National Medical Policy

Transcription

1 National Medical Policy Subject: Policy Number: Pneumatic Compression Device (PCD) Post Surgery NMP524 Effective Date*: September 2013 Updated: September 2017 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies guidelines The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Pneumatic Compression Devices (280.6): X Local Coverage Determination (LCD)* Pneumatic Compression Devices: x Article (Local)* Pneumatic Compression Devices. Effective October 2014: x Other MLN Matters Number: MM8304 Revised. Implementation Date: July 1, Detailed Written Orders and Face-to-Face Encounters: Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/MM8304.pdf MLN Matters Number: MM5571 Revised. July 2, New Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFS) for Claims Penumatic Compression Post Surgery Sep 17 1

2 Processing: Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/MM5571.pdf None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion; an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Refer to the HN NMP on Lymphedema and Venous Stasis Ulcer Treatments Health Net, Inc. considers pneumatic compression devices (PCDs)* medically necessary in the following situations: 1. Post-operative scenarios, (i.e., following hip, knee, neurosurgery, or major surgical procedure, for which PCDs would be considered appropriate treatment) when the individual has contraindications to anticoagulation, a known bleeding disorder (e.g., hemophilia), or is unable to ambulate; 2. Adjunct pharmacologic prophylaxis for patients undergoing elective hip, or knee arthroplasty, who have had a previous venous thromboembolism; 3. As an alternative to low molecular weight (LMW) heparin after hip surgery. (i.e. Consistent, high-quality evidence indicates that pneumatic compression and LMW heparin have similar efficacy for prevention of DVT and that pneumatic compression therapy reduces the likelihood of complications related to bleeding and drainage). Note*: There is consistent, high-quality evidence indicating that pneumatic compression devices stimulate circulation and reduce the incidence of deep vein thrombosis (DVT) versus no preventative therapy. Investigational Health Net, Inc. considers the following use of pneumatic compression devices investigational for post-surgical prevention of deep vein thrombosis (DVT). There is a lack of high-quality, sufficient, peer-reviewed, long-term evidence to determine the relative safety and efficacy of the following treatments: 1. As an alternative to warfarin or an alternative to unfractionated heparin after hip surgery; Penumatic Compression Post Surgery Sep 17 2

3 2. As an adjunct to LMWH, aspirin, warfarin, unfractionated heparin, or graduated compression stockings after hip surgery, unless the patient meets criteria in #3 noted above (i.e., in medically necessary criteria; 3. Alone OR as an alternative to LMWH alone for DVT prevention after knee surgery; 4. As an alternative to aspirin, graduated compression stockings, or continuous passive motion therapy for DVT prevention; 5. As an adjunct to aspirin, graduated compression stockings, or continuous passive motion therapy as alternatives to aspirin alone, compression stockings alone, or continuous passive motion therapy alone for DVT prevention, respectively. Not Medically Necessary Health Net, Inc. considers the use of pneumatic compression devices contraindicated and therefore not medically necessary in individuals with evidence of leg ischemia due to peripheral vascular disease. Key Words Definitions VTE VTED IPCD LMW LMWH PCD Venous thromboembolism Venous thromboembolic disease Intermittent pneumatic compression device Low molecular weight Low molecular weight heparin Pneumatic compression device Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes Pulmonary embolism and infarction Acute venous embolism and thrombosis of deep vessels of lower extremity ICD-10 Codes I I I Pulmonary embolism Phlebitis and thrombophlebitis Other venous embolism and thrombosis CPT Codes N/A HCPCS Codes E0676 Intermittent limb compression device (includes all accessories), not otherwise specified Penumatic Compression Post Surgery Sep 17 3

