Today’s case doesn’t involve prescription drugs or medical devices. But it is a circuit court opinion that we thought warranted bringing to the attention of our readers who deal with False Claims Act (“FCA”) claims. We’ve discussed FCA claims as an “awkward vehicle” in pharmaceutical cases here and we hold true to that belief. But, as we all know qui tam plaintiffs (relators) try to append the FCA to allegations of off-label promotion of prescription drugs. The allegations typically go something like this – pharmaceutical company engaged in a nationwide “scheme” to promote its drug off-label, doctors therefore prescribed it off-label, and then the pharmacies filed claims with the government for those off-label prescriptions. Putting aside that typically plaintiffs cannot sufficiently allege a connection between the alleged off-label promotion and any claim made to the government – where’s the “objective falsehood” that is the touchstone of an FCA claim.
Well, that was precisely the question before the Eleventh Circuit in United States v. Aseracare, Inc., — F.3d –, 2019 WL 4251875 (11th Cir. Sep. 9, 2019) in the context of claims for hospice care. In order for a hospice claim to eligible for Medicare reimbursement, the attending physicians must certify based on the doctor’s “clinical judgment regarding the normal course of the individual’s illness” that the individual is terminally ill. Id. at *2. Terminally ill means that the patient’s life expectancy is 6 months or less. Id. That does not mean that if a patient survives for longer than 6 months, they are no longer eligible for hospice care under Medicare. The regulations take into consideration that “predicting life expectancy is not an exact science.” Id. Patients can improve, they can be removed from hospice and return to hospice, they could simply survive longer than anticipated. So there are also recertification periods every 60 to 90 days to remain on hospice. There are not set criteria for determining whether a patient is terminally ill, but there are guidelines. The bottom line is that the treating physicians are required to review all the medical information concerning the patient and user their best clinical judgment to reach a conclusion regarding whether a patient is terminally ill. While the regulations may be different, the underlying premise is very similar to a physician using his/her clinical judgment to decide whether to prescribe a medication to a patient for an off-label purpose.
Plaintiffs in the present case alleged that defendant, a collection of hospice care providers, “submitted documentation that falsely represented that certain Medicare recipients were terminally ill when in the Government’s view they were not.” Id. at *3. Again, sounds similar to a claim that prescriptions were falsely submitted for off-label uses that in the government’s view were not medically necessary. The key words being “in the government’s view.” The government was not alleging that the certifications by the treating physicians weren’t supported by the underlying medical records or by the physician’s own clinical judgment. Just that the government didn’t agree with the treating doctor’s conclusion.
The case proceeded to trial because at the summary judgment stage, the trial court was unwilling to adopt a “reasonable doctor” standard. Id. at *5. At trial, the government’s expert testified that based on his review of the records, it was his medical opinion that the patients had life expectancies of greater than 6 months. The government’s expert conceded, however, that “his testimony was a reflection of only his own clinical judgment based on his after-the-fact review of the supporting documentation.” Id. at *6. Moreover, the government’s expert did not testify that no reasonable doctor would have concluded that the patients were terminally ill. Id.
After a jury verdict in favor of plaintiff, on defendant’s post-trial motions, the court determined that it erred in not instructing the jury that proof of an “objective falsehood” was a necessary element of an FCA claim and that “a mere difference of opinion between physicians, without more, is not enough to show falsity.” Id. at *8. The Eleventh Circuit agreed.
The government’s primary argument against a narrow reading of what constitutes a falsity under the FCA was that hospice care would be eligible for reimbursement for anyone who finds a physician to sign the certification. Id. at *13. But that overlooked that the certification still had to be based on the physician’s clinical judgment informed by the patient’s medical records. Nothing in the court’s ruling required that every claim for hospice care had to be reimbursed without review by the government. The government is still free to challenge any claim it believed was not “reasonable and necessary” under the regulations. For instance, if the government had proof that the certifying doctor didn’t review the patient’s medical records or if the government proved that no reasonable doctor who have found the patient terminally ill. Id. at *15. What it cannot do is use after the fact, secondary opinions to contradict first-hand, fully-informed, reasonable medical decisions by patient’s physicians. Just as the regulations provide – life expectancy is a not an exact science. So, it is not difficult to believe that two doctors could disagree – and neither be wrong. Maybe because this is something we’ve lost sight of in general society, it warrants repeating. Two people can hold different opinions and neither person is wrong. It may be equally accurate to say neither person is correct either. That’s why we call it an opinion. It’s a person’s or people’s view or judgment. We talk about opinions every single day on this blog. They are the views of a single judge or a particular court as to what the law is. Sometimes we don’t agree with them. Sometimes we even accuse them of getting it wrong. But that’s just our opinion too.
In medicine, a doctor renders an opinion about medical care. It needs to be an informed opinion to be valid, but it’s still an opinion nonetheless. He/she needs to use his/her medical knowledge and the knowledge of his/her patient to reach a learned conclusion. But it is still an opinion subject to individualized interpretation. That’s why people get second opinions for major medical decisions. But if your second opinion differs from your first, was your first doctor wrong or the second doctor? In either event, neither was lying to you. Neither stated an “objective falsehood.” That’s why the government didn’t have an FCA claim in this case.
[A] reasonable difference of opinion among physicians reviewing medical documentation ex post is not sufficient on its own to suggest that those judgments—or any claims based on them—are false under the FCA. A properly formed and sincerely held clinical judgment is not untrue even if a different physician later contends that the judgment is wrong.
We think this should apply to FCA claims involving allegedly medically unnecessary off-label uses. There is no law against doctors prescribing drugs or using devices off-label if they are using their own independent medical judgment and doing what they believe to be in the best interests of their patients. So, an FCA claim premised on off-label promotion supported by nothing more than plaintiff’s experts disagreeing ex post with the reasoned judgment of patients’ doctors shouldn’t hold up using the reasonable doctor standard adopted by the Eleventh Circuit.