Call for Sites Currently Doing LDCT Lung Cancer Screening to Comment on CMS National Coverage Analysis
Good news. The Centers for Medicare and Medicaid Services (CMS) have started their review of lung cancer screening with Low Dose Computed Tomography (LDCT). This is the initial step in providing reimbursement for screening to those in the high risk population.
CMS is actively seeking feedback from medical professionals who are currently performing lung cancer screening with LDCT. The comment period closes March 12, 2014.
If you, or your organization, are already offering lung cancer screening with LDCT, your comments will be especially valuable in providing credible evidence of the feasibility of implementing and operating a responsible screening program.
Please provide the following information in your comments.
Tell CMS which patients at high risk for lung cancer should receive LDCT coverage.
We believe the screening population should include risk groups identified both by the USPSTF and the National Comprehensive Cancer Network (NCCN) guidelines. The USPSTF recommends screening current or former smokers 55 t0 80 years old with 30 or more pack-years of smoking history, with former smokers limited to those who quit within the last 15 years. The NCCN guidelines add a “risk group 2” to this recommended screening population. The NCCN risk group 2 includes those 50 and older with a 20 or more pack year smoking history and an additional risk factor such as a personal cancer history; a family lung cancer history; COPD/Pulmonary Fibrosis; or carcinogen exposure e.g. radon, asbestos. The additional risk factors acknowledged by the NCCN guidelines are known to significantly increase the risk of developing lung cancer.
Tell CMS lung cancer screening should be continued for former heavy smokers even after they reach the 15 year quit window.
The USPSTF final recommendation is for lung cancer screening to be discontinued once a former smoker reaches the 15 year quit window. Once a person reaches a 30 pack year smoking history (or 20 pack years with an additional risk factor) lung cancer mortality is not reduced for former smokers diagnosed with lung cancers regardless of the time since stopping smoking (Peto, J. That lung cancer incidence falls in ex-smokers: misconceptions 2. British Journal of Cancer 2011; 104:389 Retrieved from (http://www.nature.com/bjc/journal/v104/n3/full/6606080a.html)
- Tell CMS about your lung cancer screening process and experience
- Demographic information about your site
- Year started screening and number of patients screened
- The patient population being screened (e.g. NLST, NCCN, USPSTF)
- Duration and frequency of lung cancer screening
- Process for patient referral to the program
- Process for discussing the benefits and concerns of lung cancer screening with the patient
- Integration of a smoking cessation program into the screening process
- Reporting system for results
- Process for multidisciplinary medical team review of LDCT scans that have suspicious findings
- Process and guidelines for follow-up on LDCT scan pulmonary nodule findings
- Process for tracking patients to follow-up on positive findings
- Process to track patient lung cancer stage at diagnosis, biopsy proven false positives and any adverse patient effects
More details are included at the end of this post.
Here is the link to the National Coverage Analysis (NCA) Tracking Sheet for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N). Click on the “Comment” bar on the right side of the page underneath the title to provide your comment.
Thank you for taking the time to provide your experience and comments to the CMS. Lung cancer is the leading cause of cancer deaths in the US and worldwide for both men and women. With the advent of LDCT lung cancer screening we have the opportunity to save lives and move the needle on lung cancer survivability.
More Detailed Information
Here is a copy and paste of the information CMS is looking for from the comments:
“CMS has accepted two formal complete requests to initiate a NCA on Lung Cancer Screening with Low Dose Computed Tomography (LDCT), which is recommended with a grade B by the USPSTF for certain persons at high risk for lung cancer based on age and smoking history. The scope of our review is limited to LDCT Screening for lung cancer. We are particularly interested in evidence to inform the identification of patients eligible for screening; the appropriate frequency and duration of screening; facility and provider characteristics that predict benefit or harm; precise criteria for test positivity and the impact of false positive results and followup tests or treatments. We are also soliciting input on the influence of these factors on patient education and informed consent in Medicare beneficiaries including the elderly and younger disabled populations and persons receiving dialysis treatment for end stage renal disease; and on the integration of smoking cessation interventions for current smokers.”
Proposed Information to include in your comments:
1. Demographic Information about your site
Type of site; community cancer center, major urban cancer center, community imaging center, neighborhood imaging center , other
Year site started clinical lung cancer screening program
2. Information about your screening program
Number of patients screened to date
Patient population you are screening
- NLST (=NCCN group 1 high risk patients) – Group 1: 55 to 74; 30 pack yr smoking history; current smoker or quit within last 15 yrs.
- USPSTF final recommendation based population – 55 to 80; 30 pack yr smoking history; current smoker or quit within last 15 yrs; stop screening after 15 yr quit time reached
- NCCN Group 1 and 2 high risk patients Group 1: 55 to 74; 30 pack yr smoking history; current smoker or quit within last 15 yrs. Group 2: 50+; 20 pack yr smoking history; additional risk factor – personal cancer history; family lung cancer history; COPD/Pulmonary Fibrosis; Carcinogen exposure e.g. radon, asbestos
Duration and frequency of your lung cancer screening program; for example
- NLST – 3 screens; 1 prevalence and 2 annual incidence
- NCCN – annual screening until age 74
- USPSTF final recommendation – annual screening until age 80 or until 15 years quit smoking for former smokers
- Other ______________________
Describe your smoking cessation program; include all that apply, for example
- Continuum of care; smokers followed during lung cancer screening and follow-up actions
- Required referral to smoking cessation counselor
- Required referral to lung cancer navigator
- Referred for discussion with primary care physician
- Required to enter smoking cessation program to undergo screening
- Other __________________________________
Describe the process and guidelines you use to follow-up on LDCT scan pulmonary nodule findings; for example
- Fleishner criteria
- Other ___________________________
Describe your reporting system ; for example
- LungRADS system
- Other ___________________________________________
Describe how patients are referred to the program; include all that apply, for example
- Through a Primary Care Physician referral
- Directly through the screening center
- Self- Referral
- Through other medical specialist e.g. Pulmonologist or Cardiologist
- Other ____________________________
Describe how the benefits and concerns of lung cancer screening are discussed with the patient; include all that apply, for example
- Discussion with the Primary Care Physician
- Discussion with the screening center program navigator
- Discussion with specialist e.g. Pulmonologist or Cardiologist
- Formal Informed Consent briefing and documents
- FAQ’s or other patient education documents
- Other ___________________________________________________
Describe your multidisciplinary medical team review process of the LDCT scans that have suspicious findings to discuss and recommend follow-up
Describe how you track patients to follow-up on positive findings
Describe how you keep track of patient lung cancer stage at diagnosis, biopsy proven false positives and any adverse patient effects
Describe data tracked for follow-up results for pulmonary nodules detected via LDCT; include all that apply, for example
- number of screened patients who had pulmonary nodules
- biopsy results (including proven false positives)
- number and types of follow-up procedures on patients with pulmonary nodules (especially biopsies vs. watchful waiting)
- number and lung cancer diagnoses with staging
- any adverse effects experienced by patients due to LDCT
3. Your recommendation on CMS coverage for LDCT lung cancer screening and the specifics of which patient population to screen and the frequency and duration of screening; Include any additional recommendations you have on screening and follow-up protocols.
This post was written in collaboration with Andrea Borondy Kitts (@fundlungcancer)
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