Exclusion screening for clinical & diagnostic labs

Genetic-testing cases put labs at the center of fraud enforcement

Few corners of healthcare draw as much sustained federal attention as the laboratory business. Prosecutors return to the same playbook again and again: a lab pays "marketers" to collect Medicare beneficiaries' DNA swabs and insurance details, then bills for cancer-risk or pharmacogenetic panels that almost no treating physician reviewed or used. One scheme alone ran roughly $522 million in false genetic-testing claims, with Medicare, Medicaid, and private insurers paying about $84 million before two defendants were sentenced to prison.

Genetics is only the headline. Respiratory pathogen panels, allergy screens, urine drug testing, and pandemic-era over-ordering have all produced charges. Mark Schena, president of Arrayit, was convicted after his lab paid recruiters and physicians to run a 120-allergen panel on patients regardless of medical need and bundled it with COVID-19 testing; the Ninth Circuit upheld that conviction in 2025. What links these cases is the referral relationship and the marketing money attached to it, which is precisely where exclusion and kickback exposure live.

EKRA rewrote the kickback rules for lab marketing

Labs sit under a stricter kickback regime than many operators assume. The Anti-Kickback Statute reaches arrangements tied to federal program business. The Eliminating Kickbacks in Recovery Act (EKRA), codified at 18 U.S.C. § 220 in 2018, reaches further: it is an all-payer law, so paying a percentage-based commission to a marketer who steers lab referrals can be a federal crime even when the patient carries commercial insurance. Each violation can bring fines up to $200,000 and ten years in prison. The Schena ruling confirmed that EKRA applies well beyond the addiction-treatment context it was named for, and laboratory marketing is squarely in scope.

This reshapes who belongs on your screening roster. The people at the heart of lab cases are rarely on your W-2 payroll. They are independent sales reps, marketing vendors, account managers, and the ordering physicians whose requisitions feed your analyzers. Should any of them appear on an exclusion list while touching claims you bill, the kickback problem and the exclusion problem reinforce each other. Keeping marketers and contractors under continuous screening is not excess caution; it tracks how these prosecutions are actually built.

Your requisition is the blind spot: screen who orders, not just who you pay

A lab's exclusion exposure travels along the requisition. You bill Medicare Part B and state Medicaid for tests that outside physicians order, and federal programs will not pay for any item or service connected to an excluded person, whether that person furnished it directly or ordered it. An excluded ordering physician can quietly convert a clean specimen into a non-payable claim, and nobody at the bench would see it happen.

Provider Signals lets you cover the whole chain from one roster:

• Your own staff: pathologists, lab directors, medical technologists, phlebotomists, couriers, and the billing and IT contractors who support the claims you submit.
• Ordering and referring providers: load the physicians and practices whose requisitions you process, so an excluded orderer is flagged before it taints a month of billing.
• Marketing and sales networks: the independent reps and vendor entities that EKRA and Anti-Kickback cases revolve around.
• Audit-ready evidence: a dated, exportable log of every screen for CLIA surveyors, MAC audits, payer credentialing, and your compliance file.

What one excluded name costs a high-volume lab

An OIG exclusion is comprehensive. No federal health program will pay for anything an excluded individual or entity furnishes, orders, or prescribes. For a lab pushing thousands of claims a month, the "orders" piece is where a single miss multiplies. The penalty for employing or contracting with an excluded person reaches $20,000 per item or service under 42 C.F.R. § 1003.210 (a base figure before annual inflation adjustment), and the exposure compounds:

• A per-item penalty on every claim the excluded person touched, which at laboratory claim volumes climbs fast.
• An assessment of up to three times the amount claimed.
• Repayment of every affected reimbursement, with potential False Claims Act liability stacked on top.

Because so much testing revenue is Medicaid, state lists carry as much weight as the federal LEIE. UTC Laboratories is the cautionary version: the lab and its principals paid $42.6 million in 2019 over pharmacogenetic-testing kickbacks, and the company accepted a 25-year exclusion from federal health programs. Reinstatement on the federal list does not erase a state sanction, so all-state Medicaid coverage belongs in your baseline rather than a premium tier. Provider Signals includes every state list on every plan.

Where Provider Signals beats the enterprise screening suites

Legacy exclusion-screening vendors are built and priced for hospital systems, often $15,000 to $200,000 a year, and many still treat all-state Medicaid coverage as a paid extra. Provider Signals delivers continuous, all-source monitoring on a self-serve plan scaled to your roster.

The OIG expects screening at hire and again every month, since the LEIE refreshes monthly. Provider Signals runs continuously and alerts you the instant a name matches, so your roster stays current between hires. See how it works on the exclusion screening overview, compare other segments on the industry hub, or size your list on the pricing page.

How we match your roster

Exclusion screening is only as good as its matching. We match each person or entity against every source using the full identifier set together — NPI, first name, last or organization name, city, state, and ZIP — never one field alone. NPI alone misses records (the OIG LEIE and many lists don’t carry an NPI for every entry); a name or a location alone produces false matches on common names. When a source record has no NPI, we fall back to name plus location.

Because accuracy depends on your input, provide complete, correct details for every roster entry. When more than one possible match is found, we show you all candidates with their source records so you can confirm, select, or merge — we never auto-flag anyone as excluded. Always verify a match against the primary source before taking any action.

Frequently asked questions