It seems crazy to me to "bundle" wound care services. From what the article below states, CMS want to "cap" how much one can bill for a wound care patient per "episode". Among other things, this Cap would also include debridements and skin substitutes. With the high cost of skin substitutes as well as the nature of wounds usually necessitating multiple visits over weeks to months and serial applications of skin substitutes, CMS better come up with a realistic "cap" is that is what they intend to do because I don't think that $4,000 is nearly enough.

If something like this goes through, what's to happen? Well, I guess less wound care providers will be doing wound care because it simply will not be cost effective and I fear that amputation rate will rise. Alas, I'm confident CMS doesn't see things this way, as all they care about is finding ways to cut reimbursements and eliminate codes and procedures which are "overused" or too costly for them. Call me cynical, but I don't think this is the appropriate approach to stimulate more research into efficacious and cost effective ways to heal wounds.

New CMS policies will lead to 'big change' in wound care practices, analyst says

New Medicare and Medicaid reimbursement practices within the next year will significantly change preferred treatment methods for wounds that are common in long-term care settings, according to a new market analysis.

The Centers for Medicare & Medicaid Services has indicated it will switch from a fee-for-service model to a bundled payment system for wound care services. This will put pressure on providers to use more cost-effective wound care therapies, says Jason Napodano, a sell-side equity research analyst with Zacks Investment Research.

Under the existing payment model, skin substitute products are a go-to treatment for chronic wounds if debridement and/or negative pressure therapy does not succeed, Napodano noted in his analysis, posted Monday on the website Seeking Alpha. Physicians currently are reimbursed separately for grafting procedures and the associated skin substitute products, but this is likely to change in 2014, Napodano wrote.

CMS has proposed reimbursing $874 total for the grafting procedure and related product. This would not cover the costs associated with the skin substitute products, according to the analysis. Industry sources say they see CMS capping the entire reimbursement for healing a chronic wound such as a diabetic foot ulcer at $4,000 per episode, Napodano told McKnight's.*

“The leading products are on their way out,” Napodano wrote. Less costly alternatives are already poised to capture more market share, he argued. He identified several products whose use could grow significantly.

 

Alex

- The opinions expressed are my own personal views and are not representative of any past nor current employer.

  • Comments (14)
  • Page 1 of 2 Next
  • The new reimbursement practices from the Centers for Medicare & Medicaid Services (CMS) is dealing a devastating financial blow to conventional treatment providers for non-healing chronic wounds. The U.S. government is currently paying $25 billion per year for physician services and products for wounds that are not healing. This number will grow exponentially as our population of baby-boomers age. In ten years 100% of this population segment will be over 65 years of age. In response to this potentially bankrupting financial drain with poor clinical results, CMS has publicized its intent to switch from a fee-for-service model to a bundled payment system for wound care services with a cap on wound care of $4,000 per encounter. The American Medical Association (AMA) and three dozen medical professional associations representing most of the clinical stakeholders in wound care understandably voiced a vehement objection to this move in a letter to Marilyn B. Tavenner, administrator for CMS dated 8/29/2013 (https://www.auanet.org/common/pdf/advocacy/advocacy-in-action/AMA-Letter-to-CMS.pdf). Apparently, those who represent the community of wound care providers are focused on treatment modalities for recalcitrant wounds such as skin replacement materials, amniotic membranes, hyperbaric therapy, airflow dynamic dressings, enzymatic ointments and other expensive treatments. They claim that the new caps will not even cover the cost of some of the materials, forcing providers to abandon the wound care industry altogether because cheaper modalities with improved outcomes don’t exist.

    Of course, this bold statement that no other viable alternative to treatments costing thousands of dollars per encounter exists in treating chronic wounds begs the question, “What about electromagnetic therapy?” This technology, which started with the Diapulse Corporation of America in 1959, now has more evidence of safety and efficacy that any other wound care modality on the market bar none. Guo, et al (2012) conducted a meta-analysis of the results of 186 case control studies conducted over 2 decades showing consistent efficacy in wound healing and pain management from unrelated researchers located around the world. We also now have more information about how this technology works with animal model studies like the one of Pan, et al (2013). So why does the AMA insist on making a last ditch effort to maintain the old way of doing things which is clearly not working? Preserving a $25 billion industry is a compelling motivation to hang on to the belief that a cheaper technology that heals the otherwise non-responsive wounds is a myth. Otherwise conventional wound care providers would have to acknowledge that all of their innovations have been obsolete compared to PEMF technology that has been waiting in the wings for its over-due recognition for 57 years.

    However, this state of mass denial about what is really state-of-the-art in wound care notwithstanding, the CMS is likely not going to reverse itself from the move to cap out wound care reimbursement, which will leave providers scrambling for the cheaper-to-use, more effective “non-existent” PEMF technology. The other mind-blowing fact is that CMS has for the last ten years been approving reimbursement for PEMF technology for the healing of chronic wounds that don’t respond to conventional treatment for the first thirty days. So the reality is that the cheaper more effective alternative that the AMA claims doesn’t exist is already built into the reimbursement system. The motivation to avail of this reimbursable technology didn’t exist until know because when comparing a reimbursement of $400 to $4,000 per encounter with no end in sight to an average of $135 per visit for 1-3 months until healed, the former seems much more interesting to stakeholders. Moreover, CMS officials, having always been loath to pay for treatments that don’t work, have finally come to their senses to force providers to take a closer look at the cheaper modality that works. This also may change the standards of care so that the failure to inform the patient of all available treatment options could lead to professional and institutional liability.

    References:

    Guo L, Kubat NJ, Nelson TR and Isenberg RA (2012). Meta-Analysis of Clinical Efficacy of Pulsed Radio Frequency Energy Treatment. Annals of Surgery; 255(3): Pp. 457-67.

    Pan Y, Dong Y, Hou W, Ji Zhiyu et al (2013). Effects of PEMF on microcirculation and angiogenesis in a model of acute hind limb ischemia in diabetic rats. Bio Electro Magnetics; 34(3): Pp. 180-8

  •  There is no way in ^%$^ that you can treat these wounds with skin substitutes after this goes through.  What I am saying is that: that policy in which you cannot use skin substitutes, will minimally affect the rates of wound healing and will not affect amputation rates unless doctors force the amp rate up when they are done playing with the $4k budget. That would be pure evil.

    Most of these studies show at best, wound closure rates 3 weeks earlier than standard wound care in healthy patients.  Generally about 12 instead of 15 weeks.  As stated above the research has a very low reliability factor due to research methods and bias. 

    We like these things, we want to think that we are on the frontier of medicine, but these are wheels reinvented.  There was little wrong with skin grafts except the donor site.  A donor site is well worth it to save a limb, just as the $1400 ApligraftLest we digress into hammertoe implants---another cult of corporate influence (That I use with some regularity).

    You could make $400-$600 taking and placing a single skin graft or make $200, Applying $1400 worth of Corporate Wound Companies product.  What do you think they are trying to steer you into?

    Those of you that feel these products actually close stalled wounds, What do you do with your uninsured?  Do they not get better without these products? Do you force them to pay for 6-10 Dermagrafts? My uninsured wound patients get better, without skin substitutes. Knock on wood. 

    Show me a plantar ulcer healed with a skin substitute without a TAL and/or surgical saucerization and I'll show you the recurrence in a few months.  Show me the same wound without the skin substitute with the proper deficits addressed and that patient will heal and never have a problem again.

    Another aside.  I actually worked in Vincent Falangas MD (Dermatologist responsible for much of Apligraf's FDA trials)wound clinic a few times between 1998 and 2000 (as a resident).  I never understood why he was always convinced that Apligraf was the reason for his stasis wounds to heal.  Every patient was wrapped with a profore kit.  I had and still have many patients get better without Apligraf and good compression dressings.  It has never impressed me much, though I do want it available for limited applications.

    After a miserable failure to actually find significant fraud in the system (The spent more to find fraud then they found after they were done refunding the unfounded claims), Medicare is finally looking for the schemes occurring within the rules that run up costs.  I suspect we will see many more similar restrictions.  If we want to use Medicare when we are 70 years old (Projected collection age by me), we should seriously think about what we need versus what we want and maybe find an affordable middle ground.

    Marc

     

  • Marc,

    The way I interpreted it was that the $4,000 cap was "all inclusive" meaning debridements, office visit, grafting procedures, and grafts (each Dermagraft / Appligraf costs about $1,200), etc.; so I think the "cap" could be very well hit after 6-8 weeks of conservative wound care and then having to implement "advanced" modalities in the event that the ulcer has not healed by then. The "window" stipulated by the proposed legislation is per "occurrence", so I guess its from the time the patient presents with that specific ulcer until it is healed.

