Compression Garments for the Legs

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 for Pennsylvania Medicaid 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:

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

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

POLICY HISTORY Last Review: 06/17/2021 Effective: 08/24/2001 Next Review: 05/12/2022

Review History

Definitions

Additional Information

Clinical Policy Bulletin Notes

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

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 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.

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

**** 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.

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.

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.

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

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 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 tone-reducing

devices (dynamic foot orthosis, muscle stretch, and orthokinetic

compression garment) on soleus muscle reflex excitability while standing

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

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 were no significant treatment effects for the interventions (F = 1.208, df = 3.232, p = 0.328); however, when analyzed subject-by-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 fiber-containing 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 double-blind, 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 intertreatment 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 compressionstockings.

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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 Specialized 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 (In-Process & 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 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. Single-component 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

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

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 4LBfor 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 time point); adjustable compression boots compared with paste bandages for the outcome of change in ulcer area at 3 months (1 small RCT); adjustable compression boots compared with the 4LB with respect to complete healing at 3 months (1 small RCT); single-layer compression stocking

compared with paste bandages for outcome of complete healing at 4 months (1 small RCT) and 18 months (another small RCT); low compression stocking compared with SSB for complete healing at 3 and 6 months (1 small RCT);compression stockings compared with a 2 component bandage system and the 4LB for the outcome of complete healing at 3 months (1 small, 3-armed RCT); and tubular compression compared with SSB (1 small RCT) for complete healing at 3 months. Secondary outcomes: 4LB was more cost-effective than SSB. It was not possible to draw firm conclusions regarding other secondary outcomes including recurrence, adverse events and health-related quality of life. The authors concluded that compression increases ulcer healing rates compared with no compression. Multi-component systems are more effective than single-component systems. Multi-component systems containing an elastic bandage appear to be more effective than those

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

composed mainly of inelastic constituents. Two-component bandage systems appear to perform as well as the 4LB. Patients receiving the 4LB heal faster than those allocated the SSB. More patients heal on high-compression stocking systems than with the SSB. They stated that further data are required before the difference between high-compression stockings and the 4LB can be established.

Improvement of Functional Performance in Individuals with Parkinson Disease

Southard and colleagues (2016) noted that symptoms of Parkinson's disease (PD) include bradykinesia, gait abnormalities, balance deficits, restless leg syndrome, and muscular fatigue. Compression garments (CG) have been shown to improve performance in athletes by increasing venous return and reduce lactic acid. These researchers evaluated the effect of CG on the performance of 3 standardized functional tests in persons with PD. The functional tests selected represented strength, endurance, and mobility measures in individuals with PD. A total of 19 males and 2 females (aged 48 to 85 years) with PD participated in this cross-over design study. Subjects were randomly assigned to test under 2 conditions on 2 separate days: (i) wearing below knee CG, and (ii) wearing sham stockings. Outcome measures included 5 Times Sit to Stand (5XSTS), gait speed, and 6 Minute Walk Test (6MWT). There were 7 days between trials. A paired t-test was used for each dependent variable. Significance was set at p < 0.05. There were no significant

differences found between the CG and sham socks for all outcome measures. Paired t-tests for the dependent variables were gait speed (p = 0.729); 5XSTS (p = 0.880); 6MWT (p = 0.265); and rate of perceived exertion (RPE) (p = 1.00). The authors concluded that data to support the use of CG for enhanced proprioception, muscle power, speed, and endurance is in need of further study with the PD population. In particular, it is recommended that future studies evaluate the possible physiological benefits of CG when worn during exercise interventions.

Improvement of Knee Proprioception in Rehabilitation Setting

In a counter-balanced, single-blinded, cross-over study, Ghai and associates (2018) examined the influence of below-knee CG on proprioception accuracy under differential information processing constraints designed to cause high or low conscious attention to the task. A total of 44 healthy participants (26 males/18 females) with a mean age of 22.7 ? 6.9 years performed an active joint re-positioning task using

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