FDA Watch: Agency Launches Database of Complete Response Letters Sent to Drug Manufacturers About Initial Rejections
The early focus is on drug applications, but it could spread to the laboratory test approval process as well
National Lab Reporter
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Articles and Reports
Federal Appellate Decision on EKRA Spells Out How Lab Marketers Can Violate the Law
If clinical lab managers instruct marketing personnel to engage in kickback practices, they also could be held legally accountable
CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Medicaid Fraud Enforcement Trends: Fewer Cases, Higher Penalties
MFCU enforcement activity has rebounded from recent declines but still hasn’t reached pre-pandemic levels, according to a recent OIG report.
OCR Cracks Down on Right of Access Foot Dragging
Thanks to recent federal enforcement initiatives, prompt response to patient PHI requests should be a growing priority for HIPAA compliance.
Regulatory Roundup: New laws, regulations, cases, and enforcement actions affecting labs and the lab industry
This month’s roundup includes the continued court battle between BGI and Illumina, an FCA lawsuit, and the latest version of OSHA’s COVID-19 rule.
Ellume Faces Lawsuit for Not Refunding Costs of Recalled COVID-19 Tests
Company involved in recent Class 1 recalls of COVID-19 rapid tests now faces further fallout by not refunding customers for faulty tests.
CMS Launches Free Medicare Coverage of OTC COVID-19 Rapid Antigen Tests
Starting April 4, Medicare beneficiaries can get eight free tests per month for each month the public health emergency remains in effect.
Lawmakers Squabble as Country Runs Out of COVID-19 Response Money
The relief package agreed to on April 4 appears to have become a collateral victim of a politically incendiary issue regarding immigration.
It Was All Elizabeth Holmes’ Fault, Sunny’s Lawyers Claim
amesh “Sunny” Balwani’s legal team makes the case that Holmes is solely responsible for Theranos misdoings.
New Act Would Mean Wider Medicare Coverage of Genetic Cancer Screening
Legislation would require Medicare to cover genomic cancer testing and follow-up screening for those with a family history of cancer.
ONC Seeking Public Input on Electronic Prior Authorization Standards
The ONC requested input on certification standards for the development and implementation of electronic prior authorization IT products.
Website Ad Doesn’t Bar Qui Tam Suit for Rewards Program Fraud
A new case from the US Court of Appeals for the Ninth Circuit tests how far the public disclosure bar goes.
