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Clinical Policy Title: Implantable infusion pumps
Clinical Policy Number: 00.02.14
Effective Date: July 1, 2016
Initial Review Date: May 18, 2016
Most Recent Review Date: April 10, 2018
Next Review Date: April 2019
Related policies:
CP# 00.02.06 Infusible pharmaceuticals for bone pain management
CP# 03.03.01 Spinal cord stimulators for chronic pain
CP# 03.03.08 Intravenous lidocaine infusion for neuropathic pain
CP# 06.02.01 Insulin infusion therapy (insulin pumps)
ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.
Coverage policy
AmeriHealth Caritas considers the use of implantable infusion pumps as durable medical equipment to
be medically necessary when all of the following criteria and indications are met:
The infused drug is medically necessary for the treatment of the member.
The implantable infusion pump is medically necessary to administer the drug.
U.S. Food and Drug Administration (FDA)-approved labeling for the pump specifies that the drug
being administered and the purpose for which it is administered is an indicated use for the
pump.
The implantable infusion pump is administered by providers who can fully accommodate all
aspects of implantable infusion pump drug delivery, including evaluation, trialing, implantation,
long-term management, and troubleshooting.
Policy contains:
Chronic pain.
Chronic spasticity and dystonia.
Diabetes mellitus.
Intrathecal infusion.
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Indications for use:
Implantable infusion pumps are considered medically necessary for the following conditions:
For 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: (1) the disease cannot be resected or, (2) the patient refuses
surgical excision of the tumor.
For administration of anti-spasmodic drugs (e.g., baclofen) intrathecally to treat chronic
intractable spasticity in patients who have proven unresponsive to less invasive medical therapy.
Specifically, this lack of responsiveness is indicated by at least a six-week trial in which the
patient cannot be maintained on non-invasive methods of spasm control, such as oral anti-
spasmodic drugs, because these methods either fail to adequately control the spasticity or
produce intolerable side effects. Prior to pump implantation, the patient must have responded
favorably to a trial intrathecal dose of the anti-spasmodic drug. The procedure is not indicated
for children who are too small to accommodate an infusion pump (NICE, 2012).
To administer 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 three months, and who have proven unresponsive to less invasive medical
therapy, including patient history indicating they would not respond adequately to noninvasive
methods of pain control, such as systemic opioids. A preliminary trial of intraspinal opioid drug
administration must be undertaken with a temporary intrathecal/epidural catheter to
substantiate adequately acceptable pain relief, degree of side effects (including effects on
activities of daily living), and patient acceptance.
For insulin-dependent type 1 or insulin-requiring non-insulin-dependent type 2 diabetes mellitus
when glycemic control with intensive subcutaneous insulin therapy is not achieved.
Determinations may be made on coverage of other uses of implanted infusion pumps if the attending
physician concludes:
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.
FDA-approved labeling for the pump specifies that the drug being administered and the purpose
for which it is administered is an indicated use for the pump (Centers for Medicare & Medicaid
Services [CMS] National Coverage Determination [NCD], 2004).
For Medicare members only:
In addition to the above-listed indications, AmeriHealth Caritas considers the use of implantable
infusion pumps as durable medical equipment to be clinically proven and, therefore, medically
necessary for members who meet the following criteria and indications:
For administration of intrahepatic floxuridine-based chemotherapy for the treatment of primary
hepatocellular carcinoma.
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For intrathecal administration of morphine or ziconotide monotherapy for severe chronic
intractable pain of malignant or nonmalignant origin in patients who have a life expectancy of at
least three months and who have proven unresponsive to less invasive medical therapy.
Limitations:
All other uses of implantable infusion pumps are not medically necessary.
Contraindications include, but are not limited to:
Inability or unwillingness to have the pump refilled, including inadequate social support.
Presence of other implanted programmable devices, since crosstalk between devices may
inadvertently change the prescription.
Significant coagulopathies.
Hemodynamic instability.
Spinal anomalies.
Intracranial hypertension.
Active infection.
Insufficient body size preventing device implantation.
Significant psychiatric comorbidities.