4 Scientific Rationale Initial Pneumatic compression therapy attempts to prevent blood clots by improving blood flow from the legs to the heart by repeatedly applying waves of pressure to the feet or legs. The goal of this therapy is to prevent or reduce the extent of deep vein thromboses in the legs that can cause potentially fatal pulmonary embolism. Pneumatic compression devices (PCD) consist of an inflatable garment for the arm or leg and an electrical pneumatic pump that fills the garment with compressed air. The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices. These devices have been used in the treatment of peripheral vascular disease (PVD), peripheral artery disease (PAD), venous and arterial ulcers, lymphedema, and for the prevention of deep vein thrombosis. Intermittent pneumatic compression (IPC) is an alternative for venous thromboembolism (VTE) prevention in patients with a high risk of bleeding or in whom anticoagulation is contraindicated (eg, active or intracranial hemorrhage). Data supporting the use of IPC for the prevention of VTE in surgical patients is limited. However, of the mechanical devices (IPC, GCS, VFP), efficacy appears best with IPC use. Meta-analyses of small randomized trials agree that IPC use is superior to no prophylaxis and graduated compression stockings, and may offer additive benefit to surgical patients on LMW heparin. The largest meta-analysis, which included data on patients enrolled in 70 trials, reported that IPC was more effective than no prophylaxis in reducing DVT (7.3 versus 16.7 percent; relative risk [RR] 0.43; 95% CI 0.36 to 0.52) and PE (1.2 versus 2.8 percent, RR 0.48; 95% CI ) without any effect on mortality. On further analysis, although the addition of pharmacologic prophylaxis to IPC further reduced the risk of DVT (RR 0.54; 95% CI ), it had no effect on the incidence of PE. IPC is contraindicated in patients with evidence of leg ischemia due to peripheral vascular disease. Although there are no data available on skin complications of IPC use, skin breakdown is a known complication, especially in the frail, older adult population. In addition, practical considerations for amputees or patients with burns or extensive skin lesions (eg, Stevens Johnson s syndrome) may limit its use. In this context, although one device can be applied to any extremity, its efficacy in the prevention of VTE is not assured and likely limited. Several categories of these devices exist and include the following: A non-segmented pneumatic compressor is a device which has a single outflow port on the compressor. The fact that the air from the single tube may be transmitted to a sleeve/appliance with multiple compartments or segments does not affect the coding of the compressor. A segmented pneumatic compressor is a device which has multiple outflow ports on the compressor which lead to distinct segments on the appliance which inflate sequentially. A segmented device without calibrated gradient pressure is one in which either the same pressure is present in each segment or there is a predetermined pressure gradient in successive segments but no ability to individually set or adjust pressures in each of several segments. Segmental gradient pressure pneumatic appliances are appliances/sleeves which are used with a non-segmented pneumatic compressor but which achieve a pressure gradient through the design of the tubing and/or air chambers. A non-segmented pneumatic compressor is used with appliances/sleeves. Penumatic Compression Post Surgery Sep 17 4

5 Segmented pneumatic compressors are used with appliances/sleeves. There following are some of the portable pneumatic compression devices that have received 510K FDA approval: K113525: ActiveCare DVT and ActiveCare+SFT (Medical Compression Systems [DBN] Ltd.) cleared on January 31, 2012 K110159: ActiveCare SFT (Medical Compression Systems [DBN] Ltd.) cleared on May 12, 2011 K073028: Venowave Models VW5-6, VW5-10, VW5-20 AND VW5-30 (Venowave Inc.) cleared on March 7, 2008 K060146: ActiveCare ++ System (Medical Compression Systems [DBN] Ltd.) cleared on March 8, 2006 Position Statements The American Academy of Orthopaedic Surgeons (AAOS, 2012) published an updated guideline on prevention of venous thromboembolism in patients undergoing elective hip and knee arthroplasty. The guideline included the following recommendations relevant to this policy: The use of pharmacologic agents and/or mechanical compressive devices for the prevention of venous thromboembolism in patients undergoing elective hip or knee arthroplasty, and who are not at elevated risk beyond that of the surgery itself for venous thromboembolism or bleeding. (Grade of Recommendation: Moderate) Current evidence is unclear about which prophylactic strategy (or strategies) is/are optimal or suboptimal. Therefore, the work group is unable to recommend for or against specific prophylactics in these patients. (Grade of Recommendation: Inconclusive) In the absence of reliable evidence about how long to employ these prophylactic strategies, it is the opinion of this work group that patients and physicians discuss the duration of prophylaxis. (Grade of Recommendation: Consensus) In the absence of reliable evidence, it is the opinion of this work group that patients undergoing elective hip or knee arthroplasty, and who have also had a previous venous thromboembolism, receive pharmacologic prophylaxis and mechanical compressive devices. (Grade of Recommendation: Consensus) In the absence of reliable evidence, it is the opinion of this work group that patients undergoing elective hip or knee arthroplasty, and who also have a known bleeding disorder (e.g., hemophilia) and/or active liver disease, use mechanical compressive devices for preventing venous thromboembolism. (Grade of Recommendation: Consensus) The American College of Chest Physicians (ACCP, 2012) updated their evidence based guidelines on the Prevention of VTE in Orthopedic Surgery Patients with the following information: Antithrombotic Therapy and Prevention of Thrombosis does not address pneumatic compression therapy for patients in the home setting for the prevention of VTE. The guideline states, Intermittent pneumatic compression devices (IPCD) to prevent VTE for acutely ill hospitalized medical patients at increased risk of thrombosis who are bleeding or at high risk for major bleeding, the expert panel suggests the optimal use of mechanical thromboprophylaxis with Penumatic Compression Post Surgery Sep 17 5

