Code of Massachusetts Regulations › 130 CMR - DIVISION OF MEDICAL ASSISTANCE › Title 130 CMR 409.000 - Durable Medical Equipment Services › Section 409.402 - Definitions

Current through Register 1525, July 5, 2024
The following terms used in
				130 CMR 409.000 have the
				meanings given in 130 CMR 409.402, unless the context clearly requires a
				different meaning. Payment for services defined in 130 CMR 409.402 is not
				determined by these definitions, but by application of regulations elsewhere in
				130 CMR 409.000,
				101 CMR 322.00:
Durable Medical Equipment, Oxygen and Respiratory Therapy
				Equipment
, and in
				130 CMR 450.000:
Administrative and Billing Regulations
.
Absorbent Products
- diapers or
				brief-like garments, underpads, liners, and shields used to contain and/or
				manage symptoms of incontinence. Absorbent products may be disposable,
				reusable, or washable.
Accessories
- products that are used
				primarily and customarily to modify or enhance the usefulness or functional
				capability of an item of durable medical equipment and that are generally not
				useful in the absence of the item of durable medical equipment.
Accrediting Body
- an organization
				acceptable to the Centers for Medicare & Medicaid Services (CMS) that
				accredits DME providers.
Agent
- the person who has been
				delegated by the applicant or DME provider with the authority to obligate or
				act on behalf of a DME provider or applicant.
Ambulatory Equipment
- DME that
				provide stability and security for members with impaired ambulation.
Applicant
- an organization or
				individual who completes and submits an application to become a provider for
				MassHealth, but has not yet been determined by the MassHealth agency to be
				eligible to become a provider.
Assistive Technology Professional
				(ATP)
- an individual with experience with assistive/
				rehabilitation technology who analyzes the equipment needs of persons with
				disabilities, assists in the selection of DME, and trains the person with the
				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.
Augmentative and Alternative Communication Devices
				(AAC)
- DME that are speech and communication aids that meet the
				functional speaking needs of members for whom such devices are medically
				necessary, with the exception of devices covered pursuant to
				130 CMR
				409.428(E).
Centers for Medicare & 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).
Clinical Nurse Specialist
- a nurse
				who is in good standing with, and meets the requirements of, the Massachusetts
				Board of Registration of Nursing for Clinical Nurse Specialists, and all
				applicable federal and state requirements.
Compression Devices
- products that
				are used for the treatment of lymphedema or chronic venous insufficiency with
				the goal of preventing the onset or worsening of venous stasis ulcers.
Consignment Closet
- an arrangement in
				which a DME Provider maintains inventory at an ordering practitioners' location
				which is not the DME provider's service facility, for delivery to members on
				behalf of the DME Provider.
Criminal Offender Record Information
				(CORI)
- information regulated by the Criminal History Systems
				Board (CHSB) and defined under
				803 CMR
				2.03:
Definitions
to include
				records and data in any communicable form compiled by a criminal justice agency
				that concern an identifiable individual and relate to the nature or disposition
				of a criminal charge, an arrest, a pre-trial proceeding, other judicial
				proceedings, sentencing, incarceration, rehabilitation, or release.
Customized Equipment
- durable medical
				equipment that
(1) is uniquely
			 constructed, adapted, or modified solely for the full time use of the member
			 for whom the item is purchased;
(2)
			 is made to order or adapted to meet the specific needs of the member;
			 and
(3) is uniquely constructed,
			 adapted, or modified to permanently preclude the use of such equipment by
			 another individual.
Date of Service
- the date the DME is
				delivered to or picked up by the member, with the exception of delivery of DME
				to a member in a hospital, nursing facility, or ICF/IID pursuant to
				130 CMR
				409.415(A)(1)(b), (C), (C)(1)(c)
				 and
				130 CMR
				409.419(C)  or, with prior
				authorization, services provided in excess of the otherwise applicable service
				limit pursuant to
				130 CMR
				409.418(F).
Department of Public Health
- an
				agency of the Commonwealth of Massachusetts, established under M.G.L. c. 17,
				§ 1.
DME
- as used in
				130 CMR 409.000, DME means
				the durable medical equipment and medical supplies covered by
				130 CMR 409.000.
DME and Oxygen Payment and Coverage Guideline
				Tool
- a MassHealth web-based application that contains DME and
				oxygen service descriptions for all covered products and 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 EOHHS and the Center for Health
				Information and Analysis (CHIA) websites. Subchapter 6 of the
Durable
				Medical Equipment Manual
directs providers to the MassHealth website
				for the DME and Oxygen Payment and Coverage Guideline Tool.
DME 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 409.404, and
				130 CMR
				450.000:
Administrative and Billing
				Regulations
. DME providers may include providers also enrolled as
				MassHealth participating oxygen and respiratory therapy equipment and supplies
				(OXY) providers, orthotic services providers, or prosthetic services providers
				who meet all program-specific requirements; and MassHealth pharmacy providers
				eligible to enroll with a DME specialty under
				130
				CMR 409.404(C), who also
				meet all applicable requirements of
				130 CMR
				409.000.
Durable Medical Equipment (DME)
-
				equipment that
(1) is used primarily
			 and customarily to serve a medical purpose;
(2) is generally not useful in the absence of
			 disability, illness or injury;
(3)
			 can withstand repeated use over an extended period; and
(4) is appropriate for use in any setting in
			 which normal life activities take place, other than a hospital, nursing
			 facility, ICF/IID, or any setting in which payment is or could be made under
			 Medicaid inpatient services that includes room and board, except as allowed
			 pursuant to
			 130
			 CMR 409.415 and
			 130
			 CMR 409.419(C).
Durable Medical Equipment Manual
-
				provides DME regulations and other guidance issued by the MassHealth agency or
				its designee.
Enteral Nutrition
- nutrition
				requirements that are provided
via
the gastrointestinal cavity
				by mouth (orally) or through a tube or stoma that delivers the nutrients distal
				to the oral cavity.
EOHHS
- the Executive Office of Health
				and Human Services, established under M.G.L. c. 6A.
Federal DME Face-to-face Requirements
- CMS requirements promulgated in
				42 CFR
				440.70 which include the following
				requirements for payment for specific items of DME:
(1) An in-person, face-to-face examination
			 with a Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), or
			 non-physician practitioner: physician assistant (PA), nurse practitioner (NP),
			 or clinical nurse specialist (CNS);
(2) Documentation from the practitioner or
			 non-physician practitioner performing the face-to-face examination that the
			 individual was evaluated and/or treated for a condition that supports the need
			 for the item(s) of DME ordered; and
(3) Occurrence of the face-to-face
			 examination during the six months prior to the start of services.
Food and Drug Administration (FDA)
-
				an agency of the United States Department of Health and Human Services that is
				responsible for the safety regulation of most types of foods, drugs, medical
				devices, and certain other products.
Healthcare Common Procedure Coding System
				(HCPCS)
- for purposes of
				130 CMR
				409.000, HCPCS refers to the Level II HCPCS codes
				which are maintained by CMS, and used by providers to bill for certain medical
				services, devices, and supplies, including all DME services.
Home
- unless otherwise specified for
				purposes of rental and purchase of DME, 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 or 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 409.415.
Home Infusion Therapy (HIT) Services
-
				the administration of medications to a member 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 immune globulin.
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, or an out-of-state hospital
				facility enrolled as a provider in the MassHealth Acute Hospital or Chronic
				Disease and Rehabilitation Inpatient Hospital programs that provide diagnosis
				and treatment on an inpatient or outpatient basis for patients who have any of
				a variety of medical conditions.
Intermediate Care Facilities 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.
Marketing
- any communication from a
				DME provider, or its agent, to a member, or his or her family or caregivers,
				that can reasonably be interpreted as intended to influence the member's choice
				of DME provider, whether by inducing that member
(1) to retain that DME provider to provide
			 DME services to the member;
(2) not
			 to retain DME services from another DME provider; or
(3) to cease receiving DME services from
			 another DME provider.
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 provider and pay for medical services to eligible
				members.
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
(1) required to address an individual's
			 medical disability, illness, or injury;
(2) generally not useful in the absence of
			 illness or injury;
(3) consumable
			 or disposable;
(4) not able to
			 withstand repeated use by more than one individual; and
(5) appropriate for use in any setting in
			 which normal life activities take place, other than a hospital, nursing
			 facility, ICF/IID, or any setting in which payment is or could be made under
			 Medicaid inpatient services that includes room and board.
Medicare Competitive Bid Provider
-
				Medicare-qualified provider chosen to provide Medicare-designated durable
				medical equipment and supplies in specified geographic areas for
				Medicare-specified time periods to MassHealth members with both Medicare and
				Medicaid coverage pursuant to
				42 U.S.C. §
										1395w-3.
Member
- a person determined by the
				MassHealth agency to be eligible for MassHealth.
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.
Non-physician Practitioner
- a nurse
				practitioner or clinical nurse specialist working in collaboration with a
				physician or a physician assistant working under the supervision of a
				physician, who orders DME and writes the prescription for DME in accordance
				with 130 CMR 409.416.
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).
Nursing Facility (NF)
- an institution
				(or a distinct part of an institution) which 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 meet the requirements of the
				Social Security Act § 1919(a), (b), (c) and (d) and is licensed under and
				certified by the Massachusetts Department of Public Health.
Nutritional Supplements
- commercially
				prepared products primarily used to treat a diagnosed deficiency in the
				member's diet or nutrition.
Office of Inspector General (OIG)
- a
				Federal agency established by law as an independent and objective oversight
				unit to carry out the mission of preventing fraud and abuse and promoting
				economy, efficiency, and effectiveness of HHS programs and operations, as
				defined by 5 U.S.C. App. 1.
Ordering Practitioner
- a physician or
				a non-physician practitioner who meets the requirements in
				130
				CMR 409.402, who orders DME and writes the
				prescription for DME in accordance with
				130
				CMR 409.416. For the purposes of
				130 CMR
				409.000, podiatrists are not ordering
				practitioners.
Ostomy Supplies
- products used to
				contain diverted urine or fecal contents outside the body for patients who have
				a surgically created opening (stoma).
Parenteral Nutrition
- nutrient
				requirements provided by means of a subcutaneous or intravenous route.
Personal Emergency Response System
				(PERS)
- an electronic device connected to a person's land-line
				telephone. In an emergency, it can be activated either by pushing a small
				button on a pendant or bracelet, pressing the help button on the console unit,
				or by an adaptive switch set-up. When the device is activated, a person from
				the 24-hours-per-day, seven-days-per-week central monitoring station answers
				the call, speaks to the member
via
the console unit, assesses
				the need for help, and takes appropriate action.
Physician
- a medical doctor or doctor
				of osteopathic medicine who is licensed by the Massachusetts Board of
				Registration in Medicine or by the appropriate board of registration in the
				state in which the physician practices.
Physician Assistant
- a mid-level
				medical practitioner who works under the supervision of a licensed physician
				(MD) or osteopathic physician (DO) and who has graduated from an accredited
				physician assistant program and is certified by and in good standing with the
				Massachusetts Board of Physician Assistant Registration.
Prior Authorization (PA) Request
- a
				request submitted by the DME provider, speech and language pathologist, or
				other entity as specified by MassHealth to the MassHealth agency to determine
				medical necessity in accordance with
				130
				CMR 409.417,
				409.418,
				409.428,
				130
				CMR 450.204:
Medical
				Necessity
, and
				130
				CMR 450.303:
Prior
				Authorization
.
Recall
- action taken by the
				manufacturer of any item covered by
				130 CMR
				409.000 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).
RESNA
- the Rehabilitation Engineering
				and Assistive Technology Society of North America, or its successor.
Seating System
- 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 a member.
Service Facility
- a DME business or
				branch of a DME business where MassHealth members can obtain services,
				equipment, and supplies including, but not limited to, repairs, replacements,
				accessories, or returns.
Serviceable Backup Mobility System
- a
				manual wheelchair approved by the MassHealth agency as a backup to a power
				wheelchair as identified in
				130
				CMR 409.413(D)  or a
				MassHealth member's serviceable retired power wheelchair, that can be safely
				used by the MassHealth member when a manual backup or suitable loaner chair
				cannot be provided to meet the member's medical needs pursuant to
				130
				CMR 409.420(G).
Subcontractor
- an individual, agency,
				or organization
(1) to which a
			 MassHealth provider has contracted or delegated some of its management
			 functions or responsibilities of providing medical care or services to members;
			 or
(2) with which a fiscal agent
			 has entered into a contract, agreement, purchase order, or lease (or leases of
			 real property) to obtain space, supplies, equipment, or services provided under
			 the MassHealth agreement.
Support Surfaces
- beds, mattresses,
				or overlays used to reduce or relieve pressure, prevent the worsening of
				pressure ulcers, or promote wound healing.