[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 5238 Introduced in Senate (IS)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicaid and CHIP Access to 
Prescription Digital Therapeutics Act''.

SEC. 2. ASSURANCE OF MEDICAID AND CHIP COVERAGE FOR PRESCRIPTION 
              DIGITAL THERAPEUTICS.

    (a) In General.--
            (1) Issuance of guidance.--Not later than 6 months after 
        the date of enactment of this section, the Administrator of the 
        Centers for Medicare & Medicaid Services shall issue guidance 
        to States that identifies methods for State Medicaid programs 
        under title XIX of the Social Security Act (42 U.S.C. 1396 et 
        seq.) and State Children's Health Insurance Programs under 
        title XXI of such Act (42 U.S.C. 1397aa et seq.) to provide 
        medical assistance, child health assistance, and pregnancy-
        related assistance for prescription digital therapeutics and 
        claim Federal financial participation for providing such 
        assistance.
            (2) Technical assistance.--The Administrator of the Centers 
        for Medicare & Medicaid Services may make available technical 
        assistance to a State that seeks to incur an expenditure for 
        providing medical assistance, child health assistance, or 
        pregnancy-related assistance for a prescription digital 
        therapeutic under the State Medicaid program or the State 
        Children's Health Insurance Program within 30 days of the State 
        submitting a request for such technical assistance, but in no 
        event shall requesting or receiving such technical assistance 
        be a prerequisite for a State providing any such assistance or 
        receiving Federal financial participation for providing any 
        such assistance.
            (3) Prescription digital therapeutic.--In this section, the 
        term ``prescription digital therapeutic'' means a product, 
        device, internet application, or other technology that--
                    (A) is cleared or approved by the Food and Drug 
                Administration pursuant to section 510(k), 513(f)(2), 
                or 515 of the Federal Food, Drug, and Cosmetic Act;
                    (B) has a cleared or approved indication for the 
                prevention, management, or treatment of a medical 
                disease, condition, or disorder;
                    (C) primarily uses software to achieve its intended 
                result; and
                    (D) 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) Protection of Existing Medicaid and CHIP Coverage.--Nothing in 
this section shall be construed to imply that an expenditure for a 
prescription digital therapeutic that occurred on or before the date of 
the enactment of this section did not constitute an expenditure for 
medical assistance under a State Medicaid program or for child health 
assistance or pregnancy-related assistance under a State Children's 
Health Insurance Program.
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