Local Coverage Determination (LCD)

Nebulizers

L33370

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33370
Original ICD-9 LCD ID
Not Applicable
LCD Title
Nebulizers
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33370
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 01/01/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
04/21/2022
Notice Period End Date
06/04/2022

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Issue

Issue Description

The LCD is revised to align refill requirements with CMS Final Rule CMS-1780-F. This revision allows contact with the beneficiary regarding refills to take place no sooner than 30 calendar days prior to the end of the current supply and to document an affirmative response.

Issue - Explanation of Change Between Proposed LCD and Final LCD

No proposed LCD issued. 

CMS National Coverage Policy

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 200.2, Section 280.1

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.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

  • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  • Refer to the Supplier Manual for additional information on documentation requirements.

  • Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, 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.

Payment may be made for supplies that are necessary for the effective use of durable medical equipment. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment or to assure the proper functioning of the equipment. However, the coverage of such drugs or biologicals does not preclude the need for a determination that the drug or biological itself is reasonable and necessary for treatment of the illness or injury or to improve the functioning of a malformed body member.

A small volume nebulizer (A7003, A7004, A7005), and related compressor (E0570) are considered for coverage when it is reasonable and necessary to administer the following FDA-approved inhalation solutions listed below (refer to the Group 3 Codes in the LCD-related Policy Article for applicable diagnoses):

  1. It is reasonable and necessary to administer albuterol (J7611, J7613), arformoterol (J7605), budesonide (J7626), cromolyn (J7631), formoterol (J7606), ipratropium (J7644), levalbuterol (J7612, J7614), metaproterenol (J7669), or revefenacin (J7677) for the management of obstructive pulmonary disease (refer to the Group 8 Codes in the LCD-related Policy Article for applicable diagnoses); or

  2. It is reasonable and necessary to administer dornase alfa (J7639) to a beneficiary with cystic fibrosis (refer to the Group 9 Codes in the LCD-related Policy Article for applicable diagnoses); or

  3. It is reasonable and necessary to administer tobramycin (J7682) to a beneficiary with cystic fibrosis or bronchiectasis (refer to the Group 10 Codes in the LCD-related Policy Article for applicable diagnoses); or

  4. It is reasonable and necessary to administer pentamidine (J2545) to a beneficiary with HIV, pneumocystosis, or complications of organ transplants (refer to the Group 4 Codes in the LCD-related Policy Article for applicable diagnoses); or

  5. It is reasonable and necessary to administer acetylcysteine (J7608) for persistent thick or tenacious pulmonary secretions (refer to the Group 7 Codes in the LCD-related Policy Article 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 considered for coverage 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 (refer to the Group 5 Codes in the LCD-related Policy Article for applicable diagnoses). Combination code E0585 will be covered for the same indications.

An E0565 or E0572 compressor and filtered nebulizer (A7006) are considered for coverage when it is reasonable and necessary to administer pentamidine to beneficiaries with HIV, pneumocystosis, or complications of organ transplants (refer to the Group 1 Codes in the LCD-related Policy Article for applicable diagnoses).

A small volume ultrasonic nebulizer (E0574) and related accessories are considered for coverage when it is reasonable and necessary to administer treprostinil inhalation solution to beneficiaries with pulmonary hypertension only (refer to the Group 11 Codes in the LCD-related Policy Article for applicable diagnoses). Claims for code E0574 used with other inhalation solutions will be denied as not reasonable and necessary.

Treprostinil inhalation solution (J7686) is considered for coverage when either criteria 1-3; or, criterion 4 are met:

  1. The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 11 Codes in the LCD-related Policy Article for applicable diagnoses); and

  2. The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease) or disorders of the respiratory system other than interstitial lung disease (see criterion 4) (e.g., chronic obstructive pulmonary disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders); and

  3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, 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:

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

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

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

    4. Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.

  4. The beneficiary has a diagnosis of pulmonary hypertension associated with interstitial lung disease (refer to Group 11 Codes in the LCD-related Policy Article for applicable diagnoses) and the following criteria (a-e) are met:

    1. The presence of interstitial lung disease has been confirmed by a high-resolution CT scan of the chest; and

    2. The mean pulmonary artery pressure is ≥ 25 mm Hg; and

    3. The pulmonary capillary wedge pressure or left ventricular end-diastolic pressure is ≤ 15mm Hg; and

    4. The pulmonary vascular resistance is ≥ 3 Wood Units at rest; and

    5. The beneficiary has significant symptoms of pulmonary hypertension (e.g., dyspnea on exertion, fatigability)

If the above criteria are not met, code E0574 and the related drug treprostinil (J7686) will be denied as not reasonable and necessary.

