1. Medicare Guidelines for Respiratory Medications and Supplies
   Note: Monthly allowable amounts do not represent a benefit limit. The actual quantity needed by a particular customer may be more or less than the amount listed, depending on the individual customer's medical condition. Customers ordering over the allowable amount must have appropriate medical justification (i.e. a letter of medical necessity).
   If Medicare determines there is medical necessity, the standard allowable for the following items is listed below. Medicare may sometimes approve larger quantities, but that decision is made on a month-to-month basis by the individuals reviewing the claims. They may approve larger quantities one month, but disapprove them a different month. For the most consistent reimbursement by Medicare, you may want to consider placing one order per month, staying within the limits listed below.
2. Some Medicare Coverage Rules that should be noted (Partial Overview):
   1. A small volume nebulizer (A7003, A7004, A7005) and related compressor (E0570, E0571) are covered when:
      1. It is medically necessary to administer beta-adrenergics, anticholinergics, corticosteroids, and cromolyn for the management of obstructive pulmonary disease (ICD-9 diagnosis codes 491.0 - 505), or
      2. It is medically necessary to administer gentamicin, tobramycin, amikacin, or dornase alfa to a patient with cystic fibrosis (ICD-9 diagnosis code 277.00) or
      3. It is medically necessary to administer pentamidine to patients with HIV (ICD-9 diagnosis code 042), pneumocystosis (ICD-9 diagnosis code 136.3), and complications of organ transplants (ICD-9 diagnosis codes 996.80-996.89), or
      4. It is medically necessary to administer mucolytics (other than dornase alpha) for persistent thick or tenacious pulmonary secretions (ICD-9 diagnosis codes 480.0-505, and 786.4).
   2. Use of inhalation drugs, other than those listed above, will be denied as not medically necessary.
   3. If none of the drugs used with a nebulizer are covered, the nebulizer and its accessories/supplies will be denied as not medically necessary.
   4. A large volume nebulizer (A7017), related compressor (E0565 or E0572), and water or saline (A7018 or A7020) are covered when it is medically necessary to deliver humidity to a patient with thick, tenacious secretions, who has cystic fibrosis (ICD-9 diagnosis code 277.00), bronchiectasis (ICD-9 diagnosis code 494 or 748.61), a tracheostomy (ICD-9 diagnosis code V44.0 or V55.0), a tracheobronchial stent (ICD-9 diagnosis code 519.1). Combination code E0585 will be covered for the same indications.
   5. An E0565 or E0572 compressor and filtered nebulizer (A7006) are also covered when it is medically necessary to administer pentamidine to patients with HIV (ICD-9 diagnosis code 042), pneumocystosis (ICD-9 diagnosis code 136.3) and complications of organ transplants (ICD-9 diagnosis codes 996.80-996.89).
   6. If a large volume nebulizer, related compressor/generator, and water or saline are used predominantly to provide room humidification it will be denied as non-covered.
   7. Because there is no proven medical benefit to nebulizing particles to diameters smaller than achievable with a pneumatic model, when a small volume ultrasonic nebulizer (E0574) is ordered, it will be reimbursed at the least costly alternative of a pneumatic compressor (E0570).
   8. Similarly, a large volume ultrasonic nebulizer (E0575) offers no proven clinical advantage over a pneumatic compressor. However, since code E0575 is in a different payment category than pneumatic compressors, payment for a least costly alternate cannot be made. Therefore, when an E0575 nebulizer is provided, it will be denied as not medically necessary as will any related accessories and supplies.
   9. A battery powered compressor (E0571) is rarely medically necessary. If this compressor is provided without accompanying documentation which justifies its medical necessity, and the coverage criteria for code E0570 are met, payment will be based on the allowance for the least costly medically acceptable alternative, E0570.
   10. Other uses of compressors/generators will be considered individually on a case by case basis, to determine their medical necessity.

1. A large volume pneumatic nebulizer (E0580) and water or saline (A7018 or A7020) are not separately payable and should not be separately billed when used for patients with rented home oxygen equipment.
2. Disposable large volume nebulizers (A7007 and A7008) are non-covered under the DME benefit because they are convenience items. A non-disposable unfilled nebulizer (A7017 or E0585) filled with water or saline (A7018, A7020) by the patient/caregiver is an acceptable alternative.
3. Kits and concentrates for use in cleaning respiratory equipment will be denied as non-covered.
4. Accessories are separately payable if the related aerosol compressor and the individual accessories are medically necessary. The following table lists the compressor/generator which is related to the accessories described. Other compressor/generator/accessory combinations are considered medically unnecessary.

1. This array of accessories represents all possible combinations but it may not be appropriate to bill any or all of them for one device.
2. 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 medically necessary unless the claim is accompanied by documentation, which justifies a larger quantity in the individual case.
3. Accessory (Usual maximum replacement)

