902 KAR 22:010. Kentucky Board of Family Health Care Providers.
RELATES TO: KRS 216.900-216.930
STATUTORY AUTHORITY: KRS 216.920
NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 216 mandates that the Kentucky Board of Family Health Care Providers promulgate administrative regulations necessary to implement their duties and responsibilities. The administrative regulation responds to provisions of KRS 216.920 which requires board approval of treatment protocols, drug formularies and quality assurance programs before an applicant can receive a network license and begin full operation.
Section 1. Approval of Protocols. (1) An applicant for a licensed network shall submit for approval to the Board of Family Health Care Providers at time of application their twenty (20) protocols to be used by the midlevel health care practitioners or may use twenty (20) protocols that the board has developed.
(2) Protocols submitted to the board shall be designed for use by the midlevel health care practitioner and shall include items as issued in KRS 216.910(2).
(3) Network protocols to be used by the midlevel health care practitioner shall be designed to ensure a basic treatment plan for maintenance of identified chronic conditions.
(4) Approval for protocols shall be based on the following:
(a) The conditions for which protocols are established shall be chronic.
(b) Chronic conditions are those conditions that have a prolonged course that do not resolve spontaneously, and for which a complete cure is rarely achieved even with long-term maintenance.
(c) The protocol shall contain clear and concise instructions of procedures necessary for assessment, maintenance, treatment of a chronic condition diagnosed by the staff M.D. in the network; to include but not limited to: definition, patient assessment, review of relevant lab findings, medication management, requirements for physician consultation and with strong emphasis on health education.
(d) The protocol shall be written in a manner that prevents the need for a diagnostic decision by the midlevel health care practitioner.
(e) The protocol shall contain a list of drugs from the approved drug formulary that the midlevel health care practitioner may reorder for each condition.
(f) Board approval of the protocols for each licensed network will limit the certified midlevel health care practitioner to only those submitted and approved or prescribed by the board.
(g) After initial protocol approval, the licensed network shall submit any changes or additions to the board for approval.
Section 2. Drug Formulary. (1) The network formulary shall contain at a minimum, a list of the names of the pharmaceuticals approved for the use by the network and will include information regarding dosage, unit dispensing size, and contraindications.
(2) The network will clearly designate within the formulary, pharmaceuticals which can be reordered by the midlevel health care practitioner. The pharmaceuticals will be included in the treatment diagnosis protocols with clearly stated instructions of the midlevel health care practitioner's duties, responsibilities and limitations.
(3) The network will develop and provide an addendum to the network formulary which will include all pharmaceuticals with complete formulary information, which will be reordered, by the midlevel health care practitioner. This formulary will be correlated with the protocols handbook to be provided to each midlevel health care practitioner.
(4) After initial drug formulary approval, the licensed network shall submit any changes or additions to the board for approval.
Section 3. Quality Assurance. (1) The quality assurance program shall include specific mechanisms for reviewing and evaluating patient care stipulated by the twenty (20) chronic condition protocols which have been approved by the board for the use of the network and the midlevel health care practitioner. The mechanisms will be clearly designated to the protocols and clearly defined in the program.
(2) The Kentucky Board of Family Health Care Providers shall review for approval those parts of the networks quality assurance program that pertain to implementation of the protocols to be utilized by the midlevel health care practitioner.
(3) After initial quality assurance program approval, the licensed network shall submit any changes or additions to the board for approval.
Section 4. Process. (1) The Cabinet for Human Resources, Division of Licensing and Regulations shall inform the network applicant that their twenty (20) treatment protocols, the quality assurance program and drug formulary shall be submitted to the Kentucky Board of Family Health Care Providers for review and approval prior to issuance of a license to operate a network.
(2) The network applicant shall submit the twenty (20) treatment protocols, quality assurance program and drug formulary to: Kentucky Board of Family Health Care Providers, Cabinet for Human Resources, Department for Health Services, Division of Vital Records and Health Development, 275 East Main Street, Frankfort, Kentucky 40621.
(3) Upon receipt of the twenty (20) protocols, quality assurance program and drug formulary, a committee of the Kentucky Board of Family Health Care Providers shall review and make recommendation for approval/disapproval to the full board. If the recommendation of the committee is for disapproval, the committee shall define the deficiencies causing the recommended disapproval and allow ten (10) days for revision and resubmittal to the committee.
(4) The board shall take action at their quarterly meeting by approving or disapproving the applicants treatment protocols, drug formulary and quality assurance programs based on the recommendation of the review committee. The Department for Health Services shall document the actions of the board and forward a copy of the documentation to the Division of Licensing and Regulations. (18 Ky.R. 2501; Am. 2856; eff. 3-26-92.)