MN Physician June 2017

MINNESOTA

JUNE 2017

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXI, No. 3

A change to Minnesota law Licensure of for-profit HMOs

BY STEPHEN WARCH, JD, AND LINDSAY MCLAUGHLIN, JD, MPH

E

Addressing rising health care costs

BY GOVERNOR MARK DAYTON; SENATOR TONY LOUREY; REPRESENTATIVE CLARK JOHNSON; AND EMILY PIPER, JD

T

he cost of rising health insurance premiums along with large deductibles has hit Minnesotans hard and made health care unaffordable. To help more Minnesotans afford health care insurance premiums, a proposed buy-in would offer high-quality care at a reasonable cost.

Addressing rising health care costs to page 164

arly in the 2017 legislative session, the Minnesota Legislature passed a health insurance market reform bill that will change which companies can sell products in the state’s individual market by making it possible for for-profit entities to be licensed as HMOs under Chapter 62D (S.F. 1, 90th Leg., Reg. Sess. [Minn.

2017]). Since enacting the Health Maintenance Act of 1973, Minnesota law limited licensure of health maintenance organizations (HMOs) to nonprofit companies. Among other health insurance reform efforts in the bill, some legislators hope this change will encourage more competition in the Minnesota health insurance market, in turn increasing health insurance product options for Minnesotans while lowering their health insurance premiums.

However, other legislators have expressed concerns that the business model of for-profit HMOs will A change to Minnesota law to page 184

YOU, TWO HEALTHCARE ARCHITECTURE | OWNER’S REPRESENTATION At JLG, we have a healthy interest in helping you build your best medical system.

So whether you need one of the top healthcare designers in the region to work with you to create the plan or another set of eyes to represent you through the construction process, JLG Architects is always here for you.

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MINNESOTA HEALTH CARE ROUNDTABLE

JUNE 2017

|

REGENERATIVE MEDICINE:

Volume XXXI, Number 3

Efficacy, Economics, and Evolution

COVER FEATURES Addressing rising health care costs

A change to Minnesota law Licensure of for-profit HMOs

By Governor Mark Dayton; Senator Tony Lourey; Representative Clark Johnson; and Emily Piper, JD

By Stephen Warch, JD, and Lindsay McLaughlin, JD, MPH

DEPARTMENTS CAPSULES

10

MEDICUS

13

INTERVIEW

14

Making quality health care accessible

Alan Spiro, MD, MBA, Medica Health Plans

MEDICINE AND THE LAW 40 One year after Prince’s death Time for increased accountability

Thursday, November 2, 2017 • 1-4 PM

By Chris Johnson, MD, and Senator Chris Eaton, RN

Symphony Room III, Downtown Minneapolis Hilton and Towers

BACKGROUND AND FOCUS:

2017 HEALTH CARE ARCHITECTURE HONOR ROLL Eleven outstanding building projects

26

By Lisa McGowan

SPECIAL FOCUS: MEDICAL FACILITY DESIGN Shedding new light on health care Rethinking lighting design

20

By Renaldo Pesson, NCIDQ, IIDA, AAIA Building new health care facilities How to plan for a successful project

22

By Richard P. Engan, AIA, LEED AP, CID, and Mitra Milani Engan Antimicrobial materials in health care facilities Creating more harm than good?

Several recent studies have reached troubling conclusions. A huge percentage of prescription medications produce little to no therapeutic benefit for many patients. In large part this relates to a drug development paradigm and medical care model centered more on treating symptoms than curing root causes. An emerging solution to this problem is the field of regenerative medicine—an approach that directly repairs or replaces damaged tissues and organs. Though initial research and development costs present significant upfront investment, the promise of better outcomes and eventual savings are impossible to ignore.

24

OBJECTIVES:

We will define regenerative medicine and trace its development. We will explore what the pharmaceutical, device, and insurance industries are doing now with regenerative medicine and how they can work together moving forward. We will discuss the challenges that face regenerative medicine and offer potential solutions. We will look ahead so that, as we enter the third decade of the 21st century, the pace of innovation can expand in a way that is accessible, affordable, and sustainable.

By Sandra J. Christie, AIA, LEED AP BD+C Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 7288600, by fax at (612) 728-8601, on our website (mppub.com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406.

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MINNESOTA PHYSICIAN JUNE 2017

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JUNE 2017 MINNESOTA PHYSICIAN

It clicked when my doctor and I discussed Trulicity ÂŽ1,2

Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy that offers unbeaten A1C reduction*, once-weekly dosing, and the Trulicity pen.1,3 If you have patients who struggle with the idea of adding an injectable, consider Trulicity as an option for the next step in their care.1,4 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction. *In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose.1,3

For more information on clinical trials, see the following page.

Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks.

Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy.

Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease.

Select Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure.

It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on inside spread and accompanying Brief Summary of Prescribing Information.

Please see Instructions for Use included with the pen.

Learn about unbeaten A1C reduction at Trulicity.com

MINNESOTA PHYSICIAN JUNE 2017

5

Unbeaten A1C reduction* with fewer injections 1,3

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

Trulicity vs Victoza®

3

Add-on to metformin (26 weeks) 8.1

Mean Baseline A1C (%)

8.1

Trulicity vs Lantus®

Trulicity vs Byetta®

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

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

1,5

8.1

8.2

8.1

1,6

8.1

8.1

8.1

8.1

0.0

Two efficacious doses available1 Mean A1C change from baseline (%)

The recommended starting dosage of Trulicity is 0.75 mg once a week

-0.2

-0.5

-0.4

-0.6

-0.6

-0.8

-0.8

-1.0

-1.1

-1.0

-1.3

-1.2

-1.4

-1.4

-1.4

-1.5

-1.6 For patients requiring additional glycemic control, the dosage may be increased to 1.5 mg once a week

Trulicity (1.5 mg)

Trulicity (0.75 mg)

Trulicity (0.75 mg)

Victoza (1.8 mg)

Trulicity (1.5 mg)

Trulicity (1.5 mg)

Lantus

Byetta (10 mcg BID) Placebo

Data represent least-squares mean.

APPROXIMATE TOTAL INJECTIONS

APPROXIMATE TOTAL INJECTIONS

APPROXIMATE TOTAL INJECTIONS

26 182

52 365

26 365

Study Descriptions Compared to Victoza3

Victoza 1.8 mg QD, SC (n=300); Trulicity 1.5 mg QW, SC (n=299)

Compared to Lantus1,5 •

Lantus QD, SC (n=262); Trulicity 0.75 mg QW, SC (n=272); Trulicity 1.5 mg QW, SC (n=273)

Compared to Byetta1,6

•

•

•

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

•

78-week, randomized, open-label comparator phase 3 study (double-blind with respect to Trulicity dose assignment) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Amaryl (≥4 mg/day)

Placebo (n=141); Byetta 10 mcg BID, SC (n=276); Trulicity 0.75 mg QW, SC (n=280); Trulicity 1.5 mg QW, SC (n=279)

•

52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos (up to 45 mg/day)

•

Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided alpha level of 0.025; analysis of covariance using last observation carried forward); primary objective met

•

Key secondary objectives of superiority of both Trulicity doses on A1C change from baseline vs Byetta were met

•

•

Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline at 26 weeks (-1.42% vs -1.36%, respectively; difference of -0.06%; 95% CI [-0.19, 0.07]; 2-sided alpha level of 0.05 for noninferiority with 0.4% margin; mixed-model repeated measures analysis) Primary objective of noninferiority for A1C reduction was met; secondary endpoint of superiority was not met

•

•

Starting dose of Lantus was 10 units daily. Lantus titration was based on self-measured fasting plasma glucose utilizing an algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint. Mean daily dose of Lantus was 29 units at the primary endpoint Primary objective was to demonstrate noninferiority of Trulicity 1.5 mg vs Lantus on A1C change from baseline at 52 weeks (-1.1% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using last observation carried forward); primary objective met

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

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JUNE 2017 MINNESOTA PHYSICIAN

Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

The most common adverse reactions (excluding hypoglycemia) reported in ≥5% of Trulicity-treated patients in placebo-controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%), diarrhea (6.7%, 8.9%,12.6%), vomiting (2.3%, 6.0%,12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%).

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

Pregnancy: Limited data with Trulicity in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide. Use only if potential benefit justifies the potential risk to the fetus.

Lactation: There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition.

Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

DG HCP ISI 06FEB2017

Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.

Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions and angioedema) in patients treated with Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist as it is unknown whether they will be predisposed to anaphylaxis with Trulicity.

Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions.

Please see Brief Summary of Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages.

Please see Instructions for Use included with the pen.

Trulicity® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Trulicity is available by prescription only.

Actos® is a registered trademark of Takeda Pharmaceutical Company Limited.

Byetta® is a registered trademark of the AstraZeneca group of companies.

Amaryl® and Lantus® are registered trademarks of Sanofi-Aventis.

Victoza® is a registered trademark of Novo Nordisk A/S. Other product/company names mentioned herein are the trademarks of their respective owners.

References 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014.

3. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet.

2014;384:1349-1357.

4. Polonsky WH, Hajos TR, Dain MP, Snoek FJ. Are patients with type 2 diabetes reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population. Curr Med Res Opin. 2011;27(6):1169-74. doi: 10.1185/03007995.2011.573623.

Epub Apr 6, 2011.

5. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care.

2015;38(12):2241-2249.

6. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) [published correction appears in Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37:2159-2167.

Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity.

PP-DG-US-0856

03/2017

©Lilly USA, LLC 2017. All rights reserved.

MINNESOTA PHYSICIAN JUNE 2017

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Trulicity® (dulaglutide) Brief Summary: Consult the package insert for complete prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS • In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

• Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

ADVERSE REACTIONS

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

Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Pool of Placebo-controlled Trials: These data reflect exposure of 1670 patients to Trulicity and a mean duration of exposure to Trulicity of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations.

Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Trulicity-Treated Patients: Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5 mg (N=834) (listed as placebo, 0.75 mg, 1.5 mg): nausea (5.3%, 12.4%, 21.1%), diarrheaa (6.7%, 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%, 4.2%, 5.6%). (a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.) Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.75 mg and 1.5 mg of Trulicity as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively. In addition to the adverse reactions ≥5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%; 3.9%; 3.7%), flatulence (1.4%; 1.4%; 3.4%), abdominal distension (0.7%; 2.9%; 2.3%), gastroesophageal reflux disease (0.5%; 1.7%; 2.0%), and eructation (0.2%; 0.6%; 1.6%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of Trulicity as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3342 patients with type 2 diabetes were treated with Trulicity for a mean duration 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as ≥5% above. Other Adverse Reactions: Hypoglycemia: Incidence (%) of Documented Symptomatic (≤70 mg/dL Glucose Threshold) and Severe Hypoglycemia in Placebo-Controlled Trials: Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), Trulicity 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5 mg: 5.0%; Severe: all 0. Add-on to Glimepiride at 24 weeks, Placebo (N=60), Trulicity 1.5 mg (N=239), Documented symptomatic: Placebo: 1.7%, 1.5 mg: 11.3%; Severe: all 0. Add-on to Insulin Glargine with or without Metformin at 28 weeks, Placebo (N=150), Trulicity 1.5 mg (N=150), Documented symptomatic: Placebo: 30.0% 1.5 mg: 35.3%; Severe: Placebo: 0% 1.5 mg: 0.7%. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. In a 78-week clinical trial documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented

Trulicity® (dulaglutide)

Trulicity® (dulaglutide)

INDICATIONS AND USAGE Trulicity® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease.

CONTRAINDICATIONS Do not use in patients with a personal or family history of MTC or in patients with MEN 2.

Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components.

WARNINGS AND PRECAUTIONS

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Trulicity and other suspected medications and promptly seek medical advice. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with Trulicity. Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal failure, use caution when initiating or escalating doses of Trulicity in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity.

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symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with prandial insulin. Severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg, and 1.5 mg, respectively, was co-administered with prandial insulin. Heart Rate Increase and Tachycardia Related Adverse Reactions: Trulicity 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm). The long-term clinical effects of the increase in HR have not been established. Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to Trulicity. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively.

Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4%, and 1.6% of patients treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3%, and 2.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively.

Immunogenicity: Across four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) Trulicitytreated patients developed anti-drug antibodies (ADAs) to the active ingredient in Trulicity (ie, dulaglutide). Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies against native GLP-1.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products. Hypersensitivity: Systemic hypersensitivity adverse reactions sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and Phase 3 studies. Injection-site Reactions: In the placebo-controlled studies, injection-site reactions (eg, injection-site rash, erythema) were reported in 0.5% of Trulicity-treated patients and in 0.0% of placebo-treated patients. PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) Block: A mean increase from baseline in PR interval of 2-3 milliseconds was observed in Trulicity-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with Trulicity than placebo (0.9%, 1.7%, and 2.3% for placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5%, and 3.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Amylase and Lipase Increase: Patients exposed to Trulicity had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebotreated patients had mean increases of up to 3%. Postmarketing Experience: Anaphylactic reactions have been reported during post-approval use of Trulicity. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

DRUG INTERACTIONS Trulicity slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to any clinically relevant degree.

USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary Limited data with Trulicity in pregnant women are not sufficient to determine a drug associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 14-times human exposure at the maximum recommended human dose (MRHD) of 1.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 13-times human exposure at the MRHD. Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide.

Lactation: Risk Summary There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition. Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years. Geriatric Use: In the pool of placebo- and active-controlled trials, 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations. In a clinical pharmacology study in subjects with Trulicity® (dulaglutide)

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varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. Renal Impairment: In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicity-treated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2).

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

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

PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide • Inform patients that Trulicity causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician. • Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Trulicity promptly, and to contact their physician, if persistent severe abdominal pain occurs.

• The risk of hypoglycemia may be increased when Trulicity is used in combination with a medicine that can cause hypoglycemia, such as a sulfonylurea or insulin. Review and reinforce instructions for hypoglycemia management when initiating Trulicity therapy, particularly when concomitantly administered with a sulfonylurea or insulin. • Patients treated with Trulicity should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with Trulicity of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs. • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of Trulicity and other GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, patients must stop taking Trulicity and seek medical advice promptly. • Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant. • Prior to initiation of Trulicity, train patients on proper injection technique to ensure a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inform patients of the potential risks and benefits of Trulicity and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and advise patients to seek medical advice promptly. • Each weekly dose of Trulicity can be administered at any time of day, with or without food. The day of once-weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before. If a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, it should be administered as soon as possible. Thereafter, patients can resume their usual once-weekly dosing schedule. If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, the patient should not administer the missed dose and instead resume Trulicity with the next regularly scheduled dose. • Advise patients treated with Trulicity of the potential risk of gastrointestinal side effects. • Instruct patients to read the Medication Guide and the Instructions for Use before starting Trulicity therapy and review them each time the prescription is refilled. • Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. • Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range.

HbA1c is especially useful for evaluating long-term glycemic control.

Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2014, 2015, Eli Lilly and Company. All rights reserved.

Additional information can be found at www.trulicity.com DG HCP BS 10FEB2017 Trulicity® (dulaglutide)

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HealthEast Partners with Woodbury Sports Center The Woodbury City Council has approved a plan with HealthEast through which the health care system will contribute funds to and offer community outreach at the Bielenberg Sports Center.

HealthEast will provide $126,785 annually to the center for 14 years, for a total of $1.77 million, and offer health education, health screenings, and healthy activities to the 360,000 people who visit the center each year.

The city will use the funds to continue supporting active lifestyles, and plans to request community input for ideas.

“There is no timeline in place for this process; however, it will include a public comment period for residents to share their ideas,” said Clint Gridley, Woodbury city administrator.

The Bielenberg Sports Center will also undergo a name change. Currently, it is named for the first mayor of Woodbury. That will change to the HealthEast Sports Center, with the blessing of the Bielenberg family. HealthEast will not have a clinic

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within the facility, and the Summit Orthopedics location will stay put.

HealthEast has the option to extend the agreement after the 14 years is up.

Mayo Clinic Mate-Pair Sequencing Test Now Available A new, first of its kind clinical test to help patients who may be at a diagnostic dead end with other genetic testing is now available at Mayo Clinic. The mate-pair sequencing test can identify chromosome alterations, or breakpoints, involved in chromosome rearrangements, which pinpoints the exact genes involved.

“Until now, this type of test was not available for clinical use,” said Robert Jenkins, MD, PhD, pathologist and cancer geneticist at Mayo Clinic. “The assay can be really useful in knowing which genes are at those breakpoints because current chromosome studies cannot provide that level of resolution.”

The test examines all 23 pairs of chromosomes. Mayo hopes it will help clinicians and patients avoid

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unnecessary and potentially expensive testing when they are searching for chromosome abnormalities. It could also identify previously unknown alterations that may help determine diagnoses and shift treatments.

According to Mayo Clinic, the test is especially useful for cancer researchers to understand the underlying biology of a patient’s tumor. By knowing the nature of the gene arrangement, they can change the way a patient’s cancer care is managed.

“Being able to put disease types into diagnostic categories is important to patients,” said Jenkins.

The test is available to patients at Mayo Clinic as well as health care providers around the world through Mayo Medical Laboratories.

“Our mate-pair sequencing technology is transformative, allowing genomic information critical to patient care to be determined comprehensively, accurately, and quickly,” said George Vasmatzis, PhD, co-director of the Biomarker Discovery Program at the Mayo Clinic Center for Individualized Medicine and a genomicist who is the primary developer of the software and experimental

procedures that led to the test. “Our program is working closely with the Mayo Clinic Medical Genome Facility and the Department of Laboratory Medicine and Pathology to explore additional mate-pair next-generation sequencing applications.”

Most Medical Cannabis Patients Report Benefits Early data from the Minnesota Department of Health (MDH) shows that a majority of patients that used Minnesota’s medical cannabis program benefitted during its first year.

The study is based on data enrollment, purchasing and related health information, and survey results to describe the experience of patients who were enrolled in the medical cannabis program during its first year, from July 1, 2015, through June 30, 2016.

During that period, a total of 1,660 patients participated with a total of 16,238 product purchases.

The survey asked patients how much benefit they received from using medical cannabis on a scale from one to seven, with one indicating no

Ph ys HealthPartners has entered a partnership with Welltok, a consumer health technology company, to offer a customizable online health platform to its members. Previously, the health care system used an in-house wellness platform for a decade.

The program has launched for 157,000 individual and small group members and will be extended to more than 200,000 enrolled in commercial large group plans in 2018.

Participants can create custom health goals for diet, exercise, or specific health conditions, and receive information on costs for services like

Rice Memorial Hospital’s board of directors and Affiliated Community Medical Centers’ (ACMC) shareholders have unanimously agreed to a letter of intent to partner with CentraCare Health. It is the first step to creating a new nonprofit regional health system that would collaboratively provide health and wellness services for patients in West Central and Southwest Minnesota.

The partnership does not mean an ownership change, however— Rice Memorial Hospital would continue to be city-owned. Patients will not notice much of a change, however the agreement would allow the systems to be in a better position for future health plan contracts.

The organizations will now begin a process of gaining approval from key stakeholders. The Willmar City Council, which has the final say over the city-owned Rice Memorial Hospital, is expected to review the issue in early June. The timeline calls for finalizing the agreement by the end of 2017 and launching the new entity in 2018.

Rice Memorial Hospital is a Level 3 Trauma hospital with about 1,000 employees at its hospital, nursing home, and medical equipment company; ACMC has 110 physicians and more than 1,100 employees at its nine sites; and CentraCare Health has six hospitals, 19 medical clinics, four pharmacies, six nursing homes, and six senior housing communities. Rice Memorial Hospital and ACMC jointly own Willmar Medical Services, which has about 300 employees.

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ACMC, Rice Memorial Hospital to Partner with CentraCare

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HealthPartners Offers New Online Wellness Program

visiting the emergency room or where to go for the most affordable care based on their coverage.

on iti

benefit and seven indicating a great deal of benefit. Results showed that 64 percent of patients reported a benefit rating of six or seven. When asked about symptom reduction, patients reported achieving at least a 30 percent reduction in symptoms for conditions including seizures, Tourette syndrome, Crohn’s disease, and muscle spasms—an amount that is considered clinically meaningful. Between half and two-thirds of patients who reported achieving clinically meaningful improvement also reported that they retained that degree of improvement over four months for most symptoms. On the other end of the scale, 9 percent of patients reported little or no benefit, with ratings of one, two, or three. Overall, patients reported that affordability is still an issue because medical cannabis is not covered by health insurance.

The 577 participating health care practitioners were surveyed as well.

Their results were more conservative, with 38 percent indicating a rating of six or seven, and 23 percent indicating a rating of one, two, or three.

However, MDH notes that patients cite quality of life benefits more often than practitioners, who appear to focus on more objective measures such as the number of seizures a patient experiences.

“Based on this evidence from the first year, Minnesota’s approach is providing many people with substantial benefits, minimal side effects, and no serious adverse events,” said Ed Ehlinger, MD, Minnesota commissioner of health.

Research Reco n a gn ici

2017

REQUEST FOR NOMINATIONS This August, Minnesota Physician will publish a feature recognizing physician-directed medical research projects. We invite nominations from our readers. If you or an associate are currently engaged in a medical research project, please contact us, either by phone or through the form below. The research may be from any field and conducted on any level— basic, clinical, community-based, epidemiological, health services-related, etc. The only criterion is that the principal investigator(s) is an MD. Whether the research is conducted in an academic institution, a rural or urban clinic or hospital, a managed-care organization, health system foundation, corporation, or state agency, we welcome its nomination.

We will feature as many projects as possible, representing a geographically and institutionally diverse sample.

Thank you for your participation. We welcome your assistance in recognizing Minnesota’s outstanding medical research community.

To submit online: https://www.surveymonkey.com/r/PhysicianResearch

Name of project: Research site: Funder: Principal investigator(s): Phone and/or email): Comments:

St. Scholastica Launches Physician Assistant Program The Accreditation Review Commission on Education for the Physician Assistant has granted Accreditation–Provisional Status to the College of St. Scholastica’s physician assistant program in Duluth. The program was originally planned to launch in

Send to:

Minnesota Physician Publishing 2812 East 26th Street, Minneapolis, MN 55406

612-728-8600 • Fax: 612-728-8601 • amarlow@mppub.com

Please note: All nominations must be received by June 15, 2017 and will be held in confidence. We will contact you and no information will be published without approval from the PI(s).

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CAPSULES

2016, but the school decided to wait a year to seek accreditation in order to ensure everything was in place and done well.

The first class of 30 students will begin the program in September.

That number will grow to 34 next year and 38 the following year. Students who are accepted into the program will experience classroom and lab training during the fall, spring, and summer semesters of their first year and be assigned to month-long clinical rotations in their second year.

Those who graduate from the twoyear program will receive a master’s degree in physician assistant studies.

The program was developed in collaboration with health care providers in the region to help meet a growing need for care providers as the demand for non-physician health care providers continues to boom, particularly in rural areas where physicians are especially scarce. Employment for physician assistants is expected to increase by 30 percent in the U.S. by 2024, according to the Bureau of Labor Statistics.

“There are about 60 PA positions open in northern Minnesota right

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now,” said Kim Kruger, MD, MBA, chairperson of the physician assistant program. “And that growth is going to continue. It’s a 40 percent growth rate annually.”

Most of the graduates are expected to practice in the five-state region, primarily in Minnesota and Wisconsin and in underserved urban or rural settings.

Three other schools in Minnesota currently offer physician assistant programs in the metro area. St. Scholastica’s program is now the only physician assistant program north of the Twin Cities.

patients,” said James Hereford, president and CEO of Fairview. “We’re planning a thoughtful integration process that will unfold over time.”

Hereford will lead the newly combined system, while current HealthEast CEO, Kathryn Correia, will step into the role of chief administrative officer. The existing Fairview board of directors will govern the system, with the addition of three current HealthEast board members.

Fairview and HealthEast Merger Finalized

St. Francis Regional Medical Center in Shakopee has begun offering acupuncture to patients who visit its emergency room to reduce the overall need for pain medication. The service is provided at no cost to patients, as it’s funded through the Saints Healthcare Funds, and is available to all patients in the emergency room who are experiencing pain from minor migraines to significant trauma. More than 30,000 patients visit the facility’s emergency room each year.

The boards of directors at Fairview Health Services and HealthEast have approved the final agreement for HealthEast to become part of the Fairview system after announcing initial plans for the merger in March.

The agreement is effective June 1.