Allergy to drug being infused.
Documentation in the medical record must include medical necessity for both the drug and intrathecal
or hepatic-artery-based infusion, successful trialing, and continued drug administration using the
implantable infusion pump.
Replacement or upgrade of an implantable infusion pump or programmer is not medically necessary
unless either:
The existing device malfunctions and cannot be repaired.
The individual’s condition changes in a way that makes the present device nonfunctional.
Replacement of the entire implantable infusion pump system (i.e., the catheter and programmer) is not
generally required at the time of pump replacement due to the end of battery life.
Alternative covered services:
Noninvasive, nonpharmacologic interventions (e.g., physical therapy, occupational therapy, or
counseling).
Oral medications (e.g., nonsteroidal anti-inflammatory drugs, antidepressants, anticonvulsants,
serotonergic drugs, baclofen, opioids, benzodiazepines, dantrolene sodium, or imidazolines).
Systemic chemotherapy.
Botulinum toxin injections.
Stimulation techniques.
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Regional anesthetic interventions.
Surgery.
Background
Implantable infusion pumps are subcutaneously inserted devices that deliver drugs through central
venous, intra-arterial, intraspinal (epidural or intrathecal), or intraperitoneal catheters. An implantable
infusion pump is intended to provide long-term continuous or intermittent drug infusion directly to
specific sites and can be programmed for continuous or variable rates of infusion. The 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. Implantable infusion pumps are easily removable, thus providing
an important degree of therapeutic control for patients and providers.
The FDA regulates implantable infusion pumps as combination products, which comprise two or more
regulated components (e.g., drugs, devices, and/or biological products), through the premarket
approval process. The FDA has approved several implantable infusion pumps for use with specific drugs
for targeted neuromodulation and cancer treatment. The treatments are:
Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate
sterile solution for the treatment of chronic intractable pain.
Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management
of severe chronic pain.
Chronic intrathecal infusion of Lioresal® IT (baclofen injection) for the management of severe
spasticity.
Chronic intravascular infusion of floxuridine or methotrexate for the treatment of primary or
metastatic cancer.
Professional guidelines exist for various uses of implantable infusion pumps. For cancer-related pain,
one such guideline is a recommendation for much wider use of intrathecal infusion for pain
management for terminal illness, or if standard medication management fails to adequately control pain
(Deer, 2011). For chemotherapy patients, guidelines recommend hepatic artery-based infusion with or
without systemic 5-FU as an option at institutions with experience in both the surgical and medical
oncologic aspects of the procedure (National Comprehensive Cancer Network [NCCN], 2016a; NCCN,
2016b).
An American Society for Interventional Pain Physicians guideline for continuous intrathecal infusion to
alleviate chronic spinal pain provides strong evidence for short-term relief and moderate evidence for
long-term improvement (Boswell, 2007). There are concerns that guidelines for such treatment of
chronic spinal pain are based on a paucity of literature (Manchikanti, 2009b). Guidelines exist on
intrathecal baclofen therapy for spasticity. One recommends a screening test prior to intrathecal
baclofen therapy for spasticity as a best practice (Boster, 2016). Another guideline for problematic
spasticity involving muscles, including neurologic diseases, finds the treatment can be effective in
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certain ambulatory patients who have failed other approaches, and is also effective in managing
children (Saulino, 2016). Several European professional societies recommend intrathecal baclofen to
treat spasticity in selected multiple sclerosis patients (Gold, 2013).
The Quality Standards Subcommittee of the American Academy of Neurology and the Practice
Committee of the Child Neurology Society found insufficient evidence to support or refute the use of
continuous intrathecal baclofen for the treatment of spasticity in children with cerebral palsy (Delgado,
2010). The National Institute for Health and Care Excellence recommends considering intrathecal
baclofen for children and young people with spasticity or dystonia that causes difficulty with pain or
muscle spasms, posture or function, or self-care or ease of care by parents or caregivers (NICE, 2012).
Contraindications to intrathecal baclofen for spasticity (including known adverse reactions to the drug
and other factors affecting compliance) have also been presented (Saulino, 2016).
