Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted post-payment review of claims for Medicare Part B billed on dates of service from January 1, 2020, through December 31, 2020. Below are the review results:

Background

In October of 2021, the Office of the Inspector General (OIG) released a report entitled “Medicare Overpaid More Than $636 Million For Neurostimulator Implantation Surgeries” (A-01-18-00500). The OIG found that more than 40 percent of the health care providers covered by the audit did not comply with Medicare requirements when billing for neurostimulator implantation surgeries. Based on the sample results, the OIG estimated during calendar years 2016 and 2017, providers received $636 million in unallowable Medicare payments associated with neurostimulator implantation surgeries. In addition, beneficiaries paid $54 million in related unnecessary copays and deductibles.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical record review for neurostimulator implantation services. The SMRC performed medical record review on supporting documentation, to determine if services were medically necessary. The SMRC conducted medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• Insufficient or missing psychological screening:
  • Refer to 42 Code of Federal Regulations (CFR) 411.15(k)(1), Social Security Act (SSA) Title XVIII, Section 1862(a)(1)(A), Internet Only Manual (IOM) Publication (Pub.) 100-08, Chapter 3, Section 3.6.2.2. National Coverage Determination (NCD) for Electrical Nerve Stimulators, Publication (Pub) 100-03 (160.7). Also, please see the Medicare Administrative Contractor (MAC) Local Coverage Determination (LCD) and/or Local Coverage Article (LCA) if applicable. In addition, please refer to NCD 160.7 Electrical Nerve Stimulators, that states that in order for a neurostimulator implantation to be covered, a psychological screening must be submitted. The documentation did not include a psychological screening prior to implantation of the spinal cord stimulator.
• No response to the documentation request:
  • Refer to Internet-only Manual Pub 100-08, Chapter 3, Section 3.2.3.8, 42 CFR 424.5(a)(6), Social Security Act 1862(a)(1)(A), Social Security Act 1833(e). The PIM 100-08, 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 for the dates of service under review. The documentation was not submitted or not submitted timely.
• Insufficient evidence of a multidisciplinary team:
  • Refer to 42 Code of Federal Regulations (CFR) 411.15(k)(1), Social Security Act (SSA) Title XVIII, Section 1862(a)(1)(A), Internet Only Manual (IOM) Publication (Pub.) 100-08, Chapter 3, Section 3.6.2.2. National Coverage Determination (NCD) for Electrical Nerve Stimulators, Publication (Pub) 100- 03 (160.7). In addition, please see the Medicare Administrative Contractor (MAC) Local Coverage Determination (LCD) and/or Local Coverage Article (LCA) if applicable. An NCD 160.7 Electrical Nerve Stimulators, also states that in order for a neurostimulator implantation to be covered, a multidisciplinary team must be established. The documentation submitted did not include evidence of a multidisciplinary team approach prior to implantation of the spinal cord stimulator.

References

Social Security Act (SSA), Title XVII

• § 1815(a) Payment to Providers of Services
• § 1833(e) Payment of Benefits
• § 1842(p)(4) Provisions Relating to the Administration of Part B
• §§ 1861(e), (s)(2)(B)(K) Miscellaneous Provisions
• § 1862(a)(1)(A) Exclusions from Coverage and Medicare as Secondary Payer
• §§ 1869(f)(1)(B), (f)(2)(B) Determinations; Appeals
• § 1879(a)(1) Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
• §§1893(f)(7)(A)(B) (i-iv), (h)(4)(B) Medicare Integrity Program

42 Code of Federal Regulations (CFR)

• § 410.3 Scope of benefits
• § 411.15(k)(1) Particular services excluded from coverage
• § 411.404 Criteria for determining that a beneficiary knew that services were excluded from coverage as custodial care or as not reasonable and necessary
• § 411.406 Criteria for determining that a provider, practitioner, or supplier knew that services were excluded from coverage as custodial care or as not reasonable and necessary
• §§ 424.5(a)(6) Basic Conditions
• § 482.24(c) Conditions of participation: Medical record services

