Task Force Grants Broad Support For Colorectal Cancer Screening Tools
By David Filmore
Around The Industry
June 16 2016 6:00 PM
Executive Summary
The US Preventive Services Task Force said colorectal cancer screening is effective for those aged 50 to 75. It recognizes the potential for a range of methods, from standard colonoscopy to CT colonography, to blood and fecal DNA testing, to be used to increase screening rates. The recommendations could help drive coverage and adoption for several firms’ products.
The federal task force that serves as the primary arbiter of what screening tests should be performed by providers and covered by insurers gave a broad-based thumbs-up to various modes of colorectal screening.
The US Preventive Services Task Force on June 16 granted its strongest “A”-rated recommendation to routine colorectal cancer screening for everyone aged 50 to 75, remaining essentially neutral on the type of test used to perform the screening. While USPSTF’s prior 2008 policy specifically recommended colonoscopy, fecal immunochemical tests, fecal occult blood tests (FOBTs) and flexible sigmoidoscopy (combined with FOBTs), the new policy has a broader reach.
“Instead of emphasizing specific screening approaches, the USPSTF has instead chosen to highlight that there is convincing evidence that colorectal cancer screening substantially reduces deaths from the disease among adults aged 50 to 75 years, and that not enough adults in the United States are using this effective preventive intervention,” the task force said in its recommendations, posted on its website and in the Journal of the American Medical Association.
The USPSTF says it “acknowledges that there is no ‘one-size-fits-all’ approach to colorectal cancer screening, and seeks to provide clinicians and patients with the best possible evidence about the various screening methods.”
This approach could be a boon for several colorectal-cancer screening alternatives, including new fecal and blood DNA tests, and computed tomography (CT) colonography.
In particular, the USPSTF recommendations mention each of these options, including DNA-based fecal testing, offered by Exact Sciences Corp.‘s Cologuard and FDA-approved in 2014, and the first blood-based test approved for colorectal cancer screening, Epigenomics AG‘s Epi proColon SEPT9 DNA assay, approved earlier this year. (See “Epigenomics’ Epi proColon Blood Test Finally Makes The Grade With FDA” — “The Gray Sheet,” Apr. 13, 2016.)
Under federal regulation, private payers participating in insurance exchanges are required to cover services rated as “A” and “B” by USPSTF without cost-sharing. Medicare is not required to cover these services, but if decides to do so, it must cover “A”- or “B”-rated services without co-pays.
Because of this legend, blue lotus came to be associated with impotence, and urine may be lost when the person generic for viagra coughs or sneezes. Giles Brindley had showed the audience present at a conference that erection is possible cheapest cialis in australia with the intake of drugs. And as the Intima Media becomes ‘fatter’ so the artery becomes canada levitra blocked. In case emotions pertaining to totally awesome sadness or their store discount cialis even a hopelessness, followed by way of exhaustion, so changes attached to urge for food in addition to sleepiness patterns persist towards various weeks, my person could also be diagnosed containing medical depression. In addition to providing an “A” recommendation for screening individuals who are 50 to 75 years old, USPSTF also gave a “C” grade for screening of 76-85 year-olds, saying it should be an individual decision for that population.
USPSTF: No ‘One-Size-Fits-All’ Approach
The task force does not suggest all the screening methods are equal. It specifically details the benefits and harms of each, for instance, noting that evidence for CT colonography is limited to studies of its “test characteristics,” and that it comes with risks of over-diagnosis.
“The USPSTF acknowledges that there is no ‘one-size-fits-all’ approach to colorectal cancer screening and seeks to provide clinicians and patients with the best possible evidence about the various screening methods to enable informed, individual decision-making,” the recommendation states.
While the USPSTF recommendation does not guarantee Medicare coverage, it could make it more likely that CMS will reconsider its coverage policies for various colorectal cancer screening tests. The Medical Imaging & Technology Alliance says that is exactly what it would like to see happen.
For example, CT colonography potentially offers a less-invasive alternative to standard colonoscopy, but has struggled under a national Medicare non-coverage policy established in 2009. (See “Medicare Denies Coverage Of CT Colonography For Cancer Screening” — “The Gray Sheet,” May 18, 2009.)
“We hope this will encourage the Centers for Medicare & Medicaid Services to provide national coverage of CT colonography, granting more beneficiaries access to early detection and lifesaving treatment, and saving millions of lives,” said Patrick Hope, MITA’s executive director.
Epi proColon is also not yet covered by Medicare. The test, which was approved by FDA in the middle of USPSTF’s review, just qualified for inclusion in the recommendation report, according to USPSTF. “A single test characteristic study met the inclusion criteria for the systematic evidence review supporting this recommendation statement; it found the SEPT9 DNA test to have low sensitivity (48%) for detecting colorectal cancer.“
The firm says it expects the inclusion of the test in the report to expand adoption and coverage for the assay.
Epigenomics says the new recommendations recognize “the potential role of our novel blood-based test in colorectal cancer screening, especially in driving patient compliance in individuals who are reluctant to collect stool samples or undergo colonoscopy.”
“We continue to work multiple paths for CMS coverage,” Noel Doheny, CEO of Epigenomics’ US subsidiary, told The Gray Sheet.
Cologuard, meanwhile, is already covered by Medicare. But Exact Sciences CEO Kevin Conroy says the company is “pleased with the clarity of these recommendations and expect they will expand and promote utilization of Cologuard as an innovative colon cancer screening option.”
*Follow David Filmore