In 2006, a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel evaluated key questions related to the clinical outcomes associated with spinal fusions for patients with degenerative disc disease. The panel examined whether the evidence supported spinal fusions as an effective treatment for patients with DDD. At that time, the panel did not issue a decision memo and the Centers for Medicare and Medicaid Services (CMS) did not draft National Coverage Decision, which left the future of spinal fusions for DDD undefined. Now, we are seeing the same questions asked as payors and providers attempt to navigate a new healthcare environment focused on evidence-based and value-based medicine. In their May 2012 white paper "Critical Review & Impact Analysis of CMS 2006 MEDCAC Panel on Lumbar Fusion for Treatment of DDD," the experts at Musculoskeletal Clinical Regulator Advisers outline the panel's initial conclusions and how coverage and evidence for the procedure has evolved since then.
Here, Vice President of Health, Economic Reimbursement and Public Policy for MCRA Tim Hunter, discusses the key concepts around MEDCAC's decision and where spinal fusions for DDD are headed in the future.
Question: What was the impact of the MEDCAC decision on spinal fusions for DDD?
Tim Hunter: When we go back to the MEDCAC meeting in 2006, an important message was sent; the panel chairman made it clear that CMS was not trying to pursue a Medicare national coverage decision at that time, which gives the indirect inference that they might consider it at some point in the future based upon the availability of published evidence. Here we are six years later and we are going through this process again. The Agency for Healthcare Research and Quality key questions, which were published earlier this year, are very similar to the questions posed in 2006.
When we look at this, our question is, "What has changed in the evidence base from 2006 to 2012 to answer the original questions?"
In 2006, the original AHRQ technology assessment and MEDCAC panel took 1,400 articles on the topic and eventually considered 3 randomized controlled articles. The panel determined that it lacked confidence in the available evidence with respect to the efficacy of lumbar fusion for DDD, with uncertainty surrounding the diagnosis of this condition.
Q: If the evidence was lacking then, what types of studies did they want to see?
Mr. Hunter: The MEDCAC panel laid out what it wanted: a number of very carefully designed, randomized, controlled trials. That is what payors ideally want for new or existing technology where there might be some disagreement about the effectiveness or appropriate patient populations. RCTs comparing spinal fusion to conservative care in patients who have failed conservative care are not practical in this case. The key is to figure out how to give the payor community what it wants without necessarily having to produce RCTs. The industry must figure out a way to give plans what they want in a way that the payors and surgeon community can support and execute.
In the short-term, surgeons and industry need to point to the currently available evidence and explain why non-RCT evidence currently exists to demonstrate patient outcomes. This may take the form of better explaining previously published outcomes, performing meta-analyses to pool results, or determine and disseminate appropriate patient selection criteria.
Q: When facing coverage denials, what can surgeons do to give their patients access to this care?
Mr. Hunter: The best thing spine surgeons can do is help health plan decision-makers understand why a patient benefits from a particular treatment, whether the treatment is conservative care, fusion or another surgical intervention. Show them which types of patients respond best and which don't respond well, and how you predict in advance how patients will respond.
Here, Vice President of Health, Economic Reimbursement and Public Policy for MCRA Tim Hunter, discusses the key concepts around MEDCAC's decision and where spinal fusions for DDD are headed in the future.
Question: What was the impact of the MEDCAC decision on spinal fusions for DDD?
Tim Hunter: When we go back to the MEDCAC meeting in 2006, an important message was sent; the panel chairman made it clear that CMS was not trying to pursue a Medicare national coverage decision at that time, which gives the indirect inference that they might consider it at some point in the future based upon the availability of published evidence. Here we are six years later and we are going through this process again. The Agency for Healthcare Research and Quality key questions, which were published earlier this year, are very similar to the questions posed in 2006.
When we look at this, our question is, "What has changed in the evidence base from 2006 to 2012 to answer the original questions?"
In 2006, the original AHRQ technology assessment and MEDCAC panel took 1,400 articles on the topic and eventually considered 3 randomized controlled articles. The panel determined that it lacked confidence in the available evidence with respect to the efficacy of lumbar fusion for DDD, with uncertainty surrounding the diagnosis of this condition.
Q: If the evidence was lacking then, what types of studies did they want to see?
Mr. Hunter: The MEDCAC panel laid out what it wanted: a number of very carefully designed, randomized, controlled trials. That is what payors ideally want for new or existing technology where there might be some disagreement about the effectiveness or appropriate patient populations. RCTs comparing spinal fusion to conservative care in patients who have failed conservative care are not practical in this case. The key is to figure out how to give the payor community what it wants without necessarily having to produce RCTs. The industry must figure out a way to give plans what they want in a way that the payors and surgeon community can support and execute.
In the short-term, surgeons and industry need to point to the currently available evidence and explain why non-RCT evidence currently exists to demonstrate patient outcomes. This may take the form of better explaining previously published outcomes, performing meta-analyses to pool results, or determine and disseminate appropriate patient selection criteria.
Q: When facing coverage denials, what can surgeons do to give their patients access to this care?
Mr. Hunter: The best thing spine surgeons can do is help health plan decision-makers understand why a patient benefits from a particular treatment, whether the treatment is conservative care, fusion or another surgical intervention. Show them which types of patients respond best and which don't respond well, and how you predict in advance how patients will respond.