A new conflict between Texas and Federal Law: HHS proposes A HIPAA rule to protect reproductive health care information

BY Colleen Byrom and Beth Anne Jackson, Brown, and Fortunato   The political battle between state abortion laws and federal laws and regulations wages on as providers struggle to remain in compliance with both sets of laws. Texas’s abortion law is no exception and has faced its own enforcement challenges. The newest challenge on the horizon comes in the form of modifications to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule regulations.  ...

Federal policy shift on antitrust enforcement creates uncertainty for healthcare mergers

BY Kianna Sitarski and Beth Anne Jackson, Brown & Fortunato   Healthcare providers are now facing increased scrutiny from the United States Department of Justice (DOJ) and the Federal Trade Commission (FTC) when it comes to antitrust enforcement in the context of mergers, acquisitions and other collaborations. On February 3, 2023, the DOJ issued a policy statement that withdrew previous DOJ-FTC joint guidance issued in 1993, 1996, and 2011 (Guidance) that provided “antitrust safety zones”...

HHS publishes new guidance to help healthcare providers address cybersecurity risks

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....

A no surprise “No Surprises Act” ruling

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)...

Damage calculations in False Claims Act must account for services eventually provided

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...

Title X providers left without instruction regarding parental consent in Amarillo federal court decision

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)...

Class challenge in Texas results in judgment against Biden Discrimination Policy

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...

DOJ cracks down on improper referral scheme among laboratories, hospitals, and health care providers

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...

Another “No Surprises Act” rule challenge by TMA

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)...

Texas legal challenge to EMTALA guidance results in injunction win

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...

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