Does Sunshine Act apply to Europe?
In the E.U., adoption of Sunshine Act-type legislation is growing, even as the industry has ramped up country-specific as well as Eurozone-wide self-regulation, such as the EFPIA Code of Practice (formerly “Disclosure Code”) developed by the European Federation of Pharmaceutical Industries and Associations.
Who must comply with the Sunshine Act?
The Sunshine Act requires that drug companies and makers of medical devices and supplies covered by the three big federal healthcare programs—Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP)—document and track all financial relationships with physicians and teaching hospitals.
What Efpia reporting?
The EFPIA Disclosure Code is a code of conduct that requires all EFPIA member companies and companies that are members of EFPIA member associations to disclose transfers of value to HCPs and healthcare organisations (HCOs).
Who are covered entities under Sunshine Act?
COVERED ENTITIES The Sunshine Act applies to manufacturers that operate in the United States and are engaged in the production, sale, or distribution of a covered drug, device, biologic, or medical supply.
How does the Sunshine Act work?
The National Physician Payment Transparency Program (Open Payments), a.k.a. Sunshine Act, is a section of the Patient Protection and Affordable Care Act of 2010 that requires pharmaceutical and medical device companies to report to the federal government certain payments and other transfers of value that they make to …
What is considered a health professional?
Healthcare Professional means a medical practitioner, dental practitioner, pharmacist, clinical psychologist, nurse, midwife, medical assistant, physiotherapist, occupational therapist and other allied healthcare professionals and any other person involved in the giving of medical, health, dental, pharmaceutical and …
Who is reportable under Sunshine Act?
The Physician Payments Sunshine Act (42 U.S.C. & 1320a -7b) requires manufacturers of drugs, medical devices, biologics, and medical supplies and group purchasing organizations (GPOs) to report to the CMS services payments made and investment interests given to physicians and teaching hospitals.
What does the Sunshine Act do?
What does the Sunshine Act prohibit?
Under the Sunshine Act, meals provided to nurses and office staff will not be reportable and will not be attributed to physicians. However, some state marketing disclosure laws require disclosure of payments to a broader group of recipients, including non-physician prescribers, nurses and office staff.
What does the Sunshine Act cover?
A: The Sunshine Act covers various forms of payment, including cash or cash equivalent; in-kind items or services; stocks, stock options, or other ownership interest; as well as dividends, profits, or other returns on investments.
What is the EU Sunshine Act guide?
The purpose of this guide is to identify EU countries that have implemented a Sunshine Act or sunshine rules and to provide a brief overview of these regulations.
What does the US Sunshine Act mean for physicians in Europe?
Since the enactment of the Physician Payments Sunshine Act (US Sunshine Act) by the United States, a number of EU Member States have adopted similar rules or strengthened pre-existing regulation in order to improve the transparency of relationships between physicians and health care companies.
What is the Sunshine Act and why does it matter?
The Sunshine Act requires that detailed information about payments and other “transfers of value” worth over $10 from manufacturers of drugs, medical devices and biologics to physicians and teaching hospitals be made available to the public.
What is the physician payments Sunshine Act (PPA)?
The CMS rule, “Transparency Reports and Reporting of Physician Ownership or Investment Interests” also known as the Physician Payments Sunshine Act, requires applicable manufacturers of drugs, devices, biologicals, or medical supplies to annually report to CMS certain payments or transfers of value made to physicians or teaching hospitals.