MEDICAL POLICY POLICY RELATED POLICIES POLICY GUIDELINES CODING DESCRIPTION SCOPE BENEFIT APPLICATION RATIONALE REFERENCES APPENDIX HISTORY Cooling Devices Used in the Outpatient Setting Number 1.01.26 Effective Date June 1, 2016 Revision Date(s) 05/10/16; 02/01/16; 06/09/15; 06/09/14; 06/10/13; 04/08/13; 04/10/12 Replaces N/A Policy [TOP] Active and passive cooling devices, with or without compression, used in the outpatient setting are considered not medically necessary. Related Policies [TOP] 1.01.525 Postsurgical Outpatient Use of Limb Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis Policy Guidelines [TOP] Coding E1399 E0218 E0236 E0650 E0651 E0652 HCPCS Durable medical equipment, miscellaneous Water circulating cold pad with pump Pump for water circulating pad Pneumatic Compressor, nonsegmental home model Pneumatic compressor, segmental home model without calibrated gradient pressure Pneumatic compressor, segmental home model with calibrated gradient pressure Description [TOP] Cooling devices use chilled water to decrease the local temperature of tissue. There are a variety of cooling devices available, ranging from gravity-fed devices that are manually filled with iced water, to motorized units that both cool and circulate the chilled water. These devices are typically used when ice packs would normally be applied, e.g., after orthopedic surgical procedures. Background Cold and/or compression therapy following surgery or musculoskeletal and soft tissue injury has long been accepted in the medical field as an effective tool for reducing inflammation, pain, and swelling. Ice packs and various bandages and wraps are commonly used. In addition, a variety of continuous cooling devices are commercially available and can be broadly subdivided into those providing manually operated passive cold therapy and those providing active cold therapy using a mechanical device. Passive Cooling Devices The CryoCuff® and Polar Care Cub devices are examples of passive cooling devices. CryoCuff® device consists of an insulated container filled with iced water that is attached to a compressive cuff. When the CryoCuff® container is raised, the water fills and pressurizes the cuff. The amount of pressure is proportional to the height of the container. When body heat warms the water, the cooler is lowered and the water drains out. The cooler is then raised above the affected limb, and cold water refills the compressive cuff. Polar Care Cub unit consists of pads held in place with elastic straps, which may also provide compression. The pads are attached to a built-in hand pump that circulates the water through the pads at the same time as increasing the compression around the joint. Active Cooling Devices In active cooling devices, a motorized pump circulates chilled water and may also provide pneumatic compression. AutoChill® device, which may be used in conjunction with a CryoCuff®, consists of a pump that automatically exchanges water from the cuff to the cooler, eliminating the need for manual water recycling. CTM™ 5000 and cTreatment are computer-controlled devices that provide cooling at a specific (11°C) and continuous temperature. Game Ready™ Accelerated Recovery System is an example of an active cooling device combined with a pneumatic component. The system consists of various soft wraps and a computer-control unit to circulate the water through the wraps and provide intermittent pneumatic compression. Hilotherm® Clinic circulates cooled water through preshaped thermoplastic polyurethane facial masks for use after different types of facial surgery. Hot/Ice Thermal Blanket is another example of an active cooling device. It consists of 2 rubber pads connected by a rubber hose to the main cooling unit. Fluid is circulated via the hose through the thermal blankets. The temperature of the fluid is controlled by the main unit and can be either hot or cold. IceMan Cryotherapy unit uses a semi-closed loop system with a mechanical pump that allows warm water to circulate, at a constant flow rate, with cooler water providing consistent cold distribution throughout the pad. Kinex ThermoComp Device and NanoTherm systems combine cold therapy with intermittent pneumatic compression. ThermaZone® provides thermal therapy with pads specific to various joints, as well as different areas of the head (front, sides, back, eyes). Regulatory Status A large number of active and passive heating and cooling devices have received U.S Food and Drug Administration (FDA) 510(k) clearance since 1976. FDA product code: ILO. Scope [TOP] Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage. Benefit Application [TOP] Refer to benefit or contract language when assessing whether passive cooling devices would be considered durable medical equipment. Rationale [TOP] This policy was created in November 2004 and periodically updated with a literature review using the MEDLINE database. The most recent update was performed through April, 2016. The standard postoperative treatment for musculoskeletal surgeries consists of cryotherapy (cold therapy) and various types of compressive wraps. Both ice packs (with or without additives to maintain temperature) and cooling devices can provide cryotherapy. Active cooling devices are designed to provide a constant low temperature, which might provide additional benefit compared with the more variable temperature achieved with the intermittent replacement of ice packs. Passive cooling devices might also allow less variable cooling due to the larger volume of ice stored in the insulated tank and the use of circulated ice water. Therefore, the evidence review focused on the following questions to evaluate whether cooling devices provide a benefit (e.g., decreased pain, swelling, analgesic use) beyond convenience. Is there a health benefit from intermittent passive or active cooling devices when the number of exchanges of ice bags and episodes of water recirculation are the same? Do continuous cooling regimens provide more health benefits than intermittent cooling? Does the use of cooling devices in the outpatient setting provide health benefits when compared with icing regimens typically used in a home/outpatient environment? Manually Operated Passive Cooling Devices Intermittent Cooling Regimens Konrath et al. reported on the results of a trial that randomly assigned 103 patients undergoing reconstruction of the anterior cruciate ligament (ACL) to 1 of 4 different postoperative cold therapy strategies: (1) active cooling with a Polar Care pad set at a temperature of 40 to 50 degrees, or (2) 70 to 80 degrees centigrade, respectively; (3) ice packs; or (4) no cold therapy. (1) Both the water in the Polar Care pad and the ice packs were changed every 4 hours. The length of hospital stay, range of motion (ROM) at discharge, use of oral and intramuscular pain medicine, and drain output were not significantly different among groups. These results suggest that the Polar Care device provides no incremental benefit in comparison with ice packs when used with the same intermittent treatment regimen. Continuous versus Intermittent Cooling Regimens A systematic review of cryotherapy concluded that continuous cold therapy was associated with a significantly greater decrease in pain and wrist circumference after surgery than intermittent cold therapy. (2) The 1 study reviewed compared continuous cryotherapy with intermittent 20-minute ice applications over the first 3 days after carpal tunnel release. (3) Continuous cooling resulted in a decrease in pain and wrist circumference in comparison with intermittent ice packs. The systematic review concluded that for cryotherapy in general, there was a lack of high-quality studies and recommended that future studies focus on modes, durations, and frequencies of ice application to optimize outcomes after injury. (2) Schroder and Passler compared the CryoCuff® device with ice therapy in 44 patients who had undergone repair of the ACL. (4) Those receiving ice therapy received an ice bag 3 times a day postoperatively. While those randomly assigned to the CryoCuff® groups reported significant decreases in pain, swelling, and analgesic use, it is not clear whether icing 3 times a day is a typical icing regimen. Unknown Cooling Regimens Whitelaw et al. reported results of a trial that randomly assigned 102 patients undergoing knee arthroscopy in the outpatient setting to receive either a CryoCuff® device or traditional ice therapy. (5) Those in the CryoCuff® group reported decreased pain medication compared with the control group, but there was no significant difference in average pain assessment. Interpretation of these results is limited because the number of exchanges of ice