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Antithrombotic prophylaxis is recommended for surgical patients who are at moderate-to-high risk of postoperative venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients may be classified as moderate-to-high risk of VTE based on the surgical procedure and/or patient 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 that have increased risk of VTE include abdominal surgery, pelvic surgery, cancer surgery, and surgery for major trauma. For these types of surgeries, the risk is variable. There are numerous patient-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 patients, such as the modified Caprini Risk Assessment Model that was used in developing the American College of Chest Physicians (ACCP) guidelines on VTE prevention. However, in clinical practice, this and similar instruments are not regarded as definitive for assessment of individual patient risk. Pharmacologic prophylaxis is indicated for patients at moderate-to-high risk for VTE. As described in the ACCP guidelines, there are preferred antithrombotic prophylaxis regimens according to procedure and patient risk characteristics.
Pharmacologic prophylaxis is effective at reducing postoperative VTE, but also has risks. The main risk is bleeding, although other adverse effects 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 patients undergoing major surgery will not have an increased risk of bleeding precluding use of anticoagulants, because these patients 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 patients with a high bleeding risk will undergo major surgery, such as patients with severe renal failure who require an essential procedure. Other patients may develop contraindications during the episode of care. For example, patients who have excessive bleeding during or after surgery, or patients who develop bleeding complications such as a gastrointestinal bleed, will subsequently have a contraindication to anticoagulants. There are a few surgeries for which anticoagulants are contraindicated or avoided, most notably some neurosurgery procedures. Assessment and quantitation of bleeding risk can be performed using instruments such as HAS-BLED scoring system, although these tools were not developed specifically for the postoperative period.
Major orthopedic surgeries have high risk of DVT due to venous stasis of the lower limbs as a consequence of immobility during and after surgery. In addition, 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; this occurs when the DVT detaches and migrates to the lungs. In addition, 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 patients 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 patients undergoing major orthopedic surgery and other surgical procedures who are at increased risk of VTE. For patients undergoing major orthopedic surgery, 2012 clinical practice guidelines published by ACCP recommended that one of several pharmacologic agents or mechanical prophylaxis be provided rather than no thromboprophylaxis. The guidelines further recommend use of pharmacologic prophylaxis during hospitalization, whether or not patients are using a limb compression device. A minimum of 10 to 14 days of prophylaxis is recommended, a portion of which can be postdischarge home use.
The ACCP guidelines noted that compliance is a major issue with home use of limb compression devices for thromboprophylaxis and recommend 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 patients in the hospital following hip or knee replacement surgery.
ACCP also issued guidelines on VTE prophylaxis in non-orthopedic surgery patients. For patients undergoing general or abdominal-pelvic surgery who have a risk of VTE of 3% or higher, ACCP recommends prophylaxis with pharmacologic agents or intermittent pneumatic compression rather than no prophylaxis. For patients at low risk for VTE (approximately 1.5%), the guidelines suggest 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 patients do not include a general timeframe for prophylaxis. They do, however, define “extended duration” pharmacologic prophylaxis as lasting 4 weeks; the latter is recommended only for patients 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 use of limb compression devices in the postdischarge home setting. However, given the availability of portable, battery-operated devices, there is interest in home use of limb compression devices for VTE prevention following discharge from the hospital for major orthopedic and nonorthopedic surgery.
Various pneumatic and peristaltic limb compression devices have been approved by the Food and Drug Administration (FDA) through the premarket approval process for indications including prevention of deep vein thrombosis. Portable devices that have been cleared by the FDA include:
A related medical policy is Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers.
Postsurgical home use of limb compression devices for venous thromboembolism (VTE) prophylaxis may be considered medically necessary in patients with a contraindication to pharmacologic agents (see Policy Guidelines), in the following situations:
Postsurgical home use of limb compression devices for venous thromboembolism prophylaxis is considered investigational in all other situations, including but not limited to:
Postsurgical home use of limb compression devices for venous thromboembolism prophylaxis for periods longer than 30 days post-surgery is not medically necessary.
POLICY EXCEPTIONSFederal 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.
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 use of 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 benefits of treatment and risks of bleeding. There may also be intolerance to specific agents, although this is uncommon. Intolerance may result from allergic reactions or adverse effects. 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 patients list the following general risk factors for bleeding:
The guidelines note, however, that “...specific thresholds for using mechanical compression devices or no prophylaxis instead of anticoagulant thromboprophylaxis have not been established.”
A clinical guideline from the American Academy of Orthopaedic Surgeons (2011) states:
Guidance on Duration of Use
In patients 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 10-14 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 guideline on VTE prophylaxis in patients undergoing non-orthopedic surgery, the standard duration or “limited duration” of prophylaxis was not defined. However, “extended duration” pharmacologic prophylaxis was defined as 4 weeks; this was recommended only for patients 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 Non-orthopedic Surgery
The ACCP guidelines on prevention of VTE in non-orthopedic surgery patients 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 (ACOG) proposed the following risk classification for VTE in patients undergoing major gynecological surgery:
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 Nervous/Mental Conditions, 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 Medically Necessary, “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 HISTORY03/21/2013: 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 1.01.28
CODE REFERENCEThis 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.
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