Minnesota Physician • May 2022

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MINNESOTA

MAY 2022

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXVI, No. 02

PHYSICIAN COVID-19 Litigation Cases and Defenses BY SANDRA M. CIANFLONE, J.D.

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t’s been more than two years since the world was besieged by the coronavirus pandemic that disrupted our lives in ways big and small as the novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) raced across continents. Global, national and local public health organizations and authorities scrambled to issue recommendations and advice based on the available science and knowledge at that time. And as soon as we incorporated that latest guidance into our daily routines, it became obsolete as scientists gained a deeper understanding of how coronavirus spread and the risks it posed to various subsets of the population. (Remember when we were supposed to quarantine our mail and Amazon packages for three days, and wipe down our groceries?)

Co-opetition An emerging trend in health care

COVID-19 Litigation to page 124

BY DAVID J. VOLLER, MBA, FACHE

C

o-opetition is a term that is emerging in business theory and is now gaining traction as an important part of health care. The principles and practices of co-opetition are credited to New York University and Yale business professors Adam M. Brandenburger and Barry J. Nalebuff. They introduced concepts in their book “Co-opetition,” first published in 1996. They posited a concept that involved the ideas of interfirm coopetition—the combination of cooperation and competition and how this affects collaborative innovation performance in competitive environments. The concept involved that the simultaneous cooperation and competition between Co-opetition to page 104


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55TH

Publishing December 2022

S ES SI O N

APRIL 2022

|

Volume XXXVI, Number 02

COVER FEATURES Co-opetition

COVID-19 Litigation

An emerging trend in health care

Cases and Defenses

By David J. Voller, MBA, FACHE

BY Sandra M. Cianflone, J.D.

DEPARTMENTS CAPSULES .................................................................................. 4 INTERVIEW .................................................................................. 8 Moving Medical Education Beyond the Classroom Meghan Walsh, MD MPH FACP

SENIOR CARE............................................................................. 14 Connected Communities By Mark Anderson, MBA, CEO

CARE COORDINATION

MINNESOTA HEALTH CARE ROUNDTABLE..................................... 16

Improving Communication and Outcomes

Aging well in greater Minnesota

Care Transitions Improving the safety net

BACKGROUND AND FOCUS:

PATIENT PERSPECTIVE.................................................................. 24 The Impact of COVID on People with Disabilities A need for proactive planning

As health care faces rising costs, chronic workforce shortages and seemingly ever increasing administrative burdens, the pace of evolution is unparalleled. One example is the emergence of care teams;

By Joan Wilshire, MPA

many different licensed and unlicensed providers working together to the top of their training. While this offers benefits it also creates new challenges. The two most critical are ensuring every provider is aware of the care a patient receives and the patient is aware of, and adheres to, his or her individual treatment plan. The complexities of these task have given rise to a new part of the care team, the care coordinator.

OBJECTIVES: Our panel will examine the role of the care coordinator, how and why it is becoming an increasingly important part of health care delivery. When care coordination may be provided by clinic or health system staff, by third party payers, by private industry contracting out-of state employees, and even by state health agencies, utilization of this tool can present conflicts, confusion and frustration. We will look at the different aspects of care coordination and provide insight into how www.MPPUB.COM PUBLISHER

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they work best in various practice settings. Mike Starnes, mstarnes@mppub.com

ART DIRECTOR______________________________________________________ Scotty Town, stown@mppub.com

JOIN THE DISCUSSION We invite you to participate in the conference development process.

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.

If you have questions you would like to pose to the panel or have topics you would like the panel discuss, we welcome your input. Please email: Comments@mppub.com and put “Roundtable Question” in the subject line.

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Mayo Announces $49 Million Rochester Laboratory Expansion The Mayo Clinic has recently announced that it is investing in a $49 million laboratory expansion project in Rochester. Construction for the project has started and will continue through 2025. The expansion will increase laboratory space at Mayo Clinic’s Superior Drive Support Center. The new space will house several clinical laboratories that reside in the Hilton Building, which is part of Mayo Clinic in downtown Rochester. Relocation of these laboratories to Superior Drive Support Center will allow them to expand and take advantage of more modern facilities. The expansion will include a new laboratory space for five clinical testing labs, new laboratory space for Mayo Clinic Biopharma Diagnostics and new laboratory support staff spaces at Superior Drive Support Center.

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The expansion project also will help achieve Mayo Clinic Laboratories’ strategy to provide diagnostics to Mayo Clinic patients across the U.S. and abroad. Patients will have access to laboratory testing through their health care team at Mayo Clinic, while health care teams around the world will have access to testing through Mayo Clinic Laboratories’ Test Catalog. In addition to the available tests, Mayo Clinic’s Department of Laboratory Medicine and Pathology is continuously innovating to introduce new tests as health care and diagnostics advance. “Laboratory diagnostics and interpretations are front and center when it comes to the patient journey,” says William Morice II, M.D., Ph.D., president of Mayo Clinic Laboratories. “The COVID-19 pandemic shined a light on the importance diagnostic testing plays within the overall health care system, and we are committed to expanding our testing to meet the needs of patients we serve at Mayo

MAY 2022 MINNESOTA PHYSICIAN

Clinic and through Mayo Clinic Laboratories.” Dr. Morice chairs Mayo Clinic’s Department of Laboratory Medicine and Pathology.

HealthPartners Reports Large Income Increase At their annual online meeting held the third week of April, HealthPartners reported record claims for health care services in 2021, as well as a $150 million increase in operating income. Unexpectedly high use of health care services lead to the increase, up by over 50% from 2020. Beyond COVID treatments, patients who had delayed seeking medical attention during the pandemic returned in record numbers for routine care and services. Andrea Walsh, HealthPartners chief executive, said “In 2021, we saw our highest-ever claims costs, paying more than $3.6 billion for members’ care. We saw more patients in the hospital who were sicker and needed to stay

in the hospital longer. We saw people who had held back from getting care and then came into our clinics and hospitals needing care for illness and injuries well beyond COVID.” In 2021, HealthPartners paid $7.6 billion in expenses from revenue of $7.75 billion, leaving operating income of more than $150 million — a 56% increase over operating income of $96 million in 2020. It was the second year of improved results following an operating loss in 2019. Last year’s operating profit margin was about 2%, meaning HealthPartners saw 2 cents of operating income for every dollar of revenue. “When we came into 2021, we had pent-up demand that came through the system, resulting in higher claims cost in 2021, but offset by higher volumes on the care side of the organization,” said CFO Penny Cermak. They also reported providing more than 900,000 system-wide telehealth visits during 2021, many related to behavioral health. Walsh


CAPSULES

cited that over the course of the last two years and moving into the third year of the pandemic, the demand for mental health and the need for mental health services continues to increase.

Minnesota’s Uninsured Rate at Historic Low New data released by the Minnesota Department of Health shows actions taken by state officials and the Biden administration helped drop the state’s uninsured rate in 2021 to 4.0%, the lowest level ever measured. “The Minnesota Heath Access Survey shows that more Minnesota families have been able to access and maintain their health insurance during this critical time,” said MNsure CEO Nate Clark. “Minnesota has been able to reduce the uninsured rate thanks in part to targeted, effective policies, including the expansion of premium tax credits that lower the cost of monthly premiums for private health plans available through MNsure.” The 2021 federal American Rescue Plan (ARP) relief package expanded access to subsidies to those who were ineligible previously and lowered costs for tens of thousands of Minnesotans who purchase health insurance through MNsure, the state’s health insurance marketplace. The cost savings drove a record number of sign-ups for MNsure as over 134,000 Minnesotans enrolled in 2022 health coverage – a 10% increase from last year. The enhanced benefits made available through the ARP are set to expire at the end of 2022 unless the U.S. Congress acts to extend them. “To keep Minnesota’s uninsured rate at this historic low and to help address the racial disparities in health coverage in our state, Congress must act to extend these cost-saving benefits,” said Clark. “Failure to act could increase out-of-pocket costs for thousands of Minnesotans and push some to drop their coverage entirely.” MNsure estimates that without congressional action to extend the benefits, about

70,000 Minnesotans who currently access premium tax credits through the marketplace will see higher out-ofpocket costs when the new plan year starts in January 2023. Over 10,500 individuals are estimated to lose access to all of their current financial help. Without an extension, MNsure estimates that net premium spending across the state may increase by 30% to 40%, or an average of $1,314 per year for those receiving premium tax credits. Some regions could see even bigger increases.

U of MN Researchers Develop Smart phone “labin-a-chip” A University of Minnesota research team has developed a new microfluidic chip for diagnosing diseases that can be powered wirelessly by a smart phone. The innovation opens the door for faster and more affordable at-home medical testing. Microfluidics involves the study and manipulation of liquids at a very small scale. One of the most popular applications in the field is developing “lab-on-a-chip” technology, or the ability to create devices that can diagnose diseases from a very small biological sample, blood or urine, for example. The research is published in Nature Communications, a peer-reviewed, open access scientific journal published by Nature Research. Scientists already have portable devices for diagnosing some conditions — rapid COVID-19 antigen tests, for one. However, a big roadblock to engineering more sophisticated diagnostic chips is the fact that they need so many moving parts. The University of Minnesota team was able to create a microfluidic device that functions without all of those bulky components. “It’s not an exaggeration that a state-of-the-art, microfluidic lab-on-achip system is very labor intensive to put together,” said Sang-Hyun Oh, an electrical and computer engineering professor and senior author of the study. “Our thought was, can we just

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CAPSULES

get rid of the cover material, wires and pumps altogether and make it simple?” The breakthrough involves the same technology used for contactless smart phone payment in stores. “This is a very exciting, new concept,” said Christopher Ertsgaard, lead author of the study. “During this pandemic, I think everyone has realized the importance of at-home, rapid point-of-care diagnostics. And there are technologies available, but we need faster and more sensitive techniques.” Oh’s lab is working with Minnesota startup company GRIP Molecular Technologies, which manufactures at-home diagnostic devices, to commercialize the microchip platform. The chip is designed to have broad applications for detecting viruses, pathogens, bacteria and other biomarkers in liquid samples. “To be commercially successful, in-home diagnostics must be low-cost and easy-to-use,” said Bruce Batten, founder and president of GRIP Molecular Technologies. “Low voltage

fluid movement, such as what Professor Oh’s team has achieved, enables us to meet both of those requirements.”

