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Aetna Aetna
Clinical Policy Bulletin:
Cryoanalgesia and Therapeutic Cold
Number: 0297


Policy

  1. Aetna considers the use of cryoanalgesia medically necessary for the temporary relief of pain due to chronic refractory trigeminal neuralgia (see Appendix for selection criteria).

  2. Aetna considers intra-operative cryoanalgesia of the intercostal nerves medically necessary for the management of post-thoracotomy pain.  

  3. Aetna considers the passive cold compression therapy units (e.g., AirCast Cryo Cuff, AirCast Cryo Strap, the Polar Care Cub unit, and the Polar Pack) medically necessary DME to control swelling, edema, hematoma, hemarthrosis and pain.  Aetna considers the passive cold compression therapy units experimental and investigational for all other indications because their effectiveness for indications other than the ones listed above has not been established.

  4. Aetna considers active cold compression therapy units with mechanical pumps and portable refrigerators (e.g., AutoChill, Game Ready, IceMan, NanoTherm, Prothermo, and Vascutherm) experimental and investigational because they have not been proven to offer clinically significant benefits over passive cold compression therapy units.  

  5. Aetna considers the use of the Hot/Ice Machine and similar devices (e.g., the Hot/Ice Thermal Blanket, the TEC Thermoelectric Cooling System (an iceless cold compression device), the VitalWear Cold/Hot Wrap, and the VitalWrap) experimental and investigational for reducing pain and swelling after surgery or injury.  Studies in the published literature have been poorly designed and have failed to show that the Hot/Ice Machine offers any benefit over standard cryotherapy with ice bags/packs; and there are no studies evaluating its use as a heat source.

Note: Aetna considers passive hot and cold therapy medically necessary.  Mechanical circulating units with pumps have not been proven to be more effective than passive hot and cold therapy.



Background

Cryoanalgesia for Trigeminal Neuralgia:

Trigeminal neuralgia (TN), also known as tic douloureux, is a disorder characterized by excruciating episodic pain in the areas innervated by one or more divisions (usually the mandibular and maxillary, rarely the ophthalmic divisions) of the trigeminal nerve.  The anti-epileptic drug carbamazepine (Tegretol) is the drug most frequently used for the management of TN.  For patients who can not tolerate carbamazepine because of its adverse side effects (poor liver function, confusion, ataxia, drowsiness, and allergic responses), the literature indicates baclofen and other anticonvulsant drugs such as clonazepam (Klonopin) may be useful.

Cryoanalgesia, cryotherapy, or cryoneurotomy has also been used in the treatment of TN.  It entails the use of high pressure (approximately 600 pounds per square inch) gas (nitrous oxide or carbon dioxide) administered by a 12- to 14-G needle-shaped cryoprobe.  Studies have shown that cryoanalgesia provides temporary pain relief or cure with minimal morbidity (e.g., no permanent sensory loss) in patients with refractory TN.

Intra-operative Cryoanalgesia for the Management of Post-Thoracotomy Pain:

Thoracotomy, the establishment of an opening into the chest cavity for the management of various cardiopulmonary disorders/diseases, is one of the most painful surgical incisions.  Post-thoracotomy pain impairs patients' ability to breathe deeply and cough frequently to prevent atelectasis.  Pain relief medication may decrease the coughing reflex as well as depress respiratory functions when the dosage is high enough to achieve analgesia.  On the other hand, if the dosage of analgesics is too low to relieve pain, it may render patients with shallow breathing and inadequate coughing reflex.  Epidural anesthesia or analgesia may produce some pain relief, but the side effects of severe hypotension, nausea, and urinary retention, as well as the variability of effect limit the usefulness of this approach.  Intercostal or paravertebral nerve blocks by means of local anesthetics and severing of the intercostal nerves have also been used to reduce incisional pain following thoracotomy.  However, the duration of relief for neural blockade is only a few hours and the procedure is painful, while severing of the intercostal nerves during thoracotomy may result in neuromas, which cause late post-operative pain.

