a two-fer

This week started normally. Peggy and I recorded our “standard” weekly podcast, which focused on explaining the alphabet soup of organizations whose work directly and indirectly affects people with limb loss/difference. These include entities that certify the prosthetists who treat us, accredit the facilities in which we receive that care, and devote significant time to prosthetic research and legislative initiatives.

Straightforward, right?

Then, late Monday afternoon, House Republicans released The American Health Care Act, the first step in following through on their promise to “repeal and replace” The Affordable Care Act. We read through the 120+ pages and recorded a new “special alert” podcast Tuesday evening that went live immediately afterwards. In it, we explained what The American Health Care Act would do and how it would directly affect people with limb loss/difference. We also issued a new call-out to our amp’d Activists to again reach out to their legislators to express their thoughts about this new proposal and created updated model letters for amputees and their relatives/friends to personalize and send to their Congressional representatives.

Both podcasts address issues of importance to amputees. If you’re not already subscribed to our iTunes or other podcast feeds, you can visit www.ampdpod.com to listen to them and download our Podcast Summaries. (We’ve now embedded podcast players into the site so you can listen to us without having to leave ampdpod.com.) And whether you’re an amputee yourself or a family member/friend of one, please visit the Current Issues section of our website to directly engage with your elected officials. Your voices matter. A lot. So speak.

how to speak to politicians effectively

Last week in our amp’d podcast, Peggy and I issued a call to action to the amputee community and its family/friends. We asked you to reach out to federal legislators to ensure that two key protections provided by the current health care law – (1) classification of prosthetics as Essential Health Benefits, which prevents insurers from placing annual or lifetime caps on prosthetics, and (2) prohibitions on pre-existing condition exclusions – do not get repealed as part of the heated and quickly-evolving healthcare debate on Capitol Hill. As part of that effort, we created a new “Amputee Activism” section of our website, along with a tool designed to help you develop your skills as an amp’d activist.

In our newest podcast, we now walk through that tool step-by-step, showing you how to professionally and powerfully speak to your Representative and Senators about these two important issues. The debate in Congress is happening right now! If you wait to make your voice heard, it may be too late. So check out the latest amp’d, learn how to become an effective activist for the entire limb loss/difference community, and reach out to your elected officials immediately to ensure that they #DontExcludeAmputees.

 

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. 

draft LCD comments – deadline and mine

deadline and mine 8.31.15

Today, August 31st, is the final day that you can submit comments about the DME MACs’ draft Local Coverage Determination, which would have a significant impact on lower limb prosthetic clinical care, coverage and coding. To say that this is an important issue for amputees in the United States is an understatement: I have worked full-time on nothing other than this since the beginning of July.

If you have not had the chance to comment already, please do so immediately! You need to submit them to the following email address by 5 PM ET:

DMAC_DRAFT_LCD_Comments@anthem.com

Your should address your letter to Stacey V. Brennan, M.D., FAAFP, Medical Director, DME MAC, Jurisdiction B, National Government Services, 8115 Knue Road, Indianapolis, Indiana 46250. (To be 100% accurate, the DME MAC Jurisdiction B website says that comments must be received by “close of business” tomorrow – whether that’s 5 pm ET, 5 PM CT, or 5 PM PT isn’t specified. I suggest ET as the cutoff to ensure that you don’t miss the deadline.)

If you have questions about how to draft an effective comment letter or other LCD-related questions, I’m “on call” through tomorrow. You can either submit questions to me on Twitter using “#askampd” followed by your question or on Facebook on the newly-created Amp’d podcast page (big props to Peggy Chenoweth a/k/a The Amputee Mommy and my partner on the Amp’d podcasts for putting that together). I’ll be watching both through the day and will try to answer questions as quickly as possible.

I have spent a considerable amount of time working on my own comments, which, I’m happy to report, I just completed and submitted a little after midnight. In lieu of a full-blown post either summarizing those comments or cutting and pasting them into what would be by far the longest post I’ve ever drafted on less is more, I’ve opted instead to link to a pdf for your reading pleasure, below.

