According to the 2015 Form 10-K filed by the drug manufacturer Insys Therapeutics, Inc., Humana began sending letters to its participating pharmacy providers in January 2016 “indicating that as a result of a CMS audit, Humana was initiating a deletion of certain [Prescription Drug Events] related to Subsys which will result in a reversal and recovery of identified claims paid to certain pharmacies.” Subsys and other TIRF drug products are subject to one of the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) programs, which is in place “to mitigate the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors by: (1) Prescribing and dispensing TIRF medicines only to appropriate patients, which includes use only in opioid-tolerant patients; (2) Preventing inappropriate conversion between fentanyl products; (3) Preventing accidental exposure to children and others for whom it was not prescribed; and (4) Educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose.” Because of the potentially serious risks posed by TIRF drug products, healthcare providers, pharmacies, patients, and wholesalers or distributors must enroll in the “TIRF REMS Access program” prior to the dispensing of TIRF drug products.
Due in no small part to the fact that TIRF drug products are Schedule II opioids subject to a REMS program, they typically require prior authorization by claims administrators such as Humana prior to being dispensed to patients. Essentially, the prior authorization process is controlled by the claims administrator, and a coverage determination is issued to the individual patient pursuant to a finding of “medical necessity” or other approved or supported uses for prescriptions written for any indicated use other than the “on-label”use. Subsys in particular is currently indicated only for “the management of breakthrough pain in adult cancer patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.” However, there can be no doubt that prescriptions written for “off-label” uses serve legitimate medical purposes, including for TIRF drug products. See, e.g., United States v. Caronia, 703 F.3d 49, 153 (2d Cir. 2012) (“Indeed, courts and the FDA have recognized the propriety and potential value of unapproved or off-label drug use.”) (collecting cases and FDA Guidance documents); see also U.S. Food and Drug Administration, Draft Guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices 3 (2009) (“[O]ff-label uses or treatment regimens may be important and may even constitute a medically[-]recognized standard of care.”). As a result, claims administrators often grant approval for the coverage and dispensing of TIRF drug products such as Subsys for supported off-label uses.
Unfortunately, claims administrators such as Humana may nevertheless choose to ignore their own granting of prior authorization to their members and seek recoupments for the entire value of previously-authorized prescription medications from their participating pharmacy providers. Frier Levitt is committed to defending pharmacy providers against these types of wrongful actions by Pharmacy Benefit Managers (PBMs) such as Humana, and has extensive experience in dealing with issues surrounding the dispensing—and subsequent auditing of—TIRF drug products such as Subsys. If you are a pharmacy who is being audited in this manner by a PBM or other entity, contact Frier Levitt today for a consultation.
