Chapter 5160-9 | Pharmacy Services

Rule 5160-9-01 | Eligible providers of pharmacy services and cost of dispensing survey.

• Effective: April 1, 2017
• Promulgated Under: 119.03

(A) Provider types eligible for payment for pharmacy services:

(1) 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:

(a) Has a valid drug enforcement agency (DEA) registration; and

(b) Has a pharmacist as the "responsible person," as defined in rule 4729-5-11 of the Administrative Code; and

(c) Complies with eligible provider rules 5160-1-17 to 5160-1-17.11 of the Administrative Code and signs a provider agreement with the Ohio department of medicaid (ODM).

(2) A "hospital" provider acting as a pharmacy in accordance with paragraphs (A)(1)(a) to (A)(1)(c) of this rule can obtain a "pharmacy" specialty designation and bill for self-administered take-home drugs.

(3) "Clinic" providers that have a valid medicaid provider agreement and have met the criteria under the Revised Code to personally furnish pharmaceuticals but are not eligible to become a "pharmacy provider" as defined in paragraph (A)(1) of this rule, are eligible to apply for a "pharmacy" specialty designation and bill for self-administered take-home drugs.

(B) Provider types described in paragaph (A) of this rule are required to submit a complete response to the cost of dispensing survey conducted according to section 5164.752 of the Revised Code.

(1) A complete response to the cost of dispensing survey includes supplying complete information about the terminal distributor for, at the least, all of the following categories:

(a) Demographics;

(b) Number of prescriptions dispensed annually, broken out by medicaid fee-for-service and other payers and including a total volume for the location;

(c) Sales and cost of goods sold;

(d) Direct expenses;

(e) Overhead expenses; and

(f) Certification that the person who submits the survey believes the information to be true, correct, and complete.

(2) Providers that do not submit a complete response to the cost of dispensing survey may be paid a lower professional dispensing fee (PDF) in accordance with paragraph (E)(1) of rule 5160-9-05 of the Administrative Code.

(3) Newly-enrolled providers shall be assigned to the dispensing fee described in paragraph (E)(1)(b)(vi) of rule 5160-9-05 of the Administrative Code, unless the provider received the new provider number due to a change in ownership. In that situation, the department shall use the number of prescriptions reported by the previous owner to determine the PDF. In a situation other than a change of ownership, a provider is newly-enrolled if the date of approval of an application to enroll as a provider, or the date of approval of a pharmacy specialty designation, is less than ninety days prior to the distribution of the most recently-conducted cost of dispensing survey. The date of approval is not the effective date of the provider agreement or specialty designation when the effective date is made retroactive by ODM.

(4) If a provider experiences a change in prescription volume during the first nine months following the implementation of a PDF category significant enough that it would result in the provider falling into a different PDF category, the provider may submit a written request with supporting documentation to ODM, no later than the thirtieth day of April of the first year, requesting assignment to a different category. If the supporting documentation justifies an adjustment, ODM will assign a new PDF category effective the first day of July for the second year.

(5) Providers that did not submit a complete response to the cost of dispensing survey conducted in 2016 may submit an attestation of the number of prescriptions filled in the provider's most recently completed fiscal year or other twelve-month period beginning no earlier than January 1, 2015. The attestation shall follow the format posted on the ODM website at http://pharmacy.medicaid.ohio.gov.

Supplemental Information

Authorized By: 5164.02
Amplifies: 5162.03, 5164.02, 5164.752
Five Year Review Date: 9/28/2022
Prior Effective Dates: 11/1/1986, 2/1/1988, 7/1/1994, 5/1/2000

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

• Effective: April 1, 2017
• Promulgated Under: 119.03

(A) Eligible pharmacies in the Ohio medicaid program may bill for medical supplies and durable medical equipment in accordance with Chapter 5160-10 of the Administrative Code, with the following stipulations:

(1) The provider must apply to, and be approved by, 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) Claims submitted for medical supplies/durable medical equipment must be billed in the appropriate claim format 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 5160-10 of the Administrative Code.

(D) Only eligible providers of pharmacy services as described in rule 5160-9-01 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 5160-10 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 payment.

(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 individuals eligible for medicaid and may be billed directly to ODM by the provider. "H" indicates that the item may be billed directly to ODM only if the item is intended for use by the individual in their personal residence, with the exception of individuals who reside in a nursing facility (NF), as defined in section 5165.01 of the Revised Code, or intermediate care facility for individuals with intellectual disabilities (ICF/IID), as defined in section 5124.01 of the Revised Code. For individuals residing in a NF or ICF/IID, the supply is the responsibility of the NF or ICF/IID and is included in the NF or ICF/IID facility per diem payment.

(3) Covered for dual eligible. This column indicates whether the supply is covered under the medicaid program for an individual who is a dual eligible as defined in rule 5160-1-05 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) Maximum payment. This column indicates the medicaid maximum payment per item as defined in rule 5160-1-60 of the Administrative Code. Supplies with "*" in this column indicate that maximum payment will be calculated based on the wholesale acquisition cost (WAC) as defined in rule 5160-9-05 of the Administrative Code.

(a) For dates of service before the effective date of this rule, the maximum payment shall be one hundred seven per cent of WAC.

(b) For dates of service on or after the effective date of this rule, the maximum payment shall be one hundred per cent of WAC.

(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. Payment shall be the lesser of the submitted charge or the calculated allowable. The calculated allowable is the medicaid maximum payment as described in paragraph (E)(5)(a) of this rule. For dates of service on or after the effective date of this rule, the calculated allowable is the medicaid maximum payment as described in paragraph (E)(5)(b) of this rule plus the professional dispensing fee applicable to the provider as described in paragraph (E)(1)(b) of rule 5160-9-05 of the Administrative Code.

(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 5160-10-01 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 5160-1-05 of the Administrative Code may be billed by any provider eligible for the medicare crossover process.

(H) Preferred medical supplies

(1) Selected products from the medical supply categories included in the appendix to this rule have been designated as preferred brands, as specified on the ODM web site at http://pharmacy.medicaid.ohio.gov.

(2) Products that have not been designated 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 shall document medical necessity for the non-preferred brand and why a preferred brand 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.

View Appendix

Supplemental Information

Authorized By: 5164.02
Amplifies: 5162.03, 5164.02, 5164.70
Five Year Review Date: 9/28/2022
Prior Effective Dates: 4/7/1977, 12/21/1977, 10/1/1997

Rule 5160-9-03 | Pharmacy services: covered drugs and associated limitations.

• Effective: January 1, 2020
• Promulgated Under: 119.03

(A) Covered prescribed drugs

Drugs covered by the Ohio department of medicaid (ODM) pharmacy program, or a managed care plan as defined in rule 5160-26-01 of the Administrative Code, are prescribed drugs as defined in rule 5160-9-05 of the Administrative Code that are dispensed to an eligible patient for use in the patient's residence, including a nursing facility (NF), as defined in section 5165.01 of the Revised Code, or intermediate care facility for individuals with intellectual disabilities (ICF/IID), as defined in section 5124.01 of the Revised Code, and fall into one of the following categories:

(1) "Dangerous drugs" as defined in section 4729.01 of the Revised Code that meet the definition of a "covered outpatient drug (COD)" as defined in 42 C.F.R. 447.502 (October 1, 2019) that are not non-covered drugs as described in paragraph (B) of this rule.

(2) Over-the-counter drugs listed in accordance with paragraph (C) of this rule.

(3) Compounded prescriptions in accordance with paragraph (E) of this rule, when compounded with ingredients described in paragraphs (A)(1) to (A)(2) of this rule or with active pharmaceutical ingredients (API) and excipients listed on the ODM pharmacy program web site at http://pharmacy.medicaid.ohio.gov.

