Latest Review Date: August 2023

Category: Surgery                                                                 

POLICY:

Implantable infusion pumps may be considered medically necessary when used to deliver drugs having FDA approval for this route of access and for the related indication for the treatment of:

• Severe, chronic, intractable pain (intravenous, intrathecal, and epidural injection of opioids) following a successful temporary trial of opioid or non-opioid analgesics by the same route of administration as the planned treatment. A successful trial is defined as greater than 50% reduction in pain following implementation of treatment; (excludes headache or head pain, Refer to policy #314)
• Severe spasticity of cerebral or spinal cord origin in patients who are unresponsive to or who cannot tolerate oral baclofen therapy (intrathecal injection of baclofen).

Implantable infusion pumps is considered investigational for all other uses related to pain and spasticity.

Indications for cancer treatment have been removed from this policy; these are considered standard of care.

DESCRIPTION OF PROCEDURE OF SERVICE

Implantable infusion pumps can provide long-term drug infusion at constant or variable rates. Primary uses are delivery of chemotherapy agents and analgesics; several devices are commercially available.

An implantable infusion pump (IIP) is intended to provide long-term continuous or intermittent drug infusion.  Possible routes of administration include intravenous, intra-arterial, subcutaneous, intraperitoneal, intrathecal and epidural.  The IIP is surgically placed in a subcutaneous pocket under the infraclavicular fossa or in the abdominal wall, and a catheter is threaded into the desired position.  Intrathecal and epidural catheter positions are both intraspinal; however, the intrathecal position is located in the subarachnoid space, which is past the epidural space and dura mater and through the theca of the spinal cord.

A drug is infused over an extended period of time and may be delivered at a constant or variable rate by calibrating the IIP per physician specifications.  The drug reservoir may be refilled as needed by an external needle injection through a self-sealing septum in the IIP.  Bacteriostatic water or physiological saline is often used to dilute drugs. A heparinized saline solution may also be used during an interruption of drug therapy to maintain catheter patency.

The driving mechanisms may include peristalsis, fluorocarbon propellant, osmotic pressure, piezoelectric disk benders, or the combination of osmotic pressure with an oscillating piston.

Indications for cancer treatment have been removed from the policy; these are considered standard of care.

KEY POINTS:

The most recent literature update was performed through August 28, 2023.

Summary of Evidence:

Pain

For individuals who have cancer pain who receive intravenous, intrathecal, or epidural injection of opioids with an implantable infusion pump, the evidence includes randomized controlled trials (RCTs) and a systematic review. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. A systematic review included 2 RCTs on implantable infusion pumps for cancer pain; one did not find a difference between groups in pain scores but was likely underpowered. The other RCT found a higher rate of pain reduction with an implantable pump compared with medical management alone; the difference between groups was marginally significant. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have severe, chronic, intractable non-cancer pain who receive intravenous, intrathecal, or epidural injection of opioids with an implantable infusion pump, the evidence includes observational studies and systematic reviews. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. A 2013 systematic review of retrospective and prospective cohort studies indicated reduced pain with intrathecal opioids. A 2009 systematic review included 4 observational studies; 2 showed positive results for pain relief, 1 study had negative results, and results for the fourth were unavailable.

Severe Spasticity

For individuals who have severe spasticity of cerebral or spinal cord origin, unresponsive to or intolerant of oral therapy, who receive intrathecal baclofen with an implantable infusion pump, the evidence includes observational studies, a nonrandomized comparative study, and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Uncontrolled studies and systematic reviews of these studies have reported improvements in spasticity for patients treated using implantable infusion pumps. A nonrandomized comparative study comparing patients with implantable infusion pumps for baclofen delivery to patients on a wait list found significantly greater reductions in spasticity in the group with pump implantation on some outcomes, but not others. RCTs are lacking.

Because of the strong rationale for use, suggestive evidence, and support from clinical guidelines, infusion pumps may be considered medically necessary for cancer pain, chronic, intractable non-cancer pain, and severe spasticity.

Practice Guidelines and Position Statements:

Cancer pain

The v.3.2019 National Comprehensive Cancer Network guidelines for the treatment of adult cancer pain recommend placement of epidural or intrathecal infusion pumps to deliver analgesic or anesthetic drugs.

Non-cancer pain

The 2009 American Society of Interventional Pain Physicians’ evidence-based guidelines on interventions for managing chronic spinal pain indicated that there is strong evidence to support the use of implantable intrathecal drug administration systems with proper patient selection criteria.

