INTERVIEW

Addressing the opportunity gap Nathan Chomilo, MD, FAAP Department of Human Services

DHS recently restructured Medical Directorship to now include two individuals. Please tell us about this shift.

The move allows DHS to bring on regularly practicing physicians and providers who also have demonstrated experience in addressing health equity, health access, and better statewide integration of care. It is in line with the state’s commitment to address health disparities, particularly around substance use treatment, mental health access, and child and maternal health outcomes. Having a director focused on behavioral health and familiar with the nuances of care delivery as well as a director who is a practicing physician taking care of Medicaid patients regularly will allow these policy discussions to be more grounded in the impact on patients and their families.

What are some of the things that appealed to you about taking this new position?

Much of my early career focused on advocacy around early childhood, racial and health equity, and how health care systems can address the opportunity gap and structural racism. We have to shift how our health care system talks about disparities, how we structure payment and quality measurements, and how health care becomes a more just and equitable force. Medicaid plays a huge role by serving some of our most under-resourced communities. As one of the largest payers, it often sets policy that is followed by others.

Roughly 50% of my patient panel is served by Medicaid or MinnesotaCare. I had been interested in how I could utilize my experience with early childhood advocacy, Reach Out and Read Minnesota, and Minnesota Doctors Health Equity to help inform state policy—but I was not ready to move into a full-time policy position and give up my clinical practice. This opportunity aligned with many of my goals and existing efforts. In addition, our Governor, Lieutenant Governor, and Commissioner have been very clear about addressing racial disparities in Minnesota, recognizing the importance of early childhood, and making equity a focus across all efforts.

Leaders should seek “...” to understand first before being understood. “...”

What were some of your initial priorities and goals?

Prior to COVID, my goals were:

Working to address the racial and geographic disparities we see in our state, particularly regarding maternal health outcomes;

Continuing the work my predecessor pioneered on addressing the opioid crisis through the opioid prescribing improvement program; and

U sing Medicaid’s role throughout early childhood to better support the early childhood infrastructure and help decrease opportunity gaps that start as early as 18 months and lead to many of the disparities we see throughout life.

I also have taught and given several Grand Rounds about structural racism within medicine. I aim to help facilitate similar conversations within DHS and to support efforts to make DHS an agency that not only values equity but specifically anti-racism. The pandemic has allowed conversations about the importance of a racial equity lens to be applied to all policy discussions and for decisions to be accelerated.

Please tell us more about what your day-today activities are like now.

Before accepting this role, I split my time as an internal medicine hospitalist and a clinic pediatrician. My schedule was one week of hospital medicine and one week of clinic pediatrics. I’ve now moved to a casual position with the hospitalist group and I’m doing one week of clinic pediatrics, then one week with DHS.

As Medicaid medical director, my days are a mix of reading to stay abreast of the ever-changing policy landscape and medical literature; meetings with my DHS colleagues and with other state agency colleagues, health plans, provider groups, and patient advocates; and preparing and delivering talks to help inform the broader public about the work I do and the work of Minnesota’s Medicaid agency.

What surprised you most about your first six months?

The easy answer is COVID-19. There were few within public health or health care policy who saw in January the dramatic impact this would have. My initial plan was to spend a good chunk of the first six months getting to better understand our Medicaid agency functions at the state level, getting to know my colleagues at DHS and the work they are doing, and then starting to build toward my goals and the changes I hope to impact. COVID-19 accelerated some of my work and postponed other parts. It has been difficult to connect with and get to know all of the other leaders within the Medicaid agency due to both the difficulties of working from home and the extraordinary time and effort needed to address COVID-19—challenges that our whole agency has had to undertake.

What are some examples of how the pandemic has impacted your work or changed your priorities?

It has given me the platform to push for an “equity first” lens in all of our work earlier than I had

planned. One of my mentors gave me some great advice before I took this role: Leaders should seek to understand first before being understood. I continue to try to take that approach, but with COVID-19 I am more comfortable pushing first for a focus on equity, and for racial equity in particular.

