Message to Medicare: Whoa, Nellie!

Last week, Medicare proposed nine additional “do not pay” conditions, several months before implementing the first eight. I like the concept of not paying for preventable adverse events, but this new list is a case of too far, too fast.

In my previous review of the new policy (here and in this article), I described four conditions that should be met for an adverse event (AE) to be included on the “do not pay” list:

  • Evidence demonstrates that the AE in question can largely be prevented by widespread adoption of achievable practices.
  • The AE can be measured accurately, in a way that is auditable.
  • The AE resulted in clinically significant patient harm.
  • It is possible, through chart review, to differentiate an AE that began in the hospital from one that was “present on admission” (POA).

Take, for example, catheter-related bloodstream infections (CR-BSI), one of the eight original AEs slated for “do not pay” implementation by the Centers for Medicare & Medicaid Services (CMS) later this year. CR-BSI has a generally accepted definition and causes significant mortality and morbidity. POA is only an issue for patients transferred from other healthcare facilities; most will have fever or leukocytosis as clues to an infection. Most importantly, a group of relatively straightforward interventions has been demonstrated to nearly eliminate these infections, both in small studies and in Michigan’s Keystone project involving over 100 ICUs. Given this, there is strong justification to withhold additional payments when a patient suffers a CR-BSI.

But check out the new list of nine proposed “no pay” diagnoses:

  • Surgical site infections following certain elective procedures
  • Legionnaires’ disease
  • Extreme blood sugar derangement (including hypoglycemia and diabetic ketoacidosis)
  • Iatrogenic pneumothorax
  • Delirium
  • Ventilator-associated pneumonia (VAP)
  • Deep vein thrombosis/Pulmonary Embolism
  • Staphylococcus aureus septicemia
  • Clostridium difficile associated disease

Before you get indignant about this list, remember that the idea is that the hospital will not be able to claim the AE as a “complicating condition,” which would increase its Medicare DRG payment. The hospital will still get paid for the hospitalization – it’ll just be as if the AE never happened for the purpose of DRG calculations.

Of course, that’s small consolation when the treatment of the AE costs the hospital tens of thousands of dollars, as it does in cases of pulmonary embolism and staph septicemia. And it is a near certainty that any AEs that Medicare puts on “no pay” lists will be the subject of public reporting, making the hospital with high rates of delirium and DVT look unsafe (even if it’s not).

With that in mind, as I look over the list of nine, I can’t find a single entity that meets my four conditions. Yes, many surgical site infections are preventable with perfect technique and antibiotic prophylaxis, but they suffer from non-standard, highly variable definitions. Ditto VAP. I can’t say I’ve seen a lot of hospital-acquired diabetic ketoacidosis, but I can live with the hospital not being paid extra if I ever do. Hypoglycemia – this measure will discourage hospitals from trying to achieve tight glucose control. As I noted previously, a more holistic quality measure might assess the amount of time that patients are kept in normoglycemic range, with points deducted for hypoglycemic episodes.

That’s it for the reasonable ones. What’s up with Legionnaire’s disease, which is usually community acquired? If it ends up on the list, you can bet that every pneumonia patient will have a Legionella antigen checked on admission to catch POA, a real waste. Delirium — expect it to vie with “early decubitus ulcer” for the title of America’s most common admission diagnosis. And does anybody believe that all cases of DVT or C diff colitis are preventable? I did a quick PubMed search on “Clostridium difficile” and “prevention” and could not find a single intervention trial demonstrating that the rate of this infection could be lowered in hospitalized patients.

I can’t argue with the premise – many of the AEs on this list are no doubt partly preventable with more religious implementation of certain safety practices (for example, for C diff, avoiding unnecessary antibiotics and adhering to strict infection control practices with suspected cases). But they are nowhere near ready for prime time. Adoption of this new list will lead to all kinds of gaming, POA shenanigans, wasted effort on preventive strategies with no supportive evidence, and nasty unintended consequences.

Most importantly, while the initial list of eight appeared to represent a good faith effort by CMS to move the safety ball down the field, the new list looks like a Medicare cost-cutting effort clothed in the garb of patient safety. It is a major league overreach, and CMS should hit the pause button before it goes too far.


  1. shadowfax on April 28, 2008 at 5:52 pm

    Well Said!  I couldn’t agree more, and said much the same thing in my blog post about this a week or so ago — though you said it better.  But you forgot one thing. The proposed rule is open for public comment until June 13, and you can go to

    And follow the instructions for “Comment or Submission” and enter the file code CMS-1390-P to submit comments on this proposed rule.

  2. Joe Hospitalist on April 28, 2008 at 10:46 pm

    Bob, who makes these regulations?

    “the new list looks like a Medicare cost-cutting effort clothed in the garb of patient safety”.

    Boy, you said it. That’s what I thought of the first list. This one just goes over the top though. Have any of these people examined how other countries get better results on a fraction of our budget. I bet it’s not by cutting reimbursement for compications which are clearly beyond the control of the hospital or physician.

    How about trying a return to good old primary care medicine. Maybe some incentives for less procedures (cost a lot) and more incentives for cerebral work (costs a lot LESS)! Try lowering the costs of prescription medications etc.

