Vo l u m e X X X , N o . 8 N o v e m b e r 2 016
Health is community Investing in what really creates health By Edward Ehlinger, MD, MSPH
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n his 1994 essay “Health is Membership,” Wendell Berry wrote “…the community in the fullest sense…is the smallest unit of health…to speak of the health of an isolated individual is a contradiction in terms.” Nestled within his statement is a bold challenge to Minnesota’s dominant narrative about what creates health. The Kentucky poet/farmer discovered, long before public health researchers did with the aid of Big Data and well-funded research, that health is mostly about living conditions and relationships. Individual habits and choices matter, but our health is largely determined by our community and our social circumstances.
Political divisiveness in health care Learning to work together By Ed Weisbart, MD
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ou wouldn’t know it by looking at the health care debate in America today, but one of our nation’s foundational pillars used to be political collaboration. Although the 2009 passage of the Affordable Care Act was intensely partisan, we have a proud, centuries-old legacy of collaboratively solving our problems despite our differences, and many of our past
solutions were made stronger because of our differences. I have had the honor of testifying on a variety of topics in a number of state legislatures across the nation. My experiences make me wonder how our noble national history led to political statements such as these that were said directly to me: Political divisiveness in health care to page 16
Despite Berry’s insight and the recent data that support it, this perspective is still not yet widely accepted or honored. The World Bank reports that the United States devotes more of its total gross domestic product (GDP) to health care expenditures than any other major developed nation. The U.S. Central Intelligence Agency’s World Factbook shows us how little we get in return—56 countries do better than us in infant mortality, and 41 other countries have longer life expectancy. Health is community to page 18
Rapid Response | Critical Care Life Link III is a great Midwest model of nine hospital systems cooperatively delivering the goals of the Triple Aim. These hospital systems are member-owners of Life Link III:
Life Link III operates six helicopter bases that include Alexandria, Blaine, Cloquet, Hibbing, and Willmar, Minnesota, and Rice Lake Wisconsin. The company’s helicopter and airplane services provide on-scene emergency response and inter-facility transport for patients requiring critical care. Life Link III’s transportation services are accredited by CAMTS (Commission on Accreditation of Medical Transportation Services), ensuring the highest standards of quality and safety are met.
800-328-1377 www.lifelinkiii.com
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MINNESOTA PHYSICIAN NOVEMBER 2016
www.lifelinkiii.com
NOVEMBER 2016 • VOLUME XXX, NUMBER 8
COVER FEATURES Political divisiveness in health care Learning to work together By Ed Weisbart, MD
Health is community Investing in what really creates health By Edward Ehlinger, MD, MSPH
DEPARTMENTS CAPSULES 10 MEDICUS
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INTERVIEW 14 Expanding hope for patients Tom Arneson, MD, MPH
NEUROLOGY 20 Diagnosing autoimmune encephalopathies, dementias, and epilepsies The role of neural-specific autoantibodies By Andrew McKeon, MB, BCh, MD; Sean J. Pittock, MD; and Vanda A. Lennon, MD, PhD
MEDICINE AND THE LAW
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Proper notification of payer contract changes Improving and enforcing legislation By Melissa Larson, MBA, and Nancy Haas, JD
PROFESSIONAL UPDATE: CARDIOLOGY 34 ECMO for refractory cardiac arrest A Lazarus act By Demetri Yannopoulos, MD, and Jason Bartos, MD, PhD
SPECIAL FOCUS: RURAL HEALTH Morrison County Drug Task Force Battling opioid addiction in Greater Minnesota By Kurt Devine, MD, and Heather Bell, MD
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Rural medicine and value-based reimbursement How to survive and thrive By Paul Kleeberg, MD
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Health care for migrant and seasonal farm workers Caring for the underserved By Kristi Halvarson, MHA
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A shrinking rural health care workforce Addressing the challenge By Steve Gottwalt
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www.mppub.com
PUBLISHER Mike Starnes | mstarnes@mppub.com EDITOR Lisa McGowan | lmcgowan@mppub.com ASSOCIATE EDITOR Richard Ericson | rericson@mppub.com ADVERTISING DIRECTOR Dale Decker | ddecker@mppub.com ART DIRECTOR Sunshine Sevigny | sunny@mppub.com OFFICE ADMINISTRATOR Amanda Marlow | amarlow@mppub.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@ mppub.com. 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.
NOVEMBER 2016 MINNESOTA PHYSICIAN
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MINNESOTA PHYSICIAN NOVEMBER 2016
It clicked when my doctor and I discussed Trulicity ÂŽ1,2
Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy that offers unbeaten A1C reduction* in 6 head-to-head trials, once-weekly dosing, and the Trulicity pen.1,3 If you have patients who struggle with the idea of adding an injectable, consider Trulicity as an option for the next step in their care.1,4 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction. *In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3
For more information on 6 head-to-head trials, see the following page.
Trulicity is a GLP-1 RA that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.
Select Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.
Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on inside spread and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.
Learn about unbeaten A1C reduction at Trulicity.com
NOVEMBER 2016 MINNESOTA PHYSICIAN
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Mean A1C change from ba
-0.6
-0.6
-0.8 -1.0 -1.2
-0.8
-1.1 * Unbeaten A1C reduction across 6 head-to-head trials -1.4
-1.6
Lantus® (100 mg) (n=262; Baseline A1C: 8.1%)
Trulicity® (0.75 mg) (n=272; Baseline A1C: 8.1%)
Trulicity® (1.5 mg) (n=273; Baseline A1C:1,3 8.2%)
Data represent least-squares mean ± standard error.
*In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction.
A1C reduction from baseline
MeanA1C A1Cchange change from from baseline Mean baseline(%) (%)
0.0
Add-on to metformin (26 weeks)
Add-on to metformin (52 weeks)
Add-on to metformin and Actos® (26 weeks)
Add-on to metformin and Amaryl® (52 weeks)
Compared to Victoza®3
Compared to Januvia®1,5,6
Compared to Byetta®1,7
Compared to Lantus®1,8-10
-0.2 -0.4
-0.39
-0.6
-0.46
-0.63
-0.8 -1.0
-0.87
-1.2
-0.99
-1.10
-1.4
-1.51
-1.8 Victoza (1.8 mg) (n=300; Baseline A1C: 8.1%)
Januvia (100 mg) (n=273; Baseline A1C: 8.0%)
Placebo (n=141; Baseline A1C: 8.1%)
Lantus (n=262; Baseline A1C: 8.1%)
Trulicity® (1.5 mg) (n=299; Baseline A1C: 8.1%)
Trulicity® (0.75 mg) (n=281; Baseline A1C: 8.2%)
Byetta (10 mcg BID) (n=276; Baseline A1C: 8.1%)
Trulicity (0.75 mg) (n=272; Baseline A1C: 8.1%)
Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)
Trulicity (0.75 mg) (n=280; Baseline A1C: 8.1%)
Trulicity (1.5 mg) (n=273; Baseline A1C: 8.2%)
Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)
Data represent least-squares mean ± standard error.
•
26-week, randomized, open-label comparator phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day
•
104-week, randomized, placebocontrolled, double-blind phase 3 study of adult patients with type 2 diabetes treated with metformin ≥1500 mg/day
•
Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline at 26 weeks (-1.42% vs -1.36%, respectively; difference of -0.06%; 95% CI [-0.19, 0.07]; 2-sided alpha level of 0.05 for noninferiority margin 0.4%; mixed model repeated measures analysis)
•
Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Januvia on A1C change from baseline at 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; 95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.25% margin; analysis of covariance using last observation carried forward [LOCF]); primary objective met
•
-1.08
-1.30
-1.36 -1.42
-1.6
-0.76
Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met
•
Key secondary objectives of superiority of both dulaglutide doses vs Januvia were met
Superiority was only demonstrated in the studies versus Byetta and Januvia.
Additional study results Although this was a monotherapy study, Trulicity is not recommended as a first-line therapy. In a 52-week randomized, double-blind phase 3 study, adult patients with type 2 diabetes were treated with monotherapy. Baseline A1C=7.6% for each of metformin (n=268), Trulicity 0.75 mg (n=270), and Trulicity 1.5 mg (n=269). At the 26-week primary endpoint, mean A1C reductions were metformin: 0.6%; Trulicity 0.75 mg: 0.7%; Trulicity 1.5 mg: 0.8%. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs metformin on A1C change from baseline at 26 weeks (-0.8% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met.1,11
78-week, randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Amaryl (≥4 mg/day)
•
52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos (up to 45 mg/day)
•
•
Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided alpha level of 0.025; analysis of covariance using LOCF); primary objective met
• Starting dose of Lantus was 10 units daily.
Key secondary objectives of superiority of both dulaglutide doses vs Byetta were met
•
•
Lantus titration was based on self-measured fasting plasma glucose utilizing an algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint. Mean daily dose of insulin glargine was 29 units at the primary endpoint Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 52 weeks (-1.1% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met
In a 52-week randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients, Trulicity was studied in combination with Humalog® with or without metformin ≥1500 mg/day. Humalog was titrated based on preprandial and bedtime glucose, and Lantus was titrated based on fasting glucose; 36% of patients randomized to glargine were titrated to the fasting glucose goal at the 26-week time point. Baseline A1C=8.5% for Lantus (n=296), baseline A1C=8.4% for Trulicity 0.75 mg (n=293), and baseline A1C=8.5% for Trulicity 1.5 mg (n=295). At the 26-week primary endpoint, mean A1C reductions were Lantus: 1.4%; Trulicity 0.75 mg: 1.6%; Trulicity 1.5 mg: 1.6%. Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 26 weeks (-1.6% vs -1.4%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met.1,12,13
Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on the following page and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.
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MINNESOTA PHYSICIAN NOVEMBER 2016
Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS
In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.
diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%). Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree. Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential benefit outweighs potential risk to fetus. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.
Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated. Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. Hypersensitivity Reactions: Systemic reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.
Please see Brief Summary of Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages. Please see Instructions for Use included with the pen. DG HCP ISI 20APR2015 Trulicity® and Humalog® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Actos® is a registered trademark of Takeda Pharmaceutical Company Limited. Byetta® is a registered trademark of the AstraZeneca group of companies. Amaryl® and Lantus® are registered trademarks of Sanofi-Aventis. Januvia® is a registered trademark of Merck & Co., Inc. Victoza® is a registered trademark of Novo Nordisk A/S. Other product/company names mentioned herein are the trademarks of their respective owners. References 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. 2. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014. 3. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384:1349-1357. 4. Polonsky WH, Hajos TR, Dain MP, Snoek FJ. Are patients with type 2 diabetes reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population. Curr Med Res Opin. 2011;27(6):1169-74. doi: 10.1185/03007995.2011.573623. Epub Apr 6, 2011. 5. Data on file, Lilly USA, LLC. TRU20150203A. 6. Data on file, Lilly USA, LLC. TRU20150203B. 7. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) [published correction appears in Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37:2159-2167. 8. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2) [published online ahead of print June 18, 2015]. Diabetes Care. doi:10.2337/dc14-1625. 9. Data on file, Lilly USA, LLC. TRU20140912A. 10. Data on file, Lilly USA, LLC. TRU20150313A. 11. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37:2168-2176. 12. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385:2057-2066. 13. Data on file, Lilly USA, LLC. TRU20150313B.
The most common adverse reactions reported in ≥5% of Trulicitytreated patients in placebo-controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%),
PP-DG-US-0393
01/2016
©Lilly USA, LLC 2016. All rights reserved.
NOVEMBER 2016 MINNESOTA PHYSICIAN
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TrulicityTM (dulaglutide) Brief Summary: Consult the package insert for complete prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS • In male and female rats, dulaglutide causes a dose-related and treatmentduration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. • Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.
insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting. Hypersensitivity Reactions: Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. If a hypersensitivity reaction occurs, the patient should discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal failure, use caution when initiating or escalating doses of Trulicity in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. ADVERSE REACTIONS
INDICATIONS AND USAGE Trulicity™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Risk of Thyroid C-cell Tumors: In male and female rats, dulaglutide causes a doserelated and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether Trulicity will cause thyroid C-cell tumors, including MTC, in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. One case of MTC was reported in a patient treated with Trulicity. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of Trulicity and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. Pancreatitis: In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis-related adverse reactions were reported in patients exposed to Trulicity versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analysis of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to Trulicity (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years). After initiation of Trulicity, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue Trulicity. If pancreatitis is confirmed, Trulicity should not be restarted. Trulicity has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: The risk of hypoglycemia is increased when Trulicity is used in combination with
Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Pool of Placebo-controlled Trials: These data reflect exposure of 1670 patients to Trulicity and a mean duration of exposure to Trulicity of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Trulicity-Treated Patients: Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5 mg (N=834) (listed as placebo, 0.75 mg, 1.5 mg): nausea (5.3%, 12.4%, 21.1%), diarrheaa (6.7%, 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%, 4.2%, 5.6%). (a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.) Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.75 mg and 1.5 mg of Trulicity as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively. In addition to the adverse reactions ≥5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%; 3.9%; 3.7%), flatulence (1.4%; 1.4%; 3.4%), abdominal distension (0.7%; 2.9%; 2.3%), gastroesophageal reflux disease (0.5%; 1.7%; 2.0%), and eructation (0.2%; 0.6%; 1.6%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of Trulicity as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3342 patients with type 2 diabetes were treated with Trulicity for a mean duration 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as ≥5% above. Other Adverse Reactions: Hypoglycemia: Incidence (%) of Documented Symptomatic (≤70 mg/dL Glucose Threshold) and Severe Hypoglycemia in Placebo-Controlled Trials: Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), Trulicity 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5 mg: 5.0%; Severe: all 0. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. Documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg
TrulicityTM (dulaglutide)
TrulicityTM (dulaglutide)
Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease. The concurrent use of Trulicity and basal insulin has not been studied. CONTRAINDICATIONS Do not use in patients with a personal or family history of MTC or in patients with MEN 2. Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components. WARNINGS AND PRECAUTIONS
Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75
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MINNESOTA PHYSICIAN NOVEMBER 2016
DG HCP BS 20APR2015
DG HCP BS 20APR2015
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and 1.5 mg, respectively, was co-administered with prandial insulin. Severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg, and 1.5 mg, respectively, was co-administered with prandial insulin. Heart Rate Increase and Tachycardia Related Adverse Reactions: Trulicity 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm). The long-term clinical effects of the increase in HR have not been established. Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to Trulicity. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4%, and 1.6% of patients treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3%, and 2.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Immunogenicity : Across four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) Trulicitytreated patients developed anti-drug antibodies (ADAs) to the active ingredient in Trulicity (ie, dulaglutide). Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies against native GLP-1. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products. Hypersensitivity : Systemic hypersensitivity adverse reactions sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and Phase 3 studies. Injection-site Reactions: In the placebo-controlled studies, injection-site reactions (eg, injection-site rash, erythema) were reported in 0.5% of Trulicity-treated patients and in 0.0% of placebo-treated patients. PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) Block: A mean increase from baseline in PR interval of 2-3 milliseconds was observed in Trulicity-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with Trulicity than placebo (0.9%, 1.7%, and 2.3% for placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5%, and 3.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Amylase and Lipase Increase: Patients exposed to Trulicity had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebotreated patients had mean increases of up to 3%. DRUG INTERACTIONS Trulicity slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to any clinically relevant degree. USE IN SPECIFIC POPULATIONS Pregnancy - Pregnancy Category C: There are no adequate and well-controlled studies of Trulicity in pregnant women. The risk of birth defects, loss, or other adverse outcomes is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes to maintain good metabolic control before conception and throughout pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats and rabbits, dulaglutide administered during the major period of organogenesis produced fetal growth reductions and/or skeletal anomalies and ossification deficits in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for clinical adverse reactions from Trulicity in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years. Geriatric Use: In the pool of placebo- and active-controlled trials, 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. Renal Impairment: In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicitytreated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2). TrulicityTM (dulaglutide)
Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75
DG HCP BS 20APR2015
No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed. There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored. Gastroparesis: Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with pre-existing gastroparesis. OVERDOSAGE Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (eg, nausea, vomiting) and nonsevere hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms. PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide • Inform patients that Trulicity causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician. • Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Trulicity promptly, and to contact their physician, if persistent severe abdominal pain occurs. • The risk of hypoglycemia may be increased when Trulicity is used in combination with a medicine that can cause hypoglycemia, such as a sulfonylurea or insulin. Review and reinforce instructions for hypoglycemia management when initiating Trulicity therapy, particularly when concomitantly administered with a sulfonylurea or insulin. • Patients treated with Trulicity should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with Trulicity of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs. • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, patients must stop taking Trulicity and seek medical advice promptly. • Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant. • Prior to initiation of Trulicity, train patients on proper injection technique to ensure a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inform patients of the potential risks and benefits of Trulicity and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and advise patients to seek medical advice promptly. • Each weekly dose of Trulicity can be administered at any time of day, with or without food. The day of once-weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before. If a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, it should be administered as soon as possible. Thereafter, patients can resume their usual once-weekly dosing schedule. If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, the patient should not administer the missed dose and instead resume Trulicity with the next regularly scheduled dose. • Advise patients treated with Trulicity of the potential risk of gastrointestinal side effects. • Instruct patients to read the Medication Guide and the Instructions for Use before starting Trulicity therapy and review them each time the prescription is refilled. • Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. • Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range. HbA1c is especially useful for evaluating long-term glycemic control.
Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2014, 2015, Eli Lilly and Company. All rights reserved. Additional information can be found at www.trulicity.com DG HCP BS 20APR2015 TrulicityTM (dulaglutide)
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CAPSULES
HealthPartners Joins Campaign to End Rising Drug Costs HealthPartners has joined the Campaign for Sustainable Rx Pricing, a coalition of organizations working to curb rising prescription drug prices. It is a project of the National Coalition on Health Care consisting of members such as hospitals, physicians, nurses, consumers, health plans, pharmacists, and employers. The campaign is asking drug companies for transparency (reporting how much it costs to make a medication); competition (making generic drugs more available); and value (showing that new drugs are better than medications already available). “Medications help people live longer, better lives, and we want everyone to benefit from them,” said Mary Brainerd, president and CEO of HealthPartners. “But that can’t happen if people can’t afford them. And today, rising drug prices are the main cause of rising health care costs. This can’t continue. This campaign is about creating a prescription drug
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market so that it benefits all stakeholders. As an organization serving millions of patients and health plan members, we are eager to strengthen our partnerships with other groups to achieve this goal.” The Alliance of Community Health Plans also joined the campaign recently; HealthPartners is an ACHP member.
Use of Short-Acting Opioids Decreased, Long-Acting Increased Pharmacy claims for short-acting opioids decreased while claims for long-acting opioids increased from 2014 to 2015, according to Prime Therapeutics. Overall, there was a slight decrease of 3.9 percent in opioid claims in that time period. The pharmacy benefit manager analyzed administrative pharmacy claims from 15 million commercially insured members from Jan. 1, 2014, through March 31, 2016. During that time, there were 20.5 million opioid claims, which included four categories— non-abuse-deterrent short-acting;
MINNESOTA PHYSICIAN NOVEMBER 2016
non-abuse-deterrent long-acting; abuse-deterrent with Food and Drug Administration (FDA) validation; and abuse-deterrent without FDA validation. Results of the analysis show that short-acting opioids decreased 4.5 percent; long-acting opioids without abuse-deterrent properties increased 2 percent; long-acting abuse-deterrent opioids with FDA validation increased 3.2 percent; and long acting abuse-deterrent opioids without FDA validation increased 26 percent. In addition, long-acting opioids accounted for 8 percent of all claims volume and 48.6 percent of total cost while short-acting opioids represented 92 percent of claims and 51.4 percent of total cost. “With new laws requiring coverage of abuse-deterrent opioids, future utilization and cost trends in this category could increase,” said Cathy Starner, PharmD, principal health outcomes researcher at Prime Therapeutics. “It is important for insurers to understand both legislation and current utilization patterns to help forecast trends in this drug category.”
St. Francis Opens New Entrance and Lobby St. Francis Regional Medical Center, owned by Allina Health, Park Nicollet, and Essentia Health, has completed a $7 million, 15,500-square-foot renovation that expanded its entrance and increased its footprint by more than a quarter acre. The expanded entrance area includes a new pharmacy operated by Allina Health, an eye care department operated by Park Nicollet (relocated from the current locations inside the clinic), a health care retail store operated by Park Nicollet, and a coffee shop. The medical center chose to expand in order to make it more convenient for patients to fill prescriptions; create a distinguishable, easier to navigate front entrance; and make space for Park Nicollet Clinic to expand with the relocation of its retail stores. “It is estimated that more than 30 percent of prescriptions never get filled if a patient leaves a hospital without them,” said Mike McMahan, president of St. Francis. “Our new onsite outpatient pharmacy will help ensure that our
patients leave St. Francis with a healthier care experience.” St. Francis is in the process of upgrading patient rooms in the southern wing after completing operating room upgrades and has plans to renovate the emergency and ambulance areas.
St. Cloud Health Care System Merger Approved CentraCare Health and St. Cloud Medical Group are proceeding with a full integration of their operations, completing discussions that began in November 2015. The transaction has been reviewed by the Federal Trade Commission and was approved to move forward immediately on Oct. 6. The integration took effect on Oct. 7 and will be completed in two phases over the next two years. Current patients of St. Cloud Medical Group—which Diana White, a St. Cloud Medical Group administrator, estimates to be between 75,000 and 95,000—will be able to continue receiving care at St. Cloud Medical Group locations. All five of the health care system’s locations will remain open and retain their names—Clearwater Medical Clinic, Cold Spring Medical Clinic, Midwest Occupational Medicine-South, St. Cloud Medical Group-Northwest, and St. Cloud Medical Group-South.
DHS Awards Grants to Improve Residential Mental Health Services The Minnesota Department of Health (DHS) has awarded $2.9 million in grants to 41 community-based mental health programs to help sustain and improve intensive residential mental health services across the state. “These funds are sorely needed by these critical programs and the Minnesotans they serve,” said Emily Piper, DHS commissioner. Two residential treatment mental health programs have closed in recent years and a 2015 DHS legislative report found that many existing ones are vulnerable to closure, face barriers to improving services, and are challenged to meet the changing needs of individuals receiving services, according to DHS. Recommendations in the report included providing funding to cover facility costs to prevent closures
and for health, safety, and therapeutic building improvements. The grant funds will be used to improve care, offer new services, and fill the gap in services that are not presently funded. Of the $2.9 million in grants, $500,000 was awarded to cover start-up costs to expand adult residential crisis services across the state, including a new program in Itasca County and two new shortterm residential treatment programs in Sherburne and Hennepin counties. In addition, $1.3 million was awarded to improve health and quality of care, allowing 15 agencies to add staff and make improvements for existing programs. These include health and safety improvements, which are not reimbursed by federal Medicaid services. These funds were awarded to agencies in Brown, Clay, Douglas, Hennepin, Mower, Olmsted, Ramsey, St. Louis, Stearns, and Washington counties. The remaining grant funds, totaling $1.1 million, went to 36 agencies for uncompensated room and board costs to improve sustainability. DHS expects these grants will help address problems agencies face in maintaining the level of care needed for the people they serve, since federal funds pay for treatment services but don’t cover room and board expenses.
Essentia Health to Build Clinic in Pine River Essentia Health will begin construction on a new clinic in Pine River beginning next summer. The new clinic, which will house expanded primary care and specialty services, will be located on seven acres of land along Barclay Ave. to the west of Hwy. 371. “The community needs more access to specialists and rather than asking patients to drive to Brainerd, which can be both a time and cost barrier to getting care, we put a priority on expanding our space to bring the specialists here to Pine River,” said Bill Palmer, Essentia Health clinic administrator. “We currently have cardiology, general surgery, psychiatry, and urology specialists visiting the clinic a few times a month. However, there are more needs and the larger clinic will allow for more specialists and an expansion of the family medicine team.” The current clinic was built in 1975. The practice combined with St. Joseph’s Medical Center in 1995. Capsules to page 12 NOVEMBER 2016 MINNESOTA PHYSICIAN
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Mayo Clinic, MIT to Research Drug Delivery to Brain Tumors The National Cancer Institute (NCI) has awarded Mayo Clinic and the Massachusetts Institute of Technology (MIT) a five-year, $9.7 million grant. The funds will go toward supporting an NCI-affiliated Physical Sciences-Oncology Center. Researchers hope to learn more about the physical parameters that limit drug delivery into brain tumors and use that information to build models that will help physicians better predict how the body will distribute a drug to brain tumors and therefore select the best drug to treat each individual patient based on their unique tumor. “The most common types of malignant brain tumors—brain metastases originating from cancers outside of the brain, and glioblastoma—have regions that are protected from most drugs,” said Jann Sarkaria, MD, researcher in Mayo Clinic’s translational neuro-oncology laboratory and co-principal investigator of the project. “Low-level drug exposure
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in these regions can promote drug resistance and that may be why there have been no new effective drug treatments for brain tumors in more than a decade.” Ten institutions were selected to participate in the NCI Physical Sciences-Oncology Network, which supports innovative ideas that blend perspectives and approaches from the fields of physical science, engineering, and cancer research with the goal of improving the understanding of cancer biology and oncology.
Summit Orthopedics to Expand Summit Orthopedics will assume full operations of an orthopedic care facility in Faribault and intends to collaborate with Northfield Hospital and Clinics on medical services in Northfield, Lakeville, and Farmington. The clinic locations are currently staffed by Mankato-based Orthopedic and Fracture Clinic and will become Summit Orthopedics clinical care sites in January 2017. Five of the current surgeons from Orthopedic and Fracture Clinic and the entire medical and support staff from
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the Faribault clinic will become Summit employees. An expansion is also planned in Eagan, with a new facility that will open spring 2017. The new location will provide an outpatient ambulatory surgery center and extended access to more advanced surgical procedures.
Total Cost of Care Increased Nearly 6% The total cost of medical care for commercially insured patients in Minnesota increased 5.6 percent, from $449 per month in 2014 to $474 per month in 2015, according to a report from Minnesota Community Measurement (MNCM). Previously, total cost of care increased 3.2 percent between 2013 and 2014. “The increase is more than the previous year and greater than the average increase in people’s income in Minnesota,” said Jim Chase, president of MNCM. Total cost of care results varied widely among medical groups in 2015, ranging from $365 to $914 per patient per month. The average total cost of care in 2015 for adult patients age 18 to 64 was $558 per month and for pediatric patients
age 1 to 17 it was $238 per month. The comparisons also track the change in total cost of care for patients by the types of services they received. Pharmacy costs increased the most, by more than 9 percent between 2014 and 2015. In addition to total cost of care results, MNCM tracks the costs of 90 common medical procedures at medical groups across the state. The data shows the average amount paid to each medical group by commercial health plans for the procedures. Four new ones were included this year—cardiac stress test; colorectal cancer screening, fecal blood test; lower extremity CT without contrast; and vasectomy. Results show a wide range of costs—a glucose test can cost from $6 to $51; a knee X-ray can cost from $20 to $219; and a 15-minute office visit can cost from $75 to $210, depending where patients seek care. This is MNCM’s third release of overall total cost of care information. Results are based on 2015 health insurance claims of more than 1.5 million commercially insured patients enrolled with four Minnesota health plans—Blue Cross and Blue Shield of Minnesota, HealthPartners, Medica, and PreferredOne.
MEDICUS JANE PEDERSON, MD, MS, chief medical quality
officer at Stratis Health, has been selected to serve on a Centers for Medicare & Medicaid Services (CMS) Technical Expert Panel on quality measures to help achieve the goals of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act). Pederson has experience as a geriatrician Jane Pederson, in post-acute care settings, 20 years of CMS MD, MS Quality Improvement Organization experience, training in health services research, and experience teaching graduate-level health care quality and measurement. She earned her master of science degree in health services research policy and her doctor of medicine degree at the University of Minnesota. She also currently serves as an adjunct assistant professor in the division of health and policy management at the University of Minnesota School of Public Health. TROY DUININCK, MD, chief of surgery at Essentia Health–St. Joseph’s Medical Center and Clinics, was chosen as a 2016 Value Ambassador by the health care system for living the value of quality for excellence in individualized care to patients and outstanding relationships with staff. He was nominated for being constantly focused on safety, especially in the operating room, as well Troy Duininck, as his review of evidence-based studies and MD articles that keeps him knowledgeable about the latest clinical recommendations. Duininck earned his medical degree at the University of Minnesota Medical School and completed a residency and fellowship at Mayo Graduate School of Medicine. AMY CATALFAMO, MD, has joined the Noran
Amy Catalfamo, MD
Neurological Clinic as a pediatric neurologist. Catalfamo earned her medical degree from State University of New York Downstate Medical Center College of Medicine, followed by her pediatric and pediatric neurology residencies at Strong Memorial Hospital in Rochester, NY. Her clinical interests include general pediatric neurology, epilepsy, and developmental delay. She sees patients at the Minneapolis and Lake Elmo clinics.
BENJAMIN STRONG, MD, chief medical officer of vRad (an Eden Prairie-based teleradiology services and telemedicine company), has been chosen as a member of the American College of Radiology’s (ACR) Committee on Emergency Radiology (General, Small & Rural Practice). He will work with 15 other experts to address issues around emergency radiology, from Benjamin Strong, rural to academic tertiary centers, and help MD inform ACR policy about emergency radiology coverage, quality/safety issues, and practice parameters. Strong earned his medical degree from the University of Arizona College of Medicine, completed his residency in internal medicine at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and completed both a radiology residency and a fellowship in musculoskeletal MRI at the University of Arizona Health Sciences Center. NOVEMBER 2016 MINNESOTA PHYSICIAN
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INTERVIEW
Expanding hope for patients
TOM ARNESON, MD, MPH Research Manager, Office of Medical Cannabis, Minnesota Dept. of Health Dr. Arneson provides a clinical and research perspective to implementation of the state’s medical cannabis program and oversees research on the program’s impact. He received his Bachelor of Arts degree from Harvard, his Doctor of Medicine degree from Mayo, and his Masters of Public Health degree from the University of Minnesota. He is board-certified in public health and general preventive medicine.
The Minnesota Legislature passed a law in 2014 legalizing the manufacture, sale, and use of medical cannabis. Minnesota has a vertically integrated program that only permits two registered manufacturers to grow, cultivate, and sell the medicinal products. To obtain medical cannabis, patients and health care providers are required to register with the Minnesota Medical Cannabis program patient registry. Physicians can choose to participate and “certify” patients who have been diagnosed with at least one of the qualifying medical conditions required for registration in the program. The registration process is confidential and simple, and the Board of Medical Practice protects physicians from any civil or disciplinary penalties.
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What does your work as the research manager of the Office of Medical Cannabis (OMC) entail? A distinctive part of Minnesota’s program is tracking what happens with enrollees, including what they purchase and what they and their certifying provider report as benefits and harms. I helped design how information is collected during program participation and my staff and I are now organizing and analyzing data from the first year of the program. I also summarize existing research literature and spend significant time doing presentations and communicating with clinicians.
But there is also positive feedback from physicians— in particular about patient benefits. This comes both through informal conversations and through survey comments for each patient they certify. The hope that medical cannabis products would facilitate patients reducing dose or discontinuing opioid and benzodiazepine drugs is now being fulfilled for numerous patients. There will be more specific data on this question in 2017 when survey results for patients certified for intractable pain start being tabulated.
As of September 15, 2016 there were 564 physicians registered in the program, along with 86 advanced practice registered nurses, and 36 physician assistants. What are the goals of the medical cannabis program? The number of registered physicians has been growing The objectives of the law that established the steadily, and in fact has picked up over the past couple program were to allow therapeutic use of medical of months. cannabis and to prevent its misuse or diversion. The allowed cannabis products are more medical in Many physicians feel that there is no research to nature than in most other states’ programs, in that support the efficacy of medical cannabis. How do they are ingested as capsules, liquids, or vaporized you respond to this claim? oils. Required third-party laboratory testing ensures The nature and amount of research varies greatly product safety, content, and consistency. Minnesota’s by condition. There is a report on the OMC web program is more restrictive than programs in many site that summarizes clinical trials for each of the other states—a point of criticism for many—as it does qualifying conditions in the Minnesota program. For not allow smoking or edible forms. Currently, there are some qualifying conditions the clinical trial evidence no reports from law enforcement of diversion and no is almost non-existent. For others, it is strong enough reports of serious adverse events. that a cannabis extraction drug very similar to drugs being produced in the Minnesota program has been Please share some of the responses you have received approved by the equivalent of the FDA in Canada, Israel, the United Kingdom, and multiple other from physicians, both positive and negative. As might be expected, there is much skepticism European countries. As has been covered extensively and some passionate criticism. But there are many— in the media, clinical research on cannabis in the U.S. including some of the skeptical and critical—who has been made very difficult by onerous federal rules are open to the possibility that the program could resulting from cannabis being a Schedule 1 drug. offer benefit to patients of theirs who have not been Much of the clinical research has been conducted doing well with their current therapies. A frequent outside of the U.S. response is that more research is needed before cannabis-based medications are used—in particular, What can you tell us about the endocannabinoid large clinical trials of long duration. Closely related, system (ECS)? many physicians express the belief that cannabisThe human ECS is a set of ligand molecules, based medications should follow the traditional route mechanisms that modulate their creation and of approval by the FDA rather than state government destruction, receptors and other cellular structures programs. Physician control is also an issue. Though they activate, effects of activation on cell processes, participating clinicians can see via their web account and resulting consequences for the body’s physiology. the products their patients buy and symptom change The ECS is often referred to as a homeostatic system, and side effect info, physicians do not prescribe the helping the body maintain constancy of internal cannabis products. They can advise the patient what environment despite the body’s response to external they think they should use, but the decision is made by environmental challenges. Various types of cannabis the patient in consultation with a pharmacist working receptors are found throughout the body, with one type at the cannabis distribution centers who is employed especially dense in certain parts of the brain and central by the cannabis product manufacturer. Other nervous system and another densely located on certain responses include fear of getting in trouble with the cells of the immune system. The ECS has been shown federal government, lack of knowledge about cannabis to interact with several of the body’s other systems. and the endocannabinoid system, the added time and stress of discussing cannabis with patients, and Why are so few physicians familiar with the ECS? potential for abuse and addiction. And some dismiss The ECS has not been part of their training. It was the program as a front for recreational legalization of only about 20 years ago that the first awareness of its marijuana. existence started to develop, and research about it has
MINNESOTA PHYSICIAN NOVEMBER 2016
accelerated since then. Colleges of medicine, nursing, and pharmacy are just starting to incorporate instruction about the ECS in their curricula and science-based online CME courses have been developed only in the past few years. However, there are thousands of published research articles on the ECS.
However, risk of federal prosecution for a physician certifying a patient in the Minnesota program, though not zero, is probably pretty close. The physician’s formal role is to certify that a patient has a qualifying condition under the program. The risk is if certification would ever be prosecuted as aiding and abetting access to an illegal drug. Given the momentum of medical cannabis programs throughout How do you respond to physicians who the country, I anticipate change in federal feel that medical cannabis is a gateway to regulations to accommodate state programs addiction and more powerful drugs? There is some epidemiologic and animal- rather than action that challenges the existence model data suggesting that use of marijuana in of these programs. adolescence could influence multiple addictive behaviors in adulthood. But there is another potential explanation for the observed pattern of adolescents using marijuana (or alcohol or There is ... positive tobacco) first, and then additional drugs later. It feedback from physicians could be that people more susceptible to drugtaking behavior are more likely to start with —in particular about marijuana (or alcohol or tobacco) because of patient benefits. its accessibility and that the subsequent social interactions with other drug users increases their likelihood of trying additional drugs. Both explanations could have some truth to them. Please share some success stories that you How do you respond to physicians who have seen in the brief time that your office are concerned about participation in the has been open. program because medical cannabis remains Both patients and their certifying health care practitioners describe a high level of illegal under federal law? Participation in the program is voluntary so benefit for many. Survey findings for patients physicians can wait on registering themselves. enrolled during the first three months are in a
report now on the OMC web site. Much more detailed descriptions of the patients and their experiences will become available over the next six months. The impact has been dramatic— even life changing for some. I have heard some of these stories directly from patients and some have been featured in the press. Though these are sometimes derived as “anecdotes,” it is important to remember that for the patient and their family, the life improvement can have profound significance.
What do you see as the future for medical cannabis? Immense resources are going into research to deepen the understanding of the ECS and create molecules that manipulate components of the ECS. I anticipate a family of ECS modulators will be in routine clinical use within the next 10 to 20 years. Shorter term, a small number of plant-based cannabinoid products and synthetic cannabidiol are likely to go through the FDA review process. In parallel, a wider range of cannabis extraction products will be developed in state programs such as Minnesota’s. There are strong advocates of medical use of whole plant products (smoked and edibles, for example). The degree to which whole plant flourishes for medical use will depend on systems to ensure standardized, safe products, and whether states legalize recreational cannabis use.
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Political divisiveness in health care from cover
• From a cattle rancher serving as a state representative: “As a former embryo, I have expertise about women’s reproductive choices.” This was the basis for his ignoring medical evidence about conception, embryology, and the guidance of the American College of Obstetrics and Gynecology. It’s difficult to build an evidence-based strategy with a legislator who believes his personal history as an embryo gives him as much information about reproductive issues as being board-certified in ob-gyn. • From an attorney serving as a state representative: “I oppose raising the tax on cigarettes because you can’t assure me the money won’t be used to clone humans.” It’s hard to determine the best strategy to prevent adolescent tobacco addiction without also having
to weigh the risks and merits of stem cell research. • From a psychiatrist serving as a state senator: “I think about all 12 antidepressants, and I think about my patient, and something inside me moves and tells me which one to prescribe.” I was a bit worried about what
and economic data from expansion states (those states that have taken advantage of the ACA’s offer to expand Medicaid) has no place in a policy discussion when the decision has already been made based on political goals. At least this senator was willing to be open and direct.
We Americans have solved some very difficult problems by working together.
might be moving inside of him, but held my tongue in the interest of finding common ground. • Finally, from another attorney serving as a state senator: “I acknowledge your evidence that expanding Medicaid would save many lives, but as a state senator I’m still going to block it for political reasons.” Rigorous analysis of the emerging clinical
How did we get to the point where reproducible evidence is valued as highly as uninformed conjecture, where attitude and philosophy are considered as independent truths, and politics trumps science even for professionals? And how do we get back to building public policies on evidence, reason, and collaboration? There is a body of science that can help us find our way back. The imperative is stronger, especially when it comes to health care. The Centers for Medicare & Medicaid Services (CMS) projects that by 2022, health care spending will consume 19.9 percent of our GDP. It is difficult to see how our nation can bear this burden—roughly double that of any other modern nation—and expect our businesses to remain globally competitive. As difficult as it may be to entertain solutions that would impact such a large percentage of our GDP today, the problem will only get worse the longer we fail to fully address it. These days, it seems we cannot even talk with each other, let alone co-forge constructive solutions. A history of collaboration We Americans have solved some very difficult problems by working together. In 1787, the Great Compromise innovatively created a bicameral legislature, resolving a struggle that threatened to end the Constitutional Convention.
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In 1860, President Abraham Lincoln appointed a “team of rivals” to his cabinet, embracing the competition from both his own party’s primary and the general election. Lincoln explained that he felt he had no right to deprive the country of its strongest minds simply because they sometimes disagreed with him. In 1935, the Social Security Act was passed with overwhelming majorities in both major parties. In 1965, Medicare was enacted with strong support from both parties. In 1984, bipartisan legislation transformed the pharmaceutical manufacturing industry with the Drug Price Competition and Patent Term Restoration Act, commonly referred to as the Hatch-Waxman Act. While extending brand drug patent periods, it also created a new FDA pathway for the more rapid approval of generic equivalents to those brand drugs. As a result, generic manufacturers are no longer required to reproduce the expensive clinical studies that brought the originator drug to market; Hatch-Waxman only requires the generic drug manufacturers to provide proof of bioequivalency, essentially creating the generic drug industry. From 1983 to 2016, generic drug utilization has increased from 19 percent to 90 percent of all prescriptions in the U.S. The Hatch-Waxman Act struck a balance between economically entrenched polarities: it created a far less costly generic drug manufacturing niche while providing substantially stronger market protection for new drugs. This contentious, groundbreaking, and ultimately transformative bill was co-written by a Republican from Utah and a Democrat from California. It passed by voice vote in both chambers, and reminds us where we once were and how far we’ve drifted off course. We need to return to that place of civil discourse where we were united by evidence and purpose, and not divided by party. We need
to relearn how to respect those with whom we disagree, how to find common ground, and how to collaborate in building the necessary innovative solutions for today and tomorrow. Understanding political polarization Fortunately, there is a body of research that can help us better understand each other. Jonathan Haidt, social psychologist and professor of ethical leadership at New York University’s Stern School of Business, describes what he calls “moral foundations theory” in his 2012 book, “The Righteous Mind: Why Good People Are Divided by Politics and Religion.” By analyzing 132,000 online surveys of Americans, he has determined how five moral values (fairness, caring, loyalty, authority, and sanctity) correlate with positions on the political spectrum. His results illustrate why it’s so easy for us to unintentionally disrespect each other. According to Haidt, liberals tend to endorse both fairness (reciprocal altruism, justice, rights, and autonomy) and caring (empathy, kindness, gentleness, and nurturance). Conservatives endorse these values with less enthusiasm, but additionally endorse three other values: loyalty (patriotism and self-sacrifice), authority (deference to leadership and respect for traditions), and sanctity (the notion that bodies are temples desecrated by immorality).
the elusive common ground. Common themes by universal health care advocates include phrases like “Everybody in, nobody out,” or “Health care is a right, not a privilege.” They resonate strongly with liberals because they activate a liberal’s core values of caring and fair-
the implications for their other moral values. When presented only through the liberal lenses of caring and fairness, some conservatives worry that an entitlement to health care could be corrosive to the moral imperative for individual responsibility, or that granting broader access
We need to return to that place of civil discourse where we were united by evidence and purpose, and not divided by party. ness. At the same time, these statements unwittingly distress many conservatives for whom these phrases suggest an undeserved entitlement, divorcing actions from consequences, enabling weakness, undermining individual responsibility, and exacerbating the moral hazard that leads to unhealthy personal decisions. Phrases that liberals so proudly rally around are unwittingly corrosive to a broader consensus.
to health care can undermine access for the group to which they themselves are the most loyal. Conservatives may thus see a conflict between their values of fairness/caring as opposed to loyalty/sanctity, a conflict to which liberals are often blind. Haidt’s data could guide us toward a different discussion about universal access to health
care, one that better resonates with the moral values held by many conservatives: • P revent able prematu re deaths caused by a lack of universal access to health care is a violation of the conservative moral value of sanctity. This is a moral value of lower relative priority to many liberals, who typically center discussions about health care access on fairness and caring, and infrequently as an issue of sanctity. • Enhancing your community’s health should tap the conservative moral value of loyalty. The issue becomes one of defining your community as the entire nation. • The large body of faithbased leaders advocating for universal health care aligns with the conservative moral value of authority.
Political divisiveness in health care to page 42
A less-polarizing statement for the desired goal of health care reform might be, “The best health care in the world, efficiently delivered.” This statement elicits both liberal and conservative frames, with an emphasis on the liberal value of caring, equally paired with more conservative values of loyalty, authority, and sanctity.
Liberals, thus, often see conservatives as inadequately sensitive to the demands for fairness and caring. Conservatives, on the other hand, see liberals as immorally deficient in loyalty, authority, and sanctity. It’s not difficult to see how collaboration could be undermined by a failure to respect these differences.
Analyzing progressive talking points The progressive health care community has four common talking points, each of which can inadvertently offend conservatives. Let’s walk through these, apply the lessons of Haidt’s research, and look for the common ground.
Examining the use of language The century-old movement for universal access to health care demonstrates how these moral values can help us find
The f irst core tenet of progressive policies is universal access to health care, tapping into the liberal values of fairness and caring. Conservatives don’t generally disagree with this goal, but are equally concerned about
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Health is community from cover
The problem isn’t that we’re not investing enough money on health; rather it is how we are investing that money. Unlike countries with better health outcomes, we spend relatively little on keeping people healthy and devote massive amounts to treating people after they’re sick. A flawed strategy Why do we stick with such a flawed strategy? Part of the answer lies in our country’s dominant narrative about what creates health; a narrative that emanates from the cultural ideal of the independent, rugged individual. That narrative posits that staying healthy is the responsibility of individuals, and sick people are the responsibility of the health care system. This individual-centered perspective allows little room for
community or social influences. Widespread use of this narrow frame explains the chronic underfunding of public health and social services in the United States, as well as the underresourcing of other sectors that influence health.
country negatively affecting populations of color and American Indians. Health disparities not only affect the health of people and neighborhoods on the bottom of the health and socio-economic ladder, but also limit the potential of everyone
[Minnesota has] some of the biggest health disparities in the country.
Health disparities Not only does this individual- focused approach yield a poor return on investment, it also contributes to other negative outcomes including disparities in health status between racial and ethnic groups. Minnesota ranks high on many lists of healthy states; still we have some of the biggest health disparities in the
in our society to achieve full health. We should be motivated not only by social justice but by simple self-interest in addressing these disparities. How can we possibly take on the social and economic factors (the social determinants of health) responsible for these health disparities? How can we reduce and eliminate disparities that have been plaguing communities for decades or even centuries? How can we advance health equity so that everyone has the opportunity to achieve optimal health? The role of community The answer lies in transforming the work of not only public health and health care but of all sectors of society. It will require a more inclusive communityoriented narrative about what creates health; sharing the responsibility of creating health with partners outside of the health care and public health sectors; and engaging communities to foster change in the conditions where people live and work. We can do this by embracing the Triple Aim of Health Equity (see Figure 1). Like the well-known Triple Aim of Health Care, this model highlights three major practices that are critical to the overall goal. The Triple Aim of Health Equity highlights the powerful influence of narrative, partnerships, and community.
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The Triple Aim of Health Equity includes three core practices, or “aims”: 1. Expand our understanding of what creates health. Think about the impact of living conditions and other social determinants on health outcomes and the role that policies play in shaping those living conditions. 2. Implement
a Health in All Policies approach with health equity as the goal. Such an approach understands that policies related to transportation, housing, financial security, education, public safety, and environmental protection can affect health outcomes, encouraging us to work across sectors to implement policies that will broadly affect health. 3. Strengthen the capacity of communities to create their own healthy future. Support and empower communities to create policies and systems that improve living conditions and a higher quality of life.
What can physicians do? Physicians should be partners in addressing the Triple Aim of Health Equity, because they see how the factors influencing health and disease—income, education, housing, personal behaviors—occur outside the clinic and beyond their control. I know physicians get fatigued by a constant presumption that they can eliminate all health problems. This unfair burden on doctors is yet another negative effect of the “health care as panacea” narrative. Physicians, who are leaders in their communities, are in a good position to further health equity beyond treating individual patients. Physicians can implement the core practices by starting conversations at their own health care organizations or at the other places where they have influence, such as businesses, churches, volunteer groups, or government bodies.
Physicians can enter into these spaces and ask the following questions to further the health equity conversation: • Who is at the decision/policymaking table, and who is not? • Who is being held accountable and to whom? • What are the health and equity implications of any decision? • Who is benefiting and who is left out? • What values/worldviews underlie the decision-making process? What MDH is doing The Minnesota Department of Health (MDH) has started asking these questions. This has led to new insights and new ways of operating, such as expanding our radon program beyond homeowners to renters and doing more to inform African Americans about their sickle cell disease risks. This intentional process has led to more than 100 examples of program-level milestones or efforts underway at MDH. Physicians and public health are crucial to creating healthy communities, but the Triple Aim
and economic development to partner with us in this work. In “The Art of the Commonplace: The Agrarian Essays,” Wendell Berry writes: “A proper community is a commonwealth: a place, a resource, an economy. It answers the needs, practical as well as social and spiritual, of its members—among them the need to need one another. The answer to the present alignment of political power with wealth is the restoration of the identity of community and economy.” This underscores the fact that to build healthy communities for generations to come, the community—not the health care system or even the public health community—must be in charge of health. This may be the biggest challenge for those of us in government or the health care system because it will require a culture change in how we do our work. We can start the discussion but we cannot fully steer it. We must listen to and learn from community voices, even as we ask them to expand their own perspectives. This collaboration and sharing of ideas may be the most challenging of all the elements in the Triple Aim of Health Equity, but it will be the most important factor
Figure 1.
Triple Aim of Health Equity Implement a Health in All Policies approach with health equity as the goal Strengthen the capacity of communities to create their own healthy future Expand our understanding of what creates health
Implement Health in All Policies
Strengthen community capacity
Expand our understanding of health
Physicians get fatigued by a constant presumption that they can eliminate all health problems.
of Health Equity recognizes that many other partners are needed to advance health equity in our communities. Achieving health equity and optimal health for all requires inviting federal, state, and local government officials from “non-health” agencies and nonprofits and community groups focused on such issues as transportation, education, law enforcement, housing, agriculture, criminal justice,
as we work to advance health equity and help all people in our country achieve their full health potential.
Edward Ehlinger, MD, MSPH, was
appointed by Gov. Mark Dayton in 2011 to serve as the commissioner of the Minnesota Department of Health, the state’s lead public health agency. The commissioner is board-certified in both internal medicine and pediatrics.
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NEUROLOGY
Diagnosing autoimmune encephalopathies, dementias, and epilepsies The role of neural-specific autoantibodies By Andrew McKeon, MB, BCh, MD; Sean J. Pittock, MD; and Vanda A. Lennon, MD, PhD
W
ith the exception of multiple sclerosis (MS), disorders affecting the brain have traditionally been considered to be “no hope” diagnoses. Scientists and clinicians believed that the immune system did not have a major role in neurological diseases, because the nervous system had “immune privilege.” Early clues that this may not be true in all patients, included clinical observations of corticosteroid-response among patients with rapidly progressive cognitive decline and a history of autoimmune thyroid disease (Hashimoto encephalopathy) or systemic lupus erythematosus
(neuropsychiatric lupus). This concept has been confirmed and expanded on over the last three decades with the discovery of nervous system-specific antibodies of immunoglobulin G isotype (IgG). Many disorders of the central nervous system (CNS) previously considered neurodegenerative and untreatable are now recognized as having an autoimmune cause (Flanagan, et al., 2010; Quek, et al., 2012). Some disorders may be triggered by occult systemic cancer (paraneoplastic) or infection (parainfectious), though the causes in many instances are still unknown.
Neurological autoimmunity Autoimmune disorders of the CNS may be paraneoplastic (occurring in the setting of an occult systemic cancer) or idiopathic. Improved recognition of these disorders has been facilitated by an expanding profile of neural-specific autoantibodies discovered and validated for clinical use in academic neuroimmunology laboratories. When detected in serum or cerebrospinal fluid (CSF), these immunoglobulin G (IgG) biomarkers reliably predict an autoimmune cause for neurological dysfunction in patients presenting with rapidly progressive brain disorders. New testing profiles relevant to the evaluation of three neurological disease states (autoimmune encephalopathy, dementia, and epilepsy) are now available. Testing profiles, available for both serum and CSF, include neural antibodies that have been clinically validated as biomarkers of these three disorders (see Table 1). Negative results for these antibodies do not exclude an autoimmune basis for encephalopathy, dementia, or epilepsy, so in seronegative cases, a diagnostic trial of immunotherapy should be considered.
Epidemiology Precise frequency data for autoimmune encephalopathies, dementias, and epilepsies are not available. These disorders are clearly under-recognized. A recent review of over 1,000 brain autopsy cases referred as Creutzfeldt-Jakob disease to the United States National Prion Disease Pathology Surveillance Center demonstrated a treatable cause for dementia in 7 percent of cases (Chitravas, et al., 2011). Most common among these treatable dementia cases were autoimmune disorders. Among Mayo Clinic patients diagnosed with and treated for autoimmune encephalopathy or dementia, 35 percent were initially misdiagnosed with a neurodegenerative disorder (Flanagan, et al., 2010). Symptoms and other clues from the clinical history Symptoms are almost always of subacute onset (evolving over days to weeks). Encephalopathies, typically characterized by confusion, seizures, memory loss, and behavioral change, traditionally have been well recognized by neurologists as having an autoimmune cause. In contrast, patients with recent-onset idiopathic epilepsy or rapidly
Test Name
Encephalopathy, Autoimmune Evaluation, Serum Encephalopathy, Autoimmune Evaluation, Spinal Fluid Dementia, Autoimmune Evaluation, Serum Dementia, Autoimmune Evaluation, Spinal Fluid Epilepsy, Autoimmune Evaluation, Serum Epilepsy, Autoimmune Evaluation, Spinal Fluid T able 1. New testing profiles for evaluation of autoimmune encephalopathy, dementia, and epilepsy available. Source: Test catalog at Mayo Clinic and Mayo Medical Laboratories.
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Autoimmune Encephalopathy or Dementia
Autoimmune Epilepsy
Subacute onset
Acute to subacute onset
Fluctuating course
Multiple seizure types or faciobrachial dystonic seizures
Tremor
Antiepileptic drug resistance
Headache
Viral prodrome
Hypometabolism on functional imaging (PET)
Hypermetabolism on functional imaging (PET)
Features Common to All
Personal or family history (first-Âdegree relative) of autoimmunity History of recent or past neoplasia E vidence of central nervous system (CNS) inflammation from cerebral spinal fluid (CSF) (elevated protein, pleocytosis, oligoclonal bands, positive CSF index) E vidence of CNS inflammation from MRI (mesial temporal or other regional T2 hyperintensity) Detection of neural autoantibody T able 2. Clinical and laboratory features suspicious for an autoimmune encephalopathy, dementia, or epilepsy. Source: Flanagan, et al., 2010; Quek, et al., 2012
progressive dementia without delirium have usually been classified as having an underlying genetic or neurodegenerative cause. Clinical features suspicious for an autoimmune cause of encephalopathy, dementia, or epilepsy are outlined in Table 2. Limbic encephalitis is the classically recognized autoimmune encephalopathy syndrome. It is characterized by a confusional state with loss of orientation (delirium), and usually occurs with one or more signs of cognitive decline (generally memory problems), seizures, altered mood and personality, and sleep disorders. Magnetic resonance imaging (MRI) of the head often reveals T2 signal abnormality in one or both hippocampal regions. Electroencephalogram (EEG) may reveal unilateral or bilateral temporal slowing or epileptiform discharges. The main excludable differential diagnosis is viral encephalitis caused by herpes simplex virus. Encephalitis may also have an extratemporal localization, affecting one or more of the frontal, parietal, and occipital regions (McKeon, et al., 2009) Autoi m mu ne dement i a phenot y p e s m ay r e s emble Cr eut z feldt- Ja kob d i s e a s e,
which classically is a rapidly progressive neurodegenerative disorder accompanied by ataxia and myoclonus. Rapidly progressive forms of Alzheimer disease and diffuse Lewy body disease also are difficult to distinguish clinically from an autoimmune dementia. Tremulousness and headache at presentation, marked fluctuations
brain origin rather than generalized seizures. The seizures are usually resistant to two or more standard antiepileptic medications. A mesial temporal (limbic) onset focus is most common, but extratemporal and multifocal seizure localizations have been described. Additional less prominent manifestations may include memory and cognitive difficulties, personality changes, and depression or anxiety. In addition to the time course, clues to an autoimmune diagnosis include a personal history of cancer or autoimmunity (e.g., autoimmune thyroid disease, insulin dependent diabetes, systemic lupus erythematosus, rheumatoid arthritis, or vitiligo). Smoking history, review of systemic symptoms, and a family history of autoimmunity or cancer might also be informative. Examination findings Impairments in one or more categories of attention, memory, reasoning, calculation, and
executive function can be documented using brief bedside evaluations such as the mini-mental state examination (MMSE), or the Kokmen short test of mental status. A seizure may be witnessed by the examiner. Autoimmune neurological disorders are often multifocal, thus it is important to note any subtle neurologic symptoms and signs accompanying cognitive impairment or seizures. These signs may include ataxia, brainstem abnormalities, Parkinsonism, myoclonus, tremor, myelopathy, or a peripheral nervous system disorder. Testing for markers of an autoimmune diagnosis Though neural IgG antibody tests are the focus of this article, seronegativity does not exclude an autoimmune diagnosis that other clues may help.
Diagnosing autoimmune encephalopathies, dementias, and epilepsies to page 22
An autoimmune encephalopathy, dementia, or epilepsy may be a byproduct of an immune response directed against a systemic cancer.
in the clinical course, and spontaneous remission suggest an autoimmune cause (Flanagan, et al., 2010). Patients with autoimmune epilepsy may present with seizures alone or with a seizure-predominant disorder (Quek, et al., 2012). All patients reported to date have had seizures of focal or multifocal NOVEMBER 2016 MINNESOTA PHYSICIAN
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Diagnosing autoimmune encephalopathies, dementias, and epilepsies from page 21
Neural-specific autoantibody profiles Detection of one or more neural autoantibodies in serum or CSF is consistent with a diagnosis of an autoimmune encephalopathy, epilepsy, or dementia, and helps direct a search for cancer. Screening tests for these autoantibodies include immunofluorescence and immunoprecipitation assays. In some instances, reflex testing may be indicated to confirm antigen specificity (by Western blot) or to quantitate an endpoint value or titer. The testing algorithms for the three disease states are similar. Oncological accompaniments
of the individual autoantibodies are detailed in Table 3. Some autoantibodies are more readily detected in serum (e.g., voltage-gated potassium channel [VGKC]-complex IgG) and others in CSF (N-methyl-D-aspartate [NMDA] receptor antibody). Therefore, the diagnostic yield is maximized by testing both serum and CSF, simultaneously or sequentially (McKeon, et al., 2011). Diagnostic clues from conventional serum and CSF testing Seropositivity for nonneural antibodies warrants detailed investigation for an autoimmune pathogenesis for encephalopathy, dementia, or epilepsy. Informative nonneural autoantibody specificities may be organ-specific (such as thyroid autoantibodies) or
nonorgan-specific (such as antinuclear, anti-smooth muscle, or anti-mitochondrial antibodies). However, these markers per se lack specificity for neurological autoimmunity. In addition, the detection in CSF of elevated protein, white blood cell count, CSF-exclusive oligoclonal bands,
Oncological significance In many instances, an autoimmune encephalopathy, dementia, or epilepsy may be a byproduct of an immune response directed against a systemic cancer. A paraneoplastic autoantibody profile reliably predicts the cancer type. In contrast, serolog-
Antibody values tend to decrease with immunotherapy regardless of outcome. IgG index or IgG synthesis rate also supports an autoimmune etiology. However, these parameters also lack specificity for an autoimmune cause, and may be detected in other inflammatory CNS disorders for which there are no specific biomarkers (e.g., multiple sclerosis, sarcoidosis).
Neuronal Nuclear & Cytoplasmic Antibodies
Plasma Membranes Antibodies
Antibody
Oncological association
Antibody
Oncological association
ANNA-1
Small- cell lung carcinoma, neuroblastoma
VGKC-complex (LGI1 CASPR2, or other specificity)
Small- cell lung carcinoma, thymoma, adenocarcinoma of breast, prostate
ANNA-2
Small- cell lung carcinoma, breast adenocarcinoma
NMDA receptor
Teratoma (ovarian or extra-ovarian)
ANNA-3
Aerodigestive carcinomas
AMPA receptor
hymic epithelial neoplasm, T lung carcinoma, breast carcinoma
AGNA/SOX1
Small-cell lung carcinoma
GABA-B receptor
Small- cell lung carcinoma, other neuroendocrine neoplasm
PCA-1
Mullerian (ovary, fallopian tube, uterus) adenocarcinoma, breast adenocarcinoma
P/Q and N-type calcium channel
Small- cell lung carcinoma, breast or gynecological adenocarcinoma
PCA-2
Small-cell lung carcinoma
Muscle AChR
Thymoma, thymic carcinoma, lung carcinoma
PCA-Tr/DNER
Hodgkin lymphoma
Neuronal ganglionic AChR
Miscellaneous adenocarcinomas, thymoma, small-cell lung carcinoma
CRMP5 IgG
Small- cell lung carcinoma, thymoma, thyroid, or renal carcinoma
NMO (AQP4)-IgG
Occasionally breast carcinoma, thymoma, lymphoma, or other neoplasm
Amphiphysin IgG
Small- cell lung carcinoma, breast adenocarcinoma
DPPX-IgG
B cell neoplasms
GAD65
hymoma; renal cell, breast T or colon adenocarcinoma
mGluR1-IgG
Lymphoma
ical and oncological associations are not readily predicted by the neurological phenotype (Pittock, et al., 2004). Thus, algorithmic testing for autoantibody profiles is a more sensitive diagnostic strategy than nominal physician-selected single antibody testing. For example, seropositivity for amphiphysin IgG predicts either small cell lung carcinoma or breast adenocarcinoma, but the presence or absence of coexisting antibodies narrows that differential diagnosis. Among 63 Mayo Clinic patients with amphiphysin antibody and a known history of cancer, 33 had small-cell lung carcinoma. Of those patients, 27 had one or more coexisting neural-specific autoantibodies that also predicted small-cell lung carcinoma. In contrast, no coexisting autoantibody was detected among 30 amphiphysin-IgG-positive patients in whom breast adenocarcinoma or other cancer type was found (McKeon et al., 2009). The frequency of cancer detection in antibody-positive patients (pulmonary or extra-pulmonary small-cell lung carcinoma in almost all cases) varies from 20 percent for VGKC complex IgG to 80 percent for antineuronal nuclear antibody type 1 (ANNA1). Suspicion for a paraneoplastic cause may be raised by risk factors obtained from the clinical history. This suspicion may be honed to a search for a specific cancer based on the profile of autoantibodies detected. A
T able 3. Oncological accompaniments of neural autoantibodies. bbreviations: ANNA, anti-neuronal nuclear antibody; PCA, Purkinje cell cytoplasmic antibody; CRMP5, collapsin response-mediator protein-5; GAD65, glutamic acid decarboxylase; A VGKC, voltage-gated potassium channel; LGl1, leucine-rich, glioma inactivated 1; NMDA, N-methyl D-aspartate; AMPA, α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid; GABA, gamma-aminobutyric acid; AChR, acetylcholine receptor; NMO (AQP4), neuromyelitis optica (NMO)/aquaporin-4; DPPX, dipeptyl-peptidase-6; mGluR1, metabotropic glutamate receptor, type 1. Source: Unpublished Mayo Clinic data. Mayo Clinic Neuroimmunology Clinic. Pittock SJ. May 2014.
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thorough physical examination and computerized tomography (CT) of chest, abdomen, and pelvis are commonly undertaken as primary screening tests. Other tests may be required depending on age, sex, and other risk factors. Pelvic ultrasound (including transvaginal imaging) or MRI and gynecological examination are required to evaluate for ovarian carcinoma or teratoma. Mammography and breast examination are required to evaluate for breast carcinoma. Testicular ultrasound, prostatespecific antigen testing, and prostate examination by digital rectal examination are required to evaluate for testicular and prostate carcinomas, respectively. When neuroblastoma is suspected, and CT body imaging is negative, a radiolabeled metaiodobenzylguanidine (MIBG) body scan should be considered. Endoscopic examination of the upper and lower gastrointestinal tracts and bronchial tree should also be considered where appropriate. Positron emission tomography (PET) co-registered with CT (PET-CT) imaging increases the diagnostic yield by 20 percent for patients in whom standard evaluations have not revealed cancer (McKeon, et al., 2010). Implications for treatment The profile of antibodies detected (see Table 3) may guide immunotherapy and be informative for neurological prognosis (McKeon, et al., 2011). Studies suggest that autoimmune neurological disorders for which the antigens of marker IgG antibodies are intracellular are caused by neural peptide-specific CD8-positive cytotoxic T cells. An example includes encephalitis occurring in patients seropositive for ANNA-1. This autoantibody predicts with 80 percent certainty the presence of small-cell lung carcinoma. The target antigen is nuclear and, therefore, inaccessible in intact cells to circulating antibody. The neurological deficit rarely improves with antibody-depleting or tumoricidal therapies. On the other hand, IgG antibodies targeting neural cell surface receptors and channels
do have a pathogenic role in effecting autoimmune CNS disorders that may be improved by antibody-depleting immunotherapy. For example, patients with antibodies targeting the GluN1 subunit of the NMDA ionotropic glutamate receptor present clinically with encephalopathy that improves (sometimes completely) with early teratoma removal and antibody-depleting and immunosuppressant therapy. Serial trial of corticosteroids, intravenous immune globulin, and plasma exchange are considered first-line treatments to establish immunotherapy responsiveness. Some patients, such as those with autoimmune NMDA receptor encephalitis, may require many months of treatment. Immunosuppressants such as rituximab or cyclophosphamide may be required to maximize recovery.
Rapid diagnosis is facilitated by testing for neural-specific autoantibody profiles in serum and CSF. When detected, one or more positive antibody results may direct the cancer search and prompt the timely initiation of immunotherapy.
Sean J. Pittock, MD, is professor of
Andrew McKeon, MB, BCh, MD, is professor of neurology in the College of Medicine at the Mayo Clinic in Rochester. He is co-director of the Mayo Clinic Neuroimmunology Laboratory, and director of the Autoimmune Neurology Fellowship Program.
Vanda A. Lennon, MD, PhD, is The Dorothy A. Adair Professor in the Departments of Laboratory Medicine and Pathology, Neurology and Immunology at the College of Medicine at the Mayo Clinic. She is also founder of the Mayo Clinic Neuroimmunology Laboratory.
neurology in the College of Medicine at the Mayo Clinic in Rochester and director of the Mayo Clinic Neuroimmunology Laboratory. He is the Marilyn A. Park and Moon S. Park, MD, director of The Mayo Clinic Center for Multiple Sclerosis and Autoimmune Neurology.
Treatment monitoring A ntibody va lues tend to decrease with immunotherapy regardless of outcome, and have a limited role in the adjudication of a treatment trial. However, a rise in antibody titer from a post-treatment baseline, accompanied by neurological deterioration, may indicate relapse of the autoimmune neurological disorder or a persistent systemic c a nc er. Obje c t ive cl i n ic a l, behavioral, neuroradiological, or electrophysiological measures undertaken pretreatment may be compared to posttreatment findings. Testing recommended for this purpose includes clinical examination, brain imaging (structural [MRI] or functional [PET]), detailed (four hour) neuropsychological testing, and EEG. Resolution of neuropsychologica l, EEG, MR I, or f unctiona l imaging abnor ma lities af ter immunotherapy supports improvements and supports treatment continuation. Summary It is critically important to recognize treatable and potentially reversible autoimmune encephalopathies, dementias, and epilepsies in neurological practice. NOVEMBER 2016 MINNESOTA PHYSICIAN
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I
t would be nearly impossible to buy a major newspaper in the last six months and not find at least one article regarding our nation’s current opioid crisis. In 2014, there were 47,055 drug overdoses in the U.S. with 28,647 due to opioids. Opioids as a cause of death has increased an astounding 200 percent from 2000–2014, according to the CDC. Nearly 600 drug overdoses occurred in Minnesota from 2014 to 2015 and sadly, our small community of Little Falls, played its part in that statistic. In late 2014, our Morrison County Drug Task Force (MCDTF), which had not met in a number of years, reconvened. Members came from all parts of our community including school staff, county officials, clinic and hospital staff, law enforcement, and community activists. The goal of the task force was to collaborate with and educate our community about the opioid epidemic. The open communication and exchange of information allowed us to focus on the
Morrison County Drug Task Force Battling opioid addiction in Greater Minnesota By Kurt Devine, MD, and Heather Bell, MD
most at-risk population. Initially, our opioid problem looked overwhelming. Local physicians and advanced practice clinicians (APCs) were overwhelmed with chronic pain patients, estimated to be around 500. Our ER was flooded with complaints of pain, making it the most common reason for an ER visit; and law enforcement reported finding prescription bottles in the wrong hands, frequently at the scenes of crimes. Clinically, chart reviews showed limited use of the prescription monitoring
program (PMP), pill counts, or urine testing. Few patients had current medication agreements, and of those who were being monitored, many had misinterpreted urine screenings. It seemed unlikely that anything we did could make a significant difference, however months later, data showed a measurable impact and that we were changing the course of opioid use in our county. It is our hope that the program we implemented can guide other rural communities to improve prescribing and
statistics showing that greater than 30 percent of their clients had received more than eight prescriptions for narcotics in the preceding eight months. Our electronic medical records (EMR) allowed us to identify the target population and begin our work. We attempted to research programs relating to care coordination for chronic narcotic patients and found no guidelines or useful roadmaps, so we realized we would have to build a program from scratch. We started by allocating grant money to hire an RN to help manage the program and aid in development. She helped physicians and APCs obtain signed medication agreements, set up pill counts, and ordered and interpreted urine drug screens. Although our physicians had good intentions to do these things themselves, time constraints seemed to limit how well patients were monitored. The nurse set up a database of narcotic patients and assumed responsibility for these tasks.
ER visits for pain dropped from our No. 1 presentation to not even appearing in the top 20.
monitoring of opioids as well as provide education on medical-assisted treatment for those patients dependent on prescription opioids and heroin. Getting started CHI St. Gabriel’s was awarded a SIM Grant just as our program was getting started. The funds were used to subsidize two years of developing a care-coordination model to help our clinic and hospital more closely monitor patients receiving chronic narcotics. Clinic data showed that of the 500 patients currently on chronic opioids, a majority of these patients were Medicaid recipients. Our Medicaid provider, SCHA (South Country Health Alliance), had
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When meeting with each patient, she also obtained medical information releases from a patient’s previous clinics, checked the PMP, found the diagnosis for their pain medication, reviewed their history of therapy and pain clinic referrals, and performed a DIRE risk assessment to better define if a patient was at high risk to divert or misuse narcotics. The second addition to our team was a pharmacy resident who participated in collaboration with our local Coborns Pharmacy. He started by reviewing narcotic dosing and assessed possible interactions, especially in patients also taking Benzodiazepines. Finally, he reviewed all of our urine drug screens and
confirmatory testing in an effort to simplify ordering and aid in interpretation. The flow charts for ordering and interpreting the results proved invaluable. The final team addition, and likely the most important, was our social worker. She assessed the patient’s family’s history and current living conditions while reviewing previous drug and alcohol abuse, treatment history, and previous incarcerations, arrests, and convictions focusing on drug-related offenses. Even when circumstance required that a patient’s medication be tapered, our goal was and is to provide opportunity for optimal treatment, counseling, and/or other services that improve their care. We did not want our program to be punitive. Developing a plan After each member of the team had either met with the patient or reviewed the available information, the team discussed the patient at weekly meetings. Our team of physicians reviewed scans, pertinent medical records, as well as urine drug screens. A plan specific to each patient was formulated and recommendations were relayed to the patient’s PCP by our nurse with monitoring managed through the team. In cases when there was significant concern regarding diversion or misuse, a physician team member met directly with the provider to help get more aggressive monitoring in place. Patients with a history of demanding behavior, frequent lost or stolen pills, and those on unusually high doses of narcotics were also specifically enrolled. This group, as expected, yielded a high percentage of failed urine tests, evidence of doctor shopping, and symptoms/diagnosis inappropriate for chronic narcotics. The majority of this group no longer receives narcotics in our clinic. Seeing results N e a r l y 3 0 0 p at ie nt s we r e enrolled in the 18 months we have been active, with nearly 113 not currently receiving
prescription narcotics. Of those still getting narcotic prescriptions, attempts have been made to get patients to a minimally effective dose through the use of pain modulating medica-
including difficulty finding mentors and the burdensome prior authorization process with our medical assistance program and other insurers. The ability to get the medication when it’s most
The program we implemented can guide other rural communities.
tions, physical and occupational therapy, as well as addressing mental health issues and other socioeconomic stressors. This effort dropped the narcotic prescriptions from one of our four local pharmacies by roughly 20 percent in 10 months. After only six months, our program saved our Medicaid provider over $400,000 in claims over the same period last year. Decreased pharmacy and clinic visits, as well as fewer ER visits appear to be significant factors in our savings. ER visits for pain dropped from our No. 1 presentation to not even appearing in the top 20 in that same time period.
needed is mired down in phone calls, paperwork, and delays in processing. Ironically it is very easy to continue prescribing the narcotics that began this epidemic but much more difficult to obtain the medication to fight it. Conclusion Overall, our program is forever adapting to the different needs that arise, and this is a very brief summary of what we have done and continue to do. We are encouraged by an apparent
culture change in the way physicians and our community perceives the treatment of chronic pain, the use of prescription opioids, as well as medically-assisted treatment using medications such as Suboxone. With the help of U.S. Congressman Rick Nolan, we were honored to speak at a congressional briefing in Washington, D.C. in an attempt to get additional funding for our project so we can begin sharing what we have learned with other physicians and clinics. I believe we can show that the opioid epidemic, which plagues our rural communities, can be defeated with time and effort, but as with most things, “It takes a village.”
Kurt Devine, MD, is a board-certified
family physician with CHI St. Gabriel’s Health–Family Medical Center. Heather Bell, MD, is a board-certified family physician with CHI St. Gabriel’s Health–Family Medical Center.
An unforeseen problem Despite all we did during that first year, we still had two overdose deaths in our community, one from prescription drugs and one from heroin. We naively perceived heroin as a minor issue, however, our law enforcement partners educated us about it as a mounting problem. After attending the National Prescription Drug and Heroin Conference in Atlanta, we were convinced that caring for our opioid-dependent patients who had turned to heroin was the next step for our program and we obtained our DEA certification waivers to prescribe and administer Suboxone. Suboxone is a partial opioid agonist and widely used to treat narcotic addiction. There are an estimated 100–200 heroin addicts in our county and to date we have addressed fewer than 10. There are many barriers to enrolling and caring for these patients,
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hose of us who practice rural medicine are important contributors to the health and economies of our community, but the challenges facing us now have become ever more daunting. As health care transforms to value-based reimbursement, it is causing us to redirect some of our focus away from patient care. Our task is to understand the new requirements, address them, and create new workflows to meet these requirements. The driving force is to reward providers, like us, for cost effective, high quality, and efficient care that is best for our patients and community rather than simply services delivered. This change is already underway, and thriving in this new environment will require us to transform how we do business Va lue essentia lly means getting something of high quality at a reasonable cost. For value-based reimbursement, if we can demonstrate that we provide high-value care, our
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Rural medicine and value-based reimbursement How to survive and thrive By Paul Kleeberg, MD reimbursement is greater. Value-based reimbursement is not merely a measurement of what I do with my patient in my practice but what happens to my patient throughout all aspects of their care, whether it is in my practice, the hospital, the rehabilitation center, or with our referral partners or home care. I share in the responsibility for the cost and quality of not only what I do, but for what others do with my patient. In order to be able to manage these activities I must be aware of what goes on
MINNESOTA PHYSICIAN NOVEMBER 2016
outside of my practice to assure that my patient is getting efficient and effective care. The increasingly complex environment This transition is forcing rural physicians to meet an increasing number of requirements. For independent practices there has been meaningful use, the physician quality reporting system, and the value-based payment modifier. Those who practice in rural health clinics or in federally qualified health care centers have been exempt from some of these requirements but not all. They have their own reporting requirements and though they are not currently subject to a value-based payment modifier, there is a clear indication that Congress will move to apply value-based reimbursement to them as well. All of these new reporting requirements are stressing the limited resources of small and rural practices, when they were meant to improve quality and transparency. In some ways they have succeeded, but unintended consequences have resulted as well. A recent commentary in the Wall Street Journal written by Bob Kocher, MD, one of the framers of the Accountable Care Act admitted that he believed that consolidation was going to reduce costs and increase quality. In that commentary, he said that assumption is not bearing out. Instead, consolidation appears to be increasing costs. In a recent blog by the former head of the Office of the National Coordinator of Health Information Technology, Dr. Farzad Mostashari pointed out
that “Recent evidence suggests that small physician-owned practices while providing greater level of personalization and responsiveness to patient needs have lower average cost per patient, fewer preventable hospital admissions, lower admission rates than larger, independent and hospital owned practices.” A number of my rural colleagues have said they believe that the overall complexity of this transition will create a need for consultants to guide small and rural practices through the process. One of the biggest barriers for rural practices is knowing what to do in the first place. These consultants are likely to be costly and therefore diminish any potential financial benefit of the new payment model further straining these providers. The aging population Another challenge for rural providers is that their population is aging and many of them are dependent on Medicare. Older patients by their nature are more costly and require more care. Because of this high share of Medicare patients, their reimbursement is lower than their suburban and urban colleagues and is impacted more by Medicare program requirements. Technology Effective use of information technology is key in this new environment. I have visited many rural practices over the years: from places throughout Minnesota and North Dakota, to the hills of West Virginia to the back roads of the Mississippi Delta. Many of the towns I’ve visited are isolated—hours from an urban area. For these providers, effectively using EHRs is challenging for various reasons. For starters, many of these physicians are older and have been in practice for many years. Because they have developed their workflows over years of refinement, adapting to new technologies and new requirements has been challenging and disruptive. And because of their location, it’s difficult to find staff or local support with the technical skills to maintain and optimize health technology
with new work flows, customize clinical decision support, and build templates to collect the data they need for reporting. There are also barriers to integrating information from within their own ambulatory and hospital facilities, not to mention health information exchange with distant referral facilities. All too often, the patient’s primary care provider is not aware of a patient’s hospitalization until they come in for a visit. To succeed in value-based care, the integration of internal and external information is critical for success.
a loss of independence. Though the burden of reporting under the new Medicare Access and CHIP Reauthorization Act (MACRA) requirements may be eased, it is not likely to lead to financial gain. According to the new regulations, providers who choose to remain in the fee-forservice world will see a lower
Ways to adapt In our state, many practices have chosen to join large organizations. These organizations have the resources to provide the technology and reporting capabilities that the new regulations require. This relieves the providers of some of their reporting burdens and potentially provides them with additional resources. However, this often comes with
rate of increased reimbursement under Medicare than those who choose to participate in an advanced payment model. If a practice is interested in competing in the new marketplace, they would do better to participate in an advanced payment model such as an accountable care organization (ACO). In an accountable care Medicare Shared Savings Program
(MSSP) there is the opportunity to gain increased reimbursement when providing higher quality, cost effective care. The MSSP can provide you with greater access to information about your patients so that you are more aware of what is going on with them outside of your office. You also have a greater
All of these new reporting requirements are stressing the limited resources of small and rural practices. ability to intervene so that patients will receive the right care from the right specialists. For some practices, joining a large ACO may be the best option. If they only use one hospital or one network of hospitals and specialists, joining that ACO is a reasonable choice. But for practices that do not have a defined referral network to a particular facility or who wish
to maintain their independence, forming an ACO with your peers is likely to be a better option. Recent data published in the New England Journal of Medicine showed that savings were greater in independent primary care groups than in larger hospital integrated groups. This is still a difficult transition for smaller independent practices to make. One’s success depends on the success of the group as a whole and as one colleague put it: “These practitioners are relatively independent as a choice and will be reluctant and wary about joining virtual groups to participate in MACRA. They will be concerned about the many variables that are no longer under their control. There will be the potential for blame and ‘finger pointing’ at practices that are below established goals leading to potentially fractious relationships within a virtual group.” The same would hold
Rural medicine and VBR to page 40
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hen people from outside the area think about Minnesota and North Dakota, what industry comes to mind? Retail? Health care? For many, the answer may be agriculture. Minnesota consistently ranks among the top in the nation in the production of turkeys, hogs, corn, sugar beets, wild rice, and peas. But what happens to those who help with the planting, care, and harvest of those crops?
Health care for migrant and seasonal farm workers
Serving those in need Community Health Service Inc. (CHSI), known as Migrant Health Service, Inc. until 2014, was established in 1973 to provide primary health care services to migrant and seasonal farmworkers and their families. The number and location of seasonal, mobile, and yearround clinics has changed many times over the last four decades, but the dedication to serving the underserved has not. The administrative office and a year-round clinic are located
By Kristi Halvarson, MHA
Caring for the underserved
in Moorhead, Minn. Additional year-round clinics are in Rochester, Willmar, Minn., and Grafton, N.D. A year-round mobile medical unit operates within approximately a 60-mile radius of Rochester. A seasonal clinic also opens in Owatonna, Minn. during the summer, typically June–September. CHSI is one of approximately 1,370 health centers across the United States supported by
federal grants from the Health Resources and Services Administration (HRSA), 17 of which are located in Minnesota. Nationwide, over 24 million patients were seen at health centers in 2015. Two primary features distinguish health centers from traditional health care providers: 1) Comprehensive primary care services are provided on a sliding fee scale and no one is turned away due to their inability to pay; and 2) Health centers are governed by a board of directors, the majority of whom must be patients that use the health center’s services. This community-based approach enables patients and other stakeholders to make decisions that impact service delivery and, ultimately, the health of the overall communities where they live and work. Health centers are also subject to regular oversight to ensure solid clinical and financial performance. CHSI was one of almost 1,300 health centers recognized for high-quality care earlier this summer for achieving Patient Centered Medical Home (PCMH) recognition, notable improvement in at least one clinical quality measure, and being a health center quality leader when compared to its peers. Patient needs Patients at CHSI are not what many would consider to be a “typical” patient throughout most of Minnesota. In 2015, 88 percent of patients were Latino, 89 percent did not have health insurance, 67 percent were best
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served in a language other than English (predominantly Spanish), and 57 percent had household incomes less than 100 percent of the federal poverty level, or $24,250 for a family of four. Language needs, transportation, social isolation, and socioeconomic status are consistently the biggest barriers confronting these patients. Mobile patients who follow the planting and harvest of crops face additional challenges with continuity of care. It is not uncommon for a farmworker to regularly seek care at CHSI during the summer months and get his/her diabetes under control only to return to their home base, not be able to access care, and return in the spring with a hemoglobin A1c of 12 or more. What designates a migratory farmworker? About 1 in 4 of our patients are considered a migratory farmworker—one who travels specifically for purposes of employment in agriculture. Seasonal farmworkers consist of another 35 to 40 percent of CHSI’s patient base in recent years. Individuals who currently perform agricultural work, who have done so as a principal source of income in the past 24 months, or who reside in the same household as someone who has, are all considered to be agricultural workers. A common misconception is that agricultural workers are all Latino, only speak Spanish, or always travel. For our purposes, however, John Smith who works the sugar beet or potato harvest qualifies the same as Juan Gonzalez would. A number of our farmworker patients are Somali, and we have routinely done home visits to Amish communities around the Rochester area for several years. Agriculture is defined slightly differently depending on which federal agency administers the program. For example, someone who qualifies as an agricultural worker for health purposes may not necessarily qualify for migrant legal or migrant education services. Generally speaking, however, agriculture consists of occupations dealing
with crop or animal production. Turkey farms are considered agricultural work, but the turkey processing plants are not. The vast majority of CHSI’s migrant farmworkers hail from south Texas, but an increasing number come from Guatemala and other Central American countries. Although Spanish is common among many of these individuals, there is a growing number of different dialects and indigenous languages presenting to the clinic. Going beyond medical care CHSI strives to address more than just the medical needs of the patient, recognizing that achieving health requires a broad approach. A migrant farmworker who has just relocated to an area he/she is unfamiliar with, can’t find housing, and hasn’t secured employment yet is often in “survival mode” and is less focused on healthy eating and exercise to control their diabetes. Helping the patient reach a state where health can be a priority is a daily occurrence and requires extensive communication between clinical and front office staff. In addition to medical services, mobile dental care is provided with the help of community dental providers who travel from site to site three to four Fridays per month from about March–October. Victim advocacy staff in Moorhead and at an office in Crookston provide support and assistance
MNsure. Outreach also involves meeting the patient where they are—either in terms of where they are physically located, or relative to a specific patient’s individual needs. CHSI staff conduct home visits for patients unable to come to the clinic. Staff regularly connect patients with food, housing, social, and legal resources to help address their situation. Despite a high rate of uninsured patients, we saw the number of patients covered by Medicaid more than double from 4 percent in 2013 to just over 9 percent in 2015. This is largely due to the hard work of CHSI’s outreach and enrollment staff, and was a positive impact of the Affordable Care Act. Fiscal and operational challenges unlike those we have in recent memory are likely given the uncertainty surrounding the permanence of the ACA and Medicaid expansion, combined with the many questions about how payment reform will impact health care financing and service delivery.
can be drawn and sent to a reference lab. A wide range of primary care services are available to patients, including chronic disease management, women’s health, immunizations, and acute care. Most of our patients have at least one chronic condition, typically obesity, hypertension, or diabetes. Collaboration is a crucial component of our mission. Staff are very active in state and regional primary care associations that offer training and technical assistance and advocate for policy change at the state and national levels. Quality improvement efforts are aided by involvement in a Health Center Controlled Network (HCCN) that provides peer learning opportunities and joint support for health information technology infrastructure. CHSI relies on its relationships with community providers to facilitate access to pharmacy, dental, and imaging services as well as additional medical and specialty care. Extensive connections
with public health and community organizations allow us to address some of the social determinants of health that can negatively impact patient outcomes. Perhaps most important, however, are the daily interactions of staff with patients and neighbors to gain insight into what the needs of the community are. There is a demonstrated need to provide access to affordable, high-quality care to all individuals in the community, especially those who are uninsured or underinsured. CHSI is looking forward to the opportunity to build on that experience to serve the general community. After more than 40 years, however, agricultural workers and their families will always be at the core of CHSI and its identity.
