Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Self-Disclosing Saves Kentucky Lab Over $1 Million in False Claims Settlement

Case: A Kentucky-based lab that made heroic efforts to step up its COVID-19 testing early in the pandemic has agreed to shell $1.25 million for falsely billing Medicare, Medicaid, TRICARE and CHAMPVA for urine drug tests between 2016 and 2018. The U.S. Attorney claimed that Bluewater Toxicology:

  • Submitted claims for definitive urine drug tests of 22 or more drug classes even though it tested for a lower number of classes to secure higher reimbursement;
  • Submitted certain claims without sufficient documentation showing the treating physician’s intent to order the test; and
  • Billed for specimen validity testing (SVT), a procedure to verify that a urine sample for drug testing hasn’t been diluted which isn’t covered by Medicare and other federal health programs.

Significance: Even though $1.25 million is a lot of money, the settlement price tag could have been twice as high had the lab not come forward to self-disclose and thereby secure a 1.5 monetary loss rate rather than the triple damages provided for by the False Claims Act.

Blue Cross and Blue Shield Sues Lab for COVID-19 Test Price Gouging

Case: Blue Cross and Blue Shield of Kansas City is suing GS Labs for COVID-19 test price gouging, contending that the national testing facility inflated its cash prices and performed medically unnecessary tests on out-of-network members. The $9.2 million federal lawsuit accuses GS Labs of “engaging in an abusive scheme to exploit the COVID-19 pandemic by duping health insurers into paying thousands of COVID-19 diagnostic testing claims at grossly inflated rates.” BCBS claims that GS Labs charged it $380 for a COVID-19 antigen test, roughly 10 times what Medicare reimburses for the test and up to $979 for a PCR test.

Significance: Insurers and labs have been waging PR war against each other almost from the moment the federal government mandated that payors cover COVID-19 tests without charging copays, deductibles or other out-of-pocket expenses. Labs have claimed that payors aren’t obeying the mandate; insurers have accused labs of price gouging. But this is the first time the conflict has festered into actual litigation. However, this is not the first time that GS Labs’ test prices have come under question. Last December, the Kansas Insurance Department began investigating a local facility owned by GS Labs for charging $1,000 for tests. GS Labs has yet to comment on these allegations.

Georgia Lab Owner Must Stand Criminal Trial for CGx Kickback and Billing Scam

Case: In 2019, the feds indicted the owner of a Georgia lab for allegedly paying kickbacks to patient recruiters to engage in telemarketing campaigns and health fairs in an effort to drum up referrals of Medicare patients for medically unnecessary cancer genomic (CGx) BRCA tests and then billing Medicare for the tests. The owner asked the Florida federal district court to toss the indictment, claiming that:

  • The payments to recruiters weren’t kickbacks but legitimate payments to “patient navigators” under the Affordable Care Act;
  • The US Preventive Services Task Force recommends BRCA CGx testing for certain cases and Medicare is legally required to cover any screening tests the Task Force recommends; and
  • Labs don’t have an independent duty to verify that ordered tests are medically necessary.

Not surprisingly, the court upheld the indictment.

Significance: Although the court suggested that the lab owner’s legal theories were way off base, especially the medically necessary argument, the refusal to dismiss the indictment was also based on procedural grounds to the extent that the arguments raised questions of fact that would have to be determined at trial [United States v. Patel, 2021 U.S. Dist. LEXIS 115925, 2021 WL 2550477

West Virginia Clinic Becomes Most Recent Provider Fined for HIPAA Right of Access Violation

Case: Instead of the required 60 days, it took a West Virginia diabetes clinic two years to provide access to a minor child patient’s mother access to his medical records. In addition to $5,000 to settle a potential HIPAA Privacy Rule violation, the clinic had to agree to implement a corrective action plan providing for two years of Office for Civil Rights (OCR) monitoring.

Significance: This is the 19th fine the OCR has handed out since it launched its HIPAA Right of Access Initiative in April 2019 targeting providers for not granting individuals’ access to their own protected health information. Although the initiative remains ongoing, the pace of fines has slowed considerably under the Biden administration. The West Virigina settlement represents the second lowest fine. The highest fine was $200,000. Here’s a Scorecard of all the fines issued so far.

OCR Right of Access Initiative Settlements Scorecard (as of July 26, 2021)

Provider Settlement Amount* Allegations
Banner Health ACE 200000 OCR cites two occasions in which Phoenix-based not-for-profit health system took about 6 months to provide patients their requested PHI
St. Joseph’s Hospital and Medical Center 160000 Phoenix hospital refused to provide PHI to patient’s mother even though she was his legal representative
NY Spine Medicine 100000 Neurology practice refuses patient’s multiple requests for copies of specific diagnostic films
Bayfront Hospital 85000 Florida hospital didn’t provide expectant mother timely access to the PHI of her unborn child
Korunda Medical 85000 After first refusing to provide it at all, Florida primary care and interventional pain management services provider sent patient’s PHI to third party in the wrong format and charged him excessive fees
Renown Health, P.C. 75000 Nevada private, not-for-profit health system didn’t timely honor patient’s request to transfer her EHR and billing records to a third party
Sharp Rees-Stealy Medical Centers 70000 California hospital and healthcare network didn’t timely honor request to transfer patient’s EHR to a third party
Beth Israel Lahey Health Behavioral Services 70000 Massachusetts provider ignored request of personal representative seeking access to her father’s PHI
Arbour Hospital 65000 Massachusetts mental health services provider kept patient waiting 5 months before granting access to his PHI
University of Cincinnati Medical Center, LLC 65000 Ohio academic medical center failed to respond to patient’s request to send an electronic copy of her medical records maintained in its electronic health record EHR to her lawyers
Housing Works Inc. 38000 New York City non-profit services provider refused patient’s request for a copy of his medical records
Peter Wrobel, M.D., P.C., dba Elite Primary Care 36000 Georgia primary care practice failed to provide patient access to his medical records
Village Plastic Surgery 30000 New Jersey practice failed to provide patient timely access to his medical records
Riverside Psychiatric Medical Group 25000 California medical group didn’t provide patient copy of her medical records despite repeated requests and OCR intervention
Dr. Rajendra Bhayani 15000 NY physician didn’t provide patient her medical records even after OCR intervened and closed the complaint
All Inclusive Medical Services, Inc. 15000 California multi-specialty family medicine clinic refused patient’s requests to inspect and receive a copy of her records
Wise Psychiatry, PC 10000 Colorado psychiatric firm refused to provide personal representative access to his minor son’s medical record
Diabetes, Endocrinology & Lipidology Center, Inc. 5000 West Virginia diabetes clinic made the mother of a minor patient wait nearly 2 years for access to his medical records
King MD 3500 Virginia psychiatric practice didn’t provide patient access to her medical records even after OCR intervened, provided technical assistance and closed the complaint
*In addition to the monetary settlement, each accused provider had to agree to implement a corrective action plan and allow the OCR to conduct close monitoring for one to two years
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