Cryoanalgesia has been used on the intercostal nerves to reduce post-thoracotomy pain.  Although the procedure is generally performed prior to closure of the chest at the completion of thoracotomy and may add 10 to 15 mins to the total operating time, it can also be carried out percutaneously in a clinical setting.  Cryoanalgesia of the intercostal nerves circumvents the need for repetitive injections of nerve blocks and avoids the toxicity of long acting agents, which may lead to chemically induced intercostal neuritis.  Additionally, it frees skilled personnel from intensive observation required following epidural anesthesia or analgesia.  Findings of many studies have demonstrated that intra-operative cryoanalgesia of the intercostal nerves is safe and effective in managing pain following thoracotomy.

It is not generally medically necessary to perform thoracic epidural analgesia or intravenous continuous analgesia in addition to cryoanalgesia for patients undergoing thoracotomy.  In a randomized controlled study, Yang et al (2004) examined the effects of cryoanalgesia combined with thoracic epidural analgesia on pain and respiratory complications in patients undergoing thoracotomy.  Cryoanalgesia combined with thoracic epidural analgesia was associated with earlier recovery in pulmonary function, less pain during movement and a lower daily requirement for rescue analgesia 1 week after surgery.  However, the combination of cryoanalgesia and epidural analgesia failed to decrease the incidence of long-term pain and numbness.  In view of its associated long-term morbidity, cryoanalgesia combined with thoracic epidural analgesia is not recommended for patients undergoing thoracotomy.  Furthermore, Gwak et al (2004) also reported that intravenous continuous analgesia combined with cryoanalgesia was ineffective at lowering the incidence of post-thoracotomy pain.

Cold Therapy Units and Hot/Ice Machine:

Cold therapy units are devices in which fluid flows through a blanket or cuff, providing immediate cooling to an affected area.  The AirCast Cryo/Cuff uses a insulated jug filled with cold water attached to a cuff.  Elevating the jug fills and pressurizes the cuff.  Compression is controlled by gravity, and is proportional to the elevation of the cooler.  When body heat warms the water, it is re-chilled simply by lowering the cooler.  Another passive cold compression therapy unit is the Polar Care Cub unit.

More complicated cold therapy units may employ mechanical pumps and refrigerators that are powered by battery or electricity (e.g., IceMan).  The Game Ready system is an example of an active cooling device that combines cold and intermittent pneumatic compression therapies.  The system consists of a wrap, a connector hose, and a control unit.  The wrap contains two internal chambers, one for air and the other for cooling water.  The microprocessor control unit features various adjustable compression cycles and temperature controls.  However, there is no evidence that these more complicated cold therapy units provide any additional benefit over the CryoCuff or conventional ice bags or packs.  Aetna's current policy on mechanical cold therapy pumps is consistent with Medicare DME MAC policy.

Leutz and Harris (1995) described a retrospective study that assessed 52 consecutive patients who underwent total knee arthroplasty (TKA).  A total of 33 patients underwent TKA and received cold therapy pads placed over a thin dressing in the operating room; 19 patients underwent TKA using an identical operative and post-operative procedure, but did not receive continuous cold therapy.  Continuous cold therapy consisted of 2 sterile plastic pads connnected by rubber hoses containing cool water from an electric main unit that maintained a constant temperature of 42 degrees F for the immediate post-operative period.  Cold therapy pads were used an average of 3 days and removed with the first dressing change.  Patients who had continuous cold therapy averaged a 200 ml decrease in post-operative blood loss.  There was no significant difference in the amount of narcotic use, transfusion requirements, or hospital stay between the two groups.  Post-operative swelling and range of motion were not consistently recorded.  Twenty-eight other variables were also examined, but no significant differences were found between groups.  Based on these results, the authors stated that they can not recommend continuous cold therapy or justify the extra expense for all patients who undergo TKA.

A Hot/Ice Machine consists of 2 rubber pads connected by a rubber hose to a unit that circulates hot or cold fluid through the pads.  Studies in the published literature have been poorly designed and have failed to show that the Hot/Ice Machine offers any benefit over standard cryotherapy with ice packs, and there are no studies evaluating the use of this device as a heat source.

The VitalWrap (VitalWear Inc. South San Francisco, CA) is an active heating/cooling device that allows the user to circulate either hot or cold fluid through the system.  The VitalWrap system consists of a bladder filled body wrap/pad, tubing, and a reservoir/pump device.  Cooled or heated water may be added to the pump reservoir and then circulated through the tubing to the body wrap/pad and then back to the reservoir.  The benefits of this type of device above other cooling or heating methods have not been established at this time.

