CMS Issues Sunshine Rule
By Joyce Frieden, News Editor, MedPage Today
Published: February 01, 2013
The Centers for Medicare and Medicaid Services issued a long-awaited rule Friday finalizing the details for a database that will list payments made to physicians by pharmaceutical and device manufacturers.
"You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need," Peter Budetti, MD, the agency’s deputy administrator for program integrity, said in a statement. "Disclosure of these relationships allows patients to have more informed discussions with their doctors."
The rule, a provision of the Affordable Care Act known as the Physician Payments Sunshine Act, "finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value they make to physicians and teaching hospitals to CMS," the statement explained. "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."
Data collection will start on Aug. 1, CMS said, noting that "Applicable manufacturers and applicable GPOs will report the data for August through December of 2013 to CMS by March 31, 2014 and CMS will release the data on a public website by Sept. 30, 2014. CMS is developing an electronic system to facilitate the reporting process."
The rule "is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers," the statement continued.
1.The event meets the accreditation or certification requirements and standards of the Accreditation Council for Continuing Medical Education, the American Dental Association’s Continuing Education Recognition Program, the American Academy of Family Physicians, the American Medical Association, or the American Osteopathic Association
2.The drug or device company doesn’t directly pay the speaker
3.The drug or device company doesn’t select speakers for the event or "provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program"
"We believe this reporting strategy appropriately separates accredited and certified continuing education from unaccredited and noncertified continuing education, so that consumers can better understand the nature of the payment received by a covered recipient," the agency noted in the rule. "We also believe that educational speaking engagements should be separated from all other speaking engagements, promotional or otherwise."
The American Medical Association responded cautiously to the release of the final rule. "The AMA will carefully review the new Physician Payment Sunshine Act rule," AMA President Jeremy Lazarus, MD, said in a statement. "Physicians’ relationships with the pharmaceutical industry should be transparent and focused on benefits to patients … As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process."
Others were more effusive. "This rule allows a long-delayed transparency measure to take effect," Allan Coukell, director of medical programs at The Pew Charitable Trusts, said in a statement. "Public reporting of the financial relationships between doctors and drug or medical device companies will protect patients and help restore trust in our healthcare system. We applaud the Centers for Medicare and Medicaid Services for issuing the Sunshine regulation, which will now allow manufacturers to comply with their reporting obligations under the law."
The CMS action comes after complaints by physicians and others that the agency was taking too long to issue the rule.
"We applauded its passage but, nearly 3 years later, we are disappointed that the [Sunshine Act] has yet to be implemented — especially in light of reports that the final rules are being held up at the White House Office of Management and Budget," a group of prominent physicians, including former New England Journal of Medicine editors Marcia Angell, MD, and Jerome Kassirer, MD, wrote in a January letter to outgoing White House Chief of Staff Jack Lew.
"Financial relationships between physicians and drug and medical device companies can create conflicts of interest that threaten the quality of patient care and drive up healthcare costs," the letter continued. "As our nation struggles with these problems, it is imperative that the administration implement the [Sunshine Act] without any further delay."
The rule is scheduled for publication in the Federal Register on Feb. 8.