1 CME COALITION:A CALL TO ACTIONRESPONSE TO THE PROPOSEDRULE ON THE SUNSHINE ACT
Background In 2010, the Affordable Care Act was enacted with portions of the Physician Payment Sunshine Act. On December 19, HHS issued a proposed rule. The Act’s stated intent was 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 proposed 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 will 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.
What is at Stake? 4 Literally – we are facing the smothering of future industry support for continuing medical education. Currently, private industry is responsible for roughly one-third of CME, and this number is shrinking. CME providers, industry supporters, health care practitioners and patients all have much to lose from a further deterioration of CME funding. Ultimately, this is about patient outcomes.
Proposed Rule and Third Parties 5 CMS proposes 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 Third party payment reporting may be required 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 6 The Sunshine Act generally excluded payments to third parties… So long as the manufacturer is unaware of recipient’s identity However… If manufacturer is aware of the recipient’s identity it 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 7 It is highly regulated ACCME, FDA, OIG, AMA, AdvaMed, PhRMA…. Independent Supporters have no input on curriculum, faculty or attendees Meaningful disclosure and resolution All speakers are required to disclose any commercial interests Resolution of conflicts of interest required Free from commercial bias Separate grant-making function Serious penalties and consequences exist for violations Including loss of accreditation
Impact on CME Providers 8 Required tracking of all “payments” or “transfers of value” Faculty (honoraria, 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 Submission 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 9 Requires significant additional recordkeeping for CE providers and supporters Reputational risk For industry supporters For program presenters For attendees Will CE providers be able to process the recordkeeping required by industry supporters on a timely basis? Necessitates tracking a lot of other payment information Diverts funds from education towards administration Changes grant request processes
CME Scenarios 10 CE support Commercial Support for Meeting Exhibit Booth Rentals Other Support/Sponsorships Multiple supporter events Meetings with multiple faculty, multiple supporters and varying types 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 11 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 12 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 13 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. Hosted Group Leadership strategy call (January 9) Hosted 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) Today’s briefing on the Sunshine Act proposed rules at the Alliance for CME Annual Conference in Orlando. (January 23)
Call to Action 14 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? 15 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.
CME Coalition Highlights - The First 6 Months 16 Official Launch: June 1 (website-press) Comments to ACCME on corporate logos Presentations: ACRE, CBI, ACME House/Senate Policy Briefings Outreach and letters to AMA re: CEJA CME Report Code of Conduct Active media outreach Congressional letters endorsing S. 1700 Med Device Regulatory Improvement Act (Burr/Klobuchar) Leading the Sunshine Act fight
We need your help! 17 Our founding members have provided the necessary lift to get CME Coalition off the ground. Now, we need the participation of at least six more members to sustain our efforts and keep our Coalition going. Annual membership dues are only $15,000 per company and $2000 for non-profit associations and institutions. Please consider joining CME Coalition in 2012.