Postsurgical Home Use of Limb Compression Devices for Venous Thromboembolism Prophylaxis

POLICY NUMBER

A.1.01.28

DESCRIPTION

Antithrombotic prophylaxis is recommended for surgical individuals at moderate-to-high risk of postoperative venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), based on the surgical procedure and/or individual characteristics. For some types of surgery (eg, major orthopedic surgery), there is a particularly high risk of VTE due to the nature of the procedure and the prolonged immobility during and after surgery. Common individual risk factors include increasing age, prior VTE, malignancy, pregnancy, and significant comorbidities. Increased risk of bleeding is a contraindication to anticoagulation, as are adverse events and allergic reactions. Limb compression devices have been used as an adjunct or alternative to anticoagulation in the home setting for individuals in the postoperative period as a method to reduce VTEs.

Risk of Venous Thromboembolism

Orthopedic Surgery

Antithrombotic prophylaxis is recommended for surgical individuals at moderate-to-high risk of postoperative venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). Individuals may be classified as moderate-to-high risk VTE based on the surgical procedure and/or individual characteristics. For some types of surgery, such as major orthopedic surgery, there is a particularly high risk of VTE due to the nature of the procedure and the prolonged immobility during and after surgery. The specific orthopedic procedures of concern are total knee arthroplasty, total hip arthroplasty, and hip fracture surgery. For these surgeries, all patients undergoing the procedure are considered at high-risk for VTE.

Other surgeries with an increased risk of VTE include abdominal surgery, pelvic surgery, cancer surgery, and surgery for major trauma. For these types of surgeries, the risk varies. There are numerous individual-related risk factors such as increasing age, prior VTE, malignancy, pregnancy, and significant comorbidities that can be used in conjunction with the type of surgery to determine risk. There are tools for assessing VTE risk in surgical individuals, such as the modified Caprini Risk Assessment Model used in developing the 2012 American College of Chest Physicians (ACCP) guidelines on VTE prevention. However, in clinical practice, this and similar instruments are not regarded as definitive for the assessment of individual risk. Pharmacologic prophylaxis is indicated for individuals at moderate-to-high risk for VTE. As described in the ACCP guidelines, there are preferred antithrombotic prophylaxis regimens according to procedure and individual risk characteristics.

Pharmacologic Prophylaxis

Pharmacologic prophylaxis is effective at reducing postoperative VTE, but also has risks. The main risk is bleeding, although other adverse events such as allergic reactions and development of heparin antibodies can occur. Contraindications to pharmacologic prophylaxis include previous intolerance to these agents and increased risk of bleeding. Most individuals undergoing major surgery will not have an increased risk of bleeding precluding the use of anticoagulants, because these individuals would also likely have had a contraindication to the surgery itself and, thus, are likely to avoid the procedure. However, there are some cases in which individuals with a high bleeding risk will undergo major surgery, such as individuals with severe renal failure who require an essential procedure. Other individuals may develop contraindications during the episode of care. For example, individuals who have excessive bleeding during or after surgery, or individuals who develop bleeding complications such as a gastrointestinal bleed, are considered to have a contraindication to anticoagulants. There are a few surgeries for which anticoagulants are contraindicated or avoided, most notably some neurosurgical procedures. Assessment and quantitation of bleeding risk can be performed using instruments such as the HAS-BLED scoring system, although these tools were not developed specifically for the postoperative period.

Major orthopedic surgeries have a high risk of DVT due to venous stasis of the lower limbs as a consequence of immobility during and after surgery. Also, direct venous wall damage associated with the surgical procedure itself may occur. DVTs are frequently asymptomatic and generally resolve when mobility is restored. However, some episodes of acute DVT can be associated with substantial morbidity and mortality. The most serious adverse consequence of acute DVT is PE, which can be fatal. Pulmonary embolism occurs when a DVT blood clot detaches and migrates to the lungs. Also, DVT may produce long-term vascular damage that leads to chronic venous insufficiency. Without thromboprophylaxis, the incidence of venographically detected DVT is approximately 42% to 57% after total hip replacement, and the risk of PE is approximately 1% to 28%. Other surgical individuals may be at increased risk of VTE during and after hospitalization. For example, it is estimated that rates of VTE without prophylaxis after gynecologic surgery are 15% to 40%.

