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 therapeutics under such titles, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Access to Prescription 

5 Digital Therapeutics Act of 2023’’. 


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1 SEC. 2. COVERAGE AND PAYMENT OF PRESCRIPTION DIG2 ITAL THERAPEUTICS UNDER THE MEDICARE 

3 PROGRAM. 

4 (a) PRESCRIPTION DIGITAL THERAPEUTIC DE5 FINED.—Section 1861 of the Social Security Act (42 

6 U.S.C. 1395x) is amended by adding at the end the fol7 lowing new subsection: 

8 ‘‘(nnn) PRESCRIPTION DIGITAL THERAPEUTIC.— 

9 The term ‘prescription digital therapeutic’ means a prod10 uct, device, internet application, or other technology 

11 that— 

12 ‘‘(1) is cleared or approved under section 

13 510(k), 513(f)(2), or 515 of the Federal Food, 

14 Drug, and Cosmetic Act; 

15 ‘‘(2) has a cleared or approved indication for 

16 the prevention, management, or treatment of a med17 ical disease, condition, or disorder; 

18 ‘‘(3) primarily uses software to achieve its in19 tended result; and 

20 ‘‘(4) is a device that is exempt from section 

21 502(f)(1) of the Federal Food, Drug, and Cosmetic 

22 Act under section 801.109 of title 21 of the Code of 

23 Federal Regulations (or any successor regulation).’’. 

24 (b) COVERAGE AS MEDICAL AND OTHER HEALTH

25 SERVICE.—Section 1861(s)(2) of the Social Security Act 

26 (42 U.S.C. 1395x(s)(2)) is amended— 


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1 (1) in subparagraph (HH), by striking ‘‘and’’ 

2 at the end; 

3 (2) in subparagraph (II), by striking the period 

4 at the end and inserting ‘‘; and’’; and 

5 (3) by adding at the end the following new sub6 paragraph: 

7 ‘‘(JJ) prescription digital therapeutics (as 

8 defined in subsection (nnn)) furnished on or 

9 after January 1, 2024;’’. 

10 (c) REQUIREMENTS FOR PRESCRIPTION DIGITAL

11 THERAPEUTICS UNDER MEDICARE.—Part B of the Social 

12 Security Act (42 U.S.C. 1395j et seq.) is amended by in13 serting after section 1834A the following new section: 

14 ‘‘SEC. 1834B. REQUIREMENTS FOR PRESCRIPTION DIGITAL 

15 THERAPEUTICS. 

16 ‘‘(a) PAYMENT.— 

17 ‘‘(1) IN GENERAL.—Not later than 1 year after 

18 the date of enactment of this section, the Secretary 

19 shall establish a payment methodology for manufac20 turers of prescription digital therapeutics, which 

21 may consist of a one-time payment or periodic pay22 ments, as determined appropriate by the Secretary. 

23 ‘‘(2) CONSIDERATIONS FOR PAYMENT METHOD24 OLOGY.—For purposes of establishing the payment 


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1 methodology under paragraph (1), the Secretary 

2 shall consider— 

3 ‘‘(A) the actual list charge of such pre4 scription digital therapeutic; 

5 ‘‘(B) the weighted median (calculated by 

6 arraying the distribution of all payment rates 

7 reported for the most recent period for which 

8 such rates were reported under subsection 

9 (c)(1) for each prescription digital therapeutic 

10 weighted by volume for each payor and each 

11 manufacturer) for such prescription digital 

12 therapeutic; 

13 ‘‘(C) in the case of a prescription digital 

14 therapeutic that requires ongoing use, the 

15 amount for such ongoing use; and 

16 ‘‘(D) other factors as determined by the 

17 Secretary. 

18 ‘‘(b) CODING.— 

19 ‘‘(1) IN GENERAL.—Not later than 2 years 

20 after the date of enactment of this section, the Sec21 retary shall establish product-specific HCPCS codes 

22 for prescription digital therapeutic covered under 

23 this title. 

