Tuesday, June 02, 2009

CMS : Flying Against the Headwind of Reality

When good science, good medical care, and common sense sit athwart government bureaucrats, who wins? I think all of you know the answer, but it bears repeating.

One of the hidden dangers that lurk for patients -- particularly those who have undergone surgery or who have had trauma -- is the risk for developing a venous thromboembilism. I have written about this in the past, so I won't bore you with the details. Simply put, we try to aggressively treat patients with prophylactic measures to try to avoid the development of VTE, using medications (Heparin or Lovenox), early ambulation, and sequential compression devices. There are a few problems with this, however:

  • Some patients cannot be mobilized, due to injury, ventilator-dependence, etc.
  • Some patients cannot be given chemoprophylaxis, with injuries to the central nervous system, spleen, or liver which could bleed when they are given medications that interfere with clotting.
  • Some patients will develop VTE, regardless of whether or not they are treated with appropriate prophylaxis.
That's right, Kemo Sabe, some patients will develop a deep vein thrombosis or pulmonary embolism no matter what we do. While we may have prior knowledge of a hypercoaguable state in some patients, more often than not it becomes apparent only after the fact. Sometimes the hypercoaguable state is temporary, associated only with the episode of trauma, and sometimes it is genetically predetermined. But a really smart trauma surgeon at the University of Colorado has developed a test that appears to be able to detect patients who are at a significantly higher risk for VTE.

In the May issue of Surgery News (link is to a pdf file), Dr. Jeffry Kashuk describes the test, known as rapid thromboelastography (r-TEG), using a device manufactured by Haemoscope. For those of you who are interested in the chemical processes involved, read the article for the details that were presented at the Central Surgical Association's annual meeting (which I suspect will be published formally in the not to distant future). The bottom line? -->
  • 19% of the hypercoaguable patients experienced a thromboembolic event despite chemoprophylaxis, compared with none of the patients who had normal coaguability.
  • Evidence of a hypercoaguable state predicted thromboembolic events with a 100% sensitivity and 45% specificity in patients who received chemoprophylaxis.
Cool. If this pans out in larger studies, it will provide us with another tool to treat patients in a more tailored fashion. For example, we may be quicker to place a temporary vena cava filter in some patients, or give them greater than standard doses of Heparin until the r-TEG results normalize. Alternately, we may be able to avoid placement of some IVC filters in trauma patients who cannot be given chemoprophylaxis if their r-TEG tests do not demonstrate a hypercoaguable process. Once again, this has the potential to be a very useful tool if it pans out.

Whoa, Nellie. Stop right there. According to the Baghdad Bob the Centers for Medicare & Medicaid Services, venous thromboembolism should never happen! It is, in their parlance, a "never event." That's sort of like saying that flat tires, frozen pipes, or computer crashes should never happen. It flies in the face of reality, an intentional offense to those caring for patients in this country. I say intentional, because the goal is not improving care, but denial of payment. (More on "never events" can be found here and here.)

So, we know that some patients are at an increased risk for VTE, and some are going to get VTE even with currently appropriate prophylactic measures. This test may help us identify some of those patients, and start trials on treating them differently. CMS, ignoring the science and accumulated weight of decades of clinical evidence, by declaring this to be a "never event" has rendered this type of investigation moot, as they simply will not fund care for "never events."

Let this be a little introduction to government-run health care.