After the Supreme Court weakened the administrative state, overturned the constitutional right to abortion, and raised the bar for criminal charges against doctors prescribing opioids in 2022, 2023 is shaping up to be another big year for health law issues in the highest court in the land.
“How far the Supreme Court is willing to go” in reversing established precedent “will impact how we respond to everything from global climate change to reproductive health, to public health services, to public health emergency responses in the future,” said professor James Hodge of the Sandra Day O’Connor College of Law at Arizona State University.
Some of the biggest health law issues this year look to be abortion, civil rights claims, the False Claims Act, the Inflation Reduction Act, and preventive service coverage.
The Dobbs v. Jackson Women's Health Organization decision that overturned Roe v. Wade created many legal questions that haven’t yet been answered by the Supreme Court, and abortion-rights groups will more than likely file lawsuits on the basis of gender equality, while anti-abortion groups may attempt to force the Supreme Court to reconsider the personhood of fetuses.
The Biden administration has been trying to enforce a requirement that healthcare providers perform abortions in medical emergencies, and this has already begun to divide district court judges.
The administration “is trying to give some comfort to doctors who are working in emergency departments” and trying to comply with the Emergency Medical Treatment & Labor Act (EMTALA), said Allison Hoffman, a professor of law and deputy dean at the University of Pennsylvania Carey Law School.
Civil Rights Claims
The issue of whether Americans have a civil right to sue public entities that are funded by the federal government came before the Supreme Court in November, when it heard oral arguments on whether the Federal Nursing Home Reform Act (FNHRA), under Section 1983, allows citizens to sue state-run facilities. Congress used its spending clause power to enact FNHRA, which allows the government to set standards for healthcare facilities that are funded by the Centers for Medicare & Medicaid Services (CMS).
If the justices decide that the FNHRA does indeed confer civil rights that are enforceable through private lawsuits, “it’s going to open the door to more litigation against specific healthcare entities like nursing facilities that are doing their best to meet congressional requirements,” according to Hodge.
However, if the justices decide the FNHRA does not confer those rights, “that has huge ramifications for healthcare enforcement, because it basically then falls on the Department of Health and Human Services to enforce compliance with Medicaid requirements,” said Carmel Shachar, the Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. “They’re just not staffed to do that.”
False Claims Act
In December, the Supreme Court heard further arguments on the extent to which the government can intervene in False Claims Act litigation, namely whether the government can step in at any time to end a whistleblower suit.
Hoffman said the Supreme Court will decide whether to hear two cases that could refine what it means to knowingly violate the law under the False Claims Act.
“There is a lot of fraud and abuse of all different flavors out there” in healthcare, and the False Claims Act is a key tool the government has to curtail that behavior, according to Hoffman.
Inflation Reduction Act
Signed into law in August, the Inflation Reduction Act (IRA) will allow the CMS to begin negotiating prescription drug prices for the first time in 2026.
However, the pharmaceutical industry has vociferously opposed the IRA, arguing it will hinder its ability to develop new drugs. As of now, drugmakers can’t sue the agency over the law because the Department of Health and Human Services (HHS) has not initiated any rulemaking implementing the IRA.
“If those provisions have any bite, pharma is going to try to undo them either through legislative lobbying, administrative lobbying, or, if all that fails, through the courts,” said Michael Cannon, Director of Health Policy Studies at the libertarian think tank the Cato Institute.
Preventive Service Coverage
A federal judge in Texas has ruled that the preventive services mandate of the Affordable Care Act (ACA) violates the Appointments Clause of the U.S. Constitution because members of a task force, who aren’t subject to Senate confirmation, had been selecting which preventive services were covered.
A challenge to this mandate could have broader legal implications for the way agencies function, according to Hoffman.
If the case makes its way to the Supreme Court and the Texas judge’s ruling is upheld, “it could prevent Congress from having the authority to look to the experts on science questions,” Hoffman said. “Can you imagine if Congress had to decide what preventative services should be covered or not covered?”
But “even if there is no mandate, a lot of employers are going to offer those types of coverage anyway,” Cannon said.