As proposed, the President’s Precision Medicine Initiative would incorporate a large, volunteer study cohort in innovative ways
Even as a new presidential initiative to boost precision medicine makes headlines, there is uncertainty as to how the program can be funded. The Precision Medicine Initiative was announced by President Obama on January 30, 2015.
Many pathologists, clinical chemists, and medical laboratory scientists recognize that such a program would pump additional funds into the research and development of new diagnostic tests that are designed to aid physicians in their practice of precision medicine.
The big question is how to pay for this initiative. President Obama proposed budgeting $215 million to fund this effort. But such funding must be approved by a Congress that is at odds with the President on nearly every issue. Additionally, The American Clinical Laboratory Association (ACLA) warns that the Food and Drug administration’s (FDA) 2014 announcement to regulate laboratory developed testing services (LDTs) is in conflict with the President’s initiative. (more…)
Medical laboratory continues to operate, retains its CLIA certificate, and maintains that the PT violations at heart of CMS case were inadvertent
One nationally prominent clinical laboratory organization closed its chapter in the ongoing story of CLIA enforcement of the regulations governing the inadvertent referral of proficiency testing specimens. But this chapter ended with an unexpected twist for the Ohio State University Wexner Medical Center (OSUWMC), which was given severe sanctions by officials of the Centers for Medicare & Medicaid Services (CMS), despite recent enactment of a new federal law on the subject of enforcement of CLIA proficiency testing errors.
The settlement between OSUWMC and CMS was announced on January 16. It calls for OSUWMC to:
- Appoint a new medical director for the clinical laboratory,
- Pay $268,000, and
- Provide additional training to the medical laboratory staff in proficiency testing (PT).
New Medical Director Named at OSUWMC’s Clinical Laboratory
OSU named Daniel Sedmak, M.D., to the position of medical director of the clinical laboratory, as part of this resolution with federal officials who administer the Clinical Laboratory Improvement Amendments (CLIA). Sedmak is currently the Chair of the OSU College of Medicine, Department of Pathology and a professor of pathology.
Last month, Ohio State University Wexner Medical Center issued a press release stating that it had resolved pending sanctions assessed against its clinical laboratory by the Centers for Medicare & Medicaid Services for violations of CLIA requirements, including the inadvertent referral of proficiency testing specimens. (Photo by Wikipedia.com.)
Pathologists will welcome this law, which provides more latitude for federal regulators should a medical laboratory inadvertently refer a proficiency testing specimen
Last Tuesday, the clinical laboratory testing industry gained an important measure of regulatory relief after President Obama signed into law the Taking Essential Steps for Testing (TEST) Act of 2012. This law removes severe penalties for medical laboratories that inadvertently violate proficiency testing (PT) requirements.
More specifically, the language of the TEST Act provides guidance to federal regulators to resolve an issue concerning the inadvertent referral of PT specimens as defined by the Clinical Laboratory Improvement Amendments (CLIA) statute of 1988. (See The Dark Report “Congress May Respond to Tough CLIA PT Penalties,” August 6, 2012.) (more…)