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
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Details |
Additional Reading
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Capping
Prescription Costs Act |
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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 |
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 |
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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. |
CMS IRA Implementation Overview 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 |
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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. |
Senate Committee Advances Bills To Curb Drug Price Abuses, “Product Hopping” With Patents |
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International Reference Pricing (IRP)
Proposals |
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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. |
Congressional Budget Office
Analysis 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
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Specific Issue/Bill |
Details |
More Info/ Additional Reading
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H.R.9096, S.2973
PBM Reform Bills ( |
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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. |
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 |
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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. |
Full Text of the PATIENT Act
(H.R. 3561) House Energy & Commerce
Committee Summary KFF Explainer: Understanding the
Role of PBMs |
H.R. 3630
No Surprises Act |
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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. |
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PROTECTING ACCESS TO INNOVATION
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Specific Issue/Bill |
Details |
More Info/ Additional Reading
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S.150
Affordable Prescriptions for Patients
Act (APPA) |
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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. |
Biosimilars Council Applauds
Senate Passage of Cornyn-Blumenthal Patent Thicket Legislation Potential Impact of the
Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations |
H.R.6000
Cures 2.0 Act |
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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. |
Policy Primers 21st Century Cures
Act & Cures 2.0 Cures 2.0 Legislation: What Does
it Mean for Health Innovation? |
H.R.4758
Accelerating Kids’ Access to Care Act |
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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. |
Co-sponsor the Accelerating Kids'
Access to Care Act |
H.R.4385
Cancer Drug Parity Act |
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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. |
Senator Tina Smith's Press
Release |
H.R.5539, S.832
Orphan Cures Act & Ensuring Pathways to Innovative Cures (EPIC)
Act
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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. |
Rotten to the Core: The Inflation
Reduction Act Pill Penalty EPIC Act introduced to correct
IRA’s ‘pill penalty’ Fixing the IRA: The EPIC Act,
MINI Act, and ORPHAN Cures Act |
H.R.878
Right to Try
Act |
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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. |
Critics Warn Right-to-Try Law May
Lower Standards for Drug Approvals |
ADDITIONAL PATIENT PROTECTIONS
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Specific Issue/Bill |
Details |
More Info/ Additional Reading
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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. |
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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. |
PAN Foundation joins over 100
healthcare allies asking Congress to advance the Safe Step Act |
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 |
Prior authorization fixes earn
majority support in Congress |
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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. |
Without the enhanced premium tax
credit, millions could lose insurance Trump Will Decide on ACA
Subsidies, Could Raise Insurance Premiums Unpacking The Great Obamacare
Enrollment Fraud: How the Exchanges Became the Wild West |
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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 |
How Copay Accumulators and
Maximizers Affect Pharma PAPs State Legislation Against Copay
Accumulators State Copay Accumulator Bans Will
Affect 19% of US Commercial Lives |
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OTHER IMPORTANT ISSUES |
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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 |
IBX Excludes Coverage of Drugs with Accelerated Approvals for 18
Months |
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● 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: ● Defending the
NIH, the NSF, and the foundation of American science
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Open letter regarding proposed FDA budget cuts ●
Preserving and Modernizing the FDA |
Trump Aims for Deep Funding Cuts Across Federal Health Agencies Here's where jobs and programs are being cut at the nation's top
health agencies |
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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.
Stay in the loop with NPLB!
