STATEMENT OF EMERGENCY

902 KAR 55:110E

      This emergency administrative regulation is being promulgated to comply with 2012 (Extra. Sess.) Ky. Acts ch. 1 (2012 SS HB 1). Effective July 20, 2012, KRS 218A.202(18) requires that the Cabinet establish by administrative regulation an error resolution process allowing a patient to whom a report has been disclosed under KRS 218A.202(8) to request the correction of inaccurate information contained in the Kentucky All-Schedule Prescription Electronic Reporting (KASPER) system relating to that patient. Additionally, KRS 218A.202(15) permits the Cabinet to limit by administrative regulation the length of time that data remain in KASPER. This action must be taken on an emergency basis in accordance with KRS 13A.190(1)(a) to meet a deadline for the promulgation of an administrative regulation that is established by state law. Failure to enact this administrative regulation on an emergency basis in accordance with KRS 13A.190(1)(a) compromises the state’s ability to comply with the provisions of 2012 (Extra. Sess.) Ky. Acts ch. 1 on the date that the Act becomes effective as law. This emergency administrative regulation shall be replaced by an ordinary administrative regulation to be concurrently filed with the Regulations Compiler. The ordinary administrative regulation is identical to this emergency administrative regulation.

STEVEN L. BESHEAR, Governor

AUDREY TAYSE HAYNES, Secretary

CABINET FOR HEALTH AND FAMILY SERVICES

Office of Inspector General

Division of Audits and Investigations

(Emergency Amendment)

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

      RELATES TO: KRS 218A.010(9), 218A.202, 218A.240

      STATUTORY AUTHORITY: KRS 194A.050, 218A.202(1), 218A.250

      EFFECTIVE: July 20, 2012

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.202(1) 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. KRS 218A.250 requires the cabinet to promulgate administrative regulations pursuant to KRS Chapter 13A for carrying out the provisions of KRS Chapter 218A. 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 Audits and Investigations, Office of Inspector General, Cabinet for Health and Family Services.

      (2) "Cabinet personnel" means an individual who:

      (a)1. Is directly employed by the Cabinet for Health and Family Services; or

      2. Is employed by an agent or contractor of the cabinet;

      (b) Has undergone KASPER training; and

      (c) Has been approved to use the KASPER system.

      (3) "Dispenser" is defined by KRS 218A.010(9), and shall:

      (a) Include a dispenser who has a DEA (Drug Enforcement Administration) number or is a pharmacist who owns or is employed by a facility that operates a pharmacy which has a DEA number; and

      (b) Not include an individual licensed to practice veterinary medicine under KRS Chapter 321.

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

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

      (a) Full name;

      (b) Address, including zip code;

      (c) Date of birth; and

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

      (6)["KASPER Reporting Form" means a form that:

      (a) Is in the format of the "KASPER Reporting Form" incorporated by reference in Section 7 of this administrative regulation; and

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

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

      Section 2. Data Reporting. (1) A dispenser or a facility that has a DEA numbershall report all dispensed Schedule II, III, IV, or V controlled substances, except during the circumstances specified in KRS 218A.202(3)(a) and (b).

      (2) Reports pursuant to subsection (1) of this section shall not be required for:

      (a) A long-term care facility as defined by KRS 216.510(1);

      (b) An ambulance provider; or

      (c) A jail, correctional or detention facility, or a juvenile detention facility.

      (3)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;

      (c) Metric quantity of 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.

      (4)(a) Prior to July 1, 2013,[(3)] the data identified in subsection (3)[(2)] of this section shall be transmitted within seven (7) days of the date of dispensing unless the cabinet grants an extension.

      (b) Effective July 1, 2013, the data identified in subsection (3) of this section shall be transmitted no later than close of business on the business day immediately following the dispensing unless the cabinet grants an extension.

      (5)[(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 (4)[(3)] of this section because of reasons beyond his or her 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.

      (6)[(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.

      (7)[(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;

      (c) One-half (1/2) inch nine (9) track 1600 or 6250 BPI magnetic tape;

      (d)] Secure File Transfer Protocol;

      (c)[(e)] https protocol; or

      (d)[(f) CD/DVD; or

      (g)] Secure Virtual Private Network connection.

