Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of claims for Medicare profession services billed on dates of service from January 1, 2023, through December 31, 2023. 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

Hyaluronic acid (HA) is a glycosaminoglycan molecule providing viscoelastic properties of synovial fluid and is found in joints within the body such as the knee. Synovial fluid lubricates joints and absorbs shock. Osteoarthritis (OA) is characterized by chronic low-grade inflammation with elevated levels of inflammatory mediators as well as reduction in HA. This leads to damage to cartilage, ultimately causing injury to bone, ligaments, synovium, capsule and muscle leading to pain. As the OA advances, damage to the joint can be diagnosed with radiologic evidence. Radiologic evidence may include, but is not limited to, joint space narrowing, subchondral sclerosis, osteophytes, or sub-chondral cysts.

Viscosupplementation is a treatment injecting high molecular weight fluid with HA into the affected joint. The HA may have anti-inflammatory properties and thus reduce cartilage destruction, pain, swelling, and improve joint mobility. Conservative therapy and radiologic evidence aid in determination of initiating viscosupplementation therapy.

Reason for Review

This topic has been identified as a potential vulnerability by the Office of Inspector General (OIG) and has been placed is on the OIG workplan. The SMRC is tasked to perform data analysis and conduct medical record reviews on Knee Injection with Hyaluronic Acid claims. The SMRC will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance for dates of service January 1 – December 31, 2023.

Claim Sample Detail

Access related project details below.

• Documentation Requirements
• References

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

1. The clinical indication/medical necessity for the injection including the number and location of injections as well as dosages and medications used.
2. Any medical records from the place of services rendered, physician history and progress notes, diagnoses/conditions, physicals, diagnostic testing (including MRI, CT results, etc.), lab tests and any other pertinent information to document the medical necessity.
3. Documentation to support trial of conservative therapy, or failure, or contraindication to conservative therapy prior to hyaluronan knee injections within the medical record and response to prior therapies.
4. Detailed operative or procedure note to support Hyaluronic Acid injection.
5. Documentation to support Local Coverage Determination (LCD) and Policy Article Medical documentation detailing prior course of treatment. This is not limited to, frequency and number of past injections, non-surgical and non-injection care involved, duration and effectiveness of treatment.
6. Documentation to support effectiveness and medical necessity of repeat series of hyaluronan knee injections for patients who have responded to a prior series, and at least six months have elapsed since the prior series of injections.
7. Providers/suppliers are encouraged to review the documentation prior to submission, to ensure that signature information is available when authenticity is not conclusively documented. Please include a signature log or signature attestation for any missing or illegible signature within the medical record.
8. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)
9. Any other supporting/pertinent documentation
10. 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.
11. 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
• §1861(s) Medical and Other Health Services
• §1862(a)(1)(A) Exclusion from Coverage and Medicare as a Secondary Payer
• §1862(a)(7) Exclusions from Coverage and Medicare as Secondary Payer
• §1877(g) Limitation on Certain Physician Referrals
• §1879(a)(1) Limitation on Liability of Beneficiary where Medicare Claims are Disallowed

42 Code of Federal Regulations (CFR)

• §410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
• §411.15(k)(1) Any services that are not reasonable and necessary
• §424.5(a)(6) Conditions for Medicare Payment-Basic Condition, Sufficient Information

Federal Register

• Notices Volume 83, No. 242, Intent to Consider the Appropriate Classification of Hyaluronic Acid Intra-Articular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence. Effective December 18, 2018. Retrieved from 2018-27351.pdf

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

• Chapter (Ch.) 15, §50 Drugs and Biologicals
• Ch. 15, §50.3 Incident-to Requirements
• Ch. 15, §50.4.1 Approved Use of Drug
• Ch. 16, General Exclusion from Coverage

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

• Ch. 1, General Billing Requirements
• Ch. 17, §10 Payment Rules for Drugs and Biologicals
• Ch. 17, §40 Discarded Drugs and Biologicals
• Ch. 17, §90.2 Drugs, Biologicals, and Radiopharmaceuticals
• Ch. 23, §20.9 National Correct Coding Initiative (NCCI)
• Ch. 26, §10.5 Place of Service Codes (POS) and Definitions
• Ch. 30, §50 Advance Beneficiary Notice of Non-coverage (ABN)

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

• Ch.3, Verifying Potential Errors and Taking Corrective Actions
• Ch. 13, §13.5.4 Reasonable and Necessary Provisions in LCDs

CMS Coding Policy

• NCCI Policy Manual for Medicare Services, Ch. 4 Surgery: Musculoskeletal System Effective January 1, 2020

Local Coverage Determinations (LCDs)

• L39260 Hyaluronic Acid Injections for Knee Osteoarthritis
• L39529 Intraarticular Knee Injections of Hyaluronan

Local Coverage Articles (LCAs)

• A56157 Billing and Coding: Intraarticular Knee Injections of Hyaluronan
• A59030 Billing and Coding: Hyaluronic Acid Injections for Knee Osteoarthritis

Other

• American Medical Association (AMA), Current Procedural Terminology (CPT) CPT® (Current Procedural Terminology) | AMA
• Medical Coding – Medical Billing – Medical Auditing – AAPC
• MLN13056 New JZ Claims Modifier for Certain Medicare Part B Drugs, January 1, 2023
• National Library of Medicine (NIH). Knee osteoarthritis: pathophysiology and current treatment modalities. October 5, 2018. Retrieved from https://pubmed.ncbi.nlm.nih.gov/30323653/
• National Library of Medicine (NIH). Knee osteoarthritis: pathophysiology and current treatment modalities. October 5, 2018. Retrieved from https://pubmed.ncbi.nlm.nih.gov/30323653/

Last Updated Jan 10, 2025