1 CME COALITION:A CALL TO ACTIONRESPONSE TO THE PROPOSEDRULE ON THE SUNSHINE ACT
Background 2 On December 19, HHS issued a proposed rule for the Physician Payment Sunshine Act. The Act’s stated intent is to shed light on direct payments from product manufacturers to physicians and other medical practitioners. As drafted, the Act protected CME by excluding coverage of indirect payments to “covered recipients” by “applicable manufacturers,” such as industry contributions to continuing education programs or presentations.
The Proposed Rule 3 Unexpectedly, HHS declared in the rule that it would rely upon a “catch-all” provision in the Act to require additional reporting, including from CME providers, professional medical associations, patient advocacy groups and other non-profit organizations. These organizations may now become responsible for reporting all payments to covered recipients. This would create a significant new reporting burden on CME providers and supporters that is neither good public policy nor consistent with the intent of Congress. It will be close to impossible for any CME provider to accurately track every dollar provided by a CME supporting entity who helps underwrite a given CME program.
Proposed Rule and Third Parties 4 CMS proposed that Direct compensation for serving as faculty or as a speaker for a “Medical Education Program” be interpreted broadly to encompass all instances in which applicable manufacturers pay physicians to serve as speakers and not just those situations involving “medical education programs.” (page 33) HHS did not differentiate between accredited CME and other speaking engagements Finally, third party payments might have to be reported if funds are made available “at the request of or designated on behalf of” a teaching hospital or physician. (page 16, 19, 20…)
Proposed Rule and Third Parties 5 Act generally excluded payments to third parties If manufacturer is unaware of recipient’s identity However If manufacturer is aware of identity they must report Broad standard for “awareness” Actual knowledge or acts in deliberate ignorance/reckless disregard of identity of covered recipient “Publicly Available” Example Dept chair = publicly available must be reported (page 38-39)
Certified CME Is Different 6 Highly regulated ACCME, FDA, OIG, AMA, AdvaMed, PhRMA…. Independent Companies have no input on faculty or attendees Meaningful disclosure and resolution All speakers required to disclose commercial interests Resolution of conflicts of interest required Free from commercial bias Separate grant making function Serious penalties and consequences Including loss of accreditation
Impact on CME Providers 7 Tracking all “payments” or “transfers of value” Faculty (honorarium, food, travel, incidentals, MPI numbers…..) Attendees if list is published or available (department meetings, annual meetings) Checking the data prior to submission, and after publication Submissions of amendments May contact faculty or attendees with report of what you reported Reduced access to faculty? Decreased attendance? Significant additional administrative burden
Impact on CME Supporters 8 Probably will require additional paperwork from CE providers Reputational risk (did CE Provider engage faculty we did not want associated with our company) Will paperwork from CE providers get back to us on timely basis (small providers…with little infrastructure) Diverts funds from education towards administration Changes grant request process Have to track a lot of other payment information
CME Scenarios 9 CE support Commercial Support for Meeting Exhibit Booth Rentals Other Support/Sponsorships Multiple supporters Meetings with multiple faculty and multiple supporters and type of support Reporting – will be required of CE provider by supporter to meet sunshine requirements Reporting all payments to organization – distribution to all covered entities (physician and teaching hospitals)
Key Questions 10 What is the meaning of “Awareness?” The financial impact of reporting on CE providers not included in the proposed rule? Must delineate between accredited and non accredited activities? Timing issues for CE providers and supporters? Other parts of the rule may affect CE? Educational Materials that Benefit Patients? Does outcomes research fall under research or education?
Public Reaction 11 The public reaction to the proposed rule has been consistent in its interpretation, with “transparency advocates” claiming victory for the unexpected closing of a “loophole” they thought ran counter to the Act’s broader intent. “The proposed rules mean that industry will have to disclose all payments when it is “aware of the identity” of the recipient.” – Forbes.com blogger “Drug companies will, in fact, be required to report payments that flow through third party entities and end up in doctors’ pockets, as long as the company is aware of the identity of the doctor. And how could they not be aware?” – Dr. Dan Carlat
Next Steps 12 CME Coalition is launching an aggressive campaign to roll back the proposed rule, including the following steps: Draft comments for submission to HHS on behalf of CME Coalition (Due February 17) Meetings with HHS officials to share our concerns for the rule. Meetings with select members of Congress and their staff to lodge our concerns and seek their engagement with HHS on this issue. Host Group Leadership strategy call (January 9) Nationwide grassroots call of CME supporters to explain the implications of the rule and encourage participation via congressional advocacy and direct commenting to HHS (January 11) Briefing on the Sunshine Act proposed rules at the Alliance for CME Annual Conference in Orlando. (January 23)
Call to Action 13 If this proposed rule is to be challenged before the final rules are implemented in 2013, the CME community must work together and speak with one voice to provide a strong and effective rebuttal to decision makers in Washington. We urge you to consider doing three things: Submit comments on the proposed rule to HHS before their February 17 deadline. Reach out to your congressional delegation to explain the potential impact of this rule on CME and your organization. Join the CME Coalition!
Why Join the CME Coalition? 14 Participation in all Steering Committee decisions related to the priorities, direction and activity of the Coalition. Participation in bi-weekly Steering Committee calls with the Coalition’s Washington-based consultants. Analysis of important health care policy and access to a weekly written health policy update. Access to key informational material about regulatory and legislative policies impacting CME. Real-time updates and action alerts about important issues such as congressional hearings and legislation. Unfettered and unrestricted access to analysis, advice and information from the Coalition’s Washington-based health policy government relations firm, Thorn Run Partners.
Thank you 15Chris Lamond, Executive Director firstname.lastname@example.org (202) 688-0222Andrew Rosenberg, Senior Strategist (202) 247-6301 email@example.comCME Coalitionwww.cmecoalition.org