CLINICAL

Overview

This topic describes the role of gradient compression stocking, a subtype of compression therapy, in the management of venous leg ulcer (VLU). Venous leg ulcer (VLU) is discussed in detail elsewhere (See “Venous Ulcers - Overview”). For a high-level overview on the general use of compression therapy for VLU, please see “Compression Therapy”.

Background

• Compression therapy is considered the mainstay of VLU treatment [5] and along with standard care has the potential to heal 50%-75% of VLUs.[5][6]
• Gradient compression stockings are a type of elastic compression device that can be used for patients with small, uncomplicated VLU who wish to self-care, who find bandages too hot or bulky [1][2][3], and who do not present with morbid obesity, lipodermatoesclerosis or severe edema.[3] A large trial concluded that two-component gradient compression stockings (HH) is a viable first-line alternative to the four-component bandage to heal VLU, as these types of compression modalities resulted in similar effectiveness [3][7]
• Gradient compression stockings are subject to less operator variability than bandages [5] and are a good option for self-management or when clinicians skilled at application of compression bandages are not available.
• Clinical guidelines for VLU recommend lifelong [8] use of gradient compression stockings to decrease risk of recurrence [9][10], but 30-65% of patients do not adhere to use of compression stocking.[11][12] Commonly cited reasons include pain, discomfort, difficulty donning the stockings, perceived ineffectiveness, excessive heat, skin irritation, cost and appearance.[2][11][12]
• Gradient compression stockings are part of a category of products called compression stockings, which also include anti-embolism stockings and non-medical support hosiery. [12]
• • Gradient compression stockings are suited for ambulatory patients, and are manufactured under strict medical and technical specifications to provide a specific level of pressure at the ankle
  • Anti-embolism stockings decrease the risk of deep vein thrombosis in bedridden patients and are commonly used in the hospital setting (white stockings)
  • Non-medical support hosiery is often used to provide relief to symptoms such as tired, heavy legs and are sold over the counter without a prescription. They usually exert considerably lower levels of compression than graduated medical compression stockings.

How the intervention might work

• Stockings usually work by applying the highest level of pressure at the ankle and by gradually decreasing pressure towards the upper part of the garment. The pressure gradient ensures that blood flows upward toward the heart instead of refluxing downward to the foot or laterally into the superficial veins. Gradient compression can reverse venous hypertension, increase function of calf-muscle pump and facilitate venous return.[12][13]
• A new type of stocking that exerts higher pressure at the calf and gradually decreases pressure towards the ankle (progressive compressive stockings) has shown high levels of effectiveness, possibly due to the more pronounced effect on venous pumping function. However, their use in chronic venous disease is still considered investigational (Figure 1).[14][15]

Figure 1. Gradient and progressive compression systems

For more information on the mechanism of action of compression therapies, please see “Compression therapy for venous ulcers”, section ‘How the intervention might work’.

Pressure levels

Gradient compression stockings come in different graduated pressure levels. Gradient compression stockings are classified according to the pressure applied by the garment at the ankle level. Unfortunately, there is no single standard used to classify the degree of pressure worldwide, which may cause confusion. However, in the U.S. graduated compression stockings can be generally classified as shown in Table 1 below:

Table 1: Classification of gradient compression stockings by pressure level

Different features of gradient compression stockings

Gradient compression stockings can have different features and characteristics according to:

• Materials: gradient compression stockings are elastic due to elastomeric fibers. They can be made of different materials such as wool, spandex, nylon, silicone and latex. As such, their handling and elasticity vary accordingly. There are also latex-free stockings for patients with latex sensitivity.
• Styles: although knee-high compression stockings can satisfy the needs of the majority of patients with chronic venous disease, there are other types of compression hosiery, such as thigh-high, standard pantyhose, maternity pantyhose and chaps (unilateral waist high). Stockings can also have closed or open toe, and can have zippers (Figure 2)
• Fit: some brands can be custom fitted, others can be semi-custom fit by selecting the garment that best accommodates the patient’s ankle and calf girth and extremity length. Custom fitted stockings are preferred over semi-custom stockings, as it has been shown that there is a lack of standardized measuring methods in the selection of semi-custom compression stockings. Poor fit will not properly aid in healing or prevention of VLU recurrence [16]
• Components: single-component or double component. A two-component system (HH) is safer and easier to use than a single-component stocking: the first stocking (10–24 mmHg) holds the dressing in place and the second stocking (20–30mmHg) can be removed at night (Figure 2)

