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MP 7.01.41 Implantable Infusion Pump

Medical Policy    
Section
Surgery
 
Original Policy Date
11/30/96
Last Review Status/Date
Reviewed with literature search/8:2012
Issue
8:2012
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

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 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). In August 2012, the FDA approved the MEDSTREAM Programmable Infusion System (Codman and Shurtleff), which includes an implantable pump, for intrathecal delivery of baclofen in patients with spasticity.


Policy

Implantable infusion pumps are 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:

  • Cancer in the following situations:
    • Primary liver cancer (intrahepatic artery injection of chemotherapeutic agents);
    • Metastatic colorectal cancer where metastases are limited to the liver (intrahepatic artery injection of chemotherapeutic agents);
    • Primary epithelial ovarian cancer (intraperitoneal infusion as component of chemotherapy)
  • 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; and
  • 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 are considered investigational for all other uses (e.g., chemotherapy for patients with head and neck cancers or gastric cancer, heparin for thromboembolic disease, insulin for diabetes, antibiotics for osteomyelitis).


Policy Guidelines

No applicable information


Benefit Application
BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all U.S. Food and Drug Administration (FDA)-approved devices may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.

Baclofen for intrathecal injection was approved for an additional indication on June 14, 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.


Rationale
This original policy was based on a search of the MEDLINE database through December 1995. The policy was on “no further review” status from 2003 until 2010, at which time it returned to active status. Since 2010, literature searches have been performed regularly, most recently for the period June 2011 through September 2012. Following is a summary of the key literature published to date:

Chemotherapy for Cancer Patients

Primary liver cancer

No randomized controlled trials (RCTs) have evaluated whether hepatic arterial infusion of chemotherapy in patients with primary liver cancer improves health outcomes. Several case series were identified. Most recently, Jarnagin and colleagues reported on 34 patients with unresectable primary liver cancer who received hepatic arterial infusion of floxuridine and dexamethasone. (1) Sixteen of 34 (47%) patients had a partial response to treatment. Median survival was 29.5 months; the 2-year survival rate was 67%. In addition, Smith and colleagues studied 11 patients and found a complete response to chemotherapy in 1 patient and partial responses in 6 patients. (2) Atiq and colleagues found a partial response in 4 of 10 (40%) of patients with unresectable liver cancer treated with intrahepatic chemotherapy delivered through an implantable pump. (3) The evidence is limited but suggests that some patients, with limited other treatment options, may benefit from arterial infusion of chemotherapy.

Liver metastases from colorectal cancer

In 2009, a Cochrane review was published comparing hepatic arterial infusion versus systemic chemotherapy for patients with unresectable liver metastases from colorectal cancer. (4) Ten RCTs 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 (RR) 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.

This evidence suggests that arterial infusion of chemotherapy improves response rates for patients with colorectal cancer metastatic to the liver compared to systemic chemotherapy. The impact on survival is uncertain.

Head and neck cancers

Several studies have evaluated interventions that combine radiotherapy and concomitant intra-arterial cisplatin (known as RADPLAT) on patients with head and neck cancer. These studies used intra-arterial delivery of cisplatin via an intra-arterial catheter rather than an implantable pump. Although an implantable infusion pump was not used, the principle of treatment is similar, so that these studies have some relevance to the evaluation of infusion pumps.

In 2006, Hoebers and colleagues in The Netherlands randomized patients with stage III or IV head and neck squamous cell carcinoma to radiotherapy with standard intravenous (IV) cisplatin (n=21) or high-dose intra-arterial cisplatin (n=14). (5) Rates of acute mucositis and hematological toxicity did not differ significantly between groups; however, there was a higher rate of acute renal toxicity in the IV group (30%) compared to the intra-arterial group (0%). Over 2 years, there were no significant differences between treatment groups in locoregional control of disease, disease-free survival, or overall survival.

A study by Ackerstaff and colleagues examined 17 quality-of-life scales at several time points after treatment with radiotherapy with intravenous or intra-arterial cisplatin. (6) The study included 207 patients with inoperable advanced head and neck cancer. The only statistically significant difference between groups was in the nausea/vomiting scale at 7 weeks, at which time the rate of symptoms were higher in the intravenous compared to the intra-arterial group. Otherwise, quality-of-life symptoms were similar in the 2 groups.

