Chapter 129

2006 -- H 7103 SUBSTITUTE B

Enacted 06/16/06

A N A C T

RELATING TO ORTHOTICS AND PROSTHETICS

Introduced By: Representatives Giannini, Moura, Petrarca, T Brien, and Landroche

Date Introduced: February 07, 2006

It is enacted by the General Assembly as follows:

     SECTION 1. Chapter 5-59 of the General Laws entitled "Prosthetists and Prosthetic

Facilities" is hereby repealed in its entirety.

CHAPTER 5-59

Prosthetist and Prosthetic Facilities

5-59-1. Definitions. -- As used in this chapter:

(1) "Division" means the division of professional regulation, Rhode Island department of

health.

(2) "Prosthetist" means a practitioner who provides care to patients with partial or total

absence of a limb by designing, fabricating, and fitting devices, known as prostheses. At the

request of and in consultation with physicians, the prosthetist assists in formulation of

prescriptions for prostheses, and examines and evaluates patients' prosthetic needs in relation to

their disease entity and functional loss. In providing the prostheses, he or she is responsible for

formulating its design, including selection of materials and components; making all necessary

casts, measurements and model modifications; performing fittings including static and dynamic

alignments; evaluating the prosthesis on the patient; instructing the patient in its use, and

maintaining adequate patient records; all in conformity with the prescription.

5-59-2. Certification of practitioners. -- The division shall issue to those persons

eligible under the provisions of this chapter certificates attesting to their qualifications to practice

as certified prosthetists.

5-59-3. Applications for certification. -- Any person who desires to be certified as

stated in section 5-59-2 shall submit, in writing, on the forms that may be provided by the

division, an application for certification which shall be accompanied by a fee of one hundred

twenty-five dollars ($125) together with the other credentials that the division requires. All the

proceeds of any fees collected pursuant to the provisions of this chapter shall be deposited as

general revenues.

5-59-4. Qualifications for certification. -- Qualification for certification under this

chapter shall be the possession of the title "certified prosthetist", as issued by and under the rules

of the American Board for Certification in Orthotics and Prosthetics, Inc. Evidence of the

possession of that title shall be presented to the division.

5-59-5. Use of "certified prosthetist" title. -- No person offering service to the public

shall use the title "certified prosthetist" or shall use the abbreviation "C.P.", or in any other way

represent themselves as certified practitioners unless they hold a current certificate as provided in

this chapter.

5-59-6. Recertification -- Renewal. -- Every holder of a certificate issued under this

chapter shall annually present evidence to the division of continued eligibility as attested to by a

current certificate issued by the American Board of Certification in Orthotics and Prosthetics. All

certificates issued under this chapter shall expire annually on the last day of September unless

sooner renewed. Applications for renewal-recertification shall be made during the month of

September of each year. An annual renewal fee of thirty-one dollars and twenty-five cents

($31.25) shall be required.

5-59-7. Rules and regulations. -- Every prosthetist shall conform to the rules and

regulations of the American Board for Certification in Orthotics and Prosthetics, Inc. These rules

and regulations may be revised annually.

5-59-8. Penalty for violations. -- Any person, firm, corporation, or association violating

any of the provisions of this chapter is deemed to have committed a misdemeanor and upon

conviction shall be punished by a fine not to exceed two hundred dollars ($200) or imprisonment

for a period not to exceed three (3) months, or both the fine and imprisonment.

5-59-9. Severability. -- If any provision of this chapter or of any rule or regulation made

under this chapter, or the application of this chapter to any person or circumstances, is held

invalid by a court of competent jurisdiction, the remainder of the chapter, rule or regulation, and

the application of that provision to other persons or circumstances shall not be affected.

     SECTION 2. Title 5 of the General Laws entitled "Businesses and Professions" is hereby

amended by adding thereto the following chapter:

CHAPTER 59.1

RHODE ISLAND ORTHOTICS AND PROSTHETICS PRACTICES

5-59.1-1. Legislative Intent. -- The purpose of this chapter is to safeguard the public

health to regulate the practice of orthotics and prosthetics by untrained and unethical persons.

5-59.1-2. Short title. -- This act shall be known and may be cited as "The Rhode Island

Orthotics and Prosthetics Practices Act."

5-59.1-3. Definitions. -- As used in this chapter:

(1) "ABC" means the American Board for Certification in Orthotics and Prosthetics or its

successor agency.

(2) "BOC" means the Board for Orthotist/Prosthetist Certification or its successor agency.

(3) "Custom fabricated orthotics" or "custom made orthotics" means devices designed

and fabricated, in turn, from raw materials for a specific patient and require the generation of an

image, form, or mold that replicates the patient's body or body segment and, in turn, involves the

rectification of an image.

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

(5) "Director" means the director of the department of health.

(6) "Direct-formed orthoses" means devices formed or shaped during the molding

process directly on the patient's body or body segment.

(7) "Licensed Orthotist" means a person licensed under this act to practice orthotics.

(8) "Licensed Prosthetist" means a person licensed under this chapter to practice

prosthetics.

