105 CMR 173.00 — Mobile integrated health care and community EMS programs

105 CMR: DEPARTMENT OF PUBLIC HEALTH 105 CMR 173.000: MOBILE INTEGRATED HEALTH CARE AND COMMUNITY EMS PROGRAMS Section

105 CMR 173.00 Mobile integrated health care and community EMS programs

173.010 Scope and Applicability

173.010: Scope and Applicability

173.020 Definitions

173.020: Definitions

173.030 Application Process

173.030: Application Process

173.040 Minimum Requirements for MIH Program Approval

173.040: Minimum Requirements for MIH Program Approval

173.050 Additional Eligibility and Minimum Requirements for MIH Applicant with ED Avoidance

173.050: Additional Eligibility and Minimum Requirements for MIH Applicant with ED Avoidance Component

173.060 Community EMS Program Approval

173.060: Community EMS Program Approval

173.070 Certificate of Approval

173.070: Certificate of Approval

173.080 Grounds for Denial, Revocation, or Non-renewal of Approval

173.080: Grounds for Denial, Revocation, or Non-renewal of Approval

173.090 Process for Denial, Revocation or Refusal of a Certificate of Approval for an MIH or

173.090: Process for Denial, Revocation or Refusal of a Certificate of Approval for an MIH or Community EMS Program

173.100 Minimum Standards of Operation

173.100: Minimum Standards of Operation

173.110 Complaints

173.110: Complaints

173.120 Inspections, Statement of Deficiency, Order to Correct

173.120: Inspections, Statement of Deficiency, Order to Correct

173.130 Summary Suspension of Certificate of Approval

173.130: Summary Suspension of Certificate of Approval

173.140 Waiver of Requirements

173.140: Waiver of Requirements

173.150 Severability

173.150: Severability

173.010 Scope and Applicability

173.010: Scope and Applicability (A) Unless otherwise expressly permitted by the Department, no person or entity shall establish, maintain, or hold itself out as an MIH or Community EMS Program as defined in 105 CMR 173.020 without a valid Certificate of Approval issued by the Department in accordance with 105 CMR 173.000. (B) 105 CMR 173.000 applies to: (1) Every person who seeks a valid Certificate of Approval from the Department to establish an MIH or Community EMS Program; and (2) Every person who operates an MIH or Community EMS Program.

173.020 Definitions

173.020: Definitions As used in 105 CMR 173.000, the following definitions shall apply unless the context requires otherwise: 911 EMS Patient. An individual who has activated a Primary Ambulance Response by dialing the emergency telephone access number 911, or its local equivalent. Ambulance Service. An entity licensed by the Department pursuant to 105 CMR 170.000: Emergency Medical Services System to provide emergency medical services. Applicant. A Community EMS Applicant or an MIH Applicant as further defined. Authorization to Practice. The approval granted to EMS Personnel by the medical director of the MIH or Community EMS Program approved by the Department pursuant to 105 CMR 173.000. Certificate of Approval. Written approval to operate an MIH or Community EMS Program pursuant to 105 CMR 173.000, subject to all terms and conditions contained in the Certificate of Approval. Commissioner. The Commissioner of Public Health or his or her designee. Community EMS Applicant. A local public health authority seeking an initial Certificate of Approval or renewal thereof to operate a Community EMS Program in partnership with the local jurisdiction's designated primary ambulance service. 9/7/18 - (corrected in Mass. Register 1375 10/5/18) 105 CMR - 1043

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.020 continued

173.020: continued Community EMS Program. A program operated by the local public health authority and developed in coordination with the local jurisdiction's designated primary ambulance service(s) and which utilizes the primary ambulance service's EMS Personnel to provide community outreach and assistance in order to advance illness or injury prevention within the local jurisdiction(s) in accordance with 105 CMR 173.060. The Community EMS Program shall be approved by the local jurisdiction, in the manner required by such jurisdiction, and the ambulance service's affiliate hospital medical director. Community Paramedic. A person who: (1) is certified as a paramedic pursuant to M.G.L. c 111C and 105 CMR 170.000: Emergency Medical Services System; (2) has successfully completed an education program developed or selected by the medical director of the MIH Program for which the community paramedic is employed, as well as any additional training required by Department guidelines; and (3) is dispatched by an MIH Program to provide services or treatment to a patient within his or her scope of practice in accordance with Department-issued Statewide Treatment Protocols and clinical protocols of the program. Department. The Department of Public Health, pursuant to M.G.L. c. 17, § 1. Duplication of Services. A proposed service which does not address a gap in service delivery, pursuant to 105 CMR 173.040(A). ED Avoidance. A component of an MIH Program pursuant to 173.050 that includes the applicable local jurisdiction(s)'s designated primary ambulance service(s) and, following primary ambulance response, assessment and consultation with on-line medical direction, utilizes paramedics with advanced training to manage the patient as an MIH patient in accordance with the provisions of 105 CMR 173.100(A) and Department guidelines. Emergency Medical Technician (EMT). An EMT-Basic, Advanced EMT or Paramedic certified by the Department pursuant to 105 CMR 170.000: Emergency Medical Services System. Emergency Service Program (ESP). A designated program under the direction of the Department of Mental Health and MassHealth Office of Behavioral Health that provides behavioral health crisis assessment, intervention and stabilization services through four service components: (1) Mobile Crisis Intervention (MCI) services for youth; (2) adult mobile services; (3) ESP community based locations; (4) and community crisis stabilization (CCS) services for 18 years of age and older. EMS. Emergency medical services, as defined in 105 CMR 170.000: Emergency Medical Services System. EMS First Responder (EFR). A person certified pursuant to 105 CMR 170.000: Emergency Medical Services System who has, at a minimum, successfully completed a course in emergency medical care approved by the Department pursuant to M.G.L. c. 111, § 201 and 105 CMR 171.000: Massachusetts First Responder Training and who provides emergency medical care through employment by, or in association with, a licensed EFR service at the first responder level. EMS First Response Service (EFR Service). An entity licensed by the Department pursuant to 105 CMR 170.000: Emergency Medical Services System to provide rapid response and EMS. EMS Personnel. EFRs and EMTs. Entity or Person. An individual or his or her estate upon his or her death, or a corporation, a government agency, a partnership, a trust, an association, or an organized group of persons, whether incorporated or not, or any receiver, trustee, or other liquidating agent of any of the foregoing while acting in such capacity. 9/7/18 105 CMR - 1044

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173.020 continued

173.020: continued Health Care Entity. A health care facility, health care provider, local public health authority, provider organization, carrier, or any combination thereof, including, but not limited to, an ambulance service licensed under M.G.L. c. 111C, a visiting nurse association, an accountable care organization, or a home health agency. Health Care Facility. A licensed institution providing health care services or a health care setting, including, but not limited to, hospitals and other licensed inpatient centers, ambulatory, surgical or treatment centers, skilled nursing centers, residential treatment centers, diagnostic, laboratory and imaging centers, and rehabilitation and other therapeutic health settings. Health Care Personnel or Personnel. An individual or individuals employed by or affiliated with a health care provider, who provide direct patient care. Health Care Personnel may include, but not be limited to, Community Paramedics, EMS Personnel, EMS First Responders, nurses, Nurse Practitioners, Physician Assistants, or social workers. Health Care Provider. A provider of medical, behavioral or health services or any other person or organization that furnishes bills or is paid for health care services delivery in the normal course of business. Injury. Harm that results in exacerbation, complication or other deterioration of a patient's condition. Local Jurisdiction. A city or town or multiple cities or towns. Local Public Health Authority. The appropriate and legally designated health authority of the city, town, or other legally constituted governmental unit within the Commonwealth having the usual powers and duties of the board of health or health department of a city or town. Medical Control. The clinical oversight provided by a physician or existing primary care provider to all components of the MIH Program, including, but not limited to, medical direction, training, scope of practice and authorization to practice of EMS Personnel, which may include community paramedics, continuous quality assurance and improvement and clinical protocols. Medical Direction. The authorization for treatment provided by a physician or existing primary care provider in accordance with clinical protocols, whether on-line through direct communication or telecommunication, or off-line through standing orders. Medical Director. The physician or physicians appropriately trained to meet the unique social/cultural, linguistic, medical and population health needs of an MIH Program's patient population and designated by the MIH Program to carry out any supervisory medical control responsibilities for the MIH Program. MIH Applicant. A health care entity or entities seeking an initial Certificate of Approval or renewal thereof to operate an MIH Program. MIH Patient. An individual identified by a health care entity as warranting MIH Program services. Mobile Integrated Health Care Program (MIH Program). A Department-approved program, including MIH Programs with an ED Avoidance Component, that utilizes EMS Personnel, which may include community paramedics to deliver healthcare services to patients in an out-of- hospital environment in coordination with health care facilities or other health care providers, which may include, but not be limited to, primary care providers, home care agencies, visiting nurse associations, or other in-home services; provided, that the medical care and services may include, but not be limited to, chronic disease management, behavioral health, preventative care, post-discharge follow-up visits, or transport or referral to facilities other than hospital emergency departments. 9/7/18 105 CMR - 1045

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173.020 continued

173.020: continued Nurse Practitioner. A licensed registered nurse authorized by the Massachusetts Board of Registration in Nursing to practice in the Commonwealth of Massachusetts as an Advanced Practice Registered Nurse pursuant to 244 CMR 4.00: Advanced Practice Registered Nursing and whose scope of practice includes the provision of primary care services. Physician. A physician duly licensed to practice medicine in the Commonwealth of Massachusetts by the Massachusetts Board of Registration in Medicine, pursuant to M.G.L. c. 112, § 2 and 243 CMR: Board of Registration in Medicine. Physician Assistant. A person who is registered pursuant to 263 CMR: Board of Registration of Physician Assistants and who may provide medical services appropriate to his or her training, experience and skills under the supervision of a registered physician. Primary Ambulance Response. First-line ambulance response, pre-hospital treatment and, if applicable, transportation by an ambulance service designated as a service zone provider or recognized in a service zone plan to provide first-line ambulance response, pre-hospital treatment and transportation pursuant to a provider contract. Primary Ambulance Service. The business or regular activity, whether for profit or not, by an ambulance service licensed pursuant to 105 CMR 170.000: Emergency Medical Services System, designated under a service zone plan for the purpose of providing rapid response and pre-hospital EMS, including, without limitation, patient assessment, patient treatment, patient preparation for transport and patient transport to appropriate health care facilities, in conformance with the service zone plan. Primary Care Provider. A physician, physician assistant or nurse practitioner qualified to provide general medical care who: (1) supervises, coordinates, prescribes, or otherwise provides or proposes health care services; (2) initiates referrals for specialist care; and (3) maintains continuity of care within the scope of practice. Provider Organization. Any corporation, partnership, business trust, association or organized group of persons, which is in the business of health care delivery or management, whether incorporated or not, that represents one or more health care providers in contracting with carriers or third-party administrators for the payment of health care services; provided that the definition shall include, but not be limited to, physician organizations, physician-hospital organizations, independent practice associations, provider networks, accountable care organizations, and any other organization that contracts with carriers or third-party administrators for payment for health care services. Scope of Practice. The clinical skills or functions that: (1) are defined by applicable state laws and regulations governing certification, licensure or registration of each individual providing services or treatment in the MIH or Community EMS Program approved by the Department pursuant to 105 CMR 173.000; and (2) the clinical protocols developed by such programs. Serious Incident. An incident that results in injury to a patient not ordinarily expected as a result of the patient's condition.

173.030 Application Process

173.030: Application Process (A) An applicant shall submit all required documents and non-refundable fees to the Department in a manner and form as determined by the Department. The Department may expedite review of applications with a focus on underserved populations. The Department may request additional documentation and materials as deemed appropriate. (B) An applicant seeking renewal of a Certificate of Approval shall submit all required documentation and non-refundable fees at least 120 calendar days prior to the expiration of the program's current Certificate of Approval. 9/7/18 105 CMR - 1046

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.030 continued

173.030: continued (1) If all required documentation and fees are submitted to the Department in a complete and timely fashion, as determined by the Department, the Certificate of Approval shall not expire until the Department has made a determination on the application for renewal. (2) If the required documentation and fees are not submitted to the Department in a timely fashion, as determined by the Department, the Certificate of Approval shall expire at the direction of the Department, and the MIH or Community EMS Program may not continue to operate without the express written permission of the Department.

