Notification



Notification Issue Date:



Medical Policy Bulletin


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

Policy #:01.00.09c

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


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.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

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.

Because 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.

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.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for the continuous local delivery of anesthesia to operative sites.

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 (e.g., sternotomy)
  • Gastrointestinal surgical procedures (e.g., gastric bypass, hemorrhoidectomy)
  • Obstetrical/gynecological procedures (e.g., Cesarean section)
  • Orthopedic surgeries (e.g., repair of the anterior cruciate ligament)
  • Thoracic surgery procedures (e.g., thoracotomy)
  • Urological procedures (e.g., prostatectomy)

References


Ali A, Sundberg M, Hansson U, et al. Doubtful effect of continuous intraarticular analgesia after total knee arthroplasty: a randomized double-blind study of 200 patients. Acta Orthop. 2015;86(3):373-7.

American Society of Anesthesiologists. Practice guidelines for acute pain management in the perioperative setting. Anesthesiology. 2004;100(6):1573-1581.

American Society of Anesthesiologists. Practice guidelines for acute pain management in the perioperative setting. An updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012; 116(2):248-273.

Andrews V, Wright JT, Zakaria Fet al. Continuous infusion of local anaesthetic following laparoscopic hysterectomy--a randomised controlled trial. BJOG. 2014;121(6):754-60; discussion 761.

Apelt N, Schaffzin J, Bates C, et al. Surgical site infection related to use of elastomeric pumps in pectus excavatum repair. Lessons learned from root cause analysis. J Pediatr Surg. 2017;52(8):1292-1295.

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.

Chandon M, Bonnet A, Burg Y, et al. Ultrasound-guided Transversus Abdominis plane block versus continuous wound infusion for post-caesarean analgesia: a randomized trial. PLoS One. 2014;9(8):e103971.

Chaudhry A, Hallam S, Chambers A, et al. Improving postoperative pain management in subpectoral tissue expander implant reconstruction of the breast using an elastomeric pump. Ann R Coll Surg Engl. 2015;97(5):364-8.

Cheong WK, Seow-Choen F, Eu KW, et al. 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.

Fassoulaki A, Vassi E, Korkolis D, et al. Perioperative continuous ropivacaine wound infusion in laparoscopic cholecystectomy: a randomized controlled double-blind trial. Surg Laparosc Endosc Percutan Tech. 2016;26(1):25-30.

Fibla JJ, Molins L, Mier JM, et al. A randomized prospective study of analgesic quality after thoracotomy: paravertebral block with bolus versus continuous infusion with an elastomeric pump. Eur J Cardiothorac Surg. 2015;47(4):631-5.

Fiorelli A, Izzo AC, Frongillo EM, et al. Efficacy of wound analgesia for controlling post-thoracotomy pain: a randomized double-blind study. Eur J Cardiothorac Surg. 2016;49(1):339-47.

Fuzaylov G, Kelly TL, Bline C, et al. Post-operative pain control for burn reconstructive surgery in a resource-restricted country with subcutaneous infusion of local anesthetics through a soaker catheter to the surgical site: Preliminary results. Burns. 2015;41(8):1811-1815.

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 April 2, 2018.

Jones JS, Cotugno RE, Singhal NR, et al. Evaluation of dexmedetomidine and postoperative pain management in patients with adolescent idiopathic scoliosis: conclusions based on a retrospective study at a tertiary pediatric hospital. Pediatr Crit Care Med. 2014;15(6):e247-52.

Kenes MT, Leonard MC, Bauer SR, et al. Liposomal bupivacaine versus continuous infusion bupivacaine via an elastomeric pump for the treatment of postoperative pain. Am J Health Syst Pharm. 2015;72(23 Suppl 3):S127-32.

Kim MH, Shim YH, Kim MS, et al. The efficacy of elastomeric patient-control module when connected to a balloon pump for postoperative epidural analgesia: A randomized, noninferiority trial. Medicine (Baltimore). 2017;96(2):e5828.

Klasen F, Bourgoin A, Antonini F, et al. Postoperative analgesia after caesarean section with transversus abdominis plane block or continuous infiltration wound catheter: A randomized clinical trial. TAP vs. infiltration after caesarean section. Anaesth Crit Care Pain Med. 2016;35(6):401-406.

Lalmand M, Wilwerth M, Fils JF, et al. Continuous ropivacaine subfascial wound infusion compared with intrathecal morphine for postcesarean analgesia: a prospective, randomized controlled, double-blind study. Anesth Analg. 2017;125(3):907-912.

LeBlanc KA, Bellanger D, Rhynes VK, et al. 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.

Noridian Healthcare Solutions, LLC. A52507: External infusion pumps (article). [Noridian Healthcare Solutions, LLC Web site]. Original: 10/01/2015. (Revised 07/11/2017). Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52507&ver=35&Cntrctr=389&name=&DocType=Active&DocStatus=Active&ContrVer=1&CntrctrSelected=389*1&s=9&LCntrctr=139*1&bc=AhAAAAMAAAAA&. Accessed April 25, 2008.

Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD). L33794: External infusion pumps. [Noridian Healthcare Solutions, LLC Web site]. Original: 10/01/2015. (Revised 07/11/2017). Available at: https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD. Accessed April 4, 2018.

Samimi DB, Erb MH, Perry AC, et al. On-Q pump for pain control after orbital implant surgery. Ophthal Plast Reconstr Surg. 2014;30(5):396-9.

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

Saporito A, Calciolari S, Ortiz LG, et al. A cost analysis of orthopedic foot surgery: can outpatient continuous regional analgesia provide the same standard of care for postoperative pain control at home without shifting costs? Eur J Health Econ. 2016;17(8):951-961.

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

US Food and Drug Administration. What Is an Infusion Pump? Last Updated: 12/13/2017. Accessed on April 2, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. AutoFuser Elastomeric Infusion Pump. 510(k) summary. [FDA Web site]. 05/30/06. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060258.pdf. Accessed April 2, 2018

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. ON-Q Pump. 510(k) summary. [FDA Web site]. 01/26/07. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063530.pdf. Accessed April 2, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. PainBuster Infusion System. 510(k) summary. [FDA Web site]. 05/28/98. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K980558.pdf. Accessed April 2, 2018.

Weisman RS, Missair A, Pham P, et al. Accuracy and consistency of modern elastomeric pumps. Reg Anesth Pain Med. 2014;39(5):423-8.

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.





Coding

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.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

This service is not eligible for separate reimbursement for all diagnoses.


HCPCS Level II Code Number(s)



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 Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 01.00.09c:
06/06/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on the Continuous Local Delivery of Anesthesia to Operative Sites Using an Elastomeric Infusion Pump.


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 01/28/2015
Version Issued Date: 01/28/2015
Version Reissued Date: 06/06/2018

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