01-116 OIG Epidural Steroid Injections Notification of Medical Review

Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid Services (CMS), is conducting post-payment review of claims for Medicare Part B epidural steroid injections billed on dates of service (DOS) from January 1, 2021, through June 19, 2022. 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

Medicare Part B provides coverage for the cost of epidural steroid injection sessions when they are medically reasonable and necessary. Physicians generally perform epidural steroid injections to treat pain arising from irritations in and inflammations of the spinal nerve roots. Physicians administer these injections in the cervical, thoracic, lumbar, or sacral regions of the spine, using one of three distinct techniques, each of which involves introducing a needle into the epidural space (by a different route of entry for each technique). Per the OIG report, epidural steroid injections have been shown to reduce pain, and their use may have the effect of lowering surgical rates for specific spinal disorders. The effect of the injections on pain is palliative rather than curative and repeat injections may be beneficial in the management of pain in patients who have a favorable response to an initial injection.

The Office of Inspector General (OIG), published a report in March 2023 (A-07-21-00618), titled, Medicare Improperly Paid Physicians for Epidural Steroid Injection Sessions. The OIG conducted the current audit to determine whether Medicare made improper payments for epidural steroid injection sessions in the Medicare Administrative Contractor (MAC) jurisdictions that had defined coverage limitations. OIG findings noted that Medicare did not always pay physicians for epidural steroid injection sessions in accordance with Medicare requirements. Specifically, the OIG identified the following:

  • The MACs for the jurisdictions with a coverage limitation for the number of epidural steroid injection sessions in a 6-month period made improper payments of $2.4 million; and,
  • The MACs for the jurisdictions with a coverage limitation for the number of epidural steroid injection sessions in a 12-month period made improper payments of $1.2 million.

Reason for Review

The SMRC is tasked to perform data analysis and conduct medical record reviews on claims with CPT codes billed for epidural steroid injections to include DOS January 1, 2021, through June 19, 2022.

The SMRC will conduct medical record reviews in accordance with applicable waivers, flexibilities, statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

CPT Description
62320 Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical, or thoracic; without imaging guidance
62321 Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical, or thoracic; with imaging guidance (i.e., fluoroscopy or CT)
62322 Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar, or sacral (caudal); without imaging guidance
62323 Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar, or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT)
62325 Injection(s), including indwelling catheter placement, continuous infusion, or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, cervical, or thoracic; with imaging guidance (i.e., fluoroscopy or CT)
62326 Injection(s), including indwelling catheter placement, continuous infusion, or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar, or sacral (caudal); without imaging guidance
62327 Injection(s), including indwelling catheter placement, continuous infusion, or intermittent bolus, of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, interlaminar epidural or subarachnoid, lumbar, or sacral (caudal); with imaging guidance (i.e., fluoroscopy or CT)
64479 Injection(s), anesthetic agent(s) and/or steroid; transforaminal epidural, with imaging guidance (fluoroscopy or CT), cervical or thoracic, single level
64480 Injection(s), anesthetic agent(s) and/or steroid; transforaminal epidural, with imaging guidance (fluoroscopy or CT), cervical or thoracic, each additional level (List separately in addition to code for primary procedure)
64483 Injection(s), anesthetic agent(s) and/or steroid; transforaminal epidural, with imaging guidance (fluoroscopy or CT), lumbar or sacral, single level
64484 Injection(s), anesthetic agent(s) and/or steroid; transforaminal epidural, with imaging guidance (fluoroscopy or CT), lumbar or sacral, each additional level (List separately in addition to code for primary procedure)

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.

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

  1. Physician or Non-Physician Provider (NPP) order or evidence of intent to order.
  2. History and Physical reports (include medical history, radiologic studies, pertinent laboratory findings, and current list of medications).
  3. Medical documentation detailing prior course(s) of treatment, but not limited to, frequency and number of past injections, non-surgical or non-injection care involved, duration, and effectiveness of treatment.
  4. Initial pre-procedural comprehensive evaluation including: relevant consultations, complete pain history and procedural history (including non-invasive management), past surgical and traumatic injuries related to the spine, indicating prescribed treatment plan.
  5. Documentation of objective pain scores and/or assessments at pre and post procedure visits.
  6. Operative/procedure report including, but not limited to; procedure details, evidence of radiographic guidance (fluoroscopy or computed tomography), as well as pre and post procedure evaluation.
  7. Diagnostic tests, radiologic reports, lab results, pathology reports, and other pertinent test results and interpretations along with comparison with prior relevant studies with both normal and abnormal findings.
  8. When a diagnostic spinal nerve block is performed, post-block assessment of percentage pain relief must be documented, as outlined in the applicable Local Coverage Determination LCD/Local Policy Article ().
  9. Periodic re-evaluation including, summarization of the patient’s history and interventions, response to the procedure, rationale for ongoing interventions, and other pain management techniques.
  10. Documentation supporting the National Coverage Determination (NCD), Local Coverage Determination (LCD) or Local Policy Article.
  11. Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services).
  12. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
  13. Any other supporting/pertinent documentation
  14. 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.
  15. PLEASE NOTE: The supplier or provider is responsible for obtaining all documentation from the ordering/referring provider to ensure medical necessity criteria have been met.

