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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 5160-9 | Pharmacy Services

 
 
 
Rule
Rule 5160-9-01 | Pharmacy services: definitions.
 

(A) Covered drugs.

(1) "Compounded prescriptions" are prescription drugs made by combining two or more drugs. Active pharmaceutical ingredients (API) and excipients are listed on the ODM pharmacy program website at https://pharmacy.medicaid.ohio.gov.

(2) "Covered prescribed drug" means a drug covered by the Ohio department of medicaid (ODM) pharmacy program, or a managed care plan entity as defined in rule 5160-26-01 of the Administrative Code. Covered prescribed drugs are prescribed drugs that are dispensed to an eligible recipient for use in the recipient'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:

(a) "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 (November 19, 2021) that are not non-covered drugs.

(b) Over-the-counter (OTC) drugs listed on the "OH PBM OTC List" located on the ODM pharmacy website at https://pharmacy.medicaid.ohio.gov. The list is updated regularly and is recorded with the effective date included in each new version.

(B) "Noncovered drugs" are drugs that fall into one of the following categories for which coverage is not available through the Ohio medicaid pharmacy program as described in rule 5160-9-03 of the Administrative Code.

(C) Pricing.

(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 June 25, 2020).

(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 e.g., Ohio average acquisition cost (OAAC), 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 sections 4729.41 and 4729.45 of the Revised Code and the rules promulgated thereunder.

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

(5) "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) website at https://www.medicaid.gov.

(6) "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.

(7) "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.

(8) "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.

(9) "Ohio average acquistion cost (OAAC)" means pricing that more accurately reflects the actual acquisition cost for drugs for pharmacy providers in Ohio and is based on actual costs for the provider to purchase a drug.

(10) "Pharmacy pricing and audit consultant (PPAC)" means an organization which is responsible for pharmacy reimbursement calculation, benefit design, and pharmacy benefits management oversight and auditing.

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

(12) "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.

(13) "Single pharmacy benefits manager (SPBM)" means the pharmacy benefit manager selected by and under contract with the medicaid director under section 5167.24 of the Revised Code.

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

(15) "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.

(D) Provider types eligible for payment for pharmacy services.

(1) "Clinic" providers with valid medicaid provider agreements and meet the criteria under the Revised Code to personally furnish pharmaceuticals, but are not eligible to become a "pharmacy provider" are eligible to apply for a "pharmacy" specialty designation and bill for self-administered take-home drugs.

(2) 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:

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

(b) Has a pharmacist as the "responsible person," as defined in rule 4729:5-2-01 of the Administrative Code; and,

(c) Complies with eligible provider rules 5160-1-17 to 5160-1-17.9 of the Administrative Code and signs a provider agreement with the Ohio department of medicaid (ODM).

(3) A "hospital" provider acting as a pharmacy can obtain a "pharmacy" specialty designation and bill for self-administered take-home drugs.

Last updated February 16, 2024 at 8:10 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5164.02, 5164.03, 5164.752
Five Year Review Date: 2/16/2029
Prior Effective Dates: 4/7/1977, 7/8/1978, 10/1/1978, 6/1/1989, 2/3/2000 (Emer.), 5/1/2000, 7/1/2006, 10/1/2010
Rule 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 5160-10 of the Administrative Code, with the following stipulations:

(1) The provider must:

(a) Apply to, and be approved by, the Ohio department of medicaid (ODM) to be eligible to dispense medical supplies/durable medical equipment; and

(b) Use the same medicaid provider number as when billing for pharmaceuticals; and

(c) 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.

(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.

(B) Claims submission and billing.

(1) Medical supplies/durable medical equipment is billed in the appropriate claim format designated by ODM for those services.

(2) Medical supplies, durable medical equipment, prosthetic, and orthotic devices are billed by pharmacy providers in accordance with Chapter 5160-10 of the Administrative Code.

(3) Medical supplies are billed by eligible providers of pharmacy services only, except as specified in paragraph (C) of this rule. Eligible providers of pharmacy services may bill for these items without applying to ODM for eligibility for dispensation of medical supplies/durable equipment as described in Chapter 5160-10 of the Administrative Code. The list of supplies is located on the ODM pharmacy website at https://pharmacy.medicaid.ohio.gov.

(4) Quantities billed should equal the number of items dispensed (e.g., the quantity of test strips billed should equal the number of individual test strips, not the number of boxes).

(5) The medical supplies document "Pharmacy benefits: medical supplies and durable medical equipment products" is located on the ODM pharmacy website and includes five columns indicating supply item coverage and payments. The supplies in the document are billed through the pharmacy point of sale claims system using the national drug code (NDC) on the container from which the product was dispensed.

