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Respiratory Supplies Allowable Amounts
Better Living Now has developed preferred product relationships with industry leading manufacturers in an effort to bring you the highest quality products available that will be 100% covered by your insurance/Medicare plan with no additional out-of-pocket expense to you.
Contact us for more informationRespiratory Supplies Allowable Amounts - Effective 08/02/2011
Product Description
Allowable Amount
E0565
COMPRESSOR, AIR POWER SOURCE FOR EQUIPMENT WHICH IS NOT SELFCONTAINED OR CYLINDER DRIVEN
E0570 NEBULIZER, WITH COMPRESSOR
E0572
AEROSOL COMPRESSOR, ADJUSTABLE PRESSURE, LIGHT DUTY FOR INTERMITTENT USE
E0574
ULTRASONIC/ELECTRONIC AEROSOL GENERATOR WITH SMALL VOLUME NEBULIZER
E0575
NEBULIZER, ULTRASONIC, LARGE VOLUME
E0585 NEBULIZER, WITH COMPRESSOR AND HEATER
K0730 CONTROLLED DOSE INHALATION DRUG DELIVERY SYSTEM
A4619 FACE TENT
A7003
ADMINISTRATION SET, WITH SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER,DISPOSABLE
A7004
SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER, DISPOSABLE
A7005
ADMINISTRATION SET, WITH SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER,NON-DISPOSABLE
A7006
ADMINISTRATION SET, WITH SMALL VOLUME FILTERED PNEUMATIC NEBULIZER
A7007
LARGE VOLUME NEBULIZER, DISPOSABLE, UNFILLED, USED WITH AEROSOL COMPRESSOR
A7008
LARGE VOLUME NEBULIZER, DISPOSABLE, PREFILLED, USED WITH AEROSOL COMPRESSOR
A7009
RESERVOIR BOTTLE, NON-DISPOSABLE, USED WITH LARGE VOLUME ULTRASONIC NEBULIZER
A7010
CORRUGATED TUBING, DISPOSABLE, USED WITH LARGE VOLUME NEBULIZER, 100 FEET
A7011
CORRUGATED TUBING, NON-DISPOSABLE, USED WITH LARGE VOLUME NEBULIZER,10 FEET
A7012
WATER COLLECTION DEVICE, USED WITH LARGE VOLUME NEBULIZER
A7013
FILTER, DISPOSABLE, USED WITH AEROSOL COMPRESSOR OR ULTRASONIC GENERATOR
A7014
FILTER, NONDISPOSABLE, USED WITH AEROSOL COMPRESSOR OR ULTRASONIC GENERATOR
A7015 AEROSOL MASK, USED WITH DME NEBULIZER
A7016
DOME AND MOUTHPIECE, USED WITH SMALL VOLUME ULTRASONIC NEBULIZER
A7017
NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, NOT USED WITH OXYGEN
A7525 TRACHEOSTOMY MASK, EACH
E0580
NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, FOR USE WITH REGULATOR OR FLOWMETER
E1372 IMMERSION EXTERNAL HEATER FOR NEBULIZER
Notes - noneINHALATION DRUGS
Product Description
Allowable Amount
A4216
STERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, 10 ML
A4217 STERILE WATER/SALINE, 500 ML
A4218 STERILE SALINE OR WATER, METERED DOSE DISPENSER, 10 ML
G0333
PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); INITIAL 30-DAY SUPPLY AS A BENEFICIARY
J2545
PENTAMIDINE ISETHIONATE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MG
J7604
ACETYLCYSTEINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER GRAM
J7605
ARFORMOTEROL, INHALATION SOLUTION, FDA APPROVED FINAL PRODUCT, NONCOMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 15 MICROGRAMS
J7606
FORMOTEROL FUMARATE, INHALATION SOLUTION, FDA APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 20 MICROGRAMS
J7669
METAPROTERENOL SULFATE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS
J7670
METAPROTERENOL SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS
J7676
PENTAMIDINE ISETHIONATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MG
J7680
TERBUTALINE SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7681
TERBUTALINE SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7682
TOBRAMYCIN, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NONCOMPOUNDED, UNIT DOSE FORM, ADMINISTERED THROUGH DME, PER 300 MILLIGRAMS
J7683
TRIAMCINOLONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7684
TRIAMCINOLONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7685
TOBRAMYCIN, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MILLIGRAMS
J7686
TREPROSTINIL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NONCOMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 1.74 MG
J7699 NOC DRUGS, INHALATION SOLUTION ADMINISTERED THROUGH DME
Q0513
PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); PER 30 DAYS
Q0514
PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); PER 90 DAYS
Q4074
ILOPROST, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NONCOMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 20 MICROGRAMS
Notes - noneICD-9 Codes that Support Medical Necessity
The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on
"Indications and Limitations of Coverage and/or Medical Necessity" for other coverage criteria and payment information.