6 graduated compression stockings (GCS) (*Grade 2C) or intermittent pneumatic compression (IPC) (Grade 2C), rather than no mechanical thromboprophylaxis. The American College of Chest Physicians (ACCP) guidelines also suggest the use of low molecular weight heparin (LMWH) in preference to the other agents that are recommended as alternatives, and in patients receiving pharmacological prophylaxis, the guidelines suggest adding an intermittent pneumatic compression device (IPCD) during the hospital stay. In addition, the guidelines suggest extending thromboprophylaxis for up to 35 days in patients. Lastly, in patients at increased bleeding risk, the guidelines suggest an IPCD or no prophylaxis instead of pharmacological therapy. When bleeding risk decreases, and if VTE risk persists, the expert panel suggests that pharmacologic thromboprophylaxis be substituted for mechanical thromboprophylaxis (*Grade 2B) (Khan, et al., 2012). Note* - The ACCP uses the following grading system: Grade 1 Strong recommendation Grade 2 Weak recommendation Grade A High grade evidence Grade B Moderate grade evidence Grade C - Low grade evidence The Australia and New Zealand Working Party (2007) on the Management and Prevention of Venous Thromboembolism recommend the following: The use of intermittent pneumatic compression and/or graduated compression stockings combined with LMWH or fondaparinux for prevention of DVT after total knee replacement. If intermittent pneumatic compression is not possible, a foot pump can be used with compression stockings. These treatments should be continued for 5 to 10 days after surgery. The French Society for Anaesthesiology and Intensive Care notes the following: Evidence-based practice guidelines state that LMWHs are the standard treatment for prevention of VTE after knee replacement surgery. Although these guidelines do not recommend mechanical methods such as intermittent pneumatic compression as a first-line treatment for prevention of DVT, the guidelines state that mechanical methods are preferred when anticoagulants are contraindicated due to risk of bleeding (Samama et al., 2006). A more recent update to these guidelines was not located during the 2013 update search for this report. The International Consensus Statement: A collaborative effort that was initiated by several European medical organizations resulted in the creation of an evidence-based International Consensus Statement, which included contributions by 45 clinicians from Europe, the United States, Japan, Egypt, Israel, South Africa, Argentina, and Australia (Nicolaides et al., 2013). The statement is the fifth version and was previously published in 2006 (Nicolaides et al., 2006). For prevention of VTE, this consensus statement recommends use of LMWH before and after surgery as being best supported by the evidence. In addition, intermittent pneumatic compression therapy is recommended in the presence of contraindications to LMWH (level of evidence: low) until full ambulation. Penumatic Compression Post Surgery Sep 17 6

