The Deputy General Counsel and Chief Legal Officers at the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services recently issued an Internal Memorandum clarifying that a recent Supreme Court ruling may limit HHS’s enforcement practices going forward. Consistent with the Court’s ruling, the Memorandum clarifies that subregulatory guidance issued without notice-and-comment rulemaking may not be used as the sole basis for an enforcement action when such guidance creates or changes a substantive legal standard.
