The Access to Prescription Digital Therapeutics Act of 2025 would expand payer coverage for prescription digital therapeutics (PDTs) under Medicare and Medicaid. The bill defines what qualifies as a PDТ and adds it to Medicare Part B coverage.
It also requires the Secretary to establish a payment methodology, create product-specific HCPCS codes, and implement a manufacturer reporting regime. Medicaid would be amended to include PDTs in its coverage while maintaining strict confidentiality and penalties for noncompliance.
The goal is to create a structured reimbursement framework for software-based therapeutics that are cleared or approved by the FDA.
At a Glance
What It Does
Defines prescription digital therapeutics (PDTs) and adds them to Medicare Part B coverage; requires a federal payment framework, product-specific HCPCS codes, and annual manufacturer reporting; expands Medicaid to cover PDTs.
Who It Affects
FDA-cleared PDTs, private payors, Medicare Part B enrollees, Medicare and Medicaid program administrators, healthcare providers administering PDTs.
Why It Matters
Creates a formal reimbursement pathway for software-based therapies, enabling patient access while establishing pricing, coding, and data-reporting norms for payers and manufacturers.
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What This Bill Actually Does
The bill first defines what counts as a prescription digital therapeutic (PDТ) so payers and providers can uniformly recognize and reimburse them. It then expands Medicare Part B coverage to include PDTs, with the FDA-cleared or approved status, disease indication, software-centric mechanism, and a device exemption defined in the bill.
The act goes on to require a payment methodology to be set within one year, and to create product-specific HCPCS codes within two years, with temporary codes in the interim. Beginning January 1, 2026, manufacturers of PDTs would report payment rates paid by private payors, distribution volumes, and user counts, with confidentiality protections and penalties for noncompliance.
Finally, the bill adds PDTs to Medicaid coverage, ensuring access for beneficiaries under that program. In short, PDTs move from a largely unstructured reimbursement landscape to a formal framework that addresses pricing, coding, payer reporting, and data confidentiality across Medicare and Medicaid.
The Five Things You Need to Know
The bill requires the Secretary to establish a PDТ payment methodology within 1 year of enactment (one-time or ongoing payments).
Product-specific HCPCS codes for PDТs must be created within 2 years, with temporary codes used in the interim.
Starting Jan 1, 2026, manufacturers must annually report private payor payment rates, volumes, and user counts for each PDТ.
A civil monetary penalty regime allows up to $10,000 per day for failure to report or for misrepresentation/omission in PDТ reporting.
Medicaid coverage for prescription digital therapeutics is added by amending the Medicaid statute to include PDТs in 1905(a)(32).
Section-by-Section Breakdown
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Definition of Prescription Digital Therapeutic and Medicare scope
The bill adds a new definition for prescription digital therapeutics (PDTs) to section 1861(nnn), describing PDTs as software-based products that are cleared or approved by the FDA and have a stated indication for prevention, management, or treatment of a medical condition. It specifies that the PDТ must primarily use software to achieve its intended result and that it is a device exempt from 502(f)(1) under 801.109. Section 1861(s)(2) is amended to include PDTs furnished on or after January 1, 2026 as a covered medical service, expanding Medicare’s scope to reimburse these products.
Requirements for prescription digital therapeutics under Medicare
The bill creates a new Medicare payment framework for PDTs. It requires the Secretary to establish a payment methodology within 1 year of enactment, which may be a one-time payment or periodic payments, considering factors such as the actual list charge, a weighted median of payor rates, ongoing-use costs, and other relevant factors. It also directs the creation of product-specific HCPCS codes within 2 years, with temporary codes used until permanent codes are established. Beginning January 1, 2026, manufacturers must annually report private payor payment rates, volumes, and user counts, and must reflect all discounts and other price concessions in the reported rate. A civil monetary penalty regime applies for failures to report or for misrepresentation, up to $10,000 per day, with procedures aligned to existing penalties frameworks. The section also requires confidentiality protections consistent with current law for PDТ-related data.
Medicaid coverage of prescription digital therapeutics
Section 3 amends Section 1905(a) to add prescription digital therapeutics (as defined in 1861(nnn)) to the list of services eligible for Medicaid reimbursement. It redesignates paragraph (32) and inserts the new PDТ provision, thereby expanding Medicaid coverage to PDTs furnished to Medicaid beneficiaries. This ensures PDTs are covered under both Medicare and Medicaid, subject to the payment, coding, and reporting framework established under the bill.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Prescription digital therapeutics manufacturers gain a defined reimbursement pathway, specific HCPCS codes, and mandated reporting that can stabilize pricing and market access.
- Private payors/health plans obtain a standardized framework for PDТ reimbursements and transparent data about rates, volumes, and usage.
- Medicare Part B enrollees gain access to PDTs through covered medical services, enabling integration of software-based therapies into standard care.
- Medicare/Medicaid program administrators (CMS and state Medicaid agencies) obtain uniform rules for PDТ coverage, pricing, and data reporting, improving program stewardship.
- Medicaid beneficiaries gain access to PDТs through Medicaid coverage expansion, broadening therapeutic options under the program.
Who Bears the Cost
- PDТ manufacturers bear costs related to reporting, coding, and compliance with the new payment method and potential penalties.
- Private payors may need to adjust plan designs and reimbursements to align with PDТ payment rates and HCPCS coding.
- Healthcare providers may incur administrative costs to implement PDТ prescribing and documentation.
- Federal and state governments bear implementation and oversight costs to administer the new payment methodology, HCPCS coding, and reporting regimes.
- State Medicaid agencies may face administrative burdens associated with enrolling and processing PDТ coverage and provider reimbursements.
Key Issues
The Core Tension
How to set a fair, sustainable price for PDTs that incentivizes innovation while ensuring patient access, without compromising price transparency or creating uneven cross-payer dynamics.
The bill constructs a comprehensive but complex framework for PDTs that hinges on timely rulemaking, accurate payer data, and robust reporting. A central tension is balancing the need for price transparency with the desire to protect proprietary pricing information, given the confidentiality provisions that shield certain reporting data.
The requirement that manufacturers report private payor rates and user counts—while guaranteeing confidentiality—could limit public scrutiny of pricing. Additionally, tying reimbursement to either a one-time payment or periodic payments raises questions about the long-term cost trajectory of PDTs, especially those requiring ongoing use.
The reliance on product-specific HCPCS codes will demand coordination with the coding community and CMS to avoid misclassification or delayed reimbursement. Finally, Medicaid expansion of PDTs depends on state adoption of the new coverage within existing funding structures, which could introduce variability in access across jurisdictions.
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