New law stops potential criminalization of EMS ‘standing orders’ for timely controlled-substance use

A new bipartisan law, the Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, signed by President Trump on November 17, 2017, amends the Controlled Substances Act (CSA) (P.L. 91-513) to clarify that emergency medical services (EMS) professionals (including nurses, paramedics, and emergency medical technicians) are able to continue administering controlled substances (contained in schedules II, II, IV, or V) to critical patients, such as pain narcotics and anti-seizure medications, pursuant to standing (written medical protocol) or verbal (oral directive) orders when authorized by state law (Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, enacted November 17, 2017).

It has been a long-standing practice for medical directors of EMS agencies to write standing orders for the administration of controlled substances by EMS professionals. As reported by Emergency Physicians Monthly, in a January 2015 meeting with the National Association of EMS Physicians (NAEMSP) Executive Committee to discuss possible EMS regulations, the Drug Enforcement Administration (DEA) stated its position that the CSA only allows for patient-specific orders for controlled substances and that it is illegal for EMS agencies to deliver any controlled substances under written medical protocols or standing orders. Therefore, absent this new legislation, it was the position of the DEA that any regulations concerning EMS agencies would be required to prohibit the continued use of standing orders for EMS professionals.

The law also allows EMS agencies the option of having a single DEA registration in each state where the EMS agency administers controlled substances, in lieu of requiring a separate registration for each location of the EMS agency within the state, as long as certain transportation, storage, re-stocking, and recordkeeping rules for controlled substances are followed by the EMS agency. The act further provides that a hospital-based EMS agency may use the DEA registration of the hospital to administer controlled substances without an additional registration of its EMS agency.

The law was introduced as H.R. 304 in the House of Representatives by Reps. Richard Hudson (R-NC) and G.K. Butterfield (D-NC). The Senate version, S. 916, was introduced by Sens. Bill Cassidy (R-La) and Michael Bennet (D-Colo). H.R. 304 initially passed the House by a vote of 404-0 on January 9, 2017. It passed the Senate, as amended, by unanimous consent, on October 24, 2017.

Essential resources for health care providers & attorneys during hurricane season

Hurricane season has arrived and health care providers in affected areas are focusing on providing services to injured individuals and rebuilding damage to facilities, but not necessarily on compliance with Medicare and Medicaid laws and regulations. To assist providers, federal and state agencies are temporarily waiving some regulatory requirements and providing other emergency services. While active hurricane recovery efforts are underway, Health Law Daily will feature links to federal and state resources.

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CMS steps up emergency preparedness under Final rule

CMS is requiring Medicare and Medicaid providers to take additional steps to plan for disasters and emergency situations under a new Final rule. In addition to requiring providers to develop their own plans for emergency scenarios, the Final rule obligates Medicare and Medicaid providers to prepare for emergencies by coordinating with federal, state tribal, regional, and local emergency preparedness systems. The rule also imposes training requirements on providers. The Final rule, issued as an advanced release, is set to be published in the Federal Register on September 16, 2016.

Best practices

Under current rules, providers are required to have some emergency preparedness. For example, hospitals must provide for emergency power and lighting in specified areas and provide facilities for emergency gas and water supply. However, CMS believes the current requirements fall short. The Final rule seeks to improve on the status quo by centering requirements on what CMS calls “common and well-known industry best practice standards” for emergency preparedness, including the development of: (1) risk assessment based emergency plans; (2) policies and procedures based upon the risk assessment; (3) a coordinated communication plan to reach within facilities, across providers, and to State and local public health departments and emergency systems; and (4) and a training and testing program including drills and exercises.

Provider-specific requirements

Although all providers are obligated to comply with the Final rule’s best practices, specific requirements vary for individual provider types. For example, outpatient providers, ambulatory surgical centers, and end-stage renal disease facilities are not obligated to develop policies and procedures for provision of subsistence needs. For other providers, there are additional requirements. For example, under their emergency plans, hospitals, critical access hospitals, and long term care facilities must install emergency and standby power systems. Health care providers and suppliers impacted by the rule have one year from the effective date—60 days after publication—to comply with the new regulations.