Chapter 173-71 Best Rx Program

(A) The rules in Chapter 173-71 of the Administrative Code seek to implement the best Rx program. The rules of this chapter describe how an individual may apply for the program, how ODA shall process the enrollment, how a pharmacy may participate in the program, how a drug manufacturer may participate in the program, how the price of a drug is determined, how ODA shall process a claim, how to handle records and trade secrets related to the program, and how an entity with whom ODA enters into a contract to administer the program shall administer the program.

(B) As used in Chapter 173-71 of the Administrative Code:

(1) “Administrative fee” means the amount that a participant is charged as a fee to defray the administrative costs of the best Rx program, in accordance with section 173.832 of the Revised Code and as regulated by rule 173-71-07.2 of the Administrative Code.

(2) “Administration percentage” means the percentage of each manufacturer payment that is retained by ODA for use in paying the administrative costs of the best Rx program in accordance with section 173.833 of the Revised Code and as regulated by rule 173-71-05 of the Administrative Code. This is a cost that is not passed on to the participant by a participating pharmacy.

(3) “Administrator” means a person with whom ODA has entered into a contract under which the person serves as the administrator of the powers or duties regarding the best Rx program that are delegated to the person in the terms of the contract, in accordance with the requirements and limitations of division (B) of section 173.721 of the Revised Code and paragraph (B) of rule 173-71-01.1 of the Administrative Code.

(4) “Applicant” means a person who provides a signature on an application or a person who is included in a signed application that is submitted to ODA for a determination of eligibility for the best Rx program.

(5) “Best Rx” means “Ohio’s best Rx program” as established by section 173.72 of the Revised Code.

(6) “Best Rx program fund” means a fund created in accordance with section 173.85 of the Revised Code.

(7) “Children’s health insurance program” means the children’s health insurance program part I, part II, and part III established under sections 5101.50 to 5101.529 of the Revised Code.

(8) “Consulting pharmacy benefit manager” (“consulting PBM”) means the PBM selected by ODA under section 173.731 of the Revised Code for the purposes of providing drug-pricing verification services and manufacturer-payment verification services for the best Rx program.

(9) “Disability medical assistance program” means the program established under section 5115.10 of the Revised Code.

(10) “Drug mail-order system” means a pharmacy selected in accordance with section 173.78 of the Revised Code and rule 173-71-04 of the Administrative Code to be the sole pharmacy participating in the best Rx program to operate a system for the purpose of making drugs included in the best Rx program available to participants by mail. In accordance with division (B)(8) of section 173.79 of the Revised Code, “drug mail-order system” does not mean the delivery of drugs by mail by a participating pharmacy that is not operating in the same manner as the drug mail-order system.

(11) “Family” means a unit consisting of the total number of family members living in one household who are related by blood or by a marriage recognized by this state including a father/husband, a wife/mother, and a son, step-son, daughter, step-daughter, or other child for whom either the aforementioned father or mother have physical custody as defined in section 3127.01 of the Revised Code. This definition does not apply to paragraph (B)(5)(c) of rule 173-71-01.1 of the Administrative Code.

(12) “Identifying information” means information that identifies or could be used to identify a participant or an applicant of the best Rx program. “Identifying information” does not include aggregate information about participants and applicants that does not identify and could not be used to identify an individual participant or applicant of the best Rx program.

(13) “Income” for an individual means the sum of money received by an individual over a period of time and “income” for a family means the sum of money received by each individual in the family who is not a dependent child. “Income” is calculated by adding together the money received from each of the following sources:

(a) Payment received from employment or self-employment (excluding overtime, bonuses, and self-employment expenses);

(b) Earnings from interest in real or personal property; and,

(c) Any payment received as a result of an insurance benefit, a pension, or child support.

(14) “Manufacturer agreement” means an agreement between ODA and a participating drug manufacturer under which the manufacturer agrees to make manufacturer payments to ODA with respect to one or more of the manufacturer’s drugs when the one or more drugs are dispensed under the best Rx program in accordance with section 173.81 of the Revised Code and as regulated by rule 173-71-06 of the Administrative Code.

(15) “Manufacturer payment” means the amount determined by a manufacturer agreement that a participating drug manufacturer pays ODA when one or more drugs are dispensed under the best Rx program.

(16) “Medicaid dispensing fee” means the dispensing fee established under Chapter 5111. of the Revised Code.

(17) “Medicaid program” (“medicaid”) means the medical assistance program established under Chapter 5111. of the Revised Code.

(18) “Medical assistance program” includes medicaid, the children’s health insurance program, disability medical assistance, and the refugee medical assistance.

(19) “Medicare prescription drug program” (“Medicare Part D”) means a medicare prescription drug plan established by the “Medicare Prescription Drug Improvement Modernization Act of 2003” 117 Stat. 2071, 42 U.S.C. 1295w-101.

(20) “National drug code number” (“NDC”) means the number registered for a drug pursuant to the listing system established by the United States food and drug administration under the “Drug Listing Action of 1972.,” 86 Stat. 559, 21 U.S.C. 360, as amended.

(21) “ODA” means “the Ohio department of aging.”

(22) “Ombudsman” means the person employed by ODA to assist pharmacies with grievances regarding the best Rx program, in accordance with section 173.723 of the Revised Code.

(23) “Participant” means an individual of which ODA has determined is eligible to participate in the best Rx program and who possesses a valid best Rx card.

(24) “Participating drug manufacturer” (“manufacturer”) means a drug manufacturer participating in the best Rx program pursuant to a manufacturer agreement entered into under section 173.81 of the Revised Code.

(25) “Participating pharmacy” means a pharmacy that is participating in the best Rx program pursuant to an agreement entered into under section 173.79 of the Revised Code and rule 173-71-05 of the Administrative Code. “Participating pharmacy” has the same meaning as “participating terminal distributor of dangerous drugs” as used in sections 173.07 to 173.90 of the Revised Code. “Participating pharmacy” does not include the drug mail-order system established by section 173.78 of the Revised Code.

(26) “Pharmacy” means a “terminal distributor of dangerous drugs” and has the same meaning as in section 4729.01 of the Revised Code.

(27) “Pharmacy assistance program” (“PAP”) means a pharmaceutical discount, rebate, or other prescription drug assistance program operated or sponsored by a drug manufacturer.

(28) “Pharmacy benefit manager” (“PBM”) means a person, other than a pharmacy or a pharmacist, who acts as an administrator in connection with pharmacy benefits.

(29) “Political subdivision” has the same meaning as in section 9.23 of the Revised Code.

(30) “Prescription drugs” has the same meaning as “dangerous drugs” as defined in division (F) of section 4729.01 of the Revised Code.

(31) “Professional fee” means a fee that a participating pharmacy may charge a participant to cover activities associated with the dispensing of a drug pursuant to a participating pharmacy agreement entered into under section 173.79 of the Revised Code, pursuant to section 173.831 of the Revised Code, and pursuant to rule 173-71-07.1 of the Administrative Code.

(32) “Signature” means the written signature of an individual or a certification by an individual through an online or a telephonic process developed by ODA.

(33) “State agency” has the same meaning as in section 9.23 of the Revised Code.

(34) “Third-party payer” has the same meaning as in section 3901.38 of the Revised Code.

(35) “Trade secret” has the same meaning as in section 1333.61 of the Revised Code.

(36) “Transaction” means the act of business that occurs when a pharmacy dispenses a quantity of a drug to a participant and when “dispense” has the same meaning as in rule 4729-5-01 of the Administrative Code.

(37) “Usual and customary charge” means the amount a participating pharmacy or the drug mail-order system charges when a drug included in the best Rx program is purchased by an individual who does not receive a discounted price for the drug pursuant to any drug discount program, including the best Rx program or a PAP established by any person or government entity, and for whom no third-party payer or program funded in whole or part with state or federal funds is responsible for all or part of the cost of the drug that the participating pharmacy dispenses to the individual.

Replaces: 5101:13-1-01

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.71, 173.72, 173.90

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) Except as provided in paragraph (B) of this rule, ODA shall administer the best Rx program.

(B) ODA may enter into a contract with any person under which the person serves as the administrator of the best Rx program.

(1) If ODA chooses to enter into such a contract, before entering into the contract, ODA shall issue a request for proposals from persons seeking to be considered. ODA shall follow the process outlined by section 125.071 of the Revised Code for selecting one of the persons seeking to become the administrator.

(2) Subject to divisions (B)(5) and (B)(6) of section 173.721 of the Revised Code, ODA may delegate to the person awarded the contract any of ODA’s powers or duties specified in sections 173.71 to 173.91 of the Revised Code or any other provision of the Revised Code pertaining to the best Rx program. The terms of the contract shall specify the extent to which the powers or duties are delegated to the administrator. Accordingly, ODA shall include the following terms in the contract:

(a) To the extent delegated by ODA, the administrator shall determine the eligibility of any applicant to the best Rx program by reviewing that application upon submission of the application to the administrator in accordance with section 173.76 of the Revised Code and rule 173-71-02 of the Administrative Code:

(i) Whenever the administrator determines that an applicant is ineligible to participate in the best Rx program, the administrator shall provide the applicant with information authorized by ODA on how to apply again and how to contact the administrator for assistance; or,

(ii) Whenever the administrator determines that an applicant is eligible to participate in the best Rx program, the administrator shall distribute information from ODA along with the participant’s best Rx card. The administrator shall distribute information on topics including, but not limited to, the following:

(a) General program information, such as the benefits of best Rx, how to use the card, and how to submit notification changes in address or family composition;

(b) Information on participating terminal distributors; and,

(c) Information on how to contact the administrator for assistance.

(b) The administrator shall process every claim submitted by any participating pharmacy in accordance with rule 173-71-08 of the Administrative Code;

(c) The administrator shall process each payment made by a manufacturer under a manufacturer agreement entered into in accordance with rule 173-71-06 of the Administrative Code, including, but not limited to, the reimbursement of a participating pharmacy, the preparation of an invoice for a participating drug manufacturer, and reconciliation to assure accuracy;

(d) The administrator shall retain and safeguard all hard-copy or electronic records related to the best Rx program throughout the contract period and for no less than six years following the termination of the contract or until the resolution of any outstanding audit or investigation, whichever is later. If the administrator chooses to enter into a contract with another person to offer the drug mail-order system, the administrator shall include a term in the contract with the other person that requires the other person to retain and safeguard all hard-copy or electronic records related to the drug mail-order system throughout the contract period and for no less than six years following the termination of the contract or until the resolution of any outstanding audit or investigation, whichever is later;

(e) The administrator shall submit any report or information to ODA that is requested by ODA;

(f) The administrator shall produce any records related to the best Rx program when requested by ODA;

(g) The administrator shall agree to any audit by the auditor of state, ODA, or any person designated by ODA, including an audit requested by a participating drug manufacturer that is approved by ODA in accordance with section 173.82 of the Revised Code;

(h) The administrator shall maintain identifying information of participants, former participants, and applicants to the best Rx program in confidentiality in accordance with sections 173.90 and 173.91 of the Revised Code and rule 173-71-09 of the Administrative Code;

(i) The administrator shall provide information and assistance to any applicant to the best Rx program, to any participant of the best Rx program, and to any other interested party through multiples avenues, including, but not limited to, the operation of a toll-free telephone line;

(j) The administrator shall provide information and assistance to participating pharmacies, including the operation of a toll-free call center, twenty-four hours a day, seven days a week. This is not to be confused with the resolution of a grievance which is handled by the ombudsman;

(k) In accordance with division (B) of section 173.86 of the Revised Code, ODA shall use money in the best Rx administration fund to pay the administrative costs of the best Rx program associated with services delegated by ODA to the administrator. ODA shall base the payment to the administrator, in part, or in whole, on the volume of transactions processed in claims submitted to the administrator by participating pharmacies and the drug mail-order system;

(l) In accordance with division (B)(5) of section 173.721, the administrator shall either offer the drug mail-order system, or else, the administrator shall enter into a contract with another person to offer the drug mail-order system;

(m) The administrator shall not enter into a contract with another person to delegate any power or duty of the best Rx program, except that, in accordance with divisions (B)(5) and (B)(6)(a) of section 173.721 of the Revised Code, if ODA has taken the option to include a term in the contract with the administrator to allow the administrator to enter into a contract with another person to offer the drug mail-order system, in accordance with division (B)(6)(a) of section 173.721 of the Revised Code, the administrator may enter into a contract with another person to offer that service;

(n) The administrator shall not receive verification of drug-pricing information under section 173.742 of the Revised Code or verification of manufacturer-payment information under section 173.814 of the Revised Code from the consulting PBM;

(o) The administrator shall not request the consulting PBM to provide for an audit under section 173.752 of the Revised Code;

(p) The administrator shall not review or use any information contained in or pertaining to an audit provided for by the consulting PBM other than the audit’s findings of whether the consulting PBM provided valid information when providing drug-pricing verification services or manufacturer-payment verification services;

(q) The administrator shall not adopt rules;

(r) The administrator shall not employ a participating pharmacy ombudsman in accordance with division (B)(6)(f) of section 173.721 of the Revised Code;

(s) The administrator shall not charge a fee to any applicant or participant for the submission of applications, for the processing of applications, or for the best Rx card; and,

(t) The administrator shall not charge any participating pharmacy for the submission or processing of any claim.

(3) In exercising powers or performing duties delegated under the contract, the administrator is subject to the same provisions of sections 173.71 to 173.91 of the Revised Code or other provisions of the Revised Code that grant the powers or duties to ODA, to the same provisions of Chapter 173-7 of the Administrative Code, and to any limitations or restrictions that are applicable to or associated with those powers or duties.

(4) Wherever ODA is referred to in sections 173.71 to 173.91 of the Revised Code, in Chapter 173-7 of the Administrative Code, or in another provision of the Revised Code relative to a power or duty delegated to the administrator, both of the following apply:

(a) If ODA has delegated the power or duty in whole to the administrator through a contract entered into between ODA and the administrator, the reference to ODA is, instead, a reference to the administrator; and,

(b) If ODA retains any part of the power or duty that is delegated to the administrator, the reference to ODA is a reference to both ODA and the administrator.

(5) In the contract between ODA and the person seeking to become the administrator, ODA shall include a term that declares that the person is not eligible to be the administrator if being selected as the administrator would create a conflict of interest and that entering into the contract is a written declaration that there is no conflict of interest between ODA and the person seeking to become the administrator. As used in this paragraph, “conflict of interest” means any of the following:

(a) An instance when an employee of ODA involved in selecting the administrator has an ownership interest in the person seeking to become the administrator, unless the local prosecuting attorney and the Ohio ethics commission determines that, in this instance, there is no conflict of interest;

(b) An instance when an employee of ODA involved in selecting the administrator is employed by the person seeking to become the administrator, unless the local prosecuting attorney and the Ohio ethics commission determines that, in this instance, there is no conflict of interest. As used in this paragraph, “employee” means one who is receiving a payment from the person; or,

(c) An instance when an employee of ODA involved in selecting the administrator has an immediate family member has any ownership interests in the person seeking to become the administrator or, when an immediate family member is employed by the person seeking to become the administrator, unless the local prosecuting attorney and the Ohio ethics commission determines that, in this instance, there is no conflict of interest. As used in this paragraph, “immediate family member” means a spouse, parent, parent-in-law, sibling, sibling-in-law, child, child-in-law, grandparent, aunt, or uncle.

Replaces: pt 5101:13-1-06

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.721, 173.86

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) The Ohio’s best Rx program council (“the council”) shall consist of the members specified in section 173.871 of the Revised Code.

(B) Pursuant to section 173.87 of the Revised Code, the council shall advise ODA on the best Rx program. With the approval of a majority of the council’s appointed members, the council may initiate studies to determine whether there are more effective ways to administer the program, including ways to enhance the participation of pharmacies in the program and to increase the number of participants enrolled in the program, and provide ODA with suggestions for improvements.

(C) Under the authority of division (D) of section 173.01 of the Revised Code to plan, initiate, coordinate, and evaluate statewide programs, under the authority of division (C) of section 173.02 of the Revised Code to develop and strengthen services available for the aging in the state by coordinating existing services provided by state and private agencies (i.e., pharmacies), under the authority of division (H) of section 173.02 of the Revised Code to provide consultants to individuals providing services supported by ODA (i.e., the council), and under the authority of division (J) of section 173.02 of the Revised Code to recommend methods for improving the effectiveness of state services for elderly citizens, ODA may create a pharmacy advisory group to advise ODA and the council on ways to enhance the participation of pharmacies in the best Rx program. Although the pharmacy advisory group may advise ODA and the council without the approval of the council, it may not conduct a study at the request of ODA or the council without the approval of a majority of the council’s appointed members.

Effective: 11/09/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.01, 173.02, 173.87, 173.871

Only an individual who meets the following criteria is eligible to participate in the best Rx program:

(A) The individual is a resident of Ohio;

(B) The individual is one of the following:

(1) An individual who is sixty years of age or older, regardless of family income level and regardless of whether or not the individual has a disability;

(2) An individual who is fifty-nine years of age or younger, regardless of family income level, who has a disability as defined in section 173.06 of the Revised Code; or,

(3) An individual who is fifty-nine years of age or younger whose family income, as determined by section 173.76 of the Revised Code, does not exceed three hundred percent of the federal poverty guidelines, as revised annually by the United States department of health and human services in accordance with section 673(2) of the “Omnibus Budget Reconciliation Act of 1981,” 95 Stat. 511, 42 U.S.C. 9902, as amended;

(C) Except as provided by paragraph (E) of this rule, the individual shall not have coverage for outpatient drugs paid for in whole or in part by any of the following:

(1) A third-party payer, including an employer;

(2) Medicaid;

(3) Children’s health insurance program;

(4) The disability medical assistance program; or,

(5) Another health plan or pharmacy assistance program that uses state or federal funds to pay part or all of the cost of the individual’s outpatient drugs, with the exception of the golden buckeye card and any health benefit plan offered to the employees of state agencies and the eligible dependents of those employees.

(D) The individual shall not have had coverage for outpatient drugs paid for by any of the entities or programs specified in paragraph (C) of this rule during any of the four months preceding the month in which the application for the best Rx program is made, unless any of the following applies:

(1) The individual is sixty years of age or older;

(2) The third-party payer, including an employer, that paid for the coverage filed for bankruptcy under federal bankruptcy laws;

(3) The individual is no longer eligible for coverage provided through a retirement plan subject to protection under the “Employee Retirement Income Security Act of 1974,” 88 Stat. 832, 29 U.S.C. 1001, as amended;

(4) The individual is no longer eligible for the medicaid program, children’s health insurance program, or disability medical assistance program; or,

(5) The individual is either temporarily or permanently discharged from employment due to a business reorganization.

(E) An individual is not subject to paragraph (C) of this rule if the individual has coverage for outpatient drugs paid for in whole or in part by either of the following:

(1) The workers’ compensation program; or,

(2) A medicare prescription drug plan offered pursuant to the “Medicare Prescription Drug, Improvement, and Modernization Act of 2003,” 117 Stat. 2071, 42 U.S.C. 1395w-101, as amended, but only if all of the following are the case with respect to the particular drug being purchased through the best Rx program:

(a) The individual is responsible for the full cost of the drug;

(b) The drug is not subject to a rebate from the manufacturer under the individual’s medicare prescription drug plan; and,

(c) The manufacturer of the drug has agreed to the best Rx program’s inclusion of individuals who have coverage through a medicare prescription drug plan.

Replaces: pt 5101:13-1-02

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.76

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) In accordance with section 173.722 of the Revised Code, ODA shall undertake outreach efforts to publicize the best Rx program and maximize participation in the program, which, at a minimum, shall include making applications, instructions for completing applications, and instructions for submitting applications available to anyone who requests such information (whether by telephone, in writing, electronically, or otherwise) or to the general public by displaying such information in community locations and on the internet.

(B) In accordance with section 173.724 of the Revised Code, ODA may coordinate the best Rx program with either of the following:

(1) The golden buckeye card program established under section 173.06 of the Revised Code. In coordinating the programs, ODA may establish a card that serves as both a golden buckeye card provided under section 173.06 of the Revised Code and a best Rx program enrollment card issued under section 173.773 of the Revised Code. ODA may identify the card by including the names of both programs on the card or by selecting a combined name for inclusion on the card; or,

(2) Any health benefit plan offered to the employees of state agencies and the eligible dependents of those employees, for purposes of enhancing efficiency, reducing the cost of drugs, and maximizing the benefits of the best Rx program and the health benefit plan.

(C) An individual may submit an application for the best Rx program on behalf of himself/herself or his/her family (which is defined by paragraph (B)(11) of rule 173-71-01 of the Administrative Code), so long as each individual family member on the application meets the eligibility criteria in section 173.76 of the Revised Code and rule 173-71-02 of the Administrative Code.

(D) An individual may submit a written application to ODA by returning a paper form prescribed and supplied by ODA; or, the applicant may apply by telephone or through the internet, in accordance with section 173.77 of the Revised Code.

(E) When submitting an application for enrollment into the best Rx program, the applicant shall include the following information on the application:

(1) For an application for an individual, the name and date of birth of the applicant; or, for an application for a family, the name, date of birth, and relationship to the primary applicant specified in accordance with paragraph (C) of this rule of each family member applying for the program;

(2) For an application for an individual, the address and telephone number; or, for an application for a family, the address and telephone number of the primary applicant specified in accordance with paragraph (C) of this rule;

(3) For an application for an individual, the total annual income of the applicant for the immediately preceding calendar year or the income for the three months preceding the month of application; or, for an application for a family, the total annual income of the family for the immediately preceding calendar year or the income for the three months preceding the month of application;

(4) Attestation that the applicant or primary applicant meets the eligibility requirements outlined in section 173.76 of the Revised Code and rule 173-71-02 of the Administrative Code; and,

(5) For an application for an individual submitted by the individual, the signature of the applicant; for an application for an individual submitted on behalf of the individual by a guardian or custodian, a statement attesting to the authority of the guardian or custodian to act on the behalf of the applicant; or, for an application for a family, the signature of the primary applicant specified in accordance with paragraph (C) of this rule.

