Minnesota physician November 2017

MINNESOTA

NOVEMBER 2017

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXI, No. 8

A better way to treat chronic pain Alternatives to opioids

BY NIMA ADIMI MD, MS

C

hronic pain is one of the biggest medical problems facing the world today. As medicine advances and people live longer the incidence and prevalence of chronic pain will only increase given the inevitable degeneration of our bodies. Chronic pain is an unpleasant sensory or emotional experience associated with actual or potential tissue damage, or described in terms of such damage for at least three months.

As a physician I have always been interested in statistics. Numbers put things into perspective for me so here are some alarming statistics regarding chronic pain:

Reducing failure to diagnose claims What to do when patients decline cancer screening

BY GINNY ADAMS, RN, BSN, MPH, CPHRM

D

iagnostic error is the most frequent allegation in medical professional liability (MPL) claims involving death, according to the National Patient Safety Foundation in 2014. It is the number one cause of MPL claims for all primary care specialties, radiology, and emergency medicine. Claims alleging a failure to diagnose cancer are among the most numerous and most costly examples of diagnostic error. Several issues underlie many of these cancer claims, including the failure to offer or provide appropriate cancer screening.

Reducing failure to diagnose claims to page 164

• Over 100 million Americans and 1.5 billion people worldwide struggle with chronic pain. • Chronic pain is the number one cause of A better way to treat chronic pain to page 184

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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NOVEMBER 2017 MINNESOTA PHYSICIAN

No-see, no-handle needle No reconstitution required No need to dial a dose 1,2

TrulicityÂŽ (dulaglutide) 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.

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

MINNESOTA PHYSICIAN NOVEMBER 2017

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Preparation2 •

Check the pen to be sure it is not expired, damaged, cloudy, discolored, or has particles in it

•

Choose an area for injection (abdomen or thigh), being sure to choose a different site (even within area) each week

The key administration steps

Disposal2

2

•

1

2

3

Uncap the pen

Place and unlock

Press and hold

Dispose of the pen in a closable punctureresistant container and not in household trash

Please review the full Instructions for Use with your patients to ensure they understand how to properly administer Trulicity.

Select Important Safety Information • Trulicity is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia

syndrome type 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components.

• Cases of medullary thyroid carcinoma (MTC) in patients treated with liraglutide, another 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.

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NOVEMBER 2017 MINNESOTA PHYSICIAN

Yes, I think I can do this

*

In a study, 99% of patients reported that overall, the Trulicity Pen was easy or very easy to use3

•

Patients with type 2 diabetes who were naïve to self-injection and injecting others (n=214) participated in a phase 3b, multicenter, open-label, single-arm, outpatient study on the safe and effective use of the Trulicity single-dose pen

•

The primary objective was to achieve a final injection success rate (proportion of patients who successfully complete injection) significantly greater than 80%

•

Patients were trained at baseline on proper self-injection technique with the pen

•

Final injection (4th weekly injection) success was observed in 99.1% [95% CI: 96.6% to 99.7%] (n=209) of patients (primary objective met). Success determined by evaluation of patients’ ability to accurately complete each step in the sequence of drug administration

•

After the final self-injection, patients completed a 12-item ease of use module (secondary endpoint). 209 (99%) out of 210 patients reported that overall, the single dose pen was “easy” or “very easy” to use

To see how Trulicity can help your patients start injectable therapy, visit Trulicity.com/yesican

*Patient will need additional assistance from their healthcare professional as well as to review the full Instructions for Use included with the Trulicity Pen. Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages and accompanying Brief Summary of Prescribing Information.

Please see Instructions for Use included with the pen.

MINNESOTA PHYSICIAN NOVEMBER 2017

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

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

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

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

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

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

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

Hypersensitivity Reactions: 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.

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NOVEMBER 2017 MINNESOTA PHYSICIAN

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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.

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.

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

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

Please see Instructions for Use included with the pen.

DG HCP ISI 06FEB2017 Trulicity® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Trulicity is available by prescription only.

Other product/company names mentioned herein are the trademarks of their respective owners.

References 1. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC. 2. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 3. Matfin G, Van Brunt K, Zimmermann AG, et al. Safe and effective use of the once weekly dulaglutide single-dose pen in injection-naïve patients with type 2 diabetes. J Diabetes Sci Technol.

2015;9(5):1071-1079.

©Lilly USA, LLC 2017. All rights reserved.

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.

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.

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

DG HCP BS 10FEB2017 7 x 9.5

Trulicity, DG HCP BS 10FEB2017 7 x 9.75

DG HCP BS 10FEB2017 7 x 9.5

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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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DG HCP BS 10FEB2017 7 x 9.5

Trulicity, DG HCP BS 10FEB2017 7 x 9.75 NOVEMBER 2017 MINNESOTA PHYSICIAN

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)

DG HCP BS 10FEB2017 7 x 9.5

PRINTER VERSION 2 OF 2

TH 48 SESSION

NOVEMBER 2017

|

REGENERATIVE MEDICINE:

Volume XXXI, Number 8

Efficacy, Economics, and Evolution

COVER FEATURES Reducing failure to diagnose claims What to do when patients decline cancer screening

A better way to treat chronic pain Alternatives to opioids

By Nima Adimi MD, MS

By Ginny Adams, RN, BSN, MPH, CPHRM

DEPARTMENTS CAPSULES

10

MEDICUS

13

INTERVIEW

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Helping patients live life to the fullest Julie Mayers Benson, MD, Lakewood Health System

PUBLIC HEALTH

Minnesota Medical Cannabis Program First year patient experiences

By Tom Arneson, MD, MPH

REGENERATIVE MEDICINE 32 Breakthrough T cell therapies Commercialization requires additional innovation

By Jeff Liter

E-HEALTH 30

Tuesday, December 12, 2017, 1-4 pm

The Gallery, Downtown Minneapolis Hilton and Towers 34

Intellectual or developmental disabilities Using e-technology to broaden the care team

By George Klauser

About, objectives, background and focus: The Minnesota Health Care Roundtable is a semi-annual conference featuring a panel of stakeholder group experts in a moderated discussion before a live audience covering topics that affect the evolution of health care policy.

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.

SPECIAL FOCUS: RURAL HEALTH Universal platforms A new approach to facilities design

By Jennifer Klund, AIA, ACHA, and Amy Douma, AIA, LEED AP

22

The rural Minnesota clinician workforce

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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.

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Panelists include:

Retention, then recruitment

By Kevin Gish, MHA, LNHA, and Charles Winjum, MD Precision medicine in rural Minnesota What does it look like?

By Paula M. Termuhlen MD, FACS, and Ruth Westra, DO, MPH Workplace violence in a medical center

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Assessing your preparedness

By Stacy Barstad

Blake Johnson, MD Center for Diagnostic Imaging

Roger Hogue, MD Minnesota Regenerative Medicine

David R. Brown, MD Children’s Minnesota

David Largaespada, PhD Institute for Molecular Virology

Meri Firpo, PhD Stem Cell Institute

Sponsors include:

PROFESSIONAL UPDATE: CARDIOLOGY

Center for Diagnostic Imaging · Recombinetics · Minnesota Regenerative Medicine

Transcatheter aortic valve replacement A unique and transforming procedure

By Gregory Helmer, MD, and Ganesh Raveendran, MD, MS

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9

CAPSULES

Licensing Laws Keep Physicians from Seeking Mental Health Care Many physicians avoid seeking necessary mental health treatment due to concern for their medical license, according to research from Mayo Clinic. The researchers found that licensing requirements in many states include questions about past mental health treatments or diagnoses.

“Clearly, in some states, the questions physicians are required to answer to obtain or renew their license are keeping them from seeking the help they need to recover from burnout and other emotional or mental health issues,” said Liselotte Dyrbye, MD, physician at Mayo Clinic and first author of the article.

For the study, researchers examined the licensing documents for physicians in all 50 states and Washington, D.C., and renewal applications from 48 states. They found that about one-third of states were consistent with the American Medical

Association, American Psychiatric Association, and Federation of State Medical Board policies and recommendations, or in clear compliance with the Americans with Disabilities Act of 1990. Those states only asked about current medical or mental health conditions that impair a physician’s ability or did not ask about mental health conditions at all. However, the majority of documents asked varying questions, including questions about past diagnoses or treatments for mental health problems.

The researchers also collected data through a national survey of more than 5,800 physicians, including questions about their attitudes on seeking care for mental health issues.

Results of the survey showed that nearly 40 percent of respondents said they would hesitate in seeking professional help for a mental health condition because they feared doing so could have a negative impact on their medical license. Physicians from the states that ask questions about past diagnoses or treatments for mental

health problems were 21 percent more likely to be reluctant to seek help for a mental health condition.

Changing the licensing regulations in these states would be a simple but important step in reducing barriers to physicians seeking help, according to the research team.

Partnership Improves Care, Lowers Costs An analysis of the Northwest Metro Alliance, an accountable care organization (ACO) partnership between Allina Health and HealthPartners, has shown that health care costs in Anoka and southern Sherburne counties are increasing at a slower pace than the metro area average. The ACO serves a community of about 600,000 people who receive care at Allina Health and HealthPartners clinics and Mercy Hospital.

An executive summary of the first seven years of the partnership shows that costs rose on average by less than 3 percent per year, compared to a

more than 8 percent increase in the year before it began.

The health care systems attribute the reduction in annual cost increases to care improvements such as reducing hospital readmissions, increased use of generic medications, and expanded access to outpatient mental health care.

Since the partnership began, the rate of preventable readmissions decreased by more than 25 percent, saving about $11,220 to $13,000 per readmission, and prescriptions for generic medications have increased from 75 percent to 91 percent, saving an estimated $3.4 million per year in drug costs.

The Alliance also opened a short-term residential facility for mental health with 16 beds and expanded Mercy Hospital’s partial hospital day-treatment mental health program to serve more than 4,500 patients per year, helping offset the more than 5,000 visits to the Mercy Hospital emergency department each year.

The Alliance continues through 2019, with an opportunity to extend the partnership.

V PTSD is now an approved condition V

HAVE YOU REGISTERED WITH THE MINNESOTA MEDICAL CANNABIS PROGRAM? Registration can be done online; there is no fee and it takes only a few minutes.

Visit the registry website: mn.gov/medicalcannabis Your account will provide access to medical cannabis purchasing information from patients you certify.

Once you are registered, you will be able to certify patients with a variety of conditions, including: • Cancer, Glaucoma, Tourette Syndrome, HIV/AIDS, and ALS

• Inflammatory bowel disease, including Crohn’s disease

• Seizures, including those characteristic of Epilepsy

• Terminal illness, with a probable life expectancy of less than one year • Intractable Pain • Post-Traumatic Stress Disorder

• Severe and persistent muscle spasms, including those characteristic of MS

Cannabis Patient Centers are now open to approved patients in Minneapolis, Eagan, Rochester, St. Cloud, Moorhead, Bloomington, Hibbing, and St. Paul.

OFFICE OF MEDICAL CANNABIS

(651) 201-5598: Metro (844) 879-3381: Non-metro P.O. Box 64882, St. Paul, MN 55164-0882 health.cannabis@state.mn.us

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NOVEMBER 2017 MINNESOTA PHYSICIAN

Many patients have reported improvement in their health status from medical cannabis — some describing dramatic improvements. Smoking cannabis is not allowed under the program.

Visit our website for educational resources about cannabinoids and the endocannabinoid system and for scientific literature on the efficacy of medical cannabis in treating certain conditions.

See our website for a detailed first year report. mn.gov/medicalcannabis

CAPSULES

CentraCare Expanding in Central Minnesota CentraCare has opened a new walk-in clinic in the Cash Wise grocery store in Waite Park and broken ground on its Coborn Cancer Center’s Coborn Healing Center in St. Cloud for patients who have experienced cancer.

The new quickClinic at Cash Wise is in partnership with Coborn’s, Inc, owner of the Cash Wise grocery store chain. It has two exam rooms and offers treatment for common health concerns, including skin conditions, cold and flu, minor injuries, vaccinations, wellness screenings, and physicals.

Two more quickClinics are set to open in the coming months at Coborn’s-owned grocery stores in Foley and Sartell.

The 6,500-square-foot Coborn Healing Center will offer services for the mind, body, and spirit for people who begin or continue their cancer journey at Coborn Cancer Center. Programming will include art and music therapy, support groups, spiritual well-being, fitness classes, integrative therapy (such as acupuncture, massage, and healing touch), and an interactive kitchen/classroom.

Its estimated completion date is summer 2018. The CentraCare Health Foundation raised more than $3 million over the last two years through community, private, and business donations to cover the cost of the project.

No new jobs are expected in the new building, as resources will be shifted from within the CentraCare health care system.

MHA Study Projects Physician Shortage A new study conducted by the Minnesota Hospital Association (MHA) has confirmed that a shortage of primary care physicians will develop in the state over the next decade.

MHA collects health care workforce data from most Minnesota

hospitals each year and this year, for the first time, MHA called on Towers Watson, a global professional services company, to conduct a comprehensive review of the state of the primary care physician and registered nurse workforces in Minnesota. The company used publicly available data from the Bureau of Labor Statistics and the state of Minnesota in addition to the hospital workforce data provided to MHA. “The current pipeline of graduates appears adequate to replace retirements as they occur. That, coupled with projected increases in demand because of an aging population, will result in a significant talent gap for physicians,” the review concluded.

Specifically, a cumulative shortfall of nearly 850 primary care physicians is projected for the Minnesota workforce by 2024 due to the lack of annual growth in Minnesota’s graduate medical education programs, including residency or clinical training positions. The study showed that the number of openings for residency programs has been frozen since 1996. However, the supply of registered nurses will likely meet the demand, assuming that education programs continue to grow at their expected rate.

In response to the findings, MHA is urging federal and state policy makers to lift the 17-year freeze on the number of physician residency positions available under Medicare funding; oppose cuts to federal Graduate Medical Education Funding; develop a statewide health care workforce plan; seek ways to increase funding of Minnesota’s Medical Education and Research Costs program; and support development of new primary care models, including telehealth technology.

In addition, MHA is encouraging the Minnesota Department of Human Services to implement temporary payment increases for primary care services delivered to Medicaid patients as called for under federal law.

Creating rural healthcare leaders Rural Healthcare MBA As a physician working in rural healthcare, complement your role and perfect your leadership skills with the courses offered in our MBA in Rural Healthcare. The curriculum focuses on health care economics, finance, organizational behavior and development and provides the tools to be a successful leader in the rural medical field.

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go.css.edu/rural

Transitional Care Unit Grand Opening October 20, 3-6pm Ribbon Cutting Ceremony 3:30 pm

Back to health. Back to home.

