HB 1391 — An Act amending the act of May 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, in casualty insurance, providing for reimbursement for custom-fabricated devices, custom-fitted devices, orthosis, orthotics, over-the-counter prostheses, orthoses and pedorthic devices, prefabricated orthoses, prostheses, prosthetics and components of such devices.

PRINTER'S NO.   1586

                     THE GENERAL ASSEMBLY OF PENNSYLVANIA



                         HOUSE BILL
                         No. 1391
                                               Session of
                                                 2025

     INTRODUCED BY GAYDOS, HANBIDGE, GALLAGHER AND BOROWSKI,
        MAY 5, 2025

     REFERRED TO COMMITTEE ON INSURANCE, MAY 5, 2025


                                    AN ACT
 1   Amending the act of May 17, 1921 (P.L.682, No.284), entitled "An
 2      act relating to insurance; amending, revising, and
 3      consolidating the law providing for the incorporation of
 4      insurance companies, and the regulation, supervision, and
 5      protection of home and foreign insurance companies, Lloyds
 6      associations, reciprocal and inter-insurance exchanges, and
 7      fire insurance rating bureaus, and the regulation and
 8      supervision of insurance carried by such companies,
 9      associations, and exchanges, including insurance carried by
10      the State Workmen's Insurance Fund; providing penalties; and
11      repealing existing laws," in casualty insurance, providing
12      for reimbursement for custom-fabricated devices, custom-
13      fitted devices, orthosis, orthotics, over-the-counter
14      prostheses, orthoses and pedorthic devices, prefabricated
15      orthoses, prostheses, prosthetics and components of such
16      devices.
17      The General Assembly of the Commonwealth of Pennsylvania
18   hereby enacts as follows:
19      Section 1.    The act of May 17, 1921 (P.L.682, No.284), known
20   as The Insurance Company Law of 1921, is amended by adding a
21   section to read:
22      Section 635.11.    Reimbursement for Custom-Fabricated Devices,
23   Custom-Fitted Devices, Orthosis, Orthotics, Over-the-Counter
24   Prostheses, Orthoses and Pedorthic Devices, Prefabricated
25   Orthoses, Prostheses, Prosthetics and Components of Such
 1   Devices.--(a)   Except to the extent coverage is provided under
 2   another policy, an individual or group health, sickness and
 3   accident insurance policy, group health insurance plan or policy
 4   or any other form of a managed or capitated care plan, policy,
 5   subscriber contract or certificate, issued by an insurer subject
 6   to 40 Pa.C.S. Ch. 61 (relating to hospital plan corporations) or
 7   63 (relating to professional health services plan corporations),
 8   the act of December 29, 1972 (P.L.1701, No.364), known as the
 9   "Health Maintenance Organization Act," or this act, which
10   provides hospital or medical and surgical coverage, shall
11   provide coverage for custom-fabricated devices, custom-fitted
12   devices, orthosis, orthotics, over-the-counter prostheses,
13   orthoses and pedorthic devices, prefabricated orthoses,
14   prostheses, prosthetics and components of such devices, when
15   prescribed by a physician, podiatrist, certified registered
16   nurse practitioner or physician assistant legally authorized to
17   issue the prescription. Prior to the initial prosthetic,
18   orthotic, pedorthic or orthotic fitting authorized under this
19   section, a prosthetist, orthotist, pedorthist or orthotics
20   fitter shall have the following duties:
21      (1)   Ensure that the patient has obtained a prescription,
22   accompanied by clinical notes for treatment, from a physician,
23   podiatrist, certified registered nurse practitioner or physician
24   assistant. The prescription may impose conditions and
25   restrictions on the course of treatment as required by sound
26   medical practice.
27      (2)   Verify that the patient has undergone a medical
28   diagnostic examination or that the results of a recently
29   performed medical diagnostic examination have been reviewed by a
30   physician, podiatrist, certified registered nurse practitioner,

