BlueCross and BlueShield of Montana Medical Policy/Codes
Delivery of Anesthesia for Postoperative Pain Control by Continuous Infusion Using Elastomeric Infusion Pump
Chapter: Surgery: Procedures
Current Effective Date: December 27, 2013
Original Effective Date: December 27, 2013
Publish Date: September 27, 2013
Description

The number and complexity of surgical procedures performed on an outpatient basis has been increasing as hospital admissions have been decreasing in recent years. Postoperative pain, nausea, and vomiting are the most frequent complications associated with delays in hospital discharge and unplanned admission following ambulatory surgery. In addition, patients who have had procedures frequently experience moderate to severe pain at home that cannot be controlled by prescription oral opioids: therefore, a postoperative infusion pump may be considered to control the patient’s pain. Some infusion pumps are designed mainly for stationary use at a patient’s bedside. Others, called ambulatory infusion pumps, are designed to be portable or wearable.

An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. Infusion pumps are also utilized to deliver antibiotics, chemotherapy drugs, and pain relievers. Infusion pumps are in widespread use in clinical settings such as hospitals, and in the home environment. Infusion pumps offer advantages over manual administration of fluids, including the ability to deliver fluids in very small volumes, and the ability to deliver fluids at precise rates or automated intervals (1)

Different types of infusion pumps have different fluid-control mechanisms, which may be powered electrically or mechanically. Some infusion pumps are operated by a trained user, who programs the rate and duration of fluid delivery. In a syringe infusion pump, for example, fluid is held in the reservoir of a syringe, and a moveable piston controls fluid delivery. In a peristaltic pump, a set of rollers pinches down on a length of flexible tubing, pushing fluid forward. Some complex infusion pumps are capable of delivering fluids from multiple reservoirs at multiple rates. (1)

Anesthetic agents can be delivered directly into the skin incision site or wound bed, intra-articular or intrabursal sites (e.g., knee or shoulder), or bone wounds (e.g., iliac crest graft sites). Anesthetic drug delivery can be regulated through the use of simple disposable elastomeric pumps, filled with anesthetic agents, such as Ropivacaine or Bupivacaine, and attached to a catheter that provides continuous delivery of the drug to the desired site at a very low infusion rate. In an elastomeric infusion pump, fluid is held in a stretchable balloon reservoir, and pressure from the elastic walls of the balloon drives fluid delivery. The catheters have multiple openings similar to a “soaker hose” that allows the drug to seep into the wound along its length. These pumps are designed to deliver drugs for up to five days followed by the removal of the catheter. Some of these pumps also allow patient-controlled boluses when needed. (2)

Policy

Each benefit plan or contract defines which services are covered, which are excluded, and which are subject to dollar caps or other limits.  Members and their providers have the responsibility for consulting the member's benefit plan or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan or contract, the benefit plan or contract will govern.

Coverage

Elastomeric infusion pumps for intralesional (use of a pain pump in a surgical wound and/or  surgical joint) and intraarticular administration of analgesics for postoperative pain control for surgeries that typically require oral and parental narcotics for pain relief is considered experimental, investigational, and/or unproven.

Examples of trade names of elastomeric pumps include, but are not limited to: 

  1. Pain Buster™ Pain Management System,
  2. On-Q Soaker™ catheter delivery system,
  3. Infusor System™,
  4. On-QR Post Op Pain Relief.

Policy Guidelines

When a disposable pump (such as the elastomeric pump) is placed during an inpatient or outpatient surgical procedure for management of postoperative pain, the cost of the supply (disposable pump) should be an itemized part of the facility reimbursement, and should not be billed separately as Durable Medical Equipment. 

The correct HCPCS code for a disposable pump (such as the elastomeric pump) is A4306.  Code E0781 is a non-disposable infusion pump that is usually rented, not purchased, and is not to be used for billing disposable elastomeric pumps.

If a non-disposable pump is used for short-term control of postoperative pain, administration of medication, etc., at home and/or after discharge following a surgical procedure, a daily rental should be billed using the –KR modifier (for “rental item partial month) for the outpatient rental days.