Vascutherm (ThermoTek, Carrollton, TX) is an active cold compression therapy unit with a pneumatic pump.  It provides heating, cooling and compression therapies.  The device also includes a deep vein thrombosis (DVT) mode -- this is a compression (or air) only mode, that is intended to prevent DVT.  However, it provides no additional clinical utility or impact on health outcomes than the use of ice or compression wraps.

The TEC Thermoelectric Cooling System (Maldonado Medical, Phoenix, AZ) is marketed to reduce post-operative pain and edema.  It is an iceless cold therapy compression/deep vein thrombosis (DVT) prophylaxis machine that can also provide heat.  It is limited to a cold temperature of 49 degrees F to minimize the potential for frostbite.  However, it provides no additional clinical utility or impact on health outcomes than the use of ice or compression wraps.

Appendix

Selection Criteria of Cryoanalgesia for Trigeminal Neuralgia:

  1. Members have experienced pain for at least 6 months, and 

  2. Members have tried and failed pharmacotherapies (e.g., baclofen, carbamazepine, phenytoin), or are unable to tolerate the side effects of the medication. 

Repeat cryoanalgesia may be medically necessary every 6 months.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
64400
64420
64421
64600
64620
97010
HCPCS codes not covered for indications listed in the CPB:
E0217 Water circulating heat pad with pump
E0218 Water circulating cold pad with pump
E0236 Pump for water circulating pad
E0249 Pad for water circulating heat unit
Other HCPCS codes related to the CPB:
E0230 Ice cap or collar
E0650 Pneumatic compressor; non-segmental home model [not covered for active cold compression therapy units]
E0651 Pneumatic compressor, segmental home model without calibrated gradient pressure [not covered for active cold compression therapy units]
E0652 Pneumatic compressor, segmental home model with calibrated gradient pressure [not covered for active cold compression therapy units]
E0660 Non-segmental pneumatic appliance for use with pneumatic compressor; full leg [not covered for active cold compression therapy units]
E0666 Non-segmental pneumatic appliance for use with pneumatic compressor, half leg [not covered for active cold compression therapy units]
E0667 Segmental pneumatic appliance for use with pneumatic compressor, full leg [not covered for active cold compression therapy units]
E0669 Segmental pneumatic appliance for use with pneumatic compressor, half leg [not covered for active cold compression therapy units]
E0671 Segmental gradient pressure pneumatic appliance; full leg[not covered for active cold compression therapy units]
E0673 Segmental gradient pressure pneumatic appliance, half leg [not covered for active cold compression therapy units]
E0676 Intermittent limb compression device (includes all accessories), not otherwise specified [not covered for active cold compression therapy units]
J0475, J0476 Injection, baclofen
J1165 Injection, phenytoin sodium, per 50 mg
ICD-9 codes covered if selection criteria are met (not all-inclusive):
338.0 - 338.4 Pain
350.1 Trigeminal neuralgia
611.71 Mastodynia
719.00 - 719.09 Effusion of joint
719.10 - 719.19 Hemarthrosis
719.40 - 719.49 Pain in joint
724.2 Lumbago
724.5 Backache, unspecified
729.0 Rheumatism, unspecified and fibrositis
729.1 Myalgia and myositis, unspecified
729.2 Neuralgia, neuritis, and radiculitis, unspecified
729.5 Pain in limb
729.81 Swelling of limb
780.96 Generalized pain
782.3 Edema
786.50 - 786.59 Chest pain
789.00 - 789.09 Abdominal pain
920 - 924.9 Contusion with intact skin surface


The above policy is based on the following references:

Cryoanalgesia for Trigeminal Neuralgia:

  1. Barnard D, Lloyd J, Evans J. Cryoanalgesia in the management of chronic facial pain. J Max Fac Surg. 1981;9(2):101-102. 
  2. Goss AN. Peripheral cryoneurectomy in the treatment of trigeminal neuralgia. Aust Dent J. 1984;29(4):222-224. 
  3. Nehme AE, Warfield CA. Cryoanalgesia: Freezing of peripheral nerves. Hosp Pract. 1987;22(1A):71-72, 77. 
  4. Politis C, Adriaensen H, Bossuyt M, Fossion E. The management of trigeminal neuralgia with cryotherapy. Acta Stomatologica Belgica. 1988;85(3):197-205. 
  5. Zakrzewska JM, Thomas DGT. Patient's assessment of outcome after three surgical procedures for the management of trigeminal neuralgia. Acta Neurochirurgica. 1993;122:225-230. 