      (8)[(7)] The data shall be transmitted in the format established by the "ASAP Telecommunications Format for Controlled Substances", developed by theAmerican Society for Automation in Pharmacy, Version 4.1[May 1995], or a comparable format approved by the branch.

      (9)[(8)] 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", shall report the data identified in subsection (3) of this section using an Internet accessible web portal designated by the cabinet.[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; and

      (b) Agrees in writing to immediately begin reporting the data by submitting a completed "KASPER Reporting 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 patientreport shall be made electronically at www.chfs.ky.gov/KASPER[http://chfs.ky.gov/oig/kaspe r].

      (3) A request for a KASPER providerreport from a peace officer authorized to receive data under KRS 218A.202, or a designated representative of a board responsible for the licensure, regulation, or discipline of prescribing practitionersshall be made by written application on the "Request for KASPER Report (Law Enforcement and Licensure Boards)", Form DCB-15L.

      (4) A medical examiner engaged in a death investigation pursuant to KRS 72.026 may request a KASPER report on the decedent.[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

      (c) For pharmacy, on the "Request for KASPER Report", Form DCB-15P.]

      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 is an adult who does not have a Social Security number, the patient’s driver’s license number shall be disclosed.

      (3) If a patient is an adult who 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 in the Social Security number field.

      Section 6. KASPER Data and Trend Reports. Cabinet personnel shall be authorized access to the data obtained from the KASPER system and trend reports in accordance with KRS 218A.240(7)(a).

      Section 7. Data Retention. Data shall be maintained in KASPER for a period of two (2) years plus the current year prior to its transfer to the State Archives Center.

      Section 8. Error Resolution. (1) A patient to whom a report has been disclosed under KRS 218A.202(8) may request that information contained in KASPER be corrected if the patient believes that any information related to himself or herself is inaccurate. The patient or patient’s representative shall:

      (a) Contact the dispenser who reported the information required by Section 2(3) of this administrative regulation; and

      (b) Request that the dispenser correct the information.

      (2) If, upon receipt of a request from a patient or patient’s representative pursuant to subsection (1) of this section, the dispenser confirms that the information was reported in error, the dispenser shall:

      (a) Transmit corrected information to update the KASPER database; and

      (b) Notify the patient or patient’s representative that the corrected information has been transmitted.

      (3) If a dispenser maintains that information regarding the dispensing of a controlled substance was correctly reported to KASPER and the KASPER system generates a report with inaccurate information, the dispenser shall contact the Drug Enforcement and Professional Practices Branch (DEPPB) to identify the source of an error in the KASPER report, and the cabinet shall correct the information in the KASPER database.

      (4) Upon correction of information in the KASPER database pursuant to subsection (3) of this section, cabinet staff shall notify the patient or patient’s representative within five (5) working days of the correction.

      Section 9. Referrals to Licensing Boards. If the cabinet becomes aware that a prescriber or dispenser has failed to comply with the reporting requirements of KRS 218A.202 and this administrative regulation, the cabinet shall notify the licensing board or agency responsible for licensing the prescriber or dispenser.

      Section 10.Incorporation by Reference. (1) The following material is incorporated by reference:

      (a) "ASAP Telecommunications Format for Controlled Substances", American Society for Automation in Pharmacy, Version 4.1; and[May, 1995;]

      (b)["KASPER Reporting Form", July 2008;

      (c)] "Request for [Law Enforcement] KASPER Report (Law Enforcement and Licensure Boards)", Form DCB-15L, 12/10.[, 5/06;

      (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.[This material is also available online at http://chfs.ky.gov/oig/KASPER.htm.]

MARY REINLE BEGLEY, Inspector General

AUDREY TAYSE HAYNES, Secretary

      APPROVED BY AGENCY: July 13, 2012

      FILED WITH LRC: July 20, 2012 at 10 a.m.

      CONTACT PERSON: Mary Reinle Begley, Inspector General

Stephanie Brammer-Barnes, Internal Policy Analyst, Office of Inspector General, (502) 564-2888.

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

Contact Person: Mary Reinle Begley, Stephanie Brammer-Barnes

      (1) Provide a brief summary of:

      (a) What this administrative regulation does: This administrative regulation establishes the Kentucky All-Schedule Prescription Electronic Reporting (KASPER) system, which requires all dispensers of controlled substances to report to the Cabinet each medication dispensed, including the date, time, and person to whom a medication was dispensed.

