Clinical UM Guideline

This document addresses the use of implantable infusion pumps, including intrathecal pumps, intended to provide long-term, continuous, or intermittent drug infusion. The document does not address implantable reservoirs or implantable infusion systems without a pump.

Note: Please see the following for related information:

• CG-DME-50 Automated Insulin Delivery Systems
• CG-DME-51 External Insulin Pumps

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Medically Necessary:

Implantable infusion pumps are considered medically necessary when used to deliver drugs for the treatment of any of the following conditions:

1. Severe, refractory spasticity of cerebral or spinal cord origin in individuals who are unresponsive to or cannot tolerate oral baclofen (Lioresal^®) therapy (intrathecal injection of baclofen); or
2. Pulmonary arterial hypertension for individuals that have previously been receiving the drug treprostinil (Remodulin^®) via an external infusion pump; or
3. Severe, chronic, intractable pain in individuals who have had a successful trial of opioid or nonopioid analgesics by the same route of administration as the planned treatment (for example, intravenous, intrathecal, or epidural injection). Note: A successful trial is defined as greater than 50% reduction in pain and in the absence of severe adverse events.

Implantable infusion pumps are considered medically necessary when used for intrahepatic artery injection of chemotherapeutic agents for the treatment of:

1. Intrahepatic cholangiocarcinoma; or
2. Metastatic colorectal cancer where metastases are limited to the liver; or
3. Primary liver cancer.

Note: When an implantable infusion pump is determined to be medically necessary, the supplies necessary for the proper use of the pump are considered medically necessary.

Replacement or revision of an implantable infusion pump (which may also involve upgrading to the most current technology) is considered medically necessary when the following have been met:

1. The individual has demonstrated clinical benefit from the pump; and
2. The device is not functioning; or
3. When a built-in system in the pump provides notification of an impending failure; or
4. There are complications such as, but not limited to, infection or implant site pain.

Removal of an implantable infusion pump is considered medically necessary when any of the following have been met:

1. The device is no longer functioning appropriately; or
2. The device is no longer indicated (for example, the device has been determined to be an ineffective, or the individual's condition has improved, resolved, or otherwise changed such that ongoing pump therapy is no longer needed); or
3. There are complications related to the device or implantation site, including but not limited to infection, erosion, catheter malfunction, or implant site pain.

Not Medically Necessary:

Replacement, revision, or upgrades of an implantable infusion pump is considered not medically necessary when the criteria above have not been met, including when requested for convenience or to upgrade to newer technology when the current components remain functional.

Removal of an implantable infusion pump is considered not medically necessary when any the following criteria are met:

1. When the medically necessary criteria above for removal have not been met; or
2. When the intent is to upgrade to newer technology when the current components remain functional.

Implantable infusion pumps are considered not medically necessary for the infusion of heparins for thromboembolic disease or antibiotics for osteomyelitis.

All other uses of implantable infusion pumps, including fully implantable insulin pumps, are considered not medically necessary.

This document describes clinical studies and expert recommendations and explains whether implantable infusion pumps are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Implantable infusion pumps are devices surgically implanted into the body that deliver medicine directly to a specific area of the body over a long period of time. They may be used to treat severe pain, severe muscle stiffness and spasms (spasticity), liver cancers, and a type of high blood pressure in the lungs called pulmonary arterial hypertension. The pump can provide nonstop treatment and may allow lower medicine doses in some cases. Benefits include targeted drug delivery and improved symptom control for some people. Risks include infection, pain at the implant site, problems with the tubing that delivers the drugs, device failure, and complications related to surgery. Some uses have been shown to improve health outcomes while other uses have not been proven to improve health.

What the Studies Show

For severe chronic pain, studies show that delivering pain medicine into the fluid around the spinal cord may reduce pain while using lower doses than medicines taken by mouth. For severe spasticity, studies show that a drug called baclofen (Lioresal^®) delivered through an implantable pump can reduce muscle stiffness and spasms in people who do not improve with oral medications or cannot tolerate them. Studies also show benefits for selected people with liver cancers treated with chemotherapy delivered directly into the liver's blood supply.

Research has also shown that implantable pumps can effectively deliver a drug named treprostinil (Remodulin^®) for some people with pulmonary arterial hypertension who were previously using an external pump outside the body.

Reported risks of implanted infusion pumps include infection, movement of the tubing that delivers the drug, device failure, surgery-related complications, and the need for regular pump refills and up-keep. For some conditions, such as delivery of antibiotics for bone infections or blood-thinning medicines for blood clotting disorders, studies have not shown better health outcomes than standard treatments like oral medications or external infusion pumps. Better studies are needed to know if fully implantable insulin pumps improve health. Unnecessary treatments can lead to treatment that does not help and may cause harm.

When is an Implantable Infusion Pump Clinically Appropriate?

Implantable infusion pumps may be appropriate in these situations:

• Primary liver cancer treated with chemotherapy delivered into the liver artery.
• Colorectal cancer that has spread only to the liver, treated with chemotherapy delivered into the liver artery.
• Intrahepatic cholangiocarcinoma, a cancer of the bile ducts within the liver, treated with chemotherapy delivered into the liver artery.
• Severe spasticity caused by a brain or spinal cord condition when oral baclofen (Lioresal^®) has not worked or cannot be tolerated.
• Pulmonary arterial hypertension in people who were already receiving treprostinil (Remodulin^®) through an external infusion pump
• Severe, long-lasting pain that has not improved with other treatments, when a trial of pain medicine delivered by the planned route has reduced pain by more than 50%.

Replacement or revision of a pump may be appropriate when:

• The person has benefited from the pump; and
• The pump is not working properly, or the pump warns of an upcoming failure, or there are complications such as infection or pain at the implant site.

Removal of a pump may be appropriate when:

• The device is no longer working correctly; or
• The treatment has not been effective; or
• There are complications such as infection or pain at the implant site.

When is this not Clinically Appropriate?

Implantable infusion pumps are not clinically appropriate in the following situations:

• Replacement, revision, or upgrade requests that do not meet the criteria above, including requests made only for convenience or to obtain newer technology when the current pump is still working.
• Delivery of heparin medicines for blood clotting disorders.
• Delivery of antibiotics for osteomyelitis, which is a bone infection.
• Fully implantable insulin pumps.
• Any use not listed in the clinically appropriate section above.

Studies have not shown that implantable pumps provide better health outcomes than standard treatment for blood clotting disorders treated with heparin or for osteomyelitis treated with antibiotics. The risks of surgery, infection, device problems, and ongoing maintenance are not outweighed by proven benefits for these uses. For fully implantable insulin pumps, better studies are needed to know if they improve health.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:
For the procedure codes listed below for all other diagnoses not specified as not medically necessary

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for the following diagnoses, or for situations designated in the Clinical Indications section as not medically necessary.

Note: the following codes describing placement of a catheter or reservoir when billed as part of the infusion pump system implantation would be considered medically necessary when the pump is medically necessary. This document does not apply if the codes are billed as a subsequent service to pump implantation or when not associated with an implantable pump.

Summary:

Implantable infusion pumps are fully enclosed, programmable medical devices designed for the chronic, controlled delivery of therapeutic agents directly into an individual’s body. These devices are surgically implanted subcutaneously, and are connected to a catheter system that delivers medication to a targeted anatomical site such as the intrathecal space, epidural space, peritoneal cavity, or intravenous system. Implantable infusion pumps are recommended by several medical societies, including the American Society of International Pain Physicians (ASIPP), the National Comprehensive Cancer Network (NCCN), the National Multiple Sclerosis Society (NMSS), the North American Spine Society (NASS), and the Polyanalgesic Consensus Conference (PACC). Implantable infusion pumps are typically indicated for, but not limited to, chronic pain management (for example, intrathecal opioid delivery), spasticity treatment (for example, intrathecal baclofen therapy), chemotherapy (for example, hepatic arterial infusion), and parenteral nutrition and hormone therapy in select cases.

The role of opioid therapy in treatment of pain is well established in the medical literature. Individuals who have proven unresponsive to less invasive medical therapy and who require large doses of opioids may be candidates for an implantable delivery system that permits intrathecal administration. This system delivers the opioid directly to the receptors in the spinal cord, allowing smaller doses to be used and thereby minimizing side effects. A preliminary trial of an intraspinal opioid drug is administered using a temporary intrathecal/epidural catheter (continuous infusion or bolus injection) to confirm adequate pain relief and acceptable degree of side effects. This position is supported by multiple case control studies.

