Minnesota Physician • May 2020 by Minnesota Physician Publishing

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THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXIV, No. 02

Diagnostic accuracy A dose of insight BY ROBERT HANSCOM, JD; MARYANN SMALL, MBA; AND ANN LAMBRECHT, RN, BSN, JD, FASHRM

early 84% of adults and 93% of children will have contact with a health care professional each year in the United States. (See https://tinyurl.com/mp-stats.) These patients and their caregivers are ultimately asking for two things—an accurate diagnosis and an appropriate treatment plan. While arriving at a timely and accurate diagnosis for every single patient may not always be possible, it is always the goal. Diagnostic accuracy is far from simple. In fact, diagnosis-related events are the single largest root cause of malpractice claims. Health care providers can benefit from fresh perspectives, data-driven insights, and new ways of thinking about everyday activities.

Implementation science The systematic uptake of change

A fresh approach to claims data Our conclusions from analysis of claims data are not absolute findings, but hypotheses: signals from the past about where vulnerabilities existed and may still be at play. Diagnostic accuracy to page 124

BY HILDI HAGEDORN, PHD, LP

ccording to Martin Eccles and Brian Mittman in their introduction to the new journal Implementation Science in 2006, implementation science is “the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services.” Implementation science was born out of the fact that evidence-based medical treatments do not tend to organically make their way into standard clinical practice. Many are never fully implemented or take years to move from research into practice.

Implementation science to page 104

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Volume XXXIV, Number 2

COVER FEATURES

Implementation science

Diagnostic accuracy A dose of insight

The systematic uptake of change

By Hildi Hagedorn, PhD, LP

By Robert Hanscom, JD; Maryann Small, MBA; and Ann Lambrecht, RN, BSN, JD, FASHRM

DEPARTMENTS

L RS EA IN F L L T H U E N T I AA D E C A R E LE

Publication Date: November 2020

Nominate the 100 Most Influential Health Care Leaders In our November 2020 edition, Minnesota Physician will profile 100 of

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INTERVIEW

PROFESSIONAL LIABILITY 20 Medical directorships

our state’s most influential health care leaders. In a format featuring

Due diligence prior to accepting an offer

responsible for making Minnesota a global model for health care delivery.

Preserving independent practice

By Antonio “Tony” Fricano, JD

Owen O’Neill, MD Infinite Health Collaborative

BEHAVIORAL HEALTH 22 Addressing patient stress during a pandemic

PATIENT COMMUNICATIONS 16 Sharing a life-threatening diagnosis with children Developing best practices

By Vaida Kazlauskaite, MS, LAMFT; Tai Mendenhall, Ph.D., LMFT; and Kirby Clark, MD PAIN MEDICINE 18 Targeted drug delivery

How physicians can help By Todd Archbold, LSW, MBA

PUBLIC HEALTH 26 Health care facility design

photos, bios, and quotes, we will highlight the men and women most These individuals will represent every aspect of the industry: physicians, business executives, political leaders, policy analysts, etc. We invite you, our readers, to participate in this recognition process. If you know anyone within your organization you feel should be considered, please fill out the form below and mail it or submit online (www.mppub. com/top100.html) or via e-mail (comments@mppub.com) prior to September 25. We welcome your input and participation in making this list as comprehensive and meaningful as possible.

Lessons learned from the pandemic By Mike McMahan and Alena Sakalouski Johnson, AIA, ACHA

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Nominee’s title: Nominee’s affiliation:

Brief description of the nominee’s work and influence:

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

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U of M researchers launch hospitalization tracking project Two University of Minnesota research centers have launched an urgent project to better understand state-by-state hospitalization data. The COVID-19 Hospitalization Tracking Project (https://tinyurl. com/hcn-tracking) currently reports data from 37 states. The site captures and tracks daily data on the number of COVID-19 hospitalizations— as reported by states’ Departments of Health—along with each state’s hospital bed and intensive care unit capacity. The site allows users to visualize and compare hospitalization activity between states. “Whereas each state collects its own data, we wanted to make it easy to share and analyze data across states,” said Pinar Karaca-Mandic, associate professor at the Carlson School of Management and academic

director of the Medical Industry Leadership Institute. “This wasn’t possible until we launched this project, and this is the first time that a comprehensive national view of the data is available.” The hospital utilization data is adjusted for each state’s population to allow for valid comparisons.

Drug price transparency bill clears Legislature; signed by Governor Minnesota Gov. Tim Walz recently signed the state’s Prescription Drug Price Transparency Act (SF 1098; HF 1246), which requires drug makers whose products hit certain price increase thresholds to provide advanced notice and justification of the increases to the Commissioner of Health. Manufacturer reporting on the drugs—which includes information on manufacturing costs, marketing, and sales—will

be published by the Minnesota Department of Health The bill passed the House 99–33 after passing the Senate 63–2. The provision had been included in a health omnibus bill in 2019, but was removed when the bill went into conference committee due to pharmaceutical industry concerns about trade secret violations. Though changes were made to be more protective of industry secrets, drug manufacturers still opposed this year’s legislation. Rep. Kelly Morrison, MD, DFL-Deephaven, said the bill is meant to draw attention to big price increases and their role in rising health care costs, adding that taxpayers foot the bill for increases in government health programs. The new law takes effect in October 2021 and covers three classes of prescription drugs: those that are $100 or greater for a 30-day supply (or $100 for a course of treatment lasting less than 30 days); brand-name drugs

that have increased in price by 10% or more over the previous 12 months (or 16% or more over the last 24 months); and generic drugs that have price increases of 50% or more over the previous 12 months. Companies that fail to follow the law face fines of up to $10,000 per day.

Juniper offers its “Stay Well in Your Home” classes online Wellness courses are now available online through Juniper, an initiative of Minnesota’s seven Area Agencies on Aging that promotes self-managed health and well-being. Over the past year, Juniper providers have led more than 500 wellness classes in communities across Minnesota. In March, all community-based Juniper courses were canceled due to COVID-19. These courses, once conducted in person,

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Ryan Ellis

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are now moving online to offer classes in the safety of participants’ homes. The live, online courses are facilitated by trained and certified leaders and limited in class size to ensure sharing and interaction. The courses offer materials designed to help individuals eat healthier, increase physical activity, work better with health care professionals, and feel better. Small-group classes are held on HIPAA-secure and easy-to-use video conferencing, allowing real-time engagement with course leaders and fellow participants. Learn more at https://tinyurl. com/hcn-juniper or call 855-2152174 to speak with a Juniper specialist about options. Registration is limited to ensure small class size.

Minnesota modifies human services policies during pandemic The Minnesota Department of Human Services (DHS) has temporarily modified more than 30 rules and regulations to preserve access to critical human services such as health care, economic assistance, and childcare during the pandemic. The scope of the emergency waivers and modifications is unprecedented in the history of the state’s human services programs. With more than one in five Minnesotans relying on these programs, the changes have unfolded in stages: Health and safety. To ensure that people don’t lose health care coverage or other vital support services such as economic assistance and childcare, DHS made changes to postpone renewals for state health insurance programs and allow for a 90-day supply of maintenance medications. Telemedicine and other remote

services. Changes were made to

ensure that people could get care and services through phones and computer screens.

DHS works to support providers as they continue services to keep people as connected and healthy as possible. On April 24, Gov. Walz signed an executive order to ensure that people who rely on state health care and economic assistance programs won’t be penalized for receiving federal stimulus money. In collaboration with interagency work groups established by Gov. Walz and Lt. Gov. Peggy Flanagan, DHS has also been distributing emergency funding across the state for housing and childcare providers and issuing emergency food aid to individuals and families who rely on SNAP, the Supplemental Nutrition Assistance Program. Workforce

challenges.

Executive Master of Healthcare Administration MHA

Minnesota’s Highest-Ranked Management Degree for Healthcare Leaders (pictured: Dr. Gigi Chawla, MHA ’17)

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Telehealth services up sharply in state Nine Minnesota health systems reported a 1,000-fold increase in the use of telehealth services in the wake of the COVID-19 pandemic, according to a Stratis Health survey. The independent nonprofit organization convenes a Virtual Health Sharing Group of health system telehealth directors, representing 11 systems in Minnesota. Since 2017, the group has discussed telehealth implementation progress, challenges, and priority topics. With the coronavirus outbreak, the group increased meeting frequency to discuss strategies around the rapidly changing telehealth guidelines and approaches. The latest survey provides a snapshot of the expanding telehealth use. Prior to the coronavirus outbreak, the nine responding Minnesota health systems reported a collective 1,149 telehealth visits per day. Since COVID-19, the health systems reported conducting a collective 15,480 telehealth visits per day as of April 24. These new telehealth visits were proportionate in mode of delivery, with 7,612 telephone visits and 7,868 video visits.

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Top challenges reported by Minnesota health systems in this rapidly expanding telehealth care: • Educating staff and physicians on workflows. • Scaling up issues related to equipment availability and deployment. • Understanding coding/ billing to obtain appropriate reimbursement. • Facilitating and supporting telehealth encounters from the patient side.

donations of high-thread count, cotton, homemade face masks, as well as bouffant caps. Dustin Maddy, Incident Command, Community Sourcing Lead, asked the communities to provide the supplies for staff, long-term care residents, and patients that don’t already have masks. CentraCare and Carris Health offer specific patterns for face masks and bouffant caps online. Drop-off locations for personal protective equipment are available across Central Minnesota.

Care systems seek community help

UCare provides members COVID-19 financial relief

CentraCare and Carris Health facilities have identified a novel source of protective gear for their clinical staff, long-term care residents, and patients: private homes. The facilities are asking for the community’s support through

As COVID-19 continues to impact Minnesotans’ safety, health, and financial security, UCare is taking several actions during the duration of federal and state public health emergencies to make health care more accessible and affordable:

• Reducing member premium payments by 20% in July and August 2020. • Removing copays for Medicare primary care and mental health clinic services—including telehealth—during the COVID-19 public health emergency. • Continuing to waive copays, coinsurance, and deductibles for COVID-19 tests and associated clinic, urgent care, and emergency room visits. • Continuing to waive copays, coinsurance, and deductibles for COVID-19 inpatient hospitalizations through September 2020. • Supplying health care providers, group homes, nursing homes, assisted living facilities, social service

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organizations, and vulnerable members with telehealth home kits, masks, healthy snack boxes, and iPads. • Offering $25,000 grants to small provider groups and community clinics to build infrastructure during COVID-19. In the past few months, members’ use of health care services and associated claims were lower than expected due to COVID-19. This enabled UCare to offer members financial relief and providers resources to ease the way for them to reconnect. Medicare members also have access to over-the-counter Healthy Savings to purchase preventive care items such as masks, gloves, or hand sanitizers at participating stores. UCare members can utilize telehealth services available to them in the safety of their homes.

