Populations	Interventions	Comparators	Outcomes
Individuals: · With pain and/or swelling after knee surgery	Interventions of interest are: · Cooling device	Comparators of interest are: · Standard icing regimen	Relevant outcomes include: · Symptoms · Functional outcomes · Medication use · Resource utilization
Individuals: · With pain and/or swelling after shoulder surgery	Interventions of interest are: · Cooling device	Comparators of interest are: · Standard icing regimen	Relevant outcomes include: · Symptoms · Functional outcomes · Medication use · Resource utilization
Individuals: · With pain and/or swelling after facial surgery	Interventions of interest are: · Cooling device	Comparators of interest are: · Standard icing regimen	Relevant outcomes include: · Symptoms · Functional outcomes · Medication use · Resource utilization

Background

COLD AND COMPRESSION THERAPY

Use of ice packs and various bandages and wraps following surgery or musculoskeletal and soft tissue injury is common. A variety of manually operated and mechanical continuous cooling devices are commercially available.

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. Circulating 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. Noncirculating 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.

Noncirculating Cooling Devices

The CryoCuff® and Polar Care Cub devices are examples of passive, noncirculating cooling devices. The 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 water drained. The cooler is then raised above the affected limb, and cold water refills the compressive cuff. The 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.

Circulating Cooling Devices

In active, circulating cooling devices, a motorized pump circulates chilled water and may also provide pneumatic compression. For example, the AutoChill® device, which may be used with a CryoCuff, consists of a pump that automatically exchanges water from the cuff to the cooler, eliminating the need for manual water recycling. The Hot/Ice Thermal Blanket is another circulating cooling device. It consists of two 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. The Game Ready™ Accelerated Recovery System is a circulating 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 to provide intermittent pneumatic compression. The Hilotherm® Clinic circulates cooled water through preshaped thermoplastic polyurethane facial masks for use after different types of facial surgery. ThermaZone® provides thermal therapy with pads specific to various joints as well as different areas of the head (front, sides, back, eyes). CTM™ 5000 and cTreatment are computer-controlled devices that provide cooling at a specific (11°C) and continuous temperature.

Regulatory Status

A large number of circulating and noncirculating cooling devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process since 1976. U.S. Food and Drug Administration product code: ILO.

Table 1. Cooling Devices Cleared by the US Food and Drug Administration

Device	Manufacturer	Date Cleared	510(k) No.	Indication
Therma-X, Term-X At, Therm-X Pro Ath	Zenith Technical Innovations	08/03/2018	K181149	To treat post-surgical and acute injuries to reduce swelling and pain
Med4 Elite	Cool Systems, Inc (DBA Game Ready)	09/29/2017	K171685	To treat post-surgical and acute injuries to reduce swelling and pain
Nice1	Nice Recovery Systems, LLC	12/23/2014	K143197	To treat post-surgical and acute injuries to reduce swelling and pain
Dynatron Peltier Thermostim Probe	Dynatronics Corp.	01/24/2014	K132057	To treat post-surgical and acute injuries to reduce swelling and pain

 

Related Policies

• Continuous Passive Motion Device (Policy #017 in the DME Section)

2. Combination circulating cooling and compression (cryopneumatic) devices are considered investigational.


Medicare Coverage:
There is no National Coverage Determination (NCD) for this service. Noridian Healthcare Services, LLC, the Local DME Medicare Carrier for jurisdiction JA, has determined that this service is not covered. For additional information, refer to to Local Coverage Determination (LCD): Cold Therapy (L33735). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33735&ver=8&Date=&DocID=L33735&bc=iAAAABAAAAAAAA%3d%3d&.


[RATIONALE: This policy was created in 1997 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through January 6, 2019.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function - including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

COOLING DEVICE AFTER POST-KNEE SURGERY

Clinical Context and Test Purpose

The purpose of a cooling device is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as a standard icing regimen, in patients with pain and/or swelling after knee surgery.
The question addressed in this policy is: does the use of cooling devices improve the net health outcome in postsurgical patients compared with standard icing regimens?
The following PICOTS were used to select literature to inform this policy.

Patients

The relevant population of interest are individuals with pain and/or swelling after knee surgery.

Interventions

The therapy being considered is a cooling device.

Comparators

Comparators of interest include a standard icing regimen. Treatments include postoperative exercises, NSAIDS, and opioids.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, medication use, and resource utilization.

