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
Don’t Drag Your Feet When Responding to HIPAA Right of Access Requests
The Biden administration OCR has now issued 13 right of access fines, including a whopping $160,000 penalty.
New Cancer Consortium Aims to Improve Access to Precision Diagnostics
Collaboration between several key pharmaceutical companies looks to remove barriers for cancer patients to improve treatment selection.
FDA Issues First Ever Approval for a COVID-19 Breathalyzer
The FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
Labs in Court Weekly Roundup
All of last week’s key cases announced by the DOJ involving the health care industry related to companies settling false claims-related allegations.
Annual Screening for Breast Cancer Survivors Is Declining
Recently published research shows that annual mammography rates for survivors aged 40 to 64 have been dropping since 2009.
False Billing of Urine Drug Tests Costs NC Lab $11.6 Million
Radeas LLC is also required to enter into a five-year corporate integrity agreement as part of the settlement.
Mastermind or Swindled Shareholder? The Balwani Trial Continues
Prosecution insists that Holmes and Balwani were “partners in everything, including their crimes.”
FY 2021 Medicaid Fraud Report Shows Increase in Recoveries
OIG report on Medicaid Fraud Control Unit enforcement activity in fiscal year FY 2021 shows recoveries are up, despite fewer cases.
Recent CE-IVD Marks Mostly Related to Cancer Testing
In CE-IVD-related announcements made over last week, the majority involved the cancer testing market.
Whatever Happened to the Health Care Blank-Check Company?
After peaking in the first quarter of 2021, with 42 SPACs raising a total of $11 billion, the blank-check company craze has fallen off significantly.
