105 Mass. Reg. 140.020
The following terms as used in 105 CMR 140.000 shall be interpreted as follows, unless the context or subject matter clearly requires a different interpretation:
Ambulatory Surgery Center (ASC). An entity subject to licensure or licensed under M.G.L. c. 111, § 51 and 105 CMR 140.000 to provide surgical services.
Birth Center. A home-like facility where low risks births are planned to occur following normal, uncomplicated pregnancy.
Birth Center Services. Professional midwifery services provided to low risk childbearing women during pregnancy, birth, and puerperium and to the infant during the immediate newborn period by nurse-midwives or by obstetricians or family practitioners. Birth center services are provided in a free standing facility.
Certified Nurse Midwife. An individual authorized by the Board of Registration in Nursing under M.G.L. c. 112, § 80C and authorized to practice as a nurse-midwife pursuant to 244 CMR 4.00: Advanced Practice Registered Nursing.
CLIA. Clinical Laboratories Improvements Amendments and its implementing regulations set forth in 42 CFR 493.
Clinic. Any entity, however organized, whether conducted for profit or not for profit, is advertised, announced, established, or maintained for the purpose of providing ambulatory medical, surgical, dental, physical rehabilitation, or mental health services. In addition, clinic shall include any entity, however organized, whether conducted for profit or not for profit, advertised, announced, established, or maintained under a name includes the word clinic, "dispensary", or "institute", and suggests that ambulatory medical, surgical, dental, physical rehabilitation, or mental health services are rendered. With respect to any entity is not advertised, announced, established, or maintained under one of the names in the preceding sentence, Clinic shall not include a medical office building, or one or more practitioners engaged in a solo or group practice, whether conducted for profit or not for profit, and however organized, so long as such practice is wholly owned and controlled by one or more of the practitioners so associated, or, in the case of a not for profit organization, its only members are one or more of the practitioners so associated or a clinic established solely to provide service to employees or students of such corporation or institution. Notwithstanding the foregoing, Clinic shall include any entity certified or has applied for certification as an ambulatory surgery center by the Centers for Medicare and Medicaid Services for participation in the Medicare program. No matter how the clinic is named, clinic shall not include a clinic conducted by a hospital licensed under M.G.L. c. 111, § 51 or by the federal government, or the commonwealth. Clinic shall not include dental clinics operated by local schools and health departments for the sole purpose of providing education and dental hygiene services, including routine examinations, cleaning and topical fluoride applications. Clinic shall not include ad hoc health promotion and screening programs.
Clinic Pharmacy. A pharmacy not registered as a retail drug business pursuant to M.G.L. c. 112, § 39 and which is maintained and operated by a clinic.
Clinical Laboratory Services. The biological, serological, chemical, immunohematological, cytological, pathological, or other examinations of materials derived from a human body.
Commissioner. The Commissioner of the Massachusetts Department of Public Health or his or her designee.
Dentist. An individual registered by the Board of Registration in Dentistry under M.G.L. c. 112, § 45.
Department. The Massachusetts Department of Public Health.
Diagnostic Radiology. The use of ionizing radiation or ultrasonic procedures for diagnostic purposes only.
Host Site. The location off the premises of the clinic where a clinic provides mobile services.
Licensee. Any person holding a license to operate a clinic. In the case of a licensee that is not a natural person, Licensee shall also mean any shareholder owning 5% or more of any class of the outstanding stock of a privately-held corporation; any limited partner owning 5% or more of the partnership interests and any general partner of a partnership licensee; any trustee of any trust licensee; any sole proprietor of any licensee that is a sole proprietorship; any mortgagee in possession; and any executor or administrator of an estate of a licensee.
Mental Health. Any condition pertaining to mental health as defined by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders.
Mental Health Outreach Program. A mental health program, which may include treatment of cooccurring substance use disorder treatment, delivered off the premises of a clinic or any of its satellite clinics that provides services in patients' homes or other community environments, including practitioners' offices or community health centers defined as free-standing or hospital licensed community health centers licensed by the Department pursuant to M.G.L. c. 111, § 51.