Discussion:

Implantable Infusion Pumps

The implantable infusion pump is a drug delivery system that provides continuous infusion of an agent at a constant and precise rate. The purpose of an implantable infusion pump is to deliver therapeutic levels of a drug directly to a target organ or compartment. Implantable infusion pumps come in both programable and non-programmable forms. Implantable infusion pumps are surgically placed in a subcutaneous pocket under the infraclavicular fossa or in the abdominal wall and a catheter is threaded into the desired position. A drug is infused over an extended period of time. 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 therapeutic drugs. A heparinized saline solution may also be used during an interruption of drug therapy to maintain catheter patency.

There is a range of totally implanted catheters with implanted reservoirs and manual pumps as well as totally implanted catheters with implanted infusion pumps. Implantable infusion pumps are available in either programmable or non-programmable models, depending on the type of medication delivery required. Programmable pumps are for flexible medication delivery as dose titration and regulation will vary due to the dynamic nature of the individual. Programmable designs facilitate flexible dosing options and precise dose titration over time.

An example of a flexible medication delivery pump is the SynchroMed^® electronic pump, manufactured by Medtronic Inc. (Minneapolis, MN, USA). This pump contains a collapsible reservoir that can be filled with 10 to 18 ml of liquid medication and a peristaltic pump that pushes the medication through a bacteriostatic filter and catheter into the spinal canal. The SynchroMed II Infusion system is indicated to deliver prescribed medication for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. The infusion system has a battery life of 5-7 years with a maximum shut-down design to ensure that the pump provides proper administration of intrathecal therapy. The pump has a built in elective replacement indicator (ERI), this alarm sounds when the pump is nearing the end of service (EOS). The pump will no longer operate 90 days after the alarm has sounded, a pump replacement is recommended to avoid interruption in service and risk of withdrawal of baclofen. The U. S. Food and Drug Administration (FDA) issued a Class I recall in September 2011 due to the potential for reduction of battery performance in the SynchroMed II pump. Codman & Shurtleff, Inc. (Raynham, MA), manufacturer of Medstream™ Programmable Infusion System received FDA premarket supplement for the implantable infusion pump and catheter system for use with baclofen in the treatment of severe spasticity.

Programmable Infusion Pumps

Medtronic Inc. (Minneapolis, MN) and United Therapeutics Corp. (Research Triangle Park, NC) received FDA approval for the Implantable System for Remodulin^®. The system is comprised of the SynchroMed II Pump programmable implantable drug delivery system and a newly developed intravascular catheter to deliver Remodulin intravenously for adults with pulmonary arterial hypertension (Class I, II, and III) who were receiving Remodulin via continuous intravenous infusion with an external infusion pump. The FDA approval was based on data reported from the DellVery for Pulmonary Arterial Hypertension (PAH) clinical study (NCT01321073), a prospective, single-arm, nonrandomized, open-label multicenter study, by Waxman (2017). The trial enrolled 64 adults with PAH (World Health Organization group 1); 4 exited the study prior to device implantation, and the remaining 60 participants had successful implant procedures. The study showed the implantable intravascular delivery system was an effective option for delivery of treprostinil (Remodulin), with a low rate of catheter-related complications, and a high rate of participant satisfaction. Clinically significant implant procedure-related complications included one pneumothorax, two infections unrelated to catheter placement, and one episode of atrial fibrillation. Three catheter dislocations in 2 participants occurred early in the trial; catheters were removed and replaced via surgical procedure. In conclusion:

Procedural success was demonstrated: 100% of the attempted implant procedures were successfully completed. PAH therapy, anticoagulation, and other comorbidities were safely managed during the surgical procedure and postoperatively. The implant procedure was successfully performed with a low complication rate by clinicians with diverse range of specialty training.

Non-programmable Infusion Pumps

Non-programmable pumps are for fixed rate medication delivery when the dosage is expected to be stable. Possible routes of administration include intravenous, intrahepatic, intra-arterial, subcutaneous, intraperitoneal, intrathecal, epidural, and intraventricular.

Implantable infusion pumps for intrathecal use

Implantable infusion pumps for the delivery of intrathecal (intraspinal) opiates is based on the existence of opioid (narcotic) receptors on the spinal cord to achieve “selective spinal analgesia” (pain relief). Pumps provide long-term delivery of opioid (narcotic) medication in the management of malignant (cancer) pain and nonmalignant (non-cancer) pain. Examples of appropriate nonmalignant pain syndromes which may be treated with implantable pumps include “failed back surgery,” chronic arachnoiditis, visceral pain syndromes, post herpetic neuralgia, phantom limb pain, spinal cord injuries, peripheral neuropathies and reflex sympathetic dystrophy. A successful temporary trial of spinal opiates is required both to evaluate analgesic responsiveness and to increase the long-term success of the procedure. Individuals must be closely monitored as conversion from high dose oral or systemic opioids to spinally administered opioids will sometimes result in withdrawal symptoms.

