Promoting Innovation in EMS

Mount Sinai Health System | University of California, San Diego

PROMOTING INNOVATION IN EMERGENCY

MEDICAL SERVICES

PROJECT LEADERSHIP

PROJECT PRINCIPAL INVESTIGATORS

Kevin G. Munjal MD, MPH Assistant Professor of Emergency Medicine, Associate Medical Director of Prehospital Care, Mount Sinai Health System, New York

James Dunford, MD Professor Emeritus (Emergency Medicine), UC San Diego School of Medicine; EMS Medical Director, City of San Diego

PROJECT STAFF

Hugh Chapin, MD, MS, EMT Project Manager

Avis Harper-Brooks Project Coordinator

Taylor Miller, EMT Research Associate

ADVISORS

Lynne Richardson, MD Vice Chair of Research, Department of Emergency Medicine, Mount Sinai Health System

Christopher Kahn, MD, MPH Associate Professor of Clinical Emergency Medicine; Director, Emergency Medical Services and Disaster Medicine Fellowship; Base Hospital Medical Director, UC San Diego Medical Center

MEMBERS OF THE NATIONAL STEERING COMMITTEE

APPOINTED REPRESENTATIVES

Emergency Nurses Association (ENA) Mary Alice Vanhoy, MSN, RN, NREMT-P Nurse Manager at Shore Emergency Center at Queenstown, Maryland International Association of Fire Chiefs (IAFC) John Sinclair Fire Chief, Kittitas Valley Fire Rescue; Emergency Manager, City of Ellensburg, Washington; Board of Directors, Second VP, IAFC International Association of Firefighters (IAFF) Lori Moore, DrPH, MPH, EMT-P Assistant to the General President, IAFF

American Ambulance Association (AAA) Aaron Reinert, NREMT-P Executive Director, Lakes Region EMS, North Branch, Minnesota; Treasurer, AAA American College of Emergency Physicians (ACEP) Jeff Beeson DO, RN, EMT-P Medical Director for Acadian Ambulance of Texas; EMS Committee, ACEP; NAEMSP

Harry J. Monroe, Jr. Director, Chapter & State Relations, ACEP

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National Association of County & City Health Officials (NACCHO) Jeffrey Elder, MD Director/Medical Director, Emergency Medical Services, City of New Orleans National Association of EMS Physicians (NAEMSP) Brent Myers, MD President-Elect, NAEMSP National Association of EMTs (NAEMT) Jason White, MPA EMS Consultant, Mid-America Regional Council National Association of State EMS Officials (NASEMSO) Tom Nehring Division Director at ND Department of Health, Division of EMS and Trauma; Joint Committee on Rural Emergency Care National Volunteer Fire Council (NVFC) Ed Mund Director At-Large, EMS/Rescue Section, NVFC Visiting Nurse Associations of America (VNAA) Tracey Moorhead, MA President and CEO, VNAA Katrina Altenhofen, MPH State Director, Emergency Medical Services for Children (EMSC) Program, Iowa Department of Public Health; National EMS Advisory Council (NEMSAC) David Cone, MD Professor of Emergency Medicine, Yale University; Chief, Section of EMS; Director, EMS Fellowship MEMBERS AT LARGE

Mike Edgeworth, MD Medical Director, Cigna-HealthSpring; Tele- neurologist, HCA

David Emanuel CEO & Co-Founder, Medlert

Lance Gable, JD Associate Dean of Academic Affairs, Wayne State University Law School Jay Goldman, MD Medical Director of EMS and Ambulance, Kaiser Permanente NCAL

Sharon Henry, MBA President, Evolution Health, West Region

Doug Kupas, MD Associate Chief Academic Officer at Geisinger Health System; Council of Medical Directors, NASEMSO; NAEMSP Baxter Larmon, PhD, MICP Adjunct Professor, Emergency Medicine, the David Geffen School of Medicine at University of California at Los Angeles (UCLA); Founding Director, Prehospital Care Research Forum; National Association of EMS Educators (NAEMSE) Chris Montera Assistant CEO/Chief of Clinical Services, Eagle County Paramedic Services Todd Olmstead, PhD Associate Professor of Public Affairs, Lyndon B. Johnson School of Public Affairs, University of Texas, Austin; James M. and Claudia U. Richter Fellow in Global Health Policy Lainie Rutkow, PhD, JD, MPH Associate Professor, Johns Hopkins Bloomberg School of Public Health

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Scott Somers, PhD Former Vice Mayor, Mesa Arizona City Council; Professor of Practice, ASU College of Public Service; Senior Fellow, GW Center for Cyber and Homeland Security Brenda Staffan Project Director, CMMI, Regional EMS Authority (REMSA)

COMMUNITY STAKEHOLDER INTERVIEWEES

• Eric Beck • John Brennan • Lee Burns

• Brendan Carr • Erin Denholm • Michael Greenberger • Tom Judge • Kurt Krumperman • Margherita Labson • Teresa Lee • Elizabeth Madigan • Kevin McGinnis • Nick Nudell • Neal Richmond

Dan Swayze, DrPH, MBA, MEMS Vice President, COO, Center for Emergency Medicine of Western Pennsylvania, Inc.

