EMS Federal Regulations

Issues of Concern

Traditionally, the source of Federal funding and oversight comes from the Office of EMS under the National Highway Traffic Safety (NHTSA), which is part of the United States Department of Transportation (DOT). This structure came from EMS's development in response to the 1960's "white paper" entitled "Accidental Death and Disability," which was a landmark paper addressing traumatic injuries as a national healthcare issue.[1][2][3] The Highway Safety Act established EMS in the DOT. NHTSA also directed the development of the National Education Standards Curricula, developed model EMS State legislation, and provided funding to States to develop State EMS Offices.

Clinical Significance

Funding

Public Law 93-154 EMS Systems Act (EMSSA) enacted by Congress in 1973 supported within the Department of Health, Education, and Welfare (DHEW) under the Division of EMS [42 U.S.C. 300d]. It was a grant program to enable the development of regional emergency and trauma systems. It also created the first 70-hour EMT training course. It was the first to list fifteen key components curricula:

• Personnel
• Training
• Communication
• Transport
• Emergency Facilities
• Critical care units
• Public safety agency
• Consumer participation
• Public teaching/education
• System review/evaluation
• Standard record keeping
• Access to care
• Patient transfer
• Disaster planning
• Mutual aid

More than 300 EMS regions across the US received federal funding. However, it did not stimulate financing at the local level to continue the growth of EMS.[1][2][3]

In 1981, the Omnibus Budget Reconciliation Act changed principle funding for EMS from the feds to the states. States were given broad discretionary funding into preventive health block programs, virtually eliminating funding under the EMSS Act. Many states did not allocate any funding towards EMS, leading to a decline in EMS funding locally.[1][2] 

The Emergency Medical Treatment and Labor Act of 1986 [Federal Statute 42 USCS - 1395dd] was enacted to prevent patient "dumping" based on the inability to pay for services while CMS further defined the scope, modifying and clarifying guidelines.[4]

Financial

The Centers for Medicare & Medicaid Services also play a significant role in EMS regulation as they determine what services and reimbursement rates Medicare and Medicaid will pay. In addition to many EMS patients' primary source of insurance, CMS has an outsized role in determining payments as many private insurers base their reimbursements on CMS standards [Title 42 CFR § 410.40 Coverage of Ambulance Services]. CMS also requires all ground ambulances to be staffed by at least two providers who meet the requirements of their state certifications. CMS has also updated its reimbursement coding procedures. HIPAA [65 FR 50312 – Health Insurance Reform Standards for Electronic Transactions] required coding.[1][4]

Children

The Emergency Medical Services for Children Program Act was authorized by Congress in 1984 to allow federal funding [Public Law 98-555]. EMSC Program is under the Department of Health and Human Services, Health Resources, and Services Administration, and Maternal and Child Health Bureau. The intention is to reduce the morbidity and mortality of pediatric illness and injury by supporting improvements in the quality of emergency care. Legislators reauthorized it in 2018 [S.3482 - Emergency Medical Services for Children Program Reauthorization Act of 2018]. Five targeted issues grants received funding to address the gaps further and enhance programs in pediatric emergency care. The funding also helped support the first pediatric devoted research network, PECARN (Pediatric Emergency Care Applied Research Network), and encouraging partnerships and collaborations, develop model products.[1][5]

Equipment 

The Public Health Services Act was amended by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). It governs laboratory testing, including point of care testing [42 USC 263a]. CLIA, also under CMS's regulatory purview, prohibits Medicare or Medicaid funding to those laboratories that are not certified. The Food & Drug Administration established three categories of lab testing based on CLIA regulations, including high complexity, moderate complexity, and waived. Waivers exist for specific laboratory analyses, including glucometers used in the EMS setting. The EMS Agency must apply for a CLIA waiver to use Point-of-Care testing. All providers using the equipment must be trained, demonstrate competency, perform quality controls, and maintain records. 

[29 CFR 1910.7 Definition and Requirements for a Nationally Recognized Testing Laboratory]

[21 CFR 820 Quality System Regulation]

Controlled Substance

Federal law also significantly addresses controlled substances, both through legislation and regulations. The primary federal agency for this subject area is the Drug Enforcement Administration (DEA).

The Controlled Substances Act of 1970 [21 USC 823] regulated substances with abuse potential, but did not include instructions for EMS. The Protecting Patient Access to Emergency Medications Act 2017 approved the use of standing orders (if allowed by the state), DEA registration, maintenance, and administration of controlled substances, and EMS Agency liability. EMS Agencies must register with both DEA and state authorities. There must be a DEA registration for each address where controlled substances are stored.[6] The recommendation was that the medical director for an agency that uses controlled substances maintain a separate DEA other than their clinical DEA. 

Patient Information

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (Title XXVII) governs the electronic transmission of patient records and the privacy of patient records. It is an Amendment to the Public Health Service Act [42 U.S.C.] The Department of Health and Human Services (DHHS) has the primary responsibility for the implementation and enforcement of HIPAA. Any healthcare operation that shares private health information is mandated to comply. EMS agencies are required to have a Compliance Officer and train their staff. 

