Biotheranostics Breast Cancer Index: Testing Outside the Supported Patient Population

In the Biotheranostics Breast Cancer Index settlement, the company agreed to pay $2 million to resolve allegations that it submitted, and caused others to submit, Medicare claims for unnecessary breast cancer tests. The government alleged that Biotheranostics knowingly promoted and performed the test for patients whose remission and medication histories fell outside the circumstances supported by clinical trial data and guidelines. The alleged mismatch put Medicare on the bill for tests the patients did not need.

The Department of Justice announced the settlement on April 19, 2018. Biotheranostics was a diagnostic laboratory testing company in San Diego, California. The case concerned the medical necessity of its Breast Cancer Index tests, known as BCI, for the Medicare patients receiving them.

What the Government Alleged About BCI Testing

The United States alleged that Biotheranostics knowingly promoted and performed BCI testing for breast cancer patients who had not been in remission for five years and who had not been taking tamoxifen. According to the government’s announcement, testing those patients was not reasonable and necessary based on published clinical trial data and clinical practice guidelines.

That is a patient-specific allegation. The government tied the claim to remission and treatment history, facts that belong in the patient’s medical record. A breast cancer diagnosis alone did not answer the question the government was asking about these tests: whether the patient’s circumstances supported the testing being billed to Medicare.

The allegation also reached the promotion of the test. The government alleged that Biotheranostics pushed the test for those patients, performed it, and submitted or caused the resulting claims. That connects what the laboratory was selling to the information held by the clinician who ordered it. A sales account and a patient account can describe the same test very differently.

The Clinician Holds the History, the Laboratory Bills

The party billing Medicare depends on information held in another office. Under Medicare’s diagnostic-test ordering and documentation rules, the ordering practitioner keeps the medical record explaining why the patient needs the test. The laboratory must retain what the practitioner sends and documentation showing that its claim accurately reflects that information.

That division matters in a case about remission and medication history. The clinician’s record may explain the patient’s treatment over time. The laboratory’s files show what part of that history reached the people performing and billing the test. Comparing the files can reveal a gap between the circumstances the clinician documented and the circumstances on which the claim depended.

How Can Laboratories Detect and Deter Fraud?

The safeguards start with an order form that records why this patient needs this test, and clear communication with the ordering clinician. The Department of Health and Human Services Office of Inspector General says in its laboratory compliance guidance that requisitions should ensure an independent medical-necessity decision for each test the laboratory will bill.

The journal Laboratory Medicine explained this operational problem in its June 1997 article Model Plan Helps Laboratories Fight Fraud. Describing the inspector general’s model plan, the article reported recommendations for uniform requisitions with space to document each test’s medical necessity through a diagnosis code. It also described written notices to ordering physicians explaining medical-necessity policy, the components of laboratory profiles and how those profiles would be billed.

The laboratory helps shape what the ordering practice sends it through the order form, or requisition, and its instructions. In a case about testing outside supported patient circumstances, we examine whether those communications drew attention to the relevant clinical history and how the laboratory responded to the information it received.

What Evidence Is Needed to Prove Fraud?

The key evidence connects the patient’s remission and medication history to the BCI order, the test performed, the Medicare claim and what the laboratory knew. We examine those connections with the insider who understands the business. The government’s allegation of knowing promotion makes the laboratory’s communications with ordering clinicians part of that inquiry.

Marketing and clinical-support material answer another question: what patient population was the laboratory encouraging clinicians to test? We compare those communications with the clinical support for the use being promoted and with the information accompanying the orders. That is how a concern about a sales message becomes a specific inquiry into tests and claims.

An insider’s knowledge helps explain the decisions between those documents. Someone in an ordering practice may know why a test was requested and what history was sent. Someone in laboratory client services or billing may know how missing clinical information was handled. We work with that knowledge to identify where the account changes as it moves from the practice to the laboratory to Medicare.

Different Tests, Different Patient Criteria

GenomeDx Biosciences‘ Decipher settlement concerned allegations of prostate cancer testing without supporting patient risk factors, while the Biotheranostics allegations concerned remission and tamoxifen history.

A Laboratory Insider’s View of the Claim

The Biotheranostics case puts clinical history at the center of a laboratory fraud inquiry. Understanding how the ordering practice and laboratory exchanged patient information is how we approach a concern involving that pattern.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know What the Laboratory Was Told

If you know how a cancer-testing laboratory’s sales message, patient information and Medicare claims diverged, talk with our whistleblower experts. We build the case with you and bring in laboratory fraud whistleblower lawyers who understand medical-necessity disputes and cancer-test billing. You bring the view from inside the business; we bring the judgment and partnership to pursue it with you.