(a) Payment is the lesser of the submitted charge or the calculated allowable. The calculated allowable is the medicaid maximum payment.

(b) The calculated allowable is the medicaid maximum payment 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.

(C) 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 provider should bill through the pharmacy point of sale claims system using the NDC on the container from which the product was dispensed.

(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.

(D) Preferred medical supplies.

(1) Selected products from the medical supply categories included in the appendix of this rule are designated as preferred brands, as specified on the ODM website at https://pharmacy.medicaid.ohio.gov.

(2) Products that are not designated as preferred supplies require prior authorization.

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

(b) The prescriber should document medical necessity for the non-preferred brand and provide the reason why preferred brand cannot be used.

(c) When a request for prior authorization is denied, the recipient is informed in writing of the denial as well as informed of the right to appeal the denial.

Last updated February 16, 2024 at 8:11 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5162.03, 5164.02, 5164.70
Five Year Review Date: 2/16/2029
Prior Effective Dates: 10/1/2011
Rule 5160-9-03 | Pharmacy services: covered drugs and associated limitations.
 

(A) Covered prescribed drugs

Drugs covered by the Ohio department of medicaid (ODM) pharmacy program, or a managed care entity 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 recipient for use in the recipient'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 (November 19, 2021) that are not non-covered drugs as described in paragraph (B) of this rule.

(2) Over-the-counter (OTC) drugs listed on the "OH PBM OTC List" located on the ODM pharmacy website at https://pharmacy.medicaid.ohio.gov. The list is updated regularly and is recorded with the effective date included in each new version.

(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 website at https://pharmacy.medicaid.ohio.gov.

(4) Vaccines, inoculations, and immunizations, other than influenza and coronavirus vaccines, are covered under fee-for-service by the ODM pharmacy program only for residents of a NF or ICF/IID; otherwise these services should be billed as physician services in accordance with Chapter 5160-4 of the Administrative Code. Influenza and coronavirus vaccines may be billed by the pharmacy for a recipient who is not a resident of a NF or ICF/IID if the vaccine will be administered at the pharmacy, or for a recipient 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) Drug efficacy study implementation (DESI) drugs or drugs that are 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 a recipient who is eligible for medicare.

(6) Over-the-counter drugs that are not listed on the "OH PBM OTC List" located on the ODM pharmacy program website.

(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 website at https://pharmacy.medicaid.ohio.gov. This list indicates the drugs for which co-payments are necessary 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 are exempted from prior authorization if the pharmacy claim indicates that the prescription meets the criteria listed in section 5167.12 of the Revised Code.

(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)(5) 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 is 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)(5) 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 recipients 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. A pharmacist may also request prior authorization for a recipient resident in long term care.

(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 a recipient 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 recipient is informed in writing of the denial and the right to a state hearing.

(E) Compounded drugs

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

(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) Select chronic maintenance medications and select durable medical equipment (DME) products covered under the pharmacy benefit are limited to a one-hundred-two-day supply.

(2) Maximum quantity limits

Maximum prescription quantities are listed on the ODM pharmacy program website 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 website and establish the highest equivalent dose of certain therapeutic classes 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 website and establish the maximum number of claims for drugs that are therapeutic duplicates that are paid within specified time limits.

(5) Claims submitted that exceed the limits described in paragraphs (F)(1) to (F)(4) of this rule are denied. Denials may be overridden by ODM or its designee in cases where medical necessity was 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 was utilized will be denied.

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

(2) If a new prescription was issued by the prescriber that requires increased dosing frequency, the existing prescription must be utilized until the days supply per cent threshold was 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, waste, 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, for not more than three total months during a twelve month period.

(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 recipient was switched to generic or brand.

(g) The recipient is in the custody of the public children's services agency (PCSA) or other Title IV-E agency.

(H) Selected pharmaceuticals, including injectable drugs, are not covered under the pharmacy program if they are administered by a healthcare provider as defined in rule 4123-6-01 of the Administrative Code other than in 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 recipient 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 followed all regulations for a prescription pick-up station required by the Ohio state board of pharmacy. The pharmacy cannot dispense the pharmaceutical directly to the recipient, caregiver, or recipient'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 a recipient 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.

Last updated February 16, 2024 at 8:11 AM

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: 2/16/2029
Prior Effective Dates: 7/8/1978, 1/20/1988 (Emer.), 1/19/1989, 1/20/1989 (Emer.), 8/3/1989, 11/11/1993, 3/22/1997, 7/1/1998, 7/1/1999, 5/1/2000, 3/19/2001, 4/1/2004, 10/15/2005, 1/1/2006, 3/20/2008, 7/1/2009, 7/1/2011, 11/1/2013
Rule 5160-9-04 | Pharmacy services: drug utilization review.
 

