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Insertion of Implantable Infusion Pumps
11.15.03m

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY
​
 The insertion of implantable infusion pumps is considered medically necessary and, therefore, covered when used for one or more of the following indications or conditions:

CHEMOTHERAPY FOR CANCER
The insertion of implantable infusion pumps is considered medically necessary and, therefore, covered for the following indications:
  • Intra-arterial infusion of 5-fluorodeoxyuridine (5-FUdR) for the treatment of liver cancer for individuals with primary hepatocellular carcinoma or Stage IVA metastatic colorectal cancer according to the American Joint Committee on Cancer (AJCC) staging system, in which metastases are limited to the liver (one site)​, and when one of the following criteria​ are met:
    • ​​​The disease is unresectable 
    • The individual refuses surgical excision of the tumor​
ANTISPASMODIC DRUGS FOR SEVERE SPASTICITY
The insertion of implantable infusion pumps is considered medically necessary and, therefore, covered for the intrathecal administration of antispasmodic drugs (e.g., baclofen) to treat chronic intractable spasticity in individuals who have proven unresponsive to less invasive medical therapy, as determined when all​ of the following criteria are met:
  • The individual cannot be maintained on noninvasive methods of spasm control, such as oral antispasmodic drugs, either because these methods fail to control the spasticity adequately or they produce intolerable side effects, as indicated by at least a six-week trial.
  • Prior to pump implantation, the individual must have responded favorably to a trial intrathecal dose of the antispasmodic drug.​
OPIOID DRUGS FOR THE TREATMENT OF CHRONIC INTRACTABLE PAIN
The insertion of implantable infusion pumps is considered medically necessary and, therefore, covered for the intrathecal or epidural administration of opioid drugs (e.g., morphine) to treat severe, chronic, intractable pain of a malignant or nonmalignant origin in individuals who have a life expectancy of at least three months and who have proven unresponsive to less invasive medical therapy, as determined when all of the following criteria are met:
  • The individual's history must include an inadequate response to noninvasive methods of pain control (e.g., systemic opioids and attempts to eliminate physical and behavioral abnormalities that may cause an exaggerated reaction to pain).
  • A preliminary trial of intraspinal opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequately acceptable pain relief, the degree of side effects (including effects on the activities of daily living), and individual acceptance. These must be documented in the medical record.
OTHER USES​
Determinations may be made on the medical necessity of other uses of implantable infusion pumps if when all of the following criteria are met:
  • The drug is medically necessary for the treatment of the individual.
  • The drug can only be administered by an implantable infusion pump.
  • The drug being administered and the purpose for its administration are consistent with the indicated uses in the pump's FDA-approved labeling.
The revision, replacement, and/or removal of implantable infusion pumps or catheters that are required for the pump are considered medically necessary for the individual's treatment and, therefore, covered.

CONTRAINDICATIONS
The insertion of implantable infusion pumps is contraindicated for individuals with one or more of the following indications:
  • A known allergy or hypersensitivity to the drug being administered (e.g., baclofen or morphine)
  • An infection
  • Insufficient body size to support the weight and bulk of the device
  • Other implanted programmable devices (because cross-talk between devices may inadvertently change the prescription)
NOT MEDICALLY NECESSARY

The insertion of implantable infusion pumps​ are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury:
  • The use of any medication not identified in the implanted pump labeling for an intrathecal infusion to treat or manage pain (e.g. hydromorphone, bupivacaine, fentanyl, clonidine)
  • ​The mixture of two or more different kinds of medications for administration through the implanted pump for intrathecal infusion to treat or manage pain
  • The use of any compounded medication in the implanted pump for intrathecal infusion to treat or manage pain​​​​​
REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must reflect the medical necessity of the care and services provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

An order for each item billed must be signed and dated by the professional provider who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.​

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, insertion of implantable infusion pumps is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved several implantable infusion pumps under the 510(k) process.

