The Department of Health and Human Services Office of Inspector General issued its draft compliance program for pharmaceutical manufacturers on September 30, just three months after the Pharmaceutical Research and Manufacturers of America introduced its Code on Interactions with Health Care Professionals. While there are some similarities in intent — both documents aim to prevent pharmaceutical representatives from offering cash, gifts, or other incentives to physicians to induce them to prescribe or recommend particular drugs, or to switch patients from one medicine to another — the OIG guidance is much broader in its sweep and less specific. And while the PhRMA code recognizes the value of independent CME and dovetails with the Accreditation Council for CME and American Medical Association guidelines, the OIG guidance seems to imply that CME could fall under government scrutiny. Historically, CME has offered more of a safe harbor from government regulation.

Is CME a Target?

In Section 2, Relationships with Physicians and Other Health-care Professionals, under the subhead Other Remuneration, the draft lists arrangements that potentially implicate the federal anti-kickback statute. These include “sponsorship or other financing related to third-party educational conferences and meetings attended or taught by physicians or others in a position to generate or influence referrals; and grants for research and education.” Does this refer to accredited CME?

“Yes, that language is broad enough to cover CME and I think represents a step further than the OIG has gone in the past,” says David J. Bloch, attorney at law, Reed Smith Shaw & McClay LLP, Washington, D.C. However, Bloch, who represents pharma firms, makes the clarification that when taken in the context of OIG's past statements, the guidance is directed at sham grants and educational programs, rather than at legitimate CME.

Are CME providers and commercial supporters protected then, as long as they follow ACCME guidelines? “Certainly there's nothing in here saying that we no longer accept the ACCME guidelines,” Bloch says.

“The OIG Guidance should not present a threat to the ‘safe harbor’ status of CME when industry, providers, and third-party education companies are in compliance with PhRMA, ACCME, AMA, FDA, and related guidances,” agrees Robert F. Orsetti, assistant vice president, Center for Continuing and Out-reach Education, University of Medicine and Dentistry of New Jersey in Newark. “There is no reason for commercial supporters to reduce their commitment to CME funding. It could happen, however, that CME funding to accredited providers will increase as a further safeguard against OIG challenge.”

But the problem is that the guidance is not specific enough, Bloch says. “There is no discussion of how or why or what is an appropriate forum for sponsoring third-party education and what's an inappropriate one.” Ursula B. Bartels, senior vice president, general counsel and secretary, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., suggests CME providers seek clarification. “The OIG ought to reconfirm the importance of CME and make the point that they were not trying to say that CME is bad. That's the opposite of the message I think that they want to convey.”

Strengthen Disclosure

In the same section under the subhead Consulting and Advisory Payments, the draft says that when pharmaceutical firms engage healthcare professionals to perform consulting activities, including speaking at meetings, these arrangements pose a “substantial risk of fraud and abuse; without appropriate safeguards they can result in payment for referrals.” The guidance goes on to say that “payments should be fair market value for the services rendered, and manufacturers should take steps to ensure appropriate documentation of the fair market value determination, as well as the performance of the services.”

While the experts we spoke with agreed that the statements are aimed at speakers' relationships with pharma firms, not with CME providers, there may be implications for CME. “One interpretation might be that if consultants for a pharmaceutical company are faculty members for an educational program, they could inappropriately try to influence the audience,” says Karen M. Overstreet, EdD, executive vice president, operations, Nexus Communications Inc., North Wales, Pa.

But as long as CME providers adhere to disclosure and other guidelines “it shouldn't be an issue at all.” In addition to having presenters disclose their relationships with drug firms, Over-street says it would be a good idea for CME providers to ask the members of their education and CME committees to also disclose their relationships with pharma firms and and speakers bureaus.

And because speaker honoraria is such a gray area, Barbara Barnes, MD, associate dean, continuing education, University of Pittsburgh School of Medicine, says it behooves providers to create “a paper trail that documents due diligence,” in determining honoraria and associated reimbursements.

PhRMA Code — Floor Not Ceiling

The section goes on to say that “a good starting point for compliance purposes is the PhRMA code,” and that “the OIG recommends that pharmaceutical manufacturers at a minimum comply with the standards set by the PhRMA code. The arrangements that fail to meet the minimum standards set out in the PhRMA code are likely to receive increased scrutiny from government parties.” Bartels, who, as former chair of PhRMA's law section, spearheaded the development of the Code, was “surprised and disappointed” by the comments. “What PhRMA and its members were trying to do was set a high voluntary standard and by saying that the high standard now becomes the minimum — the ceiling becomes the floor — it's going to be a disincentive to people who are trying to do the right thing.”

The OIG has gathered comments and is expected to issue a final version in early 2003. For the full document visit: http://oig.hhs.gov/fraud/docs/compliance guidance/draftcpgpharm09272002.pdf.

For an analysis by the law firm Arnold & Porter, which represents drug firms, visit www.arnoldporter.com/pubs/files/drugpricingguide.pdf.