Hospital Beds and Pressure Reducing Support Surfaces - (0042) Form

Medical Coverage Policy: 0042

The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients.

Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer's particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based.

For example, a customer's benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer's benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document.

Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.

Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment where appropriate and have discretion in making individual coverage determinations. Where coverage for care or services does not depend on specific circumstances, reimbursement will only be provided if a requested service(s) is submitted in accordance with the relevant criteria outlined in the applicable Coverage Policy, including covered diagnosis and/or procedure code(s).

Reimbursement is not allowed for services when billed for conditions or diagnoses that are not covered under this Coverage Policy (see "Coding Information" below). When billing, providers must use the most appropriate codes as of the effective date of the submission. Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.

Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Coverage Policy

Coverage for hospital beds, related accessories, and pressure reducing support surfaces varies across plans. Refer to the customer's benefit plan document for coverage details. If coverage for the specific hospital bed, accessory, or pressure reducing support surface requested is available, the following conditions of coverage apply.

Hospital Beds and Accessories

• A fixed-height hospital bed (HCPCS codes E0250, E0251, E0290, E0291) when ANY of the following indications are met:
• The individual has a medical condition that requires positioning of the body in ways that are not feasible in an ordinary bed. (Elevation of the head/upper body less than 30 degrees does not usually require the use of a hospital bed.)

• In order to alleviate pain, the individual requires positioning of the body in ways not feasible with an ordinary bed.
• The individual requires the head of the bed to be elevated more than 30 degrees most of the time because of congestive heart failure, chronic pulmonary disease, or problems with aspiration. (Pillows or wedges must have been considered and found impractical for reasons other than convenience.)
• The individual requires traction equipment which can be attached only to a hospital bed.

A variable-height bed (HCPCS codes E0255, E0256, E0292, E0293) when criteria are met for a fixed-height bed and the individual requires a bed height other than that of a fixed-height hospital bed to permit transfers to a chair, wheelchair or standing position.

• A semi-electric bed (HCPCS codes E0260, E0261, E0294, E0295) or total electric bed (HCPCS codes E0265, E0266, E0296, E0297) when criteria are met for a fixed-height hospital bed and the individual requires frequent changes in body position, and/or has an immediate need for a change in body position, and is able to operate the controls for adjustment.
• A heavy-duty, extra-wide/bariatric bed (HCPCS codes E0301, E0303), when criteria are met for a fixed-height bed and the individual’s weight is more than 350 pounds but less than 600 pounds.
• An extra-heavy-duty bed (HCPCS codes E0302, E0304), when criteria are met for a fixed-height hospital bed and the individual weighs 600 pounds or more.

Pediatric Hospital Crib/Bed

A pediatric hospital crib/bed (HCPCS codes E0300, E0328, E0329) is considered medically necessary when required by the individual’s condition and is an integral part of, or an accessory to, a medically necessary hospital bed.

The following accessories for hospital beds are considered medically necessary when criteria have been met for a hospital bed, and there is documentation to support the medical necessity of the accessory:

• bed cradles (HCPCS code E0280)
• trapeze equipment (HCPCS codes E0910, E0911, E0912, E0940)

The following beds or accessories are considered safety devices and not medically necessary:

• manual or electric safety bed systems (e.g., KayserBetten Secure Sleep Systems,
• side rails (HCPCS codes E0305, E0310)
• SleepSafe Beds®)
• safety accessories such as enclosures/canopies (HCPCS code E0316) (e.g., Vail® Enclosed Bed Systems, Posey Bed Canopy beds)

The following types of beds are considered not medically necessary and inappropriate for use in the home setting:

• kinetic therapy beds
• oscillating beds
• Stryker frame beds
• institutional type beds (e.g., HCPCS code E0270)
• continuous lateral rotation beds

The following beds and accessories are not primarily medical in nature and/or are specifically excluded under many benefit plans:

• all nonhospital adjustable beds (e.g., Craftmatic® Adjustable Bed, Simmons® Beautyrest® Adjustable Bed, Adjust-A-Sleep Adjustable Bed)
• bed boards (HCPCS codes E0273, E0315)
• bed elevators (e.g., blocks, lifters)
• bed wedges/pillows
• bedrail pads
• bed spectacles
• call switches
• custom bedroom equipment
• mattresses (e.g., inner spring, foam rubber [HCPCS codes E0271, E0272], viscoelastic or memory foam mattresses [e.g., Tempur-Pedic®], adjustable firmness/support mattresses [e.g., Select Comfort])
• overbed tables (HCPCS code E0274), trays, lap boards
• power/manual lounge beds, including electric chair positioning features
• waterbeds

Pressure Reducing Support Surfaces

Pressure reducing support surfaces are considered medically necessary when the following criteria are met:

Medical Coverage Policy: 0042

• A Group 1 pressure reducing support surface (HCPCS codes E0181, E0182, E0183, E0184, E0185, E0186, E0187, E0196, E0197, E0198, E0199, and A4640) is considered medically necessary when the individual has prodromal skin changes consistent with the development of a pressure injury OR cannot independently make changes in body position significant enough to alleviate pressure AND is at risk for developing a pressure injury AND ANY of the following criteria is met:
• fecal or urinary incontinence
• altered sensory perception
• compromised circulatory status
• A Group 2 pressure reducing support surface (HCPCS codes E0193, E0277, E0371, E0372, and E0373) is considered medically necessary when ANY of the following criteria is met:
• Large or multiple Stage 3 or 4 pressure injuries are present on the trunk or pelvis.
• A myocutaneous flap or skin graft has been performed within the past 60 days for a pressure injury on the trunk or pelvis AND the individual has been on a Group 2 or 3 support surface immediately prior to a recent discharge from a hospital or nursing facility (discharge within the past 30 days). Following myocutaneous flap or skin graft, coverage is usually limited to 60 days from the date of surgery.

• Multiple Stage 2 pressure injuries are located on the trunk or pelvis and have not improved over the past month despite the use of an appropriate Group 1 support surface AND a comprehensive wound treatment program that includes:
• education of the individual and caregiver on the prevention and/or management of pressure injuries
• regular assessment by a nurse, physician or other licensed health care practitioner (i.e., usually at least weekly for an individual with a Stage 3 or 4 injury)
• appropriate turning and positioning
• appropriate wound care for a Stage 2, 3 or 4 injury
• appropriate management of moisture/incontinence
• nutritional assessment and intervention consistent with the overall plan of care
• A Group 3 pressure reducing support surface (HCPCS code E0194) is considered medically necessary when ALL of the following criteria are met:
• The individual has a Stage 3 or Stage 4 pressure injury.
• The individual is bedridden or chair-bound as a result of severely limited mobility.
• Without an air-fluidized bed, the individual would require institutionalization.
• The air-fluidized bed is ordered following a comprehensive assessment and evaluation of the individual after at least 30 days indicating that all of the following conservative medical management has been attempted without success:
• education of the individual and caregiver on the prevention and/or management of pressure injuries
• assessment by a physician, nurse or other licensed health care practitioner at least weekly
• appropriate turning and positioning
• use of a Group 2 support surface, if appropriate
• appropriate wound care
• appropriate management of moisture/incontinence
• nutritional assessment and intervention consistent with the overall plan of care
• None of the following contraindications to the use of an air-fluidized bed pertain:
• There is severe coexisting pulmonary disease (lack of firm back support makes coughing ineffective, and dry air inhalation thickens pulmonary secretions).
• Treatment is required that utilizes wet soaks or moist dressings that are not protected by an impervious covering, such as plastic wrap or other occlusive material.
• The caregiver is unwilling or unable to provide the type of care required for an individual on an air-fluidized bed.
• The structural support is inadequate to sustain the weight of an air-fluidized system, which generally weighs at least 1600 pounds.
• The existing electrical system cannot adequately support the anticipated increase in energy consumption.

The use of a pressure reducing support surface for any other indication is not covered or reimbursable.

General Background

Hospital Beds and Related Accessories

A hospital bed is one that has manual head and leg elevation adjustment capabilities. Hospital beds can be categorized as follows:

• Fixed-height hospital beds allow manual adjustments to head and leg elevation but not to height.
• Variable-height hospital beds allow manual adjustments to height, as well as to head and leg elevation.
• Semi-electric beds allow manual adjustments to height and electric adjustments to head and leg elevation.
• Totally electric beds allow electric adjustment to height, as well as to head and leg elevation.

Bed Types

A fixed-height hospital bed (HCPCS codes E0250, E0251, E0290 or E0291) may be appropriate for any of the conditions below:

• The patient has a medical condition that requires positioning of the body in ways that are not possible in an ordinary bed.
• Elevating the head/upper body less than 30 degrees does not usually require the use of a hospital bed.
• In order to alleviate pain, the patient requires positioning of the body in ways not possible with an ordinary bed.

Examples include:

• an older child with seizures to allow a caregiver access from any angle for the child’s safety to prevent aspiration and hospital admission
• an older child with autism or behavioral issues who needs to be restrained at night to prevent them from leaving the home or injuring themselves or others

Accessories

A trapeze bar (HCPCS codes E0910, E0911, E0912, or E0940) may be appropriate if the patient requires the device to do any of the following:

• get in and out of bed
• sit up because of a respiratory or other medical condition
• change body position because of a medical condition

Trapeze equipment is not considered medically necessary for use with ordinary beds.

When it is medically necessary for the patient to avoid contact with the bed coverings, a bed cradle (HCPCS code E0280) may be needed. Examples of medical conditions that may require decreased contact with bed coverings are: acute gouty arthritis, diabetic foot ulcers, pressure injuries, and burns.

Side rails (HCPCS codes E0305, E0310) are items intended for the prevention of injury and may or may not be an integral part of a hospital bed. Side rails that are not an integral part of a hospital bed are considered safety devices and are not medically necessary.

Other Bed Types and Accessories

Some institutional-type and specialty beds deliver therapies that are known as "kinetic therapy" and "continuous lateral rotational therapy" which means the bed turns continuously and slowly. These types of beds are used to help drain lung secretions and to relieve pressure. They are often used for patients with spinal cord injuries or impaired respiratory function in an acute care hospital setting.

Lateral rotational therapy beds like The Freedom Bed™ (ProBed Medical Technologies Inc., British Columbia, Canada) have been proposed for facility or home use. The Freedom Bed has a platform made up of three hinged longitudinal sections. The bed rotates so that the outer section of the platform turns up to form a "wing", turning the patient up to 30 degrees; the process then reverses to turn the patient to the other side. The frequency, duration, and degree of rotation may be adjusted by facility staff, a caregiver, or the patient.

Continuous lateral rotation has been proposed for the prevention and management of pressure injuries, but ideal technical parameters (e.g., bed tilt angle, rotation frequency) have yet to be defined (Berlowitz, 2022). Many clinical studies have been conducted to research the clinical benefits of various degrees of rotation, but all of these studies have been conducted in hospitals, and primarily in critical care units (Schieren, et al., 2020; Bein, et al., 2012; Goldhill, et al., 2007; Delaney, et al., 2006).

There is a lack of published comparative controlled trials evaluating the safety and efficacy of lateral rotational therapy for use in the home.

The use of institutional beds, kinetic therapy beds, Stryker frame beds, oscillating beds or other, similar beds in the home care setting is considered inappropriate.

Manual/electric safety bed systems such as the KayserBetten Secure Sleep Systems (KayserBetten-U.S., Allentown, PA, US) or SleepSafe Beds® (SleepSafe Beds, LLC., Bassett, VA, USA) are considered safety devices and not medically necessary.

Safety enclosure canopies (e.g., Vail enclosures, Posey bed enclosures/canopy systems [HCPCS code E0316]) are a frame or canopy used to prevent a patient from leaving the bed. This item encloses the standard hospital bed with a netting attached to a frame and is designed for patients who would need to be restrained. The intended purpose was to restrain a patient without the need for leg or wrist restraints.