173.040 Minimum Requirements for MIH Program Approval

173.040: Minimum Requirements for MIH Program Approval (A) A complete application for MIH Program Approval shall, at a minimum: (1) Identify and validate one or more gaps in service delivery using data and a corresponding community health needs assessment; (2) Describe how the proposed MIH Program would address identified gaps in service delivery and provide improvements in quality, access, and cost effectiveness, an increase in patient satisfaction, improvement in patients' quality of life, and an increase in interventions that promote health equity, including cultural and linguistic competencies, through one or more of the following: (a) A decrease in avoidable emergency department visits or hospital readmissions; (b) A decrease in total medical expenditures; (c) A decrease in cost to patient; (d) A decrease in time to appropriate patient care in an appropriate health care setting; (e) An increase in access to medical or follow-up care under the direction of the patient's Primary Care Provider; or (f) Improvement in clinical care coordination, including, but not limited to the patient's adherence to medication and other therapies previously prescribed by the patient's Primary Care Provider. (3) Pursuant to M.G.L. c. 111O, § 2(b)(iii), describe any proposed partnerships with existing health care entities; identify all partnerships, contracts, agreements, and affiliation agreements between the applicant and other health care entities; and propose a plan for coordination and use of existing personnel and resources without duplication of services; (4) For proposed programs with a primary focus on MassHealth beneficiaries with behavioral health needs, identify partnership or coordination with an ESP; (5) Demonstrate, through such information as financial and legal viability, sustainability and compliance history, sufficient capacity to develop and operate the proposed MIH Program in accordance with 105 CMR 173.000; (6) Designate a medical director who shall be responsible for meeting the requirements of all clinical aspects of the proposed MIH Program, including, but not limited to, 105 CMR 173.100(A)(9); (7) Provide a complete description of the proposed operational plan for medical control and medical direction including, but not limited to, lines of authority and responsibility, development and review of clinical protocols, training and assessment of skills, communication systems, and continuous quality assurance and improvement; and (8) Provide a complete description of the proposed coordination and interaction with applicable 911 EMS systems in accordance with the provisions of 105 CMR 173.100. (B) Upon receipt of a complete initial or renewal application for a Certificate of Approval to operate an MIH Program, the Department shall evaluate the application, and any other information requested by the Department, and determine approval based on the applicant's satisfaction of the minimum requirements set forth at 105 CMR 173.040(A).

173.050 Additional Eligibility and Minimum Requirements for MIH Applicant with ED Avoidance

173.050: Additional Eligibility and Minimum Requirements for MIH Applicant with ED Avoidance Component (A) An MIH Applicant must include each designated primary ambulance service(s) in the applicable local jurisdiction(s) in order to be eligible to apply for a Certificate of Approval to operate an MIH Program that includes an ED Avoidance component. (B) A complete application for MIH Program with ED Avoidance Component shall, at a minimum: 9/7/18 105 CMR - 1047

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.050 continued

173.050: continued (1) Meet the minimum requirements set forth at 105 CMR 173.040(A); (2) Include appropriate clinical and triage protocols and advanced training for paramedics who will operate under the proposed ED Avoidance programming in accordance with 105 CMR 173.050 and protocols established by the Department pursuant to M.G.L. c. 111O; and (3) Describe the coordination and management of any 911 EMS patient who the responding paramedic finds, after assessment and consultation with online medical direction, may be more appropriately managed as an MIH patient, in accordance with the provisions of 105 CMR 173.100(B) and Department guidelines. (C) Upon receipt of a complete initial or renewal application for a Certificate of Approval to operate an MIH Program with ED Avoidance Component, the Department shall evaluate the application, and any other information requested by the Department, and determine approval based on the applicant's satisfaction of the minimum requirements set forth in 105 CMR 173.050(A).

173.060 Community EMS Program Approval

173.060: Community EMS Program Approval (A) Any Community EMS Applicant seeking a valid Certificate of Approval for public health service(s) as defined in Department guidelines issued pursuant to 105 CMR 173.060(B) shall be required to provide notification, in the form and manner as determined by the Department, at least 30 calendar days prior to anticipated commencement of Community EMS Program operations. (B) The Department shall not issue a Certificate of Approval to authorize a Community EMS Program to provide any services other than those evidence-based illness and injury prevention services, such as falls prevention, concussion training, certain vaccinations under local public health authority direction, blood pressure screenings and health promotion screening programs, pursuant to 105 CMR 180.000: The Operation, Approval and Licensing of Clinical Laboratories, that are deemed high-value public health services with low-risk potential to patients as defined by the Department in guidelines and are consistent with identified community health needs. Persons may submit to the Commissioner for consideration by the Department a written request with appropriate supplemental evidence supporting the future inclusion in, or exclusion from, said guidelines of certain evidence-based illness and injury prevention service(s). (C) All EMS Personnel training and activities related to the Community EMS Program must be approved by the local public health agency and the primary ambulance service's affiliate hospital medical director. (D) The designated primary ambulance service's affiliate hospital medical director shall: (1) Ensure all EMS Personnel providing services in a Community EMS Program successfully complete additional training tailored to meet the specific needs of the particular Community EMS Program; (2) Review the quality of the EMS Personnel's delivery of services; and (3) Ensure EMS Personnel provide services only within their scope of practice.