MEDICUS

Jason Klipsic, DO, has been named as St. Luke’s first chief medical information officer. In his new role, Dr. Klipsic will provide guidance and expertise in analysis, design, configuration, implementation, process improvement, and ongoing support of clinical information systems to support patient care. He will continue working part time as a hospitalist. Jeffrey F. Klassen, MD, a fellowship-trained orthopedic surgeon, has joined Twin Cities Orthopedics (TCO). Dr. Klassen’s clinical interests include shoulder care, elbow care, wrist care, hand care, fracture care, pediatric care, and sports medicine. Dr. Klassen is board-certified by the American Osteopathic Board of Orthopaedic Surgery. He will practice at the Edina–Crosstown location. Bruce Cantor, MD, MS, has joined UCare as medical director. In his new role, Dr. Cantor will be responsible for conducting day-to-day medical management and leading ongoing improvement in collaboration with Health Services, providing guidance to the utilization management, appeals, medical policy, and quality improvement teams. He will also provide clinical support as needed for complex case management, disease management, and vendor services.

Minnesota Orchestra at Home watch. listen. learn. Minnesota Orchestra at Home features content created by our musicians. Enjoy listening, learning and watching as they present mini-concerts from their home to yours.

Malini DeSilva, MD, MPH, an investigator at HealthPartners Institute, is coauthor of a CDC-published report documenting that vaccinations for measles have dropped significantly since January. The report also noted a steep decline in purchase orders for routine vaccines. She stressed the need for routine vaccinations to decrease the risk of future outbreaks of preventable diseases. Marc Martel, MD, an emergency physician at Hennepin Healthcare, has developed an aerosol protection box to protect from the fluids that spray from the patient’s mouth when receiving respiratory treatment. His first model—built with supplies from local hardware stores—prevents nearly 99% of the exposure during intubation. Local hospitals and the University of Minnesota have also developed aerosol protection boxes.

Principal Cello Anthony Ross and his mother-in-law, Mary Rapier, perform Solveig’s Song by Grieg.

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INTERVIEW

Preserving independent practice Owen O’Neill, MD Infinite Health Collaborative Please tell us about Infinite Health Collaborative (i-Health).

checkup tests that cannot be done virtually: blood pressure, baby’s heartbeat, position of the baby, and vaccines. Similarly, Twin Cities Orthopedics (TCO) launched virtual care in under seven days, going from zero telemedicine infrastructure to providing over 1,000 virtual care visits per week. The best part is we did so without sacrificing the patient experience. Niney-nine percent of TCO’s virtual care patients say they would recommend this service to family and friends.

We like to say that i-Health is a modern approach to a timeless idea. We’re an independent practice of like-minded physicians representing several unique specialties, including cardiology, colon and rectal conditions, family medicine, orthopedics, and women’s health. All of us believe that independence in health care enables physicians to focus on each patient’s individual goals without limitations, and that’s the inspiration behind i-Health. By empowering patient choice—arming patients with the tools to make their own educated health care decisions—we are earning their trust and keeping health care personal. In a nutshell, we deliver valuebased care, enable physician autonomy, and preserve patient choice.

Revo Health, a management services organization, helps practices develop value-based care services and provides support across several departments often referred to as “back of house.” These include revenue cycle, finance and accounting, human resources, information technology, quality, marketing, and more. Sharing these resources creates efficiencies and cost savings, fosters collaboration, and consolidates our expertise. Revo takes care of the business side, so physicians can focus on taking care of patients. What kind of framework for growth and sustainability of independent physician practices does i-Health provide?

There’s power in numbers. By banding together, we preserve our independence and strengthen our voice in the industry. These days, many small practices are getting squeezed out or bought up by large systems, and transition to becoming employed by the system. i-Health is physician-owned and led, however, so every new physician to join becomes a fellow partner and retains ownership stake in the business. Another major advantage for our operating divisions is collaborative learning. Innovative operational initiatives such as developing prospective care bundles and collecting outcomes data takes time to develop. We’ve all experienced different

MAY 2020 MINNESOTA PHYSICIAN

“...” patient-physician We believe relationships are the heartbeat of health care. “...”

Please tell us about Revo Health and the services it provides for i-Health physician groups.

What can you tell recent medical school graduates about the opportunities and benefits presented by the independent practice of medicine?

stages of growing pains, so we help each other avoid re-inventing the wheel. How can independent physicians be the drivers of the industry’s improvement?

We believe patient-physician relationships are the heartbeat of health care, and we intend to keep it that way. Independent physicians have autonomy to guide patients without the limitations of larger systems, and ultimately enable patients to make their own educated health care decisions. Getting back to basics and putting the power back in patient’s hands is how we believe the industry moves forward. What are some examples of how independent physician practice contributes to innovation in the health care industry?

Our independence enables us to mobilize and test new ideas quickly without the red tape of many larger systems. In the past couple of months, for example, OB-GYN specialists from our women’s health operating division launched curbside obstetric care in response to COVID-19, performing routine

Our model, which centers around the patientphysician relationship, is the original health care model. Many physicians are attracted to independent practice because it reminds them why they got into medicine in the first place. i-Health provides immediate and long-term financial stability, and independence puts you in control of your own destiny. By building a strong reputation, and delivering exceptional care day in and day out, the sky’s the limit to your potential. What are some of the ways i-Health members encourage patients to be active participants in their health care decisions?

It sounds so simple to do this, but it’s not our job to tell patients what to do. We encourage patients to be in control of their own health, and it’s our job to guide patients to make the best decisions for themselves. We accomplish this by clearly explaining diagnoses, walking them through options, listening to their concerns, and answering their questions. We also use anonymous clinical outcomes data from over one million survey submissions to set realistic expectations. For example, we can tell patients considering a hip replacement that six months after surgery, 97.93% of total hip arthroplasty patients reported little to no pain lying in bed and turning over. What benefits can i-Health provide to self-insured employers?

It’s amazing how many employers are simply unaware of the freedoms they have when it comes

to customizing their benefits plans. For example, they can partner with us tomorrow to give their employees more surgical care options and better outcomes via our TCO EXCEL Surgery & Recovery program, without changing anything else about their existing plan. It’s a simple add-on model, and the best part is it actually reduces costs across the board. In fact, some local employers have already identified i-Health as a preferred tier inside of their health plans, effectively encouraging their employees/patients to consider value-based care options. New health care legislation is informed by considerable input from health plans, hospitals, and the pharmaceutical industry, but very little from physicians. How can i-Health help address this inequity?

This is a big reason why we were inspired to band together in the first place: to grow our shared voice in the industry. A voice that is focused on patient care and the delivery of innovation in the market. We deliver value-based care, which means we have actual data to prove how we can improve outcomes and patient satisfaction, while also reducing costs. We’re putting the data to good use in these conversations.

What can you tell independent physicians who may want to become part of i-Health?

We live and succeed on our own reputation, and often take the road less traveled, which isn’t for everyone. We were founded upon the promise that no matter what, the care of our patients would always come first. It’s in our DNA, and it’s what drives us every single day. The freedom we are granted as an independent practice allows us to be innovative, create meaningful solutions to complex problems, and deliver on that fundamental promise. And, ultimately, it’s how we provide value. If your core motivation as a health care provider aligns with our core principles, and you share our vision for the future of value-based care, then we would love to get to know you better. The recent government response to cancel “elective” surgeries brings up several important issues. What are your thoughts on this?

On the orthopedics side in particular, we have seen many patients suffering as a result of elective surgery restrictions. We have observed increased opioid drug use and suicide attempts from patients dealing with severe pain and immobility, in addition

to prolonged pain leading to poor long-term outcomes. Prolonged waiting causes stress physically, mentally, emotionally, and financially. Treatment for many of these patients was initially categorized as elective or non-essential when the COVID-19 pandemic began. The good news is that we have developed comprehensive safety protocols that have enabled us to perform more surgeries in a safe, COVID-free environment within ambulatory surgery centers. We are using a clinical risk stratification tool to determine which surgeries can be performed first, we’re testing patients and employees for the virus, we’re screening at entrances, and much more. Our patients and their families have high expectations for their care, and we want our safety standards to exceed those expectations. Owen O’Neill, MD, is a board-certified orthopedic surgeon with fellowship training and subspecialty certification in sports medicine. He is a board member for both Infinite Health Collaborative and Twin Cities Orthopedics.

WHITE EARTH INDIAN HEALTH SERVICE IS EXPANDING This outpatient clinic is soon ready for construction activity on new space for patient registration/benefits, primary care, pharmacy, physical therapy, dental, conference/training rooms and the facilities entry/lobby/waiting. Renovated areas will include radiology, lab, eye care, audiology, behavioral health, WIC, administration, medical records, and IT.

EAPC.NET/IHS-WHITE-EARTH

MINNESOTA PHYSICIAN MAY 2020

3Implementation science from cover A current example

Implementation science can, and has, worked to identify strategies to overcome many of these barriers and works to spread these solutions to additional health care and substance use disorder treatment settings.

