This post is from the non-Reed Smith side of the blog.
Occasionally, a qui tam action grabs our attention. Usually because it would seek to penalize off-label use. Anything that shuts that down deserves a mention here.
Qui tam plaintiffs seek damages under the False Claims Act based on allegations that a defendant caused the submission of false claims to the government. In some cases, plaintiffs have tried to turn allegations of off-label promotion into false claims cases, such as United States ex rel. Colquitt v. Abbott Labs, 2016 U.S. Dist. LEXIS 1556 (N.D. Tex. Jan. 7, 2016). The case involves vascular stenting procedures in which biliary stents were used – off-label. Id. at *4.
Plaintiffs’ off-label use argument goes like this. Under the Medicare Act, to be reimbursed, the device must be “reasonable and necessary” for diagnosis or treatment. Id. at *9. To qualify as “reasonable and necessary” the device “must be affirmatively determined by the [FDA] to be safe and effective.” Id. at *9-10. Because the FDA has not determined the safety and effectiveness of the off-label use to which the device was put, the device is not eligible for Medicare coverage. Id. at *10. So essentially, plaintiffs’ theory is a ban on off-label use where government health insurance is involved. Plaintiffs want the court to say that off-label use is across the board “not reasonable,” “unnecessary,” and/or “experimental.” As we’ve seen time and time again, however, off-label use is often the standard of care. Medicine leads, regulations follow.
Fortunately, the court rejected plaintiffs’ extreme position that FDA safety and effectiveness determinations are dispositive on Medicare eligibility. The FDA’s review of a device is a not a “substitute” for an insurance eligibility determination. Of more significance, “lack of FDA approval or clearance for a specific use does not categorically disqualify a device from Medicare coverage.” Id. at *13. Maybe it was plaintiffs’ complete overreaching that made this such an easy call for the court. Maybe it was the growing precedent for this proposition (cited in Colquitt). Either way, it’s an important holding from the case.
The rest of the case is more nuanced about Medicare claims and ultimately the court denied both parties’ summary judgment motions finding disputed facts on both sides. So, if you’re a qui tam person, you might want to take a peek at the whole decision. If you’re not, the take away is yet another attempt to criminalize off-label use is thwarted.