CMS Proposes Medicare Transitional Coverage Path for Breakthrough Devices. On Thursday, CMS proposed a plan to cover FDA-approved breakthrough medical devices for Medicare patients on a case-by-case basis. The voluntary Transitional Coverage for Emerging Technologies (TCET) pathway would use national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain FDA-approved breakthrough devices. The public comment period on the procedural notice isopen for 60 days.
Lawmakers Send Letters Urging CMS to Finalize Prior Authorization Reforms. On Wednesday, nearly 300 members ofCongress pressed CMS to strengthen and finalize rules to reduce priorauthorization hurdles posed by Medicare Advantage plans. Lawmakers have put off reintroducing the Improving Seniors’ Timely Access to Care Act as they seekways to reduce the bill’s cost, and CMS rulemaking incorporating some of the bill’s provisions could achieve that. The House letter is led by Reps. Suzan Del Bene (D-WA), Mike Kelly (R-PA), Ami Bera (D-CA), and Larry Bucshon (R-IN), and the Senate letter is led by Sens. Roger Marshall (R-KS), Sherrod Brown (D-OH), Kyrsten Sinema (I-AZ), and John Thune (R-SD).
Senators Introduce Bipartisan PBM Accountability Legislation. Senators Jon Tester (D-MT), Shelley Moore-Capito (R-WV), Sherrod Brown (D-OH), and James Lankford (R-OK) introduced the Protect Patient Access to Pharmacies Act (S. 2052), which would improve enforcement of the “any willing pharmacy” law and reform the pharmacy benefit manager (PBM) practice of charging retroactive direct and indirect remuneration (DIR) fees to pharmacies.
PhRMA and Others Sue HHS Over Drug Pricing Provisions of the IRA. The Pharmaceutical Research and Manufacturers of America (PhRMA), alongside the National Infusion Center Association and the Global Colon Cancer Association, filed a complaint Wednesday arguing that the drug price negotiation program put in place by the Inflation Reduction Act is “unconstitutional and a government mandate disguised as negotiation.” The lawsuit seeks a permanent injunction against enforcement of the drug pricing program and excise tax.
House Education and the Workforce Health Subcommittee Holds Hearing on HealthcareCompetition and Transparency. On Wednesday, the Health, Employment, Labor, and Pensions Subcommittee heard from witnesses from the Pharmaceutical Care Management Association (PCMA), Affirmed Rx, Families USA,the Employers’ Forum of Indiana, and the Georgetown University Center on Health Insurance Reforms. Subcommittee members probed witnesses on anti-competitive PBM practices, hospital consolidation, and facility fees.
House Energy and Commerce Oversight Subcommittee Holds Hearing on Medicare Access and CHIP Reauthorization Act. On Wednesday, the E&C Oversight Subcommittee held a hearing on “MACRA Checkup: Assessing Implementation and Challenges that Remain for Patients and Doctors.”
House Energy and Commerce Health Subcommittee Holds Legislative Hearing on SUPPORT Act. The E&C Health Subcommittee held a hearing on “Responding to America's Overdose Crisis: An Examination of Legislation to Build Upon the SUPPORT Act.”