MN Physician August 2016 by Minnesota Physician Publishing

Vo l u m e X X X , N o . 5 A u g u s t 2 016

Generic antiepileptic drug substitution

MMXVI

Safety confirmed by new studies By Stephanie Roller, MD, and Michael Privitera, MD

100 Influential Minnesota Health Care Leaders Recognizing excellence

e are pleased to present this special feature recognizing 100 leaders who help make health care in Minnesota a global model of excellence. Once every four years we invite our readers to submit the names of colleagues whose outstanding leadership can be acknowledged in these pages. We thank all those who participated in the nomination process and those who helped with the submissions.

Influence and leadership can take many forms—sometimes the most influential leaders can be found in the least aspiring places (Mother Theresa on the streets of Calcutta). Sometimes leadership is provided by those who are least visible. In some ways, the nature of providing health care at any level is an inherent act of leadership. The individuals presented here represent a

cross section of the breadth and depth of Minnesota’s health-care delivery system, from clinical care to health care policy to administration and management. Modifiers such as “most,” “best,” “top,” etc., do not apply to this list. Though the health care industry is constantly evolving, the ongoing implementation of the Affordable Care Act (ACA) over the past four years has brought perhaps the most dramatic changes since 1965 when President Johnson enacted Medicare. Many of the responses that follow reflect both the promise and challenges created by the ACA. We wish this group of health care professionals the best in leading the state through the exciting and challenging times that lie ahead. 100 Influential MN Health Care Leaders to page 16

pproximately 2.2 million people in the United States have epilepsy (Institute of Medicine report, 2012) and it is estimated that the U.S. health care system spends more than $15.5 billion on epilepsy care annually. Use of generic medications among all therapeutic areas has been quoted to save patients $8 to 10 billion annually (according to the Congressional Budget Office). Widespread use of generic drugs has the potential to improve health care costs for both national and personal economy in the epilepsy community. Lower medication costs may lead to improved medication adherence resulting in improved seizure control. The difference between brand and generic products can be shocking: the cost of a 30-day supply of lamotrigine can decrease from $814 for the brand to $5 for the generic (Red Book Online). Generic antiepileptic drug substitution to page 46

Rapid Response | Critical Care Life Link III is a great Midwest model of nine hospital systems cooperatively delivering the goals of the Triple Aim. These hospital systems are member-owners of Life Link III:

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AUGUST 2016 • VOLUME XXX, NUMBER 5

MINNESOTA HEALTH CARE ROUNDTABLE COVER FEATURES

100 Influential Minnesota Health Care Leaders

FORTY-SIXTH SESSION

Value - Based Reimbursement:

A new way to pay for health care

Recognizing excellence By MPP Staff

Generic antiepileptic drug substitution Safety confirmed by new studies

Thursday, November 3, 2016 • 1:00-4:00 PM

By Stephanie Roller, MD, and Michael Privitera, MD

The Gallery (lobby level), Downtown Minneapolis Hilton and Towers

DEPARTMENTS CAPSULES 10 MEDICUS

INTERVIEW

Of the people, by the people, for the people Walter F. Mondale

RISK MANAGEMENT

Terminating the provider/ patient relationship By Ginny Adams, RN, BSN, MPH, CPHRM

PROFESSIONAL UPDATE: ONCOLOGY 42 Improving outcomes for colorectal cancer By M.P. Spencer, MD, FACS, FASCRS

Background and Focus: As initiatives driven by federal health care reform move forward, the term “Value-Based Purchasing” (VBP) is being applied to a wide spectrum of issues. But what does this mean? CMS is developing measurements, well over 150 to date, to define what “value” means in health care. It is proposed that these metrics will be used to create incentives that pay more for better care in every element of health care delivery. Hospitals, physician practices, home care, and long-term care will all be reimbursed by an emerging new math. Objectives: We will explore the motivations behind this changing approach to purchasing health care. We will examine what is being measured and what value really means. We will discuss the arguments that claim VBP is a bad idea and those that believe it is the best solution. We will discuss how a collaborative, transparent system, that integrates care teams, health information technology and improved reimbursement methods will help achieve increased access to high-quality, cost-effective care for patients. Panelists include: • Don Flott, Director of Utilization and Integration Services, Mayo Medical Laboratories • Allison LaValley, Executive Director, athenahealth • David Melloh, JD, Chair, Health Law Practice Group at Lindquist & Vennum LLP • Ross D’Emanuele, JD, Co-Chair, Health Care Industry Group at Dorsey & Whitney LLP Sponsors include: • athenahealth • Lindquist & Vennum LLP • Mayo Medical Laboratories • Dorsey & Whitney LLP • Coverys

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AUGUST 2016 MINNESOTA PHYSICIAN

MINNESOTA PHYSICIAN AUGUST 2016

It clicked when my doctor and I discussed Trulicity ÂŽ1,2

Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy that offers unbeaten A1C reduction* in 6 head-to-head trials, once-weekly dosing, and the Trulicity pen.1,3 If you have patients who struggle with the idea of adding an injectable, consider Trulicity as an option for the next step in their care.1,4 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction. *In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3

For more information on 6 head-to-head trials, see the following page.

Trulicity is a GLP-1 RA that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.

Select Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on inside spread and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.

Learn about unbeaten A1C reduction at Trulicity.com

AUGUST 2016 MINNESOTA PHYSICIAN

Mean A1C change from ba

-0.6

-0.8 -1.0 -1.2

-0.8

-1.1 * Unbeaten A1C reduction across 6 head-to-head trials -1.4

-1.6

Lantus® (100 mg) (n=262; Baseline A1C: 8.1%)

Trulicity® (0.75 mg) (n=272; Baseline A1C: 8.1%)

Trulicity® (1.5 mg) (n=273; Baseline A1C:1,3 8.2%)

Data represent least-squares mean ± standard error.

*In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction.

A1C reduction from baseline

MeanA1C A1Cchange change from from baseline Mean baseline(%) (%)

0.0

Add-on to metformin (26 weeks)

Add-on to metformin (52 weeks)

Add-on to metformin and Actos® (26 weeks)

Add-on to metformin and Amaryl® (52 weeks)

Compared to Victoza®3

Compared to Januvia®1,5,6

Compared to Byetta®1,7

Compared to Lantus®1,8-10

-0.2 -0.4

-0.39

-0.6

-0.46

-0.63

-0.8 -1.0

-0.87

-1.2

-0.99

-1.10

-1.4

-1.51

-1.8 Victoza (1.8 mg) (n=300; Baseline A1C: 8.1%)

Januvia (100 mg) (n=273; Baseline A1C: 8.0%)

Placebo (n=141; Baseline A1C: 8.1%)

Lantus (n=262; Baseline A1C: 8.1%)

Trulicity® (1.5 mg) (n=299; Baseline A1C: 8.1%)

Trulicity® (0.75 mg) (n=281; Baseline A1C: 8.2%)

Byetta (10 mcg BID) (n=276; Baseline A1C: 8.1%)

Trulicity (0.75 mg) (n=272; Baseline A1C: 8.1%)

Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)

Trulicity (0.75 mg) (n=280; Baseline A1C: 8.1%)

Trulicity (1.5 mg) (n=273; Baseline A1C: 8.2%)

Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)

Data represent least-squares mean ± standard error.

•

26-week, randomized, open-label comparator phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day

•

104-week, randomized, placebocontrolled, double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day

•

Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline at 26 weeks (-1.42% vs -1.36%, respectively; difference of -0.06%; 95% CI [-0.19, 0.07]; 2-sided alpha level of 0.05 for noninferiority margin 0.4%; mixed model repeated measures analysis)

•

Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.25% margin; analysis of covariance using last observation carried forward [LOCF]); primary objective met

•

-1.08

-1.30

-1.36 -1.42

-1.6

-0.76

Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met

•

Key secondary objectives of superiority of both dulaglutide doses vs Januvia were met

Superiority was only demonstrated in the studies versus Byetta and Januvia.

Additional study results Although this was a monotherapy study, Trulicity is not recommended as a first-line therapy. In a 52-week randomized, double-blind phase 3 study, adult patients with type 2 diabetes were treated with monotherapy. Baseline A1C=7.6% for each of metformin (n=268), Trulicity 0.75 mg (n=270), and Trulicity 1.5 mg (n=269). At the 26-week primary endpoint, mean A1C reductions were metformin: 0.6%; Trulicity 0.75 mg: 0.7%; Trulicity 1.5 mg: 0.8%. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs metformin on A1C change from baseline at 26 weeks (-0.8% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met.1,11

78-week, randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Amaryl (≥4 mg/day)

•

52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos (up to 45 mg/day)

•

Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided alpha level of 0.025; analysis of covariance using LOCF); primary objective met

• Starting dose of Lantus was 10 units daily.

Key secondary objectives of superiority of both dulaglutide doses vs Byetta were met

•

Lantus titration was based on self-measured fasting plasma glucose utilizing an algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint. Mean daily dose of insulin glargine was 29 units at the primary endpoint Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 52 weeks (-1.1% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met

In a 52-week randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients, Trulicity was studied in combination with Humalog® with or without metformin ≥1500 mg/day. Humalog was titrated based on preprandial and bedtime glucose, and Lantus was titrated based on fasting glucose; 36% of patients randomized to glargine were titrated to the fasting glucose goal at the 26-week time point. Baseline A1C=8.5% for Lantus (n=296), baseline A1C=8.4% for Trulicity 0.75 mg (n=293), and baseline A1C=8.5% for Trulicity 1.5 mg (n=295). At the 26-week primary endpoint, mean A1C reductions were Lantus: 1.4%; Trulicity 0.75 mg: 1.6%; Trulicity 1.5 mg: 1.6%. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 26 weeks (-1.6% vs -1.4%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met.1,12,13

Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on the following page and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.

MINNESOTA PHYSICIAN AUGUST 2016

Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS

In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%). Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree. Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential beneﬁt outweighs potential risk to fetus. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insufﬁcient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated. Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is conﬁrmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. Hypersensitivity Reactions: Systemic reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.

Please see Brief Summary of Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages. Please see Instructions for Use included with the pen. DG HCP ISI 20APR2015 Trulicity® and Humalog® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Actos® is a registered trademark of Takeda Pharmaceutical Company Limited. Byetta® is a registered trademark of the AstraZeneca group of companies. Amaryl® and Lantus® are registered trademarks of Sanofi-Aventis. Januvia® is a registered trademark of Merck & Co., Inc. Victoza® is a registered trademark of Novo Nordisk A/S. Other product/company names mentioned herein are the trademarks of their respective owners. References 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. 2. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014. 3. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384:1349-1357. 4. Polonsky WH, Hajos TR, Dain MP, Snoek FJ. Are patients with type 2 diabetes reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population. Curr Med Res Opin. 2011;27(6):1169-74. doi: 10.1185/03007995.2011.573623. Epub Apr 6, 2011. 5. Data on file, Lilly USA, LLC. TRU20150203A. 6. Data on file, Lilly USA, LLC. TRU20150203B. 7. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) [published correction appears in Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37:2159-2167. 8. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2) [published online ahead of print June 18, 2015]. Diabetes Care. doi:10.2337/dc14-1625. 9. Data on file, Lilly USA, LLC. TRU20140912A. 10. Data on file, Lilly USA, LLC. TRU20150313A. 11. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37:2168-2176. 12. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385:2057-2066. 13. Data on file, Lilly USA, LLC. TRU20150313B.

The most common adverse reactions reported in ≥5% of Trulicitytreated patients in placebo-controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%),

PP-DG-US-0393

01/2016

AUGUST 2016 MINNESOTA PHYSICIAN

TrulicityTM (dulaglutide) Brief Summary: Consult the package insert for complete prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS • In male and female rats, dulaglutide causes a dose-related and treatmentduration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. • Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting. Hypersensitivity Reactions: Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. If a hypersensitivity reaction occurs, the patient should discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal failure, use caution when initiating or escalating doses of Trulicity in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. ADVERSE REACTIONS

INDICATIONS AND USAGE Trulicity™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Risk of Thyroid C-cell Tumors: In male and female rats, dulaglutide causes a doserelated and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether Trulicity will cause thyroid C-cell tumors, including MTC, in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. One case of MTC was reported in a patient treated with Trulicity. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of Trulicity and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. Pancreatitis: In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis-related adverse reactions were reported in patients exposed to Trulicity versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analysis of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to Trulicity (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years). After initiation of Trulicity, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue Trulicity. If pancreatitis is confirmed, Trulicity should not be restarted. Trulicity has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: The risk of hypoglycemia is increased when Trulicity is used in combination with

Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Pool of Placebo-controlled Trials: These data reflect exposure of 1670 patients to Trulicity and a mean duration of exposure to Trulicity of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Trulicity-Treated Patients: Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5 mg (N=834) (listed as placebo, 0.75 mg, 1.5 mg): nausea (5.3%, 12.4%, 21.1%), diarrheaa (6.7%, 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%, 4.2%, 5.6%). (a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.) Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.75 mg and 1.5 mg of Trulicity as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively. In addition to the adverse reactions ≥5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%; 3.9%; 3.7%), flatulence (1.4%; 1.4%; 3.4%), abdominal distension (0.7%; 2.9%; 2.3%), gastroesophageal reflux disease (0.5%; 1.7%; 2.0%), and eructation (0.2%; 0.6%; 1.6%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of Trulicity as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3342 patients with type 2 diabetes were treated with Trulicity for a mean duration 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as ≥5% above. Other Adverse Reactions: Hypoglycemia: Incidence (%) of Documented Symptomatic (≤70 mg/dL Glucose Threshold) and Severe Hypoglycemia in Placebo-Controlled Trials: Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), Trulicity 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5 mg: 5.0%; Severe: all 0. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. Documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg

TrulicityTM (dulaglutide)

Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease. The concurrent use of Trulicity and basal insulin has not been studied. CONTRAINDICATIONS Do not use in patients with a personal or family history of MTC or in patients with MEN 2. Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components. WARNINGS AND PRECAUTIONS

Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75

MINNESOTA PHYSICIAN AUGUST 2016

DG HCP BS 20APR2015

PRINTER VERSION 1 OF 2

and 1.5 mg, respectively, was co-administered with prandial insulin. Severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg, and 1.5 mg, respectively, was co-administered with prandial insulin. Heart Rate Increase and Tachycardia Related Adverse Reactions: Trulicity 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm). The long-term clinical effects of the increase in HR have not been established. Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to Trulicity. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4%, and 1.6% of patients treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3%, and 2.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Immunogenicity : Across four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) Trulicitytreated patients developed anti-drug antibodies (ADAs) to the active ingredient in Trulicity (ie, dulaglutide). Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies against native GLP-1. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products. Hypersensitivity : Systemic hypersensitivity adverse reactions sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and Phase 3 studies. Injection-site Reactions: In the placebo-controlled studies, injection-site reactions (eg, injection-site rash, erythema) were reported in 0.5% of Trulicity-treated patients and in 0.0% of placebo-treated patients. PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) Block: A mean increase from baseline in PR interval of 2-3 milliseconds was observed in Trulicity-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with Trulicity than placebo (0.9%, 1.7%, and 2.3% for placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5%, and 3.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Amylase and Lipase Increase: Patients exposed to Trulicity had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebotreated patients had mean increases of up to 3%. DRUG INTERACTIONS Trulicity slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to any clinically relevant degree. USE IN SPECIFIC POPULATIONS Pregnancy - Pregnancy Category C: There are no adequate and well-controlled studies of Trulicity in pregnant women. The risk of birth defects, loss, or other adverse outcomes is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes to maintain good metabolic control before conception and throughout pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats and rabbits, dulaglutide administered during the major period of organogenesis produced fetal growth reductions and/or skeletal anomalies and ossification deficits in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for clinical adverse reactions from Trulicity in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years. Geriatric Use: In the pool of placebo- and active-controlled trials, 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. Renal Impairment: In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicitytreated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2). TrulicityTM (dulaglutide)

Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75

DG HCP BS 20APR2015

No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed. There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored. Gastroparesis: Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with pre-existing gastroparesis. OVERDOSAGE Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (eg, nausea, vomiting) and nonsevere hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms. PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide • Inform patients that Trulicity causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician. • Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Trulicity promptly, and to contact their physician, if persistent severe abdominal pain occurs. • The risk of hypoglycemia may be increased when Trulicity is used in combination with a medicine that can cause hypoglycemia, such as a sulfonylurea or insulin. Review and reinforce instructions for hypoglycemia management when initiating Trulicity therapy, particularly when concomitantly administered with a sulfonylurea or insulin. • Patients treated with Trulicity should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with Trulicity of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs. • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, patients must stop taking Trulicity and seek medical advice promptly. • Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant. • Prior to initiation of Trulicity, train patients on proper injection technique to ensure a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inform patients of the potential risks and benefits of Trulicity and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and advise patients to seek medical advice promptly. • Each weekly dose of Trulicity can be administered at any time of day, with or without food. The day of once-weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before. If a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, it should be administered as soon as possible. Thereafter, patients can resume their usual once-weekly dosing schedule. If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, the patient should not administer the missed dose and instead resume Trulicity with the next regularly scheduled dose. • Advise patients treated with Trulicity of the potential risk of gastrointestinal side effects. • Instruct patients to read the Medication Guide and the Instructions for Use before starting Trulicity therapy and review them each time the prescription is refilled. • Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. • Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range. HbA1c is especially useful for evaluating long-term glycemic control.

Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2014, 2015, Eli Lilly and Company. All rights reserved. Additional information can be found at www.trulicity.com DG HCP BS 20APR2015 TrulicityTM (dulaglutide)

DG HCP BS 20APR2015

PRINTER VERSION 2 OF 2 AUGUST 2016 MINNESOTA PHYSICIAN

CAPSULES

Bridges to Excellence Program Recognizes 276 Clinics The Minnesota Bridges to Excellence program is paying almost $1 million to 276 Minnesota and border state clinics as a reward for achieving optimal care measures or improving clinical outcomes for patients with diabetes, vascular disease, and depression. The Minnesota Health Action Group, which administers the program, focuses on these conditions because they impact hundreds of thousands of Minnesotans and are known to be primary drivers of health care costs. “Health care is dynamic and everything—from clinical guidelines to best practices and benefit plan designs—is changing, yet improving health and health care remains a shared priority,” said Carolyn Pare, president and CEO of Minnesota Health Action Group. “Through Minnesota Bridges to Excellence, health care purchasers who work with the Action Group have continued to send a clear message that high value health care and outcomes are a

priority. Meanwhile, clinics across the state continue to meet the challenge of delivering optimal, high value care to their patients.” To receive awards, clinics must have a certain percentage of patients at optimal levels of care or increase their percentage from the previous year. Clinic scores are publicly reported by Minnesota Community Measurement. Of the clinics receiving rewards in 2016, 14 are being recognized for achieving optimal diabetes care, 30 for achieving optimal vascular care, and 70 for achieving optimal depression care based on depression remission at six months. In addition, 89 are being recognized for meeting the improvement goal in optimal diabetes care, 119 for improvement in optimal vascular care, and 39 for improvement in depression remission at six months. Five clinics were recognized for meeting optimal care achievement goals in all three conditions: HealthPartners–Arden Hills; Entira Family Clinics–White Bear Lake-Bellaire; Entira Family Clinics–Shoreview; Park Nicollet– Carlson Parkway; Park Nicollet– Golden Valley.

MINNESOTA PHYSICIAN AUGUST 2016

Agencies Funded to Increase Access to HIV Prevention Drug The Minnesota Department of Health (MDH) has awarded five agencies $400,000 grants to increase access to Pre-Exposure Prophylaxis (PrEP), a drug combination taken daily in pill form that reduces the chances of HIV infection. The grants are part of a comprehensive strategy to reduce new HIV infections in Minnesota. The three-year grants, which began July 1, were awarded to: Hennepin County Public Health– Red Door Care, Prevention and Outreach Services; Minneapolis Medical Research Foundation–Positive Care Clinic; Saint Paul-Ramsey Public Health–Clinic 555; Minnesota AIDS Project; and University of Minnesota–Youth and AIDS Project. The clinics and community organizations will use the funds to provide PrEP programming to reach populations that continue to experience higher rates of HIV infection and in geographical areas that are highly impacted. “PrEP is one of the most effective HIV prevention tools we’ve

had since the HIV epidemic began more than 35 years ago, but stigma and access continue to hamper efforts to get it in the hands of those who need it,” said Darin Rowles, director of prevention and coordinated care at Minnesota AIDS Project. “With this grant we will have the tools to engage the community with factual, science-based information about PrEP, and to help members of the community make the decision of whether PrEP is a good fit for them.”

Mayo to Collaborate with Molecular Diagnostics Company Mayo Clinic Center for Individualized Medicine is partnering with Transplant Genomics Inc. (TGI), a molecular diagnostics company with an initial focus on kidney transplant recipients, to develop, validate, and commercialize diagnostic tests enabling personalized immunosuppression for solid organ transplant recipients. The organizations’ multiyear collaboration includes an

assessment of TGI’s TruGraf test for renal transplant monitoring, a Mayo Clinic investment in TGI, and working together on co-development of new tests and technologies for things such as exploratory studies in heart and liver transplantation. Physicians and researchers from several Mayo Clinic campuses will participate in the partnership, including its Arizona, Florida, and Rochester, Minnesota locations. “At Mayo, our research in this area is focused on improving long-term kidney graft survival, so that patients would lead healthier lives,” said Mark Stegall, MD, surgeon at Mayo Clinic and a principal investigator on the project. “Genomic analysis of blood can reveal early signs of rejection in transplanted kidneys. The potential clinical utility is to be able to monitor for rejection more frequently than is possible with surveillance biopsies and to individualize immunosuppression in transplant recipients.” “TruGraf’s ability to detect early transplant rejection in patients with stable kidney transplantation function will provide physicians with a tool to help provide the appropriate levels of immunosuppression therapy,” said Roy First, MD, chief medical officer of TGI. “Our first collaborative project together is a case study in individualized medicine in which TruGraf will be used to support decisions around personalized immunosuppression.”

Youth Injured in Motor Vehicle Accidents Have Best Outcomes at Level I Pediatric Trauma Centers Children and adolescents who have been injured in motor vehicle accidents have better outcomes when they are treated at a standalone Level I pediatric trauma center than at general adult trauma centers or adult trauma centers with Level I pediatric qualifications, according to a new study from researchers at Children’s Hospitals and Clinics of Minnesota (Children’s Minnesota). “Although children treated at level one trauma centers receive the highest level of care, these data suggest adolescents treated

at freestanding pediatric hospitals have better outcomes following a motor vehicle accident,” said Nathaniel Kreykes, MD, trauma medical director at Children’s Minnesota. “The conservative approach to pediatric trauma protocols may offer an advantage to injured adolescents as they transition from childhood to adulthood.” Researchers analyzed data from the American College of Surgeons National Trauma Data Bank for 28,145 pediatric patients (16,643 children under the age of 15 and 11,502 adolescents between the ages of 15 and 17) treated at Level I trauma centers between 2009 and 2012. Of those, 19.9 percent were treated at a pediatric trauma center, 21.7 percent were treated at an adult trauma center with pediatric qualifications, and 58.4 percent were treated at a general adult trauma center. Most patients had head and neck injuries (66.2 percent) and many had multiple injuries (42.7 percent). They discovered that mortality rates for children treated at a general adult trauma center were similar to those treated at a pediatric trauma center. However, those treated at an adult trauma center faced a greater risk of complications such as pneumonia. Adolescents treated at a general adult trauma center or an adult trauma center with pediatric qualifications had worse mortality rates than those treated at a pediatric trauma center. Overall, children and adolescents were more likely to be treated with invasive injury management procedures at a general adult trauma center or an adult trauma center with pediatric qualifications than at a pediatric trauma center. “Pediatric trauma centers are exclusively focused on the care of injured children. As such, the care teams are often more comfortable recommending a conservative approach, including observation instead of aggressive treatment or diagnosis, compared to physicians at adult trauma centers who treat fewer pediatric patients,” said Anupam B. Kharbanda, MD, chief of critical care services at Children’s Minnesota and an author of the study. “This, combined with very aggressive use of standardized pediatric care pathways in these centers, likely contributes to the better outcomes we noted in this study.” Capsules to page 12

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Minnesota Expands Newborn Screening Program The Minnesota Department of Health (MDH) has announced the addition of three disorders to the list of conditions that all newborns are screened for: mucopolysaccaridosis type 1, Pompe disease, and X-linked adrenoleukodystophy. The disorders were recommended for screening at a national level and by Minnesota’s advisory committee. According to MDH, preliminary data from two states that already screen for these disorders (Missouri and New York) indicate that about five to 15 Minnesota children will benefit from the screening each year. The screenings are expected to begin in January 2017, bringing the total conditions Minnesota newborns are screened for to 60. “By adding these disorders to the newborn screening panel, we will be able to diagnose and begin treating these disorders much earlier, leading to much better outcomes for Minnesota’s

newborns,” said Paul Allwood, MDH assistant commissioner. The disorders are all caused by an inherited genetic mutation and can cause bone abnormalities, muscle weakness, nerve impairment, hearing loss, respiratory failure, and heart failure. Left untreated, the disorders can be fatal.

Seniors Covered by Integrated Program Have Better Health Outcomes A study commissioned by the U.S. Department of Health and Human Services has found that Minnesota seniors served by the Minnesota Senior Health Options (MSHO) program, which combines Medicaid and Medicare benefits, have better health outcomes than those served by Minnesota Senior Care Plus, a Medicaid-only program. “This study affirms the value of what we have been doing in Minnesota for almost two decades,” said Emily Piper, human services commissioner. “We hope that other states can learn from our

experience as they work to better serve low-income seniors.” Researchers looked at three years of data for the MSHO program, which serves about 36,000 older adults eligible for Medicare and Medicaid. They compared outcomes to those for Minnesota Senior Care Plus, which covers about 14,000 seniors. Between 2010 and 2012, seniors served by MSHO were 48 percent less likely to be admitted to a hospital compared to those served by Minnesota Senior Care Plus. For MSHO enrollees who were hospitalized, about 26 percent had fewer hospital stays. MSHO enrollees were 6 percent less likely to visit an outpatient emergency department than those enrolled in Minnesota Senior Care Plus, and those who did visit an emergency room had 36 percent fewer visits. They were also 13 percent more likely to receive homeand community-based long-term care services, 16 percent less likely to have any assisted living services, and 9 percent more likely to have any hospice care use. “Integrated care is improving the lives of some of the most vulnerable Americans,” said a statement

about the study from the Centers for Medicare & Medicaid Services.

HCMC Named Medical Services Provider of U.S. Bank Stadium Hennepin County Medical Center (HCMC) has partnered with the Minnesota Sports Facilities Authority to become the exclusive medical service provider for U.S. Bank Stadium, which opened in July. HCMC paramedics and emergency medical response personnel will provide first aid and other medical care needs for participants and fans at Vikings games and other major events at the stadium. If hospitalization is necessary, patients will be taken to HCMC’s main campus, located a block away from the stadium.

Correction There was an error in “The 2016 Legislative Wrap-up,” by Nate Mussell in the July 2016 issue. It was stated that, “All 210 legislators are up for re-election...” but it should have said “201” legislators.

MANY FACES OF COMMUNITY HEALTH 11TH ANNUAL CONFERENCE

Thursday–Friday, November 3-4, 2016 • Marriott Minneapolis Southwest—Minnetonka, MN Join us for a two-day conference that explores ways to improve care and health equity in under-served populations and among those living in poverty. It brings information and resources on chronic disease prevention and care, public policy and health innovations to Minnesota’s health care community, with a focus on safety net providers. The conference offers two tracks: Management / Policy and Clinical. Continuing Medical Education credits applied for.

Keynote Speaker: Syl Jones Syl Jones, playwright, author and Resident Fellow in Narrative Medicine at Hennepin County Medical Center, will speak on “Chronic Wellness: How to become the hero of your own life story.” Mr. Jones will relate his research and personal experience with diabetes, describing how to work within the health system to change its approach from illness care to wellness care.

For a complete list of speakers and times, visit the conference web site:

manyfacesconference.org

For more information contact Sean Schuette at 952-564-3077 or sschuette@intrinxec.com

MINNESOTA PHYSICIAN AUGUST 2016

MEDICUS Paul Van Gorp, MD, family practice provider at CentraCare Health–Long Prairie, received the Rural Health Lifetime Achievement award from the Minnesota Department of Health, Minnesota Rural Health Association, and Duluth-based National Rural Health Resource Center. The agencies recognized public health workers for their service to the state’s rural Paul Van Gorp, communities and residents at the MinneMD sota Rural Health Conference in Duluth. Van Gorp has served as a preceptor for the Rural Medical Scholars and Rural Physician Associate programs for 40 years and helped develop the Comprehensive Advanced Life Support program, which provides emergency medical training to rural health care teams and U.S. Embassy medical personnel around the world. He also volunteers at Project H.E.A.L. to provide free health screenings and basic care for residents with little or no insurance. Van Gorp earned his medical degree at the University of Minnesota Medical School. In addition, Matthew E. Bernard, MD, cofounder and medical director at The Center Clinic in Dodge Center, received the Rural Health Hero award. The Center Clinic is a volunteer-based, nonprofit clinic that provides teens, children, low-income, uninsured, and underinsured people with physical and mental health care, counseling, and education. Bernard also Matthew E. serves as the chair of the department of family Bernard, MD medicine at Mayo Clinic and as associate professor of family medicine at the Mayo Clinic College of Medicine. He earned his medical degree at the University of Minnesota Medical School. Jennifer Pecina, MD, consultant at the Mayo Clinic’s department of family medicine in Rochester and an assistant professor of family medicine at the Mayo Clinic College of Medicine, received the 2016 Researcher of the Year Award from the Minnesota Academy of Family Physicians for her outstanding contributions to the development of family mediJennifer Pecina, cine research. Pecina has 24 peer-reviewed MD publications and has become recognized for her expertise in telemonitoring of older adults with multiple health issues, as well as innovative programs for medical students to encourage their interest in primary care. Pecina earned her medical degree at Carver College of Medicine, University of Iowa.

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SEASON OPENING: OSMO VÄNSKÄ AND JOSHUA BELL Sep 22–23

Osmo Vänskä, conductor / Joshua Bell, violin Our season launches with Brahms at his most lush and Tchaikovsky at his most virtuosic, with superstar Joshua Bell adding the fireworks.

VÄNSKÄ CONDUCTS PAULUS MASS Sep 29–Oct 1

Osmo Vänskä, conductor / Kathy Kienzle, harp Power and poignancy in a beautiful blend, with Ginastera’s colorful Harp Concerto and the unveiling of a hidden gem from a Minnesota master, the late Stephen Paulus.

CELEBRATING SKROWACZEWSKI: BRUCKNER SYMPHONY NO. 8 Oct 14–15

Stanislaw Skrowaczewski, conductor Get a glimpse of heaven, as Bruckner paints a picture of otherworldly serenity and beauty in his soaring Eighth.

JOSEFOWICZ PERFORMS JOHN ADAMS Oct 20–21

James R. Hebl, MD, has been named regional vice president, Mayo Clinic Health System southwest Minnesota region, which includes six hospitals and 22 clinics. In his new role, Hebl will be responsible for overall performance of southwest Minnesota operations, including outcomes, safety, service, and financial performance. He has worked within the Mayo Clinic health system for 17 years and most recently served as chair of the division of community anesthesiology. Hebl earned his medical degree at the University of Minnesota School of Medicine and is currently James R. Hebl, completing education and training in busiMD ness administration through a collaboration between the American Society of Anesthesiologists and the University of Houston.

Edward Gardner, conductor / Leila Josefowicz, violin Sunrises from Ravel, swashbuckling from Berlioz, and a thrilling new piece by John Adams written for the blazing Leila Josefowicz.

E.T. THE EXTRA-TERRESTRIAL COMPLETE FILM WITH LIVE ORCHESTRA Oct 28–29

Steven Reineke, conductor “E.T. phone home.” Join us for an out-of-this-world experience as we screen one of the world’s most-beloved movies with the Minnesota Orchestra playing John Williams’ unforgettable score live!

minnesotaorchestra.org 612.371.5656 Ã Orchestra Hall PHOTOS Vänskä: Joel Larson; Bell: Lisa-Marie Mazzucco; Skrowaczewski: Mark Luinenburg; Josefowicz: Chris Lee; E.T. © Universal Studios All sales final. All artists, dates, programs, prices and times are subject to change.

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AUGUST 2016 MINNESOTA PHYSICIAN AUG_MN Physician Ad.indd 1

8/8/16 9:55 AM

INTERVIEW

Of the people, by the people, for the people E very four years, Minnesota Physician recognizes the 100 most influential health care leaders in Minnesota. What are your thoughts on influence and leadership and how they relate to each other? I would hope that such stature is derived from an honest, educated, thoughtful life where one’s influence flows from the confidence that this type of leadership is earned in a trustworthy way. I hope that this standard would reject false leadership claims earned in other less respected ways.

