Health-care lawyers will be busy helping clients comply with or fight changing precedents on issues from abortion to drug pricing and the False Claims Act in the new year.
Meanwhile, the legal community is still reeling from a landmark year for Supreme Court precedent, where the justices overturned the constitutional right to abortion, weakened the administrative state, and raised the bar for criminal charges against doctors prescribing opioids.
Bloomberg Law talked with health-care scholars to learn about the biggest cases they’re watching in 2023. “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 James Hodge, a professor at Arizona State University’s Sandra Day O’Connor College of Law.
Reproductive health-care debates will move into the new year, as the landmark Dobbs decision that overturned Roe v. Wade creates legal questions that haven’t yet been answered by the high court.
Abortion-rights advocates will likely file lawsuits on the basis of gender equality, while anti-abortion groups may file a suit meant to force the Supreme Court to reconsider fetal personhood, health-care scholars said.
Meanwhile, the Biden administration’s enforcement of a mechanism that requires health-care providers to perform abortions in medical emergencies is already dividing district court judges.
The Biden 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, said Allison Hoffman, professor and deputy dean at the University of Pennsylvania Carey Law School. The decision in Texas against the Biden administration “leaves a lot of ambiguity on the ground,” about whether to adhere to federal or state law, she said.
This question will likely end up in the Supreme Court, Hoffman said.
Inflation Reduction Act
The Inflation Reduction Act, signed into law in August, will allow the CMS to
The pharmaceutical industry is strongly opposed to the law, arguing it will hinder drug development. The HHS has yet to initiate any sort of rulemaking implementing the IRA, so drugmakers still can’t sue the agency over the law.
“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 Cato Institute, a libertarian think tank.
False Claims Act
The Supreme Court heard arguments in December on the extent to which the government can intervene in False Claims Act litigation. Jesse Polansky sued Executive Health Resources Inc. alleging it defrauded Medicare. The key question the justices are deciding is whether the government can step in to end a whistleblower suit at any time.
The case is United States, ex rel. Jesse Polansky vs. Executive Health Resources, U.S., No. 21-1052.
The Supreme Court will also decide whether to hear two cases that could refine “what does it mean to knowingly violate the law” under the False Claims Act, Hoffman said.
In one case, a whistleblower claims that
In another, a whistleblower says that
“There is a lot of fraud and abuse of all different flavors out there” in health care, and the False Claims Act is a key tool the government has to curtail that behavior, Hoffman said.
The cases are United States, ex rel. Thomas Proctor vs. Safeway, Inc., U.S., No. 22-111 and Troy Olhausen vs. Arriva Medical, LLC, U.S., No. 22-374.
Preventive Service Coverage
A challenge to the Affordable Care Act’s preventive services mandate could have broader legal implications for the way agencies function, Hoffman said.
Braidwood Management Inc. asked the court to block the mandate, arguing that being required to cover HIV prevention drugs violates the company’s religious freedom.
A federal judge in Texas ruled that the preventive services mandate violates the Appointments Clause of the US Constitution because members of a task force, who aren’t subject to Senate confirmation, had been selecting which preventive services were covered.
If the decision is upheld by higher courts, “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?”
The courts’ determination could end up having a disproportionate impact on people who rely on pre-exposure prophylaxis to prevent HIV.
But “even if there is no mandate, a lot of employers are going to offer those types of coverage anyway,” Cannon said.
Civil Rights Claims
The Supreme Court heard oral arguments in November for a case that will decide whether Americans have a civil right to sue public entities that are funded by the federal government. Ivanka Talevski sued the Health and Hospital Corporation of Marion County for allegedly medicating, restraining, and transferring her late husband, who had dementia, without her consent.
The key question the justices debated is whether the Federal Nursing Home Reform Act allows citizens to sue state-run facilities under Section 1983, a civil rights law. Congress enacted FNHRA using its spending clause power, allowing the government to set standards for health-care facilities funded by the Centers for Medicare & Medicaid Services.
If the justices agree that FNHRA confers civil rights enforceable through private lawsuits under Section 1983, “it’s going to open the door to more litigation against specific health-care entities like nursing facilities that are doing their best to meet congressional requirements,” Hodge said.
If the answer is no, “that has huge ramifications for health-care enforcement, because it basically then falls on the Department of Health and Human Services to enforce compliance with Medicaid requirements,” said Carmel Shachar, 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.”
The case is Health and Hospital Corporation of Marion County vs. Ivanka Talevski, U.S., No. 21-806.