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Compression: Gradient compression stockings

Compression: Gradient compression stockings

Compression: Gradient compression stockings

SUMMARY

Background: 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]. Gradient compression stockings can be a viable first-line compression modality in the treatment of VLU, however not all patients are able to tolerate them [4].

Indications:

  • Healing of active VLU
  • Prevention of new or recurrent VLU
  • Spider veins and reticular varices (C1), varicose veins (C2), edema (C3) and skin changes (C4), with heavy, tired legs
  • Post-venous interventions
  • Deep vein thrombosis prophylaxis
  • Lymphedema
  • Superficial thrombophlebitis

Contraindications:

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

Evidence and Recommendations:

  • 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).

Coding, coverage and reimbursement

The gradient compression stockings below are covered by Medicare part B, as long as requirements are met.

Item

HCPCS II

Total allowable (ceiling/floor)

Patient co-payment (ceiling/floor)

Frequency of replacement

Gradient compression stocking, below knee, 30-40 mmHg, each

A6531

$48.16/$40.94

9.63/$8.19

1 unit per leg/6 months

Gradient compression stocking, below knee, 40-50 mmHg, each

A6532

$67.86/57.68

$13.57/$11.54

1 unit per leg/6 months

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

Not applicable or payable in other care settings such as hospital outpatient clinic, physician's office, home

health


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 Ulcer”). For a high-level overview on the general use of compression therapy for VLU, please see “Compression Therapy”. For more details on other compression therapy subtypes please see “Compression Bandages”, “Tubular Dressings (Bandages)”, “Gradient Compression Wraps” and “Dynamic or Intermittent Compression

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

    Classification

    Pressure (mmHg)

    Class I

    20-30

    Class II

    30-40

    Class III

    40-50


    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”, sectionVascular 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.

    Class

    Pressure at the ankle

    Beneficial to

    Over the counter

    Non-medical support hosiery

    < 15 mmHg

    Provide relief for heavy, tired legs – CEAP C0 [12]

    Gradient Compression Stocking 

    15-20 mmHg

    Relief of pain and improve in QoL in symptomatic patients with:

    Spider veins, reticular varices (C1)  [22]

    Gradient Compression Stocking Class I (U.S.)

    20-30 mmHg

    Symptomatic varicose veins (C2) [17]. If patient with varicose veins is candidate for saphenous vein ablation, compression should not be used as primary treatment [12] [17]

    Mild swelling (C3) Evidence wound

    Chronic venous disease with skin changes (C4) if patient does not tolerate higher pressure

    Prevention of recurrence of venous leg ulcer (C5) after superficial vein ablation or if patient not surgical candidate [14]

    Post vein ablation [23]

    Aseptic superficial thrombophlebitis [12]

    Gradient Compression Stocking Class II (U.S.)

    30-40 mmHg

    Chronic venous disease with skin changes (C4) [12]

    Prevention of recurrence of venous leg ulcer (C5) after superficial vein ablation or if patient not surgical candidate [14]

    Management of active venous leg ulcer (C6) [12] [17]

    Lymphedema [12]

    Gradient Compression Stocking Class III (U.S.)

    40-50 mmHg

    Severe lymphedema [12]

    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
    Care coordination
    • Many patients and/or clinicians may prefer to utilize other subtypes of compression therapy (bandages, wraps, etc) to promote VLU healing. However, gradient compression stockings are needed to prevent VLU recurrence. Because Medicare and most insurers cover gradient compression stockings only if an active VLU is present, clinicians can order gradient compression stockings (provided other Medicare requirements are met) while patient is still has an active VLU being treated with another type of compression. In that way, stockings can be covered by Medicare and patients can receive timely education on how to wear them as soon as VLU is healed

    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, Video 1) 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).

      Video 1: – Donning gradient compression stockings with donning aids

      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:

      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 Medicare. It may be expanded in the future to include information on private insurers as well.

      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 [2] , 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, EACH
        • A6532 -GRADIENT COMPRESSION STOCKING, BELOW KNEE, 40-50 MMHG, 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”.

