Starting on August 1, 2013 drug, device, biological and medical supply manufacturers covered under federal programs (i.e., Medicare, Medicaid or the Children’s Health Insurance Program) must begin to collect and report to the government payments or transfers of value they make to physicians and teaching hospitals. The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), will then make the information available online for review by the public. The data will be posted online by September 30, 2014. This reporting is required under the National Physician Payment Transparency Program: Open Payments, also known as the Sunshine Act, one of the items included in the Affordable Care Act (ACA) designed to “create greater transparency in the health care market.”
Transfers of value include consulting and speaking fees, meals, travel, gifts and research activities. In regard to research activity, the proposed rule provides special considerations. The final rule outlines procedures to ensure that the nature of the relationship between physicians, teaching hospitals and manufacturers (essential to the development of new products) and outlines a means by which sufficient data is reported to inform the public of the relationship without compromising competitive interests. The statute allows HHS to delay publication of certain research payments until a) U.S. Food and Drug Administration (FDA) approval of the product or b) four years after the payment data, whichever is earlier. Additionally, the rule provides a reporting exemption for payments to doctors serving as speakers at accredited or certified continuing medical education programs. In order to qualify for the exemption, the following conditions must be met: The program must be certified or accredited by the Accreditation Council for Continuing Medical Education (ACCME), American Osteopathic Association (AOA), American Medical Association (AMA), American Academy of Family Physicians (AAFP) or American Dental Association (ADA) Continuing Education Recognition Program; the manufacturer does not select the covered speaker or provide the third-party vendor with a distinct, identifiable set of individuals to be considered as speakers for the program; and the manufacturer does not directly pay the covered speaker.
Manufacturers and group purchasing organizations (GPOs) are required to disclose to CMS physician investment or ownership interests. GPOs will have until March 31, 2014 to report data for August 2013 through December 2013. Violators of the reporting requirements (i.e., manufacturers) will be subject to civil monetary penalties capped at $150,000 for failure to report and $1 million for knowing failure to report.
CMS released the final rule on Friday, February 1, 2013, and regulations will be printed in the Federal Register on February 8, 2013.
The AUA will be developing guidance for our members to navigate this new set of regulations, and will continue to keep you informed on this issue as the reporting date nears. Watch the Health Policy Brief, AUAnet.org and other AUA publications for additional information.