HLT-30-15-00008-P Controlled Substances for EMS Agency Agent and Requirements for an Advanced Life Support System

7/29/15 N.Y. St. Reg. HLT-30-15-00008-P

NEW YORK STATE REGISTER

VOLUME XXXVII, ISSUE 30

July 29, 2015

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-30-15-00008-P

Controlled Substances for EMS Agency Agent and Requirements for an Advanced Life Support System

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed Action:

Amendment of sections 80.136 and 800.5 of Title 10 NYCRR.

Statutory authority:

Public Health Law, section 3002

Subject:

Controlled Substances for EMS Agency Agent and Requirements for an Advanced Life Support System.

Purpose:

To amend the regulations regarding the EMS Agency Agent and the Requirements for an Advanced Life Support System.

Text of proposed rule:

Paragraph (2) of subdivision (e) of section 80.136 of Part 80 is amended to read as follows:

(2) The Department shall issue such registration unless the Department finds that the application should be denied by reason of false statements in the application, [conviction of a felony,] failure to provide adequate safeguards against diversion of the controlled substances, [any conviction related to controlled substances, or] other good and sufficient reason such as an administrative determination that article 30 or 33 of the Public Health Law [or any provision within Part 800 of this Title or any provision within this Part] was violated, or that the applicant has been convicted of one or more criminal offenses, as defined in § 800.3(ak), unless the applicant is found eligible after a balancing of the factors set out in Article 23-A of the Correction Law. In accordance with that Article, no application for registration shall be denied by reason of the applicant having been previously convicted of one or more criminal offenses unless (i) there is a direct relationship between one or more of the previous criminal offenses and duties required of the registration or (ii) registering the applicant would involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these questions, the department will look at all factors listed under New York State Correction Law Section 753.

Section 800.5 of Part 800 is amended to read as follows:

800.5 Requirements For An Advanced Life Support System

(a) An advanced life support system must meet the following requirements:

(1) designation of a qualified physician to provide medical supervision and direction;

(2) integration with a hospital emergency service, or intensive care, coronary care, or other appropriate hospital unit.

(b) An ambulance or advanced life support first response service, when providing advanced life support services, must meet the requirements of Sections 800.23 and 800.24 of this Part and utilize a treatment record provided by or approved by the department, including submission of such record for use in quality assurance programs.

(c) An advanced life support system providing prehospital [intermediate] Advanced EMT care must include the following:

(1) voice communications to receive medical direction;

(2) equipment and supplies to provide prehospital [intermediate] advanced care; and

(3) staffing by a certified advanced emergency medical technician [intermediate], emergency medical technician-critical care, or emergency medical technician-paramedic, as appropriate.

(d) An advanced life support system providing prehospital EMT- critical care and/or EMT-paramedic services must include the following:

(1) voice communications to receive medical direction;

(2) biomedical telemetry;

(3) equipment and supplies to provide pre-hospital critical care and/or EMT-paramedic services; [and]

(4) hold a current license, in accordance with Article 33 of the Public Health Law and Title 10 NYCRR Part 80.136, unless exempt as an ALS agency owned and operated by a hospital, to obtain, possess and administer controlled substance medications to treat patients in accordance with applicable State-approved regional protocols; and

[(4)] (5) staffing by a certified emergency medical technician-critical care or emergency medical technician-paramedic, as appropriate.

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, [phone], email: [e-mail]

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 authority for the promulgation of this regulation is contained in Public Health Law (PHL) Article 30 (Emergency Medical Services), Section 3002, as well as Article 33 (Controlled Substances), Sections 3308 and 3390. Section 3002 sets forth the provisions creating the New York State Emergency Medical Services Council (SEMSCO) and specifies that it shall have the power, by an affirmative vote of a majority of those present, subject to approval by the Commissioner, to enact, and from time to time, amend and repeal, rules and regulations establishing minimum standards for ambulance services, ambulance service certification, advanced life support first response services, the provision of prehospital emergency medical care, public education, the development of a statewide emergency medical services system, the provision of ambulance services outside of the primary territory specified in the ambulance services’ certificate and the training, examination, and certification of certified first responders, emergency medical technicians, and advanced emergency medical technicians; provided, however that such minimum standards must be consistent with the staffing standards established by the ambulance services and advanced life support first response services provisions outlined in PHL Section 3005-a.

PHL 3308 authorizes the Commissioner to promulgate regulations which are necessary and proper to supplement the provisions of Article 33 to effectuate its purposes and intent.

Additionally, PHL 3390 authorizes the Commissioner to revoke a license or certificate issued under Article 33 in whole or in part upon a finding that the licensee or certificate holder has been convicted in any jurisdiction relating to a substance listed as a controlled substance in Article 33.

Legislative Objectives:

The purpose of PHL Article 30 is to promote the public health, safety and welfare by providing certification for pre-hospital care providers and all advanced life support first response and ambulance services. The purpose of PHL Article 33 is to prevent the illegal use of and trade in controlled substances and to provide for the legitimate use of controlled substances in health care.

Needs and Benefits:

The revisions to Section 800.5 add a requirement that Advanced Life Support (ALS) agencies providing Critical Care and/or Paramedic level service must be licensed, in accordance with PHL Article 33 and Title 10 NYCRR Part 80.136, to obtain, stock and administer controlled substance medications as per state approved regional protocols. The State Emergency Medical Advisory Committee (SEMAC), the advisory board to the Commissioner of Health, and the SEMSCO have recognized that the ability to provide a patient with controlled substance medications when indicated is the national standard for ALS prehospital emergency medical care. At present, there are 675 ALS EMS agencies in New York State. Of the 675 ALS EMS agencies, 522 already hold current controlled substances licenses under PHL Article 33. This revision will currently affect the remaining 153 agencies and any newly established advanced life support level EMS agency. Agencies that do not seek licensure to obtain stock and administer controlled substances in accordance with PHL Article 33 Section 800.5 would be authorized to apply for and provide care only at the Advanced EMT level, which would allow their patients the benefit of advanced airway management and some medication for emergency treatment for diabetics and allergies, but no advanced medication therapy.

An ALS EMS agency’s ability to administer controlled substance medication to patients during prehospital emergency care is of significant benefit to the patient. Controlled substance medications may be used to treat seizures, medical anxiety, profound agitation and excited delirium, as well as pain prior to arrival at a hospital.

For example, prehospital medical protocols to allow ALS providers to use benzodiazepines for seizure management have been a mainstay of EMS care in much of the State for many years. Indeed, when the National Association of EMS Physicians first examined prehospital care standards in 2008, they carefully considered the ability to provide timely treatment of seizures. (Evidence Based Performance Measures for EMS Systems, Prehospital Emergency Care, 2008;12:141-51.) Patients experiencing prolonged or continuous seizures -- seizures that do not stop rapidly on their own -- can develop subtle brain damage; brain damage that may have been prevented by administration of a benzodiazepine such as midazolam or diazepam. In addition, management of seizures in the field makes transportation safer for both the patient and the EMS providers.

Furthermore, on January 14, 2015, the SEMAC and SEMSCO authorized an update to the EMS protocols for the City of New York to recommend access to the benzodiazepine (midazolam) for the treatment of patients with excited delirium. Excited delirium is a condition that manifests as a combination of delirium, psychomotor agitation, anxiety, hallucinations, speech disturbances, disorientation, violent and bizarre behavior, insensitivity to pain, elevated body temperature, and superhuman strength. Excited delirium can result in sudden death (usually via cardiac or respiratory arrest) when the patient is subjected to physical control measures, including police restraint. ("White Paper Report on Excited Delirium Syndrome", ACEP Excited Delirium Task Force, American College of Emergency Physicians, September 10, 2009). Rapid chemical sedation of patients with excited delirium may prevent such outcomes and would allow EMS to assist law enforcement effectively in the care of people in crisis.

