The House Energy and Commerce Committee is about to markup the Pandemic and All-Hazards Preparedness Act (PAHPA) and the Senate HELP Committee is soon to follow. The purpose of the Pandemic and All-Hazards Preparedness Act is “to improve the Nation's public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural.” The pending legislation includes updates and new funding streams. See details here and here.

CMS released a proposed rule for Transitional Coverage for Emerging Technologies (TCET) and the open comment period ends August 28. The voluntary program would expedite Medicare coverage for medical products deemed “breakthrough devices” by the Food and Drug Administration (FDA), offering an estimated three to five years of transitional coverage. The goal is to finalize coverage for the medical device no later than six months after FDA clearance. Then, ideally, the device would generate enough evidence to achieve a longer-term Medicare coverage determination. Participating device makers would get access to CMS officials before FDA market authorization. The officials would review early evidence, help manufacturers design studies that might better address payers’ concerns, and offer guidance on the best existing coverage areas. CMS repealed a similar program, Medicare Coverage of Innovative Technology (MCIT), in 2021, citing concerns that it may have covered devices without adequate evidence. See what this means for bioscience innovation here.

Initial details on the House Labor, Health and Human Services, and Education Appropriations Bill includes some cuts to health:

• $43 billion to the National Institutes of Health (NIH), which is $3.8 billion below the FY23 enacted level, and reduces funding for the Office of the Director, the National Institute of Allergy and Infectious Diseases (NIAID), and the new ARPA-H program, which already has $1.5 billion available in unspent funding.
• Supports basic biomedical research investigating cures for cancers, Alzheimer’s disease, other chronic diseases, and rare diseases.

Over 20 healthcare bills are heading to the House floor that address hospital prices, pharmaceutical middlemen, and pandemic preparedness. The House Education and the Workforce Committee approved four bills (H.R. 4509, H.R. 4507, H.R. 4527, and H.R. 4508) to refine surprise medical billing laws to make them more effective. Meanwhile, the House Energy and Commerce Committee health panel today has a markup of 17 health bills that includes reauthorization of PAHPA (H.R. 4420) and the controversial bill (H.R. 3887) that would prohibit children’s hospitals from performing gender-affirming care from accessing Medicare training funding for pediatricians.