MINNESOTA
AUGUST 2020
PHYSICIAN
THE INDEPENDENT MEDICAL BUSINESS JOURNAL
Volume XXXIV, No. 05
Biosimilars vs. biologics An expanding source of cost savings BY JEREMY WHALEN, PHARMD, BCOP
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ising drug costs are a big part of today’s health care crisis. Consumers, physicians, and health plans all strive to contain consumer prices, while manufacturers continue to develop innovative pharmaceuticals and steer them through development, testing, and approval. That process can be arduous for all categories of drugs— including biologics and generics—but some commentators now see promise in “biosimilar” medications, seeing them as the path to reduce costs while ensuring effective treatment.
Biosimilars to biologics as generics to branded products?
Professional liability in a pandemic Risk management concerns BY CAROLYN MCCLAIN, MD
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his is not an easy time to be a doctor. To care for patients, we must wear N-95 masks, welder’s helmets, gowns, and several sets of gloves—and for the first few months of the pandemic, we didn’t have enough. As a result, surgeries, biopsies, mammograms, and other critical health care procedures and consults were delayed. Heart attacks, strokes, and cancer have persisted, but have fallen under the shadow of COVID-19. The physician and patient experience is far from optimal. ICU capacity is always at risk. The research on treatment for this disease is in its infancy. Drugs Professional liability in a pandemic to page 104
Biologics. While most drugs are chemically synthesized, biologics are derived from living entities. They can be composed of sugars, proteins, nucleic acids, or cells and tissues, according to the FDA. These drugs can be isolated from natural sources, or may be produced in the laboratory, as in the case of gene-based and cellular biologics. Invented to treat complex, difficult conditions and Biosimilars vs. biologics to page 124
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AUGUST 2020 MINNESOTA PHYSICIAN
NNESOTA’S MI
AUGUST 2020
|
REQUEST FOR NOMINATION
Volume XXXIV, Number 5
COVER FEATURES Professional liability in a pandemic
H
Risk management concerns
Biosimilars vs. biologics An expanding source of cost savings
By Carolyn McClain, MD
By Jeremy Whalen, PharmD, BCOP
DEPARTMENTS CAPSULES .................................................................................. 4 MEDICUS.................................................................................... 7 INTERVIEW .................................................................................. 8
L RS EA IN F L L T H U E N T I AA D E C A R E LE
Publication Date: November 2020
Nominate the 100 Most Influential Health Care Leaders In our November 2020 edition, Minnesota Physician will profile 100 of our state’s most influential health care leaders. In a format featuring photos, bios, and quotes, we will highlight the men and women most responsible for making Minnesota a global model for health care delivery.
Addressing the opportunity gap
These individuals will represent every aspect of the industry: physicians,
Nathan Chomilo, MD, FAAP Department of Human Services
business executives, political leaders, policy analysts, etc.
PUBLIC POLICY........................................................................... 14
you know anyone within your organization you feel should be considered,
We invite you, our readers, to participate in this recognition process. If please fill out the form below and mail it or submit online (www.mppub.
Addressing a systemic problem
com/top100.html) or via e-mail (comments@mppub.com) prior to
Why we need a “Patient’s Choice” law
September 25. We welcome your input and participation in making this
By Charles E. Crutchfield III, MD PUBLIC HEALTH.......................................................................... 18
list as comprehensive and meaningful as possible.
COVID-19 in Greater Minnesota Addressing structural inequities
I would like to nominate the following individual(s):
By Charlie Mandile
PUBLIC HEALTH.......................................................................... 20 Education as health
Nominee’s name (please include all advanced degrees):
A partnership that is changing lives
Nominee’s title:
By Bruce Cantor, MD, MS
Nominee’s affiliation:
WOMEN’S HEALTH..................................................................... 24 Menopause
Brief description of the nominee’s work and influence:
A multidisciplinary approach By Rachel S. Cady, MD, FACOG
OPHTHALMOLOGY..................................................................... 28 Refractive surgery New options for patients By Jessica Heckman, OD
Nominator information (strictly confidential):
Name: Phone #:
www.MPPUB.COM PUBLISHER
________________________________________________________________________
Mike Starnes, mstarnes@mppub.com
EDITOR___________________________________________________________Richard Ericson, rericson@mppub.com ART DIRECTOR______________________________________________________ Scotty Town, stown@mppub.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is PO Box 6674, Minneapolis, MN 55406; email comments@mppub.com; phone 612.728.8600;. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.
Email: Send to: Minnesota Physician Publishing: Top 100 PO Box 6674, Minneapolis, MN 55406 Online form: www.mppub.com/top100.html Email: comments@mppub.com For more information, call 612.728.8600
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MINNESOTA PHYSICIAN AUGUST 2020
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CAPSULES
MDH issues guidance on long-term care visits New guidance from the Minnesota Department of Health (MDH) intended to balance COVID-19 safety and visitation restrictions with the well-being of residents in long-term care facilities is now in effect. Since March, visitor restrictions have been in place in long-term care settings to prevent the spread of the disease. However, balancing these restrictions with the well-being of residents is an urgent priority to limit unintended harms of social isolation. The new guidance states that the primary consideration for facility visitation decisions should be whether there has been an exposure in the facility from a COVID-19 case in a resident, staff, or visiting service provider within the past 28 days. It also provides a series of factors facility management can use to evaluate their COVID-19 risk, and
details a process for opening up to a greater level of visitation when it is deemed appropriate to do so. Risk factors for facility management also include case incidence in the surrounding community, facility size, and the extent to which staff at the facility are working at other LTC facilities. The guidance states that facilities should develop testing plans with baseline facility-wide testing within a window of time before or after opening, depending on facility type. Facilities should refer to existing MDH guidance on the appropriate use of testing in long-term care facilities. A key factor that determines the testing needed is whether the facility is a nursing or assisted living-type facility. Nursing home residents are considered to be at a higher risk of contracting and dying from COVID-19, which is why they must conduct facility-wide testing. Assisted living type-facility residents are
still at high risk, and so facility-wide testing is recommended.
Medicare to implement simplified coding and documentation guidelines Major modifications are coming to the coding, documentation, and payment of evaluation and management (E/M) services for office visits as Medicare has signaled its intention to implement finalized guidelines and payment rates on Jan. 1, 2021. “The AMA appreciates that CMS will implement significant increases to the payment for office visits, based on recommendations on resource costs from the AMA/Specialty Society RVS Update Committee (RUC),” said American Medical Association President Susan R. Bailey, MD. “Unfortunately, these office visit payment increases, and a multitude of other new CMS proposed payment increases, are required by statute to
be offset by payment reductions to other services, through an unsustainable reduction of nearly 11% to the Medicare conversion factor. For this reason, the AMA strongly urges Congress to waive Medicare’s budget neutrality requirement for the office visit and other payment increases. Physicians are already experiencing substantial economic hardships due to COVID-19, so these pay cuts could not come at a worse time.” Bailey said that reducing documentation overload and providing physicians more time with patients was the fundamental purpose of overhauling the E/M office visit guidelines. Key elements of the E/M office visit overhaul include: • Eliminating history and physical exam as elements for code selection. While significant to both visit time and medical decisionmaking, these elements
MEDICAL MALPRACTICE ATTORNEYS
Angela Nelson
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AUGUST 2020 MINNESOTA PHYSICIAN
Ryan Ellis
Marissa Linden
Jennifer Waterworth
CAPSULES
alone should not determine a visit’s code level. • Allowing physicians to choose whether their documentation is based on medical decision-making (MDM) or total time. This will recognize the work involved in non-faceto-face services like care coordination. • Modifying MDM criteria to move away from simply adding up tasks to focus on tasks that affect the management of a patient’s condition. While CMS recognized the increases in the payment bundles for maternity care and a few other select services, the visits within the surgical global payment bundle remains unchanged. The AMA strongly supports CMS adoption of the office visit changes and continues to urge CMS to incorporate the office visit payment increases into the global surgery packages.
New mental health hold provisions now in effect During the first special session of the Minnesota Legislature, lawmakers passed a comprehensive health and human services policy bill that included provisions impacting the implementation of several state human service programs. Included in that bill, now Chapter 2 of special session law, were revisions to Minnesota’s civil commitment statutes—a longtime priority of mental health advocates including NAMI Minnesota—including the laws related to mental health transport holds and emergency holds (often referred to as “72-hour holds”). This language can be found in Section 33, Subdivisions 2 and 3. Under the new Minnesota law, statutory language related to transport holds and emergency holds was revised to increase clarity,
revise definitions, and bring the law in line with the current mental health system. Revisions included expanding the scope of health care professionals who could order a transport or emergency hold, clarifying that a transport hold issued by a health care professional is sufficient authority for law enforcement to transport a person with a mental illness, and expanding the authority of health care facilities to provisionally discharge patients on an emergency hold (an authority that was previously limited to the commissioner of human services). The new law also limits the duration of a transport hold to 12 hours, while the prior law included no time frame.
University opens clinical trial for new treatment of COVID-19 A patient with COVID-19 and lung failure at the University of Minnesota is the first to be treated in the U.S. under a new FDA-approved clinical trial to determine the safety and effectiveness of mesenchymal stem cells (MSCs). This new treatment—for some of the sickest COVID-19 patients—is aimed at halting the intense inflammatory response of the body, referred to as a “cytokine storm.” The cytokine storm is caused by the body’s immune response to the coronavirus. If unchecked, it can cause extensive organ damage, most often lung failure. The study is led by David Ingbar, MD, a critical care and pulmonary physician at the M Health Fairview University of Minnesota Medical Center (UMMC) and director of the University of Minnesota Medical School’s Division of Pulmonary, Allergy, Critical Care and Sleep Medicine. He also served as the President of the American Thoracic Society, the largest U.S. critical care and pulmonary organization.
