Notification

Implantable Infusion Pumps


Notification Issue Date: 11/19/2019

This version of the policy will become effective 02/17/2020.

This policy has been updated in consideration of a Safety Communication issued by the US Food and Drug Administration (FDA):

  • Not Medically Necessary criteria established for the use of non-approved drugs, drug mixtures, and compounded drugs for intrathecal administration via implanted pumps
  • Description section updated to communicate most recent technical information regarding implantable infusion pumps and indications for use

The following codes were added as Not Medically Necessary for intrathecal pumps usage:
  • 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

Due to expansion of policy scope beyond pump implantation, now including information about appropriate drug use, the title of this policy was changed:

FROM: Insertion of Implantable Infusion Pumps
TO: Implantable Infusion Pumps


Medical Policy Bulletin


Title:Implantable Infusion Pumps

Policy #:11.15.03k



The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, 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. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. 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.


Refer to the following News Article: Waiver of certain requirements during COVID-19 outbreak related to Durable Medical Equipment (DME), prosthetics, orthotics, and supplies


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 any of the following chemotherapy regimens:
  • Intra-arterial infusion of 5-fluorodeoxyuridine (5-FUdR) for the treatment of liver cancer for individuals with primary hepatocellular carcinoma
  • Intravenous infusion for the treatment of Duke's Class D colorectal cancer, in which metastases are limited to the liver, and either the disease is unresectable or 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 by both of the following criteria:
  • An 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, an 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 by one of the following criteria:
  • An individual's history must indicate that he/she did not respond adequately 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.

Determinations may be made on the medical necessity of other uses of implantable infusion pumps if 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 insertion of implantable infusion pumps is contraindicated for individuals with one or more of the following:
  • 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)

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.

Professional services for the care and maintenance of implantable infusion pumps are eligible for reimbursement consideration.

Refill kits and supplies that are reported by a professional provider using Healthcare Common Procedural Coding System (HCPCS) codes A4220 and A4221 are considered integral to the services of the professional provider when reported in conjunction with CPT codes 95990, 95991, 96522, 96523. Therefore, refill kits and supplies are not eligible for separate reimbursement consideration for professional providers.

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.

NOT MEDICALLY NECESSARY

The use of any medicine not identified in the implanted pump labeling for intrathecal infusion to treat or manage pain (e.g. hydromorphone, bupivacaine, fentanyl, clonidine) is 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 mixture of two or more different kinds of medicines for administration through the implanted pump for intrathecal infusion to treat or manage pain is 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 compounded medicine in the implanted pump for intrathecal infusion to treat or manage pain is 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.
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: "Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication".)


References


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American Cancer Society. Chemotherapy for liver cancer. [ACS Web site]. Available at: https://www.cancer.org/cancer/liver-cancer/treating/chemotherapy.html. Accessed on August 20, 2019.

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). 280.14: Infusion pumps. [CMS Web site]. 12/17/04. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=223&ncdver=2&DocID=280.14&kq=true&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed April 6, 2018.

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.
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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/page/223/intrathecal-dosing-and-medication-selection. Accessed on August 02, 2019.

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. Jan 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. 07/13/17. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed May 22, 2018.

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 August 02, 2019.

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. Version 1.2018. [subscription required]. http://www.nccn.org/professionals/physician_gls/pdf/pain.pdf. Accessed April 6, 2018.

National Institute for Health and Care Excellence (NICE). Spasticity in under 19s: management [CG145]. 2016 November; http://guidance.nice.org.uk/CG145. Accessed April 6, 2018.

National Library of Medicine (NLM) of the National Institutes of Health (NIH). Label: Mitigo – morphine sulfate injection. 07/23/2019. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=728f3d83-9a63-0c1f-e053-2a91aa0ac7db. Accessed on August 05, 2019.

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 August 08, 2019.

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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.

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US Food and Drug Administration (FDA). Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Due to Failure of Priming Bolus – Update Related to May 2013 Recall. [FDA Web site]. 08/03/2018. Available at: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-synchromed-ii-and-synchromed-el-implantable-drug-infusion-pumps-due-failure. Accessed on August 05, 2019.

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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.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

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


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



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)



MEDICALLY NECESSARY

THE IMPLANTABLE INFUSION PUMPS DESCRIBED IN THIS POLICY ARE MEDICALLY NECESSARY WHEN USED IN COMBINATION WITH THE FOLLOWING DRUG CODES 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

THE IMPLANTABLE INFUSION PUMPS DESCRIBED IN THIS POLICY ARE NOT MEDICALLY NECESSARY WHEN USED IN COMBINATION WITH THE FOLLOWING DRUG CODES 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


NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT

THE FOLLOWING SERVICES ARE INTEGRAL TO REFILLING AND MAINTENANCE OF IMPLANTABLE PUMP SERVICES (95990, 95991, 96522, 96523):

A4220 Refill kit for implantable infusion pump

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




Revenue Code Number(s)

N/A



Coding and Billing Requirements


Cross References


Policy History

11.15.03k:

02/17/2020This version of the policy will become effective 02/17/2020.

This policy has been updated in consideration of a Safety Communication issued by the US Food and Drug Administration (FDA):
  • Not Medically Necessary criteria established for the use of non-approved drugs, drug mixtures, and compounded drugs for intrathecal administration via implanted pumps
  • Description section updated to communicate most recent technical information regarding implantable infusion pumps and indications for use
The following codes were added as Not Medically Necessary for intrathecal pumps usage:
  • 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

Due to expansion of policy scope beyond pump implantation, now including information about appropriate drug use, the title of this policy was changed:

FROM: Insertion of Implantable Infusion Pumps
TO: Implantable Infusion Pumps

11.15.03j:
07/30//2018This version of the policy will become effective 07/30/2018.

The following criteria have been deleted from this policy for the insertion of implantable infusion pumps:
  • Primary epithelial ovarian cancer (intraperitoneal infusion as a component of chemotherapy)

The following HCPCS codes have been added to this policy:
  • C1891 Infusion pump, nonprogrammable, permanent (implantable)
  • C2626 Infusion pump, nonprogrammable, temporary (implantable)
  • C8957 Intravenous infusion for therapy/diagnosis; initiation of prolonged infusion (more than 8 hours), requiring use of portable or implantable pump - new codes


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 02/17/2020
Version Issued Date: 02/17/2020
Version Reissued Date: N/A



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