- CMS is proposing to lower the eligible age for smokers to begin annual lung cancer screenings to 50 from 55, in a reconsideration of its national coverage determination. The lung cancer screenings would use low-dose CT scans.
- The proposed NCD also decreases Medicare beneficiaries' eligible smoking history to 20 pack-years from 30 pack-years. A pack-year is equal to smoking one pack of 20 cigarettes per day for one year. Current smokers or those who have quit smoking within the last 15 years would be eligible.
- Needham analysts contend the new recommendation nearly doubles the eligible patient population for lung cancer screening tests. The analysts expect a larger pool of eligible patients to drive demand for diagnostic test makers Veracyte, Oncocyte and NeoGenomics as more screening and nodule detection takes place.
CMS initiated the NCD re-evaluation after the U.S. Preventive Services Task Force, an independent, volunteer panel of national experts in prevention and evidence-based medicine, in March issued a new recommendation statement on annual lung cancer screening for non-symptomatic smokers with low-dose CT scans.
The current NCD was published in February 2015 and followed an earlier recommendation from the U.S. Preventive Services Task Force.
Veracyte officials have said that 15 million people are eligible for screening under the latest USPSTF guidance, and only 1 million patients are being screened on an annual basis, Needham's analysts wrote in a note to clients last week after CMS released the proposed NCD.
In addition to the task force recommendation, CMS also received a request to reconsider the existing lung cancer screening NCD from groups including the GO2 Foundation for Lung Cancer, Society of Thoracic Surgeons, and American College of Radiology.
Lung cancer is the leading cause of cancer-related death in both men and women in the U.S. and the third most common form of cancer. The National Cancer Institute estimates the number of new cases at more than 235,000 this year, with cancer of the lung and bronchus expected to cause more than 130,000 deaths in 2021, exceeding the total number of estimated deaths from colon, breast and prostate cancer.
CMS noted that lung cancer has a generally poor prognosis, with a five-year relative survival rate of 22.1%. Less than 20% of patients are diagnosed with localized stage 1 cancer.
But if caught in its early stage, the disease has a better prognosis and is more likely to respond to treatment. Patients with localized disease have a 60% five-year survival rate, compared to 33% for those whose cancer has spread to the lymph nodes and 6% for those with distant pulmonary metastases.
"By leading to earlier detection and treatment, screening for lung cancer can give patients a greater chance for cure," CMS said in its proposed NCD.
The Needham analysts said they expect CMS to follow through on the proposal. "We view the proposed NCD as positive for detection of early-stage lung cancer and diagnostic tests associated with lung cancer," they wrote.
CMS is seeking public input for 30 days on the proposed NCD and said it will respond to comments in a final decision memorandum.