Policy and Politics News

Kidney community advocates applauded passage of the 2-year Congressional budget bill that passed late last week. The bill included several provisions that benefit patients and providers.

With the supply for IV saline making a gradual recovery after manufacturing plants in Puerto Rico battered by Hurricane Maria return to full capacity, a new concern is the shortage of heparin for the U.S. market. The anticoagulant, used heavily by hospitals for multiple applications and by dialysis facilities, is already on the FDA’s list of drug shortages.

AMAG Pharmaceuticals Inc. has received FDA approval to broaden the existing label for its iron drug Feraheme to include all eligible adults with iron deficiency anemia. The drug is already indicated for use in patients with chronic kidney disease and end-stage renal disease.

Fresenius Medical Care North America has agreed to pay $3.5 million to the HHS Office for Civil Rights and to adopt a comprehensive corrective action plan after acknowledging that it had security breaches of patient information at five dialysis facilities between February 2012 and July 2012.

A $3.5 million national media campaign funded by the Service Employees International Union-United Healthcare Workers West launched on Feb. 5, featuring ads on national cable networks, consumer health websites, social media and in newspapers.

The FDA has granted Protalix BioTherapeutics Inc., an Israel-based company, fast track status for PRX-102, the company’s infusion treatment for Fabry disease.

American Renal Associates Holdings Inc. announced Feb. 1 that it had agreed to pay $4 million to settle a class action lawsuit filed 2 years ago by shareholders about what they labelled “false and/or misleading statements” released by ARA about the provider’s financial health, as well as failing to disclose facts about company business practices.

Two years of input from the kidney care industry have reshaped the five-star rating system for dialysis care, reducing its initial controversial impact, acknowledging more four- and five-star facilities, and making it a useful tool for patients looking to evaluate the quality of care at clinics throughout the United States. However, authors of a recently published review noted that the rating system needs continuous monitoring to ensure consumers are getting updated, quality data.

While the concept of a universal health care system for the United States has been around for many years, the debate intensified during the 2016 presidential race. The Medicare for All Act was introduced in 2017 by Sen. Bernie Sanders (I-Vt.) in an effort to expand health care for everyone. California legislators also recently debated the merits of universal health care.

Every day, patients with late-stage chronic kidney disease or end-stage renal disease and their families must make important decisions about issues that could impact their life with kidney failure (Figure). These critical decisions are best achieved through deliberation and discussions with diverse groups, including the health care team, the patient and the patient’s family. Managing patients’ choices requires education from the health care team to help patients achieve informed choice.