Violations of Prescriptions and Licensing Requirements

What are violations of prescriptions and licensing requirements?

Medicare Part D and Medicaid are not supposed to pay for prescription medications unless they are dispensed by pharmacists or other authorized practitioners who are licensed under State law to dispense medications, and the medications have been dispensed pursuant to prescriptions that are valid under State law.

With limited exceptions, State Boards of Pharmacy universally require pharmacies to have received prescriptions with all required elements — such as name and signature of a licensed prescriber, drug quantity, and authorization of refills, if any — before they may dispense medication. The law is particularly stringent when it comes to controlled substances (such as oxycodone) that pose a risk of dependence, abuse and even addiction. For example, the Controlled Substances Act, 21 U.S.C. § 801 et seq., requires written prescriptions for all Schedule II drugs (the drugs posing the greatest risk) unless there is an emergency. 21 U.S.C. § 829(a). A pharmacy cannot refill a Schedule II drug at all, and cannot fill or refill a Schedule III-IV drug more than six months after the date of the prescription. 21 U.S.C. § 829(a) and (b).

When pharmacies bill Medicare Part D or Medicaid, they agree to comply with these federal and state rules, as well as other rules regulating the practice of pharmacy. These government health programs cover medications only if the drugs are “[d]ispensed by licensed pharmacists and licensed authorized practitioners in accordance with the State Medical Practice Act” and “on a written prescription that is recorded and maintained in the pharmacist’s or practitioner’s records.” 42 U.S.C. § 1396r-8(k)(2); 42 C.F.R. 440.120(a); 42 U.S.C. § 1395w-102(e) (defining covered Part D drugs by reference to the Medicaid coverage provisions in 42 U.S.C. § 1396r-8(k)(2)). If pharmacies violate these rules and bill Medicare Part D or Medicaid nonetheless, they face potential liability under the False Claims Act. If the violation involves a significant threat of patient harm or billing for unreasonable or unnecessary services, the risk of enforcement action heightens.