Tag Archives: lung cancer screening

Comments on CMS’s Proposed Decision Memo on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

December 17, 2021


We agree that former smokers would benefit from a higher rate of low dose computed tomography (LDCT) lung cancer screening. However, we are concerned with several major aspects of the Proposed Decision Memo’s discussion of Counseling and Shared Decision-Making.

  1. We urge CMS to amend language in the final draft of the Decision Memo to more accurately reflect the science-based evidence. The proposed memo currently reads that “Professional societies and provider groups have noted that providers have gained considerable experience and expertise and believe flexibility will reduce burden.” However, there is no evidence that providers have become better at counseling and shared decision-making regarding LDCT; on the contrary, there is evidence that there is already too much flexibility in how these discussions are framed. For example, research has found that shared decision-making conversations regarding LDCT focus on the advantages and rarely discuss the potential harms.[1] Healthcare providers spent less than a minute explaining the procedure and there was no evidence that decision aids were used. Patients deserve to make informed choices, and this is not possible under the current norms, which are too flexible. Rather than increase flexibility, CMS should provide explicit guidance for shared decision-making discussions on LDCT, such as requiring a checklist of key benefits and risks for the procedure that patients must sign after having read and discussed each point with their healthcare provider. For example, a decision-making tool could include a checklist that explains each benefit and risk in non-technical language, where the patient must initial each section to indicate that they read it, and then the physician must sign it to indicate the conversation took place, in the presence of the patient. In addition, any decision-making tool should highlight beneficiary eligibility criteria to ensure that patients who do not meet these criteria are aware that they are more likely to be harmed by LDCT screening.

 

  1. We urge that CMS maintain the requirement that shared decision-making conversations include a patient’s healthcare provider. Although research indicates that the decision-making conversations with physicians and non-physician practitioners are often inadequate, we believe the solution is to improve training for those conversations, rather than allowing health educators and others who are not healthcare experts to provide counseling and shared decision-making without the inclusion of healthcare professionals. Shared decisions regarding medical options should be made between a patient and a healthcare provider with whom they have an established relationship, which is generally their primary care physician. That is important because if there are any abnormal findings from the LDCT, it is the healthcare provider that the patient will need to follow-up with, not an educator. Shared decision making also provides an important opportunity to discuss smoking cessation options, which primary care physicians are best equipped to do. In summary, when patients engage in shared decision-making with their healthcare provider, that aids in informed decision-making while also helping ensure continuity of care. While health educators and others who are specifically trained to discuss the risks and benefits of LDCT can be an important addition to those doctor-patient conversations, spending more time with patients than physicians do and ensuring that patients clearly understand their options, they should not replace doctor-patient shared decision-making.

 

  1. We also urge that CMS reconsider its proposal to remove the specifications for the components of the shared decision-making tools. The agency justifies this change by stating that “the tools and guidance has matured since the early inception of shared decision-making.” We are not aware of evidence that the tools and guidance have matured, and ask CMS to provide guidance regarding decision-making tools that are based on peer-reviewed research-based articles.

 

  1. CMS also proposes removing the LDCT lung cancer screening registry requirement. We disagree with that proposal, since the ongoing revisions to guidance regarding LDCT screening can best be evaluated using a required registry.

As a final point, we question the assumptions that patients’ current low level of screening is a function of lack of flexibility in shared decision-making and of the criteria for eligibility. We believe it more likely that the major causes are:

  • Former smokers are aware that their smoking put them at risk of lung cancer and they are reluctant to get tested to find out they could have a fatal disease that they were warned about for years.
  • Former smokers who have friends or relatives that died of lung cancer are especially afraid of a diagnosis because they have seen the ravages of lung cancer.
  • Discussions about LDCT that extol the benefits and ignore the risks (which research indicates are typical of these conversations) are likely to be perceived as a sales pitch by skeptical patients. A more balanced conversation about what the procedure is like, the potential risks of screening, and what research says about the benefits is likely to be more effective.

NCHR firmly believes that patients deserve to make informed choices and need access to counseling and evidence-based shared decision-making tools in order to do so. For the reasons outlined above, we urge CMS to reconsider the proposed changes, to better ensure that patients receive accurate, balanced, unbiased information on whether or not they would benefit from LDCT screening.

References

  1. Brenner, A. T., Malo, T. L., Margolis, M., Lafata, J. E., James, S., Vu, M. B., & Reuland, D. S. (2018). Evaluating shared decision making for lung cancer screening. JAMA internal medicine178(10), 1311-1316.

Fast Facts: Should you get screened for Lung Cancer?

For our in-depth article on lung cancer screening, click here.

By Tiffanie L. Hammond, Amrita Ford, MA, and Anna E. Mazzucco, Ph.D.
January 2014

Lung cancer is the second most commonly diagnosed cancer in both men and women in the U.S., but it is the #1 cancer killer. In 2013, approximately 228,000 men and women were diagnosed with lung cancer and close to 160,000 men and women died from it.  One of the reasons lung cancer is so deadly is that symptoms usually appear during the later stages, when treatment is least effective. General symptoms include:

  • a persistent cough that may worsen over time, including coughing up blood
  • breathing trouble, such as shortness of breath
  • chest pain
  • raspy or hoarse voice
  • frequent lung infections, such as pneumonia
  • extreme and constant fatigue
  • unintentional weight loss

If you experience any of these symptoms, call your doctor.

The purpose of screening for cancer is to diagnose it before symptoms appear, when it can be treated more effectively.  In July 2013, the U.S. Preventative Task Force (USPTF) released a draft recommendation for screening those at highest risk for lung cancer using low-dose computerized tomography scans (low-dose CT), which was finalized in December.  CT scans provide very detailed pictures of your lungs, much more detailed than x-rays. Researchers found that using low-dose CT scans could reduce lung cancer deaths by 20%.  People who should be screened include:

  • Current smokers between 55 and 79 years-old who have a smoking history of “30 pack-years” (20 cigarettes a day for 30 years, 40 cigarettes a day for 15 years, and so on)
  • Former smokers (who quit in the last 15 years) who are between 55 and 79 years-old and had a “30 pack-year history of smoking.

 

To calculate your pack years, visit http://smokingpackyears.com/.

This draft recommendation was finalized at the end of 2013. Already insurance companies are covering the cost of the screening, as long as the person meets the screening criteria.

As with any screening, there are risks as well as benefits. Some of the risks include radiation exposure and a high rate of false positive test results—test results indicating that a person has something worrisome in their lung that turns out to be nothing serious. Some experts call this “over-diagnosis.” In the largest study done so far, about 1 in 4 people had a false positive finding if they had three years of annual screening.  A false positive finding can lead to invasive procedures, such as needle biopsies, which can puncture the lung and cause it to collapse.  Although very serious complications are rare (less than one in 1,000), they can occur.  Even low-dose CT scans of the lungs expose patients to much more radiation than a chest x-ray. There is almost no short-term risk from this radiation, but having many x-rays or several CT scans can increase a person’s risk of cancer. A 2012 law increased funding for lung cancer research to promote better detection and treatments in the future.   Research is also being done to find ways to reduce the number of false-positives and unnecessary follow-up procedures.

For more detailed information about lung cancer risk factors, symptoms, detection, and CT screening, including the risks of radiation and over-diagnosis, see this article.