THE INDEPENDENT MEDICAL BUSINESS JOURNAL
Volume XXXI, No. 4
Minnesota Prescription Monitoring Program
The CARES Model
Important updates responding to an epidemic BY BARBARA A. CARTER
I The CARES Model A way to engage your patients BY ARCHELLE GEORGIOU, MD
ixty-two percent of Americans say they want to deliberate with their physician about their treatment options. And, to help make the right choices, consumers have been armed with an array of health information sites, symptom checkers, cost calculators, and provider quality scores and report cards. Unfortunately, the majority of patients simply abdicate decision-making to their doctor. Only 15 percent of consumers actively use health care apps and only 20 percent of patients raise the topic of treatment alternatives with their doctor. The CARES Model to page 104
n a recent survey conducted by the American Medical Association, in which 44 of the 49 state prescription drug monitoring programs (PDMP/PMP) responded there was a 180 percent increase, between 2014 and 2016, in the number of physicians’ and other health care professionals that had registered for an account with a PDMP/ PMP. During that same time there was also a 121 percent increase in the number of times physicians and other health care professionals used a state’s PDMP/PMP. In 2016 alone, there were more than 136.1 million queries of those 44 state’s databases. Minnesota Prescription Monitoring Program to page 124
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Volume XXXI, Number 4
COVER FEATURES The CARES Model A way to engage your patients
Minnesota Prescription Monitoring Program Important updates responding to an epidemic
By Archelle Georgiou, MD
By Barbara A. Carter
By Nicole Villapiano, MD, MSc, and Tyler N.A. Winkelman, MD, MSc
HEALTH CARE POLICY
Neonatal abstinence syndrome The rising use of opioids during pregnancy
Janet M. Odeshoo, FEMA
The 2017 legislative wrap-up The battle over the budget
By Nate Mussell, JD
Air medical transport Providing seamless critical care
By R.J. Frascone, MD, and Kolby Kolbet, RN, MSN, CFRN, CMTE
TRANSPLANT SURGERY 32
Beating heart in a box Expanding the transplant donor pool
By Kenneth Liao, MD, PhD
MINNESOTA HEALTH CARE ROUNDTABLE Precision Medicine A new approach to care
PROFESSIONAL UPDATE: ORTHOPEDICS Direct anterior hip replacement A minimally invasive procedure
By Daren Wickum, MD
Mike Starnes, email@example.com
EDITOR________________________________________________ Lisa McGowan, firstname.lastname@example.org ASSOCIATE EDITOR_____________________________ Richard Ericson, email@example.com ART DIRECTOR_______________________________________Sunshine Sevigny, firstname.lastname@example.org OFFICE ADMINISTRATOR______________ Amanda Marlow, email@example.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; email firstname.lastname@example.org; 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.
MINNESOTA PHYSICIAN JULY 2017
Unnecessary Medical Services Cost Millions Minnesota spent $54.9 million on low-value medical tests in 2014, despite the fact that they’re known to provide little benefit and in some cases have the potential to cause harm, according to the Minnesota Department of Health (MDH). Patients spent $9.3 million out-of-pocket for these services. There are more than 450 services that have been identified nationally as low-value. MDH and researchers at Mayo Clinic identified a subset of only 18 of these low-value services that primarily fall into diagnostic imaging and disease screening to study in Minnesota. These included unwarranted imaging for people with low back pain or for uncomplicated headache; cervical cancer screening for women younger than 21 or older than 65; colorectal cancer screening for adults ages 85 and older; and prostate-specific antigen tests for prostate cancer in men ages 75 and older. The
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18 services analyzed were delivered relatively infrequently, but accounted for a substantial investment of health care resources in 2014. Researchers used data from the Minnesota All Payer Claims Database to analyze health care claims for Minnesota patients. They found that in 2014, there were about 92,000 encounters associated with low-value diagnostic imaging and 69,000 encounters with low-value disease screening, and 15,000 encounters with low-value preoperative testing. The most common and most costly one was diagnostic imaging for uncomplicated headaches, which accounted for 40 percent of overall low-value cost. “Reducing low-value services requires a culture of change for patients and providers to recognize that ‘more’ isn’t always ‘better,’ when it comes to imaging and screening,” notes Rozalina McCoy, MD, endocrinologist, primary care physician, and health services researcher at Mayo Clinic, who assisted with identifying service types
and interpreting the results of the analysis. “In fact, many of these tests and procedures are not just ‘low-value’ and therefore a poor use of health care resources, but they can cause real harm to patients that receive them.”
Rochester Epidemiology Project Allows Public Access to Information The Rochester Epidemiology Project is launching a new tool that will offer regional disease prevalence data to health care providers, researchers, and patients. The tool, called the Data Exploration Portal, uses information from the database that includes nearly all health information for Olmsted County residents for more than 50 years and medical records from a large number of residents in 26 surrounding counties in Minnesota and Wisconsin. “The Rochester Epidemiology Project Data Exploration Portal provides a new way to examine the occurrence of diseases and facilitate
prevention in our community,” said Walter Rocca, MD, neurologist and epidemiologist at Mayo Clinic and co-director of the Rochester Epidemiology Project. The information available in the tool can be used by researchers to compare rates of different conditions, find age- or sex-specific information, identify geographic clusters, and determine if data are available to support their hypothesis. “The new data exploration portal will provide information about whether a particular condition exists in a geographic area,” said Kathryn Lombardo, MD, president of Olmsted Medical Center. “For clinicians, this means we will be able to better determine the likelihood that two different clinical conditions could occur together. And, at point-of-care, it will help us determine what questions may need to be asked of our patients and, ultimately, enable us to provide more personalized care.” In addition, public health agencies can use it to narrow their focus
to the conditions most relevant to their specific communities, and primary care providers can use it to identify potential patient needs and personalize care. “Knowing what conditions are most common in our communities helps us plan programs and allocate funds in an efficient manner,” said Pete Giesen, director of Olmsted County Public Health Services.
Essentia Health Launches Emergency Dental Care Program Essentia Health–St. Joseph’s Medical Center in Brainerd is changing how it deals with patients who have emergency dental problems. Instead of only offering antibiotics and pain medication, the hospital now offers patients referrals to local dentists to treat the underlying problem. The hospital is partnering with seven local dental offices and the United Way of Crow Wing and Southern Cass counties through a project called Help Crow Wing County Smile, a collaboration aimed at helping patients who lack the ability to pay for dental care or those who rely on state or federal medical insurance to get connected to dental care. Patients are referred to a participating dentist and make their own appointments. “Many people on Medical Assistance can’t get dental care so we become their only resources,” said Terry Wurtzberger, director of St. Joseph’s emergency department. Wurtzberger estimates that between 25 and 35 patients visit the department each month because of dental emergencies and an additional 10 to 20 patients go to the urgent care location in the Baxter Clinic. “The emergency department is not equipped to deal with dental problems,” said Kevin Dens, DDS, a dentist in Baxter who serves as president of the board of the Minnesota Dental Association. “They can’t address the underlying problem. By the time people have pain, the decay is so deep into the teeth that it is a major problem.” According to Dens, low reimbursement rates have prompted some
dentists to stop accepting patients on government programs, which reduces access to dental care and contributes to the number of people seeking emergency dental care at hospitals. Patients who are referred to a dentist through the program are asked to give back to the community with an hour of volunteer time in exchange for each $25 worth of dental care they receive. The United Way coordinates that part of the program through an online hub.
Stratis Health and MAPS Unite to Advance Safe Care The boards of directors for Stratis Health and the Minnesota Alliance for Patient Safety (MAPS) have ratified MAPS as a subsidiary of Stratis Health, effective Aug. 1. Stratis Health was one of MAPS’ five founding partners when it was incorporated in 2013 and has served in a leadership capacity for the statewide patient safety coalition since its inception in 2000. “This new partnership builds on our commitment to MAPS and patient safety,” said Jennifer Lundblad, PhD, MBA, president and CEO of Stratis Health. “We look forward to addressing safety more deeply and broadly through daily interaction with like-minded patient safety practitioners who advance the patient safety practice field.” Together, the organizations will work to strengthen patient safety efforts across the care continuum with special emphasis on elevating the voice of the patients. Their goals are to make care safer by reducing harm caused in the delivery of care and ensure that each person and family is engaged as partners in their care— two of the National Quality Strategy’s top priorities as outlined by the Department of Health and Human Services, Centers for Medicare & Medicaid Services. “Joining with Stratis Health expands MAPS’ ability to continue to grow across the continuum of care and have the capacity to respond to new safety and patient engagement MINNESOTA PHYSICIAN JULY 2017
opportunities,” said Gayle Kvenvold, president and CEO of LeadingAge Minnesota and chair of the MAPS board of directors. “MAPS members should see the value of membership increase, as we tap into Stratis Health’s nonprofit management expertise and increase operational efficiency.” MAPS has nearly 100 member organizations, including health care associations and organizations, consumers, employers, health plans, and state agencies and boards.
Summit and HealthEast Partner on Orthopedic Care The boards of directors for Summit Orthopedics and Fairview Health Services’ HealthEast Care System have approved an agreement through which Summit Orthopedics will become HealthEast’s exclusive orthopedic care partner. The agreement also makes HealthEast a minority owner of Summit Orthopedics’ Vadnais Heights Surgery Center. Summit Orthopedics physicians will treat orthopedic patients at
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HealthEast’s inpatient hospitals and work with them to improve the patient experience and quality of care. The privately owned company employs 50 orthopedic specialists at 33 locations. “We’ve always had a deep respect for the compassionate and quality patient care that HealthEast offers,” said Adam Berry, CEO of Summit Orthopedics. “This agreement presents Summit with a wonderful opportunity to work in tandem with HealthEast to bring to market a healthcare model that doesn’t currently exist in the Twin Cities and to have a tremendous and positive impact on patient care.”
Local Centers Join Study on Financial Impact of Cancer Care More than 20 Minnesota and western Wisconsin cancer centers are participating in a National Cancer Institute study to determine how often cancer patients face financial problems and how it affects their
quality of life. Researchers will focus specifically on colorectal cancer patients because of the new, expensive drugs being used to treat it and because many people are surviving the disease, meaning they then face the financial impact of medical bills. “It’s clear the cost of cancer care drugs is rising rapidly,” said Daniel Anderson, MD, a principal investigator for the Metro-Minnesota Community Oncology Research Consortium, investigator at HealthPartners Institute, and oncologist with HealthPartners. “This study will help us figure out how drug cost is affecting patients’ ability to receive care and afford other expenses.” There are 427 participating cancer care centers across the U.S. that will recruit at least 370 patients who have colorectal cancers that are metastatic. Local sites include HealthPartners’ Metro-Minnesota Community Oncology Research Consortium; Regions Hospital Cancer Care Center; Park Nicollet Frauenshuh Cancer Center, HealthPartners Riverside Cancer Care Center; Lakeview
Hospital Cancer Care Center; Westfields Hospital Cancer Care of Western Wisconsin; Abbott Northwestern Hospital; and Hennepin County Medical Center. The research team is recruiting 350 patients who have colorectal cancer at 174 institutions across the U.S. The study will take place over the course of one year. Every three months, patients will fill out questionnaires that ask specific questions about how cancer care has affected their personal finances. “We know there is a financial impact,” said Pam Pawloski, site principal investigator for the study and investigator at HealthPartners Institute. “By conducting this study, we will systematically evaluate it and understand its impact on a large group of patients. The ultimate goal of this study is to estimate the incidence of cancer treatment-related financial hardship. By understanding this better, we can develop interventions to address the financial consequences patients face during cancer treatment.”
Richard Ehman, MD, radiologist at Mayo Clinic, has been recognized as one of 175 National Academy of Inventors fellows for 2016. It is the highest professional distinction awarded only to academic inventors who have made tangible impacts on quality of life, economic development, and the welfare of society. Ehman is best known for his work in medical imaging. He was a pioneer in the development of magnetic resonance imaging (MRI) technology and his inventions have revolutionized the MRI field since the 1980s. He also helped develop magnetic resonance elastography (MRE) in recent years. He holds more than 40 patents and many of his inventions are widely used. Ehman has a joint appointment in the department of physiology and biomedical engineering and is the Blanche R. and Richard J. Erlanger Professor of Medical Research. He earned his medical degree at the University of Saskatchewan. Michelle Biros, MD, MS, a professor of emergency medicine, interim department head, and vice chair of research in the department of emergency medicine at the University of Minnesota, has received the Advancement of Women in Academic Emergency Medicine award from the Society for Academic Emergency Medicine for her significant contributions to the field. She has been a leader in emergency medicine and research as well as a mentor to women in medicine throughout her career. She serves as the principal investigator for the University of Minnesota hub of the National Institute of Neurological Disorders and Stroke (NINDS)-funded Neurological Emergencies Treatment Trials network and the co-principal investigator of the regional coordinating center for the NINDS-funded Stroke Net. She earned her medical degree at the University of Minnesota Medical School. Kevin Engel, MD, PhD, chief of ophthalmology at Hennepin County Medical Center, has been named president of the Minnesota Academy of Ophthalmology. He earned his medical degree at the University of Minnesota Medical School and served as a board member of the academy for several years. In addition, the academy awarded the 2017 George T. Tani, MD, Humanitarian Award to James Garrity, MD, oculoplastics and neuro-ophthalmology practitioner at Mayo Clinic, for his work involving charitable activities, indigent care, and community service. Garrityâ€™s contributions include founding and directing a monthly eye care clinic for people without insurance at the Rochester Salvation Army. He earned his medical degree at the University of Minnesota Medical School. George Rounds, MD, a retired physician from Bigfork Valley, received the Rural Health Lifetime Achievement Award at the Minnesota Rural Health Conference in Duluth in recognition of his 37 years of work as a family physician and his commitment to providing access to quality health care. Roundsâ€™ leadership includes recruiting physicians to the area and serving as chief of staff at Bigfork Valley Hospital. He also served as associate professor at the University of Minnesota and as a preceptor at the Duluth Family Practice Residency Program. He earned his medical degree at the University of Minnesota Medical School. MINNESOTA PHYSICIAN JULY 2017
Disaster preparedness Janet M. Odeshoo, Acting Regional Administrator of the Department of Homeland Security’s Federal Emergency Management Agency (FEMA) Region V in Chicago, Illinois What are some of the disasters that can impact Minnesota and how can readers learn about their disaster risks?
