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DESCRIPTIONPatients undergoing major orthopedic surgery are at increased risk for venous thromboembolism (VTE). Patients undergoing other types of surgery may also be at increased risk of VTE. Limb compression devices are an option for thromboprophylaxis and are commonly used in the hospital setting. Outpatient use of compression devices following hospitalization, with or without pharmacologic prophylaxis, has also been proposed.
Patients undergoing major surgery are at increased risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE), together known as venous thromboembolism (VTE). Patients who are having major orthopedic surgery (defined here as total hip arthroplasty [THA], total knee arthroplasty [TKA] and hip fracture surgery [HFS]) are at particularly high risk. Risk of DVT is increased 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 an acute DVT is a 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 42-57% after total hip replacement, and the risk of pulmonary embolism is approximately 1-28%. Other surgical patients may also be at increased risk of VTE during and after hospitalization. For example, it is estimated that rates of VTE without prophylaxis after gynecologic surgery is about 15-40%.
Thus, antithrombotic prophylaxis is recommended for patients undergoing major orthopedic surgery and other surgical patients at increased risk of VTE. For patients undergoing major orthopedic surgery, clinical practice guidelines published in 2012 by the American College of Chest Physicians (ACCP) recommend that one of several pharmacologic agents or mechanical prophylaxis be provided rather than no thromboprophylaxis. The guidelines further recommend the 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 outpatient use.
The ACCP guidelines noted that compliance is a major issue with limb compression devices used for thromboprophylaxis and recommend that, if this prophylactic option is selected, use should be limited to portable, battery-operated devices. Moreover, it is recommended that devices be used for 18 hours per day. A 2009 non-randomized study found that there was better compliance with a portable battery-operated limb compression device compared to a non-mobile 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, the ACCP recommends prophylaxis with pharmacologic agents or intermittent pneumatic compression rather than no prophylaxis. For patients at low risk for VTE (about 1.5%), the guidelines suggest mechanical prophylaxis. Unlike the guidelines on major orthopedic surgery, which recommend a minimum of 10-14 days of VTE prophylaxis, the guideline on non-orthopedic surgery patients does 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 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 outpatient setting. However, especially with the availability of portable, battery-operated devices, there is interest in use of outpatient limb compression devices for DVT following discharge from the hospital for major orthopedic and non-orthopedic surgery.
Various pneumatic and peristaltic limb compression devices, with indications including prevention of DVT, have been cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process. 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.
POLICYOutpatient use of limb compression devices for venous thromboembolism prophylaxis after major orthopedic surgery may be considered medically necessary in patients with a contraindication to pharmacological agents i.e., at high-risk for bleeding.
Outpatient use of limb compression devices for venous thromboembolism prophylaxis after major non-orthopedic surgery or nonmajor orthopedic surgery may be considered medically necessary in patients who are at moderate or high risk of venous thromboembolism (see Policy Guidelines) with a contraindication to pharmacological agents i.e., at high-risk for bleeding.
Outpatient use of limb compression devices for venous thromboembolism prophylaxis after major orthopedic surgery is considered investigational in patients without a contraindication to pharmacological prophylaxis.
Outpatient use of limb compression devices for venous thromboembolism prophylaxis after major non-orthopedic surgery or nonmajor orthopedic surgery is considered investigational in patients who are at moderate or high risk of venous thromboembolism without a contraindication to pharmacological prophylaxis and in patients who are at low-risk of venous thromboembolism.
Outpatient use of limb compression devices for venous thromboembolism prophylaxis after all other surgeries is considered investigational.
Outpatient 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.
POLICY GUIDELINESFor purposes of this policy, “major orthopedic surgery” includes total hip arthroplasty, total knee arthroplasty, or hip fracture surgery.
Guidance on Determining High Risk for Bleeding
The ACCP guidelines on prevention of 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 (THA, TKA or HFS), 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 length of standard duration or “limited duration” 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 Risk Level for Patients Undergoing 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 at least 60 years, prior VTE, and cancer; age >60 years, prior VTE, anesthesia at least 2 h, and bed rest at least 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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 added.
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.