Description

Implantable infusion pumps are devices intended to deliver medication and fluids, via an implanted catheter, to a targeted anatomical location for an extended amount of time. Pumps are periodically refilled by a healthcare provider, and may be fixed-rate or programmable. Fixed-rate pumps are set by the manufacturer to infuse at a constant rate. These machines cannot be controlled by the clinician and dosing is altered only by adjusting the medication concentration. By contrast, programmable pumps can be manipulated by the user to perform a variety of infusion strategies. These pumps allow for more complex delivery schedules, in that dosing and flow rates can be altered, and they allow for patient-controlled bolus delivery. Programmable pumps are more commonly used in current practice. An implantable infusion pump consists of the following two parts:
  • A surgically placed catheter that administers the prescribed medication via the distal end of the catheter
  • A pump that has a reservoir for medication storage
An implantable infusion pump is surgically placed in a subcutaneous tissue pocket in the abdomen or chest. Drug administration routes include the following:
  • Intravenous/Intravascular (into a vein/blood vessel)
  • Intra-arterial (into an artery)
  • Intraperitoneal (within the peritoneal cavity)
  • Intrathecal (within the spinal canal)
  • Intraventricular (within a ventricle)
  • Subcutaneous (beneath the skin)
Implantable infusion pump devices may be used for the treatment of chronic pain, muscle spasticity, and other conditions, and are often sought when conservative medical management has been ineffective. This policy describes medical necessity for a wide range of indications, including for the delivery of oncologic drugs, analgesic drugs, and spasticity drugs.

HEPATIC CHEMOTHERAPY

Infusion of chemotherapeutic drugs directly into the hepatic artery at a constant rate, known as hepatic arterial infusion (HAI), can occur when an infusion pump is surgically implanted in the abdomen, with the catheter delivering medication into the hepatic artery. HAI chemotherapy is a favored treatment approach due to the effective delivery of high concentrations of cytotoxic agents directly to liver metastases with minimal systemic toxicity. Tumor cells from gastrointestinal malignancies, particularly colorectal cancer, spread through the blood via the portal circulation, the circulatory path to the liver from the small intestine, colon, and spleen. This makes the liver the first site of metastases in the majority of patients, such that direct treatment of hepatic metastases may prevent tumor dissemination to other sites.

A number of chemotherapy drugs are available for the treatment of liver cancer and colorectal cancer (e.g. gemcitabine, oxaliplatin, doxorubicin, 5-fluorouracil, cisplatin). For use in HAI chemotherapy, the ideal agent is 5-fluoro-2’-deoxyuridine (i.e. 5-fluorodeoxyuridine, floxuridine, 5-FUdR, FUDR), due to its high dose-response curve, high extraction rate, and rapid total-body clearance post-infusion. 5-FUdR administered via HAI has been confirmed to result in 16-fold higher concentration in hepatic tumors as compared to venous administration. Intravenous infusion, which distributes the medication systemically via the general circulation, is also an option for treatment of colorectal cancer.

NEUROMODULATION OF SPASTICITY

Spasticity, a condition in which certain muscles are continuously contracted, is typically caused by damage to the areas of the central nervous system which control voluntary movement. As a result, there is a change in the balance of signals between the nerves and the muscles, which leads to increased activity in the muscles. Treatment options vary depending upon etiology and case severity, with intrathecal administration of the drug baclofen as an option for severe cases of intractable spasticity. Baclofen, a gamma-aminobutyric acid receptor agonist, helps reestablish inhibitory cortical influences on spinal cord interneurons. It received FDA approval in 1992 for the intrathecal treatment of spasticity of spinal origin, after having shown to be highly effective in reducing spasticity and associated pain, particularly in the extremities, with fewer side effects that oral medication treatment. Individuals with spasticity receiving intrathecal administration of baclofen via an implantable infusion pump may experience a reduction in rigidity and muscle spasms.

NEUROMODULATION OF PAIN

Pain may be the result of a number of conditions, ranging from those which are primarily neuropathic in origin, such as ankylosing spondylitis, to illnesses such as cancer or sickle cell disease, in which pain is a symptom of the underlying, non-neurologic disease. As defined by the American Chronic Pain Association, chronic pain is ongoing or recurrent pain, lasting beyond the usual course of acute illness or injury, or more than 3-6 months, and which adversely affects the individual’s well-being. In the case of individuals with intractable chronic pain that is refractory to standard medical management, intrathecal drug delivery systems can be used for continuous administration of pain medication. FDA-approved medication, including morphine and ziconotide, is delivered directly into the cerebrospinal fluid by way of implanted catheter; because the agent is administered at the pain source, less is required than via the oral administration route, which reduces systemic side effects. Morphine for intrathecal use in implantable infusion pumps is available as Infumorph® and Mitigo™, which are preservative-free, injectable morphine sulfate formulations specifically for intrathecal or epidural infusion by a continuous microinfusion device. The single ziconotide intrathecal infusion product available is marketed by Elan Pharmaceuticals as Prialt® and is intended for continuous delivery via a surgically implanted infusion system.

