The topic for #LCSM Chat on Thursday, December 4, 2014 at 8PM ET will be, “CMS lung cancer screening rules: overboard, or on the mark?”  Our moderator Janet Freeman-Daily (@JFreemanDaily) will lead our discussion using the topics below. You can learn more about #LCSM Chat and how to join it here.

• T1: Do you agree with patient characteristics defined in CMS proposed lung cancer screening coverage?
• T2: Do you agree there is potential harm in lung cancer screening at centers that don’t have counseling or extensive experience?
• T3: Will CMS limitations channel patients to most qualified centers, or instead keep patients from lung cancer screening?
• T4: Are limitations on lung cancer screening fair & appropriate compared to screening for other cancers?

BACKGROUND

On November 10, the US Centers for Medicare and Medicaid Services (CMS) issued a proposed decision to cover low dose chest computerized tomography (LDCT) lung cancer screening for high-risk patients.  CMS is accepting comments on this proposed decision for 30 days, and will issue its final decision in February 2015.  Private health insurance policies that fall under the Affordable Care Act (ACA) are required by law to cover lung cancer screening with LDCT as of January 1, 2015.

The lung cancer community had worked towards this outcome for many months.  Over 70 professional societies, medical centers and universities wrote a joint letter to CMS in support of lung cancer screening; in it, they cited considerable medical evidence, and outlined the conditions under which screening should be implemented.  Eighteen lung cancer advocacy organizations wrote a joint letter supporting the Joint Societies letter.  A team led by the American College of Chest Physicians presented a policy to CMS on “Components Necessary for High Quality Lung Cancer Screening.”  The collaborative effort behind this decision was huge, and the entire community celebrated the proposed CMS decision.

According to Dr. Gerard A. Silvestri, President-Designate of the American College of Chest Physicians, lung cancer screening will save one life for every 256 people screened.  That’s similar to the stats for mammography.  He believes the greatest challenge in making lung cancer screening widely available is having programs available to manage nodules detected during screening.

Lung cancer screening is not without risk:  it’s likely to detect one or more nodules that may or may not be cancer.  If a nodule is found, the doctor may recommend follow-up imaging–doctors can use subsequent CT scans to determine whether a nodule is growing.  However, assessment of a nodule might require an invasive intervention like a biopsy, which might discover the nodule was not cancer.  To minimize harm to patients, only patients at high risk for lung cancer should be screened.  For now, that means never smokers are not eligible for screening because they are much more likely to have benign nodules than cancer.

Given recent controversy regarding screening criteria for other cancers, a key component of the CMS decision is to ensure the benefits of lung cancer screening outweigh the risks.  To reduce the risk, the proposed CMS decision sets specific restrictions on LDCT coverage:

• Screening must be done at accredited facilities;
• Scans must be interpreted by radiologists who meet certain requirements;
• Patients must be: asymptomatic (have no symptoms of lung cancer), between the ages of 55-74, current heavy smokers or former heavy smokers who quit within the past 15 years, and healthy enough for surgery;
• Patient must participate in counseling and shared decision making about the benefits and risks of screening, as well as smoking cessation (if appropriate); and
• Screening results must be entered into a central registry.

Depending on one’s perspective, the proposed CMS decision can be seen as providing safeguards necessary to minimize the risks of lung cancer screening, OR as creating barriers that might keep high-risk patients from getting screened.  Some reviewers (e.g., Otis Brawley of the American Cancer Society) think CMS struck just the right balance between benefits and risks.  Others in the lung cancer community have raised concerns that the proposed decision is too restrictive.

Examples of concerns that have been raised about the decision are:

• The CMS proposed decision sets 74 as the upper age limit for screening. Yet a recently-published study of a validated lung cancer risk model found the highest lung cancer risks were in people aged 65-80. NCI statistics say the 75-84 age group represents 27.9% of diagnosed lung cancer cases. Should the age limit for screening be higher, perhaps age 80?
• The symptoms of lung cancer can be subtle (e.g., tiredness or a cough) and similar to symptoms of other conditions such as COPD or medication side effects. What does an “asymptomatic” patient look like in this context?
• Requiring screening centers to be accredited reduces the risk of mistakenly labeling a benign nodule as cancer. However, the cost and effort of obtaining accreditation may limit the availability of affordable lung cancer screening to the CMS population. How can we make quality lung cancer screening widely available?

Thanks to Andrea Borondy Kitts and Dr. Jack West for their contributions to this blog post.

REFERENCES

1. Centers for Medicare and Medicaid Services. Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). Accessed 12/2/2014 at http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=274
2. Joint Societies. (26-Sep-2014). Letter to CMS. Accessed 12/4/2014 at http://www.acr.org/~/media/ACR/Documents/PDF/Advocacy/Fed%20Relations/LCS%20Stakeholder%20Letter%2009%2026%2014_FINAL.PDF
3. Lung Cancer Alliance. (8-Oct-2014). Letter to CMS. Accessed 12/4/2014 at http://www.lungcanceralliance.org/Screening/CMS%20/CMS-Letter-FINAL%20Lung%20Cancer%20Patient%20Advocacy%20Organizations.pdf
4. American College of Chest Physicians. (30-Oct-2014). CHEST lung cancer experts present policy statement to CMS Committee on Coverage. CHEST website. Accessed 12/4/2014 at http://www.chestnet.org/News/Press-Releases/2014/10/CHEST-lung-cancer-experts-present-policy-statement-to-CMS-Committee-on-Coverage
5. Brawley, O. (13-Nov-2014). CMS Got it Right in Lung Cancer Screening Coverage Decision. The Cancer Letter. Accessed 12/3/2014 at http://cancerletter.com/articles/20141114_2
6. Tammemägi MC, Church TR, Hocking WG, Silvestri GA, et al. (2-Dec-2014.) Evaluation of the Lung Cancer Risks at Which to Screen Ever- and Never-Smokers: Screening Rules Applied to the PLCO and NLST Cohorts. PLOS Medicine. DOI: 10.1371/journal.pmed.1001764 Accessed 12/4/2014 at http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001764
7. National Cancer Institute. SEER Stat Fact Sheets: Lung and Bronchus Cancer. (No Date). Accessed 3-Dec-2014 at http://seer.cancer.gov/statfacts/html/lungb.html