A controlled dose inhalation drug delivery system (K0730) is considered for coverage when it is reasonable and necessary to administer iloprost (Q4074) to beneficiaries with pulmonary hypertension only (refer to the Group 14 Codes in the LCD-related Policy Article for applicable diagnoses). Claims for code K0730 for use with other inhalation solutions will be denied as not reasonable and necessary.

Iloprost (Q4074) is considered for coverage when all of the following criteria 1-3 are met:

  1. The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 14 Codes in the LCD-related Policy Article for applicable diagnoses); and

  2. The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease) 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); and

  3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, 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:

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

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

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

    4. 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 K0730 and the related drug iloprost (Q4074) 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 alfa 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
Revefenacin 5250 mcg/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

 

Claims for more than these amounts of drugs will be denied as not reasonable and necessary.

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.

Revefenacin (J7677) is a long-acting muscarinic antagonist. Concurrent use of long-acting and short-acting muscarinic antagonists, such as ipratropium (J7644) is not reasonable and necessary. Therefore, if a long-acting muscarinic antagonist is used, the short-acting muscarinic antagonist 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, J7612, J7613, 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. Practitioners may submit a claim for drugs if all of the following conditions are met: the practitioner is 1) enrolled as a durable medical equipment, prosthetics, orthotics and supplies (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 practitioner’s license. Claims submitted by entities not licensed to dispense drugs will be denied for lack of medical necessity.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall 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 that are supplied as refills to the original order, suppliers must contact the beneficiary, and document an affirmative response, 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 expected to end, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee and document an affirmative response, prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request and an affirmative response 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 treating 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.

DRUG WASTAGE

Claims for drugs billed to Medicare must use drug dosage formulations and/or unit dose sizes that minimize wastage. Medicare provides payment for the amount of a single use vial or other single use package of drug or biological discarded, in addition to the dose administered. (See the MODIFIERS section of the Nebulizers LCD-related Policy Article.)

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

DOCUMENTATION 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.” It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

  • SWO

  • Medical Record Information (including continued need/use if applicable)

  • Correct Coding

  • Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met to justify Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

Miscellaneous

Appendices

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

Sources of Information
N/A
Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
01/01/2024 R12

Revision Effective Date: 01/01/2024
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
Revised: “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.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”

12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

  • Provider Education/Guidance
  • Other (CMS Final Rule CMS-1780-F)
01/01/2023 R11

Revision Effective Date: 01/01/2023
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: Instructions to DRUG WASTAGE section to see MODIFIERS section of the LCD-related Policy Article
Removed: JW and JZ modifier instructions from DRUG WASTAGE section

06/15/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2023 R10

Revision Effective Date: 01/01/2023
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: JZ modifier to the DRUG WASTAGE section
SUMMARY OF EVIDENCE:
Removed: Summary of evidence information, due to not being applicable to the non-discretionary changes
ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):
Removed: Analysis of evidence information, due to not being applicable to the non-discretionary changes
CODING INFORMATION:
Added: JZ modifier 
BIBLIOGRAPHY:
Removed: Bibliography information, due to not being applicable to the non-discretionary changes

01/12/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
06/05/2022 R9

Revision Effective Date: 06/05/2022
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Group 3 Codes reference for small volume nebulizer (A7003, A7004, A7005) and related compressor (E0570)
Revised: Language regarding coverage of E0574, to include administration of Treprostinil inhalation solution to beneficiaries with pulmonary hypertension only and reference to Group 11 Codes in the LCD-related PA
Revised: Coverage criteria for treprostinil and iloprost
Added: Separate criteria language for iloprost
Removed: Thromboembolic disease of the pulmonary arteries from criteria for treprostinil and iloprost
Added: Criterion 4 to treprostinil coverage criteria and reference to Group 11 Codes in the LCD-related PA
Added: Reference to Group 14 Codes in the LCD-related PA for iloprost
SUMMARY OF EVIDENCE:
Added: Information related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
ANALYSIS OF EVIDENCE:
Added: Information related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
BIBLIOGRAPHY:
Added: Section related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A59085)

