§ 369-BB — Drug utilization review board

§ 369-bb. Drug utilization review board. 1. A twenty-three-member\ndrug utilization review board is hereby created in the department. The\nboard is responsible for the establishment and implementation of medical\nstandards and criteria for the retrospective and prospective DUR\nprogram.\n 2. The members of the DUR board shall be appointed by the commissioner\nand shall serve a three-year term. Members may be reappointed upon the\ncompletion of other terms. The membership shall be comprised of the\nfollowing:\n (a) Six persons licensed and actively engaged in the practice of\nmedicine in the state, with expertise in the areas of mental health,\nHIV/AIDS, geriatrics, pediatrics or internal medicine and who may be\nselected based on input from professional associations and/or advocacy\ngroups in New York state.\n (b) Six persons licensed and actively practicing in pharmacy in the\nstate who may be selected based on input from professional associations\nand/or advocacy groups in New York state.\n (c) Two persons with expertise in drug utilization review who are\nhealth care professionals licensed under Title VIII of the education law\nat least one of whom is a pharmacologist.\n (d) Three persons that are consumers or consumer representatives of\norganizations with a regional or statewide constituency and who have\nbeen involved in activities related to health care consumer advocacy,\nincluding issues affecting Medicaid or EPIC recipients.\n (e) One person licensed and actively practicing as a nurse\npractitioner or midwife.\n (f) Two persons who are health care economists.\n (g) One person who is an actuary.\n (h) One person representing the department of financial services.\n (i) The commissioner shall designate a person from the department to\nserve as chairperson of the board.\n 3. The appointed members to the board, or its agents shall have no\nsanctions against them by medicare or medicaid.\n 4. The appointments to this board shall be made so that the length of\nthe terms are staggered. In making the appointments, the commissioner\nshall consider geographic balance in the representation on the board.\n 5. (a) The functions, powers and duties of the former pharmacy and\ntherapeutics committee as established in article two-A of the public\nhealth law shall now be considered a function of the drug utilization\nreview board, including but not limited to:\n (i) conducting an executive session for the purpose of receiving and\nevaluating drug pricing information related to supplemental rebates, or\nreceiving and evaluating trade secrets, or other information which, if\ndisclosed, would cause substantial injury to the competitive position of\nthe manufacturer; and\n (ii) evaluating and providing recommendations to the commissioner of\nhealth on other issues relating to pharmacy services under Medicaid or\nEPIC, including, but not limited to: therapeutic comparisons; enhanced\nuse of generic drug products; enhanced targeting of physician\nprescribing patterns; and\n (iii) collaborating with managed care organizations to address drug\nutilization concerns and to implement consistent management strategies\nacross the fee-for-service and managed care pharmacy benefits.\n (b) Any business or other matter undertaken or commenced by the\npharmacy and therapeutics committee pertaining to or connected with the\nfunctions, powers, obligations and duties are hereby transferred and\nassigned to the drug utilization review board and pending on the\neffective date of this subdivision, may be conducted and completed by\nthe drug utilization review board in the same manner and under the same\nterms and conditions and with the same effect as if conducted and\ncompleted by the pharmacy and therapeutics committee. All books, papers,\nand property of the pharmacy and therapeutics committee shall continue\nto be maintained by the drug utilization review board.\n (c) All rules, regulations, acts, orders, determinations, and\ndecisions of the pharmacy and therapeutics committee pertaining to the\nfunctions and powers herein transferred and assigned, in force at the\ntime of such transfer and assumption, shall continue in full force and\neffect as rules, regulations, acts, orders, determinations and decisions\nof the drug utilization review board until duly modified or abrogated by\nthe commissioner of health.\n 6. Members of the DUR utilization review board and all its employees\nand agents shall be deemed to be an "employee" for purposes of section\nseventeen of the public officers law.\n 7. The department shall provide administrative support to the DUR\nboard.\n 8. The duties of the DUR board are as follows:\n (a) The development and application of the predetermined criteria and\nstandards to be used in retrospective and prospective DUR that ensure\nthat such criteria and standards are based on the compendia and that\nthey are developed with professional input in a consensus fashion with\nprovisions for timely revisions and assessments as necessary. Further,\nthat the DUR standards shall reflect the appropriate practices of\nphysicians in order to monitor:\n (i) Therapeutic appropriateness;\n (ii) Overutilization or underutilization;\n (iii) Therapeutic duplication;\n (iv) Drug-disease contraindications;\n (v) Drug-drug interactions;\n (vi) Incorrect drug dosage or duration of drug treatment; and\n (vii) Clinical abuse/misuse.