MN Physician Mar 2016 by Minnesota Physician Publishing

Vo l u m e X X I X , N o . 12 M a r c h 2 016

Minnesota Medicaid ACO initiative Integrated Health Partnerships By Nathan Moracco

n 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 groundbreaking initiative in Minnesota’s Medicaid program called the Integrated Health Partnerships (IHP). According to Aidoo-Abrahams, “Patients need help and support to navigate the health care system.”

Making an ACO work Signs of success By Bruce Penner, RN, and Jeffrey L. Tucker

Improving quality of care Started 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 professions such as community health workers and community paramedics are important. Minnesota Medicaid ACO initiative to page 18

ealth care providers have been working with shared savings in one form or another 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 rewards across our network to enhance independent medicine. The Integrity Health Foundation, an affiliated 501(c)3 non-profit organization, has also made investments in independent medicine’s future—including the 2014 launch of our Medicare Shared Making an ACO work to page 16

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MARCH 2016 • VOLUME XXIX, NUMBER 12

MINNESOTA HEALTH CARE ROUNDTABLE

FEATURES Making an ACO work Signs of success

By Bruce Penner, RN, and Jeffrey L. Tucker

FORTY-FIFTH SESSION

Minnesota Medicaid ACO initiative Integrated Health Partnerships By Nathan Moracco

DEPARTMENTS CAPSULES

10 CARDIOLOGY

MEDICUS

INTERVIEW

A new ecosystem for health

HEALTH DISPARITIES

Medical Innovation vs. Medical Economics Ecconomics When payment policies limit quality of life

East African culture and mental health By Ahmed M. Hassan, MA, LPCC

Douglas L. Wood, MD, FACP, FACC Center for Innovation at Mayo Clinic

ELECTRONIC HEALTH RECORDS

Radial access By Carmelo J. Panetta, MD

The Electronic Prior Authorization Mandate By Perry Lewis

MEDICINE AND THE LAW

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

SPECIAL FOCUS: OUTCOME-DRIVEN REIMBURSEMENT Maximizing Medicare 24 payments By Candy Hanson, BSN, PHN

Health literacy By Mick Hawton

PROFESSIONAL UPDATE: MEDICAL ETHICS Breaking bad news By Kathleen Kieran, MD, MS

Thursday, April 21, 2016 • 1:00-4:00 PM

Intellectual property in medicine By Sean Solberg, JD

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 Program Sponsors include: Tristate Brain and Spine Institute

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MARCH 2016 MINNESOTA PHYSICIAN

MINNESOTA PHYSICIAN MARCH 2016

It clicked when my doctor and I discussed Trulicity 速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 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

MARCH 2016 MINNESOTA PHYSICIAN

Unbeaten A1C reduction* across 6 head-to-head trials 1,3

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

Add-on to metformin (26 weeks)

Add-on to metformin (52 weeks)

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

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

Compared to Victoza®3

Compared to Januvia®1,5,6

Compared to Byetta®1,7

Compared to Lantus®1,8-10

Mean A1C change from baseline (%)

0.0 -0.2 -0.4

-0.39

-0.6

-0.46 -0.63

-0.8 -1.0

-0.87

-1.2

-0.99

-1.10

-1.4

-1.51

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

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

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

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

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

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

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

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

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

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

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

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

Data represent least-squares mean ± standard error.

•

-1.08

-1.30

-1.36 -1.42

-1.6

-0.76

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

• 104-week, randomized, placebo-

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

• Primary objective was to demonstrate

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

• 78-week, randomized, open-label

•

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

• Primary objective was to demonstrate

•

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

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

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 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

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

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

MINNESOTA PHYSICIAN MARCH 2016

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

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

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

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

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

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

PP-DG-US-0393

01/2016

MARCH 2016 MINNESOTA PHYSICIAN

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

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

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

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

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

TrulicityTM (dulaglutide)

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

MINNESOTA PHYSICIAN MARCH 2016

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

DG HCP BS 20APR2015

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

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

DG HCP BS 20APR2015

MARCH 2016 MINNESOTA PHYSICIAN

CAPSULES

Minnesota Makes Progress on Some Adverse Health Events There 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 number is up slightly from last year’s report, which showed 308 reported adverse health events. Of the 316 reported events, 30 percent (93 cases) resulted in serious 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 pressure 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. Medication 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 Ehlinger, MD, Minnesota commissioner of health. “Our approach of openness and public reporting is helping to encourage overall improvements and new opportunities 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 completion of the Minnesota Time Out process for every patient every time; and implementing standardized processes for specimen collection and transport to prevent biological specimen loss or damage.

FDA Approves Medtronic’s MRI-Safe Defibrillator Medtronic has received approval from the U.S. Food and Drug Administration to sell its implantable resynchronization defibrillator that’s safe to use around magnetic 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 therapy device (CRT-D) to treat heart failure could not undergo MRI scans due to a potential interaction between the MRI and the device 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 experience 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.

MINNESOTA PHYSICIAN MARCH 2016

U of M Opens New Patient-Centered Clinics and Surgery Center The 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 Minnesota Medical Center outpatient clinics located in the Phillips-Wangensteen Building, Mayo Building, Masonic Memorial Building, and West Bank locations moved into the new space to create a more collaborative care environment. “The technology is state-ofthe-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 providers 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 appointment information, gives them a real-time location-monitoring 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 building this facility was to eliminate those triggers,” said Mary Johnson, CEO of M Health. “The personal interaction, convenient clinic arrangements, even the colors 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 workspaces, with the intent of increasing collaboration on care delivery and increasing space efficiency. In addition, it houses a dedicated research liaison to discuss potential 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 platform developed by the University of Minnesota’s Clinical and Translational 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 Jackson, 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 efforts to improve care and achieve breakthroughs.”

Three New Providers Join DHS’ Integrated Health Partnerships Initiative The Minnesota Department of Human Services (DHS) has announced that three new provider groups have joined its Integrated Health Partnerships (IHP) initiative, 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 Children’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 expanding its participation to include its affiliate partners and clinics. “Our nation-leading Integrated Health Partnerships initiative shows that it’s possible to lower the cost of care while maintaining 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 initiative and comparable value-based reforms to half of all Medical Assistance enrollees (about 500,000 people) by the end of 2018. Capsules to page 12

is for Care, Transformed. The new Clinics and Surgery Center is now open.

M Health is transforming Minnesota health care. Now your patients can see a wide range of specialists at one convenient location, with easy check-in and check-out, and stress-free valet parking. There’s nothing else like it. 909 Fulton Street SE, Minneapolis Learn more at MHealth.org/csc A collaboration between University of Minnesota Physicians and University of Minnesota Medical Center.

MARCH 2016 MINNESOTA PHYSICIAN

Capsules from page 11

Health Organizations Announce Action Plan to Improve Health Literacy in Minnesota A coalition of health organizations 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 Education. 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 representatives 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 improve 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 information to make it more understandable by eliminating jargon; making health information easily accessible and presenting it in a variety of mediums; increasing and improving health care professionals’ patient resources to make it easy to share in care services in person, by phone, or online; implementing and enhancing education opportunities in primary, secondary, and professional education; 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 resources 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 partner relations at Portico Healthnet. “Translating the strategies outlined 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 reconvene 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 MNsure MNsure has surpassed its enrollment goal for the first time after two years of falling short of expectations.

As of Feb. 1, 85,390 Minnesotans 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 insurance 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 number of new enrollees nationwide, according to MNsure. In addition, preliminary numbers show that 33,333 Minnesotans newly enrolled in MinnesotaCare; 73,173 newly enrolled 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.”

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MEDICUS Vadim Gurvich, PhD, MBA, research associate professor of medicinal chemistry at the University 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 Vadim Gurvich, associate director of NIPTE since the organiPhD, MBA 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 Minnesota 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 Debra Peterson, honored for putting evidence-based medicine MD into practice by establishing recommendations, workflows, and physician education to achieve high quality outcomes. She earned her medical degree at the University 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 Rachelle Schultz, management. At Winona Health, she oversees MHA 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 University of Minnesota. She serves on the Institute for Clinical Systems Improvement (ICSI) board, is a board director for the Minnesota 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 Department of Health and Human Services and the administrator of CMS on two key areas. In Kenneth Flowe, addition to serving as CMO at Rice Memorial MD Hospital, Flowe is also a practicing emergency physician and medical director of the hospital’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.

Physician Driven. Patient Inspired.

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Our Independent physicians keep hometown healthcare where it belongs.

Jeffrey L. Tucker, CEO jtucker@ihnhealth.com 218.722.8802.112 Melissa Larson, Vice President, Operations mlarson@ihnhealth.com 218.722.8802.115 IntegrityHealthNetwork.com Delivering a network of solutions

888.722.8802 MARCH 2016 MINNESOTA PHYSICIAN

INTERVIEW

A new ecosystem for health Please tell us what innovation means in health care. Innovation is discovering and implementing solutions 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.

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 Governor’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 Distinguished Service Award from the MMA.