173.070 Certificate of Approval

173.070: Certificate of Approval (A) Following Department determination that the proposed MIH or Community EMS Program has met the minimum requirements of 105 CMR 173.000, the Department shall issue a Certificate of Approval to the applicant, subject to any terms and conditions specified by the Department. (B) Unless otherwise expressly denied by the Department in writing, notification, as set forth in 105 CMR 173.060(A), shall constitute a valid Certificate of Approval for the purposes of a Community EMS Program pursuant to 105 CMR 173.060 and 173.070. (C) A Certificate of Approval shall be valid for two years from the date of issue unless otherwise specified in the Certificate of Approval. 9/7/18 105 CMR - 1048

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.070 continued

173.070: continued (D) The Department may deny an application for a Certificate of Approval for any of the reasons set forth in 105 CMR 173.080. (E) A Certificate of Approval may not be transferred or assigned to another service, program, agency, entity, or location. (F) After receipt of a Certificate of Approval, an MIH or Community EMS Program may seek approval of modifications in accordance with processes and criteria established in Department guidance.

173.080 Grounds for Denial, Revocation, or Non-renewal of Approval

173.080: Grounds for Denial, Revocation, or Non-renewal of Approval Each of the following, in and of itself, shall constitute full and adequate ground on which the Department may deny an application for a Certificate of Approval, provide the applicant with the option to resubmit, revoke or refuse to renew a Certificate of Approval to operate an MIH or Community EMS Program: (A) Failure to meet applicable requirements for approval as specified in 105 CMR 173.000; (B) Failure to meet the requirements of applicable federal or state law or regulations; (C) Failure to provide information as required within 105 CMR 173.000; (D) Any action or condition that endangers public health and safety, as determined by the Department; (E) Obtaining or attempting to obtain a Certificate of Approval or renewal thereof by fraud, misrepresentation, or knowing omission(s) of material information, or by submission of incorrect, false or misleading information; (F) Fraud, deceit or knowing omission(s) of material information or providing false or misleading statements, orally or in writing, to the Department; (G) Conviction of an applicant, approved entity or person with significant financial or management interest in the MIH or Community EMS Program, whether proposed or in operation, of Medicare or Medicaid fraud, or other criminal offense related to the operation of the program or indicating that operation of the program may endanger public health or safety; (H) Reasonable basis for the Department to conclude that a discrepancy exists between the representations by the applicant as to the MIH or Community EMS Program services to be afforded patients and the services actually rendered or to be rendered; (I) Failure to meet the duties and responsibilities for MIH or Community EMS Programs as required by 105 CMR 173.000; (J) Failure to comply with any term or condition prescribed by the Department within a Certificate of Approval; (K) Failure to submit an acceptable plan of correction as required under 105 CMR 173.120; (L) Failure to comply with a Department-approved plan of correction or correction order in accordance with 105 CMR 173.120; (M) Denial of entry to Department agents to conduct site visits or inspections, or an attempt to impede the work of Department agents; or (N) Any other violation of M.G.L. c. 111O, 105 CMR 173.000, or related Department guidelines. Nothing in 105 CMR 173.080 shall limit the Department from adopting additional grounds through adjudication. 9/7/18 105 CMR - 1049

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.090 Process for Denial, Revocation or Refusal of a Certificate of Approval for an MIH or Community

173.090: Process for Denial, Revocation or Refusal of a Certificate of Approval for an MIH or Community EMS Program (A) If the Department initiates an action to deny, revoke, or refuse to renew a Certificate of Approval, the Department shall provide the MIH or Community EMS Program with written notice of the reasons and grounds for the Department's action, the provisions of law relied upon, and an opportunity to resubmit the application within 30 calendar days of receipt of the notice of agency action. If the Department denies the resubmitted application, the MIH or Community EMS Program may request an adjudicatory hearing within 14 calendar days of receipt of the notice of agency action. (B) Upon receipt of a request for hearing within the time period prescribed by 105 CMR 173.090(A), the Department shall afford the aggrieved party an opportunity for an adjudicatory hearing to be conducted by a designated hearing officer. (C) If a hearing is not requested within the time period prescribed by 105 CMR 173.090(A), the right to a hearing shall be waived and a final agency decision shall be issued. (D) All adjudicatory proceedings shall be conducted in accordance with M.G.L. c. 30A and 801 CMR 1.01: Formal Rules.