Timing

The existing literature evaluating a cooling device as a treatment for pain and/or swelling after knee surgery has varying lengths of follow-up, ranging from one to six weeks. While studies described below all reported at least one outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, one to six weeks of follow-up is considered necessary to demonstrate efficacy.

Setting

Patients with pain and/or swelling after knee surgery are actively managed by physical therapists and primary care providers in an outpatient clinical setting.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

a. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
b. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
c. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
d. Studies with duplicative or overlapping populations were excluded.

Schroder and Passler (1994) compared the CryoCuff device with ice therapy in 44 patients who had undergone repair of the anterior cruciate ligament (ACL).^1, Those receiving ice therapy administered an ice bag three times a day postoperatively. While those randomized to the CryoCuff groups reported significant decreases in pain, swelling, and analgesic use, it is not clear whether icing three times a day is a typical icing regimen.

Whitelaw et al (1995) reported on results of a trial that randomized 102 patients undergoing knee arthroscopy in the outpatient setting to a CryoCuff device or traditional ice therapy.^2, 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 (1994) reported 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).^3, No data were provided on the number of ice pack exchanges, although the water was recirculated in the CryoCuff device every one to four hours.

Edwards et al (1996) studied the outcomes of 71 patients undergoing ACL reconstruction who were randomized to CryoCuff therapy with ice water, CryoCuff therapy with room temperature water, or no cold therapy.^4, Therefore, this trial did not include the relevant control group of patients treated with conventional ice packs. Another randomized trial by Brandsson et al (1996) suffers from the same limitation; in this study of 50 patients undergoing ACL repair, no group received standard therapy with ice packs.^5, Levy and Marmar (1993) compared the outcomes of a trial that randomized 80 patients (100 knees) undergoing TKA with noncirculating cold therapy with a CryoCuff device or to no cold therapy.^6, Although the CryoCuff group reported a significant decrease in blood loss and a mild decrease in analgesic requirements, this trial did not include the relevant control group.

Table 2. Summary of Key RCT Characteristics

Study	Countries	Sites	Dates	Participants	Interventions
					Active	Comparator
Schroder et al (1994)	EU	NR	NR	Patients undergoing ACL reconstruction using autologous patellar tendon graft	CC (n=21)	ICE (n=23)
Whitelaw (1995)	US	NR	NR	Patients undergoing diagnostic knee arthroscopy	CC (n=56)	ICE with elastic bandages (n=46)

RCT: randomized controlled trial; NR: not reported; CC: CryoCuff; ICE: standard ice packs; ACL: anterior cruciate ligament.

Table 3. Summary of Key RCT Results

Study	Range of Motion between Groups	Pain Score between Groups	Average Pain Assessment, 24 hrs; 72hrs	Pain Medication Usage over 24 hr Period, Day 1; 2; 3
Schroder et al (1994)	p=0.0001-0.0177	p-0.01
Whitelaw (1995)
CC			4.34; 3.15	4.23; 3.21; 2.7
ICE			4.98; 3.58	5.00; 4.22; 3.12

RCT: randomized controlled trial; CC: CryoCuff; ICE: standard ice packs

Table 4. Relevance Gaps

Study	Population a	Intervention b	Comparator c	Outcomes d	Follow-Up e
Schroder et al (1994)
Whitelaw (1995)					1,2 Follow-up was only 72 hrs post-surgery

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3.  Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements;
5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.
 

Table 5. Study Design and Conduct Gaps

Study	Allocation a	Blinding b	Selective Reporting c	Follow-Up d	Power e	Statistical f
Schroder et al (1994)	1. Randomization not described	1,2,3. Not blinded
Whitelaw (1995)	1. Randomization method did not produce groups of equal numbers (56 vs 46 patients)	1,2,3. Not blinded

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3.  Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions;
6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient;
3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.
 

Circulating Cooling Devices

In the largest study to date, Thienpont (2014) evaluated 116 patients who had undergone TKA who were assigned in a quasi-randomized order to 8 hours of daily advanced cryotherapy at a fixed temperature or to the application of cold packs for 15 minutes after each of 2 physical therapy sessions.^7, Both groups could apply cryotherapy during the evening and night whenever they wanted for comfort and pain control. Thirty percent of patients in the advanced cryotherapy group did not use the device at night due to excessive noise. Primary outcomes were visual analog scale (VAS) pain scores at rest and during deep active knee flexion, walking without aid, and analgesic use. Secondary outcomes were knee range of motion, active straight-leg raising, walking without aid, swelling, visual hematoma, and length of stay. There were no significant differences between groups in VAS scores, need for analgesics, or any of the secondary outcomes. There was a significant decrease in flexion at 6 weeks in the advanced cryotherapy group (114°vs 120°).

