Last week, the Centers for Medicare & Medicaid Services issued a Proposed Rule that, if finalized, would extend the application of the “36-Month Rule” from home health agencies (“HHAs”) to also include hospice agencies as well.
Continue Reading CMS Proposes to Expand 36-Month Rule to Hospice Agencies
The Supreme Court issued a number of headline-grabbing decisions this term on topics like religious accommodation, LGBTQ protections, and consideration of race in college admissions. These decisions are wide-reaching and impact individuals, employers, and higher education institutions. Though not nearly as wide-reaching, the Supreme Court also issued two important decisions this year dealing with the False Claims Act (FCA) that could have dramatic impact nonetheless for those ensnared in an FCA action.
Continue Reading False Claims Act Update: A Mid-Year Review (2023)
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions. The guidance document applies to clinical trials that will be conducted under investigational new drug applications, including clinical trials that are not intended to support marketing applications. Notably, the use of the term “psychedelic” in the guidance document is intended to encompass “classic psychedelics” that are understood to be 5-HT2 agonists (e.g., psilocybin and lysergic acid diethylamide (LSD)) as well as entactogens or empathogens (e.g., methylenedioxymethamphetamine (MDMA)). This is the first FDA draft guidance that discusses designing clinical trials for psychedelic drugs.
Continue Reading Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs
In his article The Shield Becomes a Sword, Nick Healey discusses Article I, Section 38 of the Wyoming Constitution, which guarantees the right of every competent adult to make their own healthcare decisions and was passed in 2012 in response to concerns over the Patient Protection and Affordable Care Act (ACA) and its potential limitations on patient choice. Recently, the Wyoming Legislature’s attempts to restrict certain healthcare decisions, such as abortion and gender-affirming medical care, have been challenged in court under the argument that they violate Section 38. The article explores the tension between the right to make healthcare decisions and the possibility of reasonable restrictions on those rights, ultimately leaving the interpretation of Section 38 up to the courts.
On June 14, 2023, a federal jury found that a Georgia physician knowingly violated the False Claims Act following a two-week trial on allegations that he made false claims to the Medicare Program. Now, despite just $1.1 million in improper payments stemming from false claims, a federal court is likely to impose a judgment that exceeds $27 million after adding statutory per-claim penalties and trebling the amount determined by the jury to be false.
Continue Reading Georgia Physician Awaits $27+ Million Judgment Following False Claims Act Trial Loss
Following two weeks of trial testimony, a Travis County jury recently rendered a $10 million verdict in a novel corporate practice of medicine (CPOM) case. The jury found in favor of a physician hospitalist group that claimed a management company repeatedly broke its promise to comply with the state’s CPOM prohibition, putting profits over patients, among other wrongdoings.
Continue Reading Texas Jury Renders $10 Million Verdict in Novel Corporate Practice of Medicine Case
The Department of Health and Human Services (HHS) through its Office of Inspector General (OIG), announced plans for significant updates and modernization of OIG compliance program guidance (CPG) to improve their accessibility and usability for healthcare entities.[1] Originally issued in 1998, the CPG provide healthcare organizations across the industry with guidance on developing, implementing, and maintaining internal compliance controls. In the 25 years since, the OIG has issued multiple and specific CPGs that apply to particular segments of the healthcare industry including Medicare Advantage organizations, hospitals, home health agencies, nursing homes, and clinical laboratories. However, over time the CPGs have not sufficiently kept up with the innovations and growth of the healthcare industry.
Continue Reading OIG Announces Upcoming Changes to Its Compliance Program Guidance Resources for the Healthcare Industry
Cosmetic surgeries are on the rise. One study of cosmetic surgery data found that body procedures like tummy tucks, buttock augmentation, and liposuction increased by 63 percent from 2020 to 2021.[1] Facelifts were up 54 percent.[2] And breast procedures were up 48 percent.[3] According to that study, Americans spent over $14.6 billion on aesthetic procedures in 2021 with surgical revenues increasing by 63 percent.[4]
Continue Reading Justice Department Sues Iowa Surgeon Under False Claims Act for Masking Non-Covered Cosmetic Procedures as Covered Surgeries
Healthcare employers can improve patient outcomes by infusing diversity, equity, inclusion, and accessibility (DEIA) into their hiring, retention, and training practices. Legal minimums require that employers cannot make employment decisions based on any protected category, including race, national origin, and sex. But beyond these requirements, healthcare organizations need to prioritize DEIA to mitigate negative patient outcomes and increase the ability to provide high-quality patient care.
The Joint Commission has implemented healthcare equity standards that can be integrated into various hospital, ambulatory, and behavioral healthcare accreditation programs. Healthcare employers can take practical and proactive steps to improve patient outcomes by creating a health equity roadmap, assessing health-related social needs and creating a plan to address them, and staffing facilities with diverse employees who bring a variety of perspective and experiences that can build connections with the community.
Read more on our L&E Law Insights blog.
The Department of Health and Human Services (HHS) has announced its plan to end the Federal Public Health Emergency (PHE) for COVID-19 on May 11, 2023. Due to the COVID-19 pandemic, emergency declarations, legislation, and regulatory waivers across government agencies, including the Centers for Medicare & Medicaid Services (CMS), allowed for flexibility in the delivery of care to patients, including the expanded use of telehealth. Originally intended to conserve healthcare resources and prevent unnecessary exposure to COVID-19, the use of virtual care has exploded since the beginning of the pandemic to become an intrinsic, essential part of the healthcare delivery system. Now, at the end of the PHE, we examine the path forward for telehealth and the extent to which providers may continue to offer it to patients.
Continue Reading Two Weeks’ Notice for the Public Health Emergency: What’s Next for Telehealth