      HCPCS

      Product Subtype

      Covered by Medicare

      A6530

      GRADIENT COMPRESSION STOCKING, BELOW KNEE, 18-30 MMHG, EACH

      No

      A6531

      GRADIENT COMPRESSION STOCKING, BELOW KNEE, 30-40 MMHG, EACH

      Yes, if requirements met*

      A6532

      GRADIENT COMPRESSION STOCKING, BELOW KNEE, 40-50 MMHG, EACH

      Yes, if requirements met*

      A6533

      GRADIENT COMPRESSION STOCKING, THIGH LENGTH, 18-30 MMHG, EACH

      No

      A6534

      GRADIENT COMPRESSION STOCKING, THIGH LENGTH, 30-40 MMHG, EACH

      No

      A6535

      GRADIENT COMPRESSION STOCKING, THIGH LENGTH, 40-50 MMHG, EACH

      No

      A6536

      GRADIENT COMPRESSION STOCKING, FULL LENGTH/CHAP STYLE, 18-30 MMHG, EACH

      No

      A6537

      GRADIENT COMPRESSION STOCKING, FULL LENGTH/CHAP STYLE, 30-40 MMHG, EACH

      No

      A6538

      GRADIENT COMPRESSION STOCKING, FULL LENGTH/CHAP STYLE, 40-50 MMHG, EACH

      No

      A6539

      GRADIENT COMPRESSION STOCKING, WAIST LENGTH, 18-30 MMHG, EACH

      No

      A6540

      GRADIENT COMPRESSION STOCKING, WAIST LENGTH, 30-40 MMHG, EACH

      No

      A6541

      GRADIENT COMPRESSION STOCKING, WAIST LENGTH, 40-50 MMHG, EACH

      No

      A6544

      GRADIENT COMPRESSION STOCKING, GARTER BELT

      No

      A6545

      GRADIENT COMPRESSION WRAP, NON-ELASTIC, BELOW KNEE, 30-50 MM HG, EACH

      Yes, if requirements met*

      A6549

      GRADIENT COMPRESSION STOCKING/SLEEVE, NOT OTHERWISE SPECIFIED

      No

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

        Reimbursement

        Billable gradient compression stockings and wraps 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 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 [27] [28]


        HCPCS

        Product Subtype

        Total allowable (US$)

        Patient co-payment (US$)

        ceiling

        floor

        ceiling

        floor

        A6531

        GRADIENT COMPRESSION STOCKING, BELOW KNEE, 30-40 MMHG, EACH

        48.16

        40.94

        9.63

        8.19

        A6532

        GRADIENT COMPRESSION STOCKING, BELOW KNEE, 40-50 MMHG, EACH

        67.86

        57.68

        13.57

        11.54

        A6545

        GRADIENT COMPRESSION WRAP, NON-ELASTIC, BELOW KNEE, 30-50 MM HG, EACH

        94.83

        80.61

        18.97

        16.12

        Table 4: Total amount in US$ that Medicare part B covers for covered gradient compression stockings/ wraps and respective patient co-payment amounts. Data extracted from the most current Medicare DMEPOS Fee Schedule

        MEDICAL RECORDS DOCUMENTATION

        To justify medical need of graduated compression stockings, MACs require that the patient’s medical records contain the following type of information:

        • 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.  

        Type of compression stocking (pressure level)

        Approximate list price/ pair

        US$

        Medicare Total Allowable

        Medicare patient co-payment

        Ceiling

        Floor

        Ceiling

        Floor

        Over the counter (< 15 mm Hg)

        10-30

        N/A

        Off the shelf graduated medical compression stocking (18-30 mmHg)

        10-50

        N/A

        Off the shelf graduated medical compression stocking (30-40 mmHg)

        20-100

        48.16

        40.94

        9.63

        8.19

        Off the shelf graduated medical compression stocking (40-50 mmHg)

        60-100

        67.86

        57.68

        13.57

        11.54

        Custom graduated medical compression stocking (any)

        200-500

        N/A

        Double layer (40 mmHg) E.g, Jobst Ulcer Care, Carolon Multi-layer compression system, Mediven Ulcer Kit, Activa leg ulcer

        80-100

        N/A

        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.