Kristi Halvarson, MHA, is executive director of Community Health Service, Inc. a nonprofit organization that caters to the needs of seasonal farm workers.
The CHSI workforce Clinical sites are managed by registered nurses. A mix of nurse practitioners, physician assistants, and physicians provide care to patients in a teambased model that collaborates closely with an RN and clinical assistant. Bilingual front office staff are employed at each location for patient registration, outreach and enrollment, and inter-
Patients who follow the planting and harvest of crops face additional challenges with continuity of care.
to victims of domestic violence and sexual assault, whether that means taking calls on a 24/7 bilingual crisis line, filing orders for protection, or providing temporary hotel assistance so victims can leave their situation. Outreach and enrollment staff assist patients and community members to apply for Medicaid or insurance plans on
preting during patient visits. Many of the bilingual employees are former farmworkers themselves and can uniquely identify with our patients’ lifestyle and needs. Nurse education and case management historically have been at the heart of our service delivery and continue to be a large focus. CLIA-waived labs are performed onsite or labs NOVEMBER 2016 MINNESOTA PHYSICIAN
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ife is different in rural Minnesota. The conditions, challenges, landscape, and solutions require both greater understanding and more concerted, creative action. We all like to think of a rural Minnesota that resembles Garrison Keillor’s fictional Lake Wobegon, where all the women are strong, all the men are good looking, and all the children are above average—the “Up North” of legends where people are rugged and healthy with fresh air, clean water, and lots of outdoor exercise. This ideal was reflected in the Time magazine cover from the 1970s featuring a plaid-shirted Gov. Wendell Anderson holding up a stringer of fish with the slogan “The Good Life in Minnesota.” Yet, when it comes to health and health care, the reality does not fit the mythology. Rural health challenges While roughly half of our state’s population lives in Greater Minnesota (i.e., outside the
A shrinking rural health care workforce Addressing the challenge By Steve Gottwalt seven-county Twin Cities metro area), only one-sixth of our doctors practice there. In rural regions outside the Twin Cities metropolitan area, the average age is older, the average income much less, and the average health is worse. Studies by the University of Wisconsin and Robert Wood Johnson Foundation show the least healthy counties in Minnesota are “Up North,” along the northern quarter of our state. Rural health care providers are also older, on average, and
many are choosing to retire. Fewer young medical professions students are stepping-up to replace them. Where there is roughly one medical doctor for every 300 people in Minneapolis, there is only one doctor for every 2,000 people in deep rural portions of Minnesota. In the Twin Cities, specialists and ancillary providers abound. In most rural areas, you are lucky if you can see a specialist faceto-face without a long trip, a long wait, or both. You might have five or six hospitals within a half-hour drive of your location in the Twin Cities. In rural areas of our state, you may be hours from the nearest hospital, with fewer transportation options for getting there. Many small town critical access hospitals are in jeopardy of closing altogether. Every health care facility, from clinics and pharmacies to hospitals and nursing homes, is under greater pressure in Greater Minnesota. Population diversity While many think of rural Minnesota as mostly Caucasian with little cultural or ethnic diversity, many rural communities face the added challenges of delivering services to an increasingly diverse population. Latino, Somali, and other immigrants often require interpreters who are difficult to find in rural areas. American Indians, who represent nearly 3 percent of Minnesota’s population, face tremendous health challenges, including high rates of diabetes and suicide. There is also the cultural challenge of maintaining health
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and delivering health care among rural residents who are often reluctant to seek help or see a health care professional. Many have a hard time getting to medical appointments, a pharmacy for prescribed medications, or a grocery store for food and supplies. Distances, isolation, transportation challenges, and limited broadband access add to rural health challenges. Improving the health of Greater Minnesota A big part of my work with the Minnesota Rural Health Association (MRHA) is telling this story to people who can help make a positive difference and enlisting their efforts. MRHA is a private, non-profit, non-partisan membership organization missioned with strengthening the health and health care of rural Minnesota through leadership, education, advocacy, and collaboration. Our membership of more than 1,000 includes large regional health systems and small town clinics, hospitals and nursing homes, health care providers of all types, medical educators and students, patient advocates, emergency and non-emergency transportation providers, state agency and public health staff, aging services organizations, broadband providers, rural development organizations, and more. In the last two years, MRHA has identified the following priorities for action in strengthening rural health and health care. Topping the list is addressing our shrinking rural health care workforce. • Health care workforce shortages • Mental and behavioral health access • Home and community-based services (HCBS) workforce issues • Dental health access • Transportation • Broadband shortage • Reimbursement disparities • Hospitals, clinics, and nursing homes in crisis The Minnesota Medical Association (MMA), Minnesota Hospital Association (MHA),
and Minnesota Department of Health (MDH) all predict a Minnesota physician shortage of between 800 to a few thousand in both primary and specialty care. Fewer medical students are choosing primary care, while lack of funding, facilities, faculty, and the federal cap on residency slots are barriers to producing more rural health csare providers. Beyond educating a new generation of providers are the added challenges of attracting them to rural practices, including recruiting costs, growing pay disparities compared to urban practices, demanding call rotations, and finding good jobs for their spouses. Traditional approaches to boosting our rural health care workforce have included grant programs that help defray the cost of clinical rotations, and student loan forgiveness programs for those willing to practice in rural communities for a specified period of time. More recently, groups like the
Healthcare Education Industry Partnership (HEIP) and HOSA– Future Health Professionals have sponsored “Scrubs Camp” for high school students, intro-
needs of rural Minnesota and American Indian communities. A Stratis Health “Building Healthier Communities” grant is helping MRHA strengthen
While roughly half of our state’s population lives in Greater Minnesota … only one-sixth of our doctors practice there.
ducing them to health care professions at an early stage. Recently, MRHA launched a student chapter to help engage health care professions students in shaping the future of rural health. The first student chapter, with about 20 student members, is appropriately located on the University of Minnesota Medical School, Duluth campus. Since 1972, the U of M Duluth campus has been a leader in educating physicians dedicated to family medicine, and serving the health care
the student chapter at Duluth, and expand it to other Minnesota campuses educating future rural providers. Student chapter activities have included student poster presentations at the annual Minnesota Rural Health Conference; a new annual “MRHA Emerging Rural Health Leader Award” recognizing an outstanding Minnesota rural health student; and education in rural health advocacy. We hope this initiative helps encourage more careers in rural health care.
Creative solutions The increasingly critical need for rural providers has also spurred more creative solutions. Minnesota is looking at ways it can better assimilate new Americans (i.e., immigrants) who are medical professionals, many of whom come to Minnesota with strong medical education and experience. Policy makers have enacted legislation allowing different health care professionals to augment our diminishing rural primary care workforce. Minnesota was the first state in the nation to pass a law creating a community paramedic, and more recently a community emergency medical technician (EMT), allowing these trained first responders to be reimbursed for providing primary care outreach in sparsely served rural areas. We are also making use of dental hygienists and other mid-level dental
A shrinking rural health care workforce to page 38
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MEDICINE AND THE LAW
Proper notification of payer contract changes Improving and enforcing legislation By Melissa Larson, MBA, and Nancy Haas, JD
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he Min nesota Medica l Group Ma nagement Association (MMGMA) has actively pursued legislative priorities to improve access to health care for its members and clients. Over the past two years, MMGMA has specifically worked to change Minnesota statutes to require proper notification and consent by providers of changes to health plan contract terms, policies and procedures, and fee schedules. Every year health plans may need to change policies and procedures during the term of contracts due to market forces, a desire to streamline or improve
access to plan components, or to accommodate changes of state and federal legislation. The issue however, is that these changes often affect patient care and provider reimbursement. The health plans are not providing adequate notice as required under current law nor are they seeking active and written consent to acknowledge and accept the changes. Proper notice It is critical that policy and financial changes affecting patient care be communicated with sufficient notice to providers not only for purposes of
having a constructive dialogue with the medical directors of the health plans, but also to allow providers adequate time to inform patients of any changes affecting their care. This notice will help allow for improved communication and decision-making on patient care between health plans and providers. It will also allow greater ease in understanding and communication to patients when those changes involve services that will no longer be covered by their health plan or be reimbursed to the provider. When unilateral changes are implemented through passive amendmentsâ&#x20AC;&#x201D;for example an email newsletter with a notice in small print at the bottom changing fee schedulesâ&#x20AC;&#x201D;proper notice is not achieved. When proper notice is not provided it can negatively affect patient care, while simultaneously increasing staff costs associated with submitting appeals and resolving improper
for post-operative pain blocks. This policy change could have a negative impact on patient care if anesthesiologists discontinue administering pain blocks following surgery simply because the health plan no longer pays for it. Anesthesia groups may continue to provide and bill for appropriate services and as a result receive hundreds of claim denials, which lead to hundreds of claim appeals. If the payer has inadequate staffing resources to process the anesthesia appeals it can result in an appeals backlog of many months for all providers. Fortunately, the health plan rescinded part of its anesthesia policy to include post-operative pain blocks for some surgeries but not before the resulting additional cost not only to the health plan and the clinics for administrative time and effort, but also the additional monies that were paid in interest upon settling these claim appeals. The anesthesia providers continue to
Health plans are not providing adequate notice as required under current law.
denied claims; not to mention delayed cash flow for providers and incorrect patient billing. What happens without proper notification? Here are a few examples of issues routinely encountered by physicians and clinic managers. Implementing modifier policies or bundled services that reduce provider payment. For example, a payer unilaterally decided to discontinue paying
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dialogue with the health plan about the appropriateness of post-operative pain blocks for many other surgical procedures and patient populations such as pediatrics. The importance of communication. Due to the various health plan appeals processes, provider groups often have to wait six months or more to address an issue that could have been prevented in the first place if there had been adequate
communication between the health plan and medical leadership in the provider community. This is certainly the case in the anesthesia example just discussed. Two-way communication is vital for providers to collaborate with health plans to ensure that patients receive high quality care. Poor communication can lead to distrust with the health plans, and can result in animosity between parties. In a recent example, a health plan emailed its monthly provider newsletter notifying providers of multiple changes to utilization policies, coverage polices, and clinical guidelines that will become effective Jan. 1, 2017. Providers have no recourse if they disagree with the health plan policies or find that providing services is no longer financially viable. Providers may terminate their network participation when it is time to renew their health plan contract but the effective dates of policy changes do not necessarily coincide with contract renewal dates. The appeals process The administrative efforts necessary to complete the appeals process set forth by the health plans is lengthy. MMGMA has heard from clinics firsthand about the frustration surrounding the requirements placed on providers to see which services and medications are covered by the plans. Clinics and their administrators are forced to follow many trails to see how services are covered for each health plan and even then they must spend valuable time completing the appeals process if claims are denied. One clinic had a drug claim denied as, “investigational” and upon further clarification from the health plan, learned this was in error. Despite the error on behalf of the health plan, the clinic was still required to create and file an appeal and wait for payment. Some clinics have over $100,000 tied up in appeals. The administrative time spent creating, submitting, and following up on such claims is a great cost to clinics and providers and it is not a sustainable process to continue.
What amending the law would mean MMGMA has sought to educate the health plans and legislators about why improper notice adversely impacts providers and ultimately, patients. One concern is the often late release of fee schedules. Providers need adequate time to review the health plans’ proposed fee schedule and providers are contractually obligated to provide adequate notice to the health plans should the provider choose to terminate their contract, which could dis-
communication and thereby better access and procedures for health plans and providers to engage in that provide better outcomes for patients and the overall health care system. MMGMA is actively seeking support and input from its members to help us make our case in the upcoming legislative session. Please send along any examples to add to this conversation to legislative counsel Nancy Haas at nhaas@messerlikramer.com or Payer Relations Chair Melissa Larson at mlarson@ihnhealth.com. MMGMA is
Some clinics have over $100,000 tied up in appeals. rupt patient care. Currently the law requires a 45-day notice of such changes to clinics and providers. Our legislative efforts (see H.F. 1303/S.F. 1175) have centered on additional time requirements —165 days —to help underscore the importance of the notice required under current law and the issues raised as a direct result of not adhering to it. Despite significant dialogue with the health plans about these issues, the health plans continue to take the position that everyone is following the notice but when individual examples occur where plans are not following the notice provision, they request that MMGMA notify them so they can address them on a case-by-case basis.
also interested in hearing from physicians and members who have relationships with legislators and are willing to assist in our advocacy efforts.
Melissa Larson, MBA, is vice president of operations for Integrity Health Network. Her responsibilities include health plan contracting, reimbursement analysis, and she works closely with member clinics to develop operational strategies to succeed in emerging payment models. Melissa has more than 20 years of experience in health care including 10 years in clinic administration. She served as the MMGMA Payer Relations Committee Chairperson and is active on the MMGMA Government Affairs Committee.
Nancy Haas, JD, has been working in
the legislative arena for 20 years. She is the chair of Messerli & Kramer’s Governmental Relations Division and sits on the board of directors. Before joining Messerli & Kramer, Nancy worked in local government, state agencies, and the Legislature, so she has a strong understanding of how government operates. Her work with Messerli & Kramer includes helping clients with issues that come before each of those governmental entities.