Given the intense focus on the opioid epidemic, the state of treatment for A new discipline opioid use disorders provides just one example of the type of gap in clinical Implementation science is relatively early on in its care that highlights the need for implementation lifespan as a scientific discipline. Theories, models, science. Evidence-based medications (methadone, and frameworks have proliferated to guide and buprenorphine/naloxone) that are highly effective inform successful implementation. To date, there for treating opioid use disorder have been available is not one prevailing theory, model, or framework. for decades. Yet it is still not the norm for patients Evidence-based medical However, many commonalities exist among them with opioid use disorder to receive these medications. treatments do not tend to and some essential ingredients for successful The reasons for this include health care system, organically make their way implementation are starting to become evident. The organizational, and provider-level factors. Substance into standard clinical practice. essential ingredients described below are based on use disorder treatment has traditionally been those commonalities as well as 20 years of in-theprovided outside of the health care system such that trenches implementation work. many substance use disorder treatment facilities do The first step to successful implementation is not have medical providers on staff. These traditional to identify a clearly defined and measurable gap in systems also continue, in some cases, to maintain a practice. This requires the ability to measure the practice of interest, which philosophy that frowns on psychiatric medications. Within the health care has become easier with the expansion of electronic medical records. So, one system, primary care providers generally were not trained to identify and might identify all patients with a diagnosis of opioid use disorder and the treat substance use disorders. Providers are wary of medication treatments percentage of those patients who are receiving evidence-based medication for opioid use disorders because of Drug Enforcement Administration treatments. While it might not be possible to identify the â&#x20AC;&#x153;correctâ&#x20AC;? requirements for training and licensing to prescribe them. They express percentage, comparison to rates of guideline-recommended prescribing concerns about the time to provide care management for complex patients for other medical conditions may serve as a guide. For example, rates of in already overburdened practices. guideline-recommended prescribing for hypertension and for depression well exceed those for opioid use disorder in most settings. The metric can also be used to provide continuous feedback on progress toward implementation goals, another key ingredient for successful implementation. Second, it is important to have an in-depth understanding of current practice and the barriers to change in the local environment. This type of local information is generally gathered through interviewing key individuals. It is important to talk both to those that are likely to be supportive and not supportive of the effort in order to get a full range of perspectives. Through these local interviews, key stakeholders who are interested in directly participating in an implementation effort are likely to begin to emerge. Stakeholders should include representation from all levels of the clinic, such that high-level leaders are included as well as providers and support staff. Any role in the clinic that will be impacted by the implementation effort should have representation when discussing how the implementation plan will unfold. Local stakeholders must include someone who is in a position of leadership with the power to set the agenda for the clinic, as well as individuals who have the interest and time to invest in the day-to-day work of moving implementation forward. Next, it is important to define an individualized plan for the clinic. There are many different paths that a hospital or clinic could take to reach the same end goal. For the medication treatment for opioid use disorder example, there might be one provider identified that wants to treat these patients in a specialized team that may have some additional resources dedicated to it, or the clinic may decide that every provider should be able to provide this treatment to the patients on their panel. Patient care management may be done by each provider, by a care management nurse, or by a clinical pharmacy specialist. The details depend on the resources available and what is acceptable to the staff. By individualizing the plan to the specific clinic environment, using input from key stakeholders and

MAY 2020 MINNESOTA PHYSICIAN

others within the clinic, the clinic develops a sense of ownership over the plan that is key to maintaining focus.

type of work is of value to their systems and to back this up with resources. They will need to support individuals trained in implementation research and practice to serve as facilitators within their system or support growing that knowledge within their practice. They will need to express a willingness to hear from staff about gaps in evidence-based practice, allow time for staff to develop and test organic solutions, and reward and recognize innovation.

It is also essential to have a “facilitator.” This refers to an individual whose role it is to manage the implementation intervention. They are separate from the local stakeholders in that they are usually external to the clinic and serve as a manager of and a resource for the implementation team. They need to have training or expertise in Whether a large health care system or a small implementation. They do not have to have specific private practice, the key is to have a continued clinical expertise, but they should have a basic focus on learning and improving, and this requires understanding of the evidence base and connections Implementation science is dedicated time to consider such issues. Clinicians are to clinical experts whom they can call on for advice. relatively early on in its lifespan often stressed, overworked, and focused on getting They can provide the local stakeholders with the as a scientific discipline. through each day. Change is always difficult but resources they need or track down resources or even under these circumstances it is almost impossible. create them, for example, if local stakeholders request Wide uptake of applied implementation will require an informational brochure for patients or a newsletter a restructuring of health care system and practice to share their progress with organizational leadership. priorities to dedicate resources to the endeavor. They also are the glue that maintains the focus on the implementation goals. Any stakeholder, whether they are in a leadership role or a clinical role, is constantly bombarded by the “crisis Hildi Hagedorn, PhD, LP, is a principal investigator and Director of the of the day.” The facilitator maintains contact with the team and focus on the Implementation Core at the Veterans Health Administration Health Services implementation goals on a regular basis.

Research & Development Center for Care Delivery & Outcomes Research

Challenges and responses

located at the Minneapolis VA Medical Center. She is also an associate

As mentioned earlier, implementation science is a relatively new discipline and as such, there are ongoing challenges facing the development of the field. Key among these is the development of reliable and valid measures of the constructs that are theorized to impact implementation success as well as the outcomes of implementation efforts. Many quantitative measures have been developed and used in individual projects. Only a few have been rigorously evaluated. The added challenge is that measures must be feasible for completion by busy health care providers. While some quantitative measures are promising, at this time, qualitative methods are essential to confirm and supplement the information gained from quantitative measures, as well as to understand the unique challenges and strengths of a particular local environment.

professor in the Department of Psychiatry in the School of Medicine at the

A second challenge is defining what aspects of an evidence-based clinical intervention are core and, therefore, cannot be adapted without compromising effectiveness versus those aspects that can be adapted to meet the needs of the local environment. This is relatively easier for interventions such as pharmacological treatments. However, for complex behavioral interventions, this becomes more challenging. Are aspects such as the format (group vs. individual; face-to-face vs. virtual) and timing (weekly vs. bi-weekly) adaptable or not? For these reasons, it is essential to define the presumed core elements in advance, preferably in consultation with the intervention developer, and also have a methodology in place to document adaptations and, if possible, their impact on patient outcomes.

Translating methods While most implementation science work has been conducted by implementation researchers working in collaboration with large health care systems, the field is also concerned with how to translate implementation science methods more broadly into health care settings. This has led to an interest in “applied implementation,” or the practice of implementation outside of the research context. The question is what is needed for health care settings to scale up and conduct this work independently? First, the highest levels of health care leadership need to buy in to the idea that this

University of Minnesota. Her research focuses on implementation of evidencebased practices for the treatment of substance use disorders.

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3Diagnostic accuracy from cover

• Implement and use a template to serve as a checklist when performing the physical examination.

Typically, a fully investigated liability claim will contain valuable information, such as allegations of primary and secondary causes, patient health and demographic information, injury severity, physician specialty, risk management issues, location of the alleged error, human and financial costs, and expert reviews and opinions. We use this information to create evidence-based recommendations to mitigate risk.

• Establish a routine for updating family history regularly. Include reminders and prompts in the electronic health record (EHR).

Leading causes of claims Diagnosis-related events result in indemnity payments just slightly higher than the next five highest categories combined. Our study found that 53% of diagnosis-related claims include risk management issues involving poor clinical decision-making; 54% are high-severity cases, with 36% resulting in death; and 36% stem from outpatient (office setting) locations.

Rethinking the diagnostic process It’s estimated that 10–20% of all medical diagnoses are inaccurate (see https://tinyurl.com/mp-accuracy). Thirty-three percent of diagnosticrelated claims and 26% of associated indemnity payments allege that a breakdown in decision-making occurred during the patient’s H&P (patient/ family history and physical examination). Recommendations: • Develop a policy that requires obtaining and documenting specific elements of the H&P.

Diagnostic/lab testing The four discrete phases of testing (ordering, performance, receipt/transmittal, and interpretation) trigger 52% of diagnosis-related claims and 55% of indemnity payments. Recommendations: • Provide decision support tools to assist providers in ordering proper diagnostic tests. • Implement a protocol to obtain and document patient specimens. • Implement a process for patients to obtain outstanding test results, as well as contact information to follow up.

Referral management Nine percent of the diagnosis-related claims we examined were attributed to referral management. Recommendations: • Develop a consultation policy that includes criteria for a provider to consider when deciding whether and when to obtain a consultation, and when a consultant must directly manage the patient. Hardwire this policy into the EHR. • Develop and embed into the physicians’ workflow processes for all transitions which require communication and documentation of specific patient status information and medications. • Implement a chain-of-command policy that outlines the process to escalate patient treatment differences to an ultimate decisionmaker. Train and reward for adherence. • Develop a follow-up process for patients who have been referred to a specialist, including patient contact and follow-up appointments.

Physician follow-up Allegations involving inadequate physician follow-up with the patient accounted for 5% of claims and 7% of indemnity paid. Recommendations: • Provide the patient with written instructions that describe the diagnosis, expected results, side effects, or new symptoms that could arise and require attention; whom to contact with concerns; and suggested follow-up care. • Ensure that the patient’s primary care provider receives a copy of all patient instructions, as well as test results and information on follow-up appointments. • Consider various communication methods, such as secure online patient portals, email, and a designated telephone line. • Develop a call-back system for patients with certain high-risk presentations to determine whether symptoms have subsided and that instructions have been followed. • Engage the patient. Assign them the job of reporting back key symptoms.

MAY 2020 MINNESOTA PHYSICIAN

Missed and delayed diagnosis of cancer Among malpractice claims that allege a diagnostic failure, the largest number involve a missed or delayed diagnosis of cancer. The top four cancers involved in such claims have always been breast, lung, colorectal, and prostate, though the exact order periodically shuffles. In the case of breast and lung cancers: • The majority of claims alleging diagnostic failure were filed against radiology practitioners. • The leading clinical judgment issue was misinterpretation of diagnostic studies (47% of lung cancer claims and 44% of breast cancer claims). We believe that poorly written diagnostic/radiology reports are a major contributing factor. In the case of colorectal, lung, prostate, and oral cancers: General medicine practitioners are the focus of most allegations involving these cancers. They are pulled into these cases largely because of their role as the overall manager of the patient’s care. In 2016, the highest number of new cancer cases among men were cancers of the prostate, lung and bronchus, and colon and rectum, while the largest number of new cancers in women were cancers of the breast, lung and bronchus, and colon and rectum—the exact top four cancers involved in allegations of diagnosis-related failure, and the same cancers that are on the rise in the United States (see https://tinyurl.com/mp-cancer-stats).