The 2013 American Society of Interventional Pain Physicians (ASIPP) guidelines state that intrathecal infusion systems may be used for chronic non-cancer pain that persists despite treatment, including pain that continues after surgery (post-surgery syndrome).

The 2026 NCCN Adult Cancer Pain Guidelines (V.2.2026) recommend regional infusions of opioids, local anesthetics, clonidine, and ziconotide via implanted intrathecal pumps to minimize the distribution of drugs to receptors in the brain. This also lowers serum opioid levels, which may avoid the adverse effects of systemic administration. The guidelines states:

Regional infusion of analgesics (epidural, intrathecal, and regional plexus) minimizes the distribution of drugs to receptors in the brain, as well as lowering serum opioid levels, potentially avoiding adverse effects of systemic administration. The intrathecal route of opioid administration should be considered in patients with intolerable sedation, confusion, constipation, and/or inadequate pain management with systemic opioid administration. This approach is a valuable tool to improve analgesia for patients who have pain from a variety of anatomical locations (for example, head and neck, upper and lower extremities, trunk). However, due to the risk of catheter migration and infection risk, consider limiting the duration of use to several days.

Treatment with this therapy should remain a last resort, used only after all other appropriate therapies have failed. A permanently implantable drug-infusion system is not usually appropriate when life expectancy is 3 months or less; for such individuals, external drug infusion systems can appropriately provide spinal analgesia and comparable pain relief.

In 2024, the Polyanalgesic Consensus Conference (PACC^®), in collaboration with the International Neuromodulation Society (INS), convened a multidisciplinary expert panel to review evidence published between 2017 and 2024 and develop updated consensus recommendations regarding the use of intrathecal drug delivery systems (IDDS) for chronic noncancer pain (Deer, 2024). The recommendations address patient selection, safety, efficacy, pharmacologic management, implantation practices, and long-term therapy optimization. The panel concluded that intrathecal drug delivery should be considered a later-line treatment option for carefully selected individuals with severe chronic pain who have not achieved adequate relief with, or are unable to tolerate, more conservative therapies. The updated recommendations place increased emphasis on comprehensive selection criteria, including psychological evaluation, assessment of substance use risk, establishment of functional treatment goals, shared decision-making, and identification of comorbidities that may increase the risk of complications. The guidance also emphasizes opioid stewardship and supports the use of non-opioid intrathecal therapies when clinically appropriate. Specifically, ziconotide continues to be recommended as an important first-line intrathecal medication for many individuals because it is not associated with opioid-related adverse effects such as tolerance, dependence, opioid-induced hyperalgesia, or respiratory depression. PACC further emphasizes that end-of-life individuals are not automatically appropriate candidates for intrathecal therapy and that factors such as prognosis, comorbidities, psychosocial circumstances, and goals of care should be carefully evaluated. CMS coverage guidance distinguishes between terminal malignant pain and chronic nonmalignant pain.

The NCCN Central Nervous System Cancers Guidelines (V3.2026) support the use of intrathecal chemotherapy for primary central nervous system lymphoma when cancer is present in the cerebrospinal fluid (CSF) or detected on spinal MRI. The guidelines also support intrathecal chemotherapy for leptomeningeal metastases associated with non-small cell lung cancer (NSCLC) and melanoma. However, intrathecal chemotherapy for primary central nervous system lymphoma and leptomeningeal metastases is generally administered intermittently via lumbar puncture or an implanted ventricular access device (Ommaya reservoir). Continuous drug delivery using an implantable infusion pump is not considered standard practice for the administration of intrathecal chemotherapy in these conditions. Contemporary oncology guidelines primarily describe bolus intrathecal administration through ventricular or lumbar access rather than implantable infusion pump systems.

Current hospice and palliative care literature does not identify dedicated hospice-specific national guidelines for implantable infusion pumps. Available guidance from palliative care organizations, the PACC and CMS supports the use of intrathecal drug delivery systems in carefully selected individuals with refractory cancer pain or severe chronic pain IDDS when consistent with the individual's goals of care. Recommendations emphasize consideration of prognosis, psychosocial factors, access to ongoing pump maintenance and refills, coordination between hospice and specialty providers, and avoidance of abrupt therapy interruption due to the risk of withdrawal or loss of symptom control. For individuals with terminal cancer, CMS recognizes that progression to more invasive pain-management modalities, including implanted pumps, may occur more rapidly and with less emphasis on behavioral interventions because of the severity of disease and limited prognosis.

