Minnesota Physician • March 2021 by Minnesota Physician Publishing

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MARCH 2021

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THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXIV, No. 12

Stark Law and Anti-Kickback Statute Updates What physicians need to know BY ANTONIO “TONY” FRICANO, JD

n November 20, 2020, the Department of Health and Human Services (“HHS”) published sweeping rule changes to the Physician Self-Referral Law (the “Stark Law”) and the Federal Anti-kickback Statute (“AKS”). HHS previously indicated that the new final rules for the Stark Law and AKS would be not published until summer of 2021, so the announcement on November 20, 2020 came as quite a surprise. Most of the changes took effect on January 19, 2021. Physicians should be aware of the new opportunities and new obligations resulting from these changes

New Value Based Opportunities

Ransomware in the Age of COVID-19 Addressing cybersecurity issues BY MATTHEW C. BERTKE, CPA, MBA 2020 was a year that saw many changes and one that particularly affected the healthcare community. But while U.S. healthcare workers remained on the front lines heroically battling the COVID-19 pandemic, another hidden menace has been steadily increasing in prevalence underneath the radar. As reported by the nonprofit news organization the Vermont Digger, on October 28, 2020, University of Vermont (UVM) Health Network fell victim to a ransomware cyberattack that affected over 5,000 computers and laptops. The extensive attack Ransomware in the Age of COVID-19 to page 104

In 2018, HHS launched the “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing Stark Law and Anti-Kickback Statute Updates to page 124

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MARCH 2021 MINNESOTA PHYSICIAN

MARCH 2021

Volume XXXIV, Number 12

COVER FEATURES Ransomware in the Age of COVID-19 Addressing cybersecurity issues

Stark Law and Anti-Kickback Statute Updates What physicians need to know

By Matthew C. Bertke, CPA, MBA

By Antonio “Tony” Fricano, JD

DEPARTMENTS CAPSULES .................................................................................. 4 INTERVIEW .................................................................................. 8

ON-DEMAND

Insuring the Highest Health of Minnesotans Lucas Nesse, President and CEO Minnesota Council of Health Plans

BEHAVIORIAL HEALTH................................................................. 14 Facing a Psychiatric Bed Crisis When demand exceeds supply

Todd Archbold, LSW, MBA SOCIAL DETERMINANTS OF HEALTH............................................. 18 E-referral Solutions Screening and connecting patients to community services

Reid Haase, MA ADMINISTRATION....................................................................... 20 Clinical Service Lines A training ground for the emerging physician leader

Daniel K. Zismer. Ph.D. TELEHEALTH................................................................................ 24 Digital Health Care A look at growing trends

By Dr. Robert Kantor, MD and Kristi Henderson CARDIOLOGY............................................................................. 28 Bioprinting 3D heart pumps A concept that is gaining traction

By Molly Kupfer, PhD, and Brenda Ogle, PhD

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ART DIRECTOR______________________________________________________ Scotty Town, stown@mppub.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is PO Box 6674, Minneapolis, MN 55406; email comments@mppub.com; phone 612.728.8600;. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.

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MINNESOTA PHYSICIAN MARCH 2021

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Children’s Minnesota Opens New Facility in Lakeville A Children’s Minnesota recently announced the opening of a new specialty center in Lakeville. The new facility, just off Interstate 35 will offer outpatient pediatric rehabilitation services, with plans to add behavioral health services later this year. The new specialty center expands Children’s Minnesota’s presence into the south metro, giving families a more accessible and convenient option for pediatric specialty care. “We are excited to be opening our newest specialty center in Lakeville and helping more families in the south metro get the care they need, where they need it,” said Dr. Marc Gorelick, President and CEO of Children’s Minnesota. “Lakeville is one of the fastest-growing cities in Minnesota. This expansion is part of our efforts to improve patient access

to the high-quality care and services our specialists offer.” Rehabilitation services offered include occupational therapy, physical therapy, feeding therapy and speech therapy. The rehabilitation specialists at Children’s Minnesota use the latest research and innovations to help children meet and overcome the developmental and rehabilitations challenges they may face. Convenience and proximity to a therapist allow families to make regular visits, improving outcomes for treatment. “We understand families sometimes drive long distances in order for their child to work with one of our therapists. A child’s treatment often requires multiple, in-person appointments, which can be challenging for busy families,” said Paula Anderson, director of rehabilitation services at Children’s Minnesota. “This new specialty center in Lakeville allows some of our current patients to get care closer to home and gives us the opportunity

to support even more children who need these important services.”

Sanford Health and NFL Alumni Association Team Up LSanford Health and the NFL Alumni Association (NFLAA), a group of former professional football players announced an agreement late last week to launce a new health initiative called NFL Alumni Health. The NFLAA, formed in 1967 has a core mission of working with former players and their families. Sanford Health provides a wide range of services that will help and enhance the triple goal of this initiative, which includes: • “Caring for Kids” a way for alumni to give back to their local communities by raising money for youthrelated charities. • “Caring for Our Own” focuses on improving the

health and well-being of alumni and their families by providing personal support services and benefits for life after the game. • “Caring for Our Community” focuses on partnerships that support local communities. Successfully addressing these goals involves extensive collaboration. Sanford will assist in serving the health needs of retired players and addressing the concerns of their families. “Our mission is to improve the lives and well-being of the people in our community,” said Paul Hanson, president and CEO of Sanford Sioux Falls. “That’s in perfect alignment with the goals of the NFL Alumni.” Shared work will include elements such as concussion research, repetitive-use injury issues and promoting healthy lifestyles. “We want to create an atmosphere where players who helped build the NFL brand can use

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MARCH 2021 MINNESOTA PHYSICIAN

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our NFL alumni brand to work in their communities and improve their communities,” said NFLAA president Bart Oates. Oates is a threetime Super Bowl champion and fivetime Pro Bowl center. Health issues connected with retired NFL players have become more prominent in the news. Former pros deal with football-related medical challenges that can last lifetimes and involve entire families. The bond between Sanford and the NFLAA was established to address those circumstances and the affiliation will include more than just access to progressive medical advice.

Centracare Awarded Mental Health Care Grant CentraCare recently received a $1.2 million grant from the The Leona M. and Harry B. Helmsley Charitable Trust. This funding helps facilitate their adoption of an innovative care model for adult patients experiencing emergency mental health needs and will help with construction of a new facility. Work has already begun on the Emergency Psychiatric Assessment, Treatment and Healing Unit at St. Cloud Hospital and is expected to be complete by early summer. The new unit will provide faster assessment of those dealing with mental health issues and do so in a unique and comforting setting. EmPATH transitions patients away from the sometimes chaotic environment of the emergency department into a welcoming and calming setting where they can be assessed, observed and receive a tailored treatment plan during their time of crisis. “We’re excited to help bring the EmPATH philosophy to Central Minnesota as Helmsley continues to improve healthcare in rural areas across the Upper Midwest,” said Walter Panzirer, a Trustee with the Helmsley Charitable Trust. Kristin McNutt, Physician Assistant in Behavioral Health at CentraCare – St. Cloud Hospital added “With the opening of the EMPATH unit, we will be

able to offer a space designed specifically to allow room for patients to receive care with dignity”. Nearly 4,000 patients a year seek mental health services through the St. Cloud Hospital Emergency Trauma Center – making mental health emergencies the sixth most common reason for visiting the emergency department. “The ability to implement this unique model of care comes at a time when we are seeing more and more patients seeking crisis-level help for mental health issues,” said Merryssa Wood, Nurse Practitioner in Behavioral Health at CentraCare – St. Cloud Hospital. “The EmPATH Unit will make it possible for us to provide more focused care during a time of crisis and offer support and treatment that can sometimes be limited in traditional emergency department settings due to the focus on physical trauma or other medical emergencies.” In other emergency departments across the country up to 80 percent of patients who utilize the EmPATH Unit become stabilized within 24 hours. Unnecessary inpatient hospitalizations have been reduced and limited inpatient beds are preserved for patients requiring more intensive levels of treatment.

New Hennepin Healthcare Technology Aids Frostbite Victims Physicians at Hennepin Healthcare are utilizing new fluorescence imaging technology that represents a major advance in helping make life and limb-saving decisions with patients with frostbite injury and other tissue perfusion concerns. Stryker’s SPYPHI is a hand-held device used in surgical settings to visualize the quality of blood flow in vessels and micro vessels that provide oxygen to organs. HCMC is the first hospital in the state to implement this advanced technology in an acute setting. “We’ve already realized SPY’s benefits when evaluating exposure patients for frostbite

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MINNESOTA PHYSICIAN MARCH 2021

CAPSULES

injury,” explains HCMC emergency physician Dr. Thomas Masters. “It may help physicians determine when the use of clot-busting medications is indicated, as well as when it’s not.” SPY-PHI uses a near-infrared low powered laser light source to stimulate a fluorescent imaging agent that has been injected into the blood stream. The fluorescent agent binds to the proteins in blood and circulates through the body. When stimulated by near infrared light, the protein-bound agent emits a fluorescence signal which enables visualization of blood flowing through vessels and into tissue. The fluorescence is captured by a special camera, is processed and is displayed on a video monitor for the physician to review. Since the agent is bound to blood, where blood goes, it goes. If there is no fluorescence, it can mean that there is compromised blood flow. “We hope that eventually it may have applications for crush injuries,

necrotizing fasciitis, and other types of wounds,” said Dr. Masters. Unlike traditional bone scans, which can be time-consuming to perform in an emergent situation, SPY technology does not involve ionizing radiation and utilizes a fluorescence imaging agent with a short half-life thus allowing surgeons to repeat perfusion assessment as needed.

University of Minnesota and Mayo Partner with Google The University of Minnesota, Mayo and Google recently announced NXT GEN MED, a unique partnership that will combine world-class technology, research and immersive learning approaches for students pursuing health care careers. This partnership will offer a one-of-a-kind health sciences education program through the University’s Bachelor of Science in Health Sciences degree offered in

Rochester, MN, reducing almost two years from the traditional four-year degree. The program will leverage cutting-edge technology and learning tools from Google that engage students virtually, and will match students with mentors at the Mayo Clinic. “The world of health care is dynamic and exciting. It demands new and creative ways to educate and prepare the next generation of leaders,” said University President Joan Gabel. “As challenging as the times are that we find ourselves in, they also offer us the rare opportunity to try something entirely new. We are thrilled to be working with Google on this first-of-its kind partnership, and we look forward to welcoming our first cohort of students next year.” UMR and Mayo Clinic have collaborated for more than a decade to support the continued growth of Rochester’s global reputation in health care and medicine. NXT GEN MED is an organic extension of that collaboration,

providing experiences for students with the world’s most respected health care organizations. Mayo Clinic is also a top job destination for UMR alums. NXT GEN MED will present students with interdisciplinary challenges that require subject matter knowledge, creative problem solving and data analysis. Its curriculum “gamifies” the educational experience, allowing students to apply their skills and knowledge to real-world problems and positioning them for career success. Classes will blend in-person and remote delivery, with Google Cloud technologies aiding UMR’s innovative faculty to provide flipped, active instruction and experiential elements such as virtual reality.

