“THERE'S NO TURNING BACK NOW. It's another world,” says Steve Passin, president, Steve Passin & Associates, LLC, a CME consulting firm in Newtown Square, Pa. He's talking about the effects of recent regulatory changes — the Pharmaceutical Research and Manufacturers of America's Code on Interactions with Healthcare Professionals, the Accreditation Council for CME's proposed new Standards for Commercial Support, and the Office of Inspector General's pharma compliance guidance. “The confluence of all three regulatory documents this year have made a marked change in the way people are behaving in CME,” he says.

The most recent of these regulations, the OIG's Final Compliance Program Guidance for Pharmaceutical Manufacturers, has the most teeth. Violate its precepts and CME providers and commercial supporters could wind up the target of a government investigation. The guidance, released in April, is designed to help drug and device firms comply with federal anti-kickback laws, which prohibit them from offering incentives to induce healthcare professionals to prescribe, recommend, or purchase particular drugs or devices. One of the areas covered is education grants, so there are major implications for CME.

Safe Harbor for CME

First, the good news: Unlike the draft guidance, which made no distinction between promotional and educational activities, the final guidance reinforces the value of CME. After meeting with several groups of stakeholders, including the CME community, to gather feedback about the draft, “We realized that some of [the manufacturers'] conduct may have certain benefits, such as providing medically useful education about their products,” said Mary Riordan, senior counsel, OIG, U.S. Department of Health and Human Services, Washington, D.C. Riordan made her comments during a May 21 audioconference sponsored by the Pharmaceutical Compliance Forum. “The final guidance explicitly recognizes that pharmaceutical manufacturers often fund continuing medical education programs.”

Affording CME something of a safe harbor status, the guidance says: “Absent unusual circumstances, grants or support for educational activities sponsored and organized by medical professional organizations raise little risk of fraud or abuse, provided that the grant or support is not restricted or conditioned with respect to content or faculty.”

The final guidance also recognizes the value of existing guidelines regulating CME, stating that “manufacturers and sponsors of educational programs should be mindful of the relevant rules and regulations of the Food and Drug Administration. Codes of conduct promulgated by the CME industry may provide a useful starting point for manufacturers when reviewing their CME arrangements.”

CME Under Scrutiny

Here's the potentially not so good news: CME can be a high-risk area. “The OIG's main concern about such funding is that it not be used as a disguise to channel improper remunerations to physicians or others who may be in a position to generate business,” said Riordan.

While the FDA and ACCME rules allow funders to recommend speakers and content, as long as the CME provider retains control and makes the final decision, the guidance says that “to the extent the manufacturer has any influence over the substance of an educational program or the presenter, there is a risk that the educational program may be used for inappropriate marketing purposes.”

“That is stated in little bit broader language than has been used in the past,” says David J. Bloch, partner with Reed Smith LLP, a Washington, D.C.-based firm that represents pharma clients. “Elsewhere in the document they talk about control rather than influence. There's probably a big difference between those two words in this context. I don't know if that's really an intent by the OIG to start scrutinizing more carefully the extent to which pharmaceutical manufacturers influence CME presenters and content or not. It may just be an unintentional choice of words. But there can always be suspicion or skepticism that there's somehow undue influence when the funder of the program recommends a topic or speaker. It's not clear that the OIG was trying to change the standard for support.”

Sales Versus Education

To reduce the risk of inappropriate grant programs, the guidance advises manufacturers “to separate their grant-making functions from their sales and marketing functions.” This represents a dramatic change, say experts.

Many companies still have the majority of CME funding driven by brand teams. But now, “under no circumstances should a company have brand teams making educational funding decisions” on their own, says Michael Saxton, an independent CME consultant based in Glen Gardner, N.J. Instead, he says, educational units should be involved in the process,

In fact, a number of companies have already moved in that direction, making the grant application process more stringent, and funneling requests for CME funds through a medical education or medical affairs unit. Passin adds that drug firms are developing more sophisticated standards for choosing CME providers, and are looking for providers who, for example, do thorough needs assessments.

“We're seeing companies develop specific criteria for the acceptable forms of educational programs, whether CME, nonaccredited CME, patient/provider education, fellowship arrangements, or any other program,” said Anthony Farino, CPA, Assurance and Business Advisory Services Partner, PricewaterhouseCoopers. Addressing a June 4 audioconference sponsored by FDANews and the Health Care Compliance Association, Farino said, “Companies are requiring a written letter of request designating the purpose of the grant, signed agreements that evidence an arrangement, and documentation of the appropriate approvals internally. There is no substitute for formalizing the process as a way of evidencing the fact that it has been separated — if not literally, then figuratively — from the sales operations.”

Of course, training will be critical in ensuring compliance. “This underscores the importance of training anybody in industry involved with CME in any way, shape, or form,” said Farino. Such training is “current on many sales force organizations' calendars for the next cycle.”

MECCs in the Hot Seat?

