Chapter 5160-9 Pharmacy Services

5160-9-01 Eligible providers of pharmacy services.

Three types of providers are eligible for reimbursement for pharmacy services: "pharmacy providers," "hospitals" with a "pharmacy" category of service, and "clinics" with a "pharmacy" category of service.

(A) A "pharmacy provider" designation and provider number can be obtained by a "terminal distributor of dangerous drugs," as defined in section 4729.01 of the Revised Code, who also:

(1) Has a valid drug enforcement agency (DEA) number; and

(2) Has a licensed registered pharmacist in full and actual charge of a pharmacy; and

(3) Complies with eligible provider rules 5101:3-1-17 to

5101:3-1- 17.4 of the Administrative Code and signs a provider agreement with the Ohio department of job and family services.

(B) A "hospital" provider acting as a pharmacy in accordance with paragraphs (A)(1) to (A)(3) of this rule can obtain a "pharmacy" category of service and bill for self-administered take-home drugs.

(C) "Clinic" providers that have a valid medicaid provider agreement and have met the criteria under the Revised Code for dispensing pharmaceuticals but are not eligible to become a "pharmacy provider" as defined in paragraph (A) of this rule, are eligible to apply for a "pharmacy" category of service and bill for self-administered take-home drugs.

Effective: 08/02/2011
R.C. 119.032 review dates: 09/20/2010 and 08/01/2016
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
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, 04/14/05

5160-9-02 Pharmacy services: medical supplies and durable medical equipment.

(A) Eligible pharmacies in the Ohio medicaid program may bill for medical supplies and durable medical equipment in accordance with Chapter 5101:3-10 of the Administrative Code, with the following stipulations:

(1) The provider must apply to the Ohio department of medicaid (ODM) to be eligible to dispense medical supplies/durable medical equipment.

(2) All products require a prescription written by a practitioner authorized to prescribe. The prescription must be obtained by and kept on file at the pharmacy.

(3) The provider must use the same medicaid provider number as when billing for pharmaceuticals.

(4) The provider must be licensed, registered, or exempt from licensure or registration under Chapter 4761. of the Revised Code to bill for home medical equipment that is subject to regulation under Chapter 4752. of the Revised Code.

(B) Invoices submitted for medical supplies/durable medical equipment must be billed on the appropriate invoice designated by ODM for those services.

(C) Medical supplies, durable medical equipment, prosthetic, and orthotic devices may be billed by pharmacy providers in accordance with Chapter 5101:3-10 of the Administrative Code.

(D) Only eligible providers of pharmacy services as described in rule 5101:3-9-01 of the Administrative Code are eligible to bill for the medical supplies listed in the appendix to this rule, except as specified in paragraph (G) of this rule. Eligible providers of pharmacy services may bill for these items without applying to ODM to be eligible to dispense medical supplies/durable medical equipment as described in Chapter 5101:3-10 of the Administrative Code.

(E) The quantity billed should be equal to the number of items dispensed (e.g., the quantity of test strips billed should be the number of individual test strips, not the number of boxes). The table in the appendix to this rule includes five columns to indicate supply item coverage and reimbursement.

(1) Item description. This column describes the supply item.

(2) Medicaid coverage status. This column has one of two possible indicators for each item. "Y" indicates the item is covered by medicaid for all consumers and may be billed directly to ODM by the provider. "H" indicates that the item may be billed directly to ODM only for consumers who reside in their personal residence. For consumers residing in a nursing facility (NF) or intermediate care facility for the mentally retarded (ICF-MR) as defined in section 5111.20 of the Revised Code, the supply is the responsibility of the NF or ICF-MR and reimbursed to the NF or ICF-MR through the facility per diem payment.

(3) Covered for dual eligible. This column indicates whether the supply is covered under the medicaid program for a consumer who is a dual eligible as defined in rule 5101:3-1-05 of the Administrative Code. "Y" indicates the supply is covered for a dual eligible. "N" indicates the supply is not covered for a dual eligible.

