0482 Compression Garments for the Legs (1)

Compression Garments for the Legs - Medical Clinical Policy Bulletins | Aetna

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Compression Garments for the Legs

Number: 0482

Policy *Please see amendment forPennsylvaniaMedicaid

at the end of this CPB.

Note: Aetna's standard benefit plans do not cover graded compression stockings or non-elastic binders because they are considered an outpatient consumable or disposable supply. Please check benefit plan descriptions for details.

Inflatable compression garments*, non-elastic binders**, or individually fitted prescription graded compression stockings*** are considered medically necessary for members who have any of the following medical conditions:

I. Treatment of any of the following complications of

chronic venous insufficiency:

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Lipodermatosclerosis Stasis dermatitis (venous eczema) Varicose veins (except spider veins) Venous edema Venous ulcers (stasis ulcers)

Policy History

Last Review 08/09/2020 Effective: 08/24/2001 Next Review: 05/27/2021

Review History

Definitions

Additional Information

Clinical Policy Bulletin Notes

Compression Garments for the Legs - Medical Clinical Policy Bulletins | Aetna

II. Edema accompanying paraplegia, quadriplegia, etc. III. Edema following surgery, fracture, burns, or other trauma IV. Persons with lymphedema

(see CPB 0069 - Lymphedema (../1_99/0069.html))

V. Post sclerotherapy**** VI. Post-thrombotic syndrome (post-phlebitic syndrome) VII. Postural hypotension VIII. Prevention of thrombosis in immobilized persons (e.g.,

immobilization due to surgery, trauma, general debilitation, etc.) IX. Severe edema in pregnancy

These compression garments for the legs are considered experimental and investigational for all other indications (e.g., improvement of functional performance in individuals with Parkinson disease, improvement of knee proprioception in rehabilitation setting, management of delayed-onset muscle soreness, management of pain during post-natal care, and management of spasticity following stroke).

* The above reference to inflatable compression garments (e.g., Flowtron Compression Garment, Jobst Pneumatic Compressor) also includes the pump needed to inflate the compression garment. For Aetna's clinical policy on intermittent and sequential compression pumps for lymphedema, see CPB 0069 - Lymphedema (../1_99/0069.html), and CPB 0500 - Intermittent Pneumatic Compression Devices (../500_599/0500.html) .

**Aetna considers non-elastic leg binders (e.g., CircAid, LegAssist, Reid Sleeve) medically necessary for members who meet the selection criteria for pressure gradient support stockings listed above. Non-elastic leg binders are similar to graded compression stockings in that they provide static

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Compression Garments for the Legs - Medical Clinical Policy Bulletins | Aetna

compression of the leg, but unlike graded compression stockings, they do not use elastic, but use adjustable Velcro or buckle straps.

***Applies only to pre-made or custom-made pressure gradient support stockings (e.g., Jobst, Juzo, SigVarus, Venes, etc.) that have a pressure of 18 mm Hg or more, that require a physician's prescription, and that require measurements for fitting.

****Only pressure gradient support stockings are considered medically necessary for this indication; inflatable compression garments have no proven value for this indication.

Stockings purchased over the counter without a prescription which have a pressure of less than 20 mm Hg (e.g., elastic stockings, support hose, surgical leggings, anti-embolism stockings (Ted hose) or pressure leotards) are considered experimental and investigational because these supplies have not been proven effective in preventing thromboembolism. Note: These OTC stockings are also not covered because they are not primarily medical in nature.

Silver impregnated compression stockings are considered not medically necessary because there is insufficient evidence that silver impregnated compression stockings are superior to standard compression stockings.

Replacements

Replacements are considered medically necessary when the compression garment can not be repaired or when required due to a change in the member's physical condition. For pressure gradient support stockings, no more than 4 replacements per year are considered medically necessary for wear.

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Compression Garments for the Legs - Medical Clinical Policy Bulletins | Aetna

Two pairs of compression stockings are considered medically necessary in the initial purchase (the 2nd pair is for use while the 1st pair is in the laundry).

Contraindications

Compression garments are considered experimental and investigational for members with severe peripheral arterial disease or septic phlebitis because they are contraindicated in these conditions.

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Background

Compression garments are usually made of elastic material, and are used to promote venous or lymphatic circulation. Compression garments worn on the legs can help prevent deep vein thrombosis and reduce edema, and are useful in a variety of peripheral vascular conditions. Compression garments can come in varying degrees of compression. The higher degrees require a physician's prescription.

Fabric support garments are stockings or sleeves, usually made of elastic that may be utilized for, but not limited to, cases of severe edema, prevention of deep vein thrombosis (DVT), venous insufficiency or for certain burn injuries to lessen swelling and/or to reduce scarring. Alternatives to fabric support garments include dietary changes, exercise, limb elevation and weight control.

In an outcome-blinded, randomized controlled trial, Dennis et al (2009) evaluated the effectiveness of thigh-length graduated compression stockings (GCS) to reduce deep vein thrombosis (DVT) following stroke. A total of 2,518 patients who were admitted to hospital within 1 week of an acute stroke and who were immobile were enrolled from 64 centers in the United Kingdom, Italy, and Australia. Patients were allocated via a central randomization system to routine care plus thigh-length

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Compression Garments for the Legs - Medical Clinical Policy Bulletins | Aetna

GCS (n = 1,256) or to routine care plus avoidance of GCS (n = 1,262). A technician who was blinded to treatment allocation undertook compression Doppler ultrasound of both legs at about 7 to 10 days and, when practical, again at 25 to 30 days after enrolment. The primary outcome was the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral veins. Analyses were by intention-to-treat. All patients were included in the analyses. The primary outcome occurred in 126 (10.0 %) patients allocated to thigh-length GCS and in 133 (10.5 %) allocated to avoid GCS, resulting in a non-significant absolute reduction in risk of 0.5 % (95 % confidence interval [CI]: -1.9 % to 2.9 %). Blisters, ulcers, skin breaks, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use (64 [5 %] versus 16 [1 %]; odds ratio 4.18, 95 % CI: 2.40 to 7.27). The authors concluded that these findings do not lend support to the use of thigh-length GCS in patients admitted to hospital with acute stroke. National guidelines for stroke might need to be revised on the basis of these results.

The National Comprehensive Cancer Network's clinical practice guideline on venous thromboembolic disease (2010) states that GCS can be used in conjunction with a venous compression device as a method of mechanical prophylaxis.

Ibuki and colleagues (2010) examined the effect of 3 tonereducing devices (dynamic foot orthosis, muscle stretch, and orthokinetic compression garment) on soleus muscle reflex excitability while standing in patients with spasticity following stroke. A repeated measures intervention study was conducted on 13 patients with stroke selected from a sample of convenience. A custom-made dynamic foot orthosis, a range of motion walker to stretch the soleus muscle and class 1 and class 2 orthokinetic compression garments were assessed using the ratio of maximum Hoffmann reflex amplitude to maximum M-response amplitude (Hmax:Mmax) to determine their effect on soleus muscle reflex excitability. Only 10 subjects were able to complete the testing. There

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Compression Garments for the Legs - Medical Clinical Policy Bulletins | Aetna

were no significant treatment effects for the interventions (F = 1.208, df = 3.232, p = 0.328); however, when analyzed subjectby-subject, 2 subjects responded to the dynamic foot orthosis and 1 of those 2 subjects also responded to the class 1 orthokinetic compression garment. Overall, the results demonstrated that the tone-reducing devices had no significant effect on soleus reflex excitability suggesting that these tone-reducing orthotic devices have no significant neurophysiologic effect on spasticity.

Jaccard and colleagues (2007) noted that silver fibercontaining compression stockings for the use in patients with chronic venous insufficiency (CVI) were introduced to the market. In order to gain some first insight into the effects of these fabrics on the cutaneous microcirculation, a doubleblind, randomized cross-over trial was performed in 10 healthy volunteers. A 3 days run-in phase preceded the (2 x 10 days) treatment phases and was used to assess the reproducibility of the primary endpoint, which was the transcutaneous partial oxygen pressure (tcpO(2)) measured at a probe temperature of 44 degrees C in the peri-malleolar region of the reference leg in supine and dependent leg positions. Coefficients of variation for double measured tcpO(2) values were 4.2 % (3.1 SD) and 5.8 % (6.0 SD) for the leg in supine and dependent position. The intra-individual comparison of the effects from both treatment phases (value end of treatment - start of treatment) resulted in a negative tcpO(2) net balance for the regular hosiery (-0.93 (2.7 SD) mm Hg, supine; -1.1 (3.5 SD) mm Hg, dependent) but a positive net balance for the silver fibers containing stockings (0.25 (4.0 SD) mm Hg, supine; 1.7 (3.9 SD) mm Hg, dependent). The inter-treatment differences were statistically significant for the leg in a dependent position. The trial provides first evidence that interweaving silver threads into regular compression stockings may result in a positive effect regarding the nutritive skin perfusion. This was a small study done with healthy subjects; it is unclear whether these findings can be extrapolated to patients who require compression stockings.

