Mn Physician Apr 2016

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A breakthrough in heart failure treatment to page 22

The Minnesota Tri-Regulator Collaborative to page 16

Vo lum e X X X, N o. 1A p r i l 2016

Heart failure affects over 5 million adults in the United States and its prevalence is predicted to increase as the popu-

lation of America ages. Despite detailed guide-lines for the management of heart failure with reduced ejection fraction (HFrEF), it remains a leading cause of cardiovascular morbidity and mortality worldwide. Furthermore, the evi-dence-based management of heart failure with preserved ejection fraction (HFpEF), which comprises approximately half of all cases of heart failure, remains elusive.

Heart failure management has evolved slowly over the past several decades, although approval of new medications remains sparse. The use of angiotensin-converting enzyme (ACE) inhibitors and beta blockers, demonstrat-ed to have mortality benefit in HFrEF and the mainstay of heart failure therapy today, has remained largely unchanged over the past 20 years (Hunt et al., 2005). With the increasing understanding and importance of the renin angiotensin aldosterone pathway, the use of mineralocorticoid receptor antagonists has

A breakthrough in heart failure

treatmentAngiotensin Receptor Neprilysin Inhibition

By Siu-Hin Wan, MD, and Horng H. Chen, MD, BCh

The Minnesota Tri-Regulator Collaborative

Protecting patient safety

By Ruth Martinez, MA; Shirley A. Brekken, MS, RN; and Cody Wiberg, PharmD, MS, RPh

Medication PAMade Easy

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APRIL 2016 MINNESOTA PHYSICIAN 3

APRIL 2016 • VOLUME XXX, NUMBER 1

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PUBLISHER Mike Starnes | [email protected]

EDITOR Lisa McGowan | [email protected]

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The KAMRA corneal inlay 20By Richard L. Lindstrom, MD, and David R. Hardten, MD, FACS

2016 COMMUNITY 26 CAREGIVERS Making a difference in Minnesota and the world

By Lisa McGowan

CAPSULES 10

MEDICUS 13

INTERVIEW 14

ADDICTION MEDICINE 18Addiction treatment for physicians

By Marc Myer, MD

WOMEN’S HEALTH 24Doula-assisted birth

By Katy B. Kozhimannil, PhD, MPA; Rachel R. Hardeman, PhD, MPH; and Jennifer Almanza, BAN, RN, PHN

ELECTRONIC HEALTH 34 RECORDSStreamlining electronic claims submissions

By Dipesh Patel and Courtney Willis

The Minnesota Tri-Regulator 1 Collaborative Protecting patient safetyBy Ruth Martinez, MA; Shirley A. Brekken, MS, RN; and Cody Wiberg, PharmD, MS, RPh

A breakthrough in heart 1 failure treatment Angiotensin Receptor Neprilysin InhibitionBy Siu-Hin Wan, MD, and Horng H. Chen, MD, BCh

World-class cancer care

John Lee, MD, FACS

Sanford Health

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Value - Based Purchasing:

A new way to pay for health care

Background and Focus: As initiatives driven by federal health care reform move forward, the term “Value-Based Purchasing” (VBP) is being applied to a wide spectrum of issues. But what does this mean? CMS is developing measurements, well over 150 to date, to define what “value” means in health care. It is proposed that these metrics will be used to create incentives that pay more for better care in every element of health care delivery. Hospitals, physician practices, home care, and long-term care will all be reimbursed by an emerging new math.

Objectives: We will explore the motivations behind this changing approach to purchasing health care. We will examine what is being measured and what value really means. We will discuss the arguments that claim VBP is a bad idea and those that believe it is the best solution. We will discuss how a collaborative, transpar-ent system, that integrates care teams, health information tech-nology and improved reimbursement methods will help achieve increased access to high-quality, cost-effective care for patients.

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Thursday, November 3, 2016 • 1:00-4:00 PMSymphony Ballroom, Downtown Minneapolis Hilton and Towers

FORTY-SIXTH SESSION

MINNESOTA HEALTH CARE ROUNDTABLE

038393_eldhcp_PP-DG-US-0393_ja_mp_fa.indd 1 2/25/16 2:06 PM

4 MINNESOTA PHYSICIAN APRIL 2016

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

It clicked when my doctor and I discussed Trulicity®1,2

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 the following page and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.

Unbeaten A1C reduction* across 6 head-to-head trials1,3

Mea

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• 26-week, randomized, open-label comparator 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 of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met

• 104-week, randomized, placebo-controlled, 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 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

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

• 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

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

• 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)

• Starting dose of Lantus was 10 units daily. Lantus titration was based on self-measured fasting plasma glucose utilizing an algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint. Mean daily dose of 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

Data represent least-squares mean ± standard error.

A1C reduction at week 52 vs Lantus1-4

Mea

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)

0

-0.4

-0.8

-1.2

-1.6

-0.2

-0.6

-1.0

-1.4

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

-0.8-0.6

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

-1.1


Add-on to metformin(52 weeks)

Compared to Januvia®1,5,6

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

Compared to Byetta®1,7

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

Compared to Lantus®1,8-10

Add-on to metformin (26 weeks)

Compared to Victoza®3

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






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

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

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

0.0

-0.4

-0.8

-1.2

-1.6

-1.8

-0.2

-0.6

-1.0

-1.4

A1C reduction from baseline


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

Mea

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-1.42-1.36

-1.10

-0.87

-0.39

-1.51-1.30

-0.99-1.08

-0.76-0.63

-0.46

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

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.

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

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



Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORSIn 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.

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 insuffi cient 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 orthyroid 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, discontinueTrulicity promptly. Do not restart if pancreatitis is confi rmed. Consider other antidiabetic therapies in patients with a historyof 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 doseof the sulfonylurea or insulin to reduce the risk of hypoglycemia.

Hypersensitivity Reactions: Systemic reactions were observedin 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, therehave 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 initiatingor 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, andis 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.

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

diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%).

Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications.Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.

Pregnancy: There are no adequate and well-controlled studiesof Trulicity in pregnant women. Use only if potential benefi t 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.

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.

References1. 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.

PP-DG-US-0393 01/2016 ©Lilly USA, LLC 2016. All rights reserved.



Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75 PRINTER VERSION 1 OF 2

TrulicityTM (dulaglutide) DG HCP BS 20APR2015 TrulicityTM (dulaglutide) DG HCP BS 20APR2015

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 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.

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

Limitations of Use:

Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease. 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

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

insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting. Hypersensitivity Reactions: 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

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



Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75 PRINTER VERSION 2 OF 2

TrulicityTM (dulaglutide) DG HCP BS 20APR2015 TrulicityTM (dulaglutide) DG HCP BS 20APR2015

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%) Trulicity-treated 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 placebo-treated 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%) Trulicity-treated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2).

No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed. There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored. Gastroparesis: Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with pre-existing gastroparesis.

OVERDOSAGE

Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (eg, nausea, vomiting) and non-severe hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms.

PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide

• Inform patients that Trulicity causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician. • Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Trulicity promptly, and to contact their physician, if persistent severe abdominal pain occurs. • The risk of hypoglycemia may be increased when Trulicity is used in combination with a medicine that can cause hypoglycemia, such as a sulfonylurea or insulin. Review and reinforce instructions for hypoglycemia management when initiating Trulicity therapy, particularly when concomitantly administered with a sulfonylurea or insulin. • Patients treated with Trulicity should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with Trulicity of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs. • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of 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, USAUS 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



CAPSULES

Health Care Spending Predicted to Double by 2023Health care spending in Minne-sota increased 3.1 percent from 2012 to 2013, reaching $40.9 billion, according to a report from the Minnesota Department of Health (MDH). The growth rate is the fourth lowest recorded in Minnesota since MDH began tracking the trend in 1994 and below the national average of 3.8 percent for 2013. However, it is nearly double the growth rate of 1.7 percent in 2010 and 2011, the two years with the lowest increas-es ever recorded.

“It is good news that Minne-sota’s health care spending grew more slowly than that of the na-tion as a whole in 2013,” said Ed Ehlinger, MD, Minnesota com-missioner of health. “However, we cannot afford to treat our way to full health. We will face signifi-cant challenges related to health care costs unless we sharpen our focus on preventing costly chron-ic diseases.”

Minnesota’s per capita spend-ing on health care was $7,552, much less than the national

average of $8,713. Health care spending accounted for 13.3 per-cent of the Minnesota economy in 2013, compared to 16.5 percent of the total U.S. economy.

The report shows that growth in spending between 2011 and 2013 was primarily driven by in-creasing costs for outpatient, pro-fessional services, and pharmacy spending. Changes in service mix and volume of health care ser-vices played a smaller role.

“Growth in medical services’ prices has been the main culprit in both Minnesota and national spending trends as well,” said Stefan Gildemeister, state health economist at MDH. “We expect the introduction of new phar-maceutical therapies with high treatment costs, layered on top of medical inflation in other sectors, to further fuel spending growth in the upcoming years.”

The report includes future projections that estimate state health care spending will increase 7.8 percent each year and will double by 2023, reaching $85 bil-lion, and that almost 20 percent of the economy will be attribut-able to health care spending.

“This level of growth will be difficult to sustain for Minneso-ta,” the report said. “It will place

substantial, increased pressure on the opportunities of individu-als, businesses, and governments, thereby constraining investments in priority areas outside of health care. This will likely require discussion and action by policy-makers and other stakeholders to ensure that limited health care dollars can best be spent in the most efficient, effective way.”

The largest drivers of future spending growth include price pressure from pharmaceuticals and demographic shifts that result in more older Minnesotans living with complex chronic diseases.

HHS Awards $94 Million to Health Centers to Address Opioid AbuseThe U.S. Department of Health and Human Services (HHS) has awarded $325,000 through the Health Resources and Services Administration (HRSA) to the Regents of the University of Min-nesota to improve and expand delivery of substance abuse ser-vices, especially for opioid use, at the health center.

On March 10, the Senate passed a measure aimed at fund-ing drug abuse treatment and prevention services. Announced on March 11, this award is part of $94 million in Affordable Care Act funding awarded to 271 health centers in the U.S., the District of Columbia, and Puerto Rico.

HHS estimates that the num-ber of unintentional overdose deaths from prescription pain medications nearly quadrupled from 1999 to 2013. Heroin deaths rose 39 percent from 2012 to 2013.

“The opioid epidemic is one of the most pressing public health issues in the United States today,” said Sylvia Burwell, U.S. secretary of health and human services. “Expanding access to medication-assisted treatment and integrating these services in health centers bolsters nation-wide efforts to curb opioid misuse and abuse, supports approximate-ly 124,000 new patients access-ing substance use treatment for recovery, and helps save lives.”

The funds will be used to increase the number of patients screened for substance use disorders and connect them to treatment; increase the number of pain patients with access to medication-assisted treatment


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for opioid use and other sub-stance use disorder treatment; and provide training and educa-tional resources to help health professionals make informed prescribing decisions. Nationally, the funds are expected to help awardees hire about 800 provid-ers to treat the estimated 124,000 new patients.

The whole-patient approach to treatment through medication, counseling, and behavioral ther-apies, has been shown to be the most successful in treating opioid use disorders. More than 1.3 million people, including those in need of substance abuse services, received behavioral health services at health centers—a 75 percent increase since 2008. This new funding will build on the previous investments in health centers with a focus on improving and expand-ing treatment of opioid use disor-ders in underserved populations.

New Fetal Care Center Opens in MinneapolisChildren’s Hospitals and Clinics of Minnesota and Allina Health opened a new fetal care center in Minneapolis on March 14.

The new 6,700-square-foot clinic is named the Michael and Ann Ciresi Midwest Fetal Care Center in honor of a $1 million gift from Minnesota attorney and past chair of the Children’s Foundation, Mike Ciresi, and his wife Ann. It is located within The Mother Baby Center in Minneap-olis and shares space with Allina Health-operated Minnesota Peri-natal Physicians. Construction began in August 2015.

The center has been providing diagnosis and treatment services for congenital conditions and abnormalities in unborn infants during high risk pregnancies since 2008, when it was formally established as a collaboration between Children’s Hospitals and Clinics of Minnesota; Pediatric Surgical Associates; and Allina Health’s Abbott Northwestern Hospital and Minnesota Perinatal Physicians, and other consulting subspecialties. The $1 million gift and new center will bring technology upgrades and new specialists, such as Joseph Lille-gard, MD, PhD, who was hired as research director and pediat-ric surgeon in July 2015 to help advance the launch of the center’s open fetal surgery program.

Diabetes Prevention Program Eligible for Medicare CoverageThe Department of Health and Human Services has announced that the National Diabetes Pre-vention Program will be eligible for Medicare coverage. It is the first preventive health program to become eligible for expanded coverage under Medicare since the Affordable Care Act went into effect six years ago.

“This program has been shown to reduce health care costs and help prevent diabetes, and is one that Medicare, employers, and private insurers can use to help 86 million Americans live healthier,” said Sylvia Burwell, U.S. secretary of Health and Human Services. “The Affordable Care Act gave Medicare the tools to support this groundbreaking effort and to expand this program more broadly. Today’s announce-ment is a milestone for prevention and America’s health.”

The Centers for Medicare and Medicaid Services awarded the National Council of Young Men’s Christian Associations of the United States of America (Y-USA)

more than $11.8 million to enroll eligible Medicare beneficiaries at high risk for diabetes in the prevention program to decrease their risk of health complications. The goal of the program was to improve participants’ health and reduce each participant’s weight by 5 percent, enough to substan-tially reduce the risk of develop-ing diabetes in the future. One of the 17 YMCA locations that participated in the pilot program was the YMCA of the Greater Twin Cities.

More than 80 percent of participants attended at least four weekly sessions. Results from the pilot program show that the average weight loss was 4.73 percent of body weight for those who attended at least four weekly sessions and 5.17 percent for those that attended at least nine. Medi-care saved an estimated $2,650 for each person who enrolled in the program over the 15-month pilot period. The savings added up to more than the cost of the program.

CMS will introduce new regulations to expand coverage of the National Diabetes Prevention Program later this year.

Capsules to page 12


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Nation’s Largest Study on Brain Trauma Launches in MinnesotaAbbott Laboratories, Hennepin County Medical Center (HCMC), and the University of Minnesota are collaborating to conduct the nation’s largest study on concus-sions and traumatic brain injury.

Researchers hope to develop a new standard approach to classify brain injuries and provide more information to doctors to help guide treatment decisions. Currently, the standard practice for assessing brain trauma includes testing a patient’s ability to speak, follow directions, and move eyes and limbs, as well as a CT or MRI scan if deemed necessary. In the new study, researchers will use multiple evaluation tools, including eye tracking, blood-based biomarkers, imaging, and cognitive measures to gain more information.

“Imaging tells us what the brain looks like, eye tracking tells us how well it’s working, and blood-based biomarkers can tell us the nature of the damage,” said Thomas Bergman, MD, co-investigator of the study and chief of neurosurgery at HCMC. “When we put all of this information together, we will have a better understanding about brain injury that will help us treat patients now and in the future.”

Researchers plan to screen 9,000 trauma patients and enroll a minimum of 1,000 of them in the study. Participants will range from children to the elderly and include people who are conscious as well as people in comas. The study will follow up with them for up to one year.

