Agendia MammaPrint: The 14-Day Rule and Two Separate Settlements

In the Agendia MammaPrint settlement announced in 2020, the company agreed to pay $8.25 million over an alleged nationwide scheme to delay test orders so it could bill Medicare directly. Separate settlements with Agendia and two referring providers announced in 2025 totaled more than $3,750,000 over allegedly unnecessary testing through standing or automatic orders and payments for referrals. For someone inside a laboratory or hospital, the distinction matters: one case followed the dates attached to an order, while the other followed how the order was generated and what the referring provider received.

Agendia is a molecular diagnostics company based in Irvine, California. Its MammaPrint test analyzes gene activity in a breast cancer tumor to predict the risk of recurrence. In the earlier case, the Department of Justice alleged that a test already ordered for a patient was held back until its timing suited the billing arrangement. A former Lourdes Hospital employee brought the whistleblower case, and the government joined it for settlement.

The Earlier Settlement Turned on Who Could Bill Medicare

The Justice Department’s July 1, 2020 announcement described an alleged agreement between Agendia and hospitals to get around Medicare’s 14-Day Rule. During the period covered by the settlement, the rule prevented a laboratory from separately billing Medicare for tests on specimens when a physician ordered the test within fourteen days of the patient’s hospital discharge. The announcement described that restriction as applying to both inpatient and outpatient encounters.

That billing boundary gave the delay a financial purpose. Under the hospital payment arrangement, the hospital paid the laboratory for testing associated with the encounter. If the laboratory could bill Medicare separately, the payment would come directly from the program. The government alleged that Agendia manipulated the timing to obtain that direct payment for tests already ordered within the restricted period.

An Order Canceled and Placed Again

One alleged method started with Agendia refusing to perform a MammaPrint test when the Medicare patient had left the hospital less than fourteen days earlier. According to the government, Agendia canceled the order and asked the physician to submit it again after that period had passed.

The physician had already asked for the test. The alleged cancellation and resubmission supplied a later order for billing purposes. We help insiders connect that first request, the cancellation and the instruction to send it again to the billing decision.

The Medicare Hold and the Confirmation Date

The second alleged method kept the original order but put it into what Agendia employees called a “Medicare hold.” The government said Agendia automatically held orders for Medicare patients and refused to test their specimens until fourteen days after discharge.

Staff allegedly set a calendar reminder for the fourteenth day, contacted the ordering doctor and asked for confirmation. Agendia then used the confirmation date to bill Medicare instead of the date the doctor had originally ordered the test.

That is the revealing detail in the government’s account. A later confirmation of an existing request became the date used for billing. The original request, the reminder and the call back to the physician would each tell a part of that story. Someone who handled the hold or made the call could know why the date changed, even without seeing the eventual claim.

The Rule Changed for Outpatient Molecular Testing

The Centers for Medicare & Medicaid Services introduced an exception effective January 1, 2018 for qualifying molecular tests on specimens collected during hospital outpatient encounters. When its conditions were met, the exception used the test-performance date and allowed the performing laboratory to bill Medicare directly.

Lourdes Paid Separately for Holding the Tissue

Lourdes Hospital in Paducah, Kentucky, paid $211,039 in 2017 to settle its own part of the alleged arrangement.

The government alleged that Lourdes held tissue from breast biopsies for fourteen days or longer after discharge before sending it to Agendia. It also held the test orders, despite knowing the specimens should be sent immediately. The stated purpose was to let Agendia bill Medicare separately. According to the government, Lourdes thereby avoided paying Agendia for the tests.

In the government’s account, a patient’s breast biopsy tissue waited on a billing calendar. The alleged arrangement left Medicare paying for testing the hospital should have paid for.

The Later Settlements Concerned Orders and Referral Payments

The May 21, 2025 announcement described separate agreements with Agendia, Knoxville Comprehensive Breast Center and Knoxville Dermatopathology Laboratory. Agendia agreed to pay at least $3,250,000, a second settlement over the same test, with possible additional payments if the privately held company is sold. The breast center agreed to pay $322,500 and the dermatopathology laboratory $207,500.

These settlements concerned a different alleged arrangement. The government said Agendia submitted false MammaPrint claims to Medicare, Medicaid and other government payors from 2019 through 2022. It alleged that Agendia caused referring providers to order tests that were not reasonable or medically necessary through standing or automatic orders. It also alleged that improper compensation induced referrals.

The government said the breast center and the dermatopathology laboratory worked together and knowingly participated in obtaining referrals for unnecessary testing, referrals induced by Agendia’s compensation, or both. The later settlement resolved claims brought by two whistleblowers in separate cases.

The Office of Personnel Management inspector general also identified costs to the Federal Employees Health Benefits Program from unnecessary testing in its statement on the settlement.

Standing Orders and the Individual Patient

An automatic order can turn a decision about an individual patient into a repeatable source of test claims. That was the concern in the later Agendia allegations: the government said the standing or automatic orders produced MammaPrint testing that was not reasonable or medically necessary.

The industry has long recognized the importance of what the requisition records. In Model Plan Helps Laboratories Fight Fraud, published in Laboratory Medicine in 1997, an account of the federal laboratory compliance plan described forms with space for the physician to document the medical necessity of each test through a diagnosis code. It also described monitoring existing standing orders for continued validity.

Those are different questions from whether an order reached the laboratory. What clinical reason accompanied it, and did that reason still support the testing? In the Agendia case, an insider’s knowledge of how a standing order was created and used could connect the referring practice’s routine to the claims the laboratory submitted.

Do Doctors Get Kickbacks for Ordering Tests?

The government alleged that referring providers in the later Agendia case received benefits to induce MammaPrint orders. Its account included extravagant dinners, excessive or improper honoraria, gift cards, payments per referral and monthly flat-rate payment arrangements.

That range matters to someone who saw the payments. An alleged inducement could be a benefit delivered at an event, compensation described as an honorarium, or a recurring payment. A per-referral payment connected money to an order directly.

The government’s allegation connects those benefits to claims submitted to public health care programs. The order was how the test entered the laboratory. The referral arrangement was how the government alleged that business was obtained. A person familiar with either side may know something the billing record alone would not explain.

A Standing Order Under Another Name

In a separate case, a whistleblower alleged that Genotox Laboratories renamed standing orders as custom toxicology profiles to avoid regulatory scrutiny.

Genomic Health and the Hospital Bill That Went Unpaid

Lourdes allegedly avoided the testing bill through delayed orders and specimens that allowed Agendia to bill Medicare, while Genomic Health allegedly wrote off unpaid hospital fees for testing covered by the same rule.

What Your View of the Orders Can Reveal

These Agendia cases show why knowledge from inside a referring institution can matter as much as knowledge from inside the laboratory. The hospital sees the patient’s discharge and the specimen’s departure. The laboratory sees the order it receives and the date it uses for billing.

We work with laboratory and hospital insiders to connect the order history, specimen handling, billing decision and referral relationship. For a timing case, that means understanding why an existing order acquired a later date. For automatic testing or referral payments, it means understanding who set the arrangement and what it caused the laboratory to bill.

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

You Know Why the Order Changed

If you handled held specimens, replacement orders, automatic testing arrangements or payments to referring providers, speak to one of our whistleblower experts about what you saw. We build your healthcare laboratory fraud case with you and bring in whistleblower lawyers who understand molecular testing, hospital billing and referral arrangements. We stay beside you through the whole journey to build your strongest laboratory whistleblower case.