Farino also pointed out that the guidance says that “pharmaceutical manufacturers, as well as their employees and agents, should be aware of the federal anti-kickback statute.” When selecting a third party to handle CME development, Farino advised that manufacturers should make sure that the company has appropriate policies in place, “as well as ongoing reporting requirements so that you can monitor their activities.”

Passin observes that many major pharmaceutical companies have already started requiring written proof that communication companies have a nonpermeable firewall. This means MECCs need to make big structural changes; some are forming new companies, or are putting their promotion and education offices on different floors or in different buildings. They are making sure that “the decision-makers in the educational company are not also the decision makers in the promotion company,” says Passin.

But since the guidance says CME sponsored by medical professional organizations raises little risk of fraud and abuse, will industry avoid choosing MECCs as CME sponsors? “I suspect this caution may encourage some pharma companies to reconsider their support of educational activities sponsored by the more “commercial,” for-profit CME providers, and perhaps increase their collaboration with academic or non-profit accredited providers,” says Frederic S. Wilson, manager, CME, Procter & Gamble Pharmaceuticals, Mason, Ohio.

But others disagree. “I don't see why that should be, frankly,” says Bloch, “as long as the commercial CME provider is not itself linked to actual product purchasers, either physicians or hospitals, in some way. I don't think one can just broad brush and say commercial providers are somehow tainted.”

However, it is possible that pharma firms may be leery of funding hospital-based CME. Experts advise that pharma firms use caution when working with accredited providers that are also customers, for instance, hospitals' CME offices.

More Money for CME?

Of course, a major concern for CME providers is whether the OIG guidance will discourage pharma companies from funding CME. The consensus seems to be no. “If the government is looking for ‘a disguise for rewarding or inducing healthcare professionals,’ I'd look anywhere but at CME, since industry's financial grants are to accredited CME providers, not the healthcare professionals,” says Wilson. “Because other methods of communicating with the medical community will be under increased scrutiny, such as promotional dinner meetings and speakers bureaus, I expect funding to migrate to CME.”

Passin agrees. “We've seen indications that a lot of things are on hold; [firms are] waiting for answers to come down. Theoretically, it seems to us that [in the long run] more money will be put into legitimate CME.”

Continue Collaboration

Even if funding is not reduced, CME professionals do have concerns about the fallout from the OIG guidance. While separating CME from sales and marketing will have benefits, Saxton hopes that companies will not “go to the other extreme and become so hands-off that all they do is passively respond to requests for grants.”

Other CME experts agree. Field sales representatives often have an intimate understanding of the educational needs of the practicing physicians in their territory, and such information can be invaluable to CME providers, says Wilson. “Furthermore, pharmaceutical manufacturers have the ethical obligation to be the most knowledgeable about their products and convey that information to physicians.”

“The only way they can do that is to have an appropriate dialogue with the CME committee,” says Saxton. “They can't do it by passively giving grants and they can't do it through a purely market-share driven promotional agenda. There's an educational agenda that is entirely appropriate for them to pursue. I would hate for companies to interpret the OIG guidance to mean they can have no role whatsoever in education as it relates to accelerating the adoption of new innovations that are in the public's interest. That would be a tragedy.”

Protect Yourself

IN THE WEEKS FOLLOWING the OIG's issuance of its pharma guidance, several medical education companies received subpoenas from the Justice Department for all of their files relating to the investigation of a pharmaceutical company, says Steve Passin, president, Steve Passin & Associates, LLC, a CME consulting firm in Newtown Square, Pa. “While we do not expect that these providers will ultimately be held responsible in any way, these actions show that your documentation may be critical to these cases, you may be required to testify at hearings, and that you could be involved in such an investigation as an agent of the commercial supporter,” Passin warns.

He advises CME providers: “Know what you're certifying for credit; control the content-development process through the use of clinical specialists trained in the area of the activity; carefully review materials received from joint sponsors for content, not just process; and perform legitimate and thorough needs assessments that are well documented.”

Here are some more of his tips:

CREATE A PAPER TRAIL Don't assume your course director is protecting all of your interests. Have your CME committee assign a liaison to each project to make sure that the content is evidence-based and balanced, and that cited studies are scientifically accurate. Document this process, making it clear that there is a real need for the education and that it is not promotion in disguise, or a program that was requested by the supporter.

JOINT SPONSORSHIP If you are jointly sponsoring activities and another agency is doing the day-to-day planning, make sure you insert yourself in the process. Sit in on planning conference calls, or appoint a physician from your advisory committee to participate.

CLINICAL REVIEW Currently, many advisory committees act as a retrospective reviewer for the provider. Instead, assign members as liaisons to projects in development. Several of Passin's clients have developed a clinical review process, where activities in the early planning phase are sent to an expert contracted by the CME provider. For an honorarium, the expert reviews the materials, offering extra assurance that the activity is being planned in a balanced way.

NO MORE WINKS Stop checking with contributors during the planning process to get their approval. “That used to happen quite a bit. It was always done with a wink. The project manager would try to influence the content to reflect what the contributor wanted.”

PLAN AHEAD Rather than react to what the pharma salespeople suggest, have your advisory committees sit down, at least annually, to look ahead and brainstorm about CME initiatives.