Uzma Samadani, MD, PhD, Rockswold Kaplan Endowed Chair for TBI Research at HCMC, associate professor at the University of Minnesota, and one of the lead investigators of the study, has conducted research in the past that has suggested eye tracking may detect injuries in the brain that may not be visible in imaging.

“Data have shown a connection between brain injury and abnormal eye movements,” said Samadani. “With new high-resolution cameras, we can detect subtle differences in movement much more easily and objectively than in the past.”

Abbott Laboratories researchers are developing a test to detect specific proteins in the blood that are associated with brain injury. It will be analyzed on Abbott’s i-STAT, a handheld, portable device used at a patient’s side to deliver blood test results right away. And funds from the Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant Program will be used for MRI imaging to look for finer structural issues in patients that may not be visible in CT scans.

“We know that there are different types of brain damage that can occur after trauma, whether it’s a mild concussion or a severe injury,” said Samadani. “Our goal with this study is to combine multiple assessment techniques to quickly assess the severity of brain injuries

and enable clinicians to provide appropriate treatments.”

Fairview Leaves Minnesota Hospital AssociationFairview Health Services has dropped out of the Minnesota Hospital Association (MHA). Fairview is the fourth-largest health care provider in Minnesota with about $3.6 billion in annual revenue and six hospitals.

“We are disappointed. They were a very active member and we hope they return in 2017,” said Wendy Burt, vice president of communications and public relations at MHA. Fairview has not made a statement regarding the decision.

Fairview is currently in the process of merging with the University of Minnesota Physicians and has no permanent CEO. The health system told MHA it will reconsider joining again in 2017.

Capsules from page 11


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Aaron Folsom, MD, MPH, cardiovascular epi-demiologist and professor of epidemiology and community health at the University of Minne-sota School of Public Health, has received the Joseph Stokes III Award in Preventive Cardi-ology from the American Society for Preventive Cardiology in recognition of his significant con-tributions in the field of cardiovascular preven-tion. Folsom has more than 35 years experience in exploring the causes of, and ways to pre-vent, cardiovascular disease. He has served as principal investigator of several major studies, authored or coau-thored more than 850 publications, and spent more than 20 years directing a Minnesota training grant in cardiovascular disease epi-demiology and prevention research. He earned his medical degree at Ohio State University and his masters in public health from the University of Michigan.

Deb Thorp, MD, obstetrician/gynecologist at Park Nicollet, has received the 2016 Pete and Weesie Hollis Community Service Award in recognition of her outstanding work with the Somali and LGBT communities in Minnesota. Thorp created a transgender services program at the clinic in Minneapolis and conducts gender competency training for providers. She is the past president of Isuroon, a nonprofit organi-zation working to promote the well-being and

empowerment of Somali women in Minnesota and beyond. Thorp earned her medical degree at the University of Minnesota Medical School. She completed an internship at Cook County Hospital and a residency at the University of Minnesota. Her special interests include minimally invasive surgery, lesbian and transgender health care, adolescent gynecology, general obstetrics and gynecology, and Somali women’s health care.

Devanshu Kansara, MD, orthopedic surgeon and sports medicine specialist, has joined the Monticello Clinic. Previously, Kansara prac-ticed at TRIA Orthopaedic Center and served as an associate team physician for the Minnesota Timberwolves. He specializes in arthroscopic surgery, osteoarthritis, and knee replacement arthroplasty, and speaks Gujarati. Kansara earned his medical degree at the University of Michigan Medical School. He completed an orthopedic surgery residency at Wayne State University in Detroit and a sports medicine fellowship at TRIA Orthopaedic Center.

Kristin Janke, PhD, director of the Wulling Center for Innovation and Scholarship in Phar-macy Education and professor in the Depart-ment of Pharmaceutical Care & Health Systems at the University of Minnesota, has received the 2016 National Alliance of State Pharmacy Associations (NASPA) Excellence in Innovation Award for outstanding contributions to the pro-fession of pharmacy. The award recognizes qual-ified pharmacists who have improved patient

care and/or advanced the pharmacy profession by making signif-icant innovations in their practice, methods, or services. Janke has held various administrative appointments at the University of Minnesota College of Pharmacy, including assistant dean for edu-cational development and associate dean for assessment and cur-ricular development. She earned her doctor of philosophy in social and administrative pharmacy from the University of Minnesota.

MEDICUS

Deb Thorp, MD

Aaron Folsom, MD, MPH

Kristin Janke, PhD

Devanshu Kansara, MD

Osmo Vänskä /// Music Director

minnesotaorchestra.org612.371.5656 / Orchestra Hall

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CIRQUE DE LA SYMPHONIE WITH THE MINNESOTA ORCHESTRA Sat May 21 8pm / Sun May 22 2pm Sarah Hicks, conductor

Watch the Orchestra perform while all around them (and flying over their heads!) the internationally acclaimed artists of Cirque de la Symphonie bring the Big Top to Orchestra Hall.

ERIN KEEFE PLAYS BRAHMS Fri May 27 & Sat May 28 8pm Osmo Vänskä, conductor / Erin Keefe, violin

Hear one of the most beloved works for violin—Brahms’ Violin Concerto—performed by concertmaster Erin Keefe.

Thu May 26 8pm / SYMPHONY IN 60Enjoy this one-hour performance of this week’s concert followed by post-concert cocktails onstage with the musicians. Tickets $29 / $20 for patrons under the age of 40.

VÄNSKÄ CONDUCTS MAHLER’S FIFTHThu Jun 9 11am / Fri Jun 10 & Sat Jun 11 8pmOsmo Vänskä, conductor / Christian Tetzlaff, violin

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World-class cancer care

John Lee, MD, FACS

Sanford Health

Dr. Lee is lead head and neck specialist surgeon at Sanford Health in Sioux Falls, SD. He is responsible for the development of the management, research, and clinical arm for treatment of head and neck cancer. In addition to his clinical practice, he leads an internationally recognized research team that has introduced three new com-pounds to clinical trial. His goal is to offer the best treatment in the world and then make it even better.

Dr. Lee received his medical degree from the University of Minnesota School of Medicine, and completed his residency at the University of Iowa, where he also finished a fellowship and stayed on after being promoted to associate professor. He joined Sanford Health in 2008.

Dr. Lee is active nationally in the American Head and Neck Society and sits on the National Cancer Institute’s head and neck immune therapy committee. He has been awarded Sanford Physician of the Year.

Please tell us about some of the specific conditions that are treated by head and neck cancer physicians.

Head and neck cancer surgeons are specialty phy-sicians focused on treating benign and malignant masses above the collarbone and outside the brain. These include thyroid cancer, throat cancer, mouth cancer, salivary gland cancers, and skin cancers. Head and neck cancer surgeons have additional training to surgically resect masses and reconstruct the head and neck defects created by the resection. Head and neck surgeons are board-certified fellow-ship-trained and have extensive experience with complex surgeries including skull-based surgery, free flap tissue reconstruction, robotic surgery, and microvascular surgery.

How do head and neck cancer physicians collaborate with dentists?

The dental community is the first line of defense in early detection of oral cancers. Dentists complete screenings for oral cancers and neck masses during each patient’s dental exam. They look for lumps or white or red patches in the mouth or on the tongue. We work closely with dental offices and offer imme-diate consultations for any patient with a concern-ing lesion or lump. We also work with dentists to get optimal tooth care during treatment of head and neck cancer with radiation and chemotherapy.

Please talk about transoral robotic surgery (TORS).

TORS is a technique that uses a robot with arms and a video scope to remove tumors from the back of the throat. It is a useful technique that provides improved swallow outcomes compared to older techniques that required much more extensive sur-gery to remove these cancers.

Sanford Health is a center for excellence in treating head and neck cancer. What can you tell us about this?

About eight years ago, we formed a team of physi-cians and ancillary staff aimed at providing world-class standard of care and novel treatment options in the form of clinical trials for all our cancer patients. This currently involves a large multidis-ciplinary team of 20 physicians and ancillary staff meeting each week to discuss head and neck cancer patients. We take a strong team approach and work together to provide each head and neck cancer patient an extensive review of their specific case. Based on input from all team members, we tailor individual treatment, follow up, surveillance, and survivorship plans. Like any team that works well together, the sum of the parts is greater than indi-vidual input. This method has led to outstanding survival outcomes and improved quality of life for

our patients. Our entire team is committed to the core principles of a world-class cancer program: quick access to specialty care, high quality patient experience, continuous communication, and lead-ing outcomes for survival and quality of life. Even with the best standard of care in head and neck cancer, some patients need additional treatment. As part of the National Cancer Institute’s Community Oncology Research Program (NCORP), we are one of only 34 community sites in the United States providing National Cancer Institute clinical trials for head and neck cancers. With groundbreaking research in head and neck cancers, our team of researchers and physician scientists are able to offer our patients access to unique clinical trials available at Sanford Health. We provide the most advanced care and treatment that today’s medical research can offer.

The occurrence of head and neck cancer has increased in the past few years. Why is this?

According to the American Society of Clinical Oncology, head and neck cancer accounts for about 3 percent of all cancers in the U.S. Oral and throat cancers related to smoking have decreased in the last 10 years but cancers related to human papillo-mavirus (HPV) have increased 300 percent. This is primarily in males ages 45 to 65 who do not smoke. The exact cause of this is still under investigation, but some risk factors point to increased sexual part-ners and sexual practices. Thyroid cancer has also increased although not as dramatically. This is in part due to our ability to detect this type of cancer.

What are some of the most promising clinical trials available to head and neck cancer patients?

The most promising clinical trials currently involve using our body’s immune system to attack and kill cancer cells. These unique therapies are known as immunotherapy. It is a quickly developing field of cancer treatment with an unprecedented ability to deliver safer and possibly more effective treat-ments. They have the potential to offer fewer side effects and long-term responses in some patients. These are being offered currently as later stage tri-als for head and neck cancer. We have several trials open for most cancers of the head and neck region.

What specifically has allowed for the recent increase in head and neck cancer survival rates?

Most of the increased survival rates in our pa-tients come from the improved response rates of HPV-related cancers in the oropharynx (throat). In many centers, including ours, we see long-term survival in the high 90 percent range at two and four years post diagnosis. HPV-positive throat cancer has responded very well to almost all forms

INTERVIEW


of therapy, including surgery, external beam radiation, and chemotherapy. New treatment protocols have been developed that greatly improve treatment, survival, and side effects for these patients. If these cancers are detected early, the use of robotic surgery followed by a course of radiation treatment has shown increased survival and quality-of-life outcomes.

What are some of the biggest challenges facing head and neck cancer treatment today?

The biggest challenge right now is to bring new and safer treatment op-tions to this field that do not leave our patients with long-term dysfunction of swallow and speech. We need to offer therapies that maintain high cure rates but are less toxic for our patients. The ability to speak and eat are such an important part of our daily lives and therapies that main-tain these functions need to be tested and brought to clinic for our patients.

What are some of the biggest scientific advances in the field of head and neck cancer?

Historically, most cancer treatments were designed for the average cancer patient. As a result of this one-size-fits-all approach,

treatments are very successful for some patients and ineffective for others. Personal-ized medicine allows physicians and re-searchers to better understand the complex makeup of a tumor and then better predict which treatments will be most effective and offer potentially fewer side effects. Cur-rently, two scientific advances will allow

us to better understand how to treat these cancers. First, the ease of genomic testing allows us to examine the DNA and RNA of cancers and will soon help us determine which cancers will respond to a particular therapy. Second, these same tests can be used to better utilize immune therapy to give patients an option to let their body help fight the cancer. Decades ago, understanding how bacteria grew led to the advent of anti-biotics to clear infection. Resistance of bac-teria is now better understood and we can treat with an antibiotic to which a bacteria is sensitive. In the same manner, genomic

testing allows us to quickly determine if a cancerous tumor contains certain genetic markers. Those results may then be used to customize treatment options and employ targeted therapies specific to a patient’s tumor. The challenge is to gather this data and get it tested safely in patients.

What does the future hold for diagnosing and treating head and neck cancer?

The future of head and neck cancer care will see improved therapy op-tions and multidisciplinary care teams at the specialist level. Therapy options will include a combination of ap-proaches like genetic testing, less in-

vasive surgery, radiation, and immune thera-pies to treat cancers based on changes to the genetic code and expression of cancer genes. In the past, we based a treatment plan on the tissue from which cancer originated. In the future, a treatment plan will be based on unique changes that have occurred in each individual’s cancer cells. Those cellular changes will be reviewed by a multispecialty team of doctors across the nation who can recommend customized treatment options, including targeted therapies, to each patient based on their specific results.

We provide the most advanced care and treatment that today’s

medical research can offer.


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Together, the Minnesota Boards of Medical Practice, Nursing, and Pharmacy reg-ulate the largest population of licensed health care practi-tioners in Minnesota (see Table 1). The Board of Medi-cal Practice licenses or registers several types of health care practitioners in addition to physicians: physician assistants, respi-ratory therapists, athletic trainers, acupuncturists, naturopathic doctors, and traditional midwives. The Board of Nursing regu-lates advanced practice, licensed practical, and registered nurses and cer-tifies public health nurses. The Board of Pharmacy licenses individual phar-macists and pharmacy technicians, and, unique-ly, also licenses pharmacies, drug manufacturers, and wholesalers.

Effective interprofessional collaboration among physi-cians, nurses, and pharmacists enhances patient safety and well-being, and collaboration among state-based medical, nursing, and pharmacy regula-tors can have a similar effect on public protection.

The Minnesota Boards of Medical Practice, Nursing, and Pharmacy have collabo-rated for many years on health

policy issues of mutual concern. Although each Board is auton-omous and enforces its own practice act, they are subject to common laws and operate with-in a common statutory frame-work. Collaboration has a basis in the Boards’ mutual values, common purpose, and statutory

obligation to protect the public’s safety and well-being.

Collaborating on health care regulation

In 2011, the National Council of State Boards of Nursing (NCSBN), the Federation of State Medical Boards (FSMB), and the National Association of Boards of Pharmacy (NABP) formed the Tri-Regulator Collaborative. The three organi-zations that represent the state boards that license a combined total of 5 million physicians, nurses, and pharmacists, rec-ognized a need for health care regulators to work collabora-tively on issues of state-based regulation and licensure. In October 2012, the Collaborative hosted the first-ever Tri-Regula-tor Symposium. The members and staff of many nursing, med-ical practice, and pharmacy boards from around the coun-try attended. The Symposium held two days of presentations and open forums, focused on the theme of “Protecting Patients and the Public: A Heri-tage of Excellence.” To view the 2012 symposium presentations, visit the NCSBN website (www.ncsbn.org/1346.htm).

In October 2013, leadership for the three organizations announced that they had met

to discuss issues of mutual concern and to set an agenda of work for the Collaborative. The agenda included: 1) prepa-ration for a joint meeting of the governing boards of the orga-nizations; 2) development of a proposed position statement on interprofessional team-based

care; 3) planning for a second Tri-Regulator Symposium to be held in 2015; and 4) encouraging regular dialogue between medical, pharmacy, and nurse licensing boards.

