Cures Bill May Boost Research, Simplify Regulations
At more than 1,000 pages and projected to cost more than $6 billion, the 21st Century Cures Act may be the most consequential piece of health legislation signed into law since the Affordable Care Act. Much of the bill focuses on developing new drugs, but other elements could affect diagnostic testing and research. The law provides $4.8 billion in funding to the National Institutes of Health (NIH) over 10 years, though these funds still are subject to annual appropriations from Congress. Much of this amount—$3.5 billion—is not new, and comes from cutting the Prevention and Public Health Fund that tackled hospital acquired infections, Alzheimer’s, and other diseases. The NIH funding will go toward the Cancer Moonshot program, the Brain Initiative, and Precision Medicine Initiative. Less well-known areas that will receive funding include tick-borne diseases, guidance on using health data for research, and pediatric research.
On the regulatory side, Congress aimed to speed Food and Drug Administration (FDA) review of new medical products by streamlining requirements for both drugs and devices, the latter of which has the potential to make it easier for companies to win approval for new in vitro diagnostics (IVD) tests. Under the law, FDA must audit its review process to ensure it follows the least burdensome requirements and recognizes standards established by third-party organizations for reviewing new products, among other changes.
The law also changes what FDA will require for CLIA waivers, providing greater clarity to IVD manufacturers. The law requires that FDA publish a draft guidance within 12 months that explains the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.
Also included within the law is an AACC-supported bill to support young scientists, the Next Generation Researchers Act. This provision establishes the Next Generation of Researchers Initiative within NIH that will coordinate all current and new NIH policies that promote opportunities for new scientists and earlier research independence. In addition, the measure makes NIH’s loan repayment programs more generous, increasing the amount of loans that NIH can forgive for trainees from $35,000 per year to $50,000.
The law also may offer NIH some relief from red tape, by exempting the agency from the Paperwork Reduction Act, a rule which often carries an ironic import for federal workers who must take much longer to launch new projects in order to comply.
VA Reverses Plan to Allow Nurses to Supervise Lab Testing
The Department of Veterans Affairs (VA) in a final rule has dropped a controversial proposal issued in May 2016 that would have allowed advanced practice nurses to “perform, supervise, and interpret” laboratory testing. AACC had criticized this proposal for going beyond current clinical practice in which certified nurse practitioners order and interpret tests. In a July 2016 comment letter to the VA, AACC asked that the agency remove these provisions from the proposed rule and take steps to work with the laboratory community to protect quality care for veterans.
The VA proposal came less than a month after a Centers for Medicare and Medicaid Services (CMS) CLIA memorandum that equated a bachelor’s degree in nursing to meeting the education requirements for high complexity laboratory testing. AACC urged CMS to suspend this decision and pursue such changes only through the rulemaking process, which requires a government agency to request and respond to public comment. The agency has not yet released more information about this memo. The AACC comment letters on both the VA and CMS proposals are available on www.aacc.org > Health and Science Policy > Advocacy.