105 CMR 100.100
Definitions
As used in 105 CMR 100.000, the following terms have the following meanings unless
otherwise interpreted by the Department:
Addition means:
(1) The initial provision of a DoN-required Service or procedure, or acquisition of medical
equipment defined as DoN-required Equipment; or
(MA REG. # 1381, Dated 12-28-18)
(2) The initial provision of any services that may be provided by a Health Care Facility,
including, but not limited to, a change from a single specialty to a multi-specialty
Freestanding Ambulatory Surgery Center.
Affiliate. Any relationship between two organizations that reflects, directly or indirectly, a
partial or complete controlling interest or partial or complete common control.
Ambulatory Surgery. Health care services restricted to those defined by the Department as
surgical services, not requiring overnight stay, typically provided to ambulatory patients on an
elective, urgent, or emergency basis, wherever provided.
Applicant. The Provider Organization that files the Application for Determination of Need with
the Department for, or on behalf of, the Entity seeking a Notice of Determination of Need for a
Proposed Project pursuant to 105 CMR 100.000. In instances where there is no Provider
Organization, Applicant shall mean the Entity which files the Application for Determination of
Need with the Department for itself or, on behalf of, an Affiliate seeking a Notice of
Determination of Need for a Proposed Project pursuant to 105 CMR 100.000.
Application. A formal written request for a Determination of Need, submitted to the Department
pursuant to 105 CMR 100.405.
Attorney General or AGO. The Massachusetts Attorney General or his or her designee. For the
purposes of 105 CMR 100.000, the Attorney General may intervene in any hearing regarding an
Application for Determination of Need, whether or not the Attorney General requested the
hearing, by providing written notification of such intervention to the Department.
Bed Capacity. The capacity of a Health Care Facility to accommodate a bed and the necessary
physical plant requirements, in accordance with all applicable standards, imposed as a condition
of operation pursuant to all federal and state laws and regulations.
Capital Expenditure means:
(1) Any expenditure, or obligation to make an expenditure, past, present or future, which,
under generally accepted accounting principles, is not properly chargeable as a cost of
operation and maintenance, and which includes any fee(s) for architectural, engineering,
legal, accounting, or any other professional services, any interest charges, and any other
financing cost capitalized throughout the Construction period of the project, and any Site
acquisition cost(s); or
(2) Any expenditure or obligation to make an expenditure, past, present, or future, for
obtaining by lease, or comparable arrangement, capital equipment, or a building or part
thereof; provided, that in both cases, such expenditure or obligation is incurred, or will be
incurred, as an incident to Construction as defined in 105 CMR 100.100.
Every calculation of a Capital Expenditure must take into account all expenditures related
to a Proposed Project. All calculations shall be based on costs as of the Application Filing
Date, assuming Construction commenced on that date, with no inclusion of estimates
regarding inflation. Calculations shall be subject, but are not limited, to the following
parameters:
(a) In calculating a Capital Expenditure, Applicants shall account for all expected future
expenditures in connection with a Proposed Project, as well as any past or present
expenditures necessary for a Proposed Project's completion including, but not limited to:
the purchase price of an earlier acquired Site; expenses related to completion of
feasibility or other planning studies used in developing a project or preparing an
Application; expenses incurred in seeking grants, loans, or other financing; legal or
consultant fees; and, any other such expenditures which can be reasonably attributed to
the completion of a Proposed Project.
(b)
Where Construction is to be undertaken on leased property, or where leased
equipment is to be installed, the fair market value of such property or equipment, as
appropriate and in conformance with the terms of M.G.L. c. 111, § 25B, shall be used in
calculating the proposed Capital Expenditure attributed to such property or equipment.
See 105 CMR 100.100: Substantial Capital Expenditure.
Center for Health Information and Analysis or CHIA. The Government Agency established
pursuant to M.G.L. c. 12C.
Certified ACO. An Entity which is certified by the HPC as an accountable care organization
pursuant to M.G.L. c. 6D, § 15 and which meets the HPC's Final Accountable Care Organization
(ACO) Certification Standards.
Clinic. An Entity licensed by the Department pursuant to 105 CMR 140.000: Licensure of
Clinics.
Commissioner. The Commissioner of Public Health or his or her designee.
Conditions. All terms and Conditions, both Standard and Other, included in a Notice of
Determination of Need issued by the Department.
Conservation Project. Construction that consists solely of a project(s) that would Sustain or
Restore a Health Care Facility or service for its designated purpose, and to its original
functionality, without Modernization, Addition, or Expansion. For the purposes of Conservation
Project, the following words shall mean:
(1) Sustain. The maintenance and repair activities necessary to keep a Health Care Facility
or service in good working order. It includes regularly scheduled adjustments and
inspections, preventive maintenance tasks, and emergency response and service calls for
minor repairs. It also includes major repairs or replacement of facility components that are
expected to occur periodically throughout the life cycle of said Health Care Facility or
service. This work includes, but is not limited to, regular roof replacement, refinishing of
wall surfaces, repairing and replacement of heating and cooling systems, replacing tile and
carpeting, and similar types of work. It does not include environmental compliance costs,
facility leases, or other tasks associated with facilities operations, such as custodial services,
grounds services, waste disposal, and the provision of central utilities.
(2) Restore. To return a Health Care Facility or service to such a condition that it may be
used for its designated purpose or to, but not beyond, restore the Health Care Facility or
service's original functionality. This may include coming into compliance with all applicable
federal, state, and local licensure, safety, and building requirements including nationally
recognized Health Care facility construction guidelines and accreditation standards, such as
those issued by the Facility Guidelines Institute, the American Institute of Architects, or the
Joint Commission.
(3) Modernization. The alteration, Addition, Expansion, or replacement of all, or part, of
a Health Care Facility or service to accommodate new or increased functionality, or to
replace components of a Health Care Facility or service beyond that necessary to Sustain or
Restore said facility or service.
Construction. The Construction of a new Health Care Facility; the alteration of, Expansion of,
making of major repairs to, remodeling of, renovation of, or replacement of an existing Health
Care Facility; the initial, additional, or replacement equipping of any Health Care Facility; and
the acquisition of consulting, architectural, engineering, legal, accounting, or any other
professional services, and of a Site, when such acquisition is directed toward an undertaking
sufficiently specific to constitute part of the subject matter of an Application for Determination
of Need pursuant to 105 CMR 100.000.
Conversion. The substitution of a service or equipment that is defined as a Substantial Change
in Service by the Department, in place of a current service or equipment.
Department. The Department of Public Health, which shall include the Public Health Council,
pursuant to M.G.L. c. 17, § 1, except as otherwise specified.
Department Staff. Employees or agents acting on behalf of the Commissioner or the Department
including, but not limited to, consultants hired to support staff review and staff report
development of an Application for Determination of Need.
Determination of Need Process. The process by which the Department reviews and evaluates
the need for a Proposed Project pursuant to M.G.L. c. 111, §§ 25B through 25G, §§ 51 through
53, and § 71, or any applicable Government Agency requirement.
DoN-required Service. A service or procedure that for reasons of quality, access, cost, or health
systems sustainability is determined by the Commissioner to require a Notice of Determination
of Need. At a minimum, DoN-required Services shall include services or procedures for which
the Commissioner has determined that there is evidence that the service(s) or procedure(s) do
not lead to one or more of the following: improved Patient Panel health outcomes; increased
access including, but not limited to, a decrease in price; or, a reduction in the Commonwealth's
Total Health Care Expenditure. The Commissioner shall issue a list of DoN-required Services
in the form of Guidelines. Said Guidelines shall be reviewed and evaluated annually. Persons
may submit to the Commissioner requests that a certain service(s) or procedure(s) be considered
for inclusion or exclusion from said Guidelines.
DoN-required Equipment. Equipment or services that for reasons of quality, access, cost, or
health systems sustainability is determined by the Commissioner to require a Notice of
Determination of Need. At a minimum, DoN-required Equipment shall include magnetic
resonance imagers and linear accelerators, as well as any equipment and services for which the
Commissioner has determined that there is evidence that the equipment or service(s) do not lead
to one or more of the following: improved Patient Panel health outcomes; increased access
including, but not limited to, a decrease in price; or, a reduction in the Commonwealth's Total
Health Care Expenditure. The Commissioner shall issue a list of DoN-required Equipment in
the form of Guidelines. Said Guidelines shall be reviewed and evaluated annually. Persons may
submit to the Commissioner, requests that certain equipment or service(s) be considered for
inclusion or exclusion from said Guidelines.
Emergency Situation. A situation involving either:
(1) a Government Declaration of emergency or a Catastrophic Event; or
an existing Health Care Facility which the Commissioner determines has been
destroyed, or otherwise substantially damaged, or where there is a clear and present danger
of such damage, such that the damage could substantially impact public health. For the
purposes of Emergency Situation, the following words shall mean:
(a) Government Declaration. A federal, state, municipal, or local declaration of
emergency that takes effect pursuant to applicable federal or state law.
(b) Catastrophic Event. An unforeseen event that substantially affects or increases the
need for health care services, such as a natural disaster, an act of terrorism, or an
extended power outage. Examples of Catastrophic Events include, but are not limited
to, events involving numerous serious injuries, such as fires or building collapse, a
chemical spill or release, or widespread outbreak of disease or illness requiring
emergency treatment or hospitalization.
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.
Expansion. Any increase or upgrade by a Health Care Facility to the existing functionality of
a DoN-required Service or DoN-required Equipment; any increase or upgrade to the total number
of beds, services, or stations; or any other change as further defined by the Department.
Expenditure Minimum.
(1) Expenditure Minimum with Respect to Substantial Capital Expenditures. Expenditure
Minimum with Respect to Substantial Capital Expenditures as defined in M.G.L. c. 111,
§ 25B, and that is adjusted annually by the Commissioner after consideration of any inflation
index established by the U.S. Department of Health and Human Services or similarly reliable
national index, and set forth by the Commissioner in a Guideline.
(2) Expenditure Minimum with Regard to Substantial Change in Service or Increase in
Staff. Expenditure Minimum with Regard to Substantial Change in Service or Increase in
Staff as defined in M.G.L. c. 111, § 25B, and that is adjusted annually by the Commissioner
after consideration of any inflation index established by the U.S. Department of Health and
Human Services or similarly reliable national index, and set forth by the Commissioner in
a Guideline.
Notwithstanding 105 CMR 100.100: Expenditure Minimum(1) and (2), a Proposed Project
concerned solely with outpatient services other than Ambulatory Surgery, which are not
otherwise defined as DoN-required Service or DoN-required Equipment, shall not require a
Notice of Determination of Need, unless the expenditures and acquisitions are at least the
amount that is adjusted annually by the Department after consideration of any inflation index
established by the U.S. Department of Health and Human Services or similarly reliable national
index, in which case, a Notice of Determination of Need shall be required.
Notwithstanding 105 CMR 100.100: Expenditure Minimum(1) and (2), expenditures for,
or the acquisition of, any replacement of medical, diagnostic, or therapeutic equipment defined
as a DoN-required Service or DoN-required Equipment for which a Notice of Determination of
Need was previously issued, or for which the DoN-required Service or DoN-required Equipment
was exempt from Determination of Need, shall not require an additional Notice of
Determination of Need, and shall not be included in the calculation of the Expenditure
Minimum, so long as the project(s) falls within the definition of a Conservation Project as
determined by the Department.
Factor or Determination of Need Factor. Each of the standard requirements for evaluation of an
Application for Determination of Need as established within 105 CMR 100.000.
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Federal Fiscal Year. A 12-month period that starts on October 1 and ends on September 30 .
Filing Date. The date at which an Application for Determination of Need is deemed, by
Department Staff, to be substantially complete and thus filed with the Department by an
Applicant. The Filing and Submission Dates may be the same.
Final Action. Unless otherwise specified, the issuance of a Notice of Determination of Need,
approval, disapproval or dismissal of an Application or request to amend a previously issued
Notice of Determination of Need, or revocation of a Notice of Determination of Need by the
Department or Commissioner.
Freestanding Ambulatory Surgery Center. An ambulatory surgery center licensed as a Clinic.
Good Cause Related to Project Implementation. The Applicant is unable to make Substantial
and Continuing Progress within the period of the Notice of Determination of Need authorization
due to:
Unreasonably excessive delay on the part of the Department in processing any
Application or request;
(2) Force majeure (e.g., a government declaration, catastrophic event, labor strike, or other
cause beyond the control of the Applicant and/or the Department that could not be reasonably
avoided by the Applicant's exercise of due care);
(3) Action of general application by any branch of federal, state, or local government;
(4) Winter conditions that preclude making Substantial and Continuing Progress toward
completion, provided that the Applicant would have made such Substantial and Continuing
Progress within the period of authorization, but for such winter conditions;
(5) Failure to obtain a financing commitment, provided that, within the period of the Notice
of Determination of Need authorization, the Applicant has filed a firm commitment
application with the United States Department of Housing and Urban Development or
successor agency, in which case, the period of the Notice of Determination of Need
authorization shall be extended for a period of not more than four months beyond the period
authorized; or
(6) Any other condition that may be specified by the Department; and
The Applicant is able to demonstrate to the Department that the project is diligently
proceeding with the completion of all prerequisites to making Substantial and Continuing
Progress within the period of the Notice of Determination of Need authorization.
Good Cause Related to Project Implementation shall exclude Transfer of Ownership; transfer
of Site; failure to obtain financing commitments under circumstances other than those described
within 105 CMR 100.100: Good Cause Related to Project Implementation(5); an action taken
by a Person related to zoning that has, or may have, the effect of limiting the Applicant's
development rights with respect to a Site(s) in one city or town; and, any other reason deemed
as applicable by the Department.