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 1   or physician assistant.
 2      (3)   Retain in the patient's file a copy of the prescription
 3   and the results of the medical diagnostic examination.
 4      (b)   The benefits specified under this section may be
 5   provided through a combination of policies, contracts,
 6   certificates or riders, including major medical contracts, and
 7   shall be recognized within this Commonwealth.
 8      (c)   The following shall apply:
 9      (1)   An insurer may require preauthorization to determine the
10   medical necessity and eligibility of benefits for custom-
11   fabricated devices, custom-fitted devices, orthosis, orthotics,
12   over-the-counter prostheses, orthoses and pedorthic devices,
13   prefabricated orthoses, prostheses, prosthetics and components
14   of such devices.
15      (2)   Coverage under this section shall extend to the fitting,
16   repair or replacement of custom-fabricated devices, custom-
17   fitted devices, orthosis, orthotics, over-the-counter
18   prostheses, orthoses and pedorthic devices, prefabricated
19   orthoses, prostheses, prosthetics and components of such
20   devices, when the fitting, repair or replacement is deemed
21   medically necessary. Coverage under this section shall not be
22   provided for the fitting, repair or replacement necessitated by
23   negligence in proper care and maintenance or by an abusive act
24   committed by the individual utilizing such devices or
25   components.
26      (3)   An insurer shall require that custom-fabricated devices,
27   custom-fitted devices, orthosis, orthotics, over-the-counter
28   prostheses, orthoses and pedorthic devices, prefabricated
29   orthoses, prostheses, prosthetics and components of such devices
30   be rendered by an orthotic fitter, orthotist, pedorthist,

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 1   podiatrist or prosthetist licensed in this Commonwealth and
 2   contracted with the insurer, and that such devices and
 3   components be provided by an orthotic fitter, orthotist,
 4   pedorthist, podiatrist or prosthetist licensed in this
 5   Commonwealth and contracted with the insurer.
 6      (4)   Coverage under this section shall be required for a
 7   prosthetic, orthotic, pedorthic or orthotic fitting device
 8   designed exclusively for recreational, organized or adaptive
 9   sports purposes.
10      (5)   Coverage under this section shall remain subject to any
11   copayment, coinsurance or deductible amounts imposed by an
12   insurer subject to this section for similar coverages under the
13   same policy or contract.
14      (d)   On and after the effective date of this section,
15   Medicaid and a contracted insurer shall reimburse for custom-
16   fabricated devices, custom-fitted devices, orthosis, orthotics,
17   over-the-counter prostheses, orthoses and pedorthic devices,
18   prefabricated orthoses, prostheses, prosthetics and components
19   of such devices at the rate of reimbursement established for
20   such devices and components under the Federal Medicare
21   reimbursement schedule.
22      (e)   A physician, podiatrist, certified registered nurse
23   practitioner or physician assistant that prescribes custom-
24   fabricated devices, custom-fitted devices, orthosis, orthotics,
25   over-the-counter prostheses, orthoses and pedorthic devices,
26   prefabricated orthoses, prostheses, prosthetics and components
27   of such devices shall document the medical necessity of the
28   prescription as the proposed course of treatment.
29      (f)   As used in this section, the following words and phrases
30   shall have the meanings given to them in this subsection unless

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 1   the context clearly indicates otherwise:
 2      "Custom-fabricated device" means a prosthesis, orthosis or
 3   pedorthic device fabricated to comprehensive measurements or a
 4   mold for use by a patient in accordance with a prescription,
 5   which requires substantial clinical and technical judgment in
 6   its design, fabrication and fitting.
 7      "Custom-fitted device" means a prefabricated prosthesis,
 8   orthosis or pedorthic device sized or modified for use by a
 9   patient in accordance with a prescription, which requires
10   substantial clinical judgment and substantive alteration in its
11   design for appropriate use.
12      "Orthosis" means a custom-fabricated or custom-fitted device
13   designed to externally provide support, alignment or prevention
14   to the body or a limb for the purpose of correcting or
15   alleviating a neuromuscular or musculoskeletal disease, injury
16   or deformity.
17      "Orthotic fitter" means an individual licensed in this
18   Commonwealth to properly fit, dispense and adjust prefabricated
19   orthotic devices as authorized by a prescription from a
20   physician, podiatrist, certified registered nurse practitioner
21   or physician assistant.
22      "Orthotics" means the practice of evaluating, measuring,
23   designing, fabricating, assembling, fitting, adjusting or
24   servicing an orthosis for the correction or alleviation of
25   neuromuscular or musculoskeletal dysfunction, disease, injury or
26   deformity.
27      "Orthotist" means an individual, other than a physical
28   therapist, occupational therapist or orthotic fitter, licensed
29   in this Commonwealth to practice orthotics as authorized by a
30   prescription from a physician, podiatrist, certified registered

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 1   nurse practitioner or physician assistant.
 2      "Over-the-counter prostheses, orthoses and pedorthic devices"
 3   means prefabricated, mass-produced items that are prepackaged
 4   and require no professional advice or judgment in size selection
 5   or use, including fabric or elastic supports, corsets, generic
 6   arch supports and elastic hose.
 7      "Pedorthic device" means therapeutic shoes, shoe
 8   modifications made for therapeutic purposes, partial foot
 9   prostheses, foot orthoses and below-the-knee pedorthic
10   modalities. The term does not include nontherapeutic,
11   accommodative inlays, nontherapeutic accommodative footwear,
12   unmodified, nontherapeutic over-the-counter shoes or
13   prefabricated unmodified or unmodifiable foot care and footwear
14   products.
15      "Pedorthics" means the practice of evaluating, measuring,
16   designing, fabricating, assembling, fitting, adjusting or
17   servicing necessary to accomplish the application of a pedorthic
18   device for the prevention or amelioration of painful or
19   disabling conditions related to the lower extremities.
20      "Pedorthist" means an individual licensed in this
21   Commonwealth to practice pedorthics as authorized by
22   prescription from a physician, podiatrist certified as a
23   registered nurse practitioner or physician assistant.
24      "Podiatrist" means an individual licensed under the act of
25   March 2, 1956 (1955 P.L.1206, No.375), known as the "Podiatry
26   Practice Act," to practice podiatry.
27      "Prefabricated orthosis" means a brace or support designed to
28   provide for alignment, correction or prevention of neuromuscular
29   or musculoskeletal dysfunction, disease, injury or deformity.
30   The term does not include fabric or elastic supports, corsets,

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 1   arch supports, low-temperature plastic splints, trusses, elastic
 2   hose, canes, crutches, soft cervical collars, dental appliances
 3   or other similar devices carried in stock and sold as over-the-
 4   counter items by a drug store, department store, corset shop or
 5   surgical supply facility.
 6      "Prosthesis" means a custom-designed, custom-fabricated,
 7   custom-fitted or custom-modified device to replace an absent
 8   external limb for purposes of restoring physiological function,
 9   which is not surgically implanted. The term does not include
10   artificial eyes, ears, fingers, toes, dental appliances,
11   cosmetic devices, such as artificial breasts, eyelashes or wigs,
12   or other devices that do not significantly impact the
13   musculoskeletal functions of the body.
14      "Prosthetics" means the practice of evaluating, measuring,
15   designing, fabricating, assembling, fitting, adjusting or
16   servicing a prosthesis.
17      "Prosthetist" means an individual, other than a physical
18   therapist or occupational therapist, licensed in this
19   Commonwealth to practice prosthetics as authorized under
20   prescription from a physician, podiatrist, certified registered
21   nurse practitioner or physician assistant.
22      Section 2.   This act shall apply as follows:
23          (1)   For health insurance policies for which either rates
24      or forms are required to be filed with the Federal Government
25      or the Insurance Department, this act shall apply to any
26      policy for which a form or rate is first filed on or after
27      180 days after the effective date of this paragraph.
28          (2)   For health insurance policies for which neither
29      rates nor forms are required to be filed with the Federal
30      Government or the Insurance Department, this act shall apply

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1      to any policy issued or renewed on or after 180 days after
2      the effective date of this paragraph.
3      Section 3.   If a State plan amendment or Federal waiver
4   necessary for the provisions of this act is approved or is not
5   necessary, the Secretary of Human Services shall transmit a
6   notice to the Legislative Reference Bureau for publication in
7   the next available issue of the Pennsylvania Bulletin.
8      Section 4.   This act shall take effect in 60 days.




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