Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 10 - Facility regulation › Part 22 - Determination of Need for New Health Care Equipment and New Institutional Health Care Services › Section 216-RICR-40-10-22.2 - Definitions

Current through June 14, 2024
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.