As you know, in August 2011 we issued a final rule in the Federal Register revising the regulations on financial conflicts of interest (FCOI) of extramural investigators, and these regulations were implemented in August 2012. One of the major changes in the new regulations was the requirement that institutions make publicly accessible certain information concerning identified financial conflicts of interest held by senior/key personnel. This requirement was included to help the public monitor the integrity of the research funded by the Department of Health and Human Services (HHS) and to underscore our commitment to fostering transparency and accountability.
This public accessibility requirement in the FCOI regulations is in line with a number of recent public disclosure initiatives. One such example is the “Sunshine Rule”, which was included in the Affordable Care Act passed in March 2010. Today, a final rule implementing the Sunshine Rule provisions was posted in the Federal Register by the Centers for Medicare & Medicaid Services (CMS).
The rule, called the “National Physician Payment Transparency Program: Open Payments”, finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) to report payments or other transfers of value they make to physicians and teaching hospitals to CMS. CMS will post that data to a public website. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests. Applicable manufacturers and applicable group purchasing organizations must begin to collect the required data on August 1, 2013 and report to CMS by March 31, 2014. The final rule contains a lot more information on reporting these payments or other transfers of value and their subsequent publication on the website.
There are some major differences between these two rules. For example, the FCOI regulations cover financial interests of investigators receiving or applying for funding from the Public Health Service including the NIH, while the new CMS rule covers payments from the entities listed above to physicians and teaching hospitals. As I’ve shown before, around 30% of NIH-funded principal investigators have an MD or MD/PhD degree. Therefore, some individuals may be covered by both rules.
It is extremely important that we all strive to maintain the public trust in biomedical research and its applications. The National Physician Payment Transparency Program is part of this evolving landscape.