Evidence from 2 RCTs did not find a clear advantage of intra-arterial chemotherapy delivered via an intra-arterial catheter compared to IV chemotherapy in combination with radiotherapy for patients with head and neck cancer. Therefore, it is not likely that similar agents delivered via an implantable infusion pump would improve outcomes.

Primary epithelial ovarian cancer

A 2011 Cochrane review examined literature on whether an intraperitoneal (IP) component of chemotherapy improves ovarian cancer outcomes compared to intravenous chemotherapy-only. (7) Nine RCTs with a total of 2,119 patients were identified; 6 trials were considered to be of high-quality. In a pooled analysis of data from 8 studies, there was a significantly lower rate of mortality with an IP component of chemotherapy compared to no IP component (hazard ratio [HR]: 0.81; 95% CI: 0.72 to 0.90). Moreover, a pooled analysis of data from 5 studies found that an IP component of chemotherapy is associated with a significantly longer disease-free interval (HR: 0.78: 95% CI: 0.70 to 0.86). However, an IP component of chemotherapy was associated with significantly more adverse effects (e.g., infection, fever, pain, and gastrointestinal symptoms). For example, a pooled analysis of 3 studies found a significantly higher infection rate when there was an IP component of chemotherapy compared to IV-only chemotherapy (RR: 3.34, 95% CI: 2.06 to 5.43).

An example of one of the individual RCTs is a high-quality RCT with a relatively large number of patients published by Markman and colleagues in 2001. (8) This was a multicenter study conducted in the United States and included women diagnosed with stage III epithelial ovarian cancer who entered the study within 6 weeks of surgery. Patients were randomized to receive either standard dose IV cisplatin/paclitaxel for 6 courses or 2 cycles of moderately high-dose carboplatin, followed by 6 courses of IV paclitaxel and intraperitoneal cisplatin. A total of 523 patients entered the trial, and 61 (12%) were subsequently found to be ineligible for reasons including the wrong stage of cancer or inadequate surgery. Of the remaining 462 eligible patients, 227 were in the IV chemotherapy-only group and 235 were in the intraperitoneal component chemotherapy group. At the time of data analysis, 103 of 227 (45.4%) patients in the IV-only group and 126 of 235 (53.6%) in the IP-component chemotherapy group were still alive. There was an improvement in survival with IP chemotherapy that was of borderline statistical significance (RR: 0.81; 95% CI: 0.65 to 1.00). The length of progression-free survival was significantly longer in the IP chemotherapy component group compared to the IV chemotherapy-only group (median time to recurrence: 27.9 months vs. 22.2 months, respectively, p=0.01). Rates of several adverse events were higher in the IP chemotherapy component group compared to the IV-only chemotherapy group. These included grade 3-4 gastrointestinal events (37% vs. 17%, respectively) and platelet toxicity (3% vs. 49%, respectively). Two patients in each group died of causes considered to be related to chemotherapy.

The evidence from multiple RCTs, including some of high-quality, and systematic reviews, indicates that intraperitoneal chemotherapy for patients with primary epithelial ovarian cancer has a significant impact on progression-free survival and likely also improves overall survival. This benefit is accompanied by an increased risk of adverse effects with intraperitoneal infusions, including infections, pain, and gastrointestinal symptoms.

Gastric cancer

A 2011 systematic review examined RCTs and observational studies on intraperitoneal chemotherapy used to treat gastric cancer. (9) The authors identified 14 studies, 2 RCTs, 2 case-control studies and 10 observational studies. One of the RCTs compared groups of patients who did and did not receive intraperitoneal taurolidine following tumor resection and did not find statistically significant differences in outcomes. The other RCT (n=118) found a significantly higher rate of survival in patients who received either IP chemotherapy plus intraoperative peritoneal lavage or IP chemotherapy-only in addition to surgery versus surgery only. (Additionally, all patients in the second study received adjuvant oral 5-fluorouracil derivatives for 2 years.) The authors of the systematic review recommended that future studies evaluate preoperative or intraoperative IP chemotherapy in association with systemic chemotherapy. There is insufficient evidence on intraperitoneal chemotherapy for treating gastric cancer, and therefore, no change was made to the policy statement.

