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).

  1. Administration of deferoxamine for the treatment of chronic iron overload.
  2. 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.
  3. Administration of morphine when used in the treatment of intractable pain caused by cancer.
  4. 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: 
    1. C-peptide testing requirement - must meet criterion 1 or 2 and criterion 3:  

      1. C-peptide level is less than or equal to 110 percent of the lower limit of normal of the laboratory's measurement method.
      2. 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.
      3. A fasting blood sugar obtained at the same time as the C-peptide level is less than or equal to 225 mg/dl.
    2. Beta cell autoantibody test is positive.
    3. 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: 
      1. Glycosylated hemoglobin level (HbA1C) greater than 7 percent
      2. History of recurring hypoglycemia
      3. Wide fluctuations in blood glucose before mealtime
      4. Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL
      5. History of severe glycemic excursions
    4. 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.  
  

  5. 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):

    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 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

    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 (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: 
      1. Remains symptomatic despite optimal guideline directed medical therapy (GDMT) as defined below; and,
      2. 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,
      3. Prescribed following an evaluation by a cardiologist with training in the management of advanced heart failure; and,
      4. 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,
      5. 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.

    5. Administration of epoprostenol (J1325) or treprostinil (J3285) for beneficiaries 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 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: 
        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 beneficiary 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.
        5. 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.
    6. Gallium nitrate (J1457) 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.  
  

    7. 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.
    8. Subcutaneous immune globulin (SCIg) (see Group 3 HCPCS codes) is covered when criteria 1-3, AND criterion 4 or 5 are met: 
      1. The subcutaneous immune globulin preparation is a pooled plasma derivative which is FDA-approved; and,
      2. The SCIg is administered in the home; and,
      3. The treating practitioner has determined that administration of the SCIg in the patient's home is medically necessary and appropriate; and,
      4. The beneficiary has a primary immune deficiency disorder (Refer to the Group 3 ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.); OR,
      5. The beneficiary has a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) that has responded to IVIg treatment (Refer to the Group 6 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).

    9. Levodopa-Carbidopa enteral suspension (J7340) is only covered for treatment of motor fluctuations in beneficiaries with Parkinson's disease (PD), who meet all of the following criteria (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.): 
      1. The beneficiary has been evaluated by a neurologist, who prescribes and manages treatment with the drug; and,
      2. Idiopathic PD based on the presence of bradykinesia and at least one other cardinal PD features (tremor, rigidity, postural instability); and,
      3. L-dopa responsive with clearly defined "On" periods; and,
      4. 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. COMT inhibitor or MAO-B inhibitor.

Levodopa-Carbidopa enteral suspension is not reasonable and necessary for
patients with any of the following:

    9.       1. Atypical Parkinson's syndrome ("Parkinson's Plus" syndrome) or secondary Parkinson's; or
      2. Non-levodopa responsive PD; or,
      3. Contraindication to percutaneous endoscopic gastro-jejunal (PEG-J) tube placement or long-term use of a PEG-J.

Establishment of the transabdominal port with a PEG-J is performed under
endoscopic guidance by a gastroenterologist or other healthcare provider
experienced in this procedure. The PEG-J is considered a supply provided
incident to a physician's service, and claims for this item are processed by
the A/B MAC contractor. Claims to the DME MAC for the PEG-J will be rejected
as wrong jurisdiction.

    10. Blinatumomab (J9039) is only covered for: 
      1. Up to nine (9) cycles for adult and pediatric beneficiaries with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL); or
      2. Up to four (4) cycles for adult and pediatric beneficiaries with B-cell precursor ALL in first or second remission with minimal residual disease (MRD) greater than or equal to 0.1%.

(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
related Policy Article for information regarding units of service.

  
GENERAL

External infusion pumps and related drugs and supplies will be denied as not
reasonable and 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, the beneficiary, 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
reasonable and 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 reasonable and necessary.

An IV pole (E0776) is covered only when a stationary infusion pump (E0791) is
covered. It is considered not reasonable and 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) or
supplies for the maintenance for an insulin infusion pump (A4224) 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 and K0552 or supplies used
with an insulin infusion pump (A4225) 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 (A4225, 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.

Claims with dates of service on or after January 01, 2017 for supply HCPCS
codes A4224 and A4225 used with an external infusion pump other than HCPCS
code E0784 will be denied as incorrect coding.

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 reasonable and necessary.

Compounded drugs NOC (J7999) billed with an external infusion pump will be
denied as not reasonable and necessary. Refer to the CODING GUIDELINES section
of the related Policy Article for information about J7999 coding requirements.

Claims for compounded drugs that do not use code Q9977 or J7999 will be denied
as incorrect coding.

A Standard Written Order (SWO) must be communicated to the supplier before a
claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving a completed SWO, the claim shall be denied as not
reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
base items that require a Written Order Prior to Delivery (WOPD), the supplier
must have received a signed SWO before the DMEPOS item is delivered to a
beneficiary. If a supplier delivers a DMEPOS item without first receiving a
WOPD, the claim shall be denied as not reasonable and necessary. Refer to the
LCD-related Policy Article, located at the bottom of this policy under the
Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed
associated options, accessories, and/or supplies, the supplier must have
received a WOPD which lists the base item and which may list all the
associated options, accessories, and/or supplies that are separately billed
prior to the delivery of the items. In this scenario, if the supplier
separately bills for associated options, accessories, and/or supplies without
first receiving a completed and signed WOPD of the base item prior to
delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines
listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC
articles. Claims that do not meet coding guidelines shall be denied as not
reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be
based on prospective, not retrospective use. For DMEPOS products that are
supplied as refills to the original order, suppliers must contact the
beneficiary, and document an affirmative response, prior to dispensing the
refill and not automatically ship on a pre-determined basis, even if
authorized by the beneficiary. This shall be done to ensure that the refilled
item remains reasonable and necessary, existing supplies are expected to end,
and to confirm any changes or modifications to the order. Contact with the
beneficiary or designee regarding refills must take place no sooner than 30
calendar days prior to the expected end of the current supply. For delivery of
refills, the supplier must deliver the DMEPOS product no sooner than 10
calendar days prior to the expected end of the current supply. This is
regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are
required to have contact with the beneficiary or caregiver/designee and
document an affirmative response, prior to dispensing a new supply of items.
Suppliers must not deliver refills without a refill request and an affirmative
response from a beneficiary. Items delivered without a valid, documented
refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's
expected utilization. Suppliers must stay attuned to changed or atypical
utilization patterns on the part of their clients. Suppliers must verify with
the treating practitioners that any changed or atypical utilization is
warranted.

Regardless of utilization, a supplier must not dispense more than a three (3)
- month quantity at a time.

DRUG WASTAGE

Claims for drugs billed to Medicare must use drug dosage formulations and/or
unit dose sizes that minimize wastage. Medicare provides payment for the
amount of a single use vial or other single use package of drug or biological
discarded, in addition to the dose administered. (See the MODIFIERS section of
the External Infusion Pumps LCD-related Policy Article.)