“Joining forces will ultimately enable us to deliver even better care with a broader range of services for our

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Shakopee Medical Center Offers Free Acupuncture to ER Patients

The treatment stimulates natural endorphins in the body to promote better circulation and natural healing. The health care center notes that a study from the Penny George Institute for Health and Healing showed that emergency room patients who receive acupuncture experienced significant reductions in pain and anxiety. They hope this alternative service will replace opioid prescriptions for many patients.

“Ninety-one Americans die every day from an opioid overdose; it’s a national epidemic. Offering acupuncture in our emergency department is one way for St. Francis to decrease incidences of prescribed opioids and help be a part of the solution,” said Brian Clarkowski, MD, emergency department medical director at St. Francis Regional Medical Center. “We are proud to be among the first emergency departments in the nation to provide this treatment to our patients.”

Acupuncture is also offered to patients as part of its integrative health program, and is provided to cancer patients while receiving chemotherapy treatments to help reduce anxiety, pain, and nausea.

MEDICUS

Claire Bender, MD, has received the inaugural Champion of Allied Health Award from the Mayo Clinic School of Health Sciences Alumni Association for her contributions toward promotion, advocacy, and advancement associated with allied health professions. Bender served as dean of the school from 2002 to 2014. During that time, she led changes that helped professionalize the school and allied health careers, including playing a pivotal role in establishing a University of Minnesota campus in Rochester and developing a Bachelor of Science in Health Professions degree at the university. She also led development of blended learning, which combines online and in-person instruction, and interprofessional education. Bender now serves as a supplemental retired consultant in the Department of Radiology at Mayo Clinic and a professor of radiology. She earned her medical degree at the University of Nebraska College of Medicine and completed a radiology residency at Mayo Clinic before joining the staff.

Apostolos Georgopoulos, MD, PhD, has received the 2017 Immigrant of Distinction Award from the American Immigration Lawyers Association for his significant contributions to health care. The award is given to professionals that exemplify the benefit that immigrants play in American health care, science, and moral character. Georgopoulos was honored for his significant contributions to brain sciences and post-traumatic stress disorder (PTSD). He serves as a professor of neuroscience, neurology, and psychiatry in the department of neuroscience at the University of Minnesota Medical School and director of the Universityâ&#x20AC;&#x2122;s Center for Cognitive Sciences. He earned his medical degree and PhD degree at the University of Athens in Greece and was trained in neurophysiology at Johns Hopkins Hospital. He has received a number of prominent awards in his discipline for his findings in the link between genetics and PTSD. Jonathan Braman, MD, physician at TR I A Orthopaedic Center, and Brett Freedman, MD, orthopedic spine surgeon with Mayo Clinic, were chosen by the American Orthopaedic Association to take part in the 2017 American-British-Canadian (ABC) Traveling Fellowship. They are two of five physicians from North America that were selected.

The fellowship takes place over five weeks and includes travel to two continents and throughout several countries including Scotland, England, and South Africa. Participants visit orthopedic centers, present lectures on their research, attend other participantsâ&#x20AC;&#x2122; lectures, and complete operating room and clinical observances. They began their journey in late April.

Braman earned his medical degree at the University of Washington School of Medicine and Freedman earned his medical degree at the University of Illinois College of Medicine.

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INTERVIEW

Making quality health care accessible Alan Spiro, MD, MBA, Medica Health Plans As chief medical officer at Medica, what kind of projects are you working on?

Health care and health care benefits are in the midst of dramatic changes in funding, in financial risk management, and in the role that health plans play in the delivery of health care.

As CMO, I play a major role in helping Medica develop and implement priorities that address this rapidly changing landscape. These priorities cover a wide range of projects that include modifications to pharmacy use and costs, our partnerships with health systems and clinicians, and our approach to helping members through the increasing complexity and fragmentation of health care. This includes how we can best help people find the right access to precision or personalized medicine and how we can individualize our approach to meet the unique social and medical needs of each of our members.

Today’s health insurance industry is only part “insurance” with the bulk of coverage being prepaid health care rather than true insurance. When the risk pools cannot be properly defined because they are changing, it makes it virtually impossible to price coverage correctly, as we are witnessing in the market.

While often beneficial to the medical community and patients, the advent of new technologies and methodologies can make this even more challenging.

Precision or personalized medicine is a perfect

How can we best address the issue of increasingly specialized medications, with increasingly high costs?

As the health care needs of members become more complex and comorbidities increase, the need for these specialized medications is very real.

Pharmacological advances and cost increases are a related, complex consideration for physicians, patients, and health plans. I think we will ultimately have to develop better reinsurance products that address extremely high-cost medications.

Currently, we are on a path where one medication could literally bankrupt a small health plan. We do, however, have to acknowledge the tremendous medical advances that these drugs represent. Their use can improve lives and lower hospitalization costs and other medical costs, so we must be careful to measure these factors very carefully.

Social disparities in health care have come into increasing focus. How do you address these concerns?

Social disparities provide objective measures that we can use to explore how social factors influence medical care and medical decision making. The opportunity and challenge for health insurers is to better measure not only how disparities affect medical results, but to develop metrics on specific social factors, such as economic status and culture.

This helps us develop approaches to ensure that people obtain health care that acknowledges social factors as elements of the patient’s condition. The fact is that health care, from the patient and family point of view, is less about biology and more about the impact that illness has on a person’s ability to live their life the way that they would like. Properly measuring the social factors holds the potential to both improve the delivery of health care for all and to lower health care costs for all.

What are the biggest challenges facing the health insurance industry today?

The challenges are immense as the governmental regulatory framework for health care is in extreme flux. There are great uncertainties in the rules that govern health plans, which makes the management of financial risk more challenging. Fundamentally, health insurance is pooling financial risk against unusual and often catastrophic medical events.

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Minnesota as HMOs may create only marginal changes in the competitive landscape. For-profit insurers already provide coverage for employers and other commercial customers. In the current environment, potential new markets available to for-profit insurers—the individual market and government programs such as Medicaid—may not be seen as highly desirable for insurers. Also, in the end, the health systems have the true power to decide how they will respond to the change in law as they decide which plans to contract with.

Fundamentally, “...” our job is to make quality health care accessible.

How can precision medicine lower the cost “...” of care?

example of such advancement. Many of the newer genetically engineered drugs that target very specific subsets of disease, such as a cancer with a certain genetic marker, also make the potential market for the drug smaller. In response, the drug manufacturers have priced some of these drugs extremely high. One patient can therefore make a dramatic effect on the financial viability of a plan.

Precision or personalized medicine can improve the specificity of treatments and also avoid medication complications. There is tremendous patient variability in the response to pharmacologic agents (drugs), many of which are due to genetic factors. In the long run, these can decrease costs by improving patient outcomes faster. It is important to recognize, however, that the required lab tests and specific drugs that precision medicine may lead to could be priced so high that costs actually increase.

What do you foresee from the recent legislative changes around for-profit health insurers operating in Minnesota?

There is much uncertainty surrounding health care in today’s political climate.

What concerns you?

I honestly don’t know. The changes that allow for-profit health insurers to operate in

Health care is related to mental health care and social care. While parity laws address medical

and behavioral health, the social needs are often paramount and must also be addressed. Neither the care delivery systems nor the health benefits systems are equipped to deal with these social issues and this must be addressed through undoubtedly challenging conversations. These conversations will be extremely difficult in a highly politicized environment in which it seems the goal is to demonize the opposition instead of to find the right solutions. Until the political parties realize that their goal is to find solutions and not just be concerned with sound bites, the uncertainty will remain.

What do you see as the most important ethical issues in health care?

Health care is one of the most personal endeavors that exist. The tension between individual autonomy and privacy, and the need to have common data systems and consistent rules, is an ethical challenge. In addition, there is a tension between individual ethics and group ethics. Itâ&#x20AC;&#x2122;s not ethical to withhold treatment from someone because of their age. At the same time, from a group ethics point of view, questions must be asked if that treatment costs $1 million and the end result is uncertain or might have limited benefit for a

relatively brief period of time. Is it ethical to have $1 million fewer dollars to spend on maternity care to avoid sick newborns? We must find ways to accommodate both.

If you could change one thing about how the health care delivery system works today, what would it be?

In my opinion, no perfect system exists. I would, however, insist on more participatory and collaborative decision-making by the health care professional and the patient. Health care decisions are ultimately up to the patient, but it is critical that they be informed decision-makers. A health care professional can help guide a patient and provide the necessary education for such decisions.

The decisions are also never made in a vacuum. For most people, their family well-being can be more important than their own physical well-being. That autonomy must be respected in any system.

What would you like physicians to know about what is happening at Medica?

Fundamentally, our job is to make quality health care accessible. Part of this requires that health premiums be affordable. Every employee, including the health professionals, physicians,

nurses, pharmacists, and therapists who work at Medica, come to work every day with the goal of helping people navigate through what can be a very complex health care system. Our ultimate goal is to ensure that we are making optimal care affordable and available to as many people as we can.

Alan Spiro, MD, MBA, is senior vice president and chief medical officer at Medica Health Plans.

He oversees all Medica efforts aimed at improving the quality of health care while managing costs and he emphasizes new models of collaboration to achieve those goals. His experience includes executive roles at health plans and health services businesses, as well as in clinical practice. Prior to joining Medica, Dr. Spiro served as executive vice president, chief medical officer, and chief health assistant for Accolade Inc., which provides specialized, on-demand health care services to employers, health plans, and health systems. He holds degrees from the Columbia University College of Physicians and Surgeons and the Northwestern University Kellogg School of Management.

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ADDRESSING RISING H Expanding choices for Minnesotans

BY GOVERNOR MARK DAYTON; SENATOR TONY LOUREY; AND REPRESENTATIVE CLARK JOHNSON

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ince 1859, the Sexton family has owned and operated the Irish Ridge Dairy Farm in Millville, about 25 miles northeast of Rochester. Sheri and Vince Sexton run the family dairy today.

Like generations before them, Sheri and Vince work hard every day to produce high-quality milk and dairy products to provide better lives for themselves and their family. But rising health insurance costs have thrown them into a financial crisis. Like most farmers, the Sextons have always purchased their own health insurance on the individual market.

Last year, they paid $1,580 a month for their health coverage. This year, their premiums went up 40 percent, to $2,200 per month. Altogether, the Sextons are paying $26,400 in premiums this year, for a policy with a $13,000 deductible. Thanks to the premium relief authorized in late January, Sheri and Vince will save about $6,600 on their annual premiums this year. But even with that relief, they will still pay almost $20,000 for a health policy they can barely afford to use.

The Sextons’ story is not unique. Many thousands of hard working Minnesotans have been saddled with steep health insurance premium increases and huge deductibles—making quality health care unaffordable.

Their experiences show how urgent this problem is, and why we must work together to help the Sextons and so many other Minnesotans afford the quality health care they need, at prices they can afford. Sheri and Vince told us, “Something has to change.” We agree. And we have a solution.

Offering affordable health coverage In 1992, Governor Arne Carlson and legislators from both parties created MinnesotaCare—a state-operated health insurance plan that now provides over 107,000 Minnesotans with affordable health coverage for themselves and their families. With less than 3 percent in annual overhead, MinnesotaCare has proven that it can be run with more efficiency and accountability than many commercial plans now being sold on the individual market. It is a nation-leading, bipartisan solution that has worked in Minnesota for 25 years.

We believe that Minnesotans should have the freedom to buy their health insurance through MinnesotaCare. Their premiums would cover the full cost of their policies, so there would be no ongoing subsidies from the state. The MinnesotaCare “Buy-in Option” would provide a more affordable choice for another 100,000 Minnesotans, who now buy coverage for themselves or their families on the individual market.

Another strong benefit of this proposal, particularly for Minnesotans in rural areas of the state, is the broad networks of physicians and care providers available through MinnesotaCare. Allowing more Minnesotans to buy in to MinnesotaCare would offer many families a real option to choose their doctor. This is in stark contrast to the single, narrow network of insurance products available in large sections of the state.

MinnesotaCare is the answer

Bringing advanced day treatment closer to home Rogers Behavioral Health offers specialized outpatient care for kids and adults with OCD and anxiety, and adults with depression and other mood disorders. And we’ve just added posttraumatic stress disorder services for adults.

Coming June 2017: Eating disorders services for kids and teens.