Walter F. Mondale Mr. Mondale’s record of public service includes vice president of the United States, U.S. ambassador to Japan, U.S. senator, and attorney general for the state of Minnesota. He was also the Democratic Party’s nominee for president in 1984. He recently retired from the law firm of Dorsey & Whitney LLP, headquartered in Minneapolis. He is director of several nonprofit and corporate boards and is the chair of The Maureen and Mike Mansfield Foundation. Mr. Mondale received his LLB (cum laude) from the University of Minnesota Law School and served as a law clerk in the Minnesota Supreme Court. He was a Distinguished University Fellow in Law and Public Affairs at the Hubert H. Humphrey Institute of Public Affairs at the University of Minnesota. In 1990, he established the Mondale Policy Forum at the Humphrey Institute to bring together leading scholars and policymakers for conferences on domestic and international issues. He co-teaches a class at the Humphrey Institute on the study of governance and politics.

W hat are some examples of good leadership that stand out in your mind? I loved Mike Mansfield, the former leader of the U.S. Senate from Montana. He loved and respected the Senate. He knew the issues and the rules and he gave us all the chance to show our stuff. I’ll never forget how he let me lead on the controversial issue of fair housing where I went head-to-head with some of the toughest members of the Senate. Mike was a great human being. We are all better for him. W ho have been the most influential people in your life? My parents, my brothers, my sons, and our daughter, have been an inspiration to me throughout my life. My wife, Joan, was honest, thoughtful, loving, creative, and a wonderful wife and parent. Even though I lost her almost four years ago, she remains at the center of my memory. My dear friend and magnificent leader Hubert H. Humphrey allowed me to work with him at the highest levels of government and in all aspects of public and family life. We were a wonderful team in the service of Minnesota, nationally, and indeed, throughout the world. I learned from him and remain inspired by his example. It was my honor to serve as Jimmy Carter’s vice president, the first vice president to be in the White House working directly with the president of the United States. He was always a decent, thoughtful, deeply Christian man. You could take his word on anything he told you, and while we have been separated for almost 40 years, we remain dear and good friends. We have been together longer since leaving the White House of any other presidential/ vice presidential team in American history. H ow have you seen cultural differences affect either the perception or process of leadership? We are finding in our experience with new immigrant populations, for example, that they bring with them deep cultural characteristics by which they may judge central questions of leadership somewhat differently from others. For example,

MINNESOTA PHYSICIAN AUGUST 2016

Japan is a democracy and they mean it, but they do express it differently. The value of consensus is very important to them and there is much less party partisanship there. re there traits that you see as universal A to the quality of leadership, regardless of the arena? I believe that the basic qualities of leadership— honesty, excellence of learning and judgment, caring, and kindness—remain central qualities required of all of us. W hat is your take on how things have gone with the Affordable Care Act (ACA)? I served for years in the Senate on all of the committees dealing with American health challenges. I believe many of these essential costs are beyond the reach of individuals who must be provided such care. I tried to make a difference in our policies as an early supporter of Medicaid and Medicare and as a proponent of the Affordable Care Act. I think the early mistakes and growing pains are to be expected and we need to work together to improve the ACA. This requires an attitude of openness and cooperation in which our respected medical profession can do so much. I was struck by how the cooperation and mutual respect at the center of the earlier programs was significantly missing with today’s marked political warfare. Y ou bring up an excellent point that enacting a new bill like the ACA isn’t going to solve our health care issues overnight. Are there parallels to the problems we encountered as a nation when enacting the Civil Rights Act of 1964 that could help bring perspective? Yes, there are abundant examples of how we slowly developed stronger answers to the goal of strong national rules against racial discrimination. Housing has been a tough and deeply emotional issue. I authored the original Fair Housing Act but for several years, courts would often disagree with the idea of “disparate impact” of housing policies that ended in discrimination based on race. Unless you could prove that the agency had deliberately intended this result, the court might rule that the federal act intended no such result. This year, the U.S. Supreme Court finally found that the Federal Fair Housing Act did indeed include the disparate impact rule so that actual discrimination, regardless of intention, was what the court could consider. This is a big change and a fundamental step by the Supreme Court. It could have a big impact here in Minnesota. We are now confronted with a big change in how the court looks at the preclearance requirement in the Voting Rights Act for legal changes

affecting discrimination in states with a strong history of such discrimination. For most of the years since adoption of our federal anti-discrimination laws, the South has had to seek pre-approval for proposed changes in their laws. Alas, the court, a few years ago, removed that requirement. We now are seeing widespread weakening of anti-discrimination law throughout much of this area, with deep and profound consequences. W hat do you see as the biggest problems facing our health care delivery system today? The open political warfare over the terms, or indeed, as to the very existence of a universal American health care system still surrounds the debate over our new health care system. Surely the American medical profession should be centrally involved in improving our Affordable Care Act.  What do you see in the future for health care delivery? I think the political bedlam surrounding the adoption of our Affordable Care Act will settle down to a realization that we need something like the Affordable Care Act. But

how can we work together to improve it and make it more efficient? And, where we’ve agreed to depend upon our market system, how can the ACA be developed into a more efficient and reliable system?

We need to work together to improve the ACA. Y ou are in a unique position to observe a transformation in the political process and how political leadership is perceived by society. What can you tell us about this? This is your toughest question. Polls show a distinct and even alarming public distrust of our political system, its politicians, and the ensuing deadlock in our democracy. Maybe we have had other instances of this in American history, say over the last century of our existence, but I don’t remember it. I think the big unaccountable money sloshing around our system since the court’s tragic Citizens United decision to remove all limits and all other restraint

on big money, has created a system that’s up for sale and simply cannot be trusted. Indeed, the worst part of this problem has been the destruction of public trust. resuming that the political process P needs to be or can be improved, do you have any suggestions? Yes, as always, we must call on our citizens to be alert and engaged. So too, we must insist that political leaders respond fully to Lincoln’s great challenge that our system must be based on the ideal government of the people, by the people, and for the people. O ur society is shaped by those who assume positions of leadership whether in politics or medicine. What advice do you have for those who aspire to be leaders? Well, do your job the very best you can, fully respect our citizens, and listen with great care to their concerns. Many of our most challenging issues require the help of gifted medical and other professionals who can better help us to understand what we must do and how it might best be done. So remember that you are needed.

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AUGUST 2016 MINNESOTA PHYSICIAN

Hamid R. Abbasi

Sue Abderholden

Partner/Surgeon Tristate Brain and Spine Institute

Executive Director NAMI Minnesota

Changes: Over the last four years, we established ourselves as a world leader in minimally invasive spine surgery. We fine-tuned and made Oblique Lateral Lumbar Interbody Fusion (OLLIF) a routine procedure. Spine surgery that once took four hours to complete is now done in only 40 minutes with tremendous success and benefits to our patients.

Changes: We have been working hard to increase the mental health literacy of families; people who work in health care or with youth and older adults; employers; and first responders. We have also greatly increased our work on suicide prevention and safe messaging.

MD, PhD, FACS, FAANS

Challenges: Our biggest challenges are related to bringing the OLLIF procedure and related technology to more patients. Currently, additional surgeons are needed to perform this cutting-edge procedure. We’ve had national and international surgeons come to our facilities so we can train them. We have also published in peer-reviewed journals to highlight the superiority of OLLIF.

Craig Acomb

100 Influential Minnesota Health Care Leaders In preparing this feature, we asked each of the nominated health care leaders to answer two questions: 1

What are the biggest changes your organization has made in the past four years?

2 What are the biggest challenges these changes will face in the next four years?

We invite you to read their responses.

MINNESOTA PHYSICIAN AUGUST 2016

MPH

Challenges: Our mental health system isn’t broken—it has never been built. Increased awareness has led to more people seeking treatment and the realization that we are not meeting their needs. How we build on what we know works in the community, while at the same time ensuring access to acute care, is our biggest challenge.

Brian Amdahl

Interim President and CEO Institute for Clinical Systems Improvement

MD, MMM

Changes: We have continued to pursue our collaborative focus on the Triple Aim goals of better care, smarter spending, and healthier people. Our accomplishments include leadership on integrating behavioral health into primary care, award-winning work to reduce avoidable hospital readmissions, and pioneering efforts to help medical groups forge partnerships with their communities to accelerate improvements in health.

Changes: We have transitioned from siloed care delivery areas to a systematized care continuum approach, integrating acute hospitals, clinics, postacute care programs, and community services into a single care delivery business unit. Unified operational and medical director oversight, as well as shared clinical care pathways and personnel, has improved patient safety and overall experience during care transitions. Streamlined electronic medical records support seamless delivery of critical medical data. These changes align with customers’ expectations for fully integrated care.

Challenges: We know that health care will continue to evolve rapidly, and the need for a coordinated community approach to robust measurement, clinical care innovation, aligned payment models, and consumer engagement will be critical to achieving our collective goal of better value for our investments in health.

VP and Executive Medical Director Post-Acute Care, Medical Specialties HealthEast

Challenges: We need to be aware of our customers’ continually evolving expectations, and be nimble enough to quickly change processes to deliver care when, where, and how it is desired.

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Tom Arneson MD, MPH

Research Manager Office of Medical Cannabis Minnesota Department of Health Changes: The 2014 law that established the Minnesota Medical Cannabis Program tasked the MDH with running it and set a tight timeframe to make it operational. Having key aspects of the program differ from most other states’ medical cannabis programs added to the challenge—and opportunity (laboratory-tested extraction products with specified cannabinoid content; participant experience). Challenges: Cost has emerged as a major issue, because the medical cannabis products available through the program are quite expensive and not covered by insurance. A rapid, feasible solution to this issue is not in sight. There is widespread lack of awareness among clinicians on what is known about the endocannabinoid system and research into therapeutic potential of plant-based cannabinoids and synthetic modulators of the ECS.

Hanna E. Bloomfield MD, MPH

Ruby Azurdia-Lee

Susan A. Berry

Joseph Bianco

Immediate Past President Minnesota Chapter of the American Academy of Pediatrics

Chief of Primary Care Essentia Health

Changes: We worked to increase the number of active member advocates and enhance engagement with other primary providers who care for children. In collaboration with others, we were successful in changing newborn screening in Minnesota. This restored the ability of the Minnesota Department of Health to maintain records of the life-saving early screening assessment, which is an essential public health measure.

Changes: Our movement from volume-based to value-based reimbursement has led us to completely transform our practice. By continuing to strive to meet the goals of the Triple Aim, the changes to all aspects of our care delivery are profound.

President CLUES

Changes: We promote integrative approaches to access health care and stimulate community well-being. Latinos in Minnesota continue to experience increased barriers and a lack of culturally and linguistically appropriate treatment. We focus on a model of service that advances two generations forward and out of poverty. Our services work with families in a holistic way, and we emphasize prevention and behavioral change. Challenges: The explosive growth of Latinos in Minnesota will necessitate our innovation and cultural and bilingual responsiveness in the provision of health and wellness services. Most Latino families today have mixed immigration status, and some face barriers to accessing health care. The stresses of acculturation can impact health outcomes and the healthy functioning of the family, which we want to strengthen.

Bob Bonar MA, MS, DrHA

Associate Chief of Staff for Research Minneapolis VA Medical Center

CEO Children’s Minnesota

Changes: The biggest changes we have made are to prioritize the growth of clinical and health services research, strengthen research infrastructure (e.g., personnel, equipment, data management systems), and remodel space to better meet the needs of clinical and basic science researchers.

Changes: We’ve developed laser focus on producing top outcomes for the children and families that we serve, across our hospitals, specialty clinics, primary and virtual care settings. There’s an art and science to pediatrics and I’m very proud of what our team has accomplished.

Challenges: The biggest challenge for the Minneapolis VA Research enterprise is to recruit a new generation of well-trained investigators who are passionate about conducting well-designed research projects that address the major health care problems affecting veterans, including post-traumatic stress disorder, obesity, cardiovascular and metabolic disorders, and diseases of the aging brain.

Challenges: What Children’s offers this community is unique. We know that kids do best in a health environment that’s dedicated solely to kids. As the industry continues to transform, we must be courageous, innovative, and selfless in partnering with others to protect this asset and to ensure better health for our kids.

MD, FAAFP

Challenges: As advocates for children, our group needs to remain vigilant, focused, and committed. Positive change happens with attention and preparation.

Challenges: Working to promote the health and well-being of not only our patients, but our workforce will be a great challenge in the midst of rising prevalence of chronic disease. We will need to partner with our communities to address health behaviors and the social determinants that lead to disease. The challenge will be to create the partnerships that will lead to positive outcomes.

Mary Brainerd

Matt Brandt

President and CEO HealthPartners

CEO PrimaCare Direct

Changes: We’ve expanded care options, in person and virtually, where we’ve provided over 200,000 treatments, and over 20 worksite clinics, including virtuwell. com, our online medical clinic. We’ve created more affordable options using measurement tools like Total Cost of Care. We’re serving more people: twice as many patients and 38 percent more members than five years ago.

Changes: PrimaCare Direct has expanded to include 13 practices with 20 clinic sites. By expanding the network of clinics, we are now able to offer employers primary care services for a low monthly membership fee to all their employees across the Twin Cities.

Challenges: Care will come to patients— at work, at home, or on their phones— and fundamentally change how we relate to them. Our efforts to tackle mental health stigma, health care disparities, early childhood development, opioid addiction, obesity, and chronic disease will create healthier communities. We’ll remain focused on affordability, measuring cost, and quality to improve results!

Challenges: The current economics of health care make it tough to change. Premiums continue to rise placing a burden on employers, governments, and patients, however the flip side is that more money is flowing into the health care system. Innovative models that try to disrupt these burdens meet a lot of resistance from the current health care players. I see this battle daily.

AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Shirley A. Brekken

Sally T. Buck

Christopher Cassirer

Steven Connelly

Executive Director Minnesota Board of Nursing

CEO National Rural Health Resource Center

President and CEO Northwestern Health Sciences University

President Park Nicollet Health Services and HealthPartners Institute

Changes: We’ve focused more on changes in the environment rather than on internal organization. Technology, economics, the ACA, millennials entering the field, and greater utilization of nurses in primary care are causing a historic transformation of health care. Increased scrutiny of the effectiveness and efficiency of regulatory models demands increased transparency and accountability.

Changes: The Center has been collaborating and innovating to improve rural health for over 20 years. Our services have expanded beyond rural clinics and hospitals to health networks and communities. We continue to develop and disseminate knowledge of the new models for rural providers and identify strategies to bridge the gap between the current structure and the emerging environment.

Changes: We are committed to optimizing patient, family, and community health through nutrition, early diagnosis, and treatment. We work in partnership with conventional health and medical providers to start with conservative, natural approaches to care before considering more aggressive treatments like drugs and surgery.

Changes: The combination of Health Partners and Park Nicollet in 2013 is certainly the biggest change. The cultures of the two organizations were extremely similar before the combination, as they both centered on the Triple Aim. This allowed us to concentrate on and accelerate our efforts around health outcomes and affordability.

Challenges: We must implement regulatory solutions with increased relevance and responsiveness to the changes in health care, the transformation of education, and emergent trends in workforce and population health. Greater mobility, response to emergencies, and communication with patients across state borders call for a new licensure model that supports interstate practice. Regulation must be innovative and pragmatic.

Challenges: The Center has witnessed a growing number of challenges facing rural providers. They are striving to maintain local health care resources including workforce, technology, and capital, while preventing the out-migration of patients and adapting to value-based purchasing from being reliant on quality, population health, and patient satisfaction.

MS, RN

ScD, MPH

Challenges: Our challenge is to prepare our graduates for a rapidly evolving health care system and educate communities that the best approach to health is to prevent disease. The best primary care option isn’t to take a pill, but to first try natural care solutions like chiropractic, acupuncture, therapeutic massage, getting more rest, or improving nutrition. We want to be culturally aware that the communities we serve are diverse and may have different health traditions.

Challenges: Addressing patients’ needs in an ever-changing environment is a growing challenge. We must offer options—from traditional office visits to telemedicine, to virtual and online care. Also, we need to continually improve the current EMR functionality to contribute to a more efficient and fulfilling clinical practice. We must address this to succeed in providing access.

Your Link to Mental Health Resources

MINNESOTA PHYSICIAN AUGUST 2016

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Kathryn Correia

Kent Crossley

J. Kevin Croston

President and CEO HealthEast

Chief of Staff Minneapolis VA Healthcare System

CEO North Memorial Health Care

Changes: Implementing lean and aligning leadership to reach our strategic objectives were some of the biggest changes we’ve undergone over the past four years. We made those changes while rolling out our new electronic health record—so, these were courageous decisions to be sure. With a clear focus on best serving our patients, physicians, employees, and community, these were the right decisions.

Changes: The Minneapolis VA has expanded available specialty services, increased its number of community clinics, grown its education and research activities, and worked to be more patient-centric. We offer same-day access in primary care and mental health, have developed a comprehensive integrative health program, and offer online services and provider access. Our tele-health and tele-ICU programs are state of the art.

Changes: We transitioned from being a hospital that owns clinics to that of a value-based health care delivery system. We improved health care access and services in the ambulatory setting and introduced online care and retail clinics. We also placed our customers squarely in the center of our decision-making so our work is entirely mission-driven.