Pain

Cancer pain

One systematic review of the literature was identified; it was published in 2010 by Myers and colleagues. (10) They identified 12 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. (11) 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. (12)

Several additional case series were identified in recent literature searches. One study conducted in the United States was published in 2010 by Atli and colleagues. (13) 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. Another retrospective case series conducted in the United States and published in 2011 included 126 non-cancer intractable pain patients. (14) Patients received intrathecal opioids-only (n=72) or opioids and bupivacaine (n=54). Outcomes were evaluated 12 months after pump implantation. Pain intensity was assessed using an 11-point numeric rating scale (NRS) where 0=no pain and 10=the worst imaginable pain. In the group that began with opioids-only, mean pain intensity score decreased significantly from 7.42 (standard deviation [SD]: 2.1) at baseline to 5.85 (SD: 2.8) at 12 months, p<0.001. In the opioid plus bupivacaine group, the mean pain intensity score decreased from 7.35 (SD: 2.1) at baseline to 5.03 (SD: 2.4) at 12 months, p<0.001.

In 2012, Duarte and colleagues in the U.K. published a case series with long-term follow-up on 20 patients with chronic nonmalignant pain who received intrathecal delivery of opioid analgesics. (15) Patients were followed for a mean of 13.5 years (range: 10.4 to 17.9 years). At 4-year and 13-year assessments, outcomes were significantly improved compared to baseline. However, outcomes did not significantly improve between 4 and 13 years. For example, mean pain intensity (measured on an 11-point scale where 0 represents no pain and 10 represents the worst pain) was 8.65 (SD: 0.29) at baseline, 4.95 (SD: 0.53) at 4 years post-treatment, and 5.30 (SD: 0.35) at 13 years post-treatment. Similarly, the mean quality-of-life score (0 represents no interference with quality of life and 10 represents maximum interference) was 8.45 (SD: 0.49) at baseline, 4.95 (SD: 0.69) at 4 years, and 4.45 (SD: 0.48) at 13 years.

The evidence on the use of infusion pumps for chronic, non-cancer pain consists of numerous uncontrolled observational studies. These studies, which are limited methodologically, report that pain and quality of life is improved with the use of infusion pumps.

Severe spasticity

The evidence base consists of case series and a systematic review of case series. The systematic review, published in 2011 by Pin and colleagues, focused on intrathecal baclofen therapy for spasticity and/or dystonia of cerebral origin. (16) The authors identified 16 uncontrolled studies with a total of 227 participants. All of the studies were judged to be of low quality. Most of the outcomes were intermediate measures such as range of motion and muscle strength; several of the studies used objective outcomes. The authors’ interpretation of the studies was that they showed a higher rate of benefit with intrathecal baclofen therapy in patients who were already ambulatory. Adverse events were not consistently defined and reported but appeared to be common. An example of a study that used objective outcomes was published in 2011 by Motta and colleagues in Italy. (17) This study found a statistically significant increase in the Gross Motor Function Measure (GMFM) score after 1 year. 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.

In 2011 (after the Pin et al. literature search), Morton and colleagues in the U.K. published findings of a non-randomized controlled study of intrathecal baclofen therapy in non-ambulant children with severe spastic cerebral palsy. (18) Patients who responded to a one-time test dose of 50 ug intrathecal baclofen were fitted for a pump and placed on a waiting list for surgery. The investigators compared patients who had been on the waiting list between 6-12 months (group 1, n=18) to patients who had undergone surgery (group 2, n=20). The mean time between baseline and outcome assessment was 8.5 months in group 1 and 9.5 months in group 2. There was not a statistically significant difference between the 2 groups in the primary outcome measure, the Pediatric Evaluation of Disability Inventory (PEDI). The authors noted, however, that given the small number of patients recruited, the study was underpowered to detect clinically significant differences between groups on this outcome. Several secondary outcomes favored group 2, including scores on the Modified Ashworth Scale (difference between groups 1.7, p=0.008), scores on the Penn Spasm Scale (difference between groups -1.3, p=0.0010) and the range-of-motion score (difference between groups 8.3, p=0.005).

Implanted infusion pumps for 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

SISTERS: Spasticity in Stroke Study (NCT01032239) (19): 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. The estimated enrollment is 80 patients, and the expected date of completion is January 2014.

Secondary Debulking Surgery with and without Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer (NCT00426257) (20): This is an open-label RCT that is comparing secondary bulking with secondary bulking plus intraperitoneal chemotherapy in patients with stage III ovarian cancer. The primary outcome is duration of recurrence-free survival. The estimated enrollment is 280 patients, and the estimated date of study completion is December 2013.

Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer (CHORINE) (NCT01628380) (21): This is an RCT comparing cytoreductive surgery plus chemotherapy with an intraperitoneal component with cytoreductive surgery-only in patients with stage IIIc epithelial ovarian cancer. The study is being conducted in Italy and is sponsored by Bergmano Hospital. The expected enrollment is 94 patients, and the expected date of study completion is July 2016.

Clinical Input Received through Physician Medical Societies and Academic Medical Centers

In response to requests, input was received through 1 Physician Specialty Society and 3 Academic Medical Centers while this policy was under review in 2012. While the various Physician Specialty Societies and Academic Medical Centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the Physician Specialty Societies or Academic Medical Centers, unless otherwise noted. Clinical input focused on implantable infusion pumps for treating patients with cancer; other potential indications were not addressed. There was consensus that implantable infusion pumps may be considered medically necessary for treating patients with primary liver cancer, metastatic colorectal cancer and epithelial ovarian cancer. Reviewers from 3 of 4 organizations disagreed that implantable infusion pumps are medically necessary for providing chemotherapy in patients with head and neck cancer. There was consensus among reviewers that implantable infusion pumps are investigational for all other uses in cancer patients e.g., chemotherapy for patients with gastric cancer.

Summary

There is a large body of evidence on the use of infusion pumps, but the quality of the literature varies by condition. For patients with colorectal cancer metastatic to the liver, a 2009 meta-analysis of randomized controlled trials found that hepatic arterial infusion of chemotherapy with implanted infusion pumps improves tumor control. For women with primary epithelial ovarian cancer, evidence from randomized controlled trials (RCTs) and a systematic review of RCTs indicates that an intraperitoneal infusion of chemotherapy can lead to improved survival and progression-free survival compared to intravenous chemotherapy only. The benefits of an intraperitoneal chemotherapy must be weighed against the risk of adverse events, which have been found to be higher with an intraperitoneal component of chemotherapy. For patients with chronic cancer pain, a systematic review of RCTs concluded that pain symptoms were less for patients who used an infusion pump. For these 3 indications, the evidence is sufficient to conclude that the use of an implantable infusion pump improves outcomes and therefore may be considered medically necessary.

There is insufficient evidence suggesting that chemotherapy delivered through implantable infusion pumps improves health outcomes for patients with head and neck cancer or gastric cancer. Clinical input did not support use of this technology for these types of cancer. Thus, these indications are considered investigational.

For patients with intractable, non-cancer pain, the evidence consists of uncontrolled studies that report improvements in pain and quality of life following use of an implantable infusion pump. In addition, guidelines from specialty societies support use of infusion pumps for this indication. For patients with severe spasticity, evidence from case series and non-randomized controlled studies reports improvements in symptoms, and there is support from specialty society guidelines for use in spasticity. Because of the strong rationale for use, the suggestive evidence, and the support from clinical guidelines, infusion pumps may be considered medically necessary for chronic, intractable non-cancer pain and for severe spasticity.

Practice Guidelines and Position Statements

The 2012 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.” (22)
  • “The panel recommends that systemic cytotoxic chemotherapy (single agent or combination), intra-arterial chemotherapy, as well as the combination of cytotoxic chemotherapy and radiation therapy be given to patients with unresectable HCC only in the context of a clinical trial.” (23)

The 2012 information summaries from the National Cancer Institute (NCI) state the following:

  • For patients with Stage IV and recurrent colon cancer with liver metastases, hepatic intra-arterial chemotherapy with floxuridine has had higher overall response rates but not a consistent improvement in survival when compared to systemic chemotherapy. (24)
  • For patients with localized and locally advanced unresectable adult primary liver cancer, infusion of chemotherapeutic agents with a subcutaneous portal or implantable pump via a catheter placed in the hepatic artery is described as a standard treatment option. (25)

In 2010, the European Working group for Spasticity in Children published a consensus statement on use of intrathecal baclofen therapy in children with spasticity. (26) 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).

In 2003 (updated 2009), the American Society of Interventional Pain Physicians published evidence-based guidelines on interventions for managing chronic spinal pain. (27) The guidelines state that there is strong evidence to support the use of implantable intrathecal drug administration systems with proper patient selection criteria.