Implantable pumps for delivery of medication to the intrathecal space are also used as an alternative to chronic systemic administration for the treatment of spasticity of cerebral or spinal origin. These pumps have been demonstrated in numerous randomized controlled trials to reduce adverse effects such as tolerance, dependency, and neurotoxicity.

In 2017, the NASS published coverage policy recommendations addressing the use of spinal IDDS for the treatment of pain and spasticity caused by spinal pathology. The use of IDDS to treat pain and spasticity is established in the literature. IDDS are typically considered when other therapies have failed. The NASS clinical indications include the following recommendations:

Nonmalignant Pain:

1. Severe chronic pain caused by verifiable spinal pathology with clinical manifestations known to be associated with the underlying condition.
2. Patient has failed or could not tolerate other treatment methods including but not limited to nonopioid medications, physical therapy and appropriate interventional (nonsurgical) treatments.
3. Patient has demonstrated compliance with previous attempts to treat their condition.
4. Demonstrable improvement of pain and function with systemic opiates and development of intolerable side effects, tolerance, or hyperalgesia.
5. Psychosocial evaluation to rule out active drug and alcohol disorders and psychiatric conditions.
6. Patient is not a candidate for other surgical interventions.
7. Patient agrees to a 50% reduction in systemic opiates prior to undergoing an IT opiate trial. While undergoing the IT trial there is ≥50% decrease in pain with a concomitant increase in function.
8. Patients who have had a successful trial agree to continue to taper their systemic opioids.
9. Candidates have undergone a trial of IT treatment with at least 50% improvement in symptoms.

Spasticity:

IDDS are indicated for the treatment of severe spasticity when either of the following conditions are met:

1. Patients with severe spasticity who either fail to respond to oral baclofen or develop intolerable side-effects to the medication.
2. Patient has a baseline average Ashworth score of at least 3 and a Spasm Frequency score of at least 2 and demonstrates at least a 2-point reduction in the Ashworth or Spasm Frequency score for 4 hours following an intrathecal trial bolus of baclofen.

Additionally the NMSS supports intrathecal baclofen pump therapy for severe spasticity that cannot be effectively managed with oral medications.

Otero-Luis (2023) conducted a systematic review and meta-analysis evaluating the effectiveness of intrathecal baclofen administered via an implantable infusion pump for the treatment of spasticity of various etiologies. The review included 27 studies, of which 11 were included in the quantitative meta-analysis. Participants included both children and adults with spasticity associated with conditions such as cerebral palsy, hereditary spastic paraplegia, traumatic or hypoxic brain injury, and other neurologic disorders. The pooled analysis demonstrated that intrathecal baclofen therapy significantly reduced spasticity as measured by the Modified Ashworth Scale (MAS) in both adults (mean difference [MD], -1.54; 95% confidence interval [CI], -1.80 to -1.27) and children (MD, -0.70; 95% CI, -0.91 to -0.49). Significant improvements were observed in upper extremity spasticity (MD, -1.12; 95% CI, -1.86 to -0.38), lower extremity spasticity (MD, -1.45; 95% CI, -1.93 to -0.97), and combined upper and lower extremity spasticity (MD, -1.30; 95% CI, -1.58 to -1.02), with the greatest benefit observed in the lower extremities. Meta-regression analyses suggested that younger age and longer treatment duration were associated with greater treatment effects. The authors concluded that intrathecal baclofen delivered through an implantable infusion pump is effective in reducing severe spasticity across multiple neurologic conditions and may improve quality of life and ease of care. However, the findings should be interpreted cautiously because of substantial study heterogeneity, small sample sizes, and a high risk of bias in many of the included studies. The authors noted that additional high-quality randomized controlled trials are needed to further establish long-term effectiveness and generalizability.

Current evidence supports the use of intrathecal baclofen delivered by an implantable infusion pump for the management of severe, refractory spasticity associated with a variety of neurologic disorders when less invasive treatments have been ineffective or not tolerated. Evidence demonstrates clinically meaningful reductions in spasticity, particularly in the lower extremities, with greater benefit observed in younger individuals and with longer treatment duration.