          Authors, year

          Ashby et al, 2014 [3]

          Population

          patients with (one or more) venous leg ulcers in the United Kingdom (UK)

          Intervention

          2LB

          Comparator

          HH, 4LB, SSB, Paste

          Outcome

          Healing of VLU

          ICER summary/estimate (2017 US$)

          Dominant

          Incremental cost

          UK pounds, 2014 = 16,174.0 * / US$, 2017 =22,018.63

          Incremental effectiveness

          3.8595

          Comments

          data on 2LB effectiveness is of low quality, therefore the cost-effectiveness results need to be interpreted with caution. In an alternative scenario that assumes that effectiveness of 2LB is similar to that of 4LB, HH was shown to be the most cost-effective intervention

          *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.

          QCDR

          Title

          Description

          ID

          Measure Type

          US Wound Registry (USWR)

          Adequate Compression at each visit for Patients with VLUs

          Percentage of venous leg ulcer visits of patients aged 18 years and older that received adequate compression within the 12-month reporting period.

          5

          Process

          MANUFACTURERS AND BRANDS

          BSN Medical, Inc

          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
          Official reprint from WoundReference® woundreference.com ©2018 Wound Reference, Inc. All Rights Reserved
          Use of WoundReference is subject to the Subscription and License Agreement. ​
          NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

