Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
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”
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
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.
HHS Signals that the End of the PHE Is Near
Last week, CMS announced that it was eliminating certain waivers and regulatory flexibility it provided when the COVID-19 pandemic began.
Labs in Court Weekly Roundup
While labs weren’t featured in this week’s enforcement actions, clinics and hospitals, and individuals involved in these organizations, were in hot water, mainly for False Claims Act violations. April 6: The former owner of a cash-only pain management clinic in...
OSHA Releases Scaled-Down Health Care Worker COVID-19 Protection Rule
The kinder, gentler version of the standard removes key controversial elements, such as mandating vaccination for employees.
CMS Delays Start of Radiation Oncology Model
The model, meant to start Jan. 1 of this year, had already been delayed over concerns from key stakeholders, and its start date is now TBD