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CAPSULES
The study, led and developed by the team of researchers at the University of Minnesota, will include other academic centers across the U.S. The multisite study is open now at M Health Fairview UMMC and Bethesda Hospital, which was previously converted into the state’s first dedicated COVID-19 care facility. To determine the benefit of MSCs, patients will be randomized to receive three doses of MSC 48 hours apart or a placebo solution.
New cases of severe lung injuries associated with vaping suspected The Minnesota Department of Health (MDH) recently sent an alert to health care providers in response to reports of 11 suspected cases in Minnesota of severe lung injuries associated with vaping. The vaping cases in Minnesotans ages 14- to 46-years-old occurred in
June and July, with a median age of 18 years. Diagnosis was made more difficult because the symptoms of the disease can be similar to those of COVID-19. All 11 cases resulted in hospitalizations with some requiring intensive care, including being placed on ventilators. “We want providers and the public to be aware of the continued dangers of vaping products, and the possibility of lung injuries presenting as COVID-19,” said Minnesota Commissioner of Health Jan Malcolm. “As we continue to investigate the causes of the lung injuries, we encourage people to take advantage of our free Quit Partner resources to help with quitting vaping.” The patients sought care for symptoms similar to severe COVID-19 infection, including cough and shortness of breath. However, testing found the patients were not infected. Patients also
responded to systemic steroid therapy, the treatment for e-cigarette or vaping product use-associated lung injury (EVALI). The patients said they had a history of vaping. Most reported vaping THC or tetrahydrocannabinol, the principal and most active ingredient in marijuana. Some reported using nicotine-based products. There are similar reports of a resurgence of lung injury cases in California.
Davis welcomes new health care tenants Davis has announced new tenants at its CityPlace II and CityPlace III facilities. CityPlace II is a 42,000-squarefoot Class A multi-tenant medical building designed by Synergy Architecture Studio. The entire first floor is home to Shriners Children’s, a nonprofit organization that provides specialized pediatric orthopaedic
services. Their new space features what Shriner’s describes as “hightech” and “high-touch” technology to benefit their patients. Adrefis & Toppin Women’s Specialists have also moved their clinic into CityPlace II. They are a fullrange obstetrics and gynecology practice with more than 20 years of experience. They offer holistic, individualized treatment from a team of all-female physicians. CityPlace III, a 15,000-squarefoot single-tenant building, is home to Midwest ENT. Midwest ENT offers multiple ear, nose, and throat services, including hearing aid systems, allergy and asthma treatment, and facial plastic surgery and aesthetic skin care. CityPlace is home to more than 200 health care-related businesses in Woodbury.
V Alzheimer’s is now an approved condition V
HAVE YOU REGISTERED WITH THE MINNESOTA MEDICAL CANNABIS PROGRAM? Registration can be done online; there is no fee and it takes only a few minutes. Visit the registry website: mn.gov/medicalcannabis Your account will provide access to medical cannabis purchasing information from patients you certify. Once you are registered, you will be able to certify patients with a variety of conditions, including: • Cancer, Glaucoma, Tourette Syndrome, HIV/AIDS, and ALS
• Inflammatory bowel disease, including Crohn’s disease
• Seizures, including those characteristic of Epilepsy
• Terminal illness, with a probable life expectancy of less than one year
• Severe and persistent muscle spasms, including those characteristic of MS
• Intractable Pain
• Obstructive sleep apnea
• Post-Traumatic Stress Disorder
• Alzheimer’s
• Autism
Cannabis Patient Centers are now open to approved patients in Minneapolis, Eagan, Rochester, St. Cloud, Moorhead, Bloomington, Hibbing, and St. Paul.
OFFICE OF MEDICAL CANNABIS (651) 201-5598: Metro (844) 879-3381: Non-metro P.O. Box 64882, St. Paul, MN 55164-0882 health.cannabis@state.mn.us
Many patients have reported improvement in their health status from medical cannabis — some describing dramatic improvements. Smoking cannabis is not allowed under the program. Visit our website for educational resources about cannabinoids and the endocannabinoid system and for scientific literature on the efficacy of medical cannabis in treating certain conditions.
See our website for a detailed first year report. mn.gov/medicalcannabis
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AUGUST 2020 MINNESOTA PHYSICIAN
MEDICUS
Kris Ann Schultz, MD, a pediatric oncologist and hematologist with Children’s Minnesota, has been named inaugural holder of the Pine Tree Apple Tennis Classic Endowed Chair in Cancer and Blood Disorders Research in recognition of her clinical and academic accomplishments in the field of childhood cancer research, as well as her roles as principal investigator for two registries at Children’s and a grant funded by the National Cancer Institute/National Institutes of Health. Two physicians—who happen to be married to each other—have joined CentraCare. Olivia Lee, MD, MBA, will practice in CentraCare’s Urology Clinic, where she will specialize in endoscopic, laparoscopic, robotic, and open surgeries. Previously a physician with Kaiser Permanente in California, her special clinical interests are management of kidney, prostate and bladder cancers, kidney stones, BPH, prosthetics, and urinary incontinence. Dr. Lee’s spouse, Gilbert Cadena, MD, will serve as a neurosurgeon in the Neurosciences Brain & Spine Center. A member of the Congress of Neurological Surgeons, the American Association of Neurological Surgeons, and the North American Skull Base Society, Dr. Cadena’s special clinical interests include brain tumors, skull base tumors, brain aneurysms, carotid occlusive disease, and neuroendoscopy.
Osmo Vänskä // M U S IC DIRECTOR
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Patrick Hughes, MD, has joined St. Luke’s Emergency Department. Dr. Hughes received his medical degree from the Medical College of Wisconsin in Milwaukee. He then completed his residency and an emergency cardiology fellowship at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Prior to joining St. Luke’s, Dr. Hughes was an attending physician at Beth Israel Deaconess Medical Center. Denisse Broadbent, MD, who specializes in pediatrics, has joined the Essentia Health St. Joseph’s–Baxter Clinic. Originally from Guayaquil, Ecuador, Dr. Broadbent earned her medical degree at the Universidad Catolica Santiago De Guayaquil in Ecuador. She completed her residency in pediatrics at El Paso Children’s Hospital at Texas Tech University Health Sciences Center in El Paso, Texas. A native Spanish speaker, she welcomes bilingual patients.
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MINNESOTA PHYSICIAN AUGUST 2020
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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.
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.
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.
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.
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AUGUST 2020 MINNESOTA PHYSICIAN
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.
“...” should seek Leaders to understand first before being understood. “...”
What are some of the things that appealed to you about taking this new position?
Please tell us more about what your day-today activities are like now.
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 • Using 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
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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3Professional 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
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.
Helping Beautiful Things Emerge From Hard Places
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. TWO CENTERS.
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AUGUST 2020 MINNESOTA PHYSICIAN
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 actually paid. When patients receive a bill, it is often significantly discounted by their insurance. In other words, a physician may send a bill for $250, but only receive the negotiated insurance rate of $120. This law would allow the plaintiff to be reimbursed only for the negotiated rate that was actually paid.
our families. Throughout this, we have been furloughed, laid off, or had our pay cut significantly. This is not an easy time to be a doctor. But we are “essential workers,” and we are proud to serve our communities.
However, the cases tried for delayed procedures, inadequate informed 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 yet. Each physician goes to work under unusual and Several claims of medical Prescribing/not prescribing medications. The negligence had already challenging circumstances. We all feel overwhelmed. Iowa law protects physicians’ ability to prescribe or been filed for not prescribing But take the time to both call and email your not prescribe medications based on their clinical hydroxychloroquine. legislators. Then ask your partners, co-workers, judgement. At the beginning of the pandemic, many family, and friends to do the same. There is power in of us were asked to prescribe hydroxychloroquine numbers. Legislators will notice. Now may not be an with an azithromycin chaser. We now know that easy time to be a doctor, but if we advocate for our was dangerous, but at the time, there were many profession, we may not have to relive it in court three complaints lodged with our organizations for our years from now. failure to provide these medications. Remdesivir is currently in short supply; 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 injury or death alleged to have been caused by a cancellation, delay, or denial of care resulting from a governmental order, directive, guidance, or policy that was part of the state’s response to COVID-19.
Carolyn McClain, MD, is an emergency physician working in St. Louis Park and Hutchinson. She is on the Board of Directors of the Minnesota Medical Association and is currently performing a fellowship with the Medical 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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3Biosimilars vs. biologics from cover to replace existing medications, biologic drugs are priced higher. Because of their costs, biologics have represented almost 93% of the net drug spending growth since 2014, according to one analysis.
From lab to consumer Drug manufacturers develop thousands of ideas for drugs. But out of any 5,000 drugs that enter preclinical testing, only five make it to human testing. And only one of those may actually get approved.
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. phase 3 clinical trials (averaging three years), Of any 5,000 drugs that The paperwork is easier than for a new/novel and FDA review of the new drug application enter preclinical testing, only drug application (NDA), and generic drugs are or biologic license application (up to 2.5 years) five make it to human testing. 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 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.
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• Increasing rebate discounts on reference drugs to make them more competitive with biosimilars. • Misinformation campaigns about patient reactions to biosimilars. These tactics are getting push back. In February 2020, the Federal Trade Commission (FTC) and FDA announced new efforts to prevent these anti-competitive business practices, and to better support a competitive market for biological products.
In some ways, we face the same resistance with biosimilars today. Except now, instead of switching to generics for treating high cholesterol or high blood pressure, we’re asking consumers to switch from a biologic to a biosimilar for treating cancer. It’s a bigger decision.
