Policy and Politics News

The U.S. Food & Drug Administration (FDA) has approved the New Drug Application for Rockwell Medical Inc.’s Triferic Powder Packet for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.

Editor’s note: Since this article was published, the authors have clarified DaVita Kidney Care’s central venous catheter rate, based on Fistula First Breakthrough Initiative data.  The article originally stated that the provider’s overall CVC rate is 6.5%. That percentage represents catheters in place among DaVita patients for < 90 days.  For catheters in place greater than or equal to 90 days, the rate is 9.3%, and for those with other forms of access in addition to catheters the rate is 0.7%. Thus, the overall catheter rate for DaVita Kidney Care’s patient population is 16.5%.

Insurance carriers in at least 34 states have begun to reject insurance premium payments from the American Kidney Fund (AKF) and many other health nonprofits on behalf of enrollees with chronic diseases, according to patient advocacy groups. AKF and others in the kidney community are asking the Centers for Medicare & Medicaid Services to issue rulemaking that would allow nonprofits to continue making so-called “third-party payments” to help individuals who cannot afford health coverage.

The China Food and Drug Administration has accepted Rockwell Medical Inc.’s product submission for Triferic and has begun the review process for regulatory approval of the drug as an iron maintenance therapy in patients with chronic kidney disease on hemodialysis. The drug approval process in China requires the company to file a clinical trial application, which is based on the same information that was included in the new drug application Rockwell filed with the U.S. Food and Drug Administration.

Schmidt

On Feb. 25 Congress introduced the Living Donor Protection Act of 2016. The bill is designed to protect the rights of living donors and remove barriers to living organ donation. The bipartisan bill aims to do the following:

President Barack Obama's budget proposal, released Feb. 9, includes a 200% increase to the withhold for the End-Stage Renal Disease Networks, according to an alert from the National Renal Administrators Association (NRAA). The withhold is deducted from the End-Stage Renal Disease Prospective Payment System per treatment payment, and has not been increased since 1986.

“Is the QIP applicable to nephrologists?”

The Centers for Medicare & Medicaid Services (CMS) will add three new measures to Dialysis Facility Compare in October 2016. After review of  public comments, CMS said it will begin publicly reporting dialysis clinic performance on the following measures on Dialysis Facility Compare:

Nephrologists won’t see a difference in their monthly capitated payment for patients in 2016, but the final Medicare Physician Fee Schedule, which went into effect Jan.1, does include some new changes for physician services.