Republicans, Democrats, and all Minnesotans agree: we need more affordable health insurance. We also agree that there needs to be more competition to give consumers better choices while purchasing the coverage they need at prices they can afford. We ought to take our lesson from a program— MinnesotaCare—that has worked successfully for decades, and now gives more Minnesotans the choice to purchase this high-quality insurance at lower prices. It is time for a real solution to rising health insurance costs.

That is what Minnesotans expect. That is what they deserve.

We encourage you to contact your state senators and representatives, and voice your support for the MinnesotaCare buy-in proposal.

Governor Mark Dayton is Minnesota’s 40th Governor. In 2015 and 2017, he was appointed by the President of the United States to serve on the Council of Governors.

Senator Tony Lourey was elected to the Minnesota Senate in 2006 and Call 844-599-8959 or go to rogersbh.org to learn more.

6442 City West Parkway, Suite 200, Eden Prairie, MN 55344

re-elected in 2010, 2012, and 2016.

Representative Clark Johnson was elected to the Minnesota House of Representatives in 2013 and is currently serving his third term.

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G HEALTH CARE COSTS Wider access to MinnesotaCare

BY EMILY PIPER, JD

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s commissioner of the Minnesota Department of Human Services, I have the privilege of hearing the stories of some of the more than 1 million people we serve. They tell me about their successes and dreams, as well as their needs and frustrations. Over the past several weeks I visited with farmers throughout the state. This is a group that has seen their share of challenges, yet in every community one issue was on the top of their mind: health care.

While Minnesota is known for delivering comprehensive health care options to low-income consumers and coverage has increased dramatically due to the Affordable Care Act, many middle-income Minnesotans shopping for health care in the individual market still lack affordable options.

entirely by the premiums of those who buy MinnesotaCare coverage. This plan would require no additional ongoing costs for Minnesota taxpayers.

The MinnesotaCare buy-in would be a stable, long-term option, reducing uncertainty for Minnesotans and for health care providers, and keeping down the cost of uncompensated care.

5. This is a common sense approach. By building on what we know already works we can fast forward to positive results for Minnesotans. Start-up time could be minimized once the Legislature approves this proposal, giving people a reliable, affordable option in a turbulent health care marketplace.

A MinnesotaCare buy-in won’t solve all health care problems. But it meets an important need and will help 100,000 more Minnesotans get health care they don’t have today. I’d say that’s a good start.

Considering a buy in

Emily Piper, JD, is commissioner of the Minnesota Department of Human

For some, the solution has been MinnesotaCare. This trusted, Minnesotagrown, bipartisan solution has been a lifeline for hundreds of thousands of Minnesotans. One farmer told me that MinnesotaCare allowed both her and her husband to continue working on their farm. Another woman from Greater Minnesota with diabetes said MinnesotaCare allowed her to manage her disease and prevent dangerous complications.

Services, the state’s largest agency. Before joining DHS in 2015, Piper served as general counsel and deputy chief of staff to Governor Mark Dayton and as deputy commissioner and chief of staff for the Minnesota Department of Commerce.

It is experiences like those that prompted Governor Mark Dayton to advance a proposal that would allow more Minnesotans to “buy in” to MinnesotaCare.

Under the plan, anyone who buys their insurance on the individual health insurance market could choose to enroll in MinnesotaCare. As discussion continues about how to best meet the health care needs of Minnesotans, I ask you to consider these five things about a MinnesotaCare buy-in: 1. MinnesotaCare works. For 25 years MinnesotaCare has offered high-quality, lower-cost health coverage for over 100,000 Minnesotans.

Governor Dayton’s proposal would continue MinnesotaCare’s bipartisan success—giving all Minnesotans who purchase their insurance on the individual market the choice to buy into MinnesotaCare, and pay their own way for their coverage.

2. MinnesotaCare provides better access to care. MinnesotaCare provides better access to more doctors. Limited health insurance options in Greater Minnesota make it difficult for some Minnesotans to choose and keep their own doctors. But the broad network of physicians and care providers available through MinnesotaCare would offer more families, all across Minnesota, a real option to choose and keep their own doctors.

3. MinnesotaCare offers greater affordability. People who purchase MinnesotaCare would get high-quality health coverage for approximately $469 per month, on average. That is 12 percent ($69 per month) less than the average statewide premium of $538 for commercial health plans in 2017.

Families would save on average $838 per person, per year on their premiums.

More affordable coverage means Minnesotans are more likely to take care of their health, reducing everyone’s costs in the long run.

4. MinnesotaCare is sustainable and competitive. After a one-time start-up cost of $12 million, the MinnesotaCare buy-in would be funded MINNESOTA PHYSICIAN JUNE 2017

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3A change to Minnesota law from cover

While several attempts have been made to change the HMO licensure requirement over the years, this year the change was attached to a bipartisan premium relief effort for the individual insurance market. With severe encourage these companies to either charge higher premiums or cut back increases in premiums in the individual market over the past several plan on benefit coverage for consumers to satisfy the fiduciary duty owed to years, concern about individual market stability grew for both consumers shareholders. The history of this law and the practical implications of this and companies alike. Without some financial assistance to counteract the change in Minnesota are explored further in this article. losses insurers experienced in covering individuals History needing significant medical care, the individual Minnesota’s HMO licensure statute was market appeared to be in serious jeopardy of originally written to allow only nonprofit losing one or more health insurance carriers for entities to operate as HMOs in the state. This the 2018 plan year. To ensure that a premium Whether an HMO is significant since the state’s public program relief package passed to aid Minnesotans in the is for-profit or nonprofit, laws require that a health plan be licensed as an individual market this year and to keep insurers it must adhere to state and HMO or a county-based purchaser in order to in the market, legislators who might have been federal regulations regarding participate in public programs. With almost 1 otherwise opposed to a change in the HMO benefits and quality of care. million Minnesotans obtaining health coverage licensure law voted for its passage to ensure from Medicaid and MinnesotaCare, insurers premium relief reform was instituted. Separately, have incentives to become licensed as an HMO the Minnesota legislature also passed even more or have an HMO entity in order to participate recent legislation this session to create a statebased reinsurance program to attempt to mitigate in these programs. Additionally, HMOs are the impact of high-risk individuals on rates in the individual market (S.F. still required to participate in Minnesota public health care programs in 720, 90th Leg., Reg. Sess. [Minn.2017]). order to receive and maintain their certificate of authority (Minn. Stat.

62D.04, subd. 5). Therefore, an increase of for-profit HMOs in commercial Implications of the law insurance markets would also result in an increase in HMOs in medical While the change in HMO licensure is a significant deviation from past assistance and MinnesotaCare programs. practice in the state, Minnesota has actually in the recent past been the only state in the country with the requirement of nonprofit status for HMO licensure. Whether this unique approach has been beneficial for Minnesota’s health insurance market is difficult to empirically evaluate. It is challenging to compare other states’ experiences regarding for-profit and nonprofit HMO participation in the individual market, since such a widerange of factors contribute to health care coverage in a given state, or even regions within a state, due to geographic variations in health care cost and delivery. One long-cited benefit of the nonprofit requirement for Minnesota consumers was closer monitoring of the reserves of the insurers operating as nonprofits. Stricter state regulations surrounding reserves potentially holds insurers to stricter standards in terms of balancing insurer profits and consumer coverage. However, both for-profit and nonprofit HMOs need to earn enough revenue to cover the costs of care, which many health plans are currently finding difficult, regardless of for-profit or nonprofit status.

If HMOs currently operating as nonprofits convert to for-profit entities, there is concern that the transaction could result in private inurement and an inappropriate diversion of public benefit assets could occur. In response to this concern, legislation was proposed this session that would require any nonprofit health care entity that wishes to convert to a for-profit entity to obtain approval of the transaction from the attorney general, who would review the transaction in consultation with the commissioner of commerce, and would consider a number of factors to ensure protection of the nonprofit entity’s public benefit assets (H.F. 2334, 90th Leg., Reg. Sess. [Minn.

2017]). The proposed legislation also originally placed significant additional restrictions and requirements on such transactions. However, many of these proposed requirements have since been removed from the proposed legislation, with many legislators arguing the protections in state law already sufficiently protect HMO assets accumulated from public programs. Instead,

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the Minnesota legislation placed a two-year moratorium on currently licensed nonprofit HMOs in the state from converting, consolidating, or transferring a substantial part of its assets to a for-profit entity, until July 1, 2019. (As of the date of this writing, the proposed legislation has not yet been signed into law.)

Lastly, regardless of whether an HMO is for-profit or nonprofit, it must adhere to state and federal regulations regarding benefits and quality of care.

One potential hurdle for new and existing insurers is negotiating provider network reimbursement to fulfill insurance regulatory requirements.

Compared to established HMOs existing in the state, this may be difficult for newcomers, especially among the many larger provider groups in the state. Conversely, if new HMOs enter the market, providers could be presented with an opportunity to forge new relationships with both current and new insurers with increased competition.

These concerns could prove to be unwarranted, since for-profit insurers in other states have decided to leave the individual health insurance market. It is therefore uncertain whether Minnesota will truly experience an increase in competition without further market reforms to address the Some legislators hope high claims experience that Minnesota and other this change will encourage more Stephen Warch, JD, is a shareholder in the states are facing. Additionally, for-profit insurers competition in the Minnesota health care practice group of Nilan Johnson can already sell health insurance in the state of health insurance market.

Lewis, PA, and also serves as president of the firm.

Minnesota, just not as HMOs. For-profit insurers Steve is a former Deputy General Counsel with can obtain licensure in Minnesota as preferred provider organizations (PPOs), and a number UnitedHealthcare, and a former Assistant Attorney of companies have such licensure in Minnesota.

General with the State of Minnesota.

While a different set of laws apply to PPOs and HMOs in Minnesota, the distinction is largely a Lindsay McLaughlin, JD, MPH, is a health care attorney with Nilan Johnson formality rather than actually significant in practice due to the changes in Lewis, PA. Her practiceâ&#x20AC;&#x201D;rooted in her background as the Health Policy the health care regulatory landscape over time. Significantly, the Affordable Advisor for the Minnesota Department of Commerceâ&#x20AC;&#x201D;focuses on regulatory Care Act standardized much of the insurance industryâ&#x20AC;&#x2122;s rules, such as and compliance work for a variety of health care entities, including health care required benefits and actuarial value levels, making the differences between HMOs and PPOs nominal. systems and health insurers.

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MEDICAL FACILITY DESIGN

Shedding new light on health care Rethinking lighting design

BY RENALDO PESSON, NCIDQ, IIDA, AAIA

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he evolution of medicine has been based on evidence and research, and this is true when it comes to health care facility design as well. In the past decade, the use of evidence-based design (EBD) by those who design health care facilities has grown. The Center for Health Design defines EBD as, “the process of basing decisions about the built environment on credible research to achieve the best possible outcomes.” The physical environment impacts the lives of patients, staff, and visitors and as such, one of the leading concepts for EBD is to “do no harm.” Originally, EBD principles focused purely on the patient. Today architects know that it’s critical to design for both patients and providers. By considering the health and well-being of providers, it enables them to give better patient care. A new study by patient safety researchers shows that medical error may be the third leading cause of death in the U.S. after heart disease and cancer (Washington Post article

by Ariana Eunjung Cha, May 3, 2016). As a result, the design industry has course-corrected with the objective to “do more good.” Each time the design team approaches new construction or a renovation project they must consider how design can help keep providers healthy and positioned to provide the best possible care for the one most in need, the patient.

Today, architects and designers work closely with medical staff, facility managers, and other key stakeholders to provide optimum health care and better performing facilities through design.

Basic lighting design One design element that plays an important role in supporting both patients and providers is lighting. In the past, lighting was typically dictated by the engineer and considered a wayfinding tool, not a design

Figure 1. In the atrium, preset LED illumination replicates afternoon sunlight and the evening Aurora Borealis. Lowered evening light levels synchronize circadian rhythms inducing a sense of calm.

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element. The engineer would simply install a light fixture based on desired or calculated light levels. The design of lighting fixtures was sometimes left to the architect, or an artist, but the role of “lighting designer” was yet to be defined. When lighting options expanded from incandescent bulbs to fluorescent, new fixture types helped give rise to the field of lighting design.

Researchers longed for even more efficient light sources than the fluorescent bulb. LEDs (light emitting diodes) resulted from a quest for lighting with more versatility, durability, and with a smaller energy signature. With LED, the evolution of the field of lighting design really took off. LEDs do not burn out or fail; they fade over a period of years. This depreciation of lumen output, of the remaining percentage of the LED life, is not discernable to most observers and the unit may continue its light output with color shifts until replacement. Because of its technology, LED is continually being adapted to countless scenarios and configurations allowing opportunities to do more with illumination.

