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27 posts from January 2010

January 28, 2010

Partners Health Care: Policy Implementation on CME

In a roll out of their conflict of interest policy, Partners Health Care (several hospitals serving Harvard University) recently announced “changes pertaining to industry support for medical education throughout the Partners organization.” They specifically noted that some of these changes became effective on January 1, and others become effective on May 1, 2010.

Part of the changes included a newly created “Education Review Board (ERB) responsible for approval and oversight of all industry gifts supporting educational programs and activities in Partners hospitals.” The board consists of members from the clinical, scientific, education, and patient advocacy communities and, to our knowledge, it is the only one of its kind in the nation. A list of the ERB members is on their website.

Regulations that became effective January 1, 2010, included a review by the ERB of “specific industry-supported proposals which until now have been carried out by a subcommittee of the Partners Education Committee (PEC).” Partners noted that the “will continue its valuable role of review and approval of Graduate Medical Education programs sponsored by Partners hospitals.”

Pat of the changes included reviewing all agreements for industry support of educational programs and activities through the Office for Interactions with Industry, rather than hospital development offices.

Regulations that become effective May 1, 2010, include using the ERB to ensure that all industry support of educational programs meets these Commission-recommended requirements:

-   funding for a specific program or activity must come from more than one company;

-   any continuing medical education program that involves conferences or lectures, or other forms of presentations, must meet Accreditation Council for Continuing Medical Education or comparable standards (as determined by the ERB), whether for CME credit or not;

-   a more rigorous process to screen potential conflicts of interest and monitor content of programs will be applied.

Partners noted that these new policies represent a “cultural change” that will take “time, thoughtfulness, and a sustained commitment from the entire Partners community.” The Partners Office for Interactions with Industry, which administers these policies, has developed FAQ's on the website.

ACCME Call for Comment: Transparency, Knowledge and Recognition

This week the ACCME issued a “Call for Comment” on three areas of CME. 

Call for Comment: Balancing Transparency

The Accreditation Council for Continuing Medical Education (ACCME) recently announced that it is seeking comment on a proposal for balancing transparency and confidentiality in the Complaints and Inquiries Process. Click here to access a webpage where you can listen to an audio explanation of this proposal, provided by Murray Kopelow, MD, ACCME Chief Executive.

Part of this process for comments is a result of ACCME being increasingly asked to investigate the issues about commercial bias and/or content validation. ACCME asks an expert in the clinical or therapeutic area to offer an opinion as it relates to content validity or commercial bias. After the Inquiry, the provider must demonstrate compliance through a Notice of Corrective Action and/or through a Monitoring Progress Report.

The ACCME announced that it received feedback from some stakeholders asking for more transparency, while others expressed concerns about providers' confidentiality. To balance transparency with confidentiality, the ACCME determined that the Complaints and Inquiries Process should follow a model similar to that of the accreditation review process. As a result, ACCME proposed that it make certain information about non-compliance, accreditation status changes, and complaints public.

ACCME asked that comments be submitted by March 8, 2010, and limits comments to 500 words.

Submit comments here.

Call for Comment: Knowledge-based CME Activities

ACCME is considering whether they should add the word knowledge into Criteria 1, 3, and 11.Click here to access a webpage where you can listen to an audio explanation of this proposal provided by Murray Kopelow, MD, ACCME Chief Executive.

Until 2006, ACCME accreditation requirements allowed an accredited provider’s CME program to focus entirely on changing learners' knowledge. The requirement then changed so that providers could design CME activities to change learners’ competence (i.e., strategies/skills), or performance or patient outcomes.

Accordingly, ACCME received feedback some providers favor knowledge-based activities because they are vital to physicians' continuing education and professional development. In response to these concerns, ACCME was concerned that activities and programs designed solely to change knowledge may not fulfill accredited CME’s responsibility to be accountable to the public and may not align with current U.S. quality and safety initiatives. As a result, ACCME is considering adding the word knowledge into the accreditation criteria stated above or allow some providers the option to present some activities to “change knowledge.”

The deadline for submitting comments is March 8, 2010, and is limited to 500 words.  

Submit comments here.

Call for Comment: ACCME's Recognition Process

ACCME is also seeking comments regarding a new and simpler procedure for receiving and analyzing information from Recognized state and territory medical societies. Click here to access a webpage where you can listen to an audio explanation of this proposal, provided by Murray Kopelow, MD, ACCME Chief Executive.

It was noted that through a traditional self-study and survey-interview process the ACCME gathers information about the accreditor that is analyzed by the ACCME’s Committee for Review and Recognition (CRR). The CRR forwards recommendations regarding Recognition to the ACCME’s Decision Committee which then go on to the Board of Directors of the ACCME for ratification. There are currently 45 ACCME Recognized Accreditors that in turn accredit 1518 institutions and organizations.

