Before disciplining a Tennessee physician for prescribing ivermectin or hydroxychloroquine off-label for COVID-19, must the Board of Medical Examiners first promulgate a rule?

Plain-English summary

Two Tennessee legislators asked whether the Board of Medical Examiners had to write a rule before it could discipline a physician for prescribing ivermectin, hydroxychloroquine, or other medications off-label to treat COVID-19. The question arose against a politically charged 2021 backdrop in which the General Assembly had recently enacted Tenn. Code Ann. § 14-4-104, a procedural roadblock specific to COVID-19 prescribing discipline.

AG Slatery's answer was yes. The general rule is the opposite: under Tenn. Code Ann. § 63-6-214(b), the Board can discipline doctors for unprofessional or unethical conduct, gross negligence, and improper prescribing without first writing a separate rule. The list of grounds in § 63-6-214(b) is non-exhaustive. Tennessee case law (Perez, Gate Pharms.) confirms that the Board need not pre-define every disciplinable behavior to act.

But the General Assembly added a special procedural step in late 2021. Section 14-4-104, effective November 21, 2021, says: "Notwithstanding title 63 or 68 to the contrary, any disciplinary process, or action taken pursuant to such process, that is implemented by a health-related board regarding the dispensing or prescribing of medication for COVID-19 must be promulgated as a rule pursuant to title 4, chapter 5." Title 14, Chapter 4, Section 101(4) defines "COVID-19" broadly to include any SARS-CoV-2 variant. The "notwithstanding" clause overrides the general rule. So before the Board can move against a physician for COVID-19-related off-label prescribing, it must first complete a rulemaking under the Uniform Administrative Procedures Act, Tenn. Code Ann. tit. 4, ch. 5.

The opinion also explains the underlying medical and legal landscape. Off-label prescribing is generally permissible. The FDA does not regulate the practice of medicine; physicians can prescribe FDA-approved drugs for non-FDA-approved uses (Richardson v. Miller; Ass'n of Am. Physicians & Surgeons; 21 U.S.C. § 396). What can get a physician in trouble is prescribing that falls below the standard of care: careless, imprudent, or unprofessional decisions. The Board has long disciplined physicians for "unorthodox" or excessive prescribing under § 63-6-214(b)(1), (4), and (12). Section 14-4-104 doesn't change those substantive standards; it just adds a rulemaking prerequisite when the alleged misconduct involves COVID-19 medication.

What this means for you

If you are a Tennessee physician prescribing off-label for COVID-19

Under this opinion, before the Board of Medical Examiners can conduct a disciplinary proceeding against you "regarding the dispensing or prescribing of medication for COVID-19," it must first promulgate a rule under Title 4, Chapter 5 (§ 14-4-104, effective November 21, 2021). The opinion is explicit that this is procedural only: it does not change the substantive standard, and a physician "must still exercise his or her medical judgment and discretion in accordance with the applicable standard of care."

If you are a patient prescribed ivermectin or hydroxychloroquine for COVID-19

The opinion states that off-label use of an FDA-approved drug is not prohibited by the FDA, and that the FDA does not regulate physicians' off-label prescribing decisions. Whether a particular off-label prescription falls below the applicable standard of care is, per the opinion, a fact-specific question depending on the totality of the circumstances. The opinion does not address patient remedies or complaint procedures.

If you are a Tennessee Board of Medical Examiners member

The opinion concludes that § 14-4-104's "notwithstanding title 63 or 68" clause overrides the general rule (which otherwise lets the Board discipline without a rule under § 63-6-214(b)). For COVID-19 medication prescribing specifically, the Board must promulgate a rule under Title 4, Chapter 5 before conducting a disciplinary proceeding.

If you are a medical-malpractice attorney

The opinion is careful to say § 14-4-104 changes only the Board's process, not the substantive standard of care. It cites Richardson v. Miller for the rule that "[p]hysicians may be found negligent if their decision to use a drug off-label is sufficiently careless, imprudent or unprofessional," and notes the Board has disciplined off-label prescribing under § 63-6-214(b)(1), (4), and (12) (Johnson, Williams, Rich).

Common questions

Q: Can a Tennessee doctor legally prescribe ivermectin for COVID-19?
A: Off-label prescribing is legal in Tennessee. The FDA does not prohibit it. Whether a specific prescription meets the standard of care is a separate, fact-specific question that depends on the patient, the alternatives, and the evidence available at the time.

Q: What does Section 14-4-104 actually require?
A: It says the Board must promulgate a rule under the Uniform Administrative Procedures Act before it implements any disciplinary process for prescribing COVID-19 medication. Until that rule exists, a discipline action on those facts cannot move forward.

Q: Can the Board still discipline doctors for off-label prescribing for non-COVID conditions without first writing a rule?
A: Yes. The general law (Tenn. Code Ann. § 63-6-214(b) and Gate Pharms. v. Board) lets the Board act without a rule, because the statutory grounds are non-exhaustive. Section 14-4-104 only carves out the COVID-19 medication context.

Q: What kinds of off-label prescribing have led to discipline in Tennessee?
A: The opinion lists examples from case law: hydrogen peroxide treatment for skin conditions (Johnson), excessive prescribing for obesity (Williams), and the chelation, hydrogen peroxide, and methadone protocol challenged in Rich. Discipline turns on whether the prescribing fell below the applicable standard of care.

Q: Does this opinion say ivermectin or hydroxychloroquine work for COVID-19?
A: No. The AG opinion does not take a clinical position. It is purely about the Board's procedural authority to discipline doctors who prescribe these drugs off-label.

Q: Does this still apply if the General Assembly later amends § 14-4-104?
A: The opinion is necessarily a snapshot as of December 30, 2021. Title 14 has been amended in several legislative sessions since then. Anyone making a current decision should pull the most recent version of § 14-4-104 and any rules the Board has promulgated.

Q: What is "off-label" prescribing exactly?
A: It is prescribing an FDA-approved drug for a use, dose, or patient population that is not in the drug's FDA-approved labeling. The opinion cites Richardson v. Miller for the definition. It is a routine and legal part of medical practice across many specialties.

Background and statutory framework

Tennessee's Medical Practice Act, Tenn. Code Ann. § 63-6-101 et seq., gives the Board of Medical Examiners authority to license and discipline physicians. Section 63-6-214(b) lists twenty-two grounds for discipline, including unprofessional conduct (subsection (1)), gross negligence (subsection (4)), and dispensing or prescribing controlled substances or other drugs "not in the course of professional practice" or in amounts not medically necessary (subsection (12)). The list is explicitly non-exhaustive: "The grounds upon which the board shall exercise power, include, but are not limited to . . . ." Tennessee courts have recognized that the Board can discipline physicians for conduct that fits the spirit of the listed grounds even without rulemaking. Gate Pharms. v. Tenn. Bd. of Med. Exam'rs, 1996 WL 648424.

Off-label prescribing of FDA-approved drugs sits within the practice of medicine, an area the FDA explicitly does not regulate (21 U.S.C. § 396). The Tennessee Court of Appeals defined off-label use in Richardson v. Miller, 44 S.W.3d 1 (Tenn. Ct. App. 2000), and the Sixth Circuit reaffirmed the FDA's hands-off posture in Ass'n of Am. Physicians & Surgeons v. FDA, 13 F.4th 531 (6th Cir. 2021). What governs the legality of any specific off-label prescription is not the FDA but the standard of care, enforced through state medical boards and tort law. Tennessee courts have applied that standard to discipline cases for years (Johnson, Williams, Rich).

In late 2021 the General Assembly enacted Tenn. Code Ann. § 14-4-104 (effective November 21, 2021), which changes only the procedural rules, not the substantive standard. By inserting a "notwithstanding title 63 or 68" clause, the legislature overrode the Gate Pharms. baseline and required rulemaking before the Board can discipline a physician for COVID-19 medication prescribing. The definition of "COVID-19" in § 14-4-101(4) is broad: it covers SARS-CoV-2, all variants, and the disease commonly called COVID-19.

This is a narrow procedural carve-out, not a substantive immunity. It tells the Board: write a rule first, then enforce. It does not tell physicians that off-label COVID-19 prescribing is safe, lawful in every case, or beyond the standard of care. Civil malpractice exposure is unchanged.

Citations

• Tenn. Code Ann. § 14-4-104 (rulemaking required for COVID-19 medication discipline)
• Tenn. Code Ann. § 14-4-101(4) (definition of COVID-19)
• Tenn. Code Ann. § 63-6-101(a)(3) (Board's disciplinary hearing duty)
• Tenn. Code Ann. § 63-6-214(b) (grounds for physician discipline)
• Tenn. Code Ann. tit. 4, ch. 5 (Uniform Administrative Procedures Act)
• 21 U.S.C. § 396 (FDA practice-of-medicine limitation)
• Perez v. Tenn. Bd. of Med. Exam'rs., 2019 WL 2880980 (Tenn. Ct. App. 2019)
• Johnson v. Tenn. Bd. of Med. Exam'rs., 2003 WL 1442413 (Tenn. Ct. App. 2003)
• Williams v. State Dep't of Health and Env't, 880 S.W.2d 955 (Tenn. Ct. App. 1994)
• Rich v. Tenn. Bd. of Med. Exam'rs, 350 S.W.3d 919 (Tenn. 2011)
• Richardson v. Miller, 44 S.W.3d 1 (Tenn. Ct. App. 2000)
• Ass'n of Am. Physicians & Surgeons v. FDA, 13 F.4th 531 (6th Cir. 2021)
• Gate Pharms. v. Tenn. Bd. of Med. Exam'rs, 1996 WL 648424 (Tenn. Ct. App. 1996)

Subject

Disciplinary Proceedings Against Physicians Who Prescribe Medications "Off-Label" for COVID-19

Source

• Landing page: https://www.tn.gov/attorneygeneral/opinions.html
• Original PDF: https://www.tn.gov/content/dam/tn/attorneygeneral/documents/ops/2021/op21-19.pdf

Original opinion text

December 30, 2021
Opinion No. 21-19

Disciplinary Proceedings Against Physicians Who Prescribe Medications "Off-Label" for COVID-19

Question
Does the Tennessee Board of Medical Examiners have to promulgate a rule before a disciplinary proceeding can be instituted against a physician who prescribes a medication, such as ivermectin or hydroxychloroquine, for "off-label" use for the treatment of COVID-19?

Opinion
Yes. While disciplinary proceedings may generally be instituted against physicians under Tenn. Code Ann. § 63-6-214(b) in the absence of a rule, Tenn. Code Ann. § 14-4-104 requires the Board of Medical Examiners to promulgate a rule before it conducts a disciplinary proceeding against a physician "regarding the dispensing or prescribing of medication for COVID-19."

ANALYSIS

Under the Tennessee Medical Practice Act, the Board of Medical Examiners (the "Board") has the duty to conduct disciplinary hearings involving physicians. See Tenn. Code Ann. § 63-6-101(a)(3). Tennessee Code Annotated § 63-6-214(b)(1)-(22) lists twenty-two grounds on which the Board may discipline a physician. Other conduct not specifically listed in § 63-6-214(b)(1)-(22) can also result in discipline since the list, by its own terms, is not exhaustive. Perez v. Tenn. Bd. of Med. Exam'rs., M2018-00960-COA-R3-CV, 2019 WL 2880980, at *6 (Tenn. Ct. App. July 3, 2019) (observing that the Board is not limited in its action to the specific circumstances listed in subsections (b)(1)-(22) because Tenn. Code Ann. § 63-6-214(b) states: "The grounds upon which the board shall exercise power, include, but are not limited to") (emphasis in original).

Disciplinary actions against physicians for allegedly prescribing and dispensing unsuitable medications or inappropriate amounts of medications typically involve grounds listed in Tenn. Code Ann. § 63-6-214(b)(1), (4), and (12), respectively:

(1) Unprofessional, dishonorable or unethical conduct;

(4) Gross health care liability or a pattern of continued or repeated health care liability, ignorance, negligence or incompetence in the course of medical practice; and

(12) Dispensing, prescribing or otherwise distributing any controlled substance or any other drug not in the course of professional practice, or not in good faith to relieve pain and suffering, or not to cure an ailment, physical infirmity or disease, or in amounts and/or for durations not medically necessary, advisable or justified for a diagnosed condition.

See, e.g., Johnson v. Tenn. Bd. of Med. Exam'rs., M2002-00048-COA-R3-CV, 2003 WL 1442413 (Tenn. Ct. App. Mar. 19, 2003) (physician disciplined under §§ 63-6-214(b)(1) and (4) for "unorthodox" hydrogen peroxide treatment for skin condition); Williams v. State Dep't of Health and Env't, 880 S.W.2d 955 (Tenn. Ct. App. 1994) (physician disciplined under § 63-6-214(b)(12) for prescribing large amounts of inappropriate drugs for patients with obesity problems); see also Rich v. Tenn. Bd. of Med. Exam'rs, 350 S.W.3d 919 (Tenn. 2011) (remand to Board for failing to articulate the applicable standard of care in proceeding brought under §§ 63-6-214(b)(1), (4) and (12) for physician's administration of chelation therapy, intravenous hydrogen peroxide therapy, and the use of methadone to treat patients suffering from opioid dependency).

Thus, by specifying these three grounds for disciplinary action, Tenn. Code Ann. § 63-6-214(b) allows for disciplinary proceedings against physicians who prescribe a medication, such as ivermectin or hydroxychloroquine, for "off-label" use in the treatment of COVID-19. "Off-label" use of a medication refers to a circumstance in which a patient uses a prescribed drug in a manner that varies in some way from the Federal Drug Administration-approved labeling of the drug. Richardson v. Miller, 44 S.W.3d 1, 9 (Tenn. Ct. App. 2000) (citations omitted).

Off-label use of an FDA-approved drug is not prohibited by the FDA, Association of Am. Physicians & Surgeons v. United States Food and Drug Admin., 13 F.4th 531, 534 (6th Cir. 2021), nor are decisions made by physicians regarding off-label use subject to the broad authority of the FDA over prescription drugs, id.; Richardson, 44 S.W.3d at 12-13; see 21 U.S.C. § 396. But a physician must still exercise his or her medical judgment and discretion in accordance with the applicable standard of care when prescribing a medication for off-label use. See Rich, 350 S.W.3d at 926-29; Johnson, 2003 WL 1442413, at 8. Consequently, whether the decision to prescribe a medication for off-label use to treat a particular patient for COVID-19 falls below the applicable standard of care might subject the physician to disciplinary action would depend on the totality of the relevant facts and circumstances in any given case. See Richardson, 44 S.W.3d at 20 ("Physicians may be found negligent if their decision to use a drug off-label is sufficiently careless, imprudent or unprofessional."); see, e.g., Johnson, 2003 WL 1442413, at 5, *8 (court disciplined physician for the "dangerous" intravenous administration of hydrogen peroxide, which was not an FDA-approved use of hydrogen peroxide).

However, effective November 21, 2021, the Board may not conduct a disciplinary action against a physician who prescribes a medication for off-label use in the treatment of COVID-19 unless and until the Board complies with Tenn. Code Ann. § 14-4-104, which provides that, "[n]otwithstanding title 63 or 68 to the contrary, any disciplinary process, or action taken pursuant to such process, that is implemented by a health-related board regarding the dispensing or prescribing of medication for COVID-19 must be promulgated as a rule pursuant to title 4, chapter 5."

In sum, while the Board is typically not required to promulgate a rule before conducting a disciplinary proceeding, Tenn. Code Ann. § 14-4-104 unequivocally requires the Board to promulgate a rule in accordance with title 4, chapter 5 of the Tennessee Code before it conducts any disciplinary proceeding "regarding the dispensing or prescribing of medication for COVID-19."

HERBERT H. SLATERY III
Attorney General and Reporter

ANDRÉE SOPHIA BLUMSTEIN
Solicitor General

LAURA T. KIDWELL
Assistant Solicitor General

Requested by:
The Honorable Kerry Roberts
State Senator
425 Rep. John Lewis Way N.
Suite 730 Cordell Hull Building
Nashville, Tennessee 37243

The Honorable John Ragan
State Representative
425 Rep. John Lewis Way N.
Suite 614 Cordell Hull Building
Nashville, Tennessee 37243