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April 25, 2019

Astellas Pharma US Inc. has agreed to pay $100 million and enter into a corporate integrity agreement to resolve allegations that its use of a purportedly independent foundation to pay copayments on its drug Xtandi for Medicare beneficiaries violated the False Claims Act.  Astellas was alleged to have provided funds to cover copayments for androgen receptor inhibitors (ARIs), although its own drug Xtandi was the only ARI available.  Astellas promoted the existence of the funds as an advantage for Xtandi over competing drugs in an effort to persuade medical providers to prescribe Xtandi. According to the government's allegations, payments to the foundations were not bona fide donations, but instead unlawful kickbacks.   DOJ; USAO Mass

Tagged in: Anti-Kickback and Stark, Drug and DME Pricing, FCA Federal, Pharma Fraud,

April 24, 2019

Two executives of Arriva Medical, LLC, a mail-order diabetic testing supply company acquired by Alere, Inc. in 2011, will pay a total of $1 million to settle claims that they caused Arriva to submit false claims to Medicare by supplying patients with free or no cost home blood glucose meters, waiving patient copayments, and billing for medically unnecessary home blood glucose meters.  USAO MD TN;  2021 settlement with Arriva here

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Lack of Medical Necessity, Medical Devices and DME,

April 9, 2019

A number of telemedicine and durable medical equipment companies, the principals of those companies, and three healthcare providers, were charged with submitting over $1.7 billion in false claims in a scheme to pay unlawful kickbacks and bribes from DME companies in exchange for the referral of Medicare beneficiaries by medical professionals working with fraudulent telemedicine companies for medically unnecessary DME including back, shoulder, wrist and knee braces.  DOJ; USAO MD FL; USAO NJ; USAO SC.

Tagged in: Anti-Kickback and Stark, Criminal Proceedings, Drug and DME Pricing, Lack of Medical Necessity, Provider Fraud,

April 5, 2019

Philip Esformes of Miami Beach, Florida, was found guilty of crimes arising from his role in the submission of over $1.3 billion in fraudulent claims to Medicare and Medicaid.  According to evidence introduced at trial, between 1998 and 2016, Esformes, who owned a network of assisted living and skilled nursing facilities, bribed physicians to admit patients into his facilities, which were in poor condition and unable to provide adequate treatment. Patients often failed to receive appropriate medical services, or received medically unnecessary services.  Esformes was later sentenced to 20 years in prison. USAO SD FL

Tagged in: Anti-Kickback and Stark, Criminal Proceedings, Lack of Medical Necessity, SNF,

April 4, 2019

Alexion Pharmaceuticals Inc. will pay $13 million to resolve allegations that the company violated the False Claims Act by providing funds to a purportedly independent patient assistance program for its drug Soliris in a form that created an improper kickback. Soliris, which, at list price and typical dosages, can cost as much as $500,000/year, was unaffordable to many patients.  While Alexion had a free drug program, it referred Medicare patients to a "Complement-Mediated Disease" fund for copayment assistance; Alexion then billed Medicare for the drugs.  Alexion was the sole donor to the fund, and assistance from the fund was contingent on the patient taking Soliris.   DOJ

Tagged in: Anti-Kickback and Stark, Drug and DME Pricing, FCA Federal, Pharma Fraud,

April 4, 2019

Pharmaceutical company Lundbeck LLC will pay $52.6 million to resolve allegations that the company violated the False Claims Act by providing funds to a purportedly independent patient assistance program for its drug Xenazine, approved for Huntington's Disease, in a form that created an improper kickback. Lundbeck was the sole donor to a fund at a foundation that claimed to provide financial support for patients with Huntington’s Disease. However, Lundbeck also referred Xenazine patients with many other conditions to this foundation, which then paid the Xenazine copays for these off-label uses.  When the foundation determined to stop using its Huntington's fund for non-Huntington's patient, Lundbeck redirected its payments to a different general-purpose fund, with the understanding that fund would use the redirected funds to pay Xenazine copays for these same patients.  Lundbeck is alleged to have denied needy Medicare and ChampVA Xenazine patients access to its free drug program, instead referring them to the patient assistance program, permitting Lundbeck to submit claims to federal healthcare programs.   DOJ

Tagged in: Anti-Kickback and Stark, Drug and DME Pricing, FCA Federal, Off-Label and Unapproved Use, Pharma Fraud,

April 4, 2019

Jazz Pharmaceuticals will pay $57 million to settle allegations that the company violated the False Claims Act by providing funds to a purportedly independent patient assistance program in a form that created an improper kickback.  The funds provided by Jazz were used to cover the copayments for patients to purchase Jazz's drugs Xyrem, a narcolepsy medication, and Prialt, an injectable pain medication.  Jazz referred Medicare patients to the fund, and denied them access to Jazz's free drug program, enabling Jazz to bill Medicare for their purchases. DOJ  

Tagged in: Anti-Kickback and Stark, Drug and DME Pricing, FCA Federal, Medicare, Pharma Fraud,

March 21, 2019

Nonprofit healthcare organization MedStar Health Inc. has agreed to pay $35 million to the United States to settle two qui tam lawsuits alleging violations of the False Claims Act at two of its hospitals in Baltimore. According to the first complaint, filed by three cardiac surgeons, MedStar paid illegal remuneration to MidAtlantic Cardiovascular Associates (MACVA) to induce referrals of Medicare patients. The second complaint, filed by former patients, alleged that while employed by MedStar, former MACVA employee Dr. John Wang engaged in a pattern of performing and billing for medically unnecessary cardiac stent procedures. DOJ

Tagged in: Anti-Kickback and Stark, Healthcare Fraud, Lack of Medical Necessity, Medicare, Provider Fraud, Whistleblower Case, Whistleblower Rewards,

March 11, 2019

Medical device manufacturer Covidien LP will pay $20 million to resolve False Claims Act cases initiated by three whistleblowers alleging that Covidien violated the Anti-Kickback Statute by providing remuneration to healthcare providers in California and Florida.  Covidien markets radiofrequency ablation catheters to providers including vein surgery practices for use in procedures for the treatment of varicose veins and underlying conditions, and allegedly provided its customers with substantial assistance in connection with marketing vein screening and related services in order to increase demand for such services and therefore induce purchases of Covidien's vein ablation products.  Covidien will pay $17.5 million to the United States; $1.5 million to California; and $1 million to Florida.  Two whistleblowers who were sales managers for Covidien, Erin Hayes and Richard Ponder, will share a $3.1 million whistleblower reward.  The settlement also resolves claims by whistleblower Shawnea Howerton, a former employee of one of Covidien's customers.  DOJ; USAO NDCal; FL

Tagged in: Anti-Kickback and Stark, FCA Federal, FCA State, Healthcare Fraud, Medical Devices and DME, Multiple Whistleblowers and First-to-File, Provider Fraud, Whistleblower Case, Whistleblower Rewards,

February 28, 2019

A former employee within the Wayne County Adult Services division of the Michigan Department of Health and Human Services has been charged with defrauding the state's Medicaid program. As an Independent Living Services Specialist, Eliza Yulonda Ijames was responsible for approving Medicaid beneficiaries for home health services. In violation of anti-kickback rules, however, she used her position to refer clients to agencies with which she had an improper financial relationship. AG MI

Tagged in: Anti-Kickback and Stark, Healthcare Fraud, Home Health and Hospice, Medicaid,

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