(4) Vaccines, inoculations, and immunizations, Vaccines, inoculations, and immunizations, other than seasonal and pandemic influenza vaccines, are covered under fee-for-service by the ODM pharmacy program only for residents of a NF or ICF/IID; otherwise these services shall be billed as physician services in accordance with Chapter 5160-4 of the Administrative Code. Seasonal and pandemic influenza vaccine may be billed by the pharmacy for an individual who is not a resident of a NF or ICF/IID if the vaccine will be administered at the pharmacy, or for an individual who is a resident of a NF or ICF/IID to be administered by facility staff.

(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 are eligible to be covered by medicare part D, when prescribed for an individual who is eligible for medicare, unless medicaid coverage for a dual eligible is indicated in accordance with paragraph (C) of this rule.

(6) Over-the-counter drugs that are not listed in accordance with paragraph (C) of this rule.

(7) 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) The prescribed drugs covered under the ODM pharmacy program without prior authorization are specified on the ODM web site at http://pharmacy.medicaid.ohio.gov. This list indicates the drugs that require co-payments in accordance with rule 5160-9-09 of the Administrative Code, and specifies whether the drug is covered for a dual eligible as described in rule 5160-1-05 of the Administrative Code. Drugs not listed that meet the requirements of paragraph (A)(1) of this rule and are antidepressants or antipsychotics 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.

(D) Prior authorization

Dangerous drugs not listed in accordance with paragraph (C) of this rule that are medically necessary for treatment require prior authorization; however, noncovered drugs listed in paragraphs (B)(1) to (B)(6) of this rule and APIs and excipients not on the list described in paragraph (A)(3) 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 (January 1, 2020), 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 COD in an emergency situation.

(2) Drugs not listed in accordance with paragraph (C) of this rule may be covered with prior authorization if medical necessity is documented, the drug is not excluded per paragraphs (B)(1) to (B)(6) of this rule, and a drug that does not require prior authorization cannot be used.

(3) Prior authorization must be obtained from ODM or its designee before the drug claim may be paid. All requests must be submitted in accordance with instructions issued by ODM or its designee.

(a) Only the prescribing provider or a member of the prescribing provider's staff may request prior authorization except as described in paragraph (D)(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 that do not require prior authorization can be administered through a tube. A pharmacist may also request prior authorization of a seventy-two-hour supply of a dangerous drug that is a COD in an emergency situation if the prescribing provider or prescribing providers staff is not available to request prior authorization.

(4) Drugs in therapeutic classes that are covered or are eligible to be covered under medicare part D are not available for prior authorization for an individual who is eligible for medicare. Prior authorization may be requested for drugs in drug classes that may be covered by medicaid for a dual eligible as indicated in the list described in paragraph (C) of this rule 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.

(E) Compounded drugs

(1) Compounded drugs will be covered if at least one ingredient meets the requirements of paragraph (A) of this rule and the individual's medical need cannot be met by a covered product that is a COD.

(2) Compounded drug claims must be submitted to ODM or its designee using the national drug code (NDC) for each ingredient that is a part of the compound.

(3) An ingredient in a compounded drug that is both a COD and a dangerous drug, not listed in accordance with paragraph (C) of this rule, will require prior authorization. If a prior authorization is not approved or if an ingredient is not eligible for authorization (i.e., not covered as described in paragraph (A) of this rule, excluded from coverage as described in paragraph (B) of this rule, or excluded from separate payment as described in paragraph (I) of this rule), the pharmacy provider may elect to receive payment only for those ingredients in the compound that are directly payable by ODM, in accordance with billing instructions issued by ODM or its designee.

(F) Dispensing limitations

(1) Days supply limits

(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 limits

Maximum prescription quantities are listed on the ODM pharmacy program web site 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) Maximum equivalent daily dose limits

Maximum equivalent daily doses are listed on the ODM pharmacy program web site and establish the highest equivalent dose of certain therapeutic classes (e.g., opioid drugs expressed in morphine equivalent) that may be dispensed when equivalent doses of all drugs in the therapeutic class are summed.

(4) Maximum prescription claim limits

Maximum prescription claim limits are listed on the ODM pharmacy program web site and establish the maximum number of claims for drugs that are therapeutic duplicates that shall be paid within specified time limits (e.g., no more than five claims for opioid drugs within thirty days).

(5) Claims submitted that exceed the limits described in paragraphs (F)(1) to (F)(4) of this rule shall be denied. Denials may be overridden by ODM or its designee in cases where medical necessity has been determined through the prior authorization process.

(G) Refill prescriptions

(1) Unless the pharmacy is submitting an early refill for a shortened days supply to support medication synchronization described in section 5164.7511 of the Revised Code and the claim is submitted pursuant to billing instructions for medication synchronization issued by ODM or its designee, the following limitations apply:

(a) Refills of drugs not scheduled by the federal drug enforcement administration (DEA) requested before eighty per cent of the days supply has been utilized will be denied.

(b) Refills of drugs scheduled by the DEA requested before ninety per cent of the days supply has been utilized will be denied.

(2) If a new prescription has been issued by the prescriber that requires increased dosing frequency, the existing prescription must be utilized until the days supply per cent threshold has been met, calculated using the increased dosing frequency.

(3) Denials may be overridden by ODM or its designee for the following documented reasons:

(a) Previous supply was lost, stolen, or destroyed. ODM 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.

(b) Previous claim was submitted with wrong days supply.

(c) Vacation or travel.

(d) Multiple supplies of the same medication are needed, for example in a school or workshop setting. Multiple supplies are limited to products that cannot be broken into multiple containers, such as inhalers or other unit-of-use containers.

(e) Hospital or police kept the medication.

(f) Brand or generic was ineffective and the patient was switched to generic or brand.

(H) Selected pharmaceuticals, including injectable drugs, are not covered under the pharmacy program if they are administered in a provider setting, other than a NF, ICF/IID, or pharmacy.

(1) Long-acting injectable pharmaceuticals used for substance use disorder or mental health conditions may be billed by the pharmacy for administration in a provider setting 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 (H)(1) of this rule administered in the physician's office must be purchased by the physician's office and billed as a professional service claim.

(I) Selected over-the-counter drugs are not separately payable when prescribed for an individual residing in a NF. Such drugs are the responsibility of the NF and are included in the facility per diem payment. The over-the-counter drugs not separately payable are those that are classified into the following drug classes:

(1) Analgesics, including urinary analgesics;

(2) APIs and excipients used in compounded prescriptions;

(3) Cough and cold preparations and antihistamines;

(4) Ear preparations;

(5) Gastrointestinal agents, except histamine-2 receptor antagonists, proton pump inhibitors, and loperamide;

(6) Hemorrhoidal preparations;

(7) Nasal preparations, except nasal corticosteroids;

(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.

Supplemental Information

Authorized By: 5160.34, 5162.031, 5164.02
Amplifies: 5160.34, 5162.03, 5162.031, 5162.20, 5164.02, 5164.03, 5164.70, 5164.754, 5164.755, 5164.7510, 5164.7511, 5165.01, 5165.47
Five Year Review Date: 9/28/2022
Prior Effective Dates: 1/31/1986, 8/1/1986, 8/1/1987, 4/18/1988, 8/6/1988, 1/20/1989 (Emer.), 6/9/1989 (Emer.), 8/3/1989, 11/1/1989, 7/11/1992, 6/18/1993, 7/1/1994, 3/20/1995, 9/1/1995, 1/1/1999, 3/31/1999, 7/1/1999, 8/30/2001, 11/22/2002, 3/31/2003 (Emer.), 10/1/2007, 10/1/2009, 11/1/2013

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

• Effective: April 1, 2017
• Promulgated Under: 119.03

(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;

(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 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

(1) Membership

(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.

(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 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.

Supplemental Information

Authorized By: 5164.02
Amplifies: 5162.03, 5164.02, 5164.759
Five Year Review Date: 9/28/2022
Prior Effective Dates: 1/1/1993, 10/5/2013

Rule 5160-9-05 | Pharmacy services: payment for prescribed drugs.

