mn physician mar 2016

Health care providers have been working with shared savings in one form or anoth-

er for many years. As the concept has matured it has moved from the day of managed care and capitation to the accountable care organization (ACO) contracts and the total cost of care contracts now common.

Integrity Health Network (IHN) believes that to be part of the solution to this country’s health care woes we

need to be different, developing new models and ways to deliver health care. We believe in clinical integration and sharing financial risks and re-wards across our network to enhance independent medicine. The Integri-ty Health Foundation, an affiliated 501(c)3 non-profit organization, has also made investments in indepen-dent medicine’s future—including the 2014 launch of our Medicare Shared

Minnesota Medicaid ACO initiative to page 18

Making an ACO work to page 16

Vo lum e X X IX , N o. 12M ar c h 2016

In her position in pediatrics at Hennepin County Medical Center, community health worker Monica Aidoo-Abrahams represents

one of the most promising emerging fields in health care. Her role is to guide people of many different backgrounds—children and families from minority and immigrant communities—as they navigate their way through the complex health care system. The funds are there to pay for her position thanks in part to a ground-breaking initiative in Minnesota’s Medicaid pro-gram called the Integrated Health Partnerships (IHP). According to Aidoo-Abrahams, “Patients need help and support to navigate the health care system.”

Improving quality of careStarted by the Minnesota Department of Human Services (DHS) in 2013, the IHP creates incentives for providers to improve the quality of care for patients, while also reducing costs. One of the best ways to do that is to improve care coordination, and that’s why emerging pro-fessions such as community health workers and community paramedics are important.

Minnesota Medicaid ACO

initiativeIntegrated Health Partnerships

By Nathan Moracco

Making an ACO workSigns of success

By Bruce Penner, RN, and Jeffrey L. Tucker

Medication PAMade Easy

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THE ONLY ALL PAYER, ALL MEDICATION ELECTRONIC PRIOR AUTHORIZATION NETWORK

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FEATURES

MARCH 2016 MINNESOTA PHYSICIAN 3

MARCH 2016 • VOLUME XXIX, NUMBER 12

www.mppub.com

PUBLISHER Mike Starnes | [email protected]

EDITOR Lisa McGowan | [email protected]

ASSOCIATE EDITOR Richard Ericson | [email protected]

ART DIRECTOR Joe Pfahl | [email protected]

OFFICE ADMINISTRATOR Amanda Marlow | [email protected]

ADVERTISING Stacey Bush | [email protected]

DEPARTMENTS

Breaking bad news 28By Kathleen Kieran, MD, MS

Maximizing Medicare 24 payments

By Candy Hanson, BSN, PHN

Health literacy 26By Mick Hawton

CAPSULES 10

MEDICUS 13

INTERVIEW 14

ELECTRONIC HEALTH RECORDS 20The Electronic Prior Authorization Mandate

By Perry Lewis

CARDIOLOGY 22Radial access

By Carmelo J. Panetta, MD

HEALTH DISPARITIES 30East African culture and mental health

By Ahmed M. Hassan, MA, LPCC

MEDICINE AND THE LAW 32Intellectual property in medicine

By Sean Solberg, JD

Making an ACO work 1Signs of successBy Bruce Penner, RN, and Jeffrey L. Tucker

Minnesota Medicaid 1 ACO initiative Integrated Health PartnershipsBy Nathan Moracco

A new ecosystem for health

Douglas L. Wood, MD, FACP, FACC

Center for Innovation at Mayo Clinic

PROFESSIONAL UPDATE: MEDICAL ETHICS

SPECIAL FOCUS: OUTCOME-DRIVEN REIMBURSEMENT

Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email [email protected]. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to re-place medical, legal, tax, business, or other professional advice and counsel. No part of the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.

Medical Innovation vs.

Medical EconomicsMedical EcconomicsWhen payment policies

limit quality of life

Background and Focus: The pace of innovation in medical science is rapidly escalating. From more accurate diagnostic equipment, to the use of genomic data, to better surgical techniques and medical devices, to new and more efficacious pharmaceuticals, breakthroughs occur nearly every day. These advances face many challenges when incorporated into medical practice. Several significant factors limit this adoption, including the economic models around how patient use of new science will be utilized. Twentieth century health insurance, medical risk management, and reimbursement models are controlling 21st century medical care and patients are the losers.

Objectives: We will review examples of recent scientific advances and the difficulties they face when becoming part of best medical practice, despite their clear superiority over existing norms. We will look at prevailing thinking behind economic models that govern how health care is paid for today. Our panel of industry experts will explore potential solutions to these problems. We will look at ways to create balance between payment models, new technology, and increased quality of life.Panelists include: • Hamid R. Abbasi, MD, PhD, FACS, FAANS; Board Certified

Neurosurgeon, Tristate Brain and Spine Institute • John English, MD; PrimaCare Direct • Susan McClernon, PhD; Faculty Director, U of M Health Services

Management ProgramSponsors include: Tristate Brain and Spine Institute

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Thursday, April 21, 2016 • 1:00-4:00 PMThe Gallery (lobby level), Downtown Minneapolis Hilton and Towers

FORTY-FIFTH SESSION

MINNESOTA HEALTH CARE ROUNDTABLE

4 MINNESOTA PHYSICIAN MARCH 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

n A1

C ch

ange

from

bas

elin

e (%

)

• 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

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%)





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

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

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

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

-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.


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


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, USA

US License Number 1891

Copyright © 2014, 2015, Eli Lilly and Company. All rights reserved.

Additional information can be found at www.trulicity.com

DG HCP BS 20APR2015


CAPSULES

Minnesota Makes Progress on Some Adverse Health EventsThere were a total of 316 adverse health events reported to the Minnesota Department of Health (MDH) from October 2014 to October 2015, according to the department’s 12th annual Adverse Health Events report. That num-ber is up slightly from last year’s report, which showed 308 report-ed adverse health events.

Of the 316 reported events, 30 percent (93 cases) resulted in seri-ous injury and about 5 percent (13 cases) led to death. Both statistics were similar to last year’s report, which included 98 serious injuries and 13 deaths. The number of deaths associated with adverse health events has stayed steady over the last four years.

The most frequently reported adverse health events were pres-sure ulcers (104), falls associated with serious injury or death (67), and surgeries/invasive procedures performed on the wrong site/body part (29). There was an increase

in procedures done at the wrong spine level in this year’s report.

The type of event most likely to lead to serious patient harm or death was falls, with four of the 67 cases leading to death. Med-ication errors accounted for 14 cases (four of which led to death) and neonatal events accounted for seven cases (five of which led to death). Overall, in the 12 years the report has been published, the most common causes of serious harm or death have been falls, medication errors, and suicide/attempted suicide.

Improvements were made in the categories of falls and surgical errors related to a failure to remove all materials involved in the operation. The number of falls associated with serious injury or death declined to 67, the lowest ever reported, and the number of fall-related deaths is the lowest it has been since 2011. Those related to retained foreign objects from surgery declined to 22, also the lowest ever reported and a significant decrease from the previous year’s 33 cases.

“Although even one avoidable death or injury is too many, this year’s report shows the progress we are making, especially in

preventing falls,” said Ed Eh-linger, MD, Minnesota commis-sioner of health. “Our approach of openness and public reporting is helping to encourage overall improvements and new opportu-nities to protect patients.”

MDH and its partners will work to improve these statistics in 2016 by focusing on addressing prenatal safety; working with surgery and procedural teams to address full and accurate com-pletion of the Minnesota Time Out process for every patient every time; and implementing standardized processes for spec-imen collection and transport to prevent biological specimen loss or damage.

FDA Approves Medtronic’s MRI-Safe DefibrillatorMedtronic has received approval from the U.S. Food and Drug Administration to sell its implant-able resynchronization defibrilla-tor that’s safe to use around mag-netic resonance imaging (MRI) machines. The devices help treat

heart failure and reduce the risk of cardiac arrest while allowing patients access to MRI scans if and when they need them.

Previously, patients with a cardiac resynchronization ther-apy device (CRT-D) to treat heart failure could not undergo MRI scans due to a potential interac-tion between the MRI and the de-vice that could put them at risk.

As many as 40 percent of CRT patients will need an MRI scan within four years of receiving a device, according to Medtronic. Patients who use the new device will have access to MRI scans to help diagnose conditions such as stroke, cancer, and Alzheimer’s disease, as well as muscle, bone, and joint pain.

“What’s clear from the data and my own personal experi-ence is that a large majority of CRT-D patients will likely need an MRI at some point. Now that CRT-D MRI devices are approved, patients can receive an MRI in a straightforward manner,” said J. Rod Gimbel, MD, of Case Western Reserve University in Cleveland. “This is a significant development for heart failure patients with CRT-D therapy.”


is for Concierge.Online Check-In.Valet Parking.

U of M Opens New Patient-Centered Clinics and Surgery CenterThe University of Minnesota has opened a new $165 million Clinics and Surgery Center on the edge of its East Bank campus.

The 342,000-square-foot facility houses 37 specialties and 10 outpatient operating rooms. Many of the University of Minne-sota Medical Center outpatient clinics located in the Phil-lips-Wangensteen Building, Mayo Building, Masonic Memorial Building, and West Bank loca-tions moved into the new space to create a more collaborative care environment.

“The technology is state-of-the-art, the layout doesn’t feel like a clinic, and we expect patients will welcome this new approach to care delivery,” said Bobbi Daniels, MD, co-president of M Health. “Our world-class pro-viders and researchers now have a world-class space in which to serve their patients.”

The University of Minnesota is employing new methods at the center to decrease stress and

increase privacy for patients. A concierge with a tablet greets patients, reviews their appoint-ment information, gives them a real-time location-monitor-ing badge, and directs them to their appointment waiting area. Instead of calling out names for each patient, a nurse determines the patient’s location from their badge and escorts them to their exam room.

“There are little things during a clinic visit that cause stress or anxiety and our goal in build-ing this facility was to elimi-nate those triggers,” said Mary Johnson, CEO of M Health. “The personal interaction, convenient clinic arrangements, even the col-ors and artwork all enhance the patients’ experience and improve care delivery.”

A unique feature of the new Clinics and Surgery Center is its elimination of private offices for providers and administrative staff. Staff now share open workspac-es, with the intent of increasing collaboration on care delivery and increasing space efficiency. In addition, it houses a dedicated research liaison to discuss poten-tial clinical trials with patients that may be of interest to them as well as tablets located on each floor that

allow patients to search for clinical trials using an online search plat-form developed by the University of Minnesota’s Clinical and Transla-tional Science Institute.

“Often the barrier for patients is information about research and how patients can advance healthcare. We want to reduce those barriers,” said Brooks Jack-son, MD, dean of the University of Minnesota Medical School. “This facility is state of the art in both design and mission, and we’re blending clinical and research ef-forts to improve care and achieve breakthroughs.”

Three New Providers Join DHS’ Integrated Health Partnerships InitiativeThe Minnesota Department of Human Services (DHS) has an-nounced that three new provider groups have joined its Integrated Health Partnerships (IHP) initia-tive, a component of a $45 million federal State Innovation Model grant to drive health care reform in Minnesota. The IHP initiative now encompasses 19 provider

groups and more than 340,000 Medical Assistance enrollees.

The new provider groups are Allina Health, Gillette Chil-dren’s Specialty Healthcare, and Integrity Health Network. In addition, the six provider groups that helped launch the program in 2013 have all opted to continue in the IHP for another three-year cycle. North Memorial, one of the original participants, is expand-ing its participation to include its affiliate partners and clinics.

“Our nation-leading Integrat-ed Health Partnerships initiative shows that it’s possible to lower the cost of care while maintain-ing and improving quality of care for patients,” said Emily Johnson Piper, DHS commissioner. “It’s encouraging to see such strong interest from providers across Minnesota, both those who are joining and those who are continuing to participate in this initiative.”

The increased participation puts DHS on track to reach its goal of extending the IHP initia-tive and comparable value-based reforms to half of all Medical As-sistance enrollees (about 500,000 people) by the end of 2018.

Capsules to page 12


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Health Organizations Announce Action Plan to Improve Health Literacy in MinnesotaA coalition of health organiza-tions from across the state has released the Minnesota Action Plan to Improve Health Literacy to improve peoples’ abilities to obtain, understand, and act on health resources.

Nine out of 10 adults have difficulty understanding everyday health information, according to the U.S. Department of Educa-tion. Seniors, minority groups, and people with disabilities, low incomes, limited reading skills, or limited English proficiency are more likely to experience low health literacy.

To address this, a steering committee consisting of represen-tatives from the American Cancer Society Cancer Action Network, the American Health Association, Blue Cross and Blue Shield of Minnesota, the Minnesota Health Literacy Partnership, and Portico Healthnet led a six-month process

of engaging stakeholders across the state in conversations about barriers to and solutions to im-prove health literacy. Forty-three Minnesota health organizations, including insurers, providers, and patient advocacy groups, worked to develop the plan, which has identified six priorities.

These include: developing and implementing best practices for written and verbal health infor-mation to make it more under-standable by eliminating jargon; making health information easily accessible and presenting it in a variety of mediums; increasing and improving health care profes-sionals’ patient resources to make it easy to share in care services in person, by phone, or online; implementing and enhancing ed-ucation opportunities in primary, secondary, and professional edu-cation; streamlining processes in the health care system through partnerships to identify and implement strategies to lessen the burden on patients; and investing in language and cultural resourc-es to reach patients not proficient in the English language.

“As we worked together on this plan, it became clear that no

single action and no single entity can tackle the growing issue of health literacy,” said Meghan Kimmel, vice president for part-ner relations at Portico Healthnet. “Translating the strategies out-lined in this plan into meaningful action will require long-term commitments on the part of a broad range of stakeholders. We all need to work together to put this into action.”

All 43 participating health organizations have committed to implementing two to three strategies in the plan within their organizations. The groups will re-convene in October 2016, Health Literacy Month, to discuss next steps in implementation and ideas for further collaboration.

More Than 85,000 Sign Up for Private Coverage Through MNsureMNsure has surpassed its en-rollment goal for the first time after two years of falling short of expectations.

As of Feb. 1, 85,390 Minne-sotans enrolled in private health insurance coverage during the open enrollment period for 2016, beating MNsure’s goal of 83,000. About 23,000 more Minnesotans signed up for private health insur-ance through MNsure this year than in the 2015 open enrollment period. Among the private plan enrollees, 45 percent were new to the exchange— the highest num-ber of new enrollees nationwide, according to MNsure.

In addition, preliminary numbers show that 33,333 Minnesotans newly enrolled in MinnesotaCare; 73,173 newly en-rolled in Medical Assistance; and 7,144 Minnesotans enrolled in a dental-only plan.

About 2,000 signed up in the final weekend of MNsure open enrollment, with average wait times of about 10 minutes on the final day. Last year, wait times were as long as an hour on the final day of open enrollment.

“We are clearly making strong, steady progress,” said Allison O’Toole, CEO of MNsure. “That’s great news for thousands of Minnesota families.”

Capsules from page 11


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Vadim Gurvich, PhD, MBA, research associate professor of medicinal chemistry at the Univer-sity of Minnesota’s College of Pharmacy, has been named executive director of the National Institute for Pharmaceutical Technology and Education (NIPTE), a national consortium of leading schools and colleges of pharmacy and chemical engineering. Gurvich had served as associate director of NIPTE since the organi-zation’s inception in 2005. Gurvich earned a doctoral degree in organic chemistry at Hebrew University of Jerusalem in Israel; a master’s degree in chemical engineering at Mendeleyev University of Chemical Technology in Russia; and a master of business administration degree at the University of Kansas. He has more than 25 years of academic and industrial research and development experience.

Debra Peterson, MD, medical director for quality and patient safety and family medicine practitioner at Affiliated Community Medical Centers Litchfield clinic, has received the Min-nesota Medical Association’s (MMA) Physician Leadership in Quality Award in recognition of her work advancing quality and safety in health care. According to the MMA, Peterson was honored for putting evidence-based medicine into practice by establishing recommendations, workflows, and physician education to achieve

high quality outcomes. She earned her medical degree at the Uni-versity of Minnesota Medical School and completed her residency at the Center for Family Medicine in Sioux Falls, SD.

Rachelle Schultz, MHA, president and chief executive officer (CEO) of Winona Health, has been selected to serve as chair-elect of the 18-member governing council for the American Hospital Association’s (AHA) Section for Small or Rural Hospitals in 2016. She will assume the role of chair of the council in 2017. Schultz has more than 20 years of experience in health care management. At Winona Health, she oversees a 99-bed acute care hospital, physician clinics, a 134-bed nursing home, three assisted living residences, home care and hospice programs, retail pharmacies, a foundation, and related health care services. Schultz earned her master’s degree in healthcare administration at the Univer-sity of Minnesota. She serves on the Institute for Clinical Systems Improvement (ICSI) board, is a board director for the Minne-sota Hospital Association, and is a member of the Rural Health Issues Group, a collaborative of several governmental associations focused on rural health issues.

Kenneth Flowe, MD, chief medical officer of Rice Memorial Hospital in Willmar, has been selected to serve on the Centers for Medicare and Medicaid Services (CMS) Advisory Panel on Hospital Outpatient Payment. The 15-member panel will advise the secretary of the Depart-ment of Health and Human Services and the administrator of CMS on two key areas. In addition to serving as CMO at Rice Memorial Hospital, Flowe is also a practicing emergency physician and medical director of the hospi-

tal’s emergency department. He earned his medical degree from Wake Forest School of Medicine in Winston-Salem, NC, and his master of business administration degree from Duke University in Durham, NC.

Debra Peterson, MD

Kenneth Flowe, MD

Rachelle Schultz, MHA

Vadim Gurvich, PhD, MBA

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Douglas L. Wood, MD, FACP, FACC

Center for Innovation at Mayo Clinic

Dr. Wood is medical director of the Center for Innovation and a practicing cardiologist at Mayo Clinic. He previously served as vice-chair of the Department of Medicine, and chair of the Division of Health Care Policy and Research at Mayo. He served on the Gover-nor’s Health Care Reform Task Force and has been a leader in health reform in Minnesota. He has served on the Minnesota Citizens Forum on Health Care Costs and currently serves on advisory committees for medical home payment and provider peer grouping for the Minnesota Department of Health. He received the Distinguished Service Award from the American College of Cardiology, the Burgess Meredith Award from the American Medical Association, the Citation of Merit from the University of Missouri School of Medicine, and the Distin-guished Service Award from the MMA.

Please tell us what innovation means in health care.

Innovation is discovering and implementing solu-tions to improve health, and the care processes necessary to accomplish this. Health does not mean the absence of disease; instead, it means that a person can live their lives fully and unencumbered. Fundamentally, this means keeping people healthy so that they can meet the needs of those who rely on them, whether their role is that of a father, mother, son, or grandmother.

What are some of the challenges that innovation in health care faces?

The problem with innovation in health care is not due to a lack of advances in genetics, drugs, and devices, but in the lack of innovation in the delivery system itself. Successful innovation is significantly impeded by payment systems that focus on the number of visits, tests, and procedures. Our current emphasis on measuring processes of care and nar-row clinical outcomes has created a multi-billion dollar measurement industry that has lost sight of the need to improve health.

How is innovation in health care related to more than just technology?

Sometimes the solution is to use less technology and less “medicalization” of care, and to increase the human capacity to achieve health. We are all quite fascinated by wearable gadgets and apps for our phones, but the thing to keep in mind is that technology must make people’s lives better, more enjoyable, and easier.

What does a “new ecosystem” for health care mean?

We should actually use the term “ecosystem for health,” which means all the elements needed for people to achieve health. Health care is really just a small part of what it takes to be healthy. When talking about an ecosystem, we have to consider our communities, our home environment, and then think about how to structure education, social services, sustainable economic structures, transpor-tation, security, and safety, among other things. As for the health care system, it means thinking about health at home, at work, or at school and then inte-grating in aspects of public health, mental health, access to care, integration of care, affordability, insurance, technology, and infrastructure, which affects people and health care providers.

How will this new ecosystem happen?

The new ecosystem starts with a vision of what health should be, including all the determinants of health. An analysis of the gaps in our current system will identify the areas in which innovation is needed to make this new vision work. It should start with a deep understanding of what people

need, followed by a way to bring about accessible and affordable services within a system that is ca-pable of rapid, adaptive change.

In my view, this new ecosystem for health will be initiated and implemented by individuals and organizations outside of established medi-cal institutions in response to real and personal challenges. These changes will have to gain traction and connect with communities and markets. The resulting products and services could create a new network of resources or alter existing networks. Of course, success will depend on access, affordability, outcomes, and trust. Established medical institu-tions—such as Mayo Clinic—will need to remain relevant and identify their place and role within the new ecosystem. With these forces at play, the new ecosystem for health will thrive because it will be based on people’s actual needs.

How will the delivery of health care change?

We need to help people make better choices about their health and as a result, must move care to where people live and work. Every year, I see more individuals, entrepreneurs, and health care provid-ers, challenge assumptions, take risks, and make significant changes for the future of health. These isolated, independent actions that focus on improv-ing the well-being of family members, neighbors, and loved ones, are among the most positive signs I’ve seen for the future of health care.

These brave souls march forward out of frustra-tion with America’s health care system, because it is tied to an outdated, traditional medical model. The existing structure is too entrenched, and we find our country, for the most part, still burdened with skyrocketing pharmaceutical prices, shackled to reimbursement systems based on sickness care, and wrestling with rising insurance costs, despite the Affordable Care Act (ACA).

There is no question that we need a new model to achieve changes in health. Some of the most promising momentum I’ve experienced for the future of health and health care has come from a relatively small annual gathering of innovators and disruptors called the Transform conference, hosted by the Mayo Clinic Center for Innovation. Trans-form is a catalyst for engaging people to boldly cre-ate a sustainable future for health. In 2015, more than 700 attendees from 34 states and 15 countries with backgrounds as providers, administrators, re-searchers, designers, technologists, entrepreneurs, policy experts, and payers from more than 200 organizations participated in the three-day event.

What are your thoughts about the Affordable Care Act?

Right now there is not much in the ACA that creates affordability for people. It has helped to significantly reduce the number of Americans without access to insurance. But, if insurance is

INTERVIEW


too expensive, people are not really better off. Now that we have the access problem largely solved, we have to really focus on making health and health care affordable for everyone. Cost containment is important for families, businesses, and government.

What can physicians do to help create the new ecosystem for health?

Physicians have to begin by thinking about health first, and then what it means to truly understand people’s health needs. From there, physicians have to create care plans that focus on the goals that people have for their health rather than on narrowly-defined treatments or guidelines based solely on clinical measures or processes.

What can the consumer do to help create the new ecosystem for health?

People need to insist on having health, meaning the ability to live a meaningful, productive life without the burden of illness. This includes burdens imposed by physi-cians with prescriptions and proscriptions that are not relevant to a person’s goals for health. Here are three examples of individu-als who have made change possible:

At the 2015 Transform gathering, soft-ware developer John Costik talked about his son Evan, who was born with type 1

diabetes. As Evan got older, Costik became more anxious about the constant moni-toring required to maintain Evan’s blood sugar levels. Using his skills as a software engineer, he developed a remote blood glucose monitoring system, so parents can view their child’s glucose level while they are at school, at daycare, at a sleepover, or while playing sports. Now nearly two years later, this system serves the needs of 14,000 people. From an anxious dad’s need, a small grassroots revolution was born.

At that same event, entrepreneur Mario Schlosser discussed how he started an alternative insurance company called Oscar. Silicon Valley investors who wanted to make long-term revolutionary changes in health care funded this startup. Paying its first benefits in 2014, Oscar now claims 40,000 members, more than doubling the number

of members in the last open enrollment period in New York, one of the most com-petitive insurance markets in the country. Oscar will soon be offered in California and Texas as well.

Another example of someone improving health, is Dr. America Bracho, who cre-ated Latino Health Access in Santa Ana, California, to improve the health of those living at or near the poverty line. Latino Health Access trains local community health workers or “promotores” who go door-to-door to explain the importance of healthful eating, exercise, and preventive medical tests. Words of encouragement, delivered by trusted neighbors can break down barriers and open up avenues for improved health and lifestyles.

When can we expect to see this next model of health?

This new ecosystem is already starting to form. People and organizations are nat-urally gravitating toward resources and connections that work for them. Entrepre-neurs are already innovating in response to what truly benefits people. I hope we can see more changes like these within our health care system within the next two years. It will take longer for full realization however.

A multi-billion dollar measurement industry … has lost sight of the need

to improve health.


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Savings Program (MSSP) ACO. This program is a key compo-nent of the Medicare reform ini-tiatives included in the Afford-able Care Act. As an ACO, we are helping to drive a new approach to the delivery of health care—one that facilitates collaboration among providers to im-prove the quality of care for Medicare beneficiaries and reduce unnecessary costs.

By participating in the MSSP, we provide better care for individuals, im-prove the health of entire populations, and lower growth in expenditures for our members. The MSSP rewards ACOs that lower their growth in health care costs, while meeting performance standards on quality-of-care and patient experience.

Our ACO is comprised of six independent primary care clinics that came together to serve the minimum threshold

of 5,000 Medicare patients. Collectively, we are able to meet this minimum requirement and enjoy the benefits of the program; no single clinic in our network could have done so on its own. To help us navigate all

the Medicare regulations and compile the data necessary that allows us to effectively manage our Medicare population, we partner with Imperium Health Management, a leader in assist-ing physician-led ACOs.

To clear the path to ACO success, we are increasing the presence of Integrity staff

onsite at our clinics to review cost, quality, and utilization data. These reviews help members develop improved patient-engagement and popu-lation-management tactics. The methods and strategies devel-

oped for our ACO population are also applied to our other shared-savings contracts.

Lessons in data A major driving force behind any potential success is hav-ing timely, actionable data to present to our clinics, and more specifically, to the indi-vidual providers within each clinic. Providers are prone to react best to information that represents the patients they directly care for and less likely to react to clinic-level data. It has been important that data received from the Centers for Medicare & Medicaid Ser-vices (CMS) is organized into an understandable format and brought to the providers as soon as possible after we receive it. The more current or recent the data, the more it is trusted and the more effective corrective actions will be.

It is interesting to note that while we have made data avail-able via a web portal, most of our providers do not use this tool. When we hand deliver printed copies of their patient lists and claims information they immediately engage with the data. In almost every case, pro-viders also engage the resourc-es in their clinic to reach out to patients. This often includes collecting clinical data on their patients to augment the claims data. Bringing the claims and clinical data together gives them a power of knowledge and under-standing so they can improve the

care they give as well as the cost efficiency of that care.

Lessons in qualityCMS has structured the ACO process with the intent to create a balance between reducing

costs without sacrificing the quality of care deliv-ered. Through the group practice reporting option (GPRO), ACOs are required to submit data from which a quality score is calcu-lated. That score is then applied to the final calcula-tion for any shared savings that may be due the ACO. The higher the quality score the greater the per-centage of shared savings

paid to the ACO.

It’s interesting to note that the drivers that improve the quality score also increase the potential for savings. Since most of the GPRO measures are primary care based the program encourages more primary care visits and preven-tive services. Moreover, CMS has created some incentive and support for this by offering payment for transitional care management (TCM), annual wellness visits (AWV), and chronic care management (CCM). All of these provide the opportunity to improve patient outcomes and reduce overall costs through early intervention and prevention.

Within the GPRO measures is a subset of measures that are derived from the results of the Consumer Assessment of Healthcare Providers and Sys-tems (CAHPS) survey admin-istered each year. This survey measures the patients’ expe-rience in their primary care clinic. Because this is based solely on a patient’s perception it is important not only to per-form the services or address the issues that the survey assesses, but to do so in a manner that is memorable to the patient. The patient experience measures do not rely on documentation in the health record but on the patient’s recollection of their experience.

In short, it is our belief that considerable savings can occur


Making an ACO work from cover

Healthy patients are more likely to not

see their provider on a yearly basis.


as a secondary gain to provid-ing higher quality care in the primary care setting. This also results in fewer emergency department visits, fewer unnec-essary admissions, and lower specialty care costs.

Lessons in engagementPatient engagement has become one of the “buzz words” in health care over the past few years. Without increased patient involve-ment in the care process, provider efforts can only go so far in improving quality outcomes and reducing costs. TCM, AWV, and CCM all offer excellent opportunities to increase patient involvement in a meaningful way. They allow greater patient/clinic contact while improving health and cost outcomes.

From reviewing our data, we have also had to develop strategies to help assure that even the healthiest of patients have at least one primary care visit each year. Healthy

patients are more likely to not see their provider on a yearly basis. Improving the number of patients that have at least one visit each year not only provides the opportunity to accomplish

many of the quality improve-ment activities but also assures that patients will stay attributed to the ACO; a key strategy in maximizing potential savings earned. This also reinforces patient engagement by getting them and keeping them con-nected to their provider.

We have already discussed the value of provider-specific data to get and keep provid-ers engaged. This has become even more important in light of the fact that when we started

our ACO our initial costs were already low and our quality numbers were already relative-ly high. It would appear that there was little improvement opportunity. At first this was

actually a distraction; why work on getting better when we’re already so good! But when the providers saw information on their patients they immediate-ly spotted opportunities for improvement. They inevitably engaged at the appropriate level; where their expertise can affect positive change in their patients’ health and welfare and not just ACO-level numbers.

Another important level of engagement is the clinics them-selves. There have been both

operational and clinical para-digm shifts. Clinically there has been a reinforcement of and shift toward a more patient-cen-tered medical home (PCMH) model of care delivery. Regard-

less of certification, the concepts of patient centric-ity and team care delivery have been found to be both fruitful and rewarding.

Operationally, and to some degree clinically, there has been and con-tinues to be a retooling of EHR use and IT infrastruc-

ture to improve the collection of key data elements and the data extraction and report genera-tion abilities of EHRs.

The challengesThere are administrative bur-dens to operating an ACO, espe-cially a smaller organization like IHN. It can be quite a chal-lenge to operate in the Minne-sota marketplace, where more than 50 percent of seniors have enrolled in Medicare Advantage

Why work on getting better when we’re already so good!

Making an ACO work to page 41

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Minnesota became the first state to implement an account-able care organization (ACO) in its Medicaid program when it started the IHP program three years ago. If providers deliver care for less than mutually agreed upon targets for cost and quality, the IHP initiative allows them to share the savings. Risk is also shared for some provid-ers, primarily the integrated delivery systems that provide a broad range of services to a large number of enrollees.

The initiative has been a success, both from a finan-cial standpoint and from the perspective of integrating better care for the people served by Medical Assistance and Min-nesotaCare, Minnesota’s public health care programs. Pioneer-ing programs employ emerging professions like community paramedics to visit high-risk patients in their homes, and

work with patients to coordi-nate their care, preventing trips to the hospital. The goal of the IHP and similar value-based arrangements is to keep people as healthy as possible through improved access to preventive and coordinated care, rather than waiting until they need treatment for critical conditions in an emergency room.

In its first two years, the IHP saved more than $76 million, with most of the savings occur-ring during the second year. These savings arose from trans-forming health care delivery, including providing more direct preventive care, more coordi-nation, and fewer unnecessary hospitalizations and emergency

room visits. Providers and tax-payers received a share of the savings. The DHS is expected to announce the third year results by the middle of 2016.

Interest in the IHP initiative has been strong—after starting with six provider groups in 2013, it has grown every year. By the end of 2015, it reached

across Minnesota, with 16 provider groups covering about 225,000 people enrolled in public health care programs. The Minnesota DHS is working to expand the IHP initiative and comparable value-based reforms to about half of all public program enrollees—about 500,000 people—by the end of 2018.

How it all startedThe IHP’s roots go back to 2010, when state legislators autho-rized the DHS to test innovative health-care delivery systems, including ACOs. That led to the development of the IHP, orig-inally called the Health Care Delivery System (HCDS). The demonstration began in 2013 after the federal Centers for Medicare & Medicaid Services approved Minnesota’s new pay-ment model and congratulated Minnesota for being the first state to implement a plan in its Medicaid program that gave providers the incentive to work together to coordinate care.

Traditionally, providers have been paid for the volume of care provided, giving them the incentive to deliver more pro-cedures. In a major departure from this traditional model, the IHP’s new payment model gives providers a financial incentive to reduce the total cost of care, while maintaining or improving the quality of care for public program enrollees. Participat-ing providers are eligible to

share the savings starting in the first year. After the first year, some participants also share the risk if care costs more than the target. The model covers both managed care and fee-for-service care enrollees so pro-viders can focus on their whole population.

What IHP offersWith funding through a $45 million State Innovation Model (SIM) grant from the Center for Medicare & Medicaid Innova-tion, the IHP encompasses a range of providers, from large, integrated systems to regional providers, to specialty health providers delivering care for people with disabilities or com-plex medical conditions.

The IHP model gives each provider group the flexibility to design and develop their own approaches. Many participat-ing providers have taken steps such as providing more inten-sive primary care services and working with mental health care providers and community resources to better coordinate care. For instance, Mayo Clin-ic’s Employee and Community Health expanded locations, set more convenient hours, and encouraged patients to manage their chronic illnesses. Overall, efforts like these have result-ed in significant reductions in hospitalizations and emergency room visits, with risk-adjusted hospitalization rates down 14 percent and emergency room visits down 7 percent in 2014.

An emerging roleBefore joining the IHP in 2014, Hennepin County Medical Center (HCMC) was already a leader in developing the com-munity health worker role as an emerging profession in Minne-sota. HCMC started with four community health workers in 2010 and today has 24. Their goal is to help people and lower costs. They play an essential role in helping reduce health care disparities and increasing health equity.

Together, the members of HCMC’s community health worker team include people


Minnesota Medicaid ACO initiative from cover

The goal of the IHP … is to keep people as healthy as possible.

Your Link to Mental Health Resources


from multiple countries; the team can communicate with patients in four languages other than English. The team provides culturally specific and language-specific care coordi-nation, health education, and help navigating health care and community services. For example, a community health worker might help a patient navigate the health care system by helping them fill out the forms required to get them the

services they need, or by help-ing coordinate care for patients with chronic conditions by explaining transportation, ap-pointments, and prescriptions in a patient’s native language.

Aidoo-Abrahams approach-es her job with the empathy of someone who can relate to the people she serves because of firsthand experience. She faced the challenges of navigating Minnesota’s health care system after arriving here from Ghana more than a decade ago. Now she helps people stay on top of all the details and makes sure they follow-up for medical appointments, transportation, and medications. “It could be frightening and confusing, and it was not always easy,” she said, speaking of her own experience as a new immigrant seeking health care.

While working as a certified nursing assistant in nursing homes, Aidoo-Abrahams saw that people needed support navigating health care systems, particularly while managing chronic conditions. So she went back to school to earn a certif-icate to become a community health worker. “I empathize with new immigrants, with young mothers and children, with people who have chronic conditions who already have a

lot on their plate,” Aidoo-Abra-hams said. “They may forget to follow-up with appointments and take necessary medications that they need to be healthy.”

Aidoo-Abrahams said she sees her team’s role as “an essential part of the solution to closing gaps in preventive care related to income, ethnici-ty, race, culture, class, and geography, as well as increas-ing community capacity for better health.”

ConclusionBy creating incentives for providers to improve quality while reducing costs, and giving them the flexibility to develop their own approaches, the IHP initiative has put Minnesota at the forefront of innovation in state Medicaid programs. The goal of the IHP is to keep people as healthy as possible, and to treat them before they need expensive critical care in an emergency room or hospital. With providers continuing to join the IHP, it covers a growing share of the people served by Medical Assistance and MinnesotaCare, Minnesota’s public health care programs. The IHP’s flexibility has allowed providers to develop a range of strategies, including the use of community health workers to help patients navigate the health care system and reduce health care disparities.

Nathan Moracco has served as assistant commissioner for health care at the Minnesota Department of Human Services since December 2013. He previously served as director of the employee insurance division at Minnesota Management and Budget for more than a decade.

In its first two years, the IHP saved more than $76 million.

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ELECTRONIC HEALTH RECORDS


On Jan. 1, 2016, legisla-tion went into effect in the state of Minnesota

that will change the prescrip-tion prior authorization (PA) processing landscape. The legislation mandates that drug prior authorization requests must be accessible and submit-ted by health care providers, and accepted by group pur-chases electronically through secure electronic transmis-sions. The goal of the mandate is to unify stakeholders and the industry to promote the law and to reduce the costs and burdens associated with the drug PAs.

Existing prior authorization legislation

Currently, 24 states have laws pertaining to PA and seven have pending legislation; however, the Minnesota leg-islation is unique in its strict requirement for 100 percent electronic prior authorization (ePA) submissions. To date,

most states with PA legislation require the use of a universal form and promote electronic methods. While the use of a universal form is helpful in streamlining the abundance of paper forms required per drug and per plan, an electronic process creates greater efficien-cies for the prescriber, health plan, pharmacy, and patient. Recognizing this, California initially legislated a univer-sal paper form, and recently updated language to include

an electronic process follow-ing the National Council for Prescription Drug Programs (NCPDP). The NCPDP creates and promotes standards for the electronic exchange of health care information related to pharmacy solutions. Their solu-tions include real-time claim adjudication, eligibility and benefit verification, real-time ordering by the physician, and sharing of medication history.

The Minnesota ePA mandate

Minnesota is one of the first states to legislate 100 percent ePA requests and expressly exclude fax as an acceptable method of submission. It is also a bellwether state in that it has been on the cutting edge of electronic connectivity among stakeholders for almost 10 years. The latest mandate addressing the electronic pro-cessing of PA requests is one in a string of mandates surfacing from the Minnesota Omnibus Health and Human Services funding bill signed May 25, 2007, by former Gov. Tim Pawlenty. The bill provided funding for health information technology to improve patient safety, interconnect clini-cians and communities, and strengthen and improve public health in Minnesota. It also funded resources to support

administrative simplification and to establish and implement uniform electronic transaction standards for health plans and providers. The Minne-sota ePA mandate is the latest component of Minnesota’s overall effort to improve health care in the state through interconnectivity.

New requirements for physicians and their staff

While the Minnesota ePA legislation has the potential to positively impact the state’s entire health care industry, it most directly and immediately affects physicians and their staff. Prescribers and their staff must comply with this mandate by promptly adopting an ePA solution, and submit-ting all PA requests electroni-cally. Currently, some physician offices still use fax or phone to submit a PA request to the plan; however, this results in more

paperwork and waiting on hold, which ultimately delays treatment for the patient.

By submitting all PA re-quests electronically, prescrib-ers stand to gain back valuable time, save money, and elimi-nate frustration by skipping paper forms. In fact, based on survey data, physicians and their staff who use ePA solu-tions, including a Web portal, indicate that the process is three times faster than calling or faxing the plan. Ultimately, the main function of reducing hundreds of plan forms and PA requirements is to eliminate the possibility of patient aban-donment that can result from a lack of patient compliance.

Furthermore, adopting an electronic method allows the prescriber to capitalize on PA work already completed at

The Electronic Prior Authorization

MandateWhat physicians need to know

By Perry Lewis

At least 71 percent of PA requests are initiated at the pharmacy.


the pharmacy. Data from the Electronic Prior Authorization National Adoption Scorecard published by CoverMyMeds indicates that at least 71 per-cent of PA requests are initi-ated at the pharmacy. During this process, pharmacy staff completes a portion of the necessary patient, medication, and health plan information, limiting additional work required from the prescriber. The majority of pharmacies begin PA requests electroni-cally and make them available to prescribers online. Pre-scribers simply need to access the request through an online Web portal or their electronic health record (EHR) system to electronically submit it to the health plan.

How prescribers can comply

Complying with the Minnesota ePA legislation is fairly simple for prescribers and costs noth-ing. Prescribers have several options discussed here.

Electronic Health Record (EHR) System: Some prescrib-ers already have access to an EHR system with integrated ePA capabilities. In this case, the prescriber can initiate or complete a PA request directly within their EHR workflow. In most systems the prescriber will be prompted to complete a PA during the e-prescribing process when patient data re-quires it, or after a PA request is started by the pharmacy on their dashboard or in-basket.

The benefit of using an EHR system for PA requests allows the prescriber to work in one system for their patients’ pre-scription needs. Additionally, it creates the ability to prospective-ly (at the point of prescribing) initiate a PA request and avoid a delay in patient treatment. Today, nearly half of the leading EHR systems have integrated ePA capabilities, including Epic, DrFirst, NewCrop, and Practice Fusion. Several of the largest systems are working toward providing ePA capabilities. Infor-mation on the availability of ePA in EHR systems can be found in

the Electronic Prior Authoriza-tion National Adoption Score-card available at epascorecard.covermymeds.com.

In order to fully realize the benefit of this legislation, more prescribers need access to ePA functionality in their EHR. This allows prescribers to ac-cess one system to manage all prescriptions and PA require-ments for their patients.

Web Portal: If a physician does not have access to an EHR with ePA capabilities, they can use a Web portal to create PA requests and com-plete requests started by the pharmacy. Web portals for ePA are typically free for prescrib-ers and offer a quick, easy way to begin PA requests in a matter of minutes by simply creating an account. Any staff member responsible for PA requests can create an account. Because many physicians still do not have access to ePA in their EHR, an online portal for PA is a great and immediate solution that will allow them to comply with the Minnesota ePA mandate.

Payers and prescribers working together

By implementing an ePA solution, health plans have the option to provide prescribers with plan-specific criteria tailored to each patient and their diagnosis. The prescriber will fill out the required fields provided by the payer, which eliminates the plans’ need for more information. This will help expedite the process, limit the painful back and forth between payer and prescriber, and often lead to real-time determinations. By integrating with an ePA online portal, pay-ers can help make the process

easier for physicians to remain compliant with the new legisla-tion, ultimately assisting them in getting the patient their medication as fast as possible.

A brighter future

The Minnesota Department of Health is aware that not all participants in the system will be live with an electronic solution and have provided for those exceptions to apply and obtain waivers for the time being. The law states that all stakeholders should be work-ing toward compliance to reduce the burdens and costs associated with processing PA requests through other methodologies. So in terms of

implementing a solution: the faster, the better.

The ultimate goal of this legislation is to align health plans and prescribers, touching on all areas that are adversely affected by PA. The Minnesota Legislature will accomplish that goal if prescribers take the necessary steps to use an ePA solution, payers unanimously adopt ePA, and EHR systems continue to integrate ePA capa-bilities into their workflow.

Perry Lewis is vice president of industry relations at CoverMyMeds, with a focus on pharmacy associa-tion engagement and leading ad-vocacy efforts in both the state and federal arena pertaining to electronic prior authorization (ePA). In 2016, Lewis will be appointed to the board of the National Council for Prescrip-tion Drug Programs (NCPDP).

Minnesota ePA legislation is fairly simple for prescribers and costs nothing.