Pain management is the standard of care for patients suffering acute traumatic injury. (ATLS 9th Ed.) Early treatment of pain improves care in the emergency department and reduces the need for higher doses of medication. The Joint Commission: Accreditation, Healthcare, Certification (Joint Commission) has made early administration of pain medication a goal of its hospital surveys and prehospital pain management reduces the time to emergency department analgesia significantly. Also, for patients suffering heart attacks, early pain management reduces the oxygen demand on the heart and may reduce long-term damage and morbidity. (Circulation 12/13/05, vol 112, no 24, p IV-98 for reduction of oxygen demand.)

Critical care technicians and paramedics train to use complex medications as a part of the delivery of care. The agencies and the medical directors authorizing these providers to afford patient care must have access to controlled substances to provide necessary medical therapy to best protect the health of their patients.

The proposed regulation also amends section 80.136 of Part 80 related to the issuance of certifications to agents of advanced life support agencies. Section 80.136 is updated to incorporate Correction Law Article 23-A’s balancing test when reviewing applications to register an agent to purchase, possess, and deliver controlled substances, and specifies that the factors set forth in Correction Law § 753 will be utilized when making a determination whether to grant the application to an applicant who has a criminal conviction.

Costs for the Implementation of and Continuing Compliance with these Regulations to the Regulated Entity:

There is a fee of $100 for the original application and each renewal thereafter. Municipally owned EMS agencies are exempt from the application fee. Affected EMS agencies will be required to purchase the controlled substance medications and develop a method of securing them in the vehicles and the base of operations as required by Title 10 NYCRR Part 80.136. This cost will vary depending on the cost of the medications and the locking system chosen by the EMS agency.

Cost to State and Local Government:

There will be no costs to the general public, state and local government. These regulations are directed at the advanced life support level EMS agency. An EMS agency that is part of state or local municipal government is exempted by regulation from the application fee.

Cost to the Department of Health:

The Department of Health will not incur any additional costs.

Local Government Mandates:

These provisions do not add any additional mandates to local governments.

Paperwork:

Affected EMS agencies will need to apply for a Controlled Substance license through the Department of Health.

Duplication:

This measure does not duplicate, overlap or conflict with a State or federal statute or rule.

Alternatives:

There are no other viable alternative approaches. Current provisions must be updated to reflect appropriate EMS standards and practice.

Federal Standards:

This regulatory amendment does not exceed any minimum standards of the federal government for the same or similar subject areas. This proposal is intended to update Part 800 provisions with language appropriate and applicable to the modern EMS system.

Compliance Schedule:

This proposal will go into effect upon publication of the Notice of Adoption in the New York State Register.

Regulatory Flexibility Analysis

A Regulatory Flexibility Analysis for Small Business and Local Governments is not included in accordance with Section 202-b of the State Administrative Procedure Act (SAPA). This regulation does not impose an adverse economic impact, nor reporting, recordkeeping or other compliance requirements on small businesses or local governments. This rule pertains only to individual persons who are certified by the Department to provide pre-hospital emergency care and treatment to sick or injured persons. Small businesses and local governments cannot violate this rule, and therefore cannot be subject to penalties associated with a violation of this rule.

Cure Period

A cure period was not included in this rule. This proposal would provide standards for EMS providers. Violations of such standards would pose a threat to public health, safety and well-being of the patients served. A cure period would not be appropriate under these circumstances.

Rural Area Flexibility Analysis

Pursuant to section 202-bb of the State Administrative Procedure Act (SAPA), a rural area flexibility analysis is not required. These provisions apply uniformly throughout New York State, including all rural areas.

The proposed rule will not impose an adverse economic impact on rural areas, nor will it impose any additional reporting, record keeping or other compliance requirements on public or private entities in rural areas.

Job Impact Statement

A Job Impact Statement is not included in accordance with Section 201-a (2) of the State Administrative Procedure Act (SAPA), because it will not have a substantial adverse effect on jobs and employment opportunities.