II 

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. 

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 2022’’. 


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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 ‘‘(lll) PRESCRIPTION DIGITAL THERAPEUTIC.—The 

9 term ‘prescription digital therapeutic’ means a product, 

10 device, internet application, or other technology that— 

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

12 510(k), 513(f)(2), or 515 of the Federal Food, 

13 Drug, and Cosmetic Act; 

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

15 the prevention, management, or treatment of a med16 ical disease, condition, or disorder; 

17 ‘‘(3) primarily uses software to achieve its in18 tended result; and 

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

20 502(f)(1) of the Federal Food, Drug, and Cosmetic 

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

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

23 (b) COVERAGE AS MEDICAL AND OTHER HEALTH

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

25 (42 U.S.C. 1395x(s)(2)) is amended— 


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1 (1) in subparagraph (GG), by striking ‘‘and’’ at 

2 the end; 

3 (2) in subparagraph (HH), by striking the pe4 riod at the end and inserting ‘‘; and’’; and 

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

7 ‘‘(II) prescription digital therapeutics furnished 

8 on or after January 1, 2023;’’. 

9 (c) REQUIREMENTS FOR PRESCRIPTION DIGITAL

10 THERAPEUTICS UNDER MEDICARE.—Part B of the Social 

11 Security Act (42 U.S.C. 1395j et seq.) is amended by in12 serting after section 1834A the following new section: 

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

14 THERAPEUTICS. 

15 ‘‘(a) PAYMENT.— 

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

17 the date of enactment of this section, the Secretary 

18 shall establish a payment methodology for manufac19 turers of prescription digital therapeutics, which 

20 may consist of a one-time payment or periodic pay21 ments, as determined appropriate by the Secretary. 

22 ‘‘(2) CONSIDERATIONS FOR PAYMENT METHOD23 OLOGY.—For purposes of establishing the payment 

24 methodology under paragraph (1), the Secretary 

25 shall consider— 


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1 ‘‘(A) the actual list charge of such pre2 scription digital therapeutic; 

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

4 arraying the distribution of all payment rates 

5 reported for the most recent period for which 

6 such rates were reported under subsection 

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

8 weighted by volume for each payor and each 

9 manufacturer) for such prescription digital 

10 therapeutic; 

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

12 therapeutic that requires ongoing use, the 

13 amount for such ongoing use; and 

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

15 Secretary. 

16 ‘‘(b) CODING.— 

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

18 after the date of enactment of this section, the Sec19 retary shall establish product-specific HCPCS codes 

20 for prescription digital therapeutic covered under 

21 this title. 

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

23 adopt temporary product-specific HCPCS codes for 

24 purposes of providing payment under this title until 


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1 a permanent product-specific HCPCS code has been 

2 established under paragraph (1). 

3 ‘‘(c) MANUFACTURER REPORTING.— 

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

5 2023, each manufacturer of a prescription digital 

6 therapeutic covered under this title shall submit to 

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

8 specified by the Secretary, and annually thereafter, 

9 a report describing— 

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

11 each private payor for each prescription digital 

12 therapeutic during the period specified by the 

13 Secretary; 

14 ‘‘(B) the volume of such prescription dig15 ital therapeutic distributed to each such payor 

16 for such period; and 

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

18 such prescription digital therapeutic for such 

19 period. 

20 ‘‘(2) TREATMENT OF DISCOUNTS.—The pay21 ment rate reported by a manufacturer in accordance 

22 with paragraph (1)(A) shall reflect all discounts, re23 bates, coupons, and other price concessions, includ24 ing those described in section 1847A(c)(3). 

25 ‘‘(3) CIVIL MONETARY PENALTY.— 


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1 ‘‘(A) IN GENERAL.—If the Secretary deter2 mines that a manufacturer has failed to report, 

3 or made a misrepresentation or omission in re4 porting, information under this subsection with 

5 respect to a prescription digital therapeutic, the 

6 Secretary may apply a civil money penalty in an 

7 amount of up to $10,000 per day for each fail8 ure to report or each such misrepresentation or 

9 omission. 

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

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

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

13 this paragraph in the same manner as they 

14 apply to a civil money penalty or proceeding 

15 under section 1128A(a). 

16 ‘‘(4) CONFIDENTIALITY.—Information reported 

17 under this subsection shall be treated in the same 

18 manner in which information disclosed by a manu19 facturer or a wholesaler of a covered outpatient drug 

20 is treated under section 1927(b)(3)(D). 

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

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

23 list charge’ means the publicly available payment 

24 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(lll). 

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(lll)); and’’. 

Æ 


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