101 CMR, § 334.02

Current through Register 1533, October 25, 2024
Section 334.02 - General Definitions

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. See101 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. SeeDirect 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).

101 CMR, § 334.02

Amended by Mass Register Issue 1381, eff. 12/28/2018.
Amended by Mass Register Issue 1518, eff. 4/1/2024.