The state of Minnesota has historically been threatened by a range of natural disasters, including severe weather such as flooding, tornadoes, extreme heat, and blizzards. Hazardous material incidents, cyber security threats, power outages, terrorism, pandemics, and home and forest fires are additional risks. It doesn’t matter where you live, most communities may be impacted by several of these hazards during a lifetime. FEMA encourages individuals to become informed about the risks unique to their location: identify the hazards in your area and plan the necessary safety actions for each. Local emergency management offices can help identify the hazards in an area and outline the local response plans and recommendations for individuals to prepare for each. FEMA’s ready.gov website (www.ready.gov/be-informed) also helps you learn about potential emergencies and how to prepare for and respond to them. How does FEMA declare a disaster?
Disasters always start and end locally. A majority of events that occur across the country are not of the magnitude that warrant federal government involvement—in most cases local and state first responders are fully capable of handling the response and recovery efforts. However, in some cases, a disaster is beyond the capabilities of the state and local government to respond and federal assistance may be necessary. The first step is for the governor of the impacted state to request that FEMA conduct preliminary damage assessments to estimate the extent of the disaster and its impact on individuals and public facilities. This information can then be used by the governor to demonstrate whether the disaster is of such severity and magnitude that effective response is beyond the state’s capability to respond to and recover from. Based on the governor’s request of the President, the President may declare that a major disaster or emergency exists, activating a range of Federal programs to assist in the response and recovery effort. What steps can everyone take to be better prepared for disasters?
FEMA encourages all individuals to answer the following questions: How might a disaster affect
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me? What are my personal needs during a disaster? By evaluating individual risk and needs and then making an emergency plan that addresses those risks and needs, everyone can be better prepared.
have access to your cell phone contacts. • Understand how to receive emergency alerts and warnings. Make sure all household members are able to get alerts about an emergency from local officials. Check with your local emergency management agency to see what alerting system may be available in your area, and learn more about alerts by visiting: www.ready.gov/alerts. Are there additional disaster preparedness steps physicians should consider recommending to patients with medical, access, and functional needs?
It is important for everyone to know what their unique needs would be in the event of an emergency. There are measures—in addition to those discussed earlier—for physicians to recommend to their patients so they are better prepared for emergencies before they happen:
To offer medical expertise after a disaster, consider looking into the Medical Reserve Corps.
• Make hard copies and maintain electronic versions, including a portable thumb drive, containing: medical prescriptions; doctors’ orders for durable medical equipment, (including style and serial number), consumable medical supplies, and assistive devices they use; medical insurance cards, Medicare or Medicaid card; a list of patient allergies, and health history.
A few general preparedness steps to consider taking include: • Build and maintain an emergency supply kit. Include drinking water, a first-aid kit, canned food, a radio, flashlight, and blankets. The FEMA website has a disaster supply kit checklist, as well as safety tips and information. Don’t forget to store additional supply kits in your car and at the office. • Have a family emergency plan in place, and don’t forget to include your pets. Your family may not be together when a disaster strikes so it is important to plan in advance: how will you get to a safe place; how will you contact one another; how will you get back together; and what will you do in different types of disasters? • Make a contact card small enough to put in a wallet with important names and numbers to use in case of an emergency and if you don’t
• Maintain a list of phone numbers for other doctors, pharmacy, service providers, and medical facilities. • If they own a medical alert tag or bracelet, wear it. • If possible, stock extra over-the-counter and other medical supplies. • If patients work with a medical provider or organization to receive life sustaining medical treatment such as dialysis, oxygen, or cancer treatment, patients should work in advance of an emergency to identify alternative locations where they could continue to receive treatment if they are unable to go to their regular medical provider. • If patients receive in-home assistance or personal assistance services, like meals on wheels, work with their provider agency in advance of an emergency and develop a backup plan for continued care.
Physicians can recommend that individuals visit FEMAâ€™s web site at www.ready.gov/individuals-accessfunctional-needs to learn even more about preparing for a disaster with access, functional, or medical needs. Is it possible that well-intended physicians volunteering at the spur of the moment in a disaster can cause more harm than good?
Immediately following a disaster, a community can become easily overwhelmed by the amount of generous people who want to help. Contacting and joining an established organization will help ensure that the capabilities of a volunteer physician are used in the most beneficial way possible. There are many organizations and faith-based groups in most communities that have active disaster programs and need volunteers. To offer medical expertise after a disaster, consider looking into the Medical Reserve Corps (MRC). MRC is a national network of volunteers, organized locally to improve the health and safety of their communities. Their mission involves responding to disasters and building community resilience. Visit https://mrc.hhs.gov/ HomePage for more information on the MRC. For more information about other types of post-disaster volunteer opportunities, visit https://www.nvoad.org/. Depending on the type of disaster, the need to have your medical clinic open may be critical. What can physicians groups do
to be sure their clinics are prepared for a disaster?
Investing in a preparedness program is important for any business to ensure they can remain functional and serve their community after a disaster. Planning is key. In developing an all hazards preparedness plan, potential hazards should be identified, vulnerabilities assessed, and potential impacts analyzed. Implementation of the preparedness program includes identifying and assessing resources, writing an all-hazards preparedness plan, developing a system to manage incidents, and training employees so they can execute those plans. Clinics should conduct tests and exercises to evaluate the effectiveness of their preparedness program and make sure employees know what to do. There is a wealth of resources to help develop a preparedness program at www. ready.gov/business. This website provides tools and templates to make it easier to ensure that businesses can continue operating, even after a disaster. Many people may not be aware of the number of disasters that occur each year in the U.S. or the role that FEMA plays. Can you share some success stories?
FEMA responds to numerous disasters across the country. In Minnesota alone, since 1979, our agency has supported more than 50 major disaster
declarations across the state. This year is significant as it marks the 20-year anniversary of the 1997 Red River Floods in Minnesota. The Red River rose to 26 feet above flood stage and forced the evacuation of 53,000 people, causing $5 billion in damages across the state. Such a large recovery was hard fought and long-term, requiring the coordination of many in order to be successful. Local, state, and federal agencies, along with voluntary agencies, community organizations, local businesses, and residents were all a critical part of the rebuilding process. Not only did the impacted communities build back, but they built back smarter and stronger. Readers can learn more about this disaster and the successful recovery by visiting our website, www. fema.gov/20th-anniversary-1997-red-river-flood. Janet M. Odeshoo is Acting Regional Administrator for FEMA Region V and is responsible for coordinating FEMA preparedness, mitigation, and disaster response and recovery activities in Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin. She has been with FEMA since 1981 and has extensive experience in all of FEMAâ€™s programs. She is responsible for many improvements made in damage assessment, estimating, response, recovery, and mitigation strategies, policies, and procedures.
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3The CARES Model from cover While patients willingly delegate decisions to their doctor, they may simultaneously, and quietly, feel unsettled about the treatment plan selected for them. This “decisional conflict” results in patients being more likely to change their mind and delay their decisions. Retrospectively, these patients are more likely to feel regret—even if they have a good health outcome— when they realize they could have looked at more information and weighed the pros and cons carefully. And, they are more likely to blame their practitioner if they have a bad outcome.
A physician’s values and preferences are well informed but not a substitute for the patient’s because doctors’ and patients’ values are not always aligned. Only an individual can decide what tradeoffs they are willing to make relative to risks, complications, disability, pain, disfigurement, inconvenience, or financial investment.
The CARES Model
My recently published book, “Healthcare Choices: 5 Steps to Getting the Medical Care You Want and Need,” offers consumers a roadmap, the CARES Model, for making health care decisions. The model does not presume or imply that a patient has medical expertise or that their role is to replace the clinician. It emphasizes that doctors are experts in evaluating symptoms, establishing Resist the temptation the path to a diagnosis, and using evidence-based to answer the question information to lay out treatment options. Patients, “Doctor, what would you do?” however, are experts in themselves and responsible for understanding, identifying, and sharing their unique needs, beliefs, and preferences. Together, patients and doctors are equal partners in achieving health care outcomes.
A cardinal symptom of decisional conflict is when a patient asks, “Doctor, what would you do?” When people feel most vulnerable, they look for guidance and reassurance and hope their doctor will make the right decision for them. Empathically, most physicians answer this question; unfortunately, this merely deepens the patient’s conflict especially when the decision is between equally effective treatments. A physician who shares the health care choice they would make for themselves oversteps the boundaries of professional expertise and enters the zone of imposing personal bias into the recommendation.
This CARES Model will empower some patients to get actively engaged in their care, and physicians generally make the time to address questions especially if an individual is diagnosed with a serious medical condition. But here’s the problem: most patients don’t feel confident initiating or fully engaging in a conversation with their physician because they perceive a power imbalance. I routinely ask people why they are reluctant to “lean in” regarding their medical care, and the most frequent response is “No way! He (or she) might get angry.” This (hopefully subjective) fear of retaliation is pervasive and present across educational levels and financial strata. Patients’ passivity is not their fault—nor their doctors’. It is rooted in American culture. According to the World Values Survey, the U.S. is grounded by traditional values that include national pride, high religiosity, strong parent-child ties, and deference to authority. In other words, as a nation, we are obedient rule followers who wait for direction from our politicians, pastors, parents—and physicians. When consumers are faced with hypothetical scenarios, they agree that people should advocate for themselves and the hierarchical dynamic with physicians is unhealthy. Nevertheless, culture and norms trump rational behavior, and people become patients, they want permission to be actively engaged in their care. So give your patients what they want—permission. Let them know it is really okay—and that you expect them—to participate in their health care decisions. Here are the five steps of the CARES Model along with complementary actions physicians can take to support and encourage patients to get engaged: 1) Condition; 2) Alternatives; 3) Respect; 4) Evaluate; 5) Start. Understand your “condition” While it may seem obvious that patients should understand their medical situation, they often overestimate what they really know. For example, in a study of patients needing a bone marrow transplant, 77 percent thought they had enough information, but when asked specific questions, only about 52 percent demonstrated knowledge of the facts. I recommend that patients ask “So what?”—five times—to truly understand the implications of their condition.
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4 Physician’s role: Use lay language to proactively explain the “so what” of a patient’s condition. When I recently told a friend that she might have a septic knee and needed to go to the ER she ignored my recommendation until I explained the “so what”—that a joint infection could destroy the cartilage. She left my home and went straight to urgent care. Know your “alternatives” People expect their doctors to objectively offer all the options for their care. However, physicians have biases that can lead them to recommend one treatment over another even if alternative treatments offer the same or even better outcomes. I recommend patients ask “What else?”
4 Physician’s role: Recognize your unintended
a time,” this mindset reinforces a passive relationship with the physician and fuels a lack of accountability to the care plan. Instead, I recommend patients ask, “What next?” and establish a clear calendar of next steps.
4 Physician’s role: Explain (exactly) what patients need to do over the next 30, 60, and 90 days. Prepare them for known complications that can be safely addressed at home and when these complications are serious enough to require medical attention. Discourage them from “toughing it out” or waiting for their next visit if their symptoms surpass established thresholds.
The majority of patients simply abdicate decision-making to their doctor.
human bias to recommend treatment you are most familiar with and suggest that patients consider other evidence-based treatment alternatives. Encourage them to use credible websites such as MayoClinic.org or print the Patient Education (Beyond the Basics) sections from UpToDate. “Respect” your preferences Patients’ preferences typically fit into four major categories: 1) medical (chance of a cure or recovery versus the risk of complications or death); 2) quality of life (level and duration of pain, dependence, or inconvenience); 3) financial (costs incurred by out-of-pocket expenses as well as time away from work); and 4) personal (cultural and religious beliefs, fears, and other sociocultural factors). I recommend that patients ask themselves, “What matters most?”
Patients look for guidance from their physicians. Empower them, enable them, and encourage them to be actively engaged in their health. The outcome is better care because they will receive the care they need…and want.
Archelle Georgiou, MD, is an executive in residence at the University of Minnesota Carlson School of Management and has a regular health segment on KSTP-TV in Minneapolis. In February 2017, she released her first book, “Health Care Choices: 5 Steps to Getting the Medical Care You Want and Need.” She is trained in internal medicine.
4 Physician’s role: Resist the temptation to answer the question “Doctor, what would you do?” Instead, acknowledge the non-clinical aspects of a health care decision. Encourage patients to create a list of pros and cons in the four categories listed earlier and offer to review them at a follow-up visit. “Evaluate” your options Patients should take time to deliberate the tradeoffs of each option and avoid the pressure of making a decision while sitting in a doctor’s office. Neurobiologic research shows that when people get advice from an expert, the decision-making parts of the brain temporarily shut down causing patients to ignore their own internal value mechanisms and offload the decision-making. The risk: decisional regret. I recommend that patients ask themselves “What decision gives me peace?”
4 Physician’s role: Don’t ask patients to make decisions when they are in the room with you. At a minimum, step out and see another patient to give them time to contemplate on their own. For elective surgery or major decisions, recommend that they take time to review their options. “Start” taking action Patients not only share the responsibility for decision-making but also adhering to medications, appointments, tests, procedures, monitoring, and lifestyle changes. While a common coping mechanism is to “Take one day at
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3Minnesota Prescription Monitoring Program from cover Mandated registration Although the numbers continue to increase, a bill passed during the 2016 Minnesota legislative session requires all Minnesota licensed prescribers, who practice in this state, and who hold a valid DEA prescriber registration to prescribe to humans, to register for and maintain an account with the Minnesota Prescription Monitoring Program (MN PMP). Such prescribers must register and activate their account no later than July 1, 2017.
PMP account will bring to the prescriber’s attention the availability of this critical information to assist in saving lives. PMPs have been identified as a critical tool in assisting prescribers and dispensers in identifying patients who may be at risk for overdose, addiction, or who may be visiting multiple providers and multiple dispensers seeking controlled substances for nonmedical purposes.
Prescribers who are authorized to prescribe controlled substances may apply for access to the database by completing an online access request form during their annual professional license renewal, or at one of the many educational events the Minnesota is one of 49 states PMP staff attend throughout the state. Information Minnesota is one of 49 states that currently that currently have collected during the registration process includes have an operational PMP. The Minnesota PMP, an operational PMP. name, practice name and address, professional which is administered by the Minnesota Board of license number, DEA registration number, and email Pharmacy, has been operational since January 2010 address. Once the information has been submitted and continues to collect an average of 8 million electronically, the credentials provided will be verified controlled substance (Schedules II-V), gabapentin and notifications regarding the status of the account and butalbital prescription records annually. In request followed by a temporary password will be 2016 alone, more than 1.2 million queries of patient sent via email, normally within 15 minutes of application. The account profiles were requested by more than 16,000 prescribers who had been holder must immediately access their account and establish a unique, secure granted direct access to the PMP database. password. Failure to reset the temporary password will reflect the account’s A critical tool for battling addiction status as inactive or “not maintained.” While more than 30 states have mandated the use of the PMP under certain circumstances and with the hopes of increasing use of the database, the MN PMP is hoping that the requirement to register for and maintain a Maintaining your PMP account The MN PMP staff is currently developing a new mechanism to notify account holders when their passwords will expire. Account passwords are set to expire after 180 days and when the new process is implemented, an email will be generated by the system 10 days prior to the password expiration, and again three days prior if no action was taken. If the password does expire, the account will be locked. The account holder can conveniently use a self-service button to retrieve a new password by answering a security question. Additionally, another new mechanism to notify account holders when it is time for their annual account profile update is in development. Similar to the notifications received for password expirations, the result in failure to take action will be deactivation of the account. Account deactivation will require a phone call to the help desk for credential verification and reactivation. Monthly, the MN PMP staff will provide a list of all active accounts to the Minnesota Board of Medical Practice, in addition to the other Boards that license permissible users of the MN PMP data. The MN PMP has no jurisdiction over these health care professionals; therefore, it is entirely up to the Boards to decide what actions will be taken when one of their licensees does not hold an active MN PMP account. For information regarding the requirement to register for a MN PMP account, please contact the appropriate health licensing board. The Minnesota Board of Pharmacy has worked with the boards that license prescribers to integrate registration into online renewal processes. However, prescribers can also register on the MN PMP website. Access Request Forms can be found at www.pmp.pharmacy.state.mn.us on the “PMP User Registration and Resources” page. Registration and access are free!
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In addition to registration during annual license renewal and directly on the MN PMP website, the MN Board of Pharmacy, through a Harold Rogers Prescription Drug Monitoring Program grant is providing funds to the Minnesota Board of Medical Practice to incorporate the ability to apply for a MN PMP account directly from their Board’s website. This new functionality is in development as of this writing and is scheduled to be deployed before the end of 2017. This will make it more convenient for newly licensed physicians to register for an account.
document compliance with a therapeutic regimen. However, the Minnesota Board of Pharmacy can’t guarantee that any patient profile is accurate or complete. Dispensers have an obligation to accurately report all controlled substance prescriptions that they have dispensed to the MN PMP database. However, they do not always do so—despite the efforts of the MN PMP staff to monitor the reporting of prescriptions and to work with dispensers to correct inaccurate or incomplete data. For more information or to inquire about the registration process for the MN PMP, please contact the MN PMP office via email at minnesota.pmp@state. mn.us or at 651-201-2836.
Use of the MN PMP RxSentry
[Minnesota] prescribers Prescribers may access the MN PMP database 24 must register and activate hours a day, seven days a week. Prescribers themselves their [PMP] account or their employers may decide how often and when no later than July 1, 2017. they will request patient profiles. Some may decide Barbara A. Carter manages the MN PMP, along to do so for all patients for whom the prescribing of with Katrina Howard, PharmD and Shannon Whitman, a controlled substance is being considered. Others program administrator, and continues to advance the may do so only when they suspect potential abuse, program by ensuring the incoming data is timely, misuse, or diversion. The reports can be used to complete, and accurate and that permissible users of determine appropriate medical treatment such as referral to a pain-management specialist as well as to identify “doctorthe data have continuous access. Barbara currently serves as vice president of shopping” behaviors. The MN PMP encourages prescribers to assist the National Association of State Controlled Substances Authorities (NASCSA) individuals tentatively identified as having an issue of concern regarding and co-chairs its PMP Committee. Additionally, she serves on the National controlled substances in finding the help they need. Recent improvements Alliance for Model State Drug Laws (NAMSDL) PMP Resource Group and to the MN PMP website include a resource section for prescribers with links the National Association of Boards of Pharmacy (NABP) PMP InterConnect to prescribing and screening tools as well as treatment resource information. In addition to checking on a patient’s controlled substance prescription history in the state of Minnesota, an authorized practitioner with an active MN PMP user account has the ability to view their patient’s history in other states. Through the “Multiple State Query” function, a prescriber, after selecting from a list of states currently participating in the interstate data exchange, can locate additional patient information. Minnesota is now actively participating with 31 states with additional states coming on board in the near future.
A prescriber with an active MN PMP account may also use the system to access a report of the controlled substance prescriptions dispensed using their DEA registration number. This functionality enables prescribers to monitor use of their DEA registration number and potentially detect fraudulent use. Prescribers must respect confidentiality, and may only access data on those patients for whom they are directly providing care, in accordance with Minnesota Statutes Section 152.126. Patient profile reports from the Minnesota PMP database are designated as private data and can be used to supplement an evaluation of a patient, confirm a patient’s drug history, or
How to Apply: Access Request Forms can be found on the MN PMP website at
www.pmp.pharmacy.state.mn.us on the “PMP User Registration and Resources” page.
MINNESOTA PHYSICIAN JULY 2017
Air medical transport Providing seamless critical care BY R.J. FRASCONE, MD, AND KOLBY KOLBET, RN, MSN, CFRN, CMTE
n today’s world of outcomes-based medicine, the goal in transporting a patient by air is not only to minimize the out-of-hospital transport time, but to bring the expertise and technology from the tertiary care center to the patient to ensure continuum of care. While vehicles and sophisticated medical equipment are critical components to patient transport by ground and air, the old mantra of moving patients from point A to point B focusing on speed has substantially evolved. In the past, the goal was simply focused on minimizing the out-of-hospital transport time. Consider the following scenario: A 62-year-old male patient presents to a rural Minnesota emergency department with shortness of breath and fever. Upon examination, it is determined that the patient likely is septic and in need of aggressive antibiotic therapy, vasopressor support, and pulmonary management. The level of care and support this patient requires is over 100 miles away at the tertiary care center. Given the care needed and distance involved in reaching definitive care, a variety of considerations need to be taken into account: • What is the best mode of transport for this patient?
• Who will care for and address the patient’s needs en route? • Are the personnel onboard prepared to manage the patient in a space-limited setting with minimal resources? • Is the patient’s airway secured? If not, do the transport personnel have the skill to secure the airway no matter how difficult? • Can the patient be provided with lung-protective, sophisticated mechanical ventilation during transport? • Can non-invasive monitoring equipment, point-of-care lab testing, and point-of-care ultrasound be used to guide aggressive fluid resuscitation and intravenous vasopressor support? Is this level of care possible onboard a helicopter today? The answer is, yes. Consider this accident scenario: A 22-year-old male rolled his ATV at a high rate of speed. Initially, he complained of chest and abdominal pain. His level of consciousness was declining. Rapid sequence intubation was completed without complication and he was transported by helicopter to a trauma center. Although his chest appeared to be rising, it was night and light was limited. Ambient noise limited a complete physical exam. Within two minutes of using the bedside ultrasound, Life Link III clinicians noted that the patient did not have sliding lung sign on the right so a needle chest decompression was completed. The patient’s oxygenation (SpO2) and end-tidal carbon dioxide (EtCO2) improved. The ultrasound was then used to access the patient’s abdomen and he had free fluid in Morison’s pouch. Based on this information, the Life Link III team opted to hang a unit of blood, which turned out to be lifesaving for the patient. The findings were communicated to the trauma center and confirmed with an ultrasound exam on arrival and the patient was expedited to the surgical suite. He was discharged from the hospital two weeks later, minus one spleen and a small hole in his chest that was healing. Over the years, the EMS helicopter industry has transitioned from having to guess how to treat a patient in-flight, to using a targeted data-driven approach. Flight nurses and paramedics use sophisticated diagnostics— previously available only in hospitals—to guide care pathways. The use of data translates to better care management and improved outcomes for patients.
A great Midwest care collaboration model To understand how we have evolved to such a sophisticated care delivery capability in the air medical setting, it’s important take a look back. The formation of Life Link III is a unique Minnesota story of collaboration across competing health care providers to advance access to critical care throughout our state. The company was created over 30 years ago as one of the first non-profit consortiums in the country to transport critically ill patients by helicopter. Since its inception, Life Link III has focused on clinical excellence and is an early adopter in bringing innovative new technology to patient care. In 1974, the company (then known as Bio Medical Research Associates, or BMRA), was a pioneer in the industry by providing intra-aortic balloon pump support, Swan-Ganz, and other hemodynamic monitoring services to hospitals by ground transport. In 1985, BMRA was purchased due to a collaborative project initiated by the University of Minnesota (Fairview Health Services), Abbott Northwestern Hospital (Allina Health), and St.
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Paul–Ramsey Medical Center (Regions Hospital/HealthPartners), and the non-profit consortium known as Life Link III was born. Over three decades of experience in working together has transformed this unique collaboration into a consortium of members that now comprises nine leading health care organizations with hospital facilities located in Minnesota, Wisconsin, and North Dakota. The opportunity to leverage the knowledge and expertise of 45 member-owner hospital partners has helped shape the innovative approaches used in today’s air medical setting and provides critical access to care for patients throughout our state and region. While onboard medical equipment continues to advance, so does the air medical dispatch process. Life Link III operates a state-of-the-art Communication Center staffed with certified flight communication specialists who dispatch the company’s helicopter and fixed wing aircraft 24 hours a day, seven days a week, 365 days a year. Using a computer-driven algorithm methodology, the communication specialists can quickly determine which aircraft is closest to the scene or facility for immediate dispatch.
To leverage the health care industry’s technology advancements, air medical practitioner training has become increasingly intense and broad. Today all care is data-driven and must meet national standards. This is important to ensure that participating air medical programs continue to provide the highest level of care. For example, Life Link III is accredited by the Commission on Accreditation of Medical Transport Systems (CAMTS), which is the longest tenured accreditation service for critical care transports and its industry standards-setting requirements are akin to what The Joint Commission (JCAHO) is for hospital accreditation.
To leverage the health care industry’s technology advancements, air medical practitioner training has become increasingly intense and broad.
Through its “One Call” system, Life Link III works collaboratively with other air medical transport services to dispatch the most appropriate helicopter, whether it is Life Link III’s or another service. This translates to doing what’s best for the patient on every transport. The referring EMS Agency, hospital medical staff or the patient or patient’s family, determine the mode and where the patient is transported. While distance may be a factor in deciding whether to send a patient by ground or air, many variables must be considered including time of day (avoiding slow rush hour traffic), seriousness of the injury or medical issue, and as previously noted, the level of care needed en route to definitive care.
Combining sophisticated technology, intense training, and rigorous accreditation results in a truly intensive care unit level of tertiary care that can be delivered quickly to any area of the state and region. This has enormous positive implications for the health and well-being, both physically and economically, for Minnesota’s more rural communities.
Innovative technology takes flight To enable a true continuum of care from the referring hospital to the receiving hospital, a broad variety of medications and technology must be quickly accessible and deployed onboard the aircraft. Examples of the data-driven tools Life Link III uses include: Air medical transport to page 294
A flying ICU requires extensive training Like our hospital partners, the continuing advancement of medical technology and innovation requires rigorous ongoing training for nurses and paramedics who are certified in critical care flight transport. Medical crews undergo continuous simulation training throughout the year to remain competent and prepared to deal with any type of situation and patient, including neonates. Flight clinicians need to competently handle infrequent interventions with the same skill and confidence they do with patient complications they encounter more often. This level of efficacy is achieved through continuing education and requires a substantial investment of time and resources to maintain. Consider that in 2016, Life Link III completed 2,098 transports (helicopter and airplane) of which 84 percent were adults and 16 percent pediatric/ neonate patients. The primary impression of these patients at transport were: • Cardiac 26 percent • Neuro 20 percent • Trauma 20 percent • Medical 19 percent • Pulmonary 13 percent • Burn 1 percent • Obstetric 1 percent MINNESOTA PHYSICIAN JULY 2017
Neonatal abstinence syndrome The rising use of opioids during pregnancy BY NICOLE VILLAPIANO, MD, MSC, AND TYLER N.A. WINKELMAN, MD, MSC
he opioid epidemic in the U.S. increasingly impacts some of our most vulnerable patients: newborn infants. Infants exposed to opioids in pregnancy may experience a prolonged withdrawal syndrome, termed neonatal abstinence syndrome (NAS), soon after birth. NAS is characterized by symptoms ranging from irritability, difficulty feeding, and poor sleep, to poor growth, low-birth weight, prematurity, respiratory distress, and even seizures. The rise in NAS has been felt in a variety of communities over the past decade, but some communities have been disproportionately affected. In a paper recently published in JAMA Pediatrics, we examined rural vs. urban differences in maternal opioid use and neonatal abstinence syndrome. Previous work had shown that the opioid crisis impacted rural America in terms of overdose deaths and complications of opioid use disorder, but no studies had described the impact on pregnant women and infants. We found that rates of NAS rose substantially in both urban and rural communities, but rates were significantly higher in rural areas. Using a national database
of hospital discharges, we examined rates of NAS in urban and rural areas between 2004 and 2013. In 2004, rates of NAS were similar in rural and urban areasâ€”about one NAS birth for every 1,000 hospital births in the U.S. By 2013, however, rates of NAS had increased in parallel with rapidly rising rates of maternal opioid use. But the rise in NAS was not evenly distributed. Rates of NAS increased over sevenfold in rural areas, compared to a fourfold increase in urban areas. Similarly, rates of maternal opioid use in rural areas increased from 1.3 to 8.1 per 1,000 hospital deliveries, whereas in urban areas the rates of maternal opioid use increased from 1.6 to 4.8 per 1,000 hospital deliveries.
Maternal opioid use Maternal opioid use and NAS in rural areas is a public health crisis driven by complex social and medical factors. Rural mothers and infants in our study came from counties with lower incomes and often had limited educational and employment opportunities. Individuals in rural communities also have high rates of chronic disease, smoking, and obesity. These social disadvantages and health challenges, in addition to primary care shortages and limited access to specialist services including maternity care, mental health, substance use treatment, and pain management, have fueled conditions for the opioid epidemic to take hold in rural areas. The rising incidence of NAS may at least partially represent the failure of our social service and health care systems to address the social conditions that lead to opioid use. For patients who develop an opioid use disorder, treatment options in rural areas are either limited or simply donâ€™t exist.
