Effective April 1, 2015, Florida Blue HMO (Blue Cross Blue Shield) is no longer paying for intra-articular injections of hyaluronan (HA) drugs—specifically Hyalgan or Supartz, Euflexxa, Orthovisc, Synvisc or Synvisc-One or Gel-One.
On May 1, 2015 Oregon’s LifeWise Health Plan will also stop paying for intra-articular injections of hyaluronan.
Blue Cross Blue Shield of Massachusetts, which was probably the first payer to reverse its policies with regards to HA injections, stopped paying for Orthovisc, Synvisc and Synvisc-One on July 1, 2014.
What Is Going On?
These changes in coverage, which for many orthopedic practices are coming as a shock, were triggered by a May 2013 change in clinical practice guidelines from the American Academy of Orthopaedic Surgeons (AAOS).
Hyaluronic acid injections have been an important part of many practices for years and physicians who use HA have reported generally positive outcomes for their patients.
In a recent American Association of Orthopaedic Executive’s newsletter, Midwest Orthopaedics Executive Director Barbara Stack was quoted as saying that her clinic was hit hard after Blue Cross Blue Shield of Kansas City said it would not pay for HA injections because they no longer consider such injections to be medically necessary. According to Director Stack the new policy came with almost no lead time before it took effect. Not only do HA injections represent a significant amount of income for Midwest’s practice, but, said Stack, “We have patients who are stunned and extremely distressed.”
Vinod Dasa, M.D., associate professor of Clinical Orthopaedics at LSU told OTW; “As far as hyaluronic acid injections, I think most physicians will tell you their experience is quite different from what the AAOS guidelines recommend. In my opinion, these injections do work and work very well in the appropriate patient population i.e. isolated mild/moderate knee OA.”
AAOS Guidelines
AAOS revised its long-standing clinical practice guidelines for HA injections of the knee in May 2013. The change came after an extensive review of the literature and concluded that AAOS “cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee.”
While a vast majority of payers are still paying for HA, a number of them have started to make doctors and their office staff jump through new pre-authorization hoops.
HealthPartners in Minnesota, for example is requiring new pre-authorizations for Orthovisc, Gel-One, Hyalgan and Supartz.
More than a few offices and clinics and starting to move to a patient self-pay model. .
The Hyaluronic Acid/Viscosupplement Coalition
In response to AAOS and the payer coverage changes, a group of HA suppliers formed an alliance to, in the words of their spokesperson Ken Long, “address misconceptions about the class and to invest in research to create a better understanding of HA/viscosupplement products.”
The alliance, known as HAVC (Hyaluronic Acid/Viscosupplement Coalition), includes Bioventus LLC, DePuy Synthes Mitek Sports Medicine, Ferring Pharmaceuticals Inc., and Zimmer Holdings, Inc. It operates under the auspices of AdvaMed, the medical device industry’s largest trade association.
As part of their effort to frame the AAOS change in clinical practice guidelines, HAVC provided the following clarifications of the AAOS announcement.
- AAOS did NOT recommend against HA. It said that it cannot recommend HA treatment which is quite different from recommending against it.
- The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, and ACR both recommend the use of HA.
HAVC also alerted OTW to a letter published in the August issue of the Journal of the American Medical Association (JAMA).
JAMA Letter
Last August in the “Research Letters” section of JAMA, Drs. Schmajuk, Bozic and Yazdany published a letter titled Using Medicare Data to Understand Low-Value Health Care: The Case of Intra-articular Hyaluronic Acid Injections.
That letter was a review of 2012 Medicare Utilization and Payment data which found that in 2012, Medicare Part B reimbursed for 1.2 million injections of HA for 423, 669 Medicare patients by 12, 761 physicians or other clinicians.
That’s a lot of HA. Tanker car loads.
The most frequent administration was a three injection, three week protocol. The average reimbursed amount was $179 for the HA and $69 for the injection.
