Heading up the compliance efforts of one of the nation’s leading health care providers. Managing intellectual property strategy for a biotech startup leveraging Nobel Prize–winning gene-editing technology. Helping those experiencing homelessness get medical care on Los Angeles streets during the pandemic. Contending with private and public insurers on behalf of transgender people seeking coverage for life-changing, gender- affirming care.

In the dynamic field of health law, these are a few of the ways Minnesota Law grads are making a difference in an industry that accounts for some $3.8 trillion in spending, some 18% of the gross domestic product. Rapid change was the norm in health law and policies relating to access to care, insurance coverage, and treatment of conditions even before the pandemic further accelerated the pace over the past 18 months.

Minnesota Law alumni are helping digital health companies and health care providers meet growing demand for digital health tools and telemedicine services to engage and inform patients. They’re using data analytics to pursue better health, better care, and lower costs and to strengthen compliance pro- grams to protect patients and mitigate risks for providers.

Here are several of their stories. 

At the Cutting Edge of DNA

Gene-editing technology is cutting edge— literally. Understanding this process for “reading and writing the code of life” is essential to managing patent strategy for Rachel Herder ’11, vice president of intellectual property at Bay Area startup Mammoth Biosciences. 

Herder comes well prepared, having earned her Minnesota Law degree while also completing, through the U’s joint degree program, a doctorate in molecular cellular development biology and genetics working in the lab of Michael B. O’Connor, professor of genetics, cell biology, and development. 

“I use the science part of my brain just as much if not more than the legal side of my brain,” Herder says. “It’s important to understand the ins and outs of the technology down to the same level as a scientist.” 

That means having daily conversations with the scientists at Mammoth Biosciences, cofounded in 2017 by Jennifer Doudna. Doudna won the Nobel Prize in Chemistry in 2020 with Emmanuelle Charpentier for discovering CRISPR-Cas9 (short for clustered regularly interspaced short palindromic repeats). CRISPR is essentially a molecular pair of scissors, Herder says, which Mammoth Biosciences uses to make targeted edits to the genome to develop therapeutic products and as a type
of molecular search engine for diagnostic products.

Herder’s work supports Mammoth Biosciences’ mission to bring CRISPR “out of the lab and into everyday life.” The company quickly adapted its DETECTR platform to publish the first peer-reviewed CRISPR-based test for COVID-19 early in the pandemic. 

“I have a team I work with, and we spend our days thinking strategically about where the technology is going, what competitors might be doing, and how to best position the company to be successful,” Herder says. “IP strategy is kind of like a game of chess, because you have to be looking several moves in the future.” 

Herder, previously director of Penn State Law’s Intellectual Property Clinic and assistant professor of clinical law, joined Mammoth Biosciences in May 2020, moving cross-country during the pandemic. She began her career at a Bay Area law firm—Wilson Sonsini Goodrich & Rosati—doing IP work with companies building out CRISPR and other technologies before helping to open the firm’s Boston office.

The ethics of genomic editing became a concern after Chinese scientists edited embryonic humans, dubbed CRISPR babies, Herder says. She helped lead a company-wide book club that discussed ethical and other CRISPR-related issues raised in a recent book about Doudna. 

“The cofounders are committed to using the science
in an ethical way, and it is a constant conversation, which I think is appropriate,” Herder says. 

On the Pandemic's Frontlines 

Helping doctors navigate the regulatory maze to open pop-up COVID-19 testing sites across Los Angeles motivated Roma Patel ’15 to do more to respond to the pandemic. 

That meant leaving private practice at a boutique health care firm to become health care counsel in the University of Southern California’s Office of General Counsel. 

Patel, who began her new role in January 2021, provides legal support and counsel to USC’s three-hospital health system, university clinical research institutes, medical school, and clinical academic programs

It has been “fast and furious from day one,” she says.

When she arrived, the system was busy—amid a rising pandemic wave—setting up clinics to vaccinate up to 700 people a day.

“It was very humbling to be able to roll up my sleeves to help people who are really on the front lines and doing a lot of the real work, the real sacrificing,” Patel says.

Patel is legal counsel for the system’s Street Medicine program, which provides medical care to those experienc- ing homelessness. The program has grown from two
sites to five during the pandemic. She drafts service agreements, advises the team on structuring their activities to mirror traditional clinical standards, and makes sure providers are properly qualified.

