Tenn. Comp. R. & Regs. 1050-02-.13 - SPECIFICALLY REGULATED AREAS AND ASPECTS OF MEDICAL PRACTICE
(1) The scope of practice of osteopathic
physicians in Tennessee is broadly defined in the Osteopathic Medical Act and
promulgated rules 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 osteopathic medicine for regulation
the violation of which may result in disciplinary action pursuant to T.C.A.
§
63-9-111.
(2) Pharmaceutical Dispensing - Osteopathic
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 the 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)
Prescription writing shall be governed by Tennessee Code Annotated, §
63-9-116 and
Title 53, Chapter 10, Part 2.
(4)
Supervision - See rule
1050-02-.15
The Utilization and Supervision of a Certified Nurse Practitioner or Licensed
Physician Assistant.
(5) Guidelines
for the Use of Controlled Substances for the Treatment of Pain -
(a) Purposes and Intent
1. The Board recognizes that principles of
quality medical practice dictate that the people of the State of Tennessee have
access to appropriate and effective pain relief. The appropriate application of
up-to-date knowledge and treatment modalities can serve to improve the quality
of life for those patients who suffer from pain as well as reduce the morbidity
and costs associated with untreated or inappropriately treated pain. The Board
encourages physicians to view effective pain management as a part of quality
medical practice for all patients with pain, acute or chronic, and it is
especially important for patients who experience pain as a result of terminal
illness. All physicians should become knowledgeable about effective methods of
pain treatment as well as statutory requirements for prescribing controlled
substances.
2. Inadequate pain
control may result from physicians' lack of knowledge about pain management or
an inadequate understanding of addiction. Fears of investigation or sanction by
federal, state and local regulatory agencies may also result in inappropriate
or inadequate treatment of chronic pain patients. Accordingly, these guidelines
have been developed pursuant to the Tennessee Intractable Pain Treatment Act to
clarify the Board's position on pain control, specifically as related to the
use of controlled substances, to alleviate physician uncertainty and to
encourage better pain management.
3. The Board recognizes that controlled
substances, including opioid analgesics, may be essential in the treatment of
acute pain due to trauma or surgery and chronic pain, whether due to cancer or
non-cancer origins. Physicians are referred to the U.S. Agency for Health Care
and Research Clinical Practice Guidelines for a sound approach to the
management of acute and cancer-related pain. The medical management of pain
should be based on current knowledge and research and include the use of both
pharmacologic and non-pharmacologic modalities. Pain should be assessed and
treated promptly, and the quantity and frequency of doses should be adjusted
according to the intensity and duration of the pain. Physicians should
recognize that tolerance and physical dependence are normal consequences of
sustained use of opioid analgesics and are not synonymous with
addiction.
4. The Board is
obligated under the laws of the State of Tennessee to protect the public health
and safety. The Board recognizes that inappropriate prescribing of controlled
substances, including opioid analgesics, may lead to drug diversion and abuse
by individuals who seek them for other than legitimate medical use. Physicians
should be diligent in preventing the diversion of drugs for illegitimate
purposes.
5. Physicians should not
fear disciplinary action from the Board for prescribing, dispensing or
administering controlled substances, including opioid analgesics, for a
legitimate medical purpose and in the usual course of professional practice.
The Board will consider prescribing, ordering, administering or dispensing
controlled substances for pain to be for a legitimate medical purpose if based
on accepted scientific knowledge of the treatment of pain or if based on sound
clinical grounds. All such prescribing must be based on clear documentation of
unrelieved pain and in compliance with applicable state and federal
law.
6. Each case of prescribing
for pain will be evaluated on an individual basis. The board will not take
disciplinary action against a physician for failing to adhere strictly to the
provisions of these guidelines, if good cause is shown for such deviation. 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.
7. The Board will judge the validity of
prescribing based on the physician's treatment of the patient and on available
documentation, rather than on the quantity and chronicity of prescribing. The
goal is to control the patient's pain for its duration while effectively
addressing other aspects of the patient's functioning, including physical,
psychological, social and work-related factors. The following guidelines are
not intended to define complete or best practice, but rather to communicate
what the Board considers to be within the boundaries of professional
practice.
(b) Guidelines
- The Board adopts the following guidelines when evaluating the use of
controlled substances for pain control:
1.
Evaluation of the Patient - A complete medical history and physical examination
must be conducted and documented in the medical record. The medical record
should document the nature and intensity of the pain, current and past
treatments for pain, underlying or coexisting diseases or conditions, the
effect of the pain on physical and psychological function, and history of
substance abuse. The medical record also should document the presence of one or
more recognized medical indications for the use of a controlled
substance.
2. Treatment Plan - The
written treatment plan should state objectives that will be used to determine
treatment success, such as pain relief and improved physical and psychosocial
function, and should indicate if any further diagnostic evaluations or other
treatments are planned. After treatment begins, the physician should adjust
drug therapy to the individual medical needs of each patient. Other treatment
modalities or a rehabilitation program may be necessary depending on the
etiology of the pain and the extent to which the pain is associated with
physical and psychosocial impairment.
3. Informed Consent and Agreement for
Treatment - The physician should discuss the risks and benefits of the use of
controlled substances with the patient, persons designated by the patient or
with the patient's surrogate or guardian if the patient is incompetent. The
patient should receive prescriptions from one physician and one pharmacy where
possible.
4. Periodic Review - At
reasonable intervals based on the individual circumstances of the patient, the
physician should review the course of treatment and any new information about
the etiology of the pain. Continuation or modification of therapy should depend
on the physician's evaluation of progress toward stated treatment objectives,
such as improvement in patient's pain intensity and improved physical and/or
psychosocial function, i.e., ability to work, need of health care resources,
activities of daily living and quality of social life. If treatment goals are
not being achieved, despite medication adjustments, the physician should
reevaluate the appropriateness of continued treatment. The physician should
monitor patient compliance in medication usage and related treatment
plans.
5. Consultation - The
physician should be willing to refer the patient as necessary for additional
evaluation and treatment in order to achieve treatment objectives. The
management of pain in patients with a comorbid psychiatric disorder may require
extra care, monitoring, documentation and consultation with or referral to an
expert in the management of such patients.
6. Medical Records - The physician should
keep accurate and complete records to include the medical history and physical
examination; diagnostic, therapeutic and laboratory results; evaluations and
consultations; treatment objectives; discussion of risks and benefits;
treatments; medications (including date, type, dosage and quantity prescribed);
instructions and agreements; and periodic reviews. Records should remain
current and be maintained in an accessible manner and readily available for
review.
(c) 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.
(d) 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.
(e) 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
subsections T.C.A. §
63-6-1107(c) and
(d).
(6) 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. §
63-9-111(b)(1),
(4), and (11) 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) in
circumstances 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. §
63-9-111(b)(1),
(4), and (11) 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.
(7) Amphetamines,
Amphetamine-Like Substances, and Central Nervous System Stimulants.
(a) It shall be a prima facie violation of
T.C.A. §§
63-9-111(b)(1)
and
63-9-111(b)(11)
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 Osteopathic Examination a written approval
for the clinical investigation of such drugs under a protocol satisfactory to
the Board. Any such approval by the Board of Osteopathic Examination 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 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. §§
63-9-111(b)(1)
and
63-9-111(b)(11)
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 Osteopathic Examination a written approval
for the clinical investigation of such drugs under a protocol satisfactory to
the Board. Any such approval by the Board of Osteopathic Examination 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, dipost, Wehles, and others)
(v) Diethylproprion; (examples are Tenuate
and Tepanil)
(vi) Mazindol;
(examples are Mazandor and Sanorex)
(vii) Phentermine; (examples are Ionamin,
Fastin, Adipex and others), except as authorized pursuant to T.C.A. §
63-6-214;
(viii) Fenfluramine HS; (an example is
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. §§
63-9-111(b)(1)
and
63-9-111(b)(11)
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 Osteopathic Examination a written approval
for the clinical investigation of such drugs under a protocol satisfactory to
the Board. Any such approval by the Board of Osteopathic Examination 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 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.
(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 Ethics" published by the A.O.A. 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. §
63-9-111(b)(1).
(b) A copy of the A.O.A. "Code of Ethics" may
be obtained from the American Osteopathic Association, 142 E. Ontario Street,
Chicago, IL 60611 or by phone at (312) 202-8138.
(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 osteopathic medicine
contained in T.C.A. §
63-9-106
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
63-6-204,
to be the practice of osteopathic medicine.
(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 titles "Osteopathic Physician,"
"Osteopathic Physician and Surgeon," "Doctor of Osteopathic Medicine," "Doctor
of Osteopathy," or "D.O." and to practice osteopathic medicine, as defined in
T.C.A. § 63-9106. 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
1050-02-.11(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. §
63-9-111(b)(1),
(b)(3), (b)(10) and (b)(19).
(12) Practice of Interventional Pain
Management as Defined and Restricted Pursuant to T.C.A. §
63-9-121.
(a) For purposes of T.C.A. §
63-9-121(a)(2),
a recent graduate who is not yet eligible to sit for board-certification by one
of the boards listed in §
63-9-121(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 §
63-9-121(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, 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 procedures notes/charts on a quarterly basis and shall so certify by
signature on the chart.
(b) The exemption provided under T.C.A.
§
63-9-121(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.
§
63-9-121(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. §
63-9-121(a)(3),
a physician who is board-certified in a different AOA, 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.
(13) 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 one of these specialties 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 an aggregate of 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 an aggregate of 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, 53-10-201, et seq., 63-1-145, 63-1-146, 63-9-101, 63-9-106, 639-109, 63-9-111, 63-9-116, and 63-9-121.
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