LCD L33794: External Infusion Pumps

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• Refer to the Supplier Manual for additional information on documentation requirements.

• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Payment may be made for supplies that are necessary for the effective use of durable medical equipment. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment or to assure the proper functioning of the equipment. However, the coverage of such drugs or biologicals does not preclude the need for a determination that the drug or biological itself is reasonable and necessary for treatment of the illness or injury or to improve the functioning of a malformed body member.

An external infusion pump is covered for the following indications (I-V):

An infusion pump described by codes E0779, E0780, E0781, and E0791 is covered for indications I – III, V(A) – V(D), V(F), V(G), V(I) and V(J). Coverage of other pumps is addressed under indications IV, V(E), and V(H).

• Administration of deferoxamine for the treatment of chronic iron overload.

• Administration of chemotherapy for the treatment of primary hepatocellular carcinoma or colorectal cancer where this disease is unresectable or where the beneficiary refuses surgical excision of the tumor. Anticancer chemotherapy drugs used in these conditions are not required to meet the criteria described by indication V, situation A.

• 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 (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.) if criterion A or B is met and if criterion C or D is met:

• C-peptide testing requirement – must meet criterion 1 or 2 and criterion 3:

• C-peptide level is less than or equal to 110 percent of the lower limit of normal of the laboratory's measurement method.

• For beneficiaries 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 per cent of the lower limit of normal of the laboratory’s measurement method.

• 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 beneficiary 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 (1 - 5) 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 beneficiary has been on an external insulin infusion pump prior to enrollment in Medicare and has documented frequency of glucose self-testing an average of at least 4 times per day during the month prior to Medicare enrollment.

If criterion A or B is not met, the pump and related accessories, supplies, and insulin will be denied as not reasonable and necessary. If criterion C or D is not met, the pump and related accessories, supplies, and insulin will be denied as not reasonable and necessary.

Continued coverage of an external insulin pump and supplies requires that the beneficiary be seen and evaluated by the treating practitioner at least every 3 months. In addition, the external insulin infusion pump must be ordered and follow-up care rendered by a practitioner who manages multiple beneficiaries 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.

Subcutaneous insulin is administered using ambulatory infusion pump E0784. Claims for usage of infusion pumps other than E0784 will be denied as not reasonable and necessary.

The HCPCS code combination of E0784 plus E2103 is used to describe external ambulatory insulin infusion pumps that incorporate dose rate adjustment using non-adjunctive continuous glucose sensing. Coverage for this HCPCS code combination is only met if the beneficiary meets all of the coverage criteria for insulin pumps outlined in this policy and all criteria for CGMs as outlined in the Glucose Monitors LCD (L33822).

For claims with dates of service on or after April 1, 2022, the HCPCS code combination of E0784 plus E2102 is used to describe external ambulatory insulin infusion pumps with integrated adjunctive continuous glucose monitor receiver functionality. Coverage for this HCPCS code combination is only met if the beneficiary meets all of the coverage criteria for insulin pumps outlined in this policy and all criteria for CGMs as outlined in the Glucose Monitors LCD (L33822).

Refer to the GENERAL section below, and to the CODING GUIDELINES section in the LCD-related Policy Article for additional information regarding supplies used in conjunction with insulin infusion pumps (E0784).

Claims with dates of service on or after January 01, 2017 for supply HCPCS codes A4221, A4222 and K0552, when used with an external infusion pump HCPCS code E0784 will be denied as incorrect coding.

• Administration of other drugs if either of the following sets of criteria (1) or (2) are met:

• Criteria set 1:

• Parenteral administration of the drug in the home is reasonable and 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 reasonable and 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 beneficiary to return to the practitioner's office prior to the beginning of each infusion

• Systemic toxicity or adverse effects of the drug are unavoidable without infusing it at a strictly controlled rate as indicated in the Physicians Desk Reference, or the U.S. Pharmacopeia Drug Information

Coverage for the administration of other drugs, based on criteria set (1) or (2), using an external infusion pump is limited to the following situations (A) - (J):

• 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

• Administration of narcotic analgesics (except meperidine) in place of morphine to a beneficiary 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

• Administration of the following antifungal or antiviral drugs: acyclovir, foscarnet, amphotericin B, and ganciclovir

• Administration of parenteral inotropic therapy using the drugs dobutamine (J1250), milrinone (J2260) or dopamine (J1265) for beneficiaries 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, if a beneficiary meets all of the following criteria:

• Remains symptomatic despite optimal guideline directed medical therapy (GDMT) as defined below; and,

• As “Bridge” therapy for patients eligible for and awaiting mechanical circulatory support (MCS)/cardiac transplantation, or as palliative care for patients not eligible for either MCS/cardiac transplantation; and,

• Prescribed following an evaluation by a cardiologist with training in the management of advanced heart failure; and,

• There has been a documented improvement in beneficiary symptoms of heart failure while on the selected inotropic drug at the time of discharge from an inpatient or skilled nursing care facility; and,

• An evaluation every three months by the prescribing provider or a heart failure team with oversight by a cardiologist with training in the management of advanced heart failure, which documents the beneficiary’s cardiac symptoms and the continuing response and need for therapy. The heart failure team or practitioner may have no financial relationship with the supplier.