(4) Maximum units. This column indicates the largest number of units of the supply that may be dispensed within the time period indicated. Claims submitted that exceed the maximum units shall be denied. Denials may be overridden by ODM or its designee in cases where medical necessity has been determined through prior authorization obtained by the prescriber from the ODM point-of-sale vendor.

(5) Reimbursement. This column indicates the medicaid maximum reimbursement per item as defined in rule 5101:3-1-60 of the Administrative Code. Supplies with "*" in this column indicate that reimbursement will be calculated in accordance with paragraph (B)(2) of rule 5101:3-9-05 of the Administrative Code.

(F) The supplies listed in the appendix to this rule should be billed through the pharmacy point of sale claims system using the national drug code (NDC) on the container from which the product was dispensed.

(1) Reimbursement shall be the lesser of the submitted charge or the calculated allowable. The calculated allowable is the medicaid maximum reimbursement as described in paragraph (E)(5) of this rule.

(2) Prior authorization may be requested by the prescriber or a member of the prescribing provider's staff if there is medical necessity for quantities above those stated in the appendix to this rule.

(G) Exceptions to pharmacy billing requirement.

(1) Contraceptive supplies listed in the appendix to this rule may be billed by both pharmacy providers and providers eligible to bill in accordance with rule 5101:3-10-01 of the Administrative Code. Pharmacy providers shall bill these supplies in accordance with paragraph (F) of this rule.

(2) Supplies billed to medicare as the primary payer and crossed over to medicaid using the medicare crossover process described in paragraph (B) of rule 5101:3-1-05 of the Administrative Code may be billed by any provider eligible for the medicare crossover process.

(H) Preferred diabetic blood testing supplies

(1) Products from the following manufacturers have been selected as preferred diabetic blood testing supplies:

(a) "Abbott Diabetes Care"

(b) "Nipro Diagnostics"

(2) Products from manufacturers or distributers that have not been selected as preferred require prior authorization.

(a) Only the prescribing provider or a member of the prescribing provider's staff may request prior authorization.

(b) The prescriber must document medical necessity for the non-preferred product and why a preferred product cannot be used.

(c) 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.

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Effective: 07/01/2013
R.C. 119.032 review dates: 04/16/2013 and 07/01/2018
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021 , section 309.30.30 of Am. Sub. H.B. 153, 129th G. A.
Prior Effective Dates: 4/7/77, 12/21/77, 5/9/86, 10/1/97, 8/30/01, 7/1/06, 2/1/10, 10/1/11

5160-9-03 Covered drugs and associated limitations.

(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;

(10) Sedatives;

(11) Topical agents, except antifungal and acne preparations; or

(12) Vitamins and minerals, except prenatal vitamins and fluoride.

Effective: 10/01/2012
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

5160-9-04 Pharmacy services: drug utilization review.

(A) Patient profiles, prospective drug utilization review, and patient counseling

(1) Patient profiles, prospective drug utilization review, 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 5101:3-1-17.2 of the Administrative Code.

(3) In addition to the prospective drug utilization review required in paragraphs

(A)

(1) and (A)(2) of this rule, the ) Ohio department of medicaid (ODM ) or its designee will also perform prospective drug utilization review at the time of claim adjudication and may deny claims that exceed limitations described in rule 5101:3-9-03 of the Administrative Code. Denials may be overridden by ODM or its designee in cases where medical necessity has been determined.

(4) Prospective drug utilization review 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 drug utilization review

(1) Retrospective drug utilization review shall be performed by ODM or its designee on an ongoing periodic basis to monitor the following:

(a) Therapeutic appropriateness;

(b) Overutilization;

(c) Underutilization;

(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 (DUR) board," defined in paragraph (C) of this rule, shall, in compliance with 42 U.S.C. 1396r-8 (June 13, 2013), review and recommend criteria used for retrospective drug utilization 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

(1) Membership

(a) The DUR board shall include health care professionals appointed by the medicaid director ODM 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.

(2) Terms

(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.

(3) Duties

(a) The DUR board shall review and recommend criteria used in drug utilization review.

(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 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.

Effective: 10/05/2013
R.C. 119.032 review dates: 07/19/2013 and 10/01/2018
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.08
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

5160-9-05 Reimbursement.

(A) Reimbursement shall be the lesser of the submitted charge or the calculated allowable in accordance with paragraphs (B) to (C) of this rule. For medications that are subject to a co-payment, the amount reimbursed by the Ohio department of job and family services (ODJFS) will be decreased by the amount equal to the co-payment that is to be billed to the consumer in accordance with rule 5101:3-9-09 of the Administrative Code.

(B) Determination of allowable pharmaceutical product cost

(1) Maximum allowable cost (MAC) pharmaceuticals

(a) Maximum allowable costs have been determined by the federal department of health and human services for selected drugs. ODJFS shall not make reimbursement for these products, in the aggregate, at a rate higher than the federal upper limit (FUL) prices.

Drugs that have been identified in appendix A to rule 5101:3-9-12 of the Administrative Code as brand medically necessary(BMN) may only be dispensed without prior authorization when the prescriber has indicated "brand medically necessary" or "BMN" on the prescription.

(b) ODJFS may establish a MAC for additional selected drugs where either bio-equivalency of the drugs has been established or bio-inequivalency of the drugs has not been established. Reimbursement for state MAC drugs shall be based on the sixty-fifth percentile of the estimated acquisition cost of all readily available generically equivalent drugs.

(2) Estimated acquisition cost (EAC) pharmaceuticals

(a) All products, other than those designated as MAC drugs, will be considered EAC drugs. Reimbursement will be based on the estimate of wholesale acquisition cost (WAC) determined by periodic review of pricing information from Ohio drug wholesalers, pharmaceutical manufacturers and a pharmacy pricing update service. Maximum reimbursement for these drugs will be WAC plus seven per cent for claims with dates of service on or after October 1, 2005.

(b) In the event that WAC cannot be determined, ODJFS will define "EAC" as average wholesale price (AWP) minus 14.4 per cent for claims with dates of service on or after October 1, 2005.

(3) No reimbursement of product cost will be paid for pandemic influenza vaccine that is provided by the Ohio department of health or other government entity at no charge to the provider.

(C) Dispensing fees

(1) Eligibility for a dispensing or administration fee

(a) Only pharmacy and hospital providers as defined in rule 5101:3-9-01 of the Administrative Code are eligible to receive a dispensing or administration fee.

(b) Providers eligible to provide pharmacy services in accordance with paragraph (C) of rule 5101:3-9-01 of the Administrative Code are eligible to receive reimbursement for only the product cost. No dispensing or administration fee shall be paid.

(c) Dispensing fees for prescriptions, other than compounded drugs, dispensed to patients residing in nursing facilities (NF) or intermediate care facilities for the mentally retarded (ICF-MR) as defined in section 5111.20 of the Revised Code shall be limited to one dispensing fee per patient per generic code number (GCN) per rolling twenty-five days. In the event that multiple prescriptions within a single GCN are dispensed within a twenty-five day timespan, only the product cost will be reimbursed. Exceptions to the single dispensing fee are:

(i) Cases where the physician has prescribed a second round of medication within the twenty-five day period.

(ii) Cases where the physician has changed the dosage.

(iii) Cases where the medication did not last for the intended days supply.

(iv) Cases where the drug has been compromised by accident (e.g., contaminated or destroyed).

(v) Controlled substances (limited to two dispensing fees per twenty-five days).

When medications are delivered to the patient from an emergency or similar supply held in reserve by the NF or ICF-MR, the pharmacy provider must dispense and bill for the total prescription as one dispensation with one fee and arrange for the orderly replacement to the emergency or similar supply from the total prescription. The pharmacy may not bill two prescriptions, one to replace the emergency or similar supply, and another to satisfy the balance of the patient's requirements.

(2) Noncompounded drugs, other than influenza vaccine

The dispensing fee for noncompounded drugs shall be one dollar eighty cents for claims with dates of service on or after January 1, 2010.

(3) Compounded drugs

(a) All compounded drugs, including total parenteral nutrition, must be submitted with a compound code value of "2".

(b) Infusion compounds include intravenous (IV) therapy for chemotherapy, pain management and antibiotics. Claims submitted for infusion compounds will receive a dispensing fee of ten dollars per day, with a maximum dispensing fee of seventy dollars.

(c) Total parenteral nutrition claims will receive a dispensing fee of fifteen dollars per day, with a maximum dispensing fee of one hundred fifty dollars.

(d) Compounded drugs that are not infusion compounds or total parenteral nutrition claims will receive a single six dollar dispensing fee per prescription.

(e) For purpose of documentation for the Ohio board of pharmacy, providers must be able to retrieve and document all components of a compounded drug.

(4) Seasonal and pandemic influenza vaccine

(a) When dispensed to a resident of a NF or ICF-MR, the dispensing fee for seasonal and pandemic influenza vaccine shall be fifty cents.

(b) When dispensed to a medicaid consumer who is not a resident of a NF or ICF-MR, and the vaccine is administered at the pharmacy, the administration fee shall be ten dollars.

Effective: 07/01/2011
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 9/19/77, 12/21/77 (Emer), 12/30/77, 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, 5/1/02, 3/31/03 (Emer), 6/12/03, 10/16/03 (Emer), 1/1/04, 10/1/05, 12/31/07, 10/1/09 (Emer), 12/29/09, 1/2/10, 10/1/10

5160-9-06 Prescription billing and recordkeeping requirements.

(A) The pharmacy claim to the Ohio department of job and family services (ODJFS) or its designee, the pharmacy point-of-sale vendor, must reflect the actual national drug code (NDC) on the container from which the product was dispensed except for unit dose products that must be billed in accordance with paragraph (G) of rule 5101:3-9-03 of the Administrative Code.

(B) All records of prescriptions must comply with federal and state regulations and shall be retained by the provider for a period of six years from the date of reimbursement of the claim and if an audit is initiated during this time, records must be retained until the audit is resolved.

(C) For a pharmacy claim to be eligible for reimbursement by ODJFS, any prescription executed in written (and non-electronic) format must be executed on a tamper-resistant form.

(1) To be considered tamper resistant

, a prescription form must contain all of the following three characteristics:

(a) One or more features designed to prevent unauthorized copying of a completed or blank prescription form;

(b) One or more features designed to prevent the erasure or modification of information written on the prescription by the prescriber; and

(c) One or more features designed to prevent the use of counterfeit prescription forms.

(2) The tamper-resistant requirement applies to all written prescriptions presented at the pharmacy when ODJFS pays any part of the claim, including when ODJFS is not the primary payer, in accordance with paragraphs (F) and (G) of this rule.

(3) The tamper-resistant requirement does not apply in the following situations:

(a) Prescriptions transmitted to the pharmacy via an electronic prescription transmission system, facsimile device, or telephone, in accordance with rules promulgated by the state board of pharmacy in agency 4729 of the Administrative Code;

(b) Orders for medications administered in a provider setting and billed by the administering provider in accordance with paragraph (I) of rule 5101:3-9-03 of the Administrative Code; or

(c) Orders for medications administered in a nursing facility (NF) or intermediate care facility for the mentally retarded (ICF-MR), if the order is written in the patient's medical record and given by medical staff directly to the pharmacy. The prescription is considered tamper resistant if the patient does not have opportunity to handle the written order.

(4) If a written prescription that is not tamper resistant is presented at the pharmacy , the pharmacy may fill the prescription on an emergency basis and obtain a compliant tamper-resistant replacement from the prescriber within seventy-two hours of dispensing.

(a) A tamper-resistant replacement may be obtained via any of the following methods:

(i) Telephone verification from the prescriber or prescriber's staff, documented on the prescription with the name of the person at the prescriber's office verifying the prescription, date of verification, and identification of the pharmacist or pharmacy staff member requesting verification;

(ii) Obtaining a copy of the prescription from the prescriber via facsimile device;

(iii) Obtaining an electronic prescription from the prescriber; or

(iv) Obtaining a replacement written prescription from the prescriber on a tamper-resistant form.

(b) The replacement tamper-resistant prescription shall be filed with the original, non-tamper-resistant prescription.

(c) The dispensing pharmacist shall use professional judgment to define an emergency situation.

(5) When it is determined that a consumer is retroactively eligible, and the consumer's original or refill prescription was filled during a period when the consumer is retroactively eligible, the pharmacy must ensure that the original prescription was tamper resistant before billing the pharmacy claim to ODJFS.

(a) If the prescription meets the provisions of paragraph (C)(3) of this rule, the tamper-resistant requirement does not apply.

(b) If the original prescription was not tamper resistant, the pharmacy may obtain a tamper-resistant replacement as described in paragraphs (C)(4)(a) and (C)(4)(b) of this rule.

(D) The quantity of the product dispensed must be submitted in a metric decimal format for payment.

(E) Voids and reversals

(1) Return to stock

(a) When patients fail to pick up their prescriptions, pharmacies must reverse the claim submitted to ODJFS as soon as possible. Reversing a claim within fourteen days will simplify claim reconciliation for providers.

(b) When prescriptions have been dispensed to a resident of a

NF or ICF-MR and there is an unutilized portion of a legally redispensable drug remaining, the drug must either be:

(i) Destroyed; or

(ii) Returned to the pharmacy to be redispensed and the product cost, not including the dispensing fee, must be credited to ODJFS. This shall be done by voiding or reversing the original claim and submitting a new claim for the utilized amount plus dispensing fee.

(2) Voids, reversals, and replacement claims for other reasons

(a) Original claims shall be submitted within three hundred sixty-five days of the date of service. Claims may be reversed, voided, or replaced (i.e., re-billed) at any time within the first three hundred sixty-five days after the date of service.

(b) Claims may be reversed, voided, or replaced beyond three hundred sixty-five days after the date of service in the following circumstances:

(i) Adjudicated paid claims may be reversed and replaced (i.e., re-billed) beyond three hundred sixty-five days after the date of service if the adjudication date of the replacement claim is within ninety days after the date of original claim payment.

(ii) Adjudicated denied claims may be replaced (i.e., re-billed) beyond three hundred sixty-five days after the date of service if the adjudication date of the replacement claim is within ninety days after the date of adjudication of an original denied claim.

(iii) Adjudicated paid claims may be reversed or voided beyond three hundred sixty-five days after the date of service if the adjudication date of the reversal or void is within five hundred forty-five days after the date of original claim payment.

(F) Third party liability

(1) In accordance with rules 5101:3-1-17.2 and 5101:3-1-08 of the Administrative Code, ODJFS is the payer of last resort.

(2) ODJFS shall reimburse the difference between the third party payment and the medicaid calculated allowable minus any co-payments imposed by medicaid in accordance with rule 5101:3-1-09 of the Administrative Code. This shall be considered payment in full.

(G) Medicare part B-covered services

Drugs covered by medicare part B for dually eligible consumers must be billed to medicare. ODJFS shall reimburse the medicare part B cost sharing in accordance with rule 5101:3-1-05 of the Administrative Code.

(H) Medicare part D-covered services

Drugs that are covered or may be covered by medicare part D for dually eligible consumers must be billed to the appropriate medicare part D prescription drug plan (PDP) and are not covered by medicaid. Medicare cost sharing for medicare part D services is not reimbursable by ODJFS.

(I) Point-of-sale claims processing

(1) Pharmacy claims must be billed through the electronic point-of-sale system provided by the ODJFS pharmacy point-of-sale vendor or using a paper claim format as approved by the pharmacy point-of-sale vendor.

(2) Batch process claims are not accepted.

Effective: 10/01/2010
R.C. 119.032 review dates: 06/30/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 5111.02 , 5111.98
Rule Amplifies: 5111.01 , 5111.02 , 5111.021 , 5111.98
Prior Effective Dates: 4/7/77, 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, 8/30/01, 10/16/03 (Emer), 1/1/04, 1/1/06, 7/1/06, 4/1/08

5160-9-07 Drug review process.

(A) For a drug to be considered for inclusion in the appendix to rule 5160-9-12 of the Administrative Code, the following information may be requested from the manufacturer or labeler:

(1) Trade name of the drug.

(2) Generic name of the drug.

(3) National drug code number (NDC).

(4) Package sizes available.

(5) Strengths.

(6) Therapeutic use(s).