(9) "Orthosis" means a custom fabricated brace or support that is designed based on

medical necessity. Orthosis does not include prefabricated or direct-formed orthotic devices, as

defined in this section, or any of the following assistive technology devices: commercially

available knee orthoses used following injury or surgery; spastic muscle-tone inhibiting orthoses;

upper extremity adaptive equipment; finger splints; hand splints; wrist gauntlets; face masks used

following burns; wheelchair seating that is an integral part of the wheelchair and not worn by the

patient independent of the wheelchair; fabric or elastic supports; corsets; low-temperature formed

plastic splints; trusses; elastic hose; canes; crutches; cervical collars; dental appliances; and other

similar devises as determined by the director, such as those commonly carried in stock by a

pharmacy, department store, corset shop, or surgical supply facility.

(10) "Orthotics" means the science and practice of evaluating, measuring, designing,

fabricating, assembling, fitting, adjusting or, servicing, as well as providing the initial training

necessary to accomplish the fitting of, an orthosis for the support, correction, or alleviation of

neuromuscular or musculoskeletal dysfunction, disease, injury or deformity. The practice of

orthotics encompasses evaluation, treatment, and consultation; with basic observational gait and

postural analysis, orthotists assess and design orthoses to maximize function and provide not only

the support but the alignment necessary to either prevent or correct deformity or to improve the

safety and efficiency of mobility or locomotion, or both. Orthotic practice includes providing

continuing patient care in order to assess its effect on the patient's tissues and to assure proper fit

and function of the orthotic device by periodic evaluation.

(11) "Orthotist" means an allied health professional who is specifically trained and

educated to provide or manage the provision of a custom-designed, fabricated, modified and

fitted external orthosis to an orthotic patient, based on a clinical assessment and a physician's

prescription, to restore physiological function and/or cosmesis, and certified by ABC or BOC.

(12) "Prefabricated orthoses" or "off-shelf orthoses" means devices that are manufactured

as commercially available stock items for no specific patient.

(13) "Prosthesis" means an artificial limb that is alignable or, in lower extremity

applications, capable of weight bearing. Prosthesis also means an artificial medical device that is

not surgically implanted and that is used to replace a missing limb, appendage, or other external

human body part including an artificial limb, hand, or foot. The term does not include artificial

eyes, ears, noses, dental appliances, osotmy products, or devices such as eyelashes or wigs or

artificial breasts.

(14) "Prosthetics" means the science and practice of evaluation, measuring, designing,

fabricating, assembling, fitting, aligning, adjusting or servicing, as well as providing the initial

training necessary to accomplish the fitting of, a prosthesis through the replacement of external

parts of a human body, lost due to amputation or congenital deformities or absences. The practice

of prosthetics also includes the generation of an image, form, or mold that replicates the patient's

body or body segment and that requires rectification of dimensions, contours and volumes for use

in the design and fabrication of a socket to accept a residual anatomic limb to, in turn, create an

artificial appendage that is designed either to support body weight or to improve or restore

function or cosmesis, or both. Involved in the practice of prosthetics is observational gait analysis

and clinical assessment of the requirements necessary to refine and mechanically fix the relative

position of various parts of the prosthesis to maximize function, stability, and safety of the

patient. The practice of prosthetics includes providing and continuing patient care in order to

assess the prosthetic device's effect on the patient's tissues and to assure proper fit and function of

the prosthetic device by periodic evaluation.

(15) "Prosthetist" means a practitioner, certified by the ABC or BOC, who provides care

to patients with partial or total absence of a limb by designing, fabricating, and fitting devices,

known as prostheses. At the request of and in consultation with physicians, the prosthetist assists

in formulation of prescriptions for prostheses, and examines and evaluates patients' prosthetic

needs in relation to their disease entity and functional loss. In providing the prostheses, he or she

is responsible for formulating its design, including selection of materials and components;

making all necessary costs, measurements and model modifications; performing fittings including

static and dynamic alignments; evaluating the prosthesis on the patient; instructing the patient in

its use, and maintaining adequate patient records; all in conformity with the prescription.

(16) "Physician" means a doctor of allopathic medicine (M.D.), osteopathic medicine

(D.O.), podiatric medicine (D.P.M.), and chiropractic medicine (D.C.).

(17) "Off-the-shelf orthosis" means devices manufactured by companies registered with

the Federal Food and Drug Administration other than devices designed for a particular person

based on that particular person's condition.

5-59.1-4. Licensing of practitioners. -- The department shall issue to those persons

eligible under the provisions of this chapter certificate licenses attesting to their qualifications to

practice as certified licensed orthotists or prosthetists.

5-59.1-5. Application for orthotic or prosthetic license. -- Any person who desires to

be licensed as set forth in section 5-59.1-4 shall in writing submit an application on forms

provided by the department for a license accompanied by a fee of two hundred fifty dollars

($250) with all other credentials that the department requires and as required by this chapter. All

the proceeds of any fees collected pursuant to the provisions of this chapter shall be deposited as

general revenues.

