Knowledge Base Article

How do you go from laboratory technologist to compliance professional? You see it often because the detail oriented mind of laboratorians fits well into the myriad details of compliance requirements. For me, I happened to be the manager of a hospital outpatient laboratory at the time the Office of Inspector General (OIG) released the Compliance Program Guidance for Clinical Laboratories. In short order, it fell upon my shoulders to “do something” about this Compliance Guidance. The OIG guidance was in part a response to recent concerns about laboratory billing practices. A prominent national laboratory had at the time been under scrutiny for adding one more laboratory test to a large, frequently ordered lab profile that consisted of a significant number of different lab tests. According to the government, this caused physicians to unknowingly (or at least without careful consideration of medical need) order “medically unnecessary” lab tests.

I often refer to this as “the original compliance sin” and the issue of medical necessity is still a major concern for compliance, and not only for laboratory tests. Medical necessity now involves various types of medical services – from ambulances, to cardiology procedures, to high-cost drugs, to joint replacements, to many other services and even back to laboratory tests. Two recent enforcement actions posted on the OIG’s website are related to medically unnecessary laboratory pathology services.

The first case involves Poplar Healthcare located in Memphis, Tennessee, which paid nearly $900,000 to resolve False Claims Act allegations. According to the Department of Justice (DOJ) Press Release, “The government alleges that Poplar, directly and through a subsidiary known as GI Pathology, promoted and billed the government for diagnostic tests that the government contends were not medically necessary.” Poplar conducted an extensive, multi-year promotional campaign promoting the use of a special pathology stain they claimed could definitively diagnose “mast cell enterocolitis.” The government contended Poplar’s claims about the stain were not supported by scientific evidence and were not consistent with FDA approval requirements.

A similar case against Piedmont Pathology in Hickory, N.C also involves the medically unnecessary use of pathology stains. In this case, the pathology laboratory was performing and billing for special stains on certain gastric biopsies. The special stains were performed before a pathologist reviewed routinely stained specimens to determine if there was a medical need for the additional special stains. Piedmont Pathology has agreed to pay the United States $601,000 to settle allegations that it violated the False Claims Act by submitting false claims to Medicare and Medicaid for medically unnecessary procedures. The DOJ press release provides further details.

Another similarity between these two cases is that both were “whistleblower” cases where a private citizen can bring suit on behalf of the government for false claims under provisions of the False Claim Act. The government can decide to take over the case and the whistleblower shares in any monetary recovery. In these cases, the relator’s share was $205,841 and approximately $120,200, respectively.

There are important take-aways for all providers from these settlements:

• The government is serious about the medical necessity of services (for all types of healthcare services);
• No service is too big or too small for government attention;
• Be careful what a vendor tries to sell you;
• Verify the medical need for the services you provide; and
• Watch out for the whistleblowers!