Kansas Attorney General Opinion 2022-004

March 24, 2022
ATTORNEY GENERAL OPINION NO. 2022- 4
The Honorable Ty Masterson
Kansas Senate President
300 SW 10th Room 333-E
Topeka, KS 66612
Re: 	Procedure, Civil—COVID-19 Response and Reopening for Business Liability
Act—Definitions; Healthcare Provider Immunity; COVID-19 Public Health
Emergency; Immunity Related to Qualified Products
Public Health—Healing Arts—Revocation, Suspension, Limitation or Denial of
Licenses; Censure of Licensee; Grounds; Definitions
Public Health—Physician Assistants—Definitions; Revocation, Suspension,
Limitation, Censure or Denial of License; Practice of Physician Assistant;
Direction and Supervision of Physician; Prescription of Drugs; Rules and
Regulations; Drug Defined
Public Health—Regulation of Nursing—Definitions; Grounds for Disciplinary
Actions; 	Advanced 	Practice 	Registered 	Nurse; 	Rules 	and 	Regulations;
Prescription of Drugs Authorized
Synopsis: 	Kansas law does not prohibit physicians and other authorized prescribers from
prescribing 	FDA 	approved 	generic 	drugs 	such 	as 	ivermectin 	and
hydroxychloroquine for off-label uses in the prevention or treatment of COVID-
19 so long as the healthcare provider meets the standard of care obligations
to the patient in the process. Cited herein: 	K.S.A. 2021 Supp. 60-5501; 60-
5502; 60-5503; 60-5505; 65-1113; 65-1120; 65-1130; 65-2836; K.S.A. 65-
2837; 65-2869; 65-2870; 65-28a02; 65-28a-05; 65-28a-08; K.A.R. 100-28a-8;
100-28a-7

The Honorable Ty Masterson
Page 2
* 	* 	*
Dear Senator Masterson:
As Senate President and Senator for the 16 th District you request our opinion on the following
question of law: “Does Kansas law prevent physicians or other prescribers from prescribing
FDA approved generic drugs such as ivermectin and hydroxychloroquine for off-label uses
in the treatment of COVID-19?” For the reasons explained below, we opine that the answer
is no if the physician or other authorized prescriber under the appropriate licensing statutes
meets the standard of care and conduct obligations to the patient.
Food and Drug Administration & Off Label Usage
As one of its numerous responsibilities, the U. S. Food and Drug Administration (FDA) is
charged with ensuring the safety and effectiveness of drugs and medical devices. 1 Prior to
granting lawful use of a drug the FDA requires that manufacturers undergo rigorous
application and approval processes demonstrating proof of both safety and efficacy for the
intended use, which use is then set out on the product label. 2 While the FDA is charged with
approving drugs, it does not have the authority to constrain the practice of medicine.3 Once
drugs are approved by the FDA for lawful sale, medical professionals “exercise their
independent medical judgment to prescribe FDA approved drugs to treat conditions other
than those for which the drug is approved, if appropriate for a particular patient” which is
commonly referred to as “off-label” usage. 4 Off-label usage includes differing dosages than
were initially tested or used in different patient populations from the clinical trials. Off-label
usage also occurs where, in the medical judgement of the prescriber, it would benefit the
patient when other drugs have failed. The United States Supreme Court has similarly
recognized and affirmed the off-label use of FDA approved medical devices and noted
further that the FDA has affirmed the validity of such off-label prescriptions. 5 	The Kansas
Board of Healing Arts (BOHA) agrees, stating that “[o]ff label drug prescription is not
uncommon, existed prior to the pandemic, and is not prohibited explicitly by federal or state
law.” 6 The Board emphasizes that healthcare professionals must comply with the standard
of care.7 In the COVID-19 Response and Reopening for Business Liability Protection Act 8 ,
the Kansas Legislature recognized the potential need for off-label use of drugs during the
COVID-19 pandemic. 	The legislature granted some civil immunity to healthcare providers
for healthcare decisions made in response to COVID-19 between March 12, 2020 and March
1 https://www.fda.gov/regulatory-information/laws-enforced-fda (last accessed 3/15/22).
2 Goico v. United States Gov’t, No. 20-1248-JAR, 2020WL 7078731, (D.Kan. Dec. 3, 2020).
3 Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 350 (2001) (citations omitted).
4 Goico v. United States Gov’t, No. 20-1248-JAR, 2020WL 7078731, (D.Kan. Dec. 3, 2020). For a discussion
by the FDA of off-label usage of FDA approved drugs see also https://www.fda.gov/patients/learn-about-
expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label (last
accessed 3/5/22).
5 Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 350 (2001) (citations omitted).
6 Susan Gile, Acting Executive Director of the Kansas Board of Healing Arts, dated March 4, 2022, p.1.
7 Id.
8 K.S.A. 2021 Supp. 60-5501 et. seq.

The Honorable Ty Masterson
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31, 	2022. 9 	Additionally 	the 	legislature 	provided 	for 	specific 	immunity 	in 	certain
circumstances related to “medications used to treat COVID-19, including medications
prescribed or dispensed for offlabel (sic) use to attempt to combat COVID-19.”10
COVID-19, Ivermectin, & Hydroxychloroquine
COVID-19 is a disease caused by the SARS-CoV-2 virus, a member of the coronavirus
family, that can cause a variety of symptoms, from colds to severe respiratory illnesses and
even death. 11 The virus spreads through the air in the same manner as other respiratory
viruses. 12 As of March 14, 2022, Kansas recorded 768,820 cases of COVID-19, with 8,028
deaths attributed to the virus. 13 Currently, the only FDA approved drug for the treatment of
COVID-19 is remdesivir, which was approved on October 22, 2020. 14 The drugs you cite in
your question, ivermectin and hydroxychloroquine, have been studied for their possible
efficacy in the prevention and treatment of COVID-19. 15 The opinions offered by the Kansas
Attorney General related to the off-label prescribing of drugs are limited to questions of law
and not to factual considerations related to the prescribing of a particular drug for a particular
condition.
Kansas Healing Arts Act
Under the Kansas Healing Arts Act, a physician is licensed to practice medicine and surgery
or osteopathic medicine and surgery by the Kansas Board of Healing Arts. 16 A physician
may be subject to discipline for committing professional incompetency or for an act of
unprofessional or dishonorable conduct. 17 Professional incompetency for purposes of this
opinion relates to the adherence to the applicable standard of care.18 Unprofessional
conduct is defined by K.S.A. 65-2837 and for purposes of this opinion includes: “[m]aking a
false or misleading statement regarding the licensee’s skill or the efficacy or value of the
drug, treatment, or remedy prescribed by the licensee or at the licensee’s direction in the
treatment of any disease or other condition of the body or mind;” 19 “[p]rescribing, dispensing,
9 K.S.A. 2021 Supp. 60-5503.
10 K.S.A. 2021 Supp. 60-5505; 60-5502(k)(4).
11
https://www.cdc.gov/coronavirus/2019-ncov/your-health/about-covid-19/basics-covid-19.html (last accessed
3/15/22).
12
https://www.cdc.gov/coronavirus/2019-ncov/your-health/about-covid-19/basics-covid-19.html (last accessed
3/15/22).
13
https://www.coronavirus.kdheks.gov/DocumentCenter/View/1529/February-28-Case-Summary-PDF?bidId=
(last accessed 3/15/22).
14 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-
frequently-asked-questions#drugs (last accessed 3/15/22).
15
See Douglas J. Peterson Opinion 21-017 for a detailed discussion of the clinical trials and conflicting medical
opinions related to the use of both ivermectin and hydroxychloroquine in the prevention and early treatment of
COVID-19. https://ago.nebraska.gov/sites/ago.nebraska.gov/files/docs/opinions/21-017_0.pdf (last accessed
3/15/22).
16 See K.S.A. 65-2869 and K.S.A.65-2870; Attorney General Opinion No. 2020-2.
17 K.S.A. 2021 Supp. 65-2836(b).
18 K.S.A. 65-2837(a)(1)-(2).
19 K.S.A. 65-2837(b)(13).

The Honorable Ty Masterson
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administering or distributing a prescription drug or substance, including a controlled
substance, in an improper or inappropriate manner, or for other than a valid medical purpose
. . .;”20 or “[u]sing experimental forms of therapy without proper informed patient consent,
without conforming to generally accepted criteria or standard protocols . . . .”21 Additionally,
a physician may be disciplined if they have “prescribed, sold, administered, distributed or
given a controlled substance to any person for other than medically accepted or lawful
purposes.” 22
Physician Assistant Licensure Act
A physician assistant is a person licensed by the BOHA who “provides patient services under
the direction and supervision of a supervising physician.” 23 	Physician assistants may
“prescribe 	drugs 	pursuant 	to 	a 	written 	agreement 	as 	authorized 	by 	the 	supervising
physician” 24 and subject to rules and regulations adopted by BOHA. 25 A physician assistant
may be subject to discipline for the commission of an act of unprofessional conduct 26 or
professional 	incompetency. 27 	Unprofessional 	conduct 	is 	“prescribing, 	dispensing,
administering, or distributing a prescription drug or substance … in an excessive, improper,
or inappropriate manner or quantity, or not in the course of the licensee’s professional
practice.”28 Professional incompetency is related to adherence to the applicable standard of
care. 29 Additionally, a physician assistant may be subject to discipline for acting “outside the
scope of authority given the physician assistant by the supervising physician.” 30
Kansas Nurse Practice Act
Under the Kansas Nurse Practitioner Act, an advanced practice registered nurse (APRN) is
a professional nurse who is licensed by the Kansas State Board of Nursing (KSBN) to
function in an advanced role. 31 An APRN may prescribe drugs “pursuant to a written protocol
as authorized by a responsible physician.” 32 An APRN may be subject to discipline for
20 K.S.A. 65-2837(b)(23).
21 K.S.A. 65-2837(b)(27).
22 K.S.A. 2021 Supp. 65-2836(p).
23 K.S.A. 65-28a02(4).
24 K.S.A. 65-28a08(b)(1). K.S.A. 65-28a08(f) defines “drug” as those articles and substances defined as drugs
in K.S.A. 65-1626 and K.S.A. 65-4101, and amendments thereto.
25 K.S.A. 65-28a08(d)(2). See K.A. R. 100-28a-13 for the specific prescribing parameters for physician
assistants. This Opinion assumes that the physician assistant has followed all relevant regulations for authority
to prescribe the drugs in question.
26 K.S.A. 65-28a05(a).
27 K.S.A. 65--28a05(c).
28 K.A.R. 100-28a-8(j).
29 K.A.R. 100-28a-7.
30 K.S.A. 68-28a05(o).
31 K.S.A. 65-1113.
32 K.S.A. 65-1130(d). The requirements for said protocols are set out in K.A.R. 60-11-104a. Drugs as defined
in K.S.A. 65-1130 are those substances defined as drugs in K.S.A. 65-1626 and K.S.A. 65-4101 thus an APRN
may prescribe permitted drugs pursuant to an appropriate protocol. This opinion assumes that all protocols
have been adopted and followed.

The Honorable Ty Masterson
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committing “an act of professional incompetence” 33 which includes “failure to adhere to the
applicable standard of care.”34
In other words, a factual question arises because the ‘particular decisions and acts
required to satisfy that duty of care vary . . . . What constitutes negligence in a
particular situation is judged by the professional standards of the particular area of
medicine 	involved.’ 	As 	a 	result, 	the 	applicable 	standard 	of 	care 	is 	generally
established through expert testimony ‘except where lack of reasonable care . . . is
apparent to an average layperson from common knowledge or experience. 35
Standard of Care
Under Kansas law, the authorized prescribers discussed herein are all subject to discipline
for failure to follow the standard of care in a particular circumstance. It is the healthcare
provider’s duty “to use the learning and skill ordinarily used by other members of that same
field of medicine in the same or similar communities and circumstances. In using this
learning and skill, the [healthcare provider] must also use ordinary care and diligence. A
violation of this duty is negligence.” 36 	Ultimately, the determination as to whether a
healthcare provider has met the standard of care is a factual determination.
Thus, we conclude that nothing in Kansas or federal law prohibits the off-label prescribing
of FDA approved drugs such as ivermectin or hydroxychloroquine for the prevention or
treatment of COVID-19. 	In so prescribing, physicians and other prescribers are bound by
professional standards of care in the treatment of patients. Determinations as to standard of
care are factual determinations based on the particular circumstances of treatment and, as
such, is outside the scope of this opinion.
Sincerely,
Derek Schmidt
Kansas Attorney General
Sarah L. Shipman
Deputy Attorney General
DS:SLS:sb
33 K.S.A. 65-1120(a).
34 K.S.A. 65-1120(e).
35 Russell v. May, 400 P.3d 647, 658 (Kan. 2017).
36 Pattern Jury Instructions for Kansas – Civil 4 th
, 123.01, Duty of Health Care Provider (2021 update).