THE INDEPENDENT MEDICAL BUSINESS JOURNAL
Volume XXXI, No. 5
PHYSICIAN The Minnesota Adult Abuse Reporting Center Protecting the vulnerable BY COMMISSIONER EMILY PIPER, JD
n older adult woman living in northern Minnesota was at her most vulnerable— recovering from surgery after a stroke— when she became the victim of ﬁnancial exploitation by her own daughter.
Regenerative Medicine Minnesota Transforming the future of health care BY JAKUB TOLAR, MD, PHD, AND ANDRE TERZIC, MD, PHD, FAHA
e have grown accustomed to the medical miracles—antibiotics to combat infection; transplantation to replace failed organs; and biologics to control high cholesterol, rheumatoid arthritis, or psoriasis—that have transformed patient care. Despite remarkable advances, many serious health problems resist conventional medicine and surgery, causing suffering and shortening lives. To address the growing unmet needs in an aging population, regenerative medicine brings Regenerative Medicine Minnesota to page 16
While the mother was still recovering in the hospital and a nursing home, the daughter married. Using her temporary power of attorney over her mother’s affairs, the daughter and her new husband sold the older woman’s home, ran up her credit card balances, and took her possessions, including her car, furniture, jewelry, clothing, and antiques. They left her mother in a 500-square-foot room at an assisted living facility, without the resources to pay for her care. The Minnesota Adult Abuse Reporting Center to page 20
rehabilitate a body, we start T owith the mind and soul. If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.
To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota.
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TH 4 8 SESSION AUGUST 2017
Volume XXXI, Number 5
REGENERATIVE MEDICINE: Efficacy, Economics, and Evolution
COVER FEATURES 4GIGNGRCěKUG /GFKEKNG /KNNGSOěC Transforming the future of health care
6JG /KNNGSOěC #FTĚě #DTSG 4GPORěKNI %GNěGR Protecting the vulnerable
By Jakub Tolar, MD, PhD, and Andre Terzic, MD, PhD, FAHA
By Commissioner Emily Piper, JD
HEALTH CARE REFORM 32
6JG (TěTRG OH *GCĚěJ %CRG KNKěKCěKUG Creating value-based partnerships
Thursday, November 2, 2017, 1-4 pm
By Garrett Black
The Gallery, Downtown Minneapolis Hilton and Towers INTERVIEW
A world leader in cancer prevention
Zigang Dong, MD, DrPH, The Hormel Institute
/KNNGSOěC *GCĚěJ 4GEORFS #Eě Efforts to improve a challenging process
About, objectives, background and focus:
By Bob Johnson, MPP, and Diane Rydrych, MA
The Minnesota Health Care Roundtable is a semi-annual conference featuring a panel of stakeholder group experts in a moderated discussion before a live audience covering topics that affect the evolution of health care policy.
We will deﬁne regenerative medicine and trace its development. We will explore what the pharmaceutical, device, and insurance industries are doing now with regenerative medicine and how they can work together moving forward. We will discuss the challenges that face regenerative medicine and offer potential solutions. We will look ahead so that, as we enter the third decade of the 21st century, the pace of innovation can expand in a way that is accessible, affordable, and sustainable.
%JCNIG MCNCIGMGNě Technical vs. adaptive perspectives
By David A. Frenz, MD
PHYSICIAN RESEARCH RECOGNITION # PROĂĚG OH RGSGCREJ PROęGEěS ĚGF DX /KNNGSOěC PJXSKEKCNS
By Richard Ericson
PROFESSIONAL UPDATE: ONCOLOGY 30
6JG ĂNCNEKCĚ ěOĚĚ OH ECNEGR ěJGRCPX Developing ways to help the patient
Several recent studies have reached troubling conclusions. A huge percentage of prescription medications produce little to no therapeutic beneﬁt for many patients. In large part this relates to a drug development paradigm and medical care model centered more on treating symptoms than curing root causes. An emerging solution to this problem is the ﬁeld of regenerative medicine—an approach that directly repairs or replaces damaged tissues and organs. Though initial research and development costs present signiﬁcant upfront investment, the promise of better outcomes and eventual savings are impossible to ignore.
Blake Johnson, MD Center for Diagnostic Imaging
Center for Diagnostic Imaging
David R. Brown, MD Recombinetics
Minnesota Regenerative Medicine
By Pamala A. Pawloski, PharmD; Heather Kehn, BS, RN, MPH; and Daniel M. Anderson, MD
Leigh Turner, Ph.D University of Minnesota Center for Bioethics
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EDITOR _______________________________________________ Lisa McGowan, firstname.lastname@example.org ASSOCIATE EDITOR ____________________________ Richard Ericson, email@example.com ART DIRECTOR ______________________________________________Scotty Town, firstname.lastname@example.org OFFICE ADMINISTRATOR _____________ Amanda Marlow, email@example.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; email firstname.lastname@example.org; phone 612.728.8600; fax 612.728.8601. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.
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Please mail, call in, or fax your registration! • mppub.com MINNESOTA PHYSICIAN AUGUST 2017
AUGUST 2017 MINNESOTA PHYSICIAN
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*, 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 clinical trials, see the following page.
Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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.
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
MINNESOTA PHYSICIAN AUGUST 2017
Unbeaten A1C reduction* with fewer injections 1,3
*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.
Trulicity vs Victoza®
Add-on to metformin (26 weeks) 8.1
Mean Baseline A1C (%)
Trulicity vs Lantus®
Trulicity vs Byetta®
Add-on to metformin and Amaryl® (52 weeks)
Add-on to metformin and Actos® (26 weeks)
Two efﬁcacious doses available1 Mean A1C change from baseline (%)
The recommended starting dosage of Trulicity is 0.75 mg once a week
-1.6 For patients requiring additional glycemic control, the dosage may be increased to 1.5 mg once a week
Trulicity (1.5 mg)
Trulicity (0.75 mg)
Trulicity (0.75 mg)
Victoza (1.8 mg)
Trulicity (1.5 mg)
Trulicity (1.5 mg)
Byetta (10 mcg BID) Placebo
Data represent least-squares mean.
APPROXIMATE TOTAL INJECTIONS
APPROXIMATE TOTAL INJECTIONS
APPROXIMATE TOTAL INJECTIONS
Study Descriptions Compared to Victoza3
Compared to Lantus1,5
Victoza 1.8 mg QD, SC (n=300); Trulicity 1.5 mg QW, SC (n=299)
Lantus QD, SC (n=262); Trulicity 0.75 mg QW, SC (n=272); Trulicity 1.5 mg QW, SC (n=273)
26-week, randomized, open-label comparator phase 3b study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day
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)
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 with 0.4% margin; mixed-model repeated measures analysis) Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met
Starting dose of Lantus was 10 units daily. 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 Lantus was 29 units at the primary endpoint Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus 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 last observation carried forward); primary objective met
Compared to Byetta1,6 •
Placebo (n=141); Byetta 10 mcg BID, SC (n=276); Trulicity 0.75 mg QW, SC (n=280); Trulicity 1.5 mg QW, SC (n=279)
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 last observation carried forward); primary objective met
Key secondary objectives of superiority of both Trulicity doses on A1C change from baseline vs Byetta were met
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.
AUGUST 2017 MINNESOTA PHYSICIAN
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.
The most common adverse reactions (excluding hypoglycemia) reported in ≥5% of Trulicity-treated patients in placebo-controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%), 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: Limited data with Trulicity in pregnant women are not sufﬁcient to determine a drug-associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide. Use only if potential beneﬁt justiﬁes the potential risk to the fetus. Lactation: There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health beneﬁts of breastfeeding should be considered along with the mother’s clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition.
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.
Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.
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.
DG HCP ISI 06FEB2017
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: There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions and angioedema) in patients treated with Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist as it is unknown whether they will be predisposed to anaphylaxis with Trulicity. 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.
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.
Trulicity® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Trulicity is available by prescription only. 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. 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. 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. 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). Diabetes Care. 2015;38(12):2241-2249. 6. 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.
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.
©Lilly USA, LLC 2017. All rights reserved.
MINNESOTA PHYSICIAN AUGUST 2017
Trulicity® (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 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.
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. 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 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: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Trulicity. If a hypersensitivity reaction occurs, the patient should discontinue
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. Add-on to Glimepiride at 24 weeks, Placebo (N=60), Trulicity 1.5 mg (N=239), Documented symptomatic: Placebo: 1.7%, 1.5 mg: 11.3%; Severe: all 0. Add-on to Insulin Glargine with or without Metformin at 28 weeks, Placebo (N=150), Trulicity 1.5 mg (N=150), Documented symptomatic: Placebo: 30.0% 1.5 mg: 35.3%; Severe: Placebo: 0% 1.5 mg: 0.7%. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. In a 78-week clinical trial 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
INDICATIONS AND USAGE Trulicity® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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. 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 and other suspected medications and promptly seek medical advice. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with Trulicity. 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.
AUGUST 2017 MINNESOTA PHYSICIAN
DG HCP BS 10FEB2017 7 x 9.5
DG HCP BS 10FEB2017 7 x 9.5
symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg 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%. Postmarketing Experience: Anaphylactic reactions have been reported during post-approval use of Trulicity. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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: Risk Summary Limited data with Trulicity in pregnant women are not sufficient to determine a drug associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 14-times human exposure at the maximum recommended human dose (MRHD) of 1.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 13-times human exposure at the MRHD. Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. Lactation: Risk Summary There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition. 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 Trulicity® (dulaglutide)
DG HCP BS 10FEB2017 7 x 9.5
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%) Trulicity-treated 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). 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 non-severe 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 Trulicity and other 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 10FEB2017 Trulicity® (dulaglutide)
DG HCP BS 10FEB2017 7 x 9.5 MINNESOTA PHYSICIAN AUGUST 2017
Essentia Health Expanding Essentia Health is investing $14 million to expand its Grand Rapids Clinic and becoming a minority owner of Lakewood Surgery Center. The project will allow patients in Itasca County and the surrounding area increased access to services. The project and association will bring increased access to cardiology, podiatry, and other orthopedic services, as well as future access to urology, and ear, nose and throat (ENT) care. In addition, oral surgery care will be provided through further partnership with a local dental group in Grand Rapids. “Our patients will receive the appropriate care right here in Grand Rapids, with the same physicians they’re used to seeing, but now have access to Essentia specialists if they need that level of care,” said Daniel Margo, MD, general surgeon and chair of Lakewood Surgery Center’s board of directors.
Construction is set to begin in July with a planned completion date of late spring 2018.
Mayo Clinic Forms New Research Agreement Mayo Clinic Health System and the University of Wisconsin-Eau Claire have agreed to a master collaboration research agreement that will allow researchers at the institutes to partner on projects. While they have worked together on individual projects in the past, the agreement will expand opportunities for collaboration. It is the ﬁrst of its kind between the institutions. “Given our shared commitment to advancing research, it makes great sense that UW-Eau Claire and Mayo Clinic would look for new, strategic and intentional ways we can work together to accomplish our goals,” said UW-Eau Claire chancellor James Schmidt, EdD, MBA. “By creating a master collaborative research
agreement, we can simplify the steps to working together. This will make it possible for even more of our faculty, staff, and students to work alongside esteemed Mayo Clinic physicians and scientists.” According to UW-Eau Claire, on average over the last three years, 45 percent of its students participate in undergraduate research projects. They hope that number will rise with the partnership. “This is an exciting opportunity for us to work together to help to improve the health and wellness of the residents of the Chippewa Valley,” said Donn Dexter, MD, chair of education for Mayo Clinic Health System, northwest Wisconsin. “It will also enhance the educational experience of the health care providers of the future—a vital part of our workforce.” The ﬁve-year agreement will automatically renew for one-year periods. Both organizations will continue to nurture existing partnerships
and seek additional opportunities to work with external research partners in Chippewa Valley and other areas.
Geriatric Behavioral Health Unit Opens CentraCare Health–Monticello has opened a geriatric behavioral unit to provide 24/7 inpatient psychological and behavioral care to patients ages 55 and older who require treatment and management of mental health conditions including depression, bipolar disorder, schizophrenia, and dementia. The unit is the ﬁrst of its kind to use an innovative model of care led by geriatricians partnering with psychiatrists, nurses, and families to care for the whole person. “Older patients rarely have one medical problem but rather present with multimorbidity and geriatric syndromes. This is very true of those seniors suffering from psychiatric distress. Diabetes, hypertension, and polypharmacy are all examples of
Gregory L. Barth, M.D. Micah A. Berman, M. D. Merrill A. Biel, M.D., Ph.D. Thomas E. Christenson, M.D.
Ear, Nose & Throat SpecialtyCare
Karin E. Evan, M.D.
takes pleasure in announcing
William J. Garvis, M.D. Matthew S. Griebie, M.D. Michael B. Johnson, M.D. Nissim Khabie, M.D. Jeffrey C. Manlove, M.D.
Nathan D. Johnson, M.D. In the practice of: Otolaryngology — Facial Plastic Surgery AND
Darren R. McDonald, M.D.
Nathan M. Schularick, M.D.
