Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 100.000 - Determination of Need › Section 100.310 - Standard Conditions

Current through Register 1525, July 5, 2024
(A)
Applicability
. Unless otherwise expressly specified
			 within 105 CMR 100.000, each Notice of Determination of Need issued by the
			 Department shall be subject to the following Conditions. The Commissioner may
			 specify additional Standard Conditions through Guideline which shall be
			 attached to all Notices of Determination of Need, unless otherwise specified,
			 and which shall be determined by the Commissioner as advancing the objectives
			 of 105 CMR 100.000. Prior to issuance, such Guideline shall be developed
			 through a public process that includes consultation with applicable Government
			 Agencies, community-based organizations, relevant stakeholders, and the Public
			 Health Council.
(1) The Notice of
			 Determination of Need shall be subject to administrative review by the Health
			 Facilities Appeals Board and may be stayed by the Health Facilities Appeals
			 Board. If the Health Facilities Appeals Board is not constituted on the date of
			 issuance of the Notice of Determination of Need, the Notice shall be considered
			 a Final Action subject to review under M.G.L. c. 30A.
(2) The Notice of Determination of Need shall
			 go into effect upon the Department's issuance of a written notification made
			 pursuant to
			 105 CMR
			 100.625(A). The Holder shall
			 submit an acknowledgment of receipt to the Department within 30 days of the
			 written notification, signed by the Holder's chief executive officer and board
			 chair, and returned to the Department and all Parties of Record. Unless
			 extended for Good Cause Related to Project Implementation, or as a result of an
			 approved amendment to a previously issued Notice of Determination of Need, the
			 Notice of Determination of Need shall constitute a valid authorization for a
			 period of not more than three years following the approval of the Department,
			 unless otherwise expressly noted as an Other Condition, and shall only be for
			 the purposes of the approved project, including for the identified and approved
			 treatments and/or patient populations. No Notice of Determination of Need shall
			 remain in authorization unless the Holder complies with all prescribed terms
			 and Conditions set forth by the Department. Any Notice of Determination of Need
			 issued to a Holder that is subject to a Cost and Market Impact Review pursuant
			 to M.G.L. c. 6D, § 13 and 958 CMR 7.00:
Notices of Material Change
			 and Cost and Market Impact Reviews
shall not go into effect until 30
			 days following HPC's completed Cost and Market Impact Review.
(3) Unless extended for Good Cause Related to
			 Project Implementation, or as a result of an approved amendment to a previously
			 issued Notice of Determination of Need, the Notice of Determination of Need
			 shall constitute a valid authorization only for the Proposed Project for which
			 the Notice of Determination of Need is made, and for only the total Capital
			 Expenditure approved.
(4) The
			 Notice of Determination of Need shall constitute a valid authorization only for
			 the Person to whom it is issued and may be transferred only upon the expressed
			 written permission of the Department pursuant to
			 105 CMR
			 100.635(A), except that:
(a) the Holder of a Notice of Determination
			 of Need for a Transfer of Ownership issued pursuant to
			 105 CMR
			 100.735 becomes the Holder of any Notice of
			 Determination of Need then held by any entity being transferred;
(b) for any Transfer of Ownership not subject
			 to
			 105 CMR
			 100.735, where the Health Care Facility being
			 acquired is the Holder of a Notice of Determination of Need which is still in
			 effect pursuant to
			 105 CMR
			 100.310(17), the transferee
			 must provide Notice to the Department in a form and manner determined by the
			 Commissioner that it will assume all obligations and comply with all Conditions
			 and requirements of such Notice of Determination of Need; and
(c) for any Transfer of Ownership not subject
			 to
			 105 CMR
			 100.735 where the Health Care Facility being
			 acquired is the Holder of an unimplemented Notice of Determination of Need
			 issued before January 27, 2017, at the time that a license is issued to the
			 transferee, pursuant to 105 CMR 153.000:
Licensure Procedure and
			 Suitability Requirements for Long-term Care Facilities,
the transferee
			 becomes the Holder of any Notice of Determination of Need then held by any
			 entity being acquired. Following the transfer, the Holder may implement the
			 Notice of Determination of Need as approved, unless implementation requires any
			 Significant Change, in which case the Holder must comply with the requirements
			 of
			 105 CMR
			 100.635.
Notwithstanding the exceptions above, a Notice of Determination
				of Need issued for an Original License pursuant to
				105 CMR
				100.730 and a Notice of Determination of Need
				for a Transfer of Ownership pursuant to
				105 CMR
				100.735 shall not be
				transferable.