24 ‘‘(2) TEMPORARY CODE.—The Secretary shall 

25 adopt temporary product-specific HCPCS codes for 


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1 purposes of providing payment under this title until 

2 a permanent product-specific HCPCS code has been 

3 established under paragraph (1). 

4 ‘‘(c) MANUFACTURER REPORTING.— 

5 ‘‘(1) IN GENERAL.—Beginning on January 1, 

6 2024, each manufacturer of a prescription digital 

7 therapeutic covered under this title shall submit to 

8 the Secretary, at such time and in such manner as 

9 specified by the Secretary, and annually thereafter, 

10 a report describing— 

11 ‘‘(A) the payment rate that was paid by 

12 each private payor for each prescription digital 

13 therapeutic during the period specified by the 

14 Secretary; 

15 ‘‘(B) the volume of such prescription dig16 ital therapeutic distributed to each such payor 

17 for such period; and 

18 ‘‘(C) the number of individual users of 

19 such prescription digital therapeutic for such 

20 period. 

21 ‘‘(2) TREATMENT OF DISCOUNTS.—The pay22 ment rate reported by a manufacturer in accordance 

23 with paragraph (1)(A) shall reflect all discounts, re24 bates, coupons, and other price concessions, includ25 ing those described in section 1847A(c)(3). 


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1 ‘‘(3) CIVIL MONETARY PENALTY.— 

2 ‘‘(A) IN GENERAL.—If the Secretary deter3 mines that a manufacturer has failed to report, 

4 or made a misrepresentation or omission in re5 porting, information under this subsection with 

6 respect to a prescription digital therapeutic, the 

7 Secretary may apply a civil money penalty in an 

8 amount of up to $10,000 per day for each fail9 ure to report or each such misrepresentation or 

10 omission. 

11 ‘‘(B) APPLICATION.—The provisions of 

12 section 1128A (other than subsections (a) and 

13 (b)) shall apply to a civil money penalty under 

14 this paragraph in the same manner as they 

15 apply to a civil money penalty or proceeding 

16 under section 1128A(a). 

17 ‘‘(4) CONFIDENTIALITY.—Information reported 

18 under this subsection shall be treated in the same 

19 manner in which information is disclosed by a manu20 facturer or a wholesaler of a covered outpatient is 

21 treated under section 1927(b)(3)(D). 

22 ‘‘(d) DEFINITIONS.—For purposes of this section: 

23 ‘‘(1) ACTUAL LIST CHARGE.—The term ‘actual 

24 list charge’ means the publicly available payment 

25 rate for a prescription digital therapeutic on the first 


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1 day that such prescription digital therapeutic is 

2 available for purchase by a private payor. 

3 ‘‘(2) HCPCS.—The term ‘HCPCS’ means, with 

4 respect to an item, the code under the Healthcare 

5 Common Procedure Coding System (HCPCS) (or a 

6 successor code) for such item. 

7 ‘‘(3) MANUFACTURER.—The term ‘manufac8 turer’ has the meaning given such term by section 

9 820.3(o) of title 21, Code of Federal Regulations (or 

10 any successor regulation). 

11 ‘‘(4) PRESCRIPTION DIGITAL THERAPEUTIC.— 

12 The term ‘prescription digital therapeutic’ has the 

13 meaning given such term in section 1861(nnn). 

14 ‘‘(5) PRIVATE PAYOR.—The term ‘private 

15 payor’ has the meaning given such term in section 

16 1834A(a)(8).’’. 

17 SEC. 3. COVERAGE OF PRESCRIPTION DIGITAL THERA18 PEUTICS UNDER THE MEDICAID PROGRAM. 

19 Section 1905(a) of the Social Security Act (42 U.S.C. 

20 1396d(a)) is amended— 

21 (1) in paragraph (30), by striking ‘‘; and’’ and 

22 inserting a semicolon; 

23 (2) by redesignating paragraph (31) as para24 graph (32); and 


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1 (3) by inserting the following paragraph after 

2 paragraph (30): 

3 ‘‘(31) prescription digital therapeutics (as de4 fined in section 1861(nnn)); and’’. 

Æ 


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