Lawmakers are not done looking for a solution to the dispute over regulation of laboratory-developed tests (LDTs), an issue where most industry observers expect President Joe Biden’s administration to have a different approach than his predecessor. Senator Rand Paul of Kentucky has reintroduced the VITAL Act, which would formally place LDT regulation solely under CLIA and separate it from Food and Drug Administration (FDA) oversight. AACC has endorsed the bill.
A very different, but similarly named bill called the VALID Act died in the 116th Congress, but Bloomberg Law reports that Democrats in the House expect to reintroduce it this year. Contrary to the VITAL Act, the VALID Act would define new powers for FDA to regulate LDTs. When first introduced in 2020, the bill was criticized by AACC for promoting duplicative, costly federal regulations that would decrease patient access.
AACC recently wrote to Health and Human Services Secretary Xavier Becerra seeking dialogue on the issue and emphasized that a burdensome, overlapping regulatory structure under FDA, like that of the VALID Act, would force many hospital laboratories to discontinue needed testing. “The creation of a one size fits all regulatory approach would likely harm, rather than improve patient care,” the letter said.
HHS Inks Venture Capital Deal to Tackle Future Pandemics
The Department of Health and Human Services (HHS) is launching a new public-private partnership for pandemic diagnostics, drugs, and vaccines that enables the government to fund new technology alongside private firms using venture capital practices.
Called the BARDA Ventures program, the Biomedical Advanced Research and Development Authority (BARDA) is partnering with the nonprofit organization Global Health Investment Corporation (GHIC) to accelerate development and commercialization of the new technologies. BARDA will spend a minimum of $50 million over 5 years, with potential for up to $500 million over 10 years. To bring in private capital, GHIC will launch a global health security fund with matching dollars from other investors. While BARDA has long collaborated with private companies, the Ventures program will be the first such partnership allowing direct linkage with the investment community.
If successful, profitable investments will compound to BARDA’s benefit: As companies generate investment returns, proceeds from BARDA Ventures funding will be returned to GHIC for reinvestment in BARDA Ventures.
“Pathogens and health security threats constantly evolve and change. To effectively combat them," said BARDA Director Gary Disbrow, PhD. "We need new and innovative ways to tap into the most novel and impactful ideas in the entrepreneurial community. BARDA Ventures will rise to the challenge by engaging that community and leveraging both public and private funds to change the way we prepare for health security threats of the future.”
Biden’s CMS Chief Renews Focus on Expanding ACA
President Biden’s pick for Centers for Medicare and Medicaid Services (CMS) administrator, Chiquita Brooks-LaSure, will oversee a host of consequential programs, including Medicare’s influential coverage and payment policies, and the government’s health insurance marketplace. She’s a former policy official who guided the Affordable Care Act (ACA) through Congress, working for the House Ways and Means Committee. She’s also served as the director of coverage policy for the agency.
Brooks-LaSure is already making clear how the administration will work to support and expand the ACA. She told Kaiser Health News that near the top of the list is dealing with the so-called Medicaid gap—a situation faced by people who cannot afford an ACA marketplace plan, but who live in one of the 21 states that has not expanded Medicaid to cover more low-income residents.
In addition, she’ll face another problem that she hopes to turn into an opportunity: The Medicare trust fund will run out of money in 2026. Brooks-LaSure says she will work with Congress to fix the funding shortfall and also strengthen benefits.