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

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 lower 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

In response to the OIG report, the SMRC was 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 conducted medical record reviews in accordance with applicable waivers, flexibilities, statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• Medical Necessity for Overutilization
  • The documentation provided does not support the medical necessity for this number of services or items within this timeframe. Social Security Act (SSA) 1862, Internet Only Manual (IOM), 100-08, Medicare Program Integrity Manual (MPIM) Chapter (Ch.) 3, Section 3.6.2.2, identifies that claims will be denied if the documentation submitted, based on the coverage criteria, does not support medical necessity for the service performed. The medical record demonstrated the providers exceeded the number of allowable sessions in accordance with the applicable LCD. Providers billed more injections than allowed per session per spinal region in a rolling 6-or 12-month period.
• Non-Response to the ADR
  • The requested records were not received. Code of Federal Regulations (CFR) Title 42, 424.5(a)(6), Social Security Act 1862(a)(1)(A), Social Security Act 1833(e), IOM, Publication (Pub.) 100-08, MPIM, Ch. 3, Section 3.2.3.8, this requires providers to respond to requests for documentation within 45 calendar days of the additional documentation request. The requested documentation was not submitted or not submitted timely to support reasonable and necessary criteria for epidural steroid injections.
• Incomplete or Insufficient Documentation
  • The documentation submitted was incomplete and/or insufficient. Code of Federal Regulations (CFR) Title 42, 424.5(a)(6), SSA 1862(a)(1)(A), SSA 1833(e), states that claims will be denied if the medical record lacks the necessary information to support whether the appropriate coverage requirements were met. The medical record was found to be incomplete or missing required elements as outlined in the appropriate coverage policy, such as a physical examination, complete pain history, failure of four weeks of noninvasive therapy, follow-up response to previous injections, and detailed operative reports to support the services being billed.

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

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)
• 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 .

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.
• 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 Dec 6, 2024