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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. For the items addressed in this
medical policy, the criteria for "reasonable and necessary" are
defined by the following indications and limitations of coverage and/or
medical necessity.
For an item to be covered by Medicare a written signed and dated order must
be received by the supplier before a claim is submitted. If the supplier
bills for an item addressed in this policy without first receiving the
completed order, the item will be denied as not medically necessary.
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), and V(G). 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 patient 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 (ICD-9 codes 250.00-250.93) 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 patients
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 patient
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 patient
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 medically necessary. If criterion C or D
is not met, the pump and related accessories, supplies, and insulin will be
denied as not medically necessary.
Continued coverage of an external insulin pump and supplies requires that
the patient be seen and evaluated by the treating physician at least every
3 months. In addition, the external insulin infusion pump must be ordered
and follow-up care rendered by a physician who manages multiple patients 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
medically necessary.
- 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 patient to
return to the physician's office prior to the beginning of each
infusion.
- Systemic
toxicity or adverse effects of the drug is 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) - (H):
- Administration
of the anticancer chemotherapy drugs cladribine,
fluorouracil, cytarabine, bleomycin, floxuridine,
doxorubicin (non-liposomal), vincristine 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 patient with intractable pain caused by
cancer who 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. Liposomal
amphotericin B preparations (J0287-J0289)
are covered for patients who meet one of the following criteria:
- The patient
has suffered some significant toxicity that would preclude the use
of standard amphotericin B and is unable
to complete the course of therapy without the liposomal
form, or
- The patient
has significantly impaired renal function.
If these criteria are not met, payment will be based on the allowance for
the least costly medically appropriate alternative, standard amphotericin B (J0285).
- 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:
- 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
- Doses are
within the following ranges (lower doses will be covered only if
part of a weaning or tapering protocol from higher dose levels):
- Dobutamine - - 2.5-10 mcg/kg/min
- Milrinone - - 0.375-0.750 mcg/kg/min
- Dopamine -
- less than or equal to 5 mcg/kg/min, and
- 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
- 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
- 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
- Any life
threatening arrhythmia is controlled prior to hospital discharge and
there is no need for routine electrocardiographic
monitoring at home, and
- 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
- 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.
- Administration
of epoprostenol (J1325) or treprostinil (J3285) for patients 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 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:
a. The pulmonary
hypertension has progressed despite maximal medical and/or surgical
treatment of the identified condition; and
b. The mean pulmonary
artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg
with exertion; and
c. The patient has
significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina,
or syncope); and
d. Treatment with oral
calcium channel blocking agents has been tried and failed, or has been
considered and ruled out.
Subcutaneous epoprostinol/treprostinil is
administered using ambulatory infusion pump K0455. Claims for usage of
infusion pumps other than K0455 will be denied as not medically necessary.
- Gallium nitrate (J1457) is
covered for the treatment of symptomatic cancer-related hypercalcemia (ICD-9 275.42). 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 that 5 days will be denied as not
medically necessary.
More than one course of treatment for the same episode of hypercalcemia will be denied as not medically
necessary.
- Ziconotide (J2278) 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.
- Subcutaneous
immune globulin (J1562) is covered only if criteria 1 and 2 are met:
- The
subcutaneous immune globulin preparation is a pooled plasma
derivative which is approved for the treatment of primary immune
deficiency disease; and
- The patient
has a diagnosis of primary immune deficiency disease (ICD-9 codes
279.04, 279.05, 279.06, 279.12, 279.2).
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.
Subcutaneous immune globulin is administered using ambulatory infusion pump
E0779. Claims for usage of infusion pumps other than E0779 will be denied
as not medically necessary.
External infusion pumps and related drugs and supplies will be denied as
not medically necessary when the criteria described by indication (I),
(II), (III), (IV) or (V) are not met.
When an infusion pump is covered, the drug necessitating the use of the
pump and necessary supplies are also covered. When a pump has been
purchased by the Medicare program, other insurer, or the patient, or the
rental cap has been reached, the drug necessitating the use of the pump,
and supplies are covered as long as the coverage criteria for the pump are
met.
An external infusion pump and related drugs and supplies will be denied as
not medically necessary in the home setting for the treatment of thromboembolic disease and/or pulmonary embolism by
heparin infusion.
An infusion controller device (E1399) is not medically necessary.
An IV pole (E0776) is covered only when a stationary infusion pump (E0791)
is covered. It is considered not medically necessary if it is billed with
an ambulatory infusion pump (E0779, E0780, E0781, E0784, or K0455).
Supplies for the maintenance of a parenteral drug infusion catheter (A4221)
are covered during the period of covered use of an infusion pump. They are
also covered for the weeks in between covered infusion pump use, not to
exceed 4 weeks per episode.
Supplies used with an external infusion pump, A4222 or K0552, are covered
during the period of covered use of an infusion pump. Allowance is based on
the number of cassettes or bags (A4222) prepared or syringes (K0552) used.
For intermittent infusions, no more than one cassette or bag is covered for
each dose of drug. For continuous infusion, the concentration of the drug
and the size of the cassette, bag, or syringe should be maximized to result
in the fewest cassettes, bags, or syringes in keeping with good
pharmacologic and medical practice.
Drugs and supplies that are dispensed but not used for completely
unforeseen circumstances (e.g., emergency admission to hospital, drug
toxicity, etc.) are covered. Suppliers are expected to anticipate changing
needs for drugs (e.g., planned hospital admissions, drug level testing with
possible dosage change, etc.) in their drug and supply preparation and
delivery schedule.
Charges for drugs administered by a DME infusion pump may only be billed by
the entity that actually dispenses the drug to the Medicare beneficiary and
that entity must be permitted under all applicable federal, state, and
local laws and regulations to dispense drugs. Only entities licensed in the
state where they are physically located may bill for infusion drugs. Drugs
and related supplies and equipment billed by a supplier who does not meet
these criteria will be denied as not medically necessary.
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