GlycoMark: Telling Laboratories to Bill Medicare After the Coverage Prohibition

In the GlycoMark Medicare settlement, the test distributor agreed to pay $195,000 to resolve allegations that it encouraged laboratories to bill for its test after Medicare contractors prohibited reimbursement in their jurisdictions. The government alleged that the conduct ran from November 1, 2016 through May 30, 2019. The whistleblower, a marketing consultant, described how that message reached customers: through a sales meeting, product sheets and newsletters. The alleged pitch depended on a billing code that continued to produce payments after coverage stopped.

The Department of Justice announced the civil settlement on March 30, 2023. The allegations covered Medicare and Medicaid claims. Its account identified both direct encouragement to keep billing and promotional material that represented the test as reimbursable without disclosing the prohibition.

GlycoMark Medicare Coverage Changed, but the Code Remained

GlycoMark Medicare coverage changed when a Medicare contractor prohibited reimbursement for the test, effective October 17, 2016. Before that change, the test had been eligible for reimbursement under CPT 84378, a code used for a variety of blood-sugar tests.

GlycoMark distributed a blood test used to detect hyperglycemia and hyperglycemic excursions, or episodes of high blood sugar. The company promoted it as helping identify patients who might benefit from closer diabetes management. The assay measures the blood level of 1,5-anhydroglucitol.

Palmetto GBA’s Local Coverage Determination L36761, titled GlycoMark Testing for Glycemic Control, explains the clinical-utility problem. Its evidence review describes studies correlating the marker with other measures of blood sugar, but finds inadequate evidence that using it to manage diabetes improves patient outcomes. The policy concludes that the testing is not reasonable and necessary for diabetes management or prevention of diabetic complications.

GlycoMark’s alleged sales message carried an assurance of payment into a market where the contractor had rejected the clinical justification for that payment.

CGS Administrators adopted its own GlycoMark noncoverage policy, effective March 6, 2017, for Kentucky and Ohio. The complaint’s account of a later customer meeting places Cleveland Heart Laboratory inside the CGS jurisdiction, after its prohibition had taken effect.

The Distributor’s Pitch Reached the Laboratory’s Claim

The government alleged that GlycoMark caused laboratories to submit claims by telling them to keep using the same billing code. The distributor supplied the test and the reimbursement message. The laboratory sent the bill.

The whistleblower’s complaint alleged that the company believed Medicare could not distinguish GlycoMark testing from other reimbursable blood-sugar tests submitted under CPT 84378. According to that account, payments kept arriving in jurisdictions where the test was no longer covered. The company allegedly treated the claims system’s failure to distinguish the tests as a reason to continue billing.

The complaint describes a meeting with Cleveland Heart Laboratory in which GlycoMark’s national sales manager allegedly made the point bluntly:

The alleged sales pitch turned Medicare’s billing blind spot into a selling point, with taxpayers footing the bill for tests the program had stopped covering. The complaint alleges that the company knew of the prohibition and that the sales manager traced his instructions to GlycoMark’s president and director of scientific affairs.

The Alleged Removal of the Reimbursement Disclaimer

GlycoMark allegedly spread the same reimbursement message through marketing materials, including newsletters directed to healthcare professionals. The complaint describes an internal discussion of the problem before the later publications went out.

In January 2017, according to the complaint, GlycoMark prepared product sheets to carry both its own branding and its laboratory customers’ branding. The laboratories would use the sheets to market the test to physicians. An executive questioned whether the reimbursement wording needed to change because of the coverage decision. The company obtained a recommended disclaimer about the limits of its reimbursement information and the billing provider’s responsibility for submitting claims consistent with insurer requirements.

The complaint says the product sheets published that month included the disclaimer. It then alleges that senior management instructed the marketing consultant to publish literature, newsletters and email messages describing Medicare reimbursement while excluding that disclaimer.

The February 2018 newsletter carried this statement, reproduced in the complaint:

According to the complaint, the newsletter mentioned neither the noncoverage decisions nor the recommended disclaimer. The government later alleged that GlycoMark distributed materials saying “reimbursed by Medicare” and displaying the code without disclosing that reimbursement was prohibited.

When a lab distributor tells customers Medicare reimburses a noncovered assay, the sales message can reach both the laboratory and the physician ordering the test. The complaint’s sequence makes the alleged choice visible. A limitation had been considered, written and used. Later materials allegedly left it out while retaining the promise of reimbursement.

What Evidence Is Needed to Prove Fraud?

In GlycoMark, the complaint pointed to internal correspondence, a customer meeting and successive versions of marketing material. Connecting records like these to laboratory claims is work we do with you.

The knowledge allegation began before the prohibition took effect. The complaint describes a scientific-affairs memorandum anticipating the loss of reimbursement and a letter from the president to the board about the expected coverage decision. Later, it alleges, the board was consulted about the prohibitions and directed continued marketing as though Medicare reimbursement remained available in all jurisdictions.

The early product sheets and later newsletters show why the publication history matters. Their wording can reveal who raised the coverage problem, how the business first responded, and what management subsequently told the people writing for customers. A marketing employee can see that sequence from inside the company. A laboratory billing employee can see what the reimbursement message became when a claim went out.

Our work is to connect those views: what the supplier knew and represented, what the laboratory performed and billed, and which coverage policy applied. In this case, the whistleblower’s marketing role gave access to decisions that a claim form alone would never explain.

A Civil Settlement From a Whistleblower Case

A whistleblower started this False Claims Act case, and GlycoMark agreed to pay to end it. The Department of Health and Human Services Office of Inspector General conducted the investigation.

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

Reimbursement Information Is Part of Selling a Test

Laboratory marketing carries information that can shape both the order and the bill. The 1997 Laboratory Medicine article Model Plan Helps Laboratories Fight Fraud described federal guidance encouraging laboratories to explain medical-necessity policy to ordering physicians, identify the codes used for test profiles and describe how those profiles would be billed. The article put communication with the ordering physician inside the laboratory’s fraud-prevention work.

The GlycoMark allegations show that communication running through a supplier as well. The laboratory was the customer for the assay and a channel for the reimbursement message. Marketing drafts and sales instructions therefore belong beside the laboratory’s billing records when examining how the government came to receive a claim.

The same reach from biller to supplier appeared in the separate Nichols Institute Diagnostics case. The government’s civil allegation was that test kits caused medical providers to submit claims for unnecessary treatment. GlycoMark’s alleged reimbursement pitch followed that same commercial chain from the product seller to the government payer.

You Saw the Reimbursement Pitch

If you worked on test marketing, sales or laboratory billing and saw a coverage prohibition disappear from the message to customers, speak with our whistleblower experts. We build the case with you around the decisions behind those claims, bring in clinical-laboratory whistleblower lawyers who know Medicare reimbursement disputes, and stay beside you through the case.