Woolf et al (2008), in an RCT of 60 patients, compared a temperature-controlled cryotherapy device with a standard icing regimen following outpatient knee arthroscopy.^8, Both groups were instructed to apply the treatment for 20 minutes every 2 hours during waking hours for the first 4 days after surgery. All night, the cooling device group was instructed to use the device throughout the first four nights, whereas the control group was advised to use ice packs as needed. No differences in daytime pain were observed between 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 was significant only for postoperative day 2 (36% vs 6%; p=0.04). Additional study with a larger number of patients is needed to determine whether the use of continuous cooling at night improves health outcomes.

More recently, an RCT of 47 participants by Rufilli et al (2015) compared 2 homogenous groups of patients with ACL reconstruction to evaluate the efficacy of a continuous cold flow device (10°-30°C) relative to conventional crushed ice bags (intervention group n=23, control group n=24).^9, All patients were discharged the day after surgery. Primary endpoints included: knee pain (using the numeric rating scale that ranged from 0 [no pain] to 10 [worst pain]); blood loss; measures of knee swelling at 3 sites (patellar apex, 10 cm proximal to the superior patellar pole, 15 cm distal to the superior patellar pole); knee range of motion; and the use of pain medicine. Relative to the control, the intervention group had a significant reduction in numeric rating scale pain scores (p<0.001) and a significant decrease in blood loss (p<0.001). Knee volume was also significantly lower in the intervention group at the patellar apex (p=0.013) and 10 cm proximal to the superior patellar pole (p=0.001). Although there was a significant increase in mean flexion (p<0.001) for the intervention group relative to the control, there was no difference between groups in the use of pain medication. No adverse events were reported in either group postoperatively, or related to the use of the cooling device or the ice bags. Researchers noted several limitations to the trial, including small sample size, lack of blinding, and lack of evaluation of longer term efficacy after hospital discharge.

Rufilliet al (2017) investigated the use of the continuous-flow cold device in an RCT of 50 patients with end-stage knee osteoarthritis after primary TKA who had the same rehabilitation program and pain-relieving strategy.^10, The intervention group (n=24) received the continuous-flow cold device (10° and 30°C) and the control group (n=26) received crushed ice bags postoperatively. There were no statistically significant differences between groups in terms of subjective pain scores (using a numeric rating scale), medication use, or knee circumference. In addition, there were no statistically significant differences in blood loss, need for transfusion, or range of motion. However, there was a nonsignificant trend at day seven toward a lesser increase in knee circumference in the intervention group. Reported limitations included small sample size, lack of blinding, lack of evaluation of longer term efficacy after hospital discharge, and no skin temperature evaluation. Compared with a traditional icing regimen, the use of a continuous-flow cold device was no better than traditional icing in patients with TKA.

Several randomized studies have compared circulating cooling devices with no cold therapy and therefore are not relevant to this policy.^11,12,13,14,

Table 6. Summary of Key RCT Characteristics

Study	Countries	Sites	Dates	Participants	Interventions
					Active	Comparator
Woolf (2008)	US	1	NR	Patients receiving outpatient knee arthroscopy	Continuous temperature-controlled cryotherapy system (n=24)	Traditional ice therapy regimen (n=29)
Thienpont (2014)	EU	1	2012	Patients receiving primary knee arthroplasty for osteoarthritis	Advanced cryotherapy (n=58)	Cold packs (n=58)
Rufilli (2015)	EU	NR	NR	Patients undergoing ACL reconstruction	Continuous cold flow device (Hilotherm; n=23)	Ice bags (n=24)
Rufilli (2017)	EU	1	2013-2014	Patients affected by end-stage knee osteoarthristis and treated with primary TKA	Continuous cold flow device (Hilotherm; n=24)	Crushed ice packs (n=26)

RCT: randomized controlled trial; TKA: total knee arthroplasty; NR: not reported; ACL: anterior cruciate ligament.

Table 7. Summary of Key RCT Results

Study	Patients with Mild1 Pain Intensity	Mean VAS at Rest2 Days Post-Surgery	Pain Evaluation Scores2 1 Day Post-Surgery	Pain Evaluation Scores2 7 Days Post-Surgery	Blood Loss
Woolf (2008)
Device	35.7%
Ice	5.9%
p-value	0.04
Thienpont (2014)
Device		4+3
Ice		3.5+2.5
p-value		0.1842
Rufilli (2015)
Device			0.9+8		26.7+27.3ml
Ice			2.4+1.7		108.0+91.4ml
p-value			<0.001		<0.001
Rufilli (2017)
Device			2.6+1.8	2.0+1.6	242.9+225.1ml
Ice			3.5+2.3	1.6+1.5	230.3+216.5ml
p-value			0.2	0.3	0.8

RCT: randomized controlled trial; VAS: visual analog scale; ICE: standardice packs
1 Mild defined as “did not awaken” due to pain.
2 Pain evaluated using a numeric rating scale ranging from 0, no pain, to 10, worst pain imaginable.

Table 8. Relevance Gaps

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Follow-Upe
Woolf (2008)
Thienpont (2014)		2. Version used unclear
Rufilli (2015)					1.2, Follow-up was limited to the duration of patients' hospital stay
Rufilli (2017)					1,2. Follow-up duration was 7 days

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3.  Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements;
5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 9.  Study Design and Conduct Gaps

Study	Allocationa	Blindingb	Selective Reportingc	Follow-Upd	Powere	Statisticalf
Woolf (2008)	2. Allocation not concealed	1,2,3. No blinding
Thienpont (2014)	1. Randomization not described	1,2. Patients and physicians not blinded		1. 30% lost to follow-up
Rufilli (2015)	2. Allocation not concealed	1,2,3. No blinding
Rufilli (2017)	2. Allocation not concealed	1,2,3. No blinding

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3.  Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions;
6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient;
3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Combination Circulating Cooling and Compression (Cryopneumatic) Devices

Several RCTs and a case-control study have assessed the cryopneumatic devices in the outpatient setting.

Systematic Reviews

A systematic review by Gatewood et al (2017) identified 25 studies evaluating various devices used after arthroscopic knee surgery; of these studies, 8 assessed cryotherapy as a potential treatment to relieve postoperative pain, reduce blood loss, and decrease the use of narcotics, among other outcomes.^15, Several studies compared the efficacy of a cold compression device with that of icing alone, while other studies compared a cold compression device with a control of no cold or compression. Findings were mixed across the studies, with four reporting a significant improvement in pain relief in the cold compression group over the control (p<0.05 and p<0.02), and four reporting no significant difference between the groups. This review was limited by its inclusion of small studies and some variability in its methodology; also most studies had a relatively short follow-up period (<6 weeks), indicating a gap in long-term observation. Reviewers concluded that, compared with a traditional icing regimen, cold compression devices seemed to be superior at relieving postoperative pain; however, the same comparison was inconclusive between cold compression devices and compression alone.

Randomized Controlled Trials

In a multicenter RCT, Su et al (2012) compared 280 TKA patients treated with the Game Ready cryopneumatic device or with ice packs plus static compression.^16, On hospital discharge, 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 score for pain, range of motion, 6-minute walk test, Timed Up & Go test, or knee girth under this more typical icing regimen. Narcotic consumption decreased from 680 to 509 mg morphine equivalents over the first 2 weeks (14 mg less per day), and patient satisfaction increased with the cryopneumatic device.

Waterman et al (2012) reported on an RCT of the Game Ready device in 36 patients who had ACL reconstruction.^17, Patients were instructed to use ice or the cryopneumatic device for 30 minutes at least 3 times a day and return to the clinic at 1, 2, and 6 weeks postoperatively. Compliance during the first 2 weeks did not differ significantly between groups (100% for Game Ready vs 83% for icing). The primary outcome measure (VAS pain score) differed at baseline, limiting interpretation of the results. There were no significant differences between the groups for knee circumference, the Lysholm Knee Score, 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%).

Table 10. Summary of Key RCT Characteristics

Study	Countries	Sites	Dates	Participants	Interventions
					Active	Comparator
Su (2012)	US, Australia	11	NR	Patients with unilateral osteoarthritis	Cryopneumatic device (n=103)	Ice with static compression (n=84)
Waterman (2012)	US	1	NR	Patients undergoing ACL reconstruction	Compressive cryotherapy (n=18)	Conventional ice pack therapy (n=18)

RCT: Randomized controlled trials; NR: not reported; ACL: anterior cruciate ligament.