Michael P. Murphy, M.D.
In the practice of: Otolaryngology — Head and Neck Surgery
Michelle C. Naylor, M.D. llya Perepelitsyn, M.D.
Minneapolis • St. Paul • Burnsville • Coon Rapids Edina • Fridley • Maple Grove • Plymouth
Julie C. Reddan, M.D. Benhoor Soumekh, M.D. Jon V. Thomas, M.D. Larry A. Zieske, M.D. 10
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problems that should be managed differently in frail elders. This new unit offers team-based care led by a Genevive geriatrician. So, in addition to accessing the top rate care offered by CentraCare Health psychiatrists, our patients will have exposure to expert holistic geriatric care that will follow the patient back into the community. We will understand the medical, cognitive, functional, and psychosocial factors that make up the whole and deliver a plan that is tailored and truthful.” The unit offers psychiatric care, goal development, medication management, and family education, as well as support services including pet therapy, baking and cooking, yoga, music therapy, aromatherapy, and art therapy.
clinical care of our sickest patients in our neonatal intensive care units,” said Nancy Mendelsohn, MD, chief of specialty pediatrics at Children’s Minnesota. “This enables us to quickly customize treatment for these fragile patients and improve or save their lives.” Rady Children’s Institute for Genomic Medicine has performed rWGS for 100 families with acutely ill children enrolled in its research studies since July 2016. Among those patients, 40 percent received a genomic diagnosis with 80 percent beneﬁtting from an immediate change in clinical care.
Children’s Partners to Treat Acutely Ill Infants
Surgery does not signiﬁcantly reduce prostate cancer deaths for men who are diagnosed in early stages of the disease, according to a Department of Veterans Affairs clinical trial that spanned nearly 20 years. The study, called the Prostate Cancer Intervention Versus Observation Trial (PIVOT), concluded that there was no “statistically signiﬁcant difference” in deaths from any cause or speciﬁcally prostate cancer, when comparing early surgery and observation (which included regular monitoring using the PSA blood test and delayed treatments to reduce symptoms if they develop). Researchers found that death from prostate cancer in men treated with observation was uncommon (11 percent) and rare (5 percent) in men with low-risk disease. In addition, while most men with localized prostate cancer have an excellent prognosis without early treatment, men with more aggressive tumors have a poorer prognosis. According to the researchers, some of the ﬁndings seem to suggest that some mortality results leaned more favorably toward surgery than observation, however they caution that those ﬁndings were small in absolute terms (6 percent or less), not “statistically signiﬁcant,” and should
A new agreement will allow Children’s Minnesota to improve care for critically ill infants in its neonatal intensive care unit (NICU). The health care system has partnered with San Diego-based Rady Children’s Institute for Genomic Medicine, which will now provide Rapid Whole Genome Sequencing (rWGS) services to offer earlier, more targeted medical intervention for children with conditions that are not otherwise readily identiﬁable. “The future of pediatric medicine is being transformed by the ability to rapidly decode the genomes of the most fragile newborns to deliver exact diagnoses and targeted treatment,” said Stephen Kingsmore, MD, DSc, president and CEO of Rady Children’s Institute for Genomic Medicine. Through the collaboration, Children’s will send blood samples to the Institute’s clinical genome center where rWGS, bioinformatics analysis, and clinical interpretation will be conducted with a goal of delivering an exact diagnosis in as little as two days. “We are excited to incorporate these genomic ﬁndings into the
Surgery Not Always Best for Prostate Cancer
Creating Healing Environments for 38 Years
“We wouldn’t hesitate to work with Engan Associates again.” (Matt Reinertson, Heartland Orthopedic Specialists)
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be weighed against large increases in treatment harms. For example, surgery caused complications within 30 days in about 20 percent of men and resulted in long-term increases of 30 percent or more in urinary incontinence, erectile dysfunction, and dissatisfaction with sexual performance as well as treatment-related bother and reductions in daily functioning. In addition, surgery decreased disease progression treatment by about 25 percent, though most treatment was for asymptomatic or PSA reasons where treatment beneﬁts are not clear. “These results suggest that for most men, observation or PSA-based active monitoring can result in similar very long-term all-cause and prostate cancer-speciﬁc mortality, while avoiding harms of radical intervention,” said Timothy Wilt, MD, a physician-researcher with the Center for Chronic Disease Outcomes Research at the Minneapolis VA Health Care System and professor of medicine at the University of Minnesota,
who led the trial. “Findings from PIVOT and similar studies will improve prostate cancer care, in part, by reducing over-diagnosis and overtreatment harms, as well as by stimulating new research to identify safe and effective therapies in men with higher-risk disease.”
North Memorial Acquires Multicare Multicare Associates, Inc., a provider-owned and operated primary care provider, has merged with North Memorial Health. Through the new agreement, North Memorial Health will assume responsibility for all operations at the Multicare Associates clinics in Blaine, Fridley, and Roseville, and Multicare’s physicians and staff will become employees of North Memorial Health. There will not be a disruption in care services for patients. The organizations have worked together in the past and partnered
in opening an Urgency Center in Blaine in 2013.
St. Joseph’s Hospital Ends Maternity Care HealthEast has discontinued maternity care services at St. Joseph’s Hospital in downtown St. Paul, effective Sept. 10. The health care system attributes the change to the fact that more patients are choosing to give birth at its other facilities, including HealthEast St. John’s and Woodwinds hospitals. “We routinely evaluate volumes and market projections to ensure our services are aligned with the needs of our communities,” said John Kvasnicka, MD, vice president of medical affairs at HealthEast. “These projections show that more moms-to-be will be delivering their babies at our St. John’s Hospital in Maplewood and Woodwinds Health Campus in Woodbury while we see a steady decline of maternity patients at St.
Joseph’s with no projected improvement in the future. While this was not an easy decision, this change will ensure that we can provide the right care environment to deliver the best patient experience, invest in the facilities where we see increased growth, and continue to provide safe and high-quality destinations for care.” A cross-functional team is working to transition maternity care and residency programs from St. Joseph’s to other HealthEast hospitals so patients will have a seamless care experience. Maternity patients will continue to be admitted to St. Joseph’s through Sept. 7. St. Joseph’s providers who have patients planning to deliver at the hospital after that date will be asked to create a plan to deliver their patients at another hospital. Patients will receive letters notifying them of the change. HealthEast plans on no job losses with the transition, and will work with members of the St Joseph’s maternity care team to ﬁnd them other opportunities.
University of Minnesota - Continuing Professional Development "The University of Minnesota, Interprofessional Continuing Education organization is a Jointly Accredited Provider of quality continuing education in medicine, nursing, and pharmacy. As a joint provider, we design, develop, implement, assess, evaluate, and accredit activities for individual or multiple health professions. Through our activities and services, we aim to support the continuing professional development of health care providers so they can learn from, with, and about each other to improve patient outcomes."
Upcoming CPD Activities (All activities in the Twin Cities unless noted)
LIVE ACTIVITIES Twin Cities Sports Medicine Conference: Marathon Weekend ECMO Symposium: Advanced Management of the Failing Lung or Heart
Donald Gleason Conference on Prostate and Urologic Cancers
Interested in planning a CME activity? Learn more: z.umn.edu/activity-planning
Emerging Infections in Clinical Practice and Public Health
For a full listing of activities, visit: cme.umn.edu
Annual Updates in Neurology for Primary Care Practical Dermatology Child Abuse Summit: Tips from the Team Psychiatry Review: The Complex Puzzle of Addiction, Neuroscience Frontiers Children's Orthopaedic Trauma Summit
AUGUST 2017 MINNESOTA PHYSICIAN
OME Best Practices Day: The Science of Learning Bariatric Education Days: Managing Obesity Through the Lifespan
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Emily Chapman, MD, has been named the new chief medical ofﬁcer and vice president of medical affairs at Children’s Minnesota, moving from her most recent role as vice chief medical ofﬁcer. She has been with the system for more than a decade, previously serving in the role of director of the hospitalist program and of graduate medical education. Chapman earned her MD at the University of Minnesota Medical School where she also completed her pediatric residency. Clark Chen, MD, PhD, a nationally recognized brain tumor researcher and surgeon, has been named the Lyle French Chair in Neurosurgery and the head of the University of Minnesota Medical School Department of Neurosurgery. Chen comes from the University of California San Diego where he served as chief of stereotactic and radiosurgery, vice-chairman of neurology, and professor of neurosurgery. He has authored more than 200 peer-reviewed papers in the ﬁeld of neurooncology and is the recipient of several highly competitive research awards. He is also a leader in the study of DNA repair and gene therapy in brain tumors. Chen earned a master’s degree in epidemiology from Columbia University, a medical degree and PhD from Harvard Medical School, and completed his neurosurgery training at Massachusetts General Hospital, which included a clinical fellowship on radiosurgery and a second fellowship on stereotactic neurosurgery. Michael Silber, MB, ChB, dean of Mayo Clinic School of Health Sciences and professor of neurology at Mayo Clinic, has received the Excellence in Education Award from the American Academy of Sleep Medicine (AASM) for outstanding contributions in the teaching of sleep medicine. His previous roles include president of the AASM, president of the American Board of Sleep Medicine, chair of the Sleep Medicine Fellowship Directors Council, and co-director of the Mayo Clinic Center for Sleep Medicine. He also served as program director of the Mayo Clinic Fellowship in Sleep Medicine for 14 years, through which he educated 60 fellows. Silber earned a medical degree from the University of Cape Town, South Africa, trained in internal medicine and neurology at Groote Schuur Hospital in Cape Town, and completed a fellowship in neurology at the Mayo Clinic. Jay Collins, MD, director of surgical and specialty care at the St. Cloud VA Health Care System, was recognized with the Physician’s Award for Clinical Excellence as part of the health care system’s Distinguished Civil Servants awards. The awards honor employees who provide the best in care and compassion for veterans. He earned his medical degree at Wayne State University School of Medicine.
MINNESOTA PHYSICIAN AUGUST 2017
A world leader in cancer prevention Zigang Dong, MD, DrPH, The Hormel Institute
Tell us about the history of The Hormel Institute.
The Hormel Institute (HI) was founded in 1942 by Jay C. Hormel and started out by providing early research through the University of Minnesota for Hormel Foods—e.g., food preservation and food safety studies. The Hormel Institute became a world leader in lipid research in the 1950s and 60s, including Dr. Ralph Holman’s naming and research of omega-3 and omega-6 essential fatty acids. The Institute moved to a focus on cancer research in the 1990s and has achieved transformational accomplishments. We tripled in size in 2008, doubled the number of faculty research positions, tripled the number of research sections, and added the International Center of Research Technology, which provides cutting edge technologies to advance our science. Just eight years later we again doubled in size with another expansion in 2016 including 42 state-of-the-art research labs and a cryo-EM (cryoelectron microscope) suite. All of this is designed to accelerate ﬁnding answers to cancer. What does your work as the executive director entail?
My responsibility is to ensure that our resources are used efﬁciently and expansively to further discoveries in cancer research. Our vision for the future is to hire top faculty from around the world, as well as top management staff to conduct and win support for our research. I also have to help win the support of collaborative partners to ensure that our goals are reached. By working closely with important co-leaders such as our associate director Dr. Ann Bode, we ensure that all departments/ research sections work together to carry out the mission of accelerating answers to cancer. I also work with professors on cancer research grant applications and ensure they receive support to help them publish in high-impact journals. Finally, I must help win the support of our leadership, the community, the region, the nation, and international community for our work. Please tell us about a few of The Hormel Institute’s research projects.
Every major cancer—skin, breast, prostate, lung, colon, leukemia, and others—is studied along with lesser-known cancers such as Wilms Tumor.
AUGUST 2017 MINNESOTA PHYSICIAN
HI is a world leader in cancer prevention research and the study of molecular mechanisms of tumor development, the research of tumor stem cells, and tumor therapeutic and preventive mechanisms.
The advancement of science and technology has always walked arm in arm.
Innovative research is also conducted thanks to a regional community initiative called “Paint the Town Pink.” The all Pink campaign is ofﬁcially held for two weeks in February, with supporting events held year round. The initiative began in 2011 and raised $23,000 and this year raised $302,000 from events that ranged from the signature Austin Bruins’ “Paint the Rink Pink” hockey game, to a Plunging For Pink polar plunge, to event after event in Austin and small nearby towns. It is a great “coming together” for the cause of raising funds for cancer research as well as cancer prevention education. Donations allow us to offer starter “seed” grants to HI scientists with novel ideas for breast or general cancer research. You recently expanded the Institute nearly doubling its size. What does this mean for you?
The addition of another research building allows us to continue to expand our research and
hire more world-class scientists. The new building houses the cryo-EM lab with professor Dr. Anna Sundborger, an expert structural biologist. Cryo-Em is the world’s most powerful microscope and is one of only a few in the U.S. It will be key in helping us understand cancer development and developing drug therapies. In addition, the expansion added a global communications center named the Ray Live Learning Center, which includes an event room and a 250-person auditorium where we have hosted four international cancer conferences since the Center opened. These conferences allow us to bring high-caliber researchers from across the globe to our facility, which has been invaluable. The expansion also allows us to bring in additional principal investigators (PIs)—we are currently in the process of hiring about 130 more faculty and staff—which means more collaborators, more discoveries, and greater momentum toward ﬁnding new ways to treat and prevent cancer. Talk about some of your research partners and how you collaborate with them.
