The proposed HHS rule on the Physician Payment Sunshine Act would require CME providers and supporters to report all payments and transfers of value to physicians, including indirect payments. This would create a significant new reporting burden on CME organizations that is inconsistent with the intent of the Act. The CME Coalition is launching efforts to provide comments opposing this overreach in the rule and engage Congress to address concerns over its impact on accredited CME. It calls on the CME community to submit comments, contact congressional representatives, and join the Coalition in its advocacy.

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

2. 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.

3. 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.

4. Proposed Rule and Third Parties
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 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…)

5. Proposed Rule and Third Parties
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 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)

6. Certified CME Is Different
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 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

7. Impact on CME Providers
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 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

8. Impact on CME Supporters
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 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

9. CME Scenarios
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 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)

10. 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?

11. 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

12. 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.
 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)

13. 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!

14. 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.

15. 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