CME and sponsored symposia: rules for health companies

Medical meetings give a health company two very different ways to reach clinicians. It can fund education that someone else designs and runs, or it can run its own program: a sponsored symposium, a product theater, a dinner talk. Both can be lawful. The trouble starts when a company pays for the first and behaves as if it bought the second, because then the “independent” education is treated as company promotion, with everything that follows from that.

This guide is for drug, device, diagnostics and health tech companies, and for the agencies that plan meetings for them. It covers the line between independent education and promotion, the grant process, Open Payments for faculty, and what a company-run symposium can say. Exhibit booths are covered in our separate guide to trade show marketing, and paid speaker programs in our Open Payments guide.

The short version

• Decide first which kind of program it is. Independent education is designed by the provider; a sponsored symposium is your promotion. Mixing the two is where most problems come from.
• If you fund education, give up control. FDA’s 1997 guidance looks at who controls content and picks speakers, what is disclosed, how balanced the program is, who chose the audience and whether sales staff were involved.
• Keep grants away from sales. OIG advises manufacturers to separate grant making from sales and marketing, to use objective criteria that ignore purchase volume, and to have no control over the speaker or content.
• A company-run symposium is advertising. It has to stay within the approved or cleared uses, with fair balance, and the speakers you pay are reportable in Open Payments.
• Faculty payments can be reportable even when they pass through a provider, if your company causes the payment to reach a known physician (42 CFR 403.902, 403.904(h)(1)).

Two kinds of program, two sets of rules

Most conferences offer both formats side by side, and the agenda often prints them in the same font. For a company, they sit in different legal categories:

• Independent, often accredited, education. A medical society, university, hospital or education company plans the activity, picks the topics and faculty, and may award continuing education credit. Your company can support it with a grant, but the content belongs to the provider.
• Company-run programs. Satellite symposia, product theaters, lunch talks and speaker dinners where your company chooses the topic, the speaker and the slides. These are promotional, and the provider’s accreditation does not cover them, even if the meeting itself is accredited.

FDA has said it has not regulated, and does not intend to regulate, industry-supported activities that are independent of the supporting company’s promotional influence under the labeling and advertising provisions of the law. The flip side is that a supported activity the company does influence can be treated as the company’s own promotional labeling or advertising. So the question for every program is not what it is called, but who actually shaped it.

What FDA looks at to decide whether education is independent

The 1997 final guidance lists factors FDA will consider when it asks whether a supported activity is independent. It is old, but it has not been withdrawn, and the factors still map well onto how companies get into trouble:

• Control of content and selection of presenters and moderators. The provider should decide both. The guidance says a supporting company should not script, target points for emphasis, or otherwise try to influence the content. It adds that a company suggesting presenters from its own paid promoters or marketing consultants may be seen as an attempt to influence the program, and that disclosure cannot cure that.
• Disclosures. The audience should be told about the company’s funding, about significant relationships between the provider, the presenters and the company, and, when unapproved uses are discussed, that fact.
• Focus of the program. A program centered on one company’s product, with other reasonable options left out or played down, is a warning sign. So is a title that suggests a broader topic than the program covers.
• Relationship between provider and company. Legal, business or other ties between the provider and the company can put the company in a position to influence content.
• Provider involvement in sales or marketing. A provider that also advises or helps with the sales or marketing of the company’s product is harder to treat as independent.
• Multiple presentations. Repeating a program is not wrong, but a company that sees the first one and then decides whether to fund more has an obvious lever over content.
• Audience selection. FDA says it views company involvement in choosing or inviting the audience as undermining independence, including sales representatives handing out invitations or sales-driven lists of high prescribers or “opinion leaders.”
• Opportunities for discussion, such as question time, and dissemination after the event, such as company distribution of recordings, also count.
• Ancillary promotion. No promotional material or activity in the room where the education takes place.

A written agreement between company and provider is not required by the guidance, but FDA describes it as one way to document how independence was kept. In practice it is the first thing anyone asks for.

Educational grants and the Anti-Kickback Statute

The federal Anti-Kickback Statute makes it a crime to knowingly and willfully offer or pay any remuneration to induce someone to refer patients, or to purchase, order or recommend items or services paid for by a federal health care program (42 USC 1320a-7b(b)). A grant, a free registration or a paid trip to a meeting can be remuneration.

OIG’s 2003 Compliance Program Guidance for Pharmaceutical Manufacturers addresses educational grants directly. In its words, manufacturers “should separate their grant making functions from their sales and marketing functions,” set objective criteria that do not take into account the volume or value of purchases by the grant recipient, and “should have no control over the speaker or content of the educational presentation.” It warns that funding conditioned on product purchases implicates the statute even if the educational purpose is legitimate.

The same guidance says that CME with no industry sponsorship, financing or affiliation should not raise anti-kickback concerns, but that a manufacturer paying tuition for physicians or medical students may. It also tells manufacturers who fund other CME sponsors to make sure the activity is not used to channel improper payments to people who can generate business, or to steer content. The guidance was written for drug makers, but device and diagnostics companies face the same statute, and OIG’s reasoning carries over.

A grant process that holds up usually looks like this:

1. Requests come in through a written application, not through a sales representative or a regional manager.
2. A grants or medical team decides using published criteria such as educational need and quality, with no input from sales on who gets funded.
3. The agreement states the provider controls content, faculty and audience, and lists what the company may and may not do.
4. Payment goes to the provider, never to individual faculty or attendees.
5. The company keeps records: the request, the decision, the agreement, the final program and the reconciliation of how funds were spent.

Sponsoring a whole event or a society’s program raises related questions, covered in our guide to sponsorships and naming rights.

Accreditation standards: what providers will ask of you

Accredited continuing medical education in the United States is overseen by the Accreditation Council for Continuing Medical Education (ACCME), whose Standards for Integrity and Independence in Accredited Continuing Education govern how accredited providers handle industry. Summarized in our own words, they ask providers to:

• make all decisions about the education without the involvement of companies that make or sell products used on patients, which the standards call ineligible companies;
• collect financial relationship information from everyone who controls content, identify relevant relationships, mitigate them and disclose them to learners;
• keep marketing, advertising and exhibits separate from the education itself;
• handle any commercial support under a written agreement, with the provider in control of how the money is used.

Expect a provider to send you its own agreement and to refuse requests for slide review, speaker suggestions or attendee lists. That is the system working, not the provider being difficult. Other health professions have their own accreditors with comparable rules, so check which one applies to the activity.

Running your own symposium or product theater

When your company is the organizer, the program is promotion and should be planned as promotion from the start:

• Label it clearly. The program, the signage and the invitation should say the company is presenting it and that it is not accredited education.
• Stay within the label. For drugs, FDA’s advertising and labeling rules require claims consistent with the approved labeling and fair balance of risks (21 CFR 202.1); for devices, a promoted use outside the clearance can become an intended use (21 CFR 801.4). Speakers you pay are presenting for you, so their slides go through your promotional review.
• Prepare speakers for off-label questions. Decide in advance how unsolicited questions about unapproved uses will be handled, for example by referring them to medical information rather than answering from the podium.
• Meals and travel are reportable. Food and drink at a company-run program, and speaker fees and travel, are payments to covered recipients that fall under Open Payments when they reach the thresholds.
• Watch the cost and the guest list. OIG’s speaker program concerns (lavish venues, repeat attendees, attendees with no educational need, high prescriber targeting) are covered in our Open Payments guide.

Recording a symposium and posting it online turns a live program into a lasting asset with its own review needs; see our guide to healthcare podcasts and webinars.

Open Payments for faculty, grants and attendees

Applicable manufacturers report payments and other transfers of value to physicians and other covered recipients under 42 CFR 403.904. Among the reporting categories are “compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program” and “compensation for serving as faculty or as a speaker for a medical education program” (403.904(e)(2)(ii) and (xiv) in the current list). Choose the category that fits the program.

Grants paid to an education provider raise the indirect payment question. Under 42 CFR 403.902, an indirect payment is one a manufacturer makes through a third party where the manufacturer “requires, instructs, directs, or otherwise causes” the third party to pass the payment to a covered recipient. Indirect payments are excluded from reporting only when the manufacturer does not know the recipient’s identity during the reporting year or by the end of the second quarter of the following year (403.904(h)(1)). So a grant that leaves faculty choice and pay entirely to the provider sits differently from one where your company names the speaker or earmarks money for a particular physician. Your Open Payments team should see every grant agreement.

Covering registration, travel or hotel for physicians to attend a meeting is a direct transfer of value to each of them, with the anti-kickback questions noted above.

Booths, posters and the education space

Your booth sits in the exhibit hall, where promotion is expected. The education space is different: no product material in session rooms, no sales staff working the line for an accredited session, no branded items on the chairs. Scientific posters and abstracts presented by your employees or funded investigators are a gray area; when they report data on unapproved uses, have your medical and regulatory teams decide in advance who staffs them and how questions are answered. Our white paper guide covers fair citing of study data, and the device claims guide covers cleared versus approved wording.

Illustration: one product launch, two meeting plans

A hypothetical device company is launching at a national specialty meeting. In the first plan, marketing applies for an accredited session on the condition the device treats, offers a list of “good speakers” who are also on its paid speaker roster, asks to review the slides, and has sales representatives invite high-volume physicians. Each of those steps is one of FDA’s independence factors pointing the wrong way, and the session would likely be treated as company promotion delivered under an educational label.

In the second plan, the company does two separate things. Its grants team funds the society’s education program through the society’s open application, with no say over topics or faculty, and its Open Payments team reviews the agreement. Separately, marketing runs a clearly labeled evening product theater with a paid speaker, slides that went through promotional review and stay within the cleared indications, a modest meal that is tracked for reporting, and invitations sent by the company in its own name. Both programs are legitimate because each is what it says it is.

Checklist

• Each program is classified up front as independent education or company promotion, in writing.
• Grant requests go through a written application to a team that does not report to sales.
• Grant criteria are published and ignore the recipient’s purchases or prescribing.
• No company input on topics, speakers, slides or audience for supported education.
• Grant agreements say who controls content, and Open Payments reviews them.
• Company-run programs are labeled as such, stay within approved or cleared uses and go through promotional review.
• Speaker fees, travel and meals for covered recipients are captured for reporting.
• No company material or sales activity in accredited education rooms.
• A plan exists for off-label questions at symposia, booths and posters.

How we help

We build lead generation and event marketing for health companies, including symposium invitations, follow-up sequences and landing pages, with a source file for every claim and a clear line between promotion and education. See our approach to healthcare lead generation, or browse more guides in Insights.

Sources

• FDA: Final Guidance on Industry-Supported Scientific and Educational Activities, 62 FR 64074 (December 3, 1997)
• OIG: Compliance Program Guidance for Pharmaceutical Manufacturers, 68 FR 23731 (May 5, 2003)
• 42 USC 1320a-7b: Criminal penalties for acts involving Federal health care programs
• 42 CFR 403.902: Definitions (Open Payments)
• 42 CFR 403.904: Reports of payments or other transfers of value to covered recipients
• 21 CFR 202.1: Prescription-drug advertisements
• 21 CFR 801.4: Meaning of intended uses
• ACCME: Standards for Integrity and Independence in Accredited Continuing Education (summarized, not quoted)

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