The joint meeting of the governing Boards was held on Feb. 5, 2014. Two position statements were adopted at that meeting: the “Tri-Regula-tor Collaborative Position Statement on Interpro-fessional, Team-based Patient Care” and the “Tri-Regulator Collab-

orative Position Statement on Practice Location for Consumer Protection.” Jon V. Thomas, MD, MBA, a member of the Minnesota Board of Medical Practice who was serving as the FSMB Chair noted that, “At a time of great change in health care, trends are pointing increasingly to the need for a much more team-based ap-proach to caring for patients. It makes sense for the physician community to work in close cooperation with our colleagues in pharmacy and nursing to help move a team-based care model forward.”

The second Tri-Regulator Symposium was held in Oc-tober 2015 and was themed “Team-Based Care—Collab-orative Regulation.” Board members and staff gathered at the 2015 Symposium to discuss how boards can work together and support each other as they protect the public at a time when the health care system is evolving towards new practice models and team-based care. To view the 2015 symposium pre-sentations, visit the NABP web-site (www.nabp.net/meetings/tri-regulator-symposium).

Members and staff of the Minnesota Boards of Medical Practice, Nursing, and Phar-macy attended the 2012 and 16 MINNESOTA PHYSICIAN APRIL 2016

The Minnesota Tri-Regulator Collaborative from cover

Table 1. Minnesota licensed health care professionals as of Jan. 27, 2015

Physicians 22,355

Physician assistants 2,121

Advanced practice registered nurses 7,031

Registered nurses 98,599

Licensed practical nurses 23,051

Pharmacists 8,057

Pharmacy technicians 9,887

Source: Ruth Martinez, Shirley A. Brekken, and Cody Wiberg


2015 symposia. Following the 2015 national symposium, the Boards began planning for a Minnesota Tri-Regulator Symposium, which will be held in June 2016. The purpose of the meeting is to bring together members and staff of the three boards to learn about and discuss issues of com-mon concern. Sessions will focus on the impact that the legalization of medical cannabis may have on licensing boards and on interpro-fessional practice and education. In addition, the executives of the three national organizations will give an update on recent activities, including any joint work being undertaken by the Tri-Regulator Collaborative.

Joint initiatives

The concept and value of collaboration is not new to the Tri-Regulatory Boards of Medical Practice, Nursing, and Pharmacy. In 1993, the Boards joined forces to develop a pro-gram for confidential monitor-ing of regulated individuals suffering from health condi-tions that could potentially impact practice. In 1994, the Boards appreciated the Min-nesota Legislature’s enactment of the Health Professionals Services Program (HPSP), a program jointly funded by the participating boards. While most states have now estab-lished confidential monitoring programs for specific health care professions, the HPSP model is nationally recognized for its capacity to monitor individuals across Minnesota’s regulated health care profes-sions. The program currently serves individuals regulated by the health licensing boards and the Department of Health. To learn more about HPSP, visit the HPSP website (https://mn.gov/boards/hpsp/).

The Minnesota Tri-Regula-tory Boards also participate as members of the Minnesota Alli-ance for Patient Safety (MAPS), founded in 2000 as a voluntary stakeholder coalition focused on collaborative engagement

to assure provision of safe care everywhere in Minnesota. In 2001, the Minnesota Tri-Reg-ulatory Boards collaborated with other MAPS members to advocate for changes to the

Minnesota Peer Review Statute and helped found the Minneso-ta Adverse Health Care Event Reporting Act. The Minnesota Tri-Regulatory Boards worked with MAPS on a just culture initiative and, in 2006, the Boards jointly adopted MAPS’ Statement of Support for a Statewide Culture of Learning, Justice and Accountability. Also in 2006, MAPS was a recipient of the John M. Eisenberg Pa-tient Safety and Quality Award for Innovation, in large part due to the efforts of its members to participate on work groups to study and offer guidance on such important patient safety issues as informed consent, consumer literacy, safe surgery verification, and rapid response efforts. Members and staff of the Minnesota Tri-Regulatory Boards have presented locally and nationally on MAPS’ pa-tient safety initiatives and con-tinue to participate as MAPS members. To learn more about MAPS’ history and patient safety activities, visit the MAPS website (www.mnpatientsafety.org).

Other collaborative efforts specifically address current challenges such as opioid overdose and diversion. In 2011–2012, the Minnesota Department of Health (MDH) and the Minnesota Hospital Association (MHA) invited the Minnesota Tri-Regulatory Boards and other stakehold-ers to convene as a Minnesota Controlled Substance Diver-sion Prevention Coalition

(Coalition) for the purpose of identifying best practices, increasing awareness, and providing guidance regarding controlled substance diversion. The Coalition issued its final

report in March 2012. To access the full report, visit the MDH website (http://www.health.state.mn.us/patientsafety/drug-diversion/divreport041812.pdf). The Coalition also created a road map and tool kit to guide controlled substance storage and security, procurement, prescribing, and preparation and dispensing. To access the

road map and tool kit, visit the MDH and MHA websites (http://www.health.state.mn.us/patientsafety/drugdiversion/divroadmap041812.pdf; http://www.mnhospitals.org/

patientsafety/collabo-ratives/drugdiversion- prevention). Currently, the Minnesota Tri-Regu-latory Boards are partic-ipating in a State Opioid Oversight Project work group, facilitated by the Minnesota Department of Human Services, with seven key focus areas specific to opioid abuse. The group participated in hosting a statewide con-

ference in August 2015, Pain.Pill.Problem, attended by more than 1,000 interested parties, including providers, consumers, regulators, and legislators.

Interprofessional practice

Interprofessional collab-oration is a recognized

Interprofessional collaboration is a

recognized evolving practice model.

The Minnesota Tri-Regulator Collaborative to page 42

Your Link to Mental Health ResourcesYour Link to Mental Health Resources

ADDICTION MEDICINE

My patient, Teresa, aged 43, had been practic-ing as a surgeon for 11

years when she was admitted to residential treatment for a sub-stance use disorder.

Five years prior to entering treatment, Teresa had undergone gastric bypass surgery. She did not have a history of risky alco-hol or other drug use prior to this surgery. To address postoperative pain, Teresa received liquid oxy-codone. In addition to pain relief, Teresa experienced a euphoric effect from the oxycodone and reported that she liked the way it made her feel. Additionally, after recovering from surgery, Tere-sa noticed a change in the way she responded to alcohol. She noticed a euphoric reaction to alcohol and became intoxicated more rapidly. Teresa estimates that, gradually, over three to four years, her alcohol consumption increased from drinking one or two alcoholic beverages one to two times per week to drinking five to seven alcoholic beverages most days of the week.

Teresa’s medical history in-cluded a major depressive episode at age 26. She received appro-priate treatment at the time and eventually entered full remission. She also reported a history of childhood physical and emotional abuse. Addiction runs in Teresa’s family, with both parents as well as a sibling having been diagnosed with a substance use disorder.

Two years prior to treatment admission, Teresa was injured in a motor vehicle accident that resulted in severe and persistent neck pain. Her condition was exacerbated by the fact that she needed to wear a lead apron while performing surgery. To help with the pain, Teresa received a few prescriptions for Percocet from

her primary care physician, who happened to also be a personal friend. Her use of prescription opioids increased over time, and eventually, she began diverting fentanyl from the hospital where she worked. At first she used the fentanyl intranasally, but soon be-gan taking the drug intravenous-ly. She found that the fentanyl not only eased her physical pain but also improved her mood and allowed her to work longer hours.

When it was discovered that she had been diverting fentanyl from the workplace, Teresa was immediately terminated by her employer. She reported herself to the state monitoring program, as required. In turn, the state moni-toring program was mandated to inform the state medical board of the matter because diversion of controlled substances was involved.

By the time of Teresa’s admis-sion to residential addiction treat-ment, she had lost her health, her career, and her self-respect. As a surgeon who held herself to the highest professional and ethical standards, Teresa was over-whelmed by feelings of guilt and shame—the emotional fuel that drives the disease of addiction, especially among physicians.

The hallmarks of effective treatmentAs Teresa’s case demonstrates, substance use disorders can be particularly complex for physi-cians. The very strengths and characteristics prized in physi-cians—problem solvers, healers, caregivers, and perfection-ists—can be stumbling blocks to recovery. Physicians also face workplace challenges that can complicate sustained recovery, such as easy access to controlled substances, extensive knowledge of pharmaceuticals, irregular shift work, long hours, repeated emotional trauma, workplace injury causing chronic pain, and other risks and threats.

But with an evidence-based treatment program and spe-cialized support—including an individualized care plan, a multidisciplinary care team, a patient cohort of other health care professionals, ongoing support and accountability, and assistance with career restoration—addiction can be successfully treated and managed for the physician, for life.

Individualized planning: Because addiction affects brain function and behavior, no single treatment is effective for all patients. In developing an individualized treatment plan, clinicians consider multiple variables, including types of substances used, physical and mental health, work history, gender, family relationships, and many other factors. Addressing all such factors is essential in developing the most effective treatment plan to help physi-cians get well and stay well.

A multidisciplinary ap-proach: More often than not, addiction comes with co-occur-ring conditions, such as mental health issues related to anxi-ety, trauma, or depression. It’s important to address all aspects of the disease by involving addiction counselors, medical and mental health professionals, spiritual care providers, family therapists, nutrition and wellness specialists, and other experts as appropriate for the individual patient. For obvious reasons, many physicians struggle with taking on the role of patient rath-er than caregiver. Clinicians who understand this dynamic can help patients become appropri-ately vulnerable and trusting in the treatment setting.

A patient cohort of other physicians: Physicians tend to enter addiction treatment at a progressed stage of the disease because their denial structure is so fortified. The walls have been built up through the sacrifice and determination it takes to achieve a career in medicine. Be-ing in a treatment environment with a cohort of physicians and other health care profession-als—colleagues who understand the workplace dynamics, pres-sures, and obligations—allows for those intellectual defense structures to start coming down.

Addiction treatment for physiciansReclaiming health and career

By Marc Myer, MD


Patients gain insight and the ability to manage the count-er-transference of those addic-tive behaviors that cause the most guilt and shame.

Ongoing support and account-ability: Emerging research about what makes recovery last shows that the longer patients remain engaged in care and support, the better the long-term outcomes. Physicians have extremely impressive recovery rates, matched only by airline pilots. For both populations, the combination of continuing care, coordinated services with monitoring and licensing agen-cies, and mandated drug testing in early recovery provides an intensive level of support and accountability. Ongoing ther-apy, support group participa-tion, recovery coaching, and web-based recovery support are effective options for strength-ening and reinforcing recovery practices.

Assistance with career res-toration: Because physicians work in what’s classified as a safety-sensitive role, preparing for the successful return to practice typically requires in-volvement with licensing or dis-ciplinary agencies and partici-pation in monitoring programs. Comprehensive treatment programs offer assistance and guidance in all aspects of the return-to-practice transition.

Addiction is a disease, and physicians aren’t immuneWhile the lifetime prevalence of addiction among health care professionals is similar to that of the general population—estimated at between 8 and 13 percent—there are important distinctions. Surgeons, espe-cially female surgeons, have significantly higher rates of alcohol use disorders than the general population. The types of substances misused are also dif-ferent. Physicians are five times more likely to abuse opioid pain

medications and benzodiazepine anti-anxiety drugs than the general population, which is attributable, at least in part, to greater access to and familiarity with these drugs.

Compared with other chron-ic conditions, such as heart disease or diabetes, addiction carries a heavy stigma. But like other chronic diseases, addiction can be treated and managed effectively. For health care professionals in particular, recovery outcomes are extreme-ly impressive. Physicians who complete a treatment program and engage in ongoing moni-toring and return-to-practice planning have recovery rates as high as 90 percent at three to five years post-treatment. That compares with recovery rates among the general population of less than 50 percent at one year post-treatment. Based on rates of medical malpractice cases, research also indicates that physicians who are in ac-tive recovery from addiction are among the safest practitioners in the profession.

Physicians who are con-cerned they might have a prob-lem with alcohol or other drugs can find help and answers, confidentially, from profession-als who will assist with assess-ment, evaluation, and referral services. A starting place for many is the Minnesota Health Professionals Services Program (HPSP), a state agency that co-ordinates diagnosis, treatment, and monitoring services for health care practitioners.

Today, Teresa is reclaiming her life in every respect. She successfully completed a 90-day residential addiction treatment program and worked with her treatment team to carefully con-sider and determine if and when she would return to medical practice. In her case, the deci-sion was made that she would not return to surgical practice. The risk of relapse was too great given Teresa’s chronic neck pain,

history of depression, family history of addiction, prior intra-venous drug use, and workplace access to opioids. The team also acknowledged the fact that opi-oid relapse carries an extremely high risk of overdose.

Teresa was able to retain her medical license and is working in medical software development. Because she was charged with felony diversion of controlled substances and placed on proba-tion, her ability to practice med-icine remains under scrutiny. As she works to resolve remaining challenges, Teresa is looking into pursuing a fellowship in addic-tion medicine.

Marc Myer, MD, is director of the Health Care Professionals Program at Hazelden in Center City, Minnesota. As a board-certified addiction spe-cialist, his practice focuses on helping physicians, nurses, and other health care providers find freedom from ad-diction. He is a fellow of the American Society of Addiction Medicine and serves as president-elect of the Minne-sota Society of Addiction Medicine.

Physicians who are in active recovery from addiction are among the safest

practitioners in the profession.

Addiction may be difficult to detect, as health care professionals are very skilled at presenting themselves well. Their career tends to be the last thing affected.

1. Rapid mood swings (from euphoria to anger or irritability)

2. Frequent absences from work

3. Over-sedation—falling asleep on the job

4. Poor record keeping or documentation

5. Deterioration of hygiene or physical appearance

6. Not following proce-dures for proper disposal of controlled substances

7. Exhibiting signs of substance use withdraw-al: shaking, sweating, fatigue, loss of appetite, nausea, and vomiting

Seven signs that your health care professional colleague is struggling with addiction


Your Link to Mental Health ResourcesYour Link to Mental Health Resources

PROFESSIONAL UPDATE: OPHTHALMOLOGY

Presbyopia is a common visual complaint for many individuals as they

near the age of 40 and beyond. When people develop presby-opia, they find themselves hold-ing books, magazines, newspa-pers, menus, and other reading materials at arm’s length in order to focus properly. When they perform near work for any length of time, such as embroi-dery or handwriting, they may develop headaches, eyestrain, or feel fatigued.

Presbyopia is an age-related condition and is generally believed to stem from a gradual thickening and loss of flexibility of the natural lens inside the eye. This differs from astigma-tism, nearsightedness, and far-sightedness, which are related to the shape of the eyeball and are caused by genetic and envi-ronmental factors. Age-related change occurs within the proteins in the lens, making the lens harder and less elastic over time. Changes may also take place in the muscle fibers

surrounding the lens, which prevents the eye from being able to focus up close.

Presbyopia continues to progress over time. For exam-ple, someone who is 45 may only notice it when trying to read tiny print in low light. However, someone who is 55 may depend more and more on reading glasses or contact lenses to see while focusing on near vision tasks throughout the day. The need for reading glasses is part of growing older, but for many people it can be downright uncomfortable and frustrating. Now an advanced device, approved by the FDA,

may offer certain individuals with presbyopia a new way of addressing this condition.

A new device

Developed by AcuFocus, the KAMRA corneal inlay received FDA approval for use in the United States in April 2015. The device received a CE mark in 2005 for the European Eco-nomic Area, allowing it to be marketed in over 50 countries across Europe, Asia, South America, and the Middle East.

The inlay is designed to reduce the need for reading glasses among people age 45 and over who have good distance vision without glasses, but have problems seeing up close due to presbyopia. The goal of the inlay is to restore everyday near vision, so the patient can once again see text messages, read a computer screen, and see the time on their wristwatch, without always needing reading glasses.

The KAMRA inlay is smaller than a contact lens—just 3.8 millimeters (about 0.15 inch) in diameter and 6 microns thick (about half the thickness of plastic wrap used to store food). It consists of an opaque outer ring and a tiny (1.6 mm) central opening that is placed directly in front of the center of the pupil. It works on the same principle as a small camera aperture by increasing the depth of focus. The central opening of the inlay allows only focused light into the eye, enabling an individual to see near, far, and everything in-between.

KAMRA inlay vs. other refractive procedures

The KAMRA inlay is not to be confused with LASIK, or other refractive procedures. In LASIK

and similar procedures, laser energy reshapes the curvature of the eye’s cornea to alter the way light rays focus on the ret-ina. Artificial lenses surgically inserted into the eye can also refocus light to sharpen vision.

Monovision LASIK leaves one eye in focus for far vision, and the other eye corrected for near vision tasks. Patients will get improved near vision, but will have some diminished capacity to see at a distance and loss of depth perception. While monovison works well for most patients, some people who have monovision LASIK have diffi-culty adapting and experience a sense of feeling off balance, and loss of depth perception. Fur-ther, the improved near vision that the procedure produces can decrease as the patient ages and the presbyopia progresses.

The KAMRA inlay is typical-ly implanted in the non-domi-nant eye, so the distance vision of the patient’s dominant eye is completely unaffected and the patient retains distance vision in both eyes.

Corneal inlay surgery may be combined with refractive corneal laser (LASIK and PRK) surgery to correct presbyopia, as well as nearsightedness, farsightedness, and/or astig-matism. This was not a part of the IDE (investigational device exemption) study and is con-sidered an “off-label” use of the procedure in the United States. However, it is routinely per-formed with great success.

Who is not an ideal candidate?

The KAMRA inlay does not reduce nearsightedness or farsightedness. A common situation is someone who has both nearsightedness and pres-byopia or farsightedness and presbyopia. In these patients, the nearsightedness or farsight-edness can often be improved with LASIK, PRK, or Natural

The KAMRA corneal inlay

Maintaining a natural range of vision

By Richard L. Lindstrom, MD, and David R. Hardten, MD, FACS

The entire procedure typically takes less than 20 minutes.


Lens replacement (where the natural lens is replaced with a lens implant). In patients over age 60, mild lens opaci-ties often exist where Natural Lens replacement (even using a multifocal or accommodat-ing intraocular lens implant) may be a better option. Many options exist and during the eye examination, the surgeon can determine the best option to achieve the patient’s goals.

Who is the ideal candidate?

The KAMRA inlay is ideal for people who want to reduce their dependency on reading glasses. The device is indicated for people 45 to 60 years old, who have normal distance vision but require reading glasses between +1.0 and +2.5 diopters of power.

The device is not intended for patients who have severe dry eye; an active eye infection or inflammation; corneal abnor-malities related to thinning and irregular shape of the surface of their eyes; insufficient cor-neal thickness to withstand the procedure; a recent or recur-ring herpes eye infection or problems resulting from past infection; uncontrolled glauco-ma; uncontrolled diabetes; or active autoimmune or connec-tive tissue disease.

Procedure details

The KAMRA inlay is the num-ber one prescribed corneal inlay in the world and provides an excellent, long-term range of vision from near to far. The entire procedure typically takes less than 20 minutes. Numbing drops are used to ensure the patient’s comfort throughout the procedure.

Using a femtosecond la-ser, the surgeon creates a small pocket in the cornea and places the inlay into the pocket and centers it over the pupil. Patients will feel a slight pressure from the laser during

the creation of the pocket, but should experience no pain and little discomfort. There are no stiches or bandages needed. However, post-operatively the patient will need to use eye drops for a period of time to ensure proper healing.

As with any eye surgery, healing is a process. The recovery time (when patients will notice an improvement in near vision) will depend on their personal healing patterns. While some patients see an im-provement within the first week to a month, others may require additional time.

It is important to under-stand that there may be times when additional magnifica-tion, usually standard reading glasses, is needed to read small print in dim light or to perform a near task for an extended period of time.

FDA approval and outcomes

To evaluate the safety and efficacy of the KAMRA inlay, the FDA reviewed the results of three clinical studies. The results of the main study showed that 83.5 percent of the evaluable 507 participants achieved uncorrected near visual acuity of 20/40 or better at 12 months. This is the level of vision needed to read most

text in magazines and news-papers. An average three line gain was achieved at 12 months and remained stable over the remainder of the study.

Before considering the KAM-RA inlay procedure, individuals should have a complete eye ex-amination. Eye surgeons should discuss the potential benefits, complications, risks, and time required for healing with pa-tients. If the visual effects are not ideal, the inlay can be surgi-cally removed at a later point.

Conclusion

In summary, the KAMRA corneal inlay is a very favorable

option for individuals interested in maintaining a natural range of vision—from near to far. As the only presbyopia proce-dure utilizing small aperture optics, the KAMRA inlay offers treatment for near, or reading vision. With the KAMRA inlay, patients receive a:

• FDA approved sustainable near vision solution

• Complete uninterrupted range of vision

• Minimally invasive surgi-cal procedure

• Treatment that leaves the natural lens in place

• Lasting uncorrected vision improvement at near

Richard L. Lindstrom, MD, is founder and attending surgeon of Minneso-ta Eye Consultants and an adjunct professor emeritus at the University of Minnesota Department of Oph-thalmology. He is board-certified in ophthalmology. David R. Hardten, MD, FACS, is board-certified in oph-thalmology and is a founding partner of Minnesota Eye Consultants.

The inlay is designed to reduce the need for reading glasses.


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also become more prevalent in those with HFrEF, as supported by the Randomized Aldactone Evaluation Study (RALES) (Pitt et al., 1999) and Eplerenone in Mild Patients Hospitalization And Survival Study in Heart Failure (EMPHASIS) studies (Zannad et al., 2011). Cardiac resynchronization therapy for ventricular dyssynchrony, and implantable cardioverter defibrillators for sudden cardi-ac death prevention, have also become a cornerstone therapy for severe heart failure. Howev-er, the United States Food and Drug Administration (FDA) had not approved a new drug for heart failure for a decade since 2005. Therefore, there was sig-nificant interest in the develop-ment of novel therapeutics for the treatment of heart failure.

In heart failure, there is cardiovascular dysregulation leading to vasoconstriction, fluid retention, proinflammation, and adverse cardiac remodeling.

There is both a vasoconstrictive pathway as well as a vasodilatory pathway, and upregulation and downregulation of these path-ways are central to the underly-ing dysfunction present in heart failure. Given this pathophysiol-ogy, the renin angiotensin aldo-sterone pathway, which leads to vasoconstriction and hyperten-sion, has been an often-studied pathway in heart failure. As a mediator of proconstriction, antagonism of this pathway has been important in the treatment of systolic heart failure.

However, vasodilatory pathways are also important, and potentiation may lead to enhanced outcomes in heart failure. Another neurohormonal pathway that has been studied extensively in cardiovascular

disease includes the natriuretic peptide (NP) system, a family of potent vasodilatory hormones. NPs have important cardiorenal properties, which include vaso-dilatation, natriuresis, and im-provement in cardiac remodel-ing through anti-inflammatory and anti-proliferation proper-ties (Levin, Gardner, & Samson, 1998). Thus the physiologic and pathophysiologic studies of the NP system sparked a search for a therapeutic agent that may lead to improved clinical out-comes in heart failure.

Two additional important vasodilatory regulators include bradykinin and adrenomedul-lin. Bradykinin is a potent vaso-dilatory mediator important in inflammation and tissue injury. Since bradykinin is degraded by angiotensin converting enzyme (ACE), the use of ACE inhibitors led to increased circulating levels of the peptide bradykinin, contributing to reduced blood pressures. However, bradykinin has also been implicated in angioedema.

Adrenomedullin is also a vasodilatory peptide that importantly is degraded by Neprilysin. Adrenomedullin, in addition to its potent vaso-dilatory effect, also augments myocardial contractility. It has been implicated in heart failure due to elevation in levels in those with diastolic dysfunction compared to normal subjects. Furthermore, those with heart failure appear to have an at-tenuated vasodilatory response to adrenomedullin infusion compared to normal subjects (Nakamura et al., 1997).

The history of Neprilysin and Neprilysin inhibition

In the 1990s, there was signifi-cant interest and research into neutral endopeptidase (NEP), or Neprilysin, and its role in car-diovascular diseases. NEP is a metalloprotease that degrades a

range of different peptides found throughout the body, from bra-dykinin to amyloid beta peptide to natriuretic peptides (Erdos & Skidgel, 1989). Neprilysin was initially discovered in the kidney, where it is most abun-dant, and serves as a membrane protein responsible for cleaving different peptides (Turner, Isaac, & Coates, 2001). NEP found in the brain and neuronal cells were responsible for turning off neurosignaling. It has been implicated in cancer cell signal-ing. NEP in the cardiovascular system is important in degra-dation of vasodilatory peptides. Given the beneficial effects of the natriuretic peptide system, as well as its dysregulation in heart failure, NEP became a focus as a potential heart fail-ure drug. Since NEP degrades natriuretic peptides, Neprilysin inhibition (NEPI) may lead to beneficial cardiorenal effects in heart failure.

In 1990, Cavero et al. in-vestigated the effects of NEPI in heart failure. Their promis-ing results demonstrated that NEPI, when administered with atrial natriuretic factor, poten-tiates endogenous natriuresis. Furthermore in 1991, Margulies et al. demonstrated in large animal models that NEPI may have a renal potentiation effect when combined with angioten-sin inhibition for congestive heart failure. Candoxatril, an oral NEPI, showed promising results in heart failure, with demonstration of improve-ment in left ventricular filling pressures (Elsner et al., 1992). Throughout the 1990s, there remained optimism with NEPIs in congestive heart failure (Margulies, Barclay, & Burnett, 1995). Beneficial renal NEPI ef-fects were found to be particu-larly marked in those with mild heart failure, with improvement in natriuresis and renal hemo-dynamics (Chen et al., 1999). In addition to NEPI’s effects in those with heart failure, NEPIs have also been studied in hypertension, given the vasodil-atory and hypotensive effects of the NPs, although with mixed results (Bevan et al., 1992).

A breakthrough in heart failure treatment from cover

[The] FDA had not approved a new drug for heart failure for a decade.

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A breakthrough in heart failure treatment to page 38


Vasopeptidase inhibition

In the early 2000s, there were multiple human clinical trials investigating the efficacy of omapatrilat, a vasopeptidase inhibitor that has properties of both NEP inhibition and ACE inhibition. The Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE) trial in 2002 showed that omapatrilat trended towards reduction in mortality and hospitaliza-tion compared to ACEI alone (Packer et al., 2002). Omapa-trilat was also found to have a benefit in exercise tolerance in the Inhibition of MetalloProte-ase by BMS-186716 in a Ran-domized Exercise and Symp-toms Study (IMPRESS) trial (Rouleau et al., 2000).

In addition to the favor-able findings in heart failure, omapatrilat was found to be promising in patients with hypertension. The Omapatri-lat Cardiovascular Treatment vs. Enalapril (OCTAVE) trial showed that omapatrilat, when compared to ACE inhibition alone, had significantly im-proved blood pressure control (Kostis et al., 2004). However, the investigators also reported increased angioedema among those taking omapatrilat. Despite all the enthusiasm for NEPI, the findings associated with angioedema risk proved to be its undoing.

There was great enthusi-asm when FDA approval was sought for omapatrilat, given the results of large human trials demonstrating efficacy when compared to ACEI alone. However, given that both ACE and NEP are involved in the breakdown of bradykinin, the inhibition of both pathways led to a greater angioedema risk than either agent alone. This proved to be the downfall of omapatrilat, and it was never granted FDA approval given the potential life threatening side effects of the drug compared to conventional therapy at that time. After the failure of omapa-trilat FDA approval, the initial wave of enthusiasm for NEP in-hibition was dampened. Despite these setbacks for Neprilysin

inhibition, chronic potentiation of natriuretic peptides remained promising, with chronic admin-istration of B-type natriuretic peptide (BNP) demonstrating favorable cardiorenal results (Chen et al., 2000).

The rise of ARNI

Given that omapatrilat demon-strated promising efficacy results, but was not approved due to the side effect of angioedema risk, investigation focused on an effective NEPI agent combined with a renin angiotensin aldosterone agent that would decrease the risk of angioedema. LCZ696, a combi-nation of sacubitril (NEPI) and valsartan (angiotensin receptor blocker, ARB), was designed to reduce the risk of angioedema. This heralded a new age of the angiotensin receptor Neprilysin inhibitor (ARNI).

The Prospective Comparison of ARNI with ACEI to Deter-mine Impact on Global Mor-tality and Morbidity in Heart Failure (PARADIGM) trial was a prospective, multicenter, randomized trial of over 8,000 patients with chronic heart failure with reduced ejection fraction, comparing LCZ696 (ARNI) with enalapril (ACEI) (McMurray et al., 2014). The trial was stopped early, with a median follow up of 27 months, given overwhelming benefit in the ARNI group. McMur-ray et al. found that LCZ696 compared to enalapril reduced mortality (13.3 percent versus 16.5 percent, p<0.001) and heart failure hospitalization (12.8 percent versus 15.6 percent, p<0.001). Published in 2014, the PARADIGM trial led to the eventual approval of LCZ696 (valsartan/sacubitril) by the FDA in July 2015 for chronic heart failure (New York Heart Association NYHA Class II-IV) with reduced ejection fraction.

Since the success of LCZ696, there have been multiple

sub-studies analyzing the popu-lations that derive the most ben-efit from this new medication. When analyzing the risk of pro-gression of heart failure when comparing ARNI with ACEI, it was found that LCZ696 more

effectively prevented clinical worsening in those with heart failure (Packer et al., 2015). In determining if age mattered as to which patients derived a greater benefit from LCZ696, it was found that there was a significant benefit for the ARNI across all age groups studied (Jhund et al., 2015). Additional-ly, in an analysis based on the mild symptoms of the majority of patients in the PARADIGM study, it was found that despite mild symptoms, heart failure

patients were still at high risk for poor outcomes (Simpson et al., 2015). Given the short period of the study with a large benefit, it was concluded that LCZ696 had a large spectrum of benefit regardless of the severi-ty of patient symptoms.

Future directions

There remain many questions and future areas of study regarding the use of LCZ696.

Heart failure with preserved ejection fraction

One of the main questions that remain regarding ARNI is whether or not it would be the first drug demonstrated to have a mortality benefit in heart failure with preserved ejection fraction (HFpEF). Comprising approximately half of all heart failure patients, HFpEF remains elusive regarding a treatment modality. The Prospective Com-parison of ARNI with ARB on Management of Heart Failure

LCZ696 more effectively prevented clinical worsening in those with heart failure.

Heart Failure Study Seeking Volunteer ParticipantsThe Minneapolis Heart Institute Foundation® is recruiting patients for a stem cell trial sponsored by the National Institutes of Health (NIH). This research study will be the first cardiac stem cell trial in the United States to deliver a combination of two different investigational stem cells to the heart. The study hopes to determine the safety, efficacy and feasibility of the stem cells in improving new blood vessel growth blood supply to the heart, and the heart’s ability to pump blood.If you have a reduced ejection fraction (LVEF < 40%) due to previous damage from heart attacks or coronary artery disease, you may qualify for this study. Testing is provided at no cost to you.To learn if you may be eligible for this research, please contact: Terri Arndt at 612-863-7821 or [email protected].

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WOMEN’S HEALTH

Pregnancy and birth is often a joyful occurrence in the lives of women

and families. Minnesota ranks at the top of the nation on many indicators of health and health care, but not everyone in the state enjoys good health and easy access to services. In particular, Minnesota’s Afri-can-American and American Indian communities experience disproportionately high rates of poor birth outcomes, includ-ing preterm birth, which is a leading contributor to infant mortality. Over a five-year period (2006–2010), the average infant mortality rate for white infants in Minnesota was 4.4 per 1,000, while the rate for African-American and Amer-ican Indian infants was more than twice as high, at 9.8 and 9.1 respectively per 1,000 births. This translates to a startling statistic: African American and American Indian babies in Min-nesota have double the chances of dying in the first year of life, compared with white babies.

Minnesota is taking steps to understand why these dispar-ities exist and laying out plans for their elimination. Reports such as the Minnesota Depart-ment of Health (MDH) Rural Health Advisory Committee Report on Obstetric Services in Rural Minnesota (2013), Ad-vancing Health Equity in Min-nesota Report (2014), and the Infant Mortality Reduction Plan (2015), explain the role that structural factors—including historic disadvantages, systemic disenfranchisement, and insti-tutional racism—play in perpet-uating these disparities. While efforts to reduce disparities are necessarily complex, there are evidence-based interventions that can be implemented now

in clinical settings. Culturally informed doula care is one promising evidence-based supportive practice that holds promise for disrupting the well-worn pathways between the social determinants of health and racial/ethnic disparities in birth outcomes.

What is a doula?Doulas are trained professionals who provide continuous, one-on-one emotional, physical, and informational support before, during, and after delivery. They are not medical professionals and do not provide medical services, but work alongside nurses, obstetricians, midwives, and other health care providers. In many cases, doulas provide support during pregnancy as well as labor and delivery.

Continuous support during labor and childbirth has been shown to benefit women at the time of childbirth. While such support can be provided by husbands, partners, sisters, mothers, friends, or medical staff (such as labor nurses), a 2013 Cochrane meta-analysis of 12 trials and more than 15,000 women demonstrated that the presence of continuous one-on-one support during labor and delivery was most effective when provided by a profession-al (i.e., not a friend or family member) who is not employed by the hospital (i.e., not a nurse, midwife, or doctor).

Approximately 6 percent of U.S. women who gave birth in 2011 and 2012 reported that they had support from a doula. Prior research shows that both doulas and their clients tend to be white upper-middle class women. In Minnesota and across the U.S., doula care has rarely been accessible for low-income women because of the costs, which are generally not covered by health insur-ance. A typical doula package costs between $800 and $1,500

(and could be much higher), and includes two to three pre-natal visits, continuous support during labor and delivery, and one to two postpartum visits. These services are cost-prohib-itive for many families, leaving most low-income women, who are at highest risk for poor birth outcomes, without an op-tion for support from a doula.

The benefits of doula supportThe research is abundant and clear on the benefits of doula support, which is associated with higher rates of sponta-neous vaginal birth, lower cesarean rates, shorter labors, less use of epidurals and other pain medications, and overall higher levels of satisfaction. In addition, infants born to doula-supported mothers were less likely to have low five-min-ute Apgar scores, a key early metric of infant health. All of these findings are supported by the aforementioned Cochrane meta-analysis.

Doctors recognize these benefits and support increased access to doula services. In March 2014, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine issued a joint statement on safe prevention of cesarean delivery which noted, “Published data indicate that one of the most effective tools to improve labor and delivery outcomes is the continuous presence of support personnel, such as a doula.”

Ample prior research ad-dresses the positive clinical and psychosocial outcomes of doula care in general popula-tions, but our work has focused on Medicaid beneficiaries and communities of color as well as the policy aspects of doula sup-port. Our research has shown that when low-income women have access to doula care, they experience better outcomes than Medicaid recipients in general. This means taxpay-ers who finance 42 percent of births in Minnesota through the Medicaid program may see better value for our state invest-ment in childbirth care when doula services are covered. Our 2013 study, published in the

Doula-assisted birthImproved outcomes and lowered costs

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American Journal of Public Health, was a critical factor informing the passage of the legislation allowing for Med-icaid reimbursement of doula care in Minnesota.

Medicaid coverage of doula services in MinnesotaIn May 2013, Minnesota passed a law requiring Medicaid pay-ment for services provided by a certified doula (Minnesota Statutes, section 256B.0625, subd. 28b, Covered Services: Doula Services). In so doing, Minnesota became the second state in the U.S. (after Oregon) to extend Medicaid coverage to include doula services. The law became effective on Sep. 25, 2014, after federal approval by the Centers for Medicare & Medicaid Services.

The law requires Minnesota Health Care Programs to cover doula services provided by certified doulas for fee-for-ser-vice (FFS) recipients. Medicaid beneficiaries enrolled in man-aged care must verify eligibility and confirm coverage of doula services with their managed care organization (MCO). Covered services are childbirth education and support services, which include emotional and physical support before, during, and after delivery. The Minne-sota Department of Human Ser-vices Provider Manual explains that doula services include up to six prenatal or postpartum visits and support during labor and birth. To be eligible to provide these services, certified doulas must meet requirements set forth in the law, and sub-mit a fee to be listed online in the Minnesota Doula Registry (http://www.health.state.mn.us/divs/hpsc/hop/doula/).

New evidence: preterm birth and cost-effectivenessMinnesota’s new law provided an opportunity to remove finan-cial barriers to access to an evi-dence-based service for low-in-come Minnesota mothers. And our new research, published in January 2016 in the journal Birth, revealed that doula care for Medicaid beneficiaries may also create value by reducing rates of preterm birth.

Doula care and preterm birthIn Minnesota, as in the Unit-

ed States, there are pronounced and persistent racial/ethnic inequities in the rate of preterm birth. Even after decades of research and public health ini-tiatives this disparity remains relatively unchanged, and effec-tive means of reducing preterm

birth risk remain scarce. Our latest study showed that, after adjusting for covariates, Med-icaid beneficiaries with doula care had 22 percent lower odds of preterm birth, compared with Medicaid beneficiaries generally, shining a ray of hope on this recalcitrant issue. According to the National Vital Statistics Reports, in 2013 near-ly one in nine births in the U.S. was preterm, and one in three was born by cesarean. More than one-third of all infant deaths in 2010 were attributed to preterm-related causes, and preterm birth costs the U.S. health care system more than $26 billion annually.

While prior studies have shown a reduction in cesarean rates associated with doula care, ours was the first study to show statistically lower rates of preterm birth among Medicaid beneficiaries with doula support. Given the longstanding racial disparities in preterm birth and infant mortality, the study’s findings on preterm birth are particularly relevant for equity concerns. More important, our study focused on women who had doula support during preg-nancy, not just during labor and birth (all had at least one doula visit during pregnancy, and most had three visits). For doula sup-port to influence preterm birth, it’s important that the doula has a chance to build a relationship over the course of the pregnan-cy, making multiple visits, and providing support that is per-sonally and culturally relevant for each pregnant person.

Cost-effectiveness of doula careNot only is doula support

associated with lower preterm birth rates, but it also creates value. Our statistical analysis of more than 67,000 Medic-aid-funded births estimated that, on average, a Medicaid reimbursement rate of $986 for doula support would be cost

neutral to the program. That is, the amount the Medicaid pro-gram spends on doula services would be offset by decreases in the costs associated with preterm and cesarean births at an average reimbursement rate of $986. To arrive at this estimate, we compared preterm and cesarean birth rates for doula-supported births among Medicaid beneficiaries in

Minnesota with preterm and cesarean birth rates for an ap-proximate 20 percent sample of births to Medicaid beneficiaries in 12 states in the West North Central and East North Central U.S. The cost-effectiveness anal-ysis compared usual care and benefits against usual care plus doula support during pregnan-cy, labor, and delivery.

Previous studies have shown health benefits of doula support for mothers and their babies, and obstetricians recommend that people who are pregnant have doula support; our anal-ysis brings these recommen-dations into the context of the financial decisions Medicaid programs and other health plans make when they consid-er which services to cover. We found, on average, across the 12 states studied, access to dou-la-supported deliveries among Medicaid beneficiaries in these states could save $58.4 million and eliminate 3,288 preterm births per year.

Minnesota became the second state in the U.S. to extend Medicaid

coverage to include doula services.

Doula-assisted birth to page 40

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Carol Nelson, MDBoynton Health Service

The chance to improve the high maternal and child mortality rate in rural Tikonko, Sierra Leone inspired

Dr. Carol Nelson, a primary care physician at Boynton Health Service at the University of Minnesota, to volunteer. Sierra Leone is extremely poor and still recovering from a civil war and last year’s Ebola outbreak. There are only 120 doctors in the entire country and a lack of adequate health care. One in 17 women die related to pregnancy or childbirth, and life ex-pectancy is only 46. Malnutrition and stunting is very common among the children.

Nelson traveled to Tikonko in 2013 and 2015 through the Rural Health Care Initiative (RHCI), which was founded by Alice Karpeh, a nurse at Boynton, who was born in Tikonko, and is determined to improve health care in her village. RHCI’s mission is to partner with the Tikonko Community Health Center to give the health care workers the knowledge and resources they need to provide quality, life-saving care especially for pregnant women and their children. RHCI has donated a solar suitcase that sup-plies power, and much needed medication and medical supplies to the Health Center.

They are currently raising funds to build a birth waiting home for pregnant women so the women are close to care and can avoid walking long distances while in labor. Nel-son pointed out, “The birth waiting home is one part of the plan to reduce maternal and newborn morbidity and mortality.” RHCI is also collaborating with the Health Center to operate an outreach motorbike clinic that goes to one of four villages each Friday to provide vaccines and primary care.

The Health Center has no doctors or advanced health care professionals, but is staffed by a nurse midwife, health aids, a community health worker, a health assistant, and unpaid traditional birth attendants (TBAs). TBAs are a critical link

between the villages in the chiefdom and the Health Center, so RHCI chose to focus on training them because they have little or no formal medical training. In July and August 2015, Nelson was part of a collab-orative team from RHCI and Midwives on Missions of Service to train TBAs to become community health workers. Thirty TBAs passed a certification exam after taking a three-and-a-half week course on basic anatomy, physiology, nutrition, infec-

tion prevention, antenatal and postnatal care, labor, delivery, and newborn care. The course also stressed that women

can be agents of change in their communities.

Inspired by her volunteer work, Nelson is earning an MPH degree at the University

of Minnesota School of Public Health. According to Nelson, “My volunteer work gives me a stronger sense of purpose in my life. I’ve learned that doing long-term sustainable work in developing countries is critical, as

opposed to limited short trips. Medical volunteering in low-resource countries is about understanding the culture and the importance of community involvement. That makes a real difference.”


Recognizing Minnesota’s Volunteer Physicians and Health Care Providers

Each year, Minnesota Physician Publishing recognizes physicians and health care providers who have volunteered their medical services. Whether volunteering at home or overseas, these caregivers help people in need and come away with a revitalized sense of their work. Their compas-sion, commitment, and generous spirit reflect the deeply held values in Minnesota’s medical community.

By Lisa McGowan

Making a difference in Minnesota and the world

Long-term sustainable work in developing countries is critical.

2016 Community Caregivers

Vibhu Kshettry, MDMinneapolis Heart Institute at Abbott Northwestern Hospital

Twenty years ago, Dr. Vibhu Kshettry began going on cardiac surgery missions to India and Ethiopia to

operate on indigent children and young adults. The death rate in these develop-ing countries is high because of a lack of trained medical personnel and limited access to medical care. Cardiovascular disease is a leading cause of death glob-ally and there is a great need for cardiac care in India and Ethiopia. Kshettry re-alized that surgical mission trips helped a lot of children, but did not solve the overall problem of a lack of medical pro-viders. “These missions were saving lives, but the sustainability and impact on the host country was limited,” said Kshettry.

In 2005, Kshettry established the International Cardiac Outreach Research and Education (ICORE) program at the Minneapolis Heart Institute Foundation in an effort to train nurses, technicians, and physicians in developing countries. ICORE partnered with the Institute of Cardiac Sciences in Bangalore, India to educate medical staff on the latest in cardiac care.

Training in India is cost effective and the trainees gain experience in treating diseas-es that are common in their countries such as congenital and rheumatic valvular heart diseases. ICORE has trained 250 nurses, 60 technicians, and 30 physicians so far.

In 2009, Kshettry was approached by the Minnesota Ethiopian community to help staff the Cardiac Centre of Ethiopia in Ad-dis Ababa, the only such center in the coun-try. The Cardiac Center had the necessary equipment to perform cardiac surgery but no trained personnel. In response, Kshettry began the Children’s Heart Fund of Ethio-pia, Minnesota (CHFE) in 2013 to address

the personnel shortage. Last year, the CHFE sponsored six Ethiopian trainees to spend three years at the Institute of Cardiac Sciences in Bangalore to become cardiolo-gists, cardiac surgeons, and anesthesiolo-gists. Once their training is complete, they

will return to Ethiopia ready to practice

on their own. The CHFE also sponsored a study to track the pattern of cardiac diseases in Ethiopia.

During his childhood in India, Kshettry saw his father, a surgeon, treat all patients who came to him even when they were unable to pay. His father stressed how important it was to make a difference in these people’s lives.

Kshettry continued his father’s philosophy by volunteering as a boy and throughout his career as a surgeon. According to Kshettry, “Working with underserved populations offers valuable insight into their lives. It’s amazing how much you can do with limited resources in other parts of the world.”


2016 Community Caregivers to page 28

It’s amazing how much you can do with limited resources in other parts of the world.

