National Medical Policy

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1 National Medical Policy Subject: Policy Number: Air Fluidized Beds and Other Pressure Reducing Mattresses NMP423 Effective Date*: May 2008 Updated: November 2017 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Air-Fluidized Bed: X National Coverage Manual Citation Local Coverage Determination (LCD)* Pressure Reducing Support Surfaces - Group 1 Pressure Reducing Support Surfaces - Group 2 Pressure Reducing Support Surfaces - Group 3; X Article (Local)* Pressure Reducing Support Surfaces - Group 1 Pressure Reducing Support Surfaces - Group 2 Pressure Reducing Support Surfaces - Group 3 - Policy Article: X Other Medicare Coverage Issue Manual. Transmittal 128. Section 60-19, Air-Fluidized Beds (AFBs), is revised to define what is meant by conservative treatment that must be tried before a patient can qualify for coverage of an air-fluidized bed: Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 1

2 Guidance/Guidance/Transmittals/downloads/R12 8CIM.pdf None MLN Matters Number: MM8304 Revised. Related CR Release Date: May 31, Detailed Written Orders and Face-to-Face Encounters: Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/MM8304.pd f Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Group 2 Support Surfaces (powered pressure reducing mattresses etc.) Health Net, Inc. considers the group 2 support surfaces for treatment of pressure sores medically necessary when according to the following: OR OR Multiple stage II pressure ulcers located on the trunk or pelvis; and Patient 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; and, The ulcers have worsened or remained the same over the past month. Large (i.e. >8 square centimeters [length x width]) or multiple stage III or IV pressure ulcer(s) on the trunk or pelvis. Recent myocutaneous flap or skin graft for a pressure ulcer on the trunk or pelvis (surgery within the past 60 days), and The patient 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 above should generally include: 1. Education of the patient and caregiver on the prevention and/or management of pressure ulcers. 2. Regular assessment by a nurse, physician, or other licensed healthcare practitioner (usually at least weekly for a patient with a stage III or IV ulcer). 3. Appropriate turning and positioning. Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 2

3 4. Appropriate wound care (for a stage II, III, or IV ulcer). 5. Appropriate management of moisture/incontinence. 6. Nutritional assessment and intervention consistent with the overall plan of care. Continued Use Continued use of a group 2 support surface is 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 group 2 support surface is medically necessary for wound management Not Medically Necessary Group 2 support systems are considered not medically necessary for the following: Decubitus ulcer prevention, or Stage I pressure ulcers on the trunk or pelvis, or Pressure ulcer that is not located on the trunk or pelvis, or A single stage II decubitus ulcer on the trunk or pelvis (there must be multiple stage II pressure ulcers located on the trunk or pelvis), or Less than 30 day use of a group 1 support system, or Ulcer is not considered large which is generally defined as 8 square centimeters (length x width) or larger Group 3 Support Surfaces (Air fluidized Beds) Health Net, Inc. considers the air-fluidized bed for treatment of pressure sores medically necessary when all of the following criteria are met: 1. The patient has a stage 3 (full thickness tissue loss) or stage 4 (deep tissue destruction) pressure sore; and 2. The patient is bedridden or chair bound as a result of severely limited mobility; and 3. In the absence of an air-fluidized bed, the patient would require institutionalization; and 4. After completion of a course of *conservative treatment designed to optimize conditions that promote wound healing. This course of treatment must have been at least one month in duration without progression toward wound healing; 5. 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 6. A physician directs the home treatment regimen, and reevaluates and recertifies the need for the air-fluidized bed on a monthly basis; and 7. All other alternative equipment has been considered and ruled out. *Note - Conservative treatment must include all of the following: Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 3

4 1. Frequent repositioning of the patient with particular attention to relief of pressure over bony prominences (usually every 2 hours); and 2. Use of a specialized support surface (Group II) designed to reduce pressure and shear forces on healing ulcers and to prevent new ulcer formation; and 3. Necessary treatment to resolve any wound infection; and 4. Optimization of nutrition status to promote wound healing; and 5. Debridement by any means (including wet to dry dressings-which does not require an occlusive covering) to remove devitalized tissue from the wound bed; and 6. Maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings protected by an occlusive covering, while the wound heals. Not Medically Necessary Home use of the air-fluidized bed is considered not medically necessary under any of the following circumstances: 1. The patient has coexisting pulmonary disease (the lack of firm back support makes coughing ineffective and dry air inhalation thickens pulmonary secretions); or 2. The patient 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 3. The caregiver is unwilling or unable to provide the type of care required by the patient on an air-fluidized bed; or 4. Structural support is inadequate to support the weight of the air-fluidized bed system (it generally weighs 1600 pounds or more); or 5. Electrical system is insufficient for the anticipated increase in energy consumption; or 6. Other known contraindications exist. Abbreviations NPUAP National Pressure Ulcer Advisory Panel DTI Deep Tissue Injury AHCPR Agency for Health Care Policy and Research Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 4