7 Of note when considering guidelines for treatment, the Consensus Statement highlights that data from total hip replacement should not be extrapolated to total knee replacement as the incidence of asymptomatic DVT detected by venography is higher in patients having total knee replacement than total hip replacement; however, the incidence of above-knee DVT is lower than in patients having total hip replacement. National Institute for Health and Care Excellence (NICE, 2010): An evidence-based guideline prepared by NICE recommends that patients undergoing knee replacement surgery should be offered combined mechanical and pharmacological treatments to reduce the risk of VTE. The mechanical methods listed in the guideline are antiembolism stockings, foot impulse devices, and intermittent pneumatic compression devices. Mechanical treatment should continue until significantly reduced mobility ends, and pharmacological treatment should last 10 to 14 days after surgery, depending on the agent being used. United States Public Health Service, Surgeon General (September 2008 (Rathbun, 2009): The goals of the call to action included increasing public knowledge on the signs, symptoms, and risk of VTE, employment of effective prevention for those at highest risk, and development of new scientific strategies to treat and prevent the long-term morbidity of the disease. No updates have been released since 2008; however, the need for additional research on treatments such as pneumatic compression and potentially increase the amount of research on such treatments. Knee surgery was not addressed. Studies There is an interventional, randomized Clinical Trial that is currently recruiting participants on Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology. It was last verified in September 2012, and the estimated study completion date is October The ClinicalTrials.gov Identifier is NCT This study is comparing the efficacy of aspirin (acetylsalicylic acid) and pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic compression devices in preventing deep vein thrombosis in patients with pelvic and lower extremity malignant tumors and undergoing surgery. Pneumatic compression devices alone are not sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in patients with musculoskeletal tumors which have determined whether one drug is better than another. The knowledge gained from this study will determine whether aspirin and pneumatic compression devices is the same or better than enoxaparin and pneumatic compression devices in preventing deep vein thrombosis in this patient population and may result in fewer wound and bleeding complications. Arabi et al. (2013) A limited amount of data exist regarding the effect of intermittent pneumatic compression (IPC) and graduated compression stockings (GCS) on the incidence of VTE in the ICU setting. The objective of this study was to examine the association of mechanical thromboprophylaxis with IPC or GCS with the risk of VTE and hospital mortality among critically ill medical-surgical patients. In this prospective cohort study of patients admitted to the ICU of a tertiary-care medical center between July 2006 and January 2008, we used multiple propensity scores adjustment to examine the association of IPC and GCS with VTE. The primary outcome was incident VTE, including DVT and pulmonary embolism. The following Penumatic Compression Post Surgery Sep 17 7

8 data were collected: patient demographics, admission physiologic data, VTE risk factors, pharmacologic thromboprophylaxis, and mechanical thromboprophylaxis. RESULTS: Among 798 patients enrolled in the study, incident VTE occurred in 57 (7.1%). The use of IPC was associated with a significantly lower VTE incidence compared with no mechanical thromboprophylaxis (propensity scores adjusted hazard ratio, 0.45; 95% CI, ; P =.04). GCS were not associated with decreased VTE incidence. No significant interaction was found between the mechanical thromboprophylaxis group and the type of prophylactic heparin used (P =.99), recent trauma (P =.66), or recent surgery (P =.07) on VTE risk. The use of IPC, but not GCS, was associated with a significantly lower VTE risk. This association was consistent regardless of the type of prophylactic heparin used and was not modified by trauma or surgical admission. Ho et al. (2013) Optimal thromboprophylaxis for patients at risk of bleeding remains uncertain. This meta-analysis assessed whether intermittent pneumatic compression (IPC) to the lower limbs was effective in reducing venous thromboembolism (VTE), and whether combining pharmacologic thromboprophylaxis with IPC would enhance its effectiveness. Two reviewers searched the MEDLINE, EMBASE, and Cochrane controlled trial register (1966- February 2013) for randomized controlled trials and assessed the outcomes and quality of the trials independently. Trials comparing IPC with pharmacologic thromboprophylaxis, thromboembolic deterrent stockings (TEDS), no prophylaxis, and a combination of IPC and pharmacologic thromboprophylaxis were considered. Trials that used IPC<24 hours or compared different types of IPC were excluded. A total of 16,164 hospitalized patients from 70 trials met inclusion criteria and were subject to meta-analysis. IPC was more effective than no IPC prophylaxis in reducing deep vein thrombosis (DVT)(7.3% vs. 16.7%, absolute risk reduction [ARR]9.4%, 95% confidence interval [CI] %; relative risk [RR]RR 0.43, 95%CI , p<0.01; I(2)=34%) and pulmonary embolism (PE) (1.2% vs. 2.8%, ARR 1.6%, 95%CI %; RR 0.48,95%CI , p<0.01; I(2)=0%). IPC was also more effective than TEDS in reducing DVT, and appeared to be as effective as pharmacologic thromboprophylaxis but with a reduced risk of bleeding (RR 0.41, 95%CI , p<0.01; I(2)=0%). Adding pharmacologic thromboprophylaxis to IPC further reduced the risk of DVT (RR 0.54, 95%CI , p=0.02; I(2)=0%) compared to IPC alone. IPC was effective in reducing VTE; combining pharmacologic thromboprophylaxis with IPC was more effective than using IPC alone. Zhao et al. (2012) Total hip replacement (THR) is an effective treatment for reducing pain and improving function and quality of life in patients with hip disorders. While this operation is very successful, deep vein thrombosis (DVT) and pulmonary embolism (PE) are significant complications after THR. Different types of intermittent pneumatic compression (IPC) devices have been used for thrombosis prophylaxis in patients following THR. Available devices differ in compression garments, location of air bladders, patterns of pump pressure cycles, compression profiles, cycle length, duration of inflation time and deflation time, or cycling mode such as automatic or constant cycling devices. Despite the widely accepted use of IPC for the treatment of arterial and venous diseases, the relative effectiveness of different types of IPC systems as prophylaxis against thrombosis after THR is still unclear. To assess the comparative effectiveness and safety of different IPC devices with respect to the prevention of venous thromboembolism in patients after THR. Randomized and quasi-randomized controlled studies were eligible for inclusion. Two review authors independently selected trials, assessed trials for eligibility and methodological quality, and extracted data. Disagreement was resolved by discussion or, if necessary, referred to a third review author. Only one quasi-randomized controlled study with 121 study participants comparing two types of IPC devices met the inclusion criteria. The authors found no cases of symptomatic DVT or PE in either the Penumatic Compression Post Surgery Sep 17 8

