BlueCross and BlueShield of Montana Medical Policy/Codes
Implantable Infusion Pump
Chapter: Surgery: Procedures
Current Effective Date: September 24, 2013
Original Effective Date: June 24, 2013
Publish Date: September 24, 2013
Description

An implantable infusion pump 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 implantable infusion pump 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 implantable infusion pump per physician specifications. The drug reservoir may be refilled as needed by an external needle injection through a self-sealing septum in the implantable infusion pump. 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.

Regulatory Status

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 SynchroMed (Fridley, MN) family of pumps, Codman® 3000 (Raynham, MA), Arrow International Constant Flow, and Shiley Infusaid pumps (Norwood, MA).

Policy

Prior authorization is recommended. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review is performed if services are not prior authorized.

Medically Necessary

BCBSMT may consider implantable infusion pumps medically necessary when used to deliver drugs that are FDA approved for both the condition and the route of administration, for the treatment of:

  1. Primary liver cancer (intrahepatic artery injection of chemotherapeutic agents); or
  2. Metastatic colorectal cancer where metastases are limited to the liver (intrahepatic artery injection of chemotherapeutic agents); or
  3. Head and/or neck cancers (intra-arterial injection of chemotherapeutic agents); or
  4. Intractable pain or spasticity.

Implantable infusion pumps may be considered medically necessary when used for the intrathecal administration of drugs for treatment of:

  1. Severe spasticity of cerebral or spinal cord origin in patients who are unresponsive to or who cannot tolerate oral baclofen therapy (*see Note 1 below); or
  2. Severe, chronic, intractable pain in patients who have a life expectancy of at least three months, and who are intolerant of or unresponsive to less invasive medical therapy, including but not limited to pharmacologic, surgical, psychological, or physical treatment modalities (*see Note 1 below); this includes administration of:
    • single drugs that are FDA approved, OR
    • compounded drugs whose ingredients are FDA approved (**see Note 2 below)

*NOTE:  For treatment of severe spasticity or severe, chronic intractable pain, the patient should have responded favorably to a trial period using an external pump prior to permanent implantation.

Investigational

BCBSMT considers implantable infusion pumps are considered experimental, investigational and unproven for all other uses including, but not limited to, heparin for thromboembolic disease, insulin for diabetes, and/or antibiotics for osteomyelitis.

NOTE:  Replacement, revision or removal of catheter, reservoir, and/or pump will not require additional medical necessity review.

Federal Mandate

Federal mandate prohibits denial of any drug, device or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana
recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.
 
Rationale
 
Cancer Pain

A systematic review of the literature, published in 2010 by Myers and colleagues (1), identified 12 randomized controlled trials (RCTs) on intraspinal techniques for managing pain in cancer patients; studies are required to report pain as an outcome measure using a validated scale. The investigators did not identify the type or types of cancer addressed in individual studies and did not pool study findings. Two RCTs specifically addressed implantable infusion pumps. One compared intrathecal morphine delivered via an implantable infusion pump plus medical management (n=101) to medical management alone (n=99) in patients with refractory cancer pain. The difference between groups in clinical success (defined as at least 20% reduction in pain score and at least 20% reduction in drug toxicity at 4 weeks) reached borderline statistical significance, favoring the implantable pump group over the control group (85% vs. 71%, respectively, p=0.05). The proportion of patients who experienced pain score reduction was 52% in the implantable pain pump group and 39% in the control group; this was not a statistically significant difference (p=0.55). The other RCT on implantable pumps compared epidural morphine delivered as a continuous infusion by the Infusaid pump to intermittent delivery by a Port-a-Cath® (Deltec, Saint Paul, MN). The 2 groups did not differ significantly in their pain scores; scores were low in both groups and the study, which had only 29 participants, was likely underpowered. The authors of the systematic review concluded that intraspinal techniques may be appropriate for selected cancer patients with intractable cancer pain but note the shortage of RCTs.

