2022 -- H 6610

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LC003586

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2022

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A N   A C T

RELATING TO HEALTH AND SAFETY

     Introduced By: Representatives Baginski, Casimiro, and Bennett

     Date Introduced: January 06, 2022

     Referred To: House Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

amended by adding thereto the following chapter:

CHAPTER 97

MEDICAL SPAS

     23-97-1. Definitions.

     For purposes of this chapter:

     (1) "Ablative lasers or ablative energy devices" means lasers intended to excise or vaporize

the outer layer of skin.

     (2) "Advanced Practice Registered Nurse" or "APRN" means a registered nurse who has

an active, unrestricted advanced practice registered nurse license granted under the authority of

chapter 34 of title 5.

     (3) "Cosmetic medical procedure" means any procedure that does not require sedation that

is performed on a person and is directed at improving the person's appearance and does not

meaningfully promote the proper function of the body or prevent or treat illness or disease.

Cosmetic medical procedures may include, but are not limited to, cosmetic surgery, microneedling,

hair transplants, cosmetic injections, cosmetic soft tissue fillers, dermaplaning, dermastamping,

dermarolling, dermabrasion that removes cells beyond the stratum corneum, chemical peels using

modification solutions that exceed thirty percent (30%) concentration with a pH value of lower

than 3.0, laser hair removal, laser skin resurfacing, laser treatment of leg veins, sclerotherapy and

other laser procedures, intense pulsed light, injection of cosmetic filling agents and neurotoxins and

the use of class II medical devices designed to induce deep skin tissue alteration. The performance

of cosmetic medical services is the practice of medicine and surgery. A cosmetic medical service

shall be performed only by a qualified licensed or certified non-physician if the services have been

delegated by a medical director, supervising physician, or APRN who is responsible for on-site

supervision of the services performed.

     (4) "Delegate" means a non-physician tasked with performing a procedure as defined § 23-

97-1(3) by a physician or APRN.

     (5) "Department" means the Rhode Island department of health.

     (6) "Medical director" means a physician who assumes the role of, or holds oneself out as,

medical director at a medical spa. The medical director shall be:

     (i) Trained in the indications for, and performance of, cosmetic medical procedures,

including all medical devices or instruments that can alter or cause biological change or damage

the skin and subcutaneous tissue. Training programs provided by a manufacturer or vendor of a

medical device or supplies may not be a medical director's, supervising physician's or APRN's only

education in the cosmetic medical service or the operation of medical devices to be used;

     (ii) Responsible for implementing policies and procedures to ensure quality patient care;

     (iii) Responsible for the delegation and supervision of cosmetic procedures;

     (iv) Responsible for the oversight of all cosmetic medical procedures performed by

physicians, APRNs, and non-physicians; and

     (v) Responsible for ensuring that all supervising physicians and supervising APRNs, any

physicians and APRNs performing cosmetic medical procedures, and any non-physicians and non-

APRNs delegated to perform cosmetic medical procedures, are properly trained in the safe and

effective performance of all cosmetic medical procedures that they perform at the medical spa.

     (7) "Medical spa" means an establishment in which cosmetic medical procedures are

performed.

     (8) "Physician" means an allopath or osteopath who has an active license, unrestricted

medical license granted under the authority of chapter 37 of title 5.

     (9) "Supervision" means an arrangement when a qualified supervising physician or APRN

is either:

     (i) On site and able to directly observe the treatment being performed, though not

necessarily in the same room (i.e., direct supervision); or

     (ii) Is off site, but immediately available if needed, either in person or by

telecommunication (i.e., indirect supervision).

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     23-97-2. Protection of patients in a medical spa.

     (a) A physician or APRN who performs cosmetic medical procedures, or supervises such

procedures delegated to and performed by a non-physician or non-APRN, must be trained in the

indications for and performance of the cosmetic medical procedure. An APRN who performs

cosmetic medical procedures, or supervises such procedures delegated to and performed by a non-

physician or non-APRN, must be accredited by the state board of nursing.

