Archives: Coverage and Reimbursement

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CMS Finalizes Medicare National Coverage for Diagnostic Next Generation Sequencing Tests

On March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) for Next Generation Sequencing (NGS) as a diagnostic laboratory test for patients with certain advanced stages of cancer. The NCD process was initiated by Foundation Medicine, Inc.’s request for Medicare coverage for its FoundationOne CDx test, the … Continue Reading

CMS Releases Instructions on PAMA Data Reporting

The Centers for Medicare & Medicaid Services (CMS) has now launched the new data reporting process for laboratories under the Protecting Access to Medicare Act (PAMA). Under CMS’s final PAMA rule, applicable laboratories must report private payor rates and other applicable information for certain clinical laboratory tests from a specified six-month data collection period. Additional … Continue Reading

FDA and CMS Permanently Establish Parallel Review

On October 24, 2016, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register announcing the indefinite extension of the Parallel Review Program.  The agencies’ decision was based on “positive experience” from the Parallel Review Pilot Program, which has allowed manufacturers to … Continue Reading

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

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

Call for Expression of Interest to Participate in early dialogue between HTA bodies and healthcare product developers

A call for expression of interest addressed to healthcare product developers who would be interested in engaging in early dialogues (EDs) with Health Technology Assessment (HTA) bodies was launched in December 2013 and will stay open until October 2014.  The call concerns developers of both medicinal products and medical devices. The European Commission defines HTA … Continue Reading

Medtronic Device to Undergo FDA/CMS Parallel Review

In 2011, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) announced a pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations (NCD).  The agencies explained that the goal of the pilot program is to “facilitate the development of … Continue Reading
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