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 narrow 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, transportation, 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 integrating 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

MINNESOTA PHYSICIAN MARCH 2016

need, followed by a way to bring about accessible and affordable services within a system that is capable of rapid, adaptive change. In my view, this new ecosystem for health will be initiated and implemented by individuals and organizations outside of established medical 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 institutions—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 providers, challenge assumptions, take risks, and make significant changes for the future of health. These isolated, independent actions that focus on improving 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 frustration 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. Transform is a catalyst for engaging people to boldly create a sustainable future for health. In 2015, more than 700 attendees from 34 states and 15 countries with backgrounds as providers, administrators, researchers, 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

diabetes. As Evan got older, Costik became more anxious about the constant monitoring 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 What can physicians do to help create are at school, at daycare, at a sleepover, or the new ecosystem for health? while playing sports. Now nearly two years Physicians have to begin by thinking about later, this system serves the needs of 14,000 health ﬁrst, and then what it means to truly people. From an anxious dad’s need, a small understand people’s health needs. From grassroots revolution was born. 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 A multi-billion dollar clinical measures or processes. 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 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 physicians with prescriptions and proscriptions that are not relevant to a person’s goals for health. Here are three examples of individuals who have made change possible: At the 2015 Transform gathering, software developer John Costik talked about his son Evan, who was born with type 1

measurement industry … has lost sight of the need to improve health.

of members in the last open enrollment period in New York, one of the most competitive 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 created 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-todoor 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 naturally gravitating toward resources and At that same event, entrepreneur Mario connections that work for them. EntrepreSchlosser discussed how he started an alternative insurance company called Oscar. neurs are already innovating in response to Silicon Valley investors who wanted to make what truly benefits people. I hope we can see more changes like these within our health long-term revolutionary changes in health care system within the next two years. It will care funded this startup. Paying its first take longer for full realization however. benefits in 2014, Oscar now claims 40,000 members, more than doubling the number

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MARCH 2016 MINNESOTA PHYSICIAN

Making an ACO work from cover

Savings Program (MSSP) ACO. This program is a key component of the Medicare reform initiatives included in the Affordable 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 improve the quality of care for Medicare beneﬁciaries and reduce unnecessary costs. By participating in the MSSP, we provide better care for individuals, improve 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

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

Healthy patients are more likely to not see their provider on a yearly basis.

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 assisting physician-led ACOs. To clear the path to ACO success, we are increasing the presence of Integrity staff

MINNESOTA PHYSICIAN MARCH 2016

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 having timely, actionable data to present to our clinics, and more speciﬁcally, to the individual 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 Services (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 available 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, providers also engage the resources 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 understanding so they can improve the

care they give as well as the cost efficiency of that care. Lessons in quality CMS has structured the ACO process with the intent to create a balance between reducing costs without sacrificing the quality of care delivered. Through the group practice reporting option (GPRO), ACOs are required to submit data from which a quality score is calculated. That score is then applied to the final calculation for any shared savings that may be due the ACO. The higher the quality score the greater the percentage 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 preventive 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 Systems (CAHPS) survey administered each year. This survey measures the patients’ experience in their primary care clinic. Because this is based solely on a patient’s perception it is important not only to perform 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

as a secondary gain to providing higher quality care in the primary care setting. This also results in fewer emergency department visits, fewer unnecessary admissions, and lower specialty care costs.

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

Lessons in engagement Patient engagement has become one of the “buzz words” in health care over the past few years. Without increased patient involvement 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.

many of the quality improvement 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 connected to their provider.

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

We have already discussed the value of provider-speciﬁc data to get and keep providers 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 relatively high. It would appear that there was little improvement opportunity. At ﬁrst this was

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

actually a distraction; why work on getting better when we’re already so good! But when the providers saw information on their patients they immediately 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 themselves. There have been both

operational and clinical paradigm shifts. Clinically there has been a reinforcement of and shift toward a more patient-centered medical home (PCMH) model of care delivery. Regardless of certiﬁcation, the concepts of patient centricity and team care delivery have been found to be both fruitful and rewarding. Operationally, and to some degree clinically, there has been and continues to be a retooling of EHR use and IT infrastructure to improve the collection of key data elements and the data extraction and report generation abilities of EHRs. The challenges There are administrative burdens to operating an ACO, especially a smaller organization like IHN. It can be quite a challenge to operate in the Minnesota marketplace, where more than 50 percent of seniors have enrolled in Medicare Advantage Making an ACO work to page 41

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Minnesota Medicaid ACO initiative from cover

Minnesota became the ﬁrst state to implement an accountable 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 providers, 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 ﬁnancial standpoint and from the perspective of integrating better care for the people served by Medical Assistance and MinnesotaCare, Minnesota’s public health care programs. Pioneering programs employ emerging professions like community paramedics to visit high-risk patients in their homes, and

work with patients to coordinate 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.

room visits. Providers and taxpayers 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

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

In its ﬁrst two years, the IHP saved more than $76 million, with most of the savings occurring during the second year. These savings arose from transforming health care delivery, including providing more direct preventive care, more coordination, and fewer unnecessary hospitalizations and emergency

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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 started The IHP’s roots go back to 2010, when state legislators authorized the DHS to test innovative health-care delivery systems, including ACOs. That led to the development of the IHP, originally called the Health Care Delivery System (HCDS). The demonstration began in 2013 after the federal Centers for Medicare & Medicaid Services approved Minnesota’s new payment 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 procedures. 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. Participating providers are eligible to

MINNESOTA PHYSICIAN MARCH 2016

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-forservice care enrollees so providers can focus on their whole population. What IHP offers With funding through a $45 million State Innovation Model (SIM) grant from the Center for Medicare & Medicaid Innovation, 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 complex medical conditions. The IHP model gives each provider group the flexibility to design and develop their own approaches. Many participating providers have taken steps such as providing more intensive primary care services and working with mental health care providers and community resources to better coordinate care. For instance, Mayo Clinic’s Employee and Community Health expanded locations, set more convenient hours, and encouraged patients to manage their chronic illnesses. Overall, efforts like these have resulted 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 role Before joining the IHP in 2014, Hennepin County Medical Center (HCMC) was already a leader in developing the community health worker role as an emerging profession in Minnesota. 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

from multiple countries; the team can communicate with patients in four languages other than English. The team provides culturally specific and language-specific care coordination, 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

lot on their plate,” Aidoo-Abrahams 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, ethnicity, race, culture, class, and geography, as well as increasing community capacity for better health.”

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

services they need, or by helping coordinate care for patients with chronic conditions by explaining transportation, appointments, and prescriptions in a patient’s native language. Aidoo-Abrahams approaches 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 certificate 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

Osmo Vänskä /// Music Director

Conclusion By 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.

ASHER FISCH

SARAH HICKS AND SAM BERGMAN

MINNESOTA ORCHESTRA

CIRQUE DE LA SYMPHONIE

STRAUSS’ MERRY PRANKS Thu May 12 11am / Fri May 13 8pm Asher Fisch, conductor / Amber Wagner, soprano We hear the prelude to Parsifal, the capstone to Wagner’s career, the heavenly Liebestod from Tristan and Isolde with the wondrous young American soprano Amber Wagner, plus musical gems by Richard Strauss.

INSIDE THE CLASSICS: THE EVOLUTION OF OPERA Fri May 20 8pm Sarah Hicks, conductor / Sam Bergman, host and violist Join Sam and Sarah as they explore the history of opera: lifting the curtain on the dramatic combination of singers, players, stage and story. Conversation, fun facts and a complete performance.

Tickets $29 / $20 tickets for patrons under the age of 40

CIRQUE DE LA SYMPHONIE with the Minnesota Orchestra Sat May 21 8pm / Sun May 22 2pm Sarah Hicks, conductor :DWFK WKH 2UFKHVWUD SHUIRUP ZKLOH DOO DURXQG WKHP DQG Á\LQJ over their heads!) the internationally acclaimed artists—aerialists, acrobats, contortionists, jugglers and strongmen of Cirque de la Symphonie—bring the Big Top to Orchestra Hall.

minnesotaorchestra.org 612.371.5656 / Orchestra Hall PHOTOS Fisch: Chris Gonz; Hicks and Bergman: Josh Kohanek Photography; Orchestra: Tim Rummelhoff; Cirque: Courtesy of CDLS

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MARCH 2016 MINNESOTA PHYSICIAN

ELECTRONIC HEALTH RECORDS

n Jan. 1, 2016, legislation went into effect in the state of Minnesota that will change the prescription prior authorization (PA) processing landscape. The legislation mandates that drug prior authorization requests must be accessible and submitted by health care providers, and accepted by group purchases electronically through secure electronic transmissions. 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 legislation is unique in its strict requirement for 100 percent electronic prior authorization (ePA) submissions. To date,

The Electronic Prior Authorization Mandate What physicians need to know By Perry Lewis

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 efﬁciencies for the prescriber, health plan, pharmacy, and patient. Recognizing this, California initially legislated a universal paper form, and recently updated language to include

an electronic process following 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 solutions include real-time claim adjudication, eligibility and beneﬁt veriﬁcation, real-time ordering by the physician, and sharing of medication history.

administrative simpliﬁcation and to establish and implement uniform electronic transaction standards for health plans and providers. The Minnesota 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 submitting all PA requests electronically. Currently, some physician ofﬁces still use fax or phone to submit a PA request to the plan; however, this results in more

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

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 processing 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 clinicians and communities, and strengthen and improve public health in Minnesota. It also funded resources to support

MINNESOTA PHYSICIAN MARCH 2016

paperwork and waiting on hold, which ultimately delays treatment for the patient. By submitting all PA requests electronically, prescribers stand to gain back valuable time, save money, and eliminate frustration by skipping paper forms. In fact, based on survey data, physicians and their staff who use ePA solutions, 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 abandonment 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 pharmacy. Data from the Electronic Prior Authorization National Adoption Scorecard published by CoverMyMeds indicates that at least 71 percent of PA requests are initiated 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 electronically and make them available to prescribers online. Prescribers 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 nothing. Prescribers have several options discussed here. Electronic Health Record (EHR) System: Some prescribers 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 requires 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’ prescription needs. Additionally, it creates the ability to prospectively (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. Information on the availability of ePA in EHR systems can be found in

the Electronic Prior Authorization National Adoption Scorecard available at epascorecard. covermymeds.com.

