According to a new article published in Law360, the CME Coalition has the led a deluge of over 500 comments to the Centers for Medicare and Medicaid Services (CMS) protesting proposed changes to the Sunshine Act's exemption for accredited CME. "CMS is facing heavy pressure from doctors to modify its plan to subject the financial support by drug and device makers of continuing medical education to disclosure under the Physician Payments Sunshine Act," the article states. "Nearly 500 physicians have signed and sent form letters drafted by the CME Coalition trade group expressing concern about changes that CMS proposed in July, according to correspondence published in the Federal Register in recent days and weeks." The CME Coalition has been encouraging stakeholders - including individual practitioners, CME providers, and organizations - to engage in the democratic process and express their opinions on the proposed rule. Among these efforts, the CME Coalition has developed an online 'Action Center' that allows people to easily submit comments. The deadline to comment is Tuesday, September 2 at 5:00 pm.
CMS Gets Heat On Elimination Of Sunshine Act Exemption
By Jeff Overley
Law360, New York (August 28, 2014, 4:55 PM ET) -- The Centers for Medicare and Medicaid Services is facing heavy pressure from doctors to modify its plan to subject the financial support by drug and device makers of continuing medical education to disclosure under the Physician Payments Sunshine Act, records show.
Nearly 500 physicians have signed and sent form letters drafted by the CME Coalition trade group expressing concern about changes that CMS proposed in July, according to correspondence published in the Federal Register in recent days and weeks.
Also, scores of medical societies have fired off letters criticizing the proposal, saying it would badly undermine respected educational events and thereby harm public health.
“Attendees may be less willing to participate in those programs — even if the industry support for the program was completely independent and conflict-free — if they believe their identity and attendance may become known to the commercial supporters and the value of the CME may thus be reported against them,” the American Academy of Family Physicians, an accredited continuing medical education organization, wrote in a letter earlier this month.
Under the July proposal, continuing medical education would still be eligible for an exemption from the Sunshine Act, also known as Open Payments, under a section that applies to indirect payments — for example, money from a drugmaker that goes to a CME group and later finds its way to doctors. That section says payments need not be reported if the entity making a payment is unaware of which doctors receive it and remains unaware for the first six months of the year after it is made.
However, many stakeholders say that manufacturers will never be able to meet that standard because they will inevitably learn the identities of speakers when attending events that they sponsor.
“Because CME presenters are always publicly listed, as a practical matter, speaker payments will have to be reported as a general rule,” the CME coalition wrote in a recent letter.
Under a proposal from the coalition, the CME exemption would remain intact, but an additional safeguard would be added to prohibit manufacturers from “influencing” the selection of speakers at events they sponsor.
That proposal may not fully satisfy regulators, however, because they expressed separate concerns about how to decide in an evenhanded manner which providers of CME have accreditation standards that are strong enough to deserve the exemption.
The American Medical Association, in recent letter joined by more than 100 other health care societies, is putting forward a different proposal. It would alter the exemption for indirect payments so that it applies when manufacturers don’t know before committing to sponsorships who will speak at a CME event, even if they become aware after agreeing to provide financial support.
“This accomplishes CMS’ goal while eliminating the potential for negatively impacting [CME],” the association wrote.
A CMS spokeswoman didn’t immediately respond to a request for comment Thursday on whether the proposed policy may be modified. The deadline for comments on the plan is Tuesday.
Separately Thursday, CMS announced that the Open Payments system will be temporarily unavailable during scheduled maintenance on Saturday and on Sept. 5. To account for those outages, the agency extended a 45-day payment verification period to Sept. 10 from Sept. 8 and a 15-day correction period to Sept. 25 from Sept. 23.
The AMA, which has urged CMS to delay the database's Sept. 30 launch, immediately seized on news of the outages, declaring in a statement that "it is clear that the government’s website is not ready for prime time."