CME Under FireCME Under Fire

THOMAS SULLIVANTHOMAS SULLIVANPresidentPresident

Rockpointe CorporationRockpointe CorporationMarch 6, 2009March 6, 2009

DisclosureDisclosure• Rockpointe is a Science based Medical education company of

25 full time employees based in Columbia Maryland • The Potomac Center for Medical Education is an ACCME

accredited provider and receives financial grants from pharmaceutical and device manufactures

• I am committed to the free flow of ideas in CME and support the current ACCME Standards for Commercial Support™

• Author of the website policy and medicine www.policymed.com

What is CMEWhat is CME

• Continuing medical education is important for: – Everyone in the field of medicine– Maintenance of competency/ licensure/board

certification and hospital privileges – Uptake and the free flow of new information and

practices– Translation of 150,000 journal articles published

each month

Certified CMECertified CME::• Education produced by an accredited CME provider

(not easy process)• Complies with ACCME and other accrediting bodies

standards• Complies with federal compliance FDA/OIG guidance• Content and delivery are independent of supporter

(commercial) influence• Complies with the AMA definition of CME• Does not pay for participation, expenses, travel

Promotional Programs – Non CME Promotional Programs – Non CME Events/CoursesEvents/Courses

• Promotional Education– Pharma or Device company directed– Must stay on FDA Label– Reviewed by FDA and HHS IG’s office– Can not be altered by speakers– Designed to familiarize HCP’s with approved Drugs/

Devices and approved indications

Financial Support for CMEFinancial Support for CME

• 50% from private and public sources (subscriptions and attendee fees)

• 50% from grants including industry support• Grants Represent $1.2 Billion of support

(2007)• Little support from public health, insurance

companies, hospitals/health systems, universities

Regulatory Stakeholders in CMERegulatory Stakeholders in CME

• FDA • HHS IG• Congress• States Attorney Generals• State Legislatures• Corporate Integrity Agreement s• PhRMA -- AdvaMed• CMS• ACCME • AMA , AAFP, ACPE, ANCC, State medical boards

How is CME regulatedHow is CME regulated

• Federal and ACCME rules require that accredited providers:– Ensure that content is evidence based– Conflicts of Interest Disclosed and Resolved

• Speakers, staff, writers….– Independence of Provider– On-Site Audits– Public Disclosure of Accreditation Status

Physicians ChoicePhysicians Choice

• CME agenda is controlled by medicine• Physicians are not paid to attend CME • Participation is voluntary• Physicians evaluate for Bias• Varied CME opportunities: associations, journals,

internet, meetings• Quality wins out

Points to Consider with CMEPoints to Consider with CME

• Commercial and Public Interest are not incompatible

• No evidence that commercial bias is harmful or wide spread

• Changes accelerated over last four years• No viable alternative to funding• Changes in regulations can have profound effect on

patient care especially in rural and inner-city areas.

Revised PPSA 2009 and CMERevised PPSA 2009 and CME• Reporting Payments over a cumulative value of

$100 dollars.• Requires Reporting of:

– Honoraria, Food, Travel, Education

– Compensation for serving as a faculty member or as a speaker for a continuing medical education program

– Grant

– Any other nature of payment or other transfer of value as defined by the secretary

• Collection of Medicare Billing Number

PPSA 2009 Language (Direct Payments)PPSA 2009 Language (Direct Payments)

• Provides a payment or other transfer of value to covered recipient (or to an entity or individual at the request of or designated on behalf of a covered recipient)

• Question – Does this exempt reporting information on CME participants and faculty and if so how?

PPSA 2009PPSA 2009Compensation as a CME Faculty or SpeakerCompensation as a CME Faculty or Speaker

• Local CME Providers– Must provide “timely” information to supporter on

speaker compensation, travel and incidental expenses– Manufacturers will be hesitant to give small grants

• Multi Supported Programs– Would you apply the full payment to the physician to

each supporter.• Drive away non-conflicted faculty

PPSA 2009PPSA 2009Collection of Medicare Billing NumberCollection of Medicare Billing Number

• For CME events and activities this could be considered a problem due to identity theft

• Physicians don’t know this number or readily give this out

PPSA 2009 Payment ApplicationPPSA 2009 Payment Application

• If the payment or other transfer of value is related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, the name of that covered drug, device, biological, or medical supply.

• Question: CME is not brand or device specific, and the language directly references education what is this meant to capture?

PPSA 2009 Effect on Exhibits at National PPSA 2009 Effect on Exhibits at National MeetingsMeetings

• Reporting cumulative payments of $100– Negative effect on convention business– Exhibits would have to keep track of

• Educational Items Distributed and Value• Coffee/Tea stations at exhibits (would have to swipe

your card for coffee)• Will reduce overall traffic to exhibit (physicians

hesitant from giving their information just because they visited an exhibit hall)

Changes to ReportChanges to Report

• Physicians but not Manufactures can change report• No resolution for physicians to change prior to the

publishing of the report.

Pre-EmptionPre-Emption

• No Pre-emption of additional requirements• Without some type of true pre-emption, states will

be able to pass additional restrictions (this could become a never ending process)

American Academy of Family Physicians American Academy of Family Physicians GoalsGoals

• Minimizes the administrative burden that reporting requirements would place on physicians;

• Enables the physician to correct incorrect reporting data before the companies releases it for publication; and

• Ensures the reporting requirements do not have a chilling effect on efforts to educate physicians about research and new developments in diagnosis and treatment.

For More InformationFor More Information

• Thomas Sullivan, Rockpointetsullivan@rockpointe.comwww.policymed.com and www.rockpointe.com

• John Kamp, Coalition for Healthcare Communication www.cohealthcom.org

jkamp@cohealthcom.org