On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more
3/6/2013 - Affordable Care Act CMS Healthcare Manufacturers Medical Devices Pharmaceutical Physicians Reporting Requirements Research Funding Sunshine Act
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002...more
2/25/2013 - Affordable Care Act Applicable Manufacturers Biologics CMS Drug Manufacturers Failure to Report GPOs Medical Devices Medical Supplies Payment Records Penalties Physician Investment Interests Physician Ownership Physicians Reporting Requirements Stark Law Sunshine Act Teaching Hospitals
The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more
1/7/2013 - DOJ Drug Compounding FDA FDCA Officers Park Doctrine Pharmacies
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