If You Use “Skin Substitutes,” Read This and Pass It On

The Alliance of Wound Care Stakeholders has alerted its member organizations to a “policy article” just released by the Medicare Administrative Carrier (MAC) Noridian limiting coverage of Cellular and/or Tissue Based Products (CTPs) to the treatment of Venous Leg Ulcers (VLUs) and Diabetic Foot Ulcers (DFUs) only.

Apparently Noridian has noted claims for amniotic membrane derived CTPs for indications other than the treatment of VLUs and DFUs. The original coverage of these products had limited their use to VLUs and DFUs because the only published literature available addressed the efficacy of CTPs in refractory VLUs and DFUs. Noridian argues that, as they have not received any evidence-based, peer-reviewed clinical literature “published in the core medical journals” to support use in other indications, Noridian considers clinical use outside of the care of DFUs and VLUs “not reasonable and necessary” and therefore “non-covered.” The Noridian article states it will, “gladly review any evidence-based, peer-reviewed clinical literature published in the core medical journals which may indicate that coverage may be reasonable for other wound types. Such articles should include the results of robust CMS and/or FDA approved clinical trials and/or meta-analysis that support any additional indications.”

Clinicians should be aware that this policy article by Noridian may result in many CTP claims being denied.  The Alliance and its member organizations are crafting a response, which will likely focus on the issue of whether a MAC can change coverage policy based on a policy article, as opposed to the usual mechanism of issuing a Local Coverage Determination (LCDs). However, it must be said that many MACs already have LCDs which define a very narrow clinical use case for CTPs. I have brought attention to this issue in many prior blogs, including my concern that if audits were to occur, the financial result for physicians and hospitals will be devastating. Last week at the SAWC, a vascular surgeon told me that her facility was undergoing such an audit of CTP use, and the payback would likely be big. Unfortunately, we all knew this would happen.

On June 6, 2017, I published an article in Today’s Wound Clinic about what it would take to “Keep Skin in the Game” for wound care patients who really need Cellular and/or Tissue Based Products (CTPs).

I ended it with a “plea to our industry:”

A Plea to Our Industry

We need to conduct more generalizable trials if we are going to understand the effectiveness of CTPs among very compromised (but typical) wound clinic patients, so that we can determine the “spend” in relation to the achieved real-world outcome. If we as an industry do not do this, there is a future scenario in which physicians with a high utilization rate of CTPs experience a claw back of their Medicare Part B revenue because their resource use will be too high in relation to their quality scores (since there are no outcome measures for them to report that are relevant to cellular products). In truth, we may not need to worry about that scenario, which is still some years away [under MIPS], because we may find it difficult to provide CTPs long before that. If the CTP manufacturers do not initiate real-world clinical trials, or at least analyze currently available real-world data to expand their indications for use, we will not be able to provide CTPs to the patients who really need them. [italics added CEF]

For more than a decade, the USWR did what was needed to get the registry ready so that the FDA would accept data from it for a Real World Effectiveness study. We developed a method to risk stratify wounds and ulcers called the Wound Healing Index (WHI). We developed quality measures so we could control for variations in the standard of care. We developed a novel method to ensure that there was consistency in how clinicians determined the ICD-9 and ICD-10 diagnosis code of the wound or ulcer, using a series of clinical decisions made inside the electronic health record (EHR) so the physician selects the right code in a standard way. We ensured that we collected all co-morbid conditions and medications. We structured the CTP application information, so we knew exactly what product was applied, whether it was applied to more than one wound, what dressing was put over it, and the exact details of the wound at the time of the application (e.g. whether tendon was exposed, slough or necrotic material or infection was present). We made sure wound outcomes were reported “honestly,” and that the data were transmitted directly from the EHR in a way that could not be vetted by anyone for the purpose of marketing or other reasons. Then we published a paper on the standards that needed to be followed to use registry data from EHRs for clinical research. We even did what was needed to ensure we could link all the Medicare patients in the USWR to the Medicare data warehouse to get all the cost information.

I thought that some of the CTP manufacturers would analyze real world data to expand their indications for use with the FDA and then take that data to the payers. I thought they would support the ongoing work of the registry so it would be there when the crisis came. But, research like that is expensive. Using data that is not vetted as well, not monitored as well, doesn’t include information about variations in care and doesn’t report the wounds that don’t heal is a lot cheaper. And reporting honest healing rates is scary. Real world healing rates don’t look like the healing rates in prospective, randomized controlled trials. Real patients are sick and their wounds are really serious. It’s easy to understand why this difficult and expensive research didn’t get done.

So, the day of reckoning I’ve been worried about for the skin substitute industry has arrived.   The use of all skin substitutes is at risk outside of VLUs and DFUs. The Noridian LCD will also affect the lucrative intra-operative (in-patient) market. Surprisingly, some hospitals have been submitting invoices for CTPs used in the operating room. That can’t go on. And now the surgeon is specifically at risk for his or her application fee, even if the procedure is performed in the operating room.

We happened to have US Wound Registry (USWR) data handy through 2016, obtained from direct-from-EHR transmission to the USWR, so we looked at the use of CTPs in hospital based outpatient centers.

We found that:

  • Venous leg ulcers comprised 18.7% of the wounds and ulcers in the HOPD and received 31.6 % of the CTPs
  • Diabetic foot ulcers comprised 13.4% of the wounds and ulcers and received 29.7% of the CTPs
  • “Generic” Chronic ulcers (which are non-healing due to the patient’s underlying diseases) comprise 18.9% of all the wounds and ulcers seen in the HOPD and receive 17.2% of all the CTPs
  • Traumatic wounds comprise 17.1% of all wounds and ulcers and receive 5.6% of CTPs
  • Dehisced surgical wounds comprise 8% of all wounds in the HOPD and receive 3.9% of CTPs
  • Pressure ulcers comprise 12.9% of all wounds and ulcers and receive 6.9% of CTPs

Based on the above, I suppose the good news is that VLUs and DFUs, even though they comprise only 32.1% of the wounds and ulcers in the HOPD, receive 61.3% of the CTPs. That’s good news because only 40% of the CTP applications may need to stop. The bad news is that “the Wounds with no name” comprise 36% of all the wounds and ulcers seen in the HOPD (chronic ulcers and traumatic wounds). Together they get 22.8% of all the CTPs applied in HOPDs. The rest of the CTPs are applied to all the other problems we care for (e.g. pressure ulcers, dehisced surgical wounds, etc.) Those patients may be out of luck. No one does research on them or “the wounds with no name.” Noridian knows that the published data in the “core medical literature” they asked for won’t be forthcoming.

Based on the above data, the bad news is that approximately 40% of the CTP applications in the HOPD could be outside of the coverage policy of the payer. Hospitals and practitioners are going to need some very careful scrutiny of those coverage policies. Even CTP applications in VLUs and DFUs are going to need careful review. They will have to meet the fine print of the policies, some of which are very restrictive. Audits are happening. Read your MAC’s LCD on skin substitutes. This will be messy.