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

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

In order to fully realize the beneﬁt of this legislation, more prescribers need access to ePA functionality in their EHR. This allows prescribers to access one system to manage all prescriptions and PA requirements 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 complete requests started by the pharmacy. Web portals for ePA are typically free for prescribers 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.

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 working 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 capabilities into their workﬂow.

Perry Lewis is vice president of

industry relations at CoverMyMeds, with a focus on pharmacy association engagement and leading advocacy 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 Prescription Drug Programs (NCPDP).

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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, payers can help make the process MARCH 2016 MINNESOTA PHYSICIAN

CARDIOLOGY

echnological advances have made the transradial artery method safe and effective for interventional cardiologists willing to jump back on the learning curve. At HealthEast, all interventionalists regularly use the radial artery as an access point for coronary angiography and other 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 ﬂuoroscopy to guide it up the arm and to the heart. While standard in much of Europe, the wrist-based technique using the radial artery is just starting to hit its stride in the United States. The femoral artery approach has been the mainstay in the United States, overtaking the brachial approach in the late 1970s and early 1980s. The radial approach for coronary angiography advanced in the late 1990s as an alternative to accessing

Radial access No longer radical By Carmelo J. Panetta, MD

the femoral artery through the groin, but, due to challenges with sheath design, usage waned until improvements were introduced eight to nine years ago. Previous sheaths could stick to vessel walls and case reports noted tearing of the radial artery intima during sheath removal. With more cardiologists and radiologists using the radial 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 reduced the incidence of artery spasm, a painful and sudden constriction. A learning curve The transradial method presents several challenges for interventionalists, but none that cannot be overcome with experience. It may take 50 to 100 procedures to achieve proﬁciency. In general, operators 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.

It may take 50 to 100 procedures to achieve proﬁciency.

Transradial access involves a small artery and a small needle, 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

MINNESOTA PHYSICIAN MARCH 2016

quickens procedures, and it can be used as a preoperative screening tool for vessels that are too small or calcified. The operator must pay particular attention to anticoagulation medicine and dosing. Care must be exercised when applying a band over the radial access site during sheath removal, as proper technique lowers the risk for bleeding and clotting of the radial artery. The benefits The transradial and transfemoral methods share several complications: bleeding, stroke, nerve damage, and surgery to repair the artery. The transradial method stands out by offering a significant reduction in time to ambulation. While patients undergoing catheterization 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 monitored 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 approach 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. Bleeding is easier to identify and control from the wrist than the groin, so the common complication 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.

Due to a secondary blood supply from the ulnar artery, the transradial technique carries less risk for limb damage than the brachial or femoral arteries. A criticism of the transradial method is that catheterization 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, compartment syndrome, requires special surgery, but this complication is extremely rare. For those who become proﬁcient in radial access, several studies 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 discouraged for patients on or near dialysis, as the radial artery is used for grafts and ﬁstula. Walker-dependent patients are not ideal candidates, as unnecessary pressure applied to the

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 method’s beneﬁts in the heart attack setting, for example, would not be within reach until an interventionalist is sufﬁciently comfortable with the technique.

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

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.

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 complications and are adept at quickly responding, creating a safe environment across the board for the approach. With the radial artery proving to be a reliable access site, the advantages of transradial access related to patient outcomes and convenience should make it not merely a useful alternative for certain patient populations but the standard method for coronary angiography and interventions. Carmelo J. Panetta, MD, of

HealthEast Heart Care, is boardcertiﬁed 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.

MARCH 2016 MINNESOTA PHYSICIAN

SPECIAL FOCUS: OUTCOME-DRIVEN REIMBURSEMENT

aximizing 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. Beginning in 2015, the Centers for Medicare & Medicaid Services (CMS) has three quality incentive programs—Medicare Electronic 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 services, 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

Maximizing Medicare payments A look at incentive programs By Candy Hanson, BSN, PHN 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 assistants, nurse practitioners, clinical nurse specialists, nurse anesthetists, and others depending 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 composite 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 organizations 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 performance on quality and cost measures in calendar 2013.

reporting is based on data two years prior (i.e., payment adjustments for 2016 are based on calendar year 2014), providers 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 participating fully in these programs now is one of the most important

Table 1. Timeline for evolving CMS quality incentive programs Age 76 Squamous Cell Carcinoma

Age 25 Melanoma

Age 55 Basal Cell Carcinoma

Timeframe

Medicare Quality Incentive Programs

Ending Dec. 31, 2018

Electronic Health Record (EHR) Incentive Through 2016 Physician Quality Reporting System (PQRS) Value-Based Modiﬁer (VBM)

Starting Merit-Based Incentive Payment System Jan.1, 2019 (MIPS)

Data Collection Period

Starting 2017

Source: Stratis Health

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Do PQRS measures apply to me? One Minnesota specialty clinic estimates that in 2016 they will lose Medicare payments equivalent to its ofﬁce manager’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, especially 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

steps physicians, other eligible professionals, and their organizations 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 opportunity to earn bonus payments for having better than average composite 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 to page 36

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SPECIAL FOCUS: OUTCOME-DRIVEN REIMBURSEMENT

y son, Siah, broke his finger playing football 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 orthopedic 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 questioning 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 simply readjusted the splint, and said that unless Siah experienced more pain or problems, he didn’t have to come back. My wife and I estimated that we

Health literacy Creating a better-informed patient By Mick Hawton

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.

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

Educated patients are healthier.

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.

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 beneﬁt, from increased efﬁciency to improved patient/provider interactions. Ultimately, this positively impacts all involved, from families like mine to doctors and clinic staff. What is health literacy?

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According to the National Center for Education Statistics, health literacy can be deﬁned as, “the degree to which individuals have the capacity to obtain, process, and understand 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 information 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 organizations they can go to for care. They could go to online clinics, walk-in clinics at popular

retailers, primary care clinics, urgent care facilities, or emergency rooms. And once patients get to the right place, there is much more beyond that to understand, from how their insurance 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 treatment 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, emotional, 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 literate, 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 transactional to collaborative. Health literacy is also important to doctors because educated patients are healthier. 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 helping patients understand how to interact with the health care system so they can improve outcomes. 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

literate, there are some key ways that physicians and clinics can help. Determining how health literate a patient is From a statistical standpoint this is not too difﬁcult, as the studies conducted by the organizations mentioned earlier in this article show that only 12 percent of people 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 information. 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 treatment plan. The ﬁrst is how many questions 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 outcomes 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 follow treatment plans. For those who are not health literate, however, they need to be encouraged 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.

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

caregivers, outcomes are more important than ever. Improving 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 difference for everyone involved.

Only 12 percent of people are health literate.

