GENERAL GOVERNMENT

Kentucky Board of Optometric Examiners

(Amendment)

 

      201 KAR 5:130. Controlled substances.

 

      RELATES TO: KRS 218A.205(3)

      STATUTORY AUTHORITY: KRS 218A.205(3)

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.205(3) requires the board to promulgate administrative regulations on: prescribing standards for controlled substances; a procedure to temporarily suspend, limit, or restrict a license if unrestricted practice poses a danger to the health, welfare, or safety of patients or the public; a procedure for the expedited review of complaints pertaining to controlled substances; and penalties for convictions of offenses related to controlled substances. This administrative regulation establishes the requirements relating to controlled substances in the practice of optometry.

 

      Section 1. Prescribing Standards. (1) A Kentucky licensed optometrist authorized to prescribe controlled substances for humans shall:

      (a) Have a current and valid DEA number;

      (b) Register with Kentucky All Schedule Prescription Electronic Reporting (KASPER);

      (c) Prescribe controlled substances only for the treatment or relief of pain for a condition of the eye and its appendages;

      (d) Prescribe only Schedule III, IV, or V controlled substances;(e) Prescribe controlled substances for a quantity therapeutically sufficient, up to seventy-two (72) hours;

      (f) Examine the patient face-to-face and in-person prior to prescribing a controlled substance;

      (g) Verify the fact that the patient that is prescribed a controlled substance is who the patient claims to be;

      (h) Establish a documented diagnosis through the use of accepted medical practices; and

      (i) Keep accurate, readily accessible medical records which shall include:

      1. History and eye examination;

      2. Diagnostic, therapeutic, and laboratory results;

      3. Evaluations and consultations;

      4. Treatment objectives;

      5. Discussions of risk, benefits, and limitations of treatments;

      6. Treatments;

      7. Medication including date, type, dosage, and quantity prescribed; and

      8. Instructions and agreements.

      (2) A Kentucky licensed optometrist authorized to prescribe controlled substances for humans shall not:

      (a) Dispense any controlled substances;

      (b) Write a prescription for a controlled substance that is refillable; and

      (c) Prescribe:

      1. With the intent or knowledge that a medication will be used, or is likely to be used, for other than a medicinal or an accepted therapeutic purpose; or

      2. With the intent to evade any law with respect to sale, use, or disposition of the medication.

 

      Section 2. Temporary Suspension, Limit, or Restriction of License. (1) The board may, without benefit of a hearing, temporarily suspend, limit, or restrict the license of an optometrist authorized to prescribe controlled substances if the board finds on the basis of reasonable evidence that the licensee has violated a statute or administrative regulation the board is empowered to enforce, and continued unrestricted practice by the licensee would constitute a danger to the health, welfare, or safety of the licensee’s patients or of the general public.

      (2) The temporary suspension, limit, or restriction of a license shall take effect upon receipt by the licensee of written notice, delivered by certified mail or in person, specifying the statute or administrative regulation violated. At the time the temporary suspension, limit, or restriction order issues, the board shall schedule a disciplinary hearing to be held in accordance with the provisions of KRS Chapter 13B within ten (10) days.

 

      Section 3. Complaints. (1) The board shall consider all written complaints and sufficient anonymous complaints pertaining to the improper, inappropriate, or illegal prescribing of controlled substances. An anonymous complaint shall be considered sufficient if it is accompanied by sufficient corroborating evidence as would allow the board to believe, based upon a totality of the circumstances, that a reasonable probability exists that the complaint is meritorious.

      (2) Upon receipt of a complaint pertaining to the improper, inappropriate, or illegal prescribing of controlled substances, the board shall:

      (a) Send a copy of the complaint to the Office of the Attorney General, the Department of the Kentucky State Police, and the Cabinet for Health and Family Services within three (3) business days;

      (b) Commence an investigation within seven (7) business days of the complaint; and

      (c) Produce a charging decision within 120 days of the complaint, unless an extension for a definite time period is requested in writing by a law enforcement agency due to an ongoing criminal investigation.

