119-hr3288

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3288 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 3288

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

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 May 8, 2025

 Mr. Hern of Oklahoma (for himself and Mr. Thompson of California) 
 introduced the following bill; which was referred to the Committee on 
 Energy and Commerce, and in addition to the Committee on Ways and 
 Means, for a period to be subsequently determined by the Speaker, in 
 each case for consideration of such provisions as fall within the 
 jurisdiction of the committee concerned

_______________________________________________________________________

 A BILL

To amend titles XVIII and XIX of the Social Security Act to provide for 
 coverage of prescription digital therapeutics 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 ``Access to Prescription Digital 
Therapeutics Act of 2025''.

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:
 ``

    (nnn) 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

    (JJ) , by adding ``and'' at the end; and

    (2) by adding at the end the following new subparagraph:
 ``

    (KK) prescription digital therapeutics (as defined in 
 subsection

    (nnn) ) furnished on or after January 1, 2026;''.
            (c) Requirements for Prescription Digital Therapeutics Under 
Medicare.--Part B of title XVIII 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 
 the 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 
 the 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.--Not later than January 1, 2026, and not 
 less frequently than annually thereafter, 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, a report describing--
 ``
        (A) the payment rate that was paid by each 
 private payor for such 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 under 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 in 

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

    (nnn) .
 ``

    (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

    (31) , by striking ``; and'' and inserting 
 a semicolon;

    (2) by redesignating paragraph

    (32) as paragraph

    (33) ; and

    (3) by inserting after paragraph

    (31) the following new 
 paragraph:
 ``

    (32) prescription digital therapeutics (as defined in 
 

section 1861

    (nnn) ); and''.
 <all>