Code of Massachusetts Regulations › 101 CMR - EXECUTIVE OFFICE FOR HEALTH AND HUMAN SERVICES › Title 101 CMR 334.00 - Rates for Prostheses, Prosthetic Devices, and Orthotic Devices › Section 334.02 - General Definitions

Current through Register 1525, July 5, 2024
Meaning of Terms
. Terms used in 101
				CMR 334.00 have the meanings set forth in 101 CMR 334.02.
ABC.
American Board for Certification
				in Orthotics and Prosthetics.
Additions to
. If a code is listed as
				"Additions to", the code is added to the base procedure code if additional and
				more complicated services are provided. The value assigned to the "Additions
				to" codes does not represent the actual value of the component but only the
				difference in value between the base procedure code and the additional
				component.
Adjusted Acquisition Cost (A.A.C.)
.
				The price paid to a supplier by a provider for prostheses, prosthetic devices
				and orthotic devices after adjusting for quantity discounts and excluding all
				associated costs such as, but not limited to, shipping, handling, and insurance
				costs,
etc
. A.A.C. does not exceed the price to the Provider
				as listed or determined in the manufacturer's current catalogue and must be
				evidenced by a current invoice. Where the manufacturer is the Provider, the
				A.A.C. cannot exceed the actual cost of raw materials. Low cost items (those
				with an A.A.C. less than $5.00) may be grouped together and billed at $5.00,
				plus the mark-up listed in 101 CMR 334.02:
Individual
				Consideration
.
Above Elbow (AE) Trans-humeral
.
				Relating to prostheses or levels of amputation across the long axis of the
				humerus.
AFO
. Ankle foot orthosis.
Above Knee (AK) Trans-femoral
.
				Relating to prostheses or levels of amputation across the long axis of the
				femur.
Additions to
. If a code is listed as
				"Additions to", the code is added to the base procedure code if additional and
				more complicated services are provided. The value assigned to the "Additions
				to" codes does not represent the actual value of the component but only the
				difference in value between the base procedure code and the additional
				component.
Adjusted Acquisition Cost (AAC)
. The
				price paid to a supplier by a provider for prostheses, prosthetic devices and
				orthotic devices after adjusting for manufacturer, dealer, trade, and volume
				discounts and excluding all associated costs such as, but not limited to,
				shipping, handling, and insurance costs. The AAC may not exceed the price to
				the provider as listed or determined in the manufacturer's current catalogue
				and must be evidenced by a current invoice. The standard markup applied to the
				AAC corresponds to the complexity of the item and are set forth in 101 CMR
				334.02.
Ankle Foot Orthosis (AFO)
. An orthosis
				beginning at the toes, crossing the ankle, and terminating on the calf. Devised
				to control, limit, or assist foot and ankle motion and provide leg
				support.
American Board for Certification in Orthotics,
				Prosthetics, and Pedorthics (ABC)
. An accrediting organization for
				orthotic, prosthetic, and pedorthic services.
Base Code
. A code that describes the
				essential or fundamental design of a device.
Below Elbow (BE) Trans-radial
.
				Relating to prostheses or levels of amputation across the long axis of the
				radius/ulna.
Below Knee (BK) Trans-tibial
. Relating
				to prostheses or levels of amputation across the long axis of the
				tibia/fibula.
Bilateral
. Of, or pertaining to, both
				sides of the body.
BK (Below Knee) Trans-tibial
. Relating
				to prostheses or levels of amputation across the long axis of the
				tibia/fibula.
BOC
. Board for Orthotics/Prosthetic
				Certification.
BCP
. Board for Certification in
				Pedorthics.
Board of Certification/Accreditation
				(BOC)
. An accrediting organization for prosthetic and orthotic
				services.
Center
. The Center for Health
				Information and Analysis established under M.G.L. c. 12C.
Cervical Orthosis (CO)
. Orthosis that
				traverses the cervical vertebrae.
Cervical-thoracic Orthosis (CTO)
.
				Orthosis that traverses the listed areas.
Cervical-thoracic-lumbar-sacral Orthosis
				(CTLSO)
. Orthosis that traverses the listed areas.
Cross-walk
. A cross-reference in which
				a code is deleted and replaced with another code or series of codes.
Custom Fabricated Device
. A device or
				product made for a specific patient from his/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 modification for fitting by a certified orthotist
				or an individual who has equivalent specialized training.
Definitive Prosthesis
. A prosthesis
				intended for long-term use containing components suitable for the full range of
				functional activities the amputee may be able to perform.
Direct Formed
. Material is molded over
				the involved portion of the patient's body and ultimately used as an essential
				part of the device.
Dynamic Response
. A prosthetic foot
				with a spring keel which deflects under load and returns to neutral.
Early Fitting
. A prosthetic device
				provided during the initial wound healing phase following amputation.
Elastic Keel Foot
.
See
Flexible Keel Foot.
Elastic Type Material Being
. Of, or
				with properties similar to, elastic.
Elbow Orthosis (EO)
. Orthosis that
				traverses the elbow.
Endoskeletal
. A prosthesis composed of
				an internal pylon system which provides structural integrity to the
				device.
Energy Storing Foot
. A prosthetic foot
				designed to collect a substantial amount of strain energy and return it to the
				gait cycle via deflection on the foot.
EOHHS
. The Executive Office of Health
				and Human Services established under M.G.L. c. 6A.
Exoskeletal
. A prosthesis composed of
				a rigid external shell that provides structural integrity to the device.
Fabrication and Fitting
. Time spent in
				examining the patient; making necessary patterns and measurements; and
				performing fittings, including static and dynamic alignments and fitting
				refinements.
Finger Orthosis or Foot Orthosis (FO)
.
				Orthosis that traverses the finger or the foot. While this abbreviation
				represents two types of orthoses, these two types of orthoses are so different
				that the context will clearly indicate which is meant.
Flexible
. Referring to devices which
				are bendable in nature and occasionally reinforced with stays of metal or other
				semi-rigid materials.
Flexible Keel Foot
. A prosthetic foot
				with a compliant, elastomeric keel which absorbs forces during rollover.
Governmental Unit
. The Commonwealth,
				any department, agency, board or commission of the Commonwealth, and any
				political subdivision of the Commonwealth.
Hand-finger Orthosis (HFO)
. Orthosis
				that traverses the listed areas.
Hand Orthosis (HO)
. Orthosis that
				encompasses the whole or any part of the hand.
Heavy Duty
. Being of stronger nature
				than standard.
Hemi Pelvectomy - Trans-pelvic
.
				Relating to an amputation which is performed through a portion of the pelvis or
				a prosthesis for this type of amputation.
Hip Disarticulation (HD)
. An
				amputation through the hip joint or to describe a prosthesis for this level of
				amputation.
Hip-knee-ankle-foot Orthosis (HKAFO)
.
				Orthosis that traverses the listed areas.
Immediate Fitting
. Beginning
				prosthetic management immediately following surgical closure of the
				wound.
Individual Consideration (I.C.)
.
				Services or devices designated I.C. are items individually considered by the
				purchasing governmental unit based on the provider's report of services. The
				purchasing governmental unit analyzes the provider's report of services
				submitted before making a determination. Providers must keep adequate records
				to substantiate their I.C. claims and must provide these documents including a
				copy of current invoice to the purchasing agency upon demand.
See
101 CMR 334.02 for the definition of
Standard
				Markup
and
				101
				CMR 334.03(8):
AAC
				Methodology and Documentation
.
(a) the provider's usual and customary charge;
(b) the A.A.C. to the provider, plus a markup not to
				exceed:
1. 70% for any item described as being custom
				fabricated;
2. 50% for any item described as being prefabricated; or
3. 40% for any item described as being off-the-shelf.
(c) Such schedule of allowable fees as may be issued as an
				amendment or revision to
				101 CMR 334.00.
Initial
. Direct formed prosthetic
				devices provided as early as patient management.
Interface Material
. Flexible lining
				material integral to the device.
Knee-ankle-foot Orthosis (KAFO)
.
				Orthosis that traverses the listed areas.
Knee Disarticulation (KD)
. Relating to
				an amputation that is performed through the knee joint or a prosthesis for his
				type of amputation.
Knee Orthosis (KO)
. Orthosis that
				traverses the knee.
Lumbar-sacral Orthosis (LSO)
. Orthosis
				that traverses the listed areas.
Molded Socket
. In orthotics, this term
				refers to an impression that was taken and modified, and that a socket of
				thermoplastic or other material was made over the model. In prosthetics, this
				term refers to a generally accepted fitting procedure, such as PTB or
				quadrilateral socket, was molded over a modified patient model.
Molded to Patient
.
See
Direct Formed
.
Molded to Patient Model
. Custom
				manufactured item individually fabricated over a positive model of the patient,
				based on a three-dimensional negative impression or digital scanning.
Multiaxial
. Having two or more axes of
				rotation.
Multi-density
. Composed of two or more
				materials of varying shore hardness.
Multi-durometer
. Composed of two or
				more materials, with sectional areas of differing shore hardness.
Non-removable
. Attached to shoe when
				the device is permanently affixed and therefore a part of the shoe.
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 a certified orthotist
				or an individual who has specialized training to adjust the device.
Orthosis
. Externally applied device
				used to modify the structural and functional characteristics of the
				neuromuscular and skeletal systems.
Passive
. A device that cannot be
				actively moved.
Polycentric
. Having many centers of
				rotation in a single plane.
Prefabricated
. A device that has been
				manufactured from standard molds or patterns.
Premolded
.
See
Prefabricated.
Preparatory
. A prosthetic device
				applied to prepare the limb for eventual fitting and to evaluate the
				appropriateness of selected technology and the patient's ability to use a
				definitive prosthesis.
Production
.
See
Prefabricated.
Prosthesis
. Externally applied device
				used to replace wholly, or in part, an absent or deficient body segment.
Provider
. Any person, partnership,
				corporation, or other entity that is authorized by the Commonwealth of
				Massachusetts to engage in the business of providing prosthetic, orthotic, or
				pedorthic services and related supplies. An eligible provider of prosthetic,
				orthotic, or pedorthic services and related supplies must be ABC-certified or
				BOC-certified and must meet the conditions of participation adopted by the
				purchasing governmental unit.
Publicly Aided Individual
. A person
				for whose medical and other services a governmental unit is in whole or in part
				liable under a statutory program.
Recall
. An action taken by the
				manufacturer to retrieve, replace, or repair dangerous ordefective orthotic or
				prosthetic devices whether or not such action is taken at the direction of the
				Food and Drug Administration (FDA).
Retail Price
. The total price charged
				for a product sold to a customer, which includes the manufacturer's cost plus a
				retail markup.
Rigid
. Not bending; inflexible.
Sale Price
. The price at which
				something sells or is sold after its retail price has been reduced.
Semi-rigid
. Partially rigid; having
				some rigid elements.
Shelf Price
. The sign or tag placed by
				an authorized person at each point of display that clearly sets forth the
				retail price of the item.
Shoulder-elbow-wrist-hand Orthosis
				(SEWHO)
. Orthosis that traverses the listed areas.
Shoulder Orthosis (SO)
. Orthosis that
				traverses the shoulder.
Single Axis
. Having only one axis of
				rotation.
Standard Markup
. Except where
				otherwise indicated in an applicable section of101 CMR
				334.03, the standard markup for the purchase
				of prostheses, prosthetic devices, and orthotic devices that is applied to the
				AAC, net of any discounts as specified in the definition of AAC at 101 CMR
				334.02, to a supplier by an eligible provider cannot exceed:
(a) 70% for any item described as being
			 custom fabricated; or
(b) 50% for
			 any item described as being prefabricated; or
(c) 40% for any item described as being
			 off-the-shelf.
Thermoplastic
. Able to be remolded
				with the application of heat.
Thoracic-lumbar-sacral Orthosis
				(TLSO)
. An orthosis that traverses the listed areas.
Thoracic Orthosis (TO)
. An orthosis
				that traverses the thoracic vertebrae.
Ultra-light Material
. Materials such
				as titanium, carbon fiber, or equal.
Unilateral
. Being of, or pertaining
				to, one side of the body.
Usual and Customary Charge
. The lowest
				price that an eligible provider charges to any payer in Massachusetts other
				than for publicly aided individuals for the same equipment or item, including
				but not limited to the shelf price, sale price, or advertised price.
Wrist-hand Orthosis (WHO)
. Orthosis
				that traverses the wrist and hand. Sometimes referred to as wrist orthosis
				(WO).