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612.379.1370 | catholiceldercare.org 149 8th Avenue NE, Minneapolis, MN 55413 MINNESOTA PHYSICIAN NOVEMBER 2017

11

CAPSULES

To the Editor: I am writing in response to the article on quality reporting by Paul Kleeberg and Phil Deering, published in Minnesota Physician’s September 2017 issue. The article highlights the importance of social factors that are beyond the control of individual physicians, and how these factors contribute to variation in quality measures. I agree with the authors’ perspective on the influence of social factors, and also with their viewpoint on the importance of devising payment methods that appropriately account for the challenges of serving populations that are socioeconomically disadvantaged.

The article stated that MN Community Measurement does not take differences in patient populations into account. However, we have been working for several years, in consultation with stakeholders including representatives from safety net providers, to appropriately risk adjust quality measures to reflect differences that are beyond the control of physicians. Beginning with clinic performance for 2013, MN Community Measurement has published risk-adjusted measures in its reports and on its website. Our approach has evolved and improved over time along with the science of risk-adjusting quality measures. Importantly, in 2018, MN Community Measurement will add a ZIP code level “deprivation index” to its risk adjustment process to explicitly recognize the contribution of socioeconomic factors to variation in outcomes.

We will likely never reach a perfect solution to this challenge, but I welcome and encourage continued stakeholder engagement in this work.

It is important that we keep working on these issues, and that we continue to do so together.

Julie J. Sonier President, MN Community Measurement

invites you to:

The Importance of Independent Physician Practice

Thursday, January 18, 2018 · 1:00 – 4:00 p.m · Radisson Roseville ·2540 Cleveland Ave, Roseville, MN

(35 W at County Road C)

We invite physicians and their managers, elected officials and their staff, employer/purchasers and others interested in the effects of over-consolidation on patients and their physicians 1:00-1:30 – Opening remarks: The joys and challenges of independent practice Eric Becken, MD – Midwest ENT, Chairman-Collaborative Care Cooperative

1:30 – 2:30: Connecticut’s journey to reform its consolidated delivery system How policy makers in one state began working together on combating provider consolidation and skyrocketing health care costs.

Dina Berlyn, J.D. – Counsel to Connecticut State Senate President Pro Tempore

2:30-3:00: The challenges of payer contracting as an independent physician Perspectives from Greater Minnesota Dr. David C. McKee, Chief Medical Officer, Integrity Health 3:00-3:45: Panel discussion: What can be done in Minnesota to improve the environment for independent providers Key elected officials, physician leaders and Connecticut guests 3:45-4:00 – Concluding remarks: Moving forward Eric Becken, MD

Jennifer Macierowski, J.D. – Chief Counsel, Senate Minority Office

Registration is required: Contact Annaliese.Minette@cdirad.com or call 952.738.4693 to register 12

NOVEMBER 2017 MINNESOTA PHYSICIAN

MEDICUS

Judith Kaur, MD, a medical oncologist at Mayo Clinic, has received the Richard Swanson Humanitarian Award from Augustana College for her work studying cancer among Native Americans. She serves as hospice medical director, professor of oncology, and medical director for the Native American Programs in the Mayo Clinic Cancer Center and is involved in national research and outreach programs to American Indians and Alaska Natives. Kaur, a member of the Choctaw Tribe, aims to improve cancer screening, access to care including clinical trials, and efforts to increase survival rates in native populations. Her recent research looks at the role of diet, exercise, smoking, alcohol, and genetics. She is also analyzing possible health similarities between U.S. tribes and other countries, including China and Africa. She earned her medical degree at the University of Colorado Health Sciences Center.

– Jan 1 Nov 25 A Minnesota Orchestra Christmas: Home for the Holidays

Jakub Tolar, MD, PhD, has been named dean of the University of Minnesota Medical School. He replaces Brooks Jackson, MD, MBA, who held the position for three years. Tolar has also been named interim vice president for health sciences, a position that Jackson also previously held. Jackson has taken the position of vice president for medical affairs and dean of the Roy J. and Lucille A. Carver College of Medicine at the University of Iowa. Tolar, originally from the Czech Republic, has been with the University of Minnesota for 25 years. Most recently, he served as executive vice dean of the medical school and director of the Stem Cell Institute for a year. He also has a clinical practice through the University of Minnesota Masonic Children’s Hospital. Tolar completed medical school at Charles University in Prague, Czechoslovakia, and began studying at the University of Minnesota in 1992, where he completed his PhD in molecular, cellular, and developmental biology and genetics.

Nancy Hutchison, MD, a physiatrist at Allina Health specializing in cancer rehabilitation, has received the 2017 Medical Champion of the Year award from Cancer Legal Care for her contributions to the Minnesota-based organization. Hutchison served as medical director of cancer rehabilitation at Allina Health from 2005 through 2016. She is on the Steering Committee of the Minnesota Cancer Alliance, where she is charged with implementation of the state cancer plan. She is also a certified lymphedema therapist through Klose Training and holds certification by LANA, the Lymphology Association of North America. Hutchison earned her medical degree from Wake Forest University School of Medicine in Winston-Salem, NC. John Mach, Jr., MD, has been named Medica’s new chief medical officer. He succeeds Alan Spiro, who held the position since July 2016. Mach has more than 31 years of medical experience. Most recently, he served as chief medical officer for Evolent Health in Arlington, VA. Before that, he served as the president of complex care management at Univita Health Inc., based in Miramar, FL. He has also served as chief medical officer at several organizations, including UnitedHealth Group, where he also served as chairman and chief executive officer of its Evercare division. He earned his medical degree at the University of Minnesota Medical School.

Merry and Bright

A New Year Celebration: Tchaikovsky Piano Concerto No. 1 An Evening with George Winston

Rufus Wainwright with the Minnesota Orchestra

A Christmas Oratorio

612-371-5656 / minnesotaorchestra.org / Orchestra Hall HARRY POTTER characters, names and related indicia are © & ™ Warner Bros.

Entertainment Inc. J.K. ROWLING`S WIZARDING WORLD™ J.K. Rowling and Warner Bros.

Entertainment Inc. Publishing Rights © JKR. (s17). The Little Mermaid: Presentation licensed

by Disney Concerts © All Rights Reserved. Photo credits available online.

Media Partner:

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13

INTERVIEW

Helping patients live life to the fullest Julie Mayers Benson, MD, Lakewood Health System

You have a special interest in hospice and palliative care. What about this area of care do you think is the most important for physicians to know about?

Palliative care is not hospice and it is not just about dying, it is about living. It is about how to best support patients with serious illness by equipping them with honest information to make difficult decisions. Death and dying are an inevitable part of life. All of our training is focused on making life better and fighting or preventing death. But truthfully, we receive very little training on how to talk to our patients about dying or how to manage the end of their lives. In medical school and our internship year we have at least eight to 12 weeks of obstetrical care training. This is relevant for about 50 percent of our patients and most physicians don’t choose obstetrical care as their career path. But 100 percent of our patients will die and we have no required core competencies in this field. Every specialty needs to know how and when to talk to a patient about progressive disease processes, and how to help a patient prepare for a future of uncertainty and death. We are morally prohibited from abandoning our patients but physicians frequently say, “There is nothing more we can do.” That statement feels like abandonment to many. There is always more we can do—it just may not be a cure. We have to guide our patients to make decisions early, help them live life to the fullest, and relieve stress and symptoms even if it means life will not be prolonged. We owe it to them to be honest and supportive. Prognosis is difficult and we all struggle with the uncertainty. But if we never acknowledge the potential to die, then we rob our patients of the chance to prepare.

You started the hospice and palliative care program at the Lakewood Health System in Staples. What are some of the unique challenges to providing this kind of care in Greater Minnesota?

When we started our program in 2009 there were no rural outpatient models to guide us. We had to start from scratch. We were fortunate to work with Stratis Health, who helped us develop a model that would work in our locale with our small critical access hospital. Back then, payment structure didn’t exist, and the Triple Aim was not implemented so a purely fee-for-service model meant our health

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NOVEMBER 2017 MINNESOTA PHYSICIAN

system would lose money on the front side. The data found that palliative care saved money but that was for hospital-based tertiary care facilities. However we had amazing support from our administration who

transportation is limited. I have patients that can’t afford the gas to go 30 miles to see a specialist or to a 24-hour pharmacy and so may go without critical medications. Food insecurity is real here.

The cost of fresh fruit and vegetables, especially in the winter, is prohibitive for many and so cheap food contributes to our obesity epidemic. We have tried to bridge that gap with an innovative program that allows food insecure families and elders to receive a CSA share every week from our local farmer’s market. And we are working on ways to continue that through the more difficult winter months.

What impact has the opioid epidemic had in your community?

Many physicians “...” practicing in rural areas enjoy greater independence and diversity in care. “...”

felt that it was the right thing to do and the finances would work out if we just took care of people.

What can you tell us about the Minnesota Network of Hospice & Palliative Care (MNHPC)?

MNHPC is Minnesota’s largest network of hospice and palliative care providers. We provide education and support to our members, offer the nation’s largest state educational conference each spring, advocate on behalf of patients and agencies to the Legislature, and connect patients and families to appropriate services in their area.

There are a great number of challenges unique to practicing medicine in smaller rural Minnesota communities. Can you share your thoughts about these challenges?

Resource scarcity is one of the biggest barriers to access. We don’t have much public transportation and no bike lanes so multimodal

The opioid epidemic has definitely made its presence known here. We see increased associated ED visits, families devastated by addiction, addicted teens, newborns suffering withdrawal, and legal issues. We developed a pharmacist-run program to help patients wean from their prescription medications. We also have an active community group dedicated to educating our population and working together to find social ways to deal with the epidemic.

Social disparities and a growing immigrant population create new issues for health care delivery. Have you seen this in your area?

I practice in some of the poorest counties in Minnesota, and the disparity between those that have and those that don’t is growing. And the resource scarcity makes this divide harder to overcome. It is difficult for residents to increase their earning capacity without public transportation, adequate childcare, and teen activity options.

We do not have a large immigrant population but I expect that to change as more jobs become available in the near future.

How has the Affordable Care Act been a catalyst for your patients and your clinic?

I have personally seen patients and families finally access the care they need when they got health care coverage. Now patients can get crucial medications and behavioral health services. We reduced ED use by adding extra clinic hours and

our clinic added physician extenders to our team, which has been a tremendous benefit.

The pace of innovation in medical science and technology seems to be increasing beyond the ability of our health care system.

How is your clinic addressing this issue?

By virtue of our small hospital and the exorbitant cost of some of this technology we are essentially prohibited from directly offering some of it. That doesn’t mean we use out-of-date EMR or mammography equipment. It just means that we are unable to do heart catheterizations or other complicated procedures. That said, we are aware that this issue comes into play particularly at the end of life. Growing use of the palliative care team means we are having conversations upstream and attempting to help critically ill patients understand their choices. We see patients choose quality care instead of futile care. This will continue to grow as an issue in the future.

The topic of physician burnout and career satisfaction is a growing concern. What are your thoughts on how best to deal with these issues?

I think the changing focus from the Triple Aim to the Quadruple Aim has started systemic thinking

about this problem, but it has been reactionary, not proactive. As a result, the workforce has lost experienced physicians to early retirement or worse. We need to decrease the administrative and regulatory burden of documentation so that physicians can work to the highest level of their license. The amount of paperwork and charting that a physician needs to do is outrageous and usually creates an inefficient bottleneck that costs money and time. Much of this could be relieved by changing insurance structure and government regulations, and letting other highly skilled health care workers actually perform their jobs. I am in favor of quality measures, but not placing that duty solely on physicians.

What advice can you give to young physicians who are considering centering their careers in a more rural environment?

Many physicians practicing in rural areas enjoy greater independence and diversity in care.

I get to do obstetrics, end of life care, hospitalist, emergency care, and outpatient primary care. Rural medicine offers more opportunities than students and residents may know. If you are thinking about rural practice then you need to explore it. Look for rotations in rural facilities. The Rural Physician Associate Program is one of the best ways to get

a true taste of rural medicine. As a nine-month, third year medical school rotation it provides longitudinal experience in family medicine. Even if a student doesn’t ultimately choose primary care, the skills they developed as an independent learner will benefit them in their residency and future career.

Julie Mayers Benson, MD, is a family practice physician at Lakewood Health System in rural Staples and is board-certified in hospice and palliative care.

She attended medical school at the University of Minnesota–Duluth and completed her family practice residency at the University of Minnesota, Riverside.

Her work has ranged from OB and pediatrics to geriatrics and a palliative care program. She is medical director for the Hospice and Palliative Care program and is current president of the Minnesota Network of Hospice & Palliative Care. She was named 2017 Family Physician of the Year by the Minnesota Academy of Family Physicians.

Medical Malpractice defense

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MINNESOTA PHYSICIAN NOVEMBER 2017

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3Reducing failure to diagnose claims from cover

2. Document the patient’s family and personal history of cancer.

3. Recommend appropriate screening exams, using shared There are multiple reasons to provide cancer screening for patients, decision-making. beyond the fact that physicians are in the business of improving and 4. Don’t take the first “no” as the answer. Assess the reasons for safeguarding the health of their patients. Best practice standards are a refusal and consider the possibility of a established by the American Cancer Society and breakdown in communication. the Centers for Disease Control and Prevention, along with numerous specialty organizations that 5. Accept that the patient has the right to provide recommendations in their respective fields. make informed decisions about his or her care.

In Minnesota, mandatory reporting of quality 6. If screening is refused, look for measures through MN Community Measurement Meticulously document opportunities for compromise or to otherwise includes screening for colorectal, breast, and the informed refusal promote health. cervical cancer. Provider and clinic/medical of screening tests.

7. Document all screening tests suggested group success rates for providing this screening is and performed. Meticulously document the publically available on the Minnesota HealthScores informed refusal of screening tests. website (mnhealthscores.org).

Safeguarding patients and physicians What happens when a patient refuses the cancer screening tests? How do practitioners ensure that they are supporting their patient’s individual needs and goals while also protecting themselves from becoming another MPL claim statistic?

The following are important steps practitioners can take to safeguard both patients and themselves: 1. Establish and adhere to the practice’s cancer screening guidelines.

Stay up to date with guidelines.

8. Follow up with the patient.

Sources vary on cancer screening, sometimes to the point of controversy and confusion. Practitioners are not obligated to adopt the guidelines of a particular group; however, if the practice’s guidelines differ significantly from those commonly accepted, the practice should be prepared to defend its reasoning.

An individual’s family history of cancer is crucial in determining his or her risk for developing cancer. It facilitates the stratification of patients into risk groups, allowing practitioners to tailor their discussions regarding individual risks, benefits, and alternatives for a particular screening exam with a patient.

Shared decision-making Your Link to Mental Health Resources

In January 2017, the U.S. Preventive Services Task Force (USPSTF) published its position in Shared Decision making About Screening and Chemoprevention. This consensus paper states: “The USPSTF places a high value on informed and joint decisions about screening and chemoprevention; such decisions are essential for making recommendations to individual patients concerning interventions that have net benefit for some patients, but not for others. One approach to encouraging informed and joint decisions is shared decision-making.”

Shared decision-making is recognized as the ethical model for most encounters in medical practice. It is particularly important when there is more than one reasonable option, as with screening exams. In shared decision-making, the practitioner strives to provide patients enough understandable information so that they can partner with the practitioner in making care decisions. Both the practitioner and the patient have a role and voice in balancing the risks and expected outcomes of a test with the patient’s preferences and values. The standardized decision aides often used in the shared decision-making process can serve as excellent documentation of the information provided to the patient and the process followed in reaching a decision.

Understanding screening refusal If the patient declines an exam, the practitioner should go the extra mile to understand what may be driving that decision. Patients may refuse a screening exam for a whole host of reasons. Some patients do not understand, and indeed fear, the screening process, particularly when it involves an invasive procedure, such as a colonoscopy. Still others fear the results and prefer to believe that in the absence of symptoms, everything is all right. Financial concerns can also lead to patient refusal. Discussing the known costs of a screening exam, assisting the patient in determining

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NOVEMBER 2017 MINNESOTA PHYSICIAN

whether a portion is paid by insurance, and helping the patient investigate other options can help alleviate financial concerns.

It is also important to discuss available alternatives, along with their risks and benefits, even though they may not be as effective. If an alternative plan is developed, the practitioner needs to document the compromise and note that it is due to patient preference and not provider preference.

A patient has the right to weigh all the information provided and to decide against a treatment or procedure. The practitioner may not agree with the patient’s perception of the risks and benefits; however, it is imperative to respect the patient’s wishes once he or she has received information upon which to make an informed decision, understands the implications, and has had an opportunity to ask questions and have them answered.

Cancer screening exams may be viewed as a routine part of patient care, but that does not diminish their significance. A structured process for discussing these tests with patients is important, and when a patient refuses a practitioner’s recommendation, thorough documentation is essential. It not only serves as legal protection, but can also provide the practitioner with peace of mind that the options have been presented in a balanced way and that patient’s right to make his or her own decision has been supported.

Ginny Adams, RN, BSN, MPH, CPHRM, is a senior risk consultant for Coverys, a medical professional liability insurance company. She has a background in critical care nursing, nursing administration, performance improvement, regulatory compliance, and risk management.

Documenting the refusal Then comes the important task of documenting the patient’s refusal to undergo the suggested cancer screening test. Practitioners need to document exactly which test was recommended and why, the alternatives that were presented and discussed, and any teaching regarding the potential consequences of refusing the screening. A form may be used to document the patient’s refusal.

As an example, a note stating that “routine screening was discussed” is a good start, but it is much more powerful for the practitioner to state: “A colonoscopy was recommended to the patient based on his age and family history of colon cancer. The patient verbalized understanding of the risks and benefits of the exam as described in the decision aide provided. The patient also understands the risks of not doing the exam. The patient refuses a colonoscopy at this time, due to concerns regarding the invasive nature of the procedure. Alternative screening methods were offered and explained, including a fecal occult blood test and fecal immunochemical testing. The patient has decided against any screening exams at this time. It was agreed to revisit the issue next year.”

Documentation showing that the patient was fully informed of the risks of refusing the test makes a subsequent malpractice claim more defensible. It serves as proof years later, when a lawsuit would arise, that the interaction actually did occur.

It is not enough to have the discussion once; screening recommendations should be revisited regularly. If the patient continues to refuse screening, the patient’s refusal needs to be documented each and every time.

Tracking scheduled exams The practice should have a system in place to track patients who fail to appear for scheduled screening exams. Patients need to be called to determine why they did not follow through. It is also very important to address any barriers the patient may face to completing the exam and, when appropriate, convey the risks of failing to follow through on the recommended screening. If the practitioner or designee is unable to reach the patient after several attempts, a letter with the same information should be sent. All conversations and letters, as well as attempted telephone contacts should be thoroughly documented.

If an allegation of malpractice is made for failure to diagnose cancer through a screening exam, it is important to note that Minnesota follows the principle of “comparative fault,” as defined in Minnesota Statutes §604.01. Simply put, comparative fault means that the defendant’s liability may be reduced in proportion to the plaintiff ’s fault. If the informed refusal of a screening exam is well documented, the documentation can serve as support for shifting some of the blame to the patient for failure to obtain the recommended exams or treatment.

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17

3A better way to treat chronic pain from cover disability in the U.S. • Seventy-seven percent of people with chronic pain report feeling depressed due to their pain.

opioid epidemic in the U.S. According to the CDC “the overdose death rate has tripled from 1990 to 2013” and is the leading cause of iatrogenic death in patients. Beyond this, physicians are now being held liable for deaths, accidents, and intentional overdoses due to prescribing habits.

But, opiates can have positive uses as well.

Overall they are non-toxic to our organs as opposed • Twenty percent of people with chronic pain to more commonly-used drugs like NSAIDS and have taken long-term disability leave from acetaminophen. They also provide good analgesia work. in the short term. The problems are obvious and • Thirty-six million people have taken days include tolerance, hyperalgesia, addiction, and Chronic pain is the number one off of work in one year due to chronic pain abuse to name a few. Given that Minnesota is cause of disability in the U.S. and we can estimate about $300 billion of where Prince called home, there is a heightened lost productivity due to this. awareness to the opiate problem and a sense of urgency to suppress the epidemic. Given all of this, • Only 23 percent of patients with chronic there is an increased need for physicians, especially pain have found opiates effective. in Minnesota, to find effective alternatives to • The most common types of chronic pain chronic pain. The negatives are that there is still are low back pain, headache/migraine, and neck pain. nothing available both interventionally and pharmacologically that mimics These statistics make it clear that there are a lot of people suffering and the immediate and powerful pain relief of opiates but there are options it not only affects their physical and mental well-being, but also negatively that in the long run provide the same if not better analgesia without the impacts them financially. Chronic pain is real and is not going anywhere so aforementioned risks. we need to learn how to deal with it!

Alternate ways to approach pain

Opiates as a solution Unfortunately, chronic pain has become synonymous with the use of opiates and this association needs to be dissolved. Managing chronic pain with opioid medications has become increasingly more dangerous given the

Your Link to Mental Health Resources

When thinking about treating chronic pain, I focus on a four-pronged approach: 1) functionality, 2) behavioral health, 3) medication optimization, and 4) interventions.

Functionality The first thing to think about is functionality because pain relief without a level of functioning is irrelevant. I expect all of my patients to either participate in physical therapy or an intensive home exercise program to make sure that they stay strong and avoid deconditioning. In the past, physicians and others thought that when in pain, patients should protect themselves by resting. Today we know that this is the wrong approach and the best thing is for patients to exercise and continue to stay active. There are rarely any negative consequences to continuing activities when dealing with chronic pain. In the long run, patients end up desensitizing themselves to the pain.

Behavioral health It’s very important for physicians to consider a patient’s behavioral health. As shown in the earlier statistics, 77 percent of patients who have chronic pain are depressed for a variety of reasons. I always make sure that my patients are seeing a pain psychologist/therapist and learning some relaxation techniques or are provided with enough outlets where these needs are being met. The combination of meditation with cognitive behavioral therapy has been proven to be effective. This is probably the most underrated and undertreated part of chronic pain.

Medication optimization It is very important to be sure that patients are optimized from a medication standpoint. Medications should be introduced with the understanding that most, if not all medications prescribed for pain have side effects. This is an important part of the discussion since there are no silver bullets. That being said, there are some good non-narcotic medications available. The most common, since they are over-the-counter, are NSAIDS and acetaminophen.

Both can provide good relief at therapeutic doses but are not without their

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NOVEMBER 2017 MINNESOTA PHYSICIAN

own risks. NSAIDS are thought to contribute to myocardial disease, GI disturbances including bleeds, and kidney dysfunction. Acetaminophen has led to liver toxicity in overuse and even at therapeutic doses. The neuropathic medications most used are gabapentin and pregabalin.

Both are good drugs and in the case of gabapentin affordable as well.

The problem with gabapentin and pregabalin is that the side effects are hard to tolerate especially in the geriatric population. Other medications including antidepressants like duloxetine, amitriptyline, and nortriptyline are all moderately effective in treating neuropathic pain but the side effects seem to be the limiting factor. Muscle relaxants such as cyclobenzaprine, tizanidine, or methocarbamol are all options that can help a patient with spasms. There are other types of more experimental off-label drugs used and in the pipeline but none are ready to be used in a widespread manner.

Interventions To my mind, the future of pain management lies in interventions. This includes a wide variety of options such as minimally invasive trigger point injections, to implantable devices like intrathecal pumps and spinal cord stimulators. Interventional pain is a relatively new medical specialty that tries to identify and target physical generators of pain by utilizing imaging (fluoroscopy, ultrasound, CT scan) along with minimally invasive techniques. Most of us are familiar with epidural steroid injections, joint injections, and even rhizotomy. We can also use more advanced techniques such as kyphoplasty, neurolysis, and implantable devices. Kyphoplasty and vertebroplasty have provided pain relief for acute and subacute compression fractures for years. These injections have helped people with pain and disability get back to work sooner than expected and stay off of

permanent disability. While spinal cord stimulation has been around for many years, it has had an infusion of advances in the past couple of years.

These advances include high frequency stimulation, burst stimulation, and dorsal root ganglion stimulation. Treating people with spine mediated pain has always been pretty successful, but some of these new technologies have allowed physicians to better treat the more difficult pain conditions such as pelvic pain, abdominal pain, and diabetic neuropathy. This is an exciting time in the field of pain medication given all the advancements. As the therapies continue to improve, our ability to treat pain without resorting to narcotics improves.

Conclusion In the past, chronic pain was considered the worst possible diagnosis as it most likely meant long-term disability with no specific diagnosis or treatment.

Today, with the evolution of advanced imaging, new minimally invasive interventions, and innovations in implantable pain control technologies, interventional pain physicians are able to accurately diagnose and effectively treat chronic debilitating pain previously considered untreatable without high-dose narcotics. We always recommend our primary care and surgical colleagues to consider referral to a pain management specialist prior to putting patients on high-dose narcotics or sending them for high-risk surgeries.

Nima Adimi, MD, MS, is board-certified in pain medicine and anesthesiology.

He joined the MAPS team in 2016 and currently sees patients at the Edina and Chaska locations. Being part of an interdisciplinary team gives him the opportunity to help change the way pain is approached.

MINNESOTA PHYSICIAN NOVEMBER 2017

19

PROFESSIONAL UPDATE: CARDIOLOGY

Transcatheter aortic valve replacement A unique and transforming procedure

BY GREGORY HELMER, MD, AND GANESH RAVEENDRAN, MD, MS

replacement has already increased, rising from a rate of 48 people to 91 per 100,000 person-years in the last decade.

he world of aortic valve replacement has undergone a monumental shift within the past 5–10 years. It all began with a goal to seek alternative and less invasive ways to replace an aortic valve. Evidence supported that there were multiple reasons many patients were not undergoing surgical valve replacement, even though it is a life-saving surgery. The latest success is a minimally invasive procedure called a transcatheter aortic valve replacement (TAVR).

Typically, with AS there is a relatively long asymptomatic phase and a rapid decline, followed by mortality once a patient becomes symptomatic with heart failure, chest pain, or syncope. Often once a patient becomes symptomatic, the only treatment that can extend life expectancy is a valve replacement, and it should be performed shortly after symptoms present.

T

The road to valve replacement surgery What leads a patient to valve replacement surgery varies. Aortic stenosis (AS) is the most common reason for an aortic valve replacement. The prevalence of severe AS has been estimated to be 0.3 to 0.5 percent in the general population, but markedly higher in the elderly—an estimated 2 to 7 percent prevalence in individuals 65 years of age or older. Mitral stenosis, the narrowing of the mitral valve opening that restricts blood flow from the left atrium to the left ventricle, is another condition that sometimes requires a valve replacement procedure.

With the aging population, the prevalence of AS is expected to increase over the next several decades. The number of surgical procedures for aortic valve

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From then, to now In 1953, Hufnagel and Harvey reported the first heterotopic aortic valve replacement. Then in 1960, a patient whose failing aortic valve was replaced with a mechanical Starr-Edwards valve, was first done by Dr. Albert Starr in Portland, Oregon. Surgical valve replacement requires median sternotomy, which means the incision is made by cutting through the sternum or chest bone.

Once the chest was opened, the patient was put on a heart and lung machine that supported the body during the surgical procedure while the heart was stopped. The development of this heart valve marked a new era of treatment at the time. Until then, there were no reports of patients who had lived longer than three months with a prosthetic valve.

Medical experts continued to search for innovative and less invasive ways to approach the procedure. The valves changed throughout those 60–70 years; however, the general principles and techniques have remained relatively similar until recently.

In 2002, Dr. Alain Cribier performed the first transcatheter replacement of the aortic valve for aortic stenosis at the University of Rouen in France.

This was initially performed using the transseptal approach bringing the valve through the venous system. Since that first successful implant, there has been an explosive growth in TAVR procedures in the U.S. and worldwide. Some medical professionals estimate that in the year 2018, the number of TAVR procedures will be greater than the number of surgical aortic valve replacements performed.

Analysts predict an expected annual growth of 20 percent through 2020 for the TAVR market, reaching an approximate value of over $3 billion.

What is TAVR? TAVR is performed by gaining access mainly in the groin by percutaneous method. This means a needle is inserted in the femoral artery followed by wires advanced through that needle. Many of these procedures are done with conscious sedation, which involves a combination of medications meant to help relax and block the pain; however, patients may stay awake or be able to speak throughout the procedure.

Once the wire is in the artery, a large sheath is threaded on the wire and left in place (in the artery). Using the same sheath, a wire is placed across the valve. Simultaneously a final assessment of the implantation angle and sizing of the valve is performed. Once all of the final checks are performed, the valve is delivered on that wire. Most patients have two options for the type of valve. One is a balloon-expandable valve that comes mounted on a balloon. By inflating the balloon, the valve is expanded and stays in place. The other is a nitinol-based self-expanding valve that could be deployed without using a balloon. Careful valve selection is determined by which valve is best suited for that particular

patient.

Once the valve is in good position, fluroscopy as well as an echocardiogram is performed to verify the valve position, check for any paravalvular leaks, and ensure the valve is functioning well. Finally, the delivery catheters are removed from the patients. All the access sites are then closed at the end of the procedure in the operating room.

The total duration of the procedure is around 45â&#x20AC;&#x201C;50 minutes. It was approved by FDA in November of 2011.

Sometimes these procedures cannot be performed using the femoral artery. Around 10 percent of TAVR patientsâ&#x20AC;&#x2122; arteries are too small for femoral access.

Those procedures are performed through alternative sites including subclavian artery, aorta, through the chest wall, and may even be performed through the inferior vena cava.

all aspects of the procedure including increasing the use of conscious sedation compared to general anesthesia. In addition, there has been improvement in large bore closure devices of the access arteries, as well as a newly FDA-approved Sentinel device to capture debris that might have embolized to the brain during valve deployment.

Early recovery is one of the main advantages of the TAVR procedure.

Who is TAVR for?

Initially, TAVR was used for the highest-risk patients. It is currently being performed on intermediate-risk patients, and even on low-risk patients in clinical trials. Most patients typically are discharged from the hospital 24 hours following the TAVR procedure.

More than 400 TAVR procedures have been performed at University of Minnesota Health. The University of Minnesota is currently involved in the PARTNER 3 trial. This is a multicenter international randomized trial comparing surgical AVR to TAVR in low-risk patients (STS <4). The trial is expected to be completed by the end of 2017 with results in 2018.

Valves are currently being researched to be fully repositionable and recapturable, which will lessen the chances of perivalvular leak and decrease the rate of necessity for pacemakers. The University of Minnesota is also involved in the REPRISE III trial using the first fully repositionable TAVR valve randomized for patients at high risk requiring aortic valve replacement.

The adoption of these next-generation valves is expected to drive significant market growth, provided that clinical data continues to show positive mortality and morbidity outcomes for patients. This is an incredibly exciting area of medicine, which combines technological development, innovation, and controlled research trials to optimize patient care.

Gregory Helmer, MD, is a cardiologist and the TAVR medical director with the University of Minnesota Health.

Ganesh Raveendran, MD, MS, is an associate professor of medicine and chief of clinical cardiology with University of Minnesota Health.

Patients who are deemed intermediate to high risk for undergoing traditional surgical valve replacement are considered ideal candidates for TAVR procedures. Patients are considered high risk for surgery when their operative mortality is above 8 percent. They are considered intermediate risk when they have an operative mortality of 4 percent or above. All the patients who fall in this category of intermediate to high risk would qualify for TAVR. Patients in the lesser risk group could also undergo TAVR; however, they should be part of a study and be randomized to either TAVR or surgical valve.

Helping Beautiful Things Emerge From Hard Places

Early recovery is one of the main advantages of the TAVR procedure. The majority of patients will be walking either the same day, that evening, or the following morning. Except for a very small percentage, patients are discharged from the hospital within 24 to 48 hours and back to their normal lifestyle in a week. After a traditional open-heart surgery, patients are kept in the hospital for 7â&#x20AC;&#x201C;10 days. Recovery to normalcy takes several months with restriction on driving for a minimum of two months. Complications related to the TAVR procedures are very similar if not less compared to surgical aortic valve replacement, based on some recent studies.

Making medical headway Not only is the TAVR procedure unique and transforming, but the approach to patient care is one-of-a-kind. The TAVR team consists of a cardiac surgeon, interventional cardiologist, cardiac anesthesiologist, structural echocardiographer, cardiac CT readers, and nurse coordinators. The team meets weekly to review each patient and the optimal care for that patient, allowing full assessment and review of all the medical data and patient interests. This is mandated by CMS and continues to be a requirement of the TAVR program, and no changes to this are anticipated. We believe the team approach to patient care is ideal and that it allows for multiple specialties to give input and expertise.

Along with the advances in valve development, there has been progress in

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21

SPECIAL FOCUS: RURAL HEALTH

Universal platforms A new approach to facilities design

BY JENNIFER KLUND, AIA, ACHA, AND AMY DOUMA, AIA, LEED AP

T

he many challenges facing health care institutions are intensified when hospitals are located in rural areas. Ever-tightening budgets, aging facilities, shifting demographics, and the rapid evolution of technologies are among the concerns hospital administrators are working to address. For Critical Access Hospitals (CAH), these concerns are compounded by additional uncertainties; rumors of potential revisions to the CAH program abound, which could mean changes in reimbursement, staffing, and service delivery. All of these issues could have significant impact on the future of rural health care delivery, creating an environment of uncertainty for system administrators and the communities they serve.

Many rural facilities require upgrades now, however administrators simply cannot wait until the future of health care becomes clear in order to address pressing needs. Despite an uncertain environment that may last years—or even decades—rural health care systems must continue to provide the best in care, staffing, and support to the diverse populations they serve. Given ongoing financial challenges, many are searching for new approaches to deliver high-quality, cost-effective care.

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Read us online wherever you are!

Architectural innovation Our role as health care architects is to innovate the most practical and efficient solutions possible to support rural facilities and CAHs as they navigate an unknown future. While working with multiple health care providers across the country, we developed one solution: A universal “platform” of spaces that is adaptable, scalable, and flexible in order to meet changing and future needs, demographics, and care models.

One of our clients, CentraCare Health in Central Minnesota, has adopted this universal platform concept for new and renovated facilities. Our projects for CentraCare Health include a new 65,000-square-foot clinic and hospital in Long Prairie and a major hospital addition in Melrose, which will open this fall.

By employing the universal platform model, these projects reap both immediate and long-term benefits. In the short term, initial project costs were reduced by eliminating redundant space within departments. Long-term benefits include the ability to adapt the space—with minimal disruption or cost—to changes in volume, service lines, or community needs. This approach positions the facilities for success despite the uncertainties of rural health care by providing the flexibility to quickly adapt to changing demands.

Defining the universal platform In our CentraCare models, the universal platform isn’t a traditional department.

Instead, it’s a modular set of rooms that serve multiple departments, such as emergency, surgery, or diagnostic imaging. The rooms are designed to be flexible, so they can be used for more than one purpose throughout the day, and from day to day. The rooms are adaptable, and are flexible enough to accommodate new functions or service lines with minimal change. The platform itself, comprised of these flexible and adaptable rooms, is scalable, so it can be easily expanded should the need arise (see Figure 1).

On any given day, a room may be used for surgery or imaging prep and recovery during the day and transition to emergency or urgent care as that volume grows in the evening. Rooms could also be used for chemotherapy, infusion, pain management, or pre-surgical consultation. The rooms may include a recliner instead of a bed; a flexible headwall system for gases and technology; and multi-function lighting to accommodate various purposes.

Mobile carts equipped for different care needs can be moved easily in and out of rooms. To provide an aesthetic appropriate to everything from an emergency visit to a physician consult, warm, tactile finishes and artwork are incorporated into the design.

The universal platform’s premise is that its co-located rooms are designed to accommodate a variety of uses to minimize duplication of space, and to adapt to different functions if necessary with minimal cost and disruption.

Involving the staff during design phases Many top-level health care facility administrators welcome the idea of the universal platform given its flexible use of space and its ability to adapt to future needs. To illustrate the concept, we provide interactive models that demonstrate how the platform’s use evolves over time. We describe how the universal platform eliminates redundant, under-utilized space; re-supports operational and patientcare efficiencies; and, therefore, lowers operating and building costs.

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NOVEMBER 2017 MINNESOTA PHYSICIAN

At the same time, this planning approach asks facilities to retool their operational strategies. Because these rooms serve multiple functions and often require cross-coverage from staff in other departments, additional staff training may be required to meet patients’ care needs. Staff also might begin worrying about whether the platform’s increased efficiencies will result in fewer jobs with greater work expectations and stresses.

For these reasons, incorporating staff input during the design and construction processes—from inception through completion—is critical to securing their understanding and buy-in. Because they will be working within the platform, their insights into space organization and flow, efficiencies and equipment, furnishings and finishes are crucial to the approach’s success. If they’re part of generating the original design concepts, and can help shape the operational details of the platform, they’re much more supportive of the approach.

The core mission of CAHs and other rural health care facilities is bringing high-quality, sustainable care to the people in their communities. The universal platform concept empowers facilities to “do more with less” by creating flexible spaces that can be used by multiple departments, enabling higher utilization of each space and reducing overall space requirements. As a result, initial construction costs are reduced— but the greatest savings are seen in year-over-year operating costs. Savings here ensures that scarce The greatest savings are seen in funding can be directed where it belongs—toward year-over-year operating costs. the care of the patients.

During our design sessions and informational meetings with staff, we also describe how the platform’s co-located rooms mean less walking for them, improved care for patients, and greater cost savings for the facility. It’s important to discuss how the universal platform introduces changes that benefit everyone. At the same time, administrators should create leadership committees and cross-department user groups to collaborate on the platform’s design and operational plan.

The goal is to circulate ideas and elicit discussions in a way that leverages the insight of all, especially “front-line” staff. As a result, they are more willing to carry the charge forward and help promote the platform’s innovations. In addition, they will be responsible for its successful implementation once the facility opens, so it is essential that they understand and embrace the associated operational concepts. For most staff, this is an exciting opportunity to reshape health care delivery; they understand that health care is changing and want to be part of the process.

INPATIENT

INPATIENT SUPPORT

UNIVERSAL PLATFORM

Long-term benefit

SURGERY

In addition, the potential adaptability and scalability of these spaces positions facilities for success as health care services and delivery models evolve. It is often said that—within the world of rural health care facilities—“change is the only constant.”

The universal platform concept reduces the disruption associated with change and enables facilities to respond quickly to the demands of an uncertain future.

Jennifer Klund, AIA, ACHA, is a health care principal at HGA and has more than 20 years of experience in medical planning and design.

Amy Douma, AIA, LEED AP, is a design principal at HGA specializing in health care.

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23

SPECIAL FOCUS: RURAL HEALTH

The rural Minnesota clinician workforce Retention, then recruitment

BY KEVIN GISH, MHA, LNHA, AND CHARLES WINJUM, MD

multi-pronged approach toward not only maintaining, but actually growing our medical staff during these uncertain and difficult times.

ne doesn’t have to search far or long to validate what we all feel and know when it comes to the disequilibrium between the supply of and demand for physicians in the U.S. As a clinic or hospital in a rural area, the problem is exacerbated by the perhaps over-generalized situation where physicians prefer to practice in larger cities and larger facilities, while rural American (and certainly rural Minnesota) communities age disproportionately faster than our urban or suburban counterparts. The increased availability and presence of advanced practice clinicians (APC: certified nurse practitioners and physician assistants), especially in primary care, offers some relief.

However, there are regulatory requirements and certainly medical needs for ongoing physician presence even in these remote communities. So, what is a local health care team to do? How do you successfully and sufficiently staff a rural hospital and clinic, especially when it comes to primary care?

The situation in Fosston

O

First off, there is no one easy answer. If someone out there has the secret solution to rural health care clinician recruitment success, we’ve not heard of it. In the absence of an easy solution, we here in Fosston have taken a

Healthcare Planning and Design

Before we tell you about the “what” and the “how,” we’d like to preface our story with the “why,” by describing our situation at Essentia Health Fosston. In the summer of 2015, we came to grips with the fact that about half of our medical staff (physicians and APCs) were either 60 years old or fast approaching that seemingly threshold age. We had a millennial female physician join us straight out of residency, but she was effectively replacing a physician who was in the process of leaving us after a relatively short tenure. The most seasoned and busiest APC in our clinic had gone on extended medical leave and prospects for her return were grim. She did not return to practice. At this point, unfortunately, our story sounds too familiar to other rural communities.

What could we do? The first and perhaps most obvious decision we made was that it was quite unlikely that we could recruit our way out of this situation. Recruitment would have to be part of the solution and the ultimate goal, but initial efforts had to be aimed at retention. We quickly evolved from an organization that put hard-and-fast requirements on clinicians (e.g., you will work in the ER, you will live in town, you will take call) to softening those stances and being more flexible organizationally when we could feasibly do so. The result of that epiphany was an impact not only for our clinicians nearing classic (Medicare) retirement age, but also for new clinicians being recruited and onboarded.

Retaining senior staff first Our initial focus was on our senior staff members. We found, not surprisingly, that the level of engagement on the part of the clinician is directly proportional to a desire to extend his/her practice beyond what may have been previously determined as a retirement age. One of our long-term and quite busy clinicians retired a bit earlier than expected (and earlier than she wanted), and has since left the community. On the other hand, our senior physician on staff has been slowing down over the last three years. He initially reduced his clinic practice by one day per week, then phased out of providing ER coverage, and has since reduced his practice by another day per week. And, as the local health care leaders, we couldn’t be happier! He continues to round on his patients in the hospital, continues as the medical director of our skilled nursing facility, and is a tremendous “medical mentor” to our younger medical staff members.

Essentia Health Plastics and Skin Renewal Center; Duluth, MN

Duluth, MN | 218.727.8446 Minneapolis, MN | 612.338.2029 Cambridge, MN | 763.689.4042 Superior, WI | 715.392.2902

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NOVEMBER 2017 MINNESOTA PHYSICIAN

The topic of “engagement,” as we use the term, perhaps needs more explanation. Like many of you, we are part of an integrated health care system; many clinics and several hospitals across a few states. Clinician engagement doesn’t necessarily (though it can) mean buying into everything that the larger organization feels are priorities and preferred practices. The Just Culture term “imposer” comes to mind here. Rather, we find that the more impactful level of engagement is the clinician’s loyalty to their practice (patients), partners, and community. Do we want our cake and eat it too? Absolutely! While we work with our senior clinicians on a “slower path” to retirement, we simultaneously work with our younger clinicians on openness toward being a functioning part of the larger organization.

good prospective candidate. These can be effective methods, but can also be a bit of a shotgun approach. Here in Fosston, we’ve come to another somewhat obvious conclusion; people from small, rural communities Senior staff as mentors don’t have to be sold on living in small, rural communities. We were both As stated earlier, retention is necessary but without combining recruitment, we born and raised in small, rural Minnesota communities, and some of our are merely slowing our descent. However, recruitment clinicians (physicians and APCs) share a similar without retention is probably equally futile. We have story. So, it is important for us to seek candidates found it to be universally true that having senior by “looking rural.” Consider working with schools clinicians as mentors is a determining factor for new such as the University of Minnesota Duluth’s clinicians applying to join us. The mere presence of Medical School, which focuses on primary care An engaged medical staff senior clinicians, however, will not suffice. Those and rural medicine. See if you can arrange for a during the interview process clinicians need to be engaged such that they will current medical staff member to guest lecture is of utmost importance. mentor and advise, console and comfort, and maybe and maybe even precept with the family practice even push a little to get their successors up to speed. residency program. Take on an RPAP (Rural Physician Associate Program) student or for less How to recruit candidates of a commitment, a SIM (Summer Internship in It’s very important that recruiting involve all of the Medicine) or Rural Medical Scholars Program medical staff, administrative leadership, and the student. Or you could find a candidate in smaller ways by engaging your broader community. But before you can wow a prospective candidate with whole team and community to identify sons, daughters, nieces, nephews, your engaged and positive medical staff and leadership team, your wonderful second-cousins, family friends, and acquaintances who are either in or facility, and supportive community, you first need to find that potential may be interested in attending medical school and may, by virtue of a rural candidate. The answer to, “How do I go about finding a candidate?” is best upbringing, be inclined to consider practicing in a rural area. posed as another question, “How many ways can I approach this?”