Continuous subcutaneous insulin infusion therapy is recommended as a treatment option for adults and
children 12 and older with type 1 diabetes mellitus, as long as attempts to reduce HbA1C levels with
daily injections result in disabling hypoglycemia, or if HbA1C levels remain high. For children under 12
with type 1 diabetes, continuous therapy is recommended if multiple injections are considered
inappropriate (NICE, 2008). Another guideline states that trials have yet to confirm an association
between oral opioids and response to intrathecal therapy, or a basis for treating diabetes-related pain
(Deer, 2011). The Society of Critical Care Medicine asserts that compelling evidence is lacking to
recommend for or against continuous insulin infusion (AHRQ, 2012).
Searches
AmeriHealth Caritas searched PubMed and the databases of:
UK National Health Services Centre for Reviews and Dissemination.
Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other
evidence-based practice centers.
CMS.
We conducted searches on February 27, 2018. Search terms were: "infusions, parenteral," "infusion
pumps, implantable," "intrathecal clonidine," "intrathecal ziconotide," and "intrathecal baclofen."
We included:
Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and
greater precision of effect estimation than in smaller primary studies. Systematic reviews use
predetermined transparent methods to minimize bias, effectively treating the review as a
scientific endeavor, and are thus rated highest in evidence-grading hierarchies.
Guidelines based on systematic reviews.
Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost
studies), reporting both costs and outcomes — sometimes referred to as efficiency studies —
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which also rank near the top of evidence hierarchies.
Findings
A number of systematic reviews have been conducted on continuous implantable infusion pumps. For
various types of (non-cancer) pain, one such review of seven trials (none randomized) found a paucity of
evidence to support use (Falco, 2013). A review of intrathecal infusion for chronic intractable pain
included 15 trials (none randomized) of 12 months’ follow-up for pain, concluding the devices had
positive outcomes for long-term relief (Patel, 2009).
A review found insufficient evidence to compare intrathecal infusion with other types of long-term relief
for chronic spinal pain (Manchikanti, 2009a). A review of eight trials, none randomized, found
intrathecal baclofen for spinal cord injury reduced spasticity, using limited strength of evidence
(McIntyre, 2014). A systematic review of three studies measuring a visual analogue scale of pain
intensity after use of ziconotide, a new non-opioid calcium channel blocker for chronic neuropathic pain,
documented a significant pooled odds ratio of 2.77 (Brookes, 2017).
A recommendation for using intrathecal infusion for cancer-related pain for over 12 months based on a
literature review is limited to moderate, based on the moderate quality of evidence (Hayek, 2011). The
value of locoregional chemotherapy treatment with hepatic artery-based infusion for patients with non-
resectable intrahepatic cholangiocarcinoma is unclear (NCCN, 2016c).
A meta-analysis of 20 articles (n = 657) of patients with non-resectable intrahepatic cholangiocarcinoma
indicated that hepatic arterial infusion produced superior survival results compared to other treatments
(Boehm, 2015). Another study of 10 randomized trials did not support continuous therapy of hepatic
arterial infusion alone to treat liver metastases from colorectal cancer (Mocellin, 2009). A 2016
Cochrane review of nine trials (n = 2119) of ovarian cancer patients found survival improvements if an
intraperitoneal infusion therapy was added to chemotherapy (Jaaback, 2016).
Numerous systematic reviews and meta-analyses address efficacy of continuous infusion of insulin for
persons with diabetes mellitus. One Cochrane study found no difference in maternal and infant
outcomes for pregnant women given continuous insulin infusion compared to daily multiple insulin
injections, based on five trials with 154 patients (Farrar, 2016), which validated an earlier analysis
(Mukhopadhyay, 2007). Another Cochrane study of 976 participants with type 1 diabetes in 23 reviews
indicated continuous infusion had significantly reduced HbA1C levels (Misso, 2010). Continuous infusion
with implantable insulin pumps (four trials and eight cohorts) was found to be effective in lowering
HbA1C levels and reducing hypoglycemic events, as well as raising patient satisfaction (Spaan, 2014). A
review of children younger than age 6 with type 1 diabetes diagnosed more than six months before
study (n = 176) documented significant improvements in HbA1C and more than 50 percent decreases in
hypoglycemia in five of seven studies (Churchill, 2009).