  • I am not claiming to know how this legislation will consider the $4000 cap.  But I doubt you could hit that in private practice with debridements and offloading.  Maybe I am missing a code, but at 50-80 bucks a visit for the type of chronic care you are describing, It would take at least 50 visits to hit 4 grand per patient.

    Dave is somewhat making my point.  You do not necesasarily loose a leg from having an open wound. 

    Is the cap lifetime or per year, 3 years?  What do they do with you when you hit your cap?

    I thought Dr Sherman and Gotlieb wanted gov't intervention.  You do realize that means a rationing of resources by the government?

    I would think that revascularization, osteo and osseous deformity or Charcot would be separate diagnoses not hitched to the 4K cap.  I believe we are talking about a chronic healthy stalled wound, the kind that should heal if the patient is properly offloaded, vascular status, nutrition status and infection are properly addressed.

    For what it is worth, my mother actually does have a chronic wound of 2.5 years (not foot) and all the miracle measures have done nothing but run up her bill...because she has underlying issues that are not under control.

    Wounds that don't heal have non wound issues that need to be fixed, often  too much pressure; subclinical osteo or weak perfusion.  Most recalcitrant wounds need surgery not Apligraf. It can help after you have fixed the underlying problems. Spend the money on the real problems first!! If that is done there is very little need for skin substitutes. 

    As much as I do not want the government telling me when to throw in the towel on a patient, I do think most wounds can and should be treated for under $4000.00.  But that means the government is taking our toys away.  How many times can I use a versa jet before hitting the cap....Oh well, back to scalpels, but I love that thing.  Maybe the dentist can use it as overpriced dental floss?

    Marc

  • It'd sure be worth more than $4,000 if it were my mother's foot. I mean that literally as my mother is a frail diabetic with neuropathy. If G-D forbid she were to get an ulcer I'd be all over that in a heart beat with all modalities available.

  • 1. I've been advising the use of city tap water for wound cleansing ever since that report came out. It works just fine. Well water is another matter.

    2. Gauze and honey were state of the art for the pharoahs. I think we can do better.

    3. Especially in the VA clinical results count. We are constantly evaluated for results and healing rates. Cost does come into play, maybe not by me but certainly that the people who's budgets my choices impact.

    4. Cap on wound care reimbursement? I'm not sure how I feel about that. I've seen some patients literally for years with ulcer treatments, off-loading, re-vascularizations, advanced wound care products, etc. They keep that leg. Some just barely but that leg is still there. There is still something one could call a foot. What is that worth? How much money is it worth? A lot if it was mine, I think.

    Dave Gottlieb, DPM personal opinions only

  • Quote:

    Marc, I see your logic and rational. I'd just like to comment on one thing you said: "Even in the VA’s, doctors want to get their hands on emerging technology and products without regard for the cost."

    This is currently not an accurate assumption, it may have been in the past, but certainly not now. We use approved vendors whom have government contracts which are negotiated and which are usually lower as compared to what they are sold for in the private sector. Furthermore, we are often subject to cost analysis and utilization reviews and there'd better be good reason (clinical justification supported by peer reviewed data) for you to be using a particular product on a given patient. Finally, there are published internal clinical guidelines which serve to guide which products may be used when and these guidelines are usually enforced by the purchasing agent. For example, I can't go straight to a Dermagraft without first having tried offloading, local conservative wound care (6 weeks minimum), and assessment of infection and vascularity.

     

    - The opinions expressed above are my own peronal opinions and observations and are not representative of any currnt or past employer.


    First, I have not been in a VA for about 15 years, So I am speaking from past and limited experience.

    Second, Those standards are the same ones that are considered unreliable by other gov't studies--see above.

    Third, good!!! use discretion to keep these modalities available to everyone when and if they are needed.

    Fourth, Come on!! You know when you are approved to use bioengineered skin, you are thinking...yeah baby, I heal wounds with bioengineered skin, what did you do today?

    Marc,

    The opinions expressed above are not my own they are elicited by mind controlling aliens set to invade on Halloween. I just wanted a cool disclaimer too...  So I could be different, like everybody else.

  • Marc, I see your logic and rational. I'd just like to comment on one thing you said: "Even in the VA’s, doctors want to get their hands on emerging technology and products without regard for the cost."