9 calf-thigh compression group or the plantar compression group during the first three weeks after the THR. The calf-thigh pneumatic compression was more effective than plantar compression for reducing thigh swelling during the early postoperative stage. The strength of the evidence in this review is weak as only one trial was included and it was classified as having a high risk of bias. There is a lack of evidence from randomized controlled trials to make an informed choice of IPC device for preventing venous thromboembolism (VTE) following total hip replacement. More research is urgently required, ideally a multicenter, properly designed RCT including a sufficient number of participants. Clinically relevant outcomes such as mortality, imagingdiagnosed asymptomatic VTE and major complications must be considered. Falck-Ytter et al. (2012) VTE is a serious, but decreasing complication following major orthopedic surgery. This guideline focuses on optimal prophylaxis to reduce postoperative pulmonary embolism and DVT. The methods of this guideline follow those described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines in this supplement. In patients undergoing major orthopedic surgery, the authors recommend the use of one of the following rather than no antithrombotic prophylaxis: low-molecular-weight heparin; fondaparinux; dabigatran, apixaban, rivaroxaban (total hip arthroplasty or total knee arthroplasty but not hip fracture surgery); low-dose unfractionated heparin; adjusted-dose vitamin K antagonist; aspirin (all Grade 1B); or an intermittent pneumatic compression device (IPCD) (Grade 1C) for a minimum of 10 to 14 days. The authors suggest the use of low-molecular-weight heparin in preference to the other agents we have recommended as alternatives (Grade 2C/2B), and in patients receiving pharmacologic prophylaxis, we suggest adding an IPCD during the hospital stay (Grade 2C). We suggest extending thromboprophylaxis for up to 35 days (Grade 2B). In patients at increased bleeding risk, we suggest an IPCD or no prophylaxis (Grade 2C). In patients who decline injections, the authors recommend using apixaban or dabigatran (all Grade 1B). The authors also suggest against using inferior vena cava filter placement for primary prevention in patients with contraindications to both pharmacologic and mechanical thromboprophylaxis (Grade 2C). The authors recommend against Doppler (or duplex) ultrasonography screening before hospital discharge (Grade 1B). For patients with isolated lower-extremity injuries requiring leg immobilization, no thromboprophylaxis is suggested (Grade 2B). For patients undergoing knee arthroscopy without a history of VTE, no thromboprophylaxis is recommended (Grade 2B). Optimal strategies for thromboprophylaxis after major orthopedic surgery include pharmacologic and mechanical approaches. Sobieraj-Teague et al. (2012) Patients undergoing neurosurgical procedures are at risk of venous thromboembolism (VTE), but often have contraindications for anticoagulant prophylaxis. This study assessed the efficacy and tolerability of a new, lightweight, portable, battery-powered, intermittent calf compression device, Venowave, for the prevention of VTE in neurosurgical inpatients. The authors performed an open randomized controlled trial comparing Venowave with control for the prevention of VTE in patients undergoing neurosurgery. The primary outcome was the composite of asymptomatic deep vein thrombosis (DVT) detected by screening venography or compression ultrasound performed on day 9 (+/-2 days) and symptomatic VTE. 75 patients were randomized to receive Venowave devices and 75 to the control group. All patients were prescribed graduated compression stockings and physiotherapy. VTE occurred in three patients randomized to Venowave and in 14 patients randomized to control (4.0% vs. 18.7%, relative risk 0.21; 95% confidence interval , P=0.008). Similar reductions were seen for proximal DVT (2.7% vs. 8.0%) and symptomatic VTE (0% vs. 2.7%), and the results were consistent in all subgroups examined. Venowave devices are effective in Penumatic Compression Post Surgery Sep 17 9

