The USPSTF on January 3 issued a draft research plan for colorectal cancer screening. The plan consists of a proposed analytic framework, key questions, study approach, and decision model designed to guide the USPSTF's review of colorectal cancer screening research as it updates its recommendations for the exam. The task force typically holds reviews in five-year intervals, but it has accelerated the release of the latest research plan by more than two years.
Dr. Judy Yee from Albert Einstein College of Medicine and Montefiore Medical Center.
This off-cycle proposal was likely initiated by a request from the review team of the U.S. National Colorectal Cancer Roundtable (NCCRT) in light of recent updates to the American Cancer Society (ACS) guideline, which recommends lowering the screening age for colorectal cancer to 45 years, according to Dr. Judy Yee. Yee currently serves as chair of radiology at the Albert Einstein College of Medicine in New York City and as chair of the American College of Radiology (ACR) Colon Cancer Committee.
Even though the USPSTF gave CTC the green light in its previous review, the U.S. Centers for Medicare and Medicaid Services (CMS) continues to withhold payment for the exam -- something that Yee hopes will change with the current review.
"My hope is that the USPSTF and, ultimately, the CMS come to understand that CTC has been received by many patients as a positive addition, and that it has brought in patients who otherwise might not have undergone screening," Yee told AuntMinnie.com. "The test allows us to provide to seniors what we currently are capable of providing to the community at large."
New draft research plan
In its previous 2016 guidance on colorectal cancer screening, the USPSTF gave an "A" recommendation to screening for the disease, along with several options for cancer detection, including CTC. (Although for individuals 76 to 85 years old, the task force recommends that the decision to undergo screening be an individual one, based on overall health and prior screening history.) Various groups have since reported increases in screening rates, due in part to increases in payment coverage for CTC by private insurance companies and initiatives such as the NCRRT's "80% by 2018" campaign.
But despite growing evidence supporting the benefits of CTC, CMS has refused to reconsider its 2009 decision to deny payment coverage for CTC cancer screening. (CMS does cover diagnostic CTC in symptomatic patients.) Nonetheless, screening proponents are encouraged by the prospect of CMS coverage following further support from the USPSTF and other societies, as well as accumulated scientific backing regarding safety and efficacy.
As recently as September 2018, advocates of CTC screening have called on the U.S. Congress to approve a bipartisan bill that could potentially pave the way for Medicare coverage -- the CT Colonography Screening for Colorectal Cancer Act.
Such efforts may have contributed to the early release of the USPSTF draft research plan, which includes the following sections:
- Key questions for systematic review: There are three key questions that the committee will use to assess available screening options in terms of their relative effectiveness, accuracy, and potential harms.
- Contextual questions: In addition to the key questions, the USPSTF has proposed seven contextual questions to facilitate the review of topics such as patient adherence to specific tests and other screening decision models.
- Analytic framework: A flowchart illustrates the workflow behind evaluating colorectal cancer screening in light of the key and contextual questions.
"Among the six screening options offered in the proposed framework, CTC is the only complete structural exam for direct visualization aside from colonoscopy," Yee said. One of the two new additions -- capsule endoscopy -- has yet to receive approval from the U.S. Food and Drug Administration.
- Research approach: The approach details characteristics and criteria that will determine whether a study should be included or excluded from the evidence report. Of note, the age limit for screening populations is at least 40 years.
- Decision model: The USPSTF will refer to the Cancer Intervention and Surveillance Modeling Network (CISNET) model profiles to inform the recommendation process.
More validated screening needed
The proposed key and contextual questions do not differ significantly from those posed in the prior review, according to Yee. This similarity indicates that the USPSTF will likely reissue its positive recommendation for CTC colon cancer screening, which may help boost current suboptimal screening rates: No more than 60% of all eligible individuals in the U.S. are currently getting screened, despite the fact that colonoscopy screening has been available for years.
"We are stuck in the ability to bring more patients in for screening," she said. "This is a preventable malignancy since we already know the precursor lesion is an adenomatous polyp -- but we can't bring in a large number of those eligible for screening. Thus, having more validated safe and effective screening tests is important."
A decision by the USPSTF to reinforce its stance on CTC colon screening may eventually lead to CMS reimbursement, which, in turn, would likely improve screening rates, she said. There are three current procedural terminology (CPT) codes for colorectal cancer screening, but CTC screening is still not reimbursable by CMS. In contrast, the five largest private insurance payors have long been reimbursing and covering CTC screening.
"I think CMS has been somewhat unreasonable holding CTC to a much higher bar than the other tests that have received CMS approval, even though CTC has much more science behind it," Yee said. "However, as we have moved from 2016, there have been additional peer-review publications addressing CTC's concerns, and I think we are in a good situation to bolster what was submitted in 2016."
The ACR Colon Cancer Committee is currently reviewing the proposed draft research plan and intends to provide a detailed response in the coming days. The window for public comment on the draft research plan will close on January 30, 2019.
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