• Implement ongoing over-read or second-evaluation processes, with feedback to radiologists. • Provide decision support tools. • Develop criteria for when a second read of a film must be performed and the stated time frame for completion. • If teleradiology is practiced, conduct regular testing for film and transmission quality. • Develop standardized report templates that require specific elements, such as suspected and ruled-out conditions, as well as the probable diagnosis and recommendations. Include a summary of findings at the beginning. • Forbid disclaimers or language such as “dictated but not read.”

Diagnostic accuracy: cardiac and vascular issues Cardiac and vascular issues represent 8% of diagnosis-related claims. Taken together, heart problem (non-MI), myocardial infarction (MI), and thrombosis/ clot/emboli were involved in 12% of diagnosis-related claims. These issues were almost as frequent (12% vs.13%) in our study as infections (pneumonia, sepsis, MRSA, sinusitis, etc.) and were more frequent than fractures/dislocations (a historically common condition in diagnosis-related claims). Heart and vascular issues can be difficult to diagnose because symptoms can vary from patient to patient and can mimic symptoms for other common ailments. Because these issues are so often fatal, it’s important that

The role of radiology in cancer diagnosis More than half of diagnosis-related claims involve an allegation that something went wrong during one of the testing steps, specifically diagnoses involving radiology and the presence of cancer. The vast majority of breast- and lung- cancer claims allege that the radiologist was the specialist most accountable. Quality improvement processes that provide honest feedback to radiologists on the accuracy of their reads may not be as robust as they ought to be, which may lead radiologists to conclude their accuracy rate is higher than it is. Also, when radiologists are unsure of their interpretation, there may not be decision support tools in place or an avenue to obtain a second opinion without embarrassment or retribution. Further, ongoing education on common and unusual diagnostic pitfalls may be lacking. Teleradiology provides a valuable service for facilities that cannot support an in-house radiologist around the clock, but it can also contribute to missed diagnoses if film and transmission quality are suboptimal. Sometimes a sound diagnosis and an optimal outcome comes down to the writing and communication skills of the radiologist and/or the ability of the ordering provider to interpret information. Radiology reports that contain many possibilities but no definitive diagnostic information can be confusing, and do not aid in developing a care plan. This problem is further compounded when the report includes disclaimers and multiple recommendations without a sound basis to implement them. Recommendations: • Revisit peer review practices to ensure that they include how to measure and communicate periodic evaluation of clinical outcomes and compliance with established quality indicators and when performance may warrant closer review.

Diagnostic accuracy to page 144

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3Diagnostic accuracy from page 13 diagnostic testing be thorough and timely and that practitioners obtain a complete patient and family history.

Helping physicians and patients to do better, together Below are important questions to consider in helping physicians and patients work together in the quest for diagnostic accuracy. • How might we re-engineer the diagnostic culture to calibrate confidence and accuracy? In most practices and hospitals, there is no standardized or safe way to document a provider’s degree of uncertainty. • What kind of structures, consultation practices, and processes could be put in place for cases in which there is a high degree of diagnostic uncertainty?

In addition, peer review may not be as robust in a small practice. All the providers may be similarly trained and approach diagnoses the same way; every provider in the practice may not feel comfortable offering alternatives to another provider; and there are typically no expert resources within an office practice that can provide guidance. Finally, the practice may not have access to clinical decision support tools that can assist in diagnosing and developing the appropriate treatment during the first patient encounter. Recommendations: • Explore available clinical decision support tools and use claims data to justify investing in one or more of these tools. • Obtain national, state, and regional statistics on practice guidelines regarding the diagnoses treated within the clinic or practice. • Collect and compare clinic or practice data and clinical outcomes with the data obtained.

• How can we improve communication between and among medical teams, especially the lab, radiology, and the provider who will make the ultimate differential diagnosis?

• Ask local hospitals if they can provide data and expert resources to review certain types of cases and outcomes.

Inpatient vs. outpatient settings Our claims data show that 35% of diagnostic errors occur in physician offices and clinics. It is difficult to determine the exact cause(s) for this finding. It could be that, unlike hospitals, office settings often do not have personnel dedicated to auditing compliance with published practice guidelines. Even if physician offices do review this information, the volume of data may not be large enough to be considered a credible basis for treatment decisions.

• If specific populations are treated, identify barriers to medical regimen adherence and explore opportunities within the community to address barriers.

The emergency department and its role in diagnostic risk The emergency department (ED) and urgent care facilities, as a category, represent the location type with the second-highest incidence of diagnosticrelated claims (24% of claims and 17% of indemnity paid).

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These physicians typically have no ongoing relationship with most patients, some of whom arrive unable to speak for themselves and with no reliable historian accompanying them. ED providers have to make immediate and often lifesaving decisions with little or no information, often with rapid and impersonal patient hand-offs. About 48% of diagnostic-related ED closed claims included allegations of patient evaluation, followed by 26% that alleged issues with ordering tests. More than 50% of diagnostic-related ED claims showed the highest level of severity, a category that includes death. Key risk management issues in order of priority involved clinical decision-making (53%), clinical systems (13%), and communication (8%). Recommendations: • Ensure patient evaluation occurs on an ongoing basis during the ED or urgent care episode by requiring documentation of patient status at prescribed intervals. • Implement clinical decision support tools to assist in the diagnostic process, such as practice guidelines for high-risk presentations, clinical decision applications, and a dedicated radiologist and pharmacist to assist with diagnosis and treatment. • Implement a chain-of-command policy to address situations in which there is a difference of opinion on treatment. Embed that policy into the workflow. • Provide patients with written discharge instructions in layman’s terms that include the diagnosis, treatment provided, symptoms

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that require action and which actions to take, referral information, medications, and other pertinent information. • Develop a protocol to communicate outstanding test results to the patient, primary care provider, and consultants.

Health insurance companies and their impact on diagnosis Our insured providers continue to express concern over health insurers’ approval processes for tests and procedures. They report that the approvals are not consistent, often delay the diagnostic process, and, at times, appear arbitrary. Most practitioners do not quarrel with national practice guidelines for a particular diagnosis if they are supported by credible data, but are frustrated by approvals that require several interim steps that can add complexity and confusion. Recommendations: • Document the patient’s medical record thoroughly regarding discussions, recommendations (include the basis for them and any supporting data or studies), and risks associated with other alternatives. • Scan copies of insurance company denials into the patient medical record and advise the patient to contact the insurance company directly. As the consumer, they may have more influence. • Provide the patient with the option to obtain the test or procedure at their own cost and document the conversation. Diagnostic accuracy to page 344

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PATIENT COMMUNICATIONS

Sharing a life-threatening diagnosis with children Developing best practices BY VAIDA KAZLAUSKAITE, MS, LAMFT; TAI MENDENHALL, PH.D., LMFT; AND KIRBY CLARK, MD

isclosing a cancer diagnosis is likely one of the hardest conversations that a parent ever has to have with their child. Many are unsure about how, when, and how much to tell their children. Worries about inducing fear, anxiety, and sadness in children lead many parents to keep their diagnosis a secret altogether. The following is a summary of what we know from extant (albeit limited) research, alongside a call-to-action for providers and scholars to further develop best practices for this critical life event.

Summary of literature: what do we know? Initially disclosing one’s cancer—or any life-threatening illness—to a child places high psychological distress on parents and families. However, children who are informed about their parents’ disease—and who are able to talk about it openly—evidence lower rates of anxiety and depression. Children report that they want honest communication and straightforward information … from their parents and providers, in written materials, and on the internet.

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It is also important to advance this communication and information sharing in an ongoing way—as a process, not as a singular event. In a parallel manner, expert guidance about how to talk with children about dating, sex, or finances is better when it is not done as a single moment in time (i.e., “the talk”). Parents do better by their kids when they engage in numerous conversations. Gazendam–Donofrio et al. (2009) confirmed this with the Parent-Adolescent Communication Scale (PACS). Clinician and scholar Tina Sellers sums it up: “It is better to have 100 one-minute conversations than it is to have one 100-minute conversation.” Further, when two parents are involved in a child’s life, it is important that both are engaged in diagnosis disclosure processes. Collective, inclusive, familybased conversations benefit both the child and the couple, insofar as dependent variables across both individual (e.g., depressive and anxious symptoms), and dyadic/family (e.g., perceived support, reduced conflict) levels follow.

Critique of literature The principal challenge of developing best practices from this limited literature is exactly that: it is limited. This is evident by the paucity of published studies (in general) and—in the studies that do exist—a lack of theory in guiding scholarship, inconsistencies in methods and analyses, and relatively incomplete and/or imprecise findings. More than half of the articles that we reviewed failed to use a theoretical lens. While theory does not always directly translate to practice, it can aid scholars in operationalizing their topic of interest, articulate the questions that they ask, determine which measures and methods are most appropriate to use, interpret study findings, and inform next steps in the investigations that they advance. Many studies evidence sampling bias, insofar as participant recruitment has only occurred in clinical settings. Patients/families who cannot access or afford regular care and/or those who have chosen not to seek or continue treatment secondary to advanced stages and incurability have not been considered. In addition, most studies to date have focused on mothers with breast cancer—thereby leaving out unique challenges that patients face when living or dying with a myriad of other types of cancer. Finally, inconsistent use of well-established assessment tools raises concerns about the validity and generalizability of what we do know. For example, several researchers have employed the Hospital Anxiety and Depression Scale (HADS) instead of better and more established tools, like the Patient Health Questionnaire-9 (PHQ-9) or the Generalized Anxiety Disorder 7 (GAD-7) assay.