The causes of NAS To develop an appropriate public health response, it is important to understand the etiology of NAS. NAS can occur after exposure to any opioid in-utero, but there is also evidence that in-utero exposure to some non-opioid medications, such as benzodiazepines and SSRIs, can lead to NAS. Nonetheless, opioids are responsible for the vast majority of NAS cases in the U.S. The general public, and even many health care providers, may assume a mother of an infant with NAS was misusing prescription opioids or using heroin during her pregnancy. Yet, some mothers who deliver an infant with NAS are intentionally prescribed opioids in pregnancy for medically appropriate reasons. Other mothers who deliver an infant with NAS
Resources for Minnesota Physicians Seeking to Provide Better Care for Patients with Opioid Use Disorder American Society of Addiction Medicine:
4https://www.asam.org Substance Abuse and Mental Health Services Administration:
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may have experienced complications of pregnancy requiring a prolonged hospital stay and medical administration of opioids for sedation or analgesia prior to delivery. Many mothers with a history of an opioid use disorder, are appropriately treated with medication-assisted treatment (MAT) like buprenorphine or methadone during pregnancy, which improves outcomes for mothers and their infants, but does also cause NAS.
Providing a supportive environment Opioid use during pregnancy is highly stigmatized and patients may be hesitant to seek treatment. Patients may fear consequences, both legal and non-legal, from disclosing an opioid use disorder during pregnancy. To avoid disclosure and avoid stigma in their community, pregnant women with an opioid use disorder often have a strong desire to attempt abstinence during pregnancy.
Physicians who encounter these fears should strive to foster a supportive The standard of care for women with opioid use disorder in pregnancy environment for women with opioid use disorders. is MAT. Women who enter a MAT program It is especially important for physicians to before or during pregnancyâ€”either through acknowledge patientsâ€™ fears, provide education office-based buprenorphine treatment in primary regarding the benefits of MAT, and help patients care, a rehabilitation program, or a methadone select an opioid use disorder treatment option that maintenance programâ€”typically have infants best fits their needs. Furthermore, primary care Physicians can prevent opioid with NAS. Although MAT may result in NAS, physicians, particularly those in rural areas, should use before it starts. these mothers are prioritizing their health and the consider obtaining a DEA waiver to prescribe health of their infants. Women with opioid use buprenorphine as part of primary care officedisorders who engage in MAT during pregnancy, based treatment of opioid use disorder. Resources especially buprenorphine treatment, are more for obtaining a waiver through an eight-hour likely to have healthy pregnancies and deliver a buprenorphine training course as well as other full-term infant than those who attempt abstinence materials for starting an office-based opioid use during pregnancy. Abrupt discontinuation of opioids during pregnancy is disorder treatment program are available through the American Society of not recommended for women who are opioid dependent, and in fact, has Addiction Medicine (asam.org). While MAT does not necessarily decrease high risks of harm. Attempted abstinence during pregnancy is associated the prevalence of NAS, treating pregnant women with an opioid use with higher rates of non-medical opioid use relapse, which increases the risk of preterm labor, complications during delivery, and even fatal overdose. Neonatal abstinence syndrome to page 384
MINNESOTA PHYSICIAN JULY 2017
HEALTH CARE POLICY
The 2017 legislative wrap-up The battle over the budget BY NATE MUSSELL, JD
he 2017 legislative session unfolded in a three act play of sorts as the Legislature focused on solving the current crisis in the state’s individual health insurance marketplace before jumping into the difficult task of approving a state budget. Not to be outdone by recent legislative history, the final act of the play in the last week of May played out like a Shakespearean drama as the Governor accused legislative leaders of treachery and sneakiness in signing the final budget bills and then vetoed funding for the ongoing operations of the House and Senate in an attempt to force legislators back to the negotiating table. This was after legislators tied Department of Revenue funding directly to their tax bill. Future legal challenges and uncertainty aside, the 2017 session had the makings of a session unlikely to be repeated anytime soon. The last and only other time Republicans controlled both the House and Senate came in Governor Dayton’s first year in office 2011—a year in which the state saw an almost month-long government shutdown in the face of a $6
billion deficit. The stakes were different this session as the state was dealing with a $1.6 billion dollar surplus, but many skeptics remained on whether the Legislature and Governor could find some common ground by the end of session to avoid a repeat of 2011. The Republican-controlled House holds a pretty comfortable 77–57 majority, but the Republican-controlled Senate saw considerably more challenges this session governing with only a one vote majority of 34-33. At several points during the session, the Senate had to delay action needing every vote possible when a Republican member was unexpectedly absent. As expected with the $1.6 billion surplus, the Republican-controlled Legislature focused largely on a significant tax and transportation package when it came to putting their budget together. But early in the session, the focus was largely on health insurance reforms and funding two major health insurance initiatives.
Act 1: Premium relief and health insurance reforms The Legislature wasted no time jumping right into health insurance reforms with the first bills of the 2017 session. The quick work on a health insurance premium relief package came as no surprise to many as legislative leaders and the Governor had been going back and forth throughout December on whether they were going to hold a special session to provide premium relief for the individual market. After almost a month of quick movement through multiple committees, the Legislature reached an agreement on a premium subsidy program that provided individuals who had purchased or were in the process of purchasing coverage on the individual market with a subsidy equal to 25 percent of their monthly gross premiums. The final premium subsidy program came at an almost $312 million cost from the state’s general fund. Some of the more contentious aspects of the bill came with policy changes added separately from the core premium subsidy program. The most noteworthy change to come out of this bill was the change in Minnesota’s long-standing prohibition on for-profit health maintenance organizations (HMOs). Minnesota was the last remaining state in the country to prohibit for-profit HMOs—a law in place since 1973. It is still too early to determine what impact, if any, this change will have on the insurance market and providers going forward, but this is one to watch closely in the next year. Another provision that was included in the premium subsidy bill was language around “surprise billing.” Surprise billing had become a much talked about issue around the country in the last few years as news stories highlighted seemingly egregious out-of-network bills received by some patients in certain circumstances. The situation of “surprise billing” arises when a patient goes to an in-network facility but then receives treatment from an out-of-network provider. The most oft-cited examples include radiology, anesthesiology, pathology, or emergency room physicians. Ultimately, the language that was passed by the Legislature helps to set up a third-party alternative dispute process in situations where there is a disagreement about payment between an out-of-network physician and a health insurer. The
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final agreement was modeled after similar language passed in New York and other states.
Act 2: Reinsurance
period relying on a combination of yet to be determined federal funding, a transfer of $200 million per year from the Health Care Access Fund, and an additional $71 million from the state’s general fund. However, the entire reinsurance package only becomes effective upon federal approval. The uncertain environment and timeline around federal health care reform adds to the questions about whether reinsurance will prove successful in stabilizing the future of the health insurance market in Minnesota for both patients and physicians.
If the first act in the 2017 legislative session was to help solve the shortterm crisis in the individual market, then the second act came with the Legislature looking to stabilize the long-term status of the state’s individual market. While the Legislature debated the issue of reinsurance throughout February and March, the uncertainty Discussions about the American Health Care of the Affordable Care Act repeal and the Act demand considerately more attention and it American Health Care Act replacement being Budget discussions is still too early to speculate on what form the discussed in Washington, D.C., loomed over their are always contentious. final bill might take. But in the short term, the heads. In addition to reinsurance, some at the Legislature and the health care leaders in both Legislature had discussed bringing back a highthe House and Senate are keenly aware of the risk pool program similar to the now defunct potential impacts of proposals being discussed— Minnesota Comprehensive Health Association. particularly as it relates to the commercial The Governor and DFL legislators proposed an insurance market but more significantly the state’s entirely different approach relying on expanding Medicaid budget and the Health Care Access Fund. the state’s existing MinnesotaCare program to any individual purchasing coverage on the individual market. Ultimately, a reinsurance program was Act 3: Putting together a budget with some overtime agreed to that would see the state help offset the cost of high dollar claims Budget discussions are always contentious no matter who sits in the Governor’s on the individual market with the hope of bringing more stability to the office and which party controls the Legislature. The latter part of the 2017 market and getting premium costs down long term. legislative session was certainly no exception as the Republican-controlled The final agreement that went into law without Governor Dayton’s signature in late March came at a cost of almost $550 million over a two year The 2017 legislative wrap-up to page 364
MINNESOTA PHYSICIAN JULY 2017
47TH MINNESOTA HEALTH CARE ROUNDTABLE
A new approach to care
proteomics, metabolomics, epigenomics, the microbiome—and, even more important, the economics that will determine financing. Third, precision medicine will provide a scientific basis for health and wellness. We hope to find the transition zones between health and wellness and the onset of disease, allowing us, through lifestyle or therapeutic interventions, to introduce the preventive aspect and the underlying molecular perturbations that allow expression of the disease phenotype.
Minnesota Physician Publishing’s 47th Minnesota Health Care Roundtable focused on the topic of Precision Medicine: A new approach to care. Seven panelists and our moderator, Minnesota Physician Publisher Mike Starnes, met on April 20, 2017, to discuss this topic. The next roundtable on November 2, 2017, will address Regenerative Medicine: Efficacy, Economics, and Evolution.
This afternoon we will examine the topic of precision medicine. Let’s start by defining some terms. What do we mean when we say precision medicine? DR. BROWN: Let me start with three areas. Under what is known as P4 medicine, personalized refers to the individual medicine concept, which is predictive as we acquire large amounts of data. Acquiring this data allows us to have a preventive component for early intervention. The last component of P4 medicine is participatory—patients are now actively involved and contributing to the databases. Second, we have to look beyond the genome, and examine the entire sequence downstream from genomic expression. This should incorporate a “multiomic” consideration of genomics: transcriptomics,
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DR. SPIRO: I would add more “-omics.” Things like, “I have to pick up my kid at school-omic so I cannot go to my appointment,” or, “I have a spouse who is sick and I have to provide care-omic.” Precision medicine is personalized medicine from a scienceand genomic-based starting point. For many people, their economics, their family concerns, and their spiritual beliefs trump any biology. Until we consider those factors, we will not be successful in what I will call individualized personalized medicine. Advances in pharmacogenomics may allow us to predict which medications will be most accurate, but some patients are not going to take the medication—they either cannot afford the copay or they just are afraid of it. We must consider social factors and spiritual factors, and start to see people as the complex, unique beings they are. As [Sir William] Osler said, “It is much more important to know what sort of a patient has a disease than what sort of a disease a patient has.” That takes more than biology. DR. HALLING: I think you will hear that it is
nothing new. We have been practicing precision medicine for 100 years. Take lung cancer as an example. In the beginning, we just referred to lung cancer, and then pathologists discovered that there was squamous cell and adenocarcinoma and small cell cancer, and that you could treat them differently. Now, with additional genetic information, we can further subdivide these and develop different therapies. So it is nothing new, it is just getting more and more precise with time. What is the difference between pharmacogenomics and pharmacogenetics? MR. ALLEN: I believe they are largely synonymous.
One aspect of pharmacology examines the clinical effects of drugs on various targets in the body. Pharmacogenetics looks at how your genes influence your response to medications. Genomics tends to have a broader view, thinking about gene pathways and interactions between genes. For the most part, though, they are pretty synonymous. MS. TRUELSON: Pharmacogenomics allows us to
look at the tumor profile, the genomic profile in a given tumor, and choose a chemotherapy regimen that will effectively target that specific tumor. Not just the type of tumor, but that specific tumor in that specific individual. When did we first start using the term “precision medicine”? DR. BROWN: It dates to 2004, when the completion
of the Human Genome Project allowed us to identify genetic variance in a meaningful way and to characterize individual traits. We differ by a very small degree, with perhaps 0.2 percent variability from human to human, but that was enough to define a concept of individuation. The digital revolution occurred concurrently, expanding our ability to accumulate large amounts of data. The establishment of social networks, and then the integration of the electronic medical record, really defined and made the terms “individualized medicine,” “personalized medicine,” and “precision medicine” realities. We could now incorporate and create a medicine that was proactive rather than reactive in the presence of disease. What are some examples of how precision medicine is already in place? DR. HALLING: I see it in oncology. In the case
of lung cancer, Mayo has a panel that looks at quite a few different things simultaneously. Nextgeneration sequencing looks at 20-plus genes— things like EGFR, MET, RAS—and each of those help us make targeted therapy decisions. So if the patient’s tumor has an EGFR mutation, that predicts they will usually respond to specific drugs. In colon cancer, we routinely test for four
GINNY ADAMS, RN, MPH Coverys Ms. Adams, Senior Risk Consultant at Coverys, has a clinical background in critical care and emergency nursing. She is trained in, and has facilitated organization-wide work in, both Lean and the Deming philosophy of improvement. She is committed to continually improving systems and processes to enhance patient safety, outcomes, and care.
JOSIAH ALLEN OneOme
different genes, and those predict resistance to EGFR therapy under certain medications. With molecular oncology, we are seeing 40–50 percent growth of test volume each year, because the targets that we know about increase each day and our understanding of the correlations with response to therapy grow each day. MS. TRUELSON: My background is also in oncology,
but I know that there are other areas where this panel testing is becoming very important for therapeutic reasons. At Ambry [Genetics], our EpiRapid panel has 16 genes where there are therapeutic indications for epilepsy, and we have a similar panel in terms of cardiovascular disease. Neurology and cardiovascular disease are just some examples of where therapeutic indications can be managed based on test results. DR. MENDELSOHN: We can now use genetic
testing to identify children with complex disorders earlier, and the more rapidly we can identify their disease, the more appropriately we can treat them and know which direction to give families. It helps you direct the therapy if you know what else to be doing. For example, a child with Pompe disease, in addition to having cardiomyopathy, has myopathy. That guides the direction we should take with complex medical therapies, particularly for children in our ICUs.
Mr. Allen, Director of Medical Affairs at OneOme, has been involved in clinical research, product development, and clinical adoption and implementation. An author of more than a dozen peer-reviewed publications in pharmacogenomics, he has lectured extensively on clinical applications of pharmacogenomics.
DAVID R. BROWN, MD, FACE Recombinetics Dr. Brown, Vice President of Biomedicine at Recombinetics, is a staff physician at Children’s Hospitals and Clinics of Minnesota, and in practice at Pediatric Endocrinology and Metabolism, Minneapolis. He completed a fellowship in Pediatric Endocrinology and a National Institutes of Health post-doctoral research fellowship in cellular and molecular biology.
KEVIN HALLING, MD, PHD Mayo Clinic Dr. Halling is Co-Director of the Genomics Laboratory, DLMP, at Mayo Clinic in Rochester. A molecular pathologist and professor in Mayo Clinic’s Department of Laboratory Medicine, his primary area of interest is in the development of genetic tests that can be used for the diagnosis and treatment of sporadic and hereditary cancer.
