This was a big week for the specialty. The proposed coverage decision for lung cancer screening from CMS represents a big win for Medicare-aged smokers and former smokers, and radiology will play a key role in developing the new screening program. A 60-day comment period began on November 10 and considering the numerous stakeholders, there will be much to say.
Out of the gate, here are the eligibility requirements:
Radiologists. CMS proposes that participating radiologists be involved in the supervision or interpretation of at least 300 chest CT annually. Radiologists who do participate will want to become adept with the newly adopted Lung Imaging Reporting and Data System (Lung-RADS), the lung cancer screening equivalent of BI-RADS. The ACR has assembled a wide range of resources in a special section of its web site.
Facilities. According to the proposed coverage decision, an eligible LDCT screening facility is one that has participated in past lung cancer screening trials (there are not many of those) or is an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening; must use LDCTs with an effective radiation dose of less than 1.5 mSv; and must collect and submit data to a CMS-approved national registry.
Clearly, not every imaging facility need apply for this latest public health mission. Accreditation is not an unreasonable hurdle, but the list of minimum required data elements that must be submitted is quite extensive, numbering in the dozens (and represents a great opportunity for an enterprising IT company).
Exactly what kind of scanner can produce a diagnostic quality chest CT with an effective radiation dose of 1.5 mSv? Even that is aggressive, said John Boone, PhD, and Tony Seibert, PhD, of the UC Davis physicist brain trust. They believed the target range in the National Lung Screening Trial (initiated in 2006) was between 2 mSv and 3 mSv. A wide range of scanners was used by the original group of facilities, from 4-slice to the early 64-slice scanners, noted Seibert, a participant in that trial.
Nonetheless, the technical requirements are not highly exclusive. “Any modern CT scanner not more than five years old with tube current modulation and iterative reconstruction would be able to fairly easily meet the 1.5 mSv dose,” he said.
As currently proposed, patient self-referral will not be possible, because of the requirement that beneficiaries first be counseled on whether they are eligible for screening under the Medicare guidelines.
The bar appears to be set deliberately high, likely calculated to keep the brakes on what CMS does not want to become a runaway train. That’s not necessarily a bad idea at the start of a major new public health initiative.