Safety enclosures/canopies are not primarily medical in nature and are considered not medically necessary. The following accessories are not considered primarily medical in nature, are not primarily used in the treatment of disease or injury, and are considered not medically necessary:

• mattresses (e.g., innerspring, foam rubber)
• power/manual lounge beds
• nonhospital adjustable beds
• overbed tables (HCPCS code E0274), trays, lap boards
• bed rail pads
• bed elevators (e.g., blocks, lifters)
• bed boards (HCPCS codes E0273, E0315)
• bed spectacles
• waterbeds
• bed wedges/pillows
• custom bedroom equipment
• call switches

U.S. Food and Drug Administration (FDA)

There are many hospital and therapeutic beds, pediatric medical cribs, and bed accessories which have been cleared through the FDA 510(k) premarket notification process. Most powered hospital beds are Class II devices, while manual and hydraulic beds are often exempted Class I devices. Examples of cleared devices may be found in the FDA 510(k) premarket notification database, under product codes FMS (pediatric medical crib); LLI (AC-powered adjustable hospital bed); FNJ (manual adjustable hospital bed); and FNK (hydraulic adjustable hospital bed).

The FDA page on Hospital Beds notes that between January 1, 1985 and January 1, 2013, the FDA received 901 incidents of patients caught, trapped, entangled, or strangled in hospital beds. The reports included 531 deaths, 151 nonfatal injuries, and 220 cases where staff needed to intervene to prevent injuries.

The FDA and the Hospital Bed Safety Workgroup released the \'Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment\' document on March 10, 2006. This guidance provides recommendations for manufacturers of new hospital beds and for facilities with existing beds, to help improve the safety of patients in hospitals, nursing homes, and private homes.

Effective January 2017, the FDA issued a final rule to rename pediatric hospital beds \

The cornerstone of therapy involves the use of appropriate wound dressings, pressure-reducing devices, treatment of infection, debridement, and surgical consultation when appropriate (Welesko and Javier, 2023; Wester, 2023). Initial treatment for pressure injuries is to relieve pressure by positioning the patient frequently and at a fixed interval to relieve pressure over the compromised area. A number of medical devices are designed to relieve pressure. The choice of devices should be based on durability, ease of use, and patient comfort. These devices can be classified as static or dynamic.

Static devices include air-, gel-, or water-filled containers that reduce the tissue–surface interface. Dynamic devices use a power source to inflate compartments that support the patient’s weight or alternate the pressure on different areas of the body. A static device is recommended when the patient has good bed mobility. A dynamic device is recommended when the patient cannot self-position in bed. A check for bottoming out is generally done for all devices. To check for bottoming out, the hand is inserted palm upward under the patient’s sacrum between the device and the bed surface. It is recommended that if no air column is apparent between the patient and the bed surface, the device is ineffective and should be changed.

Also, it is suggested that patients who fail to improve, or who have multiple pressure injuries, should be considered for a dynamic-type device, such as a low-air-loss bed or air-fluidized bed (Welesko and Javier, 2023; Wester, 2023).

Staging of Pressure Injuries

When evaluating pressure injuries, a staging system is typically used that measures tissue destruction by classifying wounds according to the tissue layers involved. In 2016, the National Pressure Injury Advisory Panel (NPIAP) renamed the term pressure ulcer with pressure injury and redefined the definition of a pressure ulcer and the stages of pressure injury including the original four stages and updating two stages on deep tissue injury and unstageable pressure injury. In addition to the change in terminology, Arabic numbers replace Roman numerals to identify the stages. Two additional pressure injury definitions: Medical device and Mucosal Membrane Pressure Injury were added. The updated staging system includes the following definitions:

• Pressure Injury: A pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities and condition of the soft tissue.
• Stage 1 Pressure Injury – Non-blanchable erythema of intact skin: Intact skin with a localized area of non-blanchable erythema, which may appear differently in darkly pigmented skin. Presence of blanchable erythema or changes in sensation, temperature, or firmness may precede visual changes. Color changes do not include purple or maroon discoloration; these may indicate deep tissue pressure injury.
• Stage 2 Pressure Injury – Partial-thickness skin loss with exposed dermis: The wound bed is viable, pink or red, moist, and may also present as an intact or ruptured serum-filled blister. Adipose (fat) is not visible and deeper tissues are not visible. Granulation tissue, slough, eschar, and Medical Coverage Policy: 0042 are not present. These injuries commonly result from adverse microclimate and shear in the skin over the pelvis and shear in the heel.

This stage should not be used to describe moisture associated skin damage (MASD) including incontinence associated dermatitis (IAD), intertriginous dermatitis (ITD), medical adhesive related skin injury (MARSI), or traumatic wounds (skin tears, burns, abrasions).

• Stage 3 Pressure Injury – Full-thickness skin loss: Full-thickness loss of skin, in which adipose (fat) is visible in the ulcer, and granulation tissue and epibole (rolled wound edges) are often present. Slough and/or eschar may be visible. The depth of tissue damage varies by anatomical location; areas of significant adiposity can develop deep wounds. Undermining and tunneling may occur. Fascia, muscle, tendon, ligament, cartilage and/or bone are not exposed. If slough or eschar obscures the extent of tissue loss this is an Unstageable Pressure Injury.
• Stage 4 Pressure Injury – Full-thickness skin and tissue loss: Full-thickness skin and tissue loss with exposed or directly palpable fascia, muscle, tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar may be visible. Epibole (rolled edges), undermining and/or tunneling often occur. Depth varies by anatomical location. If slough or eschar obscures the extent of tissue loss, this is an Unstageable Pressure Injury.
• Unstageable Pressure Injury – Obscured full-thickness skin and tissue loss: Full-thickness skin and tissue loss in which the extent of tissue damage within the ulcer cannot be confirmed because it is obscured by slough or eschar. If slough or eschar is removed, a Stage 3 or Stage 4 pressure injury will be revealed. Stable eschar (i.e., dry, adherent, intact without erythema or fluctuance) on the heel or ischemic limb should not be softened or removed.
• Deep Tissue Pressure Injury (DPTI) – Persistent non-blanchable deep red, maroon or purple discoloration: Intact or non-intact skin with localized area of persistent non-blanchable deep red, maroon, purple discoloration or epidermal separation revealing a dark wound bed or blood filled blister. Pain and temperature change often precede skin color changes. Discoloration may appear differently in darkly pigmented skin. This injury results from intense and/or prolonged pressure and shear forces at the bone-muscle interface. The wound may evolve rapidly to reveal the actual extent of tissue injury, or may resolve without tissue loss. If necrotic tissue, subcutaneous tissue, granulation tissue, fascia, muscle or other underlying structures are visible, this indicates a full thickness pressure injury (Unstageable, Stage 3 or Stage 4). Do not use DTPI to describe vascular, traumatic, neuropathic, or dermatologic conditions.

Additional pressure injury and equipment definitions include:

• Medical Device Related Pressure Injury: This describes an etiology (cause of the injury). Medical device related pressure injuries result from the use of devices designed and applied for diagnostic or therapeutic purposes. The resultant pressure injury generally conforms to the pattern or shape of the device. The injury should be staged using the staging system.
• Mucosal Membrane Pressure Injury: Mucosal membrane pressure injury is found on mucous membranes with a history of a medical device in use at the location of the injury. Due to the anatomy of the tissue these injuries cannot be staged.

Support Surfaces

Group 1 Pressure Reducing Support Surfaces: These include HCPCS codes that stand for static overlays and mattress replacements:

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• Pressure Pads for Mattresses: Code E0185 and codes E0197-E0199, termed \

  Nonpowered Pressure Reducing Mattresses

  • An air, water or gel mattress (HCPCS codes E0186, E0187, E0196) has the following characteristics:
    • height of five or more inches of the air, water or gel layer
    • durable, waterproof cover
    • can be placed directly on a hospital bed frame
  • A foam mattress (E0184) has the following characteristics:
    • height of five or more inches
    • foam of such density and other qualities that it provides adequate pressure reduction
    • durable waterproof cover
    • can be directly placed on a hospital bed frame

  Powered Pressure Reducing Mattress Overlay Systems

  Codes E0181, E0182, and A4640 represent powered pressure reducing mattress overlay systems (alternating pressure or low air loss) that have the following characteristics:

  • An air pump or blower provides both sequential inflation and deflation of air cells, or low interface pressure throughout the overlay.
  • The inflated cell height of the air cells through which air circulates is two and one-half inches or more.
  • The height of the air chambers, proximity of the air chambers to one another, frequency of air cycling (for alternating pressure overlays), and air pressure provide adequate patient lift, reduce pressure and prevent bottoming out.

  Group 2 Pressure Reducing Support Surfaces

  These include HCPCS codes that are defined as follows:

  • Powered Pressure Reducing Mattress: Code E0277 stands for a powered pressure reducing mattress (alternating pressure, low air loss, or powered flotation without low air loss) that has the following characteristics:
    • An air pump or blower provides both sequential inflation and deflation of the air cells, or low interface pressure throughout the mattress.
    • The inflated cell height of the air cells though which air circulates is five inches or more.
    • The height of the air chambers, proximity of the air chambers to one another, frequency of air cycling (for alternating pressure mattresses), and air pressure provide adequate patient lift, reduce pressure and prevent bottoming out.
    • The surface is designed to reduce friction and shear.
    • The surface can be placed directly on a hospital bed frame.
    • Code E0277 includes lateral rotation, which is a method of pressure management with support surfaces that can be programmed to rotate the patient up to 40° in either direction from flat supine. Lateral rotation (e.g., adjutant therapy, rotation therapy) was developed to attempt to prevent respiratory complications in the intensive care patient, or patient on extended bed-rest. Since its introduction into the market, lateral rotation has been used for the management of skin breakdown.
    • Indications for this method of pressure management include prevention or healing of pressure injuries in patients at high risk due to their inability to change positions.
    • Continuous lateral rotation therapy utilizes mattresses and beds that move the patient in a regular pattern around a longitudinal axis.

  Examples of continuous lateral rotation mattresses include, but are not limited to:

  • Invacare microAIR Lateral Rotation Mattress (Invacare, Elyria, OH)
  • PressureGuard® APM2 (Span America, Greenville, SC)

  Code E0193 describes a semi-electric or total electric hospital bed with a fully integrated powered pressure reducing mattress which has all the characteristics defined above.

  Advanced Nonpowered Pressure Reducing Mattress Overlay:

  Code E0371 describes an advanced, nonpowered pressure reducing mattress overlay with the following characteristics:

  • The height and design of individual cells provide significantly more pressure reduction than in a Group 1 overlay and prevent bottoming out.
  • The total height is three inches or more.
  • The surface is designed to reduce friction and shear.
  • There is documented evidence to substantiate that the product is effective in treating conditions described by the coverage criteria for Group 2 support surfaces.

  Powered Pressure Reducing Mattress Overlay:

  Code E0372 describes a powered pressure reducing mattress overlay (low air loss, powered flotation without low air loss, or alternating pressure) with the following characteristics:

  • An air pump or blower provides both sequential inflation and deflation of the air cells, or low interface pressure throughout the overlay. The inflated cell height of the air cells through which air circulates is 3.5 inches or more.
  • The height of the air chambers, proximity of the air chambers to one another, frequency of air cycling (for alternating pressure overlays), and air pressure provide adequate patient lift, reduce pressure and prevent bottoming out.
  • The surface is designed to reduce friction and shear.

  Advanced Nonpowered Pressure Reducing Mattress:

  Code E0373 describes an advanced, manually powered pressure reducing mattress with the following characteristics:

  • The height and design of individual cells provide significantly more pressure reduction than those in a Group 1 mattress and prevent bottoming out.
  • The total height is five inches or more.
  • The surface is designed to reduce friction and shear.
  • There is documented evidence to substantiate that the product is effective in treating conditions described by the coverage criteria for Group 2 support surfaces.
  • The mattress can be placed directly on a hospital bed frame.

  Group 3 Pressure Reducing Support Surfaces

  Group 3 Pressure Reducing Support Surfaces are described by a single HCPCS code, defined as follows:

  Air-Fluidized Bed:

  Code E0194 describes an air-fluidized bed, a device with ALL of the following characteristics:

  • The bed employs circulation of filtered air through silicone-coated ceramic beads, creating the characteristics of fluid.
  • The bed consists of a tank filled with silicone-coated microsphere beads that resemble grains of sand.
  • The tank is covered with a loose-fitting filter sheet that separates the patient from the beads.
  • Room air is drawn into the base unit, then filtered, heated and pushed into the tank through a diffuser board.
  • The airflow suspends the beads, causing them to take on properties of a fluid.
  • The sheet moves freely above the patient through the fluid. Usually, the patient sinks only 4–6 inches into the beads, and the pressure put on the skin is well below capillary closing pressure.
  • The sheet is permeable to the downward flow of body fluids (e.g., wound drainage, urine, or perspiration). As body fluids come in contact with the beads, the beads clump and drop to the bottom of the tank, where the alkaline environment kills the bacteria. The clumps are removed during routine maintenance.
  • Patient transfers in and out of bed may be difficult and, in most models, the head cannot be elevated.
  • When the airflow is turned off, the beads settle into a mold around the body, creating a support surface that stabilizes the patient for nursing care, wound cleaning and other care needs.

  U.S. Food and Drug Administration (FDA)

  The FDA has cleared numerous types of support surfaces via the 510(k) premarket notification process. Most support surfaces are classified as Class II or exempted Class I devices. Examples of cleared devices may be found in the FDA 510(k) premarket notification database, under product codes FNM (alternating pressure air flotation mattresses); IKY (nonpowered flotation therapy mattresses); and INX (air-fluidized beds).

  Literature Review

  Shi et al. (2021e) conducted a meta-analysis to summarize evidence from Cochrane Reviews that assess the effects of beds, overlays and mattresses on reducing the incidence of pressure ulcers and on increasing pressure ulcer healing in any setting and population; to assess the relative effects of different types of beds, overlays and mattresses for reducing the incidence of pressure ulcers and increasing pressure ulcer healing in any setting and population; and to cumulatively rank the different treatment options of beds, overlays and mattresses in order of their effectiveness in pressure ulcer prevention and treatment.

  The review included six Cochrane Reviews, all at low or unclear risk of bias. Pressure ulcer prevention: four reviews (68 studies/18,174 participants) reported direct evidence for 27 pairwise comparisons between 12 types of support surfaces on the following outcomes: pressure ulcer incidence, time to pressure ulcer incidence, patient comfort response, adverse event rates, health-related quality of life, and cost-effectiveness.

  There was low-certainty evidence that more people with pressure ulcers may heal completely using reactive air surfaces than using foam surfaces. The authors noted they were uncertain which surfaces have the highest probability of being the most effective (all very low- certainty evidence).

  Regarding time to complete pressure ulcer healing: this overview included direct evidence for one comparison – people using reactive air surfaces may be more likely to have healed pressure ulcers compared with those using foam surfaces in long-term care settings (low-certainty evidence).

  The authors concluded that compared with foam surfaces, reactive air surfaces may reduce pressure ulcer risk and may increase complete ulcer healing; compared with foam surfaces, alternating pressure air surfaces may reduce pressure ulcer risk and are probably more cost-effective in preventing pressure ulcers; compared with foam surfaces, reactive gel surfaces may reduce pressure ulcer risk, particularly for people in operating rooms and long-term care settings.

  It was noted that there are uncertainties for the relative effectiveness of other support surfaces for preventing and treating pressure ulcers, and their efficacy ranking and more high-quality research is required (e.g., for the comparison of reactive air surfaces with alternating pressure air surfaces). The authors noted future studies should consider time-to-event outcomes and be designed to minimize any risk of bias.

  An updated Cochrane review by McInnes et al. (2018) assessed the effectiveness of support services for the treatment of pressure ulcers. A total of 19 trials involving 3241 participants met the inclusion criteria. Most trials were small, with sample sizes ranging from 20 to 1971, and were generally at high or unclear risk of bias. The authors summarized that overall the evidence was of low to very low certainty and was primarily downgraded due to risk of bias and imprecision with some indirectness.