5 On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes Pressure ulcer V49.84 Bed confinement status ICD-10 Codes L L89.95 Z74.Ø1 Pressure ulcer Bed confinement status CPT Codes N/A HCPCS Codes GROUP 2 E0193 E0277 E0372 E0373 GROUP 3 E0194 Powered air flotation bed (low air loss therapy) Powered Pressure Reducing Air Mattress. (Low Air Loss) Powered Air Overlay for mattress with low-air-loss feature Non-powered advanced pressure reducing mattress Air fluidized bed Scientific Rationale Update November 2012 McInnes et al (2012) assessed the effects of pressure-relieving support surfaces in the treatment of pressure ulcers. 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 two 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. The reviewers identified 18 trials of support surfaces for pressure ulcer treatment, involving 1309 participants with samples sizes that ranged from 14 to 160. Of three trials comparing air-fluidized devices with conventional therapy, two reported significant reductions in pressure ulcer size associated with air-fluidized devices. Due to lack of reported variance data they could not replicate the analyses. In relation to three 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 reviewers concluded 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), means that other technologies may have superseded those investigated.further and rigorous studies Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 5

6 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. Scientific Rationale Update - April 2009 (Group 2) Health Net follows Medicare guidelines for Group 2 pressure reducing support surfaces which typically include powered air floatation beds (low air loss therapy), powered pressure-reducing air mattresses, nonpowered advanced pressure reducing overlay for mattresses of standard length and width, powered air overlay for a mattress of standard length and width and nonpowered advanced pressure reducing mattresses. A low air loss bed is defined as a hospital bed with a fully integrated power pressure reducing mattress which has all of the following characteristics: An air pump or blower which provides either sequential inflation and deflation of the air cells or a low interface pressure throughout the mattress; Inflated cell height of the air cells through which the air being circulated is five inches or greater; 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; A surface designed to reduce friction and shear; and Can be placed directly on a hospital bed frame or ordinary bed frame. Scientific Rationale Initial In February 2007, the National Pressure Ulcer Advisory Panel (NPUAP) redefined the definition of a pressure ulcer and the stages of pressure ulcers, including the original four stages. Two additional stages were added, one on suspected deep tissue injury, which involves sub-dermal tissue damage that originates in muscle tissue, and one on unstageable pressure ulcers. A pressure ulcer is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction. Shear is a separate mechanism of tissue damage that results in ripping of deeper tissue layers, and it may not immediately cause a visible change in skin condition. Shear injury may manifest as bruising or changes in tissue temperature and color and, later, tissue sloughing and necrosis. Unlike friction, shear injury may cause deep tissue injury or damage. Friction is the force of two surfaces moving across one another. Friction and the increased drag coefficient that occurs when moving patients across bed sheets and other support surfaces can cause microscopic or macroscopic tissue trauma. The following are the redefined stages of pressure ulcers: Suspected Deep Tissue Injury (DTI): Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue. Deep tissue injury may be difficult to detect in individuals with dark skin tones. Evolution may include a thin blister over a dark wound bed. The wound may further evolve and become covered Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 6

7 by thin eschar. Progression may be rapid exposing additional layers of tissue even with optimal treatment. Stage I: Intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area. The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue. Stage I may be difficult to detect in individuals with dark skin tones. May indicate "at risk" persons (a heralding sign of risk). Stage II: Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister. Presents as a shiny or dry shallow ulcer without slough or bruising.* This stage should not be used to describe skin tears, tape burns, perineal dermatitis, maceration or excoriation. *Note - Bruising indicates suspected deep tissue injury. Stage III: Full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling. The depth of a stage III pressure ulcer varies by anatomical location. ** In contrast, areas of significant adiposity can develop extremely deep stage III pressure ulcers. Bone/tendon is not visible or directly palpable. Stage IV: Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed. Often include undermining and tunneling. The depth of a stage IV pressure ulcer varies by anatomical location. ** Stage IV ulcers can extend into muscle and/or supporting structures (e.g., fascia, tendon or joint capsule) making osteomyelitis possible. Exposed bone/tendon is visible or directly palpable. **Note - The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and stage III and IV ulcers can be shallow. Unstageable: Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined. Stable (dry, adherent, intact without erythema or Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 7