New Program Addresses PCS Shortage Crisis The Metropolitan Center for Independent Living (MCIL), in part through a $208,000 Community Innovation Grant from the Bush Foundation, has recently announced its plans to develop a first-ever credit-based curriculum leading to the credential of a Certified Personal Care Assistant. Facing an unprecedented national crisis in hiring and retaining direct care workers, also referred to as Personal Care Assistants (PCAs), the new program will give individuals access to a career offering professional growth opportunities, living wages, and immense personal rewards. There are nearly 140,000 people employed in the direct care workforce in Minnesota. Among those that require services from this

workforce are 612,000 Minnesotans with a serious disability. Our elderly population, another demographic that relies on PCAs, was 865,000 in 2018 and is projected to rise to 1,262,000 by 2030. The direct care workforce has the highest percentages of female and diverse workers of any workforce sector and will see increased demand for services in the coming years. The Certified Personal Care Assistant program addresses the workforce shortage while advancing economic equity through an industry-adopted credentialed career. “I do not know of a more severe crisis than what we are experiencing today in the home and community base services system with so many closings of group homes, nursing homes, severe worker shortages throughout our Long-Term Services and Supports system including Minnesota’s PCA Programs” said Jesse Bethke Gomez, MCIL Executive Director. As part of a three-year study that

involved many stakeholder groups, MCIL played a critical role in drafting the report “Recommendations to Expand, Diversify and Improve Minnesota’s Direct Care and Support Workforce.” In response to the report and in recognition of the workforce crisis, in 2021 our state legislature passed into law the Minnesota PCA Rate Framework, which considers competitive workforce factors such as compensation. The new law, together with the Certified Personal Care Assistant program, will help solve problems that have daunted the PCA workforce and lead to higher, livable wages.

Fulcrum Health, Inc. announces 2022 ChiroCare Centers of Excellence Fulcrum Health, Inc., a nonprofit physical medicine management organization committed to leveraging chiropractic care to transform healthcare, recently announced the 2022 list of

Opening January 2023

Clinic space and practice opportunities available Matt Brandt | 715-531-6862 mbrandt@hudsonphysicians.com

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HudsonMedicalCenter

MAY 2022 MINNESOTA PHYSICIAN

Hudson


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ChiroCare Centers of Excellence. The designation recognizes the ability to meet evidence-based guidelines and stringent quality standards designed to put patients at the center of the treatment experience. The ChiroCare Centers of Excellence designation grew out of Fulcrum Health’s 2013 National Task Force on Spine Care, which identified the key qualities of clinics that exemplify a value-based, patient-centered approach to advancing the treatment of low back pain. This year’s additions bring the number of ChiroCare Centers of Excellence to a total of 193 providers at 102 locations across Minnesota, Wisconsin and South Dakota. “Providing health care needs and meeting patient expectations has changed dramatically in recent years, and the patient experience has become more complex. Providers who put patients at the center of the care experience can improve clinical outcomes while helping patients feel supported and engaged in the process,” said Dr. ViviAnn Fischer, Chief Clinical Officer, Fulcrum Health. “Our ChiroCare network consists of more than 2,900 providers who deliver outstanding care to over 2 million patients. The Centers of Excellence designation celebrates those clinics that go above and beyond to put patient-centered standards of quality at the core of their operations.” Fulcrum Health identifies ChiroCare Centers of Excellence through an application and document review process. To earn recognition, clinics must meet criteria related to shared decision-making between provider and patient to create goals of care, motivational interviewing and biopsychosocial assessment, documentation of measurable goals and conservative use of radiology. Also considered are exercise instruction to empower patient self-care, home care and prevention education and patient care coordination Fulcrum Health recognized the first ChiroCare Centers of Excellence in 2016”

Cuyuna Regional Hospice Program Named Honors Recipient Cuyuna Regional Medical Center was recognized earlier this month for providing the highest level of quality, as measured from the caregiver’s point of view, by being named a 2022 Hospice Honors recipient. The award was bestowed by HEALTHCAREfirst, a leading provider of billing and coding services and utilized Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey data. “Hospice Honors recipients are industry leaders in providing quality care and constantly seeking ways to improve,” said Ronda Howard, Vice President Revenue Cycle at HEALTHCAREfirst. “We are honored to be aligned with such high performing agencies like CRMC and we congratulate them on their success.” Award recipients were identified by evaluating performance on a set of 24 quality indicator measures. Performance scores were aggregated from all competed surveys and were compared on a question-by-question basis to a National Performance Score calculated from all hospices contained in the HEALTHCAREfirst’s Hospice database. CRMC’s Director of Home Care/Hospice Jennifer Wiedell credits the entire team’s efforts to provide exceptional, respectful, personalized care for being named a 2022 Hospice Honors recipient. “This award shines a light on the hard work of our entire team including physicians, nurses, aides, social workers, therapists, the chaplain, massage therapist, administrative team and volunteers,” Wiedell said. “All patients and families deserve high-quality medical care at the end of life, which is why we remain focused on supporting them in living each day to the fullest. Our team takes pride in providing the best possible patient experience, and we are honored to receive this award.”

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INTERVIEW

Moving Medical Education Beyond the Classroom Meghan Walsh, MD MPH FACP

Besides your work as a hospitalist, you

therapy trials, COVID-19 PCR testing with rapid result turnaround, life support and intensive care for the sickest of our patients. As one of the first labs to build testing protocols, we quickly became the testing resource for the state and other health systems in town. But our mission led us to the focus on the disparities arising from this pandemic. We brought testing to skilled nursing facilities and jails to quickly test and isolate affected patients in these high risk settings. When we deploy research alongside great clinical care and train others to these evolving systems, we quickly iterate our care to meet any clinical challenge; navigating the COVID-19 pandemic was no exception.

are the chief academic officer at Hennepin Healthcare. Please tell us about what that work entails.

As a teaching hospital, how has the importance of what HCMC provides increased with the changing ways physicians

Our “...”community partnerships are critical to our mission.

“...”

Hennepin Healthcare is a teaching hospital and clinic system. We have over 300 residents and fellows physicians who train in over 30 specialties here. We also have nearly 100 medical students who come to Hennepin for their clinical training. Once you are a practicing physician, you are also expected to continue to advance your knowledge in your specialty. My job is to ensure this clinical learning environment is the best it can be for all of these learners, from a college student interested in medicine to a first year medical student to a seasoned faculty physician who has been in practice for 40 years. I also play a role in strategy for the organization—ensuring we are a dynamic learning organization now and well into the future. I have the best job!

expertise and advance our collective knowledge and practice.

More recently, we have nurtured greater partnerships with our community and plan to attend Open Street Festivals to co-create solutions to the health care challenges facing Minnesotans. The future of research is ending the disparities that exist in health care today. While HCMC is perceived as a safety net hospital, there are several other hospitals with a much higher percentage of Medicare

are fulfilling CME requirements?

The Hennepin Healthcare Research Institute

reimbursement. What are some of the

Medical education has been a key part of our mission for over 100 years. So much has changed and evolved in how we teach and how we learn during this time. Advancing technology, competency-based medical education change and the practice of medicine in this complex environment has led to new knowledge gaps and needs and opened the door to novel ways to close those gaps. We have moved beyond the classroom and traditional teaching methodology. Technology has allowed us to create more engaging coursework that is more flexible and comprehensive. This was critical during the peak of COVID -19, as it allowed us to continue to safely teach and learn in new ways. We have also developed incredible simulation-based training that allows us to hone our skills in high acute settings, improve teamwork training and continuously improve our competency with rare but essential procedural skills. Our future will require more partnerships with communities in Greater Minnesota to share

(HHRI) has been active since 1951

misconceptions about your patient mix?

improving health care and is recognized

I don’t think people understand the truly unique role Hennepin Healthcare holds in the Minnesota health care landscape. While there are other hospitals that take care of more patients covered by Medicare, HCMC stands alone in the percentage of revenue that comes through Medicaid (health care paid by a state and federal partnership for people who meet certain requirements around income, disability and family status). In data provided to us by the Minnesota Department of Human Services, adult patients covered by Medicaid getting primary care from our system have significantly higher rates of chronic conditions than other Minnesota adults on Medicaid. In that same data set, we see our adult patients have experienced homelessness at more than double the rate of other Medicaidcovered adults. Lastly, the majority of our patients identify as BIPOC, reflecting the dynamic diversity of the communities we serve.

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as a national leader. What are some of the projects they are working on now?

HHRI plays a critical research role in Minnesota. Many are surprised that we consistently rank in the top 10% nationally of institutions receiving National Institutes of Health (NIH) grant funding. Our four focus areas of research align with our expertise as a health care safety net: addiction medicine, trauma, infectious disease and health services research. Our unique role as teachers, researchers and clinicians, as well as our commitment to equity and inclusion, placed us at the leading edge of research and care during the pandemic. If you were a patient coming to Hennepin in the early stages of the pandemic, you had the opportunity to participate in Remdesivir trials (COVID antiviral therapy,) convalescent plasma immune


What are some of the other things people

In every session, the State Legislature

may not understand about HCMC?

considers bills that impact how healthcare

Most people know that we are an adult and pediatrics Level 1 Trauma Center, but we are way more than that. We have a downtown hospital and eight primary care and specialty clinics throughout the metro area. We have a cuttingedge Hyperbaric Chamber which supports the region; last year we had over 5,500 treatments. We also have an integrated emergency care set of services, including our Emergency Department which had over 93,000 visits last year and 87,000 ambulance runs. The Midwest Poison Control Center resides here. Our mental health care is some of the best in the state and includes inpatient care, outpatient care and the Redleaf mother baby center. Our community connection care ring includes hospice care and Minnesota Visiting Nurses Association home care, as well as the jail and healthcare for the homeless services. When our state faces an emergent health risk, we are there. We have experts in Emergency Preparedness who have led us through the I-35W bridge collapse and the COVID-19 pandemic.

is delivered. What are some of potential improvements you would like to see enacted?

The flexibilities in health care regulations during the public health emergency (PHE) provided a time to test some innovations in health care we otherwise would not have been able to trial, and we made some incredible strides forward because of them. During the PHE, patients on Medicaid were able to stay enrolled without additional paperwork for a full year, instead of jumping through the hoops of reenrollment multiple times per year as we did pre-PHE. Previously, many people would churn off and on the program throughout the year, causing significant costs to the state, insurance companies and providers, as well as major disruptions to patient care when people suddenly found themselves without insurance coverage because they had moved and missed a letter, or missed a deadline or their income varied one month to the next. Throughout the PHE, the federal government allowed continuous eligibility for anyone on

Medicaid, verifying eligibility only once per year. Verifying eligibility one time per year was be a game changer for consistency in care and lowering costs to our system for unnecessary bureaucratic and administrative burdens. Allowing easier access to telehealth during the PHE has changed how we provide care, as we were opening up clinical connections frequently missed before. These flexibilities in telehealth must continue for patient access–we could take their lunch hour to meet with a doctor instead of taking a half day of vacation, they could forego a three hour drive from Greater Minnesota and instead spend 30 minutes on video with a specialist. The access to video for appointments was apparent, but we must not let access to audio be considered a second rate service. Video is ideal, but in those situations where it is not possible, we need to ensure audio continues to be reimbursed at a rate that incentivizes the option to keep it available to patients.

Moving Medical Education Beyond the Classroom to page 284

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3Co-opetition from cover businesses yield several benefits. This concept considered many elements, the main one being that every competitor and customer gained from a shared relationship between organizations that may have been perceived, or themselves perceived, as competitors. The simultaneous cooperation and competition between businesses could yield several benefits. The main benefit is that every competitor and customer sees an exponential gain from the relationship.

Applications in health care Applying this business theory in the health care industry might brings added levels of nuance and complexity. As the term co-opetition probably does not resonate in the vocabularies of most health care leaders, when given industry specific context, we might find the concept is not as foreign as it may seem. Two years ago, working as a consultant, this term first entered my vocabulary when it was mentioned by a colleague as we were assisting clients. Fraught with the challenge many health care organizations face of losing independence and finding themselves at the table of a merger/acquisition, or even worse, closing their doors, many organizations facing these dilemmas are looking for ways to avoid them and actually thrive. Becker’s Hospital CFO Reports, published in December 2021, identified 73 closures of rural hospitals over the past 10 years with a bit of an increasing trend. About 60 million people—nearly 1 in 5 Americans — live in rural areas and depend on their local hospitals for care. The number of rural hospital closures steadily increased over a four-year period, with a record-breaking

20 hospitals shutting down last year. In a rural setting, there may be less opportunity for co-opetition; however, many of the hospitals that shut down over the past decade still provide some health care services, such as urgent care, primary care or long-term care. In about the same period as the Becker findings, Deloitte published a report showing an annual average of 84 heath organizations had some sort of merger or acquisition. While such pairing of organizations is highly driven by building better economies of scale, aspects of ensuring high quality and better outcomes are still critical. The article further identifies through a survey done with health care executives who had been part of a merger and acquisition that 80% saw significant capital investments and another 70% achieved some of their transactions projected for cost structure efficiencies. While this reflects positively for mergers and acquisitions, organizations developing a more co-opative structure can see the same. With the importance of managing costs, operating with less margin and new threats of consumerism entering the industry, much of this is not surprising. We have to recognize that health care is a consumer-driven industry. Patients are realizing a lot more of the cost out of their pocket, and they are playing a much bigger role in where and how they get care. So what do we do to survive, especially as we see new entrants in the market like Walmart, Best Buy and Amazon, who are very nontraditional providers, as well as increased competition with greater systemization through mergers and acquisitions and even more care offered virtually? There may be an answer in co-opetition.

Practical examples Someone recently said that co-opetition has a bit of a spongy definition, but it is really quite simple. It is nothing more than collaborating with those likely seen as competition to achieve gains that are exponentially greater for both parties and consumers than that of working independently. To some degree, we already do this with various arrangements in health care, like outreach programs, third party arrangements for knowledge and resource sharing; even referrals can reflect a form of co-opetition.

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Fast forward my career a bit. I left health care consulting and returned to the direct patient care setting where I found myself in the throes of this very model of co-opetition. Two years ago, our organization sold a 118,000-square-foot hospital which provided every bit of inpatient, outpatient and surgical care. Our average daily census had been steadily declining. In our case, as a pediatric orthopedic center of excellence, we were finding many of our procedures could be accomplished in an ambulatory space without hospitalization. We now lease an 18,000-square-foot medical office as an ambulatory care clinic. The interesting thing is we still provide inpatient/outpatient surgeries and have patients admitted for inpatient stays when necessary. To do this, we collaborated with a direct competitor and lease time from them to do surgeries and admit patients when necessary. What are the wins in a relationship for both parties? We no longer have to cover the overhead costs of unused space and staff resources to be operational. Our competitor gains an increase in utilization of their ORs and additional inpatient stays for the kind of patient they know how to manage. For the patient, the gain is they get the best care.


• Team up against larger competitors. Smaller companies, This sort of win also happens in the reverse for us. Previous competitors especially technology startups, may be in competition with each are asking us to operate and staff programs which they struggled to keep other and a larger, well-established company. Cooperating can running but want to keep as a viable offering to their patient populations. allow the smaller companies to rival the larger one. While it helps that we are a subspecialized provider for pediatric orthopedics, the variations for these kind of relationships are considerable. • Improve market performance. Competitors can work together A good example is that independent radiology to penetrate new markets or develop programs are now in place in many competing existing ones. Developing existing markets organizations. Similarly, medical specialty means providing a better product or service practices may become the complimentary to the current customer of a company. partner supporting health care organizations Market penetration means tapping into who curate or create the assembly of care services There are several benefits new markets through collaboration with for populations of patients. to co-opetition. competitors in target markets. Such co-opetition is really not that new, and while it may feel that way to the health care industry, the world has a history of such efforts. The moon landing just over 50 years ago is remembered as the culmination of a fierce competition between the United States and the USSR. But in fact, space exploration almost started with cooperation. President Kennedy proposed a joint mission to the moon when he met with Khrushchev in 1961 and again when he addressed the United Nations in 1963. It never came to pass, but in 1975 the Cold War rivals began working together on Apollo-Soyuz, and by 1998 the jointly managed International Space Station had ushered in an era of collaboration. Today a number of countries are trying to achieve a presence on the moon, and again there are calls for them to team up. Even the hypercompetitive Jeff Bezos and Elon Musk once met to discuss combining their Blue Origin and SpaceX ventures.

• Foster technological innovation. Competitors working together drive innovation. Each company involved in the relationship can add what they learn from the collaboration to their own products or services. • Establish industry standards. Competitors in the same industry can share data and drive adoption of a given technology. Doing this can assist in developing standards and requirements that help the industry without jeopardizing a company’s intellectual property or core competency. Co-opetition to page 294

Making it work The expanded adoption of co-opetition in health care will combine existing approaches from other industries with the unique dynamics of providing patient care. To reach co-opetition’s best potential, it will be important to develop careful strategies and ask difficult internal questions. How can we reposition what may have been a competitive and possibly adversarial relationship with a nearby health care entity to one of shared goals for mutual gain? Can we create a focus on the centrality of multiple stakeholders in forming, executing, and developing co-opetition? The parties will have to agree on how far to extend their cooperation, who is in charge, and how to terminate the arrangement should it no longer make sense. They will need to agree to acknowledge that the benefits of shared knowledge and resources outweigh continued investment in dysfunctional competition. There is an emotional aspect to this approach, and some people will embrace the idea of no winners or multiple winners while others will be steadfastly against it. Fostering co-opetition can allow organizations to do the following: • Share strengths. Companies can combine their unique advantages and complementary strengths so that each can benefit while remaining in competition with each other. This allows them to create a more complete product together. • Distribute the workload. Coopetitors can grow their business network and merge their workforces to take on projects that are too big for one company. MINNESOTA PHYSICIAN MAY 2022

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3COVID-19 Litigation from cover

The claims against the aging services community are mostly based upon the facility’s infection control protocols and staffing procedures at the time. These claims are typically wrongful death claims due to a loved one contracting COVID-19 while they were a resident at the facility or personal injury claims as a result of a health care provider’s limitation of the types of procedures being performed.

As the pandemic raged on, these organizations and authorities emphasized an unprecedented need for health care providers and facilities to make difficult decisions such as care prioritization, staffing changes and purposeful allocation of personal protective equipment and diagnostic tests. Doctors, nurses and other health care providers had to wear the same N95 protective face mask for numerous patient visits across numerous shifts, which would More than 15,000 lawsuits have have been unheard of before the pandemic. Assisted been filed related to COVID-19. living and aging care facilities limited or halted visits from family members, and patients had to enter hospitals alone to limit exposure and spread of the virus. It is in the context of these fast-changing situations and decisions made under unprecedented strain on our health care system that COVID-19 litigation lays. By some estimates, more than 15,000 lawsuits have been filed related to COVID-19, with approximately 360 filings directed toward the health and medicine communities.

Aging services claims The majority of the claims we are seeing so far are primarily filed against the aging services community, although there is certainly no shortage of claims against hospitals, individual medical providers, airlines, cruise lines and insurance companies.

We are also seeing claims against facilities for allowing health care providers to provide direct patient care versus telemedicine, and we’ve seen claims for the opposite scenario when the facility chose to provide care via telemedicine. These claims are typically plead in the general sense to avoid the litany of state and federal immunities and defenses available to these communities.

Claims related to COVID-19 treatment

The next largest subset of claims are those against hospitals and health care providers for delivering care and treatment directly to COVID-19 patients. These claims arise out complications that occurred as a result of the specific treatment rendered, such as intubation or off-label use of other vaccines and therapeutics. Recently, we have also seen claims arising from delays in treatment due to public health organization recommendations regarding the prioritization of medical procedures. For example, rescheduling laparoscopic meniscal tear repairs with further development of the tear. The other type of claims we are seeing filed at this juncture are within the employment context. These claims are premised on wrongful termination/reduction in force, failure to notify of COBRA benefits, workers’ compensation and other employment-related matters. Another factor is the statute of limitations may be approaching on many of these claims, depending upon the state in which they are filed.

The next wave Following the direct treatment claims, we have seen significant litigation involving vaccinations and vaccination mandates. Vaccination lawsuits focused on factors such as: • How and when the vaccine was administered. • Availability of the vaccine (or lack thereof). • Scheduling of second doses and boosters. • Conditions of the vaccination site, i.e., whether people had to wait outside in the heat in long lines.

Defenses for COVID-19 lawsuits Virtually every organization and individual in the health care industry is compelled to defend against coronavirus lawsuits, and there are some important defenses available for these claims. Here is an overview of the most common defenses that we have used over the last two years.

The Public Readiness and Emergency Preparedness Act (PREP Act) By way of background, the PREP Act (Act) was first enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (“PHS”) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

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Originally, the Act was intended to protect vaccine manufacturers from financial risk in the event of a federally declared public health emergency. As such, the Act was specifically designed to encourage the rapid production of vaccines to protect American citizens in the case of a potential public health threat. COVID19 was not the first time that the Act was invoked. Declarations under the Act were issued during the avian flu outbreak, H1N1 pandemic and Ebola virus. The Act’s protections in these instances were focused on their respective vaccines. The Act provides broad immunity from suit and liability to any “covered person” with respect to all “claims for loss arising out of, relating to, or resulting from” the “administration” or “use” of a “covered countermeasure” if a declaration has been issued with respect to that countermeasure. The Act states: [A] covered person shall be immune from suit and liability under Federal and State law with respect to claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. “Loss” is broadly defined as “any type of loss,” including death, physical injury, mental injury, emotional injury, fear, property loss and damage and business interruption loss. Moreover, the immunity applies to any claim “that has a causal relationship with the administration or use by an individual of a covered countermeasure.” The powers and protections of the Act lie dormant in the United States Code until the Secretary for Health and Human Services (HHS) issues a declaration identifying the scope and applicability of the Act in response

to a unique public health emergency. In this case, on March 10, 2020, the Secretary of HHS issued the implementing Declaration invoking PREP Act immunity for “recommended activities” undertaken in response to the COVID-19 pandemic from February 4, 2020 through October 1, 2024. Since its initial publication, the declaration has been amended seven times, both expanding the scope of immunity and clarifying and emphasizing that the Act is a complete preemption statute. The far-reaching coverage and implications of the COVID-19 Act’s declaration and amendments are enormous enough to write volumes of legal literature and dozens of law review articles. For the purposes of brevity in this article, a short discussion of the terms and elements of PREP immunity are sufficient.

