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laboratory-developed tests (LDTs). H.R. 6102 would place all IVCT development – both manufactured
and LDTs – under a new regulatory scheme.

Rep. Bucshon said upon the bill’s introduction: “The VALID Act establishes a risk based regulatory
framework that allows for leading edge development and innovation to thrive, while assuring doctors
and patients that their test results are analytically and clinically valid.”

“What we have learned over the years in successfully combating the spread of viruses, such as MERS,
SARS and Ebola, is that time is of the essence,” Rep. DeGette added. Among other provisions, the VALID
Act would permanently remove the requirement that labs and manufacturers obtain FDA pre-approval
of a new test system during national emergencies going forward.

On March 17, 2020, Sen. Rand Paul introduced S. 3512, the Verified Innovative Testing in American
Laboratories Act of 2020 (VITAL Act), which clarifies federal rules governing laboratory-developed tests
(LDTs). Unlike the VALID Act, the VITAL Act would place complete oversight of LDTs under the CLIA
program within HHS and would eliminate any role of the FDA.

Reactions among industry groups to the two partially competing bills were mixed. AACC and the
Association for Molecular Pathology endorsed the VITAL Act, noting that clinical labs that develop their
own tests are already subject to CLIA and that modernizing the CLIA program is the most efficient way to
oversee LDTs.

AdvaMed Dx and CAP oppose the VITAL Act, however, preferring the regulatory framework of the VALID
Act. In a statement opposing the VITAL Act, CAP referred to it as a disruptive effort to redefine LDTs
during a national emergency.

Supreme Court to Hear ACA Challenge during Oct. 2020 Term

The U.S. Supreme Court agreed March 2 to review an appellate court ruling that declared the Affordable
Care Act’s “individual mandate” unconstitutional. The Fifth Circuit Court of Appeals upheld an earlier
ruling by a Texas U.S. District judge that the law’s requirement that individuals buy health insurance or
pay a tax penalty was unconstitutional because the tax penalty for noncompliance had been repealed.
(In 2012 The Supreme Court had upheld the ACA’s individual mandate as a constitutional exercise of
Congress's taxing power.) However, the Appeals Court had disagreed with the district court that the
entire ACA necessarily had to be tossed out as a result.

When the Supreme Court agreed to hear the case, the Fifth Circuit had sent the matter back to the
district court to reconsider what parts of the ACA, if any, could remain on the books without the
individual mandate. The Supreme Court’s decision to take the case short-circuits that process.

The case will be heard during the Court’s 2020-2021 term, which begins the first Monday in October and
typically ends until the next June. With this schedule, it is highly likely that the ACA will remain fully in
effect, although under a cloud, until after the November elections.

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