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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:

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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).

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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.

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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.

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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.

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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.)