packs and water recirculation was not reported. Healy et al. reported that the CryoCuff® device provided no benefit to pain control or swelling compared with ice packs in a randomized trial of 76 patients (105 knees) undergoing total knee arthroplasty (TKA). (6) No data were provided on the number of ice pack exchanges, although the water was recirculated in the CryoCuff® device every 1 to 4 hours. No Icing Control Edwards et al. studied the outcomes of 71 patients undergoing ACL reconstruction who were randomly assigned to receive either CryoCuff® therapy with ice water, CryoCuff® therapy with room temperature water, or no cold therapy. (7) Therefore, this trial did not include the relevant control group of patients treated with conventional ice packs. Another randomized trial by Brandsson et al. suffers from the same limitation; in this study of 50 patients undergoing ACL repair, no group received standard therapy with ice packs. (8) Levy and Marmar compared the outcomes in a trial that randomly assigned 80 patients (100 knees) undergoing TKA to receive either passive cold therapy with a CryoCuff® device or no cold therapy. (9) Although the CryoCuff® group reported a significant decrease in blood loss and mild decrease in analgesic requirements, this trial also did not include the relevant control group. Active Cooling Devices Intermittent Cooling Regimens In the largest study to date, 116 patients who had undergone TKA were assigned in a quasi-randomized order to 8 hours daily of advanced cryotherapy at a fixed temperature (cTreatment) or to application of cold packs for 15 minutes after each of the 2 physical therapy sessions. (10) Both groups could apply cryotherapy during the evening and night whenever they wanted for comfort and pain control. Thirty percent of patients in the cTreatment group did not use the device at night due to excessive noise. Primary outcomes were VAS at rest and during deep active knee flexion, walking without aid, and analgesic use. Secondary outcomes were knee ROM, active straight leg raising, walking without aid, swelling, visual hematoma, and length of stay. There was no significant difference between the groups in VAS, need for analgesics, or for any of the secondary outcomes. There was a significant decrease in flexion at 6 weeks in the advanced cryotherapy group (114° vs 120°). A randomized, controlled trial (n=60) compared a temperature-controlled cryotherapy device with a standard icing regimen following outpatient knee arthroscopy. (11) Seven patients (12%) were excluded from analysis or lost to follow-up. Both groups were instructed to apply the treatment for 20 minutes every 2 hours during waking hours for the first 4 days after surgery. For night time, the cooling device group was instructed to use the device throughout the first 4 nights, whereas the control group was advised to use ice packs at their own discretion. No differences in daytime pain were observed between the 2 groups. There was a tendency for more patients in the cryotherapy group to report that they did not awaken from pain during the night; this difference reached significance only for postoperative day 2 (36% vs 6%; p=0.04). Additional study with a larger number of patients is needed to determine whether use of continuous cooling at night improves health outcomes. Another study compared a consecutive series of patients who were instructed to use ice packs with results from a prior group that had used active cooling devices following ACL repair. (12,13) For the first 3 days, patients were instructed to change the ice packs when the crushed ice had melted, then to apply ice as needed over days 4 through 7. Although pain scores and use of pain medication were lower in the cohort that used a cooling device in comparison with the group that was instructed to continuously apply ice packs, the study is limited by the nonconcurrent design. Several studies have been reported by 1 research group comparing the Hilotherm® device versus cooling compresses. In one randomized observer-blinded study, 42 patients were treated with open reduction and internal fixation for zygomatic bone fractures and then randomly assigned to a Hilotherm® cooling face mask or a standard cooling compress. (14) Both cooling methods were intended to be used continuously for 12 hours daily for 3 days after surgery; however no data were provided on whether patients in the control group used the cold compresses for a similar amount of time as patients used the face mask. Blinded evaluation with a 3-dimensional optical scanner showed a significant reduction in swelling on day 1, 2, 3, and 7 for the Hilotherm® group. The visual analog scale (VAS) for pain was lower in the Hilotherm® group on day 1 (2.38 vs. 4.10 on a 10-point scale) and day 2 (2.34 vs. 4.38), but not on day 7 (1.43 vs. 1.90). There were also significant differences between the groups for postoperative neurologic score and eye motility and diplopia on postoperative day 1. Another randomized study with 32 patients assessed postoperative swelling of bilateral mandibular fractures using a cooling mask around the head and jaw. (15) The study design was similar to that reported by Modabber et al. Swelling was reduced for the cooling mask group on day 1, 2, and 3 after surgeries. VAS for pain was also reduced for the cooling mask group on day 1 (3.87 vs. 5.53) and day 2 (3.63 vs. 6.31). There was no significant difference between groups in postoperative neurologic score, trismus, or mandibular dysfunction. No Icing Control Several randomized studies compared active cooling devices with no cold therapy and therefore are not relevant to the documentation of benefit compared with standard therapy with ice packs. (13,16-18) Section Summary There are several randomized trials that have compared active cooling devices with standard intermittent icing or cold packs. Two smaller trials suggest a benefit of continuous cooling on pain and swelling of the face. Two larger trials found no significant benefit of the continuous cooling devices compared with standard cryotherapy after knee surgery. Combination Active Cooling and Compression (Cryopneumatic) Devices Intermittent Cooling Regimens A multicenter randomized trial with 280 TKA patients compared the Game Ready cryopneumatic device versus ice packs with static compression. (19) On discharge from the hospital, the treatments were given at the same application cycle of 1 hour on and 30 minutes off. Compliance rates were similar for the two groups. Blinded evaluation of 187 patients (67% of patients had complete evaluations) found no significant difference between the groups in VAS for pain, range of motion, 6-minute walk test, timed up and go test, or knee girth under this more typical icing regimen. Narcotic consumption was decreased from 680 mg to 509 mg morphine equivalents over the first 2 weeks (14 mg less per day), and patient satisfaction was increased with the cryopneumatic device. Waterman et al. reported a randomized controlled trial (RCT) of the Game Ready device in 36 patients with ACL reconstruction. (20) Patients were instructed to use ice or the cryopneumatic device for 30 minutes at least 3 times per day and return to the clinic at 1,2, and 6 weeks postoperatively. Compliance during the first 2 weeks was not significantly different between the 2 groups (100% for Game Ready, 83% for icing). The primary outcome measure (VAS) was not comparable at baseline, limiting interpretation of the results. There were no significant differences between the groups for knee circumference, the Lysholm, 36-Item Short-Form Health Survey, or single assessment numerical evaluation scores. A greater percentage of patients treated with the Game Ready device discontinued narcotic use by 6 weeks (83% vs. 28%). In 2015, Kraeutler et al. conducted a randomized controlled trial to compare the effect of compressive cryotherapy (CC) vs. ice on postoperative pain in patients undergoing shoulder arthroscopy for rotator cuff repair or subacromial decompression. The commercial device used for postoperative CC was Game Ready. A standard ice wrap (IW) was used for postoperative cryotherapy alone. Patients scheduled for rotator cuff repair or subacromial decompression were randomized to 1 of 2 groups; patients were randomized to use either CC or a standard IW for the first postoperative week. All patients were asked to complete a "diary" each day, which included visual analog scale scores based on average daily pain and worst daily pain as well as total pain medication usage. Pain medications were then converted to a morphine equivalent dosage. Forty-six patients completed the study and were available for analysis; 25 patients were randomized to