Table 11. Summary of Key RCT Results

Study	Decrease 1 in 6 Minute Walk Test at 2 and 6 Weeks Post-Surgery	Flexion at 2 and 6 Weeks Post-Surgery	Extension at 2 and 6 Weeks Post-Surgery	Discontinuation of Pain Medication at 6 weeks
Su (2012)
Device	-118.2m	-33.0	1.5
Ice	-107.7m	-28.7	1.6
Waterman (2012)
Device				15/18 (83.3%) patients
Ice				5/18 (27.8%) patients
p=value				0.0008

RCT: randomized controlled trial; ICE: standard ice packs.
1Decrease from preoperative values.

Table 12. Study Design and Conduct Gaps

Study	Allocationa	Blindingb	Selective Reportingc	Follow-Upd	Powere	Statisticalf
Su (2012)	2. Allocation known by operating surgeon and patient
Waterman (2012)	2. Allocation not concealed	1,2,3. Not blinded

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3.  Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers;
5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient;
3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.
 

Nonrandomized Studies

Murgier et al (2017) conducted a prospective case-control study of the Game Ready device, comparing 43 individuals (27 men, 16 women) recovering from revision TKA; the control group (n=19) was treated with a cold pack applied intermittently (4 hours daily), while the Game Ready group was treated with 2, 8-hour cycles in 30 minute off-on increments.^18, While the main outcome was the reduction of total blood loss, a secondary outcome was postoperative pain, as measured by VAS three days postsurgery. Patients using the Game Ready device showed decreased blood loss compared with the control group (260 mL vs 465 mL; p<0.05), as well as an improvement in postoperative pain (VAS score, 1 vs 3; p<0.05). Limitations included the possibility of a type II error due to the specialized surgical unit where the study was performed; additional limitations (eg, variability of results, concerns about patients’ comorbidities) affected the study’s secondary outcomes. The authors concluded that, overall, the cryopneumatic device aided patients’ recovery from revision TKA but additional prospective randomized trials would be needed to confirm results.

Section Summary: Post-Knee Surgery

For individuals who have pain and/or swelling after knee surgery, the evidence includes a systematic review, several RCTs, and a case-control study. Evidence on manually operated passive noncirculating cooling devices is limited by the control condition used in the trials. Studies that used either a no-icing control or infrequent ice applications did not provide sufficient evidence of comparative efficacy. Other studies provided no information on the frequency of ice changes, limiting interpretation of the results. Randomized trials comparing active circulating cooling devices with standard intermittent icing or cold packs have had mixed results, with several studies reporting a significant reduction in medication use or other outcomes (eg, pain, blood loss, swelling, range of motion) and others finding no significant improvements in outcomes. The results also differ across patient populations. A case-control study of the Game Ready device found that the device decreased postoperative blood loss and reduced postoperative pain, compared with intermittent application of a cold pack. However, it is unclear whether constant cooling provides greater pain relief than standard icing or intermittent use of the device. The systematic review included studies with a control of icing, as well as studies with a control of no cold or compression alone, concluding that combined cooling and compression is superior to traditional icing in relieving pain; however, the review did not report on the efficacy of specific devices.

COOLING DEVICE AFTER POST-SHOULDER SURGERY

Clinical Context and Therapy Purpose

The purpose of a cooling device is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as a standard icing regimen, in patients with pain and/or swelling after shoulder surgery.
The question addressed in this policy is: does the use of cooling devices improves the net health outcome in postsurgical patients compared with standard icing regimens?
The following PICOTS were used to select literature to inform this policy.

Patients

The relevant population of interest are individuals with pain and/or swelling after shoulder surgery.

Interventions

The therapy being considered is a cooling device.

Comparators

Comparators of interest include a standard icing regimen. Treatments include postoperative exercises, NSAIDS, and opioids.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, medication use and resource utilization.

Timing

The existing literature evaluating a cooling device as a treatment for pain and/or swelling after shoulder surgery has varying lengths of follow-up, ranging from seven to ten days. While studies described below all reported at least one outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, seven to ten days of follow-up is considered necessary to demonstrate efficacy.

Setting

Patients with pain and/or swelling after shoulder surgery are actively managed by physical therapists and primary care providers in an outpatient clinical setting.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

a. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
b. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
c. To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
d. Studies with duplicative or overlapping populations were excluded.

Kraeutler et al (2015) compared the Game Ready shoulder wrap with standard icing in an RCT of 46 patients who had undergone rotator cuff repair or subacromial decompression.^19, The average age at the time of surgery was 55.4 years in the compressive cryotherapy intervention group (n=25) and 55.8 years in the control group (n=21; p=0.91).Patients were instructed to apply the cryotherapy every other hour for the first three days and two to three times a day until the follow-up visit at seven to ten days. In the immediate postoperative week (days 0-7)participants used diaries to document pain level using a VAS score (no pain to extreme pain) twice per day. They also reported use of pain medication (converted to morphine equivalent dosage).Analysis of patient diaries showed no significant differences in average pain, worst pain, and morphine equivalent dosage between the two groups on any day during the week after surgery. Post hoc power analysis showed that 13 patients per group would provide sufficient power to detect a 25 mm (out of 100 mm) difference in VAS scores between the 2 groups. Trial limitations included small sample size (noting that 11 [19%] of enrolled patients were excluded due to noncompliance), lack of blinding, potential recall bias due to the use of patient-reported diaries, and uncertainty whether the correct usage of cryotherapy was followed.

Noyes et al (2018) published an RCT comparing continuous cryotherapy (CC; Polar Care) and standard ice packs (ICE) as a means of improving postoperative pain control for patients undergoing a primary or revision shoulder arthroplasty procedure^20,. Forty patients (20 in each group), from 30 to 90 years old, were randomly assigned to the 2 treatments. VAS pain scores were similar for both the CC and ICE groups preoperatively (5.9 vs 6.8; p=0.121) and postoperatively at 24 hours (4.2 vs 4.3; p=0.989), 3 days (4.8 vs 4.7; p=0.944), 7 days (2.9 vs 3.3; p=0.593), and 14 days (2.5 vs 2.7; p=0.742). CC and ICE did not differ significantly in the number of morphine equivalents of pain medication postoperatively at 24 hours (43 vs 38 mg; p=0.579), 3 days (149 vs 116 mg; p=0.201), 7 days (308 vs 228 mg; p=0.181), or 14 days (431 vs 348 mg; p=0.213). VAS for quality of sleep was not different between CC and ICE postoperatively at 24 hours (5.1 vs 4.3; p=0.382), 3 days (5.1 vs 5.3; p=0.601), 7 days (6.0 vs 6.7; p=0.319), or 14 days (6.5 vs 7.2; p=0.348). The study was limited by patient compliance not being measured objectively, all patients receiving a single-shot interscalene block, and final outcomes not being evaluated.

Section Summary: Post-Shoulder Surgery

One RCT found that, for patients undergoing shoulder arthroscopy for rotator cuff repair or subacromial decompression, the use of compressive cryotherapy produced no significant reductions in pain or medication use compared with the standard ice wrap.

COOLING DEVICES AFTER POST-FACIAL SURGERY

Clinical Context and Test Purpose

The purpose of a cooling device is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as a standard icing regimen, in patients with pain and/or swelling after facial surgery.
The question addressed in this policy is: does the use of cooling devices improves the net health outcome in postsurgical patients compared with standard icing regimens?
The following PICOTS were used to select literature to inform this policy.

Patients

The relevant population of interest are individuals with pain and/or swelling after facial surgery.

Interventions

The therapy being considered is a cooling device.

Comparators

Comparators of interest include a standard icing regimen. Treatments include postoperative exercises, NSAIDS, and opioids.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, medication use, and resource utilization.

Timing

The existing literature evaluating a cooling device as a treatment for pain and/or swelling after facial surgery has varying lengths of follow-up, ranging from one to six weeks. While studies described below all reported at least one outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, one to six weeks of follow-up is considered necessary to demonstrate efficacy.

Setting

Patients with pain and/or swelling after facial surgery are actively managed by physical therapists and primary care providers in an outpatient clinical setting.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

a. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
b. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
c. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
d. Studies with duplicative or overlapping populations were excluded.

