01-019 Spinal Cord Stimulator Notification of Medical Review

Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of claims for Medicare Part B, spinal cord stimulator (SCS), billed on dates of service from January 1, 2018, through December 31, 2018. 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

The Office of Inspector General (OIG), under Management Implication Report (MIR) 12-009, titled “Spinal Cord Stimulators”, noted vulnerabilities in the Medicare payment process that allowed excessive billing for implantable spinal cord stimulators (SCSs) that did not meet the coverage criteria as outlined in Medicare National Coverage Determinations (NCD) Manual, Publication 100-03, Chapter 1, Part 2, Section 160.7. The OIG found a pain management practice had received millions of dollars in Medicare payments, over several years, for implanting SCSs. The provider performed and billed for permanent SCSs without the prerequisite trial modalities or trial demonstration using a temporary stimulator, as specified in the NCD.

In response to the MIR, the CMS directed the prior SMRC, Strategic Health Solutions, to perform medical record review of SCS claims. Based on the findings, additional medical review was recommended.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical review. Noridian will complete medical record review on claims in accordance with applicable statutory, regulatory and sub-regulatory guidance.

Claim Sample Detail

TOB/Specialty Code CPT
  • 13X: Hospital Outpatient
  • 85X: Critical Access Hospital
  • 49: Ambulatory Surgical Center
  • 63650: Percutaneous implantation of neurostimulator electrode array, epidural
  • 63655: Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural
  • 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 letter, to obtain the necessary documentation to perform the medical record review. Documentation requested has been made specific to assist the supplier in collecting and submitting pertinent information thereby reducing provider burden. Additionally, the specific requirements will aid in clarity on scope of review to allow the MAC redeterminations teams to process the request accordingly and prevent overturning of correct decisions.

  1. Pre-procedure history and physical examination report(s)
  2. Physician order for the procedure/device
  3. Documentation of the screening, evaluation and diagnosis by a multidisciplinary team prior to implantation (such screening must include psychological, as well as physical evaluation)
  4. 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
  5. Documentation of an effective spinal cord stimulator (SCS) trial prior to permanent implantation
  6. Operative/procedure reports, including all physician, anesthesia, peri-operative and nursing notes, and medication administration records to support services billed on the requested date of service
  7. Advance Beneficiary Notice of Noncoverage (ABN), if applicable
  8. Legible handwritten physician and/or clinician signatures
    1. Signature logs and Signature Attestation Statement should be submitted when physician and/or clinician signatures are illegible
  9. Valid electronic physician and/or clinician signatures
    1. If an electronic health record is used, the Electronic Order Signature Process Form should be submitted to verify provider’s Electronic Ordering System is secure
  10. List of any abbreviations or acronyms used
  11. Any and all other documentation to support the medical necessity of the item/services billed.

References/Resources

  • Social Security Act (SSA), Title XVIII, §§1833(e). Payment of Benefits
  • SSA, Title XVIII, §§1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer
  • SSA, Title XVIII, §§1869(f)(1)(B). Determinations; Appeals
  • SSA, Title XVIII, §§1879(a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • SSA, Title XVIII, §§1893(f)(7)(A)(B)(i-iv). Medicare Integrity Program
  • SSA, Title XVIII, §§1893(h)(4)(B). Medicare Integrity Program
  • 42 C.F.R. §411.4. Services for which neither the beneficiary nor any other person is legally obligated to pay
  • 42 C.F.R. §404. Criteria for determining that a beneficiary knew that services were excluded from coverage as custodial care or as not reasonable and necessary
  • 42 C.F.R. §424.5(a)(6). Basic Conditions
  • 42 C.F.R. §24(c). Condition of Participation: Medicare Record Services
  • CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 16, Section 20. Services Not Reasonable and Necessary
  • CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 20. Hospital Services Covered Under Part B
  • CMS IOM, Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, Section 160.7. Electrical Nerve Stimulators
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 12, Section 20.3. Bundled Services/Supplies
  • CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 30, Section 40.3.6 and 40.3.6.4. Routine Notice Prohibition & ABN Prohibition Exceptions
  • 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 3.3.2.1. Documents on which to Base a Determination
  • 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 3, Section 3.6.2.2. Reasonable and Necessary Criteria
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.5. Denial Types
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4. Reasonable and Necessary Provisions in LCDs
  • Local Coverage Determination (LCD) L34556. Spinal Cord Stimulators for Chronic Pain. Effective 10/01/2015-February 15, 2018
  • LCD L35136. Spinal Cord Stimulators for Chronic Pain. Effective 10/01/2015-present
  • LCD L35450. Spinal Cord Stimulation (Dorsal Column Stimulation). Effective 10/01/2015-December 31, 2018
  • LCD L36035. Spinal Cord Stimulation for Chronic Pain. Effective 10/01/2015-present
  • LCD L36204. Spinal Cord Stimulation for Chronic Pain. Effective 06/01/2016-present
  • LCD L36879. Spinal Cord Stimulators for Chronic Pain. Effective 03/01/2017-January 28, 2018.
  • LCD L37632. Spinal Cord Stimulators for Chronic Pain. Effective 01/28/2018-present
  • Local Coverage Article A54817. Spinal Cord Stimulators for Chronic Pain (code guide). Effective 01/01/2016-present

 

Last Updated Aug 12, 2019