Notable Health Law Decisions of 2022

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2022 has been a year of major court decisions impacting various aspects of healthcare law and pharmaceutical law. Here is a summary of the most important of these decisions:

U.S. Supreme Court reversals Roe vs. Wade

The highly controversial decision of the United States Supreme Court in Dobbs v. Jackson Women’s Health Organization on June 24, 2022, overturned nearly 50 years of the constitutional right to abortion established by the Court in Roe vs. Wade. Within weeks, highly restrictive abortion laws took effect in a dozen states, and similar laws are expected in a dozen more in the coming weeks. Amid legislation and court rulings, abortion accessibility in some states has changed daily.

Legal changes are not the only developments affecting access to abortion. Doctors and pharmacists have expressed concern about legal exposure in some states for engaging in procedures or prescribing pills that could be construed as facilitating unauthorized abortions. The Biden administration issued guidelines in July 2022, saying the Emergency Medical Treatment and Labor Act required doctors to perform abortions in certain emergency circumstances, despite state laws. This guidance led the Texas Attorney General to file a complaint three days later. It’s unclear whether the Biden administration will retaliate with formal regulation to back up its informal advice on the matter.

Three court rulings have multi-billion dollar revenue implications for the hospital industry

First come Becerra v. Empire Health Foundation, the U.S. Supreme Court sided with the U.S. Department of Health and Human Services (HHS) in its calculation of “disproportionate hospital share” payments for hospitals seeing large numbers of low-income patients. revenue. This decision translates into less money for hospitals.

Then the U.S. Supreme Court rejected a $1.6 billion annual reduction in hospital reimbursement under the 340B program, which guarantees drug discounts to hospitals in low-income areas. This rebate program began in 2018 and has spread the savings across the entire hospital industry. Under the court’s ruling, hospitals will no longer benefit from these savings, and it’s unclear how regulators will treat rebates given in previous calendar years. The Supreme Court rendered this decision in American Hospital Association et al. vs. Becerra et al.

Finally, in Texas Medical Association et al. v. United States Department of Health and Human Services et al., 2022 US Dist. LEXIS 31807 (2022), the U.S. District Court for the Eastern District of Texas struck down the arbitration system that is central to the No Surprises Act. This law establishes procedures for resolving out-of-network reimbursement disputes between insurance companies and emergency medical care providers. The No Surprises Act aims to protect patients from unexpected medical bills for medical care performed by out-of-network providers. The US Department of Justice is drafting a final rule to address the issues raised in the Texas court ruling.

U.S. Supreme Court rules on opioid cases under CSA

In Ruan vs. United States, the U.S. Supreme Court has changed the standard that the U.S. Department of Justice (DOJ) must meet to prosecute doctors under the Controlled Substances Act (CSA) for opioid abuse. The Court ruled that the DOJ had to prove beyond a reasonable doubt that the doctors knew they were not practicing medicine legitimately. This newly strengthened standard has cast doubt on ongoing CSA lawsuits across the country, and physicians already convicted under the CSA are beginning to challenge their convictions in court.

Lawyers representing pharmacies and drug companies in civil opioid litigation are also trying to use Roan to support their defense in certain cases. For example, attorneys for Walmart Inc. pharmacies, which the DOJ accused of exacerbating widespread opioid abuse, said the DOJ should dismiss parts of its case because of the ruling in Roan. In response, the DOJ sought to amend its complaint to add facts showing Walmart’s liability.

In related news, drug distributors won a significant victory in federal court in West Virginia, receiving a court ruling that shielded them from liability for opioid abuse in Cabell County. These cases were Town of Huntington v. AmerisourceBergen Drug Corp. et al.case number 3:17-cv-01362, and Cabell County Commission v AmerisourceBergen Drug Corp. et al., case number 3:17-cv-01665, both in U.S. District Court for the Southern District of West Virginia.

U.S. Supreme Court Raises ‘Major Issues Doctrine’ in Crafting Executive Branch Rules

In West Virginia v. Environmental Protection Agency, the US Supreme Court explicitly invoked the “major issues doctrine” in response to the EPA’s rulemaking. While the decision has significant implications for the EPA and climate change, it could have even more serious repercussions for the US Department of Health and Human Services (HHS). According to APE decision, regulations of great economic and political importance can be described as “major issues”. Therefore, agencies issuing these regulations must identify “clear congressional authorization” for these regulations.

For HHS, this decision could be a significant stumbling block. HHS oversees more than $1.5 trillion in annual spending and issues thousands of pages of regulations each year. As a result, litigation is likely to arise in response to disfavored regulations arguing that they pose “big questions” and exceed the authorization of Congress.

The APE The decision also illustrates a growing trend of judges interpreting federal law without using the Chevron standard of deference; the High Court this year decided two other HHS cases in which they also avoided the Chevron totally frame. Chevron deference is a long-standing standard that federal courts have used to defer to agencies’ reasonable interpretations of ambiguous statutes. In the absence of Chevroncourts can strike down regulations more frequently.

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