A new article in Inside Health Policy, a leading source for Washington policy experts, enumerated concerns on the Sunshine Act exemption for CME expressed in a Council of Medical Specialty Societies (CMSS) letter to the Centers for Medicare and Medicaid Services (CMS). The article notes that even though CMS states in the proposed rule’s preamble that it intends to maintain the exemption, “the provision of the sunshine law that CMS will use … will actually make indirect payments by drug and device manufacturers to CME events reportable.”
"It is not realistic, nor would it be perceived as transparent, if faculty names were hidden until the day of the program, nor would physicians attend such programs," CMSS writes in their letter. "As a result, over time during the planning process, even if the company does not request faculty names, companies providing commercial support to CME providers will potentially learn the names of the faculty, usually before the program, and certainly within two quarters after the program, through promotion of the program itself."
"It is not realistic, nor would it be perceived as transparent, if faculty names were hidden until the day of the program, nor would physicians attend such programs," CMSS writes in their letter. "As a result, over time during the planning process, even if the company does not request faculty names, companies providing commercial support to CME providers will potentially learn the names of the faculty, usually before the program, and certainly within two quarters after the program, through promotion of the program itself."
Reiterating concerns raised by other stakeholders, the Council of Medical Specialty Societies is asking CMS to keep in place the existing exclusion for accredited and certified continuing medical education (CME) under the Open Payments program (known as the sunshine law) because the agency's solution to a perceived problem with the exclusion is unworkable and would open the door to exclusions for purely commercial promotional events put on by drug and device manufacturers.
In its July 3 proposed physician payment rule, CMS says it wants to get rid of the CME exclusion in the Sunshine Act because it is redundant with another provision of the law. The proposed rule states that indirect payments from drug and device manufacturers to sponsor or underwrite CME events where the manufacturers have no control of the subject matter or speakers at the event would not have to be reported.
Stakeholders told CMS the exclusion amounted to an endorsement of five CME accreditation organizations -- the Accreditation Council for Continuing Medical Education; the American Academy of Family Physicians; the American Dental Association's Continuing Education Recognition Program; The American Medical Association; and the American Osteopathic Association -- because the agency excluded others that use the same or similar accreditation standards. This was something CMS had not intended, the agency said in the proposal, part of CMS' proposed physician pay rule.
In the proposed rule, CMS said the CME exclusion was redundant because of another provision that excludes indirect payments or transfers to medical professionals providing CME lectures as long as manufacturer are unaware of the lecturers' identities for essentially up to a year and a half after the indirect payment has been made.
In letter sent to CMS administrator Marilyn Tavenner Tuesday (Aug. 19) CMSS, which includes 41 member societies that represent 750,000 specialty physicians, noted that it was part of the negotiations when the CME exclusion was written and insisted that "the distinction must be made and maintained between accredited and certified CME, offered by accredited CME providers offering credit certified by the CME credit systems in medicine, contrasted with the promotional education of physicians, offered by companies."
"To eliminate the section specifically mentioning these groups and standards opens the door for unapproved standards that are not universally accepted, and for groups outside of these to set standards which are not part of the CME accreditation system in the US. Such action would undermine independent CME in the US," CMSS writes.
CMMS says it understands that CMS is trying to simplify the process and keep from having to add to the list of exempted CME providers, but accredited and certified CME providers, such as the ones listed in the CME exclusion, have long standing practices and safeguards against commercial influence by drug and device manufacturers. This is precisely why the five above mentioned organizations are specifically listed in the CME exclusion.
"The importance of maintaining the distinction between independent, accredited and certified CME and other types of promotional education to physicians cannot be overstated. To avoid the introduction of commercial influence into education which is not accredited and certified and therefore not adherent to the firewall created by the ACCME SCS, CMS must maintain the distinction between accredited and certified CME versus promotional education to physicians," CMMS writes.
Like the CME Coalition has stated and an industry lawyer told Inside Health Policy, CMSS says the provision of the sunshine law that CMS will use to essentially keep the intent of the CME exclusion intact if it is done away with will actually make indirect payments by drug and device manufacturers to CME events reportable.
In the proposed rule, CMS said the CME exclusion was redundant because of another provision that excludes indirect payments or transfers to medical professionals providing CME lectures as long as manufacturer are "unaware" of the lecturers' identities for essentially up to a year and a half after the indirect payment has been made.
CMSS says it is impossible for manufacturers not to know who the presenters will be because their names are published long before a CME event takes place, and often times are known to manufacturers already when CME organizations ask for sponsorships of a particular conference or symposium.
"It is not realistic, nor would it be perceived as transparent, if faculty names were hidden until the day of the program, nor would physicians attend such programs. As a result, over time during the planning process, even if the company does not request faculty names, companies providing commercial support to CME providers will potentially learn the names of the faculty, usually before the program, and certainly within two quarters after the program, through promotion of the program itself," CMSS writes.
CMSS, like the CME Coalition, also worries that that if CMS does away with the CME exclusion, educational materials given to attendees at lectures and events may also become reportable. CMSS notes that "CMS has always recognized that attendees have no relationship with companies which might choose to provide grants of commercial support to CME providers for accredited and certified CME."
An official with a leading CME stakeholders group told Inside Health Policy this reporting exclusion is detailed specifically in the CME exclusion and does not seem to be accounted for in the second Sunshine Act provision CMS says will now cover indirect payments if the CME exclusion is dropped. In proposing to do away with the CME exclusion as part of the physician pay rule, CMS does not make any mention of attendees and the materials they receive at CME events.
"I can't imagine CMS meant to get rid of that reporting exclusion, but they don't address it," the industry official says.
