LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Weekly Enforcement Report: Lab Owners Charged in 2 Fraud Schemes
The owners face fraud charges in two different schemes, one involving urine drug testing and one involving COVID-19 testing.
OIG Greenlights Pharma Patient Assistance Arrangement
New Advisory Opinion 23-01 is similar to other arrangements the OIG has approved in the past.
FDA Says It’s Prepared to Impose LDT Regulations
If Congress won’t do it, we will, the FDA says of laboratory developed test reform.
Labs Should Be Wary of Improper Billing of G0483 Testing
Recent OIG report says Medicare could have saved up to $215.8 million on at-risk payments for G0483 definitive drug tests.
Federal Court Strikes Down No Surprises Act Dispute Resolution Rules
The rules unfairly favor insurers in out-of-network payment disputes, court says.
Recent Blood-Based Tests May Help Increase Colorectal Cancer Screening
Though not yet recommended for screening by the ACS or other medical groups, recently developed blood-based tests show promise.
Weekly Enforcement Report: Medical Centers Pay Big
Recently announced enforcement actions saw three big settlements, with two of those coming from medical centers.
OIG Sounds the Warning on Overbilling of G0483 Definitive Drug Tests
Labs may be billing Medicare for high-reimbursing and medically unnecessary drug tests, according to the OIG.
Amazon Makes Bold Move into DTC Healthcare Services
Though the e-commerce giant recently closed its acquisition of One Medical, FTC antitrust intervention could disrupt Amazon’s plans.
Weekly Enforcement Report: All Quiet on the Laboratory Front
Though labs were again absent from recent key enforcement actions, sentences were handed down in other healthcare-related cases.
