Nebulizers – Medicare Advantage Policy Guideline

UnitedHealthcare® Medicare Advantage Policy Guideline Nebulizers

Guideline Number: MPG211.05 Approval Date: July 8, 2020  Terms and Conditions

Table of Contents Page Related Medicare Advantage Reimbursement Policy Policy Summary ...... 1 • Durable Medical Equipment Charges in a Skilled Applicable Codes ...... 2 Nursing Facility Policy, Professional Definitions ...... 6 Questions and Answers ...... 6 Related Medicare Advantage Coverage Summary References ...... 6 • Durable Medical Equipment (DME), Prosthetics, Guideline History/Revision Information ...... 7 Corrective Appliances/Orthotics (Non-Foot Purpose ...... 7 Orthotics) and Medical Supplies Grid Terms and Conditions ...... 7

Policy Summary

 See Purpose Overview Nebulizers can be covered if the member’s ability to breathe is severely impaired.

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. 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.

Nebulizers require an in-person or face-to-face interaction between the beneficiary and their treating physician prior to prescribing the item, specifically to document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered. A dispensing order is not sufficient to provide these items. A WOPD (written order prior to delivery) is required.

Detailed documentation requirements are outlined in Nebulizer LCD.

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 Description 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 (Non-covered) A7009 Reservoir bottle, non-disposable, used w/ large volume ultrasonic nebulizer (Non-covered) 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 A7018 Water, distilled, used with large volume nebulizer, 1000 ml 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 (Non-covered) E0580 Nebulizer, durable, glass or autoclavable plastic, bottle type, for use with regulator or flowmeter E0585 Nebulizer, with compressor and heater E1372 Immersion external heater for nebulizer 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

HCPCS Code Description 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 J7633** Budesonide, inhalation solution, FDA-approved final product, noncompounded, administered through DME, concentrated form, per 0.25 mg 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 mg 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

HCPCS Code Description 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 J7648** Isoetharine HCl, inhalation solution, FDA-approved final product, noncompounded, administered through DME, concentrated form, per mg J7649** Isoetharine HCl, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per mg 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 J7658** Isoproterenol HCl, inhalation solution, FDA-approved final product, noncompounded, administered through DME, concentrated form, per mg J7659** Isoproterenol HCl, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per mg 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 J7668** Metaproterenol sulfate, inhalation solution, FDA-approved final product, noncompounded, administered through DME, concentrated form, per 10 mg 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 J7677 Revefenacin inhalation solution, FDA-approved final product, noncompounded, administered through DME, 1 mcg (Effective 07/01/2019) 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

HCPCS Code Description 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 K0730 Controlled dose inhalation drug delivery sstem 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

Modifier Description 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

Place of Service Description Code 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.

Questions and Answers

1 Q: Is a large volume ultrasonic nebulizer (HCPCS E0575) covered by Medicare? A: A large volume ultrasonic nebulizer offers no proven clinical advantage over a pneumatic compressor and nebulizer and will be denied as not reasonable and necessary. 2 Q: Are compound inhalation solutions covered by Medicare? A: CMS revoked coverage of compounded inhalation solutions in 2007. 3 Q: Are there any restrictions around nebulizers and home oxygen use? A: A large volume pneumatic nebulizer (HCPCS E0580) and water or saline (HCPCS A4217 or A7018) are not separately payable and should not be separately billed when used for beneficiaries with rented home oxygen equipment.

References

CMS National Coverage Determinations (NCDs) NCD 200.2 Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases NCD 280.1 Durable Medical Equipment Reference List

CMS Local Coverage Determinations (LCDs) and Articles

LCD Article Contractor DME MAC L33370 Nebulizers A52466 Nebulizers – Policy CGS AL, AR, CO, FL GA, LA, MS, NC, NM, Article OK, PR, SC, TN, TX, VA, VI, WV, IL, IN, KT, MI, MN, OH, WI Noridian AK, AS, AZ, CA (Entire State), GU, HI, IA, ID, KA, MO (Entire State), MT, ND, NE, NV, OR, SD, UT, WA, WY, NMI, CT, DOC, DE, MA, MD, ME, NH, NJ, NY (Entire State), PA, RI, VT

CMS Claims Processing Manual Chapter 12 Physician/Nonphysician Practitioners Chapter 20 Durable Medical Equipment, Prosthetics and Orthotics, and Supplies (DMEPOS) Chapter 23 Fee Schedule Administration and Coding Requirements

MLN Matters Article MM8304, Detailed Written Orders and Face-to-Face Encounters Article SE1326, Overutilization of Nebulizer Medications

Other(s) CMS Revokes Coverage of Compounded Inhalation Solutions, Further Revises Nebulizer Medical Policy, HME Business Management Solutions Website

Guideline History/Revision Information

Revisions to this summary document do not in any way modify the requirement that services be provided and documented in accordance with the Medicare guidelines in effect on the date of service in question.

Date Summary of Changes 04/01/2021 Template Update Reformatted policy; transferred content to new template 07/08/2020 Applicable Codes Added HCPCS code J7677 ICD-10 Diagnosis Codes For HCPCS Code A7016, E0574, J7686, K0730, and Q4074 Removed ICD-10 diagnosis codes I27.21 and I27.29 Supporting Information Updated References section to reflect the most current information Archived previous policy version MPG211.04

Purpose

The Medicare Advantage Policy Guideline documents are generally used to support UnitedHealthcare Medicare Advantage claims processing activities and facilitate providers’ submission of accurate claims for the specified services. The document can be used as a guide to help determine applicable: Medicare coding or billing requirements, and/or Medical necessity coverage guidelines; including documentation requirements.

UnitedHealthcare follows Medicare guidelines such as NCDs, LCDs, LCAs, and other Medicare manuals for the purposes of determining coverage. It is expected providers retain or have access to appropriate documentation when requested to support coverage. Please utilize the links in the References section below to view the Medicare source materials used to develop this resource document. This document is not a replacement for the Medicare source materials that outline Medicare coverage requirements. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will apply.

Terms and Conditions

The Medicare Advantage Policy Guidelines are applicable to UnitedHealthcare Medicare Advantage Plans offered by UnitedHealthcare and its affiliates.

These Policy Guidelines are provided for informational purposes, and do not constitute medical advice. Treating physicians and healthcare providers are solely responsible for determining what care to provide to their patients. Members should always consult their physician before making any decisions about medical care.

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 member specific benefit plan document identifies which services are covered, which are excluded, and which are subject to limitations. In the event of a conflict, the member specific benefit plan document supersedes the Medicare Advantage Policy Guidelines.

Medicare Advantage Policy Guidelines are developed as needed, are regularly reviewed and updated, and are subject to change. They represent a portion of the resources used to support UnitedHealthcare coverage decision making. UnitedHealthcare may modify these Policy Guidelines at any time by publishing a new version of the policy on this website. Medicare source materials used to develop these guidelines include, but are not limited to, CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Medicare Benefit Policy Manual, Medicare Claims Processing Manual, Medicare Program Integrity Manual, Medicare Managed Care Manual, etc. The information presented in the Medicare

Advantage Policy Guidelines is believed to be accurate and current as of the date of publication and is provided on an "AS IS" basis. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will apply.

You are responsible for submission of accurate claims. Medicare Advantage Policy Guidelines are intended to ensure that coverage decisions are made accurately based on the code or codes that correctly describe the health care services provided. UnitedHealthcare Medicare Advantage Policy Guidelines use Current Procedural Terminology (CPT®), Centers for Medicare and Medicaid Services (CMS), or other coding guidelines. References to CPT® or other sources are for definitional purposes only and do not imply any right to reimbursement or guarantee claims payment.

Medicare Advantage Policy Guidelines are the property of UnitedHealthcare. Unauthorized copying, use, and distribution of this information are strictly prohibited.

*For more information on a specific member's benefit coverage, please call the customer service number on the back of the member ID card or refer to the Administrative Guide.

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