We partner with cancer research institutes across the world. We have established a “Hormel Institute” within Zhengzhou University in China as well as labs in South Korea. We have research partnerships with Mayo Clinic, MD Anderson Cancer Center, Columbia University, and many more. We also collaborate with institutes worldwide on conducting clinical trials. Each of our PIs has a multitude of research partnerships and collaborations. Our view is that the more knowledge and information we share, the faster we can all ﬁnd answers. We are also part of the Minnesota Chemoprevention Consortium, a group of institutions who work to ﬁnd alternatives to chemotherapy and radiation, or ways to mitigate the effects of those treatments on patients’ lives. What innovations have been important to ěJG +NSěKěTěG¥S RGSGCREJ GėORěS!
The advancement of science and technology has always walked arm in arm. As one industry advances, it affects others. Technology of all kinds is a major investment and resource at HI and it accelerates our understanding of cancer development and provides the latest information faster and better. The Hormel Institute has two
supercomputers, a computational biology and biomedical information computer lab, confocal microscopes, 3D technology, mass spectrometry and cell sorters, a protein crystallography lab, and the latest acquisition, a cryo-electron microscope. In line with the scientiďŹ c objectives and goals for The Hormel Institute, it was apparent a powerful transmission electron microscope (TEM) to deliver 3D characterizations of biological and biomaterials samples in cell biology, structural biology, and nanotechnology research would be an extremely important asset. The cryo-EM technology enables our researchers to quickly obtain better insight and understanding of macromolecular structures, cellular components, cells and tissues in three dimensions in the quest to accelerate cancer research discoveries to improve human health. Cryo-EM is increasingly becoming a mainstream technology for studying the architecture of cells, viruses, and protein assemblies at molecular resolution and was not anticipated in the original building design. Our donors, including The Hormel Foundation and Hormel Foods, have advanced global communications technology to accelerate collaborations with scientists/partners worldwide. We are always advancing technology at The Hormel Instituteâ&#x20AC;&#x201D;indeed these are â&#x20AC;&#x153;cancer ďŹ ghting tools.â&#x20AC;?
Tell us about your recent launch of Nature Partner Journal Precision Oncology.
In March, The Hormel Institute announced its inaugural launch of Nature Partner Journal (npj) Precision Oncology. The milestone publication links The Hormel Instituteâ&#x20AC;&#x2122;s cancer research with Nature (Oxford, England) the top scientiďŹ c research journal in the world. Nature Partner Journals are an online-only, open access series of Nature Research journals, published by Springer Nature in partnership with global academic institutions, centers of excellence, philanthropic funders, and membership associations. What are some of the biggest challenges HCEKNI XOTR RGSGCREJ GÄ&#x2014;ORÄ&#x203A;S!
Ensuring that federal research grants are funded. With a growing threat to the national budgets of NIH (National Institutes of Health) and Department of Defense and others, it makes it increasingly burdensome for our outstanding researchers to be assured of securing grantsâ&#x20AC;&#x201D;the very substance of their livelihood. While we can provide a beautiful state-of-the-art facility, it is a PIâ&#x20AC;&#x2122;s responsibility to write and win major grants to fund their research. We offer more than most research centers, with very generous support, but a PI in essence must fund his or her own research.
The Hormel Foundation covers 75 percent of a PIâ&#x20AC;&#x2122;s salary and administrative costs allowing generous support of research (e.g., purchase of the cryo-EM microscope) and allowing more funding to ďŹ&#x201A;ow directly to our research efforts. What does the future hold for The Hormel Institute?
The Hormel Institute, University of Minnesota will continue to progress and grow in distinction and recognition as a world leader in cancer prevention research. Our discoveries are aimed to improve the health of the world and so that is the vision of our futureâ&#x20AC;&#x201D;we will apply our science, our resources, and our decisions to ensuring that impact is made. Zigang Dong, MD, DrPH, is the executive director, Hormel/Knowlton Professor, and I. J. Holton Professor of The Hormel Institute, University of Minnesota. In 2006, he received the University of Minnesota McKnight Presidential Professorship in Cancer Prevention, one of the highest honors bestowed by the university. He is one of very few professors holding three endowed professorships at the same time at the University of Minnesota. Dr. Dong is a world leader in the ďŹ eld of cancer prevention and molecular carcinogenesis.
9 PTSD is now an approved condition 9
HAVE YOU REGISTERED WITH THE MINNESOTA MEDICAL CANNABIS PROGRAM? Registration can be done online; there is no fee and it takes only a few minutes. Visit the registry website: mn.gov/medicalcannabis Your account will provide access to medical cannabis purchasing information from patients you certify. Once you are registered, you will be able to certify patients with a variety of conditions, including: â&#x20AC;˘ Cancer, Glaucoma, Tourette Syndrome, HIV/AIDS, and ALS
â&#x20AC;˘ Â&#x2DC;y>Â&#x201C;Â&#x201C;>Ă&#x152;Â&#x153;Ă&#x20AC;Ă&#x17E; LÂ&#x153;Ă&#x153;iÂ? `Â&#x2C6;Ă&#x192;i>Ă&#x192;i] Â&#x2C6;Â&#x2DC;VÂ?Ă&#x2022;`Â&#x2C6;Â&#x2DC;} Crohnâ&#x20AC;&#x2122;s disease
â&#x20AC;˘ Seizures, including those characteristic of Epilepsy
â&#x20AC;˘ Terminal illness, with a probable life expectancy of less than one year â&#x20AC;˘ Intractable Pain â&#x20AC;˘ Post-Traumatic Stress Disorder
â&#x20AC;˘ Severe and persistent muscle spasms, including those characteristic of MS
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OFFICE OF MEDICAL CANNABIS
(651) 201-5598: Metro (844) 879-3381: Non-metro P.O. Box 64882, St. Paul, MN 55164-0882 firstname.lastname@example.org
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MINNESOTA PHYSICIAN AUGUST 2017
Regenerative Medicine Minnesota from cover together the next generation of technologies to provide hope for patients suffering from chronic lifelong diseases such as heart failure, cancer, or diabetes. Biomedical engineering, stem cell science, genome editing, and acellular repair have all contributed to achieving regenerative outcomes across degenerative disorders (e.g., multiple sclerosis, amyotrophic lateral sclerosis [ALS], Alzheimer’s disease), offered alternative solutions to address the lack of organ donors (affecting more than 100,000 Americans each year), or ameliorated prognosis in debilitating conditions aggravated by malfunctioning tissues (e.g., joint deterioration). In short, regenerative medicine offers a healthier, more functional future for millions of people who currently have no treatment options.
Operating rhythm On May 16, 2014, the Minnesota State Legislature took a leap of faith into the future and funded a 10-year Minnesota Regenerative Medicine Act to promote “regenerative medicine research, clinical translation, and commercialization” across the state. The Legislature allotted $4.5 million to be awarded in the ﬁrst year and $4.35 million each year thereafter. To fulﬁll the requirements of the bill, a Board was formed of ﬁve representatives who brought experience from private industry, regenerative medicine research, clinical translation, commercialization, and medical venture ﬁnancing. As steward of this initiative, the Regenerative Medicine Minnesota (RMM) Board reviewed ongoing state initiatives—for example, the California Institute of Regenerative Medicine (CIRM), the largest regenerative
medicine program in the U.S. The RMM Board also considered the State of Minnesota as a unique home for this endeavor. Minnesota has a remarkable history of medical innovation, biotechnology invention, and a population encompassing those who have access to the most advanced health care and those who are frequently underserved. Accordingly, RMM strives to improve the health of Minnesotans by promoting and advancing regenerative medicine research, education, industry, and delivery to patients. RMM proposed to fund the cutting-edge discoveries that underpin the development and dissemination of potentially life-saving products, while cultivating the build-out of the production pipeline and the education of patients and caregivers, so that once ready, regenerative medicine therapies can be distributed throughout the state. On Nov. 6, 2014, RMM (originally known as Minnesota Regenerative Medicine), released a business plan. Shortly thereafter (on Nov. 14, 2014), requests for proposals for research grants; education grants; scholarships; patient care grants; biotechnology/biobusiness development grants; and a website development and maintenance contract were distributed statewide.
Science Research is the largest part of the program, and 25 projects have been funded over the initial three years for a total investment of just under $9 million. Grants were awarded based on independent scores from experts in regenerative science from outside the state of Minnesota. In the ﬁrst year, grants were divided by organ system. Thereafter, they were classiﬁed into research types: 1) discovery science, 2) translational research, and 3) clinical trials. Given that research projects require considerable infrastructure and multidisciplinary teams, it was not unexpected that the majority of proposals came from and were awarded to investigators at the University of Minnesota and Mayo Clinic. In an effort to balance the research portfolio with investigators from all stages of professional development, recent emphasis has been on early-career investigators. Of note, out-of-state reviewers have been consistently impressed both by the high quality of the proposals and the forethought of the Minnesota Legislature.
Business The second largest part of the program centers on manufacturing and development and funds 22 projects with about $2.6 million. It supports development in Minnesota of the capacity to produce scalable and standardized regenerative therapies in accordance with Current Good Manufacturing Practices, so that qualiﬁed facilities exist to produce both cellular and non-cellular therapies for clinical use. Ensuring advanced manufacturing capabilities positions Minnesota at the forefront of the regenerative industry. This piece is critical to attracting new business to the state and creating new jobs, while expediting the production at scale of cost-effective, ready-to-use regenerative products. Enhancing the readiness of the state to serve as a hub for advancing regenerative enterprise is a stated priority in the years to come.
Education The third largest focus of the program is education and outreach, funding 44 initiatives at just over $2 million. Initially, plans used funds to train and retain university students in regenerative medicine projects in Minnesota through a scholarship program and to fund education programs for students in grades 3 through 12. Once the request for proposals was released, it quickly became apparent that there was enormous interest and potential for education programs at all levels, so the competition was widened to expand the learner base.
AUGUST 2017 MINNESOTA PHYSICIAN
paramedical staff, scholars, industry, government, and the community The education programs have been a major success for RMM for several around the state to help identify them. Future directions include activating reasons. Teaching students about regenerative medicine and health care and expanding science-driven patient care delivery statewide; continuing careers educates families, not just participants. Education programs have to redesign and improve the website (www.regenmedmn.org), which is our been the best vehicle to expand the reach of RMM throughout the state. primary communication and outreach tool; and reworking the biobusiness/ Many teachers are used to working collaboratively, so they spontaneously biotechnology grant application and review process to amplify impact on began creating networks, pooling curricula, and sharing resources. After the state bioindustry. RMM will continue to champion this exciting future and ďŹ rst year, the programs were so successful that the Board felt that the most develop its programs to match the interest in health effective use of funds was to discontinue supporting care empowered by advances in medical science. individual students and to instead help develop programs that supported groups of students. We have had programs that train veterans for laboratory careers Jakub Tolar, MD, PhD, is the executive vice dean of using an accelerated â&#x20AC;&#x153;bootcampâ&#x20AC;? approach. We helped the Medical School, director of the Stem Cell Institute, to expand the successful Scrubs Camp program that Minnesota has a remarkable and a distinguished McKnight Professor of Pediatrics prepares middle and high school students for careers history of medical innovation. at the University of Minnesota. He is co-chair of the in science and medicine. Several programs work with Regenerative Medicine Minnesota Board. communities to build an interest in regenerative medicine through activities based in Native American culture. A number of additional programs work with Andre Terzic, MD, PhD, FAHA, is the Michael S. and medical students to speciďŹ cally interest them in Mary Sue Shannon Director at the Mayo Clinic Center regenerative medicine research and/or practice. In the for Regenerative Medicine; the Marriott Family Professor past year, the grade levels were changed to kindergarten in Cardiovascular Medicine; and the Marriott Family Director of Comprehensive and above, thereby including students at every level of education in the state. Cardiac Regenerative Medicine at Mayo Clinic. He is professor of medicine and RMM also attended the annual Minnesota Education Association meeting pharmacology; chair of the Discovery-Translation Advisory Board; and director and had an article in the Minnesota Science Teachers Association Newsletter to help spread the word about the availability of funds and support. of the National Institutes of Health â&#x20AC;&#x153;Cardiovasologyâ&#x20AC;? Program. He serves as
co-chair of the Regenerative Medicine Minnesota Board.
One of the key guiding principles behind the program has been to evolve in an iterative manner, learning from growing experience in the ďŹ eld and responding to state needs. The initial steps of RMM, along with experiences from others, have informed how best to adapt and enrich the program each year to maximize the impact on stakeholders. In this context, the Boardâ&#x20AC;&#x2122;s vision has remained steadfast, yet the process and programs are nimble and under constant review to ďŹ nd ways to improve them and ensure early adoption of regenerative solutions that address patient needs.
