The Centers for Medicare and Medicaid Services (CMS) recently announced that annual lung cancer screening with low-dose computed tomography (CT) would be reimbursed for those who fit specific criteria. This decision occurred despite a CMS advisory panel warning that there is not enough evidence to annually screen those at high risk for lung cancer. To discuss this decision, we are speaking with David Tom Cooke, MD, who is the co-head of the lung cancer screening program and associate professor of clinical surgery at the University of California Davis Comprehensive Cancer Center.
—Interviewed by Anna Azvolinsky
Cancer Network: Dr. Cooke, can you tell us about the individuals who are now eligible for annual lung cancer screening?
Dr. Cooke: Thank you for inviting me to talk about this important subject. The individuals who are eligible for lung cancer screening with low-dose CT scans are those described as high-risk patients—those who are current or former smokers age 55 to 77 or to age 80 depending on your insurance. They must have smoked the equivalent of one pack per day for at least 30 years, and if they are a former smoker they should have quit within the previous 15 years. The patient must have no current respiratory symptoms at the time of the exam.
Cancer Network: How did CMS make this decision? In other words, what was the evidence in favor of screening?
Dr. Cooke: CMS based its decision on the National Lung Screening Trial, or NLST. This was a multi-institution clinical trial that randomized high-risk patients to annual screening with low-dose CT or plain chest x-ray. They also based their decision on data analysis and recommendations from the US Preventive Services Task Force (USPSTF). The data from NLST clearly showed that screening with low-dose CT scans reduces the risk of dying from lung cancer in heavy smokers by 20% compared to screening with simple chest x-rays. Based on this, the USPSTF released a Grade B recommendation for annual low-dose CT scans to screen individuals who are at high risk for lung cancer.
Cancer Network: Last year, an independent advisory committee had recommended against screening. What was that recommendation based on?
Dr. Cooke: That ruling came from an advisory committee called MEDCAC or the Medicare Evidence Development & Coverage Advisory Committee. Their review was a “quote unquote” low confidence recommendation and this undoubtedly influenced the final decision for Medicare coverage. They based their decision on a high false-positive rate and what they described as lack of evidence based on oversight, meaning that if there is any kind of oversight to limit the proliferation of lung cancer screening in non–high-risk individuals. They were worried about the proliferation of suboptimal screening programs and felt that more randomized clinical trials were needed. Many of those points were valid. With regards to more randomized clinical trials, there is only one other randomized clinical trial in the works and that is in Europe, in a potentially different patient population. NLST was a large, very expensive, randomized trial that showed significant results. As a result of MEDCAC’s recommendation, CMS required adherence to strict stipulations in order for a screening center to be reimbursed. This includes requirement for a shared decision-making counseling session; accreditation of technology and facilities; smoking cessation counseling; and submission of data variables, including outcomes, to a CMS-approved registry.
Cancer Network: Is there still debate on whether there should be systematic lung cancer screening? What are the benefits and potential caveats to screening?
Dr. Cooke: The debate centers on cost, risk to the patient, who is defined as high-risk, and the length of time we screen patients. The USPSTF also recommended that screening should discontinue once a person has stopped smoking for 15 or more years or has developed a medical condition that would preclude curative surgery if a lung cancer was to be found. There is a current discrepancy on who gets coverage. If Medicare or Medicaid is your sole insurance, then you can be covered for lung cancer screening up to age 77. If you have private insurance, then up to age 80. The reason for this is that whatever the USPSTF gives as a Grade B recommendation or higher must be covered by private insurance according to the Affordable Care Act. Since USPSTF recommended lung cancer screening up to age 80, that means if you have private insurance you can get lung cancer screening up to age 80. CMS only approved screening up to age 77. It is unclear why this discrepancy exists. The benefit of lung cancer screening is the reported 20% reduction in cancer mortality, as well as a 7% reduction in overall mortality.
Lung cancer screening also resulted in a stage shift. Currently, 75% of patients diagnosed with lung cancer are diagnosed at late stage, stage III or IV, where the chances of cure are poor. In the NLST, 75% of patients diagnosed with lung cancer were diagnosed at either stage I or stage II, where the odds of cure are high. In regards to risk to patients, there is a high false-positive rate—there’s a 20% to 25% chance that you will end up with a false positive. There is a false discovery rate—there’s a 96% chance that if your screen is positive, you don’t have lung cancer. And there is a false-positive biopsy rate, so 0.4% to 2.4% of patients screened ended up with unnecessary invasive procedures. These risks need to be discussed with the patient as part of a shared decision counseling session.
Cancer Network: Lastly, you mentioned cost. How much does CT screening cost and how is it reimbursed?
Dr. Cooke: Currently there should be no cost to the patient. CMS stated that there will be coverage for Medicare and Medicaid beneficiaries if the provider follows the stipulations that are outlined by CMS. In addition, as part of the Affordable Care Act, all Grade B recommendations or higher by the USPSTF are covered starting January 1st of this year by private insurers as part of an essential health benefit. All imaging studies have a cost to the insurance payer and that is determined in part by the insurance payer and the providing facility. If you look at the overall cost to healthcare in general, a study by Pyenson et al in 2012 projected that lung cancer screening costs per lives saved would be below $19,000, which would be below cervical, colorectal, and breast cancer in 2012 dollars. A more recent modeling analysis released at the 2014 American Society of Clinical Oncology meeting projected lung cancer screening will result in $3 more per month in Medicare premiums compared to $2.50 for mammography in most private insurance plans.
Cancer Network: Thank you so much for joining us today, Dr. Cooke.
Dr. Cooke: Thank you very much.