The burden of collecting and reporting data will be on the industry side, but physicians are encouraged to keep their own records and they will have 45 days to review disclosures and seek corrections if they dispute what is being reported about them. The CMS is encouraging doctors and companies to settle disputes by themselves and said it would not mediate disagreements but will note if a figure is being disputed.
“Dispute rate will be something that matters to us,” Dr. Shantanu Agrawal, director of the CMS Data Sharing and Partnership Group, said at last month's meeting of the American Medical Association House of Delegates. “This could become a trigger for an audit.”
Along with payments, manufacturers and GPOs are required to report ownership interests in their company by physicians and by physicians' immediate family members.
The CMS is holding a national provider call on Aug. 8, one week into the program. Doctors of medicine, osteopathy, chiropractic medicine, dentistry, dental surgery, optometry and podiatry are encouraged to participate and have their questions answered.
The AMA also has a section of its website devoted to the Sunshine Act, and it gives advice on what to say to patients who are curious about their doctor's industry relationship.
“When a patient asks about this topic, it is important that you discuss the matter candidly in a way that will enhance the patient's understanding without compromising trust or the patient-physician relationship,” the AMA recommended. “Some of the issues you might want to address with the patient are what sources you rely on for information about medical innovations and new evidence, your role in medical research, and how you believe research will improve outcomes for patients.”
The American Academy of Orthopaedic Surgeons has a similar statement on its website.
“Orthopaedic surgeons who have relationships with medical device or pharmaceutical companies should carefully study the Sunshine Act's implementing regulations to understand their impact on day-to-day activities as well as on perceptions of patients, the media, enforcement authorities and the public,” the AAOS advised its members.
The Sunshine Act was originally sponsored by Sen. Chuck Grassley (R-Iowa) and former Sen. Herb Kohl (D-Wis.).
“The goal is to help inform consumers and patients in all medical fields about financial relationships between drugmakers and doctors, with uniform disclosure,” Grassley said back in April. “The public deserves a much better picture of the drug industry's financial presence in medicine than it has today.”
“We strongly urge physicians to make sure all of their financial and conflict of interest disclosures, as well as their information in the national provider identifier database, are current and regularly updated,” Dr. Ardis Dee Hoven, AMA president, said in a news release. “We also urge physicians to ask industry representatives with whom they interact to provide an opportunity to review and, if necessary, correct all information they will report before it is submitted to the government.”