Thus, antithrombotic prophylaxis is recommended for individuals undergoing major orthopedic surgery and other surgical procedures who are at increased risk of VTE. For individuals undergoing major orthopedic surgery, 2012 clinical practice guidelines published by the ACCP recommended that one of several pharmacologic agents or mechanical prophylaxis be provided rather than no thromboprophylaxis. The guidelines further recommended the use of pharmacologic prophylaxis during hospitalization, whether or not individuals are using a limb compression device. A minimum of 10 to 14 days of prophylaxis is recommended, a portion of which can be post-discharge home use.

Limb Compression Prophylaxis

The ACCP guidelines have also noted that compliance is a major issue with the home use of limb compression devices for thromboprophylaxis and recommended that, if this prophylactic option is selected, use should be limited to portable, battery-operated devices. Moreover, ACCP recommended that devices be used for 18 hours a day. A 2009 nonrandomized study found that there was better compliance with a portable battery-operated limb compression device than with a nonmobile device when used by individuals in the hospital following hip or knee replacement surgery.

Nonorthopedic Surgery

Pharmacologic and Limb Compression Prophylaxis

The ACCP also issued guidelines on VTE prophylaxis in non-orthopedic surgery individuals. For individuals undergoing general or abdominal-pelvic surgery who have a risk of VTE of 3% or higher, the ACCP has recommended prophylaxis with pharmacologic agents or intermittent pneumatic compression rather than no prophylaxis. For individuals at low risk for VTE (approximately 1.5%), the guidelines have suggested mechanical prophylaxis. Unlike the guidelines on major orthopedic surgery, which recommend a minimum of 10 to 14 days of VTE prophylaxis, the guidelines on non-orthopedic surgery individuals do not include a general timeframe for prophylaxis. They have, however, defined “extended duration” pharmacologic prophylaxis as lasting 4 weeks; the latter is recommended only for individuals at high risk for VTE, undergoing abdominal or pelvic surgery for cancer, and who are not otherwise at high risk for major bleeding complications.

National clinical guidelines have not specifically recommended the use of limb compression devices in the post-discharge home setting. However, given the availability of portable, battery-operated devices, there is interest in the home use of limb compression devices for VTE prevention following discharge from the hospital for major orthopedic and nonorthopedic surgery.

A large number of pneumatic and peristaltic limb compression devices have been cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process for indications including prevention of deep vein thrombosis. A sample of portable devices cleared by the FDA include:

• AIROS 6 Sequential Compression Device (AIROS Medical, Inc.): This device is safe for both home and hospital use.

• Plexus RP100 Disposable Portable Deep Vein Thrombosis Prevention Device (Alleva Medical [D.G.]) Ltd:

  This device is for home or clinical settings and is powered by an internal rechargeable battery.

• AeroDVxTM System (Sun Scientific Inc.): This device is for hospital or outpatient use.

• VenaPro™ Vascular Therapy System (InnovaMed Health): This device is battery-powered.

• Venowave™ VW5 (Venowave): This device is battery-powered and strapped to the leg below the knee.

• ActiveCare®+S.F.T. System (Medical Compression Systems): The device applies sequential pneumatic compression to the lower limb; it has the option of being battery-operated. Foot compression is achieved with the use of a single-celled foot sleeve. Calf and thigh compression requires the use of a 3-celled cuff sleeve.

• Restep® DVT System (Stortford Medical): This lightweight device uses single-chamber pressure cuffs attached to the individual's lower legs.

• Kendall SCD™ 700 Sequential Compression System (Covidien): This pneumatic compression device can be used in the clinic or at home. It has a battery-powered option.

• PlasmaFlow™ (ManaMed): This system is portable, to be used at home or in a clinical setting.

A full listing of products cleared by the FDA can be found at the following link: 510(k) Premarket Notification (fda.gov)

A related medical policy is Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers.

POLICY

Postsurgical home use of limb compression devices for venous thromboembolism (VTE) prophylaxis may be considered medically necessary in individuals with a contraindication to pharmacologic agents (see Policy Guidelines), in the following situations:

• After major orthopedic surgery (total hip arthroplasty, total knee arthroplasty, hip fracture surgery); OR

• After major nonorthopedic surgery or other orthopedic procedures in individuals who are at moderate or high risk of VTE (see Policy Guidelines).