Use of lighting in health care facilities Architects who focus exclusively on designing health care facilities understand that it is important to create a holistic environment that considers all the senses. Through smart facility design (a philosophy and practice that reduces operating costs, supports new care models, energizes staff, provides flexibility, and promotes wellness) it is possible to create a restorative environment that promotes health for providers and patients alike. Another key element in today’s planning best practices, is to design to accommodate technological advances as they come online. Some in the industry challenge whether color, sound, and even scent can make for a better patient experience, but there is consensus through research that lighting influences most elements of our lives (article by Anjali Joseph for The Center for Health Design, August 2006.) The circadian system is responsible for

Figure 2. The oculus within the nurses’ station can be controlled to match sun passage, heighten alertness, or simulate movement for visual stimulation.

and Dawson (1992) have reported, the two most common and destructive problems associated with shiftwork are reduced quality of sleep following night work and reduced capacity to maintain alertness while at work. Thus, shift work has drawbacks in increased accidents, decreased production, and performance deficits among those who are working at night when the body has a natural tendency to be asleep. Furthermore, evidence indicates that shift workers have increased health problems such as cognitive and emotional issues (Moore-Ede et al., 1982; U.S. Congress, 1991). Lighting There are some hospitals that still take a simplistic view of lighting design today also incorporates the concept that and think of it as fixtures only or just another lighting systems can vary depending on what part component of the HVAC system contributing of the facility they are in to best suit the purpose to people’s basic comfort levels. Sometimes of that specific area. Technology facilitates more facility managers ask how LEDs might work in user-centric design in spaces where architects downlights, 2x2, or 2x4 fixtures, or in a sconce can consider lighting zones, and design to serve Lighting influences most but rarely ask how lighting can be thoughtfully a specific function or a series of activities (see elements of our lives. planned and designed. In the past, this limited Figure 2). There are increased lighting scenarios way of thinking prevented the advancement of and potential illumination events to create and lighting design. Fortunately, in the new age of consider now with endless possibilities in the LED products, there’s an opportunity to create near future as LED research and development significant lighting impact and enhance the health continues to grow. care workplace and this is starting to happen.

For example, LED lighting can be Supporting providers programmed for certain effects in provider work areas to achieve maximum Doctors and nurses spend a significant portion of their time inside a facility, awareness and reduce the potential for medical errors. Research and evidence often working 12-hour shifts or longer without any access to daylight or support the theory of lighting levels and quality impacting the performance the outside environment. LED offers the opportunity to counteract the of individuals where attention is paramount. One European study by negative health impact of too little daylight by controlling the cycling of ARUP Global Research found that error rates in prescription dispensing indoor illumination. Programmed LED lighting systems can replicate the significantly decreased when daylighting was optimized. LED may help sun’s natural progression throughout the day. For example, the lighting in providers maintain focus through color temperature programming, to a nursing zone can be scheduled to mimic daylight starting with a bright simulate daylighting. Several studies cover the attention span and alertness of warm morning glow, then to bright 5,000 Kelvin (a unit to measure the color workers under various lighting levels (brightness) and lighting temperatures of a light source, referred to as temperature, where the higher the number (Kelvin). LED can be programmed to fluctuate from the more amber color the closer to sunlight) like the afternoon sun, and back down to the warm to a whiter light (see Figure 3). According to a 2013 study published in glow of the setting sun. Using lower light temperatures of 2,000 Kelvin (not The Journal of Neuroscience, blue lights can depress night workers, while necessarily light brightness levels) in provider respite rooms reduces anxiety and fatigue, while inducing a sense of calm for those on break. As Campbell Shedding new light on health care to page 464 controlling daily rhythms such as sleep and wakefulness, body temperature, hormonal secretion, and other physiological parameters including cognitive function. Light is the primary stimulus for regulating the circadian system, although other external stimuli such as sound, temperature, and social cues may also influence the body’s timing functions (Aschoff, 1981a; Binkley, 1990), and as such is a controlling factor for achieving a more restful and relaxing environment (see Figure 1).

Figure 3. The illusion of gentle rolling clouds across an artificial sky is a pleasant distraction in a high-stress setting like an imaging room.

Figure 4. Programmed LED settings replicate the circadian rhythms of rise, awake, and decompress for sleep. In Pediatrics, accent wall color can be illuminated in the patient’s preference without a paint change.

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MEDICAL FACILITY DESIGN

Building new health care facilities How to plan for a successful project

BY RICHARD P. ENGAN, AIA, LEED AP, CID, AND MITRA MILANI ENGAN

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our building project may be one of the largest investments you ever make. All building project team members—including project owners and their architectural team—need to work carefully with the budgets they are entrusted with, and design decisions need to return benefits immediately and into the long run. Moreover, architectural decisions often have to include the needs of multiple stakeholders. The project-planning phase is the optimal opportunity for you to achieve the facility of your dreams, benefitting you for years to come.

So what’s the best way to start a project? Whether you have a lot of experience or none, it’s best to start by asking yourself some key questions.

Your answers to these questions don’t need to be completely fleshed out right away. The purpose of thinking about them is to orient yourself to the kinds of communication that will help you choose the best design professional for your needs.

Questions to ask 1. Why do you want to do this project—what outcomes do you need?

Common health care needs include: production increases (the volume of work in a facility); quality improvements; staff retention; customer satisfaction improvements; and technology updates.

2. What is your greatest hope for the project? Examples include: minimal disruption in daily operations; the budget is maintained until project completion; staff is satisfied with the end product; customers like the facility; and current and future technology has been accommodated.

3. What is your greatest fear when it comes to the project? Health care leaders are often concerned that a project may prohibit or interrupt delivery of services, include mandatory cost adds during the project, deliver an end product that’s unsatisfactory for staff or customers, or neglect to take current or future technology needs into account.

4. How will the core decisions for your project be made? Will it be just you, a board of directors, or other stakeholders? Some organizations use very formal decision-making structures, while others choose more fluid processes. Related questions include: Is having a meeting with a broad group of stakeholders the best place to start the planning process? Are small meetings of select groups of people ideal? Is input from upper management the best way to begin?

5. Where will the resources for the project come from? It’s important to consider the source(s) and security of financing for a project. Has a feasibility study been done?

6. When do you need your project to begin and end? Time management needs vary from project to project. For example, a project’s most important variable can be: 1) the shortest time and least disruption to operations during the project; 2) the shortest time and least disruption to operations for specific parts of the project; 3) limits on disruptions, e.g., noise, specific periods where work cannot be accomplished, etc.

A related consideration is the option of liquidated damages, where money is paid by a general contractor (GC) to an owner when a project is not completed on a pre-determined schedule. In our experience, if liquidated damages are required it’s advantageous for a project owner to also consider using time-related bonuses to incentivize a GC to complete a project ahead of schedule. Construction teams respond more positively when there is the opportunity for bonuses as well as damages. The end result is a more efficient construction project, providing a fully-functioning facility with minimal disruption.

7. How long do you anticipate using the facility? Do you want this facility to last for the long-term or are you expecting to make changes a few years down the road?

8. Is it important for the building to be easily modified for necessary changes in the future? What types of flexibility are required? Spaces can be planned generally so people can be moved to new work locations with no or minimal construction. Spaces can be planned for multiple uses. Building

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systems (HVAC, mechanical, electrical, IT, etc.) can be planned so that layouts can be modified easily.

These answers—and the thought process they stimulate—help you and your architect develop a shared vision for your project. These questions also serve as the basis for the predesign services and a roadmap for the success of your project.

The importance of listening While each architectural team has unique strengths, there are a couple of qualities that are universally important.

1. Listening: A building project is a collaboration and a successful collaboration begins with listening. You are the expert when it comes to understanding your needs. Your architect should listen to you first, then advise you on creative design solutions to meet your needs.

and consultants needed to meet your specific needs. Your architect will be sure they understand and share the project vision. At this critical stage of your project, it is especially important that your architect is skilled at listening, communicating, and bringing ideas to the table.

During the schematic design phase your architect will use the information gathered so far to bring efficiency, environmental responsibility, and creativity to your project. During this phase, some or all of these things are accomplished: • Create a schematic design • Establish an image for the building Building new health care facilities to page 384

2. Value: Through active listening, your architect should understand what is most valuable to you. The result is a project that meets your objectives in quality, cost, and efficiency.

Launching your project Projects typically begin by considering the big picture, then working toward the details. These are the standard stages that projects are typically organized into: 1) predesign; 2) schematic design; 3) design development; 4) construction documents; 5) bidding and negotiating; 6) construction administration; and 7) post occupancy.

Based on the shared vision developed in your first conversations, your architect will assemble a core team uniquely qualified to meet your needs.

The team includes you (the client), a project manager, a designer, and a construction administrator. Depending on the nature of the project, a group of technical specialists may also benefit the project such as structural engineers, mechanical engineers, electrical engineers, civil engineers, acoustical engineers, or lighting designers.

Predesign During the first phase—predesign—your architect will identify opportunities to fulfill your project goals through some or all of the following steps: • Review the needs and mission of the project • Complete a needs study • Select a site • Analyze the site • Do an existing building condition survey • Do an historic building survey • Discuss and establish options • Do a preliminary building code review • Do a preliminary cost summary • Discuss and establish a time frame for the project The outcome of this process is a vision for your project that is shared by all members of the team. This vision will include answers to the eight questions outlined at the beginning of this article.

Schematic design With predesign complete, the team now expands to include engineers

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MEDICAL FACILITY DESIGN

Antimicrobial materials in health care facilities Creating more harm than good?

BY SANDRA J. CHRISTIE, AIA, LEED AP BD+C

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inishes and materials used in building projects increasingly include antimicrobial additives. Paints, countertops, fabrics, and a host of other touchable materials used in buildings are now treated to have antimicrobial properties. At first glance, this would appear to be a good thing for health care settings, but is it really?

Antimicrobials come in many forms but essentially they all act as pesticides. By definition and design, they are toxic to certain organisms: bacteria, viruses, fungi, or protozoa—collectively known as microbes.

Microbes are commonly associated, by the general public, with illnesses such as the flu virus or more serious bacteria including drug-resistant staphylococcus (MRSA). However, not all microbes are bad. The microorganisms in our gut are vital to our health. With the addition of antimicrobials in our building materials and finishes, it is beneficial to understand what exactly they are contributing, or not, to our health and environments.

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Why are they being marketed?

Hospital-acquired infections (HAIs) such as MRSA, urinary tract infections, and pneumonia are a growing concern. Treating patients with HAIs is expensive (estimated at $33 billion in 2009) and more routinely, hospitals are not being reimbursed for this care. Medicare pressures make the need for improved infection control practices increasingly important.

The Centers for Medicare & Medicaid Services has a public website that publishes each facility’s HAI data. Along with fears of potential lawsuits, these policy changes have created a reason for manufacturers to target hospitals and clinics with new antimicrobial products.

Here are just a few of the additive products marketed in antimicrobial products: • Elemental silver/silver nanoparticles: Found in upholstery, fabrics, hardware, ceramic tile, countertops, paints, and carpets.

• QACs (Quaternary Ammonia Compounds): Found in disinfecting products, wood products, and specialty paints.

• Triclosan: Found in textiles, plastic parts, hardware, ceramic tile, countertops, carpet, and soaps and cleaning products.

Typical marketing language touts “peace of mind” in “areas where vigilance in the war against [microbes] is critical.” In one example, product literature for antimicrobial light switches promotes independent laboratory testing that shows the additive is effective against bacteria such as the drug-resistant strain of staphylococcus commonly referred to as MRSA. However, it only briefly confirms elsewhere, in smaller text, that the antimicrobial additive is present only as a preservative to protect the switch and cover from mold, mildew, and other microbes that may jeopardize the “integrity of the product,” not to prevent the spread of MRSA which it had previously implied.

A May 2014 study found that triclosan actually promotes the growth of staph infections. Researchers have found strains of E. coli with varying resistance to both triclosan and to new antibiotics being tested to combat them. Quaternary ammonia compounds (QACs) used in many cleaning agents have also been shown in laboratory tests to “lead to the emergence of antibiotic-resistant bacteria and may represent a public health risk.”

Antimicrobial materials in health care facilities to page 444

What is the evidence?

While some manufacturers for building products may have testing to show that antimicrobials eliminate various microbes on the material’s surfaces, there is no corresponding evidence that infection rates in health care environments are decreased as a result of their use. In 2003, the Centers for Disease Control and Prevention (CDC) reviewed the use of products with antimicrobial additives for their Guidelines for Environmental Infection Control in Health-Care Facilities. They concluded that, “no evidence is available to suggest that use of [products impregnated with antimicrobial additives] will make consumers and patients healthier or prevent disease.

No data supports the use of these items as part of a sound infection-control strategy.” The CDC recommends that health care providers are better off concentrating on proper cleaning practices and maintaining their heating, ventilation, and air conditioning (HVAC) systems.

In 2016, the Food and Drug Administration (FDA) completed an extensive review of data on the efficacy of antimicrobial additives in hand soaps. They determined that manufacturers have failed to show any evidence that these additives provide a benefit to human health. Based on that study, they have banned triclosan and 18 other chemicals in all hand soaps because of the negative effect on human hormones and health.

The CDC and FDA don’t regulate building products; this is done by the Environmental Protection Agency (EPA). The EPA takes unsubstantiated health claims very seriously. In a 1998 bulletin responding to the use of products with antimicrobial additives, they warned: “EPA is concerned about these statements because, in addition to being unlawful, they are also potentially harmful to the public—if people believe that the product has a self-sanitizing quality, they may not practice standard hygiene to prevent the transmission of harmful germs. Consequently public health may be less protected. For that reason, EPA advises consumers not to rely on antibacterial claims as a substitute for following common-sense hygienic practices. EPA does not know whether these treated products work as claimed.”

Increased risk of superbugs The widespread use of antimicrobials may be contributing to the emergence of microbes resistant to them. Antimicrobial resistance occurs when an antimicrobial agent is applied to a microbial population, but does not kill all of the organisms. Surviving organisms develop an immunity to the antimicrobial and pass along this immunity as they reproduce. Even more concerning, the evolving microbes may be resistant to therapeutic antibiotics used by health care providers.

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2017 health care architecture

HEALTH CARE ARCHITECTURE

HONOR ROLL

University of North Dakota School of Medicine and Health Sciences Type of facility: Medical school Location: Grand Forks, ND Client: University of North Dakota Architect/Interior design: JLG Architects; Perkins+Will; Steinberg Architects Engineer: Heyer Engineering; Obermiller Nelson Engineering Contractor: PCL Construction; Community Contractors Completion date: May 2016 Total cost: $124 million Square feet: 318,000

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he fact that there wonâ&#x20AC;&#x2122;t be enough doctors in North Dakota to serve the growing population brought together state legislators, city leaders, health care educators, and design and construction professionals to change the future of health care delivery. And so the Healthcare Workforce Initiative was born and the linchpin in training more practitioners, the University of North Dakota School of Medicine and Health Sciences (UND SMHS), was built. The building balances education, research, and service. Large outside windows and inner transom windows let natural

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light spill into the interior spaces. Flexibility was important so the building can move into the future with minimal modification. A grand staircase, that includes seating, accommodates the movement of large groups and lounge areas throughout the building encourage discussion and collaboration. Designing open labs and offices that are grouped together promotes inter-professional teamwork. The largest public project in North Dakota history, UND SMHS is an interdisciplinary learning environment that readapts a health sciences curriculum and methodologies for generations to come.

Minnesota Physicianâ&#x20AC;&#x2122;s 2017 Health Care Architecture Honor Roll recognizes 11 outstanding projects. This yearâ&#x20AC;&#x2122;s Honor Roll includes new or renovated clinics, a medical school, a hospital entrance, senior housing, and a surgical suite in urban, suburban, Greater Minnesota, and North Dakota.

Minnesota Physician Publishing thanks all those who participated in the 2017 Honor Roll.

We received a lot of impressive nominations!

By Lisa McGowan

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HEALTH CARE ARCHITECTURE

HealthPartners Dental Specialty Center Type of facility: Multi-specialty dental clinic Location: Lake Elmo Client: HealthPartners Architect/Interior design: Mohagen Hansen Architecture | Interiors Contractor: Greiner Construction Completion date: January 2017 Total cost: $999,000 Square feet: 7,600

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he d e s i g n s olut ion s a t t he ne w HealthPartners Dental Specialty Center in Lake Elmo meet the needs of multiple oral care specialties including general dentistry, pediatric dentistry, oral surgery, orthodontics, periodontics, prosthodontics, and endodontics under one roof. The new clinic incorporates HealthPartnersâ&#x20AC;&#x2122; branding and clinic design standards. A warm, uplifting color palette mixed with soothing textures, and nature

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photography were used to ensure that patients feel comfortable when visiting the clinic, whether they come in for a regular cleaning or oral surgery. Warm wood tones and natural lighting gives the environment a calm, natural feel, while maintaining functionality and improving the efficiency of the space. The clinic includes 11 exam rooms, four oral surgery rooms, a consult room, treatment bays, a tooth brushing station, and other laboratory-based areas.

HONOR ROLL 2017

Aurora on France Vibrant Senior Living and Care Type of facility: Senior living Location: Edina Client: Aurora Investments, LLC Architect/Interior design: Pope Architects; Encompass Interiors Contractor: Adolfson & Peterson Construction Completion date: December 2016 Total Cost: Withheld Square feet: 278,583

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ocated in the heart of Edina and connected to Fairview Southdale Hospital via an enclosed walkway, Aurora on France offers senior apartment homes, assisted living, memory care, care suites, and transitional care all within one beautiful community. Aurora is very innovative in terms of its design, its location, products and services, and business structure. It is well positioned to help reduce hospitalizations or return visits to the hospital, improving patient

outcomes, and reducing the overall cost of care.

The facility features a classic contemporary style with amenities including a library and outdoor patio both with fireplaces, bistro, clubroom, community room, theater, restaurant style dining, hair salon, spa, fitness center, private dining, childrenâ&#x20AC;&#x2122;s play nook, and heated, underground parking. The transitional care unit also offers a rehab gym and space for physical, speech, and occupational therapy.

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HEALTH CARE ARCHITECTURE

Ridgewood Villa Senior Living Apartments Type of facility: Senior living Location: Glenwood Client: Glacial Ridge Health System Architect/Interior design: EAPC Architects Engineers Engineer: EAPC Architects Engineers (structural, mechanical, electrical); Widseth Smith Nolting (civil); Ohlson Lavoie Collaborative (aquatics design specialist) Contractor: McGough Construction Completion date: August 2016 Total cost: $8,241,714 Square feet: 42,286 addition; 3,420 remodel; 6,656 garage addition

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his independent living campus in Glenwood offers seniors the freedom to truly live independently, while providing many of the comforts of home and opportunities to gather with friends.

It’s a home built for seniors 55+ and it was designed to meet their changing needs.

“The Villa” expansion more than doubled in size with 30 new living units, a welcoming commons area, and a state-of-the-art wellness

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center with a warm water exercise pool.

Additional amenities include a full service retail pharmacy and gift shop, a beautiful fireside lounge, informal activity lounge, beauty and barber shop, laundry on each floor, formal dining room with a patio, craft room, chapel, library, new vehicle drop off/ entry, 24-hour secured entrances, heated/ attached parking garage, elevator service, and secure indoor mailboxes.

HONOR ROLL 2017

Allina Health, United Hospital Hybrid OR Type of facility: Foley Hybrid surgical suite Location: St. Paul Client: Allina Health Architect/Interior design: EAPC Architects Engineers Engineer: EAPC Architects Engineers Contractor: McGough Construction; Nasseff Mechanical Contractors; NEI Electric Completion date: March 2017 Total cost: $1.5 million Square feet: 2,689

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nterventions in surgery and interventional radiology have different requirements when it comes to the flexibility of an angiography system. United Hospitalâ&#x20AC;&#x2122;s new 865 SF Foley Hybrid OR in the Nasseff Heart Center offers the best state-of-the-art in heart care. The new surgical suite blends the capabilities of a cardiovascular catheterization laboratory, where minimally invasive heart procedures are performed, with a traditional surgical suite where open-heart

surgeries occur. The Hybrid OR, which is large enough for a dozen clinicians to work seamlessly, features the latest in robotic three-dimensional imaging. With real-time image guided surgical and advanced interventional procedures the Siemens Artis Zeego robotic C-arm in this new operating room increases procedural efficiency by providing uninterrupted, unstructured access to the patientâ&#x20AC;&#x2122;s targeted area with full flexibility to patient positioning.

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HEALTH CARE ARCHITECTURE

Catholic Eldercare TCU Type of facility: Transitional care unit Location: Northeast Minneapolis Client: Catholic Eldercare Architect/Interior design: Pope Architects Contractor: Frana Companies Completion date: October 2016 Total cost: Withheld Square feet: 40,000

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ocated in the heart of Northeast Minneapolis, Catholic Eldercare has a new three-story, 24-bed transitional care unit that offers patients recovering from surgery, injury, or stroke a place to heal while still maintaining their independence.

Pope Architects helped plan and design the expansion and remodel of the existing campus, creating a calming environment to help speed healing. A new on-site adult day space is a

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vibrant, relaxing space for seniors needing weekday support. The expansion supports rehabilitation services including physical, occupational, and speech therapy rooms that are filled with natural light. Guests can enjoy an outdoor park-like green space, bistro dining, a beauty salon, and chapel. The large TCU rooms include a kitchenette and private bathroom and four rooms have a lift system for less mobile or disabled guests.

HONOR ROLL 2017

Miller Creek Medical Clinic Type of facility: Primary care clinic Location: Hermantown Client: St. Luke’s Architect/Interior design: DSGW Engineer: Northland Engineering Contractor: Donald Holm Construction Completion date: December 2016 Total cost: $6.5 million Square feet: 20,000

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rom the outside, the Miller Creek Medical Clinic looks more like a northern Minnesota lodge than a medical facility. It was important that the clinic reflect the community’s Northwood’s character. A post and beam entry canopy protects patients from the weather when being dropped at the door. Inside, the waiting room and registration area are spacious and provide a great deal of privacy for patients. The clinic

has lots of windows that let the outdoors inside with lots of natural light, which provides a calming, healing environment. The large, open physical rehabilitation gym is also flooded with light and offers views outside the large windows. The interior layout embraces LEAN efficiencies and offers a better flow through the clinic for patients and a more efficient flow for staff, which makes it a first class facility for both.

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HEALTH CARE ARCHITECTURE

Summit Orthopedics Eagan Type of facility: Clinic and ambulatory surgery center with care suites Location: Eagan Client: Summit Orthopedics Architect/Interior design: Pope Architects Engineer: Pope Architects (interior TI); Welsh Architecture (core & shell); Gilbert Mechanical (HVAC & plumbing); Hunt Electric (electrical); Innovative Structural Solutions, PA (structural); Civil Site Group (civil) Contractor: RJM Construction Completion date: March 2017 Total cost: Withheld Square feet: 74,420 (+24,040 underground parking)

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f fering the full continuum of orthopedic care and treatment, Summit Orthopedics opened a new innovative outpatient facility in Eagan. The care suites provide a comfortable place to recover in hotel-style rooms with luxurious finishes. Natural materials, expansive daylighting, and a refined color palette create a welcoming and restorative environment for patients and staff. Sustainable, recycled, and low-emitting materials were

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used throughout the project. Efficient lighting solutions were incorporated into the design and feature LED lighting and sensor lighting controls.

The first floor includes a clinic, retail space, and a discrete rear exit for surgery patients. Physical therapy, along with procedure and bracing services, are conveniently placed next to the care suites on the second floor. The surgery center, which has five operating rooms, is on the third floor and offers privacy and dignity for patients.

HONOR ROLL 2017

North Loop Clinic and Pharmacy Type of facility: Outpatient clinic Location: Minneapolis Client: Hennepin County Medical Center Architect/Interior design: HGA Architects and Engineers Contractor: JE Dunn Construction Completion date: April 2017 Total cost: Withheld Square feet: 6,312

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he new North Loop Clinic and Pharmacy fits seamlessly into the historic TractorWorks Building in the vibrant and eclectic North Loop neighborhood. Modern design elements throughout the clinic blend with the rich history of the buildingâ&#x20AC;&#x201D;where John Deere tractors were once manufactured.

The lobby and waiting room feature original exposed brick and structural pillars that have been incorporated into the design to

provide warmth and authenticity. Uplighting surrounding the pillars and a natural wood wall behind the front desk adds to the contemporary feel. Locally sourced materials were utilized when possible. The 10 exam rooms provide bright colors, ample space, and modern floor coverings to set patients at ease with their clinic experience. The clinical Team Center workspace offers an interdisciplinary collaboration area for the clinical staff and easy access to exam rooms.

Hello Progress Advancing health and wellness in local communities is at the heart of our endeavors.

612.524.6000 hdrinc.com

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HEALTH CARE ARCHITECTURE

Rice Rehabilitation Center Type of facility: Outpatient physical rehabilitation Location: Willmar Client: Rice Memorial Hospital Architect/Interior design: Perkins+Will Engineer: Dunham Associates; Meyer Borgman Johnson; and Bolton & Menk Contractor: Marcus Construction Completion date: July 2016 Total cost: $5.1 million Square feet: 11,000 first floor and 5,500 lower level

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he new Rice Memorial Hospital Rehabilitation Center offers separate adult and pediatric treatment gyms that provide a collaborative rehab therapy environment as well as an outdoor pediatric treatment playground. The building also features a warm water therapy pool with a selfcontained underwater treadmill that can be raised and lowered to accommodate the needs of each patient. Daylight was an important design driver in

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this project. Treatment rooms have windows that are above the line of sight to provide daylight while respecting patient privacy. Transom windows in the corridor maximize daylight reaching the interior spaces. The building utilizes full height windows in the adult gym and waiting area to create bright, open environments. The buildingâ&#x20AC;&#x2122;s structural and mechanical systems are designed for vertical expansion. The exterior skin is composed of fiber cement panels using rain screen installation methods.

HONOR ROLL 2017

St. Francis Regional Medical Center Type of facility: Grand entrance and lobby Location: Shakopee Client: St. Francis Regional Medical Center Architect/Interior design: BWBR Architects; Allina Facilities Project Management Engineer: Dunham Contractor: D.J. Kranz, Co., Inc. Completion date: October 2016 Total cost: $7 million Square feet: 5,500

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he dramatic new main entrance and lobby at St. Francis Regional Medical Center was designed to be a prominent, visual entry point for guests and to provide easy access to the hospital, clinics, and new retail areas. The two-story entry has a vaulted glass faรงade that brings in natural healing light. Interior LED ambient lighting, soft seating and lounging areas, Terrazzo flooring, a color-changing fireplace, and a guest welcome center reduces stress and creates

a positive first impression. A wide concourse leads visitors to the medical retail area that includes a pharmacy and other stores and has the feel of a mall. The grounds leading to the entrance have a snowmelt system for the winter months and feature colorful plantings for an organic feel.

Careful attention was paid to exterior lights to reduce light pollution by using LEDs that point downward.

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3Building new health care facilities from page 23 • Resolve function needs • Consider sustainability • Consider the effect on the site • Consider the effect on the community • Establish electrical and mechanical systems • Designate furniture and equipment • Comply with building codes • Consider land use • Generate construction documents, plans, and specifications.

This phase should produce your project’s design and establish the quality expected for the project.

Design development In this stage of your project, your architect will develop the schematic design into a complete design that includes drawings and written descriptions.

Some specific items for project owners to consider during design development:

construction management, or integrated building delivery (IBD is a collaborative construction management process that brings contractors into the process earlier than other methods).

Bidding and negotiating, and construction administration During these final two phases of the construction process, an architect typically provides these services: • Acquires approvals from regulatory agencies • Manages the bidding and negotiating processes • Conducts and documents pre-construction meetings • Assists building inspectors, fire marshal, etc.

Health care projects have unique priorities during construction because the industry requires higher standards for things such as infection control.

It is a particular challenge to keep a health care facility in business during

Architectural decisions often have to include the needs of multiple stakeholders.

• Is there a good understanding of the effects this project will have on your operations?

• In this stage the building systems are being firmed up. It’s important to have the best estimation of the project cost while there is still time to make changes. It is important to have a sense of non-hard construction costs like furnishings and equipment.

• Preliminary review with approval agencies can be very important if there are gray areas.

Construction documents In the construction documents phase, the team expands to include building contractors, trade contractors, and material suppliers. The work of this phase provides the basis for your project’s construction contract.

Architectural plans are used to write the technical specifications including mechanical, electrical, and HVAC components, as well as medical equipment and furnishings. Your project manager will review submitted products and drawings, conduct team meetings, and field questions.

Here are some items for an owner to be aware of during the construction documents phase: • Is there space to accommodate the next generation of equipment?

• Do you have staff that can operate the proposed building systems?

If not, will the vendors provide the required training? At this stage, they are usually willing to make the sale.

• Does the phasing plan allow you to stay in business with reasonable precautions?

• Are infection control procedures in place? Do you have a plan to meet your infection control obligations? Are the infection control requirements for the contractor clearly specified and understood?

This phase is also the time for decisions to be made about how best to procure construction services. Options include a general contractor,

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renovation projects. Effective phasing plans should cover the major construction items and work such as sewer, phone, or electrical can often be treated like mini projects. Project contractors must be sure that a facility’s life safety features remain operational during the project. Exits need to be clear and labeled, a construction fire barrier must be maintained, and fire alarm and sprinkling systems have to be operational. The construction phases are a very good time for facility staff to learn about the new building systems. Staff should be included in any closeout training at the end of the project.

Post-occupancy An architect’s goal is to have happy clients. During this phase, your architect should carefully monitor the success of your project by considering the following: 1) requesting input from you on the success of the project; 2) conducting meetings required to resolve incomplete tasks; 3) conducting meetings required to resolve warranty issues; and 4) issuing a certificate for final payment.

While each client and project are unique, the questions in this article can really help health care leaders start a project with confidence. With successful planning, owners can realize their dreams for facilities that succeed now and for years to come.

Richard P. Engan, AIA, LEED AP, CID, is principal architect and founding partner of Engan Associates Architects and Interior Designers. Founded in 1979, Engan Associates specializes in critical access health care design.

Mitra Milani Engan is the communications director at Engan Associates Architects and Interior Designers.

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MEDICINE AND THE LAW

One year after Prince’s death Time for increased accountability

BY CHRIS JOHNSON, MD, AND SENATOR CHRIS EATON, RN

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pril 21, 2016 will forever be a sad day in the cultural memory of Americans in general and Minnesotans in particular— the day that Prince died. His death was a tragic event for those closest to him and for the rest of us who were moved by his musical creativity and genius. His passing was a loss that truly reverberated around the world. It was a death made all the more tragic because of its manner—overdose. However, the death of Prince was merely the most public episode of a crisis that has claimed the lives of over 200,000 Americans in the last 16 years—the prescription opioid and heroin epidemic. Patients with faces known only to their friends and family have passed in a similar manner to Prince—years of doctor-prescribed opioids that led to dependence, addiction, and overdose by either pill or illicit opiates such as heroin. So far, the medical profession and pharmaceutical industry has done little to stop it and, in some instances, behaved in ways very much at odds with the admonitions of the Hippocratic Oath. For this reason, the legislature needs to partner with medicine to take bold steps to rein in this epidemic.

Troubling realities Recently, documents were unsealed that reveal some very troubling realities about Prince’s death. One fact in particular that shocked all of us was the revelation that one of his physicians prescribed oxycodone for Prince in the name of his drummer—Kirk Johnson. This was done supposedly to protect Prince’s privacy, which makes no sense. Patient privacy is already protected and the doctor/patient relationship is one of the few granted special privileged status under the law. Yet that was not the worst of it. Even more shocking was that we learned that one of the oxycodone prescriptions was written the very same day Prince’s plane dove out of the sky for lifesaving Narcan. So, Prince had an immediately life threatening overdose and was prescribed more of the same compound that almost killed him. By a physician. Within hours.

Before we cast stones at Prince’s physician, however, it is important to note that we have evidence that writing prescriptions for opioids for people demonstrating risk for adverse outcomes is something that is happening all over this country, every day. In the December 2015 issue of the Annals of Internal Medicine, researchers in the Boston area studied almost 3,000 patients who were treated in the emergency department or admitted to the hospital for opioid overdose. In 90 percent of those patients, they were back on prescribed opioids in less than two months, and in 70 percent of those patients, it was from the same physician that prescribed the opioids before the overdose. There is no other way to put this—physicians are actively putting patients’ lives at risk. This is a betrayal of the trust that patients place in the medical profession. Some have speculated that maybe those physicians were unaware that their patients experienced an overdose, but that stretches the boundaries of believability. That would mean that somehow in the era of electronic records, the Boston area amassed the most grossly negligent doctors in the country. The reason those doctors still prescribe opioids to those patients who have demonstrated high-risk behavior related to those opioids is simple—the patient demands it, and our business model demands we have happy customers who will come back again.

Stopping the epidemic So far, the loudest noises about what to do about the epidemic have focused on treatment—increased access to Narcan for those acutely overdosing and increased access to medication-assisted therapy (MAT), for those demonstrating symptoms of opioid use disorder (OUD). We support such efforts. But patients can lose their jobs, homes, and important relationships well before they have gotten to the stage of needing such remedies. To truly reverse this crisis, we need to focus increased attention on prevention.

Prevention means physicians must stop initiating these medicines for patients with most chronic pain conditions and by dramatically reducing the size of prescriptions for pain from acute injury. The studies out of Dartmouth published in the Annals of Surgery March 2017 demonstrated that with specific education and controls, the number of pills taken by patients after surgery can be cut by more than half. Such exposure reductions are critical because other recent studies have shown that patients can become dependent or addicted astonishingly fast. The Kaiser Family Foundation

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report released in December 2016 showed that a full 34 percent of patients and Senate in the 2017 session and Governor Mark Dayton has included taking opioids for just two months reported they were dependent or addicted. it in his budget. The bill would require pharmaceutical manufacturers who Such data demonstrate how crucial it is to avoid starting patients on these sell opioids in Minnesota to add to their licensure fee—$.01 per morphine medications because in the time it takes to come back for a three-month milligram equivalent on any opioid shipments into Minnesota. The Board follow-up visit, the damage might already be done. The critical importance of Pharmacy will calculate the amount owed each March from the previous of preventing opioid use disorder from ever years’ sales. The money is to be used to develop occurring was underscored in the April issue of and administer opioid education, prevention, the Journal of Addiction Medicine where a large and treatment. Legislation was also proposed to study demonstrated that almost 1 in 5 patients require 10 hours of pain management/medication with OUD were dead within nine years. This education for all medical students and practicing Patients can become dependent corresponds to a yearly mortality rate roughly 10 prescribers. One bill restricts the validity of or addicted astonishingly fast. times that of the unaffected population. a prescription to 30 days; another requires a prescriber to check the PMP when prescribing unless the patient has a terminal disease. Not Legislative response all of the provisions passed, but increased action To those who think that lawmakers should remain on the part of lawmakers to address an issue out of what is essentially an issue for medicine to that medicine is not solving is becoming more solve, it should be pointed out the Legislature has already gotten involved common in this country. Similar proposals are being introduced in states and passed measures proven to help save lives. In 2014, the Minnesota like Colorado where state Senator Kevin Lundberg observed, “This issue Legislature passed “Steve’s Law,” allowing for first responders and third [of opioid overdose] is significant enough that we need to be part of the parties to carry and administer naloxone. This legislation provides limited solution, not just watch the problem.” immunity for the person calling for help when someone is overdosing, The legal measures described here were designed in part to help physicians and legal protection for the prescriber and the person administering the feel more support and act in ways better aligned with patient health, rather medication. The following year the Legislature was able to secure $270,000 than business imperatives. Even if a single physician occasionally is able to for naloxone for eight EMS districts. With these prior achievements in mind, The Product Stewardship bill was introduced in both the House One year after Prince’s death to page 424

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3One year after Prince’s death from page 41 strictly curtail the amount of opioids they personally prescribe, that will not have any overall meaning in terms of outcomes unless the whole profession buys in and changes together. This is where legal measures, as expressions of the will of the people, have a completely appropriate role.

Accountability

and accumulative even though they lead to bad outcomes. However, many of these tragic outcomes are preventable. We know this for a fact because we did not die at this rate 20 years ago. And even if death by addiction is due to a thousand bee stings, it is still the bees that did it, not the patient—at least with respect to our ability to control exposure to prescribed opioids.