Are we being inconsistent? Yes. Is this necessary? Yes. Are we transparent in these approaches? Yes.

We’ve probably all communicated our clinician needs via expensive print or online listings in periodicals or sites frequented by clinicians looking for work, or maybe you’ve printed postcards and sent them out by the hundreds hoping a couple (or maybe even just one) will resonate with a

We have found that starting discussions about recruiting early (when you aren’t desperate) is a far better approach. Creativity is key, whether The rural Minnesota clinician workforce to page 424

Contact DMS Health: 800.437.4628 sales@dmshealth.com www.dmshealth.com

MINNESOTA PHYSICIAN NOVEMBER 2017

25

SPECIAL FOCUS: RURAL HEALTH

Precision medicine in rural Minnesota What does it look like?

BY PAULA M. TERMUHLEN MD, FACS, AND RUTH WESTRA, DO, MPH

A

28-year-old woman presents to your office in Ely with a lump in her left breast. One week later after mammograms, ultrasounds, and biopsies, you call her with the results to let her know that she has breast cancer. She shares with you that her paternal grandmother and two paternal aunts had breast cancer. In preparation for her meeting with the surgeon in Duluth, you think she needs genetic testing to help her make decisions about treatment. Now what do you do?

In 2017, patients like the one in this case study require a personalized approach to determine how to move forward with treatment and prevention of future breast cancers. Understanding her personal cancer risk and the future risk of her biologic relatives is what precision medicine is designed to do. As noted in the July 2017 Minnesota Physician report of the April 2017 Minnesota Health Care Roundtable, precision medicine includes the P4 Medicine with care initiative that is personalized, predictive, preventive, and participatory. The hope is that with the advancement of precision medicine we can increase success in patient care. In Minnesota, we are fortunate to have a solid base of primary care physicians who strive to

provide individualized care. Is there a difference between precision medicine in rural Minnesota compared to urban Minnesota? The National Institutes of Health advocate that the health of patients is dependent not only on their individualized diseases but also on biological, social, environmental, and economic determinants. Rural populations have similar yet different social determinants of health from urban populations and population health also needs to be evaluated. Thus, rural precision medicine will offer the same benefits as the urban version, but will have to take rural concerns into account in order to make it successful.

Focusing on evidence-based research The concerns of education, cost, and access need further clarification in order to proceed with a more defined sense of what it takes to provide rural precision medicine. As we aim to have more clarity with diagnostic tools and therapies for individual care regardless of the geographic location of patients, concentrating on evidence-based research will be important to ensure that we provide carefully vetted cost-effective care. Precision medicine includes testing newbornsâ&#x20AC;&#x2122; genetic makeup for appropriate treatments; finding diseases earlier by analyzing biobank samples; making more precise diagnosis of traumatic brain injuries, and on a genetic level improving the diagnosis of lung cancer using improved imaging techniques; and identifying effective pharmacologic agents based on the genetic signature of a tumor.

Precision medicine initiatives have developed along two pathways: 1) a focus on cancer including improved tools for diagnosis and targeted treatment strategies, and 2) improved knowledge of diagnosis and treatment of a variety of other health conditions and diseases. Both of these aims directly apply to the health of patients in rural Minnesota. Imagine how care can be streamlined for patients when a rapid and accurate assessment of their health risks and specific therapeutic interventions are easily identified. As noted by Drs. Collins and Varmus in the New England Journal of Medicine in 2015, research into pharmacogenomics will ensure the right drug for the right patient at the right dose at the right time. This type of strategic application of therapeutics can help our patients receive state-of-the-art care in a cost-effective model that minimizes risk from side effects. Identifying priorities as we spend health dollars on clinical care may not get us the outcomes we desire unless we also address social disparities. The importance of population health and rural education, access, and cost must be taken into account in order to successfully host precision medicine in rural areas.

Education Precision medicine also impacts other health professionals besides physicians.

For example, with the explosion of information from pharmacogenomics, patients and physicians will need access to rural pharmacists who can support this type of medication management. Thus, continued education for rural pharmacists will be crucial as we develop new strategies for personalized care. A diversified and educated health care workforce is necessary to fully realize the benefits of precision medicine.

Patient education Patients and providers need to be aware of the ever-changing landscape concerning precision medicine. Both may have concerns regarding privacy,

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NOVEMBER 2017 MINNESOTA PHYSICIAN

and at a deeper level, the ethics of knowing about the risks and then acting on that information. Thus, patient education is critical. Should all patients be offered precision medicine or is it only for patients with a more complicated diagnosis? It is crucial for knowledgeable health care personnel to develop care planning for patients who will benefit the most. We must be diligent about capturing documentation and sharing it appropriately among providers and with patients.

Ensuring access

How do we ensure access to the appropriate testing and precise therapeutics for all patients in rural Minnesota? Much of the access relies on our integrated health systems, but we cannot forget independent physician groups and critical access hospitals. Navigating the challenges of geography and dealing with a limited workforce are barriers in rural care that must be overcome.

Genetic testing typically requires a referral for Physician education genetic counseling prior to ordering specialized Physicians need additional training to increase their tests. The genetic counselor is a key member of Social determinants of understanding of genetics and improved diagnostic the team who makes a determination regarding health are intertwined testing in order to advance the P4 Medicine Initiative appropriate testing and counsels patients about with precision medicine. and bring precision medicine to each practice. risks and surveillance. There are, however, a Physicians also need to learn more about population limited number of genetic counselors and most are health and its interplay with precision medicine. It found in larger population centers. This may be an is important that continuing medical education opportunity to develop telecounseling services in opportunities be accessible to rural physicians. partnership with local providers to allow patients to receive the benefits of precision medicine closer to home.

As we develop new strategies for health care and further understand the biological complexity of health, a prepared health care provider The advantages of understanding oneâ&#x20AC;&#x2122;s personal risk for disease can workforce will be able to help patients navigate the future of precision help providers make smart choices with patients regarding their health. medicine. With an increased understanding of complex disease processes, It also has the tangible benefit of streamlining testing to those who truly we must assist our patients to fully understand complex information, need it. This will allow a targeted approach to prevention and maintenance make choices to improve their health, and be active participants in their of health. With this knowledge, priorities for services in rural areas can care. Increasing our communication footprint through the use of social be enhanced and the burden of travel for care reduced to only those who media, mobile devices, and telehealth will assist rural Minnesotans advance precision medicine.

Precision medicine in rural Minnesota to page 404

OVER PROCESSING

OVER PRODUCTION

PATIENT MOVEMENT

WORKER MOTION

INVENTORY

8 FORMS OF WASTE IN HEALTHCARE

WAITING

CORRECTION OF DEFECTS

WASTED STAFF SKILLS

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BUSINESS EXCELLENCE

www.eapc.net MINNESOTA PHYSICIAN NOVEMBER 2017

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SPECIAL FOCUS: RURAL HEALTH

Workplace violence in a medical center Assessing your preparedness

BY STACY BARSTAD

L

behavioral health patients, a disgruntled employee, a patient upset about a bill, or a frustrated patient in pain with irritated family members.

ike most Minnesota towns, Tracy is a safe community. Everyone knows everyone. There are, however, drug users and meth abusers like in many rural communities. Does a medical center have to worry about violence in their health care center where people come for comfort, to develop trusting relationships, and to heal?

Tracy is located in the rural southwest corner of Minnesota with a population of 2,500 people. It is considered to be a relatively safe community with the typical demographics found in many rural areas.

Sanford Tracy Medical Center is a 25-bed critical access hospital with an attached rural health clinic and an emergency room. The facility serves a variety of patients, but treats a large population of geriatric patients, which is not uncommon in many rural communities. Sanford Tracy has 90 employees, including two doctors and four APPs with outpatient behavioral health embedded in the primary clinic serviced by two LICSWs and a nurse practitioner.

Workplace violence at a health care facility can quickly escalate and pose a threat to staff because of people seeking narcotics, agitated

ENGAN ASSOCIATES

Creating Healing Environments for 38 Years

After Minnesota implemented the Violence Against Health Care Workers Law in 2016, all Minnesota hospitals were required to develop a plan and policy to assess potential risks and prevent violence to staff, patients, and visitors. Sanford Tracy was no exception to this law, and our staff dug in to assess the potential risks that could put our staff and patients in a harmful situation.

Assessing the risks We formed a committee that included staff from a wide range of departments such as administration, maintenance, clinic and hospital nursing, behavioral health, reception, and medical staff. Going through a gap analysis, staff had their eyes opened to risks no one had even thought of before. Opportunities to tighten up and put prevention efforts in place were examined and acted on. Some of the safety concerns included: 1) narcotics on site with a 24/7 emergency department; 2) a local pharmacy that closes at 5 p.m.; 3) a large population of non-English speakers who could become frustrated and fearful due to language barriers; 4) no 24-hour in-house security; 5) a staff that is 95 percent female; 6) a limited number of staff on during evening and night shifts; 7) lack of employee knowledge on how to de-escalate and handle violent situations and protect themselves; 8) outdated policies and procedures; 9) inadequate parking lot and entrance lighting; 10) only one exit in the emergency room; 11) potentially unsafe nighttime employee parking; 12) inadequate after-hour entry locks; and 13) multiple points of entry.

The task now was to put a plan of action in place to keep our facility, patients, and staff safe.

Considering costs Like other rural facilities, money is sacred, and the list of improvements and “fixes” required that money be spent. Our staff looked for grant funds to make our opportunities happen. Three grants were received from the state of Minnesota including a Rural Flex Grant, a Minnesota Hospital Association grant, and a Capital Improvement Grant. These funds were then used in conjunction with matching funds from the facility to enhance door security, replace a nurse call system that included panic buttons for the staff, and train high-risk front-line employees who could find themselves in a dangerous situation.

De-escalating and assessing violence

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A very important investment that Sanford Tracy made was MOAB training for staff members who could potentially find themselves in vulnerable situations. This training taught staff to recognize and manage aggressive patient behavior and how to communicate verbally and nonverbally. Knowing how to de-escalate aggressive patient behavior before a situation worsens is an important skill to learn, as well as what to do in a situation where someone felt threatened by a patient.

An important tool to help front-line nurses manage patients is the Brøset Violence Checklist, which is embedded in the EMR. Staff can use

it to objectively assess patient behavior and use suggested interventions to control a patient’s behavior. Each patient, no matter whether they are perceived to be a risk or not, is screened by the nursing staff so a baseline risk is documented. The interventions are a way to de-escalate or prevent any at-risk behavior from escalating.

Extra security measures

environments, role played through possible scenarios, and did a deep dive risk gap analysis and everyone on staff played a part. By preventing violence before it happens and learning how to deal with it before and if it erupts, we have met the law’s requirements head on and protected our staff in case of an unfortunate event.

Workplace violence at

Door security was enhanced by adding aftera health care facility hour keypads with unique codes for each can quickly escalate. employee. We also added a two-way intercom system at several key points of entry that connected to the nurses’ station for both staff and visitors to use. Having people identify themselves after hours in order to enter made staff feel more comfortable knowing who had come into the facility.

Lighting was improved in the parking lots and revamped parking policies for evening and night shifts were put in place. Night staff was allowed to park closer to the facility to prevent them from walking through a dark parking lot. We set a standard after-hours lock down time, which eliminated people wandering in and out of the facility with only two to three nurses in-house. Now everyone knows what time the main entrance is secured. Since we are a small community, we debated about locking the doors because we wanted visitors to feel welcome when they came to see their loved ones. However, after weighing the risks, we agreed that it was best to lock the doors at 5 p.m. when the majority of staff left for the day. This way the evening shift wouldn’t encounter unauthorized people wandering around the halls.

Panic buttons for the nursing staff were part of the new patient call system installation. These buttons are on staff badges and allow a staff member to alert others if they are in an unsafe situation. For example, if a nurse is with a patient in the ER who poses a threat, that nurse can quickly alert others to come to the ER to help her. Before we installed this system, there was no way short of screaming to call for help.

Stacy Barstad is CEO of Sanford Tracy and Westbrook Medical Centers.

Party Fabulous!

Holiday Events at

To prepare for a major security threat at Sanford Tracy, it was important to be on the same page as local law enforcement. So we ran simulated and tabletop drills with local law enforcement to teach staff how to react and familiarize law enforcement with the layout of our facility firsthand. This way if they were called to a major event here, they were ready and so was our staff.

Maintaining our commitment to safety The initial committee that we formed meets annually to go over the policy and process, and review any facility improvements that should be addressed. Staff is required to complete annual mandatory education on workplace violence and what to do if violence occurs. All new hires receive violence training as well. Keeping staff engaged and aware of potential situations is a key to safety and protection.

Often we take for granted, and assume that rural areas are safe.

However, this can be quite the opposite. Small medical facilities can be very vulnerable because of limited staffing, limited or no security coverage, and narcotic availability. Protecting our facility from acts of violence ranging from an irate patient, employee, or visitor was an important and eye-opening process. By going through the action of securing our facility and training our employees we are prepared to deal with threatening situations. We worked hard to assess our work

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MINNESOTA PHYSICIAN NOVEMBER 2017

29

PUBLIC HEALTH

Minnesota Medical Cannabis Program First year patient experiences

BY TOM ARNESON, MD, MPH

I

n May 2014, Minnesota became the 22nd state to create a medical cannabis program. Distribution of extracted cannabis products in liquid or oil form to qualified, enrolled patients began July 1, 2015. Minnesota’s medical cannabis program is distinct from those in nearly all other states as the Minnesota Department of Health’s Office of Medical Cannabis (OMC) collects and analyzes data to learn from the experience of program participants. This past summer OMC published a report drawing on data from enrollment, purchasing, symptom and side effect information, and survey results, describing the experience of patients who enrolled during the first year of the program’s operation. This article presents highlights from that report, which can be viewed in its entirety at http://www.health.state. mn.us/topics/cannabis/about/firstyearreport.html.

Participation Between July 1, 2015 and June 30, 2016 a total of 1,660 patients enrolled in the program and 577 health care practitioners registered themselves for the program. The most common qualifying conditions were severe and persistent muscle spasms (43 percent), cancer (28 percent), and seizures (20

percent). Each of the remaining six qualifying conditions during the first year—Crohn’s Disease, terminal illness, HIV/AIDS, Tourette syndrome, glaucoma, and ALS—accounted for less than 10 percent of patients. Ten percent (167 patients) were certified for more than one qualifying condition.

Most patients were middle-aged (56 percent between ages 36–64), 11 percent were <18, and 11 percent were ≥65. Distribution by race/ethnicity generally matched the state’s demographics, with 90 percent of patients describing themselves as white.

