Notification

Insertion of Implantable Infusion Pumps


Notification Issue Date: 06/27/2018

This 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



Medical Policy Bulletin


Title:Insertion of Implantable Infusion Pumps

Policy #:11.15.03j

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


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 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.
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

An implantable infusion pump is a drug delivery system that provides for the continuous infusion of an agent (e.g., morphine or a chemotherapy drug) at a constant and precise flow rate. 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)

References


2004 Clinical Practice Recommendations. Diabetes Care. 2013; 36:suppl.1; http://care.diabetesjournals.org/content/36/Supplement_1/S1.full.pdf+html. Accessed April 6, 2018.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.





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)

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

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)



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

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: 07/30/2018
Version Issued Date: 07/30/2018
Version Reissued Date: N/A

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.