CMS warms to some stakeholders, burns others with Sunshine rule
With the dust beginning to settle on CMS's final rule for the Sunshine provisions of Obamacare, released Feb. 1, victors and suckers are starting to emerge from the fine print of the 287-page document.
Clinical Research Organizations. Instead of making them break down the value of a research grant to individual participants in a study, CMS decreed that companies need only report the total amount spent on research, followed by a listing of the doctors that participated in a clinical trial. “I thought it was elegant, the way they came up with a solution to that,” says Tom Sullivan of med ed firm Rockpointe and the Association of Clinical Researchers and Educators.
“We recognize that reporting payments or other transfers of value for research activities is extremely complicated,” the final rule reads, “since many research activities include large payment amounts which are spread across numerous activities and parties, and acknowledge that our proposed method did not fully address this complexity. We understand the need for a simple and clear reporting process, which allows the agency to accurately present research payments to consumers.”
“CMS really recognized a fundamental difference between research payments and other types of payments to physicians,” said John Lewis, head of public affairs for the Association of Clinical Research Organizations. “Research payments are going to be segregated and reported separately to the public, and we thought that was very important to ensure that research payments are not mischaracterized in some way. We had hoped research would be exempted completely, but we were really concerned that it would be a disincentive for physicians to participate in research, so that segregation is very important and we're pleased CMS went in that direction.”
CROs also stand to gain from the sheer sweep of the law's reporting requirements, which go back to the preclinical phase and mandate that companies keep their records for nine years.
Marketing research firms. The final rule includes an exemption for reporting of indirect payments where manufacturers are unaware of the identity of the recipient, as is common in marketing research.
“For purposes of this rule only,” says CMS, “we will not consider an applicable manufacturer to be acting in deliberate ignorance or reckless disregard of a covered recipient's identity in situations when the reason a payment or other transfer of value is being made through a third party is that the identity of the covered recipient remains anonymous. For example, an applicable manufacturer may hire a market research firm to conduct a double-blinded market research study, which includes paying physicians $50 for responding to a set of questions. The applicable manufacturer clearly intends a portion of the payment to be provided to physicians, but given that the reason for the third party's involvement is specifically to maintain the anonymity of the respondents and sponsor, we do not intend this to be considered a reportable indirect payment or other transfer of value.”
“We were pleased to see mention of that in the guidance,” said Howard Fienberg, director of government affairs at the Marketing Research Association. “They call out blinded marketing research payments specifically. Once we saw the legal language, that was fine, but the compliance people at manufacturers are very conservative, and unless it's specifically mentioned, they'd feel it's not legal.”
As with clinical research, the concern was that doctors might shy away from participating in studies if they knew their name would appear on a website in connection with industry funding.
"There would be very few doctors interested in participating in a study if they were going to be tagged as being under the influence of the sponsor,” said Fienberg. “It would have killed confidentiality in the research process in addition to killing the incentives for doctors to participate.”
The MRA was also delighted to see states with restrictive conflict-of-interest laws, like Minnesota, acknowledging that the law will preempt their own—though the law's preemption doesn't bar Vermont from banning payments to physicians.
Accredited CME providers. The law exempts reporting on indirect payments to speakers at accredited CME programs made through third parties. CMS said they “agree that industry support for accredited or certified continuing education is a unique relationship. The accrediting and certifying bodies, including ACCME, AOA, AMA, AAFP, and ADA CERP, and the industry standards for commercial support, create important and necessary safeguards prohibiting the involvement of the sponsor in the educational content.”
“The transparency component of the Sunshine Act aims to eliminate potential conflict of interest, and we wholeheartedly support that goal,” says Andy Rosenberg of the CME Coalition, “but the case we were making is that accredited CME is already subjected to very stringent rules, and layering the sunshine act reporting requirements on top of that would be duplicative, unnecessary and ultimately detrimental to the cause of educating physicians. And they agreed.”
Lawyers, for whom Marc Scheineson, who heads the food and drug law practice at Alston & Bird, calls it a “full employment act.”
“Its huge complexity and really comprehensive requirements will need to be reviewed by every pharmaceutical manufacturer that makes a grant now and in the future,” says Scheineson, noting that CMS has estimated that the law will cost $269 million to implement, along with another $180 million per year to administer. Accountants and data processors can expect a nice boost, too.
Promotional med ed providers. “With regard to unaccredited and non-certified education, we believe that since this type of education program does not require the same safeguards as an accredited and certified program, payments or transfers of value should be reported as required for any other payment or other transfer of value,” says CMS. That goes for FDA-mandated REMS education, too, when it's not accredited.
Medical societies and publishers (maybe): Under the law, textbooks are considered a gift when they're industry-sponsored and the recipients are known. Could the same be true for advertising-supported journals or physician social networks? Attendance at industry-sponsored meetings and conferences? That's not yet clear.
The restaurant and hotel industries. They'll be serving more buffets and fewer per-plate lunches at speaker events and conferences, thanks to an item in the law exempting reporting of expenses for meals where a cost-per-participant can't be determined.
“I think the big loser is the patient,” said John Kamp, executive director of the Coalition for Healthcare Communication. “When promotional education suddenly becomes a gift, physicians are going to attend fewer promotional med ed events. When you can't attend a REMS presentation without your name appearing on a list of physicians who've gotten gifts from industry, you're just going to know less about what the FDA said you should know more about. There will be less collaboration, and that's going to be bad.”