• Effective: April 24, 2021
• Promulgated Under: 119.03

(A) Definitions.

(1) "340B ceiling price" means the highest price allowed to be charged by a manufacturer to a 340B covered entity as described in section 340B(a)(4) of the "Public Health Service Act," 42 U.S.C. 256b(a)(4) (in effect as of January 7, 2011).

(2) "Actual acquisition cost (AAC)" means the best determination by the Ohio department of medicaid (ODM) of the actual amount the provider paid to purchase the prescribed drug. ODM acquires AAC data through one or more of the following: national survey of retail pharmacy providers, e.g., national average drug acquisition cost (NADAC) rate process, states' surveys of retail pharmacy providers, and published compendia prices, e.g., wholesale acquisition cost (WAC).

(3) "Administration fee" means the maximum amount payable to a provider to administer a vaccine or injectable drug that is payable under this chapter and authorized to be administered by a pharmacist or pharmacy intern in accordance with section 4729.45 of the Revised Code and the rules promulgated thereunder.

(4) "Calculated allowable" means the sum of the ingredient cost plus any applicable administration fee or professional dispensing fee.

(5) "Equivalent drug product" means drug products with the same active ingredient, strength, and dosage form.

(6) "Equivalent generic drug products" means equivalent drug products that are identified by the medicaid drug rebate program (MDRP) drug product data files as non-innovator products. MDRP files are available on the federal centers for medicare and medicaid services (CMS) web site at https://www.medicaid.gov.

(7) "Ingredient cost" means the portion of the total medicaid payment amount attributable to the cost of the drug product, or in the case of a compound drug, the sum of the cost of the ingredients that are covered in accordance with rule 5160-9-03 of the Administrative Code.

(8) "Long-term care facility (LTCF)" means a nursing facility as defined in section 5165.01 of the Revised Code or intermediate care facility for individuals with intellectual disabilities as defined in section 5124.01 of the Revised Code.

(9) "NADAC" means the rate determined by the CMS to be the average AAC for retail community pharmacies. NADAC rates are on the CMS website at https://www.medicaid.gov.

(10) "Prescribed drug" has the same meaning as in section 5164.01 of the Revised Code.

(11) "Professional dispensing fee (PDF)" means the fee or fees determined pursuant to section 5164.753 of the Revised Code and set forth in this rule.

(12) "State maximum allowable cost (SMAC)" means the maximum amount determined by ODM, based upon an estimate of the statewide AAC for a particular equivalent generic drug group, to be paid to Ohio medicaid providers for an equivalent generic drug group.

(13) "WAC" means the amount reported by a pharmaceutical manufacturer to pharmacy pricing compendia as the list price for a drug and may not represent the actual price of a particular transaction.

(B) Payment for prescribed drugs is the lesser of the provider's billed charges or the calculated allowable, after any coordination of benefits is applied as described in paragraph (F) of this rule. For prescribed drugs that are subject to a co-payment, the amount paid by ODM will be decreased by the amount equal to the co-payment that is to be billed to the individual in accordance with rules 5160-1-09 and 5160-9-09 of the Administrative Code.

(C) The ingredient cost portion of the calculated allowable shall be determined in accordance with the following criteria:

(1) No ingredient cost shall be allowed for a pandemic vaccine that is provided by the Ohio department of health or other government entity at no cost to the provider.

(2) For dates of service on or after April 1, 2017, for any drug purchased under the 340B program, the ingredient cost is the 340B ceiling price. If the 340B ceiling price is not available, the ingredient cost shall be fifty per cent of WAC.

(3) For dates of service on or after April 1, 2017, for a clotting factor, the ingredient cost shall be the payment limit shown in the current medicare part B drug pricing file, minus the furnishing fee assigned by medicare part B. The medicare part B pricing file is available at https://www.cms.gov.

