Section 1 Short title
This Act may be cited as the “Medicaid and CHIP Access to Prescription Digital Therapeutics Act”.
Medicaid and CHIP Access to Prescription Digital Therapeutics Act
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.
Sec. 2 Assurance of Medicaid and CHIP coverage for prescription digital therapeutics
In general—
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.
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.
Prescription digital therapeutic— In this section, the term prescription digital therapeutic means a product, device, internet application, or other technology that—
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;
has a cleared or approved indication for the prevention, management, or treatment of a medical disease, condition, or disorder;
primarily uses software to achieve its intended result; and
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).
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.