U.S. dialysis centers are paying nearly double what they’re used to for the blood-thinning drug heparin because of recalls and the contamination of raw ingredients in China, according to a report from USA Today.

Click HERE to read the story.

Dialysis providers Renal Advantage and DaVita told USA Today that prices for heparin have risen twice since mid-April. Both organizations get their heparin from APP Pharmaceuticals, which is now the largest U.S. supplier of heparin since previous market-leader Baxter had to recall its product after hundreds of adverse reactions were reported across the country, and a contaminant was found in the supply chain from China.

The contamination—which may have caused up to 81 deaths—has been found in 11 countries and has been linked to 12 Chinese sources, according to the U.S. Food and Drug Administration.

APP has tripled its heparin production in the last three months, according to the USA Today article. However, the cost of crude China-based heparin has increased 500 percent since early 2007. These costs have risen because of a more controlled supply of Chinese pigs, from which heparin is derived as well as additional FDA-mandated testing to ensure a safe heparin supply.

APP sources told USA Today that it has absorbed some of the increased costs of raw materials, but that the price increases are necessary to “stay in business.”

Unfortunately, this trickle-down cost increase will have to be absorbed by dialysis providers as Medicare reimbursement rates are fixed and don’t adjust for these types of fluctuations in drug costs.

The affects of the FDA’s inability to properly monitor overseas facilities is glaring and the costs are real—not only in dollars but also patients’ lives. It’s yet another example of how the upfront investment into prevention could offset larger costs down the road from mistakes.

So why does the United States have to receive its raw heparin from the intestines of Chinese pigs? Click HERE to see a Food and Agriculture Organization of the United Nations breakdown of the world’s pig population.

Sure, China’s pig population of more than 466 million dwarfs the rest of the world’s number, but the United States has the second largest population at more than 60 million pigs. There’s the argument that companies can access cheaper labor costs in China, but that country’s labor costs are starting to rise. Add shipping costs and now increased costs from the FDA for testing, and it all has to make one wonder why we just don’t bring production home.

Last month, the Centers for Medicare & Medicaid Services updated the dialysis facility conditions for coverage for the first time since 1976. The rules set the minimum requirements dialysis centers must meet in order to operate and be Medicare certified.

Given the complicated nature of running a dialysis clinic, there are sure to be many questions. And CMS has answers—starting May 12.

Anyone in the renal community with questions about the new conditions can email CMS at ESRD_Final_Rule_Rollout@cms.hhs.gov.

In an email blast today, CMS said to only submit questions that pertain to the new conditions. CMS added that its answers will come on a rolling basis. “Our goal is to be as timely as possible with responses,” CMS wrote in the email, “but we cannot commit to a prescribed schedule.”

Baxter International is alleging that Fresenius Medical Care has violated four additional Baxter patents in the design of the Fresenius 2008K dialysis machine, according to court documents filed April 28.

The new lawsuit comes on the heels of an April 4 decision by a California federal judge to bar Fresenius from making, using or selling its 2008K machine in the United States after a previous patent infringement decision was upheld.

The patents in question, according to the filing, include technology surrounding the touch-screen interface on the dialysis machine, dialysate flow measurement, and dialysate delivery, among other things.

The lawsuit was filed with the U.S. District Court for the Northern District of Illinois. Click HERE to read the 210-page court filing.