(F) On each application, ODA shall inform each applicant that knowingly making a false statement in an application is falsification under section 2921.13 of the Revised Code, a misdemeanor of the first degree. In the case of a paper application form, ODA shall provide the information by including on the form a statement printed in bold letters.

(G) ODA shall return each application that is incomplete. With the returned application, ODA shall notify the applicant in writing that the applicant or family applying for the best Rx program is currently determined ineligible for the best Rx program due to an incomplete application and that the applicant is welcome to begin the enrollment process once again by submitting a complete application to ODA.

(H) Upon receipt of the application, ODA shall determine whether or not the applicant meets the eligibility requirements established by section 173.76 of the Revised Code and send a written notification of the determination to the applicant (or, in the case of a family, to the primary applicant) within four working days after ODA received the application. For an applicant who is not sixty years of age or older and who does not have a permanent total disability, ODA shall determine whether or not the income of the individual (or of the family) qualifies for enrollment into the best Rx program by comparing the annual income or the average monthly income during the preceding three months to three hundred per cent of the federal poverty guidelines for a family with the same number of members as that of the individual applying for the program. For the purposes of this paragraph, the determination of family size is based upon the total number of members of a family, as defined in paragraph (B)(12) of rule 173-71-01 of the Administrative Code, regardless of whether or not each individual member is party to the application for the best Rx program. In the event that the federal poverty guidelines change, ODA shall make adjustments to the eligibility requirements for the best Rx program that take effect within sixty days after the revised federal poverty guidelines are published in the Federal Register.

(I) An applicant, or anyone acting on behalf of an applicant, may not appeal the determination made under section 173.772 of the Revised Code and paragraph (H) of this rule by the appeal provisions of Chapter 119., section 5101.35, or any other provision of the Revised Code.

(J) If ODA determines that an applicant is ineligible, the applicant may reapply for the best Rx program at any time.

(K) At the same time that ODA issues a best Rx program enrollment cards to a new participant or notifies an applicant of its determination or ineligibility, ODA shall provide the participant or applicant with written information about the medicaid program. The information shall include general eligibility requirements, application procedures, and benefits. The information shall also explain the ways in which the medicaid program’s drug benefits are better than the best Rx program.

(L) If ODA determines that an applicant is eligible, ODA shall issue a best Rx program enrollment card to or on behalf of the participant. One enrollment card may cover each member of a family determined eligible to participate; however, ODA may issue up to two duplicate cards to such a family.

(M) At the same time that ODA issues a best Rx program enrollment cards to a new participant, ODA shall provide the participant with the following written information:

(1) General information about the best Rx program, such as the benefits of the program, how to use the card, and how to submit notification changes in address or family composition;

(2) Information on participating pharmacies; and,

(3) Information about how to contact ODA for assistance.

(N) A participant may use a best Rx card at any participating pharmacy or through the drug mail-order system.

(O) In accordance with division (B) of section 173.773 of the Revised Code, each time a drug is purchased under the program, the entity dispensing the drug shall confirm whether the individual for whom the drug is dispensed is enrolled in the program. If the drug is being purchased from a participating pharmacy, and the individual’s enrollment card is available for presentation at the time of the purchase, the purchaser shall present the card to the participating pharmacy as confirmation of the individual’s enrollment in the program. If the drug is being purchased through the drug mail-order system and the individual’s program identification number is available, the purchaser shall present the identification number as confirmation of enrollment. Otherwise, the participating pharmacy or the drug mail-order system shall confirm the individual’s enrollment through ODA.

(P) Purchasing a drug under the program by using an enrollment card or any other method shall serve as an attestation by the participant for whom the drug is dispensed that the participant meets the eligibility requirements specified in division (A)(3) of section 173.76 of the Revised Code regarding not having coverage for outpatient drugs.

(Q) A participant shall notify ODA of a change in address. Upon such a notification, ODA shall confirm whether or not the new address is in Ohio and meets the eligibility criteria for the best Rx program. ODA shall also update its records and send a response in writing to the participant acknowledging the change of address and its effect upon the participant’s continued eligibility.

(R) A participant shall notify ODA of a change in family composition. Upon such a notification, ODA shall update its records and send a response in writing to the participant with a replacement card(s) with the updated list of names on the card(s).

(S) A participant shall notify ODA of a loss of a best Rx card(s). Upon such a notification, ODA shall issue a replacement card(s) within one working day of notification.

Replaces: pt 5101:13-1-02

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.722, 173.724, 173.77, 173.771, 173.772, 173.773

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) For purposes of making drugs included in the best Rx program available to any participant by mail, ODA shall include one drug mail-order system within the program.

(B) ODA shall not promote the purchase of drugs through the drug mail-order system by using information collected under the program regarding the drugs purchased by participants from participating pharmacies. In accordance with division (D)(2) of section 173.90 of the Revised Code, the drug mail-order system may solicit, disclose, receive, or use identifying information or knowingly permit the use of identifying information to the extent required or permitted by ODA, except that it may not promote the purchase of drugs through the drug mail-order system by using information collected under the program regarding the drugs purchased by participants from participating pharmacies.

(C) Annually, ODA shall establish a base price for each drug included in the best Rx program that is dispensed by the drug mail-order system by using one or more formulas designated under paragraph (C) of rule 173-71-07 of the Administrative Code. Whenever a drug is dispensed through the drug mail-order system, the drug mail-order system shall charge a participant the base price plus the administrative fee specified by rule 173-71-07.2 of the Administrative Code, so long as the total price of a given drug is not more than the amount that is charged for the same quantity of the same drug dispensed by a participating pharmacy. In accordance with division (A)(5) of section 173.75 of the Revised Code, the drug mail-order system may not charge a participant a professional fee.

(D) In accordance with division (B) of section 173.773 of the Revised Code, each time a drug is purchased through the drug mail-order system and the participant’s program identification number is available, the participant shall present the identification number as confirmation of enrollment. Otherwise, the drug mail-order system shall confirm the individual’s enrollment through ODA.

(E) The drug mail-order system shall submit a claim to ODA for every drug sold to a participant through the drug mail-order system pursuant to section 173.80 of the Revised Code and rule 173-71-08 of the Administrative Code.

(F) The drug mail-order system shall maintain and safeguard all hard-copy or electronic records related to the best Rx program throughout the period of its contract with the administrator and for no less than six years following the termination of the contract with the administrator or until the resolution of any outstanding audit or investigation, whichever is later.

(G) The drug mail-order system shall comply with requests for information from ODA.

(H) The drug mail-order system shall collect the administrative fee specified by rule 173-71-07.2 of the Administrative Code. If the amount of the program administrative fees collected exceeds the amount of manufacturer payments owed in any quarter, as determined by ODA, the drug mail-order system shall reimburse the best Rx program fund for the amount of overpayment or accept a reduction in the amount of future manufacturer payments.

Replaces: pt 5101:13-1-06

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.773, 173.78, 173.80, 173.832

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) Any pharmacy may enter into an agreement with ODA to participate in the best Rx program pursuant to section 173.79 of the Revised Code. In accordance with division (D)(35) of section 127.16 of the Revised Code, any pharmacy may enter into an agreement with ODA without undergoing a competitive selection process.