Accordingly, in July 2008, the ACCME approved a new set of Recognition requirements based on an Equivalency construct
("Markers of Equivalency”). As a result, ACCME is seeking comments about the following proposed process for verifying compliance with the Markers of Equivalency on a continuous, rather than an episodic basis, as explained below.

Proposed 2010 ACCME Recognition Process

The ongoing verification of compliance with the ACCME’s Markers of Equivalency will be done by ACCME on a continuous, rather than an episodic basis. Accreditors will continue to submit information and/or evidence from their programs of accreditation of providers; ACCME will analyze the information to ensure it verifies Equivalency; and the ACCME will determine the Recognition outcome.

Accreditor’s will then be required to submit their accreditation policies and procedures to be reviewed for consistency with national requirements and the Markers of Equivalency as specified by the ACCME. In addition, each accredited provider must provide

•A completed self study report ( or “Application” ) from the provider
•One complete CME activity file that was reviewed by the accreditor
•All completed surveyor data collection forms
•All correspondence between the accreditor and the provider
•Documentation of actions taken by the accreditation body which specify the accreditation term and accreditation status awarded
•Follow-up reports (e.g., progress reports), if required

Additional changes are listed on the comments page. The deadline for submitting comments is March 8, 2010, and is limited to 500 words.

Submit comments here.

The ACCME takes these calls for comments very seriously, and you are encouraged to submit input on these issues.


New York Governor Paterson’s Proposed Restrictions on Pharmaceutical Support of Education – The Details


Earlier this week, New York Governor David Paterson announced that his administration would propose new, tougher prohibitions on pharmaceutical, biotech and medical device companies (medical manufacturing companies), restricting them from dispensing gifts and misleading production information to doctors while promoting the use of specific drugs.


Below is a summary of the proposed changes: 


The bill attempts to “ensure that the relationship between medical manufacturing companies and health care professionals does not interfere with the independent judgment of such professionals in making prescribing decisions."


The bill would require companies to have a written contract specifying the nature of the consulting services to be provided and the basis for payment of those services. Companies and professionals would also have to demonstrate a “legitimate need” for the services.


Health care professionals would also have to maintain records about the use of consulting services. This section would also require meetings for consultants to be held in a “conducive” venue.

The New York legislation states that medical manufacturing  companies will be prohibited from providing a health care professional “any  financial  support,  including but not limited to any grant, scholarship, subsidy, support, consulting contract, speaker contract  or educational  or  practice-related  items  to reward the professional for having prescribed particular drugs, biologics or medical devices in  the past, or to induce the professional to prescribe or continue prescribing particular drugs, biologics or medical devices in the future.” This prohibition does not include compensation for bona fide consulting services or speaker services.


The bill would not prohibit medical manufacturing companies from giving health care professionals rebates or discounts. The bill would still allow “the investment of a medical manufacturing  company in a business venture in  the  medical manufacturing   or  biotechnology  field in which a health care professional is a principal, or other joint arrangement between a  medical manufacturing  company  or  health  care  professional  in  such a venture, provided that the relationship between the company and the  professional chiefly  relates  to  such  venture and is not intended to influence the professional's prescribing decisions.”


With regards to promotional materials, the bill states that “medical manufacturing companies are prohibited from providing any promotional materials to a health care professional unless such materials:


 (a) are accurate and not misleading;

 (b) make claims about a product only when properly substantiated;

 (c) accurately reflect the balance between risks and benefits;

 (d)  are consistent with all other requirements of the united states food and drug administration governing such communications; and

 (e) do not violate the provisions  of  article  twenty-two-a  of  the general business law.


Medical manufacturing companies would also be prohibited from providing meals to health care professionals and staff unless such meals:


(i)    are provided  in  connection with structured, oral informational presentations that provide scientific or educational value;


(ii)  are served only for consumption during such presentation and are not offered or served at  another  time  or  place  or outside the presence of the medical manufacturing  company;


(iii)  are,  provided only in the professional's office  or in a hospital setting; are “modest;”


(iv)  are  not offered  or provided to spouses or other guests of a health care professional;


(v)  are not part of an entertainment or recreational event; are on no more than an occasional basis; and are “conducive to informational communication.


Outside of the professional’s office or hospital settings, medical manufacturing companies can provide health care professionals meals if they are incidental; are not part of entertainment or a recreational event; are conducive to informational communication and training about medical information; are modest; and are on an occasional basis.


In addition, medical manufacturing companies cannot offer health care professionals, and no health care professional can accept any entertainment or recreational items. This section does not apply to health care professionals employed by the medical manufacturing company on a full-time, salaried basis.