  • Provider Education/Guidance
  • Reconsideration Request
05/17/2020 R8

Revision Effective Date: 05/17/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Statement regarding base and related accessories and supplies (BPM Ch. 15, Section 110.3)
Clarified: “considered for coverage” to drug and equipment criteria
Added: Revefenacin to inhalation solutions for the management of obstructive pulmonary disease - For Dates of Service on or after 11/9/2018 (FDA Approval Date)
Revised: “alpha” to “alfa” in relation to HCPCS code J7639
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 codes in the LCD-related Policy Article
Revised: “alpha” to “alfa” in table with maximum milligrams/month
Added: Revefenacin to table with maximum milligrams/month
Added: Information regarding concurrent use of long-acting and short-acting muscarinic antagonists
Revised: Format of HCPCS code references, from code ‘spans’ to individually-listed HCPCS codes 
Revised: "physician" to "practitioner"
Revised: Order information as a result of Final Rule 1713
REFILL REQUIREMENTS:
Revised: "ordering physicians" to "treating practitioners" 
SUMMARY OF EVIDENCE:
Added: Information related to revefenacin
ANALYSIS OF EVIDENCE:
Added: Information related to revefenacin
HCPCS CODES:
Added: J7677 to Group 3 Codes in the HCPCS code table
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO
BIBLIOGRAPHY:
Added: Section related to revefenacin
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A58035)

  • Provider Education/Guidance
  • Reconsideration Request
  • Other
01/01/2019 R7

Revision Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Statements to refer to diagnosis code section below
Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statements about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

  • Other (ICD-10 code relocation per CMS instruction)
10/01/2017 R6

Revision Effective Date: 10/01/2017

Coverage Indications, Limitations and/or Medical Necessity:
Update: References to ICD-10 Codes that Support Medical Necessity
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: New ICD-10 codes to Groups 11, 12, 13
Deleted: Non-valid ICD-10 codes from Group 11, 12, 13
Revised: ICD-10 code descriptions in Groups 2, 3, 7, 12, 13
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Update: Language to add “justify”, for Medicare reimbursement

10/26/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
01/01/2017 R5 Revision Effective Date: 01/01/2017
Removed: Standard Documentation Language
Added: New reference language and Directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
Revised: Drug Wastage verbiage
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and Directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Directions to Standard Documentation Requirements
Removed: Information from Miscellaneous
Removed: PIM reference from Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
07/01/2016 R4 Revision Effective Date: 07/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard documentation language - ACA requirements – Effective 04/28/16
Added: A7007 and A7017 related accessories table for E0572
Added: Denial verbiage for JW Modifier when coverage criteria not met - Effective 01/01/17
HCPCS MODIFIERS:
Added: JW Modifier – Effective January 1, 2017
DOCUMENTATION REQUIREMENTS:
Revised: Standard documentation language for orders and ACA requirements, added New order requirements, and Correct coding instructions; revised Refill requirements to change "should" to "must", revised Proof of delivery instructions – Effective 04/28/16
Added: JW Modifier instructions – Effective January 1, 2017
  • Provider Education/Guidance
07/01/2016 R3 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
01/01/2016 R2 Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Deleted: HCPCS Code A7011 from Accessories tables
HCPCS CODES:
Deleted: HCPCS Code A7011
Added: HCPCS Code J7999
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Group 5 Codes:
Deleted: Code A7011 from the List of HCPCS codes
Group 7 Codes:
Added: ICD-10 Code E84.0 to Group 7 for J7608
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation language to remove start date verbiage from Prescription Requirements (Effective 11/05/2015)
MISCELLANEOUS:
Deleted: Duplicative information about what is required on orders
Updated: HCPCS Code Q9977 cross-walked to J7999
Added: Standard product identification requirements for NOC codes
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 Revision Effective Date: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for Equipment Retained from a Prior Payer
Revised: Repair to beneficiary-owned DMEPOS
MISCELLANEOUS:
Added: Instructions for HCPCS code Q9977 - Effective 07/01/2015
  • Provider Education/Guidance
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Updated On Effective Dates Status
12/07/2023 01/01/2024 - N/A Currently in Effect You are here
06/08/2023 01/01/2023 - 12/31/2023 Superseded View
01/05/2023 01/01/2023 - N/A Superseded View
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