See features of different brands with Gradient compression stockings – Compare brands tool

Figure 2. Gradient compression stocking with two layers and zippers

Indications

By condition:

Chronic venous disease (see CEAP classification in “Venous Ulcer”, section ‘Documentation’, see recommendations, rationales and evidence in “Venous Ulcer”, section ‘Compression’):

• Active VLU (C5): Although sustained compression of at least 40 mmHg with a four-component compression bandage is considered gold standard, high-pressure compression stockings and other kinds of compression bandages (two or three-layer compression bandages, Unna boot, paste bandages) have been shown to be equally effective, as long as the clinician supervising the treatment is familiar with their use [3] [12] [14]. A randomized clinical trial with 457 patients concluded that two-component compression hosiery (HH) is a viable alternative to the four-component bandage, as it has similar healing rates. However, the higher rate of treatment changes among patients who used hosiery suggests that it might not be suitable for all patients  [3] [7]. It is particularly beneficial for patients with small, uncomplicated ulcers who wish to self-care, who require daily skin care, or who find bandages too hot or bulky. Due to the lack of padding it is not a practical option for patients at high risk of pressure damage, with large ulcers or high exudate levels [1]. Although higher pressure levels are preferred, if patient cannot tolerate high compression, clinicians can decrease the pressure level, as some compression is better than none [5]
• Prevention of ulcer recurrence after venous leg ulcer has healed (C6): to decrease recurrence, patients with indications for vascular interventions should undergo vascular surgery, in addition to wearing compression stockings [17]at the highest level of compression tolerated, preferably 25-35 mmHg at the ankle level [14]. See more information on vascular interventions in “Venous Ulcer”, section ‘Vascular Surgical Interventions’. If patient is not a surgical candidate, compression stockings are the definite, life-long treatment [4] [14]
• Spider veins and reticular varices (C1), varicose veins (C2), edema (C3) and skin changes (C4), with heavy, tired legs:  There is insufficient, high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins (C2)  [18]., but there is ample low quality evidence based on non-randomized clinical trials and clinical experience, that suggest the use of graduated compression stockings to improve patient symptoms and they improve patients' quality of life (QoL) [14].
• Post-venous intervention: It has been shown that wearing compression stockings (23 to 32 mm Hg) for 3 weeks enhances the efficacy of sclerotherapy of leg telangiectasias by improving clinical vessel disappearance  [19]. Also, after endovenous vein ablation, use of high compression profile (35 mmHg) elastic stockings for 7 days significantly reduced pain and improved both physical function and vitality when compared with use for 2 days [19].

Deep vein thrombosis prophylaxis:

• There is low to moderate quality evidence that stockings provide effective prophylaxis against deep vein thrombosis in medically ill patients, and low-quality evidence support their use to prevent deep vein thrombosis in general surgical and orthopedic patients. [12]

Lymphedema

• Graduated compression stockings are effective in long-term management of lymphedema [12].

Superficial thrombophlebitis:

• For superficial thrombophlebitis, there may be some benefit in wearing graduated compression stockings in combination with surgery [12] [20]

Post-thrombotic syndrome:

• The latest evidence from a large multicentric RCT did not support the use of graduated compression stockings to prevent post-thrombotic syndrome, and no evidence to support their use for treatment of the syndrome could be found [12] [21].

By compression level:

Table 2 summarizes the different types of compression stocking pressure levels and their indications.

Table 2: Compression stocking pressure levels and indications

Contraindications

Below is a summary of contraindications to compression therapies and gradient compression stockings. See more information on general contraindications for compression therapies (including gradient compression stockings) in “Compression Therapies for Venous Ulcers”, in section ‘Contraindications’.

General contraindications for compression therapies:

• Severe peripheral arterial disease
• Acute deep venous thrombosis
• Cellulitis
• Unstable congestive cardiac failure

Other contraindications related to compression stockings [12]:

• Allergy to stocking material
• Local skin or soft-tissue condition, including recent skin graft, fragile “tissue paper” skin, gangrene, oozing dermatitis and severe cellulitis
• Extreme deformity of the leg, or unusual leg shape or size preventing correct fit
• Highly exuding VLU is not a contraindication per se, however stockings may need to be washed constantly due to frequent soiling.

Evidence and Recommendations

Please see “Venous ulcers”, section on ‘Compression’ for rationales and summary of evidence supporting the recommendations below.

• 1B
  For VLU patients with no contraindications, we recommend compression over no compression therapy to promote wound healing (Grade 1B).
• 2B
  As for initial choice of compression therapy, we suggest multi-component compression bandages over single-component compression bandages (Grade 2B), and multi-component bandages with an elastic layer (e.g, 4LB) over those composed mainly of inelastic layers (e.g, SSB) (Grade 2B).
• 2B
  Two-layer gradient compression stockings (HH) that deliver 40 mmHg pressure at the ankle can be considered an effective alternative to multi-component compression systems (4LB) (Grade 2B).
• 2C
  Intermittent pneumatic compression (IPC) therapy can be used when all other compression therapy methods have failed or on patients that do not tolerate multi-component compression systems or high compression gradient stockings (Grade 2C).
• 2C
  To decrease risk of ulcer recurrence in patients with a healed VLU, we suggest compression therapy with gradient compression stockings at the highest pressure patients can tolerate (Grade 2C).

PracticE Tips

Risks and Complications

Most complications due to compression therapy are avoidable if appropriate measures to mitigate risks are taken. Before application of compression, clinicians should ensure patient does not have any contraindications. If however, the patient is a good candidate and complications still arise, it is important that they be addressed promptly. Complications may include pain, pressure damage, loss of calf muscle and skin problems. Please see more details in “Compression Therapy for Venous Ulcer”, section ‘Risks and Complications’

Prescription

Ready-to-wear and over the counter compression garments do not require a prescription when paid out-of-pocket. However, retailers may choose to require a prescription to ensure the product fits the patient’s needs. Custom products require a prescription and it is recommended that class III and IV be only prescribed by medical specialists. If patients are not adequately assessed, compression can impair proper blood circulation to lower extremities, which can be harmful especially in patients with peripheral artery disease or diabetes.

Prescriptions for gradient compression stockings need to indicate the type of stocking, length, compression level and number of units (frequency of use, expected duration of need are also needed for Medicare coverage). Measurements are needed for proper fitting (see measuring methods in ‘How to: selection, measurement and application methods’). Stockings should be replaced at least every 6 months, according to manufacturers’ instructions.

How to: selection, measurement and application(donning) methods

Selection of gradient compression stockings

• Gradient compressions stockings have several pressure levels and features. Appropriate selection of pressure levels, duration of treatment and features/characteristics is determined according to:
• The patient’s condition, preference and ability to tolerate compression
• The clinician’s preference and technical skills,
• Availability of resources
• See more information on features and characteristics of gradient compression stockings in ‘Different features of gradient compression stockings’; see more information on conditions and pressure levels in ‘Indications’

Measurement

• For proper fitting, limb diameter measurements are best taken by a trained healthcare professional right after the patient wakes up in the morning, when legs tend to be less swollen. If measurements cannot be made earlier in the day, an alternative is to elevate and bandage the legs so that the swelling subsides before measuring them. Measurements can also be taken by trained professionals at medical equipment stores that carry stockings.
• Best fit is usually achieved with custom-fitted stockings; measurement for custom-fitted stockings is generally done by trained professionals at medical equipment stores.
• As for semi-custom or off-the-shelf stockings, there is large variability among manufacturers’ sizing charts (e.g, a “medium” or “size 4” from two manufacturers may differ significantly), and as a result, measurement is crucial. However even with proper measurement, off-the-shelf stockings may not fit patients adequately [16]
• 3-point measurement method for semi-custom/ off-the-shelf knee-high stockings (Figure 3):
• • Measure the leg(s) with a tape measure (or a piece of string to determine the distance between points then measure the distance with a ruler)
  • Ankle circumference measurement: measure smallest circumference around ankle, usually around half an inch above lateral malleolus
  • Calf circumference measurement: find the widest part of the calf and measure circumference at this point
  • Calf length measurement: with patient seated, flex knee at 90 degrees relative to the floor and measure the distance between floor and half an inch below the popliteal crease