For HCPCS codes A4619, E0565, E0572:
Product Description
Allowable Amount
011.50 - 011.56
TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER
METHODS (INOCULATION OF ANIMALS)
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
136.3 PNEUMOCYSTOSIS
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS
494.0 BRONCHIECTASIS WITHOUT ACUTE EXACERBATION
494.1 BRONCHIECTASIS WITH ACUTE EXACERBATION
519.19 OTHER DISEASES OF TRACHEA AND BRONCHUS
748.61 CONGENITAL BRONCHIECTASIS
996.80 - 996.89
COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN
V44.0 TRACHEOSTOMY STATUS
V55.0 ATTENTION TO TRACHEOSTOMY
Notes - noneFor HCPCS codes A7015, A7525:
Product Description
Allowable Amount
011.50 - 011.56
TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
136.3 PNEUMOCYSTOSIS
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS
480.0 - 508.9
PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT
519.19 OTHER DISEASES OF TRACHEA AND BRONCHUS
748.61 CONGENITAL BRONCHIECTASIS
786.4 ABNORMAL SPUTUM
996.80 - 996.89
COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN
V44.0 TRACHEOSTOMY STATUS
V55.0 ATTENTION TO TRACHEOSTOMY
Notes - noneFor HCPCS codes A7003, A7004, E0570:
Product Description
Allowable Amount
011.50 - 011.56
TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
136.3 PNEUMOCYSTOSIS
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS
480.0 - 508.9
PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT
748.61 CONGENITAL BRONCHIECTASIS
786.4 ABNORMAL SPUTUM
996.80 - 996.89
COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN
Notes - noneFor HCPCS codes A7006, J2545:
Product Description
Allowable Amount
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
136.3 PNEUMOCYSTOSIS
996.80 - 996.89
COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN
011.50 - 011.56
TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS
494.0 BRONCHIECTASIS WITHOUT ACUTE EXACERBATION
494.1
BRONCHIECTASIS WITH ACUTE EXACERBATION
519.19
OTHER DISEASES OF TRACHEA AND BRONCHUS
748.61 CONGENITAL BRONCHIECTASIS
V44.0 TRACHEOSTOMY STATUS
V55.0 ATTENTION TO TRACHEOSTOMY
Notes - noneFor HCPCS code A4216:
Product Description
Allowable Amount
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
136.3 PNEUMOCYSTOSIS
491.0 - 508.9
SIMPLE CHRONIC BRONCHITIS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT
996.80 - 996.89
COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN
Notes - noneFor HCPCS codes J7608:
Product Description
Allowable Amount
480.0 - 508.9
PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT
491.0 - 508.9
SIMPLE CHRONIC BRONCHITIS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT
Notes - noneFor HCPCS code J7639:
Product Description
Allowable Amount
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS
Notes - noneFor HCPCS code J7682:
Product Description
Allowable Amount
011.50 - 011.56
TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS
011.50 - 011.56
TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
136.3 PNEUMOCYSTOSIS
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS
416.0 PRIMARY PULMONARY HYPERTENSION
416.8 OTHER CHRONIC PULMONARY HEART DISEASES
480.0 - 508.9
PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT
748.61 CONGENITAL BRONCHIECTASIS
786.4 ABNORMAL SPUTUM
996.80 - 996.89
COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN
Notes - noneFor HCPCS codes A7013, A7014:
Product Description
Allowable Amount
011.50 - 011.56
TUBERCULOUS BRONCHIECTASIS UNSPECIFIED EXAMINATION - TUBERCULOUS BRONCHIECTASIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)
042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE
136.3 PNEUMOCYSTOSIS
277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS
416.0 PRIMARY PULMONARY HYPERTENSION
416.8 OTHER CHRONIC PULMONARY HEART DISEASES
480.0 - 508.9
PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT
519.19 OTHER DISEASES OF TRACHEA AND BRONCHUS
748.61 CONGENITAL BRONCHIECTASIS
786.4 ABNORMAL SPUTUM
996.80 - 996.89
COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN
V44.0 TRACHEOSTOMY STATUS
V55.0 ATTENTION TO TRACHEOSTOMY
Notes
Diagnoses that Support Medical Necessity
Refer to the previous section for the specific HCPCS code indicated. For all other HCPCS codes listed in the policy refer
to the section on "Indications and Limitations of Coverage and/or Medical Necessity" for other criteria and payment
information.
