Cologuard Lawsuits: Kickbacks, Humana Coverage, and Abbott Merger

Cologuard’s maker, Exact Sciences Corporation, has faced four significant waves of litigation: a federal whistleblower kickback case that settled for $13.75 million, an insurance coverage fight with Humana, a patent infringement battle against competitor Geneoscopy that has largely collapsed, and shareholder suits tied to the company’s 2026 acquisition by Abbott Laboratories. Consumers have also lodged hundreds of complaints over unsolicited test kits and surprise bills, though those grievances have mostly stayed outside the courtroom.

The $13.75 Million Kickback Settlement

The most significant Cologuard case was a federal False Claims Act suit brought by retired pathologist Dr. Niles Rosen as a whistleblower. Rosen alleged that Exact Sciences violated the Anti-Kickback Statute by mailing prepaid Visa gift cards to Medicare and Medicare Advantage beneficiaries who returned completed Cologuard kits. In his view, the gift cards were illegal inducements that generated fraudulent billing claims against government health programs.¹

The case, Dr. Niles Rosen v. Exact Sciences Corporation, was filed in the U.S. District Court for the Middle District of Florida. Exact Sciences denied wrongdoing and argued that the incentives were meant to promote colon cancer screening. The company pointed to an Advisory Opinion from the HHS Office of Inspector General to defend the program, but the plaintiffs challenged that opinion and a motion to exclude it was still pending as trial approached.¹

On September 26, 2023, on the eve of trial, the parties settled for $13.75 million. Most of the money went to the U.S. Treasury, with Rosen receiving a whistleblower award. Rosen’s lead attorney, Brandon Peak, said the OIG advisory opinion, which was “issued very late in the case and shortly before trial,” directly impacted the claims and influenced the final settlement figure.²

The Humana Coverage Lawsuit

In February 2016, Exact Sciences sued Humana in the U.S. District Court for the Western District of Kentucky, alleging that Humana had been systematically denying reimbursement for Cologuard since at least October 2014 across its commercial, Medicare Advantage, and other lines. At filing, the dispute involved 4,664 tests and more than $800,000 in outstanding claims.³

The complaint accused Humana of falsely classifying Cologuard as “experimental or investigational” even though the FDA had approved the test and CMS had issued a national coverage determination in August 2014. Exact Sciences also alleged that Humana had circulated fliers to Kentucky providers stating the test was not covered under commercial plans. The suit cited ERISA and a Kentucky statute requiring coverage for colorectal cancer screenings recommended by the American Cancer Society.⁴

Before the suit, Humana had sent a January 2016 letter agreeing to reprocess claims denied from January 1, 2016 forward, but Exact Sciences considered that inadequate because it did not cover the thousands of earlier denials.⁴ The public record does not show a final court ruling. The commercial relationship later reversed course: in August 2025, Humana and Exact Sciences announced an expanded partnership making the next-generation Cologuard Plus test in-network for roughly 5.8 million Humana Medicare Advantage members.⁵

The Patent War With Geneoscopy

In November 2023, Exact Sciences sued rival Geneoscopy, Inc. in the U.S. District Court for the District of Delaware, alleging that Geneoscopy’s ColoSense stool-based screening test infringed U.S. Patent No. 11,634,781, which covers methods for processing home-collected fecal samples to preserve biomarkers. The complaint also alleged false and misleading advertising.⁶⁷

In May 2024, the district court denied part of Geneoscopy’s motion to dismiss, letting the patent and advertising claims move forward. That same month, Exact Sciences filed a second complaint asserting infringement of a newly issued patent, U.S. Patent No. 11,970,746, also related to sample collection.⁷

Geneoscopy then attacked the patents themselves at the Patent Trial and Appeal Board. In July 2025, the PTAB found all 20 claims of the ‘781 patent unpatentable as obvious in light of prior art. Exact Sciences withdrew its request for a preliminary injunction against ColoSense the following month.⁸ In February 2026, the PTAB invalidated all challenged claims of the ‘746 patent as well, wiping out the last patent Exact Sciences had asserted in the litigation.⁹

