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.

A small volume nebulizer (A7003, A7004, A7005), and related compressor (E0570)
are considered for coverage when it is reasonable and necessary to administer
the following FDA-approved inhalation solutions listed below (refer to the
Group 3 Codes in the LCD-related Policy Article for applicable diagnoses):

  1. It is reasonable and necessary to administer albuterol (J7611, J7613), arformoterol (J7605), budesonide (J7626), cromolyn (J7631), formoterol (J7606), ipratropium (J7644), levalbuterol (J7612, J7614), metaproterenol (J7669), or revefenacin (J7677) for the management of obstructive pulmonary disease (refer to the Group 8 Codes in the LCD-related Policy Article for applicable diagnoses); or

  2. It is reasonable and necessary to administer dornase alfa (J7639) to a beneficiary with cystic fibrosis (refer to the Group 9 Codes in the LCD-related Policy Article for applicable diagnoses); or

  3. It is reasonable and necessary to administer tobramycin (J7682) to a beneficiary with cystic fibrosis or bronchiectasis (refer to the Group 10 Codes in the LCD-related Policy Article for applicable diagnoses); or

  4. It is reasonable and necessary to administer pentamidine (J2545) to a beneficiary with HIV, pneumocystosis, or complications of organ transplants (refer to the Group 4 Codes in the LCD-related Policy Article for applicable diagnoses); or

  5. It is reasonable and necessary to administer acetylcysteine (J7608) for persistent thick or tenacious pulmonary secretions (refer to the Group 7 Codes in the LCD-related Policy Article for applicable diagnoses).

Compounded inhalation solutions (J7604, J7607, J7609, J7610, J7615, J7622,
J7624, J7627, J7628, J7629, J7632, J7634, J7635, J7636, J7637, J7638, J7640,
J7641, J7642, J7643, J7645, J7647, J7650, J7657, J7660, J7667, J7670, J7676,
J7680, J7681, J7683, J7684, J7685, and compounded solutions billed with J7699)
will be denied as not reasonable and necessary.  
  
If none of the drugs used with a nebulizer are covered, the compressor, the
nebulizer, and other related accessories/supplies will be denied as not
reasonable and necessary.  
  
A large volume nebulizer (A7007, A7017), related compressor (E0565 or E0572),
and water or saline (A4217 or A7018) are considered for coverage when it is
reasonable and necessary to deliver humidity to a beneficiary with thick,
tenacious secretions, who has cystic fibrosis, bronchiectasis, a tracheostomy,
or a tracheobronchial stent (refer to the Group 5 Codes in the LCD-related
Policy Article for applicable diagnoses). Combination code E0585 will be
covered for the same indications.  
  
An E0565 or E0572 compressor and filtered nebulizer (A7006) are considered for
coverage when it is reasonable and necessary to administer pentamidine to
beneficiaries with HIV, pneumocystosis, or complications of organ transplants
(refer to the Group 1 Codes in the LCD-related Policy Article for applicable
diagnoses).  
  
A small volume ultrasonic nebulizer (E0574) and related accessories are
considered for coverage when it is reasonable and necessary to administer
treprostinil inhalation solution to beneficiaries with pulmonary hypertension
only (refer to the Group 11 Codes in the LCD-related Policy Article for
applicable diagnoses). Claims for code E0574 used with other inhalation
solutions will be denied as not reasonable and necessary.  
  
Treprostinil inhalation solution (J7686) is considered for coverage when
either criteria 1-3; **or** , criterion 4 are met:

  1. The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 11 Codes in the LCD-related Policy Article for applicable diagnoses); and

  2. The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease) or disorders of the respiratory system other than interstitial lung disease (see criterion 4) (e.g., chronic obstructive pulmonary disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders); and

  3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present, the following criteria (a-d) 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 > 25 mm Hg at rest or > 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.