Government Agency. Any agency of the Commonwealth of Massachusetts or of any political
subdivision of the Commonwealth of Massachusetts therein, including a city or a town, but does
not mean an agency of the United States, even if such agency maintains a medical institution
within Massachusetts.
Guideline. An enforceable sub-regulatory requirement that has been issued by the Commissioner
pursuant to 105 CMR 100.000, but not promulgated as regulation. The Commissioner shall
ensure that prior to issuance, all Guidelines have been put forth for public comment. The
Commissioner shall notify the Public Health Council of any Guideline issued by the Department
within 60 days of issuance.
Health Care Facility. A Hospital or a Clinic; a Long-term Care Facility; a clinical laboratory
subject to licensure under M.G.L. c. 111D; a Public Medical Institution as defined in 105 CMR
100.100; or any other facility licensed by a Government Agency which requires a Notice of
Determination of Need as a condition of licensure or other Government Agency requirement.
Health Policy Commission or HPC.
The Government Agency established pursuant to
M.G.L. c. 6D.
Health Priorities. Services or population health strategies that address identified regional, or
statewide public health needs. Health Priorities shall be defined by the Commissioner in
Guidelines and developed in consultation with relevant Government Agencies, community-based
organizations, stakeholders, and the Public Health Council, may be guided by the state health
plan pursuant to M.G.L. c. 6A, §16T and relevant community health needs assessments, and shall
encourage the appropriate allocation of private and public health care resources consistent with
M.G.L. c. 111, § 25C.
Holder. The Provider Organization which has been issued a Notice of Determination of Need
by the Department pursuant to 105 CMR 100.000. In instances where there is no Provider
Organization, Holder shall mean the Entity which has been issued a Notice of Determination of
Need by the Department pursuant to 105 CMR 100.000.
Hospital. Any hospital licensed pursuant to M.G.L. c. 111, § 51.
Immaterial Change means:
An increase or decrease in cost allocation among or between architectural costs,
Construction contract, fixed equipment, and Site services that does not result in any increase
in the maximum Capital Expenditure;
(2) A change in the proposed method of financing that does not result in any increase in the
maximum Capital Expenditure or operating costs for interest in any year;
(3) A change in the maximum Capital Expenditure to the extent of the inflation adjustment
provided for within 105 CMR 100.310(A)(9);
(4) For all Health Care Facilities other than Hospitals, a single increase, or cumulative series
of increases, in Bed Capacity totaling not more than 12 beds to the licensed Bed Capacity of
the entire Health Care Facility;
(5) A change in the architectural design that does not result in any changes in the spatial
allocation among different components of the project, aggregate gross square footage, Bed
Capacity, or maximum Capital Expenditure. Any such change in the architectural design
shall be subject to the Department's architectural plan approval as provided for within
105 CMR 100.310(A)(6);
(6) An increase or decrease in the spatial allocation among different components of the
project or the aggregate gross square footage of the project, provided that any such change
does not result in any change in the Bed Capacity or any increase or decrease in the
maximum Capital Expenditure over 10% of the inflation adjusted originally approved total
expenditure, unless otherwise approved hereunder. Any such increase or decrease in the
spatial allocation of the project's components or aggregate gross square footage of the project
shall be subject to the Department's architectural plan approval as provided for in 105 CMR
100.310(6);
(7) Any increase or decrease in the maximum Capital Expenditure less than or equal to 10%
of the inflation adjusted originally approved total expenditure. An increase shall be allowed
only for contingencies that could not have been reasonably foreseen, that are not reasonably
within the control of the Holder, as determined by the Commissioner, and for which the
inflationary adjustment contained within 105 CMR 100.310(A)(9) is not appropriate;
(8) Any change in the type of equipment which the Commissioner determines not to be
technologically different from that which received Notice of Determination of Need,
provided that such a change does not result in any increase in the maximum Capital
Expenditure, unless otherwise approved hereunder, or any increase in the likely operating
costs; or
(9) Any alteration from the previously issued Notice of Determination of Need that the
Commissioner determines to be an Immaterial Change in nature.
Location or Premises means:
(1) The street address(es) of the Health Care Facility; and
(2) In the case of a Health Care Facility located within a physically contiguous campus of
an institution such as a school, university or Hospital, Location or Premises shall mean the
campus.
Long-term Care Facility. A long-term care facility, including a convalescent or nursing home,
or a rest home as defined in M.G.L. c. 111, § 71.
