Legislation Tracker
Purpose: This tracker provides an overview of key federal healthcare policies and insurance reforms affecting patient access to prescribed medicines in the U.S. It highlights active legislation and regulatory changes with the potential to impact patient costs, coverage, and access to innovation.
Disclaimer: Due to the evolving political landscape many uncertainties remain. Our aim is to provide a balanced, fact-based assessment. This tracker is neither exhaustive nor an endorsement of specific policies but aims to spotlight key topics and hot-button issues.
About NPLB
No Patient Left Behind (NPLB) is committed to ensuring that breakthrough treatments remain accessible to patients without imposing unsustainable out-of-pocket costs. We advocate for policies that recognize the value of medicines, protect medical innovation, and fix systemic issues in insurance coverage.
As we navigate 2025 and beyond, NPLB remains steadfast in advancing patient-centered reforms that:
Lower or eliminate out-of-pocket costs for patients
Preserve and expedite the development of much-needed cures
Ensure drugs go generic without delay and prevent anti-competitive practices
Encourage all countries to contribute their fair share in incentivizing biomedical innovation
While new leadership in Washington shapes the direction of healthcare policy, our mission remains unchanged: protecting patients from high costs while safeguarding the future of medical innovation.
Drug Pricing & out-of-Pocket Reform
H.R.2553 — Capping Prescription Costs Act
Status: Introduced in Senate (2/11/25), awaiting committee review
Impact: The bill aims to limit annual out-of-pocket expenses for prescription drugs to $2,000 for individuals and $4,000 for families with private insurance and commercial health plans, thereby extending protections similar to those in Medicare Part D to the broader insured population. If enacted, this legislation would extend the $2,000 out-of-pocket cap on drug costs beyond Medicare Part D participants to include private and commercial health plans, reducing financial burdens on millions of insured Americans.
Likelihood of Passage Under Current Administration: MODERATE—bipartisan interest, but insurers and PBMs may resist expansion.
Next Steps: The bill must pass the committee hearings (Senate Committee on Health, Education, Labor, and Pension) before a floor vote is scheduled.
NOTE: The timeline for progression can vary; some bills advance within months, while others may take years or may not progress at all. The committee's schedule, legislative priorities, and the broader political climate all influence the timing.
States Leading the Way: Colorado and Illinois have implemented laws capping monthly copay costs for insulin and other essential medications to improve affordability
More Info/Additional Reading
Senator Reverend Warnock Introduces Legislation to Cap the Cost of Prescription Medication
NPLB Study: New Study Reveals Widespread Concern over Prescription Price Controls, Costs, and Access
H.R. 5376 — Inflation Reduction Act (IRA) Implementation
Status: Ongoing implementation by the Centers for Medicare & Medicaid Services (CMS)
Impact: Expands Medicare’s ability to negotiate drug prices; caps out-of-pocket insulin costs at $35/month for Medicare beneficiaries
NOTE: Does not apply to private insurance or employer-sponsored commercial health plans.
Next Steps: CMS will continue to announce negotiated prices and monitor legal challenges from the pharmaceutical industry, particularly lawsuits filed in federal courts challenging the negotiation process.
More Info/Additional Reading
NPLB Webinar: IRA Webinar: Impact of the Inflation Reduction Act for Biotech Builders… and (how) can it be fixed?
Additional NPLB Resources/Commentary
H.R.4895 — Lowering Drug Costs for American Families Act
Status: Introduced in the House (7/26/2023), Referred to the Subcommittee on Health 12/17/2024; Covered in Executive Business Meeting on 4/3/2025
Impact: Expands Medicare drug negotiations to include more drugs, extends price caps, and further limits price hikes.
Likelihood of Passage Under Current Administration: UNCERTAIN—divided Congress makes passage difficult.
Next Steps: The bill must pass out of committee before being scheduled for a House floor vote.
More Info/Additional Reading
International Reference Pricing (IRP) Proposals
Status: Various legislative and administrative proposals are under discussion, including versions of the Elijah E. Cummings Lower Drug Costs Now Act and previous Trump administration International Pricing Index (IPI) and Most Favored Nation models.
Impact: These proposals would tie U.S. drug prices—particularly for Medicare-covered medicines—to those in other high-income countries. This means the government (Medicare) would pay no more than the lowest price charged in other similar countries for some drugs. While this could lower costs for patients, critics argue it may discourage investment in innovation, reduce R&D funding, and limit access to new therapies.
Likelihood of Passage Under Current Administration: MODERATE—While bipartisan concern over drug prices persists, IRP proposals face strong pushback from the biotech industry and some policymakers. The current administration is likely to revisit international pricing strategies—possibly via executive action or legislation—similar to Trump’s “Most Favored Nation” rule under Medicare Part B.
