Early communication with pharmaceutical companies about the requirements of the Physician Payment Sunshine Act and better education on its provisions will prevent data disputes and reduce reporting surprises for doctors.
"A lot of physicians don’t realize how broad [the law] is," Stefanie A. Doebler, special counsel for Covington & Burling health care and food and drug practice groups in Washington, said in an interview. "Virtually everything [doctors] get from a manufacturer going forward is going to be reported. They need to be aware. They need to ask questions."
Stefanie A. Doebler
The federal Sunshine Act, adopted as part of the Affordable Care Act, requires manufacturers of drugs, devices, and biologics who participate in federal health care programs to report payments and items of value provided to physicians and teaching hospitals. The information must be made publicly available on a searchable federal database starting in September.
The federal government now calls the program Open Payments.
A 45-day review and dispute period for physicians began July 14. During this period, doctors can register with the Centers for Medicaid & Medicare Services’s Enterprise Portal, review data reported about them, and, if desired, initiate disputes with applicable manufacturers. Drug and device makers will then have an additional 15 days from then – ending Sept. 11 – to submit updated information to CMS.
Physicians need to make time to register and review their information now, Ms. Doebler said in an interview.
"They really need to be on top of reviewing their data," she said. "It’s kind of a pain in the neck for doctors, but they want to review it now and not once it goes public. Once it goes public, it’s there until the data is refreshed 6 months from now. They want to catch it now."
Physicians appear to be unclear on some areas of the law, Robert Ciolek, senior corporate counsel for Bristol-Myers Squibb, said during an American Bar Association webinar. For example, confusion often surfaces about whether the cost of lunches provided during educational programs are reportable.
"Frequently, the best opportunity [manufacturers] have is to do a lunch program where they can sit with a hospital staff and put together an educational program that talks either about a disease area or about a manufacturer’s product," Mr. Ciolek said. "The issue that always arises is, ‘What about the meal? Is it going to be reportable?’ We’ve seen time and time again, where doctors simply don’t understand the rule."
Carolyn M. Bruguera
If a doctor consumes a meal in such a setting, the cost of the physician’s meal is reportable, Mr. Ciolek said. However, the cost of meals provided to office staff or other health care team members is not reportable. If physicians do not want their lunch costs reported, but still want to attend the program, they should not eat the meal, he said.
Open Payments requirements should be discussed by companies and physicians and/or noted before or at the time of transfers of value, said Carolyn M. Bruguera, vice president of consulting services and general counsel for R-Squared Services & Solutions, a consulting and software firm.
For instance, language regarding the law should be included in contracts, referenced on sign-in sheets for group meals, or stated orally during meetings.
Many large manufacturers and industry trade groups have developed websites and brochures to help educate physicians about reporting obligations, she added.
"These are also good tools for avoiding disputes and misunderstandings, but in some cases, manufacturers may need to be more proactive about getting the information to the covered recipients," she said. "Greater coordination with, for example, physician groups, such as specialty societies, might be helpful in this regard."
Another crucial step for doctors is explaining to patients their relationships with pharmaceutical companies and device manufacturers and ensuring patients understand why these interactions are useful, Ms. Doebler said. Once the value transfers go public, some mainstream media likely will paint all transfers of value among companies and doctors in a negative light, she said.
"It’s incumbent on doctors to explain to patients that there are valuable reasons" behind transactions with companies, she said. "It’s helpful for physicians to be able to explain why these relationships are important."
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