Postsurgical home use of limb compression devices for venous thromboembolism prophylaxis is considered investigational in all other situations, including but not limited to:

• After major orthopedic surgery (total hip arthroplasty, total knee arthroplasty, hip fracture surgery) in individuals without a contraindication for anticoagulation; OR

• After major non-orthopedic surgery or other orthopedic procedures in individuals without a contraindication for anticoagulation who are at moderate or high risk of venous thromboembolism (see Policy Guidelines).

Postsurgical home use of limb compression devices for venous thromboembolism prophylaxis for periods longer than 30 days post-surgery is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

This section reviews guidance on contraindications to using anticoagulants, determining risk for bleeding, determining risk for venous thromboembolism (VTE), and duration of treatment postoperatively.

Contraindications to Anticoagulants

The main contraindication to anticoagulants is a high risk of bleeding. However, there is no absolute threshold at which anticoagulants cannot be used. Rather, there is a risk-benefit continuum that takes into account the benefits of treatment and risks of bleeding. There may also be intolerance to specific agents, although uncommon. Intolerance may result from allergic reactions or adverse events. Finally, when heparin preparations are used, serum antibodies and heparin-induced thrombocytosis can develop, precluding further use of heparin products.

Guidance on Determining High Risk for Bleeding

The American College of Chest Physicians (ACCP) guidelines on prevention of venous thromboembolism (VTE) in orthopedic surgery individuals listed the following general risk factors for bleeding:

• "Previous major bleeding (and previous bleeding risk similar to current risk)

• Severe renal failure

• Concomitant antiplatelet agent

• Surgical factors: a history of or difficult-to-control surgical bleeding during the current operative procedure, extensive surgical dissection, and revision surgery."

The guidelines indicated, however, that “...specific thresholds for using mechanical compression devices or no prophylaxis instead of anticoagulant thromboprophylaxis have not been established.”

The 2016 ACCP guidelines addressing antithrombotic therapy for VTE disease outlined risk factors for bleeding with anticoagulant therapy and estimated the risks of major bleeding for individuals in various risk categories (see Table 1).

Risk factors include (1 point per risk factor):

• “Age >65 y

• Age >75y

• Previous bleeding

• Cancer

• Metastatic cancer

• Renal failure

• Liver failure

• Thrombocytopenia

• Previous stroke

• Diabetes

• Anemia

• Antiplatelet therapy

• Poor anticoagulant control

• Comorbidity and reduced functional capacity

• Recent surgery

• Alcohol abuse

• Nonsteroidal anti-inflammatory drug.”

Table 1. Guidelines for Risk of Bleeding

Clinical guidelines from the American Academy of Orthopaedic Surgeons (AAOS) have indicated that:

"Patients undergoing elective hip or knee arthroplasty are at risk for bleeding and bleeding-associated complications. In the absence of reliable evidence, it is the opinion of this work group that patients be assessed for known bleeding disorders like hemophilia and for the presence of active liver disease which further increase the risk for bleeding and bleeding-associated complications. (Grade of Recommendation: Consensus) Current evidence is not clear about whether factors other than the presence of a known bleeding disorder or active liver disease increase the chance of bleeding in these patients and, therefore, the work group is unable to recommend for or against using them to assess a patient's risk of bleeding. (Grade of Recommendation: Inconclusive)"

Guidance on Duration of Use

In individuals with contraindications to pharmacologic prophylaxis who are undergoing major orthopedic surgery (total hip arthroplasty, total knee arthroplasty, hip fracture surgery), the ACCP guidelines are consistent with use of intermittent limb compression devices for 10 to 14 days after surgery. The ACCP suggestion on extended prophylaxis (up to 35 days) was a weak recommendation that did not mention limb compression devices as an option.

In the ACCP guidelines on VTE prophylaxis in individuals undergoing nonorthopedic surgery, the standard duration or “limited duration” of prophylaxis was not defined. However, “extended duration” pharmacologic prophylaxis was defined as 4 weeks, which was recommended only for individuals at high risk for VTE undergoing abdominal or pelvic surgery for cancer and not otherwise at high risk for major bleeding complications.