Covered Persons “Covered Persons” under the Act include manufacturers, distributors, program planners, and qualified persons, as well as their official agents and employees who prescribe or use covered countermeasures. The declaration specifically states that the immunity conveyed specifically applies to manufacturers, distributors, program planners and qualified persons. Of the more ambiguous “Covered Persons” listed above, “program planners” include those who supervise or administer a program dealing with covered countermeasures and includes those people who establish requirements, provide policy guidance or supply technical or scientific advice or assistance to provide a facility to administer or use a covered countermeasure. COVID-19 Litigation to page 264

Transforming Healthcare

St. John’s Hospital, Linear Accelerator, St. Paul, MN

eapc.net

MINNESOTA PHYSICIAN MAY 2022

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SENIOR CARE

Connected Communities Aging well in greater Minnesota BY MARK ANDERSON, MBA, CEO

M

innesota is now home to one million older adults, approximately 20% of our state’s population. By 2030, one quarter of Minnesotans will be over 65. As CEO of Knute Nelson, a senior services provider based in Alexandria, I see these demographics directly affecting my rural community. A common fear of older adults is becoming a burden to others and gradually losing their independence. One bad fall or an episode of congestive heart failure can cause seniors and their family to panic about their safety. In my experience, most people wish to be as healthy and self-sufficient as possible. The reality is that 70% of us will need help with daily tasks as the years pass. We may start to have problems with balance or become unable to drive. Our eyesight may get fuzzy. Taking care of our home chores might get harder. The signs of aging may seem a long way off in your life, if you have not personally struggled with a chronic condition or seen a loved one lose self-sufficiency. Yet, it could happen tomorrow to someone in your family or one of your long time patients.

Most communities have options for aging services and supports; however, most people don’t know about them until a crisis hits. It can be hard to ask for help or even to know where to look. That is why last year, working with our local health care providers and other community partners, Knute Nelson launched a pilot project called Connected Communities for Healthy Aging (Connected Communities). It is funded by a $900,000 pilot grant through LeadingAge MN Foundation. The UCare Foundation contributed $100,000 to the innovative pilot. Our goal is to provide a more integrated system of caring for seniors and to help them live their best lives.

A new approach to supporting older adults When our Alexandria Lakes Area Connected Communities pilot started, Olivia Mastry from The Collective Action Lab facilitated a wide-ranging discussion among project partners, including executives from Alomore Health, Horizon Public Health, Lakes Area Age Friendly, Dancing Sky Area Aging, PrimeWest Health, West Central MN Communities Action and UCare Medicare Advantage health plans. She challenged us to put the older adult at the center of our planning and to imagine new ways of working across professional boundaries to support healthy aging. What emerged was an ambitious plan to identify our area’s service providers and gaps in the five key areas of social determinants of health: health care access, lifelong education, economic stability, neighborhood and built environment and social and community context. “For too many older Minnesotans – especially those living in remote rural communities – the prospect of healthy aging diminishes in their later years,” said Ghita Worcester, Senior Vice President of Public Affairs and Chief Marketing Officer. “Through this pilot project, we are creating integrated hubs of essential resources to help people recapture their sense of a life well-lived. We are excited to join this community collaborative bridging gaps to ensure optimal health and wellness.” Early in our Connected Communities pilot, we identified more than 500 service options in our region that support seniors; despite that, most area residents are unaware of these resources. I have spent my career in senior care, and even I have been surprised to learn about all of the organizations dedicated to helping older people with services such as transportation, socialization and chores around the home. One solution we created is an Age Well Navigator who is connected to local resources. She can assist in supporting an older adult recovering from a hip replacement or help set up remote monitoring and telehealth services so that a person can continue living alone at home safely with appropriate supports and resources. This navigator lives in the area, knows who to call for various types of services and is connected via electronic health records to local health care professionals. Another program component is an Age Well Care Manager who works with seniors to help them craft an individualized plan—for managing their clinical risk as well as increasing social engagement, if needed. This professional is a licensed social worker by training, works with local nurses for clinical expertise and is skilled at coordinating across health care partners, community-based organizations and aging services providers.

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It takes a community-wide effort

and a care manager that are locally focused. We have been able to launch conversations with new insights that have not previously been considered by payers providing Medicare Advantage and Dual Eligible (Medicare and Medicaid) health plans such as Prime West and UCare. Having these representatives at the table during the design phase of our project has increased the flexibility to use the ingenuity of our local experts to create a solution to the triple aim of improved quality, reduced cost and enhanced engagement.

This is no small undertaking. As a community leader, I am often in meetings with my colleagues across many disciplines. We are used to solving problems together. The COVID-19 pandemic has highlighted how interconnected we all are and how much our neighbors rely on us for their well-being. As a collaborative, we are applying lessons learned from this chaotic time such as the increased acceptance of telehealth and the desire for home-based care to improve the Providing access to care and aging experience in the Alexandria area. housing in the area where

By pioneering a more integrated, coordinated and connected way of navigating aging, we are making aging adults the priority that they deserve to be. We are treating them as vital components of a healthy and balanced community. Imagine a way that encourages our elders to have greater self-worth as they age by more easily caring for the entire person. We still have much to learn, but we know we are on a good path to serving community members as they age in ways that foster their best lives as they define it.

people have lived their entire lives is important.

We believe that providing access to care and housing in the area where people have lived their entire lives is important. It allows them to stay connected to their families, friends, churches and communities. Maintaining those relationships is key for healthy aging. The longer aging adults are able to meaningfully participate in the community, the longer they will experience a higher quality of living. Residents in rural areas have often invested their lifetimes in the well-being of their towns. They have raised families, built businesses, mentored young people and have literally, in many cases, helped to shape the communities we enjoy today.

What if? We are experimenting. There is no guarantee this new approach will work for everyone. But what if an older patient of yours moved to the Lakes Area for retirement, and your staff was able to connect them with our Age Well Navigator to introduce them to local health support resources? What if you knew there was an advocate who could support your patient through the complicated ecosystem of health care and relieve your concerns regarding addressing the whole person needs of your patient? Getting older is a huge transition for all of us. Many people get help with the financial planning for their retirement years, but as a society we don’t spend much time on preparing for other aspects of aging. This can range from what happens when an older person needs to quit driving, how well they recover their mobility after joint replacement or how to arrange for meals to be delivered when cooking at home is not safe anymore.

Mark Anderson, MBA, is the President and CEO of Knute Nelson, a senior housing and home and community-based services organization based in Alexandria, Minnesota. He has served in the longterm care industry for nearly 25 years and serves as Past Chair of the LeadingAge Minnesota Board of Directors.

CELEBRATING 30 YEARS OF PROVIDING CREATIVE PLANNING & DESIGN SOLUTIONS FOR EFFICIENT, PATIENTCENTERED HEALTHCARE ENVIRONMENTS

Another example of planning ahead is encouraging family discussions about advanced care options. As health care professionals, we see families and their loved ones during some of the most stressful times of their lives. In my career, I have seen what a difference a health care directive can make when literal life-and-death decisions are made before a health set-back or crisis occurs. That is why one of the priority initiatives of our collaborative is working with a local organization, The Written Gift, to assist with advanced care planning.

Living our best lives These are still early days of our Connected Communities project. The first local seniors are working with the Age Well Navigator and our Age Well Care Manager. We have launched a new digital service for older adults in our area that can provide tablet devices, vitals monitoring, digital literacy training, personal safety alerts and ways to connect with family as well as health professionals. Over the next year, we expect to work with 200 older adults or caregivers in our five-county area, connecting them with navigation help

Hennepin Cty: 1800 Chicago Avenue Triage Center | Minneapolis, MN CONTACT:

Mark L. Hansen, AIA, NCARB, LEED AP mhansen@mohagenhansen.com | 952.426.7400 mohagenhansen.com

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MN

MINNESOTA HEALTH CARE ROUNDTABLE

54

TH

SESSI O N

Care Transitions Improving the safety net

The following report from the 54th session of the Minnesota Health Care Roundtable continued on the theme of our last program, which focused on improving the interoperability of care teams. In this session, we are looking specifically at the topic of care transitions. As the scope of care teams expands, with an increasingly varied number and type of healthcare providers involved, the opportunity for unintended consequences also expands. Care transitions have become a leading source of malpractice litigation. Our panel discusses these issues and how best to address them. We extend our special thanks to the participants and sponsors for their commitments of time and expertise in bringing you this report. This fall we will publish the 55th session of the Minnesota Health Care Roundtable on the topic Care Coordination. This will complete the exploration of a trilogy of emerging and related responses to the necessary evolution of healthcare policy. We welcome comments and suggestions. The term care transition covers a lot of ground. Please tell us what this means from your perspective. DR. SCHULTZ: Care transition is a term that describes the process of

information exchange when patients move between medical practices. Successful transitioning of patient care from one medical practice to another requires quick, efficient and thorough interchange of health information between medical providers. Interoperable electronic health records were supposed to make the process of information exchange between medical practices seamless, but this has not happened in any consistent manner.

TODD ARCHBOLD, LSW, MBA

joining PrairieCare in 2006 Todd became chief executive officer in 2020. He has helped develop one of the region’s largest psychiatric health systems with 12 locations in Minnesota. He is also the executive director for the Psychiatric Assistance Line (PAL) – a statewide service aimed towards increasing collaboration and support between psychiatry and primary care.

BONNIE LAPLANTE, MHA, BS, RN

is the health care home (HCH) program director, in the Health Policy Division, at the Minnesota Department of Health, where she has worked for over nine years. She has 16 years of leadership experience as a clinic services nursing director, as well as experience as a director of a home health agency and a coordinator in long term care.

LINDSEY SAND, LHSE, NHA serves as vice president of population health for Knute Nelson, an aging services organization offering a full continuum of services across more than 35 counties in northwestern and central Minne­ sota and eastern North Dakota. She serves on the boards of Lakes Area Age-Friendly, LeadingAge Minnesota and the LeadingAge Minnesota Foundation. DAVID S. SCHULTZ, MD, MHA is the medical direc­ tor and founder of Nura Pain Clinic. Dr. Schultz is a board certified anesthesiologist with additional board certification in pain medicine from the American Board of Anesthesiol­ ogy, the American Board of Interventional Pain Physicians and the American Board of Pain Medicine. He has been a full time interventional pain specialist since 1995. DAVID J. VOLLER, MBA, FACHE

is the clinic administrator at Shriners Children’s Twin Cities. His 30year career in health care includes positions at the Mayo Clinic, Gillette Children’s and BWBR. David is a Fellow of the American College of Healthcare Executives, sits on the board of ACHE MN and chair for membership and advancement.

LINDSEY: From our perspective, care transitions can be viewed in two ways. It

can refer to the transitions of a patient from a hospital to a skilled care facility or even to their home where patients could utilize skilled care, personal care or independent self-management. It can also refer to health status changes. No matter their current care location, the patient may require more extensive care or less intensive service delivery. This type of transition can involve a health status setback on the road to recovery or new development that may require adjustments to the care plan. BONNIE: Care transition covers a wide spectrum in primary care. Broadly, it means the transfer of care from one setting or level of care to another–for example, from a hospital to home or a residential care facility with return of care to the primary care provider. In certified Health Care Home clinics, transition procedures are developed and used to ensure safety and to prevent health complications, gaps in care and rehospitalization. DAVID: The definition of care transition really comes with two factors that represent care collaboration and coordination while the patient is in our care,

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MAY 2022 MINNESOTA PHYSICIAN

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but also the intentionality of what that care will look like when the patient is not in or not longer going to be in our care. This process starts immediately when the patient is presented. This care transition can occur either internally with other providers or externally with referring or primary care providers.

BONNIE: Poor transitions threaten patient safety, decrease consumer confidence

TODD: Care transition is inevitable. It can range from simply changing care

DR. SCHULTZ: In the ideal situation, when a patient is referred or chooses to schedule as a new patient at our pain clinic, the first touch is typically a phone call during which an appointment is made by our telephone staff. Once the patient is registered in our system and the appointment made, medical records from the referring provider, or from previous relevant medical care, should move into our electronic medical record with minimal hassle and work for our business office staff. Unfortunately, this is not what happens.

providers, moving between levels of care, seeking specialists and discharging from a hospital. Care transition can signal progress in one’s condition, or conversely, it could be the advancement of a disease. It can also be prompted by misdiagnosis or inadequate treatment. In each of the situations, a health system’s ability to effectively manage the transition of care is a critical component to the triple aim and an ethical responsibility of individual care providers. What are some of the most common problems that arise from care transitions?

in the healthcare system and waste resources. Poor coordination during transitions can result in confusion about the patient’s care, duplicative tests, medication errors, delays in diagnosis and lack of follow through on referrals.

By regulation, the patient must sign a Release of Information form, and this must be on file at the referring and/or sending medical practice before information from that practice can be sent to us. We can’t obtain a patient signature over the telephone, and this often complicates transfer of information.

LINDSEY: It all boils down to communication and clarity, especially when multiple providers are involved. Often there is a lack of transparency within communications between caregiver groups Here are more frustrations we encounter which becomes problematic for many reasons, with new patient referrals that could negatively not the least of which is everyone wastes time impact patient care: True interoperability is key to duplicating effort. It is vitally important that there be clarity in expectations between provider groups. • Incomplete health records is the single improving care transitions. Do all care partners know of the array of resource biggest problem. —Todd Archbold options available in a community, and if we do, • Unrecognized medication conflicts because we do we all understand how to identify whether our do not have a complete medication list. patients’ needs align with the skill sets of these • Duplication of testing because we cannot providers? It can be disastrous for our patients determine what testing has been done. when they are transitioned to a level of support that • Difficulty reaching the referring provider after the consult to does not align with their needs, whether lower or higher than is required for the discuss the case. patient. Either way, it leads to wasted resources and frustration for all involved. • No referral received before we see the patient. DAVID: There are mainly two problems with doing transition of care well.

These are the interoperability of sharing information in disparate EHR systems and the other with providers who haven’t been well versed on how to facilitate the transition of care with other provider resources. TODD: The transition of care as it relates to psychiatric treatment is often the

most vulnerable and the most flawed. The shortage of mental health providers, coupled with the demand for services, creates strain on health systems that does not exist in any other area of healthcare. The lack of fair reimbursement and gaps in coverage create major barriers to successful transitions of care for those with severe or co-occurring psychiatric conditions. This is a systemic failure of U.S. healthcare policy and partially due to the fallacy of parity.

• Referral received, but it has incomplete information. It should include the reason for the consult with adequate detail, such as “Patient is being referred for back pain radiating to legs. Has been assessed and deemed not candidate for surgery. Please evaluate and treat pain using all appropriate means.” • Recent clinic notes and relevant test and imaging results not included. It is very often difficult to reach the referring provider to discuss the case. It would be helpful to have the referring provider’s cell phone number since calling clinic numbers means a wait on hold and often no contact with a provider.

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MINNESOTA PHYSICIAN MAY 2022

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MINNESOTA HEALTH CARE ROUNDTABLE

How is your organization working toward solutions to these problems? DR. SCHULTZ: We are assigning extra staff and creating additional workflows to make sure our providers have all the relevant medical information inside of our EMR before the patient encounter. This additional staff time is costly and requires a lot of manual work and rework.

On a more personal, peer-to-peer note, our providers try to reach the referring provider when possible right after the consult to discuss the case directly. Connecting with a busy referring provider in the middle of a busy clinic day is time-consuming and frustrating however for both our provider and the referring provider. We try to contact the referring provider by phone for new patients but this is difficult and time-consuming. We generate a summary letter from our EMR that goes out to the referring provider. We call outside providers who are on the ROI for important information that cannot wait for mail. DAVID: As a pediatric orthopedic care provider

including the patient. Communication should be patient-centered with regular followup communication by the care team and support from a care coordinator if needed. The primary care provider should be notified upon discharge from the hospital or other transitional care, and a followup appointment scheduled within 7-10 days post discharge. For patients discharged to home, we encourage in-home visits by a pharmacy student, community paramedic or community health worker to ensure a patient can follow their medication plan and safely manage at home. What are some of the most common problems related to care transitions beyond your organization’s ability to address? LINDSEY: The overwhelming problem is funding

and how funding for patient care is mapped. Resources provided to acute and clinical care delivery are critical; however, if much of the budget is directed to downstream care, there is minimal left for the support systems required to keep patients from returning into the care cycle. We must find ways to support the whole patient and connect with resources and services that can help them maintain optimal well-being. We need to consider the longevity of these services and prepare for a future where there will be an increased patient demand, especially among our rapidly growing older adult population. Working to direct funding to support our patients outside of the clinical environment is an important goal for us all.

who works with simple fractures to very complex patients, we not only recognize the importance Confusion around medication of care transition but, fundamentally, have care coordinators in our operations who recognize is common. the bidirectional aspects of what makes this work —Bonnie LaPlante well. Part of the role of the care coordinator is to be aware of each step that can involve a transition of care and advocate for the patient as needed TODD: The shortage of mental health providers to insure that mistakes do not occur during and lack of local infrastructure results in access transitions. It is through that intentionality that issues and barriers to needed placements. Much the system structure essentially drives the behaviors of our care team. of this is due to inadequate funding and investment in services. LINDSEY: We believe that collaboration and organizational humility are DAVID: The most common problems we encounter are the ones that have essential. We focus on the strengths of our patients, their caregivers, our happened upstream from the point when the patient comes under our care. healthcare providers and our community-based organizations. We want These are mostly related patients whose previous providers have struggled patients to be connected to the most appropriate and person-centered with a lack of resources and continuity in the care they have provided. We resources. Our organization has developed local resource navigators that see issues that have occurred because there has been poor planning around work with the clients to achieve this. The healthcare ecosystem in every transitions and a failure to recognize that a patient’s health may involve much community can be surprisingly larger than anyone would think, but also very more than care from a single provider. We see patients who may come from complicated to navigate. We have no business making things more complex a relatively great distance and sometimes end up with issues that could have than we already have. Humility is something our industry struggles with, and been preventable or treated closer to home with a better awareness of the care we must make changes to ensure better outcomes for our patients. transition process. TODD: PrairieCare has designed a continuum of psychiatric health services BONNIE: One of the biggest problems is seamless information exchange to that allows patients to receive varying levels of care within the same system, alert appropriate care team members about a patient’s care transitions and often at the same location. We remained challenged by limitations with the plan of care. Despite advances in technology, we do not communicate capacity and lack of viable funding for outpatient services. We continue to well across health systems and community services. Also, in some parts develop partnerships with other medical health systems and mental health of the state, community services are simply not available for patients who providers alike to create more seamless transitions in care. We also supported lack family or friend support and need help with medication management, the statewide psychiatric assistance line (PAL) that allows any healthcare nutrition, transportation and other resources needed to stay healthy. provider free on-demand access to mental health triage and case consultation with a board certified psychiatrist. BONNIE: Health Care Homes primary care clinics focus on improving care

transitions with consistent and clear communication between all team members,

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Confusion around medication is common. Medication instructions are not always clear, and patients have difficulty discerning between a generic and a brand name medication. If there is more than one provider involved


in care, medication instructions can vary, making it difficult for the patient to follow directions. DR. SCHULTZ: Some issues include important health status data that may not

arrive at our practice in time for the patient encounter, including: • When a patient comes to Nura from an oncologist, orthopedist or other specialty provider. • When a patient goes from Nura to rehab or back to an oncologist. • When a patient goes from Nura to an assisted living facility.

interoperability of medical records would also help. Better insurance transparency and better control of medication pricing could also be addressed at both a federal and state level in ways that better facilitate care transitions. Medications are a very important aspect of patient care, and patients often do not know what medications they are taking. The payers and pharmacies have this information, so having some accessible central database—similar to the PMP for opioids—that lists all active medications for each patient would be great. We would like to see better connectivity among the various EMRs to allow health information to flow more freely among different practices. We would also like to see HIPAA rules adjusted as needed so HIPAA does not interfere with doctor to doctor communication about mutual patients.

• Hospital discharge information. We may not have a complete history since information from the patient is often incomplete or inaccurate in detail.

LINDSEY: TMedicare Advantage demonstrates

Are there legislative solutions to the problems around care transitions? TODD: The state legislature has made the topic of mental health in our communities a priority and has invested deeply in start-up funding. However, the focus must be on parity and sustainability. Reimbursements for mental health services are on average 20% less than the rest of the medical community, and the authorization requirements are usually arduous. For example, an individual with diabetes can easily get access to a nutritionist covered by their insurance plan, yet someone with an eating disorder may have their benefits carved out by their plan, subject to different out of pocket rates, and will need to jump through additional hoops to get access to a nutritionist.

Collaboration and organizational humility are essential.

BONNIE: Legislative changes could improve the reimbursement model for

primary care and care coordination by providing incentives for whole person care using an integrated patient-centered care team approach. Such provisions could provide financial support for taking time to work closely with patients to provide comprehensive coordinated care and to avoid negative health outcomes. Legislative action could also identify ways and funding to facilitate health information exchange and universal referral/care transition system software. Finally, there may be policy solutions to ensure a continuum of care and shared responsibility across organizations. For example, incentives could be put in place to encourage cross-setting integrated care teams to promote cooperation and accountability across health and community organizations. DR. SCHULTZ: Improve HIPPA regulations so that medical care providers

can exchange information more freely. Legislating improvement in the

—Lindsey Sand

through supplemental benefits that funding allotments for social determinants of health can impact the well-being of our older adults. CMS has allowed for plans to have flexibility in service options, and innovative advancements in this area should and will continue. On a state level, Medicaid could be encouraging more value-based reimbursement modeling. Adjustments to the funding model could encourage partnerships through the continuum of care and facilitate the breakdown of the current siloed methods. The current Medicaid waiver system is not sufficiently funded and creates sustainability concerns for providers throughout the state.

DAVID: There needs to be better understanding by government and industry around what needs to be done to address these issues. Things like portability acts and improving interoperability need clear pathways, which unfortunately have been very slow to emerge. The restrictions that we have in how we can practice across state lines can create unnecessary difficulties and limit the ability for a patient to seek the appropriate and needed care.

