Respiratory Assist Devices

Revision Effective Date: 06/09/2025
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: “INITIAL COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES FOR THE FIRST THREE MONTHS OF THERAPY” to “INITIAL COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES”


10/30/2025: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates due to NCD 240.9 Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure (CRF) Consequent to Chronic Obstructive Pulmonary Disease (COPD).

Revision Effective Date: 06/09/2025
CMS NATIONAL COVERAGE POLICY:
Added: "CMS Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 240.9"
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised:
Initial coverage of E0470 and E0471 language, by removing “severe chronic obstructive pulmonary disease (COPD)” and adding “chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD)”
Removed: Severe COPD
and related coverage criteria
Revised: Hypoventilation Syndrome coverage criterion B for E0740 and criterion B for E0471, by removing “SEVERE COPD (above)” and adding “Chronic Respiratory Failure Consequent to COPD”
Added:
“Chronic Respiratory Failure Consequent to COPD” and related coverage information
Added:
“The Medicare National Coverage Determinations (NCD) Manual (CMS Pub. 100-03) Chapter 1, Part 4, Section 240.9 outlines initial and continuing usage criteria for home mechanical ventilators for the treatment of CRF consequent to COPD.”

to the ventilators coverage information
Added: "(See §240.9 of this manual)" to quote from NCD 280.1 in section for Ventilators
Added: "and consideration of coverage criteria outlined in the Respiratory Assist Devices LCD, NCD 280.1, and/or NCD 240.9" in section for Ventilators
Revised: “CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS OF THERAPY” to “CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS OF THERAPY FOR RESTRICTIVE THORACIC DISORDERS, CSA, COMPSA, OR HYPOVENTILATION SYNDROME”

Revised: “Beneficiaries covered for the first three months of an E0470 or an E0471 device must be re-evaluated to establish the medical necessity of continued coverage by Medicare beyond the first three months.” to “Beneficiaries covered for the first three months of an E0470 or an E0471 device for the treatment of restrictive thoracic disorders, CSA, CompSA, or hypoventilation syndrome must be re-evaluated to establish the medical necessity of continued coverage by Medicare beyond the first three
months.”
Added: “CONTINUED COVERAGE CRITERIA FOR E0470 OR E0471 DEVICES BEYOND THE FIRST SIX MONTHS FOR CRF CONSEQUENT TO COPD” and related coverage information

Added: Header to table that represents the maximum amount of accessories expected to be reasonable and necessary
Revised: “For beneficiaries who received an E0470 or E0471 device prior to enrollment in fee-for-service (FFS) Medicare and are seeking Medicare reimbursement for a rental, either to continue using the existing device or for a replacement device, coverage transition is not automatic.” to “For beneficiaries who received an E0470 or E0471 device for the treatment of restrictive thoracic disorders, CSA, CompSA, or hypoventilation syndrome prior to enrollment in fee-for-service (FFS) Medicare and are seeking Medicare reimbursement for a rental, either to continue using the existing device or for a replacement device, coverage transition is not automatic.” regarding beneficiaries entering Medicare
RELATED NATIONAL COVERAGE DOCUMENTS:
Added: NCD 240.9


10/09/2025: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates due to NCD 240.9 Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure (CRF) Consequent to Chronic Obstructive Pulmonary Disease (COPD).

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.”
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


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.

REVISION EFFECTIVE DATE: 08/08/2021
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: ‘etc.’ from initial coverage statement for E0470 or an E0471 RAD
Revised: Situation 1 and 2 revised “Group II” to “severe COPD” beneficiaries
Revised: Situation 1 criterion B to proper LCD title, Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea for E0471
Revised: Hypoventilation Syndrome criterion D to proper LCD title, Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea for E0470 and E0471
Revised: Header from “VENTILATOR WITH NOINVASIVE INTERFACES” to “VENTILATOR”
Revised: The CMS manual reference to CMS Pub. 100-03
Added: HCPCS code E0467 to ventilator code listings
Revised: “Patient” to “beneficiary”
Removed: Statement of claim line rejection if billed without GA, GZ or KX modifier
Removed: “etc.” from BENEFICIARIES ENTERING MEDICARE section
Revised: SLEEP TESTS section to point to NCD 240.4.1 and applicable A/B MAC LCDs and Billing and Coding articles
SUMMARY OF EVIDENCE:
Added: Information related to diagnostic sleep testing
ANALYSIS OF EVIDENCE:
Added: Information related to diagnostic sleep testing
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A58822)

Revision Effective Date: 01/01/2020
 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
 Revised: “physician” to “practitioner”
 GENERAL:
 Revised: Order information as a result of Final Rule 1713
 REFILL REQUIREMENTS:
 Revised: “ordering physicians” to “treating practitioners”
 REPLACEMENT:
 Revised: “physician” to “treating practitioner”
 BENEFICIARIES ENTERING MEDICARE:
 Revised: “physician” to “treating practitioner”
 SLEEP TESTS:
 Revised: “physician” to “practitioner”
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"
 DOCUMENTATION REQUIREMENTS:
 Revised: “physician’s” to “treating practitioner’s”
 GENERAL DOCUMENTATION REQUIREMENTS:
 Revised: “Prescriptions (orders)” to “SWO”
 POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
 Revised: “physician” updated to “treating practitioner”


02/27/20: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713.

No changes have been made to this LCD


04/05/2018: 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.

Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Clarified: Distinction between coverage of RAD devices and ventilators with non-invasive interfaces
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
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: Direction to Standard Documentation Requirements
Removed: Supplier Manual direction under Miscellaneous
Removed: PIM citation under Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article

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.

Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Replaced: HCPCS Codes E0450, E0460-E0464 with new HCPCS Codes E0465, E0466
DOCUMENTATION REQUIREMENTS
Revised: Standard Documentation language to remove start date verbiage from Prescription Requirements (Effective 11/05/2015)

Revision Effective Date: 12/01/2014 (May 2015 Publication)
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
Added: Repair/Replacement section

Revision Effective Date: 10/01/2015
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Definitions of Central Sleep Apnea and Complex Sleep Apnea to include a CAHI index and expands signs and symptoms that describe the conditions
Revised: Severe COPD to clarify that definitive testing is not necessary to exclude OSA when the clinical picture is sufficient
Revised: Severe COPD to clarify that nocturnal oximetry is a cumulative 5 minutes of testing
Revised: Hypoventilation Syndromes to remove FEV1
Revised: PSG testing to also include HST testing when used in the in-patient hospital setting to establish or rule out the diagnosis of OSA
Added: Ventilator section based upon NCD and April 2014 coding and coverage article
Added: Sleep Test coverage and payment rules