\n (b) The development, selection, application, and assessment of\ninterventions or remedial strategies for physicians, pharmacists, and\nrecipients that are educational and not punitive in nature to improve\nthe quality of care including:\n (i) Information disseminated to physicians and pharmacists to ensure\nthat physicians and pharmacists are aware of the board's duties and\npowers;\n (ii) Written, oral, or electronic reminders of patient-specific or\ndrug-specific information that are designed to ensure recipient,\nphysician, and pharmacist confidentiality, and suggested changes in the\nprescribing or dispensing practices designed to improve the quality of\ncare;\n (iii) Use of face-to-face discussions between experts in drug therapy\nand the prescriber or pharmacist who has been targeted for educational\nintervention;\n (iv) Intensified reviews or monitoring of selected prescribers or\npharmacists;\n (v) The creation of an educational program using data provided through\nDUR to provide for active and ongoing educational outreach programs to\nimprove prescribing and dispensing practices as provided in this\nsubdivision. (This may be done directly or through contract with other\nentities);\n (vi) The timely evaluation of interventions to determine if the\ninterventions have improved the quality of care; and\n (vii) The review of case profiles prior to the conducting of an\nintervention.\n (c) The publication of an annual report which shall be subject to the\ndepartment's comment prior to its issuance to the federal department of\nhealth and human services by December first of each year. The annual\nreport also shall be submitted to the governor and the legislature\nbefore December first of each year. The report shall include the\nfollowing information:\n (i) A description of the activities of the board, including the nature\nand scope of the prospective and retrospective drug use review programs;\n (ii) A summary of the interventions used;\n (iii) An assessment of the impact of these educational interventions\nin quality of care;\n (iv) An estimate of the cost savings generated as a result of such\nprogram; and\n (v) Recommendations for program improvement.\n (d) The development of a working agreement for the DUR board with\nrelated boards or agencies, including, but not limited to: the board of\npharmacy, the board of medicine, the SURS staff, and staff of the\ndepartment of health and the office of mental health, in order to\nclarify the areas of responsibility for each where such areas may\noverlap.\n (e) The establishment of a process where physicians or pharmacists\nwill have the opportunity to submit responses to the DUR educational\nletters.\n (f) The publication and dissemination of educational information to\nphysicians and pharmacists on the DUR board and the DUR program to\ninclude information on:\n (i) Identifying and reducing the frequency of patterns of fraud,\nabuse, gross overuse, or inappropriate or medically unnecessary care\namong physicians, pharmacists, and recipients;\n (ii) Potential or actual severe/adverse reactions to drugs;\n (iii) Therapeutic appropriateness;\n (iv) Overutilization or underutilization;\n (v) Appropriate use of generics;\n (vi) Therapeutic duplication;\n (vii) Drug-disease contraindications;\n (viii) Drug-drug interactions;\n (ix) Incorrect drug dosage/duration of drug treatments;\n (x) Drug allergy interactions; and\n (xi) Clinical abuse/misuse.\n (g) The evaluation of specific drugs submitted to the board for review\npursuant to section two hundred eighty of the public health law, and the\nformulation of recommended target supplemental rebates, in accordance\nwith the standards established in such section.\n (h) The adoption and implementation of procedures designed to ensure\nthe confidentiality of any information collected, stored, retrieved,\nassessed or analyzed by the DUR board, staff to the board, or\ncontractors to the DUR program, that identifies individual physicians,\npharmacists, or recipients. The board may have access to identifying\ninformation for purposes of carrying out intervention activities, but\nsuch identifying information may not be released to anyone other than a\nmember of the DUR board or the department and its agents.\n (i) The improper release of identifying information in violation of\nthis article may subject that person to criminal or civil penalties.\n (j) The board may release cumulative non-identifying information for\npurposes of legitimate research.\n 9. The relationship of the DUR board to the department is as follows:\n (a) The department shall monitor the DUR board's compliance to federal\nand state statute and regulation.\n (b) The DUR board shall serve at the discretion of the commissioner.\n (c) The department shall have authority on all fiscal matters relating\nto the DUR program.\n (d) The department shall have authority on all administrative matters\nrelating to the administration of the medical assistance program within\nthe DUR program.\n (e) The DUR board shall have responsibility for all medical matters\nrelating to the DUR program.\n (f) The DUR board may utilize medical consultants and review\ncommittees as necessary, subject to department approval.\n