To amend sections 4729.75, 4729.77, 4729.79, 4729.83, 4729.84, and 5111.172 and to enact sections 4729.791, 4729.821, 4729.831, 4731.055, 5111.179, and 5111.1710 of the Revised Code regarding the State Board of Pharmacy's drug database and a program for certain Medicaid recipients found to have over used items or services.

Section 1. That sections 4729.75, 4729.77, 4729.79, 4729.83, 4729.84, and 5111.172 be amended and sections 4729.791, 4729.821, 4729.831, 4731.055, 5111.179, and 5111.1710 of the Revised Code be enacted to read as follows:

Sec. 4729.75. (A) The state board of pharmacy may establish and maintain a drug database. The board shall use the drug database to monitor the misuse and diversion of controlled substances, as defined in section 3719.01 of the Revised Code, and other dangerous drugs the board includes in the database pursuant to rules adopted under section 4729.83 of the Revised Code. In establishing and maintaining the database, the board shall electronically collect information pursuant to sections 4729.77 and 4729.78 of the Revised Code and shall disseminate information as authorized or required by sections section 4729.79 and as required by sections 4729.791 and 4729.80 of the Revised Code. The board's collection and dissemination of information shall be conducted in accordance with rules adopted under section 4729.83 of the Revised Code.

(B) A drug database established under this section shall include both of the following:

(1) A process that permits information to be immediately submitted to the database by those required by section 4729.77 of the Revised Code to submit information to the board;

(2) The capacity to provide those authorized to view information in the database immediate access to that information.

Sec. 4729.77. (A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each pharmacy licensed as a terminal distributor of dangerous drugs that dispenses drugs to patients in this state and is included in the types of pharmacies specified in rules adopted under section 4729.83 of the Revised Code shall submit to the board the following prescription information:

(1) Terminal distributor identification;

(2) Patient identification;

(3) Prescriber identification;

(4) Purchaser identification, including any unique identifier established in rules adopted by the board under division (B) of section 4729.83 of the Revised Code;

(5) Date prescription was issued by prescriber;

(5)(6) Date prescription was dispensed;

(6)(7) Indication of whether prescription dispensed is new or a refill;

(7)(8) Name, strength, and national drug code of the drug dispensed;

(8)(9) Quantity of drug dispensed;

(9)(10) Number of days' supply of drug dispensed;

(10)(11) Serial or prescription number assigned by the terminal distributor;

(11)(12) Source of payment for the prescription.

(B) The information shall be transmitted as specified by the board in rules adopted under section 4729.83 of the Revised Code.

(1) The information shall be submitted electronically in the format specified by the board, except that the board may grant a waiver allowing the distributor to submit the information in another format.

(2) The information shall be submitted in accordance with any time limits specified by the board, except that the board may grant an extension if either of the following occurs:

(a) The distributor suffers a mechanical or electronic failure, or cannot meet the deadline for other reasons beyond the distributor's control.

(b) The board is unable to receive electronic submissions.

(C) This section does not apply to a prescriber personally furnishing or administering dangerous drugs to the prescriber's patient.

(D) If, based on review of information in the database, a pharmacist at a pharmacy elects not to dispense a drug to a patient, the pharmacy shall submit to the board the information required by divisions (A)(1), (2), (3), and (5) of this section; the name, strength, national drug code, and quantity of the prescribed drug; and an indication that the drug was not dispensed.

Sec. 4729.79. (A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board may provide information from the database in accordance with the following:

(1) On receipt of a request from a designated representative of a government entity responsible for the licensure, regulation, or discipline of licensed health care professionals authorized to prescribe drugs, the board may provide to the representative information from the database relating to the professional who is the subject of an active investigation being conducted by the government entity.

(2) On receipt of a request from a federal officer, or a state or local officer of this or any other state, whose duties include enforcing laws relating to drugs, the board may provide to the officer information from the database relating to the person who is the subject of an active investigation being conducted by the officer's employing government entity.

(3) Pursuant to a subpoena issued by a grand jury, the board may provide to the grand jury information from the database relating to the person who is the subject of an investigation being conducted by the grand jury.

(4) On receipt of a request from a pharmacist or prescriber, the board may provide to the requestor information from the database relating to a current patient of the requestor, if the requestor certifies in a form specified by the board that it is for the purpose of providing medical or pharmaceutical treatment to the patient who is the subject of the request.

(5) On receipt of a request from an individual seeking the individual's own database information in accordance with the procedure established in rules adopted under section 4729.83 of the Revised Code, the board may provide to the individual the individual's own database information.

(5) On receipt of a request from a managed care organization that has entered into a data security agreement with the board required by section 5111.1710 of the Revised Code, the board may provide to the managed care organization information from the database relating to a medicaid recipient enrolled in the managed care organization.

(B) The state board of pharmacy shall maintain a record of each individual or entity that requests information from the database pursuant to this section. In accordance with rules adopted under section 4729.83 of the Revised Code, the board may use the records to document and report statistics and law enforcement outcomes.

The board may provide records of an individual's requests for database information to the following:

(1) A designated representative of a government entity that is responsible for the licensure, regulation, or discipline of licensed health care professionals authorized to prescribe drugs who is involved in an active investigation being conducted by the government entity of the individual who submitted the requests for database information;

(2) A federal officer, or a state or local officer of this or any other state, whose duties include enforcing laws relating to drugs and who is involved in an active investigation being conducted by the officer's employing government entity of the individual who submitted the requests for database information.

(C) Information contained in the database and any information obtained from it is not a public record. Information contained in the records of requests for information from the database is not a public record. Information that does not identify a person may be released in summary, statistical, or aggregate form.

(D) Nothing in this section requires a pharmacist or prescriber to obtain information about a patient from the database. A pharmacist or prescriber shall not be held liable in damages to any person in any civil action for injury, death, or loss to person or property on the basis that the pharmacist or prescriber did or did not seek or obtain information from the database.

Sec. 4729.791. (A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board shall grant access to the information in the database to each licensed health professional authorized to prescribe drugs and to each pharmacist practicing in this state. The board shall grant access to the database in a manner that enables each prescriber and pharmacist to use the database in accordance with division (B) of this section or with rules adopted by the state medical board under section 4731.055 of the Revised Code.

(B) Before a prescriber issues a prescription to a patient for a drug included in the database and before a pharmacist dispenses such a drug, the prescriber and pharmacist may review information in the database that pertains to the patient. At any other time, a prescriber or pharmacist may review information in the database pertaining to a patient for the purpose of providing medical treatment or pharmacist services to the patient.

(C) A prescriber or pharmacist shall not be held liable in damages to any person in a civil action for injury, death, or loss to person or property on the basis that the prescriber or pharmacist did or did not review information in the database pertaining to a patient.

(D) Except as provided in rules adopted under section 4731.055 of the Revised Code, nothing in this section requires a pharmacist or prescriber to obtain information about a patient from the database.

Sec. 4729.821. If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the department of health, the department of insurance, and the state board of pharmacy shall, to the extent existing eligible funds are available, cooperate to contribute sufficient funds to permit the board to develop and operate in the drug database the capacity to immediately update database information and allow immediate access by authorized users, as provided by section 4729.75 of the Revised Code. The departments and board shall seek funding sources to permit the board to develop and operate the drug database in that manner. In doing so, the departments and board may collaborate to apply for grants or seek federal funds that may be available for developing and operating the drug database.

The director of budget and management may transfer cash between funds of the department of health, the department of insurance, and the state board of pharmacy as necessary to achieve the objectives of this section.

Sec. 4729.83. For purposes of establishing and maintaining a drug database pursuant to section 4729.75 of the Revised Code, the state board of pharmacy shall adopt rules in accordance with Chapter 119. of the Revised Code to carry out and enforce sections 4729.75 to 4729.82 of the Revised Code. The rules shall specify all of the following:

(A) A means of identifying each patient, terminal distributor of dangerous drugs, and each purchase at wholesale of dangerous drugs about which information is entered into the drug database;

(B) A means of identifying each purchaser of dangerous drugs, which may include assignment of a unique identifier for each purchaser;

(C) A means for a pharmacy to indicate that a pharmacist has elected not to dispense a drug to a patient;

(D) Requirements for the transmission of information from terminal distributors and wholesale distributors of dangerous drugs for purposes of the database;

(C)(E) An electronic format for the submission of information from terminal distributors and wholesale distributors of dangerous drugs;

(D)(F) A procedure whereby a terminal distributor or a wholesale distributor of dangerous drugs unable to submit information electronically may obtain a waiver to submit information in another format;

(E)(G) A procedure whereby the board may grant a request from a law enforcement agency or a government entity responsible for the licensure, regulation, or discipline of licensed health care professionals authorized to prescribe drugs that information that has been stored for two years be retained when the information pertains to an open investigation being conducted by the agency or entity;

(F)(H) A procedure whereby a terminal or wholesale distributor may apply for an extension to the time by which information must be transmitted to the board;

(G)(I) A procedure whereby a person or government entity to which the board is authorized to provide information may submit a request to the board for the information and the board may verify the identity of the requestor;

(H)(J) A procedure whereby the board can use the database request records required by division (B) of section 4729.79 of the Revised Code to document and report statistics and law enforcement outcomes;

(I)(K) A procedure whereby an individual may request the individual's own database information and the board may verify the identity of the requestor;

(J)(L) A reasonable fee that the board may charge under section 4729.82 of the Revised Code for providing an individual with the individual's own database information pursuant to section 4729.79 of the Revised Code;

(K)(M) The specific dangerous drugs other than controlled substances that must be included in the database;

(L)(N) The types of pharmacies licensed as terminal distributors of dangerous drugs that are required to submit prescription information to the board pursuant to section 4729.77 of the Revised Code;

(O) The manner in which prescribers and pharmacists are to be granted access to the database for purposes of section 4729.791 of the Revised Code.

Sec. 4729.831. The state board of pharmacy shall adopt rules in accordance with Chapter 119. of the Revised Code specifying the terms of a data security agreement described in section 5111.1710 of the Revised Code. The rules shall comply with privacy and security regulations promulgated under the "Health Insurance Portability and Accountability Act of 1996," Pub. L. No. 104-191, as amended, as specified in 45 C.F.R. Parts 160 and 164, as amended.

Sec. 4729.84. (A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board shall present a biennial report to the standing committees of the house of representatives and the senate that are primarily responsible for considering health and human services issues. The initial report shall be presented not later than two years after the database is established.

(B) Each report presented under this section shall include all of the following:

(1) The cost to the state of establishing and maintaining the database;

(2) Information from terminal distributors of dangerous drugs, prescribers, and the board regarding the board's effectiveness in providing information from the database;

(3) The board's timeliness in transmitting information from the database;

(4) The total number of prescriptions for which drugs were not dispensed due to the election of a pharmacist as indicated by information provided to the board under division (D) of section 4729.77 of the Revised Code.

Sec. 4731.055. (A) As used in this section:

(1) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(2) "Drug database" means a database established by the state board of pharmacy pursuant to section 4729.75 of the Revised Code.

(3) "Physician" means an individual authorized under this chapter to practice medicine and surgery or osteopathic medicine and surgery.

(B) The state medical board shall adopt rules in accordance with Chapter 119. of the Revised Code that establish standards and procedures to be followed by physicians regarding review of patient information available through the drug database. The rules shall include at least one of the following:

(1) A provision under which a physician who prescribes to patients, in total, a quantity of dangerous drugs exceeding an amount specified by the board is required to submit patient information to the drug database and review patient information in it;

(2) A provision under which a physician who prescribes to an individual patient a supply of dangerous drugs exceeding an amount specified by the board is required to submit patient information in the drug database and review patient information in it.

(C) The rules adopted under this section shall not apply if the state board of pharmacy does not establish a drug database or discontinues operation of a drug database.

Sec. 5111.172.  (A) When contracting under section 5111.17 of the Revised Code with a managed care organization that is a health insuring corporation, the department of job and family services may require the health insuring corporation to provide coverage of prescription drugs for medicaid recipients enrolled in the health insuring corporation. In providing the required coverage, the health insuring corporation may, subject to the department's approval, use strategies for the management of drug utilization.

(B) As used in this division, "controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

If a health insuring corporation is required under this section to provide coverage of prescription drugs, the department shall permit the health insuring corporation to develop and implement a pharmacy utilization management program under which prior authorization through the program is established as a condition of obtaining a controlled substance pursuant to a prescription. The Any such program may include processes for requiring medicaid recipients at high risk for fraud or abuse involving controlled substances to have their prescriptions for controlled substances filled by a pharmacy, medical provider, or health care facility designated by shall be consistent with the program the health insuring corporation is required to implement under section 5111.179 of the Revised Code.

Sec. 5111.179. Not later than one year after the effective date of this section, each contract the department of job and family services enters into with a managed care organization under section 5111.17 of the Revised Code shall require the managed care organization to implement a program consistent with 42 U.S.C. 1396n(a)(2) and 42 C.F.R. 431.54(e) for medicaid recipients enrolled in the organization who are found to have utilized items or services under the medicaid program at a frequency or amount that is not medically necessary. The program shall include a component that educates medicaid recipients about proper utilization of items and services provided under the medicaid program.

Sec. 5111.1710. Not later than one year after the effective date of this section and if the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each contract the department of job and family services enters into with a managed care organization under section 5111.17 of the Revised Code shall require the managed care organization to enter into a data security agreement with the board governing the managed care organization's use of the database. The data security agreement shall contain terms specified by the board in rules adopted pursuant to section 4729.831 of the Revised Code.

Section 2. That existing sections 4729.75, 4729.77, 4729.79, 4729.83, 4729.84, and 5111.172 of the Revised Code are hereby repealed.