Title 201 | Chapter 020 | Regulation 057
SUPERSEDED
This document is no longer current.
PREVIOUS VERSION
The previous document that this document is based upon is available.
BOARDS AND COMMISSIONS
Board of Nursing
(Amended After Comments)
201 KAR 20:057.Scope and standards of practice of advanced practice registered nurses.
Section 1.
Definitions.(1)
"Collaboration" means the relationship between the advanced practice registered nurse and a physician in the provision of prescription medication, including both autonomous and cooperative decision-making, with the advanced practice registered nurse (APRN) and the physician contributing their respective expertise.(2)
"Collaborative Agreement for the Advanced Practice Registered Nurse's Prescriptive Authority for Controlled Substances" or "CAPA-CS" means the written document pursuant to KRS 314.042(11)(3)
"Collaborative Agreement for the Advanced Practice Registered Nurse's Prescriptive Authority for Nonscheduled Legend Drugs" or "CAPA-NS" means the written document pursuant to KRS 314.042(8).(4)
"Good standing" is defined by KRS 314.039.(5)
"Immediate family" means a spouse, parent, parent-in-law, stepparent, child, stepchild, son-in-law, daughter-in-law, sibling, stepsibling, brother-in-law, sister-in-law, grandparent, grandchild, spouse of grandparent or grandchild(6)
"KBML" means the Kentucky Board of Medical Licensure.(7)(5)
"PDMP"Section 2.
(1)
The practice of the APRN(2)
The following scope and standards of practice statements shall be adopted:(a)
AACN Scope and Standards for Acute Care Nurse Practitioner Practice;(b)
AACN Scope and Standards for Acute Care Clinical Nurse Specialist Practice;(c)
Neonatal Nursing: Scope and Standards of Practice;(d)
Nursing: Scope and Standards of Practice;(e)
Pediatric Nursing: Scope and Standards of Practice;(f)
Psychiatric- Mental Health Nursing: Scope and Standards of Practice;(g)
Scope of Practice for Nurse Practitioners;(h)
Standards of Practice for Nurse Practitioners;(i)
Scope of Nurse Anesthesia Practice;(j)
Standards for Nurse Anesthesia Practice;(k)
Standards for Office Based Anesthesia Practice;(l)
Standards for the Practice of Midwifery;(m)
Oncology Nursing Scope and Standards of Practice;(n)
The Women's Health Nurse Practitioner: Guidelines for Practice and Education;(o)
Definition of Midwifery and Scope of Practice of Certified Nurse-Midwives and Certified Midwives; and(p)
Standards for Professional Nursing Practice in the Care of Women and Newborns.Section 3.
CAPA-CS Practice Requirements for APRNs(1)
In the performance of advanced practice registered nursing, the APRN(2)
An APRN wishing to have a CAPA-CS in the first year of the APRN's licensure must be employed by a health care entity or provider. If the employing provider is an APRN, the employing APRN shall have been granted an exemption under Section 7 of this administrative regulation.(3)
During term of the CAPA-CS, the APRN and the collaborating physician shall meet,(a)
Both the APRN and the physician shall maintain a record of:1.
The meeting date;2.
A summary of discussions; and3.
Any recommendations made shall be made in writing.(b)
The record shall be maintained by both parties for a period of one (1) year past the expiration of the APRN CAPA-CS.(c)
The APRN's meeting records shall be subject to audit by the board and the physician's records shall be subject to audit by the KBML. The sole purpose of the audit shall be to document that the collaboration meetings have taken place to verify compliance with this section.(4)
In the first year of the CAPA-CS, the APRN and a physician shall meet at least quarterly; and(5)
In the ensuing three (3) years of the CAPA-CS, the APRN and the physician shall meet at least biannually.Section 4.
Advanced practice registered nursing shall include prescribing and administering medications, as well asSection 5.
Advanced practice registered nursing shall not preclude the practice by the APRNSection 6.
(1)
(a)
A CAPA-NS and a CAPA-CS shall include the:1.
Name;2.
Practice address;3.
Phone number;4.
License number of both the APRN5.
Population focus and area of practice of the APRN and each physician(b)
An APRN(c)
An APRN shall use the Standardized CAPA-CS Form.(2)
(a)
To notify the board of the existence of a CAPA-NS pursuant to KRS 314.042(8)(b), the APRN shall submit an online notification(b)
To notify the board that the requirements of KRS 314.042(9) have been met and that the APRN will be prescribing nonscheduled legend drugs without a CAPA-NS, the APRN shall submit an online notification(c)
To notify the board of the existence of a CAPA-CS pursuant to KRS 314.042(11)(b)(d)
To notify the board that the requirements of KRS 314.042(14) have been met and request that the APRN be exempt from prescribing scheduled legend drugs under a CAPA-CS, the APRN shall complete the request for APRN exemption from CAPA-CS prescriptive authority and pay the listed fee in administrative regulation 201 KAR 20:240, Section 3(1)(e). Each submitted request shall be subject to the fee, regardless of whether the board grants the exemption after making a determination under Section 7 of this administrative regulation.(e)
All notifications, rescissions, and exemption requests shall be submitted by the APRN to the board via the online KBN Nurse Portal at www.kbn.ky.gov, and shall include the information and documentation required by subsections (1) and (2) of this section.(f)
Upon request by the Board, the APRN shall furnish to the board a copy of the executed CAPA-NS Agreement or Standardized CAPA-CS Agreement Form.(3)
For purposes of the CAPA-NS and the CAPA-CS, in determining whether the APRN and the collaborating physician are qualified in the same or a similar specialty, the board shall consider the facts of each particular situation and the scope of the APRN's and the physician's actual practice.(4)
(a)
An APRN with controlled substance prescriptive authority(a)
Obtain a United States Drug Enforcement(b)
(5)
An APRN shall report any changes to a CAPA-NS or a CAPA-CS to the board within thirty (30) days.(6)
If an APRN's CAPA-NS or CAPA-CS ends unexpectedly for reasons outside the APRN's control such as being ended by the physician without notice, the physician's license becoming no longer valid in Kentucky, or the death of a physician, the APRN may continue to prescribe(7)
An APRN with a CAPA-NS or a CAPA-CS shall report a practice address to the board. A change to the practice address shall be reported to the board within thirty (30) days.(8)
All documents and information required to be reported to the board by this section shall be reported by uploading the document or information through the board's Web site, https://kbn.ky.govSection 7.