NANCY J. MENDELSOHN, MD Children’s Minnesota Dr. Mendelsohn is Director of Medical Genetics at Children’s Minnesota. A board-certified medical geneticist, she has more than 50 peer-reviewed publications, book chapters, and presentations in top-tier journals. She is a recognized thought leader in lysosomal storage disorders and a Fellow of the American Academy of Pediatrics (AAP).
DR. BROWN: The defined genetic variants that
we can clinically correlate account for about 2.5 million nucleotide sequences—but remember, there are 3.5 billion base pairs throughout our DNA sequences in each of our single cells. New technologies address that with mass parallel screening, and one new system allows us to do a whole genome sequence in parallel in about 14 minutes, with commercial costs estimated to drop down to $500 within five years. As important as the genome is, though, I think that proteomics are going to be much more important. We have the ability to biosynthesize something on the order of 250,000 proteins, and proteins are able to do an amplification of the genome well over 1000- or 2000-fold in terms of genetic information.
ALAN SPIRO, MD Medica Dr. Spiro, Senior Vice President and Chief Medical Officer at Medica, oversees Medica efforts to improve the quality of health care while managing costs. He emphasizes new models of collaboration to achieve those goals. His experience includes executive roles at health plans and health services businesses, as well as in clinical practice.
MELISSA TRUELSON, MS, CGC Ambry Genetics Ms. Truelson, Certified Genetic Counselor at Ambry Genetics, specializes in variant assessment and result reporting as a cancer genetic counselor. She is a member of both the National Society of Genetic Counselors and the Minnesota Genetic Counselors Association, where she currently cochairs the Public Policy Committee.
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DR. SPIRO: I want to put the economic lens on
this. Five hundred dollars sounds cheap for a mass screening, but multiply that by every single person you will screen. From the insurance world I live in, you have now increased the cost of premiums by at least $500— probably much more, because you are also going to be dealing with follow-up care. You also have to consider pharmacologic technology. The more precise your targeting of drugs, the more opportunity for new patent medications, with average costs that may well exceed $1,000 or $10,000 per dose. It might be crass to talk about the cost issues, but they are real.
of those diseases did not involve any pharmacologic intervention—they involved lifestyle and nutrition, so the cost of therapeutic intervention, from the preventive aspect, was economically reasonable. What are the biggest challenges we face in making precision medicine part of everyday medicine in every clinic? DR. HALLING: Consider the terms clinical validity and clinical utility. You could have a sound test, one that is sensitive and specific—one that is clinically valid—but when you use it in practice it
DR. MENDELSOHN: There are 67,339 tests now available that test for 4,974 disorders. Our job as clinicians is to make sure that we do the right test at the right time. In our institution, every single DNA-based test is reviewed by a genetic counselor to make sure that we are not overspending, but we can still save money if we get upstream of the diagnosis and do the right test. I believe it is premature to utilize proteomics clinically, but there are great gene tests and some good panels ready today that we can use for our patients. DR. HALLING: Regarding this insurance issue, it’s my understanding that the testing expenses are a drop in the bucket compared to the pharmaceutical expenses. A lot of our testing presents an opportunity to avoid giving expensive drugs to patients who will not benefit from them, especially in cases involving immunotherapies and some targeted therapies. There needs to be a lot more work done on cost benefit analyses. MR. ALLEN: One new pharmacogenetic study
involving 1,000 patients showed that 99 percent carried at least one actionable variant among five genes—so everybody in this room, basically, carries at least one actionable variant in one of five genes. When you consider the cost of testing and insurance, this has the potential to impact a large number of patients. We are going to have to think very strategically about how to implement this in a cost-effective manner and also to ensure that we help people avoid adverse events. DR. BROWN: In the Pioneer 100 Project, 4,200-odd
associations that were never appreciated before were identified in 108 randomly selected individuals. In 60 percent of those patients, early determinants of disease were identified that typical medical interventions did not interpret. Eighty-five percent
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medicine consists in amusing the patient while nature cures the disease.” Sometimes watchful waiting is the best thing for the patient—this is still a valid therapeutic and even diagnostic technique. We have this fundamental belief—a very American cultural belief—that all illness and death is optional. Maybe it will be someday. But right now, as we try to stave off all illness and death, we are making medicine unaffordable and unavailable to vast parts of the population. MS. TRUELSON: The world would be a better place if all human disease was understood, and the only way to do that is to collaborate and share data. There are lots of labs and research groups that hoard their data. Ambry has published several large papers recently, one in collaboration with Mayo that showed that some hereditary breast cancer genes may not confer the type of risk that we thought they did. None of that would be possible without collaboration. MS. ADAMS: Where does research stop and start and clinical care stop and start? We all judge care on the evidence-based best standard—what we accept as best care at that moment—and that standard is developing so fast. Somehow, we have to restructure and figure out how to use this knowledge to drive clinical care, to use outcomebased information to drive more research and more care. It’s a cycle, and collaboration is key.
lot of our testing presents an opportunity to avoid giving expensive drugs to patients who will not benefit from them. — Kevin Halling, MD, PhD
may or may not change patient management, so it is just a waste of money. We need more studies, but it is a very high bar to pass, and frequently there are not enough patients at any one institution to accomplish it. Sometimes different institutions have to partner together. For genetic tests, they want to see evidence not only of analytic validity, but also of clinical validity and clinical utility. DR. SPIRO: When I did training, I would teach
people what I call the “secrets of medicine,” one of them being that 80 percent of illnesses get better on their own. As Voltaire said, “The art of
DR. SPIRO: We need more clinical geneticists,
physician geneticists, and genetic counselors, but the economics of it are lousy. The money in genetics is in lab testing and in potential genetic therapy. There is no money in the clinical practices. That’s just a fact, even though geneticists go through training that is akin to that of neurosurgeons. The representatives on this panel are making tremendous advances, but if you are an entrepreneurial company, you deal with investors and venture capitalists who want their 30 percent return each year. You need profitability or growth or both—and, again, that means high-priced labs. How can we best update doctors and other members of care teams about advances in precision medicine? DR. MENDELSOHN: We partner deeply with our clinicians so that, in each of our specialty areas, we have a particular physician who has an interest
in genetics and genomics, and we have genetic counselors that we embed in our specialty clinics to partner with those clinicians. They interpret the tests and help empower the families with information. Equally important is the expertise of clinicians. Some practices, particularly at Sanford in their system in South Dakota, have done a great job integrating genetics in the primary care setting. Let’s talk about genetic counselors. What do they do? What training do they have? How do they fit in? MS. TRUELSON: Most of us work in clinics
alongside physicians, nurses, and other members of the health care team, meeting with patients and families. We gather family health histories to do a risk assessment for given hereditary diseases, and, if testing is done, we help interpret results for the patients and their families. Some genetic counselors, like me, work in industry or for laboratories, analyzing test results and assessing variants that we identify in people’s genes to determine if they are pathogenic or if they are harmless and issuing reports back to the physicians or genetic counselors who ordered them. Our training requires a two-year, accredited Masters program, followed by a board exam to be certified. Minnesota was the 22nd state to pass a genetic counselors licensure law. Starting in 2018, genetic counselors must be licensed in Minnesota. MR. ALLEN: When I interact with patients and clinicians, I get more questions on the drugs than I do on the genetics. We really see pharmacists as the people who will be the ultimate owners of pharmacogenomics. Pharmacy is, I believe, an underutilized resource on the health care team. These folks do four years of school entirely focused in pharmacology and pharmacotherapy, and then they count pills at Walgreens. I think we could do health care a great service by increasing their role, and pharmacogenetics is one of the things that they could ultimately own and bring to the table. DR. MENDELSOHN: I could not do my job without
a genetic counselor. When I came to Children’s, I asked that our genetic counselors be part of our professional staff. We now make sure that, even though they are embedded into the specialty clinics, they also come back to the genetics department to share information with colleagues
and with our pharmacogenomicists. Having that team to share information and disseminate it into the frontline has been critical for success. DR. HALLING: We probably have 30-plus genetic counselors at Mayo, at least 20 of them in the laboratory and maybe 10 or more in the clinic. Our head genetic counselor told me there are only 250–300 counselors graduating each year, even though there are 2–3 times that many positions available. Salaries for genetic counselors are higher with the laboratories, especially commercial labs, than they are in the hospital setting. MS. TRUELSON: The NSGC [National Society of
could not do my job without a genetic counselor.
done to support genetic counselors in the clinic and to keep them there. DR. HALLING: We went live with whole exome
sequencing about a year ago. Genetic counselors helped us interpret a lot of the data before it went to the lab director for final reporting, but it is hugely labor intensive. It can take a week to look at a case with one person, and that drives up costs. How can we build reimbursement for genetic counseling into the system? DR. SPIRO: There are many challenges, including the problems of getting genetic counseling and genetic expertise into smaller hospitals and smaller settings. Larger systems gobble up hospitals and clinical facilities all the time, and it becomes a contracting and business relationship—buying supplies is cheaper, and it is easier to contract with a managed care plan. We need the systems to step up and have true clinical integration of what they are doing. We need the managed care companies and the hospital systems to understand that, from a financial point of view, medicine is now team-based. When it comes to reimbursement, old-fashioned fee-for-service still rules the day, and that’s a major problem. Unless we recognize team-based pay appropriately, we will be behind the times in how we pay people, and our payment systems will get in the way of incorporating, not just genetic counselors, but pharmacists and other health care professionals in a meaningful way. DR. MENDELSOHN: You can only do that if you
— Nancy J. Mendelsohn, MD
Genetic Counselors] invested in a workforce study to address the shortage of genetic counselors, and training programs are looking at ways to graduate more students. When genetic counselors change jobs, the vast majority go from clinic to lab, not the other way around. When you look at professional status surveys, the reason for that is primarily job satisfaction relating to salary and—I’m going to get on my little soapbox here—administrative support. I know genetic counselors who are still addressing envelopes, getting their own records from other clinics, and spending time faxing things. There are some little things that can be
are clinic-based. If you are a hospital-based clinic, you can’t. There are regulations around that, so we can’t bill for our counselors. And even when you do, which we have tried in the past, it is less reimbursement than the facility fee. MR. ALLEN: The problem is the same in the
pharmacy world, where you have pharmacists who are not considered providers, so they are not able to prescribe or order testing. They have to do all of that under the supervision of a physician, and are not able to operate independently. There are certain medication therapy management codes that they are able to bill, but those do not pay well and so it is not financially feasible to integrate those types of pharmacists into the system. We need to find ways to make the value they bring match the reimbursement that comes back.
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DR. SPIRO: This will sound offensive, but when
you talk about reimbursement, it is a negotiation between large health systems and large payers. I would love to see the clinicians within the large health systems lobby to place more value on clinical services than on the facility fee. It’s a zero sum gain, obviously, but that’s what’s happening. Health systems are demanding certain prices for a facility fee and for other types of fees. For inpatient care we negotiate much more on DRG [diagnosis-related group] payments, but I’d love to see the health systems come to us and say, “We have to change our internal value system. We have to value the work of the clinicians much more, and we want our pricing to reflect that.”
clopidogrel, or Plavix, a blood thinner given to patients who have had heart attacks. In about 25 percent of the population, a genetic variant predisposes that medication not to be effective. In those patients, there is a 50 percent greater chance of heart attack or stroke than in patients who do not carry the genetic variant, and some of them go back to the hospital within 6–12 months with another heart attack, simply because the medication we prescribed was not effective. We could have known that going into it and prescribed them other medications that would have been efficacious. We also need to consider reimbursement. When I’m out talking
reason we do not have these people on the front line working with our patients. I think that it is tied very closely with the whole culture of medicine. It is a physician-driven model, so you have to get your physicians to a point where they are willing to share that “captain of the ship” role with all these other people who are so critical to the patient’s care. It all has to evolve together.
DR. SPIRO: We have to get a whole different payment mechanism. There are lots of different ways to reimburse for health care. The first thing to understand is that we do not have a health insurance system in this country. Insurance is the idea of pooled dollars to cover the risk of unlikely events. Part of what we have is insurance, but mainly what we have is prepaid health care, and that’s different from insurance. There are certain societal decisions that have to be made in terms of how you spend that money for prepaid health care. Right now, we are dysfunctional in how we make those decisions.
How do we get precision medicine into the mainstream of day-to-day health care delivery? MR. ALLEN: I’ll give you one example involving
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DR. MENDELSOHN: In precision medicine and in
anything involving genetics, we have to remember the importance of privacy. If you evaluate one family member, you may indirectly be evaluating another family member. If you have a first cousin to a child and you do a genetic test and it is positive and they both have the same abnormality, you have just diagnosed both of their parents without doing a single test.
MS. ADAMS: You talked about payment as the
This might be a good time to discuss the shortterm future. Where will precision medicine be in three years, and how will it get there? How can we go from a place where we cannot afford to practice precision medicine to a place where we cannot afford not to do so?
create more realistic disease models by inserting human genes into larger animal models that are much closer to us, both physiologically and genetically. Most of you know that if you look at the 10 or 12 most currently prescribed drugs, it is hard to find efficacy greater than 20 percent in many cases. We are dealing with a flawed biology that underlies our whole pharmacotherapeutic science. I am currently engaged in creating a much more valid biology that underlies drug development and gets drugs to market that have efficacies in the 80–90 percent range and have safety profiles that approximate those same percentages.
What does a patient need to know about precision medicine?
e are dealing with a flawed biology that underlies our whole pharmacotherapeutic science.
— David R. Brown, MD, FACE
MR. ALLEN: First, genetics does not mean everything and it is not deterministic. It may be because of the movie “Gattaca,” but there’s this societal thought that genetics is 100 percent deterministic and that my genes control my destiny. If we can dispel that myth today, we will have done a huge service. Second, there obviously are big concerns about privacy, as well as fears and misconceptions. MS. ADAMS: Patients should know this is
to providers, the first question is, “What is pharmacogenomics?” and the second question is, “Is it covered?” DR. BROWN: There is another dimension that
contributes to cost effectiveness. Drug development and pharmacotherapeutics are partly predicated on outdated rodent models. The vast majority of drug development/drug testing goes on in murine models (mice genomics), which have little or no homogeneous relationship to the human genome. It’s a poor model for drug development and therapeutics. At Recombinetics, we attempt to
available. I live in the rural part of the state, and these sorts of things are not front and center. We need to raise awareness of what is available, as well as its limitations. As we just discussed, genetics is not deterministic, it is one piece, along with lifestyle choices and your environment. Patients should be aware, before testing even starts, of the privacy implications, the unforeseen information that may be identified, and all sorts of other things. They need to know the possible impact on their medical care, not only medically, but financially, emotionally, and socially. With all of medicine, we have been trying to bring the voice of the patient to the table as we develop things in
our hospitals, clinics, and communities. We must not forget, as we move forward, that the patient is a key contributor. MS. TRUELSON: Not all tests are created equal.
