Week #11 Change Agents in the Healthcare Sector

In this weeks blog we will be focusing on change agents in the healthcare sector. A Change agent is person, business, or organization that advocates and assists in implementing change. These change agents come in various different forms but for this particular discussion we will be focusing on a particular society that acts as a change agent for wound care related health policies. This week we will be focusing on the Wound, Ostomy and Continence Nurses Society (WOCN), which is an international nursing society founded in 1968 (WOCN, 2014). This particular society has made it their mission not only to improve clinical nursing skills through clinical, research and educational means to advance practice but also through policy advocacy (WOCN, 2014). This week I had the chance to speak with a few representatives from the health policy division of the WOCN to discuss their perspectives on the policy change that CMS has finalized in regards to the reimbursement for the use of skin substitutes. This is the conversation I had with the WOCN:

WOCN

Question #1 – What is the WOCN’s opinion on the newly changed policy addressing the CMS reimbursement model for the use of biologicals (Fee-for-service vs. bundled payment)

Answer #1 – The organization has concerns about CMS’s approach to reimbursement for “skin substitutes.”  CMS’s initial proposal to restructure its reimbursement model, which was included in the CY 2014 Payment System Update for Hospital Outpatient and Ambulatory Surgical Centers, would have unconditionally packaged all drugs and biologicals that function as supplies or devices in a surgical procedure beginning in the CY 2014.  WOCN was opposed to this proposed rule and suggested in comments that CMS recognize that there are a wide variety of products available within the “skin substitute” category and that each has a different clinical function and treatment protocol.  Thus, lumping all products into the same payment methodology would discourage use of those products that were more expensive even if they were clinically appropriate.

Question #2 – The goal of this policy change was to encourage healthcare providers to use high quality evidence-based care to increase healing time and decrease overall cost. Does the WOCN believe that this policy change will accomplish this goal?

Answer #2 – The policy will almost certainly decrease costs, but could do so at the expense of quality evidence-based care.  CMS has based their bundling premise on the theory that “skin substitutes” function as wound dressings as opposed to skin grafts; we disagree with this basic premise and argue that advanced biologic products used for wound treatment act more like human grafts than simple wound dressings.  However, these advanced products do not function as a substitute for skin, rather as a wound treatment effectively creating three separate categories.   It is reasonable to think that advanced biologic products which require FDA 510(k) approval and substantial research and investment, not to mention advanced handling and storage requirements in the clinical setting, would have a higher cost than typical wound dressings.  We do not believe that bundling all products in a widely varied category such as wound treatment is high quality evidenced-based care.

Question #3 – The WOCN argued against CMS’s initial decision to lump all products into the same bundled reimbursement category, which resulted in the division of skin substitutes into two tiers. Was the WOCN satisfied with this outcome? If not, what modification to the policy would the WOCN like to see?

Answer #3 – While we were happy to see that CMS did ultimately recognize that not all wound treatment products are created equally and created a two-tier system, we remain concerned about the unintended consequences of this system.  Most notably, even within the tiers you will have products that vary widely on cost yet are reimbursed on one of two reimbursement rates.  WOCN is currently evaluating the impact of the two-tiered model and will be working with CMS to reevaluate its proposals for FY 2015.

Question #4 – An argument has been made in the past emphasizing that the cost of biologicals outweighs the benefits gained from the use of this therapy. What position does the WOCN take on the efficacy of skin graft therapy? Does the WOCN believe that healthcare providers will be swayed to use other less expensive therapies due to this policy change?

Answer #4 – The concern of the WOCN has always been the availability of alternative therapies for patients who have large defect wounds that cannot heal without an advanced therapy. Split thickness skin grafts are an ideal method for closure for some of these wounds, but there are some situations that make skin grafting difficult. The true biologic skin substitutes meet a unique need for those patients who are not candidates for “surgery” to harvest and place a split thickness graft, or who have limited tissue options to provide the donor graft or who simply cannot afford a surgical procedure (even if the cost to them is only their co-pay or deductible).

We have maintained that the two recognized biologic skin substitutes (re: actually harvested human cells that have been rigorously processed) have been shown to be quite effective in healing many such wounds. Although there is not a preponderance of research to supporting this, the case studies are numerous. And in the current health care environment, they are cost effective. Surgery is expensive, even outpatient surgeries.

Our belief is that the policy change, with its 2 tiers of products, is misleading and potentially can lead to use of less effective therapy. It is our hope that healthcare providers will review this policy change critically and recognize that not all “high” level products really meet the definition of biologic skin substitutes. Many of these describe themselves as “dermal or acellular” scaffolding for wound healing but only two really address the inclusion of fibroblast and live cells to “grow” the tissue needed to cover the wound.

As mentioned earlier in this blog, the WOCN took an active role as a change agent by acting upon their concerns and advocating for a revision of the new reimbursement model imposed by CMS (WOCN, 2013). Change agents, such as the WOCN, play a vital role in advancing health policies to ensure that evidence-based practice may be maintained within the clinical setting so that patients may continue to receive the best possible care from their health care provider. In conclusion of this weeks blog I wan to say thank you to the WOCN for continuing to fight for the patients best interest and for taking the time to answer my questions.

Reference

Wound Ostomy and Continence Nurse Society (WOCN). (2014). About US. Retrieved from: http://www.wocn.org/?page=about_us

Wound Ostomy and Continence Nurse Society (WOCN). (2013). CMS Publishes 2014 Outpatient Prospective Payment System and Ambulatory Surgical Center Final Rule. Retrieved from: http://www.wocn.org/news/150253/CMS-Publishes-2014-Outpatient-Prospective-Payment-System-and-Ambulatory-Surgical-Center-Final-Rule.htm

 

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2 Responses to Week #11 Change Agents in the Healthcare Sector

  1. rdschlabach says:

    Hi Peter,
    Excellent information and interview! I particularly found the comments about evidence-based practice in relation to decreasing costs enlightening. Best evidence does not correlate to lower costs based on my experience. New cutting edge treatments and medications can be shown to be significantly more effective in treating a condition or illness, yet since it is “new”, rarely is it the cheapest. For example, I just read an article a few weeks ago about two new drugs for Hepatitis C – Sovaldi and Olysio. Clinical trials have shown cure rates of 80% to 90% with a lot less complications. This is a huge leap in the treatment of Hep C and all the complications of the disease. Except … they are extremely expensive! Sovaldi is around $84K for a course of treatment and Olysio is around $66K. (1) They may be a better treatment option, but payers are bulking at the high cost. Hep C affects 3 million people in the US, so these new drugs can help a lot of people.

    Both of our policies seem to have failed to do what they originally intended. I know mine is still undergoing changes. I’ll be interested in seeing if your policy will also continue to be changed.

    Robyn

    (1) Terhune, C. & Brown, E. (2014). Prices of new hepatitis C drugs are tough to swallow for insurers. Los Angeles Times, March 9, 2014. Retrieved from http://articles.latimes.com/2014/mar/09/business/la-fi-hepatitis-c-drug-costs-20140310

  2. Peter,
    I cans see that the WOCN is a “grass roots” change agent when it comes to skin grafting legislation. I wonder how CMS made their decision to change the reimbursements? What informant did they use, or what professional did they consult to make this change if any? How soon will the new proposed legislation they are pushing for come into action? I agree that not one product is suitable for all patients. It seems the dollar is the bottom line here.

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