CAPA-CS Exemption Review Request.(1)
An APRN who wishes to request a CAPA-CS exemption pursuant to KRS 314.042(14) shall:(a)
Complete a CAPA-CS exemption review request the board's website as required in Section 6(8) of this administrative regulation;(b)
Submit the fee required by 201 KAR 20:240, Section 3(1)(e); and(c)
Comply with the requirements established in KRS 314.042(14) and this administrative regulation.(2)
Upon receipt of the CAPA-CS exemption review request, the board shall verify the following:(a)
The APRN has had four (4) years of controlled substance prescribing authority;(b)
The APRN's license is in good standing;(c)
The APRN has maintained a DEA registration and a current registration certificate is on file with the board;(d)
The APRN has maintained a PDMP registration and a current registration is on file with the board;(e)
That a current Notification of a CAPA-CS for the APRN is on record with the board; and(f)
The APRN has an active account with the PDMP.(3)
Upon receipt of the CAPA-CS exemption review request, the board shall:(a)
Perform a criminal background check for any unreported misdemeanor or felony convictions in Kentucky; and(b)
Perform a check of the coordinated licensure information system specified in KRS 314.475 for any unreported disciplinary actions in another state.(4)
The APRN submitting the request shall cooperate with supplemental requests for documentation before the board makes a determination that the APRN's license is in good standing pursuant to KRS 314.042(14).(5)
An APRN wishing to practice in Kentucky through licensure by endorsement may request an exemption under this section.(a)
An APRN wishing to practice in Kentucky through licensure by endorsement is exempt from the CAPA-CS requirement if the APRN:1.
Has met the prescribing requirements for controlled substances in a state that grants such prescribing authority to APRNs;2.
Has had authority to prescribe controlled substances for at least four (4) years; and3.
Has a license in good standing.(b)
An APRN wishing to practice in Kentucky through licensure by endorsement who has had the authority to prescribe controlled substances for less than four (4) years and wishes to continue to prescribe controlled substances shall enter into a CAPA-CS with a physician licensed in Kentucky and comply with the provisions of KRS 314.042(11), until the requirements of this section are met.(6)
If the board determines that the APRN is eligible for the exemption after a review and determination of the exemption request under this section, the board shall notify the APRN in writing that the CAPA-CS is no longer required. The board shall not require the APRN to maintain a CAPA-CS as a condition to prescribe controlled substances unless the board imposes such a requirement as part of an action instituted under KRS 314.091(1).(7)
If the board denies the exemption request, the denial shall be in writing and shall state the reasons for the denial. The requestor may request a hearing pursuant to KRS 13B within twenty (20) days of receiving written notification of the denial. If a hearing is requested and the order of the board is adverse to the advance practice registered nurse, the board may impose costs pursuant to administrative regulation 201 KAR 20:162, Section 7.(8)
The APRN nurse shall not prescribe controlled substances without a CAPA-CS until the board has completed its review and has notified the APRN in writing that the APRN is exempt from the CAPA-CS requirement.Section 8.Section 7.
Prescribing Medications without Prescriptive Authority. Prescribing nonscheduled legend drugs(1)
In the case of nonscheduled legend drugs, the(2)
In the case of controlled substances, the APRN was granted an CAPA-CS exemption by the Board under KRS 314.042(14)(e) prior to the date the medications were prescribed.Section 9.Section 8.
The board may make an unannounced visit to an Section 10.Section 9.
Prescribing Standards for Controlled Substances.(1)
(a)
This section shall apply to APRNs(b)
The APRN shall practice according to the applicable scope and standards of practice for the APRN's role and population focus. This section does not alter the prescribing limits established in KRS 314.011(8).(2)
Prior to the initial prescribing of a controlled substance to a patient, the APRN shall:(a)
Obtain the patient's medical history, including history of substance use, and conduct an examination of the patient and document the information in the patient's medical record. An APRN certified in psychiatric-mental health shall obtain a medical and psychiatric history, perform a mental health assessment, and document the information in the patient's medical record;(b)
Query(c)
Develop a written treatment plan stating the objectives of the treatment and further diagnostic examinations required; and(d)
Discuss with the patient, the patient's parent if the patient is an unemancipated minor child, or the patient's legal guardian or health care surrogate:1.
The risks and benefits of the use of controlled substances, including the risk of tolerance and drug dependence;2.
That the controlled substance shall be discontinued once the condition requiring its use has resolved; and3.
Document that the discussion occurred and obtain written consent for the treatment.(3)
The treatment plan shall include an exit strategy, if appropriate, including potential discontinuation of the use of controlled substances.(4)
For subsequent or continuing long-term prescriptions of a controlled substance for the same medical complaint, the APRN shall:(a)
Update the patient's medical history and document the information in the patient's medical record;(b)
Modify and document changes to the treatment plan as clinically appropriate; and(c)
Discuss the risks and benefits of any new controlled substances prescribed, including the risk of tolerance and drug dependence with the patient, the patient's parent if the patient is an unemancipated minor child, or the patient's legal guardian or health care surrogate.(5)
During the course of treatment, the APRN shall query(6)
These requirements may be satisfied by other licensed practitioners in a single group practice if:(a)
Each licensed practitioner involved has lawful access to the patient's medical record;(b)
Each licensed practitioner performing an action to meet these requirements is acting within the scope of practice of his or her profession; and(c)
There is adequate documentation in the patient's medical record reflecting the actions of each practitioner.(7)
If prescribing a controlled substance for the treatment of chronic, non-cancer pain, the APRN,(a)
Finds a drug screen clinically appropriate; or(b)
Believes that it is appropriate to determine whether(8)
If prescribing a controlled substance for the treatment of a mental health condition, the APRN shall meet the requirements of this section and KRS 314.011(8)(a) and (b).(9)
Prior to prescribing a controlled substance for a patient in the emergency department of a hospital that is not an emergency situation, the APRN shall:(a)
Obtain the patient's medical history, conduct an examination of the patient, and document the information in the patient's medical record. An APRN certified in psychiatric - mental health shall obtain a medical and psychiatric history, perform a mental health assessment, and document the information in the patient's medical record;(b)
Query(c)
Develop a written treatment plan stating the objectives of the treatment and further diagnostic examinations required; and(d)
Discuss the risks and benefits of the use of controlled substances with the patient, the patient's parent if the patient is an unemancipated minor child, the patient's legal guardian, or health care surrogate, including the risks of tolerance and drug dependence, and document that the discussion occurred and that the patient consented to that treatment.(10)
For each patient for whom an APRN prescribes a controlled substance, the APRN shall keep accurate, readily accessible, and complete medical records, which include:(a)
Medical history and physical or mental health examination;(b)
Diagnostic, therapeutic, and laboratory results;(c)
Evaluations and consultations;(d)
Treatment objectives;(e)
Discussion of risk, benefits, and limitations of treatments;(f)
Treatments;(g)
Medications, including date, type, dosage, and quantity prescribed;(h)
Instructions and agreements;(i)
Periodic reviews of the patient's file; and(j)
All(11)
The requirement to query(a)
An APRN prescribing or administering a controlled substance immediately prior to, during, or within the fourteen (14) days following an operative or invasive procedure or a delivery if the prescribing or administering is medically related to the operative or invasive procedure of the delivery and the medication usage does not extend beyond the fourteen (14) days;(b)
An APRN prescribing or administering a controlled substance necessary to treat a patient in an emergency situation; or(c)
An APRN prescribing a controlled substance:1.
For administration in a hospital or long-term-care facility with an institutional account, or an APRN in a hospital or facility without an institutional account, if the hospital, long-term-care facility, or licensee queries2.
As part of the patient's hospice or end-of-life treatment;3.
For the treatment of pain associated with cancer or with the treatment of cancer;4.
To assist a patient with submitting to a diagnostic test or procedure;5.
Within seven (7) days of an initial prescription pursuant to subsection (1) of this section if the prescriber:a.
Substitutes a controlled substance for the initial prescribing;b.
Cancels any refills for the initial prescription; andc.
Requires the patient to dispose of any remaining unconsumed medication;6.
Within ninety (90) days of an initial prescription pursuant to subsection (1) of this section if the prescribing is done by another licensee in the same practice or in an existing coverage arrangement, if done for the same patient for the same condition;7.
To a research subject enrolled in a research protocol approved by an institutional review board that has an active federal-wide assurance number from the United States Department of Health and Human Services, Office for Human Research Protections if the research involves single, double, or triple blind drug administration or is additionally covered by a certificate of confidentiality from the National Institutes of Health;8.
During the effective period of any disaster or situation with mass casualties that have a direct impact on the APRN's practice;9.
As part of the administering or ordering of controlled substances to prisoners in a state, county, or municipal correctional facility;10.
That is a Schedule IV controlled substance for no longer than three (3) days for an established patient to assist the patient in responding to the anxiety of a nonrecurring event; or11.
That is classified as a Schedule V controlled substance.(12)
In accordance with 21 C.F.R. 1306.12(b)(1)(iv) - (v), federal regulation 21 C.F.R. 1306.12(b) concerning the issuance of multiple prescriptions for Schedule II controlled substances shall not apply to APRNs in this state.(13)
No less than once every six (6) months, an APRN who holds a DEA Controlled Substance Registration Certificate shall review a reverse(a)
First contacting the reporting pharmacy;(b)
Contacting law enforcement if suspected fraudulent activity; or(c)
Contacting the Drug Enforcement Professional Practices Branch, Office of Inspector General, Cabinet for Health and Family Services.(14)
An APRN shall not issue a prescription for hydrocodone combination products for more than a three (3) day supply if the prescription is intended to treat pain as an acute medical condition, except if:(a)
The APRN, in his or her professional judgment, believes that more than a three (3) day supply of hydrocodone combination products is medically necessary to treat the patient's pain as an acute medical condition and the APRN adequately documents the acute medical condition and lack of alternative treatment options that justifies deviation from the three (3) day supply limit on the patient's medical records;(b)
The prescription for hydrocodone combination products is prescribed to treat chronic pain;(c)
The prescription for hydrocodone combination products is prescribed to treat pain associated with a valid cancer diagnosis;(d)
The prescription for hydrocodone combination products is prescribed to treat pain while the patient is receiving hospice or end-of-life treatment;(e)
The prescription for hydrocodone combination products is prescribed as part of a narcotic treatment program licensed by the Cabinet for Health and Family Services;(f)
The prescription for hydrocodone combination products is prescribed to treat pain following a major surgery, which is any operative or invasive procedure or a delivery, or the treatment of significant trauma; or(g)
Hydrocodone combination products are administered directly to an ultimate user in an inpatient setting.(15)
Prescriptions written for hydrocodone combination products pursuant to subsection (14)(a) through (g) of this section shall not exceed thirty (30) days without any refill.(16)
An APRN may prescribe electronically. Electronic prescription shall be as established in KRS 218A.171.(17)
For any prescription for a controlled substance, the prescribing APRN shall discuss with the patient the effect the patient's medical condition and medication may have on the patient's ability to safely operate a vehicle in any mode of transportation.Section 11.Section 10.
Immediate Family and Self-prescribing or Administering Medications.(1)
An APRN shall not self-prescribe or administer controlled substances.(2)
An APRN shall not prescribe or administer controlled substances to his or her immediate family except as established in subsections (3) and (4) of this section.(3)
An APRN may prescribe or administer controlled substances to an immediate family member:(a)
In an emergency situation;(b)
For a single episode of an acute illness through one (1) prescribed course of medication; or(c)
In an isolated setting, if no other qualified practitioner is available.(4)
(a)
An APRN who prescribes or administers controlled substances for an immediate family member pursuant to subsections (3)(a) or (b) of this section shall document all relevant information and notify the appropriate provider.(b)
An APRN who prescribes or administers controlled substances for an immediate family member pursuant to subsection (3)(c) of this section shall maintain a provider-practitioner relationship and appropriate patient records.Section 12.Section 11.
Incorporation by Reference.(1)
The following material is incorporate by reference:(a)
"AACN Scope and Standards for Acute Care Nurse Practitioner Practice", 2017 Edition, American Association of Critical-Care Nurses;(b)
"ACCN Scope and Standards for Acute Care Clinical Nurse Specialist Practice", 2014 Edition, American Association of Critical-Care Nurses;(c)
"Neonatal Nursing: Scope and Standards of Practice", 2013 Edition, American Nurses Association/ National Association of Neonatal Nurses;(d)
"Nursing: Scope and Standards of Practice", 2015 Edition, American Nurses Association;(e)
"Pediatric Nursing: Scope and Standards of Practice", 2015 Edition, American Nurses Association/ Society of Pediatric Nursing/ National Association of Pediatric Nurse Practitioners;(f)
"Psychiatric-Mental Health Nursing: Scope and Standards of Practice", 2014, American Nurses Association/ American Psychiatric Nursing Association;(g)
"Scope of Practice for Nurse Practitioners", 2019 Edition, American Association of Nurse Practitioners;(h)
"Standards of Practice for Nurse Practitioners", 2019 Edition, American Association of Nurse Practitioners;(i)
"Scope of Nurse Anesthesia Practice", 2013 Edition, American Association of Nurse Anesthetists;(j)
"Standards for Nurse Anesthesia Practice", 2019 Edition, American Association of Nurse Anesthetists;(k)
"Standards for Office Based Anesthesia Practice", 2019 Edition, American Association of Nurse Anesthetists;(l)
"Standards for the Practice of Midwifery", 2011 Edition, American College of Nurse Midwives;(m)
"Oncology Nursing Scope and Standards of Practice", 2019 Edition, Oncology Nursing Society;(n)
"The Women's Health Nurse Practitioner: Guidelines for Practice and Education", 2014 Edition, Association of Women's Health, Obstetric and Neonatal Nurses/Nurse Practitioners in Women's Health;(o)
"Definition of Midwifery and Scope of Practice of Certified Nurse-Midwives and Certified Midwives", 2012 Edition, American College of Nurse Midwives;(p)
"Standards for Professional Nursing Practice in the Care of Women and Newborns", 2019 Edition, Association of Women's Health, Obstetric and Neonatal Nurses;(q)
"Standardized CAPA-CS Agreement Form", _9/2023(r)
"(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Board of Nursing, 312 Whittington Parkway, Suite 300, Louisville, Kentucky 40222, Monday through Friday, 8 a.m. to 4:30 p.m. This material is also available on the board's Web site at https://kbn.ky.gov/General/Pages/Document-Library.aspxAUDRIA DENKER, President
APPROVED BY AGENCY: January 5, 2024
FILED WITH LRC: January 11, 2024 at 10:05 a.m.
CONTACT PERSON: Jeffrey R. Prather, General Counsel, Kentucky Board of Nursing, 312 Whittington Parkway, Suite 300, Louisville, Kentucky 40222, (502) 338-2851, Jeffrey.Prather@ky.gov. cky.gov/formservices/Nursing/PendReg.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Jeffrey Prather
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation sets standards for APRN practice.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary because of KRS 314.042.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation conforms to the content of the authorizing statutes by setting standards of practice.
(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 setting standards of practice.
(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:
The amendment clears up regulatory language to use "APRN"; adds definitions for "Good standing", "Immediate family" and "PDMP" (prescription drug monitoring program). It establishes regulatory standards for APRNs engaged in a CAPA-CS, including creation of a new CAPA-CS form. The amendments further provide for the regulatory process by which an APRN may request an exemption from the CAPA-CS requirement, in accordance with Senate Bill (SB) 94 (2023RS).
(b) The necessity of the amendment to this administrative regulation:
These regulation amendments were necessary due to SB 94, and the changes to KRS 314.042.
(c) How the amendment conforms to the content of the authorizing statutes:
By clearly stating requirements.
(d) How the amendment will assist in the effective administration of the statutes:
By clearly stating standards, procedures, and requirements.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
Kentucky APRNs, approximately 14,000 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:
APRNs who wish to be in a CAPA-CS will need to use the form incorporated by reference. If the wish to request an exemption, they must be in good standing, provide a DEA and a PDMP registration, and meet the 4-year prescribing requirement.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
No additional cost, other than the exemption request fee in 201 KAR 20:240, which is mandated by KRS 314.042(14)(b)(4),
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
They will be in compliance with the administrative regulation and KRS 314.042, and will be authorized to prescribe controlled substances.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
No additional cost.
(b) On a continuing basis:
No additional cost.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Agency funds.
(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 fees are increased; however, a fee of $50 has been proposed in 201 KAR 20:240, which is mandated by KRS 314.042(14)(b)(4), and currently in promulgation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This regulation does not establish a fee; however, see KRS 314.042(14)(b)(4), and 201 KAR 20:240.
(9) TIERING: Is tiering applied?
The changes will apply equally, there is no tiering.
FISCAL NOTE
(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?
Board of Nursing.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
Kentucky Revised Statutes KRS 218A.205(3)(a), (b), 314.131(1), 314.042, and 314.193.
(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?
None.
(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?
None.
(c) How much will it cost to administer this program for the first year?
No additional cost.
(d) How much will it cost to administer this program for subsequent years?
No additional cost.
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:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
None.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
None.
(c) How much will it cost the regulated entities for the first year?
None.
(d) How much will it cost the regulated entities for subsequent years?
None.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
Expenditures (+/-):
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This administrative regulation will not have a major economic impact.
BOARDS AND COMMISSIONS
Board of Nursing
(Amended After Comments)
201 KAR 20:057.Scope and standards of practice of advanced practice registered nurses.
Section 1.
Definitions.(1)
"Collaboration" means the relationship between the advanced practice registered nurse and a physician in the provision of prescription medication, including both autonomous and cooperative decision-making, with the advanced practice registered nurse (APRN) and the physician contributing their respective expertise.(2)
"Collaborative Agreement for the Advanced Practice Registered Nurse's Prescriptive Authority for Controlled Substances" or "CAPA-CS" means the written document pursuant to KRS 314.042(11).(3)
"Collaborative Agreement for the Advanced Practice Registered Nurse's Prescriptive Authority for Nonscheduled Legend Drugs" or "CAPA-NS" means the written document pursuant to KRS 314.042(8).(4)
"Good standing" is defined by KRS 314.039.(5)
"Immediate family" means a spouse, parent, parent-in-law, stepparent, child, stepchild, son-in-law, daughter-in-law, sibling, stepsibling, brother-in-law, sister-in-law, grandparent, grandchild, spouse of grandparent or grandchild, or other person residing in the same residence as the APRN.(6)
"KBML" means the Kentucky Board of Medical Licensure.(7)
"PDMP" means the electronic prescription drug monitoring program system for monitoring scheduled controlled substances and medicinal cannabis currently in use in Kentucky pursuant to KRS 218A.202, including the Kentucky All Schedule Prescription Electronic Reporting (KASPER) System.Section 2.
(1)
The practice of the APRN shall be in accordance with the standards and functions established in scope and standards of practice statements adopted by the board in subsection (2) of this section.(2)
The following scope and standards of practice statements shall be adopted:(a)
AACN Scope and Standards for Acute Care Nurse Practitioner Practice;(b)
AACN Scope and Standards for Acute Care Clinical Nurse Specialist Practice;(c)
Neonatal Nursing: Scope and Standards of Practice;(d)
Nursing: Scope and Standards of Practice;(e)
Pediatric Nursing: Scope and Standards of Practice;(f)
Psychiatric- Mental Health Nursing: Scope and Standards of Practice;(g)
Scope of Practice for Nurse Practitioners;(h)
Standards of Practice for Nurse Practitioners;(i)
Scope of Nurse Anesthesia Practice;(j)
Standards for Nurse Anesthesia Practice;(k)
Standards for Office Based Anesthesia Practice;(l)
Standards for the Practice of Midwifery;(m)
Oncology Nursing Scope and Standards of Practice;(n)
The Women's Health Nurse Practitioner: Guidelines for Practice and Education;(o)
Definition of Midwifery and Scope of Practice of Certified Nurse-Midwives and Certified Midwives; and(p)
Standards for Professional Nursing Practice in the Care of Women and Newborns.Section 3.
CAPA-CS Practice Requirements for APRNs(1)
In the performance of advanced practice registered nursing, the APRN shall seek consultation or referral in those situations outside the APRN's scope of practice.(2)
An APRN wishing to have a CAPA-CS in the first year of the APRN's licensure must be employed by a health care entity or provider. If the employing provider is an APRN, the employing APRN shall have been granted an exemption under Section 7 of this administrative regulation.(3)
During term of the CAPA-CS, the APRN and the collaborating physician shall meet, in person or via video conferencing, or by phone, if in person or video conferencing is not feasible, to review the APRN's reverse PDMP report. The review may include information from the patient's medical record that relates to the condition or conditions being treated with controlled substances by the APRN.(a)
Both the APRN and the physician shall maintain a record of:1.
The meeting date;2.
A summary of discussions; and3.
Any recommendations made shall be made in writing.(b)
The record shall be maintained by both parties for a period of one (1) year past the expiration of the APRN CAPA-CS.(c)
The APRN's meeting records shall be subject to audit by the board and the physician's records shall be subject to audit by the KBML. The sole purpose of the audit shall be to document that the collaboration meetings have taken place to verify compliance with this section.(4)
In the first year of the CAPA-CS, the APRN and a physician shall meet at least quarterly; and(5)
In the ensuing three (3) years of the CAPA-CS, the APRN and the physician shall meet at least biannually.Section 4.
Advanced practice registered nursing shall include prescribing and administering medications, as well as ordering treatments, devices, diagnostic tests, and performing certain procedures that shall be consistent with the scope and standards of practice of the APRN.Section 5.
Advanced practice registered nursing shall not preclude the practice by the APRN of registered nursing practice as defined by KRS 314.011(6).Section 6.
(1)
(a)
A CAPA-NS and a CAPA-CS shall include the:1.
Name;2.
Practice address;3.
Phone number;4.
License number of both the APRN and each physician who is a party to the agreement; and5.
Population focus and area of practice of the APRN and each physician.(b)
An APRN shall use a CAPA-NS Agreement.(c)
An APRN shall use the Standardized CAPA-CS Form.(2)
(a)
To notify the board of the existence of a CAPA-NS pursuant to KRS 314.042(8)(b), the APRN shall submit an online notification.(b)
To notify the board that the requirements of KRS 314.042(9) have been met and that the APRN will be prescribing nonscheduled legend drugs without a CAPA-NS, the APRN shall submit an online notification.(c)
To notify the board of the existence of a CAPA-CS pursuant to KRS 314.042(11)(b), the APRN shall submit an online notification.(d)
To notify the board that the requirements of KRS 314.042(14) have been met and request that the APRN be exempt from prescribing scheduled legend drugs under a CAPA-CS, the APRN shall complete the request for APRN exemption from CAPA-CS prescriptive authority and pay the listed fee in administrative regulation 201 KAR 20:240, Section 3(1)(e). Each submitted request shall be subject to the fee, regardless of whether the board grants the exemption after making a determination under Section 7 of this administrative regulation.(e)
All notifications, rescissions, and exemption requests shall be submitted by the APRN to the board via the online KBN Nurse Portal at www.kbn.ky.gov, and shall include the information and documentation required by subsections (1) and (2) of this section.(f)
Upon request by the Board, the APRN shall furnish to the board a copy of the executed CAPA-NS Agreement or Standardized CAPA-CS Agreement Form.(3)
For purposes of the CAPA-NS and the CAPA-CS, in determining whether the APRN and the collaborating physician are qualified in the same or a similar specialty, the board shall consider the facts of each particular situation and the scope of the APRN's and the physician's actual practice.(4)
An APRN with controlled substance prescriptive authority, shall:(a)
Obtain a United States Drug Enforcement Administration (DEA) Controlled Substance Registration Certificate and shall report the APRN's Kentucky DEA number, and any change in the status of a certificate by providing a copy of each registration certificate to the board within thirty (30) days of issuance.(b)
Register for a master account with the PDMP, within thirty (30) days of obtaining a DEA Controlled Substance Registration Certificate, and prior to prescribing controlled substances. A copy of the PDMP master account registration certificate shall be submitted to the board via the online KBN Nurse Portal within thirty (30) days of receipt of confirmation of registration by the PDMP.(5)
An APRN shall report any changes to a CAPA-NS or a CAPA-CS to the board within thirty (30) days.(6)
If an APRN's CAPA-NS or CAPA-CS ends unexpectedly for reasons outside the APRN's control such as being ended by the physician without notice, the physician's license becoming no longer valid in Kentucky, or the death of a physician, the APRN may continue to prescribe for thirty (30) days, after documenting in each patient's medical record the applicant's professional determination that the continued prescribing is justified based on the individual facts applicable to the patient's diagnosis and treatment. This thirty (30) day grace period shall not be extended or occur successively.(7)
An APRN with a CAPA-NS or a CAPA-CS shall report a practice address to the board. A change to the practice address shall be reported to the board within thirty (30) days.(8)
All documents and information required to be reported to the board by this section shall be reported by uploading the document or information through the board's Web site, https://kbn.ky.gov. The board shall not accept documents or information sent in any other format.Section 7.
CAPA-CS Exemption Review Request.(1)
An APRN who wishes to request a CAPA-CS exemption pursuant to KRS 314.042(14) shall:(a)
Complete a CAPA-CS exemption review request the board's website as required in Section 6(8) of this administrative regulation;(b)
Submit the fee required by 201 KAR 20:240, Section 3(1)(e); and(c)
Comply with the requirements established in KRS 314.042(14) and this administrative regulation.(2)
Upon receipt of the CAPA-CS exemption review request, the board shall verify the following:(a)
The APRN has had four (4) years of controlled substance prescribing authority;(b)
The APRN's license is in good standing;(c)
The APRN has maintained a DEA registration and a current registration certificate is on file with the board;(d)
The APRN has maintained a PDMP registration and a current registration is on file with the board;(e)
That a current Notification of a CAPA-CS for the APRN is on record with the board; and(f)
The APRN has an active account with the PDMP.(3)
Upon receipt of the CAPA-CS exemption review request, the board shall:(a)
Perform a criminal background check for any unreported misdemeanor or felony convictions in Kentucky; and(b)
Perform a check of the coordinated licensure information system specified in KRS 314.475 for any unreported disciplinary actions in another state.(4)
The APRN submitting the request shall cooperate with supplemental requests for documentation before the board makes a determination that the APRN's license is in good standing pursuant to KRS 314.042(14).(5)
An APRN wishing to practice in Kentucky through licensure by endorsement may request an exemption under this section.(a)
An APRN wishing to practice in Kentucky through licensure by endorsement is exempt from the CAPA-CS requirement if the APRN:1.
Has met the prescribing requirements for controlled substances in a state that grants such prescribing authority to APRNs;2.
Has had authority to prescribe controlled substances for at least four (4) years; and3.
Has a license in good standing.(b)
An APRN wishing to practice in Kentucky through licensure by endorsement who has had the authority to prescribe controlled substances for less than four (4) years and wishes to continue to prescribe controlled substances shall enter into a CAPA-CS with a physician licensed in Kentucky and comply with the provisions of KRS 314.042(11), until the requirements of this section are met.(6)
If the board determines that the APRN is eligible for the exemption after a review and determination of the exemption request under this section, the board shall notify the APRN in writing that the CAPA-CS is no longer required. The board shall not require the APRN to maintain a CAPA-CS as a condition to prescribe controlled substances unless the board imposes such a requirement as part of an action instituted under KRS 314.091(1).(7)
If the board denies the exemption request, the denial shall be in writing and shall state the reasons for the denial. The requestor may request a hearing pursuant to KRS 13B within twenty (20) days of receiving written notification of the denial. If a hearing is requested and the order of the board is adverse to the advance practice registered nurse, the board may impose costs pursuant to administrative regulation 201 KAR 20:162, Section 7.(8)
The APRN nurse shall not prescribe controlled substances without a CAPA-CS until the board has completed its review and has notified the APRN in writing that the APRN is exempt from the CAPA-CS requirement.Section 8.
Prescribing Medications without Prescriptive Authority. Prescribing nonscheduled legend drugs without a CAPA-NS or prescribing controlled substances without a CAPA-CS shall constitute a violation of KRS 314.091(1), unless;(1)
In the case of nonscheduled legend drugs, the CAPA-NS has been discontinued pursuant to KRS 314.042(9) or if the prescribing occurred within the grace period established in Section 6(6) of this administrative regulation; or(2)
In the case of controlled substances, the APRN was granted an CAPA-CS exemption by the Board under KRS 314.042(14)(e) prior to the date the medications were prescribed.Section 9.
The board may make an unannounced visit to an APRN's practice to determine if the it is consistent with the requirements established by KRS Chapter 314 and 201 KAR Chapter 20. Patient and prescribing records shall be made available for immediate inspection.Section 10.
Prescribing Standards for Controlled Substances.(1)
(a)
This section shall apply to APRNs with controlled substance prescriptive authority. It also applies to the utilization of the PDMP.(b)
The APRN shall practice according to the applicable scope and standards of practice for the APRN's role and population focus. This section does not alter the prescribing limits established in KRS 314.011(8).(2)
Prior to the initial prescribing of a controlled substance to a patient, the APRN shall:(a)
Obtain the patient's medical history, including history of substance use, and conduct an examination of the patient and document the information in the patient's medical record. An APRN certified in psychiatric-mental health shall obtain a medical and psychiatric history, perform a mental health assessment, and document the information in the patient's medical record;(b)
Query the PDMP for the twelve (12) month period immediately preceding the request for available data on the patient and maintain all PDMP report identification numbers and the date of issuance of each PDMP report in the patient's record;(c)
Develop a written treatment plan stating the objectives of the treatment and further diagnostic examinations required; and(d)
Discuss with the patient, the patient's parent if the patient is an unemancipated minor child, or the patient's legal guardian or health care surrogate:1.
The risks and benefits of the use of controlled substances, including the risk of tolerance and drug dependence;2.
That the controlled substance shall be discontinued once the condition requiring its use has resolved; and3.
Document that the discussion occurred and obtain written consent for the treatment.(3)
The treatment plan shall include an exit strategy, if appropriate, including potential discontinuation of the use of controlled substances.(4)
For subsequent or continuing long-term prescriptions of a controlled substance for the same medical complaint, the APRN shall:(a)
Update the patient's medical history and document the information in the patient's medical record;(b)
Modify and document changes to the treatment plan as clinically appropriate; and(c)
Discuss the risks and benefits of any new controlled substances prescribed, including the risk of tolerance and drug dependence with the patient, the patient's parent if the patient is an unemancipated minor child, or the patient's legal guardian or health care surrogate.(5)
During the course of treatment, the APRN shall query the PDMP no less than once every three (3) months for the twelve (12) month period immediately preceding the request for available data on the patient. The APRN shall maintain in the patient's record all PDMP report identification numbers and the date of issuance of each PDMP report or a copy or saved image of the PDMP report. If neither an identification number nor an image can be saved to the patient's record as a result of technical limitations of the APRN's electronic health record system, the APRN shall make a concurrent note in the patient's record documenting the date and time that the APRN reviewed the patient's PDMP report.(6)
These requirements may be satisfied by other licensed practitioners in a single group practice if:(a)
Each licensed practitioner involved has lawful access to the patient's medical record;(b)
Each licensed practitioner performing an action to meet these requirements is acting within the scope of practice of his or her profession; and(c)
There is adequate documentation in the patient's medical record reflecting the actions of each practitioner.(7)
If prescribing a controlled substance for the treatment of chronic, non-cancer pain, the APRN, in addition to the requirements of this section, shall obtain a baseline drug screen and further random drug screens if the APRN:(a)
Finds a drug screen clinically appropriate; or(b)
Believes that it is appropriate to determine whether the controlled substance is being taken by the patient.(8)
If prescribing a controlled substance for the treatment of a mental health condition, the APRN shall meet the requirements of this section and KRS 314.011(8)(a) and (b).(9)
Prior to prescribing a controlled substance for a patient in the emergency department of a hospital that is not an emergency situation, the APRN shall:(a)
Obtain the patient's medical history, conduct an examination of the patient, and document the information in the patient's medical record. An APRN certified in psychiatric - mental health shall obtain a medical and psychiatric history, perform a mental health assessment, and document the information in the patient's medical record;(b)
Query the PDMP for the twelve (12) month period immediately preceding the request for available data on the patient and document the data in the patient's record;(c)
Develop a written treatment plan stating the objectives of the treatment and further diagnostic examinations required; and(d)
Discuss the risks and benefits of the use of controlled substances with the patient, the patient's parent if the patient is an unemancipated minor child, the patient's legal guardian, or health care surrogate, including the risks of tolerance and drug dependence, and document that the discussion occurred and that the patient consented to that treatment.(10)
For each patient for whom an APRN prescribes a controlled substance, the APRN shall keep accurate, readily accessible, and complete medical records, which include:(a)
Medical history and physical or mental health examination;(b)
Diagnostic, therapeutic, and laboratory results;(c)
Evaluations and consultations;(d)
Treatment objectives;(e)
Discussion of risk, benefits, and limitations of treatments;(f)
Treatments;(g)
Medications, including date, type, dosage, and quantity prescribed;(h)
Instructions and agreements;(i)
Periodic reviews of the patient's file; and(j)
All PDMP report identification numbers and the date of issuance of each PDMP report.(11)
The requirement to query the PDMP shall not apply to:(a)
An APRN prescribing or administering a controlled substance immediately prior to, during, or within the fourteen (14) days following an operative or invasive procedure or a delivery if the prescribing or administering is medically related to the operative or invasive procedure of the delivery and the medication usage does not extend beyond the fourteen (14) days;(b)
An APRN prescribing or administering a controlled substance necessary to treat a patient in an emergency situation; or(c)
An APRN prescribing a controlled substance:1.
For administration in a hospital or long-term-care facility with an institutional account, or an APRN in a hospital or facility without an institutional account, if the hospital, long-term-care facility, or licensee queries the PDMP for all available data on the patient or resident for the twelve (12) month period immediately preceding the query within twelve (12) hours of the patient's or resident's admission and places a copy of the query in the patient's or resident's medical records during the duration of the patient's stay at the facility;2.
As part of the patient's hospice or end-of-life treatment;3.
For the treatment of pain associated with cancer or with the treatment of cancer;4.
To assist a patient with submitting to a diagnostic test or procedure;5.
Within seven (7) days of an initial prescription pursuant to subsection (1) of this section if the prescriber:a.
Substitutes a controlled substance for the initial prescribing;b.
Cancels any refills for the initial prescription; andc.
Requires the patient to dispose of any remaining unconsumed medication;6.
Within ninety (90) days of an initial prescription pursuant to subsection (1) of this section if the prescribing is done by another licensee in the same practice or in an existing coverage arrangement, if done for the same patient for the same condition;7.
To a research subject enrolled in a research protocol approved by an institutional review board that has an active federal-wide assurance number from the United States Department of Health and Human Services, Office for Human Research Protections if the research involves single, double, or triple blind drug administration or is additionally covered by a certificate of confidentiality from the National Institutes of Health;8.
During the effective period of any disaster or situation with mass casualties that have a direct impact on the APRN's practice;9.
As part of the administering or ordering of controlled substances to prisoners in a state, county, or municipal correctional facility;10.
That is a Schedule IV controlled substance for no longer than three (3) days for an established patient to assist the patient in responding to the anxiety of a nonrecurring event; or11.
That is classified as a Schedule V controlled substance.(12)
In accordance with 21 C.F.R. 1306.12(b)(1)(iv) - (v), federal regulation 21 C.F.R. 1306.12(b) concerning the issuance of multiple prescriptions for Schedule II controlled substances shall not apply to APRNs in this state.(13)
No less than once every six (6) months, an APRN who holds a DEA Controlled Substance Registration Certificate shall review a reverse PDMP report for the preceding six (6) months to determine if the information contained in the PDMP is correct. If the information is incorrect, the APRN shall comply with 902 KAR 55:110 and take the necessary steps to seek correction of the information, by:(a)
First contacting the reporting pharmacy;(b)
Contacting law enforcement if suspected fraudulent activity; or(c)
Contacting the Drug Enforcement Professional Practices Branch, Office of Inspector General, Cabinet for Health and Family Services.(14)
An APRN shall not issue a prescription for hydrocodone combination products for more than a three (3) day supply if the prescription is intended to treat pain as an acute medical condition, except if:(a)
The APRN, in his or her professional judgment, believes that more than a three (3) day supply of hydrocodone combination products is medically necessary to treat the patient's pain as an acute medical condition and the APRN adequately documents the acute medical condition and lack of alternative treatment options that justifies deviation from the three (3) day supply limit on the patient's medical records;(b)
The prescription for hydrocodone combination products is prescribed to treat chronic pain;(c)
The prescription for hydrocodone combination products is prescribed to treat pain associated with a valid cancer diagnosis;(d)
The prescription for hydrocodone combination products is prescribed to treat pain while the patient is receiving hospice or end-of-life treatment;(e)
The prescription for hydrocodone combination products is prescribed as part of a narcotic treatment program licensed by the Cabinet for Health and Family Services;(f)
The prescription for hydrocodone combination products is prescribed to treat pain following a major surgery, which is any operative or invasive procedure or a delivery, or the treatment of significant trauma; or(g)
Hydrocodone combination products are administered directly to an ultimate user in an inpatient setting.(15)
Prescriptions written for hydrocodone combination products pursuant to subsection (14)(a) through (g) of this section shall not exceed thirty (30) days without any refill.(16)
An APRN may prescribe electronically. Electronic prescription shall be as established in KRS 218A.171.(17)
For any prescription for a controlled substance, the prescribing APRN shall discuss with the patient the effect the patient's medical condition and medication may have on the patient's ability to safely operate a vehicle in any mode of transportation.Section 11.
