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News: Medicare's Overly Burdensome, Dangerous Rules on Sepsis

Aycock, Ryan, MD

doi: 10.1097/01.EEM.0000542270.40369.54
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Dr. Aycock is an emergency physician at West Florida Hospital/TeamHealth in Pensacola, FL, and a clinical assistant professor with Florida State University's College of Medicine.

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A patient was admitted to the intensive care unit with severe bacteremia when I was in my first year of training as an emergency medicine resident. At the time, we had to meet national resuscitation goals by continuously giving intravenous fluids to her so we could meet an arbitrary cutoff measure known as the central venous pressure. (Crit Care Med 2008;36[1]:296.) After her sixth liter of saline, she developed pulmonary edema and had to be placed on a mechanical ventilator. We then had to give furosemide to remove all of the fluids we had just administered. Her case is not unique.

The Centers for Medicare & Medicaid Services issued a performance measure known as Severe Sepsis and Septic Shock Early Management Bundle, also called SEP-1, in 2015 to combat life-threatening infections. Sepsis is a devastating medical condition loosely defined as organ dysfunction caused by infection. (JAMA 2016;315[8]:801.) It is associated with high death rates and accounts for billions of dollars of health care spending each year. CMS began requiring hospitals to combat sepsis by ordering certain tests and administering particular antibiotics from an approved list.

The required actions in SEP-1 bring about “decreases in organ failure [and] overall reductions in hospital mortality, length of stay, and costs of care,” according to CMS. This performance measure, while noble in intent, has only led to unnecessary testing and treatment, is not based on scientific evidence, and may eventually harm patients who receive particular medications unnecessarily. (Ann Intern Med 2016;165[7]:517.)

SEP-1's definition of sepsis is outdated and no longer used by the medical community. (West J Emerg Med 2017;18[5]:951.) As an emergency physician, I must use this outdated convention to evaluate patients presenting to the hospital, guess if they might have sepsis, and then immediately begin a treatment protocol that includes bloodwork, antibiotics, and intravenous fluids. Timely administration of antibiotics is associated with better patient outcomes, but nothing else in SEP-1's required action list has been shown to improve sepsis mortality. What's more, none of the articles CMS references in its performance measure demonstrates decreases in mortality or cost. (Am J Respir Crit Care Med 2017;195:A5014; http://bit.ly/2G8ii05.)

National Institutes of Health researchers methodically evaluated the available literature on sepsis treatment, and found that CMS violated its own grading criteria for scientific evidence when creating this performance measure. (Ann Intern Med 2018; doi: 10.7326/M17-2947.) To heap on additional insult to injury, the three largest randomized controlled trials ever performed on sepsis bundles confirmed that no survival benefit was seen in using protocolized treatment algorithms on all patients with sepsis. (N Engl J Med 2014;370[18]:1683; N Engl J Med 2014;371[16]:1496; N Engl J Med 2015;372[14]:1301.)

On the antibiotics side, SEP-1 requires that I administer one of 14 approved antibiotics to any patient presenting with sepsis, whether or not that particular medication has any chance of treating the disease. As a result, I usually end up prescribing two antibiotics: the one that CMS requires that does no good and the correct one. As a result, patients might be harmed from receiving unnecessary drugs. A working group with representatives from the American College of Emergency Physicians, the Infectious Disease Society of America, and the Society for Critical Care Medicine has come out against this antibiotic list, calling it “not appropriate.”(Clin Infect Dis 2017;65[9]:1565.)

To meet the requirements of SEP-1, physicians must document 63 elements of the patient's evaluation and medical care to receive credit for completing the bundle. Missing just one item on the list results in failure to comply, which means that Medicare will then withhold reimbursement. (J Emerg Med 2017;52[1]:109.) Instead of reducing costs of care, these new regulations force hospital administrators to hire people to manually review each chart to ensure that all elements have been documented. (Am J Respir Crit Care Med 2016;194[2]:139.) The real lunacy comes when we realize that a physician who appropriately treats a patient with sepsis and saves his life can be called a bad doctor for not generating enough paperwork.

The end result of this performance measure is that patients are going to have to undergo unnecessary tests and treatments, all of which they are going to be forced to pay for, just so we can meet a metric that has never been proven to work. Medicare should review its regulations, particularly the Severe Sepsis and Septic Shock Early Management Bundle. If the goal is to save lives and reduce costs, then we should drop expensive practices that are difficult to implement and can potentially harm people.

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