Municipal Certificate of Need (Muni-CON): An Overview
The TAG was chaired by Raphael M. Barishansky with the following SEMSCO members participating on the TAG: John J. Clair, Robert Delagi, Donald Faeth, Bill Huffner, MD, Alan Lewis, William Liddle, and from DOH Staff: Lee Burns, Dana Jonas
Table of Contents
Section I. Overview
- Explanation of the Muni-CON and historical perspective
- Application for the Municipal CON
- Important Points in the Muni-CON process
- What Municipalities seeking to operate ambulance or first-response services need to document prior to declaring municipal authority for ambulance services
Section IV. Appendixes and/or additional information
- NYS DOH Policy Statement 09-01 Municipal CON Applications
- NYS DOH Policy Statement 06-06 EMS Operating Certificate Application Process (CON)
- NYS Public Health Law Article 30 - Sections 3008 and 3005
- Part 800 - New York State Emergency Medical Services Code
This document, prepared at the behest of the EMS Systems subcommittee of the New York State EMS Council (SEMSCO), shall serve as an educational and informational tool to those entities that wish to learn more about the Municipal Certificate of Need process in New York State.
Traditionally, in order for an EMS service to gain operating authority , New York State Public Health Law Article 30 requires that the service make application to the local Regional EMS Council(s) in the proposed area(s) of operation, bear the burden of demonstrating that the definition of public need has been met at a public hearing, obtain a positive determination of public need from the Regional Council and successfully pass a fitness and competency review by the NY State Department of Health (DOH) prior to receiving a certificate of operating authority from the DOH.
A Municipal Certificate of Need, herein after referred to as a Muni-CON, was originally enacted in 1995 by the New York State Legislature to supercede the statutory process as a result of a municipality's desire to operate a municipal ambulance service. The municipality planned to task its Bureau of Fire to provide ambulance service within its boundaries. The municipality was unable to obtain Regional council approval and, as a result, the Legislature passed a State Law that created a municipal ambulance service for the City.
In 1996, the Legislature recognized that there were a significant number of municipalities in the State of New York with issues similar to the municipality referenced above and amended NYS PHL Article 30, creating municipal authority for any municipality to operate an ambulance service. Subsequent to this, the NYS DOH BEMS promulgated policy and procedure (originally Policy Statement 97-01 and subsequently Policy Statement 01-06) for Municipal CONs.
Certificate of Need (CON) is a process defined in NY State Public Health Law Article 30, section 3005, whereby an entity wishing to operate an ambulance service makes application to its local Regional EMS Council (REMSCO) for a determination of public need, prior to NYS DOH BEMS granting of a certificate of operating authority
- "The demonstrated absence, reduced availability or an inadequate level of care in ambulance or emergency medical service available to a geographic area which is not readily correctable through the reallocation or improvement of existing resources"
A "municipality" is defined by Article 1 of the New York State General Municipal Law as:
- "A county, town, city or village OR a fire district acting with the authority of or on behalf of such a municipality"
A "municipal governing body" is defined by Article 1 of the NY State General Municipal Law. It identifies a "Municipal Corporation" as a county, town, city, or village under the control of a governing board of such organizations, including a board of supervisors of a county, the town board of a town, the common council of a city, and the board of a trustees of a village.
"Primary Area of Operating Authority" is defined by Article 30 of the New York State Public Health Law as:
- "…the geographic area or subdivisions listed on an ambulance service certificate or statement of registration within which the ambulance service may receive patients for transport".
"Ambulance Service" is defined by Article 30 of the New York State Public Health Law as:
- "an individual, partnership, association, corporation, municipality or any legal or public entity or subdivision thereof engaged in providing emergency medical care and transportation of sick or injured persons by motor vehicle, aircraft or other forms of transportation to, from, or between hospitals or other health care facilities".
"Advanced Life Support First Response Service" or "ALS-FR" is defined by Article 30 of the New York State Public Health Law as:
- "an organization that provides advanced level support care but does not transport patients"
NY State Public Health Law (NYSPHL) Article 30, section 3008 (7-a) states that
- "…subject to the provisions of this article, any municipality within this state, or fire district acting on behalf of any such municipality, and acting through its local legislative body, is hereby authorized and empowered to adopt and amend local laws, ordinances or resolutions to establish and operate advanced life support first responder services or municipal ambulance services within the municipality, upon meeting or exceeding all standards set by the department for appropriate training, staffing and equipment, and upon filing with the New York State Emergency Medical Services Council, a written request for such authorization. Upon such filing, such municipal advanced life support first responder service or municipal ambulance service shall be deemed to have satisfied any and all requirements for determination public need for the establishment of additional emergency medical services pursuant to this article for a period of two years following the date of such filing. Nothing in this article shall be deemed to exclude the municipal advanced life support first responder service or municipal ambulance service authorized to be established and operated pursuant to this article from complying with any other requirement or provision of this article or any other applicable provision of law."