Implications for providers Health care professionals working with families in which a parent is diagnosed with cancer must consider each families’ unique relationships and situation when discussing the process of disclosing the disease to a child. Because talking about cancer is better framed as a process (not as an event), providers should help to create spaces and paths for open communication

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Assessing families’ cohesion, flexibility, and communication is possible through both paper-and-pencil tests (FACES IV) and observational assays (Clinical Rating Scale). Data derived could shed light on how these foci function for parents as they traverse difficult conversations about cancer, its treatment, and its outcomes (generally), and enable us to support the manners in which they do so vis-à-vis unique cultural beliefs around It is also important for parents to give ageillness and dying processes (specifically). For appropriate information to their children. example, the manners in which we support a Younger children (e.g., eight years old or less) family whose cohesion is disengaged, flexibility is do not need as much detail as older children Children report that they want rigid, and communicative facility is low will look honest communication. do. Parents should prepare in advance—with different than the ways we engage with one whose help from their providers—to ensure they can cohesion is enmeshed, flexibility is structured, calmly communicate and answer questions and communicative facility is high. Relatedly, the with confidence. Parents need guidance to find ways in which we support a family that inhabits resources for an age-appropriate vocabulary when a collectivist culture that ascribes to tenets of discussing diagnosis and treatment plans. Parents animalism and ancestral spirits will look different might explain the word “cancer” as “bad cells,” and frame unknowns in a than the ways we engage with one who inhabits an individualist culture and matter-of-fact fashion (e.g., “We don’t know if the treatment will work” or does not believe in an afterlife. “We are not sure how long the treatment will last”), which is better than and trust through disclosure conversations and care/treatment discussions over time. Screening for increased psychosocial distress or decreased mental health should be implemented before and early into the disclosure process. These screenings can be helpful in our efforts to refer parents/families who may need additional support, especially when their needs fall outside of our own scope of practice.

offering idealistic projections (e.g., “We are sure that Mom will be okay”). Focusing communication around guilt reduction, expressing guarded hope, and talking about how the diagnosis will impact family members’ lives can help a child—and others—to cope better. Providers who are guiding parents during disclosure conversations should understand basic developmental levels, and talk with parents before, during, and after early conversations begin.

Conclusion There is little doubt that disclosing a cancer diagnosis is one of the hardest conversations that a parent ever has to have with their child. Providers can support families by equipping parents with knowledge and encouragement to Sharing a life-threatening diagnosis with children to page 324

Professionals from multiple disciplines (e.g., palliative care, hospice, family medicine, and behavioral health) are charged with a duty to offer guidance and support that focuses on effectively communicating a diagnosis of cancer, and to involve children in those conversations. Nurses, medical family therapists, psychologists, and family advocates are well suited to offer this support. Health care teams should employ both medical and mental health providers in integrated care team formats so as to meet and engage with parents and children in a manner customized to their medical literacy.

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A call to action Utilizing theory to frame future studies will serve to advance both a) the new knowledge we gain and b) the support/care that we provide to parents and families who are navigating cancer. For example, the Circumplex Model of Marital and Family Systems, informed by Family Systems Theory, was created by Olson and colleagues (1989, 2000, 2019) to bridge longstanding gaps between research, theory, and practice. The model considers respective levels of families’ cohesion and flexibility, alongside communication as a facilitating dimension of these two continua. Cohesion encompasses the emotional bonds between family members; it is assessed across disengaged, separate, connected, and enmeshed levels. Flexibility relates to families’ capacity to adapt to change; it is assessed across rigid, structured, flexible, and chaotic levels. Communication encompasses family members’ listening and speaking skills, capacities for self-disclosure, clarity, and ability to stay on topic. While caution about making presumptions vis-à-vis cultural/ethnic norms around family functioning is indicated, generally families who are “balanced” in cohesion and flexibility (i.e., in the middle of these continua) do better when faced with developmental and/or situational stress.

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PAIN MEDICINE

Targeted drug delivery Feedback from patients BY DAVID SCHULTZ, MD

ura Pain Clinic manages approximately 650 Minnesota patients who have had a “pain pump” (Medtronic Synchromed II or Flowonix Prometra) implanted and/or re-implanted for Targeted Drug Delivery (TDD) at some time over the past 25 years. We have long believed that opioids targeted to the spinal cord are far preferable to systemic opioids targeted to the brain when treating complex chronic pain that has failed to respond to all other treatments. With the opioid crisis raging across the country, our preference for spinal over systemic opioids has only been reinforced.

A targeted approach TDD with a programmable, continuous infusion pump and spinal catheter is a reversible, non-destructive method for controlling severe chronic pain that moves patients from the “fix it” path of more surgeries and more medical interventions to the “quality of life” path of reduced pain and improved function. Pump medications are targeted to the spinal cord and block pain at the spinal cord level, thus keeping the brain free from drug effects. A typical intrathecal pump infusion in our clinic consists of an opioid mixed

with a local anesthetic. These drug admixtures are continuously infused at low dose into the spinal fluid with the catheter tip placed at the spinal level of maximal pain, blocking regional spinal pain receptors and avoiding brain drug effects of mental clouding, somnolence, and confusion. Although physical dependence may develop with pump opioids and withdrawal may occur if the pump infusion is abruptly stopped, addiction potential is eliminated because there is no euphoria or “high” feeling associated with spinal opioid infusion. Furthermore, for those pump patients with severe physical pain and an addiction history, the physician controls the drugs within the pump and the opioid cannot be abused and/ or diverted by the patient. Interestingly, pain pumps can be effective even without opioid. We have long considered Bupivacaine to be the most important pump medication, and some of our patients have Bupivacaine as their only pump drug. Bupivacaine is a powerful spinal anesthetic with many years of safe experience in the operating room for surgical anesthesia and in the OB suite for labor epidural infusion. Low-dose spinal Bupivacaine blocks pain fibers while leaving the sensory motor nerves unaffected so that patients may function normally. Local anesthetic and opioid are synergistic in the spine, since Bupivacaine blocks nerve conduction whereas spinal opioids bind to spinal opioid receptors.

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During an 18-month period from May 2018 to August 2019, we invited our pump patient population to take an anonymous, 18-question survey assessing satisfaction levels. We asked for feedback on TDD as a pain management option and overall satisfaction with the implanted pain pump using multiple-choice questions with an open-ended comments section for additional observations. The survey was voluntary and anonymous, and patients did not receive any compensation for survey completion. The primary outcomes of this survey were defined as patient satisfaction across three domains: relief of pain, improvement in quality of life, and improvement in physical function. Secondary outcomes evaluated opioid consumption, health care utilization, comfort of the implanted pump, and side effects. Four hundred and forty-three patients (74% of the active pump population) completed the survey. The majority of patients reported improvement in pain, improvement of physical function, improvement in quality of life, and reduction in opioid use. Complete discontinuation of oral opioid intake was reported in approximately 40% of patients. We have recently published our survey results in the peer-reviewed journal Neuromodulation (available at https://tinyurl.com/mp-tdd-survey). Survey respondents were 28 to 94 years old, and 60% were female. The most common indication for pump implant was low back pain with post-surgical spine syndrome (ICD-10 M96.1). Other common diagnoses included chronic abdominal pain, atypical facial pain, post-herpetic neuralgia, intractable neck pain, and cancer-associated pain. Many of our

patients had substantial comorbidities, including obesity, hypertension, diabetes, and chronic obstructive pulmonary disease. Some patients had multiple comorbidities.

Improvements in pain, physical function, and quality of life Overall, 96% of surveyed patients reported benefit from pump implantation (328/342), with 78% of patients reporting moderate to strong benefit (265/342). Similarly, pain relief was evident, with 94% of patients reporting improved pain control following pump implantation (398/422) and 59% of patients stating their pump provides good to excellent pain relief (249/422). Only 6% (24/422) of patients reported worsened control of chronic pain following pump implantation. Importantly, 78% (318/410) of patients stated they had improved physical functioning after TDD. Only 3% reported worse functioning after pump implant (14/410). Overall, 87% (357/413) of patients responded that pump implantation improved their quality of life compared to preimplantation. Only 9/414 (2%) reported worsened quality of life following pump implantation.

respondents stated that they had not gone to the ER or hospital for pain since their pain pump was implanted, and another 15% reported going less often than before. Seven percent said they go to the ER/hospital about as often as before, and only 1% of respondents said they went to the ER/ hospital more often after the pump implant than before.

Opioid consumption Post-implant, 88% of survey responders reported taking less oral opioid medication and 39% of patients stated they had completely stopped oral and transdermal opioid intake. Other published studies have assessed decrease in oral opioid use by measurements of changes in dose consumed, percentage of patients non-reliant on oral opioids, and scoring scales of medication Targeted drug delivery to page 304

Opioid consumption With regard to continued oral and transdermal opioid intake, 89% of survey responders reported taking less oral opioid medication than before pump implantation. No pump patients were taking transdermal or long-acting oral opioids after implant. Nearly 40% of patients stated they had completely stopped all opioid intake and relied solely on TDD for pain control.

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Side effects Patient-reported side effects were also diminished following pump implantation. Seventy-two percent of patients reported being more mentally alert. More than half of patients reported having no side effects (56%) from TDD and, overall, 94% reported no or manageable side effects. Of those patients with side effects, constipation was the most common. Ten years of Medtronicâ&#x20AC;&#x2122;s Product Surveillance Registry (PSR) data shows that the most common adverse events were untoward drug reactions and that serious adverse events were rare and usually involved device-related infections. Rate of infection after pump implant at Nura is less than 0.5%.

Pump and catheter location Our approach has always been to place the catheter tip at the site of maximal pain. Catheter tip locations ranged from spinal level C1 for head and face pain, down to T12 for pain in lower extremities. We have seen no increased incidence of side effects or complications related to placement of catheter tips at cervical spinal levels.

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Pump discomfort and pocket-site pain were additional concerns we addressed. The pump was implanted in the upper buttock in 76% (314/411) of patients and in the abdomen in 15% (60/411), and a majority of patients had the larger 40cc pump size. Upper buttock pump implant allows for prone positioning and decreased surgery times with very low infection rates. The pump was reported as comfortable by 92% of respondents. Regardless of buttock or abdomen pump pocket, 91% of patients were happy with the location of their pump.

Health care utilization In terms of health care utilization, the majority of patients selected for TDD trial had visited the emergency room or been admitted to the hospital for pain relief in the year prior to pump implant. After implant, 77% of survey

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PROFESSIONAL LIABILITY

Medical directorships Due diligence prior to accepting an offer BY ANTONIO “TONY” FRICANO, JD

he licensure requirement to practice medicine acts as an entry barrier to prevent individuals from performing tasks that our regulators deem to require a certain level of knowledge, skill, and medical training. While some business-minded individuals and entrepreneurs in nonclinical settings might see this requirement simply as a box that needs to be checked, it is more than that. This issue has been a serious one in the medical spa industry for some time, and it will take on added significance in the coming year within the assisted living space as the focus on clinical services in facilities expands. The scenarios usually play out with an unlicensed business owner who seems very knowledgeable and experienced approaching a physician with an offer to become the medical director for an attractive salary and without a significant time commitment. Sometimes this medical director role will not result in negative consequences, but there are certainly times where these situations do not turn out well for physicians. Unfortunately, many physicians who have not yet experienced a compliance issue may find it hard to see the potential for negative consequences—including potential disciplinary actions. This article will provide physicians with a roadmap of

SUNFLOWER SPREAD

the minimum fundamental inquiries they need to make prior to accepting a medical directorship with certain facilities.