The legislation that established the program specified there would be one location for purchasing medical cannabis (called Cannabis Patient Centers [CPCs]) in each of the state’s eight congressional districts. Patients who enrolled in the program during the first year came from throughout the state, with the average distance from the patient’s home to the nearest CPC 20 miles (median = 16 miles). Some patients were a considerable distance from the nearest CPC, however, with 13 percent over 60 miles to the nearest one. The program allows patients to have one or more parents or non-parent caregivers who register with the program who are then allowed to transport and administer a patient’s medical cannabis. Only 11 percent of patients had a registered caregiver, 17 percent had a registered parent or legal guardian, and 26 percent had either a registered parent/guardian or a registered caregiver.

Among the 577 health care practitioners who registered with the program, 82 percent were physicians, 13 percent were advanced practice registered nurses, and 5 percent were physician assistants.

Medical cannabis use patterns

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NOVEMBER 2017 MINNESOTA PHYSICIAN

Each patient’s medical cannabis purchasing transactions during their first enrollment year (or through early March 2017 if still within their first enrollment year) were analyzed. A total of 16,238 products were purchased during 10,898 transactions, with 38 percent of all transactions consisting of two or more products. For analytic purposes, products were classified according to the ratio of delta-9-tetrahydrocannabinol (THC) to cannabidiol (CBD) as follows: • Very High THC:CBD (100:1 or higher) • High THC:CBD (>4:1 up to 99:1) • Balanced THC:CBD (1:1 up to 4:1) • High CBD:THC (≥1:1 up to 100:1) • Very High CBD:TCH (100:1 or higher) Products for enteral administration (swallowed—includes capsules and oral solutions) and products for inhalation (vaporized oil) each accounted for 45 percent of product purchases. Products for oromucosal administration (absorption through the cheek) accounted for 9 percent. Nearly 50 percent of all purchases were Very High THC:CBD products, followed by Balanced THC:CBD (30 percent), and High CBD:THC (15 percent). Very High THC:CBD products were most commonly oil for vaporization or for oromucosal absorption, while Balanced THC:CBD and High CBD:THC products were most often for enteral administration.

Benefits Information on patient benefits comes from the Patient Self-Evaluations (PSE) completed by patients prior to each medical cannabis purchase and from patient and health care practitioner surveys. Analysis of PSE and survey data indicate perceptions of a high degree of benefit for most patients.

Benefit scores

they started using medical cannabis, 29 percent reported ≥30 percent reduction of pain and 12 percent both achieved that level of reduction and retained it, on average, for at least four months.

• Among patients with Crohn’s Disease, 51 percent reported ≥30 percent reduction in the number of liquid stools per day and 29 percent both achieved that level of reduction and retained it, on average, for at least four months.

Patients responded to a survey question asking • Among patients with Tourette syndrome, 61 Analysis of PSE and survey them how much benefit they believe they received percent reported ≥30 percent reduction in tic data indicate perceptions of from using medical cannabis on a scale from 1 frequency and 46 percent both achieved that a high degree of benefit (no benefit) to 7 (great deal of benefit). Across all level of reduction and retained it, on average, for most patients. patients, 64 percent indicated a benefit rating of for at least four months.

6 or 7 and this degree of benefit was indicated by at least half of the patients with each medical Side effects condition. A small but important proportion of Approximately 20–25 percent of enrolled patients patients indicated little or no benefit: 9 percent reported negative physical or mental side effects gave a rating of 1, 2, or 3. Benefit ratings varied somewhat by qualifying of some kind, with the majority—around 60 percent—reporting only medical condition. When patients were asked what the most important one and 90 percent reporting three or fewer. The vast majority of adverse benefit was for them, two-thirds indicated a reduction in symptoms side effects—around 90 percent—were mild to moderate in severity. directly related to their qualifying medical condition and most of the An assessment of the 30 patients reporting severe side effects, meaning remainder indicated a more general quality-of-life benefit. Health care “interrupts usual daily activities,” found no apparent pattern of patient age, practitioners were somewhat more conservative in assessment of benefit medical condition, or type of medical cannabis used. The most common to their patients. Across all the benefit ratings by health care practitioners, adverse side effects were dry mouth, drowsiness, and fatigue. During the 38 percent indicated a rating of 6 or 7 and 23 percent indicated little or no benefit (rating of 1, 2, or 3). Descriptive comments suggest at least part Minnesota Medical Cannabis Program to page 384 of the difference is driven by the perspective of what constitutes benefit.

The patients cite quality-of-life benefits more often than the health care practitioners, who appear to focus more on objective measures, such as seizure counts.

Symptom scores The symptom scores provided in the Patient Self-Evaluation data have the advantage of completeness, since they are required prior to each medical cannabis purchase. In this report, a reduction of ≥30 percent was applied to most symptoms to indicate clinically meaningful symptom reduction.

For most symptoms between half and two-thirds of patients who achieved clinically meaningful improvement retained that degree of improvement over the subsequent four months.

Examples of proportion of patients achieving and retaining ≥30 percent symptom reduction include: • Among patients with severe, persistent muscle spasms, 48 percent reported a ≥30 percent reduction in spasm frequency and 28 percent both achieved that level of reduction and retained it, on average, for at least four months.

• Among seizure patients, 68 percent reported ≥30 percent reduction in seizure frequency and 49 percent both achieved that level of reduction and retained it, on average, for at least four months.

• Among cancer patients with at least moderate levels of nausea when they started using medical cannabis, 38 percent reported ≥30 percent reduction of nausea and 23 percent both achieved that level of reduction and retained it, on average, for at least four months.

• Among cancer patients with at least moderate levels of pain when MINNESOTA PHYSICIAN NOVEMBER 2017

31

REGENERATIVE MEDICINE

Breakthrough T cell therapies Commercialization requires additional innovation

BY JEFF LITER

T

cell therapies such as CAR-T (chimeric antigen receptor) are moving from clinical trials to approved new drug therapies.

Recently, Novartis went before the FDA to present data for CTL019, a CAR-T treatment for pediatric acute lymphoblastic leukemia (ALL). The panel voted unanimously 10–0 in favor of recommending the treatment. “I think this is the most exciting thing I’ve seen in my lifetime,” Dr. Tim Cripe, an oncologist on the panel said while explaining his vote. Many of these clinical trials using “CARs” to treat blood-borne cancers are reporting response rates in the 80 percent range, with the cancer cells being completely eradicated. Other organizations with various CAR-T therapies in Phase III clinical trials are expected to receive similar approvals from the FDA in the latter part of 2017.

Modifying the cells

Telephone Equipment Distribution (TED) Program

CAR-T treatments involve taking a person’s own T cells, removing them (referred to as ex vivo) so they can be genetically modified, then putting them back into the body where those cells now have the ability to detect and kill cancer cells, eradicating them from the body. This

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NOVEMBER 2017 MINNESOTA PHYSICIAN

process is referred to as autologous or patient specific drug/product.

There are two very broad approaches known as virus-based methods and non-viral methods. Reported costs to provide virus-based therapy are in the $300,000 to $350,000 range. Research completed by B-MoGen indicates that the cost of the genetic modification portion of creating this patient specific drug/product is in the range of $38,000 to $45,000.

Additionally, the current methods of genetic engineering using virusbased methods have challenges other than cost that make the process overly complex, give rise to lot-to-lot variability of the product, and have a safety profile that is not ideal.

Virus-based methods One might ask why virus-based methods are used given these issues and if there are better alternatives? Today’s tool sets for genetically modifying cells come in many flavors. T cells being modified in these therapies to date have been more amenable to modification using the virus-based method. As of this publication, there is only one company not using a virus-based method to modify T cells. The virus-based method will typically have yields of 52 percent to 60 percent of the cells being genetically modified during the ex vivo engineering process. This high percentage of modification at the starting point of cell expansion is important in meeting the release criteria of the patient drug/product.

Typically, the starting point of viable and healthy T cells in patients with these types of cancers is diminished due to their immune systems already being overtaxed from the cancer. A portion of the release criteria involves a minimum number of cells (in the billions) that have been genetically modified and with a certain viability percentage of those cells. Hence, the more cells modified at the beginning, prior to their expansion phase, will result in a much higher cell count of the desired cells in the final patient drug/product.

As mentioned briefly earlier, the virus-based method of modification does not come without costs: • Complexity of manufacturing: Virus-based approaches require added protection mechanisms that need to be in place to avoid cross contamination of the cells when the patient drug/product is being manufactured. These viruses are highly air-borne and contagious. Therefore, costly clean room HVAC systems must be in place to ensure that there is no air leakage from one manufacturing suite to another.

• Time-to-market: Initial designs of a CAR under a virus-based approach requires a complex packaging encapsulation for the virus and the cargo. The process for a new CAR therapy is nine to 12 months and costs $750,000 to $1,000,000. See Figure 1 to understand the complexity of making the lentil-viral vector as opposed to a non-viral based method.

• Lot-to-lot variability: Virus-based reagents produced for genetic engineering have been known to have inconsistencies with lotto-lot variability. In some cases, clinical trials have had to go on pause due to the unavailability of the virus-based reagents.

Viral packaging vectors

Lentivirus

LV step 1: Clone construct

LV step 2: Package virus

LV step 3: Titer/QC Virus

LV step 4: Transduce

Sleeping beauty

Sleeping Beauty

Cargo SB step 1: Clone construct

SB step 2: Save time and money

SB step 3: Transfect

Figure 1. Virus-based processing steps vs. non-­virus based processing steps.

Breakthrough T cell therapies to page 364

Source: B-­MoGen Biotechnologies 7-­2017

CELEBRATE THE HOLIDAYS WITH THE SPCO

Join in an annual holiday tradition as the SPCO presents festive performances of some of classical music’s most treasured works. These performances sell out every year — order today to ensure you get seats!

Bach’s Brandenburg Concertos Thursday, December 7, 7:30pm Temple Israel, Minneapolis Friday, December 8, 8:00pm Saturday, December 9, 8:00pm Ordway Concert Hall, Saint Paul Sunday, December 10, 2:00pm Benson Great Hall, Arden Hills

Led by SPCO musicians and soloists Continuing our annual holiday tradition, the SPCO presents Bach’s most cherished set of orchestral works, the Brandenburg Concertos. The profound inventiveness and instrumental virtuosity of these enduring Baroque masterpieces are on full display as led by our own SPCO musicians and soloists.

Please note: Holiday concerts are not eligible for voucher or concert membership redemption.

Handel’s Messiah

Copresented with The Basilica of Saint Mary

Thursday, December 14, 7:30pm Friday, December 15, 8:00pm The Basilica of Saint Mary, Minneapolis Saturday, December 16, 8:00pm Sunday, December 17, 2:00pm Ordway Concert Hall, Saint Paul Jonathan Cohen, conductor; Amanda Forsythe, soprano John Holiday, countertenor; Isaiah Bell, tenor; William Berger, baritone The Singers – Minnesota Choral Artists; Matthew Culloton, Artistic Director Celebrate one of classical music’s most beloved traditions as the SPCO performs Handel’s Messiah. Artistic Partner Jonathan Cohen and the SPCO are joined by an all-star roster of vocal soloists with the renowned vocal ensemble The Singers — Minnesota Choral Artists in their SPCO debut.

Adult Tickets: $11 – $50 | Child Tickets: $5 MINNESOTA PHYSICIAN NOVEMBER 2017

33

E-HEALTH

Intellectual or developmental disabilities Using e-technology to broaden the care team

BY GEORGE KLAUSER

I

n 2001, improving the quality of health care for people with intellectual or developmental disabilities became a national priority with the Surgeon General’s publication of “Closing the Gap: A National Blueprint to Improve the Health of Persons with Mental Retardation.” But progress to narrow the gap has been slow, with persistent inequities in health status experienced by people with intellectual or developmental disabilities (IDD).

As people are living longer, the health needs of people with disabilities, particularly in residential care settings, are becoming more acute. Age-related issues complicate their primary care and disabilities. While at risk for the same ailments and conditions as people in the general population, people with disabilities also are at specific risk for secondary conditions that can severely damage their health status and the quality of their lives.

This population requires a combination of medical and social services to live successfully and to participate fully in home-and-community-based settings.

People with disabilities face constraints in accessing much needed services such as employment and housing, as well as health and wellness. Various national and state statistics demonstrate a need to focus on this population.

For example, people with disabilities experience various health disparities.

According to DATA 2010, the largest set of U.S. health data, people with disabilities are more likely to have high blood pressure, be overweight, lack fitness activities and social emotional support, use tobacco, and lack regular medical tests. In addition, a significant portion of this population (30 percent) reported having poor health in the 2010 Minnesota Behavioral Risk Factor Surveillance System. Unless significant investments are made, these trends will continue.

An ACO to the rescue Systems of care must actively engage people with IDD in health awareness, self-advocacy, health literacy, and health promotion activities to enable them to participate in their own health care through improved access.

In 2013, a group of social services organizations came together to form the first such initiated Accountable Care Organization (ACO) in Minnesota.

The Altair Accountable Care Organization for People with Disabilities, with Lutheran Social Service of Minnesota as the fiscal and lead sponsor, came together to redesign disability services, creating a life-planning process that enables people with disabilities to make their own choices. This bold move included the creation of an e-health infrastructure that fully integrates primary care, behavioral health, and social services.

Today, the Altair ACO Includes: • Four behavioral health specialists (Bluestone Psychiatric Team; HealthStar Home Health; Fraser Mental Health; and Mount Olivet Rolling Acres [Crisis Care]).

• Seven disability service providers (Hammer Residences; Lifeworks; Living Well Disability Services; Lutheran Social Service of Minnesota; Mount Olivet Rolling Acres; Fraser; and Opportunity Partners).

• One primary care provider (Bluestone Physician Services).

• Two local public health departments (Stearns County and Dakota County Public Health).

Work. Life. Balance.

We’re looking for a Family Physician to join our provider team and help us continue a 60–year tradition of caring for our community at each life stage. You can change outcomes here. Relax your pace and balance your life in the beautiful Mille Lacs lake area.

Mission-driven contribution without large corporate complexities Time to focus on individual patients

Contact: Dr. Tom Bracken or Becky Fossand tbracken@mlhealth.org bfossand@mlhealth.org 320.532.2584 – mlhealth.org

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NOVEMBER 2017 MINNESOTA PHYSICIAN

Ultimately, this ACO aims to improve the quality of life for people with intellectual and developmental disabilities while simultaneously reducing costs. As Altair continues to expand its integrated delivery model, the findings and lessons for ACOs, expansion of health information exchanges, and treatment of people with disabilities can be applied throughout Minnesota and nationally.

The e-health infrastructure Today Altair members leverage a health information exchange (HIE) that is compatible across organizations and behavioral health providers that interfaces with Bluestone Physician Services’ Bluestone Bridge for health information technology and connects with a state-certified HIE provider, Simply Connect HIE. These ACO members work together to improve services and the health and quality of life for people with disabilities, while striving to reduce costs across the following sectors and services:

• • • • • •

Long-term care Social services Housing Employment Wellness Primary care

• Psychiatric care • Behavioral/mental health nursing and services • Alzheimer’s and dementia care • Home health care nursing • Respite care

in behavior to screen for depression, anxiety, isolation/loneliness, and dementia.

