216 R.I. Code R. 216-RICR-40-10-22.2 - Definitions

A. Wherever used in this Part the following terms shall be defined as follows:

1. "Accelerated review" means a shortened certificate of need review of a proposal which the state agency has identified and preliminarily determined to present a prima facie demonstration of public need and affordability.

2. "Act" means R.I. Gen Laws Chapter 23-15 entitled "Health Care Certificate of Need Act of Rhode Island".

3. "Administrative review agency" means the agency designated by the Director in accordance with R.I. Gen. Laws § 23-15-6(b)(10) of the Act to conduct administrative reviews when requested by persons directly affected by decisions of the state agency in accordance with § 22.18 of this Part.

4. "Affected persons" means and includes, but is not limited to, the person whose proposal is being reviewed, or the applicant; health care facilities located within the state which provide institutional health services; the state medical society; the state osteopathic society; the medical school; such voluntary non-profit area-wide planning agencies as may be established in the state; statutory planning bodies; the state budget office, the Office of the Health Insurance Commissioner, and hospital or medical service corporation organized under the laws of the state; and those members of the public who are to be served by the proposed new institutional health services or new health care equipment.

5. "Affordability" means the relative ability of the people of the state to pay for or incur the cost of a proposal, given:

a. Consideration of the condition of the state's economy;

b. Consideration of the statements of authorities and/or parties affected by such proposals;

c. Economic, financial, and/or budgetary constraints of parties affected by such proposals, including cost impact statements submitted by the State Medicaid Agency or State Budget Officer;

d. Other factors deemed relevant by the Health Services Council or the Director.

6. "Clinical health services" means one or more organized program components for preventive, assessment, maintenance, diagnostic, treatment and rehabilitative services, provided in a health care facility.

7. "Construction" means the erection, building, renovation, replacement or alteration of the physical plant of a health care facility.

8. "Cost impact analysis" means a written analysis of the effect that a proposal to offer or develop new institutional health services or new health care equipment, if approved, will have on health care costs and shall include, but not be limited to, consideration of the proposal's effects on increases in operating expenses, per diem rates, health care insurance premiums, Medicaid reimbursement, and public health expenditures.

9. "Director" means the Director of the Rhode Island Department of Health.

10. "Domestic medical tourism" means the practice of patients traveling to states other than their residence for the provision of healthcare services pursuant to R.I. Gen. Laws Chapter 23-93.

11. "Equity" means non-debt funds contributed towards the capital cost of an acquisition or project which are free and clear of any repayment obligation or liens against assets, and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged.

12. "Health care facility" means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether organized for profit or not, used, operated, or engaged in providing health care services, which are limited to hospitals, nursing facilities, home care provider, home nursing care provider, hospice provider, inpatient rehabilitation centers, certain facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers, multi-practice physician ambulatory surgery centers and multi-practice podiatry ambulatory surgery centers) and facilities providing inpatient hospice care. Single-practice physician or podiatry ambulatory surgery centers (as defined in R.I. Gen. Laws §§ 23-17-2(13) and 23-17-2(14) respectively) are exempt from the requirements of the Act; provided that such exemption shall not apply if a single-practice physician or podiatry ambulatory surgery center is established by a medical practice group (as defined in R.I. Gen. Laws § 5-37-1) within two (2) years following the formation of such medical practice group, when such medical practice group is formed by the merger or consolidation of two (2) or more medical practice groups or the acquisition of one medical practice group by another medical practice group. The term "health care facility" does not include Christian Science institutions (also known as Christian Science Nursing Facilities) listed and certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc.

13. "Health care provider" means a person who is a direct provider of health care services (including but not limited to physicians, dentists, nurses, podiatrists, physician assistants or nurse practitioners) in that the person's primary current activity is the provision of health care services for persons.

14. "Health Services Council" means the advisory body to the Rhode Island Department of Health established in accordance with R.I. Gen. Laws Chapter 23-17, appointed and empowered to serve as the advisory body to the state agency in its review functions under the Act.

15. "Hospital" shall have the same meaning as defined in the rules and regulations for Licensing of Hospitals (Part 4 of this Subchapter).

16. "Inpatient hospice care" shall have the same meaning as defined in the rules and regulations for Licensing Hospice Care (Part 11 of this Subchapter).

17. "Inpatient rehabilitation center" shall have the same meaning as defined in the rules and regulations for Rehabilitation Hospital Centers (Part 16 of this Subchapter), established pursuant to R.I. Gen. Laws Chapter 23-17.

18. "Institutional health services" means health services provided in or through health care facilities and includes the entities in or through which such services are provided.

19. "New health care equipment" means any single piece of medical equipment (and any components which constitute operational components thereof) proposed to be utilized in conjunction with the provision of services to patients or the public, the capital costs of which (including acquisition under lease or comparable arrangement or through donation) would exceed two million five hundred forty two thousand and two hundred thirty four dollars ($2,542,234). The amount shall be adjusted each July by the percentage of increase in the consumer price index for all urban consumers (CPI-U) as published by the United States Department of Labor Statistics as of September 30 of the prior calendar year.

20. "New institutional health services" means and includes:

a. Construction, development, or other establishment of a new health care facility.

b. Any expenditure (except acquisitions of an existing health care facility which will not result in a change in the services or bed capacity of such health care facility) by or on behalf of an existing health care facility in excess of five million nine hundred thirty two thousand and ninety dollars ($5,932,090) which is a capital expenditure, including expenditures for predevelopment activities. The amount shall be adjusted each July by the percentage of increase in the consumer price index for all urban consumers (CPI-U) as published by the United States Department of Labor Statistics as of September 30 of the prior calendar year.

(1) The term capital expenditure includes all expenditure of funds (whether by purchase or lease) not properly chargeable as expenses of operation and maintenance, which is associated with the provision of a health service or related to a unified plan of renovation or construction or development, including equipment proposed to be offered or undertaken during the course of any twelve (12) month period where the total of such expenditures exceeds five million nine hundred thirty two thousand and ninety dollars ($5,932,090).

(2) The term capital expenditure includes the cost of studies, surveys, designs, plans, working drawings, and specifications, as well as expenditures directly or indirectly related to capital expenditures such as grading, paving, broker commission, taxes assessed during the construction period, costs involved in demolishing or razing structures on land, title fees, permit and license fees, architect, legal, accounting and appraisal fees, capitalized interest, and other costs incurred for borrowing funds. In short, the total estimated cost of all elements or components of a functional facility including land, plant, building or equipment (whether purchased or leased) for providing services to health care facility patients, personnel, or the visiting public are included in the term capital expenditure.

c. Capital expenditures further include obligations of capital expenditures by any person to acquire an existing health care facility if the notice of intent required in accordance with § 22.6 of this Part is not filed or if the state agency finds, within thirty (30) days after the date it received notice in accordance with § 22.6 of this Part, that the service or bed capacity of the facility will be changed in any of the following ways in being acquired:

(1) Change in bed capacity which increases the total number of beds, or

(2) Change in bed capacity which redistributes beds among discrete services (e.g., obstetrics, pediatrics, medical, surgical) or levels of care (e.g., intensive coronary, special, post-acute, skilled nursing, intermediate, rehabilitative) or relocates beds from one physical facility or site to another by ten (10) beds or ten percent (10%), whichever is less, in any two-year period, or

(3) The addition of a health service not provided in or through the facility throughout the previous twelve (12) months, or

(4) The termination of a health service provided in or through the facility.

d. Where a person makes an acquisition by or on behalf of a health care facility, or health maintenance organization or other person under lease or comparable arrangement or through donation, which would have required review if the acquisition had been by purchase, such acquisition shall be deemed a capital expenditure subject to review. An acquisition for less than fair market value must be reviewed if the acquisition at fair market value would be subject to review under § 22.2(A)(20)(b) of this Part.

e. Where a person makes an expenditure for predevelopment activities, as defined in this Part, which exceeds five million nine hundred thirty two thousand and ninety dollars ($5,932,090) for the pertinent time period, such expenditure shall be deemed a capital expenditure subject to review. Approval of expenditures only for predevelopment activities will not authorize the offering or development of or preclude subsequent review of the new institutional health service with respect to which such predevelopment activities are proposed. Expenditures for predevelopment activities which do not exceed five million nine hundred thirty two thousand and ninety dollars ($5,932,090) and approved expenditures for predevelopment activities which do exceed five million nine hundred thirty two thousand and ninety dollars ($5,932,090) where the associated new institutional health service is subsequently denied, will not be subject to the sanctions outlined in R.I. Gen. Laws § 23-15-4(h) of the Act.

f. Except for licensed nursing facilities, any capital expenditure which increases the total number of beds in a health care facility with respect to which the expenditure is made.

g. Licensed nursing facilities shall be exempt from review for increases in licensed bed capacity that do not exceed ten (10) beds or ten percent (10%) of facility licensed bed capacity, whichever is greater, during any twelve (12) month period, provided that the capital expenditure associated with any such increases do not exceed two million dollars ($2,000,000). Any bed increase sought under this exemption must demonstrate to the state agency full and satisfactory compliance with the requirements for the rules and regulations for Licensing of Nursing Facilities (Part 1 of this Subchapter). The twelve (12) month time frame for each nursing facility under this exemption shall commence on the date specified in the state agency's approval of any increase in bed capacity.