173.100 Minimum Standards of Operation

173.100: Minimum Standards of Operation (A) MIH Programs. An MIH Program shall meet the following minimum standards of operation: (1) If an MIH Program's on-scene personnel, after assessment and in accordance with medical direction, determines that the patient is experiencing a medical emergency, the MIH Program's on-scene personnel shall activate the 911 EMS system and continue to assess and treat the patient in accordance with clinical protocols until transfer of care to the responding ambulance service in accordance with 105 CMR 170.355(B)(2) and (4) and the applicable service zone plan. (2) When a primary ambulance service of a municipality, which is also part of a Department-approved MIH Program with ED Avoidance component, receives a 911 call to respond to a patient within its MIH program, the service shall respond in accordance 105 CMR 170.000: Emergency Medical Services System. If after assessment and consultation with on-line medical direction, the responding paramedic finds the patient may be more appropriately managed as an MIH patient or transported to a destination other than an emergency department, the EMS Personnel may initiate transfer of patient care to the MIH Program with the ED avoidance component in accordance with Department-established protocols and follow the process for timely coordination with the patient's primary care provider, or associated health care entity to establish a primary care relationship, pursuant to 105 CMR 173.100(A)(8)(h). (3) If an MIH Program deploys or intends to deploy a vehicle when responding to an MIH call or for a scheduled home visit, such vehicle must be appropriate for the clinical encounter as approved by the Department. (4) Each MIH Program shall file a written report with the Department within five calendar days of any serious incident involving its program, personnel or property. Such reportable serious incidents shall include, but are not limited to, any of the following covered by its Certificate of Approval: (a) Death that is unanticipated, not related to the natural course of the patient's illness or underlying condition, or that is the result of an error or other incident, as specified in guidelines of the Department; (b) Full or partial evacuation of the facility or residence to which the MIH program responds for any reason; (c) Fire; (d) Apparent suicide; (e) Serious criminal acts; (f) Pending or actual strike action by its employees, and contingency plans for operation of the MIH Program; (g) Any anesthesia-related complications that result in serious morbidity or death of a patient; 9/7/18 105 CMR - 1050

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.100 continued

173.100: continued (h) A motor vehicle crash involving an MIH vehicle reportable under M.G.L. c. 90, § 26; (i) Medication errors resulting in injury; (j) Failure to provide treatment in accordance with clinical protocols resulting in injury; (k) Major medical or communication device failure or other equipment failure or user error resulting in serious injury; or (l) Death, injury, or illness occurring within 24 hours of an MIH with ED Avoidance encounter. (5) Each MIH Program shall immediately report to the Department and appropriate authorities, for any patient treated by the MIH Program, any suspected instance(s) of abuse, neglect, mistreatment of that patient or misappropriation of that patient's property at or by a nursing home, rest home, home health, home maker, hospice, family member and/or others. (6) Each MIH Program shall report to the Department any other serious incident or accident occurring on premises covered by the MIH Program's Certificate of Approval that seriously affects the health and safety of a patient or that causes serious physical injury to a patient within seven calendar days of the date of occurrence of the event. (7) Each MIH Program shall comply with all guidelines established by the Department for submission of data required by 105 CMR 173.100(A)(8)(v). (8) Each MIH Program shall have written policies and procedures consistent with the requirements established in 105 CMR 173.100, Department guidelines, accepted standards of care for the delivery of health care services and treatment, and applicable laws. All policies and procedures required under 105 CMR 173.100(A) shall be provided to personnel providing services or treatment on behalf of an MIH Program. In addition, such policies and procedures shall be made available to the Department upon request. At a minimum, the policies and procedures shall address: (a) Documentation of organizational structure including medical control, affiliation agreements, lines of authority, responsibility, communication, personnel practices, and staff assignment; (b) Statement of goals, objectives and types of services offered by the program; (c) Capability of personnel providing services or treatment in the MIH Program, including confirmation that such personnel are currently certified, licensed or registered in accordance with applicable laws and regulations; (d) Medical control and medical direction, including authorization to practice of EMS personnel; (e) Process for development and periodic review of clinical protocols; (f) Process for obtaining a patient's informed consent at each clinical encounter; (g) Documentation of training and assessment standards for all personnel providing treatment and services; (h) Process for coordinating care with a patient's primary care provider, or associated health care entity to establish a primary care relationship; (i) Process for obtaining medications from a pharmacy in accordance with 105 CMR 700.000: Implementation of M.G.L. c. 94C; (j) Compliance with applicable federal and state laws and regulations, including, but not limited to such laws and regulations governing possession and administration of controlled substances; (k) Process for ensuring that each health care provider providing services and treatment in the MIH Program maintains an appropriate and current registration to possess controlled substances and instruments for administration of controlled substances in accordance with 105 CMR 700.000: Implementation of M.G.L. c. 94C; (l) Compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and regulatory requirements in 42 CFR Part 493; (m) Process for ensuring that each health care provider providing services or treatment in the MIH Program obtains CLIA certificates appropriate for the type of testing to be performed; (n) Maintenance of equipment and medical devices in accordance with manufacturers' recommendations; (o) Compliance with federal and state confidentiality laws and regulations; (p) Security of and access to patient medical records and information; 10/5/18 (Effective 9/7/18) - corrected 105 CMR - 1050.1

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.100 continued

173.100: continued (q) Management of patients who experience a medical emergency and require activation of the 911 EMS system in accordance with the provision of 105 CMR 173.100(A); (r) Management of 911 EMS Patients by a designated primary ambulance service that is part of an approved MIH Program with an ED avoidance component pursuant to 105 CMR 173.050 when the primary ambulance service's responding paramedic appropriately determines whether a patient may be more appropriately managed as an MIH patient or transported to a destination other than an emergency department in accordance with the provision of 105 CMR 173.100(B) and Department guidelines; (s) Dispatch and communications; (t) Infection control procedures; (u) Continuous quality assurance and improvement program; (v) Collection and maintenance of data relative to access, availability, quality, and cost associated with delivery of program services, to be submitted on a quarterly basis in accordance with Department guidelines; (w) Non-discrimination; and (x) Serious incident response and reports in accordance with 105 CMR 173.100(A)(4). (9) An MIH Program's medical director's responsibilities shall include but not be limited to the following: (a) Develop and update clinical protocols appropriate to:

1. the unique medical needs of the MIH Program's patient population; and
2. the particular personnel providing MIH services including, but not limited to, Community Paramedics, EMS Personnel, nurses, Nurse Practitioners, Physician Assistants and others; (b) Grant authorization to practice to Community Paramedics and other EMS Personnel providing health care services on behalf of MIH Programs; (c) Ensure that all MIH Program personnel are properly trained and provide health care services or treatment:
3. within the scope of their practice;
4. in accordance with the clinical protocols developed for the MIH Program; and,
5. in accordance with any additional training required by Department guidelines; (d) Ensure that the MIH Program maintains a secure and effective telecommunication system and that all on-line medical direction is recorded; (e) Make on-line medical direction available to MIH Program personnel during all hours of operation; (f) Ensure that all physicians and other primary care providers who provide on-line medical direction to MIH Program personnel receive appropriate training in:
6. the scope of practice of each type of MIH Program personnel;
7. the specific clinical protocols developed for the MIH Program; and
8. any additional training required by Department guidelines. (g) Coordinate the MIH Program's continuous quality assurance and improvement program. (B) Community EMS Programs. A Community EMS Program shall meet the following minimum standards of operation: (1) If a Community EMS Program's on-scene personnel, after assessment and in accordance with medical direction, determines that the patient is experiencing a medical emergency, the personnel shall activate the 911 EMS system and continue to assess and treat the patient in accordance with clinical protocols until transfer of care to the responding ambulance service in accordance with 105 CMR 170.355(B)(2) and (4) and the applicable service zone plan. (2) If a Community EMS Program deploys or intends to deploy a vehicle when responding to a Community EMS call or a scheduled home visit, such vehicle must be appropriate for the clinical encounter as approved by the Department. (3) Each Community EMS Program shall have written policies and procedures consistent with the requirements established in Department guidelines, accepted standards of care for the delivery of health care services and treatment, and applicable laws. 9/7/18 105 CMR - 1050.2