Brand-name biologics: Still preferred under most benefit designs A Journal of the American Medical Association (JAMA) study (https://tinyurl.com/mp-benefitdesigns) looked at benefit designs for 17 major health plans in 2020. The plans represented 60% of Americans covered by commercial health plans.
Physicians can still FTC Chairman Joseph Simons said, “We’re choose a biosimilar, not only educating about biosimilars, but we’re even if it’s not “preferred.” re-educating to counter the misinformation. Practices in biologics markets are delaying 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.” Echoing generics A lot of consumers didn’t want generic drugs in the 1990s. Then the FDA, health plans, employers, and pharmacy benefit managers (PBMs) pitched in with education campaigns stressing that generic drugs delivered the same quality as brand-name drugs.
Potential savings
Here are two specific cost-saving opportunities for biosimilars—both in oncology: Neutropenia. Five of the biosimilars launched in the United States are in one drug class, called granulocyte-colony stimulating factor (G-CSF). Biosimilars vs. biologics to page 324
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PUBLIC POLICY
Addressing a systemic problem Why we need a “Patient’s Choice” law BY CHARLES E. CRUTCHFIELD III, MD
Here at home
n a recent article, “Institutional racism in medicine: It’s time for changes,” published in the July 2020 edition of Minnesota Physician (http:// mppub.com/mp-c1-0720.html), members of the Minnesota Association of Black Physicians offered a first-hand look at the experiences and challenges faced by Black and other physicians of color. Institutional racism in medicine, and in every part of society, is much deeper and more complex than what can be illustrated by individual experience. In health care it also has significant impact on issues such as access, policy, and reimbursement. It is an insidious concept that hides so plainly in sight that those who promulgate its agenda often have no idea that this is exactly what they are doing.
For all its remarkable attributes, Minnesota has recently gained national attention in a way we would prefer to avoid. Our state has the ignominious distinctions of both having the widest disparity in academic performance between White students and students of color and the highest health care disparity between White residents and people of color. How can a state with the nation’s top-ranked health care system, the Mayo Clinic, one of the nation’s best academic health centers at the University of Minnesota, and well-developed regional health care systems fail to deliver favorable medical outcomes to its communities of color?
I
It is a topic beyond the scope of a single article, especially considering that many in health care claim it could never happen in their profession. In this article we will shed more light on this important issue by addressing one of the most critical factors that affect patients of color: health plan exclusion of physicians in good standing without cause.
The reasons are varied. While experts can point to several demographic and economic factors, the most obvious is that Minnesota is in the minority of states that still permit health plans to deny health coverage for care by specific physicians. This includes even those willing to accept the health plan’s negotiated rates. The health insurers need not give a reason, and, in fact, they find it advantageous to provide no reason at all. Interestingly, if a health plan actually gave a reason for denying a patient their choice of doctor, the doctor may then have the right to appeal the reason provided. Quite simply, for the excluded physicians, “No reason given” means “no right to appeal.”
When cultural connections equal better outcomes For centuries, American health care has failed—often deliberately—to prioritize the health care needs of Blacks and other non-White people. Much medical care is universal and can serve different ethnic and racial communities. However, we are gaining a better understanding of how patients attain measurably better health outcomes when they have access to a physician with a shared ethnic, racial, or cultural background.
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Recent reports by National Public Radio (https://tinyurl.com/mp-npr), research by faculty at top institutions including the University of California at Berkeley and Stanford University (https://tinyurl.com/mp-uc-stanford), and a new report from the University of Minnesota, “Research Brief: Black newborns die less when cared for by Black doctors” (https://tinyurl.com/ mp-umn-newborns), are building on the body of information supporting the benefits of this access. These and many other similar reports conclude that Black patients who are treated by a Black physician achieve better outcomes. Specifically, Black patients were more likely to pursue more intrusive preventative medical care when recommended. Patients report better empathy from and comfort with doctors who share cultural, ethnic, and racial characteristics with the patient. There are reasons for the better outcomes from a shared background between patient and doctor. These include the greater shared cultural identity of physicians of color to work with other people of color who are traditionally underserved and often live in economically depressed areas. They also have
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empathy for and familiarity with the specific health care needs of ethnic patients and a higher comfort level among minority patients, including the view that minority physicians take them seriously and respect them.
No margin for error While Black Americans make up roughly 15% of the general population, Black doctors are only 4% of all physicians. With this significant shortfall in numbers of Black doctors to serve the Black patients, the exclusion of a Black physician from coverage by a health insurance plan has devastating effects on the health care structure and the care those patients receive.
alternative is not the best for the patient. By keeping a list of how each doctor stacks up in terms of cost, every doctor risks being dropped by a health plan if their costs are above the average, regardless of the population served by the physician. This unsavory deed is known in health insurance circles as “Economic Credentialing.” It is especially damaging to people of color, as many of their health care needs are higher cost based on health care disparities, including lack of earlier care and often poverty linked to poor health.
Black patients who are treated by a Black physician achieve better outcomes.
If the goal is to improve health care outcomes for people of color effectively, then health plans must not exclude a doctor in good standing from being fully covered under the health plan. Based on the number of Black physicians and Black patients in Minnesota, a health plan’s refusal to cover care provided by a physician of color can have up to four times the negative impact on the Black community than would the exclusion of other physicians whose race and ethnicities are well represented in the medical community.
In short, health plans make more money by restricting access. Fewer covered physicians means longer waiting periods to get an appointment and longer distances to travel. These factors result in less care provided to the insured, which means less care for the health plans to pay for. Again, this is especially challenging for those burdened by health care disparities, many of whom are employed hourly. That makes it a challenge to get to appointments, a factor often compounded by transportation issues. These obstacles add to the difficulty in finding a physician with a similar cultural or ethnic background. The unwanted intrusion of the insurance carrier into the patient-physician relationship is questionably unethical and certainly abominable.
For health plans, it’s about money Most patients are shocked, confused, and even scared when they first learn that their health plan won’t provide full coverage for care provided by a doctor of the patient’s choice. Why wouldn’t a health plan fully cover any licensed physician in good standing if the doctor is willing to accept the rates for service negotiated by the health plan? If Doctor A and Doctor B both accept the same payment for the same medical care, what’s the difference to the health plan? The answer is control. Suppose the health plan doesn’t have the power to exclude a doctor from its panel of physicians for whom they provide full coverage. In that case, they have no leverage over doctors through the threat of dropping them from their panel, nor can they limit the convenient access to care for patients by permitting them to see a physician in their community. After the Health Maintenance Organization Act of 1973 was passed nationally, Minnesota became the only state that did not allow for-profit HMOs. We were also one of the few states to allow health plans to exclude doctors from their member panels without cause. Only recently were laws changed to allow for-profit managed care, though they still may exclude doctors without cause. Do nonprofits only have the interests of the patients in mind? With executives who make millions or even tens of millions a year running “nonprofit” health plans, making money remains a premium. On top of that, when Minnesota recently eliminated the requirement for health plans to be non-profits, the state indefensibly retained the right to exclude physicians for no reason.
Addressing a systemic problem to page 164
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Many people ask how the right to exclude physicians gives health plans leverage or allows them to make more money. Leverage comes from forcing physicians to use low-cost treatments for patients, even if the cheap MINNESOTA PHYSICIAN AUGUST 2020
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3Addressing a systemic problem from page 15 lower economic strata. We now see that the same phenomenon has been How do health plans respond to these criticisms? One Minnesota playing out across Minnesota and the rest of the country for decades. health plan was challenged after refusing to admit a Black physician to its More pointedly, the White population—which is overly reflected covered physicians’ panel without providing a among health care leadership in the United basis. In response to an inquiry, the health plan, States—is not experiencing these same PreferredOne, claimed that it already had enough disparities. By contrast, the lack of access to physicians in that practice area and geographic minority physicians does not register on the area and didn’t need any more physicians in health plans’ radar of concerns. This lack of that specialty on its panel. (Although it was Health plans make more awareness or turning a blind eye to the immoral shown they did allow other physicians access to money by restricting access. difference in care based on race seen across their panel in the same geographic area shortly Minnesota is mostly to blame for the poor after). When questioned about how excluding health outcomes experienced by Minnesota’s the additional physician saves money and—as minority community. claimed by the health plan—keeps premiums low by blocking one of Minnesota’s limited number of Times do change Black physicians from its panel, the plan’s spokespeople refused to respond. Growing up in a medical household in Minnesota, I have seen an evolution in
Keeping the system of systemic racism systematized Perhaps the baseless exclusion of a Black physician from a physician panel is merely a cost-saving measure that does not consider Minnesota’s health care disparity between its White and minority populations. This type of willful ignorance resulted in “red-lining” of Black and other minority neighborhoods that has kept generations of people of color in Minnesota’s
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attitudes towards Black physicians in our state. My parents, both physicians, in the 1960s, were seen as Black people who were physicians. Over the past half-century, I have seen the attitude shift where I am seen as a physician, who happens to be Black. Subtle yet significant. My practice is composed of 65% White patients and 35% patients of color. Physicians of color enjoy seeing all patients and serve all patients well.
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However, in a state with a significant disparity in outcomes by race, it’s important to recognize that patients from underserved communities may feel more comfortable being seen by a physician with cultural similarities. For most patients, systemic circumstances minimize and typically eliminate any need for cultural connection with a physician. But for patients from communities that have not enjoyed those advantages, selecting a physician with a cultural connection or relationship will encourage access to better care and, according to the data, result in better patient outcomes and reduced health care disparities.