NOTE: IRP is increasingly seen as synonymous with price negotiation and Medicare rate-setting, both of which could have significant market and innovation implications.
Next Steps: Lawmakers continue to debate reference pricing policies, but no immediate votes are scheduled.
More Info/Additional Reading
Trump Proposes to Lower Drug Prices by Referencing Other Countries
NPLB Explainer: “What’s the big deal about cutting the biggest selling drugs down to just being reasonably profitable?”(Video & slidedeck)
RApport: Battling the consequences of price controls at high altitude
Transparency & Anti-Pharmacy Benefit Manager (PBM) Legislation
H.R.9096, S.2973 — PBM Reform Bills (Pharmacists Fight Back Act, Modernizing & Ensuring PBM Accountability Act)
Status: Various proposals under consideration in both chambers.
Impact: Increases transparency in PBM pricing and rebates, bans spread pricing in Medicaid, and limits PBM control over formularies
Likelihood of Passage Under Current Administration: MODERATE—bipartisan interest but competing priorities.
Next Steps: Bills must pass committee review before reaching full House or Senate votes.
More Info/Additional Reading
AJMC: The Trump Sequel: What to Expect on PBMs, 340B, Drug Pricing, and RFK Jr (November 2024)
H.R.3561 — PATIENT (Promoting Access to Treatments and Increasing Extremely Needed Transparency Act) Act of 2023
Status: Passed out of the House Energy and Commerce Committee and awaiting a vote by the full House of Representatives. If approved, it will proceed to the Senate for consideration. This means it has cleared a key legislative hurdle and is moving through the standard process toward becoming law.
Impact: The PATIENT Act aims to improve transparency in the pharmaceutical supply chain by
Requiring Pharmacy Benefit Managers (PBMs) to report detailed data on rebates, fees, and price concessions.
Prohibiting anti-competitive contracting practices that drive up prescription drug prices.
Increasing transparency around how PBM-negotiated discounts affect patient out-of-pocket costs.
Supporters argue that the bill could reduce drug prices by shedding light on hidden deals between PBMs, insurers, and manufacturers. Critics, including some industry stakeholders, caution that compliance could introduce new administrative burdens.
Likelihood of Passage Under Current Administration: MODERATE—The bill has strong bipartisan support and aligns with the administration's broader goals around transparency and affordability. However, it faces pushback from powerful PBM and insurance industry groups, which could slow its progress.
Next Steps: Awaiting full House vote. If passed, it will be sent to the Senate for consideration. If both chambers pass it in identical form, the bill will proceed to the President’s desk for signature into law.
More Info/Additional Reading
H.R. 3630— No Surprises Act
Status: Existing federal protections under the No Surprises Act are in place, but legal challenges and implementation gaps remain.
Impact: Protects patients from unexpected out-of-network bills for emergency services and certain in-network care scenarios. However, enforcement inconsistencies and lawsuits from providers may weaken these protections.
Likelihood of Further Reform Under Current Administration: MODERATE—Continued support expected, but court decisions and lobbying pressure may influence scope.
Next Steps: Monitor litigation outcomes and any CMS updates on enforcement and implementation.
More Info/Additional Reading
Protecting Access to Innovation
S.150 — Affordable Prescriptions for Patients Act (APPA)
Status: Reintroduced in the Senate on July 12, 2024; currently held at the desk awaiting referral to committee. Earlier versions of the bill have passed the Senate in prior sessions but stalled in the House.
Impact: The bill aims to curb “patent thicketing”—a tactic where drug manufacturers file multiple overlapping patents to delay generic or biosimilar competition. By limiting the number of patents that can be litigated and clarifying what constitutes anti-competitive behavior, the bill seeks to:
Promote earlier market entry of lower-cost biosimilars and generics.
Increase patient access to affordable medicines.
Reduce excessive patent abuse in the pharmaceutical space.
Likelihood of Passage Under Current Administration: LOW—Despite unanimous Senate approval in July 2024, the APPA's progression in the House is uncertain. The pharmaceutical industry's significant lobbying efforts and concerns about potential impacts on innovation contribute to this uncertainty.
Next Steps: The bill must be referred to and approved by the Senate Judiciary Committee before advancing to the Senate floor for debate and vote.
More Info/Additional Reading
H.R.6000 — Cures 2.0 Act
Status: The Cures 2.0 Act (H.R. 6000) was introduced in the House on November 17, 2021, during the 117th Congress. As of April 2025, the bill has not advanced beyond the introduction stage, and no further action has been taken.