What are the risks and why should you care? The risks involved in a medical directorship derive from the duties that a physician takes on by assuming such a position. Some of those duties are set forth in the terms of the directorship agreement, some are required by law, and others can be implied. When there is a breach of those duties, the consequences can involve civil liability and discipline by the medical board and state and local regulators. Below are some of the common duties associated with a medical directorship: • Establishing proper clinical protocols for treatment and delegation of services; • Supervising clinicians and staff; • Establishing staffing requirements and the credentialing processes; • Ensuring compliance with Medicare, Medicaid, and commercial payor requirements; and • Establishing staff training programs. Because these obligations are so common, they are often implied regardless of whether they are explicitly included within the services description in a medical director agreement. With respect to civil liability, it is hard to conceive of a negligent act at a facility that cannot be argued to have a causal connection with one of these obligations. With respect to regulatory enforcement, in my personal legal practice—however anecdotal—I have seen an uptick in enforcement activity from the Minnesota Attorney General’s Office, along with an increased focus by the Minnesota Board of Medical Practice on this issue.

Nursing homes and the Minnesota assisted living law Nursing homes are specifically required to hire a medical director that is responsible for development and implementation of resident care policies and procedures, coordination of care, monitoring of staff health, and certain obligations on the quality assessment and assurance committee. The responsibility attendant to those duties is significant and not something that should be taken lightly.

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The new Minnesota law requiring licensure for assisted living facilities will take effect Aug. 1, 2021, and, while it does not explicitly require assisted living facilities to hire medical directors, there are going to be many new requirements which will make it more common for facilities to do so. Many of the requirements will be similar to those applicable to the home care agencies that previously provided services at these facilities, but there will be differences, as the combination of requirements previously applicable to the facility and the home care provider agency converge. Because these Minnesota requirements are new, there is not a situation where an unlicensed individual can approach a physician about taking on a medical directorship and honestly claim that they have sufficient experience to allow minimal involvement from the physician. No individual in

Minnesota has previously operated under these regulations, so compliance will require work for all facilities. Further adding to the risk in this area is the fact that senior care facilities have been a major point of legislative action over recent years, and we can expect that there will be substantial enforcement in this area. The populations at these facilities are vulnerable, and small missteps can result in significant adverse health events.

to be the practice of medicine. As such, the legal entity that provides the medical service must be owned by a physician, and the medical procedures must all be performed within the scope of delegation and supervision permitted by the Minnesota Board of Medical Practice.

Entrepreneurs that recognize the need for a licensed individual to be associated with their medical spa will engage physicians to fill this role, but problems can arise if they don’t know the level of involvement required by physicians When you agree to be a medical The medical spa industry or if they don’t want to commit the required director for a noncompliant While the patient population is quite different, organization, you risk resources for the required level of physician contracting with medical spas—which may aiding and abetting. involvement. When considering whether to provide medical cosmetic services, including accept a medical directorship for a medical spa, Botox injections—involves many of the same a physician should first inquire about how it issues a physician should consider as when is organized. As previously noted, a compliant contracting with an assisted living facility (e.g., structure requires that the actual medical spa be can the physician dedicate the necessary time, owned by a physician, while investors that are non-physicians will typically and does the physician have adequate expertise). However, there are some form a management company that will supply the medical spa with all nonunique risks when contracting with medical spas that should be evaluated medical services and administrative personnel. This is an important—yet as part of the physician’s due diligence process prior to accepting a position not always obvious—distinction, as many times the investors consider as medical director. themselves the “owner” and many in the industry do not have compliant Specifically, given the nature of medical spa services, it is quite common structures. Notwithstanding that others may be noncompliant, when you for estheticians or other individuals who do not have a medical license to be agree to be a medical director for a noncompliant organization, you risk the driving force behind these businesses. The issue with that dynamic is that a significant portion of services provided at medical spas are considered Medical directorships to page 254

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BEHAVIORAL HEALTH

Addressing patient stress during a pandemic How physicians can help BY TODD ARCHBOLD, LSW, MBA

inding ways to balance the physical risks and emotional distress caused by COVID-19 is important for both health care personnel and patients. The mental health needs of entire communities are on the rise. The best practices that we are promoting to keep people safe from the virus are completely contrary to the practices we rely on to stay mentally well and emotionally resilient. “Social distancing,” the pillar of these efforts, has led to fear and isolation for many people. The reality is that COVID-19 is not a “social” disease at all, since it is transmitted by respiratory droplets among individuals who may have never had any social interaction. The inadvertent side effect of trying to keep physically safe through social distancing has in fact created emotional distress and removed us from the usual comforts of life and means of support. These necessary measures are our best defense in fighting infectious diseases, but many patients are now reporting an increase in emotional distress as a result. Health care providers around the world are now tasked with providing exams and treatments to patients who are fearful of clinics and hospitals. In addition, the added stress of dealing with this pandemic is interfering with preventative visits, and the costs of care for patients dealing with comorbid

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conditions will likely increase even more. The challenge for our health systems and clinicians will be to provide necessary care while addressing the added complexity of the impact to the mental health of patients and providers alike.

Keeping physically safe We need to begin by encouraging patients to prioritize basic efforts to stay physically safe from contracting coronavirus, especially those with chronic health conditions, older people, or those with multiple health conditions or weakened immune systems. Luckily, most health systems now have the necessary telehealth infrastructure to deliver basic care and education remotely. The goal is to help patients adopt habits that simply eliminate or avoid situations in which they may encounter the virus. These efforts have been prominent around the globe since the start of this year, initially with diligent handwashing, avoiding physical contact with others, and staying away from crowded areas. These practices have been forcefully encouraged under government shutdowns of nonessential businesses and covered extensively in the media. They become far more credible when they are reinforced by one’s physician or care provider. Patients can be reminded that individual hygiene is critical, as are public efforts such as our socially acceptable 6-foot physical distance from others and wearing facemasks when outside of the home. Many vulnerable patients, or those with high anxiety, can find additional comfort in formal efforts such as shelter-in-place that enforce these behaviors. Businesses are also making great efforts to keep us safe through heightened sanitation/cleaning protocols, barriers at retail counters, and visual reminders about distancing. When individuals feel more comfortable in these physical precautions, they are less likely to be socially isolated. They can more freely shop for essential items such as groceries. They will be more apt to go on walks outside, visit parks and trails, and even attend a small backyard event. Interestingly, early trends show that extroverted individuals are coping with reduced social interactions better than introverted individuals. Extroverts tend to capture energy and emotional input through more brief interactions, such as small talk (even via online and social media), while introverts tend to be more emotionally fulfilled through longer and more steady social input— which has proven difficult in these times of brief and distant interactions. Spending extra time with patients can help them take control of their own behaviors to keep themselves and those around them safe. This is empowering for many patients, and it provides a greater sense of control over the situation, helping them avoid feeling helpless. During times of helplessness, mental health clinicians have long encouraged individuals to “control what you can.”

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This unprecedented pandemic-related stress adds barriers to receiving health care, including mental health care. According to a poll conducted by the American Psychiatric Association in late March, “more than one-third

of Americans (36%) say coronavirus is having a serious impact on their mental health and most (59%) feel coronavirus is having a serious impact on their day-to-day lives. Most adults are concerned that the coronavirus will have a serious negative impact on their finances (57%) and almost half are worried about running out of food, medicine, and/or supplies. Two-thirds of Americans (68%) fear that the coronavirus will have a long-lasting impact on the economy.â&#x20AC;?

through the use of telehealth. PrairieCare Medical Group experienced an initial dip in patient visits at the onset of the pandemic, but now, as a result of the increased efficiencies of telehealth, is able to offer a greater number of appointments with more flexibility. Many individuals who may have been more predisposed to an illness, especially anxiety disorders and depression, may now be experiencing diagnosable symptoms, due to the pandemic, that warrant mental health treatment. In addition, many individuals struggling with job loss, social isolation, financial distress, and more may be experiencing general stress-related conditions such as an adjustment disorder, alcohol/drug use disorder, or post-traumatic stress disorder (PTSD).

Most healthy individuals receive emotional support from their family, peer groups, and social Social distancing ... has led to fear and isolation for many people. circles, which are physically distanced and, at best, moved online. Many individuals are fearful to visit clinics, and especially hospitals, for fear of contracting coronavirus. Most health care systems have quickly adopted telehealth for these patients. In general, kids will be far more resilient to PrairieCare Medical Group, one of the regionâ&#x20AC;&#x2122;s the impact of this pandemic on their mental largest providers of psychiatric health care, now provides close to 80% of health than adults, who will struggle with profound feelings of self-worth, visits by telehealth, including group therapies. Patients feel much safer not insecurity (exacerbated by job loss, feeling out of control, helplessness, etc.), having to leave their home for care. While not all psychiatric services can and existential angst. Basic screening tools such as the PHQ-9 (depression), be done using telehealth, this method of care delivery will help thousands GAD-7 (anxiety), and the AUDIT (alcohol use) can quickly identify a remain connected to their supportive services. When patients experience potential diagnosis and then help refer a patient to a mental health clinician. a psychiatric crisis, such as panic attacks, a suicide attempt, or a drug All of these tools are easy to administer and can be found free online. A overdose, they most often end up in a hospital or emergency room. referral to a mental health clinician will prevent worsening of symptoms as Many patients struggling with a previously diagnosed mental illness have likely been able to retain access to their psychiatrist or therapist

Addressing patient stress during a pandemic to page 244

MINNESOTA PHYSICIAN MAY 2020

3Addressing patient stress during a pandemic from page 23 we continue to endure this pandemic and avoid the need for higher levels of care, including the need for hospitalization, if symptoms go unattended. Some of the more serious warning signs of mental illness are irritability, becoming withdrawn, outbursts, and thoughts of harming oneself. If patients express any of these signs, they should be referred immediately to a mental health clinician.