A review of 15 moderate-quality trials comparing continuous subcutaneous insulin infusion with
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multiple daily injections for type 1 diabetes indicated slightly lower HbA1C for the continuous infusion
group and no difference in hypoglycemia; adolescents and adults with type 1 diabetes had fewer minor
hypoglycemia episodes (not significant), and there was no difference in the number of hypoglycemia
episodes in patients with type 2 diabetes (Fatourechi, 2009). A similar review of 16 randomized
controlled trials (RCTs) showed the continuous group was superior in reduced HbA1C, reduced swings in
blood glucose, fewer hypoglycemic episodes, and improved quality of life (Cummins, 2010).
A Hayes review last updated in 2015 assigned a “B” rating to the efficacy of implantable, continuous
insulin pumps for patients with type 1 or 2 diabetes mellitus who have not otherwise achieved glycemic
control, or for type 2 patients (Hayes, 2015).
A recent review of multiple sclerosis patients given intrathecal baclofen and intrathecal phenol showed
a positive effect on severe spasticity, although evidence is limited (Otero-Romero, 2016). A systematic
review of 16 studies, most low level, of intrathecal baclofen therapy in ambulant adults with spasticity of
cerebral origin noted some improvement, but methodological limits and common adverse events led
authors to conclude that use of this therapy is not supported (Pin, 2011). A 2015 Cochrane review found
some short-term evidence that intrathecal baclofen effectively reduces spasticity in children with
cerebral palsy (Hasnat, 2015), as did a Hayes review (Hayes, 2009).
A review of 430 children who underwent intrathecal baclofen therapy and were tracked for an average
of 8.6 years showed 25 percent had at least one complication, and five percent had multiple
complications. A total of 9.3 percent experienced an infection, a rate significantly lower (p < .001) in
patients whose pump was placed subfascially versus subcutaneously. A higher infection rate was
observed after pump replacement compared with the first pump implantation (10.6 percent versus 6.0
percent) (Motta, 2014).
There is a growing body of information on the pharmacokinetics and pharmacodynamics of infusion
therapy. One review summarized the current information on intrathecal baclofen therapy, which is
helpful to clinicians for drug concentration, infusion regimens, localization of catheter tip, and
management of tolerance (Heetla, 2014).
Policy updates:
A total of one guideline/other and two peer reviewed references were added to, and four
guidelines/other removed from, this policy in February 2018.
A total of nine guidelines/other and 15 peer reviewed references were added to this policy, in 2017.
Summary of clinical evidence:
Citation Content, Methods, Recommendations
Brookes (2017)
Key points:
8
Citation Content, Methods, Recommendations
Ziconotide monotherapy for
chronic neuropathic pain
Systematic review and meta-analysis of three RCTs.
Overall quality: moderate with a moderate risk of bias.
Frequent serious adverse events that resulted in two studies revising the protocol.
Pooled odds ratio (ziconotide versus placebo) 2.77.
Results suggest ziconotide is beneficial for pain reduction for chronic neuropathic pain.
Boehm (2015)
Comparative effectiveness
of hepatic artery-based
therapies (HATs) for
unresectable intrahepatic
cholangiocarcinoma (ICC)
Key points:
Meta-analysis of 20 studies (n = 657 patients) of hepatic arterial infusion, transcatheter
arterial chemoembolization, drug-eluting bead transcatheter arterial chemoembolization
and yttrium (90) radioembolization.
Median overall survival (months): hepatic arterial infusion (22.8); yttrium (90)
radioembolization (13.9); transcatheter arterial chemoembolization (12.4); and drug-
eluting bead transcatheter arterial chemoembolization (12.3).
Complete and partial response to therapy (rate): hepatic arterial infusion (56.9 percent);
yttrium (90) radioembolization (27.4 percent); and transcatheter arterial
chemoembolization (17.3 percent).
Grade III/IV toxicity (events per patient): hepatic arterial infusion (0.35); transcatheter
arterial chemoembolization (0.26); and drug-eluting bead transcatheter arterial
chemoembolization (0.32).
For patients with unresectable ICC treated with hepatic artery-based therapy, hepatic
arterial infusion offered the best outcomes in tumor response and survival, but may be
limited by toxicity.
Falco (2013)
Long-term management of
chronic non-cancer pain
using IT opioids
Key points:
Systematic review of seven non-randomized studies (n = 767).
Quality assessment: low to moderate.
Limited evidence for short-term and long-term pain relief and functional improvement in
the treatment of chronic nonmalignant pain.
Hayek (2011)
IT infusions used in long-
term management (> six
months) of chronic pain
Key points:
Systematic review of 20 studies: 15 observational studies for non-cancer pain and five
studies (four observational, one RCT) for cancer pain. Eleven studies assessed
intrathecal morphine alone or in combination with other analgesics; four studies
assessed other analgesics, including ziconotide.
Overall quality: moderate (high for the one RCT).
Intrathecal therapy is moderately effective and safe in controlling refractory painful
conditions that have failed multiple other treatment modalities, both in cancer-related
and non-cancer-related conditions.
Complications: granuloma formation, catheter kinking, fracture/leakage and migration,
cerebrospinal fluid leak, seroma, hygroma, infection, pump erosion through the skin,
and medication side effects.
Jaaback (2011)
Cochrane review
IP chemotherapy for the
Key points:
Systematic review and meta-analysis of nine RCTs (n = 2,119 women) comparing
intraperitoneal versus intravenous administration.
Overall quality: high (for six RCTs).
9
Citation Content, Methods, Recommendations
initial management of
primary epithelial ovarian
cancer
Overall survival (hazard ratio): 0.81(eight RCTs, 2,026 women); disease-free interval
(HR): 0.78(five RCTs, 1,311 women).
Intraperitoneal route was associated with greater serious toxicity (gastrointestinal
effects, pain, fever, and infection) but less ototoxicity than intravenous route.
Clinical trials needed to address optimal dose, timing, and mechanism of administration.
Mocellin (2009)
Cochrane review
FUDR-based HAI versus
systemic chemotherapy
(SCT) for unresectable liver
metastases from colorectal
cancer (CRC)
Key points:
Systematic review and meta-analysis of 10 RCTs (n = 1,277 patients).
Overall quality: moderate to high.
Tumor response rate: 42.9 percent and 18.4 percent for hepatic arterial infusion and
systemic chemotherapy, respectively (RR = 2.26; P < 0.0001).
Mean weighted median overall survival times: 15.9 and 12.4 months for hepatic arterial
infusion and systemic chemotherapy, respectively: meta-risk of death was not
statistically different between groups (HR = 0.90;; P = 0.24).
Evidence does not support the clinical or investigational use of floxuridine-based hepatic
arterial infusion alone for the treatment of patients with unresectable colorectal cancer
liver metastases; superior tumor response rate of hepatic arterial infusion regimen does
not translate into a survival advantage over systemic chemotherapy.
References
Professional society guidelines/other:
Boster AL, Bennett SE, Bilsky GS, et al. Best practices for intrathecal baclofen therapy: screening test.
Neuromodulation. 2017;19(6):616 – 22.
Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in
the management of chronic spinal pain. Pain Physician. 2007;10(1):7 – 111.
Deer TR, Pope JE, Hayek SM, et al. The polyanalgesic consensus conference (PACC): recommendations
on intrathecal drug infusion systems best practices and guidelines. Neuromodulation. 2017;20(2):96 –
132.
Deer TR, Smith HS, Burton AW, et al. Comprehensive consensus based guidelines on intrathecal drug
delivery systems in the treatment of pain caused by cancer pain. Pain Physician. 2011;14(3):E283 – 312.
Delgado MR, Hirtz D, Aisen M, et al. Practice parameter: pharmacologic treatment of spasticity in
children and adolescents with cerebral palsy (an evidence-based review): report of the Quality
Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the
Child Neurology Society. Neurology. 2010;74(4):336 – 43. [Reaffirmed 2013.]
Gold R, Oreja-Guevara C. Advances in the management of multiple sclerosis spasticity: multiple sclerosis
spasticity guidelines. Expert Rev Neurother. 2013;13(12 Suppl):55 – 59.
10
Jacobi J, Bircher N, Krinsley J, et al. Guidelines for the use of an insulin infusion for the management of hyperglycemia in critically ill patients. Crit Care Med. 2012;40(12):3251 – 76.
Manchikanti L, Boswell MV, Singh V, et al. Comprehensive evidence-based guidelines for interventional
techniques in the management of chronic spinal pain. Pain Physician. 2009b;12(4):699 – 802.
National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Colon cancer. NCCN:
Version 2.2016 (a). www.nccn.org. Accessed February 27, 2018.
National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Rectal cancer. NCCN:
Version 2.2016 (b). www.nccn.org. Accessed February 27, 2018.
National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Hepatobiliary
Cancers. NCCN: Version 1.2016 (c). www.nccn.org. Accessed February 27, 2018.
National Institute for Health and Care Excellence (NICE). Continuous subcutaneous insulin infusion for
the treatment of diabetes mellitus. Technology appraisal guidance. NICE: July,
2008.https://www.nice.org.uk/guidance/ta151. Accessed February 27, 2018.
National Institute for Health and Care Excellence (NICE). Spasticity in children and young people with
nonprogressive brain disorders: management of spasticity and co-existing motor disorders and their
early musculoskeletal complications. NICE: July 2012. Last updated November 2016.
http://guidance.nice.org.uk/CG145. Accessed February 27, 2018.
Oregon Health and Science University (OHSU), Gynecologic Oncology Division. Nursing Guidelines.
Intraperitoneal Chemotherapy Administration. http://www.ohsu.edu/xd/education/schools/school-of-
medicine/departments/clinical-departments/ob-gyn/divisions/upload/Nursing-Guidelines-
Intraperitoneal-Chemotherapy-Administration.pdf. Accessed February 27, 2018.
Rodbard HW, Blonde L, Braithwaite SS, et al. American Association of Clinical Endocrinologists medical
guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007;13 Suppl 1:1
– 68.
Saulino M, Ivanhoe CB, McGuire JR, Ridley B, Shilt JS, Boster AL. Best practices for intrathecal baclofen
therapy: patient selection. Neuromodulation. 2016;19(6):607 – 15.
Peer-reviewed references:
Boehm LM, Jayakrishnan TT, Miura JT, et al. Comparative effectiveness of hepatic artery based therapies
for unresectable intrahepatic cholangiocarcinoma. J Surg Oncol. 2015; 111(2): 213 – 20.
11
Brookes ME, Eldabe S, Batterham A. Ziconotide monotherapy: A systematic review of randomised
controlled trials. Curr Neuropharmacol. 2017;15(2):217 – 31.
Churchill JN, Ruppe RL, Smaldone A. Use of continuous insulin infusion pumps in young children with
type 1 diabetes: a systematic review. J Pediatr Health Care. 2009;23(3):173 – 79.
Cummins E, Royle P, Snaith A, et al. Clinical effectiveness and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes: systematic review and economic evaluation. Health Technol Assess. 2010;14(11): 1 – 181.
Falco FJ, Patel VB, Hayek SM, et al. Intrathecal infusion systems for long-term management of chronic
non-cancer pain: an update of assessment of evidence. Pain Physician. 2013;16(2 Suppl): SE185 – 216.
Farrar D, Tuffnell DJ, West J, West HM. Continuous subcutaneous insulin infusion versus multiple daily
injections of insulin for pregnant women with diabetes. Cochrane Database Syst Rev.
2016;(6):CD005542. Doi: 10.1002/14651858.CD005542.pub3.
Fatourechi MM, Kudva YC, Murad MH et al. Hypoglycemia with intensive insulin therapy: a systematic
review and meta-analyses of randomized trials of continuous subcutaneous insulin infusion versus
multiple daily injections. J Clin Endocrinol Metab. 2009;94(3):729 – 40.
