Regulatory oversight of emergency medical services occurs primarily at the state level based on the provision laid out in the Emergency Medical Services (EMS) Systems Act of 1973. Despite this fact various levels of regulation exist at various levels of government in order to address the needs of the overall system. In addition to governmental agencies, some nongovernmental entities have produced standards that have been adopted by many jurisdictions (federal and state), making them de facto parts of the regulatory structure, despite their lack of regulatory authority.

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  Discuss federal regulations that directly and indirectly impact EMS systems.

  
  
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  Discuss the states’ provision of EMS and give examples of different state EMS organizational systems.

  
  
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  Give examples of local, regional, state, and federal regulatory organizations that govern/oversee EMS systems.

  
  
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  Discuss how no governmental organizations influence regulation of EMS.

While the laws, regulations, and policies that regulate EMS within the United States flow from our federal government for EMS operations within our borders, some EMS agencies transport across these borders. International operations, such as fixed-wing aircraft EMS, must be aware of and in compliance with a variety of international laws and regulations. In particular, transport of controlled substances, licensing of providers, and operation of aircraft outside of the United States require particular attention. Any international EMS operation, including disaster relief, repatriation via commercial aircraft, and any cross-border ambulance transport should enquire about these issues prior to initiating operations.

The history of federally regulated EMS in the United States dates from the 1960s, when physicians returning from the Vietnam War noted differences between military medicine and civilian EMS. In 1966, the Institute of Medicine published Accidental Death and Disability, the Neglected Disease of Modern Society, also known as the EMS White Paper.¹ This report argued effectively that the lack of civilian EMS and trauma care was leading to many avoidable disabilities and deaths. Congress followed by funding regional EMS system development in 1973 with addition of the Emergency Medical Services (EMS) Systems Act of 1973 (42 U.S.C. 300d) to the Public Health Service Act. This empowering legislation provided funding for states to establish EMS systems. Subsequent funding, including specific funding for EMS for children efforts, has aided in ­further development and regulation of EMS in the United States.

In addition, specific federal legislation, such as that regulating transfer of patients between facilities, reimbursement of healthcare providers, release of medical information, control of pathogens, and other topics are of particular importance to EMS. While not an inclusive list, the outline below describes in brief several federal agencies and other organizations that act at a national level to regulate EMS in the United States.

DOT NHTSA EMS

The Department of Transportation, National Highway Traffic Safety Administration, EMS Division, or DOT NHTSA EMS is the federal home for EMS in the United States.² NHTSA is the origin of a variety of educational and funding initiatives, including the EMS Agenda for the Future, the National Scope of Practice Model, and National EMS Core Content. Their office acknowledges a variety of other federal agencies that are involved in leadership for a comprehensive national EMS system, ranging from the Office of Rural Health Policy to the Centers for Disease Control and Prevention. (SeeBox 22-1.) NHTSA EMS provides coordinating leadership and funding that substantially controls the curriculum for EMT training in the United States, the scope of practice generally accepted for EMTs at various levels, and interstate coordination and cooperation of EMS systems.

DEA

The US Drug Enforcement Administration (DEA)³ is a branch of the US Department of Justice, and enforces the laws and regulations of the United States relating to controlled substances. When EMS agencies use controlled substances, such as narcotics and benzodiazepines, they must comply with DEA regulations. Typically, this involves a physician medical director or physician acting with similar authority who prescribes or orders these controlled substances for the ambulance service, and then a series of policies and procedures, which provide control over access to use of and inventory of these drugs. Failure to properly comply with these regulations and/or discovery of drug diversion may constitute ­significant legal and regulatory concern for the involved physician.

FAA

The Federal Aviation Administration (FAA) is the federal agency that controls the operation of aircraft and the licensing of aircrew in the United States. Therefore, it is involved in helicopter and fixed-wing aircraft EMS operations.⁴ While operation of an aircraft and EMS medical care may seem like clearly distinct areas, there is overlap and controversy. It appears that the FAA is attempting to clarify that its authority is limited to operation of the aircraft and the qualifications of the crew, and that the medical system determines whether there is need for patient transport by aircraft. However, controversies include decisions about federal versus state regulatory authority, the safety of medical helicopter operations, and the aviation qualifications of medical flight crew.⁵ For example, does the FAA or a state EMS agency have the authority to control whether a helicopter ambulance can respond to certain types of patient problems, where it can land, and what equipment and capabilities are available in the patient compartment? Are the medical crew, often EMTs and/or nurses, subject to FAA aircrew regulations, including duty work hours and drug testing? These and other controversies are currently under ­discussion (2011).

GSA

The US General Services Administration (GSA), among many other activities, offers minimum requirements to meet federal specifications for patient transport ambulances.⁶ These specifications, known as KKK-1822, are updated every 5 years, and are currently in revision F.⁷ As can be seen in Box 22-2, the GSA specifications refer to a number of laws and specifications from other agencies and organizations. In addition, the National Fire Protection Administration (NFPA) has developed a standard for ambulance construction as well. This standard, NFPA 1917, went into effect in 2012 and will likely be merged with the KKK ­specifications in the future.⁸