Impact: The bill aims to build upon the original 21st Century Cures Act by: expanding research funding, supporting accelerated drug approvals, and improving patient access to clinical trials
Likelihood of Passage Under Current Administration: LOW TO MODERATE—Despite bipartisan interest, the bill has stalled, and its future progression is uncertain without renewed legislative focus.
Next Steps: For the bill to advance, it would need to be reintroduced in the current Congress, followed by committee consideration and potential floor debate.
More Info/Additional Reading
H.R.4758 — Accelerating Kids’ Access to Care Act
Status: In legislative hearings The Accelerating Kids’ Access to Care Act has been introduced in both the House (H.R. 4758) and the Senate (S. 2372) during the 118th Congress. As of April 2025, the House version was reported to the chamber on July 23, 2024, and the Senate version was introduced on February 27, 2025.
Impact: Improves Medicaid coverage portability for children with rare diseases. The legislation seeks to simplify the process for out-of-state pediatric providers to enroll in Medicaid, thereby improving access to specialized medical care for children with complex conditions.
Likelihood of Passage Under Current Administration: MODERATE—The bill has bipartisan support and is backed by strong advocacy from children's health organizations. However, concerns regarding funding and implementation may affect its progression.
Next Steps: The bill requires further consideration in the respective committees before potential floor votes in both chambers.
More Info/Additional Reading
H.R.4385 — Cancer Drug Parity Act
Status: Reintroduced in the Senate on June 15, 2023, by Senators Tina Smith (D-MN) and Jerry Moran (R-KS), and in the House by Representatives Glenn Grothman (R-WI), Suzanne Bonamici (D-OR), and others. Referred to the Committee on Health, Education, Labor, and Pensions.
Impact: The bill aims to ensure that oral anticancer medications are covered by health insurance plans on terms no less favorable than intravenous (IV) treatments, addressing cost disparities that may affect patient access to necessary medications.
Likelihood of Passage Under Current Administration: MODERATE—The bill has bipartisan support, which may enhance its prospects despite a divided Congress.
Next Steps: The bill must pass out of the Senate Committee on Health, Education, Labor, and Pensions before being scheduled for a floor vote.
More Info/Additional Reading
H.R.5539, S.832 — Orphan Cures Act & Ensuring Pathways to Innovative Cures (EPIC) Act
Status: Both have been introduced in Congress and are currently under consideration.
Impact: These bills aim to amend provisions of the Inflation Reduction Act (IRA) that subject small molecule drugs to price controls after nine years, compared to thirteen years for biologics. The proposed legislation seeks to equalize the protection periods, addressing concerns that the current disparity may discourage investment in small molecule drug development. Expect proposed fixes to align protections for biologics (13 years) and small molecules (9 years) under IRA. Positive momentum in support of NPLB’s mission to fix the small molecules “pill penalty.”
Likelihood of Passage Under Current Administration: MODERATE TO HIGH—With the Republican Party controlling both the executive branch and holding a majority in Congress, there is a heightened possibility of efforts to amend key provisions of the IRA. Republican leadership has expressed opposition to the IRA's measures, particularly those related to Medicare drug price negotiations. Anticipate changes to IRA’s pricing negotiation program to shrink the reach of the law, though full repeal appears unlikely. Changes will hopefully address unintended impacts of IRA that are stifling innovation.
Next Steps: The bills are under review by relevant House committees, including the Energy and Commerce Committee and the Ways and Means Committee.
More Info/Additional Reading
H.R.878 — Right to Try Act
Status: Under consideration—potential reforms to expand the scope of FDA’s authority or further limit it are being explored, particularly under a potential second Trump administration.
Impact: Expanding “Right to Try” could accelerate patient access to investigational treatments, including emerging therapies like psychedelics. However, reducing FDA oversight may undermine the agency’s ability to ensure the safety, efficacy, and reliability of drugs before they reach patients
Likelihood of Advancement Under Current Administration: MODERATE TO HIGH— Previous Efforts under the previous Trump administration laid the groundwork for broader deregulation.
Next Steps: Monitor for proposed federal legislation or executive actions that may expand “Right to Try” provisions or weaken FDA regulatory authority.
More Info/Additional Reading
Additional Patient Protections
Use of AI in Claims Review
Status: The use of artificial intelligence (AI) in claims review is under regulatory review, with recent guidance issued by the Department of Health and Human Services (HHS).
Impact: The guidance addresses concerns over AI-driven claim denials and automated decision-making in healthcare coverage, emphasizing the need for nondiscrimination and patient protection.
Likelihood of Passage Under Current Administration: MODERATE—strong consumer protection push.
