10- 144 C.M.R. ch. 503, § 10-1

Current through 2024-51, December 18, 2024

Section 144-503-10-1 - Determinations Required

Except as provided in section 336, the Commissioner shall issue a Certificate of Need if the Commissioner determines and makes specific written findings regarding that determination that:

A. That the applicant is fit, willing and able to provide the proposed services at the proper standard of care as demonstrated by, among other factors, whether the quality of any health care provided in the past by the applicant or a related party under the applicant's control meets industry standards;

B. The economic feasibility of the proposed services is demonstrated in terms of:

1 Capacity of the applicant to support the project financially over its useful life, in light of the rates the applicant expects to be able to charge for the services to be provided by the project; and

2 Applicant's ability to establish and operate the project in accordance with existing and reasonably anticipated future changes in federal, State and local licensure and other applicable or potentially applicable rules;

C. There is a public need for the proposed services as demonstrated by certain factors, including, but not limited to:

1 Whether, and the extent to which, the project will substantially address specific health problems, as measured by health needs in the area to be served by the project;

2 Whether the project will have a positive impact on the health status indicators of the population to be served;

3 Whether the services affected by the project will be accessible to all residents of the area proposed to be served; and

4 Whether the project will provide demonstrable improvements in quality and outcome measures applicable to the services proposed in the project;

D. That the proposed services are consistent with the orderly and economic development of health facilities and health resources for the State as demonstrated by:

1 The impact of the project on total health care expenditures after taking into account, to the extent practical, both costs and benefits of the project and the competing demands in the local service area and statewide for available resources for health care;

2 The availability of State funds to cover any increase in State costs associated with utilization of the project's services; and

3 The likelihood that more effective and accessible, or less costly, alternative technologies or methods of service delivery may become available.

In making a determination under this subsection, the Commissioner shall use data available in the State health plan under section 253, data from the Maine Health Data Organization established in chapter 1683 and other information available to the Commissioner. Particular weight must be given to information that indicates that the proposed health services are innovations in high quality health care delivery, that the proposed health services are not reasonably available in the proposed area and that the facility proposing the new health services is designed to provide excellent quality health care.

E. Is Consistent with the State Health Plan. For this determination, the Commissioner will be guided by the priority criteria set forth in the State Health Plan. Those projects meeting the greatest number of criteria in any of the relevant priority groupings will be given the highest priority and consideration for approval by the Commissioner. The criteria below are listed in rank priority order.

1. Projects that protect public health and safety Projects with the primary objective of eliminating threats to patient safety. Projects that incorporate comprehensive disease detection, treatment and rehabilitation, that show evidence of leading to decreases in inappropriate utilization, and other evidence based strategies to reduce the impact of such chronic illness as cardiovascular disease, cancer, asthma, chronic lung disease, diabetes and mental illness, furthering the goal of moving our health care system toward the chronic care model. Projects that reflect a redirection of resources and focus on population-based health and prevention. Such projects will allow us to move toward our goal of shifting resources toward areas of greatest need which is for prevention and care of the chronically ill. Projects that demonstrate best practices in building construction, renovation and operation to minimize environmental impact both internally and externally (e.g. "green" energy).

2. Projects that contribute to lower costs of care and greater efficiencies: Projects that will reduce future demand for health care services Projects that result in reduced operating costs for existing facilities. Projects that physically consolidate hospitals or services that serve all or part of the same area that demonstrate an appropriate, cost effective use for the "abandoned" infrastructure, that do not result in increased costs to the health care system and that, in accordance with State policy as expressed in Maine's Growth Management Act, do not contribute to sprawl. Telemedicine projects that facilitate improvements and cost-efficiencies in the quality of diagnosis and treatment in smaller, rural communities.

3. Projects that advance access to services and reflect a collaborative, evidence-based strategy for introducing new services and technologies: Projects that make the best use of existing capacity/infrastructure in initiatives focused on expanding access to ambulatory or primary care services. Projects introducing new technology or services will only be considered if evidence is provided showing detailed analysis of peer reviewed research and data supporting the technology and need and clearly detailing the impact of the project on health care spending in Maine over the short, medium and long term time horizons. Projects must be recommended by the Maine Quality Forum and documented evidence of collaboration exists to assure shared use of new resources across the State, rather than proliferation and/or duplication of new technology.

In addition, high priority will be assigned to applicants able to demonstrate the following:

RESERVED Applicants demonstrating investment in and/or use of an electronic medical records system with an HL7 interface, allowing for exchange of information. This priority assignment will be available to any applicant, regardless of the project applied for. The policy rationale underlying this priority assignment is our desire to encourage implementation of the infrastructure necessary to facilitate integrated clinical information systems. Such systems will serve to improve the quality of care and , ultimately, reduce the cost of care.

Projects that involve any of the following characteristics cannot be considered priority projects:

Projects that duplicate existing services or facilities in a region or community that has existing capacity for such services. This limitation assists in the orderly development of the health care system and in our efforts to control costs. Projects that result in an increase in the number of inpatient beds in the State. Putting additional beds on-line, without a complementary reduction in beds elsewhere will infuse additional costs into the system. Projects that involve the construction of a new hospital (other than replacement facilities). Projects that involve major expansions of existing services and/or facilities.

F. Ensures high-quality outcomes and does not negatively affect the quality of care delivered by existing service providers;

G. Does not result in inappropriate increases in service utilization, according to the principles of evidence-based medicine adopted by the Maine Quality Forum, as established in Title 24-A, section 6951.

10- 144 C.M.R. ch. 503, § 10-1