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Pacira Pharmaceuticals Pays $3.5M to Settle Allegations of Using Grants as Kickbacks

On July 28, 2020, the Department of Justice (DOJ) announced a $3.5 million settlement to resolve allegations against Pacira Pharmaceuticals Inc. that it paid kickbacks to doctors in the form of “bogus” research grants to...more

The CARES Act: Relief for Health Care Providers

The $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law on March 27, 2020, contains significant relief to assist health care providers faced with the double burden of an onslaught of...more

CMS Offers Guidance On Expedited CLIA Certification

Laboratories that perform tests on human materials for the purpose of diagnosis are considered laboratories under the Clinical Laboratory Improvement Amendments (CLIA) and must receive CLIA certification. Basic elements of...more

Responses to the Current Ventilator Shortage: FDA’s Recommendations and Guidance for Industry and Health Care Providers

The Society of Critical Care Medicine estimates that the United States has over 200,000 ventilators, although other organizations have lower estimates. ...more

Beware Billing Medicare for Non-Approved Imported Drugs

Dr. Mark Fleckner, a board-certified New York ophthalmologist, will pay almost $7 million to settle civil fraud claims arising from giving patients imported macular degeneration drugs that had not been evaluated or approved...more

A Cautious First Step From a Bold Administration: Proposed Rule on Clinician Quality-based Payments Incorporates Some, But Not...

On June 30, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule covering the second and future years of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program. The...more

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