Continuing Medical Education


Concerning continuing medical education (CME), the bill states that “no medical manufacturing company shall be a provider of any CME program within the state.” Moreover, the legislation states that no  medical manufacturing  company  shall be a sponsor of any continuing medical education program  within  the  state  unless  the  company  has adopted and is in compliance with policies by which the company:


(i)  has separated its continuing medical education grant-making functions from its sales and marketing departments and does not  permit  its sales  and marketing departments to have any involvement in its continuing medical education grant-making activities;


(ii) has developed and utilizes objective criteria for making continuing medical education grant decisions to ensure that the program  funded by the company is a bona fide educational program and that the financial support  is  not  an  inducement  to prescribe or recommend a particular medicine or course of treatment; and


(iii) agrees to respect the independent  judgment  of  the  continuing medical  education  provider  and  to  follow  standards  for commercial support established by the accreditation council for continuing  medical education.


Medical manufacturing companies are also prohibited from:


-   Providing any advice or guidance to the CME provider, regarding the content or faculty for a particular CME program funded by the company; and


-    Providing any verbal  or  written  information  to  a  health  care professional  who is expected to serve as a presenter at such CME program regarding any drug, biologic or  device  manufactured,  distributed or marketed by or on behalf of the company.


-   Providing any financial support in connection with the professional's attendance or presentation at a CME program, including time spent attending or presenting at the CME program or to reimburse the professional for the costs of travel, lodging, or other personal expenses incurred for attendance or presentation at the continuing medical education program.


-   A full-time salaried employee of a medical manufacturing company, or who is engaged by the  company  as a speaker or consultant for a CME program can receive financial support for time and travel expenses.


This is already the case for CME programs under the ACCME accreditation system and similar systems.


Especially cumbersome is the proposed rule that no health care professional practicing in the state shall attend or present at any continuing medical education program sponsored by any pharmaceutical  company unless advised by the program provider that such medical manufacturer has provided assurance that it  has  adopted the policies stated above.  This will require some type of certifications for every company that exhibits at your meeting regardless of the size of the exhibit or amount of contribution.



The bill states however, that a CME provider can use its own discretion to apply financial support received from a medical manufacturing company to reduce the overall CME registration fee for all attendees. Medical manufacturing companies however cannot provide meals directly at CME programs, except that a CME provider at its own discretion may apply the financial support provided by a company for a CME program to provide modest meals for all participants. 


Health care professionals who present at CME programs:


-    May not represent that he or she authored any materials discussed, distributed or otherwise presented during his or her presentation at such unless he or she made “substantial contributions” to the intellectual content of such materials.


-   Presenters must also disclose during their presentation the existence and nature of any financial support he  or  she  has  received  from  or expects  to  receive from a sponsor of such continuing medical education program or from a medical manufacturing  company that medical manufacturing , distributes or markets any drug, biologic or medical device discussed in such  presentation  or  commonly  prescribed  for  a  disease, injury or condition discussed in such presentation.


FDA Regulated Education


FDA regulated conference or meetings also have similar restrictions as CME programs regarding medical manufacturing company financial support.


Medical manufacturing companies who retain a health care professional as a speaker:


-  Are required to place caps on the total amount of annual compensation it will pay to an individual health care professional in connection with all speaking arrangements at a reasonable amount.


-    Have to provide periodic monitoring of speaker programs for compliance FDA requirements for communications on behalf of the company about its medicines.


-    Companies must also have each speaker clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.


Speakers or consultants who are a member of a committee that sets formularies or develops clinical guidelines are prohibited from speaking or consulting unless the company requires that the professional disclose to such committee the existence and nature of his or her relationship with the company, for as long as such relationship lasts and for at least two years after such relationship is terminated.


Medical manufacturing  companies are also prohibited from providing financial assistance  for  scholarships  or  other  educational  funds to permit medical students, residents, fellows, and other  health  care  professionals  in training to attend educational conferences unless: (a) such conferences are sponsored by the major educational, scientific,  or  policy-making  meetings  of  national,  regional,  or specialty medical associations; and (b) the selection of individuals who will receive  the  assistance  is made by the academic or training institution.


With regards to gifts, medical manufacturing  companies cannot provide to health care professionals or members of their staff floral arrangements, artwork, compact discs or tickets to a sporting event, pens, note pads, or mugs, except for educational items.   


In relation to health care professionals items designed primarily for the education of patients or health care professionals, medical manufacturing companies are allowed to provide such items as long as they are not of substantial value, and are not offered on more than an occasional basis.


Penalties for a medical manufacturing company for breaking any section in the proposed bill are a minimum of $15,000 and a maximum of $250,000 per violation. Individual health care professionals who violate any section of the proposed legislation are penalized not less than $5,000 and not more than $20,000 per violation.


Many of the rulings are already in place under the PhRMA Code.  This would however add new restrictions on freedom of assembly (attendance at meetings..).  The proposal calls for an end of outside funding for fellows programs (which is a valuable service that companies provide to Universities).


Overall this is one of the most restrictive proposals for physician education.  By adding additional restrictions to education it will limit information sources of physicians and in the end hurt patients.    With Paterson’s popularity at an all time low it is likely this proposal is dead on arrival.  But it does give us insight as to the next generation of restrictive measures proposed in states.


Physicians and organizations who collaborate with medical manufacturing companies in New York should express outrage at such proposals.



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