Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Left knee osteoarthritis 

Treatment: Hyaluronan injection medications 

The insurer is denied coverage for the Hyaluronan injection medications.

The denial is upheld. 

This was then a male patient with a diagnosis of left knee osteoarthritis. The patient received treatment from an orthopedic surgeon consisting of Gel One injections to his left knee. The patient reported relief for several months.  The patient then received another injection with benefit.  The patient requested for coverage for the treatment. 

A review of the Clinical Practice Guideline (CPG) by American Association of Orthopedic Surgeons (AAOS) cites, that the 2013 osteoarthritis (OA) knee treatment CPG contains one significant recommendation change from the 2008 CPG, and this is with regard to the issue of visco-supplementation.  The 2008 OA knee CPG 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 CPG. The second edition CPG recommendation states that the AAOS cannot recommend using hyaluronic acid (HA) for patients with symptomatic OA of the knee, with a "strong" rating, based on supporting evidence from 3 high-quality and 11 moderate-quality research studies that met the inclusion criteria. The AAOS work group understands the potential impact that this recommendation could have on clinical practice.  Nonetheless, the CPG's best evidence synthesis does not support the efficacy of visco-supplementation.  Although statistically significant outcomes were seen in some studies with higher molecular weight HA preparations, these outcomes were not clinically significant, based on a lack of minimum clinically important improvement (MCII).  (For more information on MCII, see "The Importance of Clinical Significance in AAOS CPGs," AAOS Now, May 2013.)

An Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review reported that published knee osteoarthritis (OA) clinical trials comparing injection of viscosupplements vs. placebo have yielded inconsistent results.  Higher quality larger trials have generally found less clinical improvement in pain and function than smaller poor quality studies.  It was concluded that any clinical improvement attributable to hyaluronic acid (HA) is small at best and probably not clinically meaningful.  Evidence also appeared to be insufficient to demonstrate clinical superiority for the higher molecular weight products. (AHRQ, 2011) Another meta-analysis of 89 randomized controlled trials [RCT] including 12,667 patients concluded that HA had minimal effects on pain and function with knee OA, but it did increase risk for adverse reactions.  They also suggested publication biases in favor of HA treatment. (Rutjes, 2012)

Fourteen HA studies were analyzed, and although it was noted that a few individual trials found statistically significant treatment effects, when combined in a meta-analysis, the evidence did not meet their "minimum clinically important improvement" (MCII) thresholds.  It was conceded that there might be some subgroup of responders who could be helped by HA, but that subgroup has not yet been identified (AAOS, 2013). 

As to date, the treatment with hyaluronic acid (HA) injection is not supported by clinical practice guidelines. Thus, HA injection is not considered medically necessary to treat this patient's medical condition.

The health care plan acted reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for the Hyaluronan injection medications to treat the patient's left knee arthritis should be upheld.  The medical necessity is not substantiated.