In several press conferences the President of the United States has been promoting the use of a malaria drug, Chloroquine, for treatment related to COVID-19. Because Chloroquine is not approved for COVID-19, the prescribing and dispensing of that medication for COVID-19 is what is described as off-label. It is the position of CMS however, that the promotion of the use of pharmaceuticals for unapproved symptoms or conditions, in unapproved patient groups, or in unapproved dosages, off-label use, is subject to the False Claims Act. Although most actions by CMS have been brought against manufacturers promoting off-label uses as opposed to individual practitioners and pharmacies prescribing and dispensing those medications, CMS may not pay for some of those medications. Also, and very importantly, as is the case with all medical practice, a physician prescribing and a pharmacy dispensing an off-label medication runs a substantial risk that if the treatment goes wrong, they are subject to potential malpractice liability.
Physicians are permitted to prescribe medications for off-label uses and pharmacies may dispense those medications. Studies have shown that as many as one in five prescriptions written in the United States is for an off-label usage even though a many of those off-label usages have little or no scientific support. The issue for CMS is whether a medication has a “medically accepted indication,” generally an FDA approved use or one which has been peer reviewed by a journal approved by the Secretary of CMS. Because Part D and private health insurance is subject to the policies of individual plans, patients and pharmacies run the risk of denials of claims for off-label uses of drugs based upon those policies without prior authorization. In many cases initial approvals can be retroactively clawed back if a carrier determines the medication does not meet its criteria.
Even while testing in other countries has indicated a possible efficacy for the use of Chloroquine in treating COVID-19, manufacturers have been going out of their way to make sure the public understands that Chloroquine is not approved for COVID-19. The drug itself has been publicly available for 70 years and has been found to be safe with few side effects. However, the manufacturers are keenly aware of the potential liability, both from a malpractice perspective as well as a false claims and FDA perspective. It is an interesting legal argument whether one should be liable for President promoted drug and in somewhat desperate times Congress is allowing immunity for legal liability for a range of COVID-19 related actions. However, that does not currently amount to authority to do so and physicians and pharmacies should be cautious.
Written by: Bernard M. Cassidy, Esq.
Bernard M. Cassidy, Esq. is an attorney specializing in health law, health law regulatory and white-collar criminal defense.