Transparency in industry relations with collaborators such as healthcare professionals and healthcare institutions has been a pronounced and important compliance trend for several years.
Many companies voluntarily report the compensation of healthcare professionals for research, education, consulting, and product development. Transparency provisions have been imposed in government healthcare fraud settlements pursuant to deferred prosecution agreements (DPAs) and Health and Human Services (HHS) Office of Inspector General (OIG) corporate integrity agreements (CIAs).
The trend is a legal evolution as well where some states and now federal regulators have imposed reporting requirements for the purposes of revealing compensated relationships that may involve financial conflicts of interest and dissuading inappropriate interactions.
The transparency reporting provisions in the Patient Protection and Affordable Care Act (Affordable Care Act or ACA) and its implementing regulations in the Centers for Medicare & Medicaid Services's (CMS's) proposed rule, "Transparency Reports and Reporting of Physician Ownership or Investment Interests," apply broadly to the life sciences industry for transactions related to covered drugs, devices, biologicals, and medical supplies. The regulations will impact physicians and teaching hospitals, and will provide public access to substantial information on industry relationships with healthcare professionals and institutions. The mechanics of reporting the required information will necessitate vigilant attention to and tracking of corporate and affiliated expenditures to ensure compliance with the regulations. The Morgan Lewis Transparency Compliance Resource Center monitors state and federal transparency developments.
Transparency reporting and compliance obligations do not apply exclusively to life sciences industry collaborators. The ACA adopted broad reporting requirements that are applicable to hospitals, physicians, nursing homes, pharmacy benefit managers, and group purchasing organizations. A summary of these industry tracking, collection, and reporting provisions is available. Our Morgan Lewis Transparency Compliance team will post updates regarding health industry transparency compliance, regulations, and industry codes of ethics. If you have questions, please contact our Transparency Compliance Resource Center at TransparencyCompliance@morganlewis.com.
Final U.S. Sunshine Rule Issued Today (02/01/2013)
The Morgan Lewis Transparency team will issue a briefing on the final regulation shortly and will hold a free webinar on the provisions and implementation issues in the near future.