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Anti-Kickback and Stark

This archive displays posts tagged as relevant to the Anti-Kickback Statute and Stark Law.

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December 21, 2023

Ultragenyx Pharmaceutical, Inc., maker of Crysvita, will pay $6 million for violating the False Claims Act. Crysvita is prescribed to treat a rare inherited blood disorder, which may require a genetic test to definitively diagnose. To induce purchases and referrals, Ultragenyx paid a laboratory to conduct genetic tests at no cost to healthcare providers or patients, and then provide the results reports to Ultragenyx. Ultragenyx then used the positive test results reports to target healthcare providers for Crysvita sales. Internally, Ultragenyx referred to this kickback scheme as their "sponsored" testing program. The program was exposed via a qui tam whistleblower, who will receive $1.07 million of the $6.7 million recovery. DOJ

December 19, 2023

Indiana-based Community Health Network Inc. has agreed to pay $345 million to resolve claims by its former CFO and COO Thomas Fischer, which alleged the healthcare system submitted claims to Medicare that were tainted by violations of the Stark Law.  In order to capture physicians’ downstream referrals, Community paid physicians salaries that were sometimes double market rate, and awarded them bonuses based on the number of referrals.  Community then submitted claims resulting from these referrals for reimbursement.  DOJ

$45.6 Million Settlement in False Claims Act Case Against Nursing Facility Defendants

Posted  11/17/23
Nurse Holding Clipboard in Front of Nursing Patient
The DOJ recently announced another settlement of a False Claims Act case against skilled nursing facilities (SNFs).  This time, it was a $45.6 million settlement of a False Claims Act case that the government brought against six SNFs; a management company called Paksn Inc.; and Prema Thekkek, the owner.  The six SNFs do business as (i) Bay Point Healthcare Center (Kayal Inc.); (ii) Gateway Care & Rehabilitation...

October 18, 2023

The president of a California-based medical technology company has been sentenced to 8 years in prison and ordered to pay $24 million in restitution in the first COVID-related criminal securities fraud case charged by DOJ and the first COVID-related criminal healthcare fraud case brought to trial.  Among many things, Mark Schena of Arrayit Corporation was found to have taken advantage of the pandemic by claiming he and his company had developed a technology to test for just about any disease, including COVID, using a single drop of blood.  In doing so, Schena and Arrayit lied to investors to give them a false sense of credibility, paid illegal kickbacks to marketers to run deceptive plans about the accuracy of its tests, and submitted false claims to Medicare and private insurers for medically unnecessary allergy testing.  DOJ

October 10, 2023

Mobile cardiac PET scan provider Cardiac Imaging Inc. (CII), and its founder and owner Sam Kancherlapalli, have agreed to pay over $75 million and over $10 million, respectively, to resolve a qui tam case by former billing manager Lynda Pinto, which alleged the company, Kancherlapalli, and part-owner Richard Nassenstein defrauded Medicare.  In violation of the Anti-Kickback Statute, Stark Law, and False Claims Act, CII and Kancherlapalli allegedly paid kickbacks to referring cardiologists in the form of fees, ostensibly for supervising PET scans, that were far above fair market value.  The alleged misconduct occurred over a ten year period.  DOJ

October 2, 2023

BioTek reMEDys Inc. and its CEO, Chaitanya Gadde, have agreed to pay $20 million to resolve allegations of providing illegal kickbacks to patients and physicians, in violation of the False Claims Act and Anti-Kickback Statute.  Former employees Shantae Wyatt and Latoya Sparrow alleged in a qui tam suit that the specialty pharmacy induced patients to purchase drugs by routinely waiving mandatory copays, and induced physicians to make referrals by providing dinners, gifts, and free administrative or clinical support services.  One physician in particular who received kickbacks, Dr. David Tabby, has paid $480,000 to resolve allegations against him.  Wyatt and Sparrow will receive over $4 million from the settlement with BioTek and Gadde, and over $91,000 from the settlement with Tabby.  DOJ

October 2, 2023

Genomic Health, Inc. (GHI), a wholly-owned subsidiary of Exact Sciences Corporation that provides clinical diagnostic tests, has agreed to pay $32.5 million to resolve two separate qui tam suits alleging violations of the False Claims Act and Anti-Kickback Statute in connection with lab tests for cancer patients.  GHI allegedly evaded Medicare’s 14-Day Rule—which prohibits labs from separately billing for the same covered tests within 14 days of a patient’s discharge from a hospital—by canceling and reordering tests so they fell within appropriate time frames, seeking reimbursement directly from Medicare, and writing off unpaid lab fees owed by hospitals.  As a result of this settlement, the whistleblowers in the case will receive over $5.5 million.  DOJ

Catch of the Week: Gramercy Cardiac Diagnostic Services

Posted  09/26/23
businessmen shaking hands and other placing money in others pocket
This week's Department of Justice (DOJ) Catch of the Week goes to Gramercy Cardiac Diagnostic Services and its owner Klaus Peter Rentrop.  Gramercy provides cardiac diagnostic imaging services, previously operating out of four offices in New York City.  On Monday (September 18), the DOJ announced Rentrop and Gramercy will pay $6.5 million for violating the False Claims Act and Anti-Kickback Statute through their...

September 13, 2023

Texas-based Oliver Street Dermatology Management LLC, which manages dermatology practices, surgical centers, and pathology labs across the country, has agreed to pay $8.9 million to resolve self-reported violations of the Anti-Kickback Statute, Stark Law, and False Claims Act.  The company revealed in 2021 that some of its former senior managers had fraudulently increased the purchase price of 11 dermatology practices acquired between 2013 and 2018 in exchange for referrals.  Claims arising from those referrals were found to have been submitted to Medicare.  USAO NDTX

August 31, 2023

Watermark Retirement Communities LLC, which manages 79 retirement homes across the country, has agreed to pay $4.25 million to settle claims of violating the Anti-Kickback Statute and False Claims Act.  According to a lawsuit launched by David Freeman, the former director of strategic growth for a nationwide home health agency (HHA), between 2014 and 2020, Watermark solicited and received kickbacks from the HHA in exchange for referrals of Medicare beneficiaries from 8 of its retirement facilities in 5 states, including Arizona, Connecticut, Delaware, Florida, and Pennsylvania.  Watermark then caused false claims to be submitted in connection with those referrals.  DOJ
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