Tuesday, April 11, 2017

Nebuilzers CPT code list


CPT/HCPCS Codes

Group 1 Paragraph: 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

JW - Drug amount discarded/not administered to any patient

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


Group 1 Codes:

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


Group 2 Paragraph: ACCESSORIES

Group 2 Codes:

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

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


Coverage Guidance


Coverage Indications, Limitations, 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 coverage indications, limitations and/or medical necessity.

Medicare does not automatically assume payment for a Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) item that was covered prior to a beneficiary becoming eligible for the Medicare Fee for Service (FFS) program. When a beneficiary receiving a DMEPOS item from another payer (including Medicare Advantage plans) becomes eligible for the Medicare FFS program, Medicare will pay for continued use of the DMEPOS item only if all Medicare coverage, coding and documentation requirements are met. Additional documentation to support that the item is reasonable and necessary, may be required upon request of the DME MAC.

While this Standard Documentation language makes reference to “ACA 6407 requirements”, technically these requirements are found in the Social Security Act Section 1843(a)(11)(B) and its implementing regulation at 42 CFR 410.38. The CMS regulation contains the details for the face-to-face examination, written order prior to delivery and the list of items subject to these requirements.

For an item to be covered by Medicare, a detailed written order (DWO) 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 DWO, the item will be denied as not reasonable and necessary.

For some items in this policy to be covered by Medicare, a written order prior to delivery (WOPD) is required. Refer to the DOCUMENTATION REQUIREMENTS section of this LCD and to the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the related Policy Article for information about WOPD prescription requirements.

For some items in this policy to be covered by Medicare, a written order is required to be in the supplier’s file prior to delivery of the specified item(s). There are two differing order requirements that may apply depending upon the specific item prescribed:
The Affordable Care Act Section 6407 (ACA 6407) specifies the five elements that must be contained in this written order. For purposes of this policy, this order is termed the 5-element order (5EO).

A written order prior to delivery (WOPD) that meets all of the requirements of a standard detailed written order (DWO).
If the supplier delivers an item addressed in this policy without first receiving the completed order, the item will be denied. Refer to the DOCUMENTATION REQUIREMENTS section of this LCD and/or to the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the related Policy Article for information about these prescription requirements and the type of denial that will result from non-compliance.

A small volume nebulizer (A7003, A7004, A7005), related compressor (E0570) and FDA-approved inhalation solutions of the drugs listed below are covered when:
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 (Reference the Diagnosis Codes that Support Medical Necessity Group 8 Codes section for applicable diagnoses); or

It is reasonable and necessary to administer dornase alpha (J7639) to a beneficiary with cystic fibrosis (Reference the Diagnosis Codes that Support Medical Necessity Group 9 Codes section for applicable diagnoses); or

It is reasonable and necessary to administer tobramycin (J7682) to a beneficiary with cystic fibrosis or bronchiectasis (Reference the Diagnosis Codes that Support Medical Necessity Group 10 Codes section for applicable diagnoses); or

It is reasonable and necessary to administer pentamidine (J2545) to a beneficiary with HIV, pneumocystosis, or complications of organ transplants (Reference the Diagnosis Codes that Support Medical Necessity Group 4 Codes section for applicable diagnoses); or

It is reasonable and necessary to administer acetylcysteine (J7608) for persistent thick or tenacious pulmonary secretions (Reference the Diagnosis Codes that Support Medical Necessity Group 7 Codes section 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 covered 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 (Reference the Diagnosis Codes that Support Medical Necessity Group 5 Codes section for applicable diagnoses). 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 beneficiaries with HIV, pneumocystosis, or complications of organ transplants (Reference the Diagnosis Codes that Support Medical Necessity Group 1 Codes section for applicable diagnoses).

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:
The beneficiary has a diagnosis of pulmonary artery hypertension (Reference the Diagnosis Codes that Support Medical Necessity Group 11 Codes section for applicable diagnoses); and

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

The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, thromboembolic disease of the pulmonary arteries, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present, the following criteria (a-d) must be met:
The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and

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

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

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 beneficiaries with pulmonary hypertension only (Reference the Diagnosis Codes that Support Medical Necessity Group 11 Codes section for applicable diagnoses). 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 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 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 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.

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.

Effective January 1, 2017, if the coverage criteria for the nebulizer drug are not met, claims billed for drug wastage with the JW modifier will 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 (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. 100-08, Chapter 5, Section 5.2.8).

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 prescribing 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.



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.
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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.

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