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MINNESOTA PHYSICIAN MARCH 2021

INTERVIEW

Insuring the Highest Health of Minnesotans Lucas Nesse, President and CEO Minnesota Council of Health Plans What are some of the most unexpected things you have encountered since joining the Council?

What are some of the ways the Council is a resource for consumers?

The Council is a resource for consumers in a variety of ways, including helping Minnesotans gain entry into the health care system, finding the best providers for their specific situation, and ensuring coordinating of care overall. Efforts can also include support for food security, housing, education, and transportation to appointments. You have been working with issues around reinsurance – please tell us about these efforts.

Reinsurance was first considered on the federal level as a necessary tool for market stability under the Affordable Care Act. When that fell through at the federal level, the market was unstable and more costly. Minnesota stepped up with our own proposal and it has performed as advertised — bringing much needed stability and more affordable premiums, 20% lower on

MARCH 2021 MINNESOTA PHYSICIAN

Extending reinsurance is a top priority, and so is a proper permanent expansion of telehealth. Telehealth utilization during the pandemic was a success story thanks to the close coordination that made it work for Minnesotans. The question remains about where it will level off, but the future clearly will have higher utilization of telehealth. That is a good thing because it will support better access and it has the potential to bring more efficiency to care models, as well. What are some of the ways the Council is addressing the topic of health care equity?

“...”

Extending reinsurance is a top priority

“...”

Obviously, the COVID-19 pandemic was a headwind that no one saw coming and I gained the experience of working with the plans to quickly adapt and support their members. The Council has always worked collaboratively to make health care affordable and accessible for Minnesotans, but the exponential growth of telehealth has required particularly close coordination to support continued access to care. The pandemic has also highlighted how important the additional services that the nonprofit health plans provide are for optimal health. For example, there’s been a renewed focus on community giving and our foundations have provided significant financial assistance related to addressing social isolation, mental health, food insecurity, domestic abuse as well as supporting broad availability of personal protective equipment. Organizations receiving financial and other support from health plans include Second Harvest Heartland, Greater Twin Cities United Way, People Serving People, YMCA of the Greater Twin Cities, and many others.

What non-COVID legislative issues are you working on this session.

average, to Minnesota’s individual market. It does so by directly paying for a portion of high-cost claims. We are in year four of a five-year federal waiver and right now we are seeing bipartisan support to extend the program for a fifth year. Reinsurance has been so successful that it should be considered as part of a longer-term solution. Please tell us about your work related to COVID-19.

The health of Minnesotans is the highest priority of the nonprofit plans we represent, and they stepped up immediately for their members. In addition to community giving efforts, health plans took voluntary actions very early on that including waiving any cost sharing for testing and in-patient treatment, broad expansion of telehealth services, relaxed outof-network requirements, and removal of prior authorization procedures. We also work closely with state officials to continuously assess if there are additional steps that can be taken to ensure timely and barrier-free access for Minnesotans, including support for the vaccination effort.

There is a lot of great work going on in Minnesota right now on health equity, but obviously more needs to be done. One of the biggest challenges is driving the close coordination necessary to make real progress. Health plans recently made their senior leaders available to create a Health Equity Committee focused on coordinating a focused effort. As an example of our intentions, at only our second meeting, we were able to unite around a recommendation to update the Universal Initial Credentialing Application Form to include voluntary disclosure of race, ethnicity and language so that information is available to support health equity efforts by identifying diverse mental health providers. That quick and substantial action is just one of many impactful steps we will be advancing to improve health equity in Minnesota. How does the public health work you are doing with community health groups around Minnesota fit in with your health care equity initiatives?

Our plans are engaging with a wide variety of public health initiatives, ranging from mental health to physical activity to environmental health initiatives. Every 5 years, our plans come together to set priority areas for community engagement after reviewing state and local health assessments and outline those goals and partnerships in a Collaboration Plan. Through these initiatives, our plans address health equity in three key ways:

• Creating and supporting a diverse workforce within our organizations. • Increasing access to culturally and linguistically appropriate care.

paid for the drug in any other country. The goal is to put pressure on their regular price increases and scrutinize the reporting to inform the best next steps in supporting affordability.

• Improving quality of care.

What other goals/projects do you have

We know we can’t make everyone healthier on our own, which why we value our work with others in the community and invest in programs that aim to reduce health disparities. What work are you doing around the topic of prescription drug costs?

What could be considered step one in making an impact on drug costs was our successful effort to require transparency regarding drug companies’ price increases. The law generally requires drug manufacturers to report certain information to the state if drugs costing more than $100/month increase their price more than 10% in one year or 16% over two. The information they must submit include the factors contributing to the increase, costs associated with manufacturing, marketing, R&D, sales revenue, profit, any agreements made to delay a generic version, and the ten highest prices

for 2021?

We are always working to find practical and innovative ways to ensure that all Minnesotans get access to high-quality care at the most affordable price. So, in partnership with the Minnesota Chamber of Commerce and the Minnesota Hospital Association, we are working on a High Value Care Initiative to more broadly identify services that are considered to have low or no value and develop protocols to minimize their occurrence. A 2017 Minnesota Department of Health study found that $55 million was wasted in a single year on a small subset of services known to be of low value, which is generally care that is medically unnecessary and can include things like redundant or unneeded diagnostic tests, lab tests, therapy services, radiology services and pharmaceuticals. We are excited to focus an effort here in Minnesota that has great potential to maximize efficient, effective care – and ultimately lower cost.

What would you like physicians to know about the Minnesota Council of Health Plans?

Health plans truly want to work closely with you to support optimal health. I have regular conversations with the leaders of the provider associations that are constructive and focused on working together and problem solving. There is a natural push-pull between providers and payers but it can and should be a positive conversation because we all have the same goals of supporting the well-being of Minnesotans. Lucas Nesse, JD, President & CEO for the Minnesota Council of Health Plans. Since 2019, Mr. Nesse has guided the Council’s members toward consensus and is the face and voice of Minnesota’s nonprofit health insurance companies. He works with all of the member health plans and stakeholders to pursue high-quality and affordable health services for Minnesotans. Prior to assuming this role at the Council, Lucas was the Health Policy and Grassroots Director for the Minnesota Business Partnership, a large employer membership organization. He served previously for nine years in various roles at the Minnesota Senate. He’s also on the board of Minnesota Community Measurement.

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MINNESOTA PHYSICIAN MARCH 2021

3Ransomware in the Age of COVID-19 from cover destroyed UVM Health Network’s computer infrastructure on which encrypted data resided and put both patients and staff at risk.

As more workers become remote and health organizations continue to make the shift to be more connected technologically due to the COVID19 pandemic, the risk of ransomware attacks, as well as other forms of cyberattacks, has grown. This can be corroborated by examining the ransomware claims experience of Coverys insureds. When isolating data from the most recent fully developed underwriting year (2018), Coverys’ ransomware claims increased over 66% relative to the average of the previous four underwriting years, which is a notable jump.

The effect of the attack spread like pestilence throughout the organization. According to the Vermont Digger, UVM furloughed or reassigned about 300 employees who could no longer perform their jobs, services were postponed or cancelled due to the systems being offline, and the health system experienced a loss of The effect of the attack approximately $1.5 million per day due to disrupted spread like pestilence revenue and the resulting expenses of repairing the throughout the organization. organization’s infrastructure. Due to severity of the attack, HealthITSecurity reported that the state’s governor eventually deployed the Army National Guard’s Cyber Response Team to UVM to assist with recovery efforts. But this pestilence is not from nature – it’s man-made. Ransomware is a type of malware. It infects a computer or computer system and encrypts the files contained within. Then the ransomware delivers a dreaded message: pay a fee to retrieve the files or lose them forever. Some organizations agree to pay the ransom. However, there are no guarantees that this strategy will work. The cybercriminals may demand more money, launch another attack, or refuse to release the files despite payment.

In an April 2020 advisory released by the New Jersey Cybersecurity & Communications Integration Cell, a rising concern of COVID19-related cyberattacks and phishing scams have been specifically targeting the healthcare sector, which is more open to attack due to both the preoccupation with treating COVID-19 cases and following stringent protocol, as well as the everexpanding use of technology to keep healthcare organizations connected in the new age of telehealth.

Devastating effects In addition to data being locked or needing to pay a ransom, business owners could also experience a data breach due to ransomware. Ransomware is a significant reason for the number of data breaches trending upward in recent years. According to HIPAA Journal, businesses have experienced more data breaches in 2020 than any other year before. As the 2020 attack on UVM demonstrates, when a healthcare organization loses its data, the outcome can be devastating. And although all industries and organizations experience a punch from a ransomware attack, such attacks can cause life-threatening injury in a healthcare setting. For example, HealthITSecurity reported that another 2020 ransomware attack on a large U.S. healthcare system resulted in rerouted ambulances, delayed radiation and treatment for cancer patients, medical records that were inaccessible and even permanently lost, and hundreds of furloughed staff. But how can you fight an unseen, growing monster? Like the vaccine developed for COVID-19, the answer lies in developing a plan and taking action to prevent an attack before it has the chance to spread – and in having a safety net ready in the event of infection.

Preventing the spread To protect a healthcare organization’s employees, patients, and data, a multifaceted defense system is required. The typical initial infection is carried through a phishing email containing a link or attachment. Other infection opportunities include users inadvertently installing malware from the internet or from USB drives, and exploiting remote access using stolen or hacked credentials. To defend against the initial phishing infection, there are a few steps an organization can take: • Provide security awareness training to educate users not to click on links or open attachments from suspicious senders and without carefully inspecting emails for signs of phishing.

MARCH 2021 MINNESOTA PHYSICIAN

• Provide for phishing and spam filtering at the mail gateway. • Don’t install/run programs unless they’re from a reputable source. • Restrict the ability of end-users to install software themselves or only allow installation from whitelisted sources. • Only allow the use of trusted USB drives and don’t allow execution from USB drives. • Implement endpoint detection and response products to stop malicious code from executing. • Require strong, unique passwords and multifactor authentication.

If you have been attacked

which demonstrates the need for a solid contingency strategy in the event of a cyberattack. Therefore, it is equally important to be properly insured. Just as healthcare organizations have a written plan for responding to potential natural disasters, they should also have a written plan for responding to potential data breaches. Because in the age of technology and remote work, the question isn’t if, but when an attack will occur. In the event of a breach, both your organization and your board could face lawsuits. There may be some overlap between Directors & Officers (D&O) insurance, general liability, and cyber policies, but one should not assume that one policy type will provide all the coverage needed if an attack occurs. Check D&O and general liability policies to see whether they cover cyber events, as well as cyber policies to see whether they cover board members within the Definition of Insured. Consult with your organization’s insurance broker to assess whether your insurance coverages meet your organization’s needs.

As more workers become remote...ransomware attacks, as well as other forms of cyberattacks, has grown.

Once infected, oftentimes the initial malware will reach out to a command and control (C2) server in order to download additional malware or to open a backdoor allowing the attacker access to the system. To defend your systems against this infiltration, consider: • Domain Name System filtering/protection. • Next-generation firewalls used to block unauthorized egress traffic. Once past initial defenses, malware will use application vulnerabilities to execute code. The code will run under the context of the logged-in user, or the attacker will try to elevate privileges. Therefore, consider the following defense strategies:

Matthew C. Bertke, CPA, MBA is the Product Development Manager for Coverys a nationally recognized professional liability insurer and leader in addressing the challenges of health care delivery.

• Reducing access privileges so users have the minimum access that they need in order to do their job. • Regular patching of operating systems and applications, including web browsers. • Hardening of endpoint systems and the use of endpoint detection and response products to stop malicious code from executing and privilege execution. If the malware is able to execute and encrypt data, organizations must identify what data was affected, whether it was exfiltrated from the network and whether it can be recovered. The following tactics can be used as a data defense: • Encryption. • Audit logs. • Regular backups and testing of those backups.

Be Prepared These defense strategies can be used to fortify an organization, but even the safest of healthcare organizations are at risk of a stealthy attack during day-to-day activities. Data will be less secure at times to address the everyday aspects of sharing data with business partners, patients, employees, and others. These standard business needs create the weak points that hackers are eager to exploit. While prevention is the smartest strategy, it is not 100% effective. When isolating data from the most recent fully developed underwriting year (2018), Coverys’ Cyber Liability and Protection Plus incurred losses increased over 110% relative to the previous four-year average – a number

MINNESOTA PHYSICIAN MARCH 2021

3Stark Law and Anti-Kickback Statute Updates from cover

Looking At The changes

“unnecessary obstacles” to coordinated care. Some of the primary new changes to the Stark Law and AKS are intended to allow greater flexibility in structuring payments to physicians based on value based care models. The level of flexibility in the payments generally depends on the degree of financial risk involved in the arrangements, with greater flexibility being granted in arrangements where the provider assumes greater financial risk. The exact framework is beyond the scope of this article, but parties structuring compensation models should know that there is greater flexibility to pay physicians that are involved in value based care programs than there previously was.

The Stark Law changes are generally intended to reduce the burden on providers and also reduce technical violations and the backlog of selfdisclosures that CMS has been working through since the enactment of the self-disclosure referral protocol back in 2010. For those not very familiar with the Stark Law, at a high level it prohibits referrals of certain designated health services (DHS) from physicians to providers that the physician has a financial arrangement with, unless an exception exists. The challenge with the Stark Law is that intent is irrelevant in determining whether there has been a violation and in many cases, well-meaning physicians can end up violating the law and incurring extremely high financial penalties. Here are some examples of the recent fine-tuning.

In addition to greater flexibility in compensation arrangements, there is more flexibility surrounding patient incentives. Whereas previously, many patient incentives would have been prohibited as inducements, the new laws allow incentives if they further a value-based purpose for a specified patient population. The incentives allow provision of in-kind, preventative items, goods, or services, such as health related technology, patient health-related monitoring tools and services, or supports and services designed to identify and address a patient’s social determinants of health. For example, movie tickets as a reward for completing a therapy regimen will not be allowed, but onsite childcare services while a parent receives treatment will be allowed. Cash and cash equivalents (e.g. Visa gift cards) are prohibited, however vouchers and gift cards for a specific purpose are allowed (e.g. voucher for a free heart rate monitor).

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a. Group Practice Change While many of the Stark Law changes were intended to reduce provider burden, the clarification to the rules of allocating DHS profits across multi-disciplinary provider groups may require these groups to restructure their profit distribution methodologies. Fortunately these rules will not take effect until January 1, 2022, so that gives groups some time to plan. As some context, the Stark Law generally requires that profit distribution methodology among physician groups not take into account referrals of DHS, but there is an exception that allows compensation to be structured differently among subgroups of a physician group that contain at least 5 members. Some provider groups interpreted this exception to allow these subgroups to be paid according to DHS service line (cardiology receives lab profits; radiology receives imaging; etc…). CMS clarified that this was not the intent behind the allowance of subgroups and that instead all DHS service line profits must be combined prior to the profit distribution across subgroups. b. Commercially Reasonabl Change The Stark Law requires that compensation be commercially reasonable and the definition of what qualifies as “commercially reasonable” has been an issue that providers have struggled with over the years. One example is that health systems often suffer losses on their primary care service lines but they still have to hire physicians to fill those roles. Is the arrangement commercially reasonable even if the clinic is projected to run at a loss? Most parties to commercial transactions will not enter into it if they know they will lose money, however there are exceptions. Specifically, a lack of physicians in a particular specialty in a geographic area may justify higher compensation payments because of a health system’s need to have providers with that expertise. CMS realized this situation and clarified that arrangements do not necessarily need to be profitable in order to be commercially reasonable. c. Isolated Financial Transaction The clarification that CMS made with respect to the isolated financial transactions exception doesn’t present new opportunities for physicians but rather clarifies the application to help prevent the continuation of overly broad interpretations. Through the self-referral disclosure protocol process, CMS noticed that providers would attempt to remedy ongoing violations by making a single payment and then claim that the payment was an “isolated financial transaction”. CMS reasoned that if this interpretation was correct, that it could ultimately be used to retroactively correct any Stark Law violation and obviate the need for any other exceptions. CMS clarified that the intent of this exception is to cover one-time events, (e.g. the sale of physician practices) or events occurring over a short timeframe (e.g. a weekend of call coverage).

Services Safe Harbor previously required compensation to be set in advance d. Period of Disallowance The Period of Disallowance refers to the time and this was interpreted to require that the total aggregate compensation be period that any referrals of DHS are prohibited and it is used to calcucalculated at the time of entering into the contract. That basically requires late the financial penalties for noncompliance with the Stark Law. In an that any contract be structured as a fixed fee which creates problems when attempt to draw a clear line, CMS provided guidance for the calculation the arrangement is more appropriate for an hourly of the Period of Disallowance which ultimately fee or per-unit charge. The revisions to the Personal resulted in a overly rigid formula. CMS was Services Safe Harbor now change this requirement seeing voluntary disclosures involving technical so that only the compensation methodology needs violations of the Stark Law that would ultimately to be determined in advance. This is a significant end up with penalties of several million dollars. change that will allow many more arrangements In an attempt to curb this, CMS provided guidThere is more flexibility to qualify for the safe harbor. ance on how a Period of Disallowance can be surrounding patient incentives. eliminated if a Stark Law violation resulting from In summary, the AKS and Stark Law changes an administrative error is resolved within 90 days might offer providers new opportunities. This of expiration of the arrangement. article provides a high level summary of some of e. Limited Remuneration The new limited remuneration exception to the Stark Law is probably going to have the most significant impact of all of the Stark Law changes as it pertains to preventing technical violations that pose little risk of fraud or abuse. This exception is intended to apply to arrangements involving less than $5,000 annually that fail to qualify for other Stark Law exceptions. Now, there are still some conditions to qualify for this exception so providers should not think that this exception will allow DHS entities to write a $5,000 check to physicians. Notwithstanding these conditions, if an arrangement wasn’t premised on referrals and is within the $5,000 limit, there is a good chance that this exception could apply. When taking this exception into account with the guidance provided in relation to the Period of Disallowance, it is clear that CMS intends to reduce Stark Law violations resulting from technical issues that pose little risk of fraud or abuse.

these opportunities. Physicians should consult with experienced health law counsel prior to structuring arrangements that might implicate either law. Antonio “Tony” Fricano, JD, is a health care attorney at Lathrop GPM and has extensive experience advising physicians, health systems, and other health care organizations. Prior to starting with Lathrop GPM Tony was an in-house attorney at the largest health system in Illinois.

Cybersecurity Safe Harbor/ Stark Exception One of the additional opportunities for providers is the new allowance for donations of cybersecurity (generally from health systems to provider groups) that were added to the Stark Law and AKS. This allowance is similar to the EHR exception and safe harbor introduced back in August of 2006. Of course there are protections intended to prevent abuse, but on the whole this is a win for providers. It should be noted that the exception and safe harbor prohibit selection of donation recipients based upon criteria that takes volume of referrals into account and that providers cannot require a donation as a condition of doing business with another provider. In other words a hospital cannot determine donation recipients based upon the amount of referrals it receives and physician groups cannot demand a donation as a condition to supplying referrals.

AKS Personal Services Changes AKS has broader application than the Stark Law and should be looked at in connection with any agreement involving physicians. Because AKS is an intent based statute, the technical violations that existed under the Stark Law are less likely to occur under AKS. Still, providers that are seeking certainty that their arrangement does not violate AKS will want to structure their arrangements to fall within a safe harbor. There are more than twenty safe harbors, and one of the more significant changes we saw from OIG with respect to AKS is that the requirements of the Personal Services Safe Harbor have been changed to allow wider application. Specifically, the Personal

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BEHAVIORAL HEALTH

Facing a Psychiatric Bed Crisis When demand exceeds supply TODD ARCHBOLD, LSW, MBA

s the world is resetting in the hopeful light of recovery from the pandemic, the fragile state of the mental health of our populations is increasingly apparent. We’ve endured the devastation suffered from the loss of life from COVID-19, economic tail spinning, political divide, and the fatigue of quarantine. While the situation is improving by the day, its impact on mental health will be lasting. There is a mental health crisis in our communities, and among health care workers. A new paradigm with more flexible care and equalizing disparities must arise and it will take a united and concerted effort to fulfill.

The state of psychiatric healthcare in Minnesota There are over 1 million people in Minnesota experiencing symptoms of a mental illness today, which translates to almost one out of every 5 of us. The most common conditions are anxiety and depression, both of which have been greatly exacerbated by the impact of the pandemic. It is estimated that less than half of these individuals will ever seek help for their symptoms. Nearly 285,000 Minnesotan’s are currently struggling with a serious mental illness, resulting in substantial functional impairment and interference with

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major life activities (such as school or work). Our current “mental health system” is a collage of state operated, non-profit, and private providers offering often high-quality, but fragmented levels of care. Minnesota is home to some nationally recognized providers of health care ranging from Mayo Clinic and Allina Health to specialized behavioral health providers like Hazelden Betty Ford, PrairieCare, and The Emily Program. Collective efforts to improve population mental health in the past few decades have been largely focused on effective community-based services such as targeted case management, day treatment, school-linked services and mobile response. Inpatient psychiatric bed capacity across the nation has shrunk by over 90% since the 1950s through the movement of “deinstitutionalization”, moving many individuals with severe mental illnesses to emergency rooms, jails or the streets. There are nearly three times more individuals with a serious mental illness in jail or prison, than in treatment facilities. ERs have become the most common entry point for a psychiatric crisis, and on average it takes 3.5 days for a hospital bed to become available, and often much longer for children and adolescents. There are currently 202 psychiatric hospital beds for youth and 590 adult beds in Minnesota, not including state run facilities. These meager capacities are reduced even further by a shortage of staff. Minnesota ranks 50 out of all states on having the fewest number of psychiatric beds per capita (3.5 beds per 100,000). The recommendation by health policy experts is 40-60 mental health beds for every 100,000. Most psychiatric units are at max capacity, most of the time – especially child and adolescent units. Minnesota has a moratorium on hospital beds, which requires an arduous and costly review process that ultimately requires legislative approval to add new licensed beds. This has prevented some systems from responding to this crisis. The state recently adopted the national model for Psychiatric Residential Treatment Facilities (PRTF), yet most commercial insurance companies have excluded PRTF care in contracts, creating access barriers and endless stress for patients and families. The availability of psychiatric hospital beds in Minnesota is so limited, that the Department of Human Services and Minnesota Hospital Association created an online tool to help providers find available psychiatric beds across the state in real-time. Most often psychiatric beds are classified simply by age range; however, the term “psychiatric bed” is a misnomer as the care required for patients in crisis varies greatly. A psychiatric episode of care may vary from short-term stabilization, to several weeks of evaluation and complex medical support. Regardless, many days the bed finder tool will show that there are zero beds available. No other area of acute health care requires a bed finder – what does this tell us about the way we are responding to psychiatric needs in the state?

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MARCH 2021 MINNESOTA PHYSICIAN

The main barriers we face in maintaining psychiatric inpatient units are not hard to understand. Why do we see ongoing expansion of birthing units, cardiology, and orthopedics, but not psychiatry? The data clearly suggests the need for psychiatric services, and the mortality rates of severe

mental illnesses easily outweigh the need for expansion in every other area of medicine – so why is there no investment in psychiatry?

and will be at high-risk of relapse and recurrence the rest of his life. The hospital and the health plans also know what to expect in this case – and neither like it.

In the case of the appendicitis, a highly coordinated surgical team will perform the procedure in about an hour, and the patient will recover over the course of 2-3 weeks. The hospital could perform upwards of 180 appendectomies per year with the same care team, same OR, and a single hospital Consider this: room. In the case of the substance abuse and A 23-year-old male presents to an emergency psychosis, very few specialized care teams exist, and Minnesota ranks 50 out of all room with stabbing pain in the abdomen. there is not single hospital procedure to remedy the states on having the fewest The patient is quickly diagnosed with acute number of psychiatric condition. The over-medicalization of psychiatric appendicitis through imaging and routine labs. beds per capita. conditions overshadows emotional distress. The Physicians quickly determine evidenced-based initial phases of treatment may require a hospital bed care path, and the condition is aptly treated with for 2-3 weeks, and plethora of mental health staff an appendectomy and will discharge from the monitoring the patient 24/7. The reimbursement for hospital in 1-2 days. Both the hospital staff and the an entire week of observation may be similar to the insurance company know what their investment single appendectomy procedure that took place in just a portion of a single day. will be, and the likely outcome as benchmarked by hundreds of thousands There is a systemic ignorance of lack of parity in mental health care, and of similar cases. many fail to recognize this injustice. It is commonly known that reimbursement The same patient a year later, now 24-years old, presents to an emergency for mental health services is at least 20% less than the rest of health care. room addicted to painkillers and is in a state of psychosis. There are no definitive This leads to lower staff wages and a lack of investment in infrastructure and labs or tests to diagnose the frightening condition, the medical history is complex, innovation. This outright disparity in payments stifles growth and has the and there are likely no psychiatrists available. Emergency room staff doesn’t know state of mental health care services at least 20 years behind the advancements what to do. This patient will not be compliant with psychiatric treatment and will likely need several weeks of intense stabilization, many months of treatment, Most large hospital systems across the country report that it costs more to provide inpatient psychiatric services than is covered by health plans. The patient care pathways are also much harder to predict.

Facing a Psychiatric Bed Crisis to page 164

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MINNESOTA PHYSICIAN MARCH 2021

3Facing a Psychiatric Bed Crisis from page 15

In the instance of psychiatric crisis, nearly 70% of patients in Minnesota will require a transfer from an emergency room that lacks capacity, to another throughout the rest of health care. The annual investment in mental health facility that may be hundreds of miles away. These transfers are costly and can create additional trauma. Psychiatric units within large health systems research is an abysmal 4% of total health research funding, despite the fact can become disenfranchised as they often compete that some studies have shown the ongoing costs for resources and funding with more profitable to treat behavioral health conditions contribute to departments. In the current climate, it remains the nearly 45% of total health care spending. At the onus of the few health systems that already offer end of 2020, a monumental lawsuit found one of psychiatric care to be the catalyst for change. Those the nation’s most profitable insurance companies It costs more to provide inpatient who are already invested in psychiatric health care was intentionally and methodically denying psychiatric services than is are bearing the weight of change, absorbing the coverage for psychiatric services. The investigation covered by health plans. pressure from other hospital systems to care for their revealed denials for care led to kids right here in sick patients in crisis. This can oftentimes lead to Minnesota dying as a result of an identified, but tension between hospital staff who are simply try to untreated mental illness. help their patients. Health plans and employers have astutely How we transform psychiatric healthcare developed wellness programs designed to combat We have opportunities to improve our system and become more solutionchronic health conditions such as obesity, diabetes, cardiovascular disease and oriented. We must address staffing and cost issues while including a much more. Members are incentivized to eat well, track daily steps, and are even given deeper investment into prevention and early identification. We must allowances for in-home gym equipment. These plans work remarkably well consider things such as: and have many overlapping benefits for mental health. However, individuals with serious mental illnesses often lack the resources, information or employerconnected health plan to engage and benefit from these types of plans. There appears to be little, if any, investment in engaging in these individuals.

• Integrated mental health services throughout all areas of medicine. Imagine psychologists and counselors prevalent in every trauma unit, birthing center, pediatric clinic, and GI clinic.

Standalone behavioral health facilities have proven successful but lack true health system integration and can have innate barriers to accessing services.

• More therapists in schools, and tools to screen for depression and anxiety in students – along with deeper education in wellness and resiliency.

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MARCH 2021 MINNESOTA PHYSICIAN

telehealth capabilities for quick access to specialists. These approaches will also reduce the tendency to medicalize complex psychological problems and distress.

• Streamlined access to mental health providers to truly build a continuum-of-care, not fragmented and siloed specialists. Regional disparities will always exist, and telehealth is our best tool to even the playing field. The nation needs more training programs for psychiatrists, and we need to create jobs in the mental health field that pay better. Medical students early in their career are easily swayed towards much more lucrative careers in medicine such as surgery, interventional radiology, cardiology, urology, and others. We can also benefit from creating more opportunities for innovation, ranging from research to technology. Mental health care is lagging behind in this area, and we need to invest in the field to make it more exciting for workers and effective for patients. We also need to develop a more diverse workforce that can represent and tailor to the cultural needs of our patients. While the prevalence of psychiatric conditions across racial and ethnic groups is similar, studies show that minority groups are 50% less likely to access care because of these differences. We need to invest in a fully integrated and balanced continuum of mental health services that includes telehealth. In order to effectively reduce the demand, we need to focus more resources on prevention and early identification in primary care, schools, and even among employers. The goal is to prevent crisis and reduce hospitalizations. All health care systems and providers have a responsibility to respond to mental health needs of patients. This requires more training in mental health, including identification of symptoms, crisis management, and providing basic care to those experiencing symptoms. Hospitals can benefit from specialized patient care spaces that decrease stimulation to provide a calming atmosphere, mitigate ligature risks, and have

Small psychiatric units embedded within large health systems can be tough to manage as they lack the capacity for diverse psychiatric specialization required for individual needs, and suffer from a lack of economies of scale. They can be financially subject to pro rata share of system costs and resources that are typically not required for psychiatric care (i.e. imaging, labs, ORs). In contrast, large standalone systems can struggle due to a lack of general health integration and access to necessary medical care resources. Rather, an integrated health system or collaborative partnerships that balances adequate psychiatric capacity and diverse mental health resources within a broader health system has countless benefits. Opportunities to share staff and offer two-way consultation within an integrated system lead to increased staff engagement and retention, and ultimately better patient experiences. This will reduce wait times and the inevitable need for stressful and costly transfer between facilities. The case for why we need to transform psychiatric healthcare is simple – it requires a transformation. Our current systems are not sustainable or nearly as effective as they could be. Thousands of individuals suffer from mental illness and don’t have access to the care they need. This increases the morbidity and mortality of chronic health conditions, and this will not improve on its own. We must be the agents for change. Todd Archbold, LSW, MBA, is a licensed social worker and the Chief Executive Officer at PrairieCare.

V Alzheimer’s is now an approved condition V

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MARCH 2021 MINNESOTA PHYSICIAN

SOCIAL DETERMINANTS OF HEALTH

E-referral Solutions Screening and connecting patients to community services REID HAASE, MA

he American Journal of Preventive Medicine indicates that 80%90% of a person’s overall health is determined by socioeconomic factors and environmental factors (where we live, learn, work, and play). The balance of 10%-20% is attributed to care provided in hospitals, clinics, and other traditional health care facilities.

For many people, the pandemic and racial injustice have compromised their ability to satisfy the foundational needs in Maslow’s pyramid and, additionally, ensure that medical treatment and access either continues to be available or is made available. The problems are daunting when we look at the needs that have escalated in the social domains as organized by the Department of Health and Human (DHHS). These domains include economic stability; education access and quality; neighborhood and built environment; social and community context; and health care access and quality. To address these concerns, emerging and actionable solutions are helping create a path toward connection and improvement. Health care does not typically factor in upstream structural social conditions that hinder optimal health, but we can utilize enhanced electronic approaches to connect patients

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with organizations in our communities to address social needs precipitated by the upstream structure. Technology platforms known as e-referral solutions have been available for years and are gaining traction due to the growing global, national, and local health disparities and health equity challenges. A handful of established and emerging vendors are automating the complex landscape of assembling a catalog of social resources and constructing automated processes of screening and connecting patients to these resources. The technology needs to be accompanied by designing clinic-to-community workflows, as well as educating staff and clinicians about the importance and impact of the 80% of determinants on patient health.

Addressing The Process Creating links in the chain between health care and community can improve multiple factors. We may not know which patients are in need or which supportive social services exist to serve patients in a community. Current processes from screening through referral may be nonexistent or manual and inconsistent (e.g., a recommendation to visit an agency, an address, a phone number, or a person to talk to which are jotted down and handed to the patient on a piece of paper). At best, the current referral processes are complex, relying on social workers, nurses, and sometimes doctors who have varying levels of knowledge about the services that exist in their community (also discounting the need to know about qualifications needed to utilize the services, languages spoken, hours of service, etc.). Unfortunately, the referring health care professional invariably has no idea whether the patient followed through on the referral or whether services were delivered. These are the links e-referral vendors create on behalf of patients. The ills of the social referral process are analogous to breakdowns in medication adherence where there may be no feedback on whether prescribed medications have been picked up from the pharmacy and taken as prescribed. Minnesota patients are starting to benefit from e-referral vendors applications that enable new workflows to be incorporated into daily encounters with patients which start with a detailed screening/risk identification step. At a basic level, e-referral solutions enable health care and community-based organizations to identify individuals at risk, screen for social needs in a broad set of social categories, and electronically refer patients and community members directly to community-based organizations (CBOs)/agencies that can provide assistance beyond what the health care system is able to or designed to deliver from a social services perspective. An added key benefit is the automated solutions offer a “closed loop” feedback mechanism that a CBO can populate and indicate how and whether the referral was addressed. This critical piece of information is a starting point for a referring organization to understand and analyze the impact and benefit for their patients based on aggregated or individual referral data.