Effective 01/01/2003	Quantity Limitations	BLN Assignment?
Face Tent (A4619)	One/month	Assignment on Formulary Products Only
Tracheotomy Mask Or Collar (A4621)	One/month	Assignment on Formulary Products Only
Administration Set, With Small Volume Non-filtered Pneumatic Nebulizer, Disposable (A7003)	Two/month	Assignment on Formulary Products Only
Small Volume Non-filtered Pneumatic Nebulizer, Disposable (A7004)	Two/month (in addition to A7003)	Assignment on Formulary Products Only
Administration Set, With Small Volume Non-filtered Pneumatic Nebulizer, Non-Disposable (A7005)	One/6 months	Assignment on Formulary Products Only
Administration Set, With Small Volume Filtered Pneumatic Nebulizer (A7006)	One/month	Assignment on Formulary Products Only
Corrugated Tubing, Disposable, Used With Large Volume Nebulizer, 100 Feet (A7010)	One unit (100 ft.)/ 2 months	Assignment on Formulary Products Only
Corrugated Tubing, Non-Disposable, Used With Large Volume Nebulizer, 10 Feet (A7011)	One/year	Assignment on Formulary Products Only
Water Collection Device, Used With Large Volume Nebulizer (A7012)	Two/month	Assignment on Formulary Products Only
Filter, Disposable, Used With Aerosol Compressor (A7013)	Two/month	Assignment on Formulary Products Only
Filter, Non-disposable, Used With Aerosol Compressor Or Ultrasonic Generator (A7014)	One/3 months	Assignment on Formulary Products Only
Aerosol Mask, Used With DME Nebulizer (A7015)	One/month	Assignment on Formulary Products Only
Dome And Mouthpiece, Used With Small Volume Ultrasonic Nebulizer (A7016)	Two/year	Assignment on Formulary Products Only
Nebulizer, Durable, Glass Or Autoclavable Plastic, Bottle Type, not used with Oxygen (A7017)	One/3 years	Assignment on Formulary Products Only
Immersion External Heater For Nebulizer (E1372)	One/3 years	Assignment on Formulary Products Only

1. For all inhalation drugs and solutions, claims for dispensed quantities greater than would be reasonable based on usual suggested dosing guidelines will be denied as not medically necessary unless accompanied by medical necessity documentation justifying these unexpected quantities. The pharmacist is responsible for assessing how much inhalation solution a patient is actually using. Considering this information, the pharmacist is responsible for assuring that the patient usually has no more than one month's supply on hand at any time.
2. The following table represents the maximum milligrams/month of inhalation drugs that would be reasonably billed for each nebulized drug. Claims for more than these amounts of drugs will be denied as not medically necessary unless accompanied by documentation, which justifies a larger amount in the individual case.




Effective 01/01/2003	Quantity Limitations	BLN Assignment?
Acetylcysteine, Inhalation Solution, per Gram (J7608)	up to 74 grams/month	Assignment on Formulary Products Only
Albuterol, Inhalation Solution, per 1mg (J7618, J7619) bronchodilator	up to 465 mg/month (465 units/month)	Assignment on Formulary Products Only
Atropine, Inhalation Solution, per 1mg (J7635, J7636) anticholinergic	up to 186 mg/month	Assignment on Formulary Products Only
Bitolterol Mesylate, Inhalation Solution, per 1mg (J7628, J7629) bronchodilator	up to 434 mg/month	Assignment on Formulary Products Only
Cromolyn Sodium, Inhalation Solution, per 10mg (J7631)	up to 2480 mg/month (248 units/month)	Assignment on Formulary Products Only
Dornase Alpha, Inhalation Solution, per 1mg (J7639) covered for patients with cystic fibrosis	up to 78 mg/month	Assignment on Formulary Products Only
Glycopyrrolate, Inhalation Solution, per 1mg (J7642, J7643) anticholinergic	up to 75 mg/month	Assignment on Formulary Products Only
Ipratropium Bromide, Inhalation Solution, per 1mg (J7644) anticholinergic	up to 93 mg/month	Assignment on Formulary Products Only
Isoetharine Hcl, Inhalation Solution, per 1mg (J7648, J7649) bronchodilator	up to 930 mg/month	Assignment on Formulary Products Only
Isoproterenol Hcl, Inhalation Solution, per 1mg (J7658, J7659) bronchodilator	up to 450 mg/month	Assignment on Formulary Products Only
Levalbuterol, Inhalation Solution, per 0.5mg (J7618, J7619) bronchodilator	up to 232.5 mg/month (465 units/month)	Assignment Not Accepted
Metaproterenol Sulfate, Inhalation Solution, per 10mg (J7668, J7669) bronchodilator	up to 2800 mg/month (280 units/month)	Assignment on Formulary Products Only
Pentamidine	up to 300 mg/month	Assignment on Formulary Products Only
Terbutaline Sulfate, Inhalation Solution, per 1mg (J7680, J7681) bronchodilator	up to 186 mg/month	Assignment on Formulary Products Only
Sterile saline or water, up to 5cc/unit (J7051)	up to 186 units/month	Assignment on Formulary Products Only
Saline solution, metered dose, 10 ml/unit (A7019)	up to 60 units/month	Assignment on Formulary Products Only
Distilled water, sterile water, or sterile saline in large volume nebulizer	up to 18 liters/month	Assignment on Formulary Products Only


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3. When a "concentrated form" of an inhalation drug is dispensed, separate saline solution (J7051 or A7019) 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 (J7051 or A7019) will be denied as not medically necessary. Water or saline in 1000 ml quantities (A7018 or A7020) are not appropriate for use by patients to dilute inhalation drugs and will therefore be denied as not medically necessary if used for this purpose. These codes are only medically necessary when used in a large volume nebulizer (A7017 or E0585).
4. Albuterol, bitolterol, epinephrine, isoetharine, isoproterenol, metaproterenol, and terbutaline are all bronchodilators with beta-adrenergic stimulatory effect. It would rarely be medically necessary for a patient to be using 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 medically necessary without documentation of medical necessity.
5. Ipratropium bromide, atropine, and glycopyrrolate are all anticholinergics. It would rarely be medically necessary for a patient to be using any 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 medically necessary without documentation of medical necessity.
6. Dornase alpha is covered for patients with cystic fibrosis (ICD-9 diagnosis 277.00).

Better living Now, Inc. assumes no responsibility in regards to Medicare coverage and has interpreted Medicare Rules for the benefit and understanding of the patient. For detailed information regarding Medicare coverage please visit their web site at: www.cms.gov. For Coverage Information for Respiratory Medications and Supplies go to: http://www.tricenturion.com/content/lmrp_current_dyn.cfm