THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY SCAVELLO, BAKER, BOYD, CALTAGIRONE, DeLUCA, GEORGE, HARHART, HELM, HENNESSEY, HORNAMAN, KILLION, KIRKLAND, KORTZ, KOTIK, MILLARD, MILLER, MILNE, MOUL, O'NEILL, PASHINSKI, PEIFER, PICKETT, READSHAW, REICHLEY, VULAKOVICH, WAGNER, WATSON, YOUNGBLOOD, KNOWLES, JOSEPHS AND GIBBONS, JANUARY 19, 2011

REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE, JANUARY 19, 2011  

AN ACT

Amending the act of December 20, 1985 (P.L.457, No.112),

entitled "An act relating to the right to practice medicine

and surgery and the right to practice medically related acts;

reestablishing the State Board of Medical Education and

Licensure as the State Board of Medicine and providing for

its composition, powers and duties; providing for the

issuance of licenses and certificates and the suspension and

revocation of licenses and certificates; providing penalties;

and making repeals," adding definitions; and providing for

licensure of prosthetists, orthotists, pedorthists and

orthotic fitters.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Section 2 of the act of December 20, 1985

(P.L.457, No.112), known as the Medical Practice Act of 1985, is

amended by adding definitions to read:

Section 2.  Definitions.

The following words and phrases when used in this act shall

have the meanings given to them in this section unless the

context clearly indicates otherwise:

* * *

"Accommodative."  Designed with a primary goal of conforming

to an individual's anatomy.

* * *

"Custom-fabricated device."  A prosthesis, orthosis or

pedorthic device that is fabricated to original measurements or

a mold for use by a patient in accordance with a prescription or

work order and which requires substantial clinical and technical

judgment in its design and fitting.

"Custom-fitted device."  A prefabricated prosthesis, orthosis

or pedorthic device that is sized or modified for use by the

patient in accordance with a prescription or work order and

which requires substantial clinical judgment and substantive

alteration for appropriate use.

* * *

"ICE."  The Institute for Credentialing Excellence,

previously known as the National Organization for Competency

Assurance (NOCA).

* * *

"NCCA."  The National Commission for Certifying Agencies or

its successor.

"Nontherapeutic devices."  Devices that do not address a

medical condition.

"Orthotic fitter."  An individual who is licensed under this

act to practice orthotics pursuant to a written prescription of

a physician, podiatrist, certified registered nurse practitioner

or physician assistant or pursuant to a work order.

"Orthotics."  Evaluating, measuring, designing, fabricating,

assembling, fitting, adjusting or servicing an orthosis for the

correction or alleviation of neuromuscular or musculoskeletal

dysfunction, disease, injury or deformity, as provided in this

act.

"Orthotist."  An individual other than an orthotic fitter

licensed under this act to practice orthotics pursuant to a

written prescription of a physician, podiatrist, certified

registered nurse practitioner or physician assistant or pursuant

to a work order.

"Over-the-counter prostheses, orthoses and pedorthic

devices."  Prefabricated, mass-produced items that are

prepackaged and require no professional advice or judgment in

either size selection or use, including fabric or elastic

supports, corsets, generic arch supports and elastic hose.

"Pedorthic device."  Includes therapeutic shoes, shoe

modifications made for therapeutic purposes, partial foot

prostheses, foot orthoses and below-the-knee pedorthic

modalities. The term does not include nontherapeutic,

accommodative inlays and nontherapeutic accommodative footwear,

regardless of method of manufacture; unmodified, nontherapeutic

over-the-counter shoes; or prefabricated unmodified or

unmodifiable foot care and footwear products.

"Pedorthics."  Evaluating, measuring, designing, fabricating,

assembling, fitting, adjusting or servicing necessary to

accomplish the application of a pedorthic device for the

prevention or amelioration of painful or disabling conditions

related to the lower extremities.

"Pedorthist."  An individual licensed under this act to

practice pedorthics pursuant to a written prescription of a

physician, podiatrist, certified registered nurse practitioner

or physician assistant or pursuant to a work order.

* * *

"Podiatrist."  An individual licensed under the act of March

2, 1956 (1955 P.L.1206, No.375), known as the Podiatry Practice

Act, to practice podiatry.

"Prefabricated orthosis."  A brace or support designed to

provide for alignment, correction or prevention of neuromuscular

or musculoskeletal dysfunction, disease, injury or deformity.

The term does not include fabric or elastic support, corsets,

arch supports, low-temperature plastic splints, trusses, elastic

hose, canes, crutches, soft cervical collars, dental appliances

or other similar devices carried in stock and sold as over-the-

counter items by a drug store, department store, corset shop or

surgical supply facility.

"Prosthesis."  A custom-designed, custom-fabricated, custom-

fitted or custom-modified device to replace an absent external

limb for purposes of restoring physiological function or

cosmesis. The term does not include artificial eyes, ears,

fingers or toes, dental appliances, cosmetic devices, such as

artificial breasts, eyelashes or wigs, or other devices that do

not have a significant impact on the musculoskeletal functions

of the body.

"Prosthetics."  Evaluating, measuring, designing,

fabricating, assembling, fitting, adjusting or servicing a

prosthesis.

"Prosthetist."  An individual licensed under this act to

practice prosthetics pursuant to a written prescription of a

physician, podiatrist, certified registered nurse practitioner

or physician assistant or pursuant to a work order.

* * *

"Therapeutic devices."  Devices that address a medical

condition.

* * *

Section 2.  The act is amended by adding a section to read:

Section 13.4.  Prosthetists, orthotists, pedorthists and

orthotic fitters.

(a)  Licensure qualifications.--To qualify for licensure to

practice prosthetics, orthotics, pedorthics or orthotic fitting,

an applicant shall:

(1)  Be of good moral character.

(2)  Possess the following education:

(i)  For prosthetists, at least four years of

education, training and/or work experience, consisting of

a bachelor's degree with a major in prosthetics or

orthotics and prosthetics, an associate degree in

prosthetics or orthotics and prosthetics or two or more

years of education, training and/or work experience in

the field of prosthetics; and a minimum of two years

(3,800 hours) of experience in providing direct patient

care services. Patient logs must be kept and available

for audit purposes.

(ii)  For orthotists, at least four years of

education, training and/or work experience, consisting of

a bachelor's degree with a major in orthotics or

orthotics and prosthetics, an associate degree in

orthotics or orthotics and prosthetics or two or more

years of education, training and/or work experience in

the field of orthotics; and a minimum of two years (3,800

hours) of experience in providing direct patient care

services. Patient logs must be kept and available for

audit purposes.

(iii)  For pedorthists, a successfully completed

board-approved entry-level pedorthic education program

and a minimum of 1,000 hours of supervised patient

fitting experience.

(iv)  For orthotic fitters, a successfully completed

board-approved entry-level education program specific to

orthotic fitting and a minimum of 1,000 hours of

documented patient care.

(3)  Have fulfilled all educational and training required

for certification by a prosthetic, orthotic, pedorthic and

orthotic fitting credentialing organization recognized by

ICE, accredited by NCCA and approved by the board.

(4)  Pass all examinations that are required for

certification by a prosthetic, orthotic, pedorthic or

orthotic fitting credentialing organization recognized by

ICE, accredited by NCCA and approved by the board.

(5)  Submit a board-approved application and any fees as

prescribed by the board by regulation.

(6)  Not be addicted to alcohol, narcotics or other

habit-forming drugs.

(7)  Not been convicted of a felony under the act of

April 14, 1972 (P.L.233, No.64), known as The Controlled

Substance, Drug, Device and Cosmetic Act, or of an offense

under the laws of another jurisdiction which, if committed in

this Commonwealth, would be a felony under The Controlled

Substance, Drug, Device and Cosmetic Act, unless the

following apply:

(i)  Ten years have elapsed from the date of

conviction.

(ii)  The applicant satisfactorily demonstrates to

the board that the applicant has made significant

progress in personal rehabilitation since the conviction

and the licensure of the applicant is not expected to

create a substantial risk of harm to the health and

safety of the applicant's clients or the public or a

substantial risk of further criminal violations.

(iii)  The applicant otherwise satisfies the

qualifications required under this act.

(b)  Term of license.--A license issued pursuant to this

section shall be valid for two years and may be renewed

biennially with the board as provided in subsection (g). 

(c)   Prosthetic, orthotic, pedorthic and orthotic fitting

treatment requirements.--Prior to administering the first

prosthetic, orthotic, pedorthic or orthotic fitting treatment, a

prosthetist, orthotist, pedorthist or orthotics fitter shall do

all of the following:

(1)  Ensure the patient has secured a prescription or

work order along with clinical notes for treatment using

prosthetics, orthotics, pedorthics or orthotic fitting from a

physician, podiatrist, certified registered nurse

practitioner or physician assistant. A prescription or work

order under this paragraph shall place conditions and

restrictions on the course of treatment if required as a

matter of sound medical practice.

(2)  Ensure the patient has undergone a medical

diagnostic examination or has had the results of a recently

performed medical diagnostic examination reviewed by a

physician, podiatrist, certified registered nurse

practitioner or physician assistant.

(3)  Keep a copy of the prescription or work order and

the results of the medical diagnostic examination in the

patient's file.

(d)  Exceptions.--

(1)  Nothing in this section shall prohibit students

enrolled in a prosthetics, orthotics, pedorthics or orthotics

fitter educational program from performing prosthetics,

orthotics, pedorthics or orthotic fitting in the course of

their instruction, provided that a physician or podiatrist is

readily available for consultations and that a prosthetist,

orthotist, pedorthist or orthotic fitter, respectively, is on

site and responsible for the direct supervision of students.

(2)  Nothing in this section shall prohibit an individual

from engaging in the practice for which that individual is

licensed or certified to practice or to act within the scope

of that license or certification held in this Commonwealth.

Nothing in this act shall prohibit an individual who is

employed by the Federal Government from engaging in the

practice of a prosthetist, orthotist, pedorthist or orthotic

fitter while in the discharge of the employee's official

duties.

(3)  Nothing in this section shall prohibit the sale of

over-the-counter prostheses, orthoses or pedorthic devices.

(4)  Nothing in this section shall prohibit a

representative of a medical device manufacturer registered

with the United States Food and Drug Administration from

measuring, fitting and adjusting orthoses when the

representative is supervised by a physician or other licensed

health care professional.

(e)  License requirement effective.--Commencing two years

after the effective date of this section, individuals shall not

practice or hold themselves out as being able to practice

prosthetics, orthotics, pedorthics or orthotic fitting in this

Commonwealth unless the individuals are licensed in accordance

with this section.

(f)  License without examination.--Within two years after the

effective date of this section, an individual may be granted a

prosthetic, orthotic, pedorthotic or orthotic fitting license by

the board if the individual:

(1)  Complies with subsection (a)(1), (2), (5), (6) and

(7); and

(2)  Complies with the following:

(i)  holds a valid national certification as a

prosthetist, orthotist, pedorthist or orthotic fitter;

and

(ii)  has been in active, continuous practice for the

three years immediately preceding the effective date of

this section.

(g)  Biennial license renewal.--For biennial renewal of a

license:

(1)  A prosthetist and orthotist must provide

certification of successful completion of a minimum of 24

hours of continuing education as approved by the board.

(2)  An orthotic fitter and a pedorthist must provide

certification of successful completion of a minimum of 13

hours of continuing education as approved by the board.

(3)  Certification of continuing education credit hours

submitted by the prosthetist, orthotist, pedorthist or

orthotic fitter shall be verified as being correct and true

by the applicant.

(4)  A licensee must file a completed board-approved

renewal application.

(5)  A licensee must pay any fees established by

regulation by the board.

(6)  No credit for continuing education may be given for

courses in office management or practice building.

(7)  The board may waive all or part of the continuing

education requirements to a licensee who shows to the

satisfaction of the board that the licensee was unable to

complete the requirement due to illness, emergency or

hardship.

(h)  Orthotic fitter scope of practice.--The scope of

practice of an orthotic fitter is limited to measuring, fitting,

dispensing and adjusting prefabricated devices not requiring

more than minor modification of:

(1)  Cervical soft foam collars.

(2)  Thoraco-lumbo-sacral orthoses.

(3)  Lumbo-sacral orthoses.

(4)  Knee orthoses.

(5)  Ankle foot orthoses.

(6)  Foot orthoses.

(7)  Elbow orthoses.

(8)  Shoulder orthoses.

(9)  Abdominal and pelvic:

(i)  Trusses.

(ii)  Flexible supports.

(iii)  Maternity supports.

(10)  Compression devices:

(i)  Lymphedema garments.

(ii)  Compression garments.

(iii)  Burn garments.

(11)  Breast prosthesis and ancillary supplies.

(i)  Liability insurance coverage.--An individual licensed to

practice prosthetics, orthotics, pedorthics or orthotic fitting

in this Commonwealth shall maintain a level of professional

liability insurance coverage in the minimum amount of $1,000,000

per occurrence or claims made and shall verify to the board the

required coverage. Failure to maintain insurance coverage as

required shall subject the licensee to disciplinary proceedings.

The licensee must provide proof of coverage to the board upon

request. The board shall accept from a licensee as satisfactory

evidence of insurance coverage any of the following:

(1)  Personally purchased liability insurance.

(2)  Professional liability insurance coverage provided

by the individual licensee's employer or similar insurance

coverage acceptable to the board.

(j)  Practice by unregistered persons.–-Any person who is not

licensed as a prosthetist, orthotist, pedorthist or orthotic

fitter shall not practice prosthetics, orthotics, pedorthics or

orthotic fitting nor in any written or printed circular or in

any business card, letterhead or sign or otherwise assume the

title "Prosthetist," "Orthotist," "Pedorthist" or "Orthotic

Fitter" nor any other title, abbreviation, name or description

implying or calculated to lead to the belief that he is

qualified to practice prosthetics, orthotics, pedorthics or

orthotic fitting.

Section 3.  The board shall promulgate regulations to

implement the amendment or addition of sections 2 and 13.4 of

the act within 18 months of the effective date of this section.

The amendment or addition of sections 2 and 13.4 of the act

shall not be enforceable by the State Board of Medicine until

the publication of final regulations under this section or 24

months following the effective date of this section, whichever

occurs first.

Section 4.  This act shall take effect immediately.