What? Now the LCDs Are Cancelled?

Another chapter in the saga of CMS reimbursement of “skin substitutes” revealed itself on Christmas Eve. CMS announced that the future effective skin substitute LCDs would be cancelled by each MAC. The was less than ten days after announcing that the LCDs would include three categories of skin substitutes, including a 12-month “status quo” category.  While this seemed unlikely to be understood or consistently applied, it opened up, for 12 months at least, the ability for providers to choose from many more products for their patients.   So why did CMS first change the LCDs at the last minute, and then cancel them altogether? And what does it really mean? Is this good news or bad news or some of both? And what should we all do about all this?

The answer to the first question is not clear. Likely explanations could be lawyers or politics. There are potential legal issues with trying to adjust the LCDs this close to the effective date. CMS may have concluded that this was a losing battle and it would be better to just start over with a fresh LCD process, or perhaps even consider a National Coverage Determination (NCD) instead. Or the political work that Venture and many others have done may have finally convinced CMS that the LCDs were not helpful or necessary.

We don’t know the real reason at this point, but one thing is clear:  The Med Advantage plans are still the biggest winners (on second thought maybe this was the real reason?).  Without LCDs in most states now, they will keep their pockets fat with cash as they deny everything based on their draconian commercial plan medical policies. Anyone taking a victory lap over the cancellation of the LCDs may look very naive to these behemoth puppet masters.

So what does all this mean? And is it good or bad? It’s likely some of both. It means that several MACs will not have a skin substitute LCD in effect, and that none of them have explicit coverage determinations about specific products. This is good in that none of the products will be ruled out automatically. It may be bad in that the MACs (and especially the Medicare Advantage plans) have less specific guidance and may continue to limit usage through individual claim denials and audits. And none of this fixes the unacceptably low $127 per square cm rate or the insufficient physician application fee for private office and mobile practitioners in the PFS.  It’s this rate that needs even more focus, as increasing it to parity with the physician fee in the HOPD is the only way to allow physicians to choose products based on their clinical value rather than the cheapest price.  If assured ample reimbursement for the procedure that includes getting to the patient, supplies, all the costly software and consulting-based solutions to ensure proper claim generation, then there will be less impetus to use the cheapest graft.  

So what should we do in response to all this? Our recommendation for now is ignore the noise. Clinicians should continue to make good clinical decisions using established products and solid documentation. Prepare your wounds properly before skin sub applications, and consider trying advanced therapies like Ultra Mist or PRP in addition.  Likewise industry participants need to continue to develop evidence to support their products in different wound types. Do not assume the war is over.

And we all need to support a permanent legislative solution that will put these issues to rest forever and stabilize the wound care industry, a solution like the bill introduced on December 18th by Representative Gabe Evans, (R-CO).  If that bill were to gather momentum, a real Christmas present could be given to all of us.  While legislation takes time and is only part of the solution alongside oversight of rogue bureaucrat regulators and an NCD, we suspect much more will come from this and the Cassidy Bill in the Senate in the very near future.   Our aim should be to make reimbursement consistent and fair while also offering huge savings to Medicare and prioritizing patient access to proven effective therapies.  We can accomplish all this, especially if we let the real noise leave the party, that obnoxious group of fraudsters and profiteers always looking for their next loophole to exploit.  Move along please, there’s nothing left to see here…  

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