(5)
			 The authorization for the Notice of Determination of Need shall expire if the
			 Department determines that Substantial and Continuing Progress is not made, or
			 if not duly extended by the Department for Good Cause Related to Project
			 Implementation shown. Any request for an extension must be filed by the Holder
			 within the period of authorization for the Notice of Determination of Need. In
			 the event an appeal is filed with the Health Facilities Appeals Board, the
			 period of authorization of the Notice of Determination of Need shall be
			 extended during such time that any stay is in effect.
(6)
(a)
			 Notwithstanding the period of authorization of the Notice of Determination of
			 Need, if the Holder is subject to the requirements of filing final
			 architectural plans and specifications pursuant to M.G.L. c. Ill, § 51 or
			 § 71, and if any Construction or renovation is involved, the Notice of
			 Determination of Need shall not remain in force longer than 12 months unless,
			 within said 12 months, the Holder has filed such final architectural plans and
			 specifications; provided that the Commissioner may approve a written schedule
			 for the phased submission of such plans beyond that period for any project
			 involving Construction having an authorized Capital Expenditure in excess of an
			 amount equal to the Expenditure Minimum with respect to Substantial Capital
			 Expenditures with respect to Hospitals. In the event a written schedule for
			 phased submission of such plans is approved, each portion of the project to
			 which a submission relates shall be consistent with the overall project as
			 approved by the Department and shall not exceed the proportional share of the
			 total approved project cost.
(b)
			 Failure to submit final and complete architectural plans and specifications
			 plans by the date specified by the Department, or by an approved schedule for
			 plan submission pursuant to
			 105 CMR
			 100.310(A)(6), may result
			 in:
1. the initiation of revocation procedures
			 pursuant to
			 105
			 CMR 100.640; or
2. the disallowance of inflation calculated
			 pursuant to
			 105 CMR 100.310(A)(9)
			  for the amount of time equal to the time
			 period between the due date for submission of final plans as prescribed by the
			 Department, and the date of actual submission by the Holder. The disallowance
			 of inflation for this time period shall be calculated as if the time period
			 occurred immediately preceding the commencement of Construction.
(c) No Construction may begin
			 pursuant to a Notice of Determination of Need until the Holder has met all
			 applicable Department and other Government Agency licensure requirements,
			 including plan review. Part 1 Plan Review by the Department may coincide, as is
			 reasonably feasible, with Department consideration of a Proposed Project
			 pursuant to 105 CMR 100.000.
(d)
			 The Holder shall ensure Construction of any new building or the complete
			 rehabilitation of a building implemented pursuant to a Notice of Determination
			 of Need shall meet all Prerequisites and meet or exceed certifiable "silver
			 level", or equivalent, of the Leadership in Energy and Environmental
			 Design-Health Care (LEED-HC) Green Guide for Healthcare (GGHC), or an
			 equivalent nationally recognized best practice standard, as approved by the
			 Department
(7) The
			 written schedule for the phased submission of architectural plans and
			 specifications submitted by the Holder pursuant to
			 105 CMR 100.310(6)
			  shall be used to measure continuing progress
			 toward completion of the project for which a Notice of Determination of Need
			 has been issued.
(8) The Government
			 Agency license of the Health Care Facility or Health Care Facilities, for which
			 and on behalf of, the Holder possesses a valid Notice of Determination of Need,
			 shall be conditioned with all Standard and Other Conditions attached to the
			 Notice of Determination of Need.
(9) Unless extended for Good Cause Related to
			 Project Implementation, the Department shall receive from the Holder firm,
			 itemized figures specifying the final project costs, or current phase thereof,
			 which shall not be greater than those approved by the Department pursuant to
			 the issued Notice for Determination of Need plus any increase in cost due to
			 the allowable rate of inflation. This submission shall occur within six months
			 following the receipt of written final approval of architectural plans and
			 specifications by the Department or other applicable Government Agency; or, in
			 the case of projects for which a schedule of phased plan submission has been
			 approved, each phase submitted. The Holder shall submit the final project costs
			 in a format specified by the Commissioner. No additional increases in the
			 maximum Capital Expenditure, inflationary or otherwise, shall be approved
			 beyond 12 months after the initial licensure of beds and opening of the
			 facility or service. The final approved project costs shall be submitted by the
			 Commissioner to all Parties of Record. Should the Holder fail to submit final
			 project costs pursuant to
			 105 CMR
			 100.310(A)(9), the Holder
			 shall be subject to enforcement actions as set forth within the Notice of
			 Determination of Need's Standard and Other Conditions.
(10) Unless explicitly exempt within 105 CMR
			 100.000, the terms and Conditions shall require that the Holder develop a Plan
			 which shall document the Holder's obligations pursuant to
			 105 CMR
			 100.210(A)(6). Said plan
			 shall require the Holder to expend, over a five-year period, or any other
			 period as specified by the Commissioner, an amount which in total shall be
			 greater than or equal to 5% of the total Capital Expenditure of the approved
			 project, except in cases where exemptions within 105 CMR 100.000 may apply.
			 Said projects shall address one or more of the Health Priorities set out in
			 Department Guidelines.
(11) If the
			 Health Care Facility or Heath Care Facilities for which the Notice of
			 Determination of Need has been issued is eligible, the Holder shall provide
			 written attestation on behalf of the Health Care Facility or Heath Care
			 Facilities, under the pains and penalties of perjury, of participation, or
			 their intent to participate, in MassHealth pursuant to 130 CMR 400.000 through
			 499.000.
(12) The Holder shall
			 report to the Department, at a minimum on an annual basis, and in a form,
			 manner, and frequency as specified by the Commissioner. At a minimum, said
			 reporting shall include, but not be limited to, the reporting of measures
			 related to the project's achievement of the Determination of Need Factors, as
			 directed by the Department pursuant to
			 105 CMR
			 100.210.
(13) If it is determined by the Department
			 that the Holder has failed to sufficiently demonstrate compliance with one or
			 more Conditions, the Holder shall fund projects which address one or more of
			 the Health Priorities set out in Department Guideline, as approved by the
			 Department, which in total, shall equal up to 2.5% of the total Capital
			 Expenditure of the approved project. Said projects shall address one or more of
			 the Health Priorities set out in Department Guideline, and shall be in addition
			 to those projects approved by the Department in fulfillment of
			 105 CMR
			 100.210(A)(6). In making
			 such determination, the Department shall provide written notification to the
			 Holder at least 30 days prior to requiring such funding, and shall provide the
			 Holder the opportunity to appear before the Department. The Department shall
			 consider circumstances external to the Holder that may impact the Holder's
			 ability to demonstrate compliance.
(14) The Holder shall provide to Department
			 Staff a plan for approval by the Office of Health Equity for the development
			 and improvement of language access and assistive services provided to the
			 Holder's Patient Panel, including individuals with disabilities and patients
			 who do not speak English, or have Limited English Proficiency (LEP), or use
			 American Sign Language (ASL).
(15)
			 The Holder shall provide for interpreter services to the Holder's Patient
			 Panel. The Holder shall ensure that all medical and non-medical interpreters,
			 inclusive of staff, contractors, and volunteers providing interpreter services
			 to the Holder's Patient Panel maintain current multilingual proficiency and
			 have sufficient relevant training. Training for non-medical interpreters should
			 include, at a minimum:
(a) the skills and
			 ethics of interpretation; and
(b)
			 cultural health beliefs systems and concepts relevant to non-clinical
			 encounters.
(c) Training for
			 medical interpreters should include, at a minimum:
1. the skills and ethics of interpretation;
			 and
2. multilingual knowledge of
			 specialized terms, including medical terminology, competency in specialized
			 settings, continuing education, and concepts relevant to clinical and
			 non-clinical encounters.
(16) The Holder shall require and arrange for
			 ongoing education and training for administrative, clinical, and support staff
			 in culturally and linguistically appropriate services (CLAS) including, but not
			 limited to, patient cultural and health belief systems and effective
			 utilization of available interpreter services.
(17) All Standard and Other Conditions
			 attached to the Notice of Determination of Need shall remain in effect for a
			 period of five years following completion of the project for which the Notice
			 of Determination of Need was issued, unless otherwise expressly specified
			 within one or more Condition.
(18)
			 In the event that the Holder is required by the Health Policy Commission to
			 develop and file a Performance Improvement Plan (PIP) pursuant to 958 CMR
			 10.00:
Performance Improvement Plans,
then the Holder shall
			 report to the Department that the Holder has filed the PIP and is engaged in
			 ongoing efforts to implement the PIP consistent with 958 CMR 10.00. The Holder
			 will timely provide all information necessary for CHIA to perform its analysis
			 required by M.G.L. c. 12C, § 18 and for the HPC to determine if the Holder
			 must develop and file a PIP. If the HPC finds the Holder has not fully complied
			 with the requirements of the PIP implementation process, as set forth in 958
			 CMR 10.00, then, notwithstanding the HPC finding, the Holder shall report to
			 the Department on why the Department should find that the Holder is still in
			 compliance with the terms and conditions of the Notice of Determination of
			 Need.