Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.100 - Definitions

Current through Register 1525, July 5, 2024
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
(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
(2) 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.
Federal Fiscal Year
. A 12-month period
				that starts on October 1st and ends on September
				30th.
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:
(1) 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:
(1) 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 100.100:
Capital Expenditure
and
Expenditure
				Minimum
.
Substantial Change in Services
means:
(1) With regard to Hospitals only, the Addition or Expansion
				of, or Conversion to:
(a) A DoN-required Service, DoN-required Equipment, or
				Ambulatory Surgery, regardless of whether an Expenditure Minimum is exceeded;
				or
(b) Any services that may be provided by facilities that are
				not Hospitals.
(2) For any Health Care Facility other than a Hospital:
(a) The Addition of a service or increase in staff that entails
				annual operating costs in excess of the Expenditure Minimum;
(b) Any increase in Bed Capacity, other than a single increase,
				or cumulative series of increases, totaling not more than 12 beds to the
				licensed Bed Capacity of the entire Health Care Facility;
(c) The Addition or Expansion of, or Conversion to, a
				DoN-required Service or DoN-required Equipment regardless of whether an
				Expenditure Minimum is exceeded;
(d) The Addition or Expansion of, or Conversion to, Ambulatory
				Surgery; or
(e) Upgrading Level IV beds to skilled nursing and intermediate
				care beds (Level II and III).
(3) A transfer of Site of any Health Care Facility,
				DoN-required Service, DoN-required Equipment, or a project which has been
				previously issued a Notice of Determination of Need but is not yet licensed, or
				not yet operational if no Government Agency license, that is determined by the
				Department to result in a Substantial Change in Service.
Substantial and Continuing Progress
means:
(1) In the case of a project involving equipping of a Health
				Care Facility, such equipment shall have been installed and shall be
				operational;
(2) In the case of a project involving the provision of a
				DoN-required Service or DoN-required Equipment, either:
(a) provision of such service or use of such equipment shall
				have commenced; or
(b) demonstration of a binding contract for the purchase or
				lease of the equipment with a party unrelated to the Holder or ultimate
				provider of the DoN-required Service or DoN-required Equipment;
(3) In the case of a project involving the provision of a
				DoN-required Service or DoN-required Equipment subject to Department licensure,
				the project shall have received written, final plan approval from the
				Department;
(4) In the case of a project involving an increase in the Bed
				Capacity, or licensed Bed Capacity of a Health Care Facility, or a service or
				unit thereof, but involving no Construction or renovation, a request for an
				increase in the Health Care Facility's licensed capacity for such beds shall
				have been submitted to the Department; however, if not required to be so
				licensed, such beds shall be in operation;
(5) In the case of a project involving Construction, the
				following shall have occurred:
(a) commencement of demolition and the physical assembly of the
				foundation of the project for Construction and ground floor Addition projects
				when a foundation is part of the project;
(b) commencement of the physical assembly of the additional
				structure; or
(6) In the case of a project involving renovation, progress
				beyond the removal and demolition of an existing facility, or of the component
				structures of an existing facility.
Sufficient Interest
means one of the
				following:
(1) Clear legal title to the proposed Site, or a legally
				enforceable agreement to give such title;
(2) In the case of a Hospital or Long-term Care Facility, a
				lease for at least five years with options to renew for not less than a total
				of 15 additional years, or a legally enforceable agreement to give such
				lease;
(3) In the case of an Ambulatory Surgery center, a lease for at
				least one year with options to renew for not less than one additional year, or
				a legally enforceable agreement to give such lease;
(4) In the case of a Clinic organized as a non-profit
				corporation under M.G.L. c. 180, permission to use the Premises for a period of
				at least two years; or
(5) In the case of a Government Agency, recommendation of not
				more than four alternative Sites by an official Site selection committee and
				acceptance of that recommendation by the duly elected or appointed chief
				officer of that Government Agency and, in the case of a Government Agency
				within an executive office, acceptance of that recommendation by the Secretary
				of that executive office.
Taxpayer
. Any individual residing
				within the Commonwealth of Massachusetts and who is subject to any
				Massachusetts state income, excise, or property tax during the calendar year in
				which he or she signs a written request for a public hearing, a statement of
				registration, or comments with respect to an Application filed pursuant to
				105 CMR
				100.000.
Ten Taxpayer Group
. Any ten Taxpayers,
				organized as a group, which may participate in the review of an Application for
				Determination of Need or request to amend a previously issued Notice of
				Determination of Need. Said group must register with the Department at any time
				during the first 30 days following the Filing Date of an Application, or during
				the first ten days after a public hearing held pursuant to
				105 CMR 100.445.
				Any such registration shall be signed by each Taxpayer and shall, in clearly
				legible print:
(1) List each Taxpayer by name and resident address;
(2) State whether or not each Taxpayer is acting as an agent
				for another party. If a Taxpayer is acting as an agent for another party, the
				Taxpayer must list that party's full name and address;
(3) Identify the Application in which the Taxpayers are
				interested; and
(4) Specify which Taxpayer is to be the recipient of all
				written communications concerning the Application on behalf of the Ten Taxpayer
				Group.
Upon receipt of any such registration, Department Staff shall
				promptly send a copy to each Party of Record. The Commissioner may revoke the
				Ten Taxpayer Group status of any group that has failed to comply with the
				requirements of
				105 CMR
				100.000.
Total Value
. The sum of the total
				Capital Expenditure of a Proposed Project; or in the case of a Transfer of
				Ownership pursuant to
				105 CMR
				100.735, the total capital value or the last
				full year of reported net patient service revenue, whichever is greater, of the
				proposed facility or facilities to be acquired at the time of the Filing
				Date.
Transfer of Ownership
shall include,
				but shall not be limited to, the following:
(1) A transfer of a majority interest in the ownership of a
				Hospital or 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
				trustees;
(4) In the case of a trust, change of the trustee or a majority
				of trustees;
(5) In the case of a nonprofit corporation, such changes in the
				corporate membership and/or trustees to constitute a shift in control of the
				Hospital or Clinic as determined by the Commissioner; or
(6) In the case where foreclosure proceedings have been
				instituted by a mortgagee in possession of a Hospital or Clinic.
For the purposes of
				105 CMR
				100.000,
Transfer of
				Ownership
may also mean any change in the ownership interest or
				structure of the Hospital or Clinic, or of the Hospital or Clinic's
				organization or parent organization(s), such that the change results in a shift
				in control of the operation of the Hospital or Clinic, as determined by the
				Commissioner. The Commissioner may, based upon a review of the organizational
				structure and proposed change, determine that a proposed transaction does not
				rise to the level of a Transfer of Ownership.