902 KAR 55:110. Monitoring system for prescription controlled substances.

902 KAR 55:110. Monitoring system for prescription controlled substances.

RELATES TO: KRS 218A.202

STATUTORY AUTHORITY: KRS 194A.050, 218A.202, 218A.250

NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.202 directs the Cabinet for Health and Family Services to establish an electronic system for monitoring Schedule II, III, IV, and V controlled substances that are dispensed in the Commonwealth by a practitioner or pharmacist or dispensed to an address within the Commonwealth by a pharmacy that has obtained authorization to operate from the Kentucky Board of Pharmacy. The purpose of this administrative regulation is to establish criteria for reporting prescription data, providing reports to authorized persons, and a waiver for a dispenser who does not have an automated recordkeeping system.

Section 1. Definitions. (1) "Branch" means the Drug Enforcement and Professional Practices Branch in the Division of Fraud, Waste and Abuse, Identification and Prevention, Office of the Inspector General, Cabinet for Health and Family Services.

(2) "Dispenser" is defined by KRS 218.010(9).

(3) "KASPER" means Kentucky All-Schedule Prescription Electronic Reporting System.

(4) "Patient identifier" means a patient's:

(a) Full name;

(b) Address, including zip code;

(d) Social Security number or an alternative identification number established pursuant to Section 5 of this administrative regulation.

(5) "Pharmacy Universal Claim Form" means a form that:

(a) Is in the format of the "Pharmacy Universal Claim Form" incorporated by reference in Section 6 of this administrative regulation; and

(b) Contains the information specified by Section 2(2) of this administrative regulation.

(6) "Report" means a compilation of data concerning a patient, dispenser, practitioner, or controlled substance.

Section 2. Data Reporting. (1) A dispenser shall report all dispensed controlled substances, except during the circumstances specified in KRS 218A.202(3)(a) and (b).

(2) A dispenser of a Schedule II, III, IV, or V controlled substance shall transmit or provide the following data to the cabinet or the cabinet’s agent:

(a) Patient identifier;

(b) National drug code of the drug dispensed;

(d) Date of dispensing;

(e) Estimated day's supply dispensed;

(f) Drug Enforcement Administration registration number of the prescriber;

(g) Serial number assigned by the dispenser; and

(h) The Drug Enforcement Administration registration number of the dispenser.

(3) The data identified in subsection (2) of this section shall be transmitted within eight (8) days of the date of dispensing unless the cabinet grants an extension.

(4)(a) An extension may be granted if:

1. The dispenser suffers a mechanical or electronic failure; or

2. The dispenser cannot meet the deadline established by subsection (3) of this section because of reasons beyond his control.

(b) A dispenser shall apply to the branch in writing for an extension listed in paragraph (a) of this subsection within twenty-four (24) hours of discovery of the circumstances necessitating the request or on the next date state offices are open for business, following the discovery. An application for an extension shall state the justification for the extension and the period of time for which the extension is necessary.

(5) An extension shall be granted to a dispenser if the cabinet or its agent is unable to receive electronic reports transmitted by the dispenser.

(6) Except as provided in subsection (9) of this section, the data shall be transmitted by:

(a) An electronic device compatible with the receiving device of the cabinet or the cabinet’s agent;

(b) Double sided, high density micro floppy disk;

(d) Secure File Transfer Protocol;

(e) https protocol;

(f) CD/DVD; or

(g) Secure Virtual Private Network connection.

(7) The data shall be transmitted in the format established by the "ASAP Telecommunications Format for Controlled Substances", American Society for Automation in Pharmacy, May 1995, or a comparable format approved by the branch.

(8) The cabinet shall provide a toll-free telephone number for transmitting electronic reports by modem.

(9) A dispenser, who does not have an automated recordkeeping system capable of producing an electronic report in the format established by "ASAP Telecommunications Format for Controlled Substances", may be granted a waiver from the electronic reporting requirement if the dispenser:

(a) Makes a written request to the branch within twenty-four (24) hours of discovery and of the circumstances necessitating the request, or on the next date that state offices are open for business following the discovery;

(b) Agrees in writing to immediately begin reporting the data by submitting a completed "Pharmacy Universal Claim Form" or comparable document approved in writing by the branch.

Section 3. Compliance. A dispenser may presume that the patient identification information established in Section 5 of this administrative regulation and provided by the patient or the patient’s agent is correct.

Section 4. Request for Report. (1) A written or electronic request shall be filed with the cabinet prior to the release of a report, except for a subpoena issued by a grand jury or an appropriate court order issued by a court of competent jurisdiction.

(2) A request for a KASPER report shall be made electronically at "http://chfs.ky.gov/oig/kasper".

(3) A request for a KASPER report shall be made by written application on one (1) of the following forms:

(a) For law enforcement, on the "Request for Law Enforcement KASPER Report", Form DCB-15L;

(b) For judiciary, on the "Request for KASPER Report (Court)", Form DCB-15J; or

Section 5. Patient Identification Number. (1) A patient or the person obtaining the controlled substance on behalf of the patient shall disclose to the dispenser the patient's Social Security number for purposes of the dispenser's mandatory reporting to KASPER.

(2) If a patient does not have a Social Security number, the patient’s driver’s license number shall be disclosed.

(3) If a patient has not been assigned a Social Security number or a driver’s license number, the number 000-00-0000 shall be used.

(4) If a patient is a child who does not have a Social Security number or a driver's license number, the Social Security number, driver's license number, or the number "000-00-0000", as applicable, of the parent or guardian shall be used.

(5) If a patient is an animal, the owner’s Social Security number, driver's license number, or the number "000-00-0000", as applicable, shall be used.

Section 6. Incorporation by Reference. (1) The following material is incorporated by reference:

(a) "ASAP Telecommunications Format for Controlled Substances", American Society for Automation in Pharmacy, May, 1995;

(b) "Pharmacy Universal Claim Form";

(d) "Request for KASPER Report (Court)", Form DCB-15J, 5/06; and

(e) "Request for KASPER Report", Form DCB-15P, 5/06.

(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Drug Enforcement and Professional Practices Branch, Office of the Inspector General, Cabinet for Health and Family Services, 275 E. Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. and may be viewed online at http://chfs.ky.gov/oig/KASPER.htm. (25 Ky.R. 966; Am. 1367; eff. 12-16-98; 32 Ky.R. 1927; 33 Ky.R. 120; eff. 7-24-06.)