References

Social Security Act (SSA), Title XI

  • § 1135 Authority to Waive Requirements During National Emergencies

Social Security Act (SSA), Title XVIII

  • § 1815(a) Payment to Providers of Services
  • § 1833(e) Payment of Benefits
  • § §1842(p)(4) Provisions Relating to the Administration of Part B
  • § 1861(aa)(5)(A) Physician assistants (PAs), Nurse Practitioners (NPs) and Clinical Nurse Specialists (CNSs)
  • § 1861(r)(1) Physician
  • § 1862(a)(1)(A) Exclusion from Coverage and Medicare as a Secondary Payer
  • § 1877(g) Blanket Waivers of Section 1877(G) of the Social Security Act Due to Declaration of COVID-19 Outbreak in the United States as a National Emergency
  • § 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 Supplementary Medical Insurance Benefits
  • § 410.3 Scope of Benefits
  • § 411.15(k)(1) Particular Services Excluded from Coverage
  • § 414.40 Coding and Ancillary Polices
  • § 424.5(a)(6) Basic Conditions

Public Law

  • Robert T. Stafford Disaster Relief and Emergency Assistance Act, Pub. L. No. 100-707, 102 Stat. 4689 (1988), Codified as Amended 42. U.S.C. § 5121. Disaster Relief and Emergency Assistance Amendments. May 2021. Retrieved from Stafford Act, as Amended – FEMA P-592 vol. 1 May 2021 external link icon.

Federal Register

  • Final Rule Volume 85, No. 66, Medicare, and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency. Effective March 1, 2020. Retrieved from 2020-06990.pdf (govinfo.gov) external link icon
  • Interim Final Rule with Comments (IFC) 85 FR 19230. Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC). Effective March 1, 2020. Retrieved from CMS-1744-IFC. external link icon

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

  • Chapter (Ch.) 15, § 80.6.1 Definitions for Ordering for Diagnostic Testing
  • Ch. 16, § 20 General Exclusions from Coverage
  • Ch. 16, § 180 Services Related to and Required as a Result of Services Which Are Not Covered Under Medicare

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

  • Ch. 12, § 20.3 Bundled Services/Supplies
  • Ch. 12, § 70 Payment Conditions for Radiology Services
  • Ch. 13, § 20 Payment Conditions for Radiology Services
  • Ch. 13, § 30 Computerized Axial Tomography Procedures
  • Ch. 23, § 20 Description of Healthcare Common Procedure Coding System (HCPCS)
  • Ch. 23, § 20.9 National Correct Coding Initiative (NCCI)
  • Ch. 30, § 30.2 Healthcare Provider or Supplier Knowledge and Liability
  • Ch. 30, § 30 Determining Liability for Disallowed Claims under § 1879
  • Ch. 30, § 40 Written Notice as Evidence of Knowledge
  • Ch. 30, § 50 Advance Beneficiary Notice of Non-coverage (ABN)

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

  • Ch. 3, § 3.2.3.2 Time Frames for Submission
  • Ch. 3, §3.2.3.3 Third-party Additional Documentation Request
  • 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, § 3.4.1.3. Diagnosis Code Requirements
  • Ch. 3, § 3.6.2 Verifying Errors

IOM, MPIM, ctd.

  • Ch. 13, § 13.5.4 Reasonable and Necessary Provisions in LCDs

CMS Coding Policies

  • National Correct Coding Initiative Edits (NCCI). NCCI Policy Manual for Medicare Services. §§ January 1, 2021, and January 1, 2022

Local Coverage Determination (LCD)

  • L33906 Epidural
  • L34807 Lumbar Epidural Steroid Injections
  • L34980 Lumbar Epidural Injections
  • L34982 Lumbar Epidural Injections
  • L35148 Lumbar Epidural Steroid Injections
  • L36521 Lumbar Epidural Injections
  • L36920 Epidural Injections for Pain Management

Local Coverage Article (LCA)

  • A56469 Billing and Coding for Lumbar Epidural Steroid Injections (ESI)
  • A56651 Billing and Coding: Epidural
  • A56681 Billing and Coding for Epidural Injections for Pain
  • A56721 Billing and Coding for Lumbar Epidural Steroid Injections
  • A57202 Billing and Coding: Lumbar Epidural Injections
  • A57203 Billing and Coding: Lumbar Epidural Injections
  • A57555 Billing and Coding for Lumbar Epidural Injections

Other

  • Medicare Learning Network, MLN Matters 905364. Complying with Medicare Signature Requirements. April 2022
  • Medicare Learning Network, MLN Matters MM6563. Billing for Services Related to Voluntary Uses of Advance Beneficiary Notices of Noncoverage (ABNs). Effective April 1, 2010

Last Updated Feb 14, 2024