Medicare Advantage

Medical Policy

Notification

External Infusion Pumps

Notification Issue Date: 3/10/2023 9:00 AM

The following new policy has been developed to continue to communicate our Company's coverage criteria for external infusion pumps. The information on external infusion pumps has been transferred from policy MA05.053l Implantable Infusion Pumps.

This policy will become effective on 04/10/2023.

Title:

External Infusion Pumps

Policy #:

MA05.060

Policy

MEDICALLY NECESSARY

An external infusion pump is considered medically necessary and, therefore, covered for any of the following criteria:

CHRONIC IRON OVERLOAD

Administration of deferoxamine, with the use of an external infusion pump (E0779, E0780, E0781, and E0791), for the treatment of chronic iron overload

PRIMARY HEPATOCELLULAR CARCINOMA OR COLORECTAL CANCER

Administration of chemotherapy, with the use of an external infusion pump (E0779, E0780, E0781, and E0791), 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

INTRACTABLE PAIN

Administration of morphine, with the use of an external infusion pump (E0779, E0780, E0781, and E0791), for the treatment of intractable pain caused by cancer

DIABETES MELLITUS

Administration of continuous subcutaneous insulin, with the use of an external infusion pump (E0784), for the treatment of diabetes mellitus when the following criteria are met:

When either of the following testing requirements are met:

The individual has a fasting blood sugar (obtained at the same time as the C-peptide level) which is less than or equal to 225 mg/dL. In addition, a C-peptide test must be obtained 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

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

The individual has a positive beta cell autoantibody test.

In addition to the above testing requirements, either of the following must be met:

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 three 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 DRUGS

Administration of other drugs as specified below are covered when the following criteria are met:

Either Criteria Set 1 or Criteria Set 2 are 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.

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.

In addition to the above criteria sets, one of the following situations must be met:

Anticancer Chemotherapy

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.

Narcotic Analgesics

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.

Antifungal or Antiviral Drugs

The administration of the following antifungal or antiviral drugs: acyclovir, foscarnet, amphotericin B, and ganciclovir.

Inotropic Therapy

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 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.

Epoprostenol or Teprostinil

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).

Gallium Nitrate

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.

Ziconotide

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.

Subcutaneous Immune Globulin (SCIG)

The administration of an FDA-approved pooled plasma derivative, subcutaneous immune globulin (SCIG) (J1559, J1561, J1569, J1575, J1551) is considered medically necessary and, therefore, covered when the following are met*:

Either of the following documented conditions must be met:

Primary Immune Deficiency Disease
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (J1559) that has responded to intravenous immune globulin (IVIG) treatment (please refer to the specific policy on Immune Globulin: Intravenous [IVIG], Subcutaneous [SCIG])

In addition to the above conditions, all of the following criteria must be met:

SCIG is covered when the medication is administered in the home.
The home adminstration has been determined to be medically necessary and appropriate by the prescribing professional provider.

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.

Levodopa-Carbidopa Enteral Suspension (Duopa)

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).

Blincyto®

The administration of blinatumomab (Blincyto) (J9039) on an external infusion pump for the treatment of pediatric and adult individuals with acute lymphoblastic leukemia (ALL). (Please refer to the specific policies titled Medicare Part B vs. Part D Crossover Drugs and 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.

An external infusion pump and related drugs and supplies in the home setting for the treatment of thromboembolic disease and/or pulmonary embolism by heparin infusion 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) or supplies used with an insulin infusion pump (A4225) 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, E0787, or K0455).

Disposable drug delivery systems (A4305, A4306, 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.

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 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 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.

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

Guidelines

This policy is consistent with Medicare’s coverage determination for 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, 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

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 (AANS). Neurosurgical conditions and treatments: Spasticity. Available at: https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed on 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.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia. V1. 2022. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp [via subscription only]. Accessed January 26, 2023.

Noridian Healthcare Solutions, LLC. 2023 HCPCS Code Update- January Edition- Correct Coding. 01/19/2023. Available at: https://med.noridianmedicare.com/web/jadme/policies/dmd-articles/2023/2023-hcpcs-code-update-january-edition-correct-coding. Accessed January 26, 2023.

Noridian Healthcare Solutions, LLC. Local Coverage Article: External Infusion Pumps (A52507). Original: 10/01/2015. Revised: 10/01/2022. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52507. Accessed January 26, 2023.

Noridian Healthcare Solutons, LLC. Local Coverage Determination (LCD): External Infusion Pumps (L33794). Original 10/01/2015. Revised 07/01/2022. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33794. Accessed January 26, 2023.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Blinatumomab (Blincyto) approval letter and prescribing information. [FDA Web site]. 02/18/2022. Available at:
https://www.accessdata.fda.gov/scripts/cder/daf/#labelinfo. 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.

Yancy Clyde W et al. 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

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

N/A

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

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

E0787 External ambulatory infusion pump, insulin, dosage rate adjustment using therapeutic continuous glucose sensing

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 EXTERNAL INFUSION PUMPS

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 EXTERNAL 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

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

J1551 Injection, immune globulin (Cutaquig), 100 mg

J1555 Injection, immune globulin (Cuvitru), 100 mg

J1558 Injection, immune globulin (xembify), 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

J1574 Injection, ganciclovir sodium (Exela) not therapeutically equivalent to J1570, 500 mg

J1575 Injection, immune globulin/hyaluronidase, 100 mg immuneglobulin

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

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

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

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

NOT COVERED

A4305 Disposable drug delivery system, flow rate of 50 ml or greater per hour

A4306 Disposable drug delivery system, flow rate of less than 50 ml per hour

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

THE FOLLOWING CODE IS USED TO REPRESENT AN EXTERNAL INFUSION CONTROLLER DEVICE
E1399 Durable medical equipment, miscellaneous

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

4/10/2023

Version Issued Date: