Article - Nebulizers - Policy Article (A52466)

Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.CODING GUIDELINESEQUIPMENT:In this policy, nebulization of inhalation solutions is accomplished by two types of devices. Pneumatic compressor nebulizers achieve nebulization of liquid by means of air flow. Ultrasonic or electronic nebulizers produce nebulization of liquid by means of a vibrating mechanism.HCPCS code E0565 describes an aerosol compressor, which can be set for pressures above 30 psi at a flow of 6-8 L/m and is capable of continuous operation.A nebulizer with compressor (E0570) is an aerosol compressor, which delivers a fixed, low pressure and is used with a small volume nebulizer. It may be AC-powered, DC-powered or both.A light duty adjustable pressure compressor (E0572) is a pneumatic aerosol compressor which can be set for pressures above 30 psi at a flow of 6-8 L/m, but is capable only of intermittent operation.HCPCS code E0574 describes an ultrasonic/electronic generator used with a small volume chamber for medication delivery. Aerosolization of the inhalation solution occurs in a nebulization chamber by means of a vibrating mechanism such as (not all inclusive) a vibrating disk, pizo-electric device or vibrating mesh.Accessories used in conjunction with ultrasonic nebulizers coded E0574 should be billed on separate claim lines. The dome and mouthpiece should be billed with code A7016. Other accessories should be billed with code A9999. When code A9999 is used, the claim must clearly describe the type and quantity of accessories provided.For dates of service on or after April 1, 2011, products coded E0574 must have received coding verification review (CVR) from the Pricing, Data Analysis and Coding (PDAC) contractor. The only products that may be billed using code E0574 are those that are specified in the Product Classification List (PCL) on the PDAC contractor web site.If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.HCPCS code E0575 describes a large volume ultrasonic nebulizer system which is used for medication and humidification delivery, and which is capable of continuous operation.HCPCS code K0730 describes a controlled dose inhalation drug delivery system. Aerosol is delivered in pulses during the inspiration. The duration of each pulse is adapted according to the breathing pattern.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following nebulizers and related accessories HCPCS codes for individual items are included in the functionality of code E0467:HCPCS codes E0565, E0570, E0572, E0585, A4619, A7003, A7004, A7005, A7006, A7007, A7012, A7013, A7014, A7015, A7017, A7525, and E1372For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by the HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) contractor for guidance on the correct coding of these items.ACCESSORIES:HCPCS codes A7003, A7005, and A7006 include the lid, jar, baffles, tubing, T-piece and mouthpiece. In addition, code A7006 includes a filter.HCPCS code A7004 includes only the lid, jar and baffles.HCPCS code A7012 describes a device to collect water condensation, which is placed in line with the corrugated tubing, used with a large volume nebulizer.HCPCS code A7016 describes the dome and mouthpiece containing the aerosolization mechanism for an ultrasonic/electronic nebulizer system.HCPCS code E0585 is used when a heavy-duty aerosol compressor (E0565), durable bottle type large volume nebulizer (A7017), and immersion heater (E1372) are provided at the same time. If all three items are not provided initially, the separate codes for the components would be used for billing. Code A7007 or A7017 is billed when an unfilled large volume nebulizer is used with an E0572 compressor or a separately billed E0565 compressor. Code A7007 or A7017 would not be separately billed when an E0585 system was also being billed. Code E0580 (Nebulizer, durable, glass or autoclavable plastic, bottle type, for use with regulator or flow meter) describes the same piece of equipment as A7017, but should only be billed when this type of nebulizer is used with a beneficiary-owned oxygen system.INHALATION DRUGS:The following instructions apply to claims billed using J codes. When claims are billed in NCPDP format using NDC numbers, different instructions may apply. Refer to the NCPDP Companion Document available through the CMS website.A compounded inhalation solution is one in which the product that is delivered to the beneficiary is not an FDA-approved preparation. It is produced by a pharmacy that is not an FDA-approved manufacturer and involves the mixing, combining, or altering of ingredients for an individual beneficiary. Even if one the ingredients is an FDA-approved product (e.g., an injectable form of the drug), if that is mixed by the pharmacy with other ingredients, the solution that is dispensed to the beneficiary is considered to be a compounded product.There are distinct codes for FDA-approved final products and for compounded final products. The appropriate code must be used when a claim is submitted. Code J7999 (COMPOUNDED DRUG, NOT OTHERWISE CLASSIFIED) does not apply to compounded nebulizer drugs and must not be used. Claims for compounded nebulizer drugs using J7999 will be denied as incorrect coding.HCPCS codes J2545 (pentamidine), J7608 (acetylcysteine), J7631 (cromolyn), J7639 (dornase alfa) and Q4074 (iloprost) may only be used for inhalation solutions which are FDA-approved. If compounded versions of these drugs are provided, they must be billed using code J7699.There are no FDA-approved final products that are described by the following codes: J7633 (budesonide, concentrate), J7648 (isoetharine, concentrate), J7649 (isoetharine, unit dose), J7658 (isoproterenol, concentrate), J7659 (isoproterenol, unit dose), and J7668 (metaproterenol, concentrate). These codes are invalid for claim submission.HCPCS codes J7602 (Albuterol, all formulations including separated isomers, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, per 1 mg (albuterol) or per 0.5 mg (levalbuterol)) and J7603 (Albuterol, all formulations including separated isomers, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose, per 1 mg (albuterol) or per 0.5 mg (levalbuterol)) were effective for claims with dates of service from 1/1/2008  3/31/2008. They are invalid for claim submission for dates of service on or after 4/1/2008.Unit dose form of an inhalation drug or a combination of drugs is one in which the medication is dispensed to a beneficiary (1) in a bottle/vial/ampule which contains the dose usually used for a single inhalation treatment, and (2) in a concentration which is dilute enough that it may be administered to a beneficiary without adding any separate diluent.Concentrated form of a drug used for inhalation is one in which the drug is dispensed to a beneficiary in a concentration which requires that a separate diluent (usually saline) be added to the nebulizer when the drug is administered to a beneficiary.The coding of a unit dose form or a concentrated form of an inhalation drug is determined by the formulation of the drug as it is dispensed to the beneficiary. For example, if a pharmacist takes a concentrated form of a single inhalation drug (e.g., 0.5% albuterol) and dilutes it to a ready-to-use concentration (e.g., 0.083% albuterol), which is then dispensed to the beneficiary in a single-dose bottles/vials/ampules, the inhalation solution is billed as the compounded unit dose form, not the concentrated form.When there is a single drug in a unit dose container, the KO modifier is added to the unit dose form code. (Exception: The KO modifier is not used with code J2545 or Q4074.)Except for code J7620, when two or more drugs are combined and dispensed to the beneficiary in the same unit dose container, each of the drugs is billed using its unit dose form code. The KP modifier is added to only one of the unit dose form codes and the KQ modifier is added to the other unit dose code(s).Whenever a unit dose form code is billed, it must have a KO, KP or KQ modifier. (Exception: The KO, KP and KQ modifiers should not be used with code J7620.) If a unit dose code does not have one of these modifiers, it will be denied as an invalid code. The KO, KP, and KQ modifiers are not used with the concentrated form codes.The only FDA-approved unit dose preparation containing more than one drug is J7620, the combination of albuterol and ipratropium. Therefore, if the following FDA-approved unit dose codes are billed with a KP or KQ modifier, they will be rejected as invalid for claim submission: J7605, J7606, J2545, J7608, J7613, J7614, J7626, J7631, J7639, J7644, J7669, J7682, J7686, and Q4074.The billing unit of service for inhalation drug codes varies. Suppliers must be sure that they use the correct billing unit or the code when calculating the number of units of service to enter on the claim. The following is guidance on a few codes where errors are commonly seen: