News Headline: Lung Screening Registry: Useful or Unrealistic
Outlet Full Name: Med Page Today
Author: Crystal Phend
A national registry for lung screening is on the table as the Centers for Medicare and Medicaid Services (CMS) weighs coverage Wednesday, but such a registry could amount to a delaying tactic that undermines life-saving potential, some warned.
“It would be a barrier to accomplishing screening and would be used as a way of slowing implementation of screening and limiting access,” argued Douglas Wood, MD, chief of cardiothoracic surgery at the University of Washington in Seattle.
“Those of us whose whole lives are dedicated to lung cancer management, and who see this as the biggest thing that will impact lung cancer survival in my career or lifetime, see that as unfair to patients,” he explained.
But advocates for a national registry say it would be critical to ensuring quality care in the community.
Why Track Screening?
The National Lung Screening Trial (NLST) sparked recommendations for screening and now coverage deliberations by showing a 20% lung cancer mortality reduction that yielded a nearly 7% boost in overall survival.
But the NLST trial was largely done at major academic medical centers using specific protocol and experienced radiologists.
“Screening is a process, it’s not just a scan,” explained Lynn Tanoue, MD, director of the lung screening program at Yale Cancer Center. She cautioned that there’s no certainty that the national rollout will achieve the same mortality reduction.
And it’s a process fraught with potential pitfalls for patients.
Will community centers maintain strict adherence to protocols that minimize radiation exposure? Will unnecessary follow-up for the high rate of false-positive scans and surgeries for benign disease multiply beyond that in NLST? What about the inevitable screens done on lower risk individuals who don’t fit NLST criteria?
“All of that can only be answered in the context of a national database,” Tanoue told MedPage Today.
Moreover, it’s human nature to do better when watched, noted Douglas Arenberg, MD, director of lung screening at the University of Michigan in Ann Arbor.
A registry offers a chance for self-correction as centers look at their performance benchmarked against the rest.
For example, when a Michigan registry started tracking coronary artery calcium CT scans, radiation doses and interpretation were all over the map, Arenberg noted.
“All the variables that were being tracked began to equilibrate across all these institutions to far more advantageous levels, and radiation dose was one example of that,” he told MedPage Today.
For just such reasons, the U.S. Preventive Services Task Force called for a registry when it recommended lung screening for annual low-dose CT screening for high-risk individuals, ages 55 through 79, who have a 30 pack-year history of smoking or who have quit in the past 15 years.
CMS is considering a registry as part of the national coverage determination, which will be deliberated at an advisory committee meeting.
“Whether there is a registry or not is part of what’s being decided,” Donald McLeod, a communications officer for CMS, told MedPage Today. “We can’t comment publicly until it’s done.”
There is precedent, as when the FDA and CMS made a national registry a stipulation for approval and coverage of transcatheter aortic valve replacement (TAVR).
Because the key professional societies were already on board with the idea, what’s now known as the joint American College of Cardiology/Society of Thoracic Surgeons TVT Registry was already up and running before CMS decided on coverage.
“I think the crucial thing is to establish very close relationships between the professional societies and the regulatory agencies,” one of the architects of that database, David Holmes, Jr., MD, of the Mayo Clinic in Rochester, Minn., told MedPage Today.
However, none of the key stakeholders appear to want to take on a national registry in lung screening.
The American College of Radiology, arguably representing providers with the biggest stake in CT lung screening, supports only data collection on screening of patients outside NLST criteria through existing registries, such as those of individual health systems and the International Early Lung Cancer Action Program (I-ELCAP).
The American Thoracic Society has no specific plans aside from giving a sort of “official thumbs-up” to registries of groups like the VA and Kaiser Permanente, said Renda Wiener, MD, MPH, of Boston University and chair of the ATS committee drafting a statement for the organization on lung screening.
The National Cancer Institute plans only spot coverage too.
“We’re very interested in seeing a registry go forward from the VA hospital system and from HMOs, and we’re planning to develop a common data element set so everyone collects similar information,” Barnett Kramer, MD, MPH, director of the division of cancer prevention at the National Cancer Institute, told MedPage Today.
The PROSPR program (Population-Based Research Optimizing Screening Through Personalized Regimens), currently used for multisite assessment of breast, colon, and cervical cancer screening, could be brought into play, noted Paul Doria-Rose, DVM, PhD, an epidemiologist at the NCI.
There are also plans for initial pilot work within the NCI-funded Cancer Research Network of nonprofit integrated healthcare systems, he said.
“At least our immediate plans are to try to find some kind of representative systems that we could take a look at what’s going on within those systems,” he told MedPage Today.
“There is never an intent to be fully national coverage.”
The Lung Cancer Alliance won’t be starting up a full national registry either, but does have a network of 172 centers with screening programs that have agreed to adhere to its framework, one portion of which calls for participation in data collection.
That voluntary registry will be rolled out on a pilot basis within a few weeks and then expanded, said Laurie Fenton Ambrose, president and CEO of the group.
The cloud-based database should be less expensive than a traditional registry and allow for open use in research, she told MedPage Today.
The Society of Thoracic Surgeons (STS), which has extensive experience running registries, said it had no plans for a national registry in lung screening either.
Requiring one as part of Medicare reimbursement would be a very bad idea, argued Wood, immediate past president of STS.
“I understand the good intentions of those who might be promoting it, but it gets into pragmatic implementation that ends up being unrealistic in terms of broad implementation,” he told MedPage Today.
For one thing, the scope would potentially be so large.
Fewer than 6,000 Medicare patients had TAVR in the first 18 months after approval; whereas the population eligible for screening under the USPSTF recommendations is on the order of 7 to 9 million.
“The total numbers of people who would be eligible for lung cancer screening would so far exceed the size of the existing registries CMS has maintained, it would be a completely different scale,” Doria-Rose said.
The price tag at that scale would be prohibitive, Wood said.
The TVT Registry is funded by $25,000 first-year user fees and $10,000 for participation each subsequent year. But that procedure garners a much higher reimbursement from CMS (around a median $50,000 to $57,000 per procedure) than anything lung screening is likely to see.
The screening fees paid by patients out of pocket have been in the range of only $50 to $400, although reimbursement for subsequent follow-up testing and lung cancer treatment would be substantially higher.
A registry isn’t required for other large-scale cancer screening, such as breast and colon, Wood noted.
“The evidence now for lung cancer screening is actually more compelling than that for breast cancer screening in terms of the measured benefit and the number of patients that need to be screened per life saved,” he argued. “It seems unfair to limit patients at risk of lung cancer from access to screening now that we have evidence of its benefit.”
What might be reasonable is to implement a mandatory registry for the much smaller group of patients screened by extended criteria guidelines with less evidence, such as those of the National Comprehensive Cancer Network (NCCN), Wood said.
He’s set to argue for coverage of that group at the CMS hearing.
Under the Affordable Care Act, private insurers will be required to cover the USPSTF-recommended screening without cost-sharing beginning Jan. 1, 2015.
“We don’t want to have the unintended consequence of providing screening access only to those patients who manage to live in an urban area and are well-connected or wealthy enough to get access to an academic medical center,” which presumably would be able to afford participation in a registry whereas the rural and community centers serving the bulk of the poor and elderly might not, Wood argued.