The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) has expressed little confidence in genetic tests that supposedly predict common cancers. The decision raises doubts about whether the CMS will authorize Medicare coverage for such tests.
“This is such a promising and exciting field, but the excitement is far ahead of the data,” said Diana Zuckerman, a panel member and president of the National Center for Health Research, an advocacy organization. These tests “could be so helpful if only we knew more.”
Specifically, there was a concern among committee members who met Tuesday about the lack of data regarding clinical utility, which indicates if a test result was actually helpful to a consumer.
“The evidence got very thin, very quickly,” said Dr. Beverly Guadagnolo, a panelist and associate professor in the radiation oncology department at the University of Texas.
Industry stakeholders present at the meeting disagreed. “Two hundred-plus labs around the country wouldn't be doing these tests if they didn't have clinical utility,” Dr. Jan Nowak, medical director of molecular diagnostics and cytogenetics at NorthShore University HealthSystem, Evanston, Ill., said during public comments.
Another leading concern was to ensure people did not undergo unnecessary chemotherapy. “We need to be on the side of the angels and minimize access to drugs that don't necessarily need to be given,” said Dr. Josef Fischer, a panelist and professor in the surgery department at Harvard Medical School and Beth Israel Deaconess Medical Center.
The eight-member panel was asked to vote on a scale of 1 to 5 on how confident members were that the tests they were reviewing would actually benefit Medicare beneficiaries by bettering quality of life, helping them avoid inappropriate anti-cancer treatments or death. The tests that were up for consideration claim they help predict the chances of colon, rectum, breast and lung cancers.
Panel member votes were collected and averaged. Most of the tests received an average score under 3, though a test related to breast cancer rated higher at 3.8. Another test meant to find cancerous lung cancer genes scored the lowest at 1.375.
The panelists also were asked to discuss if they would feel more comfortable with a test being used by beneficiaries if it were a laboratory-developed test from a facility certified under the Clinical Laboratory Improvement Amendments or a test that received Food and Drug Administration approval or clearance. Members seemed more comfortable with an FDA-approved test.
It's unclear what direction the CMS will take moving forward. MEDCAC is generally considered influential, but the agency recently decided to not concur with a committee vote to not recommend Medicare coverage of annual CT scans to detect lung cancer in heavy smokers.
During the meeting, CMS liaison Dr. James Rollins indicated that any future coverage given to these type of tests would need to prove clinical utility. Today, most entities developing these tests focus on proving analytical validity, how accurately a test detects a specific genetic variant, or clinical validity, how well the genetic variant is being analyzed.