          REFERENCES

          1. World Union of Wound Healing Societies (WUWHS), et al. Principles of best practice: Compression in venous leg ulcers. A consensus document. . Date of publication 2017;.
          2. Kirsner, Robert S; Margolis, David J et al. Stockings before bandages: an option for venous ulcers. The Lancet. Date of publication 2014;volume 383(9920):850-851.
          3. Ashby, Rebecca L; Gabe, Rhian; Ali, Shehzad; Saramago, Pedro; Chuang, Ling-Hsiang; Adderley, Una; Bland, J Martin; Cullum, Nicky A; Dumville, Jo C; Iglesias, Cynthia P; Kang'ombe, Arthur R; ... et al. VenUS IV (Venous leg Ulcer Study IV) - compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decision-analytic model. Health Technology Assessment. Date of publication 2014;volume 18(57):1-293, v.
          4. O'Donnell, Thomas F; Passman, Marc A; Marston, William A; Ennis, William J; Dalsing, Michael; Kistner, Robert L; Lurie, Fedor; Henke, Peter K; Gloviczki, Monika L; Eklöf, Bo G; Stoughton, Ju... et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery ® and the American Venous Forum. Journal of Vascular Surgery. Date of publication 2014;volume 60(2 Suppl):3S-59S.
          5. O'Meara, Susan; Cullum, Nicky; Nelson, E Andrea; Dumville, Jo C et al. Compression for venous leg ulcers. Cochrane Database of Systematic Reviews. Date of publication 2012;volume 11():CD000265.
          6. Kirsner, Robert S et al. Compression of venous ulcers: standardizing standard care. JAMA dermatology. Date of publication 2014;volume 150(7):736-737.
          7. Ashby, Rebecca L; Gabe, Rhian; Ali, Shehzad; Adderley, Una; Bland, J Martin; Cullum, Nicky A; Dumville, Jo C; Iglesias, Cynthia P; Kang'ombe, Arthur R; Soares, Marta O; Stubbs, Nikki C; Torg... et al. Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. The Lancet. Date of publication 2014;volume 383(9920):871-879.
          8. Marston, William; Tang, Jennifer; Kirsner, Robert S; Ennis, William et al. Wound Healing Society 2015 update on guidelines for venous ulcers. Wound Repair and Regeneration. Date of publication 2016;volume 24(1):136-144.
          9. Couch KS, Corbett L, Gould L, Girolami S, Bolton L et al. The International Consolidated Venous Ulcer Guideline Update (2015): Process Improvement, Evidence Analysis, and Future Goals. Ostomy/wound management. Date of publication 2017;volume 63(5):42-46.
          10. O'Donnell, Thomas F; Balk, Ethan M et al. The need for an Intersociety Consensus Guideline for venous ulcer. Journal of Vascular Surgery. Date of publication 2011;volume 54(6 Suppl):83S-90S.
          11. Raju, Seshadri; Hollis, Kathryn; Neglen, Peter et al. Use of compression stockings in chronic venous disease: patient compliance and efficacy. Annals of Vascular Surgery. Date of publication 2007;volume 21(6):790-795.
          12. Lim, Chung Sim; Davies, Alun H et al. Graduated compression stockings. Canadian Medical Association Journal. Date of publication 2014;volume 186(10):E391-8.
          13. Moffat, C et al. Compression therapy in practice . Date of publication 2017;.
          14. Wittens, C; Davies, A H; Bækgaard, N; Broholm, R; Cavezzi, A; Chastanet, S; de Wolf, M; Eggen, C; Giannoukas, A; Gohel, M; Kakkos, S; Lawson, J; Noppeney, T; Onida, S; Pittaluga, P; Thomis, ... et al. Editor's Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). European Journal of Vascular and Endovascular.... Date of publication 2015;volume 49(6):678-737.
          15. Harding, Keith; Dowsett, Caroline; Fias, Lore; et, al et al. Simplifying venous leg ulcer management. Consensus recommendations. . Date of publication 2017;.
          16. Nørregaard, S; Bermark, S; Gottrup, F et al. Do ready-made compression stockings fit the anatomy of the venous leg ulcer patient? Journal of Wound Care. Date of publication 2014;volume 23(3):128, 130-2,134.
          17. Gloviczki, Peter; Comerota, Anthony J; Dalsing, Michael C; Eklof, Bo G; Gillespie, David L; Gloviczki, Monika L; Lohr, Joann M; McLafferty, Robert B; Meissner, Mark H; Murad, M Hassan; Padbe... et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. Journal of Vascular Surgery. Date of publication 2011;volume 53(5 Suppl):2S-48S.
          18. Shingler, Sarah; Robertson, Lindsay; Boghossian, Sheila; Stewart, Marlene et al. Compression stockings for the initial treatment of varicose veins in patients without venous ulceration. Cochrane Database of Systematic Reviews. Date of publication 2013;.
          19. Kern, Philippe; Ramelet, Albert-Adrien; Wütschert, Robert; Hayoz, Daniel et al. Compression after sclerotherapy for telangiectasias and reticular leg veins: a randomized controlled study. Journal of Vascular Surgery. Date of publication 2007;volume 45(6):1212-1216.
          20. Scott, Gemma; Mahdi, Ali Jassem; Alikhan, Raza et al. Superficial vein thrombosis: a current approach to management. British Journal of Haematology. Date of publication 2015;volume 168(5):639-645.
          21. Jin, Y W; Ye, H; Li, F Y; Xiong, X Z; Cheng, N S et al. Compression Stockings for Prevention of Postthrombotic Syndrome: A Systematic Review and Meta-Analysis. Vascular and endovascular surgery. Date of publication 2016;volume 50(5):328-334.
          22. Amsler, F; Blättler, W et al. Compression therapy for occupational leg symptoms and chronic venous disorders - a meta-analysis of randomised controlled trials. European Journal of Vascular and Endovascular.... Date of publication 2008;volume 35(3):366-372.
          23. Mariani, Fabrizio; Marone, Enrico Maria; Gasbarro, Vincenzo; Bucalossi, Matteo; Spelta, Sara; Amsler, Felix; Agnati, Michele; Chiesa, Roberto et al. Multicenter randomized trial comparing compression with elastic stocking versus bandage after surgery for varicose veins. Journal of Vascular Surgery. Date of publication 2011;volume 53(1):115-122.
          24. Sippel, K; Seifert, B; Hafner, J et al. Donning devices (foot slips and frames) enable elderly people with severe chronic venous insufficiency to put on compression stockings. European Journal of Vascular and Endovascular.... Date of publication 2015;volume 49(2):221-229.
          25. Center for Medicare and Medicaid Services (CMS), et al. Local Coverage Determination for Surgical Dressings (L33831) . Date of publication 2017;.
          26. Centers for Medicare and Medicaid Services, et al. Local Coverage Article for Surgical Dressings - Policy Article (A54563) . Date of publication 2015;.
          27. Centers for Medicare & Medicaid Services, et al. Durable Medical Equipment, Prosthetics/Orthotics, and Supplies Fee Schedule: DME fee schedule 2017-A . Date of publication 2017;.
          28. Centers for Medicare & Medicaid Services, et al. Durable Medical Equipment, Prosthetics/Orthotics, and Supplies Fee Schedule: DME fee schedule 2017-A: DME17-B . Date of publication 2017;.
          Topic 31 Version 1.0

          SUBTOPICS