laboratory

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On April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. Under the new rule, the FDA will phase out its laboratory developed test (LDT) enforcement discretion policy over a four-year period. The phaseout policy “applies to IVDs that are manufactured and offered as LDTs by laboratories that are certified under CLIA[1] and that meet the regulatory requirements under CLIA to perform high complexity testing, and used within such laboratories, even if those IVDs do not fall within FDA’s traditional understanding of an LDT because they are not designed, manufactured, and used within a single laboratory.”

Covid-19 Pharmacy Testing

CMS has issued a new rule clarifying that its daily Covid-19 reporting via the HHS Teletracking portal is mandatory as a condition of participation in the Medicare program. 42 C.F.R. § 482.42. HHS’s FAQ detailing the hospital reporting requirements can be found here – https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf.  Failure to consistently report throughout the Public Health Emergency…

On April 14, 2020, CMS released a ruling that will increase the reimbursement for tests conducted to detect SARS–CoV–2 (the diagnosis of the virus that causes COVID–19) for tests utilizing “high throughput technologies.” The reimbursement under Medicare Part B for these laboratory tests will be raised from about $51 per test to $100 per test. This increase will begin with tests performed on or after March 18, 2020 and end when the national emergency is over.