2006 -- H 7103 SUBSTITUTE B

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LC01616/SUB B

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2006

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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

     Referred To: House Corporations

It is enacted by the General Assembly as follows:

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

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Facilities" is hereby repealed in its entirety.

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     CHAPTER 5-59

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Prosthetist and Prosthetic Facilities

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

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

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health.

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

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

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

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

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

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

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

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

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

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

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

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as certified prosthetists.

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

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

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

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

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

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general revenues.

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

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

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

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possession of that title shall be presented to the division.

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

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

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

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this chapter.

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

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

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

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

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

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

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($31.25) shall be required.

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

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

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and regulations may be revised annually.

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

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

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

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

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

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

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

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

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

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amended by adding thereto the following chapter:

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     CHAPTER 59.1

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RHODE ISLAND ORTHOTICS AND PROSTHETICS PRACTICES

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

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

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

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Orthotics and Prosthetics Practices Act."

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

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

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successor agency.

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

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

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

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

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rectification of an image.

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

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

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

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

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

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

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prosthetics.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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and function of the orthotic device by periodic evaluation.

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

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

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

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

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

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as commercially available stock items for no specific patient.

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

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

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

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

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

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artificial breasts.

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

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

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

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

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

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

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

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

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

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

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

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

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

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the prosthetic device by periodic evaluation.

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

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

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

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

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

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

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

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

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

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

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

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

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

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based on that particular person's condition.

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

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

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practice as certified licensed orthotists or prosthetists.

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

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

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

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

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

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general revenues.

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

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

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

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

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presented to the department.

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

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provide proof of:

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

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

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requirements of the National Commission on Orthotic and Prosthetic Education;

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

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

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

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corresponds.

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

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

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

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

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

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

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licensed;

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

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

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

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

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Education;

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

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

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

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

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

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

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

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

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section 5-59.1-12

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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shall be required.

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

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

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

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

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

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by law, the department has the authority to:

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

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

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qualifications;

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

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

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

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on any matter relating to the enforcement of this chapter.

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

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

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

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

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

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

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

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

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

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

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     SECTION 2. This act shall take effect January 1, 2007.

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LC01616/SUB B

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N A C T

RELATING TO ORTHOTICS AND PROSTHETICS

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     This act would provide for the licensure of orthotists and prosthetists, and would provide

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penalties for unauthorized practices in order to regulate the practices and protect the public.

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     This act would take effect January 1, 2007.

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LC01616/SUB B

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