The Future of Viscosupplementation for OA of the knee with the “Blues”

BLUES NEW POSITION STATEMENT: “Intra-articular hyaluronan injections are associated with clinically irrelevant benefit and an increased risk of adverse events; therefore, are considered not medically necessary.”

 Effective April 1, 2015 several of the “Blues” such as Florida Blue[1] and BCBSWNY[2] (Healthnow)  took the lead for the “Blues” in taking unprecedented actions against paying for Intra-articular hyaluronan injections of the knee as a treatment for pain caused by osteoarthritis of the knee.   

In a “quick check” of other Blues, Premera[3] and BCBS Kansas[4] we found revisions to their policies deleting the “requirements for coverage” and replacing it with non-coverage as of June 1, 2015.

While these actions are for Blue Cross “plans”, Florida and Alabama[1] have instituted “pre-authorization” requirements for their Medicare members.  

Florida Blue Now states:

Florida Blue: http://mcgs.bcbsfl.com/     09-J1000-22  04/01/15

POSITION STATEMENT:

Intra-articular hyaluronan injections are associated with clinically irrelevant benefit and an increased risk of adverse events; therefore, are considered not medically necessary.

 Medicare members ONLY:

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request for Viscosupplementation, Hyaluronan Injections to expedite the medical review process.

1. Click the link Viscosupplementation, Hyaluronan Injections (e.g. Synvisc®) – Certificate of Medical Necessity(MS Word) to open the form.
2. Complete all fields on the form thoroughly.
3. Print and submit a copy of the form with your request.

We note that the FCSO contractor’s LCD L29307 remains the same. http://medicare.fcso.com/Fee_lookup/LCDDisplay.asp?id=L29307+&submitcode=+Submit+

While other citations are also offered, the carrier’s new positions appear to be based primarily on the American Academy of Orthopaedic Surgeons’ (AAOS) guideline on treatment of OA of the knee that states they cannot recommend using HA for patients with symptomatic knee OA and a 2014 BCBS Association Technology Center meta-analyses on the treatment of knee OA with IAHA.

The American Academy of Orthopaedic Surgeons’ (AAOS) guideline on treatment of OA of the knee states that they cannot recommend using HA for patients with symptomatic knee OA.

This is a strong recommendation, meaning that the quality of the supporting evidence is high. This recommendation was based on a meta-analysis of 3 high-strength and 11 moderate-strength studies that showed that the overall effect was less than 0.5 minimally important different units, indicating a low likelihood that an appreciable number of patients achieved clinically important benefits.

AAOS states that practitioners should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.  This replaced the 2008 guideline in which they offered NO recommendation due to the lack of evidence.

In 2014, BCBS Association TEC published a systematic review of recent meta-analyses on the treatment of knee OA with IAHA.  Included in the assessment were 5 meta-analyses published in 2011 or later. (6,7,9-11) Two meta-analyses concluded that IAHA provides a clinically meaningful benefit; 3 concluded that the evidence did not demonstrate a clinically meaningful benefit. It was not possible from the data to determine the proportions of patients achieving clinically meaningful improvement, although the AAOS analysis determined that is was unlikely that an appreciable number of patients would benefit compared with placebo. It is also possible that these results were biased in favor of IAHA, due to unpublished trial data. When results from unpublished trials were obtained, the magnitude of effect was notably lower compared with published results. Substantial heterogeneity between trials was also evident, increasing uncertainty. The Assessment concluded that the 5 meta-analyses, sampling from a similar collection of published trials and 2 unpublished ones, highlights biases and difficulty ascertaining clinically meaningful patient-level improvement compared with placebo. Although accumulating evidence would be expected to increase certainty about whether a clinically important treatment benefit exists, the current study results do not provide convincing evidence that net health outcomes are improved with IAHA over placebo.  You can read the entire report at http://www.bcbs.com/blueresources/tec/vols/29/29_6.pdf

We can see the Blue Buzzards getting ready to swoop down on IAHA and while we certainly don’t want to start a mass exodus from viscosupplementation,   we do want you to be vigilant so you won’t be caught unaware when and if your carrier changes their coverage decision or restricts it by requiring pre-authorization of the “supplement product”.

For the Blues, we think there is now enough credible evidence to warrant updating your particular carrier’s policies, insuring you verify coverage before starting the series and also issuing an advanced notice to your prospective OA patients where they accept personal liability of the payment if the injection is denied.

If you are to survive changes, you must be able to defend your treatment with proper documentation.  The Academy has a recorded webinar available on OA with a detailed supplement manual for you.  http://events.constantcontact.com/register/event?llr=quyh77cab&oeidk=a07eat0s0us88e312a0

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Copy links and past into your browser for proper viewing. 

1.  Florida Blue: http://mcgs.bcbsfl.com/      09-J1000-22  04/01/15
2.  Health Now https://securews.bcbswny.com/web/content/dam/COMMON/Provider/Protocols/I/prov_prot_20131.pdf   
3.  https://www.premera.com/medicalpolicies/CMI_154350.htm
4.  http://www.bcbsks.com/customerservice/Providers/MedicalPolicies/policies/policies/Intra-articularHyaluronanInjections_Osteoarthritis_2014-03-25.pdf 
5.  www.myprime.com/content/dam/prime/memberportal/forms/AuthorForms/BCBSAL/Commercial/AL_Viscosupplement_PA_ProgSum.pdf