5-59.1-6. Qualifications for license -- (a) Qualification for licensing under this chapter

shall be the possession of the title "certified prosthetist" or "certified orthotist", as issued by and

under the rules of the American Board for Certification in Orthotics and Prosthetics, Inc. or the

Board for Orthotist/Prosthetist certification. Evidence of the possession of that title shall be

presented to the department.

(b) In order to qualify for a license to practice orthotics or prosthetics a person shall

provide proof of:

(1) Possession of a baccalaureate degree from an accredited college or university;

(2) Completion of an orthotic, or prosthetic education program that meets or exceeds the

requirements of the National Commission on Orthotic and Prosthetic Education;

(3) Completion of a clinical residency in orthotics and/or prosthetics that meets or

exceeds the standards of the National Commission on Orthotic and Prosthetic Education; and

(4) Current certification by ABC or BOC in the discipline for which the application

corresponds.

5-59.1-7. Use of "licensed prosthetist" or "licensed orthotist" title. -- No person

offering service to the public shall use the title licensed prosthetist or licensed orthotist or shall

use the abbreviation "L.P." or "L.O", or in any other way represent themselves as licensed

practitioners unless they hold a current license as provided in this chapter.

5-59.1-8. Exceptions. -- This chapter shall not be construed to prohibit:

(a) A physician licensed in this state from engaging in the practice for which he or she is

licensed;

(b) The practice of orthotics or prosthetics by a person who is employed by the federal

government while in the discharge of the employee's official duties;

(c) The practice of orthotics or prosthetics by a resident continuing his or her clinical

education in a residency accredited by the National Commission on Orthotic and Prosthetic

Education;

(d) Consistent with his or her license, a licensed pharmacist, physical or occupational

therapist, or certified athletic trainer from engaging in his or her profession; or

(e) Measuring, fitting, or adjusting an off-the-shelf orthosis by employees or authorized

representatives of an orthosis manufacturer, which is registered with the Federal Food and Drug

Administration when such employee or representative is supervised by a physician.

5-59.1-9. License and biannual renewal required. -- No person may practice orthotics

or prosthetics without a license issued under authority of this chapter, which license has not been

suspended or revoked as provided under this chapter, without renewal biannually, as provided in

section 5-59.1-12.

5-59.1-10. Grandfather clause. -- Any person currently practicing full-time in the state

of Rhode Island on the effective date of this act in an orthotist and/or prosthetic facility as a

certified BOC or ABC orthotist and/or prosthetist must file an application for licensure prior to

sixty (60) days after the effective date of this act, to continue practice at his or her identified level

of practice. The applicant must provide verifiable proof of active certification in orthotics and/or

prosthetics by the ABC or BOC. This section shall not be construed to grant licensing to a person

who is a certified or registered orthotic or prosthetic "fitter" or orthotic or prosthetic "assistant."

5-59.1-11. Limitation on provisions of care and services. -- A licensed orthotist and/or

prosthetist may provide care and services only if care and services are provided pursuant to an

order from a licensed physician, unless the item which may be purchased without a prescription.

5-59.1-12. Relicensing -- Renewal. -- Every holder of a license issued under this chapter

shall biannually attest to the department as to current certification issued by the American Board

of Certification in Orthotics and Prosthetics or the Board for Orthotists/Prosthetist Certification.

All licenses issued under this chapter shall expire biannually on the last day of September of

every odd numbered year. A biannual renewal fee of one hundred twenty-five dollars ($125)

shall be required.

Every orthotist and prosthetist shall conform to the standards of the American Board for

Certification in Orthotics and Prosthetics or Board for Orthotists/Prosthetists Certification.

5-59.1-13. Rules and regulations. – The department is authorized to promulgate such

regulations as it deems necessary to implement the provisions of this act.

5-59.1-14. Responsibilities of the department. -- In addition to other authority provided

by law, the department has the authority to:

(1) Register applicants, issue licenses to applicants who have met the education, training

and requirements for licensure, and deny licenses to applicants who do not meet the minimum

qualifications;

(2) Maintain the official department records of all applicants and licensees;

(3) Establish requirements and procedures for an inactive license; and

(4) Seek the advice and knowledge of the prosthetic and orthotic associations in this state

on any matter relating to the enforcement of this chapter.

5-59.1-15. Penalty for violations. -- Any person, firm, corporation or association

violating any of the provisions of this chapter is deemed to have committed a misdemeanor and

upon conviction shall be punished by a fine not to exceed two hundred dollars ($200), or

imprisonment for a period not to exceed three (3) months, or both, and for a second or subsequent

violation by a fine of not less than three hundred dollars ($300) nor more than five hundred

dollars ($500), or imprisonment for one year, or both the fine and imprisonment.

5-59.1-16. Severability. -- If any provision of this chapter or of any rule or regulation

made under this chapter, or the application of this chapter to any person or circumstances, is held

invalid by a court of competent jurisdiction, the remainder of the chapter, rule or regulation, and

the application of that provision to other persons or circumstances shall not be affected.

     SECTION 3. This act shall take effect January 1, 2007.

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LC01616/SUB B

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