Your Link to Mental Health Resources

CARDIOLOGY


Technological advances have made the transra-dial artery method safe

and effective for interventional cardiologists willing to jump back on the learning curve. At HealthEast, all intervention-alists regularly use the radial artery as an access point for coronary angiography and oth-er interventions. The technique involves inserting a tube with a one-way stopcock, referred to as a sheath, into the radial artery at the wrist, then using fluoros-copy to guide it up the arm and to the heart.

While standard in much of Europe, the wrist-based tech-nique using the radial artery is just starting to hit its stride in the United States. The femo-ral artery approach has been the mainstay in the United States, overtaking the brachi-al approach in the late 1970s and early 1980s. The radial approach for coronary angiog-raphy advanced in the late 1990s as an alternative to accessing

the femoral artery through the groin, but, due to challenges with sheath design, usage waned until improvements were intro-duced eight to nine years ago.

Previous sheaths could stick to vessel walls and case reports noted tearing of the radial artery intima during sheath re-moval. With more cardiologists and radiologists using the radi-al approach, a new generation of sheaths and catheter shapes has recently been developed, producing desirable outcomes and greatly improving the patient experience. The key advancement is a hydrophilic coating that prevents the sheath from sticking.

Vasodilator delivery also has eased the navigation of sheaths through the radial artery. Administering medication such as nitroglycerin and calcium channel blockers to dilate the vessel has dramatically re-duced the incidence of artery spasm, a painful and sudden constriction.

A learning curve

The transradial method pres-ents several challenges for interventionalists, but none that cannot be overcome with experience. It may take 50 to 100 procedures to achieve proficiency. In general, opera-tors will learn how to respond to four operational hurdles: 1) inserting the tube, 2) navigating loops and bends in the artery, 3) navigating the aortic arch by the chest, and 4) cannulating the right and left subclavian arteries. In time, responses become routine and a sense is developed for when it is safe to continue and when it is prudent to change to using the femoral artery for access.

Transradial access involves a small artery and a small nee-dle, and the use of ultrasound for assistance during catheter insertion helps prevent vessel damage. While this presents another technique to learn, it takes only five or 10 cases to become comfortable. Besides allowing the interventionalist to visually guide the tube into the artery, the use of ultrasound

quickens procedures, and it can be used as a preoperative screening tool for vessels that are too small or calcified.

The operator must pay par-ticular attention to anticoagula-tion medicine and dosing. Care must be exercised when apply-ing a band over the radial ac-cess site during sheath removal, as proper technique lowers the risk for bleeding and clotting of the radial artery.

The benefits

The transradial and transfem-oral methods share several complications: bleeding, stroke, nerve damage, and surgery to repair the artery. The trans-radial method stands out by offering a significant reduction in time to ambulation. While patients undergoing catheter-ization through the femoral artery must remain prone for several hours, the mobility of those recovering after radial artery access is limited only by sedation. Thus, the method holds added appeal for patients with back problems or who are morbidly obese.

The wrist should be mon-itored for bleeding for two to four hours, while leg bleeding or ischemia requires three to 10 hours of monitoring. The convenience of rapid mobility through the transradial ap-proach can be significant, as quicker discharge can prevent

overnight stays and lower costs. Combined, these factors put patients of the transradial method at ease because they make the procedure feel less invasive.

Radial artery access boasts outcome-related advantages, as well. Bleed-

ing is easier to identify and control from the wrist than the groin, so the common compli-cation of access-site bleeding is limited. This is particularly noteworthy for patients on anticoagulation medication such as warfarin. Radial access also removes the risk that transfemoral access carries for catheter-related deep vein thrombosis.

Radial accessNo longer radical

By Carmelo J. Panetta, MD

It may take 50 to 100 procedures to achieve

proficiency.


Due to a secondary blood supply from the ulnar artery, the transradial technique car-ries less risk for limb damage than the brachial or femoral arteries. A criticism of the transradial method is that cath-eterization can lead to radial artery occlusion (RAO), but ultrasonography analysis and publication in abstract form of about 1,200 cases at HealthEast showed occlusion rates of only 1 percent. One complication of radial artery access, com-partment syndrome, requires special surgery, but this com-plication is extremely rare. For those who become proficient in radial access, several stud-ies have shown a reduction in death with radial approach for those with acute heart attacks.

Generally, the vast majority of patients can be considered candidates for the transradial method. With that said, certain cases certainly warrant the use of transfemoral access. While the most common catheter size

for angiography, 4 French (1.3 mm), fits in the radial artery, the femoral artery is a better choice when an 8 French (2.6 mm) catheter is needed.

Transradial access is dis-couraged for patients on or near dialysis, as the radial artery is used for grafts and fistula. Walker-dependent patients are not ideal candidates, as unnec-essary pressure applied to the

wrist is not advisable following the procedure. Candidates for radial artery access should have their blood pressure screened and undergo a Barbeau test (similar to the Allen’s test) to document dual circulation to the hand using pulse oxymetry.

A safe environment

While the transradial approach is technically challenging, its advantages become inherent as a cardiac program increases its use and the operators gain experience with it. The meth-od’s benefits in the heart attack setting, for example, would not be within reach until an inter-ventionalist is sufficiently com-fortable with the technique.

As HealthEast’s program is unique in Minnesota in that every interventionalist uses the method—and is one of the largest in the state in sheer numbers of radial artery access procedures—a system is in place beyond the cardiologists. Nurses and X-ray technicians

in the cardiac catheterization laboratory and those handling recovery on the hospital floor have completed extensive training with the rare compli-cations and are adept at quickly responding, creating a safe environment across the board for the approach.

With the radial artery prov-ing to be a reliable access site, the advantages of transradial access related to patient out-comes and convenience should make it not merely a useful alternative for certain patient populations but the standard method for coronary angiogra-phy and interventions.

Carmelo J. Panetta, MD, of HealthEast Heart Care, is board-certified in cardiovascular medicine and interventional cardiology and practices at HealthEast St. Joseph’s Hospital in St. Paul. His interests include angiography, interventions via the radial artery, and closure of atrial septal defects of the heart.

Bleeding is easier to identify and control from the wrist than the groin.



Maximizing Medicare fee-for-service (FFS) revenue has become

more challenging than ever. At times Medicare reimbursement seems to scarcely cover clinic costs, and now all physicians need to be concerned about having money taken away. Be-ginning in 2015, the Centers for Medicare & Medicaid Services (CMS) has three quality incen-tive programs—Medicare Elec-tronic Health Record (EHR) Incentive Program, Physician Quality Reporting System (PQRS), and the Value-Based Modifier (VBM) Program—concurrently impacting all physician offices. The programs will help move the health care industry from paying for ser-vices, to paying for value and quality. Incentive programs that previously only applied to large practice groups, now apply to smaller group practices and solo practitioners as well. Not meeting the requirements of the three programs can result in CMS withholding up

to 9 percent of your Medicare Part B FFS revenue in 2017.

To avoid negative payment adjustments or achieve bonuses, eligible professionals (defined as physicians, physician as-sistants, nurse practitioners, clinical nurse specialists, nurse anesthetists, and others de-pending on the program and the year) need to:

• Attest to meaningful use through the Medicare EHR Incentive Program

• Report quality data through PQRS

• Provide care that is equal to or better than the mean

national quality-cost com-posite score to the Medicare beneficiaries attributed to them for the Value-Based Modifier Program

Slightly different rules for these programs apply to eligible professionals whose organiza-tions are part of a Medicare payment reform program, such as a Pioneer ACO. For the Value-Based Modifier Program, which applied to only 100+ eligible professionals in its first year, CMS projects negative payment adjustments of over $11 million based on their per-formance on quality and cost measures in calendar 2013.

Do PQRS measures apply to me?

One Minnesota specialty clinic estimates that in 2016 they will lose Medicare payments equivalent to its office man-ager’s annual salary. Like this clinic, many others will lose out for several reasons. Smaller clinics, especially specialty clinics, didn’t believe that PQRS measures would apply to their practices. Not only were they surprised when they learned from CMS that they did, espe-cially with the introduction of cross-cutting measures, they also discovered reporting is complex. To make matters worse, many EHRs are unable to support reporting although it’s required for PQRS. Because the performance period for

reporting is based on data two years prior (i.e., payment adjustments for 2016 are based on calendar year 2014), pro-viders who are just beginning to fully understand reporting requirements are at risk for negative payment adjustments in 2016 and after.

These programs are part of the plan to achieve the U.S. Department of Health and Human Services’ goal of tying 85 percent of all FFS Medicare payments to quality or value by 2016 and 90 percent by 2018. Physicians need to understand the evolving quality incentive programs to maximize their Medicare payments.

The three current quality incentive programs (see Table 1) will run through Dec. 31, 2018. On Jan. 1, 2019, they will sunset and morph into the Merit-Based Incentive Payment System (MIPS) for data collected in 2017. Being engaged and partic-ipating fully in these programs now is one of the most important

steps physicians, other eligible professionals, and their organi-zations can do to avoid penalties and receive positive payment adjustments in the future.

Quality and value

VBM and MIPS move from paying for reporting, to paying for quality and value. These programs provide an opportu-nity to earn bonus payments for having better than average com-posite scores for quality and cost. Scoring is done through a multi-step methodology based on ambulatory care sensitive conditions, as well as other factors such as per capita costs for all attributed beneficiaries. Each fall CMS releases updated scoring information through

Maximizing Medicare payments

A look at incentive programs

By Candy Hanson, BSN, PHN

Table 1. Timeline for evolving CMS quality incentive programs

Time-frame

Medicare Quality Incentive Programs Data CollectionPeriod

Ending Dec. 31, 2018

Electronic Health Record (EHR) IncentivePhysician Quality Reporting System (PQRS)Value-Based Modifier (VBM)

Through 2016

Starting Jan. 1, 2019

Merit-Based Incentive Payment System (MIPS)

Starting 2017

Source: Stratis Health

Maximizing Medicare payments to page 36

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My son, Siah, broke his finger playing foot-ball his senior year in

high school. I took him to the doctor, where he was urged to get an X-ray. The doctor told him that he would need a cast, and that we should visit an orthopedic surgeon. He put a splint on Siah’s finger and sent us on our way.

The next day at the ortho-pedic surgeon’s office, the nurse informed us that they needed to take another X-ray. Even though Siah’s finger had been X-rayed the day before, the nurse insisted that medical protocol required an additional image before they could move forward. I persisted in ques-tioning the need for another X-ray and after consulting with the doctor, he decided that a cast was not needed nor was another X-ray. The doctor sim-ply readjusted the splint, and said that unless Siah experi-enced more pain or problems, he didn’t have to come back. My wife and I estimated that we

saved $2,000 because we didn’t have to take off additional time from work or pay for extra X-rays and office visits. We also saved money because Siah didn’t need pain medication.

This experience taught us some important lessons. Not only about the importance of health care literacy, but also what an active role we need to take in our health care, as well as how important it is to partner with our health care providers.

In today’s health care en-vironment, quality and out-comes are more crucial than ever for reimbursement and patient satisfaction. One way to ensure that outcomes are the

best they can be is to focus on health literacy. When everyone from patients to staff are better informed about how the health care system works, we all ben-efit, from increased efficiency to improved patient/provider interactions. Ultimately, this positively impacts all involved, from families like mine to doc-tors and clinic staff.

What is health literacy?

According to the National Center for Education Statistics, health literacy can be defined as, “the degree to which indi-viduals have the capacity to obtain, process, and under-stand basic health information and services needed to make appropriate health decisions.” The National Assessment of Adult Literacy gives a broader perspective that defines health literacy as “the ability to use printed and written informa-tion associated with a broad range of health-related tasks to accomplish one’s goals at home, in the workplace, and in the community (including health care settings).”

Health literacy involves getting to know how the health care system works as a whole. For example, a patient needs to understand the difference between the types of organiza-tions they can go to for care. They could go to online clin-ics, walk-in clinics at popular

retailers, primary care clinics, urgent care facilities, or emer-gency rooms. And once patients get to the right place, there is much more beyond that to understand, from how their in-surance benefits work to how to make sure they have the correct diagnosis and treatment plan. They also must know how to get the right price for their treat-ment to ensure that they don’t pay more than what’s necessary.

The importance of health literacy

Many patients, like my son, have learned that to avoid unnecessary physical, emo-tional, and financial costs they must be health literate. This means that patients should be able to understand and evaluate basic health information and feel comfortable enough to ask questions. By being health lit-erate, they can make sure that they’re getting exactly the kind of care they need at the best price possible. It also means that as people continue to gain this knowledge, the relationship between the patient and the provider will need to continue to transform from transac-tional to collaborative.

Health literacy is also important to doctors because educated patients are healthi-er. These patients tend to have better health outcomes and save more money, which in turn creates a better doctor/patient and clinic/patient partnership.

Companies such as Trig, the company I work for, are help-ing patients understand how to interact with the health care system so they can improve out-comes. But patient education doesn’t have to start or stop there. Doctors and clinics can encourage patients to become active participants in their care by being educated, informed consumers who understand how the health care system actually works.

What physicians and clinics can do

When it comes to helping the consumer become health

Health literacyCreating a better-informed patient

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literate, there are some key ways that physicians and clinics can help.

Determining how health literate a patient is

From a statistical stand-point this is not too difficult, as the studies conducted by the organizations mentioned earlier in this article show that only 12 percent of peo-ple are health literate. So it would be safe to say that nearly 90 percent of your patients are not. But just in case, there are a couple of key components to assessing a patient’s ability to take in health literacy infor-mation. At the end of the day, whether a patient adheres to a treatment plan is going to affect outcomes for all involved. The following components of health literacy are key because they allow someone to quickly assess how well a patient is going to be able to navigate the health care system and follow their treat-ment plan.

The first is how many ques-tions the patient asks during an appointment. If they’re not interactive, they’re likely not at a high level of health literacy. The second is whether they can restate what they’ve been asked to do. If they can’t, then they don’t understand their treatment plan, and their level of health literacy is likely low. When patients aren’t at a high level of health literacy, then out-comes will likely be negatively impacted.

If a patient is health literate, they will likely already know how to ask the right questions, look for information, and fol-low treatment plans. For those who are not health literate, however, they need to be en-couraged to play a more active role in their care.

Improving patients’ health literacy levels

There are several ways that physicians and staff can improve patients’ health literacy levels:

• Place a strong emphasis on treatment efforts. Many times, a patient may be

given a sheet of paper that explains a treatment plan. But a piece of paper does not guarantee a high level of adherence to the plan.

More often than not, unless more attention is given to this plan it will be the same as speaking Greek to the pa-tient. Walking them through the details of their treat-ment, such as medications or therapies, will help them become more educated and more engaged in their care.

• Make sure the patient is part of the care process as much as possible. When entering information into a patient’s health record, for example, make sure they see what is going into the record and that they understand the in-formation. Or check in with the patient about their needs and expectations during their care. For example, ask someone about their budget and what their health goals are. The more that patients are a part of the process, the more knowledgeable they will be and the better outcomes will be as well.

• Ensure that front desk staff have a good grasp of common health benefit terminology. For example, not everyone knows what a co-pay is. When staff know common terminology, they can better serve and educate patients.

• Maximize the potential of electronic health records. This can be a challenge not just for EHRs but any software. It is important to make sure both staff and pa-tients are making the most of this tool. Proper docu-mentation will help everyone keep track of what has been learned so far in a patient’s health care journey. Be sure that people understand how

a tethered personal health record can improve their care by making sure you have the most current infor-mation available.

Conclusion

In today’s health care environ-ment, for both patients and

caregivers, outcomes are more important than ever. Improv-ing patients’ health literacy levels can go a long way toward improving outcomes. When

patients are engaged in their care and actively work toward their treatment goals, this can make a huge differ-ence for everyone involved.

Mick Hawton is vice president of Strategy and Product Development at Trig, a health care training company.

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PROFESSIONAL UPDATE: MEDICAL ETHICS


In the movies and on televi-sion, dramatic music or the sight of a police officer at

the door signals impending bad news. In reality, breaking bad news is rarely straightforward: not only must information be provided, but comprehension of that information must also be assessed before proceed-ing with additional planning for care. Physicians delivering bad news face the challenge of providing negative information to patients and/or families in less-than-optimal settings, with less time and space than is ideal. It is perhaps not surprising then, that many physicians avoid or cut short these difficult conver-sations. I will discuss breaking bad news to patients and fami-lies, with an emphasis on social and ethical considerations.

Discussing bad newsThe concept of patients being made aware of bad news is, somewhat surprisingly, a rela-tively novel concept. Just a few decades ago, medical profes-sionals willingly and knowingly

withheld unfavorable infor-mation from patients. In 1961, Oken published a classic study in JAMA investigating whether physicians counseled patients about cancer diagnoses: 90 percent of physicians preferred not to tell patients about their diagnoses, citing “experience” (in quotes because this was cited similarly by new physi-cians and those who had been in practice for long periods) as well as an inability to treat the diagnosis. By 1977, Novack et al. found that 97 percent of physicians favored informing patients of a cancer diagnosis, a shift likely brought about by changes in medical edu-cation and increasing respect for patient autonomy (e.g., the 1973 Patient Care Bill of Rights passed by the American

Hospital Association, now called the Patient Care Partner-ship). Although the proportion of physicians informing patients of an undesirable diagnosis has increased, the scope of infor-mation provided to patients is widely variable and may not always be complete. In 2001, a study (Lamont and Christakis) of hospice-based physicians reported that only about a third would provide comprehensive prognostic information to ter-minally ill patients.

Contemporary literature on this topic reflects near-uni-versal agreement that patients should be made aware of their diagnoses and health status unless there is a compelling reason not to do so, and empha-sizes optimizing the delivery of this information in a personally

sensitive and culturally compe-tent manner (Surbone, Lancet Oncology, 2006). It’s important to note that this may not actu-ally be the case in practice. In order to bridge the gap between desired and actual outcomes, clinicians must be aware of the challenges inherent in diffi-cult conversations, and must be alert for patient, clinician, and external factors that may impact this interaction.

Potential barriers to breaking bad newsBoth patients and clinicians may create an environment where breaking bad news is avoided. Many clinicians cite fear of the patient’s reaction (from crying to depression to suicidality) as a reason to dislike or avoid giving bad news. Over 40 years ago, Tesser and Conlee identified “patient emotionality” as a key factor in delivering bad news. They found that study participants were less likely to want to break bad news to a recipient who was perceived as emotional than

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to those described as calm or about whom the news bearer had no information. Rosen and Tesser coined this preference to deliver positive messages the “MUM effect,” postulating that this reflected a dislike of giving bad news and/or an enthusiasm to give good news.

While some clinicians may find it reassuring that their hesitance to deliver bad news is scientifically validated, it must be pointed out that Tesser and Conlee’s study was based on third-party, word-of-mouth assessments regarding the emo-tional state of the recipient. In other words, patients’ emotional states were determined by the assessment of others, rather than by asking the patients. This reality has significant implications for the physician/patient relationship: the (some-times erroneous) assumption that particular behaviors or expressions portend specific emotions may lead clinicians to (sometimes erroneously) predict a given patient’s response to bad news. Phrased this way, it

is easy to see how an apparent desire to protect the patient actually reflects an underlying respect for patient individuality and autonomy. Equally import-ant in the physician/patient interaction are the concepts of transference and countertrans-ference, where one party takes on the emotions that he or she perceives are being expressed by the other party. In many cas-es, physicians may also be able to identify their own emotions or behaviors that affect their ability to give bad news (e.g., a

patient reminding a physician of his or her grandmother).

Achieving and maintaining awareness of one’s own emo-tions, and checking in with the patient about his or her emo-tional status prior to delving into a discussion of bad news, is crucial groundwork needed

to set the stage for a meaning-ful discussion. While personal awareness training can help physicians to become more aware of their own emotions and behavior (Smith, Dwame-na, & Fortin, 2005), such train-ing is not yet universal in medi-cal school and graduate medi-cal education, despite published data suggesting that learners would benefit from emotional support from peers as well as repeated skills practice (Dosan-jh, Barnes, & Bhandari, 2001).

How to break bad newsThere is no simple “recipe” for breaking bad news. Ideally, bad news should be delivered in a “safe” physical and emotional environment for the patient; that is, a respectful space free of distractions. Many physicians find that time constraints and

the limitations of physical space can create discomfort for one participant in the conversation or the other. The physician should ensure the patient’s physical comfort by finding a private, quiet area without environmental distractions (e.g. bright sun shining in the window or nearby construction) and ideally with comfortable seating for everyone attending (Baile, Buckman, & Lenzi, 2000). If the discussion of bad news is not an urgent one, some physicians may choose to pro-vide limited information to the patient and ask the patient to return in several hours or days (and often to bring a compan-ion) to continue the discussion when physical and emotional conditions are more favorable.

Although setting an agenda is useful in many patient/physi-cian interactions, it is especially important when breaking bad news. Allowing enough time for the anticipated conversation, and informing patients of the time constraints, may avoid the

Neither physicians nor patients enjoy a discussion about bad news.

Breaking bad news to page 38

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HEALTH DISPARITIES


East African culture has its own way of conceptu-alizing, expressing, and

treating mental illness. African concepts are rooted in religions that came to Africa centuries ago from both Europe and the Mid-dle East and from the African indigenous traditions that were practiced long before outside influences. Even though both Christianity and Islam discour-aged indigenous cultural prac-tices, many communities figured out ways to incorporate them.

Somali perceptions of mental illness

Somalis express mental ill-nesses in several ways. Murug implies everyday sadness, stress, or depression and is associated with the migration process, financial stressors, experience in exile, and loss of family lives and property during the Somali civil war. Symptoms include flashbacks, headaches, loss of interest, loss of appetite, poor sleep, crying easily, and lack of social activity.

Waali translates as “crazy” or “mad.” Symptoms of waali include violent behavior, tak-ing off clothes in public, and talking nonsense or talking to oneself. Members of the family and the community usually help the person seek treatment of waali. Jinn is a “stigmatizing form of mental illness” caused by a powerful being who is ca-pable of exerting influence over human action and behavior (Carroll, 2004). The symptoms include appearing “uncon-scious,” spirit possession (disas-sociation), being mentally unfit, being afraid, and going mad.

Other common beliefs in-clude zar, the dominance of the

evil spirit over a person in order to cause harm. Zar is based on the idea that the evil soul makes certain demands that must be fulfilled by a person or his rel-atives; otherwise, the evil spirit will cause trouble for that per-son. Other disorders are caused by sihir, a fetish or charm devised by one person to inten-tionally cause harm to another or by the evil eye, brought on unintentionally. For example, excessive praise or attention can attract evil spirits to an infant or child, which account for the custom of shielding newborns from outsiders for the first four months of life. Both sihir and jinn come from Islam, but evil eye and zar originate in African traditional practices that pre-date Islam and Christianity.

Common to all these beliefs is the idea that the disorder is caused by some external force that may inhabit the self but is not organic or inherent to the self. Mental illness is rooted in the world of spirits rather than the brain and emotions. The flaw is not in the person but in the external force that occupies the person, and that force needs to be cast out.

Somali perceptions of treatment

In East Africa, mental illnesses are usually treated by both traditional African healers and religious healers. Colonial pow-ers introduced Western medi-cine, which now coexists with traditional practices. However, it is neither as accessible there as here nor practiced the same way. For example, Western-style doctors in Africa do not educate patients or offer them support systems like nutritionists, nurses, mental health practi-tioners, and such.

Traditional African heal-ers consist of herbalists,

bonesetters, and traditional spiritual leaders. Religious healers can be divided into two types: Koranic healers, who recite Koranic verses to the person, and Sufi healers, who, in addition to reciting the Koran, use spiritual transcen-dence mindfulness practices. Both traditional and religious healings mostly focus on driving spirits away from the person or undoing the harm through ritual practices and giving the person special care. In the case of zar, ritualized dancing is used to drive away the spirits, while in jinn and other religious-based ailments, Koranic readings are standard treatment.

Healing is viewed as a strug-gle between an external healer (traditional or religious healers) and a bad agent (zar, jinn, sihir, waali, and so on). Treatment is viewed as a rescue from the bad agents causing harm. In Africa, treatment by external healers galvanizes the family and com-munity who participate in the healing rituals. If the patient cannot be rid of the condition and develops a long-term im-pairment, the family is expected to counterbalance the ill effects by caring for the person.

Cultural considerations when treating the Somali population

Pre-immigration stressorsDuring the Somali civil

war, citizens lived in a fight-or-flight mode. Often Somali men experienced torture, and Somali women experienced both torture and rape intended to terrorize them into submis-sion. Many surviving Soma-lis, both adults and children, witnessed the murder or torture of family members and friends. As a result, many suffer from traumatic memories, flashback, depression, and anxiety.

Effects of life in the refugee campsMany Westerners misunder-

stand life in a refugee camp. In the camps, most of the refugees are in survival mode. There is a constant threat of sexual violence and attacks from rival clans within the camp and hos-tile local populations outside.

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In addition to the traumatic ex-periences are deprivations such as poor housing and shortage of water and food. Lack of em-ployment in the camps causes refugees to develop a sense of loss, low self-esteem, and help-lessness. Refugees who settle in camps in other countries are not allowed to leave the camp to seek employment or education or to participate in any activ-ities that require legal docu-ments. Refugees are expected to stay in the camps until their country becomes peaceful or they are allowed to emigrate. By 2003, the average wait at Daadab, the largest camp in Kenya, was 17 years (The New York Times, 2011). Some of the most common mental illnesses of the refugees are depression, bipolar disorder, PTSD, schizophrenia, disassoci-ation, and anxiety disorders.

Resettlement in Western communities

Once refugees emigrate to a third destination such as the

U.S., they face stressors such as acculturation, poverty, lack of employment, and language barriers. Many Somalis strug-gle with the disintegration of their traditional social networks after losing family members and friends during the civil war, in the refugee camps, or in the resettlement process. The devastation resulting from the loss of social support they been accustomed to throughout gen-erations cannot be overstated.

Barriers to seeking helpA number of common issues

arise when Western mental health providers seek to treat East African immigrants.

1. The Somali view of mental illnesses is very different from the views of Western

health care providers. The belief that mental illness is caused by supernatural and spiritual possessions is as real to African refugees as empirical evidence and sci-entific process are to West-ern society.

2. There is a widespread fear of being detained and hospi-talized if one is diagnosed with mental illness. This fear comes from Somalis’ experience of “Westernized”

treatment in Africa, where hospitalized patients are sometimes chained and drugged with no hope of recovery. There is a misun-derstanding among Somalis about psychotropic medica-tion, since some of them are familiar with antipsychotic

medication and its side effects. They assume that every medication has similar side effects.

3. Somalis may sometimes feel that their disorder is not severe enough to warrant treatment. Having survived horrific situations in the war and the camps, the discom-fort of anxiety and depres-sion seem relatively manage-able. There is a mismatch between Somali and West-ern ideas about what defines mental illness and what is considered severe. The range of “normal” behavior in Afri-ca is wider than in the West. Milder forms of mental illness that would be treated by professionals in the West are accepted in Africa and addressed within the family.

4. The Western approach is to help individuals learn strat-egies for healing themselves, but Somalis view a more passive role for themselves,

Mental illness is rooted in the world of spirits rather than the brain and emotions.

East African culture and mental health to page 40

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MEDICINE AND THE LAW


Intellectual property in medicine

A guide to an effective patent strategy

By Sean Solberg, JD

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.

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Physicians are well-positioned to generate new inventions and

thereby improve the treatment of their patients. As a result, physicians have historically been some of the best and most active inventors in the United States. One of the keys to commercial success for any inventor is a sound intellectual property (IP) strategy.

Initial considerations for your patent strategySo, you are a physician and you have an idea. What do you do next? The following are the key steps and considerations for developing a strategy to protect your technology.

Disclosing your ideaConfidentiality is key. Don’t

tell anyone about your idea because disclosure can create significant problems. If you were to disclose your inven-tion to a third party without a confidentiality agreement in place, you would technically have one year in which to file a

patent application in the U.S. In contrast, any such disclosure precludes you from pursuing patent protection in most other countries. Plus, disclosure to a third party creates the obvious risk of that party copying your invention and pursuing develop-ment. What constitutes disclo-sure? Don’t take any chances—do not disclose your invention to anyone without first consult-ing a patent attorney.

There are situations, such as talking to a potential business partner, in which it may be nec-essary to disclose your inven-tion to a third party before you file your patent application. If you haven’t filed your patent ap-plication and you must disclose

the invention, an appropriate confidentiality agreement drawn up by your patent attor-ney can preserve your rights to pursue a patent application.