Now it’s time for a change The Minnesota Legislature can end the right of health plans to exclude qualified physicians in good standing at any time. This appropriate change would bring Minnesota into the majority of states with a “Patient’s Choice” provision that permits patients to see the physician they prefer with full coverage by their health plan at the health plan’s negotiated rates. States that have enacted this provision—also referred to as “Any Willing Provider” or “Any Authorized Provider” acts—require physicians to meet the instate insurance network’s requirements, but limitations may apply, and self-insured plans subject to federal regulation are not included. The Centers for Medicare and Medicaid Services allows patients to go to any doctor, health care provider, hospital, or facility that is enrolled in Medicare. Why shouldn’t patients be able to select a physician of their choice to care for themselves, their children, or their aging parents? This selection may be a physician familiar with the family or patient, or a physician with cultural similarities and understandings. Either way, this selection maximizes the chances for the best patient outcomes. It would also ensure that the limited number of physicians of color are available to Minnesota’s ethnically and culturally diverse communities. A “Patient’s Choice” law would bring improved health care outcomes for members of those communities. Passing a Patient’s Choice provision improves the likelihood of a more productive relationship between doctor and patient rather than one hindered by the threat of a health plan dropping the physician, potentially impacting the physician’s treatment recommendations. It also increases the pool of physicians available to all insureds, reducing the wait to secure an appointment and expanding the geographic access to patients with mobility challenges.
the doctor-patient relationship to focus on the needs of the patient without concern for the profitability of a health plan. Minnesota’s 20-year experiment with allowing exclusivity as an attempt at cost-saving has been unsuccessful and has contributed significantly to our state’s health care disparities. We must make that change. Charles E. Crutchfield III, MD, is clinical professor of dermatology at the University of Minnesota Medical School, immediate past president of the Minnesota Association of African-American Physicians, and medical director at Crutchfield Dermatology.
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Conclusion With all of its exceptional qualities, Minnesota must not accept having the nation’s worst disparity in health care outcomes between its White and nonWhite populations. By eliminating health plans’ right to exclude physicians from the health plan panels for full coverage, Minnesota can begin to improve access to physicians of the same ethnic and cultural background as their patients, leading to better outcomes. For patients of color, selecting a physician they connect with may be critical to improving their health care outcomes. This choice should not be taken from them, nor should it be withheld from anyone who wants to select a physician to care for themselves, their children, or their aging parents. Adopting a “Patient’s Choice” provision will help all Minnesotans by ensuring access and availability to their preferred doctor and by restoring
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PUBLIC HEALTH
COVID-19 in Greater Minnesota Addressing structural inequities BY CHARLIE MANDILE
T
he brutal murder of George Floyd at the hands of Minneapolis police reminds us of an ongoing reality: our society and culture does not value Black and Brown people. This tragedy is another violent symptom of underlying structural inequities and racism built into our power structures and society, and one that produces disparities in health. Our rural communities of Faribault and Northfield are not exempt. Rice County is home to approximately twice the state average of Latino immigrants, and to one of the largest communities of Somali refugees and their families outside of the Twin Cities. COVID-19 infection rates highlight the fact that Rice County is not immune from structural inequalities and racism.
Numbers from the pandemic Last month, Rice County Public Health reported that 36% of COVID-19 cases were diagnosed in individuals who identify as Black, and 33% of cases were in those who identify as Hispanic—rates far higher than the county’s percentages of 5.4% and 7.9% who identify as Black and Hispanic, respectively.
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As of June 12, 87% of Rice County’s COVID-19 cases resided in Faribault, even though Faribault makes up just 34% of the county’s population. Overall, Rice County is home to some of the highest rates of COVID19 in Minnesota, with the sixth-highest incidence rate in the state and the second highest in the Southeast region. The statistics are shocking but not surprising. These disparities are a product of embedded inequities and underlying socio-economic disparities. Over two-thirds of the students in the Faribault school district qualify for free and reduced lunch (provided for families within 125% of federal poverty guidelines), and the disparity ratio between Latino and White poverty is among the highest in the state. These socioeconomic disparities have put Latino and Somali families on the front lines of feeling the effects of this pandemic. While many Rice County residents have the privilege of working from home, many of our Black and Hispanic residents work in jobs that have been deemed “essential,” including local agricultural processing facilities and other fabrication and manufacturing line work. Latino and Somali groups are over-represented in professions that require working in close proximity, indoors, for extended periods. While many employers supported their employees to take precautions such as PPE, testing, awareness, and paid time off, other employers did none of the above. All worksites in these industries have been impacted by outbreaks among their workers. Despite the risks, these employees have been showing up to work— while putting their own health in danger—to support their community without question or hesitation. While many businesses were shut down by state order, our Black and Hispanic neighbors worked to ensure our society had what it needed when we were most vulnerable. Work such as food production, facility and custodial services, packaging, and fabrication happens in the background for many of us, but it is essential to our daily life and activities. However, the cost of this has been borne disproportionately by our Somali and Latino neighbors.
Longstanding barriers This pandemic has amplified existing challenges for everyone. We have all had to re-think our modes of transportation, where and how we get our food, and how to go about our lives at home to ensure our own safety. This crisis has magnified structural barriers for the underserved and traditionally marginalized. For example, we have all been inundated with messages of maintaining social distance at a time when public transportation and other public services have been limited or shut down. For essential workers in a rural area, there are even fewer options to get to work or the grocery store. As a result, our communities have developed robust networks of carpooling and ride-sharing. During the pandemic, nearly all workers share rides and airspace with not just a work team, but with a carpool group. “We wouldn’t hesitate to work with Engan Associates again.” (Matt Reinertson, Heartland Orthopedic Specialists)
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Informal networks of childcare, meal preparation, or grocery shopping are common sources of the strong community ties inherent to these cultures. While traditional structures and systems of societies have excluded
underserved communities from participating in these systems, communities drew on inherent strengths to provide for themselves. Unfortunately, new patterns of commerce—such as online grocery shopping, home delivery, cashless transactions, virtual meetings, socially distanced childcare, or transportation—are often unavailable to those with fewer resources. These communities have been traditionally excluded or marginalized from credit cards and the banking system, and disproportionately lack access to the internet.
educational materials, CHWs are an invaluable bridge brokering information between the clinic and the community. As trusted and embedded community members, they bring invaluable knowledge across the continuum of care, drawing on inherent capacities of communities to be healthy, and maximizing the impact of clinical interventions.
Pandemic amplifies health disparities
was one of the most pressing issues affecting the community during the pandemic. This led to the creation of a food distribution system, transitioning our waiting-room food pantry into an at-home delivery service that has distributed thousands of pounds of produce to patients who need it most.
For example, at the outset of the outbreak, our CHWs developed a “COVID-19 watchlist” of vulnerable patients who would benefit from proactive outreach and engagement. While our Rice County is home to During mandatory quarantine or stay-at-home EMR and clinical tracking systems similarly some of the highest rates of informed this list, it was the deep, personal orders, many of us fall back on the roof over our COVID-19 in Minnesota. community knowledge of our CHWs that helped heads as an ultimate source of refuge. Mortgage them identify dozens of patients who were perhaps forbearance or programs for landlords or tenants most vulnerable and who, in most cases, would not have kept many folks in their homes, just when have been captured by our clinical metrics alone. they needed it most. Somali and Latino families are During their calls, CHWs were able to provide underrepresented in these segments of the economy, invaluable support to patients, whether they had COVID-19 or not. This type often with month-to-month contracts, informal arrangements, or by renting of check-in kept patients healthy and connected just when they needed it most. rooms within houses. There are no programs for such renters, and when faced with economic difficulty, these groups are often left with nowhere to go. CHWs were also able to inform our wellness staff that access to food The housing picture becomes even more complex for individuals diagnosed with COVID-19. The number of our patients who have lost their housing— not because they couldn’t pay, but because their landlords wanted them out after a positive test result—is startling. While inconvenient, many people can imagine how they might distance or isolate a family member who has COVID-19, perhaps by having the infected individual use a separate bathroom or bedroom. But many underserved families live in multigenerational households, sharing sleeping quarters and facilities that all but ensure spread once a family member is diagnosed. Economic challenges are not new to health care, and existing barriers to care and insurance coverage continue to have an outsized impact during this time. It is common for facilities not to charge for COVID-19 testing. That being said, whether due to a mistake in the system or a built-in policy, it is not uncommon for patients to receive bills for testing. With economically vulnerable patients, one story or experience of being billed for a test can have a chilling effect on others seeking testing. Neighbors, family, or friends hear about the costs and become even more reticent to seek out a test.
Community-driven care Just as these structural and embedded challenges have been with us for some time, so have tangible solutions. For as long as these communities have been facing institutional barriers, they have been creating structures and institutions to take their place, particularly during the current pandemic, giving neighbors rides to test sites; bringing food to quarantined friends; caring for children; renting a room in a house; raising voices in solidarity, and donating food, supplies, or dollars. This is our community helping and healing itself. In the face of longstanding and persistent challenges, our community has resilience and power that is unwavering. At HealthFinders, our model of care is built around this concept. Health happens in community, and we have built an organization around this principle. Community health workers (CHWs) are a critical nexus, bringing a community context into clinical interactions, and clinical knowledge into community realities. Beyond culturally competent care or cross-cultural
COVID 19 in Greater Minnesota to page 234
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PUBLIC HEALTH
Education as health A partnership that is changing lives BY BRUCE CANTOR, MD, MS
A
high school diploma or GED (General Educational Development) certificate is required for many jobs, and can boost future earning potential—with incomes rising even higher for those who attend college. Individuals who have completed their education also experience lower rates of preventable conditions and better overall health. One Minnesota health plan is partnering with a national organization to pave the way on all of these fronts for its Medicaid and MinnesotaCare patients.
