Medical Policies Online - Policy #: 01.00.09b

Medical Policy Bulletin

Title:

Continuous Local Delivery of Anesthesia to Operative Sites Using an Elastomeric Infusion Pump

Policy #:

01.00.09b

The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate the medical necessity criteria for continuous local delivery of anesthesia to operative sites using an elastomeric infusion pump.

For information on policies related to this topic, refer to the Cross References Table in this policy.

Description:

The medical community has recognized the importance of pain management in routine patient care. In 1995, the American Pain Society declared pain to be the fifth vital sign and established pain management as a critical area of focus for patient care. Postoperative pain is of particular concern to both surgeons and patients following surgery. The effective relief of pain in surgical patients is essential for an earlier discharge from the hospital and for a smoother return to activities of daily living. Patients routinely receive opioids, supplemental analgesia, and/or systemic analgesia for pain management. The goal of postoperative pain management is to reduce or eliminate pain and discomfort with minimum side effects. Analgesia side effects may include nausea, vomiting, dizziness, constipation, and respiratory distress. Planning for pain management typically begins in the preoperative phase of surgery.

Surgeons have recently begun delivering analgesia locally to operative sites using a method that is designed to reduce postoperative pain while limiting the side effects of systemic analgesia. A continuous, regulated flow of local anesthetic (such as ropivacaine or bupivacaine) is delivered to the operative site through a specially designed catheter, which is placed intraoperatively. The catheter may contain multiple openings along its length that allow the anesthetic to seep into, and distribute equally in, the operative wound. The catheter is connected to an elastomeric infusion pump and is designed to deliver drugs for up to five days, followed by removal of the catheter by either the patient or the surgeon. Elastomeric infusion pumps are generally for single use and are disposable. Additional benefits include the reduced need for postoperative oral narcotics, a decreased incidence of breakthrough pain, and a faster transition to normal activities of daily living.

Elastomeric infusion pumps that deliver local analgesia have been used postoperatively for procedures such as, but not limited to, the following:

Cardiovascular surgical procedures (eg, sternotomy)
Gastrointestinal surgical procedures (eg, gastric bypass, hemorrhoidectomy)
Obstetrical/gynecological procedures (eg, cesarean section)
Orthopedic surgeries (eg, repair of the anterior cruciate ligament)
Thoracic surgery procedures (eg, thoracotomy)
Urological procedures (eg, prostatectomy)

Policy

Continuous local delivery of anesthesia to operative sites using an elastomeric infusion pump is considered medically necessary and, therefore, covered as a technique for postoperative pain management for surgeries that require oral or parenteral narcotics for pain management.

As the elastomeric infusion pump (Healthcare Common Procedure Coding System codes A4305 and A4306) is a supply provided by the facility, ambulatory surgery center, or surgical procedure unit, reimbursement is considered part of the global fee for the surgery.

Reimbursement for the insertion and removal of elastomeric catheters for local delivery of anesthesia to operative sites is included in the surgical procedure.

Guidelines

Surgical procedures that do not require oral or parenteral narcotics for pain management should not require the use of an elastomeric infusion pump.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, continuous local delivery of anesthesia to operative sites using an elastomeric infusion pump is covered under the medical benefits of the Company's products when the medical necessity criteria listed in the medical policy are met.

MEDICARE

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved several elastomeric infusion pumps for the continuous local delivery of anesthesia to operative sites. Examples include the following devices:

The PainBuster� Elastomeric Infusion Pump (I-Flow Corporation, Lake Forest, CA), which was approved by the FDA on May 28, 1998
The AutoFuser Elastomeric Infusion Pump (Algos Therapeutics, St. Paul, MI), which was approved by the FDA on August 26, 2004
The ON-Q Post-Op Pain Relief System™( I-Flow Corporation, Lake Forest, CA), which was approved by the FDA on January 26, 2007.

References

Capdevila X, Macaire P, Aknin P, et al. Patient-controlled perineural analgesia after ambulatory orthopedic surgery: a comparison of electronic versus elastomeric pumps. Anesth Analg. 2003;96(2):414-417.

Cheong WK, Seow-Choen F, Eu KW, Tang CL, Heah SM. Randomized clinical trial of local bupivacaine perfusion versus parenteral morphine infusion for pain relief after laparotomy. Br J Surg. 2001;88(3):357-359.

Dowling R, Thielmeier K, Ghaly A, et al. Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. J Thorac Cardiovasc Surg. 2003;126(5):1271-1278.

Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 2002;186(6):1188-1191.

Hoenecke HR Jr, Pulido PA, Morris BA, Fronek J. The efficacy of continuous bupivacaine infiltration following anterior cruciate ligament reconstruction. Arthroscopy. 2002;18(8):854-858.

I-Flow Corporation. The ON-Q� PainBuster� Post-Op Pain Relief System. [I-Flow Web site]. Available at: http://www.iflo.com/prod_painbuster.php. Accessed March 24, 2009.

LeBlanc KA, Bellanger D, Rhynes VK, Hausmann M. Evaluation of continuous infusion of 0.5% bupivacaine by elastomeric pump for postoperative pain management after open inguinal hernia repair. J Am Coll Surg. 2005;200(2):198-202.

Leong WM, Lo WK, Chiu JW. Analgesic efficacy of continuous delivery of bupivacaine by an elastomeric balloon infusor after abdominal hysterectomy: a prospective randomised controlled trial. Aust N Z J Obstet Gynaecol. 2002;42(5):515-518.

Oakley MJ, Smith JS, Anderson JR, Fenton-Lee D. Randomized placebo-controlled trial of local anaesthetic in day-case inguinal hernia repair. Br J Surg.1998;85(6):797-799.

Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995;274(23):1874-1880.

Sanchez B, Waxman K, Tatevossian R, Gamberdella M, Read B. Local anesthetic infusion pumps improve postoperative pain after inguinal hernia repair: a randomized trial. Am Surg. 2004;70(11):1002-1006.

Skryabina EA, Dunn TS. Disposable infusion pumps. Am J Health Syst Pharm. 2006;63(13):1260-1268.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. AutoFuser Elastomeric Infusion Pump. 510(k) summary. [FDA Web site]. 08/26/04. Available at: http://www.fda.gov/cdrh/pdf4/k041585.pdf. Accessed March 24, 2009.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. ON-Q Post Op Pain Relief System. 510(k) summary. [FDA Web site]. 01/26/07. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063530.pdf. Accessed April 1, 2009.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. PainBuster Elastomeric Infusion Pump. 510(k) summary. [FDA Web site]. 05/28/98. Available at: http://www.fda.gov/cdrh/pdf/k980558.pdf. Accessed March 24, 2009.

White PF, Rawal S, Latham P, et al. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003;99(4):918-923.

Zahnd D, Aebi S, Rusterholz S, Fey MF, Borner MM. A randomized crossover trial assessing patient preference for two different types of portable infusion-pump devices. Ann Oncol. 1999;10(6):727-729.

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code System	Code Number(s) and Narrative(s)
CPT	N/A
ICD Procedure	N/A
ICD Diagnosis	This service is not eligible for separate reimbursement for all diagnoses.
HCPCS Level II	THE FOLLOWING CODES ARE NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT 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

Revenue Codes	N/A

Cross References

Cross Reference Policies

11.15.03e:

Insertion of Implantable Infusion Pumps

Version Effective Date: 04/20/2007