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June 24, 2021

LCD and Policy Article Revisions Summary for June 24, 2021

Outlined below are the principal changes to the DME MAC Local Coverage Determinations (LCDs) and Policy Articles (PAs) that have been revised and posted. The policies included are Oral Appliances for Obstructive Sleep Apnea, Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea, and Respiratory Assist Devices. Please review the entire LCDs and related PAs for complete information.

Oral Appliances for Obstructive Sleep Apnea

LCD

Oral Appliances for Obstructive Sleep Apnea LCDExternal website

Revision Effective Date: 08/08/2021

COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:

  • Revised: "face-to-face" to "in-person"
  • Removed: Not reasonable and necessary denial statement regarding custom fabricated mandibular advancement devices that do not receive written coding verification
  • 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 (A58823)

PA

Oral Appliances for Obstructive Sleep Apnea PAExternal website

Revision Effective Date: 08/08/2021

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

  • Added: Language regarding no aspect of a home sleep test may be performed by a DME supplier

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

  • Revised: "face-to-face" to "in-person"
  • Revised: History elements of the treating practitioners evaluation by separating the "sleep hygiene inventory" from the "duration of symptoms" bullet

MODIFIERS:

  • Revised: The reference to the coverage criteria within the "Coverage Indications, Limitations, and/or Medical Necessity" section of the LCD

CODING GUIDELINES:

  • Revised: Coding Verification Review statement for E0486 by removing "appropriate" prior to "Product Classification List"
  • Added: Incorrect coding denial statement for HCPCS codes that do not receive written coding verification review
  • Removed: Language related to the use of HCPCS code A9270 when coding verification was not received

06/24/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea

LCD

Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCDExternal website

Revision Effective Date: 08/08/2021

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

  • Revised: The CMS manual reference to CMS Pub. 100-03
  • Revised: Sleep Tests section to point to NCD 240.4.1 and applicable A/B MAC LCDs and Billing and Coding articles
  • Removed: Appendix B "List of Approved Other Devices that Indirectly Measure AHI/RDI"

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 (A58824)

PA

Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea PAExternal website

Revision Effective Date: 08/08/2021

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

  • Revised: Medicare Benefit Policy Manual reference

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

  • Revised: Typographical error, by adding comma after "Limitations" when referencing "Coverage Indications, Limitations, and/or Medical Necessity"

CODING GUIDELINES:

  • Revised: Language related to HCPCS code A9279 and the incorrect use of NOC codes for monitoring technologies

06/24/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Respiratory Assist Devices

LCD

Respiratory Assist Devices LCDExternal website

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)

PA

Respiratory Assist Devices PAExternal website

Revision Effective Date: 08/08/2021

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

  • Added: Language regarding no aspect of a home sleep test may be performed by a DME supplier
  • Revised: Language regarding a liner used in conjunction with a PAP mask are noncovered
  • Added: Language regarding monitoring devices are statutorily non-covered (previously under Coding Guidelines)

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

  • Revised: Coverage, coding and documentation requirements reference from "see below" to "see Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD"

MODIFIERS:

  • Removed: Reference to "Group I – IV" from KX modifier section as groups are no longer referenced in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD
  • Revised: Typographical errors to add commas after "Limitations" when referencing "Coverage Indications, Limitations, and/or Medical Necessity"
  • Added: Statement of claim line rejection if billed without GA, GZ or KX modifier (previously noted in the LCD)

CODING GUIDELINES:

  • Revised: Language related to HCPCS code A9279 and monitoring devices and services

06/24/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Note: The information contained in this article is only a summary of revisions to the LCDs and PAs. For complete information on any topic, you must review the LCDs and/or PAs.

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