On Thursday, May 21, the US House Committee on Energy and Commerce advanced the 21st Century Cures Act (H.R. 6) with a vote of 51-0. Committee Chairman Fred Upton (R-MI) has indicated that he would like to see a full House of Representatives floor vote next month.
The legislation is the product of the bipartisan 21st Century Cures Initiative that was spearheaded by Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) this past year. The Initiative held various events and authored policy papers on topics such as innovating public health agencies, incorporating patient perspectives into the regulatory process, and improving medicine and medical product regulation.
The Act includes an increase of funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), changes to the regulatory authority of the FDA, and provisions focused on research and clinical trials, health information technology and electronic health records, precision medicine, telemedicine, and drug manufacturing and development, among others.
The manager’s amendment includes offsets, which were released after intense negotiations leading up to the markup. Offsets include: drawing down the strategic petroleum reserve, limiting federal Medicaid reimbursement to states for durable medical equipment to Medicare payment rates, limiting federal payment for X-ray imaging services that use film and implementing an Office of Inspector General recommendation to delay certain Medicare prescription drug plan prepayments.
There were several discussion drafts released by the Committee in the months leading up to this markup. Certain policies, including reforms to the 340B Drug Discount Program and Medicare reimbursement for telehealth services, were not included in the legislation that was reported out of Committee.
Leaders of the Senate Committee on Health, Education, Labor, and Pensions (HELP) have begun to hold hearings and form working groups to explore some of the topics addressed in the House’s bill. However, the Senate is unlikely to move companion legislation this year. HELP Committee leaders have indicated that they do not anticipate significant movement on their parallel legislation until early 2016.