This, in combination with a planned quarterly conversation with the patient related to mental health, allows them to articulate their wishes, priorities, and offer the provider an opportunity to introduce interventions, or refer the patient to the proper Altair organization for support.

The Simply Connect Care Management application sends tailored, role-based alerts to a formalized care The target population of 7,200 people with team designed by the patient. For instance, should a intellectual/developmental disabilities strives to provide an patient’s employer report a change in behavior, adverse integrated onsite medical care, behavioral health services, reaction to a medication, or medical concern during and social services in the Metropolitan area of MinneapolisPeople with disabilities experience their work day, a notification is sent automatically to St. Paul, as well as in 87 counties across Minnesota. various health disparities. members of the care team. Within Altair this includes The e-health project is built on the outcomes of the residential service provider, the patient’s Special previous e-health efforts including: 1) the care/service Needs Basic Care (SNBC) Coordinator, County team is aware of the overall status and well-being of the Case Manager, and other members of the care team individuals supported in near real time; 2) the care team (pharmacist/physician/behavioral health specialist, and has the ability to proactively intervene or respond to an event in an appropriate informal supports) based on need or change in status. The SNBC coordinator in manner; 3) the care team has the ability to engage supports in a manner aligned with collaboration with other members of the care team are enabled to intervene and the care plan and wishes of the people supported on an individualized event-driven make the right intervention, in the right setting based on their assessment, goals, basis, in near real-time; and 4) Altair members can maximize investments in the and care plan. With real-time communication, collaboration supporting the new delivery model by giving the proper information to appropriate individuals. patient’s care plan, and a formalized care team a meaningful early intervention will support the patients goals and avoid unnecessary crisis care.

When setting out to achieve the goals, specficially creating an e-health infrastructure, Altair evaluated a number of HIE partners already operating in Minnesota. In evaluating potential partners only one was identified that understood the population, the goal of managing care in the community through home and community based services, and offered a model scalable for the various care and service providers engaged in Altair. Simply Connect HIE, a state-certified HIE, offers a unique solution able to meet requirements of care and service providers in all health care verticals. Simply Connect HIE also has the ability to connect to other state, regional, and national HIE’s to meet potential growth of the organization or model moving forward.

How it works The investment in a scalable e-health infrastructure has enabled provider organizations, including primary care, to gain more visibility into the patient’s total health and wellness. Simply Connect HIE allows patients to formalize a care team of a primary care physician, behavioral health provider, county case manager, care manager, family members and other formal and informal support systems. This enables patients to provide members of their care team access to a consolidated personal health record.

Members of the care team also receive and can respond to tailored and rolebased encounter alerts and interact with the patient in real-time. Using these real-time alerts, partners within the ACO can actively work to provide upstream interventions, reducing costs and improving patient outcomes.

The impact on primary care The IDD population has a high percentage of patients that have undiagnosed/ untreated “secondary” mental/behavioral health conditions, likely because any other behavioral health conditions can be attributed to their primary ID diagnosis. Without a clear understanding of the patients’ care plan and social history, proper intervention is unlikely, which increases crisis care utilization and staff ratios in the home and community-based setting.

Leveraging the HIE, primary care providers are now able to access a complete picture of their patient and have confidence in providing a more holistic assessment of the patient and intervention strategies. Within Altair, patients are assessed at service enrollment, annually, and after a noticed change

George Klauser was named executive director of Lutheran Social Service’s new Altair accountable care collaborative in 2013. The program applies compassionate redesign that offers people with disabilities a life-planning process where they make their own choices.

Sioux Falls VA HEALTH CARE SYSTEM

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

The VAHCS is currently recruiting for the following positions: Cardiologist

Psychiatrist

Urologist (part-time)

Endocrinologist

Psycologist

ENT (part-time)

Orthopedic Surgeon

Pulmonologist

apply online at www.USAJOBS.gov

(605) 333-6852 ·

www.siouxfalls.va.gov MINNESOTA PHYSICIAN NOVEMBER 2017

35

3Breakthrough T cell therapies from page 33

patient’s T cells with a CAR that will attack cancers have been used in a limited fashion thus far in the fight against cancer. The reason is two-fold. First, the efficiency of modification to the cells in reported literature is substantially less • Safety profile: Using a virus-based method gives rise to than 52 percent. To date, it is in the 10 percent to 15 insertional mutagenesis concerns that can percent range. Second, a primary non-viral genetic be minimized with a non-viral approach. modification method called the Sleeping Beauty • Cost to manufacture: As noted earlier, the DNA transposon system has been exclusively cost at a patient level for these virus-based licensed to a single entity, namely ZioPharm. approaches are in the range of $38,000 to “I think this is the most exciting ZioPharm is using this method in two clinical $45,000 per patient, accounting for over thing I’ve seen in my lifetime.” trials, which are still very early in the process. All 10 percent of the cost to manufacture the Dr. Tim Cripe of the other non-viral methods including the new, patient drug/product. exciting gene editing tool called CRISPR/Cas9 are still in very early-stage development to engineer T Non-viral methods cells and only a few are on the edge of being tried in Non-viral based methods for genetically modifying a clinical trials. All of these methods will ultimately need to overcome the gene delivery efficiencies if they are going to effectively compete against virus-based approaches.

Family Medicine Physician HealthPartners Medical Group – Hugo, Minnesota

We are actively recruiting a family medicine physician to join our primary care team at our Hugo clinic. This is a part-time or full-time, outpatient-only family medicine (no OB) position. Our primary care team includes family medicine physicians, pediatricians, advanced practice providers and chiropractic services.

This role offers potential for physician leadership and urgent care coverage at the clinic. We use the Epic medical record system in all of our primary care and specialty care clinics and admitting hospitals. Epic experience is helpful, but not required.

HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive salary and benefits package, paid malpractice and a commitment to providing exceptional patient-centered care. For more information, please contact diane.m.collins@ healthpartners.com or call Diane at 952-8835453; toll-free: 800-472-4695. Apply online at healthpartners.com/careers and search for Job ID 42519.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

healthpartners.com 36

NOVEMBER 2017 MINNESOTA PHYSICIAN

B-MoGen Biotechnologies has been steadfastly working on multiple non-viral approaches to overcome the gene delivery efficiency challenge, while at the same time, ensuring a good safety profile, simplifying the manufacturing process, and substantially bringing a lower cost solution to the marketplace. Currently, our company is pursuing three different approaches to this problem. As of this publication, we can report that one of our methods is well on its way to solving this problem. We have achieved gene delivery efficiencies greater than 15 percent in primary T cells. Additionally, we have several experiments that are being pursued to optimize this tool further. These experiments have had demonstrated success in other work and cell lines where the genetic engineering efficiencies have improved by substantial amounts. We are optimistic at this point that this additional optimization of our non-viral gene delivery platform will achieve comparable levels of genetic modification compared to virus-based solutions for T cells.

It is often said that necessity is the mother of invention. Historically, as products move toward mass adoption market forces have driven further cost reductions, product simplification, and improved design. B-MoGen is committed to leading this industry by bringing critical innovations forward for the manufacturing of T cell therapies by delivering a nonviral based genetic modification platform that is set to transform the way cancer is treated. We are confident that our non-viral platform solution will be able to not only achieve comparable gene delivery efficiencies, but also bring about simplified manufacturing processes, an improved safety profile of the patient drug/product, and a quicker time to market for new CAR designs.

Conclusion T cell therapies are revolutionizing the way cancers are treated and the stage has been set for them to move from clinical trials to serving all patients stricken with these deadly diseases. The market will demand that improvements be made to the manufacturing steps in order to help drive down the cost of delivery. B-MoGen is set to be a leader in helping this industry take the next steps toward even more effective therapies.

Jeff Liter is CEO of B-MoGen Biotechnologies.

A Place To Be Your Best.

Dr. Julie Benson, MN Academy Family Physician of the Year

The perfect match of career and lifestyle.

POSITIONS AVAILABLE:

OB GYN & FAMILY MEDICINE – Full-scope practice available (ER, OB, C-Section, Hospitalist, Clinic) • Independent/growing system • Located in the heart of lakes country, Staples, MN • Critical access hospital with 5 primary clinics and a senior living facility • 15 family medicine physicians and 16 advanced practice clinicians • Competitive salary, benefits, and sign-on bonus available Contact Michael Paul at 218.894.8633, or michaelpaul@lakewoodhealthsystem.com

ACMC Health is a physician-owned multispecialty health network in west central and southwestern Minnesota.

ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties: • Dermatology • ENT • Family Medicine • Gastroenterology • General Surgery • Geriatrician • Hospitalist

• Internal Medicine • Neurology • OB/GYN • Oncology • Ophthalmology • Orthopedic Surgery • Pediatrics

• Psychiatry • Psychology • Pulmonary/ Critical Care • Rheumatology • Urgent Care • Urology

Loan repayment assistance available.

FOR MORE INFORMATION:

Shana Zahrbock, Physician Recruitment shanaz@acmc.com | (320) 231-6353

www.acmc.com |

MASONIC CANCER CENTER A comprehensive cancer center designated by the National Cancer Institute

Medical Director, Minnesota Cancer Clinical Trials Network Masonic Cancer Center is seeking a physician with training and experience leading multi-center clinical trials in cancer to be the Medical Director of the newly formed Minnesota Cancer Clinical Trials Network (MNCCTN). The role is .5FTE. This individual will assume the leadership role in the implementation, conduct, and supervision of interventional (prevention, therapeutic, survivorship) clinical trials in new regional centers in the state of Minnesota. As Medical Director of the MNCCTN, the successful candidate will lead a new organization and direct clinicians involved in interventional cancer clinical trials to bring access to citizens in areas of the state with poor access to cancer clinical trials. Responsibilities include oversight of six (6) regional clinical trial sites (identification, feasibility assessment, and establishment); planning, implementation and execution of cost-effective and efficient clinical trial operations; working with the MNCCTN steering committee on vision, mission and direction of the network; representing the MNCCTN in discussions with other research partners across the state; and enrolling research subjects on prevention and therapeutic clinical trials. The Medical Director will partner with a full-time senior network manager who will lead the administrative operations of the MNCCTN. This position will work with the leadership of the Masonic Cancer Center, University of Minnesota, Mayo Clinic Cancer Center, and The Hormel Institute for efficient, shared trial support responsibility; and he/she will work with the Essentia NCI Community Oncology Research Program (NCORP), Sanford NCORP of the North Central Plains, and Metro Minnesota MMCORC on site identification and outreach.

This position requires travel across the state of Minnesota to help establish cancer clinical research regional sites.

This administrative appointment, depending upon qualifications, will be at the Associate or Professor compensation level, commensurate with experience. The qualified candidate will have a medical degree from an accredited medical school, board certification, current MD licensure in the state of Minnesota without restrictions or eligibility for state of MN license without restrictions, experience in oncology clinical trial execution and direction, and administrative experience in management of cancer clinical trials. Board certification in an oncology discipline is desired. Individuals may apply by going to the Employment System to search and apply for job opening 320440.

The University of Minnesota is an Equal Opportunity, Affirmative Action Educator and Employer.

Contact info: Dr. Douglas Yee, Director Masonic Cancer Center University of Minnesota jacob016@umn.edu

612-626- 5475

MINNESOTA PHYSICIAN NOVEMBER 2017

37

3Minnesota Medical Cannabis Program from page 31

Future reports Intractable pain became a qualifying condition for the program in August 2016, so patients who enrolled in the program for that reason are not included in the first year report. A report on intractable pain patients who enrolled in the program from August 1 through December 31, 2016 will be produced by the end of 2017. Post-traumatic stress disorder (PTSD) became a qualifying condition for the program in August 2017. A report on PTSD patients who enrolled in the During the first year, and program from August 1 through December 31, 2017 up to the present, no serious will be produced by the end of 2018. Going forward, adverse events (life threatening updated analyses with results for 6-month cohorts or requiring hospitalization) and for all patients to date will be produced. For the have been reported. latest reports, program updates, and information resources on medical cannabis visit OMC’s web site: www.mn.gov/medicalcannabis.

first year, and up to the present, no serious adverse events (life threatening or requiring hospitalization) have been reported.

Affordability

Unlike traditional pharmaceuticals whose costs are typically covered through insurance reimbursement, medical cannabis purchased through the Minnesota program is currently not covered by insurance and must be purchased out of pocket. The patient survey asked for a rating of product affordability on a scale of 1 (very affordable) to 7 (very prohibitive). More than half (51 percent) responded with a 6 or 7 and 86 percent responded with a score of 4 or higher.

“Bring the costs down” was a frequent response when patients and certifying health care practitioners were asked how the program could be improved. Some patients indicated on surveys they used less medical cannabis than they knew was helpful to them because they could not afford it.

Tom Arneson, MD, MPH, is research manager at the Minnesota Department of Health Office of Medical Cannabis. He provides a clinical and research perspective to implementation of the state’s medical cannabis program and

Program discontinuation Using a cutoff of six months with no medical cannabis purchases as a surrogate for program discontinuation, 51 percent of enrollees who made a first purchase during the first six months of the program discontinued participation in the program. This includes discontinuation due to patient death.

oversees research on the program’s impact.

OPTIMAL HEALTH and WELL-BEING

Our providers are people like you: Smart, compassionate, excellent at what they do and passionate about health care.

We see them as leaders and change agents.

You’ll play a critical role in crafting new strategic initiatives, programs and care delivery models – and making the decisions that impact the future of HealthEast.

We currently have opportunities in the following areas: n Family Medicine/ Internal Medicine – Outpatient n Hospitalist n Medical Director – Urgent Care n Hospice/Palliative Care

n n n n

Geriatric Psychiatry Psychotherapist 2 - part-time Cardiologist - Non - Invasive Pulmonary/Critical Care Physician

n n n n

Neonatal – NP Endocrinologist Medical Care for Seniors Physician Sleep Medicine

healtheast.org To learn more, visit us at healtheast.org/careers or call 1-866-610-7219 or email Marquita at mrwagner@healtheast.org

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NOVEMBER MINNESOTA PHYSICIAN

Helping physicians communicate with physicians for over 30 years.

Advertising in Minnesota Physician is, by far, the most cost-effective method of getting your message in front of the over 17,000 doctors licensed to practice in Minnesota. Among the many ways we can help your practice: •

• Recruit a new physician associate Share new diagnostic and therapeutic advances • Develop and enhance referral networks

Work. Life. Balance.

We’re looking for a Family Physician to join our provider team and help us continue a 60–year tradition of caring for our community at each life stage. You can change outcomes here. Relax your pace and balance your life in the beautiful Mille Lacs lake area.