Noncancer Pain

A systematic review by Patel and colleagues on intrathecal infusion pumps used to treat chronic non-cancer pain was published in 2009. (2) To be included in the review, studies needed to evaluate an intrathecal device (programmable or fixed infusion rate), state a specific indication and the drug that was injected, follow patients for at least 12 months, and include at least 25 patients. In addition, the investigators rated study quality and, to be included, studies needed to score at least 50 out of 100 on a methodologic quality scale. The primary outcome of interest to the systematic review was pain relief. A total of 15 studies on intrathecal infusion for non-cancer pain were identified; however, 6 did not have sufficient follow-up, 4 included fewer than 25 patients, and 1 had unacceptably low quality, leaving 4 eligible studies. All of the studies were observational and involved intrathecal opioid administration; sample sizes ranged from 69 to 120. Most patients experienced lumbospinal pain. Two of the 4 studies showed positive results for pain relief, one study had negative results, and results were not available for the fourth study. The authors of the systematic review acknowledged the paucity of literature and lack of RCTs. Using the grading system developed by Guyatt and colleagues, the authors concluded that a 1C recommendation is appropriate; that is, a strong recommendation based on low-quality or very low-quality evidence in which the benefits outweigh the risks and the recommendation may change when higher quality evidence becomes available. (3)

Several additional case series with at least 25 patients were identified in the 2011 literature search. One study conducted in the United States was published in 2010 by Atli and colleagues. (4) This was a retrospective review of outcomes in 57 patients referred for pain management at a single center who received an implanted intrathecal infusion pump. Twenty-eight of the 57 (49%) patients had failed back surgery syndrome, 16 (28%) had neuropathic pain, and the remaining 13 (23%) had a variety of different diagnoses. A preservative-free opioid (usually morphine) was infused, and the patients could also receive oral medication; adjustments in dosage could be made at any time. Forty-nine of 57 patients (86%) completed the 3-year follow-up. At the time of the first pump refill (3-6 months), 23 of 49 (47%) study completers reported having at least a 50% reduction in pain from baseline, as measured on a 10-point visual analogue scale. The proportion of responders decreased over time and, at the 3-year follow-up, 9 of 49 (18%) had at least a 50% reduction in pain from baseline. The 9 patients represented 39% of those who met the at least 50% criterion at the first refill. The use of oral opioids was significantly lower at the 1- and 3-year follow-ups than at baseline (p-values not reported). The mean baseline oral opioid dose in morphine or its equivalent was 184 mg/24 hours. At 1- and 3-years, mean doses were 44 mg/24 hours and 58 mg/24 hours, respectively. At 3 years, 12 of 49 (25%) patients had ceased all oral opioid use. In contrast, the mean dose of intrathecal opioids significantly increased during follow-up, compared to the dose at discharge after pump implantation. The mean dose at discharge was 6.5 mg/24 hours, at 1 year was 9.3 mg/24 hours, and at 3 years was 12.2 mg/24 hours. Complications occurred in 10 of 57 (17.5%) patients; these included 5 infections, 3 catheter revisions, 2 seromas at the pump site, and 2 intrathecal granulomas. A second case series, conducted in Brazil, included 78 patients with failed back surgery syndrome, 30 (38%) of whom underwent implantation of an infusion pump. (5) Outcomes were not reported separately for patients who did and did not receive the implanted pump.

Chemotherapy for Cancer Patients

In 2009, a Cochrane review was published comparing hepatic arterial infusion versus systemic chemotherapy for patients with unresectable liver metastases from colorectal cancer. (6) Ten trials that evaluated a total of 1,277 patients were included. Nine of these provided data on tumor response. The response rate was significantly higher in the hepatic arterial infusion group (198 of 461, 43%) than the systemic chemotherapy group (81 of 440, 18%). The pooled risk ratio was 2.26 (95% confidence interval [CI]: 1.80-2.84). However, there was not a significantly higher survival rate associated with hepatic arterial infusion chemotherapy. The mean weighted median overall survival times were 15.9 months with hepatic arterial infusion chemotherapy and 12.4 months for systemic chemotherapy (pooled hazard ratio: 0.90; 95% CI: 0.76-1.07). Adverse effects and quality-of-life outcomes were not reported.

