A new Connecticut law aids reimbursement to pharmacies for dispensing drugs prescribed off-label. “Off-label” prescriptions are medications that are being used in a manner not specified in the Food and Drug Administration’s (FDA) approved packaging label or insert. The practice—called “off-label” prescribing—is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies. Off-label prescribing can be beneficial, especially when patients have exhausted all other approved options, as may be the case with cancer or other disabling or life-threatening diseases.
However, many insurance companies will not pay for an expensive drug that is used in a way that is not listed in the approved drug label. Insurers do this on the grounds that its use is “experimental” or “investigational” when used for the off-label purpose. Many states, including Connecticut, have laws safeguarding coverage for off-label prescription drugs for patients with disabling, chronic or life-threatening conditions. In Connecticut, health insurers were prevented from denying coverage of off-label medications if the drug had been recognized by one of three standard medical references. However, two of the three compendia are no longer published. To rectify this issue, Connecticut broadened the references by adding “peer-reviewed medical literature” to justify “off-label” prescribing. This categorical addition gives pharmacies greater protection from potential recoupment by insurance plan administrators and Pharmacy Benefit Managers (PBMs) when dispensing drugs prescribed off-label.
Frier Levitt regularly counsels pharmacies regarding the legal and contractual considerations of claims rejected and recouped by PBMs. The attorneys at Frier Levitt can assists your pharmacy in ensuring that PBM’s are not unjustly denying coverage and are adhering to their contractual obligations. Contact us to find out how we can assist your pharmacy.