Looking ahead

It is critical to care for both the physical and emotional needs of our patients during this tough time, and also to look ahead to the future. As experts in health care, the way that we message information about dealing with this pandemic is important. When we convey positivity, our patients and communities respond accordingly. Helping our patients have a sense of agency when things seem More than one-third of Americans out of control will build resiliency. (36%) say coronavirus is

During routine check-ups, physicians should having a serious impact also ask about the impact of some of the smaller Many people are dubbing the current state on their mental health. disruptions to one’s daily routine, marked by as the “new normal,” which can be misleading, changes in behavior, sleep, diet, and general since this state is merely temporary, and far from activity levels. These subtle changes can add up normal. If a marathon runner develops blisters quickly and lead to mental and emotional distress. on mile 20, rationalizing the discomfort as a new Even minimal disruptions of circadian rhythms normal may help them cope until they reach the can have a drastic impact on the quality of restorative sleep, health, and finish line, since blisters are only temporary and will heal. Don’t confuse well-being. As more of us adapt to working from home, helping kids with this current state of discomfort as the future state; this is merely a phase we distance learning, having groceries delivered, and cancelling weekly social are experiencing on a journey to a brighter, more resilient future. Sharing events, our rhythms are unwittingly impacted, leading to symptoms such positivity and tending to both physical and emotional needs helps to refuel as headaches, fatigue, and irritability, and all the way up to more serious ourselves and those around us for the ongoing journey of life. conditions such as weakened immune system functioning, insomnia, depression, mania, and more. The compounding effect of these disruptions Todd Archbold, LSW, MBA, is a licensed social worker and the chief to our daily lives can manifest as noticeable stress. Over time, and without executive officer at PrairieCare. proper intervention or rationalization, this will lead to mental illness.

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3Medical directorships from page 25 aiding and abetting the unlicensed practice of medicine in violation of the Minnesota Medical Practice Act. Even if the corporate structure is compliant, that is really only a foundational aspect of what should be considered. More importantly, from the patient care perspective, is the question of whether you have expertise in the areas sufficient to supervise and delegate operations to others and whether you will devote the required amount of time to ensuring proper operations and medical treatment. The fact that non-licensed proprietors have experience with the medical spa treatments often provides a false sense of security and increases the risk in these relationships.

Absolute minimum due diligence Below are some recommendations that I would categorize as the minimum due diligence a physician should consider prior to accepting a medical directorship in either the senior care or medical spa industries: • Review the arrangement for compliance with corporate practice of medicine laws. • Ensure that the arrangement does not involve the illegal splitting of fees or aiding the unlicensed practice of medicine. • Assess whether you have the requisite skill and experience to be a medical director in the practice area.

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• Do you have the time to provide the necessary level of services?

• Does the contract allow you to work enough hours to provide the appropriate level of services? • Is the facility properly staffed? If not, will you have the ability to change that? • Does your malpractice carrier cover your work as a medical director? • Does the arrangement comply with the state and federal fraud and abuse laws? These considerations are high level, and there are numerous additional inquires that should be looked at depending on the nature of the arrangement. In some circumstances, a medical director agreement is relatively straightforward and standardized, but in other situations (such as in the senior care and medical spa industries), they present an increased level of risk and will benefit from review by a health care attorney. The good news is that most attorneys will review medical director agreements on an hourly basis, so the charge for review should correspond to the risk and complexity of issues involved. 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 on physician employment and services agreements. Prior to starting with Lathrop GPM, Tony was an attorney at the largest health system in Illinois.

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PUBLIC HEALTH

Health care facility design Lessons learned from the pandemic

BY MIKE MCMAHAN AND ALENA SAKALOUSKI JOHNSON, AIA, ACHA

ultiple factors, including internal dynamics and outside forces, have in recent years created a tipping point in the health care industry. The Affordable Care Act, private equity, tax reform, payer disruptions, new health care industry entrants, and skilled worker shortages have created new challenges for health organizations across the United States. COVID-19 now poses a unique challenge to the health care industry. Changes in how patients seek care, care avoidance, and the move toward a more value-based model have impacted how physical environments look and function. This in turn has caused the need for health systems, hospitals, and provider groups to quickly rethink their facilities to provide both the capacity for innovation and social distancing considerations with the flexibility to foster an uncompromised level of patient care and financial sustainability. Recent experiences in managing the COVID-19 pandemic have emphasized the role of unified data in evaluating levels of readiness and formulating rapid response in the health care environment. The regulatory answer to the pandemic is certain to require that health care facilities adopt

current and evolving best practices to ensure flexibility, adaptability, and heightened infection prevention measures in all patient care spaces. Health care leaders everywhere are learning to synthesize data from all available sources to inform decisions that literally save lives in their community. The stakes could not be higher, nor the need greater, for data-informed decisions, efficient design, and strong leadership.

How data shaped early decision-making Minnesota is fortunate to have a strong regional system of health care organizations and influential research institutions like Mayo Clinic and the University of Minnesota, and this, along with existing data-sharing practices, has provided a solid platform for emergency response. The Governor’s office assembled a group of multidisciplinary experts from organizations across the state, including leaders representing the Minnesota Department of Health (MDH), State Health Care Coordination Center, Minnesota Hospital Association (MHA), and the University of Minnesota, to convene a statewide Minnesota COVID Ethics Collaborative. This group has worked closely and at regular intervals to research emerging state-wide data and react on behalf of the health care community across the state. Minnesota relies on capacity modeling and infection tracking data from MDH and MHA, using testing data to evaluate what hospitals will need in terms of ventilators, PPE, beds, and staffing, forewarning systems of potential shortages in these vital resources. Health care leaders know this type of actionable data—like what can be found in MDH’s’s MNTrac application—helps project demand and identifies where resources can be effectively deployed to match that demand. Whether it’s tracking change over time, or during a specific event like the COVID-19 pandemic, local data is your most actionable intelligence, yet it’s wise to pay attention to data trajectories from other states and regions, as we have learned it could impact the PPE and medical equipment supply chain, and it can help shed light on what to expect in different phases of the virus.

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For example, population density is a known major factor in how fast a virus spreads, with rolling disparity between city, suburban, and rural communities. The comprehensive data collected allows the Centers for Disease Control and Prevention (CDC) to create patterns of spread, demographic data, and a wide swath of information that can inform health care organizations in order to prepare. Ultimately, this situation was like many other crisis response scenarios, although much larger, using all available data to plan for the worst while hoping for the best.

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Flexible design to meet a changing landscape It will now be more important than ever to incorporate flexibility and adaptability into the design of both inpatient and outpatient care environments. We do not yet know what the future may hold, but we have begun to identify a few areas where design response must be either immediate or incorporated in the short term:

we must at least have a plan for surge capacity. This includes examining Invest in technology. As a result of the COVID-19 pandemic, a more how existing hospital space can accommodate a significant increase in the prominent reliance on telehealth services will impact how future space is number of patients and ensure the safe flow of supplies and materials in planned in care environments. In March 2020, the Centers for Medicare the face of higher equipment loads and an increased need for negatively and Medicaid Services (CMS) broadened reimbursements for virtual care, pressured patient care areas. This may also include accelerating the shift to this growing method of looking at how outpatient facilities can flex to providing care. The change has enabled more be able to accommodate patient surges, by both providers to consider this in their care toolkit, and more systems have moved to implement utilizing existing environments and incorporating the technology needed for its support. From a this flexibility in the design of all future spaces. facilities perspective, the potential impact may be Ultimately, each health care system will need to Plan for the worst while a decreased reliance on physical space, since many formulate and implement a comprehensive plan. hoping for the best. providers will be able to practice from their homes. Leverage data to create strategy for the Rethink waiting rooms. Social distancing is here to stay, and as we are beginning to reopen clinics and ambulatory care facilities, we must rethink how and where the health care customer is waiting to be seen. Potential immediate solutions may include spacing out furniture, staggering appointment times (which likely will extend operating hours), or replacing a physical waiting room with a “virtual” one in which a patient waits in their vehicle before receiving virtual notification that their care provider is ready to see them.

future. In addition to having an action plan at the ready in the event of another pandemic, health care systems and provider groups need to strategically examine their current and future investments. The health care economy that will emerge from COVID-19 will permit even less margin for underperforming sites, requiring analysis and decision-making that thoughtfully and thoroughly considers emerging future reimbursement models, trending demographics, the likely availability of staffing resources, and ultimately the urgent and evolving needs of the communities we serve.

Plan for surge capacity in both inpatient and outpatient facilities. Although designing hospitals to be able to accommodate a 100-year blackswan event is arguably like “designing a church for Easter Sunday” (both impractical and cost-prohibitive), the COVID-19 pandemic taught us that

Effective leadership during times of crisis During crisis, leaders are often making decisions under a whole new set Health care facility design to page 284

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3Health care facility design from page 27 of priorities, particularly when changes happen quickly, and with new data being made available every day. We’ve seen, through the COVID-19 pandemic, different outcomes based on decisions made by leaders—from the government to health care organizations. Because situations and relationships are fluid and complex, there’s no one right way to lead, but some best practices can be observed. One important consideration is to not put too much trust into your own bubble and instead, look beyond your own personal experience. Listen and learn from those around you (nations and worldwide, too) and take in as much data as you can to make the best-informed decision possible in the moment. Sometimes you must simply decide with the information you have and in which you are confident. In many situations, time is an extremely important variable. Leaders who earn respect are the ones who transparently share data, providing valuable perspective to their teams and collaborators. There is immutable strength in saying there’s nothing to hide. Share as much and as often as you can, and share information when you feel confident about it; you’ll give others confidence and earn their confidence in your leadership. Data is not the only factor in every leadership decision, as some choices more simply come down to doing the right thing. These can still be extremely difficult decisions, literally of life and death, but if your convictions are grounded in both data and integrity, you can own that decision—and sell it, too. Stand by informed, compassionate decisions and people will stand by you.