What are some examples of problems you see with care transitions between entities providing care before or after the patient comes to you? LINDSEY: We need standardized tools that help facilitate the transition of

patients. Providers across the state can attest that we burden our teams and our patients with the many unnecessary and redundant steps systems our siloed approaches to care delivery have created. Patients can get lost, overwhelmed and often forego service opportunities due to our created barriers. We need

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MINNESOTA HEALTH CARE ROUNDTABLE

better integration and mechanisms for aligning because we are exhausting everyone involved–including the patient. BONNIE: One big problem is patients who do not understand their treatment

plan, medications or the need for follow up appointments if they are feeling better. Patients with complex needs often require prompting or assistance to coordinate their care. Care transition is a vulnerable time for these patients. TODD: Successful care transitions occur when providers are proactive in

communication and clear in treatment planning. Another key undertone in care transitions in mental health is the presence of compassion–which is a palpable advantage. Problems exist when care providers fail to share necessary information, which may be complex factors such as historical trauma or social determinants of health. Not all care providers fully understand the breadth and diversity of psychiatric services, so that onus falls on our specialty to provide education on the continuum of care, including access protocols. DAVID: The biggest problem is communication, whether these are structured

through systems that share the record or unstructured in the way care teams talk with each other to facilitate care. DR. SCHULTZ: We see patients suffering more due to unnecessary rehospitalizations and inadequate care in assisted living facilities supporting chronic conditions.

What are some examples of positive systems that have been put in place by your organization or others to address care transition problems? DR. SCHULTZ: An online patient-provider health information access portal

accessible by patients and by providers is a great option that could be made easier and better to allow for seamless transfer of information. LINDSEY: We are fortunate to be piloting a program called Connected

Communities, which allows our organization to facilitate efforts in care coordination, resource navigation and system simplification in our region. Together with community partners, healthcare providers, health plans and older adults, we have begun to implement impactful changes toward improved care transitions and the overall well-being of our community. TODD: We have created patient experience groups and community forums to solicit feedback on care transitions and overall experience. Some of the feedback is tough and seemingly out of our control, but change starts with understanding. We continue to remain humble and optimistic about what we can do to best integrate psychiatric care and healing into the broader frame of healthcare. BONNIE: Integrating a member of the primary care provider’s clinic team

into the hospital discharge team and scheduling the followup appointment before discharge can be helpful. They can alert clinic staff to the reason for the visit and gather important medical information in preparation for the visit. They’ll have information to call the patient if they do not show up for an appointment or cancel the appointment. Another positive example is the use of an ADT (admission, discharge, transfer) notification system to alert primary care providers to follow up with the patient based on established protocols. DAVID: One of the best examples we use and that we have seen colleagues use

is the emerging role of care coordinators. These individuals may be employees of the clinic or hospital, contracted employees, and possibly even living in

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other states, by the clinic or hospital or employees of a third party payer such as an HMO or the state. They can be most effective with the highest level of healthcare training, such as an RN, and when they are actively going to the community and meeting with either patients or collaborative partners. They can assist in helping to proactively identify challenges around improving care transitions and how to overcome those barriers. How can better engagement of both the patient and their family improve the care transition process? LINDSEY: Providing the opportunity for patients and their families to have

a voice is essential. Why would we design programming or a care plan for the patient without the patient at the center? That thinking has created the overly complicated ecosystem that we currently operate in. By creating a person-centered approach, we can aid the patient with their unique needs and address their barriers to optimal health. For instance, a discharging patient may receive orders for outpatient therapy; however, if that person lacks at-home support or is unaware of the transportation programming in their community, they will be unable to attend. Another example involves the swelling use of technology in healthcare. Technology has allowed us to deliver care in unique and essential ways, especially during the pandemic. However, if there are concerns with the digital literacy of the patient, have we taken the time to aid them through this? TODD: In psychiatric healthcare, the patient experience and the patient

outcome may not align, and in some cases, may even be divergent. Making progress towards treatment goals may require having difficult conversations with family members, facing fears and becoming vulnerable with care providers. This may create an uncomfortable experience but result in great outcomes. Conversely, mental health treatment that is focused solely on comfort and connections may produce a positive experience but limited outcomes. Our goal is to better engage with patients and families to align the experience and clinical outcomes and be assured that will continue through care transitions. BONNIE: Patient and family engagement can improve health outcomes. Engaging patients and families through conversation, active listening, consideration of values and preferences and explaining healthcare choices can empower them to invest in their health. By choosing meaningful goals and developing a trusting relationship with their healthcare providers, patients and families are more likely to follow through and have improved outcomes. DAVID: The family and especially the patients themselves can play a critical

role in helping assure that care transitions do not result in unnecessary complication. One way to engage them is through the improved and expanded use of portals that can help keep the patient and caregiver connected. Another engagement tool could employ aspects of the value-based reimbursement model that might even incent patients with lower premiums to take a more active role in their care. What can physicians do to improve the process of care transitions? LINDSEY: Physicians are over-burdened, and they must lean more on the

supports that exist for their patients outside the clinic or hospital. They may not be aware of the range of available support available to their patients, or they may not have the time or energy to flip through the hundreds of brochures that are dropped at their door. Regional collaboration among providers, community-based organizations and community members is


required to relieve physicians and the entire care ecosystem transition barriers and improve care outcomes. We are all stretched extremely thin, and it is time that we begin to work more efficiently and in conjunction with one another. DAVID: They could have details about the care a patient has received before reaching them. This would include care by non-physician providers and they could have details about where the patient will receive care after they leave the physician. Being aware of the patient’s ability to understand and follow medical advice on their own, as well as understanding details about how that patient’s living conditions can impact outcomes, would be helpful. Many times, as much as a physician may want to do these things, there are systemic barriers. Things like incompatible EHR, privacy regulations, inadequate staffing and many others can work against optimal care transitions. Physicians must understand the patient as a whole and that it takes a village to provide whole patient care. We all must understand that it will take this same village to make the changes to the healthcare delivery system that will improve care transitions.

How can tools and services like care coordination and medication management help address the problems posed by care transitions? TODD: True interoperability is key to improving care transitions,

yet it remains elusive for most providers. When health systems can ensure accurate and timely sharing of comprehensive and meaningful information, those coordinating care—even between organizations—and help to optimize the experience and outcomes for that patient. Especially in mental healthcare, where things like lab values and diagnostic imaging are not relevant, the importance of conveying the narrative of the care transition is amplified. BONNIE: Care coordination’s main purpose is

to organize care and share information with the patient and the care team to achieve safer and more effective care. Examples of care coordination approaches include teamwork, medication management and care management. Care coordination activities include communicating and sharing information, supporting patient’s goals and healthcare needs and establishing accountability and responsibility across a team, which helps to improve outcomes.

Patients with a care coordinator experience a We would also like to see Physicians can champion, raise one-on-one relationship that supports the patient HIPAA rules adjusted. awareness and advocate for safe care transitions. and family in organizing patient care and navigating They can support team members in having —DR. David S. Schultz the healthcare system. The care coordinator helps dedicated time to conduct tasks related to the patient learn self-management skills, including coordinating transitions, participate in quality medication management. The care coordinator improvement projects to determine how also helps the patient recognize when medical care transitions are working and implement intervention is necessary to maintain health and, strategies to improve and to measure progress. if possible, avoid hospitalization. Primary care physicians can also build and maintain communication with hospital-based clinicians to facilitate care transitions. LINDSEY: Care coordination and management can make everything run TODD: When transitioning a patient’s care either to or from a psychiatric more efficiently, provide better support for the client and empower the client setting, it is critical that all providers are in alignment with care expectations to make the right decisions for their wellbeing. It breaks down barriers, and treatment goals. A focus on the whole person and not just the psychiatric drives compliance and can simplify care delivery. Effective medication condition will prevent marginalization of the person and their care. Cultural management can address numerous challenges faced by our patients. At factors must also be considered, including any spiritual and religious aspects the time of care transitions, prescription additions or changes are common. of treatment. Helping a patient through these changes is vital. As an in-home provider DR. SCHULTZ: Being certain the patient understands what care they received of many services, I can attest to the common occurrence of walking into so they can personally tell this to their other providers involved in care. If a medication disaster. Examples are medication cabinets full of expired the patient goes to another provider, that provider should know about the medications that were never wholly taken, discontinued medicines that care delivered at Nura. A lot is common sense, but sometimes having a the patient did not realize they were supposed to stop taking, and copies formal process minimizes miscommunication. of medication records from past office visits or hospitalizations that are BONNIE:

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outdated but serve as a patient’s guide. We must recognize the challenges that some patients face with understanding medication adherence and aid them in addressing these. What are some of the ways healthcare disparities create unique challenges related to care transitions? LINDSEY: This is the greatest obstacle. Despite exceptional clinical care, the patient will not be successful if we fail to recognize the personal disparities and determinants of health that patients experience in their homes, social lives and environment. We must marry clinical care with social care and advocacy for equity in our organizations, regions and across healthcare. This begins with raising awareness, improving cultural competency, ensuring access to necessary care resources (even if it may involve unique approaches, such as technology) and, once again, collaboration. We must elevate the standards in all state regions to ensure our entire population’s needs are addressed equitably.

and health outcomes. Let’s strive for greater collaboration and recognition of one another and strive to break down silos and barriers to care. BONNIE: Successful care transitions require intentionality and patientcentered care delivered by an integrated team to ensure that the patient remains safe and free of complications during a care transition. That means finding ways to fully understand each patient’s unique situation and designing care and support to help them be successful. It’s not something we can take on in silos. We have to work together. It’s the right thing to do to improve health outcomes. DAVID: At the end of the day it should have nothing to do with us but everything to do with the overall health of the patient/community. Care transitions involve developing partnerships along whatever continuum of care a given provider or provider group is involved in.The partnerships must have clear communication around expectations and capabilities. They must be adequately developed and reach far enough, realizing that not every patient will need every resource but, resources… for every possibility need to be in place. In the end, having these partnerships in care makes everyone’s job easier.

DAVID: Problems with healthcare disparities often originate with economic considerations, such as the ability to pay. Despite numerous TODD: While the U.S. has one of the world’s Care transition should really assistance programs, some people may either most innovative healthcare systems, navigating have nothing to do with distrust them, be unaware of them or simply its various components is overly-complicated unable to navigate them on their own. payment, but it often does. and challenging. A patient suffering from acute Even with navigation assistance they can be or chronic health conditions should not have to —David J. Voller overwhelming. Care transition should really shoulder the burden of care navigation. Those have nothing to do with payment, but it often suffering from psychiatric illnesses are often does. There is no question access to care is carrying additional stressors, which impact one’s impacted by affordability issues, which can ability to manage care transitions and follow through on medical advice. have a distinctly limiting impact on how active a patient may be in the The costs associated with untreated psychiatric illness and improperly system of provider resources. treated co-occurring conditions is extraordinary, and effective care TODD: We know that patients are about 50% likely to follow through transition is a critical step, maybe the most critical, in ensuring positive with referrals to mental health providers. When transitioning between care experience and outcomes. Health system and insurance companies must providers and different organizations, the referring provider or health system accept this responsibility and prioritize helping patients manage transitions has an obligation to ensure that potential barriers such as transportation or successfully as a core part of the care itself. insurance coverage are considered. In cases where health disparities exist, the I’ve often talked about the gap where the money isn’t. Providing importance of successful care transitions is magnified. treatment for diagnosed psychiatric conditions within our clinics and BONNIE: Patients who are vulnerable or at-risk often have poor access hospitals are covered. However, many patients require additional support to care and may be underinsured or not insured at all. Lacking access to to navigate care that has no way of being funded. Care navigation services routine care, they may have untreated medical conditions, putting them at and case management are accessed differently by payer source or county of risk for chronic disease and acute health episodes. Other social factors, such residence. Access can be confusing or arduous, meaning many don’t receive as housing and employment stability, transportation and health literacy this support at all. Many outpatient services are poorly reimbursed, and contribute to health disparities. All these factors need to be considered intensive services like psychiatric residential treatment facilities (PRTFs) during care transitions when patients are most vulnerable. are not even covered by most commercial insurance in Minnesota. As long as these gaps exist, the onus and the honor of care transition will remain Is there anything else about care transitions that you would like with providers. to discuss? LINDSEY: I’d like to reiterate the importance of elevating all health and community-based care providers’ significant roles in our communities. We are all part of the care safety net and play an essential role in patient well-being

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MAY 2022 MINNESOTA PHYSICIAN


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PATIENT PERSPECTIVE

The Impact of COVID on People with Disabilities A need for proactive planning BY JOAN WILSHIRE, MPA

P

eople with disabilities, or who have chronic medical conditions, or both, have faced increased and not surprisingly undocumented hardships during the COVID pandemic. Fear and uncertainty are two words that may best describe the feelings it has caused in many people among the disability community. Even though we see the death rates going down and mask mandates being eliminated by most states, the pandemic has not ended yet. The fear and uncertainty leads to further isolation for many in this community. This continued isolation may result in people with disabilities becoming more disabled. In all honesty, a secret killer of this pandemic could well be the isolation of people with disabilities.

The fear is real Even with vaccinations, booster shots and new antivirals coming out there is still much fear within the disability community. It’s an invisible threat, since we don’t know who is infected or who is contagious. We don’t know how the COVID infection will affect us, or how long it will last. People with disabilities have been hiding for the last two years; it’s like playing a game of hide and seek with the coronavirus. As the isolation continues, it is not surprising for

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people with disabilities and/or with chronic medical conditions to fear being left behind. Historically, people with disabilities have been left behind during natural disasters like floods, tornadoes, hurricanes and pandemics. They have come to expect it. A prime example of being left behind is the vaccination priority guideline developed last year. People with disabilities who have chronic medical conditions were not necessarily high on the list because priorities were based on age. The vaccination priorities seemed to say that people with disabilities were an afterthought and nobody ever wants to be an afterthought. You can really see what it is like to be an afterthought when there’s been little consideration for you, there’s no protocol for you and no way for you to have a voice in the process either. I was not eligible to get my first vaccination shot until April 1. In the room where I sat waiting for the injection, several people were using oxygen, some were in power wheelchairs and others were using canes or walkers. Why weren’t all of us on the priority list? At the beginning of the pandemic, people with disabilities worried “would my life as a person with a disability be deemed valuable enough to live” if there is a shortage of resources? Some people with disabilities are dependent on ventilators to live. If ventilators are scarce, are we going to have to give up a ventilator to provide for COVID ICUs? People with disabilities and chronic medical conditions, are affected in many additional ways, such as restricted breathing and speech, when complying with mask requirements. Virtual doctor visits might not be appropriate but health care centers and clinics were closed to in-person visits, accessible transportation was limited by driver shortages, and many COVID testing sites had limited accessibility.

Proactive planning The biggest issue I’ve seen during the pandemic is the lack of proactive planning by the medical community for people with disabilities. People with disabilities who also have chronic medical conditions and test positive for COVID, need to have a proactive plan set up by their physicians because they are at higher risk. Having a plan gives the person some sense of control and protection if diagnosed with COVID. I was fortunate in that my infectious disease physician created a plan for me around what to do if I were to test positive for COVID. I immediately will contact her office to have a prescription for one of the antiviral medications sent to me. The plan gives me a little peace of mind in that at least there has been a discussion of what I need to do in this scenario. Trust me, when I enter a hospital with my variety of medical issues I present a challenge to figure out what should be done immediately. Another big concern is not being allowed to have anyone with me to advocate for my treatment plan. The physician’s plan should be available and implemented immediately. I have been living with MS for many decades. I always have been careful during flu season to avoid the latest influenza and I have been pretty lucky avoiding COVID. I order my groceries, clothes and other household necessities on line. I have had virtual doctor appointments


but there are a few doctor appointments require in-person visits to receive the necessary medical care.

Going above and beyond

homebound. Her game of hide and seek is still very real. COVID has definitely made a negative impact our relationship. Her medical professional created a plan for her that includes taking a newly approved drug that will help her body build antibodies. Now she feels like there is a light at the end of the tunnel.

During the peak COVID surge I had a variety of medical experiences where I have a friend with many autoimmune physicians and nurses certainly went above and conditions, type I diabetes being the most serious. beyond routine care to keep me as healthy and safe She does a great job of taking care of herself, as as possible. In the last two years I’ve had several her diabetes is very much uncontrolled. She knows doctor appointments in my car, literally. You could that a COVID infection could be very serious for call them drive-up or drive-by appointments. I’ve Continued isolation may result her and poses an elevated risk of death. She has had a nurse come out to my car to get the urine in people with disabilities not gone anywhere in the past two years other specimen container to take up to the lab and I’ve becoming more disabled. than 7 a.m. trips to the grocery store. Right before also had the nurses come to my car to monitor an COVID hit she bought a retirement home in implanted device. The best example is the biopsy Phoenix, Arizona. Unfortunately, she hasn’t even I had in my car last year. I have had a history of traveled for a short visit because she just doesn’t squamous cell skin cancer and I had a suspicious feel safe flying. She is concerned that as new spot on my hand. I contacted the doctor and she treatments are developed, as in the earlier vaccine priorities, they won’t be said, “I do not want you to come in the clinic. I will come to your car readily available to help people like her. People with disabilities followed the and do the biopsy.” That is exactly what she did. And yes, it was cancer, age requirements and those who have chronic medical conditions were not so I am grateful we were able to do this immediately rather than waiting. I allowed a higher priority to receive vaccinations. collaborate with all of my physicians on an ongoing basis to keep myself safe from COVID while managing healthcare needs that can not be put on hold. When I told her that I had a plan with one of my physicians, she said, “ That is exactly what I need. A plan would me feel like I have options in I have a sister with an auto immune disease for which she takes a new place to protect myself from COVID.” Another friend, who is mildly affected medication that lowers her body’s ability to develop antibodies. So even though she’s vaccinated and boosted, she does not have enough of the antibodies to protect against COVID. I have not seen her in two years because she has been

The Impact of COVID on People With Disabilities to page 304

Do you have patients with trouble using their phone due to a hearing loss, speech or physical disability? Contact the Telephone Equipment Distribution Program for easier ways to use the phone. Phone: 800-657-3663 Email: dhs.dhhsd@state.mn.us Website: mn.gov/deaf-hard-of-hearing 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 MAY 2022

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3COVID-19 Litigation from page 13 A “qualified person” includes a licensed health professional or other individual authorized to prescribe, administer or dispense covered countermeasures under the law of the state in which the covered countermeasure was prescribed, administered or dispensed. Additional entities would fall under a “Covered Person”, as the Act defines a person as “an individual, partnership, corporation, association, entity or public or private corporation, including a federal, state or local government agency or department.”

Covered Countermeasures A “Covered Countermeasure”, as it relates to this declaration, must be a “qualified pandemic or epidemic product,” a “security countermeasure” or a drug, biological product or device authorized for emergency use. As is relevant to this analysis, based upon the claims we are seeing now and anticipate later, “a qualified pandemic or epidemic product” includes any drug or device specifically manufactured, used or designed to treat or cure a pandemic/epidemic or to limit the harm the same would otherwise cause. This would also include any drug or device used to treat a serious or life-threatening disease or condition caused by or intended to enhance the efficacy of a drug, biological product or device. Note that a Covered Countermeasure must be approved or cleared by the Food, Drug and Cosmetics (FD&C) Act, licensed under the Public Health Services Act or authorized for emergency use under the FD&C. We have already seen this in the context of PPE, respiratory devices and the three available vaccines in the United States.

A product may also qualify as a Covered Countermeasure if it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption defined by the FD&C. Drugs/devices in this category are those that are presently the focus of research conducted to prevent COVID-19. To this end, a provider will likely have to seek approval prior to administration of investigational countermeasures, e.g., COVID-19 vaccines.

Recommended activities “Recommended Activities” are those authorized in accordance with the public health and medical response of the federal, state or local authorities to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. “Administration” is not defined by the Act but has been defined by the Secretary as: physical provision of the countermeasures to recipients or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purposes of distributing and dispensing countermeasures. Examples of “Administration” provided in the declaration include: physically providing a vaccine or handing drugs to a patient; decisions or actions involving security and queuing as they relate to countermeasure activities. Courts must dismiss claims brought against covered entities for any loss relating to “any stage of design, development, testing, manufacture, labeling, distribution, formulation, labeling, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use of a countermeasure.” The act also expressly preempts any state law that “is different from, or is in conflict with, any requirement” established regarding the covered countermeasures. The Declaration states that it is the specific intent of the Secretary to preclude liability claims such as allegations of negligence by a manufacturer in creating a vaccine or negligence by a healthcare provider in prescribing the wrong dose.

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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

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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

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The Declaration goes as far to state that liability claims such as slip-andfall injuries or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location are precluded as they would relate to the management and operation of a countermeasure distribution program or site. However, if the claim is not directly related to a countermeasure activity, which we anticipate will be a point of dispute in any future litigation, no immunity would apply.

Causal nexus to a covered countermeasure As with any negligence claim, there must be a causal link between the “covered countermeasure,” the “recommended activity” and the injury at issue. The most basic example of this would be someone suffering a bodily injury from a COVID-19 vaccine or from complications of COVID-19 treatments. Based upon guidance provided by HHS, immunity would extend to the decision-making process for purposes of allocating and administering PPE in the context of an infection control program. We see the latter arise when there are claims that a patient/resident contracted COVID-19 within a facility during the height of the pandemic when there were PPE shortages. As with each aspect of PREP immunity, a determination should be made at the earliest stages of litigation as to whether there is a causal relationship between the loss asserted and the covered countermeasures being used or


administered. In some circumstances, this may require additional information and potentially limited discovery for purposes of asserting suit immunity.

• What does it apply to? Does it apply to direct COVID-19 treatment or preventative measures taken?

Exceptions and remedies for the injured

• Is the immunity/defense conditional to compliance with state or federal guidance? Often the provision will not address the impact of different or conflicting guidance. It will also not distinguish between “strict” or “substantial” compliance. These are likely where the applicability issues will be litigated.

