Tag Archives: Legal issues/actions (see also Medical mistakes, Laboratory errors)

February 2017—A laboratory’s proposal to provide free labeling services to some of its dialysis center clients poses more than a minimal risk of fraud and abuse, according to an advisory opinion from the Office of Inspector General of the U.S. Department of Health and Human Services.

February 2017—The Association for Molecular Pathology belongs to a small and exclusive club of plaintiffs on the winning side of a unanimous U.S. Supreme Court decision. Such a ruling was issued in 2013 in the case of AMP v Myriad Genetics, a suit sponsored by the American Civil Liberties Union with the AMP as lead plaintiff.

March 2015—When the 11th Circuit U.S. Court of Appeals issued an opinion harshly criticizing the CAP’s guidelines on review of Pap tests last summer, many in the pathology community were stunned by the rebuke and wondered whether change was called for.

July 2014—Laboratories now may be saved from draconian penalties, such as loss of a CLIA license and probation periods, for mistakenly sending proficiency test specimens to another facility. Under new rules published by the Centers for Medicare and Medicaid Services, laboratories have the regulatory relief the CAP advocated during the past decade. The CMS will still severely punish those attempting to cheat on proficiency testing, but laboratories that unknowingly or unintentionally refer PT specimens will face alternative sanctions, according to the regulations.

July 2013—The most remarkable fact about the June 13 decision of the Supreme Court in Association for Molecular Pathology v. Myriad Genetics, ___ U.S. ___ (2013), is that both sides are proclaiming victory. The physicians and geneticists who challenged efforts to enforce patents on the BRCA1 and BRCA2 genes are elated that the Court has squarely held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”