The $250 pharmacogenomics test that Josiah’s company can offer is very different than a $250 test that my company could offer. They just look at different things, and that is not always apparent to the general public. Even if you dig deep into some company’s website, you may not get the full picture of what is available. Do we need precision medicine advocates?
DR. MENDELSOHN: One of the difficulties is
looking at how personalized medicine or genomics applies to large populations, and then applying that information to individual patients with complex disorders, particularly children. These are two very distinct populations. It’s important to stop and think about what a test is for and what population you are looking at. Looking at pharmacogenomics in adult populations or studying whether one drug is effective is important. But then if you look at pediatrics and you look at children, at the medically complex disorders in that small group of individuals, it actually is responsible for a huge amount of cost. That is where we can have
DR. SPIRO: We do need patient advocates. People
want help to get through a horribly difficult health care system. Also, the question of what patients should know starts with what doctors should know. Doctors should know what is important to the patient, and they often do not. For some patients, the diagnosis is not the most important thing, and for some patients, the biology is not the most important thing. Many studies show that, when you inform patients about statistical probabilities and the risk ratios of tests, it makes no difference in their decision-making. It takes a distant second to what their friend has told them. We have to understand what the patient is basing their decision on, and then the patient should know whatever else they need to know to make the best decision. DR. BROWN: Patients do not only want to know
what defective gene they have or what particular disease they could be facing. They want to know how well they are, how free they are of certain disease processes, and they want someone to explain the statistical certainty. We talk about medical care, but the term health care is even more relevant if these tools can define health in terms of both wellness and disease in a realistic and meaningful way. I am all for finding people to guide patients through this process. You need the expertise of specialty physicians to decide what tests to order, but once that process is complete, I believe we can have patient advocates guide that process, do the interpretation, and enhance compliance. It is one thing to make a diagnosis or to prescribe a therapy, but it is very, very difficult to maintain that compliance factor to optimacy. That is often a big factor when you consider the efficacy of drugs or of lifestyle interventions.
e did follow-up testing on people who had had directto-consumer testing, and there was a 40% false-positive.
— Melissa Truelson, MS, CGC
but we had a patient with CRIM-negative Pompe disease. Children with this disease have no nascent enzyme, and the body then attacks the enzyme, so when we give them exogenous enzymes or enzymes from outside the body, their bodies attack the enzyme. We developed a mechanism and a treatment for that particular child that we were then able to expand to other diseases. The opportunities to do that in a clinician’s lifetime are very few and far between. If we shared data and had the opportunity to look at pathways, we could learn a great deal. Should there be increased consumer protection for over-the-counter products that claim quasimedical validity related to genomics? MR. ALLEN: That’s a timely question. I believe that, without exception, every single one of the genes on one new panel marketed to consumers has an American College of Medical Genetics [ACMG] recommendation against testing for it. The questions that the FDA asked this company when they were seeking approval focused on whether any harm would come to patients, and did not really ask about the benefits of providing that information to patients. I was not particularly thrilled with how the FDA handled that particular incident. It is odd for me, being somebody in the laboratory industry, to be saying that, but I think that there do need to be protections in place. I have heard that there is a lot of snake oil out there, and the issue of clinical validity and clinical utility is really important. There needs to be some sort of oversight, some group that studies it and says whether these tests are helpful, not just whether they meet the bare minimum of not doing harm. MS. TRUELSON: Even the bare minimum of not
a tremendous cost/benefit ratio and the ability to take those medically complex patients and funnel them through a genetics system. MS. TRUELSON: You just described a genetic
counselor, a patient advocate who holds the patient’s hand through the process and helps them determine what is most important to them. I cannot tell you the number of times I walked into a room knowing what test I was going to order for a patient and then left not ordering anything because it was not what they wanted. DR. MENDELSOHN: This is a very esoteric example,
doing harm might not be met. A group of genetic counselors at our company just presented an abstract at ACMG where we did follow-up testing on people who had had direct-to-consumer testing, and there was a 40 percent false-positive rate in genes like BRCA and TP53. BRCA genes increase risk for breast cancer and ovarian cancer, and TP53 causes a very, very severe hereditary cancer syndrome. So the false-positive rate is a little scary. DR. SPIRO: There is also a consumer demand for
insurance carriers to pay for some tests that may
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have no clinical validity. From an administrative expense point of view, the appeal processes are significant, which is fine because due process should be done, but clearly, if there were better mechanisms on the front end to define clinical utility in general—not just for genetic tests but for a lot of other services as well—that would be extremely helpful. DR. HALLING: Both CLIA [Clinical Laboratory
Improvement Amendments] and the FDA require IVD [in vitro diagnostic] manufacturers, if they are going to market a test, to determine its analytical performance, characteristics, accuracy, reproducibility, and analytical sensitivity. Before you can sell a test as a kit, for instance to other laboratories, you have to establish all that to get FDA approval and clearance, and then include it in the package insert. For laboratory-developed tests that are not FDA approved, and for reference laboratories, you should be able to visit their website and see what the analytical performance characteristics are. It is sort of a black box, because sometimes you do not know how the test performs, since they consider it proprietary. That does not even begin to address clinical validity/utility. DR. BROWN: There is a serious deception in those direct-to-consumer testing services. As bad as the genomic testing may be, the companies are really looking at the value to themselves of accumulating data and gleaning data and then marketing it. They are actually selling a $99 test to you that is costing them $400 to conduct, but collectively they may be retrieving $1,000–$1,500 by selling the collected data anonymously. DR. HALLING: There needs to be some assessment
of the risk to the patients when they interpret the results by themselves. If it is too hard for them to understand by themselves, then you need a health care provider in between. DR. SPIRO: Remember that these tests give risk
profiles. They don’t give positives and negatives, and yet they are interpreted as positive and negative by many physicians. The patients themselves are also looking for answers, and we have to be careful of that. Also, in an era where electronic medical records are transferable and there may be breeches of security, we have significant privacy issues. Many people don’t pay attention to privacy when it comes to their own data, because they don’t really understand the downside risk. There is also a small minority who
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just want nothing to do with electronic records. What can be done to prevent precision medicine from creating a new level of social disparity in health care? DR. SPIRO: There is a tremendous risk of that,
and it is already being seen. For several years, India has had a problem with selective abortions of female embryos because of the cultural bias towards male children. That is one example of genetic information—in this case, ultrasound information—having a social impact.
MR. ALLEN: Virtually all new drugs are tested
and approved in Caucasian populations. There is a lot of disparity in how pharmaceuticals work in people of different ancestral backgrounds, and pharmacogenomics provides an opportunity to understand the molecular and biological basis for that disparity and address it. For example, the immunosupression drug tacrolimus works one way in the Caucasian population and is much less effective at normal doses in African American populations, because they have a particular gene variant that makes them metabolize that drug much more rapidly. Pharmacogenomics can help us use that drug more effectively, because we can test for that gene and dose the medication appropriately. DR. BROWN: In my lifetime, all new technologies—
e need to make precision medicine known to people and to make it available. — Ginny Adams, RN, MPH
DR. MENDELSOHN: I’m more concerned about access to testing—whether people believe they can afford it, and whether they have access to insurance. One of the beauties of being in an organization that cares for all children and serves multicultural children is observing how different cultures accept children with differences. One of the great things I’ve learned from our Somali families and our Hmong families is that they are so accepting of kids with differences and kids with special needs. But I worry about them having access to the same kind of testing, particularly for those families that do not have insurance.
computers, compact discs, and large screen televisions—have been accompanied by social disparity. I remember being harangued years ago in a record store because I was buying CDs, which at that time were three times the price of analog records. I was called an elitist. All new technologies can create disparities, but technology related to precision medicine may lead to cost reductions, and not just because it will become more common. Technology will approach issues from multiple directions, from drug development and different strategies to training new health care professionals. All of this will reduce cost and limit liability, which will further reduce cost. I’m hopeful that this will be a democratizing process. We will look back in 25 years, when we have true, operational precision medicine, and see that this was smart and cost effective, and it has brought better health and better wellness to everyone. DR. HALLING: Intuitively speaking, I totally agree,
but there are very few studies that demonstrate reduced costs. You read about cases involving children who had workups for two, three, or four years without a diagnosis, and then they got exome sequencing and their doctors finally arrived at a diagnosis. If they had received that exome sequencing at the beginning, it would have saved a lot of money. There are other anecdotal examples of how you could use the technology to save money, but it’s not absolute proof. DR. SPIRO: My rose-colored glasses are not quite as rosy as yours. Of course, I hope that this leads to better care and lower costs, but as I look around this panel, I don’t see any ethicists, I don’t see any sociologists, and I’m concerned. I’m in the
insurance industry, where underwriting was once a major factor. Even though we’ve eliminated most of the medical underwriting, there is still a risk of using data like this to exclude people from services. What are some of the most important considerations about ethics and professional liability as they pertain to precision medicine? MS. TRUELSON: One of the big ethical issues is how we obtain truly informed consent before testing even begins. With the myriad of tests that are out there, and the complexity of those tests, will patients really understand what they could get back from a test result, and how that result could impact their relatives? And whose responsibility is it to notify these relatives who may be at risk? Is it the physician? Is it the patient? That needs to be discussed beforehand.
determing who we test and when we do so, and what we do if we do not test. It is important to me to make sure that we are doing things for children and not to children. If you have an answer that indicates a child may or may not survive, should you be doing the cardiac surgery or putting them on ECMO [extracorporeal membrane oxygenation]? What about when families disagree with a physician? For me, any good genomics program needs to have an ethicist involved. MR. ALLEN: We have a panel that covers a number of
different disease states and so, if a psychiatrist orders our test, they will get additional information about
DR. HALLING: I see this with oncology patients. If
you’ve got a patient with advanced melanoma and you identify a BRAF mutation, which suggests that they will respond to vemurafenib, you give them the drug. Yes, the drug will eradicate the tumor for 6–12 months before it comes back, so you have bought a little time, but ultimately they are going to pass away unless immunotherapy works. You don’t want to withhold therapy from somebody who might benefit, but how much benefit has truly been derived? It comes back to what we can afford. Any one of us would want a chance. DR. SPIRO: There is a real tension between individual ethics and population ethics. From a population ethics point of view, if you have just a set amount of resources in society, you could argue that no one over a certain age should have dialysis, for example. You could argue that six months of life under an extremely expensive protocol is not a societally ethical point of view, because that same money could be used for X-number of high risk maternity patients. From an individual ethics point of view, if I’m the patient, or if someone I love is the patient, I would want everything done. Insurance carriers and other payers are often left in the difficult position of being arbiters of what they will pay for. That is probably the wrong place to have it, but that’s where it sits today, or with government, which is also the wrong place. DR. MENDELSOHN: There are also the ethical
issues associated with deciding to test or not test,
drug, and that my doctors could have known that would happen if they had tested my genes before prescribing it? Not today, because that testing isn’t accepted practice and we’re not doing it routinely, but at what point will it happen? Right now, we decide malpractice cases based on expert opinion and the best judgment of our physicians. Are we looking at a future where that will no longer be the case—where, instead, malpractice cases will be decided based on the data available about the condition or the drug at that moment in time? Lawsuits happen years after the actual event. In this rapidly evolving world, how do you look back five years and guess what was actually known and what was the standard of care at the time? Does it become incumbent on physicians to use, not so much their professional judgment and experience, but to pull up the data and treat the patient based on the data? And how do we ensure that every physician has the most current and the best data? MR. ALLEN: One very interesting case going before
here is a real tension between individual ethics and population ethics. — Alan Spiro, MD
genes that might affect drugs that are outside of their specialty. There are a lot of concerns about that.
the Supreme Court concerns a patient whose testing identified a particular variant. At the time, they didn’t know the significance of that variant, although it was being studied by the company. Years later, they found that the variant was pathogenic, and that certain people in the company were doing research in that particular area but had not yet made a definitive call. This will be a very interesting court case, because it will raise questions about the responsibilities of the laboratories and the people who study and identify particular variants to report new findings. DR. SPIRO: We often do not recognize that facts
change, including facts involving genomics, proteomics, and other gene expression issues. I used to say that what I did professionally was to translate the black and white of insurance contracts into the shades of gray of medical practice. That’s not easy, but that’s what we’re really talking about. Lawyers will say there are shades of gray in law, but it is a lot less than it is in medical practice.
In terms of professional liability, one of the benchmarks is always the definition of the standard of care. Does this new genomic precision medicine redefine the standard of care, and how will that impact potential malpractice cases?
Life-saving and life-enhancing advances happen faster than they can be assimilated into the delivery system. What are the most important things that we must do to expedite this process?
MS. ADAMS: If I bled to death after taking a certain drug, could you argue that it was because of that
sequence. Moving forward, the challenge will be to marry the data with the clinical phenotype and to
DR. MENDELSOHN: Lots of laboratories today can
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47TH MINNESOTA HEALTH CARE ROUNDTABLE
interpret it with the software. Data will probably live in a secure cloud, to be pulled down into the electronic medical record. For pharmacogenomics, we could start with drug-drug interactions and drug-gene pairs. For clinical genetics, it could be early on, when we make definitive diagnoses. But moving forward, when should we reanalyze the data, and how will we pull that data in? What’s the right software to use? What’s the standard of care? MR. ALLEN: I think there is an ethical and professional responsibility for industry to provide education, provided it’s done the right way. There have been abuses of that system, so we need to build up trust again on both sides. There are often policies in place that make it difficult for industry to get in and talk to providers. One psychiatrist out in Columbus, Ohio, told me it’s really difficult to work with residents coming out of Ohio State, because they don’t know anything about the new drugs. They are 10 years behind, because they don’t let the reps in or the medical affairs folks in to provide any education about the new stuff that is coming out. Some of that is for legal reasons, but I think more is due to the policies within health care institutions. We have to rebuild some trust so that we can work on that together.
