by Ben Vernia | October 4th, 2023
On October 2, the Department of Justice announced that California-based Genomic Health, Inc., has agreed to pay $32.5 million to settle allegations that the company submitted false claims to Medicare for testing of cancer patients. According to DOJ’s press release:
Genomic Health, Inc. (GHI), a Delaware corporation headquartered in Redwood City, California, has agreed to pay $32.5 million to resolve allegations that it violated the False Claims Act by engaging in a nationwide scheme to improperly bill Medicare for certain laboratory tests used to diagnose and treat cancer patients. GHI is a wholly owned subsidiary of Exact Sciences Corporation, which acquired GHI in November 2019.
GHI provides genomic-based clinical diagnostic tests. Its principal test, Oncotype DX®, is used for patients diagnosed with breast, colon and prostate cancer. The United States alleged that GHI perpetrated a scheme to evade Medicare’s 14-Day Rule, which governs the billing of genomic laboratory tests like Oncotype DX®.
During some or all of the time period covered by the settlement, Medicare’s 14-Day Rule prohibited laboratories from separately billing Medicare for covered tests if a physician ordered the test within 14 days of the patient’s discharge from a hospital stay in an inpatient or outpatient setting. For inpatient beneficiaries, such tests were covered under a lump-sum payment hospitals receive from the Medicare Program called the Diagnosis-Related Group (DRG) payment. For outpatient beneficiaries, Medicare’s 14-day Rule required (for most of the relevant time) tests ordered within 14 days of the patient’s discharge to be billed to the hospital but the hospital could then seek reimbursement from Medicare. However, if the test was performed more than 14 days after discharge from a hospital stay either in an inpatient or outpatient setting, then Medicare’s 14-Day Rule permitted laboratories to bill Medicare directly for the test. The United States contends that GHI improperly manipulated the 14-Day Rule in four ways:
* GHI sought direct reimbursement from the Medicare Program for claims on behalf of Medicare beneficiaries, when Oncotype DX® tests were ordered and submitted for testing within 14 days after an inpatient discharge. By submitting separate claims for these tests, GHI received direct payment for tests that should have been covered as part of the DRG payment to the hospital.
* GHI sought direct reimbursement from the Medicare Program for Oncotype DX® tests ordered within 14 days of a beneficiary’s outpatient procedure. By submitting separate claims for these tests, GHI received direct payment from Medicare for tests that should have been billed to the hospital.
* GHI conspired with and encouraged hospitals and physicians to cancel and reorder Oncotype DX® tests and failed to discourage providers who ordered tests within 14 days from canceling and reordering the tests after the 14-day time period had elapsed.
* GHI failed to send timely invoices to hospitals for laboratory services that fell under the 14 Day Rule and instead wrote off the unpaid fees for laboratory services, thereby violating the Anti-Kickback Statute.
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The whistleblowers in two separate cases will receive $5,687,500, the government announced (a 17.5% relators’ share).