ICD-9 Codes that DO NOT Support Medical Necessity
For the specific HCPCS codes indicated above, all ICD-9 codes that are not specified in the previous section.
For HCPCS codes A7009, E0575, 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, and J7685, all ICD-9 codes.
For all other HCPCS codes, ICD-9 codes are not specified.
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
For the specific HCPCS codes indicated above, all diagnoses that are not specified in the previous section.
For HCPCS codes A7009, E0575, 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, and J7685, all diagnoses.
For all other HCPCS codes, diagnoses are not specified.
Respiratory Supplies Guidelines
General InformationFor more information on local coverage determination Local Coverage Determination (LCD) for Respiratory SuppliesIndications and Limitations of Coverage and/or Medical Necessity
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 local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act §
1862(a)(1)(A) provisions, 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 reasonable and necessary.
A small volume nebulizer (A7003, A7004, A7005), related compressor (E0570), and FDA-approved inhalation solutions
of the drugs listed below are covered when:
a. It is reasonable and necessary to administer albuterol (J7611, J7613), arformoterol (J7605), budesonide (J7626),
cromolyn (J7631), formoterol (J7606), ipratropium (J7644), levalbuterol (J7612, J7614), or metaproterenol
(J7669) for the management of obstructive pulmonary disease (ICD-9 diagnosis codes 491.0-508.9); or
b. It is reasonable and necessary to administer dornase alpha (J7639) to a patient with cystic fibrosis (ICD-9
diagnosis code 277.02); or
c. It is reasonable and necessary to administer tobramycin (J7682) to a patient with cystic fibrosis or bronchiectasis
(ICD-9 diagnosis code 277.02, 494.0, 494.1, 748.61, 011.50-011.56); or
d. It is reasonable and necessary to administer pentamidine (J2545) to a patient with HIV (ICD-9 diagnosis code
042), pneumocystosis (ICD-9 diagnosis code 136.3), or complications of organ transplants (ICD-9 diagnosis
codes 996.80-996.89); or
e. It is reasonable and necessary to administer acetylcysteine (J7608) for persistent thick or tenacious pulmonary
secretions (ICD-9 diagnosis codes 480.0-508.9, 786.4).
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 covered when it is reasonable and necessary to deliver humidity to a patient with thick, tenacious secretions, who
has cystic fibrosis (ICD-9 diagnosis code 277.02), bronchiectasis (ICD-9 diagnosis code 494.0, 494.1, 011.50-011.56 or
748.61), a tracheostomy (ICD-9 diagnosis code V44.0 or V55.0), or a tracheobronchial stent (ICD-9 diagnosis code
519.19). Combination code E0585 will be covered for the same indications.
An E0565 or E0572 compressor and filtered nebulizer (A7006) are also covered when it is reasonable and necessary to
administer pentamidine to patients with HIV (ICD-9 diagnosis code 042), pneumocystosis (ICD-9 diagnosis code 136.3)
or complications of organ transplants (ICD-9 diagnosis codes 996.80-996.89).
A small volume ultrasonic nebulizer (E0574) and related accessories are reasonable and necessary to administer
treprostinil inhalation solution only. Claims for code E0574 used with other inhalation solutions will be denied as not
reasonable and necessary.
Treprostinil inhalation solution (J7686) and iloprost (Q4074) are covered when all of the following criteria 1-3 are met:
1. The patient has a diagnosis of pulmonary artery hypertension (ICD-9 diagnosis codes 416.0 or 416.8); 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, 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
3. 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, anorexigens or congenital left to right shunts. If these
conditions are present, the following criteria (a-d) 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 > 25 mm Hg at rest or > 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.
If the above criteria are not met, code E0574 and the related drug (J7686 for treprostinil) or code K0730 and the related
drug (Q4074 for iloprost) will be denied as not reasonable and necessary.
A controlled dose inhalation drug delivery system (K0730) is covered when it is reasonable and necessary to deliver
iloprost (Q4074) to patients with pulmonary hypertension (ICD-9 diagnosis codes 416.0 or 416.8) only. Claims for code
K0730 for use with other inhalation solutions 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 medically unnecessary.
