Latest Review Date: November 2024

Category: Durable Medical Equipment

POLICY:

Group 1 - Mattress overlays and mattresses (E0181, E0182, E0183, E0184, E0185, E0186, E0187, E0188, E0189, E0196-E0199, A4640)

A group 1 mattress overlay or mattress may be considered medically necessary if the individual meets:

• Criterion 1, or
• Criteria 2 or 3 and at least one of criteria 4 to 7

1. Completely immobile – i.e., member cannot make changes in body position without assistance.
2. Limited mobility – i.e., member cannot independently make changes in body position significant enough to alleviate pressure.
3. Any stage pressure ulcer on trunk or pelvis.
4. Impaired nutritional status.
5. Fecal or urinary incontinence.
6. Altered sensory perception.
7. Compromised circulatory status.

Foam overlay or mattress without waterproof covers are considered investigational, as they are not considered durable equipment.

Group 2 - Alternating Pressure and Low Air Loss Mattresses and Overlays  (E0193, E0277, E0371-E0373)

A group 2 support surface is considered medically necessary DME if the individual meets:

• Criteria 1 and 2 and 3, or
• Criterion 4, or
• Criteria 5 and 6 or
• Criterion 7:

1. The individual has multiple stage II (partial thickness skin loss) pressure ulcers located on the trunk or pelvis.
2. The individual has been on a comprehensive ulcer treatment program* for at least the past month, which has included the use of an appropriate group 1 support surface.
3. The individual's ulcers have worsened or remained the same over the past month.
4. The individual has large or multiple stage III (full thickness tissue loss) or stage IV (deep tissue destruction) pressure ulcer(s) on the trunk or pelvis.
5. The individual has had a recent myocutaneous flap or skin graft for a pressure ulcer on the trunk or pelvis (surgery within the past 60 days).
6. 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).
7. Protein calorie malnutrition requiring parenteral or enteral supplements; and the individual is limited in mobility i.e., member cannot independently make changes in body position significant enough to alleviate pressure, usually requiring the assistance of another individual for positional changes and has at least one of the following:

• Fecal or urinary incontinence
• Altered sensory perception
• Compromised circulatory status

* The comprehensive ulcer treatment described in criterion 2 above should generally include:

• Appropriate management of moisture/incontinence;
• Appropriate turning and positioning;
• Appropriate wound care (for stage II, III, or IV ulcer);
• Education of the individual and caregiver on the prevention and/or management of pressure ulcers;
• Nutritional assessment and intervention consistent with the overall plan of care;
• Regular assessment by the nurse, physician, or other licensed healthcare practitioner

When a Group 2 device is used as part of a treatment plan for wound healing, the device may be considered medically necessary until:

1. The ulcer is healed; or
2. If healing does not continue, there is documentation in the medical record to show that:
   • Other aspects of the care plan are being modified to promote healing; or
   • The use of the Group 2 support surface is medically necessary for wound management.

Group 3 – Air-Fluidized Beds (E0194)  

An air-fluidized bed may be considered medically necessary in the treatment of post myocutaneous flap procedures in the bedridden or wheelchair bound patient with severely limited mobility or extensively burned individual when all of the following criteria are met:

1. Recent myocutaneous flap or skin graft for a stage III or IV pressure ulcer or extensive burn on the trunk or pelvis (surgery within the past 30 days); and
2. The plan of care is outlined for transition to Group 2 support system after this time; and
3. A trained adult caregiver is available to assist the patient with activities of daily living, fluid balance, dry skin care, repositioning, recognition and management of altered mental status, dietary needs, prescribed treatments, and management and support of the air fluidized bed system and its problems, such as leakage; and
4. A physician directs the home treatment regimen and reevaluates and recertifies the need for the air-fluidized bed on a monthly basis; and
5. Anticipated surgery date is included with the request, if applicable; and
6. The home environment is able to support the structural needs of the equipment (weight of bed >1,600 pounds) and the electrical system is sufficient to accommodate the anticipated increase in energy consumption even in the event of a power outage.

Initial certification of E0194 is for 8 weeks, continued recertification requires submission of clinical documentation verifying medical necessity.

DESCRIPTION OF PROCEDURE OR SERVICE:

Pressure-reducing support surfaces include mattress overlays, special mattresses that can be separately purchased or whole beds. Pressure-reducing support surfaces are designed for patients with limited or no mobility who are bed confined most or all of the day and therefore prone to developing pressure ulcers over bony prominences.

Pressure reducing support surfaces are a type of durable medical equipment (DME) used for the care of pressure sores, also known as pressure ulcers. Pressure ulcers are lesions caused by unrelieved pressure resulting in damage of underlying tissue. A major distinction between support surfaces is that some are powered by electricity and others are not. They may be categorized into the following three groups:

• Group 1 support surfaces are generally designed to either replace a standard hospital or home mattress or as an overlay placed on top of a standard hospital or home mattress. Products in this category include mattresses, pressure pads and mattress overlays (foam, air, water, or gel).
• Group 2 support surfaces are generally designed to either replace a standard hospital or home mattress or as an overlay placed on top of a standard hospital or home mattress. Products in this category include powered air flotation beds, powered pressure reducing air mattresses, and non-powered advanced pressure reducing mattresses.
• Group 3 support surfaces are complete bed systems, known as air-fluidized beds, which use the circulation of filtered air through silicone beads.

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was performed through November 5, 2024.

Individuals needing pressure reducing support surfaces should have a care plan, which has been established by the individual’s physician or home care provider, is documented in the individual’s medical records, and should generally include the following:

1. Education of the individual and caregiver on the prevention and/or management of pressure ulcers; and
2. Regular assessment by a nurse, physician, or licensed physical therapist; and
3. Appropriate turning and positioning; and
4. Appropriate wound care; and
5. Appropriate management of moisture/incontinence; and
6. Nutritional assessment and intervention consistent with the overall plan of care. 

The support surface provided for the individual should be one in which the individual does not "bottom out". Bottoming out is the finding that an outstretched hand, placed palm up between the undersurface of the mattress overlay or mattress and the individual's bony prominence (coccyx or lateral trochanter), can readily palpate the bony prominence. This bottoming out criterion should be tested with the individual in the supine position with their head flat, in the supine position with their head slightly elevated (no more than 30 degrees), and in the side-lying position.

The National Pressure Ulcer Advisory Panel Pressure Ulcer Stages was recently updated in 2016.  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.

Pressure Ulcer Stages

Deep Tissue Pressure Injury: 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.

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.

Partial-thickness loss of skin 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 and eschar 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, and intact without erythema or fluctuance) on the heel or ischemic limb should not be softened or removed.

KEY WORDS:

Pressure-reducing support surfaces, mattress, mattress overlay, air-fluidized bed, powered pressure- reducing mattress overlay, foam overlay, non-powered pressure-reducing mattresses, pressure ulcer, pressure injury, ToTo® lateral turning system

PRACTICE GUIDELINES AND POSITION STATEMENTS:

National Pressure Ulcer Advisory Panel (NPUAP)

Support surfaces are an important element in pressure ulcer treatment because they provide an environment that enhances perfusion of injured tissue. Support surfaces alone neither prevent nor heal pressure ulcers. They are to be used as part of a total management plan for pressure ulcer prevention and treatment.

Prevention and Treatment of Pressure Ulcers: Support Surfaces – an extract from the Clinical Practice Guideline:

http://www.internationalguideline.com/static/pdfs/02-NPUAP-EPUAP-PPPIA%20Support%20Surfaces%20Extract%20of%20the%20CPG%202017.pdf

Pressure Ulcer Staging:

https://cdn.ymaws.com/npuap.site-ym.com/resource/resmgr/npuap_pressure_injury_stages.pdf

US PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS:

Not applicable.

APPROVED BY GOVERNING BODIES:

Not applicable

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

HCPCS codes:           

REFERENCES:

1. Association for the Advancement of Wound Care (AAWC). Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. Malvern, PA: Association for the Advancement of Wound Care (AAWC); 2010.
2. Colin D, Rochet JM, Ribinik P, et al. What is the best support surface in prevention and treatment, as of 2012, for a patient at risk and/or suffering from pressure ulcer sore? Developing French guidelines for clinical practice. Ann Phys Rehabil Med. 2012;55(7):466-481.
3. ECRI. Air-fluidized beds used for treatment of pressure ulcers in the home environment. Prepared by ECRI for the Agency for Healthcare Research and Quality (AHRQ). Health Technology Assessment No. 6. Rockville, MD: AHRQ; November 7, 2001.
4. Institute for Clinical Systems Improvement (ICSI). Pressure ulcer prevention and treatment protocol. Health care protocol. Bloomington, MN: Institute for Clinical Systems Improvement (ICSI); January 2012.
5. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
6. National Institute for Clinical Excellence (NICE). The prevention and treatment of pressure ulcers. Clinical Guideline No. 29. London, UK: NICE; 2005.
7. National Pressure Ulcer Advisory Panel Pressure Ulcer Stages, http://www.npuap.org/pr2.htm.
8. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel. Pressure ulcer prevention recommendations. In: Prevention and treatment of pressure ulcers: clinical practice guideline.  Washington (DC): National Pressure Ulcer Advisory Panel; 2009. P. 21-50.
9. National Pressure Ulcer Advisory Panel (NPUAP). Practice Guidelines 2014. http://www.internationalguideline.com/static/pdfs/02-NPUAP-EPUAP-PPPIA%20Support%20Surfaces%20Extract%20of%20the%20CPG%202017.pdf
10. Nicosia G, Gliatta AE, Woodbury MG, Houghton PE. The effect of pressure-relieving surfaces on the prevention of heel ulcers in a variety of settings: A meta-analysis. Int Wound J. 2007;4(3):197-207.
11. Nixon J, Nelson E A, Cranny G, et al.; PRESSURE Trial Group. Pressure relieving support surfaces: A randomised evaluation. Health Technol Assess. 2006;10(22):1-180.
12. Wound, Ostomy, and Continence Nurses Society (WOCN). Guideline for prevention and management of pressure ulcers. WOCN Clinical Practice Guideline No. 2. Mount Laurel, NJ: Wound, Ostomy, and Continence Nurses Society (WOCN); June 1, 2010.

POLICY HISTORY:

Medical Policy Group, August 2005

Medical Policy Group, September 2005 (2)

Medical Policy Administration Committee, September 2005

Available for comment September 26-November 9, 2005

Medical Policy Group, August 2006 (1)

Medical Policy Group, March 2007 (1)

Medical Policy Administration Committee, April 2007

Medical Policy Group, July 2007 (1)

Available for comment August 3-September 17, 2007

Medical Policy Group, July 2009 (1)

Medical Policy Group, September 2011(3); Updated Key Points and References

Medical Policy Group, September 2012 (3): Effective September 14, 2012 this policy is no longer scheduled for regular literature reviews and updates.

Medical Policy Group, November 2019 (6): Updates to Description, Key Points, Practice Guidelines, Key Words (pressure ulcer, pressure injury) and References.

Medical Policy Group, December 2020 (6): Updates to Description, Key Points and References. No change to policy intent.

Medical Policy Group, April 2021 (6): Clarified policy statement to include approval timeframe for E0194. No change to policy intent.

Medical Policy Group, December 2021 (6): Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Key Points and References.

Medical Policy Group, September 2022 (6): 2022 Quarterly Coding Update, added new HCPCS code E0183 to the Current Coding section.

Medical Policy Group, October 2022 (6): Updates to Description, Policy statement to include E0183 and verbiage clarification, Key Points and Key Words. No change to policy intent.

Medical Policy Group, November 2023 (6): Updates to Key Points, Benefit Application and References.

Medical Policy Group, November 2024 (6): Updates to Key Points.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the    

    patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and    

   4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent  

      therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.