Hepatic Artery Infusion Chemotherapy (HAIC):

Implantable infusions pumps are frequently used to deliver chemotherapy directly to the hepatic artery or superior vena cava.

The use of continuous chemotherapy infusion treatment has been studied for individuals with primary hepatic cancer and metastatic colorectal cancer to the liver. This method of chemotherapy infusion has been found to improve medical outcomes in select individuals where continuous chemotherapy is believed to be appropriate. The evidence supporting this conclusion includes multiple randomized controlled trials. Prospective randomized trials of individuals with unresectable liver disease have shown that compared to conventional systemic therapy, hepatic artery infusion is associated with an increased tumor response rate.

In 2023, Hu completed a meta-analysis to examine if adjuvant hepatic artery infusion of chemotherapy improved outcomes for individuals with hepatocellular carcinoma (HCC) following liver resection. The primary outcomes measured were overall survival and disease-free survival. The analysis included 11 studies (2 randomized controlled trials and 9 retrospective studies) which included 1290 individuals; 513 individuals were treated with liver resection and adjuvant HAIC, and 777 individuals were treated with liver resection only. The results demonstrated that adjuvant HAIC improved overall survival rate (p<0.01) and disease-free survival (p<0.01) respectively. A sub-analysis showed that individuals with portal vein invasion or microvascular invasion benefit from adjuvant HAIC in overall survival (p<0.01 and p=0.0373, respectively), and disease-free survival (p<0.01 and p=0.0125, respectively). Adjuvant HAIC with the oxaliplatin-based approach improved overall survival (p=0.02 and p<0.01, respectively). The authors concluded that postoperative adjuvant HAIC in individuals with HCC with portal vein invasion or microvascular invasion is clinically beneficial, however, it is not clear whether HAIC may improve the survival outcome in all individuals with HCC after liver resection.

Cao (2024) published a meta-analysis that investigated better first-line treatments for unresectable HCC. The study was based on data from 13 phase III RCTs that evaluated the safety and efficacy of triple therapy compared to a retrospective single-center study with 442 participants that received angiogenesis inhibitors plus programmed cell death of protein 1 [PD-1], and its ligand PD-L1 blockades (also known as AIPB) treatment only. A total of 176 HCC individuals included in the analysis received triple therapy, defined as HAIC combined with inhibitors, from January 2018 to April 2023. The median age in both groups was 55.0 years, and all the participants were evaluated as having an Eastern Cooperative Oncology Group (ECOG) ranging from 0-1 and received an average 5.08 rounds of HAIC in the triple therapy group. The results demonstrated that both HAIC alone and with AIPB were effective treatments (HAIC p=0.95; and HAIC + AIPB, p=0.04). However, the triple therapy group (n=88) had a longer median overall survival, 31.6 months, compared to the AIPB group (n=88), 14.6 months (p<0.001), as well as higher incidence of adverse events 94.3% compared to 75.4%, respectively (p<0.001). The authors concluded that triple therapy is more effective for unresectable HCC than AIPB alone.

The NCCN Biliary Tract Cancer Guidelines V1.2026 state that HAIC, with or without systemic chemotherapy, may be considered for selected individuals with intrahepatic cholangiocarcinoma in a clinical trial or at experienced centers. The NCCN Colon Cancer V2.2026 and Rectal Cancer V2.2026 Guidelines recommend HAIC for certain people with colorectal cancer that has spread to the liver, including those with unresectable liver metastases or resectable liver metastases that have a high risk of recurrence.

Other considerations:

Several studies have evaluated interventions that combine radiotherapy and concomitant intra-arterial cisplatin, otherwise known as RADPLAT for treatment of head and neck cancer. Ackerstaff (2009) reported results from a randomized multicenter study that examined 17 quality-of-life scale assessments after treatment with radiotherapy with intravenous or intra-arterial cisplatin. A total of 207 participants with advanced head and neck cancer were included in the study. Quality-of-life symptoms reported between both groups were similar. The only statistically significant difference reported between groups was the nausea/vomiting scale at 7 weeks, at which time the rate of symptoms was higher in the intravenous compared to the intra-arterial population. Current evidence has not demonstrated a clear advantage of intra-arterial chemotherapy delivery via an intra-arterial catheter compared to intravenous chemotherapy in combination with radiotherapy for individuals with advanced head and neck cancer (Rasch, 2010). Clinical trials are underway to explore the use of intra-arterial chemotherapy in locally advanced squamous cell carcinoma.

