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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
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
More Time Needed to Evaluate VALID Act, AMP Urges Congress
Key stakeholders hold a briefing to inform lawmakers of the impact of potential new regulations for laboratory developed testing procedures.
White House: Great Progress in Health Care Coverage, but More Work to Be Done
The White House recently provided on update on agencies’ progress in carrying out EO to boost Medicaid and the Affordable Care Act
Biomarkers Found in Breast Milk Could Lead to Better Cancer Screening
Researchers from Clarkson University and the University of Massachusetts Amherst have discovered breast cancer biomarkers in breast milk that could eventually lead to a blood test for better screening for the disease in all risk and age groups, as the biomarkers...