Figure 3. Three-point measurement method for knee-high compression stockings (left: ankle measurement, middle: calf measurement, right: length measurement)

Application (donning):

• For adequate compression, garments need to be used constantly when the patient is awake, and preferably applied before patient gets up in the morning. Figure 4 illustrates a technique to don stockings. Rubber gloves (Figure 5) and donning devices (Figure 6) can be used to facilitate donning. Donning devices significantly improve the ability of elderly patients to don compression stockings successfully [24]. Stockings with Velcro or zipper also help achieve a good fit (Figure 2).

Figure 4: Technique to don gradient compression stocking

Figure 5: Rubber gloves to help don compression stockings

Figure 6. Donning devices. Foot slips for stockings with open toe: (A) Easy Slide (SIGVARIS, Winterthur, Switzerland); (B) Veno Glider (SALZMANN MEDICO, St. Gallen, Switzerland); (C) Venotrain Foot Slip (Bauerfeind, Oberrohrdorf, Switzerland). Foot slips for stockings with closed toe: (D) Easy Slide Caran (SIGVARIS) and (E) Venotrain Glider (Bauerfeind). Frames for stockings with open and closed toe stockings respectively: (F) Socks Jet without handle (SALZMANN); (G) Socks Jet with handle (SALZMANN) and (H) Mediven Butler (MEDI, Bayreuth, Germany).

Patient Adherence

Compression is only effective if applied constantly, daily. Clinicians should keep in mind the high prevalence of patient adherence issues, which has been reported to be 30%–65% [12].

Among reasons for low adherence are difficulties in putting on and removing the garment, pain, discomfort, sensation of warmth and deterioration of pre-existing pruritus associated with venous eczema, cost and appearance [12][14]. If problems arise, clinicians should ask their patients why the stockings are not being used, because many of these factors are easily solved by simply changing the stocking material, lowering the degree of compression or providing adequate information and reassurance to patients [12].

PATIENT EDUCATION FOR CLINICIANS

VLU are a chronic, long-term problem, with recurrence rates are as high as 70%. Therefore, long-term maintenance must be addressed even for healed ulcers [8]. See “Venous Ulcers”, section on ‘Patient Education’ for details on patient education for VLU healing, prevention of new VLU and prevention of recurrence.

We recommend sharing our patient education materials with VLU patients (for all materials, see Patient Education Materials)

Gradient Compression Stocking Patient Education materials:

• Gradient Compression Stockings for Patients
  

Related Patient Education materials:

• Basic principles of wound care (handout)
• Chronic ulcers (handout)
• Compression therapy (handout)
• Debridement (handout)
• Nutrition (handout)
• Showering instructions (handout)
• Smoking cessation (handout)
• Ulcer infection (handout)

CODING, COVERAGE AND REIMBURSEMENT

This section currently focuses primarily on coverage of gradient compression stockings for VLU by Medicare. It may be expanded in the future to include information on private insurers as well. For guidance on coverage of gradient compression stockings for lymphedema, see topic "Expanding Care: Medicare's 2024 Coverage Update for Lymphedema Compression Treatment Items".

General

• Overall, compression bandages, wraps and certain gradient compression stockings are considered Surgical Dressings and covered by Medicare part B as long as used on patients with a venous stasis ulcer (VLU) that meet the requirements to be a qualified wound (surgically created or modified, or debrided). These items are only covered if used at the beneficiary's residence (place of service 12) and are not separately payable if items are supplied at physician's office or hospital outpatient department.
• Medicare coverage of compression devices, including compression bandages, is managed by Medicare Administrative Contractors (MAC). Coverage is explained by the:
• • Local Coverage Determination (LCD) Surgical Dressings (L33831) [25] , and
  • Local Coverage Article: Surgical Dressings - Policy Article (A52491) [26]. 
• The frequency of recommended dressing changes depends on the type and use of the surgical dressing. When combinations of primary dressings, secondary dressings, and wound filler are used, the change frequencies of the individual products should be similar. According to the Surgical Dressings Policy , the product in contact with the wound determines the change frequency. It is not reasonable and necessary to use a combination of products with differing change intervals. For example, it is not reasonable and necessary to use a secondary dressing with a weekly change frequency over a primary dressing with a daily change interval. Such claims will be denied as not reasonable and necessary.
• The following items are covered by Medicare Part B when requirements are met: 

30-40 or 40-50 mmHg below knee gradient compression stockings

• HCPCS: 
• • A6531- GRADIENT COMPRESSION STOCKING, BELOW KNEE, 30-40 MMHG, USED AS A SURGICAL DRESSING, EACH 
  • A6532 -GRADIENT COMPRESSION STOCKING, BELOW KNEE, 40-50 MMHG, USED AS A SURGICAL DRESSING, EACH
  • See non-covered and covered HCPCS in Table 3 below
• Coverage requirements:
• • The gradient compression stockings above are only covered when they are used as a primary or secondary dressing over wound that meet the statutory requirements for a qualifying wound (surgically created or modified, or debrided). Specifically, the patient needs to have an active venous ulcer that has been treated by a physician or other healthcare professional and that required medically necessary debridement.
  • Claims for gradient compression stockings used without a qualifying wound or when used for other non-qualifying conditions will be denied as statutorily non-covered, no benefit. Refer to the related Policy Article non-medical necessity coverage and payment rules for information about the statutory benefit requirements
• Frequency of replacement allowed by Medicare:
• • 1 unit per leg every 6 months.
    
• Non-covered conditions:
• • Venous insufficiency without stasis ulcers
  • Prevention of stasis ulcers
  • Prevention of the reoccurrence of stasis ulcers that have healed
  • Treatment of lymphedema in the absence of ulcers
  • Situations other than as a dressing for a qualified wound (VLU that has been debrided)
• Billing reminders:
• • Billable unit: For the compression stocking codes A6531 and A6532, one unit of service is generally for one stocking. However, if a manufacturer has a product consisting of two components which are designed to be worn simultaneously on the same leg (e.g., two-component gradient compression stocking or HH), the two components must be billed as one claim line with one unit of service – e.g., a product which consists of an unzippered liner and a zippered stocking.
  • When gradient compression stocking codes A6531 and A6532 or the gradient compression wrap code A6545 are used for an open venous ulcer, the code must be billed with the modifier AW. RT/LT modifiers need to be used to indicate side. Since stockings come in pairs, bill the left and the right stocking on the same claim line using the RT/LT modifiers and 2 units of service. Claims billed without modifiers AW or RT and/or LT will be rejected as incorrect coding. Modifiers A1-A9 are not used with codes A6531 and A6532.

HCPCS Modifiers 

• Modifiers A1-A9 are not used with codes A6531 and A6532.
• Claims for gradient compression stockings without the modifiers below will be rejected by the MAC.
• • AW - Item furnished in conjunction with a surgical dressing
  • RT – Right side
  • LT- Left side

Table 3 shows the classification of gradient compression stockings according to the Healthcare Common Procedure Coding System (HCPSC) adopted in the United States by Medicare and private insurers [25]. For more information on gradient compression wraps, see “ Static: Gradient Compression Wrap”. 

Table 3: Gradient compression stockings/wraps coded according to the Healthcare Common Procedure Coding System (HCPSC).

No* Gradient compression stockings (A6530, A6533, A6534, A6535, A6536, A6537, A6538, A6539, A6540, A6541, A6544, A6549) are non-covered under the surgical dressing benefit because they do not meet the statutory definition of a dressing; however, they may be considered for coverage under the lymphedema compression treatment items benefit and billed in accordance with CMS Final Rule CMS-1780-F [26]

Reimbursement

Billable gradient compression stockings and wraps for management of VLUs are eligible for reimbursement by Medicare part B. Items will be dispensed to patients through a durable medical equipment (DME) supplier, which will require a medical prescription and documentation.  This benefit is not payable through other care settings such as home health, hospital outpatient facilities, nursing homes, hospitals, physician’s office.