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Compression Garments for the Legs - Medical Clinical Policy Bulletins | Aetna

In a Cochrane review, O'Meara et al (2012) noted that the main treatment for venous (or varicose or stasis) ulcers is the application of a firm compression garment (bandage or stocking) in order to aid venous return. There is a large number of compression garments available and it was unclear whether they are effective in treating venous ulcers and, if so, which method of compression is the most effective. These researchers performed a systematic review of all randomized controlled trials (RCTs) evaluating the effects on venous ulcer healing of compression bandages and stockings. Specific questions addressed by the review are: does the application of compression bandages or stockings aid venous ulcer healing? and which compression bandage or stocking system is the most effective? For this second update these investigators searched: the Cochrane Wounds Group Specialised Register (May 31, 2012); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 5, 2012); Ovid MEDLINE (1950 to May Week 4 2012); Ovid MEDLINE (InProcess & Other Non-Indexed Citations May 30, 2012); Ovid EMBASE (1980 to 2012 Week 21); and EBSCO CINAHL (1982 to May 30, 2012). No date or language restrictions were applied. Randomized controlled trials recruiting people with venous leg ulceration that evaluated any type of compression bandage system or compression stockings were eligible for inclusion. Eligible comparators included no compression (e.g., primary dressing alone, non-compressive bandage) or an alternative type of compression. Randomized controlled trials had to report an objective measure of ulcer healing in order to be included (primary outcome for the review). Secondary outcomes of the review included ulcer recurrence, costs, quality of life, pain, adverse events and withdrawals. There was no restriction on date, language or publication status of RCTs. Details of eligible studies were extracted and summarized using a data extraction table. Data extraction was performed by 1 review author and verified independently by a 2nd review author. A total of 48 RCTs reporting 59 comparisons were included (4,321 participants in total). Most RCTs were small, and most were at unclear or high-risk of

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Compression Garments for the Legs - Medical Clinical Policy Bulletins | Aetna

bias. Duration of follow-up varied across RCTs. Risk ratio (RR) and other estimates were shown below where RCTs were pooled; otherwise findings refer to a single RCT. There was evidence from 8 RCTs (unpooled) that healing outcomes (including time to healing) are better when patients receive compression compared with no compression. Singlecomponent compression bandage systems are less effective than multi-component compression for complete healing at 6 months (1 large RCT). A 2-component system containing an elastic bandage healed more ulcers at 1 year than one without an elastic component (1 small RCT). Three-component systems containing an elastic component healed more ulcers than those without elastic at 3 to 4 months (2 RCTs pooled), RR 1.83 (95 % CI: 1.26 to 2.67), but another RCT showed no difference between groups at 6 months. An individual patient data meta-analysis of 5 RCTs suggested significantly faster healing with the 4-layer bandage (4LB) than the short stretch bandage (SSB): median days to healing estimated at 90 and 99 respectively; hazard ratio 1.31 (95 % CI: 1.09 to 1.58). High-compression stockings were associated with better healing outcomes than SSB at 2 to 4 months: RR 1.62 (95 % CI: 1.26 to 2.10), estimate from 4 pooled RCTs. One RCT suggested better healing outcomes at 16 months with the addition of a tubular device plus single elastic bandage to a base system of gauze and crepe bandages when compared with 2 added elastic bandages. Another RCT had 3 arms; when 1 or 2 elastic bandages were added to a base 3-component system that included an outer tubular layer, healing outcomes were better at 6 months for the 2 groups receiving elastic bandages. There is currently no evidence of a statistically significant difference for the following comparisons: alternative single-component compression bandages (2 RCTs, unpooled); 2-component bandages compared with the 4LB at 3 months (3 RCTs pooled); alternative versions of the 4LB for complete healing at times up to and including 6 months (3 RCTs, unpooled); 4LB compared with paste bandage for complete healing at 3 months (2 RCTs, pooled), 6 months or 1 year (1 RCT for each

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