- Potential benefitExpands Medicare and Medicaid coverage for FDA-cleared, software-first digital therapeutics starting in 2026.
- ManufacturersCreates clearer payment rules and HCPCS codes, reducing billing and reimbursement uncertainty for providers and manufac…
- ManufacturersManufacturer reporting could increase price transparency across payors, potentially encouraging lower private payor pri…
Access to Prescription Digital Therapeutics Act of 2025
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for c…
This bill amends Titles XVIII and XIX of the Social Security Act to define "prescription digital therapeutics" (PDTs) and require coverage under Medicare (Part B) and Medicaid beginning January 1, 2026. It directs HHS to create a Medicare payment methodology within one year, establish HCPCS coding (with temporary codes) within two years, and mandates annual manufacturer reporting of private-payor payment rates, volumes, and user counts, with civil monetary penalties for misreporting.
Liberal emphasizes access, equity, and stronger price/privacy safeguards
Relative to its intended legislative type, this bill is a substantive policy change that is well-structured in statutory amendments and definitions and provides concrete procedural deadlines and reporting requirements, but it relies heavily on delegated rulemaking for critical payment and operational details and omits fiscal and some operational specifics.
This bill amends Titles XVIII and XIX of the Social Security Act to define "prescription digital therapeutics" (PDTs) and require coverage under Medicare (Part B) and Medicaid beginning January 1, 2026.
It directs HHS to create a Medicare payment methodology within one year, establish HCPCS coding (with temporary codes) within two years, and mandates annual manufacturer reporting of private-payor payment rates, volumes, and user counts, with civil monetary penalties for misreporting.
Medicaid coverage of PDTs is added to the list of mandatory covered services.
Technocratic, moderately scoped expansion with measurable fiscal effects; could pass as part of larger health package but faces cost and stakeholder negotiation.
Relative to its intended legislative type, this bill is a substantive policy change that is well-structured in statutory amendments and definitions and provides concrete procedural deadlines and reporting requirements, but it relies heavily on delegated rulemaking for critical payment and operational details and omits fiscal and some operational specifics.
Liberal emphasizes access, equity, and stronger price/privacy safeguards
Who stands to gain, and who may push back.
These are examples from the analysis, not a ranked list of the most-affected groups.
- Federal agenciesLikely increases federal Medicare and Medicaid spending by adding a new covered category of products.
- ManufacturersImposes new administrative and compliance burdens on manufacturers to report detailed pricing, volume, and user data.
- Potential burdenCreates potential privacy and confidentiality concerns from mandatory reporting of user counts and distribution volumes.
Why the argument around this bill splits.
Liberal emphasizes access, equity, and stronger price/privacy safeguards
Generally supportive because the bill expands access to evidence-based digital treatments and includes Medicaid.
Sees reporting and coding requirements as tools for transparency and equitable coverage.
Will be wary about pricing, patient privacy, and equitable access for low-income and rural patients without devices or broadband.
Cautiously favorable: it pragmatically creates reimbursement pathways and transparency for a growing category of therapies while leaving payment design to HHS.
Wants clarity on fiscal impact, administrative timelines, and how codes interact with existing services.
Prefers measured implementation and oversight to limit waste.
Skeptical: appreciates innovation but worried this mandates expanded entitlement spending and creates new regulatory and reporting burdens.
Concerned about federal expansion into medical coverage decisions and potential long-term cost growth without clear offsets or state flexibility.
The path through Congress.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Technocratic, moderately scoped expansion with measurable fiscal effects; could pass as part of larger health package but faces cost and stakeholder negotiation.
- No official cost estimate or CBO score included
- Private payor and manufacturer support unknown
Recent votes on the bill.
No vote history yet
The bill has not accumulated any surfaced votes yet.
Go deeper than the headline read.
Liberal emphasizes access, equity, and stronger price/privacy safeguards
Technocratic, moderately scoped expansion with measurable fiscal effects; could pass as part of larger health package but faces cost and st…
Relative to its intended legislative type, this bill is a substantive policy change that is well-structured in statutory amendments and definitions and provides concrete procedural deadlines and reporting requirements,…
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.