The use of implantable pumps for infusion of antithrombotic medications for thromboembolic disease, or for the infusion of antibiotics for osteomyelitis, has not been demonstrated to provide any additional improvement in net health outcomes above standard care with bolus or subcutaneous drug administrations. This therapy does not prevent the occurrence of complications or morbidity, nor does it significantly relieve pain over other less invasive treatment methods. The risks involved in the implantation and maintenance of implantable infusion pumps for these conditions is not outweighed by any potential benefits. The evidence supporting this conclusion includes multiple case series studies.

Fully Implantable Insulin Pumps

The Medtronic MiniMed^® 2017, an implantable insulin pump was the most recent device investigated in clinical trials but it was never FDA-approved. At the time of this writing, no implantable insulin pumps have received FDA approval for marketing.

Fully implantable insulin pumps are designed to deliver insulin via intraperitoneal or intravenous routes in a programmed and controlled manner to diabetics. However, these pumps have been associated with a high incidence of device malfunction related to catheter obstruction, among other malfunctions. Newer devices are under development that are expected to drastically reduce the problem of catheter obstruction. With additional refinements underway, implantable insulin pumps may eventually prove beneficial in the treatment of insulin dependent diabetics. To show benefit, however, additional long-term randomized prospective studies are needed.

There is ongoing research in implantable systems and closed-loop artificial pancreas systems, some of which may include implantable components (for example continuous glucose monitors or experimental insulin reservoirs), but these are still in development stages.

Bacteriostatic: An agent that inhibits the growth or multiplication of bacteria.

Bolus: A large dose of a drug given intravenously for the purpose of rapidly achieving the needed therapeutic concentration in the bloodstream.

Hepatic colorectal metastases: Colorectal cancer that has spread from its site of origin to the liver.

Infraclavicular fossa: A triangular depression bounded by the clavicle and the adjacent borders of the deltoid and pectoralis major muscles.

Intra-arterial therapies (IAT): A group of cancer treatments that deliver concentrated doses of cancer-killing medicine directly to the affected area; they may be used to occlude arterial blood supply to a tumor, to deliver a high local concentration of chemotherapy, and/or to deliver tumor-selective radiation.

Intrathecal space: The space between the spinal cord and the surrounding membrane, which is filled with cerebrospinal fluid.

Osteomyelitis: Inflammation of the bone due to infection.

Parenteral: Refers to the administration of medications, fluids, or nutrition into the body through routes that bypass the gastrointestinal (digestive) tract, such as by injection as in subcutaneous, intramuscular, or intravenous.

Primary liver cancer: A cancer that originates from liver cells, as opposed to having spread from other organs.

Peer Reviewed Publications:

