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If the bill passes in its current form, PAMA reporting would be delayed until January 2022 and rate cuts scheduled for 2021 would be put off to 2022.
ACLA President Julie Khani emphasized that commercial labs have been performing SARS-CoV-2 testing without confirmation of payment.
The VITAL Act strikes a counterpoint to another bipartisan-backed bill, called VALID, that would give FDA oversight responsibilities over all clinical tests, including LDTs.
The bill, which was introduced in the House and Senate, would resolve longstanding questions around the FDA's authority to regulate laboratory-developed tests.
Senators said they'll narrow the draft bill containing changes to US patent law before submitting it to the Senate Judiciary Committee in July.
A draft bill provides for a major expansion of eligible material, a move the ACLU and AMP said threatens to reduce competition in genetic testing.
Industry organizations like ACLA are seeking changes to the bill, which appears to outlaw standard business practices such as paying sales staff on commission.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.
A tick-borne disease working group recommends the federal government explore using new technologies and repurposing existing ones to improve diagnosis.