PriMed recently submitted comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.
Pri-Med is a leading source of CME and clinical information for a community of over 250,000 health care clinicians, the majority of whom are physicians, across the United States. pmiCME/Pri-Med delivers a network of conferences and digital, multimedia content and online tools designed to help narrow gaps between research and practice and advance the health and health outcomes of patients and communities.
Comments on Sunshine Act
PriMed urged CMS to modify the proposed rules to exclude those that require applicable manufacturers to record and report payments that have been independently made by accredited continuing medical education (CME) providers to covered recipients who serve as faculty or contributors when that CME provider is using grant support provided by the applicable manufacturer. Pried also strongly urged that the proposed rules by CMS completely exclude educational materials provided by accredited CME providers to covered recipients from the reporting provisions as CME activities, are, by definition, conducted for the “direct benefit of patients”. These educational materials include both CME and non-CME materials that are produced by an accredited CME provider that is completely independent from any supporting covered manufacturer.
PriMed asserted that the proposed rules go beyond the intent of Congress and that the legislation does not include public reporting requirements of transactions related to the provision of CME when such payments are made from covered manufacturers to accredited CME providers. Accredited CME providers are not covered recipients under PPACA. In addition, to be in compliance with the requirements of the ACCME, accredited CME providers can never be in the position to provide direct or indirect payments on behalf of a covered manufacturer.
They noted how, “providers must act and implement their activities completely independently of any funder and this means that, by definition, the covered manufacturer cannot in anyway direct or influence any activity or action by an accredited provider, including what payment to make to any faculty. Thus, payments made by an accredited provider can never fulfill the definition of a “direct payment” or payment made by a “third party” at the direction of a covered manufacturer.”
PriMed emphasized how the ACCME requirements are clear: there can be no involvement of the covered manufacturer beyond providing grant support, which is only made to the accredited provider upon their action of submitting a request for funding to a covered manufacturer. As a result, they noted that the proposed rules will result in payments made by accredited CME providers being reported in ways that mirror reporting of payments that are actually under the direct control of the covered manufacturers. As a consequence, the credibility of accredited CME providers will be irreversibly diminished.
If the proposed rules are codified, PriMed noted that a payment by accredited providers to faculty or participants who are covered recipients will inaccurately be reported as a payment from the covered manufacturer and attributed to a specific drug, device or service of that covered manufacturer, even though such reporting violates the terms under which accredited providers could have accepted such funding from the covered manufacturer.
Further, they added that, “The reporting will be erroneous because the covered manufacturer, in fact, never made such a payment to a covered recipient.” Importantly, the proposed rules will undermine the very independence that accredited CME providers must operate within in order to be in compliance with the requirements of the ACCME.
They also noted how the proposed rules will create reporting burdens on accredited CME providers, many of whom are not staffed and/or resourced sufficiently to meet these requirements. This will also create reporting relationships between CME providers and covered manufacturers that will result in misleading and erroneous information being communicated to the medical community, patients and consumers.
Overall, pmiCME/Pri-Med said it was very concerned that the proposed rules will be detrimental, in both the short and long term, to accredited CME providers, the faculty they work with, the healthcare practitioners who they serve, the healthcare system they support and the patients whose healthcare they are committed to improving through education.
PriMed Survey
Following the announcement of the proposed rules, PriMed polled their faculty members (i.e. covered recipients) asking them if they were in favor of or opposed to the proposed regulations. Over 188 responded, most within 48 hours after receiving the survey. The feedback that they provided revealed significant insights:
- 88% believe that classifying CME as a direct payment as stated in the rules will lead to misrepresentation and misinformation of the relationship between commercial supporters and faculty.
- Nearly half the respondents (45%) said they were would not be willing to serve as faculty or contribute to the development of content in any grant-funded CME activities if the HHS’ proposed rules on reporting of physician payments from industry are enforced.
Overall, the faculty (through open ended comments) expressed deep concern about the ruling and the impact that such a decline in faculty participation would have on patient care and health care quality. They recognized CME as a bridge to health care professional community and patient care, and believe that today’s complex health care environment requires physicians to be even more in tune to the latest advances in science and medicine. Faculty expressed three main concerns:
- Concern #1: The regulations will create a financial relationship between the applicable manufacturer and faculty, who is a covered recipient, by reporting a direct payment relationship under the direction of the manufacturer, when the payment was not received from that manufacturer
- Concern #2: Reluctance to serve as faculty because the reporting requirements would result in incorrect perception that they are receiving a direct benefit from industry
- Concern #3: Negative impact such requirements would have on the quality and overall availability of CME and interaction with expert faculty, and ultimately patient care
Ultimately, to meet the demands ahead, PriMed noted that the clinician community needs more, not fewer, opportunities for CME across the continuum of live, online and mobile formats that is easily accessible in order to bring the best care to those who need it. Therefore, they recommended exempting payments to accredited CME providers from reporting.