Medicare National Coverage

Medicare provides coverage for implantable infusion pumps for the following indications (28):

  1. Intra-arterial infusion of 5-FUdR for the treatment of liver cancer for patients with primary hepatocellular carcinoma or Duke's Class D colorectal cancer, in whom the metastases are limited to the liver and where the disease is unresectable or the patient refuses surgical excision of the tumor.
  2. Administration of anti-spasmodic drugs intrathecally (e.g., baclofen) to treat chronic intractable spasticity in patients who have proven unresponsive to less invasive medical therapy as determined by the following criteria:
    • As indicated by at least a 6-week trial, the patient cannot be maintained on noninvasive methods of spasm control, such as oral anti-spasmodic drugs, either because these methods fail to control adequately the spasticity or produce intolerable side effects, and
    • Prior to pump implantation, the patient must have responded favorably to a trial intrathecal dose of the anti-spasmodic drug.
  3. Administration of opioid drugs (e.g., morphine) intrathecally or epidurally for treatment of severe chronic intractable pain of malignant or nonmalignant origin in patients who have a life expectancy of at least 3 months and who have proven unresponsive to less invasive medical therapy as determined by the following criteria:
    • The patient's history must indicate that he/she would not respond adequately to non-invasive methods of pain control, such as systemic opioids (including attempts to eliminate physical and behavioral abnormalities that may cause an exaggerated reaction to pain); and
    • A preliminary trial of intraspinal opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequately acceptable pain relief and degree of side effects (including effects on the activities of daily living) and patient acceptance.
  4. Other uses of implanted infusion pumps if:
    • The drug is reasonable and necessary for the treatment of the individual patient;
    • It is medically necessary that the drug be administered by an implanted infusion pump; and
    • The FDA approved labeling for the pump must specify that the drug being administered and the purpose for which it is administered is an indicated use for the pump.

References:

  1. Jarnagin WR, Schwartz LH, Gultekin DH et al. Regional chemotherapy for unresectable primary liver cancer: results of a phase II clinical trial and assessment of DCE-MRI as a biomarker of survival. Ann Oncol 2009; 20(9):1589-95.
  2. Smith GW, Bukowski RM, Hewlett JS et al. Hepatic artery infusion of 5-fluorouracil and mitomycin C in cholangiocarcinoma and gallbladder carcinoma. Cancer 1984; 54(8):1513-6.
  3. Atiq OT, Kemeny N, Niedzwiecki D et al. Treatment of unresectable primary liver cancer with intrahepatic fluorodeoxyuridine and mitomycin C through an implantable pump. Cancer 1992; 69(4):920-4.
  4. 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.
  5. Hoebers FJ, Pluim D, Verheij M et al. Prediction of treatment outcome by cisplatin-DNA adduct formation in patients with stage III/IV head and neck squamous cell carcinoma, treated by concurrent cisplatin-radiation (RADPLAT). Int J Cancer 2006; 119(4):750-6.
  6. Ackerstaff AH, Balm AJ, Rasch CR et al. First-year quality of life assessment of an intra-arterial (RADPLAT) versus intravenous chemoradiation phase III trial. Head Neck 2009; 31(1):77-84.
  7. Jaaback K, Johnson N, Lawrie TA. Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer. Cochrane Database Syst Rev 2011; (11):CD005340.
  8. Markman M, Bundy BN, Alberts DS et al. Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol 2001; 19(4):1001-7.
  9. Matharu G, Tucker O, Alderson D. Systematic review of intraperitoneal chemotherapy for gastric cancer. Br J Surg 2011; 98(9):1225-35.
  10. 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.
  11. 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.
  12. Guyatt G, Gutterman D, Baumann MH et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force. Chest 2006; 129(1):174-81.
  13. 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 Med 2010; 11(7):1010-6.
  14. 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.
  15. 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.
  16. 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.
  17. Motta F, Antonello CE, Stignani C. Intrathecal baclofen and motor function in cerebral palsy. Dev Med Child Neurol 2011; 53(5):443-8.
  18. 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.
  19. Sponsored by Medtronic International Trading Sarl. SISTERS: Spasticity in Stroke Study (NCT01032239). Available online at: www.clinicaltrials.gov. Last accessed July, 2012.
  20. Sponsored by the The Netherlands Cancer Institute. Secondary Debulking Surgery with and without Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer (NCT00426257). Available online at: www.clinicaltrials.gov. Last accessed July, 2012.
  21. Sponsored by Ospedali Riuniti di Bergamo (Italy). Phase 3 Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy in Upfront Treatment of Stage IIIC Epithelial Ovarian Cancer (CHORINE) (NCT01628380). Available online at: www.clinicaltrials.gov. Last accessed July, 2012.
  22. National Comprehensive Cancer Network. Colon Cancer. Clinical practice guidelines in oncology, v.3.2012. 2012. Available online at: http://www.nccn.org/professionals/physician_gls/PDF/colon.pdf. Last accessed July, 2012.
  23. National Comprehensive Cancer Network. Hepatobilliary Cancer. Clinical practice guidelines in oncology, v2.2012. 2012. Available online at: http://www.nccn.org/professionals/physician_gls/PDF/hepatobilliary.pdf.
  24. National Cancer Institute (NCI). Colon Cancer Treatment (PDQ®). Available online at: http://www.cancer.gov/cancertopics/pdq/treatment/colon/HealthProfessional. Last accessed October, 2012.
  25. National Cancer Institute (NCI). Adult Primary Liver Cancer Treatment (PDQ®). Available online at: http://www.cancer.gov/cancertopics/pdq/treatment/adult-primary-liver/HealthProfessional. Last accessed October, 2012.
  26. 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.
  27. American Society of Interventional Pain Physicians. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Updated 2009. Available online at: www.guideline.gov. Last accessed July, 2012.
  28. Centers for Medicare and Medicaid Services. Infusion pumps (280.14). Available online at: www.cms.gov. Last accessed July, 2012.
 

Codes

Number

Description

CPT  36260, 36261, 36262  Insertion, revision, removal of implantable intra-arterial pump code range 
  36563, 36575, 36576, 36581, 36582, 36584, 36585, 36590  Insertion, revision, removal of implantable intravenous infusion pump code range 
  61215  Insertion of subcutaneous reservoir, pump, or continuous infusion system for connection to ventricular catheter 
  62350–62351  Implantation, revision, or repositioning of intrathecal or epidural catheter for implantable reservoir or infusion pump code range 
  62360, 62361, 62362  Implantation or replacement of device for intrathecal or epidural drug infusion code range 
   62365 Removal of subcutaneous reservoir or pump, previously implanted for intrathecal or epidural infusion
   62367-62368 Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status) code range
ICD-9 Procedure  03.90  Insertion of catheter into spinal canal for infusion of therapeutic or palliative substance 
  86.06  Insertion of totally implantable infusion pump 
  38.91  Arterial catheterization 
  38.93  Venous catheterization, not elsewhere classified 
ICD-9 Diagnosis  154.0  Malignant neoplasm rectosigmoid junction 
  155.0  Malignant neoplasm liver, primary 
  155.2  Malignant neoplasm, liver not specified as primary or secondary 
  195.0  Malignant neoplasm head, face, and neck 
  197.7  Malignant neoplasm, liver specified as secondary 
  336.01  Vascular myelopathies 
  340  Multiple sclerosis 
  342.10-342.12 Spastic hemiplegia code range
  343.1  Diplegic 
  343.2  Hemiplegic 
  343.3  Monoplegia 
  343.4  Infantile hemiplegia 
  344.1  Paraplegia 
  344.2  Diplegia of upper limbs 
  344.30-344.32  Monoplegia of lower limb 
  344.40-344.42  Monoplegia of upper limb 
  344.81-344.89  Other specified paralytic syndrome 
  722.83  Post-laminectomy syndrome, lumbar region 
  996.40-996.49 Mechanical complication of internal orthopedic device, implant, and graft 
HCPCS  E0782–E0783  Infusion pump, implantable code range 
  E0786 Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
  A4220  Refill kit for implantable infusion pump 
ICD-10-CM (effective 10/1/14) C00-C14.8 Malignant neoplasm of head and neck code range
   C19 Malignant neoplasm of rectosigmoid junction
   C22.0;C22.2-C22.9 Malignant neoplasm of liver code list
   C76.0 Malignant neoplasm head, face, and neck
   C78.7 Secondary malignant neoplasm of liver
   G95.11-G95.19 Vascular myelopathies
   G35 Multiple sclerosis
   G56.40-G56.42 Causalgia of upper limb
   

