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November 17, 2022

LCD and Policy Article Revisions Summary for November 17, 2022

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

Enteral Nutrition, External Infusion Pumps, High Frequency Chest Wall Oscillation Devices, Immunosuppressive Drugs, Osteogenesis Stimulators, Oxygen and Oxygen Equipment, Parenteral Nutrition, Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea, Seat Lift Mechanisms, and Transcutaneous Electrical Nerve Stimulators (TENS). Please review the entire LCDs and related PAs for complete information.

Enteral Nutrition

LCD

Enteral Nutrition LCD

Revision Effective Date: 01/01/2023

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

Revised: Language pertinent to the feeding supply allowance corresponding to the method of administration
Revised: Reference to DIF question 5, to clarify it is for dates of services prior to January 1, 2023

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

BIBLIOGRAPHY:

Removed: Bibliography 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 CMS Change Request (CR) 12734: Elimination of Certificates of Medical Necessity and DME Information Forms.

PA

Enteral Nutrition PA

Revision Effective Date: 01/01/2023

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Added: Billing information relevant to DIFs, for DOS affected by the DIF elimination

CODING GUIDELINES:

Added: Information pertaining to the need for calculation of UOS based on the treating practitioner's order

11/17/2022: 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.

External Infusion Pumps

PA

External Infusion Pumps PA

Revision Effective Date: 01/01/2023

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Added: Billing information relevant to DIFs, for DOS affected by the DIF elimination

11/17/2022: At this time the 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.

High Frequency Chest Wall Oscillation Devices

LCD

High Frequency Chest Wall Oscillation Devices LCD

Revision Effective Date: 10/01/2022

HCPCS CODES:

Revised: E0483 HCPCS long descriptor

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 CMS HCPCS coding determinations.

PA

High Frequency Chest Wall Oscillation Devices PA

Revision Effective Date: 10/01/2022

CODING GUIDELINES:

Revised: E0483 HCPCS long descriptor

11/17/2022: 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.

Immunosuppressive Drugs

PA

Immunosuppressive Drugs PA

Revision Effective Date: 01/01/2023

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

Revised: Medicare entitlement statement to include coverage beyond 36 months for beneficiaries eligible and enrolled in the Part B immunosuppressive drug benefit (PBID)

11/17/2022: 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.

Osteogenesis Stimulators

PA

Osteogenesis Stimulators PA

Revision Effective Date: 01/01/2023

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Added: Billing information relevant to CMNs, for DOS affected by the CMN elimination

11/17/2022: At this time the 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.

Oxygen and Oxygen Equipment

LCD

Oxygen and Oxygen Equipment LCD

Revision Effective Date: 01/01/2023

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

Added: Language in regard to CMS' codification of nationally covered and non-covered indications for home oxygen and oxygen equipment within the NCD Manual section 240.2 and section 1862(a)(1)(A) of the SSA (effective 09/27/2021)
Added: "therapy and oxygen equipment" after statements of "oxygen" and "home oxygen"
Added: "and oxygen equipment" after statements of "oxygen therapy" and "home oxygen therapy"
Added: "Initial coverage" of home oxygen therapy (effective 09/27/2021)
Revised: Reasonable and necessary criteria for Groups I and II home oxygen therapy and oxygen equipment (effective 09/27/2021)
Removed: References to "chronic stable state" (effective 09/27/2021)
Added: Coverage criteria for Group III home oxygen therapy and oxygen equipment (effective 09/27/2021)
Added: Group IV criteria
Removed: Long Term Oxygen Therapy (LTOT) Clinical Trials
Removed: "CLUSTER HEADACHES (CH)" section and related information
Added: "cluster headaches" as a medical condition example in Group III
Removed: All references and instructions for the Certificate of Medical Necessity
Added: Group I, II or III for high litter flow allowance criteria

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:

Removed: Q0 modifier

APPENDICES:

Removed: Cluster headaches and LTOT special coverage rules

SOURCES OF INFORMATION:

Added: Home use of Oxygen and Home Oxygen Use to Treat Cluster Headaches Decision Memorandum (CAG-00296R2)
Added: Home Use of Oxygen Decision Memo (CAG-00296R3)
Removed: "CR7235 for cluster headache trial"

BIBLIOGRAPHY:

Removed: Bibliography 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, removal of National Coverage Determination 240.2.2 and CMS Change Request (CR) 12734: Elimination of Certificates of Medical Necessity and DME Information Forms.

PA

Oxygen and Oxygen Equipment PA

Revision Effective Date: 01/01/2023

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

Added: Reference to Social Security Act §1834(a)(5)(E)

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Removed: References to chronic stable state (effective 09/27/2021)
Revised: Documentation requirements to align with information in the Coverage Indications, Limitations, and/or Medical Necessity section of the related Oxygen and Oxygen Equipment LCD (effective 09/27/2021)
Removed: "LONG TERM OXYGEN THERAPY TRIALS (LTOT)" section and related information (effective 09/27/2021)
Removed: "CLUSTER HEADACHES" section and related information (effective 09/27/2021)

REPLACEMENT EQUIPMENT:

Removed: References to "Recertification" and "Certification of Medical Necessity"

CERTIFICATE OF MEDICAL NECESSITY (CMN):

Removed: Section and related information

CODING GUIDELINES:

Removed: Clinical trial information for cluster headaches

ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:

Removed: Group 1 Paragraph information
Removed: ICD-10-CM codes from Group 1 Codes
Removed: Group 2 Paragraph information
Removed: ICD-10-CM code from Group 2 Codes

ICD-10-CM CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:

Removed: Group 1 Paragraph information

11/17/2022: At this time the 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.

Parenteral Nutrition

PA

Parenteral Nutrition PA

Revision Effective Date: 01/01/2023

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Added: Billing information relevant to DIFs, for DOS affected by the DIF elimination

CODING GUIDELINES:

Added: Information pertaining to the need for calculation of UOS based on the treating practitioner's order

11/17/2022: At this time the 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 LCD

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.

Seat Lift Mechanisms

PA

Seat Lift Mechanisms PA

Revision Effective Date: 01/01/2023

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Added: Billing information relevant to CMNs, for DOS affected by the CMN elimination

11/17/2022: At this time the 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.

Transcutaneous Electrical Nerve Stimulators (TENS)

PA

Transcutaneous Electrical Nerve Stimulators (TENS) PA

Revision Effective Date: 01/01/2023

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Added: Billing information relevant to CMNs, for DOS affected by the CMN elimination

11/17/2022: At this time the 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/or PAs. For complete information on any topic, you must review the LCDs and/or PAs.

License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

AMA Disclaimer of Warranties and Liabilities.

CMS Disclaimer

POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

LCD and Policy Article Revisions Summary for November 17, 2022

Enteral Nutrition

LCD

PA

External Infusion Pumps

PA

High Frequency Chest Wall Oscillation Devices

LCD

PA

Immunosuppressive Drugs

PA

Osteogenesis Stimulators

PA

Oxygen and Oxygen Equipment

LCD

PA

Parenteral Nutrition

PA

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

LCD

Seat Lift Mechanisms

PA

Transcutaneous Electrical Nerve Stimulators (TENS)

PA

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