CC and 21 patients were randomized to standard IW. No significant differences were found in average pain, worst pain, or morphine equivalent dosage on any day.The authors concluded that CC using the Game Ready device did not demonstrate significant reduction in postoperative pain or narcotic use in patients undergoing shoulder arthroscopy for rotator cuff repair or subacromial decompression. They stated: “On the basis of these results, we cannot recommend routine use of CC over standard IWs after shoulder arthroscopy.” In 2015, Hayes, Inc. published a Health Technology Brief reviewing evidence from eleven prospective randomized controlled trials. Their review found no evidence of a consistent benefit of cold compression therapy, either passive or active pump-controlled cooling and compression devices when compared with conservative therapy, cold therapy alone, compression therapy alone, cold therapy combined with static compression, gaseous cryotherapy or epidural analgesia for pain. Compared with cold therapy alone, cold compression therapy showed only a modest benefit in short-term pain relief. No functional improvements were reported. Limitations of the eleven studies included variation in the mode, frequency, and duration of the cold compression therapy and differences between surgical procedures across studies. Hayes concluded that, while cold compression therapy appears to be safe, there is insufficient evidence of a clinical benefit of cold compression therapy. Other Devices and Indications Use of cooling devices after TKA in the inpatient setting was examined in a 2009 systematic review and metaanalysis. (21) The 11 RCTs included were heterogeneous for the type of cooling device and the exact control condition (ranging from no ice to frequent icing). Overall, cryotherapy was found to result in small benefits in blood loss and discharge knee ROM. There were no benefits in transfusion and analgesia requirements, pain, swelling, length of stay, and gains in knee ROM after discharge. These results are limited by the heterogeneity of the studies. No published articles focusing on the role of cooling devices in nonsurgical settings, i.e., for the treatment of sprains or strains or chiropractic treatments have been identified. Ongoing and Unpublished Clinical Trials A search of ClinicalTrials.gov in April 2016 did not identify any trials likely to influence this policy. Clinical Input Received From Physician Specialty Societies and Academic Medical Centers While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. 2008 Input In response to requests, input was received from 3 specialty societies and 3 academic medical centers while the policy was under review in 2008. Input was mixed regarding the medical necessity of continuous cooling devices. Summary of Evidence Most of the published randomized studies of passive cooling devices failed to adequately describe the cooling regimens or include the relevant control group of standard ice pack treatment. When passive cooling devices and ice packs were used with the same regimen, no differences in health outcomes were observed. Currently available evidence is insufficient to determine whether continuous cooling devices result in improved health outcomes when compared with usual ice pack exchange in the home environment. Several small studies report that a cooling mask used after facial surgery provides greater pain relief and reduction of swelling compared with cool compresses, but these studies have limitations and results need to be replicated in larger, higher quality studies. Overall, the available scientific literature is insufficient to document that the use of passive or active cooling systems is associated with a benefit beyond convenience; these devices are considered not medically necessary. Combination Active/Compression (Cryopneumatic) For combination active cryotherapy/compression (cryopneumatic) devices, 2 studies in 2012 reported that narcotic use was decreased and that patient satisfaction was higher. However, no other outcome measures were improved, and one of the studies suffered from a low follow-up rate. A 2015 RCT comparing compressive therapy to a standard ice wrap reported no significant difference in postoperative pain or narcotic use on any day. A 2015 Health Technology Brief published by Hayes, Inc. concluded that, while cold compression therapy appears to be safe, there is insufficient evidence of a clinical benefit of cold compression therapy. Based on these new studies with active cryotherapy/compression devices and limited evidence of an improvement in clinical outcomes, active cryotherapy/compression devices are considered not medically necessary. Practice Guidelines and Position Statements In December 2015, the American Academy of Orthopedic Surgeons released a clinical practice guideline on surgical management of osteoarthritis of the knee. Regarding cryotherapy devices, they stated: “Moderate evidence supports that cryotherapy devices after knee arthroplasty (KA) do not improve outcomes.” Cryotherapy was also included in a list of interventions that “were considered but not recommended”. U.S. Preventive Services Task Force Recommendations Not applicable. Medicare National Coverage While there is no national coverage decision for Medicare, cooling devices are addressed in Durable Medical Equipment Resource Center (DMERC) policy. Last reviewed in July 2004, the DMERC policy reads as follows: “A device in which ice water is put in a reservoir and then circulated through a pad by means of gravity is not considered durable medical equipment (DME). Other devices (not all-inclusive which are also not considered to be DME are: single use packs which generate cold temperature by a chemical reaction; packs which contain gel or other material which can be repeatedly frozen; simple containers into which ice water can be placed. All of these types of devices must be coded A9270 if claims are submitted to the DMERC.” “Code E0218 describes a device which has an electric pump that circulates cold water through a pad…. A water circulating cold pad with pump (E0218) will be denied as not medically necessary.” References [TOP] 1. Konrath GA, Lock T, Goitz HT, et al. The use of cold therapy after anterior cruciate ligament reconstruction. A prospective, randomized study and literature review. Am J Sports Med. 1996; 24(5):629-633. 2. Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sport Med. 2004; 32(1):251-261. 3. Hochberg J. A randomized prospective study to assess the efficacy of two cold therapy treatments following carpal tunnel release. J Hand Ther. 2001;14(3):208-215. 4. Schroder D, Passler HH. Combination of cold compression, after knee surgery. A prospective randomized trial. Knee Surg Sports Traumatol Arthrosc. 1994; 2(3):158-165. 5. Whitelaw GP, DeMuth KA, Demos HA, et al. The use of the Cryo/Cuff versus ice and elastic wrap in the postoperative care of knee arthroscopy patients. Am J Knee Surg. 1995; 8(1):28-31. 6. Healy WL, Seidman J, Pfeifer BA, et al. Cold compressive dressing after total knee arthroplasty. Clin Orthop Relat Res. Feb 1994(299):143-146. PMID 7907012 7. Edwards DJ, Rimmer M, Keene GC. The use of cold therapy in the postoperative management of patients undergoing arthroscopic anterior cruciate ligament reconstruction. Am J Sports Med. 1996; 24(2):193-195. 8. Brandsson S, Rydgren B, Hedner T, et al. Postoperative analgesic effects of an external cooling system and intra-articular bupivicaine/morphine after arthroscopic cruciate ligament surgery. Knee Surg Sports Traumatol Arthrosc. 1996; 4(4):200-205. 9. Levy AS, Marmar E. The role of cold compression dressings in the postoperative treatment of total knee arthroplasty. Clin Orthop Relat Res. Dec 1993(297):174-178. PMID 7902225 10. Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty? Clin Orthop Relat Res. Nov 2014;472(11):3417-3423. PMID 25059851 11. Woolf SK, Barfield WR, Merrill KD, et al. Comparison of a continuous temperature-controlled cryotherapy device to a simple icing regimen following outpatient knee arthroscopy. J Knee Surg. 2008; 21(1):15-19. 12. Barber FA. A comparison of crushed ice and continuous flow cold therapy. Am J Knee Surg. 2000; 13(2):97-101. 13. Barber FA, McGuire DA, Click S. Continuous-flow cold therapy for outpatient anterior cruciate ligament reconstruction. Arthroscopy. 1998;14(2):130-135. 14. Modabber A, Rana M, Ghassemi A, et al. Three-dimensional evaluation of postoperative swelling in treatment of zygomatic bone fractures using two different cooling therapy methods: a randomized, observer-blind, prospective study. Trials. 2013; 14:238. PMID 23895539 15. Rana M, Gellrich NC, von See C, et al. 3D evaluation of postoperative swelling in treatment of bilateral mandibular fractures using 2 different cooling therapy methods: a randomized observer blind prospective study. J Craniomaxillofac Surg. Jan 2013; 41(1):e17-23. PMID 22626630 16. Cohn BT, Draeger RI, Jackson DW. The effects of cold therapy in the postoperative management of pain in patients undergoing anterior cruciate ligament reconstruction. Am J Sports Med. 1989; 17(3):344-349. PMID 17. Dervin GF, Taylor DE, Keene GC. Effects of cold and compression dressings on early postoperative outcomes for the arthroscopic anterior cruciate ligament reconstruction patient. J Orthop Sports Phys Ther. 1998; 27(6):403-406. 18. Saito N, Horiuchi H, Kobayashi S, et al. Continuous local cooling for pain relief following total hip arthroplasty. J Arthroplasty. 2004; 19(3):334-337. 19. Su EP, Perna M, Boettner F, et al. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br. Nov 2012; 94(11 Suppl A):153-156. PMID 23118406 20. Waterman B WJ, Swaims C, et al. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. 2012; 25(2):155-160 PMID 23118406 21. Adie S, Naylor JM, Harris IA. Cryotherapy after total knee arthroplasty: a systematic review and metaanalysis of randomized controlled trials. J Arthroplasty. 2010;25(5):709-715 22. BlueCross BlueShield Association Medical Policy Reference Manual “Cooling Devices Used in the Outpatient Setting” Policy No. 1.01.26. 2015. 23. Kraeutler MJ, Reynolds KA, Long C, et al. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. 2015;24(6):854-9. 24. Hayes, Winifred S. Health Technology Brief. Cold Compression Therapy for Orthopedic Conditions. November 20, 2015 Available at: http://www.hayesinc.com. Accessed April 20, 2016. 25. American Academy of Orthopaedic Surgeons (AAOS). Surgical management of osteoarthritis of the knee: evidence-based clinical practice guideline. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS); 2015 Dec 4. Appendix [TOP] N/A History [TOP] Date 08/09/11 Reason New policy created with literature review through 2010 with not medically necessary policy statement. ICD-10 codes included. Policy approved with 90-day hold for provider notification; the policy effective date is February 8, 2012. 02/23/12 04/25/12 04/08/13 06/10/13 02/13/14 06/19/14 06/17/15 02/01/16 05/10/16 Typo corrected; code A9273 corrected within Policy Guidelines section. Replace policy. Policy updated with literature review through November 2011; need for policy affirmed; policy statement unchanged. Replace policy. Policy updated with literature review through January 7 2013; references 10 and 12 added; active cryopneumatic/compression devices now considered investigational; passive cooling devices remain not medically necessary. HCPCS code E1399 added to policy. Replace policy. Policy statements clarified to distinguish between active cooling devices (not medically necessary) and combination active cryopneumatic devices (investigational). Passive cooling devices remain not medically necessary. VascuTherm added as an example of combination active cooling/compression device. HCPCS code A9270 removed from the policy; A codes are not utilized for billing. Update Related Policies. Change title to 1.01.525. Annual Review. Policy updated with literature review through March 17, 2014; references 13-14 added; policy statement unchanged. CPT code 97010 removed; it does not suspend for review. Annual Review. Policy updated with literature review through March 2, 2015; reference 10 added; policy statement unchanged. Coding update. Added E0650 and E0651. Annual Review. Policy updated with literature review. Policy statement on combination active cooling and compression changed from investigational to not medically necessary. References added. Trade names for active cooling devices added to Description section. Added code E0650. Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Com pany adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contra cts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2016 Premera All Rights Reserved. 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You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Getting Help in Other Languages This Notice has Important Information. This notice may have important information about your application or coverage through Premera Blue Cross. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-722-1471 (TTY: 800-842-5357). አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ። ( العربيةArabic): قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو.يحوي ھذا اإلشعار معلومات ھامة قد تكون ھناك تواريخ مھمة.Premera Blue Cross التغطية التي تريد الحصول عليھا من خالل وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة.في ھذا اإلشعار اتصل. يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة.في دفع التكاليف 800-722-1471 (TTY: 800-842-5357)بـ 中文 (Chinese): 本通知有重要的訊息。本通知可能有關於您透過 Premera Blue Cross 提交的 申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期 之前採取行動,以保留您的健康保險或者費用補貼。您有權利免費以您的母 語得到本訊息和幫助。請撥電話 800-722-1471 (TTY: 800-842-5357)。 037338 (07-2016) Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. Français (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermédiaire de Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous devrez peut-être prendre des mesures par certains délais pour maintenir votre couverture de santé ou d'aide avec les coûts. Vous avez le droit d'obtenir cette information et de l’aide dans votre langue à aucun coût. Appelez le 800-722-1471 (TTY: 800-842-5357). Kreyòl ayisyen (Creole): Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357). Deutsche (German): Diese Benachrichtigung enthält wichtige Informationen. Diese Benachrichtigung enthält unter Umständen wichtige Informationen bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357). Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357). Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357). 日本語 (Japanese): この通知には重要な情報が含まれています。この通知には、Premera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ ります。この通知に記載されている可能性がある重要な日付をご確認くだ さい。健康保険や有料サポートを維持するには、特定の期日までに行動を 取らなければならない場合があります。ご希望の言語による情報とサポー トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話 ください。 Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 (TTY: 800-842-5357). 한국어 (Korean): 본 통지서에는 중요한 정보가 들어 있습니다. 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다. 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다. 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다. 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오. Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357). ລາວ (Lao): ແຈ້ ງການນ້ີ ມີຂ້ໍ ມູ ນສໍາຄັ ນ. ແຈ້ ງການນ້ີ ອາດຈະມີຂ້ໍ ມູ ນສໍາຄັ ນກ່ ຽວກັ ບຄໍາຮ້ ອງສະ ໝັ ກ ຫື ຼ ຄວາມຄຸ້ ມຄອງປະກັ ນໄພຂອງທ່ ານຜ່ ານ Premera Blue Cross. ອາດຈະມີ ວັ ນທີສໍາຄັ ນໃນແຈ້ ງການນີ້. ທ່ ານອາດຈະຈໍາເປັນຕ້ ອງດໍາເນີນການຕາມກໍານົ ດ ເວລາສະເພາະເພື່ອຮັ ກສາຄວາມຄຸ້ ມຄອງປະກັ ນສຸ ຂະພາບ ຫື ຼ ຄວາມຊ່ ວຍເຫື ຼ ອເລື່ອງ ຄ່ າໃຊ້ ຈ່ າຍຂອງທ່ ານໄວ້ . ທ່ ານມີສິດໄດ້ ຮັ ບຂ້ໍ ມູ ນນ້ີ ແລະ ຄວາມຊ່ ວຍເຫື ຼ ອເປັນພາສາ ຂອງທ່ ານໂດຍບໍ່ເສຍຄ່ າ. ໃຫ້ ໂທຫາ 800-722-1471 (TTY: 800-842-5357). ភាសាែខម រ (Khmer): េសចកត ីជូនដំណឹងេនះមានព័ត៌មានយា៉ងសំខាន់។ េសចកត ីជូនដំណឹងេនះរបែហល ជាមានព័ត៌មានយា៉ងសំខាន់អំពីទរមង់ែបបបទ ឬការរា៉ប់រងរបស់អនកតាមរយៈ Premera Blue Cross ។ របែហលជាមាន កាលបរ ិេចឆ ទសំខាន់េនៅកនុងេសចកត ីជូន ដំណឹងេនះ។ អន ករបែហលជារតូវការបេញច ញសមតថ ភាព ដល់កំណត់ៃថង ជាក់ចបាស់ នានា េដើមបីនឹងរកសាទុកការធានារា៉ប់រងសុខភាពរបស់អនក ឬរបាក់ជំនួយេចញៃថល ។ អន កមានសិទធិទទួ លព័ត៌មានេនះ និងជំនួយេនៅកនុងភាសារបស់អនកេដាយមិនអស លុយេឡើយ។ សូ មទូ រស័ពទ 800-722-1471 (TTY: 800-842-5357)។ ਪੰ ਜਾਬੀ (Punjabi): ਇਸ ਨੋਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357). ( فارسیFarsi): اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم. اين اعالميه حاوی اطالعات مھم ميباشد به تاريخ ھای مھم در. باشدPremera Blue Cross تقاضا و يا پوشش بيمه ای شما از طريق شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه. اين اعالميه توجه نماييد شما حق. به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد،ھای درمانی تان برای کسب.اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد ( تماس800-842-5357 تماس باشمارهTTY )کاربران800-722-1471 اطالعات با شماره .برقرار نماييد Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-722-1471 (TTY: 800-842-5357). Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter esta informação e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357). Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Español (Spanish): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357). Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357). ไทย (Thai): ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่ มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร 800-722-1471 (TTY: 800-842-5357) Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357). Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).