105 C.M.R. 100.100
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)
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:
(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:
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:
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:
(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:
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.
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:
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:
Location or Premises means:
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:
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:
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:
(2) For any Health Care Facility other than a Hospital:
Substantial and Continuing Progress means:
(2) In the case of a project involving the provision of a DoN-required Service or DoN-required Equipment, either:
(5) In the case of a project involving Construction, the following shall have occurred:
Sufficient Interest means one of the following:
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:
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:
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.