Headache patients who come to the ED could die or become permanently disabled for lack of a brain CT to detect hemorrhage or tumors, all because of a new Medicare quality rule poised to take effect Jan. 1.
That may sound overly dramatic. But anger over the coming rule echoed through many sessions of the American College of Emergency Physicians scientific assembly in San Francisco this week.
Robert C. Solomon, MD, a member of ACEP's board and a member of the faculty in the emergency medicine residency program at Allegheny General Hospital in Pittsburgh, is one doctor who insists that death and permanent disability are exactly what will happen if the proposed rule takes effect.
Without a CT, aneurysms that should be surgically repaired will go unseen, he says. Subtle bleeds will go undetected. "Patients are going to suffer harm as a result of this," he told me in an interview.
Starting Jan. 1, the Centers for Medicare & Medicaid Services wants to apply the Quality Data Reporting Program to cover orders of brain CT on beneficiaries whose chief complaint is headache in the absence of an obvious traumatic event.
Exclusions would apply for patients with dizziness, paresthesia, lack of coordination, subarachnoid hemorrhage or abrupt onset "thunderclap" headaches, those who undergo lumbar punctures, or those admitted or transferred to an acute care hospital.
CMS's final rule is expected in the next two weeks. Eventually, ACEP officials say, hospital scores will determine Medicare payment adjustments, up or down, because that has been the CMS' stated goal.
Medicare officials declined to discuss ACEP's objections, saying they'll be addressed in the final rule. But in reading the fine print, it's obvious the agency wants to contain these scans, which many published papers say are ordered far too often without medical need. At between $775 and $2,775 each, the costs adds up.
Additionally, the agency refers to the growing safety concern with CT radiation doses much higher than those from X-rays.
According to one published paper, 2% of ED patients – 136 million visits a year at last count – have headache as their chief complaint. That can yield a lot of head CTs.
The language in CMS' proposed rule is more detailed.
ED physicians, "because of time constraints and lack of ED physician familiarity with headache presentation" have a "lower threshold for ordering neuroimaging for headache," the agency says.
"Because of this lower threshold, the measurement of the use of CT Brain in the ED for patients with a diagnosis of atraumatic headache can help to raise the awareness of the need for quality improvement on the appropriate use of CT brain imaging in the ED and, as a result, improve patient safety through reduction in unnecessary radiation exposure."
"Unnecessary or duplicative studies are inefficient and detrimental to the patient because CT exposes the patient to higher doses of radiation than conventional x-ray and increases the patient's risk for cancer," the agency's rule says.
Elsewhere, the agency referenced a 2007 report in The New England Journal of Medicinethat of 62 million CT scans performed per year (including those of the brain) "a third are unnecessary, resulting in patient safety issues including unnecessary radiation and contrast material exposure, and the danger associated with 'false positive' findings.' "
Yes, ACEP's leaders say, they know doctors order too many CT scans. But to start requiring that they be counted in QDRP, published on HospitalCompare and to use this data to reject or adjust Medicare claims, is just way too premature, Solomon says.
It even goes against the Affordable Care Act, which say that CMS' quality measures must be set forth by one or more national consensus building entities, such as the National Quality Forum, ACEP says.
That would be great if already happened, Solomon says. But it hasn't.
The proposed rule deals with that by saying "We anticipate that (the measures) will be endorsed by the NQF."
Solomon says brain CT is a huge dilemma for ED doctors because the scans rarely reveal clinically significant findings, but when they do, they're really important. But science has not developed a clinical decision-making tool that would help them "be more judicious."
"It'd be nice if a well-designed, big study found five or six symptoms that – if the atraumatic headache patient does not have – will indicate they won't have anything serious and you can refrain from doing the CT," he explains. But such a tool does not yet exist.
"If CMS wants to make decisions aimed at reducing use of technology in order to reduce spending of money, those decisions should be based on good science. But CMS is pretending that we already have a criteria we can use, and they're wrong," he says.
ACEP has other concerns: In an Aug. 30 letter, ACEP told CMS that "Because the guideline is for older adults, there is no scientific basis to suggest there is a patient safety issue – there is no evidence that a CT scan of the head increases the risk of cancer or other issues."
The letter added that the reporting requirement will use claims data, which doesn't include "important information in the patient chart justifying the scan." In ACEP's "dry run" of the rule at 20 hospitals in 12 states this May, 64% of those cases that CMS criteria would have labeled 'inappropriate' "had a measure exclusion documented in the medical chart that was missed in the administrative data."
Solomon says it's too early to tell how many patients will suffer harm their doctors were afraid to order a brain CT.
"But I can tell you that if you're the patient in the ED with a subarachnoid hemorrhage and you have permanent disability, your family is going to take a very dim view of CMS' guidelines," Solomon said.
Of course, there's a possibility that ED doctors will do the right thing, even if it makes their hospital look like it's guilty of overuse.
But Solomon thinks many physicians will hold back. "If I ordered a CT scan and it's normal, this is not going to be in compliance with the quality measure, and I'm going to be called to account for this and I'll undergo chart review.
"That will start to influence physicians' thinking, 'Well, should I even go down this road and get this CT because I'm just going to get in trouble?'
These are the physicians who are going to miss a diagnosis."
Solomon says some doctors will order the CT, and if it's clear, continue with a lumbar puncture that will qualify the case for the reporting exclusion. And that will get them off the hook. However, Solomon foresees a problem with this approach too.
"The patient will say 'No thanks. Nobody's going to stick a needle in my spine.' Well, then the physician will say, 'Now what?' " he said.
The whole episode has left Solomon somewhat bitter.
"You look at the way CMS approaches quality and value, you can see that their focus really is on cost," he says. "Their focus really is in finding things they don't have to pay for."