(4) For all other ingredients not captured in paragraphs (C)(1) to (C)(3) of this rule:

(a) For dates of service prior to April 1, 2017, including drugs purchased under the 340B program and clotting factors:

(i) Maximum allowable cost (MAC) pharmaceuticals.

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

(b) ODM established a SMAC for additional selected drugs where either bio-equivalency of the drugs has been established or bio-inequivalency of the drugs has not been established. Payment for SMAC drugs shall be based on the sixty-fifth percentile of the estimated acquisition cost of all readily available equivalent generic drug products.

(ii) Estimated acquisition cost (EAC) pharmaceuticals. All products, other than those designated as MAC drugs, will be considered EAC drugs. Reimbursement will be based on the estimate of 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.

(b) For dates of service on or after April 1, 2017, the ingredient cost shall be the NADAC. If CMS has not published a NADAC for the ingredient for the date of service, the ingredient cost shall be the lesser of WAC or SMAC.

(D) For dates of service on or after April 1, 2017, the administration fee portion of the calculated allowable for a vaccine, except for a vaccine for COVID-19, or other injectable drug administered at the pharmacy shall be nineteen dollars thirty-five cents. The administration fee for a vaccine for COVID-19 equals the medicare rate. For dates of service prior to April 1, 2017, the administration fee shall be ten dollars. A vaccine, except for a vaccine for COVID-19, or other drug that is dispensed by a pharmacy to be administered outside the pharmacy, for example at a LTCF, is not eligible for a pharmacy administration fee but may be eligible for a professional dispensing fee.

(E) The PDF portion of the calculated allowable shall be determined in accordance with the following criteria:

(1) Non-compounded drugs.

(a) For dates of service prior to April 1, 2017, only pharmacy and hospital providers as defined in rule 5160-9-01 of the Administrative Code are eligible to receive a dispensing or administration fee. The dispensing fee shall be one dollar eighty cents.

(b) For dates of service on or after April 1, 2017, the PDF paid to a provider for dispensing a non-compounded drug shall be assigned based on the total number of prescriptions filled by the provider during the provider's last completed fiscal year prior to completing the survey required by rule 5160-9-01 of the Administrative Code and reported on the survey. The PDF shall be assigned in accordance with the following criteria:

(i) For providers reporting fewer than fifty thousand prescriptions, thirteen dollars and sixty-four cents.

(ii) For providers reporting between fifty thousand and seventy-four thousand nine hundred ninety-nine prescriptions, ten dollars and eighty cents.

(iii) For providers reporting between seventy-five thousand and ninety-nine thousand nine hundred ninety-nine prescriptions, nine dollars and fifty-one cents.

(iv) For providers reporting one hundred thousand or more prescriptions, eight dollars and thirty cents.

(v) For a provider that failed to submit a complete response to the cost of dispensing survey required by rule 5160-9-01 of the Administrative Code for the previous reporting period, eight dollars and thirty cents.

(vi) For providers newly enrolled as medicaid providers as described in rule 5160-9-01 of the Administrative Code, the PDF shall be as follows:

(a) For a new provider located in Ohio, the provider shall be assigned a PDF of thirteen dollars and sixty-four cents.

(b) For a new provider located outside of Ohio, the provider shall be assigned a PDF of eight dollars and thirty cents.

(2) Compounded drugs. The PDF paid to a provider for dispensing compounded drugs shall be paid in accordance with the following criteria:

(a) The PDF for claims for dispensing total parenteral nutrition (TPN) shall be fifteen dollars per one-day supply on the claim, with a maximum total PDF of one hundred fifty dollars for the claim. To qualify for the TPN PDF, the TPN compound must be mixed by the pharmacy to the final form under sterile conditions. If the products are mixed or activated at the point of administration by connecting components or breaking seals without the need for sterile conditions, the dispensing does not qualify for payment of the compounded PDF.

(b) For dates of service prior to April 1, 2017, claims submitted for infusion compounds will receive a dispensing fee of ten dollars per day, with a maximum dispensing fee of seventy dollars. Infusion compounds include intravenous (IV) therapy for chemotherapy, pain management and antibiotics.