10 preventing VTE in high-risk neurosurgical patients. (2011 International Society on Thrombosis and Haemostasis). Mont et al. (2011) The work group, including the American Academy of Orthopaedic Surgeons (AAOS), evaluated the available literature concerning various aspects of patient screening, risk factor assessment, and prophylactic treatment against venous thromboembolic disease (VTED), as well as the use of postoperative mobilization, neuraxial agents, and vena cava filters. The group recommended further assessment of patients who have had a previous venous thromboembolism but not for other potential risk factors. Patients should be assessed for known bleeding disorders, such as hemophilia, and for the presence of active liver disease. Patients who are not at elevated risk of VTED or for bleeding should receive pharmacologic prophylaxis and mechanical compressive devices for the prevention of VTED. The group did not recommend specific pharmacologic agents and/or mechanical devices. The work group recommends, by consensus opinion, early mobilization for patients following elective hip and knee arthroplasty. The use of neuraxial anesthesia can help limit blood loss but was not found to affect the occurrence of VTED. No clear evidence was established regarding whether inferior vena cava filters can prevent pulmonary embolism in patients who have a contraindication to chemoprophylaxis and/or known VTED. Lastly, recommendations for patients who have also had a previous venous thromboembolism (VTE) include receiving pharmacological prophylaxis and mechanical compressive devices. Importantly, with regard to all of these recommendations and of particular importance for the present report, the AAOS notes that DVT is considered a surrogate outcome for the measurement of more critical outcomes such as major bleeding, pulmonary emboli, and all-cause mortality. Thus, DVT is not considered a primary outcome variable of importance. In summary, the risk of post-operative venous thrombosis (VTE) or post-op DVT, depends upon the surgical procedure (eg, degree of invasiveness, type and duration of anesthesia, requirement for immobilization), as well as patient-related variables (i.e., increasing age, prior VTE or DVT, presence of malignancy or obesity, presence of an inherited or acquired hypercoagulable state). The optimal preventive measure of venous thromboembolism or deep vein thrombosis should be based on the degree of risk, while balancing potential treatment benefits and risks in each individual patient. Therefore, although many studies have been done regarding the efficacy of pneumatic compression devices post surgery, very specific criteria regarding whether or not PCDs should be used alone or along with pharmacological agents, may need to be determined based upon the individual situation. Per the studies that have been done, the use of PCDs is superior to no prophylaxis and graduated compression stockings, and may offer additive benefit to surgical patients on LMW heparin. Review History September 2013 September 2014 September 2015 September 2016 September 2017 Medical Advisory Council, Committee Initial Approval Update no revisions. Codes updated. Update - no revisions. Codes updated. Update - no revisions. Codes updated. Update no revisions This policy is based on the following evidence-based guidelines: 1. American Academy of Orthopaedic Surgeons (AAOS): The 2007 AAOS guideline, Prevention of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty. Updated 9/24/2011. Current title, Guideline on Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty. 2. American College of Chest Physicians (ACCP): The 2008 ACCP Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Penumatic Compression Post Surgery Sep 17 10

