(A) Patient profiles, prospective drug utilization review (DUR), and patient counseling
(1) Patient profiles, prospective DUR and patient counseling must be performed for medicaid patients by medicaid pharmacy providers in accordance with Chapter 4729-5 of the Administrative Code.
(2) Documentation and records required by Chapter 4729-5 of the Administrative Code must be maintained in accordance with rule 5160-1- 17.2 of the Administrative Code.
(3) In addition to the prospective DUR required in paragraphs (A)(1) and (A)(2) of this rule, the Ohio department of medicaid (ODM) or its designee will also perform prospective DUR at the time of claim adjudication and may deny claims that exceed limitations described in rule 5160-9-03 of the Administrative Code or that, on their own or in combination with other claims previously adjudicated, have been determined to have a high risk for fraud, waste, abuse, or clinically significant adverse medical results. Denials may be overridden by ODM or its designee through the prior authorization process in cases where medical necessity has been determined.
(4) Prospective DUR will be performed for the purpose of identifying prescriptions that may not be therapeutically appropriate, as described in paragraphs (B)(1)(b) to (B)(1)(j) of this rule.
(B) Retrospective DUR
(1) Retrospective DUR shall be performed by ODM or its designee on an ongoing periodic basis to monitor the following:
(a) Therapeutic appropriateness;
(d) Appropriate use of generic products;
(e) Therapeutic duplication;
(f) Drug-disease state contraindications;
(g) Drug-drug interactions;
(h) Incorrect drug dosage;
(i) Incorrect duration of drug treatment; and
(j) Clinical abuse/misuse.
(2) The "Drug Utilization Review board," defined in paragraph (C) of this rule, shall, in compliance with 42 U.S.C. 1396r-8 ( April 1, 2017), review and recommend criteria used for retrospective DUR using predetermined standards consistent with, but not limited to, any of the following:
(a) American hospital formulary service drug information;
(b) United States pharmacopeia drug information;
(c) American medical association drug evaluations;
(d) Drugdex information system; and
(e) Peer-reviewed medical literature (that is, scientific, medical, and pharmaceutical publications in which original manuscripts are rejected or published after having been critically reviewed by unbiased independent experts).
(3) Remedial strategies shall be recommended by the DUR board and may be approved by ODM for use when clinical concerns are identified based on the monitoring of items listed in paragraph (B)(1) of this rule.
(C) DUR board
(a) The DUR board shall include health care professionals appointed by the medicaid director who have recognized knowledge and expertise in one or more of the following:
(i) Clinically appropriate prescribing of covered outpatient drugs;
(ii) Clinically appropriate dispensing and monitoring of covered outpatient drugs;
(iii) Drug use review, evaluation, and intervention; or
(iv) Medical quality assurance.
(b) The DUR board shall be composed of four licensed and actively practicing physicians, at least one of which is a doctor of osteopathic medicine, four licensed and actively practicing pharmacists, and one nonvoting ODM staff person. Candidates may be submitted for consideration by the professional health care associations.
(c) The chairperson of the DUR board shall be elected by the membership for a one-year term and must be one of the licensed professionals as specified in paragraph (C)(1)(b) of this rule.
(a) Two of the original physician appointments and two of the original pharmacist appointments shall be for two years, with the remaining appointments being for one year. Subsequent appointments shall be for two years. The ODM staff person shall be an ongoing member of the board.
(b) Vacancies shall be filled for the unexpired terms in the same manner as the original appointments.
(a) The DUR board shall review and recommend criteria used in DUR.
(b) The DUR board shall recommend multiple levels of interventions for physicians and pharmacists targeted toward therapy problems or individuals identified in the course of retrospective drug use reviews. Intervention programs shall include, in appropriate instances, at least:
(i) Written, oral, or electronic reminders containing patient specified and/or drug specific information and suggested changes in prescribing or dispensing practices, communicated in a way to ensure the privacy of patient related information;
(ii) Use of face-to-face or telephone discussions between health care professionals who are experts in rational drug therapy and selected prescribers and pharmacists who have been targeted for educational intervention, including discussion of optimal prescribing, dispensing, or pharmacy care practices; and
(iii) Intensified review or monitoring of selected prescribers, dispensers, or patients. This may include, but not be limited to, referral to the appropriate licensure board or ODM surveillance and utilization review area.
(c) Criteria and interventions utilized by ODM shall be reported back to the DUR board. The DUR board shall reevaluate interventions after an appropriate period of time to determine if the intervention improved the quality of drug therapy, evaluate the success of the interventions, and recommend modifications as necessary.
(d) The DUR board shall develop an informational package on the nature of the drug utilization review program.
(e) The DUR board shall provide for active and ongoing educational outreach programs to educate practitioners on common therapy problems and quality improvement initiatives.
(f) The DUR board shall prepare an annual report for ODM that includes:
(i) A description of the board's activities, including the nature and scope of the prospective and retrospective drug use review programs;
(ii) A summary of the interventions used;
(iii) An assessment of the impact of these educational interventions on quality of care; and
(iv) An estimate of the cost savings generated as a result of such program.
(4) Meetings and compensation
(a) The DUR board shall meet quarterly, unless ODM determines additional meetings are necessary, to perform the duties described in paragraph (C)(3) of this rule.
(b) The portion of the DUR board meeting dealing with the consideration of criteria and general interventions shall be open to any interested party.
(c) The ODM shall reimburse each board member, other than the ODM staff person, one hundred fifty dollars per meeting.
Five Year Review (FYR) Dates: 01/13/2017 and 04/01/2022
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03, 5164.02 , 5164.759
Prior Effective Dates: 1/1/93, 7/1/93, 10/1/97, 2/3/00 (Emer), 5/1/00, 8/30/01, 4/14/05, 9/17/07, 10/5/13