173-71-01 Introduction and definitions.

(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,

(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.)