    Every hospital I know is doing everything they can day in and out to simply survive without layoffs. These regulations will only make that harder. We have a growing population and not enough beds.

    Where is this train heading?

  3. btruax on April 29, 2008 at 1:52 pm

    I agree with Bob’s comments about removing Legionnaire’s disease from the list. Delirium will also likely fail to make the final rule list.

    The problem with delirium is not that it’s not important to maintain surveillance for delirium but rather in what the evidence base says about interventions. If the Hazards of Hospitalization Questionnaire tool developed by the authors (Fernandez 2008) can be validated in several settings or populations, it has tremendous potential to help us prevent complications such as delirium. Not only is delirium associated with increased morbidity and mortality, but it is also associated with prolonged lengths of stay and excess costs (Leslie et al. 2008). At least 2 studies have demonstrated that multifactorial interventions targeted at elderly inpatients at risk for delirium may shorten hospital length of stay, reduce duration of delirium, and reduce mortality (Lundstrom et al. 2005; Naughton et al 2005). The Lundstrom study showed that a multifactorial intervention program reduces the duration of delirium, length of hospital stay, and mortality in delirious patients. The Naughton study showed that a multifactorial intervention designed to reduce delirium in older adults was associated with improved psychotropic medication use, less delirium, and hospital savings. So there does appear to be some evidence that such programs make sense from quality, patient safety, and financial perspectives. However, the interventions are not likely to significantly reduce the number of patients identified with delirium. In fact, a good tool might actually increase the number identified. There are also many factors that are truly not under control of the hospital and staff that may precipitate delirium. So our feeling is that hospitals should not be penalized unfairly for the occurrence of delirium.


    Fernandez HM, Callahan KE, Likourezos A, Leipzig RM. House Staff Member Awareness of Older Inpatients’ Risks for Hazards of Hospitalization. Arch Intern Med. 2008;168(4):390-396. (Go to study).

    Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-Year Health Care Costs Associated With Delirium in the Elderly Population. Arch Intern Med 2008; 168(1): 27-32. (Go to study). 

    Naughton BJ, Saltzman S, Ramadan F, Chadha N, Priore R, Mylotte JM. A multifactorial intervention to reduce prevalence of delirium and shorten hospital length of stay. J Am Geriatr Soc. 2005; 53(1):18–23. (Go to study).

    Lundström M, Edlund A, Karlsson S, Brännström B, Bucht G, Gustafson Y. A multifactorial intervention program reduces the duration of delirium, length of hospitalization, and mortality in delirious patients. J Am Geriatr Soc. 2005; 53(4): 622–628. (Go to study). 

  4. Eric Siegal on April 29, 2008 at 9:18 pm

    Based upon scanty supporting evidence, CMS mandated 4 hour door to antibiotic administration for patients with suspected pneumonia. In response, ERs all of the country starting treating heart failure, pneumonitis and ILD with levofloxacin. And now CMS wants to ding hospitals for c diff infections, which may have been in part precipitated by their insistence on blind adherence to a faulty measure. “Kafka-esque” doesn’t even begin to describe this.

  5. pprescot on April 29, 2008 at 11:28 pm

    So, who is responsible, really, for these ridiculous “rules?” The FDA, OSHA, EPA, etc have been politically compromised by the present administration, which supports nothing for docs or people. After all, they can always go to the ER.

  6. mizzg on September 10, 2008 at 12:00 am

    Great blog. This is my first exposure to your site. I must say…I love it.I am a nurse in grad school for nursing education. This is my first blog assignment and I want you to know that I WILL be sharing this site with my classmates, great information with lots of perspectives.

    Comment on the proposed AE list. The first word that came to mind was RANDOM. This is a frequent word I hear from students and my teen children when I come up with hair-brained loosely connected (disconnected I should say) verbage. You are right on target with this one. As a nurse I can tell you the ripple effects on staff development departments is like a tidal wave when this stuff comes out. Everyone had to rush to inservices on catheter insertion when that hit the dreaded list. But, legionaire’s disease , does this mean engineering will be sampling all the AC ducts? (now it’s their turn to run around). EBP nursing research will have to respond to this new list along with medicine to keep the fingers from pointing in our direction.Thank you for an interesting read.

  7. ArkieRN on October 7, 2008 at 4:27 am

    People in the hospital have the right to make decisions for themselves. Among these is to refuse advice and treatments. Many people are diabetic (type 2) because they don’t adhere to a proper diet. In the hospital they will have family sneak food, eat off roommates trays or demand to be brought more food (even against medical advice). Other diabetics (usually type 1) may not want to eat even though their insulin has already been given and will refuse feeding tubes. And we can’t very well force feed them.

    So how is it that the hospital becomes responsible for blood sugar extremes automatically? That is totally ridiculous!

  8. George- Healthcare Safety Consulting on June 22, 2012 at 9:13 pm

    In a response to the previous comments, how can hospitals best manage their patients’ needs and expectations with respect to the guidelines, best practices, and regulations? Thanks for the informative post!

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