Corning: The Laboratory Business and the Ordering Decision

The Corning laboratory case alleged that a single checkbox led physicians to order two prostate-cancer blood tests when only one was needed. In its October 13, 2000 opinion, the federal court in New Mexico described allegations covering 1988 through at least 1993. The court denied a motion to dismiss; it did not decide that the alleged fraud had occurred.

One Checkbox Ordered Both Tests

The whistleblower alleged that Corning’s laboratories combined the prostate-specific antigen test and the prostatic acid phosphatase test on their order forms, often labeled PSA/PAP. A physician choosing either test could check only a space that ordered both. The complaint also alleged that the laboratories supplied misleading information encouraging physicians to order the pair when both were not medically necessary.

The allegation links the design of the form to what reached the laboratory. For an employee who knows the requisitions and the instructions given to physicians, the relevant decision happened before a specimen was tested or a claim submitted.

A Coding Debate Did Not Resolve the Allegations

The opinion described a Medicare coding project begun through AdminaStar in 1994. In early 1996, it proposed treating the PSA test as including the PAP test for billing. Public comments disputed that treatment, and AdminaStar removed the pair from the proposed list, allowing payment for both.

Corning relied on that public debate in seeking dismissal. The court explained that the debate had concerned future coding policy, had alleged no wrongdoing and had identified no laboratory as improperly billing the pair. The whistleblower’s allegations therefore survived that dismissal request. The opinion supplied no settlement outcome for this case.

Corning’s Laboratory Business

Corning acquired MetPath in 1982. The business later became part of Corning Clinical Laboratories, whose successor was Quest Diagnostics. Quest’s annual report for fiscal 1996 traces that history.

The Physician’s Choice Starts on the Form

A laboratory requisition shapes the physician’s selection before a specimen reaches the bench. The choices printed on the form, the tests grouped together and the explanation of those groups all matter to whether the physician has chosen the testing the laboratory will bill.

The June 1997 Laboratory Medicine article Model Plan Helps Laboratories Fight Fraud described a federal model compliance plan that addressed precisely this part of the business. It recommended uniform requisitions with space for the physician to document the medical necessity of each test. It also recommended annual notices explaining which individual tests a selected laboratory profile included and how those profiles would be billed to Medicare.

The article also described physician acknowledgments for customized profiles and monitoring of standing orders to confirm their continued validity. Its focus was the ordering relationship as well as the finished claim: what the physician understood, what the laboratory offered and whether an earlier instruction still applied.

The inspector general’s August 1998 guidance for clinical laboratories put the design question plainly. It called for requisitions that ensured an independent medical-necessity decision for each test the laboratory would bill. A form can make that choice visible. A panel can also conceal how many choices have been made for the physician.

Separate Cases Show Why Test Selection Matters

The Justice Department’s February 1997 announcement described allegations that SmithKline Beecham Clinical Laboratories billed for tests that were medically unnecessary, not ordered by a physician or not performed.

A separate whistleblower complaint against Genova Diagnostics alleged that its NutrEval requisition used a single checkbox that prevented physicians from deselecting medically unnecessary tests.

What Evidence Is Needed to Prove Fraud?

We work out with you how the physician’s selection, the tests performed and the claims connect, and what the people responsible knew. Our laboratory fraud work brings your knowledge of health care billing together with the requisitions, profile descriptions and physician communications behind it.

Knowing how a panel was described, what its selection triggered or how concerns were handled gives the documents their meaning.

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

You Know the Ordering Workflow

If you know how a laboratory turned a physician’s selection into tests the patient did not need, speak with our whistleblower experts about the ordering workflow. We build the case with you, bring in laboratory fraud whistleblower lawyers who understand requisitions and medical necessity, and stay beside you through the pursuit of a recovery.