Regardless, the best ap-proach is to file your patent application before you disclose your invention, which elimi-nates the risk of public disclo-sure. In fact, the recommended strategy is to use confidentiality agreements for any disclosures even after you file your patent application. Your invention is still a trade secret after fil-ing and until the application publishes. A confidentiality agreement at this point can also protect against public disclo-sure of any additional inven-tions or improvements you may have developed since you filed the application.

Hiring an attorneyIt is important to find a good

patent attorney. Developing an effective patent strategy is complex and not for the inex-perienced. It is critical to have an expert involved early in the invention process. Hiring an attorney who has expertise in your technology and experience with physician-inventors is a plus. Most important, find a patent attorney with whom you have a great connection and relationship, because trust and communication are as critical as expertise.

Who owns your invention?As to the question of own-

ership, the answer depends entirely on whether you are an employee or independent con-tractor based on your contract with your hospital or medical clinic. Many physicians are con-tractors and own any inventions they create. Of course, owner-ship depends on the specific language in the contract. If you are a contractor and your contract does not include an

obligation to assign your inven-tion rights to the hospital or clinic where you work, then you likely own your own IP rights free and clear, and can pursue patent protection. On the other hand, if you’re an employee, it is possible that your employment contract requires you to assign all of your intellectual prop-erty rights to your employer. Regardless, the key is to have your patent attorney examine your contract to determine your rights and obligations.

Prior artBefore you go any further,

you also need to consider whether your invention is ac-tually patentable. Your patent attorney can perform a pat-entability search prior to filing your application. The attor-ney—or a third party search firm hired by the attorney—will search specific databases for any publications, patents, or published patent applications describing prior inventions (re-ferred to as “prior art”) similar to yours. The attorney will then analyze those search results to determine whether your inven-tion is novel and non-obvious in view of the prior art. If those results are positive, then you can file your patent application. Prior art search results also help your patent attorney (and you) to describe your invention to distinguish it from that prior art, thereby strengthening your application and chances for receiving a patent.

On the other hand, there are some reasons not to conduct a patentability analysis at this early stage. An inventor should understand that there is no obligation on the part of the patent applicant to do any kind of search for prior art. There is an obligation to disclose to the U.S. Patent and Trademark Office (the “Patent Office”) any prior art of which the applicant is aware. While a patentability search and analysis is a good idea when money is not an issue, you can file the patent application without first paying for a patentability analysis if your budget is limited. Alterna-tively, you can get a sense of the prior art in your area of tech-nology by doing a very rough


A patent does not protect against potential infringement.

prior art search yourself on the Patent Office website—the database can be found at http://patft.uspto.gov/.

Freedom to commercialize your technologyNow that you have a better understanding of patent strate-gies, it’s time to consider com-mercialization. Many inventors think that patent strategy is focused solely on filing a patent application. Nothing could be further from the truth. If commercialization is the goal, a patent alone is not enough.

Before you can develop, market, and commercialize your technology, you also need to consider whether you have “free-dom to operate.” In other words, you need to determine whether you are free to commercialize your technology or whether that commercialization might infringe another party’s patent.

The fact that a patent does not protect against potential infringement of others’ pat-ents can seem counterintuitive to first-time inventors. This confusion originates from a fundamental misunderstand-ing about what rights a patent conveys to a patentee and—just as important—what it doesn’t convey. While a patent gives the patentee the right to exclude others from making, using, or selling the invention as defined by the claims, it does not give the patentee any affirmative right to commercialize that technology. Your patent is not a free pass to develop, market, or sell your invention.

In addition to pursuing patent protection, you also need to work with your attorney to determine whether you have the freedom to commercialize your technology. Typically, this process involves a search for relevant third party patents and some analysis of those patents by your attorney.

Tailoring your patent strategyYou may be wondering why we haven’t talked about the actual patent application process. That’s because it is critical to have your overall patent strat-egy in place even before you file

your first patent application, and that strategy must fit with your business plans. You want to be sure that your patent filing strategy matches your commercialization strategy and vice versa. Much also depends on your end goal for your inven-tion. Your specific approach to IP protection will be influenced by whether you’re going to start a company, license your invention, or simply sell your IP rights outright to a third party.

Funding concernsRegardless of your specific

strategy, you will need funding to get things off the ground. Will you fund the venture your-self, or target investors, such as private angel investors or an angel fund? If personal funds are not an option, then you will need to reach out to investors. Any chance of success with in-vestors depends on an IP strat-egy that is tailored to address the concerns of those investors. Plus, communicating with investors leads to a situation in which you need to protect against any risks of disclosure. This situation is further com-plicated by the fact that some investors refuse to sign confi-dentiality agreements because it presents too great a risk for them. Keeping the end goal in mind will help you prepare for these types of contingencies.

Starting a companyIf your goal is to start a

company, your strategy may be to focus on keeping costs down while pursuing a slower-paced patent strategy. For example, it may make sense under this strategy to initially file a provi-sional patent application here in the United States. A provisional application is a low-cost mecha-nism for getting an effective fil-ing date for your patent applica-tion that has a non-extendable 12-month pendency period and fewer requirements than a standard non-provisional patent

application. The provisional application delays the filing of a non-provisional application by a year, thereby deferring some costs and the patent process while giving you the additional time to develop your technol-ogy, raise money, etc., prior to filing the more expensive non-provisional application (and any foreign applications).

In addition to lower upfront costs and more time to devel-op your technology, another

advantage of the provisional application route is the speed of filing. If you are pushing to raise money while trying to keep costs down, the provi-sional application will ensure you get an application on file as quickly as possible with the least cost. This allows you to

start having conversations with investors and other potential money sources without the previously discussed concerns about pre-filing disclosure.

Licensing your technologyAlternatively, your patent

strategy may be different if your goal is to license or sell your technology to an existing company. In this case it may make sense to pursue a faster approach with greater upfront costs. From the perspective of a potential licensee or purchaser of your technology, the farther along you are in the patent process, the more valuable your patent portfolio. Thus, it makes sense to file a non-provisional patent application instead of a provisional. A non-provisional application starts the prosecu-tion process—you must file a non-provisional in order to have your application examined and move towards getting a patent. The desire to get an issued pat-ent as quickly as possible may

Intellectual property in medicine to page 34

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Don’t tell anyone about your idea because disclosure can create

significant problems.

Intellectual property in medicine from page 33

very well outweigh the addition-al upfront costs associated with the non-provisional (vs. the provisional).

Your business plans will also influence the depth of any free-dom-to-operate analysis that you may obtain. For example, if you are seeking investment from an angel fund or other sophisticated investor(s), it is highly likely that the investor will want to do a freedom to operate analysis. In that case, your own analysis does not need to be extensive or require a substantial outlay of money. Instead, if you’re hoping for a substantial investment in your venture, you can simply do a more preliminary analysis to confirm that there are no major “red flags” with respect to free-dom to operate. On the other hand, if you’re planning to market and commercialize your own technology, then a more extensive freedom to operate analysis is required.

Patent law basicsNow that your patent strategy is in place, you can turn your attention to filing a patent appli-cation. As discussed earlier, you can file either a provisional (and then a non-provisional within a year) or a non-provi-sional application in the U.S. Regardless of the approach, you will ultimately need to file the non-provisional in order to pursue a patent.

Once you have filed your application, what happens next? Many first-time in-ventors assume that once a non-provisional application is filed, the hard work is done and a patent is on its way. That, however, is not the case. Draft-ing and filing the application

is just the first step. Once the non-provisional application is filed, it is eventually assigned to a patent examiner who will review the application, analyze the claims (which define the in-vention and are the focus of the prosecution of the application), perform a prior art search based on the claims, and then issue an office action to the applicant. In the office action, the examiner takes a position as to the pat-

entability of the claims, among other things. Typically, in the first office action, the examiner will “reject” the claims based on one or more prior art references identified in the prior art search or based on other statutory re-quirements for the claims.

Upon receipt of the office action, you will want to con-sult with your patent attorney and come up with a response strategy. Generally, your main options in responding to the office action are to 1) argue that the claim rejections are incorrect and provide a reasoned explana-tion regarding why the rejections are incorrect and the claims are patentable, 2) amend the claims to overcome the rejections, or 3) both argue and amend the claims. Once you’ve come up with a satisfactory response strategy, your patent attorney will draft and file the response.

This process can repeat itself several times, and it is not un-usual to have multiple rounds of office actions and responses for any given patent application. As of December 2015, the aver-age number of office actions per application was almost 2.5, but I have seen applications that received more than eight office actions. Ultimately, the goal is to present successful arguments and/or amendments that result in the issuance of a patent.

Foreign patent protectionOf course, while you’re

preparing your strategy for your U.S. non-provisional

application, you must also consider whether you want to pursue foreign patent protec-tion. To this point, we have been discussing patent protection mainly in the context of the U.S. Patent Office, but it is equally important to consider your pat-ent strategy outside the United States. If you are planning to pursue foreign patent protec-tion in two or more foreign countries, the simplest, most cost-effective approach is a PCT application, which is an inter-national patent application cre-ated by the Patent Cooperation Treaty that was signed in 1970. This treaty created a unified application and procedure for pursuing a patent application in foreign countries under which an applicant in the U.S. can file the PCT application within a year of the applicant’s first filing (usually the provisional applica-tion). Subsequently you have 30 months from the original filing to enter any foreign jurisdic-tions that are party to the treaty with the same patent applica-tion and preserve the original filing date thereof.

ConclusionThe road from invention to an issued patent is not easy or simple—it is a complex pro-cess that requires determina-tion, effort, and a good patent attorney. On the other hand, if you take the appropriate steps, the patent process gives you an opportunity to protect your ideas and hopefully improve the well-being of your patients.

This article reflects the personal views of the author and is not to be construed as representing in any way the views or advice of the Davis Brown Law Firm. The content is solely for purposes of discussion and illustration, and is not to be considered legal advice.

Sean Solberg, JD, is a shareholder and chair of the IP Department at the Davis Brown Law Firm in Des Moines, IA, where he focus-es mainly on medical device and biotech technologies and works with several physicians and other clients in Minnesota.

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its Quality and Resource Use Report (QRUR). One of the most significant changes is that a provider’s cost composite score will now reflect all health care costs (except Medicare Part D) incurred for the Medi-care beneficiaries attributed to them. Beneficiaries are attributed to a provider by hav-ing received the “plurality” of their services from a particular provider. Providers in specialty clinics have been surprised to learn that they have beneficia-ries attributed to them. One optometry clinic found its cost composite score was impacted by its patients’ hospital stays.

Understanding value- based care

Alternative payment models share a common pathway for success: providers must make fundamental changes in their day-to-day operations that improve the quality and reduce the cost of health care.

Your clinic needs to under-stand more than the data from the QRUR and other quality reports. Educate yourself and all members of your organi-zation about value-based care delivery. Everyone involved in patient care needs to have at least a basic understand-ing about how they impact value. This environment is ever-evolving and it’s become increasingly difficult for one person in an organization to understand and oversee partici-pation in all of the CMS incen-tive programs. Stay on top of changes by having a multi-dis-ciplinary quality team. Orga-nizations that flourish take the time to bring everyone together to help them understand how care management is changing. If you are a solo practice, con-sider networking with others. Education and networking opportunities are available

through Medicare’s 14 Quality Innovation Network-Quality Improvement Organizations (QIN-QIO). The QIN-QIOs bring together providers at the local level for collaborative learning about value-based care.

Tracking and reporting data

Effective quality improvement can’t be done without data. Decide what data you can and will collect to meet the reporting

requirements and help improve care delivery for those mea-sures that apply to you. Decide how often to pull data so it’s meaningful and actionable. These decisions may evolve as you experiment with how to use your data, but you should review data more than annually. In organizations that report via claims, a multi-disciplinary team that includes billing and coding staff will help you reach success. Organizations that have an IT team should invite them to help determine what data you can and will collect, and how reports can be pulled. Part of tracking and reporting data is understanding the capabilities of your EHR. Leverage the knowledge and skills of your IT team and your EHR vendor, and see if your EHR vendor has a user group you can learn from.

Odds are good that a few of your workflows interfere with your organization’s ability to report data to CMS. Every time I’ve done process mapping with an organization, they’ve discovered at least one, if not many, processes are being done independently, outside of their standard processes. Or, one physician may be following a process that is different from another physician in the same practice. Understanding the workflows that everyone uses when it comes to reporting processes offers the opportu-nity to discover inconsistencies and improve workflows. As EHRs are harnessed to more effectively produce meaningful data, more details will be avail-able to inform how to reshape

workflows to improve quality and decrease cost.

Taking advantage of review periods

Finally, challenge CMS when its findings don’t seem right. For example, some solo prac-titioners received negative payment adjustment notifica-tions in their QRURs for VBM; however, solo practitioners are not eligible for a negative payment adjustment for 2016. CMS offers annual informal review periods for both PQRS reporting and VBM. This is the only mechanism for challenging findings you don’t agree with and potentially reversing neg-ative payment adjustments. In 2014, some eligible profession-als were not able and/or eligible to report PQRS data. For those providers who submitted a request for an Informal Review, CMS reversed the negative pay-ment adjustment.

Success by aligning with value

Your team members might feel like Sisyphus, starting over each time the incentive pro-grams evolve. As your practice makes changes to stay vital during this time of health-care delivery transformation, you will find areas that need improvement. You also will find where your patient care has improved or you’ve provided more cost effective service than your peers. Celebrate what your organization is doing well, and focus on the reason for payment reforms. Organizations who align their missions with value will be the ones most ready to maximize Medicare payments and improve patient outcomes through MIPS in 2019.

Candy Hanson, BSN, PHN, is a program manager at Stratis Health. As a certified practice facilitator, she helps physicians and clinics understand and succeed in the EHR Incentive Program, PQRS, Value-Based Modifier Program, and MIPS, to make lives better for Medicare beneficiaries. She works with the health care community to achieve Medicare’s quality improvement goals in Minnesota through Lake Superior Quality Innovation Network.

Challenge CMS when its findings don’t

seem right.


Maximizing Medicare payments from page 24

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perception that the physician is “dumping” bad news on the patient by stating facts and im-mediately departing. When cal-culating the expected duration of the visit, physicians should recognize that patients receiv-ing bad news would likely need time to process the information they are receiving.

Over time, every physician will find the “best” way to deliver bad news, with certain components tailored to the needs of individual patients. In particular, cultural competency is necessary, as patients from different cultures may have varying expectations of the phy-sician/patient interaction and the involvement of family mem-bers and friends. Because bad news is most often serious and life altering, the onus falls on the physician to assess patient readiness, provide information and check for understanding, provide empathic emotional support, and identify (with the patient) the next step in care.

Physicians may find the six-step SPIKES protocol useful as a template to deliver bad news (Baile, Buckman, & Lenzi, 2000). The six steps are:

1. Setting up the interview

2. Assessing the patient’s Perception

3. Obtaining the patient’s Invitation to proceed further with the discussion

4. Giving Knowledge and information to the patient

5. Addressing the patient’s Emotions with Empathic responses

6. Strategy and Summary

Although not every bad news encounter will require that all the steps be followed, this use-ful framework helps clinicians organize what is often a stress-ful encounter for both provider and patient.

Honesty is bestPhysicians are ethically and legally mandated to share information with patients about

health care that would change patient outcomes. Published data suggest that the over-whelming majority of patients wish to be included in these dis-cussions. In rare cases, patients may explicitly request to receive limited or no bad news regarding their health status; these cases are extraordinarily rare and their management should be in accordance with a contract of care between the physician and patient. Prior to deciding that a patient will not receive bad news, the physician and patient should extensively discuss patient expectations and goals for care. If the phy-sician believes that these goals are clinically reasonable and achievable, then the physician and patient must discuss the relative and absolute risks and benefits of limiting the deliv-ery of bad news. Shared deci-sion-making is imperative in this setting, particularly when fear or other emotions, or the presence of other perceived stakeholders (such as children

or spouses) may preclude patients from making a fully informed choice not to know. In particularly challenging cases, consulting an ethicist may be appropriate.

ConclusionIn summary, while neither physicians nor patients enjoy a discussion about bad news, these conversations can be held in a sensitive and respectful manner that enables the patient to retain his or her autonomy and be actively involved in planning the next steps in care. Clinicians should be careful to practice communication skills related to bad news delivery, including eliciting patient health priorities and personal and cultural preferences.

Kathleen Kieran, MD, MS, is an associate professor of urology at the University of Washington and Seattle Children’s Hospital. She has a special interest in communication skill teaching and development in surgical subspecialty trainees.

Breaking bad news from page 29

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What are patients and doctors to

make of the bevy of acronyms

that seem to increase daily?

HMO (health maintenance organization)

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federal Independent Payment Advisory

Board)? Recently, huge health insurance

corporation mega-mergers have been fea-

tured in the news. Flying below the radar

are mini-mergers between ACOs (hospi-

tal/medical staff insurance corporations)

and HMOs. What happened, what’s going

on, and how do all these things work…or

not work?

Political

malpractice

A look at medical costs

By Robert W. Geist, MD

Infectious disease

The value of physician reports

By Richard Danila, PhD, MPH, and Ruth Lynfield, MD 6S

urveillance for infectious dis-

eases is a core public health

function essential to prevention

fforts. Since early in its

h Minneso-

virus disease, or other infectious dis-

ease is there in Minnesota? What are

the trends in these or other diseases

over time? Are the numbers increasing

or decreasing, and how are the char-

acteristics of the cases and patients

i g? What are the risk factors or

for the cases? This

inform

Political malpractice to page 18

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

Protection and Affordable Care Act),

which may be easily confused with ACOs

(Accountable Care Organizations), one of

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-

tured in the news. Flying below the radar

are mini-mergers between ACOs (hospi-

tal/medical staff insurance corporations)

and HMOs. What happened, what’s going

on, and how do all these things work…or

not work?

Political

malprmalprma p acticact e

A look at medical costs

By Robert W. Geist, MD

IIInnfnfefecn tious disease

The value of physician reports

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

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

hich states that all hospitals

an

Leveraging

information

technology

A look at EHR data

By Bob Johnson, MPP, and

Karen Soderberg, MS


believing that someone will heal them by expelling the force affecting them. Soma-lis may be unaccustomed to the idea that talking (psychotherapy) can remedy anything or that they can learn skills that will enable them to heal themselves.

5. Many refugees might attribute their depres-sion or anxiety to a psychosocial stressor such as a lack of hous-ing or employment, which may seem more imperative to them than the deteriora-tion of their mental health. They believe that if stressors are removed they will feel better, not knowing that the illness will remain whether or not they find housing.

Suggestions for culturally responsive treatment

Clinicians will be better able to help East African patients if

they learn about the patient’s culture—the values and beliefs of their native environments that impact day-to-day think-ing, behaviors, and emotions. Clinicians should explore the resources their clients bring to the session and incorporate some of them in the treatment.

For example, instead of intro-ducing a relaxation technique the client is not familiar with, the clinician can explore relax-ation techniques used in the client’s culture. Relating thera-peutic interventions to concepts and practices familiar to the cli-ent helps the client understand the intervention and gives him or her a sense of ownership of the treatment.

Psychoeducation is one way to address the discrepancy

between the Western and Afri-can concepts of mental illness. Clients can be overwhelmed if a lot of new materials and con-cepts are introduced without some foundation for relating to them. It is important to educate African clients about diagnoses and therapeutic interventions

to help them understand the importance of practicing them. For example, explaining the connection between early child-hood trauma and current symp-toms encourages clients to talk about their past experiences.

It is important to help So-mali clients understand what is at stake if mental illness is ignored. They have to address these conditions because the U.S. requires a different level of functioning than their country

of origin did. One has to be ful-ly functioning to do well here, unlike in refugee camps where people were more or less at the same level and there were no opportunities for advancement. In America, immigrants are ex-pected, among other things, to learn a new language, negotiate

an unfamiliar bureau-cracy, and compete with native-born citizens.

Understanding the beliefs and practices of the country of origin, recognizing and address-ing the obstacles that

prevent seeking treatment, and incorporating familiar cultural practices into clients’ therapy when possible can encourage clients to accept mental health services more readily and lead to improved outcomes.

Ahmed M. Hassan, MA, LPCC, is a psychotherapist who directs Summit Guidance, with clinics in Saint Paul and Moorhead.

It is important to help Somali clients understand what is at stake if mental illness is ignored.

East African culture and mental health from page 31

PHYSICIANS/FAMILYLL NURSE PRACTITIONERS/PHYSICIAN ASSISTATT NTS:

What if woww rkwaww s whererr yoyy uweww nt to tt rerr ch

yargrr e?

MARATHON HEALTH IS AN EQUAL OPPORTUNITY EMPLOYER

Do you know what it feels like to work with a senseof 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 (20hrs/week) Family Nurse Practitioner or Physician Assistant and a part-time (8hrs/week) Family Physician to work with employees and their families (newborns +). 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.

The perfect matchof career and lifestyle.

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


plans, leaving the remainder divided among different areas of the state and receiving their care from a multitude of small and large providers. An additional marketplace challenge is the relative efficiency of our Minnesota providers in comparison to their national peers. In the case of IHN, this signifi-cantly lowered the savings benchmark targets we worked so hard to achieve, which makes it even harder to cross the savings threshold CMS applies to each ACO. Our benchmark was thousands less than our larger health system competition.

Critical access hospitals, and actually hospitals overall, rep-resent a challenge that is shared by the ACO and the hospitals themselves. Some of the areas of greatest potential savings are inpatient and outpatient costs as well as medically unneces-sary admissions, readmissions,

and emergency department vis-its. This is, however, compelling good dialogue between hospi-tals and ACOs, particularly in rural areas.

TechnologyWe’ve had to find ways to

adapt to the unique culture of independent practices that make up our ACO—we have over 24 different electronic health record systems installed. We have had to make the leap to a data warehouse platform that allows us to bridge to a multitude of practice systems as well as to other types of vendors such as our reference labs. Care coordination is handled by our clinics directly so our challenge

has been to find a platform for training clinic staffs, and doc-umenting and tracking coordi-nation activities, while ensuring a consistency of efforts across our network.

IT-related solutions are be-ing employed in almost all ACO settings—from web-based edu-cation to text or email remind-ers to apps and programs that raise patient engagement. Data analytics is crucial and at vari-ous stages of implementation of dashboards. This is an attempt to deliver critical information in a timely manner to physicians without inundating them with the mountains of data we now receive from CMS.

ConclusionThe ACO concept is helping redesign the model of health care delivery across the coun-try. Lessons learned from our involvement as an ACO have

been many and invaluable to our organization’s efforts at multiple levels. They have also served to rein-force a basic tenet we have held since our inception. High-quality care does not have to be high-cost care; more accurately high-qual-ity care is usually less expensive. Our primary

focus as an organization of independent providers contin-ues to be providing quality care to our patients. Secondarily, we strive to do so at a reasonable cost and, as our data demon-strates, one does complement the other.

Bruce Penner, RN, is vice president of Population Health at Integrity Health Network. Jeffrey L. Tucker is president and CEO of Integrity Health Network.

Making an ACO work from page 17

There are administrative

burdens to operating an ACO.

Welcome to Boynton Health Service Physician

612-626-1184, [email protected]

and 306981

Boynton Health ServiceA Diverse and Vital Health Servicel


ENTRESTO™ (sacubitril and valsartan) tablets, for oral useInitial U.S. Approval: 2015

BRIEF SUMMARY: Please see package insert for full prescribing information.

1 INDICATIONS AND USAGE1.1 Heart FailureENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHAClass II-IV) and reduced ejection fraction.

ENTRESTO is usually administered in conjunction with other heart failuretherapies, in place of an ACE inhibitor or other ARB.

4 CONTRAINDICATIONS ENTRESTO is contraindicated: • in patients with hypersensitivity to any component• in patients with a history of angioedema related to previous ACE inhibitor

or ARB therapy [see Warnings and Precautions (5.2)]• with concomitant use of ACE inhibitors. Do not administer within 36 hours

of switching from or to an ACE inhibitor [see Drug Interactions (7.1)] • with concomitant use of aliskiren in patients with diabetes [see Drug

Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS5.1 Fetal Toxicity ENTRESTO can cause fetal harm when administered to a pregnant woman.Use of drugs that act on the renin-angiotensin system during the secondand third trimesters of pregnancy reduces fetal renal function and increasesfetal and neonatal morbidity and death. When pregnancy is detected, con-sider alternative drug treatment and discontinue ENTRESTO. However, ifthere is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother,advise a pregnant woman of the potential risk to the fetus [see Use in Specific Populations (8.1)].

5.2 AngioedemaENTRESTO may cause angioedema. In the double-blind period of PARADIGM-HF, 0.5% of patients treated with ENTRESTO and 0.2% ofpatients treated with enalapril had angioedema [see Adverse Reactions(6.1)]. If angioedema occurs, discontinue ENTRESTO immediately, provideappropriate therapy, and monitor for airway compromise. ENTRESTO mustnot be re-administered. In cases of confirmed angioedema where swellinghas been confined to the face and lips, the condition has generally resolvedwithout treatment, although antihistamines have been useful in relievingsymptoms.

Angioedema associated with laryngeal edema may be fatal. Where there isinvolvement of the tongue, glottis or larynx, likely to cause airway obstruc-tion, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1000 (0.3 mL to 0.5 mL) and take measures neces-sary to ensure maintenance of a patent airway.

ENTRESTO has been associated with a higher rate of angioedema in Blackthan in non-Black patients.

Patients with a prior history of angioedema may be at increased risk ofangioedema with ENTRESTO [see Adverse Reactions (6.1)]. ENTRESTOshould not be used in patients with a known history of angioedema relatedto previous ACE inhibitor or ARB therapy [see Contraindications (4)].

5.3 HypotensionENTRESTO lowers blood pressure and may cause symptomatic hypoten-sion. Patients with an activated renin-angiotensin system, such as volume-and/or salt-depleted patients (e.g., those being treated with high doses ofdiuretics), are at greater risk. In the double-blind period of PARADIGM-HF,18% of patients treated with ENTRESTO and 12% of patients treated withenalapril reported hypotension as an adverse event [see Adverse Reactions(6.1)], with hypotension reported as a serious adverse event in approxi-mately 1.5% of patients in both treatment arms. Correct volume or saltdepletion prior to administration of ENTRESTO or start at a lower dose. Ifhypotension occurs, consider dose adjustment of diuretics, concomitantantihypertensive drugs, and treatment of other causes of hypotension (e.g.,hypovolemia). If hypotension persists despite such measures, reduce thedosage or temporarily discontinue ENTRESTO. Permanent discontinuationof therapy is usually not required.

5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system(RAAS), decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO. In the double-blind period of PARADIGM-HF, 5% of patients in both the ENTRESTO and enalapril groups

reported renal failure as an adverse event [see Adverse Reactions (6.1)]. In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heartfailure), treatment with ACE inhibitors and angiotensin receptor antagonistshas been associated with oliguria, progressive azotemia and, rarely, acuterenal failure and death. Closely monitor serum creatinine, and down-titrateor interrupt ENTRESTO in patients who develop a clinically significantdecrease in renal function [see Use in Specific Populations (8.7) and Clini-cal Pharmacology (12.3) in the full prescribing information].

As with all drugs that affect the RAAS, ENTRESTO may increase blood ureaand serum creatinine levels in patients with bilateral or unilateral renalartery stenosis. In patients with renal artery stenosis, monitor renal function.

5.5 HyperkalemiaThrough its actions on the RAAS, hyperkalemia may occur with ENTRESTO.In the double-blind period of PARADIGM-HF, 12% of patients treated withENTRESTO and 14% of patients treated with enalapril reported hyperkalemiaas an adverse event [see Adverse Reactions (6.1)]. Monitor serum potassiumperiodically and treat appropriately, especially in patients with risk factorsfor hyperkalemia such as severe renal impairment, diabetes, hypoaldoster-onism, or a high potassium diet. Dosage reduction or interruption ofENTRESTO may be required [see Dosage and Administration (2.1) in thefull prescribing information].

6 ADVERSE REACTIONSClinically significant adverse reactions that appear in other sections of thelabeling include:• Angioedema [see Warnings and Precautions (5.2)]• Hypotension [see Warnings and Precautions (5.3)]• Impaired Renal Function [see Warnings and Precautions (5.4)]• Hyperkalemia [see Warnings and Precautions (5.5)]

6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions,adverse reaction rates observed in the clinical trials of a drug cannot bedirectly compared to rates in the clinical trials of another drug and may notreflect the rates observed in practice.

