As the world continues to grapple with the COVID-19 pandemic that has taken the lives of over 250,000 Americans, and worldwide over 1 million people, this year, an effective vaccine has emerged as our silver bullet – a way for the nation, and the world, to fight back and, in time, begin to return to … Continue Reading
On June 25, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert entitled “Laboratory Payments to Referring Physicians.” While the Alert breaks no new ground (see, e.g., its 1994 Special Fraud Alert), it demonstrates the OIG’s continuing concerns about clinical laboratories’ offering inducements to referring … Continue Reading
On February 6, 2014, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services Office for Civil Rights (HHS OCR) issued a final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide … Continue Reading
This has been a busy week for the Department of Health and Human Services / Office for Civil Rights (HHS/OCR). It has started releasing guidance on various provisions of the Omnibus HIPAA final rule (the “Final Rule”) in advance of the September 23, 2013 compliance date. The guidance includes: 1. Model Notices of Privacy Practices A … Continue Reading
In a long-awaited decision June 13, 2013, the Supreme Court of the United States ruled in Association for Molecular Pathology et al v. Myriad Genetics, Inc. et al that DNA and genes that are found in the human body and merely “isolated,” are not eligible for patenting, while synthetic DNA, known as cDNA, could be … Continue Reading