Rationale

Intralesional studies

In 2008, Polglase et al. completed an assessor blinded, random controlled study (RCT) over a 3 year period. The study involved 310 patients and compared ropivacaine verses saline infusion with a PainBuster pump after abdominal colorectal surgery. The study determined that the continuous wound infusion of ropivacaine after abdominal colorectal surgery conveyed minimal benefit compared with saline wound infusion. There was 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. This trend continued on days 2 and 3, but the differences between the groups were no longer statistically significant. It was determined that the delivery of ropivacaine to midline laparotomy wounds via a PainBuster Soaker device did not demonstrate any significant clinical advantage over current best practice. (3)

Karthiesalingam et al., in 2008 evaluated the continuous wound infusion of local anesthetic agents following colorectal surgery. This was a systematic review and metaanalysis of 542 post laparotomy patients. The results suggest that local anaesthetic wound infusion following colorectal surgery (laparotomy) is a promising technique, but it does not provide conclusive evidence of benefit. Further research is required including a cost-effectiveness analysis. (4)

In 2009, Coghlan et al., completed a randomized, participant and outcome assessor blinded, placebo controlled study that examined the safety and effectiveness of ropivacaine infusion after arthroscopic or mini-incision rotator cuff surgery. The use of alternative analgesia, delay in discharge, and adverse events, including development of shoulder pain, infection, and leakage, were also assessed. A total of 84 participants received arthroscopic decompression (43 in the placebo arm and 45 in the ropivacaine arm) and 70 received rotator cuff repair (35 participants in each treatment arm). Compared with placebo, ropivacaine infusion resulted in a significant but clinically unimportant improvement in average pain in the first 12 hours following both procedures. There was no difference between groups with regard to the amount of oral analgesia used. No difference was detected between groups with regard to the prevalence of nausea and vomiting, catheter leakage, delayed discharge, or stiff painful shoulder, and no subject in either group developed postoperative infection. Coglan concluded that there was minimal evidence to support the use of ropivacaine infusion for improving outcomes following rotator cuff surgery in the setting of preemptive ropivacaine and intra-operative parecoxib. (5)

In 2011, Baulig et al. studied the continuous elastomeric pump wound instillation after open abdominal aortic surgery: The study was a double-blind, placebo-controlled study that quantified the impact of continuous wound infusion with ropivacaine and morphine administration and subjective pain relief in 15 patients. The patients received either ropivacaine or saline by an elastomeric pump after surgery. The study was terminated prematurely due to a malfunction of the elastomeric balloon pump resulting in toxic serum levels of total ropivacaine in 2 patients on the second postoperative day. In conclusion, continuous wound infusion of ropivacaine using an elastomeric system was not reliable and did not improve postoperative pain control in patients after open abdominal aortic surgery. (6)

Intraarticular studies

In 2010, Anderson et al., researched chondrolysis of the glenohumeral joint after infusion of bupivacaine through an intra-articular pain pump catheter: This was a retrospective chart review of 18 cases. Patients presented with complaints of a stiff, painful shoulder and the examination revealed decreased range of motion of the affected shoulder. Radiographs and magnetic resonance imaging (MRI) showed joint space narrowing, as well as subchondral sclerosis and cyst formation. The study determined that all 18 patients were diagnosed with glenohumeral joint chondrolysis after use of an intra-articular pain pump catheter (IAPPC). Of the 18 patients, 14 had repeat arthroscopic procedures, and 5 received humeral head-resurfacing. Anderson and colleagues could not establish a causal link for the glenohumeral chondrolysis but felt the development may be related to the intra-articular infusion of bupivacaine with epinephrine the patients received post operatively. Thus, they caution against the use of IAPPCs. (7)

Chen et al., in 2010 evaluated continuous intra-articular infusion of bupivacaine for postoperative pain relief after total hip arthroplasty Chen wanted to determine if bupivacaine via infusion pumps enhanced and sustained analgesia. This was a randomized, placebo-controlled, double-blind study. A total of 92 participants undergoing total hip replacements were randomized to receive continuous intra-articular infusion of either 0.5 % bupivacaine or 0.9 % normal saline for 48 hours. The primary outcome measure was pain intensity on visual analog scale (VAS) scores, time to first rescue dose of narcotics, amount of narcotic use, presence of adverse events, length of hospital stay, and hip function were evaluated with the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Despite a longer time to first narcotic rescue (56 versus 21 mins, p < 0.0001) in patients receiving bupivacaine, the 2 groups did not differ significantly in overall pain relief (p = 0.54). A lower VAS score was found only at time 0 and 2 hours; no difference in VAS score was noted at any other time point. Additionally, there was no difference in terms of the amount of narcotic use, incidence of adverse events, hospitalization days, and the WOMAC score. The study determined that continuous intra-articular infusion of 0.5 % bupivacaine at 2 ml/hr via a PCIP does not provide sustained postoperative pain relief in patients undergoing total hip arthroplasty. (8)

Federal Drug Administration (FDA)