11 Clinical Practice Guidelines (8th Edition). Updated in New title, Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. 3. Hayes. Search & Summary. Patient Compliance with Portable Pneumatic Compression Devices for the Prevention of Postoperative Deep Vein Thrombosis (DVT). July Update Aug Hayes. Medical Technology Directory. Intermittent Pneumatic Compression for Peripheral Arterial Disease. July 12, Update June Hayes. Search & Summary. Pneumatic Compression for Arterial Insufficiency. December 19, Hayes. Medical Technology Directory. Pneumatic Compression for Prevention of Deep Vein Thrombosis Following Hip Surgery. May 31, Updated May 13, Updated April 9, Updated Apr Hayes. Medical Technology Directory. Pneumatic Compression for Prevention of Deep Vein Thrombosis Following Knee Surgery. August 14, Update Aug National Institute for Health and Clinical Excellence (NICE). Venous thromboembolis: reducing the risk. Developed by the National Collaborating Centre for Acute and Chronic Conditions. London, UK: National Institute for Health and Clinical Excellence; NICE Clinical Guideline No Hayes. Health Technology Brief. Portable Versus Non-Portable Intermittent Pneumatic Compression for Prevention of Postoperative Deep Vein Thrombosis. January 31, Update Jan Hayes. Health Technology Brief. Portable Pneumatic Compression Versus Low- Molecular-Weight Heparin for Prevention of Deep Vein Thrombosis After Lower- Extremity Joint Arthroplasty. February 3, Update Jan 2015 References Update September Broderick BJ, O'Connell S, Moloney S, et al. Comparative lower limb hemodynamics using neuromuscular electrical stimulation (NMES) versus intermittent pneumatic compression (IPC). Physiol Meas Sep;35(9): Hamilton WG, Reeves JD, Fricka KB, et al. Mechanical thromboembolic prophylaxis with risk stratification in total knee arthroplasty. J Arthroplasty Jan;30(1): Koo KH, Choi JS, Ahn JH, et al. Comparison of clinical and physiological efficacies of different intermittent sequential pneumatic compression devices in preventing deep vein thrombosis: a prospective randomized study. Clin Orthop Surg Dec;6(4): Zhao JM, He ML, Xiao ZM, et al. Different types of intermittent pneumatic compression devices for preventing venous thromboembolism in patients after total hip replacement. Cochrane Database Syst Rev Dec 22;12:CD References Update September Cochrane Database Syst Rev Nov 14. Different types of intermittent pneumatic compression devices for preventing venous thromboembolism in patients after total hip replacement. 2. Sobieraj DM, Coleman CI, Tongbram V, et al. Comparative effectiveness of combined pharmacologic and mechanical thromboprophylaxis versus either method alone in major orthopedic surgery: a systematic review and metaanalysis. Penumatic Compression Post Surgery Sep 17 11

12 References Initial 2. Arabi YM, Khedr M, Dara SI, et al. Use of Intermittent Pneumatic Compression and Not Graduated Compression Stockings Is Associated With Lower Incident VTE in Critically Ill Patients: A Multiple Propensity Scores Adjusted Analysis. Chest. 2013;144(1): Autar R. Evidence based venous thromboprophylaxis in patients undergoing total hip replacement (THR), total knee replacement (TKR) and hip fracture surgery (HFS). Int J Orthop Trauma Nurs. 2011;15(3): Braceshop.com. Aircast Venaflow Elite Vascular System Available at: System-534p1626.htm?gclid=COWfm82X4bcCFQyg4AodrQQACQ. 3. Bonow: Braunwald's Heart Disease - A Textbook of Cardiovascular Medicine, 9th ed Saunders, An Imprint of Elsevier. Mechanical Measures. 4. Caprini JA. Mechanical Methods for Thrombosis Prophylaxis. Clin Appl Thromb. 2010;16(6): Chattopadhyay D, Al Samaraee A, Bhattacharya V. An update on the Management and Treatment of Deep Vein Thrombosis. Cardiovasc Hematol Agents Med Chem. 2011;9(4): Chin PL, Amin MS, Yang KY, Yeo SJ, Lo NN. Thromboembolic prophylaxis for total knee arthroplasty in Asian patients: a randomised controlled trial. J Orthop Surg (Hong Kong). 2009;17(1): Clinicaltrial.gov. Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology. ClinicalTrials.gov Identifier: NCT September Available at: RESSION+DEVICE+POST+SURGERY&rank=1 8. Colwell CW Jr, Froimson MI, Mont MA, et al. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. J Bone Joint Surg Am. 2010;92(3): Cronan JJ. Deep vein thrombosis: imaging diagnosis and related controversies. Ultrasound Clin. 2011: DOTmed. KENDALL SCD Sequel 7325 Pump Vascular Compression For Sale - DOTmed Listing #640485: Center for Devices and Radiological Health (CDRH). 510(k) Premarket Notification Database [search: Product Code JOW]. Compressible Limb Sleeve. Updated March 3, Food and Drug Administration. 12. Colwell CW Jr, Froimson MI, Mont MA, et al. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. J Bone Joint Surg Am. 2010;92(3): Edwards JZ, Pulido PA, Ezzet KA, Copp SN, Walker RH, Colwell CW Jr. Portable compression device and low-molecular-weight heparin compared with lowmolecular-weight heparin for thromboprophylaxis after total joint arthroplasty. J Arthroplasty. 2008;23(8): Eymin G, Jaffer AK. Thromboprophylaxis in major knee and hip replacement surgery: a review. J Thromb Thrombolysis. 2012;34(4): Falck-Ytter Y, Francis CW, Johanson NA, et al. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e278S-325S. doi: /chest Freischlag JA, Heller JA. Venous disease. In: Townsend CM, Beauchamp RD, Evers BM, Mattox KL, editors. Sabiston Textbook of Surgery. The Biological Basis of Modern Surgical Practice. 19th ed. Philadelphia, PA: Saunders; Ch 65 Penumatic Compression Post Surgery Sep 17 12

