01-032 TENS Notification of Medical Review

Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review for Medicare Durable Medical Equipment (DME) of claims billed on dates of service from January 1, 2018 through December 31, 2019. This notification includes the reasons for the review, documentation that will be requested in the Additional Documentation Request (ADR) letter, and resources providers/suppliers may wish to consult when submitting claims.

Background

Transcutaneous electrical nerve stimulation (TENS) is effectively used to treat types of Chronic Intractable Pain and Acute Post-Operative Pain. In 2018, the Comprehensive Error Rate Testing (CERT) Medicare Fee-for Service improper payment report identified an improper payment rate of 93% for the TENS service. The CERT report identified 95.9% of improper payments were attributed to insufficient documentation and 0.1% related to medical necessity. Centers for Medicare and Medicaid Services (CMS) has requested the Supplemental Medical Review Contractor (SMRC) complete a review of the charges for TENS services.  The SMRC project will look at both rental and purchase of TENS units and associated supplies for improper payments in relation to insufficient documentation and medical necessity.

Reason for Review

This TENS project will focus on TENS units and associated supplies billed for Chronic Intractable Pain and Acute Post-Operative Pain. The TENS project will conduct both data analysis and medical review in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

HCPCS
  • E0720: Transcutaneous electrical nerve stimulation (TENS) device, two lead, localized stimulation
  • E0730: Transcutaneous electrical nerve stimulation (TENS) device, four or more leads, for multiple nerve stimulation
  • E0731: Form fitting conductive garment for delivery of TENS or nmes (with conductive fibers separated from the patient’s skin by layers of fabric
  • A4595: Electrical stimulator supplies, 2 lead, per month, (e.g., tens, nmes)
  • A4557: Lead wires, (e.g., apnea monitor, per pair)

Access related project details below.

Documentation Requirements

Below is a list of specific documentation requirements that will be included in each ADR to obtain the necessary documentation to perform the review. Documentation requested has been made specific to assist the provider in collecting and submitting pertinent information to decrease provider burden.

  1. Certificate of Medical Necessity (CMN), if applicable
  2. Face-to-Face Examination (F2F) related to the TENS unit and supplies billed, if applicable
  3. Clinical evaluations, physician evaluations, consultations, progress notes, physician’s office records, or other medical documentation to support medical necessity
  4. Written Order Prior to Delivery (WOPD) or Detailed Written Order (DWO), if applicable
    1. Date indicating supplier’s date of receipt of WOPD on or before date of delivery
  5. Documentation to support refill requirements were met for the supplies dispensed, if applicable
  6. Proof of Delivery (POD) for the items delivered
  7. Documentation to support the medical necessity for the TENS unit and related supplies for one of the following indications:
    1. Acute Post-operative Pain
      1. Date of surgery
      2. Nature of surgery
      3. Location and severity of pain
    2. Chronic Pain Other than Low Back Pain
      1. Location of pain
      2. Severity of pain
      3. Duration of time the beneficiary has had the pain
      4. Treatment modalities tried and/or failed
      5. Presumed etiology of the pain
      6. Reevaluation of the beneficiary at the end of trial
        1. How often the beneficiary used the TENS unit
        2. Duration of use each time TENS unit applied
        3. Results (effectiveness of therapy)
    3. Chronic Low Back Pain (CLBP)
      1. Participation in an approved study
      2. Clinicaltrials.gov identifier number, if applicable
      3. Qualifying diagnosis describing CLBP
  8. Documentation to support continued need, if applicable
  9. Documentation to support coverage that exceeds the usual utilization, if applicable
  10. For E0731: documentation that includes the brand, name, and model number of the conductive garment
    1. Documentation to support the need the for conductive garment
  11. The Advance Beneficiary Notice, if applicable
  12. Valid electronic and handwritten physician and/or clinician signatures
    1. Signature logs and signature attestation statement should be submitted when physician and/or clinician signatures are illegible

References/Resources

  • Social Security Act (SSA) Title XVIII, §§1833(e). Payment of Benefits
  • SSA, Title XVIII, §§1834(a)(11)(B)(i). Special Payment Rules for Particular Items and Services
  • SSA, Title XVIII, §§1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer
  • SSA, Title XVIII, §§1879(a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • Code of Federal Regulation Title 42, §410.38. Durable Medical Equipment: Scope and Conditions
  • 42 C.F.R., §424.5(a)(6). Basic Conditions
  • 42 C.F.R., §424.57(c)(12). Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges
  • CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 110. Durable Medical Equipment – General
  • CMS IOM, Publication 100-03, Medicare National Coverage Determinations Manual (NCD), Chapter 1, Section 10.2. Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-Operative Pain
  • CMS IOM, Publication 100-03, Medicare National Coverage Determinations Manual (NCD), Chapter 1, Section 160.7.1. Assessing Patients Suitability for Electrical Nerve Stimulation Therapy
  • CMS IOM, Publication 100-03, Medicare National Coverage Determinations Manual (NCD), Chapter 1, Section 160.13. Supplies Used in Delivery of Transcutaneous Electrical Nerve Stimulation (TENS)
  • CMS IOM, Publication 100-03, Medicare National Coverage Determinations Manual (NCD), Chapter 1, Section 160.27. Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 20, Section 10.2. Coverage Table for DME Claims
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50. Advance Beneficiary Notice of Noncoverage (ABN)
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8. No Response or Insufficient Response to Additional Documentation Requests
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4. Signature Requirements
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 4, Section 4.26. Supplier Proof of Delivery Documentation Requirements
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 4, Section 4.26.1. Proof of Delivery and Delivery Methods
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.1. Physician Orders
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.2. Verbal and Preliminary Written Orders
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.3. Detail Written Orders
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.7. Requirement of New Orders
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.8. Refills of DMEPOS Items Provided on a Recurring Basis
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.3. Certificates of Medical Necessity
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.3.1. Completing a Certificate of Medical Necessity
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.7. Documentation in the Patient’s Medical Record
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.8. Supplier Documentation
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.9. Evidence of Medical Necessity
  • Local Coverage Determination (LCD) L33802. Transcutaneous Electrical Nerve Stimulator, Effective October 1, 2015
  • Local Coverage Article (LCA) A52520. Transcutaneous Electrical Nerve Stimulator, Effective October 1, 2015
  • Local Coverage Article A55426 Standard Documentation Requirements for All Claims Submitted to DME MACs, Effective October 1, 2015

Last Updated Feb 24, 2020