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

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

Conclusion In today’s health care environment, for both patients and

• 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 information. 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 patients are making the most of this tool. Proper documentation 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

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MARCH 2016 MINNESOTA PHYSICIAN

PROFESSIONAL UPDATE: MEDICAL ETHICS

n the movies and on television, 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 proceeding 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 conversations. I will discuss breaking bad news to patients and families, with an emphasis on social and ethical considerations. Discussing bad news The concept of patients being made aware of bad news is, somewhat surprisingly, a relatively novel concept. Just a few decades ago, medical professionals willingly and knowingly

Breaking bad news A challenge we all face By Kathleen Kieran, MD, MS withheld unfavorable information 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 physicians 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 education 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 Partnership). Although the proportion of physicians informing patients of an undesirable diagnosis has increased, the scope of information 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 terminally ill patients. Contemporary literature on this topic reﬂects near-universal agreement that patients should be made aware of their diagnoses and health status unless there is a compelling reason not to do so, and emphasizes optimizing the delivery of this information in a personally

sensitive and culturally competent manner (Surbone, Lancet Oncology, 2006). It’s important to note that this may not actually 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 difﬁcult conversations, and must be alert for patient, clinician, and external factors that may impact this interaction. Potential barriers to breaking bad news Both 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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MINNESOTA PHYSICIAN MARCH 2016

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 â&#x20AC;&#x153;MUM effect,â&#x20AC;? postulating that this reďŹ&#x201A;ected a dislike of giving bad news and/or an enthusiasm to give good news. While some clinicians may ďŹ nd it reassuring that their hesitance to deliver bad news is scientiďŹ cally validated, it must be pointed out that Tesser and Conleeâ&#x20AC;&#x2122;s study was based on third-party, word-of-mouth assessments regarding the emotional state of the recipient. In other words, patientsâ&#x20AC;&#x2122; emotional states were determined by the assessment of others, rather than by asking the patients. This reality has signiďŹ cant implications for the physician/ patient relationship: the (sometimes erroneous) assumption that particular behaviors or expressions portend speciďŹ c emotions may lead clinicians to (sometimes erroneously) predict a given patientâ&#x20AC;&#x2122;s response to bad news. Phrased this way, it

is easy to see how an apparent desire to protect the patient actually reďŹ&#x201A;ects an underlying respect for patient individuality and autonomy. Equally important in the physician/patient interaction are the concepts of transference and countertransference, where one party takes on the emotions that he or she perceives are being expressed by the other party. In many cases, physicians may also be able to identify their own emotions or behaviors that affect their ability to give bad news (e.g., a

to set the stage for a meaningful discussion. While personal awareness training can help physicians to become more aware of their own emotions and behavior (Smith, Dwamena, & Fortin, 2005), such training is not yet universal in medical school and graduate medical education, despite published data suggesting that learners would beneďŹ t from emotional support from peers as well as repeated skills practice (Dosanjh, Barnes, & Bhandari, 2001).

Neither physicians nor patients enjoy a discussion about bad news. patient reminding a physician of his or her grandmother). Achieving and maintaining awareness of oneâ&#x20AC;&#x2122;s own emotions, and checking in with the patient about his or her emotional status prior to delving into a discussion of bad news, is crucial groundwork needed

How to break bad news There is no simple â&#x20AC;&#x153;recipeâ&#x20AC;? for breaking bad news. Ideally, bad news should be delivered in a â&#x20AC;&#x153;safeâ&#x20AC;? physical and emotional environment for the patient; that is, a respectful space free of distractions. Many physicians ďŹ nd 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 patientâ&#x20AC;&#x2122;s physical comfort by ďŹ nding 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 provide limited information to the patient and ask the patient to return in several hours or days (and often to bring a companion) to continue the discussion when physical and emotional conditions are more favorable. Although setting an agenda is useful in many patient/physician 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 Breaking bad news to page 38

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HEALTH DISPARITIES

ast African culture has its own way of conceptualizing, expressing, and treating mental illness. African concepts are rooted in religions that came to Africa centuries ago from both Europe and the Middle East and from the African indigenous traditions that were practiced long before outside inﬂuences. Even though both Christianity and Islam discouraged indigenous cultural practices, many communities ﬁgured out ways to incorporate them.

Somali perceptions of mental illness Somalis express mental illnesses 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.

East African culture and mental health Blending two worlds By Ahmed M. Hassan, MA, LPCC

Waali translates as “crazy” or “mad.” Symptoms of waali include violent behavior, taking 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 capable of exerting inﬂuence over human action and behavior (Carroll, 2004). The symptoms include appearing “unconscious,” spirit possession (disassociation), being mentally unﬁt, being afraid, and going mad. Other common beliefs include zar, the dominance of the

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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 relatives; otherwise, the evil spirit will cause trouble for that person. Other disorders are caused by sihir, a fetish or charm devised by one person to intentionally 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 predate 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 powers introduced Western medicine, 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 practitioners, and such. Traditional African healers 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 transcendence 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 struggle 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 community who participate in the healing rituals. If the patient cannot be rid of the condition and develops a long-term impairment, the family is expected to counterbalance the ill effects by caring for the person. Cultural considerations when treating the Somali population Pre-immigration stressors During the Somali civil war, citizens lived in a fightor-flight mode. Often Somali men experienced torture, and Somali women experienced both torture and rape intended to terrorize them into submission. Many surviving Somalis, 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 camps Many Westerners misunderstand 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 hostile local populations outside.

In addition to the traumatic experiences are deprivations such as poor housing and shortage of water and food. Lack of employment in the camps causes refugees to develop a sense of loss, low self-esteem, and helplessness. 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 activities that require legal documents. 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, disassociation, 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 struggle 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 generations cannot be overstated.

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 scientiďŹ c process are to Western society. 2. There is a widespread fear of being detained and hospitalized if one is diagnosed with mental illness. This fear comes from Somalisâ&#x20AC;&#x2122; experience of â&#x20AC;&#x153;Westernizedâ&#x20AC;?

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

Barriers to seeking help A 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

Family Medicine

treatment in Africa, where hospitalized patients are sometimes chained and drugged with no hope of recovery. There is a misunderstanding among Somalis about psychotropic medication, 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 horriďŹ c situations in the war and the camps, the discomfort of anxiety and depression seem relatively manageable. There is a mismatch between Somali and Western ideas about what deďŹ nes mental illness and what is considered severe. The range of â&#x20AC;&#x153;normalâ&#x20AC;? behavior in Africa 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 strategies for healing themselves, but Somalis view a more passive role for themselves, East African culture and mental health to page 40

Itâ&#x20AC;&#x2122;s your life. Live it well.

Minnesota and Wisconsin We are actively recruiting exceptional board-certiďŹ ed family medicine physicians to join our primary care teams in the Twin Cities (Minneapolis-St Paul) and Central Minnesota/Sartell, as well as western Wisconsin: Amery, Osceola and New Richmond. All of these positions are full-time working a 4 or 4.5 day, Monday â&#x20AC;&#x201C; Friday clinic schedule. Our Minnesota opportunities are family medicine, no OB, outpatient and based in a large metropolitan area and surrounding suburbs. Our Wisconsin opportunities offer with or without obstetrics options, and include hospital call and rounding responsibilities. These positions are based in beautiful growing rural communities offering you a more traditional practice, and all are within an hoursâ&#x20AC;&#x2122; drive of the Twin Cities and a major airport. HealthPartners continues to receive nationally recognized clinical performance and quality awards. We offer a competitive salary and beneďŹ ts package, paid malpractice and a commitment to providing exceptional patient-centered care. Apply online at healthpartners.com/careers or contact diane.m.collins@healthpartners.com, 952-883-5453, toll-free: 800-472-4695. EOE

Family Medicine with or without OB 2XU LQGHSHQGHQW SK\VLFLDQ RZQHG FOLQLF LV VHHNLQJ D %& %( SK\VLFLDQ ZLWK RU ZLWKRXW 2% IRU RXU FOLQLF &DOOV &RPSHWLWLYH VDODU\ EHQHĂ&#x20AC;WV ZLWK RSSRUWXQLW\ IRU RZQHUVKLS ZLWKLQ \HDU 3DLG PDOSUDFWLFH KHDOWK DQG GHQWDO LQVXUDQFH N &0( DQG PRUH Cloquet is an historic, vibrant community just 15 minutes from Duluth and 10 minutes from Jay Cooke State Park. Adjacent to the St. Louis River, Cloquet KDV KLNLQJ ELNLQJ DQG $79 WUDLOV VNLLQJ ERDWLQJ Ă&#x20AC;VKLQJ SDUNV DQG WKH RQO\ ZKLWH ZDWHU UDIWLQJ LQ 0LQQHVRWD 5HVLGHQWV HQMR\ ORFDOO\ SHUIRUPHG SOD\V FRQFHUWV DQG WKH DUWV FRPPXQLW\ IHVWLYDOV GLQLQJ DQG PRUH

Send CV to: cward@raiterclinic.com H[W Â&#x2021; ZZZ UDLWHUFOLQLF FRP 6N\OLQH %OYG Â&#x2021; &ORTXHW 01

healthpartners.com MARCH 2016 MINNESOTA PHYSICIAN

MEDICINE AND THE LAW

hysicians are wellpositioned 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 strategy So, 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 idea Confidentiality is key. Don’t tell anyone about your idea because disclosure can create significant problems. If you were to disclose your invention to a third party without a confidentiality agreement in place, you would technically have one year in which to file a

Intellectual property in medicine A guide to an effective patent strategy By Sean Solberg, JD 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 development. What constitutes disclosure? Don’t take any chances— do not disclose your invention to anyone without first consulting a patent attorney. There are situations, such as talking to a potential business partner, in which it may be necessary to disclose your invention to a third party before you file your patent application. If you haven’t filed your patent application and you must disclose

Employment Opportunity Clinic Administrator Orthopaedic Associates of Duluth, P.A. is a physician-owned, highly reputable, well established clinic with ten physicians, eight physician assistants, and nine physical and occupational therapists. We are seeking an experienced Clinic Administrator to provide strategic and operational leadership for the medical practice within our three northern MN locations. The position is responsible for overall financial and operational management of the daily activities including operations, accounting, medical and business information systems, marketing/public relations, personnel administration, and planning and development. The selected candidate will have superior management, interpersonal, and analytical skills and be a strong communicator. Must have a solid financial background and be comfortable in a clinic environment. The position continually monitors operations as well as corporate compliance, HIPAA, risk management, and patient satisfaction. Represents the clinic in its relationships with other healthcare organizations, government agencies, and third party payers. The Administrator is accountable to the physicians. Bachelors degree with 7-10+ years of experience in physician practice management required. Position offers a competitive salary and excellent benefits package. Email resume to marisa.haggy@slhduluth.com or fax to attn: Marisa 218-722-6515.

