Federal health officials have finally released the details on how online public reporting of industry payments to physicians will work.
Under the final rule released on Feb. 1 by the Centers for Medicare and Medicaid Services (CMS), drug, device, and medical supply manufacturers who participate in Medicare, Medicaid, or the Children’s Health Insurance Program will be required to submit annual reports to the federal government on any payments of $10 or more that they made to physicians and teaching hospitals. They also will be required to report on all payments if the payments and transfers of value to a single physician reach $100 in aggregate value for a year.
Manufacturers and group purchasing organizations (GPOs) must also report on physician ownership and investment interests each year. CMS will post the information on a public website. The requirements are mandated under the Affordable Care Act (ACA).
Dr. Daniel Carlat
"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," Dr. Peter Budetti, CMS deputy administrator for Program Integrity, said in a statement. "Disclosure of these relationships allows patients to have more informed discussions with their doctors."
Manufacturers and GPOs have until Aug. 1 to begin collecting data. They must submit their reports on payments made in 2013 by March 31, 2014. CMS will post the data online by Sept. 30, 2014.
CMS did not meet the deadline set by law for issuing this final regulation: Under the ACA, data collection was supposed to begin in January 2012.
The final rule contains plenty of exceptions, however. For instance, reporting is not required for gifts between individuals with an existing personal relationship. Other exclusions include small payments of less than $10, educational materials that directly benefit patients or are intended for patient use, discounts for rebates for drugs and devices, in-kind items for charity care, and samples.
Indirect payments made to speakers at accredited or certified continuing medical education (CME) events also do not need to be reported as long as the manufacturer doesn’t suggest speakers.
The final rule also clarifies that companies sponsoring large-scale conferences do not need to track and report on small gifts and food items worth less than $10 such as pens and bottles of water. These items also won’t count toward the minimum yearly reporting threshold of $100, according to CMS.
"I think this will make life easier, because it will contribute toward a more relaxed atmosphere at meetings so that attendees won’t have to worry every time they pick up a bottle of water or a granola bar," said Dr. Daniel Carlat, project director for the Pew Prescription Project, which works for greater transparency in physician-industry relationships.
Dr. Carlat said the final rule strikes the right balance between increasing payment transparency and not overburdening physicians with the requirements.
Although the data collection and reporting requirements are on the drug and device industry, physicians are responsible for reviewing their information before publication. Under the final rule, physicians will have 45 days to review the reports and another 15 days to work with the manufacturers to correct any disputed reports. After that, if there are still disputes, the information will be posted publicly but will include a disclaimer that it is disputed, according to the final rule.
The new transparency initiative will likely enhance the public’s trust and confidence in their physicians, Dr. Carlat said. Consumers often hear about the worst-case scenarios, where physicians are taking millions of dollars that may cause conflicts of interest, but the new reporting is likely to show that is rare, he said.
"I think we’ll find with these transparency reports that the vast majority of payments and gifts are of very low value and are the equivalent of $50 to $100 or a few hundred dollars a year," Dr. Carlat said. "I think when patients see these figures, their concerns about relationships between doctors and companies will be to some extent allayed."