On November 10, CMS proposed coverage of low-dose CT screening for high-risk patients, which was a major victory for the industry. "It completes the reimbursement picture for lung cancer screening," Mike Cwalinski, CT product manager at Siemens, told DOTmed News. "The impact of this is quite large - we've done some internal estimates that there are about 10.5 million people nationally that fall under the guidelines for USPSTF recommendation."

Siemens Healthcare submitted a 510(k) application to the FDA in October for their Lung Low Dose protocol, which will be available on all of their CT scanners.

It's one of many standard protocols that Siemens provides when they install a system. It factors in the rotation time, the pitch and mAs, which impacts dose levels. They have optimized the protocols to the right dose level in order to balance dose and image quality.
The radiation dose that the protocol generates varies depending upon which Siemens CT is in use. The average dose for all of the systems is .8 mSv per scan, according to Cwalinski. He added that the SOMATOM Force has a lower dose level than the average system.

Siemens was required to submit an application because their CTs only have approval for diagnosis, not for screening. "CTs have historically only been indicated used for diagnostic purposes and screening is technically a different indication for use," said Cwalinski.

Siemens did not disclose a date they expect to receive approval by, but said FDA usually takes 90 days to complete their review. DOTmed will write a follow-up article once it receives approval.

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