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Access to Innovative Treatments Act of 2026
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Access to Innovative Treatments Act of 2026 This bill requires the Centers for Medicare & Medicaid Services (CMS) to review adverse national coverage determinations of drugs under Medicare within 30 days of receiving a request to do so. Specifically, the CMS must review within 30 days any denials or limitations of coverage that are inconsistent with the drug's approval by the Food and Drug Administration (FDA). The bill's requirements do not apply if the CMS already conducted such a review within a two-year period. The bill also prohibits the CMS from applying prior coverage determinations that were made for drugs before they were approved by the FDA if such determinations are inconsistent with the drug's approval.
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Filing registrants (2)
2026 · third_quarter · Health Issues
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $2,560,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE
2026 · third_quarter · Medicare/Medicaid
H.R. 247, S. 46 - Health Care Affordability Act of 2025; H.R. 9495 - Department of Defense Appropriations Act, 2027; H.R. 9260 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027; H.R. 9418 - Access to Innovative Treatments Act of 2026; H.R. 6799 - To amend title II of the Social Security Act to eliminate the waiting periods for disability insurance benefits and Medicare coverage for individuals with young-onset Alzheimer's, and for other purposes; Issues related to improving strategies for early detection and prevention of Alzheimers; Issues related to the Affordable Care Act, Medicaid and comprehensive healthcare; Issues related to implementation of PL-119-21; Issues related to coverage for biomarker testing; H.R. 9823 - The Alzheimer's Early Detection Act
Client expense: $150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of
2026 · third_quarter · Health Issues
H.R. 3501, S. 1799 - a bill to amend title XVIII of the Social Security Act to direct CMS to include certain standardized tests for cognitive impairment detection in the Medicare annual wellness visit and initial preventive physical examination; H.R. 5371 - FY2026 Continuing Appropriations and Extensions Act; H.R. 6799 - To amend title II of the Social Security Act to eliminate the waiting periods for disability insurance benefits and Medicare coverage for individuals with young-onset Alzheimer's, and for other purposes; H.R. 6130, S. 3267 - ASAP Act; H.R. 9418 - Access to Innovative Treatments Act of 2026; H.R. 9495 - Department of Defense Appropriations Act, 2027; H.R. 9260 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027; S. 4494 - Durbin Cures Act; Issues related to the Affordable Care Act, Medicaid and comprehensive healthcare; Issues related to implementation of PL-119-21; Issues related to coverage for biomarker testing; H.R. 9823 - The Alzheimer's Early Detection Act
Client expense: $150,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of
2026 · second_quarter · Health Issues
H.R. 3501, S. 1799 - a bill to amend title XVIII of the Social Security Act to direct CMS to include certain standardized tests for cognitive impairment detection in the Medicare annual wellness visit and initial preventive physical examination; H.R. 5371 - FY2026 Continuing Appropriations and Extensions Act; H.R. 6799 - To amend title II of the Social Security Act to eliminate the waiting periods for disability insurance benefits and Medicare coverage for individuals with young-onset Alzheimer's, and for other purposes; H.R. 6130, S. 3267 - ASAP Act; H.R. 9418 - Access to Innovative Treatments Act of 2026; H.R. 9495 - Department of Defense Appropriations Act, 2027; H.R. 9260 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027; Durbin Cures Act; Issues related to the Affordable Care Act, Medicaid and comprehensive healthcare; Issues related to implementation of PL-119-21; Issues related to coverage for biomarker testing
Client expense: $130,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of
2026 · second_quarter · Medicare/Medicaid
H.R. 247, S. 46 - Health Care Affordability Act of 2025; H.R. 9495 - Department of Defense Appropriations Act, 2027; H.R. 9260 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027; H.R. 9418 - Access to Innovative Treatments Act of 2026; H.R. 6799 - To amend title II of the Social Security Act to eliminate the waiting periods for disability insurance benefits and Medicare coverage for individuals with young-onset Alzheimer's, and for other purposes; Issues related to improving strategies for early detection and prevention of Alzheimers; Issues related to the Affordable Care Act, Medicaid and comprehensive healthcare; Issues related to implementation of PL-119-21; Issues related to coverage for biomarker testing
Client expense: $130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of