The lung cancer advocacy organizations that comprise the Lung Cancer Action
Network are concerned about the FDA’s proposed “Framework for Regulatory
Oversight of Laboratory Developed Tests (LDTs)” released in the 2014-10-03 Draft
Guidance. This framework could limit lung cancer patients’ access to molecular
testing essential for guiding treatment and identifying potentially life-saving
therapies. Read more…
News and Press
The lung cancer advocacy organizations that comprise the Lung Cancer Action
Radon is a cancer-causing, radioactive gas that occurs naturally from the decay of uranium which are found at different levels in rock and soil around the world. Radon can enter your home’s indoor air through the soil and the water, although, radon in water usually stems from well water or from a public water supply system that uses ground water.
Radon is the second leading cause of lung cancer, and the number one cause among non-smokers. The EPA (Environmental Protection Agency) estimates that approximately 21,000 lives are taken each year by radon induced lung cancer.
The good news is that at risk radon levels are easy to fix! The only way to know if you home is safe from radon is to test it. Even a neighbor’s test will not be a good indication of whether or not your home is safe from radon. According to the EPA, radon levels can vary from home to home. The only way to know your home is safe from radon is to test it.
For more information on radon, see the EPA’s City Guide on Radon and view and share our infographic below.
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The Centers for Medicare & Medicaid Services (CMS) proposes that the evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low dose computed tomography (LDCT), once per year, as an additional preventive service benefit under the Medicare program only if all of the following criteria are met:
Beneficiary eligibility criteria:
- Age 55-74 years;
- Asymptomatic (no signs or symptoms of lung disease);
- Tobacco smoking history of at least 30 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);
- Current smoker or one who has quit smoking within the last 15 years; and
- A written order for LDCT lung cancer screening that meets the following criteria:
- For the initial LDCT lung cancer screening service: the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit, furnished by a physician [as defined in Section 1861(r)(1) of the Social Security Act (the Act)] or qualified non-physician practitioner (physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5) of the Act).
- For subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit (for example: during the Medicare annual wellness visit, tobacco cessation counseling services, or evaluation and management visit) with a physician (as defined in Section 1861(r)(1) of the Act) or qualified non-physician practitioner (physician assistant, nurse practitioner, or clinical nurse specialist as defined in Section 1861(aa)(5) of the Act).
- A lung cancer screening counseling and shared decision making visit includes the following elements (and is appropriately documented in the beneficiary’s medical records):
- Determination of beneficiary eligibility including age, absence of signs or symptoms of lung disease, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting;
- Shared decision making, including the use of one or more decision aids, to include benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure;
- Counseling on the importance of adherence to annual LDCT lung cancer screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment;
- Counseling on the importance of maintaining cigarette smoking abstinence if former smoker, or smoking cessation if current smoker and, if appropriate, offering additional Medicare-covered tobacco cessation counseling services; and
- If appropriate, the furnishing of a written order for lung cancer screening with LDCT. Written orders for both initial and subsequent LDCT lung cancer screenings must contain the following information, which must also be documented in the beneficiaries’ medical records:
- Beneficiary date of birth,
- Actual pack-year smoking history (number);
- Current smoking status, and for former smokers, the number of years since quitting smoking;
- Statement that the beneficiary is asymptomatic; and
- NPI of the ordering practitioner.
Radiologist eligibility criteria:
- Current certification with the American Board of Radiology or equivalent organization;
- Documented training in diagnostic radiology and radiation safety;
- Involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years; and
- Documented participation in continuing medical education in accordance with current American College of Radiology standards.
Radiology imaging center eligibility criteria:
For purposes of Medicare coverage of lung cancer LDCT screening, an eligible LDCT screening facility is one that:
- Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;
- Must use LDCTs with an effective radiation dose less than 1.5 mSv; and
- Must collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed. The data collected and submitted to a CMS-approved national registry must include, at minimum, all of the following elements:
|Data Type||Minimum Required Data Elements|
|Radiologist (reading)||National Provider Identifier (NPI)|
|Ordering Practitioner||National Provider Identifier (NPI)|
|Demographics||Date of birth, gender, race/ethnicity.|
|Indication||Lung cancer LDCT screening – absence of signs or symptoms (y/n)|
|Smoking history||Current status (current, former, never),
If former smoker, years since quitting,
Pack-years as reported by the ordering practitioner.
|CT scanner||Manufacturer, Model.|
|Effective radiation dose||CT dose index, tube current-time, tube voltage, scanning time, scanning volume, pitch, slice thickness (collimation).|
|Screening exam results||Baseline or repeat screen;
Clinically significant non-lung cancer findings (y/n), if yes, list;
Nodule (y/n), if yes: number, type (calcified or non-calcified; solid or semi-solid), size and location of each nodule.
|Diagnostic follow-up of abnormal findings within 1 year||Low dose chest CT,
Diagnostic chest CT,
Resection (with dates),
Other (please specify).
|Lung cancer incidence within 1 year||Incident cancers,
Date of diagnosis,
Period of follow-up for incidence.
|Health outcomes||All cause mortality,
Lung cancer mortality,
Death within 60 days after most invasive diagnostic procedure.
For purposes of Medicare coverage of LDCT lung cancer screening, national registries interested in seeking CMS approval must send a request either electronically or hard copy to CMS (Note: It is not necessary to submit both electronic and hard copies of requests).
