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Numerous Lab Industry Priorities at Stake in Upcoming Elections

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NEW YORK – While most of the attention has been on Vice President Kamala Harris and former President Donald Trump in the presidential election, several down-ballot races could also impact a number of pieces of legislation important to the clinical laboratory industry.

Regulation of laboratory-developed tests, Medicare reimbursement rates, and funding to address persistent staffing shortages are among the matters potentially at stake in the coming elections, which, combined with recent and anticipated retirements in the US House of Representatives and Senate, could reshape congressional committees tasked with oversight of issues important to labs.

"I think we're going to see some significant turnover in the committees that are key for laboratory issues and who is going to be chairing those committees," said Mark Birenbaum, executive director of the National Independent Laboratory Association (NILA) and the American Association of Bioanalysts (AAB).

Among the key figures retiring in the House are Rep. Cathy McMorris Rodgers, R-Wash., chair of the House Committee on Energy and Commerce (E&C); Rep. Larry Bucshon, R-Ind., vice chair of the E&C Health subcommittee; and Rep. Anna Eshoo, D-Calif., ranking member of the E&C Health subcommittee.

Other E&C Health subcommittee members who have announced their retirements include Rep. Michael Burgess, R-Texas; Rep. John Sarbanes, D-Md.; Rep. Tony Cárdenas, D-Calif.; and Rep. Lisa Blunt Rochester, D-Del., who is leaving to running for a Senate seat. Additionally, Rep. Brad Wenstrup, R-Ohio; and Rep. Earl Blumenauer, D-Ore., of the Ways and Means Health subcommittee, are retiring.

Beyond the changes in the makeup of relevant House committees, a change in control of the House from Republican to Democratic would usher in new committee leadership. The same is true for the Senate, which is widely expected to flip from Democratic to Republican control following the 2024 elections.

And then, of course, there is the presidential race between Harris and Trump, the outcome of which could also impact certain lab industry priorities — perhaps chief among them the fate of the US Food and Drug Administration's final rule on laboratory-developed tests (LDTs).

PAMA priority

Heading into the election, permanent reform of the Protecting Access to Medicare Act (PAMA) continues to be front of mind for much of the lab industry. Lab stakeholders have for several years advocated for the Saving Access to Laboratory Services Act (SALSA), which would make a number of permanent changes to PAMA, including changes to how lab test prices are reported and calculated, as well as lower caps on price cuts allowed under the law. While SALSA enjoys bipartisan support in the House and Senate, Congress has not passed the bill since its introduction in the summer of 2022. Instead, it has passed a series of one-year delays to PAMA implementation, the latest of which passed last month as part of a continuing resolution.

A major challenge facing SALSA advocates is the fact that preliminary scoring by the Congressional Budget Office in 2022 projected the law to cost around $6 billion over 10 years, while a one-year delay was projected to save around $730 million over 10 years. This has made temporary delays an easier and more attractive option than a permanent fix from a budgeting perspective.

This obstacle still remains, but Jim Flanigan, executive VP of the American Society for Clinical Laboratory Science, suggested that postelection upheaval could provide the necessary momentum for pushing SALSA through during the lame duck session as part of a larger package of healthcare legislation.

"There are issues across Medicare that need to be resolved, and it's possible that during a lame duck session, you'll have Congress in a position where they want to clear the decks," Flanigan said.

He added that in the event that control of the House and Senate flip, there could be "motivation on the part of those who are losing control of their chambers to come together and potentially compromise and solve some of these problems. They'll have a short amount of time where they can, to a greater degree, influence what that legislative solution might be."

"I think the entire focus of the clinical laboratory community during the lame duck session will be on a permanent solution for fixing PAMA," Flanigan said.

Susan Van Meter, president of the American Clinical Laboratory Association, likewise, said her organization is "pushing forward to secure long-term PAMA reform in the lame duck."

NILA's Birenbaum sounded a note of pessimism, however, citing the short length of the lame duck session and the fact that the government will likely still be operating under a continuing resolution, meaning there will still be pressure to contain spending.

"Would you be able to push something through in that short period of time? I think it is going to be very difficult," he said.

He suggested Congress is more likely to take up the bill next year, noting that the bill's prospects could be impacted by the election and the reshuffling of the relevant committees.

"That's something we're going to have to look at in great detail after the election," Birenbaum said. "We may not know who is on these key committees until January, and for legislation next year, of course, that is going to be very important."

Erin Morton, a partner at lobbying firm CRD Associates, which represents NILA, said the group has been working with sponsors of SALSA to move the bill forward, citing in particular Sen. Sherrod Brown, D-Ohio, Sen. Thom Tillis, R-N.C., Rep. Richard Hudson, R-N.C., Rep. Gus Bilirakis, R-Fla., Rep. Brian Fitzpatrick, R-Pa., Rep. Scott Peters, D-Calif., and former Rep. Bill Pascrell, D-N.J. The majority of these legislators will return to Congress next year, but Pascrell passed away in August, and Brown is locked in a tight race with Republican challenger Bernie Moreno.

Looking beyond SALSA, Flanigan said another major priority for ASCLS is legislation to address the workforce shortages in clinical laboratories and other parts of the healthcare system. He cited two bills as potential vehicles — the Medical Laboratory Personnel Shortage Relief Act of 2024, which was introduced in the House by Rep Deborah Ross, D-N.C., and the Bipartisan Primary Care and Health Workforce Act, which was introduced in the Senate in 2023 by Sen. Bernie Sanders, I-Vt.

The House bill, which Flanigan noted is meant to address the clinical lab workforce shortage specifically, would, among other things, provide financial assistance for individuals training for careers in clinical labs as well as grants to help schools recruit and retain students.

"We're in the process of trying to build support for the bill and seeking out co-sponsors with it with the intent that the bill gets reintroduced in the next Congress as part of an overarching effort on the part of the next Congress to provide appropriate resources for the expansion of the healthcare workforce," Flanigan said.

Van Meter highlighted prior authorization as another area where ACLA hopes to see congressional action, saying that increased demands for prior authorization by payors have placed a burden on laboratories, leading to situations where they are either not reimbursed for testing or where they are not able to deliver timely results to patients.

She noted that the US Centers for Medicare & Medicaid Services (CMS) recently issued its CMS Interoperability and Prior Authorization final rule, which starting in 2026, will require payors participating in various federal health insurance programs to accelerate and simplify their prior authorization decisions for expedited requests to within three days and for regular requests to within seven days.

The Improving Seniors' Timely Access to Care Act would address prior authorization in Medicare Advantage programs, requiring participating payors to report to CMS on their levels of prior authorization use and rate of approvals and denials as well as establish an electronic prior authorization system to speed up the process. The bill was initially introduced in 2021 and was passed by the House of Representatives in 2022 but was not passed by the Senate. It was included in the Health Care Price Transparency Act of 2023 and was introduced again this year.

Van Meter also cited pandemic preparedness as a key issue for ACLA, noting that the organization has advocated for Congress to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA), which has been implemented via temporary extensions since it expired in September 2023. She highlighted recent awards made by the US Centers for Disease Control and Prevention to several companies, including ACLA members, for pandemic preparation. In September, the CDC announced awards to Quest Diagnostics, Laboratory Corporation of America, ARUP Laboratories, Aegis Sciences, and Ginkgo Bioworks to partner on the development of tests for avian influenza A (H5N1) and to improve lab testing and data sharing processes to strengthen the country's ability to respond to disease outbreaks.

Matter of FDA LDT rule

The matter of LDT regulation also continues to hang over the industry. While ACLA and other lab stakeholders are currently fighting the FDA's final rule in court, the upcoming elections could impact both the rule's implementation and alternative routes to LDT regulation that Congress might pursue in the future.

Birenbaum suggested that if Harris wins the presidency, the FDA will continue to implement the rule as planned and defend its position in court. If Trump wins, however, "he may want to make some changes at FDA," he added.

Trump's election in 2016 effectively ended the FDA's efforts to regulate LDTs by guidance. In 2020, in the midst of the COVID-19 pandemic, his administration determined that the FDA would not require premarket review of LDTs without notice-and-comment rulemaking.

The recently issued final rule was produced through notice-and-comment rulemaking, Birenbaum noted, and it is uncertain whether a Trump administration would seek to roll it back. The record suggests, though, that it would be more likely to do so than a Harris administration.

Looming changes in Congress could impact future legislation of LDTs if the FDA rule were thrown out in court or otherwise curtailed. With Bucshon retiring, the House is losing one of the sponsors and main proponents of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which was (and for many still remains) the leading legislative vehicle for reforming diagnostics and LDT regulation. On the other hand, McMorris Rodgers, who is also retiring, was one of VALID's more prominent and, as ranking member and then chair of E&C, more powerful opponents. Meanwhile, Rep. Diana DeGette, D-Colo., a co-sponsor and advocate for VALID, is widely expected to take a leadership position on the E&C Health subcommittee in the next Congress.

On the Senate side, a flip to Republican control would likely put Sen. Bill Cassidy, R-La., in charge of the HELP committee. Cassidy has been skeptical of VALID, expressing reservations during a 2022 HELP hearing discussing the bill and advocating for an amendment introduced by Sen. Tommy Tuberville, R-Ala., that would have exempted LDTs developed at academic medical centers from FDA regulation under VALID. In March, Cassidy issued a Request for Information asking for input on diagnostics reform that raised the possibility of handling LDT oversight via updates to CLIA regulations as opposed to giving that authority to the FDA.

For all the business the lab industry has before Congress, it has not been a particularly big spender when it comes to campaign donations. According to nonprofit Open Secrets, which tracks political spending, in the 2024 election cycle four political action committees (PACs) representing the clinical lab industry specifically — PACs for ACLA, ASCLS, Labcorp, and Quest — gave money to candidates for federal office.

As of Sept. 22, those four PACs had donated $459,000, in roughly equal amounts to Democrats and Republicans. By and large, the spending went to members of committees like E&C, Ways & Means, and HELP with oversight of lab industry priorities as well as to members of relevant subcommittees. Many of the leading recipients have been proponents of SALSA, reinforcing the importance of that bill to the industry.

In the House, the leading recipient was SALSA sponsor Pascrell, whose campaign received a total of $30,000. The campaign of Hudson, a member of the E&C Health subcommittee and also lead sponsor of SALSA, received $27,500, while the campaign of another SALSA sponsor, Peters, received $27,000, and the campaign of Rep. Frank Pallone, D-N.J., currently ranking member on the E&C committee and a likely E&C chair if Democrats flip the House, received $26,000.

In the Senate, the campaign of Brown, a leading SALSA proponent running in a particularly tight race, received the largest amount of donations, $24,500. The campaign of Cassidy, who is poised to take over as HELP chair if Republicans win the Senate, received the second-largest amount with $8,500. The campaign of SALSA sponsor Tillis received $7,500.