I’ve heard the analogy that the COVID-19 response has been an exercise in building the airplane while you fly it. I’ve consistently pointed out that we need to build equity into the walls and core structure of our airplane rather than waiting to add it. As we are fundamentally restructuring parts of our health care system and society in ways unexpected just six months ago, it is important to recognize that we can’t simply go back to normal. Normal wasn’t working for so many communities in our state, so this moment requires a new normal committed to addressing the racial inequities that have persisted for much too long.

What are some of the DHS programs physicians should be more aware of?

I hope all physicians who care for children are aware of our Child and Teen Checkup program and the numerous benefits it provides for families to get childhood immunizations, developmental screening, and a healthy foundation.

I particularly want to highlight our integrated health partnerships (IHPs) and our integrated care for high-risk pregnancies (ICHRP). IHPs are an innovative way to support the delivery of health care by allowing providers to develop models that support Medicaid enrollees in the clinic/hospital as well as the social drivers that impact the health of enrollees and their communities. IHPs are in their second iteration (IHPs 2.0) and there are currently 25 IHPs throughout the state addressing issues such as food and housing insecurity, as well as transportation barriers. We continue to explore and develop this model and I am interested in how this can help us address some of the social drivers of health and decrease some of the racial and geographic disparities.

Our ICHRP program is an innovative way to address the maternal health outcome disparities we’ve seen in African American and American Indian populations in Minnesota. It is a communityled and community-driven model. DHS entrusts the communities, who know what resources they need, to help identify the problem and co-create the structure for them to be the stewards of those resources. This shared power is often where talk about equity and addressing structural racism has lagged in big health care systems. This model could be scaled up to be the standard of care for all Black and American Indian mothers in Minnesota, as well as an example of how we can share power with communities to address some of the deep inequities stemming from structural racism.

Lastly, DHS helps our neighbors in need of housing, income, childcare, and nutrition support. These social drivers of health greatly impact our patients’ overall health, so I hope that physicians are aware of these resources and how to connect their patients to them, especially given the economic and health impact of COVID-19.

Nathan Chomilo, MD, FAAP, is medical director for Medicaid and MinnesotaCare at the Minnesota Department of Human Services. A pediatrician and internist, Dr. Chomilo is a founding member of Minnesota Doctors for Health Equity, a statewide coalition of physicians. He serves as medical director for Reach Out and Read, Minnesota, and as an Early Childhood Champion for the Minnesota chapter of the American Academy of Pediatrics.

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3 Professional liability in a pandemic from cover

such as hydroxychloroquine were touted as cures, but then proved to be disappointing. Remdesivir has been approved by the FDA with promising but minimal data and is already in short supply. Even more vexing is the lack of family support in the clinics and hospitals. The virus has separated our most vulnerable patients—those least likely to provide a clear medical history—from their families and strongest advocates, leaving physicians without crucial information that could lead to a more accurate diagnosis. Telemedicine, the golden child of the pandemic, will ultimately benefit all of us, but it is difficult to fully evaluate a patient when they don’t have the right online equipment and are unable to focus the camera for a decent exam.

These challenges are unprecedented. Without malpractice protections, this time is ripe for litigation. The Health Affairs blog reported in May that several claims of medical negligence had already been filed for not prescribing hydroxychloroquine and for delays in responding to patients’ needs because of the time it took to put on personal protective equipment (PPE). This is not an easy time to be a doctor, but it will be even worse if Minnesota does not follow the lead of states like New York, Kansas, and Iowa to protect our hospitals and physicians from unfair medical malpractice litigation.

Before COVID-19 hit

Prior to the pandemic, malpractice was ramping up. Malpractice cases are measured both on frequency, the number of cases filed; and severity, the size of the settlement. In most of the country, both frequency and severity

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have been increasing over the past two years. In 2018, the largest medical malpractice case was awarded $190 million against a Maryland OB-GYN. Not to be outdone, 2019 saw an even larger judgement of $229 million. This increase in the severity of jury awards has led Lloyd’s of London, the premier insurance marketplace, to disincentivize insurance companies from providing insurance for medical malpractice.

Although many groups and hospitals are self-insured, a second form of insurance, called re-insurance, is required to help cover large losses. Due to these increasingly large settlements, this is becoming more expensive and difficult to obtain, ultimately raising physicians’ malpractice insurance rates. Minnesota is no exception. Over the past few years, we have had numerous $6–8 million settlements, as well as multiple $20 million+ settlements— and the trial bar is taking notice. Top plaintiff lawyers from throughout the country are flying into Minnesota to try cases in hopes of high settlements. In a recent Health Affairs review, Minnesota’s medical malpractice protections were given a “D” grade, beating out only six other U.S. states.

Current examples

It may seem that hospitals and physicians are riding a wave of good will from the public. But remember, lawsuits are often filed several years after the encounter, and memories are short when the patient outcome is heartbreaking. Furthermore, we rely on patient relationships for both diagnoses and compliance with treatment. Currently, many visits are relegated to telemedicine, where relationships are harder to foster. When visits are in-person, the physician is behind a shield, mask, goggles, gown, and gloves, making them literally unrecognizable.

Two years from now, how many lawsuits will there be for delayed diagnoses of cancer, cellulitis, or heart failure due to the current inability to do a simple exam? How many suits will be filed due to delayed surgery that allowed the progression of a disease that may have been suspected prior to the surgery but not confirmed? Even a skin biopsy was considered “nonessential” surgery when Gov. Tim Walz banned such procedures last spring. When the state allowed for this non-essential procedure to be reinstated, there was a three-month back-up in procedures.

And what about the physician who encouraged a patient to come in for an in-person visit, only to have the appointment delayed by the 5–8 day turnaround in COVID testing, during which time the disease advanced? The protocols for in-person visits and procedures change monthly, if not weekly, and it will be hard to pinpoint in hindsight where we were in this crisis at the time the suit is eventually filed.

Get involved

Physicians need to take action as soon as possible to remedy this situation while we have public understanding. On March 24, 2020, U.S. Secretary of Health and Human Services Alex Azar issued a letter asking all state governors to provide civil immunity from medical liability for health care workers treating COVID-19. Complete immunity has not come to fruition in most states, but malpractice protections have been put in place in over half of the country. Most importantly, these protections have frequently covered all care rendered during the pandemic, not just care given to patients with COVID-19.

Frustratingly, no legislation has been introduced in Minnesota. Iowa’s recent malpractice reform law offers a good framework for future legislation in this state. Five key aspects of Iowa’s law:

Actual medical expenses. The plaintiff can only sue for medical expenses our families. Throughout this, we have been furloughed, laid off, or had actually paid. When patients receive a bill, it is often significantly discounted our pay cut significantly. This is not an easy time to be a doctor. But we are by their insurance. In other words, a physician may send a bill for $250, but “essential workers,” and we are proud to serve our communities. only receive the negotiated insurance rate of $120. This law would allow the However, the cases tried for delayed procedures, inadequate informed plaintiff to be reimbursed only for the negotiated rate that was actually paid. consent, and missed diagnoses over telemedicine will all be tried in court

Catching COVID-19. This part of the law sets three to four years from now. Of course, we will all a high burden of proof if arguing that COVID-19 remember the pandemic, but time will bring a clarity was contracted in a hospital or clinic, as opposed to to our actions that we don’t have now. Malpractice another setting. cases will be tried with information we do not have Prescribing/not prescribing medications. The Iowa law protects physicians’ ability to prescribe or not prescribe medications based on their clinical judgement. At the beginning of the pandemic, many Several claims of medical negligence had already been filed for not prescribing hydroxychloroquine. yet. Each physician goes to work under unusual and challenging circumstances. We all feel overwhelmed. But take the time to both call and email your legislators. Then ask your partners, co-workers, of us were asked to prescribe hydroxychloroquine family, and friends to do the same. There is power in with an azithromycin chaser. We now know that numbers. Legislators will notice. Now may not be an was dangerous, but at the time, there were many easy time to be a doctor, but if we advocate for our complaints lodged with our organizations for our profession, we may not have to relive it in court three failure to provide these medications. Remdesivir is currently in short supply; years from now. Iowa’s law protects ICU docs who can’t give it because they don’t have it.

Delayed diagnosis. The law protects physicians from liability for any Carolyn McClain, MD, is an emergency physician working in St. Louis Park injury or death alleged to have been caused by a cancellation, delay, or denial and Hutchinson. She is on the Board of Directors of the Minnesota Medical of care resulting from a governmental order, directive, guidance, or policy Association and is currently performing a fellowship with the Medical that was part of the state’s response to COVID-19. Professional Liability Association in Washington, D.C.

“Reckless or willful misconduct.” During the pandemic, in order for malpractice to occur, there must be proof of “reckless or willful misconduct.” Although this standard will not prevent lawsuits, it is a much harder standard to prove. If you remove the wrong organ during surgery, you are not protected, but if you have a rare but known complication of surgery, this is a difficult standard to overcome.

In addition to the protections offered in Iowa’s law, I would argue that we should include protections for diagnoses delivered through telemedicine during the pandemic, as this was implemented before full-scale studies on safety and efficacy could be performed.

Across the country

Malpractice reform has been gaining national traction. For example, the Good Samaritan Act was broadened to protect any physicians who volunteered, without pay, to treat patients with COVID-19. Although important, this does not help those of us who were concurrently working in our own communities.

More recently, the Coronavirus Provider Protection Act (H.R.7059) was introduced by Representatives Phil Roe, MD (R-TN), and Lou Correa (D-CA). This act is much narrower than the Iowa law, but does offer protection from delayed/missed diagnoses due to the public health emergency, as well as offering the standard of gross negligence, which is similar to the “reckless or willful misconduct” standard. If passed, these protections would be in place during the pandemic and for a limited period afterward.

Closing thoughts

Now is the time to argue for reform. As physicians, we have stepped up to the plate. We put on our PPE, we use telemedicine, we advocate to the best of our abilities that each of our patients’ health issues are “essential,” and we ultimately take care of patients at great personal risk to ourselves and

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3 Biosimilars vs. biologics from cover From lab to consumer to replace existing medications, biologic drugs are priced higher. Because of 5,000 drugs that enter preclinical testing, only five make it to human their costs, biologics have represented almost 93% of the net drug spending testing. And only one of those may actually get approved. growth since 2014, according to one analysis. The FDA approval process for biologics

Generics. Few steps are needed to make includes pre-clinical testing (average length: 3.5 a generic drug. The generic drug’s active years), phase 1 clinical trials (averaging one year), ingredient is the same as the brand-name phase 2 clinical trials (averaging two years), product, and must be approved by the FDA. The paperwork is easier than for a new/novel drug application (NDA), and generic drugs are Of any 5,000 drugs that enter preclinical testing, only five make it to human testing. phase 3 clinical trials (averaging three years), and FDA review of the new drug application or biologic license application (up to 2.5 years) easier to produce. Generics are often produced before the product is launched. by outside companies, but some manufacturers The FDA does have programs that allow for now release their own branded generics (e.g., expedited reviews—accelerated, priority, fast Mylan’s authorized generic version of its track, and breakthrough therapy—that target EpiPen). Generics grew in popularity due to different parts of the review process. Cancer their large cost savings. Could this model apply to biosimilars? drugs dominate all four categories. Still, for many drugs, it can take an

Biosimilars. A biosimilar is defined as a medication that is highly similar, average of 12 years from lab to medicine cabinet. but not structurally identical, to an existing FDA-approved biologic. These The biosimilar approval process is arduous as well. Since 2015, the FDA less-expensive biosimilar medications—which, according to FDA reviews, has approved 24 biosimilars for nine reference biologics. But only 12 of those have no clinically significant differences from their reference drugs—offer had reached the marketplace by the end of 2019. And those biosimilars have potential savings for both health plans and consumers. To put this in small market penetration. perspective, industry analysts project near-term savings of at least $54 billion Drug manufacturers develop thousands of ideas for drugs. But out of any with only a 3% conversion from biologics to biosimilars. Two types of biosimilars The Biologics Price Competition and Innovation Act (BPCIA) of 2009 created two approval categories: 1) biosimilars, which are highly similar to and have no clinically meaningful differences from an existing FDAapproved reference biologic; and 2) interchangeable biosimilars, which are biosimilars that meet additional requirements under the BPCIA. Manufacturers of an interchangeable biosimilar must demonstrate that switching between the interchangeable and reference product in a single patient would not increase the risk of safety issues or diminished efficacy compared with using the reference biologic product alone—a much higher bar to meet, and one that many commentators consider to be out of reach.

The marketplace currently has its focus on the first biosimilar approval pathway. These are the biosimilars that are currently approved and on the market.

Initial impact

The 12 biosimilars launched in the U.S. represent just a fraction of the potential. The market has been cautious, looking for more regulatory guidance and support. The FDA’s Biosimilar Action Plan of 2018 (https:// tinyurl.com/mp-fda-biosimilars) has many sound elements, but progress has been slow.

Unfortunately, critics accuse reference biologic manufacturers of using several tactics to inhibit competition with biosimilars:

• Patent lawsuits that keep other manufacturers from entering the market.

• “Pay for delay,” under which a biologic manufacturer will pay a biosimilar manufacturer to stay out of the market for an agreed-upon period of time, just as they pay manufacturers of generics to delay new launches.

• Increasing rebate discounts on reference drugs to make them more In some ways, we face the same resistance with biosimilars today. Except competitive with biosimilars. now, instead of switching to generics for treating high cholesterol or high • Misinformation campaigns about patient reactions to biosimilars. blood pressure, we’re asking consumers to switch from a biologic to a

These tactics are getting push back. In February 2020, the Federal Trade Commission (FTC) and FDA announced new Brand-name biologics: Still preferred efforts to prevent these anti-competitive business under most benefit designs practices, and to better support a competitive A Journal of the American Medical Association market for biological products. (JAMA) study (https://tinyurl.com/mp-benefit

FTC Chairman Joseph Simons said, “We’re Physicians can still designs) looked at benefit designs for 17 major not only educating about biosimilars, but we’re choose a biosimilar, health plans in 2020. The plans represented re-educating to counter the misinformation. even if it’s not “preferred.” 60% of Americans covered by commercial Practices in biologics markets are delaying health plans. the availability of biosimilar products, More than 500 separate coverage decisions thereby depriving patients of the benefits linked to biosimilars were made across those health of competition, including lower prices and plans. Ten of those 17 health plans chose not to increased innovation. The FTC is committed offer preferred coverage for biosimilars at all. Just to continuing to enforce the antitrust laws in health care markets, including two health plans made biosimilars a preferred choice half of the time or more. those for biologics and biosimilars.” Potential savings Echoing generics Here are two specific cost-saving opportunities for biosimilars—both A lot of consumers didn’t want generic drugs in the 1990s. Then the FDA, in oncology: health plans, employers, and pharmacy benefit managers (PBMs) pitched in Neutropenia. Five of the biosimilars launched in the United States are with education campaigns stressing that generic drugs delivered the same in one drug class, called granulocyte-colony stimulating factor (G-CSF). quality as brand-name drugs. biosimilar for treating cancer. It’s a bigger decision.

Biosimilars vs. biologics to page 324

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