Hasnat MJ, Rice JE. Intrathecal baclofen for treating spasticity in children with cerebral palsy. Cochrane
Database Syst Rev. 2015;(11):CD004552. Doi: 10.1002/14651858.CD004552.pub2.
Hayek SM, Deer TR, Pope JE, Panchal SJ, Patel VB. Intrathecal therapy for cancer and non-cancer pain.
Pain Physician. 2011;14(3): 219 – 48.
Hayes, Inc. Implantable infusion pumps. Lansdale, PA: Hayes, Inc., May 12, 2015 (latest annual review).
Hayes, Inc. Intrathecal baclofen for cerebral palsy. Lansdale, PA: Hayes, Inc., December 17, 2009 (latest
annual review).
Heetla HW, Staal MJ, Proost JH, van Laar T. Clinical relevance of pharmacological and physiological data
in intrathecal baclofen therapy. Arch Phys Med Rehabil. 2014;95(11):2199 – 206.
Jaaback K, Johnson N, Lawrie TA. Intraperitoneal chemotherapy for the initial management of primary
epithelial ovarian cancer. Cochrane Database Syst Rev. 2016;(1):CD005340. Doi:
10.1002/14651858.CD005340.pub4.
Manchikanti L, Boswell MV, Datta S, et al. Comprehensive review of therapeutic interventions in
managing chronic spinal pain. Pain Physician. 2009a;12(4):E123 – 98.
12
McIntyre A, Mays R, Mehta S, et al. Examining the effectiveness of intrathecal baclofen on spasticity in
individuals with chronic spinal cord injury: a systematic review. J Spinal Cord Med. 2014;37(1):11 – 18.
Misso ML, Egberts KJ, Page M, O’Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII)
versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev.
2010;(1):CD005103. Doi: 10.1002/14651858.CD005103.pub2.
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. Doi: 10.1002/14651858.CD007823.pub2.
Motta F, Antonello CE. Analysis of complications in 430 consecutive pediatric patients treated with intrathecal baclofen therapy: 14-year experience. J Neurosurg Pediatr. 2014;13(3):301 – 06.
Mukhopadhyay A, Farrell T, Fraser R, Ola B. Continuous subcutaneous insulin infusion vs. intensive
conventional insulin therapy in pregnant diabetic women: a systematic review and meta analysis of
randomized, controlled trials. Am J Obstet Gynecol. 2007;197(5):447 – 56.
Otero-Romero S, Sastre-Garriga J, Comi G, et al. Pharmacological management of spasticity in multiple
sclerosis: systematic review and consensus paper. Mult Scler. 2016;22(11):1386 – 96.
Patel VB, Manchikanti L, Singh V, Schultz DM, Hayek SM, Smith HS. Systematic review of intrathecal
infusion systems for long-term management of chronic non-cancer pain. Pain Physician. 2009;12(2):345
– 60.
Pin TW, McCartney L, Lewis J, Waugh MC. Use of the 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.
Saulino M, Kim PS, Shaw E. Practical considerations and patient selection for intrathecal drug delivery in
the management of chronic pain. J Pain Res. 2014;7:627 – 38.
Spaan N, Teplova A, Stam G, Spaan J, Lucas C. Systematic review: continuous intraperitoneal insulin
infusion with implantable insulin pumps for diabetes mellitus. Acta Diabetol. 2014;51(3):339 – 51.
CMS NCDs:
280.14 Infusion Pumps. Effective date December 17, 2004. http://www.cms.gov/medicare-coverage-
database/details/ncd-details.aspx?NCDId=223&ver=2. Accessed February 27, 2018.
Local Coverage Determinations (LCDs):
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L33593 Implantable Infusion Pump for the Treatment of Chronic Intractable Pain. Effective date October
1, 2015. http://www.cms.gov/medicare-coverage-database/details/lcd-
details.aspx?LCDId=33593&ver=3. Accessed February 27, 2018.
