I 
117TH CONGRESS 
2D SESSION 
H. R. 7051 
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 HOUSE OF REPRESENTATIVES 
MARCH 9, 2022 
Mr. THOMPSON of California (for himself and Mr. MCKINLEY) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend titles XVIII and XIX of the Social Security Act 
to provide for coverage of prescription digital thera-
peutics under such titles, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
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SEC. 2. COVERAGE AND PAYMENT OF PRESCRIPTION DIG-
ITAL THERAPEUTICS UNDER THE MEDICARE 
PROGRAM. 
(a) PRESCRIPTION
DIGITAL
THERAPEUTIC
DE-
FINED.—Section 1861 of the Social Security Act (42 
U.S.C. 1395x) is amended by adding at the end the fol-
lowing 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 med-
ical disease, condition, or disorder; 
‘‘(3) primarily uses software to achieve its in-
tended 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— 
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(1) in subparagraph (GG), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (HH), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(II) prescription digital therapeutics fur-
nished 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 in-
serting 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 manufac-
turers of prescription digital therapeutics, which 
may consist of a one-time payment or periodic pay-
ments, as determined appropriate by the Secretary. 
‘‘(2) CONSIDERATIONS FOR PAYMENT METHOD-
OLOGY.—For purposes of establishing the payment 
methodology under paragraph (1), the Secretary 
shall consider— 
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