§ 274 — Clinical drug review program

§ 274. Clinical drug review program. 1. In addition to the preferred\ndrug program established by this article, the commissioner may establish\na clinical drug review program. The commissioner may, from time to time,\nrequire prior authorization under such program for prescription drugs or\npatterns of utilization under state public health plans. When a\nprescriber prescribes a drug which requires prior authorization under\nthis section, state public health plan reimbursement shall be denied\nunless such prior authorization is obtained.\n 2. The clinical drug review program shall make available a twenty-four\nhour per day, seven days per week response system.\n 3. In establishing a prior authorization requirement for a drug under\nthe clinical drug review program, the commissioner shall consider the\nfollowing:\n (a) whether the drug requires monitoring of prescribing protocols to\nprotect both the long-term efficacy of the drug and the public health;\n (b) the potential for, or a history of, overuse, abuse, drug diversion\nor illegal utilization; and\n (c) the potential for, or a history of, utilization inconsistent with\napproved indications. Where the commissioner finds that a drug meets at\nleast one of these criteria, in determining whether to make the drug\nsubject to prior authorization under the clinical drug review program,\nthe commissioner shall consider whether similarly effective alternatives\nare available for the same disease state and the effect of that\navailability or lack of availability.\n 4. The commissioner shall obtain an evaluation of the factors set\nforth in subdivision three of this section and a recommendation as to\nthe establishment of a prior authorization requirement for a drug under\nthe clinical drug review program from the drug utilization review board.\nFor this purpose, the commissioner and the board, as applicable, shall\ncomply with the following meeting and notice processes established by\nthis article:\n (a) the open meetings law and freedom of information law provisions of\nsubdivision six of section two hundred seventy-one of this article; and\n (b) the public notice and interested party provisions of subdivisions\nseven, eight and nine of section two hundred seventy-two of this\narticle.\n 5. The board shall recommend a procedure and criteria for the approval\nof drugs subject to prior authorization under the clinical drug review\nprogram. Such criteria shall include the specific approved clinical\nindications for use of the drug.\n 6. The commissioner shall identify a drug for which prior\nauthorization is required, as well as the procedures and criteria for\napproval of use of the drug, under the clinical drug review program\nafter considering the recommendations from the board and any comments\nreceived from prescribers, dispensers, consumers and manufacturers of\nthe drug. In no event shall the prior authorization criteria for\napproval pursuant to this subdivision result in denial of the prior\nauthorization request based on the relative cost of the drug subject to\nprior authorization.\n 7. In the event that the patient does not meet the criteria for\napproval established by the commissioner in subdivision six of this\nsection, the clinical drug review program shall provide a reasonable\nopportunity for a prescriber to reasonably present his or her\njustification for prior authorization. If, after consultation with the\nprogram, the prescriber, in his or her reasonable professional judgment,\ndetermines that the use of the prescription drug is warranted, the\nprescriber's determination shall be final and prior authorization shall\nbe granted under this section; provided, however, that prior\nauthorization may be denied in cases where the department has\nsubstantial evidence that the prescriber or patient is engaged in fraud\nor abuse relating to the drug.\n 8. In the event that a patient presents a prescription to a pharmacist\nfor a prescription drug that requires prior authorization under this\nsection and for which prior authorization has not been obtained, the\npharmacist shall, within a prompt period based on professional judgment,\nnotify the prescriber. The prescriber shall, within a prompt period\nbased on professional judgment, either seek prior authorization or shall\ncontact the pharmacist and amend or cancel the prescription. The\npharmacist shall, within a prompt period based on professional judgment,\nnotify the patient when prior authorization has been obtained or denied\nor when the prescription has been amended or cancelled.\n 9. In the instance where a prior authorization determination is not\ncompleted within twenty-four hours of the original request solely as the\nresult of a failure of the program (whether by action or inaction),\nprior authorization shall be immediately and automatically granted\nwithout further action by the prescriber and the prescriber shall be\nnotified of this determination. In the instance where a prior\nauthorization determination is not completed within twenty-four hours of\nthe original request for any other reason, a seventy-two hour supply of\nthe medication will be approved by the program and the prescriber shall\nbe notified of the determination.\n 10. When, in the judgment of the prescriber or the pharmacist, an\nemergency condition exists, and the prescriber or pharmacist notifies\nthe program to confirm that such an emergency condition exists, a\nseventy-two hour emergency supply of the drug prescribed shall be\nimmediately authorized by the program.\n 11. The department or the panel shall monitor the prior authorization\nprocess for prescribing patterns which are suspected of endangering the\nhealth and safety of the patient or which demonstrate a likelihood of\nfraud or abuse. The department or the panel shall take any and all\nactions otherwise permitted by law to investigate such prescribing\npatterns, to take remedial action and to enforce applicable federal and\nstate laws.\n 12. The commissioner may implement all or a portion of the clinical\ndrug review program through contracts with administrators with expertise\nin management of pharmacy services, subject to applicable laws.\n 13. No prior authorization under the clinical drug review program\nshall be required for any prescription under EPIC until the commissioner\nhas made prior authorization applicable to EPIC under section two\nhundred seventy-five of this article.\n 14. For the period of eighteen months, commencing with the date of\nenactment of this article, the commissioner is authorized to continue\nprior authorization requirements for prescription drugs subject to prior\nauthorization as of one day prior to the enactment of this article and\nwhich are not described in subdivision fourteen of section two hundred\nseventy-two of this article. At the conclusion of the eighteen month\nperiod, any such drug shall be subject to the clinical drug review\nprogram requirements of this section; provided, however, that the\ncommissioner is authorized to immediately subject any such drug to prior\nauthorization without regard to the provisions of subdivisions three\nthrough six of this section.\n