For the purposes of 105 CMR 140.000, outreach services do not include patient visits to a practitioner's home or office.
Mobile Unit. A specially equipped, self-contained vehicle that may be driven, moved, towed or transported from one location to another, such as a van or trailer.
Mobile/Portable Unit. A mobile unit from which, from time to time, equipment and supplies may be removed to offer services at a location outside the mobile unit at which the clinic will provide licensed services. A Mobile/Portable Unit shall not mean a satellite of the clinic.
Notice of Intent Form. A form prescribed by the Department through which an applicant notifies the Department of its intent to acquire a clinic and/or to apply for a license to operate a clinic.
Nurse Practitioner. A registered nurse who holds authorization in advanced nursing practice as a nurse practitioner under M.G.L. c. 112, § 80B.
Nutritionist. A person who has an M.S. in public health nutrition, community nutrition, or human nutrition, from an accredited institution or who has a B.S. and is registered by the American Dietetic Association.
Physician. An individual registered by the Board of Registration in Medicine under M.G.L. c. 112, § 2 as a qualified physician.
Physician Assistant. A person who meets the requirements for registration set forth in M.G.L. c. 112, § 9I and who may provide medical services appropriate to his or her training, experience and skills under the supervision of a registered physician.
Podiatrist. An individual registered by the Board of Registration in Podiatry under M.G.L. c. 112, § 16.
Point-of-care Testing. The analysis of clinical specimens at the site of patient care, in order to provide immediate results to the health care provider. Examples of point-of-care tests include blood glucose tests, urine strip tests and other tests that do not require submission of the specimens to an outside laboratory.
Portable Unit. A vehicle that only transports equipment, supplies and/or personnel to a host site location at which the clinic will provide licensed services. A Portable Unit may be an extension/addition of services provided by a clinic with an existing licensed physical site, an addition/extension of services provided by a mobile unit, or a clinic that is exclusively portable, with no licensed physical site or mobile unit in which services are provided.
Practice. An enterprise involving the diagnosis or treatment of medical, surgical, dental, physical rehabilitation, or mental health problems. The supervision and direction of clinical staff, the assignment of patients to practitioners or other clinical staff, and the maintenance of patient records shall be deemed to be part of a practice. Billing and collection services, rental of space and rental of equipment shall also be considered part of a practice; however, the provision by a nonpractitioner of any one of these services to practitioner(s) shall not by itself mean such nonpractitioner shares in the control of the practice.
Practitioner. Any individual who holds a license, registration or authorization pursuant to M.G.L. c. 112 that authorizes the individual to diagnose and treat medical, surgical, dental, physical rehabilitation, or mental health problems within the scope of practice for his or her profession.
Primary Care Provider. A health care professional qualified to provide general medical care for common health care problems, who supervises, coordinates, prescribes or otherwise provides or proposes health care services, initiates referrals for specialist care and maintains continuity of care within the scope of practice.
Psychiatric Day Treatment Program. A specialized mental health program providing a planned combination of diagnostic, treatment, and rehabilitative services to individuals seeking treatment for mental health conditions, which may include co-occurring substance use disorder, who need more active or inclusive treatment than is typically available through a weekly visit to a mental health center or hospital outpatient department, but who do not need full-time hospitalization or institutionalization. Such a program utilizes multiple, intensive, and focused activities in a supportive environment to enable such persons to acquire more realistic, skillful, and effective behavior patterns, attitudes, and skills to support sustained independent functioning in the community. A clinic may provide psychiatric day treatment services only if it is licensed to provide mental health services.
Registered Nurse. An individual registered under M.G.L. c. 112, § 74.
Registered Pharmacist. An individual registered by the Board of Registration in Pharmacy pursuant to M.G.L. c. 112, § 24.
Satellite Clinic. A clinic operation off the premises of a clinic at which health services are provided, other than a mobile service. A Mental Health Outreach Program as defined in 105 CMR 140.020 shall not be considered a satellite clinic.
Social Worker. An individual who is currently licensed to practice social work in Massachusetts pursuant to M.G.L. c. 112, § 131 under the licensure categories of Licensed Independent Practitioner of Clinical Social Work, or Licensed Certified Social Worker.
Solo or Group Practice. The primary enterprise of the practitioner(s) as identified with the practitioner's licensing authority.
Specific Service. Any one of the following:
(1) Surgical Service. A service providing diagnosis or care through endoscopic procedures, or operative procedures requiring regional or general anesthesia.
(2) Dental Service. A service providing oral diagnostic, maintenance, preventive and restorative care and treatment to relieve dental pain and infection.
(3) Physical Rehabilitation Service. A service that provides physical restoration to physically handicapped and disabled persons through such therapies as physical therapy, occupational therapy and speech therapy.
(4) Mental Health Service. A separate, identifiable service providing diagnosis and treatment to individuals seeking treatment for mental health conditions, which may integrate treatment for co-occurring substance use disorder, and their families.
(5) Medical Service. A service providing diagnosis or treatment of illness or other medical services that are distinct from the services provided under 105 CMR 140.020: Specific Service (1) through (9).
(6) Mobile Service. A service providing diagnostic or treatment services through a mobile unit, a portable unit or a mobile/portable unit.
(7) Substance Use Disorder Treatment Service. A separate, identifiable service for individuals seeking treatment for substance use disorders which may integrate treatment for co-occurring mental health conditions.
(8) Birth Center Service. A service providing professional midwifery services to low risk childbearing women during pregnancy, birth, and puerperium, and to the infant during the immediate newborn period by nurse-midwives or by obstetricians or family practitioners.
(9) Limited Services. Diagnosis, treatment, management and monitoring of acute and chronic disease, wellness and preventive services of a nature that may be provided within the scope of practice of a nurse practitioner using available facilities and equipment, including shared toilet facilities for point-of-care testing. Limited Services shall not mean surgical services, dental services, physical rehabilitation services, mental health services, substance use disorder services, or birth center services as defined in 105 CMR 140.020: Specific Service (1) through (8), which require a separate licensure designation.
Substance Use Disorder. Any condition pertaining to substance use disorder as defined by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders.
Transfer of Ownership. Includes, but not be limited to, the following transfers:
(1) a transfer of a majority interest in the ownership of a clinic;
(2) in the case of a privately-held for-profit corporation, transfer of a majority of any class of the stock thereof;
(3) in the case of a partnership, transfer of a majority of the partnership interest;
(4) in the case of a trust, change of the trustee or a majority of trustees; or
(5) in the case of a nonprofit corporation, such changes in the corporate membership and/or trustees as the Department determines to constitute a shift in control of the clinic.
Transfer of Ownership also means any change in the ownership interest or structure of the clinic or the clinic's organization or parent organization(s) that the Commissioner determines to effect a change in control of the operation of the clinic. A transfer of ownership shall also be deemed to have occurred where foreclosure proceedings have been instituted by a mortgagee in possession. The Commissioner may, in his or her discretion, determine a proposed transaction does not rise to the level of a transfer of ownership.
Urgent Care. Delivery of episodic care for the diagnosis, treatment, management or monitoring of acute and chronic disease or injury that is:
(1) for the treatment of illness or injury that is immediate in nature, but does not require emergency services;
(2) generally provided on a walk-in basis without prior appointment; and
(3) available to the general public; and not intended as the patient's primary care provider. Urgent Care shall not mean surgical services, dental services, physical rehabilitation services, mental health services, substance use disorder services, birth center services or limited services as defined in 105 CMR 140.020: Specific Service (1) through (9), which require a separate licensure designation; or Emergency Service or Satellite Emergency Facility as defined in 105 CMR 130.020: Hospital Licensure.
105 CMR 140.020