     (b) The supervising physician or APRN shall:

     (1) Develop and maintain written office protocols for each cosmetic medical procedure.

Such protocols shall be kept on site at the medical spa for review and/or inspection by the

department.

     (2) Perform an initial assessment of the patient.

     (3) Prepare a written treatment plan for each patient, which plan shall include, as

applicable, diagnoses, course of treatment, and specifications for any device being used.

     (4) Obtain patient consent, if the cosmetic medical procedure(s) are being performed by a

non-physician or non-APRN and documenting, in the patient’s medical record, the credentials and

names of the non-physician or non-APRN who will be performing the cosmetic medical procedure.

     (5) Create and maintain medical records in a manner consistent with applicable laws and

regulations and accepted medical practice.

     (c) Non-physicians and non-APRNs may only perform cosmetic medical procedures:

     (1) For which they have the requisite training; and

     (2) Which have been delegated to them by a supervising physician or APRN.

     (d) At all times in the performance of their duties relative to cosmetic procedures, all

non-physicians and non-APRNs shall:

     (1) Wear identification that identifies them as not being physicians or APRNs. As

applicable, such identification must identify the non-physician/non-APRN’s job title and

credentials, including professional license;

     (2) Review and follow written protocols for each delegated cosmetic medical procedure;

     (3) Verify that the supervising physician or supervising APRN has assessed the patient and

given written treatment instructions for each procedure performed;

     (4) Review the cosmetic medical procedure with each patient;

     (5) Notify the medical director, as well as the supervising physician or supervising APRN,

before the patient leaves or as they become aware, of any adverse events or complications, and

follow up with the patient post-procedure, as appropriate;

     (6) Document all relevant details of the performed cosmetic medical procedure in the

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patient’s medical record; and

     (7) As applicable, satisfy any requirements imposed upon them by their licensing boards.

     (e) Cosmetic medical procedures using ablative lasers or ablative energy devices shall only

be performed by physicians.

     23-97-3. Rules and regulations.

     The department shall, by July 1, 2023, promulgate rules and regulations necessary and not

inconsistent with law to implement the purpose and intent of this chapter, which rules and

regulations shall provide for, though not be limited to, the licensing of medical spas as health care

facilities.

     SECTION 2. Section 23-17-2 of the General Laws in Chapter 23-17 entitled "Licensing of

Healthcare Facilities" is hereby amended to read as follows:

     23-17-2. Definitions.

     As used in this chapter:

     (1) "Affiliate" means a legal entity that is in control of, is controlled by, or is in common

control with another legal entity.

     (2) "Alzheimer's dementia special-care unit or program" means a distinct living

environment within a nursing facility that has been physically adapted to accommodate the

particular needs and behaviors of those with dementia. The unit provides increased staffing;

therapeutic activities designed specifically for those with dementia; and trains its staff on an

ongoing basis on the effective management of the physical and behavioral problems of those with

dementia. The residents of the unit/program have had a standard, medical-diagnostic evaluation

and have been determined to have a diagnosis of Alzheimer's dementia or another dementia.

     (3) "Certified nurse-teacher" means those personnel certified by the department of

elementary and secondary education and employed pursuant to the provisions of §§ 16-21-7 and

16-21-8.

     (4)(i) "Change in operator" means a transfer by the governing body or operator of a

healthcare facility to any other person (excluding delegations of authority to the medical or

administrative staff of the facility) of the governing body's authority to:

     (A) Hire or fire the chief executive officer of the healthcare facility;

     (B) Maintain and control the books and records of the healthcare facility;

     (C) Dispose of assets and incur liabilities on behalf of the healthcare facility; or

     (D) Adopt and enforce policies regarding operation of the healthcare facility.

     (ii) This definition is not applicable to circumstances wherein the governing body of a

healthcare facility retains the immediate authority and jurisdiction over the activities enumerated

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in subsections (4)(i)(A) -- (4)(i)(D).