Mission-driven contribution without large corporate complexities Time to focus on individual patients

Advertise!

Contact: Dr. Tom Bracken or Becky Fossand tbracken@mlhealth.org bfossand@mlhealth.org 320.532.2584 – mlhealth.org

IN MINNESOTA PHYSICIAN

(612) 728-8600

Minneapolis VA Health Care System Opportunities are available in the following specialties:

• Associate Chief of Ambulatory Care • Chief of Internal Medicine • Chief of Nephrology • Director of Primary Care Pain Management • Internal Medicine/Family Practice • Outpatient Clinics: Maplewood, MN (Rover); Chippewa Falls, WI; Superior, WI

US citizenship or proper work authorization required. Candidates should be BE/BC. Must have a valid medical license anywhere in US. Background check required. EEO Employer.

Minneapolis VA Health Care System (MVAHCS)

is a teaching hospital providing a full range of patient care services with state-of-the-art technology, as well as education and research. Comprehensive health care is provided through primary care, tertiary care and longterm care in areas of medicine, surgery, psychiatry, physical medicine and rehabilitation, neurology, oncology, dentistry, geriatrics and extended care.

Possible Recruitment Incentive • Competitive Salary Excellent Benefits • Paid Malpractice Insurance

For more information on current opportunities, contact: Rick Pope: Richard.Pope@va.gov • 612-467-1264 or Yolanda Young: Yolanda.Young2@va.gov • 612-467-4964

One Veterans Drive, Minneapolis, MN 55417

•

www.minneapolis.va.gov MINNESOTA PHYSICIAN NOVEMBER 2017

39

3Precision medicine in rural Minnesota from page 27 need it. Underlying this approach is truly understanding the health of the local population.

The cost Advancements in precision medicine come with a real financial cost. After the Human Genome Project was completed in 2001, advances in medical technology have grown exponentially. New testing criteria have been established but the costs have increased. Accessibility to the information and the vehicles for delivering the information also contribute to the cost. In rural areas, we need to utilize technology to provide access for patients, but that means ensuring that all of Minnesota has access to high speed Internet and other services. Thus, it is vital that we strategically integrate precision medicine into practices so that we can prioritize advancements in testing and therapeutics based on our rural population.

Collaboration among stakeholders The success of rural precision medicine is determined by the collaboration of health care stakeholders. Not all of the stakeholders have to be rural, but they influence the ability of rural health care providers to apply precision medicine in their daily care of patients. The stakeholders include the government, research industry, biomedical community, pharmaceutical industry, patient groups, and regulatory bodies. The strength of a rural health care community is its fundamental willingness to work together in the provision of care. We do it today and we will need to do even more of it in the future.

Conclusion As we advance toward integrating precision medicine into rural practices, we hope it will lead to increased health and wellness. The balance of the Institute of Medicine Triple Aim for patient care of improving population health and care, and reducing cost, will be essential in the development of rural precision medicine. We must be mindful that social determinants of health are intertwined with precision medicine so that we can strategically advance rural precision medicine.

The patient from Ely is doing well. She received testing and genetic counseling in Duluth and found that she carried a genetic mutation that placed her at higher risk of developing breast cancer. She was able to make an informed decision about her surgical choices and received chemotherapy that was known to be effective against her specific tumor type based on its genomic signature. Her sister is awaiting the results of whether she is a mutation carrier after participating in a telecounseling session with a genetic counselor and having her blood drawn by her local provider and sent for testing. This is what precision medicine can look like in rural Minnesota!

Paula M. Termuhlen, MD, FACS, is professor of surgery and has been regional dean of the University of Minnesota Medical School, Duluth Campus since April 2015.

She practices at Essentia Health St Mary’s Medical Center in Duluth, Minnesota.

Ruth Westra, DO, MPH, is associate professor and head of the Department of Family Medicine and Biobehavioral Health at the University of Minnesota Medical School, Duluth Campus. She practices at the Gateway Family Clinic in Moose Lake, Minnesota.

With more than 25 specialties, Olmsted Medical Center continues to experience significant growth. We are known for the delivery of exceptional patient care that focuses on caring, quality, safety, and service in a family-oriented atmosphere.

Rochester is a fast-growing community and provides numerous cultural, educational, and recreational opportunities.

Olmsted Medical Center offers a competitive salary and comprehensive benefit package.

Opportunities available in the following specialties: • Dermatology • Endocrinology • Family Medicine

• Internal Medicine • Gastroenterology • Occupational Health

• Ophthalmology Surgeon/ Refractive Surgeon

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

• Psychiatrist – Child & Adolescence • Psychologist– Adult • Urology

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

email: dcardille@olmmed.org • Phone: 507.529.6748 • Fax: 507.529.6622

www.olmstedmedicalcenter.org 40

NOVEMBER 2017 MINNESOTA PHYSICIAN

St. Health Cloud VA Care System Brainerd | Montevideo | Alexandria

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!

Opportunities for full-time and part-time staff are available in the following positions: • Internal Medicine/Family Practice

• Physician (Extended Care & Rehabilitation)

• Physician (Geriatric Evaluation & Management) • Physician (Hospice & Palliative Care)

• Physician (Pain Clinic/Outpatient Primary Care) • Psychiatrist

Applicants must be BC/BE.

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

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

Possible recruitment bonus. EEO Employer.

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

For more information:

Visit www.USAJobs.gov or contact Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301

218.365.8765 or pbanks@ebch.org

MINNESOTA PHYSICIAN NOVEMBER 2017

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3The rural Minnesota clinician workforce from page 25 that means discussing stipends and loan forgiveness for work commitment scenarios, to creating casual positions in your organization for aspiring clinicians to work during their school breaks. This past summer, we had two women about to enter medical school work in our hospital as casual “health unit coordinators.” These temporary staff members are excited to learn and gain real-life hospital experience by covering for vacationing staff. Perhaps best of all, this gave us the opportunity to showcase our people and facilities while determining if we want to invest further in these individuals. There is no easy solution to the recruiting dilemma, but our best advice is, when you think you’re being creative, get even more creative.

and friend. It’s important to try to provide what they may be looking for.

After you’ve done that, then you can impress them with your five-star patient satisfaction ratings, quality awards, well-equipped surgical suites, and patient care floors staffed with skilled and enthusiastic colleagues.

Bringing a new clinician on board

When you’ve decided to make the offer and it has been accepted, your work is not done. Onboarding can be stressful for the new physician, so work hard to make the transition to joining your clinic and community an easy one. In addition to coordinating house hunting trips, school visits, and other things to help them get settled, get together with a few of your most recent clinician hires and buy them lunch. Ask them to be honest with you about “the good, the bad, and the ugly” of joining your organization. Did they have enough training on the EMR? Was the tour of the facility and community a positive Putting your best foot forward experience? Did you fail to introduce them to someone early on who they Once you’ve identified a clinician candidate scheduled interview, 160 Firstand Street SE, Suitean 5, New Brighton, MN 651-383-1083-Main wanted to meet? What would have made onboarding a better experience Providers of Businessstaff Communication it is absolutely all hands on deck. An engaged medical during theSolutions – www.laserwave.net for them? Then, take what you’ve learned and implement it. It’s not rocket interview process is of utmost importance at this stage. The friendliest and science, but rather a deliberate and creative means to an end; the result of most supportive leadership team and welcoming community cannot offset 160 First Street SE, Suite 5, New Brighton, MN 651-383-1083-Main 160Suite FirstFirst Suite 5,MN New Brighton, 651-383-1083-Main 160First FirstStreet Street SE, Suite 5,New New Brighton, MN 651-383-1083-Main which isMN a MN clinician thatofwill potentially serveSolutions your community for decades 160 160 First Street SE, 160 SE, Suite 5,Street Street 5, SE, Brighton, New SE, Brighton, Suite 5, 651-383-1083-Main New MN 651-383-1083-Main Brighton, 651-383-1083-Main Providers Business Communication – www.laserwave.net Providers of Business Communication Solutions – www.laserwave.net an interview attended by a minority of potential practice partners displaying Providers ofBusiness Business Communication Solutions www.laserwave.net Providers Providers of of Business Communication Providers Communication of Business Solutions Communication Solutions ––www.laserwave.net – www.laserwave.net Solutions – www.laserwave.net and be a great partner as well.

HelloMakers Technology Decision Makers less-than-optimal engagement. And to further refine thisTechnology point, remember Hello Decision Hello Technology Decision Makers Hello Hello Technology Technology Hello Technology Decision Decision Makers Decision Makers Makers We market Digital Copier/Network Printer/Scanner Systems that the generations come into play. A millennial female physician amped up to practice OB in addition & to family practice will, perhaps, have more in Wide-Format Printers to savvy business owners Kevin Gish, MHA, LNHA, is administrator at Essentia Health Fosston. common with a similarly situated clinician than with a senior physician who We market Digital Copier/Network Printer/Scanner Systems We market Digital Copier/Network Printer/Scanner Systems We market Digital Copier/Network Printer/Scanner Systems We We market market Digital We Digital market Copier/Network Digital Copier/Network Printer/Scanner Printer/Scanner Printer/Scanner Systems Systems Systems Throughout Upper Midwest, and across North America. is winding down and has not practiced OBthe for over aCopier/Network decade.

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LaserWave Communications

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Essentia Health may be looking for more than a mentor, she may be looking for a160colleague First Street SE, Suite 5, New Brighton, MN Fosston.

651-383-1083-Main Throughout theNorth Upper Midwest, and across North America.

Throughout the Upper Midwest, andSolutions across America.

Providers of Business Communication – www.laserwave.net

Throughout thethe Upper Midwest, and across North America.

Throughout Throughout Throughout the Upper Upper Midwest, the Midwest, Upper and Midwest, and across across North and North across America.

America.

North America.

Hello Technology Decision Makers…

We are LaserWave Communications

LaserWave Copiers

We market Digital Copier/Network Printer/Scanner Systems & Wide-Format Printers to savvy business owners

Throughout the Upper Midwest, and across North America.

Use technology, don’t let technology use you!

Copier and printer advances occur daily–but is it worth buying or leasing a new machine when a refurbished one will significantly outperform your current machine for

75% BELOW RETAIL

After a Corporate Copier/MFP has just been “broken-in” but reaches the end of its LeaseTerm, it is typically returned to the Leasing Company.

We purchase directlythe from those After “broken-in” a Corporate Copier/MFP has just been “broken-in” but reaches the end of its LeaseAfter aCopier/MFP Corporate Copier/MFP has just been but reaches end of its LeaseAfter Corporate hasCopier/MFP justjust been “broken-in” but“broken-in” reaches thebut end ofits its LeaseAfter After aaWe Corporate aspecialize Corporate After Copier/MFP ain Copier/MFP Corporate has has just been been “broken-in” has “broken-in” just but reaches but reaches the end the reaches end of ofLeaseits the Leaseend ofmulti-function its Lease- We purchase directly from those “Lease-Return” and carry allbeen major brand-name, state-of-the-art leasing companies!

Term, it is typically returned to the Leasing Company.

Term, it is typically returned to the Leasing Company. We purchase directly from those Term, typically returned tothe the Leasing Company.

Wepurchase purchase directly from those Term, Term, ititisisit typically is typically Term, returned it returned is typically to to Leasing returned the Leasing Company. to the Company.

Leasing We We Company. purchase directly We directly purchase from from those directly those from those leasing companies! printer/copier/fax systems and wide printers. leasing companies!

Our Customers Typically Save 75%format or More!! leasing companies! leasing leasing companies! companies! leasing companies!

Our Customers Typically Save 75% or More!!

Our Customers Typically Save 75% oror More!!

Our Customers Typically Save 75% or More!!

Our Our Customers Customers Our Typically Customers Typically Save Typically Save 75% 75% or Save More!! or More!!

75% More!!

After a Corporate Copier/MFP has just been “broken-in” but reaches the end of its Lease-

We pick the brands and models with thecounts, features our customers demand Term, it is typically returned to the Leasing Company.

Webrands purchaseand directly from those • Windows and out MAC • Low-meter • All units refurbished with We pick out the models with the features our customers demand  the We pick out theand brands and models the features our customers demand  We We pickpick out theWe brands and models with themodels features ourthe customers demand leasing companies!   pick We out  out brands the pick brands and out models the brands models with and with the features the features with our customers our features customers demand our demand customers demandClean ensuring manycounts years of service and Showroom Compatible We endeavor to find the most favorable meter Our Customers Typically Save 75%the or most More!!  We endeavor to find favorable meter counts with endeavor tomost find the most favorable meter counts We endeavor to find themost most favorable meter counts • All come warranty • the Dealer certified Working As counts New • Hundreds of satisfied customers  units We  endeavor We endeavor We to We find toendeavor find the the to favorable find favorable meter most meter favorable counts counts meter o ALL of our copiers have more than 90% of their useful life left to give…. o ALL of our copiers have more than 90% of their useful life left to give…. 

 have We pick out the brands and models with of thelife features ourgive…. customers demand of our copiers have more than 90% their useful life leftleft to give….

ALL ofour our copiers more than 90% oftheir their useful left to oo ALL o ALL of ofo copiers our oALL copiers ALL have of our have more copiers more than than have 90% 90% of more ofthan their useful 90% useful life of left their life to left useful give…. to give…. life to give….

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Check usourout – the perfectly. perfectly. perfectly. amazing! perfectly. perfectly. perfectly. perfectly. We put our inventory through rigorous tests to ensure that they are functioning  The Copiers &out.

Printers are meticulously cleaned inside and out.   The Copiers & Printers Printers are meticulously cleaned inside and  & The &meticulously Printers areare meticulously cleaned inside and out. perfectly.

The Copiers & are meticulously cleaned inside andand out.  The  The Copiers Copiers Printers The &Copiers Printers Copiers are are & Printers meticulously cleaned meticulously cleaned inside inside and cleaned out. out. inside and out.

www.laserwave.net



(651) 383-1083

The Copiers & Printers are meticulously cleaned inside and out.

160 First St., SE, New Brighton, MN 55112 FreePeripherals Space Optics – VoIP Systems – Data Networks - Multi-Function Peripherals Free SpaceSystems Optics – VoIP Systems – Data Networks - Multi-Function Free SpaceSpace Optics ––Networks VoIP – -Data Networks - Peripherals Multi-Function Peripherals Free Space Optics –VoIP VoIP Systems Data - Systems Multi-Function Peripherals Free Space Free Optics Space –Optics –Systems VoIP Free Systems – –Data Optics Data – VoIP Networks - Multi-Function – Data Peripherals Networks - Multi-Function Peripherals Free Space Optics – VoIP Systems –Networks Data Networks - Multi-Function Multi-Function Peripherals

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NOVEMBER 2017 MINNESOTA PHYSICIAN

rehabilitate a body, we start T owith the mind and soul.

If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. Thatâ&#x20AC;&#x2122;s our approach.

Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.

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

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. Š 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553

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