Using the Tools The first step is to identify which patients or segments of patient populations are at risk. It is helpful to consider which segments within a defined

ongoing missions. If health care doesn’t partner with the community and population may be at risk and narrow the focus of who is likely to benefit from CBOs to discuss the workflows, expected volumes of referrals and payment screening for needs in the social domains. Much like the PHQ-2 or PHQ-9 mechanisms, the CBOs can quickly become overwhelmed. We also cannot for depression screening, a brief set of questions can lead to further questions assume CBOs will have the bandwidth and ability to have the needed staff to determine which social needs exist. There are also data analytics that can to receive, acknowledge, and send back data to be done by third-party vendors to help narrow the the referring organization without some level of wider net of screening. This may involve sorting by support and training. CBOs frequently operate ZIP code or even block or street level to help narrow on limited budgets, braided grant funding, and the screening to patients with a high probability of may have high staff turnover, all of which must social needs (a positive SDOH screening). E-referral be factored into efforts to implement referral vendors do not solve the questions of determining Minnesota patients are starting to workflows and utilize any vendor application. which patients or groups of patients to screen. benefit from e-referral vendors. Any effort to implement an e-referral system and Once individuals who may be at risk are clinic to community workflows must engage the identified, the next step is employing a validated community partners at the outset. Their voices screening tool. There are several such as the and concerns need to be included in the planning, Protocol for Responding to and Assessing Patients’ implementation, and ongoing operations stages in Assets, Risks, and Experiences (PRAPARE) which the spirit of “nothing for us without us.” was developed the National Association of Community Health Centers; the As we recognize and account for additional utilization placed on community Accountable Health Communities (AHC) Health-Related Social Needs service agencies, we also need to contemplate and design workflows that do not (HRSN) screening tool developed by the Center for Medicaid and Medicare create unmanageable burden — a key reason to engage CBOs early. We need to Services; an internally developed set of patient risk screening questions; or be clear about who we are screening, ensuring we don’t cast the screening net too an EMR vendor created set of questions. The e-referral vendors are broadly widely and create unnecessary work on the health care side of the partnership. able to incorporate responses from any of these screening tools. From an access and equity lens, we know that many high-risk populations Some organizations and communities may have identified priority needs are not native English speakers and may need special assistance. Screening through a community health needs assessment (CHNA) or aggregated data from individual screening results, but are challenged by not having CBOs/ E-referral Solutions to page 344 agencies that provide corresponding services for each social domain in the screening. Broad patient population screening has the benefit of collecting data that can be used to better support structural needs changes and can be used for policy work at many levels. An adverse effect that must be considered when deciding on the breadth of questions and whom to screen is creating expectations for services or solutions that may not exist within the community.

SUNFLOWER SPREAD

Taking Action Steps Once the screening steps have been completed, referring is where the strength of the e-referral solutions lies. All e-referral vendors rely on a database of local CBOs they build (using different data aggregation and community outreach techniques) that is maintained on a regular basis and serves as a “phone book.” This enables immediate matching from the needs-based screening to the appropriate services, whether based on location, hours, languages spoken, or other dimensions. The “needs to services” matching algorithm is typically highly customizable and eliminates the uncertainty of which services are appropriate for a patient, while eliminating the need to rely on roles or individuals within an organization. An electronic social needs referral is indeed akin to a prescription. It is simply a social services prescription that can direct patients to the most appropriate services based on list of parameters that each vendor makes available. The agencies that receive these referrals (and are participating in the vendor’s network of CBOs) can close the loop and send confirmation back to the referring source (whether health care or another source such as another CBOs, school, etc.). Receiving this information helps determine how effective the workflow has been and whether the services available are meeting the social needs identified. It is important to keep in mind that even in the best of times, many CBOs are constrained in their ability to deliver services and support their

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MINNESOTA PHYSICIAN MARCH 2021

ADMINISTRATION

Clinical Service Lines A training ground for the emerging physician leader DANIEL K. ZISMER. PH.D.

he demand for trained and experienced physician leaders is increasing at an accelerating rate domestically and internationally, and opportunities for physician leaders are no longer isolated to the C-Suite of health care organizations, or larger medical groups. Likewise, these job openings are no longer reserved for the physicians who may have matured into the twilight years of their career, or physicians who must abandon clinical care in favor of full-time medical administration. Experience with the Health Care Administration Program, University of Minnesota identified growing interest from younger, practicing physicians in developing competencies in a parallel career; healthcare management. By the third year of the newly launched Executive MHA program, it was clear that physicians at mid-career and less, whether domestic or international, came to the program with unapologetic enthusiasm for their desire, as one young physician put it “to develop a different part of my brain”. Another, a young interventional radiologist, by his mid thirties, had already decided that he “did not want to go through the rest of his career wearing a lead apron”, and a third interviewed for admission to the program had stated that “I want to provide myself options as my medical career unfolds”.

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As physicians consider a career in organizational leadership there are typically two questions that loom large. Both are addressed here. The first is “will I need to eventually give up the practice of medicine to succeed?”, the second “is there a reasonable, more measured way to get started on the path?” The answer to the first is easy. No! There are a number of leaders who effectively navigate roles as clinicians and as leaders in health systems and medical practices, while some do decide to hang up their stethoscopes in favor of an alternative way to contribute to patient care, and healthcare delivery more broadly. The second question presents the centerpiece of this article: “is there a manageable way to get started on the path of becoming a physician leader?” The answer to this question is represented by a fast expanding opportunity for physicians who wish to get their feet wet with a meaningful role in leadership without jumping into the deep end of the pool. That opportunity is serving as the physician member of a “leadership dyad” in charge of a clinical service line within a health system or medical clinic. In a chapter written for Mechanick and Kushner’s 2020 book titled “Creating a Lifestyle Medicine Center” (Zismer, D.K.) a clinical service line is described as “a grouping of defined clinical services and programs dedicated to an identified constellation of related diagnoses, and clinical conditions, designed and dedicated to produce superior course of care, over time, based upon evidence-based, best practices for defined clinical populations”. Clinical service lines are often, but not exclusively, dedicated to the management of chronic diseases and conditions. The clinical service line “leadership dyad” pairs a practicing physician leader with a trained administrative services partner to oversee the design, leadership and management of the clinical service line. The physician partner in the dyad has a defined, part-time job. The position is typically responsible for providing the clinical guidance to how, and how well, the clinical service line functions and performs its obligations to patients served, including how providers work as teams to enhance clinical outcomes, and how clinical and staff resources are applied to create optimal outcomes. To be clear, the leadership dyad is not two people doing the same job. The physician and administrative dyad partners bring unique skill sets and competencies to the leadership of the service line.

A Model for Shared Leadership But are clinical service lines a real and sustainable strategy worthy of redirection of a physician’ career path? In a survey of 47 health systems conducted by Wegmiller and Zismer, 85% of systems in the sample stated they had already launched, or expected to launch one or more clinical services as principal components of an overall organizational strategic plan. Most health systems in Minnesota have long since decided to compete based upon what are easily identified as clinical service lines including; “heart and vascular centers”, “sports medicine”, “mother and baby hospitals”, “pain management centers”, “behavioral health programs”, “lifestyle and wellness centers” and “diabetes management programs” to name a few. So if starting on the path of physician leadership can begin as member of clinical service line dyad, what does the emerging physician, with little Clinical Service Lines to page 224

MARCH 2021 MINNESOTA PHYSICIAN

Peter Schultz, MD, MPH Medical Director Nura Pain Clinics R. Scott Stayner, MD, PhD Medical Director Nura Surgery Centers David Schultz, MD Chief Executive Officer Nura Pain Clinics

1. Chronic pain doesn’t take holidays. Although the COVID-19 pandemic has captured the headlines, chronic pain does not relent. According to the CDC, high-impact chronic pain (pain that interferes with work or life most days or every day) affects approximately 20 million U.S. adults.

2. Opioids are a problem. They can also be part of the solution. According to the CDC, opioid overdose is now the leading cause of injury-related death in the United States. Yet opioids have a rightful place in treating chronic pain, as some patients achieve life-changing improvement with minimal side effects on long-term opioids. Even at high dosage levels, opioids do not harm the body’s organs, unlike NSAIDS and acetaminophen. And thanks to the micro-dosing capability off ered by implanted spinal drug pumps, many of the most challenging cases can be treated effectively without risk of addiction.

Our thoughts on chronic pain…

3. There is no silver bullet. One of the challenges in treating chronic pain is the patient’s sometimes-overwhelming desire for a silver bullet, a “cure” or a magic button to turn oﬀ their pain. While that desire is understandable, in complex chronic pain there is rarely a single perfect answer. At Nura, we’ve found that a comprehensive approach which addresses the physical and psychosocial components of chronic pain is the best solution. So in addition to earning national recognition for leadership in implantable pain technology, we oﬀer behavioral counseling, physical therapy and opioid management, all designed to help the most challenging pain patients.

If you have a patient struggling with chronic pain and you’d like to discuss the case, please call our Provider Hotline at 763-537-1000. If the situation is urgent, we will do our very best to see your patient the same or next day.

MINNESOTA PHYSICIAN MARCH 2021

3Clinical Service Lines from page 20

• Identifications of practice style markers that may serve as useful sources of clinical service line operating productivity performance metrics; e.g., types of provider work relative value units, types of diagnostics applied, care model team configurations, interactions with related patient care providers, and use of pharmaceuticals.

or no real leadership or management experience have to offer? The answer hides in plain sight; it is what they already know, or know how to know, as an experienced clinician. The value of the dyad, and the clinical service team, is best described by the old bromide, “two heads are better than one”. With dyad leadership, the physician member of the team brings the clinical experience and understandings. This includes, but is not limited The leadership dyad is not two to, knowledge of the following: people doing the same job. • Expected clinical outcomes. • Evidence-based standards of practice brought about by an integrated and coordinated team care.

• Expected rates of hospitalizations and re-hospitalizations. • Identifications of the provider behaviors that are counterproductive to the mission, goals and objectives of the clinical service line, including how to identify them in related service line performance metrics. • The construction of useful, applied service line performance scorecards.

• How to understand variation of practice style and the effects on clinical outcomes and related resource use variation. • How various combinations of clinical program inputs (diagnostic and therapeutic services) can enhance or sub-optimize clinical efficacy, efficiency, and total cost of care performance. • How specific patient characteristics, and traits, may interact with care protocols to affect program adherence, clinical outcomes and value derived from established care models.

• Ongoing analyses of how the incentives created by provider compensation plans align (and misalign) with service line mission, goals and objectives. Pursuit of these goals provides for more than a sufficient part-time job for any physician member of a clinical service line leadership dyad. The physician leader in the dyad carries at least half of the responsibility for encouraging high-functioning team care. Virtually every clinical service line promises patients an integrated and coordinated experience. Those that succeed deliver on that promise.

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Physician Coaching Leadership Coaching Clinical Team Building

The leader interested in “moving up the leadership chain of command” in health systems, and in larger medical group practices, will need to develop advanced skills and competencies. Here the expectations of the physician leader expands, and more formal, graduate-level healthcare administration or “B-School” education and training may be required. But beware the trap, and trust this bit of advice. The trap is physicians who pursue graduate degree training in an attempt to compete with the seasoned, non-physician executive. Physicians can fall prey to the belief that “if I earn an MBA, I’ll know everything that every other MBA knows”. Translate that thinking to medicine. Does the new medschool grad know everything a physician with 20 years of experience knows? The answer is obvious. Physician leaders don’t need to compete with the non-physician executives. Remember, physician leaders have a special knowledge and experience foundation that can’t be replicated by non-physicians; it’s the knowledge of the practice of medicine! The other MBAs or MHAs in the room can’t bring that. Never try to play another person’s game. Too many physician leaders fail as leaders, or quit as leaders, because they tried to compete with the wrong “competitors”. Many-a-physician in the C-Suite has told me “I don’t even understand the language the non-physician executives are speaking. The best response is always, “turn the tables”. Step-up with what you know and what is always relevant; the effective “manufacturing” and delivery of the right patient care, at the right time. Your job is to bring the medical care and relevant patient care aspects of the service line business plan to the table. The successful physician leader learns to integrate the language of clinical care and the practice of medicine with service line business planning, management and performance evaluation. Clinical service

line strategies often fail because the practicalities of clinical practice were missing during the developmental stages of business planning and service line implementation.

• Clinician and staff behavior effects on the patient experience. • Understandings of how the clinical processes implicate other clinical care requirements of patient served; i.e., the integration of clinical care beyond the identified service line.

For the physician clinical service line leader who has designs on being the next CEO of the health system or medical group, • Organizational psychology and the effects on formal, graduate “business school” training may be culture and performance. required. If pursued, be mindful of the curriculum • The discipline of innovation and business practice. design provided. The curricular offerings need • Change management. to complement the role of a physician leader. A Physician leaders don’t need to portfolio of syllabi representing general business Completing the Circle compete with the non-physician courses can be useful, but may not be specifically executives. Now let’s return to the beginning. Almost relevant to the needs of a physician with leadership everything an emerging physician leader needs experience under their belt. When examining the to know about the “business of medicine” resides curriculum of a graduate level degree program, with the design, leadership and management of look for the opportunities to acquire skills and a single clinical service line. Every large health competencies in the areas of: system and complex medical group practice is composed of a combination • Organizational culture and its effects on clinical process and patient of clinical service lines. Even the complexity of the clinical enterprise that experience performance. is Mayo can be distilled to an aggregation and integration of multiple clinical service lines. There practicing physicians who are the next • How the right clinical processes will bear upon service line staffing generation of health system and medical group physician leaders have a composition, business operations and financial performance. practical path and training ground to test the waters of leadership in a way • Analyses of clinician practice style variation and the potential effects that doesn’t put their clinical career at risk. on service line productivity and operational and financial performance. • Continuous quality improvement. Clinical Service Lines to page 324

• Continuous process improvement.

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 MARCH 2021

TELEHEALTH

Digital Health Care A look at growing trends BY DR. ROBERT KANTOR, MD AND KRISTI HENDERSON

ith the COVID-19 pandemic creating necessary constraints on how, when and where people access health care, digital health resources have emerged as an important bridge helping keep health care professionals and their patients stay connected.

One recent analysis estimated by 2027 the digital health market will have grown by nearly 18% a year. This growth projectscts the potential benefit of digital health technology, including its ability to help facilitate more personalized conversations between patients and doctors based on near real-time data. As health care professionals look for ways to expand patient services and grow their practices, leveraging digital health technologies is likely to become increasingly important. What follows are strategies health care professionals might consider during COVID-19 and beyond.

Integrating Virtual Care The pandemic is creating a reliance on and awakening of the full potential of virtual care, opening a door to reinvent the model of care moving forward.

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The key is using digital heath tools to help care professionals reach, engage and build trust with patients in ways that cannot be accomplished with infrequent visits to a doctor’s office. Health care professionals can consider offering a hybrid model of both virtual and in-clinic services that can maximize the patient experience, increase quality, drive affordability and optimize clinic-space utilization. The use of virtual care resources has surged more than 10-fold compared to before COVID-19 emerged, with more than half of consumers stating that the pandemic has increased their willingness to try virtual care. For many patients, virtual care provides a more convenient way to help connect with care professionals about various health issues, ranging from routine care and urgent health concerns to ongoing chronic condition management, and specialty services. The potential benefits are much broader than improved convenience and access. Virtual care minimizes geographic disparities seen by the 60 million Americans living in rural areas, reduces transportation challenges that are cited as the third most common barrier to care, and can remove a hurdle that makes accessing care difficult for the 40% of Americans who have at least one disability. A digitally-enabled system can minimize these inequities by delivering the right care – at the right time – in any location and ultimately create a better patient experience. To help make that possible for their practices, health care professionals may want to evaluate offering these services through their own virtual care platform or contracting with a third-party vendor. Creating a virtual care checklist for staff members may also be helpful as this practical tool can support a smoother experience for both patients and staff. In addition, health professionals may want to take the CORE Telehealth Certificate program to ensure they are equipped with the knowledge they need to provide safe and high-quality care through telehealth. It’s also important to keep in mind that investing in virtual care capabilities can support a practice’s progression through the continuum of value-based care and encourage success in risk-based contracts with health plans. Virtual care tools are becoming increasingly important to close care gaps and improve Healthcare Effectiveness Data and Information Set (HEDIS) scores. By improving patient access to virtual care and through other digital tools like remote monitoring, it may improve health outcomes, better identify and manage chronic conditions, improve satisfaction, enhance connections and relationships and curb costs – all important outcomes in any value-based care program. It is important to note that health plans are now embracing – and reimbursing for – virtual care. Even after COVID19 declines, it will be important for medical practices to continue offering virtual care solutions to help meet patients’ needs and expectations, and to encourage success in risk-based contracts with health plans. Strides in technology have also made telepharmacy largely indistinguishable from traditional pharmacy. Telepharmacy can be offered through remote dispensing sites, which look and feel like a pharmacy. Prescriptions and patient counseling are overseen by a pharmacist remotely,

via HIPAA-compliant audio/visual technology. A benefit of telepharmacy is that it enables quality pharmacy services to be located in remote settings that otherwise could not support a full-service pharmacy. When quality pharmacy services are integrated into health care settings, research shows medication adherence rises and hospitalization and emergency services drop. Care professionals, particularly in rural or underserved communities, should consider evaluating how telepharmacy can help them better serve patients and expand their care team.

Consider Recommending Wearables

Discussing wearables and other emerging technologies with patients – and incorporating them into a holistic treatment regimen – may encourage them to take a more active and data-driven approach to preventing disease before it starts and treating chronic conditions, if needed.

Encourage Whole-Person Health

Leveraging digital health technologies is likely to become increasingly important.

Many Americans already rely on smartwatches and activity trackers to help monitor their daily movement and sleep patterns as well as help support their efforts to improve their well-being. With wearables now part of our day-to-day lives, some people are also becoming comfortable using them as a resource to promote wellness and help manage certain chronic conditions, including to use personal data to make more informed decisions about their care and daily habits. To that end, care professionals can recommend that patients check with their health plan for incentive-based well-being programs, which are offered by many employers and some Medicare Advantage plans. Some programs provide wearables to eligible participants at no additional cost, enabling them to earn financial incentives such as deducible credits by meeting certain daily activity targets. For people with type 2 diabetes, continuous glucose monitors (CGM) are another potential resource. By transmitting data about glucose levels to the patient’s smartphone or other digital device in near real-time, the patient and their care provider may be able to more easily identify relationships between eating, exercise and blood sugar that may be difficult to observe with only test strips and a glucose meter. Some health plans across the country are starting to provide CGMs at no additional cost to members as a digital therapeutic, helping to make this technology more affordable for patients. The growing use of CGMs is especially important amid the pandemic, as people with diabetes are at a greater risk of complications from COVID-19. Importantly, research shows people with existing diabetes whose blood sugar is well controlled may require fewer medical interventions and are more likely to recover from COVID-19. In the future, other types of wearables and patient monitoring initiatives may also make a difference in the management of chronic conditions, such as heart failure. By leveraging blood pressure cuffs, scales and pulse oximeters to measure blood-oxygen levels, pulse rate and perfusion index, care professionals may increasingly be able to identify potentially serious changes and more quickly intervene, which may help to avert complications and possible hospitalizations. Likewise, some physicians are starting to recommend “smart inhalers,” which use Bluetooth® technology and mobile apps to send near real-time data back to patients and health care professionals to help them monitor medication usage patterns. In fact, a recent Northwestern study in Pediatrics found that the use of sensor-based inhaler monitoring may help improve asthma symptom control and caregiver quality of life. Additionally, to help people with asthma, physicians can consider suggesting other connected devices to measure indoor air quality, offering near real-time feedback to help people reduce exposure to potential irritants.

While virtual care has emerged as increasingly important for medical care, technology is also changing how people access other types of services that may encourage whole-person health. When counseling patients, consider discussing these other types of virtual care resources:

Behavioral Health. With many people spending more time at home due to the COVID-19 pandemic and some experiencing the stress of job loss or illness, behavioral health issues may be more widespread. In fact, 53% of American adults reported that their mental health has been negatively impacted due to worry and stress related to COVID-19, contributing to difficulty sleeping, poor eating habits and increases in alcohol use. To help address these trends, virtual care has emerged as a secure and private way to connect with a qualified behavioral health care provider. Through a behavioral telehealth visit that may be available through health plans, patients may have a real-time, audio- and video-enabled session with a behavioral health care provider, potentially including psychiatrists, psychologists, Digital Health Care to page 264

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3Digital Health Care from page 24 behavioral nurse practitioners and behavioral master’s-level clinicians. Virtual behavioral health care professionals may be able to help members with various conditions – including depression, bipolar disease, neurodevelopment disorders, anxiety and substance use issues – and produce improved health outcomes, at the same cost, as in-person office visits.

important to remember that good oral health is a first line of defense to help the body protect itself from infections, systemic inflammation and various types of disease such as diabetes and heart disease. For primary care physicians, consider discussing the importance of dental care, and teledentisry, with your patients. Eye Health. Research shows eye health contributes to overall health, as comprehensive eye exams may help with the detection and management of certain chronic conditions, including diabetes, heart disease and high blood pressure.

