The U.S. Department of Justice urged a federal judge in Texas on Wednesday not to grant the request from dialysis providers to halt an interim final rule issued by the Centers for Medicare & Medicaid Services that is set to go into effect Jan. 13, Law 360 reported Jan. 11.

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 will be required to make patients aware of potential coverage options and educate them about the benefits of each to improve transparency for consumers. Facilities must also ensure that insurance plan issuers are informed of and have agreed to accept the third party payments.


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“The Interim Rule that plaintiffs challenge here is a limited and modest but urgently needed step to protect these vulnerable patients by providing greater transparency in the choice of coverage,” the defendants wrote in a response to the motion against them.

The plaintiffs of the suit, DaVita Inc., Fresenius Medical Care North America, U.S. Renal Care Inc., and Dialysis Patient Citizens allege that the CMS rule was issued in violation of federal law and threatens to cause significant and irreparable harm to dialysis patients.

“In a transparent effort to ensure its regulation takes effect before a new administration takes office, the Department of Health and Human Services on December 14, 2016, announced a sea-changing rule without any notice or comment—making it effective on an expedited basis on January 13, 2017—upending twenty years of HHS guidance governing the way in which End Stage Renal Disease patients obtain health insurance coverage necessary to obtain life-sustaining care,” according to the plaintiff’s filing from the suit.

In court, the DOJ argued that the final rule protects patients from being steered by their dialysis providers into plans that are in the best interest of the provider, but often not ideal for patients.

“Unfortunately, the main source of information for a patient faced with choosing what coverage option best fits his or her unique circumstances is often an agent of the dialysis facility. And the provider has an enormous financial conflict of interest given the boost to its bottom line that accrues from every patient who can be steered into  choosing a commercial plan. Even where a provider (or a provider-funded charity) makes payment of a patient’s premium, the choice that is right for the provider maybe wrong for the patient.”

The American Kidney Fund released a statement Jan. 1, urging the U.S. Department of Health and Human Services to withdraw the interim final rule.“By forcing patients who need charitable assistance to seek permission from insurers before applying for coverage in the individual market, the rule effectively cedes all decision-making to insurers, who have already taken steps to bar low-income dialysis patients from accessing their plans.”

The Renal Physicians Association also released comments on the rule.

“RPA strongly supports CMS’ vigorous pursuit of its broad fiduciary mission to ensure that Medicare program management and oversight issues are addressed promptly and appropriately. However, we believe that the [interim final rule] lacks balance, disproportionately addresses the coverage concerns related to third party payment, and will definitively harm a segment of the Medicare ESRD beneficiary patient population that could potentially benefit from the opportunity to obtain commercial insurance.”