Determination of Need Factors

(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. 111, § 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. 111, § 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). 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.