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All good quality intentions don’t always do good, CMS measure suggests

By Jean DerGurahian, August 10, 2009, Modern Healthcare

Mandated quality measures don’t always improve quality—if a recent move by regulatory officials is any indication. A clinical process once considered to help boost patient safety and quality has been removed from guidelines and federal quality reporting requirements because of research that shows it could cause significant harm or death to some patients. The move concerning the use of beta blockers only raises more questions about evidence-based research and quality reporting efforts.

The process that hospitals were required to perform as part of their quality reporting measures to the CMS and the Joint Commission has been removed in the final inpatient prospective payment system for 2010. The move formally retires the measure known as AMI-6, which requires providers to give heart patients a beta blocker on arrival. Research since 2005 from the American College of Cardiology and the American Heart Association—both of which in 2007 had removed AMI-6 as a guideline for cardiologists—has shown giving beta blockers to patients with a history of heart failure could increase their risk of going into the potentially fatal condition known as cardiogenic shock, according to an explanation of the retirement posted on the CMS Web site.

But the CMS, which had known about the research since 2005 when it was first conducted, had already taken the unprecedented step of unofficially stopping the measure last year because of that increased risk. The Joint Commission, also aware of the ongoing research, stopped requiring the AMI-6 measure at the same time as the CMS.

CMS officials said this was the first time that the agency had effectively ended a measure outside the statutory rulemaking process. Providers were becoming confused about when to provide the beta blocker and when to document why they could not in an exclusionary section of reporting forms, according to the official who spoke on the condition she not be identified per CMS policy.

Both regulatory bodies say they acted quickly to respond to the changes in the American College of Cardiology and American Heart Association guidelines. The reporting measures required are based on guidelines developed by the field, and those measures are constantly being evaluated as the science changes, said Jerod Loeb, executive vice president for research at the Joint Commission. The accrediting body worked with a team of professionals to study AMI-6 and how to ensure the proper use of beta blockers, he said. “This was all done very collaboratively across all organizations.”

Loeb added that the measurement process requires constant study and evaluation. "These measures are not meant to dictate how medicine should be practiced,” he said. “When we or anyone else puts a measure in place, we don’t carve it in stone."

Still, providers feel pressure and some obligation to follow measures to the letter when they know their performance is going to be reported and scrutinized based on them, said Sandeep Khosla, chief of cardiology for Sinai Health System, Chicago. "We had a lot of frustration with this particular AMI-6."

In most cases, giving a beta blocker to a patient will be effective, Khosla said. But to be able to make that call within 24 hours of a patient’s arrival—especially in an emergency situation when doctors might not have all information on hand—is a challenge, he added.