Challenges: Our biggest challenge will be to continue to reduce the burden of medical care as we work in partnership with our patients and our communities to improve health and well-being.

Challenges: The VA is the largest provider of health care in the U.S. and part of a complex system. Decision-making may be a challenging process. Our leadership may change with the presidential election and this could lead to modification of our current priorities.

MHA

MD, MHA

John Dahm

President and CEO Accra

Challenges: Value-based reimbursement requires collaboration between customers, providers, and payers, but the insurance industry is reluctant to compensate smaller systems equitably. While our small size lets us make necessary changes faster, we aren’t currently rewarded for these efforts by payers. Larger systems are paid more because of market share dynamics that reward patient access over outcomes. To offset this inequity, we need to empower our customers to achieve their best health.

Changes: Our biggest changes were driven by rapid growth while experiencing unprecedented change in our industry. We created efficiencies within our systems and added staff to ensure that we meet and exceed the needs of our participants and our mission. Our focus also included participating in stakeholder groups, and working with other organizations and thought leaders to influence change. Challenges: The greatest challenge will be the changing demographics that will result in the demand for more people needing services and a reduced workforce to meet their needs. Our focus will be to manage this continued growth and the rapidly changing regulatory environment, while continuing to help families and older adults find what services are available to meet their needs.

Simple. efficient. ingeniouS. We evaluate and treat all types of brain and spine problems, no matter how complex. Our team of renowned, world-class surgeons, is committed to living and serving the communities of the Midwest and beyond.

Healthcare Planning and Design

Our areas of specialty include: • International leadership, presenter and author in the advanced minimally invasive OLLIF Spinal Fusion Procedure. • Minimally invasive SI Joint Fusion offering rapid recovery and relief. • Better imaging results without the claustrophobia of a conventional MRI test, our open, upright MRI scanner is one of very few in the U.S.

We offer clinical care at the following locations: Tristate Brain & Spine Institute • Alexandria MN River View Health • Crookston MN Advanced Spine and Pain Clinic • Edina MN Dr. Hamid R. Abbasi mD phD fAcS fAAnS Board certified neurosurgeon

Dr. Sunny S. Kim mD Board certified orthopedic Spine Surgeon

(320) 763-8888 www.tristatebrainspine.com

Essentia Health, St. Joseph’s Clinic; Brainerd, MN

Duluth, MN | 218.727.8446 Minneapolis, MN | 612.338.2029 Cambridge, MN | 763.689.4042 Superior, WI | 715.392.2902

AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Bobbi Daniels MD

CEO University of Minnesota Physicians Changes: We established an enhanced collaboration with Fairview called University of Minnesota Health, which paved the way for our Clinics and Surgery Center, enhanced financial support for the medical school, and greater integration of UMP and UMMC. We developed a new ambulatory care model coupled with a different architectural design and expanded hours to enhance the patient experience and our ability to do clinical research and education. Challenges: We will need to continue to innovate in all parts of our commitment to academic medicine and work with partners who share that goal. Patient care needs to become even more patient focused, evidence based, and efficient and that goal takes on additional importance as we educate the next generation of health care professionals.

Mark Dayton

Rhonda Degelau

Edward Ehlinger

Executive Director Minnesota Association of Community Health Centers

Commissioner Minnesota Department of Health

Changes: We’ve focused heavily on preparing member clinics to participate in accountable care models, such as the Medicaid Integrated Health Partnerships, and to prepare for a value-based payment world. We’ve also stepped up our advocacy work on emerging payment reforms at the national and state levels, to ensure that new payment models work for safety net clinics.

Changes: To address health equity, we created the Triple Aim of Health Equity, which provides the framework for the transformation of public health practice. These aims include using a health in all policies approach, with health equity as the goal; expanding our understanding of what creates health; and strengthening communities to create their own healthy futures.

Challenges: Current marketplace and legal barriers to Health Information Exchange will limit successful participation in accountable care models. Our member clinics also face financial resource barriers to securing the data analytics capacity needed to succeed under new models. We must ensure that payment reform works for the safety net by recognizing the impact of social determinants of health on health outcomes.

Challenges: The dominant public narrative is that health is created by access to high quality health care and good personal choices. The biggest challenge is for people to understand that health is mostly due to the physical, social, and economic environments in which they live, and that to improve health in a socially responsible way, we need to invest in community-wide public health efforts.

Governor of Minnesota

Changes: Minnesota has been a national leader in health care reform. Our uninsured rate has been cut in half, and is now the second lowest in the nation. We have implemented reforms to improve health and lower costs in our public health care programs, including a competitive bidding process for managed care contracts. Integrated Health Partnerships in Minnesota’s Medicaid program have saved $150 million, while providing better care to low-income Minnesotans. Challenges: Big challenges remain, such as an aging population, persistent health inequities among Minnesotans, and better access to mental health and dental care, especially in Greater Minnesota. It will take all of us working together to meet these challenges, while keeping health care affordable for Minnesotans who need it.

MINNESOTA PHYSICIAN AUGUST 2016

MD, MSPH

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

James W. Eppel

Al Franken

President and CEO UCare

U.S. Senate

MD, FCCP, FAASM, CPE

Changes: This has been a period of great change in health care and at UCare. We have entered the individual commercial market on MNsure, introduced value-based relationships and “private-labeled” products with our delivery system partners, and experienced significant growth, followed by significant contraction.

Changes: Because of the ACA, we’ve seen the rate of uninsured Americans fall below 10 percent nationally, and under 5 percent in Minnesota. Because of the provision I wrote in the ACA, known as the Medical Loss Ratio, insurance companies are now required to spend more on health care and less on administrative costs, saving consumers billions of dollars.

Challenges: The exchange market remains immature and volatile; we all have to work together to find solutions. Despite the high level of collaboration today, we have significant work to do to reduce health care costs. The entire health care system will need to focus on viewing our world through the patient’s eyes, recreating the system accordingly.

Challenges: We need to focus on delivery system reform. I think Minnesota is a great model for the rest of the country. For example, in the ACA, I helped establish the National Diabetes Prevention Program, based in part on work done in Minnesota. So far, the results have been clear: not only does this program make people healthier, it also saves taxpayers a significant amount of money.

Kevin Garrett

Julie Gerndt

Senior VP, Chief Medical Officer HealthEast

Chief Medical Officer Mankato Clinic, Ltd.

Changes: A redesign of our care delivery system included the creation of dynamic, dyadic relationships between operations leaders and our physician leaders. This has allowed us to keep everyone moving in the same direction, led by the same strategy. We have also continued our efforts to deepen our culture of continuous improvement.

Changes: We have focused on relationships with our community and with one another. Full engagement of providers in leading change and cascading goals and incentives down to front line staff has been key in producing the best health care outcomes for our patients. We are fully transparent about outcomes and the use of care-related data to improve our work.

Challenges: Staying aligned with the right work to better respond to evolving community needs; providing capacity for physicians to find a pathway to personal and professional success; and continuing to move in a strategic, unified direction.

Challenges: Our ongoing success will hinge on keeping pace with changes in payment and providing access for patients in the face of a physician shortage. We will address provider burnout by further developing our care teams, expanding our use of technology, and developing purposeful leadership.

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AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Dean Gesme

H. Theodore (Ted) Grindal

Julia U. Halberg

Peter J. Henry

President Minnesota Oncology

Partner Lockridge Grindal Nauen, PLLP

Chief Wellness Officer, VP Global Health General Mills

Chief Medical Officer Essentia Health–Brainerd

Changes: We continue to grow with many new physicians and expanded utilization of advanced practice providers to integrate a broader range of patient services including palliative care, genetic assessment, survivorship care, and end-of-life counseling in addition to our core services. Outcomes measurement and reporting have driven improved internal efficiency, enhanced value delivery, and high patient satisfaction.

Changes: The biggest changes for my clients have been complying with the ACA and reacting to the continued consolidation in the health care delivery system in Minnesota. Also, there seems to be no reason to believe that continued integration in the health care provider market will not continue to leave us with even fewer large delivery systems.

Challenges: The cost of breakthrough therapies for our cancer patients has reached unsustainable levels. Preauthorization and payment approvals have frequently resulted in delays of potentially life-saving treatment. The complexities of precision medicine, expanded diagnostic testing, and complicated new therapies requires greater time and attention by providers in an environment in which many of these cognitive services are unreimbursed or under-reimbursed.

Challenges: Managing costs and quality will only continue to be more challenging. Purchasers are demanding both and all the large health care delivery systems are embracing these priorities. The pressure on providing lower costs and higher quality will be supported by more and more data analytics. The ability to access and manage this data will continue to impact every level of the delivery systems.

Changes: Transitioning from a company-owned, prevention-based, onsite clinic with specialties (dental screens, cardiology, optometry, PT) to a Wellness Center. While our onsite clinic was outsourced, we’ve added integrative services (acupuncture, nutrition, aromatherapy) and also designed Zenergy rooms where employees can re-energize in zero-gravity chairs, use brain-fitness technologies such as MUSE, or nap.

Changes: To ensure access for patients in rural communities, we’ve expanded our clinical team to include advanced practice clinicians. As our teams have grown, standardizing our workflow in primary and specialty care has improved the quality of care all patients receive. We are becoming a truly integrated health system, where the community and patients are seen as “ours” to care for.

Challenges: Evolving an ongoing innovative, holistic (mind, body, community) approach to the well-being of our employees; identifying technologies and programing that engage our employees to be active, make healthy nutrition choices that incorporate our Brands (Cheerios, Annie’s, Yoplait, Nature Valley); and connect with the community by volunteering—making their time at work the healthiest and safest time of their day.

Challenges: Although the quality of life and teamwork are strong differentiators, it’s a challenge to attract candidates who want to care for patients in rural communities. Continuing to evolve and improve patient care makes all health systems better and benefits our communities. As health care moves to a value payment model, aligning compensation to this change will pose new challenges.

MD, FACP, FASCO, FACPE

MD, MS, MPH

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MINNESOTA PHYSICIAN AUGUST 2016

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

John R. Hering

David C. Herman

Patrick Herson

Ken Holmen

Chief Medical Officer CentraCare Health–Monticello

CEO Essentia Health

President Fairview Medical Group

President and CEO CentraCare Health

Changes: In 2013, our Critical Access Hospital transitioned from an independent organization run by a hospital district to a regional affiliate of CentraCare Health. Our patients and community have benefited tremendously from the additional resources and support that come from being a member of a large health system.

Changes: We have made the commitment and built new systems to support the move from volume to value. The design of our Primary Care team model, along with the great support our care teams provide our patients, have dramatically improved our ambulatory care quality measures. We are working to sustain the resilience of our staff as well.

Changes: As a multispecialty group that is only seven years old, we have embraced being integrated and interdependent. This has meant having challenging conversations about where to invest in new programs and areas of growth, and how to have one set of clinical and financial standards across an almost 600 provider group. We have also begun to do the necessary work to succeed in a value-based model.

Changes: We recognize that our employees and physicians ultimately make the difference in how well we serve our patients and the community. Based on a culture change transformation, we migrated our organizational structure so executives and physicians share responsibility for leading all clinical service areas. Then we realigned our governance structure to ensure optimal oversight of our strategic initiatives.

Challenges: The biggest challenge we face is our intensely competitive market; multiple health systems converge in our area. It is vital for us to work collaboratively with our local physician partners, most of who are in independent practices, to ensure that we deliver the quality and value of care our community deserves.

Challenges: Health care in a community accounts for just 10 percent of residents’ health status, while socioeconomic factors, behaviors, and the environment contribute to 80 percent of overall health. Our challenge is building strong partnerships within the communities we serve to address those factors to keep our communities healthy, while continuing to build the systems of care needed when people become ill.

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Challenges: We want to perform well across a balanced scorecard of measures including clinical quality, patient experience, provider and staff engagement, and financial excellence. It is relatively easy to perform well on one or two—it is much more challenging to perform across all of them in a balanced fashion.

Telephone Equipment Distribution (TED) Program

Challenges: Whenever organizations attempt deep and systemic change, they risk having insufficient employee engagement to sustain the work. Understanding this, we have processes that regularly re-energize and support our team. We plan to develop change management tools that employees will need to ensure success under the new structure. This is essential to recruit and retain excellent people in a competitive labor market.

Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.

1-800-657-3663 ted.program@state.mn.us mn.gov/dhs/ted-program Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Dan Holub

Mary Hondl

Maria Huntley

Brooks Jackson

Executive Director Minnesota Association of Professional Employees

CEO Regional Diagnostic Radiology

Executive Vice President Minnesota Academy of Family Physicians

VP for Health Sciences and Dean of the Medical School University of Minnesota

Changes: Our newer members are looking for a greater sense of connection to their workplace and union. As a result, we are more relational in the way we approach our work. We led efforts to establish better parental leave for state employees, because a newer group of members took up the issue, organized around it, and created positive change.

Changes: HealthCare Reform has affected every aspect of operations for providers and health care facilities, and we have focused on understanding those regulations. We developed additional practices and policies to meet and exceed compliance standards, while providing the best possible care to our patients and serving our referring clinicians.

Changes: In 2015, our Legacy Staff Leader of 30 years retired. I arrived with a whole new set of experiences and expectations to help drive change. We are evolving as an organization to ensure that we meet the needs of all of our members and keep up with industry trends.

Changes: I have increased scholarship and developed new interprofessional practice models across all our health sciences schools, increased diversity in our student body, promoted groundbreaking research, and brought the best possible clinical care to people across the state. We also launched an initiative in partnership with the state to create Medical Discovery Teams focused on pressing health issues facing Minnesota.

Challenges: Our biggest challenge is organizing professional employees in a way that results in positive change and builds relationships. Like everyone else, we are trying to control rising health insurance costs without sacrificing quality. We will also continue to prioritize healthy work climates that are free from bullying and other conditions that impact mental and physical health.

MBA

Challenges: Continuous regulatory changes are a big challenge. Advanced technology is essential for producing metrics and meeting the reporting requirements, but comes at a high price. Educating physicians and staff on new ways to practice and on new reporting processes is necessary, yet takes time. We are working with our hospitals and referring clinicians to meet these challenges and with this team approach, we are confident that our community will be well served.

CAE, MAM

Challenges: I am excited about the opportunities these changes are going to bring to family physicians. We are actively working to cultivate diverse future leaders in family medicine. We will do this by offering our members not only top notch CME, but enhanced networking and advocacy support.

MD, MBA

Challenges: Health care is changing rapidly with an increasing focus on bundled payments and team care, while higher education is struggling with declining state support. High quality facilities and faculty is critical to providing leading edge education, research, and care. Building partnerships to ensure necessary resources will continue to be a priority.

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100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

William Katsiyiannis

Nissim Khabie

President and Chairman of Cardiology Minneapolis Heart Institute; Abbott Northwestern Hospital/Allina Health

President ENT Specialtycare

Changes: While there is a rich history of innovation in cardiovascular medicine, from surgery to stents to pacemakers, we are now innovating in the delivery of cardiovascular care. This means evolving from practicing in silos to practicing in coordinated teams. We’re also recognizing and reducing unnecessary variation in care. These innovations have improved quality and reduced costs.

Changes: Although the EMR is ubiquitous in physician’s offices and hospitals, we are just beginning to scratch the surface in terms of optimal utilization of technology to improve effective and efficient patient care. Although we have already aligned our practices with care systems and independent groups, with the advent of ACOs and changes in payer models, we are seeing an acceleration in developing these relationships.

Challenges: The next four years will challenge us to balance the tension between novel and innovative care delivery and the antiquated reward systems that currently exist. Many of the needed changes in care delivery currently carry negative financial incentives for providers and health systems.

Challenges: Our increased utilization of technology will improve data collection and best practice elements, and will expand our reach to patients via improved portal access and telemedicine. We need to leverage our experience in delivering top-notch otolaryngology care with the advantages inherent in having a patient-centered medical home and integrating best practices into these systems.

Amy Klobuchar

Rahul Koranne

U.S. Senate

MD, MBA, FACP

Changes: I have focused on bringing down the high prices of prescription drugs. That’s why I’ve introduced the Medicare Prescription Drug Price Negotiation Act to empower Medicare to negotiate for the best possible price of prescription medication for seniors; the Safe and Affordable Drugs from Canada Act to help Americans access safe, affordable prescription drugs from Canada; and the Preserve Access to Affordable Generics Act to expand consumers’ access to cost-saving generic drugs.

Changes: In order to continue to deliver the best health care in the nation, Minnesota’s health systems are re-engineering the value chain of outpatient offerings, hospital care, and home and community-based services. Financing innovations in Medicare and Medicaid are increasingly supporting these new delivery models.

