BY Rossanna J. Madrigal and Beth Anne Jackson, Brown & Fortunato   On March 8, 2023, the U.S. Department of Health and Human Services (HHS) released the Health Care and Public Health Sector Cybersecurity Framework Implementation Guide, Version 2 (the “Guide”). The Guide is a collaborative publication between the government and private sector that was developed by the HHS Administration for Strategic Preparedness and Response (ASPR) and the Health Sector Coordinating Council Cybersecurity Working Group....

BY Blinn E. Combs and Beth Anne Jackson, Brown & Fortunato In a virtual replay of last year’s action (TMA I), on February 6, the United States District Court for the Eastern District of Texas, Tyler Division (Court) overturned portions of the August 26, 2022 final rule (Final Rule) relating to certain arbitration procedures outlined in the No Surprises Act (NSA). As reported here in October, plaintiffs Texas Medical Associates and an independent physician (TMA)...

BY Phuong Nguyen and Beth Anne Jackson, Brown and Fortunato Early this year, a jury concluded a vascular surgery physician group (Group) violated the False Claims Act (FCA) by billing Medicare for services it had not fully performed at the time they were billed. While Medicare would typically deny a claim when the services are not fully performed, the Court, in response to the Group’s motion for judgment as a matter of law, ruled that...

BY Beth Anne Jackson, Brown & Fortunato   In a recent opinion and judgment, U.S. District Judge David Kacsmaryk declared that the United States Department of Health and Human Services (HHS) rule prohibiting clinics funded through Title X of the Public Health Service Act (Title X) from requiring parental consent or notice for the provision of services to minors was unlawful. Title X services include not only contraceptive services, but also sexually transmitted infection (STI)...

By Jacque S. Mayes and Beth Anne Jackson, Brown & Fortunato   On May 10, 2021, the Department of Health and Human Services (HHS) announced that the Office for Civil Rights would interpret and enforce Section 1557 and Title IX’s prohibitions on discrimination based on sex to include: (1) discrimination on the basis of sexual orientation; and (2) discrimination on the basis of gender identity (the “Notification”). Section 1557 prohibits discrimination on the basis of...

By Colleen Byrom and Beth Anne Jackson, Brown and Fortunato   Compensation and referral arrangements among healthcare providers, hospitals, and laboratories have been a subject of scrutiny for many years, especially when the referral of federal healthcare beneficiaries is involved. Earlier this year, the United States Department of Justice (“DOJ”) intervened in a whistleblower lawsuit against laboratory executives, a hospital executive, and several marketers and healthcare providers, alleging violations of the False Claims Act, Anti-Kickback...

By Beth Anne Jackson, Shareholder, Brown and Fortunato On September 22, 2022, the Texas Medical Association (TMA), along with a physician and Tyler Regional Hospital, sued the United States Department of Health and Humans Services, Department of Labor, Department of the Treasury, and their respective current leaders in their official capacity (Departments) seeking declaratory and injunctive relief from the No Surprises Act (NSA) final rule published August 26, 2022 (Final Rule). Specifically, the lawsuit (Complaint)...

BY Rossanna J. Howard and Beth Anne Jackson, Brown & Fortunato   On July 11, 2022, the Department of Health and Human Services (HHS) and its Secretary, Xavier Becerra, issued a general guidance memo titled “Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss” and a separate letter to health care providers addressing their obligations under the Emergency Medical Treatment and Active Labor Act (EMTALA), collectively referred to here...

BY Colleen Byrom and Beth Anne Jackson, Brown and Fortunato   On June 24, 2022, the U.S. Supreme Court published its opinion in Dobbs v. Jackson Women’s Health Organization. Penned by Justice Alito, the Court held that the U.S. Constitution does not “confer a right to abortion” and that the people and their elected state officials retain the authority to regulate abortion, thus overturning the Court’s prior decisions in Roe v. Wade and Planned Parenthood...

BY Rossanna Howard and Beth Anne Jackson, Brown and Fortunato On June 15, 2022, the Supreme Court issued an opinion, American Hospital Association et al. v. Becerra, No. 20-1114, slip op. (2022), overturning a previously upheld $1.6 Billion dollar cut to the Medicare 340B drug discount program (the “Program”). The Program was enacted in 1992. It is implemented by the Department of Health and Human Services (HHS) and administered by the Health Resources & Services...