The United States District Court of the Eastern District of Texas on Jan. 25 issued a preliminary injunction prohibiting the Centers for Medicare & Medicaid Services from implementing an interim final rule that created new requirements for dialysis providers that make payments of premiums for individual market health plans.

DaVita Inc., Fresenius Medical Care, U.S. Renal Care Inc., and Dialysis Patient Citizens filed suit against the Department of Health and Human Services and alleged that the CMS rule was issued in violation of federal law and threatens to cause significant and irreparable harm to dialysis patients.

The court granted a temporary restraining order on Jan. 12.

“The preliminary injunction is indefinite in duration and therefore will remain in effect as long as the court does not change it,” according to a statement from FMC.


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“The Court is not persuaded that HHS had good cause to bypass notice and comment. When pressed at oral argument for why HHS could not go through the procedures required by the [Administrative Procedures Act],” Judge Amos Mazzant wrote in his ruling.

“Defendants were unable to identify any emergency that justified publishing a rule without notice and comment. Defendants claimed HHS decided it was facing a crisis situation after reviewing the information gathered through the [request for information]. Defendants further claimed immediate action was necessary because delay would put lives at risk. But such arguments ‘could as easily be used to justify immediate implementation of any sort of health or safety regulation.’”

The ruling was praised by the American Kidney Fund, whose Health Insurance Premium Program provides premium assistance to dialysis patients.

“We look forward to working with the Trump Administration to develop clear, common-sense rules that will guarantee dialysis patients can choose the health coverage that is best for them—even if they need charitable assistance to afford it,” said LaVarne A. Burton, American Kidney Fund president and CEO.

The final rule created new requirements for dialysis providers that make payments of premiums for individual market health plans directly, or through another entity.

Starting Jan. 13, dialysis facilities would have been required to make patients aware of potential coverage options and educate them about the benefits of each to improve transparency for consumers.

The lawsuit focused on the requirement that facilities must ensure that insurance plan issuers are informed of and have agreed to accept the third party payments.