Table 4 shows sample data with the total highest and lowest amount Medicare will pay for each of the covered items (total allowable) and the highest and lowest patient co-payment amount. Amounts vary according to each MAC and state where item is being used, and are published regularly by Medicare under the DMEPOS Fee Schedule (refer to the most current data on the CMS website or WoundReference Product Navigator). [27][28]

Table 4: Total amount in US$ that Medicare part B covers for covered gradient compression stockings/ wraps and respective patient co-payment amounts. Refer to the most current data on the CMS website or WoundReference Product Navigator)

MEDICAL RECORDS DOCUMENTATION

• ICD-10 that support medical necessity:
• • I83.00-I83.02 Varicose veins of lower extremities with ulcer
  • I83.20-I83.22 Varicose veins of lower extremities with both ulcer and inflammation
• Documentation of wound(s): etiology, location, size, depth, tunneling/undermining, exudate/eschar characteristics, prior treatments. The wound needs to have been debrided by a physician or qualified healthcare professional (see debridement methods in “Venous Ulcer”, section on ‘Debridement’).
• Documentation on patient evaluation: must be performed at least once a month. If this frequency is not possible, there must be documentation which justifies why an evaluation could not be done within this timeframe and what other monitoring methods were used to evaluate the patient’s need for dressings. Evaluation is expected on a more frequent basis (e.g., weekly) in patients at a nursing facility or in patients with heavily draining or infected wounds. The evaluation may be performed by a nurse, physician or other health care professional.

COST-EFFECTIVENESS

Estimated Costs

Table 5 illustrates list prices, Medicare total allowable and patient co-payment of gradient compression stockings/wraps in 2017 US$. It is suggested that patients have at least a pair of stockings simultaneously, such that patients can continue to wear stockings when one pair is being washed.  

Table 5. List prices, Medicare total allowable and patient co-payment of different types of gradient compression stockings.

Compare prices of different brands with the Gradient compression stockings – Compare brands tool

Cost-Effectiveness Analysis (CEA)

Literature is scarce in studies that analyze cost-effectiveness of gradient compression stockings in VLU healing.

Data from a large randomized clinical trial (VenUS IV) published in 2014 found no evidence of a difference in venous ulcer healing between two-component gradient compression stockings (HH) and four-component bandages (4LB). The results also suggested that HH may reduce ulcer recurrence rates when compared with the 4LB and be a cost-effective treatment.  In an additional analysis, when all high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the quality of the underlying evidence was sparse and poor overall. All methods delivered high compression at 40 mmHg [3]. Table 6 summarizes findings of the cost-effectiveness analysis carried out in this study.

*In order to convert pounds to US$, the incremental cost in pounds 2014 was adjusted for inflation first and then converted to US$ in 2017

Table 6. Summary of the cost-effectiveness analysis performed by Ashby et al in 2014 (VenUS IV)

CMS QUALITY MEASURES

Below are measures that are directly related to compression therapy for VLU. For other measures related to VLU see “Venous Ulcers”, section ‘CMS Quality Measures’. For a comprehensive list of wound care related measures, see “Wound Care Quality Measures”.

MIPS currently does not have VLU-specific measures. Listed below are VLU/compression therapy-specific measures issued by the US Wound Registry.

MANUFACTURERS AND BRANDS

BSN Medical, Inc

• Jobst Opaque Knee High Compression Stockings
• Jobst Elvarex®
• JoViPak®
• UlcerCARE™

Carolon

• Health Support Knee Length
• Health Support Multi-layer stocking system

mediUSA

• Mediven® Dual Layer Stocking System

JUZO

• Juzo Basic
• Ulcer Pro

Medline Industries Inc

• Curad Compression Hosiery

Sigvaris

• Access
• Eversheer
  
• Natural Rubber