Many changes in laws and ethical codes that govern interactions between industry and physicians and other health care
professionals have occurred in recent years.
EndoShape has decided to commit to the AdvaMed Code of Ethics and remains a strong supporter of this important Industry code. We respect the obligation of physicians and other health care providers to make independent decisions that are in the best interest of patient care. Selection of medical devices should be based solely on their effectiveness, quality, and value.
The U.S. Physician Payment Sunshine Act, a provision of the Patient Protection and Affordable Care Act, is a U.S. federal law that requires pharmaceutical, biologic, and medical device manufacturers to track and report payments and transfers of value provided to U.S. physicians and teaching hospitals. If a company such as EndoShape makes a "payment or transfer of value" to a U.S. physician or teaching hospital (a meal, travel, lodging, etc.), the company must provide information about the interaction to the U.S. government. The U.S. Sunshine Act applies to interactions with U.S. physicians regardless of the country where those interactions occur.
Payments and transfers of value that EndoShape must capture and report include expenses such as travel, lodging and meals, consulting payments, royalty payments and licensing fees, research and clinical-trial related expenditures, educational items such as textbooks and journal reprints, training and education expenses, educational and research grants, and charitable donations, among others.
Companies must submit an annual report regarding interactions with U.S. physicians and teaching hospitals to the U.S. federal government, starting in 2014. The government will make this information available to the public annually through a searchable website that will be available by September 30, 2014. Beginning in 2015, the data will be published on June 30. For more
EndoShape is committed to acting with integrity in all of our interactions with physicians and other health care providers. We
value and look forward to continuing our essential collaboration with health care providers, which allows us to deliver innovative devices and procedures for the benefit of patients.
Some states, such as California, Massachusetts, and Vermont, have imposed limits on how medical device companies can interact with health care providers who are licensed to practice by these states. These state regulations will remain in effect alongside the U.S. Physician Payment Sunshine Act.
California requires device and pharmaceutical manufacturers to post a comprehensive compliance program and provide an annual declaration as to compliance.
Both Massachusetts and Vermont require pharmaceutical, biologic, and medical device manufacturers to submit an annual report detailing a wide variety of financial interactions with certain physicians and other health care providers licensed by those states. Similar to other pharmaceutical, biologic, and medical device manufacturers who do business in those jurisdictions, EndoShape may be required by law to report many types of direct and indirect payments and other transfers of value to physicians and other health care providers licensed by those jurisdictions. This generally includes the name of the contracting party, the purpose of the payment, the amount and nature of any payments made, and possibly other information about the payment. Massachusetts and Vermont also require pharmaceutical, biologic, and medical device manufacturers to comply with separate marketing codes of conduct, which regulate how employees of these companies can interact with health care providers licensed by these states.
For more information, please contact us.