Notice of Determination of Need or Notice. A Final Action that represents the formal approval
of the Department issued pursuant to 105 CMR 100.000. A Notice of Determination of Need
shall include all applicable terms and Conditions, Standard or Other, as directed and attached to
the Notice of Determination of Need by the Department.
Original License. The license issued to a Person for the Premises named therein, and is granted
either upon initial licensure of a facility, change of Location, or Transfer of Ownership of a
Health Care Facility.
Patient Panel. The total of the individual patients regardless of payer, including those patients
seen within an emergency department(s) if applicable, seen over the course of the most recent
complete 36-month period by the Applicant or Holder. Patient Panel also means:
(1) If the Applicant or Holder has no patient panel itself, the Patient Panel includes the
Patient Panel of the health care facilities affiliated with the Applicant; or
(2) If the Proposed Project is for a new facility and there is no existing patient panel, Patient
Panel means the anticipated patients; or
(3) In the case of a Transfer of Ownership, Patient Panel also includes the Patient Panel of
the Entity to be acquired.
Party of Record. During the pendency of an Application for a Determination of Need, the
Applicant or Holder, the Attorney General, CHIA, HPC, all Government Agencies with relevant
oversight or licensure authority over the Proposed Project or components therein, and any Ten
Taxpayer Groups duly registered. A Party of Record may review the Application for
Determination of Need for which it is appropriately registered, as well as provide written
comment for consideration by the Department, including written comment by the Attorney
General, CHIA, and HPC as it relates to any independent cost-analyses made pursuant to
105 CMR 100.405.
Primary Service Area. The geographic area in which a majority of patients who receive care at
a Health Care Facility reside. The percentage of patients who are counted in determining the
Primary Service Area will be set out in Guideline.
Proposed Project. Any Substantial Capital Expenditure, Substantial Change in Service
including, but not limited to, DoN-required Service, DoN-required Equipment, Ambulatory
Surgery, or any combination thereof; or Any Original License or Transfer of Ownership that is
proposed within an Application for Determination of Need and filed with the Department
pursuant to 105 CMR 100.000. A Proposed Project may include an Applicant’s institutional
master plan.
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 and is the sole corporate member or sole shareholder of one or more Health
Care Facilities.
Public Medical Institution. Any medical institution, including an institution for the mentally ill
or for individuals with intellectual disabilities, supported in whole or in part by public funds,
either federal, state, or municipal, and staffed by professional medical and nursing personnel and
providing medical care in accordance with standards established through licensure, approval, or
certification by the Department for participation in programs administered under Titles XVIII
or XIX of the Federal Social Security Act.
Significant Change means:
(1) Any change, modification, or deletion of components within a previously issued Notice
of Determination of Need that is not an Immaterial Change, as determined by the
Commissioner;
(2) Any increase or decrease in the maximum Capital Expenditure over 10% of the inflation
adjusted originally approved total expenditure. An increase shall be allowed only for
contingencies that could not have been reasonably foreseen, that are not reasonably within
the control of the Holder, as determined by the Commissioner, and for which the inflationary
adjustment contained within 105 CMR 100.310(A)(9) is not appropriate;
(3) Any request for modification or deletion of any Standard or Other condition set forth
within a Notice of Determination of Need that is determined to be material by the
Department;
(4) Unless otherwise approved by the Department, any extension of the authorization period
of an approved project as specified in a Notice of Determination of Need; or
(5) Any build-out of shell space that was subject to a Notice of Determination of Need.
Any change to a project the Commissioner deems to be so significant that it alters the
previously issued Notice of Determination of Need to a degree that it constitutes a new project
will require the issuance of a new Notice of Determination of Need.
Site. Land and any building or part thereof.
Solicitation of Funding. The act of approaching any member of the general public with a request
or plea for a donation of funds to be used for a Proposed Project. For such purposes, Solicitation
of Funding shall exclude ongoing Solicitation of Funding conducted on behalf of the Applicant
and not directly related to the Proposed Project.
Submission Date. The date at which an Application is for Determination of Need is first
submitted to the Department Staff. The Filing and Submission Dates may be the same.
Substantial Capital Expenditure. Capital Expenditures that exceed, or may reasonably be
regarded as likely to exceed, the Expenditure Minimum. Substantial Capital Expenditure shall
also mean the obtaining of capital equipment or a building, or part thereof, by lease or
comparable arrangement, by donation, or by transfer for less than fair market value in excess of
the Expenditure Minimum. The fair market value of a lease of equipment or a building, or part
thereof, shall be equal to its fair market value were it to be purchased. See 105 CMR