101 CMR, § 322.02

Current through Register 1536, December 6, 2024

Section 322.02 - General Definitions

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. See101 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 consumer 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 CMR 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.

(b) the applicable standard markup set forth below for items for which the eligible provider received a timely payment discount greater than 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. 25% for medical and surgical supplies and disposable items;

2. 30% for enteral and parenteral solutions;

3. 40% for wheeled mobility system equipment and accessories, as defined in 101 CMR 322.02; and

4. 35% for all other equipment, customized tracheostomy supplies, and certain diabetic equipment and supplies.

Used Equipment. Any item that has been previously purchased or rented, including equipment that was:

(a) used by a patient for a trial period;

(b) used by the supplier as a demonstrator; or

(c) rented by a patient who now wants to buy it.

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.