Pressure Reducing Support Surfaces

Number: 0430

Policy

Aetna considers pressure-relieving support surfaces medically necessary as durable medical equipment (DME) according to the selection criteria set forth below.

1. Group 1 Support Surfaces:

   A group 1 mattress overlay or mattress is considered medically necessary DME if the member meets:

   1. Criterion 1, or
   2. Criteria 2 or 3 and at least one of criteria 4 to 7
      1. Completely immobile -- i.e., member can not make changes in body position without assistance.
      2. Limited mobility -- i.e., member can not 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.

   A group 1 support surface is considered experimental and investigational when these criteria are not met because of insufficient evidence in the peer-reviewed literature.

2. Group 2 Pressure Reducing Support Surfaces:

   Alternating Pressure and Low Air Loss Mattresses and Overlays

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

   1. Criteria 1 and 2 and 3, or
   2. Criterion 4, or
   3. Criteria 5 and 6.
      1. The member has multiple stage II (partial thickness skin loss) pressure ulcers located on the trunk or pelvis.
      2. The member 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 member's ulcers have worsened or remained the same over the past month.
      4. The member 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 member 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 member 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).

   ^† 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 member 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 (usually at least weekly for a member with a stage III or stage IV ulcer).

   If the member is on a group 2 surface, there should be a care plan established by the physician or home care nurse, which includes the above elements.

   When a group 2 support surface is prescribed for a myocutaneous flap or skin graft, continued use is generally considered medically necessary for up to 60 days from the date of surgery.

   Use of a group 2 support surface is considered medically necessary until the ulcer is healed or, if healing does not continue, there is documentation in the medical record to show:

   1. other aspects of the care plan are being modified to promote healing, or
   2. the use of the alternating pressure mattress is medically necessary for wound management. 

   A group 2 support surface is considered experimental and investigational when these criteria are not met because of insufficient evidence in the peer-reviewed literature.

3. Group 3 Pressure Reducing Support Surfaces:

   Air-Fluidized Beds (Bead Beds)

   An air-fluidized bed is considered medically necessary DME only if all of the following criteria are met:

   1. The member has a stage III (full thickness tissue loss) or stage IV (deep tissue destruction) pressure ulcer.
      
      
      1. A stage III or stage IV pressure ulcer of the foot does not require an air-fluidized bed because the foot can be elevated to relieve pressure.
      2. If the member is on an air-fluidized bed and an ulcer is less than 8 square centimeters and/or it is in an area other than the posterior trunk or pelvis, the attending physician must document why an alternative support surface would not be medically effective.
         
         
   2. The member is bedridden or chair bound as a result of severely limited mobility.
   3. In the absence of an air-fluidized bed, the member would require institutionalization (i.e., hospitalization or placement in a nursing home).
   4. The air-fluidized bed is ordered in writing by the member's attending physician based upon a comprehensive assessment and evaluation of the member after conservative treatment^† has been tried without success.

      • The evaluation generally must be performed within a week prior to initiation of therapy with the air-fluidized bed.

   5. A trained adult caregiver is available to assist the member 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.
   6. A physician directs the home treatment regimen, and reevaluates and recertifies the need for the air-fluidized bed on a monthly basis;
   7. All other alternative equipments have been considered and ruled out.

      ^† The conservative treatment program should generally include:

      1. Appropriate management of moisture/incontinence,
      2. Appropriate turning and positioning,
      3. Appropriate wound care,
      4. Assessment by a physician, nurse, or other licensed healthcare practitioner at least weekly,
      5. Education of the member and caregiver on the prevention and/or management of pressure ulcers,
      6. Nutritional assessment and intervention consistent with the overall plan of care,
      7. Use of a group 2 support surface, if appropriate.
         
         
   The member must generally have been on the conservative treatment program for at least 1 month prior to use of the air-fluidized bed with worsening or no improvement of the ulcer.  Continued use of an air-fluidized bed is considered medically necessary until the ulcer is healed, or if healing does not continue, there is documentation in the medical record to show that:
   
   

   1. other aspects of the care plan are being modified to promote healing; or
   2. the use of the bed is medically necessary for wound management.

   Note: Coverage of an air-fluidized bed is limited to the equipment itself.  Architectural adjustments such as electrical or structural improvements for the air-fluidized bed are generally excluded from coverage.  In addition, services of informal caregivers are excluded from coverage.  Please check benefit plan descriptions.
   
   An air-fluidized bed is considered experimental and investigational because of insufficient evidence in the peer-reviewed literature when the afore-mentioned criteria are not met.

