Protecting Patient Access to Cancer and Complex Therapies Act
- Bill Number
- H.R. 4299
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-07-07: 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
- 2026-06-26T08:07:01Z
AI-Generated Summary
Purpose of the Legislation
The "Protecting Patient Access to Cancer and Complex Therapies Act" (H.R. 4299) aims to lower out-of-pocket costs for Medicare beneficiaries receiving certain high-cost drugs and biological products under Medicare Part B (which covers outpatient services). It does this by requiring drug manufacturers to pay rebates for "selected drugs" subject to government-negotiated maximum fair prices (MFPs), ensuring beneficiary coinsurance (the portion patients pay after insurance) is based on the lower MFP rather than higher average sales prices, without reducing payments to healthcare providers.
Key Provisions
- Rebate Requirement: Manufacturers of selected drugs (e.g., those negotiated under prior laws like the Inflation Reduction Act) must pay quarterly rebates to Medicare. These rebates cover the difference between:
- The standard payment rate (ASP + 6%, where ASP is the average sales price reported by manufacturers, plus 6% for administration costs).
- The adjusted MFP rate (MFP + 6%).
- Rebates are calculated per unit of drug furnished and deposited into Medicare's trust fund for Part B.
- Beneficiary Coinsurance Adjustment: For these drugs, patients' coinsurance is reduced to 20% of the MFP + 6% amount (instead of the higher ASP + 6%), applied as a percentage of the provider's payment. If an inflation rebate also applies, the lower coinsurance rate is used.
- Reporting and Timing: The Secretary of Health and Human Services (via the Centers for Medicare & Medicaid Services, or CMS) provides manufacturers with quarterly data on drug units furnished and rebate amounts due, starting 6 months after the initial MFP period begins. Manufacturers must pay within 30 days.
- Enforcement: Failure to pay rebates triggers civil money penalties (fines up to $100 per day per affected beneficiary, similar to existing rules). Rebates are in addition to other required payments under Medicare or Medicaid.
- Application to Other Settings: The rules extend to ambulatory surgical centers (ASCs) and outpatient prospective payment system (OPPS) facilities, ensuring consistent coinsurance calculations where drugs are not bundled into service payments.
- Exclusions and Clarifications: Rebates do not affect ASP calculations for future pricing. Manufacturers are not required to sell drugs directly at MFPs outside this rebate system.
Significant Changes to Existing Law
- Amends Section 1847A of the Social Security Act (Medicare payment limits for drugs) by adding a new subsection (j) for MFP-based rebates, while preserving provider payments at ASP + 6%.
- Modifies coinsurance rules in Section 1833 (amounts payable under Part B) to base patient costs on MFPs for selected drugs.
- Updates conforming sections for ASCs (Section 1833(i)), OPPS (Section 1833(t)), and Medicaid rebate disclosures (Section 1927), ensuring rebates align across programs.
- Removes or adjusts prior language that tied Part B drug payments directly to MFPs, shifting to a rebate mechanism to avoid disrupting provider reimbursements.
- Integrates with existing MFP agreements under Section 1193, replacing direct rebate language with references to the new Part B rebate system.
Potential Impacts
- On Citizens (Medicare Beneficiaries): Reduces coinsurance costs for expensive drugs used in cancer and complex therapies, potentially saving patients thousands per treatment course and improving access to care, especially for those in the Part B deductible phase or with high utilization.
- On Government Agencies: CMS gains administrative duties for quarterly reporting and rebate collection, but rebates will lower overall Medicare Part B spending (estimated to save billions over time by capturing price negotiation benefits in outpatient settings). Funds support the program's solvency via the trust fund.
- On International Relations: Minimal direct impact, though it could influence global drug pricing discussions by demonstrating U.S. efforts to control costs on imported or internationally produced biologics.
- Broader Effects: May encourage more drug negotiations under existing laws, but could face implementation challenges if manufacturers delay compliance.
Main Stakeholders Affected
- Drug and Biological Product Manufacturers: Bear the rebate costs, potentially reducing profits on selected drugs but fulfilling MFP agreements.
- Medicare Beneficiaries: Primarily those with chronic conditions requiring Part B-covered drugs (e.g., cancer patients receiving infusions), who benefit from lower copays.
- Healthcare Providers (e.g., Hospitals, Clinics, ASCs): Maintain full ASP + 6% reimbursements, avoiding revenue losses, but must handle adjusted billing for coinsurance.
- CMS and Federal Government: Oversees implementation, rebate collection, and enforcement; gains fiscal relief for Medicare.
- Insurers and Pharmacy Benefit Managers: Indirectly affected through alignment with Medicaid rebates and potential spillover to commercial markets.
Notable Legal, Constitutional, or Political Implications
- Legal: Builds on the Inflation Reduction Act's MFP framework without altering core negotiation authority; reinforces rebate enforcement via existing civil penalties, reducing litigation risks over provider payments. Ensures compliance with Social Security Act requirements for trust fund deposits.
- Constitutional: No apparent challenges, as it involves congressional spending and regulatory powers under the Commerce Clause; avoids takings issues by using rebates rather than forced price cuts.
- Political: Addresses criticisms of prior drug pricing laws by protecting provider payments and patient access, potentially bridging divides between industry (favoring stable reimbursements) and advocates (seeking cost relief). Could influence future debates on expanding MFP to more drugs or settings, amid ongoing tensions over pharmaceutical innovation incentives vs. affordability.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Murphy, Gregory F. [R-NC-3]
Cosponsors (35)
Rep. Gray, Adam [D-CA-13], Rep. Dunn, Neal P. [R-FL-2], Rep. Carter, Earl L. "Buddy" [R-GA-1], Rep. Joyce, John [R-PA-13], Rep. Miller, Carol D. [R-WV-1], Rep. Harris, Andy [R-MD-1], Rep. Kean, Thomas H. [R-NJ-7], Rep. Miller, Max L. [R-OH-7], Rep. Miller-Meeks, Mariannette [R-IA-1], Rep. Kustoff, David [R-TN-8], Rep. Balderson, Troy [R-OH-12], Rep. Kennedy, Mike [R-UT-3], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Kelly, Mike [R-PA-16], Rep. Davis, Donald G. [D-NC-1], Rep. Moore, Blake D. [R-UT-1], Rep. Suozzi, Thomas R. [D-NY-3], Rep. Pfluger, August [R-TX-11], Rep. Gonzalez, Vicente [D-TX-34], Rep. Peters, Scott H. [D-CA-50], Rep. Cuellar, Henry [D-TX-28], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Moran, Nathaniel [R-TX-1], Rep. Gooden, Lance [R-TX-5], Rep. Moskowitz, Jared [D-FL-23], Rep. Tenney, Claudia [R-NY-24], Rep. Sorensen, Eric [D-IL-17], Rep. Crenshaw, Dan [R-TX-2], Rep. Carey, Mike [R-OH-15], Rep. Harrigan, Pat [R-NC-10], Rep. LaHood, Darin [R-IL-16], Rep. Ciscomani, Juan [R-AZ-6], Rep. Veasey, Marc A. [D-TX-33], Rep. Bean, Aaron [R-FL-4], Rep. Van Duyne, Beth [R-TX-24]
Recent Actions
- 2025-07-07: 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.
- 2025-07-07: 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.
- 2025-07-07: Introduced in House
- 2025-07-07: Introduced in House
Bill Versions
- Protecting Patient Access to Cancer and Complex Therapies Act — issued 2025-07-07 — PDF (12 pages)