      (b) The necessity of this administrative regulation: This administrative regulation is necessary to establish requirements related to the KASPER system.

      (c) How this administrative regulation conforms to the content of the authorizing statutes: This administrative regulation conforms to the content of KRS 218A.202 by establishing the KASPER system for monitoring Schedules II, III, IV, and V controlled substances that are dispensed in the Commonwealth. This administrative regulation is consistent with the policy mandate of KRS 218A.202 and assists in the identification of unauthorized use and dispensation of controlled substances.

      (d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This administrative regulation assists in the effective administration of the statutes by implementing the KASPER system and sets forth the mandatory reporting requirements for dispensers of controlled substances.

      (2) If this is an amendment to an existing administrative regulation, provide a brief summary of:

      (a) How the amendment will change this existing administrative regulation: This amendment clarifies that the following practitioners and facilities are not required to report dispensing data to KASPER: (1) individuals licensed to practice veterinarian medicine under KRS Chapter 321; (2) long-term care facilities; (3) ambulance providers; and (4) correctional facilities. Pursuant to 2012 (Extra. Sess.) Ky. Acts ch. 1 (2012 SS HB 1), this amendment establishes a one day reporting requirement which shall be effective July 1, 2013, establishes a data retention requirement, and provides for an error resolution process. This amendment further clarifies that a medical examiner engaged in a death investigation pursuant to KRS 72.026 may request a KASPER report on the decedent.

      (b) The necessity of the amendment to this administrative regulation: This amendment is necessary to comply with 2012 (Extra. Sess.) Ky. Acts ch. 1 (2012 SS HB 1).

      (c) How the amendment conforms to the content of the authorizing statutes: This amendment conforms to the content of the authorizing statutes by implementing KASPER system requirements for monitoring Schedules II, III, IV, and V controlled substances that are dispensed in the Commonwealth.

      (d) How the amendment will assist in the effective administration of the statutes: This amendment will assist in the effective administration of the statutes by demonstrating compliance with 2012 (Extra. Sess.) Ky. Acts ch. 1 (2012 SS HB 1).

      (3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: This administrative regulation impacts every practitioner and pharmacist in the Commonwealth required by state law to use the KASPER system.

      (4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:

      (a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment: Pursuant to KRS 218A.202(3), dispensers will be required to report data to KASPER within one (1) day of the dispensing. This requirement will be effective on July 1, 2013.

      (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): No additional costs will be incurred by practitioners or pharmacies in order to comply with this amendment.

      (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): Compliance with this amendment enhances the effectiveness of the KASPER system, and includes an error resolution process by which a patient may request that information contained in KASPER be corrected if the patient believes that such data is inaccurate.

      (5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:

      (a) Initially: No additional costs are necessary to implement the changes made by this amendment.

      (b) On a continuing basis: No additional costs are necessary to implement the changes made by this amendment.

      (6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: Federal funding under the Hal Rodgers Prescription Drug Monitoring Program and proceeds from the National Mortgage Settlement.

      (7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment: No increase in fees or funding will be necessary to implement this amended administrative regulation.

      (8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees: The amendment to this administrative regulation will not establish or increase any fees.

      (9) TIERING: Is tiering applied? Tiering is not applicable as compliance with this administrative regulation applies equally to all individuals or entities regulated by it.

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

      1. What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? This administrative regulation impacts every practitioner and pharmacist in the Commonwealth who dispenses controlled substances.

      2. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. KRS 218A.202, 218A.240, 218A.250      

      3. Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.

      (a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? There will be no additional revenue generated for state or local government for the first year that this administrative regulation is in effect.

      (b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? There will be no additional revenue generated for state or local government during subsequent years after this administrative regulation becomes effective.

      (c) How much will it cost to administer this program for the first year? No additional costs are necessary to administer this program during the first year.

      (d) How much will it cost to administer this program for subsequent years? No additional costs are necessary to administer this program for subsequent years.

      Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.

      Revenues (+/-):

      Expenditures (+/-):

      Other Explanation

The administrative regulations provided here are an unofficial posting of the Kentucky Administrative Regulations. Pursuant to KRS 61.874, it is unlawful to use any records available on the Kentucky web site for a commercial purpose without agreement with the Legislative Research Commission.