Tenn. Comp. R. & Regs. 0880-02-.14 - SPECIALLY REGULATED AREAS AND ASPECTS OF MEDICAL PRACTICE
(1) Policy Statement - The scope of practice
of physicians in Tennessee is broadly defined and includes many aspects which
if not particularly regulated could lead to serious ramifications for the
consuming public. This Rule is to designate specific areas in the practice of
medicine for regulation the violation of which may result in disciplinary
action pursuant to either T.C.A. §§
63-6-214(b)(1) or
63-6-214(b)(4) or
63-6-214(b)(12).
(2) Pharmaceutical Dispensing - Physicians
who elect to dispense medication for remuneration must comply with the
following:
(a) All Federal Regulations ( 21
CFR 1304 through 1308) for the dispensing of controlled substances.
(b) Requirements for dispensing of
non-controlled drugs are as follows:
1. Drugs
are to be dispensed in an appropriate container labeled with at least, the
following:
(i) Patient's name.
(ii) Date.
(iii) Complete directions for
usage.
(iv) The physician's name
and address.
(v) A unique number,
or the name and strength of the medication.
2. Physicians may dispense only to
individuals with whom they have established a physician/patient relationship.
It shall be a violation of this rule for a physician to dispense medication at
the order of any other physician not registered to practice at the same
location.
3. Whenever dispensing
takes place, appropriate records shall be maintained. A separate log must be
maintained for controlled substances dispensing.
(c) It is not the intention of this Rule to
interfere with the individual physician's appropriate use of professional
samples, nor to interfere in any way with the physician's right to directly
administer drugs or medicines to any patient.
(d) Dispensing or prescribing controlled
substances in amounts or for durations not medically necessary, advisable or
justified is considered to be practicing beyond the scope of the professional
practice.
(3)
Amphetamines, Amphetamine-Like Substances, and Central Nervous System
Stimulants.
(a) It shall be a prima facie
violation of T.C.A. §§
63-6-214(b)(1)
and 63-6-214(b)(12)
to prescribe, order, administer, sell or otherwise distribute any amphetamine
drug except:
1. For treatment of the
following:
(i) attention deficit
disorder;
(ii) drug-induced brain
dysfunction;
(iii)
narcolepsy;
(iv) dementia or
organic brain syndrome with severe psychomotor retardation;
(v) Chronic depression refractory to other
drugs. Such diagnosis must be included on the prescription.
2. When the licensee has applied
for and received from the Board of Medical Examiners a written approval for the
clinical investigation of such drugs under a protocol satisfactory to the
Board. Any such approval by the Board of Medical Examiners will be filed with
the Board of Pharmacy and disseminated by the Board of Pharmacy to any pharmacy
which would fill prescriptions written during the research.
(b) The list of amphetamine drugs
governed by subparagraph (3)(a) of this Rule includes the following controlled
substances:
1. Amphetamine, its salts, optical
isomers and salts of its optical isomers; (examples are Biphetamine, Dexadrine,
Benzedrine and others).
2.
Methamphetamine, its salts, isomers and salts of isomers; (an example is
Desoxyn).
3. Any salt, any type of
isomer and salts of such isomers, or any chemical element or any mixture,
compound, material or preparation, containing any quantity of any of the
substances listed above or their salts, any type of isomers and salts of such
isomers, or chemical elements are also governed by this rule.
(c) It shall be a prima facie
violation of T.C.A. §§
63-6-214(b)(1)
and 63-6-214(b)(12)
to prescribe, order, administer, sell or otherwise distribute any
amphetamine-like substance listed below, except when the licensee has applied
for and received from the Board of Medical Examiners a written approval for the
clinical investigation of such drugs under a protocol satisfactory to the
Board. Any such approval by the Board of Medical Examiners will be filed with
the Board of Pharmacy and disseminated by the Board of Pharmacy to any pharmacy
which would fill prescriptions written during the research.
1. The list of amphetamine-like substances
governed by this rule are the following controlled substances:
(i) Phenmetrazine and its salts; (an example
is Preludin)
(ii) Benzphetamine;
(an example is Didrex)
(iii)
Chlorphentermine; (an example is Pre Sate)
(iv) Phendimetrazine; (examples are Plegine,
Bontril, Meltiat, Prelu-2, Adipost, Wehles, and others)
(v) Diethylproprion; (examples are Tenuate
and Tepanil)
(vi) Mazindol;
(examples are Mazandor and Sanorex)
(vii) Phentermine; (examples Ionamin, Fastin,
Adipex and others), except as authorized pursuant to T.C.A. §
63-6-214;
(viii) Fenfluramine HS; (an example
Pondimin), except as authorized pursuant to T.C.A. §
63-6-214.
2. Any salt, any type of isomer and salts of
such isomers, or any chemical element or any mixture, compound, material or
preparation, containing any quantity of any of the substances listed above or
their salts, any type of isomers and salts of such isomers, or chemical
elements, except as authorized pursuant to T.C.A. §
63-6-214, are also governed by
this rule.
(d) It shall
be a prima facie violation of T.C.A. §§
63-6-214(b)(1)
and 63-6-214(b)(12)
to prescribe, order, administer, sell or otherwise distribute any central
nervous system stimulant listed below except:
1. For treatment of any of the following:
(i) attention deficit disorder;
(ii) drug-induced brain
dysfunction;
(iii)
narcolepsy;
(iv) dementia or
organic brain syndrome with severe psychomotor retardation;
(v) Chronic depression refractory to other
drugs. Such diagnosis must be included on the prescription.
2. When the licensee has applied
for and received from the Board of Medical Examiners a written approval for the
clinical investigation of such drugs under a protocol satisfactory to the
Board. Any such approval by the Board of Medical Examiners will be filed with
the Board of Pharmacy and disseminated by the Board of Pharmacy to any pharmacy
which would fill prescriptions written during the research.
(e) The list of central nervous
system stimulants governed by subparagraph (3)(d) of this rule are the
following controlled substances:
1.
methylphenidate; (an example is Ritalin)
2. pemoline (including organometallic
complexes and chelates thereof; an example is Cylert)
3. Any salt, any type of isomer and salts of
such isomers, or any chemical element or any mixture, compound, material or
preparation, containing any quantity of any of the substances listed above or
their salts, any type of isomers and salts of such isomers, or chemical
elements are also governed by this rule.
(4) Prescription writing shall be governed by
Tennessee Code Annotated, Section
63-6-236 and Title 53, Chapter 10,
Part 2.
(5) Universal Precautions
For The Prevention Of HIV Transmission - The Board adopts, as if fully set out
herein, rules 1200-14-03-.01 through
1200-14-03-.03 inclusive, of the
Department of Health and as they may from time to time be amended, as its rule
governing the process for implementing universal precautions for the prevention
of HIV transmission for health care workers under its jurisdiction.
(6) Authority of Physician to Prescribe for
the Treatment of Pain - Purpose - The purpose of this chapter is to recognize
that some dangerous drugs and controlled substances are indispensable for the
treatment of pain, and are useful for relieving and controlling many other
related symptoms that patients may suffer. It is the position of the board that
these drugs may be prescribed for the treatment of pain and other related
symptoms after a reasonably based medical diagnosis has been made, in adequate
doses, and for appropriate lengths of time, which in some cases may be as long
as the pain or related symptoms persist. The board recognizes that pain,
including intractable pain, and many other related symptoms are subjective
complaints and that the appropriateness and the adequacy of drug and dose will
vary from individual to individual. The practitioner is expected to exercise
sound medical judgment in treating pain and related symptoms with dangerous
drugs and controlled substances.
(a)
Definitions. The following words and terms, as used in this rule shall have the
following meanings in the context of providing medications for pain and related
symptoms.
1. Abuser of narcotic drugs,
controlled substances and dangerous drugs - A person who takes a drug or drugs
for other than legitimate medical purposes.
2. Intractable pain - A pain state in which
the cause of the pain cannot be removed or otherwise treated and which in the
generally accepted course of medical practice no relief or cure of the cause of
the pain is possible or none has been found after reasonable efforts.
3. Non-therapeutic in nature or manner - A
medical use or purpose that is not legitimate.
4. Prescribing pharmaceuticals or practicing
consistent with the public health and welfare - Prescribing pharmaceuticals and
practicing medicine for a legitimate medical purpose in the usual course of
professional practice.
(b) No physician is required to provide
treatment to patients with intractable pain with opiate medications but when
refusing to do so shall inform the patient that there are physicians whose
primary practice is in the treatment of severe, chronic, intractable pain with
methods including the use of opiates. If the patient requests a referral to
such a physician, and the physician makes such a referral that referral shall
be noted in the patient's medical records.
(c) If a physician provides medical care for
persons with intractable pain, with or without the use of opiate medications,
to the extent that those patients become the focus of the physician's practice
the physician must be prepared to document specialized medical education in
pain management sufficient to bring the physician within the current standard
of care in that field which shall include education on the causes, different
and recommended modalities for treatment, chemical dependency and the
psycho/social aspects of severe, chronic intractable pain.
(d) The treatment of persons with an acute or
chronic painful medical condition who also require treatment for chemical
dependency by a physician shall be governed by T.C.A. §
63-6-1107(c) and
(d).
(e) Guidelines - The Tennessee Board of
Medical Examiners will use the following guidelines to determine whether a
physician's conduct violates T.C.A. §
63-6-214(b) (12) through
(14) in regard to the prescribing,
administering, ordering, or dispensing of pain medications and other drugs
necessary to address their side effects.
1.
The treatment of pain, including intractable pain, with dangerous drugs and
controlled substances is a legitimate medical purpose when done in the usual
course of professional practice.
2.
A physician or surgeon duly authorized to practice medicine in Tennessee and to
prescribe controlled substances and dangerous drugs in this state shall not be
subject to disciplinary action by the board for prescribing, ordering,
administering, or dispensing dangerous drugs or controlled substances for the
treatment and relief of pain, including intractable pain, in the usual course
of professional practice for a legitimate medical purpose in compliance with
applicable state and federal law.
3. Prescribing, ordering, administering, or
dispensing dangerous drugs or controlled substances for pain will be considered
to be for a legitimate medical purpose if based upon accepted scientific
knowledge of the treatment of pain, including intractable pain, not in
contravention of applicable state or federal law, and if prescribed, ordered,
administered, or dispensed in compliance with the following guidelines where
appropriate and as is necessary to meet the individual needs of the patient:
(i) After a documented medical history, which
may be provided orally or in writing by the patient, and physical examination
by the physician providing the medication including an assessment and
consideration of the pain, physical and psychological function, any history and
potential for substance abuse, coexisting diseases and conditions, and the
presence of a recognized medical indication for the use of a dangerous drug or
controlled substance;
(ii) Pursuant
to a written treatment plan tailored for the individual needs of the patient by
which treatment progress and success can be evaluated with stated objectives
such as pain relief and/or improved physical and psychosocial function. Such a
written treatment plan shall consider pertinent medical history and physical
examination as well as the need for further testing, consultations, referrals,
or use of other treatment modalities;
(iii) The physician should discuss the risks
and benefits of the use of controlled substances with the patient or
guardian;
(iv) Subject to
documented periodic review of the care by the physician at reasonable intervals
in view of the individual circumstances of the patient in regard to progress
toward reaching treatment objectives which takes into consideration the course
of medications prescribed, ordered, administered, or dispensed as well as any
new information about the etiology of the pain;
(v) Complete and accurate records of the care
provided as set forth in parts (i)-(iv) of this paragraph should be kept. When
controlled substances are prescribed, names, quantities prescribed, dosages,
and number of authorized refills of the drugs should be recorded, keeping in
mind that pain patients with a history of substance abuse or who live in an
environment posing a risk for medication misuse or diversion require special
consideration. Management of these patients may require closer monitoring by
the physician managing the pain and consultation with appropriate health care
professionals.
4. A
decision by a physician not to strictly adhere to the provisions of paragraph 3
of this section will, for good cause shown, be grounds for the board to take no
disciplinary action in regard to the physician. Each case of prescribing for
pain will be evaluated on an individual basis. The physician's conduct will be
evaluated to a great extent by the treatment outcome, taking into account
whether the drug used is medically and/or pharmacologically recognized to be
appropriate for the diagnosis, the patient's individual needs including any
improvement in functioning, and recognizing that some types of pain cannot be
completely relieved.
5. If the
provisions as set out in subparagraphs (1)-(4) of this section are met, and if
all drug treatment is properly documented, the board will consider such
practices as prescribing in a therapeutic manner, and prescribing and
practicing medicine in a manner consistent with public health and
welfare.
6. Quantity of
pharmaceutical and chronicity of prescribing will be evaluated on the basis of
the documented appropriate diagnosis and treatment of the recognized medical
indication, documented persistence of the recognized medical indication, and
properly documented follow-up evaluation with appropriate continuing care as
set out in this rule.
7. A
physician may use any number of treatment modalities for the treatment of pain,
including intractable pain, which are consistent with legitimate medical
purposes.
8. These rules shall not
be construed so as to apply to the treatment of acute pain with dangerous drugs
or controlled substances for purposes of short-term care.
(7) Prerequisites to Issuing
Prescriptions or Dispensing Medications - In Person, Electronically, and Over
the Internet
(a) Except as provided in
subparagraph (b), it shall be a prima facie violation of T.C.A. §
63-6-214(b) (1), (4), and
(12) for a physician to prescribe or dispense
any drug to any individual, whether in person or by electronic means or over
the Internet or over telephone lines, unless the physician, or his/her licensed
supervisee pursuant to appropriate protocols or medical orders, has first done
and appropriately documented, for the person to whom a prescription is to be
issued or drugs dispensed, all of the following:
1. Performed an appropriate history and
physical examination; and
2. Made a
diagnosis based upon the examinations and all diagnostic and laboratory tests
consistent with good medical care; and
3. Formulated a therapeutic plan, and
discussed it, along with the basis for it and the risks and benefits of various
treatments options, a part of which might be the prescription or dispensed
drug, with the patient; and
4.
Insured availability of the physician or coverage for the patient for
appropriate follow-up care.
(b) A physician, or his/her licensed
supervisee pursuant to appropriate protocols or medical orders, may prescribe
or dispense drugs for a person not in compliance with subparagraph (a)
consistent with sound medical practice, examples of which are as follows:
1. In admission orders for a newly
hospitalized patient; or
2. For a
patient of another physician for whom the prescriber is taking calls or for
whom the prescriber has verified the appropriateness of the medication;
or
3. For continuation medications
on a short-term basis for a new patient prior to the patient's first
appointment; or
4. For established
patients who, based on sound medical practices, the physician feels do not
require a new physical examination before issuing new prescriptions;
or
5. In compliance with paragraph
(9) of this rule.
(c) It
shall be a prima facie violation of T.C.A. §
63-6-214(b) (1), (4), and
(12) for a physician, or his/her licensed
supervisee pursuant to appropriate protocols or medical orders, to prescribe or
dispense any drug to any individual for whom the physician, or his/her licensed
supervisee pursuant to appropriate protocols or medical orders, has not
complied with the provisions of this rule based solely on answers to a set of
questions regardless of whether the prescription is issued directly to the
person or electronically over the Internet or telephone lines.
(8) Code of Ethics - The Board
adopts, as if fully set out herein and to the extent that it does not conflict
with state law, rules or Board Position Statements, as its code of medical
ethics the "Code of Medical Ethics" published by the A.M.A. Council on Ethical
and Judicial Affairs as it may, from time to time, be amended.
(a) In the case of a conflict the state law,
rules or position statements shall govern. Violation of the Board's code of
ethics shall be grounds for disciplinary action pursuant to T.C.A. §
63-6-214(b)
(1).
(b) A copy of the A.M.A. "Code of Medical
Ethics" may be obtained from the Order Department of the A.M.A. at 515 N. State
Street, Chicago, IL 60610 or by phone at 1-800-621-8335, or on the Internet at
http://www.ama-assn.org.
(9) Treatment of Chlamydia
trachomatis
(a) Purpose - This rule provides
an acceptable deviation from the normal standard of care in the treatment of
Chlamydia trachomatis (hereafter Ct) and provides a means for physicians to
help reduce Tennessee's rate of Ct infection which currently exceeds the
national rate by over ten percent (10%), and which, if left untreated, can
cause serious health problems including pelvic inflammatory disease, ectopic
pregnancies, infertility, cervical cancer and an increased risk of HIV
infection. This rule will allow physicians and those over whom they exercise
responsibility and control to provide an effective and safe treatment to the
partners of patients infected with Ct who for various reasons may not otherwise
receive appropriate treatment.
(b)
For purpose of this rule "partner(s)" shall mean any person who comes into
sexual contact with the infected patient during the sixty (60) days prior to
the onset of patient's symptoms or positive diagnostic test results.
(c) Prerequisites - Physicians and those who
provide medical services under their responsibility and control who have first
documented all of the following in the medical records for patients may provide
partner treatment pursuant to subparagraph (d) of this rule:
1. A laboratory-confirmed Ct infection
without evidence of co-infection with gonorrhea or other complications
suggestive of a relationship to Ct infection; and
2. Provision of treatment of the patient for
Ct; and
3. An attempt to persuade
the infected patient to have all partners evaluated and treated and the patient
indicated that partners would not comply; and
4. Provision of a copy of reproducible,
department-provided Ct educational fact sheet or substantially similar
Ct-related literature available from other professional sources to the patient
with copies for all partners; and
5. Counseling the patient on sexual
abstinence until seven (7) days after treatment and until seven (7) days after
partners have been treated; and
(d) Partner Treatment - Upon documentation in
the patient's medical records of all prerequisites in subparagraph (c)
physicians or those who provide medical services under their responsibility and
control may either:
1. Provide to the treated
patient non-named signed prescriptions for, or dispense to the patient, the
appropriate quantity and strength of azithromycin sufficient to provide
curative treatment for the total number of unnamed "partners" as defined in
subparagraph (b) and indicated by the patient.
2. Provide to the treated patient signed,
name-specific prescriptions for, or dispense to the patient, the appropriate
quantity and strength of azithromycin sufficient to provide curative treatment
for the total number of known partners as defined in subparagraph (b) and named
by the patient.
(10) Use of Laser Equipment - Any procedure
encompassed within the definition of the practice of medicine contained in
T.C.A. §
63-6-204 that is to be performed
by use of a laser shall be considered, except as provided in T.C.A.
§§
63-26-102(5) and
63-9-106, to be the practice of
medicine and any person performing such procedure must be under the supervision
of a licensed physician.
(11) Use
of Titles - Any person who possesses a valid, current and active license issued
by the Board that has not been suspended or revoked has the right to use the
title "Medical Doctor" or "M.D." and to practice medicine, as defined in T.C.A.
§§
63-6-204. Any person licensed by
the Board to whom this rule applies must use one of the titles authorized by
this rule in every "advertisement" [as that term is defined in rule
0880-02-.13(2)(a)
] he or she publishes or the failure to do so will constitute an omission of a
material fact which makes the advertisement misleading and deceptive and
subjects the physician to disciplinary action pursuant to T.C.A. §
63-6-214(b)(1), (b)(3), (b)(8) and
(b)(9).
(12) Any physician who, pursuant to T.C.A.
§
63-6-204(b), is
required to have control over and responsibility for medical services being
provided by any allied health professional regardless of where those services
are being provided must have an unencumbered license just as is currently
required for physicians who supervise physician assistants pursuant to rule
0880-02-.18(1)
and certified nurse practitioner prescription writers pursuant to rule
0880-06-.02(1).
(13) Medical certification on death
certificates - Any physician who is required to and refuses to or consistently
fails to comply with the provisions of T.C.A. §
68-3-502 regarding medical
certification on death certificates shall be subject to disciplinary action
pursuant to T.C.A. §
63-6-214(b)(1).
(14) Practice of Interventional Pain
Management as Defined and Restricted Pursuant to T.C.A. §
63-6-244
(a) For purposes of T.C.A. §
63-6-244(a)(2), a
recent graduate who is not yet eligible to sit for board-certification by one
of the boards listed in §
63-6-244(a)(1)
may engage in interventional pain management provided the recent graduate is in
a practice relationship with a supervising physician who does meet the
qualifications of §
63-6-244(a)(1),
as long as such practice relationship meets the following standards:
1. The recent graduate must be an employee,
associate or partner of the supervising physician;
2. During the first six months of the
practice relationship, the supervising physician must directly supervise the
non-eligible, recent graduate in the performance of at least twenty-four (24)
interventional pain management procedures; and
3. The supervising physician shall make a
personal review of no less than 10% of the recent graduate's procedure notes/
charts on a quarterly basis and shall so certify by signature on the
chart.
(b) The exemption
provided under T.C.A. §
63-6-244(a)(2)
and this rule for a recent graduate not yet eligible for board certification
expires five years from the date of completion of the recent graduate's
post-graduate medical training, at which time the non-eligible recent graduate
must cease and desist such practice if board-certification pursuant to T.C.A.
§
63-6-244(a)(1)
has not been achieved and such practice may not be re-instituted until such
board-certification is achieved.
(c) For purposes of T.C.A. §
63-6-244(a)(3), a
physician who is board-certified in a different ABMS or ABPS/ AAPS specialty
than those listed in (a)(1) may practice interventional pain management upon
successful completion of an ACGME pain fellowship or becoming board-certified
through the American Board of Interventional Pain Physicians.
(15) For purposes of T.C.A. §
53-11-311 regarding use of
buprenorphine products and in order to qualify as an "addiction specialist", a
physician must meet one of the following definitions:
(a) A physician licensed by the Tennessee
Board of Medical Examiners or the Tennessee Board of Osteopathic Examination
who is certified by the American Board of Addiction Medicine (ABAM), or is
certified in addiction medicine by the American Osteopathic Association or is
subspecialty certified by the American Board of Psychiatry and Neurology (ABPN)
in addiction psychiatry or has completed the residency and fellowship
requirements for same and is in the board certification process; or
(b) A physician licensed by the Tennessee
Board of Medical Examiners or the Tennessee Board of Osteopathic Examination
who has a primary ABMS (American Board of Medical Specialties) or AOA (American
Osteopathic Association) board certification and at least three (3) years of
full-time equivalent experience treating patients with a primary substance
abuse disorder while the physician is employed by or practicing in a facility
that is licensed by the Tennessee Department of Mental Health and Substance
Abuse Services or in a facility of equivalent licensure in another state. At
least six (6) months full-time equivalent of that experience must be gained
while caring for patients who are receiving care in licensed Alcohol and Drug
Residential Detoxification Treatment facilities, as defined in
0940-05-44-.01 or Alcohol and
Drug Residential Rehabilitation Treatment facilities, as defined in
0940-05-45-.01, or their
equivalent in other states.
Notes
Authority: T.C.A. §§ 4-5-202, 4-5-204, 53-11-311, 63-1-145, 63-6-101, 63-6-204, 63-6-214, 63-6-244, and 68-3-502.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.