  4. The beneficiary has a diagnosis of pulmonary hypertension associated with interstitial lung disease (refer to Group 11 Codes in the LCD-related Policy Article for applicable diagnoses) and the following criteria (a-e) are met:

    1. The presence of interstitial lung disease has been confirmed by a high-resolution CT scan of the chest; and

    2. The mean pulmonary artery pressure is  25 mm Hg; and

    3. The pulmonary capillary wedge pressure or left ventricular end-diastolic pressure is  15mm Hg; and

    4. The pulmonary vascular resistance is  3 Wood Units at rest; and

    5. The beneficiary has significant symptoms of pulmonary hypertension (e.g., dyspnea on exertion, fatigability)

If the above criteria are not met, code E0574 and the related drug
treprostinil (J7686) will be denied as not reasonable and necessary.  
  
A controlled dose inhalation drug delivery system (K0730) is considered for
coverage when it is reasonable and necessary to administer iloprost (Q4074) to
beneficiaries with pulmonary hypertension only (refer to the Group 14 Codes in
the LCD-related Policy Article for applicable diagnoses). Claims for code
K0730 for use with other inhalation solutions will be denied as not reasonable
and necessary.  
  
Iloprost (Q4074) is considered for coverage when all of the following criteria
1-3 are met:

  1. The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 14 Codes in the LCD-related Policy Article for applicable diagnoses); and

  2. The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease) 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); and

  3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present, the following criteria (a-d) 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 > 25 mm Hg at rest or > 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.

If the above criteria are not met, code K0730 and the related drug iloprost
(Q4074) will be denied as not reasonable and necessary.

A large volume ultrasonic nebulizer (E0575) offers no proven clinical
advantage over a pneumatic compressor and nebulizer and will be denied as not
reasonable and necessary.  
  
  
_ACCESSORIES:_  
  
Accessories are separately payable if the related aerosol compressor and the
individual accessories are reasonable and necessary. The following table lists
the compressor/generator, which is related to the accessories described. Other
compressor/generator/accessory combinations are considered not reasonable and
necessary.  
  

Compressor/Generator | Related Accessories  
---|---  
E0565 | A4619, A7006, A7007, A7010, A7012, A7013, A7014, A7015, A7017, A7525,
E1372  
E0570 | A7003, A7004, A7005, A7006, A7013, A7015, A7525  
E0572 | A7006, A7007, A7014, A7017  
E0574 | A7013, A7014, A7016  
E0585 | A4619, A7006, A7010, A7012, A7013, A7014, A7015, A7525  
K0730 | A7005  
  
  
This array of accessories represents all possible combinations, but it may not
be appropriate to bill any or all of them for one device.  
  
The following table lists the usual maximum frequency of replacement for
accessories. Claims for more than the usual maximum replacement amount will be
denied as not reasonable and necessary.

Accessory |  Usual maximum replacement  
---|---  
A4619 |  One/month  
A7003 |  Two/month  
A7004 |  Two/month (in addition to A7003)  
A7005 |  One/6 months  
A7005 |  One/3 months only with K0730  
A7006 |  One/month  
A7007 |  Two/month  
A7010 |  One unit (100 ft.)/2 months  
A7012 |  Two/month  
A7013 |  Two/month  
A7014 |  One/3 months  
A7015 |  One/month  
A7016 |  Two/year  
A7017 |  One/3 years  
A7525 |  One/month  
E1372 |  One/3 years  
  
  
  
_  INHALATION DRUGS AND SOLUTIONS:_  
  
The following table represents the maximum milligrams/month of inhalation
drugs that are reasonable and necessary for each nebulizer drug.  
  

Inhalation Drugs and Solutions | Maximum Milligrams/Month  
---|---  
Acetylcysteine | 74 grams/month  
Albuterol | 465 mg/month (See below for exception)  
Albuterol/Ipratropium combination | 186 units/month  
Arformoterol | 930 micrograms/month - 62 units/month  
Budesonide | 62 units/month  
Cromolyn sodium | 2480 mg/month - 248 units/month  
Dornase alfa | 78 mg/month  
Formoterol | 1240 micrograms/month - 62 units/month  
Ipratropium bromide | 93 mg/month  
Levalbuterol | 232.5 mg/month - 465 units/month (See below for exception)  
Metaproterenol | 2800 mg/month - 280 units/month (See below for exception)  
Pentamidine | 300 mg/month  
Revefenacin | 5250 mcg/month  
Treprostinil | 31 units/month  
Sterile saline or water, 10ml/unit (A4216, A4218) | 56 units/month  
Distilled water, sterile water, or sterile saline in large volume nebulizer |
18 liters/month  
  


Claims for more than these amounts of drugs will be denied as not reasonable
and necessary.

When albuterol, levalbuterol, or metaproterenol are prescribed as
rescue/supplemental medication for beneficiaries who are taking formoterol or
arformoterol, the maximum milligrams/month that are reasonably billed are:  
  

Inhalation Drugs and Solutions | Maximum Milligrams/Month  
---|---  
Albuterol | 78 mg/month  
Albuterol/Ipratroprium combination | 31 units/month  
Levalbuterol | 39 mg/month - 78 units/month  
Metaproterenol | 470 mg/month - 47 units/month  
  


Claims for more than these amounts of drugs will be denied as not reasonable
and necessary.  
  
When a "concentrated form" of an inhalation drug is covered, separate saline
solution (A4216 or A4218 [metered dose]) used to dilute it will be separately
reimbursed. Saline dispensed for the dilution of concentrated nebulizer drugs
must be billed on the same claim as the drug(s) being diluted. If the unit
dose form of the drug is dispensed, separate saline solution (A4216 or A4218
[metered dose]), will be denied as not reasonable and necessary. Water or
saline in 500 or 1000 ml quantities (A4217 or A7018) are not appropriate for
use by beneficiaries to dilute inhalation drugs and will therefore be denied
as not reasonable and necessary if used for this purpose. These codes are only
reasonable and necessary when used in a large volume nebulizer (A7007, A7017,
or E0585).  
  
Albuterol, levalbuterol, and metaproterenol are all short-acting
bronchodilators with beta-adrenergic stimulatory effect. It is not reasonable
and necessary for a beneficiary to use more than one of these at a time. The
use of more than one of these drugs at the same time will be denied as not
reasonable and necessary.  
  
Albuterol, levalbuterol, or metaproterenol is covered if it is used as a
rescue/supplemental medication in addition to the long-acting beta-adrenergic
agonist drug, formoterol or arformoterol.  
  
Formoterol and arformoterol are long-acting bronchodilators with beta-
adrenergic stimulatory effect. It is not reasonable and necessary for a
beneficiary to use more than one of these at a time. The use of more than one
of these drugs at the same time will be denied as not reasonable and
necessary.

Revefenacin (J7677) is a long-acting muscarinic antagonist. Concurrent use of
long-acting and short-acting muscarinic antagonists, such as ipratropium
(J7644) is not reasonable and necessary. Therefore, if a long-acting
muscarinic antagonist is used, the short-acting muscarinic antagonist will be
denied as not reasonable and necessary.

Code J7620 describes the FDA-approved unit dose combination of albuterol base
2.5 mg and ipratropium bromide 0.5 mg in unit dose vials. The medical
necessity for administering additional albuterol sulfate (J7611, J7613),
levalbuterol (J7612, J7614) and/or ipratropium bromide (J7644) has not been
established. Claims for J7611, J7612, J7613, J7614, and J7644 billed in
addition to J7620 will be denied as not reasonable and necessary.  
  
Charges for the drugs, diluent, and dispensing fees 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 submit a claim for nebulizer drugs.
Practitioners may submit a claim for drugs if all of the following conditions
are met: the practitioner is 1) enrolled as a durable medical equipment,
prosthetics, orthotics and supplies (DMEPOS) supplier with the National
Supplier Clearinghouse, and 2) dispensing the drug(s) to the Medicare
beneficiary, and 3) authorized by the State to dispense drugs as part of the
practitioner's license. Claims submitted by entities not licensed to dispense
drugs will be denied for lack of medical necessity.  
  
GENERAL

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 Nebulizers LCD-related Policy Article.)