Coverage Policy Manual
Policy #: 2018029
Category: Surgery
Initiated: November 2018
Last Review: November 2023
  Continuous Local Anesthetic Infusion Pumps (Disposable Pain Pumps)

Description:
Local delivery of analgesia to operative sites is designed to reduce postoperative pain, while limiting systemic side effects of analgesia. Additional benefits include reduced need for oral narcotics, decreased incidence of breakthrough pain, and faster return to normal activities. These pumps (often disposable elastometric bulb-shaped reservoirs) are filled with analgesics such as ropivicaine or bupivacaine,that are continuously delivered into or around the surgical site via a percutaneous catheter. 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. Pressure from the elastic walls of the reservoir drives the fluid delivery. Elastomeric infusion pumps are designed to deliver drugs for up to 5 days followed by removal of the catheter. Use of elastomeric pumps to deliver local analgesia has been investigated in the following postoperative clinical situations:
 
    • Orthopedic procedures, such as repair of the anterior cruciate ligament
    • Urology procedures, such as prostatectomy
    • Plastic surgery procedures
    • Obstetrical/gynecologic procedures, such as cesarean section
    • Gastrointestinal surgery procedures, such as hemorrhoidectomy or gastric bypass
    • Thoracic surgery procedures, such as thoracotomy
    • Cardiovascular surgery procedures, such as sternotomy
 
 
Regulatory Status
Several disposable 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™ (Halyard Health), (K040337; K063530)
    • C-bloc® and Homepump Eclipse® (all from I-Flow Corporation, Lake Forest, CA),
    • the Stryker® (Stryker, Kalamazoo, MI) and
    • Accufuser™ and DonJoy PCD™ (McKinley Medical, Wheat Ridge, CO).  
    • AutoFuser® Disposable Pain Pump (Teleflex), (K041585)
    • ACTion® Fuser Pain Pump (Ambu), (K0617409)
 
 
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. Product Code: MEB.
 
Note:  These devices have not been cleared by the FDA for intra-articular use (FDA, 2009). According to the FDA label, the adverse event of chondrolysis has been reported following intra-articular infusions of local anesthetics following orthopedic surgical procedures.  (FDA, 2009)  In addition, Adverse Event Reports have also been issued by the FDA for the ON-Q ONDEMAND bolus button failure (FDA, 2017), as well as for other pump systems, including the Stryker pump (FDA, 2010) and the Accufuser pain pump (FDA, 2013), related to leakages.  Additional information, related to chondrolysis associated with intra-articular infusions of local anesthetics using an elastomeric pump following arthroscopic and other surgical procedures, is contained in the FDA labeling for ropivacaine hydrochloride (HCL) injection, USP (Aurobindo Pharma Limited IDA, Pashamylaram, India) and other formulations.  

Policy/
Coverage:
Does Not Meet Primary Coverage Criteria Or Not Medically Necessary For Contracts Without Primary Coverage Criteria
 
Continuous local infusion of analgesia to operative wound sites using an elastomeric infusion pump during the post-operative period does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness as a technique for postoperative pain control.
 
For members with contracts without primary coverage criteria, continuous local infusion of analgesia to operative wound sites using an elastomeric infusion pump during the post-operative period is considered not medically necessary.  Not medically necessary services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
Several randomized, blinded placebo-controlled trials have reported improved pain control and decreased use of systemic opioid pain medications with the use of continuous infusion of analgesics to operative wound sites results in improved pain control and decreased use of systemic opioids (Hoenecke et al, 2002; Givens et al,2002; Cheong et al, 2001; Grider et al, 2012; (Ansaloni, 2007). However, most of these studies were small and the outcomes were not significantly superior.  
 
In addition, although many of the studies demonstrate better post-operative analgesia, variances in the analgesic regimens utilized, the surgical procedures studied and the number of catheters used make it difficult to draw accurate trial results (Forastiere, 2008; Richman, 2006).  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; Schurr, 2004).
 
Polglase et al (2007) reported on a lack of efficacy of a continuous wound infusion of ropivacaine in conjunction with best practice post-operative analgesia after midline laparotomy for major abdominal colorectal surgery.  The investigators performed a randomized, double-blind, placebo-controlled trial on patients presenting for major abdominal colorectal surgery.  Subjects were allocated to receive ropivacaine 0.54 % or normal saline via a dual catheter Painbuster Soaker continuous infusion device into their mid-line laparotomy wound for 72 hours post-operatively.  A total of 310 patients were included in this study.  The investigators found that the continuous wound infusion of ropivacaine after abdominal colorectal surgery conveys minimal benefit compared with saline wound infusion.  There was no statistically significant difference in: pain at rest, morphine usage, length of stay, mobility, nausea, or return of bowel function.  The authors concluded that delivery of ropivacaine to midline laparotomy wounds via a Painbuster Soaker device did not demonstrate any significant clinical advantage over current best practice.
 
Medbery et al (2014) assessed the value of continuous wound infusion systems (CWIS) in patients following laparoscopic Roux-en-Y gastric bypass (LRYGBP) surgery. Records of all consecutive patients who underwent elective LRYGBP by a single surgeon from January 2008 until June 2010 were reviewed.  The presence of CWIS, patient pain scores, PACU times, post-operative narcotic and anti-emetic requirements, post-operative complications, and hospital LOS were recorded.  Clinical data were subsequently linked and correlated with hospital financial data to determine overall hospital costs.  A total of 44 LRYGBP patients were reviewed; 24 (54.5 %) received CWIS for post-operative pain control.  There was no significant difference in PACU times, post-operative LOS, or post-operative complications. Patients with CWIS required significantly less narcotics and anti-emetics. However, patients with CWIS did not report better pain control and had slightly higher hospital costs ($13,627.00 versus $13,395.05, p = 0.68).  The authors concluded that findings from the current study suggested that the value of CWIS for post-operative pain control following LRYGBP is limited.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
A4305Disposable drug delivery system, flow rate of 50 ml or greater per hour
A4306Disposable drug delivery system, flow rate of less than 50 ml per hour
E1399Durable medical equipment, miscellaneous

References: Alford JW, Fadale PD(2003) Evaluation of postoperative bupivacaine infusion for pain management after anterior cruciate ligament reconstruction Arthroscopy 2003; 19(8):855-861

Ansaloni L, Agnoletti V, Bettini D, et al(2007) The analgesic efficacy of continuous elastomeric pump ropivacaine wound instillation after appendectomy J Clin Anesth 2007; 19(4):256-263

Cheong WK, Seow-Choen F, Eu KW et al(2001) Randomized clinical trial of local bupivacaine perfusion versus parenteral morphine infusion for pain relief after laparotomy Br J Surg 2001; 88(3):357-9

Forastiere E, Sofra M, Giannarelli D, et al(2008) Effectiveness of continuous wound infusion of 0.5% ropivacaine by On-Q pain relief system for postoperative pain management after open nephrectomy Br J Anaesth 2008; 101(6):841-847

Givens VA, Lipscomb GH, Meyer NL(2002) A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery Am J Obstet Gynecol 2002; 186(6):1188-91

Grider JS, Mullet TW, Saha SP, Harned ME, Sloan PA(2012) A randomized, double-blind trial comparing continuous thoracic epidural bupivacaine with and without opioid in contrast to a continuous paravertebral infusion of bupivacaine for post-thoracotomy pain J Cardiothorac Vasc Anesth 2012 Feb;26(1):83-9

Medbery RL, Chiruvella A, Srinivasan J, et al(2014) The value of continuous wound infusion systems for postoperative pain control following laparoscopic Roux-en-Y gastric bypass: An analysis of outcomes and cost Obes Surg 2014; 24(4):541-548 PMID: 24421154  

Polglase AL, McMurrick PJ, Simpson PJ, et al(2007) Continuous wound infusion of local anesthetic for the control of pain after elective abdominal colorectal surgery Dis Colon Rectum 2007; 50(12):2158-2167

Richman JM, Liu SS, Courpas G, et al(2006) Does continuous peripheral nerve block provide superior pain control to opioids? A meta-analysis Anesth Analg 2006; 102(1):248-257

Schurr MJ, Gordon DB, Pellino TA, Scanlon TA(2004) Continuous local anesthetic infusion for pain management after outpatient inguinal herniorrhaphy Surgery 2004; 136(4):761-769

U.S. Food and Drug Administration (FDA). (2009) 2009. FDA warns of chondrolysis with continuously infused local anesthetics. November 13, 2009. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm

U.S. Food and Drug Administration (FDA). (2010) 2010. Recall Number Z-2594-2010. Class 2 Device Recall PainPump2 BlockAid Demo. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94303

U.S. Food and Drug Administration (FDA). (2012) 2012: Z-2253-2012 Class 1 Device Recall ONQ pump with ONDEMAND bolus button https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111679

U.S. Food and Drug Administration (FDA). (2013) 2013. Recall Number Z-1679-2013 Class 2 Device Recall FOLFUSOR SV Elastomeric Infusion Devices. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119649


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.