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"Never Events" Might Lead to "Never Treatment”

The efforts to decrease the incidence of preventable errors in medical treatment


The efforts by the Centers for Medicare and Medicaid Services (CMS) and the Federal Government to improve the quality of healthcare and decrease the incidence of preventable errors in medical treatment (known as "Never Events") should be applauded. This is a difficult and complicated but important task. The American Association of Hip and Knee Surgeons (AAHKS) and other organizations share CMS's goal of promoting high quality, safe and effective care for all patients. We have met with CMS on numerous occasions to help promote these efforts and make constructive comment on the proposed rules.

Furthermore, we support a payment system that advocates quality care, including withholding payment for certain "Never Events" that should truly not occur, such as operating on the wrong limb. Every effort should be made to eliminate preventable hospital-acquired conditions. The AAHKS is concerned that if CMS includes complications that are not always reasonably preventable on the hospital-acquired condition list, this may have the unintended negative affect of restricting patient's access to and quality of care.

One significant area of concern that is currently proposed for inclusion on the "Never List" for implementation on October 1, 2008 is the occurrence of Deep Venous Thromboembolism and Pulmonary Emboli (DVT/PE). The AAHKS supports the routine use of DVT/PE preventive treatments in orthopaedic surgery and believe that this is the standard of care.We also support the findings and recommendations of the National Quality Forum and the Joint Commission’s partnership that helped to develop these quality standards.

CMS is already taking additional positive steps to further reduce the incidence of DVT and PE by implementing additional hospital quality measures specifically focused on the prevention of this complication. We agree that DVT and PE are major quality, health, and resource concerns for patients, hospitals, and CMS. However, we have several issues regarding the designation of these conditions as “reasonably preventable” hospital acquired conditions.

Currently, there is no scientific evidence that DVT/PE is “reasonably” preventable in certain high risk orthopaedic procedures. The evidence is very clear that patients suffering traumatic injuries, fractures, and major joint replacement procedures such as hip and knee replacements are at the highest risk of developing DVT/PE compared to all other medical or general surgical procedures.

Also it is well documented that obesity, increased age, a history of cancer, decreased mobility or delay in surgery increases the risk even further. These are common health problems found in this patient population. Obesity is the fastest growing diagnosis in the Medicare age population today. In the absence of appropriate preventive treatment, a patient undergoing a major orthopaedic procedure has a 40-80% risk of developing a hospital acquired DVT/PE as compared to a 10-40% risk for other patients.

This risk can be decreased in the orthopaedic patient with appropriate preventive treatment, but not entirely eliminated. Therefore, this does not meet the criterion of “reasonably preventable” as mandated by Congress. In addition, certain patients are not appropriate for the needed medical preventive treatment due to the risk of major bleeding. Therefore, it is important to balance the risks of both DVT/PE and the alternative risk of major bleeding.

The complicating risk factors are numerous and CMS has the capability of implementing a risk adjustment and/or appeals process for this guideline that could help to prevent hospitals from being wrongfully penalized while at the same time ensuring availability of the best care for our patients.

It would be terribly unfortunate to have a so-called “Never Event” lead to a “Never Treatment” result, if hospitals become less willing to accept patients at risk for such events to avoid the potential financial penalty for results they could not entirely prevent. To eliminate this risk, CMS should remove DVT/PE from the “Never Event” List—at least until a risk adjustment or appeals process has been developed and validated. Ensuring access to care for our patients is our highest priority!

Dr. Parsley is Chair of the Health Policy Committee of the American Association of Hip and Knee Surgeons.

Source:  American Association of Hip and Knee Surgeons (AAHKS)

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