Chief Medical Officer Minnesota Hospital Association

Challenges: The increasing prices of prescription drugs are a huge burden on families across the country. One in five Americans skip medication doses or decline to fill a prescription because of cost concerns. I’ll continue working with my colleagues from both sides of the aisle to pass these bills into law.

Challenges: Ensuring true patient, family, and community engagement with health care stakeholders; reducing burnout while increasing clinician satisfaction; and transforming the overall financing of health care in order to reduce the burden being placed on society remain mission critical work in progress. Information technology vendors and pharmaceutical companies will be key in supporting the goal of improving population health.

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www.ProjectTurnabout.org AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Kelby K. Krabbenhoft

Gayle M. Kvenvold

Richard F. Kyle

President and CEO Sanford Health

President and CEO LeadingAge Minnesota

Chairman Emeritus, Department of Orthopaedics Hennepin County Medical Center

Changes: After significant growth from 2007 through 2013, we fully aligned our 1,500 physician clinics, care institutions, and health plan. All necessary competencies are established to support alternative payment models and maximize value for patients. Sanford also refocused its research efforts in areas with the greatest potential for patient care (genetics, genomics, immunotherapy, and cellular therapies).

Changes: Expanding our membership for a growing array of senior care services, particularly new configurations of housing, including services for both post- and pre-acute care and home and community based services—for example, we just merged with Minnesota Adult Day Services Association. Finding solutions to our growing workforce challenges is a priority, alongside performance and quality improvement.

Changes: We moved to computer documentation of all records for patient care from physicians, physician assistants, and nurses. Overall, the records are certainly more accessible and organized with computer navigation. Patients who are computer savvy have access to their information, which is good.

Challenges: Driving the shift from volume to value requires aligning interests external to Sanford, including consumers, employers, independent providers, government, and private insurers. Application of medical discovery is constrained by bureaucracy. An efficient process to assess new treatments is as critical as ensuring their safety and efficacy.

Challenges: We’ll strive to find the common causes that ignite passion and fuel action among diverse constituents, while meeting the specialized needs of an individual member segment. Keeping pace with the unprecedented amount of experimentation in new service delivery and payment models, gathering and analyzing relevant data, and creating tools providers and consumers will need to work across siloes of care.

MBA

MSW

Challenges: We must make time for adequate patient contact including examination, counseling, and personal interaction during clinic and hospital visits despite time spent documenting on the computer. Communicating with patients on a personal level is incredibly important. I am concerned about the accuracy of entering data when providers want to save time and get back to patient care. Data that is not accurate when initially entered may lead to errors in patient care.

Leota Lind CEO South Country Health Alliance

Changes: Building on our existing partnerships and care model, we met the increased demand for data to support value-based care and local health care reform initiatives. We are working toward implementing an HIE that will provide interoperability between disparate electronic medical records, and that allows us to work collaboratively with our providers and counties, coordinate services, and reduce costs. Challenges: As we face an aging population and workforce shortages in our rural communities, technology that provides data and analytics becomes crucial to improving health outcomes, operational efficiency, and reducing costs as regulation increases and reimbursement continues to trend downward. We must continue to look for opportunities to collaborate with our communities to ensure access to quality and cost-effective local health care.

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100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Jeff Lindoo

Richard L. Lindstrom

Jennifer P. Lundblad

Susan M. Markstrom

VP of Governmental and Regulatory Affairs Thrifty White Pharmacies

Founder and Attending Surgeon Minnesota Eye Consultants

President and CEO Stratis Health

Chief of Staff St. Cloud VA Health Care System

Changes: We expanded the use of technology for product fulfillment and product offerings to include specialty medications. We also engaged our pharmacists in clinical services to transition the community pharmacist from a provider of product to a provider of patient care services to help control the total health care spend.

Changes: We are growing 8–10 percent per year and will be opening a new facility in Woodbury next year. We continue to add new providers to help us meet expanding needs of an aging population and growing community. Our advances include: presbyopia correction surgery, minimally invasive glaucoma, advanced corneal transplantation, aesthetic and functional ophthalmic plastic surgery, and new therapies in dry eye and ocular surface disease.

Changes: Improving quality and safety continue to be our focus and we translate research into practice to improve care. The widespread recognition that the majority of health happens outside formal care settings has led us to test new models of care. Some of our most groundbreaking work has the community as the unit of improvement, reflecting the need to address population health and social determinants.

Changes: We have a strong commitment to providing highly accessible care. To meet that need, we developed and expanded our telemedicine program. Through multiple modalities, we are connecting veterans with physicians not only within our system, but throughout the nation. Additionally, the Choice Act was signed to further enhance access. Considerable effort and resources have been focused to stand up this program and develop strong networks with community hospitals and medical services.

RPh

Challenges: We want continued access to our patients through pharmacy network contracts and maintaining sustainable reimbursement for product and clinical services. We are working with state and federal legislators and regulators to ensure an environment that allows patients to receive the full benefit of a pharmacist’s clinical training and expertise from the pharmacy of their choice.

Challenges: The biggest challenge is managing decreased reimbursement while, continuing to provide high quality care, new technology, and an extraordinary patient experience. It is critical, and we are deeply committed, to enhance the value we bring to each individual patient; the third party payers; and the Minnesota and Midwestern community we serve.

PhD, MBA

Challenges: It is an exciting time in health care, and we are thriving in the midst of change. Our new work requires creative and strategic thinking; disciplined approaches in engaging patients; focusing on the health of populations; developing meaningful collaborations; integrating care delivery across settings and into the community; and using robust data analytics.

H O P I TA L S

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Challenges: Recruitment of health care professionals is an ongoing challenge in today’s market. Connecting with our community non-VA partners requires strong care coordination and communication to assure seamless care. This can be challenged by an EMR that is separate and distinct from the private system’s records. Sharing medical information with our Choice Act community partners is often challenging.

Creating

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100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Ruth M. Martinez

Lawrence J. Massa

David McKee

Robert K. Meiches

Executive Director Minnesota Board of Medical Practice

President and CEO Minnesota Hospital Association

CMO, Integrity Health Network Northland Neurology and Myology, P.A.

CEO Minnesota Medical Association

Changes: Minnesota enacted the Interstate Medical Licensure Compact (IMLC) and we are working to issue expedited licenses in 2017. We are implementing legislative changes to statutes, including the addition of two new license types (genetic counselors and medical faculty); making modifications to the medical, physician assistant, and traditional midwifery practice acts, chapter 214 relating to temporary suspension of health provider licenses, and chapter 152 relating to mandatory prescriber registration; and expanding access to the prescription monitoring program.

Changes: We, along with our hospital and health system members have led significant work to improve health care quality and safety for patients and families across Minnesota. We are among a select group chosen to participate in the Centers for Medicare and Medicaid Services’ Partnership for Patients, to reduce preventable hospital-acquired conditions by 40 percent and readmissions by 20 percent.

Changes: The most significant changes at IHN relate to moving from a successful utilization of the shared savings model to the more demanding requirements of TCOC especially as it relates to our MSSP ACO. We established one of the first ACOs in the state and have continued collaboration between primary and specialty care physicians to establish optimal care protocols.

Challenges: Minnesota’s hospitals and health systems will strive to deliver the highest-quality health care; ensuring meaningful access and holding down the rate of health care cost growth. They will adopt and leverage new technologies and transform the way caregivers work together as a cohesive and coordinated team to improve the health of individuals over their lifetime and entire communities over generations.

Challenges: Penalties exist for groups that were high quality/low cost before establishing the ACO. Since success is defined by reductions in cost and improved quality metrics, IHN, is punished for its past success. We also face a CMS-invoked disadvantage in reimbursement relative to hospital-owned clinics. We will continue to do more with less, while integrating data from numerous clinics over different EHR platforms.

Changes: We have worked to be more responsive to our members and the rapid changes in health care. We are helping Minnesota physicians to improve patient health, make Minnesota the best place to practice medicine, and strengthen the profession. We have improved member needs through research, listening sessions, and policy conversations. We have also sought guidance from a wider range of physicians with diverse backgrounds.

MS, FACHE

Challenges: We need to establish and orient a new advisory council for genetic counselors, develop applications and database requirements to manage and track new application and license information, train staff on new procedures, and engage in rule-writing and other implementation processes for the IMLC.

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MD, MBA

Challenges: It is important to be inclusive and listen to all voices. We will continue to be challenged by physician dissatisfaction and burnout and shrinking resources. Staying true to our vision and mission, and having a laser-like focus on the most important initiatives where physicians can make a difference will be crucial for success.

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100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Aaron J. Milbank

Steven Mulder

Jon S. Nielsen

Allison O’Toole

President Metro Urology

President and CEO Hutchinson Health

President and CEO Oakdale ObGyn, a division of Premier ObGyn of Minnesota

CEO MNsure

Changes: We are continuously adapting to the rapidly evolving medical landscape, including the changing payment model that is beginning to favor quality over quantity. It has been an exciting challenge to adapt, while continuing to provide the same high level of care to our patients. This has required a focus on value (quality divided by cost) while continuing to enhance our patients’ experience.

Changes: First, we completed our integration with Hutchinson Medical Center, our local 30-provider multispecialty physician group and adopted a common electronic health record. Our primary care clinics have become certified health care homes and we invested financial and staff resources to develop a truly teambased care model (including our formal collaboration with McLeod County Public Health).

Changes: We advanced our affiliation with Premier ObGyn of Minnesota, an independent divisional merger and have improved quality, access, and satisfaction for our patients. We have advanced gynecological surgical expertise and services for an ever-aging population of women, with a focus on minimally invasive surgical procedures and urogynecology. We’re offering more appointment times and an online patient portal.

Changes: Four years ago MNsure didn’t even exist. We’ve come quite a long way in our short history and are now considered the place for Minnesotans to shop and compare health insurance options, whether that’s for a private plan or one of Minnesota’s public program options.

Challenges: The downward pressure on fee-for-service reimbursement and upward pressure on expenses will continue to require us to find ingenious efficiencies to provide a high level of care. As a large, independent subspecialized practice, we are well positioned to thrive in this changing environment.

Challenges: Solving the financial riddle of moving from volume to value compensation models will be essential. As an independent community health system, we must determine the best corporate model to ensure that we can achieve our mission of “Advancing Health with our Community” into the future.

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MD, FACOG

Challenges: One of our greatest challenges is maintaining our independent obgyn practice model, while continuing to work with most of the large health care systems. Expanding our data analytics capabilities will require a forward-thinking approach that anticipates our patients’ changing needs and use of health care services. It will be a challenge to continue to provide patient-centered and individualized health care in our increasingly “commoditized” environment.

Challenges: We have done a lot in our short time, including helping to lower Minnesota’s uninsured rate to the lowest level in state history. Over the next four years, we will continue to increase health insurance awareness and work to make sure that all Minnesotans have access to quality, affordable coverage.

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Thursday, September 15 ~ 8:15am to 5:00pm Earle Brown Heritage Center Join us to learn how data and measurement impact health equity, cost and quality. Speakers include polar explorer Ann Bancroft; Jean Moody-Williams, Deputy Director of the Center for Clinical Standards and Quality at CMS, on MACRA; and Stephen Nelson, M.D., Director of the Sickle Cell Clinic at Children’s of Minnesota, on race, racism and health inequity. Also featuring panels on adolescent mental health and the importance of specialty care measurement.

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AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Joel V. Oberstar

Vicki Oster

Mark S. Paller

CEO PrairieCare

Pediatrician and President Southdale Pediatric Associates, Ltd.

Senior Associate Dean and Professor of Medicine University of Minnesota Medical School

Changes: PrairieCare and PrairieCare Medical Group together have grown exponentially and now comprise one of the largest psychiatric group practices in Minnesota. Our efforts to provide each individual patient the psychiatric care they truly need have positively impacted patients from all parts of Minnesota and beyond.

Changes: The biggest change our organization made was moving to an electronic medical record system just over two years ago. This was a major change for us, and even though we were well prepared it has taken a long time for us to get back to a comfortable level of functioning.

Changes: The Medical School adopted a strategic plan that re-emphasizes research, education, and clinical excellence. We partnered with the state to develop Medical Discovery Teams focused on solving key health issues. We opened the Clinics and Surgery Center focused on new models of care.

Challenges: We will continue to be challenged moving forward with our EMR, especially as we try to communicate electronically with other EMR systems. The Health Information Exchange is something that needs to be addressed by payers, hospitals, and the government so that a solution can be found!

Challenges: Our faculty must work to balance scholarly work and clinical service when research and academic funding is tight. Only by finding that proper balance can we effectively bring the benefits of an academic health system to all Minnesotans. We also need to develop an integrated academic health system to better serve the state and must continue to work with Fairview and others to accomplish this.

Challenges: Deployment of innovative strategies to reduce morbidity and mortality, while achieving reductions in total cost of care will result in expanded access to mental health care across Minnesota. Partnering with primary care and specialty clinics, schools, and the use of televideo technologies are critical pathways to achieving these goals and more.

Erik Paulsen

MD, MS

Three patients. Who is at risk for diabetes?

U.S. House of Representatives

Changes: I became the newest member of the Ways and Means Health Subcommittee last December. This position gave me the opportunity to successfully turn off the harmful medical device tax for two years, which means more Minnesota jobs and more investment in life-saving innovation. I will continue to push for reforms to Medicare, so that it works better for both doctors and our seniors. Challenges: Partisanship from both sides of the aisle continues to be a hindrance to enacting better policy. Thankfully, I am second in the House for the number of members supporting my legislation and first in the Minnesota House delegation for writing bipartisan bills. By working together, we can overcome this partisanship and get things done.

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MINNESOTA PHYSICIAN AUGUST 2016

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Emily Piper

Rita M. Plourde

Commissioner Minnesota Department of Human Services Changes: We serve more than 1 million Minnesotans a year, through programs such as child care assistance to services that help people stay in their homes as they age. Medical Assistance enrollment has more than doubled in the past decade, while we controlled costs through statewide competitive bidding and payment reform. We have begun to improve the child protection system and continue to do so. Challenges: Improving the mental health system remains a top challenge as we expand community services and address issues in state-run facilities. Long term, our goal is to provide a full continuum of mental health services.

Jon L. Pryor

Brian Rank

CEO Hennepin County Medical Center

Co-Executive Medical Director Park Nicollet HealthPartners Care Group

Changes: We continue to grow our services in family medicine, with the integration of behavioral health and care coordination services. This growth provides us with the opportunity to focus on developing patient-centered services, involving patients and their communities in their health care experience, and growing access to care for all, regardless of their ability to pay.

Changes: The two changes that have improved our ability to advance care are the integration of the Hennepin Faculty Associates physician practice into HCMC and the continued expansion and adoption of Lean methodologies. These efforts promote engagement of staff and allow us to align strategies across the organization improving patient care and business operations.

Challenges: Our challenges today and tomorrow are to be present, and expect and provide the highest standards of care with adequate insurance and financial reimbursement for all services. We also want to welcome all patients, listen to their questions, and assist them in their healing journey while supporting and promoting a healthy community to live in. The challenge remains the goal: Continue to provide access to quality health care to all!

Challenges: With our high percentage of uninsured or under-insured patients, finances will always be a challenge. Moving to a value-based care model, will pose challenges within the reimbursement methodology. We are investing in the infrastructure to align with a population health model, but payment models and financial incentives will need to be developed to support this transition and reward organizations that advance the health of our community.

Changes: Combining HealthPartners and Park Nicollet in 2013 enhanced our ability to support patients, families, and our community by finding new ways to offer high-quality care, reduce costs, and improve health. Together, we’ve focused on improving all we do, particularly around mental health outcomes, health care disparities, children’s health, and chronic illness.

CEO Sawtooth Mountain Clinic, Inc.

MD, MBA

Challenges: Aligning all we do to support our clinicians to provide high-quality, effective care that meets our patients’ needs, whether in person, online, or on the phone. In addition, continuing to build stronger connections across our care group to seamlessly provide the best care and best experience for those we serve.

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AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Megan Remark MHA, MBA

Scott Riddle MBA

Rose Roach

Changes: Our organization has made significant changes related to the ACA. We are working on a demonstration project with the state of Minnesota to form the only safety-net network Accountable Care Organization in the state. We are the only participating Indian Health Service funded in the United States to form an ACO. We remodeled our clinic facilities to reflect the ACO model and improve workflows and care coordination.

President and CEO Regions Hospital

CEO and President Walker Methodist

Changes: Neurological illnesses such as stroke and Alzheimer’s are among the leading causes of death in the U.S. and we’ve made significant investments in this area. In 2014, Regions Hospital became the first Joint Commission-certified comprehensive stroke center in Minnesota. Next year, HealthPartners will open a neuroscience center dedicated to care, rehabilitation, and research. It will be the largest free-standing neuroscience center in the upper Midwest.

Changes: We developed the mission, vision, and values for our organization, which puts the customer first, followed closely by our employees. We want to provide the best place to live for our customers and the best place to work for our employees. Everything we do centers on this objective. We now not only focus on delivering excellent care but also providing superior service.