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Mark Marshall, PA-C Thomas Bracken, MDMille Lacs Health System

A week after the earthquake hit Haiti in 2010, Mark Marshall traveled to a field hospital in the Dominican

Republic and then to an orphanage in Haiti to tend to earthquake victims. Haiti is the poorest country in the Western Hemisphere and the need for medical care is great even under nor-mal circumstances. Many Haitians have little or no access to health care, so Marshall returned to Haiti a few months after the earthquake to help establish an outpatient clinic affiliat-ed with the Mercy Village Orphanage in the Santo region of Port-au-Prince. Initially he ran the clinic under tarps in the orphanage yard, and managed to immunize and treat a large number of people. After the orphanage closed in 2013, the clinic moved to the House of Presence, run by a Catholic charity on the outskirts of Croix-des-Bouquets. Dr. Thom-as Bracken first went to work with Marshall in Haiti in 2011 after hearing him talk about the lack of care, food, and sanitation that most people experience.

Both work at Mille Lacs Health System in Onamia, where Marshall works as an emergency medicine physician assistant and Bracken as a family physician. They are very humble about their work in Haiti. Ac-cording to Marshall, “Our desire to provide medical services to the Haitian community is unwavering.”

A strong dedication to providing regular care brings Marshall back to Haiti four times a year and Bracken twice a year along with other volunteers from Mille Lacs Hospital. The community of Mille Lacs also contributes to the trips that occur every three months, with the Mille Lacs Health

System donating all medication, the Girl Scouts making gifts for the children, local churches donating clothing and shoes, and Lion’s Clubs gathering donations of eye-glasses. Marshall started the Santo Clinic organization to raise funds for their work in Haiti.

In an effort to reach more people, pop-up clinics are set up in churches in the rural areas, plus they make house calls to homebound patients. With the help of translators, the volunteer providers can see up to 140 patients a day. They conduct general exams, and treat people with parasites or infections and chronic ailments. In 2014, they brought and

placed 100 mosquito nets in homes in an effort to prevent dengue, malaria, and chi-kungunya. Bracken said, “Haiti is a place where you can actually make a difference. It is reassuring to see the same families when we come back. We have learned to trust each other.”


2016 COMMUNITY CAREGIVERS

Our desire to provide medical services to the Haitian community is unwavering.

Katherine Clinch, MDTwin Cities Anesthesia Associates

Dr. Katherine Clinch volunteers by providing anesthesia for the sur-gical repair of cleft lip and palate

deformities in China and Peru. According to Clinch, an anesthesiologist at Twin

Cities Anesthesia Associates, “My passion lies in pediatrics, so I look for oppor-tunities to work with children in my mission travels.” She generally spends one week in Peru through Programa San Francisco de Asis who focuses on cleft lip and palate repair and two weeks in China through Love Without Boundaries who helps orphaned and impoverished children. Now that both of her daughters are in college, Clinch wants to expand her volunteering and is looking at other international opportunities.

Clinch’s first mission trip to Zimbabwe was an incredible experience and she found the work addicting. Volunteering gives her

the unique perspective of seeing the world close up and the opportunity to meet people from different countries in a much more personal way.

At the beginning of a trip, Clinch works with both local and volunteer staff to set up a workflow for patients coming in for sur-

gery and for their care after the operation. She also assesses the anesthesia equipment and organizes the supplies. The team phy-sicians carefully screen potential patients by reviewing medical histories and any

available lab work. The medical teams work 12 to 14 hour days in order to complete as many surgeries as possible, and they often operate on 10 to 15 patients a day. The vari-ation and complexity of the defects deter-mines the complexity of the surgery and the anesthesia required.

Clinch advises other providers who may be thinking about volunteering abroad, to be aware of the environments they are going to be working in because that impacts the selection of patients. “A volunteer physician must be flexible and able to adapt to the environment,” noted Clinch. Tough decisions have to be made, and the team often decides against operating on young or under-weight children. The physicians have to consider whether a health care facility can care for a child after surgery once the volunteers have gone home or if the surgery is too risky. Saying no seems heartless, but teaching the family how to effectively feed the child in a way that allows them to gain weight despite their physical defects is better than risking

complications from the surgery. Her final advice to others, “Mission work is an in-credible opportunity and will change your life in the most positive way imaginable.”



A volunteer physician must be flexible and able to adapt to the environment.



Ayham Moty, MDHCMC Whittier Clinic

No matter where Dr. Ayham Moty ends up volunteering in the Philippines, hundreds

of patients are always lined up and waiting for medical care well before the physicians arrive. The patients either cannot afford medical care or do not have access to a medical fa-cility. The people have left a lasting impression on Moty, “The Filipino people are some of the most resil-ient people I have ever met. They remain positive through great hard-ship, natural disasters, and illness.”

Moty, a family physician, is med-ical director of HCMC’s Whittier Clinic in Minneapolis and a faculty member of the HCMC Family Medicine Residency Program. He offered his services to the Philippine Minnesotan Medical Association (PMMA) after hearing his colleagues talk about the need for medical support and services there. Every two years, the PMMA sends medical and dental teams to a dif-ferent part of the Philippines. Off years are spent raising funds and gathering supplies for the next trip. Moty wanted to volunteer

for a long time and finally did it with no regret. “I have been very blessed in my life and to be able to help those less fortunate is a true privilege.”

Moty provides primary care and also performs ambulatory surgical procedures where there is no need for general anesthe-sia or overnight observation. Many of these patients have not seen a medical provid-er for years and come in with advanced skin growths, subcutaneous tumors, and malignancies. He also provides primary medical care. A typical mission day in the Philippines starts at 5:30 a.m., with medical

procedures beginning at 7 a.m. and con-tinuing until 6 p.m. According to Moty, “It’s amazing that despite the long hours, you still feel energized after helping so

many people.”

In January 2016, he traveled with a team to Mariveles in Bataan, because the city did not have a hos-pital to meet the needs of a grow-ing population. The closest hospital was two hours away. There was a basic building structure in place, but it was not fully functional be-cause it lacked plumbing, electric-

ity, and furniture. PMMA sent an advance team of electricians, plumbers, medical facility experts, and other volunteers to Mariveles a week before the medical team arrived to get the building operational. Moty provided some insight to get the building up and running. The people and governor of Bataan were very appreciative for the help in completing a fully functional medical center.

Despite the long hours, you still feel energized after helping so many people.

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Betsy Schwartz,MD,MSPark Nicollet

Dr. Betsy Schwartz has been volun-teering since she was in high school when she walked dogs for The Hu-

mane Society. “As an environmentalist, my dad taught me to do whatever I can to make the world a better place,” said Schwartz, a pediatric endocrinologist at Park Nicol-let. She continued to volunteer while in college at two hospitals and during medical school as a tutor to inner city youth struggling in school. She wants to instill the importance of volunteering in her own children.

Schwartz volunteers for One Heart-land, a non-profit organization in Minnesota that runs summer camps for youth facing health challenges or social isolation. One Heartland runs Camp 5210 in Willow River, Minn., a camp for children who struggle with their weight. One Heartland approached Park Nicollet and HealthPartners seven years ago to help them develop Camp 5210 and its curriculum. Schwartz was part of that team and noted, “Through the years, we have learned what kinds of activities motivate the kids to make healthy changes.”

The camp staff includes physicians, di-eticians, health educators, physical ther-apists, and mental health providers and they provide social and emotional support for the campers. Kids help with vegetable gardening, meal planning, and food prepa-ration and stay active with lots of outdoor activities. She also teaches the campers and their parents about better eating habits and increasing their physical activity.

For the past 10 years, she has also volunteered for Camp Needlepoint, a camp for kids and teens with type 1 diabetes run by the American Diabetes Association. The camp is south of Hudson, Wis. on the St.

Croix River and has lots of activities such as tennis, basketball, swimming, sailing, and horseback riding to keep the kids busy. The campers benefit from the peer sup-port of other campers and counselors with diabetes. Schwartz works with doctors and nurses to manage the campers’ diabetes by reviewing blood glucose levels and insulin dosing, which allows the kids to concen-trate on having fun. Volunteer providers

also staff the health office where they care for typical camp-related health issues like bee stings, poison ivy, and homesickness.

Schwartz pointed out, “I enjoy being part of a team that creates positive experiences for children.” Working in the camps lets her promote health in a more creative, fun, and interactive way.

She discovered that her camp work has an unexpected bonus, “Volunteering gives me a different set of tools to use to motivate kids when I’m back in the clinic.”



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Shelly Strong, MDCentral Pediatrics

In 2010, after a number of teen suicides in Woodbury, Cottage Grove, and Still-water left these communities in shock,

Dr. Shelly Strong and Renee Penticoff knew they needed to do something. According to Strong, “We knew that somehow we need-ed to prevent suicides and help teens with mental health issues.” Strong, a pediatri-cian with Central Pediatrics and Penticoff, a psychologist in private practice, who have worked together for years, met to share their grief and thoughts about the rash of suicides. They decided to gather a group of professionals so they could work together to help at-risk teens. As a result, the Suicide Prevention Collaborative (SPC) was born.

The response was overwhelming as community mental health professionals, pediatricians, social workers, teachers, principals, school counselors, faith leaders,

and concerned parents all came togeth-er. “Collaboration is empowering and can make a difference right here in our community,” said Strong. The energy and determination of those who attended that first meeting set an action plan in motion that included forming several task forces to focus on resources, needs, and goals. As a first step, support groups were set up to help grieving students and a Facebook page was created.

SPC’s goal is to encourage schools, workplaces, and communities to make

mental health a priority. They want to educate the community to reduce the stigma of mental illness and teach them how to recognize and respond to the signs of a suicide crisis. They also want to reach teens who are at risk before they start having suicidal thoughts. “SPC is committed to increasing awareness about depression and other mental illnesses,” said Strong.

SPC sponsors a 5K race/fun run to raise money every year. The money is used to bring in well-known speakers to educate and raise suicide awareness in the community. SPC works to explore the impact that suicide has on a community and to inform people about area mental health resources and how to access them. The SPC also provides QPR training (question, persuade, and refer) to groups, which gives people the tools they need to talk about and confront suicide.

Strong said, “I see my work with SPC as an extension of my daily work as a pedi-atrician.” She feels that as teens learn to navigate through life, a healthy mind is im-portant. Strong and Penticoff both feel that encouraging people to talk about suicide goes a long way to saving lives.

Collaboration is empowering and can make a difference right here in our community.

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Pankaj Timsina, MDEssentia Health St. Mary’s– Detroit Lakes Clinic

Born and raised in Nepal, Dr. Pankaj Timsina has seen suffering, poverty, and pain firsthand. He consid-

ers himself fortunate that his family could afford health care and an educa-tion for him when he was growing up. The majority of people that he knew in Nepal, one of the poorest countries in the world, were not so lucky. “I have grown and achieved a lot during my short career, but my life will not be complete until I help those people and bring a smile to their faces,” said Timsina, a primary care physician, bariatrician, and hospitalist at Essentia Health St. Mary’s–Detroit Lakes Clinic. He is dedicated to helping those who cannot afford medical services and who have been deprived of basic health needs.

On April 25, 2015, a massive earthquake hit Nepal killing and injuring thousands of people. Timsina and his wife still have rel-atives living in Kathmandu and thankfully they were all safe. Timsina decided to drop everything, gather supplies, and fly to Nepal, along with Dr. Jared Aelony, to help earth-

quake victims. For two weeks, they treated thousands of injured victims and traveled to seven remote areas. They treated infections, broken bones, pneumonia, and gastroenteri-tis as well as chronic conditions that were not earthquake related. Timsina was there when the second earthquake hit on May 12,

which was quite scary. Timsina remembers his time in one village that was completely devastated, “A patient I treated who had lost her whole family in the quake gave me a small scarf as a token of appreciation. Her selflessness brought tears to my eyes.”

After returning from Nepal, Timsi-na and some of his friends started the ASK (Aspire to Serve with Kinship) Foundation dedicated to helping earth-quake victims in Nepal. ASK recently diversified its services and started op-erating a telemedicine program thanks to a team of physicians, software en-gineers, and people with an expertise in business. Timsina is in the process of setting up telemedicine clinics in five remote areas of Nepal. He is also conducting telemedicine training for both medical and non-medical person-nel in these remote areas and has set up online case forums for doctors to access specialists here.

Timsina tries to volunteer in Nepal once a year. He is planning on traveling to Ecuador and Guatemala next year to begin volunteering there. According to Timsina, “Life is too short and I want to make a dif-ference in people’s lives.”

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ELECTRONIC HEALTH RECORDS


The vast majority of health care insurance claims are processed electron-

ically. According to America’s Health Insurance Plans (AHIP), a trade organization that rep-resents the health insurance industry, fewer than 6 percent of all claims are adjudicated manually. For medical practic-es, there are many advantages to electronic claims submission:

• Electronic claims are paid more quickly; 93 percent of electronic claims are paid within 14 days, compared to just 79 percent of paper claims.

• There are fewer errors in claims submitted electron-ically due to the increased levels of editing and claims scrubbing protocols. Any errors are detected prior to submission, resulting in lower rejection rates.

• The number of claims re-quiring manual adjudication is significantly lower with electronic claims (47 percent

for paper claims vs. just 20 percent for electronic claims).

Of course, these advantag-es are small compared to the potential cost savings from electronic claims submission. According to a study by the California Association for Healthcare Quality, electronic claims cost just a fraction of their manual counterparts (see Table 1).

If your practice isn’t reaping the maximum benefits from

your electronic claims submis-sion policies, here are some common obstacles to overcome when streamlining the process.

Understanding your electronic claims submission needs

For many practices, the most important decision in the electronic claims submission process is whether or not to partner with a vendor. This begins with understanding your business needs and which tasks can be handled by in-house staff in a cost-effective man-ner, including EDI (electronic data interchange), revenue cycle management, and other services. These can only be assessed on a case-by-case basis. For example:

• Does your practice bill for multiple locations?

• Is there electronic claims ca-pability within your existing practice management soft-ware? If so, are there costs associated with implement-ing additional modules? Which formats and versions are supported?

• Do you participate in multi-ple networks and/or alterna-tive payment models?

• How important is it to complete other transactions electronically, such as ERA (electronic remittance ad-vice), eligibility, and claims status?

• What is the payer break-down? Does one carrier handle a large majority of claims?

• Do you have in-house staff available to reconcile and adjudicate electronic claims?

These questions will help you determine whether your practice is best served partner-ing with a claims vendor, and if so, evaluating individual pro-posals. Anthem, one of the larg-

est for-profit insurance carriers in the country, recommends asking the following questions before choosing an electronic claims vendor:

• Are fees assessed monthly or per claim?

• Will the vendor’s system work with your existing practice management software?

• Are mechanisms in place to ensure current versions of CPT (current procedur-al terminology), ICD-10, HCPCS (healthcare common procedural coding system), etc., are used and updated as appropriate?

• Is the vendor’s system HIPAA compliant?

• What editing, claim vali-dation, or claim scrubbing mechanisms are used? What is the claims rejection rate?

• What type of audit trails, reconciliation, and accounts receivable reporting are available?

• Does the vendor support electronic attachments?

Streamlining electronic claims

submissionsAvoiding the pitfalls

By Dipesh Patel and Courtney Willis

Table 1. Savings for manual vs. electronic claims

Manual Electronic Savings

Claims submission $2.58 54¢ $2.04

Claims payment $2.49 51¢ $1.98

Remittance advice $2.28 51¢ $1.77

Claim status inquiries $6.09 21¢ $5.81

Source: Smart Data Solutions

Assistant Professor The University of Minnesota Medical School Duluth invites applications for a full-time Assistant Professor (teaching track; non-tenured) in the Department of Family Medicine and Community Health Duluth. Candidates must have a M.D. or D.O. degree with Board Certification in Family Medicine or other primary care specialty, licensed or license eligible in Minnesota, with a minimum of 3 years of related clinical practice. Evidence of essential verbal and written communication skills, including clarity in the delivery of lectures, as well as evidence of medical student and/or resident teaching is required. Preference will be given to candidates in the Family Medicine Specialty with experience with collaborative relationships including work in team settings with other health care professionals. Experience with teaching in a variety of settings and formats, including lectures, small groups and clinical instruction and interest in or evidence of medical education research is preferred. Experience in curriculum development, innovative teaching and learning practices and grant writing is strongly desired.

For additional details regarding the position and to ensure consideration follow the application instructions online at: http://www1.umn.edu/ohr/employment/index/html (Job Opening ID #307392) Questions concerning the online application process should be directed to Linda Liskiewicz at [email protected].

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• Will any claims need to be submitted on paper? If so, how will the vendor handle them?

Ultimately, each practice will determine which submissions services best meets their needs, whether that is a clearinghouse, third party billing agency, or web-based submission service.

Avoiding common electronic claims pitfalls

After a period of fairly high denial rates in 2012 the Ameri-can Medical Association (AMA) reports that claims denials dropped nearly 50 percent in 2013 and 2014, to an average of just 1.82 percent overall. Not sur-prisingly, Medicare had the high-est claim denial rates, at nearly 5 percent, while Cigna reported the lowest, at 0.54 percent.

According to AMA research, the main issues affecting electronic claims fall into the following categories:

• Timely filing denials. Each payer has its own filing

schedules and timelines that must be followed; be sure policies are in place to file claims according to the payer’s guidelines.

• Nonspecific, incomplete, or incorrect coding. Failure to code to the highest level of specificity for a particular diagnosis is one of the top reasons for claims rejections or denials. Similarly, exclud-

ing a modifier for a proce-dure code, or choosing an invalid code (using a bilateral code on both sides instead of choosing the code for the cor-rect laterally) also rank near the top for rejected claims.

• Codes inconsistent with location where service is

provided. This occurs when inpatient codes are used with outpatient facilities and vice versa.

• Essential information omit-ted. This covers a multitude of errors, from something as simple as leaving off a prior authorization code to more significant omissions such as failing to submit documen-tation for medical necessity.

• Unbundling bundled ser-vices. Breaking out codes that should be bundled results in a significant percentage of denials. Using up-to-date NCCI (National Correct Coding Initiative) coding tables and payer-spe-cific guidelines eliminates this problem.

• Duplicate claims. This error occurs when practices sub-mit a duplicate claim for one that has not been paid, but is still active within the payer’s system.

A good electronic claims ven-dor will have built-in edits and powerful claim scrubbing proto-cols to catch the majority of these errors before claims reach the payers. Ask your prospective ven-dor partners which safeguards they use to prevent denials, and what processes are in place to adjudicate rejected claims.

Making the case for electronic attachments

AHIP estimates that about 80 percent of all claims were adju-dicated automatically; however, of the 20 percent that required additional information or manual intervention, a signif-icant percentage took 60 days or more to resolve. Given that manual adjudication is quite

There are fewer errors in claims submitted electronically.

Streamlining electronic claims submissions to page 36

Connecting your business to your market

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eases is a core public health

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ta Department of Health (MDH) has

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Vo lume X X IX , N o. 7

O c t ob e r 2015

What are patients and doctors to

make of the bevy of acronyms

that seem to increase daily?

HMO (health maintenance organization)

has been a commonplace set of initials,

as have HSAs (health savings accounts)

and PBM (pharmacy benefit manage-

ment). But now we have ACA (the Patient

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which may be easily confused with ACOs

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the ACA’s means of cost control.

So how did it happen that all of us are

now subject to the ACA, its ACOs, and an

alphabet soup of other acronyms, e.g.,

EHRs (electronic health records); P4P

(typically pay for “value” performance,

aka payment reform); FFS pay (fee-

for-service); or a threatening IPAB (the

federal Independent Payment Advisory

Board)? Recently, huge health insurance

corporation mega-mergers have been fea-

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and HMOs. What happened, what’s going

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malpractice

A look at medical costs

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Infectious disease

The value of physician reports

By Richard Danila, PhD, MPH, and Ruth Lynfield, MD

My colleagues at Park Dental

and I see dozens of patients

every day. While our focus is

on their mouths, we occasionally en-

counter other health-related issues that

require the attention of a physician.

Our dentists and hygienists routinely

take each patient’s blood pressure, per-

form oral cancer screenings, and look

for any other symptoms that might be

indicative of a larger health issue. If we

encounter any concerning medical is-

sues our dentists instruct their patients

to visit their physicians.

One of our dentists, Joseph F.

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currence. Dr. Rinaldi was scheduled to

remove a patient’s molar. Prior to the

surgery, the patient’s blood pressure

Leveraging information technology to page 18

Forging new alliances to page 16

Vo lum e X X IX , N o. 1

A p r i l 2015

Electronic health record (EHR) sys-

tems have become commonplace

in Minnesota’s health care sys-

tem, with most clinics and all hospitals

transitioning from paper charts to EHRs.

Despite this high adoption rate, provid-

ers are struggling to optimize the tools

and capabilities to support patient care,

and to exchange clinical health informa-

tion with providers outside of their own

health system.

In 2007, the Minnesota Legislature

passed the 2015 Interoperable EHR

Mandate, which states that all hospitals

and health care providers must use an

interoperable electronic health record

(EHR) system by Jan. 1, 2015 (Minne-

sota Statute § 62J.495 Electronic Health

Record Technology). An important com-

ponent of this law is that providers not

only adopt the technology, but that they

use the tools available in their EHRs and

securely exchange relevant health infor-

Leveraging

information

technology

A look at EHR data

By Bob Johnson, MPP, and

Karen Soderberg, MS

Forging new

The benefits of medical/dental collaboration

By John E. Gulon, DDS

alliances

FAMILY PRACTICE PHYSICIANS:

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costly, there is a strong case to be made for simplifying and automating the process.

In many cases, electronic attachments bridge the gap be-tween pending claims and man-ual adjudication. In the case of medical necessity, for example, which is required under NCDs (national coverage determina-tions) and LCDs (local coverage determinations) for many pro-cedures, appending the relevant documentation electronically can resolve these claims on the first pass. Considering that it takes a typical payer between two and four weeks to request supporting documentation, and another two to four weeks to manually return the infor-mation, automating the attach-ment process can trim 30 days or more from the receivables cycle on these claims.

What’s ahead?

When ICD-10 coding guidelines were implemented, the Centers for Medicare and Medicaid Services (CMS) were bracing for a 200 percent increase in claims rejections, and while denials increased somewhat above baseline, the worst pre-dictions were not realized. That does not mean, however, that the transition has been without consequences for revenue cycle management.

The most common issues reported were claims with both ICD-9 and ICD-10 codes on the same claim, resulting in clear-inghouse rejections, and incor-rect qualifiers, most frequently traced to improper settings in vendor software.

Best practices for ICD-10 include:

• Ensuring that codes and qualifiers match; both must be ICD-10.

• Updating policies for nation-al and local coverage deter-minations (NCDs and LCDs) that apply after the Oct. 1 ICD-10 deadline.

• Implementing safeguards to ensure that codes have the correct number of digits.

Even though CMS has indi-cated that providers will have some leeway the first year of the ICD-10 transition, private pay-ers are under no such obliga-tion. Be sure your billing staff and/or electronic claims vendor is up-to-date on specific payer guidelines.

With the rise in electron-ic claims submission and PPACA-mandated ERAs/EFT (electronic funds transfer), today’s health care practices are closer than ever to a paperless revenue cycle, which, when fully implemented, will result in con-siderable savings for providers. According to the Department of Health and Human Services, electronic payments, the logical companion to electronic claims submission, is expected to grow from 34 percent in 2010 to over 80 percent by the end of the de-cade. For the forward-looking medical practice, the transition to a virtually paperless revenue cycle management presents op-portunities for greater efficien-cies and reduced costs going forward.

Dipesh Patel is clearinghouse director at Smart Data Solutions, a company in St. Paul that offers document and transaction processing solutions. Courtney Willis is marketing manager at Smart Data Solutions.

Electronic claims are paid more quickly.

Streamlining electronic claims submissions from page 35

Family Medicine

Minnesota and WisconsinWe are actively recruiting exceptional board-certifi ed family medicine physicians to join our primary care teams in the Twin Cities (Minneapolis-St Paul) and Central Minnesota/Sartell, as well as western Wisconsin: Amery, Osceola and New Richmond.

All of these positions are full-time working a 4 or 4.5 day, Monday – Friday clinic schedule. Our Minnesota opportunities are family medicine, no OB, outpatient and based in a large metropolitan area and surrounding suburbs.

Our Wisconsin opportunities offer with or without obstetrics options, and include hospital call and rounding responsibilities. These positions are based in beautiful growing rural communities offering you a more traditional practice, and all are within an hours’ drive of the Twin Cities and a major airport.

HealthPartners continues to receive nationally recognized clinical performance and quality awards. We offer a competitive salary and benefi ts package, paid malpractice and a commitment to providing exceptional patient-centered care. Apply online at healthpartners.com/careers or contact [email protected], 952-883-5453, toll-free: 800-472-4695. EOE

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You focus on taking care of patients.We’ll take care of the rest.

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www.acmc.com |

FOR MORE INFORMATION:

Kari Lenz, Physician Recruitment | [email protected] | (320) 231-6366

Affiliated Community Medical Centers is a physician owned multispecialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties:

• Dermatology• ENT• Family Medicine• Gastroenterology• General Surgery• Geriatrician• Outpatient

Internal Medicine

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

• Psychiatry• Psychology• Pulmonary/

Critical Care• Rheumatology• Sleep Medicine• Urgent Care

Contact: Todd Bymark, [email protected](218) 546-3023 | www.cuyunamed.org

Cuyuna Regional Medical Center is seeking two full-time Family Medicine physicians for its Crosby Clinic. Located in the heart of the Cuyuna Lakes Area, CRMC’s Crosby clinic has recruited 22 New and dedicated, quality physicians & APC’s in the last 2 ½ years that, along with the required up-to-date technology, have developed CRMC into a regional resource for advanced diagnostic and therapeutic healthcare services. Our Family Medicine opportunity:• MD or DO• Board Certified/Eligble in Family Medicine, Internal Medicine or IM/Peds• Full-time position equaling 36 patient contact hours per week• Work 4.5 days a week.• 1 in 11 Peds call. (Majority of calls handled by phone consultation) • Practice supported by 14 FM colleagues, APC’s and over 35 multi-specialty physicians• Subspecialty providers—Internal Medicine, OB/GYN, Orthopedics, Urology, Surgery, Oncology, Pain Management and more• Competitive comp package, generous signing bonus, relocation and full benefits • New Residients are encouraged to apply

A physician-led organization, CRMC has grown by more than 40 percent in the past three years and is proudly offering some procedures that are not done elsewhere in the nation. The Medical Center’s unique brand of personalized care is characterized by a record of sustained strength and steady growth reflected by an ever-increasing range of services offered.

EmploymentOpportunity Clinic Administrator Orthopaedic Associates of Duluth, P.A. is a physician-owned,

highly reputable, well established clinic with ten physicians, eight

physician assistants, and nine physical and occupational therapists.

We are seeking an experienced Clinic Administrator to provide

strategic and operational leadership for the medical practice within

our three northern MN locations. The position is responsible for

overall financial and operational management of the daily activities

including operations, accounting, medical and business information

systems, marketing/public relations, personnel administration,

and planning and development. The selected candidate will have

superior management, interpersonal, and analytical skills and be a

strong communicator. Must have a solid financial background and

be comfortable in a clinic environment. The position continually

monitors operations as well as corporate compliance, HIPAA, risk

management, and patient satisfaction. Represents the clinic in

its relationships with other healthcare organizations, government

agencies, and third party payers. The Administrator is accountable

to the physicians. Bachelors degree with 7-10+ years of experience

in physician practice management required. Position offers a

competitive salary and excellent benefits package.

Email resume to [email protected] orfax to attn: Marisa 218-722-6515.

A breakthrough in heart failure treatment from page 23


with Preserved Ejection Fraction (PARAMOUNT) trial compared LCZ696 with valsartan and found that LCZ696 reduced measured NT-proBNP levels to a greater extent than valsartan (Solomon et al., 2012). Addition-ally, there were also beneficial findings of reduction in left atrial volume index with LCZ696 compared to valsartan, which suggests improvement in cardiac remodeling. The Prospective Comparison of ARNI with ARB on Management of Heart Failure with Preserved Ejection Fraction (PARAGON) trial is an ongoing study evaluating the clinical outcomes of mortality and hos-pitalizations when comparing LCZ696 with valsartan.

Chronic kidney diseaseAnother area of active

research includes the role of Neprilysin inhibition in chron-ic kidney disease. LCZ696 has been found to have beneficial renal preservation effects when studied in a heart failure

population (Voors et al., 2015). Additionally, it has been sug-gested that the beneficial renal effects of Neprilysin inhibition is due to renal natriuretic pep-tide effects, as a combination of endogenous natriuretic peptides with omapatrilat enhanced renal function (Chen et al., 2001). LCZ696 is being increas-ingly studied in those with chronic kidney disease (Judge et al., 2015). The ongoing UK Heart and Renal Protection III (UKHARP III) study seeks to compare LCZ696 with an ARB, irbesartan, in those patients with proteinuric renal disease to assess any differences in glo-merular filtration rate change.

Prevention of development of heart failure

There are questions re-garding the use of ARNI for the prevention of heart failure development, such as for Stage A and B heart failure, as well as those with minimal symptoms, such as in NYHA Class I. The St. Vincent’s Screening To Prevent Heart Failure (STOP-HF) study

suggested that screening with BNP levels in those at risk of symptomatic heart failure may lead to better outcomes (Led-widge et al., 2013). There is a high incidence of progression of preclinical systolic dysfunction or preclinical diastolic dysfunc-tion to symptomatic Stage C heart failure, with a major target for prevention being treatment of cardiovascular and systemic comorbidities (Wan, Vogel, & Chen, 2014). Therefore, target-ing detrimental neurohormonal pathways, such as with LCZ696, is an area of important research.

Potential concern about ARNIThere are also concerns

regarding dementia and Alz-heimer’s disease among those taking LCZ696, given that in-hibition of Neprilysin may also inhibit degradation of amyloid (Vodovar et al., 2015). A recent study in 2015 by Langenickel et al. has shown that LCZ696 does not increase cerebrospinal fluid levels of amyloid beta pro-teins. Further studies will need to analyze if and how much

LCZ696 crosses the blood brain barrier. Challenges of research-ing dementia outcomes in the heart failure population include the relatively lacking long-term data for LCZ696 at this time as well as the confounding variable of age-related cognitive decline.