Next Steps: The regulatory rulemaking process is ongoing, with HHS overseeing the development of appropriate frameworks.
More Info/Additional Reading
S.652 — Safe Step Act
Status: Reintroduced in the Senate on March 2, 2023, as S.652, by a bipartisan group of senators.
Impact: The bill seeks to require group health plans to establish a clear and expedient process for patients and healthcare providers to request exceptions to step therapy protocols, which mandate that patients try and fail on one or more insurer-preferred medications before accessing the originally prescribed treatment.
Likelihood of Passage Under Current Administration: MODERATE—The bill has garnered bipartisan support, but its progression may be influenced by legislative priorities and potential opposition from insurance stakeholders.
Next Steps: The bill has been referred to the Senate Committee on Health, Education, Labor, and Pensions. It requires committee approval before proceeding to a full Senate vote.
More Info/Additional Reading
H.R.8702 — Improving Seniors' Timely Access to Care Act (Prior Authorization)
Status: Introduced in the House with bipartisan support ( 06/12/2024); has gained a majority of cosponsors.12/17/2024 Referred to the Subcommittee on Health
Impact: The bill aims to streamline and standardize prior authorization processes within Medicare Advantage plans to reduce delays and administrative burdens, ensuring timely access to medically necessary care for seniors.
Likelihood of Passage Under Current Administration: HIGH—The bill's broad bipartisan backing and focus on improving senior care enhance its prospects for passage.
Next Steps: The bill must pass out of the relevant committees before being scheduled for floor votes in both the House and Senate.
States Leading the Way (with other Prior Authorization legislation):Texas has pioneered "gold card" legislation, allowing healthcare providers with a high approval rate for prior authorization requests to bypass the process for certain services
More Info/Additional Reading
H.R. 3590 — Affordable Care Act (ACA) Subsidy Reforms
Status: The enhanced premium tax credits under the ACA, expanded by the American Rescue Plan Act and extended through the Inflation Reduction Act, are set to expire at the end of 2025. Enhanced premium tax credits (EPTCs) are tax credits offered by the federal government to help individuals and families purchase health insurance on the insurance marketplaces These credits reduce the insurance premiums based on projected income for the next year. The goal is to increase accessibility and affordability of health coverage by reducing the cost of monthly insurance premiums.
Impact: Limits to eligibility and reforms on income verification processes intend to reduce overpayments in ACA tax credit subsidies. However, critics argue that if the Trump administration decides not to extend premium tax credits (set to expire after 2025), it could cause insurance premiums to rise or become unaffordable for millions, resulting in an estimated 4 million Americans losing coverage and becoming uninsured, according to the Center on Budget and Policy Priorities.
Likelihood of Continuation Under Current Administration: UNCERTAIN—The current administration has indicated a focus on reducing government spending, which may include allowing these subsidies to expire.
Next Steps: Congressional deliberations are expected to address the future of these subsidies before their expiration in 2025.
More Info/Additional Reading
CoPay Accumulator & Patient Assistance Programs (PAPs)
Status: Growing momentum at state level. Awaiting rulemaking announcements from the Centers for Medicare & Medicaid Services (CMS)
Impact: Potential restrictions on co-pay accumulator programs, which currently prevent manufacturer assistance from counting toward patients’ deductibles. Changes could improve affordability for patients relying on such assistance.
Likelihood of Passage Under Current Administration: UNCERTAIN—pending regulatory decisions.
Next Steps: Awaiting CMS announcement. Nothing introduced at the federal level.
States Leading the Way: Virginia, West Virginia, and Arizona have enacted laws requiring insurers to count copay assistance toward patients' deductibles and out-of-pocket maximums
More Info/Additional Reading
Other Important Issues
Problematic Insurance Policies
Independence Blue Cross (IBX) policies exclude coverage for rare disease treatments that have been approved under the FDA’s Accelerated Approval pathway. This exclusion raises concerns about access to critical therapies for patients with rare and often life-threatening conditions, potentially leaving vulnerable populations without necessary care.
TAKE ACTION: Community Sign On Letter
More Info/Additional Reading
Workforce & Funding Cuts Across Federal Health Agencies
Federal agencies like the NIH, NSF, and FDA are facing significant workforce and funding cuts, threatening the foundation of American science and public health. These reductions could impact critical research, regulatory oversight, and healthcare advancements.
TAKE ACTION - Community Sign on Letters:
More Info/Additional Reading
This tracker will be updated periodically as new policies emerge and existing legislation moves through Congress.
The more we know, the more power we have to protect our health and our future—together. Our voice and vigilance matter more than ever. If we don’t pay attention and speak up, patients pay the price.
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