01-133 Knee Injections with Hyaluronic Acid Findings of Medical Review
Noridian Healthcare Solutions, LLC, (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid (CMS), has conducted post-payment review of Part B Medicare knee injections with hyaluronic acid claims with dates of service from January 1, 2023, through December 31, 2023. Below are the review results:
| Project ID | Project Title | Error Rate | No Response to ADR Denials |
|---|---|---|---|
| 01-133 | Knee Injections with Hyaluronic Acid | 73% | 25% |
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
The SMRC was tasked to perform data analysis and conduct medical record reviews on claims with knee injections with hyaluronic acid billed with dates of service January 1, 2023, through December 31, 2023.
The SMRC conducted medical record reviews in accordance with applicable waivers, flexibilities, statutory, regulatory, and sub-regulatory guidance.
Common Reasons for Denial
- Documentation Did Not Support Medical Necessity
- Refer to Social Security Act (SSA), 1862(a)(1)(A), Internet-Only Manual (IOM), Publication (Pub.) 100-08, Medicare Program Integrity Manual (MPIM), Chapter (Ch.) 3, Section (§) 3.6.2.2. The documentation submitted did not support medical necessity as listed in coverage requirements in the National Coverage Determination or Local Coverage Determination. For example, the documentation submitted was insufficient to demonstrate compliance with the criteria for either initial or subsequent injections, and did not satisfy the medical necessity requirements for ultrasound guidance.
- Documentation Did Not Support Modifiers Billed
- Refer to IOM, Pub. 100-08, MPIM Ch. 3, IOM, Pub. 100-04, Medicare Claims Processing Manual (MCPM) Ch. 1. The documentation submitted did not support the modifiers billed. For example, CPT codes 20610, (arthrocentesis, aspiration and/or injection without ultrasound guidance) and 20611, (arthrocentesis, aspiration and/or injection with ultrasound guidance) the appropriate site modifier (RT or LT) must be appended to designate unilateral services, while modifier 50 must be appended to indicate bilateral procedures. In addition, the EJ modifier is required with the applicable HCPCS code for the administered drug to identify subsequent injections within a treatment series.
- Non-Response to the Additional Documentation Request (ADR)
- Refer to 42 CFR §§405.929 and 405.930, Social Security Act 1815(a), Social Security Act 1833(e) and Social Security Act 1862(a)(1)(A). No documentation was received in response to the ADR letter.
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/
Last Updated Feb 6, 2026