Jonathan Washko, MBA, NREMT-P Assistant Vice President, Center for EMS, SkyHealth, Northwell Health

• Robert Rosati • Molly Smith • Mitch Snyder • Lynn White • Michael Wilcox

David Williams, PhD Executive Director, Institute for Healtcare Improvement

Gary Wingrove, EMT-P Director of Government Relations & Strategic Affairs, Gold Cross/Mayo Clinic Medical Transport; Founder and President, Paramedic Foundation Matt Zavadsky, EMT-P, MS-HSA Director of Public Affairs, MedStar Mobile Healthcare; Joint National EMS Leadership Forum, NASEMSO; NAEMT

PREFERRED CITATION

Kevin Munjal, Hugh Chapin, Taylor Miller, Christopher Kahn, Lynne Richardson, James Dunford on behalf of the Promoting Innovation in EMS Steering Committee. “Promoting Innovation in Emergency Medical Services.” New York: The Promoting Innovation in EMS Steering Committee; 2018. Available at: www.emsinnovations.org .

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ACKNOWLEDGEMENTS

enthusiasm and expertise hosting the New York Regional PIE Conference in Manhattan.

Federal Partners This document was produced with support from the National Highway Traffic Safety Administration (NHTSA) Office of Emergency Medical Services, U.S. Department of Transportation, through a cooperative agreement, in collaboration with the U.S. Department of Health & Human Services Assistant Secretary for Preparedness & Response (ASPR), and the U.S. Department of Homeland Security (DHS). The opinions, findings and conclusions expressed in this publication are those of the authors and not necessarily those of NHTSA, ASPR or DHS. We thank the NYMIHA for their steadfast support of this project. The dedication of their interns and the focus on improving EMS and healthcare in New York and beyond is greatly appreciated. West Health Institute The West Health Institute (WHI) was instrumental in the success of the project. We are especially grateful to them for hosting the California Regional PIE Conference in San Diego, CA. We also thank WHI for working with us toward a shared vision of improving healthcare for all Americans, especially our elders. The Greater NewYork Hospital Association (GNYHA) For generations, the GNYHA has been a prominent voice for improving healthcare delivery in the greater New York City area. We are thankful for their support in the PIE project, especially their NewYork Mobile Integrated Healthcare Association (NYMIHA)

Henry J. Kaiser Family Foundation The PIE project leadership thanks the Henry J. Kaiser Family Foundation for hosting the PIE Project National Steering Committee meeting in Washington, D.C. This meeting brought together leaders in EMS and innovation from across the country. Participants in the NY and CA regional meetings Thank you to all of you who attended the PIE project regional meetings in New York and California. These meetings were an important part of the process to bring conversations from the local and regional level to the national stage. Participants in the survey and interviews Surveys and interviews were conducted that brought in ideas and perspectives from across the country. We thank all of you who took the time to provide your input for this important project. Participants in the open comment periods From the beginning of the PIE project we felt it was very important to incorporate the experiences and views of EMS stakeholders across the United States. We would very much like to thank all of you that took the time to review the draft documents and contribute your feedback. RedFlash Group The authors appreciate the support of the RedFlash Group in creating the final document.

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EXECUTIVE SUMMARY

The EMS system in the United States provides a critical foundation for our nation’s health care safety net. While there are many examples of how EMS has made impressive progress in the treatment of critically ill patients, our EMS system suffers from fundamental challenges and remains characterized by wide variations in the way care is delivered. There is enormous divergence at the local, regional, and state level in terms of regulations, educational standards, and availability or coordination of resources. Meanwhile, health care is changing dramatically and is increasingly focused on creating value through higher quality, lower cost care, and on promoting integration across the care continuum. While EMS has often been left out of national health policy discussions, now that health care is rapidly moving towards population-based care management, it potentially has much to contribute, especially given that EMS occupies a unique position at the intersection of public health, public safety and healthcare. Yet, this moment of healthcare transformation may not last forever, and the EMS industry should take steps quickly to promote the environment for innovation. Despite their differences, local and regional communities throughout our nation are facing similar regulatory, financial, and other barriers to promoting innovative models of out-of-hospital care that could better meet the unfilled gaps within our healthcare, public health, and public safety systems. The purpose of this document is to identify the most significant barriers that our local agencies face, to champion opportunities and

strategies to unleash innovation, and ultimately create a framework for local and state EMS entities to use to create a more dynamic EMS system that is more adaptive and responsive to society’s needs. While the federal government has an important role to play, this document seeks to describe how local stakeholders can promote innovation independent of federal action. The “Promoting Innovation in EMS” project leadership assembled a steering committee that included a diverse group of stakeholders including representation from state and local government officials, a disparate group of EMS agencies, health systems, payers, other healthcare professions, and experts in community paramedicine, health economics, public health, and political science. An iterative process of gathering data, soliciting input and providing opportunities for feedback was undertaken that included a national survey, two regional conferences, an open national steering committee meeting, posting of multiple drafts and a public open comment period. In the end, seven major themes of challenges to EMS innovation were identified: regulation, finance, education, regional EMS coordination, interdisciplinary collaboration, medical direction, and data and telecommunications. LAW & REGULATION Legal and regulatory barriers include prohibition of non-emergency use of EMS, limitations on scope of practice, overly burdensome processes to approve pilot programs, inadequate liability protections, lack of portability of EMS certifications or licensure, Emergency Medical Treatment and Active Labor Act