Patients For RMM, success of the program is measured in lives improved, so patient care delivery is key to overall success. Other markers of successâ&#x20AC;&#x201D; job creation, student engagement, and clinical trialsâ&#x20AC;&#x201D;have touched lives, thereby further supporting the ultimate goal of the program of improving the health of all Minnesotans. As other subprograms gain momentum, RMM will increasingly focus on care delivery. To foster this growth, it will be critical to partner with health care providers across the state who can identify and recruit patient populations that would beneďŹ t from clinically proven safe and effective regenerative therapies. Some examples of how patient care delivery funds could be used include: 1) developing the capacity of smaller clinics to participate in clinical trials (building out trial management, creating dedicated registries, and supporting multi-site analytics to ensure state-wide competitiveness); 2) providing equipment and infrastructure to increase access to inpatient and outpatient regenerative therapies; and 3) enhancing affordability of regenerative treatments through coordinated and sponsored patient-centric programs.
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The future There are undoubtedly many other ways to extend the reach of RMM. The program depends on input from medical professionals, scientists,
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MINNESOTA PHYSICIAN AUGUST 2017
Change management Technical vs. adaptive perspectives BY DAVID A. FRENZ, MD
any health care organizations are faced with a growing number of business challenges. As these challenges become more complex, so, too, the thinking required for potential solutions. Let’s look at a ﬁctional case study.
Brian’s clinic was imploding. Sagging ﬁnancials prompted him to increase patient encounters to address the revenue side of the equation. He also trimmed expenses by eliminating some support staff. His providers, who were initially skeptical of the plan, eventually revolted. One of his physicians resigned and others were openly talking about bailing. Brian worried that losing more providers could trigger a death spiral. Lately, he’s been asking himself, “Where did I go wrong? How can I undo this mess?” What do you think? What was Brian’s mistake? The answers may surprise and possibly unsettle you.
Diagnosis before treatment I’ve been teaching evidence-based medicine at the University of Minnesota since 2004. I like to remind my students that therapeutic failures are often diagnostic screw-ups: wrong diagnosis = wrong therapy. The same is true
in health care administration. Most leaders, especially in health care, take a primarily technical approach to management. In Brian’s case, he sized up his clinic’s balance sheet and correctly determined that revenue and expenses were out of whack. He then instituted countermeasures—juicing revenue, trimming expenses—to achieve a target margin. His math was right but the diagnosis was wrong. How could that be? Ronald Heifetz, MD, the Harvard leadership professor, has long argued that diagnosis is more fundamental and abstract than we assume. The ﬁrst question leaders should ask themselves is whether a problem is primarily technical or adaptive. Landing in the right category drives all of the strategies and tactics that follow. (Throughout this article I use the qualiﬁer primarily to admit the inevitable shades of grey. In reality, problems generally contain both technical and adaptive elements. The key is parsing them and not confusing one for the other.) So what’s the difference? Technical problems are relatively easy to size up and have known solutions. Heifetz uses infections (antibiotics) and valvular heart disease (cardiac surgery) as examples. The solutions aren’t necessarily painless, easy, or risk-free—think aortic valve replacement—but the course of action is generally clear, at least to experts. Adaptive challenges, on the other hand, involve ambiguous circumstances, lack of obvious solutions, or both. Moreover, as Heifetz notes, “They are not amenable to authoritative expertise, although people might hope that if the right subject matter expert could only be found, these problems would be solved.” In brief, they involve “leadership without easy answers.”
Management misdiagnoses This all looks pretty straightforward, however, recognizing adaptive challenges is much harder than it seems. Let’s return to our opening case study to see why. Brian felt that he was dealing with a straightforward problem: a mismatch between revenue and expenses. In his mind, the solution was also clear: improving revenue through more patient encounters and decreasing expenses by reducing staff. What he missed, however, was the type of direction that his clinic needed and an adaptive approach to protection and orientation (see Table 1). Take, for instance, the larger external context. Why, exactly, was revenue down? Had third-party payers decreased their reimbursement rates? Did the payer mix shift to more government insurance? Was revenue now contingent on achieving clinical and ﬁnancial outcomes? Where did Brian’s clinic stand vis-à-vis these risk/gain-sharing goals? Was there a revenue cycle problem due to bad debt or payment lags from insurance companies? The problem deﬁnition suddenly isn’t so clear. Brian’s desire to restore order by implementing solutions led him to ignore external pressures that could ultimately cause his clinic to fail. And he didn’t help himself by choosing a narrow technical ﬁx that only compounded his problems.
Cognitive errors I’m intensely interested in how doctors—and, more generally, humans— make mistakes. Understanding how errors happen suggests possible strategies for avoiding catastrophes in the ﬁrst place, or at least minimizing
AUGUST 2017 MINNESOTA PHYSICIAN
their damage. Psychologists have discovered an astonishing number of cognitive biases and traps that we all fall into. Rolf Dobelli provides an accessible introduction to 99 of them in his bestseller, The Art of Thinking Clearly. More ambitious readers may want to tackle Nobel laureate Daniel Kahneman’s Thinking, Fast and Slow, or James Reason’s Human Error.
Cognitive foibles aside, environmental factors frequently come into play. As Heifetz observed, “In most organizations, people feel pressure to solve problems quickly, to move to action. So they minimize the time spent in diagnosis, collecting data, exploring multiple possible interpretations of the situation and alternative potential interventions.” This produces the perfect storm: inherent mental vulnerabilities colliding with situations lacking sufﬁcient curbs or caution.
Humans use mental shortcuts, or heuristics, to make decisions quickly and efﬁciently. Most of the time these serve us well until, unfortunately, Perspective-taking and meaning-making they don’t. And when these shortcuts fail, the So what’s the solution? How can you accurately consequences can be devastating. Take, for distinguish technical problems from adaptive Diagnosis is more fundamental instance, the availability heuristic. This trap challenges, and avoid cognitive traps? Heifetz and abstract than we assume. refers to solutions that pop into our head quickly advocates a now-famous technique that he and easily: tried-and-true approaches, standard calls “getting on the balcony,” “Consider the operating procedures, business as usual. Or a experience of dancing on a dance ﬂoor in contrast cognitive pitfall called anchoring bias, which is with standing on a balcony and watching other the tendency to stick with our impressions and people dance. Engaged in the dance, it is nearly decisions once we have made up our mind. And impossible to get a sense of the patterns made by everyone on the ﬂoor. … yet another, premature closure, involves pursuing a course of action before it To discern the larger patterns on the dance ﬂoor—to see who is dancing has been fully vetted. with whom, in what groups, in what location, and who is sitting out which Brian, as an experienced medical director, was always tinkering with revenue and expenses. He had asked providers to see more patients during revenue slumps in the past and was forever optimizing expenses. The current situation was thus familiar and his solution felt intuitive. The availability heuristic likely caused him to mistake an adaptive challenge for a technical problem. Premature closure and anchoring bias may have contributed, too.
Feature or Need
Locus of control
Authority, experts, leaders
Stakeholders, frontline staff
Deﬁne problems and provide solutions
Identify the adaptive challenge and frame key questions and issues
Shield the organization from external threats
Let the organization feel external pressures within a range it can stand
Clarify roles and responsibilities
Challenge current roles and resist pressure to deﬁne new roles quickly
Expose conﬂict or let it emerge
Challenge unproductive norms
Figure 1. Symptoms and signs characteristic of technical problems and adaptive challenges. Source: Ronald Heifetz, MD (used with permission)
kind of dance—we have to stop moving and get to the balcony.” The balcony is a physical metaphor for mental perspective. We need to create separation, somehow distance ourselves from the scrum of business life, in order to see the so-called “big picture.” Adaptive challenges will never Change management to page 42
Healthcare Planning and Design
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MINNESOTA PHYSICIAN AUGUST 2017
The Minnesota Adult Abuse Reporting Center from cover Preventing abuse and neglect
report suspected maltreatment of a vulnerable adult anywhere in Minnesota. It’s now easier to report maltreatment in Minnesota. And people are using these tools to involve authorities when they suspect maltreatment. MAARC currently receives about 1,000 reports of suspected maltreatment each week.
Unfortunate cases like this one motivate us at the Minnesota Department of Human Services (DHS), as we focus on preventing abuse, neglect, and ﬁnancial exploitation of vulnerable adults. As our population as a whole becomes older, we are stepping up our efforts to monitor and manage long-term care in homes and By 2020, older Minnesotans other community settings, as more of us receive will outnumber school-age this care outside of institutions.
children for the ﬁrst time
MAARC’s hotline replaced the previous system of more than 169 phone numbers designated by counties throughout Minnesota. MAARC also provides an online portal where people who are required to report maltreatment—mandated reporters including physicians and other health care providers, social services workers, educators, law enforcement ofﬁcers, and other licensed professionals—can make reports. (Mandated reporters can also use the toll-free number.)
By 2020, older Minnesotans will outnumber in our state’s history. school-age children for the ﬁrst time in our state’s history. By 2030, one in ﬁve Minnesotans will be over age 65. Anticipating these changes, we have Many vulnerable adults are reluctant to report worked for the past several years on strategies maltreatment. When asked about it directly, to promote choice, independent living, quality they may even deny that they have been harmed. Maltreatment can occur services, and safety for older adults. Strengthening adult protection has been anywhere, from a person’s own home to a nursing home or another place among our priorities as more and more older adults live more independently where a vulnerable adult receives services or spends time. than ever before, often without regular observation and oversight from Many of us will be considered vulnerable adults at points in our lives family members or other caregivers. simply by virtue of receiving care in a particular setting. People in hospitals, Reporting maltreatment nursing homes, transitional care units, assisted living, housing with services, The Minnesota Adult Abuse Reporting Center (MAARC) is a key part of this board and care, foster care, and other licensed care facilities are considered effort. MAARC’s launch in 2015 was a milestone, with a single toll-free number vulnerable adults. So are adults who receive services such as home care, day (1-844-880-1574) available 24 hours a day, seven days a week, for anyone to services, personal care assistance, or other licensed services.
AUGUST 2017 MINNESOTA PHYSICIAN
Maltreatment can take many forms, including abuse, neglect, and ﬁnancial exploitation. Abuse can be physical, emotional, sexual, or verbal; signs can include bruises, black eyes, or broken bones, but also less immediately obvious changes in mental functioning or unexplained behavior. Neglect—failure to provide food, shelter, clothing, health care, or supervision—may be happening if a person is suffering from dehydration, weight loss, poor hygiene, repeated falls, or isolation. Financial exploitation can be involved if bills are going unpaid, if someone is being asked to sign unfamiliar documents, or if things like cash, credit cards, or jewelry are missing.
Of these reports:
What happens after a report?
• County social services agencies received more than 23,000 reports, including reports involving no licensed services and vulnerable adults receiving services from personal care assistance provider organizations, which are not licensed.
When someone reports suspected maltreatment of a vulnerable adult, MAARC assesses the report for immediate risks, makes all necessary referrals, and promptly submits reports to the appropriate investigative agency, which may be the county, Minnesota Department of Health (MDH), or DHS. Reports alleging criminal activity are also forwarded to law enforcement. The identity of the person who made the report remains protected.
An increase in reports In its ﬁrst year of operation ending in mid-2016, MAARC received more than 51,000 reports of suspected maltreatment, up 33 percent from the previous year. The most common allegations were caregiver neglect and self-neglect. Allegations also included ﬁnancial exploitation, by people with or without a ﬁduciary relationship such as power of attorney; emotional or mental abuse; physical abuse; and sexual abuse.
• MDH received more than 22,500 reports in facilities licensed as hospitals, home care providers, nursing homes, residential care homes, and boarding care homes. • DHS received more than 5,700 reports in programs licensed as adult day care and adult foster care and programs serving people with developmental disabilities, mental illness, and substance abuse.
While it’s not clear what drove people to make more reports of maltreatment, we believe two factors may be relevant. For one, MAARC made it easier to report maltreatment, including for mandated reporters. And our public awareness campaign, “The Power of Could,” has highlighted MAARC through social and print media and radio advertising. We aim to make people more aware of maltreatment by showing possible signs, such as a bruise on a person’s face, poor hygiene, unpaid bills, or sudden changes in wills—signs that “could be nothing” or “could be maltreatment.” We emphasized the power of reporting The Minnesota Adult Abuse Reporting Center to page 40
RESOURCES Minnesota Adult Abuse Reporting Center: 1-844-880-1574 http://mn.gov/dhs/reportadultabuse Senior LinkAge Line: The Minnesota Board on Aging’s free statewide information and assistance service. 1-800-333-2433 www.seniorlinkageline.com Disability Linkage Line: An information and referral service for people with disabilities. 1-866-333-2466 www.mcil-mn.org/programs/disability-linkage-line The Minnesota Nursing Home Report Card: Shows how Minnesota nursing homes score on eight quality measures, including resident quality of life and family satisfaction. nhreportcard.dhs.mn.gov The Ofﬁce of Ombudsman for Long-Term Care: A program of the Minnesota Board on Aging. Regional ombudsmen and volunteers work to enhance the quality of life and services for people receiving long-term services and supports. The program also advocates for reform in long-term care through changes in state law, federal law, and administrative policy. https://mn.gov/dhs/people-we-serve/seniors/services/ombudsman/ More resources are available at MinnesotaHelp.info: https://www.minnesotahelp.info/
MINNESOTA PHYSICIAN AUGUST 2017
R E C OG N I T I ON By Richard Ericson
edical research in Minnesota has a long history of excellence, from ﬁrsts in open-heart surgery and bone marrow transplantation to reknowned physician researchers such as C. Walton Lillehei, Owen H. Wangensteen, and Robert A. Good.
