early adoptors (at amputees’ expense)


early adopters (at amputees' expense)

The importance of the proposed changes to lower limb prosthetic clinical care, coverage, and coding by Medicare’s contractors has dominated the last few posts I’ve written and will do so again today. We need to turn to the more insidious – though, sadly, entirely expected – implications of the draft Local Coverage Determination.

Yesterday, I received a link to United Healthcare’s medical policy update bulletin (the no-initial-caps styling of the document belying its significance), 36 pages of scintillating minutiae about pending changes to the company’s medical policies. Medical policies, the name notwithstanding, set forth an insurance company’s coverage position for a variety of different treatments. Every major private insurer has a medical policy (or clinical policy, as some prefer to call them) describing what it covers and does not cover when it comes to lower-limb prosthetic devices. 

Page 27 of the United Healthcare bulletin is where we run into trouble:

Added coverage guidelines for vacuum pumps for residual limb volume management and moisture evacuation systems among amputees (HCPCS codes L5781 and L5782) to indicate:

The use of vacuum pumps for residual limb volume management and moisture evacuation systems among amputees is unproven and not medically necessary due to insufficient clinical evidence of safety and/or efficacy in published peer reviewed medical literature[.] (emphasis added)

United Healthcare states that this change will go into effect in just over 3 weeks, on October 1st. 

If elevated vacuum had just come to market without research proving its efficacy, if United Healthcare had reached this decision based on its own thorough review of the applicable literature, and if these components were not medically necessary, this “evidence-based” conclusion might not be so offensive. Unfortunately, none of those things are true. The only reason that United Healthcare has made this change to its coverage guidelines is because Medicare’s contractors have provided it the cover to do so without fear of reprisal.

Why do I say that? Because before the Medicare contractors’ publication of the draft Local Coverage Determination, United Healthcare covered elevated vacuum. However, once the draft proposal found its way into the public eye – including its unsupported conclusions about elevated vacuum – UHC adjusted its coverage policy to make it consistent with the draft document. 

Let’s review the timeline here: July 16 – Medicare contractors publish draft proposal; September 8 – United Healthcare publishes updated coverage guidelines; October 1 – new UHC guidelines go into effect. Total time from Medicare’s proposed changes to private payer implementation? Seventy-five days. I would hazard a guess that there are some private insurance claims for lower limb prostheses that have been stuck in prior authorization longer than that.

I’d like to tell you that this is an unanticipated, unforeseen consequence of Medicare’s draft proposal. Unfortunately, it is not.

In my August 31st post, I included a link to the formal comments I submitted to Medicare’s contractors regarding the proposed changes. In that document, I said the following:

[G]iven the fact that every proposed change related to coding in the Draft LCD has the effect of decreasing overall reimbursement for lower limb prostheses, private payers have a huge financial incentive to follow Medicare’s lead in this instance. There is no economic argument – literally none – in favor of not adopting the provisions of the LCD if you operate a private insurance company.

Thus, to act as if changes to the current LCD will somehow remain cordoned off from the broader private insurance market would be naïve, in direct conflict with historical precedent, and economically inconsistent with private payers’ short-term interests. The draft LCD does not potentially affect just amputees covered by the Medicare program; it will directly affect virtually all amputees in the United States. For people like me who depend on a prosthesis every second of every day to navigate the world, the stakes here could not be higher.

I also discussed this exact issue – elevated vacuum – in my comments:

[T]he DME MACs take the position that there is “insufficient published clinical evidence” in support of elevated vacuum suction systems, rendering them medically unnecessary.[ ] First, that is simply untrue. Plenty of peer-reviewed, published research exists supporting the efficacy of elevated vacuum. Second, the DME MACs have chosen to reach this new conclusion more than a decade after Medicare’s HCPCS Coding Workgroup created the codes describing elevated vacuum. Tens of thousands of Medicare amputees have received these devices since these codes went into effect. They have used them to control the volume of their residual limbs, to remove excess moisture, and to assist in wound healing. 

The most bizarre element of this decision is that more evidence supporting the use of elevated vacuum exists today than existed in 2003. To deny amputees the right (1) to continue to use what they have consistently and successfully used for more than a decade, and (2) to access this type of technology at all moving forward, even when clinically appropriate, defies easy explanation. This is especially true in light of the fact that the DME MACs have failed to cite any clinical evidence in support of their conclusion.

With every passing day, the draft LCD’s continued existence puts amputees insured by private insurance companies in the crosshairs, increasing the likelihood that the devices they have worn and depended on for years will suddenly be stripped away from them in the future. This is exactly why the draft policy should be rescinded immediately, not just placed “on hold” while Medicare’s contractors try to amend it.

While I’m not prone to hyperbole, I can’t overstate the significance of what’s transpiring here. Since 2003, Medicare’s contractors have approved tens of thousands of elevated vacuum devices for lower-extremity amputees because they deemed these components medically necessary. The contractors have cited to nothing – NOTHING – in their bibliography that supports the “no evidence of efficacy” conclusion regarding elevated vacuum systems. But this draft document, with all of its undisputed deficiencies, has provided United Healthcare the ammunition it needs to now erase from coverage a proven, medically-necessary solution that premium-paying lower limb amputees rely on, every step of every day.

The sad truth is that regardless of what Medicare and its contractors choose to do moving forward, the damage here has already been done. 

5 thoughts on “early adoptors (at amputees’ expense)

  1. I am currently going through such an insurance fight.

    When I went for a new leg under my new insurance, they said that the elevated vacuum system that I am wearing is experimental and investigational.

    I am currently on my second level of appeals hoping that my old pump will hold out.

    Can I afford the vacuum pump, sure it isn’t that expensive. But why would I be paying $300 a month for insurance that doesn’t cover squat?

    • Equally problematic, what if someone else who uses the vacuum pump today can’t afford a replacement one if the insurance company denies it? I know you say it isn’t that expensive, but Medicare’s fee for the component is between $3,700 and $3,900 depending on the state you live in. I wouldn’t term that inexpensive for most people.

      But here’s the bottom line: good science supports the use of these systems. There are numerous published studies, all of which tend to conclude that amputees who use these devices enjoy real benefits – volume control, wound healing, improved fit etc. To characterize them as experimental more than 12 years after Medicare first began approving claims for them defies logic.

    • The number I got was a bit lower, and within the range I can afford.

      But yeah, when I switched to the vacuum system the overall fit of my sockets through out the day improved tremendously, and I no longer have nearly as bad sweating issues as I had with the pin system I used previously.

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