and regulatory barriers can prevent or delay the adoption of promising models of care delivery. While innovation can and often does occur despite these limitations, the EMS community should seek to establish a more favorable legal and regulatory environment that enables and encourages both new innovation as well as implementation of new treatments and care models that have been proven elsewhere, all while maintaining the state’s duty to protect the public. Certainly, EMS agencies are encouraged to consider pursuing innovation within the realm of acute care services that are less likely to run afoul of current statute and regulation, and to think creatively about ways to implement new models of care into existing frameworks. For inspiration or scientific evidence, one might look to academic journals, trade magazines, regional and national conferences, etc. For assistance on understanding the limits of what is authorized in his or her state, one might refer to the HHS-ASPR sponsored study entitled “Expanding the Roles of Emergency Medical Services Providers: A Legal Analysis,” 35 or to the state Office of EMS, or seek a determination from the Office of the Attorney General. However, if EMS is to be fully embraced by other health care stakeholders and move forward into a brave new era of innovation and collaboration, the PIE steering committee recommends that states take action to review, modify or update their legislative and regulatory frameworks to be consistent with a set of principles that will enable rather than inhibit innovation. It is the hope of the committee that readers may use these guiding principles and key points to create legislation that both enables early adoption of evidence- based best practices and promotion of innovative practices in EMS that are right for their state. Local
FEDERAL STATUTES WITH FAR-REACHING IMPLICATIONS While primarily an issue related to data sharing and communication, the Health Insurance Portability and Accountability Act (HIPAA) is often misunderstood and used as a reason for hospitals and health information exchanges to be unwilling to exchange data with EMS systems. This occurs despite the existence of a HHS-ASPR-produced clarification document on this issue in 2012. 34 Another federal law, the Emergency Medical Treatment and Active Labor Act (EMTALA), also presents some barriers to EMS innovation. EMS systems that are hospital-operated are required to function within a framework that was not designed for out-of-hospital patient care settings. a certificate of need (or something similar) to provide EMS services, and a number of states and smaller jurisdictions designate a primary service area in which other EMS services may not enter or care for patients. While this can be an important tool for accountability and protection of the public, it can also be a barrier to new entrants into a given market, which thus has a negative impact on innovation. STRATEGIES TO CREATE A MORE FAVORABLE REGULATORY LANDSCAPE PROMOTION OF AN INNOVATION-FRIENDLY LEGAL ENVIRONMENT As the traditional role of EMS providers evolves to meet the needs of local communities and the changes required by health care reform, legislative CERTIFICATE OF NEED POLICIES To our knowledge, approximately 12 states require
34 Nicole Lurie, letter to Dia Gainor, Assistant Secretary for Preparedness & Response, Department of Health & Human Services. Sharing Patient Health Outcome Information between Hospitals and EMS Agencies for Quality Improvement. Washington, D.C. 13 Aug. 2012. MS. 35 Hodge, James G., Jr., Daniel G. Orenstein, and Kim Weidenaar. Expanding the Roles of Emergency Medical Services Providers: A Legal Analysis.Report. Sarah Day O’Connor College of Law, Arizona State University. Arlington, VA: Association of State and Territorial Health Officials, 2014.
MOUNT SINAI HEALTH SYSTEM | UNIVERSITY OF CALIFORNIA, SAN DIEGO
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