1. 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.
2. Cao YZ, Zheng GL, Zhang TQ, et al. Hepatic arterial infusion chemotherapy with anti-angiogenesis agents and immune checkpoint inhibitors for unresectable hepatocellular carcinoma and meta-analysis. World J Gastroenterol. 2024; 30(4):318-331.
3. Hu L, Zheng Y, Lin J, et al. Does adjuvant hepatic artery infusion chemotherapy improve patient outcomes for hepatocellular carcinoma following liver resection? A meta-analysis. World J Surg Oncol. 2023; 21(1):121.
4. Otero-Luis I, Saz-Lara A, Cavero-Redondo I, et al. Effectiveness of the intrathecal baclofen pump in the treatment of spasticity of different aetiologies: A systematic review and meta-analysis. Neurologia (Engl Ed). 2025; 40(6):577-585.
5. Pak LM, Kemeny NE, Capanu M, et al. Prospective phase II trial of combination hepatic artery infusion and systemic chemotherapy for unresectable colorectal liver metastases: Long term results and curative potential. J Surg Oncol. 2018; 117(4):634-643.
6. Prager J, Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain. 2001; 17(3):206-214.
7. Rasch CR, Hauptmann M, Schornagel J, et al. Intra-arterial versus intravenous chemoradiation for advanced head and neck cancer: Results of a randomized phase 3 trial. Cancer. 2010; 116(9):2159-2165.
8. Skitzki JJ, Chang AE. Hepatic artery chemotherapy for colorectal liver metastases: technical considerations and review of clinical trials. Surg Oncol. 2002; 11(3):123-135.
9. Smith TJ, Staats PS, Deer T, et al. Implantable Drug Delivery Systems Study Group. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002; 20(19):4040-4049.
10. Waxman AB, McElderry HT, Gomberg-Maitland M, et al. Totally implantable IV treprostinil therapy in pulmonary hypertension assessment of the implantation procedure. Chest. 2017; 152(6):1128-1134.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society of Anesthesiologists, Inc. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010; 112(4):810-833.
2. American Society of Anesthesiologists. Advocacy Topics. Improving access to high quality care. Summary CDC guidelines for prescribing opioids for pain. Last update December 22, 2022. Available at: https://www.asahq.org/advocacy-and-asapac/advocacy-topics/improving-access-to-high-quality-pain-care/summary-cdc-guidelines-for-prescribing-opioids-for-pain. Accessed on August 14, 2026.
3. American Society of International Pain Physicians (ASIPP). Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Updated 2013. Available at: https://asipp.org/ipm-practice-guidelines/. Accessed on August 14, 2026
4. Centers for Medicare and Medicaid Services. National Coverage Determination for Infusion Pumps. NCD #280.14. Effective December 17, 2004. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=223&ncdver=2&SearchType=Advanced&CoverageSelection=National&NCSelection=NCA%7cCAL%7cNCD%7cMEDCAC%7cTA%7cMCD&KeyWord=infusion&KeyWordLookUp=Doc&KeyWordSearchType=Exact&kq=true&bc=IAAAACAAAAAAAA%3d%3d&. Accessed on August 14, 2026.
5. Deer TR, Hayek SM, Grider JS, et al. The Polyanalgesic Consensus Conference (PACC^®): Intrathecal drug delivery guidance on safety and therapy optimization when treating chronic noncancer pain. Neuromodulation. 2024; 27(7):1107-1139.
6. Deer TR, Hayek SM, Pope JE, et al. The Polyanalgesic Consensus Conference (PACC^®): Recommendations for Trialing of Intrathecal Drug Delivery Infusion Therapy. Neuromodulation. 2017; 20(2):133-154.
7. NASS Coverage Committee, Glaser J, Kreiner S, et al. The North American Spine Society. NASS coverage policy recommendations on intrathecal drug delivery systems. Updated March 2017. Available at: https://www.spine.org/coverage. Accessed on August 14, 2026.
8. NCCN Clinical Practice Guideline in Oncology^™ (NCCN). © 2026 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on August 17, 2026.
   • Adult Cancer Pain (V.2.2026). Revised July 13, 2026.
   • Biliary Tract Cancers (V.1.2026). Revised March 10, 2026.
   • Colon Cancer (V.2.2026). Revised April 7, 2026.
   • Hepatocellular Carcinoma (V.1.2026). Revised March 10, 2026.
   • Rectal Cancer (V.2.2026). Revised April 7, 2026.
   • Central Nervous System Cancers (V3.2026). Revised August 17, 2026.
9. U.S. Food and Drug Administration (FDA). Medical Devices. Implantable System for Remodulin - P140032. December 22, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140032. Accessed on August 14, 2026.
10.  U.S. Food and Drug Administration (FDA). Medical Devices. Intera 3000 Hepatic Artery Infusion Pump- P890055. March 11, 1996. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P890055. Accessed on August 14, 2026.
11. U.S. Food and Drug Administration (FDA). Medical Devices. Premarket Approval (PMA) P860004 S380. December 21, 2021. Medtronic^® SynchroMed^™ Infusion System Ascenda Intrathecal Catheters. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/TextResults.cfm?dls=11&q=UDg2MDAwNA==&pf=0&pn=10&sc=. Accessed on August 14, 2026.

1. National Cancer Institute (NCI). Available at: http://www.cancer.gov/types. Accessed on August 14, 2026.
   • Primary liver cancer treatment (PDQ^®) - Health Professional. Updated April 17, 2025.
   • Colon cancer treatment (PDQ) - Health Professional. Updated February 12, 2025.
2. National Cancer Institute (NCI). What is Liver Cancer. Treatment. Available at: https://www.cancer.gov/types/liver/what-is-liver-cancer/treatment#_543. Updated May 8, 2025. Accessed on August 14, 2026.
3. National Multiple Sclerosis Society (NMSS). MS/Symptom & Diagnosis/MS Symptoms/Spasticity. Available at: http://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms/Spasticity. Accessed on August 14, 2026.

Drug Infusion Pumps
HAI
Hepatic Arterial Infusion
Implantable Infusion Pumps
Intrathecal Baclofen for Spasticity
Intrathecal Drug Delivery System
Venous Access Device, Implantable

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.