Medical Use of Marihuana - Physician Assistants

NY-ADR

11/30/16 N.Y. St. Reg. HLT-48-16-00008-P
NEW YORK STATE REGISTER
VOLUME XXXVIII, ISSUE 48
November 30, 2016
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
PROPOSED RULE MAKING
NO HEARING(S) SCHEDULED
 
I.D No. HLT-48-16-00008-P
Medical Use of Marihuana - Physician Assistants
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of sections 94.2(e)(6) and 1004.1(a)(2) of Title 10 NYCRR.
Statutory authority:
Public Health Law, sections 3701 and 3369-a
Subject:
Medical Use of Marihuana - Physician Assistants.
Purpose:
To authorize physician assistants to register with DOH in order to issue certifications to patients with qualifying conditions.
Text of proposed rule:
Pursuant to the authority vested in the Commissioner of Health by Section 3701 of the Public Health Law (PHL), Section 94.2 of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York is hereby amended, and in accordance with section 3369-a of the PHL, subdivision 1004.1(a)(2) of Title 10 is amended, to be effective upon publication of a Notice of Adoption in the New York State Register, to read as follows:
§ 94.2 Supervision and scope of duties.
(e) Prescriptions, certifications and medical orders may be issued by a licensed physician assistant as provided in this subdivision when assigned by the supervising physician:
* * *
(6) A licensed physician assistant, in good faith and acting within his or her lawful scope of practice, and to the extent assigned by his or her supervising physician, may register as a practitioner under Part 1004 of this Title to issue patient certifications for medical marihuana, to those patients under the care of such supervising physician.
* * *
§ 1004.1 Practitioner registration.
(a) No practitioner shall be authorized to issue a patient certification as set forth in section 1004.2 unless the practitioner:
* * *
(2) is licensed, in good standing as a physician and practicing medicine, as defined in article 131 of the Education Law, in New York State, or is certified, in good standing as a nurse practitioner and practicing, as defined in article 139 of the Education Law, in New York State, or is licensed, in good standing as a physician assistant and practicing in New York State, as defined in article 131-B of the Education Law, under the supervision of a physician registered under this Part;
Text of proposed rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: [email protected]
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
This rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.
Regulatory Impact Statement
Statutory Authority:
The Commissioner of Health is authorized pursuant to section 3369-a of the Public Health Law (PHL) to promulgate rules and regulations necessary to effectuate the provisions of Title V-A of article 33 of the PHL. The Commissioner of Health is also authorized pursuant to section 3701 of the PHL to promulgate regulations defining and restricting the duties which may be assigned to physician assistants by their supervising physician, the degree of supervision required and the manner in which such duties may be performed.
Legislative Objectives:
The legislative objective of Title V-A is to comprehensively regulate the manufacture, sale and use of medical marihuana, by striking a balance between potentially relieving the pain and suffering of those individuals with serious medical conditions, as defined in section 3360(7) of the Public Health Law, and protecting the public against risks to its health and safety.
Needs and Benefits:
The regulatory amendments are necessary to allow physician assistants the ability to register with the Department to issue certifications for medical marihuana to patients under the care of such physician responsible for the physician assistant’s supervision. Allowing physician assistants to certify patients to use medical marihuana will increase access to medical marihuana, benefiting patients suffering from one or more of the severe, debilitating or life threatening conditions enumerated in section 3360(7) of the Public Health Law. This regulatory amendment will particularly benefit those patients in rural counties where there are fewer physicians available to certify patients for medical marihuana.
Costs:
Costs to the Regulated Entity:
Physician assistants who are interested in registering with the Department and whose supervising physician is already registered with the Department to certify patients to use medical marihuana, will need to take a Department-approved medical use of marihuana course. Currently, the cost to take the required course is $249.
Costs to Local Government:
This amendment to the regulation does not require local governments to perform any additional tasks; therefore, it is not anticipated to have an adverse fiscal impact.
Costs to the Department of Health:
With the authorization of physician assistants, additional practitioner registrations will need to be processed by the Department. In addition, the Department anticipates an increase in the number of patients certified to use medical marihuana. Depending upon the number of physician assistants who are interested in registering with the Department, this regulatory amendment may result in an increased cost to the Department for additional staffing to provide registration and certification support. However, any resulting cost of additional staffing is greatly outweighed by the benefit to public health in offering increased access to an alternative treatment option for patients suffering from one of the qualifying serious conditions.
Local Government Mandates:
This amendment does not impose any new programs, services, duties or responsibilities on local government.
Paperwork:
Physician assistants who certify patients to use medical marihuana will be required to maintain a copy of the patient’s certification in the patient’s medical record.
Duplication:
No relevant rules or legal requirements of the Federal and State governments duplicate, overlap or conflict with this rule.
Alternatives:
The alternative would be to continue to limit the definition of “registered practitioner” solely to physicians and nurse practitioners.
Federal Standards:
Federal requirements do not include provisions for a medical marihuana program.
Compliance Schedule:
There is no compliance schedule imposed by these amendments, which shall be effective upon publication of a Notice of Adoption in the New York State Register.
Regulatory Flexibility Analysis
No regulatory flexibility analysis is required pursuant to section 202-b(3)(a) of the State Administrative Procedure Act. The proposed amendment does not impose an adverse economic impact on small businesses or local governments, and it does not impose reporting, record keeping or other compliance requirements on small businesses or local governments.
Cure Period:
Chapter 524 of the Laws of 2011 requires agencies to include a “cure period” or other opportunity for ameliorative action to prevent the imposition of penalties on the party or parties subject to enforcement under the proposed regulation. The regulatory amendment authorizing physician assistants is not a mandate imposed upon physician assistants. Hence, no cure period is necessary.
Rural Area Flexibility Analysis
A Rural Area Flexibility Analysis for these amendments is not being submitted because amendments will not impose any adverse impact or significant reporting, record keeping or other compliance requirements on public or private entities in rural areas. There are no other compliance costs imposed on public or private entities in rural areas as a result of the amendments.
Job Impact Statement
No job impact statement is required pursuant to section 201-a(2)(a) of the State Administrative Procedure Act. It is apparent, from the nature of the proposed amendment, that it will not have an adverse impact on jobs and employment opportunities.
End of Document