FDA ADVISORY

In 2018, the FDA released a communication regarding the risk of using non-approved medications for intrathecal pump pain management, reiterating that only specific pain medications are permitted to be used for each pump. Because the central nervous system is highly sensitive to preservatives and infectious agents (e.g. bacteria and viruses), analgesics delivered via cerebrospinal fluid must meet additional safety standards to be granted FDA approval. As such, it is important that only drugs approved for use with a specific infusion pump be used for that pump. Although individual patients may experience some relief from using pain medications not approved for intrathecal administration in their implanted pumps, such use may create additional risks including dosing errors, pump failures, and other safety concerns. Improper use of non-approved medications used with implanted infusion pump may lead to patient symptoms such as pain, opioid withdrawal, fever, vomiting, muscle spasm, cognitive changes, weakness, and cardiac and respiratory distress. Due to the high risk of adverse events, the use of non-approved pain medications with intrathecal drug delivery systems is deemed not medically necessary.

The only FDA-approved medicines for intrathecal infusion to treat or manage painExamples of medicines not identified in the implanted pump labeling for intrathecal infusion to treat or manage pain
INFUMORPH® (morphine sulfate), preservative free, injectable solution

MITIGO™ (morphine sulfate), preservative free, injectable solution

*PRIALT® (preservative free ziconotide sterile solution)

Medicines not FDA approved for intrathecal administration or intrathecal implanted pump use (for example, hydromorphone, bupivacaine, fentanyl, clonidine)

ANY mixture of two or more different kinds of medicines

Any compounded medicine (for example, to achieve higher concentration or different formulation of an FDA approved medicine)

* The current labeling (Instructions for Use) of the implanted pump should be reviewed because not all pumps are currently approved for use with PRIALT.

(Adapted from US Food and Drug Administration: "FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices​ Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication".)​

AMERICAN JOINT COMMITTEE ON CANCER (AJCC) TUMOR, NODE, METASTASIS (TNM) STAGING SYSTEM (Pulled staging system from policy ATEZOLIZUMAB)​

According to the American Joint Committee on Cancer (AJCC), the TNM system is based on 3 key pieces of information:
  • T describes how far the main (primary) tumor has grown through the bladder wall and whether it has grown into nearby tissues.
  • N indicates any cancer spread to lymph nodes near the bladder. Lymph nodes are bean-sized collections of immune system cells, to which cancers often spread first.
  • M indicates whether or not the cancer has spread (metastasized) to distant sites, such as other organs or lymph nodes that are not near the colon or rectum.
Numbers or letters appear after T, N, and M to provide more details about each of these factors. Higher numbers mean the cancer is more advanced.

AJCC Stage
Stage grouping​
Stage description*
0
Tis
N0
M0		The cancer is in its earliest stage. This stage is also known as carcinoma in situ or intramucosal carcinoma (Tis). It has not grown beyond the inner layer (mucosa) of the colon or rectum.
IT1 or T2
N0
M0		The cancer has grown through the muscularis mucosa into the submucosa (T1), and it may also have grown into the muscularis propria (T2). It has not spread to nearby lymph nodes (N0) or to distant sites (M0).
IIAT3
N0
M0		The cancer has grown into the outermost layers of the colon or rectum but has not gone through them (T3). It has not reached nearby organs. It has not spread to nearby lymph nodes (N0) or to distant sites (M0).
IIBT4a
N0
M0		The cancer has grown through the wall of the colon or rectum but has not grown into other nearby tissues or organs (T4a). It has not yet spread to nearby lymph nodes (N0) or to distant sites (M0).
IICT4b
N0
M0		The cancer has grown through the wall of the colon or rectum and is attached to or has grown into other nearby tissues or organs (T4b). It has not yet spread to nearby lymph nodes (N0) or to distant sites (M0).

​IIIA

T1 or T2
N1/N1c
M0		The cancer has grown through the mucosa into the submucosa (T1), and it may also have grown into the muscularis propria (T2). It has spread to 1 to 3 nearby lymph nodes (N1) or into areas of fat near the lymph nodes but not the nodes themselves (N1c). It has not spread to distant sites (M0).
​OR​
​T1
N2a
M0		The cancer has grown through the mucosa into the submucosa (T1). It has spread to 4 to 6 nearby lymph nodes (N2a). It has not spread to distant sites (M0).

IIIB

T3 or T4a
N1/N1c
M0		The cancer has grown into the outermost layers of the colon or rectum (T3) or through the visceral peritoneum (T4a) but has not reached nearby organs. It has spread to 1 to 3 nearby lymph nodes (N1a or N1b) or into areas of fat near the lymph nodes but not the nodes themselves (N1c). It has not spread to distant sites (M0).
​OR​
​T2 or T3
N2a
M0		The cancer has grown into the muscularis propria (T2) or into the outermost layers of the colon or rectum (T3). It has spread to 4 to 6 nearby lymph nodes (N2a). It has not spread to distant sites (M0).
​OR​
​T1 or T2
N2b
M0		The cancer has grown through the mucosa into the submucosa (T1), and it might also have grown into the muscularis propria (T2). It has spread to 7 or more nearby lymph nodes (N2b). It has not spread to distant sites (M0).

IIIC

T4a
N2a
M0		The cancer has grown through the wall of the colon or rectum (including the visceral peritoneum) but has not​ reached nearby organs (T4a). It has spread to 4 to 6 nearby lymph nodes (N2a). It has not spread to distant sites (M0).
​OR​
​T3 or T4a
N2b
M0		The cancer has grown into the outermost layers of the colon or rectum (T3) or through the visceral peritoneum (T4a) but has not reached nearby organs. It has spread to 7 or more nearby lymph nodes (N2b). It has not spread to distant sites (M0).
​OR​
​T4b
N1 or N2
M0		The cancer has grown through the wall of the colon or rectum and is attached to or has grown into other nearby tissues or organs (T4b). It has spread to at least one nearby lymph node or into areas of fat near the lymph nodes (N1 or N2). It has not spread to distant sites (M0).
IVAAny T
Any N
M1a		The cancer may or may not have grown through the wall of the colon or rectum (Any T). It might or might not have spread to nearby lymph nodes. (Any N). It has spread to 1 distant organ (such as the liver or lung) or distant set of lymph nodes, but not to distant parts of the peritoneum (the lining of the abdominal cavity) (M1a).
IVBAny T
Any N
M1b		The cancer might or might not have grown through the wall of the colon or rectum (Any T). It might or might not have spread to nearby lymph nodes (Any N). It has spread to more than 1 distant organ (such as the liver or lung) or distant set of lymph nodes, but not to distant parts of the peritoneum (the lining of the abdominal cavity) (M1b).
IVC
Any T
Any N
M1c
The cancer might or might not have grown through the wall of the colon or rectum (Any T). It might or might not have spread to nearby lymph nodes (Any N). It has spread to distant parts of the peritoneum (the lining of the abdominal cavity), and may or may not have spread to distant organs or lymph nodes (M1c).​


* The following additional categories are not listed in the table above:

  • TX: Main tumor cannot be assessed due to lack of information.

  • T0: No evidence of a primary tumor.

  • NX: Regional lymph nodes cannot be assessed due to lack of information.​

​American Cancer Society (ACS​). Chapter 20-Colon and Rectum. [ACS Web site].​ Revised: 06/29/2020. Available at: https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/staged.html. Accessed January 26, 2023.

References

American Association of Neurological Surgeons (AANS). Neurosurgical conditions and treatments: Spasticity. Available at: https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed on January 26, 2023.


American Cancer Society (ACS​). Chapter 20-Colon and Rectum. [ACS Web site].​ Revised: 06/29/2020. Available at: https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/staged.html. Accessed January 26, 2023.


American Cancer Society. Chemotherapy for liver cancer. [ACS Web site]. Available at: https://www.cancer.org/cancer/liver-cancer/treating/chemotherapy.html. Accessed on January 26, 2023​.


Ammori JB, Kemeny NE, Fong Y, et al. Conversion to complete resection and/or ablation using hepatic artery infusional chemotherapy in patients with unresectable liver metastases from colorectal cancer: a decade of experience at a single institution. Ann Surg Oncol. 2013;20(9):2901-2907.

Atli A, Theodore BR, Turk DC, et al. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Med. 2010;11(7):1010-1016.

Borrini L, Bensmail D, Thiebaut JB, et al. Occurrence of adverse events in long-term intrathecal baclofen infusion: a 1-year follow-up study of 158 adults. Arch Phys Med Rehabil. 2014;95(6):1032-1038.​


Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Infusion pumps (280.14).12/17/2004 . [CMS website]. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=223&ncdver=2&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=infusion+pumps&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA==&. Accessed January 26, 2023.

Cohen AD, Kemeny NE. An update on hepatic arterial infusion chemotherapy for colorectal cancer. The Oncologist. 2003;8:553-566.

Dan B, Motta F, Vles JS, et al. Consensus on the appropriate use of intrathecal baclofen (ITB) therapy in paediatric spasticity. Eur J Paediatr Neurol. Jan 2010;14(1):19-28

Duarte RV, Raphael JH, Sparkes E, et al. Long-term intrathecal drug administration for chronic nonmalignant pain. J Neurosurg Anesthesiol. 2012;24(1):63-70.

Falco FJ, Patel VB, Hayek SM, et al. Intrathecal infusion systems for long-term management of chronic noncancer pain: an update of assessment of evidence. Pain Physician. 2013;16(2 Suppl):SE185-216.

Farid R. Problem-solving in patients with targeted drug delivery systems. Mo Med. 2017; 114(1): 52–56.

Ghosh D, Mainali G, Khera J, et al. Complications of intrathecal baclofen pumps in children: experience from a tertiary care center. Pediatr Neurosurg. 2013;49:138-144.

Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American College of Chest Physicians task force. Chest. 2006;129(1):174-181.

Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. Oct 2012;13(10):1304-1313.

Hassenbusch SJ, Portenoy RK, Cousins M, et al. Polyanalgesic Consensus Conference 2003: an update on the management of pain by intraspinal drug delivery -- report of an expert panel. J Pain Symptom Manage. 2004;27(6):540-63.

Hayek S; Neuromodulation Special Interest Group of the American Society of Regional Anesthesia and Pain Medicine. Intrathecal dosing and medication selection. Available at: https://www.asra.com/docs/default-source/asra-family-documents/sig-documents/neuromodulation/intrathecal_dosing_and_medication_selection_pope_edit.pdf?sfvrsn=3256de42_2. Accessed on January 26, 2023.

Hoebers FJ, Pluim D, Verheij M, et al. Prediction of treatment outcome by cisplatin-DNA adduct formation in patients with stage III/IV head and neck squamous cell carcinoma, treated by concurrent cisplatin-radiation (RADPLAT). Int J Cancer. Aug 15 2006;119(4):750-756.

Jarnagin WR, Schwartz LH, Gultekin DH, et al. Regional chemotherapy for unresectable primary liver cancer: results of a phase II clinical trial and assessment of DCE-MRI as a biomarker of survival. Ann Oncol. 2009;20(9):1589-1595.

Liu C, Cui Q, Guo J, et al. Intra-Arterial Intervention Chemotherapy for Sarcoma and Cancerous Ulcer Via an Implanted Pump. Pathol Oncol Res. January 21, 2014.

Malheiro L, Gomes A, Barbosa P, et al. Infectious complications of intrathecal drug administration systems for spasticity and chronic pain: 145 patients from a tertiary care center. Neuromodulation. Jul 2015;18(5):421-427.

Manchikanti L, Staats PS, Singh V, et al. Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain. Pain Phys. 2003;6(1):3-81.

Margetis K, Korfias S, Boutos N, et al. Intrathecal baclofen therapy for the symptomatic treatment of hereditary spastic paraplegia. Clin Neurol Neurosurg. 2014;123:142-145.

Markman M, Olawaiye AB. Intraperitoneal chemotherapy for treatment of ovarian cancer. 09/27/2021. Up to Date. [UpToDate Web site].  Available at: https://www.uptodate.com/contents/intraperitoneal-chemotherapy-for-treatment-of-ovarian-cancer?search=ntraperitoneal chemotherapy for treatment of ovarian cancer&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 [via subscription only]. Accessed January 26, 2023.

Matharu G, Tucker O, Alderson D. Systematic review of intraperitoneal chemotherapy for gastric cancer. Br J Surg. 2011;98(9):1225-1235.

Mayfield Clinic Brain & Spine. Pain pump (intrathecal drug pump). 12/2018. Available at: https://mayfieldclinic.com/pe-pump.htm. Accessed on January 26, 2023.

McGivern JG. Ziconotide: a review of its pharmacology and use in the treatment of pain. Neuropsychiatr Dis Treat. 2007; 3(1): 69–85.

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.

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.

Morton RE, Gray N, Vloeberghs M. Controlled study of the effects of continuous intrathecal baclofen infusion in non-ambulant children with cerebral palsy. Dev Med Child Neurol. 2011;53(8):736-741.

Motta F, Antonello CE, Stignani C. Intrathecal baclofen and motor function in cerebral palsy. Dev Med Child Neurol. 2011;53(5):443-448.

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):301-306.

Myers J, Chan V, Jarvis V, et al. Intraspinal techniques for pain management in cancer patients: a systematic review. Support Care Cancer. 2010;18(2):137-149.

National Comprehensive Cancer Network (NCCN). NCCN Clinical practice guidelines in oncology: Adult Cancer Pain. V2.2022. [subscription required]. Available at:​http://www.nccn.org/professionals/physician_gls/pdf/pain.pdf. Accessed January 26, 2023.


National Institute for Health and Care Excellence (NICE). Spasticity in under 19s: management [CG145]. 11/29/2016. Available at: http://guidance.nice.org.uk/CG145. Accessed January 26, 2023.


National Library of Medicine (NLM) of the National Institutes of Health (NIH). Label: Mitigo – morphine sulfate injection. 06/23/2022. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=728f3d83-9a63-0c1f-e053-2a91aa0ac7db. Accessed on January 26, 2023.


Novitas Solutions, Inc. Local Coverage Determination (LCD): Implantable Infusion Pump (L35112). Original: 10/01/2015. Revised 11/14/2019. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=35112&ver=59&bc=0. Accessed January 26, 2023.

Novitas Solutions, Inc. Local Coverage Article: Compounded Drugs Used in an Implantable Infusion Pump (A54100). Original: 01/01/2016. Revised: 11/21/2019. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=54100&ver=37&bc=0. Accessed January 26, 2023.


Novitas Solutions, Inc. Local Coverage Article: Implantable Infusion Pump (A56778). Original: 08/08/2019. Revised: 11/14/2019. Available at:​ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=54100&ver=37&bc=0. Accessed January 26, 2023.​​


Patel VB, Manchikanti L, Singh V, et al. Systematic review of intrathecal infusion systems for long-term management of chronic non-cancer pain. Pain Physician. 2009;12(2):345-360.

Peck D, Diwan S. Programmable versus fixed-rate pumps for intrathecal drug delivery. In: Deer TR, Siwan S, Buvanendran A. Intrathecal drug delivery for pain and spasticity.Volume 2. Philadelphia, PA: Elsevier Saunders; 2012: 84-89.

Pin TW, McCartney L, Lewis J, et al. Use of intrathecal baclofen therapy in ambulant children and adolescents with spasticity and dystonia of cerebral origin: a systematic review. Dev Med Child Neurol. Oct 2011;53(10):885-895. PMID 21635230.

Pope JE, Deer TR. Guide to Implantable Devices for Intrathecal Therapy. 09/25/2013. [Practical Pain Management Web site]. Available at: https://www.practicalpainmanagement.com/treatments/interventional/pumps/guide-implantable-devices-intrathecal-therapy. Accessed on January 26, 2023.

PRNewswire. Piramal critical care announces the U.S. launch of Mitigo™. 03/11/2019. Available at: https://www.prnewswire.com/news-releases/piramal-critical-care-announces-the-us-launch-of-mitigo-300809900.html#:~:text=BETHLEHEM, Pennsylvania, March 11, 2019 /PRNewswire/ -- Piramal,and 25 mg/mL concentrations in the U.S. market. Accessed on January 26, 2023.

Smith GW, Bukowski RM, Hewlett JS, et al. Hepatic artery infusion of 5-fluorouracil and mitomycin C in cholangiocarcinoma and gallbladder carcinoma. Cancer. 1984;54(8):1513-1516.

Stokic DS, Yablon SA. Effect of concentration and mode of intrathecal baclofen administration on soleus H-reflex in patients with muscle hypertonia. Clin Neurophysiol. 2012;123(11):2200-2204.

US Food and Drug Administration (FDA). Infumorph drug label. [FDA Web site]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf. Accessed on January 26, 2023.


US Food and Drug Administration (FDA). Medical Devices. What Is an Infusion Pump? 12/13/2017. Available at:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202495.htm. Accessed January 26, 2023.​


US Food and Drug Administration (FDA). Preservative-free Duramorph (morphine sulfate injection, USP). [FDA Web site]. ​Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf. Accessed on January 26, 2023.


US Food and Drug Administration (FDA). Prialt drug label (ziconotide intrathecal infusion). [FDA Web site]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021060s003lbl.pdf. Accessed on January 26, 2023​.

US Food and Drug Administration (FDA). FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices. [FDA Web site]. 11/14/2018. Available at: https://www.fda.gov/news-events/press-announcements/fda-alerts-doctors-patients-about-risk-complications-when-certain-implanted-pumps-are-used-deliver. Accessed on January 26, 2023.

Veizi IE, Hayek SM, Narouze S, et al. Combination of intrathecal opioids with bupivacaine attenuates opioid dose escalation in chronic noncancer pain patients. Pain Med. 2011;12(10):1481-1489.

Vles GF, Soudant DL, Hoving MA, et al. Long-term follow-up on continuous intrathecal baclofen therapy in non-ambulant children with intractable spastic cerebral palsy. Eur J Paediatr Neurol. Nov 2013;17(6):639-644.

Wilkes D. Programmable intrathecal pumps for the management of chronic pain: Recommendations for improved efficiency. J Pain Res. 2014; 7: 571–577.

Coding

CPT Procedure Code Number(s)
36260, 36261, 36262, 36563, 36576, 36578, 36583, 36590, 61215, 62350, 62351, 62355, 62360, 62361, 62362, 62365, 62367, 62368, 62369, 62370, 95990, 95991, 96522, 96523
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)

​MEDICALLY NECESSARY


A4220 Refill kit for implantable infusion pump

A4221 Supplies for maintenance of non-insulin drug infusion catheter, per week (list drugs separately)

C1755 Catheter, intraspinal

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.)

E0785 Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement

E0786 Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)

IMPLANTABLE INFUSION PUMPS ARE MEDICALLY NECESSARY WHEN USED IN COMBINATION WITH THE FOLLOWING DRUG FOR SEVERE SPASTICITY AND CHRONIC PAIN MANAGEMENT
(THIS LIST IS NOT ALL-INCLUSIVE):

J0475 Injection, baclofen, 10 mg

J0476 Injection, baclofen, 50 mcg for intrathecal trial

J2270 Injection, morphine sulfate, up to 10 mg

J2274 Injection, morphine sulfate, preservative free for epidural or intrathecal use, 10 mg

J2278 Injection, ziconotide, 1 mcg

S0093 Injection, morphine sulfate, 500 mg (loading dose for infusion pump)

NOT MEDICALLY NECESSARY


IMPLANTABLE INFUSION PUMPS ARE NOT MEDICALLY NECESSARY WHEN USED IN COMBINATION WITH THE FOLLOWING DRUG FOR PAIN MANAGEMENT:

J0735 Injection, clonidine HCl, 1 mg

J1170 Injection, hydromorphone, up to 4 mg

J3010 Injection, fentanyl citrate, 0.1 mg

S0020 Injection, bupivicaine HCl, 30 ml

S0092 Injection, hydromorphone HCl, 250 mg (loading dose for infusion pump)

S0093 Injection, morphine sulfate, 500 mg (loading dose for infusion pump)
Revenue Code Number(s)
N/A



Coding and Billing Requirements

Policy History

4/10/2023
4/10/2023
11.15.03
Medical Policy Bulletin
Commercial
No