On October 14, 2022, President Joe Biden signed Executive Order 14036, directing the Department of Health and Human Services (“HHS”) to consider innovative actions to drive down certain single-source prescription drug costs as the Biden-Harris Administration works to implement the Inflation Reduction Act of 2022 (the “Act”).

Stories can be powerful tools. Stories can create a sense of connection and have the power to shape the lives of both the storyteller and the listener. Stories also make ideas and experiences relatable and can encourage exploration or action. And it was the stories I heard from members of AHLA’s Women’s Leadership Council that inspired me to write this column as a reminder of the incredible impact of AHLA’s educational mission supported by AHLA’s philanthropic initiatives.

Environmental, Social and Governance (ESG) strategy is an increasingly more common consideration for those undertaking healthcare M&A or capital investments. The nature of healthcare poses unique ESG risks in terms of community impact and involvement, retention in the workforce, and environmentally friendly buildings and medical supplies. As ESG concerns continue to become more important to investors and acquirors—and as government regulations increasingly necessitate movements towards ESG-friendly business practices—both for-profit and non-profit entities in the healthcare industry need to ensure that proper ESG standards are maintained.

DEA waivers regarding the Ryan Haight Act could play a major role in telehealth’s future.

In the first decade of the 21st century, deaths attributable to overdoses of prescription drugs saw an alarming spike in volume, led higher by a tripling of deaths due to opioid use. Amid this surge, Congress enacted the Ryan Haight Online Pharmacy Consumer Protection Act in 2008 as part of an attempt to rein in the burgeoning online marketplace for prescription drugs—particularly those involving controlled substances—which had largely evaded prior enforcement actions.

On July 26, 2022, Judge Jeremy Kernodle of the Eastern District of Texas affirmed that certain parts of the Interim Final Rule Part II implementing the No Surprises Act (the Act) were invalid. This ruling is nearly identical to Judge Kernodle’s February decision in Texas Medical Association & Corley v. US Dept. of Health and Human Services. This decision vacated a portion of the Interim Final Rule that required arbitrators to give more weight to the out-of-network rate, including what is called the Qualified Payment Amount (QPA), over other permissible factors. The rule’s requirement ultimately contradicted the Act’s direction that arbitrators consider various factors, and not weight any one more heavily than another.

Workplace violence has become a hot topic in today’s discourse; however, workplace violence is not just headline fodder for media outlets. The trend is well-documented and especially felt by the healthcare industry which continues to experience the brunt after the onslaught of COVID-19. In 2018, 73% of all nonfatal workplace violence incidents involved healthcare workers. A late 2020 survey reported that 20% of nurses reported they were facing an increase in workplace violence after the COVID-19 pandemic began. Another study reported a 14.6% increase in workplace violence at New Jersey hospitals over the prior three years.

Each July, the Medicare Administrative Contractors issue notices of a 2% Medicare payment reduction to those providers who did not meet quality data reporting requirements. Those notices have been sent. In this episode, Husch Blackwell’s Meg Pekarske and Jacob Harris talk about the issues providers faced in 2021 and how to pursue an appeal of

Background  

In direct response to the significant challenges experienced by long term care (LTC) facilities throughout the COVID-19 pandemic, the Biden-Harris Administration announced its commitment to improving safety and quality of care. During the March 1, 2022 State of the Union address, President Biden reaffirmed the Biden-Harris Administration’s commitment to protecting residents and staff of nursing homes. The Biden-Harris Administration has since taken steps to establish new minimum staffing ratios within nursing or skilled nursing facilities (SNFs), increase scrutiny of poorly performing nursing homes, and improve quality care transparency for customers seeking a SNF.

As many hospices continue to diversify into new business lines, staying abreast of enforcement trends outside of hospice is more important than ever. Home health in particular, is receiving significant government scrutiny. In this episode, Husch Blackwell’s Meg Pekarske talks with Bryan Nowicki and Erin Burns about a new round of home health audits being

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.