A recent review article discussed use of hepatic arterial infusion chemotherapy in patients with conditions other than colorectal cancer. (7) They note that the most evidence is available for patients with primary liver tumors. For example, one study with 34 patients with unresectable primary liver cancers found a partial response in 16 (47%). Moreover, the authors report that only small studies have been published for other conditions, such as treatment of liver metastases from breast cancer, gastric cancer, and melanoma.

Severe spasticity

No systematic reviews, meta-analyses or RCTs were identified that evaluated implanted infusion pumps for severe spasticity of cerebral or spinal cord origin. Several case series reporting on intrathecal baclofen therapy for spasticity were published in 2010 and 2011; sample sizes ranged from 25 to 57. (8-12) All but one study (8) was retrospective. The 4 studies that reported on clinical efficacy (i.e., pain or function) found generally improved outcomes after pump implantation compared to preimplantation; however, studies lacked comparison groups. For example, Motta and colleagues in Italy found a statistically significant increase in the Gross Motor Function Measure (GMFM) score after 1 year. (9) The median GMFM score (as a percentage of maximum score) in 30 cerebral palsy patients with spasticity who received intrathecal baclofen increased from 65.0 to 69.4, p=0004. Only one study was published in the United States, (10) but this did not report efficacy outcomes. Most of the studies had limited reporting of methods and outcomes.

A 2010 review article on treatment of spasticity states that intrathecal baclofen may be effective for treating spasticity of spinal and cerebral origin when oral treatment is ineffective. (13) The author notes that technical complications, such as catheter migration, leakage or fibrosis, have been reported to occur frequently.

Other Indications

No systematic reviews, meta-analyses, or large RCTs were identified on use of implanted infusion pumps for any additional indication.

Ongoing Clinical Trials

Spasticity in stroke study (14): This randomized controlled trial is comparing intrathecal baclofen therapy to best medical treatment for patients with severe spasticity at least 6 months following stroke. The primary outcome is change in the Ashworth scale. As of June 2012 the study is currently recruiting patients.

Practice Guidelines and Position Statements

In 2010, the European Working group for Spasticity in Children published a consensus statement on use of intrathecal baclofen therapy in children with spasticity. (15) For children with spasticity that interferes with function or quality of life, they recommend that conservative treatment and a trial of oral medication be tried prior to use of a pump to deliver intrathecal baclofen. They also recommend individuation of treatment and involvement of parents and caregivers. The group received an unrestricted educational grant from Medtronic (Minneapolis, MN).

The 2011 guidelines from the National Comprehensive Cancer Network include the following statements:

  • “Placement of a hepatic arterial port or implantable pump during surgical intervention for liver resection with subsequent infusion of chemotherapy directed to the liver metastases through the hepatic artery (e.g., HAI) remains an option.” (16)
  • “The panel recommends that systemic single agent or combination chemotherapy, intra-arterial chemotherapy, as well as the combination of chemotherapy and radiation therapy be given to patients with unresectable HCC only in the context of a clinical trial.” (17)

In 2003, the American Society of Interventional Pain Physicians published evidence-based guidelines on interventions for managing chronic spinal pain. (18) The guidelines state that there is moderate evidence from randomized and non-randomized trials supporting the long-term effectiveness of intrathecal infusion systems for patients with chronic back pain.

American Diabetes Association Standards of Medical Care in Diabetes- 2010 and the American Pain Society treatment guidelines on opioid therapy for non-cancer pain do not mention implantable infusion pumps. (19,20)

Summary

Current literature searches have not identified any studies that would lead to major changes in the policy statements. Conclusions from systematic reviews are that, although limited, the available evidence suggests that implantable infusion pumps may improve the net health outcome in cancer and non-cancer patients with intractable pain. Moreover, a meta-analysis (6) of randomized controlled trials found that hepatic arterial infusion of chemotherapy with implanted infusion pumps improves tumor control for patients with metastases limited to the liver. Published evidence on implantable infusion pumps for treatment of spasticity is limited. No high-quality studies were identified providing evidence in support of possible additional uses of implantable infusion pumps.

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

03.90, 38.91, 86.06, 154.0, 155.0, 155.2, 195.7, 336.1, 340, 342.10-342.12, 343.0, 343.1, 343.3, 343.4, 344.1, 344.2, 344.30-344.32, 344.40-344.42, 344.81-344.89, 722.83, 996.40-996.49

ICD-10 Codes

C00-C14.8 ,  C19, C22.0; C22.2-C22.9, C76.0, C78.7, G95.11 – G95.19, G35, G56.40-G56.42, G57.70-G57.72, G80.0-G80.9, G81.10-G81.14, G82.20-G82.22, G83.0-G83.9, G89.21-G89.28, G89.3, G89.4, G90.50-G90.59, M96.1, 0FH003Z, 0FH033Z, 0FH043Z, 0FH103Z, 0FH133Z, 0FH143Z, 0FH203Z, 0FH233Z, 0JH60VZ, 0JH63VZ, 0JH70VZ, 0JH73VZ, 0JH80VZ, 0JH83VZ, 0JHD0VZ, 0JHD3VZ, 0JHF0VZ, 0JHF3VZ, 0JHG0VZ, 0JHG3VZ, 0JHH0VZ, 0JHH3VZ, 0JHL0VZ, 0JHL3VZ, 0JHM0VZ, 0JHM3VZ, 0JHN0VZ, 0JHN3VZ, 0JHP0VZ, 0JHP3VZ, 0JHS03Z, 0JHS33Z, 0JHT33Z, 0JHT3VZ, 0JHV03Z, 0JHV33Z, 0JHW03Z, 0JHW33Z, 0RH003Z, 0RH033Z, 0RH043Z, 0RH103Z, 0RH133Z, 0RH143Z, 0RH303Z, 0RH333Z, 0RH343Z, 0RH403Z, 0RH433Z, 0RH443Z, 0RH503Z, 0RH533Z, 0RH543Z, 0RH603Z, 0RH633Z, 0RH643Z, 0RH903Z, 0RH933Z, 0RH943Z, 0RHA03Z, 0RHA33Z, 0RHA43Z, 0RHB03Z, 0RHB33Z, 0RHB43Z, 0RHE03Z, 0RHE33Z, 0RHE43Z, 0RHF03Z, 0RHF33Z, 0RHF43Z, 0RHG03Z, 0RHG33Z, 0RHG43Z, 0RHH03Z, 0RHH33Z, 0RHH43Z, 0RHJ03Z, 0RHJ33Z, 0RHJ43Z, 0RHK03Z, 0RHK33Z, 0RHK43Z, 0RHL03Z, 0RHL33Z, 0RHL43Z, 0RHM03Z, 0RHM33Z, 0RHM43Z, 0RHN03Z, 0RHN33Z, 0RHN43Z, 0RHP03Z, 0RHP33Z, 0RHP43Z, 0RHQ03Z, 0RHQ33Z, 0RHQ43Z, 0RHR03Z, 0RHR33Z, 0RHR43Z, 0RHS03Z, 0RHS33Z, 0RHS43Z, 0RHT03Z, 0RHT33Z, 0RHT43Z, 0RHU03Z, 0RHU33Z, 0RHU43Z, 0RHV03Z, 0RHV33Z, 0RHV43Z, 0RHW03Z, 0RHW33Z, 0RHW43Z, 0RHX03Z, 0RHX33Z, 0RHX43Z, 0SH003Z, 0SH033Z, 0SH043Z, 0SH203Z, 0SH233Z, 0SH243Z, 0SH303Z, 0SH333Z, 0SH343Z, 0SH403Z, 0SH433Z, 0SH443Z, 0SH503Z, 0SH533Z, 0SH543Z, 0SH603Z, 0SH633Z, 0SH643Z, 0SH703Z, 0SH733Z, 0SH743Z, 0SH803Z, 0SH833Z, 0SH843Z, 0SH903Z, 0SH933Z, 0SH943Z, 0SHB03Z, 0SHB33Z, 0SHB43Z, 0SHC03Z, 0SHC33Z, 0SHC43Z, 0SHD03Z, 0SHD33Z, 0SHD43Z, 0SHF03Z, 0SHF33Z, 0SHF43Z, 0SHG03Z, 0SHG33Z, 0SHG43Z, 0SHH03Z, 0SHH33Z, 0SHH43Z, 0SHJ03Z, 0SHJ33Z, 0SHJ43Z, 0SHK03Z, 0SHK33Z, 0SHK43Z, 0SHL03Z, 0SHL33Z, 0SHL43Z, 0SHM03Z, 0SHM33Z, 0SHM43Z, 0SHN03Z, 0SHN33Z, 0SHN43Z, 0SHP03Z, 0SHP33Z, 0SHP43Z, 0SHQ03Z, 0SHQ33Z, 0SHQ43Z