Spasticity

National Institute for Health and Care Excellence

In 2016, the National Institute for Health and Care Excellence (NICE) published an evidence-based clinical guideline on the management of spasticity in children and young people with nonprogressive brain disorders. Intrathecal baclofen may be considered for children and young people with spasticity or dystonia that causes difficulty with pain or muscle spasms; posture or function; or self-care or ease of care by parents or caregivers. Additional recommendations include:

• Consideration of potential adverse effects of reducing spasticity when spasticity may support function, e.g., by compensating for muscle weakness.
• A trial of intrathecal baclofen to assess efficacy and adverse events before deciding to implant the intrathecal pump.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Implantable Infusion Pumps, Infusion Pumps, Implantable Pump, Implantable Infusion, intravenous, intrathecal, epidural injection, opioid, Medtronic SynchroMed®, Medtronic IsoMed® infusion system, Flowonix™ Prometra®, Shiley Infusaid®, Baclofen pump

APPROVED BY GOVERNING BODIES:

Several implantable infusion pumps have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process, including, but not limited to, the Medtronic SynchroMed® (Fridley, MN) family of pumps; the Medtronic IsoMed® infusion system (Minneapolis, MN); the Flowonix™ Prometra® programmable pump (Mount Olive, NJ); and Shiley Infusaid® pumps (Norwood, MA).

Baclofen for intrathecal injection was approved for an additional indication in 1996, for use with Medtronic’s implantable infusion pump in the treatment of spasticity of cerebral origin; the drug and pump were originally approved in 1992 for use in patients with severe spasticity of spinal origin. In August 2012, the MedStream™ Programmable Infusion System (Codman and Shurtleff, a division of DePuy), which includes an implantable pump, was approved by FDA through the premarket approval process for intrathecal delivery of baclofen in patients with spasticity.

On November 14, 2018, the FDA issued a safety communication: “Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management.” When considering a medicine for use in an implanted pump the communication recommends, in part, awareness of medicines not FDA approved for intrathecal administration or intrathecal implanted pump use (for example, hydromorphone, bupivacaine, fentanyl, clonidine). Further, the communication indicates that any mixture of two or more different kinds of medications as well as any compounded medications is not approved.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

HCPCS:

REFERENCES:

1. Al Khudhairi DA, Aldin AS, Hamdan Y et al. Continual infusion of intrathecal baclofen (ITB): Long term effect on spasticity. Middle East J Anesthesiol 2010; 20(6):851-5.
2. Ammori JB, Kemeny NE, Fong Y, et al. Conversion to complete resection and/or ablation using hepatic artery infusional chemotherapy in patients with unresectable liver metastases from colorectal cancer: a decade of experience at a single institution. Ann Surg Oncol. Sep 2013; 20 (9):2901-2907.
3. Atli A, Theodore BR, Turk DC et al. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Medicine 2010; 11(7):1010-16.
4. Belinson S, Chopra R, Yang Y, Shankaran V, Aronson N. Local Hepatic Therapies for Metastases to the Liver From Unresectable Colorectal Cancer. Comparative Effectiveness Review No. 93. (Prepared by Blue Cross and Blue Cross Blue Shield Association Technology Evaluation Center under Contract No. 290-2007-10058-I.) AHRQ Publication No.13-EHC014-EF. Rockville, MD: Agency for Healthcare Research and Quality. December 2012. Available online at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.
5. Belinson S, Yang Y, Chopra R, Shankaran V, Samson D, Aronson N. Local Therapies for Unresectable Primary Hepatocellular Carcinoma. Comparative Effectiveness Review No. 114. (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-2007-10058-I.) AHRQ Publication No. 13-EHC069-EF. Rockville, MD: Agency for Healthcare Research and Quality. May 2013. Available online at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.
6. Bonouvrie LA, Becher JG, Vles JS, et al. Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial: the IDYS trial. BMC Pediatr. 2013; 13:175.
7. Borrini L, Bensmail D, Thiebaut JB, et al. Occurrence of adverse events in long-term intrathecal baclofen infusion: a 1-year follow-up study of 158 adults. Arch Phys Med Rehabil. Jun 2014; 95 (6):1032-1038.
8. Callahan MK and Kemeny NE. Implanted hepatic arterial infusion pumps. Cancer J 2010; 16(2):142-9.
9. Dan B, Motta F, Vles JS, et al. Consensus on the appropriate use of intrathecal baclofen (ITB) therapy in paediatric spasticity. Eur J Paediatr Neurol 2010; 14(1):19-28.
10. Duarte RV, Raphael JH, Sparkes E et al. Long-term intrathecal drug administration for chronic nonmalignant pain. J Neurosurg Anesthesiol 2012; 24(1):63-70.
11. Falco FJ, Patel VB, Hayek SM et al. Intrathecal infusion systems for long-term management of chronic non-cancer pain: an update of assessment of evidence. Pain Physician 2013; 16(2 Suppl):SE185-216.
12. FDA. Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication (November 14, 2018). https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm625789.htm.
13. Ghosh D, Mainali G, Khera J, et al. Complications of intrathecal baclofen pumps in children: experience from a tertiary care center. Pediatr Neurosurg. 2013; 49:138-144.
14. Hamza M, Doleys D, Wells M et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med 2012; 13(10):1304-13.
15. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
16. Jaaback K, Johnson N, Lawrie TA. Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer. Cochrane Database Syst Rev 2011; (11):CD005340.
17. Lara NA, Teixeira MJ, Fonoff ET. Long term intrathecal infusion of opiates for treatment of failed back surgery syndrome. Acta Neurochir Suppl 2011; 108:41-7.
18. Liu C, Cui Q, Guo J, et al. Intra-Arterial Intervention Chemotherapy for Sarcoma and Cancerous Ulcer via an Implanted Pump. Pathol Oncol Res. Jan 21 2014.
19. Mahawar, B., Kannan, A., Mahawar, V., & Srinivasan, S. (2023). Intrathecal pain pumps in pain relief. Clinical radiology, 78(4), 240–244.
20. Malheiro L, Gomes A, Barbosa P, et al. Infectious complications of intrathecal drug administration systems for spasticity and chronic pain: 145 patients from a tertiary care center. Neuromodulation. Jul 2015; 18(5):421-427.
21. Margetis K, Korfias S, Boutos N, et al. Intrathecal baclofen therapy for the symptomatic treatment of hereditary spastic paraplegia. Clin Neurol Neurosurg. Aug 2014; 123:142-145.
22. Matharu G, Tucker O, Alderson D. Systematic review of intraperitoneal chemotherapy for gastric cancer. Br J Surg 2011; 98(9):1225-35.
23. Mathur SN, Chu SK, McCormick Z, et al. Long-term intrathecal baclofen: outcomes after more than 10 years of treatment. PM R. Jun 2014; 6(6):506-513 e501.
24. McIntyre A, Mays R, Mehta S, et al. Examining the effectiveness of intrathecal baclofen on spasticity in individuals with chronic spinal cord injury: a systematic review. J Spinal Cord Med. Jan 2014; 37(1):11-18.
25. Morton RE, Gray N, Vloeberghs M. Controlled study of the effects of continuous intrathecal baclofen infusion in non-ambulant children with cerebral palsy. Dev Med Child Neurol 2011; 53(8):736-41.
26. Motta F, Antonello CE, Stignani C et al. Intrathecal baclofen and motor function in cerebral palsy. Dev Med Child Neurol 2011; 53(5):443-8.
27. Motta F, Antonello CE. Analysis of complications in 430 consecutive pediatric patients treated with intrathecal baclofen therapy: 14-year experience. J Neurosurg Pediatr. Mar 2014; 13 (3):301-306.
28. Myers J, Chan V, Jarvis V, et al. Intraspinal techniques for pain management in cancer patients: a systematic review. Support Care Cancer 2010; 18(2):137-49.
29. National Cancer Institute (NCI). Adult Primary Liver Cancer Treatment (PDQ®). Available online at: www.cancer.gov/cancertopics/pdq/treatment/adult-primary-liver/HealthProfessional.
30. National Cancer Institute (NCI). Colon Cancer Treatment (PDQ®). Available online at: www.cancer.gov/cancertopics/pdq/treatment/colon/HealthProfessional.
31. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: adult cancer pain, version 1.2018. www.nccn.org/professionals/physician_gls/pdf/pain.pdf.
32. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: basal cell and squamous cell skin cancers, version 2.2014. www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf
33. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: bone cancer, version 1.2015. www.nccn.org/professionals/physician_gls/pdf/bone.pdf.
34. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: melanoma, version 1.2015. www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf.
35. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: head and neck cancers, version 2.2014. www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf.
36. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: ovarian cancer including fallopian tube cancer and primary peritoneal cancer, version 3.2014. www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf.
37. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: soft tissue sarcoma, version 2.2014. www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf.
38. National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: adult cancer pain. Version 1.2019. http://www.nccn.org/professionals/physician_gls/pdf/pain.pdf.
39. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: Colon Cancer. v. 2.2015. Available online at: www.nccn.org/professionals/physician_gls/PDF/colon.pdf.
40. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: Hepatobiliary Cancer. v. 2.2014. Available online at: www.nccn.org/professionals/physician_gls/PDF/hepatobilliary.pdf.
41. National Institute for Health and Care Excellence (NICE). Spasticity in children and young people with non-progressive brain disorders: management of spasticity and co-existing motor disorders and their early musculoskeletal complications, July 2012. Available online at: www.guidance.nice.org.uk/CG145.
42. Pin TW, McCartney L, Lewis J et al. Use of intrathecal baclofen therapy in ambulant children and adolescents with spasticity and dystonia of cerebral origin: a systematic review. Dev Med Child Neurol 2011; 53(10):885-95.
43. Ponche ST, Ferrapie AL, Chenet A et al. Intrathecal baclofen in cerebral palsy: a retrospective study of 25 wheelchair-assisted adults. Ann Phys Rehab Med 2010; 53(8):483-98.
44. Rekand T. Clinical assessment and management of spasticity: a review. Acta Neurol Scand Suppl 2010; 190:62-6.
45. Saval A, Chiodo AE. Intrathecal baclofen for spasticity management: a comparative analysis of spasticity of spinal vs cortical origin. J Spinal Cord Med 2010; 33(1):16-21.
46. Spaan N, Teplova A, Stam G, et al. Systematic review: continuous intraperitoneal insulin infusion with implantable insulin pumps for diabetes mellitus. Acta Diabetol. Jun 2014; 51(3):339-351.
47. Stokic DS, Yablon SA. Effect of concentration and mode of intrathecal baclofen administration on soleus H-reflex in patients with muscle hypertonia. Clin Neurophysiol 2012; 123(11):2200-4.
48. Ucar T, Kazan S, Turgut U et al. Outcomes of intrathecal baclofen (ITB) therapy in spasticity. Turk Neurosurg 2011; 21(1):59-65.
49. van Dijk PR, Logtenberg SJ, Groenier KH, et al. Continuous intraperitoneal insulin infusion in type 1 diabetes: a 6-year post-trial follow-up. BMC Endocr Disord. 2014; 14:30.
50. van Dijk PR, Logtenberg SJ, Groenier KH, et al. Report of a 7 year case-control study of continuous intraperitoneal insulin infusion and subcutaneous insulin therapy among patients with poorly controlled type 1 diabetes mellitus: Favourable effects on hypoglycemic episodes. Diabetes Res Clin Pract. Sep 30 2014.
51. Veizi IE, Hayek SM, Narouze S et al. Combination of intrathecal opioids with bupivacaine attenuates opioid dose escalation in chronic noncancer pain patients. Pain Med 2011; 12(10):1481-9.
52. Vles GF, Soudant DL, Hoving MA, et al. Long-term follow-up on continuous intrathecal Baclofen therapy in non-ambulant children with intractable spastic Cerebral Palsy. Eur J Paediatr Neurol. Nov 2013; 17 (6):639-644.

