How could the outcome of the Senate and House races affect healthcare funding?

A: Now that Republicans control the White House in addition to both chambers of Congress, we can expect legislators to pass the 12 regular appropriations bills that fund the federal government in a timely fashion rather than waiting until the end of the fiscal year. The challenge for Republicans will be to find common ground among themselves on spending bills, with budget hawks in Congress sure to pressure leadership to reduce government spending and the deficit. It is too early to tell how this might affect the Centers for Disease Control and Prevention, as much depends on political appointments and sometimes-conflicting priorities. The good news, though, is that the National Institutes of Health has received strong bipartisan support over the last few years, so major cuts to medical research funding are not expected.

How might the new administration change the Affordable Care Act (ACA) in ways that affect clinical laboratories?

The incoming Trump administration and Congress have both promised that a priority will be dismantling and replacing the ACA with new healthcare policies. The hard part will be developing healthcare policy that will protect the popular parts of the ACA—which Trump has stated he will keep—while doing away with the unpopular ones. Any immediate or near-term action will probably occur through budget reconciliation, which can be applied only to those elements of the law with budgetary implications, leaving broader repeal in question for the time being. There is no doubt the changes to come will impact the lab community, but until we see the proposals in detail it remains uncertain what that impact will be. In the end, major elements of the ACA are likely to be retained, with complete repeal a nearly impossible scenario.

How could the election results affect Obama’s Precision Medicine Initiative?

Precision medicine has received strong support from Congressional Republicans, and the 21st Century Cures Act—which President Obama signed into law in December—is expected to enhance the initiative. The law will set aside nearly $5 billion to fund a number of National Institutes of Health projects, including the Precision Medicine Initiative.

What will happen to the proposed Food and Drug Administration (FDA) final guidance on laboratory-developed tests (LDTs)?

Because House Republicans have asked all government agencies not to publish any major regulations until after the new president is inaugurated, FDA has decided that it will not finalize its guidance on LDTs prior to the Trump administration taking office. For more details on this development, see “Regulatory Reprieve on Laboratory Developed Tests” on p. 12 of this issue.

What are the top concerns for AACC advocacy efforts under a new administration?

AACC priorities will remain the same with the Trump administration, although we might modify our strategies to reflect the new political environment. We remain committed to pursuing a CLIA-centric approach to regulating LDTs. We do not expect any changes in our harmonization strategy either as the congressional landscape is largely the same. AACC succeeded in getting report language in the Health and Human Services Appropriations bill this year directing CDC to inform Congress of its plans for harmonization. AACC hopes to build upon this success and obtain federal funds for the initiative in 2017.

David D. Koch, PhD, DABCC, FACB, is chair of the AACC Policy and External Affairs Committee; director of clinical chemistry, toxicology, and point-of-care testing at Grady Memorial Hospital; and professor of pathology and laboratory medicine at Emory University in Atlanta.+Email: [email protected]