The case, C.A. No. 23-1319-MN, is not over. Exact Sciences is still pressing false advertising claims, and Geneoscopy has filed counterclaims for breach of contract, misappropriation of trade secrets, false advertising, and unfair competition. Trial on the remaining claims is set for November 2026.⁹

Shareholder Suits Over the Abbott Merger

In November 2025, Abbott Laboratories announced an agreement to acquire Exact Sciences in a deal valued at roughly $21 billion in equity and $23 billion including debt.¹⁰ By February 2026, three shareholder suits had been filed in New York, alleging that the proxy statement Exact Sciences mailed in January 2026 contained false or misleading disclosures or omitted material information. At least one suit also alleged violations of Wisconsin securities law.¹¹

Exact Sciences denied the allegations but issued supplemental financial and valuation disclosures to head off delays.¹¹ The acquisition closed on March 23, 2026, and Exact Sciences became a subsidiary of Abbott.¹²

Consumer Complaints, Unsolicited Kits, and Surprise Bills

Outside the courtroom, the most common complaints against Exact Sciences involve unrequested test kits and unexpected charges. By October 2025, the Better Business Bureau of Wisconsin had recorded 376 complaints against the company. Consumers described receiving kits they never asked for and then seeing charges of $500 to $700. In one case, an Exact Sciences representative told a consumer she was among 400,000 members of her insurance plan targeted for outreach, even though her physician confirmed never ordering the test.¹³

Exact Sciences says the kits are not unsolicited. According to the company, it ships only after a health plan supplies a list of eligible members and a licensed clinician places the order, and 94% of patients have no out-of-pocket costs.¹³

A separate billing problem has affected patients who got a positive Cologuard result. Under the Affordable Care Act, routine cancer screenings must be covered without cost-sharing, but some insurers coded the follow-up colonoscopy as “diagnostic” and billed the patient. CBS News reported the case of Lianne Bryant of Missouri, who was billed $1,900 for a follow-up colonoscopy and successfully appealed after five months.¹⁴ A 2023 Medicare rule change classified follow-up colonoscopies after a positive non-invasive screening as preventive services with no out-of-pocket cost, and federal guidance now requires most commercial insurers to do the same for eligible patients.¹⁵

1
Wilbanks Gouinlock. Exact Sciences Agrees to Pay $13.75 Million to Resolve Kickback Case
2
Daily Report Online. GA Lawyers Get $13.75M Settlement for Feds, Patient in Cologuard Kickbacks Suit
3
GenomeWeb. Exact Sues Humana for Denying Cologuard Payment
4
AJMC. Humana Uncommitted on Cologuard Test, Faces Lawsuit
5
Exact Sciences. Exact Sciences and Humana Expand Colorectal Cancer Screening Partnership With Cologuard Plus Test
6
PR Newswire. Exact Sciences Files Patent Infringement Lawsuit Against Geneoscopy
7
Exact Sciences. Court Ruling Enables Exact Sciences to Proceed With Lawsuit Against Geneoscopy
8
Geneoscopy. Geneoscopy Wins Patent Trial and Appeal Board Decision Invalidating All 20 Claims of Exact Sciences’ ‘781 Patent
9
BioSpace. Geneoscopy Wins Second Patent Trial and Appeal Board Decision Invalidating All Challenged Claims of Exact Sciences’ ‘746 Patent
10
Abbott. Abbott to Acquire Exact Sciences
11
The Globe and Mail. Exact Sciences Faces Shareholder Lawsuits Over Abbott Merger
12
Abbott. Abbott Acquisition of Exact Sciences Set to Close on March 23, 2026
13
KPRC 2 (Click2Houston). Medical Company Ships Unwanted Cancer Tests to Homes, Sparking Anger and Privacy Concerns
14
CBS News. Cologuard Unexpected Bill Colon Cancer Screening
15
Exact Sciences. Coverage Requirements