In the PARADIGM-HF trial, subjects were required to complete sequentialenalapril and ENTRESTO run-in periods of (median) 15 and 29 days,respectively, prior to entering the randomized double-blind period comparingENTRESTO and enalapril. During the enalapril run-in period, 1,102 patients(10.5%) were permanently discontinued from the study, 5.6% because ofan adverse event, most commonly renal dysfunction (1.7%), hyperkalemia(1.7%) and hypotension (1.4%). During the ENTRESTO run-in period, anadditional 10.4% of patients permanently discontinued treatment, 5.9%because of an adverse event, most commonly renal dysfunction (1.8%),hypotension (1.7%) and hyperkalemia (1.3%). Because of this run-indesign, the adverse reaction rates described below are lower than expectedin practice.

In the double-blind period, safety was evaluated in 4,203 patients treatedwith ENTRESTO and 4,229 treated with enalapril. In PARADIGM-HF, patientsrandomized to ENTRESTO received treatment for up to 4.3 years, with amedian duration of exposure of 24 months; 3,271 patients were treated formore than one year. Discontinuation of therapy because of an adverse eventduring the double-blind period occurred in 450 (10.7%) of ENTRESTOtreated patients and 516 (12.2%) of patients receiving enalapril.

Adverse reactions occurring at an incidence of ≥5% in patients who weretreated with ENTRESTO in the double-blind period are shown in Table 1.

Table 1: Adverse Reactions Reported in ≥5% of Patients Treated withENTRESTO in the Double-Blind Period

ENTRESTO Enalapril(n = 4,203) (n = 4,229)

% %

Hypotension 18 12

Hyperkalemia 12 14

Cough 9 13

Dizziness 6 5

Renal failure/acute renal failure 5 5

In the PARADIGM-HF trial, the incidence of angioedema was 0.1% in boththe enalapril and ENTRESTO run-in periods. In the double-blind period, theincidence of angioedema was higher in patients treated with ENTRESTOthan enalapril (0.5% and 0.2%, respectively). The incidence of angioedemain Black patients was 2.4% with ENTRESTO and 0.5% with enalapril [seeWarnings and Precautions (5.2)].

Orthostasis was reported in 2.1% of patients treated with ENTRESTO com-pared to 1.1% of patients treated with enalapril during the double-blindperiod of PARADIGM-HF. Falls were reported in 1.9% of patients treatedwith ENTRESTO compared to 1.3% of patients treated with enalapril.

WARNING: FETAL TOXICITY• When pregnancy is detected, discontinue ENTRESTO as soon as possi-

ble (5.1)• Drugs that act directly on the renin-angiotensin system can cause injury

and death to the developing fetus (5.1)


Laboratory AbnormalitiesHemoglobin and HematocritDecreases in hemoglobin/hematocrit of >20% were observed in approxi-mately 5% of both ENTRESTO- and enalapril-treated patients in the double-blind period in PARADIGM-HF.

Serum Creatinine Increases in serum creatinine of >50% were observed in 1.4% of patients in the enalapril run-in period and 2.2% of patients in the ENTRESTO run-in period. During the double-blind period, approximately 16% of bothENTRESTO- and enalapril-treated patients had increases in serum creatinineof >50%.

Serum PotassiumPotassium concentrations >5.5 mEq/L were observed in approximately 4%of patients in both the enalapril and ENTRESTO run-in periods. During thedouble-blind period, approximately 16% of both ENTRESTO- and enalapril-treated patients had potassium concentrations >5.5 mEq/L.

7 DRUG INTERACTIONS7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone SystemConcomitant use of ENTRESTO with an ACE inhibitor is contraindicatedbecause of the increased risk of angioedema [see Contraindications (4)].

Avoid use of ENTRESTO with an ARB, because ENTRESTO contains theangiotensin II receptor blocker valsartan.

The concomitant use of ENTRESTO with aliskiren is contraindicated inpatients with diabetes [see Contraindications (4)]. Avoid use with aliskirenin patients with renal impairment (eGFR <60 mL/min/1.73 m²).

7.2 Potassium-Sparing DiureticsAs with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene,amiloride), potassium supplements, or salt substitutes containing potassiummay lead to increases in serum potassium [see Warnings and Precautions(5.5)].

7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)In patients who are elderly, volume-depleted (including those on diuretictherapy), or with compromised renal function, concomitant use of NSAIDs,including COX-2 inhibitors, with ENTRESTO may result in worsening ofrenal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically.

7.4 LithiumIncreases in serum lithium concentrations and lithium toxicity have beenreported during concomitant administration of lithium with angiotensin IIreceptor antagonists. Monitor serum lithium levels during concomitant usewith ENTRESTO.

8 USE IN SPECIFIC POPULATIONS8.1 PregnancyRisk SummaryENTRESTO can cause fetal harm when administered to a pregnant woman.Use of drugs that act on the renin-angiotensin system during the secondand third trimesters of pregnancy reduces fetal renal function and increasesfetal and neonatal morbidity and death. Most epidemiologic studies examin-ing fetal abnormalities after exposure to antihypertensive use in the firsttrimester have not distinguished drugs affecting the renin-angiotensin sys-tem from other antihypertensive agents. In animal reproduction studies,ENTRESTO treatment during organogenesis resulted in increased embryo-fetal lethality in rats and rabbits and teratogenicity in rabbits. When preg-nancy is detected, consider alternative drug treatment and discontinueENTRESTO. However, if there is no appropriate alternative to therapy withdrugs affecting the renin-angiotensin system, and if the drug is consideredlifesaving for the mother, advise a pregnant woman of the potential risk tothe fetus.

The estimated background risk of major birth defects and miscarriage forthe indicated population is unknown. In the U.S. general population, theestimated background risk of major birth defects and miscarriage in clini-cally recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical ConsiderationsFetal/Neonatal Adverse ReactionsOligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy canresult in the following: reduced fetal renal function leading to anuria andrenal failure, fetal lung hypoplasia, skeletal deformations, including skullhypoplasia, hypotension, and death.

Perform serial ultrasound examinations to assess the intra-amniotic envi-ronment. Fetal testing may be appropriate, based on the week of gestation.Patients and physicians should be aware, however, that oligohydramniosmay not appear until after the fetus has sustained irreversible injury. Ifoligohydramnios is observed, consider alternative drug treatment. Closelyobserve neonates with histories of in utero exposure to ENTRESTO forhypotension, oliguria, and hyperkalemia. In neonates with a history of

in utero exposure to ENTRESTO, if oliguria or hypotension occurs, supportblood pressure and renal perfusion. Exchange transfusions or dialysis maybe required as a means of reversing hypotension and replacing renal function.

DataAnimal DataENTRESTO treatment during organogenesis resulted in increased embryo-fetal lethality in rats at doses ≥ 49 mg sacubitril/51 mg valsartan/kg/day (≤ 0.14 [LBQ657, the active metabolite] and 1.5 [valsartan]-fold the maxi-mum recommended human dose [MRHD] of 97/103 mg twice-daily on thebasis of the area under the plasma drug concentration-time curve [AUC])and rabbits at doses ≥ 5 mg sacubitril/5 mg valsartan/kg/day (4-fold and0.06-fold the MRHD on the basis of valsartan and LBQ657 AUC, respec-tively). ENTRESTO is teratogenic based on a low incidence of fetal hydro-cephaly, associated with maternally toxic doses, which was observed inrabbits at an ENTRESTO dose of ≥ 5 mg sacubitril/5 mg valsartan/kg/day.The adverse embryo-fetal effects of ENTRESTO are attributed to theangiotensin receptor antagonist activity.

Pre- and postnatal development studies in rats at sacubitril doses up to 750 mg/kg/day (4.5-fold the MRHD on the basis of LBQ657 AUC) and valsartan at doses up to 600 mg/kg/day (0.86-fold the MRHD on the basisof AUC) indicate that treatment with ENTRESTO during organogenesis, gestation and lactation may affect pup development and survival.

8.2 LactationRisk SummaryThere is no information regarding the presence of sacubitril/valsartan inhuman milk, the effects on the breastfed infant, or the effects on milk pro-duction. Sacubitril/valsartan is present in rat milk. Because of the potentialfor serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommendedduring treatment with ENTRESTO.

DataFollowing an oral dose (15 mg sacubitril/15 mg valsartan/kg) of [14C] ENTRESTO to lactating rats, transfer of LBQ657 into milk wasobserved. After a single oral administration of 3 mg/kg [14C] valsartan tolactating rats, transfer of valsartan into milk was observed.

8.4 Pediatric UseSafety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use No relevant pharmacokinetic differences have been observed in elderly(≥65 years) or very elderly (≥75 years) patients compared to the overallpopulation [see Clinical Pharmacology (12.3) in the full prescribing information].

8.6 Hepatic ImpairmentNo dose adjustment is required when administering ENTRESTO to patientswith mild hepatic impairment (Child-Pugh A classification). The recommendedstarting dose in patients with moderate hepatic impairment (Child-Pugh Bclassification) is 24/26 mg twice daily. The use of ENTRESTO in patientswith severe hepatic impairment (Child-Pugh C classification) is not recom-mended, as no studies have been conducted in these patients [see Dosageand Administration (2.4) in the full prescribing information, Clinical Phar-macology (12.3) in the full prescribing information].

8.7 Renal ImpairmentNo dose adjustment is required in patients with mild (eGFR 60 to 90 mL/min/1.73 m2) to moderate (eGFR 30 to 60 mL/min/1.73 m2) renalimpairment. The recommended starting dose in patients with severe renalimpairment (eGFR <30 mL/min/1.73 m2) is 24/26 mg twice daily [seeDosage and Administration (2.3) in the full prescribing information, Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) in thefull prescribing information].

10 OVERDOSAGELimited data are available with regard to overdosage in human subjectswith ENTRESTO. In healthy volunteers, a single dose of ENTRESTO 583 mgsacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mgvalsartan (14 days) have been studied and were well tolerated.

Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of ENTRESTO. Symptomatic treatment should beprovided.

ENTRESTO is unlikely to be removed by hemodialysis because of high pro-tein binding.

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936

© Novartis

T2015-100

ENTRESTO is a trademark of Novartis AG

Issued: July/2015

WARNING: FETAL TOXICITY• When pregnancy is detected, discontinue ENTRESTO as soon as possible• Drugs that act directly on the renin-angiotensin system can cause injury and death

to the developing fetus

ENTRESTO is contraindicated in patients with hypersensitivity to any component. ENTRESTO iscontraindicated in patients with a history of angioedema related to previous angiotensin-convertingenzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy.ENTRESTO is contraindicated with concomitant use of ACE inhibitors. Do not administer within 36 hoursof switching from or to an ACE inhibitor. ENTRESTO is contraindicated with concomitant use of aliskirenin patients with diabetes.Angioedema: ENTRESTO may cause angioedema. Angioedema associated with laryngeal edema may befatal. ENTRESTO has been associated with a higher rate of angioedema in Black patients and in patientswith a prior history of angioedema. If angioedema occurs, discontinue ENTRESTO immediately, provideappropriate therapy, and monitor for airway compromise. ENTRESTO must not be re-administered.Hypotension: ENTRESTO lowers blood pressure and may cause symptomatic hypotension. Patientswith an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., thosebeing treated with high doses of diuretics), are at greater risk. Correct volume or salt depletion prior toadministration of ENTRESTO or start at a lower dose. If hypotension persists despite dose adjustmentof diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g.,hypovolemia) reduce the dosage or temporarily discontinue ENTRESTO. Permanent discontinuation oftherapy is usually not required.Impaired Renal Function: Decreases in renal function may be anticipated in susceptible individualstreated with ENTRESTO. In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACEinhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemiaand, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt

ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateralrenal artery stenosis. In patients with renal artery stenosis, monitor renal function. Avoid use with aliskiren in patients with renal impairment (eGFR <60 mL/min/1.73 m2).In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised

inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure.

These effects are usually reversible. Monitor renal function periodically.Hyperkalemia: Hyperkalemia may occur with ENTRESTO. Monitor serum potassium periodically and treatappropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment,diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of ENTRESTOmay be required.Concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassiumsupplements, or salt substitutes containing potassium may lead to increases in serum potassium.ARBs: Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan.Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported duringconcomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithiumlevels during concomitant use with ENTRESTO.Common Adverse Events: In a clinical trial, the most commonly observed adverse events with ENTRESTOvs enalapril, occurring at a frequency of at least 5% in either group, were hypotension (18%, 12%),hyperkalemia (12%, 14%), cough (9%, 13%) dizziness (6%, 5%) and renal failure/acute renal failure(5%, 5%).Please see Brief Summary of Prescribing Information, including Boxed WARNING,on following pages.

STUDY DESIGN: PARADIGM-HF was a multinational, randomized, double-blind trial comparingENTRESTO to enalapril in 8442 symptomatic (NYHA class II–IV) adult HFrEF patients (left

entered sequential single-blind run-in periods during which they received enalapril 10 mg twicedaily, followed by ENTRESTO 100 mg (49/51 mg) twice daily, increasing to 200 mg (97/103 mg)twice daily. Patients were then randomized to receive either ENTRESTO 200 mg (97/103 mg)(n=4209) twice daily or enalapril 10 mg (n=4233) twice daily. The median follow-up duration was

1

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor blocker; HFrEF=heart failurewith reduced ejection fraction; CV=cardiovascular; NYHA=New York Heart Association; HF=heart failure.

For more information, visit EntrestoHCP.com

REDUCED RISK OFCV DEATH OR FIRSTHF HOSPITALIZATIONVS ENALAPRIL1

Use ENTRESTO™ in place of ACEis and ARBs for HFrEF patients1

ENTRESTO was studied in the largest HF trial ever conducted2

•the primary end point being met3

ENTRESTO has been proven superior to enalapril, a current standard-of-care4 medication1

• Superiority vs enalapril, a standard-of-care ACEi therapy, across a rangeof NYHA class II–IV patients with chronic HF and reduced ejection fraction

REDEFINE EXPECTATIONS IN HEART FAILURE

ABSOLUTE RISKREDUCTION1

P<0.0001 HR (95% CI): 0.80 (0.73, 0.87)

INDICATIONENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.ENTRESTO is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.

IMPORTANT SAFETY INFORMATION

References: 1. ENTRESTO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2015. 2. McMurray JJV, Packer M, Desai AS, et al. Baseline characteristics and treatment of patients inProspective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail. 2014;16(7):817-825. 3. McMurray JJV, Packer M, Desai AS, et al.Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004. 4. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report ofthe American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128(16):e240-e327.

ENTRESTO is a trademark of Novartis AG.

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 © 2015 Novartis 12/15 ETR-1321796

mn physician mar 2016

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