(A) Covered drugs
Drugs covered by the Ohio medicaid pharmacy program are limited to those that are manufactured or labeled by companies participating in the federal medicaid rebate program, dispensed by duly enrolled providers, and fall into one of the following categories:
(1) Legend and over-the-counter drugs listed in appendix A to rule 5101:3-9-12 of the Administrative Code.
(2) Legend and over-the-counter drugs not included in appendix A to rule 5101:3-9-12 of the Administrative Code but that have been prior authorized by the Ohio department of job and family services (ODJFS) or its designee, in accordance with paragraph (C) of this rule.
(3) Compounded prescriptions in accordance with paragraph (D) of this rule.
(B) Non-covered drugs
Drugs that fall into one of the following categories are non-covered by the Ohio medicaid pharmacy program:
(1) Drugs for the treatment of obesity.
(2) Drugs for the treatment of infertility.
(3) Drugs for the treatment of erectile dysfunction.
(4) DESI drugs or drugs that may have been determined to be identical, similar, or related.
(5) Drugs that are covered or may be covered by medicare part D, when prescribed for a consumer who is eligible for medicare, unless medicaid coverage for a dual eligible is indicated in appendix A to rule 5101:3-9-12 of the Administrative Code.
(6) Drugs being used for indications not approved by the food and drug administration unless there is compelling clinical evidence to support the experimental use.
(C) Prior authorization
Drugs not listed in appendix A to rule 5101:3-9-12 of the Administrative Code that are medically necessary for treatment require prior authorization; however, noncovered drugs listed in paragraphs (B)(1) to (B)(5) of this rule are not eligible for prior authorization.
(1) Prior authorization of pharmacy services will be administered in compliance with section 1927 of the Social Security Act, including a response by telephone or other telecommunication device within twenty-four hours of receipt of a request for prior authorization, and provisions for the dispensing of a seventy-two-hour supply of a covered outpatient prescription drug in an emergency situation.
(2) Drugs not listed in appendix A to rule 5101:3-9-12 of the Administrative Code may be covered with prior authorization if medical necessity is documented, the drug is not excluded per paragraphs (B)(1) to (B)(5) of this rule, and a drug listed in appendix A to rule 5101:3-9-12 of the Administrative Code cannot be used.
(3) Prior authorization of drugs not listed in appendix A to rule 5101:3-9-12 of the Administrative Code must be obtained from ODJFS or its designee before the drug may be dispensed. All requests must be submitted either verbally by telephone or in writing by facsimile device.
(a) Only the prescribing provider or a member of the prescribing provider's staff may request prior authorization except as described in paragraph (C)(3)(b) of this rule.
(b) A pharmacist may request prior authorization for an alternative dosage form of a drug to be administered through a tube for patients who are tube fed, if no comparable drugs listed in appendix A to rule 5101:3-9-12 of the Administrative Code can be administered through a tube. A pharmacist may also request prior authorization of a seventy-two-hour supply of a covered outpatient prescription drug in an emergency situation if the prescribing provider or prescribing provider's staff is not available to request prior authorization.
(4) Drugs in therapeutic classes that are covered or may be covered under medicare part D are not available for prior authorization for a consumer who is eligible for medicare. Prior authorization may be requested for drugs in drug classes or portions of drug classes that may be covered for a dual eligible as indicated in appendix A to rule 5101:3-9-12 of the Administrative Code and are subject to any stated limits.
(5) When a request for prior authorization is denied, the consumer will be informed in writing of the denial and the right to a state hearing.
(D) Compounded drugs
(1) Compounded drugs must be submitted to ODJFS or its designee using each national drug code (NDC) that is a part of the compound.
(2) Component drugs that are not in appendix A to rule 5101:3-9-12 of the Administrative Code will require prior authorization. If a prior authorization is not approved or if a component drug is not eligible for authorization (i.e., not manufactured or labeled by companies participating in the federal medicaid rebate program or excluded from direct reimbursement per paragraph (J) of this rule), the pharmacy provider may elect to receive payment only for those items in the compound that are directly reimbursed by ODJFS, in accordance with billing instructions issued by ODJFS or its designee.
(E) Dispensing limitations
(1) Days supply
(a) Acute medications are limited to a thirty-four-day supply.
(b) Chronic maintenance medications are limited to a one-hundred-two-day supply.
(2) Maximum quantity
Maximum prescription quantities are included in informational updates supplied to providers and represent the largest number of units per drug that may be dispensed at any one time for a single prescription or the largest number of units per drug per day (or other time period) of therapy.
(3) Claims submitted that exceed either the days supply limit or maximum quantity limit shall be denied. Denials may be overridden by ODJFS or its designee in cases where medical necessity has been determined.
(F) Refill prescriptions
Refills requested before seventy-five per cent of the days supply has been utilized will be denied, other than in cases where the dosage of a drug has been increased and has a new prescription number. Denials may be overridden by ODJFS or its designee for the following documented reasons:
(1) Previous supply was lost, stolen, or destroyed. ODJFS or its designee may limit the number of instances denials may be overridden in cases of suspected fraud or abuse, and may request additional documentation before an override is authorized.
(2) Pharmacist entered previous wrong day supply.
(3) Vacation or travel.
(4) Multiple supplies of the same medication are needed, for example in a workshop setting.
(5) Hospital or police kept the medication.
(6) Brand or generic was ineffective and the patient was switched to generic or brand.
(G) Unit dose
Drugs may be dispensed in unit dose packaging, but if the NDC number for such packaging is not listed in the Ohio medicaid drug payment system, the NDC number of the closest comparable bulk package that is listed in the payment system must be used for billing purposes.
(H) Vaccines, inoculations, and immunizations, other than seasonal and pandemic influenza vaccines, are covered as a pharmacy benefit only for residents of nursing facilities (NF) or intermediate care facilities for the mentally retarded (ICF-MR) as defined in section 5111.20 of the Revised Code; otherwise these services will be reimbursed as physician services in accordance with Chapter 5101:3-4 of the Administrative Code. Seasonal and pandemic influenza vaccines may be billed by the pharmacy for medicaid consumers who are not residents of NFs or ICFs-MR if the vaccine will be administered at the pharmacy.
(I) Selected pharmaceuticals, including injectable drugs, are not covered as an outpatient pharmacy benefit if they are administered in a provider setting.
(1) Long-acting injectable pharmaceuticals used for substance dependence or mental health conditions may be billed by the pharmacy under the following circumstances:
(a) The pharmaceutical is dispensed pursuant to a valid prescription; and
(b) The pharmaceutical is labeled with the patient name; and
(c) The pharmaceutical will be administered by a qualified healthcare professional in a provider setting; and
(d) The pharmacy and administering provider follow any special handling requirements in the package labeling; and
(e) The pharmacy releases the pharmaceutical only to the administering provider or member of the provider's staff, and has followed all regulations for a prescription pick-up station required by the Ohio state board of pharmacy. The pharmacy shall not dispense the pharmaceutical directly to the patient, caregiver, or patient's representative.
(2) Pharmaceuticals not described in paragraph (I)(1) of this rule administered in the physician's office must be purchased by the physician's office and billed as a physician claim.
(3) Pharmaceuticals administered in a provider setting, other than a NF or ICF-MR, and not described by paragraph (I)(1) of this rule, cannot be billed by the pharmacy.
(J) Selected over-the-counter drugs are not directly reimbursable when prescribed for consumers residing in a NF as defined in section 5111.20 of the Revised Code. Such drugs are the responsibility of the NF and reimbursed to the NF through the facility per diem. The over-the-counter drugs not separately reimbursable are those that are classified into the following drug classes:
(1) Analgesics, including urinary analgesics;
(2) Compounding vehicles and bulk chemicals;
(3) Cough and cold preparations and antihistamines, except preparations containing cetirizine, fexofenadine, or loratadine;
(4) Ear preparations;
(5) Gastrointestinal agents, except histamine-2 receptor antagonists, proton pump inhibitors, and loperamide;
(6) Hemorrhoidal preparations;
(7) Nasal preparations;
(8) Ophthalmic agents, except antihistamines;
(9) Saliva substitutes;
(11) Topical agents, except antifungal and acne preparations; or
(12) Vitamins and minerals, except prenatal vitamins and fluoride.
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 5111.02, 5111.98
Rule Amplifies: 5111.01, 5111.02, 5111.021, 5111.20, 5111.262, 5111.98
Prior Effective Dates: 4/7/77, 9/19/77, 12/21/77, 12/30/77, 7/8/78, 10/1/78, 5/9/86, 11/1/86, 10/1/87, 2/1/88, 1/13/89 (Emer), 4/13/89, 6/1/89, 7/1/94, 10/1/97, 2/3/00 (Emer), 5/1/00, 3/31/03 (Emer), 6/12/03, 10/16/03 (Emer), 1/1/04, 4/14/05, 10/15/05, 1/1/06, 7/1/06, 7/31/09 (Emer), 10/1/09 (Emer), 10/29/09, 12/29/09, 10/1/10