Restrictions: The Regulation of Education

In June of 2005, the Senate Finance Committee, led by chairman Senator Max Baucus and ranking member Senator Charles Grassley, wrote to 23 of the largest pharmaceutical companies to inquire about the use of educational grants. Pharma referred them to the ACCME, and the Committee sent questions to them as well. The Committee also reviewed medical literature and information in the public press.

Why did the Committee review the use of educational grants? There are several possible reasons:

• The US Committee on Finance has exclusive jurisdition over Medicare and Medicaid with 80 million Americans and a 2006 expenditure of over $700 billion, and the Committee is responsible to ensure program funds are spent properly (including prescription drug benefits).
• Drug marketing and utilization became a concern to the Committee.
• The Committee became aware that Pharma funds education programs to “help build market share.”

Their findings, released in 2007, concluded that “Pharma uses education to increase the market for their products” and highlighted concerns that the encouragement of off-label uses was resulting in increased expenditures for Medicare and Medicaid programs. While they noted that companies have taken steps to separate independent grant process funding from marketing and that independent groups have guidelines to reduce the potential for influence of content, Baucus and Grassley noted that these guidelines (ACCME) reveal inadequacies in monitoring and enforcing independence from commercial influence and are therefore open to fraud and abuse.

There are clearly some important steps that can be taken by companies involved in medical education — both client and service providers — to mitigate risk while still ensuring the delivery of quality, independent education programs:

1. Separate the education functions from marketing and especially sales. This was initially stated by the OIG in 2003.

2. Develop an objective grant approval process. Many BioPharma companies have moved to online grant submission systems with blind reviews by committees independent of the sales and marketing organizations.

There is a strong belief that the government will continue to scrutinize these processes based on two 

theories:

a. False and misleading position regarding control and/or falsity of content.

b. Payment of grants perceived as kickbacks or inducement to prescribe a company’s product

3. Maintain a “hands-off” approach with CME

4. Move funds formerly dedicated to CME to activities perceived as “safer”

5. Create internal compliance programs

Compliance departments with resulting programs and policies are becoming core functions within the BioPharma industry. Elements for an effective compliance program include: designating a separate compliance office and committee/department; implementing written policies and procedures; conducting education and training; developing effective lines of communication; performing internal monitoring and audits; enforcing policies through well-published disciplinary guidelines; and responding promptly to identified problems and undertaking corrective action.

The ACCME identifies, develops and promotes standards for physician education and accredits for-profit and not-for-profit institutions and organizations that offer continuing medical education. The Standards for Commercial Support are written for CME providers to ensure the independence of CME activities. They had previously been updated in 2004 and 2006. 

Following the Senate Finance Committee report, the ACCME issued another revision of The Standards for Commercial Support in August of 2007. Major areas of concern to grantors as well as providers include:

1. A commercial supporter cannot specify the manner in which a program will be developed. Example, a commercial supporter cannot recommend speakers or review content. Review of content is a concern to the BioPharma industry, specifically as it relates to product data and the accuracy of reporting such data. While grantors have understood that they cannot control content of a certified CME activity, in the past they have been able to review content for accuracy if requested by the provider. Again, this change becomes especially critical when there is new product data being presented and the grantor/BioPharma company may have the best resources for scientific review.

2. Definition of commercial interest:  “A ‘commercial interest’ is any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients.” No entity owned or controlled by a ‘commercial interest’ can be accredited by the ACCME system, and there are no structural or organizational “firewalls” that could be put in place for a company that is owned or controlled by a ‘commercial interest’ to suffice for accreditation. The major change in the definition is the addition of the word “marketing,” implying the restructuring of medical education companies to ensure separation from parent companies such as advertising agencies. This means, for example, that accredited medical education companies cannot remain as wholly owned subsidiaries of an advertising firm. The change reflects the overwhelming concern of the ACCME to ensure independence of certified CME. However, while attempting to exclude medical education and communication companies, the ACCME continues to exempt other types of commercial supporters such as for- and not-for-profit hospitals, health insurance providers and others from the commercial supporter definition, in effect, promoting a two-tiered system. 

3. Conflict of interest continues to remain a hot-button for CME providers. Anyone who is in a position to control content must disclose their “relevant” financial relationships within the past 12 months that could create a conflict of interest. From the speaker perspective, this includes relationships with BioPharma including participation in clinical trials, or serving in an advisory capacity, as a spokesperson, author, stockholder, etc. ACCME considers financial relationships to create a conflict of interest which could result in content bias. It is the provider’s responsibility to resolve conflict of interest with speakers.

How will the industry respond to these changes in certified CME? BioPharma must not exert any influence over the grant-making process and provision of certified CME. This has become very clear. Internal decisions regarding a company’s involvement in education will evolve over time, with considerations including the cost-benefit of funding certified CME. 

Some companies are already allocating their funds to other forms of education, including on-label, promotional programs. Other companies are directing their education funds to professional organizations, schools of medicine, and education foundations. And some companies are choosing not to fund certified CME. 

Regardless, the message is clear that certified education must remain independent of commercial influence. Ongoing dialogue with all stakeholders is critical to ensure the independence, accuracy, and value of CME for physicians and the patients they treat.