Local Coverage Articles (LCAs):
A55239 Implantable Infusion Pumps for Chronic Pain. Effective Date September 1, 2016.
https://www.cms.gov/medicare-coverage-database/details/article-
details.aspx?articleId=55239&ver=10&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Al
l&KeyWord=implantable+infusion+pumps&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAA
ACAAAAAA&. Accessed February 27, 2018.
A55323 Implantable Infusion Pumps for Chronic Pain. Effective Date September 1, 2016.
https://www.cms.gov/medicare-coverage-database/details/article-
details.aspx?articleId=55323&ver=5&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All
&KeyWord=implantable+infusion+pumps&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAA
ACAAAAAA&. Accessed February 27, 2018.
Commonly submitted codes
Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is
not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and
bill accordingly.
CPT Codes Description Comments
36260 Insertion of implantable intra-arterial infusion pump (e.g., for chemotherapy of
liver)
36261 Revision of implanted intra-arterial infusion pump
36563 Insertion of tunneled centrally inserted central venous access device with
subcutaneous pump
36583 Replacement, complete, of a tunneled centrally inserted central venous access
device, with subcutaneous pump, through same venous access
61215 Insertion of subcutaneous reservoir, pump or continuous infusion system for
connection to ventricular catheter
62350
Implantation, revision or repositioning of tunneled intrathecal or epidural
catheter, for long-term medication administration via an external pump or
implantable reservoir/infusion pump; without laminectomy
62351
Implantation, revision or repositioning of tunneled intrathecal or epidural
catheter, for long-term medication administration via an external pump or
implantable reservoir/infusion pump; with laminectomy
62360 Implantation or replacement of device for intrathecal or epidural drug infusion;
subcutaneous reservoir
62361 Implantation or replacement of device for intrathecal or epidural drug infusion;
nonprogrammable pump
62362 Implantation or replacement of device for intrathecal or epidural drug infusion;
14
CPT Codes Description Comments
programmable pump, including preparation of pump, with or without
programming
ICD-10 Codes Description Comments
C18.0 - C21.8 Malignant neoplasm of colon, rectosigmoid junction, rectum, anus and anal
canal
C22.0 Liver cell carcinoma
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
G25.82 Stiff-hyphenman syndrome
G35 Multiple sclerosis
G80.0 - G80.9 Cerebral palsy
G81.10 - G81.14 Spastic hemiplegia
G82.20 - G82.22 Paraplegia
G82.50 -G82.54 Quadriplegia
G89.0 Central pain syndrome
G89.21 - G89.29 Chronic pain, not elsewhere classified
G89.3 Neoplasm related pain (acute) (chronic)
G89.4 Chronic pain syndrome
G95.11 - G95.19 Vascular myelopathies
M62.40 - M62.49 M62.830 -
M62.838
Spasm of muscle
R25.0 - R25.9 Abnormal involuntary movements
R26.0 - R26.1,
R26.81 - R26.9
Abnormalities of gait and mobility
S12.000+ -
S12.001+
S12.100+ -
S12.101+
S12.200+ -
S12.201+
S12.300+ -
S12.301+
S12.400+ -
S12.401+
S12.500+ -
S12.501+
S12.600+ -
S12.601+
Fracture of vertebral column with spinal cord injury
15
ICD-10 Codes Description Comments
S14.101+ -
S14.107+
S14.111+ -
S14.117+
S14.121+ -
S14.127+
S14.131+ -
S14.137+
S14.151+ -
S14.157+
S14.101+ -
S14.139+
S14.151+ -
S14.159+
Injury of nerves and spinal cord at neck level
HCPCS
Level II Codes Description Comments
C1772 Infusion pump, programmable (implantable)
C1891 Infusion pump, nonprogrammable, permanent (implantable)
C2626 Infusion pump, nonprogrammable, temporary (implantable)
E0782 Infusion pump, implantable, nonprogrammable (includes all components, e.g.,
pump, catheter, connectors, etc.)
E0783 Infusion pump system, implantable, programmable (includes all components,
e.g., pump, catheter, connectors, etc.)