Conclusion

The approval of a new heart failure therapy utilizing the Neprilysin inhibition mech-anism has been rooted in decades of physiology and clini-cal research. Emerging through many challenges, including the failed approval of omapatrilat, LCZ696 represents a new age of heart failure therapy. However, there remain many unanswered questions and promises for future research.

Siu-Hin Wan, MD, is a fellow and clinician investigator in the cardiac division at Mayo Clinic. Horng H. Chen, MD, BCh, is professor of medi-cine in the cardiovascular division at Mayo Clinic.

He needs you.

North Memorial is hiring MDs, NPs and PA-Cs.We are a fiercely independent, physician-led organization. Our physician leaders, including our CEO, and VPs see patients every week. Healing defines us. Not bureaucracy. We treat our patients and our employees better. We’re committed to ensuring our providers have fulfilling clinical work, competitive salary and benefits, and work-life balance. Interested applicants may contact:

Robert McDonald, MD Medical Director, Primary Care [email protected]

Todd Gengerke, MD Medical Director, Urgent Care and Convenient Care [email protected]

FAMILY PRACTICE PHYSICIANS:

What if work was where you went to recharge?

MARATHON HEALTH IS AN EQUAL OPPORTUNITY EMPLOYER

Do you know what it feels like to work with a sense of purpose? At Marathon Health, we’re on a mission to put “health” back in healthcare. We have partnered with Cargill’s turkey and cooked meats business in Albert Lea, MN and are looking for a part-time Family Practice Physician to work with employees and their families (newborns +). This is an onsite position, working either four hours per week or two days per month (total:16 hours per month) with a clinical team consisting of a Family Nurse Practitioner and a Medical Assistant. There are no on-call hours. Our intention is to provide the best patient care in a collaborative clinical community, and to give access to the workforce population in and around Albert Lea. Imagine – work could be the highlight of your day. For a more detailed job description and to apply online, please visit www.marathon-health.com.


Sioux Falls VA Health Care System

(605) 333-6852 www.siouxfalls.va.govApply online at www.USAJOBS.gov

Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package.

The VAHCS is currently recruiting for the following healthcare positions:

Cardiologist

Endocrinologist

ENT (part-time)

Emergency Medicine

Gastroenterologist

Hospitalist

Oncologist

Orthopedic Surgeon

Psychiatrist

Pulmonologist

Rheumatologist (part-time)

Urologist (part-time)

Family Medicine & Emergency Medicine Physicians

• ImmediateOpenings• Casualweekendoreveningshiftcoverage• Setyourownhours• Competitiverates• PaidMalpractice

Great Opportunities

763-682-5906|[email protected]

www.whitesellmedstaff.com

www.olmstedmedicalcenter.org

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

Opportunities available in the following specialties:

Send CV to: Olmsted Medical CenterHuman Resources/Clinician Recruitment 210 Ninth Street SE, Rochester, MN 55904

email: [email protected] • Phone: 507.529.6748 • Fax: 507.529.6622

AnesthesiologistHospital

ENTRochester

Southeast Clinic

General SurgeryHospital

Plastic SurgeryOMC Hospital –

Women’s Health Pavilion

PsychiatristRochester Southeast Clinic

Psychiatrist – Child & Adolescence

Rochester Southeast Clinic

Psychology–AdultRochester Southeast Clinic

Sleep MedicineRochester Northwest Clinic

UrologyHospital


These findings provide strong rationale, from both a value and an equity perspective, to expand access to doula support, espe-cially among those communities at greatest risk of preterm birth and poor birth outcomes. But it will take more than a change in the law to ensure access to doula support for Minnesota’s most vulnerable women.

How physicians can increase access to doula supportIn Minnesota, we are fortunate to have statutory language supporting Medicaid cover-age of doula services, but the law’s full potential has yet to be realized. Over the past two years, we have led a research project to study the early implementation of Minnesota’s legislation, gathering perspec-tives from pregnant Medicaid beneficiaries, doulas from communities of color, doula program administrators, and managed care organizations. In December 2015, we published a

report describing the first year of implementation of Minneso-ta’s Medicaid coverage of doula services, during which time only a handful of doulas had been reimbursed by Medicaid for services rendered.

While early implementation has been slow, Minnesota’s physicians are in an excellent position to help improve access to doula services among their patients and in the communi-ties that stand to benefit most. In our study of the rollout of Medicaid reimbursement for doulas in Minnesota, we identi-fied several major barriers and challenges that are relevant for Minnesota physicians who care for patients before and during pregnancy.

EducationFirst, a major challenge is the simple lack of awareness of doula coverage among Med-icaid beneficiaries, maternity care clinicians, and health-care delivery systems. Physicians can help by learning what a

doula is and how to work with one, and sharing information with patients about the role of a doula. Physicians can also work with local doula organizations to help their patients connect directly with doulas and other supportive resources. In addi-tion, physicians can educate colleagues, including nurses, staff, and administrators, within the health-care delivery system about the role doulas play and about Minnesota’s Medicaid payment policy for doula services. Finally, phy-sicians can serve as allies for women from communities of color by educating themselves about the current and histor-ical challenges faced, in par-ticular, by African-American and American Indian women during pregnancy and birth. Our interviews with pregnant women and with doulas of color revealed the important role doulas play as “cultural bro-kers” in patient-provider com-munication during pregnancy and birth. Working together, doulas and clinical teams have the skills to address a wide range of patient needs: emo-tional, informational, physical, psychological, social, clinical, and cultural.

CollaborationSecond, physicians can improve patient access to doula care by formal and informal collabo-ration with doulas, including those who provide support for Medicaid beneficiaries. Cur-rently, in order for doulas to be reimbursed by Minnesota’s Medicaid program, doula ser-vices must be provided under the supervision of a licensed cli-nician and billed through that clinician’s National Provider Identification (NPI) number. Creating these structures has been challenging for doulas and maternity care clinicians, even in hospital-based programs that employ doulas. In addition to establishing formal collabora-tions to enable billing and pay-ment, physicians can also col-laborate informally with doulas by connecting with local doula groups and referring patients to these services. However, doulas serving Medicaid beneficiaries cannot receive payment without

a formal partnership in place, and doulas are in need of more physician colleagues who are willing and able to collaborate for the purposes of billing. There are several communi-ty-based doula organizations across the state that offer cul-turally-informed doula services to Medicaid beneficiaries in Minnesota. These include Aha-vah BirthWorks (North Minne-apolis and Twin Cities metro area), Mewinzha Ondaadiziike Wiigaming (Red Lake, Leech Lake, and Bemidji area), and Everyday Miracles (Twin Cities metro area and Duluth metro area). Other individual doula providers are listed online in the Minnesota Doula Registry.

While disparities in birth outcomes are a tragic reality in too many Minnesota fam-ilies and communities, physi-cians can play a role in efforts to address these disparities, including supporting access to doula care for their patients and for vulnerable communi-ties. Informed physicians are a powerful force for improving access to doula care for preg-nant Medicaid patients and all of Minnesota’s mothers. Doula care supports better patient engagement, improved birth outcomes, and higher maternal satisfaction with care during pregnancy and birth. Our new research findings, taken togeth-er with the known barriers to implementation of Minnesota’s Medicaid coverage policy, may provide an impetus for physi-cian involvement in efforts to reduce disparities in birth out-comes in Minnesota by increas-ing access to doula support, especially among women who stand to benefit most.

Katy B. Kozhimannil, PhD, MPA, is associate professor in the Division of Health Policy and Management at the University of Minnesota School of Public Health. Rachel R. Hardeman, PhD, MPH, is assistant professor in the Division of Health Care Policy & Research at Mayo Clinic, Division of Healthcare Policy & Research. Jennifer Almanza, BAN, RN, PHN, is a clinical instructor and doctoral candi-date in the Child and Family Health Cooperative Unit at the University of Minnesota School of Nursing.

Doula-assisted birth from page 25

OPEN POSITIONS INCLUDE: n Cardiologyn Dermatologyn Emergency Medicinen Family Medicine

n OB/GYNn Orthopedics

(Adult & Pediatric) n Rheumatology EOE/M/F/Vet/Disabled

Physician OpportunitiesEssentia Health delivers on its promise to be “Here With You” and is guided by the values of quality, hospitality, respect, justice, stewardship and teamwork.

PLEASE CONTACT800-882-7310 | www.essentiahealth.org/careers


Opportunities for full-time and part-time staffare available in the following positions:

US Citizenship required or candidates must have proper authorization to work in the U.S. Physician applicants should be BE/BE. Education Debt Reduction Program funding may be authorized for the health professional education that was required of the position. Possible

recruitment bonus. EEO Employer.

Competitive salary and benefits with recruitment/ relocation incentive and performance pay possible.

For more information:Visit www.USAJobs.gov or contact

Nola Mattson, [email protected] Resources

4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301

• Associate Chief of Staff, Primary Care

• Dermatologist

• Internal Medicine/ Family Practice

• Occupational Health/Compensation & Pension Physician

• Physician (Compensation & Pension)

• Physician (Pain Clinic)/Outpatient Primary Care

• Psychiatrist

Applicants must be BE/BC.

St. Cloud VAHealth Care SystemBrainerd | Montevideo | Alexandria

Fairview Health Services seeks physicians with an unwavering focus on delivering the best clinical care and a passion for providing outstanding patient experience.

We currently have opportunities in the following areas:

• Allergy/Immunology• Dermatology• Emergency Medicine• Family Medicine• General Surgery• Geriatric Medicine• Hospitalist• Internal Medicine• Med/Peds

• Neurology• OB/GYN• Orthopedic Surgery• Pain Medicine• Palliative Care• Pediatrics• Psychiatry• Pulmonary Medicine• Urology

BEYOND TREATING,THERE’S CARINGW E L L A N D B E Y O N D

Sorry, no J1 opportunities.

fairview.org/physicians TTY 612-672-7300EEO/AA Employer

To learn more, visit fairview.org/physicians, call 800-842-6469 or email [email protected]

Send CV to: [email protected] ext. 108 • www.raiterclinic.com

417 Skyline Blvd. • Cloquet, MN 55720

Our independent, physician-owned clinic is seeking a BC/BE physician (with or without OB) for our clinic.

1:7 Calls. Competitive salary/benefits, with opportunity for ownership within 1 year. Paid malpractice, health and dental

insurance, 401(k), CME and more. Cloquet is an historic, vibrant community just 15 minutes from Duluth and 10 minutes from Jay Cooke State Park. Adjacent to the St. Louis River, Cloquet has hiking, biking and ATV trails; skiing; boating; fishing; parks; and the only white water rafting in Minnesota. Residents enjoy locally performed

plays, concerts and the arts; community festivals; dining and more.

Family Medicinewith or without OB

It’s your life. Live it well.

evolving practice model. With patient-centered care and a foundation of mutual respect and trust among providers, patients benefit from a shared commitment to improved outcomes. At the same time, complex health con-ditions and complex health delivery systems require recognition of the limits of individual professional expertise and the need for cooperation and coordina-tion across professions to effectively and efficiently provide care within core competencies. As noted in a 2011 report on Core Competencies for Interprofes-sional Collaborative Practice, it is essential that health care pro-fessionals recognize the extent and limits of unique expertise, culture of the health delivery system, power differential, and hierarchy within interprofes-sional teams to effectively com-municate, engage in conflict

resolution, and positively contribute to interprofessional relationships (Interprofessional Education Collaborative Expert Panel [2011]. Core competencies for interprofessional collabora-tive practice: Report of an expert

panel. Washington, D.C.: Inter-professional Education Col-laborative). Within the model of interprofessional practice, regulators should be expected to share the responsibility for public protection. The full report on Core Competencies for Interprofessional Collab-orative Practice is retrievable

online at http://www.aacn.nche.edu/education-resources/ipecreport.pdf.

Minnesota’s Tri-Regulatory Boards accept this shared responsibility with educators and interprofessional teams.

The Boards’ objectives include forging interdependent rela-tionships among the Boards to improve public health, welfare, and safety, and receptiveness to ideas that recognize the mul-tidisciplinary nature of health delivery systems. Through interregulatory collaboration, engagement with external stakeholders, and participation

in joint initiatives, the Minneso-ta Tri-Regulatory Boards con-tinue to contribute to improved patient outcomes through shared responsibility for public protection.

Ruth Martinez, MA, is execu-tive director of the Minnesota Board of Medical Practice. She has a long career in public service and has been with the Board since 1988, including 12 years as supervisor of the Board’s Complaint Review Unit. Shirley A. Brekken, MS, RN, has been the executive director for the Minnesota Board of Nursing since 1999. She currently serves as the

president of the Board of Directors for the National Council of State Boards of Nursing. Cody Wiberg, PharmD, MS, RPh, is executive director of the Minnesota Board of Pharmacy. He is also a clinical assistant professor for the University of Minnesota College of Pharmacy, and an instructor and course director at the University of Florida Graduate School.

Regulators should be expected to share the responsibility for

public protection.


The Minnesota Tri-Regulator Collaborative from page 17

The source for Diamondhead Property

� Custom homes � Lake view, golf course views, � Lake front, Vista views or Interior lots

� Rental programs available � Live in or use as nightly rental Income

We offer a wide range of outstanding real estate investment and/or retirement opportunities. Build-able lots start as low as $10,000 with many options ranging to new 5-bedroom 4,000 SQ FT lakefront homes for $490,000.

A glittering jewel of a community on the shores of Lake Catherine and with the panorama of the Ouachita Mountain range, Diamondhead Resorts 2,300 acres are known as a golfer’s paradise and a fisherman’s dream. Our temperate year-round climate will be welcomed by all Minnesotans.

Hot Springs National Park unparalleled value, quality of life and natural beauty

1-800-599-7249www.diamondheadcommunity.net

www.seediamondhead.com

101 Catherine Park Rd., Hot Springs National Park, AR 71913


BIGFORK, MN • COOK, MN

Located throughout beautiful Northern Minnesota, Scenic Rivers Health Services is a provider-driven not-for-profit organization. Currently, we are seeking a Family Practice Physician at our location in Cook, MN. This position focuses on local family healthcare, in a well- established modern facility helping to support our growing patient needs. You will quickly develop a gratifying panel of patients. Participation in on-call schedule, inpatient and after- hours care is shared (no OB), BC/BE and current or eligible for MN license required.

Work – Life Balance:

Northern MinnesotaPhysician Opportunities

•4 day work weeks•Significant starting and residency bonuses •Competitivesalaries•Fullbenefitpackage•20vacationdays•12sickdays•10CMEdays•6holidays•3personaldays

SCENiC RivERS HEaLTH SERviCES

Ski, hike, run, fish, canoe, kayak, camp, or hunt in your own

backyard or in the Boundary Water

Canoe Area, Voyageur’s National Park, Superior

National Forest and countless State Parks

For more information or to send a resume:

Cook Area Health Services, Inc. Travis Luedke20 5th St. SE, Cook, MN 55723 | [email protected] | 218-361-3190

National Health Service Corps Loan Repayment Potential

Eric Scrivner, MD

ScenicRivers_0615.indd 1 6/10/15 11:33 AM

NOVEMBER 2015 MINNESOTA PHYSICIAN 44

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Documents

Mn Physician Apr 2016