Covering education as a health benefit UCare, a nonprofit, community-based health plan serving nearly 300,000 Medicaid and MinnesotaCare members, now works with GEDWorks—the official turnkey education benefit program from the creators of the GED— under a pilot project to serve its members in 18 counties. The program helps members in select counties improve their employment prospects by paying for their GED-related training, support, and exams. It was an untested concept at the time of development, but the program has already helped participants jumpstart their careers, life aspirations, and
financial security—and may result in better health outcomes for them and their families.
Local disparities While Minnesota often ranks high in quality-of-life measures, it has some of the worst disparities in the nation when it comes to education and health. Only 82% of Minnesota students earn a high school diploma within four years; this number is significantly lower for students of color and for immigrant populations. Eighty-seven percent of the state’s White (non-Hispanic) students finish high school on time, followed by Asian students (84%), Hispanic students (65%), Black students (65%), and American Indian students (53%). When compared with other states, Minnesota ranks 34th out of 50 for overall high school graduation rates, according to data from the U.S. Department of Education. The rankings differ by demographics: the state ranks 32nd for White students, 45th for Native Americans, 46th for Asian Americans, 48th for Black students, and 50th for Hispanic students. High school incompletion perpetuates the cycle of poverty for these students. According to state data, having a high school diploma or GED increases earning power by 37.5%—a nearly $10,000 per year median wage increase. Education clearly has the power to help lift people out of poverty.
Education and health How does poor education affect health? According to the American Public Health Association, adults who do not complete high school have poorer health and are more likely to die prematurely from preventable conditions such as cardiovascular disease, diabetes, and lung disease. Other outcomes for those with different educational histories:
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Employment. Among Minnesotans 16 years and older, those with less than a high school diploma have unemployment rates of 13.1%. That rate is 3.1% for those with a bachelor’s degree. (Note: these figures predate the COVID-19 pandemic). Diabetes. Adults 18 years and older without high school diplomas or GEDs have diabetes rates of 11.1%, compared to 5.4% for those with college degrees. Prenatal care. Births without first-trimester prenatal care numbered 29% among mothers with a high school diploma or less. For those with more than 12 years of education, the rate was 13.6%. Smoking. Among those without a high school diploma or GED, smoking rates were 34.6%. Just 7.1% of college graduates smoke. The 2017 Minnesota Statewide Health Assessment stated: “Education is one of the clearest and strongest predictors of lifelong health. When we have more education, we are more likely to live longer, healthier lives. Success in school leads to higher earnings, and this improves our living conditions. Education allows us to find better-paying jobs, with healthier working conditions and benefits including health insurance and paid leave.” Children of educated parents are more likely to be healthy, too. Parents who are educated on the value of prevention are more likely to protect their
health and that of their children by scheduling recommended checkups, screenings, and immunizations.
The pilot program is capped at 200 members. Member impact will be evaluated for continuation or further expansion. UCare plans to expand the program to Minnesota communities where assessments show the greatest need and benefit to our members. We also will continue to expand member engagement in the 18 counties where the program is currently available.
Mental health can also benefit from education. In a recent blog post, Vicki Greene, president of the GED Testing Service, refers to a study that found young people who drop out of high school are more likely to be depressed than high school graduates in their early adult years. “Adults with higher levels of education often have better people skills, are afforded more advantages, and tend to Minnesota ranks 34th have better coping mechanisms—all of which lead out of 50 for overall high to better mental health,” she wrote.
Success stories
UCare’s first member graduate, Lydia from Blue Earth County, earned her credential in 2019 after years of wanting to do so but lacking the finances to pay for it. Lydia’s mental health issues in high school graduation rates. school caused her to leave before graduation. Health literacy Through GEDWorks, she was able to take practice The U.S. Department of Health and Human tests and work closely with a personal advisor. Services (HHS) defines health literacy as “the Within a month, she took the four GED tests and degree to which individuals have the capacity passed. Upon earning her GED, she applied and to obtain, process, and understand basic health was accepted to a local university, where she’ll start this fall. information needed to make appropriate health decisions.” It comes as no surprise that people with lower education levels struggle more to understand Irene from Montgomery, Minnesota, dropped out of school after health terms, prescription instructions, and treatment plans. In more than eighth grade to work. She had immigrated to Texas from Mexico at age 12, one national study, low health literacy was directly related to poorer health and later moved to Minnesota to join relatives and take a job with Seneca and lower educational status. Foods. For years the 45-year-old mother of four would attempt to study for her GED, but found it too hard to stick with it. When she received the Individuals with higher educational attainment also tend to use health care email from UCare inviting her to try the free program, she jumped at the resources more appropriately and efficiently—knowing when to see a primary care doctor, use telehealth, visit urgent care, or go to the emergency room. Finally, improved health literacy may empower people to be more proactive about their health and that of their families … and to embrace healthier lifestyles.
Education as health to page 224
A high school degree or GED is required for most jobs. Many of us take this level of education for granted, but, as discussed previously, the number of Minnesotans dropping out of high school is surprisingly high. Within UCare’s state public insurance programs, there are members who grew up with the odds stacked against them in impoverished circumstances—where education is difficult to pursue, life is about survival, or families struggle with mental health or substance use disorders. The UCare–GEDWorks partnership helps these members reverse the course of their lives with an extra level of support, advocacy, and encouragement, and to change the trajectory of their lives through education. The program equips graduates with the skills and knowledge they need to excel both inside and outside the classroom. Many of those who have obtained their GEDs through GEDworks have continued their education, with more than 50% attending college programs. These graduates also go on to pursue successful careers. Members are matched with a bilingual advisor, online study materials in English and Spanish based on assessment test results, connections to local adult education programs, practice tests, and free GED tests—all paid for by the health plan to provide a second chance at a high school diploma. Since UCare launched the program in a limited number of Minnesota counties in 2019, there have been nine graduates, with a tenth on track to take the test soon. More than 100 members are enrolled and studying. The program started in four rural counties and has since expanded to 18 counties across the state, including Dakota, Ramsey, and St. Louis counties.
Telephone Equipment Distribution (TED) Program
GEDWorks: advocacy and support
Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.
1-800-657-3663 ted.program@state.mn.us mn.gov/dhs/ted-program Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services MINNESOTA PHYSICIAN AUGUST 2020
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3Education as health from page 21 chance. Irene aced her practice test and passed her four tests in just two weeks. She appreciated the emotional support from her advisor at every step along the way. Irene will be applying for new positions at Seneca Foods for which she now qualifies. The best part—the pride her children have in her accomplishment.
Other participants offered similar praise for the health-plan sponsored program, which allowed them to pursue a GED without financial barriers, the support of advisors, the resulting career opportunities, and the simplicity of the program itself.
Building for success
We recommend that primary care doctors encourage patients to complete their GED at any For UCare member Christopher, earning his age. Some employers—for example, in the fastGED was a personal goal. He had wanted to do Adults who do not complete high food industry—sponsor free training, support, school have poorer health. so for many years, but the cost of preparation and tests for their employees. Community and testing were barriers. His previous education education programs often offer affordable GED was inconsistent, after changing schools several workshops and training. Patients who earn their times because of persistent bullying. Christopher GED will not only benefit from higher education successfully completed high school, but his school and career opportunities. They will be empowered lost track of his transcript, so he had no proof of to better understand and take charge of their graduation, which led to missed job opportunities. After studying hard and health and that of their families. completing all four GED tests, Christopher now feels a deep sense of pride and confidence. “It’s a major personal accomplishment which I celebrated with my family,” he said. Bruce Cantor, MD, MS, is a medical director at UCare, a nonprofit, Our most recent graduate, Vanida, sums up her surprise and appreciation for the program. She was aware that some companies offer GED support to their employees but said, “I think that it’s awesome to know you have some sort of medical assistance, and that they still support you in getting your GED.”
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community-based Minnesota health plan that offers Medicare, Medicaid, and individual and family coverage. Dr. Cantor earned his MD—and his master’s degree in Health Policy and Administration—from the University of Illinois at Urbana-Champaign. He is board-certified with the American Board of Internal Medicine and the American Board of Pediatrics.
3COVID 19 in Greater Minnesota from page 19 of which have torn families apart. Trauma is caused by the violent images, For patients seeking testing, CHWs were able to inform our outreach narratives, and realities replaying without end, incessant messages that and educate the community on what to expect, amplifying the impact of continue to devalue Black and Brown humans. our drive-through testing program. For patients We did not build these structural challenges, testing positive for COVID-19, CHWs were vital but we all have the responsibility to change members of an at-home monitoring program. and dismantle them. This may seem daunting, While clinicians kept close tabs on vitals and but everyone can start with themselves. Our symptoms, CHWs were navigating housing or community engagement team facilitates an employment challenges, family communications intercultural effectiveness seminar, unpacking Health happens in community. for hospital transfers, and much more. CHWs individual and institutional biases and assumptions worked in close contact with clinicians to in a cross-cultural lens. After training hundreds of coordinate all aspects of patient care. professionals across health, education, and social service sectors, we continue to see the impact of It’s everybody’s responsibility this work and the institutional change that begins It seems unimaginable how these tragic times are with individuals. layering on top of each other. Whether emerging outbreaks, or symptoms of dynamics in place for centuries, what is certain is that they share the same underlying causes: ingrained inequities, persistent disparities, and institutional racism. These populations in rural Faribault are poised to grow, with over 30% of the births to non-White families, and the school district recently becoming majority non-White. Rural institutions, including health care, have been slow to adapt to these changing demographics, exacerbating both inequities and the impetus for immediate change.
The time is now to break the cycle. Physicians and health systems share in the responsibility to identify new ways of collaboration to solve issues that cut across our entire society and culture. Ask yourself what you can do today to change how you practice to dismantle the root causes of racism that have produced such disparate outcomes in our patients for too long.
