Transcutaneous Electrical Nerve Stimulators (TENS)

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: 11/20/2021
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Criterion III Chronic Lower Back Pain (CLBP) due to coverage expired June 7, 2015 under NCD 160.27
Added: Not reasonable and necessary statement in accordance with NCD 160.27
CODING INFORMATION:
Removed: Modifier Q0 under HCPCS Modifiers section
APPENDICES:
Removed: CLBP clinical trial references


10/7/2021: In accordance with NCD 160.27, coverage of TENS for CLBP is no longer available under Coverage with Evidence Development. Per the NCD, TENS is not reasonable and necessary for the treatment of CLBP under section 1862(a)(1)(A) of the Act. As a result, the DME MACs are removing this requirement as a non-discretionary change to the LCD, per the Program Integrity Manual, Chapter 13, §13.2.4.

Revision Effective Date: 01/01/2020:
 COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
 Revised: “physician” to “practitioner”
 Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
 Added: Statement to refer to ICD-10 code list in the LCD-related Policy Article
 Revised: “physician” to “treating practitioner”
 GENERAL:
 Revised: Order information as a result of Final Rule 1713
 REFILL REQUIREMENTS:
 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”
 DOCUMENTATION REQUIREMENTS:
 Revised: “physician’s” to “treating practitioner’s”
 GENERAL DOCUMENTATION REQUIREMENTS:
 Revised: “Prescriptions (orders)” to “SWO”


02/27/2020: 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.

Revision Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
 Removed: Statement to refer to diagnosis code section below
 Added:
Refer to Covered ICD-10 Codes in the LCD-related Policy Article
 ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
 Moved: All diagnosis codes 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

Revision Effective Date: 10/01/2017
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: New ICD-10 codes
 Deleted: Non-valid ICD-10 (effective 10/01/2015)


11/30/2017: 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:
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 reference under Miscellaneous
Removed: PIM reference 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: 10/31/2014
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 for WOPD to make consistent with ACA 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
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
ICD-10 diagnosis codes updated based on ICD-10 Conversion/Coding Infrastructure Revisions/ICD-9 Updates to National Coverage Determinations (NCDs) Maintenance CR