   An air-fluidized bed has no proven value for persons with any of the following contraindications: 

   1. Electrical system is insufficient for the anticipated increase in energy consumption;
   2. Structural support is inadequate to support the weight of the air-fluidized bed system (it generally weighs 1,600 pounds or more);
   3. The caregiver is unwilling or unable to provide the type of care required by the patient on an air-fluidized bed;
   4. The member has co-existing pulmonary disease (the lack of firm back support makes coughing ineffective and dry air inhalation thickens pulmonary secretions);
   5. The member requires treatment with wet soaks or moist wound dressings that are not protected with an impervious covering such as plastic wrap or other occlusive material; or
   6. Other known contraindications to use of an air-fluidized bed exist.

   Examples of brands of group 3 support surfaces (air-fluidized beds) include the Clinitron, Fluid Air, and Mediscus Heavy Duty System.

4. Ordinary Air Mattresses:

   Note: Aetna does not cover air mattresses other than alternating air mattresses and low-air-loss beds because they do not meet Aetna's contractual definition of durable medical equipment (i.e., because they are not durable (made to withstand prolonged use), not mainly used in the treatment of disease or injury, and are normally of use to persons who do not have a disease or injury.  Please check benefit plan descriptions for details.  The following are examples of brand names of air mattresses that are not covered:

   1. Air Flow Mat air-filled vibrating mattress
   2. Air-O-Pad air mattress.

5. Sheepskin and Lambswool Pads:

   Medical necessity criteria for sheepskin and lambswool pads are the same as for alternating pressure pads and mattresses (group 2 pressure-reducing support surfaces).

6. Decubitus Care Accessories:

   1. Bed blanket cradle (keeps bed covers from touching affected skin) are considered medically necessary for diabetic ulcers, decubiti or burns, or gouty arthritis.
   2. Heel or elbow protectors are considered medically necessary.

For all types of support surfaces, the support surface provided for the member should be one in which the member does not “bottom out”.  Bottoming out is the finding that an outstretched hand can readily palpate the bony prominence (coccyx or lateral trochanter) when it is placed palm up between the undersurface of the overlay or mattress and in an area under the bony prominence.  This bottoming out criterion should be tested with the member 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 sidelying position.  Support surfaces that do not prevent bottoming out are considered not medically necessary.

Background

Pressure relieving support surfaces are designed to prevent or promote the healing of pressure ulcers by reducing or eliminating tissue interface pressure.  Most of these devices reduce interface pressure by conforming to the contours of the body so that pressure is distributed over a larger surface area rather than concentrated on a more circumscribed location.

The purpose of this clinical policy bulletin (CPB) is to provide guidance on selection of support surfaces.  This assessment provides a comparative evaluation of alternating air mattresses (such as the Pegasus Airwave System), air-fluidized beds (such as the Clinitron bed), and low-air-loss mattresses (such as the Flexicair bed).  This CPB addresses coverage of mattress overlays, specialized mattresses and specialty beds.  Such devices are made entirely of foam, are constructed of an outer membrane that encases a gel, foam, air, water, or polyfill, or are engineered to fluidize ceramic beads.

This clinical policy on pressure-relieving support surfaces is based on Medicare criteria and on the recommendations of the AHCPR Treatment of Pressure Ulcers Guidelines Panel.  Use of low-air-loss beds and air-fluidized beds is reserved for patients with stage III and stage IV ulcers.  Because pressure-reducing support surfaces can be developed and marketed without efficacy studies, few data exist to recommend their rational use.  In the absence of evidence demonstrating differences in efficacy between air-fluidized beds, low-air-loss beds, and alternating air mattresses, it is reasonable to reserve treatment with the most expensive of these 3 types of support surfaces to patients with ulcers that have failed to heal with one of the other types of beds.

The 1994 AHCPR Guidelines on Treatment of Pressure Ulcers provides an algorithm for selection of overlays and mattresses.  Low-air-loss beds and air-fluidized beds are reserved for patients with multiple, large, truncal stage III or IV ulcers and for patients who have bottomed out on a dynamic overlay or mattress.  It is reasonable to first try a low-air-loss bed (such as a Flexair) or a dynamic overlay (such as a Pegasus Airwave) and progress to an air-fluidized bed (such as a Clinitron) if it appears that the patient's ulcer is not healing properly.

No conclusions about the comparative efficacy of the low-air-loss bed, the alternating air mattress, and the air-fluidized bed can be drawn from available evidence because of a lack of studies that compare these support surfaces to each other.  Published studies of support surfaces have compared air-flotation beds or alternating air mattresses to static support surfaces or regular mattresses.  The Treatment of Pressure Ulcers Guidelines Panel found that “[n]o studies have compared the effectiveness of low-air-loss beds and air-fluidized beds.”  The Panel concluded that “[a] randomized controlled trial will be required to compare low-air-loss bed and air-fluidized bed therapy.”

The August 1997 issue of Clinics in Geriatric Medicine was devoted to treatment of pressure ulcers.  Experts on pressure ulcers, including several members of the AHCPR's Treatment of Pressure Ulcers Guidelines Panel, reviewed the medical literature that has appeared since the publication of the AHCPR pressure ulcer guidelines.  Remsberg and Bennett (1997) reviewed the literature on overlays, replacement mattresses, and specialty beds.  The authors concluded:

"Expensive low-air-loss beds and air-fluidized beds have been inadequately studied, and their use is usually driven by reimbursement issues and the experience and biases of nurses and physicians.  Although 2 randomized prospective trials showed that healing rates were statistically superior for these expensive devices, one study did not demonstrate superior healing.  In all of these studies, some patients developed new sores despite treatment on the specialty surfaces.  In addition to statistical superiority, clinical significance must also be evaluated.  For example, in the only randomized trial assessing the efficacy of air-fluidized beds, even the authors noted that the reported outcome differences (0.5 cm2 median increase in surface area in the control group versus 1.2 cm2 median decrease in the treatment group) were hardly clinically impressive.  In a large retrospective descriptive study, the observation was made that many patients who were admitted to a long-stay hospital for treatment of severe pressure sores on air-fluidized beds died within the first 30 days after admission.  Since no discernible pressure sore healing occurred for these patients before they died, the issue of futility must be considered when making treatment decisions for similar patients".

In a Cochrane review, McInnes et al (2011) evaluated the effects of pressure-relieving support surfaces in the treatment of pressure ulcers.  These investigators searched the Cochrane Wounds Group Specialised Register (searched July 15, 2011); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 3); Ovid MEDLINE (2007 to Week 1 of July 2011); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, July 14, 2011); Ovid EMBASE (2007 to Week 27 of 2011); EBSCO CINAHL (2007 to July 14, 2011).  The reference sections of included studies were also searched.  They included published or unpublished randomized controlled trials (RCTs) that assessed the effects of support surfaces for treating pressure ulcers, in any patient group or setting that reported an objective measure of wound healing.  Data extraction and assessment of risk of bias were performed independently by 2 review authors.  Trials with similar patients, comparisons and outcomes were considered for pooled analysis.  Where pooling was inappropriate the results of the trials were reported narratively.  Where possible, the risk ratio or mean difference was calculated for the results of individual studies.  These researchers identified 18 trials of support surfaces for pressure ulcer treatment, involving 1,309 participants with samples sizes that ranged from 14 to 160.  Of 3 trials comparing air-fluidized devices with conventional therapy, 2 reported significant reductions in pressure ulcer size associated with air-fluidized devices.  Due to lack of reported variance data these investigators could not replicate the analyses.  In relation to 3 of the trials that reported significant reductions in pressure ulcer size favoring low air loss devices compared with foam alternatives, they found no significant differences.  A small trial found that sheepskin placed under the legs significantly reduced redness and similarly a small subgroup analysis favored a profiling bed compared with a standard bed in terms of the healing of existing grade 1 pressure ulcers.  Poor reporting, clinical heterogeneity, lack of variance data and methodological limitations in the eligible trials meant that no pooled comparisons were undertaken.  The authors concluded that there is no conclusive evidence about the superiority of any support surface for the treatment of existing pressure ulcers.  Methodological issues included variations in outcomes measured, sample sizes and comparison groups.  Many studies had small sample sizes and often there was inadequate description of the intervention, standard care and co-interventions.  Individual study results were often inadequately reported, with failure to report variance data common, thus hindering the calculation of mean differences.  Some studies did not report P values when reporting on differences in outcomes.  In addition, the age of some trials (some being 20 years old), meant that other technologies may have superseded those investigated.  They stated that further and rigorous studies are required to address these concerns and to improve the evidence base before firm conclusions can be drawn about the most effective support surfaces to treat pressure ulcers. 