    This is currently not an accurate assumption, it may have been in the past, but certainly not now. We use approved vendors whom have government contracts which are negotiated and which are usually lower as compared to what they are sold for in the private sector. Furthermore, we are often subject to cost analysis and utilization reviews and there'd better be good reason (clinical justification supported by peer reviewed data) for you to be using a particular product on a given patient. Finally, there are published internal clinical guidelines which serve to guide which products may be used when and these guidelines are usually enforced by the purchasing agent. For example, I can't go straight to a Dermagraft without first having tried offloading, local conservative wound care (6 weeks minimum), and assessment of infection and vascularity.

    - The opinions expressed above are my own peronal opinions and observations and are not representative of any currnt or past employer.

  • Quote:

    I have seen evidence of remarkable results using bioengineered skin, collagen scaffold and amniotic tissue products to heal wounds that fail traditional conservative treatment.  I think that one should always apply the personal test to the question of what is too expensive - what would I want done for my mother ?  Of course we, as a society, need to make rationing decisions about who gets what.  But criticising current advanced wound care technologies as a group as being too expensive - that make no sense to me.  They are improving people's quality of life.  What IS too expensive for your mother ?


    I am not saying these things are useless, I am saying that there is no price controlling mechanism built into the blank check reimbursement policies.  These policies stimulate overutilization, justified by marginal improvements and thereby stifle improvements in competing developments.

     The effects of adding 50-100,000 dollars in wound care give you marginal wound care improvement rates. 

     How many studies do we have on 5 year closures after Biologics vs naturally healed wounds? Wouldn’t that be useful information? Am I the only one with patient coming from wound care centers and 10 dermagrafts without proper offloading and recurrent ulcerations?

     In 14 years I have never seen a BKA when a patient had circulation, and was on antibiotics, regardless of the length of time that the patient had the wound.  Just me? Maybe. So why do we constantly justify these products by their supposed ability to close a wound 3 weeks earlier thereby preventing amputation?  It is not true. Wounds that will heal, will heal without an amputation.  Ischemic, malnourished or bioburdened wounds will get fixed or amped.

     Do you believe wound care choices are presently based on reimbursement incentives or patient need? Even in the VA’s, doctors want to get their hands on emerging technology and products without regard for the cost.   Thus, Universal health care does not solve this, the incentives have to be, such that doctors and suppliers compete for the best results at the lowest price.


    Cochrane and gov't Studies:

     

    Hospitals target-marketing wound centers to build profit statements. http://www.ncbi.nlm.nih.gov/pubmed/15901060

    Rees

    -----

    This review (six studies involving a total of 375 participants) identified no research evidence to suggest that alginate wound dressings are more effective in healing diabetic foot ulcers than other types of dressing.

    ------

     Existing reviews have not found evidence that one dressing type is more effective than other types in healing foot ulcers in people with diabetes. This review (157 participants) confirms that currently there is no research evidence to suggest that foam wound dressings are more effective in healing diabetic foot ulcers than other types of dressing –

     -----

    The reviewers concluded that where tap water is high quality (drinkable), it

    may be as good as other methods such as sterile water or saline (salty)

    water (and more cost-effective), but more research is needed

    -----

     An evidence review prepared for the Cochrane Collaboration (Bergin et a., 2006) concluded: "Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness.  Trials are needed to determine clinical and cost-effectiveness and long-term outcomes including adverse events."

     -----

    Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance

     ------

    Although the evidence for the comparison of Dermagraft vs. saline moistened gauze came from 3 studies including 530 patients and had a precise result of a direct outcome, we judged the strength of the evidence to be only low because the studies had a moderate risk of bias.56,62,65…… The other comparisons were from studies with moderate risk of bias and imprecise results; these were judged to have an insufficient strength of evidence grade……  The results of these studies may not easily translate to everyday clinical situations.  http://www.ahrq.gov/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf

    ---Translation:  doctors love new toys and are easily convinced that this makes them the best doctor in town. So they manage to tweak a study to augment or outright BS the results.

    Marc


     

     

     

  • I probably wasn't as profitable in my private practice as some of my colleagues because I treated everyone as if they were my mother or my father. They all received the same level of care and received the same access to products, even if I ended up being at a net loss. As Jeff mentioned, a single payer system may work here, provided the living cell products (as an example) were to be easily and readily available to all patients.

    Unfortunately, until some Congressman's mother falls ill, traction won't be gained because that's what it'll take for these legislators to pay attention; why? because everyone wants what's best for their mother.

  • Page 1 of 2 Next