Current through Register Vol. 46, No. 12, March 20, 2024
(a)
Requirements for Patient
Certification. A practitioner who is registered pursuant to 1004.1 of
this part may issue a certification for the use of an approved medical marihuana
product by a qualifying patient subject to completion of subdivision (e) of this
section. Such certification shall contain:
(1)
the practitioner's name, business address, telephone number and email
address;
(2) the practitioner's
license number as issued by the New York State Department of Education;
(3) the practitioner's drug enforcement
administration registration number;
(4) a statement that the practitioner is
licensed and in good standing in New York State and possesses an active
registration with the drug enforcement administration;
(5) a statement that the practitioner is
registered with the department to issue the certification;
(6) a statement that the practitioner is caring
for the patient in relation to the patient's serious condition;
(7) the patient's name, date of birth, address,
telephone number and email address if available;
(8) the patient's diagnosis, limited solely to
the specific severe debilitating or life-threatening condition(s) listed below;
(i) cancer;
(ii) positive status for human immunodeficiency
virus or acquired immune deficiency syndrome, provided that the practitioner has
obtained from the patient consent for disclosure of this information that meets
the requirements set forth in sections
2780 and
2782 of the Public Health Law;
(iii) amyotrophic lateral sclerosis;
(iv) Parkinson's disease;
(v) multiple sclerosis;
(vi) damage to the nervous tissue of the spinal
cord with objective neurological indication of intractable spasticity;
(vii) epilepsy;
(viii) inflammatory bowel disease;
(ix) neuropathies;
(x) Huntington's disease;
(xi) any severe debilitating pain that the
practitioner determines degrades health and functional capability; where the
patient has contraindications, has experienced intolerable side effects, or has
experienced failure of one or more previously tried therapeutic options; and
where there is documented medical evidence of such pain having lasted three
months or more beyond onset, or the practitioner reasonably anticipates such pain
to last three months or more beyond onset;
(xii)
post-traumatic stress
disorder;
(xiii) pain that
degrades health and functional capability where the use of medical marihuana is
an alternative to opioid use, provided that the precise underlying condition is
expressly stated on the patient's certification; or
(xiv) substance use disorder; or
(xv) any other condition added by the
commissioner.
(9) The
condition or symptom that is clinically associated with, or is a complication of
the severe debilitating or life-threatening condition listed in paragraph (8) of
this subdivision. Clinically associated conditions, symptoms or complications, as
defined in subdivision seven of section thirty-three hundred sixty of the public
health law are limited solely to:
(i) Cachexia
or wasting syndrome;
(ii) severe or
chronic pain resulting in substantial limitation of function;
(iii) severe nausea;
(iv) seizures;
(v) severe or persistent muscle
spasms;
(vi) post-traumatic stress
disorder;
(vii) opioid use disorder;
or
(viii) such other conditions,
symptoms or complications as added by the commissioner.
(10) a statement that by training or
experience, the practitioner is qualified to treat the serious condition, which
encompasses the severe debilitating or life-threatening condition listed pursuant
to paragraph (8) of this subdivision and the clinically associated condition,
symptom or complication listed pursuant to paragraph (9) of this subdivision;
(i) for purposes of this subdivision, a
practitioner must hold a federal Drug Addiction Treatment Act of 2000 (DATA 2000)
waiver to be qualified to treat patients with substance use disorder or opioid
use disorder.
(11) a
statement that in the practitioner's professional opinion and review of past
treatments, the patient is likely to receive therapeutic or palliative benefit
from the primary or adjunctive treatment with medical marihuana for the serious
condition;
(12) any recommendations
or limitations the practitioner makes to the certified patient and/or the
patient's designated caregiver concerning:
(i)
the authorized brand, authorized form, administration method, dosage and any
limitations in the use of the approved medical marihuana product; and
(ii) the total amount of usable approved
medical marihuana product that may be dispensed to the patient, in measurable
controlled doses, which shall not exceed a 30 day supply, if used as
directed;
(13) a statement
that the practitioner has explained the potential risks and benefits of the use
of medical marihuana to the qualifying patient and has documented in the
patient's medical record that such explanation has been provided to the
patient;
(14) to the extent that a
practitioner is seeking to authorize the use of an approved medical marihuana
product by a patient who is under the age of 18 or a person who is otherwise
incapable of consenting to medical treatment, the practitioner shall explain the
potential risks and benefits of medical marihuana to the patient's parent or
legal guardian, and if appropriate, to the minor patient. The practitioner shall
document in the patient's medical record that such explanation has been provided
as required herein; and
(15) a
statement that the patient, or the patient's parent or legal guardian if
applicable, has provided informed consent; and.
(16) to the extent that a practitioner seeks to
authorize the use of an approved medical marihuana product by a patient who
temporarily resides in New York State for the purpose of receiving care and
treatment from the practitioner, the practitioner shall so state on the patient's
certification.
(b)
Expiration of certification.
(1)
The certification shall state the date upon which the certification shall expire,
which shall be no longer than one year after the date it was issued, unless the
patient is terminally ill.
(2) If the
practitioner issues a certification to a patient who is terminally ill, the
certification shall not expire until the patient's death or the practitioner
revokes the certification.
(3) If the
practitioner issues a certification to a patient who is not a resident of New
York but is receiving care and treatment in this state, the certification shall
be valid for a period of time which is no longer than the applicant is reasonably
anticipated to be residing in New York State for the purposes of care and
treatment, but in no event shall it be valid for more than one year after the
date it was issued.
(c)
Submission of certification to the department.
Practitioners shall utilize a form, which may be in an
electronic format, developed by the department for the certification required in
subdivision (a) of this section. The practitioner shall submit to the department,
the information required by subdivision (a) of this section, in a manner
determined by the department, including by electronic transmission through a
secure website. In the instance that a practitioner submits this information to
the department electronically, the practitioner shall retain, for a period of
five years, a printed copy of the electronic certification that shall contain the
information required in subdivision (a) of this section.
(d)
Medical record retention.
The practitioner shall date and place his or her handwritten
signature upon the printed certification, and provide the printed certification
to the patient. The practitioner shall also maintain a copy of the signed
certification in the patient's medical record.
(e)
Consultation of Prescription
Monitoring Program Registry. Prior to issuing, modifying or renewing a
certification, the practitioner shall consult the prescription monitoring program
registry pursuant to section
3343-a of the Public Health Law for the
purpose of reviewing a patient's controlled substance history. Practitioners may
authorize a designee to consult the prescription monitoring program registry on
their behalf, provided that such designation is in accordance with section
3343-a of the Public Health
Law.