Guidance on Determining Risk Level for Nonorthopedic Surgery

The ACCP guidelines on prevention of VTE in nonorthopedic surgery individuals included the following discussion of risk levels:

“In patients undergoing general and abdominal-pelvic surgery, the risk of VTE varies depending on both patient-specific and procedure-specific factors. Examples of relatively low-risk procedures include laparoscopic cholecystectomy, appendectomy, transurethral prostatectomy, inguinal herniorrhaphy, and unilateral or bilateral mastectomy. Open-abdominal and open-pelvic procedures are associated with a higher risk of VTE. VTE risk appears to be highest for patients undergoing abdominal or pelvic surgery for cancer....

Patient-specific factors also determine the risk of VTE, as demonstrated in several relatively large studies of VTE in mixed surgical populations. Independent risk factors in these studies include: age >60 years, prior VTE, and cancer; age ≥60 years, prior VTE, anesthesia ≥2 h, and bed rest ≥4 days; older age, male sex, longer length of hospital stay, and higher Charlson comorbidity score; and sepsis, pregnancy or postpartum state, central venous access, malignancy, prior VTE, and inpatient hospital stay more than 2 days. In another study, most of the moderate to strong independent risk factors for VTE were surgical complications, including urinary tract infection, acute renal insufficiency, postoperative transfusion, perioperative myocardial infarction, and pneumonia.“

The American College of Obstetricians and Gynecologists use the Caprini Risk Assessment Model to determine VTE risk level in individuals undergoing major gynecology surgery (see Table 2); this tool was used in developing the ACCP guidelines on VTE prevention. Caprini scores of 1 to 2, 3 to 4, and 5 or higher indicate a low (1.5%), moderate (~3%), and high (~6%) risk of symptomatic VTE, respectively. The Caprini score is extensively used and has been validated in plastic surgery individuals and general surgery individuals, and the ACCP has defined each of these risk groups by the expected rate of VTE in a population of individuals undergoing general, abdominal-pelvic, bariatric, vascular, and plastic surgery without thromboprophylaxis.

Table 2. Caprini Score to Assess Risk of Venous Thromboembolism

BMI: body mass index; VTE: venous thromboembolism.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

03/21/2013: Approved by Medical Policy Advisory Committee.

04/07/2014: Policy title changed from "Outpatient Use of Limb Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis" to "Postsurgical Outpatient Use of Limb Compression Devices for Venous Thromboembolism Prophylaxis." Policy description updated regarding FDA approval of available devices. Removed "pneumatic" from policy statements. Added "or nonmajor orthopedic surgery" to the second and fourth policy statements.

01/15/2015: Policy description and guidelines updated to change "pneumatic" compression devices to "limb" compression devices. Policy statements unchanged.

08/31/2015: Medical policy revised to add ICD-10 codes.

04/26/2016: Policy Guidelines updated to add medically necessary and investigative definitions.

05/31/2016: Policy number A.1.01.28 added.

07/05/2016: Policy title changed from "Postsurgical Outpatient Use of Limb Compression Devices for Venous Thromboembolism Prophylaxis" to "Postsurgical Home Use of Limb Compression Devices for Venous Thromboembolism Prophylaxis." Policy description revised for clarity. Policy statements revised to change "outpatient use" to "postsurgical home use." Medically necessary policy statements revised for clarity; intent unchanged. Investigational policy statements revised for clarity; intent unchanged. Policy Guidelines updated regarding contraindications to anticoagulants.

03/23/2017: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines updated regarding ACCP guidelines for risk of bleeding with anticoagulant therapy.

04/02/2018: Policy description updated regarding devices. Policy statements unchanged.

04/03/2019: Policy reviewed; no changes.

04/14/2020: Policy description updated regarding devices. Policy statements unchanged.

05/24/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

04/27/2022: Policy description updated regarding patients at risk of postoperative venous thromboembolism. Updated link for list of products cleared by the FDA. Policy statements unchanged.

04/12/2023: Policy reviewed. Policy statements updated to change "patients" to "individuals" and "not medically necessary" to "investigational." Policy Guidelines updated regarding the Caprini Risk Assessment Model to determine venous thromboembolism risk level in patients undergoing major gynecology surgery.

04/12/2024: Policy description and Policy Guidelines updated to change "patients" to "individuals." Policy statements unchanged.

04/15/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 1.01.28

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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