Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Knee Pain
Treatment: Euflexxa-Hyaluronan injections (J7323)
The insurer denied the Euflexxa-Hyaluronan injections (J7323).
The denial is upheld. 

This patient is a male with right knee pain. He had undergone two arthroscopic surgeries and had continued problems. Eulfexxa injections were provided. His physical examination was significant for no limp, effusion, tenderness and motion 0-125.  The patient's body mass index (BMI) was 46.  His physician diagnosed osteoarthritis and recommended Euflexxa injections.

No, the proposed Euflexxa-Hyaluronan injections (J7323) are not medically necessary.

The scientific literature had previously recommended viscosupplementation for the treatment of osteoarthritis if all other courses failed prior to surgery.   However, the recommendations for use of viscosupplementation have changed.

A review of the Clinical Practice Guideline by the American Academy of Orthopedic Surgeons (AAOS) cites the following (9):

The osteoarthritis (OA) knee treatment Clinical Practice Guideline (CPG) contains one significant recommendation change from the Clinical Practice Guideline, and this is with regard to the issue of viscosupplementation. The osteoarthritis (OA) knee Clinical Practice Guideline included an "inconclusive" recommendation regarding the use of intra-articular hyaluronic acid (HA) injections that was largely the motivating factor for the expedited update of the Clinical Practice Guideline.

The second edition Clinical Practice Guideline recommendation reads "We cannot recommend using hyaluronic acid (HA) for patients with symptomatic OA (osteoarthritis) of the knee," with a "Strong" rating, based on supporting evidence from three high-quality and 11 moderate-quality research studies that met the inclusion criteria.

The work group understands the potential impact that this recommendation could have on clinical practice. Nonetheless, the Clinical Practice Guideline's best evidence synthesis does not support the efficacy of viscosupplementation. Although statistically significant outcomes were seen in some studies with higher molecular weight hyaluronic acid (HA) preparations, these outcomes were not clinically significant, based on a lack of minimum clinically important improvement (MCII).

The Orthopedic group reports "strongly do not recommend use." Additional references and expert opinion do not support benefit (see 'References' section).

A meta-analysis was completed of multiple references. These are high-level evidence-based criteria which does not support use.

According to Jevsevar, et al (1):

Abstract
BACKGROUND:
The purpose of this analysis was to determine the clinical significance of injectable hyaluronic acid (HA) in the treatment of knee osteoarthritis, and to assess which trial-level factors influence the overall treatment effect of HA (hyaluronic acid) on pain (as measured by a VAS [visual analog scale] or the WOMAC [Western Ontario and McMaster Universities Osteoarthritis Index]) and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness subscales.

METHODS:
A comprehensive literature search of PubMed, EMBASE, the Physiotherapy Evidence Database, and the Cochrane Central Register of Controlled Trials was done to locate randomized controlled trials that compared HA (hyaluronic acid) with control treatment and had a minimum of thirty patients per subgroup. To be considered for inclusion, each article had to include VAS (visual analog scale) or WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain, WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)  function, and/or WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness as outcomes because the minimal important difference (MID) has been established for these instruments. A "best-evidence" systematic review and meta-analysis of nineteen trials was performed; because of high heterogeneity among the trials, meta-regression analyses were conducted to determine the influence of trial characteristics on overall HA (hyaluronic acid) treatment effects for pain, function, and stiffness.

RESULTS:
The most consistent finding was that double-blinded, sham-controlled trials had much smaller treatment effects than trials that were not sufficiently blinded. For double-blinded trials, the overall treatment effect was less than half of the MID (minimal important differences) for pain, function, and stiffness. Other significant associations were found for cross-linked HAs (hyaluronic acid) and follow-up duration. However, the effect sizes among double-blinded trials of cross-linked HAs (hyaluronic acid) were still less than half of the MIDs (minimal important differences) for pain and stiffness. The statistically significant effect of follow-up duration disappeared when the open-label trials were removed from the analysis.

CONCLUSIONS:
Meta-analysis of only the double-blinded, sham-controlled trials with at least sixty patients did not show clinically important differences of HA (hyaluronic acid) treatment over placebo. When all literature was added to the analysis, the overall effect was greater but was biased toward stronger treatment effects because of the influence of nonblinded or improperly blinded trials.

The denial would thus be appropriate and consistent with current practice.