Notes
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
A7011
One/year
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
Notes - noneINHALATION 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 alpha
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
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
Notes - noneWhen albuterol, levalbuterol, or metaproterenol are prescribed as rescue/supplemental medication for patients 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/Ipratropium combination
31 units/month
Levalbuterol
39 mg/month (78 units/month)
Metaproterenol
470 mg/month (47 units/month)
Notes
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 patients 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 patient 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 patient 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.
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-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. Physicians may submit a claim for drugs if all of the following conditions are met: the physician is 1)
enrolled as a 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 physician’s license. Claims submitted by
entities not licensed to dispense drugs will be denied for lack of medical necessity.Documentations Requirements
Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there
has been furnished such information as may be necessary in order to determine the amounts due such
provider." It is expected that the patient's medical records will reflect the need for the care provided. The
patient's medical records include the physician's office records, hospital records, nursing home records,
home health agency records, records from other healthcare professionals and test reports. This
documentation must be available upon request.
An order for each item billed must be signed and dated by the treating physician, kept on file by the
supplier, and made available upon request. Items billed before a signed and dated order has been
received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.
The order for any drug must clearly specify the type of solution to be dispensed to the patient and the
administration instructions for that solution. The type of solution is described by a combination of (a) the
name of the drug and the concentration of the drug in the dispensed solution and the volume of solution
in each container, or (b) the name of the drug and the number of milligrams/grams of drug in the
dispensed solution and the volume of solution in that container. Examples of (a) would be: albuterol
0.083% 3 ml; or albuterol 0.5% 20 ml; or cromolyn 20 mg/2 ml. An example of (b) is: albuterol 1.25 mg
in 3 ml saline. For compounded inhalation solutions, the order must include the following statement prior
to signature by the physician: compounded inhalation solution - not FDA-approved.
Administration instructions must specify the amount of solution and specific frequency of use. As noted in
the Program Integrity Manual (Internet-Only Manual, Pub. 100-8), Chapter 5, Section 5.9 "...do not
accept 'PRN' or 'as needed' utilization estimates for supply replacement, use, or consumption." For orders
that include "PRN" or "as needed", reimbursement will be based on the specified frequency of use on the
order only.
REFILLS:
A routine refill prescription is not needed. A new prescription is needed when:
• There is a change of supplier
• There is a change in treating physician
• There is a change in the item(s), frequency of use, or amount prescribed
• There is a change in the length of need or a previously established length of need expires
• State law requires periodic prescription renewal
For items that the patient obtains in person at a retail store, the signed delivery slip or copy of itemized
sales receipt is sufficient documentation of a request for refill.
For items that are delivered to the beneficiary, documentation of a request for refill must be either a
written document received from the beneficiary or a contemporaneous written record of a phone
conversation/contact between the supplier and beneficiary. The refill request must occur and be
documented before shipment. A retrospective attestation statement by the supplier or beneficiary is not
sufficient. The refill record must include:
• Beneficiary's name or authorized representative if different than the beneficiary
• A description of each item that is being requested
• Date of refill request
• Quantity of each item that the beneficiary still has remaining
This information must be kept on file and be available upon request.
An ICD-9 code describing the condition which necessitates nebulizer therapy must be included on each
claim for equipment, accessories, and/or drugs.
KX, GA, AND GZ MODIFIERS:
Suppliers must add a KX modifier to codes for E0574,J7686, K0730 and Q4074 only if all of the criteria in
the Indications and Limitations of Coverage and/or Medical Necessity section of this policy have been
met.
If all of the criteria in the Indications and Limitations of Coverage and/or Medical Necessity section have
not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a
medical necessity denial, suppliers must enter GA on the claim line if they have obtained a properly
executed Advance Beneficiary Notice (ABN) or GZ if they have not obtained a valid ABN.
Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.
MISCELLANEOUS
When code E1399 is billed for miscellaneous equipment or accessories, the claim must be accompanied
by a clear description of the item including the manufacturer and the model name/number if applicable.
When Not Otherwise Classified (NOC) drug code J7699 is billed for miscellaneous inhalation drugs, the
claim must be accompanied by the detailed order information described above and a clear statement of
the number of ampules/bottles of solution dispensed.
Refer to the Supplier Manual for more information on documentation requirements.
Refills
For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective
use. For DMEPOS products (A4619, A7003-A7017, A7525, all inhalation medications) that are supplied as refills to the
original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a predetermined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains
reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes/modifications to
the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days
prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than
10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.
(CMS’ Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.6).
For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary
or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request
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 ordering
physicians 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.
For more information on local coverage determination Local Coverage Determination (LCD) for Respiratory Supplies