Minnesota Physician Publishing periodically presents this feature, which recognizes the hard work and quality outcomes of physicianled medical research in our state. We regret that we cannot highlight every entry, and thank everyone who participated in the nomination process and in compiling and writing the project descriptions.
Today, innovative and dedicated researchers working in academic institutions, urban and rural clinics, managed-care companies, Congratulations to the physician investigators listed here and to all health system foundations, and medical professional societies of Minnesota’s medical researchers for the distinctive standing their research holds in our community. continue to advance our knowledge of medical care.
Oncology The Prostate Cancer Intervention Versus Observation Trial (PIVOT) Research site: Minneapolis VA Health Care System and the Center for Chronic Disease Outcomes Research Principal Investigator: Timothy J. Wilt, MD, MPH Funding: Department of Veterans Affairs; the National Cancer Institute; and the Agency for Healthcare Research and Quality
hile early surgical or radiation treatments for prostate cancer have curative potential, they may not be needed in many men and may not be effective in others. The Prostate Cancer Intervention Versus Observation Trial (PIVOT), a randomized trial in 731 men with localized prostate cancer from the Department of Veterans Affairs and National Cancer Institute medical centers, studied the comparative effectiveness and harms of surgery versus observation.
reduced disease progression and additional treatments, most for local or asymptomatic biochemical (PSA) progression, where the beneﬁts of treatment are not well known. Recommendations: Physicians can use these ﬁndings from PIVOT and other recent studies to conﬁdently recommend observation or PSA-based active monitoring as the preferred treatment option for most men with PSA-detected early prostate cancer. This treatment approach results in similar overall and cancer survival and avoids early treatment adverse effects, as well as harms due to surveillance prostate biopsies and delayed surgical or radiation interventions that occur with active surveillance.
Results: PIVOT found that surgery did not signiﬁcantly reduce all-cause or prostate cancer mortality compared to observation. Cancer mortality was very While surgery and radiation Timothy J. Wilt, MD, MPH uncommon in men with low-risk may have an important role in very disease treated with observation. young men or men with higher risk Surgery led to perioperative harms and more treatment- disease, newer pharmacological options for advanced related bother, physical discomfort, limitations in disease demonstrating substantial survival beneﬁts activities of daily living, and substantially greater long- with tolerable side effects reduce the imperative for term urinary, erectile, and sexual dysfunction. Surgery early treatment.
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hronic obstructive pulmonary disease (COPD) has multiple disease phenotypes and the mechanisms responsible for this heterogeneity are poorly understood. Inﬂammation in response to the COPD lung microbiota is one potential mechanism by which some patients suffer frequent exacerbations and others do not.
Evaluation of the Oral and Lung Microbiota and Inﬂammation in Chronic Obstructive Pulmonary Disease Frequent Exacerbators Research site: Minneapolis VA Medical Center Principal Investigators: Alexa A. Pragman, MD, PhD; Chris H. Wendt, MD; and James R. Johnson, MD Funding: Supported in part by a Career Development Award from the U.S. Department of Veterans Affairs Clinical Science Research and Development Service; the National Institutes of Health Clinical and Translational Science Award at the University of Minnesota; the National Institute of Allergy and Infectious Diseases; the American Lung Association Biomedical Research Grant; and the Minnesota Veterans Medical Research & Education Foundation.
also serve as targets for new COPD therapies. Both aims will utilize advanced biostatistical tools, which will allow her to correlate speciﬁc features of the lung microbiota with lung inﬂammation. Objectives and goals: The overall objective in the proposed project is to determine key features that
Methods: In Aim 1 of this Career Development Award-2 study, Dr. Pragman will identify patients undergoing clinically indicated lung lobectomy and sample their oral, nasal, sputum, and lung tissue microbiota in a manner that avoids upper airway contamination. This study will identify a method for accurate, Alexa A. Pragman, Chris H. Wendt, MD James R. Johnson, MD non-invasive sampling of the lung MD, PhD microbiota. This work will deﬁne the microbiota of the COPD lung and the healthy lung without upper airway contamination, differentiate the upper airway and lung microbiota of and will establish a non-invasive technique for studying COPD patients with a frequent exacerbator phenotype the lung microbiota. In Aim 2, Dr. Pragman will conduct from those with the infrequent exacerbator phenotype. Dr. a prospective study comparing the lung microbiota and Pragman’s long-term goal is to understand the role of the lung inﬂammatory biomarkers of frequent exacerbators lung microbiota in the pathogenesis of inﬂammatory lung to infrequent exacerbators. She will identify speciﬁc disorders. This work will form the basis for further clinical and co-varying microbiota and sputum inﬂammatory translational research to establish the mechanisms by which biomarkers that can identify exacerbation phenotype and the lung microbiota contributes to COPD pathogenesis.
PROVIDING A PEACEFUL PLACE TO REST AND GROW Essentia Health, Fargo, ND—Neonatal Intensive Care Unit
acute care | outpatient care | senior living
www.eapc.net MINNESOTA PHYSICIAN AUGUST 2017
PHYSICIAN RESEARCH RECOGNITION
Oncology The role of tunneling nanotubes in chemoresistance Research site: Lou Lab, University of Minnesota Division of Hematology, Oncology and Transplantation Principal Investigators: Emil Lou, MD, PhD, FACP; Subree Subramanian, PhD; and Clifford J. Steer, MD Funding: Minnesota Masonic Charities; KL2 Scholars Career Development Program (2013–16), Clinical and Translational Science Institute (CTSI), University of Minnesota; Mezin-Koats Colon Cancer Research Award; Randy Shaver Cancer Research & Community Fund; The Litman Family Fund for Cancer Research; National Pancreas Foundation, 2013 Research Grant (provided in partnership with the National Pancreas Foundation, several NPF Chapters, and the Horvitz/Lebovitz Research Fund); American Cancer Society, Institutional Research Grant, University of Minnesota, 2012–13; Powell Center for Women’s Health, Interdisciplinary Seed Grant, University of Minnesota, 2013–14; Courage And A Cure; Minnesota Medical Foundation, Research Grant, 2012–14; Karen Wyckoff Rein in Sarcoma Foundation, Seed Grant, 2012–13; and Baker Street Foundation, 2008–10.
he Lou Lab primarily focuses its work on Methods: Our team was the ﬁrst to studying intercellular communication demonstrate, using confocal microscopy, presence via cellular extensions called tunneling of nanotubes in intact malignant tumors. To date, nanotubes (TNTs), and their potential role we have demonstrated nanotubes in several invasive in cancer cell invasion, tumor recurrence, and malignancies such as mesothelioma and lung the emergence of chemoresistance. TNTs are long, thin, adenocarcinoma from surgically resected tumors spontaneously forming actin-based cellular extensions from human patients [Lou et al., PLoS ONE, that occur in a variety of cell types, including inﬂammatory cells (e.g., B cells, macrophages), neurons, and, more recently, in examinations of malignant cells. When examined in vitro, TNTs are differentiated from other actin-based structures such as ﬁlopodia, invadopodia, and lamellopodia by their characteristic non-adherence to Clifford J. Steer, MD Emil Lou, MD, PhD, FACP Subree Subramanian, PhD the substratum. Furthermore, once they attach to nearby or distant cells in culture, 2012], and more recently in orthotopic animal they form direct connections that serve as conduits for models including osteosarcoma. intercellular transport of a variety of cellular cargo and Outcomes: Our collaborative team believes that contents, including but not limited to lipophilic vesicles, TNTs are an underexplored yet potentially important Golgi vesicles, and even mitochondria. Until recent years, there had been relatively few studies of TNTs in cancer, mode of intercellular communication in cancer and particularly in primary cancer cells or tumors. Much play a heretofore unassessed role in chemoresistance remains unknown about these structures, including their that develops due to tumor-stromal cross-talk in the complex and heterogeneous tumor microenvironment. function and relevance in tumors.
MANY FACES OF COMMUNITY HEALTH 12TH ANNUAL CONFERENCE
Thursday–Friday, October 26-27, 2017 • Hyatt Regency Bloomington, 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.
Keynote Speaker: Jon Hallberg MD and the Hippocrates Café Images of the Underserved Through the Eyes and Voices of Actors and Musicians Hippocrates Cafe is a group of professional actors and musicians who use the arts to explore health care topics. At the Many Faces conference they will focus on health disparities and the safety net. Dr. Halberg is family physician, associate professor at the University of Minnesota Medical School and medical director of Mill City Clinic. He also serves as regular medical commentator on Minnesota Public Radio’s “All Things Considered;” and manages the Fisch Art of Medicine Student Awards, which enables University of Minnesota medical students to explore the arts.
For a complete list of speakers and times, visit the conference web site:
manyfacesconference.org For more information: contact Shelly Losinski at 952-564-3077 or email@example.com
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Immunization Vaccine Safety Datalink Research site: HealthPartners Institute Principal investigators: James D. Nordin, MD, MPH, and Elyse Olshen Kharbanda, MD, MPH Funding: Centers for Disease Control and Prevention
he Vaccine Safety Datalink (VSD) is a multisite network funded by the Centers for Disease Control and Prevention (CDC). A collaboration including several large health care organizations, it conducts post-marketing surveillance of the safety of vaccines currently licensed and in use in the United States. Health Partners Institute joined the VSD in 2000 and continues to participate in ongoing vaccine safety assessments. The VSD team, under the direction of Drs. Nordin and Kharbanda, has been a leader in research on the safety of vaccines given to pregnant women. The team also includes Drs. Gabriela Vazquez-Benitez, Malini DeSilva, Heather Lipkind, Jingyi Zhu, and Ms. Leslie Kuckler.
cellulitis, to preterm birth or major structural defects, Drs. Nordin and Kharbanda have consistently demonstrated the safety of maternal inﬂuenza and Tdap vaccination. Although HPV vaccination in pregnancy is uncommon, their research has also demonstrated that these inadvertent exposures were not harmful for mothers or infants.
Methods: Two vaccines are routinely recommended for pregnant women in the U.S., the inﬂuenza vaccine and Tdap. In addition, the HPV vaccine is recommended for young women of reproductive age, as inadvertent exposures during pregnancy can James D. Nordin, MD, MPH Elyse Olshen Kharbanda, occur. Using data from over 500,000 pregnancies, MD, MPH Drs. Nordin and Kharbanda have described vaccine coverage during pregnancy and evaluated risks for vaccines Outcomes: Dr. Nordin and Kharbanda’s research administered during pregnancy to adversely affect the health ﬁndings have been widely disseminated in peer-reviewed of mothers and infants. journals and presented at national and international meetings, Results: Since 2004, pregnant women in the U.S. including multiple presentations at the Advisory Committee increasingly are receiving inﬂuenza and Tdap vaccines during on Immunization Practices. Their work provides reassurances pregnancy. Across 11 published studies of vaccine safety in for pregnant women and their medical providers, supporting pregnancy, with outcomes ranging from maternal fever or the safety of pregnancy vaccine guidelines.
MINNESOTA PHYSICIAN AUGUST 2017
PHYSICIAN RESEARCH RECOGNITION
Immunotherapy Maximizing Natural Killer Cell Immunotherapy in Ovarian Cancer through Synergy between IL-15 Signaling and PD-1/PD-L1 Checkpoint Blockade Research site: University of Minnesota Principal Investigators: Melissa Geller, MD; Martin Felices, PhD; and Jeff Miller, MD Funding: American Cancer Society; Randy Shaver Cancer Research & Community Fund; and U.S. Department of Defense
varian cancer is the most lethal gynecologic malignancy, and recurrent ovarian cancer cannot be cured with current therapies. Our long-term research objective is to exploit the innate immune system to treat ovarian cancer and to improve survival rates.
immune responses. We now know that trans-presentation of IL-15 is the best physiologic signal to expand NK cells. We are testing an IL-15/IL-15R_-Fc superagonist complex (ALT-803) that provides prolonged cytokine function. ALT-803 enhances NK cell cytotoxicity against ovarian cancer and is able to rescue functionality of NK cells derived from ovarian cancer ascites. Of
Summary: Natural killer (NK) cells exhibit potent anti-tumor activity through cytotoxic function and cytokine release that induce the adaptive immune response, but do not require prior sensitization or HLA-restricted antigen recognition. NK cells in the peritoneal cavity of ovarian cancer patients demonstrate reduced function due to tumor-induced suppression of the peritoneal microenvironment. Our goals Jeff Miller, MD Martin Felices, PhD Melissa Geller, MD are to induce NK cell activation, survival, and expansion in the peritoneal cavity to consequence, however, cytokine signaling induces PD-1 promote NK cell cytotoxicity against ovarian cancer. expression on NK cells and IFN-a, produced by NK One immunosuppressive mechanism in the tumor cells after ALT-803 priming, induces PD-L1 on ovarian microenvironment (TME) is the expression of immune cancer. We hypothesize that although ALT-803 rescues checkpoint molecules: programmed cell death 1 (PD-1) NK cell function and expansion in the ovarian cancer and its ligand PD-L1. PD-1 is expressed on the cell TME initially, it will enhance inhibitory signaling via the surface of activated T, B, and NK cells, and transduces PD-1/PD-L1 axis. We are testing ALT-803 and PD-1/ an inhibitory signal upon ligation with PD-L1/PD-L2, PD-L1 inhibition to optimize immune activation and expressed on cancer cells. This interaction halts anti-tumor anti-tumor activity in a xenograft model.
