PAAT Act
- Bill Number
- H.R. 5467
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-09-18: 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 consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2025-11-20T09:06:41Z
AI-Generated Summary
Purpose
The Patient Access to Autoimmune Treatments Act (PAAT Act), H.R. 5467, aims to improve access to essential medications for Medicare beneficiaries by mandating coverage of specific drugs under Medicare Part D (the prescription drug benefit program) and limiting administrative barriers like prior authorizations for treatments of autoimmune diseases, hemophilia, and Von Willebrand disease.
Key Provisions
- Mandatory Drug Coverage: Starting in 2027, prescription drug plan (PDP) sponsors must include in their formularies (lists of covered drugs) all covered Part D drugs that are indicated and prescribed for treating autoimmune diseases, hemophilia (a genetic bleeding disorder), or Von Willebrand disease (another inherited bleeding disorder).
- Limits on Prior Authorization: For plan years beginning on or after January 1, 2027, PDP sponsors and Medicare Advantage plans with prescription drug coverage (MA-PD plans) cannot require prior authorization (pre-approval from the plan before a drug is covered) more than once every 12 months for these specified drugs. Exceptions apply if the drug is:
- Typically used for 12 months or less.
- An opioid, benzodiazepine (a type of sedative), barbiturate (a sedative-hypnotic drug), or carisoprodol (a muscle relaxant, often controlled).
- Subject to a risk evaluation and mitigation strategy (REMS), which is a safety program required by the FDA for drugs with serious risks.
Significant Changes to Existing Law
- Amends Section 1860D-4 of the Social Security Act, which governs PDP operations.
- Adds a new requirement for automatic inclusion of autoimmune and blood disorder drugs in plan formularies, shifting from optional coverage to mandatory.
- Introduces a cap on prior authorization frequency for these drugs, reducing repetitive administrative hurdles that previously allowed plans to require approvals multiple times a year. This also involves minor technical updates, such as redesignating an existing paragraph.
Potential Impacts
- On Citizens: Enhances access to critical, often lifelong treatments for Medicare enrollees (typically those 65 and older or with disabilities) suffering from autoimmune conditions (e.g., rheumatoid arthritis, lupus) or bleeding disorders, potentially reducing delays in care, improving health outcomes, and lowering out-of-pocket costs from denied claims.
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) may need to update oversight and enforcement rules for Part D plans, possibly increasing administrative workload but aligning with broader goals of affordable drug access under Medicare.
- On International Relations: No direct impacts, as this is a domestic healthcare policy focused on U.S. Medicare programs.
Main Stakeholders Affected
- Medicare Beneficiaries: Primarily those with autoimmune diseases, hemophilia, or Von Willebrand disease, who gain easier access to needed drugs.
- PDP Sponsors and MA-PD Plans: Private insurers offering Part D coverage, required to adjust formularies and prior authorization processes, which could affect their operational costs and benefit designs.
- Pharmaceutical Manufacturers: Companies producing these drugs may see increased demand and reimbursements under Medicare, but must comply with any related FDA requirements like REMS.
- Healthcare Providers: Doctors and specialists prescribing these medications, benefiting from fewer authorization delays.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens patient protections under Medicare by limiting plan discretion on coverage and approvals, potentially reducing litigation over claim denials. Aligns with federal drug safety laws (e.g., FDA's REMS under the Federal Food, Drug, and Cosmetic Act) by preserving exceptions for high-risk drugs.
- Constitutional: No apparent challenges; it operates within Congress's authority to regulate interstate commerce and social welfare programs like Social Security.
- Political: Bipartisan sponsorship (introduced by Reps. Johnson (D-TX) and Kennedy (R-UT)) signals broad support for chronic disease management in Medicare, amid ongoing debates on drug pricing and access. Could influence future reforms by setting precedents for mandatory coverage of specialized therapies, though it may raise concerns about added costs to the Medicare trust fund without offsetting savings.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (5)
Rep. Kennedy, Mike [R-UT-3], Rep. Elfreth, Sarah [D-MD-3], Rep. Cleaver, Emanuel [D-MO-5], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Gottheimer, Josh [D-NJ-5]
Recent Actions
- 2025-09-18: 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 consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-09-18: 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 consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-09-18: Introduced in House
- 2025-09-18: Introduced in House
Bill Versions
- Patient Access to Autoimmune Treatments Act — issued 2025-09-18 — PDF (3 pages)