Can value-based reimbursement methodology play a factor in expediting this assimilation? DR. SPIRO: It certainly can, but again, there is
danger lurking behind each of these opportunities. In the past, attempts at different reimbursement strategies have had problems. Back when we capitated primary care, some people said it would be the future of medicine. The idea was that we would understand the financial risk and would be able to manage it, and then direct care toward the highest utility. Instead, individual practitioners often misinterpreted it as saying, “Oh my god, I only have $8 or $50 per member per month to treat this patient,” when that wasn’t the case. So we clearly need value-based pricing. We clearly need bundled payments of different types. Perhaps we also need capitation of some sort, but we need it with the right systems in place to make sure that it is being used responsibly and that it’s getting the correct results. As we’ve seen today, precision medicine covers a lot of ground and offers both challenges and
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hope. What are the most important things we need to understand about precision medicine? MR. ALLEN: Precision medicine is not 100 percent
and it’s not deterministic, but that doesn’t mean it’s not useful. It is available today and the costs are rapidly going down to make it more and more affordable. Obviously it comes with a lot of benefits, but it also comes with some challenges. We need to do a lot of work to increase education, both within the community and among providers, to understand how can we take precision medicine and harness it for the betterment of society and health care.
me that we are calling it precision medicine. We put too much weight on it, and we leave out the sociologic and economic factors. Is precision medicine individualized medicine? Not really. It’s a component, and we have to understand how it fits in to everything else we do. We have to understand the ethical considerations. We have to understand how the payment systems will deal with this, when many of the labs and pharmaceutical companies are making tons of money off this and putting a burden on the entire system. Of course, they also contribute to the entire system. When you deal with certain pharmaceuticals and you can eliminate a lot of other hospital costs and surgery costs, from an economic point of view that’s great, but we have to figure it all out. MS. TRUELSON: Interpretation matters, and
collaboration is extremely important. You may get one test done at a given point in time, and we know we can tell you one thing about the results, but that may change five years down the road. It’s important for people to realize that as we get smarter, how we interpret test results and what we do with them may change. Again, collaboration is key. We need to stop hoarding data. We need big laboratories and big research groups to share their information and collaborate so that we can give the best answer to the patients to effect positive outcomes.
here are often policies in place that make it difficult for industry to get in and talk to providers. — Josiah Allen
DR. HALLING: It is a really exciting time. New discoveries are coming out at such a rapid pace, and it is very exciting, from a scientific point of view, to be involved with all of this. But there obviously are a lot of economic and ethical dilemmas that we will have to deal with over the coming decades. MS. ADAMS: I think that we need to educate
DR. MENDELSOHN: The potential is there for us to
save lives, but we have to be judicious about when we do testing. We have to be careful about the promises we make and about our interpretations. Precision medicine is not a panacea. The potential to treat people and improve their disease state is there, but it’s not all ready for prime time. We have to be careful moving forward. DR.
SPIRO: Words matter. I’m actually uncomfortable with the term “precision medicine,” and that’s because so many parts of our definitions are still so imprecise. It worries
patients. We need to make precision medicine known to people and to make it available. We need to provide patients with resources, and then we need to find ways to get them engaged and partnered with us, because everything you read says that it is more essential than ever for patients to be active partners in what we do. We’ve tried to make that happen in health care, and we’re making slow progress. It may be that we have to get very good in a hurry with engaging patients and bringing them around the table. DR. BROWN: My colleagues have done an excellent
job framing everything, so let me leave you with this. We’re going to make medicine great again.
3Air medical transport from page 15 • The Hamilton-T1 Ventilator is a critical care ventilator that deploys a lung protective strategy for patients from neonate to adults. This ventilator allows flight clinicians to use the same ventilatory strategy that will be used in the critical care unit of the receiving hospital. • Circulatory support devices such as intra-aortic balloon pumps and ventricular-assist devices. Life Link III is also capable of transporting patients on the cutting edge Maquet Cardiohelp machine, which is the smallest, most portable extracorporeal membrane oxygenator (ECMO) device in the world. This machine is used for patients requiring circulatory or, both circulatory and respiratory support, and is widely used in this region of the country. • Point-of-care ultrasound (Sonosite IVIZ). This technology has many out-of-hospital applications including, assessing fluid status, evaluating lung and cardiac function, and assessing for abdominal bleeding. Just as in the hospital, ultrasound provides flight clinicians with ultrasonic guidance for procedures such as thoracostomy, pericardiocentesis, IV insertion, as well as guiding fluid resuscitation. • Point of care laboratory testing allows flight clinicians to identify issues such as sepsis, electrolyte disturbances, and guidance of ventilator utilization to optimize blood gas chemistries prior to arrival at the receiving facility.
following member-owners: Allina Health, CentraCare Health, Children’s Minnesota, Essentia Health, Fairview Health Services, Regions Hospital/ HealthPartners, Hennepin County Medical Center, St. Luke’s, and Sacred Heart Hospital. Life Link III operates six helicopter bases in Alexandria, Blaine, Cloquet, Hibbing, and Willmar, Minnesota, and Rice Lake, Wisconsin. By mid-2017, a seventh base will be in operation in Brainerd, Minnesota.
R.J. Frascone, MD, is medical director of Regions Hospital EMS, which includes the City of St. Paul, Life Link III (rotor and fixed wing transport), and 26 other agencies. He is professor of emergency medicine at the University of Minnesota and has worked in the emergency department of Regions Hospital for 39 years. He has been a leader in regional, state, and national EMS and is a past chair for the Emergency Medical Services Regulatory Board for the state of Minnesota. His research interests include airway management, CPR, intra-osseous access, and shock.
Kolby Kolbet, RN, MSN, CFRN, CMTE, is vice president of Clinical Services for Life Link III. He is a Certified Medical Transport Executive (CMTE), Certified Flight Registered Nurse (CFRN), and Nationally Registered Paramedic (NRP). He currently serves as faculty for the Medical Transport Leadership Institute (MTLI) and is an active member of the Air & Surface Transport Nurses Association (ASTNA).
• Mechanical CPR is a vital tool in the air medical transport environment. Due to space restrictions in the cabin, flight clinicians would have difficulty achieving adequate depth and rate of manual compressions. Use of the LUCAS 2 Chest Compression System allows flight clinicians to cognitively offload the physically demanding task of CPR. This allows clinicians to focus on advanced cardiac life support to best manage the patient. • Use of video laryngoscopy in the form of Storz CMAC system is the standard of care to guide successful intubation for both adults and children. • Access to blood. Studies have shown that the immediate availability of blood in the pre-hospital setting has a very positive impact on survival. Life Link III was an early adopter of carrying two units of packed O-negative blood onboard all aircraft. The air medical industry has embraced its role in providing outcomesbased medicine, paralleling its hospital partners. By implementing innovative bedside technology in the air medical setting, flight clinicians are able to leverage data-driven information to provide seamless, optimal care. Our shared goal of continuity of care translates to improved outcomes that benefit the referring hospital, the receiving hospital and, most importantly, the patient. The emergency medical needs of an aging U.S. population, especially in rural areas, will continue to drive new health care advancements. Air medical services providers are well suited to bring patients to technology and bring technology to patients through innovative new approaches. Life Link III (www.lifelinkiii.com) provides helicopter and airplane services for rapid on-scene emergency response and inter-facility transport for patients requiring critical care. Life Link III is a nonprofit company comprised of the MINNESOTA PHYSICIAN JULY 2017
PROFESSIONAL UPDATE: ORTHOPEDICS
Direct anterior hip replacement A minimally invasive procedure BY DAREN WICKUM, MD
egardless of a person’s age, quality of life and mobility are priorities for most Americans. After all, who wants to be slowed down or limited by injury, arthritis, or chronic pain? Fortunately, medical and surgical advancements, particularly in the area of total joint replacement, are making quality of life and mobility possible for a growing number of people. The American Academy of Orthopaedic Surgeons states that between 2000 and 2009, the number of total hip replacement surgeries in the U.S. increased 73 percent. According to the U.S. Agency for Healthcare Research and Quality, more than 300,000 total hip replacement procedures are now performed each year in the U.S., a number that is expected to increase in coming years due to an aging and active baby boomer population and a growing demand for improved mobility and quality of life. Fortunately, for those seeking a hip replacement, the procedure has become rather routine. In fact, almost every orthopedic surgeon learns the procedure during their residency as a core competency. And while hip replacement
surgery has changed modestly since it was first performed—it still involves removing a damaged joint and replacing it with a prosthesis—the approach to the surgery, or how the surgeon accesses the surgical site, has evolved. Of particular note is the direct anterior approach, which Dr. Robert Judet originally described in France in the 1940s and which was more recently championed by Dr. Joel Matta and a few others in the 1990s. The following is a brief comparison of the traditional posterior hip replacement approach and the relatively newer direct anterior approach and considerations related to this newer approach.
Posterior hip replacement The posterior approach is taught in the vast majority of orthopedic surgical residencies, and it is the most common total hip replacement approach performed today. It is a very utilitarian approach because it can be extended or modified for almost any hip deformity encountered. With the posterior approach, the patient is positioned on their side, and the surgeon accesses the hip joint through an incision in the patient’s buttocks. This approach requires the surgeon to split the gluteus maximus muscle at the back of the hip and to detach the deep short external rotators off of the femur. Most surgeons feel that these rotator tendons help prevent hip dislocation, along with the posterior capsule. Some of the more common post-surgery complications and concerns with the posterior approach are leg length discrepancy, dislocation of the joint, long recovery times, and activity restrictions. Leg length discrepancies are due in part to the side-lying position of the patient, which makes it difficult to accurately measure leg length, as only one leg is visible (the other is under the surgical drape). Instability, or hip dislocation, can occur as a result of the muscles and tendons that help provide hip stability being cut and then reattached during surgery. This can also occur if the implants are not placed in the correct alignment, and most may argue that component positioning is probably the most important factor in stability. Surgical trauma to the posterior soft tissues may require your surgeon to impose an array of post-surgery activity restrictions, particularly limiting hip flexion to no more than 90 degrees and no crossing legs while the hip heals, which impacts daily activities such as sitting in a chair or getting into and out of a car, and can lead to longer recovery times.
Direct anterior hip replacement This approach is truly minimally invasive, meaning the surgeon uses a true internervous plane and intermuscular plane. The direct anterior approach can present some difficulties if the surgeon is not specifically trained in working with the anatomy in the front of the hip. Careful technique is needed to protect major nerves and vessels in this area. Finesse with the soft tissues around the hip is also needed to gain the proper exposure to the acetabulum and the femur in order to properly instrument and correctly place the implants. If a surgeon is accustomed to performing posterior approach hip replacements, he or she will feel “unfamiliar” when looking at those same structures from the opposite side as they do, indeed, look very different from the front than they do from the back. Obtaining proper
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exposure, particularly for the femur, may require some sort of hyperextension of the hip. Although specialized surgical tables are made just for this, it is not an absolute necessity. A typical surgical table that can bend (most do) should suffice. At present, the direct anterior approach is not commonly taught in orthopedic surgical residencies, and surgeons must seek out a mentor, attend specific courses, or enter into a fellowship to gain the required training and skill. As a result, very few orthopedic surgeons in the U.S. routinely perform the direct anterior approach, although interest from patients and surgeons is growing. Through the direct anterior approach, the patient lies on their back, and the surgeon accesses the hip joint through an incision in the front of the patient’s hip starting a few inches below the top of the pelvic bone. This position gives excellent access to the anesthesia team during the procedure. The surgeon then uses a modification of the Hueter approach to access the joint through a natural interval between muscles and nerves, a method that eliminates having to cut or detach important tendons that help provide joint stability.
As various aspects of hip replacement continue to evolve and improve— anesthetics, pain protocols, physical therapy pathways, implant designs, and surgical approaches—orthopedic surgeons are learning that there really isn’t one magic bullet for a perfect outcome. But the direct anterior approach to hip replacement can be a useful piece of the equation to help give patients back their function and independence from hip arthritis. Daren Wickum, MD, is a board-certified orthopedic surgeon with Summit Orthopedics specializing in total joint replacement. He routinely performs the direct anterior approach to hip replacement. He is a member of the American Academy of Orthopaedic Surgeons and the Minnesota Orthopaedic Society.
The direct anterior approach addresses some of the more common post-surgery complications and concerns associated with other approaches. Because the patient is on their back and both legs are draped into the surgical field, the surgeon can easily measure and compare both legs and minimize leg length discrepancies. This natural position of the patient also makes it easier for the surgeon to better determine proper version, or position of the implants, comparing it to a true horizontal plane. The surgeon can also use X-ray, or fluoroscopy, much easier in this position if
Between 2000 and 2009, the number of total hip replacement surgeries in the U.S. increased 73 percent.
needed. Because muscle and tendon insertions to the femur are preserved and their strength maintained, joint stability remains intact, eliminating one of the causes of post-surgery joint dislocation. Because muscle and tendon trauma is minimized, post-surgery activity restrictions are greatly reduced—the patient can sit, cross their legs, walk up and down stairs, and bend down immediately following surgery, and recovery times are reduced as well, with most patients generally walking independently in about two to three weeks’ time.
When to consider the anterior approach Both the posterior and direct anterior approach surgeries use the same primary hip implants, both surgeries take about the same time to perform, and both approaches have shown similar outcomes at about one year post surgery. So why would a surgeon become skilled in the anterior approach? The immediate postoperative recovery seems to be a bit quicker using the direct anterior approach. It also eliminates the need for routine hip precautions after surgery, allowing patients to return to a more normal routine earlier than before. MINNESOTA PHYSICIAN JULY 2017
Beating heart in a box Expanding the transplant donor pool BY KENNETH LIAO, MD, PHD
eart disease is the second-leading cause of death in the state of Minnesota. According to the Minnesota Department of Health, more than 7,500 Minnesotans died from heart disease in 2014. In many cases, the only long-term solution for a failing heart is heart transplantation. But all too often there aren’t enough donor hearts to fill the need, leaving many to die on the waiting list. In 2016, the University of Minnesota Heart Transplant Program added an innovative technology called the Organ Care System (The OCS HEART), more commonly known as “beating heart in a box.” This technology in its armamentarium expands the transplant donor pool, and better screens and supports donor hearts. As a result, more donor hearts became available for heart transplant recipients. This new technology has also pushed us to become more aggressive in selecting donor hearts. At first glance, a donor heart can seem unsuitable, but further investigation can reveal that it is actually fine to use. For example, a fatal trauma such as a suicide, car accident, or drug overdose may leave the heart stunned, but in fact healthy and suitable for transplant.
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The University of Minnesota saw a spike in heart transplant numbers in 2016 thanks in part to this new technology. A total of 32 heart transplants were performed in 2016, compared to the yearly average of 24 in the previous five years. Twenty-nine of those were adults, and three were pediatric patients. The University of Minnesota is one of eight centers across the county currently participating in a trial for the OCS HEART. Through our participation, we’ve learned a lot, including several minor adjustments and revisions that are being made to perfusion flow and pressure. However, the trial is still ongoing and in the early stages, so we still have a lot to learn.