In their letter, Drs. Schmajuk, Bozic and Yazdany characterized HA as a “low value” treatment for severe knee osteoarthritis. They said HA injections were “costly and have limited clinical benefit.” And they concluded that: “Based on recent guidelines and studies, intra-articular hyaluronic acid injections represent low-value care and an inefficient use of healthcare resources. Medicare beneficiaries and society would be better served if physicians and others involved in paying for and delivering healthcare worked together to minimize the use of such low-value care.”
Not everyone agreed.
Counter Argument
Phillip Band, Ph.D., who is currently at the NYU Hospital for Joint Diseases, wrote a rebuttal to the JAMA letter. From 1983 to 2000, Band was an employee of Biomatrix and helped develop hyaluronic acid for ophthalmic surgery, soft tissue augmentation, drug delivery and intra-articular injection.
Band wrote that the JAMA authors failed to distinguish between efficacy studies and effectiveness studies in their evaluation of HA as a “low value” treatment. Said Band: “Effectiveness refers to performance under real-world conditions, rather than the idealized conditions of a placebo-controlled trial.” And, said Band, the AAOS guidelines were based on a meta-analysis that excluded effectiveness trials.
Band went on to write: “Because the article by Schmajuk et al. questions the value of intra-articular hyaluronic acid injections, the authors should not neglect high quality effectiveness trials.”
And did Band know of any such trials?
Indeed he did and said; “In particular, a randomized, pragmatic, health economic trial reported that intra-articular hyaluronic acid injections provided statistically significant and clinically important incremental improvement over appropriate care, with a cost utility ratio of $10, 000 per quality-adjusted life year (QALY).” The study was by Raynauld JP, Torrance GW, Band PA, et Al.; Canadian Knee OA Study Group. A Prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F20 into the treatment paradigm for patients with knee osteoarthritis (part 1 of 2).
Rebutting the Rebuttal
Schmajuk et al. answered Dr. Band’s rebuttal saying: “The meta-analysis performed by the AAOS of hyaluronic acid studies showed that among high quality studies, there was no clinically significant differences that were statistically significant difference between hyaluronic acid and sham injection groups. Although some individual studies reported differences that were statistically significant, others reported conflicting results or found no differences, and the aggregate differences were not statistically significant.”
It is perhaps noteworthy that one of the authors of the original letter in JAMA was Kevin Bozic, M.D. who is Chair of the AAOS Council on Research and Quality.
Medicare
Medicare is, of course, the lead dog pulling the payer sled. The authors of the JAMA letter were clearly addressing CMS [Centers for Medicare and Medicaid Services] when they wrote: “Medicare beneficiaries and society would be better served if physicians and others involved in paying for and delivering healthcare worked together to minimize the use of such low-value care.”
What is Medicare’s thinking?
One clue may well have come in late December 2014 when CMS’s partner agency, the Agency for Healthcare Research and Quality (AHRQ) Technology Assessment (TA) program, issued an assessment report of HA.
According to the preamble to that report, such analysis helps CMS to determine national coverage policies.
AHRQ reported on 141 peer reviewed studies regarding HA and concluded:
- There is not enough evidence that HA can or cannot reduce the rate of knee replacement surgery
- The strength of evidence that HA improved knee function was low
- The evidence showed that HA relieved knee pain but that it was of minimal clinical importance
- The evidence that HA improves a patient’s quality of life was insufficient
What’s Next?
The central dilemma is being played out at clinics all over the country. Many practitioners have learned how to use HA effectively—using patient selection and proper management of expectations—to relieve pain and improve function.
If payers continue to pull away from reimbursing HA, cash pay models will no doubt increase in popularity. Physician activism and pushback, we expect, will also increase since HA is typically the last remaining step before the big, $30, 000-$40, 000 knee replacement surgery.
Clinicians who believe in HA claim they actually can tell which patients will benefit once they receive HA treatment. And when the total cost per treatment (including physician fees) is under $1, 000 per patient—HA would certainly seem to have a place in the orthopedic armamentarium.
The emerging question is where?
