Stefanie Doebler’s practice focuses on health care compliance matters for pharmaceutical and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with health care professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.
Last month, FDA issued two final guidances on medical product communications, including communications by medical device companies about unapproved uses of approved/cleared medical products: “Medical Product Communications That Are With the FDA-Required Labeling—Questions and Answers” (CWL Guidance) and “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers” (Payor Guidance). Taken together, … Continue Reading
Medical device manufacturers are just days away from being required to track and report financial arrangements with health care providers, as required by the Physician Payment Sunshine Act (the “Sunshine Act”). (Read the final rule.) Beginning August 1, 2013, most device manufacturers will be required to annually collect data regarding payments and transfers of value … Continue Reading
On February 8, 2013, the Centers for Medicare and Medicaid Services (CMS) published its much-anticipated final rule implementing Section 6002 the Patient Protection and Affordable Care Act, known as the Sunshine Act. The Sunshine Act requires applicable manufacturers to collect and report to CMS data on payments and transfers of value made to physicians and … Continue Reading
On November 27, the Centers for Medicare & Medicaid Services (CMS) sent its final rule implementing the “Sunshine Act” to the Office of Management and Budget (OMB) for review. OMB review and approval is the final step before the regulation is released and published in the Federal Register. CMS published a proposed rule in December … Continue Reading
On November 21, the Massachusetts Public Health Council adopted final regulations governing the definition of “modest meals” provided in connection with an educational presentation by a medical device or pharmaceutical company held outside of a physician’s office or hospital. The regulations finalize emergency amendments adopted in October following changes to the Massachusetts Pharmaceutical and Medical … Continue Reading