In 2009, the FDA released a document that indicated adverse outcomes with the use of continuous intra-articular infusions of local anesthetics to control post-surgical pain. It reinforced that local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia, but neither local anesthetic nor infusion devices are approved or indicated for continuous intra-articular infusion and to avoid use of these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgeries. (9)  In 2010, the FDA reviewed 35 reports of chondrolysis in patients who received continuous intra-articular infusions of local anesthetics with elastomeric infusion devices (pain pumps) for postoperative pain management. The local anesthetics involved bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, and ropivacaine with and without epinephrine. The FDA stated that the significance of this injury to otherwise healthy young adults warrants notification to health care professionals. The FDA is requiring the drug manufacturers to update their product labels to warn healthcare professionals about this potential serious adverse effect. It is also exploring possible options for addressing the safety issues with the infusion devices. (10). The FDA created the Infusion Pump Improvement Initiative with the goal of establishing additional requirements for infusion pump manufacturers, proactively facilitate device improvements, and increase user awareness in order to address infusion pump problems and support the safe use of the devices. (1)

Professional Societies/Organizations

In 2010 the American Academy of Orthopedic Surgeons (AAOS) guidelines for rotator cuff states, “We cannot recommend for or against the use of an indwelling subacromial infusion catheter for pain management after rotator cuff repair as there is a lack of compelling evidence resulting in an unclear balance between benefits/potential harm”. (11)

In 2013, the AAOS) reevaluated the merits of continuous infusion pumps using local anesthetics, particularly bupivacaine. Although continuous infusion systems offer a certain degree of convenience, the ideal delivery system and agent for intra-articular infusions have yet to be defined. Surgeons who have previously used intra-articular continuous infusion pumps and those who may be considering their use should be aware of the risks and complications related to these devices/medications when used in the management of postoperative pain in selected arthroscopic procedures. In addition, surgeons should be aware of the FDA labeling of these devices. Pain is often the first sign of an impending complication, and continuous infusion of local anesthetics into a surgical site may mask that warning. Single stick peripheral nerve blocks are also capable of masking important “warning” pain and should be used only when appropriate, such as when postoperative compartment syndrome is unlikely to develop. (12)

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

ICD-9 Codes

Refer to the ICD-9-CM manual.

Procedural Codes: 64416, 64446, 64448, 64450, A4305, A4306, E0781
References
  1. FDA – Infusion Pump Improvement Initiative. U.S. Food and Drug Administration Center for Devices and Radiologic Health (2010). Available at http://www.fda.gov  (accessed 10/2013).
  2. Continuous local delivery of anesthesia to operative sites using an elastomeric infusion pump- Archived Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual. (2003 March) Surgery: 7.01.94.
  3. Polglase AL, et al. Continuous wound infusion of local anesthetic for the control of pain after elective abdominal colorectal surgery. Dis Colon Rectum 2007; 50(12): 2158-2167.
  4. Karthiesalingam, A., et al. Continuous wound infusion of local anaesthetic agents following colorectal surgery; Systemic review and metaanalysis. World Journal of Gastroenterology (2008 September), XII, volume14 ;( 34); 5301-5305. 
  5. Coghlan Jennifer A., et al. Efficacy of subacromial ropivacaine infusion for rotator cuff surgery: A randomized trial. The Journal of Bone and Joint Surgery (2009); 91:1558-1567.
  6. Baulig, W., et al. Continuous elastomeric pump-based ropivacaine wound instillation after open abdominal aortic surgery: How reliable is the technique? Heart Surg Forum. 2011; 14(1): E51-E58.
  7. Anderson SL., et al. Chondrolysis of the glenohumeral joint after infusion of bupivacaine through an intra-articular pain pump catheter: A report of 18 cases. Arthroscopy. 2010; 26(4): 451-461.
  8. Chen DW., et al. Continuous intra-articular infusion of bupivacaine for post-operative pain relief after total hip arthroplasty: A randomized, placebo-controlled, double-blind study. Eur J Pain.2010; 14(5): 529-534.
  9. FDA – U.S. Food and Drug Administration – Chondrolysis reported with Continuously Infused local Anesthetics: marked as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine (2009) Available at http://www.fda.gov (accessed 2013 August 29).
  10. FDA – U.S. Food and Drug Administration: Chondrolysis linked to Intra-articular Infusions. Nursing 2010, June, Issue 6, Volume 60. Available at www.fda.gov American Academy of Orthopedic Surgeons (AAOS): Optimizing the Management of Rotator Cuff problems. Volume (1.1); XII, (accessed September 16,2013).
  11. American Academy of Orthopedic Surgeons (AAOS): Treatment of Osteoarthritis of The Knee- Evidence-Based Guideline, 2nd edition (2013). Available at www.eurekalert.org (accessed September 16, 2013).
History
September 2013  New 2013 BCBSMT medical policy.
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Delivery of Anesthesia for Postoperative Pain Control by Continuous Infusion Using Elastomeric Infusion Pump