Adding a test that evaluates stool samples for DNA and protein biomarkers to the list of tools providers can use to boost quality ratings is seen as an additional boost for Cologuard.
A test that could replace the colonoscopy for routine colorectal cancer screening will be included in the 2018 Medicare Advantage Star Ratings, giving beneficiaries the option of taking a screening test at home, without the discomfort and days of preparation needed for the invasive procedure.
Cologuard, approved by FDA in August 2014, is rapidly gaining acceptance among payers, providers, and entities that set guidelines for quality care. The test, which analyzes DNA and protein biomarkers in a stool sample, was added to the 2017 Health Effectiveness Data and Information Set (HEDIS) quality measures set by the National Committee on Quality Assurance (NCQA). CMS’ decision this week to include the test in the Star Ratings gives providers and insurers added incentive to use it, because doing so can help them raise their quality scores.
“This is the perfect test for people on their 50th birthday,” said Barry M. Berger, MD, FACP, who is chief medical officer for Exact Sciences, which makes the test. For those treating the Medicare population, Berger said Cologuard’s inclusion in the Star Ratings offers a chance to get 3 years’ worth of credit for each person screened, since Cologuard is recommended at 3-year intervals.
An Essential but Dreaded Test
Colorectal cancer is the second most deadly cancer in the United States, after lung cancer. While cancers caught in early stages have a 90% survival rate, those caught late have only a 12% survival rate, the American Cancer Society (ACS) reports. CDC data show that 136,119 people were diagnosed with colorectal cancer in 2013, and 51,813 died from the disease. Recent data show that while screening has helped reduce the death rate among seniors, more young adults are being diagnosed, as the disease is linked to obesity and poor nutrition.
For years, a colonoscopy has been the standard order for those turning 50, and it had to be repeated every 10 years or more frequently if tiny polyps were found. The problem? Colonoscopies are among the most dreaded tests recommended for older Americans. A colonoscopy can vary in cost from just under $1000 to above $8000, but recent research suggests that’s not what keeps people away: being tested requires 2 days on a liquid diet, going off certain medications, and taking a day off from work. Thus, providers looking to boost their screening rates have welcomed an alternative.
Analysts and advocacy groups say Cologuard could be a game-changer in reducing the death rate from colorectal cancer, and it has been embraced by the US Preventive Services Task Force (USPSTF), NCQA, and the ACS. Unlike fecal immunochemical testing (FIT), which tests for hidden blood in the stool, the Cologuard test also looks for abnormal DNA in cells shed from the colon.
Screening is simple and noninvasive: Cologuard requires a prescription, but after that a kit is mailed to a patient’s home, where a single stool sample is collected and returned for testing.
While ACS would like to see colorectal cancer screening rates above 80% for those 50 to 75 years of age, the rate was only 58% in 2013. A study in The American Journal of Managed Care® suggests cost is not the main barrier to increasing the share of people screened this way. The Affordable Care Act eliminated patient cost-sharing for colonoscopies, but researchers found no appreciable increase in the number of people screened.
Both Berger and the USPSTF note the appeal of the DNA test to those who have previously avoided a colonoscopy; Berger cited a study that showed 42% of those who take a Cologuard test have never been screened. “People averse to screening in the past now have an attractive option,” he said.
In its statement, the USPSTF highlighted the need to boost participation rates in cancer screening, saying that “clinicians should consider engaging patients in informed decision making about the screening strategy that would most likely result in completion, with high adherence over time.”
Accurate, but Not for Everyone
Evidence of the test’s accuracy appeared in the New England Journal of Medicine just before FDA approval in 2014. That study of 9989 patients found the test had a 92.3% sensitivity rate for cancer and a 42.4% sensitivity rate for detecting precancerous lesions. The detection rate of polyps with high-grade dysplasia was 69.2%, compared with 46.2% for FIT.
Berger said right now Cologuard is only approved for screening, not surveillance of patients who have been treated for colorectal cancer. However, a study under way in the Netherlands will examine whether Cologuard is appropriate for this use.
The test is not recommended for patients with symptoms of colorectal cancer or those at high risk, including those with a family history of the disease or conditions like Crohn’s disease. Patients who get a positive result are instructed to follow up with a diagnostic colonoscopy.
Cologuard costs $649, although Medicare pays less. Insurers are increasingly covering the test outside of Medicare (Aetna recently added it). Berger said the lower cost of the test adds to its value for payers, since it effectively screens patients without triggering overdiagnosis of tiny polyps that would call for repeat colonoscopies within the 10-year window.
Exact Sciences officials hope Cologuard will become the new standard of care for cancer screening. “Cologuard is expanding the pool of patients who have been screened for colon cancer and maintaining very high levels of physician and patient satisfaction,” Kevin Conroy, Exact Sciences’ president and CEO, said in a statement. “These factors are central to the Star Ratings program and, as a result, are important to Medicare Advantage plans. Cologuard's unique characteristics can help Medicare Advantage plans provide better colon cancer screening to their patients, while helping increase their Star Ratings.”