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News Briefs: January 25, 2021

On its first day, the Biden administration announced a Regulatory Freeze Pending Review.[1] That makes the fate of the flurry of HHS and CMS regulations released in the waning days of the Trump administration uncertain. There’s no way to predict exactly what CMS will do. According to attorneys at K&L Gates, the wording of the memo about the freeze, which came from Chief of Staff Ronald Klain, “is too ambiguous to apply to any given rule,” especially the Most Favored Nation drug-pricing rule that’s on hold because of a court order. CMS Acting Administrator Elizabeth Richter will decide, with input from the HHS Office of the General Counsel, which regulations will be pulled back, the attorneys said. Another example of a rule that’s on pause: the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule. It requires review of most HHS regulations every 10 years. If they aren’t reviewed, they expire.

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