(7) List of therapeutic ingredients.

(8) Direct, average wholesale price, wholesale acquisition cost and average manufacturer price.

(9) Bioavailability and bioequivalency data.

(10) Letter(s) of approval of new drug application (NDA), or abbreviated new drug application (ANDA).

(11) Product labeling as approved by the food and drug administration.

(12) A statement of justification for inclusion in the appendix to rule 5160-9-12 of the Administrative Code including cost effectiveness and relative merits.

(B) Final determination by the Ohio Department of Medicaid (ODM) of a drug's inclusion on or removal from the appendix to rule 5160-9-12 of the Administrative Code will be based on a review and analysis of the information required in paragraph (A) of this rule in addition to an analysis of such factors as:

(1) Specific attributes and/or benefits of the drug.

(2) Availability and cost effectiveness of the drug in relation to alternative products.

(3) Availability of bioequivalent generic products.

(4) Provision of a supplemental rebate payment for a drug that reduces the acquisition cost.

Effective: 05/16/2014
R.C. 119.032 review dates: 02/14/2014 and 05/16/2019
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03
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 (Emerg), 4/13/89, 6/1/89, 7/1/94, 10/1/97, 2/3/00 (Emer), 5/1/00, 8/30/01, 3/31/03 (Emer), 6/12/03, 7/24/08

5160-9-09 Consumer co-payments for certain pharmacy medications.

(A) Consumers eligible for the medicaid program as defined in paragraph (B) of this rule will pay a three dollar co-payment for prescription medications not found in appendix A to rule 5101:3-9-12 of the Administrative Code, and a two dollar co-payment for selected trade name drugs as indicated in appendix A to rule 5101:3-9-12 of the Administrative Code.

(B) Consumers subject to co-payment for medications are identified as adults eligible under the medicaid program, age twenty-one and over. Co-payment requirements as contained in this rule are also subject to the provisions of rules 5101:3-1-09 and 5101:3-1-60 of the Administrative Code.

(C) Exclusions to the co-payment requirement for prescription medications as described in paragraph (A) of this rule are described in rule 5101:3-1-09 of the Administrative Code and as follows:

(1) Children. Prescriptions for medications given to eligible consumers under twenty-one years of age are excluded from co-payment. The Ohio department of job and family services (ODJFS) identifies those eligible consumers who are under age twenty-one through the ODJFS recipient master file (RMF) and excludes them from co-payment at the time the medication is dispensed. In the event that there is a dispute concerning the consumer's age, and the RMF and the client registry information system-enhanced (CRIS-E) are found to be in error, the consumer may be refunded any paid co-payment in accordance with rule 5101:3-1-60.2 of the Administrative Code.

(2) Pregnant women. Prescriptions for medications given to eligible pregnant women are excluded from co-payment during the woman's pregnancy and the post-partum period. The post-partum period is the immediate post-partum period that begins on the last day of pregnancy and extends through the end of the month in which the sixty day period following termination of pregnancy ends. Pregnant women may declare their pregnancy or their sixty day post-partum period at the time their prescription medication is dispensed and they will not be charged a co-payment for their medication.

(3) Institutionalized individuals. Prescriptions for medication given to any eligible consumer who is a resident in a long term care facility are excluded from co-payment. ODJFS identifies residents of long term care facilities (those living in nursing facilities (NFs) and intermediate care facilities for the mentally retarded (ICFs-MR) as defined in section 5111.20 of the Revised Code) through the RMF and excludes them from co-payment at the time the medication is dispensed.

(4) Hospice care. Prescriptions for medication given to any eligible consumer who is receiving hospice care are excluded from co-payment. ODJFS identifies consumers who are receiving hospice care in accordance with Chapter 5101:3-56 of the Administrative Code.

(5) Family planning. Prescriptions for medication given to an eligible consumer of child-bearing age for the purposes of family planning are excluded from co-payment. ODJFS identifies medications that qualify as family planning services in appendix A to rule 5101:3-9-12 of the Administrative Code and the ODJFS pharmacy point-of-sale vendor will exempt these medications from co-payment.

(6) Emergency services. Medications administered to an eligible consumer during emergency care provided in a hospital, clinic, office, or other facility that is equipped to furnish the required care, after the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) that the absence of immediate medical attention could reasonably be expected to result in placing the patient's health in serious jeopardy; serious impairment to bodily functions; or serious dysfunction of any bodily part or organ, are not subject to co-payment.

(7) Medications administered to an eligible consumer during a medical encounter provided in a hospital, clinic, office, or other facility, when the medication is a part of the evaluation and treatment of the condition, are not subject to co-payment.

(D) Prescriptions for medication given to an eligible consumer during a medical encounter provided in the emergency department or other hospital setting, clinic, office, or other facility as a result of the evaluation and treatment of the condition, to be filled at a pharmacy located at the facility or at an outside location, are subject to co-payment under the conditions described in paragraphs (A) and (B) of this rule.

(E) No provider of pharmacy services may deny medication to a consumer because the consumer is unable to pay the co-payment, if the consumer is eligible for medicaid coverage of the medication. Consumers who are unable to pay their co-payment may declare to the provider their inability to pay and obtain the medication without paying their co-payment. Consumers who declare their inability to pay remain liable for the co-payment. The provider may bill the consumer for the co-payment or request payment for a prior uncollected co-payment. The provider may not deny subsequent medications that may be covered by medicaid based on a consumer's failure to pay prior co-payments except as described in paragraph (B)(5) of rule 5101:3-1-09 of the Administrative Code.

(F) In accordance with rule 5101:3-1-08 of the Administrative Code, providers are expected to take reasonable measures to ascertain any third-party resource available to the consumer and to file a claim with that third party. ODJFS shall reimburse the difference between the third party payment and the medicaid calculated allowable minus the applicable co-payment as defined in paragraph (A) of this rule.

Effective: 02/01/2010
R.C. 119.032 review dates: 11/17/2009 and 02/01/2015
Promulgated Under: 119.03
Statutory Authority: 5111.02 , 5111.0112
Rule Amplifies: 5111.01 , 5111.02 , 5111.0112 , section 309.10 of Am.
Sub. HB 1 of the 128th General Assembly Prior Effective Dates: 1/1/04, 1/1/06

5160-9-12 Ohio department of medicaid (ODM) list of drugs covered without prior authorization.

(A) The drug products covered under the medicaid program without prior authorization are specified in the appendix to this rule. The table includes four columns to indicate drug coverage.

(1) Drug class. This column describes the therapeutic class of drug.

(2) Drug name. This column names each drug covered under the medicaid program without prior authorization.

(3) Co-payment. This column indicates the medicaid co-payment that applies to each drug in accordance with rule 5160-9-09 of the Administrative Code. "2" indicates that a two dollar co-payment applies, "0" indicates that zero co-payment applies, and "*" indicates that the drug is only available without prior authorization for children who are exempt from co-payment requirements under rule 5160-9-09 of the Administrative Code. If the drug is prior authorized for an adult, the appropriate co-payment for prior authorized drugs will apply.

(4) Covered for dual eligible. This column indicates whether the drug is covered under the medicaid program for a consumer who is a dual eligible as defined in rule 5160-1-05 of the Administrative Code. "Y" indicates that the drug is covered for a dual eligible and "N" indicates that the drug is not covered for a dual eligible.

(B) Revisions to the appendix to this rule shall be filed pursuant to Chapter 119. of the Revised Code unless the revisions are required to comply with rule 5160-9-03 of the Administrative Code, state statute, and/or federal statute or regulations relating to federal financial participation in the medicaid program.

(C) Drugs not listed in the appendix to this rule that are classified in the following drug classes will not require prior authorization if the pharmacy claim indicates that the prescriber is a physician who has registered his or her psychiatry specialty with ODM, and when the dosage form of the drug prescribed is a standard tablet or capsule:

(1) Selective serotonin reuptake inhibitor (SSRI);

(2) Alpha-2 receptor antagonist;

(3) Selective serotonin-norepinephrine reuptake inhibitor (SNRI);

(4) Selective norepinephrine and dopamine reuptake inhibitor (NDRI);

(5) Monoamine oxidase inhibitor, non-selective and irreversible;

(6) Antipsychotic, atypical, dopamine and serotonin antagonist;

(7) Antipsychotic, atypical, D2 partial agonist/5HT mixed; or

(8) SSRI and antipsychotic, dopamine and serotonin antagonist combination.

Click to view Appendix

Effective: 02/24/2014
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5162.03 , 5162.031 , 5162.20 , 5164.02 , 5164.755 , 5164.7510
Prior Effective Dates: 11/1/85 (Emer), 1/31/86, 5/1/86, 8/1/86, 11/1/86, 2/2/87 (Emer), 5/1/87, 8/1/87, 10/29/87 (Emer), 1/20/88 (Emer), 4/18/88, 8/6/88, 11/1/88, 1/19/89, 1/20/89 (Emer), 4/20/89, 6/9/89 (Emer), 8/3/89, 11/1/89, 2/1/90, 5/1/90, 8/1/90 (Emer), 11/1/90, 12/31/90 (Emer), 3/31/91, 8/22/91, 2/10/92, 7/11/92, 10/25/92, 4/1/93, 6/18/93, 11/11/93, 3/18/94, 8/25/94, 3/20/95, 5/25/95, 9/1/95, 2/1/96, 9/13/96, 3/22/97, 8/14/97, 1/23/98, 7/1/98, 1/1/99, 3/31/99, 7/1/99, 4/1/00, 11/12/00, 3/19/01, 8/30/01, 12/13/01, 3/21/02, 8/15/02, 11/22/02, 3/31/03 (Emer), 6/12/03, 9/30/03, 4/1/04, 10/1/04, 4/14/05, 10/1/05, 1/1/06, 7/1/06, 10/1/06, 7/10/07, 10/1/07, 3/20/08, 10/1/08, 7/1/09, 10/1/09, 10/1/10, 7/1/11, 10/1/11, 7/19/12, 10/1/12, 1/1/13, 11/1/13

5160-9-14 Pharmacy services: limited family planning benefit.

(A) Definitions

(1) "Family planning services" and "pregnancy prevention/contraceptive management services" are defined in rule 5101:3-21-02 of the Administrative Code.

(2) "Family planning-related services" are defined in rule 5101:3-21-02.3 of the Administrative Code.

(B) Individuals who meet the eligibility criteria in rule 5101:1-41-40 of the Administrative Code have a limited medicaid benefit as described in rule 5101:3-21-02.3 of the Administrative Code. Pharmacy services are limited to the following:

(1) Pregnancy prevention/contraceptive management

(a) Drugs listed in appendix A to rule 5101:3-9-12 of the Administrative Code that are included in the following drug classes:

(i) G8A - Contraceptives, oral; and

(ii) G8F - Contraceptive, transdermal; and

(iii) G9B - Contraceptives, intravaginal, systemic; and

(b) Contraceptive supplies listed in appendix A to rule 5101:3-9-02 of the Administrative Code.

(2) Family planning-related drugs used to treat sexually transmitted infections (STIs) other than human immunodeficiency virus (HIV) and hepatitis that are listed in the appendix to this rule. These drugs are included in the recommended treatment regimens published by the federal centers for disease control and prevention.

(a) The appendix to this rule includes three columns to indicate drug coverage:

(i) Drug class. This column describes the therapeutic class of drug.

(ii) Drug name. This column names each drug covered for treatment of STIs under the limited family planning benefit.

(iii) Co-payment. This column indicates the medicaid co-payment that applies to each drug in accordance with rule 5101:3-9-09 of the Administrative Code."2" indicates that a two dollar co-payment applies, "0" indicates that zero co-payment applies.

(b) The prescriber must include family planning diagnosis in the V25 series on all prescriptions issued for consumers enrolled in the limited family planning benefit for drugs used for the treatment of STIs.

(c) The pharmacy claim must include the family planning diagnosis indicated on the prescription.

(C) The provisions of rules 5101:3-9-01 to 5101:3-9-06 and 5101:3-9-09 of the Administrative Code apply to claims billed under the limited family planning benefit.

Click to view Appendix

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.0112 , 5111.02 , 5111.021