Cologuard, the colorectal cancer screening test by Madison-based Exact Sciences, got a boost this month when a prominent task force dropped its “alternative” designation for the test and recommended it with other tests.
But it’s not clear if more doctors will order Cologuard now or if insurers will be required to cover the home-based stool test.
“For myself personally, it really doesn’t change anything,” said Dr. David Feldstein, an internal medicine doctor at UW Health who heads up a committee that decides which screening tests to recommend at UW Health.
“I like to make sure the evidence really supports what we’re doing,” Feldstein said. “That’s why I don’t recommend ... Cologuard.”
Under the Affordable Care Act, insurers must cover tests recommended by the U.S. Preventive Services Task Force without any cost to consumers. But the task force, on June 15, recommended colorectal cancer screening in general and listed seven types of tests. It’s not clear if insurers have to cover all of them.
“It’s their discretion about what method they would choose to cover,” said Linda Baumann, a retired nursing professor at UW-Madison who served on the task force until December. “Whether Cologuard would be paid for each time, I can’t comment on that. I don’t know.”
Kevin Conroy, CEO of Exact Sciences, said insurers are now “obligated” to cover Cologuard, and more doctors will order it.
“The notion that (insurers) could pick and choose would undermine the very intent of the (Affordable Care) Act,” Conroy said. “This will have a favorable impact on the use of the test by physicians.”
The company expects to complete 240,000 tests this year, an estimate that has not changed since it was made last year. No estimate has been released for next year.
The task force issued a draft recommendation in October that listed Cologuard and virtual colonoscopy as alternative methods to colonoscopy and other preferred tests because there was less evidence supporting the alternatives.
Exact Sciences’ stock price plummeted, and the company pulled out of the Judge Doyle Square redevelopment south of Capitol Square, leaving the project up in the air.
The company said it would expand at University Research Park instead.
Exact Sciences and high-profile organizations such as the American Cancer Society and Mayo Clinic asked the task force to upgrade Cologuard in its final determination.
In the final ruling, the task force listed Cologuard and virtual colonoscopy along with colonoscopy, flexible sigmoidoscopy and other stool tests.
“The terms ‘recommended’ and ‘alternative’ were very confusing, and so those were taken out,” Baumann said. “We’re saying, ‘Get screened for colorectal cancer, and there are number of ways to do that.’”
Exact Sciences’ stock price closed Friday at $11.54, up from $9.39 on June 14, the day before the final recommendation. On the day before the draft recommendation in October, the stock price was $18.53.
Dr. Patricia Golden, a family medicine doctor at Wheaton Franciscan Medical Group in Franklin, said the task force upgrade will lead more doctors to use Cologuard.
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“With the task force backing, this is not experimental,” Golden said. “This is an appropriate standard of care.”
But Dr. Michael Allan, a gastroenterologist at Dean Clinic, said Cologuard remains unproven compared to colonoscopy.
Cologuard, recommended every three years, costs $509. A colonoscopy and its related costs are considerably more expensive, but it is recommended every 10 years and has more evidence, Allan said.
“As (Cologuard is) priced right now, from a public health perspective, you’re still better off going in the direction of colonoscopy in terms of cost and colon cancer prevented,” he said.
Dr. Gary Griglione, a gastroenterologist at UnityPoint Health-Meriter, said Cologuard detects only about half of polyps, precancerous lesions that colonoscopy is more likely to find.
“We’re not screening for cancer; we’re screening for pre-cancer,” Griglione said. “What if (Cologuard) doesn’t turn positive until it’s a large enough polyp you can’t remove or actually has cancer in it?”
Feldstein said Cologuard can be useful for patients who refuse colonoscopies.
But patients must realize that if their Cologuard test is positive, they will need a colonoscopy to determine if cancer is present, he said.
The UW Preventive Health Care Clinical Practice Guideline Steering Committee, which Feldstein leads, didn’t recommend Cologuard when it updated its colorectal cancer screening recommendations in early 2015.
The committee will revisit the issue again early next year. Will Cologuard be recommended?
“I’m not sure; it will be interesting,” Feldstein said. “The evidence really hasn’t changed.”
The main health insurance plans in the Madison area, along with Blue Cross and Blue Shield of Wisconsin, cover Cologuard.
Feldstein, former associate medical director for Unity Health Insurance, said it’s up for debate if the latest task force recommendation requires insurers to cover the test.
“Different insurance companies may interpret it differently because it is so vague,” he said.
But James Stansel, a lawyer in Washington, D.C., who served as acting general counsel for the U.S. Department of Health and Human Services, said insurers have to cover Cologuard because the task force listed it with the other tests in its “grade A” recommendation for colorectal cancer screening.
“It must be covered at zero cost-sharing,” Stansel said.
[Editor's note: This story has been updated to reflect a correction. In the original, the last name of attorney James Stansel was misspelled.]