As most of you probably know, biotechnology company Serono, based in Geneva, Switzerland, agreed in October to pay $704 million to the United States federal government to settle charges that it illegally marketed its AIDS drug Serostim. According to newspaper reports, the settlement was the third-largest ever recovered by the government in a healthcare fraud case.
As part of the settlement, Serono Holding Co. entered into what is called a corporate integrity agreement with the Office of Inspector General (OIG). While the corporate integrity agreement has clear ramifications for drug companies' marketing efforts, it also will likely have an effect on relationships between CME providers and commercial supporters, as it requires Serono to develop thorough policies and procedures for commercial support of CME.
Under the agreement (available online at http://oig.hhs.gov/fraud/cia), Serono must spell out key processes for the awarding of grants. Detailed records need to include disclosure of the financial support and any financial relationships Serono has with the faculty, speakers, or organizers of the activity. The activity Serono finances must be nonpromotional, educational in focus, and independent of any input from the supporter (unless specifically requested in writing by the CME provider.). While the Accreditation Council for CME-suggested letter of agreement does cover the above points, you can expect that the letters of agreement used by Serono and other supporters will become more thorough in these areas. Here are the key points relevant to CME.
Letters of agreement for CME grants must be signed by all relevant parties, including a joint sponsor. (This is also an ACCME requirement). The agreements must include clauses stipulating that applicable contractors and subcontractors comply with Serono's compliance program (Serono will attach a copy of its Code of Ethics and other applicable policies and procedures) and that all parties agree not to violate the federal anti-kickback statute or relevant FDA requirements. Providers must state that they will maintain records relating to the activity and that they are subject to an audit by the supporter or its agent.
The lesson: Be sure to determine how long those files are to be kept, as rules may conflict with ACCME guidelines. The ACCME requires files to be kept until the completion of the next self-study review. Assume that everything you put in a file is “discoverable,” and train yourself to be appropriate in your written communications. Document what is required and eliminate extraneous materials not germane to the educational or commercial support process.
The corporate integrity agreement states that only the CME provider may have control over an educational activity receiving support. It specifically prohibits Serono from directing the content, influencing the CME sponsor regarding content, and scripting or emphasizing certain content. The agreement also says that only the CME provider may have control over faculty selection. The supporter is forbidden from making speaker suggestions unless the request is initiated by the CME provider, and when responding, Serono must suggest more than one name, provide speaker qualifications, disclose financial and other relationships between the supporter and suggested faculty, and provide this information in writing.
The lesson: Do not endear yourself to supporters by quietly collaborating with them on content development. Maintain a defensible planning process that is controlled by your staff and faculty experts. Clearly document this process. Assume that any form of communication with the supporter may be audited at a later date. A compliant supporter will want to keep their distance from involvement in content, and your standards in that regard should be above reproach.
The funding process should include legal review of all policies and procedures relating to compliance with anti-kickback statutes and FDA requirements. Such reviews are required for any grant in excess of $5,000 or where the aggregate amount of grants to a single CME provider exceeds $10,000 in the reporting period (typically one year). The company's compliance officer shall conduct reviews of records for grants twice each year.
The lesson: Compliance officers, when concerns arise, may opt to audit the records of the CME provider. Such audit requirements will start to appear in letters of agreement. If CME providers are maintaining their files in accordance with ACCME requirements, then there should be no concern. CME providers should consider a fee for responding to audit requests that is reasonable and consistent with staff time needed to prepare and ship materials, or to compensate for staff time for an on-site audit.
To summarize, we advise all CME providers to take the following steps:
Only plan CME activities that are truly based on need, that are important for the profession and the quality of patient care, and that are cost-effective. If this is done, then the grant request is pure and defensible. Don't forget that the anti-kickback statutes refer to the advocacy or promotion of processes that unnecessarily increase the cost of medical care for federal programs (Medicare and Medicaid are universal and therefore can be connected to all education). This doesn't mean that you shouldn't provide education for something that is truly important to quality AND also may increase cost. The key is “quality.” You should be able to state (and do so in your grant application) why the grant is important to the public interest.
Validate the content of all CME activities. This should be done by an independent reviewer. It is important to be able to document both for the supporter and the public interest that funds have been wisely spent, that the content of the activity was not commercially biased, that patient care recommendations were appropriate, and that studies used were scientifically rigorous. Written content review must be maintained in files.
Do outcomes studies on all CME activities. At a minimum, document that physicians actually implemented practices that were highlighted in your learning objectives or that desired patient care results were achieved. Many grantors today are recognizing the value in outcomes measures and are insisting on such measures in grant applications. Indeed, such emphasis on realistic outcomes measures that are tied to needs and objectives are increasingly the mark of a well-qualified CME provider.
Implement an aggressive conflict-of-interest management and resolution process. By spelling out your process in your grant application, you will provide assurance to the supporter that your CME program is functioning appropriately and is defensible should there be an inquiry. In case of an audit, your files should have detailed information on conflicts of interest and how they were resolved.
Implement a rigorous quarterly in-service training program to assure that your staff understand the full set of regulations governing the CME enterprise — from those promulgated by the ACCME and the American Medical Association to the Office of Inspector General and FDA guidelines.
Steve Passin is president of Steve Passin & Associates, LLC, a CME and pharmaceutical consulting firm based in Newtown Square, Pa. Reach him at passin@passinassociates.com. Susan O'Brien, senior associate, SP&A, contributed to this article.