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

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.

Revision Effective Date: 09/27/2021
CONCURRENT USE OF OXYGEN WITH PAP THERAPY:
Removed: “for 5 minutes total (which need not be continuous)” under criterion 4 for overnight oximetry testing for beneficiaries with OSA


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 due to updates to National Coverage Determination 240.2.

Revision Effective Date: 09/27/2021
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: References to “chronic stable state” from CONCURRENT USE OF OXYGEN WITH PAP THERAPY
Removed: “severe lung disease” from CONCURRENT USE OF OXYGEN WITH PAP THERAPY
Added: “condition resulting in hypoxemia” to CONCURRENT USE OF OXYGEN WITH PAP THERAPY
Added: “therapy and oxygen equipment” after statements of “oxygen” and “home oxygen” to CONCURRENT USE OF OXYGEN WITH PAP THERAPY
Added: “and oxygen equipment” after statements of “oxygen therapy” and “home oxygen therapy” to CONCURRENT USE OF OXYGEN WITH PAP THERAPY
Added: Ineligibility for coverage of home oxygen with overnight oximetry as part of home sleep testing or any other home testing to CONCURRENT USE OF OXYGEN WITH PAP THERAPY
Added: “Beneficiaries that qualify for oxygen therapy based on testing conducted only during the course of a sleep test are eligible only for reimbursement of stationary equipment.” to CONCURRENT USE OF OXYGEN WITH PAP THERAPY
Removed: Duplicate instruction for suppliers to refer to the Oxygen and Oxygen Equipment LCD and related Policy Article for additional coverage, coding and documentation requirements from CONCURRENT USE OF OXYGEN WITH PAP THERAPY
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


11/17/2022: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates due to updates to National Coverage Determination 240.2 and removal of National Coverage Determination 240.2.2.

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)

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: “face-to-face” to “in-person” where applicable
Revised: "practitioner" to "treating practitioner"
Revised: Order information as a result of Final Rule 1713
REFILL REQUIREMENTS:
Revised: Format of HCPCS code references, from code spans to individually-listed HCPCS
Revised: “ordering physicians” to “treating practitioners”
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


03/05/2020: 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, HCPCS code changes, and non-substantive corrections (listing individual HCPCS codes instead of a HCPCS code-span).

Revision Effective Date: 01/01/2019
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: Diagnosis code to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statement about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Revised: Appendix A - updated Epworth Sleepiness Scale reference to AMA format

Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard
Added: Clarifying language “obtained during polysomnograpghy” to CONCURRENT USE OF OXYGEN WITH PAP THERAPY
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: Miscellaneous billing instructions (moved to related PA)
Removed: PIM reference from Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article

Revision Effective Date: 07/01/2016
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: American Osteopathic Association to physician credentials for interpreting sleep test
Revised: Standard Documentation language - ACA requirements Effective 04/28/2016
DOCUMENTATION REQUIREMENTS:
Revised: Standard documentation language to revise Refill documentation changing "should to must", ACA requirements, and Proof of deliver instructions; added New order requirements and Correct coding instructions (Effective 04/28/2016)

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: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Language
Added: Language from RAD LCD allowing Sleep study Types II, III, IV testing in facility setting
DOCUMENTATION REQUIREMENTS:
Revised: Standard Language

Revision Effective Date: 10/01/2014
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: HCPCS codes E0470 and E0471 to the ACA 6407 requirement table (effective 07/01/2013)