(c) For dates of service on or after April 1, 2017, the PDF for dispensing sterile compounds, other than TPN, that are required to be sterile for a route of administration including inhaled, infused, instilled, implanted or injected, shall be ten dollars per days supply, with a minimum PDF of twenty dollars and a maximum of seventy dollars for the claim. To qualify for payment of the sterile compound PDF, the sterile compound must be mixed by the pharmacy to the final form under sterile conditions. Products that are mixed or activated at the point of administration by connecting components or breaking seals without the need for sterile conditions are not eligible for a sterile compound PDF.

(d) Compounded drugs other than TPN or sterile compounds.

(i) For dates of service prior to April 1, 2017, compounded drugs that are not infusion compounds or TPN claims will receive a single six dollar dispensing fee per prescription.

(ii) For dates of service on or after April 1, 2017, compounded drugs that are not eligible for the TPN or sterile compound PDF will receive the PDF determined under paragraph (E)(1)(b) of this rule.

(3) Vaccine or injectable drug dispensing that qualifies for payment of an administration fee shall not qualify for medicaid payment of a PDF.

(4) Notwithstanding paragraph (E)(1) of this rule, prescribed drugs, other than compounded drugs, dispensed to patients residing in LTCFs shall be limited to one PDF per patient, per equivalent product, per rolling twenty-five days. In the event that multiple supplies of an equivalent product are dispensed within twenty-five days, only the ingredient cost shall be paid. Exceptions to the one PDF per patient, per product rule are:

(a) Situations where the prescriber has ordered a second round of medication for an acute condition within the twenty-five day period.

(b) Situations where the prescriber has changed the dosage.

(c) Situations where the drug has been compromised by accident, for example contaminated or destroyed.

(d) Dispensing of controlled substances, which is limited to two PDFs per twenty-five days.

(F) Coordination of benefits.

(1) Claims for medicare part B cost sharing as described in rule 5160-1-05 of the Administrative Code shall be submitted using the medical claim format and shall not be payable under this chapter.

(2) No payment shall be made under this chapter for any drug that may be covered by medicare part D for an individual who is eligible for coverage by medicare part D, regardless of whether the individual is actually enrolled in a part D plan or the particular drug is covered by the individual's part D plan.

(3) Cost-sharing for claims involving neither medicare part B nor medicare part D is determined in accordance with rule 5160-1-08 of the Administrative Code.

Last updated April 24, 2021 at 1:41 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5162.03, 5162.20, 5164.70, 5164.752, 5164.753
Five Year Review Date: 9/28/2022
Prior Effective Dates: 4/7/1977, 9/19/1977, 12/30/1977, 2/1/1988, 6/1/1989, 10/1/1997, 5/1/2002, 3/31/2003 (Emer.), 12/31/2007

Rule 5160-9-06 | Pharmacy services: billing and recordkeeping requirements.

• Effective: April 1, 2017
• Promulgated Under: 119.03

(A) The pharmacy claim to the Ohio department of medicaid (ODM) 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.

(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 payment 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 payment by ODM, 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 ODM pays any part of the claim, including when ODM 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 (H) of rule 5160-9-03 of the Administrative Code; or

(c) Orders for medications administered in a nursing facility (NF) or intermediate care facility for individuals with intellectual disabilities (ICF/IID), 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 ODM.

(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) Claims for drugs purchased through the 340B drug discount program as defined in rule 5160-1-17.11 of the Administrative Code shall be submitted with the provider's actual acquisition cost plus cost of dispensing, and shall use the codes described in billing instructions issued by ODM or its designee.

(E) Voids and reversals

(1) Return to stock

(a) When patients fail to pick up their prescriptions, pharmacies must reverse the claim submitted to ODM as soon as possible.

(b) When prescriptions have been dispensed to a resident of a NF or ICF/IID 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 ODM. 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 5160-1-17.2 and 5160-1-08 of the Administrative Code, ODM is the payer of last resort.

(2) The provider's claim shall include the following indicators for each third-party payer as described in billing instructions issued by ODM or its designee.

(a) A payer identification code;

(b) Whether the claim was approved or denied, and if denied the reason for the denial;

(c) All amounts paid by third-party payers; and

(d) The patient responsibility amount assigned by each payer.

(G) Medicare part B-covered services

Drugs covered by medicare part B for dually eligible consumers shall first be billed by the provider to medicare. When appropriate, ODM shall pay the medicare part B cost sharing in accordance with rules 5160-1-05 to 5160-1-05.3 of the Administrative Code. Cost sharing for medicare part B services shall not be billed in a pharmacy claim format and shall be billed in accordance with the billing instructions issued by ODM for professional claims billed secondary to medicare part B or medicare part C.

(H) Medicare part D-covered services

Drugs that are covered or are eligible to be covered by medicare part D for dually eligible consumers are not covered by medicaid. Medicaid does not pay medicare cost sharing for medicare part D services.

Supplemental Information

Authorized By: 5162.031, 5164.02
Amplifies: 5162.031, 5164.02, 5164.03, 5164.70
Five Year Review Date: 9/28/2022
Prior Effective Dates: 12/21/1977, 2/3/2000 (Emer.), 1/1/2004

Rule 5160-9-07 | Pharmacy services: drug coverage review process.

• Effective: April 1, 2017
• Promulgated Under: 119.03

(A) For a drug to be considered for coverage without prior authorization in accordance with rule 5160-9-03 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 coverage without prior authorization 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 list described in paragraph (C) of rule 5160-9-03 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.

(C) Newly-marketed drugs

(1) New products with the same active ingredient, dosage form, and brand or generic designation as a product that is already covered by ODM will be added to coverage under the same conditions as the existing covered product.

(2) New products within a therapeutic category listed on the "ODM Preferred Drug List" (PDL) will be added to coverage with prior authorization using the same criteria outlined in the PDL document until the new product is reviewed by the ODM pharmacy and therapeutics committee.

(3) New products not within a therapeutic category listed on the ODM PDL will be added to coverage with prior authorization criteria consistent with the product labeling approved by the federal food and drug administration.

Supplemental Information

Authorized By: 5160.34, 5164.02
Amplifies: 5160.34, 5162.03, 5164.754, 5164.755, 5164.7510
Five Year Review Date: 9/28/2022
Prior Effective Dates: 4/13/1989, 8/30/2001

Rule 5160-9-09 | Pharmacy services: co-payments.

• Effective: April 1, 2017
• Promulgated Under: 119.03

(A) Adults eligible for the medicaid program will pay a three dollar co-payment for prescribed drugs that require prior authorization and a two dollar co-payment for selected trade name prescribed drugs as indicated in the list specified in paragraph (C) of rule 5160-9-03 of the Administrative Code.

(B) Rules 5160-1-09 and 5160-1-60 of the Administrative Code establish additional requirements regarding co-payments.

(C) Rule 5160-1-09 of the Administrative Code establishes exceptions to the requirement that an individual pay a co-payment.

(D) The exception established in paragraph (C)(4) of rule 5160-1-09 of the Administrative Code regarding emergency services does not extend to drugs prescribed to an individual during a visit to a hospital, clinic, office, emergency department, or other provider setting, that are intended to be used by the individual outside of the provider setting.

(E) No provider of pharmacy services may deny a prescribed drug to an individual eligible for medicaid coverage because the individual is unable to pay the co-payment. The provisions of paragraph (B) of rule 5160-1-09 of the Administrative Code apply to co-payments for prescribed drugs dispensed by a provider eligible to be paid for pharmacy services.

Last updated May 25, 2022 at 4:13 PM

Supplemental Information

Authorized By: 5162.20, 5164.02
Amplifies: 5162.03, 5162.20, 5164.02
Five Year Review Date: 9/28/2022
Prior Effective Dates: 1/1/2004