Please send electronic requests via email to firstname.lastname@example.org. Hard copy requests may be sent to the following address:
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality
Director, Coverage and Analysis Group
ATTN: Lung Cancer LDCT Screening
Mail Stop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244
CMS is seeking comments on the proposed decision. We will respond to public comments in a final decision memorandum, as required by §1862(l)(3) of the Social Security Act.
This article was originally published on cms.gov and can be found here. http://go.cms.gov/
NEW YORK—(October 21, 2014) In a recently launched online social media campaign, LungCAN members and their constituents are fighting back with Tweets, Facebook posts, and social ads with a message that is loud and clear: lung cancer screening saves lives and it disproportionately affects seniors, which is why Medicare should include lung cancer screening as a covered Medicare benefit.
LungCAN’s Medicare campaign, blended with the recent online #WhipLungCancer campaign, is part of a three-pronged campaign approach orchestrated by Social Strand Media, a boutique San Francisco based social media agency. The multi-part campaign addresses urging Medicare to cover lung cancer screening, participation in Genentech’s Lung Cancer Project to address stigma and raise awareness of low treatment rates for lung cancer patients, and testing your home for radon, the second leading cause of lung cancer, during the holidays. Phase one of the campaign commenced in October and phase two and three will run through November and December. Click to read full press release.
Get involved with lung cancer advocacy by taking the #WhipLungCancer Challenge, or by urging Congress to make lung cancer screening a covered Medicare benefit. You can learn more about both of these initiatives under the ‘Get Involved’ tab in the top menu navigation or by clicking on these links: Urge Medicare and #WhipLungCancer
The Center for Medicare and Medicaid Services (CMS) is now considering whether
Medicare should cover lung cancer screening for seniors at high risk for the disease.
Astonishingly, rejecting scientific evidence that lung cancer screening saves lives, the
Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)
recommended against Medicare covering the cost of this procedure. The panel, however,
did not include members who specialize in lung cancer. Read our letter to view LungCAN’s position letter on Medicare coverage for lung cancer screening.
Experts Predict Tens of Thousands Lives Saved
NEW YORK—(AUGUST 15, 201 3) Lung Cancer Action Network (LungCAN) members unanimously endorse lung cancer screening recommendations released in draft form recently by the U.S. Preventive Services Task Force.
“Tens of thousands of lives will be saved,” says Lung Cancer Alliance President and CEO Laurie Fenton-Ambrose. “Screening those at high risk now will dramatically make a difference and will open the door to much faster advances in research on all stages of lung cancer. This is a game changer.”
The Task Force recommends people between ages 55 and 79 with a minimum smoking history of 30 pack years get an annual low-dose CT scan. The recommendation applies to current smokers and former smokers who quit within the past 15 years. Pack years are calculated by multiplying the average number of packs smoked a day by the number of years smoked. One pack a day for 30 years or two packs a day for 15 years equal 30 pack years.
Lung cancer screening has the potential to be the most effective cancer screening, in terms of lives saved per screening. For example, it takes approximately 900 mammograms of women between ages 50 to 65 to prevent one breast cancer death. That number is significantly higher in younger women. To prevent one cancer death in women ages 40-49, it would take approximately 1,900 mammograms. And for colorectal cancer, the estimate is that one death is prevented for every 500 people screened by colonoscopy. Evidence shows that to prevent one lung cancer death, it takes approximately 320 high-risk persons screened by low-dose CT scan, according to the Task Force.
LungCAN credits the contributions of many to bring this undertaking to fruition, including an army of researchers, advocates, volunteers, patients and many others, in addition to Task Force members. Lung cancer advocates have helped usher in and witnessed major advances in recent months, including the passing of the Recalcitrant Cancer Research Act and the National Lung Screening Trial results which contributed significantly to the Task Force’s recommendation.
While experts predict lung cancer screening may save 20,000 lives a year, many more lives remain at stake. LungCAN member organizations will not rest on these laurels. Lung cancer remains the number one cancer killer, claiming more lives than breast, colorectal, prostate and pancreatic cancers combined. Early detection for those at high risk is a step in the right direction.
“This is a vital step in saving lives from lung cancer for the thousands of people who fit the high-risk profile,” said Andrea Ferris, President and Chairman of LUNGevity Foundation. “However, tens of thousands of people will be diagnosed with lung cancer this year who do not fit into these parameters. We remain committed to finding a non-invasive test so that lung cancer can ultimately be found earlier in the full population affected.”
The recommendation, which is in draft form, is open for public comments through Aug. 26, 2013. The final version will incorporate revisions based on comments received. To comment on the recommendation, go to: www.uspreventiveservicestaskforce.org/draftrec.htm. When finalized, under the Affordable Care Act, health insurance will cover the cost screening with no co pays for those identified as high risk.
Even though the radiation exposure is fairly low, lung cancer screening is not recommended for everyone because the cumulative exposure to radiation over the course of a screening program cannot be considered harmless, according to the Task Force. For those at high risk, however, the benefits far outweigh the risk.
The Lung Cancer Action Network is a collective group of lung cancer organizations united to serve as a vehicle, filter, incubator for the exchange of ideas and information. LungCAN facilitates and enhances opportunities for collaboration with the focus on lung cancer. For more information about LungCAN, visit LungCAN.org.