21st Century Cures Act and other lame-duck legislative priorities
Before lawmakers returned to their districts to focus on their campaigns, they approved a spending measure that will keep the government open through Dec. 9, 2016. The measure also appropriated funds to combat the Zika virus, and addressed the water crisis in Flint, Mich. However, when members of Congress return, they will face pressure to fund the government for the remainder of fiscal 2017 and address any remaining legislative priorities.
21st Century Cures Act
Senate Majority Leader Mitch McConnell (R-Ky.) stated recently that the 21st Century Cures legislative proposal could be the most important legislation Congress passes this year. The proposal, a broad package of measures aimed at increasing medical innovation and high-risk/high-return research, is expected to be considered by Congress during the lame-duck session. It was anticipated that a package would be considered earlier in the year, but the legislation was plagued by a lack of consensus over funding issues, particularly increased funding for the National Institutes of Health (NIH).
The House passed its proposal in 2015 (see "Timeline" sidebar). The Senate committee on Health Education Labor and Pensions (HELP) then approved several key provisions, many mirroring the House legislation. These included language to enable a specialized pathway for breakthrough devices and an enhanced emphasis on the "least burdensome" approach to regulating medical technology products. House Speaker Paul Ryan (R-Wisc.) is expected to consolidate the proposals into one comprehensive "Cures" package that he hopes will pass the House and Senate easily before the end of the 114th Congress.
Both proposals are aimed at accelerating innovation, boosting research, streamlining drug and device approvals, and enhancing health information technology (HIT) interoperability. These changes will ultimately improve patient care and outcomes as well as increase the quality, safety, and efficiency of healthcare delivery.
Specifically, the bills will help the NIH and the U.S. Food and Drug Administration (FDA) recruit top talent, improve research focused on women and minorities, and encourage young investigators. The measures also include a system of more rapidly approving drugs and devices by decreasing paperwork and streamlining the approval process. Additionally, the Cures measures will help address the executive branch's "Moonshot Agenda" to advance precision medicine and find a cure for cancer.
The health information technology (HIT) provisions aim to reduce the documentation burden for physicians, improve interoperability, access to information for patients, and physician access to patient medical records. The Senate bill also includes language defining clinician-led clinical data registries and requires that HIT vendors share data with those registries as a condition of certification to ensure such registries have efficient and cost-effective access to clinical outcomes data.
The American Association of Orthopaedic Surgeons (AAOS) has been involved with the development of both the House and Senate bills and strongly supports the proposals. The AAOS recently spearheaded a letter to House Speaker Ryan signed by multiple medical specialties encouraging action on the proposal.
Other legislative priorities
In addition to funding the government and passing the 21st Century Cures Act before the end of the year, legislators may address other issues.
Before heading out, Speaker Ryan said, "When we return in November, I look forward to completing work on some very important key initiatives that just haven't quite gotten over the finish line—Tim Murphy's mental health reform, Fred Upton's 21st Century Cures initiative. Obviously, we passed our water resources bill last night. The Senate's passed theirs. We need to complete work on that. I also am hoping that we can make progress on criminal justice reform."
Julie Williams is the senior manager, government relations, in the AAOS office of government relations. She can be reached at email@example.com
Timeline of Key Federal Actions on the 21st Century Cures Act
May 19, 2015—21st Century Cures Act introduced
The 21st Century Cures Act is a bipartisan bill aimed at reforming the clinical trial process and providing mandatory funding for the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) over the next 5 years, via budget offsets.
May 21, 2015—Bill was reported and amended by the House Energy and Commerce Committee
The U.S. House Committee on Energy and Commerce unanimously passed the 21st Century Cures Act by a vote of 51–0. The committee chair Fred Upton (R-Mich.) is the bill's sponsor, along with 230 cosponsors (121D, 109R).
July 2015—House voted on amendments
In a key vote on the House floor, an amendment that would shift the NIH and FDA funding from mandatory to discretionary was struck down, 141–281.
July 10, 2015—House passed HR6, the 21st Century Cures Act
The bill passed the House by a vote of 344–77, with 12 abstentions, in a bipartisan effort led by House Energy and Commerce Committee Chairman Upton and Ranking Member Diana DeGette (D-Colo.).
January 2015—Senate worked on "Innovation for Healthier Americans" initiative
The Senate committee on Health, Education, Labor, and Pensions (HELP) started work on this initiative, meant to align with the 21st Century Cures Act.
June 2016—Senate HELP committee working on companion package
Committee Chairman Lamar Alexander (R-Tenn.) has approached this medical research funding push by passing 19 smaller bills through his committee, intended to compile into a companion package for the 21st Century Cures Act.
- Potential actions in the 114th Congress
According to Senate HELP Committee Chairman Alexander, his ability to stitch together 19 bills approved in the committee and bring a package to the floor depends on reaching a funding agreement with Democrats.
- Senate Democrats like Elizabeth Warren (Mass.) and Patty Murray (Wash.) want funding to be mandatory, while Republicans resist that approach.
- Senate Republicans want to make sure other spending is cut to pay for the funding necessary under the 21st Century Cures Act.
- Both Sens. Murray and Alexander are hopeful they will reach a bipartisan agreement on this bill before this Congressional term closes.
- According to GovTrack.US, the bill has a 52 percent chance of being signed into law.