New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
New Advisory Opinion 23-01 is similar to other arrangements the OIG has approved in the past.
If Congress won’t do it, we will, the FDA says of laboratory developed test reform.
Recent OIG report says Medicare could have saved up to $215.8 million on at-risk payments for G0483 definitive drug tests.
The rules unfairly favor insurers in out-of-network payment disputes, court says.
Though not yet recommended for screening by the ACS or other medical groups, recently developed blood-based tests show promise.
Recently announced enforcement actions saw three big settlements, with two of those coming from medical centers.
Labs may be billing Medicare for high-reimbursing and medically unnecessary drug tests, according to the OIG.
Though the e-commerce giant recently closed its acquisition of One Medical, FTC antitrust intervention could disrupt Amazon’s plans.
Though labs were again absent from recent key enforcement actions, sentences were handed down in other healthcare-related cases.
Drying COVID-19 testing demand drove revenues down, but not as much as expected.