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(EMTALA), misapplication of the Health Insurance Portability and Accountability Act (HIPAA), and certificate of need policies. Strategies to create a more favorable regulatory landscape for innovation include the crafting of new legislation that: 1) ensures the provision of EMS as an “essential service” in all communities; 2) maintains flexibility of practice locations or transport destinations available to EMS providers; 3) delegates the process of defining practitioner levels and “scope of practice” to State EMS regulators rather than the legislature; 4) creates a process to enable rapid cycle innovation and conversion of successful pilots into permanent policy; and finally, 5) that provides comprehensive protection for the performance of quality assurance activities including those that cross organizational boundaries (e.g. hospital and EMS agency). Other strategies to promote innovation include using the state regulatory authority over health insurers to require reimbursement for innovative models of EMS care, addressing EMTALA concerns through hospital by-law amendments or regionalized protocols, enabling portability of licensure, and relaxing certificate of need policies. FINANCE Financial barriers include the requirement by most public and private payers of transportation in order for an EMS claim to be reimbursed, difficulty demonstrating value and patient outcomes, lack of business acumen amongst EMS managers and leaders, and the perceived prevalence of fraud and abuse within the medical transportation industry. Strategies to enable innovation include the decoupling of payment from transportation through the pursuit of pay for performance and bundled payment arrangements, engaging community stakeholders for whom EMS can provide value, creating and pursuing State Medicaid initiatives, focusing on reporting and improving

on emerging quality measures, and embracing telemedicine as an avenue to both improve care and obtain better reimbursement. Other strategies include investments in improving the business capabilities of EMS systems and EMS leaders, using grant opportunities to overcome start-up costs, and taking steps to combat fraud and abuse in order to boost the reputation of the industry and profession. EDUCATION Educational barriers to innovation include the relatively low entry requirements or educational requirements of the profession, the variability in quality of education and instructors, the difficulty in defining or measuring competence, and the lack of financial incentive for paramedics to pursue additional education. encouraging or rewarding paramedics who pursue higher education, developing career ladders and specialty practice opportunities, improving the quality of education through greater preparation of instructors and enhancing educational models and techniques, and increasing provider access to clinical feedback and patient outcomes. REGIONAL COORDINATION Barriers to regional coordination include the hyper-fragmentation of EMS systems and agencies, the high degree of variability from one agency or system to another, and the tension between standardization and local autonomy. Strategies for improving regional coordination include measuring and reporting on quality both by agency and across regions, collaborating on initiatives to improve outcomes across a region for acute life-threatening conditions, supporting regional preparedness, public or population health initiatives equally, regardless of agency type, pooling data to improve analytics or research across a region, exchanging data via a health Strategies to overcome these barriers include raising the bar on educational requirements,

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information exchange, and working to foster a culture of safety both within and between agencies working in the same environment. INTERDISCIPLINARY COLLABORATION Challenges to improved collaboration between EMS and other healthcare disciplines include the historical legacy of operating in different siloes, the lack of existing opportunities for communication and operational, oppositional stances between different disciplines around scope of practice. Strategies to improve interdisciplinary collaboration include aggressively seeking opportunities for dialogue and participation, including conversations peripheral to traditional EMS topics, the creation of partnerships with other organizations to provide combined services or at least exchange information, creating multi-agency partnerships to better align geographically with a hospital or health plans coverage area, and working with other community healthcare stakeholders to create a common vision for the full spectrum of community-based care. MEDICAL DIRECTION & OVERSIGHT Challenges to strong medical direction and oversight and leadership include a still dysfunctional job market, the underutilization of EMS physicians in system design and strategic planning, transforming educational needs for EMS physicians from emergency medicine only to new emphasis on population health, inconsistent roles of state EMS medical directors, and tension between greater physician involvement and paramedic professionalism. Strategies to strengthen medical oversight in order to promote innovation include greater support for medical directors in practice, continuously improving medical director education to meet evolving needs, incorporation of medical directors into agency decision making processes, placing

greater emphasis on measuring outcomes and improving quality, and optimizing the role of state medical directors. DATA & TELECOMMUNICATION Challenges to innovation in the area of data and telecommunication include inadequate data collection and data management capabilities, an incident-based record keeping system that is incongruous to other healthcare systems, an inability to exchange information between agencies or with other healthcare partners, inaccurate understandings and application of federal privacy laws, and slow adoption of new telecommunication technologies. Strategies to overcome these barriers include moving toward longitudinal record keeping practices with more standardization of data elements and processes, pursuit of a universal patient identifier that transcends individual record systems, incentivizing the exchange of health information between EMS agencies and with health information exchanges, encouraging the use of EMS data for public health and population health analytics, partnering with new technology developers to make better use of social media and smart phone capabilities, integrating telehealth into EMS care, and preparing for integration with FirstNet, an interoperable public safety-grade broadband network. CONCLUSION Using the specific recommendations made in this document, the EMS industry and profession can create a more favorable environment for innovation through improved regulatory frameworks, better financial alignment, a stronger educational foundation, greater regional coordination and interdisciplinary collaboration, stronger medical oversight, and enhanced data and telecommunication capabilities.