If you’re in the mood for 12 pages of analysis describing why I think the proposed changes are a bad idea, then you’ll be very happy. If you’re looking for a “normal” less is more post, stay tuned. I’m coming back with lots of new stuff in the coming weeks. In the meantime, thanks to everyone who has worked so hard on this important issue over the last 45 days. It has been a remarkable summer.

McGill Comments to Draft LCD

big changes loom: what you can do!

It’s a big week for lower limb amputees. The Medicare contractors who published the draft rule affecting (1 ) how amputees receive clinical care, (2) which prosthetic components Medicare will cover, and (3) coding of different prosthetic devices are holding a public hearing tomorrow. In addition, comments in response to this proposed rule are due on Monday, August 31st. If you’re reading this saying, “I’m not on Medicare, so this doesn’t affect me,” think again. Medicare’s coverage requirements form the basis of every major private insurance company’s approach to coverage, so if these changes get implemented, your insurance company will likely adopt them within 12 months!

For the lowdown on what the amputee community has accomplished so far, what’s happening over the next 6 days, and what you can do to make your voice heard, listen to our new Amp’d podcast, fresh off the aural press.

missing pieces … in 2 parts

missing pieces 03.12.15

This week I’m going to do something different and split my post in half, as there are two totally separate but important topics I want to cover.

1. New York’s limitation on prosthetic limb benefits

As some readers may know, I’m on the Board of Directors of a few organizations in the orthotics and prosthetics industry. One of those organizations – The National Association for the Advancement of Orthotics and Prosthetics (link on the upper left side of this webpage) – recently took on the task of coordinating a response to a New York State insurance restriction that could have a profoundly negative impact on prosthetic-wearing amputees.

As a result of The Affordable Care Act, every state that opted to voluntarily start an insurance exchange is required to select a “benchmark plan.” As the title suggests, the benchmark plan serves as the baseline for what all insurance plans offered through the exchanges must offer as standard benefits.

The good news is that New York’s benchmark plan covers prosthetics. But the bad news is that it covers only 1 prosthesis per limb per life for adults. One and done. And it gets worse.

I went online to see whether perhaps other New York exchange plans nevertheless offer prosthetic coverage that acknowledges the reality that amputees require a new prosthesis due to changes in their clinical condition over time. After all, the benchmark plan is just a minimum standard; an insurer could choose to offer more than what’s in the benchmark if it wanted to.

I limited my search to “platinum” plans, the ones that offer the most benefits. In my zip code, I had 32 possible separate plans offered by 7 different insurers. Here are the results:

  • United Healthcare: 1 prosthetic device per limb per life;
  • Empire BCBS: 1 prosthetic device per limb per life;
  • Emblem Health: 1 prosthetic device per limb per life;
  • Oscar: 1 prosthetic device per limb per life;
  • Fidelis Care: 1 prosthetic device per limb per life;
  • Affinity Health Plans: 1 prosthetic device per limb per life; and
  • Health Republic Insurance: 1 prosthetic device per limb per life.

And it gets worse.

The benchmark plan is issued by a subsidiary of United Healthcare: Oxford. When I co-owned an O&P facility in NY from 2001 -2006, Oxford was the only insurer with a 1 prosthesis per limb per life limitation. And I know from speaking to New York prosthetists between 2007-2014 that it remained the only payer with such a restriction, even after I left the world of patient care. But as soon as New York selected the Oxford plan as the benchmark, all of the other insurers offering plans on the exchange adopted the restriction, effectively universalizing a limitation that had been limited to only 1 payer for at least 15 years.

As an amputee living in New York with more than a passing knowledge of the Affordable Care Act’s requirements, this limitation struck me as potentially violative of multiple provisions in the law. NAAOP agreed and has allocated key resources to coordinate an effort to get this changed. Working with local stakeholders who have donated significant time and resources of their own, numerous lawmakers in Albany are now learning about the 1 prosthesis per limb per lifetime restriction. In addition, there is an online petition that allows people to communicate their outrage at this limitation. In just one week we have secured nearly 2400 signatures, but we need more.

