(A) The Department
shall determine that need exists for a Proposed Project, on the basis of
material in the record, where the Applicant makes a clear and convincing
demonstration that the Proposed Project meets each Determination of Need Factor
set forth within
105 CMR
100.210, unless otherwise expressly specified
within 105 CMR 100.000.
(1)
Applicant Patient Panel Need, Public Health Value, and Operational
Objectives.
(a) The Applicant has
demonstrated sufficient need for the Proposed Project by the Applicant's
Patient Panel;
(b) The Applicant
has demonstrated that the Proposed Project will add measurable public health
value in terms of improved health outcomes and quality of life of the
Applicant's Patient Panel, while providing reasonable assurances of health
equity;
(c) The Department has
determined that the Applicant has provided sufficient evidence that the
Proposed Project will operate efficiently and effectively by furthering and
improving continuity and coordination of care for the Applicant's Patient
Panel, including, sufficient evidence that the Proposed Project will create or
ensure appropriate linkages to patients' primary care services;
(d) The Applicant has provided evidence of
consultation, both prior to and after the Filing Date, with all Government
Agencies with relevant licensure, certification, or other regulatory oversight
of the Applicant or the Proposed Project;
(e) The Applicant has provided evidence of
sound community engagement and consultation throughout the development of the
Proposed Project, including documentation of the Applicant's efforts to ensure
engagement of community coalitions statistically representative of the
Applicant's Patient Panel. Representation should consider age, gender and
sexual identity, race, ethnicity, disability status, as well as socioeconomic
and health status; and
(f) The
Applicant has demonstrated that the Proposed Project will compete on the basis
of price, total medical expenses, provider costs, and other recognized measures
of health care spending.
(2)
Health
Priorities.
(a) The Applicant has
sufficiently demonstrated that the Proposed Project will meaningfully
contribute to the Commonwealth's goals for cost containment, improved public
health outcomes, and delivery system transformation; and
(b) The Department has determined, either:
1. The Applicant's Proposed Project, in its
entirety, meets one or more of the Health Priorities set out in Department
Guideline, and therefore, is exempt from
105 CMR
100.210(A)(6); or
2. The Applicant has provided sufficient
evidence that the Applicant's proposed fulfillment of
105 CMR
100.210(A)(6) will
sufficiently advance one or more of the Health Priorities set out in Department
Guideline.
(3)
Compliance. The Department has determined, in
consultation with all Government Agencies with relevant licensure,
certification, or other regulatory oversight of the Applicant or the Proposed
Project, that the Applicant has provided sufficient evidence of compliance and
good standing with federal, state, and local laws and regulations including,
but not limited to, compliance with all previously issued Notices of
Determination of Need and the terms and Conditions attached therein.
(4)
Financial
Feasibility.
(a) The Department,
in consultation with CHIA, has determined that the Applicant has provided
sufficient documentation of the availability of sufficient funds for capital
and ongoing operating costs necessary to support the Proposed Project without
negative impacts or consequences to the Applicant's Patient Panel. Said
documentation shall include an analysis by an independent certified public
accountant (CPA). Said independent CPA's analysis shall include, but not be
limited to: a review of the Applicant's and where appropriate, as a matter of
standard accounting practices, its Affiliates, past and present operating and
capital budgets; balance sheets; projected cash flow statements; proposed
levels of financing for the Proposed Project, including a compilation of
prospective financial information, such as a forecast or a projection, for the
subsequent five-year period prepared in accordance with the attestation
standards established by the American Institute of Certified Public
Accountants, and any other relevant information required for the independent
CPA to provide reasonable assurances to the Department that the Proposed
Project is financially feasible and within the financial capability of the
Applicant, and where appropriate, as a matter of standard accounting practice,
its Affiliates; and
(b) If the
Commissioner has determined that an independent cost-analysis is required
pursuant to M.G.L. c. Ill, § 25C(h), the analysis has demonstrated that
the Proposed Project is consistent with the Commonwealth's efforts to meet the
health care cost-containment goals.
(5)
Relative Merit.
The Applicant has provided sufficient evidence that the Proposed Project, on
balance, is superior to alternative and substitute methods for meeting the
Patient Panel needs identified by the Applicant pursuant to
105 CMR
100.210(A)(1). Evaluation of
105 CMR
100.210(A)(5) shall take
into account, at a minimum, the quality, efficiency, and capital and operating
costs of the Proposed Project relative to potential alternatives or
substitutes, including alternative evidence-based strategies and public health
interventions.
(6)
Community-based Health Initiatives. For all Proposed
Projects, consistent with M.G.L. c. Ill, § 25C, and unless otherwise
specified within 105 CMR 100.000, the Department has approved the Applicant's
proposed plans for fulfilling its responsibilities set out in the Department's
Community-based Health Initiatives Guideline. Said plans shall form the basis
for funding projects which address one or more of the Health Priorities; shall
be documented and enforceable as a Condition of any Notice of Determination of
Need issued pursuant to 105 CMR 100.000; and for all Proposed Projects, unless
otherwise specified within 105 CMR 100.000, such funding shall in total be
greater than or equal to 5% of the total Capital Expenditure of the Proposed
Project.
(a) For a Proposed Project on behalf
of a Long-term Care Facility, which is not deemed a Conservation Project by the
Department, funding shall be 3% of the total Capital Expenditure of the
Proposed Project.
(b) For a
Proposed Project on behalf of a Health Care Facility, other than a Long-term
Care Facility deemed a Conservation Project by the Department, funding shall be
2.5% of the total Capital Expenditure of the proposed Conservation
Project.
(c) For a Proposed Project
on behalf of a Long-term Care Facility, which is deemed a Conservation Project
by the Department, funding shall be 1% of the total Capital Expenditure of the
proposed Conservation Project.
(B)
(1) A
Determination of Need Application for a Transfer of Ownership pursuant to
105 CMR
100.735 is exempt from the following
Determination of Need Factors, unless otherwise specified in
105 CMR
100.210(A)(5), and
(6).
(2) A Proposed Project deemed a Conservation
Project by the Department is exempt from Factors in
105 CMR
100.210(A)(1), (2), and
(5).
(3) Unless otherwise specified by the
Department, an Emergency Application for Determination of Need pursuant to
105 CMR
100.740 shall be exempt from all
Determination of Need Factors specified in
105 CMR
100.210
(C) Nothing in
105 CMR
100.210 shall be construed to prohibit the
Department from issuing a Notice of Determination of Need for a project, or
part thereof, where, in the case of an Applicant's failure to meet each
applicable Factor, the Department determines that the defect can be
sufficiently remedied by the setting of an appropriate Condition of approval
pursuant to
105 CMR
100.360.