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 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...

By Beth Anne Jackson, Brown & Fortunato   In its Advisory Opinion No. 22-09 issued April 25, 2022 (Opinion), the Office of Inspector General (OIG) concluded that a proposed arrangement (Arrangement) involving per-patient fees for specimen collection, processing, and handling paid by a clinical laboratory (Lab) to contracted hospitals (Hospitals) would generate “prohibited remuneration under the Federal anti-kickback statute, if the requisite intent were present,” constituting grounds for the imposition of sanctions, even if the...

BY Colleen T. Byrom and Beth Anne Jackson, Brown & Fortunato On April 22, 2022, the Supreme Court of Texas ended a long-standing court battle between a cardiovascular surgeon and a Houston-area hospital system. The Court’s unanimous decision in Memorial Herman Health System v. Miguel A. Gomez, III, M.D. and Miguel A. Gomez, M.D., P.A., overturned a more than $6.3 million jury award made in favor of the surgeon’s defamation and business disparagement claims against...

By Rossanna Howard, Partner, and Allison Shelton, Partner, Brown & Fortunato Gender-affirming medical care has been the subject of several recent initiatives and proceedings in Texas, including an opinion from the Texas Attorney General and a letter from Governor Greg Abbott to the Texas Department of Family and Protective Services (DFPS).  Most recently, on March 21, 2022, the Third Court of Appeals in Austin enjoined DFPS from acting on the Governor’s written directive that “gender-transitioning...

By Phuong D. Nguyen and Beth Anne Jackson, Brown & Fortunato, P.C. Hot on the heels of approving new CPT codes for remote physiologic monitoring (RPM), the Centers for Medicare & Medicaid Services (CMS) approved new CPT Codes for remote therapeutic monitoring (RTM), effective January 1, 2022. The new RTM codes are related to monitoring respiratory system status, musculoskeletal system status, therapy adherence, therapy response (CPT codes 98976 and 98977). Similar to RPM codes, RTM...

By Beth Anne Jackson and Allison Shelton, Brown & Fortunato, P.C. In its annual report on False Claims Act (FCA) recoveries released February 1, 2022, the Department of Justice confirmed that health care fraud was “once again the leading source” of its FCA settlements and judgments, totaling more than $5 billion in the fiscal year 2021. This compares to $1.8 billion in FY2020. Before reviewing the details of the report, it is worthwhile to examine...