MINNESOTA PHYSICIAN MARCH 2016

the invention, an appropriate confidentiality agreement drawn up by your patent attorney can preserve your rights to pursue a patent application. Regardless, the best approach is to file your patent application before you disclose your invention, which eliminates the risk of public disclosure. 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 filing and until the application publishes. A confidentiality agreement at this point can also protect against public disclosure of any additional inventions or improvements you may have developed since you filed the application. Hiring an attorney It is important to find a good patent attorney. Developing an effective patent strategy is complex and not for the inexperienced. 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 ownership, the answer depends entirely on whether you are an employee or independent contractor based on your contract with your hospital or medical clinic. Many physicians are contractors and own any inventions they create. Of course, ownership depends on the specific language in the contract. If you are a contractor and your contract does not include an

obligation to assign your invention 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 property rights to your employer. Regardless, the key is to have your patent attorney examine your contract to determine your rights and obligations. Prior art Before you go any further, you also need to consider whether your invention is actually patentable. Your patent attorney can perform a patentability search prior to filing your application. The attorney—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 (referred to as “prior art”) similar to yours. The attorney will then analyze those search results to determine whether your invention 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. Alternatively, you can get a sense of the prior art in your area of technology by doing a very rough

prior art search yourself on the Patent Office website—the database can be found at http:// patft.uspto.gov/. Freedom to commercialize your technology Now that you have a better understanding of patent strategies, it’s time to consider commercialization. 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 “freedom 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’ patents can seem counterintuitive to first-time inventors. This confusion originates from a fundamental misunderstanding 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 strategy You 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 strategy 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 invention. 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.

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 technology, 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 develop your technology, another

A patent does not protect against potential infringement. Funding concerns Regardless of your specific strategy, you will need funding to get things off the ground. Will you fund the venture yourself, 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 investors depends on an IP strategy 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 complicated by the fact that some investors refuse to sign confidentiality 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 company If 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 provisional patent application here in the United States. A provisional application is a low-cost mechanism for getting an effective filing date for your patent application that has a non-extendable 12-month pendency period and fewer requirements than a standard non-provisional patent

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 provisional 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 technology Alternatively, 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 prosecution 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 patent as quickly as possible may Intellectual property in medicine to page 34

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

Contact: Todd Bymark, tbymark@cuyunamed.org (218) 546-3023 | www.cuyunamed.org MARCH 2016 MINNESOTA PHYSICIAN

Intellectual property in medicine from page 33

very well outweigh the additional upfront costs associated with the non-provisional (vs. the provisional). Your business plans will also influence the depth of any freedom-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 freedom 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 basics Now that your patent strategy is in place, you can turn your attention to filing a patent application. As discussed earlier, you can file either a provisional (and then a non-provisional within a year) or a non-provisional application in the U.S. Regardless of the approach, you will ultimately need to file the non-provisional in order to pursue a patent.

Don’t tell anyone about your idea because disclosure can create significant problems. Once you have filed your application, what happens next? Many first-time inventors 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. Drafting and filing the application

North Memorial is hiring MDs, NPs and PA-Cs.

He needs you.

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 invention 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-

We are a fiercely independent, physician-led organization. Our physician leaders, including our CEO, and VPs see patients every week. Healing defines us. Not bureaucracy. We treat our patients and our employees better. We’re committed to ensuring our providers have fulfilling clinical work, competitive salary and benefits, and work-life balance. Interested applicants may contact: Robert McDonald, MD Medical Director, Primary Care Robert.McDonald@NorthMemorial.com Todd Gengerke, MD Medical Director, Urgent Care and Convenient Care Medicine Todd.Gengerke@NorthMemorial.com

MINNESOTA PHYSICIAN MARCH 2016

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 requirements for the claims. Upon receipt of the office action, you will want to consult 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 explanation 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 unusual to have multiple rounds of office actions and responses for any given patent application. As of December 2015, the average 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 protection Of 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 protection. 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 patent strategy outside the United States. If you are planning to pursue foreign patent protection in two or more foreign countries, the simplest, most cost-effective approach is a PCT application, which is an international patent application created 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 application). Subsequently you have 30 months from the original filing to enter any foreign jurisdictions that are party to the treaty with the same patent application and preserve the original filing date thereof. Conclusion The road from invention to an issued patent is not easy or simple—it is a complex process that requires determination, 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 focuses mainly on medical device and biotech technologies and works with several physicians and other clients in Minnesota.

rehabilitate a body, we start T owith the mind and soul. If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.

To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota.

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MARCH 2016 MINNESOTA PHYSICIAN

Maximizing Medicare payments from page 24

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 Medicare beneficiaries attributed to them. Beneficiaries are attributed to a provider by having received the “plurality” of their services from a particular provider. Providers in specialty clinics have been surprised to learn that they have beneficiaries attributed to them. One optometry clinic found its cost composite score was impacted by its patients’ hospital stays. Understanding valuebased 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.

through Medicare’s 14 Quality Your clinic needs to underInnovation Network-Quality stand more than the data from Improvement Organizations the QRUR and other quality (QIN-QIO). The QIN-QIOs bring reports. Educate yourself and together providers at the local all members of your organilevel for collaborative learning zation about value-based care about value-based care. delivery. Everyone involved in patient care needs Tracking and to have at least a reporting data basic understandChallenge Effective quality ing about how CMS when its improvement can’t they impact value. be done without This environment findings don’t data. Decide what is ever-evolving seem right. data you can and and it’s become will collect to increasingly meet the reporting difficult for one requirements and help improve person in an organization to understand and oversee partici- care delivery for those measures that apply to you. Decide pation in all of the CMS incenhow often to pull data so it’s tive programs. Stay on top of meaningful and actionable. changes by having a multi-disThese decisions may evolve as ciplinary quality team. Orgayou experiment with how to nizations that flourish take the use your data, but you should time to bring everyone together review data more than annually. to help them understand how In organizations that report care management is changing. via claims, a multi-disciplinary If you are a solo practice, conteam that includes billing sider networking with others. and coding staff will help you Education and networking reach success. Organizations opportunities are available 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.

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

Cardiology Dermatology Emergency Medicine Family Medicine

OB/GYN Orthopedics (Adult & Pediatric)

EOE/M/F/Vet/Disabled

PLEASE CONTACT

800-882-7310 | www.essentiahealth.org/careers

MINNESOTA PHYSICIAN MARCH 2016

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 opportunity to discover inconsistencies and improve workflows. As EHRs are harnessed to more effectively produce meaningful data, more details will be available 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 practitioners received negative payment adjustment notifications 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 negative payment adjustments. In 2014, some eligible professionals 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 payment adjustment. Success by aligning with value Your team members might feel like Sisyphus, starting over each time the incentive programs evolve. As your practice makes changes to stay vital during this time of healthcare 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, ValueBased 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.

BEYOND TREATING, THERE’S CARING W E L L A N D B E YO N D

DULUTH CAMPUS

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

We currently have opportunities in the following areas: t t t t t t t t t

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

t t t t t t t t t

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

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

Sorry, no J1 opportunities.

Assistant Professor The University of Minnesota Medical School Duluth invites applications for a full-time Assistant Professor (teaching track; non-tenured) in the Department of Family Medicine and Community Health Duluth. Candidates must have a M.D. or D.O. degree with Board Certiﬁcation in Family Medicine or other primary care specialty, licensed or license eligible in Minnesota, with a minimum of 3 years of related clinical practice. Evidence of essential verbal and written communication skills, including clarity in the delivery of lectures, as well as evidence of medical student and/or resident teaching is required. Preference will be given to candidates in the Family Medicine Specialty with experience with collaborative relationships including work in team settings with other health care professionals. Experience with teaching in a variety of settings and formats, including lectures, small groups and clinical instruction and interest in or evidence of medical education research is preferred. Experience in curriculum development, innovative teaching and learning practices and grant writing is strongly desired. For additional details regarding the position and to ensure consideration follow the application instructions online at: http://www1.umn.edu/ ohr/employment/index/html (Job Opening ID #307392) Questions concerning the online application process should be directed to Linda Liskiewicz at lliskiew@d.umn.edu. The University of Minnesota is an equal opportunity educator and employer.

Join the top ranked clinic in the Twin Cities

Sioux Falls VA Health Care System

A leading national consumer magazine recently recognized our clinic for providing the best care in the Twin Cities based on quality and cost. We are currently seeking new physician associates in the areas of:

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

• Family Practice • Urgent Care We are independent physicianowned and operated primary clinic with three locations in the NW Minneapolis suburbs. Working here you will be part of an award winning team with partnership opportunities in just 2 years. We offer competitive salary and benefits. Please call to learn how you can contribute to our innovative new approaches to improving health care delivery.

Please contact or fax CV to:

Joel Sagedahl, M.D. 5700 Bottineau Blvd., Crystal, MN 55429

763-504-6600 Fax 763-504-6622

Cardiologist

Orthopedic Surgeon

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Primary Care (Family Practice or Internal Medicine)

ENT (part-time) Emergency Medicine Gastroenterologist Hospitalist Oncologist

Psychiatrist Pulmonologist Urologist (part-time)

(605) 333-6852 www.siouxfalls.va.gov Apply online at www.USAJOBS.gov www.NWFPC.com MARCH 2016 MINNESOTA PHYSICIAN

Breaking bad news from page 29

perception that the physician is â&#x20AC;&#x153;dumpingâ&#x20AC;? bad news on the patient by stating facts and immediately departing. When calculating the expected duration of the visit, physicians should recognize that patients receiving bad news would likely need time to process the information they are receiving. Over time, every physician will ďŹ nd the â&#x20AC;&#x153;bestâ&#x20AC;? 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 physician/patient interaction and the involvement of family members 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 ďŹ nd 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 patientâ&#x20AC;&#x2122;s Perception 3. Obtaining the patientâ&#x20AC;&#x2122;s Invitation to proceed further with the discussion 4. Giving Knowledge and information to the patient 5. Addressing the patientâ&#x20AC;&#x2122;s Emotions with Empathic responses 6. Strategy and Summary Although not every bad news encounter will require that all the steps be followed, this useful framework helps clinicians organize what is often a stressful encounter for both provider and patient. Honesty is best Physicians are ethically and legally mandated to share information with patients about

health care that would change patient outcomes. Published data suggest that the overwhelming majority of patients wish to be included in these discussions. 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 physician believes that these goals are clinically reasonable and achievable, then the physician and patient must discuss the relative and absolute risks and beneďŹ ts of limiting the delivery of bad news. Shared decision-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. Conclusion In 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 Childrenâ&#x20AC;&#x2122;s Hospital. She has a special interest in communication skill teaching and development in surgical subspecialty trainees.

Olmsted Medical Center, a 220-clinician multi-specialty clinic with 10 outlying in ng branch clinics and d a 61 bed hospital, continu nu ue ues [V L_WLYPLUJL ZPNUPĂ&#x201E;JHU[ NYV^[O 6STZ[LK 4LKPJHS *LU[LY WYV]PKLZ HU L_JLSSLU[ VWWVY[\UP[` [V WYHJ[PJL X\HSP[` TLKPJPU L__JLSSLU[ [ VW V WVY[\UP[` [[V VW [V ULL PU H MHTPS` VYPLU[LK H[TVZWOLYL ;OL 9VJOLZ[LY JVTT\UP[` WYV]PKLZ U\TLYV\Z J\S[\YHS LK\JH[PVUHS HUK YLJYLH[PVUHS U\TLYV V\Z J\S \ [\YHS S LK HS HS VWWVY[\UP[PLZ 6STZ[LK 4LKPJHS *LU[LY VMMLYZ H JVTWL[P[P]L ZHSHY` HUK JVTWYLOLUZP]L ILULĂ&#x201E;[ WHJRHNL K JJVTWYLLOLUZP L I IL

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www.olmstedmedicalcenter.org 38

MINNESOTA PHYSICIAN MARCH 2016

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US Citizenship required or candidates must have proper authorization to work in the U.S. Physician applicants should be BE/BE. Education Debt Reduction Program funding may be authorized for the health professional education that was required of the position. Possible recruitment bonus. EEO Employer. &RPSHWLWLYH VDODU\ DQG EHQHÂżWV ZLWK UHFUXLWPHQW UHORFDWLRQ LQFHQWLYH DQG SHUIRUPDQFH SD\ SRVVLEOH

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(320) 255-6301 MARCH 2016 MINNESOTA PHYSICIAN

East African culture and mental health from page 31

believing that someone will heal them by expelling the force affecting them. Somalis 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 depression or anxiety to a psychosocial stressor such as a lack of housing or employment, which may seem more imperative to them than the deterioration 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 thinking, behaviors, and emotions. Clinicians should explore the resources their clients bring to the session and incorporate some of them in the treatment.

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

It is important to help Somali clients understand what is at stake if mental illness is ignored. For example, instead of introducing a relaxation technique the client is not familiar with, the clinician can explore relaxation techniques used in the client’s culture. Relating therapeutic interventions to concepts and practices familiar to the client 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

to help them understand the importance of practicing them. For example, explaining the connection between early childhood trauma and current symptoms encourages clients to talk about their past experiences. It is important to help Somali 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 fully 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 expected, among other things, to learn a new language, negotiate an unfamiliar bureaucracy, and compete with native-born citizens. Understanding the beliefs and practices of the country of origin, recognizing and addressing 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.

PHYSICIANS/ FAMILY L NURSE PRACTITIONERS/ PHYSICIAN ASSISTA T NTS:

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

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What if wo w rk w s where wa r yyou w nt to we t re r charg r e? Do you know what it feels like to work with a sense of purpose? At Marathon Health, we’re on a mission to put “health” back in healthcare. We have partnered with Cargill’s turkey and cooked meats business in Albert Lea, MN and are looking for a part-time (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.

F O R M O R E I N F O R M AT I O N :

Kari Lenz, Physician Recruitment | karib@acmc.com | (320) 231-6366 www.acmc.com |

MINNESOTA PHYSICIAN MARCH 2016

MARATHON HEALTH IS AN EQUAL OPPORTUNITY EMPLOYER

Making an ACO work from page 17

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 signiﬁcantly 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, represent 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 unnecessary admissions, readmissions,

and emergency department visits. This is, however, compelling good dialogue between hospitals and ACOs, particularly in rural areas.

has been to ﬁnd a platform for training clinic staffs, and documenting and tracking coordination activities, while ensuring a consistency of efforts across our network.

There are administrative burdens to operating an ACO.

Technology We’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

IT-related solutions are being employed in almost all ACO settings—from web-based education to text or email reminders to apps and programs that raise patient engagement. Data analytics is crucial and at various 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.

A Diverse and Vitall Health Service Welcome to Boynton Health Service

Conclusion The ACO concept is helping redesign the model of health care delivery across the country. 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 reinforce a basic tenet we have held since our inception. High-quality care does not have to be high-cost care; more accurately high-quality care is usually less expensive. Our primary focus as an organization of independent providers continues to be providing quality care to our patients. Secondarily, we strive to do so at a reasonable cost and, as our data demonstrates, 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.

Boynton Health Service

Physician

>ŽĐĂƚĞĚ ŝŶ ƚŚĞ ŚĞĂƌƚ ŽĨ ƚŚĞ dǁŝŶ ŝƟĞƐ ĂƐƚ ĂŶŬ ĐĂŵƉƵƐ͕ ŽǇŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ŝƐ Ă ǀŝƚĂů ƉĂƌƚ ŽĨ ƚŚĞ hŶŝǀĞƌƐŝƚǇ ŽĨ DŝŶŶĞƐŽƚĂ ĐŽŵŵƵŶŝƚǇ͕ ƉƌŽǀŝĚŝŶŐ ĂŵďƵůĂƚŽƌǇ ĐĂƌĞ͕ ŚĞĂůƚŚ ĞĚƵĐĂƟŽŶ͕ ĂŶĚ ƉƵďůŝĐ ŚĞĂůƚŚ ƐĞƌǀŝĐĞƐ ƚŽ ƚŚĞ hŶŝǀĞƌƐŝƚǇ ĨŽƌ ŶĞĂƌůǇ ϭϬϬ ǇĞĂƌƐ͘ /ƚ͛Ɛ ŽƵƌ ŵŝƐƐŝŽŶ ƚŽ ĐƌĞĂƚĞ Ă ŚĞĂůƚŚǇ ĐŽŵŵƵŶŝƚǇ ďǇ ǁŽƌŬŝŶŐ ǁŝƚŚ ƐƚƵĚĞŶƚƐ͕ ƐƚĂī͕ ĂŶĚ ĨĂĐƵůƚǇ ƚŽ ĂĐŚŝĞǀĞ ƉŚǇƐŝĐĂů͕ ĞŵŽƟŽŶĂů͕ ĂŶĚ ƐŽĐŝĂů ǁĞůůͲďĞŝŶŐ͘

ŽǇŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ŚĂƐ ĂŶ ŝŵŵĞĚŝĂƚĞ ŽƉĞŶŝŶŐ ĨŽƌ Ă ĨƵůůͲƟŵĞ ƉŚǇƐŝĐŝĂŶ ƚŽ ƉƌŽǀŝĚĞ ƐĞƌǀŝĐĞƐ ŝŶ ƚŚĞ WƌŝŵĂƌǇ ĂƌĞ ĂŶĚ hƌŐĞŶƚ ĂƌĞ ůŝŶŝĐƐ͘ ĂŶĚŝĚĂƚĞƐ ƐŚŽƵůĚ ĞŶũŽǇ ǁŽƌŬŝŶŐ ŝŶ Ă ĐŽůůĞŐĞ ŚĞĂůƚŚ ĞŶǀŝƌŽŶŵĞŶƚ ǁŝƚŚ Ă ůĂƌŐĞ ĂŶĚ ĚŝǀĞƌƐĞ ƉŽƉƵůĂƟŽŶ ŽĨ ƐƚƵĚĞŶƚƐ ĂŶĚ ƐƚĂī͘

ŽǇŶƚŽŶ͛Ɛ ŽƵƚƐƚĂŶĚŝŶŐ ƐƚĂī ŽĨ ϯϬϬ ŝŶĐůƵĚĞƐ ďŽĂƌĚ ĐĞƌƟĮĞĚ ƉŚǇƐŝĐŝĂŶƐ͕ ŶƵƌƐĞ ƉƌĂĐƟƟŽŶĞƌƐ͕ ƌĞŐŝƐƚĞƌĞĚ ŶƵƌƐĞƐ͕ D Ɛͬ>WEƐ͕ ƉŚǇƐŝĐŝĂŶ ĂƐƐŝƐƚĂŶƚƐ͕ ĚĞŶƟƐƚƐ͕ ĚĞŶƚĂů ŚǇŐŝĞŶŝƐƚƐ͕ ŽƉƚŽŵĞƚƌŝƐƚƐ͕ ƉŚǇƐŝĐĂů ĂŶĚ ŵĂƐƐĂŐĞ ƚŚĞƌĂƉŝƐƚƐ͕ ƌĞŐŝƐƚĞƌĞĚ ĚŝĞƟƟĂŶƐ͕ ƉŚĂƌŵĂĐŝƐƚƐ͕ ƉƐǇĐŚŝĂƚƌŝƐƚƐ͕ ƉƐǇĐŚŽůŽŐŝƐƚƐ͕ ĂŶĚ ƐŽĐŝĂů ǁŽƌŬĞƌƐ͘ KƵƌ ŵƵůƟĚŝƐĐŝƉůŝŶĂƌǇ ŚĞĂůƚŚ ƐĞƌǀŝĐĞ ŚĂƐ ďĞĞŶ ĐŽŶƟŶƵŽƵƐůǇ ĂĐĐƌĞĚŝƚĞĚ ďǇ , ƐŝŶĐĞ ϭϵϳϵ͕ ĂŶĚ ǁĂƐ ƚŚĞ ĮƌƐƚ ĐŽůůĞŐĞ ŚĞĂůƚŚ ƐĞƌǀŝĐĞ ƚŽ ŚĂǀĞ ĞĂƌŶĞĚ ƚŚŝƐ ĚŝƐƟŶĐƟŽŶ͘

dŚĞ ƋƵĂůŝĮĞĚ ĂƉƉůŝĐĂŶƚ ŵƵƐƚ ďĞ D^ ďŽĂƌĚ ĐĞƌƟĮĞĚͬĞůŝŐŝďůĞ ĂŶĚ ŚĂǀĞ ƚƌĂŝŶŝŶŐ ĂŶĚͬŽƌ ĞǆƉĞƌŝĞŶĐĞ ŝŶ ĂŶ ŽƵƚƉĂƟĞŶƚ ƉƌĂĐƟĐĞ ĂŶĚ ƵƌŐĞŶƚ ĐĂƌĞ͘ <ŶŽǁůĞĚŐĞ ŽĨ ĞůĞĐƚƌŽŶŝĐ ŚĞĂůƚŚ ƌĞĐŽƌĚƐ ǁŽƵůĚ ďĞ ďĞŶĞĮĐŝĂů͘ dŚŝƐ ƉŽƐŝƟŽŶ ŽīĞƌƐ Ă ĐŽŵƉĞƟƟǀĞ ƐĂůĂƌǇ͕ D ŽƉƉŽƌƚƵŶŝƟĞƐ͕ ĂŶĚ Ă ŐĞŶĞƌŽƵƐ ĂĐĂĚĞŵŝĐ ƐƚĂƚƵƐ ƌĞƟƌĞŵĞŶƚ ƉůĂŶ͘ WƌŽĨĞƐƐŝŽŶĂů ůŝĂďŝůŝƚǇ ĐŽǀĞƌĂŐĞ ŝƐ ƉƌŽǀŝĚĞĚ͘

ƩĞŶĚŝŶŐ ƚŽ ŽǀĞƌ ϭϬϬ͕ϬϬϬ ƉĂƟĞŶƚ ǀŝƐŝƚƐ ĞĂĐŚ ǇĞĂƌ͕ ŽǇŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ƚĂŬĞƐ ƉƌŝĚĞ ŝŶ ŵĞĞƟŶŐ ƚŚĞ ŚĞĂůƚŚ ĐĂƌĞ ŶĞĞĚƐ ŽĨ h ŽĨ D ƐƚƵĚĞŶƚƐ͕ ƐƚĂī͕ ĂŶĚ ĨĂĐƵůƚǇ ǁŝƚŚ ĐŽŵƉĂƐƐŝŽŶ ĂŶĚ ƉƌŽĨĞƐƐŝŽŶĂůŝƐŵ͘

dŽ ůĞĂƌŶ ŵŽƌĞ͕ ƉůĞĂƐĞ ĐŽŶƚĂĐƚ ,ŽƐĞĂ KũǁĂŶŐ͕ ,ƵŵĂŶ ZĞƐŽƵƌĐĞƐ ŝƌĞĐƚŽƌ͕ Ăƚ 612-626-1184, hojwang@bhs.umn.edu ƉƉůǇ ŽŶůŝŶĞ Ăƚ ŚƩƉ͗ͬͬǁǁǁϭ͘ƵŵŶ͘ĞĚƵͬŽŚƌͬĞŵƉůŽǇŵĞŶƚ and ƐĞĂƌĐŚ ĨŽƌ ŬĞǇǁŽƌĚ 306981͘ dŚĞ hŶŝǀĞƌƐŝƚǇ ŽĨ DŝŶŶĞƐŽƚĂ ŝƐ ĂŶ ƋƵĂů KƉƉŽƌƚƵŶŝƚǇ͕ ĸƌŵĂƟǀĞ ĐƟŽŶ ĚƵĐĂƚŽƌ ĂŶĚ ŵƉůŽǇĞƌ͘

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MARCH 2016 MINNESOTA PHYSICIAN

ENTRESTO™ (sacubitril and valsartan) tablets, for oral use Initial U.S. Approval: 2015 BRIEF SUMMARY: Please see package insert for full prescribing information. WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) 1 INDICATIONS AND USAGE 1.1 Heart Failure ENTRESTO 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. 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 PRECAUTIONS 5.1 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 second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO. However, if there is no appropriate alternative to therapy with drugs affecting the reninangiotensin 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 Angioedema ENTRESTO may cause angioedema. In the double-blind period of PARADIGM-HF, 0.5% of patients treated with ENTRESTO and 0.2% of patients treated with enalapril had angioedema [see Adverse Reactions (6.1)]. If angioedema occurs, discontinue ENTRESTO immediately, provide appropriate therapy, and monitor for airway compromise. ENTRESTO must not be re-administered. In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/ adrenaline solution 1:1000 (0.3 mL to 0.5 mL) and take measures necessary to ensure maintenance of a patent airway. ENTRESTO has been associated with a higher rate of angioedema in Black than in non-Black patients. Patients with a prior history of angioedema may be at increased risk of angioedema with ENTRESTO [see Adverse Reactions (6.1)]. ENTRESTO should not be used in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy [see Contraindications (4)]. 5.3 Hypotension ENTRESTO lowers blood pressure and may cause symptomatic hypotension. Patients with an activated renin-angiotensin system, such as volumeand/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. In the double-blind period of PARADIGM-HF, 18% of patients treated with ENTRESTO and 12% of patients treated with enalapril reported hypotension as an adverse event [see Adverse Reactions (6.1)], with hypotension reported as a serious adverse event in approximately 1.5% of patients in both treatment arms. Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose. If hypotension occurs, consider dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia). If hypotension persists despite such measures, reduce the dosage or temporarily discontinue ENTRESTO. Permanent discontinuation of 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

MINNESOTA PHYSICIAN MARCH 2016

reported renal failure as an adverse event [see Adverse Reactions (6.1)]. In patients whose renal function depends upon the activity of the reninangiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt ENTRESTO in patients who develop a clinically significant decrease in renal function [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) in the full prescribing information]. As with all drugs that affect the RAAS, ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with renal artery stenosis, monitor renal function. 5.5 Hyperkalemia Through its actions on the RAAS, hyperkalemia may occur with ENTRESTO. In the double-blind period of PARADIGM-HF, 12% of patients treated with ENTRESTO and 14% of patients treated with enalapril reported hyperkalemia as an adverse event [see Adverse Reactions (6.1)]. Monitor serum potassium periodically and treat appropriately, 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 ENTRESTO may be required [see Dosage and Administration (2.1) in the full prescribing information]. 6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling 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 Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the PARADIGM-HF trial, subjects were required to complete sequential enalapril and ENTRESTO run-in periods of (median) 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing ENTRESTO and enalapril. During the enalapril run-in period, 1,102 patients (10.5%) were permanently discontinued from the study, 5.6% because of an adverse event, most commonly renal dysfunction (1.7%), hyperkalemia (1.7%) and hypotension (1.4%). During the ENTRESTO run-in period, an additional 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-in design, the adverse reaction rates described below are lower than expected in practice. In the double-blind period, safety was evaluated in 4,203 patients treated with ENTRESTO and 4,229 treated with enalapril. In PARADIGM-HF, patients randomized to ENTRESTO received treatment for up to 4.3 years, with a median duration of exposure of 24 months; 3,271 patients were treated for more than one year. Discontinuation of therapy because of an adverse event during the double-blind period occurred in 450 (10.7%) of ENTRESTO treated patients and 516 (12.2%) of patients receiving enalapril. Adverse reactions occurring at an incidence of ≥5% in patients who were treated with ENTRESTO in the double-blind period are shown in Table 1. Table 1: Adverse Reactions Reported in ≥5% of Patients Treated with ENTRESTO 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 both the enalapril and ENTRESTO run-in periods. In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril (0.5% and 0.2%, respectively). The incidence of angioedema in Black patients was 2.4% with ENTRESTO and 0.5% with enalapril [see Warnings and Precautions (5.2)]. Orthostasis was reported in 2.1% of patients treated with ENTRESTO compared to 1.1% of patients treated with enalapril during the double-blind period of PARADIGM-HF. Falls were reported in 1.9% of patients treated with ENTRESTO compared to 1.3% of patients treated with enalapril.

Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of >20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the doubleblind 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 both ENTRESTO- and enalapril-treated patients had increases in serum creatinine of >50%. Serum Potassium Potassium concentrations >5.5 mEq/L were observed in approximately 4% of patients in both the enalapril and ENTRESTO run-in periods. During the double-blind period, approximately 16% of both ENTRESTO- and enalapriltreated patients had potassium concentrations >5.5 mEq/L. 7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications (4)]. Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan. The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications (4)]. Avoid use with aliskiren in patients with renal impairment (eGFR <60 mL/min/1.73 m²). 7.2 Potassium-Sparing Diuretics As 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 potassium may 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 diuretic therapy), or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically. 7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary ENTRESTO can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. In animal reproduction studies, ENTRESTO treatment during organogenesis resulted in increased embryofetal lethality in rats and rabbits and teratogenicity in rabbits. When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO. However, if there 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. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the reninangiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates with histories of in utero exposure to ENTRESTO for hypotension, oliguria, and hyperkalemia. In neonates with a history of

in utero exposure to ENTRESTO, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Data Animal Data ENTRESTO treatment during organogenesis resulted in increased embryofetal 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 maximum recommended human dose [MRHD] of 97/103 mg twice-daily on the basis 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 and 0.06-fold the MRHD on the basis of valsartan and LBQ657 AUC, respectively). ENTRESTO is teratogenic based on a low incidence of fetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an ENTRESTO dose of ≥ 5 mg sacubitril/5 mg valsartan/kg/day. The adverse embryo-fetal effects of ENTRESTO are attributed to the angiotensin 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 basis of AUC) indicate that treatment with ENTRESTO during organogenesis, gestation and lactation may affect pup development and survival. 8.2 Lactation Risk Summary There is no information regarding the presence of sacubitril/valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Sacubitril/valsartan is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/ valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO. Data Following an oral dose (15 mg sacubitril/15 mg valsartan/kg) of [14C] ENTRESTO to lactating rats, transfer of LBQ657 into milk was observed. After a single oral administration of 3 mg/kg [14C] valsartan to lactating rats, transfer of valsartan into milk was observed. 8.4 Pediatric Use Safety 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 overall population [see Clinical Pharmacology (12.3) in the full prescribing information]. 8.6 Hepatic Impairment No dose adjustment is required when administering ENTRESTO to patients with mild hepatic impairment (Child-Pugh A classification). The recommended starting dose in patients with moderate hepatic impairment (Child-Pugh B classification) is 24/26 mg twice daily. The use of ENTRESTO in patients with severe hepatic impairment (Child-Pugh C classification) is not recommended, as no studies have been conducted in these patients [see Dosage and Administration (2.4) in the full prescribing information, Clinical Pharmacology (12.3) in the full prescribing information]. 8.7 Renal Impairment No 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) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) is 24/26 mg twice daily [see Dosage and Administration (2.3) in the full prescribing information, Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) in the full prescribing information]. 10 OVERDOSAGE Limited data are available with regard to overdosage in human subjects with ENTRESTO. In healthy volunteers, a single dose of ENTRESTO 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (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 be provided. ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2015-100 ENTRESTO is a trademark of Novartis AG Issued: July/2015

MARCH 2016 MINNESOTA PHYSICIAN

Use ENTRESTOâ&#x201E;˘ in place of ACEis and ARBs for HFrEF patients1 ENTRESTO was studied in the largest HF trial ever conducted2 â&#x20AC;˘ 7ULDO VWRSSHG HDUO\ GXH WR Ă&#x20AC; QGLQJ RI VLJQLĂ&#x20AC; FDQWO\ UHGXFHG ULVN RI &9 GHDWK DQG the primary end point being met3

ENTRESTO has been proven superior to enalapril, a current standard-of-care4 medication1 â&#x20AC;˘ Superiority vs enalapril, a standard-of-care ACEi therapy, across a range of NYHA class IIâ&#x20AC;&#x201C;IV patients with chronic HF and reduced ejection fraction REDUCED RISK OF CV DEATH OR FIRST HF HOSPITALIZATION VS ENALAPRIL1

ABSOLUTE RISK REDUCTION1

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

REDEFINE EXPECTATIONS IN HEART FAILURE

INDICATION ENTRESTO 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 WARNING: FETAL TOXICITY

â&#x20AC;˘ When pregnancy is detected, discontinue ENTRESTO as soon as possible â&#x20AC;˘ 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 is contraindicated in patients with a history of angioedema related to previous angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy. ENTRESTO is contraindicated with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor. ENTRESTO is contraindicated with concomitant use of aliskiren in patients with diabetes. Angioedema: ENTRESTO may cause angioedema. Angioedema associated with laryngeal edema may be fatal. ENTRESTO has been associated with a higher rate of angioedema in Black patients and in patients with a prior history of angioedema. If angioedema occurs, discontinue ENTRESTO immediately, provide appropriate therapy, and monitor for airway compromise. ENTRESTO must not be re-administered. Hypotension: ENTRESTO lowers blood pressure and may cause symptomatic hypotension. Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose. If hypotension persists despite dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia) reduce the dosage or temporarily discontinue ENTRESTO. Permanent discontinuation of therapy is usually not required. Impaired Renal Function: Decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO. In patients whose renal function depends upon the activity of the reninangiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt (175(672 LQ SDWLHQWV ZKR GHYHORS D FOLQLFDOO\ VLJQLĂ&#x20AC; FDQW GHFUHDVH LQ UHQDO IXQFWLRQ ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal 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 UHQDO IXQFWLRQ FRQFRPLWDQW XVH RI QRQ VWHURLGDO DQWL LQĂ DPPDWRU\ GUXJV 16$,'V LQFOXGLQJ &2; 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 treat appropriately, 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 ENTRESTO may be required. Concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, 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 during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO. Common Adverse Events: In a clinical trial, the most commonly observed adverse events with ENTRESTO vs 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 comparing ENTRESTO to enalapril in 8442 symptomatic (NYHA class IIâ&#x20AC;&#x201C;IV) adult HFrEF patients (left YHQWULFXODU HMHFWLRQ IUDFWLRQ Â&#x201D; $IWHU GLVFRQWLQXLQJ WKHLU H[LVWLQJ $&(L RU $5% WKHUDS\ SDWLHQWV entered sequential single-blind run-in periods during which they received enalapril 10 mg twice daily, 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 PRQWKV DQG SDWLHQWV ZHUH WUHDWHG IRU XS WR \HDUV 7KH SULPDU\ HQG SRLQW ZDV WKH Ă&#x20AC; UVW HYHQW LQ WKH FRPSRVLWH RI &9 GHDWK RU Ă&#x20AC; UVW +) KRVSLWDOL]DWLRQ 1 ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor blocker; HFrEF=heart failure with reduced ejection fraction; CV=cardiovascular; NYHA=New York Heart Association; HF=heart failure.

For more information, visit EntrestoHCP.com

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 in Prospective 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. Angiotensinâ&#x20AC;&#x201C;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 of the 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

ÂŠ 2015 Novartis

12/15

ETR-1321796