Dental Health. With dental care ranking among the most avoidable reasons for emergency room Dome physicians are starting to recommend “smart inhalers”. visits, teledentistry may help patients make more informed decisions about when and where to To help improve eye care, some vision plans go for care. Through teledentistry capabilities, are enabling access to virtual care for eye exams, patients may have access to at-home telephone and using the same clinical standards, eye care provider video consultations for advice regarding dental reimbursement and coverage policies as in-person concerns, as well as help with decisions on an appointments. Virtual care can enable remote eye care professionals to appropriate setting for in-person dental care, if needed. While dental practices complete eye exams in a traditional in-person setting staffed by a licensed continue to provide routine care with appropriate COVID-19 precautions, technician. This may be a useful option when eye care professionals are virtual care resources – along with at-home hygiene habits such as brushing not available in person, especially for people with certain chronic health twice a day and daily flossing – continue to take on added importance in conditions that may require frequent eye care. For added convenience for helping people maintain proper oral health and reduce the risk of exposure routine eye care needs, patients may also consider online resources that at in-person visits. When a potential dental emergency occurs, teledentistry enable them to order prescription eyewear and contact lenses, in some cases can help evaluate the severity of the situation and guide people to their for little or no out-of-pocket costs through vision plans. own dentist, a local dentist with availability or a primary care physician. Hearing Health. Hearing health is also connected to overall well-being, And while some people often focus primarily on their physical health, it is as people with hearing loss who obtain treatment experience lower risk of depression, dementia and diminished risk of falls. Health care professionals can play a role in detecting hearing loss, including by in-person testing or by suggesting the use of publicly available online screening resources. If additional hearing care is needed, consumers can then obtain an in-person hearing test from a local, licensed hearing health professional to generate an audiogram, which may be used to purchase customprogrammed hearing aids delivered directly to the person’s home. While home-delivered hearing aids have been previously available, new resources are offering a “direct delivery with virtual care” model. Through these initiatives, people may be able to have hearing aids customized and adjusted (as necessary) through a virtual experience. This new model can reduce the need for in-person appointments for hearing aid adjustments and support, offering greater convenience and affordability compared to traditional models.

Helping physicians communicate with physicians for over 30 years. MINNESOTA

AUGUST 2018

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXII, No. 05

CAR T-cell therapy Modifying cells to fight cancer BY VERONIKA BACHANOVA, MD, PHD

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. 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.

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CAR T-cell therapy to page 144

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Exploring new potential BY MICK HANNAFIN

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.

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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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Considering these emerging technologies – and discussing them with your patients and your health plans – may help encourage improved health outcomes, curb costs and help your practices grow. Moving forward, we anticipate people to increasingly embrace a digital-first mindset, likely opting for care professionals who incorporate technology into their clinical practices and workflows. By leveraging virtual care, wearables, and other forms of connected medical services, health care professionals can make their practices more competitive and responsive to the needs of patients.

FEBRUARY 2021 MINNESOTA PHYSICIAN

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Regenerative medicine focuses on the body’s natural ability to repair, replace, and regenerate damaged or aging tissues. At MINNESOTA REGENERATIVE MEDICINE (MRM), a specialty clinic of HOGUE CLINICS, autologous bio-cellular agents such as platelet-rich plasma (PRP), fat aspirate concentrate (FAC), and bone marrow aspirate concentrate (BMAC) are used to treat degenerative conditions. To ensure proper placement, ultrasound or fluoroscopy guidance is used when clinically indicated during regenerative medicine treatments.

Regenerative medicine treatment categories at MRM include: • Bio-cellular treatment of OSTEOARTHRITIS and CHRONIC TENDINITIS (all peripheral joints & tendons, excluding spine) • Bio-cellular hair restoration for HAIR LOSS, HAIR THINNING, EARLY SCALP BALDING • Bio-cellular treatment of ERECTILE DYSFUNCTION, PEYRONIE’S DISEASE, and PENILE GIRTH ENHANCEMENT

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CARDIOLOGY

Bioprinting 3D heart pumps A concept that is gaining traction BY MOLLY KUPFER, PHD, AND BRENDA OGLE, PHD

eart disease is the leading cause of death worldwide, due in large part to the low regenerative capacity of the heart. With recent advances in stem cell biology, cardiac tissue engineering with human cells has emerged as an avenue to replace lost muscle after a cardiac event and to produce human models in vitro that can be used for disease modeling and testing of drugs and medical devices. Early engineered heart tissues, pioneered in the late 1990s and early 2000s, consisted of geometrically simple structures (strips or rings) made by casting cardiomyocytes in a protein-based gel. While such tissues can recapitulate the contractility of cardiac muscle, their lack of geometric complexity limits their capacity to reflect clinically relevant characteristics of the heart. That is, while they can generate force, they possess no internal chambered structure with which to pump fluid.

“Printing” cardiac tissue 3D bioprinting, wherein structures are fabricated layer-by-layer utilizing a cellladen “bio-ink” as a substrate, has been proposed as a means to generate more geometrically complex tissues from the bottom up. The concept is gaining

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traction, as the ability to print tissues composed entirely of native proteins, cells, and/or biocompatible synthetic components is possible and accessible to many laboratories. Further, robust protocols have been developed for differentiating human-induced pluripotent stem cells (hiPSCs) into a variety of cell types, making it relatively easy to obtain cardiomyocytes ex vivo. However, while researchers have demonstrated the capacity to 3D-print entire heart organ models using biological materials, no one has yet demonstrated electromechanical function of cardiomyocytes within such a tissue. The fact that macroscale contractile function has not yet been achieved in a 3D-printed, perfusable, chambered heart model reflects the challenges associated with handling mature cardiac muscle cells. More specifically, cardiomyocytes do not proliferate or migrate readily. For this reason, it is challenging to achieve the high cell density required for the formation of functional cell-cell junctions while maintaining the structural support needed for an enclosed chamber. Macroscale cardiac function relies on the electromechanical coupling of individual cardiomyocytes to form an organized, synchronously contracting tissue. Traditionally, researchers have taken the approach of differentiating hiPSCs into cardiomyocytes in a tissue culture dish, and then collecting the differentiated cardiomyocytes and 3D printing with them. However, when hiPSCs are differentiated into cardiomyocytes this way, they tend to couple to each other and form a beating monolayer. To collect the cells from such an environment for further downstream applications typically requires one to break up these connections. Hence, to incorporate these cells into an engineered tissue, it is necessary to place them in a context where they can reform these interrupted connections. This is feasible in smaller, millimeterscale tissues, but it becomes challenging in larger, centimeter-scale tissues where the physical distance between cardiomyocytes after printing is too large to overcome.

A new strategy Our alternative approach is to print stem cells, which are highly proliferative, and then induce differentiation of cardiomyocytes in situ following cell expansion. To enable this approach, we sought to develop a bio-ink formulation that: 1. Promotes hiPSC viability; They do not hold dust, dander or pollen like carpet and are much easier to clean. They are surprisingly affordable and increase the value of your home. Properly maintained they should last 100 years. We service metro area residential and commercial projects of all sizes. We offer a wide range of wood options and custom designs for new or existing homes. We also refinish existing wood floors.

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2. Enables hiPSC proliferation and subsequent differentiation into cardiomyocytes; and 3. Is amenable to printing complex structures. Building on our understanding of how native extracellular matrix proteins modulate cell behavior, we developed an optimized bioink formulation composed of native proteins found in the heart. Some of these proteins were chemically modified to enable photo-crosslinking of the printed construct in order to maintain its geometric shape and structural integrity. To generate the printing template, an MRI scan of a human heart was obtained and scaled to the size of a mouse heart such that the longest axis was

MARCH 2021 MINNESOTA PHYSICIAN

approximately 1.3 centimeters. In addition, the septum between ventricles was partially removed to provide a throughway such that unidirectional flow could be propagated through the printed structure for ease of nutrient delivery. The structure was further modified to limit the vascular connections to two major vessels extending from the top of the structure, corresponding to the aorta and vena cava from the digital template. Prior to printing, hiPSCs were mixed into the bio-ink, which was then loaded into a syringe. The bio-ink was extruded from the nozzle using a commercial 3D printer and deposited layer-by-layer according to the print template. The tissues were printed into a gelatin support bath so that the relatively low-viscosity bio-ink would maintain its shape prior to photocrosslinking with blue light. After crosslinking, the gelatin bath was washed away, and the structures were cultured for two weeks to allow the stem cells to proliferate and fill the tissue gaps. The stem cells were subsequently differentiated into cardiomyocytes using a previously developed small molecule-based protocol. This in situ differentiation approach enables the cells to form connections to each other as they differentiate, similar to what would happen in human development. The end result is a living pump that mimics the chambers and large vessel conduits of a native heart while housing viable, densely packed, and functional cardiomyocytes. These human chambered muscle pumps (hChaMPs) exhibit robust macroscale contraction. The cellular makeup is primarily cardiomyocytes (approximately 88%), but there are also other cardiac cell types present, specifically endothelial cells and smooth muscle cells. Importantly, the combined cardiac cell cocktail often fully circumvented

the hChaMP, and the thickness of the wall was typically between 100 mm and 500 mm. However, at its thickest regions, we show that the muscularized region can exceed 500 mm, which is much higher than any previously reported values for engineered cardiac tissues. Cells of the hChaMP robustly express protein markers of cardiomyocyte structural and functional maturation, including gap junctions, ion channels, and intracellular machinery associated with the sarcolemma and sarcoplasmic reticulum. These proteins are necessary for the efficient trafficking of ions, which enables contiguous impulse propagation through the tissue. Optical mapping enabled visualization of electrical signal propagation throughout the hChaMP in real time. The average spontaneous APD80 was 499.9 ± 83.5 milliseconds, and action potentials detected on the surface of the hChaMP reflected a dramatic and predicted response to altered pacing frequency and drug stimulation. The location of the structure from which the activity was propagated was stochastic, sometimes from the large vessels, sometimes from a region near the large vessels, and sometimes near the apex. This outcome likely reflects the accumulation of pacemaker cells or immature cardiomyocytes with the capacity for spontaneous membrane depolarization in a given region that dominates and therefore initiates the response. However, in some cases the spontaneous source of depolarization could be overcome, and the directionality of propagation altered via electrical point stimulation at another location within the hChaMP. Bioprinting 3D heart pumps to page 304

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3Bioprinting 3D heart pumps from page 29 tissues, akin to aggregate-based organoids, but with the critical advantage of harboring geometric structures essential to the pump function of cardiac muscle. The utility of this technology for the field of cardiology is access to a human model system that can sustain flow profiles and exhibit pressure-volume dynamics characteristic of the native heart. This model will therefore be useful for understanding remodeling associated with cardiac disease progression imposed by mechanical insult or genetic predisposition. It will also be useful for testing drug toxicity or efficacy and, given the scale, is amenable to the testing of medical devices, implantation to the heterotopic position in mice, and perhaps, one day, clinical transplantation.

