Author + information
- W. Douglas Weaver, MD, FACC, ACC President⁎
- ↵⁎Address correspondence to:
W. Douglas Weaver, MD, FACC, American College of Cardiology, 2400 N Street NW, Washington, DC 20037
The American College of Cardiology (ACC) leaders recently initiated a meeting with representatives from the U.S. Office of the Inspector General (OIG) and the U.S. Department of Justice (DOJ) to discuss how we address conflicts of interest and relationships with industry and funding for the College's educational meetings and other activities. Many of you are probably aware that industry supports a broad array of College activities including professional education, quality programs, the Annual Scientific Session Expo, and digital products through educational and other types of grants. This support, which constitutes about 38% of the College's revenues, enables the College to provide programs that we would otherwise not be able to offer. In addition, without this support, the registration fees for the Annual Scientific Session and i2 Summit would have to be more than double their present amount, and member dues would have to increase significantly.
We discussed with the OIG and DOJ representatives that the College's science and education has been and will remain objective, independent, and evidence-based despite industry support because of the College's long-established and solid “firewalls” between content development and such external support. With all such activities, the College adheres to our own strict internal policies and procedures to manage conflicts of interest and relationships with industry, as well as follows guidelines established by the American Council for Graduate Medical Education (ACGME).
These unrestricted educational grants from industry to support medical education and parts of our quality initiatives are important to the College. Without them, our ability to improve the quality of medical care would be curtailed considerably, and, unfortunately, I do not see state and federal governments or insurance companies stepping up to be likely sources for this funding. As it is, the ACC estimates that our members actually pay 80% to 90% of their continuing medical education costs out of pocket.
Whether it is due to pressure from external or internal forces, we are seeing changes in the relationships between industry and medical providers. Pfizer has decided that it will no longer offer educational grants to for-profit meeting organizers, for example, commercial medical education companies. Other pharmaceutical companies will most likely follow. The Association of American Medical Colleges (AAMC) has suggested to medical schools that pharma-sponsored gifts, lunches, and educational sessions should also cease. The American Medical Association announced several months ago that anyone who had received $10,000 or more from industry in his or her lifetime could no longer be a representative on the Relative Value Scale Update Committee.
In recent months, I have met with several congressional members to impress upon them the value of using our guidelines, performance measures, and appropriate use criteria to improve the value of care provided to patients. Some members commented that the documents “are written by persons with industry conflicts, so we need a less conflicted body to produce such documents.” Massachusetts has enacted legislation requiring public disclosure of gifts from a pharmaceutical or medical device manufacturing company valued at $50 or more. The federally-proposed Sunshine Act for public disclosure has been endorsed by the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association, as well as the ACC.
Clearly, the topic of industry relationships has been front and center, and the momentum is in the direction of tighter restrictions. Where all of this will end—and even more important, what the alternative business model for funding professional education will be—is not clear.
Advice for Avoiding Pitfalls
What do you need to be cautious about in your relationship with industry or other possible conflicts? Since the meeting, I have tried to educate myself more about what is on the radar screen of these governmental oversight bodies, how a person could get into trouble, and which relationships may be problematic.
All of you are likely aware of the Federal Anti-Kickback Statute that prohibits offering, paying, soliciting, or receiving anything of value to induce or reward referrals of federal health care program business. Obvious examples might be a kickback to members of a formulary committee or a reward to induce referrals. Some of the questions investigators ask include:
• Does the arrangement have the potential to affect clinical decision-making?
• Does the arrangement have the potential for overuse or misuse?
• Are the consequences of an arrangement likely to lead to increased costs for federally funded programs?
The investigators are trying to determine if anything of value is being exchanged between the parties or if someone is paying for the referrals.
Grants for education and research are legitimate as long as there is no control over the content or the speaker. Physicians may be paid for consulting; however, if their fee exceeds fair market value or the consultants are merely passive listeners while “consulting,” the relationship comes under suspicion. Compensation for “research” provided by sales and marketing divisions of a company and set up to market a product is a no-no. A fellowship stipend in return for market share of a product would also not pass muster.
Joint ventures, such as those with a hospital, ambulatory care center, or imaging center, can also be an unsuspecting trap for physicians. Are the physicians selected and retained in a manner that takes into account the value or volume of referrals? Other arrangements that raise a red flag include those in which:
• Participants are expected to make a large number of referrals to the venture and are offered a greater or more favorable business or investment opportunity for doing so.
• Participants are encouraged to make referrals or the venture tracks its sources of referrals and distributes this information to participants.
• Participants are permitted to borrow their capital investment from the venture or from another participant and pay back the loan from profit distributions.
All are red flags that the venture is a vehicle to disguise referrals, and the OIG is aware of a proliferation of joint venture arrangements. Other examples might include diagnostic laboratory services, durable medical equipment providers, or an arrangement in which you receive something for free or far below the purchase value, such as office space, accounting services, and clerical support. These ventures are set up not to merely raise capital but instead to lock up a stream of referrals and to compensate participants indirectly by sharing in profits of the venture.
Why do hospitals and others provide economic incentives to physicians? Many of these ventures are in competitive markets, and they are attempting to recruit physicians and increase patient referrals. Some physicians even solicit these incentives. In exchange, the physician is expected to bring the majority of his or her patients to the venture.
Enforcers and oversight bodies also look for recruitment arrangements promising income guarantees, interest-free loans, or turnkey setups—just bring your patients. Other suspicious activities might include payment for services that require few substantive duties, payment that far exceeds fair market value for the service, or investment opportunities that guarantee returns. If you wonder “why have they come to me” or it seems too good to be true, it probably is. Any of these things should cause you to stop and get professional advice before signing.
Drug prescriptions can also be a problem if the program is aimed at switching drugs within a class in return for either direct or indirect compensation, such as frequent flyer miles or a “research grant” in which physicians are paid for providing minimal record-keeping tasks related to a patient's condition or possible need for treatment, or for inappropriate recommendations for off-label use. All of these practices have resulted in criminal fraud and abuse convictions.
With all of this detail, it is important to note that there are “safe harbors” that can be constructed around some mutual arrangements. If you find this information of interest, let me know, and we can delve into the topic further. That said, the ACC has clearly distinguished itself by being proactive and transparent on this important topic. The information posted on www.acc.org about support from external sources demonstrates the seriousness of our commitment to transparency. Our firewalls, strict insistence and scrutiny of disclosures, and our commitment to patient-centered and scientific evidence-based medicine are the College's tradition and its future.
- American College of Cardiology Foundation