     (5) "Change in owner" means:

     (i) In the case of a healthcare facility that is a partnership, the removal, addition, or

substitution of a partner that results in a new partner acquiring a controlling interest in the

partnership;

     (ii) In the case of a healthcare facility that is an unincorporated, solo proprietorship, the

transfer of the title and property to another person;

     (iii) In the case of a healthcare facility that is a corporation:

     (A) A sale, lease exchange, or other disposition of all, or substantially all, of the property

and assets of the corporation; or

     (B) A merger of the corporation into another corporation; or

     (C) The consolidation or two (2) or more corporations, resulting in the creation of a new

corporation; or

     (D) In the case of a healthcare facility that is a business corporation, any transfer of

corporate stock that results in a new person acquiring a controlling interest in the corporation; or

     (E) In the case of a healthcare facility that is a nonbusiness corporation, any change in

membership that results in a new person acquiring a controlling vote in the corporation.

     (6) "Clinician" means a physician licensed under chapter 37 of title 5; a nurse licensed

under chapter 34 of title 5; a psychologist licensed under chapter 44 of title 5; a social worker

licensed under chapter 39.1 of title 5; a physical therapist licensed under chapter 40 of title 5; and

a speech language pathologist or audiologist licensed under chapter 48 of title 5.

     (7) "Director" means the director of the Rhode Island state department of health.

     (8) "Freestanding emergency-care facility" means an establishment, place, or facility that

may be a public or private organization, structurally distinct and separate from a hospital; staffed,

equipped, and operated to provide prompt, emergency medical care. For the purposes of this

chapter, "emergency medical care" means services provided for a medical condition or behavioral-

health condition that is manifested by symptoms of sufficient severity that, in the absence of

immediate medical attention, could result in harm to the person or others; serious impairment to

bodily functions; serious dysfunction of any bodily organ or part; or development or continuance

of severe pain.

     (9) "Healthcare facility" means any institutional health-service provider, facility, or

institution, place, building, agency, or portion thereof, whether a partnership or corporation,

whether public or private, whether organized for profit or not, used, operated, or engaged in

providing healthcare services, including, but not limited to: hospitals; nursing facilities; home

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nursing-care provider (which shall include skilled nursing services and may also include activities

allowed as a home-care provider or as a nursing service agency); home-care provider (which may

include services such as personal care or homemaker services); rehabilitation centers; kidney

disease treatment centers; health maintenance organizations; freestanding emergency-care facilities

as defined in this section, and facilities providing surgical treatment to patients not requiring

hospitalization (surgi-centers); hospice care, and physician ambulatory-surgery centers and

podiatry ambulatory-surgery centers providing surgical treatment. The term "healthcare facility"

also includes organized ambulatory-care facilities that are not part of a hospital but that are

organized and operated to provide healthcare services to outpatients, such as: central-services

facilities serving more than one healthcare facility or healthcare provider; treatment centers;

diagnostic centers; outpatient clinics; medical spas as defined in chapter 97 of title 23; infirmaries

and health centers; school-based health centers, and neighborhood health centers. The term

"healthcare facility" also includes a mobile health-screening vehicle as defined in this section. The

term "healthcare facility" shall not apply to organized, ambulatory-care facilities owned and

operated by professional service corporations as defined in chapter 5.1 of title 7, as amended (the

"professional service corporation law"), or to a practitioner's (physician, dentist, or other healthcare

provider) office or group of practitioners' offices (whether owned and/or operated by a hospital or

an affiliate of a hospital or an individual practitioner, alone or as a member of a partnership,

professional service corporation, organization, or association); provided, however, notwithstanding

any other provision herein or in the general laws, any hospital or any affiliate of a hospital that

owns and/or operates a practitioner's office shall ensure that such practitioner's office complies with

licensing or accreditation requirements that may be applicable to the practitioner's office. Individual

categories of healthcare facilities shall be defined in rules and regulations promulgated by the

licensing agency with the advice of the health services council. Rules and regulations concerning

hospice care shall be promulgated with regard to the "Standards of a Hospice Program of Care,"

promulgated by the National Hospice Organization. Any provider of hospice care who provides

hospice care without charge shall be exempt from the licensing provisions of this chapter but shall

meet the "Standards of a Hospice Program of Care." Facilities licensed by the department of

behavioral healthcare, developmental disabilities and hospitals and the department of human

services, and clinical laboratories licensed in accordance with chapter 16.2 of this title, as well as

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. shall not be considered healthcare facilities for purposes of this

chapter.

