LCD

Ankle-Foot/Knee-Ankle-Foot Orthosis LCD

Revision Effective Date: 04/01/2025

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Added: HCPCS codes L1933 and L1952 to the HCPCS codes that describe ankle-foot orthoses (AFOs) that are covered for ambulatory beneficiaries with weakness or deformity of the foot and ankle who meet specified criteria

HCPCS CODES:

• Revised: Long descriptions of HCPCS codes L1932, L1951, and L1971
• Added: HCPCS codes L1933 and L1952

04/03/2025: 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.

PA

Ankle-Foot/Knee-Ankle-Foot Orthosis PA

Revision Effective Date: 04/01/2025

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

• Added: "Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by the treating practitioner." as clarification
• Added: HCPCS codes L1933 and L1952 to the prefabricated orthoses HCPCS codes

CODING GUIDELINES:

• Added: A row to the table that pertains to corresponding sets of HCPCS codes; the added row contains "L1932" in Column I and "L1933" in Column II
• Added: A row to the table that pertains to corresponding sets of HCPCS codes; the added row contains "L1951" in Column I and "L1952" in Column II
• Added: HCPCS codes L1933 and L1952 to the HCPCS codes for ankle-foot orthoses that extend well above the ankle (usually to near the top of the calf) and are fastened around the lower leg above the ankle
• Revised: Coding guidelines for HCPCS codes L1932, L1951, and L1971
• Added: Coding guidelines for HCPCS codes L1933 and L1952

CODING VERIFICATION REVIEW:

• Added: Coding verification review information for HCPCS code L1952, effective for dates of service on or after April 1, 2025

04/03/2025: 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.

LCD

Bowel Management Devices LCD

Revision Effective Date: 04/01/2025

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Revised: "§13.7.1" to "§13.2.3 and 13.5.2" in regard to the Centers for Medicare & Medicaid Services (CMS) Program Integrity Manual (Internet-only Manual 100-08), Chapter 13
• Revised: "Rectal catheters/tubes and related collection systems will be denied as statutorily non-covered (no benefit – see related Policy Article)." to "Fecal collection systems and rectal catheters/tubes used with such systems will be denied as statutorily non-covered (no benefit – see related Policy Article)." as clarification
• Revised: "Enema systems (gravity and manual pump), codes A4458 and A4459 respectively, will be denied as statutorily non-covered (no benefit – see related Policy Article)." to "Enema systems (gravity) coded A4458, will be denied as statutorily non-covered (no benefit – see related Policy Article)."

HCPCS CODES:

• Revised: Long descriptions of HCPCS codes A4453 and A4459

04/03/2025: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to manual citations, nonsubstantive updates to existing noncoverage language, and non-discretionary updates per CMS HCPCS coding determinations.

PA

Bowel Management Devices PA

Revision Effective Date: 04/01/2025

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

• Revised: "Rectal inserts and electrical incontinence aids are covered under the Prosthetic Devices benefit (Social Security Act §1861(s)(9))." to "Rectal inserts, electrical incontinence aids, and transanal irrigation (TAI) systems (which are comprised of a TAI device and rectal catheter that has a sealing function [balloon or cone-based]) are covered under the Prosthetic Devices benefit (Social Security Act §1861(s)(9))."
• Revised: "Manual pump enema systems (e.g., Peristeen - Coloplast, Minneapolis, MN) or gravity-administered enema systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability." to "Gravity-administered enema systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability."
• Revised: "Rectal catheters/tubes and related collection systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability." to "Fecal collection systems and rectal catheters/tubes used with such systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability." as clarification

CODING GUIDELINES:

• Revised: "HCPCS codes A4458 (ENEMA BAG WITH TUBING, REUSABLE) and code A4459 (MANUAL PUMP ENEMA SYSTEM, INCLUDES BALLOON, CATHETER AND ALL ACCESSORIES, REUSABLE, ANY TYPE) describe devices used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management." to "HCPCS code A4458 (ENEMA BAG WITH TUBING, REUSABLE) describes a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management."
• Revised: "Fluid is instilled either via gravity or a manual pump." to "Fluid is instilled via gravity."
• Revised: "The Peristeen transanal irrigation system is a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management. The system consists of an enema bag, a rectal catheter with an inflatable balloon and a pump." to "The Peristeen transanal irrigation system is a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence in patients with neurogenic bowel dysfunction. The system consists of a water reservoir, a screw top, a disposable rectal catheter with an inflatable balloon, a control unit, tubing, and a pump."
• Revised: Billing information for the Peristeen transanal irrigation system, by changing "dates of service on or after January 1, 2015" to "dates of service on or after January 1, 2015 through March 31, 2025" and by updating the format of the information to a bulleted list
• Added: Billing information for the Peristeen transanal irrigation system for claims with dates of service on or after April 1, 2025

04/03/2025: 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.

LCD

External Breast Prostheses LCD

Revision Effective Date: 04/01/2025

HCPCS CODES:

• Removed: HCPCS code L8010 from Group 1 codes

04/03/2025: 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.

PA

External Breast Prostheses PA

Revision Effective Date: 04/01/2025

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

• Removed: "A mastectomy sleeve (L8010) is denied as noncovered, since it does not meet the definition of a prosthesis."

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

• Added: "Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by the treating practitioner." as clarification

04/03/2025: 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.

PA

Eye Prostheses PA

Revision Effective Date: 01/01/2020

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

• Added: "Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by the treating practitioner." as clarification

04/03/2025: 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.

PA

Facial Prostheses PA

Revision Effective Date: 01/01/2020

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

• Added: "Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by the treating practitioner." as clarification

04/03/2025: 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.

PA

Knee Orthoses PA

Revision Effective Date: 01/01/2025

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

• Added: "Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by the treating practitioner." as clarification

04/03/2025: 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.

LCD

Lower Limb Prostheses LCD

Revision Effective Date: 04/01/2025

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

HCPCS CODES:

• Added: HCPCS code L5827

BIBLIOGRAPHY:

• Removed: Bibliography information, due to not being applicable to the non-discretionary changes

04/03/2025: 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.

PA

Lower Limb Prostheses PA

Revision Effective Date: 04/01/2025

CODING GUIDELINES:

• Revised: Coding guidelines for HCPCS codes L5671 and L5647, as clarification
• Removed: Coding guideline for the Infinite Socket, as clarification
• Revised: "Addition codes for endoskeletal knee-shin systems (L5610, L5611, L5613, L5615, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840, and L5841) are considered an upgrade to the knee-shin system." to "Addition codes for endoskeletal knee-shin systems (L5610, L5611, L5613, L5615, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5827, L5828, L5830, L5840, and L5841) are considered an upgrade to the knee-shin system."
• Revised: "A single addition code can fully describe a complete knee-shin system and thus the use of two codes (L5610, L5611, L5613, L5615, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840, and L5841) would be considered incorrect coding (unbundling)." to "A single addition code can fully describe a complete knee-shin system and thus the use of two codes (L5610, L5611, L5613, L5615, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5827, L5828, L5830, L5840, and L5841) would be considered incorrect coding (unbundling)."
• Revised: "L5925, L5930, L5845, L5848, L5850, L5856, L5857, L5858, and L5859 are additional features and/or functions that do not describe a complete endoskeletal knee-shin system and must be used in combination with an L-code for a knee-shin system (L5610, L5611, L5613, L5615, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840, and L5841)." to "L5925, L5930, L5845, L5848, L5850, L5856, L5857, L5858, and L5859 are additional features and/or functions that do not describe a complete endoskeletal knee-shin system and must be used in combination with an L-code for a knee-shin system (L5610, L5611, L5613, L5615, L5616, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5827, L5828, L5830, L5840, and L5841)."
• Added: Coding guideline for HCPCS code L5827

04/03/2025: 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.

PA

Orthopedic Footwear PA

Revision Effective Date: 11/01/2023

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

• Added: "Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by the treating practitioner." as clarification

04/03/2025: 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.

PA

Spinal Orthoses: TLSO and LSO PA

Revision Effective Date: 01/23/2024

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

• Added: "Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by the treating practitioner." as clarification

04/03/2025: 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.

LCD

Wheelchair Options/Accessories LCD

Revision Effective Date: 04/01/2025

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

• Revised: HCPCS noted as swingaway, retractable, or removable hardware, from "(E1028)" to "(E1028, E1032)"

HCPCS CODES:

• Revised: Long description for HCPCS code E1028
• Revised: Long description for HCPCS code E1005, for dates of service on or after January 1, 2004
• Added: HCPCS codes E1022, E1023, and E1032 to Group 9 Codes

04/03/2025: 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.

PA

Wheelchair Options/Accessories PA

Revision Effective Date: 04/01/2025

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

• Revised: HCPCS noted as swingaway, retractable, or removable hardware, from "(E1028)" to "(E1028, E1032)"
• Added: "A wheelchair transportation securement system (E1022) and a wheelchair transit securement system (E1023) are non-covered as they do not meet the definition of DME."

MODIFIERS:

• Revised: "KX, GA, GY, AND GZ MODIFIERS:" to "KX, GA, GY, GZ, LT, and RT MODIFIERS:"
• Added: RT and LT modifier information (relocated from the CODING GUIDELINES section)

CODING GUIDELINES:

• Removed: RT and LT modifier information
• Revised: Coding guideline for HCPCS code E1028
• Added: Coding guideline for HCPCS code E1032
• Added: "For initial claims or new rental periods for swingaway, retractable, or removable mounting hardware for wheelchair accessories described by joysticks or other drive control interfaces, with dates of service on or after April 1, 2025, suppliers must use HCPCS code E1032."
• Added: "If the rental period for the swingaway, retractable, or removable mounting hardware for wheelchair accessories described by joysticks or other drive control interfaces began prior to April 1, 2025, then suppliers must use HCPCS code E1028 for ongoing claims in the rental period."
• Revised: Information in the table that pertains to codes included in the allowance of other codes; in the table, "E1028" was revised to "E1032" in Column II of the row that contains "E2325" in Column I

04/03/2025: 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.

LCD

Wheelchair Seating LCD

Revision Effective Date: 04/01/2025

HCPCS CODES:

• Revised: Long description for HCPCS code E1028
• Added: HCPCS codes E1033 and E1034 to Group 3 Codes

04/03/2025: 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.

PA

Wheelchair Seating PA

Revision Effective Date: 04/01/2025

MODIFIERS:

• Revised: "GA, GY, AND GZ MODIFIERS:" to "GA, GY, GZ, LT, and RT MODIFIERS:"
• Added: RT and LT modifier information (relocated from the CODING GUIDELINES section)

CODING GUIDELINES:

• Revised: "Code E1028 (swingaway or removable mounting hardware upgrade) may be billed in addition to codes E0953, E0955, E0956, E0957. It must not be billed in addition to code E0960. It must not be used for mounting hardware related to a wheelchair seat cushion or back cushion code." to "Code E1028 (swingaway or removable mounting hardware upgrade) may be billed in addition to codes E0953 and E0957. It must not be billed in addition to codes E0955, E0956 or E0960. Code E1028 must not be used for mounting hardware related to a wheelchair seat cushion or back cushion code."
• Added: Coding guidelines for HCPCS codes E1033 and E1034
• Added: "For initial claims or new rental periods for swingaway, retractable, or removable mounting hardware for wheelchair accessories described by headrests and lateral trunk or hip supports, with dates of service on or after April 1, 2025, suppliers must use HCPCS code E1033 and E1034, respectively."
• Added: "If the rental period for the swingaway, retractable, or removable mounting hardware for wheelchair accessories described by headrests or lateral trunk or hip supports began prior to April 1, 2025, then suppliers must use HCPCS code E1028 for ongoing claims in the rental period. In this scenario, if an E0955 or E0956 rental period also began prior to April 1, 2025 and is still in a rental period after April 1, 2025, then the E0955 or E0956 will continue to be billed with the E1028."
• Removed: RT and LT modifier information

04/03/2025: 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.