Nebulizers – Medicare Advantage Policy Guideline

UnitedHealthcare? Medicare Advantage Policy Guideline

Nebulizers

Guideline Number: MPG211.07 Approval Date: June 8, 2022

Terms and Conditions

Table of Contents

Page

Policy Summary ............................................................................. 1

Applicable Codes .......................................................................... 2

Definitions ...................................................................................... 5

Questions and Answers ................................................................ 6

References ..................................................................................... 6

Guideline History/Revision Information ....................................... 7

Purpose .......................................................................................... 7

Terms and Conditions ................................................................... 8

Related Medicare Advantage Policy Guidelines ? Home Use of Oxygen ? KX Modifier

Related Medicare Advantage Coverage Summary ? Durable Medical Equipment (DME), Prosthetics,

Corrective Appliances/Orthotics (Non-Foot Orthotics), Nutritional Therapy and Medical Supplies Grid

Policy Summary

Overview

Nebulizers can be covered if the member's ability to breathe is severely impaired.

See Purpose

Lung diseases such as chronic obstructive pulmonary disease (COPD) and asthma are characterized by airflow limitation that may be partially or completely reversible. Pharmacologic treatment with bronchodilators is used to prevent and/or control daily symptoms that may cause disability for persons with these diseases. These medications are intended to improve the movement of air into and from the lungs by relaxing and dilating the bronchial passageways. Beta adrenergic agonists are a commonly prescribed class of bronchodilator drug. They can be administered via nebulizer, metered dose inhaler, orally, or dry powdered inhaler.

Guidelines

For a DME 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. The "reasonable and necessary" criteria, based on Social Security Act ?1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

A diagnosis code describing the condition which necessitates nebulizer therapy must be included on each claim for equipment, accessories, and/or drugs.

Nebulizers require a face-to-face encounter and a Written Order Prior to Delivery (WOPD).

Documentation Requirements - General

There are numerous CMS manual requirements, reasonable and necessary requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Refer to the LCD, NCD or other CMS Manuals for more information on what documents may be required.

Nebulizers

Page 1 of 8

UnitedHealthcare Medicare Advantage Policy Guideline

Approved 06/08/2022

Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.

See Article A55426 Standard Documentation Requirements for All Claims Submitted to DME MACs.

Applicable Codes

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

Coding Clarifications: *Compounded inhalation solutions will be denied as not reasonable and necessary. **There are no FDA-approved final products for these drugs hence the codes are invalid for claim submission.

HCPCS Code A7003 A7004 A7005 A7006 A7007 A7008 A7009 A7010 A7012 A7013 A7014 A7015 A7016 A7017 A7018 E0565 E0570 E0572 E0574 E0575 E0585 E1372 G0333 J2545

J7604*

J7605

J7606

Description Administration set, with small volume nonfiltered pneumatic nebulizer, disposable Small volume nonfiltered pneumatic nebulizer, disposable Administration set, with small volume nonfiltered pneumatic nebulizer, non-disposable Administration set, with small volume filtered pneumatic nebulizer Large volume nebulizer, disposable, unfilled, used with aerosol compressor Large volume nebulizer, disposable, prefilled, used with aerosol compressor (Non-covered) Reservoir bottle, non-disposable, used w/ large volume ultrasonic nebulizer (Non-covered) Corrugated tubing, disposable, used with large volume nebulizer, 100 feet Water collection device, used with large volume nebulizer Filter, disposable, used with aerosol compressor or ultrasonic generator Filter, non-disposable, used with aerosol compressor or ultrasonic generator Aerosol mask, used with DME nebulizer Dome and mouthpiece, used with small volume ultrasonic nebulizer Nebulizer, durable, glass or autoclavable plastic, bottle type, not used with oxygen Water, distilled, used with large volume nebulizer, 1000 ml Compressor, air power source for equipment which is not self- contained or cylinder driven Nebulizer, with compressor Aerosol compressor, adjustable pressure, light duty for intermittent use Ultrasonic/electronic aerosol generator with small volume nebulizer Nebulizer, ultrasonic, large volume (Non-covered) Nebulizer, with compressor and heater Immersion external heater for nebulizer Pharmacy dispensing fee for inhalation drug(s); initial 30-day supply as a beneficiary Pentamidine isethionate, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per 300 mg Acetylcysteine, inhalation solution, compounded product, administered through DME, unit dose form, per gram Arformoterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, 15 micrograms Formoterol fumarate, inhalation solution, FDA approved final product, non-compounded, administered through DME, unit dose form, 20 micrograms

Nebulizers

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HCPCS Code J7607* J7608 J7609* J7610* J7611 J7612 J7613 J7614 J7615* J7620 J7622* J7624* J7626 J7627* J7628* J7629* J7631 J7632* J7633** J7634* J7635* J7636* J7637* J7638* J7639

Description Levalbuterol, inhalation solution, compounded product, administered through DME, concentrated form, 0.5 mg

Acetylcysteine, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per gram

Albuterol, inhalation solution, compounded product, administered through DME, unit dose, 1 mg

Albuterol, inhalation solution, compounded product, administered through DME, concentrated form, 1 mg

Albuterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, 1 mg

Levalbuterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, 0.5 mg

Albuterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose, 1 mg

Levalbuterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose, 0.5 mg

Levalbuterol, inhalation solution, compounded product, administered through DME, unit dose, 0.5 mg

Albuterol, up to 2.5 mg and ipratropium bromide, up to 0.5 mg, FDA-approved final product, noncompounded, administered through DME

Beclomethasone, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Betamethasone, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Budesonide, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, up to 0.5 mg

Budesonide, inhalation solution, compounded product, administered through DME, unit dose form, up to 0.5 mg

Bitolterol mesylate, inhalation solution, compounded product, administered through DME, concentrated form, per milligram

Bitolterol mesylate, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Cromolyn sodium, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per 10 milligrams

Cromolyn sodium, inhalation solution, compounded product, administered through DME, unit dose form, per 10 milligrams

Budesonide, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, per 0.25 mg

Budesonide, inhalation solution, compounded product, administered through DME, concentrated form, per 0.25 milligram

Atropine, inhalation solution, compounded product, administered through DME, concentrated form, per milligram

Atropine, inhalation solution, compounded product, administered through DME, unit dose form, per mg

Dexamethasone, inhalation solution, compounded product, administered through DME, concentrated form, per milligram

Dexamethasone, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Dornase alfa, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per milligram

Nebulizers

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UnitedHealthcare Medicare Advantage Policy Guideline

Approved 06/08/2022

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HCPCS Code J7640* J7641* J7642* J7643* J7644 J7645* J7647* J7648** J7649** J7650* J7657* J7658** J7659** J7660* J7667* J7668** J7669 J7670* J7676* J7677 J7680* J7681* J7682 J7683*

Description Formoterol, inhalation solution, compounded product, administered through DME, unit dose form, 12 micrograms

Flunisolide, inhalation solution, compounded product, administered through DME, unit dose, per milligram

Glycopyrrolate, inhalation solution, compounded product, administered through DME, concentrated form, per milligram

Glycopyrrolate, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Ipratropium bromide, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per milligram

Ipratropium bromide, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Isoetharine HCL, inhalation solution, compounded product, administered through DME, concentrated form, per milligram

Isoetharine HCl, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, per mg

Isoetharine HCl, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per mg

Isoetharine HCL, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Isoproterenol HCL, inhalation solution, compounded product, administered through DME, concentrated form, per milligram

Isoproterenol HCl, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, per mg

Isoproterenol HCl, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per mg

Isoproterenol HCL, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Metaproterenol sulfate, inhalation solution, compounded product, concentrated form, per 10 milligrams

Metaproterenol sulfate, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, per 10 mg

Metaproterenol sulfate, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per 10 milligrams

Metaproterenol sulfate, inhalation solution, compounded product, administered through DME, unit dose form, per 10 milligrams

Pentamidine isethionate, inhalation solution, compounded product, administered through DME, unit dose form, per 300 mg

Revefenacin inhalation solution, FDA-approved final product, non-compounded, administered through DME, 1 mcg

Terbutaline sulfate, inhalation solution, compounded product, administered through DME, concentrated form, per milligram

Terbutaline sulfate, inhalation solution, compounded product, administered through DME, unit dose form, per milligram

Tobramycin, inhalation solution, FDA-approved final product, non-compounded, unit dose form, administered through DME, per 300 milligrams

Triamcinolone, inhalation solution, compounded product, administered through DME, concentrated form, per milligram

Nebulizers

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UnitedHealthcare Medicare Advantage Policy Guideline

Approved 06/08/2022

Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.

HCPCS Code J7684*

J7685*

J7686

J7699 K0730 Q0513 Q0514 Q4074

Description Triamcinolone, inhalation solution, compounded product, administered through DME, unit dose form, per milligram Tobramycin, inhalation solution, compounded product, administered through DME, unit dose form, per 300 milligrams Treprostinil, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, 1.74 mg NOC drugs, inhalation solution administered through DME Controlled dose inhalation drug delivery system Pharmacy dispensing fee for inhalation drug(s); per 30 days Pharmacy dispensing fee for inhalation drug(s); per 90 days Iloprost, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, up to 20 micrograms

Modifier KO KP KQ KX

Description Single drug unit dose formulation First drug of a multiple drug unit dose formulation Second or subsequent drug of a multiple drug unit dose formulation Requirements specified in the medical policy have been met

Place of Service Code

Description

As Defined By DME Supplier Manual

01

Pharmacy

04

Homeless Shelter

09

Prison/Correctional Facility

12

Home

13

Assisted Living Facility

14

Group Home

16

Temporary Lodging

33

Custodial Care Facility

54

Intermediate Care Facility/Mentally Retarded

55

Residential Substance Abuse Treatment Facility

56

Psychiatric Residential Treatment Center

65

End Stage Renal Disease (ESRD) Treatment Facility (valid POS for Parenteral Nutrition Therapy)

Diagnosis Code Nebulizers: Diagnosis Code List

Definitions

Compound Inhalation Solution: A product produced by a pharmacy that is not an FDA-approved manufacturer and involves the mixing, combining or altering of ingredients for an individual patient. Compounded drugs are not considered interchangeable with FDA-approved products.

Nebulizers

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UnitedHealthcare Medicare Advantage Policy Guideline

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