I 
118TH CONGRESS 
1ST SESSION H. R. 1458 
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 8, 2023 
Mr. HERN (for himself, Mr. THOMPSON of California, Mr. JOHNSON of Ohio, 
and Ms. MATSUI) 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 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 2023’’. 
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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: 
‘‘(nnn) PRESCRIPTION DIGITAL THERAPEUTIC.— 
The term ‘prescription digital therapeutic’ means a prod-
uct, 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 (HH), by striking ‘‘and’’ 
at the end; 
(2) in subparagraph (II), by striking the period 
at the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(JJ) prescription digital therapeutics (as 
defined in subsection (nnn)) furnished on or 
after January 1, 2024;’’. 
(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 
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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, 
2024, 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 dig-
ital 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 pay-
ment rate reported by a manufacturer in accordance 
with paragraph (1)(A) shall reflect all discounts, re-
bates, coupons, and other price concessions, includ-
ing those described in section 1847A(c)(3). 
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‘‘(3) CIVIL MONETARY PENALTY.— 
‘‘(A) IN GENERAL.—If the Secretary deter-
mines that a manufacturer has failed to report, 
or made a misrepresentation or omission in re-
porting, 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 fail-
ure 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 is disclosed by a manu-
facturer or a wholesaler of a covered outpatient 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 
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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 ‘manufac-
turer’ 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(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 THERA-
PEUTICS 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 para-
graph (32); and 
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(3) by inserting the following paragraph after 
paragraph (30): 
‘‘(31) prescription digital therapeutics (as de-
fined in section 1861(nnn)); and’’. 
Æ 
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