Number: Policy *Please see amendment for Pennsylvania Medicaid at the end. Last Review 01/26/2017 Effective: 10/23/1995 Next Review: 01/25/2018

Transcription

1 1 of 9 Number: 0062 Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB. Aetna considers burn garments and associated physical and occupational therapy medically necessary when all of the following criteria are met: The burn is of documented significance to place the member at risk of a post burn contracture; and The burn garment and physical and occupational therapies are being used with the intent of preventing the need for skin grafting or contractures as a result of hypertrophic scarring; and The burn garment is authorized by the primary care physician and/or the treating specialist. Last Review 01/26/2017 Effective: 10/23/1995 Next Review: 01/25/2018 Review History Definitions Aetna considers the use of support garments for scar minimization of the donor site experimental and investigational because their effectiveness for this indication has not been established. Clinical Policy Bulletin Notes Note: Burn garments, such as inflatable compression garments used with a pump to apply controlled pressure to stimulate circulation, are considered durable medical equipment (DME).

2 2 of 9 Please check benefit plan descriptions for details on DME coverage. See also CPB 0172 Hyperbaric Oxygen Therapy (HBOT) (../100_199/0172.html), CPB 0250 Occupational Therapy Services (../200_299/0250.html), CPB 0389 Hypertrophic Scars and Keloids (../300_399/0389.html), and CPB 0482 Compression Garments for the Legs (../400_499/0482.html). Background Burn patients frequently require prolonged follow up care after injury. Follow up is typically done as an outpatient to a burn clinic where the patient is seen by a burn therapist. Positioning, splinting, exercise, and pressure garments help preserve function and appearance as burn wounds heal. Body surfaces with high skin tension and movement (e.g., chest, face, hands, joints, and upper legs) are most susceptible to scarring and contractures. Follow up visits are initially scheduled 7 to 14 days after discharge, and then every 1 to 2 weeks for the next 2 months, finally every month for about 3 months, and then every 3 months until their hypertrophic scar matures and they no longer need compression garments (usually a period of 12 months). Standard care for the prevention of abnormal scarring after burn injury includes pressure garment therapy (PGT); however, it is associated with potential patient morbidity and high costs. In a meta analysis, Anzarut et al (2009) examined the effectiveness of PGT for the prevention of abnormal scarring following burn injury. This study had 3 aims: (i) to conduct a systematic review to identify the available evidence for the use of pressure garment therapy (PGT); (ii) to assess the quality of the available evidence; and (iii) to conduct a meta analysis to quantify the effectiveness of PGT for the prevention of abnormal scarring following burn. Randomized control trials were identified from CINHAL, EMBASE, MEDLINE, CENTRAL, the "grey literature" and hand searching of the Proceedings of the American Burn Association. Primary authors and pressure garment manufacturers were contacted to identify eligible

3 3 of 9 trials. Bibliographies from included studies and reviews were searched. Study results were pooled to yield weighted mean differences (WMD) or standardized mean difference (SMD) and reported using 95 % confidence intervals (CIs). The review incorporated 6 unique trials involving 316 patients. Original data from 1 unpublished trial were included. Overall, studies were considered to be of high methodological quality. The meta analysis was unable to demonstrate a difference between global assessments of PGT treated scars and control scars (WMD: 0.46; 95 % CI: 1.07 to 0.16). The meta analysis for scar height showed a small, but statistically significant, decrease in height for the PGT treated group (SMD: 0.31; 95 % CI: 0.63 to 0.00). Results of meta analyses of secondary outcome measures of scar vascularity, pliability and color failed to show a difference between groups. The authors concluded that PGT does not appear to alter global scar scores. It does appear to improve scar height, although this difference is small and of questionable clinical importance. The beneficial effects of PGT remain unproven, while the potential morbidity and cost are not insignificant. Given current evidence, additional research is needed to ascertain the effectiveness, risks and costs of PGT. There is a lack of evidence that pressure garments and silicone sheeting result in improved outcomes compared to pressure garments alone. In a pilot study, Harte et al (2009) examined if pressure and silicone therapy used simultaneously are more effective in treating multiple characteristics of hypertrophic scars than pressure alone. A total of 22 subjects with hypertrophic burn scars were randomized to receive Jobskin pressure garments and Mepiform silicone sheeting or Jobskin pressure garments alone. The Vancouver Scar Scale (VSS) was used to measure multiple scar characteristics at baseline, week 12, and week 24. No statistically significant difference was found in the rate of change of the VSS scores between the pressure therapy (PT) group and the PT plus silicone group at week 12 or week 24; however, the mean scores of both groups decreased over 24 weeks. There were no statistically significant changes in the VSS subscores (pigmentation, pliability, scar height, and vascularity) from