8 fluctuance) eschar on the heels serves as "the body's natural (biological) cover" and should not be removed. There are numerous techniques that can be used to decrease pressure to an affected site. Among these are increasing mobility through physical therapy and repositioning the patient while in bed or while up in a chair. The U.S. Agency for Health Care Policy and Research (AHCPR) recommends that any individual in bed who is assessed to be at risk for developing pressure ulcers should be repositioned at least every 2 hours if consistent with overall patient goals, and a written schedule for systematically turning and repositioning the individual should be used. For those patients who are at high risk and are up in a chair, repositioning should occur every hour. The turning schedules that were developed in the past, however, do not take into account the modern pressure-reducing devices, both for beds and for chairs, which may allow turning intervals to be decreased without increasing risk of pressure ulcer development. The Centers of Medicare and Medicaid Medicare (CMS) classify specialty mattresses into three groups, and patients must meet the following clinical criteria: Group 1 (static overlays and replacement mattresses); Group 2 (low-air-loss beds, alternating pressure, and powered or nonpowered overlays or mattresses); and Group 3 (air-fluidized beds). Most surfaces are pressure reducing, but do not decrease pressure below capillary closing pressure of 32 mm Hg; patients continue to require repositioning every 2 hours to allow for tissue recovery. The only true pressure-relieving surface is the air-fluidized bed, which is used for patients after flap surgeries, for patients who have no turning surfaces, or for those who meet the specific criteria noted in the policy statement. An air-fluidized bed consists of a tank filled with silicone-coated microsphere beads. The beads resemble fine 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 of the unit, then filtered, heated, and pushed into the tank through a diffuser board. The airflow suspends the beads causing them to take on the properties of a fluid. The sheet moves freely with the patient through the fluid. Usually the patient only sinks 4-6 inches into the beads and the pressure put on the skin is well below capillary closing pressure. The filter sheet is permeable to the warm air that fluidizes the beads. This airflow circulates around the patient and helps to keep the patient warm and dry. The sheet is also permeable to the downward flow of body fluids such as wound drainage, urine, and perspiration. As body fluid comes in contact with the beads, the beads clump and drop to the bottom of the tank. The alkaline environment of the beads kills bacteria. The clumps are removed during routine maintenance. Patient transfers in and out of the bed may be difficult and in most models the head of the bed cannot be elevated. When the airflow is turned off, the beads settle into a mold around the body. This creates a support surface that stabilizes the patient for nursing care, wound cleaning, and other patient care needs. Examples of the air-fluidized bed include the Clinitron, Fluid Air, and Mediscus Heavy Duty System. The information in this clinical policy is based on criteria from the Centers of Medicare and Medicaid (CMS) and on the recommendations of the Agency for Health Care Policy and Research (AHCPR) Treatment of the Pressure Ulcers Guidelines Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 8

9 Panel. Additional, larger, randomized controlled trials are needed to compare the different types of pressure support surfaces and their effects on wound healing. Review History May 2008 April 2009 November 2011 November 2012 November 2013 November 2014 November 2015 November 2016 Medical Advisory Council Added Section on Group 2 Support Surfaces Update. Added revised Medicare Table with link to NCD, LCDs, articles, MLN Matters, etc. No revisions. Update no revisions Update no revisions. Codes updated. Update no revisions Update no revisions Update - no revisions. Codes reviewed. This policy is based on the following evidence-based guidelines: 1. Bergstrom N, Bennett MA, Carlson CE, et al. Pressure Ulcer Treatment. Clinical Practice Guideline. Quick Reference Guide for Clinicians, No. 15. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research. AHCPR Pub. No Modified Dec 12, National Institute for Health and Clinical Excellence. NICE guideline on pressure ulcer risk management and prevention (Guideline B) Cullum N, McInnes E, Bell-Syer SEM, et al. Support surfaces for pressure ulcer prevention. The Cochrane Database of Systematic Reviews 2004, Issue 3. Art. 4. National Pressure Ulcer Advisory Panel (NPUAP). NPUAP Staging Report. Updated Nov Available at: 5. National Collaborating Centre for Nursing and Supportive Care. The use of pressure-relieving devices (beds, mattresses and overlays) for the prevention of pressure ulcers in primary and secondary care. National Institute for Clinical Excellence (NICE); 2003 Oct. 6. Wound, Ostomy, and Continence Nurses Society (WOCN). Guideline for prevention and management of pressure ulcers. Glenview (IL): Wound, Ostomy, and Continence Nurses Society (WOCN); p. 7. U.S. Agency for Healthcare Research and Quality. Center for Practice and Technology Assessment. Air-Fluidized Beds Used for Treatment of Pressure Ulcers in the Home Environment. Health Care Technology Assessment. Medicare Coverage Policy ~ Decisions. Pressure Reducing Therapy (#CAG-00017N) November 7, Hayes. Medical Technology Directory. Pressure-Reducing Support Surfaces for Pressure Ulcers. May 24, Archived June 2015 References Update November McGinnis E, Stubbs N. Pressure-relieving devices for treating heel pressure ulcers. Cochrane Database Syst Rev Feb 12;2:CD Tricco AC, Antony J, Vafaei A, et al. Seeking effective interventions to treat complex wounds: an overview of systematic reviews. BMC Med Apr 22;13: Yoshikawa Y, Maeshige N, Sugimoto M, et al. Positioning bedridden patients to reduce interface pressures over the sacrum and great trochanter. J Wound Care Jul;24(7): References Update November Smith ME, Totten A, Hickam DH, et al. Pressure ulcer treatment strategies: a systematic comparative effectiveness review. Ann Intern Med Jul 2;159(1):39-50 Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 9

