Esther Scherb

Esther Scherb

Subscribe to all posts by Esther Scherb

CMS Publishes Final Rule to Implement PAMA’s Changes to Laboratory Test Reimbursement

Last week, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register its long-awaited final rule implementing the significant payment and related changes for clinical diagnostic laboratory tests under the Medicare Clinical Laboratory Fee Schedule.  The changes were directed by the Protecting Access to Medicare Act of 2014 (“PAMA”), which establishes a new … Continue Reading

FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations

On May 17, 2016, FDA issued draft guidance encouraging clinical investigators to make their electronic data capture (“EDC”) systems interoperable with health care organizations’ electronic health records (“EHRs”).  Although EHRs are generally under the control of health care organizations and institutions (not FDA-regulated entities such as sponsors), when records are used in clinical investigations, FDA … Continue Reading

Reimbursement Considerations in Rare False Claims Act Jury Trial Addressing Off-Label Issues

On April 7, 2016, a Texas jury found by a 10-1 verdict that Abbott Laboratories did not violate the False Claims Act (FCA) in its marketing of biliary stents used off-label for non-coronary vascular stenting procedures.  The verdict—significant in its up to $1 billion exposure in damages—was the culmination of a decade of litigation before … Continue Reading
LexBlog