LCD/NCD Portal

L5007

 

NEBULIZERS

 

Region IV

DME

Jurisdiction C

 

08/05/2011

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• For any item to be covered by Medicare, it must

o Be eligible for a defined Medicare benefit category.

o Be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

o Meet all other applicable Medicare statutory and regulatory requirements.

o 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.

o 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:

o 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

o It is reasonable and necessary to administer dornase alpha (J7639) to a patient with cystic fibrosis (ICD-9 diagnosis code 277.02); or

o 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

o 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

o 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:

o The patient has a diagnosis of pulmonary artery hypertension (ICD-9 diagnosis codes 416.0 or 416.8); and,

o 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,

o 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:

o The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and,

o The mean pulmonary artery pressure is > 25 mm Hg at rest or > 30 mm Hg with exertion; and,

o The patient has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and,

o 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:

 

o Accessories are separately payable if the related aerosol compressor and the individual accessories are reasonable and necessary.

o The following table lists the compressor/generator, which is related to the accessories described.

o Other compressor/generator/accessory combinations are considered not reasonable and necessary.

 

 

Compressor/Generator  Related Accessories

 

E0565  A4619, A7006, A7007, A7010, A7011, A7012, A7013, A7014, A7015, A7017, A7525, E1372

E0570  A7003, A7004, A7005, A7006, A7013, A7015, A7525

E0572  A7006, A7014

E0574  A7013, A7014, A7016

E0585  A4619, A7006, A7010, A7011, 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

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

 

 

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 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

 

• When 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/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.

o Saline dispensed for the dilution of concentrated nebulizer drugs must be billed on the same claim as the drug(s) being diluted.

o 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.

o 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.

o 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.

o 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.

o It is not reasonable and necessary for a patient to use more than one of these at a time.

o 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.

o The medical necessity for administering additional albuterol sulfate (J7611, J7613), levalbuterol (J7612, J7614) and/or ipratropium bromide (J7644) has not been established.

o 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.

o Only entities licensed in the state where they are physically located may submit a claim for nebulizer drugs.

o Physicians may submit a claim for drugs if all of the following conditions are met: the physician is

 enrolled as a DMEPOS supplier with the National Supplier Clearinghouse

 dispensing the drug(s) to the Medicare beneficiary

 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.

 

 

• REFILL REQUIREMENTS

 

o 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 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 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).

o 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.

o 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.

 

 

Coding Information

 

Bill Type Codes:

 

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

 

Revenue Codes:

 

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

CPT/HCPCS Codes

 

• The appearance of a code in this section does not necessarily indicate coverage.

 

 

HCPCS MODIFIERS:

 

• EY - No physician or other licensed health care provider order for this item or service

 

• GA - Waiver of liability statement issued as required by payer policy, individual case

 

• GZ - Item or service expected to be denied as not reasonable and necessary

 

• KO - Single drug unit dose formulation.

 

• KP - First drug of a multiple drug unit dose formulation

 

• KQ - Second or subsequent drug of a multiple drug unit dose formulation.

 

• KX - Requirements specified in the medical policy have been met

 

 

HCPCS CODES:

 

EQUIPMENT

 

E0565 COMPRESSOR, AIR POWER SOURCE FOR EQUIPMENT WHICH IS NOT SELF- CONTAINED 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

 

 

ACCESSORIES

 

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

 

 

INHALATION DRUGS

 

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, NON-COMPOUNDED, 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

J7607 LEVALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 0.5 MG

J7608 ACETYLCYSTEINE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER GRAM

J7609 ALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE, 1 MG

J7610 ALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 1 MG

J7611 ALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 1 MG

J7612 LEVALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 0.5 MG

J7613 ALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE, 1 MG

J7614 LEVALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE, 0.5 MG

J7615 LEVALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE, 0.5 MG

J7620 ALBUTEROL, UP TO 2.5 MG AND IPRATROPIUM BROMIDE, UP TO 0.5 MG, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME

J7622 BECLOMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7624 BETAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7626 BUDESONIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 0.5 MG

J7627 BUDESONIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 0.5 MG

J7628 BITOLTEROL MESYLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7629 BITOLTEROL MESYLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7631 CROMOLYN SODIUM, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS

J7632 CROMOLYN SODIUM, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS

J7634 BUDESONIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER 0.25 MILLIGRAM

J7635 ATROPINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7636 ATROPINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7637 DEXAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7638 DEXAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7639 DORNASE ALFA, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7640 FORMOTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 12 MICROGRAMS

J7641 FLUNISOLIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE, PER MILLIGRAM

J7642 GLYCOPYRROLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7643 GLYCOPYRROLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7644 IPRATROPIUM BROMIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7645 IPRATROPIUM BROMIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7647 ISOETHARINE HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7650 ISOETHARINE HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7657 ISOPROTERENOL HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM

J7660 ISOPROTERENOL HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM

J7667 METAPROTERENOL SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, CONCENTRATED FORM, PER 10 MILLIGRAMS

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, NON-COMPOUNDED, 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, NON-COMPOUNDED, 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, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 20 MICROGRAMS

 

 

ICD-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, and E0572:

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

 

 

For HCPCS codes A7015, A7525:

 

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

 

 

For HCPCS codes A7003, A7004, E0570:

 

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

 

 

For HCPCS codes A7006, J2545:

 

042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

136.3 PNEUMOCYSTOSIS

996.80 - 996.89

COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN

 

 

For HCPCS codes A4217, A7007, A7010, A7011, A7012, A7017, A7018, E0585, E1372:

 

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

 

 

For HCPCS code A4216:

 

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

 

 

For HCPCS code J7608:

 

480.0 - 508.9

PNEUMONIA DUE TO ADENOVIRUS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT

786.4 ABNORMAL SPUTUM

 

 

For HCPCS codes J7605, J7606, J7611, J7612, J7613, J7614 J7620, J7626, J7631, J7644, J7669:

 

491.0 - 508.9 SIMPLE CHRONIC BRONCHITIS - RESPIRATORY CONDITIONS DUE TO UNSPECIFIED EXTERNAL AGENT

 

 

For HCPCS code J7639:

 

277.02 CYSTIC FIBROSIS WITH PULMONARY MANIFESTATIONS

 

 

For HCPCS code J7682:

 

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

748.61 CONGENITAL BRONCHIECTASIS

 

 

For HCPCS codes A7016, E0574, J7686, K0730, Q4074:

 

416.0 PRIMARY PULMONARY HYPERTENSION

416.8 OTHER CHRONIC PULMONARY HEART DISEASES

 

 

For HCPCS code A7005:

 

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

 

 

For HCPCS code A7013, A7014:

 

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

 

 

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.

 

 

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".

o It is expected that the patient's medical records will reflect the need for the care provided.

o 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.

o 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.

o 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.

o The type of solution is described by a combination of

 the name of the drug and the concentration of the drug in the dispensed solution and the volume of solution in each container, or

 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.

o An example of (b) is: albuterol 1.25 mg in 3 ml saline.

o 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.

o 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.”

o For orders that include “PRN” or “as needed”, reimbursement will be based on the specified frequency of use on the order only.

 

 

• REFILLS

 

o 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 a renewal

o 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.

o 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

o This information must be kept on file and be available upon request.

o 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:

o 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.

o 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.

o Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.

 

 

• MISCELLANEOUS

o 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.

o 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.

o Refer to the Supplier Manual for more information on documentation requirements.

 

Sources of Information and Basis for Decision

 

A24623 - Nebulizers - Policy Article - Effective - August 2011

 

Local Coverage Determination (LCD) for Nebulizers (L5007)