CLN - Ask The Expert

How the 2020 Election Could Impact Labs

Ask the Expert: January/February 2021

Patricia Jones, PhD, DABCC, FACB

How could the election results affect the U.S. response to the COVID-19 pandemic?

A: With the election of former Vice-President Joe Biden, there may be a more coordinated, comprehensive federal approach to managing the COVID-19 pandemic. One of Biden’s first acts as president-elect was to create an advisory board to develop a national plan for addressing the pandemic. To date, the incoming president has also stated that he plans to double the number of drive-through testing sites, mobilize 100,000 people to conduct more contact tracing, and use the Defense Production Act to increase the availability of much-needed supplies. In addition, he has urged the adoption of a national mask mandate to limit the spread of the coronavirus.

Now that the election is over, what does the U.S. government need to do to get the pandemic under control?

As COVID-19 cases surge to record highs, the demand for testing is also increasing, and while labs have the capacity to keep up with it, the supply chain as it stands does not. The federal government therefore needs to improve the coordination and distribution of laboratory testing supplies. While each state has a coordinator to distribute supplies to labs in need, few labs actually know about the existence of these coordinators or what supplies their states have in stock. In addition, the government also needs to find a way to help ramp up supply production in order to increase the number of available kits, reagents, and other materials that laboratories need to conduct SARS-CoV-2 tests.

Do you think we’ll see any further changes with laboratory developed test (LDT) regulation?

The incoming administration is likely to be sympathetic to expanding Food and Drug Administration (FDA) oversight of LDTs, so I would not be surprised to see the agency attempt to expand its authority in this area. However, there is significant congressional opposition to such a move. Earlier this year, Senator Rand Paul (R-Ky.) introduced legislation, the Verified Innovative Testing in American Laboratories Act, which would codify the existing LDT regulatory approach under CLIA. AACC supports this measure. There is also a possibility that Senator Paul might become the next chair of the Senate Health, Education, Labor, and Pensions Committee—the panel that has jurisdiction over this issue—which might further limit congressional action in this area. 

Are there other ways in which the election results could affect labs or the healthcare system?

With the Democrats controlling the White House and the House of Representatives, there might be renewed interest in increasing funding for the key health agencies, such as the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), and FDA. Thus, patient safety might get renewed attention. President-elect Biden has also stated a desire to expand Medicaid and the Affordable Care Act to reduce the number of people without health insurance. On a narrower issue, Biden expressed support for eliminating surprise billing, which occurs when a patient receives a higher than anticipated charge because the provider was out-of-network.   

What are the top concerns for AACC advocacy efforts moving forward?

AACC continues to focus its attention on improving pediatric reference intervals (PRI), harmonizing clinical laboratory test results, preserving patient access to LDTs, and reducing cuts in lab reimbursement set forth under the Protecting Access to Medicare Act. In 2020, AACC increased the number of organizations supporting the PRI initiative to 34 and brought the American Academy of Pediatrics on board. The association hopes to obtain federal funding for the PRI effort in 2022, as well as to increase the federal money allocated to CDC to harmonize test results. AACC will also continue to work with its allies to prevent duplicative regulation of LDTs by FDA and to identify a new payment methodology for determining a fairer reimbursement model for outpatient tests under Medicare. 

Patricia Jones, PhD, DABCC, FACB, is chair of AACC’s Policy and External Affairs Core Committee, a professor of pathology at University of Texas Southwestern Medical Center, and medical director of laboratories at Children’s Medical Center in Dallas. +Email: [email protected]