h. Any health service, proposed to be offered to patients or the public by a health care facility, which was not offered on a regular basis by or on behalf of said facility throughout the twelve (12) month period prior to the time such service would be offered and which exceeds one million six hundred ninety four thousand eight hundred and eighty three dollars ($1,694,883) in annualized operating costs (including but not necessarily limited to salaries, wages, supplies, depreciation, and interest) as defined in this Part. The amount shall be adjusted each July by the percentage of increase in the consumer price index for all urban consumers (CPI-U) as published by the United States Department of Labor Statistics as of September 30 of the prior calendar year.

i. Any new or expanded tertiary or specialty care service, regardless of capital expense or operating expense, as defined in § 22.2(A)(33) of this Part.

21. "Non-clinical proposal" means any capital expenditure by or on behalf of a health care facility, exempted pursuant to § 22.7 of this Part, that is not directly related to the provision of clinical health services or patient care activities including but not limited to parking lots, information systems, and telephone systems.

22. "Nursing facility" shall have the same meaning as defined in the rules and regulations for Licensing of Nursing Facilities (Part 1 of this Subchapter).

23. "One for one equipment replacement" means the replacement of health care equipment wherein the new health care equipment will not significantly alter the purpose, function, or clinical applications of the health care equipment to be replaced and shall include, but not be limited to, cardiac catheterization, positron emission tomography (PET) or positron emission tomography-computerized tomography (PET-CT), full body magnetic resonance imaging, computerized axial tomography and linear accelerators.

24. "Person" means any individual, trust or estate, partnership, corporation, (including associations, joint stock companies, limited liability corporations and insurance companies) state, or political subdivision or instrumentality of a state or any legal entity.

25. "Predevelopment activities" means expenditures for architectural designs, plans, working drawings and specifications, site acquisition, professional consultations, preliminary plans, studies, and surveys necessary for the preparation of an application for the offering of a new institutional health service.

26. "Premises" means a tract of land and the buildings thereon where direct patient care services are provided.

27. "Public need" means a substantial or obvious community need for the specific new health care equipment or new institutional health service proposed and the scope thereof, in light of the attendant circumstances and in the context of the considerations outlined in §§ 22.5(C) and 22.10(L) of this Part.

28. "Request for Proposals" (RFP) means a public notice duly issued by the state agency which indicates that the state agency has identified, on a preliminary basis, the potential need for development or expansion of a particular institutional health service or new health care equipment and that the state is soliciting proposals addressing such potential need from prospective applicants.

29. "Research proposal" means any formal scientific investigation in basic biomedical or medical research areas undertaken by or on behalf of a health care facility, exempted pursuant to § 22.8 of this Part that is not directly related to the offering of clinical health services or patient care activities.

30. "State agency" means the Rhode Island Department of Health.

31. "State health plan" means such plan or plans as may be developed pursuant to R.I. Gen. Laws § 23-1-1.1, §23-1-1.2 and R.I. Gen. Laws Chapter 23-81 specifying the health goals for the state on the basis of the characteristics, resources and special needs of the state and its population.

32. "Surgi-centers" shall have the same meaning as defined in the rules and regulations for Licensing of Freestanding Ambulatory Surgical Centers (Part 5 of this Subchapter).

33. "Tertiary or specialty care services" means, for reasons of quality, access, efficiency or cost, cardiac catheterization, positron emission tomography, linear accelerators, open heart surgery, organ transplantation, full body magnetic resonance imaging, computerized axial tomography and neonatal intensive care services. For the purpose of this review requirement, an expansion of an existing tertiary or specialty care service involving capital and/or operating expenses for additional equipment or facilities is reviewable; provided, however, that caseload volume increases associated with more efficient utilization for existing equipment and facilities shall not be deemed subject to review as an expanded tertiary or specialty care service. Acquisition of full body magnetic resonance imaging (MRI) and computerized axial tomography (CT) shall not require a certificate of need review and approval by the state agency if satisfactory evidence is provided to the state agency that it was acquired for under one million dollars ($1,000,000) on or before 1 January 2010 and was in operation on or before 1 July 2010.

34. "To develop" means to undertake those activities which, on their completion, will result in the offering of a new institutional health service or new health care equipment or the incurring of a financial obligation, in relation to the offering of such a service or equipment.

35. "To offer" means to hold oneself out as capable of providing, or as having the means for the provision of, specified new institutional health services or new health care equipment.

Notes

216 R.I. Code R. 216-RICR-40-10-22.2