The Commonwealth of Massachusetts
Executive Office of Health and Human Services
Department of Public Health
250 Washington Street, Boston, MA 02108-4619
To: Commissioner Monica Bharel, MD and Members of the Public Health Council
From: Lindsey Tucker, Associate Commissioner; Eric Sheehan, Director, Bureau of Health Care Safety and Quality
Date: August 23, 2016
RE: Informational Briefing on Proposed Regulation 105 CMR 173.000 – Mobile Integrated Health Care and Community EMS Programs
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I. Introduction
The purpose of this memorandum is to provide the Public Health Council (PHC) with information about proposed regulation 105 CMR 173.000: Mobile Integrated Health Care and Community EMS Programs.
This regulation, required by Section 138 of Chapter 46 of the Acts of 2015, governs the evaluation and approval of Mobile Integrated Health Care (MIH) and Community EMS Programs in accordance with M.G.L. c. 111O. The proposed regulation ensures a high quality of care, industry standardization, and strong consumer protection. Information on the proposed regulation is included below, including an overview of the law, the Department of Public Health’s (DPH) regulatory development process, goals of the proposed regulation, and a summary of proposed regulatory provisions.
II. Background
The state’s MIH law was passed in 2015, as sections 92, 93, and 138 of the Fiscal Year 2016 General Appropriations Act, and is the first statewide MIH law in the U.S. The law designates DPH as the lead MIH agency and directs DPH to promulgate regulations governing the evaluation and approval of MIH Programs and Community EMS Programs. Currently, there are over 100 MIH programs in 30+ states, including two ongoing pilots within Massachusetts.
The law is designed to establish MIH Programs that will:
· Ensure Emergency Medical Service (EMS) personnel are enabled to practice within full scope of practice, including in non-emergency settings;
· Provide existing providers (e.g., Visiting Nurse Agencies (VNA) and Home Health Agencies (HHA)) with care and transportation/referral alternatives – presently, the only option is calling 911 and emergency transportation to an Emergency Department (ED);
· Incentivize new and innovative models of care delivery through new partnerships between health care organizations;
· Create new tools to lower overall ED utilization rates by allowing transport to alternate destinations when clinically appropriate; and
· Address gaps in service delivery and prevent harmful or wasteful healthcare resource delivery.
The law is designed to establish Community EMS Programs that will expand abilities of local communities to offer public health prevention, health promotion, and health education services to residents. Examples include naloxone distribution and administration education, conducting falls assessments and prevention, blood pressure monitoring, and evidence-based concussion trainings.
III. Regulatory Development
The MIH law also establishes an MIH Advisory Council to assist and support DPH with regulatory development and implementation. The membership of this advisory council is established in statute and includes broad representation from the health care community, including representation from payers and practitioner as well as hospital, EMS, and elders care industry groups. Over five meetings, this Advisory Council discussed how DPH could best implement an MIH Program and Community EMS Program review process that meets the goals above. Major themes from those meetings include:
o The review process should not impose additional regulation on practitioners operating within their scope of practice (e.g., nurses), but should appropriately allow practitioners to provide care in ways and settings not presently covered by DPH regulation (e.g., paramedics).
o The regulation should establish a framework for the application review process, rather than codify specific requirements and metrics in regulation.
IV. Proposed Regulation
The proposed regulation defines and establishes approval requirements for both MIH Programs and Community EMS Programs. Additionally, the proposed regulation authorizes the Department to inspect both program types and establishes grounds to deny, revoke, or refuse renewal of program approval. Specifics for each program type are described below.
MIH Programs
MIH Program is defined as an approved program that uses community paramedic services to deliver healthcare services (such as chronic disease management, behavioral health, preventive care, post-discharge follow up, or transfer or referral to other facilities other than the ED) in an out-of-hospital environment in coordination with other health care facilities or providers (such as primary care, HHAs, VNAs). Any combination of healthcare providers and/or payers is eligible to apply for MIH approval, so long as the program will use community paramedic services.
Programs may also include an “ED Avoidance Component”, which would allow paramedics with advanced training and medical direction to assess and appropriately triage a patient as either an emergency patient (i.e., 911 patient going to the ED) or as an MIH patient (i.e., eligible for in-home treatment and/or transfer to a healthcare facility other than the ED). For approval to operate an MIH Program with an ED Avoidance Component, the proposed program must meet all MIH Program minimum requirements, as well as heightened requirements regarding appropriate triage protocols, including medical direction, advanced training for paramedics, and procedures to coordinate and manage care of any 911 EMS patient deemed appropriate for MIH Program care. In addition, in order to be eligible for approval to operate an MIH Program with an ED Avoidance Component, the MIH Program must include the local primary ambulance service (i.e., the service responding to 911 calls).
When applying, applicants must
1) identify gaps in service delivery within their defined patient population or region, and
2) show how the program would address those gaps through one or more of the following:
o Decrease in avoidable ED visits or hospital readmissions;
o Decrease in total medical expenditures;
o Decrease in costs to the patient;
o Decrease in time to patient care in appropriate patient setting;
o Increase in access to care under direction of patient’s PCP;
o Improvement in care coordination;
o Increase in patient satisfaction;
o Improvement in patient’s quality of life; or
o Increase in cultural and linguistic competencies.
Applicants must show how all providers/groups involved will coordinate care for their defined patient population or region. This plan can target one care area, such as chronic disease management or behavioral health, or target multiple care areas.
The regulation requires approved programs to meet minimum operating standards, including:
o Filing serious incident reports with DPH, consistent with other DPH licensure regulations;
o Establishing policies and procedures addressing a wide range of topics, such as development and review of clinical protocols, management of both 911 patients and MIH patients, infection control, and continuous quality improvement; and
o Designating a medical director responsible for clinical protocols and ensuring personnel are properly trained and provide care within their scope of practice.
Community EMS Programs
Community EMS Program is defined as a program operated by the local public health authority (e.g., Local Board of Health) and utilizing the primary ambulance service’s EMS personnel to provide community outreach and assistance to advance illness or injury prevention. Only the local public health authority may apply. These programs can only engage in low-risk evidence-based services specified in DPH guidance, such as naloxone distribution and administration education, falls prevention and assessments, blood glucose monitoring, low-risk vaccinations, and concussion training. Applicants would be required to notify DPH which subregulatory services the program would engage in, and unless otherwise communicated by DPH to the applicant, approval is presumed after the notification is received.
V. Summary
Staff intends to conduct the public comment hearing and return to the PHC to report on testimony and any recommended changes to the proposed regulation. Following final action by the PHC, the Department will be able to file the final amendment with the Secretary of the Commonwealth.
The proposed regulation is attached to this memorandum.
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