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LCD - Infusion

Coverage Summary

Written Order Prior to Delivery

External Infusion Pump is covered for any administration of the following:

  1. 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.
  2. Administration of narcotic analgesics (except meperidine) in place of morphine to a patient 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
  3. Administration of the following antifungal or antiviral drugs: acyclovir, foscarnet, amphotericin B, and ganciclovir
  4. Administration of parenteral inotropic therapy, using the drugs dobutamine, milrinone and/or dopamine for patients with congestive heart failure and depressed cardiac function
  5. Administration of epoprostenol or treprostinil for patients with pulmonary hypertension
  6. Gallium nitrate is covered for the treatment of symptomatic cancer-related hypercalcemia In general, patients with serum calcium
  7. Ziconotide is covered for the management of severe chronic pain in patients 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.
  8. Subcutaneous immune globulin

  • When an infusion pump is covered, the drug necessitating the use of the pump and necessary supplies are also covered.

Order Requirements

  1. Patient Name
  2. Specific description of ordered items to be dispensed
  3. Quantity to be dispensed
  4. Dosage or concentration of the drug
  5. Route of Administration
  6. Frequency of administration
  7. Infusion rate / Duration of infusion
  8. Number of refills
  9. Ordering Physician’s NPI
  10. Ordering physician’s legible signature (personally written or electronically signed by the physician, stamps are not accepted by insurance)
  11. Ordering physician’s legible signature date (personally written or electronically signed by the physician, stamps are not accepted by insurance)
  12. Start date of the order – if different than physician signature date.

Coverage Detail

Infusion Medicare LCD

Administration of 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 patient to return to the physician'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 drugs, based on criteria set (1) or (2), using an external infusion pump is limited to the following situations (A) - (H):

A) 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.

B) Administration of narcotic analgesics (except meperidine) in place of morphine to a patient 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

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

D) Administration of parenteral inotropic therapy, using the drugs dobutamine, milrinone and/or dopamine for patients with congestive heart failure and depressed cardiac function if a patient meets all of the following criteria:

  1. Dyspnea at rest or with minimal exertion is present despite treatment with maximum or near maximum tolerated doses of digoxin, a loop diuretic, and an angiotensin converting enzyme inhibitor or another vasodilator (e.g., hydralazine or isosorbide dinitrate), used simultaneously (unless allergic or intolerant), and
  2. Doses are within the following ranges (lower doses will be covered only if part of a weaning or tapering protocol from higher dose levels): II.       Dobutamine - - 2.5-10 mcg/kg/min III.       Milrinone - - 0.375-0.750 mcg/kg/min IV.       Dopamine - - less than or equal to 5 mcg/kg/min, and
  3. Cardiac studies by either invasive hemodynamic technique or using thoracic electrical bioimpedance (impedance cardiography), performed within 6 months prior to the initiation of home inotropic therapy showing (a) cardiac index (CI) is less than or equal to 2.2 liters/min/meter squared and/or pulmonary capillary wedge pressure (PCWP) is greater than or equal to 20 mm Hg before inotrope infusion on maximum medical management and (b) at least a 20% increase in CI and/or at least a 20% decrease in PCWP during inotrope infusion at the dose initially prescribed for home infusion, and
  4. There has been an improvement in patient well being, (less dyspnea, improved diuresis, improved renal function and/or reduction in weight) with the absence of dyspnea at rest at the time of discharge and the capability of outpatient evaluation by the prescribing physician at least monthly, and
  5. In the case of continuous infusion, there is documented deterioration in clinical status when the drug(s) is tapered or discontinued under observation in the hospital, or in the case of intermittent infusions, there is documentation of repeated hospitalizations for congestive heart failure despite maximum medical management, and
  6. Any life threatening arrhythmia is controlled prior to hospital discharge and there is no need for routine electrocardiographic monitoring at home, and
  7. The patient is maintained on the lowest practical dose and efforts to decrease the dose of the drug(s) or the frequency/duration of infusion are documented during the first 3 months of therapy, and
  8. The patient’s cardiac symptoms, vital signs, weight, lab values, and response to therapy are routinely assessed and documented in the patient’s medical record.

E) Administration of epoprostenol or treprostinil for patients with pulmonary hypertension if they meet the following disease criteria:

  1. 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
  2. The patient 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:
    1. The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and
    2. The mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion; and
    3. The patient has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and
    4. 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 only.

F) Gallium nitrate is covered for the treatment of symptomatic cancer-related hypercalcemia In general, patients 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.

G) Ziconotide is covered for the management of severe chronic pain in patients 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.

H) Subcutaneous immune globulin is covered only if criteria 1 and 2 are met:

    1. The subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and
    2. The patient has a diagnosis of primary immune deficiency disease.

  • 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.

NOTE:

When an infusion pump is covered, the drug necessitating the use of the pump and necessary supplies are also covered.