II 

117TH CONGRESS 

2D SESSION S. 5238 

To require the Administrator of the Centers for Medicare & Medicaid Services 

to provide guidance regarding coverage of prescription digital therapeutics under Medicaid and the State Children’s Health Insurance Program. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 12, 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 require the Administrator of the Centers for Medicare 

& Medicaid Services to provide guidance regarding coverage of prescription digital therapeutics under Medicaid 

and the State Children’s Health Insurance Program. 

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 ‘‘Medicaid and CHIP 

5 Access to Prescription Digital Therapeutics Act’’. 

6 SEC. 2. ASSURANCE OF MEDICAID AND CHIP COVERAGE 

7 FOR PRESCRIPTION DIGITAL THERAPEUTICS. 

8 (a) IN GENERAL.— 


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1 (1) ISSUANCE OF GUIDANCE.—Not later than 6 

2 months after the date of enactment of this section, 

3 the Administrator of the Centers for Medicare & 

4 Medicaid Services shall issue guidance to States that 

5 identifies methods for State Medicaid programs 

6 under title XIX of the Social Security Act (42 

7 U.S.C. 1396 et seq.) and State Children’s Health 

8 Insurance Programs under title XXI of such Act (42 

9 U.S.C. 1397aa et seq.) to provide medical assist10 ance, child health assistance, and pregnancy-related 

11 assistance for prescription digital therapeutics and 

12 claim Federal financial participation for providing 

13 such assistance. 

14 (2) TECHNICAL ASSISTANCE.—The Adminis15 trator of the Centers for Medicare & Medicaid Serv16 ices may make available technical assistance to a 

17 State that seeks to incur an expenditure for pro18 viding medical assistance, child health assistance, or 

19 pregnancy-related assistance for a prescription dig20 ital therapeutic under the State Medicaid program 

21 or the State Children’s Health Insurance Program 

22 within 30 days of the State submitting a request for 

23 such technical assistance, but in no event shall re24 questing or receiving such technical assistance be a 

25 prerequisite for a State providing any such assistVerDate Sep 11 2014 00:35 Dec 19, 2022 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S5238.IS S5238

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1 ance or receiving Federal financial participation for 

2 providing any such assistance. 

3 (3) PRESCRIPTION DIGITAL THERAPEUTIC.—In 

4 this section, the term ‘‘prescription digital thera5 peutic’’ means a product, device, internet applica6 tion, or other technology that— 

7 (A) is cleared or approved by the Food and 

8 Drug Administration pursuant to section 

9 510(k), 513(f)(2), or 515 of the Federal Food, 

10 Drug, and Cosmetic Act; 

11 (B) has a cleared or approved indication 

12 for the prevention, management, or treatment 

13 of a medical disease, condition, or disorder; 

14 (C) primarily uses software to achieve its 

15 intended result; and 

16 (D) is a device that is exempt from section 

17 502(f)(1) of the Federal Food, Drug, and Cos18 metic Act under section 801.109 of title 21 of 

19 the Code of Federal Regulations (or any suc20 cessor regulation). 

21 (b) PROTECTION OF EXISTING MEDICAID AND CHIP 

22 COVERAGE.—Nothing in this section shall be construed to 

23 imply that an expenditure for a prescription digital thera24 peutic that occurred on or before the date of the enact25 ment of this section did not constitute an expenditure for 


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1 medical assistance under a State Medicaid program or for 

2 child health assistance or pregnancy-related assistance 

3 under a State Children’s Health Insurance Program. 

Æ 


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