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CMS Extends Deadline For Publication of Final Stark II, Phase III Rule

Client Alert | 1 min read | 03.21.07

As expected, CMS announced today that it is extending the timeline for publication of the final rule implementing the Stark Law (the “Phase III Rule”) for one year. With this extension, the interim final rule issued on March 26, 2004 (the “Phase II Rule”) will remain in effect until March 26, 2008, at which time CMS will publish the Phase III Rule.

The timeline for publishing a final regulation cannot exceed three years from the date of publication of the proposed interim final rule, unless there are “exceptional circumstances.” CMS attributes the “numerous and varied” public comments received following publication of the Phase II Rule, as well as the substantial “interagency coordination” among CMS, the Office of the Inspector General, and the Department of Justice, (resulting from their joint authority to enforce the Stark Law), as the justification for the one-year extension.

This leaves unanswered for at least one more year critical and outstanding issues under the Stark Law, including: 1) the Law’s applicability to Medicaid referrals and claims; 2) the potential for expansion of the physician recruitment exception to accommodate certain practical considerations; and 3) the potential narrowing of the in-office ancillary services exception to preclude certain referral practices that are understood to be deemed questionable by CMS.

Insights

Client Alert | 3 min read | 05.28.26

PFAS Regulatory Alert: EPA Rolls Back RCRA Proposed Rule on “Hazardous Waste” but Does Not Disturb Proposed RCRA Rule on PFAS

Earlier this month, the U.S. Environmental Protection Agency (EPA) withdrew a February 2024 Biden administration proposed rule, “Definition of Hazardous Waste Applicable to Corrective Action for Releases From Solid Waste Management Units,” under the Resource Conservation and Recovery Act (RCRA).[1] The withdrawn proposal would have revised RCRA corrective action regulations to expressly apply the broader statutory definition of “hazardous waste,” rather than only the narrower regulatory definition. Now, EPA is maintaining the status quo for corrective action under RCRA. However, EPA’s withdrawal of its proposed RCRA hazardous waste definition makes no mention of its corresponding proposal from 2024 to list nine per- and polyfluoroalkyl substances (PFAS) as RCRA hazardous constituents.[2] This disjointed withdrawal, while providing some certainty for regulated entities, does not resolve how EPA plans to address PFAS under the RCRA program....