Advancing legislation Much work has been done by MMGMA to review the many cases that arise—some of which have been articulated here—and the negative consequences to patients and providers of improper notice. As a result of this work with clinics and providers MMGMA intends to advance legislation during the 2017 legislative session that addresses penalties for lack of proper notice. It is our hope that putting tougher penalties in place to discourage lack of notice can improve NOVEMBER 2016 MINNESOTA PHYSICIAN
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PROFESSIONAL UPDATE: CARDIOLOGY
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efractory VF cardiac arrest is defined as a pulseless arrest with an initial shockable rhythm (ventricular fibrillation or ventricular tachycardia) where the patient does not achieve return of spontaneous circulation (ROSC) despite at least three shocks, epinephrine, and amiodarone. These patients may convert to pulseless electrical activity or asystole during resuscitation efforts, but they are still considered refractory VF cardiac arrest. In the past, only 8 percent of the patients from the Twin Cities with refractory VF arrest survived to hospital discharge with normal or mildly impaired neurological function. But, an emerging protocol in the Twin Cities that blends pre-hospital care from emergency medical service providers and highly specialized, extra-corporeal membrane oxygenation-based hospital care is helping significantly increase the odds of survival.
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ECMO for refractory cardiac arrest A Lazarus act By Demetri Yannopoulos, MD, and Jason Bartos, MD, PhD
Extra-corporeal membrane oxygenation (ECMO) ECMO was first described by Bartlett and Hill in the 1960s. The first successful use of membrane oxygenation for an extended period of time was reported in 1972 by Dr. Robert Bartlett for an adult patient with a ruptured aorta who was maintained for three days. However, the primary patient population for ECMO before that was in pediatrics until recently. ECMO has two primary conformations: 1) V-A ECMO provides cardiopulmonary support similar to
MINNESOTA PHYSICIAN NOVEMBER 2016
the intra-operative support used during cardiac bypass surgery, and 2) veno-venous (V-V) ECMO provides respiratory support necessary for severe cases of acute respiratory distress syndrome. Recent influenza pandemics have increased the use of V-V ECMO for respiratory support. ECMO has traditionally been employed by cardiac surgeons performing arterial cut downs or sternotomies with central cannulation, but ECMO cannulation is increasingly initiated by interventional cardiologists
using percutaneous access in the femoral artery and vein. V-A ECMO removes blood from the venous circulation of a patient, passes it through an oxygenator, and pumps it into the arterial circulation that supports patients in two fundamental ways. First, the pumping function provides flows of up to 5 L/min, though this depends on multiple factors including the size of the catheters that are inserted and the pathophysiology of the specific patient. Second, V-A ECMO provides respiratory support by passing blood through an oxygenator, which removes carbon dioxide and instills oxygen. In this way, patients who have no native cardiac function can receive normal flows of oxygenated blood, which can perfuse the brain, coronary arteries, and all other organ systems while the native heart recovers. New advances The new protocol has two critical components. First, in
the pre-hospital setting, first responders and EMS personnel focus on identifying VF cardiac arrest patients early with plans for rapid mobilization. Initially, EMS will start treatment with defibrillation and medication as they normally would for anyone experiencing cardiac arrest. However, once they reach the point of delivering amiodarone, they prepare the patient for rapid transport to a nearby catheterization laboratory with ongoing mechanical chest compressions, ventilation, and intravenous medications en route. Prior to this protocol, paramedics would continue resuscitation efforts in the field. The second critical aspect of the protocol is the treatment at the hospital. The patient bypasses the ER and is taken immediately to the cardiac catheterization laboratory. In the lab, they are placed on mechanical circulatory support including veno-arterial ext ra- cor porea l membra ne oxygenation (V-A ECMO) within the first five to 10 minutes.
Teams perform a coronary angiogram to determine if the patient has any significant coronary artery disease, which is the most common etiology of refractory VF cardiac arrest, and then address it immediately. After they address the coronary artery disease, care teams perform defibrillation and other medical procedures so the patient can return to spontaneous circulation. At that point, the patient is transferred to the cardiac intensive care unit where they receive therapeutic hypothermia, pressor, and inotropic support, and other treatments as necessary. V-A ECMO is necessary for these patients because of the complete circulatory collapse induced by 30 to 60 minutes of low blood flow and tissue oxygenation during CPR. Even if patients achieve ROSC and maintain their blood pressure without medical augmentation, they often worsen over the first hours and require further support. With ECMO, they are protected from this collapse and
use of inotropes and vasopressors can be minimized to promote systemic recovery.
ECMO is feasible and can provide a significant benefit. Limited data Multiple small observational and registry studies have looked at the use of V-A ECMO in cardiac arrest with mixed results. However, no randomized controlled trials have been performed to address this issue. A registry analysis from Japan published in 2014, called the SAVE-J trial, demonstrated a 12 percent survival rate for patients who received ECMO compared to 1.5 percent survival in the standard resuscitation group. The CHEER trial published from Australia in 2015 demonstrated a 45 percent
rate of survival in patients with out-of-hospital cardiac arrest. Most recently, a study from Germany published in 2016 showed a 31 percent survival rate. Further study and discussion of the care provided after initiation of ECMO is needed to improve the survival statistics. Because of the limited data regarding ECMO in cardiac arrest patients, the guidelines from the American Heart Association have recommended that paramedics treat refractory VF patients in the field until they have ROSC or are declared dead. However, the 2015 American Heart Association guidelines state that insufficient evidence is available to recommend the routine use of ECPR though it may be considered for patients whose injury is likely reversible. In Minnesota, the efforts for VF patients are typically discontinued if ROSC is not achieved after 45 minutes.
ECMO to page 36
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ECMO from page 35
Partnering with EMS At the University of Minnesota Medical Center where we practice this new protocol with help from North Memorial EMS, Ridgeview Medical Center EMS, and St. Paul Fire and Rescue, we recently published our research in the Journal of the American Heart Association that describes the success of this new approach. Patients were included in our research if they were age 18â&#x20AC;&#x201C;75 and suffering an out-of-hospital cardiac arrest where the first presenting rhythm was shockable. Paramedics from the three emergency medical services systems from around the Twin Cities initiated transport to the university if at least three shocks and amiodarone were ineffective and the expected transport time would be less than 30 minutes. Mechanical chest compressions were required during transport.
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Survival rates We used the emergent advanced perfusion strategies like ECMO, followed by coronary angiography, and PCI when appropriate. Over the first three months of the protocol, 27 patients were transported with ongoing mechanical CPR. Of these, 18 patients met the inclusion and exclusion criteria and ECMO was placed in 83 percent of these patients. Our initial results demonstrated that we can improve survival to at least 50 percent compared to the 8 percent survival rate for this population under the traditional protocol. Seventy-eight percent of patients had significant coronary artery disease with a high degree of complexity and 67 percent received percutaneous coronary intervention (PCI). Seventy-eight percent of patients survived to hospital admission and 55 percent survived to hospital discharge with 50 percent achieving good neurologic function. No patients experienced ECMO-related complications during this study. Ten months
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after the start of the protocol more than 50 patients have been treated with this approach and for patients that meet the inclusion criteria, survival remained greater than 50 percent.
We can improve survival to at least 50 percent compared to the 8 percent. Conclusion Our results so far demonstrate that emergent ECMO is feasible and can provide a significant benefit to this severely ill patient population. The ability to place ECMO emergently is possible due to the rapid transport directly to the catheterization laboratory where interventional cardiologists are available to perform percutaneous placement. The available fluoroscopy and ultrasound provides visualization of the arterial and venous access and cannula position. These ECMO devices, along
with advances in portable chest compression technology such as the LUCAS device, have contributed to this newfound success. Perhaps most importantly, these promising outcomes would not be possible without the wellcoordinated efforts between pre-hospital EMS experts and in-hospital surgical teams. The collaboration is drastically improving survival among a severely ill patient population that has seen little improvement over the past three decades. With continued collaboration, itâ&#x20AC;&#x2122;s possible to achieve even greater successes. Demetri Yannopoulos, MD, is an interventional cardiologist and professor of medicine at the University of Minnesota. He holds the Robert Eddy Endowed Chair for Resuscitation Medicine and is the medical director of the Minnesota Resuscitation Consortium. Jason Bartos, MD, PhD, is a board-cer-
tified general cardiologist and critical care physician currently training in interventional cardiology at the University of Minnesota.
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A shrinking rural health care workforce from page 31
providers to help meet a critical need for dental care in rural communities. Mobile medicine and telemedicine are helping extend expert medical resources to serve rural patients. Legislators recently passed the Minnesota Telemedicine Act, requiring equal reimbursement for medical services delivered via telemedicine as for the same services delivered face-to-face. This is particularly helpful in extending mental health services to rural areas of our state. Technology is also helping us remotely monitor the health and activities of daily living (ADLs) for isolated rural residents, helping catch problems before they become emergencies. Just as the challenges of rural health and health care var y f rom community to community, so do the solutions. Community-based volunteer
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programs, often sponsored by faith communities, are helping fill gaps in rural emergency and non-emergency transportation, getting people to medical
that reaching out to rural high school students is an important strategy because here we find young people with a heart and appreciation for the rural
Many small town critical access hospitals are in jeopardy of closing.
appointments, the pharmacy and grocery shopping, or delivering a nutritious meal with a friendly face. Conclusion Ultimately, effectively addressing the critical need for rural health care providers will require more comprehensive, c om mu n it y- b a s e d, c a r e e roriented approaches. Think of it not so much as a supply and demand equation as a rural community economic development challenge. We know
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lifestyle. But loan forgiveness programs, short-term grants, alternative practitioners, technology, mobile medicine, and even community volunteers are not enough. To paraphrase an old African proverb, “It takes a village to raise (and keep) a rural health care provider.” He a lt h c a r e pr ofe ssion s students and new Americans considering long-term rural practice need to see a sustainable career path for themselves and their families. This includes reasonable pay, support with
rotations to avoid burnout, good jobs for spouses, adequate housing, strong schools and day care options for their children, and other community amenities contributing to quality of life. When people question the need to get involved in strengthening rural health and health care, I ask an important question: “Are jobs and economic opportunity important to your community?” The answer, invariably, is “Yes.” I then ask, “Is it easier to attract jobs and economic opportunity with good health care in your community, or without?” The answer is obvious. The overall health and well-being of all our rural communities depends on access to adequate and affordable health care. That makes the challenges of strengthening rural health everyone’s business.
Steve Gottwalt is executive director
of the Minnesota Rural Health Association.
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Rural medicine and VBR from page 27
true in joining forces to participate in a shared savings program. Without a binding force in which each has skin in the game, it would be challenging for these practices to collaborate. Seeing beyond the walls Traditionally we have not had much control over the cost of care once the patient is outside of our office. One of the advantages of joining a Medicare Shared Savings accountable care organization is that you can get data from CMS that allows you to see the total cost of your patients; where they are going, who is treating them, and the cost of those treatments. Though there is a several month lag before getting this information, it does provide information that is actionable. For example, in our ACOs, this data enables us to see which ophthalmologists are using FDA-approved medications for wet macular
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degeneration at approximately $1,800 an injection or an equally effective generic at about $50 an injection. This data has also allowed us to identify a specialist who was ordering an order of magnitude more labs than others in his specialty. He was approached
at the start of the weekend and then become short of breath. As a result of this knowledge, the physician enrolled this patient in a care management program. Now each Friday the care management nurse calls the patient to check in and see how he is doing. Additionally,
Our old method of paying for services regardless of outcome is unsustainable.
and chose to change his ways instead of losing referrals. This data also allows providers to see which patients are frequenting the emergency room. In one example, a provider noticed that his patient, who had chronic obstructive pulmonary disease and mild anxiety, was frequenting the emergency room almost every weekend. The patient would get anxious
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since a shot of Solu-Medrol seems to work each time he went to the emergency room, the patient now knows that the hospital has a standing order to give him a shot when he needs it without incurring emergency department costs. Without this data feed, this patient would continue to frequent the emergency room and risk hospital admission.
What’s next? The final rule for MACRA is not yet written. We can expect to see it sometime this fall. There are some exemptions in the proposed rule for the smallest of practices but many say it does not go far enough. Whatever the rule includes, our old method of paying for services regardless of outcome is unsustainable—it has led to an uncoordinated series of services that can lead to expensive care with poor outcomes. Value-based payment is here to stay and we will need to adapt if we are to survive and thrive. Take the time to study your options. It will serve you well if you do. Paul Kleeberg, MD, is a family physician
and has practiced rural family medicine. He is a medical director for Aledade, Inc., an organization providing a new model of primary care that partners with physicians to build and lead accountable care organizations (ACOs) that allow these doctors to stay independent, practice medicine like they’ve always wanted to, and thrive financially by keeping people healthy.
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Political divisiveness in health care from page 17
Eliminating financial barriers to care (copays, deductibles, etc.) resonates with liberal values of caring and fairness. Again applying Haidt’s data, this part of the discussion could also resonate with conservative values of sanctity (no one’s health should be compromised because they can’t pay for care) and loyalty (every American should be able to get health care). Stabilizing the nation’s costs resonates with the conservative values of sanctity (we should be good stewards of resources) and loyalty (draining business resources through excessive insurance overhead weakens America). It also resonates with the liberal values of caring (wasting health care money undermines other important social programs) and fairness.
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No matter where one falls on the political spectrum, most are offended by systems that restrict their choice of physicians and other providers. Losing control over these choices is a clear violation of sanctity, and a health-care system wherein insurance com-
demonizing and alienating, each other. The importance of respect Anyone interested in developing diplomatic skills for dealing with colleagues who seem to have intractable and negative opinions should begin by better
We need to relearn how to respect those with whom we disagree.
panies contradict physicians’ recommendations is a violation of the authority value. When either side believes it alone holds the “moral high ground,” it has already lost the argument. From the Great Compromise to Hatch-Waxman and beyond, our greatest social advances have come from listening to and respecting, not
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understanding the moral and psychic underpinnings driving those opinions. Embrace the dialogue by granting the respect and dignity your colleagues deserve. One of the best ways to have them respect you is to show colleagues the respect you think your opinions deserve. The fabric of democracy has endured for centuries, but never
without challenges and struggles. Today, however, we’re at a high-water mark of disparate points of view, and we’re finding it increasingly difficult to listen to and understand each other. More important than the fleeting issues of electoral politics, more important than the issues related to reforming our national health insurance strategy, the fabric of our democracy must be preserved and strengthened. Only by understanding and regaining the respect for— and the respect of—those with whom we disagree can we move forward toward solving our growing national health care problem.
Ed Weisbart, MD, is a family physician in St. Louis, MO. He volunteers in a variety of safety net clinics, and chairs the Missouri chapter of Physicians for a National Health Program.
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