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Implantable Infusion Pumps
MA05.053l


Policy

​MEDICALLY NECESSARY

Implantable infusion pumps are considered medically necessary and, therefore, covered when used for one or more of the following criteria:

CHEMOTHERAPY FOR CANCER 
​When used for intra-arterial infusion of 5-FUdR for the tr​​​eatment of liver cancer for individuals with primary hepatocellular carcinoma or Duke's Class D colorectal cancer, in whom the metastases are limited to the liver, 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

​When used to administer antispasmodic drugs intrathecally (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 adequately the spasticity or produce intolerable side effects, as indicated by at least a 6-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

When used to administer opioid drugs (e.g., morphine) intrathecally or epidurally for treatment of severe chronic intractable pain of a malignant or nonmalignant origin in individuals who have a life expectancy of at least 3 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 and 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 when all of the following criteria are met:
  • The drug is considered medically necessary for the treatment of the individual
  • It is medically necessary that the drug 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 US Food and Drug Administration–approved labeling.​​

CONTRAINDICATIONS

Implantable infusion pumps are 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)​
NOT COVERED​

 Implantable infusion pumps for the treatment of thromboembolic disease or diabetes are not covered by the Company because this service is not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

NOT MEDICALLY NECESSARY

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 be maintained on file to 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.

 

STANDARD WRITTEN ORDER REQUIREMENTS

Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

 

PROOF OF DELIVERY REQUIREMENTS

Medical record documentation must include a contemporaneously prepared delivery confirmation or member's receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

 

CONSUMABLE SUPPLIES (WHEN APPLICABLE)

The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual's medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply.

 

For specified DME items, documentation of a face-to-face encounter between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual's clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.

 

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments​.

Guidelines

This policy is consistent with Medicare’s coverage determination for implantable infusion pumps. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, implantable infusion pumps is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as not covered or not medically necessary are not eligible for coverage or reimbursement by the Company.

Subject to the applicable Evidence of Coverage, disposable drug delivery systems is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered not covered.

Description

IMPLANTABLE INFUSION PUMPS

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 are able to 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)
FDA ADVISORY

In 2018, the US Food and Drug Administration (FDA) released a communication regarding the risk of using nonapproved 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 nonapproved 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 nonapproved 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 (e.g., hydromorphone, bupivacaine, fentanyl, clonidine)

ANY mixture of two or more different kinds of medicines

Any compounded medicine (e.g., 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

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

​

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. Oncologist. 2003;8:553-566.

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

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 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.

Mayfield Clinic Brain & Spine. Pain pump (intrathecal drug pump). 12/2018. Available at: https://mayfieldclinic.com/pe-pump.htm. 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 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. 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. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=54100&ver=37&bc=0. Accessed January 26, 2023.
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.

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 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 January 26, 2023.

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 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 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 January 26, 2023.


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)

​MEDICALLY NECESSARY


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 drug 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 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

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
MA05.053
Medical Policy Bulletin
Medicare Advantage
No
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.