Changes: For decades, we have promoted effective RN staffing and safe working conditions for both patients and registered nurses in direct patient care, policy, and political arenas. In 2015, we partnered with police officers to create a law that established violence committees, preparedness plans, and de-escalation training. We also worked on system reforms to recognize health care as a human right.

Challenges: It is a challenge to find quality employees to meet the increasing number of older adults who are seeking senior housing and care. The increase in demand is outpacing growth of the labor pool. We are going to have to be creative when recruiting and utilize technology to improve how we care for people.

Challenges: We want a Safe Patient Standard based on a nurse’s professional judgment of acuity, census, and daily needs. We need procedures to keep health care workers and patients safe from violent assaults in hospitals. We want to focus legislative, educational, and organizing efforts by advocating for the creation of a universal publicly financed, privately delivered health care system.

Challenges: By 2025, one in five Americans will be over the age of 65 and we must be prepared to meet the needs of our aging population. Our focus on providing state-of-the-art, patient-centered specialty care in areas of oncology, orthopaedics, and neurosciences will provide a needed community resource to address this challenge.

Patrick M. Rock

Executive Director Minnesota Nurses Association

CEO Indian Health Board of Minneapolis, Inc.

Challenges: The biggest challenge we face is related to funding from the Indian Health Service for the work that we do under the ACA. We also have to comply with ACA technology requirements that will require us to change IT platforms or modify them.

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MINNESOTA PHYSICIAN AUGUST 2016

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Catherine M. Rydell CAE

Executive Director and CEO American Academy of Neurology Changes: We’ve expanded our leadership training programs and developed a clinical data registry currently in pilot phase. We’re working to identify the causes of physician burnout and find well-being tools to combat it. We continue to advocate for resources and assistance to our members for MOC and changes due to Medicare and Medicaid reimbursement. Challenges: We want to expand and monetize our data registry to assure goals are met and patient care is improved. We want to continue to evolve our annual meeting to best meet the needs of all member segments and to build capacity to segment services to our members. We will strive to communicate MACRA implementation to our members in impactful ways.

Sue Schettle

Jeff Schiff

William F. Schnell

Medical Director Minnesota Department of Human Services

Vice President Orthopaedic Associates of Duluth

Changes: We have moved to address quality and efficacy more significantly in our health care strategies. Our foci, on both specific issues (e.g., the ongoing opioid crisis) and more overarching efforts (e.g., accountable care models), align to create real mechanisms to provide greater value to those we serve and the Minnesota community.

Changes: We recently incorporated occupational and physical therapy services into our practice and expanded the range of surgical procedures to include outpatient hip and knee replacement. Additional changes involved technology, such as installing onsite digital X-ray and magnetic imaging equipment. We also implemented a new electronic medical record system.

CEO Twin Cities Medical Society

MD, MBA

Changes: We have deliberately moved away from the traditional role of a county medical society. It became apparent that we had to serve as convener, coordinator, and catalyst to advance public health initiatives such as tobacco policy, environmental health issues, and end-of-life care planning. That switch in focus has successfully increased revenue and more importantly, made a significant impact on the health and well-being of the patients that our members serve. Challenges: I would say that competition is probably one of our biggest challenges. Once you create a successful model there are others that work to replicate it. There are also significant challenges that physicians are facing and joining their medical association is sometimes not top priority.

Challenges: We need to make progress on real sustainable integration of services in health care and between health care and social services. We need to rethink quality measurement and improvement so that the efforts are meaningful to our communities and to our providers. This work must align to decrease disparities in health outcomes.

Challenges: Keeping up with the latest EMR technology is an ongoing challenge, and often the benefits are questionable. In our practice, the time and effort it takes to implement the EMR or the computerized physician order entry (CPOE) systems takes away from patient care. It’s very important to us to spend as much time with patients as possible.

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AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Jim Schowalter

David M. Schultz

Kathleen Sheran

Janice M. Sinclair

President Minnesota Council of Health Plans

Medical Director MAPS Medical Pain Clinics

Minnesota Senate

Former President Minnesota Academy of Ophthalmology

Changes: Council members made a huge commitment to make reform work in Minnesota. We are working more closely than ever before with hospitals, doctors, and the broader community to make sure people get the care they need in new and hopefully more convenient ways.

Changes: In 2014, we merged with a larger pain clinic to become part of a bigger, regional medical practice. This integration allowed us to reduce costs and gain financial stability in a rapidly changing and sometimes unpredictable health care marketplace. The merge created significant changes in our workflows, electronic infrastructure, and corporate culture.

Changes: Over the past four years, we have advanced numerous reforms in the area of health care. The largest change has been the implementation of the Affordable Care Act at the state level. We also passed a bill removing barriers for advanced practice registered nurses, giving more Minnesotans access to advanced health care.

Changes: The Minnesota Academy of Ophthalmology has had to become a stronger voice to advocate for and protect our patientsâ&#x20AC;&#x2122; access to high quality eye care.

Challenges: Declining reimbursement and restrictions in patient access to interventional pain procedures have reduced revenue at the same time that costs have increased. Computerized automation of systems increases efficiency, but maintaining a compassionate connection to our patients while using computers is challenging. Our challenge is to reduce the abuse and diversion of prescription opioids, while safely providing opioid medications to chronic pain patients who truly need them.

Challenges: As with all changes, the challenges ahead will be to keep them in place and continue to improve upon them. While we are pleased with the implementation of the ACA, there are certainly changes we can make to improve delivery and cost of care.

MPP

Challenges: We need to figure out a better way to deal with increasing medical expenses. Health insurance is so expensive because care is so expensive. Unless we come together and do something to slow down galloping prescription drugs and other medical expenses, none of us will be able to afford the care that we need.

MINNESOTA PHYSICIAN AUGUST 2016

RN, MS, APRN

Challenges: It will continue to be a challenge to ensure the delivery of the best eye care as we strive to improve outcomes, reduce cost, and pursue technological innovation all at the same time.

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Cindy Firkins Smith

Deborah L. Smith-Wright

John Solheim

Tony Spector

President and CEO ACMC Health

Director of Pediatrics Shriners Hospitals for Children –Twin Cities

CEO Cuyuna Regional Medical Center

Executive Director Emergency Medical Services Regulatory Board

Changes: The most visible change is the transformation of our leadership team. Leaders who had served our organization for 10 to 15 years either retired or transitioned to new positions. In the last year we’ve welcomed a new chief administrative officer, CMO, medical director of quality and innovation, and I stepped into my role in January 2016.

Changes: Until five years ago, all care was provided free of charge. When we began to bill insurance, our mission changed to assisting families with out-of-pocket expenses that caused them financial hardship. The billing change necessitated multiple changes in resources, manpower, and clinical services. We continue to provide specialty pediatric orthopaedic care regardless of ability to pay.

Changes: The biggest change has been the explosive growth since we integrated with our medical staff. We have recruited more physicians and built a $16 million renovation that includes a new OR suite, PACU, and outpatient area. Our new EMR and financial reporting systems gave us one platform between the hospital and clinic, which has been beneficial to our patients.

Changes: This agency has become more transparent, collaborative, and mission-focused. The Board has been more engaged in establishing policies that address emerging issues that impact the public’s health and safety generally and the EMS system specifically. Staff have operationalized and executed these policies with integrity, with responsibility, and with professionalism that includes timely responses to our clients, our stakeholders, and our partners.

Challenges: We have ambitious goals to transform health care delivery in rural Minnesota, while keeping patients first. We must transition to a system where we are reimbursed for the value we deliver. We will be challenged by geographic, age, economic, social, and racial diversity when we design systems for our communities. Our biggest challenge will be to recruit talented and committed providers and support staff.

Challenges: As an independent hospital system, we anticipate facing an increasingly competitive environment where hospitals and clinics are merging and forever changing the medical landscape. We anticipate in order to compete as a standalone specialty center, we will need to embrace the use of technology such as telemedicine and other programs to provide our care in an affordable, efficient, and accessible manner.

MA, FACHE

MA, JD

Challenges: The biggest challenge in the future is to remain an independent medical center as health care consolidation continues. We are converting to a 501-(c)3, which will give us more flexibility in a competitive environment. We need to recruit a quality workforce to meet the growing demand of medical services and manage the infrastructure needed to ensure quality outcomes while moving toward population health management.

Challenges: As new and emergent diseases and hazards pose greater threats to the public, this agency must be proactive in establishing standards that serve the public and protect the EMS professional. In addition, we must be at the forefront of creating guidelines and benchmarks for those EMS provider categories created to address gaps in the health care system.

AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Keith Stewart

L. Read Sulik

Allison Suttle

Lori Swanson

Carlson and Nelson Endowed Director Mayo Clinic Center for Individualized Medicine

Chief Integration Officer, PrairieCare Executive Director, PrairieCare Institute

Senior VP and Chief Medical Officer Sanford Health

Minnesota Attorney General

Changes: For every patient to benefit from precision medicine the Mayo Clinic Center for Individualized Medicine continues to make significant advances to employ genomic sequencing to reach the correct diagnosis faster, provider safer drug prescribing, and identify novel treatments for cancer. Transforming how we deliver care to our patients, results in better-informed care and outcomes, reduced side effects, earlier interventions, and increased prevention and prediction of disease.

Changes: We opened a new 50-bed state-of-the-art child and adolescent psychiatric hospital in Brooklyn Park and the PrairieCare Institute, our center for innovation, training, and research. The Institute houses the “hub” for our Integrated Health and Wellness Clinics (IHWCs), “a clinic in a clinic” that are now in six different primary care clinic sites.

Changes: We have worked to prepare our organization for value-based health care. The delivery model for primary care needed redesigning to better meet the needs of patients. For example, we’ve implemented options for virtual care and created a teambased medical home. Additionally, our integrated structure has allowed Sanford to standardize care delivery to remove unnecessary variation and improve quality.

Changes: This is a period of significant change in our health care system. As insurance costs rise, more patients are shifted to high deductible health plans. The problem is that many families can’t afford these high deductibles. We have also seen patients impacted by increases in prescription drug costs.

MB, ChB, MBA

Challenges: To revolutionize how we improve and treat disease through precision medicine, we need to rapidly modernize the treatments and diagnostics. We also need to improve and maintain efficiency, productivity, and quality to provide high quality, affordable outcomes at a low cost. This requires intentional efforts to innovate to determine if new methods produce better results.

MD, FAAP, DFAACAP

Challenges: The biggest challenges will likely be keeping up with the growing demands for our newest area of innovation, the Integrated Health and Wellness Clinics. We also want to bring these Clinics into companies that are self-insured. The recruitment, training, and ongoing development of the right people committed to this exciting innovative work is already a challenge we are attempting to solve proactively.

MD, MBA

Challenges: The new model of health care demands adaptability. Sanford will need to maintain a workforce and have mechanisms in place to incentivize value-based health care. Technology is an extraordinary tool, but it’s important to keep medicine a personal and connected experience. It’s critical that we leverage the valuable data collected to impact outcomes.

Challenges: Our state faces many challenges: Competition is the best regulator of rates and services, and I’m concerned about consolidation. Rising health insurance costs continue to squeeze employers and individuals. The system must ensure that financial incentives in ACOs don’t result in undisclosed rationing. The system also lacks capacity and resources to properly serve the mentally ill.

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MINNESOTA PHYSICIAN AUGUST 2016

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Paula M. Termuhlen

Paul Thissen

Jon Thomas

Regional Campus Dean University of Minnesota Medical School–Duluth Campus

Minnesota House of Representatives

Minnesota Commissioner Interstate Medical Licensure Compact Commission

Changes: The biggest change for our campus has been the recruitment of new leadership with fresh ideas to reinvigorate our campus mission to serve rural and Native American communities through research and medical education. Education and health care are becoming increasingly interprofessional. We have embraced this goal with enthusiasm.

Changes: The biggest change we’ve seen is the proliferation of new models of care delivery and risk assignment. Minnesota is a creative, exciting place to be as someone who thinks hard about how to fit new ideas into outdated regulatory boxes.

Changes: As chair of the Federation of State Medical Boards in 2013–2014, I shepherded development of the Interstate Medical Licensure Compact Commission legislation. This set forth the idea of a compact, which is an agreement between states that would facilitate and expedite medical licensure. The goal is that once a qualified physician has a license in one of the compact states, he or she would be able to become licensed in any or all of the other compact states within days to weeks. This will facilitate licensure, mobility of a qualified physician workforce, and telemedicine.

Challenges: While Minnesota is one of the healthiest states, it also has some of the largest health disparities, particularly in its Native American and rural communities. We hope to promote health equity through research and practice. Funding for research of all types is challenging and yet essential to ensure better understanding of disease.

Challenges: The biggest challenges we face as a state government and in the private/non-profit sector of health care is moving away from a discussion of health insurance reform (which is where the conversation has been) and into true health care reform. How do we deliver high-quality health care services to everyone as inexpensively as possible and how do we make the tremendous amount of health care data work for us while balancing privacy concerns?

David Tilford

MD, MBA

President and CEO Medica

Challenges: The biggest challenges are political barriers and the erroneous belief that this is somehow related to MOC.

Changes: The ACA has impacted nearly every segment of our business. Changes to the individual market have resulted in new opportunities, but great challenges. Our Medicaid business has grown significantly due to how the state awards that business. We have begun to make changes in our Medicare business as we prepare for the sunset of the Medicare Advantage program. Challenges: Affordable health care is our biggest challenge. Advancements in medical technology and treatment are exciting. At the same time, we need to use health care dollars wisely and efficiently. The individual market continues to be a challenge. Insurer losses on ACA plans nationwide are expected to run into the billions. It will take time for pricing and medical expenses to get in line.

AUGUST 2016 MINNESOTA PHYSICIAN

100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Christopher Tillotson

Ensor E. Transfeldt

Misty Tu

Jeffrey L. Tucker

President and Musculoskeletal Radiologist Consulting Radiologists, Ltd.

Spine Surgeon, Twin Cities Spine Center Medical Director, Allina Spine Program

Senior Medical Director for Psychiatry and Behavioral Health Blue Cross and Blue Shield of Minnesota

President and CEO Integrity Health Network

Changes: Our biggest change has been converting to a completely physician-led practice. In the past, we had utilized a non-physician CEO. Our reasoning is that only through physician leadership could the group fully realize its potential and be in a position to respond to the rapidly changing health care environment in the upper Midwest. Also, the high degree of physician involvement promotes cohesion and more fully leverages our intrinsic talents.

Changes: We have moved from a boutique spine surgery practice toward an integrated, comprehensive spine practice with other providers and health systems. The partnership with Allina has allowed us to focus on patient-centric care. Measurement of outcomes and costs makes it possible to eliminate waste and encourage continuous quality improvement, while reducing costs.

Changes: We are deeply committed to advancing health equity. We are proud to have made a healthy difference over the past few years by increasing access to healthy food and improving conditions where Minnesotans live, work, and play. Finally, behavioral health is a growing area where we need to continue asking the right questions in order to make progress.

Changes: We launched a Medicare Shared Savings Program ACO and a state of Minnesota Medicaid ACO through the Integrated Partnership Program. We received grant dollars from the State of Minnesota State Improvement Model to help us develop and implement a health information exchange. Additional funding allowed us to develop a regional accountable community for health (ACH).

Challenges: The biggest challenge is to pay for services, without sacrificing quality. We don’t have enough mental health care inpatient beds or a robust enough outpatient and safety network. Funding is available, but that won’t help if we aren’t offering the right services at the right time. These are some of our most vulnerable members, and they need us to do the best job we can.

Challenges: A rapidly evolving health care market taxes our clinics’ ability to respond and apply limited resources. We need to find ways to make each initiative sustainable and keep partners at the table (counties, hospitals and clinics). Increasing government regulation and decreasing reimbursement and resources has accelerated consolidation in the Minnesota marketplace and caused the loss of independent clinics in large numbers.

Challenges: We are a large independent physician group and wish to remain so. There is a fair amount of uncertainty as to how to maintain a successful practice as we move further into the ACO era. For example, what is the best approach, configuration and size to navigate in this rapidly changing environment?

Challenges: The biggest challenges these changes face are: Providers across the continuum must embrace the changes needed. An integrated network must be created and maintained throughout a vast population and geographic area. Consensus needs to be achieved among providers regarding care pathways.

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100 INFLUENTIAL MINNESOTA HEALTH CARE LEADERS

Paul E. Van Gorp

Tim Weir

Penny Wheeler

Cody Wiberg

Family Physician CentraCare Health–Long Prairie

CEO Olmsted Medical Center

President and CEO Allina Health

Executive Director Minnesota Board of Pharmacy

Changes: From my perspective as a small-town rural family physician, there have been two major changes for us in the past few years: our teambased care pilot project to improve the care of those with chronic disease, and our drive to build a new medical campus to serve our community.