4 4 of 9 baseline to week 12 or week 24. A statistically significant relationship was observed between the VSS score and total burn surface area (less than 30 %) in the PT group at baseline (p < 0.05), over 12 weeks (p < 0.05), and over 24 weeks (p < 0.05). The authors noted that given the limitations of this study, especially the small sample size, further research is needed before any firm conclusions can be drawn on this therapy approach. However, this pilot study has discussed the recurring issues in the research regarding these controversial treatments and has yielded potential for further investigation in a fully powered randomized controlled trial. Atiyeh and associates (2013) noted that hypertrophic burn scars pose a challenge for burn survivors and providers. In many cases, they can severely limit a burn survivor's level of function, including work and recreational activities. A widespread modality of prevention and treatment of hypertrophic scarring is the utilization of pressure garment therapy (PGT). Despite the magnitude of the problem of hypertrophic scarring and the ubiquitous use of PGT, strong clinical evidence of the effectiveness of PGT in the literature is lacking. Some of the challenges facing measurement of the effectiveness of PGT on hypertrophic scarring are lack of clear definitions for degree of hypertrophic scarring, inability to quantify pressure applied to scars, patient non compliance to strict PGT time schedules, as well as the inability to conduct randomized controlled trials (RCTs) comparing PGT to no therapy for ethical reasons since PGT is considered a standard of care. Scar Minimization of the Donor Site: Donovan and colleagues (2016) stated that PGT is well accepted and commonly used by clinicians in the treatment of burns scars and grafts. The medium to high pressures (24 to 40 mmhg) in these garments can support scar minimization, and evidence is well documented for this particular application. However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well documented. This study protocol investigates the impact of a low pressure (4 to 6

5 5 of 9 mmhg) interim garment on donor site healing and scarring. With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been 2 fold. Interim pressure garments for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management. However, anecdotal and observational evidence suggested that IPGs also made a difference to some patient's scar outcomes for donor sites. This study protocol outlines a RCT designed to test the effectiveness of this treatment on reducing scarring to burn donor sites. This study is a single center, single (assessor) blinded, RCT in patients with burns donor sites to their thighs. Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment. Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days). The IPG treatment will be administered post operatively (on day 5). Follow up assessments and garment replacement will be undertaken fortnightly for a period of 2 months. This study focuses on a unique area of burns scar management using a low pressure tubular support garment for the reduction of donor site scars. Such therapy specifically for donor scar management is poorly represented in the literature. This study was designed to test a potentially cost effective scar prevention for patients with donor sites to the thigh. The authors noted that no known studies of this nature have been carried out to date, and there is a need for rigorous clinical evidence for low pressure support garments for donor site scar minimization. CPT Codes / HCPCS Codes / ICD 10 Codes Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+": ICD 10 codes will become effective as of October 1, 2015 :

