Although they have nothing to do with the Affordable Care Act, health-care-related so-called “death panels” do exist. These panels are operated by state agencies and private health insurance companies, and they decide whether to reimburse as “medically necessary” (or some similar definition) any type of medical care that comes into question. They’re an unfortunate necessary – quackery should not be reimbursed. But such panels used to reject any form of off-label use, until states and the federal government passed laws and regulations telling them that they couldn’t. As we’ve explained elsewhere, off-label use can frequently represent the medical standard of care.
But in Harborth v. State, ex rel. Dep’t of Workforce Services, ___ P.3d ___, 2018 WL 4011635 (Wyo. Aug. 22, 2018), we ran into one of the limits to those protections – and to off-label use – that we haven’t seen in a published opinion in quite some time. Something isn’t “off-label” when there is no FDA-approved label at all. The Wyoming Supreme Court affirmed a coverage denial of therapy involving the implantation of a medical device that had never been approved by the FDA for labeling and marketing for any intended use whatsoever.
How could that happen?
The FDA only regulates prescription medical products in the United States. In Harboth, the claimant had a history of chronic back problems. Ultimately the state worker’s compensation panel approved a rather expensive and involved surgical procedure:
a foraminotomy at L4-5 and transforaminal lumbar interbody fusions (TLIF’s) at both L5-S1 and T12-L1. [Claimant] testified that [the recommended] surgery would cost approximately $400,000.
2018 WL 4011635, at *1.
Before agreeing to cover this surgery, the state required “two peer reviews.” Id. That took some time, and in the interim, the claimant got cold feet. Id. at *2. She was also in “excruciating pain” waiting for worker’s comp. to make up its mind. Id. at *3. The claimant investigated various treatments for her condition online, and learned about “artificial disc replacement surgery using the ‘M6’ artificial disc.” Id. The surgeon who performed this procedure was in Germany. The claimant crossed the pond and had the surgery. Not only was it “successful,” but it cost a fraction of the $400,000 that the “death panel” was prepared to pay for the other type of surgery. Id. at *4 (surgery was “appeared to be a success”), *10 (“surgery cost $340,000 less than [the initially proposed] procedure”).
The state’s version of a “death panel” nonetheless “denied compensation for the surgery, finding that it was not reasonable and necessary medical treatment.” Id. at *3.
Because it could. The relevant reimbursement guidelines authorized payment for “off-label use,” but the M6 device had only received governmental approval for use in the European Union, and not from the FDA. Id. at *3 (“there has been no United States FDA approval of the M6-L disk replacement system”).
If the surgery had really been “off-label use” (ironically, a basis for the denial of the claim by the panel), then the claimant may have had a chance:
Rules recognize optional approaches to verifying that a procedure or device lacking FDA approval is reasonable and necessary. . . . For “off-label use of medical services,” the health care provider must submit a comprehensive review of the medical literature supporting the off-label use, including “at least two (2) reliable prospective, randomized, placebo-controlled, double-blind trial[s].”
Harborth, 2018 WL 4011635, at *5 (citations to various rules omitted).
But the procedure had to involve “off-label use” in order to fit under these rules. “‘Off-label use of medical services’ is defined as: ‘Medications, treatments, procedures or other medical services used for other than the approved Food and Drug Administration (FDA) indications.’ Id. at *6 (citation and quotation marks omitted). Off-label use is OK:
[O]nce the FDA has cleared a device for introduction into the stream of commerce, physicians may use the device in any manner they determine to be best for the patient, regardless of whether the FDA has approved the device for this usage. This practice by physicians is known as “off-label” usage.
Id. (citation and quotation marks omitted). But for the use of a device to be “off-label,” that device must first have been approved for marketing and labeling by the FDA for something. The M6 wasn’t:
“[O]ff-label” medical service [i]s one that deviates from a use that has been approved by the FDA. . . . Under . . . the Division Rules, the plain definition of “off-label” use does not encompass the surgical implantation of an M6 artificial disc adjacent levels. The M6 artificial disc is not approved for any use by the FDA. Thus, there is no “label” from which a medical provider may deviate.
Id. (citations and quotation marks omitted) (emphasis added).
Because the rules and regulations under which the state’s workers compensation system operated were “clear and unambiguous” in defining off-label use, nothing else mattered. It didn’t matter that the claimant appeared to have a better prognosis (she returned to work, which was questionable under the other surgical alternative). It didn’t matter that the surgical option the claimant pursued saved the state hundreds of thousands of dollars.
[Claimant] urges us to consider the success of her surgery as documentation of its safety and effectiveness. . . . [I]t may be tempting to weigh the actual outcome of surgery into the determination of compensability. Because [she] underwent surgery costing $340,000 less . . . and returned to her previous work duties with no restrictions and no pain medication, the evidence of her outcome is especially compelling. However, . . . it would be unreasonable to view the outcome of a medical procedure as a factor that trumps all others. [The] . . . Rules do not award compensation for medical treatments only if they are “successful” . . .; instead, in order to receive medical benefits, a claimant must show that his treatment is “reasonable and necessary.” A patient might fail to respond to reasonable and necessary medical treatment; and, likewise, a patient may benefit from elective, “unnecessary” medical treatment.
Id. Anecdote, unfortunately for this claimant, is not data. “A claimant’s successful surgery is only a single instance of success, and is not a substitute for objective and verifiable medical data demonstrating the procedure’s overall record for safety and effectiveness.” Id.
It’s been a long time since we’ve seen a court draw this distinction. In Gaston v. Hunter, 588 P.2d 326, 330 (Ariz. App. 1978), the court held that informed consent rules applicable to off-label use do not apply to an “experimental” medication that had not yet received FDA approval for anything, and was still under clinical investigation. Similarly, in Retkwa v. Orenteich, 584 N.Y.S.2d 710 (N.Y. Sup. 1992), it was not off-label use to employ “liquid injectable silicone” in surgery where the material was not being sold as a medical device at all (a prior opinion in the same case called it “non-medical grade”). “It is a reasonable assumption that most patients, confronted with a doctor’s recommendation for injection of a foreign substance, presume that such substance has been the subject of official testing, consideration, and approval.” Id. at 712 n.6.
Whatever ones opinion of the third-party payor would-be “death panels,” and whether or not the “ends” in Harborth should have justified the means, the decision is a reminder that not everything that doctors do with FDA-regulated prescription medical products fits neatly into the two categories of “labeled use” (called “intended use” by the FDA) and “off-label use.” With the Internet making ever more medical information (and disinformation) available without regard to national borders, we would not be surprised to encounter more cases where the distinction drawn in Harborth is relevant.