Internet Only Manual (IOM), Medicare National Coverage Determinations Manual (NCD), Publication (Pub.) 100-03

• Chapter (Ch.) 1, § 160.2 Treatment of Motor Function Disorders with Electric Nerve Stimulation
• Ch. 1, §160.7 Electrical Nerve Stimulators
• Ch. 1, § 160.7.1 Assessing Patient’s Suitability for Electrical Nerve Stimulation Therapy
• Ch. 1, § 160.18 Vagus Nerve Stimulation (VNS)
• Ch. 1, § 160.24 Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease
• Ch. 1, § 230.18 Sacral Nerve Stimulation for Urinary Incontinence

IOM, Medicare Benefit Policy Manual (MBPM), Pub. 100-02

• Ch. 6, § 20 Outpatient Hospital Services
• Ch. 14, §§10-40 Medical Devices
• Ch. 15, § 260 Ambulatory Surgical Center Services
• Ch. 16, §§ 10 and 20 Services Not Reasonable and Necessary

IOM, Medicare Claims Processing Manual (MCPM), Pub. 100-04

• Ch. 1, General Billing Requirements
• Ch. 4, § 20 Outpatient Hospital Services
• Ch. 12, § 20.3 Bundled Services/Supplies
• Ch. 12, § 90.3 Physician’s Service Performed in Ambulatory Surgical Centers (ASC)
• Ch. 14, § 10 General
• Ch. 23, § 20.9 National Correct Coding Initiative (NCCI)
• Ch. 30, § 30 Determining Liability for Disallowed Claims Under § 1879
• Ch. 30, §§ 40 and 50 Advance Beneficiary Notice of Non-coverage (ABN)
• Ch. 32, § 40 Sacral Nerve Stimulation
• Ch. 32, § 50 Deep Brain Stimulation for Essential Tremor and Parkinson’s Disease
• Ch. 32, § 200 Billing Requirements for Vagus Nerve Stimulation (VNS)

IOM, Medicare Program Integrity Manual (MPIM), Pub. 100-08

• Ch. 3, § 3.2.3.2 Time Frames for Submission
• Ch. 3, § 3.2.3.4 Additional Documentation Request Required and Optional Elements
• Ch. 3, § 3.2.3.8 No Response or Insufficient Response to Additional Documentation Requests
• Ch. 3, § 3.3.2.1 Documents on Which to Base a Determination
• Ch. 3, § 3.3.2.4 Signature Requirements
• Ch. 3, § 3.3.3 Reviewing Claims in the Absence of Polices and Guidelines
• Ch. 3, § 3.6 Determinations Made During Medical Review
• Ch. 3, § 13.5.4 Reasonable and Necessary Provisions in LCDs

Local Coverage Determination (LCD)

• L34328 Peripheral Nerve Stimulation
• L35136 Spinal Cord Stimulators for Chronic Pain
• L35450 Spinal Cord Stimulation (Dorsal Column Stimulation)
• L36035 Spinal Cord Stimulation for Chronic Pain
• L36204 Spinal Cord Stimulators for Chronic Pain
• L37360 Peripheral Nerve Stimulation
• L37632 Spinal Cord Stimulators for Chronic Pain
• L38276 Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Local Coverage Article (LCA)

• A55530 Billing and Coding: Peripheral Nerve Stimulation
• A55531 Billing and Coding: Peripheral Nerve Stimulation
• A57023 Billing and Coding: Spinal Cord Stimulation (Dorsal Column Stimulation)
• A57709 Billing and Coding: Spinal Cord Stimulation for Chronic Pain
• A57791 Billing and Coding: Spinal Cord Stimulators for Chronic Pain
• A57792 Billing and Coding: Spinal Cord Stimulators for Chronic Pain
• A56876 Billing and Coding: Spinal Cord Stimulators for Chronic Pain
• A58075 Billing and Coding: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Last Updated Aug 15, 2023