THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY SCAVELLO, SIPTROTH, PEIFER, BAKER, BEYER, DONATUCCI, GEORGE, HELM, HENNESSEY, KILLION, KIRKLAND, KORTZ, KOTIK, MILLER, MILNE, MOUL, O'NEILL, PASHINSKI, PICKETT, READSHAW, REICHLEY, VULAKOVICH, WATSON, YOUNGBLOOD AND ROHRER, FEBRUARY 5, 2009

AS REPORTED FROM COMMITTEE ON PROFESSIONAL LICENSURE, HOUSE OF REPRESENTATIVES, AS AMENDED, JUNE 9, 2009   

AN ACT

Amending the act of March 2, 1956 (1955 P.L.1206, No.375),

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entitled, as reenacted and amended, "An act relating to and

defining the practice of podiatry; conferring powers and

imposing duties on the State Board of Podiatry Examiners and

the Department of State; requiring licensure; providing for

the granting, cancellation, suspension and revocation of

licenses; preserving the rights of existing licenses;

providing for the promulgation of rules and regulations;

transfer of jurisdiction and records to the board; regulation

of schools of chiropody and podiatry; reciprocity; and

providing penalties, and remedies," further providing for

definitions, for exclusive jurisdiction of the board, for

reporting of multiple licensure and for practice by

unregistered persons; providing for prosthetists, orthotists,

orthotic fitters and pedorthists; further providing for

penalties, for refusal to grant, suspension and revocation,

for reinstatement of license, certificate or registration,

for display of license and certificate and for injunction or

other process; and providing for expungement.

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

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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 March 2, 1956 (1955 P.L.

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1206, No. 375), known as the Podiatry Practice Act, reenacted

and amended August 24, 1963 (P.L.1199, No.505) and amended Dec.

20, 1985 (P.L.384, No.107), is amended by adding subsections to

read:

Section 2.  Definitions.--The following words or phrases,

unless the context clearly indicates otherwise, shall have the

meanings ascribed to them in this section:

* * *

(d)  "Custom-fabricated device" shall mean 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 and which requires substantial clinical and

technical judgment in its design and fitting.

(e)  "Custom-fitted device" shall mean a prefabricated

prosthesis, orthosis or pedorthic device that is sized or

modified for use by the patient in accordance with a

prescription and which requires substantial clinical judgment

and substantive alteration for appropriate use.

(f)  "Orthotic fitter" shall mean an individual who is

licensed to practice orthotics, pursuant to a licensed

physician's written prescription, whose scope of practice is

limited to fitting:

(1)  Prefabricated cervical orthoses not requiring more than

minor modification.

(2)  Pressure gradient hose.

(3)  Trusses.

(4)  Custom-molded therapeutic footwear.

(5)  Custom-molded foot orthoses.

(6)  Prefabricated spinal orthoses, except for those used in

the treatment of scoliosis, rigid body jackets made of

thermoformable materials, and "halo" devices.

(7)  Prefabricated orthoses of the upper and lower

extremities.

(g)  "Orthotics" shall mean 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.

(h)  "Orthotist" shall mean an individual other than an

orthotic fitter licensed under this act to practice orthotics.

(i)  "Over-the-counter" shall mean a prefabricated, mass-

produced item that is prepackaged and requires no professional

advice or judgment in either size selection or use, including

fabric or elastic supports, corsets, generic arch supports and

elastic hose.

(j)  "Pedorthic device" shall mean therapeutic shoes, shoe

modifications made for therapeutic purposes, partial foot

prostheses, foot orthoses and below-the-knee pedorthic

modalities. Pedorthic devices do not include nontherapeutic,

accommodative inlays and nontherapeutic accommodative footwear,

regardless of method of manufacture; unmodified, nontherapeutic

over-the-counter shoes; or prefabricated unmodified and/or

unmodifiable foot care and foot wear products, accommodative

means designed with a primary goal of conforming to the

individual's anatomy, and therapeutic devices are devices that

address a medical condition, while nontherapeutic devices are

devices that do not address a medical condition.

(k)  "Pedorthics" shall mean shall mean evaluating, treatment

planning, patient managing, measuring, designing, fabricating,

assembling, fitting, adjusting or servicing necessary to

accomplish the application of a pedorthic device for the

prevention or amelioration of painful and/or disabling

conditions related to the lower extremities.

(l)  "Pedorthist" shall mean an individual licensed under

this act to practice pedorthics.

(m)  "Podiatrist" shall mean an individual licensed by the

board under this act.

(n)  "Prefabricated orthosis" shall mean 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.

(o)  "Prosthesis" shall mean 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.

(p)  "Prosthetics" shall mean evaluating, measuring,

designing, fabricating, assembling, fitting, adjusting or

servicing a prosthesis.

(q)  "Prosthetist" shall mean an individual licensed under

this act to practice prosthetics.

(r)  "Expungement" shall mean the removal of a disciplinary

record, accomplished by:

(1)  Permanently sealing the affected record from public

access.

(2)  Deeming the proceedings to which the affected record

refers as not having occurred.

(3)  Except with respect to any subsequent application for

expungement, affording the affected party the right to represent

that no record exists regarding the subject matter of the

affected record.

(s)  "NCCA" shall mean the National Commission for Certifying

Agencies.

(t)  "NOCA" shall mean the National Organization for

Competency Assurance.

Section 2.  Sections 5, 9.2 and 12 of the act, amended or

added December 20, 1985 (P.L.384, No.107), are amended to read:

Section 5.  Exclusive Jurisdiction of Board.--From and after

the effective date of this act, the board shall exercise

exclusive jurisdiction over all persons licensed, or to be

licensed, and registered to practice podiatric medicine,

prosthetics, orthotics, pedorthics or orthotic fitting in this

Commonwealth.

Section 9.2.  Reporting of Multiple Licensure.--Any licensed

podiatrist, prosthetist, orthotist, pedorthist or orthotic

fitter of this Commonwealth who is also licensed to practice

podiatric medicine, prosthetics, orthotics, pedorthics, orthotic

fitting or surgery in any other state, territory or country

shall report this information to the board on the biennial

registration application. Any disciplinary action taken in other

states shall be reported to the board on the biennial

registration application or within ninety days of final

disposition, whichever is sooner. Multiple licensure shall be

noted by the board on the podiatrist's record, and such state,

territory or country shall be notified by the board of any

disciplinary actions taken against said podiatrist in this

Commonwealth.

Section 12.  Practice by Unregistered Persons.--Any person

who is not a licensed, and registered as a podiatrist,

prosthetist, orthotist, pedorthist or orthotic fitter shall not

practice podiatric medicine, 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 "Chiropodist," "Podiatrist," "Prosthetist," "Orthotist,"

"Pedorthist," "Orthotic Fitter," "DSC," "DPM," "Doctor of

Podiatric Medicine," "Foot Specialist," "Foot Correctionist,"

"Pedopractor" nor any other title, name or description implying

or calculated to lead to the belief that he is qualified to

practice podiatric medicine.

Section 3.  The act is amended by adding a section to read:

Section 12.1.  Prosthetists, orthotists, pedorthists and

orthotic fitters.--(a)  To qualify for licensure to practice

prosthetics, orthotics, orthotic fitting or pedorthics, an

applicant shall:

(1)  Be of good moral character.

(2)  Possess a high school diploma or its equivalent.

(3)  Complete the amount of formal training which shall 

include any hours of classroom education and clinical practice

established and approved by a prosthetic, orthotic and pedorthic

credentialing organization recognized by NOCA and accredited by

NCCA.

(4)  Complete a qualified work experience program or

internship in prosthetics, orthotics or pedorthics in accordance

with any standards, guidelines or procedures established and

approved by the board.

(5)  Pass all examinations that are required for

certification by a prosthetic, orthotic or pedorthic

credentialing organization recognized by NOCA and accredited by

NCCA.

(6)  Have fulfilled all educational and training requirements

consistent with those required for certification by a

prosthetic, orthotic and pedorthic credentialing organization

recognized by the NOCA and accredited by the NCCA.

(7)  Paid a fee as established by the board by regulation.

(8)  Not be addicted to alcohol, narcotics or other habit-

forming drugs.

(9)  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.

The term "convicted" shall include a judgment, an admission of

guilt or a plea of nolo contendere.

(b)  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 (j). A license and a temporary practice

permit are not transferable.

(c)  Prior to administering the first treatment, a

prosthetist, orthotist, orthotics fitter or pedorthist shall do

all of the following:

(1)  Ensure the patient has secured a written referral for

treatment using prosthetics, orthotics or pedorthics from a

physician or podiatrist. A referral 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 or

podiatrist.

(3)  Keep a copy of the referral and the results of the

medical diagnostic examination in the patient's file.

(d)  Nothing in this section shall prohibit students enrolled

in a prosthetics, orthotics, orthotics fitter or pedorthics

educational program from performing prosthetics, orthotics or

pedorthics in the course of their instruction, provided a

physician or podiatrist is readily available for consultations

and that a prosthetist, orthotist or pedorthist, respectively,

is on site and responsible for the direct supervision of

students.

(e)  Nothing in this section shall prohibit faculty teaching

in a prosthetic, orthotic, orthotics fitter or pedorthic

educational program or guest lecturers from performing

prosthetics, orthotics or pedorthics in the course of student

instruction or during professional development seminars,

provided the individuals are licensed as a prosthetist,

orthotist or pedorthist in this Commonwealth or another

jurisdiction recognized by the Commonwealth and obtain temporary

licensure in this Commonwealth.

(f)  Nothing in this section shall be construed to prevent:

(1)  An occupational therapist licensed by the Commonwealth

from engaging in the practice in which the occupational

therapist is licensed.

(2)  A physical therapist licensed by the Commonwealth from

engaging in the practice in which the physical therapist is

licensed.

(3)  A physician licensed by the Commonwealth from engaging

in the practice in which the physician is licensed.

(4)  A podiatrist licensed by the Commonwealth from engaging

in the practice in which the podiatrist is licensed.

(5)  The practice of prosthetics, orthotics or pedorthics by

an individual who is employed by the Federal Government while in

the discharge of the employee's official duties.

(g)  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, orthotics

fitter or pedorthics in this Commonwealth unless the individuals

are licensed in accordance with this section.

(h)  Within two years after the effective date of this

section, individuals holding a national certification as a

prosthetist, orthotist or a prosthetist/orthotist in accordance

with this section may apply for and shall be granted prosthetic

or orthotic licensure under this section upon payment of the

required fee. Beginning two years after the effective date of

this section, applicants for licensure as a prosthetist or an

orthotist shall meet the requirements of this section.

(i)  The board may issue a temporary practice permit to an

applicant in order to permit the applicant to practice

prosthetics, orthotics, orthotics fitter or pedorthics under

this section during the six-month period immediately preceding

completion of the applicant's education program. The temporary

practice permit shall be nonrenewable and expire on the earlier

of six months from the date of issuance, or the date the

applicant fails any board required licensing examination.

(j)  To renew a license, a licensee must:

(1)  File a renewal application with the board.

(2)  Pay a fee established by regulation of the board.

(3)  For prosthestists and orthotists, provide certification

of successful completion of a minimum of twenty-four hours of

continuing education during the immediately preceding two years.

For orthotic fitters and pedorthists, provide certification of

successful completion of a minimum of thirteen hours of

continuing education during the immediately preceding two years.

Certification of continuing education credit hours submitted by

the prosthetist, orthotist, orthotic fitter or pedorthist shall

be properly signed as being correct and true. No credit may be

given for courses in office management or practice building. The

board may waive all or part of the continuing education

requirement 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.

(k)  The Department of Education shall approve any

prosthetics, orthotics, orthotics fitter or pedorthics

educational program that meets the relevant and appropriate

requirements of 22 Pa. Code (relating to education) and 24

Pa.C.S. Ch. 65 (relating to private colleges, universities and

seminaries) and that meets or exceeds the standards required for

prosthetics, orthotics, orthotics fitter or pedorthics programs

established by an accrediting agency recognized by the United

States Department of Education.

(l)  An individual licensed to practice prosthetics,

orthotics, orthotic fitting or pedorthics in this Commonwealth

shall maintain a level of professional liability insurance

coverage in the minimum amount of one million dollars

($1,000,000) per occurrence or claims made. Failure to maintain

insurance coverage as required shall subject the licensee to

disciplinary proceedings. The board shall accept from a licensee

as satisfactory evidence of insurance coverage any of the

following:

(i)  self-insurance;

(ii)  personally purchased liability insurance; or

(iii)  professional liability insurance coverage provided by

the individual licensee's employer or similar insurance coverage

acceptable to the board.

(m)  An applicant under this section shall provide proof that

the applicant has obtained professional liability insurance in

accordance with subsection (l). It is sufficient if the

applicant files with the application a copy of a letter from the

applicant's professional liability insurance carrier indicating

the applicant will be covered against professional liability in

the required amounts effective upon the issuance of the

applicant's license to practice prosthetics, orthotics, orthotic

fitting or pedorthics in this Commonwealth. Upon issuance of the

license, the licensee has thirty days to submit to the board the

certificate of insurance or a copy of the policy declaration

page.

(n)  The board may issue a license to practice prosthetics,

orthotics, orthotic fitting or pedorthics in this Commonwealth

without examination to an applicant holding a license to

practice prosthetics, orthotics, orthotic fitting or pedorthics

from another state who submits proof satisfactory to the board

the applicant:

(1)  Is of good moral character.

(2)  Meets requirements for national certification.

(3)  Holds a license to practice prosthetics, orthotics,

orthotic fitting or pedorthics that is in good standing from

another state.

(4)  Has, at a minimum, been actively engaged in the practice

of prosthetics, orthotics, orthotic fitting or pedorthics for

five of the last seven years immediately preceding the filing of

the application for licensure by endorsement with the board.

(5)  Has submitted an application accompanied by the

application fee.

(6)  Has not been convicted of a felony under "The Controlled

Substance, Drug, Device and Cosmetic Act" or 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:

(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 such that licensure of the

applicant should not be 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 violation.

(iii)  The applicant otherwise satisfies the qualifications

contained in or authorized by this act.

As used in this paragraph, the term "convicted" includes a

judgment, an admission of guilt or a plea of nolo contendere.

Section 4.  Sections 13, 16, 16.2, 18 and 19 of the act,

amended or added December 20, 1985 (P.L.384, No.107), are

amended to read: 

Section 13.  Penalties.--(a)  Any person violating any of the

provisions of this act, or any rule or regulation of the board,

shall be guilty of a misdemeanor, and, upon conviction thereof,

shall be sentenced to pay a fine of not more than one thousand

dollars ($1,000), or undergo imprisonment for not more than six

months for the first violation. On the second and each

subsequent conviction, he shall be sentenced to pay a fine of

not more than two thousand dollars ($2,000), or undergo

imprisonment for not less than six months nor more than one year

in jail, or both.

(b)  In addition to any other civil remedy or criminal

penalty provided for in this act, the board, by a vote of the

majority of the maximum number of the authorized membership of

the board as provided by law, or by a vote of the majority of

the duly qualified and confirmed membership or a minimum of four

members, whichever is greater, may levy a civil penalty of up to

[one thousand dollars ($1,000)] ten thousand dollars ($10,000) 

on any current licensee who violates any provision of this act

or on any person who practices podiatric medicine without being

properly licensed to do so under this act. The board shall levy

this penalty only after affording the accused party the

opportunity for a hearing, as provided in Title 2 of the

Pennsylvania Consolidated Statutes (relating to administrative

law and procedure).

(c)  As part of its sanction, the board may assess the costs

of investigation underlying a disciplinary action against a

respondent found in violation of the disciplinary provisions

administered by the board in a disciplinary proceeding pending

before the board for final determination. The cost of

investigation shall not include any associated legal fees or any

cost of prosecution.

Section 16.  Refusal to Grant, Suspension and Revocation.--

(a)  The board may refuse to grant and may suspend or revoke or

cancel a license or a registration for the following reasons:

(1)  The practice of fraud or deceit in obtaining or

attempting to obtain a license or in obtaining admission to a

school of podiatric medicine or surgery.

(2)  Pleading guilty or nolo contendere to, or being found

guilty, or receiving probation without verdict, disposition in

lieu of trial, or an Accelerated Rehabilitative Disposition in

the disposition of felony charges or an offense in connection

with the practice of podiatric medicine or involving moral

turpitude by a court of competent jurisdiction, or a jury.

(3)  Gross incompetency, gross immorality, negligence or

misconduct in carrying on of such profession.

(4)  Violation of any of the provisions of this act, or the

rules and regulations of the board.

(5)  Loaning, borrowing or using the registration or license

to practice podiatry of another, or knowingly aiding or abetting

in any way the granting of an improper license or registration.

(6)  That said applicant or licensee is addicted to alcohol

or drugs or has been convicted of a felonious act prohibited by

the act of April 14, 1972 (P.L.233, No.64), known as "The

Controlled Substance, Drug, Device and Cosmetic Act," or

convicted of a felony relating to a controlled substance in a

court of law of the United States or any other state, territory

or country, or if he or she is or shall become mentally

incompetent. An applicant's statement on the application

declaring the absence of a conviction shall be deemed

satisfactory evidence of the absence of a conviction unless the

board has some evidence to the contrary. In enforcing this

paragraph, the board shall, upon probable cause, have authority

to compel a podiatrist to submit to a mental or physical

examination by a physician or a psychologist approved by the

board. Failure of a podiatrist to submit to such examination

when directed by the board, unless such failure is due to

circumstances beyond his or her control, shall constitute an

admission of the allegations against him or her, consequent upon

which a default and final order may be entered without the

taking of testimony or presentation of evidence. A podiatrist

affected under this paragraph shall at reasonable intervals be

afforded an opportunity to demonstrate that he or she can resume

a competent practice of podiatry with reasonable skill and

safety to patients.

(7)  Knowingly making substantial misrepresentations.

(8)  Unethical conduct or misleading, fraudulent or unethical

advertising.

(9)  Soliciting patronage other than by legitimate

advertisement, or paying a commission or agreeing to pay a

commission to any person or persons for soliciting or for

business secured, or paying any gratuity to any person with

intent to have such person aid in securing business, or like

unprofessional conduct.

(10)  Having a license to practice podiatric medicine,

prosthetics, orthotics, pedorthics or orthotic fitting 

suspended, revoked or refused or receiving other disciplinary

action by the proper podiatry, prosthetics, orthotics,

pedorthics or orthotic fitting licensing authority of another

state, territory or country.

(11)  Acting in such a manner as to present an immediate and

clear danger to the public health or safety.

(12)  Failing to provide information, documents or records

requested by the board, or a representative of the board, in

connection with the investigation or prosecution of a

disciplinary matter under this act.

(b)  When the board finds that the license of any person may

be refused, revoked or suspended under the terms of subsection

(a), the board may:

(1)  Deny the application for a license.

(2)  Administer a public reprimand.

(3)  Revoke, suspend, limit or otherwise restrict a license

as determined by the board.

(4)  Require a licensee to submit to the care, counseling or

treatment of a physician or a psychologist designated by the

board.

(5)  Suspend enforcement of its finding thereof and place a

licensee on probation with the right to vacate the probationary

order for noncompliance.

(6)  Restore or reissue, in its discretion, a suspended

license to practice podiatric medicine and impose any

disciplinary or corrective measure which it might originally

have imposed.

Section 16.2.  Reinstatement of License, Certificate or

Registration.--Unless ordered to do so by Commonwealth Court or

an appeal therefrom, the board shall not reinstate the license,

certificate or registration of a person to practice podiatric

medicine, prosthetics, orthotics, pedorthics or orthotic fitting 

pursuant to this act which has been revoked. Any person whose

license, certificate or registration has been revoked may apply

for reinstatement after a period of at least five years but must

meet all of the licensing qualifications of this act for the

license applied for, including the examination requirement, if

he or she desires to practice at any time after such revocation.

Section 18.  Display of License and Certificate.--Every

holder of a license or certificate of registration shall display

the same in a conspicuous place wherein such person shall

practice podiatric medicine, prosthetics, orthotics, pedorthics

or orthotic fitting.

Section 19.  Injunction or Other Process.--It shall be

unlawful for any person to practice or attempt to offer to

practice podiatric medicine, prosthetics, orthotics, pedorthics

or orthotic fitting as defined in this act, without having at

the time of so doing a valid, unexpired, unrevoked and

unsuspended license issued under this act. The unlawful practice

of podiatric medicine, prosthetics, orthotics, pedorthics or

orthotic fitting, as defined in this act may be enjoined by the

courts on petition of the board or the Commissioner of

Professional and Occupational Affairs. In any such proceeding,

it shall not be necessary to show that any person is

individually injured by the actions complained of. If it is

found that the respondent has engaged in the unlawful practice

of podiatric medicine, prosthetics, orthotics, pedorthics or

orthotic fitting, the court shall enjoin him or her from so

practicing unless and until he or she has been duly licensed.

Procedure in such cases shall be the same as in any other

injunction suit. The remedy by injunction hereby given is in

addition to any other civil or criminal prosecution and

punishment.

Section 5.  The act is amended by adding a section to read:

Section 23.  Expungement.--To expunge a disciplinary record

of a certificate holder, registrant or licensee subject to the

following conditions:

(1)  The certificate holder, registrant or licensee shall

make written application to the board for expungement no earlier

than four years from the effective date of the disciplinary

record.

(2)  The disciplinary record shall be the only disciplinary

record the certificate holder, registrant or licensee has with

the board.

(3)  The certificate holder, registrant or licensee shall

have no disciplinary record previously expunged.

(4)  The disciplinary record shall have involved either the

imposition of a civil penalty against the certificate holder,

registrant or licensee for a violation under authority of

section 5(a) of the act of July 2, 1993 (P.L.345, No.48),

entitled "An act empowering the General Counsel or his designee

to issue subpoenas for certain licensing board activities;

providing for hearing examiners in the Bureau of Professional

and Occupational Affairs; providing additional powers to the

Commissioner of Professional and Occupational Affairs; and

further providing for civil penalties and license suspension",

or the imposition of discipline against the certificate holder,

registrant or licensee for a violation that, at the time of

application for expungement, would be prosecuted under authority

of section 5(a) of the act of July 2, 1993 (P.L.345, No.48).

Section 6.  This act shall take effect in 60 days.

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

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(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.

* * *

"NCCA."  The National Commission for Certifying Agencies or

its successor.

"NOCA."  The National Organization for Competency Assurance

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 a high school diploma or its equivalent.

(3)  Have fulfilled all educational and training required

for certification by a prosthetic, orthotic, pedorthic and

orthotic fitting credentialing organization recognized by

NOCA and accredited by NCCA and any additional requirements

as required by the board.

(4)  Pass all examinations that are required for

certification by a prosthetic, orthotic, pedorthic or

orthotic fitting credentialing organization recognized by

NOCA and accredited by NCCA.

(5)  Submit an application and fee 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)  Treatment requirements.--Prior to administering the

first 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 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,

if provided, 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 one of the following:

(i)  Holds a national certification as a prosthetist,

orthotist, pedorthist or orthotic fitter.

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

three years immediately preceding the effective date of

this section.

(g)  License renewal.--To renew a license, a licensee must:

(1)  File a renewal application with the board.

(2)  Pay a fee established by regulation by the board.

(3)  Complete continuing education as required by the

board. The following apply:

(i)  Certification of continuing education credit

hours submitted by the prosthetist, orthotist, pedorthist

or orthotic fitter shall be verified as being correct and

true.

(ii)  No credit may be given for courses in office

management or practice building.

(iii)  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.