9 December 2022

Benesch Healthcare+ Dialysis & Nephrology Digest No. 35

Benesch Friedlander Coplan & Aronoff


Benesch Friedlander Coplan & Aronoff
The DOJ filed an Amended Intervenor Complaint in Aug. alleging between 2012 and 2018, Fresenius Medical Care's business unit, Azura Vascular Care, was engaged in the following acts in contravention...
United States Food, Drugs, Healthcare, Life Sciences
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Nephrology and Dialysis

Benesch: AKS claims against Azura dropped; FCA allegations to continue with DOJ intervention

The DOJ filed an Amended Intervenor Complaint in Aug. alleging between 2012 and 2018, Fresenius Medical Care's business unit, Azura Vascular Care, was engaged in the following acts in contravention of the federal False Claims Act (FCA):

  • Repeatedly performed and billed Medicare, Medicaid and other government healthcare programs for medically unnecessary vascular access procedures; and
  • Falsified referrals to make it appear that patients' nephrologists referred the patients for these unnecessary procedures.

The DOJ declined to join a complaint the defendants violated the federal Anti-Kickback Statute and these charges were ultimately dropped. Joining the DOJ in the FCA case are the states of FL, GA, NJ and NY. The District Court for the Eastern District of New York granted Azura time to answer the amended complaint and no deadline for the defendant's response was specified.

SOURCE: Mondaq

TX legislature passes bill designed to keep dialysis clinics operating during weather-related disasters

The state Senate passed a bill meant to avoid disruptions in services at dialysis centers due weather events that affect water and electricity supplies. The legislation requires dialysis centers, hospitals and nursing homes be prioritized for electricity and water restoration and to have 24 hours' worth of power and potable water in reserve. However, facilities can contract with third parties for water delivery and electric generators during shutdowns. In TX's lower house, a bill is being formulated for the 2023 session which would require dialysis centers to purchase on-site generators. A version of that bill was defeated in the House this year and both DaVita and Fresenius indicated they're not in favor of that provision. Although the Senate bill stems from the Deep Freeze that knocked out the power grid in TX for two weeks in 2021, the language in the legislation isn't meant to cover a situation as severe as that.


CA voters overwhelmingly reject Prop 29; would've altered staffing at dialysis clinics

Calif. voters said "no" to a ballot proposition whereby a doctor, nurse practitioner or physician's assistant would need to be present during treatment at the state's 600 outpatient dialysis facilities. Sixty-eight percent of the ballots were against the measure, with the "no" campaign receiving $86.4 million in contributions from DaVita and Fresenius. The "yes" campaign was led once again by unions that represent healthcare workers, who vow to continue the fight despite being roundly defeated for the third time.

SOURCE: The Associated Press

Thirteen Fresenius, Satellite dialysis centers in CA targeted by union drives

Workers at eight Fresenius facilities and five dialysis centers owned by Satellite Healthcare in the state filed for elections to join the SEIU-UHW. The nearly 300 employees, nurses, patient care technicians, hemodialysis technicians, social workers, dietitians, biomedical technicians and administrative staff, want to improve working conditions, staffing, patient care and wages.


Fresenius CEO vows to cuts costs to counter profit drops

Michael Sen was heading the company's pharmaceutical operations when he became CEO in Oct. Two of Fresenius' business groups, including its dialysis unit, Fresenius Medical Care (FMC), are underperforming in what the company is calling a "challenging overall economic environment." FMC is burdened by inflationary cost increases, staff shortages (particularly in the U.S.), supply chain issues and soaring electricity prices. Sen indicates that a reset is inevitable to improve returns and already outlined the possibility of selling off some of the company's assets.

SOURCE: Fierce Pharma

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