HIMSS23: Health policy post-Dobbs a 'confusing muddle,' panel says

Lawyers Matthew Fisher, left, and Oliver Kim discuss the legal landscape in healthcare post-Dobbs at the HIMSS23 Global Conference in Chicago on Tuesday.

Photo: Jeff Lagasse/Healthcare Finance News

The Supreme Court's decision in Dobbs v. Jackson Women's Health Organization introduced a significant amount of confusion into the healthcare industry. The decision, which effectively overturned Roe v. Wade and left it up to states to determine their reproductive health policies, also left open the possibility of operational impacts to various stakeholders.

It also left a number of questions unanswered: What care can be delivered and where? What technology solutions are creating risks to data?

As a lawyer, Matthew Fisher's standard reply is, "It depends."

Fisher, general counsel for Carium, and Oliver Kim, adjunct professor of law at the University of Pittsburgh School of Law, reviewed the current legal landscape as it pertains to reproductive health at the HIMSS23 Global Conference in Chicago on Tuesday.

The Biden administration's response to the Supreme Court's decision was to issue a pair of executive orders – one directing federal agencies to pursue ways to protect reproductive rights under existing law, and one stating that individuals have the right to cross state lines to pursue abortion services. 

As Fisher pointed out, however, this response is limited in the fact that an executive order cannot establish a new law. The executive orders, he said, were more about setting down the principals embraced by the current administration.

That leaves some federal agencies with concerns. The Department of Health and Human Services' Office of Civil Rights (OCR), which enforces HIPAA, was initially concerned that law enforcement would request protected health information (PHI). An organization or entity's recourse in that instance would be to take advantage of a linguistic vagary in the privacy rule, whereby it says that an entity "may" disclose that information. 

"Theoretically, even if someone follows the process, someone could say the 'may' means they don't have to share it," said Fisher. 

And then there's drug development under the Food and Drug Administration. The Supreme Court is expected to rule this week on a challenge in federal district court in Texas over the drug Mifepristone – essentially an abortion pill. The drug has been around for about 20 years, and the FDA had very strict labeling requirements that limited its use.

But during the COVID-19 pandemic, the FDA temporarily suspended some of the requirements and, after looking at the evidence, decided to continue its use over telehealth, so creating a new option for pharmacists to get a certification to dispense the drug.

That, said Kim, spurred 20 Republican attorneys general to write letters to major pharmacy chains, warning that if they certified pharmacists in their states it would create challenges for the chains in being able to dispense the drug.

"The FDA is also in the process of reviewing an application for over-the-counter birth control – whether or not that can just be off the shelf," said Kim. "That decision is probably going to happen later this year."

One of the trickiest areas, legally, concerns the Emergency Medical Treatment and Labor Act (EMTALA). The part of the law that's relevant to reproductive health revolves around the idea that an emergency department has an obligation to stabilize a person's condition before discharge, without regard for insurance status. HHS came out with interpretive guidance saying this type of care might involve medication that may now be illegal in the state they're in, because loss of pregnancy is a risk. 

"Obviously, that's been challenged," said Fisher. "Two cases have been filed in federal district court, one in Texas and one in Idaho. In Texas the court issued an injunction. They haven't decided on the merits, but feel there's the potential for irreparable harm. It stops the lawsuit until that gets resolved. In Idaho, they did the reverse, and did an injunction on a state ban that was counter to the interpretive guidance."

There's also a concern around digital health products and the data they collect. That data – coming from wearables and other consumer technology, largely – may fall outside of HIPAA because they're not covered entities, and engage directly with the consumer. A broader healthcare marketplace has arisen. 

"We don't have a set schema for regulating privacy in the U.S.," said Fisher. "There's a lot of tension in Congress about it."

With vastly differing responses from states – falling largely along red and blue lines – it's difficult for healthcare organizations to know how to proceed. And the confusion is likely to last a while, said Fisher.

"Company by company, the first thing to look at is how to structure your terms of use, and how to structure privacy policy," he said. "Those are mostly under your control."
 

Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com