This week, Pfizer, Inc. announced a change to its continuing education (CE) and continuing medical education (CME) policies in response to the Physician Payment Sunshine Act, which went into effect August 1st. The announcement came from Pfizer's Independent Grants for Learning & Change (IGL&C) department (formerly the Medical Education Group).
In addition, Pfizer held a webinar to go over the changes and to answer several questions. Policy & Medicine attended the webinar, and below is a summary of Pfizer's changes and its response to several questions. Pfizer said it will post the webinar recording as soon as possible.
Pfizer noted that the company will be posting resources to its website in the coming weeks to help CME/CE providers and referred listeners to the CME Coalition's Guidebook on the Sunshine Act.
Preliminarily, Pfizer acknowledge the three requirements set out by CMS that will exempt certain payments from being reportable or tracked:
- Accredited by the ACCME, AAFP, AMA, AOA (osteopath), or ADA
- No direct payment (as required by ACCME SCS 3.4-3.6; and
- No role in directing, suggesting, or implementing how the proceeds of grant are used by CME provider (which are mandated by ACCME SCS 3.2; 1.1(d), and 3.1)
Pfizer acknowledged that its own interpretations may be different from other companies who support CE/CME, which underscores the need for consistent guidelines and rules that all commercial supporters should follow to make the process easier for CME providers. The CME Coalition's Guidebook provides a great starting point for creating consensus among commercial supporters; however, companies may likely have divergent policies regarding Sunshine and CME.
Pfizer breaks its support of "educational activities" into three categories:
- Track 1: Request for Proposal (RFPs) programs;
- Track 2: Annual Meetings; and
Health Care Charitable Contributions
Pfizer announced that CE/CME providers can no longer use IGL&C grant funds for food or beverage in any capacity (all three activities noted above). Pfizer clarified that this includes funds for food and beverage at the actual CE/CME program and any planning or faculty events prior to the program.
Pfizer's new policy went into effect August 1st, 2013. During the Q&A session, Pfizer explained that if a CE/CME provider has already received a letter of agreement (LOA) and funds for the program prior to August 1st, there will be no reporting required.
However, if a CE/CME provider has not yet received funds or receives funds after August 1st, that provider should expect to receive an addendum to the LOA. That addendum will require the CE/CME provider to certify that no funds from the grant will be used to support food or beverage.
Further, Pfizer announced that it will be updating all LOA's to include this requirement, and all providers moving forward will have to certify that funds will not be used for food and beverage. Pfizer maintained that if it discovers funds are used for food or beverage, the company will require the CME provider to return such funds.
For Track 1-RFPs, Pfizer explained that it will require grant recipients to report back to IGL&C indirect transfers of value to faculty (planners, speakers, investigators, project leads, etc.) and participants where appropriate, at the grant reconciliation stage.
For multi-year projects, Pfizer will require an interim/annual report. Grant recipients will be notified of these reporting requirements at the time of grant approval.
All Health Care Charitable Contributions (unless accredited by one of the five (5) organizations listed above) will require reporting of faculty and attendees if they meet the definition of 'Covered Recipient.' Pfizer noted in its Q&A that at this time, it does not support satellite symposia.
Next, Pfizer announced that for all Track 2-Annual meetings, the provider must be accredited by one of the five recognized bodies and must offer credit. Pfizer clarified that credit must be offered during the Q&A session.
Pfizer explained that it intends to have a process in place by the end of 2013 to manage the reporting complexities of grants to institutions and organizations that are accredited by a body other than the five (5) listed above. Thus, Pfizer essentially announced that it will not be supporting activities other than those accredited by the five (5) entities recognized by CMS until it has this process in place—e.g., Nurse Practitioners, Pharmacists, PA's, Nurses, etc.
Pfizer said the application and reconciliation process will be updated to handle necessary reporting with minimal burden to provider and the process will take time to ensure all appropriate questions and safeguards are in place to handle reporting in line with the Sunshine Act.
In the Q&A, Pfizer made it clear that its new policy is to ensure that it will not have to report or track any information regarding speakers, faculty and physician-attendees at "Sunshine-exempt" CME/CE programs.
Pfizer noted that with respect to grant applications, it cannot provide any advice or guidance to providers on what to include in such RFPs (pursuant to ACCME Standards for Commercial Support), but the company will not support any program that includes a budget for food and beverage. Pfizer repeatedly made clear that no funds from a Pfizer grant may be used for food or beverage.
With respect to programs that Pfizer hosts with other companies, such as the BMS-Pfizer alliance, Pfizer stated that the rules of the "administrator" will apply—in this case, BMS.
Ultimately, Pfizer noted that in the coming weeks, IGL&C will begin to disseminate materials regarding processes, timelines and templates that grant recipients will be required to follow and use in reporting accurate data on payments and other transfers of value provided to covered recipients using Pfizer IGL&C education grant dollars.
In the weeks and months to come, manufacturers will likely diverge on their interpretations of the Sunshine Act. It will be critical for all CME/CE providers and stakeholders to closely analyze new policies from commercial supporters, particularly in LOAs and other RFPs that may impose additional reporting or tracking obligations or conditions for accepting funding.
Policy & Medicine will try to update readers with as many policies and updates from commercial supporters as possible and provide links/summaries when possible.