442.402 - Definitions

442.402. Definitions

The following terms used in 130 CMR 442.000 have the meanings given in 130 CMR 442.402 unless the context clearly requires a different meaning. Conditions of coverage and payment for services defined in 130 CMR 442.000 are not determined by these definitions, but by application of regulations elsewhere in 130 CMR 442.000 and 130 CMR 450.000: Administrative and Billing Regulations.

Accessory Equipment - equipment that is fabricated primarily and customarily to modify or enhance the usefulness or functional capability of another piece of orthotic or pedorthic equipment and that is generally not useful in the absence of such orthotic or pedorthic equipment.

Adjusted Acquisition Cost - except where the manufacturer is the provider, the price paid by the provider to the manufacturer or any other supplier for orthotic or pedorthic devices, customized equipment, or supplies, excluding all associated costs such as shipping, handling, and insurance costs in accordance with 101 CMR 334.00: Prostheses, Prosthetic Devices and Orthotic Devices. As provided in 101 CMR 334.00, where the manufacturer is the provider, the adjusted acquisition cost cannot exceed the actual cost of the raw materials.

American Board for Certification in Orthotics, Prosthetics and Pedorthics, Inc. (ABC) - a national certifying and accrediting body for the orthotic, prosthetic and pedorthic professions recognized as a deemed authority for facility accreditation by CMS.

American Standard Last Sizing Schedule - the numerical shoe sizing system used for shoes in the United States.

Board of Certification/Accreditation International (BOC) - BOC is an independent certifying and accrediting body for practitioners and suppliers of comprehensive orthotic and prosthetic care, and is recognized as a deemed authority for facility accreditation by CMS.

Centers for Medicare and Medicaid Services (CMS) - a federal agency responsible for administering the Medicaid and Medicare programs created under the authority of Title XIX of the Social Security Act (42 U.S.C. 1396), Title XXI of the Social Security Act (42 U.S.C. 1397), and Title XVIII of the Social Security Act (42 U.S.C. 1395-1395pp).

Consignment Closet - an arrangement in which an orthotics provider maintains inventory at a prescribing provider's location, which is not the orthotics provider's service facility, for delivery to members on behalf of the orthotics provider.

Custom-fabricated - an orthotic made for a specific patient from his or her individual measurements and/or pattern.

Custom-fitted/prefabricated - a prefabricated device or product that has been manufactured from standard molds or patterns and that requires substantial modification for fitting from an ABC- or BOC-certified orthortist or an individual who has equivalent specialized training.

Custom-molded Shoe - an individually patterned shoe fabricated to meet the specific needs of an individual. A custom-molded shoe is not off-the-shelf, stock, or prefabricated. The shoe is individually constructed by a molded process over a modified positive model of the individual's foot. It is made of leather or other suitable material of equal quality, has removable customized inserts that can be replaced if necessary according to the individual's condition, and has some form of shoe closure.

Date of Service - the date of service as specified in 130 CMR 442.424, as applicable, for delivery of the final orthotic product or service to the member, or as specified in 130 CMR 442.406(D), consistent with 130 CMR 450.231: General Conditions of Payment, for custom fabricated items ordered but not furnished to a member.

Detailed Written Order - the written prescription and statement of medical necessity justification for the specified orthotic services from the member's prescribing provider that meets the requirements at 130 CMR 442.409.

Diabetic Shoes - therapeutic footwear prescribed to prevent or alleviate painful or disabling conditions associated with diabetes by minimizing pressure on the foot.

Discount - any remuneration or reduction of payment of any kind, whether direct or indirect, received by the provider.

EOHHS - the Executive Office of Health and Human Services established under M.G.L. c. 6A.

Fitter of Therapeutic Shoes for Diabetics - an individual who is educated and trained in the provision of non-custom therapeutic shoes for diabetics and non-custom multi-density inserts including patient assessment, formulation of a treatment plan, implementation of the treatment plan, follow-up and practice management.

Foot Deformity - a deformity of the foot that may be congenital or acquired, where the foot is no longer in normal anatomical position, proportion or alignment.

Healthcare Common Procedure Coding System (HCPCS) - for purposes of 130 CMR 442.000, HCPCS refers to the Level II HCPCS codes which are maintained by CMS, adopted by the MassHealth agency and used by providers to bill for certain medical services, devices, and supplies, including all orthotic services.