Workforce Safety 

All EMS employees have the right to a safe workplace that is free from recognized hazards that could cause harm or death [29 CFR 1910.11200 Hazard Communications]. The Federal Department of Labor's Regulatory Agency, Occupational Safety and Health Administration (OSHA), provides and enforces standards in workforce safety. States can apply their own OSHA regulations and standards. The Federal OSHA does not cover emergency response public sector employees. OSHA recommends the minimum training, safeguarding, and Personal Protective Equipment (PPE) for EMS standard [29 Code of Federal Regulations CFR 1910.120 HAZWOPER], [29 CFR 1910.134 Respiratory Protection Plan] [7]

[21 CFR 1910.1030 Bloodborne Pathogens] 

[29 CFR 1910.95 Occupational Noise Exposure]

Labor

The 1938 Fair Labor Standards Act (FLSA) created wage requirements and hour restriction for most employees. Further, in 2016, increase the minimum salary, pay overtime if hours worked are more than 40 in seven consecutive 24-hour periods; this includes all first responders. Exemptions from minimum wage and overtime include administrative, executive, professional, and sales [Final Rule 29 CFR Part 541 Defining and Delimiting the Exemptions for Executive, Administrative, Professional, Outside Sales and Computer Employees]. 

[Middle-Class Tax Relief and Job Creation Act of 2012]

Research

The Center for Disease Control (CDC) led the national efforts in all aspects of injury-related public health activities from prevention to rehabilitation after the Injury Prevention Act of 1990 and the Injury Control Act of 1990. It became a new injury research center. 

Pandemic and All-Hazards Preparedness

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 extends funds and improves several programs focusing on improving preparedness for a public health emergency and can temporarily reassign local personnel during a public health emergency. In 2019, the S. 1379 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 was passed. This new law contains many vital issues related to EMS, including the Good Samaritan Act, Mission Zero Act ensuring adequate training for response to pandemics, sufficient stockpiles of diagnostic and medical equipment, and vaccines.[8]

Trauma System Development

Trauma Care Systems and Planning Development Act of 1990 – enacted to improve both prehospital and trauma care. Title XII of the Public Health Service Act (PHSA) was a grant program to State EMS offices to improve prehospital trauma care, improve rural EMS care, optional activities such as research. The Division of Trauma and EMS was created in the Department of Health and Human Services.[9]

Communications

From call-receiving to Emergency Medical Dispatch, to communicate with each other, EMS relies on communication numbers (9-1-1, or seven-digit), and the variety of methods from VOIP, cell phone, radio systems, and so forth. The Federal Communications Commission (FCC) regulates telecommunications access and communications. All components have their federal and state regulations. 

9-1-1 Centers are the Point of Safety Answering Points (PSAPs) that is overseen by the Department of Justice. The FCC requires wireless service to transmit all 9-1-1 calls to the local Public Service Answering Points, in addition to licensing all state, regional, and tribal public safety radio systems.

The Wireless Communications and Public Safety Act of 1999 (911 Act) – to encourage a nationwide seamless communications infrastructure. The Act also directed the FCC to make 9-1-1 the universal emergency number for telephone services. The New and Emerging Technologies 911 Improvement Act of 2008 (NET 911 Act) requires the FCC to submit an annual report to Congress. Fees used for anything other than 9-1-1 services must be reported to Congress.[10][11]

[Wireless Communications and Public Safety Act of 1999] 

[Ensuring Needed Help Arrives Near Callers Employing 911 Act of 2004] [Enhance 911 Act of 2004]

Ground Ambulance Design

In 1972 the DOT requested the General Services Administration to develop standards for ambulances, and by 1974, the first Federal Specification for Star-of-Life Ambulances, KKK-A-1822, was published. The triple K-Specs’ purpose to define the minimum requirements for federally purchased ambulances. The most recent update was 2019, KKK-A-1822f. [12] Other agencies have also provided ambulance standards recommendations including National Fire Protection Agency (NFPA) and Commission on Accreditation of Ambulance Services (CAAS).  All set forth best practice recommendations PMID: [13]. The standards are not mandated for all ambulances.

[Under Title 49, Federal Motor Carrier Safety Regulations (NHTSA DOT): Transportation 49 CFR 393 Parts and Accessories Necessary for Safe Operation and 49 CFR 571 Federal Motor Vehicle Safety Standards 

[29 CFR 86 Control of Air Pollution]

Air Ambulance

The USDOT's Federal Aviation Administration (FAA) regulates Air ambulance and helicopter by providing information and guidance applicable to EMS-Air operations. Congress enacted the Airline Deregulation Act [49 USC § 41713] in 1978 that included a preemption clause that has been since broadly interpreted by several courts, which allows states and local officials to regulate medical care by air medical providers.[14]