10 References Update November Institute for Clinical Systems Improvement (ICSI). Pressure ulcer prevention and treatment protocol. Health care protocol. January Available at: Support+Surfaces References Update November McInnes E, Dumville JC, Jammali-Blasi A, Bell-Syer SE. Support surfaces for treating pressure ulcers. Cochrane Database Syst Rev Dec 7;(12):CD References Update November McInnes E, Jammali-Blasi A, Bell-Syer SE, et al. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev Apr Medicare Learning Network (MLN). Medicare Policy Regarding Pressure Reducing Support Surfaces References Update April Medicare LCD for Pressure Reducing Support Services Group 2 (L5068) References Initial 1. 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): Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: A systematic review. JAMA. 2006;296(8): Thomas DR. Pressure ulcers. Conn s Current Therapy Section Garcia DA, Thomas DR. Assessment and Management of Chronic Pressure Ulcers in the Elderly Medical Clinics of North America - Volume 90, Issue 5 (September 2006). 5. Zulkowski K, Langemo D, Posthauer ME, et al. Coming to consensus on deep tissue injury. Adv Skin Wound Care (2005) 18 : pp Jalali R, Rezaie M. Predicting pressure ulcer risk: comparing the predictive validity of 4 scales. Adv Skin Wound Care (2005) 18 : pp Ochs RF, Horn SD, van Rijswijk L, et al. Comparison of air-fluidized therapy with other support surfaces used to treat pressure ulcers in nursing home residents. Ostomy Wound Manage Feb;51(2): Available at: 8. Ankrom M, Bennett R, Sprigle S, et al. Pressure-related deep tissue injury under intact skin and the current pressure ulcer staging systems. Adv Skin Wound Care (2005) 18 : pp Brillhart B. Pressure sore and skin tear prevention and treatment during a 10- month program. Rehabil Nurs. 2005; 30(3): de Laat EH, Scholte op Reimer WJ, van Achterberg T. Pressure ulcers: diagnostics and interventions aimed at wound-related complaints: a review of the literature. J Clin Nurs. 2005; 14(4): Cole L, Nesbitt C. A three year multiphase pressure ulcer prevalence/incidence study in a regional referral hospital. Ostomy Wound Manage. 2004; 50(11): Cullum N, McInnes E, Bell-Syer SEM, et al. Support surfaces for pressure ulcer prevention. The Cochrane Database of Systematic Reviews 2004, Issue 3. Art. 13. ECRI. Beds, air-fluidized; low-air-loss; mattress systems, alternating pressure; low-air-loss. ECRI; 2004 Apr 23. Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 10

11 14. Brem H, Lyder C. Protocol for the successful treatment of pressure ulcers. Am J Surg (2004) S 17S. 15. Black, J. (2003). Deep tissue injury. Wounds: A compendium of clinical research and practice 15 (11), Pike S, Kitzmiller WJ. Pressure Sores: Prevention and Treatment Ch Ayello EA, Braden B. How and why to do pressure ulcer risk assessment. Adv Skin Wound Care (2002) 15 : pp Sprigle S, Linden M, McKenna D, et al. (2001). Clinical skin temperature measurement to predict incipient pressure ulcers. Advances in Skin and Wound Care. 14 (3), National Pressure Ulcer Advisory Panel. (2001). Pressure ulcers in America: Prevalence, incidence, and implications for the future. 20. Singhal K, Reis G, Kerstein M.D. Options for nonsurgical debridement of necrotic wounds. Adv Skin Wound Care (2001) 21. Pressure ulcer prevention and treatment following spinal cord injury: a clinical practice guideline for health-care professionals. J Spinal Cord Med 2001 Spring; 24(Suppl 1):S Centers for Medicare and Medicaid Services. NCD for Air-Fluidized Bed. Effective 11/ Bernath V. Prevention of pressure ulcers. Clayton, Victoria, Australia: Centre for Clinical Effectiveness (CCE); Land L, Evans D, Geary A, et al. A clinical evaluation of an alternating-pressure mattress replacement system in hospital and residential care settings. J Tissue Viability 2000 Jan;10(1): Paralyzed Veterans of America. Pressure ulcer prevention and treatment following spinal cord injury: A clinical practice guideline for health care professionals. Washington (DC): Paralyzed Veterans of America; 2000 Aug. 94 p. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 11

12 Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Air Fluidized Beds and Other Pressure Reducing Mattresses Nov 17 12

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