§ 58-3-221. Access to nonformulary and restricted access prescription drugs.
§ 58‑3‑221. Access to nonformulary and restricted access prescription drugs.
(a) If an insurermaintains one or more closed formularies for or restricts access to coveredprescription drugs or devices, then the insurer shall do all of the following:
(1) Develop theformulary or formularies and any restrictions on access to covered prescriptiondrugs or devices in consultation with and with the approval of a pharmacy andtherapeutics committee, which shall include participating physicians who arelicensed to practice medicine in this State.
(2) Make available toparticipating providers, pharmacists, and enrollees the complete drugs ordevices formulary or formularies maintained by the insurer including a list ofthe devices and prescription drugs on the formulary by major therapeuticcategory that specifies whether a particular drug or device is preferred overother drugs or devices.
(3) Establish andmaintain an expeditious process or procedure that allows an enrollee or theenrollee's physician acting on behalf of the enrollee to obtain, withoutpenalty or additional cost‑sharing beyond that provided for in the healthbenefit plan, coverage for a specific nonformulary drug or device determined tobe medically necessary and appropriate by the enrollee's participatingphysician without prior approval from the insurer, after the enrollee'sparticipating physician notifies the insurer that:
a. Either (i) theformulary alternatives have been ineffective in the treatment of the enrollee'sdisease or condition, or (ii) the formulary alternatives cause or arereasonably expected by the physician to cause a harmful or adverse clinicalreaction in the enrollee; and
b. Either (i) the drugis prescribed in accordance with any applicable clinical protocol of theinsurer for the prescribing of the drug, or (ii) the drug has been approved asan exception to the clinical protocol pursuant to the insurer's exceptionprocedure.
(4) Provide coverage fora restricted access drug or device to an enrollee without requiring prior approvalor use of a nonrestricted formulary drug if an enrollee's physician certifiesin writing that the enrollee has previously used an alternative nonrestrictedaccess drug or device and the alternative drug or device has been detrimentalto the enrollee's health or has been ineffective in treating the same conditionand, in the opinion of the prescribing physician, is likely to be detrimentalto the enrollee's health or ineffective in treating the condition again.
(b) An insurer may notvoid a contract or refuse to renew a contract between the insurer and aprescribing provider because the prescribing provider has prescribed amedically necessary and appropriate nonformulary or restricted access drug ordevice as provided in this section.
(c) As used in thissection:
(1) "Closedformulary" means a list of prescription drugs and devices reimbursed bythe insurer that excludes coverage for drugs and devices not listed.
(1a) "Health benefitplan" has definition provided in G.S. 58‑3‑167.
(2) "Insurer"has the meaning provided in G.S. 58‑3‑167.
(3) "Restrictedaccess drug or device" means those covered prescription drugs or devicesfor which reimbursement by the insurer is conditioned on the insurer's priorapproval to prescribe the drug or device or on the provider prescribing one ormore alternative drugs or devices before prescribing the drug or device inquestion.
(d) Nothing in thissection requires an insurer to pay for drugs or devices or classes of drugs ordevices related to a benefit that is specifically excluded from coverage by theinsurer. (1999‑178,s. 1; 1999‑294, s. 14(a), (b); 2001‑446, s. 1.5.)