The Access to Prescription Digital Therapeutics Act is a U.S. Bill that aims to amend titles XVIII and XIX of the Social Security Act, to provide Medicare and Medicaid coverage and reimbursement for prescription digital therapeutics. Initially introduced in the Senate in 2022 and reintroduced in March 2023, the bill would be limited to digital therapeutics that are cleared or authorized by the FDA and prescribed by a health care provider.

What is a prescription digital therapeutic?

In the bill, the term prescription digital therapeutic is defined as a product, device, internet application, or other technology that:

• Is cleared or approved under 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).

Why is an amendment to the Social Securities Act needed?

Currently, the Centers for Medicare and Medicaid Services (CMS) does not have authority under the law to cover PDTs, as Medicare and Medicaid do not have the flexibility to cover these products outside of the defined benefits categories. As a result, manufacturers of PDTs can not get coverage and reimbursement in the same way that medical device and pharmaceutical manufacturers can. Therefore Centers for Medicare & Medicaid Services must establish a Medicare payment methodology for payments to manufacturers that takes into account certain factors (e.g., ongoing use) and manufacturers must report specified information about private payors, subject to civil penalties (Congress 2022).

A summary of the access to prescription digital therapeutics bill

The requirements for prescription digital therapeutics are split into four main sub-sections: payment, coding, manufacturer reporting, and definitions.

(a) Payment: The Secretary is directed to establish a payment methodology for manufacturers of prescription digital therapeutics within one year of the enactment of this section. The payment may consist of a one-time payment or periodic payments, and factors for consideration include the actual list charge, weighted median, ongoing use amount, and other factors as determined by the Secretary.

(b) Coding: Within two years of the enactment, the Secretary is required to establish product-specific HCPCS codes for prescription digital therapeutics covered under Medicare. Temporary codes will be adopted until permanent codes are established.

(c) Manufacturer Reporting: Starting from January 1, 2023, manufacturers of prescription digital therapeutics covered under Medicare must submit annual reports to the Secretary, including payment rates, volume of distribution, and the number of individual users. The reported payment rate should account for all discounts, rebates, coupons, and other price concessions. Failure to report or misrepresentation may result in civil monetary penalties.

(d) Definitions: This subsection provides definitions for terms used in the section, including "actual list charge," "HCPCS," "manufacturer," "prescription digital therapeutic," and "private payor."

In summary, the Access to Prescription Digital Therapeutics Act (of 2022) establishes the definition of prescription digital therapeutics, includes them in Medicare coverage, and outlines payment methodologies, coding procedures, and reporting requirements for manufacturers of these therapeutics under Medicare. The bill has been read twice and is currently referred to the Senate Committee on Finance.