The Deputy General Counsel and Chief Legal Officers at the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) 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…

On October 4, 2019, the U.S. Attorney’s Office for the Central District of California announced a settlement in which the Retina Institute of California Medical Group, its former CEO, and several of its physicians paid the United States and California approximately $6.65 Million to settle False Claims Act allegations.  The settlement related to accusations of billing for unnecessary eye exams, improperly waiving Medicare co-payments, and violating other regulations.  Between January 2006 and August 2017, the…

As discussed in an Oct. 9 alert, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute and the Civil Monetary Penalties Law. This client alert, the fifth in McGuireWoods’ summary series on these proposed rules, focuses on the Centers for Medicare & Medicaid Services’ (CMS) three proposed Stark Law exceptions aimed at reducing the regulatory burdens that healthcare providers…