6 6 of 9 Other CPT codes related to the CPB: Physical medicine and rehabilitation Modalities, supervised Modalities, constant attendance Therapeutic procedures HCPCS codes covered if selection criteria are met: A6501 A6502 A6503 A6504 A6505 A6506 A6507 A6508 A6509 A6510 A6511 A6512 Compression burn garment, bodysuit (head to foot), custom fabricated Compression burn garment, chin strap, custom fabricated Compression burn garment, facial hood, custom fabricated Compression burn garment, glove to wrist, custom fabricated Compression burn garment, glove to elbow, custom fabricated Compression burn garment, glove to axilla, custom fabricated Compression burn garment, foot to knee length, custom fabricated Compression burn garment, foot to thigh length, custom fabricated Compression burn garment, upper trunk to waist including arm openings (vest), custom fabricated Compression burn garment, trunk, including arms down to leg openings (leotard), custom fabricated Compression burn garment, lower trunk including leg openings (pantry), custom fabricated Compression burn garment, not otherwise classified

7 7 of 9 A6513 Compression burn mask, face, and/or neck, plastic or equal, custom fabricated Other HCPCS codes related to the CPB: G0151 G0152 S8990 S9129 S9131 Services performed by a qualified physical therapist in the home health or hospice setting, each 15 minutes Services performed by a qualified occupational therapist in the home health or hospice setting, each 15 minutes Physical or manipulative therapy performed for maintenance rather than restoration Occupational therapy, in the home, per diem Physical therapy; in the home, per diem ICD 10 codes covered if selection criteria are met: T20.00x+ T26.92x+ T30.0 T32.99 Burns The above policy is based on the following references: 1. Byl N, Cameron M, Kloth LC, Rosenberg Zellerback L. Treatment and prevention: Goals and objectives. In: Saunders Manual of Physical Therapy Practice. R Sgarlat Myers, ed., Philadelphia, PA: WB Saunders Company; 1995: Rivers EA, Fisher ST. Rehabilitation for burn patients. In: Krusen's Handbook of Physical Medicine and Rehabilitation. 4th ed. FJ Kottke, JF Lehmann. eds. Philadelphia, PA: WB Saunders Company; 1990: Wienert V. Compression treatment after burns. Wien Med Wochenschr. 1999;149(21 22): Rose MP, Deitch EA. The clinical use of a tubular compression bandage, Tubigrip, for burn scar therapy: A

8 8 of 9 critical analysis. Burns Incl Therm Inj. 1985;12(1): Staley MJ, Richard RL. Use of pressure to treat hypertrophic burn scars. Adv Wound Care. 1997;10(3): King SD, Blomberg PA, Pegg SP. Preventing morphological disturbances in burn scarred children wearing compressive face garments. Burns. 1994;20(3): Puzey G. The use of pressure garments on hypertrophic scars. J Tissue Viability. 2002;12(1): Rappoport K, Müller R, Flores Mir C. Dental and skeletal changes during pressure garment use in facial burns: A systematic review. Burns. 2008;34(1): Anzarut A, Olson J, Singh P, et al. The effectiveness of pressure garment therapy for the prevention of abnormal scarring after burn injury: A meta analysis. J Plast Reconstr Aesthet Surg. 2009;62(1): Harte D, Gordon J, Shaw M, et al. The use of pressure and silicone in hypertrophic scar management in burns patients: A pilot randomized controlled trial. J Burn Care Res. 2009;30(4): Engrav LH, Heimbach DM, Rivara FP, et al. 12 Year within wound study of the effectiveness of custom pressure garment therapy. Burns. 2010;36(7): Endorf FW, Ahrenholz D. Burn management. Curr Opin Crit Care. 2011;17(6): Atiyeh BS, El Khatib AM, Dibo SA. Pressure garment therapy (PGT) of burn scars: Evidence based efficacy. Ann Burns Fire Disasters. 2013;26(4): Donovan ML, Muller MJ, Simpson C, et al. Interim pressure garment therapy (4 6 mmhg) and its effect on donor site healing in burn patients: Study protocol for a randomised controlled trial. Trials. 2016;17(1):214.

9 9 of 9 Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change. Copyright Aetna Inc.

10 AETNA BETTER HEALTH OF PENNSYLVANIA Amendment to Aetna Clinical Policy Bulletin Number: CPB 0062 Burn Garments There are no amendments for Medicaid Updated 05/2017