01-072 Neurostimulator Implantation Notification of Medical Review

Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC), is conducting post-payment review of claims for Medicare Part B of A and Part B neurostimulator implantation claims billed on dates of service from January 1, 2020, through December 31, 2020. 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

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. On the basis of 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

The SMRC is tasked with performing claim review on a sample of neurostimulator implantation claims from January 1, 2020, through December 31, 2020. The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities, statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

CPT Description
61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling, with connection to a single electrode array
61886 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling, with connection to 2 or more electrode arrays
63685 Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling

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.

Providers/suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review.

  1. Physician/Non-Physician (NPP) order or evidence of intent to order
  2. Operative/procedure report including all physician, anesthesia, peri-operative and nursing notes, and medication administration records to support services billed is reasonable and necessary
  3. Beneficiary’s medical records (which may include practitioner medical records, hospital records, nursing home records, home care nursing notes) that support the item(s) provided is/are reasonable and necessary
  4. Physician, Practitioner, nurse, and ancillary progress notes
  5. Documentation and description of the devices, implants, biological products used in the procedure
  6. Documentation of the psychological screening and evaluation
  7. Documentation of the physical assessment and evaluation
  8. Documentation of a diagnosis by a multidisciplinary team prior to implantation
  9. Documentation of the previously tried and failed treatment, such as, medications, physical therapy, surgery or psychological therapy; or documentation that supports that these modalities were considered unsuitable or contraindicated
  10. Documentation to support National Coverage Determination (NCD), Local Coverage Determination (LCD) and/or Policy Article
  11. List of all non-standard abbreviations or acronyms used, including definitions
  12. Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services)
  13. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
  14. Any other supporting documentation
  15. If medical record documentation is submitted via esMD; Beneficiary identification, date of service, and provider of the service should be clearly identified on each page of the submitted documentation
  16. PLEASE NOTE: It is the responsibility of the provider to obtain all documentation from the ordering/referring provider to ensure medical necessity criteria have been met

References/Resources

Title XVII of the Social Security Act (SSA)

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

Title 42 of the Code of Federal Regulations (CFR)

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

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

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

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

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

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

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

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

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

Local Coverage Determination (LCD)

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

Local Coverage Article (LCA)

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

Last Updated Apr 4, 2022