NY State Department of Health - Bureau of EMS (NYSDOH-BEMS) Policy Statement 09-01 Municipal Certificate of Need Applications details the required steps for municipalities seeking to establish an Ambulance Service (ALS or BLS) or Advanced Life Support First Response Service (ALS-FR). The municipality may establish its own Ambulance or ALS-FR Service, and then may elect to operate it or contract with a certified Ambulance or ALS-FR Service to operate the service. This does not absolve the municipality of legal responsibility for the provision of EMS service. Appropriate steps must be taken to ensure that the municipality has the required authorization from its governing authority to establish an Ambulance or ALS-FR Service. A local law, ordinance or resolution from the municipal governing authority for the requested service must include a statement of need, effective date of the authority, the geographic area to be served (the municipal boundaries) and the date the service will begin operations. Said municipality should be ready to operate, or contract, for the service when it files its request with the NYS DOH BEMS, on behalf of SEMSCO - as the 2 year certification period begins upon receipt of the municipality's filing the notice with the BEMS.
Current NY State statute allows municipalities to establish and operate Ambulance or ALS-FR Services prior to a determination of public need by a Regional EMS Council, but that does not absolve the municipality, from complying with all applicable statutes, rules and regulations for operating such a service, as the certificate is in the name of the municipality
Regardless of affiliation or governance, Ambulance and ALS-FR Services must operate within the boundaries of a formal regional EMS system and certified pre-hospital providers (CFR, EMT-Basic, EMT-Intermediate, EMT-Critical Care and EMT-Paramedic), must be duly credentialed and authorized to provide pre-hospital emergency medical care under the general supervision of a Regional Emergency Medical Advisory Committee (REMAC). NYSDOH-BEMS requirements for training, staff, equipment, quality improvement and administrative and medical oversight for Ambulance or ALS-FR Services are documented in Public Health Law, Article 30, Emergency Medical Services, and the New York Compilation of Codes, Rules and Regulations (NYCCRR) Part 800 The NY State Emergency Medical Services Code, which can be found in the appendices section of this document. If the new service wishes to carry and administer controlled substances, the service must obtain a Class C Dispensing License and comply with the rules and procedures found in NYCRR Part 80 Controlled Substances, which can be found in the appendices section of this document.
Once the aforementioned statutory and regulatory requirements for operating an Ambulance or ALS-FR Service are met and evidence of such compliance is reviewed during the NYSDOH-BEMS full-service on-site inspection, the municipality will be granted a certificate to operate an Ambulance or ALS-FR Service for a period of two (2) years from the date the request by the municipality was filed with the BEMS.
The municipality should submit its application to the appropriate REMSCO(s) sufficiently prior to the expiration of its initial two (2) year period to insure adequate opportunity for the REMSCO(s) to process, review, conduct a public hearing and make a determination of public need, thereby insuring continuity of operating authority without lapse.
NYS DOH-BEMS Policy Statement 06-06, Policy For Determining the Need for New or Expanding EMS Services In Accordance With PHL Article 30, which can be found in the appendices section of this document, formally defines the process.
The formal application process includes the:
- Completion of a detailed Application for New EMS Service form DOH-3777 as well as accompanying documentation and data.
- Successful completion of a fitness and competency review and associated Affirmation of Competency and Fitness form DOH-3778; and the
- Provision of Public Notices and Participation in Regional Public Hearings
- "…In the case of an application for certification pursuant to this subdivision, for a municipal advanced life support or municipal ambulance service, to serve the area within the municipality, where the proposed service meets or exceeds the appropriate training, staffing and equipment standards, there shall be a strong presumption in favor of approving the application."
While it is stated in the statute that "...there shall be a strong presumption in favor of approving the application.", it is still incumbent upon the municipality to establish that the creation and operation of its EMS authority has met a specific need by its population while maintaining compliance with all applicable, pre-established regulatory requirements. It is recommended that this be done by documenting the actual operation and geography served by the Ambulance / ALSFR since the start of the service.
Regional EMS Councils have been provided guidance and instructions by BEMS regarding the legislative intent supporting Section 3008 (7b), the strong presumption in favor of approving the application. The two year period of proper operation of the service supports the determination of need.
Such documentation should include but not be limited to:
- Number and type of emergency medical requests responded to
- Statements of need and/or support from served population groups, hospitals, specialty care facilities and nursing / elder care homes
- Mutual aid requests responded to in support of the local EMS system
- Statements of ongoing participation status in local/regional/state MCI, Homeland Security and other emergency medical response plans
- Evidence of continued compliance with Regional eligibility criteria and credentialing of personnel to provide ALS / Defibrillation level of care
- Evidence of continued compliance with applicable state and federal regulations including quality assurance and reporting requirements
- Documentation of meeting or exceeding staffing standards for all personnel providing patient care or providing medical oversight
The Regional EMS Council application and approval process must be completed prior to the expiration of the service's initial ambulance service operating certificate.
Once the application is complete, the NYSDOH-BEMS issues a finding for the fitness and competency of the municipality to operate an Ambulance or ALS-FR Service, and it is determined that the definition of public need has been met, and the municipality meets statutory and regulatory requirements for operating such a service, then NYSDOH-BEMS will issue the new operating certificate. If the application is denied, the municipality retains the right to appeal the decision. The appeal process includes assignment to a NY State Administrative Law Judge (ALJ) for process review and finding of facts, and subsequent review and recommendation by the NY State EMS Council (SEMSCO). The SEMSCO may uphold the ALJ decision, remand the issue back to the REMSCO for further review, or overrule the REMSCO decision.
Important Points in the Muni-CON process
- The request for a Muni-CON, including a request and documentation of authority from the governing authority must be sent directly to the New York State Department of Health Bureau of EMS (acting for SEMSCO) via certified mail or another form of return receipt delivery.
- If the municipality intends to provide Advanced Life Support (ALS) level of care, concurrent approval must be obtained in writing from the appropriate Regional Emergency Medical Advisory Committee (REMAC). Such approval shall document the municipality having met established criteria to provide ALS and state the specific level of ALS care authorized.
- Municipalities establishing an ALSFR must provide evidence of a written agreement with an ambulance service, with operating authority within the geography served, that insures the transport to an appropriate Article 28 facility (hospital or other health care facility) for each patient contact.
- The municipality, not the contracted service provider, is responsible for EMS service and overall compliance with applicable laws and regulations.
- The Municipal CON is valid for two years from the date of the original filing date with the SEMSCO.
- Prior to the expiration date of the ambulance service operating certificate , the municipality must file a complete Certificate of Need application for the specific type of service (ALS FR or Ambulance) with the appropriate Regional EMS Council, as outlined in PHL Article 30, Section 3008 - and NYS DOH Policy Statement 06-06. It is strongly recommended that the service be in communication with the REMSCO and that the application be filed at least ninety (90) days prior to the expiration of the original certificate to insure continuity of operating authority without lapse.
It is recommended that municipalities document statistical information pertaining to the performance of their local EMS system both before and after establishing municipal EMS authority. This information will be useful to managers of the service and REMSCOs, enabling them to adequately evaluate the new service's performance and enhance the service's complete and formal application to the REMSCO. This information should include the following:
- Total number of ambulance calls in your municipality in the previous 12 months. Show break down by emergency, transport, and standby?
- Average response time of the agencies involved for emergency calls (time of call until an EMS unit arrived on scene)?
- Total number of calls that went unanswered and had to be turned over to another EMS service/Mutual Aid?
- Funding of current agency? Is it funded by 100% voluntary contributions, a contract with your municipality, tax supported or by third party billing?
- How will the establishment of a new entity be funded and to what extent will it affect the financial structure of your municipality?
- How are you going to provide service with the new entity? Will you purchase equipment such as ambulance as well as additional equipment necessary to provide care at the level you are applying for? Will your municipality be contracting with a proprietary service or the existing service to provide service?
- Considering the commitment of funds involved to establish a new service would it be more economically feasible to work with the existing agencies in your municipality in assisting them to provide adequate service? This assistance could be provided in a variety of ways - such as, providing finances to assist in recruiting more personnel, hire personnel to provide coverage during the problem times, etc.
- List the services already operating in the municipality proposed
- Identify your mutual aid plan
- Identify your communications and dispatch policies & procedures
- Provide your transport agreements (if First Response Service)
- Identify treatment protocols and document REMAC approval (if ALS)
- List the number and types of vehicles
- Document compliance with NYCRR Part 800.
- Document compliance with Quality Improvement requirements (this includes an actual plan and any Regional participation)
- Identify medical direction and quality assurance resources.
- Examine the effect of establishing a new service on the existing EMS system and the surrounding communities.
Appendixes that should be included with this document.