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     (10) "Homemaker," or however else called, means a trained, nonprofessional worker who

performs related housekeeping services in the home for the sick, disabled, dependent, or infirm,

and as further defined by regulation; the director shall establish criteria for training.

     (11) "Hospital" means a person or governmental entity licensed in accordance with this

chapter to establish, maintain, and operate a hospital.

     (12) "Licensing agency" means the Rhode Island state department of health.

     (13) "Medical services" means any professional services and supplies rendered by, or under

the direction of, persons duly licensed under the laws of this state to practice medicine, surgery, or

podiatry that may be specified by any medical service plan. Medical service shall not be construed

to include hospital services.

     (14) "Mobile health-screening vehicle" means a mobile vehicle, van, or trailer that delivers

primary and preventive healthcare screening services, and:

     (i) Does not maintain active contracts or arrangements with any health insurer subject to

regulation under chapter 20 or 42 of title 27;

     (ii) Does not maintain active contracts or arrangements with another licensed healthcare

facility as that term is defined within this section; and

     (iii) Does not provide medical services free of charge.

     (15) "Non-English speaker" means a person who cannot speak or understand, or has

difficulty in speaking or understanding, the English language, because he/she uses only, or

primarily, a spoken language other than English, and/or a person who uses a sign language and

requires the use of a sign-language interpreter to facilitate communication.

     (16) "Person" means any individual, trust or estate, partnership, corporation (including

associations, joint stock companies, and insurance companies), state, or political subdivision or

instrumentality of a state.

     (17) "Physician ambulatory-surgery center" means an office, or portion of an office, that is

utilized for the purpose of furnishing surgical services to the owner and/or operator's own patients

on an ambulatory basis, and shall include both single-practice, physician ambulatory-surgery

centers and multi-practice, physician ambulatory-surgery centers. A "single-practice, physician

ambulatory-surgery center" is a physician ambulatory center owned and/or operated by a physician-

controlled professional service corporation as defined in chapter 5.1 of title 7 (the "professional

service corporation law"), or a physician-controlled limited-liability company (as defined in chapter

16 of title 7 (the "limited liability company act")) in which no physician is an officer, shareholder,

director, or employee of any other corporation engaged in the practice of the same profession, or a

private physician's office (whether owned and/or operated by an individual practitioner, alone or

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as a member of a partnership, professional service corporation, limited-liability company,

organization, or association). A "multi-practice, physician ambulatory-surgery center" is a

physician ambulatory-surgery center owned and/or operated by a physician-controlled professional

service corporation (as defined in the professional service corporation law) or a physician-

controlled limited-liability company (as defined in the limited liability company act) in which a

physician is also an officer, shareholder, director, or employee of another corporation engaged in

the practice of the same profession, or a group of physicians' offices (whether owned and/or

operated by an individual practitioner, alone or as a member of a partnership, professional service

corporation, limited-liability company, organization, or association).

     (18) "Podiatry ambulatory-surgery center" means an office or portion of an office that is

utilized for the purpose of furnishing surgical services to the owner and/or operator's own patients

on an ambulatory basis, and shall include both single-practice, podiatry ambulatory-surgery centers

and multi-practice podiatry ambulatory-surgery centers. A "single-practice podiatry ambulatory-

surgery center" is a podiatry ambulatory center owned and/or operated by a podiatrist-controlled

professional service corporation (as defined in chapter 5.1 of title 7 (the "professional service

corporation law")), or a podiatrist-controlled limited-liability company (as defined in chapter 16 of

title 7 (the "limited liability company act")) in which no podiatrist is an officer, shareholder,

director, or employee of any other corporation engaged in the practice of the same profession, or a

private podiatrist's office (whether owned and/or operated by an individual practitioner, alone or as

a member of a partnership, professional service corporation, limited-liability company,

organization, or association). A "multi-practice, podiatry ambulatory-surgery center" is a podiatry

ambulatory-surgery center owned and/or operated by a podiatrist-controlled professional service

corporation (as defined in the professional service corporation law) or a podiatrist-controlled,

limited-liability company (as defined in the limited liability company act) in which a podiatrist is

also an officer, shareholder, director, or employee of another corporation engaged in the practice

of the same profession, or a group of podiatrists' offices (whether owned and/or operated by an

individual practitioner, alone or as a member of a partnership, professional service corporation,

limited-liability company, organization, or association).

     (19) "Qualified interpreter" means a person who, through experience and/or training, is

able to translate a particular foreign language into English, with the exception of sign-language

interpreters who must be licensed in accordance with chapter 71 of title 5.

     (20) "Qualified sign-language interpreter" means one who has been licensed in accordance

with the provisions of chapter 71 of title 5.

     (21) "School-based health center" means a facility located in an elementary or secondary

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school licensed as a school-based health center that delivers primary and/or preventive healthcare

services to individuals to include, but not be limited to, students on site.

     SECTION 3. Section 23-15-2 of the General Laws in Chapter 23-15 entitled

"Determination of Need for New Healthcare Equipment and New Institutional Health Services" is

hereby amended to read as follows:

     23-15-2. Definitions.

     As used in this chapter:

     (1) "Affected person" means and includes the person whose proposal is being reviewed, or

the applicant, healthcare facilities located within the state that provide institutional health services,

the state medical society, the state osteopathic society, those voluntary nonprofit area-wide

planning agencies that may be established in the state, the state budget office, the office of health

insurance commissioner, any hospital or medical-service corporation organized under the laws of

the state, the statewide health coordinating council, contiguous health-systems agencies, and those

members of the public who are to be served by the proposed, new institutional health services or

new healthcare equipment.

     (2) "Cost-impact analysis" means a written analysis of the effect that a proposal to offer or

develop new institutional health services or new healthcare equipment, if approved, will have on

healthcare costs and shall include any detail that may be prescribed by the state agency in rules and

regulations.

     (3) "Director" means the director of the Rhode Island state department of health.

     (4)(i) "Healthcare facility" means any institutional health-service provider, facility or

institution, place, building, agency, or portion of them, whether a partnership or corporation,

whether public or private, whether organized for profit or not, used, operated, or engaged in

providing healthcare services that are limited to hospitals, nursing facilities, home nursing-care

provider, home-care provider, hospice provider, inpatient rehabilitation centers (including drug

and/or alcohol abuse treatment centers), freestanding emergency-care facilities as defined in § 23-

17-2, 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 § 23-17-2(17), (18), respectively)

are exempt from the requirements of chapter 15 of this title; provided, however, 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 § 5-37-1) within two (2) years following the

formation of such medical practice group, when such medical practice group is formed by the

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merger or consolidation of two (2) or more medical practice groups or the acquisition of one

medical practice group by another medical practice group. Medical spas as defined in chapter 97

of title 23 are exempt from the requirements of chapter 15 of this title. The term "healthcare 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.

     (ii) Any provider of hospice care who provides hospice care without charge shall be exempt

from the provisions of this chapter.

     (5) "Healthcare provider" means a person who is a direct provider of healthcare 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 healthcare services for

persons.

     (6) "Health services" means organized program components for preventive, assessment,

maintenance, diagnostic, treatment, and rehabilitative services provided in a healthcare facility.

     (7) "Health services council" means the advisory body to the Rhode Island state department

of health established in accordance with chapter 17 of this title, appointed and empowered as

provided to serve as the advisory body to the state agency in its review functions under this chapter.

     (8) "Institutional health services" means health services provided in or through healthcare

facilities and includes the entities in or through that the services are provided.

     (9) "New healthcare equipment" means any single piece of medical equipment (and any

components that constitute operational components of the piece of medical equipment) proposed

to be utilized in conjunction with the provision of services to patients or the public, the capital costs

of which would exceed two million two hundred fifty thousand dollars ($2,250,000); provided,

however, that the state agency shall exempt from review any application that proposes one-for-one

equipment replacement as defined in regulation. Further, beginning July 1, 2012, and each July

thereafter, the amount shall be adjusted 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.

     (10) "New institutional health services" means and includes:

     (i) Construction, development, or other establishment of a new healthcare facility.

     (ii) Any expenditure, except acquisitions of an existing healthcare facility, that will not

result in a change in the services or bed capacity of the healthcare facility by, or on behalf of, an

existing healthcare facility in excess of five million two hundred fifty thousand dollars ($5,250,000)

which is a capital expenditure including expenditures for predevelopment activities; provided

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further, beginning July 1, 2012, and each July thereafter, the amount shall be adjusted 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.

     (iii) Where a person makes an acquisition by, or on behalf of, a healthcare facility or health

maintenance organization under lease or comparable arrangement or through donation, which

would have required review if the acquisition had been by purchase, the acquisition shall be deemed

a capital expenditure subject to review.

     (iv) Any capital expenditure that results in the addition of a health service or that changes

the bed capacity of a healthcare facility with respect to which the expenditure is made, except that

the state agency may exempt from review, by rules and regulations promulgated for this chapter,

any bed reclassifications made to licensed nursing facilities and annual increases in licensed bed

capacities of nursing facilities that do not exceed the greater of ten (10) beds or ten percent (10%)

of facility licensed bed capacity and for which the related capital expenditure does not exceed two

million dollars ($2,000,000).

     (v) Any health service proposed to be offered to patients or the public by a healthcare

facility that was not offered on a regular basis in or through the facility within the twelve-month

(12) period prior to the time the service would be offered, and that increases operating expenses by

more than one million five hundred thousand dollars ($1,500,000), except that the state agency may

exempt from review, by rules and regulations promulgated for this chapter, any health service

involving reclassification of bed capacity made to licensed nursing facilities. Further, beginning

July 1, 2012, and each July thereafter, the amount shall be adjusted 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.

     (vi) Any new or expanded tertiary or specialty-care service, regardless of capital expense

or operating expense, as defined by and listed in regulation, the list not to exceed a total of twelve

(12) categories of services at any one time and shall include full-body magnetic resonance imaging

and computerized axial tomography; provided, however, that the state agency shall exempt from

review any application that proposes one-for-one equipment replacement as defined by and listed

in regulation. Acquisition of full body magnetic resonance imaging and computerized axial

tomography 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 January 1, 2010, and was in operation on or before July 1, 2010.

     (11) "Person" means any individual, trust or estate, partnership, corporation (including

associations, joint stock companies, and insurance companies), state or political subdivision, or

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instrumentality of a state.

     (12) "Predevelopment activities" means expenditures for architectural designs, plans,

working drawings, and specifications, site acquisition, professional consultations, preliminary

plans, studies, and surveys made in preparation for the offering of a new, institutional health

service.

     (13) "State agency" means the Rhode Island state department of health.

     (14) "To develop" means to undertake those activities that, on their completion, will result

in the offering of a new, institutional health service or new healthcare equipment or the incurring

of a financial obligation, in relation to the offering of that service.

     (15) "To offer" means to hold oneself out as capable of providing, or as having the means

for the provision of, specified health services or healthcare equipment.

     SECTION 4. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY

***

     This act would require medical spas to employ or contract for the services of a licensed

physician, physician assistant, or registered nurse. Additionally, each spa would be required to post

information about personnel performing cosmetic medical procedures, and provide a written notice

to a person before said procedure is performed.

     This act would take effect upon passage.

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