Procedural Codes: 36260, 36261, 36362, 36563, 36576, 36583, 36590, 61215, 62350, 62351, 62360, 62361, 62362, 62365, 62367, 62368, A4220, A4300, A4301, E0782, E0783, E0785, E0786
References
  1. 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.
  2. Patel VB, Manchikanti L, Singh V et al. Systematic review of intrathecal infusion systems for long-term management of chronic non-cancer pain. Pain Physician 2009; 12(2):345-60.
  3. Guyatt G, Gutterman D, Baumann MH et al. Grading strength of recommendations and quality of evidence in clinical guidelines. Chest 2006; 129(1):174-91.
  4. 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.
  5. 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.
  6. Mocellin S, Pasquali S, Nitti D. Fluoropyrimidine-HAI (hepatic arterial infusion) versus systemic chemotherapy (SCT) for unresectable liver metastases from colorectal cancer. Cochrane Database Syst Rev 2009; (3):CD007823.
  7. Callahan MK, Kemeny NE. Implanted hepatic arterial infusion pumps. Cancer J 2010; 16(2):142-9.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Ucar T, Kazan S, Turgut U et al. Outcomes of intrathecal baclofen (ITB) therapy in spasticity. Turk Neurosurg 2011; 21(1):59-65.
  13. Rekand T, Clinical assessment and management of spasticity: a review. Acta Neurol Scand Suppl 2010; 190:62-6.
  14. SISTERS: Spasticity in Stroke Study (NCT01032239). Sponsored by Medtronic International Trading Sarl. Last updated December 13, 2010. Available online at: www.clinicaltrials.gov . Last accessed June 2012.
  15. 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.
  16. National Comprehensive Cancer Network. Colon Cancer. Clinical practice guidelines in oncology, v.3.2011. Available online at: www.nccn.org . Last accessed June 2012.
  17. National Comprehensive Cancer Network. Hepatobilliary Cancer. Clinical practice guidelines in oncology, v1.2011. Available online at: <www.nccn.org>. Last accessed June 2012.
  18. Manchikanti L, Staats PS, Singh V et al. Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain. Pain Phys 2003; 6(1):3-81. Available online at: www.asipp.org . Last accessed June 2012.
  19. American Diabetes Association. Standards of medical care in diabetes- 2010. Diabetes Care 2010; 33(suppl 1):S11-61.
  20. Chou R, Fanciullo GJ, Fine PG et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009; 10(2):113-30.
  21. Implantable Infusion Pump. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (August 2011) Surgery 7.01.41.
History
June 2013  New 2013 BCBSMT medical policy.
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Implantable Infusion Pump