 

      Section 4. Penalties. (1) Pursuant to the provisions of KRS 218A.205(3):

      (a) A licensee convicted of a felony offense related to [prescribing]a controlled substance shall, at a minimum, have a lifetime revocation on prescribing any and all controlled substances;

      (b) The board shall impose restrictions short of a permanent ban from prescribing controlled substances on a licensee convicted of a misdemeanor offense related to the prescribing of controlled substances. A licensee who has been convicted of any misdemeanor offense after July 20, 2012 relating to prescribing or dispensing controlled substances in any state shall have his or her authority to prescribe controlled substances suspended for at least three (3) months, and shall be further restricted as determined by the board; and

      (c) A licensee disciplined by a licensing board of another state related to the improper, inappropriate, or illegal prescribing of controlled substances shall, at a minimum, have the same disciplinary action imposed by the licensing board of the other state.

      (2) A licensee who is authorized to prescribe controlled substances shall be subject to discipline by the board if:

      (a) A licensee who is required to register for an account with KASPER fails to do so or does not maintain continuous registration during the licensee’s term of licensure; or

      (b) A licensee or applicant fails to report to the board, within thirty (30) days of the action:

      1. Any conviction involving controlled substances; or

      2. Disciplinary action taken by another licensure board involving controlled substances.

      (3) Pursuant to the provisions of KRS 218A.205(3)[(f)], the board shall submit all disciplinary actions to the National Practitioner Data Bank of the United States Department of Health and Human Services either directly or through a reporting agent.

 

WILLIAM REYNOLDS, O.D., Chair

      APPROVED BY AGENCY: December 14, 2017

      FILED WITH LRC: December 14, 2017 at 2 p.m.

      PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall be held on January 25, 2018, at 1 p.m., in the Board office, 2365 Harrodsburg Road, Suite A240, Lexington, Kentucky 40504. Individuals interested in attending this hearing shall notify the agency in writing by five (5) workdays 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 canceled. This hearing is open to the public. Any person who attends, will be given an opportunity to comment on the 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. Written comments shall be accepted until the end of day on January 31, 2018. Send written notification of intent to attend the public hearing or submit written comments on the proposed administrative regulation to:

      CONTACT PERSON: Connie Calvert, Kentucky Board of Optometric Examiners, 2365 Harrodsburg Road, Suite A240, Lexington, Kentucky 40504, phone 859-246-2744, fax 859-246-2746, email connie.calvert@ky.gov.

 

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

 

Contact person: Connie Calvert

      (1) Provide a brief summary of

      (a) What this administrative regulation does: This administrative regulation requires the board clarify the penalties permanent ban regarding controlled substances.

      (b) The necessity of this administrative regulation: This regulation is necessary to clarify a permanent ban from dispensing and prescribing controlled substances per KRS 218A.205.

      (c) How this administrative regulation conforms to the content of the authorizing statutes: The regulation is in conformity, as the authorizing statute requires that the board permanently ban any licensee from prescribing or dispensing controlled substances after a felony conviction related to controlled substances per KRS 218A.205.

      (d) How this administrative regulation will assist in the effective administration of the statutes: This administrative regulation will assist by establishing and clarifying a permanent ban from prescribing and dispensing controlled substances per KRS 218A.205.

      (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 only requires a licensee have any felony conviction related to a controlled substance versus an offense related to prescribing a controlled substance.

      (b) The necessity of the amendment to this administrative regulation: This amendment is necessary to comply with KRS 218A.205.

      (c) How the amendment conforms to the content of the authorizing statutes: KRS 218A.205 requires the board to establish a permanent ban based on any felony conviction regarding controlled substances.

      (d) How the amendment will assist in the effective administration of the statutes: This amendment provides the licensees with clear guidance regarding a permanent ban from prescribing and dispensing any controlled substance per KRS 218A.205.

      (3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: The Kentucky Board of Optometric Examiners currently has approximately 200 licensees.

      (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: There are no additional actions required.

      (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): There is no cost associated with the amendment.

      (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): The board is complaint with standards set forth in KRS 218A.205.

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

      (a) Initially: N/A

      (b) On a continuing basis: N/A

      (6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: N/A

      (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: An increase in fees or funding will not be required to implement the changes made by this regulation.

      (8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees: This administrative regulation does not establish and increase fees.

      (9) TIERING: Is tiering applied? Tiering was not used, all licensees are treated equally.

 

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? The Kentucky Board of Optometric Examiners

      2. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation: KRS 320.240, KRS 218A.205.

      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? N/A

      (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? N/A

      (c) How much will it cost to administer this program for the first year? N/A

      (d) How much will it cost to administer this program for subsequent years? N/A

      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: