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

CABINET FOR HEALTH AND FAMILY SERVICES

Office of Inspector General

Division of Audits and Investigations

(Amendment)

902 KAR 55:110. 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

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 [~~Fraud, Waste and Abuse, Identification and Prevention~~], Office of [~~the~~] 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

(3) "Dispenser" is defined by KRS 218A.010(9).

(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;

(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 shall 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) 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 seven (7) [~~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 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.

(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) 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 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 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 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.

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. 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) "KASPER Reporting Form", July 2008;

(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.

SADIQA N. REYNOLDS, ESQ, Inspector General

JANIE MILLER, Secretary

APPROVED BY AGENCY: April 13, 2009

FILED WITH LRC: April 14, 2009 at 3 p.m.

A public hearing on this administrative regulation shall, if requested, be held on May 21, 2009 at 9 a.m. in the Health Services Auditorium, 275 East Main Street, Frankfort, Kentucky. Individuals interested in attending this hearing shall notify this agency in writing by May 14, 2009 five (5) working days prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be cancelled. This hearing is open to the public. Any person who attends will be given an opportunity to comment on this proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to attend the public hearing, you may submit written comments on the proposed administrative regulation. You may submit written comments regarding this proposed administrative regulation until close of business June 1, 2009. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to:

CONTACT PERSON: Jill Brown, Office of Legal Services, 275 East Main Street 5 W-B, Frankfort, Kentucky 40601, Phone: 502-564-7905, Fax: 502-564-7573.

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

Contact Person: Sadiqa N. Reynolds or Stephanie Brammer-Barnes, 502-564-2888

(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 Schedule II - V controlled substances to report to the Cabinet for Health and Family Services each medication dispensed, including the date, time, and person to whom the medication was dispensed. This administrative regulation implements the Hal Rodgers Prescription Drug Monitoring Program, which was established in 2001 with a $34 million federal appropriation.

(b) The necessity of this administrative regulation: This administrative regulation is necessary to implement the KASPER Program, and to qualify for federal funds under the Hal Rodgers Grant awarded by the U.S. Bureau of Justice Assistance.

(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 - V controlled substances dispensed in Kentucky. 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 will require dispensers to transmit data to the Cabinet no later than seven (7) days after dispensing a Schedule II, III, IV, or V controlled substance. Currently, this administrative regulation requires dispensers to transmit data to the Cabinet no later than eight (8) days after dispensing a Schedule II - V controlled substance.

(b) The necessity of the amendment to this administrative regulation: This amendment will assure consistency with the one (1) week reporting guideline established by the National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER).

(c) How the amendment conforms to the content of the authorizing statutes: This amendment conforms to the content of the authorizing statutes by assuring consistency with the one (1) week federal reporting guideline established by NASPER at 42 U.S.C. 280g-3(d)(1). NASPER received a $2 million appropriation in a Federal Omnibus Spending bill signed by President Obama on March 11, 2009. NASPER establishes a Department of Health and Human Services Act formula grant program for states to establish, implement, or improve a prescription monitoring program (PMP). To be eligible, states must have enacted laws or regulations to permit implementation of a PMP and the imposition of appropriate penalties for the unauthorized use and disclosure of PMP information. This Fiscal Year 2009 appropriation must be obligated by September 30, and must follow a Federal Register notice to solicit comments on minimum standards. To meet these deadlines, it is conceivable that States would need to be in a position to submit grant applications no later than early to mid-July. This regulatory amendment will make Kentucky’s PMP requirements consistent with the NASPER guideline established in 42 U.S.C. 280g-3(d)(1), thereby enhancing the Cabinet’s ability to potentially secure funding from NASPER after submission of a grant application which the cabinet anticipates submitting in July 2009. Any funding the cabinet receives from NASPER would be used to make improvements to the KASPER system.