Finally, remember that personal connections are reliable resources; relationships nurtured in good times get leaders through tough times. Similarly, leaders who consistently engage their staff throughout less turbulent times can also be more effective leaders through times of crisis, with difficult conversations and transparency made easier from practice, open communication, and steady relationships.

Looking ahead The next crisis may look nothing like this one, and all the data or design planning in the world may be irrelevant to certain new circumstances. It’s often said that the only constant in life is change, but it is proven that good leadership is always a strong foundation in which to help navigate that change and empower future leaders to do the same. Mike McMahan is Senior Vice President of Healthcare at Ryan Companies US, Inc. Mike leads a team of experts on healthcare real estate and facilities and, as a part of the state’s response to the COVID-19 pandemic, served as a Healthcare Executive Liaison for the State Health Care Coordinating Center (SHCCC) within the State Emergency Operations Command Center.

Alena Sakalouski Johnson, AIA, ACHA, is a board-certified healthcare architect at Ryan A+E, working within a multi-disciplinary team to address the changing healthcare landscape.

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3Targeted drug delivery from page 19 â&#x20AC;&#x153;This was my last resort to 10 years of going through everything possible to consumption. Throughout all these different measurements, decreases trying to control my pain. The pump saved my life, literally. It is my miracle in in oral opioid use were observed following TDD therapy, with one study life. Thank you.â&#x20AC;? showing a 92% rate of elimination of oral opioid Conclusion use over a 5-year follow-up period (Caraway et. Al, Targeted Drug Delivery with a pain pump is a Neuromodulation 2015). Another study following drastic treatment, and we do not consider TDD as long-term effects of oral opioid use in patients with an option unless the patient has severe, intractable intrathecal TDD therapy showed a reduction in pain that has failed to respond to all other Opioids targeted to the spinal oral opioid use over the follow-up period (Herring treatments, including medication management, cord are far preferable to systemic et. Al. Pain Med 2019). spinal injections, surgeries (if indicated), and trials opioids targeted to the brain. In their own words of neurostimulation. Nonetheless, I believe that As an interventional pain doctor for the past TDD is the very best treatment we have to offer 30 years, I have often asked my patients what for those patients whose only recourse would be to treatment has worked best for them. Patients are live a life on high-dose oral or skin patch opioids. often grateful for pain-relieving procedures such as spinal injections and nerve ablations, but I have always been struck by David Schultz, MD, is the medical director and founder of Nura pain comments from my pain pump patients who often tell me the pump was the clinics. Dr. Schultz is a board-certified anesthesiologist with additional board best thing they ever did and that they could not imagine living without it. certification in pain medicine from the American Board of Anesthesiology, We do not often hear comments like that from pain patients in regard to any the American Board of Interventional Pain Physicians, and the American other therapy. At the end of our survey, we asked patients to tell us anything Board of Pain Medicine. He has been a full-time interventional pain specialist else about their pain pump that they thought was important and the intense since 1995. emotional connection that many patients have to their implanted pump came across loud and clear. Although a few of our pump patients made negative comments, we were inundated with positive comments such as:

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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.

Physician/employer direct contracting

CAR T-cell therapy involves drawing blood from patients and separating out the T cells. Using a disarmed virus, the patient’s own T cells are genetically engineered to produce chimeric antigen receptors, or CARs, that allow them to recognize and attach to a specific protein, or antigen, on tumor cells. This process takes place in a laboratory and takes about 14 days. After receiving the modification, the engineered CAR-T cells are infused into the patient, where they recognize and attack cancer cells. Kymriah received initial FDA approval in 2017 for the treatment of pediatric acute lymphoblastic leukemia.

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.

CAR T-cell therapy to page 144

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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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3Sharing a life-threatening diagnosis with children from page 17 Journal of Family Theory & Review (2019). “Circumplex model of talk openly with their kids early in the illness journey—and to continue talking marital and family systems: An update”: https://tinyurl.com/mp-jftr2. along the way in a manner that is compassionate, open, and matter-of-fact. Moving beyond these baseline understandings, Vaida Kazlauskaite, MS, LAMFT, is a doctoral more research is needed to inform—and assess— candidate at the University of Minnesota in the best practices in the manner(s) that we employ to Department of Family Social Science. Her primary guide parents through this challenge. Attention to clinical and research interests focus on advancing families’ general functioning across interpersonal Talking about cancer is supportive methods to assist families in navigating cohesion, flexibility, and communication will be better framed as a process cancer diagnoses and treatment. helpful, paired with careful considerations related (not as an event). to cultural mores, ethnic traditions, and faithbased belief systems. Tai Mendenhall, PhD, LMFT, is a faculty member at the University of Minnesota in the Department of

To read the full critical review upon which this article is based, contact Vaida Kazlauskaite at kazla007@umn.edu.

Family Social Science. His primary interests focus on community-based participatory research to support

Additional reading

families as they cope with chronic illnesses.

American Cancer Society (2016). “How to tell a child that a parent has cancer”: https://tinyurl.com/mp-am-cancer-society.

Kirby Clark, MD, is a faculty member at the University of Minnesota St.

National Comprehensive Cancer Network (2020). “How to tell your children about your cancer diagnosis”: https://tinyurl.com/mp-nccn2.

Physician Associate Programs of the University of Minnesota Medical School.

John’s Hospital Family Medicine Residency and Director of the Rural and Metro

ACS Journals: Cancer (2009). “Parent-child communication patterns during the first year after a parent’s cancer diagnosis”: https://tinyurl.com/ mp-acs-journals.

Carris Health

is the perfect match

Carris Health is a multi-specialty health network located in west central and southwest Minnesota and is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. CURRENT OPPORTUNITIES AVAILABLE FOR BE/BC PHYSICIANS IN THE FOLLOWING SPECIALTIES: • • • • • •

Anesthesiology Dermatology ENT Family Medicine Gastroenterology General Surgery

• • • • • •

Hospitalist Internal Medicine Nephrology Neurology OB/GYN Oncology

Loan repayment assistance available.

FOR MORE INFORMATION: Dr. Leah Schammel, Carris Health Physician

MAY 2020 MINNESOTA PHYSICIAN

Shana Zahrbock, Physician Recruitment Shana.Zahrbock@carrishealth.com (320) 231-6353 | carrishealth.com

• • • •

Orthopedic Surgery Psychiatry Psychology Pulmonary/ Critical Care • Rheumatology • Urology

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

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. 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:

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

Apply online at www.mankatoclinic.com

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

•

www.minneapolis.va.gov MINNESOTA PHYSICIAN MAY 2020

3Diagnostic accuracy from page 15 • Track repeated denials for the same request. Ask for an evidencebased rationale. Send any evidence you have that supports approving the test or procedure that was denied.

Final recommendations The following recommendations apply broadly to the phenomena of diagnostic errors: • Honestly examine diagnostic culture and other influences that create overconfidence in medical diagnoses. • Document any uncertainty in the EHR to alert other team members that the final diagnosis is evolving. This could potentially prevent subsequent providers from becoming anchored in a diagnosis that is less than certain. • Include the patient in the decision-making that leads to a differential diagnosis. Position your assessment as a “working diagnosis” and encourage them to actively examine test results and other information. When something does go wrong, a patient who feels cared for, engaged, and honestly communicated with is less likely to pursue litigation. • Keep your location in mind. Reaching an accurate and timely differential diagnosis in the emergency department may require different processes, skills, and talents than doing so in an outpatient setting. • Use available technology and decision-support tools.

• Be conscious of all that is working against you. There are financial incentives for not continuing to look for the right diagnosis—the hunt can be expensive and arduous. And patients are prone to diagnosis fatigue and can eventually give up, accepting their health challenges as their “new normal.” Encourage patients to come back if they aren’t getting better, to ask more questions, and to share more details and hunches about their symptoms.

Conclusion The magnitude of responsibility for diagnosis is staggering, and the issue of diagnostic inaccuracy is no small matter. Diagnostic inaccuracies may have grave results, but it’s important to acknowledge that doctors are getting it right more often than not. This article includes general risk management guidelines for information purposes. It is not intended, and should not be taken, as legal or medical advice. Robert Hanscom, JD, is vice president of business analytics at Coverys. Maryann Small, MBA, is director of data governance and business analytics at Coverys.

Ann Lambrecht, RN, BSN, JD, FASHRM, is senior risk specialist at Coverys. Publisher’s note: This article is an excerpt from a Coverys report. Unless otherwise indicated, statistics and information are based on Coverys’ analysis of 10,168 closed malpractice claims across a five-year period (2013-2017). A more full report on diagnostic accuracy from the authors, with extensive supporting data, is at https://tinyurl.com/mp-coverys.

Three patients. Who is at risk for diabetes?

When there are no signs or symptoms, you may not know until it’s too late. Act now. Screen your patients for type 2 diabetes. It’s easy. It’s covered. It will reduce their risk. • Refer your at-risk patients to a proven lifestyle change program and help cut their risk of developing type 2 diabetes in half.

1 in 3 adults are at risk!

• For patients who already have diabetes, send them to a quality diabetes self-management program to improve control and reduce complications. Find groups in Minnesota at www.health.mn.gov/diabetes/programs

Minnesota Department of Health DIABETES PROGRAM

MAY 2020 MINNESOTA PHYSICIAN

PAT I E N T C A R E QUALITY OUTCOMES

FOCUS ON WHAT MATTERS MOST WITH COVERYS. Quality outcomes for better patient care are more easily achieved when distractions are reduced. At Coverys, we illuminate unforeseen risks so you can focus on patient satisfaction and reduce exposure to malpractice claims. As a premier provider of medical liability insurance, Coverys’ data insights and risk recommendations will help you provide optimal healthcare outcomes that you can see clearly. Very clearly. Visit Coverys.com for more information or call 800.225.6168.

M e d ic a l L ia b ilit y I n su ra nc e • B us i ne s s A na l y ti c s • R i s k Ma na g e me n t • E d u cat i on COPYRIGHTED. Insurance products issued by ProSelect® Insurance Company and Preferred Professional Insurance Company®

MINNESOTA PHYSICIAN MAY 2020

Holly Boyer, MD

TRANSFORMING HEALTH & MEDICINE Leaders • Educators • Innovators

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