POLICY HISTORY:

Medical Policy Group, July 2010 (3)

Medical Policy Administration Committee, August 2010

Available for comment August 6-September 18, 2010

Medical Policy Group, October 2011; Updated Policy (clarification only), Key Points, & References

Medical Policy Group, November 2011 (1); Added 2012 CPT Codes effective 1/1/2012

Medical Policy Group, December 2012 (3): 2013 Coding Update: Verbiage change to code 62370

Medical Policy Panel November, 2012

Medical Policy Group, July 2013 (1): Primary epithelial ovarian cancer (intraperitoneal infusion as component of chemotherapy) added as medically necessary; clarification statement added to severe intractable pain bullet “excludes headache or head pain, refer to policy #314”; coverage for head/neck cancers (intra-arterial injection of chemotherapeutic agents) remains unchanged, as do all remaining coverage statements; Update to Key Points and References.

Medical Policy Administration Committee, August 2013

Available for comment July 23 through October 1, 2013

Medical Policy Panel, November 2013

Medical Policy Group, January 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (4): Updates to Key Points and References.  Updated policy statement to “including, but not limited to bone or soft tissue sarcomas, skin cancers”.

Medical Policy Panel, February 2017

Medical Policy Group, February 2017 (6): Updates to Policy statement, removed cancer indications as these are now standard of care, Clarified policy title, now reads Implantable Infusion Pump for Pain and Spasticity, Key Points, Coding and References.

Medical Policy Panel, February 2018

Medical Policy Group, February 2018 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Panel, February 2019

Medical Policy Group, February 2019 (6): Updates to Key Points and References.

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (6): Updates to Key Points and Practice Guidelines.

Medical Policy Group, March 2020 (6): Effective March 17, 2020 : Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, August 2021 (6): Updates to Key Points, Governing Bodies, Coding and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, August 2022 (6): Updates to Key Points.

Medical Policy Group, August 2023 (6): Updates to Key Points, Benefit Application, and References. No change to Policy Statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.