Code of Massachusetts Regulations › 101 CMR - EXECUTIVE OFFICE FOR HEALTH AND HUMAN SERVICES › Title 101 CMR 322.00 - Rates for Durable Medical Equipment, Oxygen and Respiratory Therapy Equipment › Section 322.02 - General Definitions

Current through Register 1525, July 5, 2024
Meaning of Terms
. Terms used in
				101 CMR
				322.00 have the following meanings:
Accessories
. Products that are used
				primarily and customarily to modify or enhance the usefulness or functional
				capability of durable medical equipment and that are generally not useful in
				the absence of durable medical equipment.
Adjusted Acquisition Cost (AAC)
. The
				price paid to a supplier by an eligible provider for durable medical equipment,
				medical and surgical supplies, customized equipment, oxygen and respiratory
				therapy systems or devices and related supplies, enteral and intravenous
				therapy, equipment, and related supplies excluding all associated costs such
				as, but not limited to, shipping, handling, sales tax, and insurance costs. The
				adjusted acquisition cost must reflect all discounts, including but not limited
				to manufacturer, dealer, trade, and volume discounts, including rebates, in
				whatever form, extended to the provider for the purchase of the covered item.
				The only discount that does not have to be passed on to the governmental unit
				is the amount allowed to the provider that is attributable to a timely payment
				to the manufacturer or supplier, not to exceed 5% of the AAC. The methodology
				for pricing at AAC is set forth in
				101
				CMR 322.03(17).
Advertised Price
. The price of a
				product or service as displayed or announced in a print, radio, television, or
				online advertisement.
Assistive Technology Professional
				(ATP)
. An individual with experience in assistive/ rehabilitation
				technology and certification by the Rehabilitation Engineering and Assistive
				Technology Society of North America who analyzes the equipment needs of persons
				with disabilities, assists in the selection of equipment, and trains the person
				with a disability on how to use the specific equipment. This equipment may
				include manual and power wheelchairs, seating and alternative positioning,
				ambulation assistance, environmental control, alternate computer access,
				augmentative and alternative communication devices, and products of daily
				living.
Capped Rentals
. Capped rental items
				are designated with the modifiers KH, KI, and KJ in the "code" column of
				101 CMR
				322.06 and are rented for a maximum period of
				13 months, at which point the provider stops billing and turns over ownership
				and all warranty information to the consumer. The provider may bill for repairs
				as needed to maintain the proper working condition of the equipment for the
				consumer's use after ownership turns over to the consumer.
Center
. The Center for Health
				Information and Analysis established under M.G.L. c. 12C.
Cross-walk
. A cross-reference in which
				a code is deleted and replaced with another code.
Customized Equipment
. Durable medical
				equipment that:
(a) is uniquely
			 constructed, adapted or modified solely for the full-time use of the patient
			 for whom it is purchased;
(b) is
			 made to order or adapted to meet the specific needs of the patient;
			 and
(c) the unique construction,
			 adaptation or modification of which permanently precludes the use of such
			 equipment by another individual.
Durable Medical Equipment (DME)
.
				Equipment that:
(a) is used primarily
			 and customarily to serve a medical purpose;
(b) is generally not useful in the absence of
			 disability, illness and injury;
(c)
			 can withstand repeated use over an extended period of time; and
(d) is appropriate for home use (any setting
			 in which normal life activities take place).
Eligible Provider
. Any person,
				partnership, corporation, or other entity that is authorized by the
				Commonwealth of Massachusetts to engage in the business of furnishing durable
				medical equipment, medical and surgical supplies, customized equipment, oxygen
				or respiratory therapy equipment, mobility systems, intravenous and enteral
				therapy equipment, and related supplies and services and who meets such
				conditions of participation as may be adopted by a governmental unit.
EOHHS
. The Executive Office of Health
				and Human Services established under M.G.L. c. 6A.
Governmental Unit
. The Commonwealth,
				any department, agency, board, or commission of the Commonwealth, and any
				political subdivision of the Commonwealth.
Home Infusion Therapy (HIT) Services
.
				The administration of medications to a patient in a home setting using delivery
				devices through intravenous, subcutaneous, or epidural routes. Drug therapies
				commonly administered include antibiotics, chemotherapy, pain management,
				parenteral nutrition, and immunoglobulin.
Individual Consideration (I.C.)
. Items
				for which there is no specified rate or when otherwise designated by EOHHS are
				individual consideration and are subject to the following procedure. The
				purchasing governmental unit analyzes the eligible 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 the current invoice, to the purchasing agency. The
				methodology for pricing at I.C. is set forth in
				101 CMR
				322.03(19).
Liquid Oxygen System
. Respiratory
				therapy equipment utilizing liquid oxygen.
Medical Supplies
. Consumable or
				disposable supplies or devices for home use, necessary for the treatment of a
				specific illness, injury, disease, or disability including, but not limited to,
				test strips, syringes, ostomy products, and surgical items that are:
(a) required to address an individual medical
			 disability, illness, or injury;
(b)
			 cannot withstand repeated use by more than on individual;
(c) generally not useful in the absence of
			 illness or injury;
(d) consumable or
			 disposable; and
(e) appropriate for
			 use in any setting in which normal life activities take place.
Mobility System
. A manual or power
				wheelchair or other wheeled device, such as a scooter, including a base, a
				seating system, its components, accessories, and modifications.
Oxygen
. Gaseous or liquid medical
				grade oxygen that conforms to United States Pharmacopeia Reference
				Standards.
Oxygen Delivery Systems
. A
				comprehensive oxygen service that includes, but is not limited to: the
				gaseous/liquid oxygen, oxygen generating device and related delivery systems
				container or cylinder, manifold systems whenever high volume oxygen is used,
				stand, cart, walker/stroller, supply reservoir, contents indicator, regulator
				with flow gauge, humidification devices, cannulas, masks, and special oxygen
				administration device, tubing and refill adapter.
Oxygen Generating Device
. Any device
				suitable for domiciliary use that produces oxygen by any chemical or physical
				means such as, but not limited to, oxygen concentrators, and oxygen enrichers,
				and that conforms to such standards as may be required by federal and state
				governmental units.
Patient Lift System
. A hoist, jack
				hoist, or hydraulic lift which may be either a sling lift (or Hoyer Lift, a
				brand name, used for patients whose mobility is limited) or sit-to-stand lift,
				which may be mobile (floor) lifts or overhead lifts (suspended from
				ceiling-mounted or overhead tracks).
Positioning System
. Equipment
				prescribed to meet a medical need and intended to provide an alternative
				position to the seated wheelchair position.
Preferred Supplier Contract
. A
				contract between a supplier of durable medical equipment or medical supplies
				and EOHHS or another governmental unit under which the supplier agrees to
				supply specified durable medical equipment or medical supplies at specified
				rates to certain eligible providers defined by the contract.
Prescribing Provider
. The member's
				physician, nurse practitioner, clinical nurse specialist, or physician's
				assistant who prescribes and writes the prescription.
Publicly Aided Individual
. A person
				for whose medical and other services a governmental unit is in whole or in part
				liable under a statutory public program.
Rate
.
See
101 CMR
				322.03 and
				322.06.
Rebate Agreement
. An agreement by
				which a manufacturer of durable medical equipment or medical supplies agrees to
				pay EOHHS or another governmental unit a rebate related to payments for
				specified durable medical equipment or medical supplies by the relevant
				government unit or units to certain eligible providers defined in the
				agreement.
Recall
. An action taken by the
				manufacturer to retrieve, replace, or repair dangerous or defective DME,
				whether or not such action is taken at the direction of the Food and Drug
				Administration (FDA).
Request for Prior Authorization
. A
				request by a provider, as required by the governmental unit, that the
				government unit determine the medical necessity of specified equipment or
				supplies for a particular individual. The provider must submit any such request
				to the governmental unit in accordance with all applicable laws, regulations
				and policies.
Respiratory Therapy Devices and
				Supplies
. Those modalities and necessary ancillary equipment used
				in the care and treatment of pulmonary insufficiencies from whatever cause as
				may be ordered by the prescribing provider for their therapeutic and remedial
				effect, and that meet such standards as may be required by federal or state
				governmental units. Respiratory therapy devices include, but are not limited
				to, the complete device and related delivery system accessories, including,
				regulator with flow gauge, humidification and heating units, filters, cannulas,
				masks, and special administration device tubing and adapters.
Retail Price
. The total price charged
				for a product sold to a customer, which includes the manufacturer's cost plus a
				retail markup.
Sale Price
. The price at which
				something sells or is sold after its price has been reduced.
Seating Systems
. A seated positioning
				system, including its components, accessories and modifications, which may be
				attached to a base wheelchair and is designed to meet the individualized
				medical needs of the patient.
Shelf Price
. The sign or tag placed by
				an authorized person at each point of display which clearly sets forth the
				retail price of the item.
Standard Markup
. Except where
				otherwise indicated in an applicable section of
				101 CMR
				322.03, the standard markup for durable
				medical equipment, medical and surgical supplies, and oxygen and respiratory
				equipment that is applied to the AAC, net of any discounts as specified in the
				definition of AAC at 101 CME 322.02, and paid to a supplier by an eligible
				provider cannot exceed:
(a) the
			 applicable standard markup set forth below for items for which the eligible
			 provider received a timely payment discount less than or equal to 5% will be
			 applied to the AAC, net of costs and discounts to be excluded under the
			 definition of AAC at 101 CMR 322.02:
1. 20%
			 for medical and surgical supplies and disposable items;
2. 25% for enteral and parenteral
			 solutions;
3. 35% for wheeled
			 mobility system equipment and accessories, as defined in 101 CMR 322.02, and
			 for certain patient lift systems; and
4. 30% for all other equipment, customized
			 tracheostomy supplies, and certain diabetic equipment and
			 supplies.