It is long past the time for us to better manage our hive. It is time to work together and take bold steps to stop this obscene tragedy. We must do this in memory of Prince and the thousands of others that have died too soon.

One of the great challenges in trying to fix a Physicians are actively putting problem such as opioid overdose is that, in terms patients’ lives at risk. of accountability, the final lethal act is always selfChris Johnson, MD, is an emergency physician inflicted as was the case with Prince. This allows working for Allina Health Urgent Care. He is medical providers, or even society in general, to the chair of the Department of Human Services “blame the patient” in a way that is not possible Opioid Prescribing Work Group and serves on when medicines were found to be unacceptably the board of trustees for the Minnesota Medical risky for causing other conditions. For example, Association and the board of directors for the no doctors insisted that thalidomide still helped “some patients” and Steve Rummler Hope Foundation. should be kept on the market despite revelations that it caused flipper limb deformities in a small but significant number of newborns. A number of Senator Chris Eaton, RN (DFL), represents Minnesota Senate District physicians continue to make that claim with respect to opioids for chronic 40, which includes Brooklyn Center and Brooklyn Park. She serves as the pain. Furthermore, death by addiction to opioids has often been described as ranking minority member of the Environment and Natural Resources death by a “thousand bee stings.” With so many prescriptions from multiple Policy and Legacy Finance committee as well as a member of the Health doctors for years, it is not fair or appropriate to single out one that proved and Human Services Finance and Policy committee and full Finance to be the ultimate culprit, not even the last one. Additionally, our medical committee. Senator Eaton is also a member of the Opioid Prescribing Work malpractice laws do not have any provision for processes that are gradual Group run through the Minnesota Department of Human Services.

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Ely Bloomenson Community Hospital is

SEEKING TO EXPAND OUR SURGICAL AND SPECIALTY SERVICES! • WE will work around your schedule and practice!

• WE will accommodate your calendar with as little as one surgery day per month!

• WE have two surgery suites, modern equipment and trained staff to assist you!

• WE are an independent, critical access, community owned hospital with flexibility in working with other health systems!

• WE want to work with YOU!

Practice Details • 21 Bed Critical Access Hospital / Level 4 Trauma Center • 3,000 ER patients seen annually • Lab and Diagnostic Imaging readily available • Nearest Level 2 Trauma Center – 120 miles away • 7 ER rooms Ely Bloomenson Community Hospital borders the vast acreage of the Boundary Waters Canoe Area Wilderness providing recreation opportunities including fishing, camping, and canoeing just to name a few. Ely, itself, surrounded by 35 lakes provides outstanding family amenities including a community focus on education (Pre-K - 12 and Vermilion Community College) offering excellent courses of study. Performing arts, festivals, concerts, parks, beaches and a golf course provide a quality of life in Ely that other people across the country only dream about!

We welcome all interested Surgeons or Specialty Service Providers to contact Patti Banks at

218.365.8765 or pbanks@ebch.org

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3Antimicrobial materials in health care facilities from page 25 With the continued use of antimicrobials in our environments, the risk that we become immune to antibiotics used to treat bacterial infections grows.

Harmful to human health The Healthy Building Network is an organization established in 2000 to reduce the use of hazardous chemicals in building products as a means of improving human health and the environment. Its Pharos Project researchers have identified triclosan as “both a potential asthmagen, and a persistent bioaccumulative substance that can build up in humans.” Their research also found dioxin residuals, known as potent carcinogens and endocrine disrupters, as a common contaminant in this antimicrobial.

The National Institutes of Health has designated QACs categorically as being asthmogenic (causing asthma, not just triggering an asthma attack), irritating to eyes or skin, flammable and corrosive, harmful to aquatic ecosystems, and persistent in the environment.

Harmful to the environment There is mounting evidence that antimicrobial additives leach out of products and ultimately end up in the general environment. The National Institute of Standards and Technology recently reports that nanoparticles can migrate from flooring finishes and indoor paints because of cleaning processes. More study is needed to understand how these particles move about and accumulate in spaces.

The Swedish Chemicals Agency found that in some cases, as much as 98 percent of the antimicrobial silver was lost from articles of clothing over 10 washes. These particles then end up in wastewater treatment plants and could be included in sludge that is sometimes used as crop fertilizer, where they enter the ecosystem. Nanosilver is considered toxic to aquatic plants and animals as well as hazardous to organ growth.

In a summary of literature available in 2014, one researcher writes: “[Triclosan] has been detected in drinking water resources, 75% of urine samples representative of the U.S. population, 97% of representative U.S. breast milk samples, and combined [triclosan and related compound triclocarban] constitute over 60% of the total mass of 96 pharmaceuticals detectable in municipal sludge using EPA Method 1694. Indeed, the environmental ubiquity of both chemicals has escalated such that [triclosan,

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What are your colleagues doing?

In a December 2015 press release, Kaiser Permanente announced their rejection of antimicrobials for infection control (https://share. kaiserpermanente.org/article/kaiser-permanente-rejects-antimicrobialsfor-infection-control). Stating concerns about “mounting exposure to toxic chemicals in everyday life and the threat of drug-resistant bacteria,” they decided to ban paint and other interior building products treated with 15 specific antimicrobial agents. Kathy Gerwing, vice president of Employee Safety, Health, and Wellness and Kaiser Permanente’s environment stewardship officer, said, “removing antimicrobials from interior products is an extension of our longstanding efforts to create healthier environments for everyone.”

Not all microbes are bad.

In 2014, The Swedish Chemicals Agency proposed that silver zinc zeolite be classified as a reproductive toxicant, after an assessment done as part of an ongoing review program presented reviewers with “a relatively clear cut case” that the substance could be harmful to reproductive health.

In the dossier prepared in support of silver zeolite’s reclassification, results of animal testing are cited as evidence that the substance should be considered a suspected carcinogen, an eye and skin irritant, capable of causing damage to unborn children, and capable of causing damage to internal organs. If adopted, the classification as a reproductive toxicant would make silver zinc zeolite a banned substance under the European Union’s Biocidal Products Regulation.

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related antimicrobial triclocarban used in cosmetics,] or both compounds are now detectable in house dust worldwide, in ocean water, and locations as remote as the water loop of spacecraft.”

The elimination of antimicrobials in interior products is a part of the Healthier Hospitals Initiatives Safer Chemicals challenge. Their healthy interiors factsheet notes, “Triclosan and triclocarban are explicitly prohibited (http:// healthierhospitals.org/hhi-challenges /saferchemicals). No other added or built-in chemical antimicrobials are allowed unless they are registered with the U.S. EPA… and have published data that show efficacy in a hospital/clinical setting measured by a reduction in healthcare-associated infections as a part of comprehensive infection control measures.”

With the publishing in March 2017 of a white paper titled “Healthy Environments: Understanding Antimicrobial Ingredients in Building Materials” (https://perkinswill.com/sites/default/files/Antimicrobial_ WhitePaper_PerkinsWill.pdf ), Perkins+Will announced that they have added products marketed as antimicrobial to their Precautionary List (http://transparency.perkinswill.com). Perkins+Will is directing its project teams to advise clients of reasonable alternatives where appropriate.

Conclusion As designers and purchasers of building products, health care architects and health care providers have the power to transform the industries who develop and manufacturer those products. A lack of transparency on which products contain antimicrobials makes it challenging to avoid them. As we select materials, it is advisable to ask about the make-up. This helps manufacturers understand the need to be more transparent as well as highlights what the health care industry wants in facilities as they develop new products. For now, the best policy is to avoid products that are marketed as antimicrobial and seek better alternatives.

Sandra J. Christie, AIA, LEED AP BD+C, is a registered architect and senior associate who leads the Healthcare Group in the Minneapolis studio of Perkins+Will. As a research-driven architecture firm, Perkins+Will is a national leader in the design of healthy indoor environments.

WE PRACTICE WHOLE LIFE CARE We get to know our patients, how their personal lives and social dynamics affect their health. We create individualized care plans and long-term, trusting relationships that are the key to Whole Life Care. We are currently seeking new physician associates in the areas of:

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3Shedding new light on health care from page 21 red lights caused few negative effects on the mood of those same workers.

Architects must challenge themselves to rethink how they approach lighting to maximize the potential benefits.

For patients Programming LED to mimic the circadian cycle, is also beneficial to patients whose natural cycle is disrupted by stress and pain. For patients, during the daytime, lighting typically follows the sunâ&#x20AC;&#x2122;s pattern of brightness and hue (just short of full sunny noon) then slowly dims to evening sunset depending on the geographical position of the facility. Light levels should remain at a safe sunset or twilight setting for the remainder of the evening.

Patient safety is also enhanced through a lighting scheme that is designed to optimize wayfinding. Slips and falls are a major source of injury in and about patient rooms (see Figure 4). A diversified lighting scheme can provide emphasis or provide camouflage in wayfinding. A good wayfinding system can help reduce patient and visitor anxiety. LED technologies have allowed for the development and patenting of many products for health care. For instance, the light fixture manufacturer Cooper produces a touch-sensing fixture for patient headwalls called the Balance Beam. This multifunction product allows illuminated support for patients exiting their beds, but more significantly at night, itâ&#x20AC;&#x2122;s calibrated to be non-disruptive to the sleep system.

The Balance Beam can also be programmed to alert the nursesâ&#x20AC;&#x2122; station that a patient is mobile. This patient safety device became possible only through the advancement of LED. There are many environmental factors that are

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JUNE 2017 MINNESOTA PHYSICIAN

hard to control in hospitals, however lighting is an aspect that if planned well, can make a measurable difference.

Enhanced aesthetics LED can also be used to add artistic improvements to health care facilities.

Designers can consider LED lighting and how it can help bring greater identity to the exterior of the building making it a beacon to the community, a destination landmark in the evening sky. The cost of illuminating the building exterior has reduced substantially as a result of LED and its programmability.

When designing new projects, architects must help stakeholders move their thinking beyond what is familiar and educate them about how new lighting designs can benefit patients and providers. Architects must accept the challenge of designing new and innovative lighting by taking full advantage of new technology, including LED and pushing boundaries beyond the traditional. A well-thought-out lighting design will have considerable impact on the health and well-being of patients and their care providers. It will help make facilities welcoming, safer, and more productive to all of those who enter.

Renaldo Pesson, NCIDQ, IIDA, AAIA, is an associate partner at E4H Environments for Health Architecture, an architecture firm focused exclusively on the health care and health innovation industry. He holds a U.S. patent for the Balance Beam and received a lighting design award from the Illuminating Engineering Society of North America.

ANNOUNCEMENT

I CAN DO ADVENTURE The approaching holiday season is about hope, magic and miracles. So too, is Diveheart. The Downers Grove-based not for profit organization provides hope, magic, and even miracles, to individuals with disabilities.

Diveheart offers children, veterans and others with disabilities the opportunity to escape gravity through Scuba Therapy. Diveheart participants include individuals with virtually any type of disability including Down syndrome, autism, cerebral palsy, paraplegia, blindness, deafness, spinal cord injuries, traumatic brain injury, post-traumatic stress disorder and more.

HOPE The Diveheart vision is to unleash the unrealized human potential that often exists in individuals with disabilities. The confidence, independence and self-esteem realized by Diveheart participants is tremendous.

Diveheart helps individuals focus on what they can do, rather than what they can’t do.

MAGIC Diveheart Scuba Therapy helps participants focus on their abilities, rather than their disabilities. This helps them to take on challenges that they may never have taken on before. Furthermore the forgiving, weightless environment of underwater offers buoyancy and balance to individuals who might struggle on land. They’re often able to move in ways that are impossible before joining a Diveheart program. Zero gravity is the great equalizer.

MIRACLES Diveheart participants have experienced improved range of motion, ability to focus, pain relief and more. The aspect of pressure while diving provides benefits for people with autism and chronic pain due to spinal cord injuries. Some tell us that after diving, they’re pain free for up to three weeks, often for the first time since their injury.

Every one is able to help perpetuate hope, magic and miracles during the holiday season. Your donation helps to make it possible for individuals with disabilities to experience Scuba Therapy, and the resulting benefits so that they might “Imagine the Possibilities” in their lives. Please visit www.diveheart.org/donate/ to learn more about how you can help promote the hope, magic and miracles of Diveheart. Diveheart donations are also accepted at 900 Ogden Ave #274 Downers Grove, Illinois 60515.

Jim Elliott Founder & President Diveheart

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