Colin et al (2012) stated that the use of support surfaces in the prevention and treatment of pressure ulcers prevention is an important part of care for a patient at risk and/or suffering from sore(s).  These researchers examined which support surfaces to use in prevention and treatment of at-risk and/or pressure sore patients.  They performed a systematic review of the literature querying the several Pascal Biomed, PubMed and Cochrane Library databases from 2000 through 2010.  In prevention, a structured foam mattress is more efficient than a standard hospital mattress.  An alternating pressure mattress is more effective than a visco-elastic mattress limiting the occurrence heel pressure ulcers, but those that do occur are more serious.  A low-air-loss bed is more efficient than a mixed pulsating air mattress in prevention of heel pressure ulcers.  Some types of sheepskin can reduce sacral pressure ulcer incidence in orthopedic patients.  Use of an overlay on an operating table limits the occurrence of peri-operative and post-operative pressure ulcers.  An air-fluidized bed improves pressure ulcer healing.  The authors concluded that the data in the literature are not always relevant and do not suffice to dictate a clinician's choices.  These investigators noted that they were compelled to recognize the methodological limitations of many studies, the lack of corporate interest in conducting such studies and the relatively small number of available trials.  However, the effectiveness of some support surfaces reaches a sufficient level of evidence, especially when they are associated with postural, hydration and nutritional measures.  They stated that support surfaces are recommended in prevention and treatment of patients at risk and/or already suffering from pressure ulcer, and their use should constitute part of an overall preventive or curative strategy. 

Tricco et al (2015) stated that numerous, often multi-faceted regimens are available for treating complex wounds, yet the evidence of these interventions is recondite across the literature.  These researchers identified effective interventions to treat complex wounds through an overview of systematic reviews.  MEDLINE (OVID interface, 1946 until October 26, 2012), EMBASE (OVID interface, 1947 until October 26, 2012), and the Cochrane Database of Systematic Reviews (Issue 10 of 12, 2012) were searched on October 26, 2012.  Systematic reviews that examined adults receiving care for their complex wounds were included.  Two reviewers independently screened the literature, abstracted data, and assessed study quality using the Assessment of Multiple Systematic Reviews (AMSTAR) tool.  Overall, 99 systematic reviews were included after screening 6,200 titles and abstracts and 422 full-texts; 54 were systematic reviews with a meta-analysis (including data on over 54,000 patients) and 45 were systematic reviews without a meta-analysis.  Overall, 44 % of included reviews were rated as being of high quality (AMSTAR score greater than or equal to 8).  Based on data from systematic reviews including a meta-analysis with an AMSTAR score greater than or equal to 8, promising interventions for complex wounds were identified.  These included bandages or stockings (multi-layer, high compression) and wound cleansing for venous leg ulcers; 4-layer bandages for mixed arterial/venous leg ulcers; biologics, ultrasound, and hydrogel dressings for diabetic leg/foot ulcers; hydrocolloid dressings, electrotherapy, air-fluidized beds, and alternate foam mattresses for pressure ulcers; and silver dressings and ultrasound for unspecified mixed complex wounds.  For surgical wound infections, topical negative pressure and vacuum-assisted closure were promising interventions, but this was based on evidence from moderate to low quality systematic reviews.  The authors concluded that numerous interventions can be utilized for patients with varying types of complex wounds, yet few treatments were consistently effective across all outcomes throughout the literature.  Clinicians and patients can use these results to tailor effective treatment according to type of complex wound.  Network meta-analysis will be of benefit to decision-makers, as it will permit multiple treatment comparisons and ranking of the effectiveness of all interventions.

According to the Wound Systems website, the Dolphin Bed surface replaces the standard hospital bed mattress and is also available in bariatric sizes.  The pump/controller fits on the foot of the bed and includes an onboard rechargeable battery for power interruption protection and mobility.  Battery operation capability also permits the controller to be adapted to a wheelchair, providing a continuum of pressure reduction wound care and patient mobility.  The application of the Fluid Immersion Simulation technology provides dynamic pressure reduction adjustments every 11 seconds to keep the patient at equilibrium.  The Dolphin System is often used as a clinically effective, cost reduced alternative to Air Fluidized Therapy (AFT).

Appendix

Patients using pressure-reducing support surfaces should have a care plan, which has been established by the patient's physician and home care nurse, which is documented in the patient's medical records, and which generally should include the following:

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

The following are definitions and instructions relevant to interpretation of this policy.

Pressure Ulcer Staging:

The staging of pressure ulcers used in this policy is as follows:

Group 1 Support Surfaces:

The following are considered group 1 support surfaces: pressure pads for mattresses, non-powered pressure reducing mattresses, and powered pressure reducing mattress overlay systems.  Each of the support surfaces described below is considered medically necessary when criteria for group 1 support surfaces are met.

Pressure pads for mattresses are non-powered pressure-reducing mattress overlays.  These devices are designed to be placed on top of a standard hospital or home mattress.  Pressure pads for mattresses with the following features are considered medically necessary when criteria for group 1 support surfaces are met:

The above policy is based on the following references: