Last year the HHS Office of Inspector General issues a “Special Fraud Alert” (“Alert”) concerning “Speaker Programs” – more usually known as continuing medical education (“CME”).  Since we believe that truthful commercial speech is First Amendment protected, seeing “fraud” bandied about like this caused us to take a look.  We’re well aware that for years the FDA has pursued Orwellian logic to declare truthful speech (including CME) about off-label uses to be “false and misleading,” so we decided to see if the HHS OIG was going down the same regulatory primrose path.

To be clear, what this is all about is manufacturer-sponsored lectures to physicians about current medical issues at which the attendees receive free food:

[S]peaker programs are generally defined as company-sponsored events at which a physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.  The company generally pays the speaker HCP an honorarium, and often pays remuneration (for example, free meals) to the attendees.

OIG Alert, at page 1.

Fortunately, this alert – unlike FDA’s activities – seems directed more at the money involved (OIG mentions $2 billion over three years, id.) than the content of the presentations.  Focus is paid to large amounts of money paid to “high prescribing” speakers.  Id.  To some extent we think this is a bad rap, when one considers the educational purpose of CME.  It’s highly likely that whatever the product might be, physicians who use it most frequently are likely to be the most familiar with its risks and benefits, and thus would be the most educational speakers.  These sorts of payments to physicians, moreover, are already reportable and publicly available.

So-called “high prescribers” are also likely to be quite busy, and since “time is money,” they must be paid to spend time away from their lucrative practices.  So what OIG portrays as “fraud” may well be nothing more than simple statistical association.  That’s why “fraud” in litigation requires “scienter.”  “Scienter,” in a fraud case, means “a mental state embracing intent to deceive, manipulate, or defraud” – “intent to defraud, reckless disregard for the truth, or knowing use of some practice to defraud is necessary in such an action.”  Ernst & Ernst v. Hochfelder, 425 U.S. 185, 193 n.12 (1976) (requiring scienter in securities fraud cases).  Indeed, the OIG alert states flatly that, “[t]he anti-kickback statute makes it a criminal offense to knowingly and willfully solicit, receive, offer, or pay any remuneration to induce or reward, among other things, referrals for, or orders of, items or services reimbursable by a Federal health care program.”  Id. (emphasis added).

The more specific the OIG’s alert gets, the less problems we have with it.  “[C]ondition[ing] speaker remuneration on sales targets,” id. at 2 – above a minimum necessary to maintain competency and familiarity, that sounds like the kind of thing the Anti-Kickback statute was intended to prevent.  Programs held “in a manner not conducive to an educational presentation,” id. – ditto, that’s not CME, albeit an issue directed more to audience than speaker behavior.  Programs held at “high-end restaurants where expensive meals and alcohol were served,” id. – we’re more supportive of OIG concerning the alcohol (again, directly detracting from CME), than the food, but at the extreme the OIG cited (“over $500” a head), the need to induce CME attendance has been overshot.  Invitees “who had previously attended the same program,” or friends and family “who did not have a legitimate business reason to attend,” id. – the purpose of CME is education, and this example also does not serve that purpose.

We do take umbrage at the Alert’s general statement that “OIG is skeptical about the educational value of such programs.”  Id. at 3.  First of all, that’s not its job.  Its job is to enforce the law with respect to federal programs – not to evaluate content.  That’s precisely where the FDA has gotten in trouble with the First Amendment.  As stated above, we have no problem with most of the red flags that its Alert identified.  But OIG is not a medical society, and its personnel are not doctors.  It should enforce the law, as it describes, but should not become a “nanny state” devoted to telling medical professionals how and where they should be obtaining their CME.  Thus we think the Alert overreaches when it purports to do just that:

There are many other ways for HCPs [health care providers] to obtain information about drug and device products and disease states that do not involve remuneration to HCPs.  HCPs can access the same or similar information provided in a speaker program using various online resources, the product’s package insert, third-party educational conferences, medical journals, and more.

Alert at 4.

OIG’s bureaucrats should resist this temptation to play doctor.  OIG should do its job and allow medical societies and state medical boards to do theirs.  If a doctor or someone else with power over prescription choices “knowingly and willfully soliciting or receiving remuneration in connection with speaker programs in return for prescribing or ordering products,” id. at 5, then prosecute them.  But the OIG’s generalized observations about how doctors should obtain CME ignore the scienter requirements of the Anti-Kickback Act, and thus exceed OIG’s authority.  For that reason we also object to two of the “suspect characteristics” that the Alert lists:

The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information.

There has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product.

Alert at 5.  Both of these items involve OIG purporting to make prosecutorial decisions based on the substantive content of CME programs.  “Topic”-based restrictions on speech are violations of the First Amendment.  E.g., Reed v. Town of Gilbert, 576 U.S. 155 (2015).  Nor is the restriction to “new” information appropriate, since there are always new doctors.  This sounds like the FDA’s “changes being effected” regulation.  Further, the focus on “new FDA-approved or cleared indications,” ignores that much cutting edge medicine – such as every extant COVID-19 treatment – involves off-label uses.  CME about off-label uses may well be more important and valuable to its intended audience than CME about labeled uses, since as OIG pointed out above, the “package insert” is a good source of information about the latter.