Immediate Family and Self-prescribing or Administering Medications.(1)
An APRN shall not self-prescribe or administer controlled substances.(2)
An APRN shall not prescribe or administer controlled substances to his or her immediate family except as established in subsections (3) and (4) of this section.(3)
An APRN may prescribe or administer controlled substances to an immediate family member:(a)
In an emergency situation;(b)
For a single episode of an acute illness through one (1) prescribed course of medication; or(c)
In an isolated setting, if no other qualified practitioner is available.(4)
(a)
An APRN who prescribes or administers controlled substances for an immediate family member pursuant to subsections (3)(a) or (b) of this section shall document all relevant information and notify the appropriate provider.(b)
An APRN who prescribes or administers controlled substances for an immediate family member pursuant to subsection (3)(c) of this section shall maintain a provider-practitioner relationship and appropriate patient records.Section 12.
Incorporation by Reference.(1)
The following material is incorporate by reference:(a)
"AACN Scope and Standards for Acute Care Nurse Practitioner Practice", 2017 Edition, American Association of Critical-Care Nurses;(b)
"ACCN Scope and Standards for Acute Care Clinical Nurse Specialist Practice", 2014 Edition, American Association of Critical-Care Nurses;(c)
"Neonatal Nursing: Scope and Standards of Practice", 2013 Edition, American Nurses Association/ National Association of Neonatal Nurses;(d)
"Nursing: Scope and Standards of Practice", 2015 Edition, American Nurses Association;(e)
"Pediatric Nursing: Scope and Standards of Practice", 2015 Edition, American Nurses Association/ Society of Pediatric Nursing/ National Association of Pediatric Nurse Practitioners;(f)
"Psychiatric-Mental Health Nursing: Scope and Standards of Practice", 2014, American Nurses Association/ American Psychiatric Nursing Association;(g)
"Scope of Practice for Nurse Practitioners", 2019 Edition, American Association of Nurse Practitioners;(h)
"Standards of Practice for Nurse Practitioners", 2019 Edition, American Association of Nurse Practitioners;(i)
"Scope of Nurse Anesthesia Practice", 2013 Edition, American Association of Nurse Anesthetists;(j)
"Standards for Nurse Anesthesia Practice", 2019 Edition, American Association of Nurse Anesthetists;(k)
"Standards for Office Based Anesthesia Practice", 2019 Edition, American Association of Nurse Anesthetists;(l)
"Standards for the Practice of Midwifery", 2011 Edition, American College of Nurse Midwives;(m)
"Oncology Nursing Scope and Standards of Practice", 2019 Edition, Oncology Nursing Society;(n)
"The Women's Health Nurse Practitioner: Guidelines for Practice and Education", 2014 Edition, Association of Women's Health, Obstetric and Neonatal Nurses/Nurse Practitioners in Women's Health;(o)
"Definition of Midwifery and Scope of Practice of Certified Nurse-Midwives and Certified Midwives", 2012 Edition, American College of Nurse Midwives;(p)
"Standards for Professional Nursing Practice in the Care of Women and Newborns", 2019 Edition, Association of Women's Health, Obstetric and Neonatal Nurses;(q)
"Standardized CAPA-CS Agreement Form", _9/2023; and(r)
"CAPA-NS Agreement Form", 9/2023.(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Board of Nursing, 312 Whittington Parkway, Suite 300, Louisville, Kentucky 40222, Monday through Friday, 8 a.m. to 4:30 p.m. This material is also available on the board's Web site at https://kbn.ky.gov/General/Pages/Document-Library.aspx.AUDRIA DENKER, President
APPROVED BY AGENCY: January 5, 2024
FILED WITH LRC: January 11, 2024 at 10:05 a.m.
CONTACT PERSON: Jeffrey R. Prather, General Counsel, Kentucky Board of Nursing, 312 Whittington Parkway, Suite 300, Louisville, Kentucky 40222, (502) 338-2851, Jeffrey.Prather@ky.gov. cky.gov/formservices/Nursing/PendReg.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Jeffrey Prather
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation sets standards for APRN practice.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary because of KRS 314.042.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation conforms to the content of the authorizing statutes by setting standards of practice.
(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 setting standards of practice.
(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:
The amendment clears up regulatory language to use "APRN"; adds definitions for "Good standing", "Immediate family" and "PDMP" (prescription drug monitoring program). It establishes regulatory standards for APRNs engaged in a CAPA-CS, including creation of a new CAPA-CS form. The amendments further provide for the regulatory process by which an APRN may request an exemption from the CAPA-CS requirement, in accordance with Senate Bill (SB) 94 (2023RS).
(b) The necessity of the amendment to this administrative regulation:
These regulation amendments were necessary due to SB 94, and the changes to KRS 314.042.
(c) How the amendment conforms to the content of the authorizing statutes:
By clearly stating requirements.
(d) How the amendment will assist in the effective administration of the statutes:
By clearly stating standards, procedures, and requirements.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
Kentucky APRNs, approximately 14,000 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:
APRNs who wish to be in a CAPA-CS will need to use the form incorporated by reference. If the wish to request an exemption, they must be in good standing, provide a DEA and a PDMP registration, and meet the 4-year prescribing requirement.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
No additional cost, other than the exemption request fee in 201 KAR 20:240, which is mandated by KRS 314.042(14)(b)(4),
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
They will be in compliance with the administrative regulation and KRS 314.042, and will be authorized to prescribe controlled substances.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
No additional cost.
(b) On a continuing basis:
No additional cost.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Agency funds.
(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 fees are increased; however, a fee of $50 has been proposed in 201 KAR 20:240, which is mandated by KRS 314.042(14)(b)(4), and currently in promulgation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This regulation does not establish a fee; however, see KRS 314.042(14)(b)(4), and 201 KAR 20:240.
(9) TIERING: Is tiering applied?
The changes will apply equally, there is no tiering.
FISCAL NOTE
(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?
Board of Nursing.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
Kentucky Revised Statutes KRS 218A.205(3)(a), (b), 314.131(1), 314.042, and 314.193.
(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?
None.
(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?
None.
(c) How much will it cost to administer this program for the first year?
No additional cost.
(d) How much will it cost to administer this program for subsequent years?
No additional cost.
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:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
None.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
None.
(c) How much will it cost the regulated entities for the first year?
None.
(d) How much will it cost the regulated entities for subsequent years?
None.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
Expenditures (+/-):
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This administrative regulation will not have a major economic impact.