The declaration notes that individuals who sustain a “serious injury” or die as a result of the administration of a Covered Countermeasure are eligible to receive benefits from the Countermeasures Injury Compensation Program (CICP). In order to obtain these benefits, the individual is required to show “direct causation” between the Covered Countermeasure and a serious physical injury with compelling, reliable, valid, medical and scientific evidence.” Notably, the immunity conveyed under the Act and which has been preserved pursuant to the COVID-19 declaration does not extend to “willful conduct”. Willful conduct is defined as an act or omission that is taken intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. In these instances, the Act designates the Federal District Court for the District of Columbia as the proper venue for these claims to be heard.

State-based immunity and defenses available At the time this article is being written, 38 states have passed some executive or legislative action providing defendants with immunity or an affirmative defense to liability; some have already expired, but should be applicable for specific timeframes. Although each state will be different, there are some common features to look for:

• Who does the immunity/defense apply to? Is it “health care providers” or “health care facilities”? How are these terms defined and distinguished within the provisions? Nearly all of the state immunity provisions will provide exceptions for “gross negligence” or “recklessness.” As anticipated, plaintiffs have attempted to circumvent the immunities and defenses provided and attempt to couch their claims as non-COVID related. Be aware of this tactic, but do not be afraid to assert the defenses available at the earliest stage in litigation. Attorneys who are experienced in defending COVID-19 litigation will likely have pleadings, discovery and briefs that may be applicable to the claim. They will also be more educated in federal/state-specific immunities and can provide an efficient and cost-effective claims investigation process. Sandra M. Cianflone, J.D. is an attorney with Hall Booth Smith, P.C. which specializes in health care law.

• When is the immunity/defense effective? Generally, the provisions will be effective as of the date of the local emergency declaration.

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3Moving Medical Education Beyond the

Several years ago, we built our beautiful Clinic and Specialty Center (CSC) in downtown Minneapolis. It has allowed to us centralize our primary care and subspeciality clinics into one downtown setting. In addition to the primary care clinics located throughout the metro, has helped us provide better access to residents of Hennepin County. The CSC incorporates many local artists’ work and has an abundance of natural light; it feels like a healing environment right when you enter. The onsite parking, new operating rooms and bigger clinic spaces allow for a better experience for our patients.

Physician burnout is definitely impacting our physicians, our residents and even our medical students like never before. Research has shown that psychological wellbeing connects to several pillars including autonomy, competence and relatedness. Medicine is no different. Medicine has pushed productivity—the movement to see more patients in less time. This has made patient care more of a transaction than a connection. The pandemic added new challenges: exhausting work, the lack of a playbook and available treatments, coupled with a feeling of powerlessness both in treating patients with infection and watching others unable to access their primary care, necessary procedures and critical addiction and mental health support. Our mitigating interventions have centered around building back autonomy in clinical schedules and work, offering easy access to mental health services and fostering onsite connectedness and belonging.

The pandemic has stretched the concept

HCMC has many unique partnerships

of physician burnout well beyond what

with both large and small organizations

was already a significant issue. What are

providing health care. What can you

some of the ways you are addressing

tell us about some of these and what

these concerns?

future partnerships may be in store?

Classroom from page 9 What changes in how you can provide care have the recent extensive expansion of the hospital made for your patients?

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MAY 2022 MINNESOTA PHYSICIAN

Our community partnerships are critical to our mission, our success and ability to transform healthcare in ways that benefit our patients well into the future. One of the exciting directions I see is related to our commitment to diversity and inclusion at Hennepin. Our Chief Equity Officer, Dr. Nneka Sederstrom, has helped to build a pathway that introduces high school students of color to health care professions and professionals at Hennepin. We are also building business relationships with minority businesses in the community. We all do better when working together. Meghan Walsh, MD MPH FACP is the chief academic officer at Hennepin Healthcare, the associate dean for affiliate hospitals, and an associate professor of internal medicine at the University of Minnesota School of Medicine. She has worked as a hospitalist for over 15 years.


3Co-opetition from page 11

topic of COVID vaccine health disparity issues. Working with the MN Department of Health, they found remarkable success. This work could translate to address other issues, such as disparities in behavioral health access, but it could also expand and redefine co-opetition in new ways. Innovations in reimbursement, providing incentives to address work force shortages, might be an example.

Takeaways

There are several benefits to co-opetition, and in health care the most important one is improved patient outcomes. These may manifest in many ways, including increased access to care, whether geographically or through more affordable care. Co-opetition does not preclude continued competition, but it implies sharing strengths. It can allow smaller organizations to compete with larger ones by sharing workloads The term co-opetition probably or workforces. Another benefit can come through does not resonate in the increased marketplace penetration through both vocabularies of most reaching new patients and improving the standards health care leaders. of care. As the pace of innovation in health care technology expands exponentially, co-opetition can provide a basis for developing and incorporating best practices around change management. As the costs of health care continue to rise, the current health care delivery system will be forced to find new ways to operate; expanding the role of co-opetition will be part of this. We are seeing exciting examples in new medical facilities construction. Health care workforce shortage issues are at a serious tipping point and it may be through co-opetition that some solutions to these problems arise.

While co-opetition might be a consideration for your organization as you think about future strategies, it is a mindset you have to embrace as well. Competition does not have to be the evil that is often warded off by counter moves, it can be mutual gain for all, especially the consumer who has more of a final say. David J. Voller, MBA, FACHE is currently the Clinic Administrator at Shriners Children’s Twin Cities. His 30 year career has all been in healthcare and health care related services which includes,

Mayo Clinic, Gillette Children’s and BWBR. David is a Fellow of the American College of Healthcare Executives, sits on the board of ACHE MN and Chair for Membership and Advancement. He has been published and sat on numerous panels addressing the advancement of health care delivery and services helping to transform the industry to better serve the needs of the consumer.

Recently, health plans in Minnesota, which compete fiercely between themselves for market share, came together to share resources around the

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3The Impact of COVID on People With Disabilities from page 25 by Cerebral Palsy was sick with COVID last fall. He told me about feeling extremely fatigued and losing his senses of taste and smell. He just didn’t want to eat and had to remind himself to continue to keep his nutrition intake going or he would be too weak to even try to do anything for himself. I asked him if he called his doctor and he said that he did not. He was surprised that the COVID infection made his Cerebral Palsy symptoms, especially spasticity, worse. There hasn’t been enough conversation regarding additional challenges people with disabilities face when they get COVID. Talking to a medical provider could help them plan for possible effects that are specific to their personal medical needs. We need physicians to help guide some of this discussion. No assumption should be made that they have accessible transportation to clinics, that they have adequate personal care assistance or have access to over-the-counter medicines to combat COVID side effects.

faces uncovered. But people with disabilities who have chronic medical conditions look at this as an ongoing time of uncertainty. During the pandemic there have been many challenges for everyone, but even more so for people with disabilities. These challenges may include the inability to wear a mask or lack of communication tools and barriers to visiting health centers for COVID testing or vaccinations. Trying to figure out accessible transportation to a medical clinic or hospital has been more difficult because of COVID restrictions. The good news is we are moving into the next phase of the pandemic where we will continue to see fewer cases. However the pandemic isn’t over yet which means the fear and uncertainty will persist among people with disabilities. We will all need to continue to be safe and to partner with our providers in ways that consider more specialized health care needs.

Moving forward

Joan Wilshire, MPA, is a disability inclusion specialist and president

Now that more and more states and cities are lifting the mask mandate, individuals with no underlying medical conditions are ecstatic to have their

of Wilshire Consulting LLC. Prior to this she served for 15 years as executive

Assessing the Negative Impact The National Council on Disability (NCD) recently issued a report that examines COVID-19’s disproportionate negative impact on people with disabilities across seven critical areas releasing findings and recommendations. For decades, federal and state healthcare data collection practices failed to capture baseline information about the functional disability status. This data dearth created barriers in collecting real-time accurate data about the impact of COVID-19 on people with disabilities and the healthcare disparities they experienced.

Findings COVID-19 exacted a steep toll on people with disabilities, posing unique problems and barriers. People with intellectual or developmental disabilities, and medically fragile and technology dependent individuals, faced a high risk of being triaged out of COVID-19 treatment; were denied the use of their personal ventilator devices after admission to a hospital; and at times, were denied the assistance of critical support persons during hospital stays. Informal and formal Crisis Standards of Care (CSC) targeted people with certain disabilities for denial of care. Limited opportunities to transition out of congregate settings to communitybased settings revealed continuing weaknesses and lack of sufficient Medicaid Home and Community-Based Services (HCBS). People with disabilities and chronic conditions who were at particularly high risk of infection with, or severe consequences from the virus, were not recognized as a priority population by many states when vaccines received emergency use authorization. Both youth and adults who had mental health disabilities that predated the beginning of the pandemic experienced measurable deterioration over its course, made worse by a preexisting shortage of community treatment options, effective peer support, and suicide prevention support.

Recommendations Include Healthcare Congress or the Department of Health and Human Services (HHS) should require all hospitals and managed care plans that receive federal financial assistance to increase public transparency of, and nondiscrimination and due process within, crisis standard of care (CSC) guidelines and medical rationing policies adopted during public health emergencies and emergency surge situations. HHS’ Office for Civil Rights (HHS OCR) should develop a Patient’s Bill of Rights for People with Disabilities.

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MAY 2022 MINNESOTA PHYSICIAN

director of the Minnesota Council on Disability.

Congregate Care Facilities Appropriate government agencies should develop and implement a strategy to mitigate the risks of infectious disease transmission in CCFs and address the civil rights concerns that impact the lives of people with disabilities in CCFs. Centers for Disease Control and Prevention (CDC) should emphasize CCF census reduction as an infection control strategy by expanding its guidance beyond long-term care facilities (LTCFs) to include all CCFs and emphasize that reducing the census of CCFs through accelerating discharges and diversions is a critical strategy.

Education Congress should enact measures that include funds dedicated to compensatory education for students with disabilities who could not receive necessary services and supports during the pandemic and who have experienced disruption and regression in their behavioral and educational goals.

Employment The Office of Personnel Management (OPM) should maintain maximum telework flexibility for all federal agencies on a permanent basis and ensure that federal employees with disabilities receive necessary, reasonable accommodations in their technology while working remotely and retain flexibility to work from their designated federal office as needed or desired.

Effective Communication All federal entities involved in public health, emergency management, and the provision of public announcements or briefings of broad public importance should prepare and disseminate information related to any pandemic or public health emergency in accessible formats, including providing sign language interpretation and/or captions during live and prerecorded video briefings; making all written materials available in alternative formats; and making all online materials accessible.

Mental Health and Suicide Prevention States should expand the mental health workforce and peer support workforce, including through using HCBS dollars and mobile crisis dollars available through the American Rescue Plan and Certified Community Behavioral Health Center (CCBHC) funds. To access the full report please visit: https://ncd.gov/progress report/2021/2021-progress-report


Pictured left to right: R. Scott Stayner, MD, PhD, David Schultz, MD, Peter Schultz, MD, MPH

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