Intra-operative Cryoanalgesia for the Management of Post-Thoracotomy Pain:

  1. Orr IA, Keenan DJ, Dundee JW. Improved pain relief after thoracotomy: Use of cryoprobe and morphine infusion. Br Med J (Clin Res Ed). 1981;283(6297):945-948. 
  2. Maiwand MO, Makey AR, Rees A. Cryoanalgesia after thoracotomy. Improvement of technique and review of 600 cases. J Thorac Cardiovasc Surg. 1986;92(2):291-295. 
  3. Jones MJT, Murrin KR. Intercostal block with cryotherapy. Ann R Coll Surg Engl. 1987;69(6):261-262. 
  4. Roberts D, Pizzarelli G, Lepore V, et al. Reduction of post-thoracotomy pain by cryotherapy of intercostal nerves. Scand J Thor Cardiovasc Surg. 1988;22(2):127-130. 
  5. Shafei H, Chamberlain M, Natrajan KN, et al. Intrapleural bupivacaine for early post-thoracotomy analgesia - Comparison with bupivacaine intercostal block and cryofreezing. Thorac Cardiovasc Surgeon. 1990;38(1):38-41. 
  6. Pastor J, Morales P, Cases E, et al. Evaluation of intercostal cryoanalgesia versus conventional analgesia in postthoracotomy pain. Respiration. 1996;63(4):241-245. 
  7. Yang MK, Cho CH, Kim YC. The effects of cryoanalgesia combined with thoracic epidural analgesia in patients undergoing thoracotomy. Anaesthesia. 2004;59(11):1073-1077.
  8. Gwak MS, Yang M, Hahm TS, et al. Effect of cryoanalgesia combined with intravenous continuous analgesia in thoracotomy patients. J Korean Med Sci. 2004;19(1):74-78.
  9. Momenzadeh S, Elyasi H, Valaie N, et al. Effect of cryoanalgesia on post-thoracotomy pain. Acta Med Iran. 2011;49(4):241-245.
  10. Sepsas E, Misthos P, Anagnostopulu M, et al. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Feb 19. [Epub ahead of print]

Cold Therapy Units and Hot/Ice Machine:

  1. Cohn BT, Draeger RI, Jackson DW. The effects of cold therapy on the postoperative management of pain in patients undergoing anterior cruciate ligament reconstruction. Am J Sports Med. 1989;17(3):344-349. 
  2. Bert JM, Stark JG, Maschka K, Chock C. The effect of cold therapy on morbidity subsequent to arthroscopic lateral retinacular release. Orthop Rev. 1991;20(9):755-758. 
  3. Barber FA, McGuire DA, Click S. Continuous-flow cold therapy for outpatient anterior cruciate ligament reconstruction. Arthroscopy. 1998;14(2):130-135. 
  4. Konrath GA, Lock T, Goitz HT, Scheidler J. 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. 
  5. Ebner CA. Cold therapy and its effect on procedural pain in children. Issues Comp Pediatr Nurs. 1996;19(3):197-208. 
  6. 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. 
  7. Scarcella JB, Cohn BT. The effect of cold therapy on postoperative course of total hip and knee arthroplasty patients. Am J Orthop. 1995;24(11):847-852. 
  8. Leutz DW, Harris H. Continuous cold therapy in total knee arthroplasty. Am J Knee Surg. 1995;8(4):121-123. 
  9. Daniel DM, Stone ML, Arendt DL. The effect of cold therapy on pain, swelling, and range of motion after anterior cruciate ligament reconstructive surgery. Arthroscopy. 1994;10(5):530-533. 
  10. Finan MA, Roberts WS, Hoffman MS, et al. The effects of cold therapy on postoperative pain in gynecologic patients: A prospective, randomized study. Am J Obstet Gynecol. 1993;168(2):542-544. 
  11. Amin-Hanjani S, Corcoran J, Chatwani A. Cold therapy in the management of postoperative cesarean section pain. Am J Obstet Gynecol. 1992;167(1):108-109. 
  12. AirCast, Inc. Cryo/Cuff [website]. Summit, NJ: AirCast; 1997. Available at: http://www.aircast.com/products/cryo.htm. Accessed July 26, 2000. 
  13. McDowell JH, McFarland EG, Nalli BJ. Use of cryotherapy for orthopedic patients. Orthoped Nurs. 1994;13(5):21-30. 
  14. Levy AS, Marmar E. The role of cold compression dressings in the postoperative treatment of total knee arthroplasty. Clin Orthoped Rel Res. 1993;297:174-178. 
  15. Mindrebo N, Shelbourne KD. Knee pressure dressings and their effects on lower extremity venous capacitance and venous outflow. Orthopaed Int. 1994;2(3):273-280. 
  16. Shelbourne KD, Stube KC, Patel DV. Conservative treatment of degenerative joint disease of the knee using cold compression therapy. Sports Exercise Injury. 1996;2:176-180. 
  17. Whitelaw GP, DeMuth KA, Demos HA, et al. The use of the Cryo/Cuff versus ice and elastic wrap in the postoperative patients. Am J Knee Surg. 1995;8(1):28-30; discussion 30-31. 
  18. Shelbourne KD, Rubenstein RA, McCarroll JR. Postoperative cryotherapy for the knee in ACL reconstructive surgery. Orthopaed Int. 1994;2(2):165-170. 
  19. Shelbourne KD, Wilckens JH. Current concepts in anterior cruciate ligament rehabilitation. Orthopaed Rev. 1990;19(11):957-964. 
  20. Ohkoshi Y, Ohkoshi M, Nagasaki S, et al. The effect of cryotherapy on intraarticular temperature and postoperative care after anterior cruciate ligament reconstruction. Am J Sports Med. 1999;27(3):357-362. 
  21. van der Heijden G J, van der Windt D A, de Winter A F. Physiotherapy for patients with soft tissue shoulder disorders: A systematic review of randomised clinical trials. BMJ. 1997;315(7099):25-30. 
  22. Klein MJ. Superficial heat and cold. eMedicine J. 2001;12(2). Available at: http://www.emedicine.com/pmr/topic201.htm. Accessed August 1, 2002. 
  23. BREG, Inc.  Polar Care Products [website].  Vista, CA: BREG; 2003. Available at: http://www.bregpolarcare.com. Accessed June 20, 2003.
  24. Philadelphia Panel. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for low back pain. Phys Ther. 2001;81(10):1641-1674.
  25. Philadelphia Panel. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for knee pain. Phys Ther. 2001;81(10):1675-1700.
  26. Philadelphia Panel. Philadelphia Panel evidence-based clinical practice guidelines on selected rehabilitation interventions for neck pain. Phys Ther. 2001;81(10):1701-1717.
  27. Robinson VA, Brosseau L, Casimiro L, et al. Thermotherapy for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2002:(2):CD002826.
  28. Brosseau L, Judd MG, Marchand S, et al. Thermotherapy for treatment of osteoarthritis. Cochrane Database Syst Rev. 2003;(4):CD004522.
  29. Hubbard TJ, Aronson SL, Denegar CR.  Does cryotherapy hasten return to participation: A systematic review. J Athletic Training. 2004;39(1):88-94.
  30. 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 Sports Med. 2004;32(1):251-261.
  31. Martin CW; Workers Compensation Board of British Columbia (WCB) Evidence-based Practice Group. Cryocuffs. Systematic Review. Richmond, BC: Workers Compensation Board of British Columbia (WorksafeBC); 2003.
  32. Warren TA, McCarty EC, Richardson AL, et al. Intra-articular knee temperature changes: Ice versus cryotherapy device. Am J Sports Med. 2004;32(2):441-445.
  33. Lee CK, Pardun J, Buntic R, et al. Severe frostbite of the knees after cryotherapy. Orthopedics. 2007;30(1):63-64.
  34. NHIC, Inc. Local Coverage Determination (LCD) for Cold Therapy (L5038). Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdiction A. Hingham, MA: NHIC; revised January 1, 2011.
  35. NHIC, Inc. Local Coverage Article for Cold Therapy  (A19799). Policy Article. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdiction A. Hingham, MA: NHIC; effective January 2011.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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