Minnesota Physician May 2019 by Minnesota Physician Publishing

MINNESOTA

MAY 2019

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXIII, No. 02

Evidence synthesis Improving outcomes, avoiding waste BY TIMOTHY WILT, MD, MPH; WEI (DENISE) DUAN-PORTER, MD, PHD; AND NANCY GREER, PHD

he amount of information available to make health care decisions is enormous and changing rapidly. Clinicians, health systems, policy makers, researchers, and patients often find it difficult to identify the “right information” about the effects of health care interventions. These medical information “end-users” increasingly rely on systematic reviews and corresponding clinical guidelines to provide trusted health care information.

Change management Improving outcomes in health care

Evidence synthesis to page 84

BY CLAIRE S. NEELY, MD, FAAP; AND SARAH HORST, MA

For more than 20 years, clinicians and researchers at the Minneapolis VA Evidence-based Synthesis Program (ESP) and other evidence synthesis teams at the VA and the University of Minnesota have conducted and disseminated systematic reviews of health care interventions for high priority clinical topics. In this article, we describe our Minneapolis VA ESP processes and products, highlight examples of recent and ongoing

“People are entitled to joy in work.”—W. Edwards Deming

n health care, where change management is often viewed with dread rather than enthusiasm, this might seem like a surprising way to begin. Change management is most often defined as the process, tools, and techniques required to achieve a certain business outcome. This includes supporting people to make changes. Yet for many reasons, change management in health care—perhaps in the areas of new clinical guidelines, evidence-based practices to integrate behavioral health and collaborative care, implementation of Triple Aim objectives, or staffing structures—often fails to Change management to page 64

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ND 52 SESSION

MAY 2019

Volume XXXIII, Number 2

COVER FEATURES Change management

Evidence synthesis

By Claire S. Neely, MD, FAAP; and Sarah Horst, MA

By Timothy Wilt, MD, MPH; Wei (Denise) Duan-Porter, MD, PhD; and Nancy Greer, PhD

Improving outcomes in health care

Improving outcomes, avoiding waste

DEPARTMENTS INTERVIEW

A trusted voice to create positive change Rose Roach Minnesota Nurses Association (MNA

TECHNOLOGY 12 Social engineering Is your practice prepared? By Ginny Adams, RN, BSN, MPH, CPHRM

MEDICINE AND THE LAW 14 “Stark” legislation and regulation Updating the updates By Antonio “Tony” Fricano, JD

PHYSICIAN-PATIENT COMMUNICATION 16 Surviving a stroke Lessons learned from being a patient By Michelle D. Sherman, PhD, LP, ABPP; and LuAnn Kibira, APRN, NP

PEDIATRICS 18 The Minnesota NET-Works program By Simone A. French, PhD; Nancy E. Sherwood, PhD; and Sara Veblen-Mortenson, MSW, MPH

BEHAVIORAL HEALTH 20 Opioid prescribing A new provider toolkit By Andrew R. Zinkel, MD, MBA, FACEP, FAAEM, and Patty Graham

MINNESOTA HEALTH CARE ROUNDTABLE Consolidation in Health care 24 Examining cost and quality issues

This flip book edition contains our annual Community Caregivers feature recognizing the volunteer work of Minnesota physicians, our yearly Architecture Honor Roll recognizing outstanding new achievements in clinic and hospital design, and the report from a recent session of the Minnesota Health Care Roundtable. This expanded format was the best option to accommodate the additional special focus content.

www.MPPUB.COM PUBLISHER

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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 mpp@mppub.com; phone 612.728.8600; fax 612.728.8601. 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.

CLINICAL AND NON-CLINICAL CARE TEAMS Improving interoperability

Thursday, November 14, 2019, 1–4 p.m. The Gallery, Hilton Minneapolis | 1001 Marquette Avenue South BACKGROUND AND FOCUS:

As health care costs constantly rise, containment strategies involve care teams. Many individuals are now part of every physician-patient encounter. Some are hands-on with the patient, some the patient never sees. New entities become part of care teams offering services from chronic care management, to behavioral health screening, to care coordination, to coding, charting and much more. With goals of lowering costs, increasing reimbursement, and improving outcomes, clinics can customize teams to individual patient needs. Keeping up with this rapidly evolving landscape can exceed the capacity of many medical groups. OBJECTIVES:

We will examine the diversity of care teams and how they interact. We will explore benefits that could result from improved coordination of these care teams. We will identify the barriers to this improved communication, such as incompatible EHRs and data privacy issues, and ways around them. We will provide examples of successful integration of clinical and non-clinical care teams and a road map for adopting and scaling these models for all elements of our health care delivery system.

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INTERVIEW

A trusted voice to create positive change Rose Roach Minnesota Nurses Association (MNA) MNA has successfully grown and adapted to the needs of its members as health care delivery evolves. What are some examples?

Health care technology is one such change, but MNA nurses have legally binding contracts with language that provides a voice for nurses to ensure that technology does not impact patient care. One example would be the use of acuity tools to help determine patient staffing needs and basic charting through systems such as Epic. Nurses believe, however—in their professional, “hands-on” judgment related to patient care—that more time spent at the computer rather than at the bedside puts both patients and the nursing profession at risk.

a specific number of patients to care for during their shift. As science and technology continue to make advancements, people live longer. Inevitably, people in our hospitals are much sicker than they ever used to be. Patients have surgery and are

Nurses are also very focused on protecting patients, hospital staff, and themselves from the violence that has become a daily occurrence at hospitals. Nurses are constantly pushing hospitals to increase security, implement de-escalation training for employees while tracking violent occurrences, and involve RNs in the discussion of solutions to prevent workplace violence.

Another recent attempt by hospitals to save money is through the implementation of “Lean” management initiatives. Nurses have used their collective voices to ensure that such initiatives do not come at the expense of patients.

Right-to-work laws and the lobby around them pose serious problems. What can you tell us about this?

You advocate for single-payer health care. What can you share with us about this?

We are penny-wise and pound-foolish in this country when it comes to health care. We blame the diabetic for struggling to take their insulin when the price of insulin has risen 3,000 percent, but we never hold the pharmaceutical companies accountable for the deaths they cause due to diabetic ketoacidosis. It costs $15,000 per day for an intubated diabetic in the ICU because he or she couldn’t afford the $700 per month insulin. None of us should die sooner than we’re supposed to simply because we couldn’t afford the care we need when we need it.

“...” We are penny-wise and pound-foolish in this country when it comes to health care. “...”

Every one of us needs, or will need, health care. Instituting barriers to care through narrow networks, high deductibles, and co-pays is immoral, inhumane, and financially irresponsible. Health care is not a consumable good. It’s a public good. We don’t notice that chemotherapy is on sale and then try to get cancer to take advantage of the discounted price.

issue is to achieve proper staffing levels based on their judgment of the acuity needs of their patient. Nothing concerns nurses more than when they have so many patients requiring attention that they are forced to “prioritize” based on severity of medical need at a given moment.

discharged on the same day. Nurses are expected to keep working faster, regardless of what the patient needs. Nurses have a legal, ethical, and moral obligation to not accept more patients than they can reasonably care for at one time. Patients are in the hospital because they need nursing care; otherwise, they would be outpatient.

MNA believes in the workers’ right to organize a union and collectively bargain a contract. We oppose any efforts to silence employees’ collective voices in their workplace, including the anti-union effort to make Minnesota a “right-to-work” state. We work alongside our brothers and sisters in the AFL-CIO unions to make sure that any attempts to make Minnesota a right-to-work state are defeated. With the ongoing consolidation of health care and an increasing number of physicians becoming employees, what benefits might be gained if physicians unionized?

They would gain power. The only way to deal with the industry’s push to take the patient’s needs out of the center of the health care system is for providers to come together in solidarity to fight for their respective professions and patients. Physicians, like nurses, are experiencing severe burnout as corporations dictate care overriding physicians’ professional assessments. Physicians would once again have a say in the treatment of their patients and in their profession.

Staffing ratios are a key priority for the MNA. Please tell us about these issues.

In addition to being a professional association, the MNA is also a labor union. What are some of your labor issues?

What are some of the legislative issues that the MNA will focus on this coming session?

Nurses have to care for too many patients at one time. Nurses on every patient unit are assigned

Nurses uniquely use the collective bargaining process for patient advocacy. Their number one

MNA is in the process of putting together its legislative agenda for the 2019 session.

MAY 2019 MINNESOTA PHYSICIAN

Issues that may come up at the Capitol in 2019 include: ensuring there is a funding source for MinnesotaCare, to replace the provider tax that is slated to sunset on Jan. 1, 2020; expanding MinnesotaCare so that more people can buy into it; strengthening workplace violence prevention laws; addressing gun violence prevention initiatives; and dealing with the rising cost of prescription drugs. The roles of advanced practice providers and care teams continue to expand. From a nursing perspective, how could interactions with physicians be improved?

Mutual respect is the key word, even though physician organizations’ oppositions to expansion of scope of practice for advanced practice registered nurses (APRNs) remains a significant obstacle. In addition, we believe that: • Collaboration and team approaches are the only ways that physicians and APRNs can provide safe, quality care to patients and the community. • APRNs should be allowed to practice to the full extent of their education. • The profession should understand that APRNs are not taking over physician jobs, but

are filling the gaps in the health care needs and shortages of primary care providers. • The Institute of Medicine states that it is imperative that all health professionals practice to the full extent of their education and training to optimize the efficiency and quality of services for patients. • The term “independent practice” for APRNs has become a charged term for some physician groups, which view it as implying solo or competitive practice. MNA operates a booth at the Minnesota State Fair. What stories can you share?

The fair gives nurses a chance to talk directly to patients about health care issues. We’re building a community of patients who want to help us tackle these issues together. At one recent fair, a man wearing a National Rifle Association patch wanted to talk to a nurse about health care and the rising costs and declining care. He ended up signing our petition and joining our mailing list of single-payer advocates. That kind of story tells us that we’re all hurting from the state of health care, and that nurses are a trusted voice to create positive change.

What new ways can nurses and physicians partner together?

Nurses should be instrumental in the development of collaborative teams. Having the right people on a collaborative team for process improvement in patient care is critical to a successful improvement effort. Nurses should have a strong voice on health care teams that seek to build a better process of communication. Open communication between leadership and nurses, and mutual support of the health care team, are certainly in the best interest of patient care. Nurses would advocate for a team environment that increases open, nonjudgmental communications, and would participate in a health care-driven team approach designed to improve patient care. Rose Roach is the executive director of the Minnesota Nurses Association. She has also served on Gov. Mark Dayton’s Task Force on Health Care Financing and the City of St. Paul’s Earned Safe and Sick Time Task Force. She attended Metro State University in St. Paul and Inver Hills Community College in Inver Grove Heights.

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3Change management from cover

with so much external change, that resistance to internal change management programs continues and may even be growing within physician ranks.

provide this necessary support to health care workers before, during, and after any system change or process improvement.

Change management or rigid mandate?

When physicians and other health leaders resist change, it can be challenging for administrators and change agents to introduce and implement new systems and process improvements. When faced with resistance, management can easily fall into the trap of issuing rigid mandates disguised as quality improvements. This often leaves organizational change agents feeling like a modern-day Sisyphus, Embracing change is not optional, dragging unwilling participants up the hill toward the it’s a requirement to survival. desired outcome, only to repeat the same effort the next day, and the day after.

When it comes to quality improvement and the transformation required to thrive in a value-based care environment, the idea of facing one more process improvement can seem overwhelming. In fact, when there’s a choice between making a change and maintaining the status quo, most people choose the latter. So how can physicians and other health leaders not only implement change but achieve strong engagement around change (or even “joy”), particularly when many health care workers are feeling burned out and disillusioned? There isn’t an easy answer. Too often, what organizations call “change management” are actually top-down management mandates, instead of what should be an inspirational, creative practice.

The practice of medicine has faced unbelievable amounts of change over the past decade. Much of that change has been externally driven, from federally mandated electronic health records, to the introduction of the ACA and the implementation of Medicare star ratings. Further disruption has resulted from medical information being widely available on the internet. This has armed health care consumers with knowledge, but at times has created challenges when the information was of poor quality. It’s not surprising, faced

Obviously, there’s a problem with change management in health care. At quality improvement workshops led by the Institute for Clinical Systems Improvement (ICSI), we’re asked the same question over and over again: “How do we get people to participate in improvement?” The answer is not rigid mandates, which create defiance rather than engagement. The answer lies in creating an atmosphere that embraces collaboration and the co-creation of solutions. Simply put, the answer is a return to teamwork. Physicians can and must be the leaders in transforming how health care approaches and manages change and quality improvements. They must embrace the idea that the responsibility for any improvement resides with everyone, not just the quality improvement (QI) staff or a designated change agent. Most health care organizations already have a good understanding of Lean and Six Sigma principles. It’s the engagement skills that have been left behind. To truly engage people within health care, change has to be a collaborative process. Physicians should play a strong role in moving to what often constitutes a brand new mindset around change management

Developing the “how” through small tests of change

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Redefining change management can benefit from taking a fresh look at the Model for Improvement (MFI) developed by quality experts Gerald J. Langley and Kevin M. Nolan, authors of “The Improvement Guide: A Practical Approach to Enhancing Organizational Performance.” Although most health care leaders “know” the MFI, the actual implementation of the MFI and its associated tools may not always be carried forward in its true spirit of trial and learning. In our experience, most organizations are taking on activities that are too big for the MFI’s Plan-Do-Study-Act (PDSA) cycles. Using smaller PDSAs can further change more effectively. By involving the team in specific, smaller cycles, PDSAs can also serve as a vehicle for re-introducing a more collaborative approach. Evidence has shown that testing hypotheses on a small scale actually speeds up improvement. The cycles iterate more quickly, and knowledge is acquired more rapidly. It’s clear that nearly everyone understands “what” needs to be done. It’s usually the “how” that isn’t planned well. The “what” is often the mandate, such as a strategic goal, or compliance to certain required metrics. Redefining the “how” can help achieve stronger engagement, by using a team approach and building a solution that reaches the desired outcome.

Steps to engaging the team in quality improvement Most health leaders and other change agents feel they’ve tried just about

everything, and many are frustrated by their inability to motivate teams to improve. What usually hasn’t been tried, however, is asking the team to participate in creating the “how.” It may seem like a leap of faith to believe that the team will co-create strong solutions, but in most cases, that’s exactly what happens. While there is some variation depending on the size of the team and the situation being addressed, most successful engagement follows these four steps: 1. First, clearly define the non-negotiable “what.” In other words, be clear about the goal that must be achieved. Explain that the status quo is not an option and that their participation is a necessary and vital part of developing process improvements. Physicians should consider using data and patient stories that help support the staff’s understanding of the goal.

and then co-create possible solutions based on ideas generated from the team. Solutions may not be clear at first, but there needs to be a sense of freedom and safety to explore any avenue. Physicians are trained to be analytical and find problems, but this is a time to hold back on analyzing potential outcomes. This allows many possible solutions to be considered before choosing what to try. 4. Finally, experiment with small PDSA cycles. As the team examines the results of each test cycle, they need to be willing to use what works, keep testing those which seem promising, and abandon ones that simply didn’t work. It’s important for new processes to represent real improvements, not merely changes. This is the phase where a physician’s strong analytical skills can and should be used.

Too often, what organizations call “change management” are actually top-down management mandates.

2. Next, encourage ownership of the “how.” Gather ideas from the team in a group setting on ways to accomplish the goal, and/ or to reach the desired outcome. Ask them to hold each other accountable for contributing ideas. Physicians can support the QI facilitator in this idea-gathering phase by encouraging all members of the team to share ideas. An outside facilitator can be helpful when doing this exercise with a new team. 3. Now, focus on embracing every idea. Create a safe environment where all suggestions have a place on the table to be considered by the team. The goal is to gain a better understanding of the problem together,

A major premise of improvement experts Langley and Nolan’s guide is that change isn’t achieved through the implementation of a single solution. It’s the impact of several changes that have the most effect on the whole system. Understanding this, and adopting an iterative, team-based approach, can accelerate quality improvements. Team members feel a sense of ownership around the improvements, which in turn results in more engagement in the future. Change management to page 384

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MINNESOTA PHYSICIAN MAY 2019

3Evidence synthesis from cover reviews, and discuss future challenges and opportunities, with suggestions to assist readers in utilizing findings to improve health care quality.

Evidence synthesis at the Minneapolis VA Health Care System

medical organizations, including the American College of Physicians, the American Urological Association, and the National Kidney Foundation. We also support reviews initiated by clinicians, health care systems, and researchers to improve care quality or serve as foundations for research grant applications.

Evidence synthesis and methods work is often conducted in collaboration with other The Minneapolis VA ESP is comprised of evidence reviewers, including Philipp Dahm, a multidisciplinary group of clinicians and MD, MHSc, coordinating editor of Cochrane researchers with expertise in health care practice, Patient data … can lead to Urology (Urology Section). Dr. Dahm and policy, and research. The ESP receives funding meaningful improvements in Shahnaz Sultan, MD, MHSc (Gastroenterology from the VA Quality Enhancement Research patients’ experiences and health. Section) are international leaders in evidence Initiative and is under the direction of Timothy review methodology. As members of the Grading Wilt, MD, MPH, general internist and health of Recommendations Assessment, Development services researcher and professor of medicine at and Evaluation (GRADE) Network, they provide the University of Minnesota. The ESP is one of national training and mentorship in systematic four nationally funded VA programs and part of reviews and evidence-based health care. We also partner with the University the Minneapolis VA Center for Care Delivery and Outcomes Research, a VA of Minnesota School of Public Health as the Agency for Healthcare Research national Health Services Research and Development Center of Innovation. and Quality (AHRQ)-funded Minnesota Evidence-based Practice Center Our evidence teams prepare rigorous, readable, and relevant syntheses of (EPC), co-directed by Dr. Wilt and Mary Butler, PhD, MBA, associate published scientific literature and make their findings available to clinicians, professor of the School of Public Health. managers, and policymakers to improve the health of Veterans and others. Nancy Greer, PhD, is the ESP program manager, and Wei (Denise) DuanPorter, MD, PhD, is associate director. In addition to VA reports, our evidence team conducts reviews funded by and designed to inform clinical practice guidelines for multiple

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Background on evidence synthesis programs ESPs produce and disseminate systematic reviews of existing evidence to: identify effective services to improve patient outcomes; avoid ineffective, wasteful, and potentially harmful care; support development of evidencebased policies, practice guidelines, and performance measures; and set the direction for future research to address knowledge gaps. ESPs help VA fulfill its vision of functioning as a “learning healthcare system” to improve Veterans’ health and health care. ESP teams are comprised of a core group of individuals with expertise in systematic review methodology complemented by project-specific content experts. ESP members provide disclosures and are not permitted to have significant scientific or financial conflicts of interest. Topics are nominated by clinical and policy stakeholders, who help refine key questions to ensure they are clinically useful while remaining manageable in scope. Questions are developed to address clinical benefits, harms, and costs, as well as implementation barriers and facilitators using a PICOTS framework (Patient, Intervention, Comparator, Outcomes, Timing, and Setting). ESP reports begin with executive summaries highlighting key findings. Full reports include detailed methodological information, results, and discussion of research gaps and policy implications. Reports undergo peer review with a focus on highlighting findings useful for clinicians and policy makers. Technical reports are available online throughout the VA and in the public domain, and summaries are often published in medical journals and presented in national VA Cyberseminars. “Management e-Briefs” are prepared to provide succinct nontechnical information to VA management and policy leaders, enhancing implementation. Project timelines range from several months to one year.

Evidence reports and their impact on health care practice and policy Four examples highlighting the range of topics and health care impacts:

support. The report, led by Dr. Greer in collaboration with Jennifer Bolduc, The utility of screening pelvic examinations. While more than 60 PharmD, focused on pharmacist-led care for patients with diabetes, hypertension, million pelvic examinations are conducted each year, often as part of a and lipid disorders, comparing outcomes with those of patients who did not general wellness exam, the utility of the pelvic exam is not known. The participate in pharmacist-led care (defined in the report as “usual care”). VA Office of Health Promotion and Disease Prevention and the Women’s Health Network requested a review evaluating Data from 63 studies indicated that pharmacistthe diagnostic accuracy, clinical benefits, and led care, when compared with usual care, was potential harms of the pelvic examination in associated with comparable numbers of visits to asymptomatic, nonpregnant women. Led by primary care offices, urgent care, or emergency Hanna Bloomfield, MD, MPH, results from departments; hospitalizations; and medication Rigorous reports that do not 52 studies found no data supporting the use of adherence. Pharmacist-led care increased the number align with clinical and policy pelvic examination in asymptomatic, averageor dose of medications received and improved needs are not useful. risk women. Low-quality data suggested that glycemic, blood pressure, and lipid goal attainment. pelvic examinations may cause pain, discomfort, Mortality and clinical events were similar. Evidence fear, anxiety, or embarrassment in about 30 on patient satisfaction was mixed. Further research percent of women. Report findings led to VA is needed to determine whether pharmacist-led care clinical guidance statements. The American improves clinical outcomes. The results support College of Physicians subsequently developed health systems expanding the role of pharmacist-led care, especially if targeted clinical guidelines recommending against performing screening pelvic intermediate goals have demonstrated beneficial outcomes. examinations in asymptomatic, nonpregnant women. Chronic musculoskeletal pain scales. Chronic musculoskeletal pain is Evaluating pharmacist-led care. Pharmacists have expanded their a major source of disability and morbidity. Management remains challenging involvement in patient care, including independent prescribing privileges. This and pain experts have called for more strategic pain therapy research. A VA may increase access, improve outcomes, and lower costs. The VA National State of the Art Conference on chronic musculoskeletal pain management and Clinical Pharmacy Research Group and Pharmacy Benefits Management the VA Pain Measurement Outcomes Workgroup requested a review describing program requested an evaluation of the effectiveness and harms of pharmacistexisting research on key psychometric properties of self-report measures of pain led chronic disease management, which may include medication monitoring, medication therapy review, prescribing authority, and/or disease self-care and Evidence synthesis to page 104

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3Evidence synthesis from page 9

required because they can lead to biased and contradictory findings not easily discerned. This can result in distrust in “evidence-based” health care, in part because evidence reports require numerous decisions to efficiently summarize original research. These decisions should be transparent and defendable. (See sidebar for questions to ask when critically appraising systematic reviews.)

severity and functional impairment. To address their needs in the rapid time frame required, we conducted a “rapid review and evidence map.” We developed this approach to illuminate the research gaps and data synthesis challenges. Led by Elizabeth Goldsmith, MD, PhD, we found that five measures had the most evidence, though there was substantial variation in estimating psychometric properties, defining chronic musculoskeletal pain, [Physicians] often find it difficult and reporting patient demographics. Further to identify the “right information” research is needed to validate patient-reported pain about the effects of health care outcome measures in populations with chronic interventions. musculoskeletal pain. Preventing long-term nursing home placement. Nursing-home placement has high financial and social costs. Identifying modifiable determinants of, and interventions to reduce, long-term nursing home placement can improve patient- and caregiver-centered outcomes and reduce health care costs. An ongoing review, led by Wei (Denise) Duan-Porter, MD, PhD, is intended to enhance national VA program policies and practices to optimize the ability of Veterans to remain in their own homes if desired.

Challenges and opportunities Evidence synthesis teams must overcome future challenges. These include incorporating advances in systematic review methodology and enhancing results communication. Reducing the overabundance of systematic reviews that are scientifically flawed or conducted by groups with strong conflicts is

However, rigorous reports that do not align with clinical and policy needs are not useful. Future evidence synthesis team roles include assisting partners to identify steps required for reliable evidence reports, as well as where and if additional value lies in conducting a report. Evidence reports must increasingly be responsive to rapid advances in medicine and end-users’ timelines. Tradeoffs between “scientific thoroughness” and timeliness are required, though large consequences exist with flawed shortcuts because evidence reports inform practice implementation and performance measurement development. “Socializing” evidence reports and carefully engaging in “informed speculation” is challenging, but allows evidence reports to serve as a trustworthy “bridge” between rigorous, refined research settings and unique day-to-day patient care experiences. As the amount of knowledge and needs of stakeholders expands, “living guidelines” with continuous evidence updates or searches for signals of important new information will be required so that review findings remain up-to-date. Despite these challenges, numerous opportunities exist. Clinicians will increasingly need accessible, reliable evidence to address questions relevant

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to their patients. Health care systems will seek guidance on local policy and purchasing decisions; e.g., should they design and put into place new multicomponent pathways for post-operative care and, if they do, what implementation barriers and facilitators exist; are the benefits of selected technologies worth the upfront and downstream harms and costs; what are the comparative trade-offs when selecting among different medications for inclusion on a pharmacy formulary; can “smart” electronic reminder systems be established to enhance personalized care quality based on reliable evidence of benefits and harms and, if so, how will they be used to derive and monitor pay-for-performance? Researchers and funders will want to know what evidence gaps exist and the types of research needed to close clinically important gaps.

Wei (Denise) Duan-Porter, MD, PhD, is a general internist at the Minneapolis

Rigorous, readable, relevant (and timely) systematic reviews and their accompanying practice guidelines will increasingly be valuable resources to help fill these needs. The Minneapolis VA ESP and other Minnesota evidence synthesis groups welcome opportunities to assist stakeholders define, discover, and deliver high value health care.

led evidence reports across a wide range of health care topics.

Timothy Wilt, MD, MPH, is a general internist and health services researcher at the Minneapolis VA Center for Care Delivery and Outcomes Research and professor of medicine at the University of Minnesota. He is the director of the

VA Health Care System, health services researcher at the Minneapolis VA Center for Care Delivery and Outcomes Research, and assistant professor of medicine at the University of Minnesota. She is the associate director of the Minneapolis VA Evidence-based Synthesis Program. Her research has focused on improving patient-centered outcomes and quality of care for medically complex older adults.

Nancy Greer, PhD, is a health science specialist at the Minneapolis VA Center for Care Delivery and Outcomes Research. She is the program manager for the Minneapolis VA Evidence-based Synthesis Program (ESP) and project manager for ESP and other evidence review projects, overseeing a team of project coordinators and research assistants. She has conducted and

STATISTICAL ANALYSIS

Minneapolis VA Evidence-based Synthesis Program and co-director of the Minnesota AHRQ-Evidence-based Practice Center. Dr. Wilt’s clinical and research interests are in health promotion and disease prevention, detection, and treatment, with an emphasis on enhancing high value care and reducing low value care.

Questions to ask when critically appraising systematic reviews

SURVEY MANAGEMENT MANUSCRIPT SUPPORT

• Do the key questions address the clinical situation relevant to my patients and practice? • Was the literature search comprehensive and up-to-date? • Are clinical benefits and harms, including costs and burden, adequately considered? • Are results presented in absolute as well as relative terms? • Are important patient and condition subgroups evaluated (e.g. age, sex, race, condition severity, and comorbidities)? • Is there an assessment of individual study quality and overall results’ certainty? • Are the conclusions justified by the results?

Transforming data into actionable insights since 1984.

Our statisticians collaborate on research, patient outcomes, and quality improvement projects. We have over 30 years of experience providing exceptional consulting services to physicians in the Twin Cities.

• Are conflicts of interest (including the funding source) disclosed and could they affect the findings and conclusions?

TECHNOLOGY

Social engineering Is your practice prepared?

BY GINNY ADAMS, RN, BSN, MPH, CPHRM he human element is a key factor in cyber and computer network operations, and it is the most unpredictable factor in cybersecurity. Patient records contain a wealth of personal information, and many hackers have learned to trick unsuspecting health care employees into helping them plan and execute their data breaches through “social engineering,” defined in information security terms as the art of using influence or manipulation to trick targets into giving up confidential information or access to an organization. Cybercriminals will often use social engineering tactics as a first step in gaining access to privileged information because it is generally easier to exploit human weaknesses than to breach network or software vulnerabilities.

on a link and/or entering personal information, allowing access to a network or system to collect billing and health information or deposit malware. Phishing emails and websites are often designed to look as if they have come from a legitimate source. In November 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) notified health care-covered entities of a phishing scam that used fake government letterhead and a fake email address to direct individuals to a fake URL. The fake email address and fake URL each had only a very subtle difference (a single added hyphen) from the official addresses, a typical approach in phishing scams.

Spear-phishing is a specific method of phishing that targets specific individuals or groups within an organization. Emails, social media, and other platforms can be used to persuade users to According to the 2016 Healthcare Industry divulge personal information or perform actions Cybersecurity Report (Information Security Media Many hackers have that lead to network compromise, data loss, and/ Group), health care ranks 15th out of 18 industries learned to trick unsuspecting or financial loss. While phishing often involves in social engineering. This is a clear reflection of health care employees. random individuals, spear-phishing is aimed the vulnerability of health care organizations to at specific targets and involves prior research. this type of breach. That same report said that data According to the Internet Crime Report breaches occurred in 85 percent of large health published by the FBI’s Internet Crime Complaint care organizations’ systems in 2014. Center (IC3), phishing and related tactics were Social engineering depends on human the third highest cybercrime experienced across the nation in 2017. inclinations toward trust, curiosity, and empathy. One of the reasons that social engineers love health care employees is their natural tendency to Business email compromise be trusting and their desire to be helpful. The complexity of most health Business email compromise (BEC) is a sophisticated crime that typically care organization structures, networks, and systems is also an advantage to targets employees who have access to company finances. The cybercriminals social engineers. trick these individuals into making a wire transfer to accounts thought to belong to trusted partners, but are actually controlled by the criminals. One form of social engineering that allows cybercriminals to physically gain entrance is called tailgating. Here are some common scenarios: 1. A social engineer flashes a fake ID at the front desk. He says he is there to fix an internet problem and the IT department sent him down. He is led to the router and is able to install malware onto the entire health care network. 2. A social engineer shows up at the employee entrance with an armful of pizza boxes. A helpful employee holds the door open for him and he has gained access to non-public areas. 3. A social engineer calls in posing as an assistant to a high profile physician. His boss is having problems accessing the system and he demands to know why. Acting rushed and annoyed, he demands immediate access to the system. More commonly, cybercriminals act remotely, using electronic social engineering techniques. Common examples include phishing and spearphishing, business email compromise, and ransomware.

Phishing and spear-phishing Phishing attacks use email or fake websites to trick employees into clicking

MAY 2019 MINNESOTA PHYSICIAN

BEC, also known as CEO spoofing, often starts by the criminals gaining access to a company’s network through a spear-phishing attack and the use of malware. This allows the criminals to study the organization’s vendors and billing systems, as well as the CEO’s style of communication and perhaps even his or her travel schedule, without detection. When the time is right, a spear-phishing request is made to a specific individual, such as a bookkeeper, accountant, controller, or CFO, requesting an immediate wire transfer, often to a trusted vendor. If paid, this money is often hard to recover due to laundering techniques and accounts that drain the funds into other accounts that are difficult to trace.

Ransomware Ransomware is a type of malware in which attackers lock the data on a victim’s computer, typically by encryption, and payment is demanded before the ransomed data are decrypted and access returned to the victim. In 2017, the FBI’s IC3 received 1,783 ransomware complaints with adjusted losses of over $2.3 million. Unlike other types of attacks, the victim is usually notified that an exploit has occurred and is given instructions for how to recover from the attack. Payment is

often demanded in a virtual currency, such as bitcoin, so that the cybercriminal’s identity isn’t known. Of course there’s no guarantee that the criminals will release the files or that the files have not been breached or disrupted in some way. There is usually a delay between the insertion of the ransom software and the execution of the attack. This delay is intended to enhance the spread of the ransomware throughout the system, especially into backup files. This decreases the likelihood that the data can be recovered without paying the ransom.

Lines of defense So how do you prevent social engineers from having a negative impact on your organization? One certainty is that as technical security factors become more stringent, social engineering techniques will respond in kind. The weakest link in the security chain is the human who accepts a person or scenario at face value. Although some technical barriers can be put in place, employee training is the most important defense an organization has to protect against social engineering crimes.

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Consider the following tips to reduce your risk: Email attacks To reduce the risk of a phishing attack, keep malware and spam filters up to date. To reduce the risk of falling victim to BEC, implement a formal structure and process for releasing information and making payments. Employees should be trained to be very suspicious of an email directive to wire money, mail a check, or release personal information. Consider the following actions recommended by the FBI’s IC3 (2016): • Verify changes in vendor payment location and confirm requests for transfer of funds.

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• Consider financial security procedures that include a two-step verification process for wire transfer payments. Double-check with a human. Call to verify and use the corporate telephone book rather than calling the numbers listed in the email. • Do not use the “Reply” option to respond to any business emails. Instead, use the “Forward” option and either type in the correct email address or select it from the address book to ensure the intended recipient’s correct email is used.

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Social media security Develop and implement a policy on employee use of social media, including personal page posts and references to the organization. Train your staff members on locking down their personal social media pages, and inform them of the risk to their personal property and well-being when too much personal information is shared.

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Ransomware To reduce and/or mitigate the risks of ransomware: • Develop a response plan, which may require outside experts. • Physically back up files outside of the network each day. Make a copy on electronic media or an encrypted external hard drive. Maintain the files in a secured location, preferably off-site or on a firewall-protected network or “cloud,” and periodically test them. • If you experience a ransomware attack, notify all system users and shut down the systems as soon as possible to contain the spread. Social engineering to page 364

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MEDICINE AND THE LAW

“Stark” legislation and regulation Updating the updates BY ANTONIO “TONY” FRICANO, JD

A “brief” history of Stark

n June 20, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that there will be what CMS called a “Regulatory Sprint” to revamp the Physician SelfReferral Law (commonly referred to as the “Stark Law,” named for its original sponsor, California Congressman Pete Stark). CMS is seeking recommendations and input from the public on how to address any undue impact and burden of the Stark Law on care coordination and delivery of value-based care. Under the current administration, CMS leadership has made it clear that one of its top priorities is to scale back regulations where the government is overstepping its grounds and unduly burdening providers—in some cases leading to significant potential liability for providers.

It is beyond the scope of this article to discuss every exception, definition, or test applicable to a Stark Law analysis of what may be considered an improper physician self-referral, but a brief summary will illustrate its history.

This article will illustrate how the Stark Law has developed over time; discuss the application of Stark under the current regulations, as well as some of the practical challenges encountered by providers today; and speculate on some of the courses CMS may take on this issue.

Initial purpose. The Stark Law is a set of federal laws that prohibit physician self-referral to an entity with which the physician (or an immediate family member) has a financial relationship. At the time of enactment, Congress reasoned that a bright-line rule would help physicians self-regulate and avoid fraud and abuse issues. Despite this initial intent, the law has been expanded and modified over the years through various pieces of legislation, resulting in a complex and convoluted framework of laws that involve very few bright lines. Further complicating the issue is that there is no “intent” requirement for the Stark Law (e.g., no demonstration that the provider had knowledge of wrongdoing). Even unknowing providers with no malicious intentions could be in violation of the Stark Law and subject to massive monetary fines for technical violations. Stark I. The first iteration of the Stark Law (Stark I), which passed as part of the Omnibus Budget Reconciliation Act of 1990, prohibited a physician from referring a Medicare patient to an entity for clinical laboratory services if the physician or the physician’s immediate family member had a financial relationship with the entity. The statute provided for several exceptions to the prohibition, with some applying to ownership arrangements and some applying to compensation arrangements (or both). Stark II, Phase 1. Shortly after passing Stark I, Congress agreed that the limitation of Stark to clinical laboratory services was too narrow. This led to the passage of “Stark II,” as part of the Omnibus Budget Reconciliation Act of 1993, which expanded Stark to cover Designated Health Services (DHS) and expanded coverage to Medicaid programs. The 10 categories of DHS included in the rule are: 1) clinical laboratory services, 2) physical therapy, occupational therapy, and speech-language pathology services, 3) radiology and certain other imaging services, 4) radiation therapy services and supplies, 5) durable medical equipment and supplies, 6) parenteral and enteral nutrients, equipment, and supplies, 7) prosthetics, orthotics, and prosthetic devices and supplies, 8) home health services, 9) outpatient prescription drugs, and 10) inpatient and outpatient hospital services. There were also several definitions that were added and revised in this iteration of the law. Stark II, Phase 2. On March 26, 2004, CMS published Phase 2 of Stark II (Phase 2), intending to define prohibitions narrowly and the exceptions broadly. Some important provisions of Phase 2 are: 1) the creation of the holdover exception for lease arrangements, 2) the allowance for termination of agreements prior to one year (provided no new agreements may be entered into within that year), 3) the exclusive use of space or equipment by lessee requirement for leases, 4) clarification on the regulations related to productivity bonuses for physicians, and 5) clarification that the “set in advance” requirement for compensation arrangements allows payment based on percentages of collections.

MAY 2019 MINNESOTA PHYSICIAN

Stark II, Phase 3. On September 5, 2007, CMS published the Phase 3 Final Rule on Stark (Phase 3). In this iteration of the rule, CMS: 1) indicated that fair market value can be determined using any commercially reasonable methodology that is appropriate under the circumstances, 2) extended the holdover exception from leases to personal service arrangements, and 3) indicated that physicians “stand in the shoes” of their group practices, thus requiring a direct exception to the Stark Law in situations where an indirect compensation arrangement exception would have previously sufficed. Stark modifications under the Hospital Inpatient Prospective Payment System (IPPS). There were significant changes to the Stark Law affecting its application to hospitals that were part of the 2009 IPPS Final Rule. First, the “stand in the shoes” requirement of Phase 3 was eliminated for physicians that were not owners in the group practice. Second, CMS revisited the percentage-based compensation discussion from Phase 2 and restricted the use of percentage-based compensation in the fair market value, indirect compensation, and office and equipment lease exceptions under the Stark Law. Third, CMS prohibited per-click lease arrangements (unit-based compensation in arrangements for the rental of office space or equipment). Fourth, CMS added a grace period under certain circumstances for obtaining signatures in order to meet an exception’s technical requirements. Finally, CMS provided guidance for calculating the period of disallowance for Stark Law penalties. Stark Waivers under the MSSP (Medicare Shared Savings Program), ACO (Accountable Care Organizations) Program, and BPCI (Bundled Payments for Care Improvement) Program. Section 1115A(d)(1) of the Social Security Act authorizes the Secretary of Health and Human Services to waive certain fraud and abuse laws (including the Stark Law) for certain service delivery models developed by the Center for Medicare and Medicaid Innovation (CMMI). The extent of the waivers and conditions vary, but currently there are waivers for 11 different programs (see www.tinyurl.com/mp-waivers). 2016 Medicare Physician Fee Schedule Final Rule (“2016 Final Rule”). The 2016 Final Rule included multiple provisions impacting Stark. In a significant turn of events, CMS indicated that the Stark Law writing exception can be met through a collection of documents, noting examples of documents that together could form the basis for a contract. Even though this added new options for providers seeking to fit prior arrangements into an exception, the issue has been litigated and courts have held that the documents must contain clear indication of agreement. Additionally, CMS expanded the grace period for signatures to 90 days (inadvertent or not). CMS also clarified that as long as a contract lasts one year, it doesn’t matter that the term in contract isn’t for one year. CMS provided detailed guidance on timeshare leases and CMS also indicated that holdover leases could continue indefinitely, as long as certain conditions are met.

Analysis under the current regulatory framework The Stark Law prohibits a physician from making referrals for DHS to any entity with which the physician has a financial relationship, unless the arrangement qualifies for an exception. If a provider is ever in a position to receive referrals of DHS, it is important that there be a process put into place to ensure Stark compliance. Below is a very high-level framework for such a process: First, to determine whether Stark applies, we need to ask: 1. Does the arrangement involve a “physician”? 2. Does the “physician” or an “immediately family member” of the physician have a “financial relationship” with the “entity furnishing DHS”? 3. Is there a “referral” of “DHS”? “Stark” legislation and regulation to page 344

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Penalties for non-compliance. Some of the penalties for violating the Stark Law include: 1) denial of payments and/or refund of payments received, 2) fines of up to $15,000 for each service provided, 3) three times the amount of the improper payment received from Medicare, 4) exclusion from participation in health care programs, and 5) civil penalties of up to $100,000 for each circumvention scheme. In addition, under the False Claims Act, providers face exposure for private causes of action for Stark Law violations, providing significant monetary incentives for employees or competitors to prosecute violations.

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PHYSICIAN-PATIENT COMMUNICATION

Surviving a stroke Lessons learned from being a patient BY MICHELLE D. SHERMAN, PHD, LP, ABPP; AND LUANN KIBIRA, APRN, NP

“You’ve had a stroke.”

ach of us heard these words from an emergency room physician earlier this year, coincidentally about a month apart. Shocking? Life-changing? Perspective-offering? Reminding us of the importance of gratitude? Yes. We are friends and coworkers (a clinical psychologist and a nurse practitioner, respectively) in a family medicine residency clinic. We’ve each had over 20 years of experience caring for patients with a wide array of physical and mental health problems, but getting a serious diagnosis and being admitted to the hospital were uncharted territories. The experience was humbling, frightening, confusing, and overwhelming. Fortunately, we both have no residual damage from our strokes and are extremely grateful for great prognoses, excellent health care teams, and supportive families, friends, and coworkers. As we both spend much of our professional careers teaching resident physicians and trainees from other allied health disciplines, we often reflect upon teaching opportunities. Having a stroke, spending time in the hospital,

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and having mandatory time off work for recovery involved unique experiences and time for reflection. In attempting to make meaning of the journey, we have contemplated our experience as patients, including what was especially helpful and what was difficult in interacting with the health care team. We want to use our experiences to shape our teaching—and, hopefully, invite others to consider our lessons learned from the other side of the hospital bed.

What to tell patients Reflecting on our experiences as patients in the emergency room and hospital floor, we humbly offer the following recommendations for health care professionals: Be aware of how much information I can digest, especially shortly after a major medical event. One of us was visited bedside by a specialist three hours after the stroke. He stood at the end of the bed at 6 a.m. and gave a one-hour, highly detailed neurological overview of strokes and treatment options. Although I wanted information, I simply couldn’t assimilate this level of detail; hearing all this information and trying to absorb it was stressful. A simple, short explanation right away, followed by more details later, would have been more helpful. Sit down. Balance computer work with meaningful patient interaction. Although sitting down next to the patient is possibly a common-sense suggestion, we learned it is not a consistent practice by the providers in both our emergency departments and patient rooms. We both had a few physicians sit down in chairs by our beds, which allowed for more comfortable communication. However, many providers stood quite a ways away at the end of the bed, seeming to tower over us. We understand that documentation in the computer (oftentimes on standing platforms) is necessary, but some providers asked questions and documented information while looking primarily at the computer. Instead, start the interaction by sitting down at our level, and make eye contact whenever possible. Please use simple language and avoid acronyms. Even as seasoned health care professionals, we felt overwhelmed after our strokes. We were unsure of the cause of our strokes, and we asked ourselves what we might have done (or not done) that led to this medical event. We worried if the immediate post-stroke symptoms (e.g., headaches, dizziness) would go away. We wondered when we could return to work. We were afraid of having another stroke, and wondered what we could do to prevent a recurrence. While dealing with these questions and trying to cope with the shock of the diagnosis, we struggled to process new information. Providers’ use of technical terms, jargon, and acronyms made comprehension more difficult. Instead, offer concise explanations, repeat them, use layperson language, and elicit questions from the patient. Please be consistent in the terminology of medications. It’s confusing when health care team members alternate between generic (lisinopril) and brand (Prinivil) names ... and sometimes use drug class names (e.g., “ACE,” for “angiotensin-converting-enzyme inhibitor”) or even abbreviations (do you want your “dil”—for diltiazem).

MAY 2019 MINNESOTA PHYSICIAN

Drawings or written information are helpful, but check on patients’ preferences. In the hospital, we were each given detailed booklets on strokes that included key terms, risk factors, and treatment options. However, immediately after a major medical event, even opening such a book can feel overwhelming and daunting. We never thought that a book called “Life after stroke” would be relevant for us. We appreciated physicians who walked through key parts of the book and drew some basic pictures for us. Too much detailed information and too many visuals can be frightening, so please consider balance. One of us will never forget the pictures of the white spots in her brain, real proof of the damage done by the stroke. It would be helpful to ask patients if they want to see the picture rather than just showing them.

Words of encouragement are extremely helpful. As patients, we have not been through the routine “stroke protocol” and don’t know what to expect. Receiving reassurance and hope for recovery can feel very good. One us has had a good friend (who was incidentally also a physician) visit her on the first day after her stroke. His words —“you’ll only get better from here” (referring to the sequelae of this stroke)—were incredibly comforting and bolstered her spirits immensely.

Observing conflict among health care team members is distressing.

It would also be very helpful if patients could have a small notebook in which to write down their questions and the doctors’ responses. Seeing you consult with your colleagues is comforting, but observing conflict among health care team members is distressing. Patients appreciate when team members work together to define treatment options and understand there may be differences of opinion. However, watching you disagree in front of us and seeing you badmouth your colleagues is upsetting. Please address disagreements outside of the patient’s room.

Avoid terms of endearment. Although we definitely appreciate kindness and compassion, we are still your patients and ask that you maintain professional boundaries. Although we know you’re trying to be kind when you refer to us as “honey,” “sweetie,” or “dear,” we are none of those things to you; such terms can feel patronizing. Instead, ask us what we like to be called and then address us by our preferred name.

Being in the hospital can be boring, and we spend a lot of time waiting for doctors. We know you’re very busy and have many patients on your service. However, any indication of when you’ll be available or stopping by is very helpful (e.g., “I tend to round in the morning”). Being in a hospital gown in a hospital bed is a powerless, vulnerable, and confining experience. We couldn’t eat when or what we wanted (dietary Surviving a stroke to page 334

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PEDIATRICS

The Minnesota NET-Works program Addressing pre-school obesity BY SIMONE A. FRENCH, PHD; NANCY E. SHERWOOD, PHD; AND SARA VEBLEN-MORTENSON, MSW, MPH

pproximately 27 percent of children ages two to five are overweight or obese. Overweight children are at high risk for hypertension and other cardiometabolic risk factors and are five times more likely than normal weight children to become overweight adults. Children who identify as ethnic or racial minorities, and children in lower-income households, are at even greater risk for obesity. Childhood obesity is the result of a complex interaction between biological, behavioral, family-based, and community environmental factors, thus intervention at multiple levels and across multiple settings is critical for short- and long-term effectiveness. Public health efforts need to address all levels of influence on childhood obesity. However, primary care providers may more readily focus on family-level influences—and should stress the long-term health risks facing overweight or obese children.

Parents as agents of change Parents are vital agents in obesity prevention because of their central role in influencing their child’s eating and physical activity behaviors, and creating a home environment that supports healthful behaviors. Interventions that

directly and effectively engage parents are needed, but identifying how best to engage parents to affect the home environment is a major challenge. Parents with a lower income may experience even greater challenges in creating a healthful home environment due to the many stressors unique to their lives, including having limited income for food or housing, working several jobs with varied work schedules, and lack of access to affordable childcare.

Community environments In addition to the primary care setting, the neighborhood community environment may provide resources that could enhance or create barriers to parent efforts to support healthy eating and physical activity in their child. Neighborhoods may or may not have safe and attractive playgrounds and parks nearby, and access to affordable retail food stores varies across neighborhoods. Without perceived access to these healthful resources, parents may face significant economic, physical, and social barriers to adopting behavioral intervention messages related to healthful eating and physical activity. For example, small screen use (such as television, cell phone, computer, iPad) by their child might be viewed as a safe alternative to time spent playing outdoors in the neighborhood. Primary care providers can support parents’ efforts to create a healthful home food and physical activity environment by connecting them to existing neighborhood resources, including family-supportive organizations and programs.

The NET-Works Multi-Component Community-Based Pediatric Obesity Prevention Program

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The goal of the Minnesota NET-Works (Now Everybody Together for Amazing and Healthful Kids) study was to integrate home, community, primary care, and neighborhood intervention strategies to promote healthful eating, activity patterns, and body weight among low-income, ethnically diverse preschool-age children. Critical to the success of this intervention was the creation of linkages among these settings to support parents in making home environment and parenting behavior changes to foster healthy child growth. Participants were recruited in partnership with 12 Minneapolis-St Paul primary care clinics that serve diverse populations. Body mass index (BMI) > 50th percentile was an eligibility criterion because the trial was an obesity prevention intervention, and low-income, racial/ethnic minority children with BMI 50-85th percentile were considered at risk for excess weight gain. Children who were already in the overweight or obese categories were also included (BMI > 85th percentile). A child was eligible for the study if the child was between two and four years of age; had no medical problems that would preclude study participation; family income was below $65,000 per year; and a parent spoke English or Spanish. The families enrolled in the study were all low-income and demographically diverse. Fifty-eight percent of the enrolled children were Hispanic; 48 percent had BMI > 85th percentile; 75 percent of parents were overweight or obese; 55 percent of parents had high school or less education; 30 percent were working full time and an additional 28 percent were working

part time; 72 percent were married; 62 percent had annual household incomes of < $25,000/year; 43 percent of the households participated in the SNAP federal food assistance program; 37 percent were food insecure; and over 95 percent of children had health insurance. Over the three-year study period, families experienced many social and economic challenges. Thirty-seven percent of the 534 families moved once and an additional 25 percent moved two or more times.

children. NET-Works was also successful in reducing increases in BMI among high-risk subgroups. Children who were overweight or obese at the beginning of the study, and children who were of Hispanic ethnicity, significantly reduced BMI after three years, compared with comparison-condition children in these high-risk subgroups.

What do these findings mean for pediatric obesity prevention?

The multi-component, high-intensity, accessible intervention was designed to provide a consistent Approximately 27 percent of level of support to parents over a three-year period. Intervention settings and strategies were chosen children ages two to five are It was initially hypothesized that a longer, more based on social ecological theory, previous research, overweight or obese. intense dose would result in larger reductions in and potential for dissemination and sustainability child BMI by the end of three years. However, of the intervention. The program consisted of home given the competing priorities in these low-income visiting, community-based parenting classes, and families’ lives and changes in life circumstances telephone check-in calls. Referrals to community over a lengthy period, it seems necessary to revisit resources for healthy foods and physical activity the optimal dose and type of intervention contact. In the present study, we opportunities were embedded in the home visiting and parenting class observed that intervention families moved in and out of various intervention components. Intervention component curricula were developed and pilotprogram components across time. Families may have participated in home tested by the researchers and designed to be synergistic. The home visit setting visiting for several months, then taken a break for several months due to enabled behavior and home environment change strategies to be tailored for family circumstances, then later rejoined the home visiting program. The individual families, while the parenting class setting provided group support continuity in contact between the families and their home visitors enabled for behavior changes. Target behaviors and behavior change strategies were families to receive the intervention contact and dose that was feasible for them similar across the home visiting and parenting class components. Family behaviors and routines were targeted and included healthy food choices for meals and snacks, including limited sweetened beverages and high-calorie The Minnesota NET-Works program to page 234 packaged snack foods; increases in fruit and vegetable intake; reduction in screen time; and increased time spent in active play.

NET-Works Intervention Program

Planned intervention dose was the same across all three intervention years and included monthly home visits, a series of 12 community parenting classes each year, quarterly phone calls from the home visitor to check in about progress, and annual primary care provider visits. The home visiting and parenting class components were conducted by trained professionals with a minimum of a bachelor’s degree and several years of experience working with families and children. The home visitor met with parents and children in their own home, tailoring the intervention messages and strategies to best fit with the resources and motivations of parents. Home visits were about one hour in duration and were planned for monthly intervals with telephone check-in calls between home visits. Motivational interviewing and behavior change models were used as the intervention foundation. Weekly parenting class series were held in the communities where the family resided with the goal of having parents take part in a 12-week parenting class series each year. Efforts were made to accommodate family schedules and transportation was provided or reimbursed by the study. Referrals to community resources were designed to support parent and family use of food and physical activity resources in their neighborhood and were implemented through the home visits, parenting classes, and check-in calls. Families received an average of 35.4 contacts over three years (an average of 18.3 home visits, 9.3 parenting classes, and 7.4 check-in calls).

What were the main results of the study? After three years, the NET-Works program had no significant impact on the BMI of NET-Works-enrolled children compared with children in the usual care condition. NET-Works children did significantly reduce their television viewing and intake of calories and added sugars compared with comparison-condition

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BEHAVIORAL HEALTH

Opioid prescribing A new provider toolkit BY ANDREW R. ZINKEL, MD, MBA, FACEP, FAAEM, AND PATTY GRAHAM

been conducted, with more online sessions planned. Learn more at www. stratishealth.org/pip/opioids.html.

very day, an average of 130 Americans die of an opioid overdose, according to the Centers for Disease Control and Prevention (CDC). In 2017, 401 Minnesotans died from opioid-related causes, according to preliminary data from the Minnesota Department of Health (MDH). That’s an 18 percent increase over 2015. So it’s no surprise that state admissions data also show a rise in heroin and opioid addiction across the state. The link between the opioid epidemic and heroin use is clear: 80 percent of people who use heroin initially used prescription opioids, according to the National Institutes of Health (NIH).

Guidelines: 3–7 days for new prescriptions

Partnering to prevent misuse

Adopting the prescribing guidelines into clinical practice is one way to ensure that you are not over-prescribing opioids. Most published guidance around opioid prescribing, including the Minnesota Opioid Prescribing Guidelines and those issued by the CDC and ICSI, recommend no more than 3–7 days of opioids for a new prescription. Minnesota health plans have implemented prescription limits to align with the prescribing recommendations. To eliminate confusion about the amount of opioids that can be dispensed, consider changing the default opioid limit in your electronic medical record to a 7-day supply. If you prescribe for a longer duration and the amount dispensed is reduced at the pharmacy, your patient may be confused when their prescription is changed.

The Minnesota Opioid Prescribing Guidelines, released by DHS in 2018, break the phases of pain into three stages: acute, post-acute, and chronic. By focusing on appropriate prescribing and pain monitoring during the timeframe right after injury or surgery (acute and post-acute), clinicians can support their patients through their recovery, reduce the risk of their patients becoming chronic users of opioids, and limit the amount of unused opioids that may be used by someone else.

While policy makers look at implementing These numbers reflect a statistical focus on oversight—or on funding programs to impact this chronic opioid use or addiction. Minnesota health issue—clinicians struggle to balance patient needs plans and the Minnesota Department of Human with emerging evidence on opioid safety and efficacy. Services (DHS) are now taking a different Dr. Burt points out that “many patients receive Eighty percent of people who approach. Instead of focusing on supporting or their first opioid prescription from specialists who use heroin initially used tapering chronic opioid use, this collaborative are appropriately treating acute pain following an prescription opioids. effort seeks to reduce the likelihood that opioidaccident, injury or planned procedure. Specialists are naïve patients enrolled in Medicaid will become implementing processes to limit opioid prescriptions chronic users. The opportunity is significant: to less than seven days. The medical community DHS data show that in 2012–2016, an average of must closely monitor the impact this limit may have 5.8 percent of Medicaid members in Minnesota on primary care and urgent care providers.” who received a new opioid prescription became chronic users. While the guidelines are not intended to take treatment control away The data also show that opioid-naïve patients who used an opioid for from physicians, they do recognize that there has been wide variation in 45 or more days following a new prescription were more likely to become how opioids are prescribed across Minnesota, says Melissa Kizilos, MD, chronic opioid users. medical director at Blue Cross Blue Shield of Minnesota. The health plans involved with this project are Blue Plus, HealthPartners, Hennepin Health, Medica, PrimeWest Health, South Country Health Alliance, and UCare. Amy Burt, DO, associate medical director for UCare, believes partnership is important, since “the collaborative includes multiple stakeholders in order to mitigate unintended consequences that could negatively impact patients and providers.” The first deliverable of the project is a Provider Toolkit: Meeting the Challenges of Opioids and Pain (www.tinyurl.com/mp-opioid-toolkit), which consolidates evidence-based recommendations and resources into one easy-to-use resource. The tools are relevant to Minnesota and specifically address up-front issues related to working with patients to manage pain, along with tools to support clinicians. Examples include: • Opioid prescribing guidelines • Utilizing shared decision making with patients • Screening for risk factors • Alternative therapies to treat chronic pain The toolkit also highlights considerations for special populations such as adolescents, young adults, and the elderly. Related webinars have

MAY 2019 MINNESOTA PHYSICIAN

Unused medication increases risk of misuse To avoid repeat refills or after-hour requests, some clinicians prefer to offer prescriptions to cover longer periods. A Mayo Clinic study presented to the 2018 annual meeting of the American Surgical Association showed that nearly one-third of their patients didn’t use any of the prescribed opioids after surgery, and over 60 percent of the total pills went unused. However, only 8 percent of patients properly disposed of the remaining medication, resulting in a lot of unused medication at risk of improper use or diversion. A Johns Hopkins study shared at the 2017 annual meeting of the American

Pain Society also showed that patients were not given information on how to safely store or dispose of leftover medications.

• Alcohol use

• Benzodiazepines and other drug use Prescribers can play an important role in reducing the amount of • Clearance and metabolism of the drug unused opioids available for diversion. Prescribing the lowest therapeutic • Delirium, dementia, and falls risk dose needed is one part; educating patients on safe • Psychiatric comorbidities storage and disposal is also important. While the vast majority of opioid users do not go on to use • Query the Prescription Monitoring Program illicit drugs, NIH data estimates that 86 percent • Respiratory insufficiency and sleep apnea of injection drug users got prescription opioids Adults with mental health • Safe driving, work, storage, and disposal from their family or friends. There are disposal kiosks at many Minnesota pharmacies, and the state Attorney General’s Office promotes the Dose of Reality program, which helps people find nearby disposal locations.

conditions receive over 50 percent of opioid prescriptions.

Shared decision making Managing patient expectations can make the entire process work better for both the patient and the provider. Health care providers integrate shared decision making in large and small ways in almost every patient encounter. When prescribing opioids for the first time, a clear, honest discussion needs to happen to help patients understand the risks and benefits of the medications you are suggesting. Be clear that the prescription is for an opioid—patients may be aware of opioid risks, but may not be familiar with the name of a given medication.

Determining whether a patient is on the Restricted Recipient Program

Like most states, Minnesota has a Prescription Monitoring Program (PMP) to assist prescribers in safely managing their patients. While all Minnesota prescribers are required to register for the program, they are not required to check it, so some patients may slip through the cracks. Because the PMP cannot be easily accessed through most medical records, its use has been limited, but it is important to ensure that at-risk patients are not receiving medications from other sources. In addition, Minnesota has a Restricted Recipient Program for recipients of Minnesota Health Care programs (Medicaid) who are suspected of misusing services. Patients may be limited to one medical provider and/or Opioid prescribing to page 224

Some patients may expect medications to completely eliminate any pain as they recover from an injury or surgery, but it is important for them to understand that pain is a normal part of healing and can even be the best indicator of their recovery. Make sure patients are aware of what their pain expectations should be.

Resources to manage patient expectations All treatment options should be laid out for the patient, from non-opioid pharmacological options to other therapies that may not involve medications. The risks and benefits of all options should be understood. And an honest discussion of limits is important—clarify whether the patient can expect refills, and you will make future discussions much easier. The toolkit offers additional resources to support these discussions, such as patient education and a sample opioid/pain management agreement.

Tools to screen for risk factors In addition to discussing the patient’s physical pain, it is important to assess their risk for mental health issues and addiction. A study by Matthew Davis, published in the July-August 2017 edition of the Journal of the Board of Family Medicine, showed that adults with mental health conditions receive over 50 percent of opioid prescriptions, and use opioids at a much higher rate than the general population. People dealing with depression or other mental health issues may selfmedicate with drugs or alcohol, and people in pain may also experience depression. While a formal assessment tool may not be necessary for all new prescriptions for acute pain, clinicians should always screen for the patient’s history of substance use disorder, mental health issues, and depression. Anxiety and depression can also warp pain perceptions. The Opioid Toolkit offers suggestions on strategies and screening tools for clinicians, including the ICSI mnemonic to aid in the evaluation of risk factors—ABCDPQRS:

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MINNESOTA PHYSICIAN MAY 2019

3Opioid prescribing from page 21 one pharmacy for their care. Clinicians can consult the MN-ITS Program to determine if a patient is on this program. These and other safety resources are included in the toolkit.

Alternative therapies to address the multiple causes of chronic pain CELEBRATING THE MUSIC OF LATIN AMERICA Jul 6 - Aug 3

La Pasión según San Marcos

La Pasión según San Marcos (The Passion According to St. Mark)

Fri Aug 2 & Sat Aug 3 8pm Energized by the spirit of Afro-Cuban music, bossa nova, tango, rumba and mambo, Osvaldo Golijov brings the rich tradition of Latin American music to his interpretation of the final days in the life of Jesus Christ as described in the Bible’s Gospel of Mark. This performance features the Minnesota Orchestra and brings together international soloists, choristers and soloists from Border CrosSing and the Minnesota Chorale.

Many patients prefer to try non-opioid treatments for pain before supplementing with medication, or in conjunction with painkillers. For others, alternative therapies used in conjunction with traditional medical treatments create a more effective program to help cope more successfully with their pain. Effective alternative therapies include various cognitive behavior therapies, traditional rehabilitation therapies (physical therapy, transcutaneous electrical nerve stimulation, exercise, massage, and even simple hot/cold treatments), as well as complementary or integrative medicine such as acupuncture, tai chi, yoga, or meditation. Clinicians should educate themselves about potential alternatives and discuss the patient’s preferences using a patient-centered approach. Alternative therapies may be covered by a patient’s insurance but often are not, so it is important for them to contact their plan member services to verify coverage. To assist clinicians in determining what alternative therapies may be covered by Medicaid, the project has created a Minnesota Medicaid Benefits Coverage Grid, located on the project page and updated annually on the Stratis Health website at www.stratishealth.org/pip/opioids.html. There are resources in the Opioid Toolkit for physicians to educate themselves about alternative therapies, as well as resources to share with patients. In addition to the toolkit, health plans are taking varied approaches to the issue with their networks and members. Some are involved with ICSI’s MN Health Collaborative. Other plans are doing direct outreach and education to individual members or monitoring prescription rates among their network providers. As this Opioid QI project moves forward, look for more webinars on topics relevant to this issue in Minnesota, such as the impact on rural communities and the elderly. Visit the project page at www.stratishealth.org/ pip/opioids.html to see upcoming webinars or to view past ones.

Summing up

Tickets: $30-$97 F E AT U R I N G

Minnesota Orchestra María Guinand, conductor Marcela Lorca, stage director Jessica Rivera, soprano Luciana Souza, mezzo Reynaldo González-Fernández, vocalist and dancer Ahmed Anzaldúa, choral preparation Border CrosSing Minnesota Chorale

Balancing the desire of patients to minimize discomfort with the need to manage medications and utilize best practice makes pain management a complicated task for clinicians. Utilizing collaborative skills to educate patients and developing recommendations to help them make the best decisions are key to successful outcomes. Screening for risk factors prior to prescribing, and educating about proper disposal, make safety a priority. We have already seen improvements in prescribing practices in Minnesota. From 2016–2017, DHS noted a reduction of approximately 10 percent in opioid prescriptions. This issue reaches into virtually every medical setting in the state. By working together and following common sense practices, we will see this trend continue, resulting in safer health care.

María Guinand

Andrew R. Zinkel, MD, MBA, FACEP, FAAEM, is an associate medical

612-371-5656 / minnesotaorchestra.org/sommerfest Orchestra Hall /

director of quality at HealthPartners health plan and a practicing ER physician at Regions Hospital.

Música Juntos is sponsored by

Patty Graham is a senior quality consultant at HealthPartners.

MAY 2019 MINNESOTA PHYSICIAN

3The Minnesota NET-Works program from page 19

served as a co-principal investigator of the study. Dr. Sherwood’s research focuses on the development and evaluation of behavioral obesity prevention

across three years. Flexible amounts of intervention contact and channels of delivery may optimize results for families at different time points in their lives. Research that evaluates the effectiveness of varied combinations of intervention components and dose could be a useful approach to better understand how best to create family-optimized interventions.

and treatment interventions across the lifespan.

Sara Veblen-Mortenson, MSW, MPH, served as a co-investigator and project director of the study. She has 28 years of experience in the development, implementation, and evaluation of community-

A second important take-away finding from based randomized controlled trials and contributes the NET-Works study is that focusing on parents of Parents are vital agents skills in both public health project management in obesity prevention. preschool-aged children who are already overweight and intervention prevention research development, or obese is an effective strategy. Pediatric primary implementation, and evaluation. care providers should focus their efforts on overweight children who are at the highest risk for The authors would like to acknowledge the excess weight gain and higher-than-healthy body participating families for their contributions to the mass index. Parents may be more motivated to study, and the research staff team who contributed make family and household changes if their preschool-aged child is already to its implementation. overweight and perceived as having a significant health risk. Grant Funding: This research was supported by NIH award Recommendations for pediatric obesity intervention and follow-up care U01HD068990, with additional support from other members of the include working with parents to change the home environment and family Childhood Obesity Prevention and Treatment Research Consortium from routines associated with healthy food choices, screen time, and physical the National Heart, Lung, and Blood Institute, the Eunice Kennedy Shriver activity. Children who are overweight or obese, and children of racial/ National Institute of Child Health and Human Development, and the ethnic minorities, are at highest risk and should therefore be prioritized Office of Behavioral and Social Sciences Research at the National Institutes for resources related to child obesity prevention and treatment. Primary of Health. care provider organizations and physicians should work with communityClinical Trial Identifier: NCT01606891 serving organizations that already serve low-income, diverse families, such as early childhood and family education, through the public school systems; school district nurses and school administrators to affect food and physical education policies; and municipal civic bodies that create policies and ENGAN ASSOCIATES programs for building a supportive built environment for active transport and family-friendly leisure time activities. Several existing home visitation programs could be partnered with to implement a healthy family curriculum that focuses on food choices, physical activity, and screen time.

Conclusion A three-year, multi-component, multi-level, parent-targeted behavioral intervention was successful in decreasing child energy intake and television viewing time, but not in reducing BMI increases or increasing physical activity among preschool-aged children. Significant intervention effects on reducing BMI increases at three years were observed among Hispanic children and in children who were overweight or obese at baseline. Familylevel behavioral interventions may be most effective in children who are already overweight and when delivered through channels that are attractive to parents and at a dose that is tailored to optimize participation.

Creating Healing Environments for 40 Years

Simone A. French, PhD, professor of epidemiology and community health at the University of Minnesota School of Public Health, served as a co-principal investigator of the study. Dr. French has conducted NIH-funded communitybased obesity prevention interventions in worksites, schools, and homes for over 20 years.

Nancy E. Sherwood, PhD, associate professor in the division of epidemiology

“We wouldn’t hesitate to work with Engan Associates again.” (Matt Reinertson, Heartland Orthopedic Specialists)

and community health at the University of Minnesota School of Public Health,

MINNESOTA HEALTH CARE ROUNDTABLE

TH 50 SESSION

Consolidation in Health care Examining cost and quality issues Consolidation in health care is a necessary part of the evaluation of the industry. Just as with any microeconomic sector, there will be mergers, acquisitions, new partnerships, etc. Just as there is good cholesterol and bad cholesterol, there is good consolidation and bad consolidation. Let us start by explaining what we mean by health care consolidation. What should we think when we hear this term? MS. QUAM: Collaboration is our future. Collaboration is a good idea, and

maybe we should look at consolidation as a model of collaboration. There are combinations of every sort going on and more coming all the time. Physicians are consolidating in many ways. They are staying independent but then they are having a management company. They are becoming employees. They are changing who they consolidate with and maybe it is not just with family physicians, it is family physicians and another practice. DR. JENSEN: You can try to define consolidation, but it is helpful to look at the motivation. Sometimes the motivation is survival. Sometimes it is greed. Sometimes it is power. We consolidate at many levels. Within a small office, you consolidate your efforts with your staff, and you do that for the good of the patient. One size does not fit all. In the world of consolidation, the patient frequently gets squeezed out in terms of what they want for medical care, and often the provider does as well. DR. DOWD: Consolidation can mean almost anything. A physician network

might be just a loose affiliation of physicians, until it comes time to talk to the insurance company, and then some people begin to describe it as a pricing cartel. On the other end of the continuum, you have organizations or provider entities that are actually in a hierarchy of ownership of services. What are some of the most important ways that health care is different from other industries? DR. KETOVER: Everybody who goes into health care sees it as a higher calling.

Even if you do not provide direct patient care, your work does make a difference to individuals, not just to systems. Consolidation is all about scale, bringing groups together so that you have more influence. That influence can be used economically to generate more revenue or to decrease expenses, but it should be used to create opportunities for what the collective group can do that individuals could not do: what types of services they can provide, what types of subspecialty areas, what types of additional customer service they can deliver. Much of the discussion about consolidation is about who is making

MAY 2019 MINNESOTA PHYSICIAN

Minnesota Physician Publishing’s 50th Minnesota Health Care Roundtable focused on the topic of Consolidation in Health Care: Examining cost and quality issues. Eight panelists and our moderator, Minnesota Physician Publisher Mike Starnes, met on Nov. 1, 2018, to discuss this topic. A transript of our Apr. 25, 2019, roundtable on Social Disparities in Health Care: Correcting the curve will appear in our August issue.

more money out of consolidation, instead of the benefit of consolidation to the community and to patients at large. DR. FIRKINS SMITH: There are probably not many industries where the

government has such an incredible role in how we purchase a specific thing. When you go to Target or Best Buy, you do not look at a television set and wonder how much it will cost or how it will run. And you don’t have the government pay for it. Essentially, that is what happens with a lot of our health care. Patients do not always understand exactly what they are buying, what is going to happen on the tail end, and how it will be paid for. DR. BARTHELL: In intensive care or emergent care, we are dealing with life and

death situations. People do not think about shopping around ahead of time, unlike primary care, where someone may ask a friend, “Do you have a referral for a good doctor?” I always tell families in the newborn intensive care unit that no one ever plans to have a baby in the NICU. It always catches people by surprise, and they are locked into the most convenient place to go. DR. DOWD: Cindy gave us a nice list of the features that distinguish health care from other products: market failures, poor information, restricted entry, and distorted prices. There are two views you can take on that. One is to say that, yes, that is right and there is nothing we can do about it. Markets cannot work and so we need to bring in the government to run the health care system. The other point of view is to say that, yes, it is true, but we could fix a lot of those problems if we had the will to do so.

JANE BARTHELL, MD, MSED,

is a neonatologist with more than 10 years of experience at Minnesota Neonatal Physicians, PA. Board-certified in neonatal and perinatal medicine by the American Board of Pediatrics, she received her MD from the University of Minnesota Medical School and completed a general pediatrics residency and neonatal fellowship at the University of Minnesota Medical Center.

SCOTT M. JENSEN, MD, is a senator (District 47) at the Minnesota Legislature, where he serves as vice chair of the Health and Human Services Finance and Policy Committee; a family physician at Catalyst Medical Clinic; and clinical associate professor at the University of Minnesota Medical School. He was named 2016 Minnesota Family Physician of the Year by the Minnesota Academy of Family Physicians.

BRYAN DOWD, PHD, is a professor in the Division of Health Policy and Management, School of Public Health, at the University of Minnesota. His research interests include markets for health insurance and health care services and econometric methods. His current research includes analysis of tiered clinic cost-sharing and evaluations of Next Generation and Vermont ACOs for CMS.

SCOTT R. KETOVER, MD, AGAF,

CINDY FIRKINS SMITH, MD, practices dermatology in Willmar. As clinical professor at the University of Minnesota and president of the Minnesota Medical Association, she advocated for collaboration across specialties, systems, and geographies. As president/CEO of ACMC Health, she led the independent systemâ&#x20AC;&#x2122;s integration with Rice Memorial Hospital and CentraCare Health.

LIZ QUAM is the executive director of the CDI Quality Institute, a nonprofit entity affiliated with the Center for Diagnostic Imaging (CDI). After serving as an assistant state health commissioner during the Clinton era, she founded a nonprofit devoted to finding health care coverage solutions for entrepreneurs and small businesses. She continues to serve a leadership role in health policy discussions.

TIMOTHY HERNANDEZ, MD,

LEN KAISER is the chief administrative officer for Entira Family Clinics, an independent family medicine organization serving the East Metro. He is also executive director for Community Health Network, an Accountable Care Organization that is a partnership between HealthEast Care System, Entira Family Clinics, and independent specialty providers. Prior to joining Entira he worked at HealthEast Care System.

is a family physician who has spent his career at Entira Family Clinics in West St. Paul. He is an adjunct associate professor at the University of Minnesota as well as medical director at Entira Family Clinics. He has served and continues to serve on many boards and committees, including the MN Community Measurement Board.

is president and CEO at Minnesota Gastroenterology, where he holds a leadership role with the Board of Directors. He is also the founding president and CEO of the Digestive Health Physicians Association. A Diplomate of the National Board of Medical Examiners, he is board-certified in internal medicine and gastroenterology.

Publisherâ&#x20AC;&#x2122;s note: Timothy Hernandez, MD, left midway through the panel discussion to deliver a baby. Len Kaiser, also of Entira Family Clinics, replaced him.

DR. HERNANDEZ: When I started practicing, we were pretty much a cottage

DR. KETOVER: In our practice, consolidation occurred in 1997 when

industry. You hung your shingle and you opened your door. Now we see the effect of third-party payers, not just in the government realm, but also in the commercial world, with the development of narrow networks which you can get boxed out of, depending on how those contracts are arranged and what sorts of promises are made by different provider groups and systems. It puts a lot of pressure on those of us in independent practice.

three groups came together. Since that time we have grown organically, from 30 physicians to our current 80 gastroenterologists. Our motivation for consolidating and growing our practice is that there are many subsubspecialties in gastroenterology to which a group of four, five, six, or 10 cannot devote the appropriate resources, because they are under-reimbursed. We have, throughout our history, been able to make choices to have some of our partners invest a significant amount of time providing clinical services, performing activities that are under-reimbursed for the amount of cognitive effort and skill that they put into them, but we as a collective partnership can subsidize those kinds of activities for the benefit of the population we serve.

Can anyone cite examples of things that have worked really well because of consolidation? DR. FIRKINS SMITH: In rural Minnesota, we have a number of very small

clinics and very highly stressed critical access hospitals. These health care providers or institutions are struggling on a day-to-day basis just to survive and to serve people. If they cease to exist, we will have a whole slew of rural Minnesotans who will not get health care or will not get health care close to home. We are endeavoring to work together or collaborate with the small health care facilities, critical access hospitals, individual or independent physician-owned clinics, and figure out the best collaborative model to sustain them and keep care close to home. The goal is, whenever possible, to keep the right care at the right place at the right time for the right sustainable cost. That is a prime example of the way consolidation needs to work.

DR. JENSEN: When Medicare and Medical Assistance came about in 1965,

many physicians were in their own independent clinics. At that time, you might have a chart for this patient and I might have a chart for this patient and, if we consolidated, we would have just one chart. We could collate the information and be less likely to duplicate tests. The motivation was truly noneconomic. After 1965, we had some pent-up demand that gave the whole system a jolt. Some people call those the golden years, because there were lots of services being provided, lots of business, and the payment was there. Then in the 1970s we saw runaway inflation in price and utilization, and we said that we cannot keep doing this. We tried the HMOs and other things. I went into medicine in 1970 and saw first-hand the catastrophic results of what a MINNESOTA PHYSICIAN MAY 2019

MINNESOTA HEALTH CARE ROUNDTABLE

capitated system could do to the motivation to take care of a patient. All of a sudden you were told that if you provide less care, you get more dollars. Can we look at a couple of ways that consolidation has created negative results? MS. QUAM: There are good studies that show that costs have gone up. As the

costs go up, it makes our whole system solution more difficult. DR. HERNANDEZ: In the past, referrals were based

on relationships. That is not always the best way or the most data-driven way to make referrals, but it had some value in terms of being able to engender trust. Now, as you get into various contractual arrangements, you are forced to use certain subspecialists and hospitals. Our group has always prided itself on trying to be low cost and high value. The larger consolidated groups form narrow networks with payers that we are boxed out of unless we agree to become closer, which usually means, at minimum, professional service arrangements or just plain acquisition. There are a number of threats to those of us in independent practice now. Consolidation has brought decision-making up to such a high level that it is out of our hands and there is not a lot that we can do about it. DR. KETOVER: As the hospital systems have

relationship. It is very important that we maintain it and make sure that, when we collaborate and/or integrate, those relationships are at the core of everything we do. DR. DOWD: The Robert Wood Johnson Foundation studied 11 hospital mergers, and found that prices went up in eight of them. Prices did not go down in the other three, they just did not go up. We have to remember that when you have concentration of supply in any industry, the prices do not just go up for the consolidating industries. When the industry itself becomes more consolidated, the prices go up for everybody, so this would be true for hospital mergers. It would be true of hospitals buying physician practices. Every time a hospital buys another practice, it is not enough money to warrant the attention of the FTC or the Justice Department, but if you have enough hospitals buying enough practices, then you end up with a very consolidated hospital industry and a very consolidated physician industry. MS. QUAM: I would like to talk about trust. As

Someone who can make a choice is going to be more engaged than someone who is told what to do.

a health system gets larger, patients feel more locked in. They cannot go someplace else, because the physician inside the health system says, â&#x20AC;&#x153;If you go to this therapist or this imaging provider, your records will not be a part of your medical record here in our system.â&#x20AC;? That might lead to duplicate tests or other duplicate care, and it also causes an erosion of trust. The patient goes home and Aunt Polly says the very best medical specialist is so-and-so, but the patient cannot get to that specialist. How do we allow patients to have second opinions?

grown in size and influence, they have become â&#x20AC;&#x201D; Jane Barthell, MD, MSEd more concerned with controlling leakage than with quality and patient outcomes. It has become important for those systems to keep that patient, service, and revenue within the system instead of looking around the community and asking, where is the best-qualified place Whether knowingly or unknowingly, federal reforms have contributed for my particular patient to get care? significantly to health care consolidation. Can anyone talk about how DR. BARTHELL: In vertical consolidation, when physicians are reporting to

administrators, it potentially can interfere with their loyalty to the patient. Independent providers can more easily focus their attention on the best quality care for their patients than they could if things were being dictated by people outside of that relationship. From a provider and patient level, are there problems that lead to a dehumanization of medical care? DR. JENSEN: We order tests that patients cannot afford. We do not bother

to check in with them, and by the time we are done ordering tests we have often damaged them physically or damaged them emotionally. That dehumanization of the relationship between patient and physician does not do our patients any good. DR. FIRKINS SMITH: Our physicians are really struggling, and unhappy physicians take bad care of patients and the relationship is dehumanized. One of the disruptors right now in medicine is a lot of virtual care, e-medicine. It is hard to have a humanistic relationship when you are doing so on your iPhone. Virtual medicine will probably be really good for select people under select circumstances at select times, but it can potentially dehumanize that

MAY 2019 MINNESOTA PHYSICIAN

that has played out? DR. KETOVER: One word is overhead. Hardly six months goes by where there is not another federal regulation requiring another form, another thing that has to be checked off in the electronic medical record, or another task that has to be performed in order to see the patient. The cumulative effect of all of this is that most providers spend more time in front of the electronic medical record than they do in front of the patient. The government has contributed to this by creating policies that layer one on top of the other. That creates a tremendous administrative expense for any organization, whether you are for profit, not-for-profit, consolidated or not. It takes a lot of time and support to get through all of those requirements and to do them correctly. DR. HERNANDEZ: I think about ACOs and their requirements. To win or lose

in an ACO, you have to consolidate or at least collaborate at a high level. The positive thing for those of us that are independent, single-specialty groups is that it has forced more structured conversations. Years and years ago, during those capitation days, we tried to do some very loose arrangements. We spoke with specialists about trying to manage populations from a cost standpoint, but the incentives were not built-in, the payment was not built-in, and it was pretty much all based on relationships. As great as that may be, it did not go

very far. You can argue about whether the ACO structure and form has been a good or a bad thing, but it has forced those consolidations. It forces primary to work with specialty, hospitalist to work with ambulatory, and everyone to play in the same sandbox. DR. JENSEN: If you are going to refer your patient for an MRI under your

own roof, it is going to increase your gross revenues, potentially decreasing your overhead and increasing the number of dollars that are going to come to your wallet. At some level, that is fee splitting. We have said that is okay in ACOs. We have said that monopolization and some of these consolidation moves are okay. We never used to say that. To me, the ACO is sort of a retooled HMO product that did not work very well a long time ago, but we are right back at it. Are there elements of health care delivery such as health insurance, PBMs, hospital and clinic systems, or pharmaceutical manufacturers that need to be kept apart as separate entities? DR. FIRKINS SMITH: Doesn’t it depend on their

they contract with providers, but we should be able to discover how much a knee replacement costs in St. Paul versus Owatonna. DR. BARTHELL: We also need transparency with outcomes. Anyone ought to

be able to look online and figure out which NICU has the best survival rate for infants born at certain gestational ages. People go to U.S. News and World Report and say, “Okay, this hospital is listed here, so this must be the best care,” but that is not really telling the picture that matters to families and that affects everyday life. The outcome measures for neonatology in the U.S. News and World Report rankings are blistering central line-associated infections, accidental extubations, babies who got the wrong breast milk, and babies who go home on breast milk. Those are important, but there is nothing about chronic lung disease of infancy, necrotizing enterocolitis, or retinopathy of prematurity. These are real diseases that affect long-term neurodevelopment of children. Someone who walks into a hospital and delivers a 26-weeker is going to have no insight on that and really can go nowhere online to find the best institution to take care of their baby at gestation.

motivation? I do not know that you can make a DR. HERNANDEZ: When MN Community blanket statement. If all of the organizations are Measurement develops their quality metrics In 2021, the average health insurgoing to consolidate for the purpose of cutting and cost metrics, they bring a wide variety ance premium will cross 50 percent out other entities or increasing their profit, of stakeholders to a neutral table: consumers of average household wage income. whatever their motives are, that is obviously or patients, employers, providers, payers, the bad. For instance, the Mayo Clinic is trying to Department of Health and Human Services, and —Bryan Dowd, PhD create a pharmaceutical company, and that is a the Minnesota Department of Health. We do not consolidation. But their motivation is not to necessarily come up with perfect solutions, but corner the market on pharmaceuticals. Their we do come up with proposals that at least have consolidation is to reduce costs. Isn’t that a good some consensus. That may be a model for trying idea? If the motivation is to provide the right care and to reduce cost and to drive some of these accountabilities, or at least to help us determine how to increase quality, I would be interested in hearing about that consolidation. measure the success or failure of consolidation efforts. What accountability should the big systems have? Who should they be accountable to? DR. KETOVER: They should be accountable to everyone: patients, stakeholders,

people who work for them, and the community at large. Our charge master, what we charge for our services, has been on our website for more than five years. I cannot find another institution in the United States that does that. That would be one place to start. You would at least have a chance of understanding what different institutions charge for the same service. The challenge is that the payer for the product is rarely the patient. They do pay out-of-pocket, but mostly it is third-party payment, either an employer or the government. Those institutions do not really care about transparency. The big insurance companies do not want transparency because that gets into how

DR. DOWD: A lot of our discussion has been about being accountable to

consumers. If you are not accountable to your consumers, your consumers might go someplace else to get their care. But there is a substantial number of very influential politicians and other people in the country who have not bought into that model at all. The model they have bought into views health care as a public utility that is run by the government. DR. JENSEN: MN Community Measurement says that to do a good job of treating depression, you have to get a PHQ-9 above such and such a number at time zero. At three to six months you have to do another PHQ-9. If the number isn’t better or the patient does not follow up, you get a black mark. We spend so much time trying to tabulate this data. We spent $14,000 last year to try to come up with the correct data so we could submit on whether

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or not we had done MN Community Measurement depression things. You are telling me that that is how we should hold accountability? I would think that maybe we could let the patient trust and decide, “Gee, Jensen, when I come to your clinic I always feel worse than I did before and I want to commit suicide.” Maybe they will find someone else. With this idea of having government take over one more layer, we are more and more distancing the patient. One of the issues when you are dealing with contracts that send the patient to preferred providers and narrow networks with restrictive formularies is that they might counteract good clinical practice. What do you do as a provider when you are looking down the barrel at that? DR. HERNANDEZ: We could spend two or

the health system’s top executives are being paid and on health outcomes. It is both measurement and then it is transparency on that measurement. Who can be an advocate for the interests of patients and physicians in an increasingly consolidated health care delivery system? DR. FIRKINS SMITH: Patients and physicians. That is the answer. When

it comes to these health systems, it is imperative that you have physician leadership or strong clinician leadership throughout the entire organization. There is data that suggests that physician-led organizations have higher quality and better outcomes, and I am all for having patient advocacy in there as well. We need to have a patient voice throughout the entire organization. MS. QUAM: A year or so ago there was a small

bill in Jefferson City, Missouri, that stated that three days talking about formularies and prior an order to deny a prior authorization request approvals. The contractual obligations and the required a health care physician licensed in the hoops that we have to run through and the state of Missouri. That is all it said. We had one systems that we have to build to work through lobbyist for all of the physician organizations, them and around them are so significant that and there were 18 health plan lobbyists in the sometimes you wonder, wouldn’t it be nice to room. It is not dissimilar here in Minnesota, have just one master and just one way of doing where there might not be that many bodies Physician-led organizations have it? That gets us down a whole trail of single payer sitting in the health committee meetings, that I do not necessarily advocate, but there higher quality and better outcomes. but there is this army of law firms behind the are some huge bureaucratic barriers that would insurance lobbyists. It becomes overwhelming, —Cindy Firkins Smith, MD be broken down. When I prescribe Suboxone even when you are doing your best and you or buprenorphine, it is not unusual to have know you are on high ground with whatever the the insurance company say, “Nope, we are not issue is for patients or physicians, because we are going to pay for that.” So we try like crazy to distorted in how advocacy happens under our find out which pill they will pay for and which current system. pharmacies they will be able to get it at. In the meantime patients suffer. DR. JENSEN: During the last two weeks of the 2017 session, there was one health system that wanted extra hospital beds. Throughout the entire How do we differentiate between good and bad consolidation? legislative session, we had never had any level of intensity like that. Twenty DR. BARTHELL: That gets back to motivation. You cannot argue that to 25 people descended, spent the whole day there. They were pulling us off consolidating in a rural area, where there is risk to some provider’s survival, the senate floor to talk to us over and over again about why they had to have is a bad thing. When you look in bigger areas where there is more choice and these hospital beds. Tony Lourey, a Democrat from Moose Lake, said we you see bigger institutions taking over more market power, then you start to should get an opinion from the Department of Health. The opinion from question whether consolidation is the right thing. the Department of Health said we could not justify it. Still the tug-of-war went on. It was in the 11th hour and in the end a compromise was hammered DR. JENSEN: If consolidation is occurring in an effort to create more out. What the systems, payers, and pharmaceuticals can unleash in terms of openness, that would be a good thing. If consolidation is occurring to cause lobbying power is intimidating. more opacity, that would be a bad thing. It does not take a rocket scientist to see when it is being done with the primary motivation being power, control, and increased revenues. We used to have the FTC ferreting out monopolies, and we had CMS concerned about self-referring and fee-splitting, but those have been sort of waived. In a lot of ways, it is the legislatures that have failed the system. We are the ones who maybe bought it hook, line, and sinker. Now we have narrow networks, patients displaced from the decision-making process, and patients who do not have a clue whether their first day in the hospital is going to cost $10,000 or $1,000. We need to start taking steps to stop this.

DR. FIRKINS SMITH: I agree with that, but if we walk away and say, “Oh,

MS. QUAM: We need measurement and transparency. There is no other way to

DR. DOWD: One study shows that in 2021, the average health insurance

identify motivations. We need measurement and transparency on how much

premium will cross 50 percent of average household wage income. In

MAY 2019 MINNESOTA PHYSICIAN

they’ve got all the money, they’ve got all the power, they’ve got all the people, we can’t do anything,” that is a useless attitude. I refuse to accept it. It took me 11 years to get tanning booth legislation passed in this state. Eleven years. It is up to us to be pit bulls when it comes to getting this stuff done. If the problem is the lobbyists and money, then change the law. Why do they get to have 100 lobbyists in the Capitol pulling on everybody’s ears? Why do they get to donate $100 million to the people who are running for office in order to have that kind of influence? Let’s change it.

2033, it will cross the entire household wage income. That just cannot happen. The optimism is that we won’t let it happen. The somewhat cynical viewpoint is that every household that the health care industry prices out of the health care market is another point on the demand curve for really disruptive innovation, and there are hungry people in the tech world who are working on disruptive innovation in health care. They are not thinking about innovative payment reform. They are thinking about innovative bypasses to the U.S. health care system. Part of the problem here is that there is a trust that health care organizations are altruistic in looking out for the best interest of consumers, but this may not always be the case. How do we address that? MR. KAISER: There has to be a way to measure

and create accountability for what is being said or what they are trying to do. When I think about the consolidations that happen within the market, I think about the statements that are made about the benefits that consolidation will create for the community. I never see any followup on how those benefits are actually achieved or how they have demonstrated the value of the consolidation. Having more follow-up after the consolidations and holding accountability around whether they follow up on the promises that they make when they get together and form these larger systems would be important.

Bigger and larger health systems have clearly not produced lower consumer costs or higher quality care. What needs to happen for this to be made clear and to effect change? DR. JENSEN: Over the last 50 years, we have taken the patient out of the equation, and I think many patients feel inadequate to being their own best champion. Somehow we have got to get patients to understand that they can say “no” to that angiogram. Almost 30 percent of our expenditures are related to low-value services that do not need to be done in order for us to optimize patient care. If you look at the data from the top 15 first-world countries, we perform more MRIs, CT scans, and coronary artery bypass grafts than anyone else. Price has certainly escalated, but utilization has inflated with some of these bigbuck procedures that are easy to do, and they play on the fears of the people. DR. KETOVER: It starts with the goals. All health

care organizations say “patients first.” But how many times do they ask how the decisions they make will affect the delivery and outcome of patient care? One big thing that is missing in this whole debate is the patient’s responsibility in their health. The best thing that I can do for There are a number of threats to those a patient is to say, “I’m going to reach in my of us in independent practice now. toolbox and recommend these three tools for you. —Timothy Hernandez, MD But I cannot make you use them. You have to be motivated and believe that this is going to help you.” There has to be an environment in which a MS. QUAM: You could start with the hospitals. physician can say to a patient, “I understand your Look at their charter, their nonprofit charter, anxiety and concern about your symptoms, but I and make sure that they are meeting it back to do not think you need the MRI today. Let’s wait measurement and transparency, especially as it relates to Medicaid. two weeks and see what happens.” Our system has evolved to the point where providers who do that are under-reimbursed relative to providers who just U.S. antitrust laws prevent collusive practices that restrain trade, check the box for the MRI. restrict mergers, lessen competition, and prohibit the creation of a monopoly and the abuse of monopoly power. These seem to be being run roughshod over. Who is going to enforce those? DR. DOWD: Most health economists would say they believe the Justice

Department has been asleep at the switch for the last 20 years. I think that is a little too harsh. The federal government has a limited budget, and so does the Justice Department. When they are going after Microsoft, that is a big deal. The health care industry is a big deal too, but they have got to make choices. I am not a lawyer, and so I am not able to say if there is some technical legal impediment to enforcement of the antitrust laws, but I sure hope someone could explain that to me, because otherwise I have got to conclude that the judges are just approaching gullible from the other side.

DR. FIRKINS SMITH: People often do not understand what real quality is.

I may have a patient who just had a knee replacement come in for skin disease. They rate the quality of their knee replacement on the appearance of their scar: “The surgeon did a really good job, look at that scar.” It is great to have a good scar, but the real quality is how does your knee work, how can you get around, are you having a good quality of life, is it functioning, is it going to get infected, is it going to work for five years, those kinds of things. I just read an article that said people do not actually search out health care for quality. They are far more likely to search based on a relationship or a recommendation, either by their physician or their next-door neighbor.

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If some of this needs to be addressed through legislation, what kind of data do we need to bring to the legislatures to make them aware of these issues?

Is there some irony in the fact that laws that were made to prevent physicians from colluding with each other have allowed payers to do just that?

MR. KAISER: There is a challenge with trying to get good data and

DR. KETOVER: In the process of renegotiating one of our contracts with a

agreement on what is good data. From a cost standpoint, we as an organization are constantly trying to find information about the highvalue partners that we should be working with. Who provides low cost and high quality? We get contradicting data from pretty much everybody, so it would be nice to have consistency.

commercial payer, they asked us to justify our request. They said, “Why don’t you share with us what you are being reimbursed by other payers?” I thought to myself, “You already have access to a lot of that information.” The insurers have each other’s information, but we do not. In another state, a provider group went on Craigslist and advertised that they would pay for the EOBs from patients for various procedures so that they could see how things were getting paid for by different payers. As a provider organization it is rare to have extensive knowledge of reimbursement differences in your market, so your only leverage in dealing with insurance companies is either to accept the contract or be out-of-network.

DR. JENSEN: We have a lot of services ordered because some studies indicate that one out of every four dollars spent in health care is based on some form of defensive medicine intended to avoid litigation. I do not think this will be solved by trying to get legislators to understand the data, because they will be influenced by the biggest category of lobbyists in the 11th hour. We need to have people like this audience who are well-spoken and understand the system to keep hammering. You need to hold your legislators accountable. You are the stakeholders. DR. DOWD: Walt McClure once said that the

best way to improve measurements systems is to implement measurement systems. If you do that, you will immediately hear what all the problems are with them. But with MN Community Measurement and the all-payer claims database, we are further ahead than any other state in the country. If we cannot do something on the consumer path of health care reform, nobody else can do it.

You need to hold your legislators accountable. You are the stakeholders.

Antitrust laws use the word “cartel” to describe an entity that controls manufacturer supply and access to a market sector and limits or removes competition. Over time we have steadily enacted policies that effectively, if not intentionally, exempt health care delivery from these public protections. What needs to happen for this to change? MS. QUAM: There was an article in the Wall Street Journal about “secret

deals” involving an agreement for the insurer not to steer away from a health plan because the health plan took a 1 percent inpatient rate reduction. The insurer might be promoting something to the self-insured clients, but actually there is a “secret deal” between a health system and the insurer. Those kinds of arrangements need to be transparent, too. It is not just the pricing for each individual patient. If this is the nonprofit sector, and most hospitals are, then is there something we should be doing even with those contracts where there are certain specific things that they have to reveal? DR. DOWD: The good news from the industrial organizations literature is that the same greed that forms the cartel also gives the efficient members an incentive to break the cartel. We just have to give them a reason, make it worth their while, and pay them to break the cartel.

MAY 2019 MINNESOTA PHYSICIAN

DR. FIRKINS SMITH: That is a significant problem for those of us in rural areas. When patients are out-of-network in urban areas, they can go down the street. When we are out-of-network, where do they go? They either pay huge increases for their care, or they drive to the Twin Cities.

MS. QUAM: Sometimes it is called out-ofnetwork, sometimes called “surprise billing,” which is causing even more problems. We have a really decent bill in Minnesota, but at the federal level, Senator Cassidy is offering a bill that the insurers are trying to hijack so that if you are outof-network, you are only paid a percentage of Medicare. In California, I believe it is 120 percent of Medicare.

—Scott M. Jensen, MD

Increasing health care consolidation is contributing directly to a serious public health issue, specifically the rising number of individuals with health care disparities. Let’s talk about this a little bit and ways that this can be addressed. DR. FIRKINS SMITH: I would need to know why we think that consolidation is

increasing health care disparities. One of the reasons that we consolidated in rural Minnesota is that our population is well over 50 percent Medicare and Medicaid, and a lot of our population is very poor, under-represented, and has a lot of social disparities. Our concern was that if we did not come together as a larger organization and create some scale and address these problems, we were going to have to abandon those patients, and we were unwilling to do that. For us, consolidation was an answer to address and deal with social disparities. You are completely right. There is good consolidation and bad consolidation. Liz, you cited an example of this being a chain reaction: when one organization owns the insurance and can price the product out of reach of a certain number of individuals, it has downstream effects. How does that work? MS. QUAM: Trust is a really big thing, especially for some populations, and

if you already do not trust the health care system, going into a big white

sterile hospital setting is not a good thing. You just stay away. Studies show that across the country. We want multiple options for access, especially for vulnerable populations of all different kinds. If we only have one big hospital door every 50 miles, we contribute to that disparity. DR. JENSEN: Social disparities do occur in the consolidation movement when

people to live in the community. Providing good health care does nothing for the people in our community if we bankrupt them in the process, and I would say the same for the employers in the community. Part of the disruption in rural health care will be working directly with the payers. By that I mean the employers, because nongovernmental payers are primarily employers.

facility fees are all of a sudden a new part of the plan. Patients do not see it coming, and people who suffer the adverse consequences of social disparities often do not have the skill set to negotiate or push back. I had a patient who brought in an EOB and his bill was $70,000. By the time the insurance company had adjudicated it, the $70,000 list price had been brought down to $12,000, and the patient had to pay $40. He said, “Doc, how can a bill be $70,000 and be brought down to $12,000?” I said, “I think it happens with some frequency.” But if there is anybody who does not get that advantage, it is a person without insurance and with no advocate, nobody negotiating on their behalf, and they are stuck with a $70,000 bill. They go to the hospital and they plead, beg, borrow, get on their knees, and they finally get a reduction from $70,000 to $65,000. This is the way social disparity affects us so profoundly. Most providers spend more time in In the first half, we mentioned the tiered front of the electronic medical record system. Let’s talk about that a little bit. than they do in front of the patient. DR. DOWD: Minnesota state employees choose a

Also in the rural setting, there are not a lot of other choices that the community has to go for care. DR. FIRKINS SMITH: Certainly people can drive,

and other organizations might come in. There is not a lot of profit in doing that because the vast majority of our patients, well more than 50 percent, are government paid, low reimbursed. One of my concerns is that when disruptors hit our market they are going to go after people that have money, and we now use people that can pay for health insurance and employers that can pay for health insurance to cost-share those that cannot. So when they start siphoning off the ones that have the better reimbursement, how are we going to be able to cost-share those costs for the people that have very low reimbursement? DR. KETOVER: There are maybe a handful of

—Scott R. Ketover, MD, AGAF

primary care clinic placed by the state into one of four cost-sharing tiers. The primary care clinics then serve as gatekeepers and direct your referrals to hospitals and to specialists. That system gives both the providers and the consumers an incentive to choose efficient providers. If you just stick the consumer in a high-deductible health plan, they cut back on the care they should get. If you just give them information but no incentive to act on it, then nothing happens. One study that just came out in the American Journal of Health Economics involved Safeway. They gave consumers information about quality of care. Nothing happened. Then they tacked on reference pricing, and they started getting 29 percent savings on their total health insurance cost with no difference in quality. You have got to give both the consumers and the providers an incentive to be more efficient. To address the issues in the rural setting, would it be possible for the clinics to negotiate directly with employers? DR. FIRKINS SMITH: We would like to do a lot with employers. They are

the lifeblood of our community. People and employers are what allow

organizations in the country that could survive on 100 percent Medicare rates. That is a fallacy when we talk about Medicare for all. There are many institutions here in the Twin Cities that would disappear if all they were paid was Medicare rates. We need to address that. It is the commercial insurance reimbursement that subsidizes the insufficient payments from Medicare and Medicaid.

DR. JENSEN: Consider the concept of direct primary care, especially if you had a core package of catastrophic coverage that linked in direct primary care. You really do not have the clinic and physicians being exposed to loss. At the worst, they would be out time, but they are generally going to be inclined to be very efficient. They will do whatever they can to get that patient plugged into an ideal setting. The direct primary care model has some bugs in it, but I think it is a good idea, and it could be good for outstate Minnesota. DR. FIRKINS SMITH: One of the problems with direct primary care is that it has

generally been offered for people that can afford that extra monthly payment. A lot of our patients just do not have it. We need to find a way to implement that kind of model for the people that do not have that additional money.

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What are the most important things we need to do to stop consolidation in health care that does not benefit patients and ensure consolidation practices that do benefit patients? MR. KAISER: To ensure appropriate consolidation, we need to identify the value when consolidation is occurring. If there is consolidation that is ongoing, what does it do? We are almost to a point now where consolidation is not a value add, it is more a response to current systems failing. How do we create and support the established existing systems that we have today to make sure that groups that are not part of large systems, who want to remain independent and viable, have those resources and support in order to stay viable in the long term?

going to have to change in order to ensure health care delivery with the best value, the best outcomes, and the lowest cost in the future. When people want to consolidate, check the motives, check the intent, and then ask them how they are going to address, in an innovative way, the change that needs to happen to deliver care and ensure future health care outcomes. And then I would hold people to the fire. I really like the idea of transparency. We are dreadfully lacking transparency in medicine. DR. DOWD: In the past I would have said to

enforce the antitrust laws, but I think it may be too late for that. What I would say now is that we have to redesign the system so we reward efficiency instead of penalizing it. MS. QUAM: I do not think we can get where

DR. BARTHELL: To keep consolidation where

it is most helpful, we should acknowledge that studies in psychology, sociology, and economics show that people’s best engagement and best performance happens when there is self-direction. Autonomy, mastery, and sense of purpose are what drive human behavior. Choice is also part of what engages patients. Someone who can make a choice is going to be more engaged than someone who is told exactly what to do. It is the same with providers. When providers can direct what they think is the best care for their patients, they are going to be more invested.

As a health system gets larger, patients feel more locked in. They cannot go someplace else.

DR. KETOVER: We have to bring the patient back

into this, and be an active part of the transition to value-based care. When assessing the value of future consolidation, we need to understand the motivation driving the potential consolidation. What is the goal of the consolidation? Is it reactionary to a market where you need to have scale to survive? Is it proactive in a market where you want to have scale so you can control the market? I do not know that we can legislate good intent, nor can we go back and have penalties if the good intent does not produce a community benefit, but it certainly should be more of the discussion. When organizations, especially large organizations, are talking about consolidation, they ought to at least be challenged by having the community ask, “How will this benefit us? We know how it will decrease your expenses and maybe increase revenue, but how will the community benefit from this consolidation? DR. FIRKINS SMITH: We need to look to the future as well. A lot of

consolidation has been done as a reaction to the changing health care environment, and a lot of people have bemoaned it, wishing for things to stay the same. The problem is that things cannot stay the same. We are

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—Liz Quam

we need to go without intraoperability as it relates to patients going through the health care mega system. I think there is a disruptor coming. If you take a look at Apple Health, see where that might go, you do not have to worry about HIPAA. It is the patient who is clicking on “send this record” wherever the patient wants it to go. That is an open API, and that is coming. Medtronic has a product called Bind that shows pricing, hopefully quality too, again on your phone through an API. They are talking about it in Washington. Everybody knows what a mess Washington is, but if you pay attention to that, I think it will give you hope because it may allow the patient to begin directing his or her care again. DR. JENSEN: Determining whether consolidation

is good or bad is a dicey proposition. If we can demonstrate that consolidation is truly for patient ease, patient quality, and patient understanding and there is no adverse price impact on this—that it is not being done to add facility fees on to things—then I think it is justifiable. I do not think we can give up on enforcing patient protection laws. We have government agencies already in existence that have the ability to discern whether or not this a monopoly, fee splitting, or self-referral. In the early 2000s, Mike Hatch took aim at Allina and Medica and said, “Break it up.” Do we have any systems in place around here today that mirror what he broke up in the early 2000s? I do not think anybody in this room would have too much difficulty coming up with a few examples. If we are going to selectively enforce the laws and make special exemptions, we are just going to have more and more problems.

3Surviving a stroke from page 17

health care, we want, need, and deserve the same empathy, explanations, reassurance, and time from you as your other patients.

restrictions on the hospital menu), we couldn’t shower when we wanted Closing thoughts (public shower down the hall), we couldn’t use the restroom when we We are grateful for the many caring nurses, doctors, physical and occupational wanted to (need to monitor input/output), and therapists, and food service and housekeeping staff we couldn’t leave the room (risk of flu exposure). who took care of us. We will take the lessons we’ve Being in a hospital bed can make you feel like a learned from our experiences in the hospital into the caged animal at times. Therefore, when there are care we provide our patients every day. As shocking decisions we can be involved in, we appreciate being as our diagnoses and subsequent hospitalizations part of the discussion. Similarly, we appreciate your We need another quote here were, they have made us more empathic providers engaging our family members in our care when please and helped us relate better to our patients. possible. We were both fortunate to have supportive family members and friends with us for most of our Michelle D. Sherman, PhD, LP, ABPP, is a professor hospital stays. When you help our support network in the Department of Family Medicine and Community (e.g., answering their questions, getting them a Health at the University of Minnesota. A licensed blanket), you help us as patients. Please treat us as patients, not as providers or colleagues. When you’re taking care of health care professionals, please remember that we are now your patient. When sitting in a hospital bed, we’re not functioning as a provider. We are accustomed to being in control and making the treatment recommendations; we are frightened by the diagnosis (or diagnostic uncertainty) and scared to be in the vulnerable role of patient. After all, “we” aren’t supposed to get sick! We both remember thinking, “I cannot be admitted to the hospital tonight—I’ve got charts to close and patients to see!” Even though we have degrees behind our names and also work in

clinical psychologist, she directs the behavioral health

program at the University of Minnesota’s North Memorial Family Medicine Residency Program.

LuAnn Kibira, APRN, NP, is a nurse practitioner at Broadway Family Medicine, a University of Minnesota Physicians clinic in North Minneapolis. Her medical interest is women’s health.

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3“Stark” legislation and regulation from page 15 Each of the words in quotations has a specific whether it applies for Stark purposes. Second, if the Stark Law does apply, the next question is whether the arrangement fits squarely into an exception. There are numerous exceptions to the Stark Law, and a Stark analysis will focus on the tests specific to the particular exception that might be applicable to the arrangement. Some commonly relied upon exceptions are for: 1) bona fide employment, 2) personal services, 3) leases, 4) medical staff incidental benefits, and 5) non-monetary compensation.

under the Stark Law and the referral requirement is in writing and subject to: 1) patient choice, 2) third-party payer determination of provider, and definition or test as to 3) the physician’s judgment regarding the patient’s best medical interests. See 42 C.F.R. § 411.354(d)(4). Further, the required referrals must relate to the physician’s services that are covered in the arrangement, and the referral requirement must be “reasonably necessary to effectuate the legitimate business purposes” of the arrangement. If the arrangement is structured appropriately, it can be The depth and breadth of Stark-compliant—but, like everything else with these regulations ... are a Stark, there is a lot to consider. far cry from the “bright lines”

that Congress intended.

Third, if the arrangement satisfies the technical requirements of an exception, will it stand up to scrutiny of: 1) fair market value, 2) commercial reasonableness, and 3) no relation to volume or value of referrals. Usually when we see large verdicts or settlements, it is not because of a technical violation, but rather because the arrangement has an issue in this area. In one instance (United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc.), parties eventually settled for more than $72 million after a $237 million judgment. In the case of health care institutions that require their employed physicians to refer to onsite facilities, the referral requirement will not be a Stark violation if the physicians meet the bona fide employee exception

The depth and breadth of these regulations can be difficult for even the most experienced lawyers to navigate and are a far cry from the “bright lines” that Congress intended for providers to use to selfregulate when the law was initially enacted.

How can we fix it? One option that has been considered is to follow the model used for the MSSP program and other CMMI programs and extend waivers for fraud and abuse laws to participation in commercial programs involving providers taking financial risk or participating in clinical integration networks. The aforementioned waivers were extended in the MSSP and CMMI programs because those programs discourage overutilization. Extending these waivers to commercial arrangements that also discourage overutilization would further CMS’ goals of reducing regulatory burdens on providers and incentivizing the movement toward value-based care. There need to be some guidelines as to which commercial arrangements should qualify for the waivers. Fortunately, there is already a body of law that analyzes this issue. The Federal Trade Commission (FTC) and the Department of Justice issued guidance back in 1996, evaluating clinical integration and financial integration amongst providers as part of the analysis of whether such arrangements violate the Sherman Antitrust Act of 1890 (see www.tinyurl.com/mp-antitrust).

Helping physicians communicate with physicians for over 30 years. MINNESOTA

AUGUST 2018

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXII, No. 05

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

niversity of Minnesota Health is now among the few selected centers in the nation to offer two new immunotherapy drugs for the treatment of diffuse large B-cell lymphoma. Both drugs—Yescarta and Kymriah—are part of an emerging class of treatments, called CAR T-cell therapies, that harness the power of a patient’s own immune system to eliminate cancer cells.

Physician/employer direct contracting

CAR T-cell therapy involves drawing blood from patients and separating out the T cells. Using a disarmed virus, the patient’s own T cells are genetically engineered to produce chimeric antigen receptors, or CARs, that allow them to recognize and attach to a specific protein, or antigen, on tumor cells. This process takes place in a laboratory and takes about 14 days. After receiving the modification, the engineered CAR-T cells are infused into the patient, where they recognize and attack cancer cells. Kymriah received initial FDA approval in 2017 for the treatment of pediatric acute lymphoblastic leukemia. CAR T-cell therapy to page 144

Advertising in Minnesota Physician is, by far, the most cost-effective method of getting your message in front of the over 17,000 doctors licensed to practice in Minnesota. Among the many ways we can help your practice: •

Exploring new potential BY MICK HANNAFIN

ith the continuing escalation of health care costs, large and midsized selfinsured employers are once again looking for an edge to manage their medical plan costs and their bottom line. They understand that they are ultimately funding health care as they pay for their population’s claims.

•

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

•

Share new diagnostic and therapeutic advances Develop and enhance referral networks Recruit a new physician associate

Advertise! IN MINNESOTA PHYSICIAN www.mppub.com

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MAY 2019 MINNESOTA PHYSICIAN

(612) 728-8600

The same criteria used by the FTC in determining whether an arrangement is allowable under antitrust law would apply in determining whether the arrangement is appropriate for receiving a waiver of the fraud and abuse laws. As many commercial arrangements involving financial integration and clinical integration already require analysis to ensure compliance with antitrust law, requiring the same analysis for determination of whether the arrangement should qualify for fraud and abuse waivers would have a minimal burden on providers. Antonio “Tony” Fricano, JD, is special counsel at Gray Plant Mooty and specializes in health care regulatory law. He was previously associate general counsel and the MSSP ACO compliance officer for the largest health system in Illinois, based out of Chicago. Mr. Fricano has reviewed and advised on hundreds of potential Stark violations and has experience working through the disclosure process with CMS and the U.S. Department of Health and Human Services’ Office of Inspector General. He was a member of the Loyola Law Journal and a Fellow in the Institute for Consumer Law and Antitrust Studies.

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

Urgent Care Physicians HEAL. TEACH. LEAD.

At HealthPartners, we are focused on health as it could be, affordability as it must be, and relationships built on trust. Recognized once again in Minnesota Physician Publishing’s 100 Influential Health Care Leaders, we are proud of our extraordinary physicians and their contribution to the care and service of the people of the Minneapolis/St. Paul area and beyond. As an Urgent Care Physician with HealthPartners, you’ll enjoy: • Being part of a large, integrated organization that includes many specialties; if you have a question, simply pick up the phone and speak directly with a specialty physician • Flexibility to suit your lifestyle that includes expanded day and evening hours, full day options providing more hours for FTE and less days on service • An updated competitive salary and benefits package, including paid malpractice HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. Find an exciting, rewarding practice to complement all the passions in your life. Apply online at healthpartners.com/careers or contact Maly at 952-883-5425 or maly.p.yang@healthpartners.com. EOE

For more information, contact TSgt James Simpkins 402-292-1815 x102 james.simpkins.1@us.af.mil or visit airforce.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 2019

3Social engineering from page 13

• Refrain from opening links or attachments in emails from unknown sources.

Notify the local FBI office and/or file a complaint with IC3 (www. IC3.gov). Notify your insurance carrier to determine coverage. Recovery will almost always require the help of outside experts. Education

• Involve your manager if you have any doubts or concerns. • Do not use unknown or potentially compromised thumb drives that might contain malware. • Require ID badges to be worn; inconsistent enforcement allows a social engineer to merely say they forgot their ID badge.

Provide all employees with ongoing education to combat these threats. Consider the following: • Provide explanations and examples of the social engineering tactics currently being used by cybercriminals, particularly in the health care sector.

Data breaches occurred in 85 percent of large health care organization’s systems.

• Exercise vigilance regarding emails, unsolicited phone calls, or in-person interactions that attempt to get them to reveal personal or sensitive information, or that require going to an unfamiliar website or installing an unfamiliar program. Do not be afraid to question and/or challenge strangers or unusual requests, and always verify the identity of the requestor rather than taking people at their word. • Be wary of unsolicited postal mail and unexpected emails, especially if they are requesting an urgent action. Always verify unsolicited messages through a different means, such as a phone call or face-to-face conversation.

Summing up

Cybercriminals are becoming increasingly sophisticated, and health care is a prime target. Assess the security of your computer systems and enhance them as needed. Train your employees on an ongoing basis. Develop and practice contingency plans for these attacks. Given the scope and impact of the threats posed by modern cybercriminals, consider retaining outside security support as needed. Ginny Adams, RN, BSN, MPH, CPHRM, is a senior risk consultant for

Coverys, a medical professional liability insurance company. She has a background in critical care nursing, nursing administration, performance improvement, regulatory compliance, and risk management.

Carris Health is the perfect match “I found the perfect match with Carris Health.” Dr. Cindy Smith, Co-CEO & President of Carris Health

Carris Health is a multi-specialty health network located in west central and southwest Minnesota. Carris Health 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 • Orthopedic Surgery

• Psychiatry • Pulmonary/ Critical Care • Rheumatology • Urology

Loan repayment assistance available.

FOR MORE INFORMATION: Shana Zahrbock, Physician Recruitment | Shana.Zahrbock@carrishealth.com | (320) 231-6353 | acmc.com

Carris Health is an innovative health care system committed to reinventing rural health care in West Central and Southwest Minnesota. Carris Health was formed in January 2018 and is part of CentraCare Health. Visit www.carrishealth.com for more information.

MAY 2019 MINNESOTA PHYSICIAN

Urgent Care Physicians HEAL. TEACH. LEAD.

SHARE YOUR INSPIRATION.

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

Learn more at healthcare.goarmy.com/nz72

Change Lives WORK AT THE U Boynton Health is a national leader in college student health. We serve the University of Minnesota, delivering comprehensive health care services with a public health approach to campus well-being. Our patients are motivated and diverse undergraduate, graduate, and international students, faculty, and staff. On campus, you will have access to cultural and athletic events and a rich academic environment. Boynton is readily accessible by transit, biking, and walking. With no evening, weekend, or on-call hours, our physicians find exceptional work/life balance.

PRIMARY CARE PHYSICIAN Boynton Health is hiring a primary care physician to join our talented staff, appointment 80–100% FTE. We have in-house mental health, pharmacy, physical therapy, eye clinic, lab, x-ray, and other services to provide holistic care to our patients. We offer competitive salary, excellent and affordable health benefits, University-paid contributions to your retirement account, 22 paid vacation days per year as well as sick leave and 11 paid holidays. Reduced eligible tuition 75%–100%. Veterinary insurance. No weekends! No calls!

To learn more, contact Michele Senenfelder, Human Resources Generalist, 612-301-2166, msenenfe@umn.edu. Apply online at https://hr.myu.umn.edu/jobs/ext/329054. The University of Minnesota is an equal opportunity educator and employer.

410 Church Street SE, Minneapolis, MN 55455 • 612-625-8400 • boynton.umn.edu MINNESOTA PHYSICIAN MAY 2019

3Change management from page 7

• Choose to always move forward. Embracing change is not optional, it’s a requirement to survival. Phrases like “If not this, then what?” help people consider new options when they are stuck.

Infusing change management with collaboration Change management may be difficult to tackle within many health care organizations where physicians and staff are overworked, overwhelmed, or even burned out. An unusual but effective tool that has proven useful involves applying the rules of improvisational arts to quality improvement. In ICSI’s “Prime the Pump” workshop series, physicians and health care staff are invited to re-engage with change management through the collaborative framework of improv. Anyone who has watched the popular show “Whose Line Is It Anyway,” listened to jazz, or seen a performance by Stevie Ray or Brave New Workshop is familiar with improv. Watching successful improv is to see a group of people creating a safe, supportive environment where exceptional teamwork is employed to address a challenge together. Practicing the principles of improv can help drive collaboration within everyday work scenarios. Improv principles map beautifully to the process of change management, which requires an open, learning-based environment. Improv has a performance style with many layers of complexity, but these few key components of improv can be used to effectively create a collaborative environment for change management and conducting small tests of change: • Always say “Yes, and…” rather than “No” or “But” to any idea. This honors and validates others’ contributions, creating a supportive environment for new ideas to develop and thrive.

• Make your partners look good. Encourage participants to see themselves as interconnected and dependent on each other for success. • Genuinely listen and support others by discontinuing habits of negating, ignoring, or refusing ideas. Physicians who have participated in ICSI’s workshop Prime the Pump: Activate the Team, Accelerate Improvement often report back that they’ve learned new ways to collaborate with their staff and lead teams to co-create stronger, more positive change. Participants feel much safer making suggestions, and the atmosphere of teamwork that improv brings presents change management in a supportive, positive, and, often, joyful light.

Conclusion Change management in health care needs a makeover. Physicians can support this by using the four steps to engagement. Clarifying the “what,” team ownership of the “how,” and embracing ideas and testing them together builds a collaborative process for an iterative model of change. Adopting improv tools is one way to help create a team-based mindset and empower teams to change the system in a profound and meaningful way. Claire S. Neely, MD, FAAP, is chief medical officer at the Institute for Clinical Systems Improvement (ICSI).

Sarah Horst, MA, is a project manager/health care consultant at ICSI.

Join the Best. Join Entira Family Clinics. Entira Family Clinics is an award-winning, physician owned and operated group of primary care, after hours care, and express care clinics serving the East Metro for over 50 years. If you want the opportunity to influence how your practice is run, then look no further. Where Generations Thrive®: Our community-based clinics offer high-quality care specializing in family medicine and serve families at all stages of life.

Join our team today!

For more information, contact: Len Kaiser: 651-772-1572 or lkaiser@entirafamilyclinics.com

| entirafamilyclinics.com | 38

MAY 2019 MINNESOTA PHYSICIAN

STAY FOCUSED AMONG THE DISTRACTIONS.

Minimize the things that get in the way of why you’re in healthcare to begin with. A focus on reducing lawsuits is just one way we do this. For more information or your nearest agent, contact us at 800.225.6168 or through coverys.com. M E D I C A L P R O F E S S I O N A L L I A B I L I T Y I N S U R A N C E  A N A LY T I C S  R I S K M A N A G E M E N T  E D U C A T I O N

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is for joint repair. University of Minnesota Health is leading the way in cartilage restoration. As the first comprehensive joint restoration program in the Twin Cities, our surgeons use the latest techniques and treatments to ensure that each patientâ&#x20AC;&#x2122;s unique joint pain needs are met, regardless of whether they are candidates for cartilage restoration procedures. From autologous chondrocyte implantation to meniscus transplantation, osteochondral allograft transplantation, multi-ligament knee reconstruction and biologic injection therapies, weâ&#x20AC;&#x2122;re here to get your patients back to enjoying an active lifestyle. Refer your patients by calling: 763-898-1004 (Maple Grove) 612-672-7000 (Minneapolis)

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University of Minnesota Health is a collaboration between University of Minnesota Physicians and University of Minnesota Medical Center. ÂŠ2019 University of Minnesota Physicians and University of Minnesota Medical Center