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Neurology Cerebral Atrophy and the Risks of Chronic Subdural Hematoma Research site: Minneapolis VA Health Care System Principal Investigators: Uzma Samadani, MD, PhD; Abdullah Bin Zahid, MD; and David Balser, MD Funding: U.S. Department of Veterans Affairs Clinical Science Research and Development Program Merit Review Award I01CX000887
hronic subdural hematoma (cSDH), associated with brain atrophy in the elderly, has a 30 percent one-year mortality. Approximately half of afﬂicted subjects report either no or relatively unremarkable trauma preceding diagnosis, raising the possibility that cSDH is a manifestation of degenerative or inﬂammatory disease. Our research seeks to determine the relationship of cSDH to cerebral atrophy using novel neuroimaging segmentation methods developed from previous studies on cerebral atrophy in dementia.
SDH subjects treated surgically did not signiﬁcantly differ. SDH volume was not a signiﬁcant predictor of atrophy rate. Outcomes: We discovered a signiﬁcant trend of increased cerebral atrophy after onset of SDH. This additional aspect of cSDH pathogenesis further explains the tendency of cSDH to recur after treatment, and it
Methods: Focusing on veterans who have undergone at least four headcomputed tomography (CT) scans over a period of 10 years, we analyzed whole brain, cerebrospinal ﬂuid, and intracranial space volumes separately in David Balser, MD Abdullah Bin Zahid, MD Uzma Samadani, MD, PhD subjects with SDH, dementia, or neither. Subgroup analysis of the relationship between SDH volume strengthens the argument that cSDH is associated with and atrophy was also performed in the SDH group. cognitive decline. cSDH treatment might beneﬁt from Results: 962 head CT scans were analyzed in 146 veterans. 45 had dementia, 28 had SDH, and 73 did not have either condition. 17 of the SDH subjects were further analyzed. Post-bleed brain atrophy as a percentage of the cranial cavity in SDH subjects was signiﬁcantly increased compared to both subjects that developed dementia, and neither diagnosis. Subgroup analysis of atrophy rates in
an increased focus on the assessment of cognition. This clinical ﬁnding may also play a role in the continuing effort to determine the pathogenesis of atrophy from different etiologies. Automated image processing will facilitate discovery of other atrophy-associated conditions and improve both clinical management as well as the understanding of neurodegenerative disease.
MINNESOTA PHYSICIAN AUGUST 2017
PHYSICIAN RESEARCH RECOGNITION
Oncology Safety and Efﬁcacy Study of Pembrolizumab (MK3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475564/KEYNOTE-564) Research site: Minnesota Oncology Specialist, PA (Site 8002) Principal Investigators: Samith Kochuparambil, MD, and Tim Larson, MD Funding: Merck Sharp & Dohme Corp.
he purpose of this study is to evaluate the safety and efﬁcacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to disease-free survival (DFS) as assessed by the investigator in male and female participants with intermediate-high risk, high risk, and M1 NED RCC.
Detailed Description: Participants will be assigned to receive study treatment until disease recurrence, unacceptable adverse events (AEs), intercurrent illness that prevents further administration of treatment, investigator’s decision to withdraw the participant, noncompliance with study Samith Kochuparambil, MD Tim Larson, MD treatment or procedural requirements, administrative reasons requiring cessation of treatment, or until Secondary Outcome Measures: Space limitations the participant has received 17 cycles of study treatment prohibit a full listing of secondary outcome measures. (approximately 1 year). Each cycle is 3 weeks long. Primary Outcome Measures: Disease-free survival (DFS) as assessed by the investigator [time frame: up to approximately 72 months].
DFS, as assessed by the investigator, is deﬁned as the time from randomization to the ﬁrst documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs ﬁrst.
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For a complete listing of secondary outcome measures, as well as additional details about this study, visit http:// tinyurl.com/MP-ResearchAwards.
Oncology Assessing the effect of glucobrassicin-rich Brussels sprouts on the metabolism of deuterated phenanthrene: developing food-based chemoprevention of tobacco-related lung cancer. Research site: University of Minnesota Principal Investigators: Naomi Fujioka, MD; Stephen Hecht, PhD; and Dorothy Hatsukami, PhD Funding: Masonic Cancer Center (internal grant)
his clinical research study examines whether eating Brussels sprouts, which contain a compound called indole-3-carbinol (and its derivative, 3,3´-diindolylmethane), can change the way a smoker processes carcinogens in tobacco. If so, this project would represent further development of our long-term goal of developing foodbased chemoprevention strategies against smoking-related lung cancer.
Primary Outcome Measures: Change in [D10] phenanthrene tetraol (time frame: 7 days). Compare level of urinary [D10]phenanthrene tetraol before and after 7 days of Brussels sprouts consumption. Secondary Outcome Measures: Change in [D10] phenanthrols (time frame: 7 days). Compare level of
Description: Subjects will be given 1 microgram of [D10]phe, and all urine will be collected for 6 hours afterwards to quantify baseline levels of [D10] phenanthrene tetraol ([D10]pheT) and [D10]phenanthrols ([D10]HOP). Within 3 days of this baseline measurement, subjects will consume 200 micromoles of Stephen Hecht, PhD Dorothy Hatsukami, PhD Naomi Fujioka, MD glucobrassicin in the form of raw Brussels sprouts (~150 grams) at the study center once daily for 7 consecutive days. Urine will be collected for urinary [D10]phenanthrene phenanthrols before and 24 hours after vegetable consumption on days 3 ± 1 and 6 after 7 days of Brussels sprouts consumption. of the feeding intervention for 3,3’-diindolylmethane (DIM) Change in [D10]phenanthrene tetraol:[D10] quantiﬁcation. On day 7 of the feeding intervention, a second dose of 1 microgram of [D10]phe will be administered at phenanthrol ratio (time frame: 7 days). Compare level the study center after vegetable consumption, followed by of urinary [D10]phenanthrene phenanthrols before and another 6 hours of urine collection. after 7 days of Brussels sprouts consumption.
MINNESOTA PHYSICIAN AUGUST 2017
PROFESSIONAL UPDATE: ONCOLOGY
The ﬁnancial toll of cancer therapy Developing ways to help the patient BY PAMALA A. PAWLOSKI, PHARMD; HEATHER KEHN, BS, RN, MPH; AND DANIEL M. ANDERSON, MD
ncology care teams in our community know the personal ﬁnancial toll that cancer has on patients and their families. It is a salient topic. Our oncologists and cancer center staff frequently see patients in clinic struggling with ﬁnances and making tough decisions as a result and we know more has to be done. It has been shown that more than 30 percent of families of seriously ill patients report losing most or all of their family’s savings (Covinsky et al., JAMA, 1994). This is likely more burdensome for cancer patients because the out-of-pocket costs associated with cancer care are higher compared with other conditions. Patients with cancer who report a ﬁnancial burden as a result of cancer care costs are signiﬁcantly less likely to rate their quality of life positively (Fenn et al., Journal of Oncology Practice, 2014). Among patients with cancer, it has been shown that 8 percent forego medical care and 10 percent avoid ﬁlling prescription medications due to the costs of care (Weaver et al., Cancer, 2010). It is because of the cancer-related out-of-pocket expenses that 42 percent of patients experience a major ﬁnancial burden and 20 percent
are non-adherent to medications to save money (Zafar et al., Oncologist, 2013). Cancer survivors who experience the greatest ﬁnancial hardship are those in the working-age population (Yabroff et al., Journal of Clinical Oncology, 2016). After studying the quality of cancer care in 2013, the Institute of Medicine (IOM) determined that the system of cancer care is in crisis. The rising cost of cancer care is one of the primary barriers to achieving excellent care for all cancer patients. In 2016, the Association of Community Cancer Centers Trends in Cancer Programs Survey found the cost of cancer drugs was named the top challenge by 83 percent of respondents up from 45 percent in the prior year. Further, the American Cancer Society Action Network found that cancer patients often face high costs associated with their care despite having health insurance. Those costs are attributed to high co-insurance or deductibles, the need for outof-network care, and treatments that are not covered by their health plan. Given the statistics, there is a critical need to ﬁnd ways to better prepare patients starting cancer treatment.
Study details To fully understand the personal ﬁnancial toll cancer can have on patients, the Metro-Minnesota Community Oncology Research Consortium (MMCORC) is participating in a National Cancer Institute-funded study: S1417CD “Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer” (study chair, Veena Shankaran, MD). Over the next three years, investigators from 174 institutions across the U.S. are planning to recruit 350 adult patients who have newly diagnosed metastatic colon or rectal cancer. Patients to consider for this clinical trial include those who are within 120 days from diagnosis. An eligible participant needs to be within 60 days from initiation of systemic chemotherapy or biologic therapy, or plan to initiate their therapy within 30 days of study registration. This study is designed to estimate the incidence of treatment-related major ﬁnancial hardship over 12 months through questionnaires taken at baseline and every three months. Patients will be asked speciﬁc questions about how cancer care has affected their ﬁnancial situation. Additional outcomes include the assessment of whether the major ﬁnancial hardship is associated with poorer health-related quality of life over time; to assess the magnitude and timing of treatment-related changes in patients’ income, assets, debt, and employment, and to quantify major out-of-pocket expenses during the 12 months following study enrollment; and to explore the extent to which health insurance factors (e.g., high copayments, deductibles, premiums, loss/change of insurance plan) are associated with major ﬁnancial hardship and treatment non-adherence. This study will enable the systematic evaluation of the ﬁnancial impact colorectal cancer has on patients and will estimate the incidence of cancer treatment-related ﬁnancial hardship. The ultimate goal of this research is to measure the association between cancer treatment and ﬁnancial hardship, using a comprehensive ﬁnancial impact assessment tool that can be adopted in routine clinical care and alongside cooperative group clinical trials. The S1417CD protocol looks at knowledge and preparation for the patient as an outcome, and does not solely target prescription costs or insurance. By developing a system to
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as well as develop and test promising interventions within the health care track treatment-related ﬁnancial changes over time and by improving our delivery system. It also supports development of new and generalizable understanding of the major risk factors for ﬁnancial hardship, we hope to knowledge about the effectiveness, acceptability, cost, optimal delivery deﬁne the measurable impact of cancer on patient ﬁnances. This would lay mode, and causal mechanisms that inﬂuence important groundwork to establish interventions outcomes and affect the value of cancer care across that can complement the medical oncologist’s diverse settings and populations. The goal of role in treating cancer patients and help patients CCDR is evidence-based practice transformation. avoid major ﬁnancial strain. Interventions such Integrating CCDR into NCORP provides as comprehensive ﬁnancial counseling, advanced The out-of-pocket costs associated the ability to collect primary data and initiate planning for patient drug assistance programs, and with cancer care are higher interventions across a mix of practice models tools to inform physicians about potential high compared with other conditions. and heterogeneous populations. It also enables copayments could help lessen patients’ treatmentthe study of patients from the time of diagnosis related ﬁnancial burden. The NCI Community through treatment and survivorship. Oncology Research Program (NCORP) represents a unique mechanism to accrue patients being treated in community clinical settings to cancer Pamala A. Pawloski, PharmD, is a research investigator at HealthPartners care delivery research studies.
Study sites Local MMCORC study sites include: Abbott Northwestern Hospital, Fairview Ridges (MN Oncology-Burnsville), HealthPartners Riverside Cancer Care Center; Hennepin County Medical Center; Lakeview Hospital Cancer Care; Minnesota Oncology & Ridgeview Cancer & Infusion Center; Park Nicollet Frauenshuh Cancer Center; Regions Hospital Cancer Care Center; Rice Memorial Hospital; United Hospital; and Westﬁelds Hospital Cancer Center of Western Wisconsin. Our investigators work closely with community partners to understand the needs of the community. Thus, an important part of the local implementation process for this study is working with community programs and advocacy networks to understand what patients are experiencing and how best to discuss this sensitive topic with patients. Potential study participants can call Metro-Minnesota Community Oncology Research Consortium at (952) 993-1517 to learn more about participating in this research study.
Institute, lead investigator for Cancer Care Delivery Research (CCDR) within MMCORC, and the local site principal investigator.
Heather Kehn, BS, RN, MPH, is a program manager at MMCORC and the local CCDR Lead.
Daniel M. Anderson, MD, is an oncologist at Regions Hospital Cancer Care Center and the principal investigator of the MMCORC.
Involving the community oncologist MMCORC is a nonproﬁt research program sponsored by the NCI Community Oncology Research Program (NCORP; https://ncorp.cancer. gov/about/). Through clinical trials, this program provides access to the newest therapies available for cancer treatment, management of treatmentrelated side effects and disease symptoms, and cancer prevention. The overall goal of NCORP is to bring cancer clinical trials (cancer control, prevention, screening, treatment, imaging, and cancer care delivery) to individuals in their own communities where the majority of cancer patients receive their treatment. There is tremendous beneﬁt from the dispersion of clinical trials to the community where patients are able to remain under the care and expertise of their community oncologist. Further, the involvement of the community oncologist in the development and implementation of national research enhances study accrual and generalizability; contributing to improved patient outcomes and a reduction in cancer disparities. For more information, please visit http://www.ccopnet.com/
The importance of CCDR Cancer Care Delivery Research (CCDR, https://healthcaredelivery.cancer. gov/ccdr/) is a relatively new area of research within NCORP. It is a multidisciplinary science that examines how patient and clinician behavior, organizational structures, health technologies, and ﬁnancing approaches inﬂuence the availability, quality, cost, and outcomes of cancer care. CCDR generates evidence that can be used to improve clinical practice patterns MINNESOTA PHYSICIAN AUGUST 2017
HEALTH CARE REFORM
The Future of Health Care initiative Creating value-based partnerships BY GARRETT BLACK
dvancing health care value is about ensuring a more affordable and sustainable health care system for everyone—and making a healthy difference in people’s lives. American health care leads the world in many respects, but our system is very expensive compared to other countries, and many countries produce better results. Minnesota has a long history and strong reputation for being a progressive state where health care innovation thrives. We need that same spirit of innovation and collaboration to advance new ideas and approaches to health care ﬁnancing and care delivery. But who is really responsible for the cost of health care? The reality is that we’ll need everyone working together if these cost challenges are to be met. These challenges are driven by multiple factors: an aging population; a volume, not valuebased payment system; fragmented information that hinders care coordination and complicates care consumption decisions; skyrocketing pharmacy costs; and continuing issues of waste and unnecessary utilization of services. Having been in leadership positions in both provider and payer organizations, it is not possible for providers and payers to solve the many challenges facing the
AUGUST 2017 MINNESOTA PHYSICIAN
American health care system by working in silos. We must partner across the health care community on new ideas and approaches to advance the future of health care.
Partnering for change With physicians on the front lines of care delivery, more physicians need to be aware and engaged in addressing the costs as well as the outcomes of the care they administer. Doctors decide which tests and treatments are needed, where they will be delivered, and which drugs will be prescribed. Doctors should always make these decisions based on what is best for their patients. Consumers are paying more of their own money directly for health care with the growth of high-deductible health plans and ever-rising insurance premiums. In a value-based model, consumers pay for optimal health and care management, not just visits, tests, or procedures—and costs tend to be more stable and predictable over time. But to do that, health plans and doctors need to help consumers assess and judge the health value and cost beneﬁt of various choices, so they can make the best decisions for themselves and their family. To achieve that, there must be more transparency.
Alternative payment models Modern Healthcare magazine recently surveyed health care CEOs about alternative
payment models. About half of the respondents said less than 5 percent of their revenue is currently tied to alternative payment models. Within two to ﬁve years, nearly 40 percent of the CEOs expect more than 25 percent of their revenue to be tied to different types of value-based payments such as bundled services payments, accountable care organizations, medical homes, and population health initiatives, according to the survey. The survey also reveals that, “The push toward value-based payment models has caused providers to make larger investments in information technology, improve coordination across the continuum and deliver better outcomes at lower costs.” Ultimately, value-based payment reform translates to reduced variation in outcomes, the elimination of unnecessary tests and procedures, and managing a patient’s total health.
status; notiﬁcations of patient admission, discharge and treatment; care summaries; and care coordination among unafﬁliated providers.
Minnesota may be better served by adopting a more structured and standardized approach to govern and facilitate the exchange of HIE data across providers, payers, and other important stakeholders such as behavioral health, long-term care, and social services providers. Payers play a critical role as well. Our newly announced “Future of Health Care” initiative, highlights ideas that Blue Cross and Blue Enhancing the HIE in Shield of Minnesota is putting in motion to address Minnesota is vital to improving this challenge in Minnesota and beyond.
Studying Minnesota’s HIE The Minnesota Legislature has commissioned a study (due in February of 2018) to assess Minnesota’s framework for the Health Information Exchange (HIE) and to make recommendations for modiﬁcations that would strengthen the ability of Minnesota’s health care providers to securely exchange data, in compliance with patient preferences, in a way that is efﬁcient and ﬁnancially sustainable. Enhancing the HIE in Minnesota is vital to improving transparency, the efﬁciency of care delivery, and improving population health. The HIE can greatly advance population health and care coordination by making it easy for providers and payers of care and social services agencies to share basic, but vital information such as immunization
A new initiative
In recent years, we have focused on growing valuebased provider reimbursement by working with doctors and hospitals who share our desire to transform health care. Our new “Future of Health Care” initiative expands that partnership to include new models of collaboration and navigation support for our members. This important new effort focuses on three strategic areas: 1) clinical innovation, 2) care management, and 3) network and payment. Clinical innovation In clinical innovation, we have leveraged ideas such as the Mayo Clinic Living-Donor Kidney Program. We recently worked with Mayo and local employers to launch this new program, creating “donor chains.” If someone
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The Future of Health Care initiative to page 38
tŚĞŶ ƚŚĞƌĞ ĂƌĞ ŶŽ ƐŝŐŶƐ Žƌ ƐǇŵƉƚŽŵƐ͕ ǇŽƵ ŵĂǇ ŶŽƚ ŬŶŽǁ ƵŶƟů ŝƚ͛Ɛ ƚŽŽ ůĂƚĞ͘ Đƚ ŶŽǁ͘ ^ĐƌĞĞŶ ǇŽƵƌ ƉĂƟĞŶƚƐ ĨŽƌ ƚǇƉĞ Ϯ ĚŝĂďĞƚĞƐ͘ /ƚ͛Ɛ ĞĂƐǇ͘ /ƚ͛Ɛ ĐŽǀĞƌĞĚ͘ /ƚ ǁŝůů ƌĞĚƵĐĞ ƚŚĞŝƌ ƌŝƐŬ͘ ͻ ZĞĨĞƌ ǇŽƵƌ ĂƚͲƌŝƐŬ ƉĂƟĞŶƚƐ ƚŽ Ă ƉƌŽǀĞŶ ůŝĨĞƐƚǇůĞ ĐŚĂŶŐĞ ƉƌŽŐƌĂŵ ĂŶĚ ŚĞůƉ ĐƵƚ ƚŚĞŝƌ ƌŝƐŬ ŽĨ ĚĞǀĞůŽƉŝŶŐ ƚǇƉĞ Ϯ ĚŝĂďĞƚĞƐ ŝŶ ŚĂůĨ͘
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MINNESOTA PHYSICIAN AUGUST 2017
Minnesota Health Records Act Efforts to improve a challenging process BY BOB JOHNSON, MPP, AND DIANE RYDRYCH, MA
innesota is a national leader in e-health; all hospitals and nearly all clinics in the state have adopted and are using electronic health records (EHRs). In order to effectively use the wealth of information contained in these systems to improve health outcomes, patients must be able to have conﬁdence in the integrity of the data being shared, and trust that the providers using the data have the proper procedures in place to keep their information safe, secure, and protected from unauthorized access. Though at times complex, these administrative, technical, and physical safeguards, together with sound policies, procedures, and practices for effectively using technology to deliver patient care, create a framework in which patient conﬁdence and trust will grow, and the meaningful exchange of health information can take place. In Minnesota, the primary laws and regulations affecting consent for the release of health information are the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations in the Privacy Rule, and the Minnesota Health Records Act (MHRA).
HIPAA’s Privacy Rule requires patient consent for certain disclosures of protected health information (PHI) but it does not require consent when the disclosure is for the patient’s treatment, for payment for that treatment, or for health care operations purposes. In contrast, the MHRA requires patient consent when a health care provider discloses an individual’s health records for treatment, payment, or health care operations and for most other releases, with limited exceptions. The inconsistencies between HIPAA’s Privacy Rule and the MHRA have sometimes resulted in confusion and even misunderstanding among patients and providers when it comes to the appropriate sharing of health information.
The impacts and costs of the MHRA In 2016, in response to a recommendation by the Governor’s Health Care Financing Task Force to update the MHRA and conform its requirements with HIPAA, the Minnesota Legislature directed MDH to solicit feedback from patients and providers on the costs and patient impacts associated with the consent requirements included in the MHRA (Minnesota Session Laws 2016, Regular Session, Chapter 189, article 20, section 5). In compliance with the Legislature’s charge, the Minnesota Department of Health issued a Request for Information (RFI) in September 2016 to receive formal comments about the MHRA’s consent requirements from the community. After receiving and analyzing nearly 90 responses, the Department issued a report in February 2017 describing key themes from the information provided by patients and health care providers through the RFI process. The report titled, “Impacts and Costs of the Minnesota Health Records Act” groups the responses into two sections, one from individual patients and organizations that represent them and one from providers. It includes detailed comments selected from the responses that support the themes that emerged in the analysis. (You can download the report at http://www.health.state. mn.us/e-health/legrpt/index.html.)
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Among the patient responses, there was not a consensus on the positive or negative impact of the MHRA’s consent requirements. However, from the responses, it was clear that those who indicated that they (or those they care for) have complex health care needs wanted a smoother, more efﬁcient information sharing process. There were many comments from individuals about receiving unnecessary, redundant, or duplicative tests or having to re-tell their story every time they saw a new provider. It was also difﬁcult to quantify the patients’ experience related to cost, and the responses showed that patients have varied experiences relating to the cost of providing consent for sharing their personal health information and varied opinions on how their personal health information should be controlled and used.
Providers Health care providers and payers that responded to the RFI were much more consistent in their views about the MHRA’s consent requirements. Individual providers and provider organizations that responded indicated
consensus that the MHRA has a negative impact on patients relating to: interrupted care coordination; duplicative labs, test and imaging; delays in care; signing many forms; and in general going against patient expectations that providers routinely share relevant health information with the patient’s other providers for treatment and care coordination purposes. Providers also reported that there are costs and confusion associated with managing the MHRA’s consent requirements. Costs are varied, and not all could calculate the costs other than to point out that the requirements take time and attention away from patient care. Providers reported that the vast majority of patients (>95 percent) provide consent to share their information, and processes to obtain consent vary widely.
Report ﬁndings The range of RFI responses from a patient/individual and a health care provider perspective suggest a number of considerations and implications for lawmakers as they weigh options related to the MHRA and its consent requirements. In addition, the RFI identiﬁed several broader themes that are interrelated to the questions of impact or cost associated with the MHRA and relevant to the process of providing patient care. The following considerations were reviewed and endorsed by the Minnesota e-Health Initiative’s Advisory Committee, part of a publicprivate partnership that has developed key e-health policy recommendations for over the past decade: 1. The MHRA does not adequately support the majority of patients whose preference, as reported by providers, is to share their health information to ensure they receive the appropriate care. While MHRA supports patients who do not want to share their personal health information, information from providers indicates that these patients represent a very small percentage of all patients. Providers report that the vast majority of patients consent to have their information shared, and responses from patients to the RFI indicate a mix of preferences. In practice, the MHRA inhibits the ability of those who want their information to be shared to do so easily. Future statutory approaches should more easily enable information sharing for patients who prefer that their information be shared, using a simpliﬁed process, and enabling patients to better understand their conﬁdentiality rights.
very few to support MHRA. In addition to resources to support MHRA, it is equally important that providers develop a more common understanding of speciﬁc provisions of HIPAA, including requirements for treatment, payment, and health care operations as well as security requirements. 4. Education and resources are needed by patients. In addition to providers, patients are often uncertain, misinformed, or confused about information such as: • What rights they have regarding the disclosure of their information to providers, payers, and others. • How their information is typically used and accessed in a health care setting, and how to understand an audit trail regarding access to their information. • The security protections that are in place to keep their information conﬁdential. 5. Implementing MHRA often requires a manual (work-around) process for obtaining patient consent outside of the electronic health record system digital workﬂow. This implies more resources are needed for implementation of customized systems that are MHRA-compliant. Because the work-around process requires more staff time/resources, many of which are hidden costs built into workﬂows, fewer resources are available for patient care. Providers that have the resources to try to electronically implement the process face expensive technology updates. Minnesota Health Records Act to page 36
2. If the consent requirements of the MHRA remain in place, some clariﬁcations to operationalize the current MHRA intentions are needed. The responses to the RFI demonstrated a signiﬁcant variation in the way that the consent requirements of the Minnesota Health Records Act are being implemented, indicating different interpretations of the law. Other, more extensive work of the Minnesota e-Health Initiative supports this conclusion. Suggested updates include: • Clarifying that consent does not require a wet-pen signature and that an electronic signature should be allowed. • Specifying how long a patient’s consent to share information remains in place before expiring. • Using common language and deﬁnitions regarding health information exchange, compared to Minnesota’s HIE Oversight law (Minnesota Statutes §§62J.498-4982). 3. Education, resources, and legal assistance related to the MHRA are needed by providers, especially providers in smaller practices. In addition to clariﬁcations within the law itself, training, resources, and legal assistance are needed to help providers have a common understanding of the law and processes for implementation. Providers have many resources to support HIPAA, but MINNESOTA PHYSICIAN AUGUST 2017
Minnesota Health Records Act from page 35 6. It will be difﬁcult for Minnesota to achieve its goals related to coordination of care for complex patients, improved quality of care, and cost savings due to varied interpretations of the consent requirements in the MHRA. The aims of accountable care organizations (ACOs), Integrated Health Partnerships (Minnesota Medicaid ACOs), and other health care payment and delivery reform models (e.g., health care homes) are to lower costs while improving care and outcomes. Care coordination, including sharing relevant patient information among appropriate providers, is necessary to achieve these goals. Future statutory changes should realize the potential of ACOs, health care homes, and other reform efforts to improve health care in Minnesota.