Changes: Many of our recent changes relate to our continued patient engagement initiatives, care redesign efforts, and market share growth strategies. Employee and provider recruitment and retention continue to be critical for our ongoing success.

Changes: We increased our focus on supporting health in addition to responding to illness. We also invested in community collaborations (even with competitors!), which improved the community’s health, while improving affordability and decreasing unnecessary duplication of services in our community. We worked with HealthPartners on the ACO-like NW Alliance; Mother-Baby partnered with Children’s; we merged with Courage to create Courage-Kenny; and worked with the state on Integrated Health Partnerships.

Changes: The Board has worked on legislation to tighten the regulation of compounding pharmacies, allow pharmacists to administer vaccines to children 13 years of age or older, improve our Prescription Monitoring Program (PMP), and allow pharmacies to collect unwanted drugs for disposal.

MA, MBA

Challenges: We need to put a succession plan in place to ensure continuity of quality care. We currently cover the bases with a relatively young group of advanced practice providers, but our physician leaders are nearing retirement and must be replaced and expanded to allow comprehensive care to continue. Furthermore, growth will be necessary to cover the cost of the new facility.

Challenges: Ongoing declining reimbursement, coupled with required capital and IT obligations, will continue to challenge our organization. Additionally, change management skill sets that are required to be successful in a rapidly changing health care delivery system, will be critical. We will see challenges related to employee satisfaction and retention as our patients expect their care to be available in a variety of delivery models.

PharmD, MS, RPh

Challenges: Declining revenue will have us reduce costs, while we invest in new models of care (not yet paid for) that support the health of our community (such as mental health resources, care management, data/information systems to improve care, etc.) We’ll also shift our thinking to value-based services for volume-based successes.

Challenges: We continue to have problems with compounding pharmacies that are not fully complying with the laws. It has been difficult to get PMP legislation passed, due to concerns about data privacy. Prescription drug abuse has become an epidemic, making it a challenging issue to respond to, but the Board is working with many other state agencies to address it.

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RISK MANAGEMENT

he provider/patient relationship is a unique bond. It involves commitments on professional, ethical, and legal levels. Also, while a patient can decide to sever the bond at any time for any reason, a provider is a bit more restricted in this regard. According to Opinion 8.115 from the American Medical Association’s Code of Medical Ethics: Physicians have an obligation to support continuity of care for their patients. While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured.

Ending an established provider/patient relationship without reasonable notice and without reasonable opportunity

Terminating the provider/patient relationship Avoiding an allegation of abandonment By Ginny Adams, RN, BSN, MPH, CPHRM

for the patient to arrange for medical care can lead to an allegation of abandonment. Abandonment is a tort, similar to negligence, defined as the termination of a professional relationship between provider and patient at an unreasonable time and without giving the patient

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the chance to find an equally qualified replacement. In order for a patient to bring a medical professional liability lawsuit, the patient must have suffered some harm from the abandonment. The plaintiff must prove that the provider ended the relationship at a critical stage of the patient’s treatment without good reason or sufficient notice to allow the patient to find another provider, and that the patient was injured as a result. Providers encounter a myriad of situations that may trigger a need to terminate the provider/patient relationship. Examples of such situations include inability to agree on the patient’s plan of care, failure of the patient to pay his or her bills, verbal abuse, physical threats or harm, personal conflicts, or failure to comply with an established care agreement, such as a pain contract. In fact, providers can terminate a provider/patient relationship for virtually any non-discriminatory reason, provided they give the patient proper notice and do not withdraw from caring for a patient who is in the midst of a medical crisis. When termination of an established relationship becomes necessary, certain steps should be followed to help avoid an allegation of abandonment. These steps include, 1) establishing procedures for terminating relationships, 2) determining if a relationship may be terminated, 3) notifying the

patient in writing, 4) continuing to treat the patient during the notice period, and 5) avoiding re-establishing a relationship. The risk management recommendations for each of these steps follow below. Establish procedures for terminating relationships • Terminating the provider/ patient relationship should be undertaken only after serious attempts have been made to clarify and understand the expectations and concerns of all involved parties. • The responsibility for ending the relationship rests with the provider and should not be delegated to an office staff member. • Develop a written policy and procedures for discharging patients from the practice. • Draft a standard termination letter as a sample. Determine if the relationship can be terminated • Evaluate each relationship on a case-by-case basis. Consider the patient’s underlying state of health and the severity of the signs and symptoms of the patient’s disease process, the stage of the current course of treatment, and the availability of comparable medical care or treatment. • Ensure that the patient is not in a physical or emotional crisis. For example, a psychiatrist may not terminate a patient who is suicidal or in a state of extreme agitation or depression. Continue to treat patients who have an acute medical condition, delaying termination until the acute condition has been resolved. • Use extreme caution when circumstances, such as provider disability, require that a relationship be terminated with a pregnant patient who is past 20 weeks gestation or with an acutely

ill behavioral health patient. Help the patient find a new provider. Contact the new provider to verbally handoff the patient, provide medical records, and confirm that an appointment is scheduled. Document the verbal hand-off in the medical record. • Assess the situation to determine if there are any underlying factors for the patient’s behavior. For example, if the reason for termination is the failure to pay a bill, contact the patient to determine why the bill has not been paid. The patient may be unhappy with the care or there may be extenuating circumstances, such as the loss of a job. Terminating the relationship may lead to further anger and even prompt the patient to sue. Demonstrating care and concern may help to prevent a conflict with the patient from escalating. • Do not terminate a relationship because of gender, race, religion, or sexual preference. Furthermore, patients covered under the Americans with Disabilities Act (ADA) may only be terminated for reasons similar to that of a non-disabled patient, not because of additional costs (e.g., providing an interpreter for a deaf patient). • Check the provisions of any contract you have signed with the patient’s health plan to ensure compliance, as third party payers may also have their own policies and procedures that need to be followed when a professional relationship is terminated. Notify the patient in writing • Send a letter of termination via certified mail to the patient’s home address, return receipt requested. Put a copy of the letter and the postal receipt in the patient’s medical record

and write a final entry. If the patient refuses to accept the certified letter, file the returned letter and envelope

with the provider signing the letter or with the entire practice. Name all of the group members or the entire

Terminating a relationship with a patient is never a desired outcome.

in the medical record. Mail a duplicate letter in a plain envelope with no return address. • The reason for termination may or may not be included in the letter. Omitting a reason, however, may trigger a phone call or letter from the patient and potentially escalate the situation. Under certain circumstances, it is acceptable to use the catchall phrase “inability to achieve or maintain rapport” or to state “The therapeutic provider-patient relationship no longer exists.” • Clearly state the date upon which the termination of the professional relationship will become effective. • If the patient requires ongoing care, make sure that this is clearly conveyed to the patient, along with the specific risks of failing to receive appropriate care. • The provider should not provide the patient with a specific name of another provider except in extreme situations. The patient should be provided with a provider referral source, such as the patient’s health plan or the local medical society. • Determine exactly with whom the professional relationship is being terminated when the provider is in a group practice. Specify whether the relationship is being terminated only

practice if the relationship is being terminated with the practice as a whole. Continue to treat the patient during the notice period • Continue to provide care for the patient for a reasonable period of time, generally 30 days, while the patient makes arrangements to

obtain the services of another provider. • Make sure that you clearly explain this in the termination letter. Release a copy of the medical records to the new provider • Offer to transfer records to the new provider upon receipt of a signed authorization to do so. Include an authorization to release records with the termination letter. Do not relinquish the original medical records to the patient or to the subsequent provider. • The usual practice is for the withdrawing provider to furnish a copy of the patient’s chart to another

Terminating the provider/patient relationship to page 44

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PROFESSIONAL UPDATE: ONCOLOGY

nderstandably, colorectal cancer remains an uncomfortable topic to discuss, yet awareness and access to preventive services are critical to reducing the burden of the nation’s second leading cancer killer. While Minnesota has made significant progress over the past decade, with screening rates among the nation’s best, unfortunately nearly 30 percent of Minnesotans over the age of 50 have never been screened. There are many reasons for these low rates including patient fear, however data suggests that recommendations for screening by a patient’s primary care physician have the greatest impact. Nationally the incidence of colorectal cancer has decreased in part due to screening, yet over 145,000 new cases and 40,000 deaths were attributed to this disease in 2015. In Minnesota, the incidence and mortality rates for colorectal cancer parallel

Improving outcomes for colorectal cancer Prevention and detection By M.P. Spencer, MD, FACS, FASCRS

the national data published by the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute demonstrating a steady decline for the past 20 years. Much of the credit for our success locally should go to a collaborative effort by the American Cancer Society, Minnesota Department of Health, and a coalition of smaller organizations like our group, that make up the Minnesota Cancer Alliance. These groups partnered to formulate a more

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MINNESOTA PHYSICIAN AUGUST 2016

comprehensive statewide cancer plan. The present iteration began in 2011 and has effectively linked existing initiatives and leveraged critical resources in an attempt to optimize the outcomes focusing on five broad goals: • Cancer prevention • Cancer detection • Facilitating appropriate care • Optimizing quality of life • Eliminating disparities One could devote the entire article to any of these issues; however, I would suggest for most physicians our greatest opportunity to improve colorectal cancer screening is to focus on prevention and detection, (i.e., optimum implementation of screening).

• Double-contrast barium enema every five years • Guaiac-based FOBT yearly • Fecal immunochemical test (FIT) yearly • Stool DNA (Cologuard) every three years While we continue to debate which tests should be utilized, all tests have demonstrated a positive impact on reducing the incidence for colorectal cancer when used appropriately. Most recently, Cologuard has gained more attention as it is a nonintrusive tool that requires no bowel prep. The test relies on DNA, not blood, shed into stool and early trials have demonstrated superiority to the fecal immunochemical test (FIT) in detecting cancer and advanced adenomas. Cologuard has been approved by the FDA and Centers for Medicare & Medicaid Services, yet has not been endorsed by the United States Preventive Services Task Force because of concerns regarding lack of long-term evidence supporting this method. It is important to note that in order for these tests to be effective, it is imperative that patients comply with the recommended intervals. Additionally, it should be

Nearly 30 percent of Minnesotans over the age of 50 have never been screened. Screening guidelines It is clear that screening has reduced the mortality associated with colorectal cancer, which is why the American Cancer Society is promoting a campaign to improve screening rates to 80 percent by 2018. In 2008, a U.S. multi-society taskforce on colorectal cancer proposed the following for all average risk individuals, (those with no family history of colorectal cancer, personal history of inflammatory bowel disease, and no GI symptoms) over the age of 50: • Colonoscopy every 10 years • CT colonography every five years • Flexible sigmoidoscopy every five years

clear to the patient that should any of the tests reveal an abnormal finding then a colonoscopy is warranted. The recommendation for average risk-patients remains fairly straightforward; however identifying high risk individuals becomes a more complicated task. Many physicians are reluctant to address risk status or genetic predisposition, as they frequently lack sufficient data to make a recommendation. Sadly, while the incidence of colorectal cancer is declining in those over 50 years of age, the incidence rate for people under age 50 has increased steadily over the past decade, emphasizing the importance of risk assessment

and implementing testing for those with increased risk. With enhanced understanding of the molecular and genetic path ways of colorectal cancer, including chromosomal instability, microsatellite instability, and hypermethylation, we have been able to tailor our approach to screening and surveillance. A personal history of adenomatous polyps or colorectal cancer increases the risk for metachronous cancer. First degree relatives of patients with colorectal cancer have a two to threefold increase for colorectal cancer and adenomatous polyps. Finally, first degree family members of patients with adenomatous polyps are also at increased risk for colorectal cancer, particularly when polyps are diagnosed before age 60. Patients at the highest risk for colorectal cancer are those with inherited syndromes including familial adenomatous polyposis (FAP); hereditary nonpolyposis colorectal cancer (HNPCC); and MYH-associated polyposis (MAP). Here are the screening guidelines for individuals with increased risk based on family history: • With a family history of colorectal cancer or adenomatous polyps in first degree relatives before age 60 or two or more first degree relatives at any age, colonoscopy should begin at age 40. Here are the screening guidelines for individuals at high risk based on genetics: • FAP (familial adenomatous polyposis): Colonoscopy at age 10–12 • HNPCC (hereditary non-polyposis colorectal cancer): Colonoscopy at age 20–25 • Inflammatory bowel disease: Colonoscopy yearly starting 10 years after onset of colitis Screening cessation The U.S. Preventive Services Task Force recommends screening up to the age of 75. Screening may be considered

in otherwise healthy individuals after age 75 if they have not previously been screened. Many health systems and

In an attempt to assure quality care, the American Gastroenterological Association (AGA) and American Society

Recommendations for screening by a patient’s primary care physician [have] the greatest impact.

even larger private groups have implemented care coordinators to assist physicians in identifying a patient’s risk status. In our system, the care coordinators are physician assistants or nurse practitioners, which makes it easier to help with ordering tests and consults. One of the most common ways to utilize care coordinators and identify high-risk patients is through pre-visit planning for new patients or annual physicals. The care coordinator can follow risk and genetic assessment tools, track down prior tests, confirm personal and family history, and provide the physician with a recommendation to present to the patient at the time of the visit. With electronic medical records these care paths can be hardwired, without too much difficulty, and provide valuable timesavings in the primary care setting. Moreover, the care pathways are useful in assuring compliance with screening recommendations and can provide significant savings to the health care system by integrating appropriate surveillance or additional evaluations as part of the care pathway. We have found care coordinators extremely effective in facilitating comprehensive staging, multidisciplinary evaluations, perioperative care, and assuring compliance with long-term care and testing. As a bonus, our patients have reported greater satisfaction when a care coordinator is involved. Finally, good outcomes are contingent on the quality of the exam, pathologic assessment, appropriate data collection, and surveillance recommendations.

of Colon and Rectal Surgeons (ASCRS) have implemented new training guidelines and strongly encouraged ongoing quality assessment for their fellows. In the Twin Cities, both Minnesota Gastroenterology and Colon and Rectal Surgery Associates has invested time and resources to carefully track this data. Both groups meet and/or exceed regional and national benchmarks for polyp detection, withdrawal times, completion rates, and

other parameters reported. We are working with many of our larger health care systems to assure compliance with these standards, improve documentation, and provide appropriate surveillance exams. Conclusion Colorectal cancer is the second leading cause of cancer death in the United States. The disease is unique in that the identification and removal of polyps can prevent most cancers. Increasing awareness of the preventable nature of this disease and increased utilization of screening tools does save lives. I hope you’ll join me in the effort to improve screening rates to 80 percent by 2018.

M.P. Spencer, MD, FACS, FASCRS,

is president and CEO of Colon and Rectal Surgery Associates, LLC.

with a Mankato Clinic Career Established in 1916, physician-owned and led Mankato Clinic is 100 years strong and seeking Family Physicians for outpatient-only practices. Over 50% of our physicians are involved in leadership positions and make decisions for our group. Full-time is 32 patient contact hours and 4 hours of administrative time per week. Four-day work week available. Clinic hours are Monday-Friday, 8 a.m.-5 p.m. OB is optional. Call is telephone triage, 1:17, supported by a 24/7 Nurse Health Line. Market-competitive guaranteed starting salary, followed by RVU production pay plan. Benefits include 35 vacation / CME Days annually + six holidays, $6,600 annual CME business allowance and a generous profit-sharing 401(k) plan. We’re just over an hour south of the Mall of America and MSP International Airport. If you would like to learn more about building a Thriving practice, contact:

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

Apply online at www.mankatoclinic.com AUGUST 2016 MINNESOTA PHYSICIAN

Avoid re-establishing the relationship • Inform all practice staff members that a termination letter has been sent. If a new

Terminating the provider/patient relationship from page 41

provider at no charge. Some providers charge a modest fee if the copy is made only for the patient, but most absorb this cost to avoid ending the relationship on a negative note. • Under no circumstances should a provider who is withdrawing from care refuse to provide a subsequent treating provider with a copy of the medical record because the patient has not paid for medical services. Such withholding of the medical records and/ or medical information exposes the provider to liability should the patient suffer because another provider did not have access to important information.

summoned to the emergency department (ED), the provider cannot refuse to see the patient. The provider can, however, limit his or

The responsibility for ending the relationship rests with the provider.

appointment is made after the termination effective date, it may arguably re-establish the relationship. • A patient who has been discharged from a provider’s practice must still have access to care in the emergency department. If the provider who discharged the patient is on-call and

her responsibilities to treating the patient in the ED and, depending on the hospital’s medical staff bylaws, may not have to see the patient in follow-up, but may refer the patient to another provider. When the on-call provider makes a referral to another doctor for follow-up or finds another provider

to admit the patient to the hospital, the arrangements should be clearly documented in the ED medical record and made clear in writing to the patient. Conclusion Terminating a relationship with a patient is never a desired outcome and all efforts should be made to work with the patient to provide ongoing care. When a termination must occur, all efforts should be made to manage the process in the most cordial manner possible. Ginny Adams, RN, BSN, MPH, CPHRM, is a senior risk consultant for Coverys, a medical professional liability insurance company. She has a background in critical care nursing, nursing administration, performance improvement, regulatory compliance, and risk management.

Olmsted Medical Center, a 220-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth. Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere. The Rochester community provides numerous cultural, educational, and recreational opportunities. Olmsted Medical Center offers a competitive salary and comprehensive benefit package.

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www.olmstedmedicalcenter.org 44

MINNESOTA PHYSICIAN AUGUST 2016

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AUGUST 2016 MINNESOTA PHYSICIAN

Generic antiepileptic drug substitution from cover

Once the FDA allows generic versions of a branded drug on the market, multiple different manufacturers will enter the market with generic products. For example, in the case of lamotrigine, since 2009 there have been 15 different manufacturers of generic lamotrigine. With time and competition in the market, the number of generic products for a single drug typically decreases. However, the safety of generic medications in epilepsy has been questioned by physicians and patients alike because of many reports of loss of seizure control or unexpected adverse effects after generic switches, as we will discuss. Studies concerning the risk of generic switches were primarily small—uncontrolled series, physician surveys, and retrospective database reviews. Furthermore, studies were not

consistent because several large database analyses came to the opposite conclusion that generic switches were not associated with problems. The position of the Food and Drug Administration (FDA) has always been that the rigorous testing it requires

Lower medication costs may lead to improved medication adherence resulting in improved seizure control.

of generic products before coming to market is adequate and there have been no rigorous studies documenting problems that controlled for all possible variables. What then is a clinician to do? Thankfully, a new series of rigorous, prospective studies have provided reassuring data that generic and brand antiepileptic drugs (AED) are truly equivalent.

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Seizure control The stakes in this controversy are high. Seizure control has an enormous impact on epilepsy patients allowing for maintenance of a livelihood without driving or work restrictions, avoidance of seizure-related

injury, and avoidance of extra use of health care resources (outpatient and hospital visits). The evolving debate around generic versus brand AEDs focuses on efficacy as well as adverse effects and toxicity with generics. Due to the narrow therapeutic window of AEDs, small changes in serum concentration can result in loss of seizure control or toxicity. Many of the initial concerns regarding generic antiepileptic drugs originated from retrospective observational studies and case series, as well as anecdotes from patients and physicians. A retrospective case series of 50 patients noted physician-reported breakthrough seizures following substitution of brand to generic AEDs (Berg et al., Neurology, 2008). This study also reported that blood levels were lower in 21 of 26 patients on the generic, although there were no controls on timing of levels and adherence. A patient survey noted out of 251 patients that 10.8 percent experienced a breakthrough seizure or toxicity attributable to the change to a generic substitute (Crawford et al, Seizure, 1996). Switchback rates “Switchbacks” as a measurement suggesting adverse clinical consequences of generic drugs has been used in several studies; that is, once a patient was switched to a generic product, what was the rate that those same patients were switched back to a brand product. A study in Canada was interesting because thousands of epilepsy patients receiving

the AED lamotrigine switched over to generics at one time due to a government mandate. This study concluded that there were higher switchback rates among AEDs as a class compared to other drugs including serotonin reuptake inhibitors and statins (Andermann et al., Epilepsia, 2007). This study notes that to switch back to brand, required extra physician documentation of adverse reaction or support of medical necessity due to Canadian laws. The cause of the switchback was not known. The study also noted a statistically significant increase in dosage from the brand product to the generic product suggesting that the bioavailability was decreased. Another study of 671 lamotrigine patients identified switchback rates for antiepileptic drugs to be 20.8–44.1 percent compared to non-AEDs at 7.7–9.1 percent (LeLorier et al., Neurology, 2008). This study again noted higher dosing regimens for patients on generic drugs and also concluded an increase in outpatient visits and longer inpatient length of stay for those taking generics. Both these studies were limited due to the use of claims data analysis, which does not identify clinical information on reasons for switchbacks, compliance, and disease severity. As a result of these reports, there was a consensus among the epilepsy community to be aware of the potential risks of switching from brand to generic AEDs. The American Academy of Neurology (AAN) released a position statement in 2006 stating that, “The AAN opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician’s approval” and without prior consent of the physician and patient. FDA requires bioequivalence studies The FDA approves generics when the generic product contains the identical amount of active ingredient as the brand Generic antiepileptic drug substitution to page 48

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Generic antiepileptic drug substitution from page 46

product and passes studies of bioequivalence to the brand product. Bioequivalence studies involve small groups of normal volunteers (typically 24–36) who are studied intensively after single doses of both the brand and the generic products of the drug being studied are taken. Bioequivalence is determined on the basis of maximum serum concentration (Cmax) and the area under concentration time curve (AUC), which is a measure of total drug absorption. For a generic drug to be considered bioequivalent, the 90 percent confidence interval of the ratio of the AUC and Cmax for brand to generic must fall within a range of 80–125 percent. Some argue that this range is problematic for AEDs as most have a narrow therapeutic range where small alterations in concentration could result in loss of effect, or

conversely, toxicity. Therefore, a change from a low-end generic to a high end, or vice versa, could cause adverse clinical effects. The FDA has done several reviews of drugs and notes that the mean variation of generic is 4.35 percent for Cmax and 3.56 percent for AUC, well within the maximum range (Davit, Annals of Pharmacotherapy, 2009). Criticisms of the FDA methodology include that these bioequivalence data for generics are carried out on healthy individuals, using single doses. Similar studies in epilepsy patients with chronic dosing, while switching between two generic products at the extremes of the allowable range could provide different results. New rigorous pharmacokinetic studies To answer these concerns, the FDA funded a series of rigorous pharmacokinetic studies in people with epilepsy with generic to generic switches and rigorous

Cuyuna Regional Medical Center is seeking two full-time Family Medicine physicians for its Crosby Clinic. Located in the heart of the Cuyuna Lakes Area, CRMC’s Crosby clinic has recruited 22 New and dedicated, quality physicians & APC’s in the last 2 ½ years that, along with the required up-to-date technology, have developed CRMC into a regional resource for advanced diagnostic and therapeutic healthcare services. Our Family Medicine opportunity: • MD or DO • Board Certified/Eligble in Family Medicine, Internal Medicine or IM/Peds • Full-time position equaling 36 patient contact hours per week • Work 4.5 days a week. • 1 in 11 Peds call. (Majority of calls handled by phone consultation) • Practice supported by 14 FM colleagues, APC’s and over 35 multi-specialty physicians • Subspecialty providers—Internal Medicine, OB/GYN, Orthopedics, Urology, Surgery, Oncology, Pain Management and more • Competitive comp package, generous signing bonus, relocation and full benefits • New Residients are encouraged to apply A physician-led organization, CRMC has grown by more than 40 percent in the past three years and is proudly offering some procedures that are not done elsewhere in the nation. The Medical Center’s unique brand of personalized care is characterized by a record of sustained strength and steady growth reflected by an ever-increasing range of services offered.

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MINNESOTA PHYSICIAN AUGUST 2016

adherence measures. A randomized, double-blind, multiple dose, double crossover, steadystate bioequivalence study of 34 patients taking lamotrigine was reported in 2015 (Ting et al., Epilepsia, 2015). Patients were switched between Lamictal and generic lamotrigine (manufactured by Teva) in a two-week period, and at the end of the two-week period, a 12-hour pharmacokinetic sampling was performed to measure Cmax and AUC. The 90 percent confidence intervals of the mean for steadystate AUC, Cmax, and Cmin were 97.2–101.6 percent, 98.8–104.5 percent, and 93.4–101.0 percent, respectively, well within the FDA bioequivalence standards. Secondary outcomes found seizure exacerbations and tolerability in a few patients with one patient who had reported increased focal motor seizures but with pharmacokinetic parameters nearly identical when changed from brand to generic. The authors stated that they had confirmed the “soundness of FDA bioequivalence standards” in brittle epilepsy patients over chronic steady-state dosing. Testing generics in people with epilepsy in real-world conditions A multicenter group, (Equivalence Among Generic Antiepileptic Drugs-EQUIGEN group) confirmed through two studies that FDA bioequivalence standards are appropriate. The first study tested the two most disparate lamotrigine generic products available on market (Privitera, The Lancet Neurology, 2016). The two disparate generics were determined by data provided to the FDA by the generic manufacturers along with laboratory testing of all available generic lamotrigine products. This study analyzed 33 epilepsy patients who were already taking lamotrigine with four study periods of 14 days each. Adherence was rigorously tested via tablet counts, medication diaries, and electronic monitoring of medication bottle openings. The 90 percent confidence intervals of the ratios of dose-normalized AUC and Cmax for the two generic products

were 98–103 percent and 99–105 percent, respectively. Not only were the groups extremely close in AUC and Cmax, but there were no individual outlier patients. In addition to bioequivalence measures, there were no significant differences in seizure incidence rates or adverse effects between the two generic products. Interestingly, one patient reported increased seizures and was found to have missed medication doses. Another patient reported increased seizures but was found to actually have higher pharmacokinetic parameters at that time, arguing that the increased seizures were not caused by low serum concentration of the drug but rather other factors. Testing generics in a single-dose study A single-dose study by the EQUIGEN group assessed brand and the two most disparate generic lamotrigine products and showed similar results. This study has only been reported as an abstract as of this writing (Berg, et al., 2016). The study of 46 patients tested single-dose bioequivalence, which is thought to be more sensitive to show small pharmacokinetic differences. A single dose of 25 mg of branded lamotrigine and two disparate generics were evaluated over 96 hours and demonstrated bioequivalence in AUC and Cmax. All three products demonstrated essentially identical PK profiles. Additionally, there was no evidence of difference in within-subject variability across the three products. Adherence issues If brand and generic AEDs are bioequivalent, then why have there been so many reports of problems? Pill appearance can have an effect on adherence. A study of 11,472 patients initiated on AEDs with medication nonpersistence (failure to fill a prescription within five days of expected lapse of supply) versus 50,050 controls found that the risk of nonpersistence after pill color change was elevated with Generic antiepileptic drug substitution to page 50

BEYOND TREATING, THERE’S CARING W E L L A N D BE YO N D Fairview Health Services seeks physicians with an unwavering focus on delivering the best clinical care and a passion for providing outstanding patient experience.

We currently have opportunities in the following areas: • Dermatology

• Internal Medicine

• Pain Medicine

• Emergency Medicine

• Medical Director

• Palliative Care

• Endocrinology

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• Pediatrics

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• OB/GYN

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• Orthopedic • Geriatric Medicine Surgery • Hospitalist

• Otolaryngology

• Urology • Vascular Medicine

To learn more, visit fairview.org/physicians, call 800-842-6469 or email recruit1@ fairview.org fairview.org/physicians TTY 612- 672-7300 EEO/AA Employer

Sorry, no J1 opportunities.

Employment Opportunity

The perfect match of career and lifestyle. Affiliated Community Medical Centers is a physician owned multispecialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties: • Dermatology • ENT • Family Medicine • Gastroenterology • General Surgery • Geriatrician • Outpatient Internal Medicine

• Hospitalist • Infectious Disease • Internal Medicine • OB/GYN • Oncology • Orthopedic Surgery • Pediatrics

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

• Psychiatry • Psychology • Pulmonary/ Critical Care • Rheumatology • Sleep Medicine • Urgent Care

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Clinic Administrator Orthopaedic Associates of Duluth, P.A. is a physician-owned, highly reputable, well established clinic with ten physicians, eight physician assistants, and nine physical and occupational therapists. We are seeking an experienced Clinic Administrator to provide strategic and operational leadership for the medical practice within our three northern MN locations. The position is responsible for overall financial and operational management of the daily activities including operations, accounting, medical and business information systems, marketing/public relations, personnel administration, and planning and development. The selected candidate will have superior management, interpersonal, and analytical skills and be a strong communicator. Must have a solid financial background and be comfortable in a clinic environment. The position continually monitors operations as well as corporate compliance, HIPAA, risk management, and patient satisfaction. Represents the clinic in its relationships with other healthcare organizations, government agencies, and third party payers. The Administrator is accountable to the physicians. Bachelors degree with 7-10+ years of experience in physician practice management required. Position offers a competitive salary and excellent benefits package. Email resume to martin.francisco@slhduluth.com or fax to attn: Martin 218-625-2728.

Family Practice Physician Join a provider-driven not-for-profit organization in our Cook, MN location. Work in a well-established, modern facility. Participate in on-call schedule, share in-patient and after-hours care, (no OB). BC/BE and current or eligible for MN license required. National Health Service Corps loan repayment potential.

WORK-LIFE BALANCE: • Competitive salary • Significant starting & residency bonuses • 4-day work weeks • 51 annual paid days off Ski, hike, run, fish, canoe, kayak, camp and more in nearby state parks, Boundary Waters Canoe Area, Voyageurs National Park and Superior National Forest. Please contact: Travis Luedke, Cook Area Health Services, Inc., 20 5th St. SE, Cook, MN 55723 tluedke@scenicrivershealth.org 218-361-3190

AUGUST 2016 MINNESOTA PHYSICIAN

Generic antiepileptic drug substitution from page 48

an Odds Ratio of 1.53 (95 percent CI 1.07–2.18) (Kesselheim, JAMA Internal Medicine, 2013). Thus, changes in tablet color that are part of current regulations could have led to adherence problems when epilepsy patients were switched. Another factor is that seizures often occur with obvious causation and a recent generic switch of an AED could have been falsely blamed. Yet, another factor contributing to the past perception that brand drugs are more effective and more tolerable than their generic counterparts could even be cost. A study of 12 patients with moderate to severe Parkinson’s disease evaluated the cost of medication on patient-perceived effectiveness of therapy (Espay et al., Neurology, 2015). Patients were randomized to a “novel injectable dopamine agonist” placebo,

either “cheap” or “expensive,” then four hours later crossed over to the other placebo. More benefit in motor function (documented by blinded motor assessments) was noted when patients were randomized first to the expensive placebo. The authors

within the FDA allowable bioequivalence range of 80–125 percent. The three most rigorous studies to date, discussed here, have shown no difference in bioequivalence when interchanging between brand and generic as well as between mul-

Generics are equivalent to brand AEDs and are not of lower efficacy.

concluded that the perception of higher cost altered the placebo response in these patients. Conclusion Given the recent pharmacokinetic data assessed in both single dose and chronic dose studies, physicians and patients can be reassured that generic and brand products are not at the far end of the spectrum

tiple generics. In light of these studies, the American Epilepsy Society modified its position statement in January of 2016 on substitution of different formulations of AEDs for epilepsy. The statement acknowledges that product substitutions among FDA-approved generics reduces cost and does not compromise efficacy. The statement comments it is best to educate

patients on possible changes in color and shape when substituting a generic product to avoid confusion and increase medication persistence. Further research is needed to address other factors related to generics including extended-release products, tablet appearance, and patient adherence. However, we can be confident to reassure patients that generics are equivalent to brand AEDs and are not of lower efficacy.

Stephanie Roller, MD, received her medical degree from Ohio State University and is currently completing her neurology residency training at the University of Cincinnati where she will continue a fellowship in epilepsy. Michael Privitera, MD, is professor of neurology and director of the Epilepsy Center of the University of Cincinnati Neuroscience Institute. He is currently president of the American Epilepsy Society. His interests focus on new antiepileptic drugs, generic equivalence of AEDs, and stress as a seizure precipitant.

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

PHYSICIAN Boynton Health is seeking a full-time physician in Primary Care and Urgent Care Clinics. We have in-house mental health, pharmacy, physical therapy, lab, x-ray and other services to provide holistic care of your patients. This position offers a competitive salary, comprehensive benefits, CME opportunities and a generous retirement plan. Professional liability coverage is provided.

To learn more, contact Hosea Ojwang, Human Resources Director at 612-626-1184, hojwang@bhs.umn.edu Apply online at http://www1.umn.edu/ohr/employment and search Keyword 306981. The University of Minnesota is an Equal Opportunity, Affirmative Action Educator and Employer.

410 Church Street SE, Minneapolis, MN 55455 612-625-8400 www.bhs.umn.edu

MINNESOTA PHYSICIAN AUGUST 2016

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The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, stateGood or local laws. Some services may housing be provided a thirdtoparty. All faiths or beliefs are welcome. 2015color, The Evangelical Lutheran Goodfamilial Samaritan Society. All rights 15-G1553statuses according The Evangelical Lutheran Samaritan Society provides and by services qualified individuals without regard to©race, religion, gender, disability, status, national origin reserved. or other protected to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. © 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553

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