G57.70-G57.72

Causalgia of lower limb
   G80.0-G80.9 Cerebral palsy, code range
   G81.10-G81.14 Spastic hemiplegia, code range
   G82.20-G82.22 Paraplegia, code range
   G83.0-G83.9 Other paralytic syndromes, code range
   G89.21-G89.28 Chronic pain, not elsewhere classified, code range
   G89.3 Neoplasm related pain (acute) (chronic)
   G89.4 Chronic pain syndrome
   G90.50-G90.59 Complex regional pain syndrome I, code range
   M96.1 Postlaminectomy syndrome, not elsewhere classified
ICD-10-PCS (effective 10/1/14)   ICD-10-PCS codes are only used for inpatient procedures. This list includes codes for possibly related procedures
   0FH003Z, 0FH033Z, 0FH043Z, 0FH103Z, 0FH133Z, 0FH143Z, 0FH203Z, 0FH233Z, 0FH243Z  Insertion, hepatobiliary system and pancreas, liver (unspecified, right lobe or left lobe), infusion device, open, percutaneous and percutaneous endoscopic approaches, code list  
   0JH60VZ, 0JH63VZ Insertion, subcutaneous tissue and fascia, chest, infusion pump – open and percutaneous approaches, code list  
   0JH70VZ, 0JH73VZ Insertion, subcutaneous tissue and fascia, back, infusion pump – open and percutaneous approaches, code list  
    0JH80VZ, 0JH83VZ Insertion, subcutaneous tissue and fascia, abdomen, infusion pump – open and percutaneous approaches, code list  
    0JHD0VZ, 0JHD3VZ, 0JHF0VZ, 0JHF3VZ, 0JHG0VZ, 0JHG3VZ, 0JHH0VZ, 0JHH3VZ, 0JHL0VZ, 0JHL3VZ, 0JHM0VZ, 0JHM3VZ, 0JHN0VZ, 0JHN3VZ, 0JHP0VZ, 0JHP3VZ Insertion, subcutaneous tissue and fascia, arm or leg, infusion pump – open and percutaneous approaches, code list  
   0JHS03Z, 0JHS33Z Insertion, subcutaneous tissue and fascia, head and neck, infusion device – open and percutaneous approaches, code list  
   0JHT33Z, 0JHT3VZ Insertion, subcutaneous tissue and fascia, trunk, infusion pump – open and percutaneous approaches, code list  
   0JHV03Z, 0JHV33Z, 0JHW03Z, 0JHW33Z Insertion, subcutaneous tissue and fascia, upper or lower extremity, infusion device – open and percutaneous approaches, code list 
  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 Insertion, upper joints (list includes everything in the upper joints from occipital cervical joint to finger), infusion device, open, percutaneous and percutaneous endoscopic approaches, code list 
  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  Insertion, lower joints (list includes everything in the lower joints from lumbar vertebral joint to toe), infusion device, open, percutaneous and percutaneous endoscopic approaches, code list 
Type of Service  Surgery 
Place of Service  Inpatient 

 


Index

 

Implantable Infusion Pumps
Infusion Pumps, Implantable
Pump, Implantable Infusion


Policy History

 

Date Action Reason
11/30/96 Add to Surgery section New policy
4/15/02 Replace policy Policy reviewed by consensus; new review date only
7/17/03 Replace policy Policy no longer scheduled for review
11/9/04 Replace policy Added information on intrathecal infusion, references, and Medicare policy; added intrathecal as a method for pain treatment to the policy statement; otherwise, the policy statement is unchanged.
07/08/10 Replace policy Policy returned to active status; first policy statement revised to indicate that, in order for implantable infusion pumps to be considered medically necessary for severe, chronic intractable pain, patients need to have had a successful trial of spinal opioid or non-opioid analgesics; references 1-8, 10-11 added.
8/11/11 Replace policy Policy reviewed with literature search. In medically necessary policy statement, fourth bullet point changed to say that a temporary trial of pain medication should use the same route of administration as the planned treatment. References 4-5, 8-14 added; other references renumbered/removed.
11/08/13 Replace Policy Policy reviewed with literature search through September 2012. Primary epithelial ovarian cancer (intraperitoneal infusion as component of chemotherapy) added as medically necessary. Head/neck cancers (intra-arterial injection of chemotherapeutic agents) changed to investigational. References 1-3, 5-9, 14-16, 18, 22-25 added; other references renumbered/removed.