(B) Before entering into an agreement with a pharmacy, ODA shall provide the pharmacy with one of the following:

(1) A formula that allows the pharmacy to calculate the amount that a participating pharmacy shall charge a participant for each drug included in the best Rx program, in accordance with division (A)(1) or (A)(2) of section 173.75 of the Revised Code;

(2) A statistically valid sampling of drug prices that includes the amount that a participating pharmacy shall charge a participant in accordance with division (A)(1) or (A)(2) of section 173.75 of the Revised Code for not fewer than two brand name drugs and two generic drugs from each category of drugs included in the best Rx program; or,

(3) The current amount that a participating pharmacy shall charge a participant for each drug included in the best Rx program, in accordance with division (A)(1) or (A)(2) of section 173.75 of the Revised Code.

(C) An agreement entered into between ODA and a pharmacy shall do all of the following:

(1) Except as provided in paragraph (C)(3) of this rule, remain in effect for not less than one year;

(2) Specify the date that the agreement begins and the date that the agreement ends;

(3) Permit the participating pharmacy to terminate the agreement before the date the agreement would otherwise end as specified pursuant to paragraph (C)(2) of this rule by providing ODA notice of early termination at least thirty days before the effective date of the early termination;

(4) Require the participating pharmacy to make best Rx applications and program information available to customers;

(5) Each time a drug is purchased under the program, require the participating pharmacy to confirm whether the individual for whom the drug is dispensed is enrolled in the best Rx program, in accordance with division (B) of section 173.773 of the Revised Code. If the participant’s enrollment card is available for presentation at the time of the purchase, the participant shall present the card to the participating pharmacy as confirmation of the participant’s enrollment in the program. Otherwise, the participating pharmacy shall confirm the individual’s enrollment through the ODA;

(6) Require the participating pharmacy to offer general drug counseling to the participant for every drug dispensed to the participant in accordance with division (B)(4) of section 4729.01 of the Revised Code;

(7) Require that the participating pharmacy comply with section 173.75 of the Revised Code when charging for a drug purchased under the best Rx program;

(8) Permit the participating pharmacy to add to the amount to be charged under division (A)(1) or (A)(2) of section 173.75 of the Revised Code a professional fee in an amount established by rule 173-71-07.1 of the Administrative Code;

(9) Require the participating pharmacy to add to the amount to be charged under division (A)(1) or (A)(2) of section 173.75 of the Revised Code the administrative fee specified by rule 173-71-07.2 of the Administrative Code. If the amount of the program administrative fees collected exceeds the amount of manufacturer payments owed in any quarter, and as determined by ODA, the participating pharmacy shall reimburse the best Rx program fund for the amount of overpayment or accept a reduction in the amount of future manufacturer payments;

(10) Require the participating pharmacy to disclose to each participant the amount the participant saves under the program as determined in accordance with section 173.752 of the Revised Code;

(11) Require the participating pharmacy to submit a claim to ODA under section 173.80 of the Revised Code for each sale of a drug included in the best Rx program to a participant;

(12) Permit the participating pharmacy to deliver drugs to participants by mail, but not by using a drug mail-order system that operates in the same manner as the drug mail-order system included in the best Rx program pursuant to section 173.78 of the Revised Code;

(13) Require the participating pharmacy to maintain and safeguard all hard-copy or electronic records related to the best Rx program during the term of the agreement and for no less than six years following the termination of the agreement or until the resolution of any outstanding audit or investigation, whichever is later;

(14) Permit the participating pharmacy to solicit, disclose, receive, or use identifying information or knowingly permit the use of identifying information for the purpose of increasing participation by individuals in the best Rx program, in accordance with division (D)(1) of section 173.90 of the Revised Code; and,

(15) Require the participating pharmacy to comply with requests for information by ODA.

(D) In accordance with section 173.791 of the Revised Code, no program or network of health care providers shall prohibit the participation of a pharmacy in that program or network of health care providers on the basis that the pharmacy has not entered into a participating pharmacy agreement under section 173.79 of the Revised Code to participate in the best Rx program.

Replaces: pt 5101:13-1-05

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.773, 173.79, 173.791, 173.90

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) As used in this rule,

(1) “Grievance” means the expression of dissatisfaction with the best Rx program by a participating pharmacy.

(2) “Resolution” means the final decision of ODA and its communication to the participating pharmacy regarding a grievance.

(B) Pursuant to section 173.723 of the Revised Code, ODA shall employ an ombudsman to assist a pharmacy with a grievance regarding the best Rx program.

(C) A participating pharmacy may submit a grievance to the ombudsman in writing, by email, by telephone, or by facsimile.

(D) ODA shall inform each participating pharmacy of the following:

(1) How a participating pharmacy may contact the ombudsman; and,

(2) What information a participating pharmacy shall include in the submission of a grievance to increase the likelihood of a timely response and resolution to the grievance.

Replaces: pt 5101:13-1-05

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.723

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) For purposes of participating in the best Rx program, any drug manufacturer may enter into an agreement with ODA under which the drug manufacturer agrees to make manufacturer payments to ODA with respect to one or more of the manufacturer’s drugs when the one or more drugs are dispensed under the best Rx program. The terms of the manufacturer agreement shall comply with section 173.811 of the Revised Code and paragraph (B) of this rule.

(B) A manufacturer agreement shall include terms that do all of the following:

(1) Specify the time the agreement is to be in effect, which shall be not less than one year from the date the agreement is entered into;

(2) Specify which of the participating drug manufacturer’s drugs are included in the agreement;

(3) Permit ODA to remove a drug from the manufacturer agreement in the event of a dispute over the drug’s utilization;

(4) Permit the participating drug manufacturer to make additions to the list of drugs covered by the agreement;

(5) Require that the drug manufacturer specify a per unit amount that will be paid to ODA for each drug included in the agreement that is dispensed to a participant;

(6) Require that the per unit amount specified by the drug manufacturer be an amount that the manufacturer believes is greater than or comparable to the per unit amount generally payable by the manufacturer for the same drug when the drug is dispensed to an individual using the outpatient drug coverage included in a health benefit plan offered in this state or another state to public employees or retirees and the eligible dependents of those employees or retirees;

(7) Require the drug manufacturer to make payments in accordance with the amounts computed under division (A) of section 173.812 of the Revised Code and paragraph (C) of this rule;

(8) Require the drug manufacturer to make manufacturer payments to ODA on a quarterly basis and within thirty days after receipt of an invoice; or, if the amount of the manufacturer payment due for any given quarter is less than fifty dollars, require the drug manufacturer to make the manufacturer payment once the total manufacturer payments due have accrued to fifty dollars, but for no longer than twelve months. ODA may withhold submitting a quarterly invoice to the drug manufacturer to request a manufacturer payment if no payment is due; or, if the amount of the manufacturer payment due for any given quarter is less than fifty dollars, ODA may withhold submitting a quarterly invoice to the drug manufacturer until the total manufacturer payments due have accrued to fifty dollars, but for no longer than twelve months;

(9) Require that the manufacturer payments are accompanied by a detailed list identifying the drugs, affirming the manufacturer payments being paid, and identifying, with explanation, any manufacturer payments not being paid as invoiced; and,

(10) Permit the drug manufacturer to refer best Rx program applicants and participants to a PAP operated or sponsored by the manufacturer for any drug included in the manufacturer agreement, only so long as the drug manufacturer refers residents of this state to the best Rx program if they apply for the PAP and are found to be ineligible for the PAP.