With telemedicine use expanding during the pandemic, Patel counsels providers on the legal requirements of the states where patients live. Many states eased restrictions that, for example, require a provider to have a license in a patient’s home state to treat a resident there. Those waivers, however, typically end when a state rescinds its public health emergency orders. Patel gets a list of states to check each day and, when restrictions are back in place, she advises on the legal risk to providers of engaging in the practice of medicine in that state.

Patel advises executive and clinical leadership on developing initiatives, such as providing discounted mammograms to patients during Breast Cancer Awareness Month and free lodging to family members who can’t afford to pay for hotels when relatives undergo treatment or procedures. Those must be structured to fall within exceptions to healthcare fraud and abuse laws. She also advises on the creation of a statutorily estab- lished peer review body to manage clinical services rendered throughout the university.

Patel’s experience as a Minnesota Law student working in Mayo Clinic’s legal department fueled her desire to return to academic medicine, which she calls “the crossroads of all the best parts of health care.” 

Advocating for Transgender Clients

The gender-affirming care that Phil Duran ’00 helps transgender clients seek is “both figuratively and literally life-changing,” he says. But getting access to that care leaves some feeling “anxious and desperate” when private insurers or public programs deny coverage, adds Duran, who is director of advocacy, research, and education at Rainbow Health Minnesota, a St. Paul–based nonprofit serving the LGBTQ+ community. 

Duran stands largely alone in the state’s legal community in challenging those denials on behalf of transgender people. “You’re on the frontier, and that is both exciting and a bit scary sometimes, but more exciting than scary,” Duran says.Emerging issues for trans clients include care that minors experienc- ing gender dysphoria can receive, from hormone-suppressing medications for younger teens to mastectomies for older teens, Duran says. (Genital surgeries generally are not available to minors.)

Another concern, when insurance plans do cover gender-affirming care, involves disputes over what is medically necessary beyond genital surgeries and mastectomies. “Plans still balk at things like facial work and breast augmentation, which the prevailing treatment guidelines say can be medically necessary,” Duran says. Some 90% of Duran’s work involves advocating for access to health care for transgender clients. He’s often building on earlier cases of his that set precedent or led to policy changes.

The Minnesota Department of Human Services (DHS)—which administers the state’s public health care programs, Medical Assistance and MinnesotaCare—has a policy document that essentially explains how it covers gender-affirming care, Duran says. That exists because of a lawsuit Duran helped initiate as legal director at OutFront Minnesota, the state’s leading LGBTQ civil rights group, where he was legal director 18 years before he joined Rainbow Health Minnesota about four years ago. “The policy document itself contains problems, so we continue to engage DHS around how to resolve those,” Duran says. “Sometimes resolving those problems means taking on (Medical Assistance) appeals and fighting them out with DHS’ own judges, who will sometimes overrule the department and say, no, this has to be covered. You aggregate those decisions and say, look, your judges keep saying you’re wrong, maybe it’s time to change the policy.” 

Trans-related issues have been Duran’s primary focus since Minnesota legalized same-sex marriage in 2013.“For many years insurers and others looked at gender-affirming care as just crazy,” Duran says. “Or at best they might say that’s elective and cosmetic. There are pieces of that thinking that still exist and so we push against that.” 

Dealing with the Complications of Telehealth Law

The specter of contracting COVID-19—of being in the hospital on a ventilator and unable to voice preferences for medical care has driven enormous interest in advanced care planning, especially among those 65 and older. 

While the pandemic has boosted the use of telehealth for remote services, the question of whether patients can use electronic signatures on advanced care directives has become a major
issue nationally and in Colorado, according to Kristin Paulson ’10, chief operating officer and general counsel for the Denver-based Center for Improving Value in Health Care (CIVHC).

Colorado, like many states, requires patient and provider to be in the same room with a witness present to fill out a directive, Paulson says. That’s to ensure that nobody is pressuring the patient and that the doctor can determine the patient’s competency to make care decisions. “We are in the middle of really intense conversations nationwide,” Paulson says. “It’s a cutting-edge issue.”

The issue came to Paulson’s attention because she oversees CIVHC’s palliative care and advanced care planning programs, along with its data operations team, research positions, and data privacy and compliance. The nonprofit works to advance better health, better care, and lower costs through support services.

Using that data, CIVHC mapped high-risk populations to identify potential coronavirus hotspots, which the state used to design its vaccine rollout plan, says Paulson.

CIVHC administers a database with close to 1 billion identifiable health care claims for approximately 65 percent of individuals in Colorado with medical coverage, reflecting over 3.4 million lives. With the organization under state mandate to release data to researchers and providers, Paulson has had to immerse herself in health information privacy law and “a very specific niche branch of antitrust law” to balance enhancing competition without creating an opening for collusion or price-fixing.

