Sepsis is a brutal killer. It often begins after a microorganism is released into your bloodstream, spreading to far and wide organs, releasing deadly toxins along the way. In response, your body releases its own toxins, chemicals designed to kill the invading organism, but which all too often harm your body as well, leaving you a victim of friendly fire.
To survive sepsis, you need great medical care, in a hospital staffed with clinicians who know how to get you the right treatments at the right time. But in recent years, health care regulators became concerned that hospitals weren’t giving patients the right care at the right time. So in 2015, Medicare began tracking and promoting the quality of sepsis care in the United States. He created a reimbursement program called (get ready for a catchy name) the “SEP-1 bundle.” The program tracks whether hospitals do a timely job, after a diagnosis of sepsis has been made, to:
- Taking blood cultures
- Measuring blood lactate, a chemical that reflects whether body tissues are getting enough oxygen
- Administration of broad-spectrum antibiotics
- Giving IV fluids to raise blood pressure
And if those things don’t improve quickly, the program also looks at whether doctors:
- Review lactate levels
- And switch to more powerful blood pressure boosters, called “vasopressors”
One final aspect worth noting about SEP-1: If a hospital fails to do just one of the things mentioned above, it is rated as providing deficient care for that patient.
This is micromanaging those Medicare friends. Don’t you think? But all that micromanagement came with good intentions and was based on strong evidence that everything Medicare tracked was important to patient outcomes.
But does the program work? Early results are coming in and it appears that hospitals paid attention to the new reimbursement rules. Since the rules were introduced, we have seen:
- A 50% increase in lactate measurement
- A 30% increase in the use of IV fluids
- A 10% increase in the prescription of a broad-spectrum antibiotic
There’s just one problem: If you were to draw a graph of death rates before and after the SEP-1 program, it would look flatter than a Nebraska highway.
In an editorial explaining these disappointing results, Michael Klompas and Chanu Rhee of Harvard Medical School speculate why this well-intentioned reimbursement reform led to unintended consequences.
Initially, it prompts doctors to prescribe antibacterial drugs, even when doctors suspect, or even know, that the cause of a patient’s sepsis is not bacterial. Remember, a worldwide viral pandemic broke out shortly after this program began. In a COVID patient, antibacterial medications often do more harm than good, bringing all the side effects of any powerful antibiotic but little, if any, benefit.
Additionally, the program expects aggressive use of IV fluids to help raise blood pressure. But such aggressiveness can harm patients who have conditions such as congestive heart failure, where fluid overload can worsen their signs and symptoms.
I don’t know the best way for programs like Medicare to improve outcomes for patients with serious conditions like sepsis. Adjusting reimbursement to promote “guideline-compliant care” seemed like a good idea. But such changes risk fostering biased care that undermines patient outcomes. In addition, it creates more red tape, more administrative costs for hospitals and more paperwork/computer entry tasks for doctors.
In designing the package, CMS did what any good quality improvement effort should do: structured the incentives based on the best available clinical evidence, combined with input from expert clinicians. However, as the data show, even these efforts were not enough to prevent the incentives from reversing.
Bottom line: Even well-designed quality improvements can fail. We must evaluate these programs and be willing to revise them, or abandon them when they make things worse.