This article was written by LSI Scholar Walter G. Johnson, class of 2020, who attended the 7th annual Workshop on Regulation and Reimbursement of Molecular Diagnostics.
The Center for Law, Science & Innovation (LSI) recently hosted its Workshop on Regulation and Reimbursement of Molecular Diagnostics. Speakers from various backgrounds shared insights on how current law and policy affect molecular diagnostics and precision medicine, both in the United States and Canada. The final session, however, examined a proposed major change in the regulation of molecular diagnostics. Professor Ralph Hall from the University of Michigan Law School gave the group an update on the Diagnostic Accuracy and Innovation Act (DAIA) and its progress in Congress.
The DAIA was proposed in March 2017 as a discussion draft by Reps. Larry Buschon (R-IN) and Diana DeGette (D-CO), building on a similar proposal from 2015. If enacted, the DAIA would clarify how the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) can regulate molecular diagnostics [and diagnostic tests broadly]. Currently, the FDA regulates test kits made by manufacturers and sold to labs, while CMS oversees tests that individual laboratories build and offer only in-house—so called laboratory developed tests (LDTs). But tensions have been rising over the past several decades, peaking with the FDA releasing draft guidance claiming authority over LDTs in 2014 and then retracting the move a week after the 2016 elections. The DAIA would resolve this by giving FDA oversight on the development of diagnostics and CMS control over performing the tests in the laboratory.
But Professor Hall highlighted that the policies behind the DAIA will not matter much if political forces prevent its enactment. The proposal has, thus far, been just uncontroversial enough to gain some traction with major industry stakeholders—consensus which was previously lacking. At the time Professor Hall presented, the next obstacle was anticipated technical assistance from FDA, which could either move the DAIA forward or place new barriers in its path to a congressional vote. Since the Workshop, the FDA technical assistance has now been issued and was somewhat positive (according to stakeholders), while recommending precertification programs and continuing to express some of the agency’s longstanding concerns. New reports of stakeholder resistance to the DAIA also surfaced after the FDA technical assistance, which could further complicate the proposal’s path in Congress.
Congress has a busy schedule of other health policy issues for the rest of the year, which might leave no time to address the DAIA. Congress has opioid legislation as a high priority, followed by drug pricing issues and new discussion about another push on the Affordable Care Act. With only six months remaining in this legislative session and an upcoming election, it is uncertain if the DAIA will capture enough legislator interest to be considered. And given the possibility of a political shift in the 116th Congress, diagnostics legislation could look different in 2019—if proposed at all. Professor Hall concluded that legislative reform around molecular diagnostics and LDTs has been a story of actual and perceived differences between stakeholders and their needs, yielding little common ground or agreement about how to move forward. While the DAIA represents a step towards consensus, the decades-old issue simply might need a little more time.