House to Consider 21st Century Cures Act

Majority Leader Kevin McCarthy (R-CA) has announced that the House of Representatives will consider H.R. 6, the 21st Century Cures Act, this week. The House Committee on Rules will meet to consider the rules for the debate on Wednesday, July 8. Amendments to the legislation are to be filed by Tuesday, July 7.

This legislation that was released in advance of the Committee on Rules consideration includes changes to the regulatory authority of the Food and Drug Administration, as well as provisions focused on health information technology, research, telemedicine, drug manufacturing and development, and young scientists.

While the legislation would increase funding for the National Institutes of Health by approximately $8.75 billion over the next five years, this figure falls short of the $10 billion that the House Committee on Energy and Commerce approved in May. Three Democratic supporters of the legislation – House Committee on Energy and Commerce Ranking Member Frank Pallone (D-NJ), Rep. Diana DeGette (D-CO), and Rep. Gene Green (D-TX) – have expressed their disappointment with this decrease in funding and vowed to find additional means to fill the “funding hole.”

This new version of the legislation includes a Sense of Congress which states that the HIPAA regulation should not be used to prevent proper data sharing. Additionally, new electronic health record interoperability language would require the Department of Health and Human Services to provide rules for interoperability standards and implementation specifications. It would also abolish the Standards Committee and restrict the role of the Office of National Coordinator Policy Committee.

Policymakers have wrestled with how to pay for the bill’s large price tag and some of the offsets have been controversial. A Congressional Budget Office estimate from July 2 states that the legislation would cut federal spending by about $470 million through 2025. The legislation includes the following offsets: drawing down the Strategic Petroleum Reserve; limiting Medicaid payments for durable medical equipment to Medicare rates; changing payments for Part B drugs administered through durable medical equipment and for X-ray imaging; excluding authorized generics from calculation of average manufacturer price; and establishing programs aimed at preventing prescription drug abuse under Medicare Parts C and D. Unlike the previous version of the bill, the current version would not delay certain Medicare prescription drug plan prepayments. America’s Health Insurance Plans (AHIP) had come out against the Medicare Part D offset, and the Advanced Medical Technology Association (AdvaMed) has expressed concerns on the durable medical equipment offset.

The bill currently has 230 bipartisan cosponsors.

This Week’s Hearings:

  • Tuesday, July 7: The Senate Committee on Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security will hold a hearing titled “Small Business Health Care Challenges and Opportunities.”
  • Wednesday, July 8: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Medicaid at 50: Strengthening and Sustaining the Program.”
  • Wednesday, July 8: The House Committee on Rules will meet to determine the rules for debate of H.R. 6, the 21st Century Cures Act.
  • Wednesday, July 8: The Senate Committee on Homeland Security and Governmental Affairs will hold a hearing titled “Stopping an Avian Influenza Threat to Animal and Public Health.”