Pharmacy ALERT: Prime Therapeutics Raises Its Standards on Off-Label Claims

Recently, Prime Therapeutics (Prime) announced that its member pharmacies should only dispense prescriptions with dosage strengths and routes of administration that are consistent with manufacturer prescribing information. Prime also now further requires that the pharmacies should anticipate providing scientific evidence demonstrating the efficacy and safety of the prescriptions. Such onerous document requests by Pharmacy Benefit Managers (PBMs) have been prevalent with respect to Medicare Part D claims. In fact, it is often the case where PBMs chargeback the entire amount of Medicare Part D claims after the pharmacy having dispensed the medications to the patients. Prime’s announcement insinuates that it will start implementing the same egregious and abusive audit chargeback on commercial claims. This means that the pharmacies may face significant challenges and obstacles when seeking to fill and dispense “off-label” prescriptions. Such restriction is wholly inconsistent with the practice of medicine and practice of pharmacy, and may also violate several state laws.    

Approximately 20% of all prescriptions in the United States are for off-label use according to several studies. Medications that are used in their “unintended” capacity and outside of their FDA-approved indicated usage may not have readily available scientific evidence supporting exactly how the medication was prescribed. Even the FDA has stated that “[g]ood medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgment.” Metformin is an example of a widely used medication that some physicians have “repurposed” for off-label use. While it is a widely used medication to treat type 2 diabetes, Metformin has been used off label for cancer prevention, anti-aging, and has had some limited success in weight loss. Even aspirin is an example due to its proven record of reducing the risk of heart diseases. Clearly, healthcare providers are permitted to prescribe and authorize medications outside of the FDA-approved label to establish optimal patient care. 

Denial of payment or reimbursement for off-label use can interrupt or effectively deny access to necessary and appropriate treatment for vulnerable patient populations. In fact, several states have enacted laws permitting off-label use of FDA-approved medications. California, for example, mandates that off-label use of FDA-approved medications should not form the basis of coverage denials. PBMs’ abusive practices have brought detrimental impact upon pharmacies and their ability to operate and to service their patients. This is why Prime’s announcement is extremely concerning as the pharmacies will be penalized for filling and dispensing valid prescriptions, whether it be commercial or Medicare Part D claims, that are written or authorized by healthcare providers who have more in-depth knowledge of their patients’ medical conditions compared to PBMs. Additionally, the pharmacies are not required by any Federal or State law to maintain scientific evidence or any other materials to demonstrate the safety and efficacy of prescriptions. 

If your pharmacy is a member of Prime’s Pharmacy Network or has general questions about PBMs’ egregious practices against pharmacies, contact Frier Levitt today to speak to an attorney.