Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 503 - MAINE CERTIFICATE OF NEED PROCEDURES MANUAL FOR HEALTH CARE FACILITIES (OTHER THAN NURSING CARE FACILITIES)
Chapter 3 - DEFINITIONS

Universal Citation: 10 ME Code Rules ยง 3

Current through 2024-38, September 18, 2024

The following words and phrases shall have the following meanings:

1. ACCESS TO CARE means the ability to obtain in a timely manner needed personal health services to achieve the best possible health outcomes balanced by the health system's resource limitations. Access to care may be influenced by many factors, including, without limitation, travel, distance, waiting time, available resources, availability of a source of care and the health status of the population served. 22M.R.S.A. Sec.328(1).

2. AMBULATORY SURGICAL FACILITY means a facility, not part of a hospital, that provides surgical treatment to patients not requiring hospitalization. This term does not include the offices of private physicians or dentists, whether in individual or group practice. 22 M.R.S.A. Sec.328(2).

3. ANNUAL OPERATING COSTS for purposes of section 328, subsection 17-A, paragraph B, means the total incremental costs to the institution that are directly attributable to the addition of a new health service.

4. APPROPRIATELY CAPITALIZED EXPENDITURES means those expenditures that would be capitalized if the project were implemented.

5. BED CAPACITY means the licensed capacity of a health care facility.

6. BED COMPLEMENT means the total number of beds that are normally available for inpatient use. These are beds that are set up and staffed irrespective of any basic standards regarding the number of beds, but excludes beds in corridors and in other non-adaptable areas, labor, holding, emergency, anesthesia and recovery rooms.

7. CAPITAL EXPENDITURE means an expenditure, including a force account expenditure or predevelopment activities, that under generally accepted accounting principles is not properly chargeable as an expense of operation and maintenance and, for the purposes of this chapter, includes capitalized interest on borrowed funds and the fair market value of any property or equipment that is acquired under lease or comparable arrangement or by donation. 22 M.R.S.A. Sec.328(3). "Capital expenditure" includes but is not limited to organizational costs associated with a project such as legal fees related to the capital expenditure and regulatory approvals and costs associated with education, training, etc.

8. RESERVED

9. COMMENCED/COMMENCEMENT. A project shall be considered to have "commenced" when:

A. for the purpose or leasing of equipment, buildings, existing health care facilities, or land; the sale or lease has been consummated and the buyer or lessor is in possession and the property is being used for the purpose described in the application for which the Certificate of Need was issued,

B. for the new construction of a health care facility, part thereof, or associated structure; all predevelopment activity necessary to meet the remaining elements of this provision has been completed, the site has been cleared, the foundation has been fully laid and at least 50% of the approved capital expenditure has been obligated, except for projects with approved capital expenditures in excess of $10 million where at least 50% of the portion of the total capital expenditure which was originally forecast to be completed during the 12 months following the issuance of the Certificate of Need, or any extension thereto, must be obligated,

C. for predevelopment activities, all such activities to be completed are fully obligated and such obligation requires that they be completed within the following six months,

D. for modification of a health care facility not adequately covered by the above-listed requirements; all predevelopment activity necessary to meet the remaining elements of this provision has been completed and at least 50% of the approved capital expenditure has been obligated,

E. for new health services; the service is fully operational,

F. for termination of a health service; the service has been terminated and all approved capital expenditures have been obligated,

G. for changes in bed complement; the change has been completed.

H. for all projects, when the Department or the holder is defending litigation relative to the issuance of a Certificate of Need, provided that the litigation is not initiated by the holder and the holder is making a good faith effort to meet the timetable for making the service or equipment available or for completing the project specified in the approved application.

10. CONSTRUCTION when used in connection with "health care facility" or "major medical equipment" means the establishment, erection, building, purchase or other acquisition of a health care facility. 22 M.R.S.A. Sec.328(4).

11. COST when used in conjunction with the review threshold for "major medical equipment," shall include capital expenditures.

12. DEPARTMENT means the Department of Health and Human Services.

13. DEVELOPMENT when used in connection with "health service," means the undertaking of those activities that on their completion will result in the offering of a new health service to the public. 22 M.R.S.A. Sec.328(5).

14. EXPENDITURE MINIMUM FOR ANNUAL OPERATING COSTS means, for services commenced after October 1, 1998, $400,000 for the 3rd fiscal year, including a partial first year. 22 M.R.S.A. Sec.328(6).

15. RESERVED.

16. GENERALLY ACCEPTED ACCOUNTING PRINCIPLES means accounting principles approved by the American Institute of Certified Public Accountants or a successor organization. 22 M.R.S.A. Sec.328(7).

17. HEALTH CARE FACILITY means a hospital, psychiatric hospital, nursing facility, kidney disease treatment center including a free-standing hemodialysis facility, rehabilitation facility, ambulatory surgical facility, independent radiological service center, independent cardiac catheterization center or cancer treatment center. "Health care facility" does not include the office of a private health care practitioner, as defined in Title 24, section 2502, subsection 1-A,whether in individual or group practice. In an ambulatory surgical facility that functions also as the office of a health care practitioner, the following portions of the ambulatory surgical facility are considered to be a health care facility:

A. Operating rooms;

B. Recovery rooms;

C. Waiting areas for ambulatory surgical facility patients; and

D. Any other space used primarily to support the activities of the ambulatory surgical facility. 22 M.R.S.A. Sec.328(8).

18. HEALTH MAINTENANCE ORGANIZATION means public or private organization that:

A. Provides or otherwise makes available to enrolled participants health care services, including at least the following basic health services: Usual physician services, hospitalization, laboratory, x-ray, emergency and preventive health services and out-of-area coverage;

B. Is compensated, except for copayments, for the provision of the basic health services to enrolled participants on a predetermined periodic rate basis; and

C. Provides physicians' services primarily through physicians who are either employees or partners of the organization or through arrangements with individual physicians or one or more groups of physicians. 22 M.R.S.A. Sec.328(9)(A)-(C).

19. HEALTH NEED means a situation or a condition of a person, expressed in health outcome measures such as mortality, morbidity or disability, that is considered undesirable and is likely to exist in the future. 22 M.R.S.A. Sec.328(10).

20. HEALTH PLANNING means data assembly and analysis, goal determination and the formulation of action recommendations regarding health services. 22 M.R.S.A. Sec.328(11).

21. HEALTH SERVICES means clinically related services that are diagnostic, treatment, rehabilitative services or nursing services provided by a nursing facility, and includes alcohol abuse, drug abuse and mental health services. 22 M.R.S.A. Sec.328(12).

22. HEALTH STATUS means patient or population measures, or both, of good and poor health practices, rates of death and disease, both chronic and infectious, and the prevalence of symptoms or conditions, or both, of illness and wellness. 22 M.R.S.A. Sec.328(13).

23. HOSPITAL means an institution that primarily provides to inpatients, by or under the supervision of physicians, diagnostic services and therapeutic services for medical diagnosis, treatment and care of injured, disabled or sick persons or rehabilitation services for the rehabilitation of injured, disabled or sick persons. This term also includes psychiatric and tuberculosis hospitals. 22 M.R.S.A. Sec.328(14).

24. RESERVED

25. HOSPITAL SWING BED means an acute care bed licensed by the Bureau of Medical Services, Division of Licensing and Certification, for use also as a nursing care bed. Swing beds may be established only in rural hospitals with fewer than 100 licensed acute care beds. 22 M.R.S.A. Sec.328(15).

26. RESERVED

27. MAJOR MEDICAL EQUIPMENT means a single unit of medical equipment or a single system of components with related functions used to provide medical and other health services that costs $1,200,000 or more. "Major medical equipment" does not include medical equipment acquired by or on behalf of a clinical laboratory to provide clinical laboratory services if the clinical laboratory is independent of a physician's office and a hospital and has been determined to meet the requirements of the United States Social Security Act, Title XVIII, Section 1861(s), paragraphs 10 and 11. In determining whether medical equipment costs more than the threshold provided in this subsection, the cost of studies, surveys, designs, plans, working drawings, specifications, construction/renovations and other activities essential to acquiring and making the equipment functional must be included. If the equipment is acquired for less than fair market value, the term "cost" includes the fair market value. Beginning September 30, 2004 and annually thereafter, the threshold amount for review must be updated by the Commissioner to reflect the change in the Consumer Price Index, medical index. 22 M.R.S.A. Sec.328(16).

28. MODIFICATION means the alteration, improvement, expansion, extension, renovation or replacement of a health care facility or health maintenance organization or portions thereof, including the initial equipment and the replacement of equipment or existing buildings. 22 M.R.S.A. Sec.328(17).

29. NEW HEALTH SERVICE means:

A. The obligation of any capital expenditures by or on behalf of a health care facility of $110,000 or more that is associated with the addition of a health service that was not offered on a regular basis by or on behalf of the healthcare facility within the 12-month period prior to the time the services would be offered.

B. The addition of a health service that is to be offered by or on behalf of a healthcare facility that was not offered on a regular basis by or on behalf of a healthcare facility within the 12-month period prior to the time the services would be offered and that, for the 3rd fiscal year of operation, including a partial first year following addition of that service, is projected to entail incremental annual operating costs directly attributable to the addition of that health service of at least $400,000; or

B. The addition in the private office of a health care practitioner, as defined in Title24, section 2502, subsection 1-A, of new technology that costs $1,200,000 or more. The Department shall consult with the Maine Quality Forum Advisory Council established pursuant to Title 24-A, section 6952, prior to determining whether a project qualifies as a new technology in the office of a private practitioner. Beginning September 30, 2004, and annually thereafter, the threshold amount for review must be updated by the Commissioner to reflect the change in the Consumer Price Index medical index. With regard to the private office of a health care practitioner, "new health service" does not include the location of a new practitioner in a geographic area.

"New health service" does not include a health care facility that extends a current service within the defined primary service area of the health care facility by purchasing within a 12-month time period new equipment costing in the aggregate less than the threshold provided in section 328, subsection 16. 22 M.R.S.A. Sec.328(17-A).

30. RESERVED

31. NURSING FACILITY means any facility defined under section 1812-A. 22 M.R.S.A. Sec.328(18).

32. OBLIGATION for a capital expenditure is considered to be incurred by or on behalf of a health care facility:

A. When a contract, enforceable under the law of the State, is entered into by or on behalf of the health care facility for the construction, acquisition, lease or financing of a capital asset;

B. When the governing board of the health care facility takes formal action to commit its own funds for a construction project undertaken by the health care facility as its own contractor; or

C. In the case of donated property, on the date on which the gift is completed under applicable law of the State. 22 M.R.S.A. Sec.328(19)(A)-(C).

33. OFFER when used in connection with "health services," means that the health care facility or health maintenance organization holds itself out as capable of providing or having the means to provide a health service. 22 M.R.S.A. Sec.328(20).

34. OPERATING COSTS means the total non-capital incremental costs attributable to a project approved in accordance with the Maine Certificate of Need Act and rules.

35. PERSON means an individual; trust or estate; partnership; corporation, including associations, joint stock companies and insurance companies; the State or a political subdivision or instrumentality of the State, including a municipal corporation of the State; or any other legal entity recognized by State law. 22 M.R.S.A. Sec.328(21).

36. PERSON DIRECTLY AFFECTED BY A REVIEW includes:

A. The applicant;

B. A group of ten (10) persons residing or located within the health service area served or to be served by the applicant;

C. A health care facility, a health maintenance organization or a health care practitioner that demonstrates that it provides similar services or, by timely filing a Letter of Intent with the Department for inclusion in the record, has indicated an intention to provide similar services in the future to patients residing in the health service area and whose services would be directly and substantially affected by the application under review;

D. A 3rd-party payor, including, without limitation, a health maintenance organization, who pays health care facilities for services in the health service area in which the project is proposed to be located and whose payments would be directly and substantially affected by approval or disapproval of the application under review; and

E. A person who demonstrates a direct and substantial effect upon that person's health care as a result of approval or disapproval of an application under review. 22 M.R.S.A. Sec.328(22)(A)-(E)

F. The Department will provide identified Persons Directly Affected by a Review with copies of final Department analyses and assessments, including copies of final assessments performed by the Maine Center for Disease Control and Prevention and Bureau of Insurance.

37. PREDEVELOPMENT ACTIVITY means any appropriately capitalized expenditure by or on behalf of a health care facility made in preparation for the offering or development of a new health service for which a Certificate of Need would be required and arrangements or commitments made for financing the offering or development of the new health service and includes site acquisitions, surveys, studies, expenditures for architectural designs, plans, working drawings and specifications. 22 M.R.S.A. Sec.328(23).

38. PROJECT means any acquisition, capital expenditure, new health service, or change in a health service, predevelopment activity or other activity that requires a Certificate of Need under section 329. 22 M.R.S.A. Sec.328(24).

39. REGULAR BASIS when used in conjunction with the definition of a new health service, means offered on a routine basis in such a manner as to reasonably accommodate the diagnostic, treatment or rehabilitation needs of patients on a least a weekly basis and provided on at least 50% of the normal business days during which the service is offered within the 12-month period prior to the time the service is intended to be offered.

40. REHABILITATION FACILITY means an inpatient facility that is operated for the primary purpose of assisting in the rehabilitation of disabled persons through an integrated program of medical and other services that are provided under competent professional supervision. 22 M.R.S.A Sec.328(25).

41. REPLACEMENT EQUIPMENT means a piece of capital equipment that replaces another piece of capital equipment that performs essentially the same functions as the replaced equipment. 22 M.R.S.A. Sec.328(26). The equipment being replaced must be removed and/or discontinued from use and must not be used by the applicant or a related entity to provide medical or other health services.

42. SIGNIFICANT CHANGE IN FINANCING when used in relation to activities requiring subsequent review and approval, includes changes in the principal amount, interest rate and term of debt financing, the nature of the pay-back provisions on debt-financing (such as level-debt schedule or level-principal schedule), the amount and nature of equity contributions, the annual amount and duration of depreciation expense charges.

43. RESERVED

44. STATE HEALTH PLAN means the plan developed and issued by the Governor pursuant 2M.R.S.A. c. 5, section 101.

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