Diagnostics & Imaging Week Washington Editor

The Medicare Part B imaging controversy continues in the form of a provision found in the Obama administration's proposed budget for fiscal year 2010 which would require that physicians and hospitals work with a radiology benefits manager (RBM) before proceeding with some medical imaging procedures.

However, this development is running parallel with renewed concern over the impact of repeated imaging procedures on patients, thanks to a report by the National Council on Radiation Protection and Measurements (NCRPM; Bethesda, Maryland). According to a March 3 statement posted at the NCRPM web site, "in 2006, Americans were exposed to more than seven times as much ionizing radiation from medical procedures as was the case in the early 1980s."

The idea of requiring pre-authorization for scans has been raised in meetings of the Medicare Payment Advisory Commission. Bruce Steinwald, director of healthcare research at the Government Accountability Office said at a MedPAC meeting that in a study conducted by GAO consisting of interviews of private payers, the plans who were interviewed "reported that prior authorization . . . was the practice most important to managing physician use of imaging." Steinwald recommended that "CMS consider more front-end approaches, including prior authorization and privileging," but said CMS should "not necessarily [be] limited to those approaches."

One of the criticisms of how the Centers for Medicare & Medicaid Services pays for imaging is that it does not distinguish between state-of-the-art imaging equipment and older machines, which take more time to perform a scan. This issue is seen as important because CMS uses a payment rate that is based in part on the percentage of time during a work week that an imaging facility is performing scans rather than sitting idle. However, MedPAC also had heard testimony that utilization rates are often underreported.

A comment heard during the September MedPAC hearing was that post-claim reviews might suffice to tamp down inappropriate imaging, but it was also noted that the effort to reclaim imaging payments required of a pay-and-chase approach "would create an even bigger political problem" than pre-authorization.

In an undated statement, the American College of Radiology (ACR; Reston, Virginia) argues that "instead of using a for profit entity, whose only goal is to bring down costs, physicians themselves can be responsible for ensuring that the imaging they order for patients is appropriate." The statement notes that ACR "fought hard for a demonstration program for the use of physician-developed imaging appropriateness criteria in the Medicare Improvement and Patient Protection Act of 2008 (MIPPA)," which "is a better way to address utilization concerns and ensure that patients receive the most appropriate imaging studies."

FDA eyes MRI and metal in patches

The fields generated during magnetic resonance imaging (MRI) procedures can, like microwave oven energy, heat up metallic devices, but up to now, the metal content of transdermal patches has not been seen as a potential problem in this context. However, FDA has published a safety alert in connection with roughly half a dozen instances of patients with patches receiving mild burns when undergoing MRI exams.

Sandra Kweder, MD, deputy director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research said during yesterday's conference call that "some, but not all these patches contain aluminum or other metal" the consequences of which are that the patch could end up "conducting electricity and generating enough heat to cause a skin burn." She noted that "even a patch that is clear . . . may have a very small amount of metal that could overheat."

Kweder noted that the agency has "only a few reports" of such incidents, characterizing the resulting burns as akin to "bad sunburns." FDA is looking at how to approach the use of a warning label on a patch product, but has only started on the effort and has yet to determine whether the warning would go directly on the patch or on the product's package.

"Most MRI facilities ask patients to remove patches, but it may not be [a] uniform practice," Kweder noted. In response to a question about whether the agency could require that radiology technicians ask patients about patches, she said "we don't have any jurisdiction," but noted that the American College of Radiology (Reston, Virginia) "already has guidelines that recommend technicians ask about patches." Kweder said "we will be working with them and other stakeholders" to get the word out.

CMS announces apnea coverage

The Centers for Medicare & Medicaid Services announced Tuesday its reimbursement policy for testing to diagnose obstructive sleep apnea (OSA), and has opted to cover type II and III testing devices inside or outside of a sleep testing facility, meaning the test can take place in the comfort of one's own bed. CMS proposed such coverage in its announcement at the beginning of the year, and its review of comments and literature helped it quickly arrive at a decision.

Acting CMS Administrator Charlene Frizzera pointed out in the March 3 statement that anyone with OSA "face[s] significant risks for cardiovascular disease and other ailments," adding that the decision "establishes nationally consistent coverage and assures that beneficiaries who have sleep apnea can be appropriately diagnosed and referred for treatment."

The decision covers in-home tests for airflow, pulse oximetry and actigraphy, which is a measure of body movement during sleep. However, polysomnography, the modality requiring the attachment of enough leads to the patient's scalp and body to render a visage not unlike something from a Clive Barker movie, must still be conducted in a sleep lab.

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