Next steps and resources MDH has already worked to develop resources, guidance, and tools to help providers bolster their privacy and security compliance programs, and to meet some of the educational resource needs identiﬁed in the MHRA study. State funded resources include: Minnesota’s Standard Consent Form to Release Health Information, a Minnesota Model Notice of Privacy Practices (NPP), and additional pieces on proactive monitoring procedures, risk analysis, and psychotherapy notes in Minnesota. Most recently, MDH funded work by Gray, Plant, Mooty (GPM) in which the Minneapolis law ﬁrm developed a “Foundations in Privacy Toolkit” to help providers implement policies and procedures that are compliant with both HIPAA and Minnesota-speciﬁc consent laws and that will better enable the appropriate safe and legal sharing of protected health information. The toolkit contains the following types of material, organized by subject area: • Template policies and procedures • Decision tree ﬂow charts • Template agreements • Checklists for compliance These resources should enable providers of all types to feel more conﬁdent in their ability to meet the requirements of both state and federal laws associated with patient consent for exchange of health information. The toolkit and other health information privacy resources developed or funded by MDH are available at http://www.health.state.mn.us/e-health/privacy/index.html. The report on the Impacts and Costs of the Minnesota Health Records Act is also helping to provide important input into a larger legislative study that the Minnesota Department of Health is currently conducting to better understand whether the legal, ﬁnancial, and regulatory frameworks for health information exchange in Minnesota serve as barriers to statewide interoperability. The study includes taking a more in-depth look at the requirements in the Minnesota Health Records Act, as well as making recommendations for a broader range of modiﬁcations to Minnesota’s health information exchange model that would strengthen the ability of Minnesota health care providers to securely exchange data in compliance with patient preferences and in a way that is efﬁcient and ﬁnancially sustainable. MDH will continue to gather information throughout the coming months as it prepares a written report to be submitted to the Minnesota Legislature in February 2018. Hearing from health care providers, payers, patients, and other stakeholders as the recommendations evolve will be critically important for developing a model that meets community needs and provides value to users. Stakeholders will have a number of opportunities to provide input into the study, at community forums and through other mechanisms. For more information about the study, and to learn about opportunities to provide input, visit http:// www.health.state.mn.us/e-health/.
Bob Johnson, MPP, is a policy analyst with the Minnesota Department of Health’s Ofﬁce of Health Information Technology.
Diane Rydrych, MA, is the director of the Division of Health Policy at the Minnesota Department of Health.
AUGUST 2017 MINNESOTA PHYSICIAN
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The Future of Health Care initiative from page 33 is willing to donate their kidney to a friend or relative but it turns out to be incompatible, a database registry can ﬁnd a donor-recipient pair match that can exchange donors. This type of “paired-organ donation” approach is already being used in 20 percent of Mayo’s kidney transplant cases, resulting in better clinical outcomes and lower costs for Blue Cross members. We are also starting to guide members in need of speciﬁc orthopedic procedures and those who have low back pain to high-value providers. We recently launched a new consumer-centric diabetes solution, designed in partnership with the American Diabetes Association, featuring digital tools, peer support, care coordination, and value-based incentive payments to providers. A new maternity management pilot, just launched, features early engagement and enhanced support for Medicaid mothers-to-be. This new pilot leverages community and provider partners, including county-based public agencies, to better support women and their babies at such an important time. Care management On care management, we are helping members with everything from health coaching and utilization management to specialty-care coordination and care transition. We have created a High Complexity Care unit—an interdisciplinary clinical team dedicated to holistic care management and collaborating with community-based providers to help our members with serious and chronic health challenges. Network and payment In the areas of network and payment, we’re continuing to strengthen
our focus on identifying and leveraging ﬂexible provider networks based on value. Building on innovations in this area, Blue Cross is aligning incentives in provider contracts to promote quality and sustainable medical cost inﬂation, leveraging patient-centered medical homes, creating bundled payments, developing value-based contracts unique to the needs of the Medicaid population, and leveraging new Accountable Care Organizations capable of delivering high-value and coordinated care to members in focused provider networks.
Conclusion Blue Cross is committed to helping our members more effectively navigate a fragmented and complex health care system. We aspire to make costs and quality more transparent, predictable, and consistent going forward. Multiple factors work against that goal, including a lack of information and transparency to inform care consumption decisions—exactly the factors that a more robust HIE and growth of value-based payments would help address. Value-based health care is about helping our members and your patients access the right care at the best value. There is much we can do together. But we also know we’ll need to continue to spur innovation across communities to build a more stable health care market for Minnesotans statewide. It’s important to have stronger efforts and greater engagement—and everyone working—to make health care more sustainable. That’s how we can help Minnesota move forward toward a stronger and better “Future of Health Care.” Garrett Black is senior vice president of health services at Blue Cross and Blue Shield of Minnesota.
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The Minnesota Adult Abuse Reporting Center from page 21 suspected maltreatment and the difference such reporting could make in the lives of vulnerable adults.
Maltreatment in nursing homes MAARC is part of our strategy to improve the lives of vulnerable adults, as well as the larger population of older adults and people with disabilities. We are also working on other fronts to improve transparency, safety, and quality in our system of long-term services and supports. The Legislature this year approved additional funding for MDH to add staff who investigate allegations of maltreatment in nursing homes. Also this year, Gov. Mark Dayton proposed an Assisted Living Report Card, which would give people another tool to make informed decisions about the care they choose in assisted living settings. While legislators did not approve the proposal this year, we are hopeful that a Minnesota Assisted Living Report Card will move closer to reality in future sessions. The proposed Assisted Living Report Card is modeled on Minnesota’s successful Nursing Home Report Card, which helps people compare nursing homes while making decisions about their options. MDH and DHS created the Nursing Home Report Card in collaboration with the University of Minnesota and introduced it in 2006. It rates facilities on eight quality measures, including state inspection results and hours of direct care. Minnesota’s Nursing Home Report Card is the nation’s most comprehensive because it measures resident quality of life and family satisfaction for the 366 nursing homes certiﬁed to participate in Minnesota’s Medical Assistance Program—nearly every nursing home statewide.
Conclusion In the case of the woman whose daughter sold her house and took her possessions, she reached out for help and was connected with Minnesota’s Ofﬁce of the Ombudsman for Long-Term Care, which worked with Adult Protection at DHS to line up the housing and support services she needed. Today, the woman’s health has improved and she is no longer considered a vulnerable adult. Her daughter did not face criminal prosecution because the mother couldn’t bring herself to press charges. Had the MAARC existed during the time of this woman’s problems, it is possible she and others might have felt better-informed and more empowered to report the ﬁrst signs of abuse before the situation became more dire. This event shows that vigilance matters when it comes to protecting vulnerable adults from harm and responding quickly to maltreatment when it occurs. Over time, the data collected by MAARC will help us focus future prevention efforts to improve both the safety and quality of life for vulnerable adults. We can all play a role in making vulnerable adults safer in Minnesota by being vigilant, knowing the signs of maltreatment, and reporting suspected maltreatment.
Emily Piper, JD, is commissioner of the Minnesota Department of Human Services, the state’s largest agency. Before joining DHS in 2015, Piper served as general counsel and deputy chief of staff to Gov. Mark Dayton and as deputy commissioner and chief of staff for the Minnesota Department of Commerce.
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Change management from page 19
possibly necessary solution: exiting a bad payer contract and losing some long-time patients.
become apparent when we are mired in management minutia or subject to the blind spots associated with our corporate culture.
Finally, here’s the unsettling part. Not everyone is capable of taking perspective, or at least a wide enough perspective for the challenges they’re facing. Developmental psychologists have found This is much easier said than done. We tend to that adult minds can evolve well into middle age be deeply imbedded in our circumstances, which and that there are four distinct stages and lots of makes it very difﬁcult for us to see problems and transitional forms of mind in between (they can be issues that are literally lying in plain sight. To use identiﬁed through something called a subject-object another physical metaphor, it’s like a huge melanoma interview). These stages represent increasingly on the back of my neck. Everyone else can easily see Recognizing adaptive challenges sophisticated ways of taking perspective and it, but I’ll remain blissfully unaware until someone is much harder than it seems. making meaning. This capacity is independent tells me about it, it metastasizes, or I transcend of the “skill and will” to which companies pay the limits of perception with a mirror or camera. slavish attention—employees’ knowledge, ability, Psychologists Robert Kegan and Lisa Laskow Leahy experience, personality, motivation—and refers to refer to these blind spots as “immunity to change” the mental ﬁlter or lens that we look through to and offer some mental mirrors and X-rays to make make sense of the world. what is hidden obvious. A full description of their methods is beyond the scope of this article, however, here’s a brief sense for Back to Brian and the root cause of his ﬁasco. He never reached the how things things might play out. proverbial balcony, possibly because his form of mind doesn’t allow broader Let’s suppose that Brian makes it to the balcony and is able take a wider perspective. He determines that his clinic is hemorrhaging dollars on a particular third-party payer and that there’s no way to see those patients sustainably. But Brian’s blindspot, what Kegan and Lahey call his “hidden competing commitment,” is his clinic’s sense of duty to its patients. This immunity to change caused Brian to overlook a very uncomfortable but
perspective-taking and meaning-making. Said differently, he missed the adaptive challenge because he was incapable of seeing it—he was literally “in over his head.” David A. Frenz, MD, is a Minneapolis-based clinician and health care consultant. You can learn more about him and his work on LinkedIn.
Private health insurers have made
$65 billion in profits since 2010 Meanwhile, our patients face mounting deductibles and copays, skyrocketing drug costs, narrowing networks, and other barriers to needed care. And our medical profession is increasingly degraded by mindless paperwork and the games of a profit-hungry corporate bureaucracy. As doctors, we should be providing care to our patients, not haggling with insurers about the value of treatments that should have been covered in the first place.
Endorse The Physicians’ Proposal for Single Payer at pnhp.org/nhi 42
AUGUST 2017 MINNESOTA PHYSICIAN
I CAN DO ADVENTURE The approaching holiday season is about hope, magic and miracles. So too, is Diveheart. The Downers Grove-based not for profit organization provides hope, magic, and even miracles, to individuals with disabilities. Diveheart offers children, veterans and others with disabilities the opportunity to escape gravity through Scuba Therapy. Diveheart participants include individuals with virtually any type of disability including Down syndrome, autism, cerebral palsy, paraplegia, blindness, deafness, spinal cord injuries, traumatic brain injury, post-traumatic stress disorder and more.
HOPE The Diveheart vision is to unleash the unrealized human potential that often exists in individuals with disabilities. The confidence, independence and self-esteem realized by Diveheart participants is tremendous. Diveheart helps individuals focus on what they can do, rather than what they can’t do. MAGIC Diveheart Scuba Therapy helps participants focus on their abilities, rather than their disabilities. This helps them to take on challenges that they may never have taken on before. Furthermore the forgiving, weightless environment of underwater offers buoyancy and balance to individuals who might struggle on land. They’re often able to move in ways that are impossible before joining a Diveheart program. Zero gravity is the great equalizer. MIRACLES Diveheart participants have experienced improved range of motion, ability to focus, pain relief and more. The aspect of pressure while diving provides benefits for people with autism and chronic pain due to spinal cord injuries. Some tell us that after diving, they’re pain free for up to three weeks, often for the first time since their injury. Every one is able to help perpetuate hope, magic and miracles during the holiday season. Your donation helps to make it possible for individuals with disabilities to experience Scuba Therapy, and the resulting benefits so that they might “Imagine the Possibilities” in their lives. Please visit www.diveheart.orH EPOBUF to learn more about how you can help promote the hope, magic and miracles of Diveheart. Diveheart donations are also accepted at 900 Ogden Ave #274 Downers Grove, Illinois 60515. Jim Elliott Founder & President Diveheart
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www.coverys.com NOVEMBER 2015 MINNESOTA PHYSICIAN