Current through Register Vol. 46, No. 52, December 24, 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.
