Clinical UM Guideline
|Subject:||Continuous Local Delivery of Analgesia to Operative Sites using an Elastomeric Infusion Pump during the Post-Operative Period|
|Guideline #:||CG-DME-09||Current Effective Date:||01/14/2014|
|Status:||Reviewed||Last Review Date:||11/14/2013|
This clinical UM guideline addresses the use of the elastomeric infusion pump as a means of local delivery of analgesia to operative sites during the post-operative period. These pumps are designed to reduce post-operative pain, while limiting the systemic side effects of analgesia.
This document does not address the use of infused analgesia or anesthesia during an operative procedure.
Not Medically Necessary:
Continuous local delivery of analgesia to operative sites using an elastomeric infusion pump during the post-operative period is considered not medically necessary as a technique of postoperative pain control.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|No separate specific procedure code for insertion of a disposable drug delivery system|
|A4305||Disposable drug delivery system, flow rate of 50 ml or greater per hour|
|A4306||Disposable drug delivery system, flow rate of less than 50 ml per hour|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2014]|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2014]|
Local delivery of analgesia to operative sites is designed to reduce postoperative pain, while limiting systemic side effects of analgesia. Drug delivery can be regulated through the use of simple, disposable, elastomeric pumps filled with analgesics that are attached to a variety of catheters that provide continuous delivery of the drug to the surgical site. Catheters may contain multiple openings, so that the drug seeps into the operative wound all along its length, similar in concept to a "soaker" hose. Elastomeric infusion pumps are designed to deliver drugs for up to five days followed by removal of the catheter.
Use of elastomeric pumps to deliver local analgesics has been investigated, to date, by studies that were primarily case series and other small studies of the following postoperative clinical situations:
Evaluation of the medical necessity of continuous delivery of local analgesia using elastomeric pain pumps requires additional, well designed, large studies to determine and validate the role of these devices in the realm of postoperative pain management. While several randomized studies have reported reductions in narcotic requirements, most of these studies were small and failed to demonstrate statistically significant, superior clinical outcomes, in terms of reductions in need for opioid pain medications (Allen, 2009; Banerjee, 2008; Bray, 2007; Chen, 2010; Coghlan, 2009; Heller, 2008; Hoenecke, 2002; Kazmier, 2008; Nechleba, 2005; Oakley, 1998). Variances in the surgical procedures studied and the number of catheters utilized further confound the available trial results (Forastiere, 2008). Additional small studies have been insufficiently powered to demonstrate improvements from the local analgesic technique in all key outcome variables, such as time to endotracheal extubation, time to intensive care unit (ICU) discharge, etc. (Chiu, 2008; White, 2003). In addition, a placebo-related beneficial effect has been noted in studies of local infusion of analgesics to multiple surgical sites (Alford and Fadale, 2003; Baroody, 2004; Schurr, 2004). A meta-analysis was conducted by Richman which evaluated data from available randomized controlled trials to determine the efficacy of perineural catheters for reducing postoperative pain, opioid-related side effects, (e.g., nausea, vomiting, sedation) and opioid use, compared with opioid analgesia alone. The level of individual satisfaction was also assessed. Although the results showed better postoperative analgesia from use of the perineural catheters, compared to opioids (p < 0.001) for all catheter locations and time periods (p < 0.05), lack of consistency was noted in the analgesic regimens reviewed across the various included trials (Richman, 2006).
Another study reported on a continuous wound infusion of ropivacaine in conjunction with best practice postoperative analgesia after midline laparotomy for abdominal colorectal surgery. The investigators performed a randomized, participant and outcome assessor-blinded, placebo-controlled trial on subjects presenting for major abdominal colorectal surgery. Subjects were allocated to receive ropivacaine 0.54 percent or normal saline via a dual catheter continuous infusion device into their midline laparotomy wound for 72 hours postoperatively. A total of 310 trial participants were included in this study. The investigators found that the continuous wound infusion of ropivacaine after abdominal colorectal surgery conveyed minimal benefit, compared with saline wound infusion with no statistically significant difference for: pain at rest, morphine usage, length of stay, mobility, nausea, or return of bowel function. There was a small, statistically significant difference in mean pain on movement on day 1 for the ropivacaine group (adjusted mean difference -0.6 [range, -1.08 to -0.13]). The investigators reported that, although this trend continued on days 2 and 3, the differences between groups were no longer statistically significant. The investigators concluded that delivery of ropivacaine to midline laparotomy wounds did not demonstrate any significant clinical advantage over current best practice (Polglase, 2007).
A single-institution, prospective, randomized, double-blinded study of 96 post-appendectomy subjects sought to evaluate the analgesic efficacy and safety of ropivacaine (0.2%), when administered continuously via elastomeric pump. Study subjects were randomly assigned into two groups: 500 mg of ropivacaine in 48 hours (10 mL of 0.2% ropivacaine 20 mg, starter dose plus 5 mL/h continuous wound infusion via elastomeric pump device; n = 48) in the experimental group and 250 mL of normal saline, as placebo, in the control group. Postoperative pain was measured either with a simple verbal scale or with a visual analog scale; also parenteral analgesic consumption and global satisfaction scores were measured. A reduction in postoperative pain was observed in the ropivacaine group. The perceived degree of pain was assessed with a simple verbal scale measurement of severe and unbearable, with findings which were significantly lower in the ropivacaine group than in the normal saline group from time 0 to 24 hours at rest and from time 0 to 36 hours on coughing. Significantly lower pain intensity (visual analog scale) was found in the ropivacaine group both at rest and on coughing, beginning at three hours and continuing to 36 hours postoperatively (p < 0.05), and the mean number of rescue analgesic doses was significantly lower in the ropivacaine group (p < 0.001). There were no statistically significant differences in the frequency of adverse events between the two groups. The authors concluded that wound instillation with ropivacaine 0.2% is a useful, practical, and safe method for management of postoperative pain after appendectomy (Ansaloni, 2007).
Several elastomeric pumps and associated catheters have received clearance through the U.S. Food and Drug Administration (FDA) 510(k) approval process as Class II devices. FDA-approved devices include, but are not limited to, the ON-Q®, PainBuster™, C-bloc® and Homepump Eclipse® (all from I-Flow Corporation, Lake Forest, CA), as well as the Stryker® (Stryker, Kalamazoo, MI) and Accufuser™ (McKinley Medical, Wheat Ridge, CO). FDA labeling indicates that these devices are generally intended for continuous and/or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. The devices are "Intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic-only pain management" (FDA, 2004). Several versions include individual-controlled bolus dosing features, which allow for the delivery of fixed bolus dose volumes of medication at fixed time intervals. Approved routes of administration are intraoperative, (for example, soft tissue, body cavity), perineural and percutaneous. The devices have not been FDA approved for intra-articular use (FDA, 2009).
On November 13, 2009 the FDA issued a safety alert regarding 35 reports of chondrolysis (necrosis and destruction of cartilage) in individuals given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. According to the FDA Alert:
The significance of this injury to otherwise healthy young adults warrants notification to health care professionals. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Chondrolysis was diagnosed within a median of 8.5 months after the infusion. Almost all of the reported cases of chondrolysis (97%) occurred following shoulder surgeries. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the affected individuals required additional surgery, including arthroscopy or arthroplasty (joint replacement). It is not known which specific factor or combination of factors contributed to the development of chondrolysis in these cases. The infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis. It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years without any reported occurrence of chondrolysis. Healthcare professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery. Based on the reported cases of chondrolysis, following continuous intra-articular infusion with local anesthetics, the FDA is requiring the drug manufacturers to update their product labels to warn healthcare professionals about this potential serious adverse effect. FDA is also exploring possible options for addressing the safety issues with the infusion devices (e.g., labeling changes, etc.). (FDA information has not been updated since 2010 and is provided for reference purposes only; the information states that it might be outdated.)
On May 8, 2012 the FDA announced a Class I recall of the I-Flow ON-Q pump with ONDEMAND bolus button which was voluntarily recalled by the manufacturer, I-Flow Corporation (Lake Forest, CA), due to a flaw in the bolus button locking mechanism. The recall stated, "While no injuries or adverse events have been reported, use of a pump with this condition may result in over medication of the patient and may potentially result in serious patient injury." According to the FDA, "Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death" (FDA, 2012). The manufacturer claims to be working to resolve this flaw in the pump mechanism. Adverse Event Reports have been issued by the FDA for the I-Flow PainBuster infusion pump system related to chondrolysis of the shoulder (FDA, 2009), as well as for other pump systems, including the Stryker pump (FDA, 2008) and the Accufuser pain pump (FDA, 2011), related to leakages.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Continuous Local Delivery of Analgesia to Operative Sites Using an Elastomeric Infusion Pump
On-Q Post Op Pain Relief System
Pain Buster Pain Management System
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Reviewed||11/14/2013||Medical policy & Technology Assessment Committee (MPTAC) review. No change to stance. The Discussion section and References were updated.|
|Reviewed||11/08/2012||MPTAC review. No change to stance. References were updated.|
|Reviewed||11/17/2011||MPTAC review. No change to stance. References were updated.|
|Revised||11/18/2010||MPTAC review. The title and position statement have been revised to clarify that this document addresses delivery of analgesia during the post-op period. No other change to stance. The Discussion section and References were updated.|
|Reviewed||11/19/2009||MPTAC review. No change to stance. References were updated.|
|Reviewed||11/20/2008||MPTAC review. No change to stance. Discussion section and References were updated.|
|Revised||11/29/2007||MPTAC review. The clinical UM guideline stance has not changed (considered not medically necessary). However, the statement has been revised to remove reference to "surgeries typically requiring oral or parenteral narcotics for pain relief." References were updated.|
|Reviewed||12/07/2006||MPTAC annual review. References updated, no change to guideline stance.|
|Revised||12/01/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number|
|08/15/2003||UMR.015||Intralesional and Intra-articular Pain Management|
|Anthem Southeast||03/08/2005||1191||Pain Management Systems (Pain Buster, On-Q System, Stryker Pain Pump)|
|WellPoint Health Networks, Inc.||09/23/2004||5.01.05||Continuous Local Delivery of Analgesia to Operative Sites Using an Elastomeric Infusion Pump|