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ASMBS welcomes Medicare LSG decision
Following the June 27th decision by the CMS to allow local coverage of laparoscopic sleeve gastrectomy (LSG), bariatricnews.net discussed the decision and its implications, with Dr John Morton, chair of the ASMBS’ Access to Care Committee.
What was your initial reaction the CMS’ decision?
My initial reaction was gratification that the CMS realised that their proposed solution of creating a randomised controlled trial was not the best step forward for patients in need. The solution now is to allow the regional administrators to decide if they are going to cover LSG. The ASMBS is currently in discussions with regional administrators to ensure there will be LSG coverage for Medicare patients.
Given the proposed decision announced in March 2012, were you surprised by the U-turn?
We were hopeful that they would change their mind, but there is never any sort of guarantee. We were just very pleased that they were able to recognise the additional evidence-based data we submitted.
In fairness to the CMS, when they carried out the original review there was a considerable amount of unpublished data that was not available to them. Soon after the CMS’ proposed decision in March, there were four randomised, controlled clinical trial papers published in quick succession. So the facts on the ground changed and I think CMS was quite prudent in recognising the new data and subsequently allowing LSG coverage.
So we are grateful that the CMS has acknowledge the strength of the data and that LSG does play an important role in what is our leading public health problem. We need more tools at our disposal and the LSG is a very powerful addition to our arsenal in dealing with obesity.
The CMS stipulated that Medicare beneficiaries must have a BMI>35, at least one co-morbid condition related to obesity (e.g., diabetes, heart disease), and have previously been unsuccessful with medical treatment for obesity. Do you agree with these requirements?
Yes, the requirements the CMS proposed are consistent with those that have been in place for many, many years stemming from the 1991 National Institutes of Health’s NIH Consensus Statement on Bariatric Surgery. So these requirements do not represent any significant change.
Regarding the patients with a between BMI>30-35, we are accruing more data and I think it is becoming clear that patients, particularly diabetic patients within this weight range would benefit greatly from bariatric surgery. From a cost standpoint, if you look at some of the newer drugs to treat diabetes they are fairly expensive particularly in the long-term. Therefore, I think this will be a discussion that will take place sooner rather than later.
What other aspects of the decision were you pleased to see?
The CMS proposal from March was focused on the elderly, which is a small percentage of the overall Medicare population. The majority of the obese, Medicare population who need assistance are the disabled and the leading cause of disability in my own home state of California is obesity.
The other group to mention are those patients with end-stage renal disease, who are the only group of patients in the US who are guaranteed medical insurance coverage.
This group of patients really could benefit from LSG as they are potential transplant candidates and those of us in the bariatric community see LSG as the ideal procedure for both pre- and post-transplant patients. This is because there are reduced risk around medical absorption, no risk of an in dwelling foreign body on immune suppression, so in many ways it the most suitable procedure.
It is important to remember that no field of medicine treats a single disease with a single medication or procedure, and bariatric and metabolic surgery is the same. We need any many options on the table as possible to try and treat what is a very challenging disease.
How much do you think the CMS was influence by the actions and additional submissions of the ASMBS, SAGES, ASBP etc?
I think it played a significant role. Perhaps more importantly, I think it demonstrated that we work best when we work together and we showed that our interests are not parochial around the surgical field. We are well and truly in the obesity field and looking to get all the possible tools at our disposal.
I think it also showed what it takes to rally the surgical and patient community. The ASMBS, working with the Obesity Action Coalition, was able to get the word out and mobilise patients and surgeons alike.
For example, there were well over 400 submissions received during the comment period and the vast majority spoke in favour of LSG. This was a huge increase from the 150 comments the CMS received in the previous comment period. I think it was really encouraging to see this level of support.
For our readers outside of the USA, could you explain the CMS’ decision to allow local Medicare contractors to decide coverage and whether this will mean a patient’s location will determine if they are eligible?
This is something that is currently being discussed. In general, most of the regional administrators work in closely together, so this allows the CMS to reach an appropriate conclusion and gives them a degree of flexibility on a regional level. We are hoping to reach out to all regional administrators and convince them that LSG coverage is the way forward.
What are the next steps the ASMBS will take in regards to gaining national coverage for LSG?
We will be publishing additional data from the BOLD database, which showed that LSG was positioned between the bypass and the band in terms of safety and efficacy. We will also be reaching out to the regional administrators and to try and ensure that everybody who means the criteria has the opportunity to receive the procedure.
The CMS’ decision is a positive one for patients and the experience has been a positive one for the surgical community as we have been able to put patient safety at the centre of the argument, supported by evidence-based medicine. Ultimately, the decision is a positive one for the country as we are going to be able to treat many individuals who will be able to lead a more productive and fulfilling role in society.