Doctor Who Lost Job for Allegedly Prescribing Hydroxychloroquine and Ivermectin Investigated for COVID-19 Fraud
A doctor in Pennsylvania has lost her job and appears to be the target of a COVID-19 fraud investigation following allegations that she improperly provided off-label hydroxychloroquine and ivermectin prescriptions to patients exhibiting symptoms of SARS-CoV-2. According to reports, the doctor allegedly received referrals of patients who showed interest in these hydroxychloroquine and ivermectin and then provided prescriptions for these drugs as treatments for COVID-19.
As founding attorney Nick Oberheiden, Ph.D. recently told Fox43 News, “The government may make the claim that these patients were specifically recruited and assigned to a physician who without the appropriate due diligence if you will, was then essentially just rubber stamping approvals.”
While prescribing off-label medications is not inherently illegal, doctors and pharmacies that provide off-label prescriptions must be careful to ensure that they are meeting all pertinent requirements. Accepting patient referrals and providing prescriptions without a proper examination is prohibited in any circumstance, but it presents particular risks with off-label drugs. As a result, even if a physician or pharmacist is not at risk for prosecution as a result of providing an off-label prescription per se, he or she could still face prosecution for various other healthcare-related crimes.
What are the Rules Governing Off-Label Prescriptions?
The federal government defines an off-label prescription as follows: “Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition.” As the Agency for Healthcare Research and Quality (AHRQ) goes on to state, “This practice is legal and common. In fact, one in five prescriptions written today are for off-label use.”
Off-label prescribing allows physicians to make their own decisions about which drugs will benefit their patients. It allows physicians to sidestep the rigors of U.S. Food and Drug Administration (FDA) regulation, as off-label drugs, by definition, are not FDA-approved. While providing patients with off-label prescriptions can be risky from a malpractice perspective, many doctors are willing to take this risk if they believe that doing so is in their patients’ best interests.
But, when providing off-label prescriptions, doctors cannot simply throw out the rulebook. If anything, doctors must exercise extra caution to ensure that their prescribing practices comply with the law. Here is just a small sampling of the extraordinarily broad and dense body of legal authority governing off-label prescription practice:
- The Controlled Substances Act (CSA)
- The Food, Drug, and Cosmetic Act (FDCA)
- The FDA’s premarket authority to approve drugs for any use at all
- Federal drug branding laws and regulations (which prohibit “misbranding” of prescription drugs)
- Informed consent laws
- The Anti-Kickback Statute prohibition on improper financial relationships between pharmaceutical companies, pharmacies, and prescribing physicians
What is the Current Legal Status of Hydroxychloroquine and Ivermectin as Treatments for COVID-19?
Currently, neither hydroxychloroquine nor ivermectin has full FDA approval for treatment of COVID-19. Ivermectin is not approved at all, and hydroxychloroquine is only approved under an Emergency Use Authorization (EUA) in limited circumstances in the hospital setting. As a result, prescribing either of these drugs for COVID-19 treatment to outpatients is currently considered an off-label use.
Noting a “rapid increase” in ivermectin prescriptions last year, the U.S. Centers for Disease Control and Prevention (CDC) issued a Health Advisory stating:
“Ivermectin is a U.S. Food and Drug Administration (FDA)-approved prescription medication used to treat certain infections caused by internal and external parasites. When used as prescribed for approved indications, it is generally safe and well tolerated. . . . Ivermectin is not authorized or approved by FDA for prevention or treatment of COVID-19. The National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines Panel has also determined that there are currently insufficient data to recommend ivermectin for treatment of COVID-19. . . .”
As for hydroxychloroquine, the CDC currently states: “Evidence is insufficient to support treatment of COVID-19 with hydroxychloroquine (HCQ) and guidance from NIH recommends against its use.” In January 2022, the FDA clarified that:
“Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19. They are being studied in clinical trials for COVID-19, and we authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (or EUA).”
The FDA also wrote that it is “aware of increased use of [hydroxychloroquine] through outpatient prescriptions.” Again, while prescribing hydroxychloroquine off-label to outpatients is not necessarily prohibited, it presents significant legal risks for doctors and pharmacies that fail to ensure strict compliance with the law.
What are the Legal Risks of Prescribing Hydroxychloroquine or Ivermectin for COVID-19?
The legal risks associated with providing off-label hydroxychloroquine and ivermectin prescriptions for treatment of COVID-19 relate not only to the practice of off-label prescribing itself, but also to other aspects of physicians’ and pharmacists’ practices. When targeted in federal healthcare fraud investigations, physicians and pharmacists can face allegations including (but not limited to):
Violation of Off-Label Prescription Laws and Regulations
Given the state of the pandemic, the national media attention on hydroxychloroquine and ivermectin, and the potential health risks associated off-label use of these drugs, the FDA and other federal authorities are paying close attention to off-label prescriptions for COVID-19 treatment. If physicians and pharmacists are not taking all of the steps required to prescribe these drugs in full compliance with the law, they are at risk for being targeted in a COVID-19 fraud investigation.
Improper off-label prescribing potentially violates the CSA, FDCA, and a host of other federal laws and regulations. While some investigations will be civil in nature, many will present risks for criminal prosecution. Physicians and pharmacists accused of improperly providing off-label prescriptions of hydroxychloroquine and ivermectin for COVID-19 treatment can potentially face licensing action as well.
Improper Referral Fees and Other Financial Relationships
Even if an off-label prescription is lawful, the doctor who writes the prescription can still face civil or criminal enforcement action related to improper referral fees or other financial relationships. The same is true of entities that refer COVID-19 patents to doctors who prescribe hydroxychloroquine and ivermectin, and of pharmacies that fill these off-label prescriptions for patients.
Along with closely examining off-label hydroxychloroquine and ivermectin prescriptions, federal authorities are also scrutinizing the financial relationships between those involved. If the U.S. Department of Justice (DOJ) cannot prosecute a doctor for writing an off-label prescription for a non-FDA approved COVID-19 treatment, it may still be able to prosecute the doctor for violating the Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, or Stark Law.
Prescribing Medications Without Proof of Medical Necessity
In the case discussed above, one apparent issue seems to be the doctor’s alleged failure to properly examine patients before prescribing off-label hydroxychloroquine and ivermectin. Once again, while this is not an issue that is unique to COVID-19 treatment, it is an issue that is subject to intense federal scrutiny in hydroxychloroquine and ivermectin-related investigations.
To write a valid off-label prescription, a physician must determine that off-label use of the prescribed drug is appropriate to meet the patient’s specific needs. Without an examination, this determination cannot be made. If a doctor’s records show that he or she has prescribed hydroxychloroquine or ivermectin to patients without conducting an appropriate exam and confirming a possible COVID-19 diagnosis, this will very likely result in federal enforcement action.
Improperly Billing Medicare, Private Insurers and Other Payors for Off-Label Drugs
Doctors who prescribe hydroxychloroquine and ivermectin for the treatment of COVID-19 can also face legal issues related to their billing. As the Center for Medicare Advocacy explains, “Medicare Part D covers drugs prescribed for off-label use only if the drugs are identified as safe and effective for that use [by CMS].” CMS does not currently identify hydroxychloroquine or ivermectin as safe and effective for treating COVID-19. As a result, if doctors bill Medicare for prescribing off-label hydroxychloroquine or ivermectin, they can face liability under the False Claims Act and other laws for Medicare fraud.
Improperly billing private insurers for off-label prescriptions is also a form of federal healthcare fraud. So, if a provider improperly (or “falsely”) bills an insurance company for hydroxychloroquine or ivermectin, the provider can face federal enforcement action in addition to facing civil liability in litigation with the insurer.
In light of the continued media coverage of the off-label use of hydroxychloroquine and ivermectin for treating COVID-19 and the federal government’s focus on combatting pandemic-related healthcare fraud, we expect to see many more cases like the one discussed above. Providers that prescribe these drugs should promptly reassess their compliance programs, and those targeted in federal investigations should engage experienced defense counsel immediately.
Speak with a Federal Healthcare Fraud Defense Lawyer at Oberheiden P.C.
If you need to know more about the laws governing the off-label prescription of hydroxychloroquine and ivermectin for treating COVID-19, we encourage you to get in touch.
Our attorneys also represent clients in need of qui tam and healthcare fraud defense, involved in federal investigations, facing federal criminal charges, and in other legal matters. To schedule a confidential consultation with a federal fraud defense lawyer at Oberheiden P.C., please call 888-680-1745 or inquire online now.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.