(C) When a drug included in a manufacturer agreement is dispensed under the best Rx program, the manufacturer payment amount that applies to the transaction is established in accordance with the following:

(1) ODA shall compute the manufacturer payment amount by multiplying the per unit amount specified for the drug in the manufacturer agreement by the number of units dispensed;

(2) For purposes of determining the amount to charge a participant under section 173.75 of the Revised Code and the amount that ODA shall pay for a claim in accordance with section 173.801 of the Revised Code, the manufacturer payment amount is computed as follows:

(a) Multiply the per unit amount specified for the drug in the manufacturer agreement by the program administration percentage;

(b) Subtract the product determined under paragraph (C)(2)(a) of this rule from the per unit amount specified for the drug in the manufacturer agreement; and,

(c) Multiply the per unit amount resulting from the computation under paragraph (C)(2)(a) of this rule by the number of units dispensed.

(D) ODA shall update the manufacturer payment amounts or formulas calculated under this rule at least annually.

(E) In its negotiations with a drug manufacturer proposing to enter into a manufacturer agreement, ODA shall use the best information on manufacturer payments that is available to ODA, including information obtained from the verifications made under section 173.814 of the Revised Code by the consulting PBM. ODA shall use the information in an attempt to obtain manufacturer payments that maximize the benefits provided to participants.

(F) Annually, ODA shall select a sample of not more than ten of the drugs that were included in the manufacturer agreements in the immediately preceding year. ODA shall submit to the consulting PBM information that identifies the per unit amount of the manufacturer payments that applied to each of the drugs in the sample.

The consulting PBM shall review the submitted information. After the review, the consulting PBM shall provide information to ODA verifying whether any of the per unit payment amounts that applied to the selected drugs were more than two per cent lower than the per unit payment amounts negotiated by the consulting PBM for the same drugs in connection with health benefit plans that generally do not use formularies to restrict the outpatient drug coverage included in the plans. The consulting PBM shall specify which, if any, of the drugs in the sample were subject to the lower per unit payment amounts. An officer of the consulting PBM shall certify the information by signature before providing it to ODA.

(G) ODA shall seek from the centers for medicare and medicaid services of the United States department of health and human services written confirmation that manufacturer payments are exempt from the medicaid best price computation applicable under Title XIX of the “Social Security Act,” 79 Stat. 286 (1965), 42 U.S.C. 1396r-8, as amended.

Entering into a manufacturer agreement does not require a drug manufacturer to make a manufacturer payment that would establish the manufacturer’s medicaid best price for a drug.

(H) Pursuant to section 173.82 of the Revised Code, a drug manufacturer that enters into a manufacturer agreement may submit a request to ODA to audit claims submitted under section 173.80 of the Revised Code. On submission of a request that ODA considers reasonable, ODA shall permit the participating drug manufacturer to audit the claims.

(I) Once a year or, at the discretion of ODA, at more frequent intervals, ODA shall determine the amount of each manufacturer payment that ODA shall retain for use in paying the administrative costs of the best Rx program.

(1) ODA shall retain five per cent of each manufacturer payment as the administrative percentage.

(2) ODA shall pay the participating pharmacies ninety-five per cent of the manufacturer payments received from participating drug manufacturers.

(3) ODA shall deposit the administrative percentage that it retains into the best Rx program fund.

Replaces: pt 5101:13-1-06

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.81, 173.811, 173.812, 173.813, 173.814, 173.815, 173.82, 173.833

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) Any entity that provides services as a PBM relative to the outpatient drug coverage included in a health benefit plan offered to the employees or retirees of a state agency or political subdivision, and the eligible dependents of those employees or retirees, shall provide drug-pricing verification services under section 173.742 of the Revised Code and manufacturer-payment verification services under section 173.814 of the Revised Code, if the entity is selected under section 173.731 of the Revised Code by ODA to serve as the consulting PBM for purposes of providing the verification services.

(1) Both of the following shall apply to the entity selected to serve as the consulting PBM:

(a) The entity shall provide the drug-pricing verification services and manufacturer-payment verification services without charge, either to the best Rx program or to the state agency or political subdivision for which it provides services as a PBM; and,

(b) The entity shall provide the verification services for the entire year for which it is selected to serve as the consulting PBM, regardless of the duration or termination of its responsibility to the state agency or political subdivision for which it provides services as a PBM.

(2) If the entity selected to serve as the consulting PBM fails to provide the program with drug-pricing verification services or manufacturer-payment verification services, or fails to provide for an audit when requested to do so under section 173.732 of the Revised Code, ODA may ask the attorney general to bring an action for injunctive relief in any court of competent jurisdiction. On the filing of an appropriate petition in the court, the court shall conduct a hearing on the petition. If it is demonstrated in the proceedings that the PBM has failed to provide the verification services or has failed to provide for the audit, the court shall grant a temporary or permanent injunction enjoining the PBM from continuing to fail to provide the verification services or from continuing to fail to provide for the audit.

(3) Paragraph (A) of this rule does not impose any duty on the state agency or political subdivision for which an entity provides services as a PBM.

(B) Annually, ODA shall select a PBM from among the PBMs subject to section 173.73 of the Revised Code to serve as the consulting PBM for purposes of providing drug-pricing verification services under section 173.742 of the Revised Code and manufacturer-payment verification services under section 173.814 of the Revised Code.

(1) ODA shall select the PBM that ODA considers to be the most appropriate PBM to provide the verification services for the best Rx program. In making the selection, the ODA shall consider the PBM that provides services relative to the outpatient drug coverage included in the health benefit plan offered to the greatest number of employees or retirees of a state agency or political subdivision and the eligible dependents of those employees or retirees.

(2) ODA shall provide written notice to the PBM that it has been selected to serve as the consulting PBM. The notice shall specify the date on which the PBM is to begin serving as the consulting PBM for the ensuing year.

(3) Before the end of the one-year period during which a PBM is to serve as the consulting PBM, ODA shall make another selection in accordance with section 173.731 of the Revised Code. In making the selection, ODA may select the same PBM to serve as the consulting PBM or may select another PBM.

(C) To determine whether the consulting PBM has provided valid information when providing drug-pricing verification services under section 173.742 of the Revised Code or manufacturer-payment verification services under section 173.814 of the Revised Code, ODA may request that the consulting PBM provide for an audit of its relevant contracts with drug manufacturers and pharmacies.

In making audit requests under this paragraph, both of the following apply:

(1) ODA may request such an audit on a regular basis, but not more frequently than once every three years.

(2) ODA may request an audit at any time it has a reasonable basis to believe that the consulting PBM is not acting in good faith in providing drug-pricing verification services or manufacturer-payment verification services. ODA shall notify the consulting PBM of the request for an audit in a written document that is signed by the director of ODA. The notice may specify the basis for the belief that the consulting PBM is not acting in good faith. If the basis for the belief is not specified and the audit findings demonstrate that the consulting PBM acted in good faith, ODA shall pay the cost incurred by the consulting PBM in providing for the audit.

(D) ODA shall choose an auditor to perform the audit of the consulting PBM that is mutually satisfactory to ODA and the consulting PBM and that is independent of both ODA and the consulting PBM.

(E) If the findings of an audit of the consulting PBM demonstrate that the verification services provided by the consulting PBM did not result in valid information, ODA shall use the audit findings for purposes of confirming the validity of the one or more drug-pricing formulas designated under section 173.741 of the Revised Code and entering into manufacturer agreements.

(F) Annually, ODA shall establish a base price for each drug included in the best Rx program in accordance with section 173.74 of the Revised Code. In the case of drugs dispensed by a participating pharmacy, ODA shall establish the base price for each drug by using the one or more formulas designated under paragraph (G) of this rule. In the case of drugs dispensed by the drug mail-order system, ODA shall also establish the base price by using one or more formulas designated under paragraph (C) of this rule.

(G) Annually, the ODA shall designate one or more formulas for use in establishing under section 173.74 of the Revised Code the best Rx program’s base price for drugs dispensed by a participating pharmacy. Each formula shall include a drug-pricing discount component that is expressed as a percentage discount. The formula used for generic drugs may include the maximum allowable cost limits that apply to generic drugs under the medicaid program.

(H) In designating the one or more formulas, ODA shall use the best information on drug pricing that is available to ODA, including information obtained through the drug-pricing verification services provided under section 173.742 of the Revised Code by the consulting PBM. Based on the available information, at least annually, ODA shall modify one or more formulas as it considers appropriate to maximize the benefits provided to participants, in accordance with section 173.741 of the Revised Code. As used in this paragraph “best information” includes, but is not limited to, drug-pricing information obtained from an industry-recognized drug-pricing compendium that is updated at least weekly.

(I) For purposes of section 173.741 of the Revised Code, ODA shall obtain verification of drug-pricing information from the consulting PBM in accordance with the following procedures:

(1) For brand name drugs, excluding generic drugs marketed under brand names, ODA shall submit to the consulting PBM the formula ODA proposes to use to establish the program’s base price for brand name drugs during the year.

The consulting PBM shall review the formula submitted by ODA. In conducting the review, the consulting PBM shall compare the drug-pricing discount percentage included in ODA’s formula to the drug-pricing discount percentage included in the formula most commonly used by the consulting PBM to establish part of its payment rate for brand name drugs dispensed by pharmacies other than drug mail-order systems. If the formulas are not expressed in equivalent terms, the consulting PBM shall make all accommodations necessary to make the comparison of the discount percentages.

After conducting the review, the consulting PBM shall provide information to ODA verifying whether the discount percentage included in the ODA’s formula is more than two percentage points below the discount percentage included in the formula used by the consulting PBM. An officer of the consulting PBM shall certify the information by signature before providing it to ODA.

(2) For generic drugs, ODA shall identify the fifty generic drugs most frequently purchased by participants in the immediately preceding year from participating pharmacies but not the drug mail-order system. ODA shall submit to the consulting PBM the names of the fifty drugs, the number of prescriptions filled for each of the drugs, the formula used to compute the base price for the drugs during the year, and the weighted average base price for the drugs that resulted for the year.

The consulting PBM shall review the submitted information. In conducting the review, the consulting PBM shall compare ODA’s weighted average base price to the equivalent part of the consulting PBM’s weighted average payment rate for the same drugs when dispensed by pharmacies other than drug mail-order systems. For purposes of the comparison, ODA and the consulting PBM shall express the weighted average base price and payment rate in terms of a discount percentage that is taken from the drugs’ average wholesale price, as identified by a national drug price reporting service selected by ODA and the consulting PBM.

After conducting the review, the consulting PBM shall provide information to ODA verifying whether the discount percentage reflected in the ODA’s weighted average base price for the drugs is more than two percentage points below the equivalent part of the consulting PBM’s weighted average payment rate for the same drugs. An officer of the consulting PBM shall certify the information by signature before providing it to ODA.

Replaces: pt 5101:13-1-03

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.73, 173.731, 173.732, 173.74, 173.741, 173.742

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) As used in this rule, “medicaid dispensing fee” means the dispensing fee established under section 5111.071 of the Revised Code for the medicaid program.

(B) A participating pharmacy may charge each participant a professional fee pursuant to a participating pharmacy agreement.

(C) A participating pharmacy may charge a professional fee of no more than three dollars per transaction regardless of whether the medicaid dispensing fee for that drug is less than that amount.

Replaces: pt 5101:13-1-03

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.831

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) Each participating pharmacy and the drug mail-order system shall charge each participant an administrative fee of one dollar per transaction.

(B) ODA shall collect administrative fees from each participating pharmacy and the drug mail-order system. ODA may reduce the amount of administrative fees owed to ODA by a participating pharmacy or the drug mail-order system by an equal amount of manufacturer payments that ODA owes to the participating pharmacy or the drug mail-order system.

(C) ODA shall deposit the administrative fees that it collects into the best Rx program fund.

Replaces: pt 5101:13-1-03

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.832

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) Subject to paragraph (B) of this rule, the amount that a participating pharmacy may charge a participant for a quantity of a drug purchased under the program is established in accordance with all of the following:

(1) For a drug that is not included in a manufacturer agreement, the participating pharmacy shall charge the participant an amount that is computed according to the drug’s base price established under section 173.74 of the Revised Code.

(2) For a drug that is included in a manufacturer agreement, the participating pharmacy shall charge a participant an amount that is computed by subtracting from the base price of the drug (established under section 173.74 of the Revised Code) the amount of the manufacturer payment that applies to the transaction, as established under section 173.812 of the Revised Code.

(3) The participating pharmacy or the drug mail-order system shall charge a participant the administrative fee when a drug is dispensed by the participating pharmacy or the drug mail-order system.

(4) If the terms of a participating pharmacy agreement state that a participating pharmacy shall charge a participant a professional fee when a drug is dispensed by the participating pharmacy, the participating pharmacy shall charge a participant the amount of the professional fee pursuant to the agreement.

(5) If the drug is dispensed through the drug mail-order system, the drug mail-order system shall not charge the participant a professional fee.

(B) When a quantity of a drug is purchased by a participant, the participating pharmacy or the drug mail-order system dispensing the drug shall charge the lesser of the amount that applies to the transaction, as established in accordance with paragraph (A) of this rule, or the usual and customary charge that otherwise would apply to the transaction. When a drug is purchased at the usual and customary charge pursuant to division (B) of section 173.75 of the Revised Code, the transaction is not subject to sections 173.71 to 173.91 of the Revised Code as the purchase or dispensing of a drug under the program.

(C) ODA shall report the following to each participating pharmacy and the drug mail-order system in a manner enabling the participating pharmacy and the drug mail-order system to comply with section 173.75 of the Revised Code:

(1) For each drug included in the program, the amount that a participating pharmacy or the drug mail-order system may charge a participant under division (A)(1) or (A)(2) of section 173.75 of the Revised Code; and,

(2) The administrative fee specified by rule 173-71-07.2 of the Administrative Code that a participating pharmacy or the drug mail-order system shall charge a participant.

Replaces: pt 5101:13-1-03

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.75, 173.751

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) For each drug dispensed under the best Rx program, the participating pharmacy or the drug mail-order system shall submit a claim to ODA not later than thirty days after the drug is dispensed by using the designated, on-line, point-of-sale system.

(B) ODA shall inform the participating pharmacy or the drug mail-order system submitting the claim of the best Rx price as determined in accordance with rules 173-71-07 to 173-71-07.3 of the Administrative Code.

(C) Each claim shall specify all of the following:

(1) The prescription number of the participant’s prescription under which the drug was dispensed to the participant;

(2) The name and NDC of the drug dispensed to the participant;

(3) The number of units of the drug dispensed to the participant;

(4) The amount the participant was charged for the drug, including the administrative fee and any professional fee;

(5) The date the drug was dispensed to the participant;

(6) The best Rx identification number of the participant;

(7) The best Rx identification number of the participating pharmacy;

(8) The usual and customary charge of the participating pharmacy for the drug dispensed to the participant; and,

(9) Any other information determined necessary by ODA to make a determination on a claim in an accurate and timely manner.

(D) Subject to section 173.803 of the Revised Code, ODA shall make a payment under the best Rx program for each complete and timely claim submitted under section 173.80 of the Revised Code for a drug included in the program that is also included in a manufacturer agreement. ODA shall make the payment for a complete and timely claim by a date that is not later than two weeks after ODA receives the claim from the participating pharmacy or the drug mail-order system.

(E) Subject to paragraph (G) of this rule, ODA shall make a determination on the amount to pay for a claim by performing the following duties:

(1) ODA shall compute the manufacturer payment amount that applies to the transaction, based on quantity of the drug dispensed and the drug’s NDC, in accordance with the provisions of division (B) of section 173.812 of the Revised Code; and,

(2) ODA shall subtract from the amount computed under paragraph (D)(1) of this rule the administrative fee amount specified in rule 173-71-07.2 of the Administrative Code.

(F) ODA may combine the claims submitted by a participating pharmacy or the drug mail-order system to make aggregate payments to the participating pharmacy or the drug mail-order system, in accordance with division (C) of section 173.801 of the Revised Code.

(G) If the total of the amounts computed under paragraph (E) of this rule for any period for which payments are due is a negative number, the participating pharmacy or the drug mail-order system that submitted the claims has been overpaid for the claims. When there is an overpayment, ODA shall take one of the following options:

(1) ODA shall reduce future payments made under section 173.831 of the Revised Code to the participating pharmacy or the drug mail-order system; or,

(2) ODA shall collect an amount from the participating pharmacy or drug mail-order system that is sufficient to reimburse ODA for the overpayment.

(H) Any manufacturer payment shall include a detailed statement identifying each claim for which a payment is being remitted and the specific amount for each claim.

(I) ODA shall not charge a participating pharmacy or the drug mail-order system for the submission of a claim under section 173.80 of the Revised Code nor the processing of a claim under section 173.801 of the Revised Code.

(J) ODA may not make a payment under section 173.801 of the Revised Code for a claim submitted under section 173.80 of the Revised Code if any of the following are the case:

(1) The claim is submitted by either a pharmacy that is not a participating pharmacy or a drug mail-order system that is not the system included in the best Rx program pursuant to section 173.78 of the Revised Code;

(2) The claim is for a drug that is not included in the program;

(3) The claim is for a drug included in the program but the drug is dispensed to an individual who is not covered by a best Rx program enrollment card; or,

(4) A person or government entity has paid the participating pharmacy or the drug mail-order system through any other prescription drug coverage program or prescription drug discount program for dispensing the drug, unless the payment is reimbursement for redeeming a coupon or is an amount directly paid by a drug manufacturer to the participating pharmacy or the drug mail-order system for dispensing drugs to residents of a long-term care facility.

Replaces: pt 5101:13-1-05

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.80, 173.801, 173.802, 173.803

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)

(A) ODA shall compile both of the following lists regarding the best Rx program, which are public records for the purpose of section 149.43 of the Revised Code. ODA shall specifically make the lists available to physicians, participating pharmacies, and other health professionals:

(1) A list consisting of the name of each drug manufacturer that enters into a manufacturer agreement and the names of the drugs included in each manufacturer agreement. As part of the list, ODA may include aggregate information regarding the drugs selected under section 173.814 of the Revised Code that were verified under that section as having per unit manufacturer payment amounts that were not more than two per cent lower than the per unit payment amounts negotiated for the same drugs by the consulting PBM. The information shall not identify a specific drug and ODA shall only express the information as a percentage of the sample of drugs selected under section 173.814 of the Revised Code; and,

(2) A list consisting of the name of each participating pharmacy and the name of the drug mail-order system.

(B) Information transmitted by or to any of the following for any purpose related to the best Rx program is confidential to the extent required by federal and state law:

(1) Any drug manufacturer;

(2) Any pharmacy;

(3) ODA;

(4) The consulting PBM;

(5) Any best Rx program participant; and,

(6) Any other government entity or person.

(C) Except as provided by section 173.892 of the Revised Code and paragraph (E) of this rule, all of the following are trade secrets and are not public records for the purposes of section 149.43 of the Revised Code:

(1) The amounts determined under section 173.801 of the Revised Code for payment of claims submitted by participating pharmacies and the drug mail-order system;

(2) Information disclosed in a manufacturer agreement or in communications related to an agreement;

(3) Drug-pricing and manufacturer-payment information verified under sections 173.742 and 173.814 of the Revised Code by the consulting PBM;

(4) Information contained in or pertaining to an audit provided for by the consulting PBM under section 173.732 of the Revised Code; and,

(5) The elements of the computations made pursuant to sections 173.75, 173.801, and 173.812 of the Revised Code and any results of those computations that reveal or could be used to reveal the drug manufacturer payment amounts used to make the computations.

(D) Neither ODA nor the consulting PBM shall use, release, publish, or disclose the described in paragraph (C) of this rule in a form that reveals a specific drug or the identity of a drug manufacturer except as required for the implementation of sections 173.71 to 173.91 of the Revised Code.

(E) Sections 173.89 and 173.891 of the Revised Code and paragraphs (B), (C), and (D) of this rule shall not preclude ODA from disclosing information necessary for the implementation of sections 173.71 to 173.91 of the Revised Code, including the amount a participant is to be charged when the amount is disclosed under section 173.751 of the Revised Code to participating pharmacies or the drug mail-order system.

(F) No person or government entity shall sell, solicit, disclose, receive, or use identifying information or knowingly permit the use of identifying information, except as follows:

(1) ODA may solicit, disclose, receive, or use identifying information or knowingly permit the use of identifying information for a purpose directly connected to the administration of the best Rx program, including disclosing and knowingly permitting the use of identifying information included in a claim that a participating drug manufacturer audits pursuant to section 173.82 of the Revised Code, contacting the applicants or participants regarding participation in the program, and notifying applicants and participants regarding participating pharmacies and the drug mail-order system;

(2) ODA may solicit, disclose, receive, or use identifying information or knowingly permit the use of identifying information to the extent required by federal law;

(3) ODA may disclose identifying information to the applicant or participant who is the subject of that information or to the parent, spouse, guardian, or custodian of that applicant or participant;

(4) A participating pharmacy may solicit, disclose, receive, or use identifying information or knowingly permit the use of identifying information to the extent required or permitted by an agreement the distributor enters into under section 173.79 of the Revised Code;

(5) Subject to division (B) of section 173.78 of the Revised Code, the drug mail-order system may solicit, disclose, receive, or use identifying information or knowingly permit the use of identifying information to the extent required or permitted by ODA; and,

(6) A participating drug manufacturer may, for the purpose of auditing a claim pursuant to section 173.82 of the Revised Code, solicit, receive, and use identifying information included in the claim.

(G) Except as provided in paragraph (H) of this rule, ODA shall use and preserve records regarding the best Rx program. ODA shall use and preserve the records, regardless of whether ODA generated the records or received them from another government entity or any person.

(H) ODA shall destroy all records received under sections 173.742 and 173.814 of the Revised Code from the consulting PBM after the ODA has completed the purpose for which the information contained in the records was obtained.

Replaces: pt 5101:13-1-02, pt 5101:13-1-03, 5101:13-1-04

Effective: 10/04/2007

R.C. 119.032 review dates: 08/31/2011

Promulgated Under: 119.03

Statutory Authority: 173.02, 173.83

Rule Amplifies: 173.88, 173.89, 173.891, 173.892, 173.90, 173.91

Prior Effective Dates: 11/1/2004, 4/4/07 (Emer.), 7/5/07 (Emer.)