13 17. Galanis T, Kraft WK, Merli GJ. Prophylaxis for deep vein thrombosis and pulmonary embolism in the surgical patient. Adv Surg. 2011;45: Hardwick ME, Pulido PA, Colwell CW Jr. A mobile compression device compared with low-molecular-weight heparin for prevention of venous thromboembolism in total hip arthroplasty. Orthop Nurs. 2011;30(5): Hill J, Treasure T; National Clinical Guideline Centre for Acute and Chronic Conditions. Reducing the risk of venous thromboembolism in patients admitted to hospital: summary of NICE guidance. BMJ. 2010;340:c Ho KM, Tan AJ. Stratified Meta-Analysis of Intermittent Pneumatic Compression to the Lower Limbs to Prevent Venous Thromboembolism in Hospitalized Patients. Circulation Jul. 21. Ho WK. Deep vein thrombosis--risks and diagnosis. Aust Fam Physician. 2010;39(6): Johnson SA, Stevens SM, Woller SC, et al. Risk of deep vein thrombosis following a single negative whole-leg compression ultrasound: a systematic review and meta-analysis. JAMA. 2010;303(5): Kessler CM, Cap AP. Prevention of Venous Thromboembolism in Hospitalized Medical Patients. Cancer Invest. 2009;27(Suppl 1): Levy YD, Hardwick ME, Copp SN, Rosen AS, Colwell CW Jr. Thrombosis Incidence in Unilateral vs. Simultaneous Bilateral Total Knee Arthroplasty with Compression Device Prophylaxis. J Arthroplasty. 2013;28(3): Liew NC, Chang YH, Choi G, et al. Asian venous thromboembolism guidelines: prevention of venous thromboembolism. Int Angiol. 2012;31(6): Mason: Murray and Nadel's Textbook of Respiratory Medicine, 5th ed Saunders, An Imprint of Elsevier. Prevention of Venous THromboembolism. 27. Medcom Group Ltd. AV Impulse & ImPads Meena Medical Equipment Inc. Kendall SCD Express 9525 Compression System Available at: xgat Mont MA, Jacobs JJ, Boggio LN, et al. Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Am Acad Orthop Surg Dec;19(12): Nicolaides A, Hull RD, Fareed J. Prevention and treatment of venous thromboembolism: international consensus statement (guidelines according to scientific evidence). Clin Appl Thromb Off J Int Acad Clin Appl Thromb. 2013;19(2): Pai M, Douketis JD. Prevention of venous thromboembolic disease in surgical patients. UpToDate. August 23, Rathbun S. Cardiology patient pages. The Surgeon General s call to action to prevent deep vein thrombosis and pulmonary embolism. Circulation. 2009;119(15):e Roderick P, Ferris G, Wilson K, et al. Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis. Health Technol Assess. 2005;9(49):iii-iv, ix-x, Sobieraj-Teague M, Hirsh J, Yip G, et al. Randomized controlled trial of a new portable calf compression device (Venowave) for prevention of venous thrombosis in high-risk neurosurgical patients. Journal of Thrombosis and Haemostasis. 10 (2) (pp ), SportsBraces.com. Aircast VenaFlow System Warwick D. Prevention of venous thromboembolism in total knee and hip replacement. Circulation. 2012;125(17): Windisch C, Kolb W, Kolb K, et al. Pneumatic compression with foot pumps facilitates early postoperative mobilisation in total knee arthroplasty. Int Orthop. 2011;35(7): Penumatic Compression Post Surgery Sep 17 13

14 38. Zhao JM, He ML, Xiao ZM, et al. Different types of intermittent pneumatic compression devices for preventing venous thromboembolism in patients after total hip replacement. Cochrane Database Syst Rev Nov 14;11:CD doi: / Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Penumatic Compression Post Surgery Sep 17 14

15 Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Penumatic Compression Post Surgery Sep 17 15