Code of Massachusetts Regulations › 130 CMR - DIVISION OF MEDICAL ASSISTANCE › Title 130 CMR 442.000 - Orthotics Services › Section 442.402 - Definitions

Current through Register 1525, July 5, 2024
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
.
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.
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.
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, §§ 1919(a), (b), (c) and
				(d).
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 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 MassHealth or its designee. The
Orthotics Manual
, Subchapter 6 directs providers to the
				Orthotics and Prosthetics Payment and Coverage Guidelines Tool.
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 Provider
- an organization
				or individual that has enrolled with MassHealth and has signed a provider
				contract with the MassHealth agency who meets all applicable requirements of
				130
				CMR 442.404 and
				450.000:
Administrative and Billing Regulations
. Orthotics providers
				may include providers also enrolled as MassHealth participating durable medical
				equipment (DME) and supplies providers, oxygen and respiratory therapy
				equipment and supplies (OXY) providers, or prosthetic services providers, who
				meet all program-specific requirements.
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. Only a DO or a doctor of medicine (MD) can prescribe
				Therapeutic Shoes for Diabetics.
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
				130
				CMR 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.