We see this pain manifest in communities that carry the weight of institutional violence and racism at the hands of law enforcement, both
Charlie Mandile is the Executive Director at HealthFinders Collaborative, a
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health care provider with offices in Northfield and Faribault.
WOMEN’S HEALTH
Menopause A multidisciplinary approach BY RACHEL S. CADY, MD, FACOG
W
omen over the age of 50 represent the nation’s fastest-growing population segment, according to recent Census Bureau data. This group—currently 64 million, or one-third of all American women— is expected to continue to rise rapidly as women live longer. The average woman lives one-third to one-half of her life in postmenopause, and 75% experience significant menopausal symptoms. Unfortunately, the small number of menopause specialists across the nation does not meet the demand, and Minnesota is no exception. The state’s menopause specialists are clustered mostly in metropolitan areas. Access to care for patients in rural areas presents both a challenge and a unique opportunity for new models of care.
One region’s story Throughout my years of OB-GYN practice in multi-specialty clinics in Crosby, Aitkin, and Mora, the change in demographics and needs of our patients has become more apparent. The population is aging in our area. Women desire a better quality of life but are bombarded with weak
SUNFLOWER SPREAD
guidance from questionable sources about their midlife/postmenopausal care. They are longing for avenues to address what is often an array of new and seemingly “strange” symptoms. They are busy women, a “sandwich generation” who do not want to travel far and wide for fragmented care. Cuyuna Regional Medical Center’s general OB-GYN department wondered if we could help fill the void in menopause medicine—and, if so, how to identify the “what, why, and how”? The “what” was the manageable part: the growing number of retirees to our Brainerd Lakes area. Many of my OB/GYN colleagues were not trained in menopause medicine or women’s sexual dysfunction treatment, nor in the unique needs of this aging population—but we wanted to learn. The “why” was that this is a dynamic area of medicine that is rapidly evolving. As a group, and as a hospital, we resolved to do better. The interest was there, along with the ever-growing need. The “how” was going to be through hospital support, careful planning, and continued learning. For a couple of years, we took stock of our local resources, did our prep work, and learned from others. To have a treatment center, we would need a team: dietitians with specialty training in menopause weight management, pain specialists, easy access to pharmacists for medication review, pelvic floor physical therapists, mental health providers with an interest and understanding of midlife, and many other components and involvement from primary care and other specialists. And above all, the mutual desire to do a good job, to fill a need, and to provide local care to patients. Throughout the course of attending live and virtual conferences from menopause and sexual medicine societies, hitting the books, networking with more seasoned practitioners in the arena, and becoming certified through the North American Menopause Society (NAMS), we were finally able to start our program.
Assessing needs The menopause transition (perimenopause) and menopause comprise a time of opportunity to make overall health assessments, plan for the future, and address the unique set of accompanying symptoms. This can be incredibly challenging for women to navigate on their own.
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The spectrum of concerns, questions, and bothersome symptoms associated with this natural phase of life varies dramatically. Bleeding concerns, low libido, painful sex, vulvar pain, hot flashes, weight gain, sleep disturbances, anxiety/mood changes, and hot flashes are just part of the vast array of common symptoms. Addressing health care maintenance guidelines, hormone replacement therapy (HRT), bone health, cancer risk assessment, and cardiac health is equally important for comprehensive care. All are paramount to healthy aging. Tragically, three out of four women who seek medical help for menopauserelated symptoms are left disappointed, confused, and misinformed. While Menopause to page 264
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3Menopause from page 24
Our group is comprised of OB-GYNs and nurse practitioners who are menopause practitioners certified through the North American Menopause Society (NAMS). With the help of a registered nurse and LPNs, team members work together to develop clinic procedures, patient education, and individualized treatment plans. We also serve patients at the Riverwood Health Care Center in Aitkin.
this statistic seems shocking, the root of the problem lies in the simple fact that many clinicians have not been properly trained in menopause care. The vast majority of physicians and residents report feeling at a loss when trying to address, counsel, and treat even the most basic symptoms associated with menopause. As a society, we have placed emphasis on contraception, prenatal care, and pap smears, but very little on perimenopause, menopause, and sexual Menopause care is a subspecialty concerns. Women are too often left to navigate their that requires a unique skillset. journey independently via web searches, headlines, and unregulated online supplements. For clinicians, menopause care is a subspecialty that requires a unique skillset and knowledge base. Comprehensive care for women experiencing menopause requires a collaborative group of specialists in multiple fields who are well trained in the unique nuances that are part of menopause.
A multidisciplinary approach Cuyuna Regional Medical Center’s Menopause and Healthy Aging program began in January 2019 to meet the needs of aging women as they transition through both perimenopause and menopause. The goal is healthy aging utilizing evidence-based medicine. The program provides personalized, interdisciplinary care for health issues specifically related to perimenopause, menopause, and sexual health.
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We work with certified pelvic floor physical therapists, pharmacists, dietitians, sex therapists, pain specialists, psychotherapists, primary care specialists, and other professionals who have expertise in midlife women’s health. The goal is to provide comprehensive, evidence-based consultative care and education under one roof in collaboration with the patient’s primary care clinician.
Our group offers multiple educational activities throughout the year for the community at large about issues specific to perimenopause and menopause. A website for patient education with current write-ups, videos, and blogs serves to inform both patients and the general public. An annual continuing medical education program on the most updated information in this field is offered to colleagues. Since the COVID-19 pandemic, monthly Facebook Live talks have been the primary modality for community education. Being a rural area, many of our patients prefer local access to care. Unfortunately, for Native Americans and other minorities, awareness about perimenopause and menopause, what to expect, and related health conditions is disproportionally lacking. Few studies exist about this topic, and there is little information about proven solutions. Optimizing telemedicine to reservation clinics, as well as education for clinicians, are two concrete measures to bridge the gap. The Cuyuna website features blog posts and videos to educate both the general population and clinicians. When a patient schedules a consult with our program, a member of the team calls the patient to preplan the visit, optimizing time and, ideally, minimizing unnecessary return trips to the clinic. Patients appreciate this extra effort, as it demonstrates both a respect for their time and a willingness to reduce onsite clinic visits during the COVID-19 pandemic. Patients are given options for phone, Zoom, or in-person consults. We utilize menopause-specific intake forms such as MENQOL (Menopausespecific Quality of Life), as well as problem-specific intake forms, particularly for individuals with libido/orgasm/vulvar pain-specific concerns.
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While consulting via phone visits, our team provides patients a recommended set of services, including labs work. Opportunities for streamlined services, if desired from the patient, also include imaging, vaccines, other specialty visits coordinated for patient convenience, “streamlined” care, improved compliance, and fewer unnecessary logistical frustration. During site visits, patients are made comfortable with warm blankets, iPads for education, and comfortable exam rooms. At the conclusion of the consult, each patient is given a Menopause and Healthy Aging packet with a care plan carefully outlined, along with evidence-based problem-specific information, a follow-up care plan, an explanation of personal expectations, and contact information for follow-up questions.
Additional resources The North American Menopause Society (NAMS) provides a standardized questionnaire for menopause patients that highlights many symptoms and conditions unique to menopause—sexual issues, mood problems, hot flashes, hormone replacement therapy, sleep concerns, and many more—to help focus individualized care in an efficient, effective manner. The organization offers online education videos for patients, a free app for clinicians called MenoPro for clinical guidelines, updated clinical publications, and patient handouts called “Menonotes.”
The International Society of the Study of Women’s Health (ISSWSH) is an equally valuable, multidisciplinary professional organization that carries out many essential purposes, including education and support for clinicians treating women’s sexual health. The International Menopause Society and National Vulvodynia Association are two additional resources for patients and clinicians.
The spectrum of concerns ... with this natural phase of life varies dramatically.
NAMS also provides a platform for clinicians interested in certifying in midlife care. Nationwide, there are approximately 1,100 NAMS-certified practitioners. NAMS is an excellent resource for ongoing educational opportunities and collaboration with other expert clinicians to receive help with challenging patient scenarios. The International Menopause Society offers additional training and medical education as well. For physicians who don’t want to become a certified practitioner but would like to screen women for menopausespecific health concerns and problems and determine insances that warrant referrals to a specialist, the NAMS health questionnaire can provide useful guidance.
The author acknowledges the contributions of the following menopause specialists and colleagues at the Menopause and Healthy Aging program: Michael Cady, MD, FACOG, NCMP; Melissa Goble, WHNP, NCMP; and Donna Claypool, WHNP. Rachel S. Cady, MD, FACOG, is the director of Cuyuna Regional Medical Center’s Menopause and
Healthy Aging program. She is a fellow of the American College of Obstetricians and Gynecologists and a certified menopause practitioner through the North American Menopause Society (NCMP). She is a member of the International Society for the Study of Women’s Sexual Health, the International Menopause Society, National Vulvodynia Association, AAGL, and AUGS.
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OPHTHALMOLOGY
Refractive surgery New options for patients BY JESSICA HECKMAN, OD
S
urgical correction of refractive error (myopia, hyperopia, astigmatism, and presbyopia) continues to evolve and advance. Expansions in both corneal and lens-based surgical technologies provide new refractive surgery options for more patients, including some who may not have been surgical candidates in the past. In addition, the technology for evaluating patients’ eyes for consideration of a refractive procedure has advanced to allow physicians more information to counsel patients on their candidacy for refractive surgery and to identify the most appropriate procedure.
The “SMILE” procedure Small incision lenticule extraction (SMILE) is the latest advancement in corneal refractive surgery. Since its approval by the FDA in September 2016, there have been more than two million SMILE procedures performed across the world. As with all laser-based corneal refractive procedures, SMILE reshapes the cornea to correct refractive error. SMILE is currently indicated for the correction of 1 to 10 diopters of myopia and 0.75 to 3.00 diopters of astigmatism.
The entire SMILE procedure takes 10–15 minutes, with about 30 seconds of laser treatment time. The patient’s eye is anesthetized with topical anesthetic, then a small 6mm incision is made on the superior cornea with the Zeiss VisuMax femtosecond laser. A contact lens-shaped lenticule is then made with the femtosecond laser in the stromal layer of the cornea 120 microns below the surface of the cornea. Subsequent removal of this lenticule changes the shape of the cornea to produce the desired myopic and astigmatic correction. The small incision, as well as tissue removal from deeper in the cornea, results in less impact on the corneal nerve plexus and a resultant lower risk of post-operative dry eye than with larger incision sizes. Patients often have the SMILE procedure done on both eyes the same day, as vision typically recovers to a functional level by the next day. These patients are on a post-operative course of antibiotic and steroid eye drops and are typically able to return to work the next day. The best candidates for SMILE are patients with refractive error within the FDA-approved range of myopia and astigmatism, have corneal shape determined appropriate for refractive surgery by the refractive surgeon, and have the appropriate corneal thickness. The procedure is contraindicated for patients under the age of 18 and for those with visually significant cataract, uncontrolled glaucoma or external disease, and hyperopic refractive error.
“Visian ICL”
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Surgical correction of refractive error is not limited to laser vision correction. The Visian ICL (Implantable Collamer Lens) has been FDA-approved since 2005. The indication for the lens is for vision correction of 3 to 15 diopters of myopia and less than 2.5 diopters of astigmatism, and reduction of 15 to 20 diopters of myopia. In September 2018, the Toric ICL was approved by the FDA, expanding the ability to treat patients with higher degrees of myopia and astigmatism. This lens is indicated for the correction and reduction of the same degree of myopia, as well as for patients with up to 4 diopters of astigmatism. As of April 2019, more than one million ICL procedures had been done globally. This procedure takes approximately 15 minutes in a sterile operating environment. A small incision is made in the cornea and the ICL is then implanted in the space behind the iris and in front of the lens (ciliary sulcus). The procedure can be done unilaterally or bilaterally. After the procedure, the patient is on a course of antibiotic and anti-inflammatory topical eye drops. Vision typically recovers within the first few days after the procedure. The ICL can be removed if necessary for any reason. The best candidates for this procedure are patients between 21–45 years old who have an anterior chamber depth (distance between the corneal endothelium and anterior lens surface) of 3.0mm or greater, and have a stable refractive history. The procedure is not recommended for patients under the age of 21 or for those who have a shallow anterior chamber or a low corneal endothelial cell density. Safety has not been established in patients with other active ocular disease that would, in general, limit a patient’s candidacy.
Replacement lenses
More information on a patient’s ocular system allows the physician to appropriately advise patients seeking refractive surgery on candidacy as well Intraocular lenses (IOLs) are implanted at the time of lens replacement surgery as the most appropriate procedure for patients who are candidates. Corneal (cataract or refractive). Presbyopic IOLs are available in various versions and topography has long been used to measure the shape of the cornea. Keratoconus designs, including accommodating, multifocal, and extended depth of focus. is a form of pathologic astigmatism where the cornea The benefit of these types of lenses for patients is progressively becomes steeper and thinner, resulting an expanded range of focus after lens replacement in loss of best corrected visual acuity and, in some surgery. This expanded range of focus allows the cases, the need for surgical intervention. The shape patient more freedom from glasses than traditional of the anterior surface and posterior surface of the monofocal (single point of focus) lenses. The most The ability to map and measure cornea, as well as the relative curvature between recent FDA approval of a presbyopic IOL was in the eye continues to become these surfaces, can be an indication of keratoconus, August 2019 for a trifocal IOL called PanOptix from more sophisticated. and corneal topographers are now able to very Alcon. The PanOptix lens has a ringed design to the precisely measure these relations. lens, providing patients with three zones of focus— distance, intermediate, and near—compared to previous multifocal designs with two zones of focus. The addition of the third focal point aims to provide patients with even less dependence on glasses than its predecessor lenses. Other trifocal and presbyopic IOL designs are currently in clinical trials. The best candidates for presbyopic IOLs are patients with corneal shape appropriate for refractive surgery and have generally good ocular health. Other ocular conditions that may limit the visual potential of a patient may limit candidacy for a presbyopic IOL.
Mapping the eye In addition to the advancements in surgical procedures for vision correction, the ability to map and measure the eye continues to become more sophisticated.
The visual clarity through the visual system can also be objectively evaluated. The I Trace from Tracey technologies uses optical ray tracing and topography to show a visual depiction of the visual blur in an ocular system from the cornea versus internal structures of the eye, including the lens, vitreous, and macula. This is often used to determine the presence of a dysfunctional lens or subtle cataract or if the ocular surface is causing significant blur due to irregular astigmatism, dryness, or other causes. HD Analyzer from Visiometrics uses an isolated light source from a laser beam that is reflected through the ocular medium twice. The size and Refractive surgery to page 304
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3Refractive surgery from page 29 This technology has the precision to separate the thickness of the epithelial layer of the cornea from the deeper layers of the cornea. This is an important advancement as the epithelial layer of the cornea thins over areas of ectasia. If the epithelium is thinned over an area of steepening on a topographic map of the cornea, it could be a sign of corneal ectasia. By contrast, an area of steepening which may be assumed to be pathology on a topographic map may be an artifact due to thickened epithelium. OCT technology is also able to take precise cross-section pictures of the retina and optic nerve to screen for any posterior segment pathology that may affect the vision potential or safety of a procedure for a patient.
shape of the reflected light source is analyzed and given a number on an ocular scatter index (OSI). A high OSI can be indicative of pathology within the optical system from media opacity, such as cataract, or significant dry eye or other pathology. Determining the clarity of the visual system often plays a role in the inclusion or exclusion of candidacy for certain refractive procedures. If significant lenticular opacity is present, the patient may be advised against corneal or ICL refractive surgery and an intraocular lens may be more appropriate. Significant ocular surface disease may need to be treated prior to consideration of any refractive surgery and may exclude a patient from candidacy for certain procedures.
Summary
“OCT”
Advancements in refractive surgery have allowed more patients access to surgical technology for vision correction, and the advancements in screening technology help physicians advise candidacy for surgical technology as well as the most appropriate procedure.
Optical coherence tomography (OCT) is used to detect and monitor many ocular diseases. OCT uses light waves to take cross-section pictures of the structures of the eye. The thickness of the cornea is important in the evaluation for candidacy for refractive surgery. Too thin of a residual corneal stromal thickness after corneal refractive surgery is a risk for the development of ectasia, or pathologic astigmatism. If a cornea is very thin, the patient may not be a candidate for corneal refractive surgery. These patients may be better candidates for a lens-based procedure or continued use of glasses or contact lenses.
Jessica Heckman, OD, is vice president of clinical affairs and optometric residency director at Chu Vision Institute in Bloomington. She specializes in the care of cornea, refractive, cataract, and glaucoma patients.
Corneal thickness has traditionally been measured with ultrasound to provide singular measurements of thickness of the cornea. OCT is now used to measure a more comprehensive thickness map of the entire cornea.
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Shana Zahrbock, Physician Recruitment Shana.Zahrbock@carrishealth.com (320) 231-6353 | carrishealth.com
• • • •
Orthopedic Surgery Psychiatry Psychology Pulmonary/ Critical Care • Rheumatology • Urology
Keeping the game fair... SHARE YOUR INSPIRATION.
On the U.S. Army health care team, you will enjoy the satisfaction of providing quality care to Soldiers and their families, in a setting with innovative technologies, robust resources and a dedicated, supportive team.
Learn more at healthcare.goarmy.com/nz72
©2018. Paid for by the United States Army. All rights reserved.
...so you’re not fair game. Your Minnesota medicine is getting hit from all angles. You need to stay focused and on point— confident in your coverage. Get help protecting your practice,
with a Mankato Clinic Career
with resources that make important decisions easier.
Established in 1916, physician-owned and led Mankato Clinic is 100 years strong and seeking Family Physicians for outpatient-only practices. Over 50% of our physicians are involved in leadership positions and make decisions for our group. Full-time is 32 patient contact hours and 4 hours of administrative time per week. Four-day work week available. Clinic hours are Monday-Friday, 8 a.m.-5 p.m. OB is optional. Call is telephone triage, 1:17, supported by a 24/7 Nurse Health Line. Market-competitive guaranteed starting salary, followed by RVU production pay plan. Benefits include 35 vacation / CME Days annually + six holidays, $6,600 annual CME business allowance and a generous profit-sharing 401(k) plan. We’re just over an hour south of the Mall of America and MSP International Airport. If you would like to learn more about building a Thriving practice, contact:
Healthcare Liability Insurance & Risk Resource Services
Dennis Davito Director of Provider Services 1230 East Main Street Mankato, MN 56001 507-389-8654 dennisd@mankatoclinic.com
ProAssurance Group is rated A+ (Superior) by A.M. Best.
Apply online at www.mankatoclinic.com
800.282.6242 • ProAssurance.com MINNESOTA PHYSICIAN AUGUST 2020
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3Biosimilars vs. biologics from page 13
conversion and the bigger savings. They trusted that the physicians in their network knew enough—or would learn enough—about biosimilars to confidently prescribe them instead of the reference biologic.
This drug class treats neutropenia, a condition that’s often a side effect from cancer. About 11,000 patients every year take a G-CSF drug, The other Blue Plans took a formulary-neutral position on the generally for about six months. But because it’s for patients with cancer, biosimilars. They relied on the physicians there are new patients with neutropenia who in their network to find the lowest cost drug need G-CSF, every month, every year. Since option to prescribe for the patients. But G-CSF biosimilars are priced 10–30% percent physicians don’t always have the time to search lower than the reference biologics, a small for the lowest cost drug or have easy access to Physicians don’t always change in prescribing habits could produce patient formulary and benefit information. have the time to search substantial savings. This information gap can contribute to a slower for the lowest cost drug. One case study by Prime Therapeutics in market shift to biosimilars. preferring biosimilars shows a big difference in When a biosimilar is a preferred formulary market adoption rates. Following a September drug, switching is seamless. But physicians 2018 recommendation from Prime, three can still choose a biosimilar, even if it’s not Prime Blue Plan clients changed their medical “preferred.” That’s the bottom line. If a physician policies to prefer biosimilars over the reference drug in the G-CSF class. knows there’s a biosimilar available to treat his/her patient’s condition, the Having several biosimilars in one drug class makes it easier to implement physician can prescribe it. That can make a huge difference in increasing the preferred-product benefit designs. Three Blue Plans who took an active use of biosimilars. management approach saw high conversion rates of 87%, 88%, and 98% in Breast or gastric cancer. Five biosimilars for trastuzumab (Herceptin) are 2019. Collectively, this delivered a cost savings of $4 million. By comparison, used to treat breast or gastric cancer. These are all approved and launched. If the formulary-neutral Blue Plans saw biosimilar conversions at about 24%. Prime’s Blue Plan clients prefer these biosimilars, we estimate that potential Why was there such a big difference in conversion rates? The three plan savings could total $31 million over two years. We’re working to do that Blue Plans that chose the active management approach aimed for the faster Biosimilars vs. biologics to page 344
Practice Opportunities throughout Greater Minnesota: Our nation faces an unprecedented number of individuals who having served their country now receive health care benefits through the VA system. We offer an opportunity for you to serve those who have served their country providing community based health care in modern facilities with access to world-leading research and research opportunities. We provide outstanding benefits with less stress and burnout than many large system policies create. We allow you to do what you do, best – care for patients.
Minneapolis VA Health Care System Metro based opportunities include: • Chief of General Internal Medicine • Chief of Cardiology • Cardiologist • Internal Medicine/Family Practice • Gastroenterologist • Psychiatrist
Ely VA Clinic
Hibbing VA Clinic
• Tele-ICU (Las Vegas, NV)
Current opportunities include:
Current opportunities include:
• Nephrologist
Internal Medicine/Family Practice
Internal Medicine/Family Practice
US citizenship or proper work authorization required. Candidates should be BE/BC. Must have a valid medical license anywhere in US. Background check required. EEO Employer.
Possible Education Loan Repayment • Competitive Salary • Excellent Benefits • Professional Liability Insurance with Tail Coverage
For more information on current opportunities, contact: Yolanda Young: Yolanda.Young2@va.gov • 612-467-4964 One Veterans Drive, Minneapolis, MN 55417
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AUGUST 2020 MINNESOTA PHYSICIAN
•
www.minneapolis.va.gov
A Place To Be Your Best.
YOU’D MAKE A REALLY GOOD DOCTOR IF YOU WEREN’T BEING AN OFFICE MANAGER.
Dr. Julie Benson, MN Academy Family Physician of the Year
POSITIONS AVAILABLE:
OB GYN & FAMILY MEDICINE – Full-scope practice available (ER, OB, C-Section, Hospitalist, Clinic) • Independent/growing system • Located in the heart of lakes country, Staples, MN • Critical access hospital with 5 primary clinics and a senior living facility • 15 family medicine physicians and 16 advanced practice clinicians • Competitive salary, benefits, and sign-on bonus available Contact Michael Paul at 218.894.8633, or michaelpaul@lakewoodhealthsystem.com
For more information, contact TSgt James Simpkins 402-292-1815 x102 james.simpkins.1@us.af.mil or visit airforce.com
©2013 Paid for by the U.S. Air Force. All rights reserved.
Family Medicine & Emergency Medicine Physicians • • • • •
Great Opportunities
Immediate Openings Casual weekend or evening shift coverage Set your own hours Competitive rates Paid Malpractice
Helping physicians communicate with physicians for over 30 years. MINNESOTA
AUGUST 2018
PHYSICIAN
THE INDEPENDENT MEDICAL BUSINESS JOURNAL
Volume XXXII, No. 05
CAR T-cell therapy Modifying cells to fight cancer BY VERONIKA BACHANOVA, MD, PHD
U
niversity of Minnesota Health is now among the few selected centers in the nation to offer two new immunotherapy drugs for the treatment of diffuse large B-cell lymphoma. Both drugs—Yescarta and Kymriah—are part of an emerging class of treatments, called CAR T-cell therapies, that harness the power of a patient’s own immune system to eliminate cancer cells.
Physician/employer direct contracting
CAR T-cell therapy involves drawing blood from patients and separating out the T cells. Using a disarmed virus, the patient’s own T cells are genetically engineered to produce chimeric antigen receptors, or CARs, that allow them to recognize and attach to a specific protein, or antigen, on tumor cells. This process takes place in a laboratory and takes about 14 days. After receiving the modification, the engineered CAR-T cells are infused into the patient, where they recognize and attack cancer cells. Kymriah received initial FDA approval in 2017 for the treatment of pediatric acute lymphoblastic leukemia. CAR T-cell therapy to page 144
Advertising in Minnesota Physician is, by far, the most cost-effective method of getting your message in front of the over 17,000 doctors licensed to practice in Minnesota. Among the many ways we can help your practice: •
Share new diagnostic and therapeutic advances
•
Develop and enhance referral networks Recruit a new physician associate
Exploring new potential BY MICK HANNAFIN
W
ith the continuing escalation of health care costs, large and midsized selfinsured employers are once again looking for an edge to manage their medical plan costs and their bottom line. They understand that they are ultimately funding health care as they pay for their population’s claims. Many of these employers have employed the same overarching set of strategies: shop for a new carrier that is willing to lower the administrative costs or underprice the risk, Physician/employer direct contracting to page 124
763-682-5906 | 763-684-0243 michelle@whitesellmedstaff.com www.whitesellmedstaff.com
•
Advertise! IN MINNESOTA PHYSICIAN www.mppub.com
PHYSICIAN
(612) 728-8600
MINNESOTA PHYSICIAN AUGUST 2020
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3Biosimilars vs. biologics from page 32
• The out-of-pocket cost to the consumer depends on whether the drug is covered under the pharmacy or medical benefit.
on the formulary level. And physicians can help increase uptake and savings opportunities by prescribing the biosimilars.
• Specialty tiers on a formulary may include a copay or a coinsurance amount.
Tips for prescribers The FDA provides a list of approved biosimilars at https://tinyurl.com/mp-fda-list, complete with name, approval date, reference product, and links for more information. The FDA’s Purple Book (https://purplebooksearch.fda. gov) offers lists of licensed biological products, identifying their related biosimilars. Search the FDA site for additional educational content geared to physicians, staff, and patients.
• Out-of-pocket maximums and/or high deductibles may apply. • Manufacturer’s financial assistance programs may be available.
For many drugs, it can take an average of 12 years from lab to medicine cabinet.
If a biologic is prescribed and indicated as “dispense as written,” no changes may be made. To receive a biosimilar, the physician must prescribe the biosimilar. Absent the “dispense as written” specification, under Minnesota law, a pharmacist may substitute a biosimilar, but only after informing the physician.
The cost to the patient? It depends. Consumers with health insurance are rarely paying the full retail price for a biologic or a biosimilar drug. Physicians often have to work with their patients and their insurance provider to understand specific cost-sharing situations. Factors will include:
Biosimilar savings have more of an impact on the health care system as a whole. Most of the savings accrue to the health plan and employer group. Over time, biosimilar prices continue to come down, which creates more pressure on the original reference drug price.
In conclusion As more biologics and biosimilars become available, improved care and opportunities for cost savings will expand. It is important for physicians to be aware of these issues. Jeremy Whalen, PharmD, BCOP, is Specialty Clinical Program Director of Oncology at Prime Enterprise Specialty Solutions.
Three patients. Who is at risk for diabetes?
When there are no signs or symptoms, you may not know until it’s too late. Act now. Screen your patients for type 2 diabetes. It’s easy. It’s covered. It will reduce their risk. • Refer your at-risk patients to a proven lifestyle change program and help cut their risk of developing type 2 diabetes in half.
1 in 3 adults are at risk!
• For patients who already have diabetes, send them to a quality diabetes self-management program to improve control and reduce complications. Find groups in Minnesota at www.health.mn.gov/diabetes/programs
Minnesota Department of Health DIABETES PROGRAM
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AUGUST 2020 MINNESOTA PHYSICIAN
URGENT RESOURCES FOR URGENT TIMES. In a pandemic, speed and access to information and resources are vital. Knowledge saves time, and you need all the time you can get to save lives. Introducing the COVID-19 Resource Center. Right here, right now, for you. On our website, you’ll find the latest information and resources for important topics like: • Telemedicine: including best practices and plain language consent forms • Links to infectious disease prevention guidance • Education and resources for healthcare providers on the front lines
You can access Coverys’ industry-leading Risk Management & Patient Safety services, videos, and staff training at coverys.com. All in one place, for our policyholders as well as for all healthcare providers. Thank you. For all that you are doing. You are our heroes, and we are here if you need us.
Medical Liability Insurance • Business Analytics • Risk Management • Education COPYRIGHTED. Insurance products issued by ProSelect® Insurance Company and Preferred Professional Insurance Company®
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Holly Boyer, MD
TRANSFORMING HEALTH & MEDICINE Leaders • Educators • Innovators
mphysicians.org