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…

The Office of Inspector General (“OIG”) recently launched a new, redesigned hotline webpage to better guide the public through the tip and complaint reporting process. The OIG hotline operations accepts tips and complaints from all sources regarding potential fraud, waste, abuse, and mismanagement in the U.S. Department of Health and Human Services’ (“HHS”) programs. The OIG receives nearly 115,000 complaints each year. Much of this information, as reported in the OIG’s promotional video, has led…

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 requires agencies to adjust civil monetary penalties for inflation annually. Effective November 5, 2019, the Department of Health and Human Services released updated civil monetary penalties for the regulations its agencies are responsible for enforcing. Below are key changes applicable to healthcare providers. The physician self-referral law, commonly known as the Stark Law, imposes civil monetary penalties for referring certain designated health services to…

Healthcare providers should begin finalizing plans to implement the Centers for Medicare and Medicaid Services’ Omnibus Burden Reductions (conditions of participation) final rule, which becomes effective Nov. 29, 2019. The final rule, issued Sept. 26, 2019, is intended to remove Medicare regulations, contained primarily in providers’ conditions of participation that CMS has identified as unnecessary, obsolete or excessively burdensome on healthcare providers and patients. The rule finalizes the provisions of three distinct proposed rules: Regulatory…

On June 11, 2019, the Tenth Circuit affirmed an award of $92,592.75 in attorneys’ fees to the defendants in Pack v. Hickey, 776 F. App’x 549 (10th Cir. 2019). Pack had appealed the district court’s entry of summary judgment and related orders in favor of Defendants Maureen Hickey (“Hickey”) and Cloud Peak Initiatives, Inc. (“Cloud Peak”) on Pack’s claims under the False Claims Act (FCA), 31 U.S.C. §§ 3729-3733.  The Wyoming District Court also…