On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2) to implement statutory amendments passed under Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (42
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CMS Issues Calendar Year 2023 Home Health Final Rule
On November 4, 2022, the Centers for Medicare & Medicaid Services (CMS) published the calendar year 2023 Home Health Prospective Payment System Rate final rule, which updates Medicare payment policies and rates for home health agencies. Some of the key changes implemented by the final rule are summarized below.…
CMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee Schedule
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued final rules concerning the 2023 Hospital Outpatient Prospective Payment System (OPPS) payment rates and 2023 Medicare Physician Fee Schedule (PFS). These final rules implement various updates and policy changes for Medicare payments under the PFS and OPPS, and…
DOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests
On October 17, 2022, the United States Department of Justice (DOJ) announced a $13 million settlement with health care services provider Sutter Health, which arose from alleged violations of the federal False Claims Act (FCA). These alleged FCA violations relate to Sutter Health billing the United States for toxicology screening tests performed by other labs.…
Advisory Opinion 22-17: OIG Declines to Impose Sanctions on a Health System for Forgiveness of Credit Line Note Owed by Clinic
On September 6, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-17 (Advisory Opinion), in which it declined to impose sanctions against a regional 501(c)(3) not-for-profit health care system that operates four hospitals (Health System) and a clinic that provide services to geographic areas that have been designated as medically-underserved areas and health…
Supreme Court Denies Certiorari in Three FCA “Particularity” Cases
On October 17, 2022, the Supreme Court denied certiorari in three cases asking the court to resolve a circuit split regarding the application of the particularity pleading requirement for allegations of fraud in False Claims Act (FCA) cases, as required under Federal Rule of Civil Procedure 9(b). The cases are: Johnson, et al. v. Bethany…
Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million
On October 18, 2022, the Department of Justice (DOJ) announced two settlements with CHC Holdings, LLC, an Oklahoma limited liability company doing business as Carter Healthcare (Carter), and two former senior corporate officers, resolving alleged violations of the federal False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (commonly referred to as the…
Recent NLRB Decision Requires Union Access to Parts of Asset Purchase Agreement
In a recent decision, the National Labor Relations Board (NLRB) determined that a hospital violated its duty to bargain when it failed to provide the union representing some of its workers with certain documents related to the sale of its parent organization. Specifically, in Crozer Chester Med. Ctr., 371 NLRB No. 129 (2022), the…
Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions
By Conor Duffy & Erin Howard
On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the imposition of sanctions under the federal anti-kickback statute (AKS). The OIG concluded that while beneficiary access to potentially life-saving medications is essential, the…
340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win
We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates for 340B hospitals” and therefore, that HHS exceeded its statutory authority by varying the 2018…