Guideline-directed medical therapy (GDMT) is compliance with optimal medical therapy as defined by ACCF/AHA guideline–recommended therapies (primarily Class I recommendations). These include the use of diuretics, ACE inhibitors or ARB antagonists, beta-blockers, aldosterone antagonists, hydralazine & isosorbide dinitrate, and statins, as appropriate.

For an external infusion pump and related inotropic drugs covered prior to 12/01/2015, if the Medicare coverage criteria in effect on the initial date of service were met, the pump and drug(s) will continue to be covered for claims with dates of service on or after 12/01/2015 as long as the beneficiary continues to meet medical need.

• Administration of epoprostenol (J1325) or treprostinil (J3285) for beneficiaries with pulmonary hypertension if they meet the following disease criteria:

• The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease, etc.) or disorders of the respiratory system (e.g., chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders, etc.); and

• The beneficiary has primary pulmonary hypertension or pulmonary hypertension, which is secondary to one of the following conditions: connective tissue disease, thromboembolic disease of the pulmonary arteries, human immunodeficiency virus (HIV) infection, cirrhosis, diet drugs, congenital left to right shunts, etc. If these conditions are present, the following criteria must be met:

• The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and,

• The mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion; and,

• The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and,

• Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.

• Epoprostenol/treprostinil is administered using ambulatory infusion pump K0455. Claims for usage of infusion pumps other than K0455 will be denied as not reasonable and necessary.

• Gallium nitrate (J7799) is covered for the treatment of symptomatic cancer-related hypercalcemia (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.). In general, beneficiaries 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. Use for more than 5 days will be denied as not reasonable and necessary.

More than one course of treatment for the same episode of hypercalcemia will be denied as not reasonable and necessary.

• Ziconotide (J2278) is covered for the management of severe chronic pain in beneficiaries 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) (see Group 3 HCPCS codes) is covered when criteria 1-3, AND criterion 4 or 5 are met:

• The subcutaneous immune globulin preparation is a pooled plasma derivative which is FDA-approved; and,

• The SCIg is administered in the home; and,

• The treating practitioner has determined that administration of the SCIg in the patient's home is medically necessary and appropriate; and,

• The beneficiary has a primary immune deficiency disorder (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.); OR,

• The beneficiary has a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) that has responded to IVIg treatment (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.).

Coverage of subcutaneous immune globulin applies only to those products that are specifically labeled as subcutaneous administration products. Intravenous immune globulin products are not covered under this LCD.

If a drug and pump combination is used, other than those listed in the table in the LCD-related Policy Article, the pump and drug will be denied as not reasonable and necessary (see Coding Guidelines section of the LCD-related Policy Article).

• Infusion-based therapy (including enteral suspension) for the treatment of Parkinson’s Disease will be covered if criterion 1 and either criterion 2 or 3 are met (refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses):

• The beneficiary is diagnosed with levodopa-responsive idiopathic Parkinson’s Disease; and,

• The dosage and/or dosing interval of non-infusion-based Parkinson’s Disease therapy cannot be further optimized due to intolerance, dyskinesia and/or other side effects/adverse events, and the beneficiary continues to experience all of the following:

• Inadequate control of motor fluctuation symptoms affecting daily living (e.g., unpredictable increase in stiffness, tremor, bradykinesia); and,

• A minimum of 2.5 hours of “off” time per day; or

• The beneficiary is currently being treated with an infusion-based Parkinson’s Disease therapy and is being transitioned to a different infusion-based Parkinson’s Disease therapy.

• Blinatumomab (J9039) is covered for adult and pediatric beneficiaries (one month or older) who meet one of the following coverage criteria:

• Up to nine (9) cycles for the treatment of relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL); or

• Up to four (4) cycles for the treatment of B-cell precursor ALL in first or second remission with minimal residual disease (MRD) greater than or equal to 0.1%; or,

• Up to four (4) cycles for the treatment of CD19-positive, Philadelphia chromosome-negative, B-cell precursor ALL in the consolidation phase of multiphase chemotherapy.

(Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.)

Maximum utilization is 875 units of service (UOS), which is equivalent to 25 vials per month. Claims for more than 875 UOS (25 vials) will be denied as not reasonable and necessary. Refer to the CODING GUIDELINES section of the LCD-related Policy Article for information regarding units of service.

GENERAL

N/A