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 Kinex ThermoComp Device, the TEC Thermoelectric Cooling System (an iceless cold compression device), the VascuTherm2, 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.

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/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.

According to the manufacturer, the Kinex ThermoComp™ Device provides 3 separate pre-programmed therapies that are activated by a push of a button: (i) cold-compression, (ii) contrast-compression, and (iii) intermittent pneumatic compression for DVT prophylaxis.  Continuous cold is delivered by a solid-state system without ice.  Cold temperature is microprocessor-controlled within 1° making this one of the safest devices for unsupervised use in a patient's home.  Contrast therapy cycles every 30 mins with cold at 49° for 20 mins followed by heat at 105° for 10 mins.  Intermittent compression is delivered distal-to-proximal through a segmented pad.  Deep vein thrombosis prophylaxis is delivered from a rapid inflation pump at 50 mm Hg through a calf pad or 100 mm Hg through a foot pad.  All 3 therapies are delivered separately, however cold-compression and DVT compression can run at the same time with the device cycling DVT compression separate from limb compression.  The Kinex ThermoComp™ Device is intended to treat post-operative injuries in the home, to reduce edema and pain, to improve blood flow to the surgical site, and to provide DVT prophylaxis therapy for high-risk patients.  http://www.kinexmedical.com/thermocomp.html.  However, there is a lack of evidence regarding the safety and effectiveness of this device.

According to the manufacturer, the VascuTherm2 solid state device provides heat, cold (without ice), compression, and/or DVT prophylaxis therapy.  The system is pre-programmed per written physician's instructions for fully automatic, safe, trouble-free use in the patient's home.  It is indicated for pain, edema, and DVT prophylaxis for the post-operative orthopedic patient.  The precisely controlled temperature range of 43 degrees F to 105 degrees F insures against frost-bite or burns.  Therapy times are also pre-programmed to insure maximum patient compliance.  It is extremely easy for patients to set up and use.  http://www.calamarimedical.com/VascuTherm2.html.  However, there is a lack of evidence regarding the safety and effectiveness of this device.

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.