How the technology works The beating heart in a box technology at the University of Minnesota is a first-of-its-kind. Developed by TransMedics, it’s the first portable, warm blood perfusion system that makes a new type of organ transplant, called a living organ transplant, possible. The OCS HEART is no bigger than a portable, college dorm refrigerator (see Figure 1). The machine is portable so can be immediately flown to the hospital when the donor heart that meets the trial criteria becomes available. It takes about 30 minutes from the time the donor heart is retrieved from the
For decades, donor hearts have been—and still are—carefully stored in a cooler and transported on ice. However, this method does not allow for continual blood flow, which increases the chances of damaging the heart. Without the necessary blood flow, the viable organ deteriorates and after a certain amount of time, it becomes unusable. About seven hearts from every 10 donors goes unused because of the inadequacy of the traditional method to preserve certain hearts or because of the great distance the hearts have to travel. Traditionally, donor hearts could only travel up to four to six hours. We know with the OCS HEART that travel time can safely increase. This trial will help us push the extent of those travel limits even further.
Figure 1. The Organ Care System (The OCS HEART), commonly known as “beating heart in a box” technology, is the first of its kind at the University of Minnesota. Photos courtesy of Kenneth Liao, MD, PhD, University of Minnesota Health.
This new technology is able to simulate the conditions of the human body and allows the organ to function as it normally does. Using donor blood, the beating heart technology maintains oxygen levels in the blood and replenishes depleted nutrients in the blood. It also warms the organ as necessary, maintains humidity, protects it from contamination, and enables full functional, biochemical, and metabolic assessment of the organ.
body to hook it up to the machine and restart it. The machine has a pump that is electrically powered. It adjusts the temperature, and keeps the heart in a warm, moist environment while circulating blood, and delivering oxygen and substrates. It also provides constant hemodynamic and metabolic information that allows physicians to monitor and assess the heart.
This continual pumping, temperature, and humidity control allows the organ to be shipped over longer distances, which is a primary limitation to the traditional heart-on-ice method. In addition, the pumping heart gives surgical teams more time to resuscitate the organ in the operating room, which helps increase the odds of a successful transplant.
This beating heart in a box system allows transplant surgeons to potentially use organs that the existing preservation method would not; allowing us to take a second look at hearts we would have traditionally rejected. One of the ways it does this is by eliminating some of the difficulties found in the current method of heart preservation: cold storage.
The beating heart technology follows a similar advancement implemented at the university in 2013—the breathing lung machine. Since implementing this technology, university lung transplant patients who received their Beating heart in a box to page 344
MINNESOTA PHYSICIAN JULY 2017
3Beating heart in a box from page 33
Barriers Right now, some of the biggest barriers to the donor heart pool are population and distance. Specifically, in Minnesota, because of the state’s Midwest location, there is a significantly smaller donor heart pool, especially compared to a state located on the coast. Donor organs are only viable for a limited time once outside the body. Often in Minnesota, we find situations where potential donors may be far away from the recipient’s hospital, and therefore transplant centers struggle to get a This new technology is able to donor heart to the recipient within a short amount simulate the conditions of the of time. But, beating heart technology allows for human body and allows the organ potential donor hearts from further distances to to function as it normally does. travel, allowing University of Minnesota health care teams to bring in hearts from other states if needed.
organs via the breathing lung device have recovered faster than lungs that were transported via traditional on-ice methods. Our hope is that we’re able to achieve similar results for heart transplantation.
The EXPAND Heart Trial
The OCS HEART is commercially available in Europe and Australia and is in clinical use in leading centers. The system is not available for commercial use in the U.S., but is under clinical investigation here. The University of Minnesota is one of eight leading medical centers in the U.S. participating in the EXPAND Heart Trial. The EXPAND Heart Trial (International Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System [OCS] Heart for Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation) evaluates the safety and effectiveness of the OCS HEART for donor hearts that today may not be transplanted due to the limitations of the current cold storage technique. University of Minnesota heart transplant surgeons used OCS HEART on four potential donor hearts in 2016. Two of the donor hearts were considered healthy enough for transplant when they arrived. While this seems like a modest gain, all four would have previously been considered unsuitable for transplant using the older method of transportation. I am confident that this number will continue to increase in the years ahead as we hone best practices using the beating heart technology.
Sioux Falls VA HEALTH CARE SYSTEM
Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package. The VAHCS is currently recruiting for the following healthcare positions: Cardiologist
Apply online at www.USAJOBS.gov
(605) 333-6852 www.siouxfalls.va.gov 34
JULY 2017 MINNESOTA PHYSICIAN
Conclusion We have made significant steps over this past year. In the beginning, we were slightly more cautious. Now we are more familiar with the OCS HEART. It allows us to more aggressively assess donors. As we continue to become more accustomed to this technology and gain more experience with it, we will be able to employ it even more broadly. It will only increase the number of patients we can help. This is a huge gain for the transplant community. Kenneth Liao, MD, PhD, is a cardiothoracic surgeon and surgical director of the University of Minnesota’s heart transplant program. He is principal investigator in the University’s portion of the EXPAND Heart Pivotal Trial, and ranked among the top 1 percent of U.S. cardiac surgeons according to U.S. News and World Report.
Ely Bloomenson Community Hospital is
SEEKING TO EXPAND OUR SURGICAL AND SPECIALTY SERVICES! • WE will work around your schedule and practice! • WE will accommodate your calendar with as little as one surgery day per month! • WE have two surgery suites, modern equipment and trained staff to assist you! • WE are an independent, critical access, community owned hospital with flexibility in working with other health systems! • WE want to work with YOU!
Practice Details • 21 Bed Critical Access Hospital / Level 4 Trauma Center
WE PRACTICE WHOLE LIFE CARE We get to know our patients, how their personal lives and social dynamics affect their health. We create individualized care plans and long-term, trusting relationships that are the key to Whole Life Care. We are currently seeking new physician associates in the areas of:
We are an independent, physician-owned and operated primary care clinic with three NW Minneapolis suburb locations. Our physicians enjoy great autonomy and are involved with all aspects of the business. There are no referral networks, you will always have the freedom to offer your patients real choices. Northwest Family strives to give our physicians and staff an appropriate work life balance. We offer competitive salary and benefits. Please contact us for more details.
www.northwestfamilyclinics.com Please contact or email CV: Erin Precup, HR 763-504-6523, email@example.com 5700 Bottineau Blvd., Crystal, MN 55429
• 3,000 ER patients seen annually • Lab and Diagnostic Imaging readily available • Nearest Level 2 Trauma Center – 120 miles away • 7 ER rooms Ely Bloomenson Community Hospital borders the vast acreage of the Boundary Waters Canoe Area Wilderness providing recreation opportunities including fishing, camping, and canoeing just to name a few. Ely, itself, surrounded by 35 lakes provides outstanding family amenities including a community focus on education (Pre-K - 12 and Vermilion Community College) offering excellent courses of study. Performing arts, festivals, concerts, parks, beaches and a golf course provide a quality of life in Ely that other people across the country only dream about!
We welcome all interested Surgeons or Specialty Service Providers to contact Patti Banks at
218.365.8765 or firstname.lastname@example.org
MINNESOTA PHYSICIAN JULY 2017
3The 2017 legislative wrap-up from page 19 Legislature moved quickly to pass a budget and allow for what they thought was sufficient time to negotiate a final agreement with the Governor. Around $1.3 million remained on the surplus following the early spending on the premium relief package and reinsurance program. There was little question that the Legislature was going to move a significant tax bill forward along with a transportation funding package, but the remainder of the budget was largely up in the air. The Health and Human Services budget was the target of significant spending reductions by not only the House and Senate but the Governor as well. In late February, the Governor proposed almost $400 million in reductions to general fund health care spending, but then offset those cost reductions through a $700 million dollar transfer from the Health Care Access Fund. More important, the Governor proposed to eliminate the current sunset on the provider tax at the end of 2019. Fast forward to early May and both the House and Senate proposed significant cuts to Health and Human Services spending—$500 million and $300 million respectively—but specifically left the Health Care Access Fund untouched and kept the provider tax repeal in place. The Legislature and the Governor found themselves at a standstill up until the last moments of the session when the Governor and legislative leaders announced a tentative deal on the framework of a budget agreement that would need to be solved in a short special session. However, the framework in fact turned out to be little more than a faint chalk outline
JULY 2017 MINNESOTA PHYSICIAN
requiring legislative leaders and the Governor to continue their back-andforth negotiations around the clock for almost three full days before the special session concluded in the very early hours of the morning on May 26. The final Health and Human Services budget agreement largely left providers untouched and did not include any of the cuts from the original Senate bill to both hospitals and physicians. But the foundation of the agreement relied on an almost $400 million transfer from the Health Care Access Fund in the current biennium and an additional $300 million transfer in 2020 and 2021 to pay for Medical Assistance costs in the general fund, leaving the Health Care Access Fund almost completely drained by 2021. The other major reductions in the bill came through a one-month payment delay for the state’s managed care plans. The combination of the proposed drastic changes to Medicaid funding being discussed at the federal level along with some significant budget issues facing the Health and Human Services budget in 2020 and 2021—including the loss of revenue from the provider tax—is setting up for an extremely difficult session in only a few short years that will likely drastically change how health care is paid for in Minnesota for years to come.
Nate Mussell, JD, is with the Minnesota law firm of Lockridge Grindal Nauen, PLLP. The firm provides legal and governmental relations services to a variety of health care providers.
St. Health Cloud VA Care System Brainerd | Montevideo | Alexandria
Opportunities for full-time and part-time staff are available in the following positions: • Internal Medicine/Family Practice • Physician (Extended Care & Rehabilitation) • Physician (Geriatric Evaluation & Management) • Physician (Hospice & Palliative Care) • Physician (Pain Clinic/Outpatient Primary Care) • Psychiatrist • Urologist
Applicants must be BC/BE.
US Citizenship required or candidates must have proper authorization to work in the U.S. Physician applicants should be BC/BE. Education Debt Reduction Program funding may be authorized for the health professional education that was required of the position. Possible recruitment bonus. EEO Employer. Competitive salary and benefits with recruitment/ relocation incentive and performance pay possible.
For more information:
Visit www.USAJobs.gov or contact Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303
(320) 255-6301 MINNESOTA PHYSICIAN JULY 2017
3Neonatal abstinence syndrome from page 17 disorder may decrease NAS severity, and can ensure that opioid use during pregnancy is safe and medically managed. MAT can also give mothers the opportunity to develop healthy habits and parenting skills that will ensure their infants have safe and thriving home environments. Access to contraception Another important pathway to reduce NAS is access to contraception. Nearly 50 percent of pregnancies in the U.S. are unintended. In rural areas, rates of unintended pregnancies are even higher. Thus, some women with an opioid use disorder may find themselves pregnant unintentionally. Screening for unintended pregnancy risk, inquiring about family planning goals, and providing a preference-sensitive method of contraception are critical services physicians can offer women of reproductive age, particularly those with an opioid use disorder. Because of the risks of opioid use disorders during pregnancy, preventing unintended pregnancies among women who are dependent on opioids is imperative. Long-acting reversible contraceptives, including hormonal implants and intrauterine devices, are safe and more effective than alternative methods like contraceptive pills, rings, patches, condoms, and diaphragms. Physicians seeking to reduce the effect of the opioid crisis on infants may consider quality improvement programs to improve access to these services in their clinics.
Physicians, in partnership with local county health departments and other community organizations, should aggressively treat these disorders with multi-disciplinary, non-opioid based approaches, including cognitive behavioral therapy, psychotherapeutics, exercise/physical therapy, and treatment of co-occurring substance use disorders. Although rates of NAS continue to rise, rural physicians can curb the long-term effects of the opioid crisis on both individual families and their communities. It may not be easy, and it will certainly take the effort of a dedicated team, but we believe it will be worth it.
Nicole Villapiano, MD, MSc, is a primary care physician and a former Rural Physician Associate Program (RPAP) participant at the University of Minnesota. She currently works for Family Health Network, a rural community health center in the Finger Lakes region of central New York.
Tyler N.A. Winkelman, MD, MSc, is a primary care physician and health policy researcher at Hennepin County Medical Center in Minneapolis. He recently completed a Robert Wood Johnson Foundation Clinical Scholars
Preventing addiction before it starts
fellowship at the University of Michigan. His research focuses on the effects of
Finally, physicians can prevent opioid use before it starts. Untreated mental health and chronic pain disorders contribute to opioid use disorders.
JULY 2017 MINNESOTA PHYSICIAN
health insurance and medical care for justice-involved individuals and other
I CAN DO ADVENTURE The approaching holiday season is about hope, magic and miracles. So too, is Diveheart. The Downers Grove-based not for profit organization provides hope, magic, and even miracles, to individuals with disabilities. Diveheart offers children, veterans and others with disabilities the opportunity to escape gravity through Scuba Therapy. Diveheart participants include individuals with virtually any type of disability including Down syndrome, autism, cerebral palsy, paraplegia, blindness, deafness, spinal cord injuries, traumatic brain injury, post-traumatic stress disorder and more.
HOPE The Diveheart vision is to unleash the unrealized human potential that often exists in individuals with disabilities. The confidence, independence and self-esteem realized by Diveheart participants is tremendous. Diveheart helps individuals focus on what they can do, rather than what they can’t do. MAGIC Diveheart Scuba Therapy helps participants focus on their abilities, rather than their disabilities. This helps them to take on challenges that they may never have taken on before. Furthermore the forgiving, weightless environment of underwater offers buoyancy and balance to individuals who might struggle on land. They’re often able to move in ways that are impossible before joining a Diveheart program. Zero gravity is the great equalizer. MIRACLES Diveheart participants have experienced improved range of motion, ability to focus, pain relief and more. The aspect of pressure while diving provides benefits for people with autism and chronic pain due to spinal cord injuries. Some tell us that after diving, they’re pain free for up to three weeks, often for the first time since their injury. Every one is able to help perpetuate hope, magic and miracles during the holiday season. Your donation helps to make it possible for individuals with disabilities to experience Scuba Therapy, and the resulting benefits so that they might “Imagine the Possibilities” in their lives. Please visit www.diveheart.org/donate/ to learn more about how you can help promote the hope, magic and miracles of Diveheart. Diveheart donations are also accepted at 900 Ogden Ave #274 Downers Grove, Illinois 60515. Jim Elliott Founder & President Diveheart
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www.coverys.com www.coverys.com NOVEMBER 2015