The Council of Medical Specialty Societies (“CMSS”) recently issued a voluntary Code for Interactions with Companies (the “CMSS Code”) that sets forth guidelines for interactions of medical societies and key leaders of those societies with pharmaceutical and medical device companies.1 The release of the CMSS Code follows on the heels of significant developments in federal law that require industry disclosure of financial relationships with physicians and other entities. In light of this latest development, pharmaceutical and medical device manufacturers may wish to review their current policies and procedures to ensure that their interactions with medical societies are consistent with current best practices. We would be pleased to provide assistance in this process.
By its terms, the CMSS Code applies to CMSS member societies that agree to adopt the Code. The CMSS Code does not apply directly to individual society members, except for member societies’ key society leaders (e.g., presidents, chief executive officers, and editors-in-chief of society journals). In addition, although the CMSS Code is not directly applicable to pharmaceutical and medical device manufacturers, it should nonetheless be of particular importance to such organizations because it represents a potentially relevant source of guidance for organizations of medical professionals. Moreover, the CMSS Code in some respects sets more stringent standards than the Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America (the “PhRMA Code”), the Code of Ethics on Interactions with Health Care Professionals developed by the Advanced Medical Technology Association (the “AdvaMed Code”), and the Accreditation Council for Continuing Medical Education Standards for Commercial Support (the “ACCME Standards”).
At least fourteen medical societies have formally adopted the CMSS Code, including the American Society of Clinical Oncology, the American College of Cardiology, and the American Academy of Family Physicians. CMSS expects that additional member and non-member societies will adopt the CMSS Code in the near future.
A. Overview of the CMSS Code
The stated purpose of the CMSS Code is to ensure independence, transparency, and the advancement of medical care for the benefit of patients and population groups. The CMSS Code sets forth ten key principles for member societies’ interactions with industry and “annotations” that explain CMSS’ current interpretation of certain key principles. The CMSS Code’s guidelines focus on the following three general concepts:
- Minimizing actual and perceived conflicts of interest with for-profit pharmaceutical and medical device companies;
- Increasing the transparency of industry support, including public disclosure of support, financial relationships, and donations received from for-profit pharmaceutical and medical device companies; and
- Ensuring the independence of member society activities, including continuing medical education (“CME”) programs, educational programs, member society meetings, research grants, and the development of clinical practice guidelines, from industry supporters.
B. Key Provisions in the CMSS Code
The CMSS Code sets forth specific guidelines for industry support of society-sponsored CME programs, educational programs, and society meetings. While the subject matter covered by the CMSS Code generally overlaps with that addressed in the PhRMA Code, AdvaMed Code, and ACCME Standards, the CMSS Code is more stringent than its predecessors in several respects. For example, the CMSS Code requires member societies to disclose to its members and the public the names of any companies providing support for CME, corporate sponsorships, charitable contributions, and research grants. The CMSS Code also requires member societies to make reasonable efforts to seek multiple industry sponsors for society-sponsored events or programs and to place exhibit booths sponsored by industry out of attendees’ “obligate path” to society CME sessions. In addition, the CMSS Code requires satellite CME symposia (i.e., industry-supported CME programs held as an adjunct to a society meeting where CME credit for the symposium is provided by a third-party CME provider and for which a member society receives a fee) to undergo an application and selection process and requires such programs to use appropriate disclaimers to distinguish such symposia from society CME programs in advertising and program materials.
In addition, the CMSS Code also includes specific guidelines applicable to the development of medical society-sponsored clinical practice guidelines. Like the PhRMA Code, the CMSS Code requires individual members serving on a committee or panel responsible for developing a clinical practice guideline to disclose all relevant relationships with industry and to update such disclosures throughout the development process. Although the CMSS Code requires that at least one panel chair and a majority of individual members developing clinical practice guidelines be free from conflicts of interest relevant to the subject matter of the guideline, significantly, it does not prohibit all members or their institutions from holding any potentially relevant relationship with industry. Additionally, CMSS member societies adopting the CMSS Code are prohibited from accepting direct industry support for the development of clinical practice guidelines or guideline updates, including the initial printing, publication, and distribution of such guidelines. Member societies are permitted, however, to accept industry support for the society’s further distribution of the guideline, translation, or repurposing of the clinical practice guideline content.
Importantly, the CMSS Code also places restrictions on certain individual society members. For example, the CMSS Code prohibits key society leaders from having any “direct financial relationship” with for-profit pharmaceutical and medical device companies during his or her term of service. A “direct financial relationship” is defined under the CMSS Code as any “compensated relationship held by an individual that should generate an IRS Form W-2, 1099 or equivalent income report.” However, key society leaders are permitted to provide uncompensated services to pharmaceutical and medical device companies and to accept reasonable travel and reimbursement in connection with those services. In addition to prohibiting direct financial relationships, member societies are also required to disclose to individual members and the public all financial and uncompensated relationships that key society leaders and members of the society’s board of directors have with pharmaceutical and medical device companies. The CMSS Code explains that such disclosure should include employment, consulting, or advisory arrangements, stock ownership, honoraria, researching funding paid to an individual’s institution or practice, expert testimony, and any gifts.
The issuance of the CMSS Code represents only the latest effort to bring additional clarity to the subject of interactions with industry and health care professionals.