Current through Register Vol. 42, No. 11, August 30, 2024
(1) In
order to recommend a patient for the use of medical cannabis, a registered
certifying physician shall, within the scope of his or her usual medical
practice or specialty, diagnose a patient with at least one qualifying medical
condition or shall confirm, through personal, direct observation and assessment
and primary source verification, that the patient has been medically diagnosed,
by a physician, with at least one qualifying medical condition.
(2) A registered certifying physician shall
establish a bona fide physician-patient relationship with the patient for the
provision of medical services in an in-person visit that complies with this
Chapter and for which there is an expectation that the physician will provide
care to the patient on an ongoing basis.
(a)
Prior to certifying or recommending, or recertifying or re-recommending, a
patient for the use of medical cannabis, the registered certifying physician
shall have conducted a physical examination while physically present in the
same room as the patient and obtained a full assessment of the patient's
medical history. Any certification or recommendation, or recertification or
re-recommendation, of a patient for the use of medical cannabis must also occur
with the registered certifying physician and the qualified patient physically
present in the same room.
(3) A registered certifying physician shall
create and maintain a medical record that satisfies the provisions of Ala.
Admin Code R.
545-X-4-.09 and shall also
include, at a minimum, the following:
(a) The
patient's name and date or dates of office visits or treatments;
(b) A description of the patient's qualifying
medical condition;
(c) Documented
assessment of the patient's medical history, including relevant prescription
history and any history of substance use disorder;
(d) Documented review of any available
relevant diagnostic test results;
(e) Documented review of prior treatment and
the patient's response to the treatment;
(f) Documented review of the patient's
current medication to identify possible drug interactions, including all
controlled substances;
(g)
Documented review that conventional medical treatment or therapy has been
attempted;
(h) Prior to initially
certifying or recommending a patient for the use of medical cannabis, a
registered certifying physician shall obtain a drug screen on the patient for
the presence of controlled substances. A physician shall not certify or
recommend the use of medical cannabis for any patient who has a positive drug
screen for any illicit or controlled substances for which they are not
prescribed, excluding cannabis. The registered certifying physician shall
confirm any controlled substance prescriptions by querying the patient's PDMP
profile and shall consider the polypharmacy and possible interactions of these
substances with cannabis prior to certifying or recommending a patient for the
use of medical cannabis. Results of the drug screen shall be maintained in the
medical record;
(i) The registered
certifying physician's performance of a physical examination relevant to the
patient's current medical condition;
(j) Immediately prior to certifying or
recommending, or recertifying or re-recommending, a patient for the use of
medical cannabis, a registered certifying physician shall obtain a negative
pregnancy test result on any patient capable of conception. The results of the
pregnancy test shall be maintained in the medical record;
(k) The physician's diagnosis of the
patient's qualifying medical condition; and
(l) If the patient has been previously
diagnosed with a qualifying medical condition by another qualified physician,
the registered certifying physician may confirm the diagnosis provided that the
registered certifying physician obtains a copy of the medical records or a
detailed written summary indicating the diagnosis, and the registered
certifying physician is satisfied that he or she can rely on those records to
confirm diagnosis of a qualifying medical condition. The registered certifying
physician shall maintain a copy of any record or report of any other physician
on which the registered certifying physician relied for purposes of meeting the
requirements under this paragraph. The registered certifying physician shall
verify and document the diagnosing physician's continuing diagnosis of the
patient's qualifying medical condition prior to each recertification.
(4) If the registered certifying
physician diagnoses or confirms the diagnosis of a qualifying medical
condition, the physician shall document in the medical record compliance with
all of the following actions when certifying or recommending treatment with
medical cannabis:
(a) Development of a
treatment plan, including consideration of whether treatment with medical
marijuana is complementary to standard medical treatment.
(b) The review of the patient's controlled
drug prescription history in the PDMP. The review shall cover at least the
twenty-four (24) months immediately preceding the date of the certification or
recertification.
(c) Discussion
with the patient regarding any indicators of possible abuse or diversion of
controlled substances that are reflected on the PDMP report.
(d) The explanation of the risks and benefits
of treatment with medical cannabis as it pertains to the patient's qualifying
medical condition and medical history.
(e) The registered qualified patient's
voluntary and informed written consent prior to completing a certification or
recommendation for treatment with medical cannabis. If the patient is a minor,
the physician shall obtain the voluntary and informed written consent of the
patient's parent or legal guardian prior to completing a certification or
recommendation for treatment with medical cannabis for the patient. The
voluntary and informed written consent for all registered qualified patients
and/or legal guardians and, if applicable, registered caregivers shall be
memorialized on a form authorized by the Board, a copy of which shall also be
provided to the patient or legal guardian and, if applicable, registered
caregiver. The voluntary and informed written consent form shall, at a minimum,
include:
1. The federal and state
classification of cannabis as a Schedule I controlled substance.
2. The approval and oversight status of
cannabis by the Food and Drug Administration.
3. The current state of research on the
efficacy of cannabis to treat the qualifying medical condition or
conditions.
4. The potential for
addiction.
5. The potential effect
that cannabis may have on a patient's coordination, motor skills, and
cognition, including a warning against operating heavy machinery, operating a
motor vehicle, or engaging in activities that require an individual to be alert
or respond quickly.
6. The
potential side effects of cannabis use.
7. The risks, benefits, and drug interactions
of cannabis.
8. A statement that
the use of medical cannabis could result in termination from employment without
recourse and that costs may not be covered by insurance or government
programs.
9. That the patient's
de-identified health information contained in the patient's medical record,
physician certification, and patient registry may be used for research purposes
or used to monitor compliance with Code of Ala. 1975,
§§
20-2A-1, et. seq.
10. A statement that a certification or
recommendation by a registered qualifying physician does not constitute a
prescription for medical cannabis.
11. Whether the patient requires the use of a
registered caregiver to assist in the use or administration of medical
cannabis. If the patient requires or utilizes a registered caregiver, the
physician shall document the name of the registered caregiver designated by the
patient or the patient's legal representative. The registered caregiver must
also review and sign the voluntary and informed written consent form in the
presence of the registered certifying physician.
(5) In certifying or recommending
treatment with medical cannabis, a registered certifying physician or his or
her delegate shall determine from the patient registry whether the patient has
an active registration for the use of medical cannabis.
(a) If the patient is not registered or if
the patient's registration will expire within thirty (30) days, the registered
certifying physician shall submit the patient's application for registration or
renewal to the patient registry.
(b) The electronic certification or
recommendation for treatment with medical cannabis that is submitted to the
patient registry shall include:
1. The
registered qualified patient's full legal name, date of birth, and social
security number;
2. The registered
qualifying physician's name and Alabama Medical Cannabis Certification Permit
number;
3. The full legal name,
date of birth, and social security number of the patient's registered parent or
legal guardian and/or registered caregiver, if applicable;
4. A description of the qualifying medical
condition(s) and indication whether the qualifying condition is a terminal
illness for which the registered qualified patient has a life expectancy of six
(6) months or less;
5. The daily
dosage of medical cannabis (as measured by potency of
delta-9-tetrahydrocannabinol) that the registered certifying physician is
recommending to the registered qualified patient. Any daily dosage recommended
by a registered certifying physician shall not exceed the limitations set forth
by the AMCC for each of the qualifying medical conditions;
6. The type or permissible form(s) of medical
cannabis that the registered certifying physician recommends;
7. The permissible length of duration of the
certification, which shall not exceed thirty days for a patient capable of
conception, or ninety (90) days for all other patients;
8. A statement from the registered certifying
physician certifying that a bona fide physician-patient relationship exists
between the registered certifying physician and registered qualified
patient;
9. A statement from the
registered certifying physician affirming that the registered qualified patient
has been diagnosed with at least one qualifying medical condition by either the
registered certifying physician or another qualified physician;
10. A statement from the registered
certifying physician that, prior to certifying the use of medical cannabis, he
or she has, or has confirmed through primary source verification of the
patient's medical records that another qualified physician has, attempted
conventional medical treatments or therapies for the patient's qualifying
medical condition, and that said conventional treatments and/or therapies have
failed to result in successful outcomes, or that current conventional medical
treatment indicates that the use of medical cannabis is the standard of care
for the patient's qualifying medical condition;
11. If the qualifying medical condition is
based upon a terminal illness as defined in this Chapter, a statement from the
registered qualifying physician that the patient is suffering from an illness
or physical condition which the registered qualifying physician professionally
and reasonably expects to result in the patient's death in six (6) months or
less after the date of the certification; provided, a registered certifying
physician shall not recertify a patient as having a terminal illness if the
patient has been certified as having a terminal illness for a period of
twenty-four (24) months or more;
12. An affirmation from the registered
certifying physician that he or she, or his or her delegate, has obtained from
the PDMP a report of information related to the registered qualified patient
that includes, at a minimum, the twenty-four (24) months immediately preceding
the date of the certification or recertification; and
13. An affirmation from the registered
certifying physician that he or she has informed the registered qualified
patient of the risks and benefits of medical cannabis as it pertains to the
patient's qualifying medical condition and medical history.
(c) Absent any extenuating
circumstances, a registered certifying physician shall, within twenty-four (24)
hours, input into the patient registry any certification, recertification, or
any updates thereto. Any deactivation shall be entered into the patient
registry immediately upon the registered certifying physician becoming aware of
the reason for the deactivation.
(6) A registered certifying physician who
certifies or recommends treatment with medical cannabis shall be available to
provide follow-up care and treatment to the patient, including physical
examinations relevant to the patient's condition to determine the efficacy of
medical cannabis in treating the patient's qualifying medical
condition.
(7) A registered
certifying physician shall deactivate a current certification or decline to
issue a new certification for medical cannabis under any of the following
circumstances:
(a) The registered qualified
patient no longer has the diagnosis of or symptoms of the qualifying medical
condition.
(b) The registered
certifying physician no longer possesses a valid Alabama Medical Cannabis
Certification Permit.
(c) Based on
the registered certifying physician's clinical judgment, the registered
qualified patient or registered caregiver is abusing or diverting medical
cannabis.
(d) The registered
qualified patient is deceased.
(8) The records required for the
certification or recommendation of medical cannabis may be kept with the
patient's other medical records and shall be retained for at least seven (7)
years in accordance with Ala. Admin. Code R.
540-X-9-.10.
Author: Alabama Board of Medical
Examiners
Statutory Authority:
Code of Ala.
1975, §§
34-24-53,
34-24-53.1; Act 2021-450
(Code of Ala. 1975, §§
20-2A-1, et. seq.)