(A) Recipient profiles, prospective drug utilization review (DUR), and recipient counseling

(1) Recipient profiles, prospective DUR and recipient counseling must be performed for medicaid recipients by medicaid pharmacy providers in accordance with agency 4729 of the Administrative Code.

(2) Documentation and records required by - agency 4729 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 is 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 is 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, in compliance with 42 U.S.C. 1396r-8 (January 3, 2022), reviews and recommends 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 ( scientific, medical, and pharmaceutical publications in which original manuscripts are rejected or published after critical review by unbiased independent experts).

(3) Remedial strategies are 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 includes 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 is 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 is 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 are for two years, with the remaining appointments being for one year. Subsequent appointments are for two years in alignment with the state fiscal year. The ODM staff person is an ongoing member of the board.

(b) Vacancies are filled for the unexpired terms in the same manner as the original appointments.

(3) Duties

(a) The DUR board reviews and recommends criteria used in DUR.

(b) The DUR board recommends multiple levels of interventions for physicians and pharmacists targeted toward therapy problems or recipients identified during retrospective drug use reviews. Intervention programs include, in appropriate instances, at least:

(i) Written, oral, or electronic reminders containing recipient specified and/or drug specific information and suggested changes in prescribing or dispensing practices, communicated in a way to ensure the privacy of recipient 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 are 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 recipients. 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 are reported back to the DUR board. The DUR board reevaluates interventions after an appropriate period of time to determine if the intervention improved the quality of drug therapy, evaluates the success of the interventions, and recommends modifications as necessary.

(d) The DUR board develops an informational package on the nature of the drug utilization review program.

(e) The DUR board provides for active and ongoing educational outreach programs to educate practitioners on common therapy problems and quality improvement initiatives.

(f) The DUR board prepares 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 meets up to four times per year, 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 is open to any interested party.

(c) The ODM reimburses each board member, other than the ODM staff person, one hundred fifty dollars per meeting.

Last updated February 16, 2024 at 8:11 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5162.03, 5164.02, 5164.759
Five Year Review Date: 2/16/2029
Prior Effective Dates: 1/1/1993, 4/14/2005
Rule 5160-9-05 | Pharmacy services: payment for prescribed drugs.
 

(A) 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 (E) of this rule. For prescribed drugs that are subject to a co-payment, the amount paid by the Ohio department of medicaid (ODM) is decreased by the amount equal to the co-payment billed to the recipient in accordance with rules 5160-1-09 and 5160-9-09 of the Administrative Code.

(B) The ingredient cost portion of the calculated allowable is determined in accordance with the following criteria:

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

(2) For any drug purchased under the 340B program, the ingredient cost is the lesser of submitted ingredient cost or the 340B ceiling price. If the 340B ceiling price is not available, the ingredient cost is the lesser of the submitted ingredient cost or fifty per cent of wholesale acquisition cost (WAC) If WAC is not available, the ingredient cost is the lesser of submitted ingredient cost or Ohio average acquisition cost (OAAC).

(3) For a clotting factor, the ingredient cost is the lesser of submitted ingredient cost or 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 (B)(1) to (B)(3) of this rule the ingredient cost is the lesser of submitted ingredient cost or national average drug acquisition cost (NADAC). If the centers for medicare and medicaid services (CMS) has not published a NADAC for the ingredient for the date of service, the ingredient cost is the lesser of submitted ingredient cost, OAAC, or WAC.

(C) 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 is nineteen dollars thirty-five cents. The administration fee for a vaccine for COVID-19 equals the medicare rate.

(D) The professional dispensing fee (PDF) portion of the calculated allowable is determined in accordance with the following criteria:

(1) The PDF to a provider for dispensing a non-compounded drug is assigned on the total number of prescriptions filled by the provider during the provider's last completed fiscal year prior to completing the required cost of dispensing survey and reported on the survey. The PDF is assigned in accordance with the following criteria:

(a) PDF payment amounts for dates of service prior to January 1, 2024:

(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 who failed to submit a complete response to the required cost of dispensing fee survey for the previous reporting period, eight dollars and thirty cents.

(vi) For providers newly enrolled as medicaid providers as described in rule 5160-9-06 of the Administrative Code, the PDF is as follows:

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

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

(b) PDF payment amounts for dates of service on or after January 1, 2024:

(i) For providers reporting fewer than fifty thousand prescriptions, fifteen dollars and forty-seven cents.

(ii) For providers reporting between fifty thousand and seventy-four thousand nine hundred ninety-nine prescriptions, eleven dollars and forty 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 prescriptions or greater, eight dollars and thirty cents.

(v) For providers newly enrolled as medicaid providers as described in rule 5160-9-06 of the Administrative Code, the PDF is as follows:

(a) For a new provider located in Ohio, the provider is assigned a PDF of fifteen dollars and forty-seven cents.

