ENFORCEMENT

Another Decision in the HDL Case Highlights Kickback Risks of Patient Responsibility Waivers Involving Private Payers

The Health Diagnostics Laboratory, Inc. (HDL) and Singulex saga continues. The latest chapter involves not the labs themselves but BlueWave Healthcare Consultants, their marketing firm. And it raises … [Read more...]

ENFORCEMENT

FDA Sends 14 Warning Letters Regarding Cancer Products

The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]

FEE SCHEDULES

CORRECTION: Molecular Assays Stave Off Big Cuts in 2017 Clinical Laboratory Fee Schedule

  Editor's Note: The lead story in the November 25, 2016 issue of LIR is about changes to the 2017 Clinical Laboratory Fee Schedule affecting reimbursement for clinical laboratory tests. The … [Read more...]

FDA

FDA Exempts Certain Class I Devices, Test Kits from 510(k) Filing

The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present … [Read more...]

GENETIC TESTING

Genetic Test Evaluation Framework to Aid Clinical Usefulness of Testing

Anew report by the National Academies of Sciences, Engineering, and Medicine provides a new decision framework for the use of genetic tests in clinical care. An Evidence Framework for Genetic Testing … [Read more...]

HEALTH CARE REFORM

Potential Negative Impact of AHCA on Genetic Testing

While it remains uncertain what the Senate will do with the American Health Care Act (AHCA), alarm is spreading about the legislation's implications for the estimated quarter of Americans under the … [Read more...]

HEALTH CARE REFORM

Value of Price Transparency Questioned

Publishing testing prices in electronic ordering systems for inpatients may not lead to significant changes in clinician ordering behavior or associated fees, according to a study published April 21 … [Read more...]

LEGISLATION

Senate Renews Efforts to Reform LCD Processes

Efforts to improve the local coverage determination process have been renewed with the introduction of the Local Coverage Determination Clarification Act of 2017. The proposed bill is the result of … [Read more...]

HEALTH CARE REFORM

Will AHCA Adversely Affect Genetic Testing?

While it remains uncertain what the Senate will do with the American Health Care Act (AHCA), alarm is spreading about the legislation's implications for the estimated quarter of Americans under the … [Read more...]

FDA

FDA Reports Advances in Diagnostics Development

The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and … [Read more...]


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