Potential applications The primary benefit of a chambered tissue like the hChaMP is that it can replicate the pump function of the heart, allowing future researchers to trace and track what is happening at the cellular and molecular levels, introduce disease and damage to the model, and study the effects of medications and other therapeutics. To determine pressure volume dynamics as a clinically relevant comparator for this new model system, a conductance catheter harboring a pressure transducer was inserted into one chamber of the hChaMP. The coupling of the pressure transducer with the conductance catheter enabled us to plot both pressure and volume simultaneously as a function of time, which was done for spontaneously contracting and isoproterenol-treated hChaMPs. Pressure-volume vs. time plots were used to generate pressurevolume loops, and from these stroke work could be determined despite the fact that there are no valves to resist emptying and filling. Using the pressurevolume setup, we were able to detect changes in beat rate corresponding to multiple concentrations of isoproterenol. The usual volume moved through the chambers was 0.5 mL and maximum volume moved through the chambers was 5.0 mL, which is approximately 25% that of the average stroke volume of an adult murine heart. Based on these values, we calculated an ejection fraction of 0.7% on average, with a maximum value of 6.5%.

Molly Kupfer, PhD, completed her doctorate in biomedical engineering at the University of Minnesota under the mentorship of Brenda Ogle, PhD. She has utilized human stem cells and 3D printing to generate living, contractile cardiac tissue for therapeutic use and in vitro modeling.

Brenda Ogle, PhD, is professor and head of biomedical engineering, professor of pediatrics, and director of the Stem Cell Institute at the University of Minnesota. Her research team investigates the impact of extracellular matrix proteins on stem cell behavior, especially in the context of the cardiovascular system.

Summing up This advance represents a critical step toward generating macroscale

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with a Mankato Clinic Career Established in 1916, physician-owned and led Mankato Clinic is 100 years strong and seeking Family Physicians for outpatient-only practices.

On the U.S. Army health care team, you will enjoy the satisfaction of providing quality care to Soldiers and their families, in a setting with innovative technologies, robust resources and a dedicated, supportive team.

Over 50% of our physicians are involved in leadership positions and make decisions for our group. Full-time is 32 patient contact hours and 4 hours of administrative time per week. Four-day work week available. Clinic hours are Monday-Friday, 8 a.m.-5 p.m. OB is optional. Call is telephone triage, 1:17, supported by a 24/7 Nurse Health Line. Market-competitive guaranteed starting salary, followed by RVU production pay plan. Benefits include 35 vacation / CME Days annually + six holidays, $6,600 annual CME business allowance and a generous profit-sharing 401(k) plan. We’re just over an hour south of the Mall of America and MSP International Airport. If you would like to learn more about building a Thriving practice, contact:

Learn more at healthcare.goarmy.com/nz72

Family Medicine & Emergency Medicine Physicians • • • • •

Great Opportunities

Dennis Davito Director of Provider Services 1230 East Main Street Mankato, MN 56001 507-389-8654 dennisd@mankatoclinic.com

Apply online at www.mankatoclinic.com

A Place To Be Your Best. Dr. Julie Benson, MN Academy Family Physician of the Year

Immediate Openings Casual weekend or evening shift coverage Set your own hours Competitive rates Paid Malpractice POSITIONS AVAILABLE:

OB GYN & FAMILY MEDICINE – Full-scope practice available (ER, OB, C-Section, Hospitalist, Clinic) • Independent/growing system • Located in the heart of lakes country, Staples, MN • Critical access hospital with 5 primary clinics and a senior living facility • 15 family medicine physicians and 16 advanced practice clinicians • Competitive salary, benefits, and sign-on bonus available

763-682-5906 | 763-684-0243 michelle@whitesellmedstaff.com www.whitesellmedstaff.com

Contact Michael Paul at 218.894.8633, or michaelpaul@lakewoodhealthsystem.com

MINNESOTA PHYSICIAN MARCH 2021

3Clinical Service Lines from page 23

• Can I reconcile the two roles as being equally valuable in service to an integrated mission of patient care, and thereby minimize the risk of seeing myself being caught between distinct and opposing forces (differing missions and obligations) as I make an important decision?

Another bit of counsel for the emerging physician leader is set in an established social psychological theoretical framework (Julian Rotter, 1975); “A person’s behavior is a function of their expectation for rewards that are valued, and the prevailing social psychological dynamics that apply.” Change one, two or all three variables, and motivation and/or actual behavior changes. For physicians, thinking about venturing into The need to control all decisionthe world of organizational leadership, some making leads to a shrinking introspection is required. Four challenging, sphere of effective influence. but practical issues are faced by virtually all physicians as they consider pursuing leadership career opportunities: • What is it that pulls me toward leadership; what are the expected rewards that are more compelling for me than dedication of my professional time and talents to full-time direct patient care?

One final consideration; those most likely to succeed, discover sooner rather than later that success as a leader is less dependent upon their abilities to make all the right decisions for those they lead, than guiding those led to make their own right decisions based upon a clear vision and system of shared beliefs and mission. Physician leaders who fall in love with making all the decisions soon find themselves heading down an entropic professional path; the need to control all decision-making leads to a shrinking sphere of

effective influence.

• How will I best apply a reduced clinical service schedule for the good of the organization and to ensure a satisfying and worthwhile clinical practice for me?

Daniel K. Zismer, Ph.D. is Co-Chair and CEO of Associated Eye Care Partners, LLC, Also, Endowed Scholar, Professor Emeritus and Chair, School of Public Health, University of Minnesota.

• Will the opinions of my peers matter as I make the decision to pursue a full or part-time career change?

Practice Opportunities throughout Greater Minnesota: Our nation faces an unprecedented number of individuals who having served their country now receive health care benefits through the VA system. We offer an opportunity for you to serve those who have served their country providing community based health care in modern facilities with access to world-leading research and research opportunities. We provide outstanding benefits with less stress and burnout than many large system policies create. We allow you to do what you do, best – care for patients.

Minneapolis VA Health Care System Metro based opportunities include: • Chief of General Internal Medicine • Chief of Cardiology • Cardiologist • Internal Medicine/Family Practice • Gastroenterologist • Psychiatrist

Ely VA Clinic

Hibbing VA Clinic

• Tele-ICU (Las Vegas, NV)

Current opportunities include:

• Nephrologist

Internal Medicine/Family Practice

US citizenship or proper work authorization required. Candidates should be BE/BC. Must have a valid medical license anywhere in US. Background check required. EEO Employer.

Possible Education Loan Repayment • Competitive Salary • Excellent Benefits • Professional Liability Insurance with Tail Coverage

For more information on current opportunities, contact: Yolanda Young: Yolanda.Young2@va.gov • 612-467-4964 One Veterans Drive, Minneapolis, MN 55417

MARCH 2021 MINNESOTA PHYSICIAN

•

www.minneapolis.va.gov

Unique Practice Opportunity

YOU’D MAKE A REALLY GOOD DOCTOR IF YOU WEREN’T BEING AN OFFICE MANAGER.

Join an established independent internal medicine practice Be your own boss in a collaborative business model with a healthcare philosophy that puts patients first and allows physicians to have complete control of their practice. The specialties we are looking for are: Internal Medicine, Family Practice, Preventive Medicine, Cardiology, Dermatology, Allergist, or any other office-based specialty. Preferred Credentials are MD, DO, PA, and NP. • Beautiful newly remodeled space in a convenient location • Competitive Wages and a great Professional Support Staff

Contact Mitchell for more information | mitch@brandtmgmt.com 6565 France Ave S Ste 350 Edina

For more information, contact TSgt James Simpkins 402-292-1815 x102 james.simpkins.1@us.af.mil or visit airforce.com

With more than 35 specialties, Olmsted Medical Center is known for the delivery of exceptional patient care that focuses on caring, quality, safety, and service in a family-oriented atmosphere. Rochester is a fast-growing community and provides numerous cultural, educational, and recreational opportunities. Olmsted Medical Center offers a competitive salary and comprehensive benefit package.

Opportunities available in the following specialties: • Active Aging Services - Geriatric Medicine/Palliative Care • Dermatology • ENT - Otology

• Family Medicine • Gastroenterology • Pediatrics

• Psychiatry - Adult • Psychiatry - Child & Adolescent • Rheumatology

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

Send CV to: Olmsted Medical Center Human Resources/Clinician Recruitment 210 Ninth Street SE, Rochester, MN 55904

email: dcardille@olmmed.org • Phone: 507.529.6748 • Fax: 507.529.6622

www.olmstedmedicalcenter.org MINNESOTA PHYSICIAN MARCH 2021

3E-referral Solutions from page 19 questions in many of the categories inquire about sensitive and personal aspects of our patients lives and the screening process must be implemented with corresponding sensitivity. E-referral processes have demonstrated value for patients and there is more work to be done from a data analytics perspective to link SDOH screen data sets with outcomes based on clinical data.

Available Options

data and put this data on track to be exchanged and protected with appropriate consents and HIPAA compliance (we have minimal ICD-10 “Z codes,” but not enough granularity). One effort is the Gravity Project facilitated by the HL7 standards organization. As is the case with any set of health care data, there are emerging requests to collect, store, and mobilize SDOH data and optimize it through aggregation and analysis for many purposes.

An electronic social needs referral is indeed akin to a prescription.

A small handful of vendors have been active in the national e-referral space such as Aunt Bertha, Healthify, NowPow, UniteUs and a few others. NowPow was the first to establish health care clients in Minnesota (Minneapolis, St. Paul metro), followed by Aunt Bertha. UniteUs has recently announced a partnership with CyncHealth (formerly the Nebraska Health Information Initiative) and is seeking to establish clients in Minnesota. While there are some general similarities in the workflows of these vendor products, each of them has a different approach and price point. Where one may focus on health care and referring to the community, another may start by building a community coalition, then bringing health care providers in as stakeholders.

There is much that can be done by better understanding and addressing the 80% social determinants component of patient health that is influenced and largely determined in the community and outside the boundaries of the 20% determined in the health care arena. Payment models such as ACOs that enable flexibility in how we help patients achieve their best possible health are just one avenue to connecting health care to community and taking advantage of the e-referral solutions that are rapidly being adopted across our state and nation. Reid Haase, MA, is a Senior Healthcare IT Consultant, Practice Facilitator

and works with Quality Improvement at Stratis Health.

Just as there are efforts to enable EMRs to share data, the same need is under discussion in the national conversations around SDOH to standardize

“The Hub helped me get back on Social Security so that I could pay my bills while I continue to work on my health.”

MARCH 2021 MINNESOTA PHYSICIAN

Resources, tools, solutions. With Disability Hub MN, you can put an essential resource directly in your patients’ hands. From explaining health coverage options to submitting medical benefit applications, Hub experts are uniquely positioned to support people with disabilities.

MINNESOTA PHYSICIAN MARCH 2021

Holly Boyer, MD

TRANSFORMING HEALTH & MEDICINE Leaders • Educators • Innovators

mphysicians.org

Minnesota Physician • March 2021

Articles inside

CARDIOLOGY Bioprinting 3D heart pumps

TELEHEALTH Digital Health Care

COVID

BEHAVIORIAL HEALTH Facing a Psychiatric Bed Crisis

INTERVIEW

ADMINISTRATION Clinical Service Lines

SOCIAL DETERMINANTS OF HEALTH E-referral Solutions