Paulson expects telehealth visits, which took off as clinics largely closed amid stay-at-home orders, to stay part of a changing care delivery model. She tracks who uses telehealth services, for what specialties, and how use changes over time in CIVHC’s telehealth dashboard.

“That bridging of policy and data is what I wanted to do from the beginning, and I’ve been able to do since my 2L year,” says Paulson, who completed a master’s of public health through the U’s joint degree program. 

Keeping Up with Compliance

Building a robust health care compliance program—

with the goal of protecting patients and mitigating legal, regulatory, and reputational risk—is evolving from a manual task to a more robust, automated one under the leadership of Michelle Bergholz Frazier ’98, senior vice president and chief compliance officer at Advocate Aurora Health. One of the country’s largest not-for-profit health systems, Chicago- and Milwaukee-based Advocate Aurora Health has more than 75,000 employees and 24 acute-care hospitals and serves nearly 3 million patients annually.

Hospitals have had programs to comply with relevant rules and regulations since Frazier began practicing. But expectations regarding these programs have evolved, with the Affordable Care Act requiring that all providers adopt compliance programs as a condition of enrollment in Medicare and governmental expectations consistently growing over the years. 

Giving compliance programs a boost in rooting out erroneous and fraudulent claims and billing errors is the advent of electronic medical records and the use of data analytics to reveal insights in those records, says Frazier, who leads a 32-member compliance team. The team works closely with but separately from the system’s legal depart- ment to detect, prevent, and mitigate risks related to regulatory compliance. Frazier also teaches a course in health care fraud and abuse at Marquette University Law School. 

“Data analytics is certainly a new and important development in health care compliance,” Frazier says. “You can now run reports and flag where certain volumes are showing themselves as outliers. We never used to be able to do that. You’d have to just take random samples and manually review the records.” 

In addition to fraud and abuse, other risks have emerged during the global pandemic. While telehealth has improved access to remote care, it also has raised new cybersecurity and privacy concerns, Frazier says. Frazier is helping to ensure sure that appropriate controls are in place to address the increasing risk of ransomware attacks and the security of third-party vendors to whom the system provides data.

Traditional compliance work also is on the rise. With many employees working remotely, the expectation was that calls to Advocate Aurora Health’s compliance hotline would dip. But the opposite is true, Frazier says, with more staff members reporting concerns with such issues as privacy and billing practices.

“We attribute that to maybe more time and attention to things,” Frazier says. “We’re definitely seeing an uptick in people bringing issues forward.” 

Dealing with Digital Health Tools

Growing use of digital health tools is keeping Ryan Johnson ’99 busy counseling clients who are expanding their offerings, getting into the business, or investing in or acquiring companies developing innovative new technologies for patients and providers. 

Johnson, a Fredrikson & Byron shareholder, serves as outside general counsel to digital health companies and health care providers. Health care clients are increasingly adopting digital health tools, especially over the past five to seven years, to help improve quality of care, lower costs and enable patients to do a better job of managing their own health and wellness, Johnson says. 

Digital health encompasses tools ranging from telemedicine and remote monitoring to wellness and fitness trackers and diagnostic and therapeutic tools. “What’s common to all of these technologies and business platforms is their use of data, using technology and algorithms to collect, analyze, and process that data,” Johnson says, often using artificial intelligence and machine learning. “The trick is getting good data sets to well-crafted algorithms to make these technologies work.”

The COVID-19 pandemic accelerated the use of digital health tools as providers introduced or expanded telemedicine and remote monitoring services while regulations regarding payment under varying public health emergency declarations changed, says Johnson, whose advice includes helping clients get reimbursed for telemedicine service.

“People were hunkered down and telemedicine really took off in part because some of the regulatory road- blocks that were there before, like reimbursement limitations and state licensure requirements, were waived or put on pause. Those changes led to an explosion in telemedicine that helped prove that telemedicine and remote monitoring are critically important parts of the health care ecosystem.”

Johnson also is handling a number of transactions
as well as merger and acquisitions involving digital health in a strong year for investment and consolidation among those companies.

“I work with health companies, startups, and estab- lished players but also many health care providers who are incorporating digital health tools into their practices,” Johnson said. “I work with a number of providers who are also investing in digital health technology companies, not just contracting for the technology but also investing, taking an ownership stake in digital health companies because they can see the tremendous potential of some
of these technologies.” 

Todd Nelson is a Lake Elmo, Minnesota-based freelance writer.