Humana Uncommitted on Cologuard Test, Faces Lawsuit

A noninvasive colorectal cancer screening test manufactured by Exact Sciences, which received CMS coverage within months of its FDA approval, is not included under Humana’s coverage policy

A noninvasive colorectal cancer screening test manufactured by Exact Sciences, which received CMS coverage within months of its FDA approval, is not included under Humana’s coverage policy. Consequently, the manufacturer is suing the insurance company for refusing to pay for 4664 screenings of Humana enrollees, with outstanding claims worth more than $800,000.

According to a report in WisBusiness, the Cologuard test is currently covered by Anthem BlueCross of California for its 4.5 million beneficiaries and the manufacturer is in the process of negotiating contracts for the screening test with 5 other insurance carriers. Humana’s website specifies that it will allow this service for their Medicare beneficiaries who are eligible for coverage once in 3 years.

WisBusiness reports that Exact Sciences, in their court filing, has claimed that Humana is in violation of state and federal laws with their wholesale refusal to cover the test for their commercial plan members. “If Humana’s conduct is allowed to continue, it threatens irreparable harm to Exact as well as the patients who depend upon the test that Exact provides,” the filing says. This is especially important in states that have mandated coverage for colorectal cancer. According to the National Colorectal Cancer Research Alliance, 30 states and the District of Columbia have passed laws that require healthcare providers to cover the cost of colon cancer screening. Exact Sciences has filed its claim in Kentucky, which is one of the 30 states that mandate coverage.

Humana also used a tactic to deter physicians from using Cologuard to screen their patients; the company circulated fliers among their in-network providers in Kentucky that said “Cologuard is not covered under Humana’s commercial plans.” Lawyers hired by Exact Sciences sent a notice to Humana asking they stop the distribution of these fliers. Humana claims they have done so.

The US Preventive Services Task Force, however, has listed Cologuard as an alternative test for colorectal cancer screening, and the Task Force recommends the following screening tests for average-risk adults between 50 and 75 years of age:

  • A guaiac fecal occult blood test (FOBT) or fecal immunochemical test (FIT) every year
  • A colonoscopy every 10 years
  • Flexible sigmoidoscopy every 5 years with FOBT or FIT every 3 years

Humana has agreed to process claims for Cologuard reimbursement that were denied beginning January 2016. However, Exact Sciences is not satisfied and expects the insurer to cover all outstanding claims—not only in the 30 states that mandate coverage, but in the rest of the country as well, which might be a much harder bargain to strike.