Healthcare Policy Change Feed
7 policy changes detected this week
Today, March 31
House E&C Committee Passes Biosimilar Competition Act (34-17)
House Energy & Commerce Committee advanced the Biosimilar Competition Act with bipartisan support. Key provisions include streamlined FDA biosimilar review, patent dance reform, and 180-day first interchangeable biosimilar exclusivity. Bill moves to House floor.
Dual strategy: Support PharmaCare's floor advocacy while preparing NBC/BioVenture for transition amendments preserving innovation incentives. Coordinate with Grassley-Klobuchar on Senate companion.
CMS Publishes Round 3 IRA Drug Negotiation List — 20 Additional Drugs
CMS published the final Round 3 list of 20 additional drugs for Medicare price negotiation under the IRA. 12 National Biopharma Coalition members have products on the expanded list with combined revenue exposure of $5.2B. First-time inclusion of oncology biologics and gene therapies signals broadening scope.
Convene emergency health practice meeting. Activate Cassidy-Menendez small biotech amendment advocacy. Brief all affected clients within 48 hours. Simultaneously coordinate PatientFirst media strategy to manage cross-client messaging.
Yesterday, March 30
FDA Issues Landmark AI/ML Medical Device Draft Guidance
FDA released comprehensive draft guidance for AI/ML-based software as medical devices. Framework establishes predetermined change control plans allowing continuous algorithm learning, risk-based regulatory tiers, and real-world performance monitoring requirements.
Coordinate HealthTech and MedDevice Alliance joint public comments within 90-day window. Brief Lieu and Young offices on industry support. Prepare Pacific Health implementation case study.
Saturday, March 28
Senate Finance Markup Amends Hospital Outpatient Payment Rule
Senate Finance Committee markup introduced amendments to CMS OPPS proposed rule, expanding site-neutral payment to 12 additional service categories while adding a 3-year transition period for affected hospitals. Amendment also increases quality reporting measures.
Coordinate AHF and Pacific Health opposition on site-neutral expansion scope. Acknowledge 3-year transition as partial win but push for narrower service category list. Brief Wyden staff on West Coast hospital impact data.
Friday, March 27
Senate Finance Holds Hearing on Prescription Drug Affordability Act
Senate Finance Committee held a hearing on S-2847 with testimony from patient advocates, pharma industry representatives, and state affordability board members. Committee Chairman signaled intent to mark up bill within 60 days.
Accelerate NBC opposition strategy — 60-day markup timeline requires immediate action. Counter PatientFirst momentum with innovation investment data. Brief all biopharma clients on hearing takeaways and next steps.
Wednesday, March 25
E&C Health Subcommittee Approves Medical Device Innovation Provisions
House E&C Health Subcommittee approved medical device innovation provisions including 90-day breakthrough device review, AI/ML continuous learning framework, and $200M device innovation grants. Full committee markup scheduled for April.
Build momentum for full E&C markup. Coordinate MedDevice and HealthTech joint Hill day. Brief Murray's HELP Committee staff on Senate companion bill. Prepare Pacific Health innovation partnership story for press.
Tuesday, March 24
Rural Hospital Preservation Act Gains 12th Co-Sponsor — Bipartisan Momentum
Sen. Capito (R-WV) became the 12th co-sponsor of the Rural Hospital Preservation Act, giving the bill strong bipartisan support with 7 Democrats and 5 Republicans. Finance Committee scheduling expected within weeks.
Capitalize on bipartisan momentum. Coordinate AHF and Pacific Health joint advocacy for Finance Committee scheduling. Prepare rural hospital CEO testimonials. Brief HealthTech members on rural telehealth market opportunity.