Part B of the Social Security Act (42 U.S.C. 1395j et seq.) 
is amended by inserting after section 1834A the following new section:

``SEC. 1834B. REQUIREMENTS FOR PRESCRIPTION DIGITAL THERAPEUTICS.

    ``(a) Payment.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall establish a 
        payment methodology for manufacturers of prescription digital 
        therapeutics, which may consist of a one-time payment or 
        periodic payments, as determined appropriate by the Secretary.
            ``(2) Considerations for payment methodology.--For purposes 
        of establishing the payment methodology under paragraph (1), 
        the Secretary shall consider--
                    ``(A) the actual list charge of such prescription 
                digital therapeutic;
                    ``(B) the weighted median (calculated by arraying 
                the distribution of all payment rates reported for the 
                most recent period for which such rates were reported 
                under subsection (c)(1) for each prescription digital 
                therapeutic weighted by volume for each payor and each 
                manufacturer) for such prescription digital 
                therapeutic;
                    ``(C) in the case of a prescription digital 
                therapeutic that requires ongoing use, the amount for 
                such ongoing use; and
                    ``(D) other factors as determined by the Secretary.
    ``(b) Coding.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of this section, the Secretary shall establish 
        product-specific HCPCS codes for prescription digital 
        therapeutic covered under this title.
            ``(2) Temporary code.--The Secretary shall adopt temporary 
        product-specific HCPCS codes for purposes of providing payment 
        under this title until a permanent product-specific HCPCS code 
        has been established under paragraph (1).
    ``(c) Manufacturer Reporting.--
            ``(1) In general.--Beginning on January 1, 2023, each 
        manufacturer of a prescription digital therapeutic covered 
        under this title shall submit to the Secretary, at such time 
        and in such manner as specified by the Secretary, and annually 
        thereafter, a report describing--
                    ``(A) the payment rate that was paid by each 
                private payor for each prescription digital therapeutic 
                during the period specified by the Secretary;
                    ``(B) the volume of such prescription digital 
                therapeutic distributed to each such payor for such 
                period; and
                    ``(C) the number of individual users of such 
                prescription digital therapeutic for such period.
            ``(2) Treatment of discounts.--The payment rate reported by 
        a manufacturer in accordance with paragraph (1)(A) shall 
        reflect all discounts, rebates, coupons, and other price 
        concessions, including those described in section 1847A(c)(3).
            ``(3) Civil monetary penalty.--
                    ``(A) In general.--If the Secretary determines that 
                a manufacturer has failed to report, or made a 
                misrepresentation or omission in reporting, information 
                under this subsection with respect to a prescription 
                digital therapeutic, the Secretary may apply a civil 
                money penalty in an amount of up to $10,000 per day for 
                each failure to report or each such misrepresentation 
                or omission.
                    ``(B) Application.--The provisions of section 1128A 
                (other than subsections (a) and (b)) shall apply to a 
                civil money penalty under this paragraph in the same 
                manner as they apply to a civil money penalty or 
                proceeding under section 1128A(a).
            ``(4) Confidentiality.--Information reported under this 
        subsection shall be treated in the same manner in which 
        information disclosed by a manufacturer or a wholesaler of a 
        covered outpatient drug is treated under section 1927(b)(3)(D).
    ``(d) Definitions.--For purposes of this section:
            ``(1) Actual list charge.--The term `actual list charge' 
        means the publicly available payment rate for a prescription 
        digital therapeutic on the first day that such prescription 
        digital therapeutic is available for purchase by a private 
        payor.
            ``(2) HCPCS.--The term `HCPCS' means, with respect to an 
        item, the code under the Healthcare Common Procedure Coding 
        System (HCPCS) (or a successor code) for such item.
            ``(3) Manufacturer.--The term `manufacturer' has the 
        meaning given such term by section 820.3(o) of title 21, Code 
        of Federal Regulations (or any successor regulation).
            ``(4) Prescription digital therapeutic.--The term 
        `prescription digital therapeutic' has the meaning given such 
        term in section 1861(lll).
            ``(5) Private payor.--The term `private payor' has the 
        meaning given such term in section 1834A(a)(8).''.

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 (30), by striking ``; and'' and inserting 
        a semicolon;
            (2) by redesignating paragraph (31) as paragraph (32); and
            (3) by inserting the following paragraph after paragraph 
        (30):
            ``(31) prescription digital therapeutics (as defined in 
        section 1861(lll)); and''.
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