Continuous Local Delivery of Analgesia to Operative Sites Using an Elastomeric Infusion Pump
DESCRIPTION
Local delivery of analgesia to operative sites is designed to reduce postoperative pain, while limiting systemic side effects of analgesia. The intended benefits for this treatment also include reduced need for oral narcotics, decreased incidence of breakthrough pain, and faster return to normal activities.
An elastomeric infusion pump regulates the delivery of the drug. The pump is filled with analgesics, which are delivered continuously into the operative wound similar to the concept of a soaker hose.
Examples of FDA approved elastomeric pumps and associated catheters include, but are not limited to, GoBlock™ System, Infusor System™, On-Q® Post Op Pain Relief System, On-Q Soaker™ catheter delivery system, and the Pain Buster™ Pain Management System Infuser.
POLICY
Continuous local delivery of analgesia to operative sites using an elastomeric infusion pump for the treatment of postoperative pain control is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Continuous local delivery of analgesia to operative sites using an elastomeric infusion pump, for any other reason, is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Continuous local delivery of analgesia to operative sites using an elastomeric infusion pump for the treatment of postoperative pain control is considered medically appropriate if ALL of the following criteria are met:
Use is for 72 hours or less
Used following surgeries typically requiring oral or parenteral narcotics for pain control
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
No controlled studies were found in the published literature that validate the application of continuous local delivery of analgesia to operative sites using an elastomeric infusion pump for uses other than that stated in the policy statement. In addition, the FDA issued a warning in 2009, regarding the use of elastomeric pumps for the continuous infusion of local anesthetics. The FDA has not approved any infusion device with the indication for use in intra-articular infusion of local anesthetics.
SOURCES
Ansaloni, L., Agnoletti, V., Bettini, D., Caira, A., Calli, M., Catena, F., et al. (2007). The analgesic efficacy of continuous elastomeric pump ropivacaine wound instillation after appendectomy. Journal of Clinical Anesthesia, 19 (4), 256-263. (Level 2 Evidence - Independent study)
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2003). Continuous local delivery of analgesia to operative sites using an elastomeric infusion pump (7.01.94). Retrieved September 9, 2011 from BlueWeb. (4 articles and/or guidelines reviewed)
Capdevila, X., Dadure, C., Bringuier, S., Bernard, N., Biboulet, P., Gaertner, E., et al. (2006). Effect of patient-controlled perineural analgesia on rehabilitation and pain after ambulatory orthopedic surgery: A multicenter randomized trial. Anesthesiology, 105 (3), 566-573. (Level 2 Evidence - Independent study)
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Infusion pumps (NCD 280.14, p. 2-222, 2-224). Ingenix.
Little, K., Pillai, A., Fazzi, U, & Storey, N. (2007). Local anaesthetic infusion with elastomeric pump after arthroscopic subacromial decompression. Annals of the Royal College of Surgeons of England, 89 (4), 410-413. (Level 3 Evidence)
Pu, L. L., & Plastic Surgery Educational Foundation DATA Committee. (2006). The use of a pain pump for optimal postoperative pain management. Plastic and Reconstructive Surgery, 117 (6), 2066-2069.
Remerand, F., Vuitton, A. S., Palud, M., Buchet, S., Pourrat, X., Baud, A., et al.. (2008). Elastomeric pump reliability in postoperative regional anesthesia: A survey of 430 consecutive devices. International Anesthesia Research Society, 107 (6), 2079-2084.
U. S. Food and Drug Administration. (2006, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062457. Retrieved October 1, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062457.pdf.
U. S. Food and Drug Administration. (2009, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090300. Retrieved October 1, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090300.pdf.
U. S. Food and Drug Administration. (2009, November). Center for Devices and Radiological Health. MedWatch The FDA Safety Information and Adverse Even Reporting Program. Local anesthetics, continuously infused (marketed as bupivacain, chlorprocaine, licocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis. Retrieved September 12, 2011 from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm.
ORIGINAL EFFECTIVE DATE: 12/1/2004
MOST RECENT REVIEW DATE: 10/13/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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