Several studies have been reported by a research group that compared the Hilotherm device with cooling compresses. In a randomized trial, Rana et al (2013) assessed 32 patients with postoperative swelling of bilateral mandibular fractures using a cooling mask around the head and jaw.^21, Swelling was reduced for the cooling mask group on day one, two, and three after surgery. VAS scores for pain were also reduced for the cooling mask group, compared with day 1 (3.87 vs 5.53) and day 2 (3.63 vs 6.31). There were no significant differences between groups for a postoperative neurologic score, trismus, or mandibular dysfunction. Earlier research by Rana et al (2011) randomized 30 patients scheduled for third molar surgery to a water circulating cooling face mask (Hilotherm; n=15) or cool compresses (control, n=15).^22, The intervention group had significantly less facial swelling (72.2 mL) relative to the control group (96.6 mL) on postoperative day 2 (p=0.005). This trend was maintained at day 10 (intervention, 23.3 mL; control, 46.7 mL, p<0.001). There was also a significantly lower pain score in the intervention group relative to the control group on both postoperative day 2 (intervention, 3.4; control, 4.8; p<0.05) and day 3 (intervention, 2.9; control, 3.7; p<0.05). Both the intervention and the control groups had a significant decrease in the neurologic score on day ten compared with day two but there were no significant differences between groups in the neurologic score.Compared with immediately after surgery, both groups had a significant increase in mouth opening on postoperative day two. At postoperative day 28, there were no differences between the groups with regard to facial swelling, pain score, or neurologic score. The authors did not report study limitations. However, it should be noted the study had a small sample size and used observer-blinding only. In a pilot study, Rana et al (2011) found that the use of the cooling device in patients scheduled for treatment of bilateral mandibular fractures also reduced postoperative swelling and pain relative to the traditional cooling regimen.^23, But there were no significant benefits with regard to mandible functioning, mouth opening, or neurologic scores.

A similar study design was reported by Modabber et al (2013), who treated 42 patients for unilateral zygomatic fractures.^24, Patients were randomized to a water circulating continuous cooling face mask, the Hilotherm device, (n=21), or conventional cooling (n=21) postoperatively. Three-dimensional optical scans were recorded postoperatively. On postoperative days 1, 2, and 3, respectively, there were significant decreases in swelling with the intervention relative to control (intervention, 9.45 mL; control, 20.69 mL; p<0.001; intervention, 13.20 mL; control, 22.97 mL; p<0.001; intervention, 14.44 mL; control, 23.52 mL; p=0.002). This trend was maintained on day 7 (p=0.019). After 28 days, there were no significant differences between groups. Pain analysis conducted using a VAS, ranging from 0 (no pain) to 10 (maximum pain), was reported before surgery and postoperatively. There were significant increases in pain in the control group relative to the intervention during postoperative day 1 (intervention, 2.38; control, 4.10; p=0.001) and day 2 (intervention, 2.34; control, 4.38; p<0.001). However, there were no significant differences in pain between groups by day seven. Nerve dysfunction, reported on a 9-point scale (9 being the worst) and assessed pre- and postoperatively, showed a significant reduction in the neurologic score in the intervention group (2.57) relative to the control (3.90) at day 1 (p=0.008), with no significant differences between the groups at days 7, 28, and 90 postoperatively. On postoperative day 1, there was a significant (p=0.050) reduction in eye motility limitation in the intervention group (n=17 with no limitation; n=4 with limitation) relative to the control (n=11 with no limitation; n=10 with limitation). There were also significantly fewer patients in the intervention group with diplopia (n=18 without diplopia, n=3 with diplopia) compared with the control group (n=11 without diplopia, n=10 with diplopia; p=0.019). There were no statistically significant differences in eye motility limitation or diplopia between the groups on days 7 and 28. Overall patient satisfaction was significantly higher in the intervention group (1.43) relative to the control (2.29; p<.001). In addition to the small sample size, trial limitations included observer-only blinding and that the 3-dimensional optical scans used only measured localized facial swelling.

Section Summary: Post-Facial Surgery

Several small RCTs and a pilot study of patients receiving cooling therapy found significant decreases in facial swelling and pain. However, there were mixed results in terms of the intervention’s efficacy in reducing neurologic problems as well as improving eye motility, diplopia, mandible functioning, and mouth opening compared with conventional cooling regimens. Several of the trials had observer-only blinding.

Summary of Evidence

For individuals who have pain and/or swelling after knee surgery who receive a cooling device, the evidence includes systematic reviews, several RCTs, and a case-control study. The relevant outcomes are symptoms, functional outcomes, medication use, and resource utilization. Evidence on manually operated passive noncirculating cooling devices is limited by the control condition used in the trials. Studies that used either a no-icing control or infrequent ice applications do not provide sufficient evidence of comparative efficacy. Other studies have provided no information on the frequency of ice changes, limiting interpretation of the results. Several randomized trials have compared active circulating cooling devices with standard intermittent icing or cold packs, and two of the larger trials found no significant benefit of the continuous cooling devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have pain and/or swelling after shoulder surgery who receive a cooling device, the evidence includes an RCT. The relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. Evidence found that use of compressive cryotherapy produced no significant reduction in pain or medication use compared with the standard ice wrap. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have pain and/or swelling after facial surgery who receive a cooling device, the evidence includes several small RCTs and a pilot study. The relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. There have been mixed results regarding the intervention’s efficacy in reducing neurologic problems as well as improving eye motility, diplopia, mandible functioning, and mouth opening compared with conventional cooling regimens. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Clinical Input 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.