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.110 Complaints

173.110: Complaints (A) Upon receipt of any complaint or serious incident report, the Department shall take appropriate steps to investigate, as appropriate, whether the reported or alleged act or practice violates M.G.L. c. 111O, any provision of 105 CMR 173.000, any guidelines, or any condition imposed by the Department in its Certificate of Approval. The Department may also refer the complaint or serious incident report to the appropriate governmental authority responsible for licensure, certification, registration, approval, or oversight as deemed necessary. (B) If, after investigation, the Department finds that the act or practice violates M.G.L. c. 111O, any provision of 105 CMR 173.000, Department guideline, or any condition imposed by the Department in its Certificate of Approval, the Department may issue a correction order in accordance with 105 CMR 173.120 or an agency action in accordance with 105 CMR 173.090.

173.120 Inspections, Statement of Deficiency, Order to Correct

173.120: Inspections, Statement of Deficiency, Order to Correct (A) The Department, either announced or unannounced, may inspect any MIH or Community EMS Program for compliance with 105 CMR 173.000, Department guidelines, or conditions imposed by the Department in its Certificate of Approval. (B) Whenever the Department finds upon inspection or through information in its possession that an MIH or Community EMS Program is not in compliance, it may issue an order to correct the deficiency. The correction order shall include a statement of the deficiencies found, the provision of law relied upon, and a reasonable prescribed period for correction. (C) Within ten business days, an MIH or Community EMS Program shall submit to the Department a written plan of correction for each violation cited in the deficiency statement. (D) Every plan of correction shall set forth, with respect to each deficiency, the specific corrective step(s) to be taken, a timetable for such steps, and the date by which compliance will be achieved. The timetable and the compliance dates shall be consistent with achievement of compliance in the most expeditious manner possible. (E) The Department shall review the plan of correction for compliance and will notify the MIH or Community EMS Program whether the plan is accepted or rejected. (F) Upon expiration of the time specified for correction, the Department may re-inspect the MIH or Community EMS Program in order to determine whether it is in compliance with the correction order.

173.130 Summary Suspension of Certificate of Approval

173.130: Summary Suspension of Certificate of Approval (A) In accordance with 105 CMR 173.090, the Commissioner may summarily suspend an MIH or Community EMS Program Certificate of Approval, pending further proceedings for revocation of or refusal to renew a Certificate of Approval, whenever the Commissioner finds that the continued operation of such program poses an imminent threat to public health and safety. (B) The Department shall issue written notice of the suspension action which shall contain the reasons and grounds for immediate suspension, the provisions of law relied on, and an opportunity to request an adjudicatory hearing within 14 calendar days of receipt of the notice of the suspension action. (C) Upon receipt of a request for hearing within the time period prescribed by 105 CMR 173.090, the Department shall promptly afford the aggrieved party an opportunity for an adjudicatory hearing to be conducted by a designated hearing officer. If a hearing is not requested within the required time period, the right to a hearing shall be waived and a final agency decision shall issue. (D) Until the suspension is lifted or final agency determination is made, the MIH or Community EMS Program may not operate. 9/7/18 105 CMR - 1050.3

105 CMR: DEPARTMENT OF PUBLIC HEALTH

173.140 Waiver of Requirements

173.140: Waiver of Requirements (A) The Commissioner may waive the applicability of one or more of the requirements imposed on a particular MIH or Community EMS program by 105 CMR 173.000 if the Commissioner finds that: (1) Compliance would cause undue hardship; (2) The MIH or Community EMS Program's non-compliance would not adversely affect the quality of patient care or patient safety; (3) The MIH or Community EMS Program has instituted compensating features that are acceptable to the Department. (B) The MIH or Community EMS Program shall provide to the Commissioner written documentation supporting its request for a waiver.

173.150 Severability

173.150: Severability The provisions of 105 CMR 173.000 are severable. If a court of competent jurisdiction declares any section, subsection, paragraph, or provision unconstitutional or invalid, the validity of the remaining provisions shall not be affected. REGULATORY AUTHORITY 105 CMR 173.000: M.G.L. c. 111O and c. 111, § 3. 9/7/18 105 CMR - 1050.4