1. 1
CME COALITION:
A CALL TO ACTION
RESPONSE TO THE PROPOSED
RULE ON THE SUNSHINE ACT

2. 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.

3. The Proposed Rule
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 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.

4. What is at Stake?
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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.

5. Proposed Rule and Third Parties
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 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…)

6. Proposed Rule and Third Parties
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 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)

7. Certified CME Is Different
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 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

8. Impact on CME Providers
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 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

9. Impact on CME Supporters
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 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

10. CME Scenarios
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 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)

11. Key Questions
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 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?

12. Public Reaction
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 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

13. Next Steps
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 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)

14. Call to Action
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 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!

15. Why Join the CME Coalition?
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 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.

16. CME Coalition Highlights -
The First 6 Months
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 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

17. We need your help!
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 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.

18. CME Coalition - Membership
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19. Thank you
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Chris Lamond, Executive Director
clamond@thornrun.com
(202) 688-0222
Andrew Rosenberg, Senior Strategist
(202) 247-6301
arosenberg@thornrun.com
CME Coalition
www.cmecoalition.org