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.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 13.

Table 13. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT02426515	Cryotherapy to Improve Outcomes in Lower Third Molar Surgery (COOL)	60	Dec 2017 (ongoing)

NCT: national clinical trial.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Cooling Devices Used in the Outpatient Setting
Cold Compression Therapy Devices
AutoChill Device
Cryo Cuff Device
Polar Care Device
Game Ready
CRYOPress
Hot/Ice Thermal Blanket
CTM 5000
cTreatment

References:

1. Schroder D, Passler HH. Combination of cold and compression after knee surgery. A prospective randomized study. Knee Surg Sports Traumatol Arthrosc. Jan 1994;2(3):158-165. PMID 7584198.

2. 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. Winter 1995;8(1):28-30; discussion 30-21. PMID 7866800.

3. 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.

4. 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. Mar-Apr 1996;24(2):193- 195. PMID 8775119.

5. Brandsson S, Rydgren B, Hedner T, et al. Postoperative analgesic effects of an external cooling system and intra-articular bupivacaine/morphine after arthroscopic cruciate ligament surgery. Knee Surg Sports Traumatol Arthrosc. Jan 1996;4(4):200-205. PMID 9046503.

6. 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.

7. 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.

8. 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. Jan 2008;21(1):15-19. PMID 18300666.

9. Ruffilli A, Buda R, Castagnini F, et al. Temperature-controlled continuous cold flow device versus traditional icing regimen following anterior cruciate ligament reconstruction: a prospective randomized comparative trial. Arch Orthop Trauma Surg. Oct 2015;135(10):1405-1410. PMID 26141535.

10. Ruffilli A, Castagnini F, Traina F, et al. Temperature-controlled continuous cold flow device after total knee arthroplasty: a randomized controlled trial study. J Knee Surg. Sep 2017;30(7):675-681. PMID 27903009.

11. Barber FA, McGuire DA, Click S. Continuous-flow cold therapy for outpatient anterior cruciate ligament reconstruction. Arthroscopy. Mar 1998;14(2):130-135. PMID 9531122.

12. 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. May-Jun 1989;17(3):344-349. PMID 2729484.

13. 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. Jun 1998;27(6):403-406. PMID 9617725.

14. Saito N, Horiuchi H, Kobayashi S, et al. Continuous local cooling for pain relief following total hip arthroplasty. J Arthroplasty. Apr 2004;19(3):334-337. PMID 15067647.

15. Gatewood CT, Tran AA, Dragoo JL. The efficacy of post-operative devices following knee arthroscopic surgery: a systematic review. Knee Surg Sports Traumatol Arthrosc. Feb 2017;25(2):501-516. PMID 27695905.

16. 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.

17. Waterman B, Walker JJ, Swaims C, et al. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. May 2012;25(2):155-160. PMID 22928433.

18. Murgier J, Cailliez J, Wargny M, et al. Cryotherapy with dynamic intermittent compression improves recovery from revision total knee arthroplasty. J Arthroplasty. Sep 2017;32(9):2788-2791. PMID 28465126.

19. 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. Jun 2015;24(6):854-859. PMID 25825138.

20. Noyes MP, Denard PJ. Continuous Cryotherapy vs Ice Following Total Shoulder Arthroplasty: A Randomized Control Trial. Am J Orthop (Belle Mead NJ). 2018 Jun;47(6). doi: 10.12788/ajo.2018.0045. PubMed PMID: 29979799.

21. 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.

22. Rana M, Gellrich NC, Ghassemi A, et al. Three-dimensional evaluation of postoperative swelling after third molar surgery using 2 different cooling therapy methods: a randomized observer-blind prospective study. J Oral Maxillofac Surg. Aug 2011;69(8):2092-2098. PMID 21496998.

23. Rana M, Gellrich NC, Joos U, et al. 3D evaluation of postoperative swelling using two different cooling methods following orthognathic surgery: a randomised observer blind prospective pilot study. Int J Oral Maxillofac Surg. Jul 2011;40(7):690-696. PMID 21411291.

24. 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. Jul 29 2013;14:238. PMID 23895539.

25. The Health Plan. Durable Medical Equipment (DME) Medical Policies. 2016; https://www.healthplan.org/sites/default/files/documents/resources/DME/DME_fullmanual_121316.pdf. Accessed March 13, 2018.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

E0218
E0236