On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is the result of ongoing engagement with industry stakeholders. Under the proposal, the FDA generally stands by its position that a complementary risk-based … Continue Reading
On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance addresses conditions under which the FDA does not intend to take action for violations of 505, 502(f)(1) and 501(a)(2)(B) of … Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has finalized sweeping reforms of the Medicare physician fee schedule (MPFS) update framework, as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Beginning in 2017, physicians can choose one of two tracks within its “Quality Payment Program” to determine their MPFS update: reporting … Continue Reading
This post was also written by Matt Wetzel. On Nov. 10, 2008, a bill was introduced in the Texas Senate that would require drug companies to provide annual disclosures of gifts, payments and other economic benefits to health care providers. If passed, Texas would join the ranks of other jurisdictions (the District of Columbia, Maine, … Continue Reading
