Preliminary Decision by CMS to Cover Lung Cancer Screening

Roxanne Nelson

November 10, 2014

The Centers for Medicare & Medicaid Services (CMS) has made a preliminary decision to cover lung cancer screening with low-dose computed tomography (LDCT) for eligible patients.

The decision was welcomed by a number of professional societies, including the American Thoracic Society, the Lung Cancer Alliance, and the American College of Chest Physicians.

In April, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) voted against recommending national Medicare coverage for annual screening for lung cancer with low-dose CT in high-risk individuals. Although the MEDCAC vote isn't binding, their ruling ignited intense pushback from healthcare professionals, patient advocates, and professional associations. More than 40 medical societies have urged CMS to provide coverage for older adults. Even politicians have entered the fray, with members of the US House and Senate asking CMS to reimburse for screening.

"LDCT has been shown to reduce mortality when used to screen individuals who are at high risk for developing lung cancer because of their age and smoking history," Charles Powell, MD, chief of pulmonary, critical care, and sleep medicine at Mount Sinai Hospital in New York City and chair of the American Thoracic Society's thoracic oncology assembly, said in a statement.

"While there is some risk of overdiagnosis, it is outweighed by the mortality benefit that has been demonstrated with screening targeted groups of high-risk patients," he said.

Some experts have advised caution and better data before CMS offers coverage for lung cancer screening. Last month in JAMA Internal Medicine, for example, Stephen Woolf, MD, MPH, from Virginia Commonwealth University in Richmond, and colleagues argued against initiating Medicare coverage for low-dose CT screening at this time. They urged that "prudence argues against launching a national screening campaign until current concerns about definitive net benefit are resolved."

For CMS, "this means not covering low-dose CT screening until better data become available for older adults who are screening in ordinary [nontrial] community settings," they said, noting that screening outside of trial conditions is less likely to be restricted to high-risk smokers and qualified imaging centers with responsible referral protocols.

But Dr Powell emphasized that thoughtful implementation of lung cancer screening, combined with strict attention to monitoring of screening program adherence to standards for centers of excellence, can help minimize the associated harms of screening.

But some of those recommendations are already part of the approach that the CMS outlined in its provisional decision. For example, screening centers must meet certain criteria to be accredited to provide the service, such as having participated in previous lung cancer screening trials like the National Lung Screening Trial or in an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening. Data must be collected and submitted to a CMS-approved national registry for each LDCT lung cancer screening performed.

"Routine utilization of smoking cessation and multidisciplinary management will help to maximize the benefits," he added.

Approximately 4 million Medicare beneficiaries fit the eligibility criteria for screening, according to the Lung Cancer Alliance. In a release, the organization points out that the CMS decision is aligned with the recommendations submitted to CMS in September by a coalition that included nearly 100 other professional societies, public health organizations, medical centers, and patient groups.

"Tens of thousands of lives will be saved by providing America's seniors with fair and equitable access to the same lifesaving lung cancer screening that is now being offered to those with private insurance," said Laurie Fenton Ambrose, president and CEO of the Lung Cancer Alliance. "Now, we will focus our attention on making sure those who would benefit most from this screening actually get screened."

The US Preventive Services Task Force issued its final recommendation for lung cancer screening at the very end of 2013, which supports annual screening for adults between the ages of 55 to 80 years who have a 30 pack-year smoking history and who currently smoke or have quit within the last 15 years. Their recommendation fell in line with those issued by several other bodies, including the American Cancer Society, the American College of Chest Physicians, and the National Comprehensive Cancer Network, which, in November 2011, was the first to issue a guideline for lung cancer screening.

The CMS draft decision would extend coverage for CT scans to Medicare beneficiaries who fall into the guidelines recommended by the task force. Scans would be completely covered by Medicare with no cost to the beneficiary, and would apply to up to the age of 74.

Although there have been questions about the cost of adding a lung cancer screening program to Medicare, an analysis presented earlier this year found that it could result in the detection of approximately 54,900 more lung cancer cases during a 5-year period, with most at an early and more treatable stage. This would extrapolate to a cost increase of $9.3 billion, or an additional $3 per month increase in premiums for beneficiaries.

It is estimated that it would double the proportion of early-stage diagnoses from the current 15% to 33%, whereas lung cancers diagnosed at a distant stage would decrease from the current 57% to 40%.

The Affordable Care Act will require private insurers to cover lung cancer screening without cost-sharing beginning in 2015.

CMS is seeking comments on the proposed decision for a 30-day period, and is expected to issue a final decision in February 2015.

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