(d) How the amendment will assist in the effective administration of the statutes: The amendment will assist in the effective administration of the statutes by assuring consistency with the one (1) week federal reporting guideline established by 42 U.S.C. 280g-3(d)(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 pharmacists and other practitioners in Kentucky who dispense Schedule II - V controlled substances. Approximately 1,300 pharmacies and 225 dispensing physicians and veterinarians report to 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: This amendment will require dispensers to transmit data to the Cabinet no later than seven (7) days after dispensing a Schedule II, III, IV, or V controlled substance.

(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 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 would assure consistency with the one (1) week federal reporting guideline established by 42 U.S.C. 280g-3(d)(1), thereby enhancing the cabinet’s ability to potentially secure funding from NASPER after submission of a grant application which the cabinet anticipates submitting in July 2009.

(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 this amendment.

(b) On a continuing basis: No additional costs are necessary to implement this amendment on a continuing basis.

(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: State general funds and federal grant money from the Hal Rodgers Prescription Drug Monitoring Program.

(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: This amended administrative regulation does 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. Does this administrative regulation relate to any program, service, or requirements of a state or local government (including cities, counties, fire departments, or school districts)? Yes

2. 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 pharmacists and dispensing physicians and veterinarians in Kentucky who dispense Schedule II - V controlled substances.

3. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. The state laws that authorize promulgation of this administrative regulation are KRS 218A.202, 218A.240, and 218A.250. Additionally, this regulatory amendment will make Kentucky’s prescription monitoring program (PMP) requirements consistent with the NASPER guidelines established in 42 U.S.C. 280g-3, thereby enhancing the Cabinet’s ability to potentially secure funding from NASPER after submission of a grant application which the Cabinet anticipates submitting in July 2009. Any funding the cabinet receives from NASPER would be used to make improvements to the KASPER system.

4. 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:

FEDERAL MANDATE ANALYSIS COMPARISON

1. Federal statute or regulation constituting the federal mandate. The National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER), 42 U.S.C. 208g-3, establishes a grant program for states to create prescription drug monitoring databases and enhance existing ones, similar to the Harold Rogers Prescription Monitoring grant program from which Kentucky receives funding, along with state general funds, to support the KASPER system.

The Harold Rogers grant program, housed in the Department of Justice, allows states to establish their own requirements with regard to Schedules monitored, information sharing, and accessibility/availability to the program data. Harold Rogers encourages the sharing of information and prescription data among states. Harold Rogers encourages the submission of data for prescriptions in Schedules II, III, IV & V. Eligibility for Harold Rogers grant funds has a very simple requirement: States applying for grants must have in place an enabling statute or regulation "that requires submission of controlled substance prescription data to a centralized database administered by an authorized state agency."

NASPER, housed within the Department of Health and Human Services (HHS), requires states to meet requirements in order to receive grant funding. NASPER requires states to collect data for prescriptions in Schedules II, III, and IV. Additionally, NASPER requires states to be capable of sharing information and prescription data among states.

Although Kentucky does not currently receive funding from NASPER, this regulatory amendment will make Kentucky’s prescription monitoring program requirements consistent with the NASPER guidelines established in 42 U.S.C. 280g-3, thereby enhancing the Cabinet’s ability to potentially secure funding from NASPER after submission of a grant application which the Cabinet anticipates submitting in July 2009. Any funding the Cabinet receives from NASPER would be used to make improvements to the KASPER system.

2. State compliance standards. This administrative regulation complies with KRS 218A.202, which 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.

3. Minimum or uniform standards contained in the federal mandate. The NASPER guideline established in 42 U.S.C. 280g-3(d)(1) provides that "The State shall require dispensers to report to such State each dispensing in the State of a controlled substance to an ultimate user not later than one (1) week after the date of such dispensing." Therefore this regulatory amendment shortens the reporting period from eight (8) to seven (7) days, making Kentucky’s prescription monitoring program requirements consistent with the one (1) week reporting guideline established in 42 U.S.C. 280g-3(d)(1).

4. Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate? This administrative regulation does not impose stricter requirements, or additional or different responsibilities or requirements, than those required by the 42 U.S.C. 280g-3.

5. Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements. No additional standards or responsibilities are imposed.