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CHAPTER 1

INTRODUCTION

THE STATE OF EMS If one set out to design a prehospital care system for the United States from the ground up, it might look very different from the EMS system that we have today. While EMS has made impressive progress in many of the technical aspects of treating critical patients, our current EMS system suffers from some fundamental challenges that inhibit innovation in the industry. As the Institute of Medicine (IOM) explained in 2006, “Fragmentation, silos, and entrenched interests prevail.” 1 There are wide variations in regulation, system design and standards of care. There is suboptimal compliance with evidence-based medicine, national guidelines, and educational standards. Certifications vary greatly from state to state, and there is little collaboration between EMS and the academic community. While many EMS patients often suffer from non- emergent conditions, current models of financial reimbursement, medical direction, and EMS educational standards focus almost exclusively on emergency care. Furthermore, there is very little penetration of modern telecommunication technologies and EMS rarely makes effective use of data or shares information with other agencies, community health stakeholders, or patient care teams. As a result, EMS is neither designed to provide many of the services our communities need nor to adapt to new opportunities. While many barriers to innovation are external to EMS, others are the consequence of purely internal challenges. For

example, the culture of many EMS organizations is bound by traditions and often resistant to innovation. Such resistance has contributed to a lack of recognition of EMS and its integration within the larger health care system. Conformance to the status quo has prevented EMS from adapting to new public safety needs and has contributed to our services becoming a neglected area of public safety, public health, and especially health care in America. AN ALTERNATIVE VISION EMS was at one time on track to developing standardized, high quality, coordinated emergency care as the result of initial direct investments and federal leadership stemming from the 1966 National Highway Traffic Safety Act and the 1973 Emergency Medical Services Systems Act. However, EMS splintered when direct support dissipated in the 1980s. The current system haphazardly evolved in an age of fee-for-service medicine and a hospital-based health care system that promoted an uncoordinated, poorly funded, transportation- focused system that falls short of providing the services communities need. The EMS Agenda for the Future (1996) and the IOM Future of Emergency Care (2007) report proposed a very different EMS system- one that is proactive rather than reactive, and one that delivers necessary care rather than traditional care. According to the EMS Agenda for the Future , “In order to optimize the positive influence of EMS on community health we must move to a system of finance that is proactive, accounting for the costs

1 “Emergency Medical Services at the Crossroads.” In Future of Emergency Care Series edited by Gail L. Warden. Washington, D.C.: Institute of Medicine, 2006.

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of emergency safety net preparedness and aligning EMS financial incentives with the remainder of the health care system.” 2 Similarly, the IOM Report also made the case for integration with the rest of the health care system: “To function effectively, the components of the emergency and trauma care system must be highly integrated. Operationally this means that all of the key players in a given region…must work together to make decisions, deploy resources, and monitor and adjust system operations based on performance feedback.” 3 Going further, we envision an EMS system that maximizes value to the community by bringing definitive care into patients’ homes and providing new and innovative services that support the Triple Aims of improving patient experience, improving the health of populations, and reducing the cost of health care. 4 THE TIME TO INNOVATE IS NOW! Health care has changed dramatically in the past few decades. It has started moving away from fee-for-service medicine and toward realigned incentives focused on value and efficiency. These recent trends have been facilitated and accelerated by the passage of the American Recovery and Reinvestment Act (ARRA) of 2009, which incentivized hospitals and physicians to adopt electronic medical records, and the Patient Protection and Affordable Care Act (ACA) of 2010, which authorized numerous demonstration projects within Medicare including the accountable care organization (ACO). The health care industry is now increasingly focused on creating value through higher quality, less expensive care, and on promoting integration of healthcare across the continuum. The Center for Medicare & Medicaid

Services (CMS) recently announced a dramatic acceleration of the transition to quality-linked payments and alternative payment models. Projected future payment models reflect this change, as shown in Figure 1. 5

FIGURE 1

Target percentage of payments in ‘FFS lined to quality’ and ‘alternative payment models’ by 2016 and 2018

2014

2016

2018

2011 0%

20%

30%

50%

68%

>80%

85%

90%

HISTORICAL PERFORMANCE

GOALS

Alternative payment models (Categories 3-4) FFS linked to quality (Categories 2-4) All Medicare FFS (Categories 1-4)

While EMS has often been a neglected area within the national health policy arena, now that health care is rapidly moving towards population-based care management, it potentially has much to contribute. EMS has the advantage of being mobile, and operates 24 hours a day, 7 days a week rather than just during business hours. It is embedded in nearly every community and has extensive experience working with patients in their homes. While the health care system reorients itself toward community-based care and influencing the social determinants of health, in many ways, EMS providers are a step ahead. With a modest amount of additional training, perhaps they could coordinate care, navigate patients, provide education, and ultimately lower cost and improve

2 “EMS Agenda for the Future.” National Highway Traffic Safety Administration. Last modified 1996. https://one.nhtsa.gov/people/injury/ems/agenda/emsman.html 3 “Emergency Medical Services at the Crossroads.” In Future of Emergency Care Series edited by Gail L. Warden. Washington, D.C.: Institute of Medicine, 2006. 4 Berwick, Donald M., Thomas W. Nolan, and John Whittington. “The triple aim: care, health, and cost.” Health affairs 27, no. 3 (2008): 759-769. 5 Tefera, Lemeneh. “Hospital Value-Based Purchasing Program.” (PowerPoint Slides) https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/HVBP/2013-2015-HVBP-Presentation-.pptx.

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the quality of patient care. Indeed, a 2013 white paper drafted by several federal agencies, entitled Innovation Opportunities in Emergency Medical Services, described the potential for significant savings if viable alternatives to transport to the emergency department were created. 6,7 Yet this moment of health care transformation may not last forever. EMS agencies should take advantage of the shifting landscapes in healthcare to think outside the box, test new ideas, and strive to provide the enhanced care that they are uniquely positioned to deliver. Despite the challenges, the environment has never been more amenable toward creating the system that the EMS Agenda for the Future and the IOM report envisioned. 8

but rather to enable both current innovations seeking sustainability as well as clear the path for those future innovations that are as yet unknown. Though the authors of this document understand the important role Congress and federal agencies play in EMS, this document was primarily written to provide a framework that describes how local stakeholders can promote innovation independent of federal action.

Approach to National Framework: Building Blocks

National Framework Document

Iterative Rounds of Internal & External Feedback

National Steering Committee Meeting

Steering Committee Subgroups by Theme

THE PROMOTING INNOVATION IN EMS PROJECT OBJECTIVE

Regional Stakeholder Meetings: NY and CA

Interviews of Steering Committee and Stakeholders

Public Survey / Information Gathering / Identification of Barriers

DEVELOPMENT OF THE FRAMEWORK Partners representing New York and California, from the Icahn School of Medicine at Mount Sinai, the New York Mobile Integrated Health care Association, and the City of San Diego Emergency Medical Services, in partnership with local and regional stakeholders, worked collaboratively to lead this project seeking to overcome local, regional, state, and national barriers to promoting innovative models of EMS. A steering committee was assembled, consisting of local and state government representatives, a disparate group of EMS agencies including volunteer, commercial, hospital, third service, and fire-based services, experts in the fields of community paramedicine

Local and regional communities throughout our nation are attempting to overcome similar regulatory, financial, and other barriers to promoting innovative models of out-of-hospital care which will better meet the unfilled gaps within our healthcare system. The objective of this project was to engage a diverse group of stakeholders in a national dialogue about common challenges toward EMS innovation faced at the local level. This resulting national framework document seeks to serve as a guide for local communities and states to overcome those barriers and enable rapid cycle testing of promising ideas and treatments. The focus is not on any individual innovation,

6 “Innovation Opportunities for Emergency Medical Services.” National Highway Traffic Safety Administration, Office of the Assistant Secretary for Preparedness and Response, Health Resources and Services Administration. Last modified July 15, 2013. http://www.ems.gov/pdf/2013/EMS_Innovation_White_Paper-draft.pdf 7 Alpert, Abby, Kristy G. Morganti, Gregg S. Margolis, Jeffrey Wasserman, and Arthur L. Kellermann. “Giving EMS flexibility in transporting low-acuity patients could generate substantial Medicare savings.” Health Affairs 32, no. 12 (2013): 2142-2148. 8 Munjal, Kevin, and Brendan Carr. “Realigning Reimbursement Policy and Financial Incentives to Support Patient-Centered out-of-Hospital Care.” JAMA 309, no. 7 (2013): 667-8.

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FIGURE 2: SURVEY RESPONDENTS

39% EMS Agency

1% Police Department

19% Health Care Provider

6% Other 5% Business 3% Technology Company 1% Social Work/Community Based Care 1% Insurance Plan (Payer)

14% Fire Department

11% Government

and mobile integrated health care, health economists, and experts in public health and political science. SURVEYS AND INTERVIEWS Together, the steering committee and project leadership facilitated an expansive exploration of experiences and challenges faced by other localities throughout the United States through a structured process including an open survey and exploratory interviews. Overall, project leadership surveyed 189 EMS stakeholders, and used the survey responses to guide in-depth interviews of 48 providers, industry representatives, and experts. Insights gleaned from this exploratory process were fed into the conversation at subsequent stages, including the creation of our initial five “themes” or

categories of challenges: legal, finance, education, workforce and culture, and data.

SURVEY RESULTS: The 189 survey respondents came from 38 states and included 122 EMS providers, 32 physicians, 18 allied health providers, 43 EMS directors, 46 EMS administrators, and experts in business, public health, law, and policy (there was crossover between professions). EMS providers from commercial, volunteer, municipal, hospital- based, government/military, and public utility agencies were all included in the surveys. Of the 73 innovative projects highlighted in the survey, new clinical interventions, alternative destination initiatives, and programs to support high utilizers were the most common.

