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Danielle H. Tangorre represents and advises a broad range of health care providers, including clinical laboratories, long-term care facilities, behavioral health providers, substance abuse providers, physician group practices and licensed healthcare providers.  Read her full rc.com bio here.

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 Economics Security (CARES) Act (42 U.S.C. 290dd-2). Comments are being accepted for 60 days from publication.

Continue Reading HHS Proposes Rule to Align Part 2 Records and HIPAA

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.

Continue Reading DOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests

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 professional shortage areas (together, the Requestors).  The Health System had supported the establishment of the clinic, which is registered as a Free Clinic and been designated as a Federally Qualified Health Center (FQHC) Look-Alike (Clinic), (but is neither a FQHC nor does it receive funds under Section 330 of the Public Health Service Act). The arrangement involves the forgiveness of a credit line note entered into by the Health System with the Clinic. The OIG concluded that although the arrangement would constitute prohibited remuneration under the federal anti-kickback statute (AKS) if the requisite intent were present, the arrangement and the safeguards in place did not warrant the imposition of sanctions.

Continue Reading Advisory Opinion 22-17: OIG Declines to Impose Sanctions on a Health System for Forgiveness of Credit Line Note Owed by Clinic

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 Hospice, 21-462; U.S., ex rel. Owsley v. Fazzi Associates, Inc., et al., 21-936; and Molina Healthcare, et al. v. Prose, 21-1145. Molina also presented a second question over which circuits had split, regarding the correct interpretation of Universal Health Services, Inc. v. United States ex rel. Escobar and whether a request for payment without specific representations can be actionable under an implied false certification theory. (Petition for Writ of Certiorari).

Continue Reading Supreme Court Denies Certiorari in Three FCA “Particularity” Cases

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 “Stark Law”). One case settled claims that Carter had made improper payments to referring physicians in Oklahoma and Texas, while the other case settled claims that Carter had made false billing claims in Florida. Both matters were initiated by qui tam whistleblower complaints filed under the FCA. Carter agreed to pay more than $30 million to resolve the allegations.

Continue Reading Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million

The Department of Health and Human Services Office of Inspector General (OIG) recently released a Data Brief summarizing the findings of a review of program integrity risks related to telehealth services reimbursed by Medicare during the first year of the COVID-19 pandemic (the Pandemic).[1] The OIG analyzed Medicare and Medicare Advantage claims data from March 1, 2020, to February 28, 2021, focusing on providers that billed for telehealth services, with an emphasis on identifying providers that posed a high risk to the Medicare program.

Continue Reading OIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the Pandemic

On August 18, 2022, New Jersey Governor Phil Murphy signed S-315, “An Act concerning changes in control of health care entities” (the Act). The Act implements employment protection for healthcare workers when certain licensed health care facilities, staffing registries, and home care services in New Jersey undergo a change in ownership. The Act first requires that former health care entity employers provide the successor health care entity with information pertaining to employees (i.e., employee names, addresses, dates of hire, phone numbers, wage rates, employment classifications) not less than thirty days before a change in control. The Act also requires former health care entity owners to inform eligible employees of the rights provided by the Act and to post a notice of their rights under the Act in a conspicuous location.

Continue Reading New Jersey Governor Signs Act Concerning Changes in Control of Health Care Entities

On August 19, 2022, the Department of Health and Human Services (HHS), Department of Labor (DOL), and Department of the Treasury (DOT), released “Requirements Related to Surprise Billing: Final Rules” (the Rules). The Rules change and finalize the prior interim final rules concerning the information health insurers must share regarding the qualifying payment amount (QPA) and the independent dispute resolution (IDR) process under the No Surprises Act.  The Rules address comments received pertaining to the interim final rules as well as the recent judicial decisions in Texas Medical Association[1]and LifeNet. [2]

Continue Reading New Final Rule Under the No Surprises Act Released

HHS-OIG issued a new Special Fraud Alert on relationships with “purported telemedicine companies” on July 20, 2022. The Special Fraud Alert comes on the heels of a nationally coordinated takedown charging dozens of individuals criminally for their participation in an allegedly fraudulent scheme related to telemedicine, laboratories, and durable medical equipment (“DME”).[1] However, the alert comes after focus on telemedicine fraud cases in particular since 2019. The Special Fraud Alert identifies several characteristics of concern and common elements that individuals and companies should be aware of.

Continue Reading Suspect Characteristics Identified under a Telehealth Special Fraud Alert