Please make sure that as many amputees as possible go to onelimbforlife.com to sign this electronic petition. We need New York legislators to pay attention to the potentially life-changing damage that this restriction to medically necessary prosthetic care could cause individuals with limb loss living in New York. Thanks in advance to everyone who shares this link!

2. never take anything for granted

I was speaking with a friend on Tuesday morning about the 1 prosthesis per limb per life restriction. As I was getting ready to jump off the phone he said, “I’ve got some bad news for you.” I figured I was about to learn that we had missed something important in the course of developing messaging for New York lawmakers regarding this insurance issue, so I could only sit there for a moment feeling the world rotate oddly around me as he said that Phil Kreuter had died.

A physical therapist, Phil devoted a huge part of his professional life to working with people with disabilities, especially amputees. He was the person who, more than anyone else, helped me see life with a prosthesis as a life full of opportunities. It helped that Phil had a track record that made his words carry extra resonance: he had worked at numerous national and international athletic competitions, including the ’96 Paralympics. He wasn’t just spewing empty words; he had seen it and, equally important, worked with people who had done it.

When I received my first prosthesis, Phil was the guy who trained me, day after day, for months. He taught me what “hop-skip” was. He let me use the treadmill in his facility for 60-90 minutes straight, multiple days per week, long after my insurance plan’s physical therapy benefit had run out, letting me train for free while paying able-bodied patients were there. He accompanied me on my first 10K race a few months after I got my prosthesis, spending 90 minutes on the pavement at a laughably slow pace while giving me water and words of encouragement that carried me through the final miles. He donated time on the weekends to take me to the local track and taught me how to run leg-over-leg in my everyday prosthesis, before I even knew what a running foot was.

As our friendship grew, he loaned me back issues of Tricycle, a Buddhist magazine, as I started trying to gain some spiritual perspective on why I had survived my accident. We spent weekends and evenings talking about starting a not-for-profit that would provide able-bodied and disabled athletes the opportunity to compete against each other. Our theory was that we could fundamentally change the perspective able-bodied people had of people with disabilities.  (A fascinating concept that foundered on the financial reality that the cost of the physical space we’d need to do it far exceeded our respective bank accounts. And, interestingly, a concept that groups like The Wounded Warrior Amputee Softball Team ultimately validated.) I came with him when he taught PT students about treating patients with disabilities so they could see a Real. Live. Amputee. I babysat his daughters once.

Unfortunately, we fell out of touch over the last 8 years. It was nothing personal; events just made it that way. But that doesn’t make his sudden absence any less hard to process.

He was, I would guess, only in his mid-50’s and in great shape – an excellent runner and avid cyclist. So learning that he’d suffered a massive stroke and – like that – was gone, left me feeling a deep emptiness, like I’d lost something vital to who I am.

Cara asked what was wrong on Tuesday night after enduring a day of gruff, monosyllabic responses from me. “Phil was probably the person who had the greatest impact on me during the most important time of my life,” I replied. It seems completely contradictory to miss someone you haven’t spoken to in close to a decade. And yet, when it comes to Phil, that makes sense to me.

So Phil, as I type this and feel the lump growing in the back of my throat, I hope you knew how much you meant to me. I hope you understood – even though you’d deny it if I told you – that everything I achieved after my accident was only possible because I had you there to show me. I was so, so lucky to have you as a friend.

And I’ll miss you.

please sir, may I have another?

 

please sir, may i have another 6.3.14On May 28, Medicare published a new rule that would require your prosthetist to submit virtually all prosthetic claims for prior authorization. What is that? Why is Medicare proposing this change in policy? What effect will it have on you? We discuss each of these questions in this week’s (longer-than-normal but important) post.

what is prior authorization?

Prior authorization requires you to seek approval from the payer before you can deliver the item. While common among private payers, which usually require prior authorization in order to confirm what exactly this plan out of the 40 offered by this insurer covers, traditional fee-for-service Medicare – a payment system with the exact same coverage for every beneficiary –  has never required it.

In 2014, FFS Medicare, which has always operated under a “deliver and bill” methodology, will provide coverage to 70% of all Medicare beneficiaries. In this system, your prosthetist obtains a prescription from your physician, fabricates your prosthesis and then delivers it to you. After delivery, she submits the claim to Medicare for payment.

why is Medicare proposing this change in policy?

Unlike prior authorization in the private pay world, Medicare’s proposed rule isn’t really about confirming what Medicare covers. Rather, the proposed rule is intended to establish whether the actual claim materials satisfy Medicare’s requirements. Medicare’s logic is simple: (a) its data suggests that its paying for lower limb prosthetic claims that lack required documentation, (b) the current “deliver and bill” FFS system doesn’t allow it to review claim documentation beforehand, preventing it from addressing these inappropriate payments, so (c) “We believe a prior authorization process would ensure beneficiaries receive medically necessary care while minimizing the risk of improper payments and therefore protecting [sic] the Medicare Trust Fund.” While this appears to make sense at first glance, a deeper look at the issue indicates the data on which Medicare bases this proposal aren’t as clear-cut as it maintains.

Just to cite one example out of may possibilities, Medicare contends that 66% of all DMEPOS claims (more on that acronym in the next sentence) failed to meet its coverage requirements. The 66% figure applies to all DMEPOS – durable medical equipment, prosthetics, orthotics and supplies. DME and supplies are things like crutches, canes, wheelchairs, mattresses, and diabetic test strips – devices delivered to Medicare beneficiaries in much larger numbers than prostheses. Because the annual report relied upon by Medicare for this statistic contains no data breaking down prosthetic-specific error rates, it’s hard to know whether improper payments for prosthetics were anywhere near as high as those for DME and supplies.

It’s unlikely that potential data deficiencies like this will derail the push for prior authorization. But when Medicare proposes changes that could have a significant impact on amputees, you would hope that the foundation upon which the proposed rule is built would be rock solid. It’s not entirely clear that that’s the case here.

what effect will it have on you?

From the amputee perspective, it’s hard to find something positive in the proposed rule. The best way to illustrate this is with a hypothetical patient.

Jane is a new amputee who lost her right leg below the knee at age 65 to dysvascular disease. It has been 45 days since her amputation and she has been limited to a wheelchair since the surgery. Her prosthetist has already assembled the necessary paperwork to file her claim and determined that she is ready for delivery of her first prosthesis. Under the current system, the prosthetist obtains a prescription from the physician, documents Jane’s medical need for a below-knee prosthesis, orders the appropriate components, and delivers it to her as soon as he can schedule her for fitting. He then bills Medicare.

Current State Outcome: Jane has her prosthesis on Day 45 and the prosthetist is responsible for ensuring that Medicare pays him.

Now assume exactly the same clinical facts but with Medicare’s proposed prior authorization rule in place. On day 45 Jane’s prosthetist has all the necessary paperwork but isn’t delivering anything. Instead, he’s submitting that paperwork to Medicare for review. Let’s further assume that everything goes perfectly – they get prior approval on Day 55 and Jane receives her prosthesis 5 days later when her prosthetist can first fit her in his schedule. Jane’s absolute best-case scenario is that she sits in a wheelchair until 60 days after her amputation instead of 45.

Whether there’s a material long-term clinical impact on Jane due to an extra 15 days in a wheelchair isn’t exactly clear. We’d probably all agree it would be better for Jane to be in her prosthesis on Day 45 as opposed to Day 60. But under this system, that isn’t possible.

Best-Case Prior Authorization Scenario Outcome: Jane has her prosthesis on Day 60.

Now let’s walk through a more pessimistic – and, based on how Medicare’s contractors have reviewed prosthetic claims over the last 24 months – realistic fact pattern. Jane’s prosthetist submits the prior authorization request on Day 45. On Day 55, he receives notice from Medicare that it has denied his request for prior authorization, saying (a) without a great deal of specificity, the physician’s notes fail to satisfy Medicare’s coverage criteria and (b) he has failed to demonstrate the medical necessity of the prosthetic components prescribed for Jane.

The prosthetist contacts the doctor and gets what he believes to be additional appropriate documentation. He also updates his notes to further justify the components recommended and prescribed for Jane. He submits those for prior authorization on Day 60. Medicare responds on Day 80, informing him that it is still denying authorization because (a) the doctor’s notes don’t specifically state that Jane is “motivated to ambulate” and (b) Jane doesn’t have the functional “potential” to effectively use the components.

The prosthetist resubmits the authorization request a second time, now including a new physician note with the “motivation to ambulate” language included, new physical therapy notes addressing Jane’s functional potential and his own new records. It takes him a bit of time to assemble all this new information, as Jane needs to see the physician and PT, so he sends in the new paperwork on Day 95. On Day 115, Medicare finally approves the claim, and Jane receives her prosthesis on Day 120.

Here, it’s pretty clear that spending an extra 2 months in a wheelchair while Medicare screens paperwork will have both short-term and potential long-term effects on Jane’s rehabilitation. She now hasn’t been upright in 4 full months. She may well have developed a contracture in her knee joint. Her cardiovascular capability has degraded severely. Her sound leg’s muscle tone has also decreased. The chances of Jane becoming the kind of walker that her prosthetist originally envisioned are substantially lower. If she does get back to that level, it’ll take a lot longer. If she doesn’t, we can expect a greater number of physical and mental health issues to affect her in the coming months and years than she would have had otherwise.

Real Word Prior Authorization Scenario Outcome: Jane has her prosthesis on Day 120.

One other point on prior authorization: the system takes the authority for deciding what components are best suited for each individual patient out of the hands of the amputee’s health care team and gives it to claims processors. While Medicare officials might dispute this contention, compared to the current system it’s not even an arguable point.

Today, only the prosthetist and physician decide and document a course of treatment and a specific kind of prosthesis for each patient. The patient receives that prosthesis and the prosthetist must justify what she already delivered. But in a prior authorization world, if claims handlers don’t believe that the items prescribed for the patient are appropriate, they can effectively prevent the patient from receiving them in a timely fashion or, in a worst case scenario, at all. Prosthetists, faced with potentially lengthy delays and a patient who needs prosthetic care more and more with each passing day, may be forced to choose the path of least resistance. They may start putting Medicare patients in less appropriate components to get the prior approval, to provide the patient something.

Whatever the flaws of the current “deliver and bill” model, it has two strengths that prior authorization cannot replicate: (1) the health care team – the group with the best insight into the amputee’s clinical needs – has more control over what the patient gets, and (2) it allows amputees to receive more timely care.

conclusion

For all the horror stories about (a) national government programs generally and (b) health care specifically, I’ve always taken a  positive view of how fee-for-service Medicare treats people with limb loss. I’ve stated multiple times over the last decade that if I could choose any insurance for my prosthetic needs, Medicare would be close to the top of my list.

Unfortunately, I’m hard-pressed to see how this proposed rule helps amputees, and that’s because it’s really not about helping amputees: as Medicare freely acknowledges, it’s about preventing improper payments. Medicare may accomplish that goal, but there’s really no way to do it in a prior authorization system without putting amputees in a worse position than they are today.

Medicare is taking public comments on the proposed rule between now and July 28, 2014.

If you wish to submit comments so that amputees’ voices are heard in this debate, you can click here to submit electronically. When you get to the webpage, cut and paste the following reference into the large “Search” box in the center of the page: “CMS-2014-0070-0001”. This will lead you to a citation of the proposed rule. To comment, just click on the “Comment Now!” blue button to the right side of the citation.  Alternatively, written/typed comments can be submitted by regular mail to Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–6050–P, P.O. Box 8013, Baltimore, MD 21244–8013.