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Dr. John Pepe and Dr. Richard Sherman (“Relators”), acting as whistleblowers, brought a qui tam action against Fresenius Medical Care Holdings, Fresenius Vascular Care, Inc., and Dr. Gregg Miller (“Defendants”).  Relators’ complaint alleged that the Defendants engaged in fraudulent billing practices under the False Claims Act (“FCA”) and analogous state laws.  Last week, the United States District Court for the Eastern District of New York dismissed Relators’ case because they failed to plead their allegations with particularity as required by Federal Rule of Civil Procedure 9(b).Continue Reading Stringent Requirements for Pleading Fraud Under Rule 9(b).

The United States District Court for the Northern District of Indiana recently dismissed a case involving allegations of fraudulent Medicaid claims and self-referrals.  The case, United States of America and State of Indiana ex rel. Bradley A. Stephens v. Nuclear Cardiology Associates (“NCA”), serves as a critical reminder of the stringent requirements for pleading fraud under the False Claims Act (FCA) and the Stark Law.Continue Reading General Allegations Without Representative Examples Are Insufficient to Survive a Motion to Dismiss

In the world of False Claims Act (“FCA”) litigation, the recent case United States ex rel. Robert C. O’Laughlin, M.D. v. Radiation Therapy Services, P.S.C., et al. serves as an important reminder of the need for concrete evidence when asserting qui tam FCA claims.Continue Reading The Anatomy of a Failed Qui Tam Case: Lessons from U.S v. Radiation Therapy Services

On September 1, 2023, the U.S. Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (“CMS”) issued a much anticipated and contested proposed rule that seeks to establish minimum staffing level requirements for nursing homes.  The proposed rule represents the first time the federal government has proposed comprehensive nationwide nursing home staffing requirements, although various states have already enacted their own staffing requirements.Continue Reading CMS Proposes Minimum Staffing Requirements and Enhanced Facility Assessments for Nursing Homes

Third Circuit Rules on Manufacturer Restrictions on Contract Pharmacies

The first of three pending appeals on whether a pharmaceutical manufacturer can limit distribution of covered 340B drugs to contract pharmacies resulted in a clear victory for pharmaceutical manufacturers.  The Third Circuit resolved conflicting decisions among district courts within the Third Circuit by ruling that the…

On December 29, President Joe Biden signed into law the Consolidated Appropriations Act, 2023 (P.L. 117-164) (the “Act”)—an approximately $1.7 trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes.  Continue Reading President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

On April 6, 2022, BayCare Health System Inc. (BayCare) entered into a $20 million settlement under the False Claims Act with the U.S. Department of Justice (DOJ) to resolve allegations that it had made donations in order to improperly inflate the funding four of its hospitals received from the federal Medicaid program. According to the agreement, BayCare did not formally admit wrongdoing or liability; rather, BayCare settled in order to “avoid the delay, uncertainty, and expense of litigation.”
Continue Reading Not-So-Charitable Donations: DOJ Achieves a $20 Million Settlement for a Backdoor Donation Scheme for Increased Medicaid Contributions

On March 23, the Centers for Medicare and Medicaid Services (CMS) approved Section 1135 waiver requests submitted by the California Department of Health Care Services (DHCS) as part of its response to the COVID-19 pandemic.  The waiver requests were submitted by DHCS on March 16 and March 19, 2020.

As discussed in a previous blog post, Section 1135 authorizes the U.S. Department of Health and Human Services to waive federal Medicare, Medicaid, and Children’s Health Insurance Program requirements in order to respond to a public health or national emergency. As of March 24, CMS had approved Section 1135 waivers related to the COVID-19 pandemic from 13 different states.

With the approval granted by CMS, DHCS is permitted to take the following actions in regards to its Medicaid program (Medi-Cal), effective retroactively to March 1 and to extend until the end of the public health emergency:Continue Reading CMS Approves Medi-Cal Section 1135 Waivers

On February 11, the U.S. Court of Appeals for the Seventh Circuit ruled that consultants who provide services to nursing homes and long-term care facilities lack standing to sue the state Medicaid agency and its contracted Managed Care Organizations on behalf of patients.

In Bria Health Servs., LLC v. Eagleson, No. 18-3076 (7th Cir.