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New Law Mandates Disclosure for Neurology Imaging


doi: 10.1097/01.NT.0000383491.70944.81
Departments: Policy Watch

Neurologists who own high-technology imaging equipment are scrambling to comply with a new law that requires them to notify their patients of alternatives to the scanning unit down the hall.

At issue is a provision of the Patient Protection and Affordable Care Act that applies specifically to non-radiologist physicians who provide PET, CT, and MR imaging services in their offices. When those physicians order image tests for their own patients, they must inform the patients in writing that the services can be obtained elsewhere and provide patients with a list of imaging services in the area where the patient lives.

Failure to comply with the mandate means clinician imagers will not be reimbursed by the Centers for Medicare and Medicaid Services (CMS) for imaging services.

“It's a huge burden, both for the CMS, which is responsible for Medicare oversight, and for the practices themselves,” said William G. Preston, MD, associate clinical professor of neurology at the University of California-Irvine School of Medicine and chair of the AAN Neuroimaging Section.

The primary burden for neurology and other physician practices is interpreting the vague wording in the new law.

The law requires that physicians disclose to their patients that they have an ownership interest in imaging equipment used in their office. That part is easy; providing a list of providers “in the area in which the patient resides” is not.



According to that wording, neurologists who treat patients in a wide geographic area would have to provide a list of imaging alternatives from many communities — and patients who travel across the country for neurologic care would have to be notified of imaging options in their hometown.

“It is almost impossible for referring neurologists to be experts in every community that their patients come from,” Dr. Preston said.

Unlike many parts of the health reform act that become effective at dates in the future, the self-disclosure rule for non-radiologists who own imaging technology actually went into effect Jan. 1, 2010.

The AAN — and many other organizations — have asked the Department for Health and Human Services to clarify how neurologists should comply with the law.

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Health care attorney Thomas R. Neal said that because complying with the Jan. 1 date is impossible, some observers think the mandate will only be effective when CMS finalizes the rules for this provision of the reform legislation. Thus, some physician practices may opt to ignore the self-disclosure mandate until the regulations are published, he said.

Neal, who chairs the health care practice group at Kreig DeVault, a law firm based in Indianapolis, said that might not be the best approach.

Because of enormous reform-related workload for CMS, those regulations may not be forthcoming for months, he said. Rather than ignoring the law for the time being, a safer approach would be for a practice to give patients a list of imaging providers in its own community. That would demonstrate a good-faith attempt to comply with the law until regulations are published.

Dr. Preston said the Coalition for Patient Centered Imaging, a group that includes neurologists, cardiologists, and other clinician imagers, is asking the CMS to clarify several points related to the mandate:

  • What is the definition of “area in which the patient resides”?
  • Must the list of imaging providers in that area be comprehensive?
  • If no imaging providers are available in a patient's immediate community, how does a physician comply with the mandate? “If the patient comes from Mount Whitney (CA), where there aren't any scanners, what are our obligations?” Dr. Preston said. “Do we have to find some other town the patient can go to?”
  • What, if any, is the physician practice's liability for the list of alternative providers?
  • “We have a mandate here — and sanctions to be enforced if we don't comply — to in fact point patients to providers that we have no idea if they're good, bad, or indifferent,” said Dr. Preston, a member of the board of directors for the American Society of Neuroimaging.
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The self-disclosure rule advances two major trends in medicine. The first is transparency, a key component of value-based health care, in which patients choose health providers based on the best combination of quality and cost.

Public and private payers are pushing for value-based health care. Thus, mandating that physicians notify their patients that they have a financial interest in imaging equipment — and that the patient is free to choose another imaging provider — is an incremental boost to that cause.

The other trend is the government's ongoing attempt to identify and reduce the inappropriate use of high-tech imaging studies, which are often cited as an example of wasteful spending that fuels rising health care costs.

On this matter, the American College of Radiology (ACR) is pitted against neurologists and other non-radiologist physicians who own their own imaging equipment.

The ACR, which asserts that non-radiologist physicians who own imaging equipment are a primary source of inappropriate use, advocated for the self-referral disclosure rule.

“We feel that it is a good first step to addressing the problem of financially motivated self-referral,” said ACR spokesman Shawn Farley.

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Non-radiologist physicians are allowed to own and use imaging equipment in their offices through the “in-office” exemption of the federal Stark laws, which prohibit physicians from referring their patients to a facility in which they have an ownership interest. ACR's goal is to get that exemption removed.

“Savings will only be realized if the in-office ancillary loophole is closed,” Farley said.

The federal government and insurance companies join ACR in complaining that self-referral leads to inappropriate use of imaging equipment. But Dr. Preston rebuts that idea, pointing out that radiologists self-refer when they ask a patient to return for additional images to confirm a finding or gather additional information.

“The people who complain that self-referral contributes to a vast inappropriate utilization are not only wrong, but they're usually from non-clinician specialties,” Dr. Preston said.

In 2008, the Academy issued a position paper opposing efforts to prevent neurologists from providing imaging services and any restrictions on self-referred imaging practices and equipment ownership.

Carl Ellenberger, MD, a neurologist in Mount Gretna, PA, specialized in reading neurology-specific images before retiring, in part because of the longstanding turf battle between radiologists and clinician imagers.

He bristles at “radiologists who think they alone are qualified” to read scans. While neuroradiologists are well-qualified to support neurologists, general radiologists have little training in neurologic images, he said. By contrast, neurologists who specialize in reading scans can evaluate whether the right study was performed in the proper way to answer a specific neurology-related question — and they know what to look for to help the treating neurologist make a diagnosis.

“Neurologists (who read scans) participate in the whole investigation of the patient's situation,” he said.

Both Dr. Ellenberger and Dr. Preston see the Congress inclusion of the self-disclosure rule as a move in a disturbing direction.

“What this is heading towards, in our humble opinion in the clinician imaging field, is an increased oversight and possibly an ultimate denial of the in-office exception for Stark restrictions,” Dr. Preston said.

He views neuroimaging as an integral part of the everydayâ practice of neurology. “Any restriction of neurologist neuroimaging would be to the distinct detriment of our specialty's future and best patient care,” he said.

©2010 American Academy of Neurology