Recent Events Clarify the Likely Future of Lung Cancer Screening in the United States

2015-01-06
 

LDCT Lung Cancer Screening This is an update to my earlier post discussing how the early detection of lung cancer via low-dose computed tomography (LDCT) has been shown to be effective enough in certain populations to warrant a screening program, but that coverage of such a program under Medicare was the subject of some debate.

CMS (Preliminary) Decision

The big news, of course, is that in mid-November CMS made a proposed Decision Memo indicating that Medicare would, indeed, cover lung cancer screening.

The final ruling from CMS is expected in February 2015 and could include some further refinements to the program currently outlined (more on that below).

The RSNA Buzz

The timing of the CMS announcement meant that LDCT lung cancer screening was a hot topic at the annual meeting of the Radiological Society of North America (RSNA) which began on November 30th in Chicago. Many of the sessions originally intended to discuss lung cancer research and clinical practice were diverted into discussing the myriad details of the proposed CMS program.

Let’s walk through the details of CMS’ proposed program for coverage…

Who Would Be Covered?

The coverage will apply to a fairly large subset of Medicare patients but is not available to all.

Specifically, it will cover Medicare patients between 55-74 years of age, who are asymptomatic for lung cancer and who have a 30 pack year history of smoking. The phrase “30 pack year history” means someone who smoked 20 or more cigarettes a day, every day, for 30 years.

Additionally, the Medicare patient must have smoked in the past 15 years. Those who quit smoking more than 15 years ago and stayed smoke-free since are not covered.

Even under these criteria an estimated 7-10 million Americans are thus likely to find themselves newly covered by this screening program.

Which Institutions?

Under the CMS’ proposed rules, in order to perform LDCT lung cancer screening, an institution must have “participated in past lung cancer screening trials, such as the National Lung Screening Trial” (NLST), or be “an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening.”

One assumes that the American College of Radiology (ACR) will be involved in granting the “accredited” status above.  They certainly think so (see end of this article). But for now, unless the institution was already in a past lung cancer screening trial, it will have to seek accreditation when this process is defined.

In addition, each institution will need CT scanners able to perform the studies with a dose of less than 1.5 mSv.

Finally, the institutions will need to submit data to a CMS-approved national registry. Currently there are 13 distinct data elements required for each submission.

Which Radiologists?

Radiologist eligibility to interpret the studies is based on the factors that one would expect:

  • Current certification with the American Board of Radiology (ABR) 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 ACR standards.

What Are the Other Requirements?

In order to address concerns that patients are given the opportunity to make an informed decision, CMS’ proposed program introduces the concept of a “lung cancer screening counseling and shared decision making visit.” In addition to establishing the patient’s smoking history (and thus basic eligibility for screening), the session would be used to educate the patient on the risk / benefit trade off of the screening program. If the patient is still smoking, this would be used as an opportunity to encourage quitting.

This interview would need to be documented by the healthcare provider for the patient to enter the screening program, and this documentation maintained for as long as screening continues.

ACR, LCA and STS Request Modifications

As you can see from the information above, the program contains a fair number of restrictions and requirements. Ostensibly, these controls are to ensure high-quality exams and minimize potential patient harm, while ensuring the broadest population benefit possible.

The American College of Radiology (ACR), while it welcomed the screening coverage in general, felt that some of the proposed requirements were inappropriate. This point of view was shared by the Lung Cancer Alliance (LCA) and the Society of Thoracic Surgeons (STS). The three bodies outlined their concerns in a joint comment letter to the CMS.

In addition to putting forward the ACR as a logical accrediting body, the letter contained seven comments from the societies, but the key ones appeared to be:

  • That CMS deviated from the United States Preventive Services Task Force’s (USPSTF) benefit modeling when it chose to exclude patients aged 75-80 from screening coverage, and should reconsider this cut-off;
  • That patients who quit smoking more than 15 years ago be declared eligible (since there is no strong evidence that risk falls off on this threshold and the rule could inadvertently encourage smoking);
  • The wording related to the “asymptomatic” patient requirement could lead to ineligibility of many patients who are asymptomatic for lung cancer but not other lung diseases, and therefore this wording should be clarified;
  • The “advanced diagnostic imaging center with training and experience in LDCT lung cancer screening” requirement language be simplified to just “provider of chest CT with training in LDCT lung cancer screening;” and
  • Board eligibility of the radiologist should be accepted, not just board certification.

It will be interesting to see how CMS responds to these comments while formulating the final rules.

Interested in reading more on the topic? See my earlier post about the Lung Cancer Screening Debate.

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