Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Implantable and External Infusion Pumps
Policy #:MA05.053g

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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


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

IMPLANTABLE INFUSION PUMPS

MEDICALLY NECESSARY
Implantable infusion pumps are considered medically necessary and, therefore, covered for ANY of the following indications:
  • When used for intra-arterial infusion of 5-FUdR for the treatment 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 where:
    • The disease is unresectable OR
    • The individual refuses surgical excision of the tumor.
  • When used to administer anti-spasmodic drugs intrathecally (e.g., baclofen) to treat chronic intractable spasticity in individuals who have proven unresponsive to less invasive medical therapy as determined by the following criteria:
    • At least a 6-week trial: the individual cannot be maintained on noninvasive methods of spasm control, such as oral anti-spasmodic drugs, either because these methods fail to control adequately the spasticity or produce intolerable side effects, and, prior to pump implantation, the individual must have responded favorably to a trial intrathecal dose of the anti-spasmodic drug.
  • When used to administer opioid drugs (e.g., morphine) intrathecally or epidurally for treatment of severe chronic intractable pain of 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 by the following criteria:
    • The individual's history must indicate that he or she would not respond adequately to noninvasive methods of pain control, such as systemic opioids (including attempts to eliminate physical and behavioral abnormalities that may cause an exaggerated reaction to pain); additionally, 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.

Determinations may be made on coverage of other uses of implantable infusion pumps if 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; and,
  • The Food and Drug Administration (FDA)--approved labeling for the pump specifies that the drug being administered, and the purpose for which it is administered, is an indicated use for the pump.

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, it is not eligible for reimbursement consideration.

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.

EXTERNAL INFUSION PUMPS

MEDICALLY NECESSARY
An external infusion pump (E0779, E0780, E0781, and E0791) is considered medically necessary and, therefore, covered for any of the following indications:
  • Administration of deferoxamine for the treatment of chronic iron overload
  • Administration of chemotherapy for the treatment of primary hepatocellular carcinoma or colorectal cancer where the disease is unresectable or where the individual refuses surgical excision of the tumor. Anticancer chemotherapy drugs used in these conditions are not required to meet the following criteria:
    • Criteria sets 1 or 2 (see below); for the administration of other drugs on an external infusion pump
    • Administration of the anticancer chemotherapy drugs, cladribine, fluorouracil, cytarabine, bleomycin, floxuridine, doxorubicin (non-liposomal), vincristine (non-liposomal) or vinblastine by continuous infusion for at least 8 hours when the regimen is proven or generally accepted to have significant advantages over intermittent administration regimens
  • Administration of morphine when used in the treatment of intractable pain caused by cancer
  • Administration of continuous subcutaneous insulin for the treatment of diabetes mellitus when one of the following criteria listed below are met:
    • C-peptide testing that meets the following criteria:
      • C-peptide level is less than or equal to 110 percent of the lower limit of normal of the laboratory's measurement method; OR
      • For individuals with renal insufficiency and a creatinine clearance (actual or calculated from age, weight, and serum creatinine) less than or equal to 50 ml/minute, a fasting C-peptide level is less than or equal to 200 percent of the lower limit of normal of the laboratory’s measurement method; AND
      • A fasting blood sugar obtained at the same time as the C-peptide level is less than or equal to 225 mg/dL.
    • Beta cell autoantibody test is positive.
    • The individual has completed a comprehensive diabetes education program, has been on a program of multiple daily injections of insulin (i.e., at least 3 injections per day) with frequent self-adjustments of insulin dose for at least 6 months prior to initiation of the insulin pump, and has documented frequency of glucose self-testing an average of at least 4 times per day during the 2 months prior to initiation of the insulin pump, and meets one or more of the following criteria while on the multiple injection regimen:
      • Glycosylated hemoglobin level (HbA1C) greater than 7 percent
      • History of recurring hypoglycemia
      • Wide fluctuations in blood glucose before mealtime
      • Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL
      • History of severe glycemic excursions
    • The individual has been on an external insulin infusion pump prior to enrollment in a Medicare plan and has documented frequency of glucose self-testing an average of at least 4 times per day during the month prior to Medicare enrollment.

Continued coverage of an external insulin pump and supplies requires that the individual be seen and evaluated by the treating professional provider at least every 3 months. In addition, the external insulin infusion pump must be ordered and follow-up care rendered by a professional provider who manages multiple individuals on continuous subcutaneous insulin infusion therapy and who works closely with a team including nurses, diabetic educators, and dieticians who are knowledgeable in the use of continuous subcutaneous insulin infusion therapy.

When subcutaneous insulin is administered on an external infusion pump, an ambulatory infusion pump (E0784) is used. The use of subcutaneous insulin on any other pump will be considered not medically necessary and, therefore, not covered.
  • Administration of other specified drugs is covered when the criteria in EITHER Criteria Set 1 OR Criteria Set 2 are met AND an appropriate indication is met:
    • Criteria Set 1:
      • Parenteral administration of the drug in the home is considered medically necessary.
      • An infusion pump is necessary to safely administer the drug.
      • The drug is administered by a prolonged infusion of at least 8 hours because of proven improved clinical efficacy.
      • The therapeutic regimen is proven or generally accepted to have significant advantages over intermittent bolus administration regimens or infusions lasting less than 8 hours.
      OR
    • Criteria Set 2:
      • Parenteral administration of the drug in the home is considered medically necessary.
      • An infusion pump is necessary to safely administer the drug.
      • The drug is administered by intermittent infusion (each episode of infusion lasting less than 8 hours), which does not require the individual to return to the professional provider's office prior to the beginning of each infusion.
      • Systemic toxicity or adverse effects are unavoidable without infusing the drug at a strictly controlled rate as indicated in the Physicians Desk Reference, or the U.S. Pharmacopeia Drug Information.
AND WHEN ANY OF THE FOLLOWING INDICATIONS ARE MET:
    • The administration of the anticancer chemotherapy drugs cladribine, fluorouracil, cytarabine, bleomycin, floxuridine, doxorubicin (non-liposomal), vincristine (non-liposomal) or vinblastine by continuous infusion over at least 8 hours when the regimen is proven or generally accepted to have significant advantages over intermittent administration regimens.
    • The administration of narcotic analgesics (except meperidine) in place of morphine for an individual with intractable pain caused by cancer that has not responded to an adequate oral/transdermal therapeutic regimen and/or cannot tolerate oral/transdermal narcotic analgesics.
    • The administration of the following antifungal or antiviral drugs: acyclovir, foscarnet, amphotericin B, and ganciclovir.
    • The administration of parenteral inotropic therapy using the drugs; dobutamine (J1250), milrinone (J2260) or dopamine (J1265) for individuals with American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Stage D heart failure (HF) or New York Heart Association (NYHA) Class IV HF, and the individual meets all of the following criteria:
      • Remains symptomatic despite optimal guideline directed medical therapy (GDMT) as defined by the following by ACCF/AHA guideline. Recommended therapies (primarily Class I recommendations), which include the use of diuretics, ACE inhibitors or ARB antagonists, beta-blockers, aldosterone antagonists, hydralazine & isosorbide dinitrate, and statins, as appropriate.
      • As “Bridge” therapy for individuals eligible for and awaiting mechanical circulatory support (MCS)/cardiac transplantation, or as palliative care for individuals not eligible for either MCS/cardiac transplantation
      • Prescribed following an evaluation by a cardiologist or professional provider or cardiologist with training in the management of advanced heart failure
      • There has been a documented improvement in the individuals symptoms of heart failure while on the selected inotropic drug at the time of discharge from an inpatient or skilled nursing care facility
      • An evaluation will be performed every three months by the prescribing professional provider or a heart failure team with oversight by a cardiologist with training in the management of advanced heart failure, which documents the individual's cardiac symptoms and the continuing response and need for therapy.
    • The administration of epoprostenol (J1325) or treprostinil (J3285) for individuals with pulmonary hypertension. Please refer to the specific policy, titled Treatment of Pulmonary Artery Hypertension with Intravenous, Subcutaneous, and Inhaled Pharmacologic Agents Intended for Home Use.
      • Epoprostenol/treprostinil is administered using an ambulatory infusion pump (K0455).
    • The administration of Gallium nitrate (J1457) for the treatment of symptomatic cancer-related hypercalcemia. In general, individuals with serum calcium (corrected for albumin) less than 12 mg/dl would not be expected to be symptomatic.
      • The recommended usage for gallium nitrate is daily for five consecutive days. The use of gallium nitrate for more that five days is considered not medically necessary, and therefore not covered.
      • More than one course of treatment for the same episode of hypercalcemia is considered not medically necessary and, therefore, not covered.
    • The administration of Ziconotide (J2278) for the management of severe chronic pain in individuals for whom intrathecal (IT or epidural) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.
    • The administration of subcutaneous immune globulin (J1559, J1561, J1569, J1575, J1555) is covered only if BOTH of the following criteria are met:
      • The subcutaneous immune globulin preparation is a pooled plasma derivative that is approved for the treatment of primary immune deficiency disease.
      • The individual has a diagnosis of primary immune deficiency disease.

