U.S. District Judge Amos Mazzant, in granting providers and dialysis advocates a temporary restraining order against the rule, said that the federal Health and Human Service Department's issuance of the rule had been "arbitrary and capricious."
Mazzant also said that the plaintiffs opposing the rule had a high likelihood of getting it permanently tossed out because there is good reason to believe HHS did not follow the proper procedure for giving the public notice and a chance to comment on the proposed rule.
"The Court determines that HHS did not have good cause to bypass notice and comment; thus, the Rule should be vacated," Mazzant wrote in his decision, issued in federal court in Texas.
The rule was announced in mid-December, and had been scheduled to take effect Jan. 14. An earlier Mazzant ruling postponed the implementation pending his consideration of a request for the temporary restraining order from the plaintiffs, which included the providers DaVita, Fresenius Medical Care and U.S. Renal Care, along with a dialysis patients organization.
The Justice Department, which is defending the rule, declined to comment.
DaVita said, "On behalf of our patients we are pleased that the court took the important step of putting a hold on a Centers for Medicare and Medicaid Services (CMS) rule that would have harmed thousands of the sickest patients in America." CMS is a division of HHS.
Hrant Jamgochian, chief executive of Dialysis Patient Citizens, a leading advocacy group for people with kidney disease and the lead plaintiff in the suit, said, "The court recognized the critical need to suspend enforcement of a harmful regulation that would give insurers illegal veto power over a patient's ability to receive charitable assistance that helps them afford health insurance."
"CMS hastily released the rule without recognizing its harmful impact on patients' ability to keep their current health plan," Jamgochian said.