Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted post-payment review of claims for Medicare Durable Medical Equipment (DME) billed on dates of service from January 1, 2018 through December 31, 2019. Below are the review results:

Background

Transcutaneous electrical nerve stimulation (TENS) units are 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) requested the Supplemental Medical Review Contractor (SMRC) complete a review of the charges for TENS services. The SMRC project looked 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 focused on TENS units and associated supplies billed for Chronic Intractable Pain and Acute Post-Operative Pain. Medical review was conducted in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• Medical Necessity
  • The medical record documentation contains an error not otherwise specified. The largest number of denials within the medical necessary categories were related to Chronic Pain other than Low Back Pain. The common rationale for the denials was the missing or limited re-evaluation after the trial period, missing etiology of pain, severity of pain, and prior treatment documentation.
• No Response to the Documentation Request
  • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8 requires providers/suppliers to respond to requests for documentation within 45 calendar days of the additional documentation request. The documentation was not submitted or not submitted timely.
• Incomplete/Insufficient Documentation
  • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8, 42 CFR 424.5(a)(6), Social Security Act 1833(e) outlines a service is to be considered reasonable and necessary when it is furnished in accordance with accepted standards of medical practice and sufficient supporting documentation is present within the medical record. This denial was applicable to Detailed Writtien Orders, Refill Requests, and Written Order Prior to Delivery requirements.

References/Resources

• Social Security Act (SSA) Title XVIII, §§1833(e).Payment of Benefits
• SSA, Title XVIII, §§1834(a)(11)(B)(ii). 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
• Patient Protection and Affordable Care Act of 2010. Public Law 111-148. Section 6407.
• 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 Dec 10, 2021