Health Law Highlights

FDA Finalizes Rule Regulating Laboratory Developed Tests

Summary of article from Polsinelli, by Suzanne Bassett, Michael Gaba:

The FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) was published on May 6, 2024, and is expected to take effect in 60 days. The rule expands the definition of in vitro diagnostics (IVDs) to include LDTs and will significantly alter the regulatory landscape for LDTs, impacting manufacturers, patients, and healthcare providers. Despite over 6,500 comments, no substantial changes were made from the Proposed Rule to the Final Rule, but there were significant adjustments to enforcement discretion policies. The rule is expected to face legal challenges and potential legislative action from Congress. The Final Rule applies to all IVDs offered as LDTs, regardless of whether the test meets the traditional definition.

Health Law Highlights

FDA Brings Lab Tests Under Federal Oversight

Summary of article from AP News, by Matthew Perrone:

The FDA has finalized a regulation that will gradually introduce oversight for new tests developed by laboratories. The rule mandates that these tests, including those for life-threatening diseases, must demonstrate accurate results within a timeframe of 3.5 to 4 years. However, existing tests will not require federal review and will be grandfathered into approval. All lab tests will need to register with the agency and report any issues. The move has been opposed by the testing industry, which argues it will limit access to critical tests, increase healthcare costs, and stifle innovation.


CMS Encourages Faster COVID-19 Diagnostic Testing

CMS is changing its payment methodology to encourage higher throughput of COVID-19 diagnostic testing. Previously, CMS would reimburse $100 per test

Starting January 1, 2021, Medicare will pay lower the base rate to $75. However, if the laboratory can complete the test within two (2) calendar days from the date the specimens is collected, CMS will reimburse an additional $25 for a total of $100 per test.

To be entitled to this $25 incentive, the laboratory must: a) complete the test in two calendar days or less, and b) complete the majority of their COVID-19 diagnostic tests that use high throughput technology in two calendar days or less for all of their patients (not just their Medicare patients) in the previous month.

Source: Press release: CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing