173-71-09 Records, trade secrets, and confidentiality.

(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.)