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

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

(a) The PDF for claims for dispensing total parenteral nutrition (TPN) is 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) 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, is ten dollars per day's supply, 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 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.

(c) Compounded drugs that are not eligible for the TPN or sterile compound PDF will receive the PDF determined under paragraph (D) of this rule.

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

(4) Notwithstanding paragraph (D)(1) of this rule, prescribed drugs, other than compounded drugs, dispensed to recipients residing in long term care facilities (LTCFs) are limited to one PDF per patient, per equivalent product, per month . If multiple supplies of an equivalent product are dispensed within the same month, only the ingredient cost will be paid. Exceptions to the one PDF per recipient, per product rule are:

(a) The prescriber ordered a second round of medication for an acute condition within the month.

(b) The prescriber changed the dosage.

(c) The drug was compromised by accident, including but not limited to being contaminated or destroyed.

(E) Coordination of benefits.

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

(2) No payment will be made under this chapter for any drug that may be covered by medicare part D for an recipient who is eligible for coverage by medicare part D, regardless of whether the recipient is actually enrolled in a part D plan or the particular drug is covered by the recipient'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 February 16, 2024 at 8:11 AM

Supplemental Information

Authorized By: 5164.02
Amplifies: 5162.03, 5162.20, 5164.70, 5164.752, 5164.753
Five Year Review Date: 2/16/2029
Prior Effective Dates: 11/1/1986, 1/13/1989 (Emer.), 6/1/1989, 2/3/2000 (Emer.), 6/12/2003, 10/16/2003 (Emer.), 10/1/2010, 7/1/2011, 1/1/2016
Rule 5160-9-06 | Pharmacy services: billing and recordkeeping requirements.
 

(A) The pharmacy claims submitted 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 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 recipient's medical record and given by medical staff directly to the pharmacy. The prescription is considered tamper resistant if the recipient 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 recipient is retroactively eligible, and the recipient's original or refill prescription was filled during a period when the recipient 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 section 340B(a)(4) of the "Public Health Service Act," 42 U.S.C. 256b(a)(4) (as in effect as of January 7, 2011) are submitted with the provider's actual acquisition cost plus cost of dispensing, and use the codes described in billing instructions issued by ODM or its designee.

(E) Voids and reversals

(1) Return to stock

(a) When recipients fail to pick up their prescriptions, pharmacies must reverse the claim submitted to ODM as soon as possible and not later than fourteen days after preparation.

(b) When prescriptions were 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 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 should 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 recipient 's responsibility amount assigned by each payer.

(G) Medicare part B-covered services

Drugs covered by medicare part B for dually eligible recipients will first be billed by the provider to medicare. When appropriate, ODM pays 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 should not be billed in a pharmacy claim format and should 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 recipients are not covered by medicaid. Medicaid does not pay medicare cost sharing for medicare part D services.

(I) Provider types described in rule 5160-9-01 of the Administrative Code 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 submitting 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 rule 5160-9-05 of the Administrative Code.

(3) Newly-enrolled providers are assigned to the dispensing fee described in rule 5160-9-05 of the Administrative Code.

(a) If the provider received the new provider number due to a change in ownership, the department uses the number of prescriptions reported by the previous ownership to determine the PDF.

(b) In a situation other than a change of ownership, a provider is newly enrolled if the date of approval for an application to enroll as a provider, or the date of approval of a specialty pharmacy designation, is less than ninety days prior to the distribution of the most recently conducted cost of dispensing survey then 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.

Last updated February 16, 2024 at 8:12 AM

Supplemental Information

Authorized By: 5162.031, 5164.02
Amplifies: 5162.031, 5164.02, 5164.03, 5164.70
Five Year Review Date: 2/16/2029
Prior Effective Dates: 12/21/1977, 7/8/1978, 4/1/2008
Rule 5160-9-07 | Pharmacy services: drug coverage review process.
 

(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.

Last updated December 6, 2023 at 1:08 PM

Supplemental Information

Authorized By: 5160.34, 5164.02
Amplifies: 5160.34, 5162.03, 5164.754, 5164.755, 5164.7510
Five Year Review Date: 11/30/2028
Prior Effective Dates: 2/1/1988, 1/13/1989 (Emer.), 2/3/2000 (Emer.), 5/1/2000
Rule 5160-9-09 | Pharmacy services: co-payments.
 

(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 February 16, 2024 at 8:12 AM

Supplemental Information

Authorized By: 5162.20, 5164.02
Amplifies: 5162.03, 5162.20, 5164.02
Five Year Review Date: 2/16/2029
Prior Effective Dates: 1/1/2004, 1/1/2006, 6/12/2020 (Emer.)