Coverage of subcutaneous immune globulin on an external infusion pump applies only to those products that are specifically labeled as subcutaneous administration products. (Please refer to the specific policy on Immune Globulin: Intravenous (IVIG), Subcutaneous (SCIG).

Only an ambulatory external infusion pump (E0779) is considered medically necessary and, therefore, covered for the administration of subcutaneous immune globulin. The use of any other pump for subcutaneous immune globulin will be considered not medically necessary and, therefore, not covered.
    • The administration of levodopa-carbidopa enteral suspension (Duopa) (J7340) on an external infusion pump for the treatment of motor fluctuations in individuals with Parkinson’s disease (PD), who meet ALL of the following criteria:
      • The individual has been evaluated by a neurologist, who prescribes and manages treatment with the drug.
      • Idiopathic PD based on the presence of bradykinesia and at least one other cardinal PD feature (e.g., tremor, rigidity, postural instability).
      • L-dopa responsive with clearly defined “On” periods.
      • Persistent motor complications with disabling “Off” periods for a minimum of 3 hours/day, despite medical therapy with levodopa-carbidopa, and at least one other class of anti-PD therapy (i.e., catechol-O-methyltransferase (COMT) inhibitor or Monoamine oxidase inhibitors (MAO-B) inhibitor).
    • The administration of blinatumomab (Blincyto) (J9039) on an external infusion pump for the treatment of adult individuals with:
      • Relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), or
      • Minimal residual disease positive (MRD+) B-cell acute lymphoblastic leukemia (B-ALL).
    (Please refer to the specific policy titled Blinatumomab [Blincyto™])

NOT MEDICALLY NECESSARY
If the above criteria are not met, the pump and related accessories and supplies will be considered not medically necessary and, therefore, not covered.

An infusion controller device (E1399) is considered not medically necessary and, therefore, not covered.

NOT COVERED
The administration of Vancomycin on an external infusion pump is not covered by the Company because it is an item/service not covered by Medicare. There is insufficient evidence to support the medical necessity of using an external infusion pump instead of a disposable elastomeric pump or the gravity drip method to administer vancomycin in a safe and appropriate manner.

SUPPLIES

Supplies for the maintenance of a parenteral drug infusion catheter (A4221) are considered medically necessary and, therefore, covered during the period of covered use of an infusion pump.

Supplies used with an external infusion pump (A4222 or K0552) are considered medically necessary and, therefore, covered during the period of covered use of an infusion pump.

An IV pole (E0776) is considered medically necessary and, therefore, covered only when a stationary infusion pump (E0791) is considered medically necessary.

An IV pole (E0776) is considered not eligible for separate reimbursement and, therefore, not covered, if it is submitted on the same date of service as an ambulatory infusion pump (E0779, E0780, E0781, E0784, or K0455).

Disposable drug delivery systems (A9274) (i.e., elastomeric infusion pumps), are not covered by the Company because it is an item not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

FACE-TO-FACE REQUIREMENTS

As a condition for payment, a professional provider must have a face-to-face examination with the individual for whom the item is ordered that meets all of the following requirements:
  • The treating professional provider must have an in-person examination with the individual within the six months prior to the date of the written order prior to delivery.
  • This examination must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.

A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required:
  • For all claims for purchases or initial rentals
  • When there is a change in the prescription for the accessory, supply, drug, etc.
  • If periodic prescription renewal required per medical policy
  • When an item is replaced
  • When there is a change in the supplier
  • When required by state law

In this policy the specified items are:

Code
Narrative
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.)
E0784
External ambulatory infusion pump, insulin
E0786
Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)

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. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete 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 order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
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 DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (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 seven 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 five days before the individual would exhaust their on-hand supply.

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 durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination for implantable and external 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 and external 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 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".)


EXTERNAL INFUSION PUMPS

External infusion pumps are durable medical equipment used to deliver solutions containing parenteral drugs under pressure at a regulated flow rate.
References

American Association of Neurological Surgeons. Neurosurgical conditions and treatments: Spasticity. Available at: https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed on August 20, 2019.

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.

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%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.

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/page/223/intrathecal-dosing-and-medication-selection. 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.

Mayfield Clinic Brain & Spine. Pain pump (intrathecal drug pump). 12/2018. Available at: https://mayfieldclinic.com/pe-pump.htm. Accessed on August 02, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology:Acute Lymphoblastic Leukemia. V1. 2018. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp [via subscription only]. Accessed May 17, 2018.

Noridian Healthcare Solutions, LLC. Local Coverage Article for External Infusion Pumps - Policy Article - Effective 07/11/2017 (A52507). Available at: https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD. Accessed April 06, 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.

Noridian Healthcare Solutons, LLC. Local Coverage Determination (LCD): External Infusion Pumps (L33794). Revised 07/11/2017. Available at: https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD. Accessed April 06, 2018.

Novitas Solutions, Inc. Local Coverage Determination (LCD): Implantable Infusion Pump (L35112 ). Original: 10/01/2015. Revised 01/01/2016. Available at:
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35112&ver=41&name=314*1&UpdatePeriod=741&bc=AQAAEAAAAAAAAA%3d%3d&. Accessed April 6, 2018.

Novitas Solutions, Inc. Local Coverage Article: 01/01/2016. Compounded Drugs Used in an Implantable Infusion Pump (A54100). https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=54100&ver=33&Date=01%2f28%2f2016&DocID=A54100&bc=hAAAAAgAAAAAAA%3d%3d& Accessed April 6, 2018.

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 on August 08, 2019.

PRNewswire. Piramal critical care announces the U.S. launch of Mitigo™. 03/11/2019. Available at: https://www.ptcommunity.com/wire/piramal-critical-care-announces-us-launch-mitigotm. Accessed on August 05, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @FDA. Blinatumomab (Blincyto) approval letter and prescribing information. [FDA Web site]. 03/29/2018. Available at:
https://www.accessdata.fda.gov/scripts/cder/daf/#labelinfo . Accessed May 23, 2018.

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 August 05, 2019.

US Food and Drug Administration (FDA). Medical Devices. What Is an Infusion Pump? Available at:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202495.htm. Accessed April 6, 2018.

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.

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 August 05, 2019.

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 August 05, 2019.

US Food and Drug Administration (FDA). Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication. [FDA Web site]. 11/14/2018. Available at: https://www.fda.gov/medical-devices/safety-communications/use-caution-implanted-pumps-intrathecal-administration-medicines-pain-management-fda-safety. Accessed on July 29, 2019.

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

Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJV, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WHW, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128:1810–1852.



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)

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 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)



THE FOLLOWING CODES ARE USED TO REPRESENT IMPLANTABLE INFUSION PUMPS:

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)


THE FOLLOWING CODES ARE USED TO REPRESENT EXTERNAL INFUSION PUMPS:

E0779 Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater

E0780 Ambulatory infusion pump, mechanical, reusable, for infusion less than 8 hours

E0781 Ambulatory infusion pump, single or multiple channels, electric or battery operated, with administrative equipment, worn by patient

E0784 External ambulatory infusion pump, insulin

E0791 Parenteral infusion pump, stationary, single, or multichannel

K0455 Infusion pump used for uninterrupted parenteral administration of medication, (e.g., epoprostenol or treprostinol)


THE FOLLOWING CODES ARE USED TO REPRESENT SUPPLIES FOR INFUSION PUMPS:

A4220 Refill kit for implantable infusion pump

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

A4222 Infusion supplies for external drug infusion pump, per cassette or bag (list drugs separately)

A4223 Infusion supplies not used with external infusion pump, per cassette or bag (list drugs separately)

A4224 Supplies for maintenance of insulin infusion catheter, per week

A4225 Supplies for external insulin infusion pump, syringe type cartridge, sterile, each

A4602 Replacement battery for external infusion pump owned by patient, lithium, 1.5 volt, each

E0776 IV pole

K0552 Supplies for external non-insulin drug infusion pump, syringe type cartridge, sterile, each

K0601 Replacement battery for external infusion pump owned by patient, silver oxide, 1.5 volt, each

K0602 Replacement battery for external infusion pump owned by patient, silver oxide, 3 volt, each

K0603 Replacement battery for external infusion pump owned by patient, alkaline, 1.5 volt, each

K0604 Replacement battery for external infusion pump owned by patient, lithium, 3.6 volt, each

K0605 Replacement battery for external infusion pump owned by patient, lithium, 4.5 volt, each

S0155 Sterile dilutant for epoprostenol, 50 ml


THE FOLLOWING CODES ARE USED TO REPRESENT DRUGS FOR INFUSION PUMPS:

J0133 Injection, acyclovir, 5 mg

J0285 Injection, amphotericin B, 50 mg

J0287 Injection, amphotericin B lipid complex, 10 mg

J0288 Injection, amphotericin B cholesteryl sulfate complex, 10 mg

J0289 Injection, amphotericin B liposome, 10 mg

J0475 Injection, baclofen, 10 mg

J0476 Injection, baclofen, 50 mcg for intrathecal trial

J0895 Injection, deferoxamine mesylate, 500 mg

J1170 Injection, hydromorphone, up to 4 mg

J1250 Injection, Dobutamine HCl, per 250 mg

J1265 Injection, dopamine HCl, 40 mg

J1325 Injection, epoprostenol, 0.5 mg

J1455 Injection, foscarnet sodium, per 1,000 mg

J1457 Injection, gallium nitrate, 1 mg

J1555 Injection, immune globulin (Cuvitru), 100 mg

J1559 Injection, immune globulin (Hizentra), 100 mg

J1561 Injection, immune globulin, (Gamunex/Gamunex-C/Gammaked), nonlyophilized (e.g., liquid), 500 mg

J1569 Injection, immune globulin, (Gammagard liquid), nonlyophilized, (e.g., liquid), 500 mg

J1570 Injection, ganciclovir sodium, 500 mg


J1575 Injection, immune globulin/hyaluronidase, 100 mg immuneglobulin

J1817 Insulin for administration through DME (i.e., insulin pump) per 50 units

J1960 Injection, levorphanol tartrate, up to 2 mg

J2175 Injection, meperidine HCl, per 100 mg

J2180 Injection, meperidine and promethazine HCl, up to 50 mg

J2260 Injection, milrinone lactate, 5 mg

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

J3010 Injection, fentanyl citrate, 0.1 mg

J3285 Injection, treprostinil, 1 mg

J7340 Carbidopa 5 mg/levodopa 20 mg enteral suspension, 100ml

J9000 Injection, doxorubicin HCl, 10 mg

J9039 Injection, blinatumomab, 1 microgram

J9040 Injection, bleomycin sulfate, 15 units

J9065 Injection, cladribine, per 1 mg

J9100 Injection, cytarabine, 100 mg

J9190 Injection, fluorouracil, 500 mg

J9200 Injection, floxuridine, 500 mg

J9360 Injection, vinblastine sulfate, 1 mg

J9370 Vincristine sulfate, 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)


NOT COVERED

A9274 External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories

THE FOLLOWING CODE IS USED TO REPRESENT AN INFUSION CONTROLLER DEVICE:

E1399 Durable medical equipment, miscellaneous

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




Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA05.053g
11/18/2019This version of the policy will become effective 11/18/2019.

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 have been added to the policy as Not Medically Necessary for use with intrathecal infusion pumps:
  • 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


MA05.053f
07/30/2018This version of the policy will become effective 07/30/2018.

The following indication has been added to this policy for the administration of blinatumomab (Blincyto) (J9039) on an external infusion pump:
  • Minimal residual disease positive (MRD+) B-cell acute lymphoblastic leukemia (B-ALL)

The following criteria has been revised regarding the administration of blinatumomab (Blincyto) (J9039):
Changed from: The administration of blinatumomab (Blincyto) (J9039) on an external infusion pump for the treatment of adult individuals with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) that is either:
  • Philadelphia chromosome-negative disease
  • Philadelphia chromosome-positive refractory to tyrosine kinase inhibitor therapy [e.g., dasatinib (Sprycel), nilotinib (Tasigna)].

Changed to: The administration of blinatumomab (Blincyto) (J9039) on an external infusion pump for the treatment of adult individuals with:
  • Relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), or
  • Minimal residual disease positive (MRD+) B-cell acute lymphoblastic leukemia (B-ALL).
(Please refer to the specific policy titled Blinatumomab (Blincyto®)

The following CPT codes have been deleted from this policy:

36260, 36261, 36262, 62350, 62351, 62355, 62360, 62361, 62362, 62365, 62367, 62368, 62369, 62370, 95990, 95991, 96522


The following HCPCS codes have been added to this policy:

C1891 Infusion pump, nonprogrammable, permanent (implantable)

C2626 Infusion pump, nonprogrammable, temporary (implantable)

J1555 Injection, immune globulin (Cuvitru), 100 mg

The following HCPCS code has been deleted from this policy:

J7999 Compounded drug, not otherwise classified



MA05.053e
07/14//2017 The following policy statement has been added to this policy:

Disposable drug delivery systems (A9274) (i.e. elastomeric infusion pumps), are not covered by the Company because it is an item) not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

MA05.053d
06/07/2017This policy has been reissued in accordance with the Company's annual review process.
01/01/2017This version of the policy will become effective 01/01/2017.

The following HCPCS codes have been added to this policy:
  • A4224 Supplies for maintenance of insulin infusion catheter, per week
  • A4225 Supplies for external insulin infusion pump, syringe type cartridge, sterile, each

The following HCPCS code narratives has been revised in this policy:

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

CODE:J7340
    FROM: Carbidopa 5 mg/levodopa 20 mg enteral suspension
    TO: Carbidopa 5 mg/levodopa 20 mg enteral suspension, 100 ml

CODE: K0552
    FROM: Supplies for external drug infusion pump, syringe type cartridge, sterile, each
    TO: Supplies for external non-insulin drug infusion pump, syringe type cartridge, sterile, each

MA05.053c
09/23/2016 This version of the policy will become effective 09/23/2016.

The following policy criteria have been revised:
  • The administration of parenteral inotropic therapy

The following information has been added to this policy:
  • Compounded drugs administered with an external infusion pump

The following HCPCS codes have been added to this policy:
  • J9039
  • J7999
  • J1575
  • C1772

The following HCPCS codes has been removed representing Blinatumomab:
  • J7799

The following HCPCS code has been removed from this policy:
  • J1562

MA05.053b
01/01/2016This version of the policy will become effective 01/01/2016.

The following HCPCS code has been added to this policy:
  • J7340 Carbidopa 5 mg/levodopa 20 mg enteral suspension.

MA05.053a
07/03/2015This version of the policy will become effective 07/03/2015.
  • The following criteria have been added to this policy:
    • Two additional drugs covered on an external infusion pump with criteria: Levodopa-Carbidopa enteral suspension and Blinatumomab
  • The following HCPCS codes have been added to this policy:
    • J1960, J2180, S0020 & S0092, and J2274

Existing durable medical equipment documentation requirements, in accordance with Medicare, are now included with examples.

MA05.053
01/01/2015This is a new policy.

12/17/2014:This policy has been identified for the HCPCS code update, effective 01/01/2015.

The following code was added to this policy:
A4602 Replacement battery for external infusion pump owned by patient, lithium, 1.5 volt, each

The following codes have been deleted.
  • J2271 Injection, morphine sulfate, 100 mg
  • J2275 Injection, morphine sulfate, 100 mg




Version Effective Date: 11/18/2019
Version Issued Date: 11/18/2019
Version Reissued Date: N/A