Home - for the purposes of the provision of orthotics, a member's home may be a dwelling owned or rented by the member, a relative's or other person's home in which the member resides, a rest home, assisted living, or another type of group residence in a community setting in which normal life activities take place. A home does not include an institutional setting including, but not limited to, a hospital, nursing facility or Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID) or any setting in which payment is or could be made under Medicaid inpatient services that includes room and board, except for items that are allowable pursuant to 130 CMR 442.410.

Hospital - a facility that is licensed or operated as a hospital by the Massachusetts Department of Public Health or the Massachusetts Department of Mental Health that provides diagnosis and treatment on an inpatient or outpatient basis for patients who have any of a variety of medical conditions.

Initial Order - a written, electronically submitted or documented verbal communication from the member's prescribing provider to the provider of orthotics to assess and evaluate the member for the specified orthotic service, and which meets the requirements of 130 CMR 442.409.

Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID) - a facility, or distinct part of a facility, that provides intermediate care facility services as defined under 42 CFR 440.150, and that meets Federal conditions of participation, and is licensed by the State primarily for the diagnosis, treatment, or rehabilitation for individuals with intellectual disabilities; and provides, in a protected residential setting, ongoing evaluation, planning, 24-hour supervision, coordination, and integration for health or rehabilitative services to help individuals function at their greatest ability.

Last - a model that approximates the shape and size of the foot and over which a shoe is made. A last is usually made of wood, plastic, or plaster.

MassHealth - the medical assistance and benefit programs administered by EOHHS pursuant to Title XIX of the Social Security Act (42 U.S.C. 1396), Title XXI of the Social Security Act (42 U.S.C. 1397), M.G.L. c.118E, and other applicable laws and waivers to provide and pay for medical services to eligible members.

Medicare - a federally administered health insurance program for persons eligible under the Health Insurance for the Aged Act, Title XVIII of the Social Security Act (42 U.S.C. 1395-1395pp).

Member - a person determined by the MassHealth agency to be eligible for MassHealth.

Moldable Shoe - an off-the shelf, ready-made shoe formed from heat-activated materials. The shoe is molded by a thermo-forming process that first heats the material, then forms it over an individual's foot or a positive model of the individual's foot.

Nonstandard Size (Width or Length) - a shoe size made on a standard last pattern, but which is not part of a manufacturer's regular inventory.

Nursing Facility (NF) - an institution or distinct part of an institution licensed and certified for participation in Medicaid and Medicare by the Massachusetts Department of Public Health that is primarily engaged in providing skilled nursing care and related services for residents who require medical or nursing care, rehabilitation services for the rehabilitation of injured people, people with disabilities, or sick persons, or on a regular basis, health-related care and services to individuals who because of their mental or physical condition require care and services that meets the requirements of the Social Security Act, ยงยง 1919(a), (b), (c) and (d).

Nursing Facility - a licensed facility that meets the provider-eligibility and certification requirements of 130 CMR 456.404 or 456.405 and whose members meet the medical eligibility criteria under 130 CMR 456.409. Nursing facilities do not include facilities such as rest homes, state schools, and state hospitals.

Nursing Facility Visit - a visit by a provider to a nursing facility for the purpose of providing orthotic and pedorthic services.

Nurse Practitioner - a registered nurse who has successfully completed a formal education program for nurse practitioners as required by the Massachusetts Board of Registration of Nursing (the Board), who is in good standing with the Board, and who is responsible for oversight of the member's health care. A nurse practitioner who prescribes medication must be certified by the federal Drug Enforcement Agency (DEA).

Off-the-shelf - A prefabricated device or product that requires minimal self-adjustment as defined at 42 CFR 414.402 for appropriate use, i.e., does not require the services of an ABC- or BOC-certified orthotist or an individual who has equivalent specialized training to adjust the device.

Off-the-shelf Shoe - a shoe that is made on a standard last and is a regular part of a manufacturer's or provider's inventory.

Orthopedic Shoes - shoes that are specially constructed to aid in the correction of a deformity of the musculoskeletal structure of the foot and to preserve or restore the function of the musculoskeletal system of the foot.

Orthosis - a device that is:

(1) used to support, align, correct, or prevent deformities of the body, which may be used to eliminate, control, or assist motion at a joint or body part; and

(2) appropriate for use in the member's home or any setting in which normal life activities take place in the community.

Orthotic Assistant - an individual educated and trained to participate in comprehensive orthotic care while under the supervision of an ABC- or BOC-certified orthotist. An orthotic assistant may perform orthotic procedures and related tasks in the management of members, including fabricating repairs and maintaining orthotic devices to provide maximum fit and function.

Orthotic Services - the provision, purchase, customization, fitting, repair, replacement, or adjustment of an orthosis, orthotic supply, device, or component part, or other activity performed in accordance with 130 CMR 442.000.

Orthotic Supplies - products that are:

(1) fabricated primarily and customarily to fulfill a medical or surgical need;

(2) used in conjunction with an orthosis or orthotic equipment;

(3) generally not useful in the absence of an orthosis; and

(4) nonreusable and disposable.

Orthotics - products that are fabricated primarily and customarily to fulfill a medical or surgical need, and are generally not useful in the absence of illness, injury or disability. Pedorthic Services are a subset of Orthotics.

Orthotics Fitter - an individual who is educated and trained in the provision of certain prefabricated orthoses, including patient assessment, formulation of a treatment plan, implementation of the treatment plan, follow-up and practice management.

Orthotics and Prosthetics Payment and Coverage Guidelines Tool - MassHealth web-based application that contains orthotics and prosthetics service descriptions for products, services, applicable modifiers, place-of-service codes, prior authorization requirements, individual consideration requirements, service limits, markup information, and links to other applicable information, such as MassHealth pricing information and additional or updated guidance issued by the MassHealth agency or its designee. The Orthotics Manual, Subchapter 6 directs providers to the Orthotics and Prosthetics Payment and Coverage Guidelines Tool.

Orthotist - An individual who is noncertified or ABC- or BOC-certified, and is specifically educated and trained to manage comprehensive orthotic care, including patient assessment, formulation of a treatment plan, implementation of the treatment plan, follow-up and practice management.

Pedorthic Service - a subset of orthotic services involving the design, manufacture, modification, and fitting of orthopedic shoes, or the fitting of therapeutic shoes for diabetics, including foot orthoses, prosthetic fillers, and orthotic or pedorthic appliances for use from the ankle and below, for the prevention or amelioration of painful and/or disabling conditions of the foot and ankle, and as provided in accordance with 130 CMR 442.000.

Pedorthist - an individual who is noncertified or ABC- or BOC-certified, and is specifically trained and educated to manage comprehensive pedorthic care, including patient assessment, custom-molding, formulation of a treatment plan, implementation of a treatment plan, follow-up and practice management.

Physician Assistant - a mid-level medical practitioner who works under the supervision of a licensed physician (MD) or osteopathic physician (DO) and who is licensed to practice as a physician assistant by the Massachusetts Board of Registration of Physician Assistants or by the licensing agency of another state, and provides health care services to the member.

Prescribing Provider - a physician, doctor of osteopathy (DO), nurse practitioner, physician assistant, or podiatrist who prescribes and writes the prescription for all orthotics and orthotic services.

Pricing, Data Analysis, and Coding (PDAC) - a CMS contractor that evaluates and processes coding verification applications from manufacturers for Durable Medical Equipment Prosthetics, Orthotics and Supplies (DMEPOS) for Medicare purposes. The PDAC also establishes, maintains and updates all coding verification decisions on the PDAC Product Classification List that is available on the Durable Medical Equipment Coding System (DMECS), which is an official source for Medicare DMEPOS product code verification and HCPCS service code assignment, and also provides coding guidance on the appropriate HCPCS service codes for DMEPOS suppliers to use when submitting DMEPOS claims to Medicare, including for orthotics.

Proof of Delivery (POD) - documentation, such as a delivery slip, that indicates that the orthotics provider delivered, or had shipped, to a specified MassHealth member, the orthotics that were intended for that member, and that the member received the orthotics.

Prior Authorization (PA) Request - a request submitted by the orthotics provider, to the MassHealth agency to determine medical necessity in accordance with 130 CMR 442.412, 450.204: Medical Necessity, and 450.303: Prior Authorization.

Service Facility - an orthotics provider's place of business (excludes a member's place of residence), where MassHealth members can obtain all orthotic services, including those involving fitting, adjustment, repair, and replacement of orthoses.

Split-size Charge - an additional charge for dispensing an off-the-shelf, medical-grade pair of orthopedic shoes, where one shoe in the pair is a different size or width than the other shoe in the pair.

Therapeutic Shoes for Diabetics - therapeutic footwear prescribed by the prescribing provider to prevent or alleviate painful or disabling conditions associated with diabetes by minimizing pressure on the foot.

(Amended by Mass Register Issue 1395, eff. 7/12/2019.)

The following state regulations pages link to this page.