On June 27, 2022, the United States Supreme Court, by a vote of 9-0, overturned the lower circuit courts’ rulings affirming the convictions of two physicians of the unlawful distribution of controlled substances. In Ruan v. United States (Case No. 20-1410), consolidated with Kahn v. United States (Case No. 21-5261), the Supreme Court was asked to determine whether a physician may be convicted of unlawful distribution of controlled substances under 21 U.S.C. § 841(a)(1) without regard to whether, in good faith, the physician “reasonably believed” or “subjectively intended” that his or her prescriptions fall within that course of professional practice. The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “except as authorized.” A prescription is authorized when it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). The “vague and highly general regulatory language” left open the question of what conduct would fall under the statute’s exception and thus be considered legal. Continue Reading Supreme Court Reaffirms Mens Rea Requirement in Controlled Substance Health Care Fraud Cases and Government Burden to Prove Subjective Bad Faith

As the health care industry shifts from fee-for-service to value-based arrangements, providers are facing a lot of challenges. A provider’s relationship with payers is often strained by the new business model, and a provider’s ability to collaborate with payers has never been more important.

On this episode of Value-Based Care Insights, host Daniel J. Marino and I discuss how providers can successfully navigate value-based contracting with payers in a mutually beneficial way. Tune into the full episode here: https://www.luminahp.com/podcast/decoding-legalese-value-based-contracts.

We are pleased to share that the 2022 Chambers USA guide published and the Healthcare team achieved outstanding results. We earned Band 1 recognition in Missouri and Texas, and Band 2 Nationwide! Our healthcare lawyers ranked across practice areas include: Continue Reading Husch Blackwell Grows Rankings in 2022 Edition of Chambers USA

The American Health Law Association released its Special Edition of its Journal of Health and Life Sciences Law on Emerging Issues in Health Equity in the United State: Legal, Legislative, and Policy Perspectives. The association strives to advance public discourse on these issues for the benefit of AHLA members, the public, academia, and decision makers in both the legislative and executive branches of government. Continue Reading American Health Law Association New Publication on Emerging Issues in Health Equity in the U.S.: Legal, Legislative, and Policy Perspectives

The U.S. Department of Justice’s recent criminal prosecutions of health care executives for no-poach and wage-fixing conspiracies have been met with not-guilty verdicts. Despite these losses, the Department continues to prosecute this conduct, and antitrust enforcers will continue to investigate human resources practices that may restrain competition. Continue Reading Two Strikes for DOJ: Health Care Executives Not Guilty of Antitrust Conspiracies

Recent legislative changes indicate that Congress is committed to continuing to allow patients to access telehealth services after the COVID-19 public health emergency (PHE) ends, but it is gathering more information before making such changes permanent. Comments from the U.S. Department of Health & Human Services (“HHS”) Secretary Xavier Becerra and the HHS Office of Inspector General (“OIG”) indicate that HHS is committed to expanding telehealth beyond the end of the PHE and that the OIG recognizes the long-term benefits of access to these services. Continue Reading Telehealth Flexibilities Extended to Late 2022 and Likely Beyond

The Acute Care Hospital at Home model (ACHAH) provides traditional hospital inpatient acute-level services at home.  Prior to the pandemic a Centers for Medicare and Medicaid pilot study yielded positive results with respect to hospital readmission rates and follow-up emergency department visits. The ACHAH model appears to be a feasible alternative to traditional inpatient acute care that can improve quality of care and patient satisfaction. What was previously a trickle of interest turned into a wave of necessity as the pandemic overwhelmed hospitals and the health care system in 2020. In response to the pandemic, CMS began to provide hospital with broad regulatory flexibility to implement the ACHAH model. Continue Reading The Future of Hospital at Home

On March 23, 2022, the Occupational Safety and Health Administration (OSHA) published a notice in the federal register announcing a limited re-opening of the comment period regarding OSHA’s final standard to protect healthcare and healthcare support service workers from occupational exposure to COVID-19. The comment period will end on April 22, 2022, and the virtual public hearing will be held on April 27, 2022. The Emergency Temporary Standard (ETS) for Occupational Exposure to COVID-19 for  healthcare and healthcare support service workers (OSHA Healthcare ETS) was originally published on June 21, 2021. OSHA has re-opened the comment period to allow stakeholders to address changes the agency is considering that depart from the June 2021 version of the OSHA Healthcare ETS. Continue Reading OSHA Re-opens Comment Period and Schedules Public Hearing on ETS – Occupational Exposure to COVID-19

We continue to see an increase in fiduciary litigation involving employer-sponsored group health plans, particularly litigation involving mental health.  A recent New York Federal District Court case, Collins et al. v. Anthem, Inc. & Anthem UM Services, Inc., Case No. 1:20-cv-001969, is one example that may have wide-ranging impact. This case caught our attention because of its potential impact on plan design and plan administration of its mental health and substance use disorder (collectively “behavioral health”) benefits. Continue Reading New York District Court: The Choice of Medical Necessity Criteria is a Fiduciary Act

Throughout the COVID pandemic, healthcare employers have navigated the challenge of balancing safety concerns with employee requests for religious exemption from the vaccine.  Since lifting the stay of the CMS rule requiring certain healthcare workers to receive a COVID-19 vaccine, the US Supreme Court (Court) has refused to enjoin state and city vaccine mandates for workers who seek religious exemptions from such mandates. On March 7, 2022, the full Court rejected, without comment, an emergency application for an injunction that was previously denied by Justice Sotomayor to prevent enforcement of the New York City Department of Education’s COVID-19 mandate against suspended workers who refused vaccination based on religion.  In the wake of continued challenges to vaccine mandates based on religion, the U.S. Equal Employment Opportunity Commission (“EEOC”), released guidance on March  1, 2022 that addresses questions related to religious objections to vaccinations in the workplace. Healthcare employers should ensure that assessment of requests for religious exemptions for vaccine mandates comports with EEOC guidance. Continue Reading EEOC Issues Employer Guidance for COVID-19 Vaccinations and Religious Objections