Claire E. Castles

Even as an undergraduate studying philosophy and its offshoot, bioethics, Castles knew she wanted to work in life sciences law. So the Jones Day partner, planning ahead, focused in law school on a range of specialties beyond her chosen field. “I did not want to be myopic. I wanted to know general subjects for future issue spotting,” she said. And she knew that the health care sector covers a lot of ground. “I had a professor who called it a chaotic, dysfunctional patchwork of doctrines.”

Now Castles specializes in administrative and regulatory compliance advocacy for her health care and life sciences clients. That became especially useful when COVID-19 arrived and jolted the health care system into innovation. “People saw COVID chaos, but we saw areas where we needed to put pressure to achieve waivers and regulatory flexibility to get our clients where they needed to be.”

A chief example was Castles’ work for a health care system she prefers not to name to secure first-of-their-kind “hospital without walls” waivers from the Centers for Medicare and Medicaid Services. Prior to the pandemic, these programs were small research projects that tested technologies and care models designed to expand patients’ virtual access to highly skilled providers.

As a result of successfully expanding the program, hospitals can see more patients by providing hospital-level care outside the traditional setting. “They can bring a high level of sophisticated care to a patient’s home, but Medicare requires conditions of participation—for example nursing availability—and in order to achieve them at an alternative site of care, waivers were essential.” They were challenging to get. “We had to make comprehensive showings of how this new model would work.”

Underlying the challenges, Castles said, is the reality that regulatory frameworks are generally retrospective, concerned with what has worked in the past. “But if we’re going to advance American medicine and American science, we need innovations that don’t always fit into a backward-looking model.”

Achieving the waivers for hospital without walls programs was critical in the COVID-19 era. “This flexibility to provide patient care in an alternative setting is key to meeting the need and it gives hospital systems the opportunity to show CMS a new model, where the hospital comes to you.” Regulators have told her they’re pleased with the results, Castles said.

For client Valley Children’s Hospital in Madera County, Castles managed a variety of complex regulatory compliance and licensure issues, including response and triage solutions in responding to COVID-19 for pediatric patients who have cancer or await transplants.

“Again, this required a close review of the state waivers needed, in this case for the most vulnerable,” Castles said. “It was an honor. Health care law was what I wanted to do, and it has turned out to be better than I had hoped.”

--John Roemer