FIGURE 3: TYPES OF INNOVATIONS

FIGURE 4: BARRIERS ENCOUNTERED

25

25

20

20

15

15

10

10

5

5

0

0

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SELECTED QUOTES FROM SURVEYS AND INTERVIEWS:

On EMS Design “We built this entire system around this 1% of patients, patients with cardiac arrest, patient with life taking trauma…whereas the 99% of the people, which is really what EMS deals with every single day, we designed a system that may be not the best.” “It would be great to have EMS be patient navigators because most of what they’re doing now is navigating in a way that’s not terribly beneficial for patients” “The ability for EMS to enter into the patient’s home and connect directly to providers (e.g. physicians) has limitless opportunities.” “There should be some process that allows the patient, the paramedic, and the physician – the primary care physician for that patient – to have some discussions, some collaboration, some discussion on care continuum so that the right decision is made for that patient.” “The connection to the PCP for 60-70% of our calls has to be considered. The determination of where that patient is going or even a notification that the patient went to the hospital, the connection to that PCP is weak at best and in most cases I would say non-existent.” On Innovation “I think that perception of HIPAA is more of a barrier than HIPAA actually is. I think that HIPAA has become this overwhelming all-inclusive medium to say no to innovation in a lot of areas.” “You meet with whoever may be impacted by the innovation first, in private. The first time that the head of the nursing union for the hospitals should be hearing about the nurse triaging program is not on the front page of your local newspaper”

town, city, county, state or feds. We, as a profession, have done a pretty poor job demonstrating value.”

On Regulation “The current configuration of EMS at least by statute and regulation … doesn’t reflect in any way, shape or form the way we are actually using the service”

“In most states, the EMS provider is [legally] tagged to an ambulance”

On Data “MIH/CP for [my hospital] is a complete non-starter until the EMS providers are fully integrated into our electronic health [record].” On Quality Measurement “I try to get away from documenting how many calls you made and how fast you got there. Everybody can do that.” On Education “It’s time to rethink initial education and integrate more community and population health into the base.” On Becoming a Profession “Becoming more professional, … I mean [EMS] being more like the rest of health care, where nurses have a degree, doctors have degrees.” “If you don’t pay people enough to feel like they are a part of the health care profession and a professional then it is really tough to expect that we will have people in the profession that are looking at it as a lifetime career” “We have for too long cried to be recognized as pro- fessionals, but are not willing to put in the time to be considered a professional.” “100% of our education for EMS professionals is preparing them for 1/5 calls”

“Proving value for your innovation has, by definition, got to be with your local stakeholders. Now, local could be

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CONFERENCES TO DEVELOP THE FRAMEWORK

The project leadership consolidated the lessons from these two regional conferences into conference proceedings documents and continued to analyze the data from the previous stages of information gathering. In consultation with the steering committee, the original five themes were reorganized into the seven themes that ultimately formed the basis of the current chapters within this document. The themes identified were legal, financial, medical direction, interdisciplinary collaboration, regional EMS coordination, education, and data and telecommunications. Despite the segmenting into chapters, it was recognized that there are complex inter-relationships between the issues discussed in various chapters. The project team wrestled with the idea of including a chapter on “quality” for quite some time but ultimately decided that since quality was the goal that required addressing barriers across all areas and not a distinct category of barriers, it would not be organized into a chapter. Instead, the reader will find strategies to improve quality throughout the document. The steering committee organized itself into small workgroups for each of the seven themes and met to discuss both the recommendations offered by the regional conference attendees as well as the qualitative analysis performed of all interview transcriptions and survey submissions. The steering committee itself then went about the task of writing the next iteration of recommendations and began vetting the emerging draft national framework document. At the midpoint of the project, a national steering committee meeting was held in our nation’s capital to allow for discussion and debate of the key issues identified and advanced by the efforts of Mount Sinai and UCSD. At that national meeting, 77 attendees both in person and via web, heard presentations from the project leadership and

Regional meetings were held in New York and California to advance local efforts to promote innovations in EMS by coming up with local solutions to local challenges. Breaking into small workgroups across the original five themes helped subject matter experts with varied experiences come together to address the same problem. The ideas generated, while intentionally focused on the nuances of the local region, were found to be broadly applicable to other jurisdictions and became the earliest iteration of proposed recommendations to be considered by the steering committee. An example of the discussion can be seen in the following results from a survey of conference attendees:

FIGURE 5A AND 5B: RESULTS OF SURVEY OF REGIONAL CONFERENCE ATTENDEES

Choose 3 issues from below that you feel most impede your innovation project or vision?

27% SCOPE OF PRACTICE (SKILLS, INTERVENTIONS) 26% PROTOCOLS (PROCESS REQUIRED TO CHANGE OR APPROVE) 17% LACK OF LIABILITY/QA PROTECTIONS 11% HIPAA 9% CERTIFICATE OF NEED OF PRIMARY SERVICE AREA 6% PORTABILITY OF CERTIFICATION 4% EMTALA

11%

27%

26%

9%

4%

6%

17%

What is most impeding data integration between EMS and hospital? (Multiple Choice)

26% UNWILLINGNESS OF HOSPITAL LEADERSHIP 22% UNCLEAR RETURN ON INVESTMENT 22% TECHNOLOGICAL LIMITATIONS 19% UNWILLINGNESS OF HOSPITAL EMR’S 6% UNWILLINGNESS OF ePCR COMPANIES 5% UNWILLINGNESS OF EMS AGENCIES

22%

22%

5%

6%

26%

19%

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workgroup members, and voted on each and every one of the proposed recommendations. Written and verbal feedback, as well as web-based submissions, were collected. DEVELOPMENT OF THE DOCUMENT Following dissemination of conference proceedings, the steering committee members as well as other invited stakeholders continued to work in subgroups to explore issues and refine the recommendations ultimately included in this document. The draft recommendations were disseminated in January and February of 2016 for an initial public comment period. Over 150 responses were received. Most of the comments were favorable, while others raised new issues or perspectives. All were thoughtful and contributed to the iterative vetting process that has resulted in the recommendations contained in this document. Each comment was reviewed by the project team and steering committee as the group worked toward a near-final draft. Following a final open comment period in August of 2016, this final product was developed that we hope provides meaningful guidance on how to develop an infrastructure for states, communities, and agencies to promote, authorize, fund, regulate and evaluate innovative demonstration projects in emergency medical services. USING THE FRAMEWORK DOCUMENT As previously stated, we hope that the document can guide state and local EMS entities on the steps needed to unleash innovation in their communities. Along the way, we seek to inspire with examples of innovation in progress. There are numerous citations pointing to national reports, consensus guidelines, and even at times scientific results. However, the attempt was not to define the state of the scientific evidence, nor to report on the

results of policy changes already in effect. Rather, this document by its very nature is forward leaning. Its purpose is to promote innovation and therefore it recognizes that there is evidence for some policy recommendations but not for all. The formation of the recommendations in this document were, as described, formed through an iterative process of exploration, development, feedback, and refinement. The recommendations do not necessarily represent the views of any particular organization or government entity, nor do all of the people associated with the project agree with every single recommendation. The readers of this document should consider the many ideas, observations, examples, and recommendations and develop their own action plan as to what steps can be taken to promote innovation in their state or local community. STRUCTURE OF THE RECOMMENDATIONS We organized the recommendations in this document to be applicable at the local, state and national levels. We use this format, rather than naming specific groups of stakeholders, to acknowledge the diverse ways in which EMS systems operate and are regulated at the state and local level in the United States. For example, in one community for a given issue, the relevant state EMS authority might be the State Office of EMS, however in another community, the authority for the specific issues lies with the State Office of Education, the State Medical Board or with the legislature. Because of this, we sometimes use the labels of local agencies / authorities, state authorities / associations, and national associations / organizations to encompass all of the stakeholders that work at the local, state, and national levels, including providers, payers, and government agencies. The exact details and relationships between stakeholders may vary, but we encourage all users of this document to

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be flexible in their interpretations of the relevant actors, and to consider the recommendations addressed to their level of geographic involvement. Local EMS agencies / authorities comprise a large variety of actors including types of EMS agencies, various levels of providers and managers, and local healthcare stakeholders. These include, but are not limited to:

The term national associations could include, but is not limited to, organizations or associations repre- senting the following stakeholders at the national level: • Large EMS agencies or any of their leaders or providers • Credentialing bodies • Advocacy groups • Advisory groups • Non-governmental organizations • Payers • Other national-level associations outside of the EMS industry engaged in: o Health care While we recognize Congress and federal agencies have an important role to play in promoting EMS innovation, this document focuses its recommen- dations on what the above actors can achieve inde- pendent of federal action. We encourage the reader to apply these recommen- dations to the relevant actors in their communi- ties with the ability to achieve the desired results, rather than feel constrained by our word choice of ‘authorities’ or ‘agencies.’ Also, please note that in this document, we define the term ‘regional’ to be a larger area than the local communities (hospital catchment area, neighboring counties, etc.), but smaller than a state. DESIGNING SUSTAINABLE INNOVATION The business community defines innovation as “the process of translating an idea or invention into a good or service that creates value for which customers will pay.” 9 An important takeaway from this is that innovation is not simply having a new idea; the idea is only the beginning. There are plenty of good ideas, but it takes perseverance and o Public health o Public safety

• Commercial EMS agencies • Fire departments • Volunteer EMS • Hospital-based EMS • Individual EMS providers • Labor groups • EMS administrators • Regional EMS committees • Education/training programs o Academic institutions

o Government sponsored training programs o EMS educators

• Physicians & medical directors • Allied health providers • Local hospitals and health systems • Payers (large self-insured employers) • Local public health resources

The term state authorities could include, but is not limited to, the following stakeholders:

• State legislators • Departments of Health • State Offices of EMS • Offices of Education and accreditation bodies • State EMS Directors • State EMS Medical Directors • State EMS Councils • State EMS Associations • Labor groups • Insurance regulators • State Medicaid committees

9 Business Dictionary. Accessed April 13,2015. http://www.businessdictionary.com/definition/innovation.html

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resources to nurture the right idea and allow it to grow into something that brings value to others. The innovator must capture some of that value for it to be sustainable.

capital. By unleashing the creativity and passion of the workforce, it may be possible to generate new ideas, valuable services or develop ways to improve the patient experience. Constantly Engage New Partners EMS is one part of a greater health care and public safety infrastructure. The patient experience is not limited to the time a patient spends in the back of an ambulance, and thus the innovative EMS leader should look beyond the boundaries of the EMS agency to understand the needs of patients and the community, recognize which needs are not being met, and consider possible solutions. The best solution may or may not be one that EMS is best positioned to offer. The best solutions are often those that require interdisciplinary collaborations. Planning for Sustainability A major challenge of innovation in EMS is that it usually produces value that is difficult to capture, especially in a reimbursement environment that only rewards transportation. Often, an innovative EMS agency launches a pilot program to demonstrate proof of concept, either through a grant or through self-funding. Due to lack of planning for sustainability, many of these pilot programs have to be cut when funding runs out, even if they seemed to or were even proven to provide significant value to the community. If an innovation creates value for patients, communities, health plans, or hospitals, the EMS agency must have a plan from the beginning to measure and capture that value, or it risks providing a valuable service only temporarily. Use Data to Demonstrate Value Having data to support the need for a new good or service is often a critical element of convincing others of the potential value that an innovation might generate. It is often necessary prior to

The idea is only the beginning!

Fostering a Culture of Innovation Steve Jobs was generally considered one of the most successful innovators of his lifetime. His success did not come from great technical knowledge, but rather from an unparalleled ability to know what the customer wanted before the customer did. When his technical expertise was questioned, he famously replied, “You’ve got to start with the customer experience and work backward to the technology. You can’t start with the technology and try to figure out where you’re going to try to sell it.” 10 Both medicine and EMS often fall into the trap of trying to build up a patient care model starting with pathophysiology, technology, and therapeutics. EMS leadership and providers should instead start by asking, “What gaps currently exist in the way our patients are served by the EMS system? By the health care system at large?” A system built around the patient experience will often produce results that improve care, lower costs, increase access, and be sustainable.

Empower Your Workforce to be Entrepreneurs Innovation does not always originate from

leadership. It is often those who work with patients every day who are most acutely aware of gaps in patient care and difficulties in providing services. Inspiring leaders are those who seek to promote a culture where all members of the team are welcome or even encouraged to pursue knowledge, gain insight, and question existing structures. The best resource of any organization is its human

10 Carson, Biz. “Steve Jobs’ reaction to this insult shows why he was such a great CEO.” Business Insider. October 22, 2015. Accessed September 21, 2016. http://www.businessinsider.com/steve-jobs-reaction-to-insult-2015-10

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FINANCIAL SUSTAINABILITY: THE CASE OF REMSA

the investment of resources and capital to get a pilot off the ground. To achieve sustainability, an agency must be able use data to measure the effect of the innovation, improve the innovation, and demonstrate value to the community and to stakeholders. Engage Payers Early An effective strategy that can both help with the securing of data and demonstration of outcomes while also laying the groundwork for sustainability, is to invite potential payers to serve on a steering committee or advisory board of a pilot study. These could be traditional payers or healthcare provider group such as a nursing home, hospital, or independent physicians association, that are beginning to take on financial risk for the cost of care of their patients. An EMS agency can benefit from their wisdom and sharing of data while also beginning to secure their long-term buy-in. These partners can help establish benchmarks and milestones early in the process that would define success from their perspective, for which they might one day be willing to pay. INNOVATION IN PROGRESS EMS sits at the intersection of public health, public safety, and healthcare. There is ample opportunity for innovation across all of these fronts. Throughout the document, examples of innovation are included. In this section, we preview some of the innovation in progress and a few that may be just beyond the horizon. However, in no way should the examples described here or elsewhere in the document be considered the only areas worthy of focus. Clinical Acute Care The core of EMS has always been providing high quality emergency care for acute time-sensitive conditions such as cardiac arrest and trauma. More recently, acute myocardial infarction and stroke have become core clinical areas of focus for EMS. In these and other areas, EMS should be pushing the

The Regional Emergency Medical Services Authority (REMSA) was founded in 1986 as a community-based private non-profit EMS service serving Washoe County (Reno) Nevada. REMSA won a Round 1 Health Care Innovation Award (HCIA) (one of six awarded to EMS in the country) in July, 2012 to launch Community Health Programs including a community paramedicine program, a Nurse Health Line, and an alternative transport destination initiative. The HCIA was awarded by the CMS Innovation Center to develop “new models of care and payment that continuously improve health and healthcare for all Americans.”

Analysis & Planning

Build the evidence-base for value-based community health programs Achieve improved stakeholder knowledge of new Community Health Programs

Community Outreach Business Development

Secure contracts with new sources of revenue

Generate support for reform of government payment systems

Public Policy

REMSA planned from the beginning of the grant to build a program that would be sustainable by the time the grant expired. To achieve sustainability, they decided to build a strong evidence base to demonstrate value, then work closely with local stakeholders to form partnerships based on the value they provided. By providing integrated patient-centered, quality care, REMSA saved the health system an estimated $9.6 million over four years and prevented 6,202 ED visits, as of June 2016. Because of its success, REMSA was able to secure contracts with local hospitals and commercial insurers that allowed it to continue to serve the community once the grant expired in July of 2016. On a larger scale, REMSA committed itself to advocating for reforming payment models that reward value, which will create a healthcare environment that makes these programs more sustainable in the future. In August 2016, CMS approved a Nevada Medicaid State Plan Amendment (SPA) that updates coverage and reimbursement to include Community Paramedicine services. In addition, Medicaid and all commercial insurers are reimbursing REMSA for transport to alternative destinations.

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